and again, Crestor

“Watchdog wants Crestor probe”

Bloomberg News - August 4, 2004

Public Citizen says AstraZeneca delayed reports of complications, wants FDA to open investigation

By KERRY DOOLEY

A consumer advocacy group accused AstraZeneca on Tuesday of delaying reports to U.S. regulators about 23 cases of serious complications in people taking its Crestor cholesterol drug.

Public Citizen asked the Food and Drug Administration for a criminal probe of what it said were delays of as much as 97 days in making reports. These include four U.S. cases of kidney failure or damage linked to destruction of muscle cells.

"We continue to urge the prompt removal of this uniquely dangerous drug from the market and your investigation of AstraZeneca is quite likely to uncover further reasons to do so," Sidney Wolfe, director of Public Citizen's Health Research Group, said in a letter to the FDA.

AstraZeneca spokeswoman Edel McCaffrey called the accusations "false and misleading." AstraZeneca, which is based in London, has its U.S. headquarters in Fairfax and employs about 4,800 people in Delaware.

Mary Parks, deputy director of the FDA's unit that regulates cholesterol medicines, said the FDA would consider the allegations made by Public Citizen and, if necessary, take appropriate action. She noted that AstraZeneca has been very cooperative in working with the agency.

The FDA requires companies to report within 15 days when they hear of cases of serious complications in people taking their drugs. Wolfe said AstraZeneca failed to meet that deadline in some cases, mak-ing Crestor appear safer than it is.

McCaffrey denied the allegations. "The company has operated diligently in accordance with the strict reporting procedures of the FDA," McCaffrey said.

Crestor is part of a class of cholesterol-lowering medicines known as statins, which includes Pfizer Inc.'s Lipitor. Statins are associated with rare cases of a breakdown of muscle cells, called rhabdomyolysis. The condition can cause kidney damage and death when it overwhelms that organ's ability to clean up the debris left by dead muscle cells.

Bayer AG had to take its Baycol statin drug off the market in 2001 because of deaths and patient injuries linked to rhabdomyolysis.

AstraZeneca chief executive Sir Tom McKillop predicts Crestor can grab about 20 percent of the $20 billion cholesterol market, and his company needs it to make up for slowing sales of older drugs. The FDA cleared Crestor for marketing last August after delaying approval by a year as it sought more information on the drug's risk-benefit ratio. More than 2.8 million people have been treated with Crestor, AstraZeneca said.

Public Citizen, founded by U.S. presidential candidate Ralph Nader, asked the FDA not to approve Crestor, and earlier this year wrote letters urging the agency to pull the drug from the market.

SOURCE:
http://www.delawareonline.com/newsjournal/business/2 004/08/04watchdogwantscr.html