F.D.A. Says Bayer Failed to Reveal Drug Risk Study
 

By GARDINER HARRIS
WASHINGTON, Sept. 29 — Bayer A.G., the German pharmaceutical giant, failed to reveal to federal drug officials the results of a large study suggesting that a widely used heart-surgery medicine might increase the risks of death and stroke, the Food and Drug Administration announced Friday.

Bayer scientists even appeared at a public meeting called by the F.D.A. on Sept. 21 to discuss the possibility that the drug, Trasylol, might have serious risks. But they did not mention the study or its worrisome results.

In a highly unusual move, the food and drug agency released a public health advisory saying it had learned of the study’s existence only on Wednesday. Preliminary results of the study demonstrate “that use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes,” the advisory said.

Nevertheless, the agency did not change its advice about whether patients should be given the drug. Instead, it restated previous warnings that Trasylol’s use should be limited to patients in whom the risks of blood loss outweighed the drug’s risks.

The disclosure comes exactly two years after Merck announced it was withdrawing its arthritis drug, Vioxx, after a study showed that it doubled the risks of heart attacks. Since then, members of Congress and even top scientific advisers have concluded that the F.D.A. lacks the regulatory authority and the money needed to detect and protect against drug dangers.

Drug companies have also been sharply criticized for failing to make public the results of some human trials of their drugs that suggest that the drugs are either ineffective or dangerous. Some lawmakers have proposed legislation that would require that nearly all human drug trials must be announced and their results disclosed publicly.

A top F.D.A. official said the agency learned of the Trasylol study on Wednesday only after a getting a tip from a researcher involved in it. The official insisted on anonymity because of the sensitive nature of the information.

In a written statement, Bayer said “that it mistakenly did not inform” the F.D.A. of the study and added, “This data was not shared immediately with the agency because it was preliminary in nature.”

Staci Gouveia, a Bayer spokeswoman, said the company nonetheless stood behind the safety of Trasylol, which has become one of Bayer’s fastest sellers. Sales last year were $200 million and were expected to nearly triple this year.

Several members of the advisory committee that met last week said they were shocked that Bayer failed to inform them of the study.

“For them not to mention that it was under way, that it was being analyzed or that results were available is appalling and will do significant harm to their reputation for transparency,” said Dr. John Teerlink, an associate professor of medicine at the University of California, San Francisco, and a member of the advisory committee.

Steven Findlay, a health care analyst at Consumers Union and another committee member, said the agency needed to investigate whether Bayer knowingly withheld the information from the advisory committee.

“The safety of this drug is called into further question now,” Mr. Findlay said.

Doctors give Trasylol to patients before surgery to reduce the risks of blood loss. It can also reduce the need for transfusions in patients undergoing heart bypass surgery. Trasylol, also known as aprotinin, has been on the market for 13 years.

But two recent studies suggested that the drug might have serious risks. One of the articles, published in January in The New England Journal of Medicine, found that the drug increases the risks of kidney failure, heart attack and stroke. The study concluded that halting the drug’s use would prevent 10,000 to 11,000 cases of kidney failure a year and save more than $1 billion a year in dialysis costs, as well as nearly $250 million spent on the drug itself.

There are other, cheaper drugs that can be used in Trasylol’s place.

Still, the advisory panel concluded that Trasylol’s risks were worth taking in some patients. Dr. Teerlink said that despite the results of the new study, that might still be true.

Bayer’s study was performed by a contract research organization. But Bayer did not inform the F.D.A. that the study was being done, even though that is routine practice.

It examined hospital records of 67,000 patients, 30,000 of whom received Trasylol. The rest got other drugs. It concluded that the patients given Trasylol were at greater risk.

Such studies, however, are fraught with statistical and other problems. Patients given Trasylol may have been sicker than those given other drugs. Their worse outcomes would be explained not by problems with Trasylol but by their own illness.

Susan Bro, an F.D.A. spokeswoman, said it was evaluating the new study and would decide soon whether the results merit changing the agency’s advice about use of the drug.

“It is regrettable that the F.D.A. advisory board did not have the benefit of a frank scientific dialogue based on the totality of available data,” she said.

Senator Charles E. Grassley, Republican of Iowa and chairman of the Senate Finance Committee and a longtime critic of the F.D.A., said Bayer’s behavior proved that the agency was largely toothless.

“The remedy is mandatory reporting of all clinical trials and real teeth for the F.D.A. to do its job in holding drug companies accountable,” Mr. Grassley said.