Remarks by Sheldon Krimsky

Remarks by Sheldon Krimsky

Biomedical Research Presentation

When the industrial biotechnology sector was launched around 1980 it was met with a new congressional and presidential initiative to stimulate U.S. competitiveness. The idea behind the initiative was that forging partnerships between corporations and universities would accelerate technology transfer, enhance translational science, and elevate U.S. global competitiveness in high technology. The unintended consequences of this policy was that it produced an unprecedented growth in university conflicts of interest (COIs).

Unease and response to academic COIs first came from journal editors. The first COI policies were adopted by leading medical journals in the mid-1980s. By the early 1990s Congress held hearings on COI, one titled "Can Conflicts of Interest be Dangerous to Our Health?" In 1995 the Public Health Service (which includes the National Institutes of Health) and the National Science Foundation issued the first set of federal guidelines on conflicts of interest for institutions that receive government grants and contracts. A growing body of social science research corroborated the existence of a "funding effect," where data show that the outcome of research is affected by COIs.

By 2007-8 Senator Charles Grassley's (R-Iowa) investigations revealed that university COI disclosure policies were being blatantly and egregiously violated. In response, the Public Health Service issued a new set of proposed COI guidelines in May 2010. This workshop will explore the role of COIs in shaping research agendas and in producing balanced and honest scientific risk assessments in biotechnology.