U.S. Institute of Medicine Study Urges New Approach to Regulating Supplements – Big Pharma Influenced Doctors Get it Wrong Again

May 18, 2010
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stethoscopeThe U.S. Institute of Medicine represents the heart of the medical establishment. Congress listens to it. The President listens to it. The FDA listens to it.

In this case, the FDA’s Center for Food Safety and Applied Nutrition posed some technical questions to the Institute of Medicine. Please note that this FDA center is in charge of regulating dietary supplements. Unfortunately the Institute of Medicine decided to go beyond the technical questions posed and instead chose to recommend a new approach to regulating supplements. A lot of what the IOM said was wrong, but let’s take it from the top. View the report here.

1) The IOM seems to think that healthy foods and supplements should be regulated like drugs. “There is no scientific rationale for having different levels of rigor applied to these different categories,” said Dr. John Ball, chair of the committee that produced the report.

Really? The distinguished scientists on the IOM panel should be able to understand that natural products cannot be patented and therefore cannot be brought through the obscenely expensive FDA approval process required for drugs. Who does the IOM or FDA expect to pay a billion dollar cost of approval for cherries or walnuts? Individual cherry or walnut growers? Will consumers buy cherries if they cost as much as drugs?

This is what we have called the Catch 22 of contemporary American medicine.

Because only non-natural and patentable substances can be brought through the FDA approval process, the FDA in effect enforces a medical monopoly for drug companies. As a direct consequence, natural and often much safer and cheaper natural remedies are ignored. Natural medicine based on diet, dietary supplements, and lifestyle, which ought to be at the center of medicine, are shunted off to the sidelines and subjected to legal threats by hostile regulatory agencies.

By the way, how safe are all those drugs that go through the FDA approval process? In 2008, the FDA received more than 530,000 reports of suspected adverse drug effect, there were 320,000 serious adverse events and nearly 50,000 deaths reported. A report in 2007 by the FDA, CDC and U.S. Consumer Product Safety Commission found that common drug dangers are so bad that “Harmful reactions to some of the most widely used medicines – from insulin to a common antibiotic – send more than 700,000 Americans to emergency rooms each year.” View the report here.

2) The IOM also seems to favor strengthening FDA authority over supplements and allowing the agency to pull supplements because of vague concerns, not just the current standard of “significant or unreasonable risk.” The report cites a study on beta-carotene as partial justification for this, but clearly hasn’t bothered to look into the seriously flawed science behind the study. This recommendation again misses the central point: it would be nice to pay for a billion dollars of study of each component of our diet but who will pay for this? Medical costs are already completely unsustainable and food prices are rising. Do we really want to regulate functional foods and supplements out of existence? The drug companies of course would like that very much—no more competition.

3) IOM also doesn’t like the idea that a supplement intended for bones (containing vitamin K, D, calcium, and other minerals) may currently cite accepted claims for vitamin D or calcium. No. The IOM committee thinks that the entire product in each case should be required to be researched as a whole and nothing whatever said about component vitamin D or calcium benefits. Never mind that the report also says that “in order to make informed decisions  individuals need access to complete information.”  How is the public to get any information, much less complete information, with these irrational government gag orders in place?

ANH-USA has a guess about what is bothering the distinguished committee members. None of us like to see sugary cereal makers claiming health benefits for their cereals because they have sprayed on a few cheap synthetic vitamins. But let’s not throw out the baby with the bath water. Let’s have a little common sense. The bone product should be able to cite the vitamin D claim. Otherwise the purchaser is left in the dark. And the cereal maker should be required to be honest about what else is in the cereal.

4) The report says that its recommendations are “consistent with recent efforts to improve the use of science at FDA and in European Regulatory Agencies.” The bare truth (as pointed out by ANH-Intl’s Dr. Rob Verkerk in a series of peer reviewed scientific journal articles) is that the science used by the European Regulatory Agencies is very poor science and is getting worse, not better.

5) The IOM report makes some good points too. For example, it notes that the FDA relies heavily on so-called bio-markers in approving drugs and there isn’t enough or consistent science behind this. For example, it is taken almost on faith today that a cholesterol lowering drug (cholesterol is the bio-marker) will reduce heart disease and lengthen life. This is naïve: cholesterol is not an illness in itself; indeed we cannot live without it. And the drugs used to reduce cholesterol are quite dangerous. Similarly reduction of blood pressure (a bio-marker) is assumed to be “good” without considering the side effects of the drugs that produce it.

