The Avandia Drug Dilemma
Monday, July 30, 2007SUSIE GHARIB: A mixed verdict on Glaxosmithkline's anti-diabetes drug Avandia. An FDA advisory panel concluded late this afternoon that Avandia does increase the risk of a heart attack. But the panel of outside experts refused to recommend pulling the drug from the market. Instead it's calling for increased warnings to patients and doctors. Darren Gersh reports.
DARREN GERSH, NIGHTLY BUSINESS REPORT CORRESPONDENT: Food and Drug Administration researchers told a panel of outside experts they had carefully reviewed tens of thousands of pages of studies on Avandia. A statistical overview showed the anti-diabetes drug increases the risk of a heart attack in a diabetes patient from around 2 percent in a given year to close to 3 percent. That was enough to trouble advisory panel Chairman Clifford Rosen and all but a handful of his colleagues.
CLIFFORD ROSEN, CHAIR, FDA ADVISORY COMMITTEE: I think there is a signal. I think I'm quite concerned about that signal and I think the meta-analysis do provide some level of concern for us as a committee.
GERSH: Two FDA doctors urged the panel to recommend pulling the drug off the market. But the outside experts instead followed the advice of Robert Meyer, head of the FDA's office of new drug evaluation, who said head to head trials did not show Avandia was riskier than other diabetes drugs.
ROBERT MEYER, DIRECTOR, FDA OFFICE OF NEW DRUG EVALUATION: Simply having drug choices is worthwhile for a disease where multiple drug treatment is common and patients do not uniformly either respond to or tolerate any given agent.
GERSH: Glaxosmithkline has insisted all along that the risks of taking Avandia are outweighed by the benefit of lowering blood sugar in diabetics. Chris Viehbacher is Glaxo president of U.S. pharmaceuticals.
CHRIS VIEHBACHER, PRESIDENT, US PHARMACEUTICALS, GLAXOSMITHKLINE: Avandia has been shown to do that over a five year period. None of the other existing medicines have shown that and when you compare the safety of that, then you can say, well, we stand confidently behind Avandia.
GERSH: Avandia accounts for 6 percent of Glaxo's sales and analyst Heather Brilliant says the company should be able to weather this controversy. If the FDA ultimately decides Avandia can stay on the market, Brilliant says sales won't recover immediately.
HEATHER BRILLIANT, PHARMACEUTICAL ANALYST, MORNINGSTAR: In order to counter the negative perceptions that surround Avandia now, Glaxo would need to complete a long-term efficacy study that would basically show that Avandia is worth taking despite the risks that have been raised.
GERSH: Today's advisory panel recommendation is just that: advisory. The FDA must still make the final call and given the conflicting evidence and controversy over Avandia, it's not expected to be an easy one. Darren Gersh, NIGHTLY BUSINESS REPORT, Gaithersburg, Maryland.
