Dietary Supplements: Ethical Considerations

by Kacper Niburski 

If you ever took supplements and didn’t feel any better, it’s probably because you didn’t take any in the first place. Recently, The New York Times reported that four out of five of the top-selling herbal supplements at four national retailers — GNC, Target, Walgreens and Walmart — did not contain the ingredients listed.1 St. John’s wort, for example, did not contain any St. John’s wort, but instead consisted of garlic, rice, and “a tropical root crop.” Garlic, on the other hand, did not contain any garlic. Perhaps the supplement provider can add some St. John’s wort to their garlic capsules as a means of ensuring quality control.

This isn’t the first time supplements have been revealed as missing key ingredients. In 2013, it was found using DNA fingerprinting that 59% of supposedly natural products tested contained DNA barcodes from plant species not mentioned on their labels.2 Worse, thirty out of the forty-four of the products substituted their labeled ingredients with other, cheaper materials.

These results come as increasing number of Americans use such “natural” treatments daily.3 Names once so foreign — ginkgo biloba, echinacea, Saw palmetto — that gesundheit seemed in order after enunciation have now become commonplace. The industry generates 25 billion dollar in sales annually.4 While money doesn’t grow on trees, it may very well be found in those capsules.

Mislabeling and missing active ingredients raise bioethical concerns. There’s a lot of low hanging ethical fruit. Forget that such complementary and alternative medicine (CAM) lacks the long-term rigor of scientific study, that the therapeutic effect on particular populations such as lactating woman or children are not known, that the claims of efficacy remain largely unsubstantiated save for the occasional hearsay, and that many of the CAM providers lack significant medical training.5,6 Forget that even if there is a causal link between one natural product and the abatement of disease, these macromolecules are often isolated in pharmaceuticals and modified for maximum potency.7 Forget, too, that the stores of these compounds are at best heterogeneous due to variability in temperature and growing conditions,8 that the batches will inevitably by inconsistent, and that there is no formal standardization process in the US.9 These are branching issues. They are not the root worry. Rather, the supplement industry’s unsupported health claims are the real and serious worry.

With adulterants and immense variability among samples, any claim to cure or alleviate conditions is suspect, when even supported through a study or two. (For example: cisapride and probiotics have shown some benefits in gastrointestinal motility.10) As a result, doctors cannot prescribe these alternatives. The risk of volatility and of not getting a compound with a known physiological cause-and-effect is too high. So too is the chance of harm. What of possible allergic reactions to or drug interactions with undisclosed ingredients? Allowing such substandard care is nothing short of hokum.

This is not to discount the noted placebo effect of such treatments. Nor is it meant to diminish the perceived exercise of patient autonomy supplementation may promote. Complements to traditional healthcare increase the appearance of more choice freedom of decision making. This is centrally an argument for the democratization of medicine. If dietary supplements were pure, tested, and well-studied, it’s reasonable to say that such choices would be more than beneficial. They’d be necessary.

But this is not the case. Without the most updated information, without the guarantee of purity, and without the wide support of those sworn to provide health— doctors, nurses, and health service practitioners —CAM is grasping at straws at best. And hey, straw may already be in one’s multi-vitamin.

Such concern over honesty in supplement labeling and effectiveness goes beyond mere ethical squabbling. Ethics are a reflection of what ought to be whereas law is a mirror of what is. Currently, there isn’t. Legal regulation surrounding supplements is as unsubstantial as the supplements themselves: they’re hollow, useless, and do nothing at all.

Senator Orrin Hatch is almost singularly to blame for the lack of regulatory oversight. The Food and Drug Administration is legally empowered to regulate pharmaceuticals. Supplements, however, are different. In 1994 Senator Hatch cooked up the Dietary Supplement Health and Education Act which has since prevented any form of standardization or check-ins by the Federal or state governments 1,2 With corporate funds supporting his campaigns, Senator Hatch squashes legislation that gets in the way the private companies’ interests. This leaves a wild-wild west scenario where the snake-oil sellers are dressed in tuxedos instead of raggedy garb, and they sell dietary capsules and vitamin panaceas.

It’s important to note this discrepancy between the ethics and legal practice for without statutes, ethics is insufficient. A long term legal solution is required. Recalling the defunct products is the first step. The next is moving away from the chemical-madness of the mislabelled natural craze. Secondary measures are too dangerous because as it stands, swallowing a pill doesn’t waste away one’s weighty worries, let alone one’s waistline.

