Beware of Big Nutra:
Imagine if Big Pharma could market a product before they had approval for its use. In fact, imagine if Big Pharma didn’t have to get permission from the FDA at all. Could you imagine if a company could market something for your health, with no evidence it works, buy advertising, then get the government to study it? Then, while it is out there in the public being used for some ailment, if there are people getting sick from it there is no way to monitor that. We have that in this country- its name is Big Nutra.
Big Nutra is short for the nutraceutical companies that make supplements, foods, vitamins, offer “prayer,” devices- and they are not regulated by any agency. Big Nutra is a 34 billion dollar industry. Here is how Big Nutra works: Make a claim, market a product, then sometimes the National Center for Complementary and Alternative Medicine will fund for that to be tested. This defies science.
Science is based on a method where you test a hypothesis. Once the hypothesis is tested you can make a claim.
The pharmaceutical industry is mandated to follow this model. They must first test their drug or device, and once the drug has passed (a) safety and toxicity (b) efficacy (meaning it is effective) then and only then can the industry apply to the FDA to market the drug. The FDA has very clear rules about how you market drugs and devices, what claims you can make about the product and any disease it treats. In addition the FDA develops a reporting mechanism to serve as a warning if there are complications from that product.
Contrast this with the nutraceutical industry (the non-regulated, no oversight, sell any vitamin or supplement). They are free to make a claim without any supporting evidence. Then Big Nutra market their pill, or device, or treatment as far and wide as they can afford. This marketing builds up support for their claim (usually it is a natural product from Tibet, and etc). Once it has built up the steam then sometimes a researcher will apply to the NCCAM to fund study.
Most of the NCCAM studies have found no efficacy to the alternative and complementary medicine supplements, therapies, devices, or prayers. Does this lead to less people trying the product? No. As Paul Offit pointed out, in spite of studies showing that echinacea does not treat cold symptoms it still has sales exceeding $300 million dollars per year. In any golf shop you will see the bracelets some golfers wear, even though they have been shown to have no effect on performance, and in spite of one company being told to refund all who ever purchased such a bracelet. Still, those, or versions of those products are marketed. In spite of well studied evidence that prayer does nothing for sick people, people continue to donate to churches so their loved ones could be remembered in the prayers of their pastor, or purchase prayer cloths, or icons in an effort to “heal” themselves or their loved one.
Backwards. If a claim made by a pharmaceutical drug or device was found to not be false (a) It could not be marketed with that claim and (b) if it had no other use would be pulled from the market. But if a claim is not supported from an alternative treatment there is no mechanism to pull the treatment from the market, nor is there a mechanism to keep them from making their claims of health.
The 1994 Dietary Supplement and Health Education Act allowed Big Nutra to be free of the regulations of the FDA. Prior to that, in 1992, Congress created the National Center for Complementary and Alternative medicine to “to explore complementary and alternative healing practices in the context of rigorous science.”
Consumers have a latent expectation that the government watches out for them. It is time that the 1994 Dietary Supplement act be repealed and Big Nutra come under the umbrella of the FDA so that products are tested before the claims are made, so that a system would be in place to monitor for adverse events, and a system to remove from the market those products that are not effective.
Imagine if we lived in a world of science – where the claims tested, and found false, could not longer be advertised. It would mean the end of a 34 billion dollar industry in complementary medicine – and as for churches and those who send out prayer cloths for cash – well, that billion dollar enterprise would be shut down also.
Dr. Terry Simpson
Dr. Terry Simpson received his undergraduate and graduate degrees from the University of Chicago where he spent several years in the Kovler Viral Oncology laboratories doing genetic engineering. He found he liked people more than petri dishes, and went to medical school. Dr. Simpson, a weight loss surgeon is an advocate of culinary medicine. The first surgeon to become certified in Culinary Medicine, he believes teaching people to improve their health through their food and in their kitchen. On the other side of the world, he has been a leading advocate of changing health care to make it more "relationship based," and his efforts awarded his team the Malcolm Baldrige award for healthcare in 2011 for the NUKA system of care in Alaska and in 2013 Dr Simpson won the National Indian Health Board Area Impact Award. A frequent contributor to media outlets discussing health related topics and advances in medicine, he is also a proud dad, husband, author, cook, and surgeon “in that order.” For media inquiries, please visit www.terrysimpson.com.