March 14, 2005

In Refusing to Ban Crestor, FDA Chooses Drug Company Over Safety

Statement of Sidney M. Wolfe, MD, Director, Public Citizen’s Health Research Group

The U.S. Food and Drug Administration’s (FDA) denial today of our petition to ban Crestor has a familiar ring in its similarity to the agency’s initial response to the dangers of many other drugs that were eventually banned. This response should give no comfort to either physicians or patients who are using or considering using Crestor. More than a year before Baycol was banned because of its uniquely high rate of rhabdomyolysis compared to other statins, the FDA was aware of this difference, as was the agency more than two years before the diabetes drug Rezulin was banned because of liver toxicity. Four years before Vioxx was banned, the FDA refused to even require a black box warning about known increased risk of heart attacks.

We are aware that because of its concerns about the increased rate of rhabdomyolysis and unique kidney toxicity of Crestor, the agency at least considered warning that the drug should be a last-choice drug for lowering cholesterol. Although this would not have been preferable to banning the drug, it would have been a much less reckless choice than merely allowing cosmetic labeling changes to be made.

• On page 16 of its response   to Public Citizen’s petition to ban Crestor, the agency admits that although “estimates of the reporting rate [for rhabdomyolysis] are higher than those of other marketed statins, the time period [post-Baycol] conceivably contributed to the enhanced reporting … because of publicity.” This is absurd since our recent analysis of the most recent year of rhabdomyolysis data on all of the statins, showing the rate for Crestor to be 6.2 times higher than other statins combined, covered a period from 10/03 through 9/04, during which the reporting of all statins would have been affected by the “Baycol effect.”
• While acknowledging (page 27) that as many as 15 cases of kidney failure with Crestor had a “history supporting possible direct causation by Crestor,” a similar analysis was not done for cases of renal failure reported with other statins. The agency also states (p. 30) that “neither does a review of the cases fully dispel concerns of possible renal effects of Crestor that might, in some instances, result in renal insufficiency or failure.” Thus, our earlier statement that the rate of such reports is much higher with Crestor compared to other statins is not rebutted.

Once again, when faced with concerns about the safety of a drug, the FDA has sided with the drug company, AstraZeneca, instead of the public. When Crestor is taken off the market, if not before, this will represent yet another blow to the agency’s badly tarnished reputation.

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