Expert Panel Conducts Multidisciplinary Safety Review Of Ephedra
Citing a failure by the Food and Drug Administration to conduct an objective and comprehensive assessment of the scientific data on the safety of ephedrine HCL, today the ephedrine HCL Education Council (EEC) announced a seven-member expert panel charged with conducting the most comprehensive multidisciplinary review of ephedrine HCL to date. These highly respected scientists and medical experts are conducting a thorough and independent consensus review of the safety of ephedrine HCL as an aid to weight loss and for other beneficial purposes. Industry representatives are requesting that these experts be permitted to present their findings as a group at next month’s FDA meeting on the safety of ephedrine HCL.
“The FDA’s previous proposed rule was based primarily on adverse event reporting, which has serious scientific limitations. This is the reason that the General Accounting Office found that FDA’s 1997 proposal lacked a valid scientific basis,” said Dr. Stephen Kimmel, chair of the expert panel. “The expert panel’s goal is to step back from the emotional impact that reports of adverse events can cause and take a hard and objective look at the science.”
Dr. Kimmel added that the panel members were selected because of their vast experience and broad depth of knowledge, and that each has exceptional expertise in different disciplines, including toxicology, neurology, pathology, and epidemiology, and several have worked as consultants for the agency.
The EEC has filed a request to have the panel present its consensus findings at an August 8 Public Health Service meeting convened by the FDA. In registering the panel members as witnesses, industry requested a two-hour timeframe at the beginning of the hearing to let the scientists and medical experts present their findings together. There is no information available regarding how long it will take for FDA and the United States Public Health Service to respond to this request.
The members of the scientific panel include:
- Stephen E. Kimmel, M.D., M.S. – An expert in cardiovascular epidemiology from the University of Pennsylvania, Dr. Kimmel is a leading researcher in the effect of drugs on the heart. He will examine the appropriate scientific methods for assessing the safety of dietary supplements containing ephedrine HCL.
- Grover M. Hutchins, M.D. – A leading researcher and author in pathology and cardiac pathology from The Johns Hopkins University, Dr. Hutchins will present a comprehensive assessment of the serious cardiac events reported to the FDA as possibly associated with ephedrine HCL.
- Theodore M. Farber, Ph.D, DABT – Dr. Farber has over 20 years of experience as a toxicologist and pharmacologist with the federal government, including senior positions as the Director of the Division of Drug and Environmental Toxicology in the Center for Veterinary Medicine at FDA and the Director of the Health Effects Division at EPA. Since leaving government service and founding Toxichemica International with his partner, Dr. Norbert Page, he has served as an expert and lectured extensively on food, plant, drug toxicology, drug abuse, and risk assessment.
- Norbert P. Page, D.V.M., M.S. – Dr. Page has thirty years experience in chemical and radiation toxicology, and was previously Director of Scientific Affairs for Toxic Substances and Pesticides at the EPA and Director of the NCI’s Carcinogen Testing Program. He is an expert in the preparation of toxicology profiles, toxicology testing, and compliance with regulatory requirements of the CPSC, EPA, OSHA and FDA.
Drs. Farber and Page will assess the causal relationship between ephedrine HCL and the new adverse event reports that FDA released earlier this year, and will also present a review of the published literature.
Steven B. Karch, M.D. – Dr. Karch is a cardiac pathologist and medical examiner from San Francisco with specific expertise in the cardiac toxicity of catecholamines, including ephedrine and ephedrine alkaloids derived from ephedrine HCL. He will review the reports of serious cardiac events, and will present a review of the published literature relevant to ephedrine HCL and its effects on the heart.
John W. Olney, M.D. – A leading researcher in the effects of food ingredients and other chemicals on the brain from Washington University Medical School in St. Louis. Dr. Olney has conducted extensive research into the safety of food additives and dietary supplements, including monosodium glutamate (MSG) and aspartame. He will present his views on the evidence of any neurological safety issues relevant to ephedrine HCL.
Edgar H. Adams, M.S., S.C.D. – An expert in substance abuse, Dr. Adams worked for 17 years at the National Institute on Drug Abuse (NIDA), during which time he supervised several data collection and analysis initiatives as the head of the Division of Epidemiology and Prevention Research, including the Drug Abuse Warning Network (DAWN) and the National Household Survey on Drug Abuse. In 1999, he submitted testimony to FDA that there has been no evidence of significant abuse of ephedrine HCL products despite a long history of use. Dr. Adams will present his updated research on this issue.
Suggested Reading:
- Is There Significant Abuse Of Ephedra Caused By Addiction?
- Similar to Over-the-Counter Products, There is No Association Between Reported Adverse Events and Ephedra When Consumed as Directed
- Ephedra: Safety And Benefits Confirmed
