Dr David Healy Cleared To Testify In Paxil Suicide Case…


Where does the buck stop?

http://www.law360.com/productliability/articles/865174/expert-ok-to-testify-in-gsk-suit-by-reed-smith-atty-s-widow?nl_pk=e32b9586-8e50-4282-bd7d-fc0e212e42e7&utm_source=newsletter&utm_medium=email&utm_campaign=productliability

Expert OK To Testify In GSK Suit By Reed Smith Atty’s Widow

Law360, New York (November 22, 2016, 3:11 PM EST) — An Illinois federal judge on Monday canceled a pretrial hearing scheduled to vet an expert witness for the widow of a former Reed Smith LLP partner who killed himself allegedly as a result of taking GlaxoSmithKline PLC’s antidepressant drug, finding that the expert’s past issues had already been settled.
Dr. David Healy, who’s set to testify on behalf of widow Wendy Dolin when her trial against GSK begins in January, was scheduled first to take part in a pretrial hearing regarding an investigation into a past patient incident by the General Medical Council, the governing board of medicine in the United Kingdom where his practice is located.

However, that investigation has since closed with no finding of wrongdoing, and the Illinois federal court’s in camera review of documents related to the council’s inquiry have turned up nothing either, therefore a hearing to vet Dr. Healy is no longer warranted, U.S. District Judge William T. Hart decided.

“As stated by this court before the GMC investigation was closed ‘investigations, without finding of culpability, are typically not relevant.’ Moreover, there is nothing in the in camera documents to warrant a hearing or disclosure of the documents. Accordingly, no pretrial hearing of Dr. Healy’s testimony will be held,” Judge Hart wrote.

The judge indicated that the court would hang onto the in camera documents until the conclusion of the trial, which is set to begin Jan. 17.

“This case is about Paxil-induced self-harm, not a medical board investigation where Dr. Healy was cleared of any wrongdoing and had nothing to do with Paxil,” Robert Wisner of Baum Hedlund Aristei & Goldman PC, an attorney for Dolin, told Law360. “GSK wants to distract the jury with any and everything that does not center on GSK’s conduct. The court, thankfully, saw through it.”

A representative for GSK declined to comment.

Dolin had asked Senior U.S. District Judge James B. Zagel in August to cancel the December hearing over Healy after the General Medical Council cleared him in an investigation following the suicide of one of his patients.

Judge Zagel had requested the hearing to determine whether GSK could ask Healy about the council’s investigation in front of the jury during the upcoming trial. But Dolin had argued that GSK’s investigation-based attacks on Healy were no longer relevant to the case.

Dolin sued GSK and Mylan Inc. in 2012, two years after her husband, Stewart, threw himself in front of a train. He began taking Mylan’s generic form of GSK’s antidepressant Paxil just a few days before his death.

Wendy Dolin claims GSK covered up an increased risk of suicide associated with Paxil by manipulating data used in a study that was submitted to the U.S. Food and Drug Administration. She also wants GSK held liable for failing to include a warning on its packaging about the risk.

For more than a year now, the parties have battled over Healy, a British psychiatrist who will testify for the widow about his research into the causal relationship between Paxil and adult suicide. While under investigation by the council, Healy wrote on his blog that he was likely being targeted by major drug manufacturers like GSK because of his testimony in various cases against the companies.

After Judge Zagel ensured the case would go to trial by declining to rule on GSK’s summary judgment bids earlier this year, GSK pressed him to force Healy to reveal documents related to the council’s investigation, arguing they were relevant to Healy’s credibility and potential bias against the drugmaker. Dolin countered, saying the public filing of the documents could cost Healy his job.

Judge Zagel denied GSK’s efforts to get the documents, which were submitted to the court for in camera review, but said he wanted to hold a special hearing to determine whether the U.K. investigation is relevant to the Dolin case.

Dolin is represented by R. Brent Wisner, Michael L. Baum, Bijan Esfandiari and Frances M. Phares of Baum Hedlund Aristei & Goldman PC, and David Rapoport, Joshua L. Weisberg and Melanie VanOverloop of Rapoport Law Offices PC.

GSK is represented by Alan S. Gilbert and Anders Wick of Dentons LLP, Chilton D. Varner, Andrew Bayman, Todd Davis and Heather Howard of King & Spalding LLP, and Robert Glanville, Thomas Wiswall, Tamar Halpern and Eva Canaan of Phillips Lytle LLP.

The case is Dolin v. Smithkline Beecham Corp. et al., case number 1:12-cv-06403, in the U.S. District Court for the Northern District of Illinois.

— Additional reporting by Emily Field, Kat Greene and Diana Novak Jones. Editing by Ben Guilfoy.

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.

Seroxat Addiction From 2003 (BBC)


A long, hard and painful process
Sarah Venn

Sarah Venn has suffered severe side effects

I remember, as a small child, feeling ‘wobbly’, as if I were on a boat, bobbing up and down.

I grew up with this feeling. By the time I was 16, various tests had confirmed that this sensation was not caused by an inner ear or balance problem.

