MPs call upon the Government to provide withdrawal clinics for people addicted to Seroxat…

… and other SSRIs

Oh, and also for the review into the MHRA that was recommended 3 years ago!

Early Day Motion 1056 by Jim Dobbin MP – SSRI ANTI-DEPRESSANTS

26.02.2008
That this House welcomes the Department of Health’s announcement to increase the provision of talking therapy for depression; notes Professor Irving Kirsch’s study of the manufacturer’s trials of the SSRI anti-depressants Prozac, Seroxat and Efexor and his conclusion that these drugs are not effective; notes that there is zero cost-effectiveness to drugs that do not work; further notes that large numbers of people are involuntary addicted to these drugs and suffer bizarre and severe side effects which leave them unable to work; calls upon the National Institute of Health and Clinical Excellence to review the approval of these drugs; calls upon the Government to provide withdrawal clinics for people addicted to prescribed drugs; further calls upon the Government to provide appropriate rehabilitation to bring these people back into the workforce; urges the Government to organise controlled withdrawal of these drugs from the market; and further urges the Government to investigate how the manufacturers and distributors obtained product licences and to implement the recommendations of the Fourth Report of the Health Committee, Session 2004-05, on the Influence of the Pharmaceutical Industry, HC42-1, including an independent review of the UK drug licensing authority the Medicines and Healthcare Products Regulatory Agency.

Signed by the following MPs:

Dobbin, Jim
Spink, Bob
Younger-Ross, Richard
Clapham, Michael
Smith, Geraldine
Cryer, Ann
Heppell, John
Hoyle, Lindsay
Kilfoyle, Peter
Laxton, Bob
Lloyd, Tony
Crausby, David
Gibson, Ian
Mulholland, Greg
Prentice, Gordon
Holmes, Paul
Jenkins, Brian
Jones, Lynne
Campbell, Ronnie
Caton, Martin
Corbyn, Jeremy
Dismore, Andrew
Francis, Hywel
Hancock, Mike
Taylor, David
Turner, Desmond
Vis, Rudi
Hemming, John
Hosie, Stewart
Hunter, Mark

And another EDM:

EDM 1041 by Paul Flynn
ANTI-DEPRESSANT DRUG TRIALS
26.02.2008

That this House welcomes the revelation under Freedom of Information of un-published trial reports on anti-depressants that prove they are no more effective than placebos for the great majority of patients; deplores the practice of pharmaceutical companies of suppressing publication of trials with negative results that has encouraged the over-prescription of drugs that have serious adverse side-effects; and calls for a re-appraisal of the efficacy of drug treatment for mild depression compared with the drug-free therapies of exercise and cognitive behaviour therapy.

GlaxoSmithKline – the game is up as Seroxat is proved to be no better than a sugar pill, but so much more dangerous

I’ve been an interested observer today – and what a holy shit-storm of a day.

It’s everywhere – the drugs don’t work – they just make you worse.

Bob Fiddaman has the very best round up of all the stories here… and doesn’t it just go on and on.

And all the while Glaxo squirms and spins:

GlaxoSmithKline, makers of Seroxat, said the authors of the study had “failed to acknowledge” the very positive benefits of SSRIs and their conclusions were “at odds with the very positive benefits seen in actual clinical practice.” A spokesperson added: “This one study should not be used to cause unnecessary alarm for patients.

BUT THE SPOKESPERSON HAS MISSED THE POINT – THIS IS NOT JUST ONE STUDY… IT’S LOTS OF THEM ANALYSED TOGETHER YOU IDIOT.

AND WHO IS TO SAY ANY POSITIVE EFFECT SEEN IN CLINICAL PRACTICE IS NOT MERELY A PLACEBO EFFECT?

Jeremy Laurance in the Independent sums it all up very well – The vested interests that conspire to bury bad news…“Publication bias” is not a phrase widely familiar to people outside the world of academic research. Yet it can explain how a drug launched as a safe and effective treatment can later turn out to be useless, or even deadly.Pharmaceutical companies invest millions of pounds in drug research and have a powerful commercial interest in publishing positive findings for the medicines they have spent years developing.

But they are equally keen to keep quiet about those trials which show no effect.

Medical journals comply in this process of self-censorship because, like the lay media, they are competing for readers and positive results – the more dramatic the better – attract more attention. The result is that over months and years, an impression is created that a drug is more effective, and has fewer side-effects, than is really the case.This is known as “publication bias”, the selection of only positive studies for publication. If all the studies conducted, positive and negative, were reviewed the overall impression might be very different.

Publication bias has been blamed for the debacle over the powerful painkiller Vioxx, dramatically withdrawn from the market in 2004, after it was suspected of causing heart attacks. The fatal side-effect had not been picked up despite years of research in thousands of patients. Now it is being blamed for the revelation that two decades after their launch, the new-generation anti-depressants, including Prozac and Seroxat, may be no better than placebos.

