Patients liken hot chemotherapy to “being filleted, disemboweled, and then bathed in hot poison.” Best patient care, or merely the biggest moneymaker?

According to the New York Times, hot chemotherapy, which couples extensive abdominal surgery with blasts of heated chemotherapy to the abdominal cavity and its organs, was once a niche procedure used mainly against rare cancers of the appendix. Most academic medical centers shunned it. Now it’s being offered to patients to treat more common colorectal or ovarian cancers.

Dr. David P. Ryan, clinical director of the Massachusetts General Hospital Cancer Center, says there is little evidence that it really works and “has almost no basis in science.” The treatment is extremely costly, and is something of a desperation move by leading medical centers because the competition for patients and treatments is so intense.

So why is this dangerous, scientifically unsound, and outrageously expensive procedure considered a viable treatment option for cancer patients, when intravenous vitamin C—safe, effective, and far less expensive—is questioned as an adjunct therapy? Why is this common vitamin, administered in high doses intravenously, labeled an unapproved drug by a hostile FDA?

Why also is the nutritional advice for cancer patients from the American Dietetic Association so half-hearted? It seems more focused on stopping weight loss during chemotherapy or radiotherapy than it is about using nutritional and other natural factors to help rebuild immunity and get the body more into balance. Could it be because the organization gets about $1 million a year in payments from pharmaceutical companies?

You know the old saying: just follow the money. As we reported previously, oncologists are the only doctors allowed to sell—and profit from—their own drugs. Oncologists can buy chemo drugs at a deep discount and then dispense them at the higher rate in their offices. It lets oncologists run a kind of pharmacy as a side business, and represents a considerable part of some oncologists’ income. Contrast that with intravenous C. Because it is a vitamin, IV-C is inexpensive, and it cannot be patented, so no one makes any serious money. Oncologists lose the financial incentive to prescribe it.

The overtreatment of minor cancers is a growing problem. This is especially the case for prostate and breast cancer. Not long ago, prostate cancer was commonly detected with a digital rectal examination, which revealed palpable neoplasms. PSA (prostate-specific antigen) testing detected many more cancers—which led to many more biopsies and treatments. However, the observation that the number of cancer deaths stayed the same suggests that a substantial percentage of cases are unlikely to progress. Still, about 90% of diagnosed men seek immediate “curative treatment,” which in theconventional medicine world means chemo and surgery.

There is some good news—the tide may be turning, albeit very slowly. A recent statement from NIH stated that “active surveillance” is a viable option as treatment for low-risk cancers. This is a blow to the current standard of care touted by mainstream medicine.

At the same time, the active surveillance approach also recommends multiple biopsies to monitor the progression of the tumor. This is extremely problematic for several reasons. First, even the NIH admits that infection through biopsy is one of the side effects of active surveillance.

As we reported last year, studies from three countries show that infectious complications from prostate biopsies have more than doubled in less than a decade. As much as five percent of prostate biopsies develop infections from the procedure—or about 50,000 Americans every year, and an equal number in Europe. Nine out of 10,000 men whose tests were negative for prostate cancer died within a month from sepsis and other complications, according to a recent study in the Journal of Urology.

The greater risk, however, is that biopsies can cause cancers to spread, usually along the path of the biopsy needle, a phenomenon called “needle track seeding.” A 2004 study concluded that manipulation of an intact tumor, either by fine needle biopsy or by large-gauge needle core biopsy, is associated with an increase in metastases, perhaps due in part to the mechanical disruption of the tumor by the needle.

Another study suggests needle track seeding as a possible occurrence with breast biopsies, and concludes that the cancer may recur “if the tract is not excised or radiotherapy not given.” So the way to fix the spread of a cancer via biopsy is to do more surgery and/or radiation! This is exactly what happened to a 62-year-old woman whose needle biopsy caused the cancer in her breast to extend the full length of the needle tract. She ended up losing her entire breast because of the biopsy when only an excision was originally needed.

The Nordic Cochrane Centre in Denmark has studied the effects of mammography on breast cancer risk. They found that for every 2,000 women screened, only one will have her life prolonged, while ten will be treated unnecessarily because of “overdiagnosis” and will in the process be more likely to suffer future cancer and other complications. This kind of early, over-detection causes oncologists to administer conventional treatments even though, if the cancer had been left alone, the cancers in most cases would likely have been managed and controlled naturally by the body.

Why does over-diagnosis and over-treatment like this continue? Like chemotherapy treatments, cancer screenings are big moneymakers. This is wrong on so many levels. Hot chemo? Biopsies that spread malignancies? Taking away our right to opt for intravenous vitamin C, basically mandating a one-poison-fits-all, one-size-kills-all approach to cancer? It would seem that if you rely solely on conventional medicine to diagnose and treat cancer, you may go broke from the horrendous expense—but you may also get sicker and die sooner.

Our Action Alert is simple: Ask your senator or representative to make a one-minute floor speech opposing the FDA’s plan to sweep many supplements off the shelf and make the ones that survive much more expensive. Please help!

As you know, the comment period for the NDI Draft Guidance is now closed, and the FDA will be reviewing all the comments they have received. During this period, we want to make the Draft Guidance such a hot-button political issue that FDA will be forced to take notice and will address the public’s serious concerns.

As we reported last month, two powerful senators and longtime friends of natural health, Sen. Tom Harkin (D-IA) and Sen. Orrin Hatch (R-UT), wrote to FDA Commissioner Margaret Hamburg and formally asked the FDA to withdraw its guidance document. We thank these courageous senators for speaking out and clearly articulating the problems inherent in the FDA’s proposal.

In addition, Rep. Randy Hultgren (R-IL) recently made a one-minute speech entitled “Overregulating Dietary Supplements Endangers Americans’ Jobs and Health” on the floor of the House of Representatives. This was his speech:

Madam Speaker, I rise today to express my concern over another example of rampant government regulation.

For seventeen years, the Food and Drug Administration has sought to ignore congressional intent and create a vast new regulatory regime for dietary supplements. Millions of Americans, including many of my constituents and my family, rely on dietary supplements as part of their everyday health maintenance routine. Moreover, they play an important role in ensuring that people take individual responsibility for preventative health care. We all can agree that the FDA should not limit Americans’ access to dietary supplements….

Last week, the comment period on the FDA’s draft guidance closed. Now that they’ve heard from the public, and now that I’m sure they’ve heard from countless Americans who share my concern, I urge them to go back to the drawing board and ensure that they do not limit Americans’ access to dietary supplements.

Simple. Clear. Direct. And painless.

Today we’re asking you to send a message to your senators and your congressional representative. Ask them to make a simple one-minute floor speech in opposition to the guidance. Urge them, just as Senators Harkin and Hatch did, to ask the FDA to retract the guidance altogether and start over. Remind them too of the economic impact—an argument that will have a great deal of power right now—that the NDI draft guidance is bad for the economy and costs American jobs. Please send your message today!

If you are a resident of Illinois, please take action here:

If you are a resident of Iowa, please take action here:

If you are a resident of Utah, please take action here:

If you are a resident of any other state, please take action here:

In another outrageous power-grab, FDA says your own stem cells are drugs—and stem cell therapy is interstate commerce because it affects the bottom line of FDA-approved drugs in other states!

We wish this were a joke, but it’s the US Food and Drug Administration’s latest claim in its battle with a Colorado clinic over its Regenexx-SD™ procedure, a non-surgical treatment for people suffering from moderate to severe joint or bone pain using adult stem cells.

The FDA asserts in a court document that it has the right to regulate the Centeno-Schultz Clinic for two reasons:

1. Stem cells are drugs and therefore fall within their jurisdiction. (The clinic argues that stem cell therapy is the practice of medicine and is therefore not within the FDA’s jurisdiction!)
2. The clinic is engaging in interstate commerce and is therefore subject to FDA regulation because any part of the machine or procedure that originates outside Colorado becomes interstate commerce once it enters the state. Moreover, interstate commerce is substantially affected because individuals traveling to Colorado to have the Regenexx procedure would “depress the market for out-of-state drugs that are approved by FDA.”

We discussed the very ambiguous issue of interstate commerce last September—it’s an argument the FDA frequently uses when the basis for their claim is otherwise lacking. As we noted then, the FDA holds that an “interstate commerce” test must be applied to all steps in a product’s manufacture, packaging, and distribution. This means that if any ingredient or tool used in the procedure in question was purchased out of state, the FDA would in its view have jurisdiction, just as they would if the final product had traveled across state lines.

This time the FDA just nakedly says in court documents that the agency wants to protect the market for FDA-approved drugs. No more beating around the bush—their agenda is right out in the open! This appears to be a novel interpretation of the Food Drug and Cosmetic Act (FD&C), as evidenced by the government’s failure to cite any judicial precedent for their argument.

The implication of the FDA’s interpretation of the law, if upheld by the court, would mean that all food, drugs, devices, and biologic or cosmetic products would be subject to FDA jurisdiction. The FDA is expanding its reach even to commerce within the state, which we argue is far beyond its jurisdiction, in order to protect drug company profits.

Last year we ran a two-part series on the current status of federal and state law—and FDA jurisdiction—and how it affects integrative treatments (part one and part two).

The Centeno-Schultz Clinic takes your blood, puts it into a centrifuge machine that separates the stem cells, and a doctor puts them back in your body where there is damaged tissue. The clinic has argued numerous times that stem cells aren’t drugs because they are components of the patient’s blood from his or her own body.

The FDA says otherwise: “Stem cells, like other medical products that are intended to treat, cure, or prevent disease, generally require FDA approval before they can be marketed. At this time, there are no licensed stem cell treatments.” There they go again, saying that components of your body are drugs and they have the authority to regulate them! It’s the only way the agency can claim that adult stem cell therapy is within FDA’s purview.

However, the agency seems to be of two minds. When ESPN magazine was doing a story on stem cell treatments, the FDA stated that US policy is to allow the injection of stem cells that are treated with “minimal manipulation,” which federal regulations define as “processing that does not alter the relevant biological characteristics of cells or tissues”—which is certainly the case with the Regenexx clinic.

Despite this policy, FDA has been attacking the clinic for the past four years. They have tried injunctions and demanded inspections in their attempts to make the company bend; this court battle is merely the latest salvo.

The primary role of adult stem cells in a living organism is to maintain and repair the tissue in which they are found. The hard part has been to get enough of them. But new technology is giving doctors the ability to obtain more stem cells from a patient than previously thought possible, which is why we’re now seeing new treatments. Blood, fat, or tissue is withdrawn from the patient, stem cells are obtained using one of these new processes, and the cells are injected back into the patient where they can repair the patient’s tissue.

Gov. Rick Perry received this kind of stem cell therapy. We and others noted that the governor’s defense of freedom of healthcare choice when it came to his own treatment was starkly at odds with his directive to administer HPV vaccines to young girls against their own (and their parents’) wishes. It’s also at odds with his support for some of the most egregious witch-hunters on the Texas State Medical Board, which he appoints.

Behind Perry’s blatant inconsistency and the latest FDA attempted power grab lies the same problem: a medical system run by special interests under the leadership of the US government, the same government that is supposed to represent “we the people.”

Congress wants to limit your access to research—even though your tax dollars paid for it. If this bill passes, you’ll learn only what mainstream medicine wishes you to know. Action Alert!

In 2008, the National Institutes of Health required that all federally funded research publications be made openly available. PubMedCentral (PMC) is a free full-text archive of biomedical and life sciences journal literature at the National Institutes of Health’s National Library of Medicine.

The publishers of the journals weren’t so happy with this new arrangement—they were afraid no one would pay for their publications if the research results were immediately accessible. So the government agreed to give them a full year of journal sales before their research papers had to be posted on PMC, which lets them keep their subscriber base. Journal subscriptions to educational and medical institutions are expensive—and they’re big business.

But even this generous arrangement isn’t good enough for the Association of American Publishers (AAP). The trade group liked the old rules, where they could sell the tax-funded research back to the taxpayers. So the AAP got two members of Congress, Rep. Carolyn Maloney (D-NY) and Rep. Darrell Issa (R-CA), to introduce HR 3699, the Research Works Act, just before the end of 2011.

This bill would prevent the NIH or any other agency from causing or even allowing private-sector research work to be disseminated online without prior consent of both the publisher and the study authors—even if the funding came from our tax dollars.

The AAP weren’t the only publishers involved. Elsevier—the Reed Elsevier Publishing Group, a multinational company that publishes around 2,000 journals and close to 20,000 books and major reference works—happens to be in Rep. Carolyn Maloney’s district, and Elsevier employees made campaign contributions to both Issa and Maloney. (Apparently, it only takes $10,500 to buy two members of Congress.)

Said contributors all work for Tom Reller, vice president for global corporate relations at Elsevier. Interestingly, an email about the bill from Rep. Maloney to one of her critics contained language that was nearly identical to language used by Reller when he was defending the same bill! Are members of Congress employing lobbyists as ghostwriters now?

This is about access to peer-reviewed scientific information—research that we pay for with our tax money. If this bill passes, Americans who want to read the results of federally funded research will have to buy access to each journal article individually—at a cost of $15 or $30 apiece. In other words, as the New York Times recently noted, taxpayers who already paid for the research would have to pay again to read the results.

Access to peer-reviewed scientific research is essential if you are to make informed choices regarding your family’s health—especially if you choose complementary and alternative medicine. Good research will let us choose wisely when it comes to questions of treatment modalities, vaccines, diet, nutrition, and medicine. Right now, supplement companies aren’t even allowed to tell you about the science behind their products, so we must get the scientific information directly from the source.

But that’s just the problem: consumers, integrative doctors, and small businesses might not have the funds to access all these scientific journals—which means your access to the science behind natural products will be limited to what mainstream medicine may wish you to know.

PMC compiles entire studies and has 2.3 million articles going back to 1965. It allows patients, physicians, students, teachers, and advocacy organization like ANH-USA to read about and cite the discoveries that our tax dollars paid for—to keep you informed in these pages, we may review as many as a hundred studies every year. If we needed to pay a publishing company every time we viewed a study which taxpayers have already paid for, we’d be giving thousands of dollars to a publishing company every year instead of protecting your access to natural health.

So what can you do? Two things will make a huge difference!

• First, help us gain co-sponsors for the Free Speech about Science Act (FSAS). This landmark legislation enables the natural health products community to share peer-reviewed scientific findings about natural health products with the public. The problem, of course, is that if it becomes more difficult for supplement companies and consumers to access the scientific studies themselves, the entire point of FSAS is effectively undermined.
• The second step is to ask Congress to defeat this new Research Works Act. Please send your message today and explain why limiting access to the results of important studies—which your tax dollars have already paid for—is such a terrible idea. Take action immediately!

The USDA’s food safety wing may come under control of the FDA. This will mean more power, wider scope—and greater corruption.

Allegedly as a means of eliminating agency overlap and bureaucratic waste, the Obama administration wants to consolidate a number of federal agencies. Last year the president pointed out that the Interior Department is in charge of salmon while they’re in fresh water, but the Commerce Department handles them when they’re in saltwater, and joked, “I hear it gets even more complicated once they’re smoked.”

According to an official at the Office of Management and Budget, the USDA’s Food Safety and Inspection Service (FSIS) would be merged with the food safety unit at the FDA. While the proposal sounds reasonable on the surface, this would do nothing to address the systemic conflicts of interest within the FDA, and would actually increase the agency’s tendency toward crony capitalism.

Food Safety News reports that Mike Taylor, the former acting undersecretary for food safety at the USDA and the current deputy commissioner for foods at the FDA, has been advocating for a single food safety agency located “anywhere but at the USDA.” Former USDA official Dr. Richard Raymond, who now works as a food safety and public health consultant, believes that “a merger of the two food safety agencies would be an unmitigated disaster,” and unless megadollars flowed with the merger, nothing more could be accomplished than is currently done.

We might add that much harm could be done because the FDA knows nothing whatever about farming. The Food Safety Enhancement Act has already put FDA on the farm as a potential rule-maker and inspector, ignoring the agency’s complete lack of expertise in this field.

Obama administration officials are said to favor the merger because it would make food safety independent of USDA which, they note, primarily exists to market and promote American farm products. But rather than addressing the real issue—that USDA is in the pocket of the agricultural industry (“Big Farma”)—the administration instead wants to shift food safety over to the FDA, where both Big Farma and Big Pharma rule the roost.

Worse than that, the FDA will undoubtedly employ the form of food safety analysis it has learned about from its international counterparts over many years of meetings on food safety at Codex Alimentarius. This kind of food safety tends to say that food additives like aspartame, as well as a whole host of pesticides residues and genetically-modified (GM) foods, are safe, while demonstrating inexcusable scientific ignorance with their dietary advice.

If you think crony capitalism is bad at the USDA, just look at FDA’s existing record in regulating agriculture products. Two weeks ago we reported on how FDA crumbled under agriculture industry pressure and announced that the agency would no longer try to restrict the routine use of antibiotics in animal feed.

Then there’s FDA’s attempts to win approval for AquaBounty’s genetically engineered salmon despite overwhelming consumer opposition. Jurisdiction over genetically engineered food is shared by both the USDA (agriculture) and the FDA (food products). Both agencies are heavily influenced by the powerful GMO industry. Consolidation would merely ensure faster passage for genetically engineered products. So much for a new emphasis on “food safety”!

FDA is seriously underfunded and notoriously inept—their management of pharmaceuticals has led to skyrocketing prices, drug shortages, and a shocking lack of transparency—even suppressing scientific data about medicines that the drug companies found unfavorable. There is no indication that the FDA becoming a megabureacracy with complete control over food safety would produce better results.

Help us reform the FDA! An agency whose approval of dangerous drugs kills 50,000 Americans each year, and which systematically attacks natural supplements and censors scientific research, should not be getting more power and authority over our food supply. Please read about our Reform FDA campaign, and then sign our petition, which we will hand-deliver to Congress!

Statins are taken by one in four Americans over the age of 45, even though diet can fix high cholesterol quicker and more safely. Here’s new evidence of the drugs’ dangers.

A University of Massachusetts Medical School study has found that statins significantly increase risk of type 2 diabetes among postmenopausal women—an increased rate of 48% compared to those not on cholesterol-lowering drugs. The data comes from the massive Women’s Health Initiative, which surveyed 161,808 women.

Interestingly, this is not the first study to reveal such a link. A 2011 study found that the risk of adult-onset diabetes is much higher in patients who take high doses of statin drugs. And a 2010 meta-analysis found that statin therapy of any dosage was associated with 9% greater risk of diabetes.

But in the face of this research, the media is bending over backwards to say that the risk of statins do not outweigh the “benefits”! The headline of the Associated Press article (which was picked up by countless media outlets) says that statins are linked to “small diabetes risk,” calling them “cholesterol-lowering wonder drugs.”

The article continues, “Specialists say people who most need statins because of a high risk for a heart attack should stick with the drugs,” and quotes a doctor not involved with the research as saying, “What I fear here is that people who need and will benefit from statins will be scared off of using the drugs because of reports like this.” The AP also notes that more and more doctors are urging otherwise healthy people to use the pills as a way to prevent heart disease.

Conspicuously absent is any reference to recent findings from mainstream medical authorities that statins show no benefit whatsoever in reducing cardiovascular disease risk among patients who are currently at low risk of heart attack.

WebMD’s analysis of the study quickly states, “Experts say the evidence as a whole suggests that the risks are slight and that for most women who take statins, the benefits for preventing heart attack and stroke outweigh those risks.”

Let’s look at some of those “benefits.” As we reported recently, statin drugs:

• Weaken the immune system and make it difficult to fight off bacterial infections, and increase the production of cytokines, which trigger and sustain inflammation.
• Make some patients unable to concentrate or remember words, and is linked to muscle and neurological problems, including Lou Gehrig’s Disease.
• Have documented side effects which include nerve damage, muscle damage, liver enzyme derangement, and in some cases even kidney failure, not to mention, tendon problems, anemia, acidosis, cataracts, and sexual dysfunction.

This is all in addition to the blood glucose elevation and increased risk of diabetes.

Even more outrageously, some years ago the British Medical Journal advocated widespread use of a polypill that combines six different drugs—a statin, three low-dose antihypertensives (thiazide, an ACE inhibitor, and a beta-blocker), folic acid, and aspirin. In an editorial last year, MedPage Today, a service for physicians that gives medical news from a clinical perspective, suggested putting this combination directly into the water supply—though, it said, “we could probably drop the folic acid.”

(Dropping folic acid is not a bad choice, actually: it’s a synthetic, oxidized form of the B vitamin which can build up in the bloodstream and may become carcinogenic if you have too much. If you want plenty of natural folate, eat lots of dark green vegetables or get the reduced form, 5-methyl tetrahydrofolate [5-MHTF] in high-quality supplements!)

Now let’s contrast mainstream media’s support of statins and other dangerous drugs with their negative coverage of natural approaches to good health, including supplements. Look how many recent articles have made outrageous and demonstrably false statements like antioxidants not necessarily being good for one’s health, or vitamin use leading to an earlier death. The ultimate irony is that any time safety issues with very high-dose supplements have cropped up, as shown with beta-carotene and later with vitamin E, they’ve always been linked with the isolated, pharmaceutical forms of these vitamins, not the natural forms.

Remember the media coverage around the vitamin D study last November? The media said that people who take too much vitamin D were 2½ times more likely to develop atrial fibrillation—which, as we reported, the actual study absolutely did not say—thus scaring people away from an essential supplement. This is especially tragic since at least one-third of all Americans are actually deficient in vitamin D.

Do we really need any further evidence that conventional medicine, multinational pharmaceutical manufacturers, and the advertising industry are working hand-in-hand to further their own interests—and are using a compliant media (who are utterly dependent on advertisers) to carry out their agenda?

Help us persuade Congress to reform the agency with our Action Alert!

Drug research, even from clinical trials sponsored by the federal government, is routinely suppressed, according to a new study in the British Medical Journal (BMJ), an international peer-reviewed medical publication. The study found that less than half of all NIH-funded clinical drug trials were published in a medical journal within two and a half years of the trial’s completion—with fully one-third of trial results remaining unpublished even four years after the trial. Why? Because the drug manufacturers didn’t like the data.

One example cited in the study was the FDA-approved diabetes drug Avandia, which in 2007 was found to increase heart attacks and cardiovascular deaths—even though the drug’s maker, GlaxoSmithKline, had known about the risk before the drug was approved. The BMJ study found that 35 of the drug’s 42 clinical studies had never been published, and were obtained only because a court case required the pharmaceutical company to turn over the data.

Not only does this irresponsible practice harm patients, it also increases healthcare costs. Eugene Carragee, a Stanford University orthopedic surgeon and editor-in-chief of the Spine Journal, spearheaded an unprecedented independent analysis showing that the medical device manufacturer Medtronic—not to mention a circle of orthopedic surgeons who received millions of dollars in royalties from the company—systematically failed to report serious complications with Medtronic’s bone-growth stimulating back surgery device known as Infuse. The results of a crucial clinical trial of the product were not published until nearly five years after the trial had to be halted because unwanted bone was growing around the spines of the trial volunteers.

For two years, Schering-Plough, the maker of the popular cholesterol drug Vytorin, sat on the results of a clinical trial showing that the drug provided no benefit in improving artery health. During that time, the drug was heavily marketed to consumers in TV ads; the marketing was only halted in 2008 after a congressional investigation was launched.

In 2003, a clinical trial of Multaq, a drug that treated cardiac arrhythmias, 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 atrial fibrillation in certain patients—just not as a means to reduce deaths!

Why does FDA approve drugs whose data have been suppressed by the manufacturer? Is it because FDA depends on Big Pharma for its budget—and needs drug companies to hire former FDA employees. The Wall Street Journal reported that FDA advisers, in a recent vote, said the benefits of four popular Bayer AG birth control pills outweigh the blood clot risk. What the FDA didn’t disclose is that three of the advisers have had ties to Bayer, serving as consultants, speakers, or researchers!

Despite the FDA’s bias in favor of drugs and against supplements, there are tremendous shortages of some drugs (though no shortage of supplements—so far!). This drug shortage prompts some hospitals to engage in price gouging, so a drug that usually costs $26 is being offered for $1,200. Moreover, the FDA artificially inflates drug prices—especially generic drug prices, which should be far lower than they are—as we have reported previously.

The shortage in the US drug market also makes foreign counterfeit drugs more popular. Recently, some 65 million counterfeit pills were seized in China; no word yet on how many of them had already made their way to the US.

If this is the way FDA oversees dangerous drugs, what will happen if we give them the same authority over supplements? It’s not just that the agency doesn’t have the knowledge to properly oversee supplements—they also don’t have the capacity. If they can’t keep up with the hundreds of drugs already under their purview, how will they cope with the thousands of supplements on the market? One way, of course, is for them to drastically reduce the number of supplements that can be marketed—one inevitable result of the NDI draft guidelines that we have been campaigning against.

There must be sincere and honest people working for the US Food and Drug Administration, but it is currently being run in a corrupt and incompetent way. It desperately needs to be reformed. Please help us in our ongoing campaign to overhaul the agency by signing our petition to Congress. As we say in the petition, “Everything about the FDA must be taken apart, reviewed, redefined, and re-created so that it supports, not obstructs, the mission of advancing medical science and vibrant good health for all.” Please take action today!

A former ANH-USA board member joined with Michelle Obama to announce an exciting new program to help veterans with traumatic brain injuries. A new Action Alert!

Health pioneer Dr. Paul G. Harch, associate clinical professor of medicine at Louisiana State University in New Orleans, will participate in the White House’s Joining Forces Initiative. The program will teach medical schools better ways to train new doctors to care for veterans’ needs, including hyperbaric oxygen therapy treatment (HBOT), the premier therapy for brain injuries and PTSD.

You may recall our article last month about Dr. Harch’s study which was published in the Journal of Neurotrauma—well, apparently someone listened after all. The White House is recognizing the importance of cutting-edge research like that being done in New Orleans. In her announcement, the First Lady discussed “the mental health challenges many of our troops face once they return home.” Dr. Harch joined Michelle Obama in making the announcement.

TBI and PTSD severely and disproportionally affect military who have served in Iraq and Afghanistan—approximately 546,000 have TBI, post-concussion syndrome (PCS), and PTSD, and yet their treatment options are limited. HBOT is an effective and economical treatment for PCS and PTSD, without the very dangerous and negative side effects of antipsychotic medication.

By participating in the initiative, LSU’s Health Services Center has promised to mobilize research and clinical care (including HBOT) to treat vets and their families. One important note, however: according to Dr. Harch, the Joining Forces Initiative has not officially committed to actually funding any of these research projects, only to sharing ideas and programs. He hopes the administration, having announced this initiative, will help fund the initiative since the medical schools and state budgets are cash-strapped.

In other good news, Dr. Harch has been awarded a $1.2 million government appropriation to further investigate HBOT for TBI and PTSD. This funding is greatly needed, since HBOT is currently FDA-approved for many uses, but not approved as a treatment for TBI or PTSD. This in turn blocks both use and payment.

With the White House spearheading this initiative, it could mean that the tide is turning, and FDA’s non-approval of HBOT for TBI or PTSD may be crumbling. Ditto DoD’s absurd refusal to use HBOT because it’s “off-label,” when the department already uses antipsychotic drugs completely off-label for treatment of TBI and PTSD. The president is the commander-in-chief of the armed forces, so if he listens to his wife (not to mention scientific leaders and citizens like you) and orders it, the DoD will fall into line.

Please write to President Obama today, thank him for the First Lady’s initiative, and ask him to take a strong leadership role in making HBOT the primary therapy for TBI and PTSD. You might mention that he is supporting the troops in a way that will save untold numbers of them from lives of misery after serving their country, and ask him to make sure the Joining Forces Initiative is provided funding so HBOT can actually be administered to our veterans. Please take action today!

There are many questions about how the healthcare act will actually work, but complex regs just released seem likely to doom the very programs that help us pay for our integrative medical treatments. New Action Alert!

An important provision of President Obama’s Patient Protection and Affordable Care Act (PPACA) requires insurance companies to use at least 80% of premium dollars (85% for large employer plans) on healthcare expenses and quality improvement, rather than on sales, overhead, and profits. If they don’t, the insurance companies will be required to provide a rebate to their customers starting in 2012.

This requirement is called the Medical Loss Ratio, or MLR. The government estimates that up to 9 million Americans could be eligible for rebates starting in 2012, worth up to $1.4 billion—which is intended to put pressure on the insurance companies to keep their administrative and sales costs as low as possible.

The Department of Health and Human Services (HHS) recently issued its final standards on how to rebate money from insurance carriers that fail to reach the MLR standards. In essence, the new rules of how MLR is computed discriminate against health plans with higher deductibles. Particularly hard hit will be the Health Savings Accounts (HSAs) that help so many of us pay for complementary and alternative medical (CAM) treatments not covered by regular insurance.

A bit of background: The advantage of HSAs for those of us relying on integrative medicine is that we control how the HSA money is used. We don’t need insurance company approval. So we can use that money to pay an integrative doctor whose services would not be reimbursable under a conventional insurance policy. We can then add to the HSA a high-deductible (low-cost) conventional medical policy to cover us in case we need those services—for example, if we are injured in an auto accident.

If high-deductible plans are eliminated, then our only option is to combine an HSA with a much more expensive conventional policy. That will make integrative care completely unaffordable for many. It will also lead to less demand for HSAs. Before long, they would probably disappear. If HSAs disappear, direct consumer control over healthcare would suffer yet another blow. As many analysts have suggested, the fact that consumers do not directly buy medical services explains much of what is wrong with medicine today.

With this background, let’s now return to the new regulations and see why they are a threat to high deductible medical policies and thus to HSAs. The problem is that under the new regulation, any payment for a healthcare service that an individual or family makes, either directly or through an HSA—that is, any payment that’s part of the deductible—doesn’t count toward the requirement that your medical insurer must spend 80 to 85% of all insurance premiums on medical treatments. Only payments for healthcare services that are made by insurers count, not payments by individuals or through HSAs. As with many government regulations, the implications of this may not be readily apparent. Here’s a helpful illustration:

• Let’s say I pay $5,000 for in premium insurance policy which has no deductible. I have $4,000 in medical expenses, which the health plan pays. Because the insurer’s payment comes to 80% of my premium, my health plan is in compliance.
• However, let’s say I pay $4,000 in premium for a policy with a $1,000 deductible, and I still have $4,000 in medical expenses. I pay the first $1,000 directly to meet my deductible, and the health plan pays the remaining $3,000. That’s only 75% of my $4,000 premium, so the plan is not in compliance with the new MLR regulations, and the insurance company would have to give me a rebate, even though I spent $5,000 out of pocket and received $4,000 in medical care in both scenarios.

Sounds like a win-win situation, right? Except that under these circumstances, insurance companies will simply drop plans that have high deductibles.

Only five percent of consumers who have an HSA health plan will have any claims paid by their insurance in the course of a year. Therefore, it is a mathematical impossibility for HSAs to meet the MLR limits when the new HHS rule allows only five percent of HSA payments for health care services to count towards their MLR limit.

This means that HSAs will disappear from the insurance marketplace (the state Health Insurance Exchanges) because they rely on higher deductible policies.

HSAs, FSAs (Flexible Spending Arrangements), and lower-cost plans were specifically mentioned in the PPACA bill—Congress therefore appeared to want them to be available to the public. To further complicate the picture, the Act itself also endangered HSAs, as we have pointed out in earlier articles, by saying that deductibles in all plans would be limited.

The statute says that deductibles cannot exceed $5,000 for an individual under age 30 or $10,000 for a family with parents under 30, and cannot exceed $2,000 for an individual over 30 or $4,000 for a family with parents over 30. However, the statute also says that medical insurance must cover at least 65% of our medical expenses, so even these reduced allowable deductible levels may be reduced further when the 65% requirement is better defined. These provisions of the Act already threatened the existence of HSAs.

The new HHS regulations come along and twist the knife in further by interpreting the Medical Loss Ratio requirement in a way that is completely inconsistent with the continued existence of HSAs. Whether the destruction of HSAs was intended or not, we would argue that these new rules are absolutely contrary to congressional intent.

The good news is that since HSAs are specifically mentioned in the PPACA legislation, they can’t legally be killed by agency regulations, over and above the injury already received from the statute. Please contact your senators and representatives immediately and ask them to intervene to change these new regulations and help save Health Savings Accounts. Please take action today!

Just as everyone was making last-minute holiday preparations, the FDA quietly announced they would no longer try to restrict the routine use of antibiotics in animal feed. An Action Alert update!

The so-called “preventive” use of antibiotics in livestock is routine and widespread. Factory farms use them to ward off illness in animals that are kept in overcrowded, filthy living conditions that are a perfect environment for the spread of illness. These antibiotics also promote increased growth in animals.

In fact, 80% of all antibiotics sold in US go into farm animal feed. Germs resistant to one or more drugs kill 100,000 hospital patients every year in the US, which costs the healthcare system more than $34 billion.

