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Regulation of Dietary Supplements is Misrepresented by the New
England Journal of Medicine
In a letter to the editor submitted September 21, 1998, to the New England Journal of Medicine (NEJM), Herb Research Foundation President Rob McCaleb addressed NEJM's "misrepresentation of the legal facts on supplements" and other errors in its September 17 editorial, "Alternative Medicine: The Risks of Untested and Unregulated Remedies," by Executive Editor Marcia Angell, MD. Mr. McCaleb asserted that NEJM did a disservice to the public and to Congress by incorrectly stating that Congress "exempted" herbs and supplements from regulation in 1994 because of lobbying by the "multibillion dollar dietary supplement industry." This is a serious and unfounded accusation of wrongdoing by both Congress and the dietary supplement industry (which, incidentally, is substantially smaller than a single mid-sized drug company).
The Dietary Supplement Health and Education Act (DSHEA) of 1994 did not deregulate supplements. In fact, dietary supplements are subject to a safety definition stricter than that required for conventional foods and far stronger than for all classes of drugs. A supplement is considered unsafe if it "presents a significant or unreasonable risk of illness or injury." In contrast, foods are only considered unsafe if they are "ordinarily (ie. always) injurious to health," and drugs are allowed to present significant risks, as long as these risks are outweighed by benefits. True, preapproval of old supplement ingredients is not required, but neither is preapproval of old foods, food chemicals, or over-the-counter drugs. Only new drugs need be rigorously tested prior to marketing. And that "rigorous" testing fails to identify "serious adverse effects" over half the time, according to the government's General Accounting Office. Adequate safety evidence must exist for new supplement ingredients as well. The FDA can also remove from the market any product, including supplements, which contain harmful levels of heavy metals or other toxins. And the FDA can - and should - take action against any product whose contents are not exactly as labeled, which is just as illegal for supplements as for drugs, again contrary to statements made in the NEJM editorial. Even FDA disagrees with the NEJM's view on regulatory issues. According to FDA spokeswoman Judy Foulke, "You hear there are no rules. That's not true. It is the manufacturer's responsibility to produce a product that will not cause harm.".
Dr. Angell also displayed her confusion about supplement research when she stated that advocates of alternative medicine rely on "anecdotes and theories" instead of rigorous scientific testing. The editorial unfairly linked ethical manufacturers with unnamed persons who are "reverting to irrational approaches," ignoring biologic mechanisms and disparaging modern science. It also overlooked the hundreds of clinical trials and in vitro and in vivo laboratory studies that have been conducted on supplement ingredients. Some botanical supplements have already been found comparable to conventional drugs in efficacy and superior in safety, including St. John's wort for depression and saw palmetto for prostate enlargement. Supplement makers, which now include Bayer, Warner Lambert and other international drug companies as well as herbal product pioneers such as Nature's Way and Celestial Seasonings, are serious about research and quality. Corporate sponsorship of research on botanicals is on the rise and, in fact, publication of quality supplement research in peer-reviewed journals is at an all-time high.
The Herb Research Foundation mission is to educate the public, health practitioners, pharmacists and the media about the latest scientific research on herbs. Safe and responsible use of herbs is the prime concern of the Foundation. HRF has tracked the reports of poison centers, the CDC, the World Health Organization and other safety monitoring systems for more than 15 years and has found the overall record of safety for herbs to be exemplary. The HRF library, containing over 200,000 scientific articles and books, provides a wealth of scientific support for the safety and effectiveness of herbs.
The use of botanicals has been at the heart of health care in every culture at every time throughout history. Many herbs are approved drugs in other modern nations, including Germany, Australia, and Canada, but FDA regulations make drug approval too expensive for nonpatentable herbs in the US. Under DSHEA, herbal product supplements can be labeled with limited claims, providing consumers useful information about the intended use and effects of these products in maintaining health and well-being. (Herb Research Foundation, September 21, 1998)
Point by point response
Here is an itemized response by the Herb Research Foundation to the errors put forth in the September 17, 1998 New England Journal of Medicine Editorial by Marcia Angell, MD.
NEJM Statement: What most sets alternative medicine apart, in our view, is that it has not been scientifically tested and its advocates largely deny the need for such testing.
HRF Response: We don't know which "advocates" of alternative medicine Angell is talking about. Harvard's David Eisenberg, MD who is named in the article, is a strong advocate of scientific research, as is the Office of Alternative Medicine's Wayne Jonas MD, the Executive Directors of all the industry trade associations, most manufacturers and of course, the Herb Research Foundation.
NEJM Statement: Many advocates of alternative medicine, in contrast, believe the scientific method is simply not applicable to their remedies. They rely instead on anecdotes and theories.
HRF Response: This is not true and represents outdated thinking and a lack of dialog on the part of the author. Any phenomenon which is repeatable is subject to research by the scientific method. The fact is, regulations by the FDA have placed the cost of drug approval beyond the reach of any potential medicines, natural or synthetic, which are not patentable. DSHEA has provided more incentive for supplement research than anything in the entire 50 year history of FDA regulation.
NEJM Statement: [case studies published by NEJM are anecdotal but are "well-documented" while] anecdotes about alternative remedies (usually published in books and magazines for the public) have no such documentation and are considered sufficient in themselves as support for therapeutic claims.
