U.S. Institute of Medicine Study Urges New Approach to Regulating Supplements – Big Pharma Influenced Doctors Get it Wrong AgainMay 18, 2010
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.