|The FDA letter cites one TV spot and three print ads for Crestor.
The letter, from the FDA's Division of Drug Marketing, Advertising and Communications, was sent to Dr. Mark R. Szewczak, director of promotional regulatory affairs for Wilmington, Del.-based AstraZeneca.
TV, print ads
The warning letter cites one TV spot and three print ads, all from Quantum Group, Parsippany, N.J., the WPP Group agency that handles Crestor. All the ads are comparative, citing results from testing last year called the STELLAR study, in which Crestor was compared to competitors Lipitor, Pravachol and Zocor. The TV ad, in particular, stated: "All cholesterol drugs simply aren’t the same. When Crestor performed in a head to head test its lowering effect was clearly the best."
But the FDA said the commercial's presentation was misleading because the claim "relies solely on data that are not relevant to comparisons of the drugs such as most common dose or starting dose, while ignoring data that do not support the claim of superiority made in the ads."
Not superior to rival
The FDA went on to say, "Specifically, the comparison with Lipitor is misleading because it suggests that Crestor is superior to Lipitor when in fact none of the approved doses of Crestor was significantly superior to 80 mg of Lipitor in the STELLAR study."
The FDA requested AstraZeneca cease dissemination of the ads and that it respond by March 22. The drug company could not be reached for comment this morning and did not provide a statement on its Web site.
FDA rejects drug ban
Ironically, the FDA supported Crestor yesterday when it rejected a petition from the Washington, D.C.-based consumer group Public Citizen to ban the drug. Dr. Sidney M. Wolfe, director of Public Citizen's Health Research Group, has been a longtime critic of Crestor, saying the drug has more dangerous side effects than its competitors. The side effects include kidney damage and a rare muscle-deteriorating disease.
But the FDA, in a 36-page response to Public Citizen, said Crestor "does not pose a risk of muscle toxicity greater than that of other approved statins," and that "there is no convincing evidence that Crestor poses a risk of serious [kidney] injury."
AstraZeneca did respond to this FDA ruling with a statement from David Brennan, president-CEO of AstraZeneca's U.S. operations.
"Patient safety is our top priority and the FDA's rejection of Public Citizen's petition should reassure the millions of people who have been unnecessarily alarmed by [Public Citizen's] allegations," Mr. Brennan said.
Dr. Wolfe said the FDA's ruling "should give no comfort to either physicians or patients who are using or considering using Crestor." The decision, he said, had a "familiar ring in its similarity to the agency's initial response to the dangers of many other drugs that were eventually banned."