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.”

http://www.examiner.com/article/jim-carrey-s-girlfriend-commits-suicide-drug-overdose-days-after-breakup

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.

http://www.people.com/article/jim-carrey-girlfriend-cathriona-white-commits-suicide-report

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…


http://1boringoldman.com/index.php/2015/09/26/aacap-and-jaacap-respond/

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]

09/16/2015
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

www.aacap.org

09/25/2015
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.

Sincerely,
Andrés Martin, MD, MPH
Editor-in-Chief


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

www.aacap.org

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?

http://www.ibtimes.com/new-paxil-warnings-teens-prompt-fury-former-patients-2108017

New Paxil Warnings For Teens Prompt Fury From Former Patients

By @amynordrum a.nordrum@ibtimes.com on September 29 2015 12:16 PM EDT
Paxil
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-

https://truthman30.wordpress.com/2014/08/15/whats-the-real-story-simon-wessely/

https://truthman30.wordpress.com/2013/11/19/ben-goldacre-bad-pharma/

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:

https://truthman30.wordpress.com/2015/09/22/i-knew-that-shit-was-poison-12-people-describe-their-young-lives-on-paxil-seroxataropax/

https://truthman30.wordpress.com/2015/09/19/social-media-discusses-paxil-seroxat/

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 the 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:

http://davidhealy.org/study-329-data-wars/

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.


GSK 2 GSK1

Shocking Side Effects Of GSK’s Zyloric ! : How GSK drug turned a healthy banker into a monster


http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm303182.htm

ADVERSE REACTIONS
Postmarketing Reports
Voluntary reports of adverse events in patients taking Paxil that have been received since market introduction…

Stevens-Johnson syndrome (added)

This horrible side effect from GSK’s Zyloric drug reminded me of when I was in Seroxat withdrawal and the skin peeled off my feet. I’m sure it was from Seroxat because it literally felt like Seroxat was so toxic that it was coming out in my skin. My feet blistered and the skin just all peeled off, and the coloring was similar to photos I have seen of this Stevens Johnson syndrome- I wasn’t as bad as this case and I’m not sure if it was definitely Stevens Johnson Syndrome,  but It was very scary. I hope that the poor guy has recovered…

zyloric300mgTabs

How GSK drug turned a healthy banker into a monster

GSK

Health and Living
How GSK drug turned a healthy banker into a monster
By admin –
Sep 11, 2015

http://insidemainland.com/how-gsk-drug-turned-a-healthy-banker-into-a-monster/

With the help of Joseph Edgar – a popular blogger and investment banker- InsideMainland was able to get this very surreal tale of a banker, Charles Oben, whose life took a dramatically destructive turn in the course of seeking a healthy life.

It started when Charles who worked with the UBA was posted to Burkina Faso and in his usual meticulous self visited a Cardiologist for a routine check. They found out that his urea level was high and the drug Zyloric (manufactured by Glaxo Smithkline (GSK) Pharmaceuticals) was prescribed. He bought the drug for about N1,300 and dutifully took administered dosage. However in less than 36 hours his life was turned into a living hell.

Blisters, skin peeling, eyes destroyed, bleeding from everywhere, bed sores and everything imaginable became his plight. His wife Joan flew in, saw her husband and melted. His children came in and ran away. Mirrors where kept away from him.

Charles condition is known as the Stephen Johnson Syndrome (SJS) typically caused by a severe allergic reaction to a medication. SJS usually begins with a Stevens Johnson Syndrome rash that can lead to blistering, severe peeling and open sores. The condition is a serious and potentially life-threatening disease (Read more about SJS)

Charles was eventually evacuated to the UK with the private efforts of Joan and his family and there he received succor but with lasting side effects. He has had two cornea replacement surgeries and much more devastating is the fact that he cannot shed a tear for the rest of his natural life. He has been confined to the use of artificial tear inducing drugs which he buys from America at the cost of $200 monthly.

He has dragged Glaxo Smithkline the manufacturer of the drug to court for the irreparable damages to his life.

Joan, Charles’ dedicated wife wants the Nigerian government to push the pharmaceutical companies in the country to take proactive steps in warning consumers not only about the side effect of their drugs, but also about the severity that such side effects may escalate.