We agree that bio-markers are being misused at the FDA. But that does not mean that drugs and supplements should be subjected to identical research requirements.

In general, we must always be wary when conventional medicine calls for greater scientific “consistency.” That is often just an excuse for choosing some valid science and excluding some other, equally valid science for ideological reasons.

For example, did you know that the phrase “evidence based medicine,” as used by conventional medical research, means accepting the kind of human trials currently demanded by the FDA and rejecting all other forms of scientific evidence? This is true even though food in particular cannot be studied in the same way as a drug. It has multiple ingredients and effects which interact with other multiple ingredients and effects in ways that cannot possibly be isolated.

There are rumors on Capitol Hill that an upcoming Congressional hearing will address the supplement issues raised by this poorly thought through IOM report. We have our ear to the ground and will keep you informed as we learn more.

71 Responses to “U.S. Institute of Medicine Study Urges New Approach to Regulating Supplements – Big Pharma Influenced Doctors Get it Wrong Again”

  1. Margo says:

    I guess RJ23 and Jake are plants, because they misrepresent every salient issue. I bet they take their share of Pharma products are are proud of it and all the side effects they get are their badge of loyalty and courage to the paychecks they get from their “bosses”.

    I wonder how they will feel 20 years down the road when their health is ruined and they have no one to blame but their own “loyalties”. The choice is still all theirs. But if the world goes totally Pharma, neither they, nor I, will have choices.

    And testing something like God given food that has been feeding the ungrateful Pharmas for 6 thousand years, costing millions for each test, isn’t that like “Humans with an Agenda Testing God?” Where is the Far Right on this issue? Isn’t it possible that Human Pharmas are getting a little uppity, poking God in the eye with Regulatory Fingers? Who is going to stand up for the good old Earth Created Food of the eons. Where are the real Bible people? I call you out to do real good for the Earth. Stop GMO’s and Pesticides, and do not support Regulation of Supplements. Some people depend on supplements because doctors made such horrible mistakes that they, like me, cannot turn to anyone for help but organic foods, juicing and supplements to maintain what is left of their health.

    RJ23 probably expects to get paid for the work he does. Does it make sense that Supplement manufacturers should work for free? He is, quite frankly, really out of his mind. And the word “natural” being exploded all through his comments; well, true organic standards used to mean no chemicals in the food or supplements at all. Now natural means whatever the Pharmas say it means. When I see the label “All Natural”, I steer clear. It says Pharmas’ had its paws all over it.

    Poor RJ23 and Jake. No brains at all. Just rhetoric.

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  2. Jake says:

    In response to “Lou”

    Why do you think food and supplements are “non-toxic”? If they are non-toxic why do people have reactions to them? You do realize that the drug adverse reporting is required and there is no requirement for supplements since there is no record of people taking them. Supplements can fail to contain what the label clearly states and there is no way to know as they are NOT TESTED.

    I’ll admit I’ve yet to read this new report by IOM, but I agree the dietary supplement industry needs more regulation. The prescription drug industry is definitely screwed up, but the complete lack of any safety measures in the dietary supplement industry is also screwed up.

    One thing everyone should remember: Just because a product is “natural” does not mean it is SAFE. Nature makes many poisons without the help of the all-evil drug companies.

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    • RJ23 says:

      Very good point Jake! Thank you for making it. I also agree the Pharm companies are screwed up but people have this delusion that if it’s “natural” it must be good for me and “the more the better!” It’s also interesting to point out that many drugs out there marketed by Pharm companies were actually isolated or developed from “natural” products. Think “digoxin” and digitalis. Think “Lovastatin” and red rice yeast and so on. Some of these “naturophiliacs” are so paranoid about o’naturale that they’ll take pounds of supplement pills every day which, as you pointed out well, may or may not contain what they say it is BUT these same people won’t even touch something that has been studied and may have some potential side effects but also potential benefits. It’s all a balance of risk versus benefit. Nobody every said medicines are without side effects or risk but the nature lovers will always say “100% completely safe, risk free, NO side effects!” That’s BS. With the current state of supplement regulation, I could mow my lawn, bag the grass, grind it up, put in a capsule, label the bottle as “Natural Super Health Pill-Supports Health” and sell it! And somebody posted something above about “there’s no money in supplements”. Well, that is completely false. The supplement industry is a billion dollar industry. Nobody wants to study something that is natural though because “if it’s natural, IT MUST BE HEALTHY!”

