1 Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02120, USA.
2 Center for Bioethics, Harvard Medical School, Boston, MA 02115, USA.
3 Petrie-Flom Center, Harvard Law School, Cambridge, MA 02138, USA.
4 Warren Alpert Medical School, Brown University, Providence, RI 02903, USA.
5 Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02120, USA. akesselheim@bwh.harvard.edu.