Data obtained from the Food and Drug Administration in the United States under freedom of information legislation showed that when all the trials, published and unpublished, submitted at the time the drugs were licensed were analysed, it showed no clinically significant effect. The finding makes the review of the present Nice guidelines on the treatment of depression “all the more urgent”, according to Tim Kendall, the head of group responsible for drawing them up.

The present guidelines, issued in 2004, recommend psychological treatments be offered as an alternative to drugs, especially in mild depression, a change from the original guidelines which recommended drugs as the first line of treatment. Revised guidelines are due at the end of the year.

Dr Kendall, a consultant psychiatrist in Sheffield, said: “The doubt the study raises is how much confidence we can have in our current data set, which is much bigger [than in the study] but may not be complete. The drug industry says they are being much more open but I am not convinced we are seeing the data we should see, and we are certainly not seeing what the licensing authorities are seeing.”

Grassley receives GSK’s Paxil documents, but his concerns remain

A spokeswoman for Sen. Charles Grassley says documents submitted by GlaxoSmithKline on its drug Paxil have, at first glance, not alleviated the lawmaker’s suspicions that GSK knew about increased suicide risks associated with the antidepressant years before it sent a 2006 warning letter to physicians.

“Our concerns have not changed,” says spokeswoman Jill Kozeny.

The lawmaker received a tall stack of papers from GSK the day after his deadline for the company to submit documents on Paxil. Kozeny says Grassley’s staff is going through the documents this week and declined to comment on the next steps Grassley might be.

Read more about Grassley and GlaxoSmithKline’s missing documents here and here.

Pensioner on Seroxat Denies Assaulting his Doctor

Or maybe this should be a story about a Doctor who assaulted his patient with the antidepressant Seroxat?

I wonder how much Dr. Ian Palin knew about the drug when he prescribed it – did he bother to find anything out about Seroxat beyond what Glaxo’s drug reps told him?

And what previous convictions for assault does 69 year-old Mr Bradley have I wonder?

Could Seroxat be connected in any way to Mr Bradley’s behaviour…. hmm….

Read on – this from the Derry Journal:

A sixty-nine years old retired civil servant has gone on trial in Derry
charged with punching his doctor in the face in the city’s Clarendon Medical
Centre.

John Francis Bradley from Academy Road, denies a charge of common assault
against Dr. Ian Palin. He’s alleged to have committed the offence in the
doctor’s surgery on May 15, 2006, when they had a disagreement about the
defendant’s continued use of the anti-depressant drug Seroxat.

In his evidence on the first day of the trial at Derry Crown Court before a
jury of six men and six women, Dr. Palin said he had worked as a G.P. in the
medical centre for over thirty years. When the defendant arrived for his
appointment on the afternooon of May 15, 2006, Dr. Palin said he noticed he
was anxious and upset and constantly talked.

The witness said the defendant was being treated for a number of physical
and mental health concerns and during the consultation the defendant said he
had watched a television documentary the previous night which linked Seroxat
to a number of suicides in England, something that made him unhappy to
continue taking the drug.

Dr. Palin said the defendant had been on Seroxat for two years because of
his history of depression. He described the defendant as anxious, nervy and
constantly repeating things.

“He became agitated and began to swear and was verbally abusive to me.
He continued with his complaints and I realised he wasn’t listening to me. I
began to rise to indicate that the consultation was over and I moved towards
the door so that I could open it to let him out”. he said.

“After I told him I felt the consultation could not continue, I began to
rise. Mr. Bradley leapt to his feet. He said ‘you bastard’ and he came at me
kicking and punching me a number of times. One punch connected with the left
side of my head. Most of them were glancing blows and I was able to fend
them off and I tried to hold his arms to stop him punching me and I fended
him off”, he added.

Dr. Palin said the defendant then lay down on the floor in the foetal
position before he eventually left the surgery. He said the defendant said
he would say that he had struck him and that he was going to report the
doctor to the B.M.A. The witness said that following the alleged assault,
the defendant had been removed from the medical centre’s list of patients.

Dr. Paul Molloy who works with Dr. Palin in the medical centre, said he was
holding a surgery in the centre at the time of the alleged incident after
which Dr. Palin came into his surgery.

“He complained that his eye, his left eye, was a wee bit sore. I examined
the left eye. I found it was tender, no bruising with no break in the skin”,
he said.

Dr. Molloy said he took Dr. Palin’s pulse and blood pressure readings but
results did not cause him any alarm.

The trial continues.

Sounds like a real bad assault, Dr Palin – perhaps you should ask yourself what might have caused it, eh?

How a dumbed-down form of psychiatry has been a boon for the drug companies

This from today’s Times – another review of Christopher Lane’s SHYNESS – How normal behaviour became a sickness
(Yale University Press).

