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HerbalEGram: Volume 6, Number 7, July 2009
AP Publishes Series on Dietary Supplements and CAM
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During the first week of June, global news network The Associated Press (AP) launched a series of articles analyzing the safety and efficacy of complementary and alternative medicine (CAM), dietary supplements, and alternative cancer treatments. These articles, all written by AP’s medical writer Marilynn Marchione, have since been published by many of the country’s largest news organizations, including The Washington Post, USA Today, and The Houston Chronicle.
In the first article of the series, “AP impact: alternative medicine goes mainstream”1 (which was also published under various versions of the title “Top hospital willing to try ‘mystical mumbo jumbo’”), Marchione claims that people use alterative medicines, such as herbal supplements, with blind faith. However, they often encounter deceptive marketing and products that directly threaten their health, can cause cancer patients to die, and lead people with clogged arteries to have heart attacks, she writes.
To support her assertions, Marchione cites an AP review of “dozens of studies and interviews with more than 100 sources.” The Dietary Supplement Health and Education Act of 1994 (DSHEA) allows a safety net “far flimsier” than that for pharmaceuticals, Marchione writes. Later in the story, she writes that, despite millions of taxpayer dollars spent on research, the National Center for Complementary and Alternative Medicine (NCCAM) at the National Institutes of Health has not found any cures or major treatment advances, aside from acupuncture for certain uses and ginger for chemotherapy-related nausea.
In another article of the series, “Tests show many supplements have quality problems,”2 Marchione writes about the safety of dietary and herbal supplements. She discusses aspects of DSHEA, which she claims have led to more cases of product contamination and/or adulteration, low potency, undisclosed levels of pharmaceutical drugs, increased herb-drug interactions, exaggerated and/or unsupportable health-related claims, and other problems. When elaborating on issues of contamination and potency, Marchione’s evidence depends heavily on ConsumberLab.com, a for-profit provider of laboratory test results on dietary supplements and other food-related consumer products.
Four of the remaining articles of the series focus on alternative medicine as cancer treatment, some of which tell stories of cancer patients who have tried these therapies unsuccessfully.3,4,5,6 Another article paints a picture of the size and scope of the natural products industry, which Marchione names “Big Herba,”7 and another that criticizes NCCAM’s spending and research projects.8 Marchione has written a total of 8 articles for the AP series.
As is often the case with articles that focus on problems of the dietary supplement industry—problems that can sometimes pose legitimate health concerns—some of these articles fall into the common media trap of providing unbalanced, misleading, and/or exaggerated information. An article or series of articles produced by AP cannot be definitive or even highly detailed as the target audience is a general newspaper reader, who likely has limited knowledge or experience of scientific, medical, and/or regulatory matters. It is the nature of such broad-scale media to try to simplify complex issues and/or omit information that can qualify sweeping conclusions, thereby producing inferences to the reader that can be misleading, if not altogether inaccurate.
One primary consideration that must be acknowledged when reading the AP series is that the author gives little to no recognition of any actual benefit of any herbal or dietary supplements. If there is no officially recognized benefit, the perception of risk is increased. (In the process of determining the safety and efficacy of conventional pharmaceutical drugs, a certain level of risk is deemed acceptable in relation to the documented benefit. Thus, without reporting that there are any benefits to taking herbal or dietary supplements, the perceived risks seem far greater.) The AP series must be viewed within this context.
The following comments are meant to clarify and/or correct some of the statements in a few of the articles in the AP series that focus on herbs specifically and dietary supplements in general. This commentary is not intended to be exhaustive.
