Tagged: SSRI

BMJ: US drug regulators should consider adding adults to SSRI suicide warning, says campaigner


http://www.bmj.com/content/357/bmj.j2050
News

US drug regulators should consider adding adults to SSRI suicide warning, says campaigner

BMJ 2017; 357 doi: https://doi.org/10.1136/bmj.j2050 (Published 25 April 2017) Cite this as: BMJ 2017;357:j2050

  1. Ed Silverman

Author affiliations

A British doctor who campaigned for the public to be warned about increased suicide risk in young people taking antidepressants has said that US drug regulators should consider including adults in warnings.

David Healy, a psychiatry professor at Bangor University, called for the warnings after GlaxoSmithKline (GSK) was ordered to pay $3m (£2.34m; €2.75m) to the widow of a US man who killed himself shortly after starting generic paroxetine.

The jury in the case of Stewart Dolin, a 57 year old attorney, concluded that GSK had failed to properly warn the public about the increased risk of suicide when taking paroxetine. The jury reached its verdict after lawyers for Dolin’s widow, Wendy, presented evidence in the Chicago federal court suggesting that GSK knew that paroxetine posed a risk to adults but had concealed or manipulated data.

Dolin stepped in front of a train in July 2010 shortly after starting a generic version of paroxetine that was sold by Mylan Pharmaceuticals. Mylan was originally named in the lawsuit but was later dismissed because of regulations and a Supreme Court ruling that a generic company cannot be sued if the brand name company does not first change product labelling.

Warnings about the increased risk of suicidal thoughts and behaviour in children and young adults were added to the labels of antidepressants in the US and Europe more than a decade ago.1 In the US, however, labels do not warn of these risks for anyone over 24 years old.

Many consumers have tried to hold drug makers responsible for suicides in adults without success. But the legal team representing Wendy Dolin argued that GSK had artificially inflated the number of suicides and suicide attempts that occurred among people who were given a placebo during clinical trials of paroxetine. They said that this alleged move made the antidepressant look better by comparison, since it appeared to minimise the risk of suicide associated with the drug.

The lawyers also argued that GSK had used averages for all selective serotonin reuptake inhibitors (SSRIs) to demonstrate that paroxetine did not raise the risk of suicide in adults aged over 24. Court documents also indicated that paroxetine displayed a much higher risk than all but one of the SSRI drugs.

Wendy Dolin declared the verdict “a great day for consumers.” After the verdict she told the Chicago Tribune, “This for me has not just been about the money. This has always been about awareness [of] a health issue, and the public has to be aware of this.”

Healy, who spearheaded the campaign to upgrade suicide warnings on antidepressants and testified as an expert witness on behalf of Wendy Dolin, said that the findings in the case should prompt the US drug regulator to review the evidence on SSRIs and suicide risk in adults.

“When it becomes so clear cut that a jury finds there is a problem, it suggests the evidence is strong enough to look at the issue,” Healy told The BMJ. “If it’s that clear to the average man on the street, and the FDA [the US Food and Drug Administration] doesn’t do something about it, we have an odd situation.”

GSK, which markets paroxetine under the brand name Paxil in the US, has said that it will appeal the verdict. “GSK maintains that because it did not manufacture or market the medicine ingested by Mr Dolin, it should not be liable,” it said in a statement. “Additionally, the Paxil label provided complete and adequate warnings during the time period relevant to this lawsuit.”

GSK added, “The scientific evidence does not establish that paroxetine causes suicide, suicide attempts, self-harm, or suicidal thinking in adult patients. In 2007, FDA revised the labelling for the entire class of SSRI drugs (including generic paroxetine and Paxil). The label includes statements that studies did not show an increased risk of suicidality (attempts or ideation) in adults over the age of 24, and that there appeared to be a protective effect in adults over 64.”

References

Glaxo’s Last Mudslinging Act At The Stewart Dolin Paxil Trial..


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“….Next came the issue of Rothschild’s cozy relationship with GlaxoSmithKline. In the Dolin case alone, Rothschild has been paid approximately $165,000 for his testimony.

Rapoport pressed Rothschild further and asked him about previous cases where GSK has called him as an “expert” witness.

When asked how many times GSK has hired him as a witness in Paxil death cases, Rothschild couldn’t seem to count that high. “Going back 15 years, I can’t give you an exact number, but it’s probably in the neighborhood of 20 or 30.”…”

-Bob Fiddaman:

http://fiddaman.blogspot.ie/


Two weeks ago, I decided to take a blog-break due to some health issues which I need to try to attend to. I still intend to pull back from blogging, as blogging about this stuff can be exhausting at times, however I feel It’s important to highlight the Stewart Dolin Paxil induced suicide trial currently ongoing in the US.