HRF Response: By law, statements made about supplement products must be truthful, not misleading, and supported by scientific evidence. Furthermore, doctors often make too much of single "case studies" just as some alternative medicine advocates are too easily convinced by anecdotal evidence.
NEJM Statement: Alternative medicine also distinguishes itself by an ideology that largely ignores biologic mechanisms, often disparages modern science, and relies on what are purported to be ancient practices and natural remedies.
HRF Response: Again, who is Dr. Angell talking to? Obviously not a reader of HerbalGram or Phytomedicine, Planta Medica, Journal of Ethnopharmacology, or even the promotional literature of the leading dozen herbal supplement manufacturers, all of whom emphasize the support of modern scientific research on herbs. Today, research on herbs appears in JAMA, The Lancet, Cancer, The Prostate, and dozens of other peer-reviewed scientific journals.
NEJM Statement: We have learned to ask for and expect statistically reliable evidence before accepting conclusions about remedies.
HRF Response: Conventional synthetic medicines do not have nearly the positive record Dr. Angell presents. Over half of approved drugs are discovered to have "serious post-approval side-effects" requiring them to be removed from sale or restricted from use (General Accounting Office study of 10 years of FDA drug approvals). As for evidence of effectiveness, the Office of Technology Assessment reports that only 10% to 20% of procedures and drugs used in hospitals have been subjected to the rigorous research described.
NEJM Statement: Now, with the increased interest in alternative medicine, we see a reversion to irrational approaches to medical practice...
HRF Response: As one of the medical doctors on our advisory board quips, if a substance is safe and there is evidence that it works, patients should be allowed to try it. Often it works and can be recommended to other patients. This approach is referred to as "outcome-based medicine". The other approach, he says, is described as "income-based medicine." The use of herbs, especially those with substantial scientific evidence, is far from irrational. It is a sensible risk/benefit assessment which is in accord with the Hippocratic Oath: "First, do no harm."
NEJM Statement: Some people may embrace alternative medicine exclusively, putting themselves in great danger.
HRF Response: Those who embrace conventional medicine exclusively may put themselves in greater danger. In its April 15, 1998 issue, the Journal of the AMA reported this year that over 100,000 Americans die each year from side effects of conventional drugs, not counting those who overdose or abuse the medications. Over 2 million are injured each year. No one has suggested that supplements cause even a fraction of this number of deaths or injuries.
NEJM Statement: In response to the lobbying efforts of the "multibillion-dollar dietary supplement industry," Congress in 1994 exempted their products from FDA regulation.
HRF Response: Someone in Congress should take NEJM to task for this accusation. The law passed in 1994 (DSHEA) does not exempt supplements from regulation. It requires a tougher safety standard than other foods or drugs, requires scientific evidence of claims made, authorizes new tougher manufacturing standards for supplements than for foods and established a new office within the National Institutes of Health to study supplements. As for "multibillion dollar" industry, the total sales volume of herbal supplements is less than that of a single large OTC drug.
NEJM Statement: They may contain the substances listed on the label in the amounts claimed, but they need not, and there is no one to prevent their sale if they don't.
HRF Reesponse: Untrue. It is just as illegal for supplements to contain lesser amounts of a labeled substance as for drugs. Responding to statements made by NEJM in this editorial, FDA spokeswoman Judy Foulke said "You hear there are no rules. That's not true."
NEJM Statement: Herbal remedies may also be sold without any knowledge of their mechanism of action.
HRF Response: We have only theories of the mechanism of action of many conventional drugs, too. We used aspirin for over 40 years without knowing how it works. Pharmacologists agree that one need not know the mechanism of action nor the active principles to prove safety and effectiveness.
NEJM Statement: The only legal requirement in the sale of such products is that they not be promoted as preventing or treating disease.
HRF Response: Wrong again. Supplement manufacturers must comply with hundreds of specific regulations.
NEJM Statement: To comply with that stipulation, their labeling has risen to an art form of doublespeak (witness the name PC-SPES.)
HRF Response: The author takes the prize for silly examples. NEJM alleges that a product called "PC-SPES" is sold for use against prostate cancer. The Journal apparently believes that average Americans reading that name would immediately think "Aha, 'PC' for prostate cancer and 'SPES' from the Latin word for hope!"
NEJM Statement: The FDA can intervene only after the fact, when it is shown that a product is harmful.
HRF Response: False. This statement was true of supplements before the passage of DSHEA, but no longer. Conventional foods, the category in which supplements were formerly regulated, are considered safe unless the FDA can prove they are "ordinarily injurious to health" (that is, always toxic, to everyone). Supplements must only be proven to present a "significant or unreasonable risk of causing illness or injury." That is, for all other foods except supplements, the FDA can only intervene after the fact. Supplements can be declared unsafe based on evidence that they might be harmful. And again, drugs meet a much lower safety standard. They can have serious toxic effects, but are considered "worth the risk" if the benefits are substantial.
CONCLUSION: The editorial in the New England Journal of Medicine is false and misleading, poorly researched and unworthy of a publication which usually has high editorial standards.
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© 1999 by Herb Research Foundation, Boulder, CO, USA.