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Meanwhile, women on Crestor were more likely to develop diabetes compared with those getting a placebo — a result not seen in men. And because the trial lasted only 1.9 years on average, researchers say the full magnitude of the side effects may not have been captured.
Judith Hsia, senior director for clinical development at AstraZeneca, which makes Crestor, says the trial was designed to measure the statin's effect on all end points together, not individual end points. "The people who had bypass surgery or stenting would not characterize that as a nonevent," says Hsia. "It's not death, but it's still substantial."
It's the Risk Profile, Stupid
Why statins fail to show equal benefits for men and women is unclear, but one reason may be that women are simply at lower risk of heart disease than men. You would need a powerful treatment to lower an already low risk. Researchers also don't know why women are more likely than men to suffer side effects from statins and many other drugs but posit that lower body weight and hormonal fluctuations play a role. Biological explanations aside, the larger point is the same: with any treatment, the benefits should outweigh the risks.
Margaret, 59, who asked that her last name be withheld, says her experience with statin side effects was harrowing. Margaret was in her early 50s and had high cholesterol and diabetes when her doctor put her on statins. Soon after, she says, she forgot how to do basic math and got lost driving to familiar places. But when she described the symptoms, she says, her doctor refused to believe they were related to the drugs. "I felt like I was going crazy," says Margaret, "but within a week or two of stopping the statins, my brain started to work again."
Many doctors may be so unfamiliar with the side effects of statins, says Golomb, that they deny their connection to the drugs. That may contribute to the underfiling of adverse-drug-reaction reports with the Food and Drug Administration (FDA).
The FDA seems unperturbed by criticism of the Jupiter trial. In February, on the basis of Jupiter data, the agency expanded the eligible patient population for Crestor to include older healthy at-risk adults. The move could increase the number of women taking statins by many millions, according to calculations by Dr. Jon Keevil of the University of Wisconsin. Researchers will continue to disagree over whether that is heartening news or not.