Paxil

Judge reverses Paxil preemption ruling

Tracy Staton — Mon, 21 Jul 2008 11:05:30 -0400

Pre-emption fans took one on the chin last week when a federal judge changed his mind. U.S. District Court Judge David Hamilton reversed a previous opinion that dismissed a Paxil suicide case, saying that FDA approval would shield drugmakers from state-court claims. In his new opinion, Hamilton wrote that he had "failed to appreciate the significance of the fact that the ongoing ability, authority, and responsibility to strengthen a label still rests squarely with the drug manufacturer."

That Paxil case--brought by a woman whose brother, a priest, shot himself 22 days after starting the drug--will be reopened. But like so many other state-court claims brought by patients, it could be rendered moot this fall when the Supreme Court hears a case widely considered to be an opportunity for the justices to confirm pre-emption.

- see the post at Pharmalot

U.S. Paxil probe broadens

Tracy Staton — Fri, 20 Jun 2008 09:20:10 -0400

More government watchdogs appear to be boarding the Paxil investigation train. The Justice Department is coordinating a probe that includes Colorado's Justice folks and the Boston U.S. attorney's office. GlaxoSmithKline had already disclosed the Colorado investigation and confirmed the rest in today's Wall Street Journal. Investigators are gathering documents and depositions about Paxil's potential link to suicidal behavior, at least in part from plaintiff's lawyers representing families suing the drugmaker, and about GSK's portrayal of those risks to doctors and the FDA, the WSJ says.

Glaxo says it's cooperating with the investigation and that it can't comment further. In the past, the company has said that it "acted properly and responsibly" in testing Paxil and passing on trial data to regulators.

According to the WSJ, the probe is particularly focused on Glaxo's submissions to the FDA about Paxil and suicidality when the drug's approval was pending. Investigators also were anxious to get their hands on some documents, under court seal, that disputed GSK's research conclusions on suicidality risks. GSK gave the Justice Department those documents, stipulating that they not be passed along to the FDA.

You'll recall that last week, Sen. Charles Grassley demanded an FDA investigation of Paxil's 1992 approval. That followed a years-long U.K. investigation that recently ended with no charges against GSK because British laws on data-sharing are unclear.

- read the Wall Street Journal story

Grassley asks FDA for Paxil review

Tracy Staton — Fri, 13 Jun 2008 10:25:02 -0400

Seemingly tireless FDA critique-man Sen. Charles Grassley now has his eye on GlaxoSmithKline. He's asking the FDA to review GSK's antidepressant Paxil, which just emerged from a years-long probe in the U.K. Namely, Grassley wants the agency to determine whether the company knew about Paxil's links to suicidality when it asked for U.S. approval, and whether GSK concealed knowledge of those risks as time went on. Grassley is also questioning a particular trial in which, he says, GSK may have assigned patients with previous suicide attempts to the placebo group to inflate suicidal behavior in that group so that the Paxil-taking group would look better. "Essentially, it looks like GlaxoSmithKline bamboozled the FDA," he said during a statement on the Senate floor.

You'll recall that the U.K. investigation--into whether GSK withheld unflattering Paxil data from drug watchdogs--yielded no criminal charges. It did lead to a public chiding from officials, who said the only reason they weren't pressing charges was because U.K. law was inadequate. Immediately MPs pledged to change the law to require drugmakers to fork over all the data they have on drugs they're submitting for approval. Grassley wonders whether U.S. law is also inadequate. "I am asking the FDA to take a look at the same information that was examined in the U.K.," he said in his letter. "And I am asking the FDA if we need to change any laws here in the United States."

- check out Grassley's release and letter
- see the WSJ Health Blog item

Garnier hangs up on BBC interview

Tracy Staton — Tue, 20 May 2008 10:18:18 -0400

The British press is abuzz today with the fact that outgoing GlaxoSmithKline CEO Jean-Pierre Garnier abruptly ended a BBC interview when it turned adversarial. Apparently, Garnier agreed to appear on the program to talk about GSK's new pandemic flu vaccine, Prepandrix. But host James Naughtie deviated from the subject, asking about the recent dust-up over Seroxat (Paxil). Garnier got increasingly agitated as Naughtie repeated the same queston--seven times!--then politely cut off the interview and hung up.

You'll recall that the U.K. government had been investigating GSK's handling of data about potential Seroxat safety problems in children; though investigators concluded the company hadn't broken the law, they said the real problem was that the law wasn't stringent enough, and scolded GSK for withholding data.

- read the item at The Guardian's TV and radio blog
- see the story in The Times
- get more from The Herald