Dependence on Paroxetine (Paxil/Seroxat)

Dependence on Paroxetine (Paxil/Seroxat)
Statement by David Healy MD FRCPsych

I have been asked to confirm and comment on evidence relating to withdrawal reactions suggestive of physical dependence on paroxetine, observed in studies on healthy volunteers, carried out in the 1980s by SmithKline Beecham.

In the course of a recently settled legal action (Tobin v SmithKline, Wyoming, 2001), I acted as an expert witness for the Plaintiffs. As part of the discovery process I had sought and was granted access to SmithKline’s Beecham’s healthy volunteer archive at Harlow. My concern had been to scrutinise those records for details of possible agitation and suicidality in healthy volunteers taking paroxetine. These were present, but at least as striking was evidence from these studies about dependence on paroxetine.

A detailed expert report was prepared for the plaintiffs’ lawyers in this case, which includes details of studies undertaken by SmithKline Beecham that fully substantiate concerns I communicated to the UK Medicines Control Agency in letters of 7th and 19th June 2001, the essence of which was also accurately reported in The Guardian newspaper (11 June 2001)

I regret that I am under a confidentiality order in regard to this material and am not able to disclose it to this appeal. However, I can confirm, and am prepared to testify to the substance of the points raised in the following exchange (in my testimony in Tobin v SmithKline) between Mr Charles Preuss, the attorney for SmithKline, and myself.

Healy: Yes, but there's a withdrawal syndrome from Paxil, including agitation, abnormal dreams and nightmares that comes through in spades in these healthy volunteer studies.

Preuss: You're saying Paxil is still active for three months?

Healy: In up to 80 percent of the volunteers on this drug for only two weeks produces withdrawal syndromes in these healthy volunteers. I'm saying in my clinical experience I've seen people on this drug for short periods of time and I've seen them have troubles three months later, yes.

My concerns about paroxetine extend far beyond the results of these studies on healthy volunteers. In the 1990s, after its release on to the market as an antidepressant, SmithKline Beecham put paroxetine into clinical trials – exemplified by the study reported by Montgomery & Dunbar, 1993 - that involved a randomised discontinuation design. The difficulties experienced by patients on randomisation to placebo were then interpreted by SmithKline Beecham as evidence of new illness episodes, and the company has subsequently responded to enquiries about the risk of withdrawal reactions and physical dependency, typically by stating that any such problems experienced by patients are simply a recrudescence of their original nervous problem. Basic pharmacological principles, epidemiological studies on depression, as well the evidence from their own healthy volunteer studies strongly suggest that such an interpretation of these data was and is quite unjustified.

Against this background SmithKline Beecham launched paroxetine in the UK with disclaimers on the datasheet to the effect that, as with any drug acting on the brain, some care needs to be taken on discontinuation. The data available to SmithKline before launch indicated problems occurring at a significantly greater rate and to a markedly more severe degree than any psychiatrist at the time would have had reason to expect either from an antidepressant or from such warnings.

Post-marketing surveillance surveys and other studies undertaken since have indicated much greater withdrawal problems with paroxetine than with the previous generation of tricyclic, MAOI and non-tricyclic or non-MAOI antidepressant drugs. A randomised controlled trial undertaken with funding provided by Eli Lilly (Rosenbaum et al, 1998), indicated rates of problems on discontinuation of paroxetine in over 30% of patients with many patients having multiple symptoms, including many novel and disturbing symptoms.

For Dr Wheadon and the company therefore to characterise paroxetine withdrawal reactions as very rare, transient, mild and/or virtually impossible to detect and distinguish from underlying psychiatric illness is simply an untenable position. It follows that I have real concerns about SmithKline promoting paroxetine for the prophylaxis of depressive disorders and other psychiatric illness, on the basis of data that are more sensibly and credibly explained in terms of physical dependence and withdrawal symptoms.

David Healy MD FRCPsych.

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

Sen.Grassley, GSK, Paxil and Martin Keller

Many Seroxat campaigners have previously written about Martin Keller. It's hard to pin down the point in which Keller was caught out... but caught out he was.

For those who don't know, Keller was the 'lead author' of the Paxil 329 study. The upshot of which was that "Paxil was generally well tolerated and effective for major depression in adolescents.”

We now know that isn't true

No prosecution for Keller, in fact he seems to have escaped the justice system... until now.

Sen. Grassley is hot on Keller's heels, and not before time. Grassley seems to have his fingers in many 'hot' pies in the States. He seems to be actually working for the public. A politician with empathy.

There are many stories about Keller out in cyberspace, my only surprise is that it has taken this long to start probing him for answers.

Fingers crossed that Grassley has the staying power because he will be duped, stalled and frustrated if he wants to know the real truth about Keller, Paxil 329 and GlaxoSmithKline.

To read more on Grassley targeting Keller nip over to Pharmalot

Keller is a psychiatrist at Brown University. Dr Aubrey Blumsohn (Scientific Misconduct Blog) knows more about Brown University than most people. Many stories feature on his blog. This link should provide all you need to know about Keller and Brown University.

Matt Holford also writes about Keller and Brown University at the following links:

The Life and Times of Martin B Keller, MD - Part I
The Life and Times of Martin B Keller, MD - Part II
The Life and Times of Martin B Keller, MD - Part III: Brown trousers

A thoroughly insightful read about Keller can be found at the Clinical Psych Blog and I wrote a post entitled, 'Martin B. Keller Good or Evil' back in August last year. Seeing as Grassley is probing I will add it again for the purpose of Grassley's researchers.

Martin B. Keller - Good or Evil?

Sources - Black (1) Red (2)

Dr.Keller is the Mary E. Zucker Professor and Chairman of the Department of Psychiatry and Human Behavior at the Brown University School of Medicine.

Brown University professor who was forced last year to forfeit hundreds of thousands of dollars in state grant money was paid more than $500,000 in consulting fees in 1998, most of it from pharmaceutical companies whose drugs he touted in medical journals and at conferences.

He is also Executive Psychiatrist-in-Chief at the seven Brown University affiliated hospitals.

Dr. Martin Keller of Newton earned more than $842,000 in 1998 while serving as chief of the psychiatry department at Brown, according to financial records. More than half of his compensation came from the pharmaceutical industry, including companies such as Pfizer Inc., Bristol-Myers Squibb, Wyeth-Ayerst, and Eli Lilly, all of which market antidepressants that Keller lauded in a series of medical research reports.

Dr. Keller received his medical training at Cornell University, and completed a medical internship at Bellevue Medical Center in New York City and a psychiatric residency at Massachusetts General Hospital in Boston.

In addition, Keller did not disclose the extent of his financial ties with the companies to the medical journals that published his research in 1998, or to the American Psychiatric Association, which sponsored the meetings at which Keller presented his findings.

His research interests include investigation of nosology and long-term course of psychiatric illnesses, including mood disorders, anxiety disorders and eating disorders, and the effect of treatment of neuropsychopharmacologic compounds and psychotherapy on the short-and long-term clinical course of these illnesses in children, adolescents and adults.

Several ethicists contacted by the Globe say Keller's unusually large consulting fees - he pulled in a total of $556,000 in 1998 and $444,000 in 1997 - constitute the most serious potential conflict they've heard of yet.

Dr. Keller has received over 20 research grants from the National Institute of Health and numerous grants from research foundations and pharmaceutical industry. He serves on numerous professional committees and editorial boards, published over 240 articles for peer-reviewed journals, and has been the recipient of several prestigious awards in recognition of making major contributions to the understanding and treatment of mood disorders.

Keller, meanwhile, is a valuable resource for Brown University, attracting millions in research grants and donations. According to the psychiatry department's annual report and other documents, Keller has brought in about $14.4 million in research funding from pharmaceutical companies and federal agencies since 1993. Approximately $8.4 million has come from the National Institute for Mental Health for research on mental illness.

