By Guy Gugliotta
Washington Post Staff Writer
Citing potential danger to public health, a leading medical journal yesterday ordered early release of a study concluding that products containing the energy-boosting and weight-loss supplement ephedra can pose serious medical problems, including permanent disability and death.
Scientists at the University of California at San Francisco undertook the study at the behest of the Food and Drug Administration to address health problems associated with ephedra, a powerful stimulant that is one of the most popular dietary supplements.
The study was scheduled for publication in the Dec. 21 issue of the New England Journal of Medicine, but editors at the journal decided to release it early, citing “potential clinical and public health implications.”
The California researchers analyzed 140 “adverse event reports” on ephedra provided by the FDA, and concluded that 43 were “definitely” or “probably” caused by the supplement, among them three deaths, seven instances of permanent injury and four cases requiring ongoing medical treatment.
“Because of the severity of the adverse events that we reviewed, and, in particular, the occurrence of events that caused permanent disability and death, we conclude that dietary supplements that contain ephedra alkaloids pose a serious health risk to some users,” researchers Christine A. Haller and Neal L. Benowitz said in the study.
The journal’s decision to release the article more than a month before its scheduled publication gave a boost to public health officials locked in a vituperative debate with the supplements industry over the safety of ephedra.
Under law, ephedra products are sold as foods, and do not have to undergo pre-market clearance by the FDA. The industry markets ephedra as a diet aid or energy booster, and has fought FDA efforts to impose dosage limits on the supplement. The agency has asserted that ephedra can cause adverse reactions ranging from nervousness and insomnia to hypertension, rapid heart beats, heart attack, seizure and stroke.
The study “confirms that ephedra as sold in dietary supplement form is a public health threat,” said Bruce Silverglade, legal affairs director of the Center for Science in the Public Interest, a consumer advocacy group. “The evidence is now in. This study should provide a basis for the FDA to move ahead with regulatory limits on its sale.”
Gregory Curfman, the journal’s executive editor, said the articles are released early “three or four times a year,” and only in cases involving public health concerns. He said the journal had no desire to make a political statement about ephedra or “inject ourselves” in a political dispute: “We look at the data, and treat each and every manuscript on its own merits.”
The prepublication “could change the debate,” acknowledged Michael McGuffin, president of the American Herbal Products Association, an industry group. “If the New England Journal of Medicine thinks ephedra has public health implications, it is important.”
McGuffin noted, however, that the article was based on only one of seven reports filed to the FDA analyzing the 140 case reports. The reports have been publicly available for seven months, with the Haller-Benowitz analysis making one of the strongest cases for regulation.
McGuffin noted that the industry’s experts reviewed the reports “with far different results,” and criticized the journal article for what he said were several errors of fact. The journal’s credibility “was challenged,” he said, “because it appears this was not properly reviewed.”
Toxicologist Theodore Farber, who studied the reports for the industry’s Ephedra Education Council, noted that the FDA’s analysts themselves could not agree on the degree of credibility to give individual case reports, because the FDA’s data were so flawed and collected so unsystematically “that they should never be used for a causal analysis.”
Benowitz, chief of clinical pharmacology at UCSF, said in an interview he understood the data’s shortcomings, “but there is enough here to raise a flag. The industry insisting that the public health community prove causation is not appropriate,” he added, “not when you’re marketing something that’s supposed to promote health, and it’s hurting people.”