And so, once again, I find myself writing about the MHRA and one of its most senior figures – in fact THE most senior – its Chairman, Professor Sir Alasdair Breckenridge.
I think that Charles Medawar has pointed out that Breckenridge has a lot of explaining to do… if I can join the queue I’d like him to explain to me why he has not resigned yet and why he has not done anything to protect the public from Seroxat.
Anyone looking in from the outside can see there is something wrong with the MHRA – what it says, what it does and the relationship that it has with the Pharmaceutical industry.
At this point, I’ll hand you over to Charles Medawar:
The question then is about Breckenridge’s fitness for purpose in leading the MHRA, not his fitness in medical practice. In his official capacity, he seems to have compromised and exploited his status as a doctor and scientist – making and now casually ‘standing by’ a number of too rash and sweeping statements about the safety of antidepressants in general, and Seroxat® (and Zyban®) in particular. The fact that Breckenridge was for many years a paid consultant to the manufacturers of those drugs doesn’t help. However, impropriety is not the point: it’s about being seen to be unbiased, transparent and committed to doing no harm.
In his public pronouncements on these drugs, Breckenridge seems to personify what the Parliamentary Health Committee (2005) said about the MHRA: “some complacency and a lack of requisite competency … oblivious to the critical views of outsiders and unable to accept that it had any obvious shortcomings… ” These would be poor qualities in any doctor, and there are too many examples on this [Social Audit] website of Breckenridge leading the regulatory charge. Consider, in particular, what Breckenridge said in the third of the four Panorama programmes (Taken on Trust, October 2004).
In his interview, (including the bits that weren’t broadcast), he bent over backwards to defend Seroxat® and other antidepressants – and by extension, his own record and reputation. More than anyone, Breckenridge led the Agency’s many investigations of these drugs, and repeatedly they emerged with a positive bill of health. Time and again, his judgements later proved wanting – all the more reason to examine the evidence he relied on. Here, for example is Breckenridge on Panorama, shooting from the hip:
Breckenridge: “In fact, what you can say is that the prescribing of SSRIs has increased dramatically since the 1980s, (the) end of the 1980s (and) the risk of suicide has fallen dramatically in that period of time.”
A few weeks later, the MHRA published the conclusion of its Expert Working Group: “Studies generally indicate that increases in the prescribing of SSRIs have not been associated with an increase in population suicide rates, although interpretation of these findings is difficult …”
In these circumstances, one might well ask why Professor Sir Alasdair Breckenridge should now entrust his professional reputation to an MHRA Media Relations Manager. The original questions were surely reasonable: why did he say such things and do they now seem justified? But the answers come from a functionary who is professionally committed, if not exploited, to protect top reputations. She assures us that: “Sir Alasdair stands by the comments he made in the full pre-recorded show”. Her letter concludes: “I would like to reassure you that our Chairman and other spokespeople for the MHRA always ensure that they give robust and fact based judgements to ensure that benefits to patients and the public justify the risks.” I bet she would, but she is far off the mark.
The Agency’s posture seems to illustrate another fatal flaw in the drug control system – the conflict between political and scientific correctness – and Breckenridge never quite managed to reconcile the two. All too often he relied on insufficient or inadequate evidence and put the precautionary principle aside. For years he maintained that Seroxat® withdrawal symptoms were rare and typically mild; now he would have to accept that they were very common and often quite severe. Nor could he now sustain the categorical assurances he gave on Panorama, that such drugs “do not cause suicide, they do not cause suicidal thoughts in adults”. They can and sometimes do.
….some guidance from the GMC would be welcome here. In the meantime, such is the state of the UK medicines’ control system, that Breckenridge can rely on Agency procedures and staff to protect himself against even a catalogue of evidence of ‘conduct unbecoming’. I [Charles Medawar] have previously argued that Breckenridge should resign and increasingly believe that, had he been worth his salt, he would already have done so. Alas, I also have to accept that he will never get the heave-ho: now I just wish that he would quietly go.