Wary from the Start

While some doctors may be changing the way they dispense Crestor, there are some who have been wary of the drug since its introduction in the United States in 2003.

These physicians are what Dr. Scott Fields, professor and vice chair of family medicine at Oregon Health and Science University in Portland, Ore., calls "slow adopters." Fields feels the rapidly changing landscape of medical science and technology challenges physicians to make changes in how they practice medicine.

"When a new medicine hits the market there are things that occur when open to wider use," explains Fields. "As such, some physicians hold back with using new medications and technology and wait it out to see what happens."

In the case of Crestor, Fields says when measured against other statins that have been on the market for a long time, Crestor's marginal economic and medical benefits are small.

"Currently there is no outcome evidence showing decrease in cardiac events or mortality," says Dr. Daniel McCarter, director of clinical affairs at the University of Virginia Department of Family Medicine in Nellysford, Va. "Therefore I see no reason to start using it."

With the label change, some doctors are reminded of the problems surrounding Baycol, a statin that was pulled from the market in 2001 due to reports it caused fatal muscle disease.

"I had hundreds of patients on Baycol. All of a sudden it was removed from the market. So, currently with the possible prospect of another market withdrawal, I will be more prepared and I am sure most physicians will be more cautious in prescribing Crestor from now on." says Dr. Albert Levy, clinical assistant professor of medicine at Mount Sinai School of Medicine in New York City.

But doctors such as Sidney Alexander, director of the Lipid Clinic at the Lahey Clinic Medical Center in Burlington, Mass., does not see Crestor following in Baycol's footsteps. Alexander, who prescribes Crestor, starts his own patients at 5 milligrams.

"The drug is safe when used properly. Baycol was associated with a high incidence of myopathy. At lower doses it [Crestor] is fine so it's not like Baycol." says Alexander.

Still Safe and Effective

Despite the revised drug label, AstraZeneca asserts the drug is still a safe and effective treatment, adding, "there is no change in the overall safety profile of Crestor, which remains similar to that of all other currently marketed statins."

Adds Gary Bruell, AstraZeneca's director of cardiovascular public affairs, "There was not a problem with the product. The problem was with the prescribing patterns of the product. We have not seen any instance of prescribing patterns here which mirror those that occurred in Europe."

The FDA affirms Crestor is safe when used accordingly, reminding doctors to carefully read and follow the product label.

And despite the reports, experts still believe statins are one of the safest and needed classes of drugs available.

"Their effect in cardiovascular disease is outstanding," says Dr. Neil Brooks, medical director of Vernon Manor Health Care Facility in Vernon, Conn. "This is a case in which the benefits are far greater than the harms."

"Statin drugs save lives," says Nissen. "What we are talking about is a subtle question of the starting dose and if each of the other drugs on the market is the same or not. They [statins] help more people than they hurt. These are extremely safe drugs."

Sixty-one countries have approved Crestor, with more than 2 million patients worldwide taking the drug