A Decade of Questions Over a Paxil (Seroxat) Study Vindicated


http://bmcmedicine.biomedcentral.com/articles/10.1186/1741-7015-3-14

From 2005…

Writing in BMC Medicine, the team led by Dr Ivar Aursnes, said: “Patients and doctors should be warned that the increased suicidal activity observed in children and adolescents taking certain antidepressant drugs may well be present also in adults.

“We also conclude that the recommendation of restrictions in the use of paroxetine in children and adolescents conveyed by regulatory agencies lately should include usage in adults.”

Sophie Corlett, director of policy at the mental health charity Mind, said: “This study would seem to be an extremely worrying addition to growing evidence raising serious concerns over the safety of paroxetine.

“It confirms what Mind service users have long been telling us anecdotally.

“By ignoring what mental health service users themselves have said about the medication and its effects, the drugs regulators may well have caused lives to be lost.”

Paxil (Seroxat) is just as dangerous in over 18’s too..

http://news.bbc.co.uk/2/hi/health/4172482.stm

Drug suicide risk fears renewed

Seroxat (paroxetine)

The researchers looked at 1980s studies into Seroxat

Further concerns have been raised about potential suicidal side effects of a commonly used antidepressant.

The drug Seroxat (paroxetine) is already banned from use by adolescents because of an increased risk of suicidal thoughts.

In the journal BMC Medicine, University of Oslo scientists said existing studies indicated these warnings should be extended to adults.

GlaxoSmithKline, which makes the drug, said it had helped millions.

By ignoring what mental health service users themselves have said about the medication and its effects, the drugs regulators may well have caused lives to be lost
Sophie Corlett, Mind

Paroxetine is one in a class of drugs known as Selective Serotonin Re-uptake Inhibitors (SSRIs).

In 2003, around 19 million prescriptions for SSRIs were handed out in England for the treatment of depression and anxiety.

Concerns over suicidal side effects for those taking paroxetine were first raised by the BBC’s Panorama programme in 2002.

Last year the Medicines and Healthcare products Regulatory Agency’s (MHRA) Committee on Safety of Medicines concluded that a modest increase in the risk of suicidal thoughts and self-harm for SSRIs could not be ruled out, but the benefits for adults outweighed the risks.

Safety review

The Norwegian researchers, whose study was triggered by a journalist from the Norwegian Broadcasting Corporation working on a medical information programme, analysed the results of 16 trials involving the drug.

The studies were presented to drug regulatory agencies in 1989, prior to the drug being licensed for use by doctors in the early 1990s.

In each, patients had either been given paroxetine or a placebo (dummy pill).

The researchers carried out a statistical analysis of all the results, taking into account the length of time patients were on the drugs.

The studies included 916 patients on paroxetine and 550 patients on placebo.

There were no actual suicides in any of the studies. However, there were seven suicide attempts in the group on paroxetine, and only one in the placebo group.

Writing in BMC Medicine, the team led by Dr Ivar Aursnes, said: “Patients and doctors should be warned that the increased suicidal activity observed in children and adolescents taking certain antidepressant drugs may well be present also in adults.

“We also conclude that the recommendation of restrictions in the use of paroxetine in children and adolescents conveyed by regulatory agencies lately should include usage in adults.”

‘Confirmation’

A spokesman for GlaxoSmithKline: “We take the safety of all our medicines extremely seriously and will, of course, review this study carefully when it becomes available.”

He added: “At this stage, it’s not clear what method the researchers have used to arrive at these numbers or which clinical trials they have selected.

“However, we can say that these conclusions in no way reflect the picture that has been built up about the benefits and risks of paroxetine in adults through an extensive clinical trials programme involving 24,000 patients or through the use of this medicine in tens of millions of people around the world.”

An MHRA spokeswoman said it kept the safety of all SSRIs under close review and all new evidence was carefully reviewed and considered to see if new advice was needed.

Sophie Corlett, director of policy at the mental health charity Mind, said: “This study would seem to be an extremely worrying addition to growing evidence raising serious concerns over the safety of paroxetine.

“It confirms what Mind service users have long been telling us anecdotally.

“By ignoring what mental health service users themselves have said about the medication and its effects, the drugs regulators may well have caused lives to be lost.”

