"Good medicine demands that you protect the patient. That's the issue here, and not the drug, and not the profit margin," stated Dr. Dennis Mangano, the San Fransico doctor who conducted the largest study to date concerning the dangers of the anti-bleeding drug Trasylol. Dr. Mangano offered these comments during a scathing report featured on 60 Minutes which revealed that Trasylol's manufacturer, Bayer, hid studies from the FDA which showed a clear link between the drug and heart and kidney failure. Other doctors interviewed by CBS suggest that Bayer was aware of dangerous side effects from Trasylol as early as the 1980's.
Trasylol is an anti-bleeding drug that is given to approximately 1/3 of patients undergoing heart surgery. Trasylol was heavily marketed by Bayer and was projected to be the next billion-dollar drug in 2008. Fortunately, Dr. Mangano's efforts set into motion a chain of events that would eventually put a stop to Bayer's ability to profit (and profit a lot) from other's misfortunes.
After following 5,065 patients in 17 countries, Dr. Mangano found that patients given Trasylol were more likely to experience death and kidney failure after heart surgery.
This study was then published in the New England Journal of Medicine, which prompted other doctors to speak out regarding the deadly drug. According to Dr. Juergen Fischer, director of the Institute of Experimental Medicine at the University of Cologne, Bayer was not interested in his results from studies conducted in the 1980's that showed severe kidney damage in animals given Trasylol. Dr. Nicholas Kouchoukos also received the cold shoulder from the pharmaceutical company for his human study in 1992 that showed that patients given Trasylol were more likely to experience kidney failure after surgery.
Kouchoukos called this study a "red flag", but explained that safety studies are generally not taken seriously until they involve thousands of participants. Since Bayer did not conduct a large-scale investigation of the drug following these complaints, the proof was not available to pull the drug from the market. Consequently the FDA approved Trasylol in 1993--noting kidney problems as a potential side effect from the drug.
Thankfully, Dr. Mangano's 5,065 patient study in 2005 was sufficient to finally catch the FDA's attention. The FDA scheduled a meeting with Bayer executives to discuss the issue eight months after the report was issued. As a result, Bayer went on the defense and set out to conduct a study of it's own to dispute Dr. Mangano's study. Their plan backfired. Bayer's study confirmed Dr. Mangano's findings that Trasylol may have been responsible for thousands of deaths and serious injuries in the United States.
What Bayer decided to do with this information next, in my opinion, proves the company's clear disregard for patient safety. Bayer hid their study from the FDA. They acted as though it never took place. It wasn't until a whistleblower from Bayer contacted the FDA regarding the proven dangers of Trasylol that the true findings from the report were made public. Following this disclosure, Canadian researchers attempted to perform their own Trasylol study, but had to stop because too many people were dying.
So what are the consequences of Bayer's lack of scientific testing and honesty regarding Trasylol? According to Dr. Mangano, "Between my study and November 5, when it was taken off the market, there were approximately 431,000 patients who received the drug. As I calculated, 22,000 lives could have been saved. It's about a 1,000 lives saved per month delay in taking that drug off the market."
Sad. And while the story reads like a bad novel, real people's lives have been ruined by this drug. Loved ones have died or were forced to go on dialysis after otherwise routine procedures. Livelihoods were stolen as injured patients struggle just to pay the bills with their meager disability check. Ironically, Bayer walks away with millions of dollars and no consequences from the FDA. And I can almost guarantee that the politicians in Washington will turn a blind eye as well. After all, they need a paycheck too and who do you think funds the campaign that allows them to stay in office? The pharmaceutical companies of course. What politician in his right mind would bite the hand that feeds him?
Clearly, the only remedy for patients that have experienced side effects from Trasylol is to file a lawsuit against Bayer. It's more than just money-it's the only way to change the system. Complaints to the FDA do not work. Letters to Washington do not work. Pharmaceutical sales are big business driven by the desire for profit at any cost. To change the system, the American people have to take what matters the most from these companies-their profit. When they finally realize that they will have to pay for hurting people, maybe they will invest some of their billions into better scientific testing and personnel to handle investigations before drugs like Trasylol, Vioxx and now Heparin take the lives of trusting people who depend on this medicine to make them better, not worse.
About John R. Mininno, Esquire
Attorney John R. Mininno is a licensed New Jersey and Pennsylvania attorney who represents clients in medical malpractice and other serious injury claims. His offices are in Collingswood, NJ and Philadelphia, PA. He also writes on patient safety issues and encourages patients to be their own "patient advocate." If you or a loved one has experienced heart or kidney failure from Trasylol, click here for further information on how to file a trasylol lawsuit
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