GSK Can’t Ax Out-Of-Staters From Ill. Paxil (Seroxat) Suit, Court Says


GSK Can’t Ax Out-Of-Staters From Ill. Paxil Suit, Court Says

http://www.law360.com/articles/833842/gsk-can-t-ax-out-of-staters-from-ill-paxil-suit-court-says

Law360, Boston (August 29, 2016, 5:06 PM EDT) — GlaxoSmithKline LLC had enough purposeful contacts with Illinois during clinical trials for the antidepressant Paxil for it to face claims from out-of-state residents that the company failed to warn that the drug could cause serious birth defects, a state appeals court ruled Friday.

The First District Appellate Court of Illinois, Fifth Division, ruled that the standard for a showing that a defendant’s conduct was “arising from” its contacts with the state was “lenient and flexible,” giving the state courts jurisdiction over the pharmaceutical giant. The decision in an interlocutory appeal upholds the trial court’s denial of GSK’s dismissal bid.

“In light of the lenient and flexible ‘arising from’ and ‘related to’ standard, plaintiffs meet the low threshold of a prima facie showing that their claims arose from defendant GSK’s Paxil trials in Illinois,” the appeals court said.

In the suit, eight minors from six states — Illinois, Florida, Colorado, Virginia, Michigan and Wisconsin — said that they suffered catastrophic birth defects because their mothers were taking GSK’s Paxil. The label failed to warn them of serious birth defects that the drug could cause, the plaintiffs said, and that was the result of inadequate clinical trials, 18 to 21 of which occurred in Illinois via 17 Illinois doctors. That meant that the claims arose directly out of or were related to GSK’s purposeful contacts with Illinois, the plaintiffs argued.

GSK argued that Illinois did not have jurisdiction over the out-of-state plaintiffs.

“GSK is disappointed by the court’s decision and is considering its options,” the company said in an emailed statement Tuesday.

Tor Hoerman, whose firm represented the plaintiffs, said in an emailed statement: “This decision is entirely in line with existing precedent of the Illinois Supreme Court and Appellate Court. … Drug makers who conduct inadequate or manipulated clinical trials in Illinois should not be surprised that they can be sued in Illinois for that conduct.”

In trying to have the suit dismissed as to the out-of-state plaintiffs, GSK said that its clinical trials occurred in 44 states and foreign countries, too attenuated for personal jurisdiction in one state where it’s not headquartered. Its alleged acts or omissions in Illinois were not the “but for” cause — in other words, GSK said, the plaintiffs couldn’t show that the harm would not have occurred but for what GSK did in Illinois.

In addition, GSK argued, the plaintiffs weren’t study subjects there, and the out-of-state plaintiffs didn’t take Paxil or suffer injuries in Illinois.

The children and their mothers argued that GSK had meaningful contacts with Illinois through its clinical trials of Paxil, during which they said it failed to track 18 pregnancies, one of which resulted in a heart defect. According to Friday’s decision, GSK employs 16,323 people in the U.S., including 217 who reside in Illinois, and from 2000 to 2006, GSK had between 79 and 121 employees marketing Paxil in Illinois.

They did not have to prove that any act was committed in Illinois, but just make a prima facie showing, the defendants said.

In a ruling Friday, the appeals court sided with the plaintiffs.

“The quality of defendant GSK’s relationship with Illinois can hardly be characterized as random, attenuated or the like; the contacts with Illinois, over the course of two decades, were purposeful and directed,” the appeals court ruled.

The plaintiffs, and the judges, used some of GSK’s own statements to show that the case could continue. In a declaration, GSK said that the principal Paxil investigators had “little or no input into or control over the study design protocol or analysis of the aggregate data collected from all study sites.”

“As plaintiffs argue, the word ‘little’ invites the inference that the physicians had some degree of input into, and control over, the clinical trials, or else the word would have been omitted,” the appeals court said. Absent further guidance in the record, we ‘resolve in favor of the plaintiff any conflicts in the pleadings and affidavits.’”

