Original Seroxat (Paxil) Study 329 Authors’ Belligerent And Glib Response To Damning Seroxat Child Suicide Study In The BMJ


http://www.bmj.com/content/351/bmj.h4320/rr-27

Paroxetine treatment in youth does not appear to significantly differ from other SSRIs in the risk of suicidal ideation or attempts and whether SSRIs increase or decrease completed suicide remains an open question

In the abstract we stated “Conclusions: Paroxetine is generally well tolerated and effective for major depression in adolescents.” In this sample and with the state of knowledge at the time, it was justified and appropriate.

Sincerely,

Martin B. Keller, M.D.
Boris Birmaher, M.D.
Gabrielle A. Carlson, MD
Gregory N. Clarke, Ph.D.
Graham J. Emslie, M.D.
Harold Koplewicz, M.D.
Stan Kutcher, M.D.
Neal Ryan, M.D.
William H. Sack, M.D.
Michael Strober, Ph.D.

Regular readers of this blog would be very much aware of the recent RIAT re-analysis of GSK’s Seroxat (Paxil) study 329 published in the BMJ last year. This study was damning not just for GSK and for Seroxat, but it was also damning because it showed up the original authors as little more than charlatans. The original ‘authors’ were not so much ‘authors’ in the traditional sense of the word, because they basically just sold their names to the study- most of it was written by a PR pharma ghost writer  (Sally Laden)- hired by GSK.

However, because the ‘authors’ were big names in medicine and psychiatry at the time, GSK’s marketing department used them so that they could push Seroxat (Paxil) to under 18’s. Seroxat should never ever have been prescribed to kids (and in my opinion Seroxat is just as dangerous in the adult population). Many kids died from Seroxat induced suicide, some self harmed from it, some committed acts of violence against themselves and others,  and many were severely damaged (and this happened to adults too).

So you would think, considering the immense harm that this study has done, and considering the agony that Seroxat has caused many tens of thousands of people globally (adults and children)- that the original authors would be ashamed that their names were used in this manner wouldn’t you?  You’d think that they would be utterly appalled to learn that kids died from Seroxat, and you’d think that they would attempt to retract this study from the academic record, and you’d think that- they would be deeply sorry that they were so easily led by a greedy, sociopathic drug company, wouldn’t you? You’d think they’d care..

But, no..

The authors aren’t really concerned about any of this at all…

It seems, judging by their glib, belligerent and arrogant response- in the BMJ- that the study authors really couldn’t give a damn at all..

Why are we surprised?

They did, after all, lend their names to the original fraudulent study.. so why wouldn’t they lend their names to a rebuttal?

But now, in defending the indefensible it seems the only traits I can see remaining in the ‘characters’ of these ‘key opinion leaders’, are ones that resemble stone cold sociopaths.

I find it extremely disturbing how these academics seem to be more concerned with smearing the RIAT authors reputations, playing word games, and muddying the waters with other nonsense, than the stark fact that- a corrupted study they lent their names to- ended up being used to drug kids (literally) to death…

We’re talking about a drug which makes kids kill themselves…isn’t that f*cked up?

I was 21 when I was prescribed Seroxat, and it was a horrible experience..

It was horrendous…  I can’t imagine what it would be like for a child..

You can’t defend the indefensible…

Only psychopaths, serial killers and sociopaths would attempt to do that…Study 329 was a disgusting example of ‘doctors’ and psychiatrists selling their reputations to amoral drug companies, there is no defending it..

It was abhorrent..


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Participant In Original GSK Seroxat (Paxil) Trial Speaks Out


From David Healy’s Blog: 

http://davidhealy.org/lives-touched-by-gsk/

Lives Touched by GSK

November 25, 2013 3 Comments

Anonymous

Notes of a Paxil Guinea Pig

What does GSK owe to the youngsters in its infamous Study 329 who became suicidal while taking the company’s paroxetine (Paxil/Seroxat)?

As someone who was briefly a GSK Guinea Pig, I’d say the most important thing they’re owed is the truth. It’s a highly delinquent debt – but it’s not too late for GSK to pay up.

