By AP Business Writer
updated 7/13/2010 7:12:41 PM ET 2010-07-13T23:12:41

The diabetes pill Avandia has been used by millions of patients and racked up billions in sales in more than a decade on the market. This week the Food and Drug Administration is trying to answer a seemingly simple question: Does it cause heart attacks?

It's the type of crucial safety question that the agency was established to answer. But as the FDA began a two-day meeting Tuesday to determine Avandia's fate, it became clear that the agency's own scientists are divided.

On Wednesday the FDA will ask a panel of advisers to untangle the mess of data that has stumped its own scientists for over three years.

The group will vote on recommendations, including possible withdrawal of the drug. The FDA will make a final decision in coming months.

Copyright 2010 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Video: FDA debates safety of Avandia

  1. Transcript of: FDA debates safety of Avandia

    BRIAN WILLIAMS, anchor: There is a report circulating tonight that the drugmaker GlaxoSmithKline has agreed to pay $460 million to settle most of the lawsuits connected to its one-time blockbuster diabetes drug Avandia . The company isn't commenting on that report tonight, but it comes on the very same day an FDA advisory committee started hearing evidence on whether Avandia is so unsafe it should be pulled off the market altogether. Our report here tonight from NBC 's Tom Costello .

    Unidentified Man: I will now call the meeting to order.

    TOM COSTELLO reporting: Day one of a two-day, high stakes meeting into whether the diabetes drug Avandia is too dangerous to stay on the market. It began with the FDA commissioner urging the advisory panel to follow the science.

    Dr. MARGARET HAMBURG (FDA Commissioner): My advice is that you keep an open mind, apply your sharpest scientific thinking.

    COSTELLO: With 24 million Americans suffering from diabetes, Avandia had been the most successful diabetes drug on the market until evidence of increased rates of heart attacks , stroke and death. Members of Congress today said for 11 years the company hid documents that showed an elevated heart attack risk. But GlaxoSmithKline says those documents were taken out of context and insisted again today Avandia is safe.

    Dr. MURRAY STEWART (GlaxoSmithKline): And should remain a treatment option for patients with type 2 diabetes.

    COSTELLO: But when the FDA reviewed the company's research showing Avandia as safe, it found the research wasn't believable.

    Dr. DAVID GRAHAM (Food and Drug Administration): You can't trust it. And if we do trust it, we're engaging in the willing suspension of disbelief .

    COSTELLO: With conflicting studies showing varying death rates, Cleveland Clinic cardiologist Dr. Steven Nissen decided to do his own review.

    Dr. STEVEN NISSEN: The Avandia situation has gone on far too long. Many people have been harmed during the period of time this drug has been on the market.

    COSTELLO: Today Dr. Nissen told the FDA that 56 studies involving more than 35,000 patients have shown a 28 to 39 percent increase in heart attacks for patients on Avandia . For the director of Mount Sinai 's diabetes center, the evidence is clear enough.

    Dr. TRACY BREEN (Mount Sinai Medical Center): I probably won't be prescribing Avandia anymore and will probably be counseling some patients to come off it or consider other therapies.

    COSTELLO: The advisory panel is expected to make a recommendation tomorrow, a final decision coming after that. Three years ago it voted to put a warning on every bottle of Avandia . Now the pressure's mounting to pull Avandia altogether. Tom Costello, NBC News, Washington.


Discussion comments


Most active discussions

  1. votes comments
  2. votes comments
  3. votes comments
  4. votes comments