COMMENTARY

Readers' and Author's Responses to "Evidence-Based Standards Should Apply to Dietary Supplements, Too"

Daniel Fabricant, PhD; Peter Hendriksen; Hayden B. Driscoll, DDS; Brad Jacobs, MD, MPH; Dan Hurley

Disclosures

October 29, 2007

To the Editor,

I would like to point out some factual inaccuracies in the Editorial by Dan Hurley for WebMD/Medscape General Medicine that was posted on the Internet as of July 30, 2007.[1] First, contrary to Mr. Hurley's assertion, there is ample scientific evidence from government sources and other reputable resources that dietary supplements are indeed beneficial.[2,3]

He is also incorrect in stating that "no major medical group or government agency" has recommended the use of dietary supplements. For example, the Centers for Disease Control and Prevention recommends 400 mcg of folic acid daily for women of childbearing age, either through dietary supplements or fortified foods, for the prevention of neural tube defects.[4] The American Heart Association states on their Web site that "Randomized clinical trials have shown that omega-3 fatty acid supplements can reduce cardiovascular events (death, non-fatal heart attacks, non-fatal strokes). They can also slow the progression of atherosclerosis in coronary patients."[5] In 2002, reversing a long-standing antivitamin policy, the Journal of the American Medical Association advised all adults to take at least 1 multivitamin pill each day.[6] These are just 3 examples.

And despite the fact that The New York Times published a correction to an essay by Mr. Hurley regarding his misreporting of poison control data, he persists in implying that these data are "evidence for potential harmfulness." In fact, an official from the American Association of Poison Control Centers explained that the 1.6 million reports related to supplement use -- cited here and in The New York Times essay -- refer to "exposures," most resulting in "unknown or benign outcomes."[7]

We do agree, however, with Mr. Hurley's assertion that physicians should be aware of what dietary supplements their patients are taking. Fortunately, many of them already are and recognize the growing body of research supporting the use of dietary supplements in maintaining health and preventing illness.

Very truly yours,
Daniel Fabricant, PhD
Vice President, Scientific and Regulatory Affairs
Natural Products Association
Washington, DC
dfabricant@naturalproductsassoc.org

References

  1. Hurley D. Evidence-Based Standards Should Apply to Dietary Supplements, Too. MedGenMed. 2007;9:23. Available at: http://www.medscape.com/viewarticle/559965. Accessed September 6, 2007.

  2. USDA. Dietary supplements. Available at: http://www.nutrition.gov/index.php?mode=subject&subject=ng_supplements&d_subject=Dietary%20Supplements. Accessed October 25, 2007.

  3. National Center for Alternative and Complementary Medicine. Dietary and herbal supplements. Available at: http://nccam.nih.gov/health/supplements.htm. Accessed October 25, 2007.

  4. Centers for Disease Control and Prevention. Folic acid. Available at: http://www.cdc.gov/ncbddd/folicacid/women.htm. Accessed October 25, 2007.

  5. American Heart Association. Fish and omega-3 fatty acids. Available at: http://www.americanheart.org/presenter.jhtml?identifier=4632. Accessed October 25, 2007.

  6. Fletcher RH, Fairfield KM. Vitamins for chronic disease prevention in adults: clinical applications. JAMA. 2002;287:3127-3129. Available at: http://jama.ama-assn.org/cgi/content/abstract/287/23/3127?ijkey=ff04afe2a0b684dade384d6c006c51cc66dc2ba8&keytype2=tf_ipsecsha. Accessed October 25, 2007.

  7. Hurley D. Essay; Diet Supplements and Safety: Some Disquieting Data. The New York Times. January 16, 2007. Available at: http://query.nytimes.com/gst/fullpage.html?sec=health&res=950DE1DB1030F935A25752C0A9619C8B63. Accessed October 25, 2007.


To the Editor,

What strikes me in Mr. Hurley's comment is that he focuses only on dietary supplements as a potential cause of problems. "Beyond vitamins, some physicians even recommend herbal remedies and specialty supplements." He presents this as if this is really a sin.

The scientific evidence on some products sold as dietary supplements in the United States is also quite strong, but it is not mentioned. Ginkgo and St. John's wort are some examples. In Europe, phytotherapy has reached high levels of significance in the medical profession in countries like Germany. Ayurveda and traditional Chinese medicine could not survive thousands of years if they did not work for the user. At least one line to nuance his message that all dietary supplements are dangerous, I think, is needed.

I do agree that more control might be necessary. It is quite easy to sell products without sufficient scientific back up. But, like in Europe, also in the United States there are companies taking dietary and herbal supplements very seriously. GMP production facilities and careful product development based on research are in place.

Unfortunately, the construction of the laws that define marketing authorization of medicines makes it impossible to bring herbal medicines to the standard one would like them to be. If legislation addressing the stability, safety, and efficacy of herbal medication would be drawn up, based on the typical properties of herbal medicine, one could achieve a desired quality status. But please appoint people who want this project to succeed to design these laws, people who are scientifically respected, of course, and do not leave it in the hands of scientists who only accept the current paradigm of the pharmaceutical industry. You do not send a referee of a baseball match into a basketball game either.

