New Debate Over Weight-Loss Herb Ephedra

Manufacturers and U.S. regulators have battled for years over whether ephedra, an ingredient in dietary supplements for weight loss or boosting energy, causes serious harm in rare cases. Tuesday, both sides face off again at a public meeting to discuss whether ephedra can be linked to problems such as heart attacks or strokes.

A panel of experts hired by ephedra makers launched a preemptive strike Monday by announcing its review of nearly 1,200 ``adverse events'' in patients taking ephedra products. The reports were submitted to the Food and Drug Administration over several years.

After reviewing the FDA reports as well as other published literature, the panel concluded the information did not show a link between the herb and serious health problems if the products were taken according to standards set by top makers.

``Available information does not demonstrate an association between the use of dietary supplements containing (ephedra) and serious adverse events'' when used as directed, said Dr. Stephen Kimmel, a University of Pennsylvania epidemiologist who has studied drugs' effects on the heart.

Panel members acknowledged the FDA reports were hard to evaluate. Nearly three-quarters contained incomplete information. Many involved people who ignored manufacturers' directions, including a warning to take no more than 100 milligrams of ephedra per day, the panel said.

Some say ephedra, also listed on product labels as ma huang, can be dangerous even if taken according to industry standards. Because ephedra is a stimulant, critics say it can dangerously speed up heart beats and raise blood pressure.

Dr. Michael Hoffstetter, a Virginia neurologist, treated a 24-year-old woman who showed up at an emergency room suffering from a stroke that left her right side completely paralyzed. The woman had been taking an ephedra product for one month in order to lose some weight before her wedding, said Hoffstetter, who blames ephedra for the stroke.

``I really have no other reason for a 24-year-old healthy young woman to have a stroke,'' Hoffstetter said in an interview. ``She was taking the diet pills within their labeling. She was on them for about a month and really had no warning of this.''

In response to concerns, the Food and Drug Administration in 1997 proposed capping ephedra dosages at 8 milligrams per serving and warning consumers to take only 24 milligrams daily for up to seven days.

The FDA withdrew its proposed restrictions last March after the industry and congressional investigators charged it did not have sound scientific evidence to support them.

Now, FDA officials say they are starting over with a new review of ephedra's safety. The agency has collected 273 new reports on people taking ephedra and is scheduled to present its evaluation Tuesday.

``We're kind of starting from square one to see if we can get more scientific backing for what we might do in the future,'' an FDA official said.

Despite controversy over ephedra, the supplement's popularity has been growing since 1995. Makers say three billion servings were sold last year and estimate that anywhere from four million to 15 million Americans take ephedra products.