BMJ editor asks chief medical officer to set up inquiry into statin risks and benefits

BMJ 2016; 354 doi: (Published 16 September 2016) Cite this as: BMJ 2016;354:i5046
Letter from Fiona Godlee, editor in chief of The BMJ, to Sally Davies, chief medical officer for England
  1. Nigel Hawkes
  1. London

The editor in chief of The BMJ, Fiona Godlee, has called for an independent inquiry into the evidence on the risks and benefits of statins.

In a letter to the chief medical officer for England, Sally Davies, Godlee urged her to intervene in what had become “a bitter and increasingly unproductive dispute.” Though there was good evidence of the benefits of statins to people with cardiovascular disease or otherwise at high risk, the benefits of taking them by people at lower risk was hotly contested, Godlee said, as was the true incidence of side effects such as muscle pain and fatigue.

Her intervention was triggered by the publication in the Lancet of a review of statins that, Godlee said, was intended to bring an end to any further public debate.1 The review, led by Rory Collins of Oxford University, concluded that patients and doctors had become confused because they placed too little faith in randomised controlled trials and too much in observational studies.

The trials, Collins and colleagues asserted, have demonstrated the benefits of statins and shown that side effects, though real, are rare. From the evidence from randomised controlled trials, he said, 80 000 cardiac events were being prevented each year in the United Kingdom, where six million people take statins, but only 600 cases of muscle pain were being caused. In addition, some 50-100 new diagnoses of diabetes were being generated.

Godlee said that the review was neither independent nor systematic, lacked methodological detail, and applied much less rigour to the data on harms than the data on benefits. The headline figures were based on unrealistic reductions in cholesterol concentrations, and the limitations of the trials were ignored, she said. These included the limited number of older people included in the trials and the fact that some trials had a run-in period that led to people with muscle pain being excluded before randomisation.

The review was published before Collins has even begun a promised review of patient level data on side effects from the trials, which he undertook to do in February 2015, estimating that it would take a year. He acknowledged in response to a question from The BMJ that it has taken 18 months just to get agreement from trialists to make the data available and that analysis was yet to start.1 It had taken much longer than he expected, he said.

Earlier Davies had asked the Academy of Medical Sciences to examine the evidence on statins, but the academy’s review has become broader, looking at how drugs are evaluated rather than statins in particular. Godlee said in her letter that the academy would not in any case be the right body to carry out the inquiry she envisaged. Such a body would need to be international and authoritative, independent of financial and academic conflicts of interest, and committed to transparency and a patient centred approach.

Because The BMJ has been a protagonist in the statins dispute, Godlee said that she would be happy for the inquiry to review her actions and those of the journal as part of its work.

The Department of Health for England confirmed that Davies had received the letter but had yet to decide what action to take.



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