The paper, Seroxat and the suppression of clinical trial data: regulatory failure and the uses of legal ambiguity, was written by L McGoey1 and E Jackson 2 and is available through download here [it's a paid service]
Fortunately, I have some very alert readers, one of which sought fit to send me this particular paper in its entirety. Kudos to that person [they know who they are]
For the record, I have sent this particular paper on to both Kent Woods, CEO of the MHRA and Alasdair Breckenridge, Chairman of the MHRA and asked for an official response. Whether I get a response is another matter. I do feel some sort of response would be in the public interest particularly as the MHRA claim to safeguard public health.
It baffles me why the BMJ has to be a paid service because this particular paper should be available to the public for free. I don't blame the authors of the paper here, I'm blaming the BMJ.
The official abstract of the paper [which is free] reads:
This article critically evaluates the Medicines and Healthcare products Regulatory Agency’s announcement, in March 2008, that GlaxoSmithKline would not face prosecution for deliberately withholding trial data, which revealed not only that Seroxat was ineffective at treating childhood depression but also that it increased the risk of suicidal behaviour in this patient group. The decision not to prosecute followed a four and a half year investigation and was taken on the grounds that the law at the relevant time was insufficiently clear. This article assesses the existence of significant gaps in the duty of candour which had been assumed to exist between drugs companies and the regulator, and reflects upon what this episode tells us about the robustness, or otherwise, of the UK’s regulation of medicines.
Like many patient advocates, I have been a long time critic of the MHRA, in particular their 'closeness' toward pharmaceutical companies, who, at the end of the day, pay the MHRA's wages. Only recently I highlighted a recent campaign where the MHRA had joined forces with Pfizer to create awareness about the dangers of buying prescription drugs over the Internet.
Many of my readers will know of the GSK/MHRA connection - Chairman, Alasdair Breckenridge is a former employee of GlaxoSmithKline as is Ian Hudson, Head of Licensing at the MHRA.
Hudson, in the main, has remained quiet over the Seroxat debacle. Breckenridge, on the other hand, has been outspoken with his views on Seroxat. Halfway through the GSK investigation, Alasdair Breckenridge told a seminar, "The so-called scandal of Seroxat is something I want to nail every time I speak in front of compatriots because it is absolute rubbish.”
Hardly surprising that Breckenridge would make such a statement. He was after all a member of the Scientific Committee of SmithKline Beecham from 1992 to 1997. What is surprising is the timing of Breckenridge.
To be honest, I see Alasdair Breckenridge as a liability for the MHRA. His arrogance shows utter disdain for those affected by Seroxat. The sooner he resigns his position of Chairman, the better it will be for all concerned. I would, however, like my day with Breckenridge. I would like to show him my own personal timeline [6 years] on Seroxat. "So-called scandal" it most definitely is not and neither he, GSK or their highly paid legal team will ever be able to tell me otherwise.
Anyway, I digress. Back to the BMJ paper.
For copyright reasons I'm not allowed to publish the paper in it's entirety. I have emailed one of the authors to ask his permission but have yet to receive a reply. I can however highlight some points raised in the paper.
In October 2008, the MHRA announced an amendment to the 1994 Medicines for Human Use Regulations. It's basically 'an ammendment to ensure UK legislation is fully in line with existing EU law covering the circumstances when marketing authorisation holders should report new information which might influence the evaluation of the benefits and risks for a medicine to the MHRA.'3
The authors of the BMJ paper suggest that this ammendment became necessary following the MHRA’s revelation, on 6 March 2008, that there would be no prosecution of GlaxoSmithKline for withholding clinical trial data.
McGoey and Jackson briefly explain the reason for this paper but more importantly offer their views as to why the MHRA failed to prosecute. It is something that never really occured to me and has really given me much food for thought. They reflect upon what this episode tells us all about the robustness, or otherwise, of the UK’s regulation of medicines and disect the legal framework which enabled GlaxoSmithKline to avoid prosecution.
The authors also draw attention to the role of the MHRA's funding structure, in particular its need to compete with other European regulators for licensing fees, as well as its wish to evade ‘‘reputational risk’’.4 They deduce that the case of Seroxat and the missing trial data casts uncertainty upon the MHRA’s capacity to fulfil its own ‘‘mission statement’’. 5
Most of the Seroxat Sufferers readers are aware of the history as to why the MHRA carried out an investigation into GSK. In a nutshell GSK submitted papers to the MHRA in May 2003. The papers were 329 and 377 clinical trials which tested the efficacy of paroxetine (Seroxat) in children and adolescents in the mid-1990's.
In early 2004, a confidential, internal GSK document was leaked that indicated that there had been a deliberate decision to withhold Studies 329 and 377 from regulators. The document was dated 1998.
There are Internal documents from GSK down the right hand side of this blog for further reading.
Basically, for five years GSK had witheld important safety information from the MHRA during which time Seroxat became one of the biggest selling antidepressants on the market. In 1999
over 32,000 prescriptions for Seroxat had been issued to children in the UK. In other words, over 32,000 children and adolescents were prescribed a drug that was unlikely to work, and which carried a risk of a serious and probable fatal, adverse reaction. Remember, this is just one year [1999]
McGoey and Jackson state: "We do not know how many, if any, under 18's actually committed suicide between 1998 and 2003 as a result of taking Seroxat, but given the large number of children involved, it is certainly possible that deaths occurred which could have been avoided by prompt disclosure of this information."
There are two high profile cases known throughout Alasdair Breckinridge's 'so called Seroxat scandal' that I have highlighted on this blog many times. Those being the tragic circumstances of Sara Carlin and Sharise Gatchell. Both hanged themselves, both were prescribed Seroxat, both were under 18. It's highly likely to all that had they not been prescribed Seroxat then they would probably be settling down to a Sunday roast with their parents today. If that is defamatory and offends GSK and/or the MHRA then maybe they would like to argue the point with me... or better still, explain to the parents of Sara and Sharise why they were prescribed a drug that carried a risk of death?
McGoey and Jackson's paper is a MUST read and I'm sure it will be available for a free download pretty soon. I'd appreciate it if one of the two authors I emailed would give me permission to publish the paper in its entirety because it is a paper that seriously highlights the failures of the MHRA and begs the question; Did the MHRA fail to prosecute GSK because a high-profile criminal trial would have highlighted their own faults and processes?
For those of you with access to BMJ articles, I strongly recommend that you download the full paper.
Fid
**Amendment - GSK published the findings of study 329 in 2001, but completely repressed findings from two other randomized clinical trials: 377 and 701.
Hat tip: Alison Bass Author of Side Effects: A Prosecutor, a Whistleblower and a Bestselling Antidepressant on Trial (Algonquin Books) - http://www.alison-bass.com/
1 James Martin Institute,
Business School, Oxford
University, Oxford, UK;
2 London School of Economics and
Political Science, London, UK
3. http://www.mhra.gov.uk/NewsCentre/CON028540
4. Power M. Organized uncertainty: designing a world of risk management. Oxford:
Oxford University Press, 2007.
5. http://www.mhra.gov.uk/index.htm
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