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  3. Ken Smith says:

    I would like to know is going to pay the members of congress and the drug companies and FDA when all of the ordinary people have been killed by the poisons that are being forced on the american people. Leave the supplements and organic food alone.

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    • Ann Curtis says:

      I have often wondered the very same thing. After the NWO kills off the 90% of the world’s population–which is their goal–who is going to be able to live on the earth when the ground is unable to harvest nutrient-worthy food? If only 10% of the world’s population is left–assuming the people are in good health (which I would sincerely doubt)–then how do they expect everything to be done? It’s said that the NWO wants that 10% (or 9%, if the elite comprises the 1%) to be “slaves.” Well, that’s all fine and dandy, but if they completely corrupt our current planet to the point that everything is poisoned–how do they justify that they can live healthy and not die off like the 90% they killed off?

      I mean, once the planet is so polluted that nothing can grow and the water is dead–how do they expect anyone or anything to live? Do they have special lands and water set aside that they will use to grow food and drink from, so that they can keep on living on a dead planet? I seem to be having a bit of a problem wrapping my mind around how the NWO plans to live on a planet that they are currently killing. I also wonder if the NWO people have thought through any of this. If you’re currently poisoning the planet and the people to kill them off…well, doesn’t it stand to reason that you also have to eat and drink and breathe the same poisons? So how does that leave them to rule and have “slave labor,” if, in theory, they will end up just as sick as the rest of us? Maybe they’re hoping medical science and drugs will save them? If so, they’re even more dellusional than we think they are…

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  4. Thomas says:

    All good comments & points regarding yet another nefarious effort, to infringe upon our ever eroding freedoms…

    To quote from poster Christina, “They have an agenda and it certainly isn’t to keep the public healthy.” Very sad, & all too true. It is an outrage how the gov’t continues to overstep it’s bounds — and WE must continue, to make our voices heard.

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  5. prizes says:

    I enjoy reading this site. Could let me know how I could keeping up to date with it? By the way I found this site through Aol.

       0 likes

  6. I cannot believe health insurance premiums continue to rise as they have been. We have individual (i.e. family) coverage, and the rates for our family of 4 have increased over 30% in each of the last 3 years. This does not include a change in our age group. That will be coming next year as I turn 40. This rate of cost increases cannot continue. What’s going to happen to people who make less than we do? (And are typically younger, and who typically make less money.) They will start to drop off of the lists of those who have insurance. And the cycle continues. Does the federal health care reform change any of this? For us it’s only a matter of time before I either have to drop off the roles of the insured, or change my lifestyle completely by selling my house, or worse. Maybe we’ll have to move to Europe, where coverage is mandatory.

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    • TAO says:

      True, and with the current economy who CAN afford it. I have been without it most of my life, and at 54, I am still unable to have it, so I do the best I can by supplementing, juicing, and exercising. Europe sounds wonderful.

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    • AJM says:

      There is no need to sell your house or any other drastic measures. If every citizen would commence to change their diets and stop taking pharma drugs, exercise regularly and supplement with vitamins and minerals (because we don’t get what we need entirely from food anymore because our soil has been so depeleted due to the govt subsidizing farmers!), we would NOT NEED health insurance coverage.

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  7. Christina says:

    The recent attacks on supplements and the strong efforts to have everything regulated is depressing, worrisome and infuriating. I literally would not be able to maintain my good health today if it weren’t for supplements. Where western medicine completely failed me in resolving health issues, supplements and alternative and natural healing have restored my good health. Without the ability to maintain it, I would be back to having issues. How dare these people attempt to tell the public what’s natural and healthy and what’s not! They have an agenda and it certainly isn’t to keep the public healthy. I’m angry over the recent attacks and efforts to regulate and control supplements and encourage everyone to make their voices heard on this subject, contact your representatives and stop this from happening!

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  8. Lou says:

    Let me get this straight

    Pharm Drugs are

    o Toxic
    o Expensive
    o Do not address causes
    o Politically protected

    Food and Supplements are

    o Non-toxic
    o Inexpensive
    o Address Causes.
    o NOT politically protected

    So the establishment “medical board” says we should have more of the pharm poison and less of the cause addressing natural means.

    Yeah it figures. One of the ways this country is being destroyed is through the poor health of its Citizens.

