February 07, 2008

Glaxo Hid Suicide Data In Paxil Studies

That's the angle the New Scientist takes on recently released court documents from a lawsuit against Paxil's maker, GSK.

"An analysis of internal GSK memos and reports, which were released to US lawyers seeking damages, suggests that the company had trial data demonstrating an eightfold increase in suicide risk as early as 1989. Harvard University psychiatrist Joseph Glenmullen, who studied the papers for the lawyers, says it's 'virtually impossible' that GSK simply misunderstood the data - a claim the company describes as 'absolutely false.'

"Glenmullen's report rests on documents obtained by lawyers in Los Angeles, who are bringing around 30 cases against GSK linking suicides and suicide attempts to the use of Paxil. The report was under seal at a district court in Sacramento, California, until 18 January, when the judge agreed to make parts of it public."

GSK did not alert the public about increased suicidality around the drug's use until 2006. You can read the rest of the article to see what trickery GSK was allegedly up to. You can also click on a link there and view the court documents.

It'll be interesting to see how this trial plays out. I congratulate the judge for making the documents public. More judges need to follow his or her example.

Most readers know that I had some nasty experiences on Paxil in 1994, ones that were so unacceptable to me that I told my doctor that I was coming off the drug with or without his approval. It was the first time I'd stood up for myself that way with a doc. One of those things in life that you have to do.

I am so weary of pharma companies hiding data from anti-depressant studies that there's very little I can say that would not come off as deeply bitter and angry concering this news. I don't feel like going there today. But I welcome your thoughts.

Much credit to Pharmalot for having this up first.

Posted by Philip Dawdy at February 7, 2008 12:05 AM
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Comments

In 1999 one of my daughter's classmate was rx Paxil for "social anxiety" at age 11. At Summer camp, he attempted to jump off of a cliff. He was already on Adderall and Ritalin for ADHD. What if he jumped?

I am SICK of this hidden data BS.

My friend and I had black outfits in our closets ready for a funeral because of this shit.

We had no idea back then, in 1999 that medication was culprit to suicidal ideation/attempts. I don't care what the LP thinks of these black box warnings, come on, ppl including myself experienced unreal thoughts not the norm--for me it was Prozac.

I never even told the doc I was going off of it; I flat out told the [PCP] that he was killing me with his rx combo for anxiety.

Posted by: Stephany at February 7, 2008 09:02 PM

I am angry at the scientists who knew of the problem and did nothing!

Posted by: Dr. Sanford Aranoff at June 28, 2008 03:48 PM

Just to be fair to the scientists...

The clinical study team and requisite management should be under the spotlight here. I wouldn't call them scientists. Clinical is a process driven organization, little room for actual science (maybe in Phase 1, but I'm stretching....)

Posted by: Paul at June 28, 2008 05:52 PM
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