GSK: Glaxo, Study 329 and Keller..

Study 329

                                                        Study 329.

Let me explain a little about Study 329. This was a study done in the 90s to study the efficacy of paroxetine (aka Paxil/Seroxat) in teenagers. The study was conducted by Professor Martin Keller (et al) of Brown University and funded by GlaxoSmithKline (GSK, makers of Paroxetine). The findings that Paroxetine was ‘safe and effective for adolescents’ led to the widespread medicating of children with Paroxetine and other Selective Serotonin ReUptake Inhibitors (SSRIs).

What surfaced later was that the study was in fact ghostwritten by a PR company for GSK and that far from being ‘well tolerated’ in children, Paroxetine actually caused children to become suicidal – a matter which was hidden by the drug company. If the SSRI era will stand as one of the most shameful in the history of medicine (David Healy), then Study 329 will as stand the most shameful in the history of Brown University and evidenced based medicine. The integrity of medical professionals and medical journals who publish ghostwritten articles that subsequently causes harm (in this case to children) must also be called into question. According to Shelly Jofre of the BBC, in one year alone, the lead author, Professor Keller, earned half a million dollars from drug companies, including GSK.

It’s interesting to note that the journal in question, The Journal of the American Academy of Child and Adolescent Psychiatry, has consistently refused to retract the study. Furthermore, Brown University, despite huge controversy (and huge fines for GSK), has refused to reconsider its position and back a retraction. GSK’s fraudulent marketing of Paroxetine (and other drugs) led to the largest health care fraud settlement in U.S. history – 3 billion dollars.

I wrote to the President of Brown University, Christina Paxson (in 2013), regarding the University’s inaction with Study 329. She replied:

“As you note, there have been questions raised about Study 329 for a number of years.  The U.S. Justice Department’s settlement with GlaxoSmithKline and, most recently, the decision by the editors of the Journal of the American Academy of Child and Adolescent Psychiatry not to retract the original paper have brought it back into the news. Brown University takes allegations of research misconduct very seriously.  Research integrity is a core value for Brown, and the University has put in place policies and procedures that respond forthrightly to any credible allegation of impropriety.  These policies and procedures support thorough and impartial reviews as warranted while preserving confidentiality for all participants.  I realize that the University’s concern for the integrity and confidentiality of the process can be misconstrued as inactivity.  I am satisfied that the University does not hesitate to take action when warranted.”

Hmm..

So there you have it – a little background into Study 329. So why bring it up now?

Study 329 has been re-written by a team of independent experts, including David Healy and Micky Nardo (aka 1boringoldman) et al. Having spent years trawling through the data of the original study, they have now rewritten its true findings. Yesterday, in what was a momentous occasion for parents who have lost a child to Paroxetine, the British Medical Journal (BMJ) published Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence’. 

You will be shocked to note that GSK intentionally hid the hugely increased risk of suicidality in children, subsequently causing many deaths. The re-analysed trial found that Paroxetine “is neither safe nor effective for adolescents with depression”; that at least 12 out of 93 children taking the drug had developed suicidal thoughts (Reuters); with one child being admitted due to severe suicidal and homicidal ideation towards his parents (New York Times).

I don’t like using bad language, or to be more truthful, my mother doesn’t like it (I know, I know, I’m feckin 50), yet occasionally nothing else will suffice. GSK, the absolute sociopathic ba**ards, put childrens’ lives at risk, causing many to kill themselves and leaving their parents to endure a pain and grief that no human being should ever have to suffer – for profit. Furthermore, Brown University has actively allowed this situation to continue rather than admit it was wrong. Shame on all concerned.

For more information see Restoring Study 329, Davidhealy.org and 1boringoldman.

See also GSK‘s mission statement.. ‘to help people to do more, feel better, live longer’. For the sake of my poor mother – no further comment!