There has been so much written, blogged and filmed, about Seroxat, in the past 15 years that often I find the most insightful comment gets lost amongst the Seroxat noise on the internet. Therefore, I thought it might be useful for my readers if I was to compile what I think to be some very important and definitive statements from what is out there about Seroxat. It is quite amazing that the first article comes from 2003, that’s over 7 years ago now, the coroner here had grave concerns that Seroxat causes suicide and should be withdrawn from sale, yet the regulator does nothing. Note : Statements/quotes in bold..
‘Coroner calls for drug to be withdrawn’
The world’s best-selling anti-depressant should be withdrawn from sale in the UK, a coroner said yesterday after linking the drug to the death of a retired Welsh teacher.
Geraint Williams added his voice to a growing body of health experts concerned about a link between Seroxat and suicide after hearing how Colin Whitfield killed himself just two weeks after starting a course of the drug.
Mr Williams will now call on the Department of Health to undertake an urgent inquiry into the controversial anti-depressant, which is manufactured by GlaxoSmithKline and prescribed to millions of people around the world.
Speaking at the inquest into the death of 56-year-old Mr Whitfield, the Brecon coroner said, “I have grave concerns that this is a dangerous drug that should be withdrawn until at least detailed national studies are undertaken.
‘Sharise had so much talent and energy, Seroxat took that all that away’
This web site is dedicated to my late sister Sharise Gatchell.
Sharise committed suicide on the 25th May 2003…age 18… Sharise had been prescribed the anti-depressant Seroxat, also known as Paxil in the U.S.
I really thought she would become a famous artist.. Sharise had so much talent and energy, Seroxat took that all that away… after only 17 days on Seroxat, she hanged herself from the loft hatch in my parents home…
My mom and dad found her on their return from a weekend trip in Scotland… Sharise knew very well that my parents would not let her go back on Seroxat and so she took it secretly. The first time she was prescribed the drug at the age of 16, she started self harming, cutting her arms, something that had never ever happened before. She was never the same again.
2 years later Sharise felt really down and in desperation went to see a GP. Unwittingly a new doctor prescribed my sister Seroxat again. The previous doctor never bothered to add to the medical records that Seroxat had caused Sharise to self harm, even after my mother made a great deal of effort to make her aware of the issue.
The drugs manufacturer GlaxoSmithKline has finally admitted that Seroxat can cause some people to have suicidal thoughts and tendencies when on the drug.. Thanks for letting us know 2 weeks after her death. Congratulations for raking in billions of pounds while you poison our society with your wicked “treatments” that are now turning out to be less beneficial than a placebo. I wish immense stress and bankruptcy on all of you.
My family and I will spend the rest of our days making people aware of the enormity of your greed, and your selfish disregard for human life… we shall NEVER stop…
‘The only thing that had changed was the medicine he was taking, the Paxil [the US brand name for Seroxat’]
Donald Schell had been on Paxil for just two days and taken just two tablets before his killing spree. He had been depressed, but not suicidal, for the previous ten years.
Others who went on the drug ended up more restless, in a state of mental turmoil, complaining about dreams, nightmares
Dr David Healy
During the case, one man was allowed access to the GlaxoSmithKline archives in Harlow, that man was Dr David Healy.
He spent two days wading through more than 250,000 documents in the confidential archive for some reports on the clinical trials for Seroxat.
When he eventually found the right files, it didn’t take him long to come to a conclusion.
“It seemed clear that some people that went on the drugs had no major problems, but equally clear that others who went on the drug ended up more restless, in a state of mental turmoil, complaining about dreams, nightmares and a range of things like this. These don’t seem to have been explored further in any great detail.”
He discovered around one in four of the healthy volunteers suffered this sort of mental turmoil on Seroxat – even when they were on normal doses and even when they’d only been taking it for a few days.
His conclusion was not accepted by the company, but it was accepted by the jury who found GlaxoSmithKline to be negligent and awarded more than $6m (£3.8m) in compensation.
‘Why I resigned over ‘happy pill’ cover-up’
WHY RICHARD BROOK RESIGNED
Why I resigned over ‘happy pill’ cover-up by RICHARD BROOK, Daily Mail 09:36am 23rd March 2004
Last week I resigned from the Government’s watchdog on anti-depressants after it tried to cover up its own ten-year failure to identify serious side-effects of the controversial drug Seroxat.
The Medicines and Healthcare Products Regulation Agency found from information that had been in its possession for more than a decade that high doses of the anti-depressant can lead to aggression and thoughts of suicide.
