Despite the Danger Warnings, Ephedra Sells
Thu Feb 20, 9:01 AM ET
By GINA KOLATA and WALT BOGDANICH The New York Times
Investigators say it may never be known whether the dietary supplement ephedra contributed to the death of Steve Bechler, the 23-year-old Baltimore Orioles pitcher who died of heatstroke on Monday after collapsing during a workout in the Florida sun.
But what is clear, experts said yesterday, is that ephedra can be dangerous. They said no other dietary supplement on the market had stirred as many warnings and frightening medical histories as ephedra. It has been linked to deaths, to strokes, to heart arrythmias and even to psychotic episodes.
"There certainly are a lot of reasons for concern," said Dr. Mark B. McClellan, the commissioner of the Food and Drug Administration (news - web sites), which has received more than 1,400 reports of adverse effects from ephedra. "There are a lot of adverse events associated with ephedra and ephedra products, and they do have effects on metabolic rates and heart rates."
Yesterday, Tommy G. Thompson, the secretary of Health and Human Services (news - web sites), asked by reporters to comment on ephedra in light of Bechler's death, replied, "I wouldn't use it, would you?"
But despite such warnings, ephedra is widely available in health food stores and drugstores and on the Internet and more than $3 billion worth of ephedra products are sold in the United States each year, according to Senator Richard J. Durbin, Democrat of Illinois, who held hearings last October on the use of ephedra in diet supplements.
Ephedra, like other herbal supplements, can be legally sold over the counter under a 1994 law that allows their sale unless they are shown to be unsafe. In contrast, drug makers must prove to the F.D.A. that their drugs have benefits that exceed any risks before they can market them.
Dr. McClellan, of the food and drug agency, said it was "assessing what the proper way to handle ephedra is." It has commissioned a report by the Rand Corporation, to be delivered by spring, he said.
Then, Dr. McClellan added, "you should see some prompt further action from us." If the agency identifies serious risks with the product, he said, it could insist on warning labels or even remove the supplement from the market.
Wes Siegner, a lawyer for the Ephedra Education Council, an industry group, said clinical trials had demonstrated that the substance was safe when used as directed. "You can't use these individual cases to raise more than a question," he added.
Ephedra, a stimulant derived from the Asian drug ma huang, contains a mixture of chemicals, several of which increase blood pressure and heart rate. The most powerful of these chemicals is ephedrine (also used in prescription and nonprescription drugs as a decongestant), which, like an amphetamine, stimulates the central nervous system.
On vitamin-store and drugstore shelves, ephedra is generally sold in small bottles of pills or capsules, often combined with caffeine and other substances. The bottles bear a dizzying array of labels, with names like Xenadrine RFA-1 (the pills that Bechler had been taking), Xtreme Lean and MetaboLoss. The active ingredients, like ephedrine, are typically listed in fine print on the labels in milligrams.
Uses and Side Effects
Dr. Rudoph Leibel, an obesity researcher at Columbia University, said the doses sold in supplements often provide the equivalent of 75 to 90 milligrams a day of ephedrine.
Doctors have prescribed it for weight loss, he said, but patients usually receive about 25 milligrams a day. To make matters worse, Dr. Leibel added, consumers often take even more than the supplement makers recommend. "You can get into a lot of trouble," he said.
The product Bechler took, Xenadrine RFA-1, made by Cytodyne Technologies of Lakewood, N.J., comes in capsules, each containing the equivalent of 20 milligrams of ephedrine. Consumers are advised to take four pills a day and are promised that they are getting a "revolutionary" fat burner that is "clinically proven to dramatically increase the rate of fat loss significantly more than diet and exercise alone."
Ephedra has been widely used by athletes and is banned in several sports, though not by organized baseball. In the last decade, athletes who tested positive for ephedrine or ephedra have been suspended, penalized or stripped of medals and honors in sports including track and field, swimming, gymnastics, soccer and professional football.
"I've taken it in the past," Nick Johnson, a Yankees first baseman, said. But he added that the news of Bechler's death was "scary it's very scary."
"It would be a pretty good idea to stay away from it," he said. "I want to be around for a while."
Sterling Hitchcock, a Yankees pitcher, said: "I've used it. You just have to be smart with it. I've used less than the dosage."
And catcher Mike Lieberthal of the Philadelphia Phillies told The Associated Press: "I used it for energy purposes during workouts. I stopped taking it two years ago when told the supplement could cause severe medical problems."
