Trasylol Attorney Say Bayer Knew Of Dangers for Years
Neil Overholtz, a Florida attorney whose practice represents clients injured by drugs such as Trasylol, explained what Bayer knew about the dangers of Trasylol and when it knew it in a recent interview.
When did Bayer really know about the potential dangers with Trasylol?
Bayer knew about issues related to renal (kidney) toxicity early on in the development of the drug in the 1980s, according to Overholtz, who says that it should not have been a shock to really anyone, especially Bayer, that this drug was going to affect renal function. He explained:
Their animal studies showed a very strong impact on renal function in certain animals - obviously at doses way beyond that seen in humans. This is my speculation as there isnt any evidence out there. However, what we know about pharmaceutical companies and the way they get drugs approved is through clinical trials. Initially, the first human trials of a drug are given to maybe one or two patients in the first study. Theyre given at doses that, based on the pharmacological calculations, are unlikely to cause any side effects.
The next time they do the test, they do another study on a few people less than ten usually. They do it at a level that is unlikely to show side effects and theyre looking for effectiveness. As soon as they get to an effective dose that shows some efficacy, enough that they can get the drug approved without seeing side effects in that very small group, thats the dose theyre going to seek to get approved. All doctors want is an effective drug and one that doesnt cause side effects.
So, assuming that Bayer knew that this drug was going to cause renal failure in some patients, or that it certainly had the propensity to do it, they were going to try to find a dose that was low enough, at least in the initial clinical trials, that was unlikely to show those types of effects but would show enough effectiveness to get approved. Now, the problem with that approach is when these drugs get used in large populations post approval; thats when these types of side effects begin to show themselves.
Injuries start to be reported
According to Overholtz, by early 2000, case reports were beginning to get published of renal failure and dialysis associated with Trasylol used during surgery. However, case reports dont always speak to causation and so thats where the epidemiology started. He continued:
Now, the problem with epidemiology from a standpoint of a drug like this is that a lot of times its hard to do whats considered the gold standard in epidemiology, which is a double blind, randomized controlled trial looking at whether or not a drug is going to cause a certain side effect or not. You know, there are a lot of heart surgeries in this country and renal failure doesnt occur in most of them - even when they use Trasylol.
It would require a clinical trial with big numbers to see data that would support a cause and relationship between Trasylol and kidney failure or other side effects such as heart attacks or strokes post-surgery. So what do you do? Well, instead you look at the data that you already have. A lot of times that involves looking at patient based populations, case control studies they call them, which is what the Mangano study was. It looked back at patient data involving patients who had suffered kidney failure post open heart surgery. Once you identify the cases, you identify matching controls. Then, between those cases and controls, you look for what drugs they were given during the surgery.
Mangano study provided concrete findings of Trasylol dangers
Dr. Dennis Mangano published a study about the dangers of Trasylol in January 2006 and, according to Overholtz, thats when Bayer should have pulled Trasylol from the market. He told us:
The Mangano study showed a significant increase in those patients who had suffered renal failure during open-heart surgery had been given Trasylol as compared to other post-surgical anti-bleeding drugs. That study was published in January of 2006 and most people now believe that study confirmed findings that Bayer was already seeing in their own study that was being done.
At that point in time, they should have removed this drug from the market. The FDA requested a meeting about this issue in 2006. Bayer had their own study information confirming the results of the Mangano study, but failed to disclose that to the FDA.
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