Judges Robert E. Gordon, Bertina E. Lampkin and Eileen O’Neill Burke sat on the panel for the First District.

GlaxoSmithKline is represented by Dentons.

The plaintiffs are represented by Ken Brennan of TorHoerman Law LLC.

The case is M.M., a minor, et al. v. GlaxoSmithKline LLC et al., case number 1-15-1909, in the Appellate Court of Illinois, First District, Fifth Division.

–Editing by Mark Lebetkin.

Update: This story has been updated to include a comment from GSK.

Dr Peter Breggin: $11.9 Million Paxil Suicide Verdict: The Inside Story


https://www.madinamerica.com/2016/10/11-9-million-paxil-suicide-verdict-inside-story/

$11.9 Million Paxil Suicide Verdict: The Inside Story

No one expected a very large award, let alone $11.9 million, in this suicide malpractice case involving the antidepressant Paxil (paroxetine). The jury verdict on September 15, 2016 was gratifying and encouraging (Family of Pennsylvania jail suicide victim awarded $11.9M$11.8M Federal Medical Malpractice Verdict For Prison Inmate’s Suicide). It demonstrates that the judicial system and the public are becoming increasingly aware of the hazards of psychiatric drugs, including their capacity to make people behave in ways that are harmful to themselves and others, and contrary to their past behavior and character.

Great success seemed unlikely in this case. To begin with, suicide malpractice suits are very difficult to win. Juries understandably want to hold people responsible for their behavior when they kill themselves. I was going to testify that a single dose of Prozac 30 mg was the main cause of his suicide, a conclusion that other experts would vigorously challenge.

In addition, the case was in an area of the country where juries are conservative about giving monetary awards to plaintiffs. It was in the U.S. District Court for middle Pennsylvania in the city of Scranton.

Juries also tend to look askance at claims made on behalf of people in jail.  Mr. Mumun  Barbaros, the deceased victim, was in his fourth day of incarceration, awaiting release on bail. The judge did not allow the jury to know the nature of his alleged crime or the charges against him, and I was not permitted to comment on them. If allowed, I would have testified that Paxil-induced disinhibition drove him to vandalize the property of a man in a competing business.

Some people are also less sympathetic to naturalized citizens with strong ties to their countries of origin. Mr. Barbaros was a Bulgarian who became a citizen, but his wife and children spent only part of the year with him and he sent back large amounts of his earnings from his tavern to his extended family back home.

Finally, the case had scientific complexities that the jury had to understand.

The defendants were the independent healthcare provider to the jail, PrimeCare, and several of its personnel or contractors assigned to the jail. Mr. Barbaros had been taking Paxil for anxiety for many years, along with the sedating antidepressant trazodone to help him sleep.

At the time of his arrest, Mr. Barbaros reported that he needed his medication.  Due to a series of errors upon the part of the healthcare personnel, his request for medication went unfilled for four days.  By the second and third day, Mr. Barbaros develop headaches and hypertension, and his chronic stomach problem worsened, but no one attributed these symptoms to withdrawal. However, his intake evaluation and contacts with healthcare providers documented an absence of suicidal thoughts and revealed no great distress.

When the staff finally confirmed Mr. Barbaros’ medications, a licensed practical nurse (LPN) from the jail phoned the psychiatrist on call and asked him to prescribe the Paxil 30 mg and trazodone 100 mg. The LPN did not offer the doctor any information about Mr. Barbaros, such as his age, the reason he was taking the medications, how long he had been taking them, and how long he had been without them in jail. The psychiatrist, in turn, did not ask the nurse any questions, but simply authorized the drugs.

I testified that the psychiatrist’s actions were worse than practicing medicine negligently—he was not practicing medicine at all. He was more like a vending machine. I further testified that this was callous disregard, especially since he admitted to knowing that the drug had dangers associated with it, including suicide, and yet asked no information about the patient, did not come in to see him, and ordered no special supervision.