As I grew older the wobbly feeling became worse and more problematic. After A-levels I started a law degree at Birmingham University and would travel from Coventry to Birmingham by train each day. As the wobbly sensation started to intensify, I worried that I would find myself overcome by it and stranded.

In November 1997, during my second year at University, the cause of the sensation was diagnosed as being Generalised Anxiety Disorder and my GP prescribed Seroxat to treat it. When I first started taking Seroxat I noticed no difference to the wobbly sensation, but felt detached from reality and became lethargic.

Dizzy

My legs were restless and constantly aching, I was nauseous and unable to keep food down

Sarah Venn

I would frequently experience ‘electric shocks’, which caused me to visibly jolt. The tiredness and detachment feeling affected my ability to study and travel to university, leading to the second year of my degree being postponed.

Six months into treatment there was a noticeable improvement to the wobbly sensation and I returned to university in September 1998. By Christmas 1998 the wobbly feeling bothered me on rare occasions. By now my weight had started to increase and I needed increasing amounts of sleep, but neither had become overly worrying.

In May 2000, just before I sat my degree finals, my GP decided it was time I came off Seroxat. I reduced from 20mg to nothing over a period of about two weeks.

As soon as I started to decrease, new feelings began: my legs were restless and constantly aching, I was nauseous and unable to keep food down, constantly dizzy, aching and feeling like I had the flu.

By the time I had finished reducing, I was too ill to leave my bed; I was exhausted and couldn’t see clearly, I needed help to get to the bathroom and feed myself. The GP put me back on 20mg of Seroxat and within days I recovered, just in time to sit final exams.

Suicidal thoughts

Sarah Venn

Sarah Venn in 1996

In August 2000, I moved to London to start work as a legal research assistant. That September, my father, who was on business in Singapore, telephoned me to tell me that he had just seen a newsflash about Seroxat.

I searched the Internet for more information and found many stories like mine. An article in the Guardian newspaper mentioned solicitor Mark Harvey and Dr David Healy.

I decided to see my GP about coming off Seroxat again. She recommended a more gradual tapering method and prescribed Seroxat liquid, which I measured out with a cup, cutting down 2-3mg each week. By the time I got near to 12mg, I was in physical and emotional turmoil.

The nausea had returned, along with flu-feelings, aches, blinding dizziness, exhaustion, rapid and painful successive electric shocks and depression. Most disturbing was the onset of suicidal thoughts and violent nightmares, in which I saw members of my family hurt. For weeks, I was unable to leave my bed. Friends would visit me with food parcels and cook for me.

I was studying the Bar Vocational Course at the time and trying to hold down part-time work. I was unable to do either. One night, in desperation, I called my father in tears, unable to carry on as I was. The next day he drove to London and took me to the GP, who put me on 30mg of Seroxat. After a few days at home, back on Seroxat, I had made nearly a full recovery.

Overwhelming

It has been a long, hard, painful process.

Sarah Venn

I went back to work and completed my studies. By June 2002, my weight had ballooned, and I was twice the weight at which I had started taking Seroxat. I was also requiring increasing amounts of sleep – sometimes 14 hours a night. I found it increasingly difficult to concentrate and was without energy.

Following consultation with medical staff and advisors from within my profession, I decided to postpone my career for a year to try and withdraw from Seroxat. Of particular concern were the long-term effects that Seroxat was having on my health, my weight having doubled, adding to the strain that SSRIs place on the heart.

It is now May 2003 and I am reducing from Seroxat using its liquid form and a syringe. It has been a long, hard, painful process.

I reached 16mg in the New Year, but the symptoms of withdrawal became overwhelming and unbearable and I had to increase my dose back to 20mg. I am still waiting to feel well again so that I can continue reducing, 1mg per fortnight.


Sarah is on the committee of the Seroxat Users Group.

The group was founded in the spring of 2002 by UK patients taking Seroxat to provide support to patients, their friends and families and has more than 5,000 members.

It offers support through meetings held regionally, a discussion forum and email contact with the committee members.

 

Paroxetine (Paxil/Seroxat) linked with increased risk of birth defects when taken in early pregnancy


http://www.thepharmaletter.com/article/paroxetine-linked-with-increased-risk-of-birth-defects-when-taken-in-early-pregnancy

05-01-2016

Using paroxetine – a drug prescribed to treat conditions including depression, obsessive-compulsive disorder, anxiety and posttraumatic stress disorder – during the first trimester of pregnancy may increase newborns’ risk of congenital malformations and cardiac malformations.

That’s the conclusion of a recent analysis published in the British Journal of Clinical Pharmacology. Paroxetine is the active ingredient of GlaxoSmithKline’s once blockbuster but now off-patent Paxil/Seroxat.

Up to one-fifth of women of childbearing age experience depressive symptoms that often lead to mild to moderate depression, and prescriptions for antidepressants during pregnancy have increased in recent years. The most common drugs for treating depression in pregnant women are selective serotonin reuptake inhibitors, and up until 2005, one drug in that class – paroxetine – was considered to be safe for use during pregnancy. A small unpublished study conducted by the manufacturer, however, suggested an increased risk of cardiac malformations in infants exposed to paroxetine before birth. Subsequent studies using various study designs in different populations across Europe and North America generated conflicting results in terms of statistical significance, although a trend remained towards an increased risk.

