The Alliance for Natural Health USA

Congressional Committee to FDA: Listen to ANH-USA and the Supplement Community!

ANH-USA — Tue, 18 Jun 2013 19:00:07 +0000

The committee that controls FDA’s purse strings is now turning up the pressure. Will we see change at last? Action Alert! The House Agriculture Appropriations Committee has released a report that, among other things, chastises the FDA for stalling on the second draft of their New Dietary Ingredient (NDI) guidance. The committee directed the FDA to end this “regulatory uncertainty,” issue a timeline for the NDI guidance, and include stakeholders in the process. Specifically, the committee told FDA to report back by September 1 on how the agency plans to “develop new methods of communicating with its stakeholders on future actions…including estimated timeframes for when regulations, advisories, and guidances are planned for release.” (NDI is included as an example of “guidances.”) The agency was also told to report back within sixty days of enactment of the Agriculture Appropriations bill with “a timeline on how it intends to re-engage the dietary supplement community to develop a final guidance on what constitutes a NDI.” This is a tremendously important development. It was ANH-USA’s work with the committee that got them to compel a second draft of the guidance, and it was our lobbyists who helped include the important language in this new report. This would not have been possible without your support and activism! THANK YOU! You would think that because the House Ag Appropriations Committee controls the FDA’s purse strings, the agency would have to listen to them. However, this same committee directed them to act before, and FDA did very little. Now, because the committee is turning up the volume, it pressures FDA to take action. FDA has now been specifically asked to provide a timeline, which would be hard for them to circumvent. We think it’s likely FDA will recognize that the committee is serious about all of this, and we hope that FDA will stick to the timeframe they provide. The committee’s mention of an “uncertain regulatory environment” refers to the FDA dragging its feet on the NDI draft guidance. It has been close to two years since FDA submitted its initial draft guidance, and the agency has been promising to work with the supplement community on a second draft since October 2012—eight months ago! An uncertain regulatory environment is, of course, not good for business. Companies don’t know what they can sell (and invest in) and what they can’t. Manufacturers will be less likely to submit NDIs for new supplements if they are unclear on what the requirements are. This will stifle innovation. And once again, consumers will be the losers. Also, despite their explicit promises to the contrary, FDA continues to enforce the controversial provisions of the draft guidance by sending out warning letters. For example, it issued letters to ten different companies for, in part, selling supplements that contained synthetic botanicals. The draft guidance says that synthetic botanicals are not considered to be a dietary ingredient at all (much less a new dietary ingredient), and therefore cannot be sold as an ingredient in dietary supplements. As written, the draft guidance puts a number of synthetic botanicals—all of which have important health benefits—in regulatory limbo, such as the following:

Epigallocatechin gallate (EGCg): EGCg is a potent antioxidant that is abundant in green tea and that may have therapeutic applications. EGCg is synthesized and commonly used in many supplements for its antioxidative qualities. It can protect the DNA in human cells from ultraviolet and visible radiation-induced damage.
Allicin: A sulfur compound obtained from garlic. Allicin is generated by the oxidation of diallyl disulfide for use in supplements and could be considered a synthetic botanical. In pure form it has been shown to have antibacterial activity, including multidrug-resistant enterotoxicogenic strains of E. coli; antifungal activity, particularly against Candida albicans; antiparasitic activity, including some major human intestinal protozoan parasites such as entamoeba and giardia; and antiviral activity.
Lycopene: While this phytochemical occurs abundantly in tomatoes, supplemental lycopene is usually synthesized from enzymes found in algae. Some studies show that lycopene lowers the risk of certain types of cancer and has a strong antioxidative effect.
L-theanine: This amino acid is found naturally in green tea, but in supplements is derived from fermentation of a tree leaf. In action, the result is chemically and, presumably, biologically identical. However, technically, it is both chemically altered and a synthetic botanical. L-theanine has numerous benefits, including helping to balance brain chemistry, reduce the risk of strokes, and reverse liver damage.

FDA has a history of enforcing its draft guidances via warning letters, even before they are finalized. For example, FDA has not completed its guidance distinguishing between dietary ingredients and beverages, yet the agency has cited the draft guidance in warning letters to supplement companies. And FDA has not issued final guidance on whether a dietary supplement is considered a food (in the context of determining when a food becomes a drug), yet has issued a warning letter to a supplement company on this issue. Don’t forget what is at stake in all this: FDA’s draft guidance threatens access to 29,000 supplements, and while FDA agreed to reconsider concerns and work with us and the supplement community, we still haven’t seen anything concrete. Our original concerns remain:

It’s unclear whether multiple NDI notifications will be required for the same ingredient if only the formulation has changed. Companies don’t know when and how they should submit NDI notifications.
The agency’s NDI draft guidance, as written, is a perversion of congressional intent. When the Dietary Supplement Health and Education Act of 1994 (DSHEA) was written, Congress envisioned a simple notification system that would ensure the safety of supplements, but FDA is trying to turn it into a de facto pre-approval system.
Additionally, the definition of “grandfathered dietary ingredients” is still unclear. FDA is supposedly working on a list of grandfathered ingredients, but the agency still has not released anything. Supplement companies don’t know whether popular products like resveratrol and P5P will be considered grandfathered and therefore protected—or subject to the endless red tape of NDI submissions.

ANH-USA will continue to actively participate in the process to ensure we receive the best guidance possible from FDA—one that protects the needs of the entire natural health community—in a timely manner. Action Alert! Please write to House Agriculture Appropriations Committee members, and thank them—in particular, the committee chair, Rep. Robert Aderholt (R-AL), and its ranking member, Rep. Sam Farr (D-CA), for their leadership—for including this important charge to FDA in their report. (Because this Action Alert is being sent only to the committee members, rather than the whole House, you will see a message if you don’t live in one of the committee members’ states.)

A Ban on Gingko? Even FDA Thinks It’s a Silly Idea

ANH-USA — Tue, 18 Jun 2013 18:00:02 +0000

So why has the media been jumping on the bandwagon? The Center for Science in the Public Interest (CSPI) wrote a letter this month to the FDA requesting a ban on gingko biloba. First the letter dismisses gingko’s efficacy on memory and cognitive function (“Claims regarding Ginkgo’s supposed health benefits…are false and should be stopped”), then cites a report that finds gingko extracts cause cancer in humans. Except that the report actually did nothing of the sort. The report, released in March by the National Toxicology Program (NPT, an interagency program overseen by the Department of Health and Human Services), linked extremely high dosages of one highly concentrated, specially formulated version of gingko biloba to an increased risk of cancer in the thyroid, liver, and noses of lab rats. A review clearly shows the many flaws in this research:

The gingko extract used in the study is not even remotely representative of the gingko extracts sold in the US. The supplier of the extract wanted to make a unique formulation that could be used for drug development. As this was a far more concentrated, synthetic version of gingko, it would be absurd to extend these results to all forms of gingko on the market.
There were issues with the stability of the formulation used. Moreover, the rat population received a much higher dosage than humans taking gingko in supplement form would receive, based on the dosage-to-weight ratio.
The particular rat population that was used is known for their spontaneous development of liver tumors.
The study authors explicitly state that the results should not be extrapolated to humans, and said that the review panel of the gingko was “specifically not to enter into any risk assessment related to humans.”

CSPI didn’t stop there. In their letter to FDA, they use the NTP report to make a broad attack on supplements and health claims. They mention dietary supplement companies and products by name, even though the gingko in the study was not the same formulation used in the products. Then CSPI shifted their attention to the media: “The dietary supplement industry is full of snake oil salesmen,” CSPI executive director Michael F. Jacobson told The Daily News. “It’s frustrating to see so many deceptive claims for dietary supplements.” CSPI is threatening to sue Bayer over their One a Day line of nutritional supplements. They say Bayer’s health claims “[fail to] satisfy the FTC’s requirements for substantiation in order to be lawful. The FTC has recently required a higher standard of proof for companies making health-related claims.” Unfortunately, media outlets as august as The New York Times gobbled up the story. However, the FTC required a higher standard of proof for only those few companies, and enforced that standard via litigation and a consent decree for each company. It’s not a regulation that applies to every company, much to the disappointment of FTC and apparently CSPI—but it is a deeply troubling precedent. We told you about CSPI’s agenda three years ago: they want the abolition of both Structure/Function Claims and Qualified Health Claims, which would eliminate almost entirely consumers’ access to information about what health considerations supplements support. Absurdly, they want food, supplements, and drugs to be treated exactly alike. In their view, no health claims of any sort should be allowed unless the product is brought through a full FDA approval process. Accordingly, when CSPI challenges a product’s health claims, it almost always cites the lack of a random controlled trial (RCT)—as if such a hugely expensive undertaking could be afforded for a natural food or supplement that has no patent protection! Despite CSPI’s professed “concern for consumers,” they have been silent on GMO labeling and have defended the government’s revolving door policy that allowed Michael Taylor to hop from Monsanto to the FDA. Happily, this time it doesn’t appear that CSPI will get its way. Even the FDA, that bastion of anti-supplement bias, has dismissed CSPI’s request to ban gingko biloba. An FDA spokesperson was quoted as saying, “It is not scientifically valid to conclude with certainty that dietary supplement products containing gingko biloba are unsafe based solely on data from the new NTP study.” Let’s look at a few other gingko studies to contextualize the NTP’s report:

Antioxidant extracts of the leaves of the gingko biloba tree may protect cells from radiation damage, according to a study published in the International Journal of Low Radiation.
In a randomized, double-blind, placebo-controlled crossover trial, researchers tested gingko in a cohort of twenty-seven patients with visual field damage resulting from normal-tension glaucoma. At the end of the study, the researchers noted a significant improvement in the ginkgo group’s visual field, and none of the participants reported any side effects from taking the ginkgo.
Gingko taken in combination with CoQ10, riboflavin (vitamin B2), and magnesium may reduce migraines.

As always, consumers should be sure to take only high quality supplements, together with the right cofactors, in consultation with a qualified health practitioner.

Distressing News: BPA in Mothers May Harm Newborns

ANH-USA — Tue, 18 Jun 2013 17:00:42 +0000

It’s time to take the BPA fight to the state legislatures. Action Alerts! Three recent studies paint a bleak picture about both the health risks and the prevalence of bisphenol A (BPA), a known endocrine disruptor. A Dutch study has found that fetuses of mothers who have high levels of BPA in their systems grow more slowly, have smaller heads, and weigh 20% less at birth compared with babies born to women with the lowest BPA levels. Moreover, BPA may have multigenerational effects. A study published in the peer-reviewed journal Endocrinology demonstrated that exposure to even very low levels of BPA during pregnancy results in adverse behavioral effects in mice carried forward over three generations. The multi-generational effects result from an epigenetic mechanism. In a third study, children and adolescents with high levels of urinary BPA showed evidence of low-grade albuminuria (where the kidney has experienced damage and is starting to spill some albumin into the urine). Damage at this early stage may have implications for the later development of kidney and cardiovascular disease. Despite growing evidence to the contrary, FDA’s assessment is that BPA is safe at low levels. The FDA rejected a petition from the Natural Resources Defense Council to ban BPA in food containers. ANH-USA’s petition to the Consumer Protection Agency was denied, and we still haven’t received a response to our OSHA petition regarding BPA in thermal register receipts. Given the federal government’s inaction, if we are to make progress on BPA, it will have to occur at the state level. This approach has already created positive change: the chemical industry voluntarily petitioned the FDA to limit BPA in baby food containers—and of course, since it came from the chemical industry, the FDA listened without commenting on the question of safety! Action Alerts! If you live in Connecticut, Massachusetts, New York, or Pennsylvania, please write to your state legislators and ask them to support these important BPA bills: Connecticut: S.16 would require all food containers containing BPA to be labeled as such. Take Action! Massachusetts: S.400 would ban BPA in toys, and mandate that manufacturers use the least toxic alternative as a replacement. Take Action! New York: A.1654 and S.4709 would prohibit the manufacture, sale, or distribution of business transaction paper containing BPA; S.3533 would prohibit the sale of toys, as well as liquids, foods, and beverages in containers that are intended for children 3 and younger if they contain BPA. This bill would also require manufacturers to use the least toxic alternative chemical compound to replace BPA. Take Action! Pennsylvania: H.377 and S.490 would ban BPA in children’s and toddlers’ products, and mandates that manufacturers use the least toxic alternative as a replacement. Take Action!

We had to sue the FDA for this info. Act now.

ANH-USA — Fri, 14 Jun 2013 19:46:26 +0000

The FDA is censoring speech at the expense of consumers' health. Enough is enough—it's time for concrete action. Donate now!

Dear Readers:

Recently, I asked for your help to raise $40,000: the FDA is shredding free speech to limit supplement access, and we need your support to file legal petitions—the first step to suing the FDA for this double threat to your rights. Hundreds have responded generously, but we still need your help!

You may be wondering: “Why should I donate? What difference will it make?”

To answer these important questions, I want to share an example of the incredible impact thousands of individuals can have when they stand together with ANH-USA.

It’s a well-known fact that folate or folic acid supplementation for pregnant women is vital, as it can prevent serious neural tube birth defects. But did you know the FDA tried to keep this important information from consumers, and fought so hard against it that we had to sue them?

In 2000, ANH-USA and renowned constitutional lawyer Jonathan Emord sued the FDA because they were forbidding makers of folate/folic acid supplements to claim that intake by pregnant women may prevent certain birth defects. We won, and now health claims concerning folate/folic acid are allowed on supplement labels.

This illustrates three things:

How far FDA will go to censor free speech. The FDA will go to great lengths to suppress scientific speech concerning dietary supplements. They seem to want to maintain Big Pharma’s monopoly at the expense of consumers.
It’s not just the First Amendment at stake. Since this victory, we’ve seen an increase in the number of pregnant women taking a folate supplement—and, more importantly, a decrease in neural tube birth defects! Like this victory, our new petitions to the FDA will have a real impact on countless families.
When we unite, we can stand up to the “Powers that Be”—and win. We’re continuing with ANH-USA’s winning legal strategy, with a twist: this time we’re pursuing multiple petitions and multiple angles—including a challenge to the FDA’s entire health claim system.

This summer, you have a new opportunity to change lives. We’ve won before, and we can win again—but only with your help. Won’t you be a part of this historic battle?

Your donation will be 100% tax deductible— every single penny goes straight to the Natural Health Alliance Foundation, the charity that supports ANH-USA’s legal projects. Any size gift will make a huge difference— $5, $50, $500, or more.

The need is great—please give generously!

On behalf of ANH-USA, thank you—we deeply appreciate your activism and generosity. I personally promise that your hard-earned cash will be put to the best use possible: to defend your freedom of speech and your freedom to make informed health decisions.

With gratitude for your continued support,

Liz Ardagna Membership Director, ANH-USA

P.S.: Want to honor a friend or loved one? Make a gift in honor of someone who inspires you to fight for what’s right, and we’ll let your honoree know that you’ve made a commitment to protect natural health in his or her name. Many thanks!

Is FDA About to Greenlight a Drug Banned in Other Countries?

ANH-USA — Tue, 11 Jun 2013 23:44:19 +0000

If enough people raise their voices in protest, we can prevent it. Action Alert! Remember the controversial diabetes drug Avandia? In 2010 we told you about two FDA drug safety reviewers who warned the agency that Avandia posed serious risks of heart attack and heart failure when compared with other diabetes drugs. Since then, the drug has been removed from the market in most countries and has been under severe restrictions in the US. Last Thursday, in a combined meeting of separate FDA advisory committees, 20 of 26 panelists voted to recommend removing or modifying Avandia’s highly restrictive label and distribution system. Five voted to keep the restrictions in place, while one panelist voted to remove the product from the market altogether. There has been only one large, randomized trial for the safety of rosiglitazone, the drug that is marketed as Avandia. That trial—sponsored by GlaxoSmithKline (GSK), the drug’s manufacturer—was called RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes). Serious flaws were found in RECORD’s methodology, its results were questioned, and the trial was widely discredited. In 2010, FDA required GSK’s RECORD results to be reexamined and re-adjudicated. What was the FDA’s motivation for reviewing Avandia? GSK didn’t request that the drug be reviewed. Could it be, as Steve Nissen suggests in Forbes, because FDA “is seeking to avoid accountability for its role in the Avandia tragedy”? FDA’s official position is that they asked for the re-adjudication because of “the public interest in Avandia, the extensive history of the product, and the continued uncertainty of the risk surrounding this drug.” Duke University’s Clinical Research Institute (DCRI) was selected for the re-adjudication, and they found that the risk for cardiovascular death, myocardial infarction (MI), and stroke to be virtually the same as the original study concluded. Because these new results reaffirmed GSK’s findings that the drug was no more unsafe than other diabetes products in its class, Thursday’s panelists were sufficiently reassured that the drug was safe enough to lift restrictions. Unfortunately, other data paint a very different picture:

In 2005 and 2006 GSK secretly conducted an analysis of cardiovascular safety of Avandia, and concluded that the drug increased the risk of heart attacks and related events by 30%. Since two-thirds of diabetics eventually die of cardiovascular complications anyway, this 30% hike is terrifying.
In 2006 GSK informed the FDA’s Center for Drug Evaluation and Research (CDER) of the secret analysis, but FDA and CDER agreed to conceal this hazard from patients and practitioners.
During a public hearing, independent FDA statisticians reported an 80% increased risk of heart attack. Avandia is estimated to have caused 83,000 heart attacks in the United States alone.
Adverse effects caused by the drug are currently the subject of over 13,000 lawsuits against GSK. As of July 2010, GSK has agreed to settlements on more than 11,500 of these suits.
Last year, GSK pled guilty of criminal conduct, partially for concealing the hazards of Avandia. The company paid a $3 billion fine—the largest in US history.

In addition, the re-adjudication process itself was biased. GSK prepared the study materials before submitting them to Duke for analysis, rather than allowing the university to review the raw data. (On the widespread problem of publication bias, see our article in this issue.) On top of that, key members of the 2010 advisory committee that decided to place restrictions on Avandia in the first place were not part of the 2013 meeting. Of the twenty-seven member panel, fourteen of the experts were on the panel last time, and they were the people with a more favorable attitude toward Avandia. This is in contrast to the other experts who did not serve on the panel a second time—like Steven Nissen, who was one of the most outspoken critics on the panel. FDA claims all panelists were invited, it does not appear they made a huge effort to ensure their participation; Nissen says he was not re-invited. With all of the big nay-sayers out of the picture, it’s no surprise the panel voted to lift the restrictions on this dangerous drug. FDA should focus more on advisory panelists who have true conflicts of interest. A 2007 law placed caps on the number of waivers that could be granted allowing experts with conflicts of interest; a 2012 law removed those safeguards. When there are no restrictions on experts with conflicts of interest serving on FDA advisory panels, more drugs with dangerous side effects could certainly enter the market. Action Alert! The FDA is not obligated to follow its advisory committee’s recommendation, though they usually do so. Moreover, there is no regulatory deadline by which they have to make a decision. If there is enough public pressure, perhaps this will force the FDA to reject the advisory committee’s decision on Avandia—or at least postpone any action indefinitely. Please send your message to the FDA about the dangers of Avandia!

Danger: Cherry-Picked Drug Studies!

ANH-USA — Tue, 11 Jun 2013 23:33:58 +0000

Drug companies are deliberately keeping the public—and the medical community—in the dark about “unfavorable” clinical trials. Action Alert! The RECORD trial (see our article in this issue) is just one example of how drug study data can be manipulated by pharmaceutical companies and the FDA. But it gets worse—even if a study finds a drug isn’t very safe or effective, it’s likely you and your doctor will never hear about it. The problem—called publication bias—is widespread. About half of all drug trials aren’t made publicly available, and positive findings are twice as likely to be published as negative findings for the same drug. Since doctors can access only a small portion of the full scientific picture, they are led to believe that drugs are much safer or more effective than they actually are. This results in a huge gap between what the FDA knows about drugs and what prescribing doctors know. For example, one independent study looked at all drug trials submitted to the FDA for twelve antidepressants. Thirty-eight of the trials showed positive results, while thirty-six showed negative results. Yet thirty-seven of the positive results were published in peer-reviewed journals, while only three of the negative studies were! Any doctor looking at the published studies would be led to believe that antidepressants were overwhelmingly effective. This is especially troubling considering the many negative effects of antidepressants—including suicidal behavior, and evidence of violent behavior against others. Other manufacturers suppress drug trial information as well. A congressional investigation into the cholesterol drug Vytorin revealed that its manufacturer, Schering-Plough, deliberately hid results showing that the drug didn’t improve artery health, and continued to market Vytorin heavily. A trial on Multaq, a drug that treated irregular heartbeat, was stopped because more patients who received the drug were dying than those who received a placebo—yet this incredibly important study was not published until five years later! Even if you don’t rely on patented medicines, this widespread deception costs you a great deal of money. Look, for instance, at Tamiflu, an antiviral influenza drug. The Cochrane Collaboration, which reviews drug trials, attempted to collect all data, both published and unpublished, from all Tamiflu trials. The results of the negative trials simply weren’t publicly available. When they started obtaining the trial write-ups via the Freedom of Information Act, the true effectiveness of the drug became murky. Tamiflu appears to be no more effective than aspirin—yet it has been stockpiled by governments around the world. The UK had contracts for over 50 million doses of Tamiflu—enough for 80% of the population—and the US has stockpiled over 37 million doses, costing taxpayers $1.5 billion. In many cases, drug studies are retracted after they are published. Researchers found that nearly 75% of retracted drug studies were pulled because of scientific misconduct such as data falsification or fabrication, questionable veracity, unethical author conduct, or plagiarism. And such scientific fraud is on the rise: according to the most recent data, the number of scientific retractions is fifteen times higher than in 2001. Last fall, the Senate Finance Committee slammed medical device manufacturer Medtronic for ghostwriting entire studies to support its Infuse bone graft system, and for getting other authors to take credit for the research to give the appearance of impartiality. When a new drug seeks FDA approval, FDA requires drug manufacturers to submit basic results of all the clinical trials they sponsor. Companies can sponsor as many trials as they like, many of which can have negative results—which the public almost never sees. But so long as two of the trials show that the drug is effective, the drug is usually approved! Even worse, this requirement only applies to drugs approved after 2007. Most drugs currently on the market were approved before 2007. Action Alert! Write to your senators and representative and ask them for new legislation to require that all drug trials submitted to the FDA be publicly available—not only for new drugs, but for all drugs currently on the market. There is no reason a government agency should keep secret information that could affect the health of its citizens. Send your message today!

If Dr. Offit Had His Way, Vitamins Would Be Treated as Drugs

ANH-USA — Tue, 11 Jun 2013 23:28:06 +0000

The New York Times has published another shameful op-ed bashing nutritional supplements. Here’s our response. This week, Dr. Paul A. Offit, chief of the infectious diseases division of the Children’s Hospital of Philadelphia (and author of a forthcoming book called, hilariously enough, Do You Believe in Magic?: The Sense and Nonsense of Alternative Medicine), wrote a piece for the New York Times called “Don’t Take Your Vitamins.” In his article, Dr. Offit states, “Nutrition experts argue that people need only the recommended daily allowance —the amount of vitamins found in a routine diet. Vitamin manufacturers argue that a regular diet doesn’t contain enough vitamins, and that more is better.” This statement is offensive (not to mention patently incorrect) on multiple levels:

We do not get enough nutrients from our food. The soil in factory farms is depleted of nutrients, resulting in less nutritious vegetables. The runoff from CAFOs and their animals, together with the pesticide residue on plants, produce foodstuffs that are considerably less safe and healthful than their organic counterparts.
Many Americans do not eat a healthy diet, and instead consume primarily processed foods—resulting in severe nutrient deficiency. A 2005 USDA report found that 93% of Americans have an inadequate intake of vitamin E, 56% have an inadequate intake of magnesium, 44% have an inadequate intake of vitamin A, 31% have an inadequate intake of vitamin C, 14% have an inadequate intake of vitamin B6, 12% have an inadequate intake of zinc, and 8% have an inadequate intake of folate.
The notion that “nutrition experts” agree with the recommended daily allowances (RDAs) is absurd—the Academy for Nutrition and Dietetics adhere slavishly to RDAs. The vast majority of nutritionists and naturopaths provide treatment through vitamin and mineral supplementation, often recommending dosages well above the RDA.
In fact, RDAs are not the best way to determine optimal levels of vitamin and mineral intake. RDAs are based on extraordinarily conservative recommendations from the Institute of Medicine and spring from a deeply flawed risk assessment approach. As Robert Verkerk, executive and scientific director at ANH-Int’l, notes in his critique of this approach, there is a “tendency for risk assessments to be undertaken on ‘nutrient groups,’ rather than discrete ‘nutrient forms,’ despite considerable variation in biological response between nutrients within given groups.” For example, a risk approach that analyzes one more potentially dangerous form of niacin at higher dosages (nicotinic acid) discriminates against other forms of the same nutrient (inositol hexanicotinate).
Dr. Offit fails to distinguish between using nutritional supplements to maintain optimal health versus using supplements just to prevent disease (e.g., rickets), which is a much lower bar. He also ignores the fact that each individual has different nutritional needs and therefore different supplementation needs.

Dr. Offit cites a few studies indicating that vitamin E is linked to an increased risk of mortality, heart failure, and prostate cancer. Yet ANH-USA won a qualified health claim—in court, based on science—that vitamin E may actually reduce the risk of cancer! The Life Extension Foundation (LEF) cites numerous studies that soundly contradict Dr. Offit’s assertions and show the protective effects of multivitamin supplementation. A large intervention trial published in the Journal of the American Medical Association in 2012 discussed a randomized, double-blind, placebo-controlled trial in which over 14 000 US physicians took either a multivitamin or placebo each day and were followed for an average of 11.2 years. The doctors who took a multivitamin had a statistically significant reduction in total cancer incidence compared to those who took a placebo pill. Then there’s the 2010 study published in the American Journal of Clinical Nutrition in which over 31, 000 women aged 49–83 revealed cardiovascular benefits of regular multivitamin use. In this study, women without a history of cardiovascular disease who took a multivitamin for more than five years had about a 40% reduced risk of heart attack. Moreover, Dr. Offit referred to the Proxmire amendment, which prevented FDA from regulating megavitamins as drugs based solely on their potency (i.e., if they exceeded a certain potency, they would be considered a drug) as the agency’s biggest failure. We would call this a tremendous victory. The Proxmire amendment ensured that we would have access to high-dosage vitamins and minerals that could not go through the exorbitantly expensive drug approval process because, as natural substances that cannot be patented, manufacturers could never charge enough money to recoup the money spent in clinical trials. As LEF notes, Dr. Offit ignores data that conflicts with his agenda. He only cites studies that suggest negative effects of supplementation and excludes important evidence to the contrary. This approach, LEF opines, may have been influenced by the fact that he will soon be publishing a book bashing alternative medicine. The entire piece seems to have been written to promote interest in his new book.

Our LTE to the Washington Post

ANH-USA — Tue, 11 Jun 2013 15:58:28 +0000

Regarding the Consumer Reports article, “Dietitians can provide skilled advice on how to eat more healthfully” [June 3], reprinted in Washington Post: Instead of encouraging consumers to improve their health via nutritional advice tailored to their personal needs and resources, this “article” is a thinly veiled advertisement for the Academy of Nutrition and Dietetics (AND). It summarily dismisses the diverse, highly credentialed, and rapidly developing field of non-RD nutrition professionals, while finding no worse criticism for nutritionists than “they may suggest you take vitamins.” Perhaps Consumer Reports simply did not realize the following: to the AND (a trade association for dieticians, not a medical organization), nutritionists are competition: competition they strive to eliminate through a campaign of monopolistic state nutrition licensing laws. (1) Considering the AND has recently been criticized by the media for accepting sponsorships from junk food companies (those continuing education classes the AND boasts of? They’re brought to you by Coca-Cola), they’ve probably been hoping to eke out some positive press. (2,3) However, we encourage all those seeking nutrition advice to conduct their own research and choose a nutrition health professional with the education, credentials, and experience with which they are personally comfortable. Gretchen DuBeau, Esq. Executive Director, Alliance for Natural Health USA, Bethesda DuBeau's group advocates for natural-health practitioners and consumers. (1) Forbes.com Is The ADA Intentionally Using State Legislatures To Block Alternative Nutrition Providers? http://www.forbes.com/sites/michaelellsberg/2012/07/10/american_dietetic_association_2/ (2) NY Times Report Faults Food Group’s Sponsor Ties http://www.nytimes.com/2013/01/23/business/report-questions-nutrition-groups-use-of-corporate-sponsors.html?_r=1& (3) Actual Continuing Professional Education classes from RD’s from Coke’s “Beverage Institute”: http://beverageinstitute.org/us/webinar/childrens-dietary-recommendations/

FDA Violates Free Speech to Limit Supplement Access. Take Action!

ANH-USA — Thu, 06 Jun 2013 12:00:16 +0000

The FDA is trampling free speech to limit your access to supplements. But ANH-USA has a bold new legal strategy. Will you join us in this historic battle?

Dear Readers, Did you know that if a supplement company “Likes” a customer’s Facebook post, it magically transforms nutritional supplements into drugs? The same thing happens if a supplement’s website links to a scientific article! As recently as this week, the FDA has made attacks like these to expand the agency’s definition of “disease claim.” Why? By saying a supplement makes a disease claim, the FDA can call it a “drug”—and then remove it from the market! This also has scary implications for the government regulation of Internet searches and speech. If supplement companies start deleting customer comments out of fear of FDA action, then the FDA has effectively limited consumer speech by using the company as a censorship puppet.

The FDA is pushing your First Amendment rights closer and closer to the edge. Will you push back, before it’s too late? It doesn’t stop there: the FDA has something called its Evidence-Based Review System. It’s just a backdoor tactic to require prohibitively expensive studies—as in hundreds of millions of dollars—if companies want to make any claim about the science behind their supplements. Because natural products can’t be patented, supplement companies can never recoup these astronomical costs. Only Big Pharma and their blockbuster drugs can afford to “pay-to-play:”

We’ve had enough. How about you? Here’s our plan: ANH-USA will submit multiple petitions—strategically supported by our ongoing legal activities—to address, from various angles, FDA’s egregious First Amendment violations. If we win, we ALL win. If the petitions are denied, we’re ready to pursue further litigation. Immediate action is critical. Unfortunately, this is an expensive project. This is why we need your help!

Our goal is to raise $40,000 by June 14, so we can kick off our FDA petitions to defend free speech and supplement access.

Please make a tax-deductible gift today! Any amount—even just a few dollars— makes a huge difference. The FDA’s actions leave consumers in the dark about the dietary supplements they are buying for themselves and their families. This can be a matter of safety—for you and the ones you love. The FDA is halfway down the slippery slope of taking away consumer access to supplements. Will you join us in saying, “Enough is enough!”? Yours in the fight, Liz Ardagna Membership Director, ANH-USA P.S.: As an extra bonus, through June 14, your qualifying donation earns you a reusable tote bag, BPA-free water bottle, picnic blanket, or yoga mat that lets you proudly show off your support for ANH-USA. Please make your gift today!

A New Bill Would Include Nutritional Supplements in Health Savings Accounts

ANH-USA — Tue, 04 Jun 2013 21:28:34 +0000

Health Savings Accounts are especially important for natural health consumers—and now they may become even more useful. Action Alert! Senator Orrin Hatch (R-UT) and three of his colleagues have introduced S 1031, a bill that would allow Health Savings Account (HSA) funds to go toward dietary supplements without having to get a doctor’s prescription; the same would apply to Health Flexible Spending Accounts (FSAs). The legislation, called the Family and Retirement Health Investment Act of 2013, does this by expanding the term “medical care” to include dietary supplements, and it would allow spending up to $1,000 each year. A companion bill, HR 2194, was introduced in the House by Rep. Erick Paulsen (R-MN). Sen. Hatch and Rep. Paulsen introduced similar legislation in 2011. Our concern at the time was that the president’s Affordable Care Act could invalidate HSAs altogether, making this legislation irrelevant; even Congress wasn’t sure whether HSAs would survive. As we explained then, the law that created HSAs made eligibility dependent on having a high-deductible (“catastrophic”) insurance plan; under the Affordable Care Act, catastrophic plans were effectively eliminated, and we weren’t sure if any of the plans that qualify under ObamaCare would be considered high-deductible enough for HSAs. However, now that the Affordable Care Act rules have started being issued, it looks as if HSAs may be saved—most likely because of strong activist support from readers like you. Based on the actuarial analysis, some high-deductible plans may qualify as allowable bronze level plans on the insurance exchange. (These are insurance plans where the patient pays 40% of the bill, and the insurance plan picks up 60%.) Many experts, including the Centers for Medicare & Medicaid Services, point to high deductible plans as one of the key factors slowing US healthcare spending. The share of employees enrolled in high-deductible plans surged to 13 percent in 2011 from 3 percent in 2006. This is important legislation because so many natural health advocates depend on HSAs and FSAs—they can be used for integrative doctor visits and treatments not covered by conventional insurance. And of course nutritional supplements are an integral part of natural health. Expanding HSAs to include supplements will increase consumer access and choice, not to mention overall consumer health. HSA plans slow the growth in healthcare spending. A 2012 study from the Rand Corporation found that families with consumer-directed health coverage like HSAs and FSAs spent an average of 21% less in the first year after switching from traditional coverage. The study found that if even half of consumers who had employer-sponsored coverage were in such plans, healthcare costs would fall by $57 billion. Employers may also be waking up to these cost savings. Fully 66% of large companies offered one HSA-based plan option this year; this is expected to increase to 80%. Smaller companies have been shifting to HSAs as well. Action Alert! Write to your senators and representative and ask them to support the Hatch bill (in the Senate) and the Paulsen bill (in the House). Remind them that nutritional supplements are one of the cornerstones of an integrative approach to health, and can help reduce healthcare spending if consumers take a preventive approach to health using supplements. Please contact your legislators immediately!

Update: Victory for Connecticut GMO Labeling—Other States, Take Note!

ANH-USA — Tue, 04 Jun 2013 21:18:03 +0000

Yesterday, Connecticut passed a law requiring foods with genetically engineered ingredients to be labeled—and it’s all thanks to your grassroots activism! Connecticut has taken a first important step. The House version of its Label GMO bill (which ANH-USA helped draft) passed the Connecticut Senate unanimously on Saturday, and passed the legislature 134 to 3 on Monday. Our hope is that this bill will inspire neighboring states to take similar action so the trigger can come into effect as quickly as possible. The bill now goes to Gov. Dannel P. Malloy’s desk to be signed into law, and there good reason to believe he will do so—he has already issued a statement of support of the bill. Unfortunately, the House version had the provision requiring four states to pass similar GMO labeling laws, so long as those states in the northeast region have a combined population above 20 million (it was originally 25 million, but the language was amended). We would have preferred that the legislature had passed the stronger Senate version of the bill, which carried the standalone provision we told you about last week, but this nevertheless sends a strong message that Americans demand to know what is in their food! Once again, we must give you the credit for your superb response to our Action Alert. Now—residents of other states in the Northeast, start petitioning your legislators for a GMO labeling bill in your state!

Which Chemicals in Your Home Are Toxic? EPA Doesn’t Know!

ANH-USA — Tue, 04 Jun 2013 21:14:40 +0000

In a rare showing of bipartisanship, the Senate hopes to repair a hopelessly broken system. Action Alert! Sens. Frank R. Lautenberg (D-NJ), who died this week at the age of 89, and David Vitter (R-LA) recently introduced legislation to address toxic chemicals in household and manufacturing products. S 1009, the Chemical Safety Improvement Act (CSIA), will try to plug the holes in the thirty-seven year old Toxic Substances Control Act (TSCA), one of the few pieces of legislation that has never been amended. While this new bill is a big step in the right direction, we have some concerns that we request Congress address. Chemicals are used to produce 96% of manufactured consumer goods. Many of them are toxic. In 1976 Congress passed the TSCA to regulate the introduction of new or already existing chemicals. However, the TSCA does not separate chemicals into categories of toxic and non-toxic—it simply prohibits the manufacture or importation of chemicals that are not on the TSCA Inventory. Under the TSCA the government must, for the most part, prove that a chemical is unsafe before it can be removed from market, instead of requiring manufacturers to prove that their chemicals are safe in the first place. In fact, manufacturers often do not provide data to the EPA regarding toxicity, so it’s hard for EPA to have information on the safety of the chemical or show “unreasonable risk.” EPA has been able to require the testing of about 200 chemicals, and has taken action against only five chemicals or chemical classes, even though there are now roughly 85,000 chemicals on the market. In other words, the current law is broken. Because these chemicals are mostly new to nature, one cannot assume they are safe for humans or the environment without studies. This new bill will require safety evaluations on all existing chemicals, which will be labeled either high or low priority in terms of risk to human health. For high-risk chemicals, EPA must conduct further evaluations. If a chemical is determined to be unsafe, EPA is then empowered to take action—from a labeling requirement to a phase-out of the chemical to an outright ban. However, the bill does not create mandatory deadlines for completing safety assessments and determinations. While the justification is that the review periods for different chemicals vary, and the EPA is more likely to abide by their own established deadlines, in reality it is far too easy for the government to needlessly drag out the review of chemicals. Under the Chemical Safety Improvement Act, new chemicals entering the market must undergo a safety assessment, and EPA will have the authority to prohibit unsafe chemicals from being sold. Unfortunately, the bill does not (though it should) require determination of the aggregate and cumulative exposure to chemicals—something earlier TSCA reform bills did consider. Aggregate exposure looks at one’s exposure to a chemical from different sources and different routes, and cumulative looks at simultaneous exposure to different chemicals that affect the body through same modes of action. The agency will also be empowered to get the necessary health and safety information from chemical manufacturers, while at the same time balancing manufacturers’ needs for proprietary information. Under the bill, EPA will take special care to properly evaluate the risk to vulnerable populations like children and pregnant women. The bill also allows EPA to exempt chemicals from risk management under certain circumstances (e.g., national security, economic disruption). But the EPA does not have any burden of proof to justify their exemption. We would ask that the bill require EPA to show “clear and convincing evidence” that the chemical falls under an exemption. If the federal government makes a law and there is already a state law on the books on the same issue, the federal law preempts the state law. With the TSCA, a state can petition the EPA for an exemption of TSCA’s preemptive effect so long as three conditions are met: the state requirement does not violate federal law; the state requirement provides a “significantly higher degree of protection from such risk than the requirement under federal law”; and interstate commerce is not unduly burdened. Our greatest concern about CSIA, the new bill, is that the preemption language is more inclusive and carries a broader standard. Under CSIA, no state may require additional information on a chemical or additional development of test data when companies have to submit similar information to the EPA. Moreover, states cannot create new restrictions or even enforce existing restrictions on the manufacture, processing, distribution, or use of a chemical after EPA completes its safety determination for the chemical. Arguably, this could even limit a state’s ability to require chemical warning labels on product labels—companies could argue that this is part of “distribution.” A state can request a waiver from these limitations if the state law does not burden interstate commerce, and there are compelling state or local conditions, and the requirement is supported by “the best available science and is supported by the weight of the evidence.” This is an extraordinarily difficult bar to meet. Instead, the new preemption language should be struck from the bill so it reverts to the preemption language under current law. Besides its strong bipartisan support, the bill is enjoying the unique position of having the support of both industry trade associations and a number of public advocacy organizations. That’s a good thing—we like the bill in general, but we hope our concerns about the bill will be addressed. Toxic chemicals can be found in a tremendous number of everyday products from BPA in food containers to flame retardants on our furniture, which can spread to the dust on the floor that children can ingest when playing. Flame retardant chemicals have been linked to lower IQ and the development of diabetes. Toxic chemicals can cause a number of health problems, and exposure to chemicals in the womb can have long-lasting affects on the child’s life. This bill will go a long way toward getting rid of, or at least identifying, the toxic chemicals that citizens may be encountering on a daily basis. Action Alert! Write to your senators and ask them to support the Lautenberg bill with amendments that address our serious concerns. Tell them that you work hard to keep your family safe from dangerous chemicals, but this bill is desperately needed to help ban the truly toxic ones. Please contact your senators immediately!

What to Do if Your Drug Has Too Many Dangerous Side Effects?

ANH-USA — Tue, 04 Jun 2013 21:09:19 +0000

Simple—you ship it to third world countries! The manufacturers of two human papillomavirus (HPV) vaccines, Merck (Gardasil) and GlaxoSmithKline (Cervarix), have found a new market: they struck a deal to offer their HPV vaccines to developing countries at much reduced prices. They hope that by 2020, 30 to 40 million girls in developing countries will be getting vaccinated. Even at the reduced prices of $4.50 (Gardasil) and $4.60 (Cervarix), this will mean a massive increase in Merck and GlaxoSmithKline’s revenues. The primary reason Big Pharma is looking for new markets is because a majority of girls in the US are not being vaccinated against HPV. This appears to be mainly due to the risk of side effects. Dr. Diane Harper, lead developer of Gardasil, has stated that the HPV vaccine is associated with Guillain-Barré Syndrome, and has resulted in deaths. The Vaccine Adverse Event Reports for Gardasil supports this and in addition notes a propensity for blood clots. The US Center for Disease Control says that adverse event reports are not peer reviewed science but then refuses to study them so that they can be peer reviewed. It was the government of course which first developed this expensive and dangerous vaccine, which licensed it to a drug company, which then fast tracked approval for it despite protests about the placebo used (a toxic substance itself) and then recommended requiring it for teenagers. HPV has been back in the news this week mainly because of Michael Douglas’s announcement that the throat cancer he battled was caused not by his lifelong smoking and drinking—both of which are significant contributors to oral cancer—but by HPV contracted through oral sex. (Afterward, he backpedaled a bit on that statement through a spokesperson.) However, according to a study in the Journal of Clinical Oncology, while recent increases in incidence and survival of oropharyngeal cancers in the US have been attributed to HPV infection, the empirical evidence is lacking. On top of that, HPV is linked to only one type of throat cancer—upper throat cancer—and not all oropharyngeal cancers. Sadly, the media has taken this opportunity to stump for wider acceptance of HPV vaccines, despite the fact that 75% of sexually active men and women become infected with HPV at some point, but most clear the infection on their own within two years—their immune system handles it. On top of that, the media almost never discusses the side effects of the vaccine, or its poor success rate. Could this be because major media are kept alive with drug company advertising and drug makers also make vaccines? Of the 100+ different types of HPV, only fifteen might someday develop into cancer; moreover, the Journal of the American Medical Association says the relationship between infection with HPV at a young age and later development of cancer is unknown. Of those fifteen potential cancer-causing strains, the vaccine targets only two: HPV-16 and HPV-18. In other words, the vaccine will have no effect on 87% of the HPV viruses that might potentially cause cancer, and the causal link between HPV and the later development of cervical cancer is far from definitive. By contrast, regular pap smears have no side effects and can easily catch cervical cancer in time. Even women who have had HPV vaccine should still do pap smears since the vaccine doesn’t protect against all cancer-causing HPV strains. According to Dr. Jonathan Wright, patients with HPV should turn to vegetables—particularly those of the cruciferous family—because they influence the metabolism of estrogen, which in turn hinders the growth of HPV viruses. One study showed that a natural substance found in cruciferous vegetables, indole-3-carbinol (13C), which can also be taken in supplement form, can help treat HPV-associated tumors. Early research indicates that 13C may potentially reverse and even cure HPV-related cervical cancer. Dr. Wright believes that the curative powers of13C may be even more potent in its active form, known as DIM, or di-indolylmethane. As always, individuals need to weigh the risks with the benefits and make up their own minds, armed with as much information as possible.

Washington State Medical Board Further Disgraces Itself

ANH-USA — Tue, 28 May 2013 21:00:09 +0000

It blames medical legend Jonathan Wright, MD, for its own misconduct. Action Alert! In April we told you about the battle that integrative physician and natural health pioneer Jonathan Wright, MD, has been facing in Washington. The state’s Medical Quality Assurance Commission (MQAC) finally issued its ruling last week. In short, Dr. Wright’s license will be suspended for ninety days (effective mid-June). Following that suspension, he will be on probation for thirty months. He must pay a $7,500 fine; he must appear before MQAC annually to report on any new NDs or MDs his clinic has hired; and—absurdly, to our mind—he must submit a paper to the Commission describing the importance of proper licensure! Dr. Wright will definitely be appealing this ruling. The appeal will be to a “real court” in Washington State not an administrative agency. As you know, administrative agencies are the prosecution, judge, and jury all in one entity. “Real” courts are not! MQAC, of course, has unlimited legal resources. Doctors, especially integrative doctors, are not generally rich. They use this fact to try to bully beleaguered integrative doctors in the state, most of whom they have attacked, into settling on MQAC’s terms. You can help by donating to Dr. Wright’s legal defense fund. Here’s the background on the case, which you may recall from our earlier article. Dr. Wright’s Tahoma Clinic had hired a medical doctor who had been licensed outside Washington State, under the condition that he apply for a Washington medical license. He did so, and the doctor’s Washington license was listed as “pending” on the MQAC website. During this period, Dr. Wright followed the legal advice he had received and monitored him closely as required by Washington law. Suddenly, MQAC charged Dr. Wright with “aiding and abetting the unlicensed practice of medicine” because the doctor’s out-of-state license had been revoked. At least four MQAC staff members admitted during the hearing they knew from the beginning that the doctor’s out-of-state license had been revoked and that he could therefore not be licensed in Washington, but never put that information on the MQAC website (which continued to describe the physician’s Washington license as “pending”) or told Dr. Wright about it. It is MQAC that is culpable of “aiding and abetting the unlicensed practice of medicine,” not Dr. Wright! While much of the hearing held last March centered on allowing this doctor to work at the clinic, MQAC also charged that Dr. Wright had been “non-cooperative” because he redacted private patient information when he gave MQAC the records of patients the physician had seen. These two allegations formed the basis of MQAC’s complaint. However, when MQAQ finally handed down its decision, the Commission did not sanction Dr. Wright for either alleged violation. Instead, they found him guilty of a new infraction, which had never even been raised in MQAC’s charging documents: failure to follow a vague statute that governs the practice of an out-of-state doctor whose license is pending. And what do these rules say? The statute says the out-of-state doctor must not solicit nor take on patients in his own name, and must not open his own office. The thing is, Dr. Wright followed this statute to the letter. So in effect MQAQ has sanctioned him for a charge they didn't make in the first place, and which he is completely innocent of. Why did MQAC change direction like this? We can only guess. But one possibility is that it recognized its own culpability in leaving the doctor’s name on its license pending list, when it knew that the doctor had lost his license in another state and therefore could not be licensed in Washington. So it just adopted another, completely spurious charge. And why, by the way, did MQAC leave the doctor on its license pending list and not tell Dr Wright what it knew? Again, we can only speculate. But given MQAC’s history of harassing Dr. Wright on spurious grounds (the last complaint before this one was over his phone system!), one can only wonder if there was a deliberate attempt to entrap Dr. Wright. If so, it has backfired. It is MQAC that has entrapped itself, as we hope the courts will realize. We aren’t lawyers, but we wonder if MQAC has not engaged in criminal behavior. This is a sad day for Washington State, which is usually considered a progressive place open to alternative ways of thinking such as integrative medicine. Who would want to live in a state with a governing agency like MQAC? Dr. Wright is a champion of natural medicine. He has developed innovative and successful natural therapies utilizing food, supplements, and lifestyle changes for a host of maladies that conventional medicine cannot cure. Now he needs your help. Please give to the Dr. Jonathan Wright Legal Defense Fund!

GMO Labeling Bill Passes the Connecticut Senate—and You Helped Draft It!

ANH-USA — Tue, 28 May 2013 20:00:16 +0000

Now on to the CT House—where the opposition is stronger. Action Alerts!

It’s good news/bad news in Connecticut for GMO labeling advocates this week, where the state Senate voted 35-1 in favor of SB 802, a GE labeling bill that ANH-USA helped draft. After the Senate passed the bill, the Connecticut House accepted an amendment from Governor Dan Malloy and Speaker Brendan Sharkey, despite strong protest from advocates, that weakened the bill.

The amendment was a triggering provision which requires that three more of the nine states that make up the Northeast—Maine, New Hampshire, Vermont, Massachusetts, Rhode Island, New York, Pennsylvania, and New Jersey—would need to pass a similar bill before it could go into effect in 2015. However—and this is back to the good news—if the other states failed to adopt GMO labeling statutes, the Connecticut GMO law would still go into effect on its own, but in 2016, as a standalone provision. This provision rescues the bill. SB 802 is sitting in the House, waiting for a vote.

However, on Friday around midnight, the House passed and sent to the Senate its own bill, HB 6527. This bill is weaker than SB 802 because it removes that all-important standalone provision, and increases the number of states needed to trigger the GMO labeling requirement to five. Moreover, before Connecticut citizens would have the right to know what is in their food, the combined total population of at least two of those five states would have be at least 25 million people! This also appears to be a deal worked out between the governor and Rep. Sharkey.

Action Alert! Connecticut residents, please contact your representatives and thank them for supporting GMO labeling in HB 6527, but ask them to vote YES on SB 802 since this the stronger bill and provides the greatest protections to consumers! Take Action!

Also please contact your senators and thank them for passing SB 802. Thank you to CT Senate!

Connecticut seems to be following a familiar pattern. Maine’s GMO labeling bill (LD 718) recently passed out of committee 8-5—with the same proviso that it will go into effect only if three more of its nine neighboring states pass similar laws by 2018.

So far, Vermont hasn’t put the same restriction into its GMO labeling bill. Vermont’s House just passed H 112 by 99-42. The bill is now in a great position to be taken up by the Senate when lawmakers return to their work next January.

