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Nonetheless, the study has not been retracted or corrected, and “none of the authors have been disciplined,” Project Censored points out.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.
By FIONA MACRAE
Last updated at 00:02 07 March 2008Suicide: Jamie Hoole, who died aged 18 after taking Seroxat
Drug company bosses concealed information about the dangers of the anti-depressant Seroxat for five years while it was still being prescribed to children – yet they will escape prosecution over the cover-up.
Documents released yesterday as part of a four-year criminal investigation into GlaxoSmithKline show that the pharmaceutical giant had evidence that the drug didn’t work in children as early as 1998.
There were also suggestions the firm was aware of possible links to attempted suicides and suicidal thoughts.
But Glaxo did not alert Britain’s drugs’ watchdog to the problem until 2003, when the suicide link had become clear. The move led to an almost immediate ban on their use in under-18s.
Since it was first prescribed in Britain in 1990, the tablet, which makes GSK £1billion a year, has been associated with at least 50 suicides – both adult and child – in the UK alone.
Yesterday, the Medicines and Healthcare products Regulatory Agency hit out at Glaxo for withholding the information, and ministers promised to tighten the law.
But the watchdog came under fire itself over the failure to bring criminal proceedings against the firm for the cover up.
Ministers and officials insisted a prosecution was not realistically possible under the law as it stood at the time.
MHRA chief executive Professor Kent Woods said: “I remain concerned that GSK could and should have reported this information earlier than they did.
“All companies have a responsibility to patients and should report any adverse data signals to us as soon as they receive them.”
He said that although the law on disclosure of clinical data had been tightened in recent years, it would now be strengthened again.
In a letter to Glaxo, Professor Woods said: “Such a course of action should be unnecessary in an industry which relies so heavily on public trust and aspires to high ethical standards.
“I would have thought it self-evident that such information should be made available promptly to the regulator in order that action can be taken to public health.”
He added that Glaxo would not be prosecuted, as there was no realistic chance of a conviction under the legislation in place at the time.
However, the criticism may boost the case of British patients privately suing Glaxo after reacting badly when they tried to come off Seroxat.
Charles Medawar, of pharmaceutical watchdog Social Audit, said not just Glaxo but also the MHRA had “a great deal to apologise for”.
He said: “They say the decision not to prosecute was decided by the inadequacy of the law.
“My reaction is that before launching a million-pound investigation it might have been a good suggestion to check what the law actually says.”
Accusing the MHRA of a ‘naive and absurd’ level of trust in drug companies, he said: “The deviousness companies employ when promoting their drugs and minimising their side-effects is really quite extraordinary.”
Health Minister Dawn Primarolo said the Government would take “immediate steps” to strengthen the law, making it clear that drugs firms must disclose any information they had which could have a bearing on public health.
Glaxo denied it had withheld data, saying it “firmly believed” it had acted “properly and responsibly” and safety of its medicines was “paramount”.
It said there were no child suicides in any of the safety drug trials it carried out and it was only when the data from all nine trials was analysed together that any link with suicide emerged.
A spokesman added that Seroxat has never been licensed for use in under-18s in the UK and labelling stated that it was not recommended for children.
However, Seroxat, which is also known as paroxetine, was taken by an estimated 50,000 British children and teenagers before being banned for use in youngsters in 2003. Doctors are allowed to prescribe unlicensed drugs.
Prescribed to children as young as six, it was hailed by doctors as a “wonder drug”, capable of helping people overcome shyness.
However, it gradually became clear that the drug, which alters levels of mood-regulating chemicals in the brain, was not all it seemed.
As children taking it began to commit suicide, parents described how their sons and daughters suffered mood swings, nightmares and personality changes.
‘It was like giving him a loaded gun’
Jamie Hoole was just 18 when he was prescribed Seroxat for depression. Two months later, he killed himself.
His mother Jean Bambrough is convinced he would still be alive had it not been for Seroxat.
Miss Bambrough, 47, said: ‘It was like prescribing him a loaded gun.
“Jamie was depressed but I strongly believe he wouldn’t have done what he did if it wasn’t for Seroxat.”
The talented pianist and artist was given Seroxat after he lost his self-confidence and started to withdraw from everyday life. Initially, his depression seemed to lift.
Miss Bambrough, a personal assistant who split from Jamie’s father 20 years ago, said: “For the first few days, he was smiling and looked happy.
“But that didn’t last long. He became very agitated and couldn’t sleep. He was having really awful dreams.
“He couldn’t keep still and rocked backwards and forwards. He thought he was going mad.”
Jamie, a builder, then turned to self-harming, cutting his arms, legs and stomach with a knife.
Not long afterwards, his brother Daniel, then 13, came home from school to find him hanging from a belt in a bedroom of the family home in Northwood, North-West London.
An inquest into his death concluded it may have been “wholly or in part” linked to his use of the drug.
After the inquest in 2003 Miss Bambrough said: “All data on drugs should be made public before they are used on anyone – adults or children.”
Another Seroxat patient, Laura Davey, now in her 20s, was put on Seroxat because she was suffering from depression.
But instead of making her better the drug led to her self-harming.
She said: “As soon as I was put on Seroxat I started cutting myself every day. I was sitting in my bedroom with a compasses or a knife and I would slit my wrist so there would be blood.”
Read more: http://www.dailymail.co.uk/health/article-527837/Seroxat-makers-escape-prosecution-despite-failing-reveal-link-teenage-suicides-FOUR-years.html#ixzz2eVAC4AIl
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