Unsafe Heart Medication Peddled to Public as Wonder Drug

By Donald W. Light, Science Progress. Posted December 23, 2008.

While President-elect Barack Obama's health team, along with insurers and employers around the country, are working out why we pay so much for health care that provides little measurable benefit, one reason for those unnecessarily high costs recently made every evening news show and front page.

Bloomberg News announced, "AstraZeneca's Crestor slashed the risk of heart attack, stroke and death by nearly half in people with normal or low cholesterol in a study, potentially opening a way to save the lives of thousands of seemingly healthy people." MSNBC News made the same announcement and then quoted the president of the American College of Cardiology: "This takes prevention to a whole new level." Ron Winslow of The Wall Street Journal added, "The findings could substantially broaden the market for statins, the world's best-selling class of medicines." Except for USA Today, which worried about the high cost to patients, health plans, and the public, most announcements read like infomercials, excited about a major new market.

In short, this "pathbreaking" study that "takes prevention to a whole new level" actually offers little benefit and offsets it with a costly side effect.

These news headlines referred to a large clinical trial published on November 20th in the New England Journal of Medicine that purported to demonstrate the effectiveness of Crestor -- even on older patients with low cholesterol who scored high on a test for CRP, or C-reactive protein. CRP levels are used as an imprecise indicator of heart disease, though the molecule is "a nonspecific marker for low-grade inflammation," according to Dr. Bernadine Healy, an adviser to U.S. News and World Report.

Almost no one learned that the "slashed nearly in half" reduction in cardiovascular trauma was tiny, from 1.36 percent to 0.77 percent, a difference of just 0.59 percent.

And almost none of the stories reported that the people taking Crestor had a comparable increased risk (0.60 percent) of getting diabetes. Those that did said the increase was "small," but then so was the reduction in cardiovascular events. Suppose newscasters announced, "Major study finds patients taking Crestor for systemic inflammation experience less than 1 percent reduction in cardiovascular events and an equal increase in diabetes"? In short, this "pathbreaking" study that "takes prevention to a whole new level" actually offers little benefit and offsets it with a costly side effect.

American medicine is rife with such commercial bandwagon tests, procedures, and drugs. An effective policy solution would involve the creation of a comparative effectiveness institute that offered independent evaluations and subjected treatments to head-to-head trials in order to make recommendations about which ones are actually worth the money. President-elect Barack Obama's health care platform calls for such an entity, and in August, Senate Finance Committee Chair Max Baucus, D-Mont., and Senate Budget Committee Chair Kent Conrad, D-N.D., introduced the "Comparative Effectiveness Research Act," legislation that would create a nonprofit institute.

The closer you look, the less beneficial this breakthrough looks. For example, the investigators had screened out 80 percent of their sample so that the trial included only patients with a high CRP but without 13 other prevalent health risks. Those 13 risks include a history of cardiovascular disease, diabetes, arthritis, high blood pressure, cancer, hypothyroidism, or substance abuse. Also excluded were people taking hormone replacement therapy or lipid-lowering therapy.

Put another way, the vast majority of older women and men with low cholesterol and high CRP were excluded because they had conditions that might weaken the results. The trial aimed to select just those people who were most likely to produce a dramatic result but establish the basis for everyone to take the test to see if they have high CRP. If they do, they probably have other risks or behaviors like those people screened out of the trial, so taking Crestor (the most expensive statin) might or might not increase their risk for diabetes and reduce their risk for cardiovascular trauma.

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