New York Times distorts research on statin drug therapy

By Kate Randall
9 April 2010

The New York Times has conducted a yearlong effort in support of the Obama administration’s health care policies. Numerous articles and editorials have argued that “unnecessary” medical treatments and procedures must stop, “overly generous” insurance plans must be reined in, and billions in “excessive waste” must be slashed from the Medicare program.

In the wake of the bill’s passage, an article prominently placed on the paper’s front page—“Risks Seen in Cholesterol Drug Use in Healthy People” by Duff Wilson (March 30)—is the latest effort in the Times’ campaign to promote Obama’s cost-cutting proposals.

The topic of the article is a decision earlier this year by the Food and Drug Administration (FDA) to approve AstraZenaca’s drug Crestor, a statin, for use by a section of people without high cholesterol levels.

The Times makes the argument that healthy people are being given a drug that places them at dangerous risk for developing diabetes. It claims to have medical research to back up these claims, and points to “mounting concern” that statins “may not be as safe a preventive medicine as previously believed for people who are at low risk of heart attacks or strokes.”

The problem is that the research referred to in the article, published in the February 27 issue of the Lancet, concludes the exact opposite of what the Times claims. While the Times asserts that the benefit of statins “may not outweigh any side effects,” the Lancet article specifically states that “the benefit seems to greatly outweigh the risk.”

The Cholesterol Treatment Trialists’ Collaborators research published in the Lancet studied just over 91,000 individuals from 13 large placebo-controlled trials over a mean of four years. It found that those trial participants assigned statins were at a 9 percent increased risk of developing diabetes mellitus.

The data showed that if 255 patients were treated for four years with a statin, one additional patient would develop diabetes than had they not received the drug. By contrast, among this same group over the same four years, 5.4 deaths or heart attacks would be avoided, as well as nearly an equal number of strokes or coronary bypass surgeries—or about 9 to 1 in favor of the cardiovascular benefit, according to the study.

A further article in the same issue of the Lancet notes: “For statins, the benefits in reducing clinical events have been shown in a multitude of trials with over 500,000 patient-years of treatment.” While it says that “this newly identified [diabetes] risk does warrant monitoring,” it concludes that “the risk seems small and far outweighed by the benefits of this life-saving class of drugs.”

The author of the Times article is particularly concerned about the FDA’s approval of the expanded use Crestor. He writes, “The new Crestor label says it may be prescribed for apparently healthy people if they are older—men 50 and over and women 60 and over—and have one risk factor like smoking or high blood pressure, in addition to elevated inflammation in the body.”

“Under those criteria,” the article notes, “an estimated 6.5 million people in this country who have no cholesterol problems and no sign of heart problems will be deemed candidates for statins.”

First of all, by characterizing these people as “apparently healthy,” the article dismisses the well-known medical fact that smoking and high blood pressure put people at risk for heart disease. It also seeks to downplay the role of inflammation in heart disease.

But more importantly, by claiming that these “apparently healthy” people will allegedly be exposed to an unwarranted risk of developing diabetes, the article suggests that this segment of the population—which studies have shown would benefit from statin therapy, and could avoid some of the risks of heart disease—should not receive the drug.

Statins work by inhibiting an enzyme called HGM-CoA reductase, which controls cholesterol production in the liver. Nearly all heart attacks begin with the buildup of plaque in the arteries, which can form even when blood cholesterol is low. Statins have also been shown to reduce heart disease by preventing this atherosclerosis plaque buildup, which can break off and move through the bloodstream, causing a heart attack or stroke.

While the Times stresses that “There is no consensus in the medical community that inflammation is a direct cause of cardiovascular problems,” multiple clinical studies have shown that statins have an anti-inflammatory effect that contributes to lowering the risk of atherosclerosis and preventing catastrophic cardiovascular events.

The FDA’s approval of the expanded use of Crestor—which is the subject of the Times article—was based on a global clinical trial involving nearly 18,000 people. The study looked at patients who had low cholesterol levels and an elevated level of inflammation in the body, which is measured by a test called high-sensitivity C-reactive protein, or CRP.

Dr. Paul M. Ridker, a Harvard medical professor and cardiologist at Brigham and Women’s Hospital in Boston, is the inventor of the CRP test. He persuaded AstraZeneca to sponsor the clinical trial, which he led. The Times writes that the study “showed a small but measurable reduction of strokes, heart attacks and other ‘cardiovascular events’ among people taking the statin, compared with patients taking a placebo.”

The article quotes Dr. Ridker, who said recently, “We found a 55 percent reduction in heart attacks, 48 percent reduction in stroke, 45 percent reduction in angioplasty bypass surgery.”

Statistics from the AstraZeneca study showed the following: The rate of heart attacks among the Crestor patients was 0.17 percent, or 31 patients; for those taking the placebo, the rate was 0.37 percent, or 68 patients—more than twice as many.

The Times complains, however, that this “difference between the two groups translates to only 0.2 percentage points in absolute terms—or 2 people out of 1,000.” They add, “Stated another way, 500 people would need to be treated with Crestor for a year to avoid one usually survivable heart attack” (emphasis added).

“At $3.50 a pill,” the Times argues, “the cost of prescribing Crestor to 500 people for a year would be $638,000 to prevent one heart attack,” adding, “Is it worth it?” As far as they’re concerned, preventing that one man or woman from suffering a heart attack—along with the pain, anxiety and potential threat to life that comes with it—does not warrant the cost.

More broadly, however, the Times reporting on health care—and its campaign in support of the Obama administration’s health care agenda—is driven by a right-wing motives. The newspaper and its reporters represent those privileged sections of the ruling elite who stand to profit most from its cost-cutting features and the gutting of health care for workers and the poor. Specifically, it is aimed at legitimizing the deprivation of broad masses of working people of medications and treatments that have been proven to be effective.

The Times has paid particular attention to supposed “overtreatment” for cardiovascular disease. Several years ago, the paper ran an aggressive campaign against the use of heart stents to open up blocked arteries, claiming that drug treatment (i.e., statin therapy) was equally effective. Now the Times is targeting statins, utilizing outright falsifications of scientific research in an attempt to advance its reactionary political agenda.

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