FDA says Avandia can stay on market despite risks
TEXT OF INTERVIEW
Bill Radke: A Food and Drug Administration advisory panel recommended yesterday that GlaxoSmithKline’s billion-dollar diabetes drug, Avandia, be allowed to stay on the market. This, despite several studies showing the drug poses an elevated risk of heart attacks. The Boston Globe’s Washingotn bureau chief, Christopher Rowland, has been following this story, he joins us live. Good morning.
Christopher Rowland: Good morning.
Radke: There’s a competing diabetes drug on the market that hasn’t been shown to pose a heart attack risk. Why did the FDA panel support Avandia on sale?
Rowland: Well there was no argument among the panel that there are signs of heart attack risk with this drug. But really what they were debating was the strength of the evidence. And at the end of a two-day hearing, a majority of 33 panel members decided that the evidence wasn’t strong enough — there wasn’t a clear-cut sign that they should take the drug off the market.
Radke: And if the FDA follows that panel’s advice, which it usually does, what are the wider implications for drug safety cases?
Rowland: I think the wider implications are that, what is going to be the standard of proof for removing a drug from the market? How high is the bar going to be? And it means that it appears that this is going to be, to get a drug off the market is going to be a really high standard of proof; these panels are going to be looking for ironclad evidence of harm.
Radke: And why does it matter so much when you’re determining safety whether a drug is or isn’t already on the market?
Rowland: Well Avandia’s been on the market for 10 years. Last year, doctors wrote two million prescriptions for this drug. You build up, there’s constituencies that build up around these drugs — doctors want it, patients want it. And especially doctors want it in case another drug may not work to control someone’s glucose levels, for example. They would like to have a second option, and that’s what happened in this case I think.
Radke: Very interesting. Boston Globe’s Washington bureau chief, Christopher Rowland. Thanks a lot.
Rowland: Thank you.
Radke: By the way, Avandia’s maker, GlaxoSmithKline, says it expects to take a $2.3 billion charge for legal costs involving Avandia and its anti-depressant, Paxil.
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