- The Washington Times - Friday, February 28, 2003

WASHINGTON, Feb. 28 (UPI) — The federal government moved Friday toward issuing new restrictions on dietary supplments containing ephedra, including requiring warning labels, as officials warned the products could cause health problems and even death.

The announcement came as a congressional committee sent a letter to the Food and Drug Administration signaling it was going to investigate the safety of ephedra supplements and requesting the agency turn over internal documents.

The House Energy and Commerce Committee said it was prompted to examine the safety of ephedra supplements — promoted as sports and weight loss enhancers — because of reports they were taken by Baltimore Orioles pitcher Steve Bechler when he died earlier this month.

A review of more than 19,000 cases of people experiencing health problems, such as stroke, heart attacks and even death, after taking ephedra suggests the products "may present a significant and unreasonable risk of illness and injury," Health and Human Services Secretary Tommy Thompson said during a news briefing.

"Therefore, the (federal government) is going to take the following steps of building the case for further regulatory action under the law," Thompson said.

The agency will "seek public comment on the health risks associated with ephedra in order to establish an up-to-date record to support new restrictions on ephedra products," he said. Thompson did not specify what the restrictions might be.

HHS also will "propose and seek public comment on a brand new and strong warning label on any ephedra products that continue to be marketed," Thompson said. The warning label, which would caution "about possible death," would appear on the front of ephedra products, he added.

The warning label also would warn about the risk of heart attack, seizure and stroke, FDA said in a written statement. It would warn "the risk can increase with the dose, with strenuous exercise, and with other stimulants such as caffeine; specifies certain groups (such as women who are pregnant or breast feeding) who should never use these products," the agency said.

The Council for Responsible Nutrition, a group representing dietary supplement manufacturers, maintained that ephedra products are safe.

"We have identified a set of conditions of safe use," John Hathcock, CRN's vice president of scientific and international affairs, told United Press International.

These safe conditions include "dosage limitation, duration of use limitation, exclusions of certain individuals such as those with hypertension … and warning labels that clearly lay all those out," Hathcock said.

He said CRN is "willing to consider" the new warning labels proposed by Thompson.

HHS's action was prompted by a petition filed in 2001 by the consumer watchdog group Public Citizen urging the government to ban ephedra products.

Public Citizen said ephedra had caused more than 100 deaths and more health problems such as stroke, heart attacks and seizures than all other dietary supplements combined.

Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, criticized HHS and FDA for failing to ban ephedra products.

"Proposing a warning label instead of a ban guarantees additional deaths and permanently disabling injuries to unsuspecting users," Wolfe said in a written statement. "There is nothing on the proposed label that will assure that more people will not die or be injured since many such adverse events have occurred in people who are not strenuously exercising and who are using the recommended doses."

Last June, HHS delayed making a decision on Public Citizen's petition, saying it needed more scientific evidence of the effectiveness and health risks of ephedra products. The agency commissioned The RAND Corp., of Santa Monica, Calif., to conduct a review of scientific studies on ephedrine compounds used in dietary supplements.

The RAND study originally was scheduled to be completed last fall but HHS said it just received it Friday.

"With regard to catastrophic events, these findings are a strong signal that there is a link between use of ephedra or ephedrine and the occurrence of death, heart attack, stroke, seizures, and serious psychiatric symptoms," Paul Shekelle, the RAND and veterans affairs physician who headed the study, said in a written statement.

"It is more likely than not that there is a relationship, although the available evidence falls short of the conventional level of scientific proof," Shekelle said.

The study, according to Thompson, concludes there are no studies showing the products improve athletic performance. The FDA said it now will crack down on companies that market ephedra products as enhancing sports performance.

There is some evidence of "modest weight loss of 2 pounds per month seen in four small studies (of people taking ephedra), but no evidence of sustainability of that weight loss," Thompson said. "Achieving that weight loss would require taking more milligrams than what FDA would recommend."

"We are particularly concerned about the risks of using products containing ephedra during heavy workouts, with caffeine and other stimulants, in a diet program that stresses the cardiovascular system, or by people under the age of 18," FDA Commissioner Dr. Mark B. McClellan said. "We are also concerned about potential stresses to the body caused by the long-term use of ephedra."

The RAND report "also says it requires further science," a frustrated Thompson said.

He noted the law has placed a "very tough burden" on the federal government for removing an unsafe dietary supplement from the market. Under the law, dietary supplements do not first have to be proven to be safe before they are sold and the FDA must show supplements are unsafe before taking it off the market.

"It is surprising to me that drugs have to prove their safety in order to get approved, (but) dietary supplements, on the other hand, we have to prove they are unsafe in order to get them off the market," Thompson said.

It is estimated nearly 2 billion doses of dietary supplements containing ephedra are sold to 12 million users in the United States every year.

The letter House Energy and Commerce Committee Chairman Rep. Billy Tauzin, R-La., and ranking member Rep. John Dingell, D-Mich., along with other committee members sent to the FDA requested the agency turn over all records of its review or analysis of adverse event reports associated with ephedra products from 1998 to the present.

The committee said FDA "has received more than a thousand adverse event reports relating to individuals using botanical ephedrine alkaloids, including numerous deaths."

The committee urged the agency to place a warning label on ephedra products.

"Because existing evidence suggests that use or misuse of botanical ephedrine alkaloids may cause serious, life-threatening conditions, we would urge you to immediately consider requiring all such products to bear a warning label," the committee letter stated.

The committee also sent a letter to Cytodyne Technologies of Manasquan, N.J., the manufacturer of the ephedra supplement Xenadrine RFA-1, which Bechler is reported to have taken the morning before his death. The Broward County medical examiner said the supplement "may have contributed to his heatstroke-related death," according to the letter.

In the Cytodyne letter, the committee said it appears the company has conducted or commissioned several studies supporting the safety of its products but at the same time has introduced a new supplement, Xenadrine-EFX, that is ephedra-free.

"This raises questions about whether your company is seeking to replace ephedra-containing products and why you decided to develop an ephedra-free alternative dietary supplement," the letter stated.

The committee requested Cytodyne report whether it has received consumer complaints or lawsuits about adverse health events associated with Xenadrine RFA-1. The company also was ordered to turn over "all records relating to the safety and/or health effects of ephedra supplements, including, but not limited to, records concerning the health effects of Xenadrine RFA-1 in general and the Bechler case in particular."

The committee cited a recent study published in the Annals of Internal Medicine, which was not included in the RAND report, that compared the safety of ephedra supplements to other herbal supplements and concluded "the relative risk for an adverse reaction from ephedra supplements was more than 100-fold higher compared with all other herbs."

In addition, a 1999 report by the General Accounting Office reviewed the scientific literature on ephedra and "found evidence suggesting ephedrine alkaloids could increase blood pressure in persons with normal and high blood pressure; predispose certain individuals to tachycardia (rapid heart rate); and, cause cardiomyopathy (disease of the heart muscle), stroke, and myocardial necrosis (death of cells in the heart)," the committee letter said.

Cytodyne did not return phone calls from UPI seeking comment.



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