Aug. 7, 2000 (Washington) -- The popular weight-loss herb ephedra has been under fire lately, with claims that it can have dangerous side effects. But now a panel of experts who conducted an industry-financed review may turn down the heat, saying the herb, also known as ma huang, does not cause serious heart-related side effects when used as directed.
This conclusion has now set the stage for a two-day public meeting sponsored by the Department of Health and Human Services (HHS), scheduled to begin Tuesday, regarding how ephedra-containing products should be regulated.
Drawing their conclusions from a review of about 1,200 side effects reported to the FDA, the seven-member panel said Monday that conservative estimates show that there is no greater risk of heart-related side effects occurring in ephedra users than in the population at large.
Based upon those same reports, the FDA in April proposed a rule that would ban the combination of ephedra with stimulants such as caffeine, and would require a warning label to outline and highlight potential side effects, such as heart attacks, strokes, and seizures.
Proponents of the dietary supplement believe the FDA rule is unmerited, and if passed, could in effect act as a ban on ephedra containing products, of which more than half contain caffeine. They now plan to use this latest review, paid for by the industry group American Herbal Products Association (AHPA), to criticize the FDA proposal at the two-day meeting.
Theodore Farber, PhD, DABT, a poisons expert and member of the panel, tells WebMD that the pure number of adverse events associated with ephedra might suggest a cause-and-effect relationship, but that doesn't hold up upon review by the multidisciplinary panel and when compared to the usual incidence of heart-related events in the general population. Farber is a past office director of the FDA
Advocates for ephedra already have won the first round of this ongoing bout with the federal agency. In June 1997, the FDA proposed a rule that would have banned the marketing of ephedra for weight loss and weight management. But the FDA was forced to abandon that rule, thanks in large part to a Government Accounting Office (GAO) report that found no basis for the agency's recommendations.
Still, the outcome of this upcoming round is anything but a given. There is no question that ephedra does pose a distinct danger to at least certain patient populations, a number of independent experts say.
Considering that these products are used by millions of people, the overall risk to the general population is difficult to assess, admits Neal Benowitz, MD, a poisons expert, who recently conducted an independent review of some more side effects associated with ephedra for the FDA. His review of about 139 cases did uncover about five cardiac arrests, four strokes, and several cases of high blood pressure that most likely resulted from the use of ephedra containing products, says the professor at the University of California at San Francisco.
The FDA could build a very good case to say that the real danger results from ephedra's combination with caffeine, Benowitz adds. While ephedra appears to be a fairly benign compound, when combined with caffeine its heart-related side effects appear compounded, he says.
But whether the FDA will succeed in its attempt to make the case for a ban on the combination of ephedra with caffeine remains to be seen. After all, there also are a number of advantages to be considered from the combination of ephedrine and caffeine, supporters of the dietary supplement point out.
For one, "obesity is a major problem in the U.S.," notes Stephen Kimmel, MD, MS, an expert in cardiovascular epidemiology who served as chairman of the AHPA panel. "Everyone who is obese should see a physician," he tells WebMD. But there also is a definite benefit to having a non-prescription product available for those people that do not see a physician, says the research professor from the University of Pennsylvania.
Current data also seem to support the conclusion that ephedra combined with caffeine represents no more danger than that posed by over-the-counter asthma drugs that contain the same formulation, and for which the FDA admits to having few adverse event reports, Kimmel tells WebMD.
As for whether weight loss is achieved, a soon to be published study conducted by researchers at Harvard University should set those concerns to rest, according to Wes Siegner, JD, whose firm represents APHA. The public would be better served if the FDA spent more time going after "street drugs" containing ephedra than legitimate dietary supplement makers, he tells WebMD.
Despite releasing a report overwhelmingly in support of the industry position, Kimmel and other members of the panel ironically did side with the FDA on at least one issue. Given the absence of data on susceptible populations and that severe adverse events can occur in people with underlying conditions such as diabetes, further studies on the potential effects of ephedra are merited, the panel concluded.
At question now for the public at large is whether there is sufficient information to develop adequate warnings in the absence of this data, says HHS, which bills its two-day meeting as an information gathering effort, in an attempt to build a consensus.