A Song For Andrew Witty…

“Working Class Hero”

As soon as you’re born they make you feel small
By giving you no time instead of it all
‘Til the pain is so big you feel nothing at allA working class hero is something to be
A working class hero is something to be

They hurt you at home and they hit you at school
They hate you if you’re clever and they despise a fool
‘Til you’re so fucking crazy you can’t follow their rules

A working class hero is something to be
A working class hero is something to be

When they’ve tortured and scared you for 20 odd years
Then they expect you to pick a career
When you can’t really function, you’re so full of fear

A working class hero is something to be
A working class hero is something to be

Keep you doped with religion, and sex, and T.V.
And you think you’re so clever and classless and free
But you’re still fucking peasants as far as I can see

A working class hero is something to be
A working class hero is something to be

There’s room at the top they are telling you still
But first you must learn how to smile as you kill
If you want to be like the folks on the hill

A working class hero is something to be
A working class hero is something to be

If you want to be a hero well just follow me

What Is Evidence Based Medicine?

Interesting video which makes us question what exactly is ‘evidence based medicine’?

Ireland banned St Johns wort in 1999 (in a rather dubious manner) and  the state is now allowing an Irish pharmaceutical company to re-introduce it in a pill form (called ‘Pacifa’ – nice new Orwellian word there). Bear in mind that the anti-depressant market is worth around 70 million to the pharmaceutical industry in Ireland alone.

Seems to me that the pharmaceutical industry had a lot do with banning St Johns Wort in the first place. I have always thought that. (Brian Cowen was the minister over health at the time, that says it all really).

Amazing also considering I never heard of anyone going bat shit crazy on herbal remedies, or being suicidal or homicidal from them.

Can’t say the same about SSRI’s though.

Which brings me back to my original thought, what exactly is evidence based medicine?

It seems to me that evidence based medicine is merely just what pharmaceutical companies, doctors (and their economic/ideological interests) tell us it is.

But is there another evidence based medicine?

Perhaps with the advent of the internet- there is.

In regards to Seroxat, for example, there are tens of thousands of people’s experiences documented on the web. These experiences describe a very dangerous drug and they describe side effects in great detail- Is that the true evidence base? As opposed to the weak, easily manipulated, untrustworthy (short term) trials which are passed by the regulators to sell the drug?

Trials like Study 329?

…surely the real world evidence base (which we can correlate now from online sources) trumps these measly bogus trials?

Are we- the public- the real evidence base?


Meanwhile In A Parallel Universe …


Seroxay suicide


Carl Heneghan: 329 trial restoration highlights need to restore public trust in trials

24 Sep, 15 | by BMJ

carl_heneghanFourteen years after a drug trial had been published, investigators —using multiple sources, including regulatory and legal documents—restored a version of the same trial and came to completely opposite conclusions.

The original study of 275 adolescents with depression—Study 329—concluded “paroxetine is generally well tolerated and effective for major depression in adolescents.” Yet the 2015 reanalysis in The BMJ, under the restoring invisible and abandoned trials (RIAT) initiative, is utterly at odds with this finding: “antidepressant trial finds popular drug ineffective and unsafe for adolescents.”

We know trial 329 widely influenced prescribing of paroxetine. Problems, however, emerged straightaway: the trial was largely ghostwritten, leading to the manipulation of data favouring the medication. Outcome definitions were changed—making an insignificant result significant—and children with suicidal thoughts or ideation were wrongly reported as emotionally labile or as hospitalised—downplaying the suicidal risks.

The problems of unreported and all too often misreported trials led to the RIAT initiative. This initiative calls for sponsors and investigators of abandoned studies to publish unreported trials or to republish those trials with concerns over their findings.

Using publicly available clinical study reports, other publicly available documents, and individual patient data, along with 77 000 pages of de-identified individual case report forms, the RIAT authors reconstructed the 329 trial. The original 329 trial publication reported 265 adverse events with paroxetine compared to the restored trial’s 481 events. Also, the original publication only reported 5 suicidal and self-injurious behaviours in the 93 participants on paroxetine; the RIAT paper—after detailed examination of the case report forms—reported 11 such events.

This reanalysis provides some insight into why GSK, in 2012, paid a fine of $3bn, part of which was for the unlawful promotion of paroxetine for patients under the age of 18. But it also questions the fundamental nature and basis of clinical research, the ethical principles underpinning research—including the impact conflicts of interest have on distorting the truth—and a journal publication process that, at times, allows inaccuracies to persist.

What is promptly needed to restore public trust is an overhaul of the current trial publication system. Journals should openly allow corrections and comments to be addressed: science should be self-correcting. Otherwise, we end up with a situation where an incorrect study, cited 576 times (oops, and 577 times if you are reading this), remains in the public domain, further reinforcing public suspicion over clinical trial results; making it more difficult to discern beneficial effects from harmful ones.

Carl Heneghan is professor of EBM at the University of Oxford, director of CEBM, and a GP.

His research interests span chronic diseases, diagnostics, use of new technologies, and investigative work with The BMJ on drugs and devices that you might stumble across in the media. He is also a founder of the alltrials.net campaign.

I declare that I have read and understood BMJ Policy on declaration of interests and I hereby declare the following interests: Carl Heneghan is a co founder of the AllTrials initiative and has an active interest in all studies being reported and published in full. CH has also been a co-recipient of a WHO grant on barriers to effective publication in public health emergencies and received a UK NIHR research grant for the update and amalgamation of two Cochrane reviews using unpublished data. He has received expenses and payments for his media work and for his teaching.

Video: More Harm than Good Conference on Psychiatric Drugs


On September 18th, the one day “More Harm than Good Conference” brought together many of the leaders of the critical psychiatry movement.  While the event has passed, the video and slides from the conference have been made available on the council for evidence-based psychiatry website.

The slides from the event can be downloaded here.


The More Harm Than Good Conference has now published individual videos of each to the talks given at the recent conference.

These can be accessed on their YouTube channel at: https://www.youtube.com/channel/UC8eIK8kuf7tht1gV1HApH0g.

The individual talks are:

Dr James Davies: The Origins of the DSM


Robert Whitaker: Our Psychiatric Drug Epidemic


Robert Whitaker: ADHD, Changing the Child Instead of the Environment


Prof Peter Gøtzsche: Why Few Patients Benefit and Many are Harmed


Prof John Abraham: The Misadventures of Pharmaceutical Regulation


Dr Malcolm Kendrick On Seroxat : Where The Hell Is The Outrage?

Study 329 – where the hell is the outrage?

To quote from the BMJ ‘No correction, no retraction, no apology, no comment…’

Study 329 was started in 1994 by Smith Kline Beecham, which shortly become part of the larger conglomerate Glaxo Smith Kline (GSK). Study 329 looked at the use of paroxetine, an anti-depressant, in adolescents with depression.

Following this study paroxetine was promoted and marketed heavily by GSK as demonstrating, in the words of GKS marketing materials: ‘REMARKABLE Efficacy and safety’. Over two million prescriptions were then written for children and adolescents in the US.

However, in 2002 the FDA considered study 329 to be a ‘failed trial.’ In 2003 the UK recommended that paroxetine should not be used in children and adolescents with depression because it increased the risk of self-harm and potentially suicidal behaviour.

In 2004 the FDA placed a black box warning on all antidepressants in adolescents and children stating that they increased the risk of suicidal thinking and suicidal behaviour in these groups. In 2102 GSK finally agreed to pay £2Bn for fraudulently promoting paroxetine.

But the story does not end here. A group of researchers, who had been heavily critical of this trial, finally managed to get hold of the raw data and carried out a re-analysis under the restoring invisible and abandoned trials (RIAT) initiative. Yes, this saga has been a long one.

The reanalysis was recently published in the BMJ with sadly predictable results. The primary conclusion was that ‘Neither paroxetine nor high dose imipramine showed efficacy for major depression in adolescents, and there was increase in harms in both groups.’

This is in stark contrast to the original trial results. When it was first published it appeared to demonstrate very clearly that paroxetine was both safe and effective in adolescents with depression. According to GSK it demonstrated ‘.remarkable efficacy and safety’ However, using exactly the same trial data, reanalysed by independent researchers, we now find that paroxetine was both useless and damaging.

So, what has been the consequences for those involved in the initial trial and the writing up thereof? For those who read the BMJ, you will know that I am now quoting verbatim here:

  • Despite subsequent FDA and MHRA warning about increased risks of suicidal thinking and behaviour and GSK receiving a record fine, partly for illegal off-label promotion of the drug, the original report has not been retracted or even had a correction
  • Academic and professional institutions have failed to publically address the many allegations of wrongdoing
  • None of the named authors had intervened to correct the record. An internal enquiry by the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP) concluded that no further action was necessary
  • Brown University remains silent over its involvement in the study. It refuses even to confirm or deny whether any investigation took place1

I will add to this that a co-author of study 329, Karen Wagner, named eight times in the 2011 US Department of Justice complaint against GSK, is currently the president elect of the American Academy of Child and Adolescent Psychiatry – whose journal, the JAACAP, is where the original study was published.

Taking stock. What do we have? A study was done, and published, demonstrating that paroxetine was safe and effective. The trial data were heavily promoted, resulting in millions of children and adolescents being prescribed paroxetine.

The reality is that this drug was completely ineffective and increased the risk of suicide (amongst other things). This has all been known for many years. The latest re-analysis simply confirms everyone’s worst fears.

So surely someone, somewhere, got punished? No they did not. Not only that, but the original published study has not even been retracted. It still sits in the medical database. A young and innocent researcher could come across it, and reference it, and use data from it to support a grant application for a study to use antidepressants in children.

If this were not all completely and absolutely one hundred per-cent fact, you might think we have a possible plot line for a dystopian novel here. A story of terrible corruption where large corporations can distort data through one hundred and eighty degrees, and get away with a fine. A world where bent researchers promote research that results in more children committing suicide, and then move on positions of greater power and authority – with no censure from anyone. To become presidents of major medical societies, for example.

Frankly I don’t think I would dare to write a novel with a plot so completely outrageous. Surely someone, somewhere, would be punished for this behaviour. Surely the paper would be retracted. Surely a co-author of such a study would not be in line for a prestigious position. Surely the public would rise up in outrage.

In truth, it seems, nothing is going to happen at all. I must dig out 1984 and read it again, just to depress myself even further.

1: BMJ 2015;351:h4629

Landlord killer had been advised to stop taking medication

Anti-psychotics are absolutely lethal..

I have no idea how the psychiatrist got away with this but it seems like typical psychiatric negligence to me..

Olanzapine is brand name Zyprexa, I have seen first hand the effects of this drug in a friend. The side effects are really scary.

Landlord killer had been advised to stop taking medication

Two days after coming off medicine Saverio Bellante fatally attacked Tom O’Gorman

Saverio Bellante: Diagnosed with religious hysterical deliria in 2005.Saverio Bellante: Diagnosed with religious hysterical deliria in 2005.

Fri, Jul 31, 2015, 01:00

A man with a history of mental illness killed his landlord and consumed part of his body two days after he came off his medication under the direction of a psychiatrist in Dublin.

The Central Criminal Court has been told the medical professionals treating Saverio Bellante (36) in his native Italy believed he should remain on the medication for life.

After the dose of his anti-psychotic medication Olanzapine had been gradually lowered when he came to live in Ireland, the medication was stopped on the advice of a consultant psychiatrist on January 9th, 2014.

Two days later he became embroiled in a dispute with his landlord Tom O’Gorman during a game of chess.

Fatally attacked

Mr Bellante fatally attacked the freelance journalist at Mr O’Gorman’s home on Beech Park Avenue, Castleknock, Dublin 15, where he lived as a lodger.

He struck him with a dumb-bell on the head and stabbed him in the head, chest and neck. The accused then cut open the victim’s chest and removed his right lung, which was found in a plastic bag in the kitchen. He believed he had removed the dead man’s heart to eat it “as it was the way to good and evil”.

Mr Bellante was diagnosed with religious hysterical deliria in 2005. He is charged with murdering Mr O’Gorman at an unknown time between January 11th, 2014 and January 12th, 2014 at the Castleknock address. A verdict of not guilty by reason of insanity is open to the jury.

What Did They Prescribe Cathriona White?


It will be interesting to see what medication Cathriona White was prescribed..

Coroner Releases New Information About Jim Carrey’s Ex’s Death

Coroner Releases New Information About Jim Carrey's Ex's Death

New details have emerged in the death of Jim Carrey’s ex-girlfriend Cathriona White.

Friends found White dead in her Sherman Oaks home on Monday.

Assistant Chief Coroner Ed Winter told Us Weekly that there were pills next to the makeup artist’s body, and confirmed that a suicide note at the scene mentions Jim Carrey.

The Coroner’s Office has not yet named the type of medication found at the scene, nor whether the suicide note was addressed to Carrey.

The autopsy is not complete, and toxicology results could take up to ten weeks.

According to People, White’s mother, stepmother and sister are traveling from Ireland to L.A. to claim Cathriona’s body.

Jim Carey’s Irish Girlfriend, Cathriona White, In Suspected Suicide (Pills Found At Scene)

Carrey said he used antidepressants to manage his depression, but now relies on natural supplements. “I think Prozac and things like that are very valuable to people for short periods of time,” said Jim. “But I believe if you’re on them for an extended period of time, you never get to the problem.”


Although White’s official cause of death cannot be determined until an autopsy is conducted, Winter said there were indications at the scene of a suicide.

“It was reported as a possible suicide. There evidently was a note found. There were pills located near her,” said the spokesman, who added that the “final cause of death won’t be released until we get full toxicology and tests back.”

According to the Irish Independent, White – a native of the Tipperary region of Ireland – and Carrey, 53, first met on a film set in 2012. They reportedly dated for most of 2013 before reuniting earlier this year.


Paxil Harms Teens : So Who Is Responsible? Who Should Be Held Accountable?

Well clearly the American Academy of Child and Adolescent Psychiatry and the Journal of the American Academy of Child and Adolescent Psychiatry don’t think they have anything to feel bad about…


aacap and jaacap respond…

Posted on Saturday 26 September 2015

[The following emails from the American Academy of Child and Adolescent Psychiatry and the Journal of the American Academy of Child and Adolescent Psychiatry were forwarded to me by members]

Dear Members,

This week, The BMJ published a study, “Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence,” which reanalyzes data from a clinical trial performed in the late 1990s and published in JAACAP in 2001. The conclusions of this article contradict those of the original study. Please know that the Academy has been fully aware of the pending publication of this article by The BMJ.

Research provides the foundation for child and adolescent psychiatry’s knowledge base. The Academy encourages rigorous scientific design and methodology and supports the highest ethical and professional standards. We also believe it is essential that research be conducted within a strong framework of transparency and disclosure. As an organization, AACAP has been a leader in advocating for the positive changes that have taken place in the last decade in the relationship between the pharmaceutical industry and academic and professional associations.

As the leading national professional medical association dedicated to promoting the healthy development of children, adolescents, and families, through advocacy, education, and research, our response to The BMJ publication is as follows:

  • AACAP has the utmost respect for the The BMJ and we thank them for their continued efforts to further scientific knowledge and understanding.
  • AACAP supports transparency in clinical trial reporting and welcomes the RIAT initiative, which enables publicly available primary data to be reanalyzed and published as new, potentially revised reports.
  • JAACAP is a forum for scientific reporting and scholarly discussion. The scientific process builds on itself over time through a cycle of new research, analysis, and ongoing dialog. This process stimulates debate and moves the field forward toward a better understanding of critical issues.
  • As with most medical journals, JAACAP operates with full editorial independence. AACAP does not influence or direct decisions regarding specific publications. Furthermore, the statements and opinions expressed in JAACAP articles are those of the authors, and not necessarily those of AACAP, the editors, or the publisher. Inquiries about the articles and study in question should be addressed to their respective authors.

Moving forward, we will continue to monitor any developments and keep the membership informed of relevant information as it becomes available. Please direct any questions to the Communications Department via email at communications@aacap.org.

Thank you for your continued support!
Paramjit T. Joshi, MD
President, AACAP

The American Academy of Child and Adolescent Psychiatry

3615 Wisconsin Avenue, N.W. | Washington, D.C.20016-3007 | Phone: 202.966.7300 | Fax: 202.966.2891


Dear __________,

As many of you are already aware, The BMJ recently published a reanalysis1 of clinical trial data (study 329) that is inconsistent with the results of a study originally published in JAACAP in 2001.2

This reanalysis does not come as a surprise. Under the Restoring Invisible and Abandoned Trials (RIAT) initiative, originally proposed in 2013,3 research groups are encouraged to use publicly available data to publish new, potentially revised reports of past clinical trials, and we had anticipated that study 329 would be among the first to be revisited.

Since I became editor-in-chief in 2008, nearly seven years after the original article’s publication, we have received a number of inquiries about study 329. JAACAP takes seriously its responsibility to ensure scientific integrity, and manages allegations of scientific misconduct and breaches of publication ethics according to guidelines set forth by the Committee on Publication Ethics (COPE).4 JAACAP’s editorial team has reviewed allegations against study 329 several times over, and after thorough assessment, found no basis for editorial action regarding the 2001 article.

JAACAP represents a collaborative effort designed to disseminate research findings and facilitate discussion within our community. The scientific process is one of continual evolution – a cycle that advances with each new replication, refinement, or rejection of past findings. Under the vast umbrella of scientific research and reporting, we must always make room for opposing views and varying interpretations. There can be no final word on any subject, but our common goal must be the same: to advance the science of pediatric mental health and to promote the care of youth and their families.

Andrés Martin, MD, MPH

1 Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. BMJ. 2015;351:h4320.
2 Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial. J Am Acad Child Adolesc Psychiatry. 2001;40:762-772.
3 Restoring invisible and abandoned trials: a call for people to publish the findings. BMJ. 2013;346:f2865.
4 Committee on Publication Ethics Guidelines.

The American Academy of Child and Adolescent Psychiatry

3615 Wisconsin Avenue, N.W. | Washington, D.C.20016-3007 | Phone: 202.966.7300 | Fax: 202.966.2891


Andrew Witty… What Do You Have To Say About Paxil (Seroxat) Harming Kids (And Adults)?

“Paxil shouldn’t be prescribed to anyone under 25, and probably not at all,” he says. (Dr. Jon Jureidini)

I was prescribed Seroxat at 21 and I lost nearly 4 years on the drug and more after that trying to recover, I won’t get my twenties back Andrew Witty, what the hell are you going to do about it? Don’t you think you should apologize on behalf of the company which has made you a millionaire off the backs of my suffering and countless others? How the hell do you sleep at night?


New Paxil Warnings For Teens Prompt Fury From Former Patients

By @amynordrum a.nordrum@ibtimes.com on September 29 2015 12:16 PM EDT
The antidepressant Paxil is not as safe and effective in teens as the drug’s manufacturer has claimed, according to the authors of a new study who re-evaluated original data from clinical trials. REUTERS/Joe Raedle

Kaili Butin still has faint scars on her wrist from the day she tried to kill herself. A family physician had prescribed GlaxoSmithKline’s antidepressant Paxil to treat her depression. It was the fall of 2000, her sophomore year of high school, and she had stopped caring about schoolwork and lost interest in her friends.

“I wanted something to make me feel better,” she says. “I wanted to be a normal teenager. I saw my friends and none of them felt the way I felt.”

Butin was among millions of American teens who took Paxil in the early 2000s. Her doctor’s recommendation helped the antidepressant overtake the competition to garner the highest number of new prescriptions of any drug in its class in 2000. Sales of the pill increased by 17 percent to hit $2.4 billion. Butin, now a 31-year-old accountant living in Ankeny, Iowa, is angry about newly revealed information that GlaxoSmithKline withheld from the public regarding Paxil’s danger to teenagers.

Butin remembers feeling a change set in soon after she began taking the drug. She wrote furiously in journals to manage her emotional plunge.

“I just remember feeling worthless,” she says. “I had an entire journal of poems that I would write on how horrible life was and how it just wasn’t worth being around anymore and everybody would be better off without me.”

After a few weeks on Paxil, Butin began to experience “major rage.” She punched walls and lashed out at friends and family. Her poems became graphic. Eventually, she turned violent toward herself.

“I remember one day, just not even really realizing what I was doing but taking a pair of scissors to my wrists,” she says.

Kalli Kaili Butin, 31, took the antidepressant Paxil as a teenager. She says she experienced anger issues and attempted suicide multiple times while on the drug.  Kaili Butin

When she yelled out in alarm, her mother rushed in and stopped her. After the suicide attempt, Butin says she and her mother thought they needed to give the medicine more time to work. But several months later, Butin felt worse than ever. One night at bedtime, she found herself staring at the eight or nine pills left in the bottle.

“I downed all those and I downed some Tylenol and I remember hoping I wasn’t going to wake up the next morning,” she says.

She did wake up — in the middle of the night, sick to her stomach. The next morning, she told her mother what she had done.

“She said, ‘That medicine’s obviously not working, and we need to figure something else out,’” Butin says.

Butin tried to kill herself twice in six months while on Paxil. She has never tried to harm herself at any other point before or after taking the medicine. More than a decade and a half later, new evidence suggests what Butin and her mother began to suspect that night — that Paxil may have worsened Butin’s depression to the point that she wanted to kill herself.

This month, a team of researchers published a new analysis of a 14-year-old clinical trial data that suggested adolescents who used Paxil were at greater risk of severe side effects — including suicidal thoughts and self-harm — than GlaxoSmithKline originally disclosed. While it’s impossible to know whether her suicide attempts were a direct result of taking Paxil, Butin says she is “very confident” that the drug is to blame.

Specifically, the analysis published in BMJ uncovered 11 cases of suicidal thoughts or self-harm among 275 young adults who took Paxil. GlaxoSmithKline had previously reported just five. Researchers also concluded the drug was no more effective at treating depression than a placebo — a startling revelation for a drug that has been on the market for two decades.

The new analysis — for which researchers perused 77,000 pages of previously unavailable internal records — sparked outrage among former patients and set off a tsunami of criticism of GlaxoSmithKline.

Paxil has been a lucrative treatment for GSK. Doctors wrote more than two million prescriptions for Paxil for teens and children in 2002; use of all antidepressants among young people jumped 36 percent the following year. By 2003, the pill was racking up $3 billion in global sales.

In light of the new findings, the company maintained the original analysis of clinical trial data for Paxil, also called paroxetine, is valid.

“Importantly, the findings from this team’s analysis appear to be in line with the longstanding view that there is an increased risk of suicidality in pediatric and adolescent patients given antidepressants like paroxetine,” the company said in a statement. “This is widely known and clear warnings have been in place on the product label for more than a decade. As such we don’t believe this reanalysis affects patient safety.”

Still, the complete GSK data on adolescents’ risk of suicide and self-harm became publicly known only decades after it was first available to the company. Critics say that delay illustrates the inherent problem with the longstanding tradition of permitting drug companies to sponsor clinical trials on the medications they hope to sell.

Now, Butin and others who took Paxil in their teen years are horrified that the scientific evidence to validate their experiences was so slow to emerge.

“The first thought I had was, no sh–, sherlock. I was like, seriously? They’re just now figuring this out?” she says. “I mean, what took so long?”

antidepressants by age-01 Just under 4 percent of adolescents took antidepressants in the late 2000s, compared with about 10 percent of people in the general population.  Hannah Sender

Within the scientific and medical community, the study was heralded as one of the first cases in which independent reviewers were permitted to comb through clinical trial data. In most cases, such data is carefully guarded by drug companies and reviewed only by the FDA.

GSK voluntarily published the Paxil trials through a new program called RIAT, which stands for Restoring Invisible and Abandoned Trials. RIAT aims to nudge clinical research and drug development toward greater transparency and data sharing, and GSK was the first company to participate.

But before the trials were posted, anyone who took Paxil in their teenage years did not have all the information about the drug’s risks available to them. Those who took it before the warning label was required — including Butin — had even less of a clue. She cannot recall her doctor talking to her about the potential side effects of Paxil.

Feeling Hopeless

“I started feeling very isolated, I started feeling like nobody loved or cared about me,” she says. “I didn’t want to go

Breena Vickers, 31, of Dunedin, Florida, says she feels strongly that Paxil put her in a dangerous state of mind when she took the drug as a 15 year old. Just days after she swallowed the first pill, her mood plummeted and “things started getting really bad.”

to school because I was like — what’s the point? I lost hope for the future, basically.”

Vickers’ mother told her to stick with the medicine because she believed it would ultimately help. But two and a half weeks after starting Paxil, Vickers could no longer see the point of living. So she decided to stop.

“I tried to cut my wrists and my father literally wrestled a straight razor out of my hands,” she says.

Breena Breena Vickers (right) is 15 years old in this photo, which was taken shortly after she stopped using the antidepressant Paxil.  Breena Vickers

Just a week later, Vickers reached into her mother’s medicine cabinet for a bottle of Vicodin and swallowed all the pills at once. She became violently ill and fell into a deep sleep.

When she woke up, she thought about what had changed in the past few weeks and decided to stop taking Paxil.

“It clicked in my head — I’m trying to kill myself,” she says. “I’m trying to end my life and this is not what normal people do.”

About three days after she stopped treatment, she began to feel better. She sought out her friends and became interested in school again. She hasn’t taken Paxil or any other antidepressant since, and instead sought behavioral therapy until she was 17 to cope with her depression.

Vickers attempted suicide twice in just four weeks while on Paxil. Similar to Butin, she did not try to end her life at any point before or after treatment.

Too Little, Too Late?

Paxil is a selective serotonin reuptake inhibitor (SSRI), a class of drugs that includes Prozac and Zoloft. SSRIs have been shown to elevate mood by preventing the brain from re-absorbing a neurotransmitter called serotonin.

Antidepressants often demonstrate low efficacy in clinical trials. In reality, some patients may respond very well even if the vast majority does not respond at all. It’s common practice for doctors to cycle through antidepressants to see which one elicits the best response in each patient.

Psychiatrists who prescribe antidepressants to adolescents know that Paxil carries some of the most dramatic side effects among SSRIs. For that reason, doctors have exercised extreme caution in offering the drug to teens or phased out its use in adolescents entirely.

“We know it can work for some people but it certainly does have a lot of warts in terms of side effects and tolerability concerns,” Dr. Jerry Halverson, a psychiatrist and medical director at Rogers Memorial Hospital in Oconomowoc, Wisconsin, says. 

In 2003, the Food and Drug Administration recommended Paxil not be given to teens at all. In 2004, the agency required GSK to feature a prominent warning label regarding the drug’s use in adolescents. In 2012, the U.S. Department of Justice required GSK to pay nearly $3 billion partly for inappropriately marketing the medication as effective and safe for teens.

The company has also settled multiple class action lawsuits in which plaintiffs argued that Paxil was dangerous and ineffective for adolescents and children, including a $63.8 million agreement with the consumer watchdog group called Public Citizen in 2007.

GSK GlaxoSmithKline, the maker of Paxil, is headquartered in Hounslow, U.K.  REUTERS/Luke MacGregor

Amanda Scott, a 31-year-old woman who lives in Pennsylvania, says she never would have begun taking Paxil at the age of 13 if she knew what she knows now. She initially felt a boost in her mood after taking the pills in 1997. But after a year, that feeling wore off. She told her psychologist that she was considering suicide.

“I had a plan which is something I never had before,” she says. 

After that disclosure, Scott was hospitalized for five days. When she was discharged, her doctors increased her dosage of Paxil. She remained on the medicine for another year. During that time, she thought about killing herself every day and would cut at her arms about once a month. 

Though she tried to kill herself on nine different occasions between the ages of 13 and 19, she recalls a “cluster” of attempts during the period when she took Paxil, including overdosing on aspirin. 

She told her psychologist and psychiatrist about every attempt, but does not recall ever discussing a potential connection to Paxil or the many other antidepressants that she would cycle through in later years.

“I wanted help, I didn’t want to feel like this,” she says. “We never suspected that it was the drugs that were the problem and the response was always to give me different drugs.” 

But when Scott read about the new study, she felt she finally had an answer.

“It made sense to me because I knew what I went through,” she says. “I think it started me on a very bad track that pretty much just took my entire teenage years away.”
A Serious Message

Dr. Jon Jureidini, a research psychiatrist at the University of Adelaide in Australia and the lead author of the new analysis, urges psychiatrists to take the results of the new analysis seriously.

“Paxil shouldn’t be prescribed to anyone under 25, and probably not at all,” he says.

Meanwhile Dr. Martin Keller, a retired psychiatrist at Brown University who led the original research, echoes the company’s sentiment.

“We see nothing in the reanalysis in the BMJ article that would change the treatment of adolescent depression for a contemporary clinician using evidence-based treatment,” he says

Dr. Greg Simon, chair of the Depression and Bipolar Support Alliance’s Scientific Advisory Board, calls for a more focused effort on such research questions as: How can we find depression treatments that have better average effectiveness? How can we better match individuals to the right treatment?

Vickers was sitting on her couch at home when news of the Paxil study popped up in her Facebook news feed. She could instantly recognize the study’s significance, even if today’s psychiatrists feel like its results are underwhelming.

“I was like — oh, oh really, they’re just now finding this out!? I could have told them that 10 years ago!” she says. “I was outraged.”

AllTrials Is A Red Herring… We Need Access To ALL DATA…

For the red herrings see here

Sir Iain Chalmers, coordinator of the James Lind Initiative and co-founder of AllTrials:

“Among pharmaceutical companies, GSK under its current management has led the way in promoting clinical trial transparency and provides a practical mechanism to make trial re-analyses possible. The reanalysis of Study 329 illustrates the knowledge dividends from the company’s new policies and contrasts strikingly with the scientific misconduct that characterised the company’s behaviour under previous management. Today’s GSK has shown moral and scientific leadership that puts to shame many in the academic community.

Erm no Ian, today’s GSK  (2014) were recently caught bribing hundreds of Chinese doctors and fined 500 Million dollars last year.  You fail to mention this very recent moral indiscretion.

GlaxoSmithKline Found Guilty of Bribery in China

U.K. Drug Maker Handed Largest Ever Corporate Fine in China

This fine was hardly a sign of moral leadership Ian, so don’t be ridiculous..

In regards to GSK’s scientific leadership, while giving the access to data for study 329 is undoubtedly a good thing, the fact that GSK hid it for so long (and promoted Paxil/Seroxat off label to doctors/kids which resulted in kids killing themselves) is not. I am shocked that you would try to spin this as somehow good PR for GSK . Study 329 was abhorrent, Seroxat is a disgrace.

Seriously, what planet are you on Ian?

Where is GSK’s apology for all this carnage?

Publicity from Study 329 contributed to paroxetine being prescribed to “hundreds of thousands” of adolescents, Jureidini said.

Dr David Healy’s  new post, ‘Data Wars‘, raises some very important points in regards to the ‘data transparency debate’.

I have long been suspicious of Alltrials, Ben Goldacre, Simon Wessely, Sense About Science and the various other ‘movers, shakers and consensus makers’ in this debate, and I’ve written several posts about them explaining why:

See these posts of mine for further details-



Call me suspicious by nature, and perhaps I am, however when you’ve been writing, and researching, about GSK’s various unethical shenanigans (for almost 9 years now) you tend to sense when something isn’t quite right. Couple that with a horrendous time on Seroxat, then finding out afterwards that it all could have been prevented if the whole psych/pharma system wasn’t so corrupt, and throw in my sheer determination -for over a decade now- to expose every corner of the Seroxat Scandal, and you end up down some very strange rabbit holes indeed.

The recent expose (restoration of Seroxat Study 329) by the RIAT team, published in the BMJ, caused quite a stir online. Not only did it make headline news, but the responses on social media could warrant many studies in themselves. Paxil/Seroxat harmed many people. These are not ‘anecdotes’, these are people’s lives-

See these posts for details of the impact of Paroxetine world-wide:



The real world affects of Seroxat (Paroxetine/Aropax/Paxil) have been horrendous for those who were unfortunate enough to have been prescribed it. I’ve known that Seroxat is a dangerous drug since I was first prescribed it in 1998. It was only after I came off it, in late 2001 or thereabouts, that I discovered (courtesy of the BBC through their Panorama programme- “The Secrets of Seroxat‘ documentary) that the problems with Seroxat (of increases in suicide, self harm, akathisia, murder, aggression, withdrawal, dependence etc) were worldwide problems. There was some solace in finding this out from the BBC Seroxat series, however I won’t get those lost Seroxat years back. I won’t get my health back that I lost either, nonetheless an apology from GSK for almost killing me with their drug, lying in PIL’s, and corrupting doctors, would be nice though- but I won’t hold my breath. I was collateral damage, and harm to people like me is factored into GSK’s cost of doing business. To GSK, my life was disposable, so it’s insulting for me when I see people like Ben Goldacre and Sense About Science collude with sociopathic companies like GSK.

I find this extremely disturbing.

Alltrials is a redherring, so is Ben Goldacre’s  transparency agenda. Simon Wessely is too, as are Sense About Science.

I don’t trust any of these people/organizations. I don’t believe patients should either.

Why do I say that?

Well, hundred thousands of kids were likely put at risk from GSK’s promotion of their dangerous Seroxat/Paxil drug off label. Many high profile psychiatrists put their names to the ghost written study 329 and subsequently- the lives of hundreds of thousands of kids were put at unnecessary risk. They were prescribed a drug (Seroxat/Paxil) which has been shown to be harmful. Many died and many were damaged, plus we haven’t even begun to assess the damage to the adults who were prescribed Seroxat.

I was one of those adults. I am one of those people who suffered. What is going to be done?

Where is the outcry about Seroxat killing kids from people like Prof Simon Wessely? (the head of the UK college of Psychiatry).

Where is the utter condemnation from people Dr Ben Goldacre? (A supposed patient advocate).

Where is the press release from Sense About Science castigating GSK for this disgraceful crime?

Where are their statements expressing their utter disgust at this flagrant abuse of vulnerable people? (Depressed people prescribed Seroxat).

They’re simply not there… none of these people/organizations have condemned this scandal.

