Trasylol: 10,000 Floridians at Risk

Fort Meyers, FLIt was revealed this week that as many as 10,000 Floridians have either lost their lives, or whose health have been seriously compromised at the hands of Trasylol, the vilified anti-bleeding drug pulled from the market in November of last year.

A spate of recent media reports culminated in the February 17th airing of 60 Minutes on CBS, which profiled the heartbreaking story of Trasylol patient Joe Randone and featured renowned researcher Dr. Dennis Mangano. The latter estimates that 22,000 lives could have been saved—or about 1000 a month—had the makers of Trasylol, Bayer AG, pulled the product off the market two years ago when several red flags were flapping in the wind, including Mangano's own study.

Instead, Bayer is alleged to have suppressed evidence and soft-pedaled the issue in an effort to keep Trasylol on the market. It was only when faced with insurmountable evidence suggesting Trasylol was potentially harmful, that Bayer finally acted and pulled Trasylol altogether.

The impact of Trasylol is such that a law firm based in Fort Meyers is setting up a dedicated claims unit. Marcus Viles, a partner with law firm Viles & Beckman LLC, told the South Mississippi Sun-Herald, "How many thousands of patients needed to die from strokes or heart attacks, or suffer kidney failure before Bayer finally decided to recall Trasylol?"

Trasylol was a blockbuster performer for Bayer AG, even though the cost was significantly higher than similar drugs that proved just as effective, according to Dr. Mangano's study, in controlling bleeding during open heart surgery without the side effects.

And yet, as pinched as the national health care system is in terms of resources, sales of Trasylol continued to grow to nearly unprecedented levels, thanks in part to aggressive marketing by Bayer.

At its peak, Trasylol was being used in two-thirds of all open-heart surgical procedures.

Mangano estimates that over the two years between his original call for the removal of Trasylol, and when the drug was finally recalled last November 431,000 patients were administered the drug. Of those, Mangano calculates that 22,000 died. That leaves 409,000 who either were not affected by the drug, or are having to deal with a litany of health problems and adverse effects, not the least of which is renal failure, or failure of the kidney. Heart attack and stroke has also been linked to Trasylol.

What raises Viles' ire is the fact that patients are not routinely told what drugs are used during their surgery, unless the patient is proactive and request their medical records.

Therefore, patients could have been given Trasylol during the course of an open-heart surgical procedure and never know it.

Taking that point one step further, were a patient to suddenly encounter a heart attack or stroke, or suffer from kidney failure and suddenly require dialysis, that patient or their loved ones may never know that it may have been a drug administered during heart surgery that serves as the root cause for death, or dire health consequences.