But instead of revealing the truth to the 17,000 people taking high doses and the other half-million Britons on a safer dose, the MHRA sat on its findings.
Astonishingly, I was actually threatened with legal action by Professor Kent Woods, chief executive of the MHRA, if I revealed this.
Mind, the mental health charity, has been tracking Seroxat for a decade and found it to be the most problematic anti-depressant. Side-effects include nervousness, aggression, irrational thoughts and, in some cases, feelings of suicide.
Although Seroxat has been effective for thousands suffering from severe depression, there are many who blame tragic events, including murders and suicide, on it. Last year, BBC’s Panorama showed that – despite denials from the manufacturer – people can get hooked on Seroxat and suffer terrible withdrawal symptoms when trying to come off it.
‘Not suicide, just plain murder’
Not suicide, just plain murder
Drug giant GSK covered up data from trials of its anti-depressant Seroxat which showed increased risk of suicidality among child patients and failed to demonstrate effectiveness, instead promoting the drug as ‘safe and effective’. Basil Miller reports on Panorama’s coverage
Secret e-mails show that one of the world’s biggest drug companies distorted clinical trial results of their anti-depressant Seroxat, covering up a link with suicide in teenagers. On Monday January 29, the BBC TV programme Panorama showed shocking footage demonstrating how GlaxoSmithKline’s PR people and marketing department ‘spun’ devastating trial results on children which showed serious risk of suicide, self-harm and aggression (violence), and also indicated it was no more effective than a sugar pill. Instead they claimed to doctors that the drug was ‘remarkably’ safe and effective for under-18s, with the support of an ‘independent’ professor of psychiatry who earned $500,000 in fees from drug companies in one year.
Seroxat, marketed in the US as Paxil, an SSRI anti-depressant whose active ingredient is paroxetine, was a big success for GlaxoSmithKline (GSK) from its release in the 1990s, earning billions of dollars worldwide for the drug giant. With a strategy of creating new markets for the drug, in the mid-1990s GSK began to explore the possibility of obtaining a licence for its use in children (under-18s), and conducted clinical trials on groups of children to provide data proving its effectiveness which would support its application.
However, the trials were a bust, in particular Study 329, the biggest of a series carried out over a period of years in the US. The results of Study 329 demonstrated that Seroxat had no measurable benefit to child patients. As is usual in the so-called gold standard clinical trial approach, the drug was tested on one group while another was administered a placebo, a sugar pill with no active ingredient. Neither group, nor the administrators of the pills, knew which pill they were getting.
The group given the placebo performed just as well, or as badly, as those given Seroxat in terms of the trial designers’ criteria for improvement in their depression.
But the children who were given Seroxat suffered adverse reactions ranging from mild to serious. The serious adverse reactions included self-harm — mostly cutting; aggression — violence to others; and suicidality — suicidal thoughts or actions, meaning actual suicide attempts.
Seven out of the 93 children in the Seroxat group had to be hospitalised as a result. That’s almost eight per cent. To independent researchers, that would be a wildly unacceptable proportion of a treatment population.
In terms of risk, for example, a prevalence of an adverse drug reaction of one in one hundred, one per cent, or more is defined as ‘frequent’ and seen as unacceptable.
Yet Seroxat had put eight in one hundred in hospital in this clinical trial.
“This was the point at which GSK should have begun warning physicians who were prescribing the drug to children because not only is it not effective, it’s not safe,” says Karen Barth Menzies, the California lawyer heading the team pursuing a giant class action suit against GSK in America. Menzies possesses previously secret internal memos and e-mails from GSK, obtained as part of the disclosure process for the upcoming trial, which show what actually happened next.
The company dropped the plan to apply for a licence for the use of Seroxat in children. Its executives immediately recognised that the results of Study 329, which demonstrated no efficacy in treating adolescent depression, would ensure that no licence would be granted. In an internal company memo dated 14 October 1998, they concluded that the drug does not work and that a licence application would be refused: ‘The results of the study were disappointing. The possibility of obtaining a safety statement was considered, but rejected.’ The best they felt they could achieve was a ‘ statement that although safety data was reassuring, efficacy had not been demonstrated’.
‘Efficacy had not been demonstrated’ is a fancy way of saying that the drug did not work, and they knew it. ‘The possibility of obtaining a safety statement was considered, but rejected’ means they realised that the extent of adverse reactions in the trial, at 8%, meant the drug was not safe.
GSK marketing teams commented that ‘the data would be unacceptable commercially’. Panorama’s reporter Shelley Jofre translates this as ‘publishing the data in full would put profits at risk’.
