| Comment Record|
Dr. Donald Marcus ||
2003-03-31 15:21:01 |
Baylor College of Medicine |
Health Professional |
| Comments for FDA General |
1. General Comments
The Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Re: Docket No. 95N-0304 - Comments on Proposed Rule on Ephedra
I am a Professor of Medicine and Immunology at Baylor College of Medicine in Houston, TX. I provide education on alternative medicine to medical students and physicians, and I was the coauthor of a recent article in the New England Journal of Medicine on the need for regulation of botanical medicines (Marcus, D.M. and Grollman, A.P., Botanical Medicines: the need for new regulations. New Engl J Med 2002; 347:2073-2076).
1) The dangers of ephedra - The RAND report severely underestimates the dangers of ephedra because of the strict and unrealistic standards they employed to identify adverse events. The RAND report relied on published case studies and did not take into account many unpublished events that were reported to Poison Control Centers, deaths in the U.S. armed forces, and lawsuits against manufacturers of ephedra products that have been settled and sealed from public scrutiny. They also failed to weigh the fact that manufacturers are not required to report adverse events to the FDA. The FDA estimate of over 100 deaths and 2,000 adverse events is also unquestionably an underestimate.
2) Appropriateness of warning labels - This would be a useful, but limited and ineffective, step. Most consumers don't read labels. Labels of botanical products contain a statement that the FDA has not approved the product. A recent Harris poll (www.harrisinteractive.com/news) revealed that a majority of consumers believe that manufacturers are required by the FDA to place warnings on dietary supplement labels; that supplements must be approved by the FDA; and that health claims for supplements must be based on solid scientific evidence. All of those beliefs are incorrect. There is no evidence that warning labels on alcohol and tobacco products had any effect on their consumption.
3) Removal of ephedra products from the market - Botanical products that contain ephedra and other ephedrine alkaloids such as synephrine are marketed to promote weight loss and to improve athletic performance. Reduction of weight is a long-term problem, and there is no evidence for either the efficacy or safety of chronic treatment with ephedra. On the other hand, there is considerable evidence that ephedra may cause permanent injury or death. In view of this unfavorable risk/benefit ratio I believe that ephedra presents an unreasonable risk of significant injury. The FDA has the authority and responsibility to remove ephedra, and similar products containing ephedrine-like alkaloids, from the market. If herbal medicines were regulated appropriately, ephedra would have been removed from the market long ago.
In view of the overwhelming consensus in the medical community about the need to remove ephedra from the market, the reluctance of the FDA to take action has been puzzling. A recent US News and World Report article revealed that the FDA counsel, Daniel Troy, was formerly a lawyer for the dietary supplement and tobacco industries. To avoid the appearance of a conflict of interest, it would be appropriate for Mr. Troy to excuse himself from participating in decisions that affect his former clients.
4) Are changes needed in the laws that regulate dietary supplements? - There is
an urgent need for changes, and specific recommendations were made in two recent articles (Fontanarosa et al, JAMA 2003; 289:1568-1579; and Lewis and Strom, Ann Int Med 2002; 136: 616-618), as well as in our article. Moreover, a majority of the American public supports the idea of new rules that would require the FDA to review the safety of new dietary supplements before their sale; that would give increased authority to the FDA to remove unsafe products from the market; and that would regulate advertising claims about the health benefits of dietary supplements (Blendon RJ, et al. Americans' views on the use and regulation of dietary supplements. Arch Intern Med 2001;161:805-810).
The designation of botanical medicines as dietary supplements by the Dietary Health and Supplement Act of 1994 had no scientific basis, and it has caused the public great harm. Calcium, iron and vitamin D are dietary supplements. Ephedrine, one of the ingredients of ephedra, is a drug that was used formerly for treatment of asthma, and it should be regulated as an over-the-counter drug. I believe that new legislation could regulate herbal medicines without denying the public access to legitimate dietary supplements.