She said, “drug companies will stop taking advantage of the populace. That legislation should force them to write the warnings in the right language and in the right context in the leaflet. If Zyloric, or any of its other commercial names can possibly lead to SJS, which can lead to blindness and death, it should say so on the drug and it should say so in the local language. English for Nigeria.”

charles GSK-2-300x225 GSK-4-300x225

http://www.vanguardngr.com/2011/09/only-redress-can-assuage-my-pains-victim-of-drug-reaction/


Only redress can assuage my pains – victim of drug reaction

on September 28, 2011   /   in Features 12:10 am   /   Comments

By Emmanuel Elebeke & Ifeanyi Okotie

ZYLORIC may have been prescribed to many patients by doctors, but the drug is not everybody’s friend. If you are in doubt, ask one of its victims -Mr Charles Oben. Like the petal of a flower dying before its full blossom, Oben has visited the land of the dead and lost his skin beyond recognition.

But thanks to the rapid response of a team of foreign doctors in United Kingdom, who rattled the disastrous effects of the drug, Oben is still alive today.

You would need to see what Charles Oben looked like at the beginning and peak of the illness, compared to what he looks like during a recent visit to Vanguard’s Corporate Headquarters in Apapa.

During the visit, Mr. Oben narrated his ordeal after innocently taking the drug allegedly manufactured by GlaxoSmithKline, GSK.

Narrating his experience, Mr. Oben said “It all started two years ago, after I took two pills of Zyloric drug, a product of GSK. ‘This was just between two-four months that I secured a new job with United Bank Africa, UBA, as the Human Resources Manager of the company.’’

Following the reaction generated by the drug, he had to undergo a cornea transplant which was recommended by the doctors. He eventually lost his tear glands in the process and is now placed on permanent steroids (lubrication of eyes).

Oben’s plight necessitated his decision to drag the company to an Ikeja High Court. In the suit, he is seeking for a compensation from GSK as well as an order of the court to immediately withdrawal Zyloric from national and international markets, to forestall further endangering peoples’ lives.

Tracing the genesis of his travails, Oben said it all started in Burkina Faso, where he had gone to work on secondment from UBA in Lagos, Nigeria.

While at Ouagadougou, Oben said his personal physician prescribed Zyloric to him as a drug that can help control the uric acid level in his lungs. Uric acid creates a condition that predisposes a person to joint pains.

“I was not sick before the prescription. I just went for a medical check up with my cardiologist in Burkina Faso. He ran series of tests and said my uric acid was a little high and prescribed Zyloric (known as Allopurinol in medical terms) to check it,’’ Oben said.

Following the doctor’s prescription, Oben alleged that he bought the drug from a pharmacist in Burkina Faso. But unfortunately for him, rather than getting a reprieve from two days of ingesting the drugs, he found himself in trouble.

“It started with severe peeling of my skin. Like a snake, I began shedding the skin on my hands, feet and back. Shortly, a red rash started spreading across the trunk of my body. Initially, I was taken to Pisam Hospital, Abidjan, Ivory Coast, for urgent medical attention.

But when the erosion of my skin could no longer be handled at that level, I was flown in an air ambulance to the Wellington Hospital in the United Kingdom where specialists eventually diagnosed me of Stevens-Johnson syndrome,” he explained.

Stevens-Johnson disease, is a very rare condition where cells in the body die and cause the epidermis – top layer of the skin – to separate from the dermis (inner layer of the skin.). The disease is said to be life threatening and mainly caused by medications and certain infections.

Considering the severity of his condition, Oben said he was promptly admitted and treated after series of blood tests on his kidney, liver and other vital organs.

According to him, while his treatment continued, his problem was compounded when he was sacked by his employer, on account of his deteriorating health and long absence from work.

Following his dwindling economic fortune, Oben said he was forced to return to Nigeria to seek solution to his health woes.

The worst according to him occurred, when he lost his sight in January 2010. For this, Oben reported at Premiere Eye Centre, Lagos, from where he was again referred to Wellington Hospital, UK.