It seems to me that Glaxo’s case in defending Paxil, has been more of a masterclass in mudslinging as opposed to a legitimate defense of their drug. They seem to think that if they hire every pharma-whore they can find available and get those pharma-whores to sling mud at Stewart Dolin’s character, then that will be enough to sway the jury that it was not Paxil which caused Stewart to kill himself.

Pretty pathetic on Glaxo’s part, in my opinion.

Bob Fiddaman has been covering the Dolin trial on his blog for a few weeks, and his last two posts show just how desperate Glaxo are to deny that Paxil (seroxat) can cause suicide and akathisia.

It is simply astounding how GSK can try to defend Paxil/Seroxat in court on the premise that Paxil doesn’t cause suicide or akathisa, while at the same time, they admit in their PIL’s (Patient information leaflets) that Paxil can induce suicidal thoughts/ideation, akathsia and changes in behavior etc.

You can’t have it both ways, but it seems that isn’t going to stop Glaxo from trying.

One of Glaxo’s so called ‘experts’ in the Dolin trial is Dr Anthony Rothschild. Rothschild has apparently been defending GSK’s Paxil/Seroxat in possible Paxil induced suicide cases for many years.

I wonder how much money Dr Rothschild has made over the last 15 years defending Paxil? If he got over 150,00 dollars for one appearance, and he has done 20 to 30, for Glaxo, then perhaps defending Paxil alone has made him a millionaire?

You’d have to wonder too, does Dr Rothchild care about the wellbeing of those prescribed SSRI’s like Paxil?, does he care about the truth of the side effects of these drugs seeing the light of day? or does he care more about the hundreds of thousands of dollars he receives per court appearance from GlaxoSmithKline? and the monetary grants and honoria he receives from the drug industry?

I think astute readers will come to their own conclusions about that.

Seroxat/Paxil does cause Akathisia, I experienced it myself, and so have many others. Paxil/Seroxat does cause suicidal behaviors, I experienced this too, and so have many others. GSK are proven liars, fraudsters, felons and criminals. Anyone who takes blood money from them- to defend their drugs in cases where their drugs have caused harm- does not have the public’s best interest at heart.

Furthermore, greedy doctors on a drug company’s pay-roll certainly don’t have their patients’ interests at heart.

Dr Rothschild (and those of his ilk) make an absolute mockery of the medical Hippocratic oath..

“First do no harm”..

See Fid’s post here for more

 

Seroxat/Paxil Lawsuit Shows That Seroxat Increases Suicide Risk Over 800 Percent…


http://www.naturalblaze.com/2017/03/pivotal-lawsuit-shows-widely-used-antidepressant-increases-suicide-risk-over-800-percent.html

Pivotal Lawsuit Shows Widely Used Antidepressant Increases Suicide Risk Over 800 Percent

suicideBy Annabelle Bamforth

A trial is currently underway in Illinois as a widow seeks to hold pharmaceutical manufacturer GlaxoSmithKline accountable for improper labeling and minimizing a potentially serious side effect of a well-known antidepressant.

Paroxetine is a widely prescribed antidepressant and anti-anxiety drug under the class of drugs known as selective serotonin reuptake inhibitors (SSRIs). Paroxetine is most commonly known as the brand name of Paxil, manufactured by GlaxoSmithKline (GSK). 

Since 2012, Wendy Dolin has been engaged in a legal battle against GSK following the suicide of her husband, Stewart Dolin. Wendy says that in the summer of 2010, Stewart was prescribed a generic version of Paxil for anxiety issues related to work. According to Wendy, Stewart Dolin complained of becoming increasingly anxious and restless and was unable to sleep while taking the drug. On July 15, 2010, less than one week after beginning this medication, Stewart committed suicide by walking in front of a train.

Wendy began searching for answers in the wake of her husband’s suicide and said she learned that he had been displaying signs of akathisia, a disorder characterized by an individual’s inability to relax or sit still. Psychiatrist Joseph Glenmullen said in 2006 that “Patients have described [akathisia] to me as listening to nails scratching on a black board 24/7, or your bones rattling like tuning forks. It is this inner agitation that is by far the most dangerous.” In 2012, Wendy filed a legal complaint against GSK seeking to hold the manufacturer liable for her husband’s death. The complaint noted that “a scientist working for another SSRI manufacturer, Pfizer, wrote in a 1998 medical journal article that the suicidal impulses resulting from akathisia may be explained as a feeling that ‘death is a welcome result’ when the ‘acutely discomforting symptoms of akathisia are experienced on top of already distressing disorders.’”