Following his first morning dose of the Paxil, Mr. Barbaros was seen for a routine evaluation by a staff psychologist in the mid-afternoon. At this point, Mr. Barbaros was drastically changed. He was no longer a man who conversed easily and showed no signs of significant stress, anxiety or depression. According to the psychologist’s deposition, Mr. Barbaros now looked extremely anxious and like a “cornered rat,” spoke very little, made poor eye contact, and looked hunched over and withdrawn. In the psychologist’s scantily written report, his only diagnosis was “rule out depression,” an entirely new diagnosis for Mr. Barbaros.

I attributed these drastic changes in Mr. Barbaros’ condition to the impact of the large dose of Paxil. The psychologist had not checked to see what medications Mr. Barbaros was taking. He did not check the medical record and therefore did not know that his current severely anxious and withdrawn state was entirely new for him during his incarceration.  He did not ask his patient if he was suicidal.

In my direct examination, I testified that restarting the patient on his regular dose of Paxil 30 mg, despite a hiatus of at least four days without the medication, was a direct cause of the suicide later on the same day. Restarting him on Paxil 30 mg, when most of the drug was out of his system, caused akathisia (agitation with hyperactivity) and suicide. I also found that the doctor and the psychologist were negligent in several other ways, including their failure to evaluate the patient and to order careful monitoring.

I further explained that Paxil (paroxetine) is a selective serotonin reuptake inhibitor (SSRI) antidepressant. All antidepressants can cause suicidal and homicidal behavior, especially those like the SSRIs that routinely cause stimulation or activation, including akathisia, agitation, insomnia, disinhibition, emotional lability, hypomania and mania, and a general worsening of the patient’s condition. Of all the antidepressants, Paxil was the only one to show a statistically significant association with suicide in depressed adults in the short and deeply flawed clinical trials used for FDA approval of the drug.

To back me up, I brought a number of documents, including a 2006 letter from the manufacturer to all healthcare providers admitting to the association between Paxil and suicide in depressed adult patients, and further warning that this risk might apply to patients with other diagnoses. I also brought a copy of the 2006 Full Prescribing Information for Paxil that carried the same warning about suicide in adults, before the drug company got the FDA to delete it in later editions. I had written about the subject of medication-induced suicide in my book, Medication Madness: The Role of Psychiatric Drugs in Cases of Violence, Suicide and Crime.

One of the more dramatic moments in my testimony came on the first series of questions during cross-examination. When I began reviewing the case, I was asked to focus on Mr. Barbaros’ medical record going back approximately six years to the time when his primary care doctor had started him on Paxil 10 mg, apparently without difficulty, and then raised it gradually to 20 mg and then 30 mg. To be thorough, I examined all the remaining extensive medical records and came upon something remarkable buried within them that had previously escaped attention.

The day after his first dose of Paxil 10 mg, Mr. Barbaros became so anxious that he thought he was having a heart attack and sought immediate help at a local medical clinic separate from his primary care physician who prescribed the Paxil. That clinic referred him to a cardiologist on an emergency basis who evaluated him and found no physical disorder. These doctors treated Mr. Barbaros’ anxiety with prescriptions for a benzodiazepine tranquilizer.

Mr. Barbaros had experienced a very severe anxiety reaction to his first dose of Paxil, but it apparently never entered his mind that Paxil was causing it. From the medical record, it looks like he never told the emergency clinic or the cardiologist he had recently started taking Paxil and he never told his primary care doctor, when he returned for follow up later on, that he had been so anxious that he went to a cardiologist and received sedative tranquilizers. It is very common for individuals to fail to realize that their acute psychiatric emergencies are being caused by their psychiatric medication.  I call this phenomenon “medication spellbinding” or intoxication anosognosia.

As a medical expert in a product liability case against GlaxoSmithKline, the manufacturer of Paxil, I had discovered from the company’s secret files that Paxil frequently caused severe psychiatric adverse reactions during the first few doses. I had published an article about this in the hope of alerting people to the risk. This earlier work of mine enhanced the credibility of my discussion.

