June 20, 2008

Feds Probing Glaxo Over Hidden Paxil Suicidality Data

The Wall Street Journal has a piece in today's issue--and I can only get a snippet of it on this side of the subscription firewall--stating that the feds are widening their probe of allegations that GlaxoSmithKline hid suicidality data on Paxil for 15 years. From the paper:

"A Justice Department investigation of GlaxoSmithKline PLC's handling of its blockbuster antidepressant drug Paxil, including its marketing and safety research, appears to be widening.

"Glaxo, one of the world's largest drug makers, confirmed Thursday that a previously disclosed Colorado-based Justice Department investigation of marketing practices also includes the Boston U.S. attorney's office and is being coordinated by the agency in Washington."

Reuters thought the piece significant enough to run an account of it on its wire. From this, you can tell that several arms of the Justice Department are looking into matters and that's not happening for nothing. The feds don't discuss ongoing investigations, but it's clear that something is afoot. What's more, Glaxo has got Sen Charles Grassley (R-Iowa) poking around the same issue as well.

I'm not sure where this is all leading, but I can assure you that people like these don't waste their time on an issue like this unless they are going someplace with it and there are lots of documents floating around.

Stay tuned.

Posted by Philip Dawdy at June 20, 2008 12:05 AM
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Comments

Let's hope they can succeed where the UK failed.


A prosecution is what is needed here. People need to be named and shamed. Our MHRA wrapped the 'suspects' up in cotton wool... I think Grassley is made of sterner stuff.


Fid

Posted by: BOB FIDDAMAN at June 20, 2008 12:31 AM

I hope to see the Paxil documents here alongside the Zyprexa documents one day. (just my opinion)

Posted by: Stephany at June 20, 2008 01:57 AM

The DOJ seems to be in a prosecuting mood these days which is excellent. If only I could see some pshrinks weeping uncontrollably (clinical term depresion with psychotic episode, nos) as they are hauled into court I think my dysthemia would forever abate. Perhaps the Court should order everyone at Glaxo to take Paxil.

Posted by: Sally at June 20, 2008 03:54 AM

Good Idea, Stephany. Maybe Philip should post the Glenmullen report for starters, the one that was on Pharmalot a day or two ago. It's 134 pages of good stuff.

Posted by: Sara at June 20, 2008 07:59 AM

Heads should roll for this..
But considering the MHRA let them off the hook, I won't hold my breath for Justice in the US, but I am hopeful...


Posted by: truthman30 at June 20, 2008 10:57 AM

"Perhaps the Court should order everyone at Glaxo to take Paxil."



Oh, one can hope, Sally. Not only should they be ordered to be given Paxil, they should then be forced after a year to go on a cold turkey withdrawal.



AA

Posted by: aa at June 20, 2008 11:45 AM

Not surprised to read this. A researcher pointed out YEARS ago after Paxil first came out that since it had such a high affinity for the serotonin site (meaning it was so strongly attached to serotonin receptors versus other SSRI meds like Zoloft and Prozac) there could be more problems with it than the other SSRIs. What distanced me from Paxil were two things: the level of weight gain I saw in women, and the high level of sexual dysfunction in men. Plus the reps never could accept any criticism of their product and could be so dismissive of such comments to a point of denial and rudeness that motivated me to say "thank you and goodbye" as a single word.

My take on the suicidal issue with antidepressants as a whole: with 70% of antidepressant scripts being written by NON psychiatrists (ie PCPs/family docs/OBs), these meds were, and still are for the most part, passed out like pez and not monitored the way a mental health care provider is trained to assess and advise. People by in large with legitimate depression should be advised to be in therapy and titrate the meds in a scheduled increase that would minimize side effects and reinforce a multifactorial approach to treatment. As a therapist once shared with me:
Pills don't give you skills; talking gets you back to walking.

But, meds have a role. It would be nice if both physicians and patients would focus on the whole picture. Sadly, it is a quick fix society on a planet that does not share such a limited view globally. Can we relearn? I hope so.

Posted by: therapyfirst at June 22, 2008 01:28 PM
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