On the federal level, however, the picture isn’t as bright. The Sanders amendment to the Agriculture Reform, Food, and Jobs Act of 2013, which would have permitted states to require the labeling of GMOs, failed with a vote of 71-27.

Rep. Steve King (R-IA) added an amendment to the Farm Bill, which has passed through committee and is waiting on the floor of the House for a vote. The King Amendment would “reinforce the Commerce Clause by asserting the right of a state to trade agriculture products freely with another state. One state cannot deny the trade of an agricultural product from another state based on that product’s means of production.”

This amendment may well have negative implications for GMO labeling. A state that requires GMO labeling on its food, it could be argued, creates a trade barrier between a state that does not require GMO labeling. This could run up against the dormant commerce clause, which limits individual state authority to regulate intrastate commerce even in the absence of a conflicting federal law. This is a back-door way of dissuading states from passing labeling laws. It could also prevent states from banning GMO products altogether.

Action Alert! Please contact your representative immediately and ask him or her for an amendment to strike the King Amendment from the House Farm Bill.

Are Big Pharma’s Drugs Making Your Heartburn Worse and Worse? Just Fix It with Surgery!

ANH-USA — Tue, 28 May 2013 19:00:14 +0000

Now they want to cut open your throat and install a metal ring with magnets, when the best and safest natural remedies cost pennies! Gastroesophageal reflux disease, or GERD, affects at least 20% of adult men and women in the US population, according to the International Foundation for Functional Gastrointestinal Disorders. It also occurs in children. It’s the backflow of stomach contents (usually accompanied by heartburn) into the esophagus, and can cause tissue damage which may eventually lead to cancer. This kind of cancer has been increasing rapidly and threatens to become an epidemic. There are reasons to think that current treatments for heartburn are directly leading to the cancer. Much of the current thinking about heartburn centers around the idea that one’s lower esophageal sphincter (LES) is defective—which leads to its not shutting properly—allowing stomach acid to flow back into the esophagus and burn the esophageal lining. So researchers have invented a procedure in which an expandable metal ring of titanium beads with magnetic cores is clipped onto the bottom of the esophagus. The ring of magnets pull inward to close the esophagus but can expand to allow food to pass downward. The New England Journal of Medicine recently published a study showing that 86% of patients with GERD who had the metal ring implanted no longer used heartburn medicine one year after the implant. Over three years, most patients showed lower acid levels in their esophagus, and patients who continued taking heartburn medication were able to lower their doses. There were some downsides, however: six patients experienced pain, vomiting, and difficulty swallowing, and ultimately had the device removed. Two-thirds of all who received the implant reported difficulty swallowing, though this fell to 11% after one year, and 4% after three years. The study was far from ideal. The researchers excluded everyone who was obese, and everyone who had advanced inflammation of the esophagus or a large hiatal hernia (a bulge, which is associated with GERD). In other words, they didn’t even study the very populations who need a treatment for GERD the most. We would also note a rather telling irony: the study was not a random controlled trial (RCT), which is mainstream medicine’s idea of the “gold standard.” Even so, the results are being announced as if it were a great triumph. When it comes to natural treatments, one of conventional medicine’s main critiques is that no RCTs have been done, even though the critics know the expense is too great for non-patentable supplements! This is not the first time surgery has been suggested as a treatment for GERD. Last year we told you that surgeons were trying to seal the valve with sutures. Mainstream medical treatment for GERD and heartburn has up to now been to use drugs to decrease stomach acidity, either by neutralizing stomach acid (antacids) or shutting down the stomach’s ability to produce acid through proton pump inhibitors (PPIs). The study is quick to say this new surgery is a way to get patients off stomach acid drugs. It may be they’re finally acknowledging that the popular acid blockers, the PPIs in particular, are dangerous. They have a number of highly undesirable side effects, as documented by academic research, including reduced calcium absorption (which is associated with an increased risk of bone fractures in women); reduced absorption of other critical minerals and nutrients; an increased risk of vomiting and diarrhea; an increased risk of pneumonia (because an acid-free stomach lets pathogens into our body); and an increased risk of dementia in elderly African Americans and probably in others. An article published in the Journal of Gastrointestinal Surgery also showed that these medications increase bile reflux and that this bile reflux is particularly dangerous for the throat. Other drugs can also increase your risk for reflux and throat cancer, including pain relievers (NSAIDS) and bone medications called bisphosphonates (e.g., Fosamax), as integrative physician Dr. Frank Shallenberger points out in his publication “Stop the Stomach Torture.” Common sense tells us that acid is in our stomachs for a reason. We need it for digestion. Moreover, acid production declines, sometimes sharply, with age, while stomach problems including GERD increase sharply with age. If stomach problems are more often associated with declining acid production, how can completely shutting off acid production improve the situation? In time, we will look back on the almost promiscuous use of acid-blocking drugs, among the drug industry’s biggest sellers, as one of modern medicine’s most colossal and inexcusable errors. Neither the drugs nor the surgery address the question of why people have a “defective LES” in the first place. Most likely, it’s a simple case of needing more stomach acid, not less, in order to keep the valve shut. If there is enough acid in the stomach, the stomach probably signals the valve to shut. If there isn’t enough acid, this won’t happen. As we noted last year, the lack of acid in the stomach, where it is meant to be, means that the stomach may fail to signal the pyloric valve at the top of the stomach to close when you are digesting food. Failure to close may also be linked to an overgrowth of helicobacter bugs (associated with ulcers) which do not like acid and are able to reduce your stomach acid production. In some people, it could also be caused or exacerbated by food allergies and sensitivities, or by too much caffeine, alcohol, nicotine consumption, or other drugs, as mentioned above. In other words, the very drugs being prescribed by conventional medicine could be offering temporary relief but at the cost of exacerbating the problem over the long term. Why do they even provide temporary relief? Because when the stomach lacks the acid and enzymes released by the acid needed for digestion, it falls back on a secondary mechanism of fermentation. This works to get the food through but creates gas and discomfort. The acid blockers probably make you feel better by temporarily stopping the fermentation. Bottom line: promoting an invasive and unreliable surgical throat ring is not exactly a solution for a problem probably caused in the first place by acid-blocking drugs. Alternative remedies for GERD will vary, of course, depending on each individual’s symptoms. You’ll need to see an integrative physician, but their recommendations may include:

Supplements containing hydrochloric acid and enzymes to control GERD and restore the digestive system; melatonin to help strengthen LES function; and vitamin C and beta carotene;
Deglycrrhizinated licorice (DGL), zinc, carnosine, chamomile, and aloe vera, which may also help ease heartburn;
D-limonene, an extract from the orange peel. Evidence suggests it provides a barrier in the stomach and esophagus against bacterial infection and may reduce the amount of gastric juices that reflux into the esophagus;
Testing for food allergies; and
A healthy, low-carbohydrate diet free of processed foods, with lots of green, leafy vegetables.

An excellent book on this subject is Your Stomach: What is Really Making You Miserable and What to Do About It by Dr. Jonathan Wright, MD, published by our friends at Praktikos Books.

Baby-Bottle Makers Ban BPA.

ANH-USA — Thu, 23 May 2013 15:16:08 +0000

While the FDA dillydallied on reviewing its earlier ruling that bisphenol A (BPA) poses no threat to health, researchers at the National Institutes of Health — basing their findings on 2009 findings — linked BPA to the interference of brain development both in newborns and the unborn. As a result, the attorneys general of Connecticut, New Jersey and Delaware wrote a joint letter to the six primary manufacturers of baby bottles, urging them to stop using BPA in their products. The six companies — Avent, Disney First Years, Gerber, Dr. Brown, Playtex and Evenflow — have now volunteered to ban BPA from their baby bottles. Connecticut Attorney General Richard Blumenthal has called the action “a major public-health victory”. The European Food Safety Authority and the FDA still maintain that BPA poses no harm to humans. Nearly one year after American Association for Health Freedom (ANH-USA) petitioned the FDA to remove BPA from dental sealants and composite fillings used in children’s mouths, the agency has yet to respond.

Compounding Pharmacy Bill: Third Draft, Still Some Major Problems—and No Time to Lose!

ANH-USA — Tue, 21 May 2013 17:00:05 +0000

The compounding pharmacy bill (S.959) passed the Senate Health Education Labor and Pensions Committee on Wednesday, May 22 with no substantive changes. The bill will likely be taken up in the Senate soon—Action Alert! Senate bill S. 959 is a large and complex piece of legislation on compounded drugs. As we reported last week, the second draft was much improved over the first, thanks to your messages, but unfortunately the final draft does not fix the remaining problems. In particular, the bill allows the FDA to disallow entire categories of compounding drugs in “complex dosage forms” such as extended release products or transdermal patches. Millions of women and men depend on compounded time-release thyroid medications in both the complete and active forms, neither of which is available in standard drug form. Another concern: estriol (the bioidentical hormone) has a USP-NF monograph, so legally it can be compounded. But this bill would allow FDA to identify bulk ingredients that are “drugs not suitable for compounding” based on unnecessarily vague “public health concerns,” even though they have a monograph as estriol does! In the past, the FDA has attempted to ban bulk bioidentical estriol at the request of a pharmaceutical company. The current language of the bill could allow FDA to regulate away your access to that medication, currently used by millions of women who refuse to take the synthetic hormone drugs that have been proven to be so dangerous. We must not let the FDA take away bioidentical estriol. We believe this bill simply provides the FDA, which has been historically biased against supplements and integrative medicine, too much discretion to ban compounded drugs, including complete thyroid medications as well as estriol and other hormones. We still need to amend the language to ensure that only compounded drugs for which there is very good reason to believe they can cause harm to consumers should be banned, but we urgently need your help once again—and this alert goes out to the entire Senate, not just the HELP Committee. Your message to your senators is critical. Please take action immediately!

What Will Be in Your Organic Produce, Fish, and Fortified Grains if Codex Gets Its Way?

ANH-USA — Tue, 21 May 2013 16:30:01 +0000

Pesticides? Yes. GMOs? Maybe. Hormones? Maybe not. ANH-USA’s executive and legal director, Gretchen DuBeau, was a member of the US delegation to the Codex Committee of Food Labeling (CCFL), which met in Canada last week. We were honored to bring the voice of the consumer to the table at Codex, especially since it is otherwise heavily influenced by big corporate interests. The CCFL is responsible for setting organic food labeling standards—similar to our National Organic Standards Board, but on an international level. Food labeling, in this case, encompasses health claims and nutrient reference values, with a significant focus on GMOs. The committee works very closely with the Codex Committee on Nutrition and Foods for Special Dietary Uses (CNFSDU) by developing the labeling and defining the claims permitted in foods and dietary supplements. You may recall that ANH-USA represented you at the CNFSDU meeting last November in Germany. At this meeting, four areas of concern were discussed:

GMO labeling;
Whether the pesticide ethylene may be used on organic produce;
Organic standards for aquaculture and seaweed; and
Biofortification of grains.

GMO Labeling After years of heated debate, we thought the CCFL had finally put the issue of GMO labeling to rest: rather than adopting an official position, the committee decided to leave it to the discretion of individual countries. This year, however, there was a short-lived attempt to allow countries to label GMOs in accordance with national legislation. Regarding non-fermented soybean products, for example, the working group wanted to include this language: “If genetically modified soybean is used in the process, it shall be indicated in the label in accordance with national legislation.” This language is hardly a mandate—it simply states that if GMOs are used, they should be labeled if the host country has GMO labeling laws. But surprisingly, a number of member countries were outraged at the hint of anything that could possibly support GMO labeling, and the language was rejected. The US used its standard (and patently false) “GMO is not materially different” argument. Argentina was even more extreme, stating that the current Codex standards on biotechnology is actually discriminatory. They want to see more pro-GMO language in Codex! Use of Ethylene The committee also discussed whether to allow ethylene as a sprouting inhibitor for organic potatoes and onions, and if so, how it should be labeled. Ethylene is a widely used gas commonly employed to hasten the ripening of fruits. In the US, it is considered a pesticide, and is currently allowed in organic foods for the post-harvest ripening of tropical fruit and the de-greening of citrus. However, ethylene is toxic enough that the CCFL was also considering whether labeling should reflect worker safety concerns. Should a substance that is potentially hazardous to workers even be used in organics? The European Union is pushing for the qualified use of ethylene in organic foods. Their data, however, was seriously lacking. They did not have any first-hand toxicological data on mammals, only secondary sources and reviews, and those indicated that ethylene exposure may result in asphyxia as well as an increased risk to the liver and nervous system—though they were unable to determine at what level this occurs. And they had no studies of the behavior of ethylene in the environment, though they predicted that the use of ethylene would be “unlikely” to contaminate water and soil “in significant amounts.” Given that European Food Safety Authority itself identified data gaps in areas of significant concern, it is premature to allow the use of ethylene as a sprouting inhibitor for organic potatoes and onions. The desire to have certain potatoes and onions out of season should not override environmental and health risks. Aquaculture and Seaweed The CCFL is in the beginning stages of including aquaculture (the farming of aquatic organisms such as fish, crustaceans, mollusks, and aquatic plants) in its standards for organic foods. By contrast, the US has still not developed certification standards for organic aquaculture products, even though we started the process back in 2000. During last week’s discussions, the US asked for the explicit inclusion of animal feed as part of organic standards. In general, Codex guidelines have usually been applied to feed as well, but it is certainly not a bad thing to have it be included specifically in the language. For this request to come from the US is surprising, since organic feed for carnivorous fish has proved problematic in the US. Fish feed is not usually organically farmed—often they are wild-harvested feed fish. Current US organic standards demand that all certified organic livestock be fed 100% organic feed; the US hasn’t issued a final rule on this is as it relates to aquaculture. Conventional fish are often grown in overcrowded tanks. Some members felt that the amount of individual space fish receive should be higher (the “stocking density” should be lower) for organic fish than for conventional aquaculture. Unfortunately, the US disagreed, citing a lack of scientific support. The committee is considering deleting any reference to a limit on stocking density, stating that the current organic standards protecting animal welfare are sufficient. No agreement has been reached on the use of hormones in organic aquaculture and seafood. Canada pushed for the qualified use of hormones (supported by Japan and Brazil), but we are happy to report that the US was opposed to permitting hormones (as were other countries), since hormones contradict the market expectations of organic foods. Biofortification The CCFL is currently discussing the issue of labeling of biofortified foods. Biofortification is the idea of breeding crops to increase their nutritional value. Biofortification differs from ordinary fortification because it focuses on making plant foods more nutritious as the plants are growing, rather than having nutrients added to the foods when they are being processed. The problem is that there is not even an accepted definition of biofortification. Biofortification can occur through traditional, natural crossbreeding and seed selection (“conventional biofortification”); the addition of nutrients during the processing of crops; or through genetic engineering. ANH-USA’s position on the subject would depend largely on which process is used. In any case, the labeling of the biofortified food is important. Labeling would need to indicate three things: that it was biofortified; how it was biofortified (natural vs. GE); and what it was fortified with. The conventional biofortification of crops is positive: it provides a natural, safe way to deliver necessary vitamins and minerals to vulnerable populations without processing. For example, the HarvestPlus program (developed by the International Food Policy Research Institute, an observer at Codex meetings), also produces crops biofortified with iron and zinc. In fact, we could argue that biofortification through conventional breeding or processing is a relatively inexpensive and time-tested methodology—human beings have literally been doing it for millennia with great success. And it is a safe alternative to GE. By contrast, it would be irresponsible to accept GE biofortification without evaluating its long-term safety to humans and to the environment. Codex (short for Codex Alimentarius, the Latin for “food code”) is a commission established in 1963 by the United Nations Food and Agriculture Organization and the World Health Organization with a stated mission of protecting the health of the consumers and ensuring fair practices in the food trade. As we explained last year, this is done by developing harmonized international food standards, guidelines, and codes of practice, and wherever there is a proposed “harmonization,” we must be vigilant. Codex guidelines and standards are also used as benchmarks in World Trade Organization disputes—and as a WTO member, the US must toe the line. On top of that, Codex standards may influence domestic law. Right now, the European Union’s absurdly low allowable dosages for vitamins, minerals, and other supplements influences Codex, which may in turn influence or affect our own laws—and that would be a disaster. We will, of course, keep you posted on what is happening as all this develops.

Repeal the Monsanto Protection Act!

ANH-USA — Tue, 21 May 2013 16:00:34 +0000

A new bill could overturn this egregious law right away. Action Alert! In April, we reported that the secret provision known as the Monsanto Protection Act, a rider anonymously attached to a spending bill that sailed through Congress in March, had ignited a firestorm of outrage from the public. This new law strips federal courts of the authority to halt the sale and planting of illegal, potentially hazardous genetically engineered crops even while USDA is performing an environmental impact statement. ANH-USA has spoken with the office of Sen. Jeff Merkley (D-OR), and we have confirmed that the senator is planning to introduce an amendment to the upcoming Senate Farm Bill which would repeal the provision. The Monsanto Protection Act is set to expire at the end of September, with the temporary spending measure, but might be rolled in to the next one if we don’t act. If we can we get rid of it now, it would be a signal from the American people that nothing like this sneak provision, stuck without warning into must-pass, unrelated legislation, should never again be attempted. Sen. Merkely needs to build support for the amendment to improve its chances of being voted on when the Farm Bill goes to the Senate floor next week. This year’s Farm Bill is nearly identical to the 2012 version that passed the Senate but not the House. The most significant change in this year’s Farm Bill is the end of direct payments to farmers, who have traditionally been paid whether they grow crops or not. The program costs American taxpayers about $5 billion a year. The new bill would instead increase financing to farmers for crop insurance, a federally subsidized program that pays insurance premiums for farmers and covers decreases in crop revenue. In addition, the funding levels of the Supplemental Nutrition Assistance Program (SNAP) in the 2013 Farm Bill are extremely controversial. The program, which serves 47 million Americans, gives $70 billion a year in food stamp assistance, which amounts to about 70 percent of Farm Bill spending and eclipses the crop insurance program. The House Agriculture Committee wants to cut $20.5 billion in food assistance over the next ten years to rein in SNAP’s growth. Republicans say the cuts to SNAP should be bigger while Democrats argue they’re already too big. The Farm Bill will be moving quickly, so we need to take immediate action. Please send a message to your senators today and ask them to support Sen. Merkely’s amendment to repeal the Monsanto Protection Act!

ANH-USA Uncovers Suspicious Activity by State Dietetic and Health Boards

ANH-USA — Thu, 16 May 2013 00:06:07 +0000

Our exclusive report reveals government surveillance, what appear to be undercover sting operations, and investigations into the alleged crime of “practicing nutrition without a license.” Action Alerts! ANH-USA has uncovered widespread surveillance (including undercover sting operations), aggressive investigations, and prosecutions of nutrition professionals. These actions, together with the levying of criminal penalties, have been undertaken by state health departments and state dietetics boards that are enforcing monopolistic laws sponsored by the Academy of Nutrition and Dietetics. More often than not, they are supported by local law enforcement or the offices of state attorneys general. The AND—formally the American Dietetic Association, or ADA—is not a medical organization, but a trade group that represents the interests of Registered Dietitians (RDs, who are certified by the AND’s credentialing arm). The AND has about 74,000 members. These non-RD nutrition professionals are being targeted by these states’ RD monopoly laws, despite the fact that many of them have advanced degrees and a tremendous number of clinical hours to their credit. They are being prosecuted for “practicing dietetics without a license” or for referring to themselves as “a nutritionist” in media or marketing materials. One of the AND’s key agenda items is to pass “scope-of-practice” laws in each state whereby only RDs can legally offer nutrition services—even basic services like providing nutrition advice or nutrition consulting. The AND describes this as a “Mega Issue” for the organization, and it was listed as priority at the AND’s recent conference in Washington, DC. If an RD monopoly bill is passed by a state’s legislature and signed into law by the governor, a dietetics board is created to enforce the new law. Unsurprisingly, these boards are mostly comprised of RDs (on Georgia’s board, six of its seven members are RDs). They have the weight of state law behind them, and depending on the state, the dietetics boards can levy heavy fines against a nutritionist who is not an RD and can either file criminal charges themselves or can refer the case to the state attorney general for prosecution for violating the state’s law of “practicing dietetics/nutrition without a license.” See, for example, the dietetics laws in Florida (468.517: Prohibitions; penalties), Georgia (43-11A-15: Refusal, suspension, or revocation of license; other disciplinary actions) North Carolina (90-366: Violation a misdemeanor), and Ohio (4759.09: Violation procedure). The AND defends its RD monopoly law and the creation of these dietetics boards as an effort to “protect the public health.” However, in our investigation into three years of records from four state dietetics boards, we did not find a single case of an unlicensed nutrition practitioner causing harm or engaging in a harmful nutrition related activity, and not a single case of a customer filing a complaint. Every complaint that spurred a subsequent investigation and prosecution was made at the behest of the Board itself, or from complaint forms submitted by RDs. (At least one AND affiliate has openly encouraged its members to submit complaints against fellow nutrition professionals). Let’s be clear: ANH-USA generally supports the AND’s desire to protect the term “Registered Dietitian” or “Dietitian.” We believe it helps inform consumers as to the professional training of that nutrition practitioner. At the same time, we adamantly oppose efforts by any nutrition organization to limit consumer choice by enacting laws that benefit one particular group. We believe in a competitive and open market for nutrition professionals, with consumers and employers (including hospitals) being able to decide what credentials, education, and experience they want in a nutrition provider. As we’ve noted, there is no evidence whatsoever that an open and competitive market for nutrition services endangers the public safety and health. But do dietetics boards improve the public health? Let’s look at a public health issue that is the sine qua non of nutrition professionals: obesity. Five of the ten most obese state (MS, LA, WV, AL, MI, OK, AR, IN, SC, KY) have RD monopoly laws. Nine of the ten least obese states (AZ, CT, NV, NY, UT, CA, NJ, MA, HI, CO) do not. It would seem that ADA-run dietetics boards are not having a positive impact on public health, and may be having quite the opposite effect. Not only is Colorado the least obese state in the country, it’s also one of three states (Arizona and New Jersey are the other two) that do not regulate the practice of nutrition whatsoever. If the AND were correct, and a lack of regulation of nutrition endangers the public safety, then Colorado should be the epicenter of harm—yet it seems the reverse is true. In fact, in a 2007 letter, the Colorado Department of Regulatory Agencies rebuked the Colorado Dietetic Association, which was at the time seeking an RD monopoly law, for failing to provide any evidence of harm caused by the unlicensed practice of nutrition professionals. Currently only twenty-four states have restrictive nutrition counseling laws. That’s because most states recognize that this push has nothing to do with protecting the public health, and everything to do with market share. Nearly thirty years ago, in the Journal of the American Dietetic Association 84:4, the organization’s president wrote (emphasis ours):

Like other professionals, dietitians can justify the enactment of licensure laws because licensing affords the opportunity to protect dietitians from interference in their field by other practitioners. Licensure also can protect dietitians by limiting the number of practitioners through restrictions imposed by academic, experience, and examination requirements. This protection provides a competitive advantage and therefore is economically beneficial for dietitians.

When the news broke about the investigation (and attempted silencing) of blogger and Paleo diet proponent Steve Cooksey by the North Carolina Board of Dietetics/Nutrition, we had a feeling he wasn’t the first non-RD targeted by dietetics boards. Were there people like Steve Cooksey in other states? ANH-USA filed freedom of information requests with state dietetics boards that had histories of aggressively targeting non-RD nutrition practitioners. Our requests sought any and all information on complaints, investigations, enforcement actions, and internal communications related to RD monopoly laws. We received thousands of pages of documents, meeting minutes, email communications, complaint forms, cease-and-desist orders, and consent decrees relating the enforcement of restrictive nutrition practice and speech laws by dietetics boards in Florida, Georgia, North Carolina, and Ohio. We also scoured the Internet for records—including those found on the boards’ public websites. Here’s what we discovered: Florida Florida’s Dietetic & Nutrition Practice Council is part of the Florida Department of Health; the latter carries out investigations and enforces the state’s RD monopoly law. Our investigation revealed that undercover operations—with individuals posing as potential patients or clients seeking personalized nutrition advice so as to entrap the unlicensed practitioner—were conducted by RDs who had filed complaints against non-RD nutrition professionals, as well as by investigators from the Department of Health itself. Undercover surveillance might be excused if the public health were really at risk. But as Forbes contributor Michael Ellsberg noted, “The reason to surveil and report citizens who provide public nutrition advice (people like Steve Cooksey) is not that there’s any evidence that these citizens actually harm the public. Rather, the reason to surveil and report citizens like Cooksey is that doing so is necessary to maintain licensure laws (which were designed by the ADA explicitly to limit market competition).” At a Dietetic & Nutrition Practice Council meeting this past January, a board member stated that in 2012, the Department of Health spent 681 hours, at a cost of $19,857, to investigate complaints of people practicing nutrition/dietetics without a license. Previous year’s totals were 191 hours in 2010, and 207 hours in 2011. That’s a 229% increase in investigations in just two years! Last year the Florida Department of Health fined at least seven people at a total of $11,672 for the crime of referring to themselves as a nutritionist or offering “nutrition services” without a license. There were no allegations of harm and not a single complaint filed by individuals who visited these “unlicensed practitioners.” Ohio Our investigation revealed that since 2009, there have been 349 investigations by the Ohio Board of Dietetics. At least forty-two of the investigations were of non-RD practitioners accused of practicing nutrition/dietetics without a license—including wellness centers, alternative health providers, physical trainers, and other licensed professionals. To date, seven official disciplinary actions, such as cease-and-desist orders and consent decrees, have been issued by the board. Ohio was singled out as “a model dietetics board” for its aggressive investigations into unlicensed activity at the AND’s Public Policy Workshop this past March. In addition to its questionable investigations against non-RD nutrition professionals, we should highlight what seems to us to be a flagrant conflict of interest on the part of the Ohio Board of Dietetics. A bill that was introduced in the state legislature, HB 259, would have allowed non-medical practitioners who do no harm to practice in Ohio. The bill was supported by health freedom advocates, but opposed by the state Ohio Dietetic Association, a 501(c)6 trade group that can legally lobby for and against bills. However, our investigation revealed that the Ohio Dietetics Board—a state government entity—actively lobbied against HB 259, which is patently against the law. This is outrageous enough, but we’ve also learned the board was coordinating its lobbying activities with the Dietetics trade group—the same group the board is supposed to regulate. The bill passed the Ohio House, but failed in the Senate, and the bill died in 2012. ANH-USA has filed an ethics complaint with Ohio state agencies over the Board of Dietetics’ collusion with a private trade association in an attempt to limit competition. ANH-USA is also preparing materials for review by the Federal Trade Commission into possible restraint of trade actions by both the state dietetic association and the state board. Georgia The office of Georgia’s Secretary of State responded to our freedom of information request with the statement that “all complaints, their outcomes, and all other documents pertaining to investigations…are restricted from release” and that “deliberations, a complaint, an investigation or a disciplinary proceeding…is not subject to release.” The Georgia Board of Examiners of Licensed Dietitians (six of whose seven members are RDs) refused to release detailed meeting minutes or a recording of recent board meetings to us—even though ANH-USA was an agenda item at its December 2012 meeting! Georgia’s “Dietetics Practice Act” empowers the board to “enforce the provisions” of the Act—one of which is that only a “person licensed…shall be engaged in dietetic practice.” That means that only an RD can legally “assess nutritional needs or individuals” or “provide nutrition counseling.” Although the board states on its website that “the Board has not issued Voluntary Cease and Desist Orders for unlicensed practice,” the minutes of the board’s August 24, 2012, meeting tell a different story: the board “moved to accept the Cease and Desist order, notify the Composite Board of Professional Counselors, Social Workers and Marriage and Family Therapists of the complaint, and close the case.” Why is this information buried in meeting notes, but not posted in the Cease and Desist section of the board’s website? At its June 15, 2012, meeting, the board went into executive session—that is, all matters were off the record and visitors were not privy to the discussion—to deal with “enforcement matters, investigative reports, and pending cases.” The board “moved to schedule an investigative interview” with a holistic health coach. As we reported last November, the Georgia board conducts undercover sting operation investigations with the full knowledge and cooperation of the Georgia attorney general’s office. We find it appalling that a government board, through a controversial dietetics law, is able to investigate and prosecute, has little to no accountability or transparency, and misinforms the public as to their actions. They’re not even required to tell you what was said when you or your organization is “reviewed and discussed” in their board meeting! North Carolina Most of our readers will be familiar with the story of Steve Cooksey, the health blogger that provided nutrition advice online. What you may not realize is that the Cooksey is one of nearly fifty people in North Carolina who have been targeted and investigated by the North Carolina Board of Dietetics/Nutrition over the past five years for possible violations of the state’s dietetics practice law. Our freedom of information request found that RDs in the state are posing as patients and consumers in order entrap individuals practicing nutrition without a license. We found a litany of needless investigations into practitioners who are not even violating the North Carolina dietetics law—though the board pursued these individuals simply because complaints were filed. We view this as tantamount to harassment. Do restrictive dietetics laws limit competition in the nutrition field? You bet. Consider the case of Liz Lipski, an expert nutritionist who was forced to leave North Carolina because the board denied her the right to practice as a nutritionist in the state. There are only 2,408 licensed dietitians in North Carolina to service a population of nearly 10 million people! By comparison, there are 119,069 registered nurses in NC. Media inquires please contact: Darrell Rogers 202-803-5123 darrell@anh-usa.org Action Alerts! While ANH-USA has been very successful defeating AND-proposed RD monopoly bills, we’re currently exploring multiple legal and regulatory options that would end the anti-competitive, restrictive trade and anti-free speech actions of state dietetics boards. If you are a resident of Florida, Ohio, Georgia, or North Carolina, please contact your state legislators and ask them to repeal your state’s dietetics board. In NC, there’s even a bill, HB 676, which hopes to do just that. Please send your message to your state senators and representatives today!

Florida	Ohio	Georgia	North Carolina

New York, S.4999, would create a licensure scheme for nutritionists and dietitians (lumping them together as if there were no difference). It creates a board disproportionately made up of RDs, ensuring a board biased against non-dietitians. This bill is very similar to one introduced last year by the same senator, Kenneth Lavalle (R-NY01). We hope the bill doesn’t have legs, since no companion House bill was introduced, and the similar bill did not go anywhere last year, but we’re not taking any chances. New York residents, please send your message immediately!

New York

Michigan, HB. 4688, would repeal the 2006 the Dietetic/Nutrition Regulation Act, and eliminate the Dietetic/Nutrition Licensing Board. Michigan residents, please send you message immediately!

Michigan

New Draft of Compounding Pharmacy Bill Just Released—Some Wins, but Concerns Remain

ANH-USA — Wed, 15 May 2013 21:18:16 +0000

We didn’t send our newsletter last night so we could bring you the absolute latest information from Capitol Hill. Action Alert! Last week we told you about draft legislation from the Senate Committee on Health, Education, Labor, and Pensions (HELP) that we believed would limit access to compounded medications. ANH-USA had a number of concerns regarding the first iteration of the bill, specifically the proposed requirements that would require doctors to indicate on a prescription why compounded medications were being used. We saw this as unnecessary regulation of the practice of medicine. Additionally, we were concerned about the bill’s language that would allow FDA to disallow entire categories of drugs that could be compounded, such as “extended release products.” The good news is that this time, some powerful senators are listening to grassroots activists like you. Your large-scale response to last week’s Action Alert made a real difference. ANH-USA has been talking to members of Congress on this issue, particularly Sen. Tom Harkin (D-IA), who is a real champion of natural health. We are the only natural health / grassroots advocacy voice at these meetings. The important thing to remember is that the HELP Committee and Sen. Harkin are still working on the bill, so it’s far from a done deal in the Senate. The second draft of the Senate bill was made public this afternoon. Some of our concerns were addressed, while others remain. For example, the first draft of the bill would have required a physician’s prescription “indicating that the compounded variation produces for that patient a significant difference.” We believe that is an intrusion into the practice of medicine, and through your emails and our efforts on Capitol Hill, this language was removed from the second draft. In addition, language has been removed that would have required RCTs (random-controlled trials, which are generally only required for patented FDA-approved drugs) for compounded medications. Compounding is by definition individualized medicine, so this clause ran the risk that each new variation would need to prove efficacy. Time-released thyroid is different, as is a smaller dose of a drug, or one with different binders. But because these medicines are of little economic benefit and given to relatively few people, an RCT requirement could effectively eliminate all compounded forms. We brought the issue to their attention, and that clause was eliminated! A few concerns remain, however. The current version of the bill still allows the FDA to disallow entire categories of compounded drugs in “complex dosage forms” such as extended release products or transdermal patches. The new language requires that these “complex forms” be “demonstrably difficult to compound,” apparently under the theory that compounds which are more difficult to create are somehow less safe. Our view is that there has to be demonstrable harm in the compounded medicine for it to be eligible for banning, not simply complex or difficult to make. Under current law, estriol (the bioidentical hormone) has a USP-NF monograph, so it can therefore be compounded. The revised bill would allow FDA to identify “drugs not suitable for compounding” even though they have a monograph as estriol does! This is a big concern for us. A third draft of the bill is expected to be circulated on May 20, with committee hearings and a vote on May 22. We have received word that the House of Representatives is also working on a pharmacy compounding bill. This may not be as bad as it sounds. Last fall Republicans on the House Energy and Commerce Committee blamed the FDA—not compounding pharmacies—for failing to crack down on the New England Compounding Center after its quality control problems last year, and told FDA Commissioner Margaret Hamburg that her agency already has all the authority it needs. Moreover, Rep. Fred Upton (R-MI), who chairs the House Committee on Energy and Commerce, has not put compounding on his list of legislative priorities for the year. Given the House’s skepticism about the FDA needing additional authority, we are hoping the bill will be different. We’ll keep everyone updated as it unfolds. Action Alert! We have revised last week’s message to Senate HELP Committee members to thank them for listening to our concerns, remind them of the areas that still need some work, and let them know that we’re eager to see a revised version of the draft bill. Even if you sent a message last week, please contact your senators again right away and make sure they understand that compounded medicine is a vital part of citizens’ healthcare needs, that the FDA has a history of targeting compounders, and all legislation should be approached with caution.

Don’t Empower the FDA to Take Away Your Access to Compounded Medications

ANH-USA — Tue, 07 May 2013 22:38:26 +0000

This new legislation is a wish list for Big Pharma. Action Alert! On April 26, the Senate Committee on Health, Education, Labor, and Pensions (HELP) released draft legislation that would “clarify” the FDA’s ability to regulate both compounding pharmacies and the compounded medications themselves. It's our understanding that the draft bill was written with the specific intent of giving the FDA broad authority to remove compounded medications from the market in one of two ways: either by putting bulk ingredients on a list of “banned” compounded drugs, or by redefining compounded variations of approved drugs as illegal “copies.” The way the bill is written, a compounded medication—like the low-cost pregnancy medicine 17P (similar to KV Pharmaceutical’s hugely expensive drug Makena), or a bioidentical estriol that can be used instead of Pfizer’s dangerous (and not bioidentical) Prempro—could be banned. We don’t yet know who is pushing the specific language of this bill, but it is interesting to note that Pfizer gave campaign contributions to eight out of the twenty-two members of the HELP Committee. There’s a silver lining, however: the bill will cost Medicare and Medicaid billions of dollars, because these programs rely on the more cost-effective compounded versions of these drugs, so there may be some serious push-back on it. It's possible that this bill would not only federalize compounded medications dispensed by prescription, but give the FDA authority over the state regulation of the practice of medicine! It would require that a practitioner certify on the prescription that the compounded variation produces “a significant difference from the marketed drug version.” Of course, the mere fact that the doctor is prescribing the medicine in the first place should be justification enough—the federal government should not interfere with the practice and prescription of medicine. The FDA already tries to meddle in the practice of medicine as we have pointed out before, and certainly does not need more authority to do so! The bill bans compounded drugs that are a “copy of a marketed drug,” but defines it so broadly that most compounded drugs could be removed from the market, thereby increasing healthcare costs and limiting patient access to important medications. For example, as we reported in 2011, KV Pharmaceutical considered compounded 17P to be a “copy” of their drug Makena and tried to ban its production. Fortunately, after pressure from Congress, grassroots activists, and the media, the FDA finally relented. Under this new bill, 17P could be banned. Millions of women depend on access to bioidentical hormones. Critical (complete) thyroid medications that millions of American women and men depend on would also be at risk. The bill would also ban certain veterinary medicines. Compounding pharmacies sometimes create a convenient, topical version of a marketed drug that is only available in oral form, for use on the many pets who don’t like taking pills. Even worse, the bill would give FDA the power to disallow entire categories of drugs that could be compounded, such as “extended release products.” Compounding pharmacies currently offer time-release, complete, desiccated thyroid compounds, which can be difficult to find elsewhere. Most thyroid medications made by drug companies are not complete, and some of these important thyroid medications are never available in time-release versions. The FDA has in the past attempted (unsuccessfully) to ban bulk bioidentical estriol at the request of a pharmaceutical company. With this bill, the ban would be much more likely. If the pharmaceutical industry were to come up with a wish list, we’d imagine banning compounded medicines would be at the very top. It seems clear that this legislation will be presented as a response to the problems at the New England Compounding Center we told you about last October. Poor quality controls at the facility led to some steroid injections becoming tainted with a fungus—an outbreak which FDA Commissioner Margaret Hamburg conceded last month was due to lack of FDA action despite many complaints they had received about the facility coupled with “a confusing legal landscape.” Hamburg asked for a consistent set of safety regulations that would require compounding pharmacies to report any problems associated with their drugs. Instead, it seems the bill does little to increase the safety of compounded medicines or improve facility inspections, but rather makes it easier for FDA to ban many compounded drugs altogether. Action Alert! If you are a resident of Alaska, Connecticut, Colorado, Georgia, Illinois, Iowa, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, North Carolina, Pennsylvania, Rhode Island, South Carolina, Tennessee, Utah, Vermont, Washington, Wisconsin, or Wyoming, please contact your member of the Senate HELP Committee and ask him or her to strike the extreme language in this bill that has nothing whatsoever to do with safety. Please take action immediately!

Gastric Bypass Surgery for Everyone!

ANH-USA — Tue, 07 May 2013 21:19:51 +0000

New recommendations from doctors take us even further in the wrong direction. Action Alert. Three medical societies—the American Association of Clinical Endocrinologists, the Obesity Society, and the American Society for Metabolic and Bariatric Surgery—jointly announced last month that they were changing their guidance on who should get metabolic and bariatric surgery, and which methods should be used. These new guidelines state that bariatric surgery should be expanded to include mildly to moderately obese people (class 1 obesity) who have diabetes or metabolic syndrome. Eligible patients would have a body mass index (BMI) of 30 or above; for a 5’9” adult, that’s a weight of 203 lbs. or higher—only 35 pounds over what is considered a healthy weight. This recommendation comes with a disclaimer: “Current evidence is limited by the number of subjects studied and lack of long term data demonstrating net benefit.” It is further noted that there is currently insufficient evidence for recommending a bariatric surgical procedure specifically for glycemic control alone, fat reduction alone, or cardiovascular disease risk reduction alone, independent of BMI criteria. In their press release, this statement is immediately followed up—with no irony whatsoever—with these words: “These clinical guidelines provide evidence-based recommendations and information to help surgeons, primary care doctors and other health professionals make the most informed decisions for the benefit of patients.” Evidence-based? How absurd! There’s no evidence at all for their recommendation, by their own admission! This is not the first time conventional medicine has recommended reducing the threshold for bariatric surgery. In 2011 we told you about an FDA panel’s recommendation that lap-band surgery be made available to 12 million more people than before. Gastric bypass surgery is not only a popular medical procedure; it is also an economic goldmine. Bariatric surgery has a 45% profit margin—larger than most procedures (by contrast, other money-making procedures like coronary artery bypass surgery have an estimated profit margin of only 30%). And it’s almost always covered by insurance. Bariatric surgery can reduce weight—at least at first. But weight loss does not necessarily result from reducing stomach size or primarily from that. New research suggests that the weight loss that occurs after gastric bypass surgery may be the result of changes to stomach flora. This study is discussed in the May 2013 issue of Dr. David Williams’s Alternatives newsletter. It has been known for some time that after surgery, the gut changes in its chemistry, not just its size—but it wasn’t clear whether the chemical changes were produced by the weight reduction, or caused it. This study found that the chemical changes were the catalyst to weight loss. The data isn’t conclusive for humans—the study used test animals—and much remains to be understood about the process involved. If chemical changes in the gut are what causes people to lose weight, not a change in stomach size, it is better by far to shift the gut bacteria using probiotics. Bariatric surgery is far from routine. Studies show that 1% of patients die from the surgery, and complications affect up to 40% of patients, including vomiting, diarrhea, infections, hernias and respiratory failure; as well nutritional deficiency, potentially resulting in anemia, osteoporosis, and bizarre neurological problems. Seizures and paralysis have even been reported in extreme cases. One thing to worry about in particular is damage to the vagus nerve, which controls many important digestive functions including bile release and the movement of food. Moreover, a study from the Journal of the American Medical Association shows that bariatric surgery does nothing to reduce a patient’s long-term health care expenses. On top of that, the surgery is considered a “success” if only 50% of one’s excess weight is lost—even though the patient would still be overweight or obese—and within ten years, as few as 20% of patients have maintained their weight loss. This may be because the chemical changes in the remaining gut do not persist—though they could be maintained with the right diet and supplements. Indeed, these ideal gut conditions could and should be created without the surgery in the first place. Weight loss supplements are a hot topic right now. Not surprisingly, the FDA is considering completely banning weight loss claims for anything other than drugs. So far, they have hesitated because there aren’t many weight loss drugs and they often have horrifying side effects. But if you haven’t taken action by writing the FDA to tell them not to ban supplement weight loss claims, please do so now. One supplement much discussed for weight loss now is Garcinia cambogia, an extract from the Malabar tamarind. Studies in the 1960s and ’70s showed that Garcinia cambogia contains hydroxycitirc acid (HCA), which inhibits the enzyme ATP citrate lyase, diverting the conversion of carbs from fat to energy production instead. Furthermore, fatty acids in the body’s “fat pool” continue to be released, contributing to overall fat loss. As Dr. Harry G. Preuss, MACN, CNS, a member of our board, points out in his paper “Garcinia Cambogia: How to Optimize Effects,” the quality of the Garcinia extract is important—it must contain a minimum of 50% HCA, and must not be composed wholly of calcium salts as this would decrease bioavailability. Potassium and/or magnesium should be present (both increase bioavailability), and a product with low lactone content is recommended. It must also be taken on an empty stomach (at least 30 to 60 minutes before a meal), because otherwise it will bind to components in the meal and be inactivated. (This is called the “food effect,” and it can reduce bioavailability of many different supplements besides HCA). Garcinia provides an object lesson in using supplements wisely. It is never as simple as just taking a pill. The formulation is important; the co-factors are important; and your individual body chemistry is important. Always consult a knowledgeable professional. Besides Garcinia cambogia, there are curcumin and cinnamon, which control blood sugar levels; magnesium, chromium, amino acids, and green tea, which help with weight loss; and Irvingia gabonesis supplements (derived from a wild mango from central and western Africa), which has showed impressive weight loss effects in a recent ten-week RCT. For more suggestions, including the importance of good fats, the right kind of exercise, and metabolic typing, see our earlier article, “Natural Solutions for Losing Weight.”

GMO Labeling Bill Introduced in Congress

ANH-USA — Tue, 30 Apr 2013 20:00:47 +0000

The bill has some teeth. The question is whether it has legs. Action Alerts! The Genetically Engineered Food Right-to-Know Act was introduced last Wednesday in both the Senate and the House of Representatives. The bill, sponsored by Sen. Barbara Boxer (D-CA) and Rep. Peter DeFazio (D-OR) with nine cosponsors in the Senate and twenty-two in the House, would require food manufacturers to clearly label any product that has been genetically engineered or contains genetically engineered ingredients, or else the product would be classified as “misbranded” by the FDA. Both Boxer and DeFazio have previously sponsored GMO labeling bills, but this is the first labeling bill that has both bicameral and bipartisan support (though the latter is decidedly modest: only one cosponsor in each chamber is a Republican, and both are from Alaska). The new labeling requirement does not apply to food used in restaurants, or in hospitals or other medical environments. Nor does it apply to food produced using a GE vaccine or a “processing aid” such as yeast. Food manufacturers are protected so long as they have a statement from the grower that the food contains no GMOs. The bill also protects producers whose food was unintentionally contaminated by GMOs, so long as the contamination did not occur as a result of negligence. Enforcement would be left up to the FDA rather than through civil action. Both Sen. Boxer and Rep. DeFazio note that the public has been pressuring the government to label GMOs. Sen. Boxer also listed some of the many businesses and organizations that support the GMO labeling bill—including ANH-USA. Although we are extremely pleased that the legislation has been introduced, at this stage it is unlikely to have enough support in the Senate (much less in the House) to pass. Only about five percent of either chamber has signed on as a cosponsor, and support from the Republicans on this bill is notably weak. On top of that, many elected officials are in bed with the biotech industry—which, it should go without saying, immediately pushed back against the bill. The very day the bill was introduced, representatives of Monsanto and the Biotechnology Industry Organization (BIO), a GM trade group, objected to the bill even while acknowledging they had not actually read it, saying that they oppose GMO labeling on general principle: “Advocates of mandatory GMO labeling are working an agenda to vilify biotechnology and scare consumers away from safe and healthful food products.” Once again Monsanto seems to be saying that it is so proud of its product that it doesn’t want consumers to know they are getting it. What this means is that your voice is even more important now. Our Action Alert (see below) is aimed at strengthening the bill’s chances, and the more pressure you can put on your legislators, the better. Our sort of grassroots activism is definitely starting to bear fruit—overt opposition from the food industry for a federal labeling standard is weakening, and may even have sparked some preemptive action on their part:

Some food companies recently met with the FDA to discuss GMO labeling in a meeting sponsored by the AGree Foundation;
Walmart announced that the company would no longer take a lead in opposing GMO labeling efforts; and
Whole Foods says that by 2018, all products sold in their stores throughout the US and Canada must be labeled if they contain GMOs.

As heartening as it is to see the food industry beginning to respond to the public’s calls for labeling, it’s extremely important that this also happen at the federal level, especially considering that GM salmon is on the verge of approval. As we reported earlier this year, the FDA released an environmental assessment on AquaBounty’s GM salmon that concluded that the fish would have “no significant” environmental impact—thus pushing “Frankenfish” one step closer to approval. If this happens, it will create a dangerous precedent—in essence, a regulatory approval pathway—for other genetically engineered animals which the biotech industry has waiting on the sidelines. At the state level, over 65 bills concerning GMOs have been introduced so far in 2013, the majority of them about labeling. None so far has been enacted into law; thirteen of them have been defeated. A few, though, have positive momentum:

Alaska already has a law requiring labeling of GMO shellfish and fish, and on March 25 the legislature unanimously approved resolution HJR 5, opposing a petition by AquaBounty Technologies to commercialize GM salmon.
Connecticut: Two GMO labeling bills (HB 6519 and HB 6527) passed out of committee by an overwhelming majority. Supporters have until June 5 to get the full legislature to pass them.
Maine: LD 718 has more than 120 bipartisan cosponsors. Maine’s legislative session ends on June 13.
Vermont: H 112 has over 50 sponsors and the support of Gov. Shumlin (despite opposing the bill last year after Monsanto threatened to sue the state if a GMO-labeling bill passed). The bill has already passed the House Ag Committee.
Washington: After an extensive grassroots campaign, ballot initiative I-522 was able to gather 353,331 valid signatures. The initiative will be on the ballot in November 2013.

These various GMO labeling initiatives are especially important in light of a recent report that links glyphosate—the pesticide Roundup, for which the genetically engineered Roundup Ready crops were created so that more and more of the pesticide could be used without damaging the plant—to a wide range of health problems and diseases, including Parkinson’s, infertility, and various cancers. There’s a family of fifty different enzymes collectively known as Cytochrome P450, which are the detoxification heavy hitters in the human body. According to the report, glyphosate destroys the CYP450 detoxification pathways. Not only is the expanded use of Roundup increasing our exposure to this toxic herbicide; it’s also reducing the body’s ability to detoxify many xenobiotics. It’s a potentially very dangerous double whammy. When the CYP450 pathways are destroyed, it results in altered gut bacteria and ultimately all the western-related, chronic diseases such as diabetes. If the plants were not genetically altered to withstand such high concentrations of the pesticide, we wouldn’t be exposed to such toxic and health-destroying levels. Action Alert! Please contact your senators and your representative and tell them to support the Boxer–DeFazio bills.

And if you are a resident of Connecticut, Maine, or Vermont, send a message to your legislators in support of the GMO labeling bills pending in your state. Connecticut Action Alert! Maine Action Alert! Vermont Action Alert!

Can Homeopathy Be Both a Useless Placebo and Dangerous at the Same Time?