So… when I was asked at the beginning of cross-examination to explain why Mr. Barbaros would have such a bad reaction to being restarted on Paxil since he never had a bad reaction to being started many years earlier, I had an unexpected answer. I could reply and document from the medical records that, in fact, he had a drastic psychiatric reaction to the original 10 mg dose but no one recognized that it was related to the Paxil. The defense attorney was so flummoxed by my revelation that he never even asked to see the relevant medical records. The cross-examination then went on for an unexpectedly long time, requiring me to come back a second day. The defense probably was hoping that the jury would forget the revelation I had disclosed in the first few minutes.

The jury not only found that PrimeCare and several of its practitioners and staff had been negligent, they further concluded that the company and most of the individual defendants acted with deliberate indifference to Mr. Barbaros’ medical needs.

Despite a vigorous challenge by the defendants’ attorneys, the judge qualified me as an expert in psychiatry, psychopharmacology and the specific drug Paxil. In the trial, other experts testified for the plaintiffs concerning the nursing care and administrative policies of the healthcare provider, as well as the violent method of Mr. Barbaros’ death by gagging himself.

The jury award included $2.8 million for negligence, $1.06 million for federal deliberate indifference and $8 million for punitive damages. The case is Ponzini et al. v. Monroe County et al., case number 3:11-cv-00413, in the U.S. District Court for the Middle District of Pennsylvania. The attorney for the plaintiff was Brian Chacker of Philadelphia. He worked extraordinarily hard and with great diligence on the case.

I do believe that the success of this case reflects greater awareness within the public and the judicial system concerning the dangers of psychiatric drugs.

The Paxil/Seroxat Study 329 Story In 2016: Project Censored : Downplayed stories illuminate larger patterns in inequality, spying, the environment and corporate influence ..


http://www.sfreporter.com/santafe/article-12640-project-censored.html

Crisis in Evidence-Based Medicine

The role of science in improving human health has been one of humanity’s greatest achievements, but the profit-oriented influence of the pharmaceutical industry has created a crisis situation. That research simply cannot be trusted. Burying truth for profit is a recurrent theme for Project Censored. The top story in 1981 concerned fraudulent testing from a single lab responsible for one-third of the toxicity and cancer testing of chemicals in America. But this problem is much more profound.

“Something has gone fundamentally wrong,” said Richard Horton, editor of The Lancet, commenting on a UK symposium on the reproducibility and reliability of biomedical research: “Much of the scientific literature, perhaps half, may simply be untrue. Afflicted by studies with small sample sizes, tiny effects, invalid exploratory analyses and flagrant conflicts of interest, together with an obsession for pursuing fashionable trends of dubious importance, science has taken a turn towards darkness. … The apparent endemicity of bad research behavior is alarming.”

Horton’s conclusion echoed that of Marcia Angell, a former editor of the New England Journal of Medicine, who went public in 2009.

A classic case was Study 329 in 2001, which reported that paroxetine (Paxil in the United States and Seroxat in the United Kingdom) was safe and effective for treating depressed children and adolescents, leading doctors to prescribe Paxil to more than 2 million US children and adolescents by the end of 2002 before being called into question. The company responsible (now GlaxoSmithKline) agreed to pay $3 billion in 2012, the “largest healthcare fraud settlement in US history,” according to the US Department of Justice.

Nonetheless, the study has not been retracted or corrected, and “none of the authors have been disciplined,” Project Censored points out. This, despite a major reanalysis which “‘starkly’ contradicted the original report’s claims.” The reanalysis was seen as the first major success of a new open data initiative known as Restoring Invisible and Abandoned Trials.

While Project Censored noted one Washington Post story on the reanalysis, there was only passing mention of the open data movement. “Otherwise, the corporate press ignored the reassessment of the paroxetine study,” and beyond that, “Richard Horton’s Lancet editorial received no coverage in the US corporate press.”

Source: The Lancet 385, no. 9976, 2015; Cooper, Charlie, “Anti-Depressant was Given to Millions of Young People ‘After Trials Showed It was Dangerous,’” The Independent, 2015; Boseley, Sarah, “Seroxat Study Under-Reported Harmful Effects on Young People, Say Scientists,” The Guardian, 2015.

