Competing interests: We have read and understood BMJ policy on declaration of interests and declare that both authors have received research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing; from Medtronic and the Food FDA to develop methods for postmarket surveillance of medical devices (U01FD004585), and from the Centers for Medicare and Medicaid Services (CMS) to develop and maintain performance measures that are used for public reporting (HHSM-500-2013-13018I). JSR has received research support through Yale University from the FDA to establish Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938), from the Blue Cross Blue Shield Association to better understand medical technology evaluation, from the Agency for Healthcare Research and Quality (R01HS022882), from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R01HS025164), and from the Laura and John Arnold Foundation to establish the Good Pharma Scorecard at Bioethics International and to establish the Collaboration for Research Integrity and Transparency (CRIT) at Yale; HMK chairs a scientific advisory board for UnitedHealthcare. During 2004-06, both authors were consultants at the request of plaintiffs for suits against Merck related to rofecoxib.