WATANI International
11 April 2010
With the government’s blessing, a drug giant is about to expand the market for its blockbuster cholesterol medication Crestor to a new category of customers: as a preventive measure for millions of people who do not have cholesterol problems.
Some medical experts question whether this is a healthy move.
They point to mounting concern that cholesterol medications — known as statins and already the most widely prescribed drugs in the United States — may not be as safe a preventive medicine as previously believed for people who are at low risk of heart attacks or strokes.
Statins have been credited with saving thousands of lives every year with relatively few side effects, and some medical experts endorse the drug’s broader use. But for healthy people who would take statins largely as prevention — which would be the case for the new category of Crestor patients — other experts suggest the benefits may not outweigh any side effects.
Among the risks raising new concerns, recently published evidence indicates that statins could raise a person’s risk of developing Type 2 diabetes by 9%.
There is also debate over the blood test being used to identify the new statin candidates. Instead of looking for bad cholesterol, the test measures the degree of inflammation in the body, but there is no consensus in the medical community that inflammation is a direct cause of cardiovascular problems.
The Food and Drug Administration approved the new criteria last month for Crestor, which is made by AstraZeneca and is the nation’s second best-selling statin, behind Lipitor by Pfizer.. Under those criteria, 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. That is in addition to the 80 million who already meet the current cholesterol-based guidelines — about half of whom now take statins.
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.
Some patients have long complained of muscle aches from taking statins. And doctors periodically check patients on the drugs to make sure liver enzymes are not abnormally high. Doctors, though, have generally seen those risks as being more than offset by the drugs’ benefits for people with high levels of “bad” cholesterol and a significant risk of cardiovascular disease.
The F.D.A. acknowledged the diabetes risk, and told AstraZeneca to add it to Crestor’s label. But the agency nonetheless approved the new use on the basis of the clinical study, which 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.
Dr. Eric C. Colman, a deputy director of the F.D.A. center for drug evaluation, said the decision provided an option, not a mandate, for doctors and patients. “It’s good to hear that physicians are debating the potential benefits and risks of drugs,” Dr. Colman wrote via e-mail.
An F.D.A. advisory committee had voted 12-4 in favor of expanding the usage in December, with some dissenters questioning the value of the test measuring elevated levels of inflammation.
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The New York Times (abridged)