"We Speak for the Dead to Protect the Living."

"We Speak for the Defendants to Protect thier Profits."

GlaxoSmithKline’s Study 329 of medication for adolescent depression failed to demonstrate any benefit for paroxetine over placebo in adolescents and demonstrated a worrying profile of adverse events for paroxetine. The study was ultimately published in 2001 by the Journal of the American Academy of Child and Adolescent Psychiatry with Martin Keller as the primary author. This misleading paper has been a focus of interest for Healthy Skepticism since 2002.



In 2003 we wrote to the Editor of JAACAP raising concerns about the misleading reporting by the authors that exaggerated benefit and downplayed adverse effects. (We also questioned editorial functioning, which drew an angry response from the Editor).



In 2004 CMAJ published an Editorial which showed that in 1998 an internal GSK document clearly acknowledged that GSK were aware that 329 was negative. A subsequent law suit by New York Attorney General, Eliot Spitzer, was settled out of court.



In 2006, we wrote to the Lancet to point out that internal documents from another United States law suit (Smith versus GSK) revealed further concerns about study 329: -



The study was ghostwritten.



Misleadingly positive interpretations of the study were promoted to drug reps and other GSK staff.



An illusion of efficacy was achieved by re-inventing primary and secondary end points.



Eventually GSK had to acknowledge the failure of all three of their child and adolescent paroxetine depression studies.

Fid

June 7 2007Yesterday saw the start of the "Death by Paxil" inquest involving Sara Carlin.The inquest was called for after Sara, a bonny teeneager from Oakville, Toronto, took her own life by hanging herself in the basement of her parents home on Sunday, May 6, 2007.The motto for the Office of the Chief Coroner of Ontario isIn other words, the coroner will review the circumstances around the death of a person in hopes that similar deaths can be prevented in the future.As events unfolded on day one of Sara's inquest, one cannot help but feel that the Office of the Chief Coroner of Ontario's motto should be changed to,It would appear that the Carlin’s are up against not only the might of GlaxoSmithKline's lawyers & the doctors lawyers but also the coroner’s lawyer Michael Blain.At the start of the inquest the Carlin’s lawyer, Gary Will, made a motion asking that the family be allowed to question the coroners witnesses last, a privilege usually afforded the family in an inquest, for obvious reasons.They were denied this motion as the coroner ruled that the doctors go last and the family first. This is the first ruling of many expected against the family.The coroner counsel Michael Blain, when examining the pathologist Dr. Fernandez, was sure to ask the pathologist to describe in detail the stretching of Sara’s neck as a result of hanging.This seems a strange request, and one that the Carlin's, who are still mourning the loss of their daughter, should not have to endure.As far as I am aware this inquest is to try and determine what caused Sara to hang herself and not the state of her neck after she had tied a piece of electrical wiring around it.One would assume that the Carlin's were already aware of the state of Sara's lifeless body, in particular Neil, her father, who found Sara's body back in May, 2007.Quite why the Coroner Council, Michael Blain, is taking this route is unknown. As someone on the outside looking in, it would appear that it's some sort of tactic used to deter other families requesting inquests.I think the Carlin's already have the vision and state of Sara's neck firmly implanted in their minds. To raise this again serves no purpose, as far as I can make out, particularly when the Carlin's requested the inquest to try and determine the cause of their daughter's death and not how far her neck had been stretched as a result of her hanging herself.Two schools of thought spring to mind here. Will the Coroner Council, Michael Blain, later suggest that Sara's death was a result of an accident, a prank gone wrong?Or, is this merely a punishment for the Carlin's? They, after all, are questioning the whole of the medical profession and regulatory authorities here. Is this some kind of payback for them daring to question authority?Not content with this, Blain then, during a short recess in the proceedings, went in front of TV camera's and claimed that expert evidence to be given later in this case will show that Paxil was not related to Sara Carlin's suicide.I find this utterly amazing and totally biased.The Coroner's Office is supposed to be neutral and supposed to protect public safety. It is supposed to give the dead a 'voice'.An inquest serves an investigative, social and preventative function. It involves public scrutiny of the conditions which may cause or contribute to the death of a member of the community.It would appear that the Coroner's Office have already made their mind up regarding the causation of Sara Carlin's death. Day one and already they are talking to the media claiming that evidence will be shown that Paxil did not cause Sara's death.One cannot help but feel that the jury present at this inquest will later go home, switch on their TV's and see a talk-show host look-a-like with a missing front tooth [Blain] announce that evidence [that they, the jury, shall later see] will prove that Paxil did not cause Sara's death.I intend to write about this inquest on a daily basis. If the Coroner Council wants to stifle the voice of Sara Carlin then my intention is to allow Sara a voice, a voice that the Office of the Chief Coroner of Ontario promise if their motto is anything to go by - "We Speak for the Dead to Protect the Living."Blain's vain attempt to sway a jury decision at this stage is not speaking for Sara Carlin. It is not serving the public interest either - Put me in front of a TV camera and I'll say the same thing.The last witness of the day described to the jury Sara before Paxil as being brilliant in everything she did, sports, school - and loved by all who knew her.The Carlin’s are in for a rough ride with all sides including the coroner against them. Lets hope the jury see through all of this and see how dangerous Paxil can be when prescribed to children and teenagers.In the interest of balance... or to rebut the outlandish statement made by Michael Blain in front of the media - I would like to direct interested parties to the Paxil 329 studies. In short, these studies will show how GlaxoSmithKline knowingly manipulated the Paxil paediatric data - not only that, they also were involved in a marketing campaign to prove the safety and efficacy of Paxil in children - when they knew it wasn't safe for children and adolescents because there was a higher than normal risk of suicide in this particular age group.There has been a lot of visitors from Canada to this blog over the last 24 hours or so. It's not as powerful as CHCH-TV, channel 11, a television station in Hamilton, Ontario, Canada, whom Michael Blain spoke to during a recess. It will however create interest over the coming weeks and it will report and rebut anything that glorifies Paxil.This family need justice. They need someone to speak for the dead to protect the living. It is abundantly clear after only one day that they are not or will not be getting this from the Office of the Chief Coroner of Ontario.Please feel free to post or copy this article to your blogs and/or websites. Feel free to email friends, colleagues and family.Let us be the media for Sara Carlin and her family.Members of the jury and other interested parties may be interested to educate themselves on the Paxil 329 studies.The blurb of which can be read on the Healthy Skepticism website:All documents can be downloaded here This, will go a long way into getting Sara's voice heard.On May 6, 2007, Sara Carlin, a beautiful 18-year-old girl with everything to live for, grabbed a piece of electrical wiring, fashioned a crude noose and hanged herself in the basement of her parents house while under the influence of the antidepressant drug Paxil (Seroxat in the UK). Paxil/Seroxat is an antidepressant documented by international drug regulatory agencies as causing worsening depression and suicide particularly in children and young adults.Please help inform others of the risks of these drugs. Forward this video to everyone you know.RIP Sara Alison CarlinNessun DormaRELATED POSTS:ORDER THE PAPERBACK'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob FiddamanSIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING