by Robert A. Schwartz, Attorney at Law
Nov. 6, 2007
A Nov. 5 Associated Press story reported that under government pressure, Bayer said it would immediately halt worldwide sales of anti-bleeding drug Trasylol. The Food and Drug Administration asked the manufacturer to stop selling the drug, approved in 1993 to prevent excessive bleeding during heart bypass surgery, pending a detailed review of preliminary results from a Canadian clinical study that found Trasylol could be linked to a higher risk of death than other drugs. In a rare move, John Jenkins, director of the FDA’s Office of New Drugs, said during a briefing Monday that the FDA “cannot identify a specific patient population where we believe the benefits of using Trasylol outweighs the risk.”
What prompted the FDA to act was its re-evaluation of the drug’s safety after the January 2006 publication of two studies that linked the drug’s use to serious side effects, including kidney problems, heart attacks and strokes. The 1993 approval was overshadowed by Bayer’s withholding one of those studies from the FDA. A Bayer company investigation later characterized the withholding of the study results as a “regrettable human error.” Not surprisingly, Bayer’s news page on its website did not disclose that.
Why would Bayer withhold this kind of information from the FDA? After all, its mission statement includes “integrity, openness and honesty” among its values. Bayer’s corporate policy also states, in pertinent part:
We believe our technical and commercial expertise entails a duty to contribute to sustainable development — a principle we wholeheartedly endorse, mindful of its social, ethical and environmental elements. In awareness of our responsibilities as a corporate citizen, we define economy, ecology and social commitment as objectives of equal rank.
The answer is simple: profits. By withholding damaging information about one of its profit centers, Bayer protected its profits at the expense of human life. Plainly stated, Bayer put profits over people.
Bayer said that withholding information from and misrepresenting information to the FDA were regrettable errors. When viewed objectively from the standpoint of the executives, these decisions involved an extreme degree of risk considering the probability and magnitude of the harm to those treated with Trasylol. To call it simply “regrettable human error” is meant to soften any repercussion from the executives’ awareness of the risk involved as well as their proceeding forward with those decisions with conscious indifference to the rights, safety and welfare of both consumers and physicians.
When corporations violate federal laws for no other discernable reason than to protect their bottom line, it is neither acceptable nor human error. Further, good corporate citizens do not mask misdeeds and malfeasance by minimizing them as human errors. As a trusted corporation whose over-the-counter pain reliever is in many American households, Bayer cannot be allowed to use such an otherwise acceptable adjective as “regrettable” in such a patently offensive manner. Withholding negative results of a scientific study is more than mere oversight. It is not regrettable that Bayer should have to take responsibility for its actions.