In the last eighteen months, the World Health Organization issued a global alert on the dangers of antibiotic-resistant superbugs; antibiotic-resistant bacteria sickened people in three states; and a study found that up to half of US meat was contaminated with antibiotic-resistant staph. The agriculture industry stridently opposes legislative and regulatory attempts to curtail antibiotic usage, making the absurd claim that the science is still inconclusive.

For the past thirty-five years, the FDA has supposedly been trying to curtail the routine use of antibiotics. Odd that such a long-lived and concerted effort by such a powerful agency has failed so miserably, isn’t it? In 2008, the FDA issued an outright ban of the cephalosporin for livestock. But the agency withdrew the plan after strong opposition from industry groups that wanted to preserve some uses of the antibiotic.

On December 22 (probably hoping no one would notice in the holiday craziness), the FDA quietly withdrew its three-decade-old request to remove antibiotics from animal feed. “FDA believes that by implementing [a voluntary compliance] strategy, it will achieve its goal of promoting the judicious use of antimicrobial drugs in a more timely and resource-efficient manner than could be accomplished otherwise,” the agency said in its announcement. “FDA’s experience with contested, formal withdrawal proceedings is that the process can consume extensive periods of time and significant amounts of Agency resources” [emphasis ours].

In plain English, FDA is saying that industry opposition makes pursuing a ban too expensive. Big Ag is opposing something that probably every single American, if you stopped them on the street and asked them, would be in favor of—and the FDA is listening to industry rather than the hundreds of millions of Americans who want food that isn’t laden with hazardous antibiotics.

Happily, people did notice that FDA had bowed down to Big Farma, and immediately made a ruckus. So last week, to appease public outrage, FDA imposed new (but extremely slight) limitations on antibiotics that will barely make a dent in the real problem.

The new rule limits some uses of cephalosporin in some animals, banning routine injections into chicken eggs, and large or lengthy dosing in cattle and swine. This rule is much less strict than the ban proposed in 2008, since it still allows veterinarians to use “off-label” antibiotics, and it doesn’t address small-scale-production animals like ducks and rabbits. Nor does it cover the use of penicillin and tetracycline in feed and water when used for promoting the growth of animals or preventing illness that results from unsanitary living conditions—a practice that accounts for the majority of antibiotic use in agriculture. Why are they used so widely? Because unlike cephalosporin, these antibiotics do not require a veterinary prescription.

When asked about the lack of a guideline for the use of penicillin, FDA Deputy Commissioner Michael R. Taylor—who just happens to be a former Monsanto executive!—said, “We’re hopeful that in the coming months, we’ll be able to carry forward on that work.” In other words, “That’s not on our current agenda.”

The FDA drastically (and perhaps purposefully) underestimated the number of NDI submissions that will be required under their proposed draft guidance for dietary supplements. If they don’t have the manpower, funding, or scientific clout to do something as simple as standing up to industry pressure on antibiotics in animal feed, how are they going to evaluate thousands of NDI submissions? Talk about skewed priorities! They can’t (or won’t) stop this dangerous practice, but they’re happy to waste their limited resources—and our tax dollars—attacking supplements

We say it all the time, but it bears continued repeating: Supplements aren’t killing people. Drug-resistant bacteria are.

HR 965, the Preservation of Antibiotics for Medical Treatment Act, now has 74 co-sponsors, but the bill has been stalled in the Health subcommittee since March of last year. Please write to your representative and senators today about FDA’s inability or unwillingness to take substantive action, and ask them to take action on this important bill right away! Please take action today!

No, this doesn’t involve diet or supplements or exercise.

One of the most altruistic and easiest things to do is to give blood. But you may not realize just how much it can improve your heart health.

“Blood viscosity” is one of the most important, but least understood, factors in cardiovascular health. Cardiovascular disease is the leading cause of death and a factor in one-third of all deaths. And how thick and sticky your blood is—how much friction your blood creates moving through the blood vessels— is a major factor in determining how much abrasion and damage it does to the lining cells (endothelium) of your arteries.

According to Dr. Ralph Holsworth, DO, the top expert in blood viscosity in the US, when your endothelium is damaged, your body “patches” the tissue with lipids (fats) which begin to thicken and harden, forming a “plaque.” And that creates a vicious cycle: abrasion from your blood flow prompts the body to thicken artery walls, which reduces the size of blood vessels, which creates more friction with the blood flow, which makes more “patches” form, until the artery wall becomes so thick that blood can no longer flow through. And that produces a heart attack. A study in Scotland found that a group of patients with extensive heart disease had much higher blood viscosity levels than the healthy control group.

As our friend Jonathan V. Wright, MD, put it in a recent newsletter article, “Think for just a moment: If your blood is thick and sticky, is it going to flow along as easily in your arteries and veins as blood that is thinner and less sticky? Does tomato paste flow as easily as tomato juice? Of course not.” Blood that’s too thick also hinders your body’s ability to deliver nutrients like oxygen, which are carried to your cells and tissues by your blood, to the “farthest reaches” of your circulatory system. That’s why the legs, which are the furthest from your heart, often display circulatory problems first.

The good news is that your risk of heart attack can be reduced by reducing your blood viscosity—and the best way to do this is to give some blood regularly. Men are much more susceptible to circulatory viscosity problems than menstruating women are: the blood lost from menstruation seems to have a protective effect. However, after menopause women’s risk begins to approach that of men, and women with irregular or absent periods are 28% more likely to develop heart disease than women with regular periods.

In the past, men have been told that donating blood will reduce the level of iron in their blood and that this was heart protective. This is true, but it now appears that reducing one’s iron levels, while important, is not nearly as important as controlling blood viscosity.

It also appears that the most efficient way to control your blood viscosity is simply to donate some of it! A study of nearly 3,000 middle-aged men found that men who donated blood had 88% less risk of acute myocardial infarction (heart attack) compared to men who didn’t donate.

In light of this research, Dr. Wright suggested that ANH-USA launch a new campaign to encourage not only our readers but everyone to donate blood regularly. This is a great idea. Let’s all do it. We’ll live longer, and we may save someone else’s life!

Blood donations are urgently needed. According to America’s Blood Centers, community blood centers have lost thousands of loyal potential donors due to new deferrals put in place by the FDA—some of which have been criticized as unnecessary and based on questionable science.

But some people cannot donate blood for quite legitimate reasons. What if you fall into that category? Not to worry! You might be able to find an integrative doctor who will draw your blood, which will not be used for donation. Alternatively you can still reduce your risk of heart attack and lower your blood viscosity by taking high-quality fish oil. As Dr. Wright emphasizes, fish oil should be paired with vitamin E as “mixed tocopherols” to prevent damage from oxidized lipids. Regular vitamin E is alpha-tocopherol alone, so be sure it is mixed tocopherols.

Of course, as in most areas of life, there can be too much of a good thing. Too-thin blood can also be a problem, so blood viscosity should be measured before increasing fish oil intake. Have your blood viscosity tested by your doctor to determine how frequently you should donate blood or how much fish oil you should take to reduce your personal risk of heart attack and optimize your blood flow. Dr. Wright’s Meridian Valley Laboratories offers Whole Blood Viscosity tests (you can reach them toll-free at 855-405-8378).

Donate blood!
Help yourself, and help another!

And the future looks bright thanks to all your support.

In the early 1990s, a small group of practitioners, MDs, and DOs who used nutritional and other complementary therapies in their practices met to share their concerns. Medical freedom was being threatened by the FDA, by powerful allopathic medical organizations like the AMA, by insurance companies, and by state medical boards around the country. Good doctors were losing their licenses or being driven into bankruptcy simply because they used an unconventional, holistic approach to preventing disease and optimizing health.

Advancements in medicine were being stymied because good practitioners were afraid of censure. Americans had no access to some of the most cutting-edge medical therapies and technologies available in other countries, while medical costs were spiraling out of control, spurred on by the explosion in pharmaceutical, surgical, and chemotherapy treatments, many of them based on doubtful science and not even effective, despite their high cost.

In 1992, this small group began advocating for holistic health practitioners and consumers on Capitol Hill, in state legislatures, in the courts, and with the media. We called ourselves the American Preventive Medical Association (APMA) to reflect our belief that truly preventive medicine focuses on maintaining optimal health with healthy food, key nutraceuticals and dietary supplements, exercise, and complementary medical therapies.

It was a critical time: a coalition of health and industry organizations were mobilizing the largest national grassroots effort ever seen in our country. Working with a broad coalition of allies, we were able to persuade Congress to pass the Dietary Supplement Health Education Act (DSHEA) of 1994—a major reform of the food and drug laws regulating supplements. It specifically prohibited the FDA from classifying supplements as new drugs or food additives, and permitted, for the first time, limited health claims on supplement labels, so long as no specific disease was mentioned. It also stated that the federal government should not take any actions to impose unreasonable regulatory barriers to limit or slow the flow of safe products and accurate information to consumers.

By 2004, the tide seemed to be turning against us with the FDA’s growing power and increased hostility to any approach to health that didn’t bow down before allopathic medicine and FDA-approved drugs. At that time, we changed our name to the American Association for Health Freedom, and channeled our energies into pushing back and saying No to the powers that threatened natural health. We organized a grassroots “Reform the FDA” campaign, and lobbied for the passage of an Access to Medical Treatment Act that would have guaranteed all citizens the right to the medical treatments they desired, as provided by a qualified medical professional.

About the same time, we met the folks at the Alliance for Natural Health, a UK-based organization that seemed to agree with us on just about everything. Their work in Europe since 2002 paralleled the work we were doing in the United States, and we benefited from sharing information and ideas with each other. In December of 2009, the two organizations decided to take our relationship to the next level by becoming the Alliance for Natural Health Europe and the Alliance for Natural Health USA, within one parent organization, the Alliance for Natural Health International.

This year marks our twentieth anniversary, and you have a great deal to be proud of—for we couldn’t have done the smallest bit of it without your support and grassroots activism. Thanks to you, ANH is changing the way medicine is done, and on an even deeper level, even helping to shift consciousness toward a better understanding of how our connection to nature is intimately connected to our health. Most critically, in our country ANH-USA has played an important role in passing significant legislation that directly benefits the natural health approach while blocking legislation that threatens it. We have also filed lawsuits to accomplish the same aims.

• To date, we have filed nine precedent-setting lawsuits against the FDA, which have established qualified health claims for saw palmetto, Omega 3 fatty acids, fiber, vitamin E, vitamin B, and selenium. Our first suit was the landmark case of Pearson v. Shalala—and because we won, there is now widespread public knowledge about the importance of consuming enough folate during pregnancy to prevent neural tube defects. Prior to this legal victory, supplement manufacturers were not permitted to let consumers know about this important nutrient relationship, and many consumers were in the dark.
• We also sued the FDA (and won!) for violating the First Amendment as well as the Administrative Procedure Act by not allowing the dissemination of truthful, scientific information on dietary supplement labels.
• We also succeeded in having the Health Insurance Accountability and Portability Act (HIPAA) state explicitly that the practice of alternative medicine is not fraud—a critical protection for alternative health care practitioners.
• We led the effort to establish the National Center for Complementary and Alternative Medicine (NCCAM) in 1998. It’s part of the National Institutes of Health (NIH), undertakes research, does training, and disseminates data to the public and professionals. NCCAM still isn’t where we want it to be, but we hope to get it there.
• We worked with Reps. Chaffetz and Polis to introduce the Free Speech about Science Act in the House of Representatives, which will permit supplement companies to cite peer-reviewed scientific research in support of product health benefits.
• We organized an emergency response to a major threat to dietary supplements in Congress: Sen. McCain’s Dietary Supplement Safety Act. ANH-USA activists sent more than 200,000 messages to Congress opposing the bill, and we took out a full-page ad in Roll Call, the Capitol Hill newspaper, which highlighted misleading remarks from Sen. McCain on the Senate floor. In just three weeks, Sen. McCain took the almost unheard-of step of withdrawing support for his own bill, which subsequently died without a vote.
• Our activists, still mobilized and eager to act, were then able to defeat a sneak amendment to the Wall Street Finance Reform bill from Congressman Waxman that would have greatly expanded the FTC’s power to target supplement companies.
• Not much later, you sent more than 60,000 messages to Congress opposing Sen. Leahy’s Food Safety Accountability Act, which would have established ten-year prison terms for violating FDA regulations, leading Leahy’s office to reach out to ANH-USA to develop compromise language requiring proof of actual harm for prosecution. When the bill failed to become law, we worked together to ensure the ten-year prison term language did not make it into the Senate’s Food Safety Modernization Act.
• It was not long before the FDA and Sen. Durbin made their coordinated attacks on dietary supplements. The response to our call for activists to oppose the FDA’s new draft guidance has been nothing short of inspiring (read our exciting news on that subject in this issue!).

We’ve filed petitions to ban the use of the toxic chemical BPA in cash register receipts and children’s dental devices. You’ve petitioned the USDA and FDA with us to oppose GMOs, and supported state bills to demand GMO labeling. These petitions are a necessary prelude to lawsuits. We’ve organized a coalition of dietitians and nutritionists to oppose the American Dietetic Association’s ties to junk food companies and anti-competitive legislation, and launched the ReallyEatRight.org website to bring the ADA’s activities to light.

And through it all, we’ve continued to bring you The Pulse of Natural Health every week, keeping you up to date on the politics of natural health and much else besides. You’ve rewarded us with your activism in our campaigns, your insightful comments on our articles, and your generous donations to make all these victories possible.

The freedoms we enjoy today are the direct result of the actions of activists like you. As we mark this milestone in 2012, we will continue to work tirelessly to protect and promote natural health and freedom of choice in healthcare. The last twenty years have shown what we can do when we work together. During the next twenty years, as the crisis in conventional healthcare finally becomes evident to everyone, we have a unique opportunity to bring the word about sustainable and effective natural health options to millions of people around the world as well as our leaders in Washington and state capitals.

Studies say that even moderate to vigorous exercise doesn’t counteract the damage.

A study published in the American Heart Association’s journal Circulation showed that each extra hour of television watching (the ultimate sitting sedentary activity) per day was associated with an 18% increase in deaths from heart disease and an 11% increase in overall mortality. People who watched TV for at least four hours a day were 80% more likely to die of cardiovascular disease than those who watched two hours or less, and 46% more likely to die of any cause.

We have smart readers, and many of you will immediately ask: “Weren’t there other factors, not just sitting, that resulted in this outcome?” Yet that doesn’t seem to be the case. There are specific reasons why sitting, in itself, appears to be dangerous. The message seems to be to move around. But if you aren’t moving around, stand or lie down, which humans have done throughout their history. Avoid sitting in a chair, an activity that is relatively new for human beings and not at all good for us.

Surprising as it is, the increase in heart and mortality risk observed in the Circulation study affected people who met exercise guidelines—and were independent of eating habits as well! Studies reported significant associations between total sedentary time with blood glucose, blood lipids, and adiposity, even in people who performed moderate to vigorous exercise several times each week.

Animal studies also show that how much time we are sedentary is related to how well our bodies process fats. The studies in rats show that leg muscles only produce the lipase lipoprotein (fat-processing) molecule when they are being actively flexed—that is, when standing or, better still, walking around—and low levels of the molecule are associated with health problems, including heart disease. In short, sitting makes this important molecule slow down. In fact, actively contracting the muscles produces a whole suite of substances that have a beneficial effect on how the body uses and stores sugars and fats.

“Many people, on a daily basis, simply shift from one chair to another—from the seat in the car to the chair in the office to the chair in front of the television,” said to the lead author of the study. “Even if someone has a healthy body weight, sitting for long periods still has an unhealthy influence on blood sugar and blood fats.”

It should be noted that sitting too much is not the same as exercising too little. They do completely different things to the body. Standing recruits specialized muscles designed for low-intensity activity—muscles that are very rich in enzymes. The lipoprotein lipase enzyme  grabs fat and cholesterol from the blood, burning the fat into energy while shifting the cholesterol from LDL (the bad kind) to HDL (the healthy kind). When you sit, the muscles are relaxed, and enzyme activity drops by 90% to 95%, leaving fat to camp out in the bloodstream. Within a couple hours of sitting, healthy cholesterol plummets by 20%.

A Canadian study reached a similar conclusion. After adjusting for potential compounding factors (smoking, exercise levels, etc.), the study found that the longer people sat, the higher the risk of mortality from all causes except cancer.

The good news is that inserting breaks into your sedentary periods can help. Periodically taking time out from your computer, desk, television, and driving time to walk, move around, stretch, and flex your muscles, is good for you. These spurts of activity are associated with a smaller waist circumference, lower body mass index, and lower blood lipid levels, and better glucose metabolism.

A stand up desk might be a good idea as well. Don’t have room for one? Too expensive? Then pile some books or something else on top of your existing desk and put your laptop where you can type standing up when you want to, either often or as a break.

At ANH-USA, we believe that true health comes from a combination of diet (and supplements), exercise, and lifestyle. Politically, so much is happening regarding supplements and diet that we spend most of our newsletter space focusing on those areas. But science tells us that our lifestyle choices—simple decisions made daily—can make a huge impact on our health, for good or for ill.

Will it be enough to rein in FDA’s outrageous power grab?

ANH-USA, together with a number of supplement trade organizations, went to Capitol Hill to plead our case about the FDA’s profoundly flawed NDI (new supplement) draft guidance in the offices of two powerful senators and longtime friends of natural health, Sen. Tom Harkin (D-IA) and Sen. Orrin Hatch (R-UT). Our visit was preceded by all the letters you have been sending to Congress, which have immeasurably increased the visibility of this issue. As you know, if this draft guidance stands, it would allow FDA to arbitrarily deny the sale of any supplement created (or modified) in the past seventeen years. Immediately after this meeting, Sens. Harkin and Hatch wrote to FDA Commissioner Margaret Hamburg and formally asked the FDA to withdraw its guidance document.

The senators urged FDA to begin work on a new draft that provides needed clarification on what constitutes a New Dietary Ingredient (NDI)—but, in their words, does not undermine Congress’s desire to provide consumers with access to safe, affordable dietary supplement products. Exactly!

These senators were uniquely qualified to make such a request, since they were the principal authors of DSHEA, the Dietary Supplement Health and Education Act of 1994. “When Congress included language in the Food Safety Modernization Act (FSMA) directing FDA to clarify when a dietary supplement ingredient is a new dietary ingredient, the expectation was that the guidance would be consistent with DSHEA,” they write. “Unfortunately, the draft guidance serves to undermine DSHEA in a number of important respects.”

They go on to outline the various arguments that we have been making in these pages for some time:

• The requirement for a manufacturer to submit an NDI notification for every dietary supplement containing an NDI is directly contrary to the language of DSHEA, which requires notification only of the intent to use an NDI;
• This new requirement is burdensome and would impose substantial additional costs on manufacturers, would not provide additional safety benefits, and would undermine access to the safe, affordable nutritional supplements that DSHEA was designed to ensure;
• The NDI guidance’s assertion that synthetic copies of ingredients can never be a dietary ingredient is without any statutory basis, and is contrary to longstanding FDA policy; and
• This guidance is contrary to Congressional intent by grandfathering in only ingredients that were marketed before the enactment of DSHEA—such an argument is particularly specious since “the term dietary supplement wasn’t even defined prior to DSHEA”!

The senators requested that FDA meet with interested parties to work through all of the issues raised in our and others’ comments. Fortunately, FDA can’t just ignore the senators’ request, because the agency is required to work within legislative intent. Otherwise they would be creating new law—which legally they cannot do. This is one of the arguments we have been making all along—that FDA is in fact making new law with this draft guidance, and now Congress is calling them on it!

We would like to thank Senators Harkin and Hatch for being such stalwart champions of natural health, and for their leadership in this battle to prevent the FDA from usurping powers that they are not legally entitled to. We also want to thank every one of you for contacting Congress and the FDA and being such a vital part of this process.

We aren’t out of the woods yet—we’ll have another update soon with additional action items for you. The time may come for more specific legislative action, and we may find ourselves battling FDA in the courts as well. That’s why your continued support and activism is so terribly important. Together we can win this one, preserve your access to supplements, and keep supplements from costing as much as drugs.

Fox News.com featured a fantastic article about FDA’s anti-supplement new dietary ingredient guidance.  Please read, share, take action and leave comments.

Read more: http://www.foxnews.com/health/2011/12/20/is-fda-trying-to-take-away-your-vitamins/

Security breaches are up 32%—but because of a loophole, if your patient data is stolen, you may not even be told about it!

Why wouldn’t an identity thief love electronic patient records? They are a veritable goldmine. Each record contains the patient’s name, Social Security number, birthdate, contact info, and insurance, not to mention private health and treatment data. Security breaches cost the industry $6.5 billion dollars—most breaches occur when a computer is stolen—with the number of thefts increasing dramatically each year; this year there were 32% more breaches, the New York Times reported this week.

That 32% comes from data reported to the Department of Health and Human Services. But here’s the zinger: Federal law requires health organizations to report data breaches to HHS only if they affect more than 500 people. And it requires disclosure only in cases that “pose a significant risk of financial, reputational, or other harm to the individual affected.”

Who gets to decide this? The company that was handling the data—and was responsible for the breach. It’s in their own interest, of course, to minimize their exposure. So a record listing your name alone would be ignored; 499 complete records may be ignored; and any number may be ignored if supposedly not posing a risk of harm. In these instances, victims would never be notified.

The CDC says about 57% of doctors’ offices use electronic medical records (EMRs); just last year it was only 45%. EMRs are a requirement of the Affordable Health Care Act, and as more and more hospitals and healthcare systems begin to comply, the problem will only get worse in the future.

In October, a desktop computer containing unencrypted records on more than four million patients was stolen from Sutter Health, a nonprofit health system based in Sacramento. The theft is now the subject of two class-action suits, each of which seeks $1,000 for each patient record breached.

You may recall that ANH-USA has consistently opposed a nationwide mandatory electronic records system. We believe that 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. At the very least, patients should be able to opt out.

Another problem is that EMRs allow state medical boards to go on “fishing expeditions” targeting integrative physicians, because they can more easily search to see what treatments the physicians are using that may be outside some arbitrarily and vaguely defined “standard of care.” Fortunately, EMRs are only mandatory for doctors who participate in insurance or other federal programs; many integrative physicians do not take insurance and do not use EMR. Unfortunately this just means that the patients have to pay twice for healthcare, once for insurance they won’t use, and once in cash to the physician of their choice.

Of course, it’s not only electronic data that can fall into the wrong hands. In Minneapolis last month, sensitive medical information was found on the back of a child’s drawing she had made at elementary school—including the patient’s name, account number, birthdate, and job. An attorney’s office had donated old scrap paper to the school for an after-school program; the attorney had been hired by the patient after a car accident, and the office employee who made the donation didn’t think there was any personal information on the papers. The attorney apologized for the mistake, saying that the donation was a violation of the firm’s privacy policies.

The elementary school sent out a message to every child in the after-school program to check if any other medical records have ended up in students’ homes, and asked students to return them.

Of course, if some cyber-terrorist destroyed the electronic systems, then it might be nice to have paper records like the ones that ended up in elementary school.

The larger problem with government mandates is usually one of unintended consequences, especially when we are all forced into a one-size-fits-all pseudo-solution. If government would leave medical professionals alone, they might come up with more creative solutions to the record-keeping problem, solutions that protect our privacy and take into account our individual needs and wishes.

Pizza remains a vegetable and you can have as many greasy fries as you like, all thanks to Congress.

What kind of country allows what appears to be open financial corruption to poison its children’s school lunches? The answer seems to be our country.

Two of the biggest school lunch suppliers, together with their congressional lapdogs, are strong-arming the USDA. They’re the ones who twisted the regulations so that a slice of cheese pizza could be considered a vegetable, and made sure our kids’ lunch plates could stay filled with French fries. Meanwhile, the management companies responsible for administering the lunch programs are receiving what look to us to be kickbacks from food suppliers and distributors.

Last January, the USDA made a feeble attempt to improve the situation by making school lunches healthier through better Dietary Guidelines. As we reported then, the agency’s goals of including more vegetables and whole grains in the lunch program were laudable. But USDA officials didn’t pay attention to real nutrition research, and ended up advocating a diet that can actually make people obese.

Unfortunately, other government food programs also rely on USDA guidelines and have notably poor nutrition plans. For example, the government WIC (Women, Infants, and Children) program includes soy-based infant formula as an alternative to milk—despite the documented dangers to infants from soy chemicals mimicking estrogen or other hormones.

In general, the USDA, which seems more concerned with getting food sold than making our children healthy, gets a very poor grade as a nutrition advisor. But it gets worse. Far worse.

Congress just passed an appropriations bill including a particular rider (an additional provision added to a bill which has little connection to the subject matter of the bill) forcing USDA to change its feeble new guidelines in ways that further benefit special interests—and harm kids’ health. Serving the interests of giant food companies, the rider seeks to preserve pizza as a “vegetable” under the school lunch program and also to be sure that unlimited French fries can be served.

How exactly, you might wonder, can pizza be defined as a vegetable? In the school lunch program, most pastes and purees get credit for the “actual volume as served,” meaning that there must be half-cup servings to qualify, no matter how nutrient-dense they may be. USDA wanted the tomato paste on pizza to be treated the same way. But Congress carved out an exception for tomato paste and mandated that two tablespoons qualifies as a serving. Why exactly two tablespoons? Because that’s the amount that is used on a slice of pizza. In this way, a slice of cheese pizza gets to be counted as a serving of vegetables, courtesy of our esteemed Congress.

The new USDA guidelines also restricted the amount of starchy vegetables in lunches, which includes the potatoes used for French fries, and cut back on the amount of sodium allowed. The new rider overrides those new restrictions too, so kids can be served unlimited fries.

According to the Los Angeles Times, the American Frozen Food Institute, which supplies frozen French fries, was one of the heavy-hitters in getting the rider passed. Senators Susan Collins and Mark Udall, both from big potato-producing states, joined with the National Potato Council to fight the limits on starchy vegetables.

Schwan’s Food Service, which supplies frozen pizzas to 75% of US schools, is the corporate behemoth of the school lunch program. Sen. Amy Klobuchar, from Schwan’s home state, wrote a letter to Agriculture Secretary Tom Vilsack extolling the nutritional value of tomato paste. Schwan donated $4,000 to Rep. John Kline and $6,000 to Rep. Peterson—both of whom also fought to create the tomato paste exception.

In August, Schwan’s issued a press release claiming it “has been feeding America’s children at school for 36 years and is a leader in the $9.5 billion school foodservice industry.” They went on to talk about new options with more whole grains and fewer calories from fat, but then sang the virtues of pizza: “Pizza continues to be the choice of students for school lunch, and we’ve created great tasting products that provide the nutrition that kids need.” Well, some of us at ANH-USA have kids in public high school, and they report the pizza served there is the greasiest, sorriest, least-appetizing pizza they have ever seen. But let’s ignore that for the moment and go back to measuring tomato paste.

Clearly, for pizza to continue being counted as a vegetable, something had to be done about that new pesky half-cup serving guideline. So the lobbyists went to work, and the legislators did their bidding, apparently without worrying about the kids. Federal lobbying records show that Schwan and the American Frozen Food Institute spent $450,000 on congressional lobbying this year (though there are no specifics on what precisely they were lobbying for).

We wish this were all that is wrong with the school lunch program, but it isn’t.

The US Department of Agriculture pays $1 billion per year to buy produce and meat for school lunches. Instead of preparing that food on-site in a healthy manner, schools hire management companies, which in turn hire processors to prepare the food. The processors turn chicken meat, scraps, flavorings, and fillers of uncertain origin into things like chicken nuggets, etc. The processors in turn pay what look to us to be kickbacks to the management companies for choosing them over another processor. None of this money goes back to the schools. Those seeming kickbacks—the management companies would call them rebates—are arguably illegal. The New York Attorney General sued one management company and received a $20 million settlement.

Even if the school lunch system weren’t corrupt, it would still be unhealthy. In 2003, the USDA approved irradiated meat for the school lunch program. Since then, Congress has placed limitations on irradiated meat in school lunches, but it is still served.

Schools can’t even get something as traditional as chocolate milk right these days. Of course recent research does suggest that adding chocolate can make the calcium less bio-available, but let’s not fuss about that. Nor, for a moment, the growth hormones or the antibiotics in the milk itself that we have descried in other articles. But how about the BHT added to the chocolate milk? BHT is a preservative that is also used in cosmetics, pharmaceutical drugs, rubber and petroleum products, jet fuels, and embalming fluids. It causes cancer in animals, and can cause liver and kidney damage, but most notably causes behavioral problems and hyperactivity in children. Perhaps the supposition is that if Johnny acts up, we can just give him some drugs to calm him down (please see our article on that subject in this issue)!

Prozac and other SSRIs kill kids—and not just from suicide. A judge now agrees. New Action Alert!

Scientists and integrative doctors have been aware of these drugs leading to violence for years, but now it is also the ruling of a Canadian judge, who found that a teenager killed his friend because of a reaction to SSRI antidepressants. Meanwhile more and more kids are being “screened” and pushed to take these prescriptions.

In Winnipeg, Manitoba, Justice Robert Heinrichs concluded that a 15-year-old boy was under the influence of Prozac when he fatally stabbed a close friend. Although the boy pleaded guilty to second-degree murder, the judge cited the drug’s side effects as a reason to keep the case in juvenile court and give him a more lenient sentence.

Prozac is prescribed to curb depression, but as we reported in March, SSRIs are linked to a shockingly heightened risk of violence toward others. Not just suicide, which a black box warning on the package already warns against. But sudden, unexplained, and often murderous violence against others.

In the Canadian case, Justice Heinrich concluded the medication set off a steady deterioration in the young killer’s behavior. “He had become irritable, restless, agitated, aggressive and unclear in his thinking,” the judge said. “It was while in that state he overreacted in an impulsive, explosive and violent way. Now that his body and mind are free and clear of any effects of Prozac, he is simply not the same youth in behavior or character.”

In this case, the teenage murderer had a history of smoking marijuana, had abused prescription drugs, and “experimented” with cocaine. Ironically, it was to help him break free of these behaviors that a family doctor prescribed Prozac for depression.

Remember, the Columbine High School shootings and the spree shootings at a community center in Los Angeles, two brokerage firms in Atlanta, and a printing plant in Kentucky were all perpetrated by people taking Prozac, Zoloft, Luvox, Paxil, or a related SSRI antidepressant drug.

The US Food and Drug Administration and the Health Protection Branch (HPB) of Health Canada know all this. So why does the FDA require the warning against suicide on the drug package but no warning against acts of violence? It would seem that the FDA simply does not want to take any responsibility for the acts of mass violence in our schools and workplaces that have become increasingly common since the agency’s approval of these drugs.

Meanwhile doctors are not only prescribing more and more SSRIs to teenagers, but schools and educational agencies are also pushing teenagers to get mental health screenings. The “teen screen” program uses inducements like free movie tickets to coerce them into being screened, and then asks such questions as whether they ever feel insecure or depressed (what teen doesn’t?). Very often, the answer is more medication from these truly dangerous drugs.

Parents can object (if they hear about the screening in advance, which is not guaranteed), but if they do, they may be charged with child abuse, child neglect, or educational neglect!

Rep. Ron Paul has introduced the Parental Consent Act of 2011, which would prohibit the use of federal funds for any universal or mandatory mental health screening program for kids. HR 2769 also addresses the problem of educational institutions using a parent’s refusal to consent to mental health screenings for his or her child as the basis for a charge of abuse or neglect. Any school or agency that does such a thing would no longer be able to receive federal education funding.

Children shouldn’t be automatically screened for mental health issues without explicit parental consent, especially if there is no indication of mental health problems. It violates parental rights, the diagnostic criteria are vague, and federal funds shouldn’t support programs that could lead to the increased over-medication of children.

An identical bill has been introduced in the Senate, S 1800, by Sen. Rand Paul.

Please contact your senators and representative and ask them to support this extremely important legislation. Take action TODAY!

It wasn’t enough that they raised the price of this critical drug from $10 to $1,500 per dose. Now they are going after pharmacists and hitting pregnant low-income women the hardest.

KV Pharmaceutical Company is trying a new approach to corner the market for their drug Makena, which helps prevent premature births. They are “raising concerns” about the quality of 17P (17-Hydroxyprogesterone), a hormone that forms the active ingredient in the drug that has been used for many years by compounding pharmacies to make a low-cost version of the pregnancy medicine. The FDA has now agreed to investigate.

You may recall from our earlier article that KV took a compounded drug costing $10 per dose, patented 17P, got it approved by the FDA under the Orphan Drug Act, and immediately raised the price to $1,500/dose (or as much as $30,000 over the course of a pregnancy). When the media picked up this story, KV Pharmaceutical eventually lowered its price from $1,500 to $690 per dose—but that’s still an absurd price when the compounded version only costs $10.

KV then sent letters to compounding pharmacists, telling them they must stop selling their versions of the drug or else face FDA enforcement actions! After an outpouring of protests from you and other grassroots supporters, the FDA was forced to officially concede that this was in fact not the case.

