Article Questions Statin Use, Fails to Disclose Study Authors' Biases

“Effectiveness of Statins Is Called into Question,” an article by Melissa Healy in the Los Angeles Times, notes that statins, a widely prescribed class of medications used to treat and prevent heart attack and stroke, and that includes some of the most recognized and lucrative brand names on the market (Lipitor, Crestor, Zocor, and others), have come under “tough scrutiny” recently as studies have called into question the use of statins for primary prevention of heart attack and stroke (ie, for reducing “the risk of a first heart attack in people who have high LDL cholesterol but are nonetheless healthy).

In the article, John Abramson, MD, Harvard Medical School, said that the message around statins amount to “a conspiracy of false hope” abetted by a public that “wants an easy way to prevent heart disease, doctors [who] want to reduce their patients' risk of heart disease and drug companies [that] want to maximize the number of people taking their pills.” Abramson has written several articles that have been critical of the overuse of statins, including “Cholesterol Lowering, Cardiovascular Diseases, and the Rosuvastatin-JUPITER Controversy: A Critical Reappraisal,” published in the June 28, 2010 issue of Archives of Internal Medicine. In the article, Abramson and colleagues showed that the JUPITER trial -- which purported to show that statin use produced a “substantial decrease in the risk of cardiovascular diseases among patients without coronary heart disease and with normal or low cholesterol levels” -- was “flawed,” with several major discrepancies in the data, particularly in regards to the “surprisingly low” reported rates of cardiovascular mortality and myocardial infarction fatality. This led the authors to strongly suspect that the “possibility that bias entered the trial” and conclude that the “results of the trial do not support the use of statin treatment for primary prevention of cardiovascular diseases.”

In fact, the LA Times article notes that in addition to the article by Abramson, et al. the June issue of Archives of Internal Medicine featured two other studies on the efficacy of statins for primary prevention of cardiovascular disease in otherwise healthy people who are at risk for a first heart attack or stroke. One found that “contrary to widely held belief, statins do not drive down death rates among those who take them to prevent a first heart attack.” The authors of that article, “Statins and All-Cause Mortality in High-Risk Primary Prevention: A Meta-analysis of 11 Randomized Controlled Trials Involving 65,229 Participants,” found that “The use of statins in [the] high-risk primary prevention setting was not associated with a statistically significant reduction” in the risk of all-cause mortality. The second article, “By Jove! What Is a Physician to Make of JUPITER?” cast "significant doubt” on results from JUPITER that have “driven the expansion of statins' use by healthy people with elevated blood levels of C-reactive protein,” according to the LA Times.

Pretty damning stuff, at first glance. However, the LA Times article failed to mention that two of Abramson’s coauthors aren’t the most unbiased sources when it comes to research on stains, cholesterol, and its effscts on cardiovascular health. Back in July, CardioBrief’s indefatigable Larry Husten said that there may be more to this than meets the eye, noting that two of Abramson’s co-authors, Michel de Lorgeril and Harumi Okuyama, are members of the International Network of Cholesterol Skeptics (THINCS) http://www.thincs.org, which Husten labels “an obscure, cult-like group of cholesterol skeptics” who “consistently seeks to denigrate the beneficial effects of statins and to highlight what they perceive as serious and widely pervasive side effects (including cancer) of the drugs.”

Husten went so far as to say that the paper authored by the THINCS members “is not really part of the scientific process, since the authors have no interest in the give and take of medicine and science.” This because, according to Husten, THINCS members “don’t just object to one trial (JUPITER), or just one drug (rosuvastatin), or just the use of statins for primary prevention. They raise objections about ALL cholesterol-lowering trials, ALL cholesterol-lowering drugs, and the use of statins in ALL populations. They constantly harp on the dangerous side effects of statins, and exploit any bit of evidence they can find to launch their attacks, always ignoring the considerable evidence that doesn’t support their views.”

Pretty strong words, but well worth considering when trying to evaluate the evidence surrounding this topic, especially when it comes from a respected commentator such as the scrupulously fair and open-minded Husten (who, to his credit, admits in the post linked to above that his criticism is a bit of an ad hominem attack). To bolster his case against the impartiality of THINCS, Husten linked to this post from the Science-Based Medicine blog.

Additional reading:

More on the JUPITER trial, statins, and all things THINCS from DrRich, of the Covert Rationing Blog.