FDA in the Dark on GSK’s Paxil and Its Suicide Risk — Due to the Drug Company’s Maneuverings
Alicia Mundy writes on the Wall Street Journal’s Health blog:
Litigation over GlaxoSmithKline’s handling of information about the suicide risk from antidepressant Paxil has turned up some documents that say a lot about why the FDA often seems to be in the dark when problems with drugs surface. Buried in the documents was a strange exchange between lawyers suing Glaxo over Paxil and attorneys defending the company. The upshot: FDA may not even have known all the information to ask for about Paxil.
Here’s how things went down. Plaintiffs attorneys in LA got permission last year from Glaxo’s defense team to give the Justice Department access to a ton of confidential material, including the right to discuss details about it all with the plaintiffs lawyers. Glaxo had insisted previously on having them sealed in Federal Court.
Several months later, when the plaintiffs lawyers asked for permission to give the same stuff to the FDA, Glaxo’s defense team balked. On Oct. 15, 2007, Glaxo’s outside lawyers at King and Spalding in Atlanta said that the FDA had already looked at Paxil and suicide, and therefore, they wrote, “If the FDA wanted additional information, such as the internal documents you propose providing it, they could have requested them from GSK.”