Last month, KV Pharmaceutical presented FDA with data that claims there is variability in the purity and potency of the bulk ingredient and compounded forms of 17P. However, KV has refused to make this data publicly available, so it is impossible to verify their information. FDA has agreed to look into KV pharmaceutical claims and will conduct an on-site review of the laboratory that makes the bulk ingredient.

By resorting to such bullying tactics, the drug company seems to be trying every approach it can to stamp out competition. Their questioning the quality of compounded drugs is especially ironic considering their own credibility is on the rubbish heap. This past week, the drug-maker agreed to pay $17 million as a settlement for violating the False Claims Act—the company failed to advise the Centers for Medicare and Medicaid Services that two of its drugs were unapproved and didn’t qualify for coverage. Besides selling unapproved drugs, they also admitted to making false claims and sending out false quarterly reports.

Remember last week’s article about the government receiving settlements in lieu of prosecution, because the government doesn’t want to lose the drug companies’ business? Another week, another example of drug company crony capitalism.

This comes just seven months after Marc Hermelin, the former chairman and CEO of KV, pleaded guilty to presiding over the production and distribution of morphine sulfate tablets that were larger and contained more morphine than they were supposed to; other tablets were of irregular sizes. He himself was ordered to pay a $1.9 million fine.

Compounding pharmacies have been compounding 17P since 2000, with no controversy. So while KV attempts to bolster the price of its stock, now worth 5% of what it was worth four years ago (this year alone it has fallen from over $12 a share to its current $1.75 a share), its latest stratagem appears to us to be a calculated attack on compounding pharmacists and pregnant women—many of them low-income women without insurance who have no way of paying the exorbitant price of Makena.

Bolstered by a massive outpouring of support from you, we are asking the agency to withdraw its New Dietary Ingredient (NDI) draft guidance completely!

The period for comments to the FDA on the draft guidance on NDI notifications closed on December 2. Along with the hundreds of thousands of messages you sent and the 20,000 phone calls you made to FDA and Congress, ANH-USA also submitted formal comments.

The problem with the FDA’s draft guidance on New Dietary Ingredients is that it allows FDA to arbitrarily deny the sale of any supplement created (or modified) in the past seventeen years. If you’re a supplement manufacturer or distributor or possibly even a health food store, and you don’t file a NDI “notification” (actually a request for approval) for each ingredient in each product developed since 1994 in just the way prescribed by the FDA, and the court later decides the FDA is right, then you are guilty of product “adulteration,” which is punishable by prison. With your favorite supplements off the market, it also would allow the drug industry to adapt and patent them, and sell them back to you—by doctor’s prescription only—for 10 or 100 (or even more) times what you’re paying now.

Our comments, drafted by acclaimed attorney Jonathan Emord on our behalf, show that the FDA is engaged in substantive new rulemaking, in violation of the federal Administrative Procedure Act (APA). “The APA says if an agency’s action is legislative in nature, that’s rulemaking,” explained Emord. “The guidance distorts the plain language of the laws that govern supplements. FDA needs to comply with the APA’s formal rulemaking requirements, not issue unilateral guidance as a deceptive means of creating new rules.”

We argue that the FDA is acting illegally. The FDA circumvented the regulatory process by issuing a guidance, which gives them cover and flexibility, instead of going through the rulemaking process, which is required when creating a new law—and we believe the guidance in fact does create new law. As a result, FDA’s actions leave interested parties little recourse within the regulatory system.

In technical terms, a guidance is supposed to be legally non-binding. It is meant to simply present the FDA’s interpretation of the rule. However, the NDI guidance goes well beyond an interpretation, and we believe it is in fact a legislative rule with legal implications:

• The NDI guidance is a departure from the FDA’s previous standards for NDI notifications. It alters and broadens the meaning of what qualifies as an NDI, and creates new—and very expensive—requirements to comply with the NDI notification process (creating what we would call a de facto pre-approval system), counter to what is outlined in Dietary Supplement Health and Education Act (DSHEA).
• Not fulfilling the NDI notification requirements outlined in the guidance ensures that the supplement will be considered adulterated and therefore illegal. This indicates there’s a clear, legally binding impact to the NDI guidance.
• Supplements that are considered illegal can be confiscated, and under the Food Safety Modernization Act, as we noted lasted week, can now be subject to administrative detention as well.

You may recall that Joanna M. Shepherd Bailey, PhD, professor of law and economics at Emory University, demonstrated that FDA grossly underestimated the economic cost of the NDI guidance. Her report found that:

• Between 22,240 and 41,700 nutritional supplements would likely be removed from the market, at an economic loss of between $5.6 billion and $10.5 billion;
• The nutritional supplement market could shrink by between 28% and 52.5%, producing an annual loss for the industry of between $7.84 billion to $14.7 billion; and
• Between 55,720 and 104,475 jobs in the supplement industry could be lost.

FDA’s analysis did not take into consideration the costs of the expanded reach and requirements of the NDI guidance. The agency therefore misled the Office of Management and Budget, in violation of the Paperwork Reduction Act of 1996.

FDA has arbitrarily determined that supplement companies need to show at least “25 years of widespread use” in order it to meet the “history of safety” standard in NDI notification. In other words, only supplements on the market before October 1986 could be considered “safe.” This is patently ridiculous, since the cutoff date for grandfathered ingredients assumed to be safe, according to DSHEA, is October 1994.

The NDI notification system was intended to ensure safety. The very reason pre-DSHEA supplements were grandfathered is because they had proven themselves safe through years of use by hundreds of thousands of consumers! If safety is of utmost concern to FDA, why does the guidance document burden the supplement industry with regulatory requirements that have nothing to do with proving the safety of the supplements? It appears FDA is acting out of spite—and not in the public’s best interest. Moreover, many of the provisions in the guidance are totally unrelated to safety and serve only to limit consumers’ access to nutritional supplements.

We believe FDA will be unable incorporate enough changes to their draft guidance to bring it in line with existing law, preserve supplement access for customers, and remove needless regulatory hurdles for industry. Because of this, we asked FDA in our formal comments to withdraw the draft guidance at the earliest possible moment.

Now that the FDA’s comment period is closed, the agency is supposed to review the comments and prepare a final version of the guidance document—though they are under no legal obligation to do so. In fact, because it is guidance, they are under no legal obligation even to take public comments into consideration. Nor is there any timeline: the agency is still sitting on a guidance, now nearly three years old, that was meant to create a distinction between beverages and liquid dietary supplements.

Even worse, since this is presented as guidance and not formal rulemaking, the FDA is very likely to enforce the provisions in the draft guidance as though they were final—with limited legal recourse for affected parties!

We believe FDA’s actions require them to follow the Administrative Procedure Act, which calls for a formal rulemaking procedure. Under this law:

• FDA will be forced to have a formal comment period, and to review and consider all comments before they issue a final rule. This includes a rulemaking record that shows the data and analysis behind a proposed rule, and sometimes even public hearings.
• If the result is not to the liking of interested parties, “Each agency shall give an interested person the right to petition for the issuance, amendment, or repeal of a rule.” This means, that unlike a guidance, it is possible to challenge a rule in court. It is very likely that FDA conveniently issued a guidance, instead of going through the rulemaking process, to avoid this very outcome.

Now that the NDI comment period is closed, we will start implementing the next phase of our strategy—which will include both legal and legislative components. We will, of course, keep our supporters and allies in the loop.

Thank you all again for your tremendous outpouring of letters and phone calls! It has laid important groundwork for our next actions.

So why does the government keep blocking its use?

Research from health pioneer (and former ANH-USA board member) Dr. Paul G. Harch published in the Journal of Neurotrauma indicates that hyperbaric oxygen therapy, or HBOT, is able to dramatically help veterans with post-concussion syndrome (a form of traumatic brain injury) and post-traumatic stress disorder (PTSD). Dr. Harch is an associate clinical professor of medicine at Louisiana State University in New Orleans.

Since January 2007, ANH-USA has been bringing attention to a project to have veterans treated with HBOT. In HBOT, the patient is put in a hyperbaric oxygen chamber, which saturates the tissues with twelve times more oxygen than can be absorbed by breathing. This greatly enhances the body’s own healing process.

Under normal circumstances, oxygen is transported throughout the body only by red blood cells. With HBOT, oxygen is dissolved into all of the body’s fluids, the plasma, the central nervous system fluids, the lymph, and the bone, and can be carried to areas where circulation is diminished or blocked. In this way, extra oxygen can reach all of the damaged tissues and the body can support its own healing process. The increased oxygen greatly enhances the ability of white blood cells to kill bacteria, reduces swelling, and allows new blood vessels to grow more rapidly into the affected areas. It is a simple, non-invasive, and painless treatment.

According to Dr. Harch’s new study, even three years after the vets sustained brain injury, one month of HBOT was able to induce improvements in brain blood flow, cognition, symptoms, and quality of life, while the veterans experienced fewer suicidal thoughts.

Specifically, improvements were seen in 92% of vets experiencing short-term memory problems, 87% of those complaining of headaches, 93% of those with cognitive deficits, 75% with sleep disruption, and 93% with depression. There were also improvements in irritability, mood swings, impulsivity, balance, motor function, IQ, and blood flow in the brain, as well as the reduction in PTSD symptoms and suicidal thoughts. And there was a reduction in—or complete elimination of—psychoactive and narcotic prescription medication usage in 64% of those previously prescribed the medication.

One major problem is that the HBOT treatment is currently “off-label.” In other words, it is an FDA-approved treatment for some conditions—but not for traumatic brain injury (TBI) or PTSD. Because of this, the Department of Defense does not allow HBOT to be prescribed for its veterans—they say they don’t prescribe off-label medications and treatments for these diagnoses, and claim that they can only use HBOT after it has been approved by the FDA for this use.

This is a completely false and misleading statement! The Department of Defense often uses off-label antipsychotic drugs for treatment of TBI and PTSD. This should not surprise us. The FDA receives a large proportion of its budget from pharmaceutical manufacturers. And the government turns to drugs, often very inappropriate and damaging drugs, to treat damaged veterans without even considering alternatives.

Nearly 280,000 individuals received antipsychotic medication in 2007. Yet over 60% of them had no record of a diagnosis for which these drugs are approved. Antipsychotic drugs were prescribed off-label for PTSD (42% of the patients), minor depression (40%), major depression (23%), and anxiety disorder (20%)—with about 20% having more than one condition. About 20% of veterans diagnosed with PTSD—or nearly 87,000 patients—are prescribed an antipsychotic each year even though it is an off-label use.

TBI and PTSD severely and disproportionally affect military who have served in Iraq and Afghanistan—approximately 546,000 have TBI, post-concussion syndrome (PCS), and PTSD, and yet their treatment options are limited. HBOT is an effective and economical treatment for PCS and PTSD, without the very dangerous and negative side effects of antipsychotic medication.

The off-label use of HBOT is a huge freedom of choice issue in medicine. But even more important, if we really want to support our troops rather than just pay lip service, don’t we need to give them the safest, most economical, and most effective treatment for their traumatic brain injuries and PTSD?

There is a surprising reason why the government won’t go after drug companies for serious crimes.

It is because government programs like Medicare, Medicaid, and the Veterans Administration would then be barred from doing business with them!

In 1999 the FDA approved Vioxx, a drug created by Merck and Co. to treat arthritis. Vioxx was pulled off the market in 2004 because evidence showed it greatly increased the risk of heart attack in the 25 million Americans who had taken the drug. Some 50,000 patients sued, and 27,000 of the plaintiffs received $4.85 billion in settlement of their claims.

Last week the Department of Justice announced that Merck has agreed to pay a $321 million criminal fine and plead guilty to one misdemeanor count of illegally introducing a drug into interstate commerce. Merck also is paying $426 million to the federal government and $202 million to state Medicaid agencies. Those payments will settle civil claims that its marketing caused doctors to prescribe and bill the government for Vioxx they otherwise would not have prescribed.

Please note that these settlements are for rather minor infractions—not for deliberately concealing the danger of a killing drug from patients, the medical community, and their investors. Despite the serious consequences of Merck’s actions, the government won’t prosecute them for any serious charges—because, if they did and won, it would mean they would have to stop doing business with Merck in the future! Federal law makes it illegal for Medicare and Medicaid to do business with “an excluded or debarred entity resulting from serious criminal charges.”

This means that when a company becomes too deeply enmeshed in the government’s business, these companies simply become too big to prosecute!

Paying fines without serious criminal charges does not appear to be enough of a deterrent. A new report from the consumer group Public Citizen shows that the pharmaceutical industry now leads all other industries in fraud against the federal government—and that includes the defense industry! Big Pharma led the pack in the total amount of fraud payments for actions against the federal government under the False Claims Act. Four companies (GlaxoSmithKline, Pfizer, Eli Lilly, and Schering-Plough) accounted for more than half (53 percent or $10.5 billion) of all financial penalties imposed over the past two decades.

In 2006, Dr. David Graham, associate director of the FDA’s Office of Drug Safety and a courageous whistleblower, said in an interview, “The FDA is responsible for 140,000 heart attacks and 60,000 dead Americans. That’s as many people as were killed in the Vietnam War. Yet the FDA points the finger at me and says, ‘Well, this guy’s a rat, you can’t trust him,’ but nobody is calling them to account. Congress isn’t calling them to account. For the American people, it’s dropped off the radar screen. They should be screaming because this can happen again.”

If a supplement killed 60,000 Americans, what do you think the reaction would be? It would be pulled from the shelves, the FDA would outlaw it, and the media would be screaming about the dangers of supplements. Vioxx does the same thing, and the FDA gives Merck a slap on the wrist and gets a financial settlement.

As Public Citizen told NPR, “The current system of prosecution and recovery isn’t working, because companies can take even the biggest settlements in stride. What’s needed is more criminal prosecution—and the prospect of jail time for Pharma executives.”

ANH-USA is not trying to put anybody in jail. But if we pass laws, they should apply to everyone, including members of Congress and big companies, whether on Wall Street or in the drug industry. Crony capitalist arrangements between government and special interests should never be allowed to create a special category of “too big to prosecute.”

ANH-USA has launched a campaign to raise funds for the Natural Health Alliance Foundation.

The Natural Health Alliance Foundation works to educate the public about a natural approach to health and healing, and promote the free flow of information about natural health, through a variety of educational and legal projects. Through grants, NHAF supports much of ANH-USA’s work, including supporting the Pulse of Natural Health newsletter and many of our court challenges against the FDA and other government agencies.

NHAF is a 501(c)(3), nonprofit organization, which means that donations are 100% deductible!

As a special bonus, ANH-USA is offering special gifts for donors who pitch in towards meeting our December 31 fundraising goal. Please make your gift today!

One of the benefits of being part of an international organization is the invaluable insights we’re able to gain from having colleagues overseas at ANH-Europe.

In many areas of health practice and education, the European model is greatly restricted when compared to the US model. This means we can often look to what has already happened in Europe if we want to understand the consequences of many of the laws and regulations proposed here in the United States, as the laws and regulations often mimic those already in place in in the European Union.

This week, a special feature from ANH-International takes a look at what’s happening with supplements in the USA, how it mirrors the European model, and why that spells bad news for American supplement consumers. We think our readers will find this piece informative and illuminating, and help you to better understand the challenges we face here in the USA:

ANH Feature: Is the USA setting itself up to squeeze out dietary supplements like in Europe?

(If you enjoy the international perspective, be sure to sign up for weekly e-blasts from ANH-Europe. Together with The Pulse of Natural Health, these weekly newsletters provide a comprehensive look at all things related to natural health around the world.)

Their latest move targets supplements while giving drugs and vaccines a free pass. New Action Alert!

Senator Dick Durbin and Congressman Henry Waxman are trying a new tactic in their attack on supplements after previous legislative failures. They have asked the Government Accountability Office (GAO) to review adverse event report data—but only for supplements. The GAO operates at the call of Congress, so some action on this request is inevitable. Here is their letter.

In a statement, Sen. Durbin said, “The FDA has the tools necessary to determine which supplements can cause and have caused severe health problems—they should use them effectively.”

This is nonsense. There is no evidence that legitimate supplements, those that comply with existing law, have caused severe health problems. What the FDA needs to do is not evaluate and approve each supplement, but rather enforce existing law.

Durbin’s idea that the FDA has the expertise to evaluate all supplements is pure fantasy. They aren’t set up for it and would fail even if they were. The agency is biased against supplements to boot, because it wants them to go through the drug approval process and thereby contribute to the agency’s budget. Supplements, not being patented, cannot afford all these costs, as the FDA and Durbin and Waxman know well. The end result of this mindset will simply be to clear the shelves of supplements.

If consumer safety is really Sen. Durbin’s motivation, we have to ask—why aren’t he and Rep. Waxman also asking the GAO to review adverse event report (AER) data for vaccines and drugs, which are far more dangerous and have far more reported adverse events? Just look at the number of adverse events reported for 2008 alone:

• Supplements: 1,080 adverse events, of which 672 were considered serious;
• Vaccines: 26,517 adverse events, of which 3,923 were considered serious; and
• Prescription drugs and “therapeutic biologics”: 526,527 adverse events, of which 275,421 “had serious outcomes.”

Note that the above figures should be used with caution. Although a serious adverse event is defined by statute, other adverse events are not.  What may be considered an adverse event for one category may not be for another. If an FDA-approved drug has listed in the product labeling that it can cause fainting or nausea, or chest pains or seizures, then it is considered to be within the range of expected outcomes! In this case, the adverse event should be reported, but the report is not considered “urgent” and may be delayed for up to a year.  At the same time, USA Today noted, when it comes to supplements, what the FDA considers an adverse event can be “anything from a concern that a supplement isn’t working to a serious illness that follows consumption.”

Please note also that while the vaccine data we reported above comes from a separate Vaccine Adverse Event Reporting System, the prescription drugs figures may or may not include vaccines, since vaccines are technically therapeutic biologics. The government doesn’t say.

What is clear, however is that there are over 487 times more AERs for FDA-approved prescription drugs than there are for supplements, and 409 times more serious events for drugs than supplements. And Durbin thinks it’s supplements that are endangering the public? The following graph makes the difference obvious:

Ultimately, these latest tactics are meant to move us closer to a pre-approval regulatory system for supplements, which will remove many—or perhaps most—supplements from the market, giving even greater power to the pharmaceutical industry.

We believe that Congress shouldn’t look into supplement AERs unless they actually pay attention to major vaccine and drug AERs. The lack of attention to vaccine AERs is a particular scandal, as we pointed out in an earlier story about the cover-up of HPV vaccine adverse events. As you may recall, the Institute of Medicine says it will only look at peer-reviewed research on vaccine AERs, but won’t sponsor any. They then conclude that vaccines like the dangerous HPV shots are “safe” because there is no “evidence” otherwise. If we lived in a sane world, this kind of Orwellian logic wouldn’t be allowed for a moment.

We are in discussion with several Capitol Hill legislators to get GAO to investigate and review drug and vaccine AERs if they do supplements—and we’re asking you to write your senators and your congressional representative and make the same request. Please take action today!

“Vitamin D Warning!” says MSNBC. “High Vitamin D Levels Linked to Serious Heart Condition” says Fox. What could be behind these terrifying headlines?

A new study says that taking excessive amounts of vitamin D may cause atrial fibrillation (AF). The research, presented at the annual meeting of American Heart Association, says that people who take too much vitamin D were 2½ times more likely to develop AF.

Well, not quite. That’s what the media have been saying the study says. But it didn’t. It says that in their study of 132,000 patients, AF was found in 1.4% of the study participants whose levels of vitamin D were normal, and in 3.8% of those whose levels were excessive. But the journalists couldn’t even get the basic facts straight. All the articles contained the same blunder that rendered the data meaningless. Everyone rushed ahead, relying only on the press release or the abstract, where the error originated, without waiting for the study itself to be published in the future.

The amount of vitamin D in the blood is measured in ng/ml—that is, nanograms of the vitamin per milliliter of blood serum. The press release and the study abstract both say, erroneously, that problems arise when vitamin D levels go over 100 ng/dl—that is, nanograms per deciliter. That’s the equivalent of 1 ng/ml. To say that 100 ng/dl is “excessive” is beyond absurd; anything under 30 ng/ml is considered deficient, and 1 ng/ml is next to impossible to achieve! A quick check with the study authors would have corrected that error—which means the journalists knew nothing whatsoever about the subject, and didn’t bother to do any research.

Besides, after correcting for this gross error, there is no real story here—the study merely confirms what scientists already thought:

• Under 30 ng/ml of vitamin D is clearly deficient;
• 30–100 ng/ml is the safety range;
• Over 100 ng/ml, and your risk starts to grow.

The optimum level of D is more often debated. The scientists who seem to us most expert on the subject think that 60 to 80 is optimal.

The authors of this study say the optimum range is 40–80. The trouble with 40 as an optimum is that it probably won’t protect you from getting a virus, although you should be able to handle it better than if your level is lower.

Why is a level over 100 ng/ml ill-advised? The best known risk relates to calcium. Vitamin D promotes calcium absorption in the gut; too much vitamin D results in too much calcium in the blood, or hypercalcemia, which can cause nausea, constipation—and sometimes, yes, even atrial fib. The study authors clearly state, however, that “the extent to which 25[OH] Vit D excess may be associated with AF is unknown.” Moreover, while AF was found 2½ times more often in people with levels of D above 100 than with levels of 80 and below, it’s still not a large percentage—only 3.8% of patients.

Please note that there’s no magical cut-off where you have to race to the hospital if you take too much D. The higher your blood serum level goes over 100, and the longer you’re there, the greater your risk. According to the Vitamin D Council, what exactly constitutes a toxic dose of vitamin D has yet to be determined, though published cases of toxicity, for which serum levels and dose are known, all involve a consistent intake of at least 40,000 IU per day.

It’s really a case of “too much of a good thing,” as Shakespeare put it. There are very few substances under the sun which, when consumed to excess, won’t harm you in the end. Medicines, whether of the natural and herbal variety or the patented and pharmaceutical variety, are dose-sensitive. A few aspirins once in a while (or better yet, white willow bark) can relieve headaches and reduce inflammation; taking a whole bottle will kill you. Heck, even drinking too much water will kill you.

But the media emphasis on too much vitamin D in your system is wrong-headed. The real problem, as indicated by the study, is too much calcium. As we have discussed before, taking calcium without the co-factors has been shown to be bad for the heart—you need vitamin K2 and omega-3 fatty acids (and, for other reasons, magnesium too). Did the news stories mention that?

So if the vitamin D toxicity doesn’t occur until one has clearly overdosed on the stuff for quite a while, why all the scary headlines? “High dose vitamin D pills ‘can double heart condition risk’ ” says one headline. “High vitamin D levels linked to heart condition” says another. Or worst of all, The Atlantic Monthly’s story on the subject, “Are Supplements Killing You? The Problem With Vitamins, Minerals,” started off with this teaser: “In two recently published studies, researchers suggest that supplements can do more harm than good if taken in addition to a healthy diet.” Outrageous horse-pucky.

Another study presented at the same AHA annual meeting, analyzing sixteen years of data gathered from more than 2,000 healthy, postmenopausal women, found a direct correlation between low vitamin D levels and heart problems. About 15 percent of the women with low vitamin D levels either died or suffered heart failure, a heart attack, or stroke during the study period.

Which study do you think got more press attention? You guessed it—the one that was thought to imply that vitamins were dangerous. Which of course was not what the study said at all. For more on what this study really said, you can read the Vitamin D Council’s analysis on their website.

Besides the scramble for ratings and web page “hits,” is anything else behind this anti-vitamin bias? The pharmaceutical industry is investigating a number of different synthetic versions of vitamin D, all of which are being investigated as treatments for various kinds of cancer. Two of them were complete failures. Two others—one specifically for prostate cancer, the other to be used in conjunction with standard chemotherapy—are showing promise. Interestingly, one of the researchers on the panel that produced the IOM’s anti-scientific vitamin D report sits on the Board of Directors for one of the companies working on the vitamin D drug—a high-potency formulation of intravenous vitamin D.

That’s the one–two punch preferred by the pharmaceutical industry and its media partners: first, pretend the vitamin either doesn’t work at all, or will kill you if you take too much of it, and scare off the public; then, reformulate the same vitamin into a drug that can make you millions of dollars. Let’s not forget that much of the major media is currently on financial life support and the support that keeps them alive is coming from Big Pharma.

The worst part of what may be a drug company campaign against supplemental vitamin D—and the media headlines warning about the dangers of “excess D”—is that at least one-third of all Americans are actually deficient in vitamin D. Besides causing heart problems in older women, vitamin D deficiency can cause chronic pain, weak bones, frequent infections and illnesses, diabetes, depression, and even cancer. In proper amounts, vitamin D is a potent immune system booster, maintains your calcium balance, helps regulate insulin and blood pressure, and may protect against osteoporosis, cancer, and Alzheimer’s.

And of course we have long advocated vitamin D as being the healthy alternative to the dangerous mercury-infused flu shot. It also short-circuits inflammation that can lead to flu-related complications such as bacterial pneumonia or lung infection. Want to be protected from colds and flu this season? Take proper amounts of vitamin D.

So what’s the proper amount? How do you get enough, but not too much?

Vitamin D supplementation depends on the region where you live, your exposure to sunlight, and your body’s particular ability to synthesize vitamin D3. The only sure-fire way to know if you’re getting enough vitamin D is to have a blood test. Your doctor can do it, or you can go to an independent lab, or you can purchase an easy-to-use in-home test kit and test the levels yourself.

The Vitamin D Council has an in-depth discussion of adequate doses of supplemental vitamin D3, but notes that children and adults with chronic health conditions such as autism, MS, cancer, heart disease, or obesity may need twice as much for proper health support. They emphasize that the doses they suggest are just to get you started. There is no substitute for a blood test to help you determine your body’s unique needs.

Want foster kids to behave? Give them harsh tranquilizers developed for schizophrenic patients!

According to a shocking new study published in the journal Pediatrics, foster children are being prescribed cocktails of powerful antipsychotic drugs, even if they’re not mentally ill and they don’t have any psychiatric symptoms. In fact, they’re given the drugs just as frequently as some of the most mentally disabled youngsters on Medicaid.

Kids in foster care with behavior problems are being given two antipsychotic drugs at once, according to the study. The drugs include Risperdal, Seroquel, and Zyprexa (and if you want to see something terrifying, just look at the list of Zyprexa’s side effects!). The drugs were developed for schizophrenia and severe bipolar disorder. But schizophrenia and bipolar disorder are extremely rare in young children, and the foster children in question did not have any psychiatric symptoms. They just came from bad homes.

Note that these drugs were never tested on young people during the FDA trials—and certainly not on people with developing brains. The latest research says the brain is still developing into one’s 20s. Foster care ends at age 18.

The New York Times reports that doctors and policy-makers have, in recent years, grown concerned about high rates of overall psychiatric drug use in the foster care system, the government-financed program that provides temporary living arrangements for 400,000 to 500,000 children and adolescents. Previous studies have found that children in foster care receive psychiatric medications about twice as often as kids outside the system.

The new study focused on one of the most powerful classes of drugs, antipsychotics, which are increasingly being used as all-purpose drugs for almost any psychiatric symptoms.

These same drugs are being used on veterans with post-traumatic stress disorder and traumatic brain injuries—when instead, as we have reported previously, they should be treated with hyperbaric oxygen therapy.

Antipsychotic drugs are responsible for many of the suicides among our soldiers. In fact, medications were involved in one-third of the record 162 suicides by active-duty soldiers in 2009. These drugs are extremely difficult to stop, because withdrawal often causes psychotic breaks. (That’s right, antipsychotic drugs can cause psychotic breaks.)

And these are the drugs we’re giving troubled children who were removed from bad homes!

Even if the antipsychotic drugs don’t cause the very mental disorders they’re supposed to help or produce the most frightening side effects, the study authors said that the drugs cause rapid weight gain and increase the risk for metabolic problems in many people, an effect that may be amplified by the use of two at once. Diabetes and obesity are the greatest health hazards children are facing—and these are the drugs we’re giving them?

It’s one thing for adults to rely on pills to cure their own ills. But giving kids from broken homes powerful psychotropic drugs just to keep them compliant is unconscionable.

The pioneering cancer doctor is a target once again. But you can help stop the attack.

Stanislaw Burzynski, MD, PhD, is a biochemist practicing in Texas who developed (using his own money) a nontoxic gene-targeted cancer therapy called antineoplastons. It has been shown to effectively help cure some of the most “incurable” forms of terminal cancer.

Dr. Burzynski had tried to get the FDA to review and approve antineoplastons since 1977, to no avail. To make sure he would not get into trouble for using the experimental therapy in his practice, his legal team confirmed that he was acting within the law and could use antineoplastons in his own practice “to meet the immediate needs of patients.” But in the 1980s the Texas Medical Board (TMB) charged him 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 TMB came up empty-handed.

We have reported on the TMB’s pattern of harassment against integrative doctors a number of times, discussing serious allegations from the Association of American Physicians and Surgeons, the serious attacks on Dr. Bill Rea’s work in environmental medicine and chemical sensitivity, and on Texas Governor Rick Perry’s involvement in appointing board members who actively harass integrative physicians.

As Dr. Joseph Mercola reported in June of this year, the FDA, the pharmaceutical industry, and the National Cancer Institute all knew how promising Dr. Burzynski’s therapy was proving to be. Standard cancer treatment is based on very expensive machines and very expensive toxic drugs. There is an enormous amount of money to be made in this paradigm, and Dr. Burzynski’s work single-handedly threatened to overturn much of it. On the other hand, this treatment showed such promise that they wanted to get their hands on it themselves.

So first they tried to copy his invention using a single non-patented ingredient, and when that failed, they tried to steal his patents out from under him. However, they knew they couldn’t use the stolen patents so long as he had the ability to defend his rights. So the government spent over $60 million to prosecute him on 75 counts of violating federal law, hoping to tuck him away in jail for the rest of his life.

For the next ten years, Dr. Burzynski was engaged in a lengthy and convoluted legal battle with the FDA. After two trials, he was found not guilty on all counts, and his antineoplastons medication is currently undergoing the FDA approval process. His fight was chronicled in a stunning documentary film, Burzynski: The Movie. More info on the documentary can be found at the film’s website, while the movie itself can be viewed online for a limited time.

Now the Texas Medical Board is back. The TMB is making yet another attempt to revoke Dr. Burzynski’s medical license which, if successful, would result in the closure of his clinic, the abandonment of all his patients, and would squelch any possibility of antineoplastons gaining FDA-approval.

Using the death of two of his terminally ill patients as a pretext, the TMB is charging Dr. Burzynski with the off-label use of FDA-approved drugs. It must be stressed, however, that Dr. Burzynski uses the drugs off-label in order to tailor the medication specifically to an individual’s genetic profile, rather than using a one-size-fits-all approach. Dr. Burzynski takes blood and tissue samples from his patients to form their molecular profile. From that he chooses from wide variety of existing FDA-approved drugs to tailor his gene-targeted therapy to his patient’s genetic profile specifically.

Multi-agent targeted gene therapies are the way of future. The American Society of Clinical Oncology has stated that they want to focus on “targeted therapies and personalized diagnosis and treatment” over the next decade. Dr. Burzynski is the only one who is using such a treatment on patients today.

The TMB’s complaint concerns a patient who had triple-negative breast cancer, had already undergone conventional cancer treatment without success, and initially felt better after Dr. Burzynski’s treatment and was able to return to work. The board is charging Dr. Burzynski over the side effects of his treatment, though they do not seem concerned with the horrible side effects she experienced with the conventional cancer treatments.

The complaint also concerns a patient with estensioneruoblastoma, a cancer so rare that any medication use would have been “off-label” since there is no recognized treatment for this disease at all. The patient lived for five more years and the tumor decreased in size by 40%, but the TMB complaint is charging that the disease actually progressed during his treatment.

The off-label use of FDA-approved drugs is not uncommon, and it is legal. According to the American Cancer Society, a study showed that 8 out of 10 cancer doctors surveyed had used drugs off-label. And half of the chemotherapy drugs used are for conditions not listed on the FDA-approved drug label.

Please take 20 minutes to watch this brand-new video on the upcoming court case, and share it with friends. Not only does it outline the charges involved in this case, but it also gives you a glimpse at a new side of Dr. Burzynski’s treatment. You’ll be shocked at how flimsy the TMB’s case is—and how doggedly persistent the board is in harassing Dr. Burzynski and others like him.

The Texas Medical Board v. Stanislaw Burzynski trial will begin on April 11, 2012. Please write to Gov. Rick Perry, who appointed a number of members of the TMB, including its heads, as well as the House Committee on Public Health and the Senate Committee on Health and Human Services, which oversee the TMB. This is about our right as citizens to choose our own cancer treatment—and not allow decades of important gene-targeted cancer research be flushed down the drain in the name of protecting the profits of an industry that doesn’t want Burzynski to survive. Please take action today!