    Thanks Traitors

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    • TAO says:

      So very true, I am 54, I have seldom seen a doctor, because I use natural supplements and exercise. And if I need a doctor, it will be a naturalpath, wholistic one. Most people I have seen who do take “poison” medicine only get worse period.

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    • charles kafka says:

      what “they” are leaving out of course,
      is that drug development and testing is all done by corporate welfare.
      We the people (as opposed to “they”)are paying for this anyway.
      but the pharmaceutical companies won’t research herbs, food, and supplements, because there is no money in it! With our money!
      Evil.
      Evil plain and simple.

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    • Jerilyn Capaccione says:

      I am totally against natural health products being regulated by the FDA. My daughter took antibiotics for wisdom teeth problems for almost 4 years now and now because of taking all these antiobiotics (pushed by dentists and doctors) she has a problem with her eustachian tube and can’t get rid of it. We have spent $$$$$$ (natural dollars not conventional because that is what caused the problem in the first place) and still no relief. She’s been to numerous doctors for the problem and can’t get rid of it. I am so angry right now about antiobiotics being pushed on us it isn’t funny! There are natural means to help physical problems and they work–they’re not fake!!!! When is everyone (including the FDA) going to wake up and see the sunshine–we are being killed by antiobiotics and no one wants to admit it!!!!! Antiobiotics are yeast and anyone can research yeast in the human body and see that when you get a super overabundance of yeast in your body, your body is going to react and people can actually die from too much yeast in the organs of their body! Wake up people. I personally don’t want to die just because my organs have been overloaded with yeast in one way or another. My daughter is totally frustrated with the fact that she had to take the antiobiotics and now she might have to live with tihs problem the rest of her life!
      No, the FDA SHOULD NOT BE CONTROLLING NATURAL HEALTH PRODUCTS………..
      Jerilyn Capaccione

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      • ks20 says:

        Hi Jerilyn You should get your daughter tested for Candida. Since she was on antibiotics for so long she probably now has systemic Candidas. Candidas is know to attach the eustachian tube among several other organs and body systems. I would hate to tell you what being on Antibotics has done to my system attacking my Thyroid, Adrenal glands, intestines, liver, and causing a mutlitude of other problems.

        Candidas is a very serious problem and you must get her checked out right away. There is a very simple spit test she can do to see if she has it. IF it is possible then go get the blood test and have them test her IgG, IgA, IgM. The simple spit test is get a clear glass with no design and fill it with water. Put it next to her bed and the first thing in the morning before eating or drinking she should spit into the glass then see if the spit forms strings, or sheets and or falls down to the bottom of the glass. The faster it falls the more serious it is. For example mine falls with in the first 3 seconds and it really bad. If it takes an hour then she is lucky and may only have a minor Candidas infection which could be cured using natural cures.

        Good luck and dont wait. It only gets worse and worse. Google it for more info on it.

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    • Angelic Pure Water says:

      A THOUGHT FOR THE WISE

      The drug industry is constantly trying to convince you that drugs are good for your health while nutritional supplements and healthy foods are somehow bad for you. This same line of nonsense is also repeated by the FDA, which goes out of its way to censor the truth about the healing properties of natural foods like walnuts, cherries and berries, and most importantly drinking pure water. (http://www.anh-usa.org/wp-content/u…)

      http://johnellis.com

      The drug industry and the FDA are, of course, just plain wrong about all this. Although their advertisements show happy, healthy people taking pharmaceuticals, in the real world, people who take their drugs are extremely unhealthy, depressed and highly toxic.

      But don’t take my word for it: Check out the people walking in and out of pharmacies versus the people who visit health food stores:

      • People who visit pharmacies tend to have toxic livers, poor kidney function (because drugs damage the kidneys), wild mood swings, terrible digestion and elimination capabilities, poor skin health, poor posture, low energy, sleep disorders and sexual dysfunction. They tend to be suicidal while living in chronic pain. They have huge medical expenses that often send them into bankruptcy.

      • People who visit health food stores tend to have healthy skin, happier outlooks, better energy, better sex lives, healthy sleep, healthy hearts, healthy liver function and greatly improved brain function. They are more creative, adaptable and optimistic, and they tend to enjoy their lives. They spend relatively little on health care expenses while investing their money in organic foods, green products, medicinal herbs, nutritional supplements. And, drink pure water!

      The choice is up to you
      Which group would you prefer to join? You can choose either one by deciding what to put in (or on) your body. If you choose to contaminate your body with pharmaceuticals and medications, you will experience increased liver and kidney toxicity, reduced cognitive function, skin health problems, sexual dysfunction, mood disorders and other such problems.

      On the other hand, if you choose to nourish your body with superfoods, organic products, healing herbs, nutritional supplements, and pure drinking water, you will experience a more healthful and joyful life with improved brain function and memory, healthy skin, stable moods, abundant energy, restful sleep and healthy fertility, among other benefits.

      The pharmaceutical industry wants you to choose their drugs, of course, and they don’t care what happens to your health and happiness as a result. In fact, the worse your health gets after taking their drugs, the more of their drugs you’ll need! The side effects of one drug become the “disease” that’s treated by another drug, so it’s all great for repeat business!

      Keeping you ignorant
      What the drug industry and the FDA absolutely do NOT want you to learn is that healing foods, herbs and supplements, and DRINKING PURE WATER make virtually all pharmaceuticals obsolete. If you really knew the truth about what these items can do to protect your health and cure degenerative disease, you’d probably never take another chemical pill in your life. That’s why the FDA works so hard to censor nutritional supplements and make sure they can’t make truthful, scientifically-validated claims on their labels. (http://www.anh-usa.org/tell-the-fda…)

      The FDA has even gone after healing foods AND MANUFACTURERS OF PURE WATER MACHINES to keep you from knowing that they do indeed prevent health problems, and cure those that have them. The scientific literature says conclusively that walnuts lower high cholesterol. It’s the natural result of eating the healthy plant-based oils in the walnuts. The FDA, however, has threatened walnut companies with fines and imprisonment for merely linking to scientific studies that describe the health benefits of walnuts.

      This is how the FDA keeps people in the dark and achieves its agenda of censoring the truth about foods and supplements while promoting toxic pharmaceuticals that keep the drug companies in business, health insurance costs that are out of sight, and medical practitioners on their yachts.

      Change your decisions and you’ll change your life
      It’s up to you to determine how the rest of your life will be experienced. If you continue to find yourself standing in line at the local pharmacy, or if you look in your medicine cabinet and notice a half-dozen prescriptions, let that be a wake-up call. These drugs will never give you health or happiness. They will never create the life you’re truly looking for.

      Instead, take a walk to the other side of the street. Walk into your local health food store. Ask the friendly staff how to get started with healthy living. These people are incredibly helpful, by the way, so don’t be afraid to ask questions.

      Spend your money at the health food store and start producing pure drinking water at home instead of the pharmacy and your entire life will improve as a result. As you improve your physical health, your brain health will get better, too, and you’ll notice life getting better in many ways: Improved relationships, enhanced career (because having a healthy mind improves your job performance, too!), improved self image, increased stamina and much more.

      You’ll sleep better, eat better, think better, poop better and feel better. Everything your body is supposed to do naturally will simply work better as you align yourself with the natural laws of health and nutrition. You can embrace those laws by visiting practically any health food store and taking advantage of the remarkable health-enhancing products they carry.

      So find your local health food store and give them a visit! And definitely buy a JOHN ELLIS ELECTRON LWM-5 Living Water Machine. The best investment you’ll ever make – as they say, you can’t buy love, but you can buy GOOD HEALTH!

      Remember, you vote with your dollars — both in terms of what industries you support as well as what health outcome you will create. If you invest your dollars in natural health products, you will get a healthy result.

      Compliments of “Angelic Pure Water”, Dealer/Distributor for Mr. John Ellis’ Electron LWM-5 Living Water Machine
      (775) 990-9845

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  9. Ann Beckett says:

    I have a rare genetic disorder that results in the stripping of zinc and B6 from my body. The only way I can be functional is to take 5,000x the recommended daily amount of B6 and 7x the recommended daily amount of zinc. Without it I am debilitated (and was for years before receiving having been correctly diagnosed, which was the result of my own research; no doctor or practitioner had been able to figure out what caused my chronic debility). The FDA has already taken the most common form of vitamin B6 off the market and given it to a drug company for its sole proprietary use. They did the same with the weakest and safest bioidentical hormone used for hormone replacement, estriole. There is talk that omega 3 fatty acids may be next (this from my optometrist). My life depends on my access to unadulterated supplements. It could easily be sacrificed to the greed of pharmaceutical companies and the corruption of an agency of the our government. And of course we pay the taxes that support this corruption.

       0 likes

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