Cholesterol Killer - no, not food, the statin drugs....

Baycol's risks possibly concealed

By Alan Zarembo

LOS ANGELES TIMES


Another pharmaceutical company may have concealed safety information about a dangerous drug, this time Bayer and its once-popular cholesterol medication Baycol, according to a report in a prominent medical journal.

Baycol was pulled from the market in 2001, but an analysis published Monday in the Journal of the American Medical Association argues that there were strong indications of its dangers three months after the drug's introduction in 1998.

The report adds to concerns that the FDA's drug monitoring system is too lax. The FDA is being criticized for its handling of Vioxx, the Arthritis drug that remained on the market after concerns were raised that it increased the risk of heart attacks and strokes.

Its manufacturer, Merck & Co., pulled Vioxx off the market in September.

Baycol belongs to a class of cholesterol-lowering drugs known as statins, which have been shown to reduce the risk of heart attacks. Those drugs have been linked to a toxic muscle degeneration known as rhabdomyolysis, which can cause kidney problems and death.

Baycol, by far, had the highest rate of rhabdomyolysis of any statin, said Dr. Bruce Psaty, a professor of medicine and epidemiology at the University of Washington and co-author of the report.

In a response published in the same issue of JAMA, a lawyer for Bayer, Joseph Piorkowski, questions the objectivity of the report's authors, who served as expert witnesses in lawsuits against the company.

He argues that muscle degeneration is a known risk of all statins, that FDA surveillance has worked effectively and that the company's conduct "was responsible, appropriate and consistently motivated by concern about the safety and welfare of patients."

The dangers of Baycol cast suspicion over all statins, but a separate study published in the same issue of JAMA analyzes data from 250,000 patients who took statins between 1998 and 2001 and shows that three of the most common -- Lipitor, Pravachol and Zocor -- proved to be relatively safe.

The risk of rhabdomyolysis rose slightly when combined with medications known as fibrates, which lower triglycerides and are often prescribed in conjunction with statins.

Baycol, taken alone, posed 10 times the risk of other statins. When taken with fibrates, the danger was enormous: 10 percent of patients got the muscle disorder.

The study was led by Dr. David Graham, the FDA scientist who told a Senate panel last week that his agency was failing to monitor the safety of drugs it approved.

Dr. Benjamin Ansell, co-director of the cholesterol-management program at UCLA, said the risk posed by statins was far outweighed by their benefits." More people die every month from aspirin, which is considered to be relatively safe, than have ever died from the statins," he said.

During clinical trials to win FDA approval for Baycol, there were no signs of serious side effects. When the drug was released in February 1998, it carried a standard warning that statins have been linked to muscle degeneration.

In the first three months of sales, though, seven cases of rhabdomyolysis were collected through the FDA's adverse-event reporting system. Six of the patients had also been taking a fibrate, according to Psaty.

Psaty, whose analysis was partially based on internal Bayer documents made public during a lawsuit, said the six cases should have been a serious warning.

An editorial in the same issue of JAMA questions the FDA's system of monitoring drug safety.

The editors say the FDA relies too much on the drug companies to collect information about dangerous side effects of their products. They support calls for an independent body responsible for surveillance of drugs on the market.

http://www.contracostatimes.com/mld/cctimes/living/health/10252702.htm?1c

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