I was watching CBS Televesion’s 60 Minutes program tonight. It focused on the drug Trasylol developed by Bayer Pharmaceuticals Corporation. Trasylol (aprontinin), which was commonly prescribed to patients undergoing heart surgery, was released in 1993 following approval from FDA. However in Jan 2006, an independent study on 5000 Trasylol users worldwide by Dr. Mangano found the severity of Trasylol failure risk and other serious side effects. Same dangers were confirmed by a Harvard researcher who was hired by the Bayer to conduct research on Trasylol. In September 2006, during an FDA advisory panel meeting, when Dr. Mangano presented his work on Trasylo and suggested the panel to stop using the drug; however Bayer did not disclose the negative result they already got from the Harvard researcher. Therefore, the Trasylol was still on market until November 2007, it was estimated that during the two years (Jan 2006-Nov 2007) one thousand lives were lost a month.
I think ethical issues are involved in the case. Bayer was expecting a billion dollars from this drug. They marketed the drug aggressively worldwide. As a biology major student, I deeply understand how much effort and money needs to be spent for developing a drug. The approval from FDA for marketing means a lot to the company—money is coming! However good medicine should pay great attention on patients, the company should not focus just on profit. Hiding data in the FDA review session resulted loss of so many patients’ life. Transparency in the drug study is really a must in the future based on Bayer case. On the company side, how to balance the profit margin and ethical concern, how to make decision on these issues is really crucial for the company and for people.
Related link: http://www.cbsnews.com/sections/i_video/main500251.shtml
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