They call our statements “erroneous,” “ridiculous,” “untruths,” “falsehoods,” and “outright lies,” but each of our “wild accusations” are solidly documented!

Last week we ran an article about ReallyEatRight.org, a website designed to shine light on the American Dietetic Association’s partnership with the junk food and pharmaceutical industries and its attempts to monopolize nutrition services. In response, Dietitians in Nutrition Support (a dietetic practice group of the ADA) posted a counter-attack, which contained a letter signed by the president of the ADA, accusing us of presenting a “one sided and misleading portrayal of ADA” and of having “a hidden agenda.”

Our agenda is open and transparent. We want the ADA to stop fueling the obesity and diabetes epidemic through their associations with Coca-Cola (allowing Coke to create a program about “urban myths” about the safety of food ingredients, which concluded that fluoride, sugar, artificial colors, and non-nutritive sweeteners are perfectly fine for children), cereal manufacturers General Mills and Kellogg’s, candy maker Mars, and Unilever, the multinational corporation that owns many of the world’s consumer products brands in foods and beverages.

The chair of the ADA practice group, whose focus is on giving nutrition support to individuals in inpatient and outpatient settings, including home care and pediatrics, said, “ANH has criticized ADA in the past—and will likely do so in the future—for our alleged efforts to suppress ‘nutritionists’ from earning a living.” (Notice those condescending quotation marks around “nutritionists”?) Well, that’s the other part of our open and transparent agenda: We want the ADA to stop convincing state legislatures that only dietitians can dispense nutritional counseling at the state level.

Any state licensure scheme that embraces ADA certification standards exclusively is by definition monopolistic and eliminates competition in the field of nutrition. Please note also that ADA certification only requires a college degree while many of the nutritionists we are defending have masters’ degrees and PhDs in this field.

The group goes on to say that “ADA has made a decision not to reply to every wild accusation that is leveled against the Association,” and instead they reprint a letter that former ADA president Judith Rodriguez, PhD, RD, LDN, FADA, sent to ADA members earlier this year. Dr. Rodriguez writes, “We are an Association of professionals in a field based on science and evidence…. ADA will not be distracted by engaging in point-by-point rebuttals of disparaging untruths and insults every time they appear on the Internet.”

Fine. We’ll do the point-by-point instead:

• Allegation: The ADA receives payments from Coca-Cola, Hershey, the National Dairy Council, Mars, PepsiCo, and others. Is this a lie? No: ADA lists them as corporate sponsors.
• Allegation: The credentialing arm of the ADA, the Commission on Dietetic Registration, offers continuing professional courses sponsored by Coca-Cola. Is this a lie? No: The Beverage Institute for Health & Wellness, which created the “Urban Myths” program, is an arm of the Coca-Cola Company.
• Allegation: The ADA allowed the junk food company–sponsored “Smart Choices” food labeling program (now considered a failure and an embarrassment) to be introduced at their Food & Nutrition Conference & Expo. Is this a lie? No: The New York Times reported on just how absurd the program was.
• Allegation: The ADA is under investigation by Congress. Is this a lie? No: Sen. Charles Grassley asked the ADA and other health advocacy groups for a listing of their payments from the pharmaceutical, medical device, and insurance industries. The senator’s investigation into the ADA’s financial transparency is ongoing.
• Allegation: The ADA receives about $1 million a year in payments from pharmaceutical companies. Is this a lie? No: Because of Sen. Grassley’s investigation, the ADA disclosed its payments from the pharmaceutical, medical device, and insurance industries.
• Allegation: The ADA allows pharmaceutical companies to market their controversial products at ADA events. Is this a lie? No: At the 2007 ADA Food & Nutrition Conference & Expo, GlaxoSmithKline was allowed to promote their first over-the-counter diet pill, Alli, even though the drug’s weight loss effectiveness is minimal and side effects such as hard-to-control bowel movements and anal discharge are common. The FDA has since issued warnings to Alli, noting the possibly of severe liver damage, and consumer groups are asking the FDA to remove Alli from the market.
• Allegation: The ADA is trying to gain a monopoly over nutritional therapy practice in the US. Is this a lie? No: The ADA has sponsored legislation in over 40 states that lumps dietitians and nutritionists into one licensing bill and requires nutritionists to complete its own dietitian program in order to practice nutritional therapy. Even if the nutritionist holds a Masters or a PhD in Nutrition, he or she is still required to complete registration through ADA just to continue to practice. In some states, these well-qualified individuals are even prohibited from using the words “nutritionist” and “nutritional care.”

Through Dr. Rodriguez’s letter, the ADA is even trying to suppress dialogue, critique, and discussion among its own members: “Sometimes, unfortunately, the re-posting of falsehoods is conducted (unintentionally, I am certain) by ADA members; I encourage all members…not to believe all that you read, and to make sure the information that you circulate is accurate.”

By contrast, our campaign is all about encouraging dialogue and discussion—among our members, among ADA members, with the media, and with the general public—and we are providing responsible RDs with the platform and voice that the ADA is denying them.

The ADA is deliberately avoiding an open conversation because our statements are not “disparaging untruths,” as Dr. Rodriguez calls them, but unassailable facts. They do not rebut our points because they have no legitimate defense. We would point out, however, that it is the ADA’s unprofessional, junk-food-and-pharmaceutical-industry-driven, monopolistic behavior that has spurred our campaign in the first place.

These are serious issues affecting consumers and nutrition professionals alike. They have a direct impact on the health of Americans and the cost of healthcare. They should be talked about, not censored. If the ADA believes we are spreading “untruths,” we invite them to prove it. Otherwise they are indicting themselves.

Please join our efforts by signing our petition at ReallyEatRight.org. Tell the ADA leadership to return the payments they receive from junk food and pharmaceutical companies, and end their attempts stop attempts to monopolize nutritional therapy through underhanded statewide legislative efforts! (If you’re a Registered Dietitian, nutrition student, or ADA member, please sign this one instead!)

FDA’s disastrous supplement guidance, which threatens thousands of supplements, would be greatly improved by a new bill in the House. But it isn’t enough.

Rep. Dan Burton (R-IN), a champion of health freedom who has repeatedly demonstrated a willingness to stand up for consumer choice about supplements, has introduced new legislation that would change the definition of New Dietary Ingredients (NDIs—that is, according to the FDA, new supplements).

Currently, all supplements containing new dietary ingredients introduced into the marketplace after Congress passed DSHEA in 1994 are considered NDIs by the FDA, and their manufacturers are required to notify the FDA when they are introduced. But, as we have reported extensively, FDA is attempting to contravene congressional intent by creating a pre-approval process modeled on what the pharmaceutical industry must go through before marketing its often lethal drugs, a change that could mean the loss of thousands of supplements.

To prove that a product is not an NDI, and thus exempt from these burdensome requirements, extensive evidence is required to show that the product was marketed before 1994. Rep. Burton’s bill would change that date to 2007. His creative approach would directly address one of the major difficulties with NDIs. Evidentiary documentation is much more accessible (especially with greater Internet data) for newer products than for products that are seventeen years old.

A good example is pyridoxamine, a natural and critically important form of vitamin B-6 which we discussed previously. Even though the ingredient was marketed before 1994, manufacturers could not provide sufficient documentation to prove it.

Unfortunately, Rep. Burton’s bill is not perfect. It doesn’t address a number key NDI concerns:

• FDA can still claim, without basis, that a grandfathered ingredient is “chemically altered”—and that would require a new NDI notification.
• FDA would not be stopped from moving its standard for NDI “notifications” closer to the food additive or pharmaceutical drug standard. This will continue to crush future innovation.
• FDA expects a different notification for the same ingredient for every different version of the supplement it is in. Contrary to Congress’s original intention—that each new dietary ingredient would provide notification—FDA seeks to apply their guidance to each supplement that contains an NDI. This means that a new magnesium formulation found in twenty different supplements would have to go through the expensive and burdensome process twenty times—once for each supplement.  Additionally, the same ingredient at a higher concentration would need a separate notification/approval.
• Worst of all, there is always the risk that this bill will give Congress the illusion that the NDI issue is being adequately addressed.

So we need further strengthening of this otherwise excellent bill.

Congress traditionally doesn’t like intervention in a regulatory process until it is complete. At this stage, FDA is still theoretically reviewing all of our comments and deciding what their final guidance will look like. Only after the FDA’s final guidance on NDI provisions can we analyze the best legislative solutions. But rest assured that we’ve been having in-depth strategy sessions for an approach that will comprehensively address the mess FDA is attempting to create with its NDI guidance.

Clearly FDA and Congress are listening to you! Rep. Burton and others are encouraged to take action by YOUR grassroots activism. But the clock is ticking—we only have a few weeks left before FDA shuts down the comment period! Now more than ever, we need you to keep up the great work and continue to send your messages on the NDI regulatory guidelines. If you have not already done so, please take action now!

You may have heard that the USDA awarded a hefty research grant to AquaBounty, the “Frankenfish” creator. But there is more to the story….

What you may not have heard is that the award came just as the company was facing major financial troubles. This was a bailout. And there are more GMO threats in our future coming to the produce area of our supermarket aisles.

In September, the US Department of Agriculture awarded $494,000 to AquaBounty to study technologies that would make their genetically engineered Atlantic salmon sterile, so it couldn’t mate with non-GMO salmon. AquaBounty’s current sterilization technology hasn’t proved 100% effective. On its face, the USDA grant was intended to remove one of environmentalists’ biggest objections to the GE salmon, marketed under the name AquAdvantage, although inter-species breeding is not the only known problem. The GE fish may also be significantly more allergenic than natural salmon among other issues.

It’s bad enough that government is in bed with industry and cannot possibly be objective in the review and approval process. But it is also noteworthy that the infusion of nearly half a million taxpayer dollars came just as AquaBounty was facing grave financial troubles. The company’s interim report shows a loss of $2.8 million in the first half of 2011 alone, and stated it was “considering options for raising further working capital.” Just a few months later, the USDA obliged by giving the company a nice, fat grant.

USDA’s sister agency, FDA, is still in its review process for the GE salmon. In its appropriations bill, the House voted to stop funding of the fish, but the Senate has not included the same language in its own appropriations bill. It seems a foregone conclusion that FDA will approve the salmon if USDA is funding it.

Representatives Don Young (AK) and Peter DeFazio (OR) sent a letter to the USDA asking them to rescind the grant. “The USDA should not be in the business of picking winners and losers,” said Young. “Propping up a company who has already researched and developed their technologies should not be the business of the federal government. This company is not losing money due to a lack of research; they are losing money because Americans prefer wild salmon over Frankenfish.”

Consumers also face a threat of unidentified genetically engineered foods in their produce aisle. Monsanto plans to dominate the $3 billion global produce market by making their GE seeds the primary source of the nation’s vegetables and fruits. According to Monsanto’s chief executive, “This isn’t a hobby….We’re serious about it.” As the Los Angeles Times put it,

Grocery customers in California and elsewhere are chopping its onions that produce fewer tears, stir-frying its broccoli that decreases cholesterol, and biting into tiny orange tomatoes that last longer on the shelf. Soon, people will be thumping melons bred to be a single serving and shucking sweet corn genetically modified to enable farmers to spray the fields with the company’s weed killer, Roundup. To do this, it’s marrying conventional breeding methods with its vast technological resources to bring about changes in fruits and vegetables in months or years, rather than in decades.

Currently, vegetable seeds represent only 8% of Monsanto’s revenue. However, the company has already acquired four vegetable seed companies, 57 research centers, and hired many researchers and scientists.

Citizens nationwide are demanding that genetically engineered foods and foods containing genetically modified organisms be clearly labeled as such. Send your message to the USDA, FDA, and Congress, and tell them how concerned you are about Monsanto’s push into our nation’s produce. Take action today!

Join ANH-USA and the Natural Health Alliance Foundation in a nationwide event to raise money for integrative medicine research—and to find real cures for breast cancer and other devastating diseases!

When the cure for breast cancer is often worse than the disease, continued access to important alternative treatments for breast cancer is more important than ever. We are asking YOU to help make that happen on Sunday, December 4.

It’s easy. Just go to the “Promote Integrative Medicine” event page and click the black button on the right that says, “Fundraise for this Event.” Choose whether you want to sign up as an individual, start a new team, or join an existing team. If you start a new team, you’ll be able to invite friends to join your team as well. If you wish, you can set a monetary goal for your fundraising event!

The main event page has a leaderboard showing which teams and individuals have raised the most money so far, so you can compete with others! Also check out ANH-USA staff’s team page, where you’ll find details of our own 10-mile hike in Washington, DC.

Washington metro area members and readers are welcome to join us on our hike! Just email [email protected] with the subject “Integrative Medicine Hike,” and we’ll send you details (including the hiking route) closer to the day of the event.

Registered Dietitians are tired of their organization being financed by the junk food industry and Big Pharma. Now they’re starting to speak out.

EatRight.org is the American Dietetic Association’s website. It claims to offer “food and nutrition information you can trust.” But can we really trust nutrition information from an organization that says sugar, fluoride, and artificial colors are safe for children?

We believe the ADA’s partnership with the junk food industry helps fuel the diabetes epidemic. If the ADA succeeds in its attempt to monopolize nutrition services, we will be left with nothing but a deep-fried and genetically modified junk-food-influenced nutrition profession.

In response, ANH-USA, Registered Dietitians, Certified Clinical Nutritionists, MDs, and concerned citizens have joined together to help launch ReallyEatRight.org to highlight how the ADA is working to undermine nutritionists—professional colleagues who also care passionately about health and food. We’re also trying to encourage the protection of nutrition services that can prevent chronic diseases like type 2 diabetes.

The site is filled with informative articles, including an internal ADA document that specifically discusses eliminating competition in the field of nutrition. The same document plainly states the rationale for the organization’s multi-state legislative effort to monopolize nutritional therapy: because “existing legal and regulatory constraints on practice are unlikely to prevent robust, broad competition” in the “growth area” of nutrition and dietetics. It discusses “significant competitive threats” from holistic nutritionists and naturopathic physicians, as well as nurses, pharmacists, chiropractors, and athletic trainers.

The practice of dietetics is one of the many different modalities of nutritional therapy. Many RDs feel that dietitians—and particularly their certification body, the Commission on Dietetic Registration—should respect and compete with other nutrition professions and licensing bodies in the marketplace, and should not subvert competition by creating a government-sanctioned monopoly through legislation.

In fact, growing numbers of Registered Dietitians, dietetic students, and ADA members are gravely concerned about the direction of the ADA and the negative impact that direction will have on its 70,000 members. They believe the ADA’s partnerships with junk food companies and the pharmaceutical industry—and the payments it continues to receive from them—have severely damaged the organization’s independence and credibility, and have severely compromised the professional legitimacy of dietitians.

ADA receives payments from soft drink giants Coca-Cola and Pepsi, industrial food monolith Aramark, cereal manufacturers General Mills and Kellogg’s, candy makers Hershey and Mars, and Unilever, the multinational corporation that owns many of the world’s consumer products brands in foods and beverages. It also receives funding from Abbott Nutrition, a division of pharmaceutical giant Abbott Laboratories (which makes Vicodin, a drug the FDA was advised in 2009 to take off the market because of overdoses and liver damage, and Meridia, the weight-loss drug which was withdrawn because it was both dangerous and ineffective). These are just some of the funders that are known.

“No group, especially one that receives payments from junk food companies, should monopolize the field of nutrition when there are many other healthcare professionals with advanced nutritional training. The ADA is creating a monopoly over the practice of nutritional therapy—to the detriment of consumer choice and our health,” said David Brownstein, MD, a board-certified family physician who uses nutritional therapies in his practice. “I’ve seen firsthand what the ADA considers ‘healthy food,’ and it is frightening to see their sugary and chemical-laden foods being given to people who are recovering from surgery,” said Dr. Brownstein.

RDs and consumers have good reason to be upset. Consider these facts:

• Lifestyle and nutrition is essential in preventing many chronic diseases such as type 2 diabetes, heart disease, and cancer—which currently place a huge burden on US healthcare. In the US, approximately ten percent of healthcare dollars are for diabetes treatment directly. Indirect costs are much higher and include increased work absenteeism, reduced productivity, and lost productive capacity due to early mortality.
• Instead of taking important preventive measures, healthcare is focused on treating the disease with drugs.
• Sen. Charles Grassley (R-IA) has asked the ADA and other health advocacy groups for a listing of their payments from the pharmaceutical, medical device, and insurance industries. The senator’s investigation is ongoing.
• The ADA receives about $1 million a year in payments from pharmaceutical companies. Because of Sen. Grassley’s investigation, the ADA disclosed their payments from the pharmaceutical, medical device, and insurance industries.
• The ADA receives payments from Coca-Cola, Hershey, the National Dairy Council, Mars, PepsiCo, and others. The ADA won’t say exactly how much they receive from these companies and industry associations.
• The credentialing arm of the ADA, the Commission on Dietetic Registration, offers continuing professional education courses sponsored by Coca-Cola.
• The ADA allowed the junk food company–sponsored “Smart Choices” food labeling program (now widely considered a failure and an embarrassment) to be introduced at their Food & Nutrition Conference & Expo. One of the biggest critics was Food Safety News (a very mainstream website, not particularly natural-health-friendly), whose reporter said, “The corporate takeover by Big Food was worse than I even imagined.”
• The ADA allows pharmaceutical companies to market their controversial products at ADA events. At the 2007 ADA Food & Nutrition Conference & Expo, GlaxoSmithKline was allowed to promote their first over-the-counter diet pill, Alli, even though the drug’s weight loss effectiveness is minimal and there are side effects such as hard-to-control bowel movements and anal discharge. The FDA has since issued warnings for Alli, noting the possibly of severe liver damage, and consumer groups are asking the FDA to remove Alli from the market.

You might be interested to know that come January, the American Dietetic Association is officially changing its name to the Academy of Nutrition and Dietetics. According to their press release, “The new name complements the focus of the organization to improve the nutritional well-being of the public.” We wonder if it’s not just a bit of whitewashing—or worse, an attempt to steal “nutrition” as a profession from Certified Nutritionists.

ReallyEatRight.org is designed to help RDs stand up and take back their profession from junk food companies, and to insist that their professional association start acting like a responsible partner in health instead of attempting to undermine their colleagues (nutritionists) through legislation. The site features Action Alerts designed specifically for Registered Dietitians and ADA members, as well as the general public. It currently has state-based initiatives for residents of New York and New Jersey!

It is our fervent hope that dietitians and nutritionists will be able to work together to improve the health of our citizens, without being weighed down by Big Pharma and junk food company interests. Our goal: To persuade 5,000 nutrition professionals and 25,000 citizens to sign the petitions, which we will deliver to the head of the ADA and request a response, with media documenting the event.

Please to go ReallyEatRight.org and sign the petitions today!

The senator’s latest volley has failed, but we can expect him to introduce something similar at the next opportunity.

Last month we told you about Sen. Dick Durbin’s stealth move against supplements—that he had proposed an amendment to an appropriations (budget) bill, which is a sneaky way of getting controversial laws passed without too much attention.

The amendment would have had the Government Accountability Office (GAO) assess the effectiveness and utility of the FDA’s adverse event reporting (AER) system, report to Congress on what actions FDA is taking to ensure that dietary supplement manufacturers are reporting adverse events, and also report on whether FDA has implemented the recommendations GAO made in its 2009 report on dietary supplements.

What’s especially sneaky about this is that the GAO’s report recommendations include increased supplement labeling regulations—one of the main goals of Sen. Durbin’s dangerous Dietary Supplement Labeling Act. It also recommends making a clear delineation between food and supplements—a first step toward treating supplements as drugs—another major feature of the Durbin bill.

The good news is that this sneaky amendment didn’t make it into the appropriations bill!

The bad news is that Durbin is both powerful and tenacious, and will almost certainly be introducing a bill or amendment that gets the same things accomplished some other way. We will, of course, continue to monitor the situation very carefully, so you can take appropriate action.

It’s an odd world when those that we entrust with our health—the medical establishment—are so resistant to supporting health in the way intended by nature.

Dr. Verkerk’s editorial follows:

Many who’ve yet to become fully aware of the extent of contemporary, western society’s disconnect with nature seem to take disconnection for granted. It’s almost as if this disconnected state is becoming the natural state in their minds. We are meant to accept that someone who exhibits symptoms of depression should be given Prozac, despite there being no evidence of any Prozac-deficiency, or any attempt to consider altering the circumstances or environment around the person.

Caesarean sections in some countries, like the UK, are now elective for any woman who so chooses. In a society where so many rights are being taken away from us, isn’t it a little puzzling that suddenly the rights of a woman who might want to avoid labor are now being granted? Could there be another motive—is it about scheduling of hospital births or is it about preempting lawsuits? Or could it be even more sinister?

The reality is that whether it’s the way we come into the world, the way we protect ourselves from diseases using vaccination, or the food available to us in supermarkets, most of it is darn right unnatural. Scientific evidence for the harm all this unnatural living causes us, in many cases, isn’t robust enough to force governments to recognize it (remember how long it took to force governments to recognize the harm caused by cigarette smoking?).

What we find instead is a different type of evidence. There is a growing troupe of us around the world, now likely to represent many millions—not just hundreds of thousands—who have understood this. We are choosing to live our lives differently, especially in how we eat, move or think, and it seems we’re not affected by the same rate of metabolic and psychiatric disease that afflict so many who choose to live off processed food from the supermarket or take a pill for every ill. Let’s face it, who can make money out of diet and lifestyle change? This is why one of our campaign strategies is of course not just to help people to adjust their lifestyles, but also to force governments to wake up to the cost of inappropriate diets and lifestyle, which are the main causes of the “Big 5” killer diseases: cancer, heart disease, diabetes, obesity and osteoporosis.

Central to our entire campaign for natural health are our efforts to raise awareness. While we provide a lot of material, you’ll understand that the real work in disseminating information far and wide is done by you—not us. Yes, in some areas it is vitally important to force change to bad pieces of legislation, such as those affecting herbal products in Europe, or to get some better sense into the science, another subject that’s very close to our hearts. But the greatest element of change comes from increasing awareness, so that individuals alter their understanding of what the established medical and scientific community tells them with regards their health. Ultimately it’s about us as individuals and social groups making permanent changes to our behavior. This is true self-empowerment, and you don’t even have to wait until tomorrow—you can do it today.

If you would like regular ANH-Europe updates, please sign up here.

Since he’s having trouble getting his own bill passed, he’s trying a different approach to get the same results. New Action Alert!

For weeks we have been telling you about Sen. Dick Durbin’s disastrous Dietary Supplement Labeling Act, which attempts to impose harsh limits on supplement availability by giving the FDA major new powers to make arbitrary standards and rules that will curtail supplement sales.

Initially it orders the FDA to compile, with help from the Institute of Medicine, a list of dietary ingredients (read: supplements) that could lead to adverse events or are otherwise deemed risky in some way. But creating lists of “bad” ingredients or “bad” doses based on completely arbitrary or non-existent standards is a slippery slope.

Now Sen. Durbin has proposed an amendment to an appropriations (budget) bill, which is a sneaky way of getting controversial laws passed without too much attention. The amendment would have the Government Accountability Office (GAO) assess the effectiveness and utility of the FDA’s adverse event reporting (AER) system, and report to Congress on what actions FDA is taking to ensure that dietary supplement manufacturers are reporting adverse events; how the AER system “informs the public” of FDA’s efforts to protect consumers; and, most especially, whether FDA has implemented the recommendations GAO made in its 2009 report on dietary supplements.

Buried in the GAO’s recommendations in its 2009 report are some of the same provisions that are also in Durbin’s unpopular Dietary Supplement Labeling Act. In our article on the report, we noted that the GAO recommended:

• increased supplement labeling regulations—one of the Durbin bill’s main goals;
• a clear delineation to be made between food and supplements—a first step toward treating supplements as drugs—this is also in the Durbin bill, and it’s the particular clause we feared he would slip into the appropriations bill; and
• an increase in AER requirements: currently only severe adverse events must be reported, but this would force AERs to be filed even for the most minor events.

The GAO undermined its own recommendation in the report by acknowledging that “FDA officials told us that the current regulatory framework is sufficient to identify and act on safety concerns regarding foods with added dietary ingredients.” This supports ANH-USA’s assertion that the FDA is already well equipped and needs no additional authority to do its job.

Furthermore, the number of supplement AERs is quite low—only 1,080 in 2008. And keep in mind that over half the US population (at least 154 million individuals) take nutritional supplements, according to data from 2007 National Health Interview Survey. The supplement AER figure is even lower when compared to the 526,527 prescription drug AERs in 2008. In other words, for every adverse event from supplements, there are 488 adverse events from prescription drugs!

Remember that it took the deaths of 55,000 Americans before FDA considered pulling Vioxx off the shelves.

The fact that Sen. Durbin has suggested this appropriations amendment indicates that he no longer has high hopes for the Durbin bill. Thanks to all the messages you’ve been sending Congress, he is having a difficult time gaining support for it—he has only been able to find one senator so far who is willing to co-sponsor his bill—and so he’s trying to pressure FDA into implementing the bill’s goals via the regulatory system. We believe it is also an attempt to lay stronger groundwork to push his bill through legislatively, once he gets the ball rolling and FDA starts to treat supplements more like drugs.

We should also note that Sen. Durbin was the architect of the current AER system, but he was unhappy with the political compromise that was struck when the law was passed originally—Sens. Hatch and Harkin agreed to a reporting system so long as it was only for severe events. Now we see Durbin pushing a requirement to have all adverse events be reported, no matter how minor.

What Sen. Durbin clearly wants is for every supplement to be approved by the FDA before it is sold. Everything he does is intended to move things in that direction.

There are fundamental objections to this. First, the FDA is biased in favor of drugs, probably because drugs pay the FDA’s bills. Since the agency sees supplements as competition for drugs, not many will be approved. Second, the agency will demand supplement trials just like drug trials—which is not appropriate for supplements. Supplements are like food: it is the combination and balance of what you take that matters, not just the effect of one pill. Third, the cost of complying with the pre-approval process will make supplements, already beyond many people’s budget, too expensive for all but the rich.

If this powerful senator can’t win using the direct approach, he’ll try an end-run. It may be politics as usual, but when it affects your family’s health, it’s time to fight back. We’ll keep you posted on the maneuvering around appropriations bills.

In the meantime, if you haven’t yet sent a message to Congress about the Durbin bill, please do it now! But just as important, the appropriations bill is scheduled to be voted on by next Monday, October 31, at which time Sen. Durbin will try to add his amendment. Please write your senators today and stop this language dead in its tracks!

Only 38 more days to tell FDA and Congress that the proposed rules for supplements could lead to the elimination of thousands of supplements and make the surviving ones much more expensive.

When FDA issued their draft guidance for New Dietary Ingredients (that is, supplements), the agency was perverting congressional intent—the congressmen who wrote the original legislation even told the FDA commissioner before the guidance was issued that it needed to be fully consistent with DSHEA! FDA was also attempting to circumvent the notification system Congress intended by instituting a scheme that mirrors the Waxman supplement pre-approval system, introduced in 1993, which DSHEA was intended to stop.

Here’s some important background for you.

Supplement and integrative medicine champion Sen. Orrin Hatch made this statement when he introduced the bill for DSHEA, the Dietary Supplement Health and Education Act of 1994:

In our free market society, consumers should be able to purchase dietary supplements and companies should be able to sell these products so long as the labeling and advertising are truthful, non-misleading, and there exists a reasonable scientific basis for product claims.

Unfortunately, not everyone in our federal government shares these views. For more than three decades, FDA has tried to restrict severely the ability of the dietary supplement industry to sell and market its products and, consequently, the ability of consumers to buy them. The agency has repeatedly attempted to impose unnecessarily stringent standards that would leave many if not most supplement companies with no practical choice but to close their doors.

In sharp contrast, Rep. Henry Waxman wanted dietary ingredients and nutritional supplements to be considered food additives and therefore subject to FDA approval—not unlike the system that is used for drugs. So Waxman introduced the Dietary Supplement Access and Claims Moratorium Act of 1993. This bill would have amended the food additive definition to include dietary ingredients (supplements)—thereby making supplements subject to the food additive approval process.

Happily, cooler heads in Congress prevailed. Sen. Hatch explicitly stated:

As you know, [DSHEA] makes clear that dietary supplements are not food additives or drugs, and that the burden of proof shall be on the FDA to prove that a product is unsafe.

Consequently, when DSHEA was passed, dietary ingredients were specifically exempted from the definition of “food additives,” making supplements not subject to FDA pre-approval. All that was needed was a simple notification.

Now FDA has offered its draft guidance—which attempts to circumvent DSHEA as it was passed and create a new pre-approval system. Everything about this proposal is a perversion of congressional intent, and will (as Sen. Hatch told the world eighteen years ago) severely restrict your ability to buy nutritional supplements and leave many—if not most—supplement companies with no practical choice but to close their doors.

Time is running out—the comment period ends on December 2! Help us protect your access to supplements. We need everyone reading this to send their message to Congress and FDA right now to make sure the FDA and Waxman don’t win! Take action today!

In a shocking move, the Centers for Disease Control and Prevention said today that the HPV vaccine Gardasil should be given to 11- to 12-year-old boys as well as girls.

The CDC’s Advisory Committee on Immunization Practices unanimously recommended routine vaccinations for boys to protect them from cancers related to the human papillomavirus, or HPV. Federal health officials usually adopt what the panel says and asks doctors and patients to follow the recommendations.

Merck & Co. designed Gardasil to prevent sexually transmitted HPV infections, which can lead to genital warts and cervical cancer in women, and cancer of the penis and anus in men. Merck won FDA approval for female patients in 2006, and male patients in 2009.

The problem, as we have pointed out previously, is that 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 cervical cancer is far from definitive.

According to Bloomberg.com, today’s finding reverses a 2009 recommendation by the panel that the HPV vaccine should be optional for boys. The panel at the time said the benefits of giving it routinely to 11- to 12- year-old boys wouldn’t justify the costs.

The CDC’s recommendation flies in the face of data from its own Vaccine Adverse Event Reporting System, which received a total of 18,727 reports of adverse events following Gardasil HPV vaccination. A whopping 1,498 of those events (8%) were considered “serious”—such as blood clots, the neurological disorder Guillain-Barre Syndrome, and 68 reports of death. While the most common reactions might be redness or swelling at the injection site, to ignore or soft-pedal the existence of serious side effects (including death!) is not acceptable.

As our readers know, the HPV vaccine has been a national issue recently thanks to the GOP presidential debates. During this time, the major media have faithfully parroted the line that the vaccine is safe, and have refused to pay any attention whatever to the adverse event reports or the testimony of parents. The US government’s Institute of Medicine has also chosen to ignore the adverse event reports, saying disingenuously that they only consider peer-reviewed research. Unfortunately, both the major media and many of the IOM researchers depend on the drug companies for support, and it appears that we cannot expect anyone in an official position even to acknowledge, much less investigate, reports—often submitted by doctors—of what this vaccine is really doing.

It is outrageous that this vaccine has been mandated for girls in some states. To recommend it for boys is no less outrageous.

Increasingly, breast cancer fundraising means playing ball with companies whose products actually cause cancer.

Susan G. Komen for the Cure, formerly known as the Susan G. Komen Breast Cancer Foundation, is the largest and most heavily funded breast cancer organization in the US. (Last year alone it took in about $420 million.)

Komen recently denied that BPA increases the risk of breast cancer, despite mounting evidence to the contrary! We wish we could say that we were surprised. But this is all too characteristic of the Komen modus operandi.

As you know, bisphenol A (BPA) is a common ingredient in polycarbonate plastics. It’s also a known hormone disruptor that has been linked with serious health problems: birth defects, heart disease—and breast cancer.

Why would Komen make such a reckless statement? One possible reason: their corporate sponsors are too heavily invested in products that contain BPA, though Komen denies the charge.

• Coca-Cola, which sponsors Komen grants, lines its soda cans with BPA. The company doesn’t deny it, either—but simply says “it’s not enough to hurt anyone.” In fact, research suggests that even tiny amounts of BPA will hurt you.
• General Mills uses BPA in its canned foods (bowing to consumer pressure on its Muir Glen canned tomatoes but keeping them in other canned foods), and Georgia-Pacific manufactures epoxy resins that contain BPA. Both are Komen corporate sponsors.

It’s called “pinkwashing”—claiming to care about breast cancer by promoting a pink ribbon product, while producing or selling other products that are linked to the disease.

Komen doesn’t just support big companies. It sells products itself. Komen’s “Promise Me” perfume line contains chemicals that are categorized as toxic and hazardous. Last month, Breast Cancer Action announced that independent laboratory testing conducted on their behalf discovered that the perfume contained galaxolide, a synthetic musk that works as a hormone disruptor and is detected in blood, breast milk, and even newborns; and toluene, a potent neurotoxicant that is banned by the International Fragrance Association (IFRA).

