More on Paxil and suicide – “Glaxo was aware of this risk, and hid it”

This from the Wall Street Journal By ALICIA MUNDY and JEANNE WHALEN (with thanks to Truthman30):

Unsealed Report Claims Suicide Risk Was Miscalculated

WASHINGTON — GlaxoSmithKline PLC faces new questions about whether it deliberately misrepresented data on suicide risk for its antidepressant Paxil when it applied for the drug’s approval to the U.S. Food and Drug Administration at an advisory committee meeting in 1991, a charge the company has denied.
A study by a Harvard psychiatry instructor, underwritten by plaintiffs’ lawyers and previously kept under seal by a court order, says that Glaxo “improperly” counted patients taking placebos during clinical studies. From 1989 through 1991, Glaxo then submitted information to the FDA that indicated no major difference in risk of suicidal behavior, or suicidality, as doctors call it, between patients who took Paxil and those who took a placebo.

However, Glaxo’s counting minimized the differences between suicidality rates in the Paxil and placebo groups, according to the report. For instance, the company counted placebo patients who had attempted or committed suicide before the study formally started, which enhanced the results for Paxil.

The real risk for suicidality from Paxil, says the report’s author, Joseph Glenmullen, was eight times its risk for patients on placebo. “Glaxo was aware of this risk, and hid it,” Dr. Glenmullen’s report states. The drug was approved for sale in the U.S. in 1992. Dr. Glenmullen said, in an interview Thursday, that if Glaxo had given the agency the “correct” data in 1991, the FDA would likely have added warnings about the risk for suicidality when it approved Paxil

In 2004, the FDA called for added warnings on popular antidepressants known as selective serotonin-reuptake inhibitors, or SSRIs, about potential links to suicidal behavior. In 2006, Glaxo sent a letter to doctors stating that its studies showed that the risk of suicidality in depressed adults was 6.7 times as high in patients taking Paxil as in those taking a placebo.

Thursday, Sen. Chuck Grassley, an Iowa Republican, released Dr. Glenmullen’s study and a letter to the FDA, asking it to investigate the original approval process for Paxil and Glaxo’s application in light of Dr. Glenmullen’s report.

A Glaxo spokeswoman emailed a company statement that was originally issued Feb. 6, when an earlier version of Dr. Glenmullen’s report was first unsealed by a court. That version was missing nine pages that included information on Glaxo’s counting methods.

“GlaxoSmithKline has provided the U.S. Food and Drug Administration over the years with numerous reports from its clinical studies,” the statement says. “As soon as GlaxoSmithKline became aware of a potential increased risk in certain populations, it proactively brought it to the attention of FDA and other regulatory bodies.”

The statement notes that Dr. Glenmullen was hired by plaintiffs’ lawyers, and calls his report “unscientific and misleading.”

Sen. Grassley also raised concerns about a British investigation that concluded this year that Glaxo should have alerted British regulators earlier than it did about a link between Paxil and suicidal behavior. He said evidence in the two reports raises questions about whether the company kept U.S., as well as British health officials, in the dark.

In March, British authorities concluded a four-year investigation on whether Glaxo failed to inform the U.K. drug regulator in a timely manner about a link between Paxil and suicidality in children and teens. They said they saw no basis for criminal prosecution of Glaxo because U.K. laws were unclear about whether companies were obligated to report certain drug data. But the regulator said it remained “concerned that GSK could and should have reported this information earlier than they did.”

Glaxo at the time said: “We firmly believe we acted properly and responsibly.”

Paxil was made by SmithKline Beecham, which merged with Glaxo Wellcome in 2000. SmithKline’s former top executive, Jean-Pierre Garnier, who was Glaxo’s CEO until last month, said in a 2006 deposition in a lawsuit that the original data given to the FDA shouldn’t have included some of the placebo patients. In another 2006 court document, Glaxo “admits that five of six ‘attempted suicide’ events” in the placebo group took place before the studies began.

During the 1991 meeting, members of the FDA’s advisory committee repeatedly said they wished there were more data to review on suicidality, but, the report said, “unbeknownst to the committee, the data already existed.”

Write to Alicia Mundy at alicia.mundy@wsj.com and Jeanne Whalen at jeanne.whalen@wsj.com

7 Responses to “More on Paxil and suicide – “Glaxo was aware of this risk, and hid it””

  1. truthman30 Says:

    This is what we have all been talking about for years..

    Seroxat causes suicidal thoughts , it makes depressed people more suicidal..

    It needs to be banned..

  2. thecountryshrink Says:

    I wouldn’t say necessarily that it needs to be banned. I probably doesn’t direct cause suicide, but may cause increased agitation. It may increase the risk, but not actually “cause” suicide.

    I write more about antidepressants on my blog.

    http://thecountryshrink.com

  3. truthman30 Says:

    Well, I would say that it absolutely needs to be banned…

    Yes, I agree it does cause increased agitation, I was prescribed it myself and I and many others who I have met and spoken too also experienced this and a host of other disturbing , debilitating and disgusting side effects…

    The problem with Seroxat is the side effects in themselves would drive anyone over the edge and towards suicide…

    Depersonalization , Derealization and Akathisia are torturous to endure…

    They affect the mind in ways which the human mind was never meant to experience…They make you feel a turmoil and anguish which is often beyond the scope of comprehension…

    Imagine sitting on the edge of your bed, shaking, twitching and aching, spasming, sweating and scared, your stomach churning , a tightness in your chest and a vice like headache , afraid to even move for a crippling intense panic and anxiety attack keeps you frozen and unable.. Your mind spinning with confusion, anger, fear and terror…Imagine that feeling for weeks and months on end….

