Statins, the cholesterol-lowering drugs prescribed to prevent heart attacks, are not as effective nor as safe as we have been led to believe, researchers say. Statins produce a dramatic reduction in cholesterol levels, but have failed to substantially improve cardiovascular outcomes, they add, stating that ‘statistical deception’ has been used to inflate claims about their effectiveness.
Hailed as miracle drugs when they hit the market more than two decades ago, statins, the cholesterol-lowering drugs prescribed to prevent heart attacks, are not as effective nor as safe as we have been led to believe.
Dr. David M. Diamond, a professor of psychology, molecular pharmacology and physiology at the University of South Florida, and Dr. Uffe Ravnskov, an independent health researcher and an expert in cholesterol and cardiovascular disease published their analysis of statin therapy in the Expert Review of Clinical Pharmacology under the heading ‘How statistical deception created the appearance that statins are safe and effective in primary and secondary prevention of cardiovascular disease.’
When statins hit the market more than 2 decades ago they were hailed as ‘Miracle Drugs’. These cholesterol-lowering drugs that are widely prescribed to prevent heart attacks, are not as effective nor as safe as we have been led to believe.
According to Diamond and Ravnskov, statins are very effective in lowering cholesterol levels but they have “failed to substantially improve cardiovascular outcomes.” Their paper further state that the many studies promoting the value of statins have not only failed to consider the many serious side effects of the drugs, but that the supporters of statins have used “statistical deception”, as referred to by the authors, to make exaggerated claims about their efficacy.
Their critical assessment of the inflated claims about statins’ ability to prevent strokes, heart attacks and heart disease-related deaths on a large scale has been published in the medical journal Expert Review of Clinical Pharmacology.
In their paper they analyse data in various statin trials which leading to their conclusion that “statin advocates have used statistical deception to create the illusion that statins are ‘wonder drugs,’ when the reality is that their modest benefits are more than offset by their adverse effects.”
In their paper they also describe the root of the deception. It is all in the manner in which the authors of the statin studies present the rate of beneficial and adverse effects. The effects of drugs on the entire population is called the ‘absolute risk’. Using the absolute risk methodology, statins only benefit about 1% of the population. This means that only 1 person out of 100 people taking a statin will have one less heart attack. Instead of presenting the 1% effect to the public, statin researchers use another statistical methodology called ‘relative risk’. By presenting the results as ‘relative risk’ they create the appearance that statins benefit 30-50% of the population.
This exaggeration of the beneficial effects of statin treatment was exposed in their analysis of a subset of statin studies, including the Jupiter Trial (Crestor), the Anglo-Scandinavian Cardiac Outcomes Trial Lipid Lowering Arm (ASCOT-LLA), and the British Heart Protection Study.
Ravnskov and Diamond said that in the Jupiter trial, the public and healthcare workers were informed of a 54% reduction in heart attacks, when the actual effect in reduction of coronary events was less than 1 percentage point. The authors further mentioned that in the ASCOT-LLA study, which ended early because it was considered to have such outstanding results, there were heart attacks and deaths in 3% of the placebo (no treatment) group as compared to 1.9% in the Lipitor group. The improvement in outcome with Lipitor treatment was only 1.1 percentage point, but when this study was presented to the public, the advertisements used the inflated (relative risk) statistic, which transformed the 1.1% effect into a 36% reduction in heart attack risk.
The exaggerated claims for statin effectiveness, and minimized representation of the adverse effects, has played a role in the health care providers and the public’s enthusiasm for cholesterol-lowering drugs, say the authors.
“The adverse effects suffered by people taking statins are more common than reported in the media and at medical conferences” explains Diamond and Ravnskov. According to the authors, “Increased rates of cancer, cataracts, diabetes, cognitive impairments and musculoskeletal disorders more than offset the modest cardiovascular benefits of statin treatment.”
The authors emphasized that low cholesterol levels related to statin use have frequently been associated with an increased risk of cancer. They also noted that most statin trials are terminated within two to five years, a period too short to see most cancers develop. Nevertheless, studies have shown a greater incidence of cancer in people who take statins, and one long-term study demonstrated a dramatic increase in the incidence of breast cancer among women who had used statins for more than 10 years.
They stressed that the public needs to be wary of conflicts of interest in the medical community and pharmaceutical industry when it comes to hyping the benefits of statins and twisting the data in such a way as to make the drugs seem more effective at lowering cardiovascular disease and heart attack risks than they may actually be.
Diamond and Ravnskov’s paper is particularly relevant at this time as reports out of Britain have revealed that leaders in health care and research, including the editor in chief of the British Medical Journal, Fiona Godlee, and the chair of Britain’s Commons Health Select Committee, Sarah Wollaston, have called for drug companies to release all of their records involving undisclosed adverse effects of statins in their clinical trials.
“We welcome more medical journals to follow the new rules introduced by the British Medical Journal stating that ‘clinical education articles will be authored by experts without financial ties to industry’,” say Diamond and Ravnskov.
The authors advocate other health beneficial strategies that are known to reduce cardiovascular risk, such as stop smoking, weight control, exercise and stress reduction. They also emphasized the great value of a low carbohydrate diet for normalizing all of the biomarkers of cardiovascular risk, with excellent outcomes, especially for people with type 2 diabetes.
Diamond and Ravnskov concluded their paper with the sobering statement that “There is a great appeal to the public to take a pill that offers the promise of a longer life and to live heart attack free. The reality, however, is that statins actually produce only small beneficial effects on cardiovascular outcomes, and their adverse effects are far more substantial than is generally known.”
David M Diamond, Uffe Ravnskov. How statistical deception created the appearance that statins are safe and effective in primary and secondary prevention of cardiovascular disease. Expert Review of Clinical Pharmacology, 2015; 8 (2): 201 DOI: 10.1586/17512433.2015.1012494
Materials provided by University of South Florida (USF Health).