FDA Panel Recommendation on Crestor Spurs Debate
Dec. 16, 2009— -- A U.S. Food and Drug Administration panel's recommendation that some adults with no prior heart problems should take the cholesterol-busting statin Crestor appears to have pitted cardiologists against many primary care physicians over the best use of the popular drug.
At stake in the debate is the health of millions of Americans who, if the recommendation is followed by the FDA, could soon find themselves urged by their doctors to take the drug.
"If the FDA accepts this recommendation, it will expand the number of Americans eligible for statin therapy by millions," said Dr. Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic.
A number of cardiologists voiced their support of the idea that the drug should be given to men age 50 or older and women age 60 or older who have LDL cholesterol levels of less than 130 mg/L and triglycerides of less than 500 mg/L if the patient also had an elevated blood level of an inflammation marker known as C-reactive protein, or CRP.
"The FDA correctly saw beyond some of the adverse effects that were rare in this very large group," said Dr. Howard Weintraub, clinical director of the Center for the Prevention of Cardiovascular Disease at New York University. "It will hopefully allow easier access to Crestor and will also motivate physicians to be more aggressive in patients at risk and encourage patients to accept the recommendation of therapy."
Another cardiologist, Dr. Christopher Cannon of Brigham and Women's Hospital in Boston, described the recommendation as "outstanding news for people who are at risk but who would not previously known it.
"The treatment can reduce almost in half their risk of a first heart attack or other cardiac event," he said.
Meanwhile, many primary care doctors were far from enthused.
"I disagree completely with this recommendation," said Dr. Lee Green, a primary care doctor at the Department of Family Medicine at the University of Michigan in Ann Arbor. "I don't think that the FDA recommendation is ready for prime time, and extending it would most certainly be bad science and bad patient care."
