Conflicts of interest have been reduced to financial conflicts. The National Institutes of Health’s new rules for managing conflicts of interest in medical research, the first major change to the regulations in over 15 years, address only financial ties. Although several commentators urged that the regulations also cover non-financial interests, the Department of Health and Human Services declined to do so. Similarly, the Institute of Medicine’s influential 2009 Conflict of Interest Report focuses almost exclusively on financial conflicts. Institutional policies at (...) academic medical centers and guidance from professional bodies and medical journals also primarily emphasize financial ties. Even broadly worded rules are applied more readily to financial ties than non-financial interests, such as the regulations that restrict institutional review board members with conflicting interests from participating in protocol reviews. (shrink)

The Patient Protection and Affordable Care Act created the nation's first comprehensive comparative effectiveness research (CER) program. According to some optimistic accounts, CER will revolutionize clinical practice and transform the health care delivery system. But what about public health? There are reasons for concern that it could end up left behind in the new era of comparative effectiveness. This article analyzes the considerable promise and serious limitations of applying CER to public health. It also highlights important issues that will likely (...) emerge for public health law and policy as the health care system transitions to greater reliance on CER. (shrink)

As a result of health care reform, medicine has entered a new era of comparative effectiveness. The Patient Protection and Affordable Care Act created the nation’s first comprehensive comparative effectiveness research program, investing in CER at record levels and establishing a new regulatory framework for oversight of the research. CER attracts considerable enthusiasm as a tool for reform because it compares competing interventions to determine which works best, supplying critical information for medical decision-making and health policy. In theory, better evidence (...) of how treatments fare relative to one another will translate to better medical care. According to some optimistic accounts, CER can lead to a “revolution” in clinical practice, has transformative power “to reshape major portions of the practice of medicine,” and represents a major “turning point” for the health care system. (shrink)