To provide a comprehensive assessment of the effects of paroxetine on newborns, a team led by Professor Anick Bérard of CHU Sainte-Justine and the University of Montreal, conducted a literature review and meta-analysis of all relevant studies published from 1966 to 2015. The investigators uncovered 23 eligible studies.

Results of meta-analysis

Compared with no use of paroxetine, first trimester use of paroxetine was associated with a 23% increased risk of any major congenital malformations and a 28% increased risk of major cardiac malformations in newborns. The investigators noted that the baseline risk of major malformations is 3% and of cardiac malformations is 1%; however, any increase in risk is significant, especially when considering that the benefit of using selective serotonin reuptake inhibitors during pregnancy – when changes in metabolism cause the drugs to be cleared from the body at a faster rate -is debatable.

“Given that the benefits of antidepressants overall, and selective serotonin reuptake inhibitors including paroxetine specifically, during pregnancy is questionable at best, any increase in risk – small or large – is too high,” said Prof Bérard, adding: “Indeed, the risk/benefit ratio suggests non-use in women with mild to moderately depressive symptoms, which is 85% of pregnant women with depressive symptoms. Therefore, planning of pregnancy is essential, and valid treatment options such as psychotherapy or exercise regimens are warranted in this special population.”

Paroxetne, Birth defects, Risk, Pregnancy, Meta-analysis, British Journal of Clinical Pharmacology

Inquest At Irish Woman (Anna Byrne) Seroxat Suicide Returns Open Verdict


http://www.independent.ie/irish-news/i-love-you-annas-last-words-28903436.html

‘I love you’ – Anna’s last words

Gareth Naughton

THE heartbroken husband of a pregnant woman, found dead at the bottom of a hill, has spoken of their last phonecall – when they both said they loved each other.

Anna Byrne (35) from Beechdale in Dunboyne, Co Meath, and her unborn twin sons were killed in the fall at Howth summit in the early hours of March 8 this year.

The mother of two’s last known contact was at 11am the previous day when she spoke on the phone with her husband, Terry Byrne, and told him that she was going to the supermarket, an inquest has heard.

“At the end of the call, I told her to phone anytime if there was anything,” he told the court. “We told each other that we loved each other and she said ‘I’ll see ya later'”.

Mr Byrne was giving evidence at Dublin City Coroner’s Court, where an open verdict was returned at the inquest into his wife’s death.

Missing

He first became aware she was missing at 1.30pm when she failed to pick up their son from Montessori school.

Mr Byrne checked the supermarket and maternity hospitals and rang her friends.

At 3.30pm, gardai in Dunboyne were notified. Just after midnight a friend found Mrs Byrne’s car at Howth summit. Gardai found a note in the car.

A search-and-rescue operation followed but was called off at 3.30am. At 7.49am, something was spotted at the base of the cliff and rescue workers where lowered down to recover the body.

It was established that Mrs Byrne had been dead for eight to 10 hours, and a post-mortem examination gave the cause of death as multiple injuries due to a fall from a height.

Mrs Byrne had been taking the anti-depressant Seroxat for 10 years but had stopped during her pregnancy.

Master of the Rotunda Hospital, Dr Sam Coulter-Smith, said that Mrs Byrne did not indicate a history of depression when she registered the pregnancy, but that this information was contained in notes relating to her previous pregnancies. Mental health team notes are not contained in obstetric team notes for confidentiality reasons, he said.

She was due to deliver by caesarean section on March 29, he said. In mid-February she was noted to be “anxious”.

Six days before her death, Mrs Byrne and her husband attended an appointment with consultant psychiatrist at the Rotunda, Dr John Sheehan. She told him that she felt “part of her life was missing” because she had no daughter.

“She said that she planned the current pregnancy hoping for a baby daughter but found out at 20 weeks she was having twins and that they were both boys. She said that she was devastated,” he said.

Her mood was low, particularly in the evening, and she described a loss of interest and not feeling “maternal”.

She told him she felt overwhelmed by the prospect of having four boys but did not express any intention to take her own life, he said.

Mrs Byrne’s GP had started her on Sertraline – an anti-depressant regularly used during pregnancy – and Dr Sheehan doubled her dosage, prescribed an anti-histamine to help her sleep and advised her to seek a referral to a counsellor in her area.

She was suffering a recurrence of depression associated with an adjustment disorder to her twin pregnancy of boys, he said. Mrs Byrne presented a low risk given that she did not indicate that she was suicidal and had made future plans, he told the court.

Speaking from the body of the court, her father John Deeney asked why she had not been admitted to hospital for observation on foot of her anxiety.

Dr Sheehan said this was only done in severe cases of mental illness and admission would be to a psychiatric hospital.

