Prof Kim McPherson, a public health specialist, calls on Prof Sir Rory Collins, a fellow Oxford don, to publish full data on which new NHS statins guidance is partly based
9:05PM BST 14 Jun 2014
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One of the country’s most eminent public health experts has attacked the NHS rationing body for advising millions of people to take statins based on “wholly inadequate” evidence supplied by a fellow Oxford don.
Prof Kim McPherson said it was “foolhardy” to tell many patients over 50 to take the cholesterol-lowering drugs when the “evidence base” for such advice was insufficient.
The epidemiologist, who has led previous panels issuing NHS guidance, called on Prof Sir Rory Collins, who runs trials at Oxford on which the advice was partly based, to open up his studies to be independently reviewed.
Last week the National Institute for Health and Care Excellence (Nice), which drew up the draft guidance, admitted it was not given access to the full data.
Prof McPherson, 72, has written to Sir Rory to express concerns about possible side effects of the drugs, suggesting they had impaired his own “mobility and agility”.
He has now stopped taking them and said: “I am not going back on statins unless I have the evidence”.
Nice will publish its final recommendations on statins next month, after a public consultation. Its draft guidance recommends cutting the “risk threshold” for statins in half — meaning that the vast majority of men aged over 50 and most women over the age of 60 are likely to be advised to take the drugs to guard against strokes and heart disease.
Experts said the changes would mean that the number of patients advised to take cholesterol-lowering drugs was likely to rise from seven million to 12 million, leaving one in four adults on the medication.
In a letter they accused Nice of an “overdependence” on studies funded by the pharmaceutical industry, which are kept “hidden” due to commercial confidentiality agreements.
The group cited research, independent of the drug industry, showing that statins have been associated with a 48 per cent increase in the risk of diabetes in middle-aged women.
Other potential side effects could include depression, fatigue and erectile dysfunction, they warned.
Prof Mark Baker, director of NICE's centre for clinical practice, admitted the expert panel which drew up the guidance had partly relied on summaries of data from the Clinical Trial Service Unit at Oxford University, which is run by Sir Rory.
Prof Baker said the full data could not be released to NICE or independent researchers because the trials were “commercially funded” and the information was owned by drugs companies.
The unit receives tens of millions of pounds in funding from such firms, although Sir Rory has insisted its results “bear no relation to our funders.”
On Saturday Sir Rory said the group which criticised the guidance should be “ashamed of themselves”. Such concerns over statins could “cause very large numbers of unnecessary deaths from heart attacks and strokes”, he told the Guardian.
However Prof McPherson, who chairs the UK Health Forum, said he supported the points raised in the letter. He called on Sir Rory, a fellow epidemiologist, to allow the data on statins trials to be scrutinised by “independent reviewers”.
Prof McPherson told The Telegraph: “It is outrageous that Nice is making these pronouncements without seeing the data and without the data being seen by independent reviewers.”
He added: “My interpretation of the evidence base being used is that it is wholly inadequate to make such a prescription.
“As far as I can tell the trials were not properly done in the sense that there was not systematic, routine periodic double blind assessment of quality of life between treatment of control in all these trials, which you need.
"Also, in so far as there was, none of those data are available for public scrutiny.
“I think Nice making these slightly draconian rules on the basis of such an inadequate evidence basis is foolhardly.”
He added: “I have just stopped taking statins and I am much more agile than I was when I was on them. I want to know why, what is the evidence for it. I am not going back on statins unless I have the evidence.
“You imagine all this creaking an aching is a matter of aging, and it might not be.”
On Saturday Sir Rory intervened in a row over two recent academic papers in the British Medical Journal which questioned the widespread use of statins.
The authors have both withdrawn statements after some figures they cited were found to be incorrect, and the articles are being reviewed by the journal. Sir Rory said a third party, such as the General Medical Council or Department of Health, should carry out its own review of the articles.