The Seroxat Teen Suicides Can’t Be Swept Under The Carpet By GSK’s PR Stunts…


Adrian Keegan..

A Stolen Life From GSK’s Seroxat…

One of many thousands…

It’s because of stories like this that I blog…

Do you think GSK’s Andrew Witty, or GSK’s CEO Designate- Emma Walmsley- give a damn about the immeasurable suffering Seroxat has caused so many people for so many years?.. or is it just business as usual- profits, stock-options, and money, that occupies their corporate brains?…


http://www.thepillthatsteals.com/stolen-lives/#/ian-26/

I’m Dawn from Shropshire and my son Adrian had his life stolen by Seroxat at the age of 19. 

After a break up with his girlfriend Adrian went to his doctor,  was  diagnosed with depression and was prescribed seroxat on 5 November 2001.   26 days later he took his own life. He lived in a rented flat but  a few weeks after he took the tablets he  came round very agitated and said he  wanted to kill someone. He was very fidgety and not himself.

  1st December on the way to work we pass Adrian’s flat and we saw his lights were still on. My husband dropped me off at my place of work and went to the flat. …he broke down the door when he got no answer to his Knocking. ….he Found Adrian in the bathroom he had hung himself with his belt. …..

We spoke to Adrian’s friends a few days later and they had been with him Thursday 29th  till 10 pm and said he wasn’t himself. Adrian was 6ft 2 in and a strong handsome young man I know he would never have killed himself it was the antidepressants that made him think that he wanted to


SSRI use in pregnancy linked to speech, language disorders in offspring….


http://www.medicalnewstoday.com/articles/313441.php

SSRI use in pregnancy linked to speech, language disorders in offspring

BBC Journalist Seeking People Who Have Experienced Withdrawal From SSRI Anti-Depressants For A Documentary…


http://survivingantidepressants.org/index.php?/topic/13214-bbc-journalist-looking-to-expose-problems-of-withdrawal/

https://twitter.com/lesleyashmall?lang=en

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Posted 04 October 2016 – 07:07 AM

I’m a British BBC TV reporter and I want to make a film about the problems of withdrawing from antidepressants. I’m keen to hear from people who’ve struggled with SSRIs, particularly if you like in the UK. Also what you think about the lack of support groups, or if you HAVE a support group, how do you help?

Please email me your stories, confidentially at first, of course, although ultimately I’m looking for people who will be willing to stand up and speak about what’s happened to them.  I think few people know or report this sort of problem and I know many of you are really really struggling for help.  My BBC2 programme wants to expose all this, so please get in touch.

Lesley.ashmall@bbc.co.uk

Thank you very much.  This forum has been recommended to me by several long-term members, so forgive my intrusion.

Katinka Newman… The Pill That Steals Lives… Another SSRI Anti-Depressant Horror Story…


 

Published on Sep 29, 2016

While going through a divorce, filmmaker Katinka Blackford Newman took an antidepressant to help with insomnia. She had no idea she is one of the 1 % of people who suffer severe adverse reactions to antidepressants. She went into a toxic delirium, believing she had killed her children and, in actual fact, stabbing herself. When admitted to hospital, doctors didn’t realise it was the pill that made her ill. She was given more antidepressants and antipsychotics which resulted in a year-long illness. It was luck she got better when she was admitted to a hospital that detoxed her from all the drugs. She and her children began a journey of discovery which became the subject of her bestselling book, The Pill That Steals Lives: One Woman’s Journey to Discover the Truth About Antidepressants. She discovered a hidden epidemic of people whose lives have been destroyed by side effects of these pills, and that courts around the world have ruled that people have killed themselves and others as a result. She has begun a campaign, http://www.thepillthatsteals.com to promote awareness of the dangerous side effects of antidepressants . This film tells the story of what happened to her, her kids and some of the people she knows.

