Texas Personal Injury Lawyers – Jim Adler & Associates – Blog

Drug Company Sales|Unsolved Mystery
The story of Trasylol isn’t an unsolved mystery anymore. But it reads a lot like a crime story about corporate greed, hidden evidence, and a whistle blower who exposed a major drug company that allegedly hid bad information about one of drugs to protect its profits. The company – Bayer AG – denies any improprieties and maintains that its drug is safe when used according to labeling.
Evidence hidden from FDA The Federal Drug Administration approved Trasylol in 1993 for use in patients at high risk of bleeding with some types of heart surgery. The FDA noted that kidney toxicity could be a problem when it approved the drug. What the FDA did not know then, according to a 60 Minutes report in February 2008, is that Trasylol’s manufacturer had evidence from a German doctor that it caused severe kidney damage in laboratory animals. The 60 Minutes report, One Thousand Lives A Month, featured the researcher, Dr. Juergen Fischer. He told CBS that Bayer AG, the drug’s manufacturer, wasn’t interested in examining “these side effects” when he revealed them to the company in the 1980s. By 1998, the FDA expanded the use of Trasylol, allowing it to be used in all heart bypass surgeries.
Study Says Many Deaths Linked to Trasylol
In 2006, a prominent American researcher, Dr. Dennis Mangano, the man who discovered that aspirin reduces the risk of heart attack, published a study in the New England of Medicine showing that Traslylol was severely damaged kidneys and causing thousands of death. By then, Bayer’s Trasylol sales had soared to $300 million a year.
Whistle Blower Reveals Trasylol Findings
eacting to the 2006 report, the FDA held hearings. Since the Mangano study was not conducted according to the strict medical protocols that the FDA favors – it tracked actual hospital records – the federal agency left the drug on the market.But the FDA didn’t get all the information about Trasylol at that hearing from senior Bayer AG representatives who knew that a study they commissioned confirmed Mangano’s findings. A week later the Harvard doctor who did the Bayer study went to the FDA and blew the whistle.
Trasylol Still Used
In November 2007, the FDA asked Bayer AG to remove the drug from the American market for safety reasons. But it is still available. The FDA suspension includes a “slow phase out of Trasylol from the marketplace to decrease the possibility of shortages of the alternative drugs,” according to a statement from an FDA spokesman in U.S. News & World Report. Bayer maintains that Trasylol ”has a favorable risk benefit profile when used according to labeling.”