Last fall an FDA panel unanimously voted in favor of keeping Bayer’s Trasylol on the market. The panel was convened after a New England Journal of Medicine article suggested that the drug put patients at a higher risk for heart attack, stroke, and renal failure than its cheaper alternatives. The study commissioned by Dennis Mangano, the founder of the nonprofit Ischemia Research and Education Foundation, speculated that lower-risk alternatives could be substituted for Trasylol in most cases saving $250 million per year in health care costs, and an additional $1 billion per year for the cost of dialysis. The panel punched holes in Mangano’s reasoning and questioned the validity of the research, giving Trasylol the unanimous support of the panel.
Only days later the FDA was contacted by Alexander Walker of Harvard’s School of Public Health. Bayer had hired Walker six months earlier to evaluate some 67,000 bypass patients comparing the effects of Trasylol with that of the two other similar drugs. Walker’s finding matched those produced by Mangano’s study. He found patients treated with Trasylol to be at a higher risk for congestive heart failure, stroke, kidney failure, and death. Walker claimed that Bayer was well aware of this study and had “mistakenly” failed to mention this rather important study.
Mangano believes that his study was discounted by the panel due to influence from Bayer. He claims that several members of the panel are closely tied to the organization, and that this is a common scene throughout the system.
“The whole thing was a set-up. We did not have anything to gain financially by this. We were making an observation about safety,” says Mangano, an anesthesiologist with a doctorate in math. “The system is ridiculous. It’s all pro-industry. Who’s protecting the patient?”
He proposes that any drugmaker that hides data from the FDA should be banned immediately from submitting new drug applications for three years. “The pharmaceutical industry would straighten up in a matter of seconds because you’d be hitting them in the pocketbook. If you don’t give drug companies boundaries, they’ll do anything they want. Only the end user here is the patient, and I think it’s critical for the government to assume the goal of protecting patients.”