Songwriter Dylan Tighe Discusses His Prescription Of The Suicide Drug Seroxat At 19…


Dylan’s story eerily echoes, very closely ,to my personal Seroxat story..

One which I will be bringing to closure soon on this blog…


 

 

Dylan Tighe: ‘Instead of relieving my distress, I felt the drugs were compounding it’  The first time Dylan Tighe, who is 34, attended a psychiatrist was at the age of 18, after experiencing a prolonged bout of depression. “I just felt listless. There was a complete lack of desire and absence of joy that was overwhelming. It was an experience that would be repeated again,” says the award-winning theatre director.

After a brief consultation, he was prescribed Seroxat, an antidepressant, for the best part of a year. It was the beginning of several years of being prescribed a range of antidepressants and mood-stabilisers which, he says, had often severe side effects, such as an increased heart rate, short-term memory loss and sexual problems. In the meantime, he felt other options weren’t being made available, such as talk therapy, which might helped him resolve underlying issues. “Drugs were always the first port of call. There was a dismissive attitude towards talk therapy . . . instead of relieving my distress, I felt the drugs were compounding it.

“My engagement with the service and lack of choice disempowered me to the point where I’m sure it was a factor in the depression itself. “I found the relationship between the psychiatrist and patient quite patronising. They are the ones with the knowledge and power. Yet, all the assumptions on which I was being prescribed medication were very challengable – but it’s difficult to do so when you’re at a very vulnerable point.”

He says he would have liked to have been listened to about what he felt would work in his case – but says there was little leeway outside of the medical approach. After exploring options on his own, he found psychotherapy “infinitely more helpful”.

“The most helpful therapists were those with the most empathy. That was almost totally absent from psychiatry, in my experience.” Tighe hasn’t used drugs for about two years. He has serious reservations about psychiatric medication, but accepts that some people find them helpful. “You can’t generalise. Everyone’s different. In my case, I was told I may have to take them for the rest of my life, so I feel an enormous sense of relief now that I made a choice to stop taking them.”

Tighe is now putting the finishing touches to an album and stage production called Record, which will draw on his experiences of the mental health system. It will premiere at the Cork Midsummer Festival on June 25th and will go on to tour nationally. “The material uses my starting point of diagnosis and examines the area of emotional distress and ideologies around psychiatry, and looks towards a new way of conceptualising emotional distress . . . I feel I’ve made huge progress in coming to my own understanding of my experiences, which has been very empowering and enlightening.”


Published on Jan 6, 2015

RESOLUTION is a creative exploration of life from people who have met adversity and challenge with courage and compassion. People who are living from the inside out…

Dylan Tighe: Musician,Theatre-Maker,Writer


http://www.mindfreedomireland.com/index.php/articles-from-2012/1002-carl-o-brien

Dylan Tighe’s debut album Record, inspired by his personal experiences of emotional distress and of the mental health system, was released in February 2014 to widespread acclaim. The Sunday Times declared Dylan an “exquisite songwriter”,while RTÉ proclaimed the album “starkly brilliant” and “a deeply personal and deeply moving piece of work”. The Irish Times described it as “brimming with tunes” and “an audacious and seriously intelligent suite of songs. Dylan has also worked extensively as an actor and theatre-maker, winning the Irish Times Theatre Award for Best Production in 2010 for his production ‘No Worst There is None’ inspired by the ‘dark sonnets’ of Gerard Manley Hopkins. His stage production Record based on songs from the album at Cork Midsummer Festival and Dublin Theatre Festival was described by the Irish independent as proposing “a new theatrical form for a new way of thinking”.

A radio version for RTÉ, featuring songs from the album and challenging a scientific view of mental health, was nominated for the Prix Europa prize 2014. He has recently contributed a chapter entitled ‘Start Making Sense’ to ‘Madness, Psychiatry, and Performance’, newly published by Palgrave. A new work for radio- ‘Pulse Music/ Ceol Cuisle- about the poet Michael Hartnett and created in collaboration with musician Seán Mac Erlaine, was recently broadcast on RTÉ.
Dylan


https://beyondmeds.com/2013/04/28/dylan-tighe-record-questioning-a-scientific-view-of-mental-health-play-features-madness-radio/

Dylan Tighe – “RECORD: Questioning A Scientific View of Mental Health” Play Features Madness Radio

FINAL_DYLAN_big

Dylan Tighe’s new play “RECORD: Questioning A Scientific View of Mental Health” Features Madness Radio!