Of course, Komen also says that electromagnetic fields and organochloride pesticides like DDT do not increase cancer risk, and that to date no environmental pollutants that can increase breast cancer have been found. Only about 10 percent of cases of breast cancer in the US can be traced to hereditary factors, indicating that environment plays an important role—one that Komen chooses to ignore lest it upset its corporate sponsors.

Komen spends millions of dollars on finding “the cure,” yet promotes the corporate-driven medical mainstream status quo. This status quo includes oncologists getting rich by selling high priced chemo themselves, as well as annual mammograms which may do as much harm as good (the New York Times noted this week that “Pink Ribbon” campaigns and patient testimonials have imbued the mammogram with a kind of magic it doesn’t have)—while ignoring the contribution of integrative medicine, which focuses on prevention and root causes.

A recent Norwegian study found that mastectomy rates climb higher as more women have mammograms—that mammograms can lead to “cancer overdiagnosis” and potentially unnecessary invasive treatment. The study found that at best mammograms reduce the risk of dying from breast cancer by no more than 10 percent.

More disturbing is the fact that taking four films of each breast annually results in an exposure of approximately 1 rad (radiation-absorbed dose), which is about 1,000 times greater than that from a chest x-ray—which greatly raises the risk of breast cancer.

New data suggest that mammograms also increase the risk of false positives, and may miss up to a third or more of all breast cancers, depending on the type of cancer and the composition of the breast tissue.

Going against the Komen-led “pink” juggernaut can be difficult—California governor Jerry Brown questioned the efficacy of mammograms in the past and received a lot of negative backlash. But there are good alternative approaches to mammograms. Thermography and some forms of ultrasound are safer and may be more accurate when it comes to screening.

And much more can be done to prevent breast cancers, such as eating right, especially including some cruciferous vegetables; sleeping right, including the avoidance of blue lights at night; and taking fish oil, supplemental iodine, vitamin D, and selenium. And one should consider environmental factors, too. Cornell has a database on breast cancer and environmental risk factors.

Another vital preventive measure is controlling weight and blood sugar through exercise. The one thing we like about the Komen approach is their idea of getting out doors, even if it is to raise more money for Komen.

We thought we would offer an alternative: we would have our own fundraising event for integrative medicine research!

We are asking you to walk, run, hike, bike ride, or do some other physical activity—on Sunday, December 4. The event will support integrative medicine research and continued access to important alternative treatments for breast cancer. We’re asking our readers to organize some favorite physical activity, then get their friends to sponsor them through peer-to-peer fundraising .

The ANH-USA office will organize its own walk in Washington, DC, and DC-area members and readers welcome to join us! We’ll create our own fundraising page so folks can see our example.

Just go to the “Promote Integrative Medicine” event page and click the black button on the right that says, “Fundraise for this Event.” Choose whether you want to to sign up as an individual, start a new team, or join an existing team. If you start a new team, you’ll be able to invite friends to join your team as well. If you wish, you can even set a monetary goal for your fundraising event!

The main event page will have a leaderboard showing which teams and individuals have raised the most money so far, so you can compete with others!

ANH-USA staff’s team page will have details of our own 10-mile hike in Washington, DC. If you’d like to join them, email [email protected] with the subject “Integrative Medicine Hike,” and they’ll send you details (including the hiking route) closer to the day of the event. We will also be posting the details on the staff’s team page.

New info about last week’s horribly flawed vitamin study. This story keeps getting worse and worse. A new Action Alert!

Last Monday the Archives of Internal Medicine released a study claiming that vitamin use might lead to an earlier death. This set off a major media feeding frenzy, wave after wave of scary stories. Fox’s headline was typical: “Are Your Supplements Killing You?”

In our article last Tuesday, we pointed out that the study was “junk science” at its worst. The data were “observational”: women in Iowa were asked what supplements they were taking three times over eighteen years—that is every six years. Who remembers what they have taken over six years?

In addition, it was all anecdotal: you didn’t have to say what you were taking specifically, just vague terms like “multivitamin.” Were the vitamins synthetic or natural? How much did they take? Did they really take it, and for how long? Did they take it to stay healthy or because they had become very ill, perhaps with cancer? No one knows.

The next day, Dr. Robert Verkerk, our scientific director, weighed in. His analysis reveals, among many other interesting points, that all of the data was “adjusted” by the authors using methods of their own choice. If you look at the study itself, the first thing you see is an adjustment for “age and energy.” After this adjustment, vitamins C, B complex, E, D, as well as calcium, magnesium, selenium, and zinc all appear to add to years lived.

This evidently wasn’t an acceptable conclusion. So two more adjustments were made. First, if you had a healthy lifestyle and took vitamin C and lived longer, the longer life was attributed largely to the healthy lifestyle and not to the vitamin C. That put everything except B complex and calcium into neutral or negative territory.

Still the authors weren’t satisfied. They adjusted again, this time for healthy eating, with the result that every supplement except calcium, B complex, and vitamin D became a contributor to an earlier death, according to this undocumented and completely loony math, and only calcium actually lengthened life. Not surprisingly, almost none of this—except possibly for the the use of copper supplements taken by 24 women at the end of the study—could be claimed to be statistically significant, even using the authors’ own methods.

The only accurate conclusion that can be drawn from this data is that supplement users are generally healthier people. The why and how and whether it is meaningful is really unknown

The authors of the study admitted they started out with a hypothesis that supplements wouldn’t add to life. It appears, although it is not revealed, that the supplement users actually lived longer than the non-supplement users. But the authors just manipulated the data until they got what they wanted and more: Supplements not only didn’t help—they were killers! And the lazy, biased, or naïve major media took it from there.

Life Extension Foundation also did its own scientific analysis of the Archives of Internal Medicine study. Among other things, it pointed out that copper and iron are pro-oxidants, so their overuse should be expected to lead to earlier mortality. It also noted that many people start taking supplements only after they become ill, which is not controlled for in any way, and that a sizeable minority of the supplements users were also taking drugs that have since been proved to be highly dangerous—patented hormones in particular—although no attempt whatever was made to control for drug use.

To pretend to control for so many factors but not to control for drug use—and to get through peer review this way—is a sad commentary on the state of medical research today. Could this be related to the overwhelming influence of drug companies on medical research in general?

Mike Adams’ NaturalNews.com also offered a close analysis of the junk science. In addition to covering what it referred to as the study’s “statistical voodoo,” it also reminded us that the Archives of Internal Medicine “receives millions of dollars in advertising from drug companies,” part of the $400 million that goes from drug companies to medical journals, and that the major media trumpeting the study in scary headlines also stay afloat from the $4.7 billion spent in Pharma-to-consumer ads (all of this data is from 2008, and is actually higher now).

As Dr. David Brownstein noted in a video interview with Adams: “This study says absolutely nothing about vitamins. If this study was done in reverse, where vitamins were shown to be effective [easily accomplished with some further data manipulation], no journal would have printed [it] because it was so poorly done.”

It might also be worth mentioning that the results of this so-called study contradict another Archives of Internal Medicine study from 2009, with four times as many participants, which showed that vitamins neither helped nor hurt mortality. We have to point out, however, that the earlier study from the same journal was also junk science. The main difference between the two is that in 2009 the apparently biased authors thought they would generate controversy be saying that popular supplements didn’t help, while the clearly biased authors in 2011 took their screwy methodology right over the cliff.

After offering such shoddy work, the authors even had the temerity to advise people: “We recommend that [supplements only] be used with… symptomatic nutrient deficiency disease.” The problem is that, having set out to prove this point, the authors have only demeaned themselves with their methods.

Two other researchers, invited to comment by the journal, say that the study findings “add to the growing evidence demonstrating that certain anti-oxidant supplements, such as vitamin E, vitamin A, and beta carotene, can be harmful.” The trouble with this glib statement is that even the most “adjusted” data about these three supplements in the study is not statistically significant.

If you take a look at our web archive, you will see many articles about outrageous medical research studies and media distortions of even good studies. We can’t afford to let these pass by. At this very moment, the FDA is trying to revise the regulations governing supplements (see our Action Alert!) in a way that could raise supplement prices sky high and greatly restrict your choice. Senator Durbin has a bill in the Senate (see our Action Alert!) that would do the same. This phony Archives of Internal Medicine study will be used by the FDA and Durbin. It will fan the flames. We need to get the truth out there in response.

To do so, we have two new Action Alerts.

The first one is for doctors and scientists and will go to the editor of the Archives of Internal Medicine.

The second is for consumers, doctors, and scientists (note that we need doctors and scientists as well as consumers), and it will go to major media outlets—places like Bloomberg, AP, Reuters, NPR, Time, the New York Times, the Los Angeles Times, NBC, USA Today, the Daily Beast, and Fox, among others. It will also go to Congress because of the connection to new FDA regulations and the Durbin bill.

Please TAKE ACTION NOW!

Worry?—no. Supplements have a remarkable record of safety. Give it careful thought—yes. Here are some things to consider.

When planning a supplement regime, you should seek good professional advice. If you don’t already have a good professional advisor, a place to start would be physicians belonging to one of the organizations listed below. They generally use and are expert about supplements and integrative medicine in general:

• American Association of Environmental Medicine
• American Association of Naturopathic Physicians
• American College for the Advancement of Medicine
• International College of Integrative Medicine

In addition, there are some basic questions that you should ask yourself:

• Is this the right form of the supplement?
• Is it natural or synthetic?
• Are there co-factors that must be taken with it?
• Do I trust the company selling it?
• Am I taking the right amount?

Let’s take each of these in turn.

1. Is this the right form of the supplement, and is it natural or synthetic?

The sister publication of the Archives of Internal Medicine, the Journal of the American Medical Association, just released a study suggesting that vitamin E supplements increase prostate cancer risk for men. The results of the study are puzzling. Taking 400 IU of vitamin E seemed to increase risk; so did taking 200 mcg of selenium. But when men received both the vitamin E and the selenium together, the risk was about the same as taking nothing at all.

The real problem here, however, is the form of the vitamin, which was synthetic alpha-tocopherol. In our article last February, Jonathan Wright, MD, explained that nature does not give us isolated alpha-tocopherol. It gives us a mix of alpha-, beta-,delta-, and gamma tocopherols, and that too much alpha interferes with what seems to be the more important gamma form of the vitamin. In another article, our scientific director Rob Verkerk further explained that synthetic alpha-tocopherol is not a good substitute for the natural form, and that tocopherols in nature are always accompanied by the tocotrienols.

What is true for tocopherols is true for other vitamins. If we take extra beta-carotene, we should take other carotenes to balance it. If we take more of a B vitamin, we will probably need more of other B vitamins to balance it. This is one of the problems with trying to apply drug trial methods to supplements. It isn’t one supplement that helps or hurts us. It is achieving the right balance through food, supplements, and exercise.

The Archives of the Internal Medicine study covered elsewhere in this newsletter claimed that supplementing with copper might be particularly risky. This is probably correct, since copper acts as a pro-oxidant and too much of the metals can overwhelm our body’s natural ability to remove them. That said, there are times when a balanced approach means we need to take a copper supplement. For example, if we take a higher than normal dose of zinc at the onset of a viral infection, it may have to be balanced with copper.

The Archives of Internal Medicine article also argued that folic acid use might shorten life. Nothing can be concluded from this source because the study is such a flagrant example of junk science. But the question about folic acid safety is a real one, and also an urgent one since federal law requires folic acid fortification of some foods such as bread.

Fortunately there is good medical research on the subject, albeit still inconclusive. A study published in February is very suggestive that only folic acid, and not natural folates, may be a risk for cancer. Natural folates, even at high levels, help to prevent cancers. This echoes two studies in 2009, reported upon by our ANH-Europe colleagues, which suggest that high doses of synthetic folic acid may produce an unexpected rise in some cancers, while natural folates are best for lowering the risk of colorectal cancer.

The main point to be gleaned from the research is that there is a potentially important difference between the synthetic folic acid and the natural folate. While awaiting more evidence, a rational response might be to use folate rather than folic acid.

It is not quite that simple, however. Merck has a patent on one of the natural forms of folate, which drives up the price. How, you might ask, can a drug company patent a natural vitamin? Welcome to the wacky world of government regulation.

2. Are there co-factors which must be taken with your supplement?

The Archives of Internal Medicine study mentioned above concluded that calcium was the one supplement that might lengthen life. This does not agree with better research. A large problem is that calcium needs to be taken with co-factors, especially vitamins D3 and K2. If these co-factors are not present, the calcium may migrate to the heart or circulatory system rather than to the bones where it is needed. If calcium is taken without supplemental magnesium, there may be other problems. That is why in an article last year, we criticized the World Health Organization for proposing that isolated calcium be put into the water supply. To do so would be more junk science—and could potentially harm a lot of people.

3. Do I trust the company selling it and am I taking the right amount?

These are interrelated questions since the company will advise you on the amount to take. Once again, in addition to seeking professional advice, you should do some research on your own. Start with the supplement company’s website. Contact the company. Ask whether the material is natural or synthetic, where it gets its raw materials, and what sort of testing regime it has. Some supplement companies test everything very carefully. Some don’t. Insist on getting answers about this. Good companies will be proud of their testing and will want to tell you about it.

Unfortunately, better quality supplements can be more expensive. That is another reason why we need to keep the FDA from driving supplement prices even higher, right up to drug levels, by requiring a new pre-approval process (see our Action Alert).

How else can ANH-USA help you sort through this important question of supplement safety? Let us know your thoughts and concerns and we will try to get you the answers.

One more example of the rampant crony capitalism in food.

The judge who ruled that consumers have no right to consume milk from their own cows, and no right even to choose their own foods, has resigned his job so he can join one of Monsanto’s law firms.

Readers will recall that Dane County (Wisconsin) Circuit Court Judge Patrick J. Fiedler’s recent ruling against the property rights of cow owners and their right to consume raw milk from their own cows earned the first nomination for our new Tyranny of the Year Award.

Well, he is a judge no longer. He now works for the Axley Brynelson law firm, which defended Monsanto against a patent infringement case in early 2010. Here’s the interesting part: In that case, an Australian firm, GTL, sued Monsanto and several other companies for using its patented methods for analyzing DNA sequences. But even though it was a federal case, the district court that heard the matter sits in Dane County, Wisconsin, where Fiedler served as judge!

So here we have a judge ruling against pure, raw milk, which drives  consumers back to standard milk from cows fed antibiotics, growth hormones (sold—and genetically engineered—by Monsanto), and grain (from seed sold—and genetically engineered—by Monsanto). And then, immediately after his ruling, he goes to work for the law firm that defended Monsanto on a genetic engineering case.

We aren’t the least bit surprised. Are you?

…With more—and worse—drugs?

Mainstream medicine too frequently relies on pharmaceuticals to solve problems that FDA-approved medicines caused in the first place. Take, for example, delirium—a kind of mental confusion that’s a common complication of hospital admission, especially among people over 65. It is one of the biggest drains on the healthcare system, costing between $38 and $152 billion per year in the US alone. Patients who become delirious are more likely to die while hospitalized and in the months after leaving, and many suffer permanent loss of their mental faculties.

Worst of all, say researchers from Vanderbilt University, in many hospitals three-quarters of delirium cases go undiagnosed because patients are often quiet and withdrawn rather than agitated and hallucinating. As you will see, the undiagnosed patients may actually be better off.

Next month, Vanderbilt researchers will begin a study to see if giving antipsychotic drugs in an intensive care unit (ICU) can reduce delirium and subsequent cognitive decline.

Shockingly, the truth is that delirium is often triggered by medication given in hospital. Drugs that boost activity of the neurotransmitter dopamine, or block the effects of acetylcholine, increase the risk of delirium. Sedatives that are widely prescribed in an ICU and to patients undergoing surgery seem to be particularly risky in this respect.

Think about this: Even though one of the triggers of delirium is hospital-prescribed drugs (sedatives), the solution they’re considering is to prescribe even more dangerous and potentially damaging drugs (antipsychotics).

Side effects of the antipsychotic drugs which researchers hope will help with delirium include weight gain, type II diabetes, hyperlipidemia, inflammation of the heart muscle (myocarditis), sexual side effects, cataracts, and even more severe mental problems.

Why would trained researchers want to give delirium patients anti-psychotic medication? Are they delirious themselves? Or is this just more crony capitalism involving the corrupting effect of drug company money? It certainly won’t be hard to find drug company funding for this trial.

Integrative approaches can address the ICU delirium risk factors with less invasive common sense procedures. Keeping patients mobile, well-nourished, hydrated, and mentally active, giving them undisturbed sleep, and minimizing the use of mechanical ventilation have been shown to reduce the risk of delirium by 40%. It is hoped that providing individually tailored treatments, increasing physical therapy and problem-solving exercises, and avoiding certain drugs will further reduce that risk.

This problem—treating delirium with drugs likely to make the patient much worse, is not an isolated case. Drug treatments in general—even commonly prescribed medicines—often do more harm than good. For example, European researchers who tested more than 4,000 elderly people found that those who took an aspirin every day to reduce the risk of stroke were twice as likely to be diagnosed with late-stage age-related macular degeneration as those who did not. That is in addition to the risk of intestinal bleeding from this favorite drug.

Likewise, many common blood-pressure lowering drugs have serious side effects: ACE inhibitors lead to kidney failure, Beta-blockers can cause dizziness and impotence, and calcium channel blockers can increase risk of heart attack. Yet astonishingly, researchers recently recommended that blood-pressure lowering drugs be given to everyone, regardless of their actual blood pressure level!

We have written before about the risk of taking statins, the most widely prescribed drug in the world, for so-called high cholesterol. Even the entrenched medical dogma that HDL cholesterol is good and LDL is bad may not be right, or may at least be oversimplified. Scientists at Texas A&M University have found that LDL cholesterol is actually needed by the body to build new muscle—a finding that is particularly important for us as we get older and lose muscle more rapidly.

All of this illustrates why one-size-fits-all medicine, run or mandated by government and heavily influenced or controlled by corporate interests, will always lead to bad medicine. We need real competition in medicine, with many options available, so that new ideas and new research have a chance to be heard, and which patients and doctors have the right to choose.

Score one for environmentally conscious businesses. Keep up the pressure on your state legislatures—Take Action!

Remember the ludicrous lawsuit we told you about recently against ecological leader ChicoBag? The plaintiffs—Hilex Poly Company, Superbag Operating, and Advance Polybag, who make disposable single-use plastic bags—have dropped the case, most likely in response to public pressure from citizens like you!

Part of the lawsuit alleged that ChicoBag was spreading false information about plastic bags. When ChicoBag challenged the plastic bag companies to prove their allegations by publishing the true recycling rate of plastic bags, Superbag and Advance Polybag dropped out of the case. Hilex Poly, now fighting alone (one might say they were left “holding the bag”), quickly settled the case against ChicoBag.

The settlement brought some necessary changes. The plastic bag industry had been saying, “Bags don’t litter, people do.” But as part of the settlement, Hilex acknowledged that single-use bags can indeed become wind-blown litter even if they are properly disposed, and the company agreed to address the issue on its website and print a message on its bags telling users to tie the bag in a knot after using them to prevent windblown litter.

In addition, Hilex Poly had been saying that 12% of plastic bags are recycled, while ChicoBag, citing EPA figures, said only 1% of bags are recycled. Hilex Poly agreed to reassess their number to reflect the actual truth

A huge thank you goes out to our member activists for writing their legislators in support of plastic bag bills. Please continue writing and highlighting this important issue with our Action Alert—the tide of public opinion is definitely against the use of disposable plastic bags!

An exciting new ballot initiative, if California voters approve, could turn the tide against genetically engineered foods in America.

In 1994, a Monsanto employee was quoted as saying, “If you put a label on genetically engineered food you might as well put a skull and crossbones on it.” If that’s true, then a new ballot initiative in California—launched just last week—could mean the death knell for GMOs in America. Food manufacturers will not be able to afford different packaging and labeling for California customers only, so they’ll have to label all their food.

The Organic Consumers Association is asking California to require the labeling of GE foods as well as foods containing GE ingredients. To get the measure on the November 2012 ballot, they need to collect 504,760 signatures by March of next year.

As you know, ANH-USA strongly supports GE labeling and informed consumer choice, and this is a big step in the right direction. The public agrees: in a 2008 nationwide poll by Consumers Union, 95 percent of respondents said they thought food from genetically engineered animals should be labeled. And with consumers overwhelmingly against genetically engineered foods, a labeling requirement could remove these foods from the shelves.

We wish to thank Mike Adams for breaking this exciting news. We will keep readers informed as the initiative progresses.

If you live in California and want to help support this ballot initiative, please visit the Organic Consumers Fund campaign page to see how you can get involved.

Wisconsin judge goes further and rules that none of us—farmers or consumers—have the right to decide what we have for our own dinner. A state Action Alert!

Last week, Wisconsin judge Patrick J. Fiedler ruled against the property rights of cow owners and their right to consume raw milk from their own cows. Plaintiffs included Galyle Loiselle and Robert Karp, who boarded their cows at Mark and Petra Zinniker’s farm so that they could consume raw milk from them, and the Zinnikers. Here is what the judge said in his own words:

• Plaintiffs [Loiselle, Karp, and the Zinnikers] do not have a fundamental right to own and use a dairy cow or a dairy herd;
• Plaintiffs do not have a fundamental right to consume the milk from their own cow;
• Plaintiffs do not have a fundamental right to board their cow at the farm of a farmer; [and]
• Plaintiffs do not have a fundamental right to produce and consume the foods of their choice.

It would certainly seem that the judge’s ruling violates constitutional rights to property, private contract, and bodily autonomy. After all, is there a more fundamental right than deciding what to eat? (Before this, we thought the FDA’s contempt for freedom of food choice was bad enough!)

Accordingly, Dane County Circuit Court Judge Patrick J. Fiedler’s decision is hereby nominated for our new Tyranny of the Year Award. Every once in a while we’ll nominate a decision or action for the award, and at the end of the year we’ll ask our readers to vote for the one they think is the year’s biggest tyrannical act. (We thank our friend, Dr. Jonathan V. Wright of the renowned Tahoma Clinic in Washington, for suggesting the award. If you have a decision or action you’d like to nominate, please send us your suggestions!)

Raw milk is natural and healthful; people are 35,000 times more likely to get sick from other FDA-protected foods than from raw milk. One of our ANH staff members recalls milking his cow as a child and drinking the fresh milk. Let’s not allow that to become illegal.

If you are a Wisconsin resident, please write to your state legislators today and ask them to support Wisconsin bill SB 108, which allows for sale of unpasteurized milk and milk products.

ANH-USA is always working behind the scenes in Washington on your behalf. But sometimes we can’t shout it from the rooftops.

Last year we campaigned against Senator Leahy’s “food safety” bill that increased criminal penalties for “misbranding” or “adulterating” foods to a maximum of ten years in jail. It passed in the Senate but not the House. In April, we reported that the Leahy bill has been reintroduced in the current session of Congress, and we issued a new Action Alert.

What we couldn’t tell you last year was that under the original Leahy bill, nutritional supplement manufacturers and distributers were explicitly threatened with “misbranding” or “adulterating” jail terms if they failed to follow to the letter the FDA’s New Dietary Ingredient (in reality, new supplement) provisions.

Why couldn’t we tell you about it? Because we knew the FDA was busy crafting its NDI draft guidance at the time, and we didn’t want to say anything that might make the new guidance worse. For this reason, we worked behind the scenes, alongside other interested groups including the Natural Products Association, to get the explicit linkage to NDI removed from last year’s Leahy bill. If the NDI provision had remained and the law had been passed, then once the FDA’s draft guidance came out, FDA would have had even more power to seek ten-year jail sentences.

Risks are already high enough for new supplement producers without making them explicitly subject to a ten-year jail term for so-called “misbranding,” which in practice can mean a minor paperwork violation. If the government makes new supplement production too risky, then the inevitable result will be that we won’t have new supplements, and the drug companies will be cheering.

Because we collectively removed the explicit NDI provision from Leahy bill last year, the language wasn’t in the bill that was reintroduced this year. However, the Leahy bill is still a bad bill, one that is ripe for misuse. If passed, it is possible that someone might still try to apply the ten-year jail terms to the new supplement rules.

And supplements are not the only food in danger from the Leahy bill. For example, according to the FDA, raw milk producers are guilty of adulteration because raw milk is considered inherently unsafe—despite clear scientific evidence to the contrary! The Leahy bill would give the FDA a bigger hammer to go after raw milk providers. Speaking of raw milk, be sure to see our article in this issue on Wisconsin residents being denied the right to consume raw milk from their own cow!

The Leahy bill passed in the Senate and has been referred to the House Judiciary Committee and the House Energy and Commerce Committee. We will keep you posted.

They’re safe, effective, and backed by decades of solid research. So why has California made their sale illegal unless accompanied by a scary and verbose warning label? A state Action Alert!

Both pregnenolone and DHEA are naturally produced “parent” hormones to a variety of other hormones, including the sex hormones estrogen, progesterone, and testosterone, as well as hormones vital for controlling blood mineral content and metabolism. And both DHEA and pregnenolone have a number of startling benefits.

Pregnenolone aids in the development of new brain cells, produces significant improvements in both depression and schizophrenia, and shows promise in mitigating memory loss and even some of the abnormal structures in Alzheimer’s disease.

DHEA supplementation helps create improvements in muscle strength and bone mineral density, with a reduction in body fat mass, and there is substantial support for DHEA supplementation in adrenal insufficiency, hypopituitarism, osteoporosis, systemic lupus, depression, schizophrenia, and balancing the overproduction of cortisol produced by excessive stress. Too much cortisol ages us rapidly; a little extra DHEA can make all the difference.

Despite the overwhelmingly positive scientific research (last year alone, 380 new papers were published about DHEA), and despite their having been shown to be both safe and effective in decades of continued use by millions of people, California now mandates a warning on both DHEA and pregnenolone saying, in a lengthy text, that exceeding recommended serving may cause “serious adverse health effects” like rapid heartbeat, dizziness, blurred vision, or seizure. Such a warning will scare consumers away from these important supplements. No peer-reviewed studies have ever shown that DHEA or pregnenolone are associated with rapid heartbeat, dizziness, or blurred vision. No published studies have shown any risk of seizure from pregnenolone supplementation unless the patient already had a history of seizures.

Research on pregnenolone began in the 1930s. Studies in the 1940s showed that pregnenolone was effective on autoimmune disorders, including rheumatoid arthritis. But it was discarded when Merck’s newly introduced pharmaceutical agent, cortisone, was announced as a cure-all for rheumatoid arthritis in 1949. Sound familiar?

If you are a California resident, please contact your legislators and ask them to create an exemption for DHEA and pregnenolone in Section 110423(b) of the California Health and Safety Code.

If employed by Chicago, you’ll take whatever “preventive” medicine the city demands—or pay far more in insurance premiums!

Under Mayor Rahm Emanuel’s plan, unveiled last week, city employees must enroll in a conventional medicine–structured “wellness program” to manage chronic health problems such as obesity, diabetes, and high blood pressure. Employees who do not participate in the program will be required to pay an extra $50 per month in insurance premiums for each family member covered.

The Chicago program includes “enhanced screening and wellness training to establish benchmarks and long-term goals, including weight loss, medication, exercise, and kicking the smoking habit.” A form of this plan appears in the healthcare reform act as well—which should be no surprise, as Rahm Emanuel was one of its chief architects.

So imagine this picture. Conventional medical doctors tell you to take your blood pressure medication, whether you think it wise or not, whether you want to try natural alternatives or not. And if you don’t, you pay. Same for taking statins for high cholesterol, medications which many medical professionals agree are really dangerous to your health.

Preventive medicine is a hotly debated topic, as it should be. But for Rahm Emmanuel, it’s one-size-fits-all. You had better have your blood sugar at a specified level, or you will be required to take highly dangerous diabetes drugs. At least they won’t fire you or put you in jail if you don’t comply—it will just cost you money. So far.

This kind of incipient medical fascism is mainly a gift to Big Pharma, and we can be sure that Big Pharma is cheering Emmanuel on.

Who can we trust for accurate info?

Yale researchers working with Russian scientists have discovered a new tick-borne disease affecting thousands of Americans each year. It’s a bacterium called Borrelia miyamotoi, and it’s a distant relative of the spirochete that causes Lyme disease. It’s found in the same deer tick that transmits Lyme.

The new bacterium causes higher fevers than Lyme disease does, and the fevers often disappear and reappear after a week or two. It was actually discovered over a decade ago, though Dr. Durland Fish, the lead Yale researcher, was repeatedly refused a study grant from NIH until the Russian scientists proved it caused illness.

We are worried, frankly. If the NIH, the Centers for Disease Control, and the major media respond to this new illness as they did with Lyme disease, consumers have very little hope of receiving helpful, truthful information about how best to treat the disease if they become infected.

The New York Times article makes numerous incorrect statements about Lyme disease and its treatment—then says the new disease should probably be treated the same way. It says, for example, that two weeks of antibiotics “normally cures Lyme.” But many US and European studies demonstrate that short-course antibiotics actually fail to eradicate the Lyme spirochete—and result in up to a 40% relapse rate.

Moreover, mainstream medicine disagrees wildly on the best course of treatment; long-term IV antibiotics are recommended by many highly regarded authorities, though as we noted in February, chronic Lyme disease (CLD) is a systemic, debilitating condition that often persists despite antibiotic therapy. Integrative physicians are finding success with more holistic protocols.

The Times article then makes outrageously inflammatory statements such as “Most medical authorities, including the Centers for Disease Control and Prevention and the Infectious Disease Society of America, take the position that ‘chronic Lyme disease’ does not exist and that those victims either have other illnesses or are hypochondriacs. They oppose the solution demanded by some self-proclaimed victims: long-term intravenous antibiotics.”

Yes, the Infectious Disease Society of America believes chronic Lyme disease “does not exist.” But to say that “most medical authorities” agree is totally false. The International Lyme and Associated Diseases Society is filled with respected medical experts who say that chronic Lyme is a widespread, serious, and complex disease. To dismiss chronic Lyme suffers as merely “hypochondriacs” and “self-proclaimed victims” is not only offensive, it is unacceptably sloppy journalism.

The Times article quotes Dr. Fish talking about the difficulties in getting the study completed: “It’s been like pulling teeth. Go ask the NIH why.” But the reporter never went to NIH to ask the question. Was it just laziness on his part? Or is mainstream media so beholden to drug company advertisers and conventional medicine that no other view is considered?

If media reporting has been this untrustworthy with Lyme disease (which affects up to ten times as many people, though the statistics are unreliable and the real totals may be higher), how can it be relied upon with this new disease?

Unfortunately, we can’t trust the government’s Centers for Disease Control (CDC) either—the agency is ill-equipped to detect Lyme disease at all, much less chronic Lyme disease. Dr. Joseph Burrascano, who has treated the disease for over 30 years, says, “If you rely exclusively on the CDC diagnostic criteria, you’ll miss about 90% of cases, as very few patients fit the strict ‘classic’ profile defined by CDC.”

Nor can we trust the government’s National Institute of Health (NIH). It took them ten years to agree to study this new disease, and they are consistently behind cutting-edge medicine. For example, NIH refuses to study intravenous vitamin C, one of the most important adjunct treatments both for tick-borne diseases and for cancer.

If we’re to successfully tackle this new illness, we will need to rely on integrative physicians who understand and treat complex diseases with whole-body approaches. Treatment must be tailored to the individual. Dr. David Jernigan, a leading Lyme expert, has a fact-filled website on the treatment of Lyme disease and other tick-borne diseases. While we cannot recommend specific treatments, readers may wish to know what some respected integrative Lyme practitioners recommend:

• Frequently mentioned Lyme-specific protocols include hyperbaric oxygen therapy (but only if one does not have the co-infection Bartonella), intravenous vitamin C, samento (Cat’s Claw), colloidal silver, and artemisia. Some integrative doctors prescribe long-term antibiotics; if yours does, it is important to maintain a healthy GI tract with probiotics and digestive enzymes, as antibiotics wipe out the natural gut flora, which is an important part of the immune system.

• Another component of a whole body Lyme protocol is detoxification and building a strong immune system. Sweating, eating lots of cruciferous vegetables, taking dandelion, milk thistle, detoxifying herbal teas, chlorella, garlic, etc., are all excellent detox protocols. Diet: whole foods, fresh vegetables, and clean sources of protein. Maintain a low glycemic load: Lyme and co-infections like Candida thrive on sugar. Maintain high levels of nutrients: Lyme sufferers may be particularly deficient in magnesium and CoQ10.
• It is important to get daily exercise, to keep the lymph moving and increase body heat—Lyme seems to be sensitive to heat. Hot detox baths may also be helpful, and can speed healing. Dr. Jernigan recommends several specific baths in his book Beating Lyme Disease.

But major media continue their astonishing cover up of the government’s safety data on Merck’s vaccine. A new Action Alert!

On Thursday, Michele Bachmann once again attacked Rick Perry for his 2007 executive order mandating the HPV vaccine for all young girls in Texas—despite his attempts to dismiss serious medical concerns about the vaccine, as we reported last week.