The most recent honor he received is the 2001 American College of Psychiatrists (ACP) Mood Disorders Lifetime Research Award which he received in February, 2001.

In 1998, Brown was forced to return $300,170 Keller's psychiatry department had collected from Massachusetts for research that state officials say the department never performed. Brown returned the money shortly after the Massachusetts attorney general's office filed a civil lawsuit in Suffolk Superior Court, accusing Brown of breaching research contracts with the Massachusetts Department of Mental Health.

Keller and Study 329:

(3) GlaxoSmithKline conducted a study, numbered 329, in which it examined the efficacy and safety of paroxetine versus placebo in the treatment of adolescent depression. Keller was the lead author on the article (J American Academy of Child and Adolescent Psychiatry, 2001, 762-772) which appeared regarding the results of this study.

(1) - Good?

(2) - Evil?


----

I hope these little snippets of information prove useful to Grassley and his team of investigators.

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

Dear Mr. Woods CEO of the MHRA...

----- Original Message -----
From: fiddaman
To: KENT WOODS
Cc: JOHN WATKINS
Sent: Sunday, June 15, 2008 6:20 PM
Subject: Paxil [Seroxat] Liability Report

Dear Mr. Woods,

Please find attached something that has been in the public domain for over 2 years. I suggest you read it and amend the PIL for Seroxat immediately.

As usual I have blind copied in the main Seroxat 'voices'

Regards

Bob Fiddaman



Related Links:

Paxil Special Report I--"Court Filing Makes Public My Previously Suppressed Analysis of Paxil's Effects." Ethical Human Psychology and Psychiatry, 8, 77-84, 2006.

Paxil Special Report II--"How GlaxoSmithKline Suppressed Data on Paxil-Induced Akathisia: Implications for Suicidality and Violence", Ethical Human Psychology and Psychiatry, 8, 91-100, 2006.

Paxil Special Report III--"Drug Company Suppressed Data on Paroxetine-Induced Stimulation: Implications for Violence and Suicide", Ethical Human Psychology and Psychiatry, 8, 255-263, 2006.

"Suicidality, Violence and Mania Caused by Selective Serotonin Reuptake Inhibitors (SSRIs): A Review and Analysis." International Journal of Risk and Safety in Medicine, 16: 31-49, 2003/2004. Originally published in Ethical Human Sciences and Services, 5:225-246.

Source: http://www.breggin.com/

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

Seroxat and Violence

Examples taken from 'Antidepressants and Violence: Problems at the Interface of Medicine and Law' by David Healy, Andrew Herxheimer, David B. Menkes

Case 2
NH was 18 when prescribed paroxetine 20 mg/day by her general practitioner (GP) in Scotland following the death of her grandmother, at the end of November 2001. Within days, she became markedly somnolent, agitated, and emotionally labile. There was an increasing series of arguments at home, and unprecedented aggression. After eight weeks, her parents, concerned about the situation, brought her back to the GP, who increased the dose of paroxetine to 30 mg. One week after the increase of dose and two months after the initial prescription, NH was involved in an incident at a nightclub in which she assaulted another person.

The dose of paroxetine was reduced to 20 mg. Her behaviour remained unstable, disinhibited, and there was at least one suicidal act. Three months later she stopped treatment. She had significant withdrawal problems, but her behaviour normalised. Having been out of work for close to a year she went back to work and has remained in employment since.
NH pled not guilty by virtue of an automatism.

The case was heard in open court where the jury found her guilty but added "that antidepressants had contributed to her actions on the day in question". The judge imposed a suspended sentence, stating that "but for Seroxat you wouldn't be standing here". This case appears to have involved treatment-induced akathisia.

Case 4
MB was a 33-year-old woman with two children who had untreated nervous problems since her teenage years. In 2001 she approached her GP who prescribed paroxetine. An initial 20 mg dose was increased to 30 mg. MB appeared to become more anxious and agitated. This deterioration led to a switch to venlafaxine, which was successively increased to 300 mg/day. During these increases, the medical notes record her as being more anxious and agitated, but did not link this to treatment.

She made plans to take her own and her children's lives, and taking the children for a drive, attached a hosepipe to the exhaust. In the course of two efforts to execute this plan, she thought better of it and informed both the police and child-care authorities what had happened. Her children were taken into care and she was charged with attempted murder.

During the sentencing in the Supreme Court of Western Australia in April 2004, the judge stated there were substantial grounds for implicating venlafaxine in MB's behaviour, and gave her a suspended sentence [41]. This case again appears to involve treatment-induced akathisia.

Case 6
MC started drinking alcohol socially in 1995 at the age of 17. He used ecstasy in 1999 but stopped after a bad experience. He began using cocaine from February 2001, increasing during October through to June 2002, ultimately using 6 g/day for a short time. After July 2002 MC's cocaine use reduced to nil, apart from four minor relapses. He had none after May 2003. MC's alcohol use increased to four to five cans of lager a night in 2002.

He was prescribed paroxetine 20 mg/day for depression in late May 2002. During the first two months on paroxetine he experienced "terrible shaking of the hands; couldn't pick up a glass of milk without spilling it", felt nausea and had "a constant dull headache, as if squinting in sunlight". When he missed a tablet of paroxetine, he wanted to hide under a duvet and to stay away from everybody; his hands shook, and he had headaches and nausea. These symptoms lasted a couple of days, and he learned not to miss a dose.

In September, his GP increased paroxetine to 30 mg "because he was still very anxious", and advised him to take the paroxetine earlier, when its stimulant effects would be more acceptable, rather than late. He was also started on a regular zopiclone prescription at this point to counter paroxetine stimulation. Soon after, another doctor in the practice changed him to the more sedating dothiepin, but after a few weeks he asked to be put back on paroxetine. He subsequently stopped cocaine but began drinking more heavily. Prescriptions of paroxetine and zopiclone continued through to July 2003.

At this stage he was estranged from an ex-partner with whom he had a now 18-month-old daughter. In August 2003, at her home, after ten pints of lager, he took two zopiclone tablets. Following an argument, they had a pint of beer each, during which there was another bout of quarrelling, and she went to bed alone, leaving him to sleep on the sofa. MC may have taken four more zopiclone tablets. He appeared later that night blood-stained in the local police station with his daughter in his arms. The police found his partner dead from multiple stab wounds. He was charged with murder.

In prison paroxetine 30 mg was continued; zopiclone was stopped. During his initial period on paroxetine, and then in prison, MC complained of "terrible nightmares, waking dripping with sweat, soaking the bed". Intense frightening nightmares have been reported regularly in healthy volunteers taking paroxetine. MC had no reported episodes of sleepwalking before using paroxetine, but he had a number of documented episodes of sleepwalking after starting the drug, and two first-degree relatives had a history of sleepwalking. Sleepwalking has been reported in association with zolpidem, a hypnotic related to zopiclone [42–44], but no case of sleepwalking on zopiclone has been reported in the scientific literature. However, as noted above, zopiclone is the drug most commonly linked to sleepwalking in Yellow Card reports to the MHRA.

Clearly violence follows domestic arguments, and is a known effect of alcohol, but this case offers grounds also to implicate paroxetine and zopiclone. Zopiclone is known to cause a dose-dependent confusion and amnesia comparable to that found with benzodiazepines [45]. Violence cannot however be attributed to a direct effect of paroxetine alone, since MC had been maintained on this for almost one year with no prior violence. In these circumstances MC pleaded guilty at his trial on 27 February 2006. The judge did not accept that paroxetine and zopiclone had played any part, and sentenced him to 13 years prison. An appeal against the sentence is being prepared.

