"After Sally Clarke’s death, another loving mother who was branded a …." (Daily Mail) "COT DEATHS SALLY DIES HEARTBROKEN" (The Mirror); "Broken woman who was haunted to an early grave" (Independent); "Sally Clarke, wrongly jailed for killing sons, found …" (Guardian) [Google News, 29 March 2007]

Sally Clarke (42) died last week, four years after her release from jail. She had served over three years of a life sentence for murdering her two children. The key to her conviction was the representation by an expert witness, Professor Sir Roy Meadow, that the odds of her innocence were, statistically, barely conceivable.

Too late it became clear that Meadow had convinced himself and the court on the basis of ropey calculations. His evidence in this and other cot death cases had led to the conviction and imprisonment of several mothers accused of killing their infants.

The truth that finally emerged - both sickening and liberating for the victims - was understandably found "saddening" by Meadow’s professional colleagues. This was a terrible and miserable lapse for a man, said by the head of his Royal College to have had "a long and distinguished career in paediatrics in which he has undoubtedly saved the lives of many children."

To some extent, that makes it seem all the more creditable that the General Medical Council should bring the action against Meadow, and then vigorously pursue it. The public interest was at stake: "The chair of the GMC panel considering Sir Roy's case said it was vital the public had confidence in the experts brought before the court and that was why he had to be struck off, rather than be given a lesser penalty".

But did the punishment really fit the crime? Meadow professed expertise and demonstrably failed to produce it, in circumstances that caused great suffering and harm – but to what extent did this warrant the finding that he was unfit to practice? The decision to remove his name from the Medical Register seemed partly to reflect the limited remit of the GMC, rather than pure justice. The sentence needed to be severe, but perhaps the main imperative was to discredit Meadow for ever as a court witness, rather than consign everything of his experience and commitment to some professional dustbin. Perhaps arrogance made the difference: who knows?

The finding that Meadow was unfit to practise medicine underlines the problems that might arise in questioning the professionalism of Professor Sir Alasdair Breckenridge, Chairman of the Medicines and Healthcare products Regulatory Agency (MHRA), and the impact of his calculations. The central issue is not to do with his fitness to practice. In medical practice, Breckenridge may well set standards to which most doctors should aspire. He is a distinguished clinical pharmacologist, albeit knighted in 2004 "for his role in ensuring British patients receive safe medical treatment".

Surely, what applies to an expert medical witness in a courtroom applies even more to the Chairman and erstwhile mouthpiece of the MHRA, the centrepiece of the drug control system? And what if a doctor in a position of unique responsibility gives an expert opinion, not in a courtroom about a single case - but on national television, when thousands of ‘cases’ might be badly affected by what he says?

The main difference is of course to do with proving the connecting causal chain - making the link between utterances and actual harm. Meadow’s victims were clearly identifiable and their pain and suffering was clear. But who suffered, and how, because of anything Breckenridge said? That will never be clear, though the underlying issue remains the same: it is vital that the public has confidence in the experts relied on.

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 website of Breckenridge leading the regulatory charge. Consider, in particular, this new correspondence about 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 inadquate 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.

The GMC found that Sir Roy's conduct had been "fundamentally unacceptable", but it hardly operates as a forum for laying the evidence that, in a different context, the same might be true of Sir Alasdair too. At least 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 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.

Charles Medawar
30 March 2007