Bayer finally gave into the overwhelming negative evidence regarding its drug Trasylol and is pulling it off the shelves. Yesterday, a study was released by the New England Journal of Medicine ("NEJM") in which a study Bayer was hoping would save this drug, instead indicated "...the strong and consistent negative mortality trend associated with aprotinin (trasylol) as compared with lysine analogues precludes its use in patients undergoing high-risk surgery." As reported by both Bloomberg and Reuters, as a result of the release of this study, referred to as the BART study, Bayer has decided to remove the remaining supplies of the drug Trasylol from the U.S. market. Moreover, the FDA has indicated that Bayer has confirmed to it that it will be removing the stock of Trasylol from the U.S. market, which is presently being kept in warehouses, hospitals and doctor's offices.
As I have previously discussed, Trasylol is a drug manufactured by Bayer and has been used in open heart surgery since 1993 to reduce the bleeding that can be caused in this type of surgery. From the day it was approved by the FDA, there have been questions raised about its potential to cause renal/kidney failure. When originally approved by the FDA, it was only approved for high risk open heart surgeries which are typically defined as an individual undergoing a second or more open heart surgery, heart valve surgery, or an individual with a high risk of bleeding. Eventually, the drug was approved for use in ALL open heart surgeries and that's when things started to go wrong. In 2006, a Dr. Mangano published a study in the NEJM which called into question the increased risks of kidney failure and death, among other things, caused by use of this drug. Bayer, as most big pharmaceutical companies will do when one of its drugs gets called into question, went on the attack to discredit not only Mangano's study, but Mangano himself.
It was a two year bitter battle. It included Bayer withholding its own study on the drug during a FDA hearing about the drug, which study only came to light after its author disclosed its existence after the hearing when he couldn't understand why Bayer did not tell the FDA about the study at the hearing itself. At the end of 2007, another FDA hearing was held on the drug which I attended by webinar. Dr. Mangano himself spoke to the FDA panel defending the work he had done. Bayer did all it could do to discredit Mangano's work and hired statisticians to completely confuse the issue. During that hearing, Bayer talked about a study being done in Canada, called the BART study, which was using Trasylol and comparing it to two generic drugs which do the same thing and cost a lot less, in high risk open heart surgeries, the types of surgeries which Trasylol was originally approved for. Bayer indicated to the panel that they hoped this clinical study would provide a lot of answers and show what a great drug Trasylol was.
Within about 2 months of that meeting, the walls caved in. An unexpected announcement came that the BART study was being closed down because too many people were dying that were being given Trasylol. As a result, the FDA and Bayer put a "temporary halt" on use of the drug, except in extreme situations, pending evaluation of the information which could be obtained from this BART study.
Well, now its out in black and white. Essentially, the study found that Trasylol did not do that much better a job than its generic competitors and Trasylol cost $1400 per surgery versus $4 per surgery for the generics. Yes, you read that right $4 (four dollars). More importantly, those patients being given the Trasylol were dying at a higher rate within 30 days of the surgery then those given the generics. Thus, even using the drug for the limited purpose for which it was originally approved i.e. high risk surgeries, more people died who were given the drug within 30 days than who were given the much cheaper alternative which performed comparably. As the editorial in the NEJM said it"...in all likelihood, this is the end of the aprotinin (trasylol) story." It appears today it is and way overdue.
What has always been so insidious about the use of this drug is that patients never know they were given the drug as it is given during the anesthesia process for surgery. Thus, when things later go wrong, whether it be kidney failure or death, the patient and the family would never know it may have been the drug Trasylol which caused the problem. Now at least, the drug will be kept out of the surgery room and away from the unsuspecting patient.
If you feel you or a family member may have been given this drug during open heart surgery and have ended up in kidney failure or died unexpectedly, you are welcome to contact me to discuss whether you may have a potential case regarding Trasylol.
