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Safety and Efficacy of Statins Have Been Exaggerated, Scientists Say

Report claims advocates use statistics to amplify drugs’ beneficial effects

Hailed as miracle drugs when they entered the market two decades ago, statins, the cholesterol-lowering drugs prescribed to prevent heart attacks, are not so effective nor so safe as we have been led to believe, say 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 diseases.

According to Diamond and Ravnskov, statins produce a dramatic reduction in cholesterol levels, but they have “failed to substantially improve cardiovascular outcomes.” The authors further state that the many studies supporting the efficacy of statins have not only neglected to account for the drugs’ numerous serious adverse effects, but the supporters of statins have used what the authors refer to as “statistical deception” to make inflated claims about the drugs’ effectiveness.

The authors’ critique of the exaggerated claims regarding statins’ ability to prevent strokes, heart attacks, and heart disease-related deaths on a large scale was published in the Expert Review of Clinical Pharmacology.

Their paper is an analysis of the data in statin trials that led them to conclude 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.”

The paper also describes how the basis of the alleged deception is in how authors of the statin studies present the rate of beneficial and adverse effects. The effect of the drugs on the population is called the “absolute risk,” which has shown that statins benefit only about 1% of the population. This means that only one out of 100 people treated with a statin will have one less heart attack. Statin researchers, however, don’t present the 1% effect to the public, the authors say. Instead, they transform the 1% effect using another statistic, called the “relative risk,” which creates the appearance that statins benefit 30% to 50% of the population.

The exaggeration of the beneficial effects of statin treatment was illustrated in their analysis of a subset of statin studies, including the Jupiter Trial, the Anglo-Scandinavian Cardiac Outcomes Trial Lipid-Lowering Arm (ASCOT-LLA), and the British Heart Protection Study.

“In the Jupiter trial, the public and health care workers were informed of a 54% reduction in heart attacks, when the actual effect in the reduction of coronary events was less than 1 percentage point,” Diamond and Ravnskov said. “In the ASCOT-LLA study, which was terminated early because it was considered to have such outstanding results, there were heart attacks and deaths in 3.0% of the placebo group 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 inflated claims for the effectiveness of statins and the minimized portrayal of the drugs’ adverse effects have played a role in the enthusiasm of health care providers and the public for cholesterol-lowering treatments, the authors say.

According to Diamond and Ravnskov, “increased rates of cancer, cataracts, diabetes, cognitive impairments, and musculoskeletal disorders more than offset the modest cardiovascular benefits of statin treatment.”

The authors note that low cholesterol levels related to statin use have often been associated with an increased risk of cancer. They also note that most statin trials are terminated within 2 to 5 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, the authors say.

In Britain, leaders in health care research, including the editor-in-chief of the British Medical Journal, have called for drug companies to release all of their records related to the undisclosed adverse effects of statins in their clinical trials.

Diamond and Ravnskov advocate other treatment strategies that are known to reduce cardiovascular risk, such as smoking cessation, weight control, exercise, and stress reduction. They also emphasize the value of a low-carbohydrate diet for normalizing the biomarkers of cardiovascular risk.

The authors conclude their paper with the following statement: “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."

Source: EurekAlert; February 20, 2015.

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