At one point, Fox News journalist and debate host Chris Wallace told Bachmann that the American Academy of Pediatrics says the HPV vaccine has “an excellent safety record.” This is indeed what the AAP said in its recent press release.

We have discussed AAP’s ties to industry, among other failings, in earlier articles. The Academy’s claim about the HPV vaccine is demonstrably incorrect, but the organization is certainly in prominent company. The National Cancer Institute, a division of NIH, says on its website that “Thus far, no serious side effects have been shown to be caused by the vaccines.” The site also says, “A recent safety review by the FDA and the Centers for Disease Control and Prevention (CDC) considered adverse side effects related to Gardasil immunization that have been reported to the Vaccine Adverse Events Reporting System since the vaccine was licensed. The rates of adverse side effects in the safety review were consistent with what was seen in safety studies carried out before the vaccine was approved and were similar to those seen with other vaccines.”

The fact is, the CDC has received tens of thousands of adverse event reports after administration of the Gardasil HPV vaccine. Serious side effects like blood clots and Guillain-Barre Syndrome have been reported—as well as 68 reports of death from the vaccine. This is not “an excellent safety record” by any means—and if this is “similar to those [side effects] seen with other vaccines,” then vaccines are far more dangerous than anyone suspects.

Despite the potentially deadly side effects, the CDC is considering vaccinating boys for HPV as well. HPV also causes genital warts, and like many other viruses is widespread in the male population. According to Science Daily, one study showed that giving the vaccine to males could prevent as many as 90 percent of genital warts cases, although many wart viruses are not targeted by the vaccine, which casts doubt on the claim. Keep in mind also that the vaccine requires multiple shots to work.

What is in these shots? An excellent article in Natural News, citing SANE Vax and other sources, addressed this topic a few days ago. The HPV vaccine includes among its ingredients polysorbate 80 and sodium borate. Although polysorbate 80 is used as a food additive to increase the water solubility of oils, injection is quite different. According to the Polysorbate 80 Material Safety Data Sheet, it may be both carcinogenic and mutagenic. When injected into prepubescent rats, polysorbate 80 caused abnormal growth of reproductive organs and made the rats sterile. When used intravenously with vitamins it has caused anaphylactic shock. And polysorbate 80 is one of the ingredients in the swine flu vaccine as well.

Sodium borate (a salt of boric acid) is widely known as a roach pesticide. The US National Library of Medicine and NIH declared sodium borate to be a dangerous poison. Due to deaths from its use for disinfecting wounds and cleaning nurseries, its medical use has been discontinued. Side effects include: vomiting, diarrhea, skin rash, blisters, collapse, coma, convulsions, drowsiness, fever, low blood pressure, decreased urine output, sloughing of the skin, and twitching of facial muscles, arms, hands, legs, and feet.

The FDA’s review of the vaccine found that 73.3% participants in the Gardasil group experienced new medical conditions within fifteen days of receiving the HPV vaccination. The placebo group noted a similar percentage, because they were given the vaccine carrier solution (with the polysorbate 80 and the sodium borate) rather than the plain saline solution usually used in such trials.

If that weren’t enough, the vaccination safety organization SANE Vax discovered that Gardasil has been contaminated with HPV recombinant viral DNA (rDNA), a substance many government health and safety agencies classify as a biohazard. It was found in 100% of the thirteen samples tested, which had different lot numbers; the samples came from New Zealand, Australia, Spain, Poland, France, and three states in the US.

NaturalNews.com further reports that due to a lack of prescribing information furnished to doctors by Merck, doctors are reluctant to report adverse events and other factors; actual deaths and adverse events for Gardasil are hugely underreported. It has been estimated that only 10% of adverse events for other vaccines are reported, but with Gardasil the estimates range as low as 1%.

ANH-USA has been issuing corrections to Chris Wallace, the Huffington Post, the New York Times, CNN, and other media outlets that keep claiming that the HPV vaccine isn’t controversial and is in fact safe. So far none of these major media have acknowledged our correction or agreed even to acknowledge the government’s own extremely serious CDC adverse event data.

This is a total and complete cover up. Through our Action Alert, we invite you to add your voice to demand that major media at least acknowledge the existence of the very serious CDC adverse events safety data. Please take action now!

It’s supposed to help organic farmers. But it’s more likely to be just another sneaky way to help Monsanto. New Action Alert!

Last week, USDA secretary Tom Vilsack gave a clear directive to his department’s new Advisory Committee on Biotechnology and 21st Century Agriculture (AC21): come up with a plan to compensate organic and conventional farmers whose crops become contaminated because of genetically engineered foods.

This directive is clearly intended to sound like it will help farmers. But we think it is actually intended to help Monsanto. To see why we think this, a bit of background.

The committee is comprised of a broad spectrum of interested parties: organic scientists and organic trade organizations, conventional farming industry reps (including makers of high-fructose corn syrup), DuPont, agriculture experts, genetic engineering companies, lawyers, and a few concerned individuals.

As we reported recently, courts have increasingly been siding against GE and biotech farming when surrounding farms and products become contaminated. Bayer CropScience recently agreed to pay up to $750 million to farmers in the Midwest to settle lawsuits over its contamination of the US rice supply.

This is in sharp contrast to the past when Monsanto was suing nearby farmers whose crops were contaminated for theft of product and using the threat of suit to intimidate and silence.

Could this possibly mean, asks Marion Nestle in her Food Politics blog, that instead of Monsanto suing organic or conventional farmers whose crops get intermingled with patented GM varieties, Monsanto might now have to treat organic farmers fairly and pay them for the damage caused by the contamination? Or does the USDA actually have in mind a new protection scheme for Monsanto—a legal shelter that will limit Monsanto’s future monetary damages?

This isn’t the first time that our crony capitalist-inclined government has created a system protecting industry from liability. You may recall our stories on “vaccine courts” like the National Vaccine Injury Compensation Program, a no-fault system that compensates individuals harmed by vaccines. By denying the right to file lawsuits, it’s a way to protect the vaccine industry from potentially huge financial damages. Will this USDA compensation plan for GE crop contamination be just another gift to the biotech farming industry?

Tom Vilsack does not admit to being a crony of the biotech industry. The secretary was quoted as saying, “I have no favorite [type of agriculture] here,” but other statements—and past actions—make it clear that this is not a truthful statement. Today’s USDA acts virtually as an agent of Monsanto and other big GE companies. So do other government agencies which want to promote the export of this “American” product, as Wikileaks documents show.

Consumers, by contrast, have been voicing their objections to genetically engineered foods, and some elected officials are listening. In June, the House of Representatives amended the agriculture spending bill and prohibited the FDA from spending money to approve genetically engineered salmon. Sen. Lisa Murkowski (R-AK) recently said she would attempt to do the same for the Senate version of the bill.

ANH-USA strongly advocates for clear labeling on all genetically modified foods to give consumers an informed choice, a position which the American public strongly supports. Citizen activists have organized the Right2Know March—a massive sixteen-day march from New York City all the way to the White House to demand GMO labeling. The march takes place from October 1 to October 16; they are looking for walkers, bikers, drivers, volunteers, cheerleaders, hosts, and supporters, so be sure to visit their website for details.

Today please contact Congress and USDA secretary Tom Vilsack and tell them America will not stand for any USDA’s attempt to shield the GMO industry from liability when their products contaminate surrounding organic and conventional crops. Please take action now!

Do Perry and most of the media think they can get away with a complete cover up of the government’s own CDC data?

In the past few days, Governor Perry has tried to dismiss serious medical concerns over the HPV vaccine that he attempted to mandate in Texas. His strategy has been to keep the focus solely on rival GOP candidate Michele Bachmann’s story of a woman who claimed her daughter became mentally retarded after receiving the vaccine: “I think that was a statement that had no truth in it, no basis in fact.”

Perry intentionally ignored the shocking statistics about the HPV vaccine available at the CDC’s Vaccine Adverse Event Reporting System website. The Center received a total of 18,727 reports of adverse events following Gardasil HPV vaccination, with 1,498 of them (8%) considered “serious”—such as blood clots, the neurological disorder Guillain-Barre Syndrome, and 68 reports of death.

The fact that the data come from the government’s Center for Disease Control is particularly ironic, since the CDC’s former director, Dr. Julie Gerberding—who was essentially in charge of federal government decision-making about vaccines and disease-response programs—resigned in 2010 to become president of Merck Pharmaceuticals’ vaccine division. Merck is the maker of the HPV vaccine.

Perry isn’t the only party covering up the damning CDC data. Mainstream media and university spokespeople have also failed to do basic research on the HPV vaccine. In a recent Associated Press story, a reporter wrote, “Studies have found no serious side effects, with the most common reactions being redness or swelling at the injection site.” This is an incredible misstatement of fact, one which has not been corrected by the AP. And there have been other stories like it: the New York Times is saying the evidence shows the vaccine is safe—without mentioning the CDC at all.

Arthur Caplan, a bioethicist at the University of Pennsylvania, erroneously claimed that “The data show that the vaccine is safe and effective” and said that “It’s ethically obscene” to scare parents away from the vaccine. While the most common reactions might be redness or swelling at the injection site, to omit the existence of serious possible side effects (including death!) seems to us to be—well, “ethically obscene” is the phrase that comes to mind.

Vaccine Safety Isn’t the Only Area Where Perry Hasn’t Told the truth

This all took off at the September 12 Republican presidential candidate debate, when Michele Bachmann attacked Rick Perry for taking “thousands of dollars in political donations” from Merck, the global pharmaceutical and chemical company, and noted that the governor’s former chief of staff was the chief lobbyist for the drug company. She implied that those deep connections led to Perry’s executive order mandating human papillomavirus (HPV) vaccine be given to all pre-teen girls in Texas. Perry then said “It was [just] a $5,000 contribution that I had received from them.”

The truth is very different. Perry received tens of thousands of dollars from the Merck PAC during his tenure as governor (Bloomberg says “at least $23,500,” while the Washington Post says it was “nearly $30,000,” including $5,000 in 2006, one year before his HPV executive order). Merck also donated somewhere between $380,000 and $500,000 to the Republican Governors Association, which Perry chaired twice and which is a major Perry campaign contributor.

The executive order was issued when his chief of staff, Mike Toomey, was working for the Texas Lobby Group, which is retained by Merck. Merck paid Toomey as much as $535,000 in lobbying fees to promote Gardasil between 2005 and 2010. And where is Toomey today? He’s Perry’s “super PAC” coordinator.

Sarah Palin, commenting on the debate, called Perry’s involvement with Merck “crony capitalism.” Of course, she doesn’t seem to realize that this is just the tip of the iceberg when it comes to vaccine crony capitalism, as we pointed out recently. With many lucrative drug patents expiring, pushing vaccines is a good way for Big Pharma to restore their profits.

Ron Paul slammed Perry for the executive order in the September 7 debate, calling it “not good medicine…not good social policy,” and objected to the mandate being done through executive order despite protests from the Texas legislature—who voted overwhelmingly to repeal the order.

The bottom line here: Governor Perry isn’t telling the truth either about the safety record of the HPV vaccine or about the money he has received from Merck.

The HPV vaccine is not the only issue which ties Governor Perry to special interests and “dirty deals” in medicine.

Another scandal involves the Texas State Medical Board. Many people have wondered why the TMB has been able to harass integrative doctors so aggressively and in such an underhanded way. This too involves Perry quite directly.

Last year we reported on the allegations against the Texas State Medical Board from the Association of American Physicians and Surgeons. The AAPS charged the board with manipulation through anonymous complaints; conflicts of interest; violations of due process; breaches of privacy; and retaliation against those who speak out. We also reported on the board’s attacks on Dr. Bill Rea, a leading researcher and clinician in the field of environmental medicine and chemical sensitivity.

It was Governor Perry who made each and every appointment to the current Texas Medical Board, even reappointing six of them after the scandal broke.

In 2007, Perry reappointed Roberta Kalufut to the board, even though she was specifically charged in the AAPS lawsuit as follows: “[Kalufut] arranged for her husband to file anonymous complaints against other physicians, including her competitors in Abilene [and] worked inside the TMB, with other defendants, to discipline doctors based on anonymous complaints filed by her physician husband.” Kalufut resigned in 2008.

It might seem that ANH-USA is piling onto Perry. But we aren’t political partisans—we have no involvement in the GOP nomination process nor are we endorsing anybody. What we are concerned about is crony capitalism in medicine, which underlies the present medical system and leads to so many bad outcomes, including the legal suppression of integrative therapies, along with exorbitant costs, needless suffering, and unnecessary death.

It is clear to us that Gov. Perry is part of this problem, and voters need to understand that he doesn’t extend his professed small government stance to medicine. Indeed, his overall small government persona seems to be masking a bloated, big government approach to healthcare—one tightly allied with special interests.

It’s the latest in a series of the candidate’s bills supporting health freedom and our access to natural health remedies. A new Action Alert!

The Testimonial Free Speech Act, HR 2908, is a brief bill that would allow the dissemination of testimonials “containing a consumer’s actual perception of the mitigative, preventive, or curative properties of any food or dietary supplement based on the consumer’s experience with that food or dietary supplement.”

To some extent, the bill addresses the FDA’s contention that only drugs can show real benefit—because, by the agency’s definition, only drugs can cure, mitigate, or treat disease. Any mention of the therapeutic benefits of supplements, whether through personal testimonials, citied scientific literature, etc., is automatically considered “misbranding.”

We applaud Ron Paul for this bill, and for some other closely related free speech in healthcare/health freedom bills he has introduced in the current Congress:

• HR 2044, the Health Freedom Act: Prohibits FDA from preventing a disease claim unless it is “false and misleading in a material respect.” Amends the FD&C Act to say, “A food or dietary supplement for which a claim is made…is not a drug solely because of such claim.”
• HR 2045, the Freedom of Health Speech Act: Increases the burden of proof required by the FTC to prove false advertising cases against dietary supplement manufacturers. Excerpted scientific studies will not be considered advertising.

There are many other important Paul bills as well. You may recall our recent Action Alert on HR 1830, Ron Paul’s bill to allow raw milk to be sold across state lines. There is a bill, HR 1101, to repeal the federal healthcare mandate. For a complete list of Paul bills, go here.

Ron Paul also has our sincere thanks for introducing the dangerous HVP vaccine mandate into the Republican presidential candidate debates. For more on this, see our story in this issue.

Action Alert! Please contact your congressional representative today and urge his or her support of Ron Paul’s free speech in healthcare bills.

Increasingly Pharma is funding the FDA. No wonder the agency seems to dance to their tune.

The Prescription Drug User Fee Act (PDUFA) authorizes the FDA to collect fees from companies, allegedly to fund and expedite the drug approval process, but really to pay the agency’s bills. Under this authority, pharmaceutical companies pay fees for certain new human drug applications, biologics applications, and supplements submitted to the agency for review—and the FDA’s review of an application cannot begin until the fee has been submitted.

The law was enacted in 1992, and Congress needs to renew it every ten years; the next deadline for renewal is September 2012. To make this happen, the FDA has been performing its usual ritual of begging and blustering at the same time.

The FDA has been discussing a raise in the FDA “user” fees with industry since July 2010; in fact, Big Pharma had already agreed to a 6% increase in fees for new drugs through 2017. The increase is expected to produce an additional $40.4 million in user fee revenue in fiscal 2012, bringing the fiscal 2013 total to $712.8 million. But FDA still hasn’t arrived at a deal with companies on user fees for medical devices—the FDA made a proposal, but industry rejected it, so the negotiations continue.

According to the FDA itself, drug companies provide fully 60% of the FDA’s drug review costs—which means that the FDA’s review and regulation of pharmaceutical drugs is largely funded by the very drug companies under review!

Could this brand of crony capitalism be part of the reason why the FDA is apparently so biased against supplements, which it regards as competition for drugs? Or why the drugs the FDA approves are so dangerous that, as we reported last year, they kill 50,000 Americans and send more than 700,000 more to emergency rooms each year?

PDUFA is what is known as a “must-pass” bill. Such bills become vehicles for other, smaller bills looking to slide through unnoticed as riders. We will keep a close watch on that—as well as on the FDA’s so-called negotiations with its friends in the pharmaceutical industry.

Part Two of our recent article on the laws threatening integrative doctors and integrative medicine—one of our most popular articles last month!

(If you’d like to read Part One, our discussion of the legal problems threatening physicians who use integrative medicine, click here.)

Federal Law for Sellers of Food, Supplements, and Medical Devices

The Federal Food, Drug, and Cosmetic Act (FD&C) gives authority to the FDA to regulate interstate commerce of supplements, drugs, and devices. According to the FD&C, by definition, only drugs can claim to cure, prevent, mitigate, or treat a disease [section 201(g)]. Nothing else may make that claim—certainly not a food or supplement.

To legally market a drug (that is, any substance that can claim to cure, prevent, mitigate, or treat a disease), it must go through the lengthy and expensive FDA drug approval process. Any violation—that is, any sale of a “drug” that is not FDA-approved—can lead to seizure of the product, injunctions against its sale and distribution, and criminal penalties, including imprisonment, for the manufacturer.

And as we have noted many times before, if a substance is natural, it is not patentable, and companies can only recoup their huge investment (as much as a billion on average, although estimates vary) in FDA approval if they can make it up through the high prices that patent protection makes possible. Therefore, natural products in supplement form will never be able to claim to treat disease, including cancer [section 201(ff)].

Why Only Patentable Drugs Are Considered “Safe”

The FDA’s control over patients’ access to cancer drugs was challenged in a 1979 lawsuit, United States v. Rutherford. Terminally ill cancer patients sued to stop the FDA from preventing the interstate shipment and sale of Laetrile—a modified form of amygdalin, a naturally occurring substance found in apricot pits as well as in other plants. The Supreme Court determined that the FD&C “makes no express exceptions for drugs used by the terminally ill…Exceptions to clearly delineated statutes will be implied only where essential to prevent ‘absurd results’ or consequences obviously at variance with the policy of the enactment as a whole.”

The Court supported FDA’s position that terminally ill cancer patients must be ensured therapeutic gain, which is only “guaranteed” by FDA approval. What this means in effect is that only non-natural and therefore patentable drugs which can be brought through the FDA process are “safe” enough to be used, even though natural remedies, which our bodies have evolved with, are generally safer or at least more predictable in their effects.

The further irony here, of course, is that the FDA has often approved drugs that are outrageously unsafe, causing so many deaths that they are subsequently pulled from the market and banned. The US National Poison Data System’s latest report records only a single death concurrent with supplement use—an “unknown dietary supplement or homeopathic agent”—with no deaths reported before 2009. On the other hand, it shows that, of all products to which we are exposed that might cause harm, pharmaceutical drugs caused 80% of fatalities—with 122 deaths attributed just to acetaminophen—an over-the-counter pain reliever sold under the brand name Tylenol.

Even though supplements cannot claim to prevent or treat disease, everyone knows that they may often be used for this purpose, either by consumers who have studied the scientific research, or by doctors themselves.

FTC Currently Violating the Law

The Federal Trade Commission code contains both a general prohibition of unfair or deceptive acts or practices affecting commerce [15 USC 45(s)] and a provision specifically prohibiting false or deceptive advertising of foods, drugs, devices, or cosmetics [15 USC 52]. In other words, the FTC has authority to stop false advertising of drugs and supplements as well as unconventional treatments it deems to be false medical cures—including cancer treatments.

Unfortunately, as we reported this past April, the FTC has recently created new and arbitrary requirements for ANY food or dietary supplement health-related claim—and is enforcing them—in direct violation of federal law. The FTC is now requiring two random-controlled human trials for any health-related claim—even so-called structure/function claims, which are permitted under the Dietary Supplement Health and Education Act of 1994 (DSHEA) without such trials. In response, ANH-USA and our co-plaintiffs, Durk Pearson and Sandy Shaw, filed a Petition for Rulemaking before the FTC. This petition, if denied, will lead to a litigation phase.

Often the FDA and the FTC work together to target supplement and food companies, which is precisely why the Free Speech About Science Act is so important. There are also federal criminal statutes that might affect the marketing and advertising of unconventional cancer treatments, like the wire fraud statute, which prohibits use of telephone, radio, or television to make “false representations for products and services,” and the federal smuggling statute.

Given all these legal risks, producers of natural food, supplements, and devices deserve our thanks.

A reader asks us to clarify.

In response to Part One of our article on laws threatening integrative physicians and integrative medicine, Chad wrote:

Your article explains the difficulties that doctors encounter when [prescribing] compounded drugs for their patients that have not been approved by the FDA. But it also implies (quoting federal law) that it is legal for doctors to do so. This runs counter to stories I have heard about what a doctor really can and cannot [do]. Would you please provide further clarification?

Thank you, Chad, for highlighting an important area of the law as applies to doctors’ ability to prescribe “unapproved” drugs. In our article, we noted the following:

Federal law clearly states that licensed physicians may “manufacture, prepare, propagate, compound, or process drugs solely for use in the course of their professional practice” [21 USC 360(g)]. Furthermore, the Federal Food, Drug, and Cosmetic Act (FD&C) cannot regulate the therapeutic practices themselves.

There are problems, however. While practitioners might have the theoretical right to manufacture their own drugs, from the practical point of view the FDA takes a very expansive view of its authority and jurisdiction. For example, the rule stated above has been narrowly defined in at least the area of cancer treatment to apply only to intrastate activities. A report from the congressional Office of Technology Assessment, “Unconventional Cancer Treatments,” outlines the law at that time: “It is legal for physicians to prescribe treatments they manufacture that are unapproved by FDA, but only in the State in which they manufacture the treatments. It is illegal to transport unapproved drugs across State lines and laws pertaining to good manufacturing practices apply to physicians as well as to commercial medical manufacturers.”

It gets worse. The FDA holds that an “interstate commerce” test must be applied to all steps in a product’s manufacture, packaging, and distribution. This means that if any ingredient—even one test tube—used in the compounding of an unapproved drug was purchased out of state, the FDA would in its view have jurisdiction, as they would if the final product were to travel across state lines.

This report may or may not reflect the FDA’s current position on prescribing unapproved drugs as it was published several years ago, and we simply won’t know the FDA’s current thinking until they officially weigh in again. Any doctor wondering about this must consult with his or her own legal counsel and try to make sense of what is really senseless.

This is unfortunately part of a much larger problem. The FDA has shown us historically that it acts as a law unto itself, acting as executive agency, legislator, and judge all in one, although clearly forbidden to do so by the Constitution. If you don’t like it, you can sue, but the FDA has an unlimited legal budget and you don’t. That is part of the agency’s scare tactics—if you oppose us, we will bankrupt you or, if possible, put you in jail.

The crony capitalism in vaccines just gets worse. And don’t expect any help from so-called small government candidate Gov. Rick Perry. A state-
based action alert!

The US Department of Health & Human Services (HHS) has unveiled a new roadmap for increased vaccination and immunization for the 21st century, the National Vaccine Plan or NVP. It calls for new vaccines, at a time when children already get far too many vaccinations, especially when given all at once and at too young an age.

Why are the vaccines piled on top of each other in one doctor visit? Because the medical establishment is afraid to ask parents to bring their children back over and over again. So for reasons of “compliance” and “convenience” the child’s immune system  is assaulted all at once.

As we have pointed out, HHS would have more credibility if the government had not entered the vaccine business itself as a partner of major drug companies. Much of the funding for new vaccine facilities as well as new vaccines  is coming from the government itself; the government then legally requires parents to “consume” more and more of these products for their children.

This is a bailout for the drug industry, which is  financially ailing at the moment. It is crony capitalism at its worst, and it directly affects the most vulnerable population of all, our children.

Just before the NVP was unveiled, the Institute of Medicine released its first comprehensive safety review of vaccines in seventeen years. This was not a coincidence, of course. Predictably, the IOM said that vaccines can cause “certain side effects,” but serious ones appear to be “very rare”—with no link to autism.

Conspicuously, the evidence provided by around 5,000 families who had submitted cases to the US vaccine court claiming their children had developed autism following exposure to the MMR vaccine was quietly disposed of, the report indicating that the MMR/autism link “favors rejection.”

The report also avoided dealing with the case of ten-year-old Bailey Banks, which in 2007 proved a link between his MMR vaccine, a seizure sixteen days later, the subsequent development of “Pervasive Developmental Disorder (Not Otherwise Specified)” which the court—fully aware of the potential financial consequences for the vaccine industry—decided  was not an autism spectrum disorder (ASD). The fact remains that anyone observing Bailey would, from the medical records given in the case,  be unable to distinguish Bailey’s symptoms from other kids who had been diagnosed with ASD. This was simply another cover-up.

Despite the claim that vaccines are “generally safe,” even the IOM found convincing evidence of fainting, fever-triggered seizures, anaphylactic shock, a rare form of brain inflammation, shingles, pneumonia, hepatitis, meningitis, or, in the case of the chicken pox vaccine, chicken pox! There is no mention in the report of mercury in the flu vaccines, even in children’s shots or nasal inoculations, or the evidence that some vaccines do more harm than good. All this  suggests that the report is just another example of whitewashing for pharmaceutical interests.

(Keep in mind that the IOM is the agency that Senator Durbin would like to do the risk assessment on supplements and mandate labels—despite drug company money flowing to some scientists relied on by IOM, not to mention their abysmal lack of knowledge about supplements.)

One of the New Vaccine Plan’s objectives is to increase routine vaccination coverage levels for adolescents. For example, they want girls to have received three doses of human papillomavirus vaccine (HPV) by age 13 to 15 as means of preventing cervical cancer. This sounds reasonable until you realize 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 cervical cancer is far from definitive.

On top of the shocking lack of proof of the vaccine’s effectiveness are the mounting number of reports of “adverse reactions” from it. Dr. Diane Harper, lead developer of Gardasil^®, one of the HPV vaccines, has stated that the HPV vaccine is associated with Guillain-Barré Syndrome, and has resulted in deaths. And she actually questions the effectiveness of the vaccine, and says, “Please push for full disclosure in consent forms so that parents and potential vaccinated persons can weigh the benefits and risks of the HPV vaccination from their own perspective.”

The HPV vaccine was approved by the FDA and was recommended by the CDC in 2006. In January of this year, the head of the CDC since 2006, Dr Julie Gerberding, resigned to become president of the Merck vaccine division, which makes Gardasil. In the meantime, legislators in at least 41 states and the District of Columbia have introduced legislation to require inoculation with, fund, or educate the public about HPV. Fortunately, many of the bills have not passed.

In 2007, Texas governor Rick Perry mandated the HPV vaccine by executive order—an unusual action from a presidential candidate who says he is against big government. It was noted at the time that he had received campaign support from drug interests.

When Perry more recently received spinal fusion and nerve decompression surgery to treat a recurring injury, he underwent an experimental injection of his own stem cells, a therapy that isn’t FDA approved, has mixed evidence of success, and can cost upwards of tens of thousands of dollars. Perry’s chief of staff said, “He feels [it] is certainly his right to determine the best course of treatment for him.” If so, why would he require HPV vaccines for young girls against their and their parents’ wishes? Does health freedom work for him but not others? Thankfully, Texas legislators passed a bill overriding the executive order, and Perry withheld his veto.

Unfortunately, Virginia now mandates the HPV vaccine for girls on or after their 11th birthday, and Washington, DC, mandates that all girls enrolling in 6th grade for the first time receive the HPV vaccine. Both jurisdictions have opt-out provisions, since HPV is not communicable in a school setting. Opt-out provisions are good, but they’re not enough. Many parents do not know their rights, are not educated about the relative dangers of the HPV or about the vaccine against it, or are scared or pressured into making their child take the vaccination anyway.

There is an HPV bill pending in New York. If you’re a New York resident, please contact your legislators immediately and stand up for parental freedom of choice in vaccines. People should be able to choose whether to vaccinate their children or not, and to make that choice on a case-by-case basis. New York’s bill, for example, doesn’t offer an option to opt out of just the HPV vaccine—you have to opt out of all vaccines through a philosophical exemption. This is especially galling to parents who feel that some vaccines are safe while others are dangerous, and would like to be selective in their choices.

In New York, AB 699 requires that all children born after January 1, 1996, be vaccinated against HPV (in addition to the already mandated vaccines against polio, mumps, measles, diphtheria, rubella, chicken pox, meningitis, pertussis, tetanus, pneumococcal disease, and hepatitis B). New York residents, take action now!

Would creating a new federal agency just for supplements make things better or worse?

In our recent article on Sen. Durbin’s bill and his credibility problem, we wrote, “Assuming that Sen. Durbin is sincere—and we assume he is, despite his misleading arguments—he should create a new federal agency to be in charge of supplements. That would at least begin to make possible sensible federal oversight of the supplement industry.”

Lone Voice responded:

“Whoa, back up! ANH, I agreed with every word you wrote, before this paragraph. But I have to react with raised eyebrows to the above statement. HUH? The Feds should create another agency to…“be in charge of supplements”?…Why on earth would another government entity be any more effective than the FDA?…What we need, ANH, is less regulation and not more of it. To play musical chairs is only to play one more game….

“Can you please explain your thinking to us in your above statement? This strikes me as being at odds with all that, up until this very moment, I have always perceived you to be. Thank you for your open-book response and for your clarification. Sometimes impressions can be wrong, and when they are, they need to be corrected. I will look forward to your posted response, here. Thank you for all that you do, I have been following (and forwarding) your articles, with keen interest and appreciation for your brave and ethical work.”

Dear Lone Voice,

Thanks for an excellent question. And also for your belief in us.

This is not actually the first time we have suggested moving supplements out of the FDA. Here is what we said in an earlier article: “[We need] to move supplements out of the drug agency and into their own agency under Health and Human Services. It doesn’t work for the supplement regulator (currently FDA) to be so beholden to drug companies, since drug companies are very afraid of supplement competition, despite the current government gag orders forbidding supplement makers from explaining their medical prevention and treatment uses.”

Here are some of our other readers’ responses to that idea:

Charlene: “Please move supplements out of the drug agency into their own….It doesn’t work for the supplement regulator to be so beholden to drug companies, since drug companies don’t like the competition. Thank you.”

md: “Removing FDA from having any control over supplements has been my dream for years. What can ANH-USA members do to help move this notion forward?”

Gmic: “Your suggestion to move oversight of supplements from the purview of the FDA to its own agency is fabulous. Thanks for battling on all of our behalf!”

But Kathy had a doubt:

“Are you sure supplements would be safe under [a new agency]?”

Kathy and Lone Star are right to have their doubts. But we still think it would be a good idea to move supplements out of FDA. Here is the main point for us: Big Pharma is currently paying for a large part of the FDA budget. FDA employees’ salaries are indirectly paid by drugs, and they know it. When FDA employees leave the agency, they often hope to be hired by drug companies at much higher salaries. FDA outside experts are commonly paid by drug companies. The FDA has even had the gall recently to announce that it would suspend the few remaining conflict-of-interest rules so that it could hire more experts paid by drug companies.

Drug companies are afraid of competition from supplements, which are so much cheaper, usually safer, and often more effective. They know the only thing that limits competition from supplements is FDA censorship of supplement advertising—in particular, the refusal to allow any reference to valid, documented scientific research if it relates to a disease. But it isn’t just the drug companies that fear supplement competition—so does the FDA, apparently, because the agency depends so completely on drugs for funding.

Under these circumstances, it would help to get supplements out of the FDA. Would it solve everything? No. Would it help? Yes. To be cynical, the employees of this new agency would only have their jobs because there is a supplement industry! If the FDA thinks it has an economic incentive to suppress or kill the supplement industry or to turn supplements into drugs, these employees would have the opposite incentive.

Of course, this could all go wrong. Drug interests could somehow get control of the new agency anyway. Or it could be filled with FDA-trained personnel who just can’t shake the old thinking. But it could hardly be worse than the status quo.

We hope that explains our thinking a bit. It would be nice if government employees could be expected to devote themselves to public service and to the best possible outcome for the public without any thought of their own economic future. In the real world, we can’t expect that. And getting supplements out of the FDA would at least be a step in the right direction.

We need to ask Congress to review the FDA’s absurd claims and carefully watch over the FDA’s draft NDI (supplement) guidance process. Please join us in this nationwide campaign!

Previously we announced a Call-In Lobbying Day for Thursday, September 8. We’re asking each of you—members, grassroots activists, readers, and friends—to set some time aside on September 8 to phone your senators and representatives and voice your opposition to the NDI (dietary supplement) guidance. Tell them why you’re upset over the NDI guidance, and ask them to direct the FDA to carefully review their draft guidance and hold hearings at the end of the review process unless the FDA amends the guidance to reflect DSHEA (and Congress’s) stated values and goals. The FDA is clearly overreaching its authority, and the logic of its arguments in the guidance is questionable at best. Congress has FDA oversight and needs to review the agency’s actions in creating this new guidance.

