Healthy Skepticism Library item: 13867

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Publication type: news

Mundy A.
FDA Got Left Out on Paxil Risk Documents
The Wall Street Journal 2008 Jun 20
http://blogs.wsj.com/health/2008/06/20/fda-got-left-out-on-paxil-risk-documents/

Full text:

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.

SherlockBuried 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 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.

For its part, Glaxo told us in a written statement during our reporting on
the issue: “Release of every shred of paper regarding Paxil, including every
report written by someone retained as an expert witness in litigation, would
not do anything to further the public health.”

Another Baum Hedlund lawyer, Karen Barth Menzies, told us that in 2006,
after an FDA public meeting on antidepressants, she corralled the FDA’s Bob
Temple, and said there were documents that went to the heart of the concerns
on suicidal behavior in her possession that were under seal because of
Glaxo. “I asked Bob if he could subpoena them, and he told me that would be
unusual,” said Menzies. Then, she said, he told her he’d like to ask for
them, “If I could tell him what to ask for.”

The FDA declined to make Temple available to discuss this with us.

It was “an odd conversation,” Menzies told us. “The FDA should have all this
and know what it means.” But her hands were tied, she told us.