ANH-USA — Tue, 30 Apr 2013 19:00:00 +0000

Let’s look at the science. Earlier this month we told you about an attack on homeopathic medicines in California courts, one that could threaten the industry. We also told you about a recent report published in the International Journal of Clinical Practice. That report claimed to do a systematic review of all adverse event reports (AERs) in connection with homeopathy from 1978 to 2010. On the one hand, the report concluded that homeopathy is ineffective because it has no active ingredients, that it is nothing more than a placebo because it has been diluted so much that “the likelihood of a single molecule approaches zero.” On the other hand, the report also concluded that homeopathic preparations caused many dangerous allergic reactions. We pointed out that you can’t have it both ways—either homeopathic preparations are powerful enough to cause a physiological reaction, or they can’t do anything at all. This is all too typical of what passes for scientific review of homeopathy. Dismiss it any way you can, regardless of fact or logic. If that doesn’t work, then argue that homeopathy is dangerous because it may keep people from visiting a conventional doctor. We promised to return to the subject of what real evidence there is behind homeopathy. That is a large subject, but here are some scientific studies from the past ten years showing that homeopathy can indeed be effective—far more effective than placebo. These studies, which range from random controlled trials (RCTs, the supposed “gold standard”) to observational studies to meta-analyses, often look at homeopathy as an adjunct to conventional medicine. Here is just a sampling:

Acute otitis media (when the middle ear gets blocked with fluid and infected with bacteria): a 2012 RCT showed that symptomatic improvement was quicker in the homeopathy group than conventional therapy group, with a much lower antibiotic requirement
Allergies: a 2012 observational study revealed that homeopathy substantially improved allergy symptoms and conventional medicine dosage could be substantially reduced; a 2013 study listed the effectiveness of different homeopathic treatments for allergies based on the type of allergy
Asthma: In a study of individualized homeopathic treatment for asthma, there was evidence that it decreased the severity of asthma in children

Other studies show effectiveness of homeopathy for conditions ranging from chicken pox, diarrhea, and in a multi-center observational study, chronic sinusitis. Homeopathy could be an effective treatment for low-grade chronic inflammation, which is the root of many diseases, and as a complement to conventional anti-tubercular treatment (a finding that is especially important as patients are becoming resistant to TB drugs). Much more research is ongoing despite the abysmal lack of funding for it. At the very least there is promising evidence supporting homeopathy. So if it works, how does it work? A homeopathic remedy is an extremely pure, natural substance that has been diluted many times. In large quantities these substances would cause the same symptoms the patient is trying to cure. In tiny, diluted doses, it is not only safe and free from side effects, but it will trigger the body to heal itself. For example, when you chop a red onion, it causes watery eyes and a runny nose in most people. Allium cepa is a remedy created from red onion; in very small doses, Allium cepa doesn’t create those symptoms but instead activates the body’s own mechanism for stopping watery eyes and a runny nose. As noted in “Immunology and Homeopathy,” an article published in the journal Evidence-Based Complementary and Alternative Medicine, “The profound analogies between homeopathic thought and immunology are due to the fact that the whole of homeopathic theory is substantially based on the principle of regulating endogenous systems of healing, the best known of which is certainly the immune system and its neuroendocrine integrations.” Around the end of the 19th century, scientists observed that different doses of the same substance can create wildly varying effects in humans. They observed that weak stimuli slightly increase biological responses, medium stimuli markedly raise them, strong ones suppress them, and very strong ones arrest them. This principal, called hormesis, is seen, for example, in medicinal plants: belladonna, in very small doses, has long been used as a pain reliever, muscle relaxer, and anti-inflammatory; in large doses it is extremely toxic. Foxglove (digitalis) helps cardiac arrhythmias in minute dosages, but in large doses can cause heart block and either bradycardia (decreased heart rate) or tachycardia (increased heart rate), depending on the dose and the condition of one’s heart. The big difference between these practices and homeopathy is the amount of dilution used—and it is here that conventional medicine has such difficulty with it. In homeopathy, the substance (an herb, mineral, or animal product) is crushed and dissolved in a liquid (usually an alcohol and water solution), violently shaken with impact at least 100 times (“succussion,” usually done mechanically), then stored. This is the “mother tincture.” Homeopaths then dilute tinctures further. One part of the tincture to ten parts of the liquid is a 1X dilution (X being the Roman numeral for ten), with another round of succussion. A 2X potency takes one part of the 1X potency and adds it to nine parts of the diluting solution, thus creating a one-to-100 dilution; common potencies used in homeopathic remedies usually begin around 6X, or one part of the original mother tincture to one million parts of the diluting material. By the time you get to a 30X dilution, there is no measurable part of the original substance left. The precise mechanism of how homeopathy works—why greater and greater dilutions should have more and more power, and why the violent shaking with impact should be so important—is still unknown. This is not really surprising given the lack of funding available to study the question, although some prominent scientists such as Luc Montagnier, the first discoverer of the AIDS virus, is pursuing it. Despite the lack of formal research funding, homeopathy has always been an observational science, testing and refining a practice until it works better and better. The authors of “Immunology and Homeopathy” (cited above) put it this way: “The two approaches to system regulation—scientific/reductionistic and homeopathic/holistic—are not conflicting, but use different approaches: mainstream pharmacology applies a ‘structural’ analog, which is identified as the molecule binding to specific receptors or enzymes of the target system (if known). Classic homeopathy applies a ‘functional’ analogue, which is identified as the diluted compound that is able to regulate and/or to trigger homeodynamic systems. This kind of functional analogy, based on the similarity of symptoms, can be exploited even if the details of the receptors or the effector enzymes are unknown within the complex homeodynamic networks.” Conventional medicine is, by and large, solely focused on biochemistry. but living cells and tissues also generate bioelectromagnetic fields, and it is at this level that homeopathy may be working. Every electron in every cell vibrates; so if everything vibrates, it would seem fairly logical that one vibration must affect another. One current hypothesis is that the succussion of the dilution strengthens the vibratory resonance of the substance, even when the physical component of the substance has been removed. Other hypotheses discuss homeopathy in terms of nanotechnology—or nanopharmacology. The micro-bubbles and the nano-bubbles caused by the succussion may produce microenvironments of higher temperature and pressure. Several studies by chemists and physicists have revealed an increased release of heat from water in which homeopathic medicines are prepared, even when the repeated process of dilutions should suggest that there are no molecules remaining of the original medicinal substance. In other words, no one knows precisely how homeopathy works. That is the rub. But there is a vast amount of anecdotal evidence that it does, including the experiences of ANH staff, such as an instant cure of trigeminal neuralgia, one of the most painful and difficult conditions to heal, instant cures of infant earaches, teenage allergies, and much more. Scientific studies, undertaken with very little funding because these are not patentable drugs, are now starting to show that it does work—and that it is far safer than FDA-approved drugs. In the meantime, vicious attacks on homeopathy—in the US and UK and elsewhere—continue, both because it is an affront to conventional medical thought and an economic threat to the patent drug business.

Hyped Supplement Tests Reveal Questionable Methods and Motivations

ANH-USA — Tue, 23 Apr 2013 21:00:40 +0000

Dr. Oz needs to dig a little deeper into this organization. Here are a few things we said about ConsumerLab in an earlier report:

One of the most prominent [supplement] testing laboratories does not appear to us to be either independent or impartial.

ConsumerLab.com says its stated mission is “To identify the best quality health and nutritional products through independent testing.” Unfortunately, their claim to independence does not appear to us to be valid.

ConsumerLab.com (CL) approaches dietary supplement makers and asks them to enroll in its “voluntary” testing program—for a fee. CL doesn’t publicly disclose its fee schedule, but we know that one company was charged over $4,000 to test a single product. Companies that pay the fee are guaranteed that if one of their products passes the testing under their Voluntary Certification Program, it gets listed on the site and may carry the CL Seal of Approval—and if it fails the testing, the product will never be identified publicly because the results are “proprietary to the manufacturer”!

However, companies that do not agree to pay for the voluntary certification program risk having their products tested anyway through the firm’s “product review program.” If they fail the test, those failures will be publicized on ConsumerLab.com’s website and in the media, with complete details for sale in CL’s Product Review Technical Reports.

This arrangement strikes us as nothing short of scandalous. It sounds like, “Pay up, and you won’t have to worry about the results. Don’t pay up, and you may be exposed to bad publicity.” What kind of game is this?

You might guess from the name “ConsumerLab” that the company was an actual testing facility. But CL actually farms out its product testing. Although the company admits it’s a “third party group” certifying the quality of dietary supplements, CL does not identify the laboratories it uses. Does the company do an annual audit of the labs it uses to make sure they are following Good Laboratory Practices and otherwise operating up to standard? We don’t know, and they’re not saying. Despite all this, CL is often quoted by mainstream media as being experts on supplement safety and testing.

In its latest report, CL tested forty-two of the leading multivitamin/multimineral products sold in the US and Canada (including three multis intended for pets). They “failed” sixteen products—some for the most specious of reasons. For example, CL tested how long it took for a product to disintegrate in water, claiming that it is indicative of whether it can be absorbed in the body fast enough. Products taking longer than thirty minutes to dissolve received a failing grade. The stomach, of course, does not digest in water—and the process takes a lot longer than thirty minutes. The FDA has established what are called Current Good Manufacturing Practices (cGMPs). The cGMPs require companies to set specifications for all aspects of its products, including disintegration. One supplement company, NOW Foods, established its own disintegration time of sixty minutes for relevant products, and this met with FDA’s approval. CL’s thirty minute disintegration time isn’t an arbitrary number, however: it’s based on a drug standard. This is absolutely not appropriate for supplements, because supplements are digested as foods. CL also warned against products for exceeding the upper limits (UL) for nutrients set by the Institute of Medicine, whom we have taken to task for their disastrously low recommendation for vitamin D dosages. As Dr. Robert Verkerk, scientific and executive director for ANH-Europe, points out in the journal Toxicology, ULs are intrinsically flawed, as they focus on a single, most sensitive adverse effect on the most vulnerable sub-population. “Paradoxically,” he writes, “dosages that induce risks in sensitive populations commonly overlap with those which induce benefits in the majority.” The result is dietary supplement dosages that are so weak as to be ineffectual in the majority of the population. One of the ULs that CL tests for is niacin. As Verkerk notes, “Given that ULs for niacin have been set at 10 and 35mg/d by the Scientific Committee on Food / European Food Safety Authority (EU) and the Institute of Medicine (USA), respectively, it is noteworthy that most of the benefits, such as blood lipid management, occur substantially above these dosages.” Further, he notes that different levels may be reached depending on the form of niacin. CL “failed” one product for not meeting what CL claimed was the folic acid level claimed on the label, even though the product actually contained not folic acid but natural folates. The method for testing for natural folates (which is the method recommended by the Association of Analytical Communities) is very different from the folic acid test (which is the US Pharmacopeial Convention method). After contacting CL, they claimed to have tested the product using both methods. We’ll just have to take their word on that. CL also singles out companies that were just within the UL for certain nutrients. If they are within range, why even mention these companies at all? The simple “approve” or “fail” method for grading multivitamins can itself be misleading. Some supplements may “fail” on very debatable grounds, such as UL or some technicality, while others might have far more serious problems. Lumping them together appears to serve no purpose other than to encourage more companies to buy CL “services.” As usual, CL’s report does not discuss the methodology they used—how many times they tested a product, what lab was used, etc. Laboratories can be very unreliable, and repeat testing may be necessary. How can they expect anyone to take them seriously while withholding this information? On a recent TV show, Dr. Mehmet Oz discussed the report—and frankly hyped it—while at the same time giving viewers further misleading information. For example, Dr. Oz claims that FDA doesn’t monitor supplements as they do drugs. That is simply not true. Both have Adverse Event Reporting systems. Both have to follow cGMPs—whether the product is pure, lives up to the information on its label, etc.—which is what CL is essentially testing for. The show implied that many supplements are contaminated with heavy metals such as lead, with serious health effects. In reality, only one product had any lead contamination at all, at levels that weren’t very high—and it should have been mentioned that it was one of the products marketed for pets. Dr. Oz claimed that “many” products failed in the aforementioned disintegration test, when in fact only two of them did, and as we have pointed out above, it isn’t the right test. Supplement safety is an important topic. We don’t have all the answers on this complicated subject, although there is evidence that supplements are the safest part of the food chain. One of the problems is that the highest quality supplements, with the most carefully sourced ingredients and the most checking, often cost more, and many consumers simply cannot afford the extra cost. We urge consumers to educate themselves as much as possible in order to make an informed choice and we hope to provide more information for you on this important subject in the future. In the meantime, check out our guidelines for making sure your nutritional supplements are of the highest quality.

Your Tax Dollars May Buy 400,000 Tons of Sugar to Keep Prices Artificially High

ANH-USA — Tue, 23 Apr 2013 20:00:57 +0000

Welcome to the government sugar/industrial/drug complex. Sugar—in all its forms—is considered the primary cause of type 2 diabetes. It also suppresses the immune system, is linked to cancer, and leads to cognitive problems, as we reported last year. Government subsidies, taking a great variety of forms, are increasing rather than decreasing. Diabetes drug sales are now $35 billion with other related illness sales even higher. Let’s see how all this connects. The US is the world’s largest sugar producer. We produce an average of 8.1 million tons of granulated sugar every year. Since the mid-1990s, sugarcane has accounted for 45% of the sugar produced domestically, with sugar beets providing about 55%. By 2010, genetically engineered varieties accounted for about 95% of sugar beets, up from 60% in 2008. High-fructose corn syrup (HFCS) is derived from the milling of corn. Production of HFCS increased from 2.2 million tons in the 1980s to an average of 9.2 million tons during the 2000s. In general, deliveries of sugar (raw cane sugar and sugar beets) and other sweeteners (corn sweeteners, honey, maple syrup, and edible syrups, excluding no caloric sweeteners) averaged about 21 million tons during the 2000s. The US Department of Agriculture makes loans every year to processors of domestically grown sugarcane and sugar beets as part of the 2008 Sugar Act. HFCS processors, on the other hand, benefit from corn subsidies (also reinforced in the 2008 Farm Bill). Last October, sugar processors (both beet and sugarcane) borrowed $862 million under the price support program—loans secured with some 4.1 billion pounds, or 2.05 million tons, of sugar that companies expect to produce from the current harvest. The loans did little to keep sugar prices high, however: they have fallen 18% since October. According to a Tufts study, one reason may be that the elevated price of raw sugar and sugar beets enable HFCS processors to undercut sugar producers with their cheaper product, thus making the sugar worth less. Sugar processors are afraid they’ll have to default on their loans, which could result in $80 million in losses to the USDA’s price support program. USDA is considering helping them out once again—this time by buying 400,000 tons of sugar, just so they can pay back their loan! Keeping sugar prices up of course means that consumers spend more. According to a study commissioned by the Sweetener Users Association, the program costs consumers $2.9 billion to $3.5 billion annually. A bipartisan group of senators wrote an article for the Capitol Hill newspaper The Hill in which they said that by controlling the sugar supply, our government is boosting prices and those higher prices cost the country 20,000 jobs each year. Of course, part of USDA’s excuse for rubberstamping GMO sugar beets was that the economy depended on sugar production. Hmm? Why is this happening? Why is the government gouging consumers and encouraging an industry which contributes to so much illness? Sugar makes up only 1.9% of the total value of all US crops, but the sugar industry accounts for 33% of crop-related lobbying dollars. They also give 55% of crop-related PAC donations—more than all other US crops combined. An intensive public relations campaign that started in the early 1970s was able to sweeten public opinion about sugar in a major way. The industry bankrolled scientific research. Each research proposal was overseen by a panel of industry-friendly scientists plus a committee of representatives from sugar companies and “contributing research members” such as Coca-Cola, Hershey's, General Mills, and Nabisco. Unsurprisingly, each of the studies they funded seemed to point to sugar’s safety. No independent research showing how dangerous sugar is was considered for funding. Big Sugar even contributed to supportive FDA and USDA rulings on sugar: leading the panel that evaluated sugar for the FDA was a former chair of the scientific advisory board for the International Sugar Research Foundation. By now the cover-up has frayed. Everyone knows that sugar is a health risk. You may recall our article in which we reported that type 2 diabetes has increased by 90% in the past decade. A new study, published in the peer-reviewed online journal PLOS One, finds a direct correlation between sugar and diabetes—a correlation that is independent of other factors such as obesity, aging, exercise, or tobacco and alcohol use. The study concludes that “Duration and degree of sugar exposure correlated significantly with diabetes prevalence in a dose-dependent manner, while declines in sugar exposure correlated with significant subsequent declines in diabetes rates independently of other socioeconomic, dietary and obesity prevalence changes.” In plain English, they found that the more sugar you consume and the longer you consume it, the higher your diabetes risk; and as sugar consumption drops, diabetes rates drop as well. The CDC says there will be nearly 140 million diabetics in this country within the next forty years. Diabetes drugs are big business—they bring in $35 billion now, but are poised to jump to $58 billion by 2018. Think about that. If diabetes drugs make so much money, the pharmaceutical industry has a reason not to try to cure the disease. Meanwhile your government is supporting both the sugar industry and the drug companies. And not only are the drug companies—like the sugar producers—big campaign donors. They are also providing much of the funding of the US Food and Drug Administration. The link between chronic diseases of all kinds, government policies and subsidies, and drug profits is not a pretty one. But knowing what is going on is the first step toward cleaning up the system.

Latest “Red Meat Study” Doubly Flawed

ANH-USA — Tue, 16 Apr 2013 19:00:51 +0000

No, meat is not unsafe—nor is L-carnitine. A recent study published in the journal Nature Medicine associates the amino acid L-carnitine, found in red meat, supplements, and sports supplements, with the risk of heart disease. Here are some examples of what the media said about it: The Daily Mail (UK): “Red meat nutrient used in weight-loss and muscle-building supplements could cause heart disease”! The Dallas News: “Put down that steak! (and energy drinks, too); the carnitine in these foods may increase risk of cardiovascular disease”! Here is the gist of the study:

a diet high in L-carnitine promotes the growth of certain bacteria that metabolize the amino acid;
during that metabolization, an organic compound called trimethylamine-N-oxide (TMAO) is produced in the blood; and
this compound increases risk of heart disease.

The study further states that vegetarians and vegans have different gut bacteria, which do not produce a burst of TMAO after consuming L-carnitine. There is a lot to find fault with in this study. First, there’s the question of the study participants. Most of the study was done on mice, though there was a human component—a tiny sample of only six people, five meat-eaters and one vegan. That’s right, their conclusion that vegetarians and vegans have different gut bacteria that don’t produce a burst of TMAO after consuming L-carnitine was based on just one individual. We also don’t know how healthy the five meat-eaters were in this study. The study found that the red meat eaters did not produce TMAO after a course of antibiotics. This suggests that these subjects’ immune systems were already damaged—not that all meat eaters’ are. At the same time, it is still unclear whether TMAO production is caused by eating red meat at all (this was just an assumption), and whether raised TMAO levels actually cause heart disease. Second, the idea that L-carnitine causes heart disease conflicts with other, better evidence. A large and recent meta-analysis, published in the journal Mayo Clinic Proceedings, suggests that L-carnitine is helpful for heart disease, not a cause. This meta-analysis specifically tested L-carnitine on hard outcomes in humans who had already experienced acute myocardial infarction, and found that L-carnitine was associated with significant reduction in death from all causes and a highly significant reduction in ventricular arrhythmias and anginal attacks following a heart attack, compared with placebo or control. In other words, L-carnitine, far from being harmful to the heart, actually heals it! None of the media reports we saw bothered to mention any of the positive effects of L-carnitine—even those mentioned in the study itself. Its essential function is to transport fatty acids into our mitochondria, which may be why it is so beneficial to heart patients. It also helps with kidney disease and male infertility, reduces fat mass, increases muscle mass, and reduces fatigue. In elderly patients, it also helps energy metabolism and improves neurotransmitter function in the brain. And if L-carnitine is actually good for us, what about meat? That’s still controversial. But other studies don’t support the conclusion that it harms us. An extremely large meta-analysis published by Circulation (over 1.2 million participants) found that fresh and unprocessed red meat consumption was not associated with increased heart disease risk, stroke, or diabetes. In addition, this one, much-hyped study makes no differentiation between different types or sources of meat. As we have discussed frequently in the past, industrialized factory farm meat is very different from organic, local, grass-fed meat in its nutrient composition. Meat from CAFOs—that is, confined animal feeding operations—contains twenty times the amount of omega-6 fatty acids (which are associated with inflammation, arthritis, and cancer) than healthier omega-3 fatty acids, have much more fat marbling, and may be full of antibiotics. Grass-fed beef has nearly seven times more omega-3s than omega-6s, so eaten in moderation, it offers healthier levels of essential fats. Moreover, grass-fed beef is lower in total fat, and higher in vitamin E complex, beta-carotene, thiamin, riboflavin, calcium, magnesium, potassium, and CLA—and these differences may have a tremendous impact on both the types of bacteria in the gut and the levels of TMAO produced. But of course, we won’t know about that, because this was never even thought about in the study. What none of these overhyped media reports—not to mention the study itself— take into account is the reality of bioindividuality. No one diet, and no one selection of supplements, should be advocated for everyone. Only a balanced diet tailored to each individual body’s personal needs will ensure one’s health in the long run.

Healthful Artisanal Cheese Under Attack Again

ANH-USA — Tue, 16 Apr 2013 18:00:38 +0000

FDA simply ignores the lack of a single documented illness in twenty-three years. Action Alert! Cheese, particularly real cheese, gets a bad rap. The American Heart Association makes “heart-healthy suggestions” to eat cheese with five or fewer grams of fat per ounce, and light or fat-free cheese products. The American Diabetes Association recommends low-fat cheese recipes—even though they usually contain more sugar! And the Physicians Committee for Responsible Medicine put up a series of billboards showing fat folks with the captions “Your Abs on Cheese” and “Your Thighs on Cheese.” This is all nonsense. Cheese is actually good for you— especially when it’s made correctly, as is done in Europe by introducing bacteria at the right time and following a careful process. Artisanal cheese is hand-made from milk that comes from a single source (local whenever possible), and its creation focuses on the quality of its raw ingredients and the health of its animals. People are generally willing to pay higher prices because of its superior taste and health benefits. Cheese is the best source of vitamin K2, which the body needs (together with vitamin D) to process calcium correctly. Unfortunately, artisanal cheese is not widely available in the US. There are some raw-milk artisanal cheese producers in some states, though not many. Several years ago, the FDA shut down the importation of most fine cheeses from Europe. Only a few larger companies—mainly offering pasteurized cheeses—are still allowed to import to the US, though as Cathy Goldsmith of Berkeley’s Cheese Board Collective points out, “The pasteurized versions are just not very good. They don't ripen in the same way. They get flat and bitter as opposed to gooey and rich and multilayered in flavor,” and sales of pasteurized imported cheeses have dropped. Of course, the industrialized, pasteurized, often tasteless cheeses are not only protected from competition; they also get tremendous economic support directly from the government. The government buys it and distributes much of it to school lunches where it is used mainly in pizza. You know, the same pizza which for the government counts as a vegetable because it has some tomato sauce. The USDA even has a marketing arm called Dairy Management that actively pushes the sale of cheese and milk. How did we get so obsessed with pasteurization anyway? After World War II, retail milk’s competition was based on how much cream your milk had—the more the better—which was clearly visible because of “the cream line.” But this made the cheaper, less rich milk harder to sell. So the dairy industry started homogenizing the milk to do away with the cream line. That catch is that once milk is homogenized, if there is no further processing, it will go rancid in a matter of hours, which didn’t happen as quickly when milk was kept in its natural state. So pasteurization was mandated, first by states and then federally. The FDA wants simple solutions and does not want to be blamed for food poisoning. So it likes large scale industrial solutions like pasteurization, especially ultra-pasteurization, and food irradiation (“nuking”). It has been alarmed about listeria in cheese for some time. The initial charge, and especially the attack on French cheese, came at the same time the French were refusing to support the invasion of Iraq. That is when French raw cheese was first banned and then only a few large producers were allowed to send it here. Now the FDA, in conjunction with Health Canada, has just issued a joint risk assessment that claims consumers are “up to 160 times more likely” to contract a listeria infection from soft-ripened cheese made from raw milk compared to the same cheese made with pasteurized milk. Listeria monocytogenes has some of the highest fatality and hospitalization rates among pathogenic bacteria. In the US, the FDA estimates that there is one case of listeriosis linked to raw-milk cheese for every 55 million servings eaten. Except that this estimate is not based on any direct evidence—it’s a mathematical probability only. The report is actually saying that if 55 million people eat raw-milk cheese (and with as little raw-milk cheese as is being sold in this country, the idea that 55 million of us are eating unpasteurized cheese is patently absurd), it is a mathematical probability that one lone individual will get sick from it. In fact, it’s the lack of damning evidence that is so striking. Between 1986 and 2008, the report could not account for one single documented illness in the US from listeriosis due to tainted brie or camembert (soft cheeses). The researchers were only able to document twenty occurrences of illness from listeria in all cheeses from all kinds of milk worldwide over the same twenty-three-year period—less than one per year—and, according to the report, half of these illnesses involved cheese made from pasteurized milk! Compare that to the frequency of other foodborne illnesses (more than 1,000 outbreaks, resulting in between 15,000 and 30,000 illnesses, from all foods each year in the US), and raw cheese has a demonstrably sterling record of safety. Listeria usually comes from the cheese-making environment, not from the milk itself. The few problems that have occurred were almost all from unlicensed producers. On page 17 of the report, they show four outbreaks of listeriosis from soft cheese—but all four were from homemade raw milk queso fresco (nicknamed “bathtub cheese”) which was not aged the required 60 days. In other words, the only incidents have been from cheese that was already illegal in the US. While the FDA has a zero tolerance policy for listeria, which effectively crushes raw dairy production, Europe takes a different approach. They have tolerance limits with strict quality control measures in place. The FDA is making its draft risk assessment available for public comment. The Weston A. Price Foundation, in its formal comments to the FDA, recommends that FDA rules on dairy take into account processes for raw cheese making, and that it should be sensitive to the size and scale of the operation. Unfortunately this runs contrary to everything the FDA seems to believe in. Of course, cheese is not the only story here. Weston Price as a good deal to say about the health value of real butter—butter made from raw milk—which is naturally high in vitamin A, supports the immune system, is good for preventing arthritis and osteoporosis, and helps the thyroid gland and the gastrointestinal system. Butter generally sells for hardly more than cream, even though it is made from cream and takes a good deal more work to produce—which means there’s no price incentive for artisans to produce raw milk butters. Producers are further discouraged from making raw butter because the FDA makes it so difficult for them. Action Alert! There are bills pending in three states—Hawaii, Indiana, and Massachusetts—that deal with the sale of raw milk and milk products directly to the consumer. Please contact your state legislators and let them know you support raw milk and artisanal cheeses and butters! Hawaii Action Alert! Indiana Action Alert! Massachusetts Action Alert!

Homeopathy Under Attack in California

ANH-USA — Tue, 09 Apr 2013 22:00:16 +0000

Because homeopathic medicines are protected at the federal level, the attempt to eliminate them is coming at the state level. Homeopathic medicines are protected as legal drugs under the Food, Drug, and Cosmetic Act (FD&C)—which means homeopathic manufacturers can make disease claims. We can thank a brave legislator for insisting on this when the Act was enacted many decades ago. However, unlike conventional drugs, homeopathic medicines do not have to undergo the FDA new drug approval process. Pre-market approval for homeopathic drugs comes from the Homeopathic Pharmacopoeia of the United States (HPUS) monograph, which involves clinical verification of the efficacy of the substance. Despite federal law, the presence of an HPUS monograph has not protected homeopathic products from a lawsuit under California’s consumer protection law. This is creating an uncertain and expensive business environment for the homeopathic industry and could threaten the marketing of these products in California and other states. In the 2012 lawsuit of Delarosa v. Boiron, Inc., the plaintiffs alleged that Boiron, the world’s leading homeopathic manufacturer, falsely claimed that its Children’s Coldcalm product would provide relief from cold symptoms, in violation of California consumer protection laws. Boiron argued that the case should not go to trial because the plaintiff’s claims are precluded by federal preemption: the federal definition of a drug, as defined by the FD&C, includes homeopathic remedies like Coldcalm, which are recognized in the HPUS. The judge denied the preemption. He ruled that Boiron was not protected because the FD&C also contains a preemption exemption for products that aren’t marketed pursuant to FDA approval or final FDA regulation. Trial is set for later this month. The ruling is significant in that these two sections of the FD&C seem to be contradicting one another. As a result, it creates an opening to claim that the presence of a homeopathic drug in the HPUS is not sufficient under California consumer protection law to prove that the drug is effective. This isn’t the only California lawsuit attacking homeopathy. Here are some others. In Galluci v. Boiron, the plaintiffs alleged that Boiron made false claims regarding over twenty-four homeopathic products, that they could effectively treat ailments such as flu, arthritis, sore joints, joint pain, aches, fever, coughs, insomnia, or sleeplessness—again, in alleged violation of California consumer protection laws. Ignoring the principles of homeopathy, the plaintiffs also argued that Boiron’s products are so diluted that they are “effectively nonexistent” and are thus akin to placebo or sugar pills. This is akin to saying that because homeopathic preparations are not like standard drugs, they are fraudulent, exactly the kind of claim that federal protection under the FD&C Act was designed to prevent. Boiron settled the case for $5 million. It also agreed to place a warning on all its products that “Uses have not been evaluated by the Food and Drug Administration,” and to provide additional data on homeopathic dilution to consumers on their website. In Allen v. Hyland’s, the plaintiffs alleged that the defendants (Hyland’s and Standard Homeopathy) marketed their homeopathic products as having health benefits while knowing the products had no active ingredients in amounts sufficient enough to cause any beneficial actions, in alleged violation of consumer protection laws. The defendants were unsuccessful in getting the case dismissed, though they did manage to limit the suit to the seven products which plaintiffs actually purchased. The case is still pending. A couple of things to note here. In none of the cases did the plaintiffs say they were physically harmed. They merely claim that the products did not treat them as they stated they would, and that they suffered minor economic loss by purchasing the product. (So apparently if your cough medicine doesn’t work well enough for you, you get to sue the company!) Also, the plaintiff in two of these lawsuits is represented by the same attorneys, the Newport Trial Group. The law firm involved in the third case, Marron and Associates, has been accused by the Newport Trial Group of tracking their homeopathic class action suits and plagiarizing them, in an effort to attract clients to their own potential class actions against homeopathic companies. Did these law firms recruit the plaintiffs? Are they doing this in hopes of getting multi-million dollar settlements, much of which will go to lawyers? Is this just another chapter in the predatory California lawsuits linked to Proposition 65 that we have written about before? Those lawsuits are about supplements, and these lawsuits are about homeopathic medicines, but the pattern seems similar. The basic premise of the suits—that in the successive dilutions that homeopathic medicines go through to achieve their final potency, there may be no molecules of the original substance left at those concentrations— is not just an attack on these companies. It is an attack on homeopathy itself. Homeopathic researchers have always struggled to explain why their preparations seem to work, even though clinical evidence says it does. New scientific research may help. Using a laboratory technique called spectroscopy, researchers have found that different homeopathic medicines and different dilutions of the same medicine can be distinguished from each other, even though all should logically contain nothing but water. One explanation for this is that the repeated dilution and succussion (the forceful agitation of the liquid) during classical remedy preparation may break the substance into immeasurably small nanoparticles, that is, “top-down” nanostructures. A novel model for how homeopathic medicines work on living systems has been proposed by researchers Iris Bell, MD, PhD, and Mary Koithan, PhD, RN, CNS. The traditional theory, that some presence remains without actual particles, is of course more controversial. We will return to the scientific questions underlying homeopathy in another article soon. While homeopathic medicines do not go through the FDA drug approval process, they are absolutely reviewed for safety and effectiveness. The FDA recognizes the monograph published in the HPUS and administered by the Homeopathic Pharmacopia Convention of the United States, a nonprofit standard-setting organization. Currently, 1,286 official homeopathic drug products are recognized by the HPUS. Moreover, homeopathic drugs are subject to FD&C misbranding provisions, and must comply with Good Manufacturing Practice requirements. If homeopathic substance is “new” (that is, used after 1962), manufacturers most commonly gather evidence for safety and effectiveness through a method specifically designed for homeopathics called “proving.” What is happening in California is a real threat to homeopathy. As these cases proceed, we’ll keep you informed and also work to develop strategies to protect it from predatory lawyers and a hostile court environment.

“Monsanto Protection Act” Triggers a Firestorm of Protest and Public Outrage

ANH-USA — Tue, 09 Apr 2013 21:00:46 +0000

We now need to keep the pressure up on USDA not to slip more dangerous products through without review. Action Alerts! It’s being called the straw that broke the camel’s back. Bloomberg, The New York Times, Politico—media of all political persuasions—ran searingly critical articles about the biotech rider that the Senate slipped into the Continuing Resolution despite messages pouring into Congress via our and others’ alerts. The Daily Show mocked Congress, which may have gotten more attention than all the articles. Facebook and Twitter were ablaze with people like you telling their friends and neighbors about the provision, and the outrage was even greater once the legislation was passed. For a long time no one was stepping forward to claim responsibility for the rider, but we now know that the person behind the Monsanto rider was Sen. Roy Blunt (R-MO). In 2010, the year of his Senate run, agribusiness PACs gave him over $243,000. Back in 2005 the Washington Post wrote that Blunt had “converted what had been an informal and ad hoc relationship between congressional leaders and the Washington corporate and trade community into a formal, institutionalized alliance.” But Sen. Blunt didn’t work alone. The former Senate Appropriations chair, the late Daniel Inouye (D-HI), was “sympathetic” to Monsanto and allowed the rider into the Ag Appropriations bill before he died in December 2012. The biotech industry was not a big funder of Inouye’s campaigns, but there are a lot of biotech jobs in Hawaii, and clearly Monsanto had his ear. Sen. Barbara Mikulski became chairwoman only this past January, and it was rumored on Capitol Hill that she didn't want to ruffle any feathers right away—the rider would be difficult to remove, since it was allowed by Sen. Inouye who had died so recently. Sen. Herb Kohl (D-WI), who had resisted such riders in the past as chair of the Appropriations subcommittee responsible for the Ag budget, retired from the Senate at the end of last year, so there were no strong voices in the Senate who were willing to protest the Monsanto provision. Intense public pressure across the political spectrum—not to mention the outpouring of media coverage—finally caused Sen. Mikulski to assert her opposition to the “Monsanto Protection Act” and publically apologize. Here’s what she said: Senator Mikulski understands the anger over this provision. She didn't put the language in the bill and doesn't support it either. It was originally part of the Agriculture Appropriations bill that the House Appropriations Committee reported in June 2012, and it became part of the joint House-Senate agreement completed in the Fall of 2012 before Senator Mikulski became Appropriations Chairwoman. We appreciate the apology, but it’s “too little, too late,” as they say. The legislation passed, and it will have the force of law for at least the next six months. The biotech industry has good reason to want that legislation, as there are five very controversial crops being reviewed by the USDA right now—and of course GMO manufactures are requesting that these crops be deregulated. Action Alert! Please send your comments to USDA and tell the agency that these dangerous crops must not be deregulated. The comment period ends April 29, so please take action today.

GMO Freeze-Resistant Eucalyptus Action Alert

GMO Insect-Resistant Soybeans Action Alert

GMO Herbicide-Resistant Cotton Action Alert

GMO Herbicide- and Insect-Resistant Maize Action Alert

GMO Herbicide-Resistant Soybeans Action Alert

Seasonal Allergies Are Getting Worse Every Year

ANH-USA — Tue, 09 Apr 2013 19:00:14 +0000

Here are some natural ways to stop your body’s reaction and relieve your suffering! According to the Harvard Health Letter, seasonal allergies are starting earlier every year, and pollen counts are rising. At least 36 million people are affected by seasonal allergies each year in the US. Seasonal allergic rhinitis occurs when one’s immune system overreacts to foreign materials and produces an inflammatory response. Grass, weeds, and trees release tiny pollens into the air, and inhaling them triggers a reaction of your immune system. Floating pollutants such as mold spores and dust mite droppings also contribute (though in warmer climates, this can happen year round). Uncovering what makes the immune system respond the way it does is important. One theory is that an excessive antigenic stimulus overwhelms the immune system, and this is what leads to an inflammatory response. In other words, a small amount of allergen may not be enough to cause symptoms, but continued exposure—or the exposure of number of different antigens—can lead to an overload of the system. This is magnified when one’s immune system is weak (which happens easily when one is tired or stressed or has recently been ill). There are natural approaches to seasonal allergies that work well:

Calm the allergic response. According to a study in the Journal of Alternative and Complementary Medicine, subjects who took 2600 mg of MSM (methylsulfonylmethane) found their upper and total respiratory symptoms significantly reduced within seven days, and improvement continued for all thirty days of the study. Also, as Dr. Mercola notes, MSM is 34% sulfur, which can help maintain optimal health. Sulfur helps the body detoxify itself, and helps produce glutathione, an important antioxidant. MSM is extremely safe and can be taken at high doses, even if one’s diet is full of raw vegetables and MSM-rich foods. Some of our staff have found complete relief from allergies with this product, but required higher daily doses than 2600 mg.
Another substance that helps calm down the immune system under a pollen attack is the Alpine herb butterbur. In Scotland, researchers found that butterbur is effective. It can also be used in conjunction with MSM—the sulfur to condition the body, and the herb for acute attacks. Petadolex, a butterbur extract supplement, reduces inflammation so well that it can be used for migraines and other headaches too—it was endorsed as an OTC remedy for migraines by the Academy of Neurology and the American Headache Society after their review of 284 scholarly articles on the subject. Butterbur in the wild contains a potentially toxic substance, but Petadolex has removed it.
Freeze-dried nettles and quercetin are also used to reduce allergic response. They both work—the former sooner, and the latter over time—but they typically reduce rather than eliminate symptoms. Antihistamine drugs were initially developed from quercetin. As is often the case, the drugs had serious side effects (such as drowsiness) while the natural product from which it is derived did not. Another natural product that shows promise is Carnivora, derived from the plant of the same name, although more research needs to be done.
Remove food allergens (which lightens the antigenic load). As the Townsend Letter points out, allergic/inflammatory processes may first become active in the gut. Then transportation of food proteins across the intestinal wall becomes altered, resulting in increased permeability and motility of the intestine—Leaky Gut Syndrome. Coupled with other conditions, such as intestinal infections, flora imbalance, and decreased immunoglobulin A antibodies, this may lead to further intestinal compromise and increased antigen-immune interaction.
Get acupuncture. Researchers had 442 people with seasonal allergies receive acupuncture treatments. After eight weeks of acupuncture, a 71% patients reported an improvement in their symptoms (according to a scale used to measure allergy symptoms, the severity of these patients’ symptoms decreased by an impressive 37%).

Reduce general inflammation in the body. Eating lots of veggies with deep-water fish will decrease inflammation levels. Omega-3s from all sources can reduce inflammation as well. In Traditional Chinese Medicine, licorice, skullcap, cordyceps, and perilla have been shown to have anti-inflammatory properties (though consult a TCM practitioner for guidance).

Strengthen the immune system. At the head of our list is vitamin D3, which reduces the incidence of respiratory infections. Also get plenty of vitamin E and magnesium, and knock off the sugar, which greatly weakens the immune system. And don’t forget vitamin C: studies indicate it’s a natural antihistamine.
Relieve congestion gently. Don’t forget neti pots—saline nasal irrigation—which may provide sinus pain relief for allergy sufferers. But you probably won’t need them if you have enough sulfur in your system.

A Natural Health Trailblazing MD Needs Your Help

ANH-USA — Tue, 02 Apr 2013 19:00:02 +0000

What an embarrassment for Washington State! Action Alert! Last month we told you about the administrative hearing that integrative physician and natural health pioneer Jonathan Wright, MD, was subjected to. The Washington State Medical Quality Assurance Commission (MQAC) has been pursuing a decades-long vendetta against Dr. Wright and other integrative physicians. It all seems out of character for a state like Washington with its advanced technology and openness to new ways of living. You’ll recall that the case concerns a medical doctor who had been licensed outside Washington State. He joined Dr. Wright’s Tahoma Clinic under the condition that he apply for a Washington medical license. He did, and the doctor’s Washington license was listed as “pending” on the MQAC website. During this period, Dr. Wright followed legal advice he had received and monitored him closely as required by Washington law. MQAC then charged Dr. Wright with “aiding and abetting the unlicensed practice of medicine” because the doctor’s out-of-state license had been revoked—a fact that at least four MQAC staff members admitted they knew from the beginning, but never put on the MQAC website or told Dr. Wright about. Before last month’s hearing, MQAC requested that five patient files be sent to the commission. Dr. Wright did so, but he redacted the patients’ names, health problems, and treatment to protect their privacy. The point of the case files was to show that Dr. Wright was supervising the out-of-state doctor, a fact that was clearly indicated in the patient files. Redacting the patient-specific information is completely proper and legal. Would anyone want their private medical information to be reviewed by a state medical board without permission? MQAC complained about the redacted information. Dr. Wright wrote to MQAC asserting his rights to redact the information and pointing to the legal precedent allowing him to do so. Rather than responding to the letter, they simply added new “non-cooperation” charges to his list of supposed offenses. On the day before the hearing, Dr. Wright’s out-of-state lead counsel, a specialist in these matters, experienced some serious medical issues. He emailed the MQAC hearing’s presiding officer, asking for an emergency continuance and supplying all the necessary medical documentation. Lawyers are very courteous with each other as a rule, and such a continuance is common. But in this case it was denied. Dr. Wright also had an in-state attorney, as is usual, though he had not intended to present legal arguments at the hearing. He too asked for a continuance, since it would take him several days to review the extensive case files and get fully up to speed. Nope—the presiding officer only gave him the rest of the day to study. In the end, the out-of-state counsel had to fly to the hearing anyway—against the advice of his own physician. During the hearing, the “prosecutor,” a representative of the state Attorney General (AG)’s office roped in for such duty, claimed that the law regarding out-of-state licensed doctors “was not meant to be followed exactly as written,” and there should be limits to how much a doctor with a pending license should be allowed to do, although this is nowhere in the law. Moreover, the Assistant AG acknowledged that there was no evidence that Dr. Wright knew anything about the license revocation—which makes the charges all the more absurd, particularly since MQAC staff, by their own admission, knew from day one that the out-of-state MD’s medical license had been revoked in his own state. If anyone should be charged with “aiding and abetting the unlicensed practice of medicine,” it should be MQAC! Their negligence goes completely against their stated mission of “promoting patient safety and enhancing the integrity of the profession.” At the beginning of the hearing, in her opening statement, the Assistant AG said the outcome of the hearing will be “automatically appealed.” This is a giant red flag. MQAC is making the decision, so they’re not going to appeal their own decision. If the decision is rendered in favor of Dr. Wright, he certainly won’t appeal! The only reason for an appeal would be if Dr. Wright loses. The Assistant AG’s statement strongly implies that she knows the final decision already and that it will be adverse to Dr. Wright. The ruling will be issued 30 to 45 days after the hearing, which means we’ll likely learn the results by the end of April. If he loses, Dr. Wright will indeed appeal. Instead of an administrative court in which MQAC conducts its own hearing (which makes bias a very strong possibility), his case will be heard by a state superior court. Depending on the decision, it could be appealed further. All of this is, of course, extremely expensive. MQAC knows this. The commission can spend all the public money it wishes, and this is a way to intimidate doctors into admitting some guilt, even when innocent, in order to get a settlement and avoid financial ruin. Jonathan Wright, MD, isn’t about to buckle under this intimidation. He is a champion of natural health. He has developed innovative and successful natural therapies utilizing food, supplements, and lifestyle changes for a host of maladies that conventional medicine cannot cure. Now he needs your help. If you would like to help in his battle against an egregious injustice, we invite you to donate to the Dr. Jonathan Wright Legal Defense Fund. Please give generously. In addition, if you are a Washington resident and have not already done so, please contact your governor and state legislators about MQAC blaming—and threatening Dr. Wright with penalties—for a problem MQAC itself created! Please send your message today!

Pesticides Definitively Linked to Bee Colony Collapse

ANH-USA — Tue, 02 Apr 2013 16:00:56 +0000

Isn't it time the EPA listened to the science and not the insecticide manufacturer? Since 2006, up to 40% of the bee colonies in the US have suffered Colony Collapse Disorder (CCD), in which honeybees die, disoriented, far from their hives. In 2010 we wrote about the disappearing honeybee and how this situation threatened much of our human food supply, including our vegetables and fruits, which must be pollinated by bees. Back then we noted that there have been very few reported bee losses among organic beekeepers, and suggested that the principal difference between them is the use of pesticides. We said at the time that this fact should lead anyone to the most logical conclusion: pesticides are likely responsible for CCD. Now, a study by the European Food Safety Authority (EFSA) has labeled the pesticide clothianidin as being an “unacceptable” danger to bees. At least 143 million of the 442 million acres—that is, nearly one-third—of US cropland is planted with crops treated with one of three neuroactive insecticides related to nicotine (a newer class of pesticide called neonicotinoids), all of which are known to be highly toxic to bees: clothianidin, imidacloprid, and/or thiamethoxam. Clothianidin, which is used to treat up to 90% of US corn, much of canola, and increasingly soy as well, expresses itself through the plants’ pollen and nectar—the honeybee's favorite sources of food. In addition to finding clothianidin too dangerous to use on plants pollinated by bees, EFSA’s study specifically identifies the shoddy studies provided by pesticide manufacturer Bayer as evidence of clothianidin’s safety as “too flawed to be useful.” It was these studies that EPA used to first approve clothianidin in 2003, even against the objections of EPA’s own scientists. Three years ago we reported about Bayer’s involvement in a material conflict of interest surrounding its pesticide studies. At the time, a study had decided that a fungus tag-teaming with a virus was killing the bees—but the study’s lead author, Montana bee researcher Dr. Jerry Bromenshenk, had originally signed up to be an expert witness on behalf of beekeepers who brought a class-action lawsuit against Bayer in 2003. He suddenly dropped out—and immediately received a significant research grant from Bayer to study bee pollination, which has continued in recent years. It should come as no surprise that Bayer pesticides were never mentioned in the study as a potential cause of CCD. Now Bayer’s clothianidin has been linked to colony collapse in Minnesota and Ohio. And researchers at the Harvard School of Public Health, who studied imidacloprid (which has identical results), believe bees are being exposed either through nectar from plants or the high-fructose corn syrup that beekeepers use to feed bees. The problem is that farmers are not left with much of a choice, as most of the available seeds are already coated with the pesticide: either you buy the seed, or you don’t grow corn. Meanwhile, the Environmental Protection Agency seems to be turning a blind eye to the situation. Even though they acknowledge that pesticides kill bees, they hurry to differentiate this from colony collapse disorder. And when listing possible causes of colony collapse, pesticides are conspicuously absent. Are honeybees merely the canary in the coal mine? If pesticides that coat 90% of our corn are killing off bees, what is the impact of those same pesticides on humans? It is extremely difficult to get accurate information when the biotechnology industry is aligned against you. For example, Beelogics, a company whose primary goal is to control colony collapse disorder, has just been bought by Monsanto. That means any research from Beelogics may now be compromised. Monsanto develops GMO corn and soybeans that develop their own pesticides. If these also contribute to colony collapse, we may never hear of it. Even more frightening, government agencies always seem to side with industry. In Illinois, organic beekeeper Terry Ingram had accumulated fifteen years of research supporting his belief that Monsanto’s Roundup Ready crops cause CCD. But when he asked the Illinois Department of Agriculture to test one of his honeycombs for chemical contamination, since the bees wouldn’t touch it, the agency refused to test for chemicals but instead tested for foulbrood, a disease that affects bee larvae, and subsequently confiscated his bees, beehives, and equipment, and destroyed his fifteen years of research. Ingram calls it a subterfuge to destroy all incriminating evidence against Monsanto. Colony collapse disorder is very dangerous because bees are an integral part of the ecosystem—roughly one-third of crop species in the US are pollinated exclusively by honeybees, including fresh vegetables and fruits. If bees die off, half of the world’s food supply will disappear. Forget about the billions of dollars in agricultural losses: if we lose the bees, we will have worldwide famine of unprecedented proportions. On top of that, bees could hold the key to preventing HIV transmission. According to a study just published in the journal Antiviral Therapy, melittin, a toxin found in bee venom, physically destroys HIV virus without harming human cells. It’s a breakthrough that could potentially lead to drugs that are immune to HIV resistance. It could also be used for a topical anti-HIV gel, thus preventing transmission in the first place The vital importance of the humble honeybee is just one more reason why we should abandon the industrial farming model in favor of organic farming. Dangerous pesticides and genetically engineered foods are not needed, and in the long run they are proving costly both to the economy and to human health.