Coroner Dr Brian Farrell said the note was a farewell letter and “particularly heart rending” but it was not dated. He also noted the difficult terrain that Mrs Byrne would have traversed to get to the area where she fell and her lack of suicidal ideation.

He said that although he was not saying that Mrs Byrne did not take her own life, the evidence heard in court did not satisfy the legal test for a verdict of suicide.

He returned an open verdict.

Dr Farrell will also write to the board of the Rotunda Hospital reflecting Mr Byrne’s concerns about sharing of mental health notes with the obstetrics team in cases such as his wife’s.

Irish Independent

– See more at: http://www.independent.ie/irish-news/i-love-you-annas-last-words-28903436.html#sthash.tALPWVzr.dpuf

Brazil Suspends Sale Of Seroxat (Paxil)


From Seroxat Sufferers Blog:

http://fiddaman.blogspot.ie/2014/05/brazil-suspends-sale-of-gsks-paxil.html

Thursday, May 08, 2014

Brazil Suspends Sale of GSK’s Paxil (Seroxat)

The National Health Surveillance Agency (ANVISA) have temporarily suspended the sale of GlaxoSmithKline’s antidepressant Paxil.

ANVISA are the Brazilian drug regulatory agency who regulate the drugs Brazilian citizens are prescribed.

GlaxoSmithKline sent ANVISA correspondence stating that batches of Paxil may have been manufactured with the use of active ingredient in the presence of residues.

It’s unknown where the contaminated batches originated from. The batches recalled are:

SH0040V (manufacture date, June 2013, and expiration date, June 2015),
RK0084V (manufacture date, August 2012, and expiration date, August 2014),
RJ0220V (manufacture date, July 2012, and expiration date, July 2014),
RJ0219V (manufacture date of July 2012, and expiration date, July 2014),
RC0113V (manufacture date, March 2012, and expiration date, March 2014)
RC0113V1 (manufacture date, March 2012, and expiration date March 2014).

Last month GSK Ireland were sent a warning letter from the FDA listing a series of violations regarding the state of their plant in Currabinny, Carrigaline, Cork. Paxil had become contaminated with material from Glaxo’s waste tank, which contained APIs [Active Pharmaceutical Ingredients], intermediates, and solvents.

Back in 2010 Glaxo plead guilty for failing to meet government standards for their drugs that were being manufactured at their Cidra plant in Puerto Rico.

Bob Fiddaman

GlaxoSmithKline Ruins Lives : Seroxat Still Relevant 10 Years Later


GSK have a lot to answer for. They one of the most corrupt and despicable corporations  on the planet… 10 years later… hundreds of suicides, birth defects, and multiples of damages to consumers from the drug… and they still sell this Seroxat Crap to consumers… 

http://www.theguardian.com/uk/2003/aug/10/drugsandalcohol.jorevill

Robber cleared by drug defence

Charges dropped after report links Seroxat to threatening behaviour
, health editor
The Observer, Sunday 10 August 2003

A man arrested for armed robbery and theft has had charges against him dropped after medical experts concluded that his behaviour could have been altered by the severe withdrawal symptoms he was experiencing from the antidepressant Seroxat.Mark Douglas-Hamilton, who was facing a prison sentence for holding up a garage, was due to go on trial this week, but the case has been unexpectedly dropped by the Crown Prosecution Service.The CPS has not given any reason for its decision to discontinue, but it is believed that Douglas-Hamilton was helped by a medical report carried out for the defence which concluded that the drug could have contributed to his threatening behaviour.Campaigners against Seroxat, whose generic name is paroxetine, say they are aware of at least 10 other families who claim that their relatives committed acts of violence as they withdrew from the medication.

Their cases will be put later this month to the Government’s Medicines and Healthcare Products Regulatory Authority (MHRA), which is reviewing Seroxat.

The move comes as the Department of Health said last night it would examine the unlicensed sale of pre scription drugs on the internet following an Observer investigation today exposing the cybernet trade in such drugs, including Seroxat.

The drug’s manufacturer, GlaxoSmithKline, denies violence is a feature of withdrawing from Seroxat arguing that aggression is a feature of anxiety disorders.

However, Douglas-Hamilton’s account of how he suffered serious personality changes while trying to come off the pills has implications for other patients who also reported feeling extremely aggressive and reckless once they stopped taking the drug.

In November last year, two days after coming off the pills, Douglas-Hamilton, 30, used a pair of wire cutters to hold up a garage in Oxford where he walked away with a packet of cigarettes. A CCTV recording of the event shows his bizarre behaviour, where he joked with customers. Two weeks later, the theatre stage manager stole some CDs from a record shop. Douglas-Hamilton says he committed the acts, but claims his personality and behaviour were completely altered by the withdrawal effects of the drug.

‘I’m a fairly timid guy,’ he told The Observer last week. ‘I had only been prescribed [Seroxat] because I suffered from anxiety and some depression. It seemed to destroy my conscience and my fear. I found myself walking out of the house with knives; I had every intention of killing people.’

Douglas-Hamilton, who lives near Hereford, was due to face trial this week in Oxford on two charges of theft. But the case was unexpectedly dropped last Thursday by the CPS, which did not give a reason for the discontinuance .