In 2000, an enterprising reporter on the Boston Globe, aware that the patent for the billion-dollar-selling anti-depressant drug Prozac was soon to expire, checked to see if an application had been filed for a new version and found that it had. Such applications have to state what the improved benefits of the new drug will be. Among them was this claim: “It will not produce several existing side-effects, including suicidal thoughts and self-mutilation . . . one of its [Prozac’s] more significant side-effects”. This story is related in Let Them Eat Prozac: The unhealthy relationship between the pharmaceutical industry and depression (2004) by the British psychiatrist David Healy. It also appears in Christopher Lane’s Shyness, which draws heavily on Healy’s book. What makes it worth retelling is that Eli Lilly, the manufacturers of Prozac, had consistently denied that there was any evidence that the drug raised suicide risks, claiming that it was “safe and well tolerated”.

Launched in 1989, at a time when there was growing concern over the addictive properties of tranquillizers such as Valium and Librium, which could also be lethal in an overdose, Prozac was promoted as virtually side-effect free and proved hugely popular; by 1999, it accounted for 25 per cent of Eli Lilly’s $10 billion revenue. Prozac was the first of a new type of drug known as SSRI’s (selective serotonin reuptake inhibitors) which targeted the neurotransmitter serotonin in the brain. The widely accepted theory, supported by very little evidence, was that low levels of serotonin caused depression, so that the drugs were simply correcting a biological deficiency. But, by the end of the 1990s, almost drowned out by reports of their beneficial effects – depression lifted, personalities transformed – voices started warning of a darker side.

The most persistent of these was that of David Healy, who had acted as an expert witness in two American court cases involving claims that an SSRI had caused outbreaks of violence and suicide. As such, he had had access to unpublished studies held by the manufacturers, showing that the drugs doubled or tripled the risk of suicide. He also claimed that their effectiveness had been greatly exaggerated. At the time of the Boston Globe story, Healy, who heads an NHS psychiatric clinic in North Wales, was regarded as an unreliable maverick for making such claims. Today, however, they are widely accepted. In 2000, a large study, published in the Archives of General Psychiatry and based on 5,200 pages of documents submitted to the FDA over ten years for SSRI licence applications, concluded that not only were the drugs no better than the older anti-depressants, but they were less than 10 per cent more effective than placebos, which produced an average of a 30.9 per cent improvement in depression.

Three years later the UK’s drug regulatory body, the MHRA, which had assured Healy many times that there was no cause for alarm, warned that these drugs doubled the risk of suicide in children, based on research data dating back to 1996. The evidence involved three trials of an SSRI called Seroxat, only one of which had been published. An analysis of all three found that 6.5 per cent of children on the drug showed “emotional liability” (which includes suicidal thinking) compared with 1.4 per cent of those on the placebo. SSRIs now come with a suicide warning. The result of these and similar findings has been to create a crisis of confidence among GPs and mental-health professionals over the best way to treat depression, anxiety and simple unhappiness. Between 1991 and 2001, antidepressant prescriptions in the UK rose from 9 million to 24 million a year; but now questions are being asked about whether such a heavy reliance on the pharmacological approach is wise.

The achievement of Christopher Lane’s book Shyness is to chart for the first time the events preceding the rise and fall of the SSRIs. Just as Healy used unpublished drug-company data to highlight the suicide problem, so Lane has marshalled a cache of unpublished data to explain the academic framework that allowed the rise to happen.

When diagnosing mental health problems, American psychiatrists rely on the Diagnostic and Statistical Manual of Mental Disorders, which classifies disorders and lists their symptoms. First published in 1952, it was revised in 1968 and again in 1980. It is that third revision, known as DSM III, that Lane focuses on. Drawing on previously unpublished documents held in the archives of the American Psychiatric Association, he reveals the inner workings of the committee that sat for seven years and drastically revised the manual, creating 112 new disorders, including Social Phobia – later changed to “Social Anxiety Disorder” – the “shyness” of Lane’s title.

Officially, that revision transformed the manual and, by extension, psychiatry into a “pristine scientific entity”. This was done partly by removing virtually all traces of the psychoanalytic model of mental functioning from the definitions and symptoms. Out went all the unprovable speculations about psychosexual dramas of the ego and the id, and in their place an “atheoretical” system was created that listed only symptoms and was agnostic about cause; a system that could be quantified and standardized much more easily.

However what actually happened, according to the raw material of the archives, was quite different, and Lane tells the complex story with impressive clarity. Far from being the distillation of new research and scientific studies, the new disorders emerged from rounds of bureaucratic infighting and the sort of wheeler-dealing that produces the manifestos of political parties. On one occasion, during a forty-minute meeting, Professor Robert Spitzer, the chairman of the revising committee, together with two other psychiatrists, apparently decided that the old diagnosis of “hysterical psychosis” should be split in two. One was to be characterized by “short episodes of delusion”, the other by “showing up in an emergency room without authentic cause”. The first they called “brief reactive psychosis”, the second “factitious disorder”. Spitzer typed out the list of symptoms for each, then and there.