Apart from losing his tears, Oben said he is worried that part of the medications he takes may be having adverse effects on his Kidney.

GSK legal manager GSK, Uchenna Uwechia, was quoted as saying that GSK Nigeria as a Nigerian pharmaceutical company licensed by the National Food and Drugs Administration and Control, NAFDAC, to produce drugs in Nigeria, does not sell or manufacture drugs in Burkina Faso and had never produced Zyloric.

He was also quoted as saying that he had not seen the drug before. According to him, Zyloric is not sold in Nigeria and wondered why GSK Nigeria should be liable.

GSK in the report also claimed that it had discharged its obligations by informing the public of the risks associated with the drug. But Oben claimed that the patients’ leaflets meant for African countries are not comprehensive compared to those in UK and USA.

In a another defence, the company claimed that “though the Zyloric trade mark was formerly owned by GlaxoGroup Limited, a member of the GSK Group, the said trademark was assigned to Aspen Global Incorporated on June 30, 2008. Consequently thereafter, the Zyloric drug was manufactured and sold under the authority of Aspen Global Incorporated.

The company is also contesting the jurisdiction of the court to entertain the case since the incident took place in Burkina Faso. The Vaccines Representative of the company in Lagos, Olushola Amosun when contacted by Vanguard told this reporter that he should find a better thing to do.

On why he is challenging the case in Nigeria, Oben said ‘’When I came to Nigeria, I wrote to GSK in UK and the legal Director GSK Nigeria said I should refer the matter to GSK Nigeria.

From the look of things, you do not know something until it happens. Efforts by Vanguard Features, VF to get the views of GSK’s Medical Director, Dr. Bode Adesoji failed, as he declined to respond to both email and text messages to his mobile phone.

Meanwhile, the Federal High Court sitting at Ikeja, Lagos will on October 27, 2011, rule on an application on whether the court has jurisdiction to entertain the N400 million damage suit instituted by a plaintiff, Mr. Oben against GSK Nigeria Limited.

Seroxat Secrets Asks: How Addictive Is Seroxat (Paxil) Mr David Wheadon (GSK)?


Interesting re-post from the Seroxat Secrets Blog.

Seroxat Secrets wrote extensively on the Seroxat Scandal up until 2013, and there are some brilliant posts in the archives there containing some important issues which GSK have yet to address… in particular the serious problem of Seroxat withdrawal…

height.200.no_border.width.200David3

11 images

https://seroxatsecrets.wordpress.com/2007/06/21/how-addictive-is-seroxat/

How addictive is Seroxat?

admin:

All this talk about Seroxat addiction and withdrawal reminded me of a post that I wrote back in 2007… I think it would be very interesting to see the data from the studies that Dr Wheadon spoke about while under oath in California.

Especially given what we now know about the lies GSK told about Study 329.

Originally posted on seroxat secrets…:

You might think that after all the years of doctors and patients all around the world saying Seroxat is highly addictive – oops, sorry, causes dependence and severe withdrawal reactions – that Glaxo would simply undertake the definitive study to prove us all wrong and to show the world once and for all really how safe and non-addictive Seroxat is…

Well, the truth is Glaxo could have done this years ago but it has not. Why? I leave that simple question to you to answer.

In fact, the official Paxil prescribing information (produced by Glaxo, current version) confirms this by saying:

DRUG ABUSE AND DEPENDENCE

Controlled Substance Class: PAXIL is not a controlled substance.
Physical and Psychologic Dependence: PAXIL has not been systematically studied in animals or humans for its potential for abuse, tolerance or physical dependence…

Again, I ask Glaxo why have no systematic studies been done? Why not put an end to all the stories about ‘poop out’ (tolerance) and withdrawal nightmares and prove once and for all what it says is true and we are wrong?

Or maybe, just maybe Glaxo isn’t telling us the whole truth…

The following exchange is from a transcript of a video deposition taken from Dr. David Wheadon, who was at the time, Vice President Regulatory Affairs and Product Professional Services, GlaxoSmithKline, in Philadelphia, PA on Thursday, October 19, 2000 prior to the Tobin/Schell civil suit.

Questioning Dr. Wheadon were California attorney Donald J. Farber and Texas attorney Andy Vickery.

Paxil Victim’s Attorney: I’m asking you to kind of elevate yourself above this particular paper and go to your general knowledge now on Paxil. You have been now with the company eight years, and you have studied and are aware, I presume, of Paxil’s traits in either causing or unrelated to addiction and withdrawal, and based on that general knowledge I think you probably have, do you consider as a labeling instruction today that this paragraph, physical and psychological dependence, is a good labeling instruction?

GlaxoSmithKline’s Dr. Wheadon: Well, quite frankly, it is an outdated labeling instruction, because there have been a number of systematic studies in humans looking at the potential for Paxil for abuse, tolerance and physical dependence. So actually, there is data to date to negate the statement that it has not been systematically studied, because, in fact, it has been.

I’m getting confused now – under oath, Dr Wheadon clearly stated Paxil (Seroxat) has been studied a number of times in humans looking at the potential for Paxil for abuse, tolerance and physical dependence…

Hang on though, the current, official Paxil prescribing information says that:

…PAXIL has not been systematically studied in animals or humans for its potential for abuse, tolerance or physical dependence…

So while Wheadon said one thing (under oath) in 2000, Glaxo says the EXACT OPPOSITE in its current official prescribing information.

The question remains – how addictive is Seroxat?

Who knows the answer – Glaxo or David Wheadon?

One thing is for sure, the public aren’t being told the truth…

Seroxat/Paxil Study 329 – the truth at last.


Seroxat Secrets was a fantastic blog, great to see the odd post coming back this year 🙂

seroxat secrets...

I’m feeling re-energised today for a number of reasons, one of them being the fact that I’ve discovered the final chapter in the story of Study 329 has arrived.

I suggest you visit Restoring Study 329 for the latest news.

Also have a look here at Bob Fiddaman’s excellent take on today’s news.

If you don’t already know, Study 329 is arguably the most controversial drug study ever, published in July 2001.

In a nutshell Study 329:

– concluded that Seroxat was a safe and effective medication for treating major depression in adolescents;
– is still widely cited in the medical literature, providing physicians with assurance about the usefulness of paroxetine;
– was criticised by a few alert and concerned journalists, academics and bloggers. (However, their voices were buried by a tsunami of positive marketing and promotion by vested interests);
– resulted in a successful New York state fraud lawsuit…

View original post 68 more words

Some Interesting Responses On The BMJ Site About The Restoration Of Paroxetine Study 329


http://www.bmj.com/content/351/bmj.h4629/rapid-responses

Re: No correction, no retraction, no apology, no comment: paroxetine trial reanalysis raises questions about institutional responsibility

It is refreshing to see the BMJ publish an article highlighting the corruption, collusion and dangerously unethical behaviors among the pharmaceutical and psychiatric industries, university medical departments and government “regulators.” I’d like to tell my teen-aged daughter all about the “retraction.” Unfortunately, she died from SSRI-induced akathisia, Serotonin Toxicity and prescribed suicidality. When she was experiencing life-threatening SSRI-induced side effects, her doctor did what many misguided doctors incompetently do: increased the toxin. Sadly, her death-and the deaths of hundreds of thousands of other innocent children, is not retractable.

Perhaps lawmakers might some day pass universal Informed Consent laws so that parents can be accurately informed prior to prescribing. Doing so would help better protect children from the torture and deaths that occur when profits are valued more than people…

Competing interests: No competing interests

18 September 2015
Kristina K. Gehrki
Educator & Advocate
None
Fairfax, VA 22030

Re: No correction, no retraction, no apology, no comment: paroxetine trial reanalysis raises questions about institutional responsibility

Thanks to Peter Doshi for his thorough overview of how the bastions of psychiatry and a top university ignored shoddy science, rampant conflicts of interest, ghostwriting, and the interests of children’s health (in my opinion) from the notorious study 329. Note the study and those involved played prominent roles in Boston Globe reporter Alison Bass’ 2008 book, Side Effects, “A richly detailed account of the disgraceful self-serving ties between drug companies and the psychiatric profession,” as described by former New England Journal of Medicine editor Arnold Relman.

Competing interests: No competing interests

17 September 2015
Susan Molchan
psychiatrist
Bethesda, MD

Paroxetine trial reanalysis raises questions about institutional responsibility

I wanted to say thank you for publishing this article. I was once on Paxil myself, as a newly 20 year old, for panic disorder without agoraphobia. While taking just 1/4 of the normal starting dose (5mg was my dose), I displayed flat affect and a “zombie” like appearance. This was within several weeks, about two. I then became suicidal.

For something that is supposed to be an ANTI-depressant, I’m amazed at how PRO mental disorder it truly was.

I’m a very happy woman, and was always a happy teenager. This was not normal. The small, sane part of my brain told me I needed to tell someone I was feeling this way, but I didn’t want to – they would try to stop me if I did tell someone. I will never forget what that feeling was like, and I truly wonder if I am a PTSD patient now because of it.

In the end, I did try to hurt myself. I was very lucky to have my mother and a very close friend stop me and take me to the doctor. They pulled me off Paxil completely and switched me to another SSRI and a benzodiazepine to ease the withdrawal side effects from the Paxil. I’ve been on this SSRI ever since, and it has now been about 10 years.

Everytime I see an article like this, my heart breaks. I truly hope that this research saves other adolescents from experiencing what I went through. I wouldn’t wish it on my worst enemy.

Competing interests: No competing interests

17 September 2015
Tracy Eisen
Student Nurse
Phoenix, AZ

No correction, no retraction, no apology, no comment = No science

Peter Doshi’s incisive commentary on the reactions to the RIAT re-analysis of Study 329 by its authors and the institutions, organizations, and corporations that stand behind them should be required reading for all mental health trainees — and, indeed, for all health care trainees.

Study 329 nicely illustrates the dangers that Marcia Angell pointed out in her 2004 volume, The Truth About the Drug Companies: How They Deceive Us and What to Do About It.

We all should be skeptics regarding hyped-up claims of efficacy — whether the agent is Paxil or CBT or psychoanalysis. We are only just beginning to understand the ways in which “body” and “mind” interact. New neuro-imaging techniques yield wonderful “pictures” of the brain . . . but these pictures might be usefully compared to what we see when we train a telescope on the night sky. Our vision is enhanced by a hundred-fold . . . but we still do not see more than the tiniest slice of what is really “out there.” The fact that we now can see so much more should not make us think that we now see the whole picture.

We also shouldn’t fall victim to another common error. The fact that an intervention is aimed at a specific target does not mean that the intervention affects only the target. [This is as true for psychoanalysis as it is for Paxil.] Our interventions always affect people in many unintended ways as well as those we intend.

Pharmaceutical advertisements usually give the impression that drugs affect a specific part of the body; they close their eyes to the fact that the drugs are disseminated throughout the body, with many unintended effects. [If they are mentioned, these “side effects” are put in small print, thus magically reducing their importance.]

Interventions aimed at affecting the mind are prone to the same error — but helping a person to “change their mind” often (or USUALLY) affects their life (and their relationships with others) in many unintended ways, too.

“Evidence-based medicine” or “empirically supported treatments” are put forth as a kind of gold standard these days. But “Restoring Study 329” demonstrates that we shouldn’t mistake iron pyrite (“fool’s gold”) for the real item, especially when someone has a vested interest in keeping a good bit of the evidence hidden from view. If we’re going to endorse “evidence-based medicine” we’d better be sure that we’ve got all the evidence and not just a cherry-picked subset.

Competing interests: No competing interests

17 September 2015
Paul M Brinich
Psychoanalyst. Clinical Professor (Emeritus) of Psychology and Psychiatry
University of North Carolina at Chapel Hill
Chapel Hill, NC 27516 USA

GSK ambiguity

Dr Doshi’s article might give the impression that an independent FDA review of the Study 329 data came to a different conclusion to GSK’s claims the trial had shown paroxetine worked. But in fact an approvable letter from FDA to GSK states: ” we agree that the results from … Study 329… failed to demonstrate the efficacy of Paxil in pediatric populations with MDD”. [but] “we agree that it would not be useful to describe these negative trials in the labeling”.[1]

In the media flurry surrounding these articles yesterday and today, GSK seem to lay the blame for a positive write up of the data on Keller and colleagues, while Keller and colleagues hint that GSK involvement compromised them. None of us – journals, regulators, academics, or doctors – come out of this with much credit.

