Excerpted from ABC News, Tuesday, 8 August 2002.

Ephedra’s Effects

Regulators, Manufacturers Debate Herbal Supplement

U.S. regulators are meeting today with the manufacturers of ephedra to determine whether the over-the-counter herbal supplement is safe to use as a weight-loss drug, and whether it can affect the heart.

The battle over ephedra, which is often recommended for asthma patients, has been going on for years. Critics say the product is a dangerous stimulant that can have unpredictable consequences in some cases -- such as heart attacks or strokes. Yet millions of Americans take the supplement, believing it is an easy option to help lose weight and boost energy.

Adrian Fugh-Bermon, vice chairman of the National Women’s Health Network, told ABCNEWS that consumers should be warned if they are planning to use ephedra for those purposes. "Ephedra used traditionally for respiratory problems is not dangerous, but if used for body building or weight-loss or as an energizing sort of supplement it could be dangerous," she said.

But Dr. Stephen Kimmel, a University of Pennsylvania epidemiologist who has studied the drugs’ effects on the heart, says studies so far show the supplement may not be as harmful for weight loss as first thought.

"The pathology data available do not show any pattern consistent with ephedrine alkaloid containing dietary supplements as cause of death," Kimmel said Monday at Washington news conference sponsored by a pro-ephedra group.

Report Review

Kimmel was among a panel of experts hired by ephedra makers who reviewed 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 as directed.

Panel members acknowledged the FDA reports were hard to evaluate. Nearly three-quarters contained incomplete information. Many people involved 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, said he treated a 24-year-old woman who showed up at an emergency room suffering from a stroke that left her right side 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."

No Sound Scientific Evidence

In response to concerns, the FDA 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 today.

"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 3 billion servings were sold last year and estimate that anywhere from four million to 15 million Americans take ephedra products.

Excerpted from ABC News, Tuesday, 8 August 2002.