Risk Free Vitamins - How Safe is Safe Enough?

Categories

Health

Legislation

Recent legislative proposals on at least three continents have centered around the perceived need to ensure the safety of natural health products, such as supplements containing vitamins and minerals. Canada has proposed drug-style regulations for supplements. In the US, a proposal termed S 722 seeks to increase the FDA's powers to remove supplements from circulation. Australia recalled 1600 diverse health products in an unprecedented prelude to - what else - tighter regulations. Harmonization across the Tasman seeks to impose the already restrictive Australian rules on New Zealand. Here in Europe, a Directive on Food Supplements was approved, which many fear will remove thousands of hitherto safe products from the market in the name of "consumer protection". The transformation of this directive into national law is being challenged in a London Court by a coalition of groups and individuals made up of practitioners, consumers and a few manufacturers. The European Court of Justice will have to deal with the matter. As if that was not enough, Codex Alimentarius, an international standard-setting body for foods under the auspices of the World Health Organization is considering restrictions on Vitamins in international trade.

The one common line of justification for all this legislative fervour is: "Consumer protection". Hogwash, one might be tempted to say, when considering what New Zealand researcher Ron Law has found and described in a number of graphics: Vitamins and food supplements in general are by far the safest product category around. According to the government's own statistical data as published in prestigious medical journals and on government websites, supplements are far safer than even plain ordinary food.

On the other side, pharmaceutical medicines, correctly registered, approved and properly prescribed, are causing hundreds of thousands of deaths every year and have become a leading cause of death and injury.

So clearly, the consumer protection argument does not wash. Why protect anyone from something that is not dangerous while exposing them to government mandated medical peril?

Certainly there are pharmaceutical lobby interests that would be overjoyed at seeing severe restrictions for those pesky health foods that keep spoiling the bottom line. Business is business, to be sure. It is an essential trait of pharmaceutical business that it can only fluorish when illness is widespread. That is a hard fact, but one we tend to want to overlook - possibly we think we might be thought of as "uncharitable" with our fellows in the medical and pharmaceutical field, if we did bring up the subject.

According to the definition of a medicinal product in the EU and elsewhere, prevention is, along with diagnosis and cure, a characteristic part of what we consider to be part of medicine. But in real life, prevention is incompatible with the business of cure. If I can prevent all diseases, no one will need a cure. So who is going to believe that - when given responsibility for both prevention and cure - I will seriously work on prevention? Only someone who cannot put two and two together. The money is in the cure - not in prevention.

What laughingly passes for "prevention" in modern medicine, vaccination for one, lowering your cholesterol level for another - just to quote two egregious examples - is really an activity meant to drum up business for the "cure" department. We know that vaccinations are not exactly strengthening the immune system, and that cholesterol lowering drugs, to some, are outright dangerous.

These facts are pretty obvious to anyone paying attention. So how could it be that pharma lobbies have such an easy time convincing legislators of the "urgent need" to regulate supplements? What is the trick they are using?

Apart from slanted media reports and ordinary corruption, the pharma boys have hit upon a great idea: The "reasonable" evaluation of vitamin safety by high power pharmaceutical experts and the consequent setting of "Safe Upper Limits". This is such a seemingly reasonable request that it has already been enshrined in the European Food Supplements Directive and is proposed in upcoming Codex regulations. What reasonable politician would not want to agree to "scientifically sound" safety proposals for vitamins?

Unfortunately the "safety evaluations" so far proposed are hopelessly slanted - so much so that the "safe levels" arrived at in most cases are also "no effect levels" meaning that the levels are useless for preventing anything but the most severe deficiency diseases, which incidentally have no longer been with us for decades.

Alan Gaby has analyzed the question of "upper safe limits" on the example of the UK "Expert Group's report on Vitamins and Minerals". His article is being published in the Journal of Orthomolecular Medicine, in a Special Issue titled "The Safety and Efficacy of Vitamins". To get the full text with references, you will have to order the Journal, which also contains a number of other interesting articles. Here is a preview of the Gaby article:

"Safe Upper Limits" for nutritional supplements: one giant step backward
by Alan R. Gaby, M.D.

In May, 2003, the "Expert Group on Vitamins and Minerals" (EVM), an advisory group originally commissioned in 1988 by the then Ministry of Agriculture Fisheries and Food, and subsequently reporting to the Food Standards Agency in England, published a report that set "Safe Upper Limits" (SULs) for the doses of most vitamin and mineral supplements. The establishment of SULs was based on a review of clinical and epidemiological evidence, as well as animal research and in vitro studies. For those nutrients for which the available evidence was judged insufficient to set an SUL, the EVM instead established "Guidance Levels", which were to be considered less reliable than SULs.

This writer's analysis of the EVM report reveals that the dose limits were set inappropriately low for many vitamins and minerals; well below doses which have been used by the public for decades with apparent safety. While the release of this 360-page document would be of little import, were it to be used solely as a manifesto for the pathologically risk-averse, preliminary indications are that it could be used very actively to support the arguments of those who are seeking to ban the over-the-counter sale of many currently available nutritional supplements. If the report is used that way, then the public health could be jeopardized.

On May 30, 2002, the European Union adopted Directive 2002/46/EC, which established a framework for setting maximum limits for vitamins and minerals in food supplements. The EVM report is seen by the UK government as the basis for its negotiating position in the process of setting these pan-European limits.

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 was specifically instructed not to consider the benefits of any of the nutrients, and not to engage in risk/benefit analysis.

There is little or no precedent in free societies for restricting access to products or activities to levels that are completely risk-free. Aspirin causes intestinal bleeding, water makes people drown, driving a car causes accidents, and free speech may offend the exquisitely offendable. Politicians and bureaucrats do not seek to ban aspirin or water or driving or free speech, because their benefits outweigh their risks. For vitamins and minerals, however, some authorities seem to believe that unique safety criteria are needed.

Moreover, the government's instructions to disregard the many documented benefits of nutritional supplements introduced a serious bias into the evaluation process. As the EVM acknowledged, determining safety limits involves an enormous degree of uncertainty and a fairly wide range of possible outcomes. The committee might have established higher safety limits than it did, had it been told to weigh benefits against risks. The government's instructions appeared to be an implicit directive to err on the side of excluding doses that are being used to prevent or treat disease. And that is what the EVM did, often by making questionable interpretations of the data, and doing so in what appears to have been an arbitrary and inconsistent manner.

Riboflavin Guidance Level

A typical example of the EVM's dubious approach to establishing safety limits is its evaluation of riboflavin. The committee