Mr. Hurley stated, "Evidence-based medicine is the rallying cry of a generation of physicians." This rallying cry has been fuelled by the pharmaceutical industry, the same industry that has been in the press on various ethical subjects themselves as well lately. So both "sides," herbal supplements and pharmaceutical medicine, can work on ethical behaviour.[1]

Let us focus on applied clinical investigations of plants to determine which plants contribute and which do not. Let us make laws that can judge an herbal medicine on the proper terms. Let us be clear that making money with bad products is unacceptable for society.

Kind regards,
Peter Hendriksen
Manager, New Product Development
BIONAL Nederland
The Netherlands

Reference

  1. Hurley D. Evidence-Based Standards Should Apply to Dietary Supplements, Too. MedGenMed. 2007;9:23. Available at: http://www.medscape.com/viewarticle/559965. Accessed September 6, 2007.


To the Editor,

For 30 years I have advocated a relatively simple solution to the lack of evidence-based standards for the recommendation of supplements: change the current US patent laws to allow patents to be obtained on these products.

The research for a given supplement would be completed and submitted to the FDA. If FDA approval is granted, the patent could be essentially a "rubber stamp" procedure. The proprietary rights for the patent holder could be set for 7-10 years from the date of FDA approval.

Current manufacturers of supplements could continue their sales as long as they paid a requisite royalty to the patent holder. Indirectly, the cost of the research would then be borne by the consumer, as it should be, and how it is presently with prescription drugs.

The patent holder may opt not to market the product, as it is possible that dedicated research houses would be created. This mechanism would offer the opportunity for universities to expand their research efforts while creating a sustained income from their successes. Assuming satisfactory laboratory and clinical evidence of safety and efficacy is demonstrated, the research institution, whether private enterprise or academic, would apply for regulatory (FDA) and patent approval.

To ensure consistent quality, a designated portion of the royalty revenues could be mandated to employ manufacturing facility field inspectors and product analysis technicians with the authority to close a facility should it not meet standards. This would not only protect the consumer but would be in the best interest of the patent holder who would want to protect the good name of the product and those manufacturing it.[1]

Regards,
Hayden B. Driscoll, DDS
Thousand Oaks, California
driscollhb@adelphia.net

Reference

  1. Hurley D. Evidence-Based Standards Should Apply to Dietary Supplements, Too. MedGenMed. 2007;9:23. Available at: http://www.medscape.com/viewarticle/559965. Accessed September 6, 2007.


To the Editor,

As a physician and expert in the field of integrative medicine, I agree that it's critical that physicians learn to communicate better with their patients for all sorts of reasons, including the real threat of drug-supplement, procedure-supplement, supplement-supplement, and food-supplement interactions. With that said, it's concerning to me that Mr. Hurley would limit his analysis on the efficacy of selected therapies based on "the most recent clinical trial." Mr. Hurley entitled his editorial "Evidence-based Standards..." yet he didn't apply these standards in this very article.[1]

In making technology assessment decisions using EBM standards, one accounts for the totality of the evidence prior to rendering an opinion. Take for example Mr. Hurley's statement about the lack of efficacy of echinacea. He accurately depicted the results of this RCT, which used the experimental inoculation model of rhinovirus in otherwise healthy individuals. However, a recent meta-analysis published in The Lancet Infectious Diseases showed a 58% reduction in likelihood of getting a cold and 1.4-day reduction in duration if indeed you acquired a cold.[2] We could argue about the quality to the studies in the meta-analysis and how they compared with the Turner study, but what is more concerning is the certainty of his claim (as if there is no other potential viewpoint) in the presence of contradictory evidence. This lack of consideration of the totality of evidence is not consistent with an evidence-based approach.

Mr. Hurley cites that the study by Clegg and colleagues showed no effect, but in truth their subgroup analysis of mod-severe OA patients showed benefit. Furthermore, they used a formulation that is not consistent with the widely accepted formulation considered standard of care (glucosamine sulfate). Reginster and colleagues[3] published a multicenter clinical trial in The Lancet and Pavelka and colleagues[4] in the Archives of Internal Medicine showing improvements in function/pain and slowed progression of joint space narrowing (potentially the first disease-modifying agent identified for this condition). Finally, multiple meta-analyses show potential or definitive efficacy, particularly of the Rotta product.[5,6] Again, why would he conveniently avoid including these facts in his editorial?

Finally, I concur with Mr. Hurley's premise that the dietary supplement industry is problematic. We have little awareness by patients of the need to inform treating healthcare providers on the use of dietary supplements, there is a huge potential for interactions, and we have little quality assurance of products in the marketplace.

Nonetheless, I remain mystified on why Mr. Hurley chose to entitle his editorial "Evidence-based Standards Should Apply to Dietary Supplements" when he chooses not to obey the rules of the game. One could suppose that he had an opinion prior to beginning this article and found evidence to support this perspective. In science, it's critical that we remain as objective as possible and withhold our natural propensity to formulate an opinion prior to learning the "truth" (at least as close to the truth as we can surmise at any given point in time). I look forward to his feedback.