Case 9
According to an independent forensic report compiled a year after the events for which CP was charged in November 2001, CP was a 12-year-old, 5'2", 95-lb boy with a family background involving considerable social dislocation. Despite the difficulties of his social situation, he had no record of treatment for nervous disorders or of violence or behavioural disturbance. Following an argument with his father at the end of October 2001, he was admitted to a behavioural centre for six days where he was started on paroxetine. His behaviour worsened daily on paroxetine. He was discharged against medical advice to the care of his grandparents, who, when his paroxetine ran out, took him to their primary-care physician who prescribed sertraline 50 mg, increasing this to 100 mg two days before the killings for which CP was charged. The duration of sertraline treatment was three weeks.

Hat Tip to The Truthman for sending me this.

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

GlaxoSmithKline, David Healy & Shelley Joffre

On the 1st November 2007 Panorama reporter Shelley Jofre discussed her investigations into the effects of psychiatric drugs and questioned how much faith we should put in the medicines we take. This took place at Coventry University here in the UK and is available via a podcast.

Very interesting podcast it is too, where you will learn much about what Shelley Jofre and David Healy have saw with their own eyes but for legal reasons are not allowed to disclose. Who told them not to? GlaxoSmithKline did!

Shelley became intrigued with Seroxat when she read a small piece in a newspaper in the year 2000, the article was about patients complaints with Seroxat - almost 8 years ago people! Even back then people were complaining that it was difficult to withdraw from and were suggesting that it was addictive.

She goes on to tell the audience that the filming of the first Panorama Seroxat 'Special' Secrets of Seroxat took 8 months to finish. She states that the first programme pretty much relied on the testimony of one man who was Dr David Healy and what was unique about his position was tha he, through a series of legal actions in the United States, had actually been given access to GlaxoSmithKlines 'secret archives', a wealth of confidential material.

All the results of trials they had run before Seroxat had been licensed were in huge vaults and Healy, through American litigation, was granted 3 days to look through the records.

The rest, as you all know is history. Healy's evidence at the Tobin v. GlaxoSmithKline trial , No. 00-CV-0025 (D. Wyo. June 6, 2001) was pretty damning for Glaxo. It resulted in GlaxoSmithKline being found 80% guilty of causing the deaths of Donald Schell's wife, daughter and granddaughter.

David Healy could only relay to Shelley Jofre what he had relayed in the United States courtroom. What he spoke about in court opened Shelley's eyes. Glaxo were of course in a position to argue that it was the illness that had caused Schell to murder his wife, daughter and granddaughter but Healy had found that that Glaxo had done tests on normal, healthy people, even their own employees. These tests seperate out the effects of the illness from the effects of the drug, ie; if you're not depressed why would you then become suicidal or have homicidal thoughts if given a course of Seroxat?

What Healy had found in the healthy volunteer studies was that it was making some people have suicidal thoughts and become aggressive and also the some of the healthy volunteers were having trouble when withdrawing from Seroxat. Compelling evidence I'm sure you'll agree.

Shelley also mentions her 3 interviews with Glaxo mouthpiece, Alistair Benbow. One thing I never spotted before, and kudos to Shelley's observation skills here, was the second programme where Benbow (obviously briefed by Glaxo's lawyers and PR Team) was seen to have a more laid back approach. Head tilted to one side, his collar open, speaking in a sympathetic voice. Watching the video again I can see exactly what she means.

Shelley also speaks of the MHRA - It's a fascinating interview and one that no doubt I will play over and over. The woman deserves honours of the highest order for cracking open GSK... as does David Healy

The podcast can be downloaded here

Fid

MHRA - What more do you want?

I've banged the drum enough times about the utter incompetence of Kent Woods and the MHRA - Why?

Well they are into there fourth year investigating GlaxoSmithKline despite overwhelming evidence that clearly shows how GlaxoSmithKline secretly planned to push Seroxat onto an unsuspecting public despite the myriad of side effects known to them.

Once again this post goes out to the CEO of the MHRA - Just in case he missed it first time around.

Lets go back to November 7th 2004 and show you an article from The Observer - The MHRA would have only been a year into their investigation when this was published and probably at that time thought they could push it under the carpet - little did they know that advocates such as myself, Seroxat Secrets, Charles Medawar et al would be on their case pushing them... no, demanding them for answers.

FOR YOU MR KENT WOODS:
(I have highlighted (in red) points you may wish to discuss/investigate with your colleagues)

Britain's largest drug company drew up a secret plan to double sales of the controversial anti-depressant Seroxat by marketing it as a cure for a raft of less serious mental conditions, The Observer can reveal today.

The contents of the 250-page document have alarmed health campaigners who accuse the firm, GlaxoSmithKline (GSK), of putting profit before the therapeutic needs of patients by attempting to broaden the market for the drug which has been linked to a spate of suicides.

The revelation is likely to prompt further concerns about the role and influence of the pharmaceutical industry, which has come under severe scrutiny in recent months. The document is now being investigated by a parliamentary inquiry into the drugs industry.

The internal report carries a section which outlines how GSK planned to double sales of 'selective serotonin reuptake inhibitors (SSRI)' - the industry term for anti-depressants - by winning the marketing war against Seroxat's chief rival, Prozac, manufactured by Eli Lilly.

Written in 1998 and subsequently updated in following years, the section is entitled: 'Towards the second billion - all SSRIs are not the same' and discusses strategies to see off the threat posed by Prozac.

The document outlined how GSK intended to market Seroxat for a range of conditions other than clinical depression. Chief among these was a condition the company identified as social anxiety disorder, although other forms of anxiety were also discussed internally.

'What this document makes clear is that a number of different forms of anxiety were being targeted in a systematic way. The thrust was to move sales beyond the $1 billion to $2 billion mark by pushing it to people who were not clinically depressed,' said Professor David Healy, a psycho-pharmacologist at Cardiff University, who has given evidence to the House of Commons Health Select Committee.

Richard Brook, chief executive of Mind, the mental health charity which submitted the document to the committee, told the MPs it was 'all about developing new conditions for that drug and demolishing the arguments of other competitors about why their drug was not any good'.

In addition the document shows GSK made a great virtue of the fact that Seroxat had a relatively short 'half-life' compared with Prozac, an argument which has subsequently proven deeply controversial.

A half-life is the scientific term for how long it takes for the concentration of a drug to drop by 50 per cent in a patient's bloodstream. The company suggested Seroxat's short half-life meant patients could come on and off the drug easily, compared with those on Prozac, even to the extent that they could take 'treatment holidays'. 'There was an argument that a short half life was really good news,' Brook said.

'But five years later, Seroxat has withdrawal issues. It's the short half life that causes the problems. The substances get into the body so quickly it causes some sort of dependency reaction. So one of the things the company was saying was a benefit was actually a problem.'

In its submission to the parliamentary committee Mind said the original trial data submitted to the UK regulators by GSK showed the claim was at best 'naive and at worst seriously misleading'. It added that 'the Seroxat file is highly illustrative of using marketing information as facts'.

Concerns about the addictive properties of Seroxat saw the government ban its prescription to people under the age of 18 last year. This followed a review which found children taking it were more likely to self-harm or commit suicide.

A spokesman for GSK said Seroxat could be marketed at new conditions only after stringent testing. 'Medical authorities around the world have required that GSK study each condition separately in order to prove benefit in each condition specifically.'

Hope this helps you Kent

Happy New Year

Fid

Aropax Hell Part II

It seems the word is spreading throughout Australia.

This is an account taken from the firesnake website, I urge yo to visit, the guy has obviously done his homework when it comes to Paxil 329 study.

I've republished it here in its entirety, hope the author does not mind.

----

Yes, Aropax kills. In this second part of 'Aropax Hell' we touch on the behind the scenes documentation and "The" memo - "it would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine" - that exposed GSK's intention to place the money before the box - as it were. A concerted plan to educate sales rep's from wavering under the strain of humane thoughts was launched. We know it's the fourth most addictive drug on the planet. And we pay good money, for a drug that makes well subjects anxious and depressed to the point of suicide, and has no effect upon depression at all.

Justifiably, criminal charges followed. It is plain Paroxetine must be considered carefully. European Paroxetine Q&A here.
Why was it reviewed? What are concerns? What's the evidence?

We touch on Study 329 which produced the very data GSK decided to hide. Self harm, highly addictive and non-efficacy: things look bad for paroxetine. Problems continue to unfold and GSK released studies "showing suicide, hostility, etc". It's clear that the jury verdict [original document] holding GSK 80% liable for the murder-suicide case of Donald Schell was reported widely and led to the BBC Panorama investigation - which actually continues in court today [timeline]. The argument over addiction or discontinuation semantics proceeds splendidly with the courts eventually catching on to the shortfalls of addiction definitions.

For those involved on the inside, it's a bizarre ride. Aside from the raft of personality fragmentation even modest struggles with paroxetine induce, it is clear this induces suicide and self sabotage in previously stable or asymptomatic persons. We can see a gradual "chronology of admission" as GSK confirms dangers effect all ages and quietly reveal it's a major risk during pregnancy. At last after more time - and possibly energy - than earning a PhD, GSK admit what we wanted: paroxetine is an absolute tragedy regardless of age, and kills without compunction. Thankfully, the FDA agree.

Annoying the FDA is kinda silly and when Eliot Spitzer was given the run around by GSK over paroxetines inefficacy, one imagines his blood boiled. Ultimately, Spitzer lodged a class action [original PDF] on behalf of New York residents deceived by GSK. The FDA succeeded in agitating for close reviews of paroxetines trials: the famous and detailed Article 31. This episode includes more out-takes of Dr. Alistair Benbow lying heroically as authours drag his name through mud [2]. GSK itself continually releases token "warnings" and basks in the credit-for-responsibility spotlight.

Firesnake also looks closely at SSRI induced aggression, depression per se, what we know of Donald Schell, his mood swings, prior medication, SSRI blood levels and time needed to observe any effect of any SSRI - no matter how inefficacious. Paroxetine may be a useless SSRI, but an SSRI it is. Did Schell kill and suicide as a direct result of paroxetine? Or, did justice really catch up with GSK due to illegal business practices and appalling ethics, revealed in so much damning documentation? If the latter, legal purists may find this challenging, but none can deny paroxetine was going to kill, did kill thousands of others, destroyed lives, families, careers and if not for dedicated advocates, we may never know. Firesnake considers the only conclusion possible, and reflects upon "justice" - no matter how it comes.

Australians must be proactive. Ethnocentric, we are blind to global dynamics and receive a filtered trickle of data. I myself have brilliant colleagues, who still, in blind error and with no small amount of defensive, guilt-in-hindsight-arrogance, insist paroxetine's safe. Why? They are busy, prone to follow "best practice" over evidence based practices, meet the needs of pestering patients, staff, colleagues, employers, registrars, ethics committees and of course, the drug companies that paid for their beach front property with decades of obscene perks. And let's not forget because the company blurb says so - and to ever admit the reality is to invite litigation.

If your GP, psychiatrist or gym instructor prescribes or recommends Aropax, take your business - and life quality - elsewhere; that person is genuinely mistaken.

Our TGA is silent, yet vocal on Straterra - the type of medication one leap up from SSRI's targeting norepinephrine also. Read the documentation, find your own answers. Never use paroxetine - but it is your choice.

Woman sues GlaxoSmithKline over husband's suicide

Click here to view a copy of the lawsuit.

Aropax Australia

Seem to be getting a lot of hits from Australia and New Zealand of late. This pleases me as here we have two countries that have been pretty much kept in the dark about the dangers of GlaxoSmithKline's 'wonder drug'. Known as Aropax, it is still being prescribed to children down under as the TGA refuse to send out 'Dear Doctor' letters. Even GlaxoSmithKline, Australia still tout out the now defunct serotonin imbalance theory!

The following links are for our friends down under. Help spread the word and put pressure on your own medicines regulator to do something about this drug.

Medicines Australia & The TGA Looking In

GSK Australia continue to dupe their public!

Still no reply from...

Delphi Centre, GSK and the TGA

The Delphi Centre & GlaxoSmithKline Advertising

Aropax (Seroxat) - The Bitterest Pill?

Love That Aropax Smile

GSK Advertise Seroxat for Red Nose Day

SSRIs and their Complications down under

GlaxoSmithKline Money Trail Down Under Part 4 - Enter Dr Martin Keller

GlaxoSmithKline Money Trail Down Under Part 3

GlaxoSmithKline Money Trail Down Under Part 2

GlaxoSmithKline Money Trail Down Under Part One

Liebenagate - The excuse! (How GSK duped the New Zealand public)

Another Ian Hudson Scenario?

16 year old directed to the truth.

Video for Australian & New Zealander Visitors to this Blog

Don't forget to trawl through the archives section in the right hand column.

Fid

Seroxat Side Effects

Over 2800 reported cases now online - HERE

"Patients have nothing to fear when taking Seroxat" - Alistair Benbow, Head of European Clinical Psychiatry for GlaxoSmithKline

16 year old directed to the truth.

Comment left by one of my readers.


Sonic has left a new comment on your post "Seroxat Down Under (Aropax)":

I have been a little down for a while now, i wouldn't call it severe depression at all.

I went to the doctor with mum (i am 16) and mum went on about how she thinks I could be depressed and how the councilors at school think i may be too.

He pretty much heard the word 'depression' and began writing a perscription for aropax. He wouldn't even listen to me. Anxiety? as in? Severe worry? Sure.. i worry, but i don't think its severe. I defintely dont have social problems and am good at making new friends and speaking.

Anyway, I thought he was an idiot, he didnt analyze me at all before he gave me this prescription. He said take half a tablet for 4 days and then after that 1 tablet a day.

And he said "Within the first week you will have suicidal thoughts". I mean gosh, my mum was in there with me and that worried her a lot.

So, after we left I said to mum that I am not taking this drug because I do not suffer from sever anxiety and that guy was an idiot. But mum insisted I should anyway.

Came home, looked it up, found this blog and the wikipedia of it. holly fuck.

There is no bloody way I am going on this stuff. No bloody way. And I can't believe he didnt warn me about all of the side effects and how addictive it is. I asked if it was addictive and he said it wasn't. Fucking idiot. Anyway, just posting to thank you for revealing your story to bring awareness of what this drug can do.

Posted by Sonic to SEROXAT SUFFERERS - STAND UP AND BE COUNTED at 3:26 PM

Daily Mail Seroxat Links

1 Can antidepressants be found in breast milk?
Your concerns about your grandson are understandable especially in the light of the recent media coverage about Seroxat. .....read

2 Seroxat ban for children
by ROSALIND RYAN, femail.co.uk - 10/06/2003
Depressed children should not be prescribed Seroxat because the controversial drug raises the risk of self-harm and suicidal thoughts in under-18s, according to a new report.....read

3 Man slashed wrists after two weeks on anxiety pill By James Tozer Coroner calls for leading anti-depressant to be withdrawn
14/03/2003
A CORONER has called for Britain's biggest-selling antidepressant to be withdrawn after a retired headmaster who was prescribed the drug was found dead with slashed wrists. .....read

4 Agency blamed for promoting Seroxat
08/05/2003
The body which regulates medicines is playing Russian Roulette with people's lives over the common antidepressant drug Seroxat, a charity claimed today.....read

5 Seroxat warning to under-18s
10/06/2003
Under-18s should not be given the anti-depressant Seroxat as the risk of suicidal thoughts and self harm is up to three times higher among those on the drug, experts said......read

6 Sufferers sue 'happy pill' firm for £30million
By MARTIN DELGADO - 17/11/2007
Pharmaceutical giant Glaxo-SmithKline is facing a £30million damages claim from users of its anti-depressant Seroxat. Lawyers representing patients who insist the drug is addictive have issued the first of 600 High Court writs against the company.....read

7 DoH: 'Seroxat 'link' to suicides'
29/05/2003
UK health professionals have raised concerns about possible links between the anti-depressant drug Seroxat and eight cases of suicide, say the Department of Health.....read

8 Shamed Glaxo's u-turn on 'suicide' drug
by BEEZY MARSH and TIM UTTON, Daily Mail - 15/06/2004
Britain's biggest drugs firm has revealed research that shows a leading anti-depressant can cause children to attempt suicide. Glaxo-SmithKline is facing a major lawsuit amid allegations that drug regulators were duped into thinking Seroxat was safe for children.....read

9 Anti-depressant drug linked to increase in suicides
22/08/2005
Thousands of patients taking an anti-depressant have been put on alert after the drug was linked to a worrying rise in suicides. Seroxat has been the subject of previous warnings that it may make children more suicidal, but researchers now say that should be extended to adults.....read

10 Drug giant 'covered up safety fear on Seroxat'
29/01/2007
A drugs firm covered up vital evidence about thesafety of an anti-depressant linked to a string of suicides, it has been claimed .....read

11 Patients 'hooked on the shy pill'
17/09/2002
The makers of a widely prescribed 'anti- shyness pill' face legal action over say it is addictive. Around 900 patients claim they suffered distressing withdrawal symptoms after taking Seroxat.....read

12 Why I resigned over 'happy pill' cover-up
by RICHARD BROOK, Daily Mail - 23/03/2004
The Government knows Seroxat anti-depressants can be dangerous. When one expert was asked to hide the truth, he quit.....read

13 Why you should never trust new wonder drugs
06/02/2007
A drug company was last week accused of concealing evidence about the safety of a drug. According to Professor David Healy, this is just the latest case where patients and medical professionals have been misled .....read

14 The 'happy pill' kids
by JENNY HOPE, Daily Mail - 18/11/2004
Soaring numbers of British children are being prescribed anti-depressants and other mind-altering drugs, research reveals today. Some experts fear that drugs are being given too readily to youngsters after the UK saw the biggest rise in the world in prescriptions.....read

15 Medicines watchdog 'failed patients'
04/10/2004
The UK medicines watchdog has been accused of failing to protect patients using the anti-depressant drug Seroxat. A programme claims past trials showed that the drug can leave a quarter of users addicted, while rapid increases in its dosage can cause serious side effects.....read

16 Probe into 'addictive' anti-depressant drug
by RACHEL ELLIS, Mail on Sunday - 15/12/2002
After months of pressure, the Government is setting up an investigation into Britain's most widely prescribed anti-depressant, Seroxat. .....read

17 Suicide link = child drugs ban
by PAUL SIMS, Evening Standard - 10/12/2003
GPs have been banned from prescribing children antidepressants after new evidence found the drugs may promote suicidal behaviour. The government says nearly all are risky.....read

18 How can we treat depression naturally?
On a dietary level, it might help your husband to cut back on or eliminate from his diet certain foodstuffs which tend to upset brain chemistry. .....read

19 Anti-depressant 'linked to suicides'
29/05/2003
Health professionals in the UK have raised concerns about possible links between the anti-depressant drug Seroxat and eight cases of suicide over the past three years, the Department of Health said......read

20 Record numbers of children prescribed anti-depressants
By DUNCAN ROBERTSON - 23/07/2007
The number of school children prescribed anti-depressants and mind-altering drugs has more than quadrupled in the last decade. New figures show GPs are prescribing pills in record numbers to combat stress, violent behaviour and even tiredness.....read

21 Elderly patients who take anti-depressants run a higher risk of getting osteoporosis
25/06/2007
Elderly patients who take anti-depressants run a higher risk of getting osteoporosis, it has emerged. Two studies found that patients who used drugs such as Prozac and Seroxat developed thinner bones.....read

22 A guide to Britain's most popular antidepressant
11/03/2002
Below is a guide to the most commonly prescribed anti-depressants in the UK. .....read

23 Doctors hand out a record 31m anti-depressant prescriptions
by DUNCAN ROBERTSON - 14/05/2007
Prescriptions for anti-depressant drugs are at a record high, despite warnings that many people would benefit more from alternative treatments.The use of drugs such as Seroxat and Prozac increased by 10 per cent last year .....read


Remember GSK's recent quotes regarding the recent press release that Lawyers representing patients who insist the bestselling drug is addictive have issued the first of 600 High Court writs against the company?

Let me refresh your memories:

GlaxoSmithKline said: "Seroxat has benefited millions of people worldwide.

"We believe the product is not defective and that there is therefore no merit in this litigation."

Hmmm.

DENIAL

DENIAL

DENIAL

Martin B. Keller - Good or Evil?

Sources - Black (1) Red (2)

Dr.Keller is the Mary E. Zucker Professor and Chairman of the Department of Psychiatry and Human Behavior at the Brown University School of Medicine.

Brown University professor who was forced last year to forfeit hundreds of thousands of dollars in state grant money was paid more than $500,000 in consulting fees in 1998, most of it from pharmaceutical companies whose drugs he touted in medical journals and at conferences.

He is also Executive Psychiatrist-in-Chief at the seven Brown University affiliated hospitals.

Dr. Martin Keller of Newton earned more than $842,000 in 1998 while serving as chief of the psychiatry department at Brown, according to financial records. More than half of his compensation came from the pharmaceutical industry, including companies such as Pfizer Inc., Bristol-Myers Squibb, Wyeth-Ayerst, and Eli Lilly, all of which market antidepressants that Keller lauded in a series of medical research reports.

Dr. Keller received his medical training at Cornell University, and completed a medical internship at Bellevue Medical Center in New York City and a psychiatric residency at Massachusetts General Hospital in Boston.

In addition, Keller did not disclose the extent of his financial ties with the companies to the medical journals that published his research in 1998, or to the American Psychiatric Association, which sponsored the meetings at which Keller presented his findings.

His research interests include investigation of nosology and long-term course of psychiatric illnesses, including mood disorders, anxiety disorders and eating disorders, and the effect of treatment of neuropsychopharmacologic compounds and psychotherapy on the short-and long-term clinical course of these illnesses in children, adolescents and adults.

Several ethicists contacted by the Globe say Keller's unusually large consulting fees - he pulled in a total of $556,000 in 1998 and $444,000 in 1997 - constitute the most serious potential conflict they've heard of yet.

Dr. Keller has received over 20 research grants from the National Institute of Health and numerous grants from research foundations and pharmaceutical industry. He serves on numerous professional committees and editorial boards, published over 240 articles for peer-reviewed journals, and has been the recipient of several prestigious awards in recognition of making major contributions to the understanding and treatment of mood disorders.

Keller, meanwhile, is a valuable resource for Brown University, attracting millions in research grants and donations. According to the psychiatry department's annual report and other documents, Keller has brought in about $14.4 million in research funding from pharmaceutical companies and federal agencies since 1993. Approximately $8.4 million has come from the National Institute for Mental Health for research on mental illness.

The most recent honor he received is the 2001 American College of Psychiatrists (ACP) Mood Disorders Lifetime Research Award which he received in February, 2001.

In 1998, Brown was forced to return $300,170 Keller's psychiatry department had collected from Massachusetts for research that state officials say the department never performed. Brown returned the money shortly after the Massachusetts attorney general's office filed a civil lawsuit in Suffolk Superior Court, accusing Brown of breaching research contracts with the Massachusetts Department of Mental Health.

Keller and Study 329:

(3) GlaxoSmithKline conducted a study, numbered 329, in which it examined the efficacy and safety of paroxetine versus placebo in the treatment of adolescent depression. Keller was the lead author on the article (J American Academy of Child and Adolescent Psychiatry, 2001, 762-772) which appeared regarding the results of this study.

(1)

(2)

Seroxat Archives: FDA Will Probe SmithKline On Pitch for Unlicensed Drugs

Thanks to the Truthman for digging this up.

Source: Washington Post 1991

FDA Will Probe SmithKline On Pitch for Unlicensed Drugs

SmithKline last month held three sessions in Baltimore in which a "marketing consultant" met with doctors to discuss nabumetone, a pain-killer and anti-inflammation drug the company is developing. Three more meetings are planned for this month to discuss paroxetine, an antidepressant. Neither has been approved by the FDA.

"Priming prescribing doctors to be poised to write prescriptions for a drug whose safety and effectiveness have not been established to FDA's satisfaction is a practice which FDA has clearly stated to be illegal," Sidney M. Wolfe, a physician and director of the Health Research Group, wrote to FDA Commissioner David A. Kessler. Wolfe asked Kessler to "promptly initiate criminal prosecution" of SmithKline.

"If we find that the invitation was sent out to a large number of physicians," an FDA spokesman said, "it would be considered a promotional activity and not legitimate marketing research. In that case, it would probably violate FDA rules regarding promotion of unapproved drugs."

GSK - committed to improving the quality of human life

Jeffrey Dach MD

A word from Jeffrey Dach MD.

Jeffery left this comment after my post 'When the rot set in at GlaxoSmithKline'

The particular post recieved a lot of interest from pharmaceutical companies and lawyers visiting this blog so much so that Jeffery's comment was overlooked. Anyway, here it is:


According to Dr. Irving Kirsch in Prevention & Treatment, “there is now unanimous agreement that the mean difference between response to SSRI antidepressant drugs and response to inert placebo is very small. It is so small that, despite sample sizes involving hundreds of participants, 57% of the SSRI trials funded by the pharmaceutical industry failed to show a significant difference between drug and placebo. Most of these negative data were not published and were accessible only by gaining access to US Food and Drug Administration (FDA) documents.

Various methods were used to manipulate the results of SSRI drug studies to insure a favorable outcome:

1) Responders to the placebo are eliminated at the beginning of the study. (Placebo washout)

2) Benzodiazepine sedatives were given to mask the SSRI induced agitation.

3) Unfavorable drug studies are buried in the file cabinet and not disclosed to the public.

4) Miscoding suicidal events as "emotional lability", and homicidal events as "aggression" to hide suicidal events from regulators.

5) False attribution of suicide to the placebo arm.

6) Hiring ghost writers to make the medical articles more favorable.

7) Cash settlements for SSRI drug litigants which seals records and withholds unfavorable drug studies from the public.

For more information and links see my Paxil, Prozac, and SSRI Induced Suicide Newsletter

Jeffrey Dach MD


Doncha just love number 7?

Fid

Paxil Recall Lawyer Discusses Paxil Addiction

Source: Ezine Articles

By Anna Henningsgaard

Paxil went on the market in 1992 at the height of antidepressant drug popularity. It is a member of the class of antidepressants called selective serotonin reuptake inhibitors, or SSRIs. The SSRI drugs revolutionized antidepressants because they have very few side effects and it is practically impossible to overdose on them. It makes sense not to prescribe a depressed person with pills they can easily overdose with. Though a latecomer to the SSRI market, Paxil grew successful very quickly by gaining FDA approval for very specific conditions like “social anxiety disorder” and “general anxiety disorder”, which were very rare conditions at the time. In running add campaigns, Paxil encouraged people to try their drug if they’d experienced any general anxiety and, as can be expected, sales of Paxil soared.

Commercials for Paxil insist that the drug has no side effects and is not addicting, major selling point. Many doctors and pharmacies will tell you the same thing, that Paxil is not addictive. To the contrary, many patients using Paxil have found it very difficult to quit. Even slowly reducing doses and coming off the drug, many patients have complained of intense stomach pains, diarrhea, intense anxiety, anger, migraines, and an odd electrical zapping whenever they move their heads or eyes. These symptoms are often written off as temporary illness due to discontinuity. After a few months, the symptoms will be diagnosed as a relapse of depression, and what could be prescribed for that? Paxil.

A recent independent study found that as many as 50% of Paxil users experience intense withdrawal from the drug. While some other drugs in the same class, like Prozac and Zoloft, cause similar withdrawal reactions none of them cause reactions this intense. This could be because Paxil has a much shorter half-life than the other antidepressants, and more addicting substances often have short half-lives. The brain likes slow adjustments and cannot handle rapidly changing chemicals.

Class action lawsuits have been filed against Paxil in Britain as well as the United States. The company that produces and markets Paxil refuses to acknowledge that it can be a habit-forming, addictive drug and has not changed its packaging or advertising despite recent cases of addiction. Patients often find no help from doctors or pharmacies, who simply tell them that Paxil is marketed as a non-addictive drug and, for that reason, cannot cause the symptoms being experienced. If you have been put in this uncomfortable position, contact a lawyer and discuss your situation. A class action lawsuit that began with 35 people has grown to over 2000 people, so you are not alone by any means. Talking with a lawyer can make you feel better and give you some hope for justice.

July 2007 – "MANIA: The shocking link between psychiatric drugs, suicide, violence and mass murder"

Source: Whistleblower

From Columbine to Virginia Tech, every time another headline-making mass murderer is discovered to have taken antidepressants or other psychiatric drugs, rumors and speculation abound regarding the possible connection between the medications and the violence.

Now, reports the July 2007 edition of WND's elite monthly Whistleblower magazine, the time for speculation and guessing is over. The evidence is overwhelming and irrefutable, says Whistleblower's groundbreaking investigative report: Mood-altering psychiatric drugs – taken every day by tens of millions of Americans, including millions of children – actually can push some users over the edge into mania, suicide and horrific violence.

The issue is titled "MANIA: The shocking truth about psychiatric drugs and their link to suicide, violence and mass murder."

To begin with, many of the most notorious mass killers in recent memory have been on, or just coming off, prescription mood-altering drugs. Remember these headline names?

Andrea Yates, in one of the most heartbreaking crimes in modern history, drowned all five of her children – aged 7 years down to 6 months – in a bathtub. Insisting inner voices commanded her to kill her kids, she had become increasingly psychotic over the course of several years.

Yates had been taking the antidepressant Effexor. In November 2005, more than four years after Yates drowned her children, Effexor manufacturer Wyeth Pharmaceuticals quietly added "homicidal ideation" to the drug's list of "rare adverse events." But "rare" is defined by the FDA as occurring in less than one in 1,000 people. And since, according to an Associated Press report, about 19.2 million prescriptions for Effexor were filled in the U.S. alone in 2005, that means statistically almost 20,000 Americans could experience "homicidal ideation" – that is, murderous thoughts – as a result of taking just this one antidepressant drug.

Columbine mass-killer Eric Harris was taking the widely prescribed antidepressant Luvox when he and fellow student Dylan Klebold went on a hellish school shooting rampage in 1999, killing 12 students and a teacher and wounding 24 others before turning their guns on themselves.

Luvox manufacturer Solvay Pharmaceuticals concedes that 4 percent of children and youth taking Luvox developed "mania" – a serious mental derangement characterized by extreme excitement and delusion – during short-term controlled clinical trials.

Authorities investigating Cho Seung-Hui, who murdered 32 at Virginia Tech in April, reportedly found "prescription drugs" for the treatment of psychological problems among his possessions. Joseph Aust, Cho's roommate, told the Richmond Times-Dispatch Cho's routine each morning had included taking prescription drugs.

