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Risks Of Glaxo Diabetes Drug Still Unclear: FDA
  June 6, 2007
Filed at 8:15 p.m. ET
WASHINGTON (Reuters) - The potential heart risks of GlaxoSmithKline Plc's diabetes drug Avandia are still not clear, the head of the U.S. Food and Drug Administration told lawmakers who questioned the agency's oversight of the widely used pill on Wednesday.
At a House of Representatives committee hearing, Democrats asked why the FDA had failed to request a study years ago that would have shed more light on Avandia's effect on the heart.
Republicans, meanwhile, said the spotlight on the drug was political rather than scientific.
FDA Commissioner Andrew von Eschenbach said all studies to date "are inconsistent and conclusions are not clear" on Avandia's possible contribution to heart attacks.
"That means FDA is not at present justified in taking additional regulatory action or recommending that patients stop using it," he told the House Oversight and Government Reform Committee.
Von Eschenbach did say the agency has asked for a stronger "black box" warning about another heart risk -- congestive heart failure -- on the labels of Avandia and Actos, a competitor made by Takeda Pharmaceutical Co. Ltd. <4502.T> . Both drugs now have a less prominent warning about that risk.
"Despite these existing warnings, these drugs were being prescribed to patients with significant heart failure," von Eschenbach said.
Takeda said it would add a boxed warning. Glaxo said it was discussing the request with the FDA.
A furor erupted last month when a Cleveland Clinic analysis linked Avandia to a 43 percent higher chance of having a heart attack. The study sparked an outcry from lawmakers who are considering legislation to improve the FDA's drug safety monitoring.
Millions of patients take Avandia, and sales topped $3 billion last year. But total prescriptions have fallen nearly 25 percent between May 18 and June 1, according to Verispan data. Total prescriptions for Actos have risen nearly 14 percent.
Glaxo shares fell 44 cents on Wednesday to close at $51.46 on the New York Stock Exchange. They are down nearly 11 percent since the Cleveland Clinic study was issued on May 21.
Lawmakers are not trying to decide if Avandia might do more harm than good, said committee chairman Rep. Henry Waxman.
"I'm interested in why ... eight years after Avandia's approval for market that doctors and their patients still don't have a clear answer," the California Democrat said.
He said the FDA had failed to request a post-marketing study that would determine Avandia's cardiovascular risks, as an agency reviewer had suggested.
Republicans, however, said Democrats rushed to hold a hearing despite inconclusive data and were sensationalizing the issue for political gain.
"This does look like, in fact, this was a political concoction to anecdotally go after a company rather than to do legitimate oversight on the FDA, and I object to it," said Rep. Darrell Issa, a California Republican.
Some Republicans questioned the motives of Dr. Steven Nissen, the Cleveland Clinic cardiologist whose analysis raised alarms about Avandia, noting he had contacted members of Congress about his concerns before his study was published.
"This is about patients. It's not about politics," Nissen said, adding he considered not publishing his findings but felt obligated to warn the public.
The committee also heard from a diabetes expert who raised questions about Avandia's possible heart risks in 1999 and said he was quickly targeted by some employees of SmithKline Beecham, now a part of GlaxoSmithKline.
"It was mentioned on two occasions that there were some in the company who felt that my actions were scurrilous enough to attempt to hold me liable for a loss in market capitalization," said Dr. John Buse, incoming president of the American Diabetes Association.
Buse said he later "signed a clarifying statement drafted by" SmithKline Beecham.
Glaxo said it had discussions with Buse at the time and regretted if he felt any employees acted in a way contrary to open, scientific debate.
Glaxo aggressively moved to defend itself ahead of the hearing, releasing two studies it said backed Avandia's safety and taking out at least a dozen full-page U.S. newspaper ads.
Lawmakers spent less time questioning Glaxo's research and development chairman, Moncef Slaoui, than other witnesses. Slaoui repeated that the data showed Avandia was as safe as other diabetes drugs and the company had shared information with regulators.
"I think we did the right thing," he said.
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