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.”

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