Adverse events. In the “quality problems” article, the author’s language creates an exaggeratedly negative view of dietary supplement safety. She writes, “Tens of thousands of supplement-related health problems are handled by US poison control centers each year, according to a report in the New England Journal of Medicine in 2002.”2 As noted in an article that I co-wrote with Rick Kingston, PharmD, of SafetyCall International in Minneapolis, MN, in HerbalGram 60 in 2003, it is not appropriate, accurate, or responsible to take raw data from the American Association of Poison Control Center’s (AAPCC) TESS (Toxic Exposure Surveillance System) database and report these as adverse events or “health problems,” as many or most of these are simply “incident reports,” i.e., reports—usually of minor therapeutic significance—from consumers or healthcare professionals of an incident that may be associated with the use of a dietary supplement, but for which no causal relationship can be established.9 Further, the AAPCC/TESS report in 2001 included numerous AEs on the controversial herb ephedra (Ephedra sinica), which has been subsequently removed from the US market. Such information, as provided in the AP article, is not representative of most herbs sold in the United States.
Also, according to Rick Kingston, who is a highly-regarded expert on adverse event reporting systems, “It is worth noting that in addition to DS, personal care products and cosmetics are some of the most commonly reported substances or products in the TESS database and they are indicative of the common misunderstanding about incident reports to such databases, regardless of the category of products being reported” (e-mail to M. Blumenthal, June 30, 2009).
In this same vein, the AP article states, “Until last year, supplement makers were not required to report problems to the FDA, and even now they must report only serious ones. The agency estimates that more than 50,000 safety problems a year are related to supplement use.”
This statement could lead readers to infer that FDA estimates that there are more than 50,000 serious adverse events for dietary supplements each year. In fact, this relates to the agency’s estimate of total incidents, many of which are minor or moderate. This statistic was documented in a recent Government Accountability Office (GAO) report: “…FDA recently estimated that the actual number of total adverse events—including mild, moderate, and serious—related to dietary supplements per year is over 50,000, which suggests that underreporting of adverse events limits the amount of information FDA receives.”10
In addition, a measure of balance would have been added to Marchione’s article if she were to have reported that the leading dietary supplement trade associations not only supported the legislation to require manufacturers of dietary supplements and over-the-counter drugs to report all serious adverse events, but some responsible members of the industry even helped to initiate this legislation.
Pre-Approval on Safety and Efficacy. A lack of clarity and depth of knowledge of the regulatory system for herbs and other dietary supplements under DSHEA is evident throughout the series of articles, as well as a possible lack of adequate fact-checking by AP, as evidenced by the following statement in the article about the regulation of the dietary supplement industry:
“The Dietary Supplement and Health Education Act of 1994 exempted supplements from needing federal Food and Drug Administration approval, or proof of safety and effectiveness, before they go on sale.”7
This statement is only partially true and omits an increasingly important aspect of DSHEA—the provision for FDA review and pre-market approval of new dietary ingredients (NDIs). It is true that most dietary supplements do not need pre-market approval for safety or efficacy, as they are classified as foods, not drugs. Yet, as many people—particularly industry members—already know, DSHEA requires that an importer or manufacturer of an NDI must submit to the FDA, 75 days prior to the ingredient’s introduction, a dossier documenting the safety of said ingredient. FDA then has the opportunity to review the safety data and the authority to accept or object to the information, thereby allowing the ingredient to be sold as or in a dietary supplement, preventing it from being sold, or requiring more safety data from the importer/seller. This provision was added to DSHEA to give the FDA the added authority to protect consumers by keeping potentially unsafe new ingredients that were not in the US market prior to the passage of DSHEA in October 1994 from being introduced into the country without some form of FDA review. (Even though this provision has been part of federal law since 1994, the FDA has yet to publish any guidance to clarify many questions regarding NDIs, despite repeated requests from industry trade groups et al.)
A further point worth considering in regards to safety is that, in numerous clinical trials in which an herbal or phytomedicinal preparation is tested directly against a conventional pharmaceutical drug used as a “reference control,” almost invariably there are significantly less adverse effects documented to the phytomedicine compared to the pharmaceutical drug.
Efficacy, meanwhile, is a complex and difficult matter. Since herbs and dietary supplements are foods, not drugs, they are not legally required to show efficacy to be sold in the market. A cogent question can be asked, “Effective for what?” Therapeutic claims are not allowed by DSHEA, just statements of nutritional support and so-called “structure/function” claims on how the dietary supplement affects the structure or function of the human body. Each herb sold in the US market usually has multiple applications in various forms, and cost of proving efficacy for these usually nonpatentable items is a disincentive to any business to make the multi-million dollar investment required for new drugs.
