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Report Faults Bayer on Baycol Withdrawal

Nov 22, 2004 | AP

New reports accuse another drug company of being too slow to pull a dangerous medication from the market and question the ability of the federal Food and Drug Administration to protect the public from such risks.

This time it's Baycol, a cholesterol-lowering statin that Bayer AG withdrew in 2001 after some who took it developed a severe and sometimes fatal muscle disorder. A new study found that the risks were far greater than had been believed.

The study concludes that today's top-selling statins are very safe, but could be risky when taken with other drugs called fibrates by older people with diabetes.

It also reveals that fibrates alone can be dangerous. These drugs lower triglycerides and often are taken by diabetics.

Six papers on the issue were to be released Monday and will be published Dec. 1 in the Journal of the American Medical Association. Its editors called for a new, independent office separate from the FDA to monitor drugs after they're on the market.

"It is unreasonable to expect that the same agency that was responsible for approval of drug licensing and labeling would also be committed to actively seek evidence to prove itself wrong," they write.

Merck & Co. and the FDA have been accused of moving too slowly to stop sales of the arthritis drug Vioxx, which Merck withdrew in September after revealing it raised the risk of heart attacks and strokes. Some scientists claim that pain killers similar to Vioxx, especially Pfizer Inc.'s Bextra, also carry risks.

On Thursday, Dr. David Graham, associate director of science in the FDA's Office of Drug Safety, told a Senate panel that the FDA was incapable of protecting the public, and that dangerous drugs are being sold now. Bextra and AstraZeneca PLC's statin, Crestor, were among the five he named.

Crestor wasn't part of the new study that Graham and nine other government and private scientists published Monday because the drug was only approved in August 2003 and their study started in 2001, just after Bayer withdrew Baycol.

They checked records from 11 large health insurance companies on more than 250,000 statin-users from 1998 to 2001. Statins lower LDL or "bad" cholesterol, and fibrates lower a different kind of fat in the blood, triglycerides. People often are prescribed both.

Those taking the top-selling statins Lipitor Pravachol and Zocor had an extremely low risk of the muscle disorder. But it was five times more common in people taking a fibrate, and an additional two-fold greater in people taking both types of drugs.

The risk with Baycol was 10 times higher than for other statins, and astronomical when it was combined with a fibrate: one out of 10 patients taking these for a year would have developed the dangerous side effect.

"I can't think of another drug safety combination where the level of risk is this high," Graham said.

Some popular brand names of fibrates are Abitrate, Atromid, Lopid and TriCor. As for Crestor, the newest statin on the market, its label already warns that people over 65 and those with diabetes or kidney problems are at greater risk of the muscle disorder.

Bayer added a similar warning to Baycol's label but not for more than a year and a half after it had evidence of the risk, Dr. Bruce Psaty of the University of Washington in Seattle and three other drug safety experts write in another article in the medical journal.

As proof, they cited published studies on Baycol and internal company documents that have become public as part of a lawsuit in Texas against Bayer over the drug.

There is a "striking asymmetry" between what the company knew within three months of putting Baycol on the market and what it told the public and physicians, they write. Companies have financial motives to keep such damaging information quiet, and should not be in charge of monitoring the safety of their own drugs an independent group needs to do this, they write.

A lawyer for Bayer, Joseph Piorkowski, wrote a response noting that Psaty and another author have been experts for people who unsuccessfully sued Bayer over Baycol. He also defended the company's actions, saying it labeled and disclosed risks appropriately.

In a separate article, Dr. Brian Strom of the University of Pennsylvania acknowledged the conflict of interest in allowing drug companies to monitor their own products, but said the solution is more support for the FDA and its work not another oversight agency.

Graham, the FDA whistleblower, said people taking statins or fibrates should watch for signs of the life-threatening muscle disorder, which can be treated if caught early. Patients should immediately tell doctors of any muscle pain, weakness, fever, dark urine, nausea or vomiting.


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