Sincerely,
Brad Jacobs, MD, MPH

References

  1. Hurley D. Evidence-Based Standards Should Apply to Dietary Supplements, Too. MedGenMed. 2007;9:23. Available at: http://www.medscape.com/viewarticle/559965 Accessed September 6, 2007.

  2. Shah SA, Sander S, White CM, Rinaldi M, Coleman CI. Evaluation of echinacea for the prevention and treatment of the common cold: a meta-analysis. Lancet Infect Dis. 2007;7:473-480.

  3. Reginster JY, Deroisy R, Rovati LC, et al. Long-term effects of glucosamine sulphate on osteoarthritis progression: a randomised, placebo-controlled clinical trial. Lancet. 2001;357:251-256.

  4. Pavelka K, Gatterova J, Olejarova M, Machacek S, Giacovelli G, Rovati LC. Glucosamine sulfate use and delay of progression of knee osteoarthritis: a 3-year, randomized, placebo-controlled, double-blind study. Arch Intern Med. 2002;162:2113-2123.

  5. Poolsup N, Suthisisang C, Channark P, Kittikulsuth W. Glucosamine long-term treatment and the progression of knee osteoarthritis: systematic review of randomized controlled trials. Ann Pharmacother. 2005;39:1080-1087.

  6. Towheed TE, Maxwell L, Anastassiades TP, et al. Glucosamine therapy for treating osteoarthritis. Cochrane Database Syst Rev. 2005;(2):CD002946.


Author's Response:

I received dozens of personal email messages in response to my editorial, including many, like 2 of the letters published above, from people who work for the dietary supplement industry. I welcome the chance to respond.

Dr. Fabricant's letter distorts both the details and gist of my editorial. Nowhere did I write that dietary supplements have no benefit; such a broad statement about an array of substances including vitamins and minerals would be ridiculous on its face. Nor did I write, as Dr. Fabricant suggested through selective quotation, that no major medical group or government agency has recommended the use of any dietary supplement. Rather, I wrote that no such group or agency has recommended the use of multivitamins "for otherwise healthy children or adults." I remain unaware of any that does.

Dr. Fabricant repeats the mistake of many in the supplement industry in suggesting that the Journal of the American Medical Association has a "policy" on vitamins, or that it reversed that policy by offering its own recommendation on taking a multivitamin. The article cited by Dr. Fabricant was published in 2002, written by 2 physicians who believed then that taking a daily multivitamin was "prudent" for all adults. That recommendation, however, is not supported by an exhaustive review of the evidence conducted by the NIH State-of-the-Science Conference on Multivitamin/Mineral Supplements and Chronic Disease Prevention, published on September 5, 2006, in the Annals of Internal Medicine. The conference panel concluded that "the present evidence is insufficient to recommend either for or against the use of MVMs by the American public to prevent chronic disease."[1]

This is not the proper forum for discussing my essay in The New York Times. As to my Medscape editorial's reference to the 1.6 million reports received by the American Association of Poison Control Centers related to the use of supplements, I shall leave it to the reader to judge whether the resulting 251,799 hospitalizations are "evidence for potential harmfulness."

I enjoyed Mr. Hendriksen's use of the stock phrase from supplement advocates about the "thousands of years" of benefit such products have supposedly provided. I agree with him, of course, that historical usage can be an important guide to the investigation of potential therapeutics, but maintain that only those proved safe and effective in clinical trials be offered for sale to the public.

Dr. Driscoll seems to be calling for a return to the good old days of "patent medicines," on the premise that such patents could help to fund research on dietary supplements. Yet thousands of studies have already been published in leading peer-reviewed journals on all of the popular herbs, vitamins, and minerals, most of them by independent academics. My editorial, after all, called on physicians to examine this existing and ever-growing evidence base before they recommend supplements to their patients.

Dr. Jacobs's thoughtful letter is correct in pointing out that many well-designed, peer-reviewed studies have found significant benefits in echinacea and glucosamine, just as many studies have found benefits in Vioxx. The handful of major studies cited in my 351-word editorial were hardly meant to be an exhaustive review. But evidence-based recommendations must rely on a review of all the evidence, and any drug with the inconsistent findings reached by studies of echinacea and glucosamine would have little hope of winning approval by the FDA.

For at least a cursory review of the evidence on many popular supplements, I would encourage any interested reader to check out the National Center for Complementary and Alternative Medicine's Web site at http://nccam.nih.gov/. I remain proud of my book, Natural Causes, and the review it received in The New England Journal of Medicine.[2]

Dan Hurley
Freelance Medical Reporter
New Jersey

References

  1. National Institutes of Health State-of-the-Science Conference Statement: Multivitamin/Mineral Supplements and Chronic Disease Prevention. Ann Intern Med. 2006;145:364-371. Available at: http://www.annals.org/cgi/content/short/145/5/364. Accessed October 25, 2007.

  2. Book review: Natural Causes: Death, Lies, and Politics in America's Vitamin and Herbal Supplement Industry. N Engl J Med. 2007;356:2659. Available at: http://content.nejm.org/cgi/content/extract/356/25/2659. Accessed October 25, 2007.


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