Zantac Lawsuit

Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Wednesday, August 08, 2012

Glaxo's Andrew Witty and Paxil 329

Two recent articles grabbed my attention of late, both are brilliantly written, both drag up the Paxil 329 study once more.

Jonathan Leo, Ph.D. - wrote, 'Study 329′s Authors: Should Those Who Live in Glass Houses Throw Stones?' Whilst Paul Basken penned, 'Academic Researchers Escape Scrutiny in Glaxo Fraud Settlement'

Both are well worth the read.

Both got me thinking.

With Glaxo Chief, Andrew Witty, blaming everyone but himself for the abhorrent way his company, GSK, hid the Paxil suicide link in children I can only assume that the fraudulent marketing by his company would be something he wants to obliterate from his company.

There have been calls for the academics involved in the shameful Paxil 329 study to be criminally prosecuted. The study, headed by child psychiatrist, Martin Keller, was actually written by Glaxo. Keller, along with other key opinion leaders, added their names to the paper to make it look like they had each played a part in testing the safety of Paxil in kids. Truth is, they didn't.

Truth is Paxil wasn't safe for children to take.

Keller and the rest of the 'experts' have to live with that.

The study itself was, after being passed around for three years between child psychiatrists, lawyers and PR firms, published in 2001 by the Journal of the American Academy of Child and Adolescent Psychiatry. Calls for it to be removed/retracted have been ignored by the journal.

Now, if Glaxo chief, Andrew Witty, had indeed been ashamed by his company's recent $3 billion payout for illegally promoted, among other drugs, Paxil, then surely it's down to him to contact the Journal of the American Academy of Child and Adolescent Psychiatry to ask them to retract the offending fraudulent study?

I'd like to give Witty a helping hand here. His company, Glaxo, haven't really done anything to help me or the  thousands of others wean off their addictive Paxil but, hey, you don't give to receive, right?

With this in mind I've devised a letter for Witty to simply sign and send off to the American Academy of Child and Adolescent Psychiatry.

All you have to do is sign it Witty. [Just print off and send to the journal, there's a good chap.]

For those, like me, who can't read small print, here's the letter in full:

Sir Andrew Witty
980 GreatWest Road

Dear, Journal of the American Academy of Child and Adolescent Psychiatry,
It is with great regret that I have to report that a study, A Multi-center, Double-blind, Placebo Controlled Study of Paroxetine and Imipramine in Adolescents with Unipolar Major Depression- Acute Phase, sent to you under the guise of many highly thought of and influential psychiatrists, is actually false and misleading and could potentially cause harm to the patient population it was supposed to protect... children and adolescents.
The company I am now chief executive of, GlaxoSmithKline, have recently plead guilty and paid $3 billion as part of this criminal and civil resolution. 
We agreed to plead guilty to three misdemeanor violations of the Food, Drug and Cosmetic Act.
Regarding Paxil, we agreed to plead guilty to distribution of a misbranded drug due to false and misleading labeling, we also agreed to plead guilty to distribution of a misbranded drug due to inadequate directions for use, that drug was called Wellbutrin, you may know it as Zyban, that's down to me and my former role as VP Manager back in 1997... those were the days. Anyway, I digress, we also agreed to plead guilty to failure to report data to the FDA the adverse effects our diabetes drug, Avandia, was having on people. I heard a ripple that some folk died whilst taking this drug but I don't believe in anecdotal reports.
Anyway, back to the study.
We conducted three placebo-controlled clinical studies to study Paxil’s safety and efficacy in treating depression in patients under age 18. In all three studies, we failed to demonstrate efficacy on the endpoints identified in the study protocols.
Because of this we hired a contractor to write an article on one of the studies [329] that was published in July 2001 in your journal.
The article stated that Paxil "is generally well tolerated and effective for major depression in adolescents." The article did not explicitly state that the study failed to demonstrate efficacy on either of its two primary endpoints or on any of the secondary endpoints that had been identified in the study protocol. We kind of thought that if we would have mentioned that it had failed  demonstrate efficacy on either of its two primary endpoints or on any of the secondary endpoints then we would not have been able to have a fair fight with Eli Lilly, who, at the time, were winning the antidepressant war with their particular poison, Prozac.
The study that our article referred to wasn't in fact written by any of the names that appear on it, namely, Martin B. Keller,  Neal D. Ryan, Michael Strober, Rachel G. Klein, Stan P. Kutcher, Boris Birmaher, Owen R. Hagino, Harold Koplewicz, Gabrielle A. Carlson, Gregory N. Clarke, Graham J. Emslie, David Feinberg, Barbara Geller, Vivek Kusumakar, George Papatheodorou, William H. Sack, Michael Sweeney, Karen Dineen Wagner, Elizabeth B. Weller, Nancy C. Winters, Rosemary Oakes, and James P. McCafferty.
I realize that by coming clean on this I am bringing into dispute the names of those above, who, for years, have all claimed that they played a part in the study. In fact the whole thing was drafted by Sally Laden, an editorial director for Scientific Therapeutics Information. You may have already seen the leaked memo from my company that sees the apparent lead author of the study, Martin Keller, write to Sally with, "Dear Sally, You did a superb job with this. ... It is excellent. Enclosed are rather minor changes from me."
As you may be aware, Martin Keller, or Marty as I like to call him, has gone on to earn vast amounts of money sitting on Advisory Boards for various pharmaceutical companies who want their antidepressants given that golden hallmark. Many others in the list have faced the wrath of a growing army of patient advocates/bloggers too. Poor old Stan Kutcher took a hammering a while back and subsequently failed to get elected in Novia Scotia, Canada. Karen Wagner seems to be doing well, although I understand she's under close scrutiny for a paper she wrote [ahem] about the safety of another antidepressant apparently being safe for kids, despite a previous study claiming that it wasn't. Neal Ryan made himself look rather silly when he was confronted by that Scottish bint, Shelley Jofre, from the BBC whilst the others have been pretty good at deflecting questions about their role in writing our study.
Many children have died by suicide whilst taking our drug, Paxil, many of whom should have been protected by us as we, as a caring company, had a duty to protect the most vulnerable. Alas, we failed and we failed on a huge scale.
Well, it's time to push that era away and to start making amends. So please could you retract the Paxil study from your journal and maybe offer an apology on my part for all the kids that have died since its publication. Although we can't say for sure that they carried out killing themselves because they were taking our drug, we still can't rule it out.
Sorry for any inconvenience this may cause you but I'm turning over a new leaf to get the public believing in GlaxoSmithKline again. I'm even going to blow the lid on my own past as VP Marketing Manager, that's if that pesky whistleblower, Greg Thorpe, doesn't beat me to it.
I hope to hear from you soon.
Please remember to to do more, feel better and live longer.

Yours sincerely,
Sir Andrew Witty






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