You can listen to it here and there’s more info about Dylan and the show here 

Theatre-Maker and musician Dylan Tighe uses his own psychiatric history to probe some of the assumptions underpinning a scientific view of mental health. The play proposes artistic expression, and lived experience- as capable of offering insights into the mind (and heart) which science cannot penetrate. This alternative record of mental health centres around Dylan Tighe’s psychiatric records and personal research and includes songs from his debut album RECORD exploring his diagnosis and experience, along with a collage of sonic and musical sources, documentary, dramatic scenes and archive samples relating to the science behind the concept of “mental illness”

Credits:

Director, Writer, Original Music: Dylan Tighe, Actors: Aoife Duffin, Daniel Reardon, Dylan Tighe, Sound Design: Jimmy Eadie, Sound Supervision: Richie McCullough, Producer: Kevin Brew

Songs are from Dylan’s debut album RECORD, produced by Jimmy Eadie and feature Dylan Tighe (Guitars and vocals) Conor Murray (Drums), Seán Mac Erlaine (Sax and Woodwinds), Donal Mac Erlaine (Saw) and Cian Murphy (Double Bass). Album available at I-tunes, amazon and  Dylan Tighe’s website.

Samples of interviews with David Cohen, Gary Greenberg, John Horgan, Jay Joseph, Robert Whitaker, and the voice of Will Hall, appear courtesy of Will Hall and Madness Radio

Featuring the voices of former Taoiseach (Irish prime minister) Bertie Ahern, Antonin Artaud, Dr Pat Bracken, Dr. Peter Breggin, Dr. Andrew Harkin, Prof. Jim Lucey, Pat Kenny, Mary Maddock, John Mc Carthy, Seán Rocks.

Additional music by Mary Maddock. Dramatic scenes were inspired by Ingmar Bergman’s 1966 film ‘Persona’.

Psychiatrist Mickey Nardo’s Latest Post On GSK Study 329…


http://1boringoldman.com/index.php/2016/06/22/out-of-this-mess/

Posted on Wednesday 22 June 2016

David Healy, Jon Jureidini, Bernard Carroll, and Ben Goldacre

Some day there’ll be a best seller, a popular science book that will tell a story currently still in the making – and near the beginning the book will have a chapter about the interchange between David Healy and Charlie Nemeroff in Toronto in 2000 when Healy lost a new job because he talked about the potentially fatal side effects of SSRI [and Nemeroff, then boss of bosses] undermined his job change in retaliation. And there will be a piece about how Jon Jureidini, a pediatric psychiatrist, publicly protested a published study in 2003 that fraudulently claimed that a SSRI was safe and effective in adolescent depression. And that best-selling-author-to-be will add the efforts of Bernard Carroll and Bob Rubin in 2003 and later 2006 in exposing that same Charlie Nemeroff and others for promoting treatments they had a personal financial interest in without acknowledging those interests. Then there’s Ben Goldacre who will be cited for calling attention to the essential role of data transparency in bringing the truth to light with the AllTrials initiative, or getting at a major mechanism of deceit with his COMPare project. There will be so many more who will figure into this unfolding story. But right now, in spite of a lot of prequels, that book can’t be written because the story’s not over yet. Sure enough, there’s been progress but the main story line continues, lacking an in·place general solution…

Recently, the pioneers have been mighty busy. In September, David Healy, Jon Juriedini, and their colleagues republished the 2001 study that had become a paradigm for a jury-rigged Clinical Trial report, reanalyzing it from the original dataset using the author’s own Protocol and found that despite the earlier claims, the drug was neither effective nor safe in adolescents [Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence]. Then in March, Jon Juriedini and some other colleagues were back with another SSRIs·in·adolescents·study, this time with access to internal documents showing again how a negative Clinical Trial had been published as positive [The citalopram CIT-MD-18 pediatric depression trial: Deconstruction of medical ghostwriting, data mischaracterisation and academic malfeasance]. This study had been used as a basis for FDA Approval, and used the same technique of altering the a priori protocol – something Ben Goldacre‘s COMPare project calls “outcome switching.”

