Plus Comment by Vera Hassner Sharav
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP), www.ahrp.org
Bayer failed to report risks of drug
By Gardiner Harris
WASHINGTON Bayer, the German pharmaceutical giant, failed to reveal to U.S. regulators the results of a large study suggesting that a widely used heart-surgery medicine might increase the risks of death and stroke, the U.S. Food and Drug Administration has announced.
Bayer scientists even appeared at a public meeting called by the agency 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 FDA on Friday 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 reiterated previous warnings that Trasylol's use should be limited to patients in whom the risks of blood loss outweigh the drug's risks.
The disclosure comes exactly two years after Merck announced that it was withdrawing its arthritis drug, Vioxx, after a study showed that it doubled the risks of heart attacks. Since then, members of the U.S. Congress and even top scientific advisers have concluded that the food and drug agency 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 tests of their drugs on people that suggest that the drugs are either ineffective or dangerous. Some members of Congress have proposed legislation that would require that nearly all human drug trials be announced and their results disclosed publicly.
A top Food and Drug Administration official said the agency learned of the Trasylol study on Wednesday only after receiving 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 agency 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 at 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," Findlay said.
Doctors give Trasylol to patients before surgery to reduce the risks of blood loss, and it is needed 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, less-expensive drugs that can be used in Trasylol's place.
Still, the advisory panel concluded that Trasylol's risks are worth taking for some patients. Despite the results of the new study, Teerlink said that might still be true.
Comment by Vera Hassner Sharav
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP), www.ahrp.org
Failure to disclose study findings to the FDA is a federal crime.
So what is preventing the U.S. Department of Justice from prosecuting Bayer for manslaughter?
Executives of Enron, WorldCom (MCI), Global Crossing, Adelphia, Tyco et al were prosecuted and sentenced to prison.
Why are pharmaceutical giants whose repetitive crimes of concealment have resulted in hundreds of thousands of preventable deaths-allowed to continue to use their government license to engage in business as usual?
One primary reason-as confirmed in the scathing report by the Institute of Medicine-safety is not a priority for the FDA which consistently shields those whom FDA officials perceive as the agency's paying "clients." Whereas taxpayers are treated with lethal drugs bearing FDA's seal of approval, pharmaceutical and biotech companies receive the red carpet treatment—even when they are caught selling lethal drugs without warning.
The Times reports that despite Bayer's failure to reveal the results: "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 Times also reports: "Several members of the advisory committee that met last week said they were shocked that Bayer failed to inform them of the study."
About as "shocked" as Claude Reins was when told there was gambling in Casablanca!
FDA reviewing safety of Bayer heart-surgery drug / US Lawyers Assessing Trasylol Claims
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Prof. Juergen Junginger, designer, Krefeld,
Prof. Dr. Juergen Rochlitz, chemist, former member of the Bundestag, Burgwald
Wolfram Esche, attorney, Cologne
Dr. Sigrid Müller, pharmacologist, Bremen
Eva Bulling-Schroeter, member of the Bundestag, Berlin
Prof. Dr. Anton Schneider, biologist, Neubeuern
Dorothee Sölle, theologian, Hamburg (died 2003)
Dr. Janis Schmelzer, historian, Berlin
Dr. Erika Abczynski, pediatrician, Dormagen