An Estimated 22,000 Lives Could Have Been Saved If Trasylol Removed Earlier
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In a 2006 study, Trasylol, a drug made by Bayer for use in operating rooms to control bleeding, was shown to have contributed to the deaths of thousands of patients over a fourteen-year period. The Canadian government conducted a clinical trial on the drug that had to be stopped due to the deaths of so many patients. There was concern long before the trial as well. After major studies identified the problem, it took Bayer and the Food and Drug Administration (FDA) nearly two years to get the drug off the shelves. During these two years, Trasylol contributed to the loss of about one thousand lives a month. A leading medical researcher finished the largest study on Trasylol ever, conducted of over 5,065 patients in 17 countries. This study showed a very important correlation between Trasylol use and kidney failure requiring dialysis. It also showed an increasing death rate in the patients using Trasylol. http://www.cbsnews.com/stories/2008/02/14/60minutes/main3831900_page4.shtml
Since the 1980s, there has been controversy over the safety of Trasylol. Animals given the drug were said to have suffered severe kidney failure. The doctor who oversaw the experiment on the animals said Bayer, when told about the side effect, was not interested in reexamining the drug since it was making the company hundreds of millions of dollars. When one of the nation's leading heart surgeons conducted his own study on the drug in 1992, thirteen of the twenty people he gave Trasylol had problems with their kidneys after their surgery. The FDA, in the case of Trasylol, did not certify the drug as being safe. Instead, it certified the drug as being effective in controlling bleeding. Until 2006, there was not a large enough study to determine whether kidney failure was a problem with Trasylol so the FDA and Bayer never had a reason to pull it from the shelves. In 2006, the Mangano study claimed thousands of people died due to the drug, which led to the FDA issuing an advisory to doctors, although the administration did not plan to have a meeting about the drug for eight months. Bayer tried to have its own study refuting that of its criticizers, however, the results of this study were very similar.
When Mangano asked the FDA advisory committee to review the drug due to the dangerous risks he found, Bayer did not disclose that they too had heard about these risks from the results of their own study. Bayer, however, claims the data was not ready for review. Because the FDA did not have the results of Bayer's study, they voted against Mangano's study and kept the drug on the market. The doctor who conducted the study for Bayer told the FDA about his findings that went unheard at the committee hearing. However, it took the FDA a year to consider the results of the hidden Bayer study. If Trasylol had been removed from the market when Mangano's research was made public, it is estimated that 22,000 lives could have been saved. http://www.cbsnews.com/stories/2008/02/14/60minutes/main3831900_page4.shtml