Just go to this page—it will give you talking points for your conversation with your legislators’ offices, and has an interactive feature to look up your senators’ and representative’s names and phone numbers just by typing in your ZIP code.

We recently submitted our comments to the FDA in response to the first of two requests from the FDA for information, outlining the immense burden created by the dietary supplement draft guidance. Other concerned parties submitted comments in this first round as well. FDA responded with some pretty ludicrous logic.

The agency claims it will take only 20 hours per NDI notification. This is an absurd claim, considering the extensive paperwork and safety studies they require in the new draft guidance. Furthermore, as we have mentioned many times before, FDA refuses to file (that is, approve) most of the NDI notifications that are submitted, claiming that the notifications are “incomplete” or “inadequate.” So even though FDA rejects the majority of applications because they are incomplete, they really expect a supplement company to take only 20 hours per notification?

In addition, the FDA expects only 55 new NDI notifications per year. This is after officials stated in the guidance that there are 55,600 dietary supplements on the market. Something is very wrong with their math! Experts predict as many as 125,000 notifications.

Moreover, the FDA has not accounted for any of the costs to hire the expert consultants, scientists, etc., who will be required to successfully draft the NDI notifications. And they seriously think this won’t add any significant burden to industry?

Of course the ultimate issue here isn’t the cost or burden on supplement producers. The NDI guidance is really the first step toward an FDA approval process that will change the law governing supplements—and in the long run both sharply reduce the number of supplements sold and sharply increase the cost of those surviving.

We need Congress’s involvement, oversight, and correction. Join your fellow Americans in phoning your legislators on September 8 and asking them to stand against the FDA’s new supplement guidance!

Maybe they’re so caught up in the system that they just can’t imagine the best remedies sometimes only cost pennies.

Late summer is when kids go back to school and start spending hours playing sports in hot, humid weather. This can easily lead to heat exhaustion, which may lead to throwing up but also sometimes fatal complications. Just this past month, two Georgia high school student football players died. The American Academy of Pediatrics is concerned. It has issued new guidelines to help schools avoid heat illnesses of all kinds.

The key recommendations are not to exercise too long or frequently and not to wear hot uniforms and pads too long. Another recommendation is to drink plenty of water. This is commonsense advice, but it neglects an important warning: to avoid ice water, which can trigger the throwing up.

The pediatricians also recommend sports drinks for their electrolytes and salt. Is this more common sense? Hardly! The chief cause of heat exhaustion isn’t water. We can usually tell if we need water. It is lack of salt. What athletes really need is to take some additional salt both before and sometimes during play.

So why don’t the pediatricians mention this? A little salt costs only pennies. Why recommend unhealthy sports drinks, which cost too much and are often loaded with sweeteners (like high fructose corn syrup) and artificial ingredients (like bromated vegetable oil and glycerol ester of wood rosin), when the real answer is right in the kitchen cabinet and costs so little?

It is a tragic fact that many schools and coaches say absolutely nothing to their students and athletes about the importance of salt. Many students think that extra salt is bad for you. It certainly isn’t if you are playing in the kind of hot weather that can lead to heat exhaustion. The pediatricians could have helped this situation but chose not to. Why not? Is it because sports drinks are a 2.1 billion industry?

This is not the first time that the American Academy of Pediatrics has seemed to some to be a marketing agent for Big Food interests, selling expensive and doubtful products. Last year it was criticized for teaming up with Nestlé to make a series of nutrition messages intended to combat childhood obesity. Nestlé, of course, is the manufacturer of foods like KitKat, Haagen-Dazs, Hot Pockets, Baby Ruth bars, and Gerber baby foods—which, ironically, have been charged with containing too much salt.

But junk food and sports drinks are the least of the pediatricians’ sins. Too much of their income comes from administering childhood vaccines at too early ages in too large doses, and often containing dangerous ingredients such as the mercury in flu shots. We are afraid the pediatrics profession needs to do a lot more than cutting the ties to Nestlé or Coca-Cola.

Recent court decisions may help. Plus, new research shows how dangerous Monsanto’s GMOs really are.

Natural organic crops need to be protected from potential contamination by synthetic, genetically engineered seeds—especially in the face of less government oversight of GMOs. Natural seeds face the same Catch-22 as supplements: they cannot be patented, whereas synthetic seeds (and drugs) can be—and are therefore huge profit centers for Big Agro and Big Pharma, not to mention the government agencies in bed with them. They also need protection from the increased use of pesticides used on GE crops, which are also carried by the winds.

Our colleagues at ANH International reported recently that two court cases in the US might be turning the tide in favor of organic farmers over GE crops:

• Last December, the California Court of Appeal found the Western Farm Service guilty of “negligence, trespass, and nuisance” against Jacobs Organic Farm and the Del Cabo Organic Cooperative. In 2006 Western Farm applied GE organophosphate (OP) pesticides to Brussels sprouts grown on land neighboring the organic farms. Winds carried these pesticides onto the organic produce and contaminated it—making it unsalable as organic. Even though Western Farm claimed to have taken precautions to avoid pesticide drift, it still happened—and fortunately the court found them guilty.
• Last month, after ten years of futile complaints to the Minnesota Department of Agriculture, the Minnesota Court of Appeals found the Paynesville Farmers Union Cooperative Oil Company guilty of negligence, trespass, and nuisance on Oluf and Debra Johnson’s organic farm. Once again the pesticides sprayed on the oil company’s farms spread to the Johnsons’ land.

One of the big problems with GE crops is that they are responsible for the greatly increased use of pesticides which can easily contaminate organic crops. Now organic farms have legal precedents to sue conventional farms (and those using GMOs) for pesticide contamination.

Assuming EPA continues to approve more and more synthetic herbicides, these precedents will be an important tool in our arsenal. EPA recently approved a new herbicide called Imprelis. It’s billed as “environmentally friendly” but it is the leading suspect in the death of thousands trees all across the country.

Speaking of environmentally unfriendly GMOs, NPR reported this week that a type of genetically modified corn from Monsanto, which was developed to be impervious to a specific type of worm, may actually be causing the bugs to adapt and turn into “superbugs,” making the corn vulnerable to the very worms it was engineered to resist. Researchers at Iowa State University found that farmers who grew the Monsanto corn three years in a row got infested with “super” corn rootworms—and the damage they do could begin to reduce corn yields and raise corn prices.

Why are some of your legislators refusing emails from you—and what are we doing about it?

What does it tell us when our elected officials seal themselves up in Washington and refuse to take emails from the people who elected them?

No, we’re not making this up. Nor is it just an isolated case here and there. A surprising number of senators and representatives refuse to listen to American citizens by making it extremely difficult for them to provide public comments. So much for the democratic process!

We believe citizens should have the right to quickly, simply, and easily contact Congress to make their voices and opinions heard. But certain legislators refuse to accept email messages submitted by third parties like ANH-USA or other nonprofit advocacy groups. Instead, they set up complicated web forms as a way to discourage comment.

Here are the offenders, in alphabetical order:

Rep. Joe Barton (R-TX, District 6)
Rep. Judy Biggert (R-IL, District 13)
Rep. Ken Calvert (R-CA, District 44)
Sen. Mike Crapo (R-ID)
Rep. Wally Herger (R-CA, District 2)
Rep. Darrell E. Issa (R-CA, District 49)
Rep. Walter B. Jones Jr. (R-NC, District 3)
Rep. Connie Mack IV (R-FL, District 14)
Rep. Kevin McCarthy, (R-CA, District 22)
Sen. Jerry Moran (R-KS)
Rep. Devin G. Nunes (R-CA, District 21)
Sen. James E. Risch (R-ID)
Sen. Pat Roberts (R-KS)
Rep. David Schweikert (R-AZ, District 5)
Rep. Pete Sessions (R-TX, District 32)
Sen. Richard C. Shelby (R-AL)

Sen. Mark Warner (D-VA) was on that list, but after we contacted him about the issue, he is now accepting our alerts. We thank him, and applaud his willingness to listen to his constituents.

In addition to the above elected officials, Regulations.gov, the website used by federal agencies to receive comments on proposed rules, guidance, etc., changed its interface last year to ensure that third-party organizations like ANH-USA could not supply comments from our members and readers. Every time our software company would fix the issue, Regulations.gov would change their interface again. After speaking with Regulations.gov directly, they admitted that they didn’t want to receive comments from third-party websites.

Readers, rest assured that we’ve been mailing in your comments so they’re received by the agencies—whether they like it or not!

Please phone your elected officials today and tell them to remove obstacles to democratic participation! Our Call-In Action Alert lets you look up your legislators’ phone numbers, and gives you guidelines and a script outline you can refer to when you call. Or, if you prefer, go to the legislator’s website and send in a message using their form. But don’t be surprised if it isn’t possible to send in any message you want. Some of the forms require that you comment on a specified list of topics—another barrier to free communication.

Even if your elected officials are not on the list, you can still participate. Please phone Regulations.gov at 1-877-378-5457 and tell them you want your voice to be heard! You can use the same Action Alert—you won’t need to adapt the talking points very much to tailor them for a government agency instead of a legislator’s office.

Refuse to be silenced!

It isn’t just the FDA that wants to censor science in America. Three major plastic bag manufacturers are suing eco-friendly ChicoBag simply for citing scientific facts and statistics. Strike back with our new Action Alert!

Plastic grocery bags are not biodegradable. They clog waterways, spoil the landscape, pollute the soil and water (and therefore us), and choke birds and marine mammals who mistake them for food. Once they end up in landfills, they may take 1,000 years or more to break down into ever smaller particles that continue to pollute the environment.

These are facts.

Three large plastic bag makers—Hilex Poly Company, LLC; Superbag Operating, LTD; and Advance Polybag, Inc. apparently don’t like these kind of facts and have filed a lawsuit in South Carolina. They are suing the ChicoBag Company, claiming that it has caused harm to their businesses.

ChicoBag is trying to help eliminate the unnecessary use of single-use paper and plastic bags. They have designed reusable bags that are durable, tasteful, and convenient: they are small enough to tote in a pocket and have features that allow them to be clipped anywhere.

The three single-use plastic bag manufacturers accuse ChicoBag of unfair advertising and unfair competition. What did ChicoBag do that was so wrong? The company merely cited the effects of plastic bags on the environment on its Learn the Facts web page:

• “A reusable bag needs only to be used eleven times to have a lower environmental impact than using eleven disposable bags.” Source: EPA
• “Only one percent of plastic bags are recycled.” Source: EPA
• “Somewhere between 500 billion and a trillion plastic bags are consumed worldwide each year.” Source: National Geographic

Note that none of these facts come from ChicoBag. The company is simply citing well-known information from reputable sources. The same information has been used in countless publications, news stories, and websites over many years; ChicoBag is one of the few organizations that actually provides documented sources for the facts they use. In other words, the plastic bag industry seems to be angry that ChicoBag quoted the Environmental Protection Agency and National Geographic and told the truth. (We see this kind of behavior all the time from the FDA but it’s less usual in commerce.)

The lawsuit was conveniently filed in South Carolina because that state has no so-called anti-SLAPP laws—laws that protect against lawsuits “intended to censor, intimidate and silence critics by burdening them with the cost of a legal defense until they abandon their criticism or opposition.” The plaintiffs are citing the Lanham Act, a piece of trademark legislation which says a company can sue over claims which merely point to their product in general.

The discovery process (where both sides trade pertinent information with each other) is currently underway, and a jury trial is scheduled for sometime in early 2012.

Andy Keller, the owner and president of ChicoBag, has posted a detailed timeline showing the history and tactics of the single-use plastic bag industry against eco-friendly alternatives.

Plasticbaglaws.org is an excellent resource for staying vigilant on the issue. They also have a listing of all federal, state, and local laws and pending legislation pertaining to plastic bags on their website.

We have seven different Action Alerts for residents of those states with pending legislation about single-use plastic bags. None of the bills ask for an out-and-out ban. Many place a fee on single-use disposable bags, and some require that the plastic bags meet certain environmental standards. Further, some of the bills require that retailers sell reusable bags at the check-out counter. Supporting these bills is a good way to stand up to the plastic bag industry and let them know we don’t like their predatory tactics of intimidation. We also have a general Action Alert for residents of the other 43 states to ask their state legislators to introduce similar bills. Please take action today!

Indiana • Maryland • Oregon • Pennsylvania • Vermont • Virginia • Washington •

All Other States

The FDA says all new supplements since 1994 must be approved, but this will result in only 55 new applications. Huh? Experts predict as many as 125,000, and sale of these supplements will be illegal while the FDA decides what to do with them all.

If you’re new to this issue, please read about the FDA’s new scheme here. And if you haven’t already done so, please contact Congress immediately and voice your opposition to it!

Our analysis was created in response to an FDA statement in the Federal Register which grossly underestimated the burden of the proposed new guidance. It was drafted by renowned constitutional law attorney Jonathan Emord, with economic analysis by Dr. Joanna Shepherd Bailey, Associate Professor of Law at Emory University. Here are some additional findings:

• The FDA’s new guidance can be expected to cause major disruption in the dietary supplement industry, forcing significant numbers of products off the market, losing over $1 billion in revenue, and forcing over 100,000 Americans to lose their jobs.
• Rather than the 20 employee hours the FDA says are needed to do an NDI submission, our analysis shows it will cost between 100 and 350 hours of employee time. This will place the total cost to prepare these supplement approval applications (“notifications”) at between $845 million and $6.1 billion in employee wages.
• Animal and human product safety studies will cost between $450,000 and $6.6 million per notification, for a total cost to industry of between $2 billion and $165 billion.
• Where will industry be expected to get this money except from price increases? Supplements are already expensive. Millions more Americans won’t be able to afford them—just what the FDA and the drug industry would seem to want. It is a one-two thrust: Fail to approve many supplements, then make the rest too expensive for the average consumer.
• The federal government will lose between $1.84 billion to $3.54 billion in federal tax revenues; state and local governments will lose between $1.64 billion and $3.07 billion in taxes.
• Natural health is a huge growth industry. It is an area in which America has a competitive advantage. It can save billions in medical costs. But the federal government in the form of the FDA seems to want to shut it down. It is up to us, citizens and consumers, to tell them no.

Save the Date!

We are organizing a Call-In Lobbying Day on Thursday, September 8. This will be a coordinated effort and we are asking each of you—members, grassroots activists, readers, and friends—to set some time aside on that day to phone your senators and representatives and voice your opposition to the NDI (dietary supplement) guidance. We will have full details for you soon, including contact information and clear talking points so you can make your phone calls with confidence.

A humane society director warns that dogs addicted to Prozac become unadoptable.

Shirley Moore, director of Save a Dog of Sudbury, Massachusetts, writes:

I’m not surprised that the pet-loving population is not warned about Prozac. I just took a call from a woman last week whose dog was biting the kids and of course, the dog was on Prozac and she was told nothing about the side effects. She wanted to turn the dog over to the humane society, but I had to tell her that we can’t take dogs who are on Prozac because you can’t get them off of it. It’s designed to keep you coming back for more, just like all the other pharmaceuticals foisted on the pet owners.

There is disagreement and dissent within the veterinary community over a number of such medications. The American Veterinary Medical Association’s annual convention in New Orleans, attended by more than 10,000 of the country’s leading vets, saw a heated debate about the doggie antidepressants Clomicalm and Reconcile, and Slentrol, the world’s first canine anti-obesity pill.

The veterinarian at Eli Lilly, the company that makes Reconcile, says, “Behavior modification by itself works. There’s not any question about that. But if you use behavior modification in conjunction with Reconcile, it works quicker and it works better.” Yet Eli Lilly’s own study showed that short-term side effects include lethargy, depression, and loss of appetite. Is that an example of “working better”?

As we pointed out in our article and Shirley Moore underlined, it is easy to start antidepressant medications. But as with any highly addictive substance, it can be difficult to impossible to get off them.

Now Fido can have the same violent and psychotic breaks from SSRIs as humans. Please support our new Citizen Petition to the FDA!

The FDA has approved a reformulated version of the much-prescribed SSRI (selective serotonin reuptake inhibitor) Prozac, but this one is just for dogs. Reconcile was created to treat canine separation anxiety. It is a once-daily, chewable, dog-treat-flavored drug that is supposed to be used “in conjunction with a behavior modification plan.”

Reconcile’s full product label, which by law includes complete safety information, does not contain the black box warning that is mandatory on the drug for humans. Of course, that black box notice merely warns of increased risk of suicidal thinking and behavior in children, adolescents, and young adults. The label doesn’t make any mention of the documented connection between antidepressants and violence towards others, nor the drug’s propensity for causing mania, or increased feelings of hostility or anxiety in humans. Withdrawal from SSRIs can be similarly dangerous, ranging from nausea to suicidal ideations.

Given the tremendous risk of humans having a psychotic break when they take Prozac, what are the risks associated with animal use? No one knows—certainly not the FDA, which approved it. What if the dogs turn inexplicably violent? What if the breed is naturally aggressive (which would include the very breeds most prone to canine separation disorder)—will the drug heighten the aggression?

ANH-USA is submitting a Citizen Petition to the FDA to ask that information be added to the black box warning label for humans about the increased risk of violence from SSRIs, and to create a similar black box warning label for Reconcile for dogs as well.

A recent high-profile article in the New York Review of Books (links: part 1 and part 2) discusses the symbiotic relationship between the pharmaceutical industry and psychiatrists to push antidepressants. Some of the revelations:

• Many psychiatric drugs were created first, and then psychological abnormalities were postulated to fit the drug (not the other way around as is usually the case).
• The evidence that these drugs actually work is decidedly mixed, especially in the long term. Pharmaceutical companies have to provide the FDA with two clinical trials to prove efficacy of the drugs—and usually these successful trials are widely published. However, they never publish—and never make public—all the trials that were outright failures.
• Many pharmaceutical companies have close links with both the FDA (as we have reported in these pages many times before) as well as the medical industry.

Antidepressants, whether for humans or for pets, is a massive industry. According to the CDC, antidepressants are now among the top three classes of human medications prescribed in the US.

In fact, antidepressants are being increasingly prescribed for people who have never been diagnosed with any actual psychiatric disorder, according to a new study published in the journal Health Affairs. Nearly three-quarters of prescriptions written for antidepressants in 2007 came from non-psychiatrists, up from 60 percent a decade earlier. The percentage of patients prescribed antidepressants without having been formally diagnosed with a mental health condition more than doubled during that period—up from 2.5 to more than 6 percent of visits to non-psychiatrist providers.

Sometimes the antidepressant is just one ingredient in a combination pill; the patient may never even know what he or she is getting. An example of this, which we recently criticized, was the proposed diet pill Contrave—a drug the FDA has at least temporarily rejected. How many people wanting to lose weight would know that they are getting onto a highly addictive antidepressant?

Pushing drugs on animals is driven by the same profit incentive that we see with humans. Americans will spend over $50.8 billion on pet products and services this year. It is the fastest growing retail segment in our economy. As the New York Times noted:

Surveys by the American Pet Products Manufacturers Association found that 77 percent of dog owners and 52 percent of cat owners gave their animals some sort of medication in 2006, both up at least 25 percentage points from 2004. Sales of drugs for pets recently surpassed those for farm animals. Eli Lilly created its “companion animal” division at the beginning of 2007 and over the next three years hopes to release several other drugs. Pfizer, whose companion animal revenues have grown 57 percent since 2003 to nearly $1 billion, hopes to develop medications for pain, cancer and behavioral issues.

The FDA has approved other drugs for dogs as well: Slentrol is the country’s first canine anti-obesity medication, and Anipryl treats cognitive dysfunction so that absentminded pets can remember the location of the supper bowl or doggie door.

There is also the burgeoning market of chemotherapy for dogs. But in our desperation to save our beloved companion animals’ lives, we may well forget how incredibly dangerous chemotherapy can be for humans; it often does more harm than good. It is surely no less toxic to animals.

When Medicare reduced reimbursements for oncologists in 2003, some physicians started giving their patients more expensive chemotherapy drugs. Keep in mind also that oncologists are not only permitted to prescribe specific chemotherapy drugs to their patients; they may then sell those same drugs to them—at a huge profit. Other doctors may not sell drugs, but oncologists can. Will chemo for dogs become a huge new profit center too—without making the dogs live longer or better in any way?

As Shirley Moore, director of Save a Dog of Sudbury, Massachusetts, told us, “I’m not surprised that the pet-loving population is not warned about Prozac. I just took a call from a woman last week whose dog was biting the kids and of course, the dog was on Prozac and she was told nothing about the side effects. She wanted to turn the dog over to the humane society, but I had to tell her that we can’t take dogs who are on Prozac because you can’t get them off of it. It’s designed to keep you coming back for more, just like all the other pharmaceuticals foisted on the pet owners.”

There is disagreement and dissent within the veterinary community over a number of such medications. The American Veterinary Medical Association’s annual convention in New Orleans, attended by more than 10,000 of the country’s leading vets, saw a heated debate about the doggie antidepressants Clomicalm and Reconcile, and Slentrol, the world’s first canine anti-obesity pill.

The veterinarian at Eli Lilly, the company that makes Reconcile, says, “Behavior modification by itself works. There’s not any question about that. But if you use behavior modification in conjunction with Reconcile, it works quicker and it works better.” Yet Eli Lilly’s own study showed that short-term side effects include lethargy, depression, and loss of appetite. Is that an example of “working better”?

It is easy to start antidepressant medications. But as with any highly addictive substance, it can be difficult to impossible to get off them.

Please write to the US Food and Drug Administration today in support of our Citizen Petition to put Black Box Warnings on all SSRI drugs—whether for humans or for dogs—that warn of the link between antidepressants and sudden violent behavior.

The Washington Times recently printed an opinion piece discussing the threat nutritional supplements are facing from the FDA and Sen. Durbin’s bill. The senator’s response makes one wonder if he has read his own bill. A follow-up to our Action Alert.

Durbin says he introduced the bill in response to “a product on the market now that is escaping regulation as an adulterated food by marketing itself as a ‘dietary supplement.’” This refers to the melatonin-laced brownies sold as Lazy Cakes we’ve been telling you about (melatonin is a natural hormone that puts us to sleep). But the FDA has in fact moved against Lazy Cakes and quite appropriately shut them down. The agency could have done this from the start. It always had the authority to do so, as Durbin surely knows. Why did it wait so long? Perhaps to support Durbin’s bill, or to avoid revealing how misleading the senator’s arguments are?

Note also that of the bill’s eight pages, only two sentences address food companies like the one that made Lazy Cakes. Almost all of the bill is aimed at nutritional supplements.

The senator’s credibility problem doesn’t stop there. He says that his bill is designed to stop “mislabeling products and making health claims that have no scientific basis” and “marketing supplements with impure or incorrectly identified ingredients.” If that’s the case, he would be pleased to know that all those things are already against the law! That’s right: everything he mentioned is already prohibited under current law. Of course, the senator knows that perfectly well.

Since the purpose of this bill is clearly not the one stated, what is the purpose? It would seem to be an attempt to move us one step closer to a full FDA approval system for supplements. That, of course, would just make supplements insanely expensive, like drugs, if you could get them at all. If supplements are not yanked from the market, or turned into drugs, the high prices would kill demand and drive supplement companies out of business. The drug industry would be waiting, ready to pick up the pieces and make their current monopoly position even tighter. That’s why our Action Alert is so important—if you haven’t already done so, please take action now!

Under Durbin’s bill, the FDA would not be the sole evaluator of supplements. It would be assisted by the government’s Institute of Medicine. Perhaps this is supposed to satisfy critics of the FDA. But it doesn’t make the proposal any better. This is the same Institute of Medicine whose recent reevaluation of vitamin D doses has been ridiculed by scientists actually expert about vitamin D. Even conventional medical societies such as the American Association of Clinical Endocrinologists criticized the Institute’s work.

Here’s an example of the IOM’s logic. It recommended 600 IU of D for a pregnant woman. It then said that the moment the baby is born, it should have 400 IU while the mother continues to need 600 IU. On the face of it, this makes no sense at all. The IOM committee was also apparently about to restate the safe upper intake level of D well above the previous 2,000 IU per day. Then just before publication and for no apparent reason—certainly no reason based on science—it reversed course and pulled a meager 4,000 IU out of thin air as the new upper limit. Scientists such as John Cannell, MD, who have really studied D, suggest that 4,000 IU would be a more reasonable recommended daily allowance, not an upper limit.

Don’t forget that the FDA in 1972 tried to ban any supplement dose higher than 400 IU unless taken under a doctor’s prescription. What both the FDA and the Institute of Medicine have in common is that both agencies know very little about supplements but are nevertheless deeply biased against them. In the FDA’s case, this may be because of all the fees that the agency gets from drug companies. Or because many of the agency’s outside panelists are paid by drug companies. In the IOM’s case, many of its experts of course also receive fees from drug companies. Yet these are the people whom Senator Durbin wants to give completely arbitrary power over supplements!

For example, under the senator’s bill, the FDA could require warnings on supplement labels of any length that would say anything the government wants, no matter how unreasonable. It would create lists of “bad” ingredients or “bad” dosages based on completely arbitrary or nonexistent standards. Whatever the FDA says would go. And once an ingredient or supplement is singled out for this treatment, there is no process to challenge the determination, not even if new or contradictory evidence comes to light. This is really bad legislation.

Assuming that Sen. Durbin is sincere—and we assume he is, despite his misleading arguments—he should create a new federal agency to be in charge of supplements. That would at least begin to make possible sensible federal oversight of the supplement industry.

Michelle Minton, who works at the prestigious Competitive Enterprise Institute, got it exactly right in her July 28 article, “The Coming War on Vitamins.” Sen. Durbin’s Dietary Supplement Labeling Act (S. 1310) is part of a one-two punch aimed at eventually pulling supplements into the current and completely dysfunctional drug approval regime.

The second part of this one-two punch is the equally insidious proposed FDA New Dietary Ingredient (NDI) guidance, which applies to supplements created after 1994. Was it a coincidence that the bill and the proposed new standards rolled out at the same moment? Was the idea that if one was shot down, the other might get through? We don’t know. We do know that the American people need to know what is actually in the bill and the guidance, both of which are cloaked in obscure bureaucratic legalese intended to mask their true purposes.

It is past time for a return to honesty and openness in American politics. Sen. Durbin could start by abandoning the falsehood that his bill has anything to do with tainted brownies that have already been removed from the market.

If you have not already done so, please write to your senators and representatives immediately and ask them to oppose Sen. Durbin’s Dietary Supplement Labeling Act. Please take action now!

A reader asks an important question about the laws threatening integrative doctors. We lay it all out.

We recently received this question from David J. Getoff, CCN, CTN, FAAIM, vice president of the Price-Pottenger Nutrition Foundation:

I continually hear physicians say (at conferences) that it is illegal for them to treat patients with natural means (diet and supplements), and that in California and other states, it is illegal to treat cancer other than with chemo, surgery, and radiation.

I have been unable to locate the regulations which prohibit this and if I am going to mention this in my lectures, I need to be able to cite the actual legal regulations.

Can you help me?

David, we’ll be in touch with you privately over the specific laws you might wish to cite in your lectures. But for this newsletter (and for our other readers), here’s an overview of why natural health doctors and producers are under constant legal threat.

Whether for reasons of conviction or crony capitalism, the government is heavily biased in favor of conventional medicine and against integrative or natural medicine. So laws often trample doctors’ natural right and their patients’ right to choose the healthcare options they prefer. Recent legislation introduced by Sen. Durbin and the FDA’s disastrous NDI draft guidance offer even more evidence of that—as if we didn’t already have enough!

If you have not done so already, please follow these links to our urgent Action Alerts on the Durbin bill and the NDI draft guidance. Your access to supplements could depend on doing so.

Federal Law for Doctors

Federal law clearly states that licensed physicians may “manufacture, prepare, propagate, compound, or process drugs solely for use in the course of their professional practice” [21 USC 360(g)]. Furthermore, the Federal Food, Drug, and Cosmetic Act (FD&C) cannot regulate the therapeutic practices themselves.

Despite this, the FDA has approached individual doctors and threatened them with legal action if they continue to prescribe or use anything other than an FDA-approved drug or a drug being investigated under FDA procedures. For example, doctors legally using bioidentical hormones made by a local compounding pharmacy in their practice have been been intimidated by FDA officials who send a letter or demand a visit. FDA employees may also demand to see the doctor’s books or patient records, none of which is proper. The doctor may also worry that the FDA is in contact with medical insurance companies or the state medical board.

How Medicare and Medicaid Have Criminalized Natural Medicine

The federal government has also gained more and more control over individual doctors by paying their bills through Medicare, Medicaid, the Veterans Administration, etc. Federal law makes fraudulent billing a felony that can land a doctor in jail. This sounds fair, until one realizes that the federal government may interpret a natural health treatment as a fraud simply because it is not conventional. In this way, medical care has become criminalized and any doctor who accepts a government payment may be facing a jail sentence.

This is further complicated by the fact that a doctor who contacts Medicare and asks if a treatment is acceptable under notoriously uncertain and unclear government rules may be given completely different answers by different Medicare employees. But whatever the answer given, that answer does not represent an acceptable legal defense. A doctor may therefore check with Medicare, proceed in good faith, and still be threatened with jail.

If You Want Easier Treatment from the Government, You’d Better Hire Their Friends

Doctors faced with jail may agree to consent decrees with the government that govern everything they do and require them to fill out unbelievably burdensome reports. In order to fill out these reports, they may also be required by current government employees to hire former government employees at very high fees to help them do this. This aspect of federal supervision has been likened to a racket, which it often is.

Doctors must also be careful not to talk among themselves about the low reimbursement rates they are receiving from government agencies or decide to drop out of Medicare together. This can result in a charge of price-fixing under the Antitrust Acts and also lead to draconian consent decrees or worse.

In 2010 we wrote about a case in which the US Department of Justice, together with the Idaho Attorney General, charged a group of Boise orthopedists with a criminal violation of the antitrust laws for discussing what to do about the very low fees offered by the State Workers Compensation Program. They were intimidated into signing a ten-year consent decree agreeing to accept the Idaho Industrial Commissions’ price controls. News accounts also suggest that the doctors were “persuaded” to hire a high priced lawyer who until recently worked for the same division of the Justice Department that was suing them.

Is it any wonder that doctors today increasingly live in fear—whether fear of lawyers, insurance companies, or the government—and many wonder why they ever chose this profession in the first place?

State Laws for Doctors—and Drugs

Few people realize that in Kentucky, doctors cannot discuss chelation therapy with their patients or else they are subject to revocation of their license. Indeed, almost all Kentucky physicians who use alternative therapies have been either forced out of state or forced to desist from using alternative therapies, especially chelation therapy, because it “departs from prevailing practice in the State of Kentucky.” In other states, pediatricians face the loss of their insurance reimbursements if they fail to vaccinate all their patients.

While federal law is supposed to regulate the marketing and advertising of non-conventional treatments in interstate commerce, state laws describe what may or may not be allowed within the states themselves. Many states have adopted the same language as the federal code, in whole or part, to govern intrastate commerce. For example, many states have nearly identical definitions for the adulteration and misbranding of drugs as the ones in the FD&C, definitions that have little or nothing to do with what the words “adulteration” or “misbranding” actually mean in plain English.

At least thirty states have passed laws pertaining specifically to cancer, and a few of them have provisions for regulating non-conventional cancer treatments. Cancer laws provide for a variety of activities, including organizing and providing resources to combat the disease, establishing registries and advisory boards, and assisting patients in paying for the treatment. Some laws specify that cancer can be treated by only certain categories of licensed health professionals. Others authorize that the state health agency must approve cancer treatments before they can be used within the state.

For example, the California Health and Safety Code specifically prohibits the sale, prescription, or administration of a drug, medicine, compound, or device to be used in the diagnosis, treatment, alleviation, or cure of cancer unless it has been approved by the FDA or by the California Department of Public Health.

State Medical Boards Largely Controlled by the AMA

The bias against complementary, alternative, or integrative medicine in state governments is strongly reinforced by professional organizations like the American Medical Association. The AMA, which represents only about 13% of US medical doctors (even the AMA claims only 26%, but up to half that number are residents and medical students, who get big discounts on membership and a free subscription to a journal when they join), also has a seeming stranglehold on the Federation of State Medical Boards, which in turn greatly influences the state medical boards themselves.

All of these forces in turn influence insurance reimbursement policies, in most cases denying any reimbursement for alternative treatments and therapies. But nonpayment is the least of an integrative doctor’s worries. Of greater concern is the likelihood that the insurance company will send a complaint to the state medical board, or encourage a patient to do so, in order to shut down a doctor and avoid any future payments along similar lines. For this reason, many integrative doctors refuse to accept third party insurance. Even that tactic doesn’t always work, because the patient may send the bill to the insurer anyway, and the insurer may retaliate even though the doctor is not seeking payment.

Happily, several states have enacted laws that specifically exempt certain unconventional treatments and medical practices from state regulation. New Jersey, for example, offered the following rationale for its provision legalizing the use of Laetrile in cancer treatment: “In a free society, people should be able to choose their own forms of treatment for disease as long as doing so does not expose them to harmful products. In other words, the safety of drugs needs to be assured by government but not necessarily the effectiveness of drugs.”