So how did Spitzer and his committee decide on a new disorder? “We’d ask how logical it was”, he said. “Whether it would fit in. The main thing was that it should make sense. It was the best thinking of people who seemed to have expertise in that area.” In fact the process could be even vaguer. Some disorders were included on the basis of just one patient, treated by the same clinician who was putting the disorder forward. In other cases the symptoms wouldn’t have seemed out of place in a saloon-bar discussion. Signs of “chronic complaint disorder” include grumbling too much about the weather or saying “Oy vay” too many times.

The closest that shyness had come to being pathological prior to DSM III was in a condition called social phobia that was regarded as very rare. In an interview with Lane, Spitzer explained why it was necessary to distinguish severe anxiety over social situations from other phobias: “Well, with specific phobias there are things that scare people like snakes or heights. And then some people avoid people so let’s call that social phobia”. Symptoms of this new affliction could be experienced by almost everyone; they include “Fear of sounding foolish” and “Being stumped when asked a question in a social setting”. Despite the bar for diagnosis being set so low, it was described by the National Institute for Mental Health as “one of the worst neglected disorders of our time”. Later on psychiatric experts would regularly claim that the new disorder affected 18 per cent of the American population. But, as Lane shows, the only evidence for this was a single telephone survey of 500 Canadians; using only slightly more stringent criteria could reduce the prevalence to 1 per cent. As one of the consultants to the revising committee, Theodore Millon, conceded in an interview in 2005: “There was very little systematic research, and much of the research that existed was really a hodgepodge – scattered, inconsistent and ambiguous”.

On such a flimsy underpinning was the new disorder launched – one of seven new anxiety disorders that were often hard to distinguish, including Schizoid Personality Disorder and Avoidant Personality Disorder. But as soon as they appeared in DSM III, such shortcomings were all forgotten, and the new disorders rapidly became targets for aggressively promoted drug treatments.

Early in its deliberations the committee had stated that the manual should only diagnose conditions that caused one of the 4Ds – acute distress, dysfunction, deviance, or danger. This didn’t last long, however, not least because the checklists of symptoms cast their net so wide. Some clinicians thought it fine to gauge impairment by whether a person with a supposedly avoidant personality preferred travelling to work by car or on public transportation. The pharmaceutical companies reinforced this confusion by stressing that Social Phobia was a serious medical condition and a lifestyle issue. The drugs, the American advertisements claimed, could help you regain “emotional balance”; they featured models and catchlines like “Your life is waiting”. But not only did the drug treatments replicate the confusion over severity found in DSM III, they also mirrored the lack of clear distinction between the newly created disorders; it seemed the revision had created distinctions without a difference. Whether your problem was generalized anxiety, Social Phobia, major depression, Obsessive Compulsive Disorder or Premenstrual Dysphoric Disorder, the treatment was always the same – antidepressant SSRIs, dispensed in far greater numbers than any psychotropic drugs had been before. The “pristine scientific entity” had contributed to a giant uncontrolled experiment in mass-medicating.

For Lane, the real tragedy of DSM III was that it produced a dumbed-down form of psychiatry that takes little account of the complexities of the unconscious, and its influence on our behaviour, as identified by Freud. The checklists of behavioural symptoms used to diagnose disorders in DSM III take no account of a patient’s personal history. And concentrating on externals in psychiatric diagnosis takes little account of how symptoms are experienced by the patient. Maybe that wouldn’t matter if the medical drug model had been successful. This postulates that certain behaviours indicate a neurochemical deficiency – analogous to, say, low insulin – which can be returned to a healthy level with a drug. Quite apart from its shaky biochemical basis – both Healy and Lane demolish it – the results of applying it have not been impressive.

Resent research has raised serious doubts about the safety and efficacy of drug treatments for young people with either depression or ADHD; hundreds of thousands of demented elderly patients in the UK are currently treated with antipsychotics that have been shown to be both damaging and ineffective in this patient group. The problem is that the pharmaceutical dominance of psychiatry has pushed the profession into a corner: drug treatments are virtually all that is available. NICE guidelines recommend that depression be treated with some form of psychotherapy but it is estimated that 10,000 more therapists would be needed to implement the policy. Lane has done a valuable job in tracing the roots of the current crisis and he certainly isn’t calling for a reinstatement of Freudianism; what is needed now is another map to indicate a way out.

The missing nine pages – GlaxoSmithKline misses Sentator Grassley’s deadline and continues to hide evidence

Just how long does it take to write an email with a PDF attachment of nine missing pages?

Half an hour?

15 minutes?

No time at all if you have nothing to hide and want to be open and honest… shame that this obviously doesn’t apply to GlaxoSmithKline.

This from Charles Grassley’s letter to Glaxo on February 6 this year:

It is my understanding that 9 pages of Dr. Glenmullen’s report are not available
publicly. Accordingly, please respond to the following questions and request for
information. Please repeat each enumerated question and follow it with your response.