So what kind of meds had Cho been taking? Strangely, his medical records have yet to be released to the public – authorities claiming it's because an investigation is still ongoing, although critics suggest the purpose may be to protect the drug companies from liability claims.

Meanwhile, the list of killers who happened to be taking psychiatric medications is long and chilling. Remember these headline names?

Patrick Purdy's 1989 schoolyard shooting rampage in Stockton, Calif., was the catalyst for the legislative frenzy to ban "semiautomatic assault weapons" in California and the nation. The 25-year-old Purdy, who murdered five children and wounded 30, had been on Amitriptyline, an antidepressant, as well as the antipsychotic drug Thorazine.

Kip Kinkel, 15, murdered his parents in 1998 and the next day went to his school, Thurston High in Springfield, Ore., and opened fire on his classmates, killing two and wounding 22 others. He had been prescribed both Prozac and Ritalin.

In 1988, 31-year-old Laurie Dann went on a shooting rampage in a second-grade classroom in Winnetka, Ill., killing one child and wounding six. She had been taking the antidepressant Anafranil as well as Lithium, long used to treat mania.

In Paducah, Ky., in late 1997, 14-year-old Michael Carneal, son of a prominent attorney, traveled to Heath High School and started shooting students in a prayer meeting taking place in the school's lobby, killing three and leaving another paralyzed. Carneal reportedly was on Ritalin.

In 2005, 16-year-old Native American Jeff Weise, living on Minnesota's Red Lake Indian Reservation, shot and killed nine people and wounded five others before killing himself. Weise had been taking Prozac.

In another famous case, 47-year-old Joseph T. Wesbecker, just a month after he began taking Prozac, shot 20 workers at Standard Gravure Corp. in Louisville, Ky., killing nine. Eli Lilly, which makes Prozac, later settled a lawsuit brought by survivors.

All very interesting, you may be thinking, but what do the drug companies say in their defense?

One of the most widely prescribed antidepressants today is Paxil, manufactured by GlaxoSmithKline.

Paxil's known "adverse drug reactions" – according to the drug's own 2001 FDA-approved label – include "mania," "insomnia," "anxiety," "agitation," "confusion," "amnesia," "depression," "paranoid reaction," "psychosis," "hostility," "delirium," "hallucinations," "abnormal thinking," "depersonalization" and "lack of emotion," among others.

With a rap sheet like that, no wonder pharmaceutical companies are nervous about liability lawsuits over the "rare adverse effects" of their medications. In 1998, for example, GlaxoSmithKline was ordered to pay $6.4 million to Donald Schnell's surviving family members after the 60-year-old man, just two days after taking Paxil, murdered his wife, daughter and granddaughter in a fit of rage.

But reporting the truth about the relationship between psychiatric medications and mass murderers is just the beginning. "MANIA" also reveals clear and compelling evidence that psychiatric drugs hurt children physically – causing shrinkage of their brains, damage to their hearts and other significant effects.

Perhaps even more disconcerting, "MANIA" exposes the federal government's bizarre preoccupation with screening all American school kids to see if they're mentally ill – a process that often leads directly to a prescription for mood-altering drugs for the child who didn't answer the questions properly.

"The problem," said David Kupelian, managing editor of WND and Whistleblower, "is that many Americans don't exactly trust the federal government to determine what constitutes 'mental health.'" Incredibly, as this issue reveals, there is even a government effort to proclaim an infant-and-toddler mental health crisis!

With the numbers of people taking prescription psychiatric medications in the tens of millions and growing every day, this issue will touch virtually every reader in a profound way.

"I think this is one of the most important and frankly mind-boggling editions of Whistleblower we've ever produced," said Kupelian. "The information in it could very well be life-changing – or even life-saving."

Note: You can also order a subscription to Whistleblower magazine.

GlaxoSmithKline Pushes Depression Drug

by Shelley Jofre, Special to Corp Watch

July 30th, 2007


A striking young woman with a talent for painting, Sharise Gatchell was - like many teenagers - painfully self-conscious. At 14, she moved with her family from South Africa to England where at first she found it hard to make friends. By the age of 16 she was acutely embarrassed that her periods hadn't started and felt she was sweating excessively. Just the sort of thing to make adolescence even more painful than usual. Her mother, Stephanie, took her to see a consultant physician at the local hospital. Stephanie Gatchell recalls:

"During that consultation she became a bit emotional because she was explaining to him about the problems she had and how it affected her social life. Then she started crying and I was amazed. He asked her, 'Sharise, do you sometimes feel like ending it all?', and I couldn't believe it when she said 'Yes I do.' And then he started talking about paroxetine and suggesting that she try it."

"Off-label" Prescriptions

Paroxetine - better known as Paxil in the U.S. - is an antidepressant. It is licensed only for adults, but doctors are allowed to prescribe any medicine if they think it will help their patient, a practice called "off-label" prescribing. Sharise was not the only teenager getting paroxetine off-label. Around 7,000 children a year were on the drug in the UK; and many more in the U.S.

Within days of starting on paroxetine, Stephanie noticed a dramatic change in her daughter: she became more confident. But with the confidence came aggression and worse:

"One day in the kitchen her sleeve pulled up slightly and I noticed that there were cut marks on her left arm. I couldn't believe my eyes. She was obviously self-harming while she was on the drug, something she's never ever done before."

Stephanie persuaded her daughter to stop taking paroxetine. But in 2003 Sharise went back on it without telling her mother. When her parents returned from a weekend break, Stephanie immediately realized something was terribly wrong:

"I went upstairs before my husband came in, and the moment I got to the landing at the top and I turned round and looked, she was hanging from the loft hatch. I tried to revive her, but before I even started I realized I was too late."

Next to her daughter's suicide note lay a packet of paroxetine. Stephanie instinctively blamed the drug and now blames herself for letting her daughter take it. But she couldn't have known what the drug's manufacturer had known for years.

GlaxoSmithKline Experiments on Children

UK-based GlaxoSmithKline (GSK), the second largest drug company in the world, which recorded 2006 sales of over $45 billion, had begun a series of clinical trials in the mid-1990s to test whether paroxetine would work in depressed children. Paroxetine had already been hailed as a wonder drug in adults as a treatment for everything from depression and stress to anxiety and even shyness. By the new millennium 100 million paroxetine prescriptions had been written worldwide, bringing in $2 billion a year for GSK and placing the antidepressant a close second to Prozac in popularity.

With the adult market sewn up, the company sought new ways to make money from the drug, or "life cycle management," as the approach is known in the pharmaceutical industry. The U.S. Food and Drug Administration wanted to boost the number of medicines tested for children and had introduced an incentive that would give companies a six-month extension on their patent just for carrying out pediatric trials. For paroxetine alone that would be worth $1 billion. And if GSK could be the first company to prove its antidepressant was safe and effective for children, the rewards would be even higher, as paroxetine could become the market leader.

Hundreds of children were recruited from around the world to take part in three clinical trials. One group was given the drug, the other a placebo. They were randomized controlled trials (RCT) where neither the children nor their doctors knew whether they were taking the active drug or the placebo until the end of the study. This is widely accepted as the best way of working out whether a drug causes a particular effect: the gold standard in terms of evidence.

But the outcome of these the trials was not what GSK had been hoping for. Paroxetine proved no better than placebo. In the biggest trial, Study 329, which was conducted across several sites in the U.S., 11 of the 93 children who took paroxetine developed serious side-effects; seven had to be hospitalized. Significantly more had self-harmed or attempted suicide on the drug than on placebo.

The BBC (British Broadcasting Corporation) obtained confidential case reports from Study 329 which detail what happened to them:

"[13 days after starting paroxetine] the patient became very angry. He punched pictures, broke glass and sustained lacerations that required six sutures... he expressed hopelessness and possible suicide thoughts."

"The patient began exhibiting symptoms of disinhibition, grandiosity and expansive mood around week four [after eight weeks] the patient became agitated and said she would kill herself."

"[11 days after starting paroxetine] the patient was hospitalized for psychosis with auditory hallucinations and superficial cuts."

Yet this was a drug that was supposed to make children happier and reduce the risk of suicide.

The company knew it had a problem. In an internal memo to senior executives in 1998 the product director for paroxetine admitted:

"The results of the studies were disappointing. The possibility of obtaining a safety statement from this data was considered but rejected. Consultation of the marketing teams confirmed that this would be unacceptable commercially."

In other words, publishing the data in full would undermine the drug's safety profile and put profits at risk. It took five years for this information to reach the public domain and only then as a result of the BBC investigation. In the intervening years doctors continued to prescribe a drug to tens of thousands of vulnerable children, ignorant of the fact that it had not been shown to work and was harmful to some.

Lawsuits Reveal Questionable Paper Trail

This has been described by British psychiatrist Dr. David Healy as "the biggest medical scandal since thalidomide." Dr. Healy, rather than the regulatory authorities charged with monitoring the safety of medicines, was instrumental in uncovering the evidence at the heart of the scandal. It was a series of U.S. legal actions that led Dr. Healy, as an expert witness, and the legal team with whom he was working, deep into GSK's secret archives, where they found a series of damning internal documents.

What this paper trail reveals is how the company, with no hope of obtaining a children's license, devised a back-door method of marketing paroxetine for childhood depression. In came the spin-doctors to bury the inconvenient facts and spread the good news to doctors around the world that paroxetine was safe and effective for children.

Drug companies discovered long ago that doctors are much more likely to be persuaded by their peers than by the hard sell of sales reps. So GSK built a business relationship with several leading academics to write articles and speak at conferences, effectively selling paroxetine for the company. They are known in the trade as "Key Opinion Leaders."

Internal company documents reveal that Professor Martin Keller, Chair of Psychiatry at Brown University in the U.S., was one of the company's leading Key Opinion Leaders. He was named as the author of Study 329. But the documents cast doubt on whether he actually analyzed the data himself and wrote the final paper. In a memo, Professor Keller thanks a ghost writer for the initial preparation of the study manuscript - a ghost writer who works for a medical public relations company hired by GSK:

"You did a superb job with this. Thank you very much. It is excellent. Enclosed are some rather minor changes from me."

It is clear from the internal correspondence that the ghost writer was making some important decisions about how to present the data for publication. At one point a senior GSK executive comments that: "It seems incongruous that we state that paroxetine is safe yet report so many Serious Adverse Events."

GSK suggests to the public relations person that she make clear paroxetine may have caused all 11 of the serious side-effects. But the final article says: "Of the 11 patients, only headache (1 patient) was considered to be related to the treatment."

The paper never states clearly how many children became suicidal, nor does it explore whether the drug was to blame. Instead, it concludes that paroxetine is "generally well-tolerated and effective".

The next step in GSK's marketing plan was to get the study published. Doctors rely on medical journals to give them advice they can trust. The first journal GSK approached spotted flaws in the study and rejected it. So the company sent it to the premier children's mental health magazine, the Journal of the American Academy of Child and Adolescent Psychiatry. Its peer reviewers also spotted the flaws, as is clear from their confidential comments:

"Overall. Results do not clearly indicate efficacy, authors need to clearly note this."

"The relatively high rate of serious adverse effects was not addressed in the discussion."

"Given the high placebo response rate, are [these drugs] an acceptable first-line therapy for depressed teenagers?"

Nevertheless, the journal published the study. Who knows how many child and adolescent psychiatrists around the world were influenced by the article's misleading conclusion?

At the same time, another of GSK's PR people was saying in an internal memo:

"Originally we had planned to do extensive media relations surrounding this study until we actually viewed the results. Essentially the study did not really show paroxetine was effective in treating adolescent depression, which is not something we want to publicize."

Objective Medical Opinion?

When I first started looking at Study 329 for the BBC in 2002, I was confused about its findings. The published article's conclusions seemed at odds with the details of the study. I went to Philadelphia to interview one of the authors and came across another of GSK's Key Opinion Leaders - Dr. Neil Ryan, an eminent child psychiatrist at the University of Pittsburgh. He was speaking at an American Psychiatric Association symposium sponsored by GSK but I had no reason at that time to think he was anything other than independent.

Dr. Ryan told the audience that paroxetine was effective for children with depression. He didn't mention anything about the apparent high rate of psychiatric side-effects of paroxetine in Study 329. But the more I studied the data, the more convinced I became that paroxetine was causing serious problems for some kids who took it. When I returned to Britain, I pursued him by telephone but he refused to talk to me about it.

Fast forward four years, when the internal GSK documents revealed what had actually been going on behind the scenes. Dr. Ryan had been asking the company that sponsored his research how he should deal with my awkward questions, emailing all my correspondence to them. In one email he said:

"I'll call you again later today and you can advise on how might be best to handle this."

GSK denies that it promoted paroxetine for off-label use through Key Opinion Leaders or any other route, laying the responsibility firmly at the door of individual clinicians.

A statement issued by the company reads: "Any decision to prescribe a medicine outside its authorized indications, in the EU or the U.S., is made by a doctor on the basis of his/her clinical judgement and the interests of their patient."

But where do doctors get the information from that gives them the confidence to prescribe off-label? From medical journals and conferences.

It was the documents that in the end exposed the Key Opinion Leaders and the drug company. Without the U.S. legal action we would have been none the wiser. The drug is now effectively banned in the UK for use in under-18s and in the U.S. it carries a "black box" warning about the risk of suicidal behaviour.

This drug was GSK's golden egg for many years and a lucrative business was built around its promotion. So it is perhaps not surprising the company dismissed my investigation as media scaremongering. What is surprising, though, is how many doctors on both sides of the Atlantic who claim to practice evidence-based medicine still refuse to acknowledge the damage the drugs can do - even though the evidence comes from GSK's own RCTs and the company's internal correspondence clearly shows how they tried to cover it up.

Sales Affected by Warning Labels

Dr. Mike Shooter, former President of the Royal College of Psychiatrists and a child psychiatrist who used to prescribe paroxetine, says:

"I personally felt cheated and heaven only knows what the children, adolescents and their parents and their doctors on the other end of that felt. Very much the same. This has huge implications, right through medicine."

Professor Keller and Dr. Ryan seem unabashed by their role in the scandal. A few months ago Professor Keller co-authored another paper, on the impact of media reporting on prescribing. Rather than exploring how those conducting the trials overlooked the damage to children caused by the drug, he and his co-authors expressed concern that prescriptions of antidepressants to children have declined sharply in the U.S. since the addition of the black box warning - as if the increased risk of suicidal behaviour on the drugs wasn't something that should affect prescribing.

The FDA is now considering whether to remove the black box warning on paroxetine and other similar antidepressants because it is scaring doctors. In the UK, the regulatory authorities are investigating whether GSK acted fraudulently in its conduct over Study 329. Theoretically, criminal charges could be brought, but the medicine's regulator is fully-funded by the drugs industry, so don't hold your breath.

Meanwhile, Stephanie Gatchell and her husband have moved away from the home that holds so many awful memories, to start a new life in Ireland. They can't forgive GlaxoSmithKline for concealing what it knew about paroxetine:

"I can't understand how they could possibly be so devious, and all just because of profit. I think the decision-makers in that company should be brought to justice. They have a lot to explain."

*Shelley Jofre is a reporter with BBC TV's flagship current affairs program: Panorama. To learn more about Sharise Gatchell, see http://www.gevil.netopti.net/.

GlaxoSmithKline issued a statement in response to Shelley Jofre's investigation.

WATCH SHELLY JOFRE'S POWERFUL INVESTIGATION

Video 'Secret Emails' kicks in around the 2.50 mark.