A Commentary in the Lancet by John Abramson, MD, of Harvard Medical School, author of Overdosed America, and James Wright, MD, University of British Columbia, challenges the validity of the U.S. clinical practice guidelines recommending the expanded use of statins by healthy people.
The authors argue that recommendations for the expanded use of statins to stave off cardiovascular disease are NOT supported by the evidence.
It should be noted that: "For adults aged between 30 and 80 years old who already have occlusive vascular disease, statins confer a total and cardiovascular mortality benefit t and are not controversial."
But the revised U.S. guidelines (2001) increased the target population to be treated with statins from 13 million to 36 million Americans. That increase offers huge economic implications for the manufacturers of statins.
The guidelines, the authors say, "are based on the assumption that cardiovascular risk is a continuum and that evidence of benefit in people with occlusive vascular disease (secondary prevention) can be extrapolated to primary prevention populations. This assumption, plus the assumption that cardiovascular risk can be accurately predicted, leads to the recommendation that a substantial proportion of the healthy population should be placed on statin therapy."
The controversy involves this question: which people without evident occlusive vascular disease (true primary prevention) should be offered statins? The authors note that in formulating recommendations for primary prevention, the authors of the guidelines did not rely on the data that already exist from the primary prevention trials. Indeed, the authors note that the guidelines cite seven and nine randomised trials, in support of statin therapy for the primary prevention of this disease in women and people aged over 65 years. Yet NOT ONE of the studies provides such evidence.
Furthermore, they note: "the absolute risk reduction of 1.5% is small and means that 67 people have to be treated for 5 years to prevent one such event. Further analysis revealed that the benefit might be limited to high-risk men aged 30-69 years.
Statins did not reduce total coronary heart disease events in 10,990 women in these primary prevention trials.
Similarly, in 3,239 men and women older than 69 years, statins did not reduce total cardiovascular events.
"Our analysis suggests that lipid-lowering statins should not be prescribed for true primary prevention in women of any age or for men older than 69 years. High-risk men aged 30-69 years should be advised that about 50 patients need to be treated for 5 years to prevent one event."
Vera Hassner Sharav
ALLIANCE FOR HUMAN RESEARCH PROTECTION
Promoting Openness, Full Disclosure, and Accountability
Here is the commentary by Abramson and Wright as published in The Lancet: