A special advisory committee to the Food and Drug Administration has agreed that the diabetes drug Avandia can cause heart attacks. But they also say the drug should stay on the market.
So once again, the FDA is faced with a difficult decision about a popular drug. And at Monday's FDA meeting, it was starting to sound like Vioxx all over again.
FDA epidemiologist David Graham presented an analysis that suggested serious problems with the diabetes drug Avandia, also known as rosiglitazone.
"For every 114 patients that we treat with rosiglitazone for a year, we would see one extra case of serious coronary heart disease," Graham said.
Despite the criticism, manufacturer GlaxoSmithKline is sticking by its drug.
Chief medical officer Ronald Krall described three large ongoing studies of Avandia that Glaxo has sponsored. In the studies, doctors are keeping track of the number of heart attacks (myocardial infarctions).
"The number of myocardial infarctions is small, the data are inconsistent and there is no overall evidence that rosiglitazone is different from other oral antidiabetic agents," Krall said.
As it did with Vioxx, Congress has been weighing in. Since the first warnings about the drug were published in The New England Journal of Medicine, legislators have sent letters to the FDA and in June held a hearing to question the agency about why it wasn't moving more quickly to investigate the drug.
Advisory committee members for Avandia, as with Vioxx, complained that the FDA allowed the drug on the market before enough data were collected.
Monday, committee members repeatedly said the studies they had on hand really weren't enough to determine whether the risk of heart attack is real.
"I think if I were a betting person I'd probably vote for a cardiovascular risk for rosiglitazone," said David Schade of the University of New Mexico School of Medicine. "I'm not a betting person. Therefore, I think the amount I'd bet on it certainly wouldn't be my house — more likely, it would be my lunch."
So the committee hedged its bets. It voted 20 to 3 that there is some heart disease risk, especially for older people, and those on insulin or a class of heart drugs called nitrates. Yet it voted 22 to 1 to recommend that the agency leave Avandia on the market, with some sort of warning on the label about risk of heart disease.
One reason was to give doctors and patients choices of diabetes drugs, which are notoriously underused.
Charlie Steele's diabetes led to the amputation of one of his legs. He told the committee about his 83-year-old mother, who also has diabetes. She had tried other diabetes drugs, and stopped because of side effects.
She was happy at first on Avandia. Then came the news reports.
"Since May, when this became a massive news item, she hasn't taken any medications at all for her diabetes," Steele said. "That worries me. I'd rather see her on a medication with close monitoring for specific possible side effects than no medication at all."
While some people want their Avandia, others think the agency should have taken sharper action against the drug a long time ago.
Avandia has been on the market for eight years.
At a break during the meeting, FDA official Douglas Throckmorton defended his agency, saying sometimes you don't see problems until many people take a drug.
"In the end, some of this comes down to needing patients to have the drugs and see what experiences they have and collecting those experiences and trying to incorporate them into the safety pattern for the drug," Throckmorton said. "That's what we're striving to do here."
Cleveland Clinic cardiologist Steven Nissen started the public debate back in May with his analysis that found a 43-percent increase in heart attacks.
He was an early critic of Vioxx. After listening at Monday's hearing, he said he still believes Avandia has more risks than benefits. But he wasn't disappointed with the committee's vote.
"The argument was made very well for why further actions may have been appropriate, but I'm actually satisfied," Nissen said. "They in fact affirmed the finding that there's increased cardiovascular risk with the drug."
He says if the FDA goes ahead and puts a warning on Avandia, doctors will prescribe it less often. That's already started to happen. According to the company, sales of Avandia have dropped 31 percent in the U.S. since Nissen first sounded the alarm in May.