In addition to a study of 13, 000 patients that will be used to convince the FDA to approve the drug, Novartis is conducting an 18, 000-patient outcomestudy to try and demonstrate that its drug does not cause an increased risk, however rare, of heart attack.
Lieberman is adamant that Vibram sponsorship had nothing to do with the outcome of the study, which was also funded by the American School of Prehistoric Research, the Goelet Fund and Harvard University.