Margaret Edwards, of the mental health charity Sane, said: “Seventy per cent of those being treated with the new anti-depressants respond well, and the risks of suicide from untreated depression must be borne in mind in balancing the risks and benefits.”


http://www.counterpunch.org/2015/12/29/a-decade-of-questions-over-a-paxil-study-vindicated/

A Decade of Questions Over a Paxil Study Vindicated

bright-colored-pills

In the last few years, highly promoted drugs like Vioxx, Bextra, Baycol, Trovan, Meridia, Seldane, Hismanal, Darvon, Mylotarg, Lotronex, Propulsid, phenylpropanolamine (PPA), phenacetin, Raxar and Redux have been withdrawn for safety risks after millions used them. Sorry about that. Others like Avandia, Cylert, Ketek and Xarelto are under serious safety clouds.

But Big Pharma insists it is unaware of drugs’ true risks until a wide swath of the population uses them and “safety signals” emerge. Facts sometimes suggest otherwise.

In 1977, almost thirty years before Merck admitted its bone drug Fosamax caused jawbone death, its bone scientist observed the action in rats. (The “anti-fracture” drug also causes fractures.)

Years before the label of the antipsychotic Seroquel was changed in 2011 to warn the drug “should be avoided” in combination with at least 12 other medications because of heart risks, at least 99 articles in the U.S. National Library of Medicine linked the drug to “sudden death,”  “QT prolongation” (a heart disturbance that can lead to death), “cardiac arrest” and “death.” In many cases, the Pharma companies “discover” the problems after the drug patent has conveniently expired.

Then there’s Paxil. Paroxetine was a top selling SSRI antidepressant drug for GSK during the “happy pill” craze when Big Pharma was telling everyone they had “depression.” But in 2004, soon after its approval, the New York Attorney General charged that research about the drug published in the Journal of the American Academy of Child and Adolescent Psychiatry (known as “Study 329”) buried the drug’s true risks of suicide in adolescents.

And there were more questions about the research. Former Boston Globe reporter Alison Bass and others reported that the paper was not even written by the 22 doctors and researchers listed as “authors” but by a medical communication company hired by GSK. (Ghostwriting helped make Vioxx, Neurontin, hormone replacement therapy and even the flame retardant chemical deca [Deca-BDE] appear safe, according to published reports.) “You did a superb job with this,” wrote the Paxil paper’s first “author” Martin Keller of Brown University to Sally Laden, a ghostwriter working for Scientific Therapeutics Information. “It is excellent. Enclosed are rather minor changes from me.”

In 2006, “author” Martin Keller, former Professor Emeritus of Psychiatry at Brown, acknowledged that GSK had given him tens of thousands of dollars during and after the time the study was conducted.

There were also questions about where the research appeared. The Journal of the American Academy of Child and Adolescent Psychiatry is a publication of the American Academy of Child and Adolescent Psychiatry which lists the funders of its “treatment guidelines” for children and adolescents with bipolar disorder as Abbott, AstraZeneca, Eli Lilly, Forest, Janssen, Novartis and Pfizer.

Almost fifteen years after the questionable research was published, the furor had not died down. In 2014, two members of the American Academy of Child and Adolescent Psychiatry, Edmund Levin and George Stewart, asked the editor of the Academy’s journal why the discredited paper was still standing and had not been retracted. (A quick look at other scientific papers identified in the press as ghostwritten shows that few are retracted and most are standing, to deceive future generations.)

Then, in September 2015, when many reporters, psychiatrists, researchers and professors had given up the Paxil fight, the British Medical Journal (BMJ) published a reanalysis that amounted to a reversal of the original study. The new research demonstrated that Paxil indeed increases risks of suicide in young people and adolescents.

The reanalysis of Paxil’s suicide risks in the young is a victory for safety activists, medical reporters, the public and freedom of the press. But many pro-pill doctors continue to fight evidence of Paxil’s suicide risks and similar SSRIs. “There is a very reasonable possibility that it has discouraged patients from taking antidepressants and physicians from prescribing these medications [and] the government should rescind the black-box warning on antidepressants altogether,” Richard A. Friedman, a professor of clinical psychiatry at Weill Cornell Medical wrote in the New York Times a month before the Paxil reanalysis.

Martha Rosenberg is an investigative health reporter. She is the author of  Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health (Prometheus).

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2 comments

  1. kiwi

    I wonder what ties Richard A. Friedman, has to pharma?
    I think he would have learned a whole heap more if he had have tried some of his own medicine instead of his Transcendental Meditation for the past three years.
    “As of 2014, Friedman’s research activity is in the field of chronic depression: evaluating antidepressant medications;” ….well i guess there is the answer right there………..pharma funded no doubt.
    As i say why not evaluate these shiny red apples by trying some for yourself Mr Friedman.

  2. Pingback: 2016… | seroxat secrets...

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