Chapter 3.C.4 (2.B.4) Fiduciary Obligations, Conflicts of Interest, and Novel Disclosure Obligations

Notes: Fiduciary Principles and the Disclosure of Provider-Associated Risk

New note 6.5 Financial Conflicts in Medical Research.

The issue of conflicts of interest in medical research identified in Moore has continued to attract scrutiny. The Institute of Medicine issued a major report in 2009. See, e.g., Bernard Lo and Marilyn J. Field, Editors; Committee on Conflict of Interest in Medical Research, Education, and Practice; Institute of Medicine, Conflict of Interest in Medical Research, Education, and Practice (2009), available online at http://www.nap.edu/catalog.php?record_id=12598#toc. For commentary on the report see Robert Steinbrook, Controlling Conflict of Interest – Proposals from the Institute of Medicine, 360: 21 New Eng. J. Med. 2160-2163 (2009).

In response to the growing concern about the lack of regulatory oversight in this area, some university faculties, medical centers, and research institutions have developed online disclosure programs designed to shed light on the relationships between industry and physicians/researchers. See Robert Steinbrook, Online Disclosure of Physician-Industry Relationships, 360:4 New Eng. J. Med. 325-327 (2009); and, e.g., the online conflict-of-interest reporting programs found at the Cleveland Clinic (www.clevelandclinic.org) and the Duke Clinical Research Institute (www.dcri.org/research/coi.jsp).

Note 7. Other Financial Conflicts.

In her article Informed Consent: Requiring Doctors to Disclose Off-Label Prescriptions and Conflicts of Interest,58 Hastings L.J. 967 (2007), Margaret Z. Johns proposes that the tort doctrine of informed consent be “expanded to require the disclosure of drug company influences that create conflicts of interest or the appearance of conflicts of interest.” Johns argues that off-label uses and drug-company influences are material to a patient’s informed consent:

Since off-label uses have not been proven safe and effective under FDA standards and since most are not supported by scientific evidence, they may carry uncertainties and risks that the patient would not accept. And in deciding whether to accept the risks of any drug – especially an off-label drug – the patient would want to know whether drug-company marketing may have influenced the doctor’s prescribing decision.