Trasylol: Did Bayer Falsely Convince Many of the Drug’s Effectiveness?

More and more information about Trasylol has become available since Bayer took it off the market in November 2007 and Dr. Dennis Mangano appeared on the popular news show, 60 Minutes, linking the company to potentially thousands of deaths. Legal experts are saying that Bayer may have convinced many that Trasylol was better than it actually was through a grand marketing effort.

Did Trasylol do more than other drugs?

Trasylol, approved for post surgical bleeding primarily after heart surgeries, was supposed to do more than similar drugs that cost far less. However, according to Neil Overholtz, a Florida attorney whose practice represents clients injured by drugs such as Trasylol, all of the available data seems to say that it did not. He explained:

Regarding proof that Trasylol does more, there are really two different things to look at. One is that there was no data that made Trasylol seem to be better than other drugs in heart bypass surgery. In other words, it was able to show effectiveness that met FDA standards. We would argue that it actually is not a very effective drug at all. But the reduction of transfusions in heart surgeries is such that the FDA is willing to approve drugs that can show at least some degree of effectiveness.

If we can stop people from bleeding post-surgically and stop the need for transfusion, that’s a good thing. So, they were able to show enough effectiveness, but there was no data that showed that somehow this drug was better at bypass surgery compared to other types of surgeries or better at bypass surgery than other drugs in the class.

Bayer’s marketing machine was hard at work

Overholtz says that Bayer did a very smart business and marketing move by only asking the FDA to approve it for those types of surgeries. He told us, “Instead of going for the whole thing, they said, ‘Just approve us for bypass surgery.’ Once they got that approval, they turned on the marketing machine, which was to the heart surgeons, and told them, ‘We’re the only drug approved specifically for bypass surgery. The other drugs were approved for all types of open heart surgeries.’ It was a way of creating a niche market for Bayer and Trasylol because they were getting into a saturated market anyway.”

Niche equals big money

The price [of Trasylol compared to other drugs] was also a factor, according to Overholtz. He explained, “You hear different numbers thrown around, but typically a dose of Trasylol used during the surgery was going to cost the patient, or their third party provider, somewhere around $1,200 to $1,500, whereas the drugs on the market already were costing maybe a couple hundred dollars at that time. By 2006, they were all generic, widely available and cost less than $100 per dose. So, the difference in price was tremendous. How do you get a doctor to use a drug that costs so much more? That became the real battle for Bayer on the marketing side.”

If you’ve been injured due to a drug such as Trasylol, contact an attorney whose practice focuses in this area of the law to discuss your situation. Consultations are free, without obligation and strictly confidential. To contact a qualified attorney, please click here. We may be able to help.

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