The critical issue in Wendy Dolin’s lawsuit is not simply paroxetine itself. It’s no secret that lawsuits against pharmaceutical companies are usually complicated under most circumstances, but this case is particularly notable as a tragic example of the gray area of liability when a patient is prescribed a generic drug, as well as the problems between the FDA and drugmakers that exist when it comes to publishing safety labels for patients and doctors.

It’s important to distinguish that Stewart Dolin was not prescribed the brand of Paxil, but a generic brand of paroxetine that was manufactured by another company, Mylan. Brent Wisner, Wendy Dolin’s attorney, described the issue as a “donut hole of liability” in which both the generic and the original manufacturer deny responsibility. “That’s where you have the generic maker on one hand saying, ‘We don’t know about these risks. We can’t be held responsible for them… plus, we can’t change the label,’” Wisner said according to an NBC investigative report. Winner added that “the brand name makers are saying, ‘Well, we didn’t make the pill.’”

Generic drugs are often prescribed in place of specific brands, mainly to save costs, as generic drugs cost far less than brand names on average. In Illinois, where the Dolin family resided, “state pharmaceutical laws actually require such a substitution unless a doctor has advised against it. Some of the few courts that have sided with plaintiffs in generic-drug injury cases have also highlighted this conundrum for generic-drug plaintiffs,” according to a Law360 report on Wendy’s case.

Wendy and Wisner claim that the warning label that was given to the generic brand was “factually incorrect and misleading.” In their lawsuit, they allege that “the paroxetine label in existence at the time of Stewart Dolin’s death did not warn of the drug’s association with an increased risk of suicidal behavior in adults despite GSK’s knowledge of a statistically significant 6.7 times greater risk in adults of all ages. In fact, the label stated the opposite – that the suicidality risk did not extend beyond the age of 24.” Stewart Dolin was close to 57 when taking paroxetine.

The lawsuit alleges that GSK whitewashed the suicide risks of Paxil in its data given to the FDA. The complaint explains that in 1989, GSK”s “Integrated Summary of Safety Information,” required to gain approval from the FDA, included a presentation identifying the number of suicide and suicide attempts during clinical trials. The suit alleges that GSK’s summary “skewed the statistical analysis of the data presented and obscured the true risk” by including suicide attempts “of placebo patients that had taken place in the placebo run-in (or wash-out) phase” before the clinical trials began. “Run-in” or “wash-out” refers to a time period of removing any other drugs in a trial participant’s system; any “adverse events” that take place during those periods are not appropriate or generally accepted for inclusion in calculations during clinical trials, the suit claims.

The Cook County Record reports that while those warning labels on Paxil and paroxetine were approved by the FDA, GSK said it was not allowed by the FDA to include an additional warning of a “statistically significant increase in the frequency of suicidal behavior in patients treated with paroxetine.” GSK claims that the FDA wanted to maintain homogeneous warnings among all antidepressants.

However, U.S. District Judge James Zagel noted that GSK “never asked for a formal meeting, nor did it seek additional labeling regarding Paxil-specific data” in a February 2016 ruling, and further wrote that “Moreover, GSK never sent a separate supplement and declined the FDA’s invitation for a meeting to discuss the inclusion of … the adult warnings.”

The trial against GSK is in progress and is expected to last a few weeks. Bob Fiddaman, a blogger and author who has written extensively about his own experiences with paroxetine, has been covering the developments of the trial. Fiddaman wrote that a “startling revelation” was unveiled on March 22nd:

Attorneys representing widow Wendy Dolin showed the ratio of Paxil-induced suicidality in adults is a staggering 8.9.  It is not 6.7, as previously claimed and reported by Glaxo. The 6.7 figure is astoundingly high in itself, but the 8.9 ratio is flabbergasting!

Plaintiff witness, Dr. David Ross, said this figure is ‘astounding.’ What you should remember here is that GSK’s 1989 drug application for Paxil said the suicidality odds ratio was 2.6.

Fiddaman wrote that Dr. Ross, who worked for the FDA for ten years, offered lengthy testimony. Fiddaman points out that Dr. Ross discussed the problematic relationship between the FDA and drug manufacturers. The FDA relies heavily on the accuracy of the data that is provided by drug companies, which is problematic when the companies present arguable data.

GSK’s argument has summarily been that they do not bear liability because the drug that was prescribed to Stewart Dolin was not manufactured by Mylan, not GSK. The company has stated that “we remain consistent in our stance that since GSK did not manufacture or market the generic paroxetine ingested by Mr. Dolin, it should not be held liable in this trial.”

Annabelle Bamforth writes for TheFreeThoughtProject.com, where this article first appeared.

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.