Ephedra Serious Side Effects. Congress launched a wide-ranging investigation of a popular dietary supplement Wednesday, with several influential members saying they would insist on tighter controls over the product, which has been linked to reports of 100 deaths and thousands of serious side effects.
The Bush administration joined the call. Health and Human Services Secretary Tommy G. Thompson said the Food and Drug Administration is “somewhat hampered” by a 1994 law that leaves dietary supplements largely unregulated.
Speaking at the first of two days of hearings on the dietary supplement ephedra, House Energy and Commerce Committee Chairman W.J. “Billy” Tauzin, R-La., said, “If [manufacturers] don’t clean up their act, I can promise you we will.” Ephedra has millions of users, especially among young people seeking to lose weight or build muscle.
The committee is scheduled to hear today from FDA Commissioner Mark B. McClellan, who in a July 14 internal memo said his agency is pursuing “significant new enforcement actions.”
products containing ephedra
The FDA earlier this year called for stronger warning labels on products containing ephedra, and McClellan is expected to amplify on his plans during his testimony.
Several committee members criticized the FDA Wednesday, saying it has not been aggressive enough in protecting consumers from the side effects of ephedra, which range from nausea to strokes to death.
But others, reflecting Thompson’s view, said the 1994 law makes it difficult for the FDA to remove dietary supplements from the market, even if they are considered dangerous. “At best, the FDA has a dull set of instruments to work with,” said Rep. Greg Walden, R-Ore.
Rep. John D. Dingell, D-Pa., found many to blame. “I believe that because of a combination of weak statutory language, clever uncovering of legal loopholes and shoddy enforcement, the law cannot adequately protect the public from these modern-day patent medicine peddlers,” Dingell said.
Despite a barrage of criticism, ephedra manufacturers defended their product. “The overwhelming scientific evidence is that ephedra is safe and effective when used as directed,” said Robert Occhifinto, president of NVE Pharmaceuticals in New Jersey.
Ernie and Pat Bechler of Medford, Ore., sharply disagreed. Their 23-year-old son Steve died earlier this year at the Baltimore Orioles spring training camp. Belcher’s death, which has been linked to ephedra, sparked the congressional inquiry.
Wiping tears from her eyes, Pat Belcher told the committee, “They lied to our son about this product being safe.”
“They took our pride and joy from us and his wife and baby,” Pat Belcher continued. “We need to get this off the market.”
Rep. James Greenwood, R-Pa., who presided over Wednesday’s hearing, assured the Belchers, “We would not bring you here unless we intended to take this very seriously.”
Robert Hermann, vice president of Metabolife International of California, one of the nation’s largest ephedra manufacturers, said his company does not oppose “reasonable regulation” of dietary supplements. But he added, “We ask only that it be granted in the rigors of clinical evidence, rather than the hearsay of anecdotal reports.”
Three other current or former
At least two experts said that some studies ephedra manufacturers have used are not grounded in sound science.
“However, on close examination, serious questions have been raised about the conduct and results of these studies,” Greenwood said. “For example, certain e-mails we’ve uncovered appear to indicate that one ephedra manufacturer was trying to influence the work of one of its researchers to make the study more marketable.”
Marcia Crosse, acting director for public health issues at the General Accounting Office, the investigative arm of Congress, told the committee that FDA records indicate the agency has received 15 times more complaints about ephedra than any other dietary supplement.
“While it is difficult to establish with certainty that a particular adverse event has been caused by ephedra,” Crosse said, the FDA has concluded that supplements containing ephedra “pose a significant public health threat.”
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