Wednesday, June 6, 2007

Nutritional Supplements and the NCCAM

29,000 products and only two promising leads...are we getting our monies worth?

The nutritional supplement industry has had a long and fascinating history of promoting its wares through a variety of means that consistently seem to skirt normal venues of therapeutic product requirements. If you look through the supplement inventory it quickly becomes apparent that many of these products implicitly claim to have clear uses very much in line with what is considered a drug like treatment- only with out the caveat of being carefully scrutinized by an outside party like the FDA for efficacy and risk.

What is interesting is how this industry ran with the progressive weakening of oversight over the past 20 years, taking the public for all that its worth by literally hijacking the psychologically attractive veneer of being a “natural” source of wholesome products. Many nutritional supplement companies claim to do nothing but good and imply that they have an innate “healing” knowledge, a benign close to nature philosophy. This image dovetails nicely with much of the public attitude creating an excellent environment for these businesses to flourish.

Indeed, the US is ripe with expanding opportunity for “other ways” that are not “traditional” with respect to diet and health. A 1998 survey in the Journal of the American Medical Association found that the use of alternative medicine (alternative nutrition included) is most common among highly educated people between the ages of thirty-six and forty-nine having median incomes of over $50,000. It is easy to understand how the use of dietary supplements has become a billion dollar industry that continues to expand.

One, problem though, is that there is a huge rift between what is claimed by these companies and what the true nature of their products actually are. Dan Hurley in Natural Causes counts about 29,000 nutritional supplement products on the market. Of these, only two offer some promise of efficacy (omega-3 fatty acids and vitamin D) though in a more limited scope than advertised- with the caveat that the jury is still out on these and they can readily be found in a good diet.

Another problem is how do the testers do the testing? Not withstanding the well worn issues and discussion with current FDA standards and pharmaceutical drug testing, a system does exist and accountability plays a significant role in it. The nutritional supplement industry, on the other hand, has huge leeway and little constraint in the production and promotion of their products.

The National Center for Complementary and Alternative Medicine (NCCAM) is presently the NIH branch charged with funding research into the efficacy of alternative medicines including supplements. Having roots in the political arena, it has origins in senator Tom Harkins Pubic Law 102-170 which established an office to “investigate and validate…unconventional medical practices” and since has grown into a behemoth with a whopping 2007 budget of ~$120,000,000. Senator Harkin claimed to have been cured of severe allergies using bee pollen and nutritional treatments and became a powerful supporter (at the right time and place) of alternative medicine modalities. It comes as little surprise then that this politically born government supported center has a rather spotty track record for solid science based research and conclusions.

In 2001, Saul Green, PhD formerly part of research at the Memorial Sloan-Kettering Cancer Center in New York published the results of a detailed review of NCCAM studies. In it he notes:

“To my knowledge, and based on a review of abstracts published by the OAM/NCCAM, no report stated that a treatment did not work. In the past nine years, no negative result has been published, nor have any of the methods studied been shown to work to the satisfaction of the medical science community”

Hurley states; “In other words, none of the positive studies were big enough or well designed enough to prove that the supplements being studied truly worked. And on the flip side, when the studies failed to find the hoped for results, the NCCAM reports always stopped short of declaring the treatment to be of no value.”

Dr. Strauss, NCCAM director, as a result of growing pressure for proper science based studies, wrote in a 2005 budget document there needed to be giudlines; “...requiring newly funded researchers to provide evidence of the quality of their study materials, submit selected samples for independent testing, and justify proposed dosing.” In spite of this, hundreds of small studies with little plausible rational, or studying treatments that have already been demonstrated not to work, continue to be funded.

For the nearly one billion dollars earmarked for and spent by NCCAM since its dubious inception in 1991 there are some recent better quality studies that have been funded. Of these, three recent major studies related to dietary supplements completed between 2005 and 2006 (Echinacea, saw palmetto, and chondroitin and glucosamine) all concluded the supplements in question were ineffective.

These studies indicate that things indeed have improved somewhat and scientific objectivity may be increasing in some of the NCCAM studies. However, there still permeates in the NCCAM a “God of the gaps” perspective with respect to declaring a product or alternative modality ineffective.

There are other agencies looking into the safety and efficacy of dietary supplements outside of NCCAMs’ sphere of influence including scientists, consumer-protection groups, and other government agencies that have provided hundreds of well designed studies.

With this in mind Hurley asks a good question, “…after fifteen years and nearly a billion dollars of disappointment, the question is, why should the American taxpayer keep funding this beast (NCCAM), when other arms of the NIH are desperate for funds to study truly promising treatments for heart disease, stroke, diabetes, Alzheimer’s disease, and more?"

If the nutritional supplement industry continues to make their implicit health claims, they need to back them up by real efficacy and solid evidence. This is not entertainment; this is public health- these companies can not prosper by political maneuvering and skirting consumer protection policies.

Ref: Hurley, D. Natural Causes. Random House. New York. 2006

1 comment:

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