The FDA ordered GlaxoSmithKline to write certain physicians describing the July expert advisory panel discussion regarding the risks of Avandia, their controversial diabetes medicine. However, many are calling the letter misleading. The letter was sent to physician investigators in the Tide trial, a trial the F.D.A ordered GSK to top recruiting new patients.
Dr. David Graham, an F.D.A. medical officer, gave an impassioned presentation at the advisory meeting arguing that the study should be stopped because patients in the trial are being exploited. None of
his arguments were referenced or described in GlaxoSmithKline’s letter.
Other members of the advisory committee complained that the company’s letter was biased.
The dispute is part of an ongoing battle over what the committee actually decided in July. The committee’s most important vote was whether Avandia should remain on the market and, if so, how. Five different options were offered. Three panel members voted for no change; 7 voted to add more warnings to the drug’s label; 10 voted to severely restrict the drug’s marketing; and 12 voted that the drug should be withdrawn. One abstained.
If the drug is withdrawn, this latest dispute will disappear since the Tide trial itself would likely end.
For more on this story, see Glaxo Memo on Avandia Is Questioned (prescriptions.blogs.nytimes.com)