FDA investigating delay in telling U.S. side effects of drug
Bayer AG said it failed to tell U.S. regulators about a study showing deadly side effects from a drug to control bleeding because two employees didn’t inform supervisors the report had been completed.
Bayer, Germany’s largest drugmaker, has suspended the two “senior” employees while an outside lawyer, former White House Counsel Fred Fielding, investigates the lapse, a company spokeswoman said Friday. The employees worked in Germany and Bayer believes they are the only company officials who knew the study had been finished, the spokeswoman, Staci Gouveia, said.
“Bayer believes this was a serious error in judgment on the part of the two individuals,” Gouveia said in an interview.
The FDA has been investigating why Bayer didn’t provide the results of a 67,000-patient study analyzing the drug, Trasylol, before a Sept. 21 agency advisory committee meeting reviewing the drug’s safety. Bayer later provided the agency with the study after a researcher working for a company hired by Bayer to complete the report alerted the FDA.
Bayer said last month the omission was a mistake. The study confirmed an earlier trial showing that the Leverkusen, Germany-based company’s drug, used on patients undergoing heart bypass surgery, increased the risk of kidney failure, heart attacks and strokes.
Gouveia declined to identify the two employees, who worked in the company’s global drug safety group and were suspended effective Oct. 2.
The Bayer employees didn’t disclose the report because they viewed it as preliminary and had “significant” concerns about the methodology, said Gouveia. The employees completed a list of questions for the study’s authors, she said.
Bayer said the employees received the report on Sept. 14 from i3 Drug Safety, a private clinical research company owned by Minnetonka, Minn.-based UnitedHealth Group Inc., the largest U.S. health insurer.
A member of the FDA advisory panel, Steven Findlay, a health-care analyst with Consumers Union, said he doubted only two Bayer employees knew of the study’s completion.
“It just strains credulity that only they would know,” Findlay said in an interview.
Bayer officials gave a presentation to the advisory committee and Findlay said he’d be surprised if they didn’t inquire about the status of the study beforehand. Bayer has said that employees making the presentation didn’t know the study was done.
The FDA had convened the advisory panel of doctors and other experts after a report published earlier this year showed the drug had a higher risk of toxicity than other treatments. The FDA says it also called the panel together because the number of deaths that may be linked to Trasylol rose to 10 last year from four in 2004.
The FDA has been reviewing the new study and is considering whether to hold a new advisory committee meeting.
Fielding, with the law firm Wiley Rein & Fielding LLP in Washington, will investigate what happened and make recommendations for any improvements in the company’s operations that may be needed, Gouveia said. Fielding served in the Reagan White House and was more recently a member of the commission that studied the Sept. 11, 2001, terrorist attacks.
Trasylol was approved for U.S. marketing in 1993 to reduce the need for blood transfusions in bypass surgeries. About 4.3 million patients have been given the injectable drug, according to Bayer, which says the treatment generated about $293 million in sales last year, making it the company’s 11th biggest-selling therapy. Revenue declined 25 percent in the first half of 2006 from a year earlier, according to Bayer.
Bayer shares rose 10 cents to 40.07 euros in Frankfurt. The stock has increased 35 percent during the past 12 months.