FDA Stops Illegal Crestor Ads

Dec. 22, 2004

FDA Stops Illegal Crestor Ads

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

On November 24, 2004, I wrote to Acting FDA Commissioner Lester Crawford urging that the FDA stop illegal ads for the cholesterol-lowering drug, Crestor, being run by AstraZeneca. The AstraZeneca Web site stated [since removed] that “We have been assured today at senior levels in the FDA that there is no concern in relation to CRESTOR’s safety.” [1] In an advertisement, referring to the opinions of FDA scientists, the company stated that “the concerns that have been raised [by Dr. Graham about Crestor] have no medical or scientific basis.” [2]

In a letter to AstraZeneca posted on the FDA’s web site today[3]demanding that the company stop such ads, the agency has stated that:

The “patient safety” print ad [for Crestor] makes false or misleading safety claims that minimize the risks associated with Crestor, thereby suggesting that Crestor is safer than has been demonstrated by substantial evidence or substantial clinical experience. The print ad thus misbrands Crestor in violation of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 352 n); 21 CFR 202.1(e)(6)(i).

The FDA letter to AstraZeneca continues, stating that:

The “patient safety” print ad presents false or misleading safety claims that minimize the risks associated with Crestor. The ad is headlined “You can be assured that at AstraZeneca, patient safety is our number one priority” and seeks to assure readers that Crestor is “more effective and just as safe” as “the leading medications in its class.” These false or misleading claims include:

FDA is not aware of substantial evidence or substantial clinical experience demonstrating that all doses of Crestor are “just as safe” as other statins.

Similarly, we are concerned about the section of your ad entitled, “The FDA has confidence in the safety and efficacy of CRESTOR” in that it misleadingly suggests that the Agency does not believe that Crestor poses safety concerns. Specifically, your ad states:   “The scientists at the FDA who are responsible for the approval and ongoing review of CRESTOR have, as recently as last Friday, publicly confirmed that CRESTOR is safe and effective; and that the concerns that have been raised have no medical or scientific basis.”

The citation for this claim is “www.fda.gov accessed on 11/19/04.” There is, however, no statement on the website by FDA concluding that “the concerns [about Crestor] that have been raised have no medical or scientific basis.” In fact, recent public statements made by the Agency contradict that conclusion. For example, in an article entitled “Campaign Waged Against Crestor” appearing the previous week (on November 18, 2004) in the Washington Post, which discusses the safety concerns raised by the consumer advocacy group Public Citizen about Crestor, Dr. Steven Galson, Acting Director of the FDA’s Center for Drug Evaluation and Research is quoted as saying:   “[the Agency] has been very concerned about Crestor since the day it was approved, and we’ve been watching it very carefully.” Dr. Galson further stated that the Agency is “concerned about the same issues with Crestor as Public Citizen.”

The Division of Drug Marketing and Communication requests that AstraZeneca immediately cease the dissemination of violative promotional materials for Crestor such as those described above.”

Since, as the FDA has admitted in this letter to AstraZeneca, the agency “is not aware of substantial evidence or substantial clinical experience demonstrating that all doses of Crestor are ‘just as safe’ as other statins,” there is further reason for the FDA to act on our March 2004 petition and immediately ban Crestor.

To read Dr. Wolfe’s letter to the FDA regarding Crestor’s advertising, click here.

To read Dr. Wolfe’s letter to the FDA supplementing Public Citizen’s March petition, click here.

 


[1]AstraZeneca web site, accessed November 24, 2004. 

http://www.astrazeneca-us.com/modules/PRMS/display.asp?id=151528.

[2] New York Times, November 24, 2004, page A15.