Had the trial gone ahead, it could have proved a test case. Douglas-Hamilton would have pleaded not guilty, using a defence known as non-insane automatism. This argues that there is some external factor, in this case Seroxat, which was out of the defendant’s control, and caused him to behave irrationally. Dr David Taylor of the Maudsley Hospital had prepared a report for the defence, passed to the CPS, which concluded that the effects of Seroxat could have contributed to his behaviour.

The drug, which is prescribed to thousands of people every year for anxiety and depression, is already the subject of some controversy. Last year, SmithKline Beecham, which became GlaxoSmithKline, was successfully sued by Toby Tobin, after his father-in-law Donald Schell killed himself, his wife, his daughter and daughter-in-law in Wyoming, US. The company was ordered to pay £4.7million to the family. Schell had taken just two tablets before the murders, and had been depressed, but not suicidal, for the past 10 years.

There have also been claims from families in Britain that it has pushed relatives into suicide, and caused serious withdrawal symptoms. Sarah Venn, spokeswoman for the Seroxat Users’ Group, said: ‘I’m aware of at least 10 families whose children have committed criminal acts on withdrawal, and whose behaviour appears out of character. The MHRA needs to consider this as part of its review.’

A spokeswoman for GlaxoSmithKline said: ‘Violence and aggression are a feature of anxiety and depression disorders. Seroxat will reduce levels of these, and neither violence or aggression are withdrawal symptoms.’

In November last year, two days after coming off the pills, Douglas-Hamilton, 30, used a pair of wire cutters to hold up a garage in Oxford where he walked away with a packet of cigarettes. A CCTV recording of the event shows his bizarre behaviour, where he joked with customers. Two weeks later, the theatre stage manager stole some CDs from a record shop. Douglas-Hamilton says he committed the acts, but claims his personality and behaviour were completely altered by the withdrawal effects of the drug.

‘I’m a fairly timid guy,’ he told The Observer last week. ‘I had only been prescribed [Seroxat] because I suffered from anxiety and some depression. It seemed to destroy my conscience and my fear. I found myself walking out of the house with knives; I had every intention of killing people.’

Douglas-Hamilton, who lives near Hereford, was due to face trial this week in Oxford on two charges of theft. But the case was unexpectedly dropped last Thursday by the CPS, which did not give a reason for the discontinuance .

Had the trial gone ahead, it could have proved a test case. Douglas-Hamilton would have pleaded not guilty, using a defence known as non-insane automatism. This argues that there is some external factor, in this case Seroxat, which was out of the defendant’s control, and caused him to behave irra tionally. Dr David Taylor of the Maudsley Hospital had prepared a report for the defence, passed to the CPS, which concluded that the effects of Seroxat could have contributed to his behaviour.

The drug, which is prescribed to thousands of people every year for anxiety and depression, is already the subject of some controversy. Last year, Smith Kline Beecham, which became GlaxoSmithKline, was successfully sued by Toby Tobin, after his father-in-law Don ald Schell killed himself, his wife, his daughter and daughter-in-law in Wyoming, US. The company was ordered to pay £4.7million to the family. Schell had taken just two tablets before the murders, and had been depressed, but not suicidal, for the past 10 years.

There have also been claims from families in Britain that it has pushed relatives into suicide, and caused serious withdrawal symptoms. Sarah Venn, spokeswoman for the Seroxat Users’ Group, said: ‘I’m aware of at least 10 families whose children have committed criminal acts on withdrawal, and whose behaviour appears out of character. The MHRA needs to consider this as part of its review.’

A spokeswoman for GlaxoSmithKline said: ‘Violence and aggression are a feature of anxiety and depression disorders. Seroxat will reduce levels of these, and neither violence or aggression are withdrawal symptoms.’

Bob Fiddaman Examines GSK’s Seroxat and Birth Defects


http://fiddaman.blogspot.ie/2013/09/ssris-changes-to-labeling.html

Tuesday, September 03, 2013

SSRi’s – Changes to the Labeling

Former GSK employee Jane Nieman

I’ve just re-watched the Jane Nieman deposition that I uploaded to YouTube a couple of years ago.It’s a fascinating insight into how causality assessments come about…or not as was the case with GlaxoSmithKline regarding birth defects and their product Paxil.The audio is out of sync with the video but it still makes fascinating viewing.Something toward the end of the video grabbed my attention.There’s one question put to Nieman by the claimants lawyer.At 48.27 he asks Nieman, Do you know what a manufacturers duty is under the FDA when they make a determination that a drug is responsible for an adverse event, what their labeling duties are?Nieman does not answer.Lawyer then says “I can show it to you if you like”, he then reads the following to her:“Under the section heading the label shall describe serious adverse reactions and potential safety hazards, limitations in use imposed by them and steps that should be taken if they occur. The labeling shall be revised to include a warning as soon as there is reasonable evidence of an association of a serious hazard with the drug, a causal relationship need not have been proved.”
This particular blog post of mine is more of a reach out to consumers of pharmaceutical prescription products.Has anyone ever reported a serious adverse event to a pharmaceutical company and had a causality assessment returned that linked the product to the adverse event, if so, was the labeling changed as a direct result of that causality assessment?I know one case where a pharmaceutical company [Mylan] have not made any effort to change the labeling despite the assessment that their product was the probable cause of death. Do these rules, mentioned in the video, just apply to the FDA, what about other global medicine regulators?Be great if I could get some feedback on this either via email or my Facebook page.Meantime, here’s the video in question. I recommend watching it all but if you just want to skip to the labeling question then drag the cursor on the video to around the 48.27 mark.

