In yesterday’s editorial, the NY Times writes that Bayer’s excuse for hiding serious side effect information on a widely-used drug doesn’t hold much weight. “Bayer A.G.’s limp excuse for withholding data suggesting that a heart-surgery drug is dangerous won’t wash. The failure by the German pharmaceutical giant to inform the Food and Drug Administration of the disquieting results of a large observational study cannot be sloughed off as a mere “mistake on the company’s part.”
Bayer says that it withheld the results of a study of its drug, Trasylol, because the results were preliminary and the company had questions about the methodology and populations of patients.
Hiding serious side effect information?..Same story, different drug company. Bayer’s actions should be no surprise to anyone. We cannot trust drug companies to voluntarily release negative results of drug studies to the public. This editorial has it right, “This incident underscores the importance of requiring drug companies to publicly register all safety studies so that they can’t be suppressed later should their results displease the sponsor.”