11/06/2014 08:58 BST | Updated 11/06/2014 08:59 BST

Group Of UK's Leading Doctors Speak Out Against Millions Being Prescribed Cholesterol-Reducing Statins

PAUL J. RICHARDS via Getty Images
Lipitor(atorvastain calcium) tablets made by Pfizer and distributed by Parke-Davis are seen November 30, 2011 in Washington, DC. Pfizer's patent on the best-selling drug of all-time, the cholesterol-lowering medication Lipitor, expired on November 30, 2011, opening the path to generic competitors for America's most popular medication. Lipitor came on the market in 1997, and has raked in some $100 billion for Pfizer even in a crowded market that includes various other cholesterol-lowering statins

A group of leading doctors have criticised plans to advise millions more people to take cholesterol-reducing statins.

The drugs are currently offered to as many as seven million people in the UK who have a 20% risk of developing cardiovascular disease within 10 years.

Draft guidance from the National Institute for Health and Care Excellence (Nice) has called for the NHS to widen this to cover people with just a 10% risk.

But a number of prominent clinicians have written a letter to Health Secretary Jeremy Hunt to express their concerns.

London cardiologist Dr Aseem Malhotra said: "Although there is good evidence that the benefits of statins outweigh the potential harms in those with established heart disease, this is clearly not the case for healthy people.

"For example a doctor wouldn't give chemotherapy to a patient who didn't have cancer or prescribe insulin to someone without diabetes.

"When you add up doctors' appointments, unnecessary suffering for those who experience side effects that interfere with the quality of life, the illusion of protection of taking a drug that won't reduce the risk of death in healthy people - and the increasing burden of chronic disease which is predominantly lifestyle-related - prescribing statins to millions of healthy people would increase costs to the NHS, not reduce it."

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The signatories, including the president of the Royal College of Physicians and a former chairman of the Royal College of General Practitioners, claim that the latest guidance is based almost entirely on studies funded by the pharmaceutical industry.

The group cite findings from non-industry sponsored studies which include an increased risk of developing diabetes in middle aged women taking statins.

Other side effects include fatigue, psychiatric symptoms and erectile dysfunction, the clinicians warn.

They also claim that the "medicalisation of millions of healthy individuals" is unjustified.

Professor Simon Capewell, professor of clinical epidemiology at the University of Liverpool, said: "Two decades of research has confirmed the obvious: doctors receiving drug industry funding produce recommendations favouring the industry.

"It also represents a further embarrassment for Nice.

"Nice urgently need to develop a better mechanism for controlling these conflicts of interests. The recent statin recommendations are deeply worrying, effectively condemning all middle aged adults to lifelong medications of questionable value."


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But Professor Mark Baker, director of the centre for clinical practice at Nice, insisted that the draft guidance does not propose that statins should be used instead of lifestyle adjustments by people at risk of cardiovascular disease.

He said: "Cardiovascular disease maims and kills people through coronary heart disease, peripheral arterial disease and stroke. Together, these kill one in three of us. Our proposals are intended to prevent many lives being destroyed.

"We have consulted on these proposals and the results of this consultation are currently being reviewed prior to publication of our final recommendations next month. Our proposals are also being independently peer reviewed to ensure they are reliable and evidence-based."

Professor Baker stressed that Nice guidance is developed by independent expert committees and none of them support the recommendations to make money for themselves.

He added: "This guidance does not medicalise millions of healthy people. On the contrary, it will help prevent many from becoming ill and dying prematurely.

"We recognise that strong views are held by some on both sides of the argument about the best way to use statins, but our job is to reach a balanced judgement. Concerns about hidden data and the bias that the pharmaceutical industry may or may not have are important issues and need to be resolved.

"Nice is part of the effort to do that but just as the signatories to the letter will have done in their professional careers, we need to act in the best interests of patients on the basis of what we know now."