Terra Sigillata

An interesting question arose the other day when we discussed the Key West acupuncturist who was diverting prescription drugs for personal use as well as in her practice. While we are not certain that the defendant put the cited muscle relaxants and anxiolytics in remedies doled out at her practice, we doubt that the demographic she targeted would be too impressed if she were to hand out prescription drugs.

This scenario led our scientific and blogging colleague, DrugMonkey, to ask how common it might be for alternative practitioners to dope their herbs with prescription drugs exhibiting known efficacy. He also notes how disingenuous this practice might be in that the alternative practitioner is admitting in doing so that their herbs and elixirs have no efficacy on their own.

I can’t speak to trends among individual practitioners but this practice takes a page from the big boys: the dietary supplement industry.

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.

We’ve spoken about these cases several times before [1, 2, 3, 4, 5, 6]. 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. For example, we get a large number of hits from readers searching for apple cider vinegar capsules and whether they can help one lose weight – well, yes they can, if they contain sibutramine, of course.

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 “Long Weekend” product. At least their business model is consistent, eh? A recent FDA investigation of such supplements sold online revealed that up to one-third of products are so adulterated.

This may all seem like fun and games but 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 crap: a deceptive practice to prey upon those who choose to seek out “alternative” medical approaches.

This practice makes one wonder how many anecdotal cases of “success” with herbal products is due to adulteration with prescription drugs.

Comments

  1. #1 leigh
    April 13, 2009

    also: what if a patient is seeking alternatives due to a known allergy/intolerance to the prescription drug? oops.

  2. #2 Abel Pharmboy
    April 13, 2009

    leigh, that is exactly the concern with the the PDE5 adulterations: the potential for adverse reactions if a person is also taking nitrates or other vasodilators for hypertension or angina.

  3. #3 Carman
    April 13, 2009

    hear, hear! it’s so frustrating to watch a potential wellspring of new therapies continually undermined by wildly irresponsible “practitioners”

  4. #4 wamba
    April 13, 2009
  5. #5 The Perky Skeptic
    April 13, 2009

    “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.”

    OMG! You’re what I wanted to be when I grew up, before I diverted into plant physiology, then to ecology, and eventually to illustration, LOL!

  6. #6 Joe
    April 13, 2009

    Further to leigh-who-is-too-tired-to-use-the-shift-key (but posts a lot, nonetheless). OTC products are also bad for some people (e.g., aspirin can enhance bleeding problems, acetaminophen should not be taken by people with liver problems) so the potential for trouble is not limited to prescription drugs.

  7. #7 leigh
    April 13, 2009

    dear joe,
    i couldn’t care less what you think of my shift key use or my commenting patterns. thanks for your concern though. oh, and i feel quite rested today.

    here’s the difference between undisclosed drugs in supplements and otc drugs- in one case you do know what you’re taking. it’s right there on the label, with appropriate warnings and etc available if you care to read them. in the other, not so much.

    for those who are seeking “alternative” therapies to the prescription kind, thinking that they are free of the drugs they cannot tolerate for whatever reason, it’s probably a fairly unpleasant discovery when they learn these supplements exacerbate the same symptoms that the prescription drugs did. because they contain the same active ingredient, but didn’t say so on the label. i imagine the medical expenses from this might add up quickly…

  8. #8 Joe
    April 13, 2009

    I am sorry, I was not clear: when OTC drugs are surrepticiously used in “supplements” they are as dangerous as prescription drugs hidden in “supplements.”

  9. #9 Abel Pharmboy
    April 13, 2009

    We’re cool; I think that Joe and leigh are on the same page. This discussion raises another issue: OTC drugs have their own dangers, especially because they are perceived by the public as being very safe. Lots of good lessons here – great discussion, y’all.

  10. #10 Matt
    April 13, 2009

    Thanks for posting that. I had not heard of the practice until now. I’m very involved in the natural products world. Until very recently I worked for an outfit that was searching for antibiotics from terrestrial plants.

    Having practioners like this fouls the water for legitimate research.

  11. #11 llewelly
    April 13, 2009

    Randi does a stunt in which he eats a whole bottle of homeopathic sleeping pills.
    I hope he keeps a close eye on the manufacturer, to ensure something active isn’t being slipped into his pills.

