8/02/2007-
"I logically can't find any way to leave this drug on the market," states Arthur Levin, director of the Center for Medical Consumers in New York. The drug Levin refers to is Avandia.
On July 31, Mr. Levin was the lone dissenting member of the US Food and Drug Administration (FDA) advisory committee that voted 22 to 1 to allow Avandia to remain on the market. The panel was made up of the FDA Endocrinologic and Metabolic Drugs and the Drug Safety and Risk Management Advisory Committees.
He is also clearly flummoxed by the panel's decision. While the panel voted to keep the drug on the market, it also made strong statements confirming the connection between Avandia and heart attacks risk.
Panel Cites Heart Attack Risks
In a 20-3 vote, the panel agreed that Avandia was tied to "increased ischemic risk", such as heart attacks in which blood is choked off from the heart. Some panel members suggested a strong "black box" warning that would focus on high-risk patients, but stopped short of a definitive rejection of the drug.
"Virtually everybody felt that there was risk," said panel chairman Clifford Rosen, a physician at St. Joseph Hospital in Bangor, Maine.
In addition to the researchers, many doctors have been increasingly prescribing other diabetes drugs instead of Avandia due to reports about health risks. One example is the diabetes drug Actos, which has not been linked to a heart-attack risk.
"If they acknowledged a serious risk in their own reports," said a Washington-based public interest advocate, "then why did they then vote to maintain the status quo by keeping the drug on the market? Avandia is not the only diabetes drug [that is effective].
"What is going on over at FDA? " she asked.
"Risk to Public Health"
While many members of the FDA panel have stated that further study is needed to determine the degree of risk, Mr. Levin doubted that further study would provide a definitive answer about the level of risk.
According to the Wall Street Journal, Levin took a stand on Avandia due to "the enormity of the potential risk to the public health"--the potential risk as outlined in the FDA panel's own documents.
The fact that several panel members advised that Avandia have a new heart-risk warning added to its label adds to speculation that the drug should have been pulled from the market.
"Clashes" at FDA
As the Wall Street Journal reports, FDA panel members "publicly clashed" with company representatives about the scientific evidence presented against Avandia. Before the vote, two drug-safety officials stated that evidence signaling Avandia's risk outweighed the drug's benefits.
Robert Meyer, director of the FDA office that reviews diabetes drugs, acknowledged he was unsure whether Avandia should stay on the market, and acknowledged a "fundamental disagreement" within the FDA on Avandia.
This is no surprise, considering the concerns raised by some lawmakers that dissent has typically been squelched at the FDA. On July 26, speaking to the Senate, Sen. Charles Grassley (R-Iowa), ranking member of the Senate Finance Committee, noted that the FDA's handling of Avandia has raised significant concerns.
"Not only did the FDA disregard the concerns and recommendations from the office responsible for post-marketing surveillance," said Sen. Grassley, "but I have found that it also attempted to suppress scientific dissent."
Avandia's Makers Respond to Decision
Chris Viehbacher, president of U.S. pharmaceuticals for Glaxo SmithKline, said it "welcomed" the panel's strong vote in favor of Avandia staying on the market.
But given the skepticism of many researchers, doctors and patients concerning Avandia's potential risks, the ultimate future of the drug is anyone's guess.
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