Voices of caution are responding to recent breathless headlines about the supposed heart-health benefits of statin drugs. Publications including Fox News, the Wall Street Journal and the New York Times claimed "that millions more people could benefit from taking the cholesterol-lowering drugs known as statins." As health reporter Andre Picard points out, the net health benefits from statins are actually "modest."
The headlines were based on a study published in the New England Journal of Medicine. However, the study failed to impress Merrill Goozner of the Integrity in Science Project at the Center for Science in the Public Interest. Goozner reviewed the study closely and found it interesting mostly for "what it reveals about profit-driven medical research and how it contributes to making the U.S. health care system the most bloated and wasteful in the world."
Goozner points out that AstraZeneca, the drugmaker that funded the study, will make "an additional $2 billion-plus in sales" if it can get two million more people to take its statin drug, while the study's lead researcher would stand to make "$2 million a year in extra income." Worse still, a close reading of the study shows "flaws in its construction, biases in its analysis," and "slants in its presentation."
For starters, the study only looked at a select group of "men over 50 and women over 60," more than half of whom were significantly overweight -- hardly a population that should be used to reach health conclusions about the broader general public. Even in this group, the benefits were marginal at best. People who took the drug had fewer heart attacks, but they "developed diabetes at a higher rate than the group given a placebo. ... In other words, for every person who didn't get a serious cardiovascular event, three-quarters of a person got diabetes." In the end, "the number of 'serious adverse events' in both arms of the trial was almost exactly equal: 15.2 percent in the statin arm versus 15.5 percent in the placebo arm. ... In other words, giving a statin to people with elevated CRP did nothing to improve this population's overall health."
At best, Goozner says, the study shows that statin treatments would prevent one serious cardiac event for every $285,000 spent on the drug. "Can you imagine," Goozner writes, "how many heart attacks and strokes could be prevented if that money were targeted at people who are truly at risk of heart disease (the obese, smokers, hypertensives, diabetics) to help them modify their lifestyles and get treatment for their underlying conditions?"
"Within a few years," Goozner predicts, "health care payers will be forking over billions more dollars to the statin drug makers in the name of preventing heart disease. Meanwhile, our health care outcomes -- including cardiovascular disease -- will still rank somewhere between Romania and Poland. Health care costs will still be rising at twice the rate of overall inflation. And those truly at risk of heart disease still won't be getting the counseling that might save their lives."
The New York Times, to its credit, followed its initial glowing report on the statin study with a more cautious story that contained some of the same caveats noted by Goozner and concluded, "many healthy people are likely to get an exaggerated view of statins' benefits." However, the media's initial willingness to uncritically report a medical "breakthrough" has already created an impression in people's minds. Let's hope the overhyped early version of this story doesn't become the one that shapes opinions and drives public health decisions.