Ephedra Problems Underscore Weak Regulation of SupplementsMar 18, 2003 | Minneapolis Star Tribune The debate over ephedra's safety had simmered for years. Then came the Feb. 16 death of Baltimore Orioles pitcher Steve Bechler, who keeled over from heatstroke, after taking the herbal stimulant.
Within hours of Bechler's death, the medical examiner who conducted his autopsy urged Major League Baseball to ban the herb. Sports columnists, team physicians and members of Congress took up the cause. On Feb. 28, the Food and Drug Administration (FDA) announced a ban was under consideration. Last week, the Journal of the American Medical Association called for restrictions on the herb's use.
The ephedra crusade has made the herb one of the most unpopular members of the plant world. Yet many medical experts are watching the movement with mixed feelings.
While calls for a ban are well-intentioned, many experts say that it's a mistake to focus solely on one herb. Instead, they said, ephedra should be seen as a symptom of a far greater problem in the United States the loose, sometimes haphazard regulation of all dietary supplements.
"Everybody thinks that ephedra is the only issue out there," said Richard Kingston, vice president and senior toxicologist at Prosar International Poison Center in St. Paul.
"But if it were banned today, everyone would assume there's no other lurking problems out there with supplements," he said. "That's not the case."
Ephedra, which grows wild throughout Asia and the western United States, contains a potent heart stimulant used in many diet aids and drugstore breathing remedies. The Ephedra Education Council, a supplement trade group, estimates that each year, more than 12 million Americans use the herb, also known as ma huang.
Ephedra products and other dietary supplements, which include vitamins, minerals and other medicinal herbs, are governed by the 1994 Dietary Supplement Health and Education Act. Thousands of letters from consumers wanting more access to natural medicines helped push it through Congress.
The law has been controversial. Critics contend that it lacks many safeguards required of manufacturers of prescription and over-the-counter drugs.
Supplement manufacturers are not required to prove to the government that products are safe before selling them to consumers, said Dr. Phil Fontanarosa, the medical journal editor who wrote its ephedra editorial.
Nor is there an official system to collect information about the products' adverse effects, he said. And in order for the FDA to take a supplement off the market, the government must prove the product is unsafe.
"There's almost been a double standard for dietary supplements," he said. "Here are products marketed with health claims, yet there's no need for safety and efficacy information."
Ephedra is a case study of the system's weaknesses, said Dr. Donald Hensrud, a Mayo Clinic nutrition specialist.
Although supplement manufacturers are not required to notify the government of medical problems in those taking ephedra, the FDA does keep track of voluntary reports of problems linked to the products.
About 1,300 medical problems, ranging from stomachaches to heart attacks, have been reported in ephedra users, according to the FDA.
But a report isn't proof that the herb caused the problem, Hensrud said. Nor do the reports reveal how often ephedra users have problems that might be linked to the herb. There could be many more unreported problems, he said.
"We just don't know if an herb is safe or unsafe once it's on the market," Hensrud said.
Dr. Harrison Pope, a Harvard University psychiatrist who has researched supplements, agreed and offered a different twist.
The lack of information, he said, could unfairly convict an herb like ephedra.
Although 1,300 problems may seem like a lot, Pope said that needs to be weighed against how many people use the product. A little-used supplement might produce a higher rate of problems, yet generate few complaints.
"The debate should be about how common [adverse events] are, but the bottom line is that nobody knows," Pope said. "We need more information."
This lack of data makes it hard for the FDA to prove that a supplement is unsafe a requirement if the agency tries to ban it.
The agency tried to restrict sales of ephedra products in 1997 after dozens of medical problems were linked to their use. But ephedra manufacturers countered with their own medical studies and expert testimony. The proposed ban was dropped.
The FDA's most recent action on ephedra was based on studies commissioned by the agency. One, a report by the Rand Corp., a health-care policy research organization, evaluated dozens of studies of ephedra. It concluded that the herb probably offers little benefit for weight loss and has caused some deaths.
The second study, published this month in the Annals of Internal Medicine, found that ephedra products were responsible for 64 percent of all medical problems linked with dietary supplement use.
But Kingston, the Minnesota toxicology expert, said the loose regulatory system may mean that the FDA will again have difficulty proving its case against ephedra.
The Annals study was based on reports of ephedra problems made to poison control centers, he said. Researchers did not verify the reports, he said.
"This study is being quoted everywhere, including by the FDA, as the smoking gun when in fact it really doesn't say anything," he said.
The study's lead researcher wasn't available for comment.
The ephedra industry is again marshaling experts to testify for the herb's safety and effectiveness. Already, the Ephedra Education Council is questioning the methodology of the Annals study and the conclusions of the Rand report.
Richard Price, a spokesman for the group, said dozens of studies prove that ephedra is an effective weight-loss aid. The group also points out that millions of people use ephedra, and that the 1,300 reported adverse events means problems are rare.
Fontanarosa, the journal editor, said he's convinced that there's enough valid medical evidence to ban ephedra. But better regulation would have made it easier to evaluate its potential danger.
More scrutiny of the industry also would make it easier to determine whether other herbal products are harming people, he said.
The American Herbal Products Association, another trade organization, said the 1994 law is adequate but that the FDA needs to give the supplement industry clearer manufacturing guidelines. The Ephedra Education Council has a similar stance.
Kingston, however, said a tracking system is needed now.
Already, weight-loss supplements are replacing ephedra with unproven herbal stimulants.
"This whole thing is coming to a big crescendo," he said. "It will be unfortunate only to take action on ephedra instead of using this as an opportunity to address all the concerns about supplements."