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Sunday 15 February 2015

Statins expert calls for safety checks over the drug

AN Oxford professor whose findings were central to the mass prescription of statins is to re-examine trial data after concerns over the heart drug.

Prof Rory Collins, whose research helped rubber stamp statins as safe, said his team will carry out a “challenging” reassessment of the evidence which will include studying all reported side effects.
Although the original research looked at the effect of statins on the heart and considered cancer risks it did not examine other side effects.
Separate studies and patient complaints have included muscle pain, cataracts, diabetes, fatigue and memory loss. Dr Collins, who championed the controversial drug, said the additional work was needed to convince the public that statins were safe.
Fiona Godlee, editor in chief of the British Medical Journal, which has spearheaded calls for access to statins data, said: “This is of real concern. We wrongly assumed all the details of possible side effects had been thoroughly assessed before new guidance effectively made tens of thousands of people eligible for this drug.
We now know this is not the case and would urge any re-analysis is done in the most transparent way.”
Her comments came as Dr Sarah Wollaston, chairwoman of the Commons Health Select Committee, called for drug companies to release all their trial data.
Her demand is echoed by experts at the British Medical Journal, which is writing to the authors of all the major statin trials asking for the release of findings which have not been made available for public or independent analysis.
This follows a massive expansion in statin prescribing under new guidance from the Government’s drug watchdog, the National Institute for Health and Care Excellence.
Dr Wollaston, Tory MP for Totnes, Devon, said: “I’m concerned there may be side effects that have not been reported. “Drug manufacturers should release all their trial data on statins so they are available for scrutiny.”
Last year Nice recommended statins be prescribed to low-risk patients with a one in 10 risk of heart disease over the next decade.
This includes almost every healthy man over 60 and woman over 65 – the equivalent of four in 10 adults in the country.
Most doctors accept that statins benefit high-risk patients but the move to widen prescriptions is controversial.
Medicines regulator Nice argued the move would save lives and was based on trial data which had been assessed by a group of researchers at Oxford University, who based their finding on 30 trials.
Head researcher Prof Collins admitted he had not seen the full data on side effects.
In an email to this paper he stated that his team had assessed the effects of statins on heart disease and cancer but not other side effects such as muscle pain.
Klim McPherson, professor of public health at Oxford University, said: “We know these drugs have side effects but we do not know if these have been assessed properly by the drug companies who carried out the trials.
“It is outrageous. Why do they not make their data available for scrutiny?” Prof McPherson, 73, who recently weaned himself off a two-year statin prescription after debilitating muscle pains, added: “Taking these drugs should be a matter of individual patient preference with patients fully aware of their risks, which at the moment is not the case.”
Last year leading doctors’ magazine Pulse revealed two thirds of GPs are disregarding Nice advice to offer statins to more patients.
Can we trust professor Collins to do a "challenging reassessment" when he steadfastly refuses to release all the data from from statin trials he has been involved with. His Oxford based statin research unit the CTT (Cholesterol Treatment Trialists Collaboration) receives funding of in excess of £268 million of which £217.5 million comes from Merck.

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