I took part in a study of Paxil back in 1994. Like many U.S. subjects, I signed up mainly for the free medical care: I was tired of battling my employer’s HMO which doled out mental health treatment with an eyedropper. However, having already taken Prozac with little or no effect, I was also as curious as anyone to find out if these drugs “worked” or not, according to Big Science. I was willing to be a guinea pig if it would lead to some answers.

The protocol was that everyone was put on Paxil for a number of weeks, after which half of us would be switched cold-turkey to placebos, the other half would continue on Paxil.

Supposedly, this would determine whether people with “recurrent depression” should stay on long-term Paxil maintenance therapy. Looking back, however, what the study really did was to produce drug-withdrawal distress, then interpret that as the original depression coming back.

And most likely, by 1994, GSK knew that.

Treatment Related Injury?

After the switch to either placebo or Paxil I fell asleep at the wheel of my car and had an auto accident with minor injuries. I didn’t want to drop out – I was pretty sure the cause of my accident wasn’t Paxil, but working a sixteen-hour shift. But I was told the study protocol demanded my removal. Not knowing the research design, I never found out whether they were being conscientious, or just the opposite – dropping my results to cover up problems.

The Paxil hadn’t helped me much. But after the switch, I quickly felt the ground under my feet get rockier, at least for awhile.

Well, I thought, it didn’t feel like the Paxil was doing me any good – but here I was feeling worse without it. It didn’t occur to me that this could be down to Paxil withdrawal, because I had never heard of it.

Once the blind was broken, the researchers confirmed I had indeed been switched to placebo.

I never found out if my study was published. When I finally saw a psychiatrist, his reaction was that this had been a “pretty stupid study,” because “everyone already knew” that people like me who’d had several depressive spells should be on medication for life. That makes me think there were already multiple published studies of this type – and possibly dozens more that the drug companies never bothered to publish.

GSK & Responsibility

I’m angry with GSK, not only for putting me through Paxil withdrawal, which, thank god, was not severe in my case, but also for what they later did to me and other patients by hiding the results. They and the other drug manufacturers led millions of us to believe we needed these drugs for life, “just like diabetics need insulin.”

At a minimum this deprived millions of people of a normal sex life, and may have numbed their ability to respond to life in other ways. Untold numbers of children have been exposed in utero. And I and millions of others became part of a twenty-year uncontrolled experiment on the long-term use of these drugs to control a “deficiency” that we may never have had.

Study 329

For the kids in Study 329 who became suicidal on Paxil, GSK’s deception may have done much worse. To this day, I’d bet some of them don’t know the role of the drug in their suicide attempt. Being “the kid who tried to hang himself at fourteen” affected how they saw themselves, to say nothing of how their families, schools and juvenile courts may have seen them. It’s long overdue – but not too late – to tell them that “what you did was not necessarily your own doing.”

Knowing the facts about the limited effectiveness of these drugs could also open doors for those who have not responded to them. For two decades we’ve been told we were a small minority whose condition, being Treatment Resistant, must be very grave indeed. That verdict led many to accept punishing multidrug treatments, ECT, or simply becoming resigned to a life of disability.

Like the kids in Study 329, we deserve the opportunity to rewrite the life story handed to us by well-meaning professionals acting under the influence of GSK.

GSK owes…

It’s not too late to learn something useful from the changes GSK put us all through. It might help us learn more about SSRI withdrawal and SSRI-induced agitation, including who suffers what effects and why. I have no idea what consent forms I signed 20 years ago, but I sure as hell never intended to give GSK the right to hide the results of the experiment they ran on me.

GSK owes me the truth. It owes at least as much to many others, like the kids in Study 329, who suffered far more than I did. To say nothing of the patients who never took part in research, but whose lives were altered by it nonetheless. It would have been infinitely better if they had owned up twenty years ago. But that’s no reason to write off the debt now.

– See more at: http://davidhealy.org/lives-touched-by-gsk/#comments