1 http://2spl8q29vbqd3lm23j2qv8ck.wpengine.netdna-cdn.com/wp-content/uploa…

Competing interests: An author on Restoring Study 329, a founder member of RxISK.org and an expert witness in psychotropic cases both pro and con drug induced harms.

17 September 2015
David Healy
Doctor
Hergest Unit, Bangor

The Lieberman Speaketh..


“The group is a self-appointed watchdog,” Jeffrey Lieberman, chair of psychiatry at the Columbia University College of Physicians and Surgeons, told BuzzFeed News.

“One wonders what the motivation is, and how objective they’re going to be.”

Interesting comment by Jeffrey Lieberman (head shrink and Pharma friend extraordinaire) in regards to the publication of the new study on Paroxetine in the BMJ which shows how dangerous Paxil/Seroxat is in under 18’s. With estimates of hundreds of thousands of adolescents and kids put at risk from this fraudulent study, it’s quite remarkable that Lieberman attempted to just undermine and discredit the study, instead of expressing disgust at the risk of harm to children. Surely the risk is what should be discussed here? I would dare to suggest to Lieberman that perhaps some of the motivation from the authors of the re-write was in the interest of protecting kids from dangerous drug like Paxil? and perhaps some of the motivation was also- in part- because they believe in scientific integrity, ethics and informed consent?

These concepts might be alien to someone like Jeffrey Lieberman though, but even if they are let’s not allow someone who doesn’t understand (or value them)- attempt to undermine them. I had to laugh also when Lieberman tried to disparage the study further my bringing into question the ‘objectivity’ of it. Lieberman’s conflicts of interest with the pharmaceutical industry over the years would surely bring into question his personal and professional ‘objectivity’ when questioning a study which undermines pharmaceutical ghost-writing and the efficacy of psychiatric drugs- such as Paroxetine?

But the watchdogs were ready for that criticism. “All of us have conflicts of interest — namely, that we don’t like this study,” Nardo told BuzzFeed News. “The paper is so long because we were very careful to stick to the rules and show our work.”

