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Nonetheless, the study has not been retracted or corrected, and “none of the authors have been disciplined,” Project Censored points out.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.
Note : All information is provided with a link to source ( you might have to copy and paste it into your web browser to access the original information)
As we can see from the previous links, where Seroxat came from, how it was marketed and how it was sold and how it was released for public consumption…
Also from link 6, we can see that Marty Keller, Sally Laden, James MacCafferty and Neal Ryan all played a part in Study 329 , Glaxo’s dubious and ultimately flawed Seroxat Child study…
The result of which meant that Seroxat/Paxil was pushed on children , many of whom harmed themselves and committed suicide because of its promotion…
In the UK however, We think that the most important players to focus on in order to try to understand the Seroxat Scandal and how it came into being are the MHRA…
The MHRA is the UK’s equivalent of the FDA in America…
The organisation itself is in charge of drug regulation…
The BBC’s Panorama have done 4 exposes on Seroxat and some of it has touched on the failure of the MHRA in regard to Seroxat …
Who are the Seroxat Players in the MHRA…?
Namely they are Alasdair Breckenridge and Ian hudson…
Ian Hudson and Sir Alasdair Breckenridge were both once high level employees of GSK and now work for the MHRA ( the UK equivalent of the FDA) ..
Alasdair Breckenridge : “We must not get hung up on safety but instead must focus on risk-benefit”
When asked by Panorama whether GSK had acted promptly in getting the information about Seroxat’s use in children to the regulator, the MHRA’s chairman, Sir Alasdair Breckenridge, says: “This is a matter which we are investigating at the present time.
In a letter to Professor Sir Alistair Breckenridge in January, Dr John Patterson, the ABPI president, wrote: “We remain concerned at the lack of representation of the pharmaceutical industry at board level within the MHRA … As the only regulatory agency that is fully industry-funded, we believe it is essential that we have a say on a variety of issues, not least financial matters relating to fees and service levels.”
I would be obliged if you would bring our concerns to the government
regarding the MHRA, and in particular the recommendation that they should
not be as close to the pharmaceutical industry. Please do also ask the
government to explain why they continue to allow the MHRA to be funded by
industry rather than from general taxation. Clearly by allowing the MHRA to be
funded 100% by the pharmaceutical industry the government have allowed the
system of drug regulation to become corrupt!
Please read the following excerpt from a transcript of the Health Select
Committee Investigation of the Pharmaceutical Industry Influence where Dr
Ian Hudson Director of Licensing for the MHRA had been called to give
evidence but failed to appear:
Q783: John Austin – I also note that we do not have Dr Ian Hudson with us
this morning, although he was listed as one of the witnesses. Is there any
reason why not?
Professor Sir Alasdair Breckenridge: Yes, Dr Hudson is one of our delegates at
the CHMP, the Committee on Human Medical Products at the EMEA and he is
there today. He is fulfilling a different role for the agency down there
- The Infamous Shell Murder Trial in which Paxil was found to blame as the cause for murder :
Glaxo’s representative in court, Ian Hudson, who now works for the Medicines Control Agency in the UK, argued that the occasional suicide or killing by somebody on Paxil is not sufficient evidence that there is a problem with the drug, considering the millions who take it.
The chief executive of Mind, the mental health charity, last night resigned from a high profile review of modern antidepressant drugs, accusing the British medicines regulatory body of negligence.
Richard Brook had a unique position as a lay member of the expert working group on the class of antidepressants which includes Seroxat and Prozac.
His resignation came in protest at what he considered a cover-up by the regulators, after months of pressure on him not to reveal the review’s findings that Seroxat has for years been prescribed by doctors in an unsafe dose and that the regulators had the evidence in their possession for more than 10 years.
Mr Brook’s resignation sheds a rare light on the workings of the secretive drug regulation agency and its advisers, and will heighten public concern over their relationships with the pharmaceutical manufacturers.
Dr Ian Hudson is a physician who has practiced as a paediatrician for a number of years. He was formerly a research fellow at the University of Glasgow. He joined SmithKline Beecham in 1989 where he held various appointments in clinical research and development. He joined the MCA (Medicines Control Agency) in January 2001 as Director of the Licensing Division. He is the CHMP (Committee for Human Medicinal Products) delegate for the UK.
So, on Monday 29 January, Panorama promises to reveal the secret trail of internal emails which show how GSK manipulated the results of Seroxat trials in children for its own commercial gain.
The documents also reveal how the company continued to deny safety problems with the drug despite three investigations by Panorama reporter Shelley Jofre.
Almost a year ago there was another leak of secret data, this time from Dr Peter Breggin.
Each and every time more damning information becomes public, we are asked to believe that Ian Hudson did not have full knowledge of ALL the trials and data that appertained to Seroxat. Hudson was Glaxo’s Worldwide Director of Safety and had, in his own words, “a significant involvement in Paroxetine” (Seroxat).
What adds insult to injury is that this is the same Ian Hudson who now heads up the drug licensing operations of the UK regulator, the MHRA.
This is also the same Ian Hudson who decided not to appear to be questioned by the House of Commons Health Select Committee – although several senior figures from the Medicines and Healthcare Products Regulatory Agency attended the session, the committee said that it would also have liked to have heard evidence from Ian Hudson. MPs wanted to question Dr Hudson about the company’s drug paroxetine (marketed as Seroxat in Britain and as Paxil in the United States).They were particularly interested in evidence concerning the safety and efficacy of the drug in people under the age of 18.
And so we come back to the subject of the new Panorama programme which shows how GSK manipulated the results of Seroxat trials in children for its own commercial gain…
I’d like someone to ask Dr Ian Hudson where he was and what he was doing when all this was going on at Glaxo – when he had “significant involvement in Paroxetine” (Seroxat) and he was Glaxo’s Worldwide Director of Safety.
Panorama, Monday 29 January 2007, BBC One 20.30.