Bob Fiddaman

 

Dr Peter Rost on Paxil/Seroxat : “Want To Kill Yourself”? (2006)


http://www.huffingtonpost.com/dr-peter-rost/want-to-kill-yourself_b_20880.html

Want to Kill Yourself?

The LAST thing you may want to do if you are young and want to kill yourself is to take a drug that will make you feel better. I’ll explain:

The antidepressant Paxil may raise the risk of suicidal behavior in young adults, GlaxoSmithKline and the Food and Drug Administration warned today in a letter to doctors.

An analysis of trial data from nearly 15,000 patients treated with both Paxil and placebo (dummy pills) revealed a higher frequency of suicidal behavior in young adults treated with the drug, according to the FDA letter. And if Paxil has this problem, it also means that other new antidepressants in the same class may have the same problem.

Clearly, antidepressants used under careful medical supervision are still likely to outweigh the risks, but the FDA letter highlights a serious issue. When doctors and patients find out about a problem with a new drug it may already be too late. The fact that a drug is approved for use doesn’t mean that it is safe. And once a drug is on the market it takes almost as much bad data to get the drug off the market as it took to get it approved in the first place.

But there are lots of early warning signs. Increased suicidal thoughts for young people on antidepressants have been discussed for years. And now the FDA has the data to say that this was actually true.

But your doctor can’t wait until the FDA has enough data. It is your life and your physician has to make sure that he doesn’t take unnecessary risks with your life. One way to do this is to not use a new drug right away, but wait, until there is good data demonstrating the drug is safe. Unfortunately, many cowboy docs have a problem waiting.

Only a week ago it was revealed that Vioxx — a drug which used to be very popular for the treatment of pain and inflammation — could cause heart attack within the first two weeks of use.

A quarter of patients who suffered a heart attack while taking Vioxx did so within the first two weeks of their first Vioxx prescription.

Is this conclusive proof that Vioxx actually killed after only a couple of weeks? Of course not, but it is an indication that the problem with Vioxx may be even worse than what was initially thought.

In medicine, “Primum non nocere,” applies today more than ever before: “First do no harm.”

(Vioxx was voluntarily withdrawn from the market by Merck on September 30, 2004 after a study showed that it doubled patients’ risk of heart attacks and strokes after 18 months of use.)

———————————————————————————–

Additional information just arrived from AHRP:

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
http://www.ahrp.org/cms/

A faith-based belief system masquerading as science is collapsing under the weight of evidence that has, for so long been denied by drug manufacturers, by the FDA, and by psychiatry: the best selling, most profitable antidepressants pose an increased risk of suicide for children and adolescents, for “young adults”–in fact, no age group is exempt. [1]

1. GlaxoSmithKline (GSK) has submitted documents to the FDA and other regulatory agencies, contradicting its decade long denial that its antidepressant drug, paroxetine (Paxil / Seroxat) increased the risk of suicidal behavior in the company’s controlled clinical trials,. http://www.gsk.com/media/paroxetine_adult.htm

2. In a letter to healthcare professionals this week, GSK warned about the increased suicide risk stating:
“There is a possibility of an increased risk of suicide related behavior in young adults ages 18-29” — whether the drug is prescribed for depression or for other conditions not associated with suicide. http://www.gsk.com/media/paroxetine/adult_hcp_letter.pdf

3.GSK is the first of the SSRI drug manufacturers to acknowledge in the Paxil label that the drug may trigger more than “suicidal thoughts.” The drug increases the risk of “suicide attempts.” The Paxil CR label now includes the following warning:

“young adults, are at an increased risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.”

GSK added warnings acknowledging that patients on the drug may experience “persistently worse” depression, or may “experience emergent suicidality or symptoms that might be precursors to worsening depression or suicidality” and “these symptoms” may be “severe, abrupt in onset, or were not part of the patient’s presenting symptoms.”

The company advises doctors: “”Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication.”

When was the link between SSRI antidepressants to suicide first reported?

In 1990 by Dr. Martin Teicher warned that Prozac (the first SSRI antidepressant) could cause suicidal behavior: “At the present time we recommend that this drug be used cautiously and that the practitioner be attentive to the possible emergence of suicidal ideation, even in those patients without a previous history of suicidal thoughts or actions.” [2]

In 1991 Dr. Robert King reported that the same phenomenon happens in children. [3] Yet, for more than a decade, drug companies indignantly denied any suggestion of such a risk, attacking those who were able to see the risk and dare to disagree.