See the Full post at Nardo’s excellent blog-

http://1boringoldman.com/index.php/2015/09/21/60048/

lost its mojo…

Posted on Monday 21 September 2015

One might think that with all of the supportive media coverage our Study 329 article has received, I would be able to shake off the response from lead author, Martin Keller, reproduced from Retraction Watch in the last post [keller responds…], or his comment in The Chronicle of Higher Education:
Dr. Keller contacted The Chronicle on Wednesday to insist that the 2001 results faithfully represented the best effort of the authors at the time, and that any misrepresentation of his article to help sell Paxil was the responsibility of Glaxo. “Nothing was ever pinned on any of us,” despite various trials and investigations, he said. “And when I say that, I’m not telling you we’re like the great escape artists, that we’re Houdinis and we did something wrong and we got away with the crime of the century. Don’t you think if there was really something wrong, some university or agency or something would have pinned something on us?” In what he described as his first effort to speak publicly about the matter, Dr. Keller said his critics also have financial and professional motives for amplifying criticisms, including lawyers representing Paxil plaintiffs and professors seeking their own records of journal publication…
I had a somewhat similar reaction to Dr. Jeffrey Lieberman’s comment:
“The group is a self-appointed watchdog,” Jeffrey Lieberman, chair of psychiatry at the Columbia University College of Physicians and Surgeons, told BuzzFeed News. “One wonders what the motivation is, and how objective they’re going to be.”
So I spent a day or so with a background chorus of refutations playing like a scratchy record in my mind until they played themselves out. Nobody reading this blog needs to hear them again. You could probably reproduce them yourselves, and I’ve certainly filled up enough pages saying them. After the din in my head subsided, I was left with just one clear note that I wanted to respond to. It is what has been characterized as the fallacy of an appeal to authority:
“The study authors comprised virtually all of the academic researchers studying the treatment of child depression in North America at the time”
In this case, the BY·LINE is indeed full of experts:
MARTIN B. KELLER, M.D., NEAL D. RYAN, M.D., MICHAEL STROBER, PH.D., RACHEL G. KLEIN, PH.D., STAN P. KUTCHER, M.D., BORIS BIRMAHER, M.D., OWEN R. HAGINO, M.D., HAROLD KOPLEWICZ, M.D., GABRIELLE A. CARLSON, M.D., GREGORY N. CLARKE, PH.D., GRAHAM J. EMSLIE, M.D., DAVID FEINBERG, M.D., BARBARA GELLER, M.D., VIVEK KUSUMAKAR, M.D., GEORGE PAPATHEODOROU, M.D., WILLIAM H. SACK, M.D., MICHAEL SWEENEY, PH.D., KAREN DINEEN WAGNER, M.D., PH.D., ELIZABETH B. WELLER, M.D., NANCY C. WINTERS, M.D., ROSEMARY OAKES, M.S., AND JAMES P. MCCAFFERTY, B.S.
But in spite of Dr. Keller’s claims otherwise, reading the raft of subpoenaed documents and the depositions, the author·ity appears to have rested on the shoulders of ghostwriter Sally Laden and perhaps the last two listed authors, both of whom were GSK employees [Deposition of Sally Laden, 2007]:
QUESTION: The document that I have marked as Exhibit seven is the final clinical report for Study 329 is that correct?
ANSWER: Yes
QUESTION: Is this a document that you were referring to that you got the data from?
ANSWER: I don t recall what specific document I did receive Whether it was this was one. I mean yes this would be what I would have gotten. I don’t recall getting it.
QUESTION: You don t recall ever receiving it but you know you got it right?
ANSWER: Yes I got it. Yes I don’t recall receiving it.
QUESTION: This provided you with information that you then utilized to prepare the first draft of the manuscript for Study 329?
ANSWER: Yes
QUESTION: Was it your responsibility alone to create the first draft of Study 329 or did you get help from some of your colleagues?
ANSWER: I believe I created it on my own.
QUESTION: Did Martin Keller tell you what to put in the first draft?
ANSWER: I don’t recall. I don t think I had any conversation with him until we were, you know, afterwards.
QUESTION: After you prepared the first manuscript?
ANSWER: To the best of my recollection, yes.
QUESTION: In here you list eight main outcome measures, correct?
ANSWER: Yes
QUESTION: And you can’t tell from reading – a reader could not distinguish which are these – whether any or all of them are primary or secondary?
ANSWER: Correct
QUESTION:  My question was do you know whose idea it was to not distinguish between primary and secondary efficacy measures?
ANSWER: A reader cannot. This was a first draft, so this came straight from me. This was, I guess, my interpretation. I’m remembering this may have been my interpretation of the data.
This is only one small example of the extent to which the appeal to authority has pervaded our literature. The experts are listed on the BY·LINE, but the work that matters is produced by the sponsor. In this case, the subjects were recruited and underwent the study at the institutions of the listed authors, but the article was drafted by the sponsor and written by a paid writer. This kind of “guest” authorship is common – the experts are involved, but not in the authorship as we understand the term. There are many other examples where the sponsors had already completed the papers before even recruiting the academic “guest authors” to sign onto the BY·LINE.

Similar experts with [financial] PHARMA COI are everywhere: CME presentations; Speaker’s Bureaus; Review Articles; the list gets longer by the year. A recent NEJM series [wtf?…, wtf? for real…] argued that their longstanding policy of banning authors with these COI from review articles should change [in part because there’s a paucity of “clean” experts]. The DSM-5 Revision was done using panels of experts heavily laden with COI tainted members [must be crazy…]. Expert “panels” produced the guidelines and algorithms for the infamous TMAP scam in Texas [1999…]. It appears that we have developed a “cult” of experts [called Key Opinion Leaders by the pharmaceutical marketers].

