If you own a television, and watch it even intermittently no doubt you’ve seen the charming ads for Crestor, a cholesterol lowering medication produced by AstraZeneca, a multi-national pharmaceutical company based in the UK.  

The ads employ the voice of Patrick Stewart (Capt. Jean-Luc Picard to Star Trek fans) reciting amusing rhymes after the fashion of Dr. Seuss about the benefits of Crestor as the cholesterol lowering medicine of choice.  Essentially the ads claim Crestor is the most effective cholesterol reducer on the market (a claim the FDA has called into doubt by the way).

What the ads don’t tell you (naturally enough) is that the risk of death from using Crestor is twice that of other cholesterol reducing drugs on the market.

More after the break . . .

AstraZeneca said it strongly disagreed with the conclusions of the latest research, which were published in the American Heart Association’s journal Circulation.

Dr. Richard Karas of the Tufts-New England Medical Center in Boston, who led the study, said his team found a rate of 28 adverse events per million prescriptions of Crestor.

That was about 2.2 times more than the adverse events seen with Merck and Co’s Zocor and 6.8 times higher than for Pfizer Inc’s Lipitor.

There were six deaths per million prescriptions on Crestor as compared to three per million for Zocor, one per million with Bristol Myers Squibb’s Pravachol and two per million for Lipitor.

And this wan’t the first time that Crestor has come under fire regarding safety concerns.  Back in December, 2004, concern about the drug’s safety were enough for one Democratic Congressman, Henry Waxman to request that the FDA take action:

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.”

Nonetheless, the FDA has not chosen to take any action regarding Crestor.  Indeed, it lends  AstraZeneca and Crestor the full weight of it’s support despite an ever-increasing evidence of problems with the drug:

New research seems to challenge a Food and Drug Administration decision not to pull the cholesterol-lowering drug Crestor off the market, with data showing it causes more kidney and muscle problems than rival medications.

. . . FDA spokeswoman Laura Alvey said that the new analysis yielded no new information. “We haven’t found any convincing evidence that Crestor poses any more of a risk than the other statins,” she said.

So for all you AstraZeneca shareholders out there, blow a big wet smoochy toward the FDA today.  A better regulatory friend would be hard to find.  

As for Crestor consumers . . .

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