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November 12, 2009
Over The Counter, Under The Radar
When I have a few spare minutes for surfing the web, I wouldn’t normally spend them looking at a website like Bodybuilding.com. But I was there, nonetheless, this afternoon. On the homepage I was greeted by a slideshow of before and after photos. One of the slides was of 55 year old, Ed, a roofing products salesmen from Vancouver, Washington. In his ‘before’ photo, Ed is pale and pudgy in his swimming trunks—almost unrecognizable in relation to the ‘after’ photo where Ed’s big ropey muscles ripple under over-tanned, paper-thin skin. In his bio, Ed says his goal is to reach three percent body fat. He says that his favorite supplements are ‘Elite Whey’ and ‘Instantized BCAA 5000’ (whatever that is).
Which was the point of my visit. On November 3, the Food and Drug Administration (FDA) recalled 65 products sold by Bodybuilding.com as dietary supplements. The FDA has found that some of the ingredients—Superdrol, Madol, Tren, Androstenedione, and Turinabol—should be classified as steroids. They carry the risk of acute liver damage, as well as ‘shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death’ (FDA 2009).
The recall elevates into public concern, the way in which dietary supplements are regulated in the US. Before 1994, the constituent ingredients of dietary supplements were treated as food additives, and manufacturers were required to prove their safety. But since the passage of the 1994 Dietary Supplement Health and Education Act, dietary supplements are immune from FDA approval, and assumed to be safe.
The act creates a backdoor through which manufacturers can slip badly labeled and contaminated supplement products onto the US market. Some of these contain undeclared and potentially dangerous active pharmaceutical ingredients such as amphetamines, diuretics, and steroids. To date, the FDA has uncovered around 140 contaminated products, and they suspect that around 50,000 unreported adverse events occur each year. While many of the contaminated products are manufactured overseas and sold on the internet, some of them have also made it onto retail shelves. Some manufacturers further attempt to avoid detection by replacing controlled active ingredients with chemical analogues that replicate the actions of the original compound. In addition to potential side effects, most of these analogues are yet to be clinically trialed for use in humans.
The public generally doesn’t understand that these substances may be putting them at serious risk. Surveys have revealed that the majority of people believe that dietary supplements are regulated by the government. The misunderstanding is not limited to the general population. A study involving 300 internal medicine trainees, found that one-third of them believed that dietary supplements require FDA approval (Cohen 2009).
I’ve certainly encountered issues in my practice where patients have misused dietary supplements—weight loss aides and bodybuilding products, in particular. In our society where there’s a pill to fix everything from erectile dysfunction to thinning eyelashes, it’s natural for people to self-medicate with an OTC remedy that promises to help them achieve their goals. The danger, however, is when people are led to believe that they’re taking natural, non-pharmaceutical products. These products don’t come with a prescription yet may contain prescription components, so the opportunity for misuse is rife. And given that dietary supplements fall outside of the FDA’s jurisdiction, there’s also little information about potential interactions between pharmaceutical products and dietary supplements.
Writing in the New England Journal of Medicine, Pieter Cohen (2009) encourages physicians to be mindful that the ingredient list of a dietary supplement may not include all of the active components. He encourages doctors to report any suspected adverse events to the FDA (www.fda.gov/MedWatch/report.htm), even where the ingredient list suggests otherwise. Given that 114 million Americans (around half of all adults) consume dietary supplements, the public risk is significant and doctors are very likely, at some point in their practice, to encounter adverse events caused by a dietary supplement.
It’s surprising that it’s taken the FDA this long to clamp down on the steroids that were being sold as ingredients in some of the dietary supplements available on Bodybuilding.com. During my cursory exploration of the website, I came across a chat forum titled Superdrol for Dummies in which a bodybuilder recommends a dosing regime for the steroid, along with Clomiphene, and Tamoxifen. At one point, he writes, “Clomid has worked excellently for me... It takes care of any testicular atrophy that may arise on [the] cycle” and “…make sure you give a full two month gap between cycles. After all you've got just one liver to use for a lifetime”. ‘Superdrol for Dummies’, indeed!
Robin Stone, M.D.
Insight Psychiatry
13123 Rosedale Hill Ave.
Huntersville, NC 28078
704-948-3810
Further reading:
Cohen, P 2009 American roulette—contaminated dietary supplements, New England Journal of Medicine, Oct 7.
United States Food & Drug Administration (FDA) | Safety | Recalls | BODYBUILDING.COM Is Conducting a Voluntary Nationwide and International Recall of 65 Dietary Supplements That May Contain Steroids; November 3, 2009.
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