Trasylol Killed 22,000 People and the FDA could have Prevented It

In January 2006, private researcher Dr. Dennis Mangano came forward and published a study saying Bayer AG’s drug Trasylol had dangerous side effects.

The FDA advisory panel looked into Dr. Mangano’s claims in September 2006. Bayer had researched this claim but did not disclose their findings to the FDA panel at the meeting. The findings confirmed Dr. Mangano’s research, which would have lost Bayer money.

FDA advisory panel chairman Dr. William Hiatt told CBS’s 60 Minutes that he would have voted to remove the drug from the market had Bayer disclosed its findings.

It is figured that approximately 22,000 lives could have been saved had the drug been removed from the market. The drug was finally taken off the market in November of 2007. The drug, which is used to decrease bleeding during open heart surgery but caused kidney failure which lead to the need for dialysis and an increased change of death for the patients.

This brings up several serious issues that both the FDA and more importantly American citizens should be worrying about.

Bayer is, of course, a business and therefore is concerned about profit. But as a drug company, shouldn’t they also have a responsibility to protect their customers? The drugs that they create are to help, not hurt people. Yet their drug killed over 22,000 people.

It is one thing if a company does not realize what the side effects are, but they HAD the research and refused to disclose it. This shows an intentional disregard for its customers or how many lives they kill to make their profits.

Another thing that should be a concern is the FDA’s method of handling this. Yes, they did eventually recall the drug. But at the same time when this information first came out and they checked it out, they didn’t have someone else do the research or confirm that Bayer did not check this information.

Normally I do NOT agree with law suits, but in this case I do feel that the families are justified in suing Bayer. Bayer knowingly withheld information that led to the death of thousands of people. Those people’s blood is on Bayer’s hands.

Overall I question how safe many of the drugs on the market really are and if the FDA is an effective way to prove these drugs are safe. The fact that this information was known and what should have been a life saving procedure killed these people because the medicine doctors used was deemed safe by the FDA should make everyone question the drug companies motives for making medicine—profit or the well being of their customers.