A new initiative will help more patients gain access to experimental drugs, devices, and biologics. “Typically, these patients are intensely vulnerable and in some cases, frankly, desperate,” says Andrew G. Shuman, MD, FACS, co-director of the program in clinical ethics and chair of the adult ethics committee and consultation service at University of Michigan Medical School in Ann Arbor.

The FDA’s expanded access program is designed to provide patients with opportunities to obtain investigational drugs or devices outside of a clinical trial. “The ethical issues involve ensuring that patients and families are adequately informed of the unproven benefits of these interventions and that efforts are made to mitigate unrealistic expectations,” says Shuman.

Partner universities will build a national framework for more efficient, consistent, and widespread use of the program and help more hospitals offer experimental options to their patients. The Michigan Institute for Clinical and Health Research will coordinate the new project, called Transforming Expanded Access to Maximize Support and Study. “Given the vital role of industry in availing access, ethical concerns exist regarding conflicts of interest, cost management, and avoidance of coercion,” notes Shuman.

Collaborating centers will work with companies seeking to make their products available through expanded access. “Ethicists are embedded within these teams to proactively address concerns, both on the part of patients and families, as well as clinicians and the research team,” says Shuman.


• Andrew G. Shuman, MD, FACS, Co-Director, Program in Clinical Ethics, Center for Bioethics and Social Sciences in Medicine, University of Michigan Medical School, Ann Arbor. Phone: (734) 232-0120. Email: Email: shumana@med.umich.edu.