“Fundamentally flawed.”

Such was the consensus by critics who reviewed a major study that was published in the Lancet, which concluded that statins prevent approximately 80,000 cases of major cardiovascular events, such as myocardial infarction and strokes, annually.

The group of doctors who wrote in The Prescriber criticised the methods of which the Lancet study was carried out, stating that it was “scientifically misleading and an attempt to stifle important public debate.”

They also pointed out that the study had a systemic form of statistical manipulation, in which some data behind the trials were not published, and that outcomes of the drug were based not on concrete evidence, but rather on forecasts.

Millions more to start on statins based on revised NICE guidelines

The controversy over the use of statins has been ongoing for years, after the National Institute for Health and Clinical Excellence (NICE), in 2013, advised physicians to prescribe statins for patients with a 10% risk of heart disease – half that of the previous recommendation of 20% risk.

This meant that an addition of 4.5million people became eligible for statins, although they were in good health.

Millions of people globally take statins to lower cholesterol levels, and though the new recommendations meant that more people would be started on the medication, doctors in certain countries such as Singapore have already been aggressive in the use of statins.

“Cardiologists in Singapore have already been treating cholesterol aggressively with high doses of statins for their heart patients; essentially, as high as patients can tolerate,” said Dr Ong Hean Yee, head of cardiology at Khoo Teck Puat Hospital in Singapore.

Overmedication of millions worldwide

According to the Lancet study, which analysed 20 years’ worth of data and conducted by Oxford University and the London school of Hygiene and Tropical medicine, only 2% of patients suffer side effects from taking statins such as muscle pain, memory loss and depression.

However, doctors who criticised the study had different views.

“Decades of misinformation on cholesterol and the gross exaggeration of statin benefits with downplaying of side effects has likely led to the overmedication of millions of people across the world,” said lead author and consultant cardiologist Dr Aseem Malhotra.

“The lack of transparency in the prescription of statins is just one symptom of a broken system of healthcare where finance based medicine has trumped independent evidence and what is most important for patients,” added Malhotra, whose views were supported by Harvard statins expert Dr John Abramson, former president of the Royal College of Physicians, Sir Richard Thompson, and Professor Sherif Sultan, the president of the International Society for Vascular Surgery.

Unless the raw data is revealed, he said, claims of any benefits or side effects of statins cannot be considered as evidence based.

Criticisms launched at Dr Malhotra

While many supported Malhotra’s stance, others, such as professor Sir Nilesh Samani who is the medical director at the British Heart Foundation, refuted his claims.

“This paper (by Malhotra) combines data and opinion that risks confusing patients about the benefits and safety of their statins,” he said.

“The evidence from numerous independent clinical trials going back more than two decades shows that statins are an effective way of people reducing their risk of a heart attack.”

Professor Mark Baker from NICE, also emphasised that the revised guidelines were based on the “overwhelming body of evidence supporting the use of statins”, even for those were at relatively low risk.

“The effectiveness of statins is now well proven, as is their long-term safety, and they are relatively cheap,” Baker said.

"To make progress in the battle against heart disease and stroke we must encourage exercise, improve our diets still further, stop smoking, and where appropriate offer statins to people at risk.”

However, former president of the Royal College of General Practitioners (RCGP), Professor Iona Heath stressed that the ongoing controversy over statins risks the general public losing trust in biomedical science and research.

“The controversy will only be resolved if all existing research data is made widely available for review by genuinely independent researchers,” Heath added. MIMS

Read more:
HDL-boosters: A paradox in cardiology and a letdown in the drug industry
Revaluating statins: Are the benefits understated & harms exaggerated?
Pharmacist-led treatment: Using ideal cholesterol goals as an example