1. When did GSK first learn that Paxil was associated with an increased suicide
risk?

2. When did GSK first report to FDA that Paxil was associated with an increased
suicide risk?

3. When did GSK first notify patients and doctors that Paxil was associated with
an increased suicide risk? Please provide all pertinent documents and
communications.

4. Please provide the Committee with the complete, unredacted version of Dr.
Glenmullen’s report. Along with that report, please provide the appendix and
all documents that are referred to in the report, in the order that they are
referenced.

5. Please provide the Committee with the accompanying children and
adolescents report. Along with this report, please provide the appendix and all
documents that are noted in the report, in the order that they are referenced.

Thank you again for your continued assistance in this matter.

Because I understand that these documents are already available in electronic format, I would
appreciate receiving the documents and information requested by no later than February
14, 2008.

The deadline’s come and gone – what are you hiding from us Glaxo?

Read more here and here.

Stephen Kazmierczak – the Illinois gunman stopped taking Paxil (Seroxat)…?

… according to news channel ABC7 Chicago – full story here:

“Authorities have not figured out what motivated the man, described as a hardworking, award-winning former honor student by NIU faculty, to go on a shooting rampage that killed five students.

Kazmierczak, 27, was treated for mental illness nine years ago. He was considered volatile, according to a staff member who worked at the facility at the time, and violent if he stopped taking the antidepressant and anti-anxiety pills prescribed for him. Including Paxil, it was medication he was supposed to still be taking and apparently stopped a couple of weeks ago.”

So Paxil/Seroxat may have been involved in this tragedy, however we need to know the details – we need to know the truth.

Read more:

A brief history of school shootings

The Finland Massacre

SSRI stories

Antidepressants and violence

Nebraska shooting – antidepressant connection yet again?

Update: There is now confirmation that the anti-depressant NIU shooter Steven Kazmierczak went off of a few weeks ago was Prozac, but it’s not clear if he was on the original patented version made by Lilly or if he was on a generic. His ex-girlfriend told CNN that the drug made him feel like a “zombie.”

Stephen Kazmierczak – the Illinois gunman who ‘stopped his medication’

Every time there is a school shooting in America, my first thought on hearing the news is…“I wonder if antidepressants are involved”.

We don’t know yet in the latest case in Illinois if antidepressants where involved, but we do know “Officials have said that the man who killed five students and injured many more before turning the gun on himself at Northern Illinois University had become erratic in the past two weeks after stopping his medication”.

I wonder what more we will find out?

For more on this story, see here.

For more on school shootings see here and  here.

Time to join up the dots?

Senator Charles Grassley and the incomplete GlaxoSmithKline documents – where are the missing 9 pages?

“Couldn’t have put this account better myself so I will republish it in its entirety here”, so writes Bob Fiddaman over at Seroxat Sufferers.

I totally agree with him so here it is again – I can’t tell you how shocking it is :

It’s taken from Lawyers and Settlements.com

Washington, DC: Apparently, GlaxoSmithKline is still trying to hide damaging information about Paxil, because 9 pages of a report released from under a court order last month, are not available to the public. However, Senator Charles Grassley has instructed Glaxo to provide him with the full report by February 14, 2008.

In the report, which is dated roughly 6 months ago on June 29, 2007, Harvard Professor, Dr Joseph Glenmullen reveals that Glaxo had clinical trial data since 1989 which showed that Paxil increases the risk of suicide by more than 8-fold compared to patients who received a placebo.

The report was submitted in O’Neal v Glaxo, a lawsuit filed in a California federal court by the surviving family members of Benjamin Bratt who committed suicide at age 13 while on Paxil. The family is represented by the California law firm of Baum, Hedlund, Aristei & Goldman.

On January 30, 2008, the judge dismissed the case on the basis of the new preemption policy of the Bush Administration, but the family intends to ask the court to reconsider the ruling, according to Baum Hedlund.

In his report, Dr Glenmullen also makes a plea for public disclosure of all information that remains sealed under court orders on the basis of Glaxo’s claim that the documents contain trade secrets and states:

“Given the importance of GlaxoSmithKline’s internal documents, it is unfortunate that so many of the documents cited in this report and the attached Appendix are still confidential.”

“Given the stakes for public health and safety, GlaxoSmithKline should not be permitted to claim the documents are proprietary trade secrets.”

“All the documents should be made part of the public record so the full story of Paxil-induced suicidality can be told and the additional necessary steps can be taken to fully protect patients and the public.”

Dr Glenmullen also mentions a companion report related to children and adolescents and a “Specific Causation Report” in the case of Benjamin Bratt, and Senator Grassley has instructed Glaxo to provide him with a copy of that report as well.