A number of states have laws requiring informed consent, to give patients more responsibility over the therapies they choose.

State Laws Create and Enforce Monopolies which Drive Up Costs

Who can treat you is also determined by state laws. All state legal codes include medical practice acts which define the practice of medicine; stipulate the requirements for licensing health care practitioners; describe the conditions that can lead to disciplinary action; and provide for a medical board that is in charge of oversight.

Much of what doctors do could be done by highly trained nurses and other personnel, but the AMA in particular lobbies the legislatures to stop this sensible cost-saving reform. If federal legislation to insure the uninsured succeeded, everyone knows that there would not be enough doctors to service the demand, and prices would explode without such reform.

“Standard of Care” Means Whatever the State Medical Board Says

Many states do not have licensing options for naturopaths, homeopaths, acupuncturists, etc.—and so the legality of how and what they can practice is uncertain and varies. But MDs must be licensed before they may legally practice medicine in the US. And when their procedures fall outside what is generally considered “standard” medical practice (even when it is a higher standard of care), physicians who offer non-conventional treatments may become vulnerable to investigations for medical incompetence, or unprofessional behavior, or alleged violations of state or federal laws; a guilty verdict may result in fines, injunctions, loss of license, or even jail sentences.

This vulnerability is frequently heightened when the topic is cancer. Since the medical standard of care for cancer is chemotherapy and radiation, deviating from this standard can often be tricky, and state medical board attacks on integrative practitioners are all too common, and state medical board misbehavior is not uncommon. You may recall our article about the Texas Medical Board’s attack on a leading researcher and clinician in the field of environmental medicine and chemical sensitivity. Happily, the doctor still has his medical license (after three years in court), but it was a long battle.

Then there’s the all-too-typical case of Mark Geier, MD, a critic of using Thimerosal (a form of mercury) in vaccines, especially for children. His criticisms and revelations became a major thorn in the side of vaccine companies. In April of this year, he received a letter telling him that a secret hearing had been held by the Maryland Board of Physicians, and they had decided that he was “a danger to the public.” Because of that his license was being immediately suspended. At a hearing in May, neither Dr. Geier nor his attorney were allowed to examine any of the state’s witnesses (the state refuses to release their names), nor would they be allowed to produce any witnesses or testimony of their own. In fact, at no time before either of the hearings would the Maryland Board of Physicians tell Dr. Geier precisely what he had been accused of. The case is ongoing.

A key resource outlining state law is ANH-USA’s free 80-page report, “Know Your State’s Medical Board: An Integrative Medical Practitioner’s Guide to Understanding the Legal and Regulatory Environments in the 50 States.” Download it today!

Being a natural health physician is the highest legal risk profession we know. Because of this, we all owe a great debt of thanks to those brave physicians who persevere because of their love for medicine and genuine desire to help people.

Part Two coming in a future issue. We’ll continue this discussion with an overview of federal law as it pertains to sellers of food, supplements, and medical devices. Stay tuned!

Federal and state teams arrest people at gunpoint, destroy food, and seize assets—all because they’re afraid of unpasteurized milk and cheese. Please don’t let them trample the Constitution this way—a new Action Alert!

On August 2, there was an armed raid on Rawesome Foods in Venice, California, conducted jointly by the Los Angeles County Sheriff’s Office, the FDA, the Department of Agriculture, and the Centers for Disease Control and Prevention. You may recall that we reported about a similar FDA raid on the same co-op last year.

Mike Adams, editor of NaturalNews.com, broke the story last week, and we thank him for his excellent and continuing coverage of this issue. He reports that armed teams were deployed with guns drawn, law enforcement ordered all co-op members out of the store, seized all the cash in the register, then handcuffed the co-op’s founder, James Stewart, and placed him in an unmarked car without reading him hist rights.

Then authorities seized $70,000 in raw organic food—raw milk, cheese, yogurt, and fresh produce—and poured an estimated 800 gallons of milk down the drain, though there was no evidence that any of the products were contaminated.

Two others were arrested as well: Sharon Palmer, owner of Healthy Family Farms, and Victoria Bloch, the LA County liaison for the Weston A. Price Foundation. They were charged with the production and sale of unpasteurized goat milk, goat cheese, and other products without the proper permit; and with “mislabeling cheese.” They were also charged with four counts of conspiracy to commit a crime.

Unpasteurized dairy products are legal in California, but the Los Angeles District Attorney says that applicable licenses and permits are required. This is a specious claim. As Mike Adams points out, Rawesome does not need a license because it is not a public store, but rather a private club or co-op whose members actually own a percentage of the cows, goats, and farms that produce the raw dairy. The state of California is trying to regulate it as a public grocery store, when it is instead a private buyers’ club. The facility is used only as a distribution point for the products that the members already own.

All three of those arrested have been released from jail after posting bail, but only on condition that they give up their First Amendment rights and refrain from talking to anyone about the case—specifically, from communicating in any way, verbally or nonverbally, about the government raids conducted against them.

The public has responded with outrage. A public protest was held in front of the LA County Courthouse; this, together with the global attention the raid has caused, may have been responsible for the swift reduction in James Stewart’s bail—from $123,000 down to $30,000.

Bye-bye, Constitutional Rights?

The raid places a spotlight on the constitutional right of bodily autonomy. Do we have the right to decide what we eat? As the Supreme Court observed more than a century ago, “No right is held more sacred, or is more carefully guarded, by the common law, than the right of every individual to the possession and control of his own person, free from all restraint or interference of others, unless by clear and unquestionable authority of law.” And Justice Cardozo wrote in 1914, “Every human being of adult years and sound mind has a right to determine what shall be done with his own body.”

The FDA’s position is that people do not have the constitutional right to eat what they want. In response to a lawsuit by the Farm-to-Consumer Legal Defense (FCLD) Fund, the FDA made the following outrageous statements:

• “Plaintiffs’ assertion of a new ‘fundamental right’ to produce, obtain, and consume unpasteurized milk lacks any support in law.
• “There is no ‘deeply rooted’ historical tradition of unfettered access to foods of all kinds.”
• “Plaintiffs’ assertion of a ‘fundamental right to their own bodily and physical health, which includes what foods they do and do not choose to consume for themselves and their families,’ is similarly unavailing because plaintiffs do not have a fundamental right to obtain any food they wish.”

However, the US Constitution restricts the government from infringing on the rights of the people—so controlling what people eat, even through legislation, is an overreach of government power. In addition, it can be argued that health freedom—and the right to eat what we wish—is embedded in the ideas of privacy and personal autonomy protected by the 14th Amendment.

Government and Big Food

FDA justifies its actions from a food safety perspective. But virtually any food can contain harmful pathogens. In fact, you are 35,000 times more likely to get sick from other (FDA-protected) foods than you are from raw milk. Raw milk has been conclusively shown to be both safe and healthy.

The truth is, the FDA and other federal agencies are being motivated by the interests of Big Food—and in this case, the interests of the dairy industry. Once again, we see crony capitalism at work. The USDA has an entire marketing arm called Diary Management that actively pushes the sale of pasteurized cheese and milk.

This is merely the latest skirmish in the FDA’s long war against raw milk producers and small business owners. ANH-USA is working on a legislative approach that will buttress a right to health freedom, but for now, please read our new Action Alert. Congressman Ron Paul’s HR 1830 would authorize the interstate traffic of unpasteurized milk and milk products packaged for direct human consumption. Please contact your representative and senators today!

Want to let the drug industry take your favorite supplements off the market, patent them, and sell them back to you—by doctor’s prescription only—for 10 or 100 (or even more) times what you’re paying now? A follow-up to our recent Action Alert.

As Big Pharma becomes more desperate to boost flagging profits, the industry will likely use this tactic to find new sources of revenue—and shame on the FDA for so blatantly aiding and abetting it!

This coming year, seven of the world’s twenty bestselling drugs will lose their patent protection and can be sold in generic forms. On this list are the top two money-makers ever created: cholesterol fighting (but overall health-threatening) Lipitor and blood thinning (but bone-destroying) Plavix. This wave of expiring drugs patents will have unprecedented and devastating effects on the industry bottom line. One drug recently made available in generic form—Protonix, a medication for severe heartburn (again, not a drug we would use, and especially dangerous when used with the blood-thinner mentioned above)—previously cost about $170 per month when it was still under patent; its generic version now costs $16. With seven of the top-selling drugs expected to see similarly drastic drops in prices, the drug industry is in a panic—especially considering the fact that there are no new “blockbuster” drugs in the pharmaceutical industry pipeline. Under these circumstances, why not try to turn some supplements into drugs?

Even before the draft FDA’s NDI (new supplement) guidelines, supplement manufacturers already faced a “race-to-the-market” threat from the drug companies. The Dietary Supplement Health & Education Act of 1994 (DSHEA) states that a company cannot market a New Dietary Ingredient—that is, a new supplement—if an IND (Investigational New Drug) application for that ingredient has already been filed and research on that ingredient is publically available (a study published in any scientific journal will do).

If the ingredient was already used in a supplement legally marketed before the IND (drug) application was filed, then the supplement company can continue to market it even after the drug filing. But what does “legally marketed” mean to the FDA? It can mean that the supplement was sold in quantity before 1994. Or it can mean that the supplement’s NDI (new supplement) filing has been accepted by the FDA. The problem is that the FDA rejects most NDI (new supplement) filings. And it takes a long time to review even the few it accepts, giving drug companies plenty of time to get a competing drug application in. In complete disregard of the clear intent of the law governing supplements, the FDA has stacked the deck against any new supplement and in favor of any new drug.

Bottom line: If a drug company files an IND (drug) application for a natural substance before a supplement manufacturer can meet the onerous NDI (supplement) notification standards and receive FDA approval, the supplement company can never again sell the substance in its natural form.

This is precisely what happened to pyridoxamine, one of only three natural and bioavailable forms of vitamin B6. And it could also happen to P5P— the ultimate form of natural B6 which all other forms of B6 must convert to before being used by our body. Without P5P we would all die, yet the FDA may turn it into a prescription drug. Please see our Action Alert on P5P.

According to the FDA’s draft guidance, there are 55,600 dietary supplements on the market but only about 700 NDI applications (new supplement applications) have been sent, and the FDA has rejected around 64% of them. Not all of the 55,600 supplements are new (NDIs), but since an NDI is defined as any substance created, modified from its original form, or newly marketed any time in the past seventeen years, we can assume that many of them are! Depending on how the term new supplement is defined in practice by the FDA, there are many thousands of natural substances that can easily be turned into prescription drugs.

At the present time, it is not even possible to know how many IND (drug) applications for natural ingredients have already been filed by drug companies. All this information is kept under wraps by the FDA and not made publicly available.

ANH-USA has read several of the FDA rejected NDI notifications (applications) for very commonly used and essential natural substances—ingredients which are now being investigated as drugs. We don’t want to name them for fear that it would put a target on their back, but the problem is very real.

Wait, there’s more.

Any “new” supplement is already at risk of being converted into a drug—and this risk is greatly increased by the new FDA NDI (new supplement) guidelines. But the new FDA guidelines don’t stop there. While they encourage drug companies to take natural substances, they forbid supplement companies from selling synthetic botanicals.

What does this mean? “Botanicals” refers to plants. For years drug companies have studied plants for medicinal uses. If they find a useful plant, the next step is to try to create a synthetic analog of the natural plant substance, a new molecule that can be patented and then taken through the FDA as a new drug.

Nothing unfamiliar about this. What is new in the draft FDA NDI (new supplement) guidelines is that synthetic versions of botanicals may never be sold as supplements, only as drugs. In effect, the FDA is giving drug companies a monopoly on synthetics, knowing full well that, in general, only synthetics can be patented, and only patented substances can be brought through the hugely expensive FDA approval process.

This is all blatant crony capitalism—a huge gift to the drug industry without any conceivable benefit to the public. There can be no reason for it other than to pad Big Pharma’s pockets—a guaranteed monopoly on synthetic botanicals for drug companies to patent, all of which will lead to larger drug company fees being paid to the FDA.

In saying that drug companies should not have a monopoly on synthetic products, we are not endorsing synthetic products per se. At ANH, we prefer natural products. For one thing, they are generally safer. Why? Because synthetics are new to our bodies; we have not evolved with them. The risk of unintended or unknown side effects is greater. One of the oldest drugs in the world, aspirin, is a synthetic derivative of white willow bark. The herbal form is less likely to cause internal bleeding.

Cholesterol-lowering drugs like Lipitor, Zocor, and Pravachol are synthetics based on the natural ingredient ivostatin found in red yeast rice. The FDA has repeatedly gone after companies that sell red yeast rice products containing ivostatin, on the grounds that this entirely natural substance has now become “an approved drug product” which can only be sold as a drug. Lipitor is the currently the best-selling drug ever made, with 2010 global profits at about $11.7 billion. It is also, unlike red yeast rice, an unrecognized but major health risk for millions of users, as we have pointed out in earlier articles.

Lovaza (omega-3-acid ethyl esters), is the only FDA-approved semi-synthetic omega-3 fish oil, though a second drug, Epanova, is in Phase III of its drug trials. To keep the FDA approval cost down, it is supposedly only approved for the treatment of very high triglycerides. But doctors prescribe it for many reasons, and it is the only fish oil that Medicare and Medicaid and the Veterans Administration is allowed to reimburse. This is wonderfully profitable monopoly for the drug company producing it. Lovaza costs $6.75 per day, over $200 per month. A high-potency natural fish oil supplement with the same EPA and DHA amounts may cost less than 50¢ per day, or $15 per month.

Given a choice between natural and synthetic, we vote for natural. But that doesn’t mean that drug companies should have a monopoly on synthetics. If the FDA has its way, everything we take apart from food would be synthetic, patentable, sold by a drug company, prescribed by a doctor, cost a fortune, and produce a mountain of fees for the FDA itself.

If you have not done so already, please send your message to Congress through our Action Alert on the FDA’s NDI guidance. While you’re at it, be sure to see our Action Alert on the closely related and equally dangerous Durbin bill and let your voice be heard! We cannot emphasize strongly enough how very important it is that we fight on these two issues—your access to natural supplements is at stake!

Nearly 20 million Americans experience dire health problems from eating foods that contain gluten. Congress told FDA to define the term “gluten-free” for food manufacturers by 2008. Why are they still “studying the matter”? A new Action Alert!

Celiac disease is an autoimmune condition in which dietary gluten, causes damage to the small intestine, which keeps nutrients from being properly absorbed. Even small amounts of gluten in foods such as wheat, rye, barley, and other products, can lead to serious health problems, ranging from gastrointestinal distress and infertility to an increased risk of osteoporosis and certain cancers, particularly colon cancer.

As we reported recently, gluten-related conditions greatly increase the risk for diabetes. A recent large study published in the Journal of the American Medical Association found that people with diagnosed, undiagnosed, and “latent” celiac disease or gluten sensitivity had a higher risk of death, mostly from heart disease and cancer.

More than 2.3 million people in the US have celiac disease, or about 1 in 133 people; some estimates place the total as high as 3 million Americans—and growing.

Many more Americans—as many as 30–40% of the US population, according to the research of a leading US laboratory working in the field—have gluten sensitivity (also called Non-Celiac Gluten Intolerance), which means that they, too, are sickened by the protein. It is also sometimes referred to as “silent” celiac disease, as the disease may remain latent for twenty years or more before becoming full-blown celiac disease if gluten consumption is continued.

In these people, gluten continues to cause irritation to the lining of the intestine, often giving rise to poor digestion and malabsorption (as enzyme production is compromised), abdominal pain, irritability, achiness, sluggishness or fatigue, apathy, headaches, skin problems, depression, “foggy mind,” other decrease in brain function, or tingling extremities.

Dr. Mark Hyman reports that a review paper in The New England Journal of Medicine listed 55 “diseases” that can be caused by eating gluten. These include osteoporosis, irritable bowel disease, inflammatory bowel disease, anemia, cancer, fatigue, canker sores, rheumatoid arthritis, lupus, multiple sclerosis, and almost all other autoimmune diseases. Gluten is also linked to many psychiatric and neurological diseases, including anxiety, depression, schizophrenia, dementia, migraines, epilepsy, and neuropathy (nerve damage). It has also been linked to autism.

Two important factors that may create gluten sensitivity are a diet containing too much gluten, and increased permeability of the small intestinal lining, also called leaky gut syndrome—which, as we reported last week, may develop because genetically engineered food genes are transferring to our own genes.

The incidence of celiac disease is rising sharply—and not just due to greater awareness: the rate has increased fourfold in the last 50 years. One possible culprit: agricultural changes to wheat that have boosted and changed the amount and quality of proteins present.

Celiac disease is being diagnosed in people as old as 70 who have eaten gluten safely all their lives—most likely the result of adults losing their immunological tolerance for gluten as they get older.

The treatment to this massive, preventable health problem—a problem aggravated by the fact that gluten is ubiquitous in the Western diet and is abundant in wheat, one of our most-consumed foods—is straightforward: a commitment to a gluten-free diet. Not a low-gluten diet, but a diet that is more-or-less completely free of gluten (i.e., containing gluten at less than 20 parts per million, or ppm).

The high numbers of celiac sufferers, and the rise in people with gluten sensitivity, has food manufacturers looking at a lucrative new niche. The gluten-free market is projected to reach $2.6 billion next year, up from $100 million in 2003, with products carrying a premium price. But there’s a problem: while some products labeled gluten-free contain no gluten, others might have a trace, and still others could contain a sizable amount.

In 2004, Congress gave the FDA until 2008 to establish a uniform definition for companies that want to label their products as gluten-free. But that deadline came and went three years ago.

The Washington Post reports that the FDA has spent years calling on experts to have open-forum debates and town hall meetings—all of whom have been saying the same things about the dangers of gluten and what “gluten-free” should mean. As Alessio Fasano, medical director of the Center for Celiac Research at the University of Maryland School of Medicine, said recently, “I really don’t understand why it’s lingering up in the air when it really should be a no-brainer.”

The FDA has said the issue is complicated, requiring analyses of various technical issues, including how well manufacturers and regulators can reliably test for the presence of gluten and whether oats are a source of gluten (not usually, but they can be—see Note below).

An FDA spokesperson recently told the Washington Post that “efforts are now underway” to publish another document in the Federal Register and reopen the matter to another round of public comments. The FDA will then “consider the comments,” the findings of a safety assessment and “other factors” to develop a final rule.

In other words, the agency is deliberately dragging its feet.

Even the House Appropriations Committee, which is considering FDA funding, noted the agency’s failure to meet its deadline: “Public Law 108–282 required a final rule…not later than August 2008….The Committee instructs FDA to issue a final rule before December 31, 2011.”

Three years of flouting the law, and all FDA gets is a slap on the wrist.

Canada, Brazil, and Australia have all set labeling standards for gluten-free items. In most cases, that standard is 20 parts per million: A food can be labeled gluten-free if it contains less than 0.0007 of an ounce of gluten for every 2.2 pounds of food. That level was chosen largely because it’s the minimum amount of gluten that can be reliably detected.

These countries have developed this standard after many years of discussion on the subject at the Codex Alimentarius Commission. Before 2008, the Codex standard for “gluten-free” foods was a whopping 200 ppm. The US government delegation, comprised of FDA staff, agreed to the international guideline level being lowered to 20 ppm. Now they seem to have cold feet. Is it that gluten is so widely distributed in processed foods that US food corporations would struggle to cope with the 20 ppm level?

Meanwhile in North Carolina two weeks ago, a man was sentenced to eleven years in prison after he was found guilty of buying regular breads and rolls and repackaging them as gluten-free under the name Great Specialty Products. Dozens of people became ill as a result.

On May 4, concerned citizens brought the world’s largest gluten-free cake—“symbolizing the big deal that clear, accurate, reliable labeling plays in the lives of people dependent on labeling for their health”—to Capitol Hill in protest of FDA’s inaction.

Please write to the FDA immediately and tell them to stop listening to Big Food interests, and define “gluten-free” to mean gluten-free.

Update: On August 3, one day after this article was published, the FDA reopened comment on gluten-free labeling. All messages sent through our Action Alert will be redirected so that you can make your voice heard during this comment period.

Note:

Gluten is a naturally occurring group of proteins in cereal grains which makes bread dough elastic and chewy and gives pasta its structure. Besides being found in grains, it is very common in more-or-less all processed foods, including foods many consumers would imagine were gluten-free, from processed meats to ready-made meals, soy sauce, blue cheese, brown rice syrup, and what ingredients labels call “flavor enhancer.” It may also be found in everyday products such as medicines, vitamins, and lip balms.

Oats are naturally gluten-free, but cross-contamination is a major problem. If oats are grown in a field that previously grew other gluten-containing grains, some of those grains will naturally grow in the oat field the next year, and they will contaminate next year’s oats. Cross-contamination can also occur if the farmer uses the same equipment to process all his grains, or the transport company bringing the oats to the processor has stored and transported other grains, or if the processor processes other gluten-containing grains. The same problem occurs with corn chips and corn tortillas—there is a high level of gluten cross-contamination. For these reasons, celiacs and those people eating gluten-free should purchase only certified gluten-free oats and corn products.

Prof. Markku Mäki, head of a gluten research at the Academy of Finland’s Research Program on Nutrition, Food, and Health, has been at the forefront of gluten research worldwide for over three decades. He estimates that around 75% of people with gluten intolerance remain undiagnosed owing to mild or atypical symptoms. However, he argues that continued exposure can lead to full-blown celiac disease later in life, explaining the fact that typically around twice as many of people over age 50 have celiac disease as compared with their younger counterparts. His group has also shown that while gluten intolerance may be inherited by many, it may also be triggered by environmental factors, including exposure to particular viruses. Gluten intolerance is the most common genetic disorder in North America and Europe, although it is found in populations all over the world.

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Despite a lack of independent safety testing, the government has seen fit to declare there will be no oversight of a genetically engineered grass. Is this the beginning of a GE avalanche?

Just before the July 4th weekend, the USDA released a statement saying that the agency has no authority to regulate genetically engineered (GE) Kentucky bluegrass. This leaves Kentucky bluegrass completely unregulated—and sets the precedent for a complete lack of oversight of GE crops in the future. This is extremely worrying: there are very few independent studies investigating the safety of genetically modified organisms (GMOs), and the ones that have been published show that GMOs can have very dangerous long term effects.

Oversight of GE crops is extremely lax, because there is no federal law specific to their regulation. The USDA only has two provisions that apply to GMOs—the regulation of plant pests, and the noxious weed provision.

The Plant Pest Act—a law established in the 1950s—gives the USDA power to restrict the introduction of organisms that might harm plants. In a bit of a stretch, the USDA has used this power to regulate GE crops. The reasoning is that GE crops qualify as “plant pests” because historically the DNA from natural plant pathogens/microbial material (bacteria, fungi, etc.) was used in the genetic engineering of various plants.

However, this is increasingly no longer the case. Kentucky bluegrass, for example, doesn’t use the DNA from plant pests at all. Accordingly, the makers of Kentucky Bluegrass, Scotts Miracle-Gro, claims the USDA has no authority over them since “Kentucky bluegrass itself is not a plant pest, and no plant pest components will be involved in the transformation.” And on July 1, the USDA agreed, sending the Scotts Miracle-Gro Company official confirmation on Kentucky bluegrass’s regulatory status.

In 2000 the Plant Pest Act was expanded to allow the USDA to also regulate noxious weeds, and became the Plant Protection Act. This is significant, because we believe this provision gives USDA the authority to regulate GE Kentucky bluegrass: any engineered crop that threatens to go rogue in the field and become a hard-to-control weed may be regulated. In this case, pollen is light enough to be carried for miles in the wind, causing gene transfer with non-GE crops; and bluegrass spread rapidly.

However, even though the USDA admitted that GE bluegrass could be considered a noxious weed, the agency declared it still would not “cause impact significant enough to warrant regulation at the federal level”—a position we find both absurd and unconscionable.

We have several major concerns:

• Kentucky bluegrass is widely grown, and is used in parks and home lawns. This means the genetically engineered variety will have wide exposure indeed.
• This decision paves the way for any number of GE crops in the future to avoid USDA regulation altogether.
• If it is determined that a GMO is out of the USDA’s jurisdiction, the courts cannot demand that the USDA conduct full environmental impact studies under the authority of the EPA. This means other safety nets will disappear as well.

Our biggest concern, however, is the potential impact on our health. Since the USDA jurisdiction covers only plant pests and noxious weeds, there are very few studies of actual long-term human health affects of GMOs. In fact, most safety studies on genetically engineered products have been conducted by GE companies themselves! Furthermore, it is difficult to get the actual raw data for independent testing because GE companies usually keep data proprietary and seriously block independent studies.

A documentary series of nine films on GMO by German filmmaker Bertram Verhaag reveals the undemocratic, global conspiracy to push GE interests over those of the consumer. When he learned that only 5% of scientists working in the area of GE are truly independent, Verhaag started work on his most recent film, Scientists Under Attack. It documents two scientists conducting independent research about GE against pressure from industry, the government, and the scientific community.

However, what we do know about the health effects of genetically engineered crops is frightening. In a letter to USDA Secretary Tom Vilsack, retired Purdue University professor Dr. Don Huber wrote that a newly discovered and widespread pathogen is damaging the health of plants, animals, and possibly human beings. Glyphosate (the active ingredient in in Roundup, the herbicide many crops are engineered to be resistant to) may be weakening its plant and animal hosts making it susceptible to this pathogen, which is similar to the way HIV works. The pathogen has been found in high concentrations of the Roundup Ready soybean meal and corn used in livestock feed. Lab tests confirmed presence in the organism of pigs, cattle, and other livestock that have experienced spontaneous abortions and infertility. Plants containing the pathogen are stricken with disease.

With the help of Greenpeace, biologists from two French universities obtained a court order to force Monsanto to hand over its findings from animal studies they had used in its assessment that three varieties of GE corn were safe. After analyzing Monsanto’s data themselves, they discovered “statistically significant” evidence that the crops could poison the liver and kidney (the body’s main detoxifying organs). They also found pesticide residues in GE crops and animal feeds that were high above safe levels—which could affect the endocrine system.

Even worse, they found that that Monsanto’s tests were purposely designed to obscure the results. The test involved only 80 rats and 320 control rats, instead of equal numbers of both. And the longest study was just 90 days long—which isn’t enough to show long-term effects. The results were published in the International Journal of Biological Sciences.

NaturalNews.com has called for a boycott of the Scotts Miracle-Gro Company and all its products. If you wish to participate, please visit the Natural News boycott page to learn more.

Monopoly utility companies across the country are installing radio frequency “smart meters” in your home. If you don’t want them, too bad: it’s take them or live without electricity. Meanwhile, RF is being investigated as a carcinogen.

Smart meters (including the SmartMeter, a trademark of SmartSynch, Inc.) are digital meters that have been increasingly in use since the 1980s. The new radio frequency (RF) smart meters include a small one-watt radio that allows two-way communication between the customer’s home and the utility company. A smart meter transmits non-ionizing radio waves, just like cell phones, baby monitors, microwaves, and Wi-Fi.

There are a number of health concerns with the smart meters. The California Council on Science and Technology, the FCC, and the FDA all claim this technology is safe. However, as early as 1972, there were already over 2,000 studies showing negative health effects from RF radiation.

Most of the research has centered on cell phones. There have been multiple reports, mostly out of Europe’s premier research institutions, of cell phone use being linked to brain damage, early-onset Alzheimer’s, senility, DNA damage, and even sperm die-offs (many men, after all, keep their cell phones in their pants pockets or attached at the hip).

In 2008, scientists from thirteen European countries reported that after a decade of cell phone use, the chance of getting a brain tumor—specifically on the side of the head where you use the phone—goes up as much as 40 percent for adults. An independent study in Sweden last year concluded that people who started using a cell phone before the age of 20 were five times as likely to develop a brain tumor. Another study reported a nearly 300 percent increased risk of acoustic neuroma, a tumor of the acoustic nerve.

Louis Slesin, who has a doctorate in environmental policy from MIT and in 1980 founded an investigative newsletter called Microwave News, suggests that much of the comfort of our modern lives depends on not caring, or refusing to recognize the dangers of microwave radiation. “We love our cell phones. Americans are not asking the questions, maybe because they don’t want the answers.”

Certainly the government does not seem to want any answers. Early on, it exempted cell phones from any FDA review, principally because the telecommunications industry asked it to do so.

As for smart meters, there have already been thousands of reports of negative short-term health effects where the meters are already in place. Complaints range from dizziness to heart palpitations, migraines to sleep disturbances, exhaustion to forgetfulness and confusion, nausea and vomiting to constant thirst, increased blood pressure to anxiety and an overall decrease in functionality. These reports, like drug or supplement adverse event reports mentioned in our other article in this issue, represent correlation rather than causation, as scientists say. But clearly more investigation is needed. One should also consider the cumulative effect of radiation exposure from the other wireless technologies coupled with this new wave of radiation.

The World Health Organization previously claimed RF technology posed no threat, but recently reversed its stance, classifying cell phones as “possibly carcinogenic.” President Obama’s Cancer Panel also recently issued a cautious recommendation of limiting exposure to RF wireless technology, calling cell phones a possible carcinogen. While both WHO and the Cancer Panel are careful to say that the technology was only “possibly” dangerous or carcinogenic, it is significant that such important bodies should—in the face of RF’s widespread use—say anything cautionary at all about it.

Radio frequency radiation is also currently under investigation as a carcinogen by the National Toxicology Program. Children are far more susceptible to the effects of microwave radiation than adults due to their thinner skulls and developing DNA. The science is at best inconclusive. If scientists worldwide cannot agree about the safety of these meters, surely that is reason to give pause before their mass deployment across the country.

There are other concerns as well. Smart meters are vulnerable to hacker attack. A sophisticated hacker might use the data to figure out when you’re away on vacation and your house is vulnerable to burglary. And if a hacker were to infect smart meters with malware, it could disrupt the electric grid and cause widespread power outages. According to CIA director Leon Panetta, hacking into the Smart Grid “brings down the financial system, brings down our government systems. You could paralyze this country. And I think it’s a real potential.”

Moreover, smart meters may suffer from problems with billing accuracy. Two major utilities in Texas have confirmed that some customers received inaccurate and sometimes inflated bills after turning to SmartMeters to measure their energy usage. And PG&E, which provides gas and electricity to two-thirds of California, also admitted to inaccuracies with the meters.

The Maryland utility company PEPCO has announced plans to install smart meters in Prince George’s County and Takoma Park beginning this summer. At present there is no opt-out option in Maryland for the smart meters.

Even if one were able to opt out, however, one could still be sickened by a neighbor’s device, at least in the confines of an apartment building. Of course, if you refuse to allow the smart meters, the company will threaten to turn off your power completely.

The extent of this issue depends where you live in the country. In many areas there is only one power company. In others, options may exist, but because there is only one infrastructure—one set of power lines—even if you purchase your power from an alternate company, the power still travels down the lines of the primary power company to your home and is metered by that power company. So if you purchase 5 kwh of power from a wind farm, the wind farm will pump 5 kwh into the power grid, which is operated by your vertically integrated power company (PEPCO, PG&E, etc.). Either way, there is a monopoly company that can shut off your power.

In Virginia, for example, the power company Dominion Resources Inc. plans to install smart meters to all their customers’ homes—and they have already installed half of the Smart Grid meters in Charlottesville. If you choose not to use the smart meters, you choose to have no grid power at all—and that is not a viable choice for most people.

This situation can be changed! Every state in the US has a public utilities commission (PUC). The exact powers and authorities given to a PUC vary from state to state, as each PUC was created by state legislation, but most PUCs are to some degree under the control of the state legislature, in the sense that their mission is to enforce state code as it relates to utilities. Legislation at the state level can be written to ban or, at the very least, allow customers to opt out of having a smart meter without losing their access to power altogether.

Maine residents have secured the right to opt-out of smart meters, but they must pay a penalty surcharge.

Many local jurisdictions in California have banned or issued moratoriums on smart meters, but the electric utility claims the bans are not legally enforceable and smart meter installation continues in much of the state. An opt-out plan for California will be voted on by the California PUC later this year. We will keep our eye on this and will issue an Action Alert at the proper time.

A plan to install smart meters throughout Maryland was killed last summer, but as we noted above, a new plan is now moving forward with installation in Prince George’s County and the incorporated city of Takoma Park (both of which border Washington, DC). And further north, Baltimore Gas and Electric will begin installing smart meters in all the homes, businesses, schools, and clinics in its jurisdiction beginning in October, 2011, and plans to have the Smart Grid “fully operational in mid-2014.” Maryland Residents Against Smart Meters (MRASM) has been organized to oppose the installation.

If you are a Maryland resident, please write to your legislators and the Maryland Public Service Commission today. Ask them to mandate an opt-out provision for the installation of smart meters.