Enter the spin doctors.
So the self-harm, aggression and suicide attempts were kept quiet, the lack of effectiveness filed away. PR people took over to implement a new plan: promote Seroxat to doctors as a treatment for under-18s.
How could this be? If it’s not been granted a licence, how can a drug be prescribed? Unfortunately, as Panorama explained, even if a drug is not licensed for a particular group doctors can still prescribe it if they think it will benefit their patient — so-called ‘off-label’ prescribing.
So GSK’s plan was simple — persuade doctors that Seroxat was indeed suitable for their child patients. Which they duly put into effect, spinning the exact opposite of what the studies had shown: Seroxat, they said, was ‘remarkably effective and safe for children’.
Enter the academic psychiatrists, notably Professor Martin Keller of America’s Brown University and child psychiatrist Dr Neal Ryan of the University of Pittsburgh, both co-authors of Study 329.
Panorama questions whether Keller is independent in any sense. The programme pointed out that in one year he earned $500,000 in fees from drug companies including GSK. Worse, it demonstrates that his paper on Study 329, published in the Journal of the American Academy of Child and Adolescent Psychiatry, which says it ranks as number one in child mental health in the world, ‘was written by a ghost writer who worked for a PR company, a PR company hired by GSK’. And it quoted an e-mail from Keller to the ghost writer, thanking him for his work: ‘You did a superb job with this. Thank you very much. It is excellent. Enclosed are some rather minor changes from me…’
The ghost had even penned Keller’s covering letter submitting the paper to medical journals.
Child psychiatrist Neal Ryan was paid by GSK as a co-author of Study 329. In 2002 he gave a talk on childhood depression at a medical conference in Toronto sponsored by GSK, attended by 15,000 psychiatrists. He said that Seroxat could be a suitable treatment for children and later told Shelley Jofre that it probably lowered rather than raised suicide rates.
And among the archive of documents in the lawyers’ possession, Jofre found the evidence that Ryan had forwarded to GSK her own e-mails to him from 2002 asking questions about the safety of Seroxat. His covering e-mail asked the company for advice on how to respond to her queries.
Nonetheless, the paper, of which Keller and Ryan claimed authorship, was published — but not before one journal turned it down after its peer reviewers found serious flaws, notably the downplaying of adverse reactions to Seroxat among the children trialed.
Last year, Professor Keller admitted to lawyers suing GSK that he had not studied the results of Study 329 in full. “I reviewed data analytic tables. I don’t recall how raw it [the data] was. [These are] huge printouts, you know, item by item numbers and variable numbers, and don’t even have words on them. I tend not to look at those… I do better with words than I do with symbols,” he recounted in a session recorded on video. In effect, he admitted that his ‘authorship’ of the paper, apart from being written by a PR company’s ghost, was based on at best an inadequate and incomplete scrutiny of the data — hardly the gold standard scientific review we are constantly told validates clinical trials.
Says Karen Barth Menzies: “These academics are truly spokespersons for the drug companies.”
But the drug company in question, GlaxoSmithKline, buried the trial data, including data from another, later trial on children which found that the placebos given to the control group of depressed kids ‘worked’ better than Seroxat. And later, forced by US medicines regulator the FDA to re-evaluate the raw data from Study 329, the company admitted to four further adverse reactions in which children became suicidal, raising the number suffering severe reactions to the drug from seven to 11 — a shocking 12 per cent of the total, and representing a 600% increase in events related to suicide.
Memos in the lawyers’ boxes of GSK papers show that company executives clearly told the PR woman who designed their spin strategy that ‘Seroxat may have caused all of these’. Yet the final article, approved by the PR, stated: ‘Of the 11 patients, only headache (one patient) was considered to be related to the treatment’ and concluded that the drug was ‘generally well tolerated and effective’. This was, finally, reviewed by and accepted for publication in the Journal of the American Academy of Child and Adolescent Psychiatry. And it was published relatively unchanged, even though the journal’s peer reviewers objected in these terms: ‘Overall, results do not clearly indicate efficacy. Authors need to clearly note this.’ ‘The relatively high rate of adverse effects was not addressed in the discussion (core portion of an academic paper)’ ‘Given the high placebo response rate, are these drugs an acceptable first-line therapy for depressed teenagers?’
Though the article appeared, GSK abandoned a part of its PR plan which intended to use it extensively in publicising Seroxat’s use with children. At company headquarters in Britain, a PR executive commented: ‘Originally we had planned to do extensive media relations surrounding this study until we actually viewed the results. Essentially, the study did not show [Seroxat] was effective in treating adolescent depression, which is not something we want to publicise.’
