Dr. John Hathcock's letter to the Washington Post

February 9, 2001

Editor
The Washington Post
1150 15th Street, NW
Washington, DC 20071

letters@washpost.com

Dear Sir:

The article "Woman Wins $13.3 Million Against Dietary Company" by Guy Gugliotta in the February 8 Washington Post misleads by mischaracterizing or omitting several important facts.

Mr. Gugliotta states that the Food and Drug Administration (FDA) has "implicated" ephedra in hundreds of cases reported to the agency as though this is sufficient evidence to conclude a cause and effect relationship. He attempts to support this implication by calling attention to a New England Journal of Medicine article that repeats a medical opinion released by FDA last year—an opinion from outside medical experts not supported by FDA own experts. In contrast, the opposite conclusion was reached by the General Accounting Office in its 1999 report, which determined that the adverse event reports underlying FDA’s proposed ephedra regulation lacked scientific reliability. Most recently, an expert, neutral toxicology consulting firm, Cantox Health Sciences International, applied established criteria for causality adopted in the risk assessment model developed by the National Academies for application to foods, including dietary supplements, to perform a risk assessment of ephedra. Cantox determined that ephedra could be used safely as a dietary supplement when taken according to specified serving and daily dosage limitations, and appropriate directions and conditions of use. Finally, Mr. Gugliotta further implicates the "1994 dietary supplement law" while failing to acknowledge that the same law authorizes FDA to prohibit the addition of synthetic ephedrine to dietary supplements and empowers FDA to remove supplements from the market that are mislabeled and/or fail to comply with good manufacturing practice regulations.

Overall, the article incorrectly portrays the scientific evidence as being in favor of the court decision. It omits any reference to the strong body of science in the opposite direction, and in this way is wrong and misleading. The readers of the Washington Post deserve better.

Sincerely,
John N. Hathcock, Ph.D.
Vice President, Nutritional and Regulatory Science