Sunday, January 13, 2008

Dietary Supplement "Safety" & "Risk Assessment"

Dietary Supplement “Safety” and “Risk Assessment”:

Observations on the Role of the Media

Richard Malter, Ph.D.

© 2005

During the past 20 years, I have had numerous opportunities to observe the manner in which the media have covered health issues in general and dietary supplement “safety” and “risk assessment” in particular. My overall impression is that journalists and the media are easily manipulated when it comes to many health issues, especially those related to dietary supplements. The media provide extensive coverage when the “safety” of dietary supplements is raised by so-called “research” studies or by the FDA and other sources of press releases. The media provide a great deal of publicity for what are clearly anti-supplement views. This most often occurs before experienced professionals can properly respond in appropriate professional channels. This state of affairs often results in negative impressions about dietary supplements being set in the public’s mind before the content of these negative press releases can be properly challenged and rebutted. Invariably, professional rebuttals are rarely if ever picked up by the media so that the negative media impressions about dietary supplements are not changed.

In my view, many of the “research” studies and reports of “expert” committees regarding individual dietary supplements (most recently, vitamin E) and the broad category of dietary supplements have had a frightening or confusing effect on both the general public and health professionals. The recent highly publicized vitamin E study was a “meta-analysis” of many different vitamin E studies that were generally done with subjects over 60 years of age who had one or more serious health conditions. Despite the fact that there were many flaws in this particular vitamin E study, it was highly publicized before it was even published or critically reviewed. But, this seems to be a standard procedure when handling negative views of dietary supplements. Research professionals provide the pre-publication research results to journalists and the media who lap them up and alarm the public, legislators, and health professionals. This is essentially a public relations ploy that reports what Dr. Abram Hoffer refers to as a “factoid” rather than a true fact. Factoids usually are distortions or exaggerations that are presented as facts that are later refuted.

In regard to the activity of several “expert” committees that have issued reports about the “safety” or “risk assessment” of dietary supplements, Dr. Alan Gaby observes in a recent article:

The apparent anti-nutritional-supplement, anti-self-care bias that permeated the process of setting safety limits is evident both in the way in which the SUL was defined and in the fact that the benefits of nutritional supplements were purposely ignored. The SUL was defined as the maximum dose of a particular nutrient "that potentially susceptible individuals could take daily on a life-long basis, without medical supervision in reasonable safety." In other words, it is the highest dose that is unlikely to cause anyone any harm, ever, under any circumstance. Furthermore, the EVM ("Expert Group on Vitamins and Minerals", was specifically instructed not to consider the benefits of any of the nutrients, and not to engage in risk/benefit analysis.” (italics added)

In a similar manner, the US FDA also commissioned a study of dietary supplement “safety” by a committee of “experts” with the stipulation that the committee only examine “safety” and “risk” factors related to dietary supplements, but NOT benefits of these vital supplements. This is a curious state of affairs when we note that, both in England and in the US, government agencies that have a regulatory interest in dietary supplements commissioned studies of “safety” and “risk” factors related to dietary supplements, but with an explicit directive NOT to consider supplement benefits. These conditions immediately set up a BIAS in the work of each committee. Yet, the final reports of each of these committees are to be viewed as “scientific” documents. These documents then are to be used to support legislative action that would either re-define dietary supplements as “drugs” or would severely restrict the dosages and the ready availability of these vital supplements to the public. The FDA also selects the so-called “experts” that appear before Congressional committees to provide the kind of spin that the FDA wants in order to manipulate the legislative process.

The built-in bias in the work of these “expert” committees tends to grossly exaggerate “risks” and “safety” issues related to dietary supplements with no possibility of providing proper balance with a review of the many different health benefits of these vital supplements. Whereas, a “risk/benefit” model is routinely applied to the review of even the most dangerous prescriptions drugs that kill or maim thousands of people, the FDA and its English counterpart explicitly directed their “expert” committees not to consider benefits of dietary supplements, but only “safety” and “risk” issues. These biased directives by the FDA and its English counterpart clearly remove these “expert” committee reports from the scientific domain and squarely place them in the political/ economic domain. From this perspective, it is important to ask, “What is the real agenda of the FDA and its English counterpart vis-à-vis dietary supplements? What kind of additional power and control over dietary supplements are these governmental agencies seeking? What are the implications for the public health of legislating greater power and control over dietary supplements by government agencies? Who are the people behind this dietary supplement agenda that seeks to use “experts” to lend a scientific aura to the writing of inherently biased reports about dietary supplements?”

In regard to the FDA’s latest approach to determining the “safety” of nutritional supplements, embarrassing describes this new paper that the National Academy of Science has just put out. I struggled reading through the first 1/3 of their supplement safety paper. Reading it is even more tedious than reading the NAS Risk Assessment paper they wrote a few years ago that I wrote a rebuttal to. Except for the fact that an esteemed group was assembled to write this abomination of “science” and they selected 6 nutritional supplements to apply their new hypothetical safety model to, it is hard to detect anything in this new NAS paper that is related to nutritional supplements in any meaningful way.

