FDA Didn’t Get Paxil/Seroxat Risk Documents

From Furious Seasons:

This is just up on the excellent WSJ Health Blog. The news is that the FDA got left out of some of the documents around suicidality data on Paxil. From the paper’s Alicia Mundy:

“Here’s how things went down. Plaintiffs attorneys in Los Angeles got permission last year from Glaxo’s defense team to give the Justice Department (at DOJ’s request) 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 at Baum Hedlund 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.’

“That prompted Baum Hedlund’s Skip Murgatroyd to tell the Health Blog, ‘How the heck can the FDA ask for information they don’t have, when they don’t know about it?’ Fair point. An FDA official, who asked for anonymity, said the same thing to the Health Blog when we read the letter to him.”

There’s more to this, so go read it. As a journalist, it’s interesting to me that the Journal is all over this story while the New York Times is virtually silent.

I think Phil is right to make this last point – where’s the mainstream media reporting of all of this?


One Response to “FDA Didn’t Get Paxil/Seroxat Risk Documents”

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