In what can only be viewed as an eerily prophetic comment, in a letter back on September 16, 2004, to the Secretary of Health and Human Services, and the acting FDA Commissioner at the time, Senator Grassley warned: “I intend to keep the FDA’s feet to the fire to insure that the American public is knowledgeable about the risks of SSRI’s.”

SSRI’s refer to antidepressants known as selective serotonin reuptake inhibitors that include Paxil, Eli Lilly’s Prozac, Zoloft by Pfizer and Celexa and Lexapro marketed by Forest Labs, along with their generic counterparts. Lilly’s Cymbalta, Wyeth’s Effexor and Glaxo’s Wellbutrin are often referred to as SSRI’s but they are slightly different chemically. However, the new antidepressants all carry the same warnings about the suicide risks.

Senator Grassley’s letter followed the vote by an FDA advisory committee for a black box warning about the increased risk of suicide with kids to be added to the drugs’ labels. His angry tone, and not so subtle threat, was due to the fact that, during the advisory committee meeting, it became apparent that not only Glaxo, but all the SSRI makers, had concealed and misrepresented clinical trial data for years in the published medical literature which clearly indicated that there was an increased risk of suicidality with SSRI use.

In fact, as soon as Glaxo’s was asked about the hidden studies by regulators in the UK, Glaxo issued a “Dear Doctor” letter to physicians in England saying Paxil should not be prescribed to children because it “failed” to work any better than a placebo and frequently caused “hostility, agitation, emotional lability (including crying, mood fluctuations, self-harm, suicidal thoughts, and attempted suicides.)”

Glaxo did not issue any such warning to doctors in the US.

The paper that garnered the most wrath from pharmacology experts all over the world was published in the July 2001 issue of the Journal of the American Academy of Child and Adolescent Psychiatry on Paxil study 329, which was conducted from 1993 through to late 1995 or early 1996, according to a leading pharmacology expert, Dr David Healy. Twenty academics, considered to be the tops in their field, signed off on the study.

The main authors of paper on the study were later found to be in constant contact with Glaxo when the media began reporting that the data published was fraudulent, and include Dr Martin Keller, Dr Neil Ryan and Dr Karen Wagner.

In the paper, the authors write: “Of the 11 patients only headache (one patient) was considered to be related to the treatment,” and Paxil is “generally well tolerated and effective.”

However, when the actual study was analyzed in 2003, it showed suicidal acts by 5 out of 93 children on Paxil compared to no suicidal acts in the 89 children who received placebo.

On January 29, 2007, the BBC’s Panorama broadcast, “Secrets of the Drug Trials.” Attorney Karen Barth Menzies obtained many of the secret Paxil documents that were quoted during litigation, and she explained how Glaxo found ways “to blow up out of proportion the supposed benefits in Study 329 and downplayed the negative findings.”

Glaxo recruited the opinion leaders to put their names on the published 329 study, she said, because they were academics whom everybody looked up to, and the company knew that doctors would be far more likely to prescribe Paxil after listening to these doctors than they would be if approached by Glaxo salespersons.

One letter that was quoted, revealed that these so-called opinion leaders never even wrote a paper. The letter was from a ghost writer to Dr Keller, informing him that all the necessary materials were enclosed for him to submit the study to a journal for publication. The packet even included a cover letter, with instructions telling Dr Keller to: “please re-type on your letterhead. Revise if you wish.”

Dr Wagner, along with Dr Graham Emslie, was also responsible for publishing papers on studies that resulted in Prozac’s approval for children, and Dr Wagner and Dr Keller were also investigators on Zoloft studies and several of the unpublished Paxil studies.

In the October 4, 1999 Boston Globe, Alison Bass reported that in 1998, as a professor at Brown University, Dr Keller was forced to forfeit “hundreds of thousands of dollars” in state grant money and was paid more than $500,000 in consulting fees in 1998, most of it from companies whose drugs he touted in medical journals and at conferences.

In the report, Ms Bass pointed out that Keller was a valuable resource for the University, and had brought in about $14.4 million in research funding from drug companies and federal agencies since 1993.

According to the report, in 1998, the year Keller published 3 studies with colleagues in the Journal of the American Medical Association and the Journal of Clinical Psychiatry touting the efficacy of Zoloft, he received $218,000 in personal income and more than $3 million in research funding from Zoloft maker Pfizer.

Several ethicists contacted by the Globe said Keller’s unusually large consulting fees, a total of $556,000 in 1998 and $444,000 in 1997, constitute the most serious potential conflict they’ve heard of yet, Ms Bass noted.

Dr Wagner received an onslaught of criticism from experts all over the world when she misrepresented trial data in a paper on Zoloft, claiming it was safe and effective for use with children. On November 29, 2004, Barry Meier wrote, “Contracts Keep Drug Research Out of Reach,” in the New York Times, and reported that over the past decade, Dr Wagner from the University of Texas Medical Center in Galveston had led or worked on some 20 studies published in medical journals and had also “attracted a large number of industry-financed studies, including those aimed at testing whether antidepressants approved for use in adults were safe and effective in children and adolescents.”

