Statistical Methods for Drug Safety (2015)

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My (RDG) first encounter with statistical issues related to drug safety came on the heels of then President George Bush senior taking the drug Halcion and throwing up on the Japanese ambassador. Sidney Wolfe of Public Citizen immediately filed suit against the U.S. FDA and the Upjohn Company for a myriad of adverse effects of the drug. The FDA turned to the Institute of Medicine (IOM) of the National Academy of Sciences to review the matter. I received a call from Dr. Andy Pope of the IOM asking if I would be willing and interested in being a member of the IOM committee that was to opine on this question. I told him that I would think about it and get back to him. I then called Dr. Joe Flaherty, Dean of the School of Medicine, and asked him if the IOM (which I had never really heard of) was some kind of right-wing religious organization. He told me that it was, but that I should do whatever they asked. I agreed to be a member of the committee, and it led to a series of different committees which have been among the most interesting, challenging, and rewarding scientific experiences of my career.

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