    That’s what Seroxat does to people..

    And the people it is prescribed to are very vulnerable to begin with..
    It is no suprise at all that it drives people to take their own lives…
    It is only those who were prescribed this poison who truly know the horror it can cause…
    It is all very fine for psychiatrists and the media to pass comment on Seroxat, but ultimately the knowledge of its dangers lies with those who have experienced it…

    There are almost 10,000 documented experiences of these suicide inducing side effects on the paxil petition :

    http://www.petitiononline.com/mod_perl/signed.cgi?oky71

    There are numerous withdrawal forums on the internet about this drug with literally hundreds of thousands more stories of peoples lives been ruined by the ingeston of this drug :

    http://www.paxilprogress.org/forums/

    http://www.seroxatmad.co.uk/forum/index.php

    http://www.quitpaxil.org/

    The first of Four BBC documentaries exposing Seroxat had an unprecedented 64 000 phonecall responses from people concerned about this drug…

    http://news.bbc.co.uk/2/hi/programmes/panorama/2982797.stm

    Also taking into account its effects on newborns (defects etc), the fact that it is banned for under 18’s, the fact that GSK now warn young adults (18-29) are at a high risk of suicide also, the fact that GSK suppressed side effects for years, the fact that coroners and mental healthgroups (including Mind) have long been calling for restriction of its use.. Does all this warrant a ban? .. Absolutely..

    Taking all this into account, personally I think Seroxat should be gradually withdrawn from the market, and no new prescriptions should be written for it, current users should be tapered off the drug and it should be phased out…

    It may be argued that seroxat doesn’t “directly” cause suicide as you say, but it does cause these side effects which can lead to suicide, so in my estimation that is the same thing…

    Semantics are all very well, but the Seroxat scandal has gone on a little too long for that at this stage…

    It is like saying “guns don’t kill people, people do” or
    It’s like saying “hitting your head off a brick wall doesn’t cause skull damage”, the wall itself doesn’t cause the skull damage no, but if you hit your head off it enough times it will..

    So does hitting your head off a brick wall cause skull damage?

    Yes..

    And does taking Seroxat make you more suicidal?..

    Yes it does…

  4. truthman30 Says:

    “I wouldn’t say necessarily that it needs to be banned. I probably doesn’t direct cause suicide, but may cause increased agitation. It may increase the risk, but not actually “cause” suicide. ”

    Well, you obviously haven’t read enough about it then…

    There are numerous studies which indicate Paxil-Seroxat increases suicidal thoughts… This is one of them from 2005

    http://www.timesonline.co.uk/tol/news/uk/article556899.ece

    And anyway, if as you say, it possibly increases the “risk” of suicide by increasing “agitation”, then surely prescrbing an anti-depressant which in any way increases the risk of suicide is a ridiculously dangerous thing to do? …

    Are anti-depressants not by their conceived idea supposed to prevent suicide? not “cause it” ?

    And if Paxil has the possibility of creating factors such as agitation and turmoil which could lead to suicide , surely it would be logical to conclude that it is not a safe option for treating depressed people? …

    http://thecountryshrink.com/2008/06/17/antidepressant-medication-and-suicide/

    I notice on your blog you say :

    ” I’m not saying Paxil directly causes suicide, because that is an individual decision. But it may increase other factors, such as agitation, which may increase the risk. I’m saying that psychologists and therapists who are comfortable in treating depression need not fear increased risk of liability frankly there is no evidence at all that you would be increasing their suicide risk if they did not take medication for depression. Quite the opposite in my opinion. ”

    Interesting…

    Personally I believe the only reason GSK have gotten away with making an anti-depressant which increases suicide is because it will always be difficult to distinguish a drug inducing suicide or the “illness” inducing suicide…
    GSk are well aware of this, and it is something which they have exploited withe their denial of Seroxat problems over the years…

    So in essense that makes it the perfect crime…
    And for almost two decades now, it still goes on…

    And anyway, they have made their Billions, the deaths from Seroxat are just statistical in their corporate vision…

    After all, we can’t ask the victims of Seroxat induced suicides any questions about it from beyond the grave can we?..

    But what we can do is weigh up the wealth of stories, comments and experiences of those who have taken the drug, and what this knowledge overwhelmingly points to is that for many many people Seroxat causes massive problems of suicidality, aggression, addiction and withdrawal…

    Most of this has been conveniently dismissed as “anecdotal” by the regulators, but i would rather think of these stories as “eye witness accounts” , experienced by those who went through it…

  5. thecountryshrink Says:

    Thanks truthman30. I was not aware of all the sites you point out. I’ve never been a big fan of any antidepressants because of the biased way that research is conducted and meager evidence that they are even helpful compared to placebo. Do you think that the risks are really less with SSRIs other than seroxat?

  6. truthman30 Says:

    Do you think that the risks are really less with SSRIs other than seroxat?

    No, I think most of them have similar risks and similar (non) efficacy…

    Seroxat and Effexor seem to be the worst where side effects and withdrawals are concerned though…

  7. Khan Says:

    I know two people who were given seroxat – if the owners of Glaxo came anywhere near me – I would unhesitatingly attack them . Our doctors are certainly criminally lacking in their reactions to the ‘pharmaceutical’ industry in that they still use there wares – nature is truly more efficacious in healing – far more .

    Lets hope and fight for peace and harmonic bliss on this planet .


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