FDA-Approved Drug Linked to 542 Deaths and 2,367 Hemorrhages, but FDA Refuses to Pull It

ANH-USA — Tue, 02 Apr 2013 16:00:02 +0000

It couldn’t be because it brings in over $1 billion in sales each year, could it? Pradaxa (dabigatran) is an anti-clotting drug used to treat a type of irregular heartbeat called nonvalvular atrial fibrillation (AF) and to prevent strokes. It’s used as an alternative to warfarin, an older drug, and needs less monitoring (warfarin requires regular doctor’s visits, blood tests, and dietary restrictions). In clinical trials, Pradaxa outperformed warfarin in reducing the risk of stroke, and it initially appeared to be safer, causing less hemorrhaging. But that turned out not to be the case. In 2011, Pradaxa caused 542 people to bleed to death. FDA states that Pradaxa’s bleeding rates “do not appear to be higher” than warfarin, even though elsewhere on FDA’s website, we see that the risk of bleeding from Pradaxa is six times greater than with warfarin—usually in a pericardial location. Warfarin is also dangerous, and is one of the leading causes of emergency room fatalities. In 2011, warfarin was the subject of 1,106 serious adverse events, including 72 deaths. Warfarin’s greatest flaw is also its saving grace: its blood-thinning effects can be counteracted with vitamin K, found in the K1 form in abundance in green leafy foods. This means that warfarin stops its beneficial work if you eat too many leafy greens—but if you start hemorrhaging, vitamin K is a swift antidote. No such antidote exists for Pradaxa: if you start bleeding, you will bleed to death. The drug has spurred more reports of injury or death than any of the more than 800 drugs monitored by the Institute for Safe Medication Practices. To date, FDA has refused to recall the drug or address the “no antidote” issue. This exemplifies one of our great concerns about the drug approval process. How can the FDA approve a drug that causes uncontrollable bleeding with no antidote? It also calls into question the quality of the clinical studies and random-controlled trials. How can the initial trials have indicated that Pradaxa causes less hemorrhaging when it actually causes six times more? Clearly, trial results can be skewed to benefit drug manufacturers. Worse, since warfarin works, there was no urgent requirement for Pradaxa approval—or its continued presence on the market, now that it has been shown to be dangerous. The only thing that justifies its sale is the fact that it’s a big money-maker. It brings in over $1 billion a year—about $3,000 per patient, costing sixty times more than warfarin ($48 per patient). That’s a significant income for a drug that’s been on the market for only two years. By August 2012, more than 3.7 million US patients had filled Pradaxa prescriptions. The anticoagulant therapy market is estimated to bring in $10 billion a year in the United States alone. And it’s an expanding market. In Europe, for example, Pradaxa is used to treat venous thromboembolism (VTE) after knee or hip replacement surgery. Boehringer Ingelheim, the manufacturer, is currently having clinical trials for this indication, so it’s possible the drug will be approved for even more uses in the US. One of the problems is that the drug is usually prescribed by cardiologists, while the ones who see the consequences of bleeding are ER doctors. Conventional medicine is by nature a fragmented system. Though the FDA is refusing to take action, more than 100 lawsuits have already been filed and more than 1,000 are expected, even after screening out obviously fraudulent and questionable cases. Plaintiffs are planning a mass joint claim against Pradaxa’s manufacturer. The plan is to use multidistrict litigation instead of a class-action suit to speed up the process. This is not the first time FDA has approved a dangerous drug for atrial fibrillation. You may recall our report about Multaq, a drug that treated cardiac arrhythmias. Its clinical trial was stopped because more patients who were getting the drug were dying than those who received a placebo—though the study results weren’t published until five years later. Even so, the drug was approved by the FDA in 2009 as a treatment for AF in certain patients. Of course there is an abundance of natural treatments for AF and to prevent stroke. Dr. Robert J. Rowen points out that not only do drug-thinning drugs increase risk of hemorrhaging, they also stop vitamin K production, and vitamin K is responsible for helping blood to clot and, in the K2 form, is also important for getting calcium into bones: “The truth is most people with atrial fibrillation never develop clots. They have a clotting system that’s operating normally. Those who do develop clots have other non-heart risks for thick blood. These include deficiencies in nutrients that have been proven to help regulate the body’s clotting mechanisms.” He recommends omega-3 fatty acids, vitamin E, bioflavonoids (such as ginkgo), garlic, and nattokinase, a nutrient made from fermented soy, which optimizes your blood’s clotting system. In 2010 we noted that nattokinase also may remove amyloid plaque, so it may be a promising treatment for Alzheimer’s, in addition to other foods and supplements we’ve told you about. Other good natural methods of stroke prevention include obesity reduction, taking vitamin D to avoid sulfate deficiency (which could be an underlying cause of arterial plaque build up), and managing blood sugar levels. Dr. Rowen also recommends getting to the root cause of the AF rather than just treating its symptoms. He notes that hypothyroidism could be one root cause predisposing people to AF.

The Latest on the GMO Rider

ANH-USA — Tue, 26 Mar 2013 20:00:42 +0000

Where do we go from here? The Continuing Resolution (CR) to fund the federal government passed both the Senate and the House last week—and despite all our mutual efforts, it still contained the dangerous GMO rider we’ve been telling you about. The Senate, and in particular, the Senate Appropriations Committee leadership, let us down, despite earlier signals they would stand up to Monsanto on this one. Senate Democrats were unwilling to remove the biotech rider, despite the efforts of hundreds of organizations and businesses and tens of thousands of phone calls and Action Alert messages sent. As you’ll recall, the newly passed rider will strip federal courts of the authority to halt the sale and planting of illegal, potentially hazardous genetically engineered crops while USDA is performing an environmental impact statement. It will not only affect future judicial orders—it will also invalidate several recent orders that found the approval of GMO crops were unlawful, and will allow the planting of those GMO crops even while the USDA assesses environmental hazards. Since the USDA is totally behind GMO crops, removing court restraints really means that there are no controls on GMO planting at all. No safety reviews (USDA can’t even do them, only FDA, which refuses), and not even any real environmental assessments. This is one of the most blatant examples of money talking in politics that we have seen, and we have seen plenty of them in recent years. There is also a real question whether the rider is constitutional—how can Congress contravene judicial actions? That would seem to contradict the separation of powers doctrine. We will be reviewing this and other questions with legal counsel. Unfortunately, the Democrats were the ones who pushed this rider and allowed it to go through unhindered. What did they receive in return? This is the big unanswered question, as no one is willing to “take credit” for the rider. We spoke to the office of Sen. Richard Shelby (R-AL), the ranking member of the Appropriations Committee, and asked our lobbyists to see what they could find out, but we still did not get any answers. Barbara Mikulski, the Senate Appropriations Committee chairwoman, is not a big recipient of biotech funds, and she’s usually our ally on this issue—so it is even stranger that the rider’s language would arise out of her committee. Procedurally, it is irregular for a rider to become law that was not passed through the committee of jurisdiction first—in this case, the Judiciary or Agriculture Committee. In fact, Congress held no hearings on the biotech rider, and many Democrats on the committee were initially unaware of its presence in the CR in the first place. We do know that Monsanto and other biotech companies give a great deal of money to politicians. Opensecrets.org has not collated the information for 2013 as yet, but their figures reveal that contributions to both parties have increased dramatically in recent years. From 2011 to 2012, the agribusiness industry contributed $89,675,179 to political campaigns—65.9% to Republicans, 22.3% to Democrats—with Monsanto topping the list of contributors. The biggest recipients? In the Senate, it was Debbie Stabenow (D-MI) with $739,926 in agribusiness donations, and in the House, Frank Lucas (R-OK) with $720,590. However, neither of these individuals serve on the Senate Appropriations Committee, where the rider language was inserted. Technically, this CR will be in effect only for six months—its purpose is to fund the government just through September 30—and the GMO provision will expire when the CR expires. In practice, however, this will happen only when Congress enacts a 2014 Appropriations Bill, and it’s not likely they’ll have one written, debated, and enacted by September 30, the end of the 2013 fiscal year. If they don’t have a new bill by then, they will simply change the date on the CR and extend it once again—and everything will remain as it is, including the GMO rider. In other words, it’s extremely unlikely that the GMO rider will simply go away. Our only chance to end this provision is to make sure it doesn’t get included in the 2014 Appropriations Bill. This will require a huge and sustained grassroots effort—and a strong message to Congress to stop trying to sneak biotech riders by us. We as concerned citizens shouldn’t stand for it! ANH-USA will continue to work on lobbying, strategizing with various grassroots partners, and doing outreach. And we will, as always, keep you posted every step along the way. Editor's Note: It was revealed this week in a Poltico article that Senator Ron Blunt (R-MO) was behind the insertion of the Monsanto Rider into the passed government funding bill.

FDA Proposes to Drop the Effectiveness Test for Alzheimer’s Drugs

ANH-USA — Tue, 26 Mar 2013 18:00:16 +0000

OK. If they do, how about dropping the effectiveness test for food or supplements used to treat Alzheimer’s? Action Alert! The US Food and Drug Administration was originally charged only with ensuring the safety of foods and drugs. But in 1962, Congress passed the Kefauver-Harris Amendment, also called the Drug Efficacy Amendment. It put the FDA in charge of also ensuring the effectiveness of the drugs they approve—a task the agency has never shown itself qualified to handle. It also caused the cost of approval to soar because of the requirement to prove effectiveness with double-blind random-controlled trials (RCTs). This in effect created the “Catch 22” we talk about so often, the fact that only drug companies with synthetic patented medicines can afford to pay as much as $1 billion for approval. This in turn makes the agency hostile to natural (and therefore unpatentable) medicines. Now FDA is planning to loosen guidelines in approving new treatments for Alzheimer’s drugs. Companies would no longer have to show that the drugs improved daily, real-world functioning (such as dressing, feeding, etc.), which was an earlier requirement. FDA reasons that it has been too difficult for the pharmaceutical industry to test drugs meant for people either in the early stages of Alzheimer’s or at risk for it. Drug development for late-stage Alzheimer’s has also been very slow, as many drugs are failing to show improved real-world functioning in clinical trials. Under the new proposal, drugs in controlled clinical trials can qualify for approval if people at very early stages of disease subtly improve performance on memory or reasoning tests, before they develop any obvious impairments. The FDA would then require companies to study the drugs after they are placed on the market, to check whether they are truly preventive in warding off Alzheimer’s in the long-term. However, these post-marketing studies might not require RCTs. Critics note that it’s hard to test objectively for subtle cognitive changes. Billions may be spent on drugs that accomplish little or even do harm. It may take years to learn the safety, much less the effectiveness, of a drug. The new proposal appears to be timed to benefit companies like Eli Lilly, which is currently conducting clinical trials for an early-stage Alzheimer’s drug called solanezumab. The drug failed to show any improvement for late stage- Alzheimer’s, but under the FDA’s proposed new rule, it will be easier to get approval for it. We recently told you about another product Eli Lilly was testing for Alzheimer’s diagnosis called Amyvid. We aren’t comfortable with the timing of the FDA proposal, which is clearly intended to give drug companies a lucrative market monopoly for unproven but vastly expensive products created to take advantage of the widespread fear of developing Alzheimer’s. But we are not opposed at all to dropping the effectiveness requirement for FDA approval, in effect returning to the days before the Kafauver Act. Once the FDA has decided that something is safe enough to introduce, it should be left to doctors to decide what is effective and what isn’t. It isn’t that there won’t be studies—in fact, doctors won’t be convinced without them. The plain reality is that FDA is simply not qualified to make these decisions, no matter how many billions they throw at the problem, billions they get from drugs companies they are supposed to be reviewing, in order to present evidence to panels in many cases composed of people paid by the same drug companies. The Kefauver Act system is broken; it needs major reform and change. Meanwhile, if the FDA is going to lift the proof-of-effectiveness requirement for drugs, they need to do the same for supplements and food! Supplements cannot, according to FDA, claim to treat or prevent any disease unless they go through the full drug approval process and pay millions or hundreds of millions dollars to prove both safety and efficacy with new RCTs. No matter that humans and human ancestors have consumed vitamin C for millions of years and that we can’t live without it! It too would have to prove its safety and effectiveness as if it were a drug. Now, however, this standard is going to be lifted for certain drugs—no proof of effectiveness for real-world functioning needed before approval, with perhaps no RCTs required even after approval—and if so, at least let the same standard apply to natural foods and supplements! The reason supplements can’t meet the safety test is not that they are unsafe, nor the proof-of-effectiveness test because they don’t work. It’s because without patent protection and the ability to charge exorbitant prices for their products, nutritional supplement companies can never recoup their investment in the clinical trials. If the proposal for Alzheimer’s drugs were applied to natural foods and supplements, supplement manufacturers would be able to prove effectiveness without RCTs, while also having the opportunity to prove long-term effectiveness in post-marketing (i.e., observational) studies. Whatever the FDA does, it is important to include natural supplements and foods in any Alzheimer’s prevention or treatment plan, such as

coconut oil to help prevent or halt the progression of Alzheimer’s;
nattokinase and niacinamide to halt or even reverse memory loss;
fish oil that is high in DHA together with PhosChol and Uridine-300, mixed with small amounts of selenium, B vitamins, and alpha-tocopherols; and
vitamin D for healthy brain function.

Anyone worried about Alzheimer’s should be taking such natural preventive approaches—not taking hugely expensive, new-to-nature, and potentially toxic synthetic drugs even before they have the disease. Action Alert! There is a sixty-day comment period on the FDA’s proposal. Write to the FDA and tell them if they’re going to allow Alzheimer’s drugs to be approved without being able to prove their effectiveness, they need to follow the same standards for food and supplements that treat Alzheimer’s. Allow natural substances to make disease claims without having to spend a billion dollars to prove their effectiveness! Please send your message today!

URGENT Action Alert to Congress—Stop the Monsanto Rider!

ANH-USA — Tue, 19 Mar 2013 23:50:06 +0000

Last week we sent an emergency email to our subscribers about a terrible biotech rider attached to the big must-pass Appropriations bill that would let GMO crops be planted even when a court has ordered a stop. The Senate rejected this provision in the past—but now they may be accepting it as part of some back-room deal that was struck. Since last week, the Senate has been debating a Continuing Resolution (CR) for the big Appropriations funding bill (H.R. 933). Sen. Tester (D-MT) and three colleagues introduced an amendment to strike the biotech rider. Yesterday the Senate voted (63-35) to end debate on its version of the CR. They narrowly met this margin—60 votes are required to end debate on a bill. And unfortunately, the GMO rider is still in this final version of the bill. The Tester amendment to remove the language was not included in the final agreement to proceed and sadly will not voted on. Now the Senate will hold an up-or-down vote, possibly as early as today, on whether to pass the CR. This means it’s very likely the CR will be passed with the rider in it. This is the same rider we’ve told you about before—the so-called Farmer Assurance Provision (Section 735) of H.R. 933—that will strip federal courts of the authority to halt the sale and planting of illegal, potentially hazardous genetically engineered crops while USDA is performing an environmental impact statement. If this provision becomes law, it will be a huge blow to the justice system, completely overriding judicial safeguards that protect both farmers and the public, and rendering judges’ rulings irrelevant. This biotech-driven rider is simply an industry ploy to continue to plant GMO crops even when a court of law has found they were approved illegally. Sad to say, we were thrown under the bus with this amendment. It was included at the last minute and no senator is willing to take responsibility or be accountable for the amendment. The language came from the Senate Appropriations Committee, chaired by Sen. Barbara Mikulski (who has always been our ally on these issues in the past), and we can only guess that this issue was used as a bargaining chip and she got something in return for including the rider. We called the office of Sen. Richard Shelby (R-AL), who is the ranking member of the Appropriations Committee, to find out who is behind the amendment, but they did not comment. It’s not just that the biotech industry was extraordinarily sneaky to include the rider in this “must pass” funding legislation—the CR is a stopgap bill to avert a government shutdown next week and keep agencies operating through September 30, and this includes funding for the Pentagon. It also shows how much power the industry has— Congress is clearly dancing to their tune to allow the CR to be used this way. Once the CR passes the Senate, it will move to the House and Senate conference committee to resolve any differences between the House and Senate versions of the bill. Since this rider was not in the House version of the bill, there's a slim possibility the rider will not be in the final duly passed version. The general consensus on the Hill is that once the Senate acts, the House Appropriations Committee leadership is prepared to take the modified Senate CR directly to the House floor, possibly as early as Thursday. This is why urgent grassroots action is required to ensure that does not happen. Action Alert! Send your message TODAY to both chambers of Congress, and insist that the GMO language be removed. It has no place in a must-pass appropriations bill, and it’s a blatant, underhanded maneuver by biotech industry to thwart the protections of our legal system. Please send your message immediately!

Please note: Comments posted below WILL NOT be sent to Congress. To send a message to your representatives, please click on the "Take Action!" button above.

Durbin and Waxman’s Anti-Supplement Tactic Appears to Have Backfired

ANH-USA — Tue, 19 Mar 2013 23:40:51 +0000

A government report they hoped would say supplements are dangerous only proves how incredibly safe supplements are. A year and a half ago, Senator Dick Durbin (D-IL) and Congressman Henry Waxman (D-CA) tried a new tactic in their attack on supplements after earlier legislative failures. First there was Durbin’s failed 2011 Dietary Supplement Labeling Act, which he tried to reinsert into the 2011 Appropriations bill, and when that failed, he proposed an amendment to the Appropriations bill that included enabling the Government Accountability Office (GAO) to assess the effectiveness of the Adverse Event Report (AER) system and FDA’s enforcement action. When the amendment did not pass, he and Rep. Waxman went to the GAO directly and asked them to review AER data—but only for supplements. They wanted the FDA to determine “which supplements can cause and have caused severe health problems.” As we pointed out in our article at the time, the extremely biased FDA doesn’t have the tools to determine real supplement safety, and if Waxman and Durbin really cared about supplement safety, they would have asked the GAO to look at AERs for drugs and vaccines as well. (We’ll say more about that later.) Today, the GAO’s report on supplement AERs that requested by Sen. Durbin and Rep. Waxman was finally released. And it demonstrates overwhelmingly that supplements are safe! (Perhaps we should offer Durbin and Waxman a napkin. They appear to have egg on their face.) According to the GAO report, between 2008 and 2011, the FDA received 6,307 AERs for dietary supplements—an average of 1,575 per year. We already knew this; we had previously reported that FDA received 1,080 AERs in 2009, so the other years followed a similar trend. Considering the fact that, according to the GAO’s own report, over half the US takes supplements, that’s an incredibly low number of AERs from 157 million Americans. AERs may have increased from 400 in 2007 to an average of 1,575 in 2008, but that comes from an increase in the number of supplements being marketed, and more careful reporting of AERs to the FDA (especially after the implementation of required good manufacturing practice protocols). The GAO report notes that the National Poison Control Center received 1,000 more AERs than the FDA for supplements during same period; but as we have noted this is still a very low number, and our analysis of the 2010 Poison Control data revealed only a single death concurrent with supplement use—vaguely and probably irrelevantly concurrent with an “unknown dietary supplement or homeopathic agent”—with no deaths reported before 2009. By way of contrast, the same report shows that FDA-approved drugs caused 80% of Poison Control fatalities. More than 100,000 calls to Poison Control Centers, 56,000 emergency room visits, 2,600 hospitalizations, and nearly 500 deaths each year are attributed to Acetaminophen (Tylenol) alone. Today’s GAO report says that according to officials in the FDA office that regulates supplements, “The greatest challenge for identifying potential safety concerns from AERs is the small number of AERs that FDA receives related to dietary supplements.” Sen. Durbin and company are trying to spin that as if AERs were being underreported—while the real story is that there are probably very few AERs in the first place! We mentioned above that if Sen. Durbin and Rep. Waxman were truly concerned about safety, they would have asked that FDA-approved drugs and vaccines be included in the report. Here’s why they didn’t: when you compare the safety record of supplements to those of drugs and vaccines, you can see at a glance where the danger lies. In 2008 alone, there were 26,517 AERs for vaccines, with 3,923 of them considered serious, and a whopping 526,527 AERs for FDA-approved drugs, with 275,421 considered serious. Government-backed scientific organizations like the Institute of Medicine won’t even review AERs to study the safety of drugs and vaccines. Why not? The IOM says it will only look at peer-reviewed research on vaccine AERs, but won’t sponsor or even encourage any. It then concludes that vaccines are “safe” because there is no peer-reviewed evidence to the contrary—an explanation right out of Alice in Wonderland! The GAO report also reveals that there were only twenty problems connected to Adverse Event reporting requirements during inspections of supplement companies. In other words, it appears that the vast majority of supplement companies are following mandatory Adverse Event reporting requirements. Sen. Durbin’s plan, we believe, was to use this data to support new anti-supplement legislation, but he has come up short once again. It demonstrates that no further legislation is needed, just continued implementation of current law (good manufacturing practices and mandatory reporting of AERs by supplement companies). While we’ve confirmed Durbin isn’t planning to introduce legislation for the moment, that doesn’t mean he won’t in the near future, and we will continue to monitor the situation carefully.

Two Dangerous Bills in NY Show Anti-Supplement Bias

ANH-USA — Tue, 19 Mar 2013 23:30:02 +0000

One bill would give the health commissioner the power to ban any supplement deemed “harmful,” no matter how tiny the risk. A state-based Action Alert! The New York state legislature is considering two new bills that could have a devastating effect on supplements, and if they are successful, they may be copied by other states. The first bill (S.3650 and A.4700) will establish a Dietary Supplement Safety Committee that would create a system for adverse event reports; assess data and make recommendations to ban whichever nutritional supplements it deemed harmful; and establish a public health education campaign on dietary supplements. Most dangerous of all, the health commissioner would have the ability to ban supplements as recommended by committee. This would undermine the hard-won national regulatory system for supplements under DSHEA, the Dietary Supplement Health and Education Act of 1994—which was enacted to encourage access to nutritional supplements. Creating a “negative” list of supplements at the state level directly contradicts the process outlined by DSHEA and brings us one step closer to a system of approved vs. non-approved supplements. Remember, supplements aren’t allowed to state their full therapeutic benefits lest they be considered a drug by the FDA. Since it is illegal for producers to cite benefits in any but the most vague terms, the analysis will necessarily be one-sided, and any risk, no matter how tiny, may be deemed sufficient to have the supplement banned. Note that the same rule isn’t applied to OTC drugs like acetaminophen, which every year is responsible for 100,000 calls to poison control centers, 56,000 emergency room visits, 26,000 hospitalizations, and more than 450 deaths from liver failure. The bill isn’t clear about what system of adverse event reports (AER) it intends to create, but at the very least, it’s redundant: this already exists nationally. FDA collects AERs for dietary supplements, which manufacturers are required by law to submit. Consumers are encouraged to submit AERs to FDA. Making an additional state-level requirement will impose a greater burden on manufacturers, with absolutely no additional benefit to consumers. There are 409 times more serious AERs for drugs than for nutritional supplements, as we demonstrated in 2011. So why are supplements being singled out? Given the tone of the bill, it’s very likely the public health education campaign mandated by the bill will be biased against supplements. The problem, of course, is that only conventional medicine will likely be consulted; the integrative medical community has a very different idea of the benefits of supplements, as we saw when the Institute of Medicine made its absurdly low vitamin D recommendations. The second NY bill, SB.4151, would require that sport supplement manufacturers and distributors give the customer, along with every sports supplement sold, a pamphlet that discloses whether the product has been banned by certain sports leagues, the US Anti-Doping Agency, or the World Anti-Doping Agency, and whether it has any known negative adverse effects or known herb–drug interactions. The bill would also ban all sports supplements from being sold to people under age 18. Illogically, the bill excludes supplements in liquid form, as well as supplements containing caffeine (such as the five-hour energy drinks), which are the ones responsible for much of the controversy over supplements in the first place. Energy drinks often get marketed as supplements when they shouldn’t be, but the fact that the bill excludes this category altogether is strange, to say the least. We are strongly in favor of consumer disclosure and transparency. But this bill is badly written, and we fear it could be used as a hammer against the supplement industry by drug and other interests, and could also put more power over supplements into the hands of biased state agencies. Supplements have a remarkable track record of safety, and such state regulations do nothing to increase it—they would only diminish access. Consumers should be empowered to make responsible decisions when it comes to nutritional supplements:

Seek sound, professional advice before starting a supplementation program.

Consider whether the supplements are natural or synthetic, and learn whether there are co-factors you should take with any particular supplement.

Take note of the company making the supplement. Most good supplement companies are easily contacted, and are happy to share with customers their testing procedures.

FDA also has a database of illegal and/or tainted drugs being marketed as dietary supplements.

Access to supplements is an increasingly important consumer rights issue, with 68% American adults taking nutritional or dietary supplements, and 76% of that number classifying themselves as regular supplement users. Given these high numbers, the extremely low number of AERs received annually is a testament to their safety. Action Alert! If you are a resident of New York state, please contact your legislators immediately about these two bills, and urge them to oppose both bills. Send your message today!

URGENT! Stop the Monsanto Rider in the Senate!

ANH-USA — Wed, 13 Mar 2013 18:22:54 +0000

At this very moment, a Continuing Resolution (CR) for the big Appropriations funding bill (H.R. 933) is being debated in the Senate. It’s supposed to be about funding the government, but the Senate Appropriations Committee, chaired by Sen. Barbara Mikulski (who has always stood by our side in the past), has included a dangerous GMO rider that has no place in a funding bill. Fortunately, Senator Tester, joined by Senators Boxer, Gillibrand, and Leahy, have introduced amendment #74 to strike the dangerous rider from the CR. This is our one chance to ensure this heinous language does not become law. Tell your member of Congress to support the Tester amendment and dump the dangerous biotech rider. The good news is that this amendment is our best opportunity to halt the GMO rider before the bill goes to conference committee, which will reconcile the House bill (which was passed without the GMO rider language) with this Senate bill. The bad news is that during the previous Congress, the House passed a bill with this exact same GMO language, so if we don’t stop the rider now, the House is unlikely to oppose it. This is the same rider we’ve told you about before—the so-called Farmer Assurance Provision (Section 735)–that will strip federal courts of the authority to halt the sale and planting of illegal, potentially hazardous genetically engineered crops while USDA is performing an environmental impact statement . If this provision becomes law, it will be a huge blow to the justice system, completely overriding judicial safeguards that protect both farmers and the public, and rendering judges’ rulings irrelevant. This Monsanto-driven rider is simply a biotech industry ploy to continue to plant GE crops even when a court of law has found they were approved illegally. This is our moment—and perhaps our only chance–to be heard and have the GMO language pulled. Government funding expires on March 27, and the CR is a “must-pass” before that deadline, so we need a big push from you and other concerned citizens RIGHT NOW. Forward this email to everyone you know and urge them take immediate action by sending a quick message through our Action Alert system.

Then—and this is just as important—pick up the phone and call your senators today! We must tie up their phone lines to tell them they won’t be re-elected if they do not act to oppose this language! Follow this link to find your senators’ phone numbers—just choose your state from the drop-down menu. Please take action right away. Please don’t put it off! We can’t begin to express how important and urgent this is.

1. Send your Action Alert message

2. Phone both your senators

3. Forward this email to as many like-minded people as you can think of, post the Action Alert it to Facebook, and Tweet about it (use the hashtag #GMOrider).

FDA Now Censoring Consumer Free Speech on the Internet

ANH-USA — Tue, 12 Mar 2013 20:00:17 +0000

Or, to be more precise, demanding that supplement companies do it on their orders. Action Alert! The US Food and Drug Administration has recently issued warning letters to two different supplement companies. Here is what triggered one of them: supplement company AMARC Enterprises “liked” a Facebook customer testimonial about how their product helped “keep cancer at bay.” FDA says this means AMARC made a disease claim. Note that the customer did not even say that the product cured cancer, just that it helped keep the customer free of cancer. Regardless of what the comment was, are companies now responsible for customer comments on social media pages, an increasingly important form of communication and interaction between companies and the public? If a company stops allowing customer comments that might get it in hot water with the FDA, then the agency has censored consumer speech. Here is what triggered another FDA letter to a supplement company: on the website for M.D.R. Fitness Corp., if one types disease terms into the search box, one sees information about specific products. FDA claims this constitutes an “implied” disease claim. This goes too far. It means that even a sentence such as, “Living in a healthy way can help avoid cancer or heart attacks,” will be disallowed. Certain words will be absolutely forbidden. This is a very slippery slope. Once this line is crossed, how far will the FDA go? What is behind all this craziness? Under the Food, Drug, and Cosmetic Act (FD&C), a drug is defined as a product “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.” FDA regulates health claims made on product labels (including supplement labels). Under this “intended use” doctrine, the FDA can conclude that a product is a “drug” based solely on a company’s promotional claims or, as with last year’s federal appeals court case of US v. Caronia, statements made by an advertiser or promoter. For example, garlic becomes an illegal drug if an advertiser claims that the product will cure food poisoning, even though this is verifiably true. Similarly, manuka honey becomes an illegal drug if a seller mentions that it will stop skin infections (also verifiably true, as even the New York Times has reported). There are many, many such examples. The “intended use” doctrine can also magically change many non-traditional products into drugs or medical devices. For example, last year the FDA said the agency would likely regulate medical mobile apps on smart phones and tablets because they essentially transform a device into a regulated medical device. Developers of the apps would not be considered medical device makers unless they were marketing the product as being intended for medical uses—not unlike FDA’s approach to supplements. Now Congress is concerned about whether manufacturers of such apps will be subject to excise taxes under the Affordable Care Act. FDA’s new warnings seem to defy the judge’s decision in US v. Caronia which, as we noted in December, mostly underscored protections of free commercial speech. FDA is using a very broad interpretation of what constitutes a disease claim, explicit or especially implied. As any Facebook user realizes, a “like” may simply be a passive acknowledgement of someone’s comment; surely it is a stretch to consider any comment that even mentions cancer to be a disease claim! It is notable that FDA decided not to appeal the US v. Caronia ruling because the agency “does not believe that the Caronia decision will significantly affect the agency’s enforcement of the drug misbranding provisions of the Food, Drug, and Cosmetic Act.” With these latest warning letters, they’re certainly acting as if the Caronia ruling never happened. They may, however, be a little worried. The agency buried the above warnings amid a list of other alleged infractions. The agency seems to be trying to expand its Internet regulatory reach in a piecemeal under-the-radar fashion. We need to let them know we are noticing. We also need to pass the Free Speech About Science Act. Action Alert! Tell the FDA to stop trying to censor consumer free speech and Internet searches! Let the agency know it has gone too far. Send your message today!

Dairy Industry Tries to Hide Artificial Sweeteners in School Lunches

ANH-USA — Tue, 12 Mar 2013 19:00:29 +0000

Aspartame is already allowed in your kids’ milk. Now they want to erase it from the labels. Action Alert!

The International Dairy Foods Association (IDFA) and the National Milk Producers Federation (NMPF) are petitioning the FDA to let them remove any reference to non-nutritive sweeteners, mainly aspartame, from milk labels in school lunches. They claim—in one of the most spectacular failures of logic we’ve ever seen—that not labeling the milk “promotes honesty and fair-dealing in the interest of consumers.” Huh?

Non-nutritive sweeteners are already allowed and included in the flavored milk used in school lunch programs. Many school children already drink flavored milk, so this gives the dairy industry a bigger market share while also falling within the low-calorie guidelines of the USDA School Lunch Program.

Of course, the intent of the program guidelines is to provide healthier meals for children, so aspartame already violates the spirit of those guidelines. Aspartame is an extraordinarily dangerous and potentially carcinogenic chemical. Now they’re trying to remove FDA labeling requirements, arguing that labeling requirements makes the milk less attractive to children and might mislead children on the overall nutritive value of the milk—though they provide no data to back up this claim.

Labeling is important for children (and parents), who have a right to choose milk without aspartame or other non-nutritive sweeteners—chemicals which have no place in school lunch program in the first place. By removing this labeling requirement, consumers won’t know the difference between artificially flavored milk and regular milk—and we’d be denied the right to choose milk that doesn’t contain artificial sweeteners and flavorings.

School lunch is big business. USDA provides $1 billion each year to buy food for the program. Dairy has a vested interest in following the guidelines that qualifies them for the program, though they’ve balked at disclosing just how they are meeting those guidelines.

Here’s an example of how powerful the chemical sweetener industry is: a human aspartame study at Harvard spanning a whopping twenty-two years, funded by grants from the National Institutes of Health and the National Cancer Institute, found a clear association between aspartame consumption and non-Hodgkin’s lymphoma and leukemia in men. But not a half hour after the study results were revealed, Harvard caved to pressure from industry and issued a press release that minimized the impact of the study, calling the findings “equivocal” and the data “weak,” when in fact the opposite was true.

As we reported in 2011, aspartame also decreases the ability of the body to absorb tryptophan and reduces serotonin levels. Ten percent of aspartame is methanol, which is converted to formaldehyde which, in turn, is converted to formic acid—which is used to strip epoxy! The other 90% is composed of phenylalanine and aspartic acid. These amino acids are normally harmless, but in isolation they are neurotoxic. Aspartame has also been implicated in the development of Gulf War syndrome. Huge amounts of diet drinks were shipped to Gulf War troops, who were drinking it in high temperatures. In 1985, Coca-Cola apparently expressed reservations about proposed FDA approval of aspartame for beverages, noting that aspartame is uniquely and inherently unstable and breaks down in the can. When stored or heated above 85 degrees F, aspartame may decompose into formaldehyde (embalming fluid), methanol (wood alcohol), formic acid (ant sting venom), diketopiperazine (an agent in brain tumors), and other toxins. This of course didn’t stop Coke from eventually deciding to use it. Aspartame was approved only because of the revolving door between industry and the FDA.

Not only are such artificial sweeteners unhealthy, but so are the artificial colors found in kids’ drinks, which can lead to hyperactivity, allergic reactions, and possibly even cancer.

The dairy industry petitioners are using school lunch program guidelines as a foot in the door. They also want to remove labeling requirements for seventeen other dairy products included in the petition, even though they have nothing whatsoever to do with the school lunch program.

Action Alert! Please tell FDA to oppose this petition. Tell them how important truthful and complete labeling is—not only for school lunches but on all the foods your family eats. Tell them the dangers of aspartame and other non-nutritive sweeteners, and make them do their job of protecting the public. Send your message today!

New Study Touts Big Health Benefits of Resveratrol

ANH-USA — Tue, 12 Mar 2013 18:00:52 +0000

Big Pharma is drooling over the prospect of getting it all to themselves. Resveratrol, a substance found in the skin of red grapes as well as in pomegranates and Japanese knotweed, has been a popular dietary supplement for many years. It has anti-inflammatory and antiviral properties, possibly the potential to extend life, prevent several different cancers, protect the heart, ameliorate common diabetes symptoms, and control plaque in the brain and otherwise help with Alzheimer’s disease. And that isn’t even a complete list. It’s clear why drug companies are excited. Resveratrol is widely available as a dietary supplement—but may not be for long if we are not vigilant. A new study has thrown the excitement over resveratrol into high gear. Results from ten years of research have just been published by David Sinclair, a Harvard Medical School genetics professor and the study’s senior author. The research validated earlier findings that resveratrol may protect against age-related diseases because it turns on the SIRT1 gene that recharges mitochondria. Sinclair’s earlier research was partly discounted by other scientists in 2009 and 2010. They suspected that resveratrol might only seem to activate the SIRT1 gene because studies used a synthetic fluorescent chemical to track the effect. Since these synthetic chemicals are not found in nature, they reasoned, the experiment is not reproducible in humans. In this study, however, Sinclair used naturally occurring amino acids to track the benefits, which affirmed the compound’s benefits. Sinclair is not a disinterested party. He is the founder of Sirtris Pharmaceuticals, which focuses on developing resveratrol drugs, that is drugs that will mimic resveratrol’s effects with new and thus patentable molecules. Pharmaceutical giant GlaxoSmithKline (GSK) acquired Sirtris in 2008 for $720 million. GSK subsequently abandoned its work on resveratrol-based drug SRT501 because the drug didn’t appear to work on cancer patients and worsened kidney damage. It’s likely, however, that the new findings will prompt GSK to restart its work on a resveratrol-based drug; resveratrol is already the subject of at least two dozen clinical trials. Because Resveratrol is also the subject of an investigational new drug (IND) application, GSK could petition FDA to ban natural resveratrol. Yes, that’ s how warped the law is. Apply for FDA approval for something synthetic, new-to-nature, and thus potentially much more dangerous, and you can then try to ban the natural substance on which your product was based. This is governed by a provision in the law, as we explained last year. There is an absolute prohibition against banning the natural substance if it is grandfathered (that is, marketed before 1994) or if the FDA has accepted a New Dietary Ingredient (NDI) notification from supplement manufacturers. Supplement companies have tried to file NDIs for resveratrol, but the FDA has rejected them all, stating that an IND had already been filed, so they won’t accept an NDI. Despite resveratrol being a natural component of food and a constant part of the food supply, it may be hard to prove that it was marketed before 1994. This, of course, merely reveals the illogic of the grandfathering process: it was put in place as a means of proving the safety of an ingredient, but instead it’s being used to protect the pharmaceutical industry. New drug applications (INDs) are confidential, but we can make an educated guess that Sirtris Pharmaceuticals is one of the companies that filed an IND since they have already started clinical drug trials (an IND is required before clinical drug trials). If they are successful, resveratrol will then be available in an expensive, synthetic drug form, likely requiring a prescription at a very high cost and a disease condition for access. It will be tempting for the drug company to then try to have the FDA ban the natural form of resveratrol. It is our job to prevent that by making it painful for both the company and the FDA. In this context, let’s remember what happened to pyridoxamine, one of the three primary natural forms of vitamin B6. Biostratum, the North Carolina-based manufacturer of a planned pyridoxamine-based drug called Pyridorin, petitioned the FDA for market exclusivity, and FDA kowtowed, effectively prevented any substance containing pyridoxamine from being marketed as a dietary supplement. To date no drug has even appeared, so we have neither natural B vitamin nor drug, an outcome that is all too typical of FDA illogic and misuse of power. A similar petition has been filed regarding P5P, the natural form of B6 that is most bio-available. All other forms of B6 must be converted by the body to this form to be used, and without it we would all die. Is this really something to ban and make into an exclusive, prescription-only drug? (If you have not already done so, please send your message to FDA and Congress to make sure P5P remains available as a supplement.) If the dietary supplement version of resveratrol becomes threatened, rest assured that ANH-USA will be with you on the front lines, fighting to maintain your access to this amazing nutritional ingredient.

Judge Revokes Bloomberg’s Ban on Extra-Large Sugary Drinks

ANH-USA — Tue, 12 Mar 2013 17:00:03 +0000

“Arbitrary and capricious,” the judge called it. Last year we pointed out that the mayor also has the science wrong. Last June, in an attempt to combat the obesity epidemic, New York City Mayor Michael Bloomberg asked the city’s Board of Health to ban the sale of sugary drinks larger than sixteen ounces by movie theaters, restaurants, mobile food carts, and delis—though not grocery stores or convenience stores, so 7-Eleven’s Super Big Gulps (40 ounces) and Double Gulps (50 ounces) would be safe! The ban specifically exempted diet drinks, which suggested that he felt diet drinks are much healthier alternatives to the ones filled with high-fructose corn syrup (HFCS). On Monday, one day before the ban was to take effect, a state Supreme Court justice, Milton A. Tingling, Jr., struck down the plan in a harshly worded opinion. He said the ban’s broad exemptions, which included fruit-based drinks, dairy-based drinks, and alcoholic beverages, made it unenforceable and unworkable (the rules would create “uneven enforcement, even within a particular city block, much less the city as a whole”). Besides, it was just the oversized containers that were banned—one could just as easily buy two sixteen-ounce cups instead of one thirty-two ounce cup. Judge Tingle also stated that the Board of Health overreached by instating the ban—any such authority actually rests with the City Council. We should note that the ruling doesn't address whether the ban was legal or not—just the fact that it was unworkable and unfair; this might have an impact on similar proposals put forward in Los Angeles and Cambridge, Massachusetts. Mayor Bloomberg said he would appeal the decision. Aside from the paternalistic nature of the ban, our greatest concern was that it failed to look at just how dangerous diet drinks can be. As we noted last year when the ban was first proposed, Aspartame and Neotame (Equal and NutraSweet), which are used in more than 6,000 diet products, beverages, and pharmaceuticals, have carcinogenic effects at a dose level within the range of human daily intake—effects that are magnified when exposure begins during fetal life. Aspartame can cause grand mal seizures in people (and animals) not otherwise susceptible to them. And diet sodas in general are linked to a 61% increase in strokes and heart attacks, according to the American Stroke Association. (And now the dairy industry is trying to hide aspartame in the milk our kids drink as part of the school lunch program!) Of course, sodas containing HFCS are dangerous too. Recent brain imaging tests show that fructose can trigger changes in the brain that may lead to overeating—leading directly to obesity and related health problems. The beverage industry launched a multimillion dollar campaign to oppose the ban, but even if the ban had gone into effect, soda peddlers were planning to work the loopholes. Retailers were planning to allow customers to simply add their own sugar and sweeteners. Starbucks was planning to ignore the ban altogether. Rather than government-enforced bans (or, at the other end of the spectrum, government subsidies on sugar or corn for HFCS!), consumers should be educated about how sodas, whether sugary or artificially sweetened, affect their health. People need to be empowered to make their own decisions about what they eat and drink and how they treat their bodies.

Washington State Medical Board Endangers Public Health and Safety

ANH-USA — Tue, 05 Mar 2013 22:00:37 +0000

Worse, it continues its decades-long vendetta against medical giant Jonathan Wright, MD. Action Alert for Washington State residents! Any list of the greatest integrative physicians of America would include Dr. Wright. He is a pioneer who has developed innovative and successful natural therapies utilizing food, supplements, and lifestyle changes for a host of maladies that conventional medicine cannot cure. His style of medicine represents our future. The Washington State Medical Quality Assurance Commission (MQAC—yes, that would be pronounced M-Quack) does not like this. It has attacked and harassed Dr. Wright at every opportunity, often with trivial charges. The latest charge is far from trivial. And it represents a case of where the Commission is blaming Dr. Wright for a mistake that was actually made by the Commission. MQAC has now scheduled a three-day hearing March 18–20. This famous doctor’s license to practice medicine in Washington state will be at stake. Here are the facts. A medical doctor joined Wright’s Tahoma Clinic in September 2007. Prior to his seeing patients, Tahoma Clinic employees checked the MQAC website, which listed the MD’s Washington State medical license as “pending.” An attorney for Tahoma Clinic had informed Dr. Wright that it is legal for a medical doctor with a pending license in Washington State to work with patients if he (or she) is supervised by another physician licensed in Washington. Dr. Wright supervised him very closely, reviewing every one of his patient visits from September 2007 through January 2008. After that, Dr. Wright met with the MD once a week, and weekly reviews of patient records continued until the MD left Tahoma Clinic (and the state of Washington) in April of 2009. Tahoma Clinic employees continued to check the MQAC website every month while the MD was at Tahoma Clinic, and for the entire time, his medical license was listed as “pending.” Despite supervised practice being completely legal, the MQAC has now charged Dr. Wright with “aiding and abetting the unlicensed practice of medicine”—claiming that this somehow endangered the health and safety of the citizens of Washington. Legal proceedings followed. During the deposition of an MQAC official by Dr. Wright’s attorney, the official admitted that one department at MQAC actually knew from the very start of Washington State’s licensing process that this MD’s medical license (outside of Washington State) had been revoked—but this information was never posted on MQAC’s website for Tahoma Clinic employees or the public to see. MQAC’s website continually listed the MD’s license status as “pending” the entire time he was in Washington State. Had MQAC at any time informed Dr. Wright of what its own official admitted MQAC knew all along—that this MD’s medical license had been revoked in another state—Tahoma Clinic and Dr. Wright would have stopped the MD from seeing patients immediately. But MQAC did not inform anyone, either directly or by changing the website information available to the public—for the entire time the MD was in Washington State. It continued to say that the MD’s Washington license was “pending.” It is not known whether the withholding of this important information was the result of error or was done deliberately. However, if there was indeed any endangerment of the health and safety of the citizens of Washington State, it was the action (or inaction) of MQAC itself that caused that endangerment. Some suspect that this key information was deliberately withheld to entrap Dr. Wright, pointing to MQAC’s decades-long pattern of harassment of him and other integrative physicians in the state. There was no patient complaint or allegation of harm against the MD in this MQAC investigation, just as there was no patient complaint or allegation of harm in the prior two MQAC investigations of Dr. Wright and Tahoma Clinic:

In 2007, MQAC sent a letter to Dr. Wright telling him they were investigating the Tahoma Clinic telephone system, alleging that “all incoming calls go to voice mail” with “the potential of harm to the patients.” Although Dr. Wright and Tahoma Clinic wondered how it would be possible to stay in business at all if “all incoming calls go to voice mail,” they were forced to go through the process of defending their telephone system. Two years and $35,000 in attorney fees later, the investigation was dropped—with no changes at all to the telephone system.
In 2006, MQAC sent a letter to Dr. Wright alleging that a number of procedures described on the Tahoma Clinic website were “inefficacious.” Procedures described on the website included chelation therapy (which has been studied by the National Institutes of Health with generally positive results), colon hydrotherapy, intravenous ozone, and non-invasive sensitivity screening. Legal proceedings ensued; more than $20,000 in legal fees later, the investigation was settled, and descriptions of these procedures were removed from the Tahoma Clinic website. It was later discovered that the entire investigation was based on a single email communication to MQAC by an MD member of “Quackwatch,” who posts on her website that she blogs about “quackery, healthfraud [sic]…and other forms of so-called ‘Alternative’ Medicine.”

These last two investigations of Dr. Wright pale beside what happened in 2006 to Dr. Geoffrey Ames of Richland, Washington, another respected practitioner of integrative medicine. He saw a patient who had a positive antibody test (IgG4 RAST) for egg white and egg yolk. Dr. Ames explained treatment options for this problem, including not eating eggs at all, and desensitization to eggs. To achieve desensitization, Dr. Ames sometimes used a combination of kinesiology and EAV (a non-invasive electronic device), which he recommended to be used for this patient. Although no treatment was actually given, and no harm at all was done, the patient subsequently wrote a letter to MQAC complaining about the EAV device. MQAC charged Dr. Ames with “moral turpitude” (yes, the same charge used against sex offenders and child molesters), violations of interstate commerce (which is a federal, not a state responsibility) and intrastate commerce, and unprofessional conduct for using a device which the Commission alleged was simultaneously “ineffectual” and capable of causing harm to the patient! (No one has ever been hurt by an EAV device; many people, but of course not all, have been helped by the information it yields.) Although the charge of “moral turpitude” (which of course was made public) and violations of interstate and intrastate commerce were later dropped, and no patient was harmed in any way, the Commission suspended Dr. Ames’s license for five years! In a perfectly transparent attempt to force Dr. Ames to practice “conventional” medicine (against both his conscience and the best interests of his patients), MQAC stayed the suspension on several conditions: that he meet with the Commission and submit to interrogation every six months at a location over 200 miles away, and that he send in chart notes from ten allergy patients every three months along with a signed affidavit that he is not using his EAV machine. For comparison, let’s take a look at the penalties handed out by the Commission to “mainstream” physicians involved in actual cases of injury to a patient, or even death. Except for the text in brackets, the two examples below are verbatim from the Washington State Auditor’s report:

Violation/Conduct

[MD #1] failed to appropriately treat a sickle cell crisis in Patient A. Patient A suffered significant, permanent neurologic injury.

Sanction Imposed [by MQAC]

Submit paper of no less than 1,000 words, with references, regarding current recommendations for prevention and treatment of stroke in pediatric sickle cell patients.

Reimburse costs to the Commission in the amount of $1000 within 90 days.

[Auditor’s] Comments

Per the sanction guidelines for practice below the standard with significant patient injury, the range is suspension for 5 years to indefinite suspension or permanent revocation.

Violation/Conduct

[MD #2] performed a laparoscopic oophorectomy [ovary removed through a small incision in the abdomen] on Patient A. [MD #2]’s laparoscopic procedure resulted in perforation of the small bowel. This is a rare but recognized complication of this procedure. [MD #2] was not aware of the complication at the time of discharge. [MD #2]’s system of follow up contact with the patient during the first post-operative hours was insufficient to learn of the patient’s signs of distress in time to effect life-saving repair surgery.

Sanction Imposed

Respondent shall submit a paper of no less than 1000 words within 90 days on trochar [a surgical implement] injuries related to endoscopic procedures and response systems for bowel, ureteral, or bladder injury.

Within 90 days, submit a policy regarding postoperative follow-up on outpatient surgery patients, and a plan for, or description of, the implementation of this policy.

Pay $1000 for the administrative costs incurred in this case.

[Auditor’s] Comments

Sanction does not appear to be appropriate because per sanction guidelines, the sanction range for practice below standard with patient harm is probation or suspension for 2 years to suspension for 7 years to revocation.

We have written before about the problems at state medical boards that range from incompetence to bias to attempts to enforce monopoly medicine to outright corruption. For example, see our reports on the much-investigated Texas Medical Board. You would think that Washington State would be a place that would be accepting of integrative medicine, with its emphasis on diet, supplements, and lifestyle, as a supplement to conventional drugs and surgery. But think again. The Commission’s decades-long vendetta against a giant of contemporary medicine is a black mark against the state. MQAC should be ashamed of itself for mindlessly attacking Dr. Wright on ridiculous grounds, for blaming him for its own mistakes, and for an arrogant refusal to follow its own rules. It took a lawsuit to start to turn the Texas Medical Board around, and it will probably require a lawsuit against MQAC to get its attention. ANH-USA has begun consulting with our legal counsel. Meanwhile, if you are a Washington resident, you can help. Action Alert! Please contact your governor and your legislators about MQAC blaming—and threatening Dr. Wright with penalties—for a problem MQAC itself created! You can in addition call 1-800-562-6000; your call will be routed to your state senator and your two state representatives. The MQAC hearing begins on March 18, so please send your message today!

Should You Have to Fight FDA Red Tape to Save Your Life?

