WILL THE MHRA DECIDE TO PROSECUTE GLAXOSMITHKLINE?

Once a year, since 2004, I have made FOI requests to the MHRA, asking about the progress of the possible prosecution of GlaxoSmithKline for failing to report safely data about the ill-effects of Seroxat in children. Last year, I posted this note on the matter:

February 2007    The MHRA has, to date, spent between 14 and 30 person years (maybe 1m of drug industry funding) in not deciding to prosecute GlaxoSmithKline, since its investigation began in October 2003. Last month the Agency told Panorama, "that the investigation has been given substantial additional resources and remains a high priority" - but their latest communication on the subject suggests anything but …

The reality is that any prosecution of the Company would put the Agency itself - and Chairman Breckenridge in particular - too squarely in the frame. What was it he told Panorama for the second of their four splendid programmes? (11 May 2003) -  "What you can say with great firmness is that these drugs do not increase the risk of suicidal thought and they do not increase the risk of suicide". If that's the Agency's best assessment after more than a decade of drug investigation, personally spearheaded by the blunt tool, Breckenridge, why should the law expect GSK to do any better? I'd sooner argue that GlaxoSmithKline was fit for purpose (serving shareholders), than the MHRA (safeguarding public health).

Last Monday, I sent the MHRA a request for an update on the possible prosecution. Today is Wednesday, and early tomorrow morning the MHRA will be briefing a coterie of journalists, apparently to explain that they either are going to prosecute GSK or are not. Tomorrow we shall find out if I told you so, or got it wrong.

On this eve of enlightenment, I am reflecting again about the position of the MHRA Chairman. Last year’s note continued: "Professor Sir Alasdair Breckenridge clearly should have retired some time ago - indeed he should never have been appointed".

If the MHRA does decide to prosecute, it has to signal Breckenridge’s impending departure – but perhaps retirement rather than a long-overdue resignation. Breckenridge speaks for the MHRA and his view is that neither he, nor the Agency has anything to apologise for. Half way through the investigation of GSK, this is what he said, at a seminar jointly sponsored by Pfizer and (remarkably) the New Statesmen.

"If you go back – and I read this out to the Health Select Committee – to the data sheet on Seroxat when it was licensed in 1991, we spelt out word for word the problems of withdrawal from Seroxat, in words that we could not improve now. This idea that the regulators have been hiding the data is just not true. 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." (http://www.newstatesman.com/200506200051 20 June 2005 Fears, phobias and facts)

All this conveys to me something of the toxicity of power. The arrogance seems monumental and the capacity for self-justification unlimited. It seems to have little to do with the point of science, as learnt at my father’s knee. A good scientist is uncompromising as a seeker after truth. By contrast, the devout regulator is a seeker after political truth and compromise, guided always by notions of their own deep understanding of some ‘greater good’.

Thoughts of personal and professional interest matter too. Never mind the knighthoods and lesser honours. If they prosecute, how will it be for the five members (n=20) of the Commission on Human Medicines who get research grants from GlaxoSmithKine? The CHM has professional oversight of the MHRA.

Even at this 11th hour, I’d stake lots at 100-1 (odds on) that there will be no prosecution – yet I’d be mighty happy to be proved wrong. It might just signal that the penny had dropped: that the regulators had at last begun to appreciate how wrong they have been all along.

Last week’s revelations that antidepressants are substantially ineffective echo the question I first put to the drug regulators in 1998: "Do antidepressants work?" I thought it unlikely: the evidence suggested that drug withdrawal symptoms and dependence supported the illusion of drug efficacy, as with benzodiazepine tranquillisers a generation before. This was certain, at the latest by 2005.

Professor Sir Alasdair Breckenridge has played the most decisive part in this regulatory farrago. He continues to presides over a system which has for the past 15+ years exposed hundreds of thousands of people to the risk of significant damage, when there was no expectation of drug benefit (over placebo).

But which way will he and they jump? At the time of writing, only tomorrow will tell.

Charles Medawar
5 March 2008

 

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