  12. #12 Becks
    April 14, 2009

    Unless you have been living in a hole in the ground you know there are prescription drugs that make men stand to attention. But the downside is sex by arrangement accompanied by the fear of -will it work?
    Well now there really does appear to be a genuine alternative in Butea Superba. The clinical trials for this herb/plant are proving successful for over 84% of the men that take Butea. Considering prescription drugs do not give that high level of success, in fact some clinical trials for leading blue prescription pills show success for just 50% of those taking part. So, to recap, Butea gives a much better result and is not a drug, which means suffering none of the side effects associated with prescription erection pills. Plus as you take Butea as a supplement the men taking part in the trials found that given the right stimulation they could get up and stay up at anytime during the day or night.
    As Butea works in exactly the same way as prescription blue pills by allowing more blood to flow freely into your trouser truncheon then delaying the speed at which in flows back out. You will experience firmer erections more often and those erections will last longer. If you want the science behind Butea then read the clinical trials see http://www.healthyed.co.uk/butea-clinical-trial.php. If you want to better understand the bodies response to Butea go to http://www.healthyed.co.uk/how-it-works.php.
    Those who have already discovered Butea Superba is available on the Internet may have bought from obscure sellers in Thailand or elsewhere in the Far East. The good news is that it is now professionally produced and packaged by a company based much nearer home. The brand name under which Butea is made available to impotence sufferers is HealthyED and whats more it is cheaper than if you buy it from half way around the world. Check out the best impotence solution on the market today at http://www.healthyed.co.uk

  13. #13 Pieter B
    April 14, 2009

    I used to work at a well-known teaching hospital, and the head of hepatology had a shelf on which many bottles of “traditional herbal medicines” were displayed. When I asked why, he told me that they all had been the cause of liver damage in patients he had seen, and that in most cases it was due to what are now called “undeclared drugs.” This was close to 20 years ago; it’s not a new phenomenon at all.

  14. #14 leigh
    April 14, 2009

    @Joe-

    in that case, i do agree with you.

  15. #15 Joe
    April 14, 2009

    @leigh-

    You capitalized my name! This could be the beginning of a long friendship.

  16. #16 leigh
    April 15, 2009

    that’s all it took, eh? :)

  17. #17 Joe
    April 16, 2009

    that’s all it took, eh? :) Posted by: leigh | April 15, 2009 4:27 PM

    It could take a bit more- I still have trouble with long tracts lacking capitalization. The capitals (signifying new ideas, aka sentences) and organize your text. Just as new paragraphs suggest new arguments.

  18. #18 leigh
    April 17, 2009

    in this case you’ll have to accept me as i am… intentional lack of caps is part of my online persona.

  19. #19 Joe
    April 17, 2009

    leigh

    Many youngsters adopt such affectations. Do you realize that you are not unique, or (even) original? Long tracts without capitalization are difficult to read. If you want to be read, …

  20. #20 Abel Pharmboy
    April 17, 2009

    leigh and Joe, I suspect that you would both have quite a bit in common despite the difference in time spectrum. I have had the pleasure of knowing leigh in person (and she introduces herself with a lowercase name) and Joe is a long-time commenter with whom I share much in common. We are all birds of a feather despite our generational differences.

  21. #21 Joe
    April 19, 2009

    Here is a 2007 article in Medscape http://www.medscape.com/viewarticle/566897_1 (if they require registration, it is free).

  22. #22 John Bonanno
    April 21, 2009

    It seems that what should be vigorously regulated is the illegal use of prescription drugs, not the safe and ancient herbal supplements that are being appropriated as their delivery systems.

  23. #23 Joe
    April 21, 2009

    Mr. Bonanno,

    Safe and ancient herbs such as sassafras? Wait, no, that is carcinogenic. Aristolochia? No, that is nephrotoxic and carcinogenic. Maybe comfrey, no- hepatotoxic. Perhaps pokeweed … perhaps not, it is highly toxic both orally and topically. The United States Herb Trade Association recommends that pokeweed not be sold.

    The myth of the general, nontoxicity of herbs comes from lack of study and surveillance. Tobacco can’t cause cancer, look how many people use for long periods of time.

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