PFPC Daily - December 12, 2004

Crestor ads draw fire; FDA could act

USA TODAY - December 8, 2004

By Donna Leinwand

WASHINGTON — A House Democrat has asked the Food and Drug
Administration to crack down on the maker of the cholesterol-lowering
drug Crestor for what he calls misleading advertising on its Web site
and in national newspapers.

Crestor is one of five drugs named as potentially hazardous by FDA
drug safety officer David Graham in testimony to Congress.
AstraZeneca, which manufactures and markets Crestor, responded with
full-page advertisements in national and regional publications,
including The Wall Street Journal, The Washington Post,The New York
Times, and USA TODAY that said, "The FDA has confidence in the safety
and efficacy of CRESTOR."

Rep. Henry Waxman, D-Calif., the ranking Democrat on the House
Committee on Government Reform, said in a letter to the FDA on Friday
that AstraZeneca's advertising conflicts with the FDA's public
statements about the drug. He asked the FDA to review the company's
statements and order them to post a correction if the statements are
incorrect.

"Either AstraZeneca is misleading the public about Crestor's safety,
or FDA officials are giving the company private assurances that
conflict with the agency's public position," Waxman wrote. He said
the company's statement on its Web site that it had been assured that
senior-level FDA officials have "no concern in relation to Crestor's
safety" appears to conflict with FDA statements.

Waxman pointed to one newspaper interview in which Steven Galson,
acting director of the FDA's Center for Drug Evaluation and Research,
said the agency "had been very concerned about Crestor since the day
it was approved, and we've been watching it very carefully."

But Galson also said in a written statement following the
congressional hearing that Graham's testimony didn't reflect the
FDA's views and that all five of the drugs Graham mentioned are
currently approved as "safe and effective" for use in the USA.

Waxman's letter echoes a similar letter sent in November by consumer
activist group Public Citizen, which claims the drug is unsafe and
should be banned from the market.

FDA spokeswoman Kathleen Quinn acknowledged the agency has received
Waxman's letter. The FDA "takes his concerns seriously and will
respond promptly," she said.

AstraZeneca stands by its advertising, spokeswoman Emily Denney said.
"It is consistent with what has been communicated to us by the FDA,"
she said. She said the ad, which ran for two or three days, was
essential to correct misinformation that emerged during the
congressional testimony. She said the company was deluged with calls
from doctors and patients.

Crestor, approved in August 2003, is a "statin" drug prescribed to
lower cholesterol levels. The FDA issued a health advisory this year
after AstraZeneca changed the label on Crestor for the European Union
to include a warning about the risk of developing a muscle problem
called rhabdomyolysis. Although the U.S. label already noted the
risk, the FDA said it would alert physicians to be especially careful
when prescribing the drug.

SOURCE:
http://www.usatoday.com/news/health/2004-12-08-crestor-usat_x.htm