Ephedra can promote heatstroke in three ways, according to Neal L. Benowitz of the University of California at San Francisco. It speeds metabolism and thus creates extra heat. It constricts blood vessels in the skin, preventing the body from cooling itself efficiently. And by making the user feel more energetic and less fatigued, it keeps him exercising longer.
These effects can be especially harmful in people who are dehydrated, out of shape or overweight, Dr. Benowitz said. Bechler was 6 feet 2 inches and weighed 249 pounds, 10 pounds over his weight at the end of last season.
Dr. Harrison Pope Jr., who is chief of the biological psychiatry laboratory at McLean Hospital at Harvard, said ephedra is effective for weight loss. Virtually every female body builder he has interviewed takes ephedra, he said, and so do many male body builders.
"The reason people take it is that it has a pronounced stimulatory effect," Dr. Pope said. "The more you take, the more effect you get and the more potential fat loss you get. It is a very potent drug, it creates a mild euphoria in many and it increases appetite and increases the rate that you burn calories.
"It is common for people to take a small amount, decide it is innocuous, and then gradually escalate their dose and get into a range with significant side effects."
Researchers' Red Flags
A variety of research studies have called attention to ephedra's dangers. The most recent is to be published next month in The Annals of Internal Medicine and is available now on the journal's Web site (www.acponline.org). In it, Dr. Stephen Bent of the University of California at San Francisco and his colleagues report that ephedra is the most dangerous herbal product on the market.
The researchers, who have consulted for lawyers suing ephedra makers on behalf of injured consumers, say that 64 percent of all reports of adverse reactions to herbal supplements in the United States involve ephedra. Yet products containing ephedra represent only 0.8 percent of all herbal products sold.
"The sale of ephedra as a dietary supplement should be restricted or banned to prevent serious adverse reactions in the general public," they write.
In recent years, ephedra has come under increasing scrutiny from Congress. Senator Durbin's hearing in October focused in part on two products called Yellow Jacket and Black Beauty, both made by NVE Pharmaceuticals of Newton, N.J. Anne Marie Murphy, an aide to Mr. Durbin, noted that Yellow Jacket is the "street name for barbiturates, and Black Beauty is the street name of amphetamines."
A constituent of the senator's, a high school wrestler, died after taking Yellow Jacket, Ms. Murphy said. She added that under Congressional pressure, the company recently stopped making the two products but that it continues to market Stacker2, which contains caffeine and ephedra.
Robert Occhifinto, president of NVE Pharmaceuticals, was convicted of money laundering in the early 1990's in a scheme to supply chemicals used in the manufacture of the illegal stimulant methamphetamine, according to the federal Drug Enforcement Administration. He did not return phone calls left at the company's headquarters seeking comment.
Last month Senator Durbin wrote to Secretary Thompson of the Health and Human Services Department, asking him to ban all ephedra products.
Another leading manufacturer of supplements containing ephedra is Metabolife International of San Diego. Its founder, Michael Ellis, is under investigation by the Justice Department (news - web sites) after telling federal regulators that his company had received no "adverse incident" reports involving products with ephedra. Mr. Ellis is no longer with the company.
Ms. Murphy said Congressional investigators had recently found that 2,000 "serious adverse events" had been reported to Metabolife. And last year, an Alabama jury awarded $4.1 million to four people who suffered strokes or heart attacks after taking an ephedra-based appetite suppressant made by the company. Metabolife officials did not return calls seeking comment.
On Long Island, the Suffolk County Legislature recently passed a bill banning ephedra, the only government unit to do so. Legislator Jon Cooper, Democrat from Huntington, who led the campaign to ban ephedra, said he had to overcome a "massive lobbying campaign" mounted by companies in the county that make supplements with ephedra.
He said he expected the bill to be signed into law or vetoed within three weeks, and added that he had enough support to override any veto.
At a Vitamin Shoppe in Greenwich Village in Manhattan yesterday, the shelves of the weight management section were filled with bottles containing ephedra. There were no signs warning about any side effects on the shelves.
When asked if the supplement had any side effects, a store employee said ephedra was dangerous only for people with diabetes. Another clerk said he had heard of people taking it before going to clubs, like Ecstasy. "But a baseball player just died taking it!" a woman in line said. "They just said it on the news."
At Duane Reade on 42nd Street and Eighth Avenue, a pharmacist, Rajesh B. Kumbhani, said he was uncomfortable knowing that ephedra was readily available, given the health risks.
"I don't tell anybody that they should take ephedrine," Mr. Kumbhani said, gesturing at the ephedra next to other weight-loss products. "This is all advertising and marketing. They should take it out." |
