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Telling millions of healthy people to take statins risks harming 'many patients over many years', doctors warn Jeremy Hunt, the Health Secretary, and watchdogs
10:00PM BST 10 Jun 2014
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Millions of people over the age of 50 risk harming their health if they follow new NHS guidance telling them to take statins, leading doctors have warned the Health Secretary.
Proposals to advise 12 million people to take the drugs could have “worrying” consequences because the plans were borne out of an “overdependence” on studies funded by the pharmaceutical industry, they say.
The group cites 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 warn.
In a letter to Jeremy Hunt, the prominent clinicians, including the head of the Royal College of Physicians and a former chairman of the Royal College of General Practitioners, say that the majority of the National Institute for Health and Care Excellence (Nice) panel responsible for drawing up the guidelines has “direct financial ties” to firms that manufacture statins.
They say that those with “industry conflicts” should be barred from helping to prepare drug guidelines.
Nice will publish its final recommendations next month, after a public consultation. In February it announced its plans to cut 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.
Nice says the guidance will prevent many people from becoming ill and dying prematurely.
By contrast, recent academic papers have questioned the widespread use of statins, claiming that they cause harmful side effects and do not cut death rates — although the authors of two such articles in the British Medical Journal have since withdrawn statements after some figures they cited were found to be incorrect.
In their letter to Mr Hunt and Nice, nine doctors and academics warn that the guidelines will result in the “medicalisation of five million healthy individuals”.
They call on Nice to shelve the proposals until independent experts have been allowed to examine the data on which they have been based.
“The potential consequences of not doing so are worrying: harm to many patients over many years, and the loss of public and professional faith in Nice as an independent assessor,” they write.
“Public interests need always to be put before other interests, particularly pharma.”
The doctors and academics highlight a series of concerns that they say should result in publication of the guidance being delayed.
Led by Sir Richard Thompson, the president of the Royal College of Physicians, they accuse Nice of relying on “hidden data” to reach its conclusions, arguing that crucial studies have not been open to scrutiny. Almost all the research was funded by pharmaceutical firms and should be “open to analysis by a third party with appropriate expertise”, they write.
The doctors, who also include Prof Clare Gerada, a former chairman of the Royal College of General Practitioners, and Prof David Haslam, the chairman of the National Obesity Forum, added that they were “seriously concerned” that eight members of the Guideline Development Group had “direct financial ties to the pharmaceutical companies that manufacture statins”.
The eight members highlighted by the signatories included Dr Anthony Wierzbicki, the chairman of the panel, who declared involvement in a number of commercial clinical trials of new cholesterol-lowering drugs.
The doctors also drew attention to Emma McGowan, a specialist heart nurse who held a post sponsored by AstraZeneca for a year and has been paid by Amgen, another firm, to work on studies.
Dr Dermot Neely, the head of the clinical biochemistry department at Newcastle University and another member of the panel, has received funding from Roche Pharma, Genzyme, Aegerion, Amgen and Sanofi for taking part in “one-off advisory boards”.
All of the links to pharmaceutical firms were declared to Nice at the time that the panel was preparing guidance. The watchdog said in each case the involvement was “judged not to be specific enough to warrant withdrawal”.
A spokesman for Nice said: “The conflicts of interest declared by committee members involved in producing this guideline have been managed appropriately. They have not influenced in any way the draft recommendations on the use of statins.”
Responding to the letter, Prof Mark Baker, the director of the centre for clinical practice at Nice, said: “The independent committee of experts found that if a patient and their doctor measure the risk and decide statins are the right choice, the evidence clearly shows there is no credible argument against their safety and clinical effectiveness.”
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