WORST PILLS-STILL CRESTOR

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Study Suggests Use Only as Last Resort

By Marc Kaufman

Washington Post Staff Writer

Tuesday, May 24, 2005; Page A01

The powerful cholesterol-lowering drug Crestor is significantly more

likely than other statins to cause muscle deterioration that can lead

to kidney disease and failure, according to a study in the American

Heart Association's journal, Circulation.

The conclusion is at odds with the most recent recommendation of the

Food and Drug Administration, which in March rejected a citizen's

petition to remove Crestor from the market. At the time, the FDA said

Crestor, which has been aggressively marketed by AstraZeneca LP,

appeared to be no more dangerous than other statins for most people.

Based on the number of side effects reported to the FDA, however, the

researchers said yesterday that Crestor was two to six times as

likely to cause complications over a one-year period as three other

statins on the market.

Although the number of serious side effects reported by Crestor users

was small, the study authors said the higher rate convinced them that

doctors should try their patients on other statins and only turn to

Crestor as a last resort.

The study " raises concerns about the safety of this drug at the range

of doses used in common clinical practice, " the study concludes. " It

would seem prudent at the current time for health care providers to

consider other statins as first-line therapy. "

AstraZeneca defended its billion-dollar-a-year drug, saying " we

strongly disagree with the conclusions of this study. " In a

statement, the company said the FDA's voluntary system for soliciting

reports of complications, called " adverse events, " does not confirm

the accuracy of the accounts it gets and so cannot be used to

determine a drug's risks.

The company cited the FDA's recent conclusion that based on all the

evidence available, Crestor does not pose an unacceptable

risk. " AstraZeneca again reaffirms that the safety profile of Crestor

is in line with other marketed statins, and is a highly effective

cholesterol-lowering therapy, " it said.

With drug safety an increasingly hot topic with the public, doctors

and members of Congress, the Circulation paper quickly became a new

source of controversy.

Sidney M. Wolfe of Public Citizen Health Research Group, who filed

the petition rejected by the FDA, said the study confirmed his

conclusions.

" This should be very embarrassing to the FDA, " Wolfe said. He said

that unlike the arthritis painkillers Vioxx and Bextra, which were

recently taken off the market because of harmful side effects,

Crestor's potential to cause muscle and kidney damage was known

before the drug was approved.

" Short of having the drug taken off the market, I don't think that

anything could contribute to the end of a drug more than this paper, "

Wolfe said.

M. Grundy, a University of Texas Southwestern Medical Center

researcher long associated with efforts to reduce cholesterol levels

to prevent heart disease, defended the drug. Grundy, in a commentary

accompanying the research paper, said he was not convinced that the

risks from the higher potency of Crestor outweighed its possible

benefits to patients with especially high cholesterol levels.

The American Heart Association -- which did not take a position on

either the study or the accompanying commentary -- held a

teleconference yesterday to discuss the study and its view that

patients should continue on whatever statins their doctors prescribe.

Grundy said he would prescribe Crestor now as readily as any other

statin. But H. Karas of Tufts-New England Medical Center,

lead author of the Circulation paper, said he would recommend Crestor

only as a last resort.

Both Karas and Grundy have received research contracts and speaking

fees from statin makers, including AstraZeneca. The heart association

also receives considerable financial support from drug companies.

Crestor, which was approved by the FDA in 2003, is agreed to be the

most potent statin on the market. Its higher strength, however, does

not make a dramatic difference in studies. While statins such as

Lipitor, Zocor and Pravachol lower LDL -- or harmful -- cholesterol

by 50 to 55 percent, Crestor decreases it by 55 to 60 percent, said

Grundy and Karas.

In the new study, doctors of patients taking Crestor were

significantly more likely to report complications of kidney disease

and rhabdomylosis, a muscle deterioration that releases toxins into

the blood that can cause renal failure. The overall number was small -

- 145 muscle or kidney problems out of 5.2 million prescriptions

during the drug's first year on the market -- but the number was

substantially higher than for other statins.

In 2001, the FDA took Baycol, a considerably more powerful statin

than Crestor, off the market because of similar side effects. In a

congressional hearing last December, FDA drug safety officer and

whistle-blower Graham identified Crestor as one of five drugs

now on the market that he believed posed serious safety problems that

were not balanced by their benefits.

The FDA yesterday referred callers to its March conclusions that

Crestor is no more hazardous than other statins.