A federal government advisory panel has recommended that GlaxoSmithKline's much-maligned diabetes drug Avandia remain on the market - even after finding that it increases the risk of heart attacks.
The recommendation to the Food and Drug Administration could enable the drug company to avoid taking the financial hit that would come with halting sales of the drug. It did not end the controversy and uncertainty that has dogged Avandia for years.
Still, anything less than withdrawal of the drug is a victory for GSK, said Linda Bannister, an Edward Jones analyst who follows the pharmaceutical industry.
Avandia's critics complained that the panel's decision Wednesday ignored the evidence. Doctors who have lost confidence in Avandia say they're not changing their opinions. Dr. John Pippin, a cardiologist and senior medical and research adviser to the nonprofit Physicians Committee for Responsible Medicine, said the advisory panel's recommendation demonstrated once again that the FDA is the handmaiden of the companies it's supposed to regulate.
"It's a very high hurdle to get the FDA to recall," he said.
A divided panel
The 33-member panel of medical experts was far from unanimous, with 17 advisers recommending that the drug stay on the market, according to Bloomberg News. They did, however, recommend additional warnings about the potential for heart problems. The drug already carries a warning bordered by a black box - the agency's strongest visual cue of a drug's safety issues.
Three panelists recommended the drug remain on the market as is, while a dozen voted for a recall. One adviser abstained.
The Food and Drug Administration usually follows the advice of its panels, although it isn't required to do so. It could be months before the FDA acts. In the meantime, Avandia remains on the market.
"Following today's recommendations, we will, of course, continue to work with the FDA in the best interest of diabetes patients who face this chronic and serious disease," Dr. Ellen Strahlman, GSK's chief medical officer, said in a prepared statement.
Quintiles ensnared, too
A second major Triangle company, pharmaceutical services giant Quintiles, also was ensnared in the controversy. Durham-based Quintiles worked with GSK on a key clinical trial that attracted withering criticism from an FDA staffer who said that mishandling of data "suggest serious flaws with trial conduct."
Quintiles spokesman Phil Bridges said Wednesday that it would be inappropriate for the company to comment on the advisory panel's actions, but added: "It is important to note, however, that the FDA's Division of Clinical Investigations concluded that 'FDA inspections at clinical sites, the sponsor and the CRO did not identify any evidence ... that would undermine the reliability of the data.'" The sponsor is GSK; the CRO, or clinical research organization, is Quintiles.
Quintiles has more than 20,000 employees worldwide, including 1,400 in the Triangle.
GSK has 5,000 employees locally, and Avandia is packaged at the company's manufacturing plant in Zebulon. Withdrawal of the drug would mean a financial hit for the company as well as put it at a disadvantage in defending thousands of lawsuits that allege Avandia caused patients' heart attacks and stroke.
GSK stands firm
GSK has steadfastly maintained Avandia is safe despite a firestorm of criticism that reached a crescendo in the days leading up to the two-day advisory committee meeting.
Documents released by the Senate Finance Committee this week sparked news reports that GSK's predecessor, SmithKline Beecham, hid negative trial results linking Avandia to heart attack risks that date back to 1999.
"When drug companies withhold data regarding safety concerns about their medicines, they put patients at risk," Sen. Max Baucus, D-Montana, told The New York Times.
GSK complained that the documents were "incomplete and misleading," and that the company "has been diligent in providing its safety data on Avandia to the FDA."
The panelists took a series of votes Wednesday evaluating whether the safety risks of Avandia outweigh its benefits. The panel decided that Avandia increases the risk of heart attacks more than other diabetes drugs and, in a separate vote, found that it doesn't increase the risk of death, according to Bloomberg News.
John Buse, a professor of medicine at UNC-Chapel Hill, said the lack of a consensus on Avandia will keep the controversy surrounding it alive.
"The mystery is why doctors continue to prescribe it," said Buse, the former president of the American Diabetes Association. "Doctors aren't supposed to be divided on the question whether a drug is safe or harmful."
'No-brainer,' doc says
Henry Barsky, 67, a Morrisville retiree who underwent a quadruple bypass in 2001, stopped taking Avandia two years ago because of concerns about the drug's safety. He said the panel's decision that Avandia increases the risk of heart attacks underlines for him that he made the right choice.
"I honestly feel I made a life-saving decision," he said.
Thomas Jeffries, a family doctor in Raleigh, took about 75 patients off Avandia three years ago. He said the panel votes confirmed his concerns.
"It's a no-brainer for me," he said. "The risk of a heart attack is a pretty big problem."
Congressional critics of Avandia were not happy with the panel's recommendation.
"The result of the advisory committee vote is gravely disappointing and raises serious questions as to whether the science was presented in an unbiased manner," Rep. Rosa DeLauro, D-Conn., told The Associated Press.
Avandia was the world's best-selling diabetes pill, with more than $3 billion in annual sales in 2006. But sales took a big hit after a 2007 study linked the drug to a 43 percent increased risk of heart attacks and a strict warning about the risk was added to its label. Last year, sales totaled $1.1 billion.
The FDA advisory panel that convened Tuesday and Wednesday considered test data about the drug compiled since 2007.
Bannister, the analyst, said she expects sales of Avandia to decline slightly this year and next. In 2012, however, Avandia's patent protection is expected to expire, opening the floodgates for cheaper generics and putting a huge dent in GSK's sales.
GSK once held out hopes that Avandia could be used for other diseases as well. But clinical trial results released 12 months ago found that the drug was ineffective in treating Alzheimer's, and the company says it is no longer pursuing other applications for the drug.
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