After publication, the third of GSK’s trials reported that the placebo worked better than Seroxat. The company’s public claims had been flatly contradicted by its own trial, but it maintained a deafening silence on this, telling doctors instead that Study 329 showed the drug ‘was superior to placebo by several assessment methods’. The two failed studies were not mentioned either when GSK informed its US sales force that Seroxat/Paxil ‘demonstrates remarkable efficacy and safety in the treatment of adolescent depression’.
“They didn’t tell the regulators or physicians or parents about these risks or the lack of efficacy. Instead, they went out and promoted this specific study as remarkably effective and safe for kids,” says Menzies. “That’s a lie. A fraud.”
GSK told Panorama: “GSK utterly rejects any suggestion that it has improperly withheld drug trial information.” Here in Ireland, in response to questions from journalists at Newstalk106, GSK sang the same song: “GSK Ireland takes very seriously the allegations that Seroxat was promoted for an indication for which it is not licensed. We strongly refute any suggestion that Seroxat may have been promoted to Irish doctors for use outside of the strict terms of its licence. Seroxat is not and never has been, authorised to treat major depressive disorder in patients under the age of 18. Furthermore, Seroxat has never been promoted for use in the treatment of depression in children or adolescents and GSK Ireland medical representatives were never trained to promote Seroxat in this manner in Ireland. GSK utterly rejects any suggestion that it has improperly withheld or altered drug trial information. Results from its paediatrics studies were documented and submitted to regulators in accordance with regulatory requirements. Results were also presented publicly, published in scientific journals and are available on GSK’s website.”
This, of course, does not answer Panorama’s allegations at all. The programme made no reference to what GSK may or may not do to promote its dangerous product in Ireland, nor did it allege that GSK had withheld trial data it was obliged to give to regulators. What it did allege, and demonstrate to be true, was this — that GSK initially planned to apply for a licence in the USA for the use of Seroxat in the under-18 population, which was Plan A; and that when the trial data showed Seroxat was unsafe and ineffective for under-18s, GSK dropped the licence application and switched to Plan B, which was to promote the drug to doctors for off-label prescribing. Once having dropped the plan to get a licence, GSK was under no legal obligation to provide regulators with the data. Obviously, there’s no point in talking of any moral obligation.
And Panorama clearly demonstrated that GSK lied in implementing Plan B.
Here’s what their marketing people concluded after analysing the unpublished trial data: “The results of the studies were disappointing. The possibility of obtaining a safety statement from this data was considered but rejected.” And here’s what GSK told their sales reps: “[Paxil/Seroxat] demonstrates remarkable efficacy and safety in the treatment of adolescent depression.”
And GSK went ahead and promoted the drug for children.
Dr David Healy, Professor of Psychiatry at the University of North Wales, is angry that doctors have been deceived into prescribing a harmful drug. He says: “The experts all said that it was extremely safe and very effective. We were all hoodwinked. Misled. Duped. They [GSK] produced these clinical trials which appeared to be evidence. And they aren’t: they’re adverts.”
In June 2003 Britain’s Medicine and Healthcare Products Regulatory Authority (MHRA) advised that Seroxat should not be given to anyone under 18 because its analysis had shown that GSK’s own studies demonstrated that the drug actually trebles the risk of suicidal thoughts and behaviour in depressed children.
But this came too late for Charise Gatchell, who watched the programme with her parents — who did not know she was secretly taking Seroxat again, having come off it following serious adverse effects, including cutting herself and suicidal thoughts, during a previous prescription. Short weeks later, her mother found the 16-year-old’s warm body hanging on the upstairs landing when she and her husband returned from a weekend away. Says Stephanie Gatchell: “The decision-makers in that company should be brought to justice. They have a lot to explain. They just kept on denying and denying and denying, so a programme like Panorama virtually had to force them to admit… were they ever going to come out with the truth on their own? I don’t think so.”
Says David Healy: “People who are ill have been deeply betrayed by the whole process. They have been betrayed by the pharmaceutical companies and by all the experts who have been willing to lend their names to the process.”
In the US, bereaved families have joined together to sue GSK. The Panorama programme closes with a sequence of some of the children who killed themselves after being prescribed Seroxat. Of the last child, Karen Barth Menzies says: “This is a little boy who was 11 years old. He started taking Seroxat and he ended up… he hanged himself in the closet… with the leash of his new pet puppy.”
This isn’t suicide; this is murder.
Dublin, Ireland: 1 February 2007