dietary supplement
Photo Credit: Photl

We have written about supplements on this site many times and we will keep on doing so as long as this very profitable, but woefully under-regulated industry continues to sell unsafe products to the unsuspecting public.

 

Supplements, hepatitis and liver failure

In an article in New England Journal of Medicine titled, “Hazards of Hindsight—Monitoring the Safety of Nutritional Supplements,” Dr. Pieter Cohen highlights a cluster of cases of severe hepatitis and liver failure that led to 47 hospitalizations, three liver transplantations, and one death due to the ingestion of the dietary supplement OxyElite Pro. Because of the Dietary Supplement Health and Education Act of 1994, there is no requirement for FDA premarket approval.

These drugs are assumed to be safe until, well, they aren’t. The only thing the FDA can do is to identify and prohibit the sale of dangerous supplements after they have killed and injured enough people to get their attention. What a sad state of affairs.

According to the article,

“more than 500 supplements have already been found to be adulterated with pharmaceuticals or pharmaceutical analogues, including new stimulants, novel anabolic steroids, unapproved antidepressants, banned weight-loss medications and untested sildenafil [Viagra] analogues.”

Really! No wonder people love them.

In addition, people can have bad reactions to legal ingredients in some dietary supplements. For example, ingestion of Ginkgo can result in bleeding; comfrey, fo-ti, germander, and usnic acid have toxic effects on the liver; and Vitamin A has been associated with osteoporotic fractures.

But the real danger, I think, is when consumers and doctors don’t know what is in the supplements. That is why Dr. Cohen proposes a “supplement response team” that could be alerted immediately after an adverse event is reported. The team, made up of clinicians, toxicologists, pharmacologists, and chemists, could then offer advice to treating clinicians and provide detailed reports to the FDA. That is fine, good in fact. But I don’t think it goes far enough.

 

The Dietary Supplement Labeling Act

Dick Durbin, Senior Senator, IL (D)
Dick Durbin, Senior Senator, IL (D)

We need repeal or major reform of the law the supplement manufacturers have been hiding behind (thanks to Orrin Hatch). There is a bill currently being reviewed in committee, the Dietary Supplement Labeling Act, that is sponsored by Dick Durbin (D-IL) and Richard Blumenthal (D-CT). The bill would “require supplement manufacturers to register their products with the FDA and to provide more safety information, such as information about known adverse effects,to consumers.” It is currently being reviewed by committee. [Update: This bill did indeed fail to be enacted by Congress—no surprise given the powerful and well-monied forces against regulation of the industry.]

The problem is this bill, if passed into law, would only ensure “that vitamins, minerals, botanicals, probiotics, and other supplement ingredients are accurately labeled, but it would not improve the FDA’s ability to detect and remove dangerous supplements from store shelves. And by the way, the analysis on GovTrack.us is that the bill has “0% chance of being enacted.”

So, I have an idea. If we can’t regulate these drugs in a way that improves consumer safety, what if we simply let payers sue the manufacturers to recover the cost of providing care for illnesses caused by their products? That’s my two cents….what’s yours?


Featured photo credit: Photl.com

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