ANH-USA — Tue, 05 Mar 2013 21:00:12 +0000

An upcoming congressional bill would give dying patients and physicians access to experimental drugs. Action Alert! Imagine you’re terminally ill and have exhausted all the available treatment options. Your physician recommends a new, experimental treatment for your condition, but you’re ineligible to participate in ongoing clinical trials. You ask the drug company for treatment outside of their trials, but they say you have to go through the FDA first. Time’s running out, and you have to obtain permission to try to save your life—from the government! And you may never get permission. This situation isn’t some Orwellian hypothetical situation: it’s a reality for thousands of dying patients. That’s why last year, former congressman Ron Paul introduced the Compassionate Freedom of Choice Act, which would have allowed terminally ill patients access to experimental drugs without FDA approval. Though the bill was left in the House, its supporters are not giving up. In fact, Representative Morgan Griffith of Virginia recently told us he will reintroduce the Act in Congress soon! As we reported last May, the FDA does let terminally ill patients try experimental drugs and treatments under its “expanded access” rule. This allows the case-by-case use of an investigational new drug outside of a clinical trial if a patient has a serious or immediately life-threatening disease or condition and has no other treatment options left. Unfortunately, the rule is woefully inadequate, marred by a prohibitively cumbersome application and documentation process. And remember, FDA can arbitrarily refuse access and even revoke permission once it’s granted! The application for expanded access requires a drug company to share information—which we all know drug companies don’t do very well. It also requires, among other things, a detailed description of how and where a drug will be produced; complex pharmacological and toxicological information; and, if enough patients ask for the drug, a whole new Investigational New Drug (IND) application by the drug company. Furthermore, in what can only be described as a very bad joke, the FDA can deny expanded access if it deems the risks of an experimental drug too great for someone who is already terminally ill. Essentially, dying patients can be denied access to a drug because it could potentially make them sick. What the patient’s doctor thinks doesn’t matter. Passing the Compassionate Freedom of Choice Act would erase all of these problems by removing the FDA middleman entirely from the equation, streamlining physician and patient access to experimental drugs. It would ensure that dying patients and their families—who don’t have the time or the strength to do so—won’t have to wage fruitless bureaucratic wars. The heartbreaking story of Abigail Burroughs illustrates the need for the Act: shortly after turning twenty-one, Abigail ran out of conventional options in her battle against cancer. Abigail and her family turned their focus to obtaining one of two experimental cancer drugs that doctors felt had great promise of saving her life. Her efforts—thwarted by both the FDA and drug companies—were unsuccessful, and she died in 2001. Both drugs were eventually deemed safe by the FDA. Under the Act, drug companies can still deny dying patients access to experimental treatments. But if they don’t have the FDA breathing down their necks, drug companies may be much more willing to say Yes. For example, drug companies are often afraid that if a patient dies under expanded access treatment, it will affect the eventual approval of the drug. Also, the FDA’s expanded access rule currently creates mountains of extra paperwork for drug companies and doctors. With less risk and less paperwork, drug companies are more likely to increase patient access to experimental drugs. Detractors of this excellent bill may argue that FDA intervention is necessary to protect desperate patients from risky, untested drugs. However, full disclosure is a key component of the current draft of the Act, which states that in order to obtain an experimental drug, patients must first sign an informed consent document stating that they’re aware of the potential risks and benefits. Additionally, patients will need to work closely with their doctors (who will ultimately be the ones administering the experimental treatment), so it’s not as if they’re making important decisions without medical oversight. They say only two things in life are certain: death and taxes. The government already mandates taxes; should they really mandate how terminally ill patients die, too? Action Alert! Please write to your congressional representative and ask him or her to support and become a sponsor of this vital legislation. Also ask your senator to introduce similar legislation in the Senate. Please send your message today!

Organic Standards in Danger—Unless You Make Your Voice Heard

ANH-USA — Tue, 05 Mar 2013 19:00:50 +0000

It’s like they’re saying, “Ssh! If we keep quiet enough, nobody will complain!” Let’s not let them get away with it. Action Alert!

The National Organic Standards Board (NOSB) will hold its spring board meeting in April. As you probably know, NOSB is the governing board created by Congress that reviews all synthetic and non-organic materials proposed by Big Farma before they can be used in organic farming or food production.

For thirty days before each meeting, the public is supposed to be invited to scrutinize and comment on the topics that will come up at the NOSB meetings—a wide range of issues that significantly affect organic standards—and the USDA’s National Organic Program (NOP) is supposed to announce it. This time, however, the NOP failed to send out any public announcement about the thirty-day comment period, not even in their own e-newsletter, before the comment period began. The Cornucopia Institute discovered information about the April meeting, buried deep in the NOP website, after the comment period had already begun. Two days after the Cornucopia article appeared, NOP made the public announcement through their Organic Insider newsletter, costing stakeholders valuable time. Had this information been buried by mistake or on purpose? We don’t know.

Thank goodness Cornucopia discovered it, because public comment is vital to keep the NOSB accountable in the face of an increasingly cozy relationship between NOSB and Big Farma, and a serious dilution of organic standards. For example, the list of synthetic ingredients that are allowed in Certified Organic products is growing. As we reported previously, in 2002, the NOSB allowed only 72 chemicals. Since then, over 250 more chemicals have been added.

The majority of organic brands are owned by the biggest food manufacturers, and some them have seats on the NOSB. In 2011, a General Mills executive was on the board, and this year an exec from Driscoll’s, which markets both conventional and organic berries, held a seat on the board that was supposed to be filled by a farmer. After public outcry she resigned—but rejoined the NOSB in a different capacity.

Issues discussed in the NOSB meeting ahead could seriously undermine organic standards—unless you and other grassroots activists are willing to voice your strong objections:

How to control GMO contamination of organic seeds? Seed purity is especially important to prevent “creeping contamination.” Not only should there be stricter protocols to ensure pure organic seeds, there should be systematic testing of organic seeds for GMO contamination as part of the certification process. And biotechnology companies should be held accountable for any GMO contamination of organic seeds—even if it was unintentional. Under current organic rules, there are no strict practices ensuring that organic seeds are not contaminated with GMO. GMOs are considered an excluded “method” that should be prevented by best practices, but the actual organic product itself is not tested for GMOs. Testing usually occurs when there is “reason to believe” that organic food is contaminated with GMOs.
How to deal with GMOs in vaccines? Under current organic regulations, animal vaccines using GMOs are not allowed, unless specifically approved by the NOP. However, the NOP hasn’t identified which vaccines contain GMOs in the first place, resulting in GMO vaccine use and weak enforcement. The NOSB will discuss how to identify GMO vaccines; we believe it should it be defined as any technology that creates a targeted change or mutation in the genome; it certainly shouldn’t be something that is evaluated on a case-by case basis, another option that is being considered. We strongly oppose any GMO vaccines in organic livestock.
Should “confidential business information” (CBI) be allowed in a petitioner’s request for a synthetic chemical to be added to the organic “allowed” list? Currently, CBI is not disclosed in the technical evaluation report of a chemical, and it’s not available to the NOSB, much less to the public. But such CBI could include important information regarding environmental and health effects of a chemical. We strongly support prohibiting CBI in petitions to ensure transparency in the process—especially if the CBI pertains to serious environmental and adverse health effects. This may also have the positive effect of deterring companies that have something to hide.
Should a fruit antibiotic that adds to the “superbug” problem be allowed for two more years? The NOSB is considering whether to extend the withdrawal date for the antibiotic oxytetracycline, which is used in apple and pear production to prevent fire blight. It’s sprayed on trees, which exposes bacteria in the orchard and especially the soil to the antibiotic, and directly contributes to the “superbug” issue we’ve told you about—the creation of drug-resistant bacteria. There was a lot of public push-back against placing this on the allowed list in the first place. The board wants to extend the withdrawal date to 2016 and add a phase-out plan, even though organic standards require that practices and inputs must maintain or improve the natural resources of the operation, including soil and water quality. We do not support extending sunset date of oxytetracycline.
Should sugar beet fiber be allowed in organic food to increase overall fiber content? Most sugar beets are GE, so we oppose such a proposal, and would insist that the final product be tested for GMO. We’re also concerned that the process for adding sugar beet fiber to organic food doesn’t follow organic processes.

At the last NOSB meeting, ANH-USA strongly opposed allowing dangerous synthetic chemicals in organic food, including organic baby formula. And the board rejected most of these chemicals.

It’s important that we all participate in this process to uphold organic standards and prevent corporate interests from destroying truly organic food. Organic certification is often the only thing consumers can use to distinguish between healthy, sustainable food and industrial farmed foods, most of which contain GMOs.

Action Alert! Send your comments to the NOSB and tell them your stance on each of the agenda items above. Please send them your message today!

Dietitians Using Medicare Reform to Monopolize Hospital Nutrition Services

ANH-USA — Tue, 26 Feb 2013 22:00:00 +0000

It won’t help hospital food, already notoriously bad, to outlaw advice from the most qualified nutritionists. Action Alert! Medicare claims to be reforming some of its rules in order to get rid of unnecessary or burdensome regulations. But this has created a window for the dietetics lobby to insert language that will give them a monopoly over hospital diets. This is the very definition of a sneaky maneuver—almost no one would think to look for this change until it had already passed. Happily, we did! The Federal Register announced the various reforms to Centers for Medicare and Medicaid Services (CMS) rules earlier this month. Buried deep inside the new regulations are two sections: Food and Dietetic Services and Privileges for Registered Dietitians (RDs). This would revise the requirement that a therapeutic diet be prescribed only by the practitioners responsible for the care of the patient—a revision we agree with, since few physicians know anything about nutrition. But it would be expanded to include only Registered Dietitians (not Certified Nutrition Specialists, many with Master’s degrees and PhDs, or other highly qualified nutrition professionals) to prescribe a therapeutic diet. This rule specifically deals with special diets for patients; RDs already have a grip of iron on regular hospital food—though not by law! CMS writes—though it could very easily be the Academy of Nutrition and Dietetics (formerly the American Dietetic Association) talking—“We believe that RDs are the professionals who are best qualified to assess a patient’s nutritional status and to design and implement a nutritional treatment plan.” It adds that RDs with prescription privileges “would also be able to provide medical nutrition therapy and other nutrition services at lower costs than physicians as well [sic].” Note the co-opting of the terms “medical nutrition therapy” and “nutrition services” for RDs, even though RD’s are only required to have a college degree, and the tortured government logic that creating a new monopoly will reduce costs. The US Department of Labor places hospital diets under the control of both dietitians and nutritionists. Medicare rules should follow the same guidelines. Securing a piece of the Medicare pie is part of the dietitians’ strategy at the state level as well. Medical nutrition therapy (MNT) services are covered under Medicare part B for people with diabetes. Federal rules state that RDs or qualified nutrition professionals may provide services so long as they meet certain education and experience requirements and have been certified by a national nutrition organization. However, if an individual state has a licensure policy in place, then only the licensed individual can receive reimbursement. That is why RDs are trying to get the states to pass laws making dietitians the exclusive providers of licensed nutrition services—it creates a separate tier for themselves so they can secure MNT reimbursement through Medicare. The folks at AND/ADA are speaking out of both sides of their mouth about licensure. On one hand, they say they need a monopoly on scope-of-practice laws so they can be reimbursed by Medicaid and Medicare. But in the document that they submitted to CMS, they argue that “licensure is not a federal requirement” for dietitians to be part of a “medical staff” and therefore receive CMS reimbursement:

Licensure is not a federal requirement; it is only required for practitioners in those states with laws requiring licensure. Federal regulations specific to dietitians similarly have no independent licensure requirement. In section 482.28(a)(2) of the hospital [Conditions of Participation] defining a “qualified dietitian” in the hospital setting, “[q]ualification is determined on the basis of education, experience, specialized training, State licensure or registration when applicable, and maintaining professional standards of practice.”

Sorry, dietitians, you can’t have it both ways! Here are the monopolistic licensure bills currently in state legislatures:

Indiana: HB 1272. We recently sent special action alert to Indiana residents about this.
West Virginia: HB 2533. We will be emailing a special action alert to WV citizens soon.
New Jersey: AB 2182/ SB 833. The bills are still “alive” but in a holding pattern.
In Illinois the law is much improved. We were able to get the Illinois legislature to replace the state’s ten-year-old monopolistic dietitian law to include certified nutritionists. The new law is currently in the rule-writing phase. We will keep you updated.

Action Alert! CMS is asking for public comments on the new Medicare rule. Tell them that while we agree that hospital diets should be open to nutrition professionals and not solely under purview of physicians, we cannot support Medicare rules that create a monopoly for RDs at the expense of often better-qualified nutrition professionals. Send your message today!

Your Medical Records Are Part of a $19 Billion Experiment

ANH-USA — Tue, 26 Feb 2013 18:00:58 +0000

Fraudulent billing. Identity theft. Greater expense and inefficiency. Loss of privacy. And campaign donations from the companies benefiting most. Electronic medical records (EMR) came into mainstream consciousness after a hardcore lobbying effort by the EMR industry. The result? A $19 billion (yes, that’s billion with a B) government incentive package was built into the 2009 economic stimulus bill just for electronic medical recordkeeping. This package benefits the three largest EMR companies the most. The annual sales of Allscripts have more than doubled, going from $548 million in 2009 to $1.44 billion in 2012. Cerner’s sales increased 60% in the same period. Epic doubled its revenue to $1.2 billion from four years ago, making its founder a billionaire. That EMR companies should be so favored will come as no surprise when you learn that the then-CEO of Allscripts, Glen E. Tullman, was the health technology advisor to the Obama campaign in 2008. In 2009, before the stimulus package was finalized in 2009, he visited the president at least seven times as Allscripts CEO, and personally donated over $225,000 to the campaigns of legislators like Sen. Max Baucus (chairman of the Senate Finance Committee) and Jay D. Rockefeller (chairman of the Commerce Committee). Judith Faulkner, a controversial figure at the center of the electronic records mandate, is described by columnist Michelle Malkin as “[President] Obama’s medical information czar and a major Democratic contributor [who] just happens to be the founder and CEO of Epic Systems—a medical software company that stores nearly 40 percent of the U.S. population's health data.” In December 2008, the chief executive of an EMR trade association wrote an open letter to Obama calling for government investment of at least $25 billion to adopt EMR. The government ponied up $19 of the requested $25 billion. Despite all the government funding, EMRs haven’t lived up to the promise of lower cost and increased efficiency—something we predicted back in 2009. On the contrary, the new approach seems to be increasing costs through overbilling. Electronic recordkeeping makes it easier to overbill for services. For example, the percentage of the highest-paying claims at Baptist Hospital in Nashville climbed 82 percent in 2010—one year after it began using a software system for its emergency room records. In general, hospitals that received government incentives to adopt EMR showed a 47% rise in Medicare payments from 2006 to 2010, compared with a 32% rise at hospitals that did not receive any government incentives. Fraud is a huge problem with EMR. Some EMR programs can automatically generate detailed (but fake) patient histories, or allow doctors to cut and paste the same examination findings for multiple patients (a procedure called “cloning”) so it looks like they conducted far more examinations than they actually did. Doctors can also click a box indicating that a thorough review of patients’ symptoms had taken place, even though the exams Medicare is paying for were rarely performed. Dr. Donald W. Simborg, who was the chairman of federal panels examining the potential for fraud with electronic systems, said, “It’s like doping and bicycling. Everybody knows it’s going on.” The Office of the Inspector General is studying the link between electronic records and billing. While creating a nationwide records database might seem at first glance to be a good idea, the whole EMR policy was implemented quickly without anyone doing a careful study of potential problems. Patients and and their health records have become guinea pigs in the EMR experiment. There are many serious difficulties with EMR, even outside of the fraud issue. Doctors have complained that the system is very time-consuming and inefficient. It can actually increase rather than decrease required paperwork. They say in addition that it’s not tailored to physicians’ needs, but instead fits the more narrow vision of Washington bureaucrats. Technological glitches and human errors have, for example, resulted in the wrong prescriptions being issued. Privacy issues make it difficult to get reliable data on EMRs, but it is estimated that EMRs will be linked to at least 60,000 adverse events. There is no industry standard of liability if a patient is harmed by EMR software problems. In addition, computerized systems are vulnerable to crashes, and the larger the system, the greater the crash. Networking between EMR systems even within the same hospital system can be problematic. The internationally respected Mayo Clinic, which treats more than a million patients a year, has serious unresolved problems after working for years to get its three major electronic records systems to talk to one another, according to the New York Times. The technologies of different service providers—say, between the hospital and pharmacy—may be incompatible. Even more worrisome, the EMR system is ripe for medical identity theft, as we reported two years ago—a problem that will affect an estimated 1.49 million people in the US, at a cost of $41.3 billion. And since the healthcare system is so fractured, it often requires going from hospital to hospital to get a billing problem resolved—something that can take years. Privacy issues complicate matters further: victims and their families sometimes can’t get files from doctors to clear up the issue. Most medical facilities simply don’t have policies in place to deal with medical identity theft. Bloomberg reported the story of Arnold Salinas, a 53-year-old maintenance worker whose identity was stolen when someone took out medical care in his name. He’s been fighting his case since 2002, and fears his valid medical records will get mixed with the thief’s, possibly leading to dangerous confusion. In 2009 we were promised that the EMR system would “cut waste, eliminate red tape and reduce the need to repeat expensive medical tests...it just won’t save billions of dollars and thousands of jobs; it will save lives by reducing...medical errors.” None of those promises have come true. The government, pushed by special interests, has rushed through an EMR system that costs American taxpayers more and makes our medical records—and possibly our health—far more vulnerable. As we noted in 2011, allowing hundreds of thousands of parties to access your records, including mental health and other sensitive information, is by definition a serious invasion of privacy. When you apply for a government job, they ask you if you have seen a psychiatrist in the last five years. People who need help may be reluctant to seek it with their records available to the whole world. If everyone’s records are open for others to see, who will confide to their doctor anymore?

Court to Farmers: “You Don’t Have the Right to Fight the USDA!”

ANH-USA — Tue, 26 Feb 2013 17:00:46 +0000

Once again it’s government and industry on one side, and organic farmers on the other. Action Alert! Last Friday, the DC Court of Appeals held that California almond producers don’t currently have the right to even argue that the USDA overstepped the bounds of its authority with the Almond Rule. The USDA’s Almond Rule, issued in 2007, ordered all almond growers to “sterilize” almonds in one of several ways: heat them using steam, oil roast or blanch them, or treat them with propylene oxide (PPO). As we told you at the time and again last year, these are all poor options:

Roasting and blanching completely cook the nuts, so they are no longer raw.
Steam reduces nutrient content and also cooks the nuts.
PPO, a “probable human carcinogen,” is an extremely volatile liquid now used in the production of polyurethane plastics, and once used as a racing fuel until it was banned for being too dangerous.

Almond producers argue that labeling such almonds “raw” is therefore misleading—they are actually cooked or chemically treated. They want to argue that the Almond Rule oversteps the USDA’s authority—but the court ruled the almond producers lost the right to make that argument because they didn’t raise their concerns during the rule-making process. However, the rule-making process in itself was unfair and legally questionable. The USDA handpicked 115 almond growers and handlers—out of over 6,000—to invite them to comment, and consumers and retailers were almost universally unaware of the proposed rule. Because of this, there were a total of only eighteen public comments. During the rule-making process, the USDA merely regurgitated the findings of the Almond Board, a biased and financially motivated stakeholder. The rule-making process is supposed to be conducted by an unbiased decision-maker without any financial interests, but six out of the ten seats on the Almond Board are controlled by Blue Diamond, an enormous almond producer. The interests of small, organic almond farmers weren’t even considered. The Almond Rule isn’t just about almonds. The rule actually expands the USDA’s powers, allowing the agency to mandate how dairy, fruit, vegetables, nuts, and animals are processed—something they have never been able to do. The USDA is legally allowed to establish minimum standards for farm products based on grade, size, or quality; they can say, for example, that “Almonds must be free of salmonella.” But the Almond Rule changed all that, allowing USDA to claim it can mandate how that outcome is achieved (e.g., “Almonds must be made salmonella-free via one of the following pasteurization processes…”). If this newly asserted authority is upheld, it could be the USDA’s latest weapon in the war against raw foods. Instead of saying that milk needs to be pasteurized, it can now dictate the way it is pasteurized. This sort of authority favors ideological zeal over real scientific evidence, as we saw with the CDC’s deeply flawed study on raw milk, or the more recent (but equally flawed) raw cheese study. If the government is this enthusiastic about shielding consumers from the extremely small risk from raw almonds, why can’t they get excited about protecting us from untested GMOs or the larger, nearly annual salmonella outbreaks from ground beef? (USDA, take note: “more processed” doesn’t necessarily mean “safer”!) We may have lost this battle, but not necessarily the war. The DC Court of Appeals sidestepped the issue and didn’t rule on the legality of the Almond Rule itself, just said that almond farmers “missed the boat” on expressing their reservations by not raising objections during the rule-making process, although that was done as much behind-closed-doors as USDA could make it. For further litigation, a producer must convince the court that it has actually been harmed, or some brave company must defy the USDA and after being enjoined to stop and take the agency to court. If any of this happens, the producers can go back to court and spend money and time all over again. ANH-USA will be conferring with friends and colleagues about how to try to make this happen. Action Alert! In the meantime, we should all voice our complaint to the USDA about its high-handed tactics and absurd Almond Rule and, importantly, send a copy to Congress. Please send your message today!

Wireless Smart Meter Opt-Out in Maryland

ANH-USA — Wed, 20 Feb 2013 16:18:52 +0000

Utilities across America are moving forward with the installation of wireless smart meters. These smart meters emit pulsed radio frequency radiation that, according to many reports, can damage people’s health and leave residents’ meters vulnerable to malicious attacks from hackers. Take action and support HB 1038, a bill that would require homeowner notice before Smart Meters are installed.

Click Here to TAKE ACTION

Support SB55! Prevent Employer-Mandated Flu Shots in Connecticut

ANH-USA — Wed, 20 Feb 2013 15:16:28 +0000

Please support SB55, a bill that would prevent employers from mandating that their employees receive flu vaccines as a condition of their employment. The US flu shot still contains mercury, which among other things is associated with the development of Alzheimer’s. And a recent study indicates that people who received a flu shot were more likely to become infected with the H1N1 flu virus than people who haven’t received the shot. Residents of Connecticut should not be forced to receive an ineffective and potentially dangerous medical procedure.

Click Here to Take Action

Compact Fluorescent Light Bulbs: A New Cancer Risk in Your Home

ANH-USA — Tue, 19 Feb 2013 20:00:28 +0000

Have the government and General Electric lied to us? Action Alert! The Energy Independence and Security Act of 2007 (EISA) mandates the phase-out of incandescent light bulbs, and favors energy-efficient compact fluorescent light (CFL) bulbs. Sounds good—until you realize that CFL bulbs contain mercury, and mercury poses a significant cancer risk. A new study shows that CFL bulbs also emit high levels of ultraviolet radiation—specifically, UVC and UVA rays. In fact, the UV rays are so strong that they can actually burn skin and skin cells. Experts say the radiation could initiate cell death and cause skin cancer in its deadliest form—melanoma. In every bulb the researchers tested, they found that the protective phosphor coating of the light bulb was cracked, allowing dangerous UV rays to escape. Healthy skin cells exposed to CFLs showed a decrease in their proliferation rate, an increase in the production of reactive oxygen species, and a decrease in ability to contract collagen. On top of that, it’s a sad fact of life that light bulbs break. How do you clean up the mercury after a bulb breaks? The Institute for Molecular and Nanoscale Innovation measured the release of mercury vapor from broken bulbs. They recorded concentrations near the bulb of up to 800 mcg/m³, which is eight times the average eight-hour occupational exposure limit allowed by OSHA (100 mcg/m³). Even more shocking, the recommended limit for children is a mere 0.2 mcg/m³. A child exposed to a broken CFL bulb will receive eight thousand times the recommended amount of mercury vapor! A broken 13-watt CFL bulb will only have released 30% of its mercury a full four days after it is broken—the remainder is trapped in the bulb. So picking up shards with your bare hands or leaving them in poorly ventilated room while you ponder the best disposal method is a particularly bad idea. Unfortunately, there is no good solution for cleaning up after a broken CFL bulb. Researchers at Brown are testing a cloth made with a nanomaterial (nanoselim) that can capture mercury emissions for proper disposal. But until this is commercially available, it is best to avoid CFLs altogether. And how will we dispose of the clean-up cloth? General Electric claims that CFLs don’t produce a hazardous amount of UV radiation, and that UV is far less than the amount produced by natural daylight. The truth is that all compact fluorescent lights bulbs contain mercury vapor. Once that vapor is hit with an electric current, it emits a great number of UV rays. UV rays are theoretically absorbed by the layer of phosphor that coats the bulbs—but the signature twisted spiral shape makes these bulbs more prone to cracks in the phosphor, which dramatically increases UV/mercury exposure. Researchers found cracks in almost all bulbs purchased from retail stores, indicating that it is a standard design flaw of these bulbs. CFL bulbs contains other cancer-causing chemicals as well. German scientists found that several different chemicals and toxins were released when CFLs are turned on, including naphthalene (which has been linked to cancer in animals) and styrene (which has been declared “a likely human carcinogen”). A sort of electrical smog develops around these lamps, which could be dangerous. CFLs are supposedly better for the environment, but according to the Association of Lighting and Mercury Recyclers, 98% of CFLs end up in landfills—creating a mercury build-up that can escape into our soil and waterways. We’re happy that the federal government is tackling environmental problems, but this “solution” is especially short-sighted—and not unlike the national smart meter push, is creating serious health risks in the long-term. Worse, soon consumers won’t have the option to buy incandescent lights—they simply won’t be available. The government hasn’t placed an outright ban on incandescent light bulbs. Section 321 of EISA mandates higher efficiency standards for general service lamps. But these standards are high enough that most commonly used incandescent bulbs just won’t meet the new requirements. EISA will effectively eliminate 40-, 60-, 75-, and 100-watt incandescent bulbs. The new efficiency levels will be in full force by 2014. Even the United Nations has acknowledged the problem of mercury in CFL bulbs, and has instated a ban on certain types of CFLs. We won’t know the full implications of that ban until the treaty is made publically available. The good news is that CFLs are not the only energy-efficient bulbs out there. There are also light-emitting diodes (LEDs), which are mercury-free—though LEDs emit blue light, which can be disruptive to sleep, as we noted in our 2012 article. Action Alert! Please contact your legislators immediately and call for a repeal of the ban on incandescent lights. Tell them about the cancer risks and the lack of proper disposal methods. Please take action today!

Director of Public Affairs

ANH-USA — Tue, 19 Feb 2013 19:10:06 +0000

Responsibilities The Director of Public Affairs’ job duties may include: Fundraising and Development (60%) The primary function of the Director of Public Affairs will be to build and maintain personal relationships with a roster of major donors, in order to secure large gifts ($5,000+). As the Director will have considerable input into the expansion and direction of our major donor program, this position is perfect for an ambitious fundraiser seeking to grow professionally.

Envisioning and implementing innovative ways to grow our donor program
Expanding prospect pipeline and funding base by accessing new networks and leveraging existing ones
Identifying, cultivating, and securing five- and six-figure gifts from individual, corporate, and foundation donors
Developing weekly reports and preparing monthly briefings to the Executive Director on the status of contacts, solicitations, and proposals
Effectively communicating organizational mission, vision, and strategy to ensure donors are aligned, inspired, and engaged
Accurately and positively representing the organization to donors, decision makers, and members of the public
Attending trade shows, conferences, and other events to network with influential persons, potential donors, and existing donors
Coordinating fundraising efforts with the Membership Director
Acting as a liaison between major donors and organizational staff to ensure staff are aware of donor concerns

Advocacy, Research, and Communications (40%)

Ad-hoc research to support the work of the Executive Director
Working with the Campaigns and Communications Director in the development and promulgation of a policy agenda
Establishing relationships and working with legislators and their staff to develop, amend, pass, withdraw, and defeat bills as appropriate, including crafting language for legislation, drafting comments on administrative regulations, and authoring policy briefs

Representing and advocating for ANH-USA and its constituents with federal and state elected and agency officials
Identifying, tracking, and monitoring the movement of key legislation and policy proposals that may impact the natural health and health freedom communities
Assisting the Executive Director in developing research-informed positions that ANH-USA may take on policy and legislation, making specific recommendations that seek legislative and/or administrative action at state, local, and/or federal levels
Supporting the Executive Director in the operation of a functional and productive office and work on various projects as needed

A successful applicant should have:

A history of successfully raising money for politically active non-profits from multiple sources (e.g., individual donors, foundations, and corporations)
Recent experience personally soliciting five- or six-figure gifts
Proven success building a portfolio of donors from scratch
Excellent communication skills with an emphasis on brevity, persuasiveness, and the ability to relate to a number of politically diverse constituencies and audiences
Passion, energy, and the ability to command the respect of donors
Personal interest in natural health is essential
Willingness to travel by airplane for 3 to 5 days per month on average
The ability to work independently with initiative and efficiency

Preference will be given to candidates who have these desirable, but not required, assets:

3 to 5 years of experience
Pre-existing connections to influential persons and/or potential donors in the natural health and integrative medicine community
Proven success in increasing the visibility of a small organization
Experience personally closing five- or six-figure gifts
Experience with Convio CMS
Experience with a small organization undergoing rapid growth

eTo apply, please submit a brief cover letter and resume to Liz@ANH-USA.org. Be sure to include “Director of Public Affairs” in your subject line. Cover letter must include salary requirements. Please do not call the office.

Why Bloomberg Is All Wrong about Vaccines

ANH-USA — Tue, 19 Feb 2013 18:00:31 +0000

We don’t need more crony capitalist solutions. In the Bloomberg.com editorial, “Got the Flu? The Market Can Fix That” (Jan. 22), the writer says that vaccines are the only game in town for controlling the flu and concludes: “Making a new vaccine typically takes a decade and can cost $1 billion. A project of that size is better suited to large pharmaceutical companies....Given this market reality, the US government should design incentives to get the industry more deeply involved.” This sounds sensible until you consider what it actually means. Do we really want a world in which the government envisions a vaccine, helps develop it, subsidizes it, then evaluates its effectiveness and safety, and finally mandates it for children? How objective can we expect the government to be in evaluating, approving, and mandating its own product? We don’t mean to quibble, but we also want to know how the writer can describe this as a market solution. What kind of Orwellian language is this? What is actually being recommended is a government solution working through Big Pharma companies, which is a formula for crony capitalism. If this system leads to out-of-control costs in defense procurement, it is bad enough. If it goes awry in matters pertaining to our children’s health, that is even more serious. A quick glance at the number of FDA-approved drugs recalled each year because they are later found to be dangerous is shocking. Let’s not make that worse by having the government approve and mandate what are essentially its own products. The editorial is also too quick to accept widely accepted “facts” that are not facts at all. It begins with: “Influenza…each year kills as many as a half-million people, including 3,000 to 49,000 Americans.” It is true that, as Bloomberg reported in 2010, the CDC estimates the annual toll to be 23,607. But these figures are actually a fabrication: the CDC has used a mathematical estimate based on the assumption that if a death certificate had “respiratory or circulatory disease” listed as a cause of death, then it should be counted as a “flu-related” death. The Journal of American Physicians and Surgeons has been highly critical of the CDC’s methodology. Data from the National Center for Health Statistics (NCHS) show an average of 1,348 actual flu deaths per year—a mere 5.7% of the CDC’s estimate. In fact, 2010 showed only 500 deaths directly attributable to flu. Nor are flu vaccines “the best weapons we’ve got,” as the editorial states. There are currently three different “epidemics” hitting the US: “true” influenza (type A, type B, or seasonal H1N1 influenza), norovirus (“stomach flu”), and whooping cough. According to a meta-analysis published in the weekly peer-reviewed medical journal The Lancet, only 2.7% of non-vaccinated adults caught the flu, which means that 97.3% of them did not. Among vaccinated adults, 1.2% caught the flu. This means the big national vaccine drive will possibly keep 1.5 people out of 100 from catching the flu. In addition, there is no evidence that the flu vaccine provides any protection whatsoever for adults 65 and over—even though the elderly are one of the flu vaccine campaign’s target populations, and USA Today reports that so far this flu season, people over 65 are dying from a laboratory-confirmed case of influenza at a rate of 116 per 100,000. There is also some evidence that the vaccine itself poses health risks. In Canada, researchers found that people who got a flu shot were more likely to get infected with the H1N1 pandemic virus than people who hadn’t received a flu shot—and this has since been verified in animal studies. In addition, the US flu shot usually contains thimerosal, an organomercury compound used as a preservative. Mercury is highly toxic and there is worry that this form of it might be linked to developmental disabilities and abnormalities in the brain similar to those in autistic patients. There are also questions about a possible link to Alzheimer’s. Mercury has been removed from most US vaccines; flu is the exception. Europe does not allow it in any vaccines. Why do we? Given the uncertain effectiveness and safety questions, it might be better to skip the flu shot, build up your immunity instead with vitamin D3 (there is now a great deal of scientific research supporting this), and if you become infected, take vitamin A (real A, not beta carotene; Dr. Wright recommends 25,000 IU of vitamin A per day). Or use it in conjunction with other tried-and-true natural remedies. Why aren’t the FDA and the medical establishment interested in these natural preventives and cures? As all of us at ANH know, the problem is a bureaucratic “Catch-22” that is blocking better, safer, preventive and life-saving treatments. All drugs must be FDA-approved. If a substance has not been declared an FDA-approved drug, no health claims may be made about it, regardless of the scientific backing for the claim. But, as noted in the editorial, taking a product through the FDA drug approval process is extraordinarily expensive. Natural substances generally cannot be patented. Without the protection of a patent, and the extremely high prices that a patent would allow a company to charge, the manufacturer could never hope to make back its investment. Consequently natural products and research languish, with no hope of ever being able to say that anything prevents or treats the flu. No wonder everyone thinks that vaccines are the only way to prevent the flu. Nothing else can get FDA approval—for purely financial reasons! All of this defies common sense. And it is not just a problem for treating the flu. The same problem exists in cancer research and other medical fields. Bloomberg is a company that has thrived by selling information to Wall Street. Wall Street has had plenty of money to buy Bloomberg terminals because it gets to distribute masses of new money just printed by the government’s Federal Reserve. Michael Bloomberg, the company’s founder, has used his fortune to win three terms as mayor of New York, despite a two-term limit when he started, and has also used his vast fortune in other ways to win friends and influence people. It is not entirely surprising therefore that Bloomberg recommends a crony capitalist approach to beating the flu epidemic. But no, we don’t need an even deeper government–Big Pharma partnership. That is exactly what we don’t need.

Forbes Calls for “Re-institutionalizing” the Mentally Ill

ANH-USA — Mon, 18 Feb 2013 19:00:13 +0000

Will that avoid mass shootings like Sandy Hook—or just put people on the very drugs that can make them homicidal? In the January 21 issue of Forbes magazine, Steve Forbes says that hundreds of thousands of people lead tortured, miserable lives and need supervised care. His solution is to repopulate public mental hospitals and wards instead of emptying them, as we have done. The problem, of course, is that mainstream treatment usually means a battery of antidepressant and antipsychotic drugs and these drugs can make people suicidal and homicidal—the very problem we as a society are trying to prevent. It’s no secret that the medical psychiatric and the pharmaceutical industry are riddled with conflicts of interest—at the expense of the patients themselves. Nearly 70% of the taskforce members who have been busy creating the DSM-5 (the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders, essentially the Bible of clinicians, researchers, psychiatric drug regulation agencies, health insurance companies, pharmaceutical companies, and policy-makers) reported financial relationships with pharmaceutical companies, up from 57% for the DSM-IV. In the DSM-5, the definition of depression has been expanded to include bereavement—a change that could give drug companies a potential $10 billion increase in antidepressant sales. SSRI antidepressants (selective serotonin reuptake inhibitors) are known to be addictive and hard to get off of, so using them to alleviate normal human suffering is not a good idea. They are also among the most frequently prescribed drugs for children with autism—even though there is no evidence that these drugs help in the least. As we reported previously, SSRIs as treatment for depression can create either suicidal thoughts or outbursts of irrational violence against others; this side effect is seen both when taking the drug and when withdrawing from it. Granted, this is association and not necessarily causation—but it raises enough red flags that one must proceed cautiously:

Steven Kazmierczak, who shot five people and wounded twenty-one others, was taking a cocktail of three different prescribed psychiatric drugs, including Prozac and Xanax.
Jeff Weise, who shot and killed his grandparents before going to his school and killing seven students and a teacher, wounding seven others, then killing himself, was on Prozac.
Jason Hoffman, who was taking the antidepressants Celexa and Effexor, opened fire on his classmates, wounding three students and two teachers.
Eric Harris and Dylan Klebold killed twelve students and a teacher and wounded twenty-six others before killing themselves. Harris was on the antidepressant Luvox.
Kip Kinkel, who murdered his parents, then at school killed two and wounded twenty-five, had just gone off Prozac.
Adam Lanza, the Sandy Hook shooter, was “on medication.” ABC News said he had “mental illness” and a “personality disorder”—the very conditions that would lead one to be treated with psychiatric drugs.

Steve Forbes writes, “No one would assert that more proactive treatment of people with extremely serious mental ailments would prevent all mass killings. But the growth in the number of such massacres since the 1960s, when the deinstitutionalizing movement got under way, makes clear that these horrific occurrences could be sharply reduced.” We would point out that the first major mass shooting wasn’t until 1966, and the shooter, Charles Whitman, had never been institutionalized, much less deinstitutionalized. SSRIs were developed in the 1970s, and in the 1980s began replacing the older tricyclic antidepressants we told you about last week. The number of mass shootings started increasing dramatically as with the popularity of SSRI drugs increased. Since 1982, there have been at least 62 mass shootings across the country; 25 of them have occurred since 2006, and seven of them took place in 2012. We are not arguing that violent or seriously ill people should not be confined to mental hospitals—merely that to blame the whole problem on deinstitutionalization is to ignore the fact that the drugs that are supposed to be helping these young people may in fact be responsible for their violent outbreaks. Institutionalization will make it easier to force these drugs on people and giving them in hospitals doesn’t make them any safer. SSRIs, tricyclics like amitriptyline, and other antidepressants are now firmly established as being linked to the danger of suicide: FDA has a black box warning for young people (though of course it should be for all people). FDA said they were looking into SSRIs and the risk of violence to others after we petitioned them for a black box warning about it, but the agency still hasn’t issued a final decision. Nor is it likely to, because admitting this would ravage sales and hurt the bottom lines of the drug companies. Forbes has had a history of hostility toward natural therapies. The magazine often promotes a mainstream medical view and has been openly suspicious of supplements—likely because of their ties to drug companies. However, there may be hope for Forbes yet. In the past two years the magazine has lauded, interviewed, and discussed in numerous articles fitness guru and entrepreneur Tim Ferriss, author of The 4-Hour Chef and The 4-Hour Body, who recommends a number of supplements. This is likely the first time supplements have been treated with anything but contempt at Forbes. Perhaps they are finally becoming aware of all the exciting new science around supplements. As any integrative physician can tell you, nutritional deficiencies and imbalances can cause depression. Dr. Jonathan Wright suggests an amino acid supplement program to boost levels of mood-regulating neurotransmitters in the brain without the side effects of prescription drugs. One can get a blood test that assesses fasting levels of essential amino acids; if levels are low, it is important to use blend of all eight essential amino acids. However, it’s important to look for the cause of low amino acid levels. Quite often it’s because of low stomach acid (hypchlorhydria); if this is the case, patients can benefit from supplemental acid and other supplements. Dr. Mark Hyman has stated that “Depression is not a Prozac deficiency,” noting that it is often caused by biological imbalances resulting from nutritional deficiencies and exposure to environmental pollutants—and not necessarily chemical imbalances. Besides taking supplements like St. John’s Wort, tryptophan (but not with St John’s Wort), SAMe, vitamin D, DHEA, B vitamins such as niacin, B-12 and folate, and adrenal gland boosters, other treatments for depression include a change in diet, getting enough sleep, getting enough exercise, getting enough light, and finding a useful purpose for your life bigger than yourself. Many people have found relief through homeopathy or acupuncture (often accompanied by a custom Chinese herbal formula). For more severe depression, one might consider hyperbaric oxygen therapy (HBOT). In Dr. Paul G. Harch’s study of veterans with depression after traumatic brain injury, 93% of them saw improvement after HBOT. Anxiety is greatly relieved by L-theanine and especially by the more bioavailable forms of GABA (this is important because not all of them work). Even psychotic conditions can benefit from natural approaches but require supervision by a skilled integrative physician. We must get away from mainstream medicine’s insistence on treating depression and other mental illnesses with drugs that have dangerous side effects for the patient and for society. Confinement in mental hospitals may hurt rather than help the problem without understanding this fundamental point.

A Natural, Inexpensive, Easily Accessible, Safer Treatment for Depression?

ANH-USA — Tue, 12 Feb 2013 22:00:21 +0000

Not if pharmacists have their way! Action Alert! Pharmacists Planning Service (PPS), a “public health, consumer, and pharmacy education” nonprofit, is petitioning the FDA to change the designation of St. John’s Wort from “herbal dietary supplement status” to “behind pharmacy counter status” (BPCS)—a designation that requires pharmacist consultation—citing dangerous side effects and drug interactions. PPS’s claim is specious. St. John’s Wort (Hypericum perforatum) is far safer than prescription depression medications. Unlike those medications, it has not been linked to addiction, suicide, or violent behavior. It also appears to be effective and has been used for many years in Germany and other countries to treat mild depression, especially in children and adolescents. A meta-analysis found that “the hypericum extracts tested in the included trials a) are superior to placebo in patients with major depression; b) are similarly effective as standard antidepressants; c) and have fewer side effects than standard antidepressants.” The “fewer side effects” issue is an important one. A 2000 study found that SJW “was superior to fluoxetine [Prozac] in overall incidence of side-effects, number of patients with side effects, and the type of side effect reported.” Similar studies found SJW superior to other SSRIs (selective serotonin reuptake inhibitors) as well. This actually understates the side effects risk issue for adolescents and young people. Black box warnings on SSRI’s warn of suicide risk for these groups; they should warn of violent behavior risk but do not. The FDA does not want to admit the evidence linking the drugs to violent behavior, including mass shootings. Another, older class of antidepressants is TCAs (tricyclic antidepressants), which, according to a study from early 2011, are at least as effective against depression as SSRIs (this is faint praise, since SSRI’s have not been proven to be very effective). Although TCAs are slowly being replaced by SSRIs, they are still extremely popular: according to Pharmacy Times, in 2011 the most commonly prescribed drug in the US was a TCA called amitriptyline (sold under the trade names Tryptomer, Elavil, Tryptizol, Laroxyl, Saroten, Sarotex, Lentizol, and Endep). Amitriptyline’s side effects range from anxiety, panic attacks, chest pain, sudden numbness to one side of the body, sudden severe headache, and problems with vision, speech, or balance, to suicidal ideation, hallucinations, seizures, and bleeding from the nose, mouth, vagina, or rectum. Antidepressant drugs of all kinds are huge money-makers for drug companies: Antidepressants are used by 11% of Americans. Use has increased 400% over ten years. And, of those taking them, 60% report using for more than two years. Seven of the top eighteen prescribed drugs are antidepressants. Because it is safe, effective, and relatively inexpensive, SJW poses serious competition to the US pharmaceutical industry. The thought of more and more people turning to an over-the-counter herb instead of relying on pharmaceutical drugs has pharmacists running scared. In addition, there is currently an oversupply of pharmacists, which has had the effect of reducing pharmacists’ wages by 20% on a national scale. This oversupply will only continue as e-prescribing increases, the pharmacy technician’s role is expanded, and pharmacy benefit managers restrict distribution channels and force patients into the mail-order system. This would seem to be a case where PPS does not really have consumers’ interests in mind, but instead are trying to protect their own bottom line from competition. We do not know the exact percentage of prescriptions that are filled by pharmacists (as opposed to pharmacy technicians), though certainly the majority are. We do, however, know that prescription antidepressants were the second most frequently dispensed prescriptions in the US in 2010 (they were beaten out by statin drugs and other lipid regulators), with over 253.6 million antidepressant prescriptions filled. SJW is direct competition because it doesn’t require prescription, and therefore doesn’t require a visit to the pharmacy for access. The math is simple: higher SJW sales means fewer antidepressant prescriptions, which means fewer prescriptions for pharmacists to fill, which means fewer pharmacists employed. If PPS is successful in its petition, St. John’s Wort will no longer be an easily accessible alternative to prescription drugs. PPS has a history of putting pharmacists between consumers and even over-the-counter products as much as possible—for example, the organization advocates mandatory pharmacist/consumer consultations and patient history checks. Let’s look further at PPS’s claim that SJW is unsafe. According to NIH’s National Center for Complementary and Alternative Medicine (NCCAM), SJW’s potential side effects are mild; they include dry mouth, dizziness, gastrointestinal symptoms, and an increased sensitivity to sunlight. PPS claims that SJW caused one death through an interaction with cyclosporine. However, the author of the article PPS quoted as evidence was unable to provide us with an accurate citation after we reached out to him. FDA does not have this death on file. The petition mentions that two recently approved hepatitis C drugs contain a SJW drug interaction warning in their package inserts, and notes that SJW should be avoided if the patient is taking certain other drugs. But since 2000 the American Herbal Products Association (AHPA) has had in place a guidance policy recommending that SJW products be labeled with a warning not to take SJW while taking any prescription drugs without the advice of the prescribing physician. In other words, PPS is simply acknowledging what the supplement industry has known for many years: some St. John’s Wort ingredients can interact with certain drugs—information that is already disclosed through the broad use of the warning label. SJW should not be placed behind the counter. Not only is it a safer alternative to prescription antidepressants—and there are very few treatments for mild depression on the market at all—but making its purchase contingent on a consultation with a pharmacist also places one more hurdle between consumer and natural treatments. Such a move might dissuade the consumer from taking SJW (which is, of course, PPS’s hope). It would also give a false impression of that SJW is dangerous. The very idea that pharmacists are in a position to counsel on the use of SJW is ridiculous. Quite apart from the conflict of interest, pharmacists in the US, unlike in Germany, know nothing about herbs. They are in no way qualified to give advice on the subject. We wish that pharmacists were qualified to give advice on herbs and other supplements. We also wish that so-called drug stores were healthy places that did not make almost all their money from a combination of junk food and drugs. In this respect, these stores are emblematic of what is wrong with American health: first create a problem with poor diet and then mask the problem with prescription drugs that control symptoms, do not cure, and may be highly toxic themselves. This is one money-making machine we do not need. There is no specific timeline for this petition: FDA has not yet responded to PPS’s petition, and it is still open for public comment. Action Alert! Please tell FDA that St. John’s Wort is a safe and time-tested remedy for mild depression, that the safeguards already built into the system with the warning on the label are completely adequate, and that druggists do not have the qualifications to play any such advisory role. No reclassification to “behind the counter status” is even remotely warranted. Please write to the FDA today!

2/13/2013: An earlier version of this article stated that TCAs are a newer class of antidepressants than SSRIs. TCAs are actually older, which the article has been edited to reflect.

“Big Farma” Still Trying to Hide Their Dirty Secrets

ANH-USA — Tue, 12 Feb 2013 18:00:59 +0000

Five states have introduced seven different “Ag-Gag bills” to silence people who try to expose CAFO practices. State-based Action Alerts! Remember our exposé on the factory farms, and the legislation designed to keep the public in the dark about them? They’re back! It’s not just that these bills trample the First Amendment. It’s that these bills are designed to keep the filthy, profoundly unsanitary conditions at factory farms—CAFOs, or Confined Animal Feeding Operations—from being exposed to the public. CAFOs are the antithesis of safe and nutritious food. If governments, both federal and state, were truly serious about food safety, they would address the miserable CAFO conditions. CAFOs are responsible for foodborne illnesses such as salmonella and listeria; are notorious for their use of antibiotics for nontherapeutic uses, and for exacerbating the “superbug” problem in which organisms become increasingly resistant to antibiotics; and ruin rural economies. In addition, there is the inhumane treatment of the animals themselves. Ag-Gag laws prevent consumers from being informed, and therefore consumers ability to fully choose what they eat. The current spate of bills are not novel: ten states introduced similar legislation in 2011–12, and bills were passed in Iowa, Missouri, and Utah. The rest were defeated by grassroots activists like you. These bills are introduced by legislators who have strong industry financial backing. Industry has the tenacity—and the deep pockets—necessary to keep trying to push these bills through again and again, year after year, if they don’t pass the first time. Last year’s bill in Iowa is a good case in point: it’s a study in rampant conflicts of interest. Monsanto pushed Iowa’s anti-trespassing/Ag-Gag bill because the company has more facilities in Iowa than any other state in the country, and because “crop operations” are also covered by the bills—so Monsanto seed houses, pesticide manufacturing plants, and research facilities in Iowa will be “protected” from hidden cameras or whistleblowers infiltrating their plants. It’s really all about the economics of CAFOs:

There are approximately 15,000 CAFOs in the US, which raise 50% of all animals used for our food.
The largest food processors hold the greatest share of the market, so they wield more power, both economic and political.
CAFOs receive a wide array of subsidies, both direct and indirect, such as crop subsidies on the corn and soybean used to feed CAFO animals. This in turn means more money in the pockets of feed producers like Monsanto.
Because CAFOs are not held accountable for the environmental and health damage they do, they don’t have to worry about those costs, putting more into their pocket. Those costs are absorbed by the public at large.
There are also the economies of scale: once a farm is automated for a large number of animals, doubling that number does not mean a doubling of costs. Organic costs more to produce—as much as 20% more—than CAFOs and factory farms because they require more labor (no use of dangerous of chemicals), more costly fertilizer, higher labor costs for crop rotation, more money spent on organic certification, slower growing time, greater post-harvest handling costs to avoid cross-contamination, and more spacious (and thus more expensive) living conditions for livestock. And of course they don’t receive the aforementioned subsidies.

Sponsors of the 2012 Iowa bill, Senators Joe Seng (D) and Annette Sweeney (R), received contributions from special interests including the Iowa Corn Growers Association (who contributed 8% of Seng’s campaign funding and gave a similar amount to Sweeney), the Iowa Farm Bureau Association, Monsanto, and the Iowa Agribusiness Association. Of course we have no idea what lobbying, if any, went on behind closed doors, but the money trail—and the support for legislation that directly benefits these special interests—speak for themselves. These Ag-Gag laws are inspired by a model bill called the “Animal and Ecological Animal Terrorism Act” from the American Legislative Exchange Council (ALEC). ALEC has both powerful corporate members and legislators, making the conflict of interest pretty seamless. ALEC’s corporate members are a Who’s Who of the Big Food supply chain, from farmers to retailers: Monsanto, Kraft, Walmart, Walgreens, etc. The intent of the ALEC-modeled bills is to introduce them in many states, sometimes word-for-word. It becomes a systematized process. As the New York Times reported last year, an ALEC membership brochure “boasted that ALEC lawmakers typically introduced more than 1,000 bills based on model legislation each year and passed about 17 percent of them.” When ALEC runs with a bill, it has the support necessary to go much further by being introduced in many states simultaneously. It's a sneaky way of legitimizing an idea that benefits only powerful and wealthy companies, not the general public. Numerous state legislators are members of ALEC; last year, of the sixty legislators who voted in favor of Ag-Gag bills, 23% of them were members of ALEC, as are sponsors of three of the new Ag-Gag bills: Arizona state senator Jeremy Hutchinson and Wyoming state representative Sue Wallis. In 2010 Wallis was the subject of a conflict-of-interest complaint for trying to block legislation that would send stray horses to slaughter when at the same time she was planning to build a horse slaughter plant of her own. Both Wallis and her cosponsor on the Wyoming bill, Ogden Driskill, are both members of Wyoming Stock Growers Association. Driskill accepted contributions from livestock industry as well as Exxon Mobil. Here’s a run-down of all seven state bills:

State	Bill Number	Description
Arkansas	SB 13	Makes an “improper animal investigation” by someone who is not a “certified law enforcement officer” a misdemeanor with a potential civil penalty of $5,000.
Arkansas	SB 14	Makes “interference with livestock or poultry” a misdemeanor. “Interference” is defined as creating a concealed image or sound recording or by applying for employment as part of an undercover investigation.
Indiana	SB 373	Makes it unlawful to record agricultural or industrial operations, whether by photograph, film, or video.
Indiana	SB 391	Requires the Indiana Board of Animal Health to maintain a registry of persons convicted of recording such operations.
Nebraska	LB 204	If a person makes a "false statement" in an employment agreement with the intention of doing an animal facility “economic harm” or doing “serious bodily injury” to someone, criminal violations kick in. If the economic damages are more than $100,000, or there is serious bodily injury, felony charges can be brought. A more serious felony can be brought if economic damages exceed $1 million or if the violation involves the death of another individuals. The bill specifically says that it is not intended to prohibit otherwise lawful, peaceful picketing or to restrict other rights under the First Amendment. Employees who believe animals are neglected or mistreated must make their report within 24 hours of its discovery.
New Hampshire	HB 110	Requires that anyone who records cruelty to livestock must report it within 24 hours.
Wyoming	HB 0126	Makes “knowingly or intentionally” recording the image or sound from an agricultural operation without the consent of the owner or manager is a misdemeanor punishable for up to six months in jail and a $750 fine. Also requires reporting animal abuse within 48 hours, and anyone who makes a good faith effort is immune from civil liability for making a report.

Action Alert! CAFOs don’t need further protection, and individuals who bravely expose CAFO conditions should not be penalized. If you’re a resident in one of the five states where these new bills have been offered, please contact your legislators and tell them to honor free speech and oppose these bills. Please send your message today!

Arkansas residents

Take Action

Indiana residents

Take Action

Nebraska residents

Take Action

New Hampshire residents

Take Action

Wyoming residents

Take Action

Fight for Vaccine Free Choice in Your State!

ANH-USA — Mon, 11 Feb 2013 17:02:40 +0000

There has been a recent spate of bills in state legislatures concerning vaccine rights. If you live in New Jersey, New York, Oregon, Texas, Vermont, or Virginia, tell your representatives that vaccine free choice is important to you and your family. Act now!

New Jersey Residents - Tell your Legislators to Support Vaccine Free Choice!

Three bills before the New Jersey legislature deal with vaccine rights. A1368 would allow conscientious exemptions to mandatory immunizations (a conscientious exemption is defined as a “sincerely held or moral objection” to vaccination). A920 would exempt a child under age 6 from receiving the hepatitis B vaccine if the child’s mother tested negative for hepatitis B during her pregnancy. Tell your legislators to support both of these excellent bills. S1759 would restrict the religious exemption for vaccines: it would require a doctor’s note plus a sworn affidavit that it is a “bona fide” religious belief. Tell your legislators to oppose this bill, as states should not interfere in personal choices and beliefs when it comes to vaccines.

New York Residents - Tell your Legislators to Support Vaccine Free Choice!

Two bills before the New York legislature deal with vaccine rights. A20267 adds the human papillomavirus (HPV) vaccine to the list of vaccines required for school, despite the fact that its actual effectiveness is unknown—at best it may protect against only two of the fifteen cancer-causing strains of the virus—and the side effects and reactions from the vaccine are sometimes severe.

AB497 allows minors to consent to receiving the HPV vaccine without parental consent. States shouldn’t get in the way of family decisions—this is just a way of back-dooring the vaccination.

Oregon Residents - Tell your Legislators to Support Vaccine Free Choice!

A bill before the Oregon legislature, SB132, would be devasting to vaccine free choice, removing the religious exemption for vaccines, making new requirements for personal exemptions (including a signed note from a medical professional), and adding a requirement that parents watch a vaccine education module. Tell your legislators to oppose this bill: states should not interfere in personal choices and beliefs when it comes to vaccines! This bill just creates new hurdles, and shows Oregon’s lack of trust in individuals to make informed choices.

Texas Residents - Tell your Legislators to Support Vaccine Free Choice!

A mandatory vaccination bill before the Texas legislature would trample citizens' freedom of choice. SB64 would require employees of childcare facilities be vaccinated against all “vaccine-preventable diseases.” Let Texas legislators know how dangerous and offensive this bill is.

Vermont Residents - Tell your Legislators to Support Vaccine Free Choice!

Two bills before the Vermont legislature deal with vaccine rights. HB114 would require a pertussis vaccination for teachers and childcare workers. The vaccination contains the pertussis toxin that, although it is at a low dose and in a purer form than it was several years ago, can still cause brain inflammation and a severe systemic inflammatory reaction. HB138 would nullify the philosophical exemption for mandatory vaccinations if the number of those unvaccinated falls below 90%. Tell your legislators to oppose both these bills.

Virginia Residents - Tell your Legislators to Support Vaccine Free Choice!

A bill before the Virginia legislature deals with vaccine rights. HB1614 requires that boys receive the human papillomavirus (HPV) vaccine. It is outrageous that this vaccine has been mandated for girls in some states. To mandate it for boys is no less outrageous. The vaccine will have no effect on 87% of the HPV viruses that might potentially cause cancer, and the causal link between HPV and cervical cancer is far from definitive. Tell your legislators to OPPOSE this bill.

Allow a Smart Meter in Your Home—or Face Arrest!

ANH-USA — Tue, 05 Feb 2013 21:00:25 +0000

Illinois mothers were arrested for preventing the installation of “smart meters” on their properties. It could happen to you. Action Alert! Naperville, Illinois, a suburb of Chicago, has started the Naperville Smart Grid Initiative which requires so-called smart meters to be installed in every home. Residents opposed to the smart meters have been fighting the initiative for over two years. One of those residents, Jennifer Stahl, refused to give utility workers access to her backyard through her locked gate. In 2011 Stall had spoken before the Naperville City Council to advocate against the smart meter program. The police were called, and the police sergeant said the workers had authorization to access the meter, but Stahl stood her ground. The lock on Stahl’s fence was cut, and when she wouldn’t step away from the meter, Stahl was handcuffed and arrested for “interfering with a police officer.” “The city has always had and maintains the right to access our equipment, and today we were simply exercising that right,” Naperville City Manager Doug Kreiger told the Chicago Tribune. Another Naperville resident, Malia “Kim” Bendis, was arrested on two misdemeanors for resisting a police officer and attempted eavesdropping when she filmed police on the scene, despite a recent federal court ruling that the state of Illinois’s ban on recording police officers in the line of duty was unconstitutional. The US Supreme Court upheld that ruling in November. The group Naperville Smart Meter Awareness has filed motions to dismiss the charges and to grant temporary restraining orders for residents refusing the meters. There is a pending federal lawsuit as well. As we reported in 2011, the meters work on a wireless radio frequency (RF) system, and many people are concerned about the meters’ threat to their health. There are already over 2,000 studies showing negative effects of RF radiation, despite the manufacturers’ safety claims. People with the meters installed on their homes have reported symptoms such as headaches, insomnia, and tinnitus. A growing body of research points to the health risk of RF and extremely low frequency (ELF) radio waves. Studies show that RF radiation from cell phones have been linked to brain damage, early onset Alzheimer’s, senility, DNA damage, and sperm die-offs; the RF signal from smart meters is much stronger, so the effects will likely be proportionately dramatic. The World Health Organization reversed its stance on RF from cell phones, now calling them “possibly carcinogenic,” and the American Academy of Environmental Medicine has called for a moratorium on the installation of transmitting utility meters:

The current medical literature raises credible questions about genetic and cellular effects, hormonal effects, male fertility, blood/brain barrier damage and increased risk of certain types of cancers from RF or ELF levels similar to those emitted from “smart meters.” Children are placed at particular risk for altered brain development, and impaired learning and behavior….The American Academy of Environmental Medicine finds it unacceptable from a public health standpoint to implement this technology until these serious medical concerns are resolved.

Opponents of the smart meters have also cited security concerns, because the meters are capable of tracking exactly when a customer is using electricity, and opponents fear it would allow strangers to know when they are home or have gone to work. Some fear hackers could access that information. The city maintains that homeowners can opt out of the wireless transmitters but only by substituting those with an alternative meter at a high fee. The Tribune reports there is a $68.35 initial fee for the alternative meter plus a $24.75 monthly fee for manually reading it. Stahl said residents who want a non-wireless meter should not have to pay for it. The arrests that happened in Illinois could happen in your state. States have a patchwork of laws governing whether residents can opt out of smart meters, and whether there is a fee associated with opting out. These other states allow residents to opt out of having a smart meter: California (up to a $75 analog meter set-up fee and up to a $10 monthly reading), Maine ($40 set up, $12/month), Maryland (fee to be determined, but a grassroots coalition is planning to introduce a bill to eliminate the fee), Michigan (proposed $87 fee, and $15 monthly), Nevada ($108 opt-out fee for northern NV and $99 for Southern NV, $8 monthly charge), and Oregon ($254 analog set up fee, $51 monthly charge). In other states, there is no alternative option offered. For example, in Virginia, residents have been told to accept the meter or have their electricity turned off. The problem, of course, is that electricity companies are usually government-supported monopolies, so they really don’t have to worry about what their customers want. Action Alert! In New Hampshire and Virginia, there is legislation pending that would require customer consent before installing a smart meter; a bill in Maine would eliminate the opt-out fee. If you live in one of these states, we have a special, targeted action alert on these bills. If you live in any state that has no opt-out law, or an opt-out law for a fee, please contact your legislators today and demand that opting out of the smart meter be free of any fees. Please take action immediately! New Hampshire Support HB454, a bill that would allow a smart meter opt-out. New Hampshire Action Alert Virginia Support SB 797, a bill that would allow a smart meter opt-out. Virginia Action Alert Maine Support LD 94, a bill that would remove the smart meter opt-out fee. Maine Action Alert California, Michigan, Nevada, and Oregon Tell your state legislators to pass a law prohibiting utilities from charging customers a fee just because they want to opt out of having a smart meter installed on their property. Action Alert All other states Your state needs a bill that would prohibit electric utility companies from installing a smart meter on a customer’s premises—or requiring a customer to use any advanced meter—unless the customer has requested it, without having to pay a fee. If your action alert doesn't go through, you're in luck, your state either already has a free opt-out law, or has no plans to install smart meters at all. Action Alert

Vaccinating Newborns Is No Longer Enough

ANH-USA — Tue, 05 Feb 2013 20:00:22 +0000

Now they want to vaccinate pregnant women with potentially dangerous vaccines. Where will this lunacy end? The old DTP vaccine caused brain damage in infants. The new DTaP vaccine has uncertain risks—and also may not work. The government solution is to start vaccinating even before birth. This is part of the Centers for Disease Control and Prevention’s new recommended vaccine schedule—which includes notable changes. The CDC is recommending that pregnant women receive the DTaP vaccine during the later stages of their pregnancy, to protect the mother from diphtheria, tetanus, and pertussis (whooping cough), and then pass that immunity on to the fetus through the placenta. The justification is that most babies become ill or die from these diseases before they are old enough to be vaccinated, so this will give them immunity before they’re even born. The problem is that one of the elements of the vaccine, for whooping cough (pertussis), can be very dangerous. The whole-cell pertussis vaccine was created in 1912 and contains B. pertussis bacteria. Its toxins (both exotoxins and endotoxins) are some of most lethal in nature, causing tremendous inflammation throughout the body. When a vaccine of this sort is created, the bacteria’s exotoxins are inactivated or suppressed in the lab while other properties, typically immunogenicity, are maintained so that the body will create antibodies. With the pertussis vaccine, its exotoxins can cross the blood–brain barrier under certain conditions, which can trigger brain inflammation (encephalitis) and cause permanent brain damage. This is the version that was in the old DTwP vaccine (the w stands for whole-cell pertussis). About twenty years ago the pertussis vaccine was reformulated into a less reactive version with fewer side effects called the DTaP vaccine; the a stands for acellular. The DTaP vaccine still contains the pertussis toxin, albeit at a lower dose and in a purer form, so the danger of brain inflammation still exists. B. pertussis also produces endotoxins, and the immune system’s reaction is similarly inflammatory, releasing so much histamine that it can sometimes cause high fever, swelling, diarrhea, collapse, shock, and death. The newer DTaP vaccine also contains these endotoxins. Then there are the preservatives such as aluminum. Are we really crazy enough to want to expose unborns to this? DTaP recommendations have also been expanded to include routine vaccination of adults aged 65 and older despite the aluminum, which has been linked to Alzheimer’s disease. Ironically, even mainstream medicine is beginning to question whether the pertussis vaccine is all that effective in first place. There’s a worldwide epidemic of whooping cough going on, and the vaccine doesn’t seem to be doing much to prevent the disease. Immunity seems to be weak and to wear off rather quickly—in as little as three years. Is it even worth the risk? As our colleagues at ANH-Europe point out:

Much of the effectiveness of the whooping cough (pertussis) vaccine is a statistical mirage; it’s hardly surprising that the current US outbreak is occurring against a background of record vaccination rates. Washington, for example, one of the states worst affected by the current outbreak, recorded that 92.9% of children aged 18–36 months received 3 or more doses of the diphtheria, tetanus and pertussis (DTaP) vaccine in 2010–11.

The CDC’s new vaccine schedule also removes previous precautions about pregnant women being given the hepatitis A vaccine—despite the fact that its safety for pregnant women has not been determined. Moreover, hepatitis A has a mortality rate of less than 1%, and almost everyone who gets it recovers without treatment. So why is a vaccine necessary? Some hepatitis A vaccines contain aluminum as an adjuvant. Why recommend pregnant women expose themselves to the vaccine’s risks with so little benefit? Several states have introduced vaccine legislation that we’re keeping an eye on. Because the number of bills is large, we won’t include all the alerts here. Instead we’ll shortly send out individual alerts to readers in each affected state.

Not Sure the Flu Vaccine Works?

ANH-USA — Tue, 05 Feb 2013 19:00:38 +0000

Some vaccine manufacturers seem to agree! The CDC lists seven vaccines for 2012–2013 flu season. Of those, three of the vaccines acknowledge in their package insert that “There have been no controlled clinical studies demonstrating a decrease in influenza disease after vaccination.” Two other flu vaccines, Intranasal Flu Mist and Fluarix Quadrivalent, are four-in-one vaccines which appear to be backed by some clinical trials. But as we reported last month, the peer-reviewed medical journal The Lancet found that only 2.7% of non-vaccinated adults caught the flu, which means that 97.3% of them did not. Among vaccinated adults, 1.2% caught the flu. This means our big national vaccine drive will keep a whopping 1.5 people out of 100 from catching the flu. It would be helpful to have more data about the number of people vaccinated who go on to catch the flu. But the governments does not appear interested in gathering that data. So we’ve created this graphic. We hope you’ll share it on Facebook and Twitter and Pinterest and your favorite social networking sites. Perhaps it will change a few minds out there!

Editor's Note 2/6/2013: An earlier version of this article contained a typo stating that the Lancet study reported that among vaccinated adults 1.2% did not catch the flu, when in fact the study reported that 1.2% did catch the flu.

Urgent Action Alert – for Indiana Residents! UPDATED

ANH-USA — Fri, 01 Feb 2013 13:34:08 +0000

UPDATE - Newly added amendment language would give a Dietetics board (majority RD's) the power to turn complaints/individuals over to the attorney general for investigation.

This new language creates the mechanism for the Dietetics board to harass and undermine unlicensed practitioners as they have been doing in other states.

In the absence of any significant, or vetted, documentation of harm to the public from non-RD practitioners, Academy of Nutrition and Dietetics has adopted strategy of filing complaints to convince legislators of the need for exclusionary laws. This new language creates the mechanism for the Dietetics board to harass and undermine unlicensed practitioners as they have been doing in other states

Contact your elected representatives in Indiana TODAY and let them know that the Dietetic Association—which is funded by the junk food industry—will not monopolize the nutrition profession in Indiana!

Click Here to Take Action

FDA Again Ignores Instructions from Congress

ANH-USA — Tue, 29 Jan 2013 22:00:55 +0000

And turns a blind eye to allergic reactions from Big Farma’s favorite foods. Action Alert! In 2004 Congress passed the Food Allergen Labeling and Consumer Protection Act (FALCPA), which required that food labels state clearly when any of eight “major food allergens,” are present in the product. These eight foods or food groups are milk, egg, fish (e.g., bass, flounder, cod), crustacean shellfish (e.g., crab, lobster, shrimp), tree nuts (e.g., almonds, pecans, walnuts), wheat, peanuts (which are not true nuts, but legumes in the same family as peas and lentils), and soybeans—or an ingredient that contains a protein derived from one of these foods. Why these eight? Because they account for 90% of the most obvious allergic reactions to food. They produce classic, immediate allergen responses, such as a closing of the throat, sneezing, an asthma attack, or hives. These are all caused by the reaction of an antibody called Immunoglobulin E (IgE). The medical establishment is not taking into account the internal and often silent IgG or IgA immune responses like those to gluten, which can create inflammation or intestinal permeability, not to mention irritable bowel syndrome. It’s not just a matter of discomfort: our immune system “resides” in our gut. When the small intestine is damaged, our entire immune system is vulnerable. Gluten should technically be in the big eight anyway, since it is a protein found in wheat, but is not included in the labeling scheme. The list also fails to mention allergenic effects from flavoring, preservatives, additives, etc. Despite this emphasis on the Big Eight, when Congress instructed FDA to determine threshold levels of allergens that must be labeled, it also required threshold levels for gluten, mainly so that some products could safely call themselves “gluten-free.” In another “here we go again” moment, FDA is working on the labeling thresholds for the eight “major allergens,” but is choosing to ignore the gluten issue—probably because gluten is in so many foods, and the food industry won’t like it. A maximum threshold of 20 mg of gluten contamination per kilogram of food marketed as gluten-free has been successful in protecting celiac consumers in Europe, according to a new study published in the American Journal of Clinical Nutrition. We are not always a fan of international standards, but in this case agree that the US threshold should be consistent with them. Gluten is not an issue to be swept under the rug in order to please industry. A shocking number of people have an allergic immune reaction that causes damage to the inner surface of the small intestine whenever they ingest it while eating bread, pasta, cookies, pizza crust, and many other foods containing wheat, barley, or rye. The intestinal damage causes an inability to absorb nutrients, depriving the brain, peripheral nervous system, bones, liver, and other organs of vital nourishment. It can also cause abdominal pain and diarrhea. As we reported previously, severe cases can infertility, as well as an increased risk of osteoporosis and certain cancers, particularly colon cancer. One in 133 people have celiac disease, the most dramatic form of the food allergy. But researchers say between ten and thirty percent of Americans—up to 100 million people in our country—have non-celiac gluten sensitivity, with more subtle immune reactions, like dermatitis herpetiformis, a skin rash often confused with eczema or psoriasis. They suffer intestinal damage and Leaky Gut Syndrome but may experience no intestinal distress. Gluten sensitivity may be responsible for a number of chronic illnesses, fatigue, arthritis and other immune system reactions, and brain and neural network malfunctions. Interestingly, given the FDA’s obsession with developing and approving weight loss drugs, a new study has just determined that wheat gluten may promote weight gain. The researchers found that mice fed a gluten-free diet showed a reduction in body weight gain and body fat percentage when compared to mice fed a diet containing gluten—with no other changes in the amount of food they ate or the number of calories they consumed. This indicates that gluten disrupts endocrine and exocrine processes within the body, and directly modulates nuclear gene expression in such a way as to alter mammalian metabolism in the direction of weight gain. Ignoring Congress’s instructions about gluten is bad enough. But this is not the only other major allergen being ignored. A study in the New England Journal of Medicine showed that genetically modified soybeans can cause an allergenic response. Allergies have already skyrocketed in the US, and with the introduction of GE soy in the UK, soy-related allergies rose by 50%. GMOs also cause immune system dysregulation, with changes in the number of immune response cells showing up in the gut, spleen, and blood of mice—all of which points to an allergenic and inflammatory response to GMOs. At minimum, GMO versions of the “big eight allergens” need to be considered when setting threshold levels because triggering levels are lower for GMO foods. This is just one more proof that GMO foods are materially different from non-GMO foods—a fact that the FDA consistently ignores. If they admit there is a difference between GMO and non-GMO foods, GMO would be considered “materially different” from other foods, and could legally be required to be labeled. Action Alert! The FDA is asking for comments on establishing thresholds for food allergens for labeling purposes and enforcement action. Please tell the FDA that they should broaden their scope to look at gluten, in addition to the so-called “major” food allergens. Ask them to consider the exacerbating effect that GMOs have on food allergies (e.g., the threshold level for GMO soy might be different than for conventional soy). And tell them to consider IgA and IgG allergenic responses in addition to the more dramatic IgE responses. Long-term but health-damaging allergic responses are as important—and far more widespread—than reactions to the “big eight.”

Global Treaty Will Nix Mercury—But NOT in Vaccines!

ANH-USA — Tue, 29 Jan 2013 21:00:12 +0000

Why is one of mercury’s most dangerous applications—human vaccines—exempted from the ban? An update to our recent report. A week of complex discussions in Geneva ended with governments from around the world agreeing to a global, legally binding treaty to limit mercury use. The Minamata Convention on Mercury, named after the Japanese city where thousands of residents fell ill with mercury poisoning in the 1950s, bans the production, export, and import by 2020 of a wide range of products and processes where mercury is used or released. Products include implantable medical devices, switches and relays, certain fluorescent lamps, soaps and cosmetics, and some medical devices such as thermometers and blood pressure devices. Mercury-added dental amalgams are also to be phased out. What’s exempted? Products used for military and civil protection; those with no mercury-free alternative; those used in religious or traditional practices; and vaccines in which the organomercury compound thimerosal, about which we have written about extensively, is used as a preservative. Countries will be invited to ratify the treaty, which took four years to negotiate, at a meeting in Japan in October, but it is not expected to come into force for another three to five years. A 2009 study published in the journal Toxicological & Environmental Chemistry found that thimerosal induces neural damage similar to that seen in autism patients—even in low levels. According to the study, “Thimerosal was found to be significantly more toxic than the other metal compounds examined.” Thimerosal is touted as being an important preservative for multi-dose vaccines, which are needed in developing countries because they don’t require constant refrigeration or as much storage space. But as noted by Dr. Russell Blaylock, multiple vaccines given close together may overstimulate the growing brain’s immune system and destroy brain cells. As Dr. Joseph Mercola points out, in 1983, before the autism epidemic began, children received ten vaccinations before attending school. Today they receive twenty-four vaccines before the age of 1, and thirty-six by the time they attend school. And that’s not including the recommended seasonal flu shot each year. Although mercury is not used in most vaccines in the US now, it is still used in the flu vaccine. And if it has been phased out in the US apart from the flu shot, why should it be used on Third World kids? In 2005, Robert F. Kennedy, Jr., wrote a searing exposé of the government cover-up of the news that mercury in childhood vaccines had been linked to autism in thousands of children, and tried to prevent parents from suing drug companies for their role in the epidemic. It comes as no surprise to learn that once again, vaccines in general are exempted from the mercury ban. Apart from vaccines, it will also be interesting what effect the treaty has on the light bulb industry in the US: the treaty says that by 2020 the production, export, and import of certain types of compact florescent lamps (CFLs) (aka energy efficient lights) will be banned. However, until we have the full report, we won’t know the specifics. When Congress passed a ban on traditional light bulbs, we pointed out that the replacement fluorescent bulbs were more energy efficient but also contained mercury. Most people wouldn’t know that. If a bulb broke, they wouldn’t take care in disposing of it. And how would society as a whole safely dispose of masses of used, mercury-contaminated bulbs? Our more thoughtful friends in the environmental movement agreed with us, but Congress proceeded with the ban on old bulbs anyway. In the long run, this will stimulate the development of bulbs that are both energy efficient and mercury free, such as LED lights—but in the meantime, will the new treaty lead Congress to reconsider?

Alternatives to Cancer, Inc.

ANH-USA — Tue, 29 Jan 2013 18:00:30 +0000

A conference coming up in April reminds us that there is a lot going on in integrative cancer treatments. Conventional treatments (“cut, burn, and poison,” essentially) work for a few types of cancers, but completely fail for many. Consider these five-year cancer survival rates:

Esophageal: 3% for esophageal cancers that metastasize, which is common in this aggressive cancer; the average for all forms of esophageal cancer is 15–20%
Lung: 4% for lung cancers that metastasize; the average for all forms of lung cancer is 16%
Pancreatic: 2% for pancreatic cancers that metastasize; the average for all forms of pancreatic cancer is 6%

Despite these dismal statistics, the conventional cancer industry resists change. Patients with little chance of being cured with chemo get chemo anyway, even though it eliminates any chance the body will recover on its own and makes the end of their life much more miserable than it would have been. Even worse, scientists have found that healthy cells damaged by chemo can secrete a protein which makes cancer worse by triggering more tumor growth. Moreover the cancer cells that survive chemo tend to be the more aggressive ones, which can also lead to faster tumor growth. It’s not as if the conventional cancer industry does not have any new ideas. But even when it does have one, it seems to take forever to get it approved and used. A striking example is the use of focused ultrasound as an alternative to surgery and radiation treatment. This major innovation has been used very successfully for prostate and even brain surgery, but is still not used very often or in many areas where it should be, such as esophageal cancer. Why should Americans have to fly to Japan to get this exciting new treatment? Meanwhile, integrative cancer treatments are forging ahead, despite being ignored and denigrated by the medical establishment and the government. One of the most exciting integrative cancer treatments is Insulin Potentiation Therapy, or IPT, also called Insulin Potentiation Targeted Low Dose (IPTLD). It’s a procedure for targeting chemo drugs directly to cancer cells, making the drugs tougher on the disease and easier on the rest of the body. Each of our trillions of cells has a membrane, an outer skin, that protects it from toxins. Standard chemotherapy must be given in large enough quantities to force penetration through that membrane, with the result that the body is flooded with incredibly toxic drugs. IPTLD, however, penetrates easily through the cell membrane because it goes in hand-in-hand with sugar (glucose). Cancer cells, unlike healthy cells, need lots of glucose for fuel. Without it, they die. The membrane of a cancer cell is designed to take in a lot more glucose than healthy cells—they are equipped with many more insulin receptors. So if one pairs a small dose of chemo drugs with the glucose, the cancer cell takes in the chemo in its effort to get at the sugar. This means the rest of the body doesn’t have to be assaulted in order to kill the cancer cells. The therapy uses only one-tenth the usual amount of chemotherapy drugs. The eleventh annual IPT/IPTLD Integrative Cancer Care Conference, to be held April 18–20 in Dallas, will feature presentations by experts in their fields on different aspects of integrative cancer care, with an emphasis on therapies that are kinder and gentler but still powerfully effective. Besides the latest in IPTLD treatments, they’ll look at comprehensive healing techniques and tools like diet and nutrition, as well as toxins/detox as they relate to cancer and chronic diseases, with an emphasis on individualizing non-invasive cancer care, rather than promoting an invasive one-size-fits-all approach. Besides IPT, among some of the other well known integrative treatments are:

Dr. Nicholas Gonzalez’s enzymatic therapy for cancer, which we described in a recent article.
Dr. Jeanne Drisko’s research on the use of intravenous vitamin C at the University of Kansas.
Dr. Stanislaw Burzynski’s pioneering research on a nontoxic gene-targeted cancer therapy called antineoplastons, which has successfully survived attack after attack from conventional medicine and the Texas state medical board.

In addition, there is the important integrative research on diet. As Dr. Frank Shallenberger points out in his RealCures newsletter, diet is an extremely important part of cancer prevention and treatment. Cancers can only live off sugars, whether they are in the form of simple sugars or are broken down from more complex carbohydrates. Drastically lowering one’s carbohydrate intake, especially carbs that turn to sugar quickly, can slow cancer growth by 50%. Dr. David Williams also points out (in his January 2013 newsletter article “The Argument Against Being ‘Normal’,”) some of the studies showing a connection between sugars and cancer: elevated blood sugar levels are linked with colorectal cancer in postmenopausal women; high carb intake is linked to an increased risk of recurrence and mortality in stage III colon cancer patients; and the higher your fasting blood glucose is, the higher your risk for several major cancers. Most people don’t die of cancer; they die of cachexia, whose symptoms are progressive weight loss, anorexia, and erosion of host body cell mass in response to cancerous growth. The connection to cancer isn’t fully understood, but one possibility is that the body is trying to starve the cancer and in the end overdoes it, like the too-strong inflammatory reaction in the lungs that actually kills most people who die of flu or pneumonia. This underscores the likelihood that cachexia is best treated by a radical change in diet. Yet many conventional doctors still tell their cancer patients that it doesn’t matter what they eat! Cancer patients in hospitals not only get the poor food supervised by registered dieticians; they even get sweets! It is past time for conventional medicine to acknowledge its failures, open itself to new ideas, consider factors such as diet, and stop attacking and persecuting innovators. It is not just that conventional approaches are failing on some cancers. A recent Australian study shows the five-year survival rate for cancer patients who do not receive chemotherapy to be over 60%. The survival rate for patients who received chemotherapy was only 62.3%—which is virtually the same and doesn’t consider the other costs such as brain damage. Are the results any better in the US? No, the statistics are similar, only 2.1% gain from chemo, really no difference. And as noted above, chemo may actually make the cancer more aggressive and deadly. Why is medicine so committed to conventional chemo treatments? Unfortunately cancer is big business. According to the National Cancer Institute at NIH, $124.57 billion was spent on cancer treatments and cancer care in 2010 alone. As we reported in 2010, oncologists are allowed to buy chemo drugs and then dispense them from their offices at higher rates. Being able to run what amounts to a side pharmacy business (which other doctors are not allowed to do) incentivizes oncologists to prescribe expensive drugs. Another barrier to change in the cancer industry is flawed or corrupted research. Last week’s Journal of Oncology reported that most double-blind random placebo-controlled trials (RCTs) for cancer, supposedly the gold standard of scientific and medical research, are compromised by poor or biased reporting of both the benefits and the dangers. They studied 164 double-blind RCTs of mainstream breast cancer treatments (radiation, surgery, and chemo) and found that almost one-third of the trials reported a positive result that was not based on the primary goal of the study, but rather on a secondary one more likely to be due to chance. And two-thirds of the trials failed to accurately report the toxicity of the therapy. By underreporting the toxicity, researchers are hiding the fact that many mainstream cancer treatments do more harm than good. And by mischaracterizing the positive results, they are proving that the double-blind RCT isn’t the gold standard it’s cracked up to be. Let’s hope that change and reform finally comes to the cancer “industry.” In the meantime, anyone with cancer or a family member with cancer should not rely on what they are told at the nearest cancer center but should do independent research on their own. A good place to start is with the Moss Reports, published by medical writer Ralph W. Moss, PhD, who has written or edited twelve books and three film documentaries on questions relating to cancer research and treatment.

FTC Proceeds with Raw Power Grab on Health Claims—In Effect Thumbing Its Nose at Congress

ANH-USA — Tue, 22 Jan 2013 21:00:38 +0000

Food company POM Wonderful’s battle with the FTC ends (for now) with the agency making up its own law and quashing free speech. Action Alert! Last year, an administrative law judge (ALJ)* for the Federal Trade Commission upheld the pomegranate juice manufacturer’s right to make what the FDA would call structure/function claims in ads. Structure/function claims include statements such as “calcium helps build bones.” They don’t directly talk about curing a disease. At the same time, the ALJ found that some of the company’s claims went too far (specifically where they claimed the juice could help heart disease, prostate cancer, and erectile dysfunction). Because the ALJ’s decision was a partial victory for both POM Wonderful and the FTC, both sides appealed, which necessitated a ruling from the FTC as a whole. Last Wednesday, the Commission took a much more unreasonable line. It found that thirty-four of POM’s forty-three claims were implied disease claims—fifteen more than the ALJ had found. The full Commission further ruled that a double-blind random-controlled trial (RCT) is required for any “efficacy” claim and two double blind RCTs for any claim that might seem to be related to a disease. The $35 million on peer-reviewed scientific research previously spent by POM was brushed aside because the studies were not RCTs, which are commonly used for drug testing. This is a major one–two punch. The FTC is being draconian about what it considers an implied disease claim. One commissioner noted in remarks accompanying the decision: “It is difficult to imagine any structure/function claims that POM could associate with its products in the marketplace without such claims being interpreted, under the FTC precedent set in this case, as disease-related claims.” In making these judgments, the agency has relied on what is legally called its own “net impression,” i.e., totally subjective judgment, and has ignored the ALJ’s request for a higher standard of “extrinsic evidence,” the sort of evidence that would come for example by testing how consumers actually interpret a label. The agency is also requiring the hugely expensive pharmaceutical standard of the double-blind RCTs. As we have often noted, companies do not usually attempt RCTs because of their expense, unless they hold a patent on the substance being tested. And it is not possible to patent natural substances such as food. The FTC understands this. In effect, they are saying that food manufacturers will not be allowed to talk about health benefits, period. It is a complete gag order. The ruling also blurs the line between the FTC and the FDA. The double-blind RCT for disease claims is an FDA labeling standard for drugs. The FTC is supposed to regulate advertising, not decide what is a drug. Its mandate is to ensure that advertisements are not deceptive or misleading—something that certainly does not require the pharmaceutical RTC standard! Now the FTC is unnecessarily and arbitrarily deciding to use an FDA drug standard for disease claims in advertising. Some industry observers even wonder whether the FDA has asked the FTC to do this because the FDA would not be able to go this far on its own. There is absolutely no statute justifying this. It is making up law without congressional approval. Congressman Henry Waxman (D-CA) in particular has already tried and failed to give the agency the power to do this—in a sneaky and underhanded way. You may recall that in 2010, Waxman tried to slip an amendment into a totally unrelated bill. That amendment, which was intentionally written in obscure language that nobody but an expert could understand, would have given the FTC expanded powers and rulemaking authority, giving them the power to create new kinds of regulations without going back to Congress. (It lost that authority in the 1980s because Congress thought the FTC was abusing it. How ironic.) With your help, the amendment failed. Having in effect been told no by Congress, the agency is just going ahead anyway, seemingly on a case-by-case basis, creating regulations with no legal basis. Who benefits from such a change in policy? Just follow the money. If the FTC prevails in requiring double-blind RCTs, only pharmaceutical companies will be able to make health claims on their patented and FDA-approved products. The Commission’s decision directly affects only POM Wonderful (along with all its affiliated companies despite the fact that POM was the only company at issue here!). But it sets a powerful precedent and makes it clear that the FTC will try to enforce this as widely as possible. Food, drug, and constitutional law attorney Jonathan Emord called the decision “arbitrary and capricious” and said, “The breadth of [the FTC’s new two-RCT] requirement is truly astonishing….After today’s decision, the health marketplace will be dumbed down considerably to the detriment of health conscious consumers….In the end, that will mean a loss in public health as there will now be a multi-million dollar entry fee imposed on any who would wish to convey a health benefit to consumers in the market.” This is just one more reason we need to pass the Free Speech about Science Act, which would allow natural product companies to cite peer-reviewed science in their advertising. For now, we need to let Congress know that the FTC is trying to make an end run around the legislative process. Having been turned down by Congress, the FTC is proceeding as though empowered anyway. Action Alert! Let’s be sure that Congress understands that voters are watching, and voters care about this example of agency lawlessness. Please take action now.

* An administrative law judge does the initial hearing of cases in the FTC’s administrative complaint proceeding. The ALJ issues the initial decision setting out relevant findings, explains the legal standard, applies the law, and issues an order. Only if the ALJ’s ruling is appealed does the case go before the full Commission.

Have You Heard about the Famous Anti-GMO Scientist Who Switched Sides and Is Now Pro?

ANH-USA — Tue, 22 Jan 2013 19:00:30 +0000

For one thing, he isn’t a scientist at all. This episode has been all over the media. Some commentators have speculated that this will turn the tide in Europe and persuade regulators there to give a full green light to GMO. But let’s take a moment to review the facts. Mark Lynas is not a scientist. He does not even reveal his education on his own website, nor is it easily available on the Web. He is a British author, journalist, and environmental activist with a flair for publicity and a primary focus on climate change. He’s been called a “pioneer” and an “apostle” of the anti-GMO movement, but that is mostly his own self-promotion. At a farming conference in Oxford, England, earlier this month, he gave a speech reversing his previous position on GMO in characteristically dramatic style: “You are more likely to get hit by an asteroid than to get hurt by GM food.” Obviously no scientist would make such a statement given the lack of established facts about GMO. It is precisely the lack of proven facts which are the problem. Lynas added, just to stir the pot further: “More to the point, people have died from choosing organic, but no one has died from eating GM.” Of course he provided no support for that wild claim. Lynas says he was blinded by the anti-GMO rhetoric, that “ the debate is over” and there is a “scientific consensus” in favor of it, which is patently false. He told NPR that he originally came out against GMO without studying it, which we believe. While this may be indicative of his immaturity at the time—this is, after all, the same fellow who threw a cream pie in the face of climate-change-denier Bjorn Lundborg—it may also indicate his ability to be persuaded by whoever is yelling the loudest at the time. In his speech at Oxford, Lynas made a number of more specific claims about the safety and effectiveness of genetically engineered crops. Let’s look at them and see how they stand up to all the scientific evidence:

“I’d assumed that GM benefited only the big companies. It turned out that billions of dollars of benefits were accruing to farmers needing fewer inputs.” Lynas says GMO benefits small farmers, who rely on and want the seeds. Not true. Farmers in India went into debt to buy GE seeds, hoping for increased yield, and when those crops failed due to pest infestation, they were left more impoverished with no prospects for the future. Farmers were not told that the crops would require twice the amount of water, and that the crops do not produce viable seeds—which means the farmers would have to keep purchasing new seeds. In response, many farmers killed themselves. The rate of Indian farmer suicides began increasing after the introduction of Monsanto’s Bt cotton in 2002, and two-thirds of farmer suicides occur in five Indian states, which has come to be known as India’s “Suicide Belt.” Over 17,000 farmers in India committed suicide in 2009 alone because of Monsanto and GE seeds. Many of the farmers made their suicides a symbolic act by drinking Monsanto’s pesticide. Lynas’s primary argument here is that GMOs will feed the world and increase crop yields. Our extensive article shows that this simply isn’t true.
“I’d assumed that it would increase the use of chemicals. It turned out that pest-resistant cotton and maize needed less insecticide.” True about insecticides, but wrong about the rest—insecticides are not the only chemical problem. GMOs have dramatically increased the use of herbicides. Roundup Ready crops have grown resistant to herbicides, creating superweeds that require even more dangerous and toxic herbicides.
Lynas calls the regulatory system in Europe burdensome, unnecessarily increasing the cost of GMOs. Not everywhere! Here in the US there is no regulatory system specific to GMOs, turning consumers into human guinea pigs, and concentrating money and power in the hands of few powerful biotech companies, with the USDA rubberstamping GMO deregulation to the benefit of Big Farma.
“I’d assumed that GM was dangerous. It turned out that it was safer and more precise than conventional breeding, using mutagenesis for example.” Safer than mutagenesis, a process that involves exposure to radiation and chemicals? Maybe. Safe? Categorically untrue. For someone who says he has come to love the scientific method, this is a remarkably unscientific conclusion, because there have been no long-term human studies supporting the safety of GMOs. What is most notable about the GMO field is the lack of independent, objective, and long-term studies in humans. There have, however, been plenty of animal studies, and here the science is becoming clearer: GMOs may be causing birth defects, high infant mortality rates, fertility problems, and sterility in hamsters, rats, mice, and livestock fed GMO soy and corn, and some hamster pups even began growing hair inside their mouths. Studies indicate other serious health risks as well: immune system dysregulation, with changes in the number of immune response cells showing up in the gut, spleen, and blood—all of which points to an allergenic and inflammatory response to GMOs; increased aging (especially in the liver); dysregulation of genes associated with cholesterol synthesis, insulin regulation, cell signaling, and protein formation; and changes in the liver, kidney, spleen, and gastrointestinal system.

The real story here is not Lynas’s antics, from pie-throwing to dramatic recantations. It is the media’s coverage of the latest self-promotional stunt. Cover the stunt if you like, but please do not pretend that this has anything remotely to do with science. Editor’s Note, 1/25/13: In an earlier version of this article, we included an abbreviated quote by Mark Lynas on the safety of GM.

Don’t Be Confused: Backscatter Machines Are Not Being Eliminated

ANH-USA — Tue, 22 Jan 2013 19:00:10 +0000

The “naked body” airport scanners are being scrapped—but that does not mean the end of dangerous x-ray airport screening machines. Action Alert! The Transportation Security Administration (TSA) has agreed to drop its contract with OSI Rapiscan, manufacturer of the airport body scanners that produce a naked image of travelers, because of privacy concerns. This really isn’t much of a victory, however. TSA has signed a new contract with a different manufacturer of scanners, whose machines will still have the radiation backscatter problem we reminded you about last month. TSA decided to end its $5 million contract with OSI Rapiscan because the company couldn’t meet its congressionally mandated deadline to address privacy concerns and create software that showed images of travelers that would be more generic and less explicit. TSA had already decommissioned a third of Rapiscan’s backscatter machines and will now get rid of the remaining 173. TSA has meanwhile maintained its contract with makers of scanners that use millimeter waves, which produce a generic unisex outline that resembles the cartoon character Gumby. The agency could have gone to all millimeter wave scanning, which is thought to be safer. But no, backscatter machines will still be in airports. TSA signed a $245 million dollar contract with American Science and Engineering, a company that uses the same x-ray backscatter technology as Rapiscan for their machines, but which also has software that addresses privacy concerns. In other words, while passengers may not have their privacy violated any more, they still will have their health endangered. As you may recall from our report on the machines last July, they emit low levels of ionizing radiation with levels that could be 10 to 20 times higher than the manufacturer’s calculations. A report from the Department of Homeland Security found inconsistencies in how the machines are calibrated to ensure radiation safety and image quality, and noted that not all TSA screeners have completed required radiation safety training. Millions of people go through these machines—and ProPublica reports that up to 100 US passengers could get cancer from them every year. Both TSA’s own procurement specifications and a subsequent report by the Government Accountability Office indicate that the machines were never designed to detect powdered explosives. This is particularly ironic since the machines’ use was initially justified after the underwear bomber incident—which involved powdered explosives! The Rapiscan machines were selected by Michael Chertoff when he was head of the TSA under President Bush. As soon as he left office, he signed on with the company as a very highly paid promoter of the machines. By the way, Rapiscan’s machines aren’t disappearing—they’re just being relocated to government agencies! Action Alert! Congress needs to know that now is the time to get rid of all the backscatter machines because of their danger to our health—privacy is not the only concern! Tell them TSA needs to use millimeter wave scanners exclusively. A failure to do so when the existing machines are being taken out of airports is inexcusable. Take action now!

AMA Pediatrics Group Wants to Keep Mercury in Our Vaccines—Action Alert!

ANH-USA — Tue, 15 Jan 2013 20:00:18 +0000

Would you be surprised to learn that vaccine makers are among their corporate donors? And that their recommendations influence the FDA? Take Action! In 1999, the American Academy of Pediatrics (AAP), together with the US Public Health Service, jointly recommended that thimerosal, a vaccine preservative that contains mercury, should be removed from vaccines. In response, the FDA removed thimerosal, or limited it to trace amounts, in all vaccines except flu shots. Now the AAP has reversed itself and says it wants the mercury left in. In January, the UN Environmental Program will be working on a global treaty to reduce health hazards by banning certain products and processes that release mercury into the environment, and thimerosal in vaccines is one of those products under discussion. The World Health Organization (WHO) has stated that thimerosal should be left in vaccines and should not be banned. They argue that the mercury compound helps control the growth of bacteria and fungi in multi-dose vaccines (though not necessary for single-dose vaccines). In the developing world, multi-dose vaccines are a mainstay because single-dose vials would cost far more and require new networks of cold storage facilities and additional capacity for waste disposal, according to the WHO statement. In a direct reversal from their previous position, AAP has endorsed WHO’s report. This could shift the FDA’s stance on the issue, and might even bring back thimerosal into other US vaccines. Nor is this the first time the AAP has done something that strikes us as hard to explain without looking at their donors. The group previously said that boys should receive the HPV vaccine, which is dangerous and offers few benefits for boys relative to the risks; advocated that children receive cholesterol screenings, which could lead to big business for the drug companies selling statin drugs even though statins are the last thing growing bodies need; and recommended sports drinks for kids that are full of sugar and questionable additives, and expensive for consumers but that are very lucrative for the sellers. We worry that all these decisions were influenced, not by the needs of children, but by the funding needs of the organization. Consider also AAP’s stance on organic food. While recognizing that there are lower pesticide levels and a lower risk of exposure to drug-resistant bacteria in organic food, the AAP is still unsure whether organic food is beneficial! They made the following ridiculous statement about organic milk:

The AAP found no individual health benefit from purchasing organic milk, but emphasizes that all milk should be pasteurized to reduce the risk of bacterial infections. Raw milk increases the risk of serious infection with bacteria including Salmonella, E. coli, Listeria, Campylobacter and Brucella.

The truth, of course, is that raw milk bought from a reliable source (not an industrial farm) is usually healthier that pasteurized milk. As we noted last year, the CDC determined that pasteurized milk products cause nearly twice as many illnesses as raw milk products; moreover, the pasteurization process destroys delicate proteins, enzymes, immune factors, and vitamins, and inhibits mineral availability. The very healthiest milk would therefore be raw, grass-fed—and organic. Why would AAP take such an illogical position on organic food for children? Many have noted the presence of drug, vaccine, and junk food companies at the AAP’s annual conferences. IRS docs show that AAP received large contributions from drug companies with ties to statins. Is that why the group recommends statins for children? Is all of this a coincidence? Not likely. We believe such conflicts of interest within the AAP directly affect their recommendations—and this, in turn, harms children, because some pediatricians and other health professionals blindly accept those recommendations. The organization actively solicits sponsorships from industry. And while they list some of their “corporate friends”—Merck, Sanofi Pasteur, Pfizer, Pediatrics Insurance Consultants, Abbott, Mead Johnson, Nestlé—this is not a complete list, nor does it reflect funding across all their program areas. Action Alert! Contact AAP and ask them to reveal the names of all their donors—particularly the drug companies, vaccine manufacturers, and junk food companies—together with the amount of each contribution and which program area it was for. We’ll also send a copy of your message to the American Medical Association—and Congress. We need to know who is influencing policy that directly affects your children’s health! Please send your message today!

