Danger from Dietary Supplements: The Strange Tale of Hydroxycut

Two years ago the then-best selling weight loss supplement Hydroxycut was pulled from the market after being linked to 23 cases of liver damage and one death. While the recall was voluntary on the part of the manufacturer, the Food and Drug Administration (FDA) issued consumer and clinician warnings, and you might think the story would end there. But it doesn’t.

The active ingredients suspected of causing harm included an extract of the Garcinia cambogia fruit, called hydroxycitric acid (in a proprietary formula called SuperCitrimax), green tea, and chromium. Were those substances really effective, and did they really cause the harm? We don’t know for sure. The few studies of hydroxycitric acid in humans that have been published tend to be very small, of shirt duration, and many of the positive studies did not disclose financial conflicts of interest. The manufacturer never-the-less cited those studies in advertisements for their products, making it seem as though their product was clinically tested. After the recall, Hydroxycut returned to the market, with those suspected ingredients removed from its primary formulation.

Amazingly, you can still find products that contain that triad of ingredients, including a sub-formulation of Hydroxycut, for sale on the internet. What was once dangerous enough to be withdrawn by the manufacturer has quietly returned to the market now that the fuss has died down. Perhaps this is an argument for ingredient-based regulation efforts, rather than just product based ones? That is, after all, the approach that finally removed ephedra from the market.

The new formulation of Hydroxycut contains Cissus quadrangularis. What exactly is that, and does it work? No clue (about whether it works). It’s a botanical extract, but evidence about its safety and effectiveness is hard to pin down. To begin with there are very few studies of the substance in humans. Those that were conducted were very small and only lasted for a few weeks. On closer scrutiny, many of the human trials that are supportive of the substances effectiveness were conducted by researchers with financial relationships to the manufacturer (in some cases they were patent holders for gimmicky supplements containing the substance under study). These relationships were not disclosed in many of their published studies. Hmmm, sounds familiar.

Interestingly enough, even with the original formulation of Hydroxycut no longer being widely marketed, case reports continue to be published, including in Medical Journal of Australia, and the Hawaii Medical Journal.

So why should we care about any of this we don’t use this particular brand of supplement? Several reasons, including:

-Dietary supplements are often considered “natural and therefore safe,” even though their labels often claim, and their ingredients often provide, potent pharmacological effects.

-Since they do not undergo anywhere near the pre-market regulatory scrutiny of pharmaceuticals, we have no way of knowing if they are safe and effective before they go to market.

-Post-market regulation is so lax that only an estimated 1% of adverse events are ever reported to FDA. This means the 23 reported cases might actually reflect something like 2300 cases of liver damage.

-When industry-related researchers publish findings that are strangely supportive of products that they stand to earn money from, and they fail to disclose their conflicts of interest, we should all be concerned. The scientific evidence-base isn’t perfect, but it’s the closest thing we have to objective truth about what works and what doesn’t in health. If industry is subverting this objectivity, we all stand to lose.

While many people like to scowl at the seemingly poor job that the FDA does in keeping the supplement-taking public safe, its important to remember that they are limited by the enforcement powers granted them by congress, and hamstrung by underfunding. The result is a very short-staffed agency with limited powers and an almost unenforceable mandate to keep the public safe.

That’s another reason why its unfortunate that manufacturers of dietary supplements appear to be willing to profit with potentially dangerous products of dubious effectiveness.

Finally, while one might assume that engaged and educated consumers might also be an answer, a new study found that even among doctors, there’s appears to be a lot of misconceptions about supplement safety and effectiveness: 20% of doctors surveyed in a new study reported using botanical supplements, with green tea being the most commonly taken. There just isn’t enough evidence supporting safe effective use of that many botanicals to suggest that all those doctors are taking those substances for evidenced-based reasons.

(Ironically, the discussion above addresses so-called "legitimate" products, not those that are intentionally tainted. The dietary supplement marketplace is so filled with fraud that the FDA recently released a consumer warning about them.)
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