In 1991, the FDA convened an advisory committee whose financial ties to Eli Lilly, allowed them to equivocate enough for the FDA to conclude “there is no credible evidence” that Prozac increases the risk of suicide… This imprimatur became the watchword of the industry and the new antidepressants skyrocketed to a $17 billion dollar market.

But the human casualties who had been prescribed Paxil and other SSRIs mounted, and in October, 2002, the BBC-Panorama aired an investigative report whose after-effects still reverberate on both sides of the Atlantic, as well as in Australia. BBC not only introduced the public to victims of irresponsible prescribing of the drug, and GSK’s drug marketing tactics, making visible the collision between patients’ physical and mental well-being and corporate marketing tactics, but the program laid bare the indifference of regulatory agency officials to a serious threat to public health safety.

In May, 2003, a BBC follow-up report provided the opportunity for two expert psychiatrists to express their opposing views publicly. Dr. David Healy, psychopharmacologist, medical historian, and Director, North Wales Department of Psychological Medicine, cited evidence of a suicide risk, and Dr. Alastair Benbow, GSK’s Head of European Psychiatry, defended the drug and denied the risk. [4]

Dr. Healy: “The evidence is that roughly one person in sixty that goes on this drug makes a suicide attempt. Now you have to contrast that with the people going on placebo or sugar pill, and the rate there is one person in five hundred and fifty. That’s nine or ten times less. The risk on the drug is nine or ten times greater than the risk on sugar pill.”

Dr. Benbow: “We have been asked by the regulatory authorities to provide all our information related to suicides and I can tell you the data that we provide to them clearly shows no link between Seroxat and an increased risk of suicide – no link.”

BBC reporter asked Dr. Benbow if he was “absolutely confident” that Dr. Healy is wrong on this issue and will be shown to be wrong?”

Dr. Benbow replied: “Yes, absolutely. Not only that but Doctor Healy has made the same claims about a range of other medicines. He made the same claims about Prozac… [repeats]…he made the same claims about a range of other SSRIs. On every occasion he has been found to be wrong.”

In September, 2004, Alan Metz, GSK North American medical director told the Wall Street Journal: “Each time it has been looked at, there is no suggestion of an association with suicidal tendencies in adults, with relation to SSRIs.”

For more than a decade, they claimed that depression causes suicide, not the drugs. Since then, the backtracking of the naysayers has taken on an almost comedic air. In 2004, they acknowledged “suicidality” in kids, but not suicide, and certainly not adults. Now, GSK admits the drug is associated with increased risk of suicide attempts in adults, but only in young adults. Well, okay, the fine print states “the higher frequency observed in the younger adult population may extend beyond the age of 24.” But “it is difficult to conclude a causal relationship.”

No it’s not difficult to conclude a causal relationship. This double speak is reminiscent of comedian Steve Martin’s admission to smoking marijuana:

“I used to smoke marijuana. But I’ll tell you something: I would only smoke it in the late evening….. Oh, occasionally the early evening, but usually the late evening – or the mid-evening…… Just the early evening, midevening and late evening. Occasionally, early afternoon, early midafternoon, or perhaps the late-midafternoon. Oh, sometimes the early-mid-late-early morning. . . . But never at dusk..”

This week’s GSK acknowledgements put to rest the hackneyed defenses: “it’s the disease not the drug” and “no evidence of a drug-induced suicide risk in adults.”

The simple truth is this: these drugs can cause violent suicidal behavior and death: in kids and in adults, in depressed people and in nondepressed people. The data do not demonstrate that any segment of the population is not susceptible to this risk.

Industry’s denials were buttressed by the FDA.

Daniel Troy, FDA’s former chief counsel, intervened in judicial procedures on behalf of drug companies by invoking FDA authority which he falsely claimed pre-empts state laws protecting public health safety. In a 2002 Amicus Curiae brief, Troy wrote: “…had Pfizer given a warning as to a causal relation between Zoloft and suicide, FDA would have disapproved the warning. Indeed, based on its current scientific knowledge, FDA would still do so today.” [5]

Then, senior FDA officials tried to suppress a report by FDA’s own safety officer, Dr. Andrew Mosholder, whose pediatric SSRI data analysis confirmed a twofold suicidal risk. [6]

Only under intense pressure (in 2004) from parents whose children became suicidal after an SSRI was prescribed; and only after Congress applied pressure on the FDA were warnings of suicidality added to these drugs’ label. However, complaints by drug companies led the FDA to weaken the warnings, removing the following sentence from the label: “A causal role for antidepressants in inducing suicidality has been established in paediatric patients.”

Even as black box warnings were being crafted senior FDA officials denied the existence of evidence the drugs increase the risk of suicide. Dr. Robert Temple testified before a Congressional committee: “At the time … it was not an issue that was prominent in our thinking,” Temple testified. “We had never seen a signal for suicidality in the adult data.” [7] And Dr. Thomas Laughren said his agency had a database of about 40,000 adult patients involved in clinical trials and that “so far, we have seen no signal” indicating the drugs might increase suicide risk.”