Instead what we have are organizations like Alltrials basically congratulating GSK (for giving access to a study which was fraudulent in the first place) and helping GSK spin this abhorrent Seroxat study 329 scandal into something positive (quite how they can justify this is beyond me). Notice how Alltrials fail to condemn GSK for putting kids at risk, but how they try to spin this as GSK somehow being the good guys for providing the patient level data to David Healy and the RIAT team.

What Alltrials also fail to draw attention to is- the fact that the process itself was close to impossible (it also took years), and it was through sheer determination and tenacity on behalf of the RIAT team that they got to study the data never mind teh pain staking process of attempting to analyze it. Furthermore, what Alltrials also don’t mention is- the RIAT process and Rxisk are looking for the Data – Access to all the data, not just the registering of trials. What use are the trial results and what use are the trials themselves without the data which makes them? We need access to all the data. Alltrials isn’t looking for this- that’s why I don’t trust them.

Alltrials is a red herring, so are Sense About Science-  and along with the true extent of Seroxat harming kids (and adults) that’s what the RIAT team has also just exposed…

See David Healy’s Data Wars for more:


Sense about Science

Simon Wessely and Clare Gerrada are the power couple of British Medicine.  He is the current President of the Royal College of Psychiatrists, and she is a recent President of the College of General Practitioners.  When faced with questions about over-prescribing of antidepressants by GPs, she is quick to insist that GPs rarely treat distress and that almost all prescribing is for genuine illness and the drugs work well.  He gives similar messages in respect of psychiatry.

Sense about Science began in Britain 15 years ago with donations from Corporations in the Risk Management Business – from Monsanto through Nuclear Power to Pharma. These donations have vanished from sight now, replaced by endorsements from all major UK universities and journals like The BMJ and support from Charitable Foundations.

SAS’s stated mission would have appealed to someone like SW who had come under attack from a lot of fringe groups in the 1990s for taking a balanced data-driven approach to Chronic Fatigue Syndrome (M.E.).

But SAS has now become a node to handle any messages in the media that might hurt the interests of a company or corporate sector – such as anything to do with vaccination or my recent editorial on So Long and Thanks for all the Serotonin.  BMJ sent this article (as they send all articles) to SAS who got in touch with SW to rustle up statements from Jeff Lieberman types which can be disseminated widely to the media either for citing or as a means to close down stories:

You might not want to take Healy’s work seriously in the light of what these senior figures in the field are saying.

Sense about Science has since spread to Canada, Australia and now the United States and everywhere the mission is the same.

AllTrials & AllData

SAS was a founder of AllTrials.  This sounds like AllData – the hashtag for Restoring Study 329 – but at the moment it is quite the opposite.

There has been close to radio silence from AllTrials in the face of the call for AllData, aside from one stunning press release that more or less credits GSK with the efforts to Restore Study 329.

17th September 2015

Many supporters of AllTrials will be interested in a study published in The BMJ today, a reanalysis of previously hidden clinical trial data. The new research used data from a 1990s clinical trial of the GlaxoSmithKline (GSK) antidepressant drug paroxetine. Today’s findings contradict a 14-year-old analysis of the data referred to as Study 329, which found paroxetine to be safe and effective for treating adolescents with major depression.

The new research is the first reanalysis of a drug study under the RIAT (Restoring Invisible and Abandoned Trials) initiative, which calls on companies and academic funders to publish detailed trial information for independent scrutiny. The RIAT team was able to access the original clinical trial data using GSK’s patient-level data access portal, where researchers can request access to this information.

Tracey Brown, Director, Sense About Science and co-founder of AllTrials:

“When all trials are registered and results reported, it becomes possible for researchers to work out what data are available. GSK has gone further and made its patient level data available to researchers. It is disappointing that there are still so many companies not reporting trials. Researchers, doctors, patients and, in July, their shareholders have said they want transparency about trial results. This will confirm their views.”

Sir Iain Chalmers, coordinator of the James Lind Initiative and co-founder of AllTrials:

“Among pharmaceutical companies, GSK under its current management has led the way in promoting clinical trial transparency and provides a practical mechanism to make trial re-analyses possible. The reanalysis of Study 329 illustrates the knowledge dividends from the company’s new policies and contrasts strikingly with the scientific misconduct that characterised the company’s behaviour under previous management. Today’s GSK has shown moral and scientific leadership that puts to shame many in the academic community.”

Pontius Andrew?

Faced in 2012 with questions about the $3 Billion fine imposed on GSK, triggered by a sequence of events starting with Study 329 – is it just the cost of doing business? – Andrew Witty snapped back:

“Although corporate malfeasance cases end up looking very big, they often have their origin in just… one or two people who didn’t quite do the right thing. It’s not about the big piece. The 100,000 people who work for GSK are just like you, right? I’m sure everybody who reads the BMJ has friends who work for drug companies. They’re normal people… Many of them are doctors”.

Everything about Study 329 suggests that Andrew is comprehensively wrong. Corporate malfeasance happens when the system is set up so that the efforts of 100,000 well-meaning people get transformed into the worst of outcomes and it then takes the efforts of a few brave people within GSK to alert the outside world to how things are going wrong.