Marc Rodwin — Clinical Research and Medical Knowledge

The March 27, 2013 Lab seminar was led by Marc Rodwin, Professor of Law at Suffolk University Law School, and Edmond J Safra Center for Ethics Lab Fellow. Professor Rodwin is the author of Conflicts of Interest and the Future of Medicine: The United States, France and Japan (Oxford, 2011); and Medicine, Money and Morals: Physicians' Conflicts of Interest (Oxford, 1993). He has also published articles on diverse facets of health law, policy and ethics including health care consumer voice and representation; accountability in managed care; consumer protection in health care; medical malpractice; and ownership of patient health data. During his fellowship year, he will conduct a project analyzing organizational, financial, and legal arrangements in drug research, marketing, and regulation that weaken the effectiveness of institutions that seek to advance medical knowledge, drug safety and public health. He will examine the pros and cons of reform options, including ending public dependence on pharma for important activities; changing incentives/compensation for drug firms; and making drug firms responsible for how drugs are used.

Professor Rodwin began his presentation by discussing the different ways in which medical knowledge becomes biased or corrupted. He distinguished between two different types of bias: topic bias and content bias. Topic and question choice corruption, he explained, occurs when the clinical issues discussed and research questions raised are changed by manufacturer influence. Professor Rodwin argued that this type of bias is the most unrecognizable of the two and has far-reaching implications to the body of medical knowledge. Content bias, he explained, is the actual biasing of scientific data, methodologies, and analysis. At this point in presentation, one participant of the Lab suggested that topics can be corrupted simply by the way in which they are framed. He argued that corporate funding and sponsoring produces a bending effect in the framing of clinical research questions and agenda setting, especially when newly developed drugs are ushered through clinical trials to receive FDA approval.

With respect to manufacturer influence, Professor Rodwin discussed how pharmaceutical companies deceptively use advertising and promotion as a means to educate physicians, with the aim of selling more drugs. He explained that this industry practice has been commonplace for decades, and cited the testimony of Charles D. May, former editor of the AMA Journal of Pediatrics, who once testified at the Kefauver hearings during the late 1950s, that advertising is "the masquerading of promotion as education" and "pharmaceutical promotion cannot be accepted as a trustworthy means of bringing accurate information to physicians."

In summary, Professor Rodwin discussed how the production of medical knowledge differs from the production of knowledge in other areas of science and social science. He explained the various ways that pharma exerts influence on research and damages the integrity of medical knowledge. Further, participants engaged in lively discussions centered on sources of risk for institutional corruption in medical research and drug development.