Ischemia Research and Ed. Found. v. Pfizer, Inc. CA6

I. Factual Background

IREF is a nonprofit corporation that collects and analyzes data from clinical trials, which it stores in databases. Dr. Dennis Mangano is a physician, the founder of IREF, and its “principal scientist.” Beginning in 2001, he also served as IREF‟s chief executive officer (CEO). Mangano is very experienced in conducting clinical trials. There are three types of clinical trials. A pharmaceutical company may sponsor a trial; the National Institutes of Health (NIH) may sponsor a trial; or an independent entity, such as IREF, may initiate a trial. Mangano formed a group of physician investigators, called McSPI, who represented the leading cardiac surgery centers. McSPI is an acronym for multi- center study of perioperative ischemia. Perioperative means before, during, or after surgery. Ischemia refers to an organ‟s lack of oxygen. Mangano‟s plan was to have these investigators contribute data to a database. The McSPI investigators joined together and did an observational study of 2,417 1 cardiac artery bypass graft (CABG) surgery patients. An observational study simply observes the history of patients as they go through surgery and during their hospitalization…