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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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9 thoughts on “Commercial deception: undeclared drugs in herbs and other dietary supplements

  1. David Gorski says:

    Excellent points all. Then there’s all the mercury and heavy metals in various herbal remedies from China. I forget again, why is it supposedly better to use unpurified plants rather than purified natural products as pharmaceuticals?

  2. Mark Crislip says:

    to plug myself (painful), the last third of quackcast 31 covers this as well.

  3. HCN says:

    Dr. Crislip, you can leave links:
    http://www.quackcast.com/page2/page2.html

    I shall download your latest. I very much enjoyed the one before, #30 “Lets Kill The Children or A Defense of Vaccines Why vaccines, to quote Mr. Pooh, “Are a Good Thing.” ” (I hate iTunes, I purged my computer of every last trace of it, I am good with clicking on the other button to save the target to my computer!).

    I am sorry you had to be dragged in to watch the Oscars. I have not bothered with them in years. Though I did rush upstairs to my room after my mother’s birthday celebration to see Charles Chaplin receive his special Oscar many long years ago when I was in high school. I thought that was special.

    By the way, if you are up here sometime I will endeavor to come to your talk (Harriet Hall arranges the speakers for some of the talks here, which is how I was able to meet Bob Park — I assume you saw him in Portland the day before we saw him up here!).

  4. In battles that I’ve had with CAM-pushers in real life and in places like Wikipedia, one of the arguments, which you’ve all heard time and again, is that Big Pharma is somehow unethically withholding information that (fill in the blank, but some CAM herb, potion, ointment or technique) actually works and is better for the patient.

    When I read this kind of stuff (this website is slowly pushing me to insanity), it confirms what I’ve said for years. Big Vitamin (I haven’t come up with a good solid pejorative term for CAM) is less ethical, more profit oriented, and withholds more data than even the worst pharmaceutical company.

    I wonder what Tom Harkin will think of this quote:

    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.

  5. wertys says:

    There was a scandal in Melbourne, Australia a few years ago where an unscrupulous TCM practitioner was importing prednisone and chloramphenicol from overseas and adulterating his ‘asthma cure’ with it. Fortunately an asute local GP picked up that several of his Asian patients with asthma were looking rather cushingoid despite not being on inhaled corticosteroids ! The guy didn’t even go to jail, as there was no relevant severe offence to charge him with.

    This led to the creation of a state body to regulate TCM scammers, though this is rather like letting the lunatics run the asylum as my not-so-PC father used to say. There has been some improvement since, but the latest edition of the electronic newsletter from the CMRB says in part, regarding breaches of the advertising regulations..

    “It is most dissatisfying to the Board that its repeated reminders to the profession have been somewhat unsuccessful and it has become necessary to prosecute registered practitioners for advertising offences. After an initial period of education, guidance and individual and general warnings, continuing to warn and warn and warn cannot be justified.”

    link is here
    http://www.cmrb.vic.gov.au/current-news/newsletters/dec2008newsletter.pdf

    And this is the situation in one of the most highly regulated state legislatures in the world for TCM ! One shudders to think what might be under the rock in less ‘policed’ environments..

    Interestingly, the majority of lawsuits this body has brought have been against individuals falsely using protected titles under the Board’s jurisdiction, ie protecting its turf rather than weeding out poor practitioners.

  6. Eric Jackson says:

    Some of the reports that show up on Medwatch are truly horrific. One of my favorites:

    http://www.fda.gov/oc/po/firmrecalls/herbalscience04_08.html

    An ‘Herbal product’ contaminated with human placenta of all things.

    Based on a quick scan through the last few years of MedWatch reports, the overwhelming number of adulterants seem to be either ephedra, viagra (or analogues), sympathetomimetic stimulants (particularly in weight loss products), the occasional antidepressant and statin. Dozens of these are caught per year in an industry that has virtually no oversight, minimal legal penalties and no safety testing. Until very recently when the DSHEA ‘good manufacturing practices’ were finally implemented after nearly a decade of fighting, the manufacturers weren’t required to maintain basic sanitary standards. One report I read many years ago, I believe in the SF Chronicle stated that the FDA had only eight people employed in regulating the entire multi-billion dollar supplement industry, I can’t confirm the veracity of that, but even the implication is shocking.

    These substances are not accidental contaminants. They are not things that can be introduced from a bad batch of feedstock, or equipment failures in the manufacturing process. Viagra does not end up in a ‘miracle all natural herbal ED supplement’ by accident.

    This of course, isn’t even touching on the issue of heavy metal contamination in products marketed a Ayurvedic medicine.

    Based entirely on my opinion, what I’ve read, and heard from various professors in the field, in the past decade or so most of the contemptible behavior out of pharmaceutical companies has been in the realm of evergreening and patent-gouging, inflating prices. More legal wrangling to keep the prices high and replacing acceptable drugs with ones that offer incredibly minor, debatable improvements. The replacement of Venlafaxine with O-Desmethylvenlafaxine (Pristiq) is a shining example of this. Much of this seems to be the responsibility of the lawsuits against Parke-Davis over its totally irresponsible and unethical marketing of Neurontin as a panacea in a variety of fields. The subsequent olanzapine lawsuits drove this home further.

    The supplement industry on the hand seems to be acting far, far worse. A mixture of snake oil, deceptive and exploitive marketing, coupled with a complete lack of oversight that allows faulty, contaminated and dangerous products on the market. The almost nonexistent ability of the government to enforce the almost nonexistent legal remedies allow them to almost completely ignore the restrictions that are in place.

    In other news, this: http://www.juiceitup.com/wheatgrass.html is displayed prominently in the local franchise of the same name near the university I attend. Rather sickening to be honest.

  7. phiend says:

    I had to pause when i read this
    “a product manufactured by Confidence, Inc.”
    Really, CONfidence Inc. What was This Is a Scam, LLC taken.

  8. Calli Arcale says:

    Oooh, good point, phiend!

    “Con” is, of course, short for “confidence trick”, because a successful con is all about gaining the *confidence* of your mark. That’s something that the herbal medicine purveyors are all too good at doing.

    I watched the Dr Who serial “Ribos Operation” last night. Great story, revolving around a pair of confidence tricksters who dupe extremely wealthy people into buying planets that they don’t actually own. It includes this lovely interchange, relevant to this discussion:

    Doctor: Scringestone, an ancient mine? What, are people still falling for that old guff, I mean, are they?
    Romana: What, you mean you didn’t believe him?
    Doctor: No.
    Romana: But he had such an open honest face!
    Doctor: Romana, you can hardly be a decent crook with a dishonest face, can you?

    The main problem is that people tend to assume that everybody else is basically honest. And most of them are. The remainder are busy fleecing all the honest people.

  9. Kneil says:

    I think the scariest scenario is someone who’s MD has ruled out certain drugs for them because of other drugs, ailments or allergies (i.e. treating the whole person) might go looking for a natural alternative. And that “natural” alternative could end up being a random dose of a randomly chosen drug from the family of drugs they were supposed to avoid.

    Sound like it might be safer for the MD to say “Okay, I’ll write you a ‘script for Viagra, but since you are also on nitro you should only take it within a few blocks of a large hospital.”

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