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Commercial deception: undeclared drugs in herbs and other dietary supplements

Back in February, an acupuncturist in Key West, Florida, was arrested on charges of using a physician’s credentials to obtain controlled substances and other prescription drugs.  While some of these drugs were for the individual’s personal use, the Key West Citizen reported from arrest records that the acupuncturist had obtained other drugs for her patients, including anxiolytics, a muscle relaxant, and sedative sleep aids.

While it is not clear if the individual in question specifically mixed those drugs with herbal or homeopathic remedies available at her practice, the demographics of her clientele are likely to be inconsistent with the use of prescription drugs.

Why do I propose this hypothesis and where would a practitioner get the idea to mix prescription drugs with herbal products to make them appear effective?

Why, the dietary supplement industry, of course.

In fact, adulterating commercial herbal products with prescription drugs is so common that the US FDA is keeping a running tally of actions against companies selling supplements containing “undeclared drugs”: the polite regulatory term for deceptive doping of a useless product with a real drug.

Most-common approaches have been to dope weight-loss supplements with sibutramine, a prescription amphetamine-like, serotonin/norepinephrine reuptake inhibitor sold in the US and Canada as Meridia.   The US FDA list on this class of deception has increased from 28 to 69 products since 22 Dec 2008.  Regular SBM readers may have heard, for example, of weight loss claims made for apple cider vinegar capsules.  You may be surprised to know that such a product might have efficacy – if it contains sibutramine – as the FDA found in 2007 for a product manufactured by Confidence, Inc.

Another common adulteration tactic is for erectile dysfunction supplement manufacturers to boost their products with prescription phosphodiesterase type 5 (PDE5) inhibitors such as sildenafil (Viagra) or related compounds.  So popular is this approach that the same manufacturer cited above for sibutramine-adulteration of apple cider vinegar products has also been found guilty of adding PDE5 inhibitors to their aptly named “Long Weekend” product.

At least their business model is consistent.

In fact, a recent FDA investigation of such supplements sold online revealed that up to one-third of products are so adulterated.

Most concerning is when these adulterants might interact with other medications a patient is taking (in the case of PDE5 inhibitors and antihypertensive vasodilators) or, worse, have inherent harmful effects.  There is at least one case in the literature where supplement doping has been associated with unusual cases of prostate cancer (Clin Cancer Res 2008:607-11).  In this case, the bodybuilding supplement Teston-6 was found to contain testosterone and other compounds more potent than testosterone in promoting prostate cancer cell growth in vitro.

As a natural products pharmacologist, I am all for researching botanical and non-botanical supplements that may intrinsically contain useful therapeutic molecules – that is the cornerstone of my field.  Indeed, some traditional herbal medicines have been used as sources for modern pharmaceuticals.

But to dope supplement products with effective drugs is to admit that one is selling garbage: a deceptive practice to prey upon those who choose to seek out “alternative” medical approaches and keep them coming back.  I wonder how many consumers of “green” or “alternative” products (paid for out-of-pocket, mind you) would be pleased to know that their apparent health benefits were due to prescription drugs present therein that could have been obtained in a consistent, reproducible dosage form for a small co-pay.

This practice also makes one wonder how many anecdotal cases of “success” with herbal products could be attributed to adulteration with prescription drugs.

For this reason, I recommend that grant reviewers and journal editors insist that any dietary supplement used in a clinical trial be subjected to extensive chemical analysis as a condition of funding or publication, respectively, including screening for pharmaceutical compounds capable of exerting the therapeutic effect under investigation.

Posted in: Health Fraud, Herbs & Supplements

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