As the quest for advancement in medical science races forward at breakneck speed, what price do we, the patient/consumer, pay for those services? We pay far more than just the high cost of medical premiums and expenses of doctoring and drugs. We pay with our lives.
Trasylol aka aprotinin, an anti-bleeding drug, has recently gone through a very rigorous Canadian study which found that patients receiving the medication during heart surgery were much more likely to die than patients that were given one of two other drugs used to prevent massive blood loss during heart surgery.
Approved in 1993, questions concerning the safety of Trasylol weren’t raised until 2006 when a large study appeared to link its use to an increased risk of death by kidney failure, heart attack, and stroke.
The Canadian government paid for the study which included more than 2,300 patients that had multiple health problems or high risk of bleeding. Chosen randomly, these patients received one of two other anti-bleeding drugs or Trasylol during heart surgery.
The analyzed study data showed an increased chance of death by Trasylol at 54 percent compared to the other two drugs – which are also much cheaper. Even though patients needing a transfusion or suffering from massive bleeding fared slightly better with Trasylol, six percent of the Trasylol patients died within 30 days of surgery whereas patients who got one of the other two drugs (Amicar or Cyklokapron) carried a four percent death rate.
Trasylol is made by Bayer AG, and it was linked to prior studies that showed an elevated risk of death after surgery. Bayer temporarily pulled the drug out of the market in November, two weeks after the preliminary study results showed the Trasylol group had a higher death rate. The study was stopped when results showed a higher death rate in the group that took Trasylol.
"There was no way we could ethically enroll (more patients) in the trial because we had our answer," said lead researcher Dean A. Ferguson, a transfusion medicine expert at the Ottawa Health Research Institute. "I think the results are quite definitive, certainly for high-risk cardiac surgery, and it's going to be very tough to justify its use in lower-risk surgery."
Bayer is still deciding what to do and claims to be waiting for details of the recent Canadian study.
Lawsuits numbering in the dozens have been filed against Bayer and claim the company hid evidence of harm and that excess death was caused by Trasylol. The drug is still available under special programs in the United States and other countries although the FDA states that Bayer has begun removing any remaining stock of the drug from the United States market.


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