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Some studies warn: 'caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk.'

It's been a year since a Cochrane Collaboration meta-analysis of 14 previously published studies called into question the common medical practice of prescribing statins to people who have high cholesterol but no history of heart disease.

The Cochrane researchers, a highly respected international group of independent researchers, concluded that there were serious "shortcomings" in the published studies to date on statins and recommended that "caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk."

Another meta-analysis, published just a few months earlier, had come to a similar conclusion, but a third one, also published in 2010, had not. And so, the debate about whether or not statins should be prescribed to low-risk individuals continues.

hopkinsmedicine.org

Dr. Roger S. Blumenthal

That debate got a good airing over the weekend in the Wall Street Journal. Editors asked two cardiologists, Dr. Roger S. Blumenthal, professor of medicine and director of the Johns Hopkins Ciccarone Center for the Prevention of Heart Disease, and Dr. Rita Redberg, professor of medicine and director of women's cardiovascular services at the University of California, San Francisco, to make their best case for (Blumenthal) or against (Redberg) giving statins to otherwise healthy people. (There's very little controversy over whether statins should be given to high-risk people: those with a history of heart disease.)

I have to say, I was dumbfounded by a couple of Blumenthal's statements. Here's one: "We don't prescribe drugs to otherwise healthy people without rigorous scientific evidence." Well, we may have evidence for the safety and effectiveness of each of our prescription drugs, but it's not always that rigorous — as tragically demonstrated by Vioxx, the arthritis medication that was pulled off the market in 2004 after it was found to cause dangerous heart problems.

Also, after acknowledging that statins have not been tested on low-risk people in a long, large prevention trial (it would be too "expensive and unwieldy"), Blumenthal suggests that we can instead rely on meta-analyses for evidence of the drugs' benefits to low-risk individuals.

Only, he doesn't mention that the findings of two of those meta-analyses (including Cochrane) don't support his argument.

Blumenthal does mention two specific studies in his essay:

[A] study of 6,600 Scottish men who hadn't had heart attacks showed a decrease in mortality rates after five years with statin therapy. Likewise, the recent world-wide Jupiter study of men and women without prior heart disease showed statins significantly decreased the risk of death after two years in people with an average age of 66.

Critics raise a number of complaints about these studies — exaggerated, in my view — but many other large prevention trials of people with multiple risk factors have consistently shown reductions in total cardiovascular events of 30 percent to 40 percent with the use of a statin.

But Redberg disagrees:

[M]any individual studies that statin boosters claim as success stories are flawed. One large study, conducted in Scotland, showed a reduction in mortality among men who used statins for a few years. The study, though, looked at a high-risk group of men for whom the benefits of statins were most likely to outweigh the risks; most were smokers and obese, and some had heart disease. Those results can't be extrapolated to most Americans taking statins today.

Another well-publicized study that showed good short-term results among healthy people taking statins, the Jupiter trial, remains controversial. The results have been questioned by many experts, who note anomalies in the reported findings and strong conflict-of-interest issues for the sponsor and investigators.

ucsf.edu

Dr. Rita Redberg

"Many doctors, including me, believe that we need clinical trials that actually follow healthy people treated with statins for the long term to see if treatment really results in lower mortality," Redberg added. "Statin proponents think such trials would be prohibitively expensive. That's a disappointing stance, considering the billions that have already been spent on statin prescriptions and advertising."

Redberg doesn't mention it, but as both she and Blumenthal know, it was just such a clinical trial — the Women's Health Initiative — that found, contrary to the prevailing medical belief, that menopausal hormone therapy raised rather than lowered the risk of heart disease.

You can read Blumenthal and Redberg's point-counterpoint articles on the WSJ's website.