Flu “Epidemic”: The Numbers Just Don’t Add Up

ANH-USA — Tue, 15 Jan 2013 19:00:41 +0000

Should the government be recommending mercury-containing flu shots to everyone, especially if they are useless for 97.5% of adults? One prominent media outlet says, “Influenza has reached epidemic proportions in the United States, with 7.3 percent of deaths last week caused by pneumonia and the flu,” according to the CDC. Another’s report, released the same day, says that “despite all those news reports about overcrowded emergency rooms, it’s too soon to say whether it will be worse than normal” and quoted the CDC as saying that the number of states reporting “high” levels of flu activity has actually dropped from 29 to 24. A third wonders why fewer than 65% of Americans got a flu shot this year, while a fourth notes that the flu vaccine is only about 62% effective, meaning that over a third of the people who do get flu shots still get the flu. But that 62% figure is misleading. There are currently three different “epidemics” hitting the US: “true” influenza (type A, type B, or seasonal H1N1 influenza), norovirus (“stomach flu”), and whooping cough. According to a meta-analysis published in the weekly peer-reviewed medical journal The Lancet, the flu vaccine is only 62% effective in preventing type A or B influenza or seasonal influenza A (H1N1). It doesn’t protect at all against norovirus and whooping cough. In other words, only 2.7% of all adults get type A or B or H1N1 influenza, and of them, the vaccine will fail 38% of the time, which means it really benefits only about 1.8% of the population. Moreover, even preventing traditional influenza depends on the government guessing correctly well in advance about which strains will be a problem in the coming season. This year they got two influenza strains right but missed one. In addition, there is no evidence that flu vaccine provides any protection whatsoever for adults 65 and over—even though the elderly are one of the flu vaccine campaign’s target populations. And to top it all off, the effectiveness of the whooping cough vaccine drops as time passes: a study found that the effectiveness fell from 98.1% within a year of completion of the vaccine regimen to 71.2% five or more years later. And even that figure is doubted by some scientists. As we noted two years ago, the CDC’s figures are fabricated or false. It’s as if they’re saying, “Well, we really have no idea what the truth is, so we just make stuff up.” Could it have something to do with the cozy relationship between pharmaceutical companies, regulators, and the media? Last October we told you about the flu shot being forced on healthcare workers. But it’s gotten even worse. Hospitals are incentivized to vaccinate their staff in order to receive favorable treatment under Medicare reimbursements. The Affordable Care Act established Hospital Value-Based Purchasing, which offers payment reductions if the hospital meets certain government-determined performance standards—and this often includes flu vaccination for its healthcare workers. But if the vast majority of healthcare workers who do receive the mandatory flu vaccine will get the flu anyway, how does that really help the overall health of the staff? In light of this, it becomes obvious that mandatory flu vaccination policies are financially driven, and not patient-safety driven. The problem is that some of the best healthcare workers choose not to vaccinate because they recognize the shot’s ineffectiveness—not to mention its risks—even at the threat of being fired. How absurd is it that the government is continuing to push the flu vaccine, when the shot is proving ineffective against the majority of current flu cases, and when there is a shortage of the vaccine anyway? Of course, as both Dr. Jonathan Wright and Dr. David Brownstein strongly recommend, the best advice is to skip the flu shot, build up your immunity instead with vitamin C and vitamin D, and if you become infected, take vitamin A (real A, not beta carotene). Or use other tried-and-true natural remedies.

Reader’s Corner: Cheap and Effective TB Drug Being Ignored? Action Alert!

ANH-USA — Tue, 15 Jan 2013 18:00:56 +0000

A reader brought an interesting issue to our attention: mainstream medicine is rejecting a lifesaving tuberculosis treatment—likely because it’s not profitable! Take Action! Steve wrote, “I am not a fan of Big Pharma, but you may be interested to know about a painkiller that kills TB.” And indeed we were! We looked into the issue more and found another classic case of FDA red tape blocking access to a potentially lifesaving treatment. Researchers have discovered that an inexpensive, over-the-counter anti-inflammatory drug called oxyphenbutazone, developed in the 1950s to treat arthritis but withdrawn in the 1980s, can kill the bacteria that cause tuberculosis (TB)—even the drug-resistant varieties. In terms of over-the-counter pain relief, there are safer alternatives to oxyphenbutazone, as it does have some known toxicities. However, when it comes to treating TB, oxyphenbutazone appears to be the safest treatment by a long shot. The study was done by the Weill Cornell Medical College at Cornell University and was funded in part by the TB Drug Accelerator Program of the Bill and Melinda Gates foundation. Researchers found it would cost about two cents a day to treat TB in developing countries, where the disease has reached pandemic proportions. One in ten cases of TB is drug-resistant, it’s second only to HIV as the leading infectious killer of adults worldwide (as we reported last September), and it is the third largest cause of death among women aged 15 to 44. Influenza is in the news again (see our article in this issue), but TB is far more deadly. As the Wall Street Journal recently reported, India, the US, and South Africa are taking steps to address the threat of drug-resistant TB. The CDC has a faster test to diagnose drug-resistant strains, and the US is acting to alleviate shortages of TB treatments. Unfortunately, it is unlikely that oxyphenbutazone will ever be used to treat TB patients. Companies won’t pay for clinical trials, as they aren’t likely to make a profit on a drug that’s cheap. The drug has run out of its patent protection, so now nobody wants to study it, and while it is still used extensively in veterinary medicine, for it to be approved for TB, it would need to go through the extraordinarily expensive New Drug Application process. Another obstacle is that the FDA requires testing on animals. When it comes to testing drugs, mice are by far the best (and cheapest) subjects: they share 99% of their genes with humans. But mice metabolize the drug too quickly for it to be studied that way, so in this case, animal testing would be far more expensive than with other drugs. Besides, FDA-mandated clinical trials aren’t always the best way to study new drugs. As we noted last year, they are also frequently misused, as Dr. Nicholas Gonzalez found during the clinical trials for his groundbreaking integrative cancer treatment. (On a humorous note, at least oxyphenbutazone can be used in Scrabble. The word holds the title for the highest possible score for a single play under American tournament Scrabble rules, scoring 1,780 points across three triple-word-score squares, joining seven tiles to eight already played tiles.) While a safe and effective and inexpensive TB drug goes begging, a potentially dangerous TB drug was just approved by the FDA. Johnson & Johnson’s new drug designed to treat multi-drug-resistant tuberculosis, benaquline, was given accelerated approval despite the FDA’s findings that the drug comes with a fivefold greater risk of death compared to a placebo. FDA usually requires three-stage testing process, but benaquline was approved after only the first two phases, with promises that they’d continue more tests later. Why approve a drug that has a dramatically increased risk of death when a drug that has been around for half a decade can do the same thing more safely? Because the old drug costs pennies a day, while the new one is extremely expensive. Big Pharma is all about Big Money, and not about treating the millions of patients, most of them very poor, who are transmitting and then dying from the disease all over the world. If we finally do get the worldwide pandemic that health experts have worried about for decades, and hundreds of millions of people die, it may very well be TB, not the flu. The people who run the drug system (whether in the pharmaceutical industry or the FDA) and are keeping oxyphenbutazone off the market may then lose loved ones and regret what they did—but it will be too late. Action Alert! Contact the FDA, with a copy to Congress, and insist that a way be found around present bureaucratic barriers that prevent oxyphenbutazone from being reviewed for possible approval for drug-resistant tuberculosis. The threat of a worldwide pandemic in drug-resistant TB is very real. This is an urgent matter and there is no time to lose. Just because oxyphenbutazone is off-patent and therefore of little interest to drug companies and hard to study is no excuse. Send your message today!

The Irradiation Loophole

ANH-USA — Wed, 09 Jan 2013 02:00:00 +0000

Is this the FDA’s idea of food safety? Action Alert! The Food Safety Modernization Act (FSMA) became law in 2010. We, along with other consumer groups, were able to block some of the worst provisions of the proposed bill, but it was still flawed legislation as passed. The basic problem is that every time food safety problems emerge, the government gives a pass to the big industrial farms where the problems originate. The FDA has just proposed two new rules as part of the act’s implementation. Not surprisingly they appear to have been heavily influenced by the same special interests responsible for many of the dangers to our foods: the chemical, radiology, and meat industries are exempted, all in the name of food safety. The first of the rules concerns standards for raw agricultural commodities (RAC). The reasoning behind the exclusive focus on raw foods is that processed food is less likely to be contaminated. Never mind how unhealthy processed food is so long as the food is not contaminated. The FDA’s big idea seems to be irradiation. Irradiated foods are exempted because FDA believes nuked, sterile food is safer. The agency is apparently not concerned with what happens to the food’s nutritional value or whether the irradiation itself is safe. How many food producers, hoping to avoid burdensome and expensive compliance requirements, will simply irradiate their fruits and vegetables? With such onerous rules combined with this big loophole, the FDA is actively encouraging irradiation. There are many reasons irradiated food is bad for us. There are no federal standards for safe levels of radiation in sterilized food, and research indicates a wide range of problems in animals that eat irradiated food, including chromosomal abnormalities, a rare form of cancer, and even premature death. Irradiating food can kill bacteria from filthy CAFOs and processing plants, but it cannot address the other unhealthy conditions found there. Irradiation may also dramatically change flavor, odor, and texture of food, in addition to nutritional value. But that really doesn’t matter, since the FDA no longer considers slaughtered meat to be a raw agricultural commodity. The meat industry is exempted from the new rules. So it actually doesn’t matter how unhealthy or disease-ridden CAFOs (confined animal feeding operations) become. The FDA conveniently decided not to worry about contamination from chemical hazards either, instead focusing exclusively on microbiological contamination. Since chemical contamination includes pesticides, cleaning compounds, etc., this is a big omission. The FDA reasons that its current regulatory framework to monitor these contaminants is sufficient, and says “illnesses attributable to chemical hazards are rare.” Illnesses from pesticides, cleaning compounds, and other chemical contaminants are rare? Well, that’s the FDA’s worldview, because if they acknowledged the problem they might have to do something about it. This exclusive focus on biological hazards (and the exclusion of standards for chemical and radiological hazards) is essentially a harmonization with an international standard called Codex. As we reported last month, Codex guidelines can and do have a major influence on US policy, and may have more influence in the future. Fortunately, ANH-USA, working with a large coalition, was able to help win acceptance of the Tester amendment, ensuring protections in the law for smaller farms. The second proposed FDA rule amends the agency’s Current Good Manufacturing Practices (CGMPs) guidelines by creating hazards analysis requirements and risk-based protections with lots of detailed record keeping. If you are wondering what this means, you are in good company. Firms will presumably have to hire former FDA employees at high fees to figure out what the requirements really mean and to be sure they are satisfying the regulators. There is, of course, no guarantee that the FDA has the resources to review any of the mountain of new paperwork. There is no question that the proposed rule gives the FDA more power. What the FDA currently calls “recommendations” for food production now become requirements. Because of your efforts when the food safety legislation was being passed, the new rules do not apply to family farms with revenues under $500,000. That was a major improvement. It may also not apply to other small producers if they are below $250,000 in revenues or don’t exceed $500,000 in revenues and sell half their food to consumers or retailers. Is a firm that sells both retail and wholesale a retailer for purpose of this rule? If you are a small firm, you may have to hire a lawyer to figure that one out. Action Alert! Contact FDA today and tell them their food safety approach is wrong. Nuking all our food is not the solution. It will just make things worse. Ask them to address the real dangers of our food system: CAFOs, unsafe industrial farming practices, reliance on genetically modified foods, and pesticide, herbicide, and antibiotic overuse.

Does Being Famous Get You Worse Medical Care?

ANH-USA — Wed, 09 Jan 2013 01:00:50 +0000

Former president George H.W. Bush’s hospital stay has been extended for more than a month because he had a cough or needed to “build energy.” What’s the real story? It isn’t always better to be famous. Doctors would almost never put an average patient in the hospital for a cough. Hospitals are not only ridiculously expensive and uncomfortable places; they are also exceedingly dangerous places. But if you are famous, the doctors can’t do enough for you, and in a world where medical treatment is the number one cause of death, that can lead to an earlier—not a later—death. This isn’t anything new. George Washington died because one doctor after another wanted to have a hand in treating what seems to have been a common viral infection. Each of them decided to “bleed” him, which was established practice in the day. After so many bleedings, he seems to have died of blood loss. Doctors aren’t quite this crude today, but they have many more dangerous tools at their disposal and many more ways in which to be over-aggressive in their treatment. President Bush has been in a hospital in Houston since November 23 for what was described as mild bronchitis. Since then he has had a “series of setbacks” according to a Bush spokesperson, Jim McGrath, with “a stubborn fever that won’t go away.” Currently he is in a “guarded condition” on a liquids-only diet. The “stubborn fever” is a very likely indication that he developed an infection in the hospital—a not-uncommon occurrence. The CDC estimates that 1.7 million people contract hospital infections each year—with 100,000 of them dying—at a cost of $45 billion a year. The CDC’s estimate is a huge underrepresentation, because (as we reported in 2009) fully eighteen percent of Americans say they or a loved one have acquired a dangerous infection following a medical procedure. That’s more than 56 million people. Outside of the CDC’s estimate, there are very few statistics (and very little transparency) regarding hospital care. There is no nationally mandated reporting; in fact, the reporting is often left to the discretion of the hospitals themselves. Poisoning, primarily from FDA-approved drugs, kills more people than car accidents—and this is data does come from the hospitals! How can Mr. Bush possibly “build up energy” in a mainstream hospital setting? Hospital food, overseen by Registered Dietitians, often consists of poor quality, highly processed foods that are high in sodium. Perhaps that’s why his doctors have him on a liquids-only diet, but the truth is that a synthetic liquid diet is sure to leave out key nutrients. We just don’t know enough to make a really nourishing artificial food. And what about rest? How can anyone get any rest in a hospital with all the noise and bright lights and constant comings and goings? Melatonin is one of our immune system’s key components, but who can circulate any melatonin with the lights on all the time? Want to get rid of a stubborn infection? Try some natural approaches instead: colloidal silver, the world’s oldest antibiotic; garlic, intravenous vitamin C, the herbs Cat’s Claw and Artemisia, and hyperbaric oxygen therapy all fight bacterial infections. Vitamin D has strong antiviral properties, and is critical to all our immune functions. We wish President Bush the best but cannot be optimistic so long as he receives the “best” care a hospital can offer—which is actually some of the “worst” care on the planet.

Frankenfish Could Be Close to Approval!

ANH-USA — Wed, 09 Jan 2013 00:00:51 +0000

The FDA’s flawed environmental assessment deliberately omitted critical information. Action Alert! On December 21, under cover of the holidays and hoping for as little media attention as possible, the FDA released an environmental assessment (EA) of AquaBounty’s “AquAdvantage” transgenic salmon, which we dubbed “Frankenfish” back in 2010). This assessment stated that the genetically engineered salmon would have “no significant impact” on the US environment—thus pushing the fish one step closer to approval. The FDA’s analysis, however, is deeply flawed in that it looked only at the impact it might have on the US environment. The FDA is not required to look at environmental impacts in foreign nations, even though the salmon is created in Canada and raised in Panama! That’s why an EA is insufficient and a full Environmental Impact Statement (EIS) is necessary: an EIS is far more detailed, and takes into account environmental impacts beyond US borders, exactly what the government wanted to avoid. AquaBounty claims that the company’s process for raising GE fish is safer than traditional aquaculture, yet documents released by the Canadian government show that a new strain of Infectious Salmon Anemia (ISA), the deadly “flu” that has been devastating fish stocks around the world, contaminated the company’s Prince Edward Island facility in 2009. This caused AquaBounty to cull much of its broodstock and lose its “fish health” certificate from the Canadian authorities (thus barring exports of the fish); the company only regained the certificate in November 2011. None of this information was included in the FDA’s report. The EA, which relies heavily on data provided by AquaBounty, also fails to mention the fact that up to five percent of the fish may be fertile, when we were assured they would all be sterile. The genetically engineered fish could easily escape into local waterways and wreak havoc on the ecosystem and our already-threatened wild salmon populations. The timing of the report is also suspect beyond the holiday cover. The EA is dated May 2012, but it was released after the election, so it could not affect the president’s electability (GMOs are controversial among Obama’s political base). The report’s failure to include vital health and environmental information flies in the face of the White House’s 2009 science integrity memo pledging that political officials would not suppress scientific findings and conclusions. The FDA’s assessment was released in support of AquaBounty’s NDA, or New Drug Application, for the salmon. Most people don’t realize that there is no regulatory process for approving genetically engineered animals in the US; this is most likely so they can avoid extensive scrutiny. Although the review of GE animals is shoehorned into the New Drug Application process, the oversight of GE animals is insufficient and never even looks at the impact on the health of humans who eat GE animals. The EA also ignores the urging of more than 40 members of Congress to conduct a more rigorous review of the salmon’s environmental and health safety. The public filed nearly 400,000 comments demanding FDA reject this application, and 300 environmental, consumer, health and animal welfare organizations, salmon and fishing groups and associations, food companies, and chefs and restaurants filed joint statements with FDA opposing approval of the salmon. Public outcry apparently means nothing in today’s crony capitalist environment! Approval of the salmon will open the floodgates for other genetically engineered animals, including pigs and cows. AquaBounty’s largest shareholder—the company that bailed them out of their financial woes—is the biotech company Intrexon. Its senior VP and head of animal sciences is Thomas Kasser, a twenty-year veteran of Monsanto Choice Genetics, where he worked on recombinant bovine growth hormone (rBGH); he is also a former vice-president of Pfizer and McDonalds. Action Alert! We now have a 60-day comment period, after which FDA must respond to the comments and issue a final disposition. Tell FDA to conduct a more rigorous review of environmental and health safety, and halt any approval process until concerns over risks, transparency, and oversight have been fully satisfied. Explain the safety concerns with GMO foods in general and this “Frankenfish” in particular. Take action now!

The World Didn’t End, but Access to Some Supplements Might. Act Now!

ANH-USA — Fri, 21 Dec 2012 21:59:16 +0000

Special interests and huge international
corporations are making the FDA and Codex
work for them—but together, you and
ANH-USA can stop them. Donate now!

Recently, we asked for your help to raise $30,000. We told you about the disastrous New Dietary Ingredients draft guidance, how it threatens 29,000 supplements currently on the market, and how we need funds for educational costs and legal fees to fight it. Hundreds have already responded generously—but we still need your help!

We also shared how ANH-USA proudly represented you at the recent Codex meeting in Germany. Codex Alimentarius is a collection of internationally adopted food standards and guidelines that “supporters” (read: Big Business and Pharma) hope will “facilitate international trade” (read: make it easier to make more money with less consumer choice).

So, how do the NDI guidance & Codex threaten your access to quality supplements? Think of it as a domino effect:

The EU has adopted absurd limits on supplements—either banning them or allowing for sale only dosage strengths so low as to be completely ineffective. Codex could easily follow suit, potentially impacting 185 countries.
The FDA tends to follow the EU. In fact, the current NDI draft guidance mirrors the EU’s Novel Food Regulation.
The FDA’s NDI guidance could restrict access to your favorite supplements. Even the thousands of supplements marketed prior to 1994 are in danger, as the FDA requires an unreasonable amount of evidence to prove an ingredient isn’t “new” (marketed after 1994).

In our increasingly interconnected world, the fight to protect supplements is going global. What happens abroad today could affect your access to supplements tomorrow. That’s why we can’t take a single day off—please act now, before it’s too late.

Any size gift makes a huge difference—$5, $50, $500,
or more! Your donation will be 100% tax deductible—
every single penny goes straight to the Natural Health
Alliance Foundation, the charity that supports ANH-
USA’s legal and educational projects.

With your donation comes our promise: all of us at ANH-USA will do everything we can to protect your access to natural health in 2013. Happy holidays!

Carly and I Need Your Help!

ANH-USA — Wed, 19 Dec 2012 14:04:50 +0000

Thousands of nutritional supplements could be taken off the market— but you can fight back. Make your tax-deductible donation today!

I’d like to introduce you to a friend of mine—she’s my personal inspiration to protect our dietary supplements from the FDA’s New Dietary Ingredient(NDI) guidance.

Carly Lockman is a Chicagoan, a mother-to-be, and works in the holistic nutrition field. For years, she suffered not only from hyperthyroidism, but from the endless doctor’s bills and pills that were supposed to cure her. Finally, after a punishing radiation “treatment,” Carly turned to natural health solutions: a diet of whole, organic foods; a toxin-free lifestyle; regular exercise; and nutritional supplements.

Carly is now disease-free and living life to the fullest, and is excited to share the benefits of a holistic lifestyle with her clients, her loved ones, and soon, her daughter.

But the way of life that you, Carly, and I value so highly is under attack: thousands of our nutritional supplements may soon disappear because of the FDA’s NDI guidance.

In June, the FDA revoked the first draft of its NDI guidance. This was a huge victory, and was only possible because you stood up to them with ANH-USA. Thank you! But that was one battle in what will be a long war. We now have a seat at FDA’s table representing consumers as the agency begins the revision process—though we fear the next draft could be even worse.

Your donation today, no matter how small, will allow us to continue the fight against the FDA’s anti-supplement bias.

ANH-USA works hard every day to protect your supplements from threats like these. We are the only consumer advocacy group in talks with the FDA over the next draft of the NDI guidance, because we are one of the few organizations that work on behalf of everyday people like you and Carly. Not Big Business, Big Pharma, or other special interests.

And we’re ready to take the fight to anyone, anywhere! As you read this, my boss and ANH-USA’s executive director, Gretchen DuBeau, is representing you in Germany at the meeting of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU). She’s there to protect the right of American consumers to truly wholesome foods and high-quality supplements.

But protecting access to supplements is expensive. In 2013, ANH-USA will meet with the FDA to monitor its revision of the NDI guidance and will alert you when the second draft guidance is issued (so you can tell the FDA exactly what you think). We will also submit formal comments on behalf of the public and commission an independent legal analysis—but this will easily cost tens of thousands of dollars.

This is why we need your help:

Our goal is to raise $30,000 by December 31 for research, education, and action on the next NDI draft guidance. Will you make a tax-deductible gift today? Every dollar makes a difference.

Thank you so much for your support! Our work would not be possible without it.

P.S.: As an extra bonus, through December 31, your qualifying donation earns you a reusable tote bag, BPA-free water bottle, picnic blanket, or yoga mat that lets you proudly show off your support for ANH-USA. Please make your gift today!

EU Quashes Free Speech in Health Claims

ANH-USA — Tue, 18 Dec 2012 23:04:48 +0000

Europe has rejected 95% of the health and nutrition claims under review. What does this mean for us? The European Food Safety Authority (EFSA) evaluated 2,037 health claims—that is, statements that a nutrient or food contributes to or has a positive impact on a particular health condition—and authorized the use of only 241 of them. Most of the ones accepted were related to structure or function claims, such as “calcium contributes to normal muscle function.” As we’ve reported previously, structure/function claims are statements that describe the role of a nutrient or dietary ingredient as it affects normal structure or function in humans. In the US, structure/function claims like “calcium builds strong bones” or “vitamin D boosts immune system function” are allowed, but one cannot legally cite the science showing that vitamin D prevents and treats the flu. The flu is considered a disease, so this is forbidden. With the EU’s list, we see the same censorship at work, only more so. Claims that were rejected as being unacceptable included “(Cow’s) Milk products help support dental health. (Cow’s) Milk helps support the normal and healthy development of teeth. (Cow’s) Milk contributes to dental health” and “Vitamin D is needed for the normal/proper function of the thyroid. Vitamin D is needed for the proper regulation of blood calcium levels.” Food and supplement products in the European Union must comply with this permitted list of health claims for use on food packaging, or else face prosecution for misleading marketing. The EU created its Nutrition and Health Claims Regulation in 2006 to ensure that consumers were not misled by “unsubstantiated, exaggerated, or untruthful claims.” But we would ask: aren’t they misleading consumers into thinking that there aren’t benefits from food or dietary supplements, when the science overwhelmingly shows the opposite to be true? For example, we have the Harvard study that found a bioflavonoid in apples called rutin prevents clotting, and the studies indicating that medium chain triglycerides in coconut oil can prevent Alzheimer’s. But none of that would impress the EU unless a big company got behind it. As ANH-International’s executive director, Robert Verkerk, noted on the BBC’s You and Yours program, some rules prevent you from claiming that fruit is beneficial, or that a diet rich in vegetables helps regulate body weight. Dr. Verkerk also said that big food companies, with their deep pockets, could play the system and claim health benefits for their food simply by inserting a small amount of an approved ingredient into a product. As constitutional rights attorney Jonathan Emord points out, accurate health claims are a matter of safety. For example, the FDA would permit the following structure/function supplement claim: “This product supports healthy ranges of [blood sugar, blood pressure, or cholesterol]. But that doesn’t say enough. Someone on insulin should have clear information that a supplement could lower their blood sugar, in order to avoid a dangerous nutrient-drug interaction. How will this new European regime of banning and forbidding affect American citizens? Potentially quite a lot. The EU is doing what the FDA wants to do and would do if it could. As it is, our system is not far behind the EU’s. For example, the current NDI draft guidance mirrors the EU’s Novel Food Regulation. The EU and the US have similar ways of determining “safe” upper levels of nutrient intake. And, as we reported last week, the EU is taking their anti-free speech position worldwide, insisting during Codex meetings that no language should be allowed indicating that food prevents disease, even in the case of nutrient deficiency illnesses. This free speech issue is echoed in the POM Wonderful case, where the FDA attempted to bar a claim about the health benefits of pomegranate juice unless the company met a standard applicable only to drugs. As Jonathan Emord points out in a recent blog post, POM Wonderful’s court win could be reversed a month from now: the FTC has appealed the May 2012 ruling that POM’s structure/function claims don’t need to be supported by two random-controlled human clinical trials (RCTs). The final decision is expected on January 18. If the FTC wins, the two-RCT requirement could take effect in a little over a month. What’s wrong with these trials? As we have noted many times, they are too expensive for most companies because the products ingredients are natural and cannot be patented. Without patents, there is no way to cover the exorbitant cost. The FTC and FDA know all this: they are just protecting drug companies, which in the case of the FDA pay much of the agency’s budget. This is a reminder why the Free Speech About Science Act (FSAS) is so important. It will enable food and supplement companies to cite scientific evidence of benefits. It will ensure that free speech about science will be preserved, even while regulators and politicians such as Senator Dick Durbin and Congressman Henry Waxman try to bring EU regulations to the US.

Readers’ Corner: It’s a Drug When Big Pharma Wants It to Be a Drug

ANH-USA — Tue, 18 Dec 2012 22:02:04 +0000

A medication at the center of a recent court ruling turns out to be a completely natural substance. Earlier this month we reported on a court decision about free speech issues surrounding the promotion of off-label uses of an FDA-approved drug called Xyrem.

Jonathan V. Wright, MD, writes:

Re your December 4 article on Xyrem, I thought you would be interested to know that Xyrem is actually not a patent medicine (“drug”). It is entirely identical to the natural substance gamma-hydroxybutyric acid (GHB). In the US, it was once used as a sedative. In Europe, it is still used safely as a sedative during childbirth. In the US, by contrast, it was categorized as a Schedule I controlled substance (like heroin) by act of Congress in 2000, principally on the grounds that it had been used for date rape. Alcohol, also associated with date rape, was not included in the same act.

As a controlled substance, GHB cannot be compounded by a compounding pharmacy. It can, however, be sold as Xyrem. Because it is federally approved, it is able to be manufactured by only one company, is sold retail by only one pharmacy, costs (as of 2011) $1,750 per prescription—and is covered by insurance.

Thank you, Dr. Wright. Clearly a “drug” is anything the pharmaceutical industry wants it to be, and the federal government is their willing accomplice.

ANH-USA: The Year in Review

ANH-USA — Tue, 18 Dec 2012 22:00:32 +0000

As we come to the end of our 20th anniversary year, we celebrate some major victories, thanks to your grassroots activism.

Dietetics Monopoly

ANH-USA, with our nutritionist allies, managed to defeat six of the nine state bills that were introduced this year at the instigation of the Academy of Nutrition and Dietetics, formerly the American Dietetic Association (AND/ADA): California, Colorado, Hawaii, Indiana, Virginia, and West Virginia. All the bills posed significant threats to nutritionists, health coaches, and consumers in those states. We tapped into our network of grassroots activists, coordinated email and letter writing campaigns, and supported coalition building among nutritionists and activists. Our efforts continue in New Jersey and New York, both of which have pending AND/ADA legislation, and we continue to monitor state legislatures for newly introduced AND/ADA bills. Thank you so much for your strong work to defeat these bills! In Illinois, with our allies, we took a proactive step to help reshape the regulatory framework, and this month we were able to get the Illinois legislature to replace the state’s ten-year-old monopolistic dietitian law. The new law will recognize for licensure advance degree and credentialed nutritionists instead of just Registered Dietitians, and will provide greater protections for acupuncturists, health food stores, small businesses, and individuals to provide nutrition advice so long as the information is not an individual prescription to address a specific individual’s health condition. The Academy of Nutrition and Dietetics is headquartered in Illinois—so this win in their home state counts all the more. It is the first step in a long battle to turn back monopolistic dietitian laws.

Informed Vaccine Choice

Informed choice is crucial in weighing whether to get vaccinated or not. But people are often denied any choice with regard to vaccines, as many vaccines are mandated at the state level. Arizona proposed legislation that would have made it more difficult for parents to invoke the medical exemption for their children; we opposed it, and thanks to our activist network, the bill did not pass. We also supported legislation in Virginia that would remove the mandate that school children be inoculated with the human papillomavirus (HPV) vaccine, as well as a bill in West Virginia that would prohibit all forms of mercury in vaccines. Unfortunately, neither bill passed, but the Virginia bill will be picked up again in 2013.

Sen. Durbin's PDUFA Amendment

Senator Dick Durbin (D-IL) offered an amendment to the Prescription Drug User Fee Act (PDUFA) requiring that supplement companies register all their products—and the ingredients they contain—with the FDA. Our concern with the legislation was that it would have created a slippery slope toward a supplement pre-approval system—similar to the European Union regulatory system, where only those vitamins and minerals on the approved list may be used in food supplements, and often in very limited amounts. For example, if a supplement contains more beta carotene than is present in half of a large carrot, it is banned in the EU. Our reader members sent over 100,000 messages to Congress in less than 24 hours, and the amendment was defeated by a vote of 77 to 20!

NDI Guidance

ANH-USA strongly opposed the FDA’s draft guidance on New Dietary Ingredients (NDI) that threatened to remove 29,000 dietary supplements from the market. Even though it was not supposed to be a final guidance, and despite the fact that FDA never addressed the significant concerns the public sent in, the agency had been preemptively using the draft guidance as the basis for enforcement action against multiple supplement companies. We worked closely with the Appropriations Committee, which controls FDA funding, to secure report language censuring the FDA for prematurely enforcing the NDI draft guidance and insisting that FDA withdraw the guidance, evaluate the significant concerns that had been expressed, and reissue a revised draft. Two days later, FDA acknowledged in a meeting with Senators Hatch and Harkin that the NDI draft guidance required substantial revision and agreed to rewrite the guidance, which will then be open for public comment once again. This is a startling reversal from the FDA’s previous position, where they refused the very same request from the same Members of Congress. We had requested the withdrawal and revision of the guidance in our original petition to the FDA, and it represents significant progress, even though there is no specific timeline as to when the agency will reissue the draft guidance or what changes will be made. For the moment, the focus of the agency has apparently shifted to creating a list of supplements that would be free from FDA review, an area that is loaded with minefields for natural health supporters, and where we are very actively involved.

Dangerous GMO Riders

With our allies, we managed to stall the GMO riders in the Farm Bill and the Appropriations Bill. The fight now depends on the fiscal cliff package.

Amicus Brief on Raw Almonds

ANH continues to fight for your access to healthy whole foods. In 2007, the USDA introduced a “pasteurization” rule that applies even to raw, organic almonds. One allowed method, microwaving the nuts, fell by the wayside. Of the five remaining methods allowed, three would cook the nuts, one would cause a marked reduction in nutrient content, and the last would use a possible carcinogen on them. Raw and organic almond farmers filed suit against the USDA. ANH-USA submitted an Amicus brief in support of the plaintiffs. (An amicus curiae, Latin for “friend of the court,” is an outsider who provides information to assist the court in making its decision). Our brief will allow ANH-USA to raise issues that may not be brought up by the plaintiffs during regular trial proceedings. It will also let us take a stand against the USDA and call attention to the public policy and public health implications of the almond rule.

TMB’s Lawsuit against Dr. Burzynski Dismissed

Dr. Stanislaw Burzynski and his legal team won against all odds. The Texas Medical Board’s case against Dr. Burzynski was thrown out, creating another victory for alternative and integrative doctors. Dr. Burzynski is an integrative physician and biochemist practicing in Texas who developed (with his own money) a nontoxic gene-targeted cancer therapy called antineoplastons that has been shown to help cure some of the most “incurable” forms of terminal cancer.

We can’t find words to thank you—our readers, our members, our friends—for your continued support. You write the letters, make the phone calls, and send the messages to legislators and other decision-makers that time and again make all the difference and lead to victories. You sustain us financially, and you spread the word about our important work on behalf of natural health consumers and practitioners. Together we make important strides each year, and we are profoundly grateful.

Codex Committee: “You Can’t Tell People that Food Prevents Disease!”

ANH-USA — Tue, 11 Dec 2012 21:39:50 +0000

Not even nutrient-related disease! Our executive director’s gripping report from the front lines. As we discussed last week, ANH-USA represented US consumers at the international Codex Committee on Nutrition and Foods for Special Dietary Uses, which met last week in Germany. Our executive director, Gretchen DuBeau, reports that the committee made a number of decisions that may well affect natural health in the US. Here in the US, we have been debating various issues concerning natural health: Will we retain access to a wide variety of dietary supplements in high-nutrient-level dosages? Will we be able to access nutritious, healthy foods, or will selection and quality diminish because of industry or government control? Will we finally achieve mandatory labeling for GMOs? We naturally think that, if we are able to convince our policymakers, our rights will be protected. But we could be wrong. We have to keep a close eye on what happens overseas too. Codex, which was established by the World Health Organization (WHO) and the UN Food and Agriculture Organization (FAO), is creating international guidelines for member nations to follow. And while these guidelines are supposed to be voluntary, it is conceivable that our country’s food policies could be overridden by international trade law. At the very least, the wrong international guidelines won’t make it easier to keep the right ones here. One of the most significant outcomes from this meeting would have the effect of squelching free speech even further. In relation to principles underlying food fortification for the prevention of diet-related illness, the committee members emphasized that language indicating that food prevents disease is forbidden and they are opposed to claims that may “mislead”—even if the claim is true. Happily, the US delegation disagreed, and said that while the US has similar policies about food claims, by definition the nutrients in food prevent nutrient-related diseases! The Botswana delegation agreed with us, pointing out that iodine prevents goiter, so therefore nutrients do prevent disease, yet Botswana nevertheless reinforced the ban. This is at the heart of ANH’s work. We are here to educate consumers about the role that food, supplements (including nutraceuticals), and lifestyle play in optimizing health. And now we are seeing the beginning of international policy preventing health claims related to natural health products and foods. It’s difficult to educate consumers when international leaders are forbidding the discussion! In another extremely troubling decision, the Codex Committee adopted extremely low Nutrient Reference Values for labeling purposes—that is, the intake levels of essential nutrients deemed adequate to meet most people’s minimal nutritional needs. They are roughly equivalent to our “Recommended Dietary Allowances,” in that RDAs indicate the daily dietary intake level of a nutrient considered sufficient by the Food and Nutrition Board to meet the requirements of 97.5% of healthy individuals in each life-stage and gender group. These new NRVs are far too low to be effective at preventing disease, according to most natural health experts, with even higher nutrient values needed to optimize health—though it was stressed that the actual values weren’t important because they are “just for labeling purposes.” The committee also adopted single values—what some supposed “average healthy person” might need. And of course that doesn’t work! Children, young people, men, women (with different needs if pregnant), the elderly, and people with a multitude of nutrient deficiencies or excesses, food sensitivities, dietary needs, and illnesses—each would need a very different dosage. So we would advocate a range of values, which can take into account bioindividuality—the “systems biology” approach that considers the great variability in individuals’ genetic backgrounds. Also under discussion were NRVs associated with reduced incidence of non-communicable diet-related diseases, or NRVs-NCD. Regarding those, the committee said, “Governments are encouraged to use the NRVs-NCD, or alternatively, consider the suitability of the general principles below, including the level of evidence required... in establishing their own reference values for labeling purposes for nutrients associated with diet-related non-communicable diseases.” In other words: member countries should adopt these standards precisely, or at least follow our guidelines if you need to tweak them to your needs. Did you see that phrase, “including the level of evidence required”? At least here we find an upside: the committee proposed a broader scientific standard than the one it had been using previously. Instead of the “gold standard” of random-controlled trials (RCTs), both WHO and FAO now use something called the GRADE system, which takes into consideration all levels of evidence, including clinical, giving more weight to evidence that is more conclusive. And Codex is inclined to agree with this broader standard. This is extremely positive, as natural health products rarely have patent protection and therefore cannot afford hundreds of millions of dollars for RCTs, but may have an abundance of clinical evidence. Of course, everyone’s big question is harmonization on supplements—that is, whether the US will accept the limits Codex creates for supplements (in terms of dosages and product availability). Unfortunately, there’s no easy answer to that one. The US delegation made it clear that our country intends to stay flexible—to create our own standards and use our own science, indicating no intention to harmonize at this time. Legally, we are not bound to harmonize. But we are subject to World Trade Organization (WTO) sanctions should conflicting national policy creates trade disputes. This is unlikely to be an issue, but there have already been conflicts. For example, in 1985 the European Union enacted a ban on the production and importation of meat derived from animals treated with growth-promoting hormones. In 1989, the EU banned the import of US beef produced with growth-promoting hormones, dramatically reducing beef exports to the EU. In 1996, the US claimed that the EU ban adversely affected trade and because their standards exceeded those set by Codex, the WTO should intervene. It did, and a WTO panel ruled in the US’s favor, allowing the US to begin collecting tariffs on $116.8 million worth of imports from the EU—the amount that it lost each year due to the ban. In other words, while a country may not be obligated to adopt a Codex standard into domestic law, international trade pressures, especially from powerful countries, could create pressure to do so. This is a particular threat when it comes to dietary supplements. Although the US may be able to maintain access to high level nutrients in its supplements, much of the rest of the world will not. And the weight of a standard accepted by 185 countries is almost certain to give determined anti-supplement legislators like Senator Dick Durbin (D-IL) and Congressman Henry Waxman (D-CA) reasons, at some point, to introduce a new bill to harmonize. Of further concern is the fact that Codex is creating principles for food fortification—adding folic acid or calcium to food—which, as we’ve reported, can in some cases be dangerous. For example, it is dangerous to fortify with calcium without any of the essential co-factors. In addition, this is a band-aid approach to treating nutrient deficiencies instead of focusing on the real problem. We need to address farming practices that are destroying the nutrient content of soil and leading to less nutritious food. What about GMOs (genetically modified organisms)? Europe is not friendly to GMO, so could we gain some ground there? If this meeting is any indication, the answer is likely to be No. The issue of banning GMOs in children’s cereals was quickly dismissed because of a “lack of science” supporting the claim that GMOs are dangerous. We noted that there were dozens of “experts” in the room ready to support GMO. Here again we have the international trade dispute problem to consider: If state bills requiring GMO labeling were to pass, and it eventually became federal law, and Codex prohibited such labeling, there would absolutely be a WTO dispute and the international standard would be hard to beat. This meeting revealed the usual problem of the infiltration of special interests. This threatens to outweigh what appears to be positive intent on the part of many participating in the process. The underlying—and most relevant—question is, “Who benefits from harmonized standards on everything from infant formula to fortification of foods?” Answer: the largest companies in the world. Their interests are represented here, but the consumers of the world are not. The tagline on many Codex documents is “safe, good food for everyone,” but the point that was stressed over and over again at this meeting is that “we are here to facilitate trade.” As Codex continues through its creation and approval process, it is taking on a life of its own that, despite the current intent of the US to maintain independence, may meet us at our front door and demand entrance.

Reports that Backscatter Machines Are Being Removed from Airports False

ANH-USA — Tue, 11 Dec 2012 21:30:46 +0000

And even worse scanners may be coming. As we reported earlier this year, the full-body x-ray scanners used in airports are so dangerous that the European Union has banned them. The backscatter machines being used by the Transportation Security Administration (TSA) emit “low” levels of ionizing radiation with an impact that is 10 to 20 times higher than the manufacturer’s calculations. They are a cancer risk. There have been press reports about these dangerous machines being removed. But you have to read the fine print. The backscatter machines are being taken out of the busier airports not because of documented safety concerns, but because they are slowing down the line! Many people opt out of a scan from the backscatter machines because of privacy concerns (the scanners display a nude image of each person scanned to TSA officers in a nearby room), choosing instead to undergo the physical screening instead. And this is causing long waits at some airports. The machines aren’t going away, however: they’re merely being moved to smaller, less-busy airports. So the health risks (not to mention the invasion of privacy) will be just as great as before—but perhaps harder to avoid. Note that there are two types of airport scanning machines that use radiation (here are pictures so you can tell them apart at a glance). The dangerous backscatter machines use a “low”-intensity x-ray beam that is directed over the surface of the body. Millimeter wave scan machines use radiation waves that are not dissimilar to microwaves. Experts are generally much more concerned with x-ray radiation then with millimeter waves, although we don’t know enough about the latter. The Electronic Privacy Information Center (EPIC) is suing the Department of Human Services over cancer clusters possibly linked to radiation exposure among TSA employees. EPIC is alleging that the agency failed to issue employees dosimeters—safety devices that could assess the level of radiation exposure—and mischaracterized the findings of the National Institute of Standards and Technology, stating that NIST “affirmed the safety” of full body scanners when in fact a Johns Hopkins University study revealed that radiation zones around body scanners could exceed the General Public Dose Limit. The TSA’s administrator, John Pistole, was invited to testify at a hearing of the Subcommittee on Aviation on “How Best to Improve Our Nation’s Airport Passenger Security System through Commonsense Solutions.” Pistole refused to appear, saying that the Transportation and Infrastructure Committee has no jurisdiction” over the TSA, so no representative would be present at the meeting. Subcommittee on Aviation chair Rep. Tom Petri (R-WI) said the agency’s “absence today demonstrates why the public is so frustrated with the TSA.” In response to both the health and the privacy issues posed by the backscatter machines, two new scanners are also making an appearance. One, being implemented at Boston’s Logan Airport, is equipped with Automatic Target Recognition software that will display a cartoonish image of the passenger—a rougher outline of a passenger's body that’s similar to the A-shaped silhouette of Gumby, the green clay cartoon character. A second body scanner has been developed by In-Q-tel, a quasi-governmental security company founded in 1999 “by a group of private citizens at the request of the Director of the CIA and the support of the US Congress.” It’s a laser-based molecular scanner that looks for trace elements of chemical compounds and radiation. The technology is portable, light, and quick, which means that it may appear in more places than just the airport—such as movie theaters, sports venues, etc.—anyplace large groups of people might congregate. The laser scanner can be fired from 164 feet (50 meters) away, and is able to get a great deal of information from you—including traces of drugs or gun powder on your clothes. According to security expert and attorney Mychal Wilson, “They can also detect drugs, alcohol, and your breakfast, lunch, and dinner. Even your adrenaline level will be available for government analysis. Everything about your body will be available to the government and logged into a database.” The health risks of the technology are still unknown. But Xichen Zhang, professor of lasers and optics at the University of Rochester, states that the system uses waveforms that can pass through clothes, luggage, etc., causing a minor reaction in whatever they hit. This is scary stuff indeed.

GMO Riders Could Be Back in “Fiscal Cliff” Funding Package

ANH-USA — Tue, 04 Dec 2012 20:00:04 +0000

A must-pass funding bill may include dangerous genetic engineering provisions. Action Alert! The Budget Control Act of 2011 goes into affect at midnight on December 31. That is the bill already passed that raises taxes and cuts the budget. Congress does not like this scenario, so it is working on an omnibus 2013 Appropriations Bill that will address tax and spending cuts before January 1. Even though no bill has yet been introduced, if Congress and President Obama reach agreement, the bill will be rushed through. Unfortunately, we have received word from sources on Capitol Hill that the GMO bills that previously were attached to the Agriculture Appropriations Bill and the Farm Bill could be part of this package. And because it’s a must-pass funding package, any GMO rider that is included will likely become law. These are the same GMO riders we told you about last July. Section 733 of the Agriculture Appropriations Bill (the so-called “Farmer Assurance Provision,” though one might just as well call it the “Monsanto Protection Act”) would strip federal courts of the authority to halt the sale or planting of illegal, potentially hazardous GMO crops—even if a court has told them to stop—while USDA is still assessing potential hazards. The Secretary of Agriculture must, under this provision, grant any farm operator or producer upon request a temporary permit allowing GMO crops to be planted or cultivated, even if a court has called a halt to it until an Environmental Impact Statement is completed. This rider will almost certainly be included in the omnibus appropriations bill. The second rider, which had been attached to the Farm Bill, would outlaw any review of GE crop impacts based on the National Environmental Policy Act, the Endangered Species Act, or any other environmental law. And no agency other than USDA would be allowed to provide analysis. Even worse, even if negative information were allowed, this would have no affect on the approval of GMO crops. It is less likely that it will be included in the funding bill, but entirely possible. The biotechnology lobby (Monsanto et al.) is pushing these riders hard to get them folded into the last-minute funding package. Moreover, Sen. Inouye, chair of the Senate Appropriations Committee, still supports the riders, even though the other senators on his committee have already expressed opposition. While their lobbyists are working on Congress, the biotech industry continues to enforce their seed patents at the expense of small farmers. For example, DuPont is sending former police officers across North America to prevent farmers from saving the seeds from the harvest to replant the next year—despite this being a traditional farming practice. DuPont considers such practices illegal, a threat to patent protection, and in violation of their sales contract. Whether DuPont and other biotech companies will be allowed to continue taking direct action against farmers is a matter that will be considered by the Supreme Court. Action Alert! Congressman Peter DeFazio (D-OR) is circulating a Dear Colleague letter in the House of Representatives opposing the GMO provisions. Please contact your senators and representative immediately. Take Action Now!

Ask your representative to sign the Dear Colleague letter.

Ask your senators to oppose the biotech rider if the language finds its way in the fiscal package.

Free Speech Court Ruling Could Have Far-reaching Consequences

ANH-USA — Tue, 04 Dec 2012 18:00:22 +0000

Big Pharma seems to be the winner. But this could open the door for natural health companies to cite truthful science about supplements. As we have noted before, the FDA thinks that “misbranding” can mean making a completely true statement about a product but without FDA permission. The FDA is definitely not a fan of free speech. A cherry producer who cites peer-reviewed scientific research from prestigious universities on the health benefits of cherries would, in FDA-speak, have engaged in “false” and actionable “misbranding” which suddenly turns the cherries into what FDA calls “drugs.” It’s because of this “misbranding” threat that supplement producers are not allowed to discuss scientific research on the efficacy of their products. The FDA also contends that “misbranding” includes marketing or promoting a drug or medical advice for any use other than what the FDA approved it for. In other words, if a drug approved to treat narcolepsy also works as a treatment for insomnia or fibromyalgia (as a drug called Xyrem allegedly does), the drug company and its representatives cannot promote the drug’s off-label uses. Doctors are free to prescribe a drug for any use they wish, but the drug company can’t tell them about such alternative uses. A former sales rep for the company that made Xyrem was caught on tape doing just that—promoting its off-label uses to doctors. He was convicted by a jury, but the sales rep appealed the conviction, arguing that his right to free speech under the First Amendment was being illegally restricted. And yesterday, a federal Court of Appeals agreed that the ban on so-called off-label marketing violated the sales rep’s freedom of speech. One of the judges wrote, “The government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA [the federal Food, Drug, and Cosmetic Act] for speech promoting the lawful, off-label use of an FDA-approved drug.” The government is likely to appeal the appellate court ruling, and the case could find its way to the Supreme Court. While most accounts are chalking this up as just another win for the drug companies, this ruling could open the door for natural health proponents. Considering that the previous understanding was that anyone can speak openly about the truthful-but-non-FDA approved health benefits of a supplement—anyone except the company selling the product and its representatives, that is—this ruling could have huge implications for supplement companies and how they can communicate to practitioners, and perhaps even more broadly, to consumers. If a drug company sales rep can promote non-FDA-approved uses for drugs, particularly as a means for encouraging doctors to prescribe them to their patients, then might not the same freedom of speech allow supplement companies to tell practitioners about the science behind their product? We should note that this ruling was on literal speech—what the rep said verbally—and didn’t specifically apply to written materials. But previous free speech rulings interpret the issue more broadly as “freedom of communication.” And even if a court finds it doesn’t apply to written materials, it would likely still apply to what health food store employees can tell you about a supplement—which is, in itself, a huge opening. Maybe the government would have to stop trying to entrap health food store employees. The Pharmaceutical Research and Manufacturers of America (PhRMA), a trade group representing the drug companies, was of course pleased with the decision. A spokesperson says saying PhRMA “believes that truthful and non-misleading communication between biopharmaceutical companies and healthcare professionals is good for patients, because it facilitates the exchange of up-to-date and scientifically accurate information about new treatments.” Now remove the word “biopharmaceutical” in the above quote and put “supplement” in its place. The sword that is our freedom of speech cuts both ways!

Will New Federal Rules Save Health Savings Accounts?

ANH-USA — Tue, 04 Dec 2012 17:00:23 +0000

Let’s hope so, since many of us depend on them for natural health expenditures. As we have discussed before, HSAs are tied to high-deductible plans—and it originally appeared that high-deductible plans would be doomed under the Patient Protection and Affordable Care Act (PPACA), colloquially known as ObamaCare. But apparently the Department of Health and Human Services (HHS), in response to grassroots activists like you, and to the surprise of legislators who voted for the Act, has found a way to allow them to incorporate high-deductible plans—and thus to save HSAs. Based on the actuarial analysis, some high-deductible plans may qualify as bronze level plans on the insurance exchange. (These are insurance plans where the patient pays 40% of the bill, and the insurance plan picking up 60%.) This is a very big surprise, and a welcome one. Does it mean that HSAs are in the clear? Not necessarily. Even though our HSAs seem to be allowed, it will be hard to get insurance companies to offer them when 80% of the premium must be paid out for healthcare expenses. So HSAs aren’t out of the woods yet—we’ll have to wait and see how everything works out when the rules are fully implemented, and of course we’ll keep you posted. But for now, we are guardedly optimistic. Unfortunately, the word about FSAs isn’t as good. As we reported previously, Flexible Spending Arrangements allow employees to be reimbursed for medical expenses. FSAs are usually funded through voluntary salary reduction agreements with one’s employer. No employment or federal income taxes are deducted from the employee’s contribution, and the employer may also contribute. Under the new rules, there is a $2,500 limit on annual contributions to FSAs. This limit will disproportionately affect families who get CAM treatments. Last week the government also issued its proposed rules for wellness incentive programs. These programs were already established under HIPAA (the Health Insurance Portability and Accountability Act, which mainly deals with patient privacy issues), but they have increased weight under ObamaCare. There are two types of wellness programs:

In a participatory wellness program, participation is enough to get the reward (lower premiums, more benefits) or to avoid paying a penalty. The program may include gym benefits, diagnostic testing (blood sugar, BMI, etc.).
In a health-contingent wellness program, the reward or penalty is tied to certain outcomes. Tobacco cessation programs are tied to actual cessation of smoking. Diagnostic testing programs are tied to meeting required levels—such as a body mass index (BMI) of lower than 200—or else participating in a program that will help lower BMI in order to get the reward or avoid the penalty.

It is the health-contingent wellness programs that many fear are ripe for abuse and discrimination. A key factor in healthcare reform was to prevent discrimination against individuals based on preexisting conditions. There is now a legitimate concern that health-contingent wellness programs could be used by employers to discriminate unfairly against employees. Obese patients can be charged a higher healthcare premium with many wellness programs—even though the government’s close ties to industry actually perpetuates the obesity epidemic. For example, the sugar industry, in a strategic marketing campaign, manipulated scientists and government officials to overlook health problems caused by the overconsumption of sugar. In many other instances too, the government is disseminating the wrong nutrition information, and patients who follow it are further penalized by having to pay higher premiums. A larger concern with workplace wellness incentive programs is that companies may coerce their employees to follow specific guidelines to meet mainstream medicine’s idea of “health”—for example, pressuring employees to take statin drugs to reduce cholesterol, or blood pressure medications that may weaken the heart over the long run, or to undergo invasive tests, some with high radiation. If the employee chooses to opt out of the plan, they may get penalized by having to pay a greater share of their health insurance payment—up to 30% more under PPACA. Such an approach was already proposed in Chicago. Fortunately, the newly issued rules do provide some possible opt-outs for natural health consumers, although they may be hard to use in practice. Employees may request a reasonable alternative wellness program based on the recommendation of their personal physician (even an integrative physician), a program that is better suited to promoting the individual’s health. Even so, all of this is encouraging employers to delve way too deeply into our personal decisions. Proposed rules were also issued for essential health benefits (EHB). PPACA mandates that health plans offered in the individual and small group markets offer “essential health benefits” that must be equal in scope to benefits offered by a “typical employer plan”—but this will vary from state to state, and whether or not CAM therapies will be covered depends entirely on the “typical plan” selected by the state. Some states are already choosing their EHB package; states like California and Washington have decided to include acupuncture as one of services covered under the EHBs, though whether other states will follow suit is anyone’s guess. Other states have not yet begun the process. EHBs are supposed to be decided by the end of 2012, so it is unclear what these states plan to do. If a state does not decide on its EHB package, the federal government will select a default benchmark plan for the state. Then there’s the issue of health insurance exchanges—competitive health insurance marketplaces that are supposed to offer a choice of health plans, establish common packages and pricing structures, and provide information to help consumers better understand the options available to them. Under PPACA, each state is supposed to set up its own insurance exchange. If they fail to do so, the federal government has the authority to step in and operate an exchange in those states. PPACA is over 2,000 pages long and was created in a rush, so some big glitches are emerging. It now appears that in states which choose not to set up their own exchanges (and that may be as many as half), the federal government is legally barred from providing subsidies. This may have been intended to encourage the states to set up exchanges, but if so, that idea has backfired, especially in light of the Supreme Court decision allowing states to opt out. One good piece of news is that, according to our source at HHS, even if states decide not to set up an exchange, they do not forfeit their rights to choose their own EHB package—and that is very good news indeed for integrative medicine patients. You can follow states’ progress in choosing EHBs here. Meanwhile, the big open question about PPACA remains its effect on employment. The benefits required for a minimum wage employee with a family are almost as large as the minimum wage itself. This has already led to firms replacing employees with machines—for example, replacing employees with electronic teller machines in drug stores. In addition, the penalty for employers not offering healthcare is computed based on full-time workers (another drafting glitch), so many firms are considering moving to more part-time employees. The Congressional Budget Office also estimates that PPACA covers two million fewer Americans than originally predicted.

The Latest on Alzheimer’s

ANH-USA — Tue, 27 Nov 2012 21:00:51 +0000

Behind a dangerous new test approved by the FDA is a new drug by the same company. Meanwhile, new research offers better natural solutions. The US Food and Drug Administration has approved a new test from Eli Lilly & Co that detects the presence of proteins in the brain that have been connected to Alzheimer’s disease. The test uses a $1,600-per-dose radioactive chemical called Amyvid that tags clumps of a sticky substance called amyloid proteins. Some of these proteins may become prions, that is, misfolded proteins that become toxic, but other amyloid proteins are relatively harmless. The chemical is then detected using a PET scan, a brain imaging technique. In the October 12 issue of his Second Opinion newsletter, Dr. Robert J. Rowen warns that people who do not show signs of dementia should avoid this test—it’s not reliable. Some 20% of cognitively healthy older adults have been found in autopsies to have large quantities of amyloid in the brain, according to Denise Park, director of the Center for Vital Longevity at the University of Texas at Dallas. So why inject radioactive chemicals into the brain (of all places) for an unreliable test? The FDA initially rejected Amyvid after an advisory panel had concerns that doctors would not be able to read and interpret scans correctly. But rather than changing the technology itself, Eli Lilly just came up with better ways to train doctors to use the test. The test remained the same, and FDA rubber-stamped its approval. It joins a growing number of imaging agents for Alzheimer’s, which together are estimated to have a global market of between $1 and 5 billion. The FDA does not seem concerned that misreading the test results—or the test itself being inaccurate one-fifth of the time, which is even worse—means more patients will be misdiagnosed, and even more people will be scared into taking Alzheimer’s drugs. Not coincidentally, we think, Eli Lilly has developed a new drug to go along with their new test. It’s called solanezumab, and it’s currently undergoing clinical trials. The drug was a failure in two trials of late-stage Alzheimer’s, but new data suggests it may slow memory loss by 42% in patients with a mild form of Alzheimer’s, which is why their early-detection test is so important: it’s only on those patients that their new drug may help at all! There are some pesky side effects from the drug—such as cases of chest pain (angina) caused by not enough oxygen-rich blood going to the heart. Apparently that’s considered a fair trade-off for a 42% chance that your memory loss will be slowed a bit. We wish we understood how the FDA can get away with thinking like this. Scientists are also studying the cancer drug bexarotene for treatment for Alzheimer’s. If it’s successful, it’s sure to bring a big financial windfall. Just ignore the side effects associated with bexarotene: severe allergic reactions, pancreatitis, blood problems, infections, swelling, and even major birth defects. The great shame of it all is that there are many safe and effective natural treatments for Alzheimer’s that are being ignored by the mainstream medical establishment. For example, a new study from the University Medical Center in Amsterdam found superb results in patients with mild Alzheimer’s using a combination of supplement ingredients: fish oil high in DHA; PhosChol; and Uridine-300, a supplement that reduces abnormal nerve firing patterns in seizure, ADHD and ADD, autism and toxic CNS neuropathy, as well as organic brain syndrome. These primary ingredients were combined with small amounts of selenium, B vitamins, and alpha-tocopherol. You may recall our article on the positive effects of coconut oil on the progression of Alzheimer’s, as well as our article on the power of nattokinase and niacinamide (a B vitamin) to halt and even reverse memory loss. Last year, University of Kentucky researchers showed how important vitamin D is for the brain—they believe it may help brains stay “greased” during middle age. For cases where damage has already been done, fish oil shows tremendous ability to help rebuild the brain, though hyperbaric oxygen therapy (HBOT) remains the best treatment for brain injuries. Also avoid toxic chemicals such as BPA, which has been shown to impair memory and alter brain structure.

Why You Should Care About Codex: Separating Fact from Fiction

ANH-USA — Tue, 27 Nov 2012 21:00:46 +0000

Next week, ANH-USA will travel to Germany to represent YOU at the next Codex meeting. Here’s what to expect. The Alliance for Natural Health USA has been selected to represent US consumers at the international Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU), which will meet December 3–7 in Germany. The Codex Alimentarius (Latin for “Food Code”) is a collection of internationally adopted food standards, guidelines, codes of practice, and other recommendations which supporters hope will become a global standard and also facilitate international trade. The CCNFSDU studies specific nutritional problems and advises the Codex Commission on general nutrition issues. They also develop guidelines for foods and supplements for special dietary uses, so having a seat at the table and being able to directly convey your concerns is a significant step forward for our consumer advocacy organization. The Codex Commission’s decisions are far-reaching, and generally work to the advantage of the world’s most powerful countries and powerful industry members. Smaller countries and companies can easily get shut out of the process. We represent only the interests of the consumer, particularly the natural health community. The Commission, through their various committees, addresses acceptable levels of pesticide residues, the amount of gluten allowed in gluten-free foods, GMOs and GMO labeling, infant formula, supplements, and contaminants in food. Regular Pulse readers will recall that we have some major concerns with the US adopting an international standard, particularly since the Commission usually follows the European Union, and the EU has adopted absurd limits on supplements—either banning them or allowing for sale only dosage strengths so low as to be completely ineffective. Here are some of our concerns—and things we hope to help change by taking an active role in Codex discussions now and in the future:

Genetically engineered plants and animals being globally accepted with little to no scientific vetting;
Standards concerning “healthy food production systems” (i.e., organics) being dumbed down, and the approval of synthetic additives and processing aids in “organic” food, to better suit profit-driven corporate interests;
The acceptance of dangerously high pesticide residue levels;
Banning useful supplements or setting excessively low maximum daily doses based on scientifically flawed risk-assessment methods;
Creating rules that may force foods or supplements into the drug category; and
Creating an international requirement for hyper-expensive drug-style clinical trials before one can share any health information about a food or supplement.

December’s meeting will mainly be about supplements, recommended daily allowances (and the criteria for determining them), and the enrichment of foods (adding vitamins or minerals to them). Contrary to many Internet rumors, governments are not required to adopt Codex standards, so the effects of any Codex decisions are never immediate and are drawn out over many years. In the US, the process for adopting Codex standards can occur either through legislation or through the regulatory process—and of course citizens have a say in that! In fact, Congress has passed a law stating that Codex standards will not supersede domestic laws. At the same time, however, Congress has passed other legislation stating that federal agencies must or should consider some Codex standards as part of the regulatory process—which may incorporate Codex into US standards with little fanfare. For example:

The Food Quality Protection Act states that FDA must consider Codex maximum levels when establishing tolerance for pesticide chemical residue in or on food. If the agency decides to depart from the Codex standards, they have to provide an explanation for public comment.
Under the Animal Drug Availability Act, in establishing tolerance levels of drugs, the FDA may consider and rely on Codex standards.
The FDA Food Safety Modernization Act (which we reported on extensively) required the FDA to provide recommendations on whether and how US should harmonize with Codex requirements. This opens the door towards much greater harmonization with Codex standards. Fortunately, ANH-USA secured a big victory by exempting dietary supplements from this provision.

Harmonizing US standards with Codex is worrisome, and we are pleased to be able to participate in the CCNFSDU’s decision-making process. We will report back after the meeting, and will keep you updated as we represent your concerns on the international stage and work to protect your rights.

Texas Medical Board’s Lawsuit against CAM Cancer Pioneer Dismissed!!

ANH-USA — Tue, 27 Nov 2012 19:00:00 +0000

The state’s attack on Dr. Stanislaw Burzynski is finally over. And some states are even passing laws that protect integrative physicians. As we reported last November, Stanislaw Burzynski, MD, PhD, is a physician and biochemist practicing in Texas who developed (with his own money) a nontoxic gene-targeted cancer therapy called antineoplastons. This therapy has been shown to help cure some of the most “incurable” forms of terminal cancer. In the 1980s, the Texas Medical Board (TMB) charged this caring and pioneering doctor with breaking a law that didn’t actually exist, and tried to revoke his medical license. Numerous investigations later—including an appearance before the Texas Supreme Court—found no violation of any law or standard of care. The FDA, the pharmaceutical industry, and the National Cancer Institute, knowing how promising Dr. Burzynski’s therapy was proving to be, tried to duplicate his invention, then tried to steal his patents—but failed. Despite the fact that two informal medical board settlement panels found that Dr. Burzynski was acting within the standard of care, the TMB refused to drop the case and, earlier this year, made another attempt to revoke Dr. Burzynski’s medical license. Had the Board been successful, it would have resulted in the closure of the Burzynski clinic, the abandonment of all his patients, and the end of any possibility of antineoplastons gaining FDA-approval. The actions of the Texas Board have been nothing short of disgraceful and illustrate some of the worst problems of today’s special-interest-driven medicine. A week before trial was scheduled to take place last April, administrative law judges (ALJ) dismissed most of the charges against the doctor. This forced the TMB to reevaluate, and it eventually agreed to dismiss the entire case. On November 19, judges from the Texas State Office of Administrative Hearings dismissed the TMB’s case against Dr. Burzynski for novel off-label use of combination gene-targeted therapy. Rick Jaffe, Dr. Burzynki’s attorney, pointed to an important recent change in Texas law. In the previous legislative session, the Texas legislature stripped the TMB of its ability to summarily overturn the findings of the ALJ, and Dr. Burzynki’s case was one of the first to come under this new statute. The Board was thus forced to abide by the ALJ’s ruling. A stunning documentary on Dr. Burzynski’s fight has won numerous awards worldwide. While there have been some exciting breakthroughs in cancer research lately, Dr. Burzynski is truly on the cutting edge—and this ruling might provide some room for other doctors in Texas to pursue similar treatments. Unfortunately, this is not the case elsewhere. In most states, the ALJ provides findings, but the medical board is free to disregard them. This is especially problematic because state medical boards are historically biased against integrative medicine. Even when they are forced by the legislature to accept complementary and alternative medical practices (CAM), they still show their bias by targeting and harassing CAM doctors. The good news is that some states are introducing and passing legislation to protect CAM physicians. Although many of these laws hold CAM doctors to a more demanding standard than conventional doctors, especially in regard to informed consent and harm to the patient, it is a step in the right direction. For example, in California, Dr. Robert Jay Rowen received a complaint threatening his license from the widow of a cancer patient. The patient had stage 4 colon cancer and his oncologist had given up on chemotherapy. In an email, Dr. Rowen told us, “I did NOT promise anything at all, except to do the best I could to assist his immune system and hopefully improve the quality of his life. He was actually referred to me for IV vitamin C and integrative therapies [oxidation treatment]. The couple specifically requested these from me. And, the wife signed all the informed consents as witness to her husband!” While his physical condition improved temporarily, he chose not to return citing a desire to attend a clinic that took insurance. So, he eventually died. Four months later Dr. Rowen discovered that his widow had filed a complaint with the state medical board alleging abandonment and negligence. Fortunately, Dr. Rowen had himself helped to pass a California statute protecting integrative physicians so long as informed consent is given and there is a “reasonable” basis for the CAM therapy. Dr. Rowen invited the California medical board to look into the case:

I was called in for an “interview” with a senior investigator and a seasoned cardiologist who does professional questioning at these interviews. I will admit I was treated with dignity and respect. I was questioned on ALL my oxidation methods, the science and rationale, since I did them all with this patient, including direct intravenous gas administration. I was questioned on the supplements, on informed consent, and even charting and signing off on notes….

Then [the investigators] got a chance to review a case with an identical cancer that I was simultaneously treating. This patient was 20 years older (76), and his colon cancer, with huge [metastases] to the liver, was terminal. He had only a few weeks (at best) to live….The board’s cardiologist looked at the scans and blood tests I showed him that proved a 100% remission of terminal end-stage cancer, and shook his head side to side, exclaiming, “That’s just unheard of!”

Fortunately, the case was closed—in Dr. Rowen’s favor. This would probably not have occurred without the protections provided by the California CAM statute. It’s especially significant since this was one of the first times that oxidation treatment was reviewed by a major state, and accepted as a reasonable integrative treatment.

Nonprofit Medicine: Is Government About to Throw It under the Bus?

ANH-USA — Tue, 20 Nov 2012 20:00:32 +0000

Unfortunately, that appears to be the case—unless we do something about it. Action Alert! Who controls healthcare? We wish we could say it was consumers, but they have less and less of a voice. Actually, healthcare today is controlled by three entities: government, for-profit businesses, and nonprofits—and before long, the first two may muscle out the third. Should those of us following a natural health approach worry about this? Yes, definitely—for two reasons. First, conventional medicine has wandered far from the old ideal of being a caring profession, but that perspective is more likely to be rediscovered in a nonprofit setting than in one controlled by government or by for-profits. Second, having different kinds of healthcare providers increases our options and reduces the chance of having one-size-fits-all medicine forced on us. How much nonprofit medicine is there now? A lot. Fully 62% of hospitals are nonprofit (20% are government-run and the rest are for-profits), as are 30% of nursing homes, 17% of home healthcare agencies, and so on. The medical practices that President Obama has praised as role models that others should emulate are nonprofit. Yet President Obama is trying to undercut nonprofit medicine. And so are the Republicans. They are both doing it at a time when the donations to nonprofit medicine, decimated by the Crash of ’08, have still not recovered—and at a time when states and localities are upping taxes on nonprofits to try to reduce their deficits. Presidents Bush and Obama decided to bail out auto companies and Wall Street. So why try to tear down the whole nonprofit sector at the same time? That sector represents about 11% of the economy; it employs 13.5 million people, about 10% of the workforce. Is their work—devoted to the general welfare, typically done with lower pay and benefits than in either government or business—less important than the auto workers or Wall Streeters? The president famously said, “These aren’t games we are playing here. Folks are out of work.” Exactly—and they’re out of work in the charitable sector too, where we really need them working. First let’s look at Obama on nonprofits in general, then the Republicans. Then we’ll come back to nonprofit medicine. President Obama seemed to be praising charities in his Democratic Convention acceptance speech. He said, “We know that churches and charities can often make more of a difference than a poverty program alone.” But look at that more closely, especially the words “often” and “more.” The president was really saying that charities do not always make a difference and if they do it is by adding to what government is already doing. That was actually pretty dismissive. Most studies show that nonprofit social agencies are much more effective than government agencies, whether it is rehabbing drug addicts or delivering medicine to the poor. Furthermore, charities offer diversity. They are a laboratory of ideas and approaches, something that the government can never be. They also represent people-to-people solutions, the democratic ideal in action. Earlier, the president had proposed a sharp curtailment in the ability of single people with incomes over $200,000 or families with incomes over $250,000 to take a tax deduction on charitable gifts. He proposed this several times, but most recently as a way to pay for his proposed 2011 jobs stimulus bill. And this reduction in the charitable deduction would be on top of another reduction (the “Pease limitation”) that was already scheduled to come back with the end of the Bush tax cuts. In 2009, Obama said, “I think it [reducing the charitable deduction] is a realistic way for us to raise some revenue from people who have benefited enormously over the last several years.” But that doesn’t make any sense. Taking away the charitable deduction doesn’t penalize the rich; it penalizes the charities and the people being served by the charities. If the rich don’t give, they will end up with more money, not less. They do not suffer at all. Obama’s budget director at the time, Peter Orszag, seemed to acknowledge this—that it was the charities, not the big donors, who would suffer under this proposal—when he said that charities should be willing to make this sacrifice in return for more people getting health insurance under the Patient Protection and Affordable Care Act (“ObamaCare”). But this didn’t make any sense either. First, yanking the charitable tax deduction was not part of the president’s plan to finance broader healthcare. Second, reducing the deduction actually makes it harder to cover more people. This last point only requires a moment’s thought. If you want to cover more people, you need more doctors and nurses and clinics. In economic terms, if you increase demand, you should increase supply. Otherwise, people with the new health coverage still won’t be able to see a doctor, or they will have to wait for weeks and weeks, and prices will likely soar. This is not an abstract idea. It is already happening just this way in Massachusetts under RomneyCare. Newly covered people can’t find a doctor, and prices are rising so rapidly that the legislature has just passed a price control system (even though price controls almost always fail). So if you need more healthcare supply nationally, how does it help to take a hatchet to nonprofit healthcare providers? Obama also said that “there is very little evidence that this [cutting the charitable deduction] has a significant impact on charitable giving.” In fact, the evidence says the opposite, that for every 1% reduction in the deduction, gifts from wealthy people fall 1%. That kind of drop in charitable giving would be devastating for nonprofits. As David Harris, executive director of the American Jewish Committee, wrote to the president, “Most nonprofits derive 70 to 80 percent of their donations from a small proportion of their donors who are major givers. This proposal will deal a major blow.” Moreover, “taxing” major donors’ gifts would not even produce that much revenue for the government, only an estimated $54 billion a year. Compare that to the $300 billion in tax subsidies for health insurance or the overall budget deficit of $1.2 trillion. And let’s remember that charities would be expected to lose at least $54 billion and possibly much more. President Obama added that he doesn’t think it is fair that someone in the 35% tax bracket gets a 35% deduction while someone in the 28% tax bracket gets a 28% deduction. Before we get too worried about this, let’s remember that the employer tax deduction for health insurance works the same way—the higher your income, the bigger deduction you get—and involves much more money. But the president did nothing to change that in his healthcare legislation because unions did not want it changed. Also, speaking of fairness, why was the Affordable Care Act set up so that two families at the very same income level may receive government insurance subsidies that vary by $10,000 or even as much as $20,000? That doesn’t seem very fair. Furthermore, there is an easy fix to put everyone’s tax treatment for charitable giving on the exact same footing. Independent Sector, representing nonprofits as a whole, has proposed that “charitable contributions should not be included in an individual’s adjusted gross income [subject to tax].” This change from a tax deduction to a tax credit would treat everyone alike and produce a torrent of income for charities. If government doesn’t want to go that far, how about a tax credit for charities that directly help the needy? The president’s proposal to “tax” charities harder was first made when he had Democratic majorities in both the House and the Senate. Despite the majorities, it did not go anywhere. No one seemed to back it until Mitt Romney suddenly embraced it toward the end of the presidential campaign. But did he in fact embrace it? What Romney actually said was that tax rates for everyone, including the highest earners, should be reduced in order to help the economy. In return, he would propose to cap itemized deductions to a maximum of $17,000, $25,000, or $50,000 (all three figures were “examples” rather than proposals). Romney also wasn’t clear about whether the cap would apply to all itemized tax deductions (e.g., state income taxes, mortgage interest, and charitable gift deductions, but not health insurance deductions) or just some of them. Here is how an online reader reacted to the Romney proposal, which he assumed meant that charitable deductions would be cut. “[Let’s say you give 5% of your income to charity and I give none. The Romney plan] stops rewarding you for being a better human being than me and [instead] rewards me for being a jerk.” Regardless of what Romney actually intended, his remarks suddenly put the charitable deduction, part of the tax code since 1917, in grave peril. Only a few days after the 2008 presidential election, Democrats started pointing out that eliminating deductions was a Republican proposal, although they conveniently left out the part about cutting tax rates first. Republican House Speaker Boehner (R-OH) said he would be open to increasing government revenues, but not increasing tax rates. This was code for saying that tax deductions in general would be on the chopping block. Congressman and vice presidential candidate Paul Ryan said the same. And now Mitt Romney’s chief economic advisor, Glenn Hubbard, has also come out in favor of cutting deductions. How much nonprofit medicine will be wiped out if the charitable deduction falls? Potentially, quite a lot. It is hard to get firm figures on gifts for medicine, but as much as $32 billion may be going there, with about a third of that going to nonprofit hospitals. These hospitals are already endangered by threatened reimbursement cuts under the Affordable Care Act and many of them could be forced to close. How will low-wage earners benefit if they have “coverage” but don’t even have a hospital emergency room to go to? Will the charitable deduction survive? It depends on how the American public reacts. Do we want more charity, or less? Do we want social services, including medicine, to be provided only by government or for-profit businesses, or do we want a thriving nonprofit sector? Most countries do not have a thriving nonprofit sector. Europe does not have it, nor Japan. This has been a uniquely American phenomenon, recognized and encouraged by our tax laws. Now it is under attack. Whether that attack succeeds will make a big difference in the kind of country we are. If we care, and we should, we have to make our views known on Capitol Hill. It is possible that Congress will decide this in the next few weeks. We need to tell Congress not to throw charity under the bus! Please contact your senators and representative immediately.

Are Registered Dieticians “Practicing Medicine” Without a License?

ANH-USA — Tue, 20 Nov 2012 18:00:55 +0000

If so, it would be ironic, since RD groups are using similar laws to attack and suppress other, often better qualified nutritionists. The Georgia Board of Examiners of Licensed Dietitians met on February 17. According to the minutes, the meeting included six board members, the executive director for the Georgia Board of Nursing, and the assistant attorney general for the state of Georgia. On page 3 of the minutes we see that a board member, in reference to one of the board’s Dietitian Investigative Cases, suggested the investigator should pose as suffering from celiac disease or IBS, request counseling for those issues, and retrieve a copy of a brochure and any educational materials provided by the respondent. She also suggested the investigator should “present as having GI discomfort to see if the respondent attempts to assess the investigator’s symptoms,” which would be a legal violation. The motion was carried unanimously. This was nothing less than an undercover sting operation on a nutritionist, conducted with the full knowledge and cooperation of the Georgia attorney general’s office (AG). Said nutritionist was being investigated for practicing nutrition counseling without a license—because in Georgia, nutrition counseling is restricted to RDs, or Registered Dietitians, a trademarked term for members of the Academy of Nutrition and Dietetics, formerly the American Dietetic Association (AND/ADA). The board is clearly using entrapment methods to enforce its licensing statute, and to ensure that only RDs are allowed to give advice on nutrition-related diseases such as irritable bowel syndrome. They want a monopoly, and they will use state laws to make sure they have it. However, such sneaky tactics could backfire on them. Under the Georgia Medical Practice Act’s definition of the “practice of medicine,” only physicians are allowed offer “suggestion, recommendation, or prescribing of any form of treatment for the intended palliation, relief, or cure of any physical, mental, or functional ailment or defect of any person with the intention of receiving therefore, either directly or indirectly, any fee, gift or compensation whatsoever” (section 43-34-21). Although certain professions are exempted, such as nurses and midwives (section 43-34-22), there is no exemption for Registered Dietitians. Providing nutrition advice for “maintaining client health” is protected under the Georgia Dietetics Practice Act, but arguably this licensure law is in conflict with the medical practice act. Providing nutrition therapy for IBS and celiac disease, while important, is also very profitable. An Australian dietitian, for example, created a diet to treat celiac disease that avoids grain proteins and foods containing certain sugars called FODMAPS, an acronym for potentially tough-to-absorb molecules. Her low-gut-irritant diet spurred an $8.3 billion market, encouraging the likes of Abbott Laboratories to introduce products devoted to food intolerance. The AND/ADA seems to want to tap into that market in the US—and keep it the exclusive domain of RDs. Such a move could conflict, as it apparently does in Georgia, with state laws on the practice of medicine. State laws vary, of course, and while this would have to be analyzed on a state-by-state basis, the Federation of State Medical Boards (FSMB) is able to give us the big picture: their model law on the practice of medicine is used as standard language by many state boards, as we have reported previously. The FSMB’s definition of the practice of medicine includes “offering or undertaking to prevent or to diagnose, correct and/or treat in any manner...any disease, illness, pain, wound, fracture, infirmity, defect or abnormal physical or mental condition in any person” (section II). There are exemptions for those “practicing...any other of the healing arts in accord with and as provided by the laws of the jurisdiction.” But it would depend on how the states interpret “healing arts” in their own statute, or whether they even include it in the first place. Otherwise, “correcting or treating” diseases like IBS and celiac disease would certainly be the province of physicians only, and not RDs! This fierce battle for territory seems to occur among AND/ADA’s own members as well. For example, the Florida Dietetics and Nutrition Practice Council voted to deny licenses even to other Registered Dietitians simply because they were licensed in other states (specifically, New York and North Carolina). State dietetics boards can use licensure to recommend that individuals practicing nutrition counseling without the proper organization’s blessing—even nutritionists with advanced degrees and certifications from organizations with higher and more exacting standards than those of the AND/ADA—be legally prosecuted, with penalties that include severe fines and even jail time. Everything you say can and will be used against you when you testify before these boards! Nutrition practitioners and counselors may wish obtain our guide, What Every Practitioner Needs to Know: A Practitioner’s Guide to Protecting Your License and Your Practice from Medical Board and Other Government Action. It’s free when you join ANH-USA as an Integrative Community Member. To learn more, visit http://www.anh-usa.org/main-menu/take-action/join/.

Let’s Get the Boycott Rolling—Please Sign the Pledge

ANH-USA — Tue, 13 Nov 2012 21:00:08 +0000

And to paraphrase a famous Californian, “We’ll be back!” Sign the pledge. The opposition spent $45 million and narrowly defeated this citizen-driven initiative. If we are patient, we can still eventually win. California’s Label GMO proposition failed at the polls last week, the vote is currently 47.2% to 52.1%, ballots are still be counted due to the of millions of mail-in-votes California processes every election. Even though we lost to an overwhelmingly well-funded opposition led by Monsanto (they massively outspent Label GMO), the vote showed tremendous grassroots support for GMO labeling—with four million Californians voting in favor of the proposal. Here’s an irony for you: the Big Food industry claimed that the proposition would increase food costs. This was proved to be untrue, yet they were willing to spend $45 million to keep foods from being labeled. Clearly Monsanto et al. are terrified of the American public actually learning what’s in the food they buy every day. They must be really proud of their product! Even better, this campaign made genetically engineered foods a topic of state and national conversation, despite the opposition’s fear-based propaganda and personal attacks on integrative physicians. A luta continua, as the saying goes—the struggle will continue. We’ll continue to build on the momentum, and roll up our sleeves to get the proposition back on the ballot when we have another chance in 2014. But until then, there’s something we all can do: continue to boycott the companies that fought against your right to have your food properly labeled! In addition to Monsanto, DuPont, and Dow, you’re familiar with the big consumer food names:

Campbell Soup
Coca-Cola
ConAgra
Del Monte
General Mills
Hershey
Hormel
Kellogg
Kraft
Land O’ Lakes
Mars
McCormick
Nestlé
PepsiCo
Sara Lee
As well as with many other food manufacturers

But you may be shocked at some of the brands they own—brands you’d never think would be associated with the pro-GMO camp. Don’t let these companies get away with trying to eliminate your freedom of choice! See our full list of companies and brands that donated to defeat Prop 37, and please sign our pledge that you’ll keep up the boycott!

Washington’s Brand of Crony Capitalist Medicine

ANH-USA — Tue, 13 Nov 2012 19:00:00 +0000

Does AARP really speak for the elderly? Or the AMA for doctors? In Washington, AARP (the American Association of Retired Persons) is said to represent the interests of retirees in arguments about medicine. Their endorsement of President Obama’s Patient Protection and Affordable Care Act was mentioned reverently during the October 3rd presidential debate. Similarly, the AMA (American Medical Association) is said to represent the interests of doctors. But do these groups actually represent anyone other than their members? Is their support basically for sale? Consider AARP. It gets only about 20% of its revenue from its members. Over 50% comes from its medical insurance business where it has the largest share of “Medigap” policies, the policies that fill in the holes in traditional Medicare. When the administration sought AARP’s support for the Affordable Care Act, it promised to exempt Medigap policies from the requirement that insurers could not turn away people with preexisting conditions. Not only that, it also promised to exempt Medigap policies from rate review. (Ordinarily, health insurance companies must tell consumers when they want to increase insurance rates for individual or small group policies by an average of 10% or more.) In the end, Medigap was exempted from most of the law. If that weren’t enough, the Affordable Care Act targets Medicare Advantage plans run by other private insurers. If these do not survive, and we expect they won’t, seniors currently in these plans will fall back into traditional Medicare and need—you guessed it—Medigap coverage, the field that AARP dominates. Given these deals, South Carolina senator Jim DeMint may not be exaggerating when he calls the relationship between AARP and the White House “a protection racket.” He also alleges that AARP has engaged in a secret lobbying campaign to prevent Medigap reforms which would have saved 80% of of seniors enrolled an average of $415 a year. What about the AMA, then? Is it doing what it says it is doing in Washington—protecting the best interests of doctors? Perhaps not, if the dwindling number of doctors who are currently members is any indication. The word in Washington is that the administration assured AMA support for its legislation by 1) promising not to implement doctor reimbursement cuts in Medicare that had previously been written into law, and 2) threatening to pull the medical coding contracts with the US Department of Health and Human Services that constitute the largest share of the AMA’s income, estimated by one source to be $50–80 million. Have you noticed your doctor filling out a yellow code sheet indicating what services he or she has provided? That is a coding system run by the AMA and paid for by the government—and it is a monopoly. Have others tried to offer a competitive coding system? Yes, and a much better coding system at that. It is called the ABC system, which we reported on two years ago, but Health and Human Services has essentially blocked it from becoming competition for the AMA. No wonder Dr. Richard A. Armstrong says, “The AMA is a corporation in the business of selling and protecting its [coding system] income stream, not its doctor members.” (Read more about the ABC coding system in this article.) There are a lot of things wrong with American medicine today, especially its disregard for real prevention in the form of diet, supplements, and exercise in favor of toxic drugs and surgery. But much of the problem, in the final analysis, goes back to a crony capitalist system dominated by special interests and their allies in government. With the election over, it’s a good time to remember that crony capitalism permeates both parties, and we have a lot of work to do to keep medicine a “helping” profession with high ethics, not a place for special interests to get rich.

Medical Billing Codes—Will Nurses and Alternative Medicine Ever Get a Foot in the Door?

ANH-USA — Tue, 13 Nov 2012 18:00:55 +0000

Not if crony interests can stop it. But there are the highly respected ABC codes, which integrative practitioners can start using immediately. Two years ago we told you about how the world of medicine is run by billing codes—every hospital, doctor, and practitioner who accepts insurance or Medicare uses billing codes both for a record and for any reimbursement. Billing codes can also be used by researchers to track the effectiveness of various treatments. Would you be surprised to learn that the standard billing codes, set up by the American Medical Association, don’t include complementary or alternative medical (CAM) therapies? ABC Coding Solutions is one of the few billing code providers that offer codes for a full range of integrative practitioners and therapies as well as nursing and other services. In 1983, the government agreed to make the AMA’s codes the only ones allowed for Medicare billing, which means that alternative and integrative medical practitioners are completely squeezed out. Moreover, without the proper codes, it is harder to collect good data on the benefits of CAM—which may be the very reason that government and the AMA don’t want any alternative codes. This is just another example of crony capitalism at work. For more on the AMA’s cozy working relationship with the government, see this article. The Department of Health and Human Services (HHS) granted an exception to test ABC Codes in electronic healthcare transactions in 2003. Alaska Medicaid used ABC codes under this exception between 2004 and 2009 to process over 2 million claims and payment transactions in a behavioral health program. Alaska documented a cost savings of over 50% in using ABC codes rather than the AMA’s codes required for filing claims! HHS then asked the Centers for Medicare and Medicaid Services (CMS) to review ABC’s cost–benefit analysis quantifying these savings. CMS reported back that there was “no compelling data to have ABC codes added to the [standard] codes required for filing healthcare claims.” The CMS report was full of blatant errors, which ABC attempted to get them to correct, but HHS paid no attention. After this experience, ABC decided to abandon working with the government, after already spending $700,000 on lobbying. For now ABC Coding Solutions is working directly with practitioners to use the ABC billing codes in filing electronic claims with private insurers. “We found that nurses, counselors, chiropractors, and many other integrative health professionals are frequently not reimbursed by insurance companies. Without ABC codes, these professions are often reimbursed at the wrong rate and their payments are delayed,” explained Melinna Giannini, CEO of ABC Coding Solutions. This helps close the gap and allow some 2 million more healthcare professionals to get paid, by allowing practitioners to supplement conventional medical codes as they file electronic healthcare claims. Medicare is not likely to provide coverage for CAM services any time soon. Not even nurse practitioners and other advanced-practice nursing services are covered under Medicare. There is language in PPACA, the Patient Protection and Affordable Care Act, that would expand coverage to providers who are not MDs or DOs so long as those practitioners are acting within their scope of practice to provide benefits allowed by the insurance organization. However, Medicare disallows many services that are not managed by MDs, who don’t want competition from nurses, much less from integrative medicine. On the one hand, the government realizes that there are major cost savings to be had by allowing highly trained nurses to do more. On the other hand, the government and the American Medical Association are in a crony relationship. How this will shake out over time remains to be seen.

If GMOs Are So Great, Why Don’t They Want ’Em Advertised? Vote YES on Prop 37!

ANH-USA — Mon, 05 Nov 2012 21:00:14 +0000

California voters can help make the whole country healthier. Get out the news, and make sure everyone you know votes FOR this vital initiative! What once was supposed to be an easy win for consumers now is a dead heat. The fear-based propaganda of the exceedingly well-funded opposition can still be defeated—but ONLY if everyone gets out and votes in favor of California’s Proposition 37. The latest polls show us hanging on by the slimmest of margins: 45.1% versus 43.2%, with a whopping 11.6% still undecided. That means your California friends or relatives who haven’t yet made up their minds will shape the outcome—which will have a profound impact on the rest of the country’s health freedoms. Our sources report that the opposition is raising some last-minute funds—another $146,000 from Nestlé USA, $98,000 from Campbell’s Soup, and $95,000 from Unilever. So they probably don’t think they have it in the bag yet. And make no mistake, money talks in this media-driven campaign. The gap between their over $45 million versus the Right to Know Campaign’s meager $6 million has absolutely had an effect on the poll numbers—on September 23, a solid 61% said they would vote yes on Prop 37. It’s now an exceedingly close race because of the opposition’s war chest. They’ve used their money to spread lies and misrepresentations, and mount personal attacks on prominent Prop 37 supporters, including the highly respected integrative medicine pioneer Dr. Joseph A. Mercola. And they’ve managed to co-opt the editorial boards of many California newspapers, getting them to parrot the same two talking points—that it will increase the cost of labeling, and it will cause bounty hunter lawsuits similar to Prop 65—both of which we have completely disproved. But of course newspapers rely on advertising to stay alive—and the opposition’s many companies are some of their biggest advertisers. The Right to Know Campaign website debunks each of the myths spread by the opposition. Please make sure your friends and family in California know the FACTS before they vote tomorrow. (But send them this star-studded and very funny video first!)

Drug Manufacturer Trying to Cut off Ingredient Supply of the Cheaper, Nontoxic Version!

ANH-USA — Mon, 05 Nov 2012 20:00:21 +0000

Would you take a mass-marketed drug with toxic ingredients to prevent premature childbirth that costs 6,800% more than the ten-dollar compounded nontoxic version? You may not have a choice. Two Action Alerts! As we reported last year, KV Pharmaceutical manufactures Makena, a $13,800-per-pregnancy* synthetic form of progesterone prescribed for women with high-risk pregnancies to help prevent pre-term births. Compounding pharmacies have been making a safer and far less expensive version of the medicine for over a decade. Now KV has filed a complaint with the International Trade Commission (ITC) in an attempt to stop the supply of the ingredients for the compounded version. Since the entire supply of its active ingredient is imported, this move would effectively keep compounding pharmacies from making and selling this important medicine—and would completely eliminate the competition. One of the biggest factors is cost—the compounded version costs only $200 per pregnancy, less than one percent of the price that Makena is now selling for. Who knows what Makena will cost if it gets the monopoly it wants? Eliminating the compounded version would make the drug cost prohibitive for many, many women, and some of the available supply of the drug would be eliminated, which could cause a mother to lose her child. On top of that, sensitive women simply can’t take the commercial drug because it contains the toxic preservative benzyl alcohol. Benzyl alcohol has been linked to “gasping syndrome” in infants and, according to the CDC, has caused six neonatal deaths. Doctors can prescribe a compounded version of 17P without the benzyl alcohol, but if the ingredients are banned to compounders, only the version with the benzyl alcohol is left. As you may remember, two years ago, KV Pharmaceutical received “orphan drug” status for 17P, the successful progesterone-based drug, and immediately tried to ban the sale and production of the compounded version of 17P in an attempt to secure a monopoly. This caused an outpouring of grassroots protest, prompting FDA to officially state that compounding pharmacies could continue to provide 17P. In KV Pharmaceutical’s new attempt to eliminate compounded 17P, they’ve filed a section 337 case with the ITC asking that the active pharmaceutical ingredient, called API, be banned from import, creating a monopoly for the amount KV produces! The company is actually claiming that KV is the entire domestic industry for 17P, and that imports of 17P for use by compounding pharmacies will thus destroy the domestic industry. Just think about that for a second. “We are the only domestic industry for the ingredient”—meaning, in effect, that there is no domestic competition—“so other companies shouldn’t be allowed to receive the ingredients because it’s a threat to the industry”? Seriously? They’re not competition for you, but their competition hurts you? In addition, they are shamelessly trying to eliminate competition using Makena’s orphan drug status to support its actions, when the whole entire point of orphan drugs is to provide incentives to manufacture drugs because there is a shortage! In their complaint, KV accuses compounding pharmacies of having an “unlawful drug manufacturing and distribution enterprise...which proceeds under the fiction of individualized drug ‘compounding.’ ” They are essentially claiming there is no difference between compounding and drug manufacturing—an underhanded attempt to remove from the market compounded drugs that are exempt from the FDA drug approval process. Even worse, KV is riding the wave of the political backlash against compounding pharmacies due to the recent meningitis outbreak we reported on last month, and specifically mentions that tragic case as a major justification for its claim. Needless to say, if the ITC rules in favor of KV, it would set a terrible precedent for active pharmaceutical ingredients imported for other compounded drugs. The very latest twist in this is that KV Pharmaceutical has filed for bankruptcy protection. If KV wins their ITC suit banning the supply of API for 17P, then actually goes bankrupt, the drug could be lost to women forever. It is unlikely other pharmaceutical companies will try to spend the money to manufacture the drug, given its history. Compounding pharmacies are already regulated through state pharmacy boards. But now, after the meningitis debacle, Representative Ed Markey (D-MA)—despite his statements to those involved that he would hold off and work with others—has introduced legislation to give FDA greater enforcement powers over compounders, usurping state authority. Rep. Markey’s bill, HR 6584, would empower FDA to create a list of drugs that cannot be compounded. Who would set the standard? It would be at the FDA’s own discretion—which means that anything can be on the do-not-compound list. Furthermore, one of the ways the FDA can consider whether to include something on the list is if the drug is “reasonably likely to cause an adverse effect on safety and effectiveness.” Of course, FDA’s standard of safety and effectiveness is usually code for “double blind random-controlled studies”—which compounded drugs are specifically exempt from. Therefore any compounded drug could be deemed unsafe and ineffective and might therefore appear on the list—especially considering how strongly FDA is influenced by pharmaceutical interests. More to the point, it’s an inapplicable standard: compounded drugs are by definition medicine that is individualized for the needs of the patient. How can you run a drug trial on one person? Not only that, but compounded drugs are substantially similar to approved drugs or already have a USP monograph, so safety is demonstrably not an issue. The bill limits compounding to a per-patient prescription basis. This could completely eliminate “office use”—that is, when a practitioner administers a medicinal preparation directly to a patient, in his or her office or other treatment area, for the immediate treatment of a problem. In these instances a doctor would need to have a reserve supply on hand without a prescription. And pharmacies might need to start production on various compounded formulations in advance of a prescription—especially if they know they have a standing order on certain formulations. The registration and inspection exemptions for compounders would be eliminated if the FDA determines that a compounding pharmacy is in “in effect manufacturing.” What does that phrase actually mean? This, too, is for the FDA to decide. And it needs watching, since the FDA may try to use it as a club against compounding. We are working with key members of the Senate to ensure that any new legislation is not used as a back-door mechanism by Big Pharma to eliminate compounding pharmacies, which would secure a monopoly for commercial drugs. TWO Action Alerts!

The ITC is accepting public comment on the complaint, but only through this Friday. Please send your message today, and tell the ITC how important it is to protect the imported supply of API for 17P, and especially how important it is to preserve the compounded version, which is much more affordable for most women and may be significantly safer! Send your message to the ITC now!

Rep. Markey needs to understand his legislation is both superfluous and harmful. FDA can already move against compounding pharmacies that engage in activities more akin to drug manufacturing—as it appears was the case with the New England Compounding Center. Giving FDA greater authority won’t address the agency’s lack of resources and its inability to carry out its current mandate. Send your message to Rep. Markey now!

* Editor's Note: The initial price of Makena was $1,500 per dose, costing $30,000 over the course of a pregnancy, as the original version of this article noted. However, after the drug's debut, KV Pharmaceutical cut the price of their drug to $690 per dose, or $13,800 over the course of a pregnancy, still a far cry from the $10 per treatment the compounded version of 17P sells for. 11/27/2012

Groundbreaking Federal Study Proves Chelation Therapy Helps Cardiac Patients

ANH-USA — Mon, 05 Nov 2012 17:00:19 +0000

Chelation has long been favored by many integrative doctors. Now conventional cardiologists with vested interests in surgery and drugs are trying (and failing) to trash the study. What a surprise. TACT, the Trial to Assess Chelation Therapy, is a seven-year study funded by the NIH and carried out by university cardiologists and experienced chelation physicians from around the United States. This randomized, double-blind study compared patients who were treated with medication and intravenous chelation therapy to those receiving medication but no chelation. The results of the study, announced Saturday at the annual meeting of the American Heart Association, shows important improvement in patients who had previous heart attacks and were already under cardiology treatment—especially patients with diabetes. The group treated with chelation had fewer subsequent surgeries than those who received a placebo. The findings were unexpected by the conventional medical establishment which long fought the funding and implementation of the study and which tried to undermine it over the years. Not surprisingly, the study authors noted that additional research will needed to explain the precise mechanisms at work. How does chelation therapy work? As we reported in February, one method involves injecting into the patient’s bloodstream organic chemicals, which can bind and remove the heavy metals in the bloodstream (metals which are toxic to humans and interfere with various physiological functions). There are also oral or suppository supplements for chelation, and some foods are natural chelators (e.g., cilantro and chlorella). In the TACT trial, patients were given an organic molecule, EDTA (disodium ethylene diaminetetraacetic acid), which binds to (or “chelates”) the toxic minerals. Chelation therapy for heart and vascular disease has long been shown to be safe and statistically effective, and now the TACT trial has validated its promise. Immediately after the results were presented, five cardiologists were shown the study data on PowerPoint slides, and all agreed that a second clinical trial would be needed before making chelation for heart patients standard practice. Forbes called the study “highly controversial” and said that “most physicians and scientists have dismissed chelation therapy as lacking any evidence or rationale.” The Associated Press, in one of the most slanted, sneering, CAM-bashing pieces of “reporting” we’ve ever seen, called it “fringe medicine” despite the positive results of this government run-study. The study found that chelation reduced deaths from heart attacks by 18% (by over 39% for diabetics). Despite this, the New York Times stated that the study’s benefits “barely reached statistical significance” and claimed, without evidence, that “there were questions about the reliability of the study.” So mainstream medicine did all it could to sink this study but couldn’t do it. The study’s results speak for themselves.

Die Early with Sleeping Pills

ANH-USA — Mon, 29 Oct 2012 18:00:25 +0000

A new study shows prescription sleeping pills bring an increased risk of dying early—or getting cancer. So why is FDA rubber-stamping such dangerous drugs? Sleep deprivation is a serious issue. As many as 70 million Americans suffer from insomnia and other sleep disorders. Some 60 million prescriptions for sleeping pills—technically called hypnotic drugs—were filled in 2011 as compared to 47 million in 2006. Stress, an over-full lifestyle, poor diet, and especially the use of artificial light in the evening after going to bed, can all prevent sleep. As we reported earlier this year, lack of sleep makes you more likely to get sick, raises your risk of type 2 diabetes, high blood pressure, and obesity, and makes you more prone to depression. Some of the risks of sleeping pills are already well-documented: daytime drowsiness, headaches, nausea, dizziness, and addiction. But a new study published in the British Medical Journal says that people taking a prescription sleeping pill—even when taking fewer than eighteen pills per year—have nearly four times the mortality rate of those who don’t take the drugs. And patients who take higher doses of sleeping pills have a 35% increased cancer risk. This study was prompted by earlier studies showing that hypnotic drugs are often deadly when mixed with alcohol or other drugs, are linked to an increased risk of car accidents and falls, may raise risk of suicide, and may damage chromosomes in cells which could lead to cancer. What was significant about this study is that it was long-term, keeping track of 10,529 people who had at least one prescription for a sleeping pill between 2002 and 2007, compared with a control group. While the study doesn’t demonstrate causation, it did adjust for confounding factors such as age, smoking, weight, and other health conditions. So why is FDA approving such dangerous sleeping pills? For one thing, the clinical trials required for FDA approval may be inadequate when it comes to hypnotic drugs. Many people take non-benzodiazepine sedative hypnotics for years, even though most are approved for only short-term use and their safety and effectiveness were not evaluated beyond several weeks in clinical trials. (One exception is Lunesta, which was tested for up to six months, and its list of known side effects is terrifying.) Compare this to the FDA’s standard for supplements: the NDI draft guidance requires “25 years of widespread use” in order to meet the “history of safe use” standard, which must be met even for grandfathered supplements. (For more on grandfathered ingredients, see our article in this issue.) As the Life Extension Foundation points out, the safety testing required by FDA is wildly inappropriate for supplements, and is unnecessary for natural products with years of documented safe use. Yet despite their superb track record for safety, FDA and the media have cultivated an environment of fear around nutritional supplements—while maintaining a casual attitude toward dangerous (but approved) drugs. If you have a sleep problem, consider natural approaches to help with your insomnia, and review these tips for improving your sleep. Sweet dreams!

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