In a financial filing with the university in December 1999, Mr Meier found the same month that a Zoloft trial began recruiting patients, Dr Wagner disclosed that she had received more than $10,000 from Pfizer but she did not provide details.

She also did not respond to written questions about the payments but a lawyer for the school, told Mr Meier that Dr Wagner had told him that Pfizer had paid her $20,500 during the course of the Zoloft trial. Mr Meier also noted that academic researchers routinely receive speaking and consulting fees from companies whose products they test and at Galveston the financial threshold for such a review is $10,000. But the school lawyer, told

Mr Meier that the center had been unable to locate records related to Pfizer’s payments to Dr Wagner.

Glaxo’s study 329 was successfully used to promote Paxil for children, and sales to kids skyrocketed to $55 million in 2002 alone. It also served as the smoking gun in a lawsuit filed against Glaxo by New York Attorney Elliot Spitzer, charging Glaxo with fraud for promoting the off-label use of Paxil to children while concealing and misrepresenting the data from 5 studies that showed the increased suicide risks and the fact that Paxil did not work with children. Glaxo settled out of court to shut that lawsuit down within 2 months.

In 2003, after reviewing the same fraudulent studies, the UK banned the use of Paxil with children, and the FDA scheduled an advisory committee meeting in February 2004 to review the data on all SSRI’s.

In response to the announcements by the regulatory agencies, the American College of Neuropsychopharmacology (ACNP), which designated a Task Force in the early 1990’s to review the SSRI trial data, and subsequently published an position paper saying SSRI’s were not linked to suicide, appointed a new Task Force in September 2003, to study the matter again.

This Task Force was made up of many of the same authors whose published papers were under attack for being fraudulent and included Dr John Mann, Dr Graham Emslie, Dr Karen Wagner, Dr Neal Ryan, Dr Andrew Leon, Dr Fredrick Goodwin, Dr David Shaffer, Dr Beardslee, Dr Jan Fawcett, Dr Herbert Meltzer and Dr Ross Baldessarini.

Two weeks before the advisory committee meeting, the Task Force issued a report, once again claiming SSRI’s did not cause suicide, and began making what many experts condemned as preemptive statements in the media to influence the advisory committee to vote against adding a warning about the risk of suicide to SSRI labels.

On January 21, 2007, WebMd’s headline on the internet stated: “Group Finds No Suicide-Antidepressant Link”.

“Our conclusion is that when you look at the SSRI’s as a group, there is evidence they are effective for treating depression in children and adolescents,” Dr Mann told WebMD.

“Instead of being a risk for suicidal behavior, they are potentially therapeutic,” he stated.

In fact, the $30-million Dr Mann, who admitted under oath in a jury trial that it was possible that he got over $30 million in research funding from drug companies over a 10-year period, said the group found strong evidence that SSRI’s help depressed kids and that suicide rates started going down when SSRI’s became available.

He claimed that a 14-year study showed a decline in suicide rates in kids. “Across 15 countries there has been a 33% decline in suicide rates amongst youths,” he told WebMD.

“Doctors must go on treating depression, and SSRI’s appear to be a reasonable choice,” he stated.

The FDA even allowed Task Force members Dr Andrew Leon and Dr Neil Ryan to participate as voting members of the February 2, 2004 advisory panel.

The day after a September 2004 advisory committee finally voted to add a black box warning to the SSRI labels, on September 14, 2004, Senator Grassley issued a press release stating that the FDA “needs to learn an important lesson from what’s developed this year on the matter of kids and antidepressants.”

“Transparency in government is the best policy,” he noted. Parents and doctors should not be left in the dark, and especially when information that’s available could be a matter of life and death.”

“Given the scientific findings,” he added, “it’s obvious that the strongest label warning for this class of drugs is critically important for the health and safety of young Americans.”

“These measures are especially critical,” he said, “since I also understand from previously released studies and from the Advisory Committee’s own deliberations that only one of the nine antidepressant drugs has been proven to provide any benefit to children and adolescents.”

“In fact,” he pointed out, “in almost all cases, the FDA’s own data demonstrates that these drugs actually perform no better than do placebos.”

In a September 16, 2004, letter, Senator Grassley asked the FDA to very quickly and fully consider” the recommendations for the black box and med guides, “before the lives of more children are needlessly lost because parents and others lack adequate, readily understandable information when they most need it.”

He also brought up the issue of informed consent and said he was curious about the FDA’s rationale for not requiring doctors to provide a clear, informed consent document that parents must read, understand and sign before accepting a prescription, as the FDA had done with the drug Lotronex, due to a 1 in 300 risk of ischemic colitis in patients.

In the case of antidepressants, Senator Grassley pointed out, “a suicide-related event involving Prozac (fluoxetine) is about 1 in 15 according to the TADS study, and about 1 in 30 for all SSRI’s, according to FDA’s own study.”

