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    Thursday, December 23, 2004

    Misleading Ads: There is evidently some disagreement between the FDA and AstraZeneca about the safety of their new cholesterol-lowering drug, Crestor. The FDA has asked the company to withdraw advertisements which claim the FDA has :full confidence" in the drug's safety:

    AstraZeneca LP, the US arm of the London-based manufacturer, began the national advertising campaign after Food and Drug Administration whistle-blower David Graham named Crestor among five unsafe drugs the agency failed to yank from the market.

    'You can be assured that at AstraZeneca, patient safety is our number one priority,' began ads that ran Nov. 23 to Nov. 29 in such publications as the Los Angeles Times, The New York Times, USA Today, The Wall Street Journal, and The Washington Post.

    The print advertising added, in bold type, that the 'FDA has confidence in the safety and efficacy of Crestor.' According to the ad, FDA scientists responsible for drug approval 'publicly confirmed that Crestor is safe and effective.'

    In a letter posted on the FDA's website, the agency called that suggestion misleading. The letter quoted from an interview with Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research,, saying the FDA 'has been very concerned about Crestor since the day it was approved.'

    Well, I'll keep that in mind.

    UPDATE: Here's the FDA's Crestor letter. They have some considerable concerns about the 40mg dose of the drug:

    During the clinical trials, Crestor was shown to cause myopathy at the 40 mg dose. Prior to approval, the Agency recommended (and AstraZeneca agreed to) a risk management plan in which "[three] ongoing clinical studies with patients receiving long term treatment with 40 mg daily of Crestor...should have regular renal monitoring with urinalysis and serum creatinine measurements in order to better describe the clinical course of the renal findings."

    As a consequence of the risks identified with the 40 mg dose, the August 12, 2003 approval letter for Crestor refers to a premarketing submission of July 18, 2003 in which AstraZeneca describes voluntary special distribution measures for the 40 mg dose of Crestor "to ensure that the 40-mg dose is available only to patients who truly need this dose." The special distribution measures were undertaken by AstraZeneca because the Medical Review concluded that the 40 mg dose was only appropriate for "patients with severe hypercholesterolemia who have not responded adequately to all other available forms of therapy.

    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:

    · "A medication can be more effective and just as safe."

    This claim is misleading because it minimizes the risks associated with the 40 mg dose of Crestor. As discussed previously, these risks led to AstraZeneca agreeing to special distribution measures for Crestor 40 mg and to conduct three long-term post-marketing clinical trials to further assess the safety of the 40 mg dose. The PI reflects this concern, stating "The 40-mg dose of CRESTOR should be reserved for those patients who have not achieved goal LDL-C at 20 mg...." 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."

    Not long ago, AstraZeneca's CEO was blaming drug safety problems on the indiscriminate prescribing by primary care doctors. Looks like he's yet to take a good long look in the mirror.

    posted by Sydney on 12/23/2004 09:35:00 AM 0 comments


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