The Nizkor Project [a study of logical fallacies] lists among the instances where an appeal to authority is considered a logical fallacy:
  • If there is evidence that a person is biased in some manner that would affect the reliability of her claims, then an Argument from Authority based on that person is likely to be fallacious. Even if the claim is actually true, the fact that the expert is biased weakens the argument. This is because there would be reason to believe that the expert might not be making the claim because he has carefully considered it using his expertise. Rather, there would be reason to believe that the claim is being made because of the expert’s bias or prejudice.
  • If a person makes a claim about some subject outside of his area(s) of expertise, then the person is not an expert in that context. Hence, the claim in question is not backed by the required degree of expertise and is not reliable. It is very important to remember that because of the vast scope of human knowledge and skill it is simply not possible for one person to be an expert on everything. Hence, experts will only be true experts in respect to certain subject areas. In most other areas they will have little or no expertise.
In this case, when we were able to directly access the Individual Participant Data [IPD] and the Case Report Forms [CRFs] using the a priori Protocol as our guide for predefined Primary and Secondary Outcomes following their stated Statistical Analysis Plan, we could not confirm their claim of efficacy or of safety. Quite the opposite. The group listed on the BY·LINE may well be experts of one sort or another, but they are neither unbiased nor experts in analyzing Clinical Trial data. The notion that one can introduce a completely new outcome analysis at the end of a Clinical Trial lasting three years, whether before or after breaking the blind, and expect to be taken seriously in perpetuity is ludicrous – no matter what the explanation for the change. It’s equally bizarre to query 27 outcome measures [in the CSR] and ignore correcting for multiple variables. Likewise, the idea that Dr. Keller can claim that the article was written or analyzed by the experts on the BY·LINE when the hired medical writer testifies that she wrote the first draft [and others] from an industry supplied summary is equally absurd. And our paper was actually soft on some of the statistical manipulation along the way, but these comments apply in that arena as well.

I actually sometimes feel sorry for some  of the people on that BY·LINE. For some, I expect their error was in assuming that the analysis of the study was properly conducted. But my empathy is short-lived. I think they must’ve felt like it was a double return for their efforts. By doing the study on their site, they raised money for their departments AND they added an article to their respective resumes. What they got was anything but a boost to their status as experts. They delegated their author·ity to other experts who were operating deep in the domain of fallacy – then compounded and continue to compound the problem by their silence.

The appeal to authority argument has lost its mojo, not just in this trial, but in Clinical Trials in general. In our article, we concluded:
… As with most scientific papers, Keller and colleagues convey an impression that “the data have spoken.” This authoritative stance is possible only in the absence of access to the data. When the data become accessible to others, it becomes clear that scientific authorship is provisional rather than authoritative.

“The safety of paroxetine for adults is unclear”…” Study 329 led to Paroxetine being prescribed to hundreds of thousands of adolescents” (Professor Jureidini)


  • “This is highly concerning because prescribing this drug may have put young patients at unnecessary risk from a treatment that was supposed to help them,” he says.
  • Although concerns had already been raised about Study 329, and the way it was reported, the data was not previously made available so researchers and clinicians weren’t able to identify all of the errors in the published report,” said Professor Jureidini in a statement“It wasn’t until the data was made available for re-examination that it became apparent that paroxetine was linked to serious adverse reactions, with 11 of the patients taking paroxetine engaging in suicidal or self-harming behaviors compared to only one person in the group of patients who took the placebo.”
  • Jureidini suggested that the drugs’ side effects can make it easy to work out who is taking them. Potentially this may cast doubt, not just on this individual study, but on all clinical trials of SSRIs, one of the most widely prescribed classes of drugs in the world.
  • Publicity from Study 329 contributed to paroxetine being prescribed to “hundreds of thousands” of adolescents, Jureidini said. “We’re only talking about one study, but if this accurately reflects the effects we would expect that many children engaged in suicidal behaviour as a result.”
  • Jureidini told IFLScience: “The safety of paroxetine for adults is unclear. The safety analysis may be biased. But we know that the younger you are and the less severe the depression the more likely it is that the harms of SSRIs will outweigh the benefits.”

http://www.iflscience.com/health-and-medicine/study-antidepressant-safety-didnt-report-suicide-attempts