Avandia concerns put spotlight on FDA
New concerns over the side-effects of diabetes drug Avandia are fueling more criticism of the FDA. GlaxoSmith Kline says the drug is safe, but critics say it's another example of the federal watchdog agency dropping the ball.
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Tess Vigeland: These days, it's easy to have second thoughts about some of the prescription drugs we get for our various maladies. Were they tested long enough? Do we have all the information we should about potential side effects? Three years ago, the blockbuster arthritis drug Vioxx was yanked from store shelves after being tied to an increased risk of heart problems. Now, the diabetes drug Avandia is fueling safety worries. Its manufacturer, GlaxoSmithKline, says the drug is safe. But sales are down after topping $3 billion last year. And critics say the Food and Drug Administration has, once again, dropped the ball on drug safety.Today we have the first of two reports on what the FDA knew about Avandia and when. Here's Snigdha Prakash.
Snigdha Prakash: Avandia's safety risks came to light after a prominent cardiologist at the Cleveland Clinic analyzed some 42 studies of the drug — many done since the drug was approved eight years ago.
The analysis, published in May in the New England Journal of Medicine, showed that Avandia patients were 43 percent more likely to have a heart attack than those on sugar pills or other diabetes drugs.
Diabetics are already at high risk of heart disease, so Avandia's risks are potentially grave. Strangely, it turns out the FDA has known about these risks for years, but it didn't tell doctors or patients.
Henry Waxman, the California Democrat who chairs the House Government Reform and Oversight Committee, accused the FDA of negligence at a packed public hearing last month.
Henry Waxman: As a member of Congress, I'm not qualified to judge whether the risks of Avandia outweigh its benefits. But I do know that the millions of diabetics who have taken Avandia have not been well served by our regulatory system. Avandia is a case study of the need for reform of our drug safety's laws.
Across the Capitol, Republican Senator Chuck Grassley of Iowa agreed. He's among the FDA's fiercest congressional critics.
Charles Grassley: Why do you have to have some doctor in Cleveland look at a whole bunch of disparate type of evidence that he gets off the Internet over a long period of time? And he raises the questions about the safety of Avandia.
Long before the Cleveland Clinic cardiologist wrote about Avandia's heart risks, the FDA itself was worried. When it approved Avandia in 1999, the FDA asked manufacturer GlaxoSmithKline to keep testing the drug.
In 2005, Glaxo told the FDA that an internal analysis showed Avandia raised the risk of heart attacks. It gave the analysis to the FDA in 2006. The FDA confirmed the results by crunching the numbers itself, but maintained a public silence.
The head of the FDA, Andrew von Eschenbach, defended his agency at Congressman Waxman's hearing. He said in 2006, Glaxo also turned in a second Avandia study. This one showed Avandia was safe.
Andrew von Eschenbach: We the FDA are not looking at one slice or one piece in isolation. We're looking at every piece, and putting it together into a comprehensive decision of what the right thing to do is for patients.
The cardiologist who sounded the alarm on Avandia, Steven Nissen of the Cleveland Clinic, says the right thing to do is for the FDA to tell patients and doctors about safety problems.
Nissen's critics have cast doubts on his motives. They say he's taken a research grant from a Glaxo competitor to study a different diabetes drug. Nissen says he spoke out because he's worried about patients.
Steven Nissen: There will be other drug safety problems. Let's be clear about this. And I feel very strongly that more transparency is highly desirable.
As it happens, the Senate passed an FDA reform bill just before the Avandia story broke in May. The House is expected to do so this month. But some worry that even with the changes, the FDA won't be able to prevent future safety problems like Vioxx or Avandia.
In the wake of Nissen's article, the FDA announced Avandia should carry a stronger safety warning, but for a different cardiac problem: heart failure. It's also called a meeting of scientific advisors for later this month to get advice on how to interpret the data on Avandia's heart-attack risk.
In Washington, I'm Snigdha Prakash for Marketplace.
Vigeland: Tomorrow, the congressional fix — and why it may not be enough to prevent future drug safety-problems.
