Black Edge: Inside Information, Dirty Money, and the Quest to Bring Down the Most Wanted Man on Wall Street

by Sheelah Kolhatkar

The process of developing a new drug was long and expensive; pharmaceutical companies increasingly avoided it in favor of marketing or repurposing drugs that were already in circulation. When they did choose to embark on such a costly journey, it culminated with the human testing phase, the final stretch before a new drug could receive FDA approval and be sold to consumers. Testing began with Phase I, which was the first time a drug was tried out on a small sample of humans. If the drug proved safe and effective on that smaller first group of volunteers, it moved on to Phase II, where it was tested on a larger group of two hundred or so patients. If the drug was shown at that point to be safe and effective, it entered Phase III. There, two independent studies would be done to confirm what had been observed before: that it was safe and that it worked. In 2004, Gilman was recruited by Elan to serve as the chair of the bapi safety monitoring committee, a group of independent clinicians responsible for tracking the progress of the study, to ensure that none of the patients suffered any serious adverse effects.