One of the noteworthy elements in this NAS supplement safety paper is a “flow chart” of steps for FDA to take to assess the safety of supplements. It is a very elaborate 3-stage flow chart with arrows going in different directions depending on whether a question is answered “yes” or “no”. It looks and sounds very scientific to the person who is unaware of what is really going on.

As far as safety and health issues are concerned, in my view, the most important and valid flow chart is shown below. I call it the “Conflict of Interest Flow Chart.”

Conflict of Interest Flow Chart

FDA <----------------------->Drug Companies<---------->Universities/Med Schools
As many of us know only too well, the flow of people between drug company employment or consultants, the FDA, and the Universities and their Medical Schools makes it very easy for the drug companies to corrupt the entire healthcare system, including research having to do with the effectiveness and safety of drug products. The toll that this corrupt system takes every year in human lives and the damages to people’s health is appalling.

There is also an inherent conflict of interest when the drug companies are in the nutritional supplement business, especially when they buy up existing supplement companies that have established good reputations for high quality products. We have already seen how blatantly dishonest some drug companies have been with the price fixing of raw materials for manufacturing supplements and the hundreds of millions of dollars of fines that were levied on them.

This case of price fixing raises serious questions about the integrity of drug company business practices and the integrity of any drug or supplement research that they are involved in. In fact, we could reasonably say that they have corrupted large segments of the research and healthcare community in both the physical and mental health sectors. Under these circumstances of such blatant corruption, how is it possible to trust any research carried out and submitted by any drug company today?

A strong case could be made that drug companies should be compelled to divest themselves of any of their interests and control over nutritional supplement companies. The involvement of drug companies in the ownership and operation of supplement companies has a serious adverse impact on the operation of a free healthcare marketplace affecting competition, pricing, and availability of a good quality, safe and inexpensive nutritional product. In many cases, nutritional supplements are direct competitors of drugs and medications in both function and effectiveness.

A perfect example of this point is the comparison of a good magnesium supplement with a calcium channel blocker medication. Magnesium is “nature’s” calcium channel blocker (in addition to the more than 300 known functions of magnesium in the human body). It is much safer and far less expensive than a calcium channel blocker medication that requires a prescription and also carries serious health risks (such as death.) A high quality chelated magnesium supplement (100 mg) costs about $7 retail for a bottle of 90 tablets. Clearly, magnesium is a major competitor of calcium channel blockers (and other expensive and dangerous blood pressure medications for that matter.)

If a drug company markets a very expensive and highly profitable calcium channel blocker as well as a cheaper magnesium supplement through its supplement company subsidiary, there is a high probability that the drug will be marketed and promoted much more intensively than the safer and cheaper magnesium supplement. The parent drug company is likely to exercise control of its supplement subsidiary to the detriment of the health of its patient consumers in order to maximize its profits by selling the far more expensive, but much more dangerous medication.

The ImClone scandal is an excellent example of the financial incentives involved in drug research and getting FDA approval to market a new chemical substance. When we’re dealing with the invention and patenting of new drugs, there are enormous financial incentives that lead scientists and business executives to stretch and distort the data (“lie”) in order to create the illusion of safety and effectiveness for their new drug compound. When it does get FDA approval, then it is aggressively marketed to unsuspecting people.

The Rezulin disaster with diabetics a few years ago is another good example of a company pressuring FDA to approve its drug even though serious safety and health risks were known. Rezulin had a lot of company with other recently approved drugs that were pulled off the market shortly after FDA approval because of deaths and health damage to unsuspecting patients. It’s really amazing how some of these new dangerous drugs get approval under the scrutiny of FDA’s well credentialed “experts” and, shortly after FDA approval, the real dangers of these FDA approved drugs show up with alarming numbers of patient deaths, liver damage and damage to other organs. This is often followed with FDA removal of these dangerous drugs after they have done so much damage (and after they have made a lot of money for the drug manufacturer.)

It is ironic that so-called “safety” studies of vitamins and minerals by the FDA and the “experts” that they rely on to do these questionable safety studies often refer to the risks that diabetics are exposed to by taking different nutritional supplements. The risks that diabetics take when they are given such toxic, poorly researched drugs as Rezulin are far greater than the risks they take with most nutritional supplements.

Now that attention has become focused on how corrupt corporate executives and accounting firms are in cooking the corporate books, it’s time to examine the corruption between the drug companies, the FDA, and other institutions of our healthcare system. What’s even worse about the FDA and drug company corruption is that the lives and health of our entire population are at stake as well as the integrity of the health sciences.

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