The letter said that the informed consent form should at least include the following points:

(1) Only Prozac has been shown to be effective in treating depression in children and adolescents, and is the only drug approved for this;

(2) All others have been shown to be no different than a placebo, and their use in the treatment of children and adolescents is not an approved use;

(3) All antidepressants increase the risk of suicidality, and

(4) The risk of a suicide event (planned or actually attempted) is one for every 15 to 30 children and adolescents taking the antidepressant.

Senator Grassley also asked what the FDA planned to do about educating doctors and the public about the risk-benefits of antidepressants, especially in children. Obviously, the short answer to that question more than three years later is, not a thing.

In fact, in the January 17, 2008, Wall Street Journal, David Armstrong and Keith Winstein reported that, “the effectiveness of a dozen popular antidepressants has been exaggerated by selective publication of favorable results, according to a review of unpublished data submitted to the Food and Drug Administration.”

“As a result,” they wrote, “doctors and patients are getting a distorted view of how well blockbuster antidepressants like Wyeth’s Effexor and Pfizer Inc.’s Zoloft really work,” in discussing research led by Erick Turner, a psychiatrist at Oregon Health & Science University, published in a study in New England Journal of Medicine.

They also point out that sales of antidepressants total about $21 billion a year.

In all the studies, old and new, which promote the off-label sale of SSRI’s for children with claims that the drugs work and do not cause suicide, almost without fail, the same names appear as investigators and authors. A complete listing includes Dr John Mann, Dr Martin Keller, Dr Graham Emslie, Dr Frederick Goodwin, Dr Karen Wagner, Dr Neal Ryan, Dr Charles Nemeroff, Dr David Dunner, Dr Andrew Leon, Dr John March, Dr David Shaffer, Dr John Rush, Dr Mark Olfson and Dr Robert Gibbons.

This time around, in addition to going after Glaxo for concealing and misrepresenting the data that showed an 8-fold increased risk of suicide, somebody needs to take the bull by the horns and see to it that these industry-funded quacks get thrown in the slammer.

It’s also more than apparent that a few FDA officials belong there as well.

JP Garnier, 5 April 2004 – “I’ll be a hero in three years”…?

When JP Garnier took over GSK as chief executive following the merger eight years ago the share price of GSK was £21 – in October last year the share price was £13.17…

Today the share price is £11.20.

That’s right, during his time as CEO of Glaxo JP has watched the share to fall from £21.00 to £11.20

By anyone’s standards he has failed in the most spectacular manner.

But of course it’s not his fault….

Last Friday Jean-Pierre Garnier, chief executive of GlaxoSmithKline, launched a scathing attack on press coverage of the pharmaceutical industry as the company issued a shock profits warning.

In one of his last presentations before retirement in May, Garnier criticised the reporting of scientific developments and appeared to partly blame journalists for the furore surrounding GSK’s diabetes drug Avandia, sales of which plunged when a study last May linked it to an increase in heart attacks.

“My wish for the media is to be more sophisticated when they report scientific news,” he said at the presentation in London. “Debates now are being thrown into the public domain before scientists have given their opinion.”

Many may disagree with JP on this one – including Aubrey Blumsohn at Scientific Misconduct:

I am a scientist and a doctor Mr Garnier ……. and the science stinks. That’s my opinion. How does one have a “sophisticated” discussion about scientific misconduct?

They just can’t stop themselves – first looking to discredit scientists, then to discredit patients, then to discredit journalists – instead of addressing the shortcomings of their science and ethics.

Never mind the non-transparent science. Never mind the apparent cheating of results in Paxil clinical trials, selective publication of “positive” data, false evidence-free statements made about the safety of Paxil, bullying of academics, witholding of information from prescribers, threats of legal action, involvement with the UK government, and non-existent criminal self investigations. Never mind Keller, Buse, Laden or study 329. Never mind the patients. Never mind the failure to answer actual scientific questions.

I don’t think Matthew Holland agrees either:

Well, who knows, perhaps he knows his audience better than we do? Anyway, he’s got a fucking nerve to demand that “scientists” (all scientists, or just the ones that agree with GSK (I’m thinking of the way that we’re told Garnier orchestrated the slating of John Buse)?), are the only ones who are able to proclaim the truth, and the media should report on what the scientists say, provided that that casts GSK in a good light. I’m sorry: I’ve only to read the correspondence between McCafferty, Oakes, Keller and Laden (who were responsible for the travesty of science that was the write-up of Paxil Protocol 329), to know that, in the context of the sordid world of pharmaceuticals, the view of the experts is worth precisely dick. Besides, if scientists are the only ones who get to say what is true, then patients have no right to speak, and are merely the glad recipients of the great wisdom of the scientists – whereupon we may be fed any old shite, which I imagine would suit Garnier, just fine.

“I’ll be a hero in three years” – JP Garnier, 5 April 2004

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