 

References:

  1. O’Connor, A. New York Attorney General Targets Supplements at Major Retailers. The New York Times. February 2015, < http://well.blogs.nytimes.com/2015/02/03/new-york-attorney-general-targets-supplements-at-major-retailers/?_r=1>.
  2. O’Connor, A. Health Supplements are Often Not What They Seem. The New York Times. May 2013, < http://www.nytimes.com/2013/11/05/science/herbal-supplements-are-often-not-what-they-seem.html>.
  3. Market Watch. June 2013, < http://www.marketwatch.com/story/americas-take-on-vitamins-survey-reveals-vitamin-intake-is-on-the-rise-but-healthy-lifestyle-habits-lag-behind-2013-06-26>.
  4. Maynard, A. Are We Safe From Congress? Politics USA. November 2013, < http://www.politicususa.com/2013/11/10/safe-congress-senator-orrin-hatch-politics-vitamins.html>.
  5. Newmaster, S et al. DNA Barcodings Detects Contamination and Substitution in North American Herbal Products. BMC Medicine. 11: 222.
  6. Brulotte, J. Vohra, S. Epidemiology of NHP-drug Interactions: Identification and Evaluation.Current Drug Metabolism. 2008;9(10):1049–1054.
  7. Institute of Medicine (U.S.) Committee on the Use of Complementary and Alternative Medicine by the American Public Board on Health Promotion and Disease Prevention. Complementary and Alternative Medicine in the United States. Washington, DC: National Academies Press; 2005.
  8. Ernst, E. Cohen, M. Stone, J. Ethical Problems Arising in Evidence based Complementary and Alternative Medicine. Journal of Medical Ethics. 2004. 30, 156-159.
  9. Ernst, E. The Efficacy of Herbal Medicine:An Overview.Fundamental Clinical Pharmacology. 2005;19(4):405–409.
  10. Muller-Lissner, S.A. Treatment of Chronic Constipation with Cisapride and Placebo.1987;28(8):1033–1038.

One comment

  1. Great post! It’s so well-written that the structure elucidates issues in some other industries, as well. For example, the parallels between the supplement industry and mental health industry are striking. Many of the terms in the sentences here about the supplement industry can be substituted with their psychotherapy counterparts to illustrate the parallels:

    “Mislabeling and [failing to disclose mechanisms of action] raise bioethical concerns. There’s a lot of low hanging ethical fruit. Forget that such [psychotherapies] lack the long-term rigor of scientific study, that the therapeutic effect on particular populations are not known, that the claims of efficacy remain largely unsubstantiated save for the occasional hearsay, and that many of the [psychotherapy] providers lack significant medical training. Forget that even if there is a causal link between [talk therapy] and the abatement of disease . . . Forget, too, that [these therapies] are at best heterogeneous due to variability in [therapist characteristics and biases], that the [therapies] will inevitably by inconsistent, and that there is no formal standardization process in the US.
    These are branching issues. They are not the root worry. Rather, the [psychotherapy] industry’s unsupported health claims are the real and serious worry.

    With [biases] and immense variability among [therapists], any claim to cure or alleviate conditions is suspect, when even supported through a study or two. As a result, doctors cannot prescribe these [therapies]. The risk of volatility and of not getting a [therapy] with a known physiological [or psychological] cause-and-effect is too high. So too is the chance of harm. What of possible [depressive or anxious or other negative] reactions or [suggestible memories] from [therapists] with undisclosed [biases, beliefs, or intentions]? Allowing such substandard care is nothing short of hokum.

    This is not to discount the noted placebo effect of such treatments. Nor is it meant to diminish the perceived exercise of patient autonomy [psychotherapy] may promote. Complements to traditional healthcare increase the appearance of more choice freedom of decision making. This is centrally an argument for the democratization of medicine. If [psychotherapies] were [safe, efficacious], tested, and well-studied, it’s reasonable to say that such choices would be more than beneficial. They’d be necessary.

    But this is not the case. Without the most updated information, without the guarantee of [safety or efficacy], and without [evidence-based standards, effective regulatory oversight or discipline], [psychotherapy] is grasping at straws at best.

    Such concern over honesty in [psychotheapy] labeling and effectiveness goes beyond mere ethical squabbling. Ethics are a reflection of what ought to be whereas law is a mirror of what is. Currently, there isn’t. Legal regulation surrounding [psychotherapy practice] is as unsubstantial as the [psychotherapies] themselves: they’re hollow, useless, and do nothing at all.

    [We all — the healthcare industry, government, and voting public –] are to blame for the lack of regulatory oversight. The Food and Drug Administration is legally empowered to regulate pharmaceuticals. Psychotherapies, however, are different. [The APA] prevented any form of standardization or check-ins by the Federal or state governments With [industry] funds squashing legislation that gets in the way the [mental health industry’s] interests. This leaves a wild-wild west scenario where the snake-oil sellers are dressed in tuxedos instead of raggedy garb, and they sell [talk therapy] panaceas.

    It’s important to note this discrepancy between the ethics and legal practice for without statutes, ethics is insufficient. A long term legal solution is required. Banning the [unproven psychotherapies] is the first step. The next is moving away from the psycho-madness of the mislabelled [mental health] craze. Secondary measures are too dangerous because as it stands, [spending time in psychotherapy] doesn’t waste away one’s weighty worries, [mainly one’s wallet.]”

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