Statins side effects: Doctors urged to conduct urgent review of drugs
The MP’s call comes amid proposals to allow patients to get the medication from high street chemists without the need for a prescription. There have also been contradictory claims about benefit versus harm of the drugs, which is taken by millions of Britons. Mr Lamb, chairman of the Commons science and technology committee, has requested Professor Chris Whitty to conduct an independent assessment of statins.
The Liberal Democrat MP for North Norfolk, who is stepping down at the next election, was contacted by leading health professionals calling for an inquiry.
Mr Lamb, 61, became concerned about the side effects after he was prescribed with statins last year following a minor stroke.
He said: “Patients are being faced with an unacceptable confusion over what we are being told about these drugs.”
Mr Lamb said he was worried that data from statins trials “had not been independently examined” and was based on “industry sponsored evidence”.
Supporters say statins lower the risk of heart disease and stroke with rare side effects. Detractors argue that the side effects are often severe and widespread and that the harm outweighs the benefits.
Mr Lamb stated that raw data was needed to reach a conclusion.
He said: “I received a letter from 20 very eminent clinicians raising significant and legitimate issues about statins and weighing up the reduction in mortality and prevalence of heart attacks against the risk of side effects heart disease and strokes.
“Our prescribing system is based on industry sponsored evidence that has not been independently examined nor fully disclosed and I struggle to understand why we cannot have transparency of the raw data to resolve this dispute and give patients the reassurance we need.
“I am left in a difficult situation being told different things by two groups of eminent clinicians and this needs to be resolved.”
He added: “Before we allow these drugs to become widely available from high street chemists without a GP prescription surely we first need to establish a consensus on this, but until we can see the full trial data how can we know?” He said: “I am not in a position to judge who is right on this. But the controversy needs to be resolved.”
Statins, taken by eight million people are the most commonly prescribed drugs in the UK. Some experts claim the medication should be given to the over-75s.
Mr Lamb’s letter to Prof Whitty was triggered by a letter sent to him from a group of experts and clinicians including the Queen’s former doctor Professor Sir Richard Thompson, the former President of the Royal College of Physicians.
The letter was organised by leading NHS heart specialist and obesity specialist Dr Aseem Malhotra. Signatories include Dr Fiona Godlee, editor in chief of the BMJ, as well as GPs and international heart experts.
It argues that the failure to share the raw data from industry sponsored statins trials dating back many years means doctors have not been able to have proper transparency over the benefits of the drugs against the potential side effects.
It states: “In the absence of an analysis of the clinical trial data carried out by an independent group, with full access to the raw data, there is good reason to believe that the benefits of statins have been ‘overhyped’, especially in those at high risk of cardiovascular disease, and the potential harms downplayed, unpublished or uncollected.” Analysing results of studies it throws doubts on claims that increased life expectancy from statins is statistically significant.
The letter concludes: “All (signatories) are strongly of the view that such confusion, doubt and lack of transparency about the effects of a class of drug that is so widely prescribed is truly shocking and must be a matter of major public concern.”
Prof Thompson added: “The idea that patients should be able to buy these over the counter in high doses is potentially dangerous if side effects are greater than previously thought and if they also have a small or insignificant effect on prolonging life.
“The evidence needs to be reviewed in an unbiased and balanced way.”
A spokeswoman for the Medicines and Healthcare products Regulatory Agency said: “The benefits of statins are well established and considered to outweigh the risk of side effects in the majority of patients.”
She added it “welcomed” the initiative to widen access to statins, adding: “Patient safety is our highest priority and we work to make sure the benefits of medicines outweigh the risks.” Prof Whitty will be taking over from Dame Sally Davies as chief medical officer next month.
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