We now know that this problem of misreported Clinical Trials will never be solved so long as the raw data remains hidden. Without access to that information, we’ll never put a stop to these dark days of pseudoscience in the medical literature. But that’s not enough, because it’s the analysis of that data where the misbehavior has been centered. Today, one of those pioneers has a blog post that suggests a viable next step, a concrete general solution to the problem:
Health Care Renewal
by Bernard Carroll
June 22, 2015

There is a disconnection between the FDA’s drug approval process and the reports we see in medical journals. Pharmaceutical corporations exploit this gap through adulterated, self-serving analyses, and the FDA sits on its hands. I suggest we need a new mechanism to fix the problem – by independent analyses of clinical trials data.

When they analyze and publish their clinical trials in medical journals, pharmaceutical corporations have free rein to shape the analyses. The FDA conducts independent analyses of the data submitted by the corporations, and it may deny or delay approval. But the FDA does not challenge the reports that flood our medical journals, both before and after FDA approval. It is no secret that these publications are routinely biased for marketing effect, but the FDA averts its gaze. That failure of the FDA – a posture known as enforcement discretion – has been well documented. The question is why? At the same time, exposing the biases has been difficult for outsiders because the data are considered proprietary secrets.
This is just a teaser. The whole post is on-line. In the next section, Carrol outlines the problem using Juriedini’s latest paper as a case example then proposes a solution:
A Specific Proposal
Our primary defense against such perversions of scientific reporting is fidelity to the registered IND protocol and plan of statistical analysis. The solution is not hard to see: We need independent analyses of clinical trials because we cannot trust the corporate analyses. In effect, we need something like the Underwriters Laboratory to verify the statistical analyses of clinical trials. Nobody takes the manufacturing corporation’s word for it concerning the safety and performance of X-ray machines or cardiac defibrillators. Why treat the statistical analysis of drug trials any differently? It’s highly technical work. Who should assume that responsibility? Why not the FDA? After all, they alone see all the data. My specific proposal is for Congress to mandate that the FDA analyze all clinical trials data strictly according to the registered protocols and analysis plans. That requirement should apply to new drugs or to approved drugs being tested for new indications. It should apply also to publications reporting new trials of approved drugs. Corporations and investigators should be prohibited from publishing their own in-house statistical analyses unless verified by FDA oversight.
There follows a section on why the time to act is at hand and the potential counterarguments:
It is time for Congress to grasp this nettle. The time for enforcement discretion is past, and we need Congress either to direct the FDA to act or to create a new mechanism of oversight. To do nothing would be unthinkable.

There are other suggested solutions beginning to appear and I’ll cover some of them in subsequent blog posts. But this one comes first because it’s the one that makes the most sense to me. In all of the work that went into our Paxil Study 329 paper where my part was the efficacy analysis, I became convinced that insisting that the analyses follow the a priori Protocol and Statistical Analysis Plan to the letter is the only way to insure that the analysis is worthwhile. After we finished our paper, I went back and looked and every questionable trial I’d looked at had suspicious variables. My problem was that finding those Protocols was spotty. My hat’s off to Goldacre’s team for being able to run them down. The other ubiquitous problem was from inappropriate statistical testing. So Carroll’s proposal seems right as rain. The FDA has the capabilities to do the analyses, and already does them in many cases.

I picked the four investigators up top, not because they work together, or even necessarily agree. I picked them because each has been a central part of my own growing understanding of a way out of this mess. My way of saying “thanks!”

Update: Dr. Carroll’s proposal was cross posted on Naked Capitalism with some interesting comments.