According to Diamond and Ravnskov, statins produce a dramatic reduction in cholesterol levels, but they have "failed to substantially improve cardiovascular outcomes." They further state that the many studies touting the efficacy of statins have not accounted for the adverse side effects of the drugs, but supporters of statins have used what the authors refer to as "statistical deception" to make inflated claims about their effectiveness.
Their paper is a review of the data in the statin trials which 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 claims that the basis of the 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 they say shows 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 don't use an absolute 1% effect with the public, the authors state, and instead use the more common "relative risk," which the authors say only creates the appearance that statins benefit 30-50% of the population. They believe this is an exaggeration of beneficial effects of statin treatment, including in the Jupiter Trial (Crestor), the Anglo-Scandinavian Cardiac Outcomes Trial Lipid Lowering Arm (ASCOT-LLA), and the British Heart Protection Study.
They appear to be implying all of these other researchers are either uninformed or trying to deceive the public.
"In the Jupiter trial, the public and healthcare workers were informed of a 54 percent reduction in heart attacks, when the actual effect in reduction of coronary events was less than 1 percentage point," said Ravnskov and Diamond. "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% 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 inflated claims for statin effectiveness, and minimized portrayal 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 say 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.
The authors advocate other health beneficial strategies that are known to reduce cardiovascular risk, such as cessation of 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, "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."
Published in Expert Review of Clinical Pharmacology.