Controversy in Modern Clinical Research

Tony Blair’s memoirs [1] are an interesting read for people who lived through the years of his rise to prominence and premiership. In them he makes the interesting point that he found a lack of empirical evidence to guide decisions once he had been handed the reins of power – choosing which objectives to pursue is a political choice he said, but how to reach a selected objective should be an instrumental issue to be resolved by the evidence. Aziz Sheikh and colleagues give an interesting account of the evaluation of the National Programme for Information Technology,[2] which started while Blair was Prime Minister, and which continues to produce output to this day.[3] The evaluation programme was commissioned by the CLAHRC WM Director on behalf of the Department of Health, and was the brain-child of Sir Muir Gray.

But evidence is not always conclusive, not even in the world of clinical evidence. Controversies are rife – clot-busting drugs for stroke, Tamiflu® and now statins.[4] A disheartening feature of these debates concerns the amount of personal vindictive that is manifest. It is natural for human beings to seek turpitude in the actions of others. That is why the ‘ad hominem’ fallacy – discrediting an argument by discrediting the person behind the argument – is so ubiquitous. While this practice comes naturally to us humans, scientists should be educated to rise above it and ‘play the ball, not the person’. Prof Sir Rory Collins seems to have fallen at this fence in making a connection between those who claim that statins have frequent side-effects and those who perpetrated the MMR fraud.[5] From a purely technical point of view, the CLAHRC WM Director sides with Sir Collins, who gives much more weight to the RCT evidence on side-effects than the observational and anecdotal evidence. However, he thinks Collins is in danger of exceeding the bounds of propriety in his attack on those with a different opinion and personally interceding with Fiona Godlee, editor of the BMJ. Meanwhile, other scientists are thinking up imaginative ways to collect more evidence – Iain Chalmers suggests a randomised trial of treatment withdrawal, while CLAHRC WM Deputy Director, Tom Marshall, proposes a series of n=1 trials.

I understand that we will have a chance to witness further controversy concerning clot-busting medicines in acute stroke, when Roger Shinton and the MHRA take opposing views in this weekend’s Lancet.

–Richard Lilford, CLAHRC WM Director

References:

  1. Blair T. A Journey. London, UK: Arrow Books. 2010.
  2. Sheikh A, Atun R, Bates DW. The need for independent evaluations of government-led health information technology initiatives. BMJ Qual Saf. 2014; 23: 611-3.
  3. Petrakaki D, Waring J, Barber N. Technological affordances of Risk and Blame: the Case of the Electronic Prescription Service in England. Social Health Ill. 2014; 36(5): 703-18.
  4. Hawkes N. Risks in the balance: the statins row. BMJ. 2014; 349: g5007.
  5. Deer B. How the case against the MMR vaccine was fixed. BMJ. 2011; 342: c5347.
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