Another point worth discussing is that the herb and dietary supplement industry is not homogeneous or monolithic; it is highly fragmented and pluralistic, made up of many companies who earnestly and genuinely attempt to produce and market safe, high quality products in a responsible manner. Many of these companies belong to one or more of the various industry trade groups, each of which is involved in one way or another in various attempts at self-regulation. Many of the problems that arise with herbs and dietary supplements, as catalogued by Marchione in her series, appear to be directly attributable to companies that are not among the more responsible elements of the industry.
Continuation of the AP Series
One June 24, Marchione contacted the American Botanical Council for information on a story she was preparing on the use of dietary supplements on companion animals. She made reference to the article ABC had published in HerbalGram 82, “The Expanding Market and Regulatory Challenges of Supplements for Pets in the United States.”11 That AP article has not been published as of the distribution date of this issue of HerbalEGram.
—Mark Blumenthal
References
1. Marchione M. AP Impact: Alternative medicine goes mainstream. The Associated Press. June 7, 2009. Available at: http://www.google.com/hostednews/ap/article/ALeqM5jJ6ymBVg8DzG8BDHwfWbr-ex1KKgD98LUR380. Accessed July 1, 2009.
2. Marchione M. Tests show many supplements have quality problems. The Associated Press. June 9, 2009. Available at: http://www.google.com/hostednews/ap/article/ALeqM5ihv9fazo-aCAZ-SAdw9Rl5QusxCQD98N93HG0. Accessed June 17, 2009.
3. Marchione M. 60% of cancer patients try nontraditional medicines, supplements. The Associated Press, published in USA Today, June 8, 2009. Available at: http://www.usatoday.com/news/health/2009-06-08-cancer-supplements_N.htm. Accessed June 17, 2009.
4. Marchione M. A sad case: she chose herbals over surgery. The Associated Press, published in The Atlanta Journal-Constitution. June 10, 2009. Available at: http://www.ajc.com/services/content/health/stories/2009/06/10/remedies_rectal_cancer.html. Accessed June 17, 2009.
5. Marchione M. Cancer patient learns herbals can interfere. The Associated Press. June 8, 2009. Available at: http://www.google.com/hostednews/ap/article/ALeqM5h7Rfvobwj-8nl_B-sdEmyoutjEoAD98MOIQ83. Accessed June 17, 2009.
6. Marchione M. ‘You’ll try anything,’ says cancer patient. The Associated Press, published in Forbes. June 8, 2009. Available at: http://www.forbes.com/feeds/ap/2009/06/08/ap6517248.html. Accessed June 17, 2009.
7. Marchione M. Vitamins, herbal supplements are big business. The Associated Press, published in The Miami Herald. June 12, 2009. Available at: http://www.miamiherald.com/business/story/1093696.html. Accessed June 17, 2009.
8. Marchione M. AP Impact: $2.5B spent, no alternative med cures. The Associated Press, published in The Atlanta Journal-Constitution. June 10, 2009. Available at: http://www.ajc.com/health/content/health/stories/2009/06/10/unproven_remedies_cures_billions.html. Accessed June 17, 2009.
9. Kingston R, Blumenthal M. Rational Perspective on Adverse Events Reports on Herbs: Misinterpretation of Adverse Reactions Tabulated in the TESS Annual Report of the American Association of Poison Control Centers as They Relate to Ephedra Dietary Supplements. HerbalGram. 2003; 60:48-53.
10. United States Government Accountability Office. Dietary Supplements: FDA should take further actions to improve oversight and consumer understanding. GAO-09-250; January 2009. Available at: http://www.gao.gov/new.items/d09250.pdf.
11. Cavaliere C. The expanding market and regulatory challenges of supplements for pets in the United States. HerbalGram. 2009;82:34-41. |
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