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Cases against Bayer for wrongful death, strokes, and kidney failure attributable to Trasylol.

DTrasylol Study Results Prove Damning For Bayer By Anne Urda, anne.urda@portfoliomedia.comPortfolio Media, New York (February 21,
2008)

The blows keep on coming for Bayer AG, with the full study on the pharmaceutical giant's blood-clotting drug Trasylol lending more weight to preliminary conclusions that the medication leads to kidney failure and an increased chance of death.On Thursday, the New England Journal of Medicine was expected to publish for the first time the full results of the Bayer-commissioned 2006 Trasylol study, less than a week after a researcher alleged that an estimated 22,000 lives could have been saved if the health care company had come clean earlier about the drug's potentially fatal problems.Plaintiffs attorneys immediately seized upon the news, which they believe will help to bolster their mounting product liability case against Bayer."

These findings should further educate the public about Trasylol's(R) dangers, and open the door for victims, and those who don't realize they are victims, to receive remuneration for their injuries," said Anapol Schwartz attorney James Ronca. "Again, we have another example of the FDA not protecting the public - and the safety of individuals taking a back seat to company profits."Such words echo the sentiments of Dr. Dennis Mangano, who claimed in a TV interview on Sunday that thousands of people might not have died if Bayer had been honest with the agency about the results of the January 2006 study he conducted, which revealed widespread problems with Trasylol."

There were approximately 431,000 patients who received the drug," Mangano said in the segment, which aired on CBS' "60 Minutes." As I calculated, 22,000 lives could have been saved. It's about a thousand lives per month."A cloud of suspicion has surrounded Trasylol for years. Bayer only recently agreed to suspend worldwide marketing of the drug after a Canadian study pointed to an increased risk of death associated with the medication.The U.S. Food and Drug Administration requested the suspension in November based on the "serious nature" of the outcomes suggested by the study. The agency had been notified in October that researchers with the Ottawa Health Institute had put the brakes on a study of Trasylol because the drug appeared to increase the risk of death compared to two other anti-fibrinolytic drugs used in the review.Anti-fibrinolytic drugs help slow the breakdown of blood clots and subsequent excessive bleeding.

Trasylol is generally used to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery.The preliminary data from the terminated study also suggested that fewer patients receiving the drug experienced serious bleeding events.The FDA has been eyeing Trasylol since January 2006, when it began conducting a safety review of the drug after two published research studies showed patients had greater chances of kidney failure and dysfunction, heart attacks and strokes after taking the drug.The agency held a public meeting in September 2006 to discuss the safety and overall risk-benefit profile for Trasylol. It discussed the findings from the two published observational studies, a safety review by Bayer and the FDA review of its own post-marketing database.

The advisory panel recommended to the FDA that Bayer didn't need to toughen its warning to doctors about the drug.However, the FDA was contacted just days later by a professor at Harvard's School of Public Health who said the agency had overlooked a 67,000-patient study he helped conduct at Bayer's request.The study reviewed an extensive database of bypass patients and compared the side effects of all drugs used to stem bleeding, including Trasylol. According to Bayer, it got the results of the study one week before the FDA meeting to consider new warnings.Nevertheless, the data were never presented. Bayer claimed it wasn't aware the final results were ready and that researchers were still waiting for answers to follow-up questions when the FDA advisory committee met.In October 2006, the FDA accused Bayer of failing to inform the agency of the study.Bayer acknowledged the omission and said it was a mistake.

The information, the company said, was "not shared immediately with the agency because it was preliminary in nature and raised significant questions on the study population, outcomes and methodology."The company also quickly laid blame on two rogue researchers who it said withheld the additional information about Trasylol's side effects from the evidence presented to the FDA.Trasylol, which is made from the lung tissue of cattle, generated about $293 million in sales in 2005 alone, making it one of the company's top-selling drugs. In late 2005, Bayer forecast the drug would eventually generate as much as $600 million per year.--Additional reporting by Shannon Henson and Erin Marie Daly All Content Copyright 2007, Portfolio Media, Inc.