The purpose of this article is to relate recent actions by the United States Department of Justice, the Institute of Medicine, the Association of American Medical Colleges (AAMC), and others to the specific challenges confronting the specialty of orthopaedic surgery. Further, it strives to reconcile the duty and value propositions associated with the orthopaedic surgeon-medical device company relationship, with the persistent risks that are attendant to that relationship, and to develop a new path—one that strives to restore the integrity of scientific investigation and day-to-day clinical decision making, while providing justification for future physician-industry interaction. To consider the topic in perspective, it is interesting to assess the origins of the current model of physician-industry interaction as they relate specifically to the issues currently confronting the specialty of orthopaedic surgery.
In 1980, novel legislation in the field of intellectual property, the Bayh-Dole Act, for the first time allowed universities and nonprofit organizations to replace the government as the principal beneficiaries of commercial development resulting from basic-science and clinical research. In essence, the act transferred the ownership of discoveries made with the help of federal research grants to the universities and small businesses where those discoveries were made. On the face of it, the Bayh-Dole Act made sense. Convinced that government ownership had deterred the development of incentives necessary to promote innovation and had severely inhibited productivity, supporters saw the act as a remedy for the depressed American economy in the 1970s. The goal of the act was specific—to address the concern that American firms were not using academic research efficiently for commercialization—and it intended to remedy that shortcoming by facilitating patenting and licensing by U.S. universities of inventions from federally funded research. If successful, it could help to usher in a new era of innovation in America. It was an interesting …
Enter your JBJS login information below.
Please note that your username is the email address you provided when you registered.