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

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Nonetheless, the study has not been retracted or corrected, and “none of the authors have been disciplined,” Project Censored points out.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.


Just Another Paroxetine (Paxil/Seroxat) Death…

Prescription drug’s side effects contributed to woman’s sudden death

The Old Court House, Hatfield

The Old Court House, Hatfield

1 day ago / Matthew Lennon

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A woman left weakened by alcohol addiction and painkiller overuse died as a result of the side effect of an anti-depressant, an inquest heard.

Ann Marie Walsh, 46, was found in her Allum Lane home, in Borehamwood, by police on December 16 last year.

Concerns had been raised by her brother after he had been unable to contact her for a couple of days, and found that his key would not work in her front door.

After climbing a ladder and looking in through the first floor window, he saw a shape on the floor of the hallway.

He alerted police, and when officers broke in they found Ms Walsh showing no signs of life. She was confirmed dead at the scene.

An inquest at the Old Court House in Hatfield on Monday heard that having battled depression and anxiety for a number of years, Ms Walsh developed alcohol dependency as a result of work-related stress.

The inquest also heard she had a history of overuse of co-codamol and paracetamol.

She attended meetings at Spectrum Hertfordshire – a drug and alcohol recovery service – and was admitted to Watford General Hospital following an overdose of co-codamol in May 2015.

Two bags of anti-depressant drugs were found by a chair in her living room by police, however a post mortem found no traces of anti-depressants in her blood, according to Dr Mohamid.

It was concluded that, in the time before her death, Ms Walsh was taking the drugs purely for medicinal reasons.

Dr Mohamid told the inquest he believed Ms Walsh collapsed after experiencing a “sudden cardiac death”.

One of the anti-depressants she had been prescribed was Paroxetine, a known side effect of which is cardiac arrhythmia, more commonly known as an irregular heartbeat.

Deputy coroner Graham Danbury concluded that Ms Walsh died “as a result of a known side effect of a prescribed drug, contributed to by her impaired physical condition”.

Seroxat (Paxil): Explaining The Science…

It’s very easy to get confused when you read about the mechanisms of SSRI drugs, particularly when they involve clinical trial language and all the scientific jargon that comes with that. Dr David Healy’s recent post, on his blog, about Seroxat (Paroxetine) in youth was quite difficult for me to digest, however luckily Laurie Oakley explained it in quite simple terms.

Healy’s post was about the ‘continuation phase’ of a trial of Seroxat from GSK’s notorious 329 study.

According to Healy (in his post – see here):

“...All the fuss about Study 329 centers on its 8 week acute phase.

But this study had a 24 week Continuation Phase that has never been published.

Until Now…”

Laurie explains the post in simple terms, and also why it is so important in the story of Seroxat, she said:

“..Looks to me like the continuation phase didn’t produce a desirable outcome, even if they tweaked it, and seemed to result in negative information about the drug’s longer-term potential. In the absence of a positive outcome the study results were put away while the idea of long-term prescribing was promoted anyway.

JAACAP, who published and will not retract the acute phase of the study (which sucked but researchers portrayed the drug positively), will not publish the continuation phase of the study submitted by the RIAT team (a study which should have been paid attention to by the original reseachers and this is why it needed to be published)…”

It seems to me, that Seroxat has never been adequately studied for long term damage.If GSK’s own trial (illustrated above) shows harms in its 24 week continuation study- what harm is done after a year or more?

Effectively, those still ingesting it after, 5, 10, 15, or even 20 years- are GSK’s guinea pigs. I have seen the long term damage from SSRI’s, I have experienced medium term damage myself (I was on Seroxat almost 4 years), but who is studying these long term outcomes in the general population?

Thanks to Laurie for her input (for the quote).

See her video and book here-

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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?…

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

Inside the 11.9 Million Dollar Seroxat/Paxil Induced Suicide Case..

$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.

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

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