Jul 07 2011

Good Critique of DSHEA

I have been highly critical in this blog and SBM about the Dietary Supplement Health and Education Act of 1994 (DSHEA) – a legislative gift to the supplement industry mostly credited to senator Orrin Hatch. Hatch has a cozy relationship with the supplement industry, which is large in his state of Utah. The New York Times wrote a good piece about Hatch’s deep support for the supplement industry (in which I am quoted).

Now a commentary published in JAMA (the Journal of the American Medical Association) also give a broadside to DSHEA. Article author, Bryan Denham, focuses on the point that the strategy of the supplement industry has been to lobby for increased freedom, and this has been a successful strategy. Often this is framed as increased freedom of information or freedom for consumers – but really it’s just more freedom of the industry from regulation for product safety and the propriety of their health claims. For example, he writes:

In 2009, a US Government Accountability Office (GAO) report found that “consumers are not well-informed about the safety and efficacy of dietary supplements and have difficulty interpreting the labels on these products.”

DSHEA is largely premised on the concept of the “well-informed consumer.” Hatch often makes that point himself in interviewing, saying, in effect – we don’t need big government telling us what supplements we can take.

I acknowledge there is an ideological spectrum here. But let’s at least be honest about the facts. It is easy for the supplement industry to market products that have no health benefits, but make claims that strongly imply or even directly claim that they do. The vast majority of consumers to not have the level of scientific knowledge to parse these claims, and falsely depend upon the government to protect them from false claims or unsafe products. Most consumers do not realize that supplement claims are not reviewed prior to marketing. I have had this conversation with hundred of patients and colleagues – and almost none of them (outside my colleagues at SBM) were familiar with current regulations. All assumed a higher level of government oversight than is currently in place.

Denham also reports that the problems are far worse than even the misleading labels on supplements would indicate. The culture of the industry is one of making hyped health claims based upon no evidence, or at best flimsy or pre-clinical evidence. He cites a GAO investigation:

According to the GAO, more troubling than the contaminants was the dubious and potentially hazardous advice offered to investigators who had posed as elderly customers. The GAO gathered written materials from online retailers, observing claims of treating, preventing, and curing conditions such as diabetes, cancer, and cardiovascular disease. Among the more egregious marketing efforts were claims that garlic could be taken in place of high blood pressure medication and that ginkgo biloba could be used to treat Alzheimer disease, depression, and impotence.

What this indicates is that Hatch’s loophole has worked (for the industry). Allow them to make “structure function” claims about their products without oversight, or any burden of evidence. Structure function claims are claims about how the body functions, but cannot name specific diseases. That’s why so many supplements say they “boost the immune system” or “support cellular health” or similar claims – because they can. But these claims are just the foot in the door, a sly way to imply a disease claim. The evidence for this is when you catch supplement sellers talking to customers, they go right for the disease claims. Further – despite all the posturing about “complementary” or “integrative” medicine – they are often recommending supplements be used instead of proven therapies.

This is just one example of the overall bait-and-switch strategy of CAM that I have been writing about. To academics and regulators proponents talk “structure function” claims and other coy concepts such as patient-centered medicine, and of course this is all in addition to proven mainstream medicine. Unfortunately many naive academics buy it, and they in turn pass the deception on to journalists who interview them. But when you get in the trenches you see what is really going on – proponents are using fanciful and unproven therapies first line, criticizing science-based medicine, and making direct disease claims without proper evidence.

The bottom line is this – once you abandon good science as the primary method of determining which products and treatments are safe and effective, you open up a Pandora’s box of pseudoscience and fraud.

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