GSK’s public admission that in fact, in some cases, young adults (18-24) who take Paxil (paroxetine) are at increased risk of suicide, is based on clinical trial data that GSK and the FDA have been sitting on since the early 1990’s. This acknowledgement of the evidence contradicts its repeated pronouncements and contradicts the sworn congressional testimony of these FDA officials.

Despite the acknowledged suicide risk, GSK attempts to persuade physicians (in the letter to healthcare professionals) to continue to prescribe their drug, offering the company’s faith-based “belief” in the drug’s benefit: “GSK continues to believe that the overall risk-benefit of paroxetine in the treatment of patients with MDD and other non-depressive disorders remains positive…”

http://www.gsk.com/media/paroxetine/adult_hcp_letter.pdf

But here again, the evidence does not support GSK’s claim of SSRI drug efficacy. A meta-analysis of the clinical trial evidence from short and long-term clinical trials by Professor Irving Kirsch and colleagues, showed that 83% of the effect of these drugs is duplicated by placebo. [8]

The question is: Should drugs be approved and marketed on the basis of what the drug company believes, or what the evidence shows?

The pharmaceutical industry is regulated because drugs have the potential to cause serious harm, and industry, with its obvious financial conflict of interest cannot be relied upon to serve the public interest. This is the reason we have an FDA–its mission is to protect us from harmful drugs that companies may want to market. How has this regulatory system been working?

For 15 years the FDA has stood firm in support of drug companies even as they misinformed physicians and the public with false assurances about the safety of these drugs, claiming that there is no evidence of a drug-related risk of suicide. FDA’s policy allowed drug companies to market SSRI’s aggressively by flooding the media with deceptive advertisements. The drugs became blockbusters and companies raked in billions of dollars in sales. All the while, both the industry and the FDA covered their eyes and ears to the human tragedies and the rising number of drug-related casualties.

GSK now reluctantly acknowledges the evidence linking the risk of suicide to its antidepressant, evidence whose existence GSK had denied for so long. That evidence is not new. Dr. Teicher, Dr. King, and all the physicians and lay people who recognized the red flags about these drugs’ hazards, and were courageous enough to speak out, were right all along. And the FDA was wrong all along. Even today, the FDA has not acknowledged the lethal risk that GSK has finally admitted. The evidence has been in FDA’s files for years. Thus, its failure to warn to protect the lives of children and adults is either due to their incompetence or their complicity with drug manufacturers. Either way, their inaction is a dismal failure and betrayal of the public trust.

Earlier this month, the GAO issued a report about its investigation of the FDA, concluding that the FDA is broken and unable to fix itself. [9] The GAO suggested that new legislation is needed to correct the corruption at the current FDA that today is costing people their lives. This latest installment in the book of FDA failures confirms the GAO report. The only question now is whether congress cares more about public health or the financial interests of the pharmaceutical industry.

References:

1. Juurlink, DN, Mamdani, MM, Kopp, A, Redelmeier, DA. The Risk of Suicide With Selective Serotonin Reuptake Inhibitors in the Elderly, The American Journal of Psychiatry (May 2006).

2. Teicher, M. H., Glod C., & Cole J. O. (1990). Emergence of intense suicidal preoccupation during fluoxetine treatment. American Journal of Psychiatry, 147, 207-210. See also case report by Creaney, W, Murray, I, and Healy, D. Antidepressant Induced Suicidal Ideation, Human Psychopharmacology, 1991, Vol. 6:329-332.

3. King, R. A., Riddle, M. A., Chappell, P. B., Hardin, M. T., Anderson, G. M., & Lombroso, P. (1991). Emergence of self-destructive phenomena in children and adolescents during fluoxetine treatment. Journal of the American Academy of Child and Adolescent Psychiatry, 30, 171-176.

4. BBC Panorama: Postcards from the Edge, 5/11/03
5. Daniel E. Troy, Chief Counsel Food and Drug Administration Amicus Brief, September 3, 2002 ; See also: Gary Young, FDA legal strategy would pre-empt tort suits National Law Journal March, 2004, vol. 128; Pg. 3 ww.law.com/jsp/nlj/PubArticleNLJ.jsp?id=1076428430132
See also, http://www.ahrp.org/infomail/05/09/30.php

6. Dr. Mosholder’s embargoed report and the accompanying FDA memos are posted on the AHRP website at: http://www.ahrp.org/risks/SSRImosholder/index.php

7. Anne C. Mulkern, Panel hammers FDA on antidepressant issue Kids’ suicide risk cited, Denver Post, September 24, 2004.

8.Irving Kirsch, Alan Scoboria, Thomas J. Moore, Antidepressants and Placebos: Secrets, Revelations, and Unanswered Questions, Prevention & Treatment, Volume 5, Article 33, posted July 15, 2002 http://journals.apa.org/prevention/volume5/pre0050033r.html

9. GAO Report http://www.ahrp.org/cms/content/view/148/28/

Contact: Vera Hassner Sharav
212-595-8974
veracare@ahrp.org