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More information on rosuvastatin (Crestor)

Letter Urging Action on AstraZeneca's Misleading Crestor Advertising

November 24, 2004

Lester Crawford, DVM, Acting Commissioner
Food and Drug Administration
5600 Fishers Lane
Rockville, MD  20854

Dear Dr. Crawford,

I am writing to you to urge you to force AstraZeneca to immediately stop a false and misleading advertising campaign in which the company is claiming that there is no FDA concern about the safety of Crestor, its heavily advertised cholesterol-lowering drug.

In March of this year, Public Citizen’s Health Research Group petitioned the FDA to ban Crestor (rosuvastatin) because the dual safety issues of its unique kidney-damaging properties and because it appears to have a higher rate of the life-threatening breakdown of muscle, rhabdomyolysis, than the other statins now on the market.

Last week, the Acting Director of FDA’s Center for Drug Evaluation and Research (CDER), Dr. Steven Galson, was quoted as saying that the agency "has been very concerned about Crestor since the day it was approved, and we've been watching it very carefully." He said the agency is "concerned about the same issues with Crestor as Public Citizen."[1]

In large newspaper advertisements running this week and on its Web site — in response to Crestor being identified by an FDA Drug Safety official, Dr. David Graham at a Senate hearing on November 18th as one of five currently marketed drugs about which there were safety concerns — AstraZeneca has made false and or misleading statements about the FDA’s current opinion about Crestor:

The Web site states that “AstraZeneca has followed up these remarks with speed and diligence.   We have been assured today at senior levels in the FDA that there is no concern in relation to CRESTOR’s safety.”[2] 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.”[3]

This statement constitutes false and or misleading advertising that violates FDA laws and regulations since it clearly misrepresents the statements of the FDA’s top drug official, Dr. Galson, and, certainly, many other FDA officials. I urge that the FDA immediately stop AstraZeneca from running this or any other misleading advertising about Crestor.

Sincerely,

Sidney M. Wolfe, M.D.
Director
Public Citizen's Health Research Group


[1] Washington Post, November 18, 2004.

[2] AstraZeneca web site, accessed November 24, 2004. http://www.astrazeneca-us.com/modules/PRMS/display.asp?id=151528. Now available at: http://web.archive.org/web/20041119162215/http://www.astrazeneca-us.com/modules/PRMS/display.asp?id=151528.

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

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