September 15, 2009

Glaxo Exec Suggested Hiding Negative Paxil Studies

After the first day of a trial against GlaxoSmithKline for allegedly hiding birth defects data from users of its anti-depressant Paxil, Bloomberg reports:

"An executive of GlaxoSmithKline Plc, the world’s second-biggest drugmaker, talked about burying negative studies linking its antidepressant drug Paxil to birth defects, according to a company memo introduced in trial.

"'If neg, results can bury,' Glaxo executive Bonnie Rossello wrote in a 1997 memo on what the company would do if forced to conduct animal studies on the drug. The memo was read during opening statements in the trial of a lawsuit brought by the family of an injured child."

There will apparently be many more documents--ones unseen by the FDA and Congress--introduced at this trial, so stay tuned.

After several years of revelations around Paxil and GSK, I simply don't know what to say anymore.

Posted by Philip Dawdy at September 15, 2009 01:43 PM
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Comments

The issue with this evidence is that it does not prove that GSK actively buried the research and hid the risk from regulators, clinicians and the public. If you remember, Monty Burns (aka JP Garnier), brushed aside a similar Protocol 329 memo with something along the lines of "yes, yes, people say a lot of things, but we'd never actually do anything like that".

What it proves (compliance professional's head on, again), is that there is a culture within GSK, wherein executives feel completely at ease with the idea of putting such an idea in writing. A person who wrote such a thing would presumably not be expecting to be punished for it, nor even upbraided. With compliance as my background, I find that very disturbing, indeed.

If the plaintiff wishes to make this stick, then it will need to find something that cannot mean anything other than that GSK's official (albeit unwritten), policy is to hide data that would impact the chances of a licence being issued. This is the second time (to my limited knowledge), that internal documents have come to light that demonstrate pretty much conclusively what the culture is, within GSK. Anything else can be fudged.

The Senate Finance Committee caught Burns lying red-handed, in the John Buse/Avandia scandal. The plaintiff needs to do the same thing. Hopefully, they'll get an executive to lie on oath, too, and be shown to be lying on oath.

Matt

Posted by: Matthew Holford at September 15, 2009 02:54 PM

Matthew,
What this also reveals is that not only do they feel comfortable about writing about it, they're probably doing it all the time. That memo has a "ho hum" quality to it that I find quite chilling.
Sherry

Posted by: Sherry at September 15, 2009 05:30 PM

How these kinds of inflammatory statements not be held to account? Unbelievable. Thank you for reporting on these trials. I'm glad there are diligent people like you in the blogosphere.

Posted by: sandy at September 15, 2009 06:26 PM

Sacrificing our children because of our love of money: just as the Bible predicted: "you will eat the fruit of the womb, the flesh of the sons and daughters the LORD your God has given you."

Posted by: medsvstherapy at September 15, 2009 08:34 PM

Sherry wrote:
"What this also reveals is that not only do they feel comfortable about writing about it, they're probably doing it all the time..."

Well, yes, this is the difference between certainty (or near-certainty), and probability, which is, coincidentally, the difference between the civil law and the criminal law, respectively. If it's shown that GSK has been doing this regularly (and this may be shown by a past course of conduct), then it is probable that it is still going on.

If one can demonstrate conclusively that not only is it the belief of a "few rotten apples," but in fact GSK's corporate culture to cover up negative trials (and the more executives who have evidenced their belief that this is OK, the more conclusive it is), then we're moving into the realms of the criminal law, because we've got to be looking at a largescale fraud, at the very least, if not corporate manslaughter.

But it has to be shown that senior executives believe that this is OK conduct, because they're the people who make the policy. It is not enough that a few people have done it in isolated instances - there needs to be a pattern that indicates intention, because there needs to be the necessary intent, along with the act itself.

Matt

Posted by: Matthew Holford at September 16, 2009 05:49 AM


Thanks for posting about the trial

Julie (Manie's Mom)
www.bigpharmavictim.blogspot.com


Posted by: Julie at September 17, 2009 05:38 AM
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