Did GSK try to quash docs' Avandia fears?

A Senate probe of GlaxoSmithKline's Avandia has turned up evidence that the drugmaker tried to shrug off doctors' early worries about the diabetes treatment. According to the Wall Street Journal, several doctors saw their concerns pooh-poohed by the company. Glaxo tried to keep two of them quiet, the story says: After two Maryland physicians raised concerns that Avandia might increase the risk of heart failure, the company wrote to their chief of staff asking that he "take immediate steps to stop the dissemination of this unsubstantiated information."

This was back in 2000. About their meeting with the drugmaker's representatives almost eight years ago, one of the physicians recalled, "They suggested we were country bumpkins, and practically said, 'Don't worry your pretty heads. We have smarter people than you looking at this, and there's no problem.'" The doctors raised their concerns at the FDA but only got a form letter in response.

As you know, last May a study published in the New England Journal of Medicine suggested that Avandia boosted the risk of heart problems by 43 percent. FDA since has negotiated "black box" warnings for the medication, including a warning that it has been linked with heart failure in some patients. Just last month, the American Diabetes Association and a similar organization in Europe diabetes advised against using the drug.

GlaxoSmithKline's spokesperson told the WSJ that its officials' response to the doctors' complaints was justified. "When GSK learns about statements by physicians that are inconsistent with the scientific data on its medicines, it has the responsibility to do what it can to correct these inaccuracies," she said. A report resulting from the Senate's probe is expected soon.

- read the WSJ story [1]

Related Articles:
'Neutral' study isn't good enough for Avandia [2]
FDA asked to pull Glaxo's Avandia [3]
Journal calls for Avandia restrictions [4]
GSK rebuked for missing Avandia reports [5]