How statistical deception created the appearance that statins are safe and effective in primary and secondary prevention of cardiovascular disease

Abstract

We have provided a critical assessment of research on the reduction of cholesterol levels by statin treatment to reduce cardiovascular disease. Our opinion is that although statins are effective at reducing cholesterol levels, they have failed to substantially improve cardiovascular outcomes. We have described the deceptive approach statin advocates have deployed to create the appearance that cholesterol reduction results in an impressive reduction in cardiovascular disease outcomes through their use of a statistical tool called relative risk reduction (RRR), a method which amplifies the trivial beneficial effects of statins. We have also described how the directors of the clinical trials have succeeded in minimizing the significance of the numerous adverse effects of statin treatment.

Keywords:

• absolute risk
• adverse effects
• cancer
• dementia
• hypercholesterolemia
• myositis
• relative risk
• statins
• trials

Financial & competing interests disclosure

D Diamond was supported by a Career Scientist Award from the US Department of Veterans Affairs. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Key issues

• The almost exclusive presentation of data in the relative risk format by statin advocates has intentionally misled the public to exaggerate the miniscule benefits of statins.

• Primary-preventive cholesterol-lowering trials have not succeeded in reducing the rate of mortality.

• The absolute risk reduction of CVD mortality in secondary-preventive cholesterol-lowering trials is quite small, rarely exceeding two percentage points, and no primary-preventive trial has ever succeeded in prolonging the life of the participants.

• The rate of serious adverse effects of statin treatment is highly underestimated.

• Adverse effects of statins are extensive, including diabetes, cognitive impairments, cancer, cataracts and musculoskeletal disorders.

• The small benefit seen in the cholesterol-lowering trials is independent of the degree of cholesterol lowering.

• Approaches to improving cardiovascular outcomes that should be emphasized are the cessation of smoking, avoidance of obesity and to consume foods low in sugar and partially hydrogenated fats and high in saturated fats, such as coconut, butter, eggs and full fat cheese.

Notes