Pharmaceuticals Blog
Researcher takes heat after reporting truth on Trasylol
August 8th, 2007 by Todd HagemanTrasylol, manufactured by Bayer, is a drug given intravenously to prevent blood loss during heart bypass surgery. The drug was approved in 1993 to be used only on high-risk patients. In 1998, the FDA approved its use on all patients. Because doctors did not have to ask the patient’s permission to give the drug, few knew they received it.
Last year, Dr. Dennis Mangano, founder of the nonprofit Ischemia Research and Education Foundation, published a report in the New England Journal of Medicine that showed that Trasylol caused a higher risk of heart attacks, strokes and renal failure. He also found that there were lower-cost alternatives that did not have the same risk factors. Last fall, an FDA panel disregarded that report and voted unanimously to keep the medicine on the market. It issued an advisory instead.
Pharmalot reports that not long after the advisory was posted, Alexandar Walker of Harvard’s School of Public Health came forward and claimed that Bayer hired him six months before to review a database they compiled of 67,000 bypass patients who received Trasylol. He found the same results that Dr. Mangano found in his study. Bayer neglected to mention their study to the FDA.
Dr. Mangano recently told the St. Petersburg Times that he was surprised by the FDA’s harsh reception of his work.
