Ethics: The Role of Industry and Academia


David Bailey, MD
Dean and Vice Chancellor for Health Affairs, School of Medicine
University of California, Irvine, School of Medicine

Charles Rosen, MD
Clinical Professor, Department of Orthopaedic Surgery, University of California, Irvine
President and Founder, Association for Ethics in Spine Surgery

Ranjan Gupta, MD
Professor and Chairman, Department of Orthopaedic Surgery, University of California, Irvine

Welcoming and introductory remarks were made by Dr. David Bailey, Dr. Ranjan Gupta, Dr. Charles D. Rosen.

Ethics I

Felicia Cohn, PhD
Director of Medical Ethics and Associate Adjunct Professor, University of California, Irvine

Dr. Felicia G. Cohn, discussed the complex issues in conflicts of interest and introduced methods of ethical analysis and tools for decision making. She framed key ethical questions, goals for ethical medical practice and research, and criteria for justifying potential guidelines.

To view Dr. Cohn’s presentation, click here

Session I – Medical Devices

Moderator and Speaker: Charles D. Rosen, MD

Stuart Green, MD
Clinical Professor, Department of Orthopaedic Surgery, University of California, Irvine

This discussion was moderated by Dr. Charles Rosen and included co-panelist Dr. Stuart Green. Dr. Rosen discussed conflicts of interest in medical devices and the Association for Ethics in Spine Surgery. Dr. Green spoke on conflicts of interest throughout the history of medicine.

To view Dr. Green’s presentation, click here
To view Dr. Rosen’s presentation, click here

Session II – Clinical Trials

Moderator: Bang Hoang, MD
Orthopaedic Oncologist, Assistant Professor, Department of Orthopaedic Surgery and a Member, Chao Family NCI-Designated Comprehensive Cancer Center, University of California, Irvine.

Leonard Sender, MD
Director, Clinical Oncology Services, Department of Medicine, University of California, Irvine

John Fruehauf, MD
Health Sciences, Associate Clinical Professor of Medicine, University of California, Irvine
Director, Clinical Pharmacology and Developmental Therapeutics

Zeev Kain, MD
Associate Dean for Clinical Research, Professor and Chairman, Dept of Anesthesiology, University of California, Irvine

Dr. Leonard Sender addressed the unique aspects of the ethics involved in treating children and adolescents on clinical trials, the lack of pharmaceutical company trials for this population and how this presents unique ethical challenges. Dr. John Fruehauf spoke to the importance of transparency in investigator/pharma relationships for investigators participating in pharma sponsored and investigator initiated trials. Dr. Zeev Kain discussed conflicts of interest from his perspective as Associate Dean for Clinical Research.

To view Dr. Sender’s presentation, click here
To view Dr. Fruehauf’s presentation, click here
To view Dr. Kain’s presentation, click here

Session III – Industry and Government

Moderator: Charles D. Rosen, MD

Peter Winn
Assistant United States Attorney, Department of Justice

Chad Phipps
General Counsel, Zimmer Corp

Jack Mitchell
Chief Investigator, Senate Special Committee on Aging

Moderator Dr. Charles Rosen led the panel on industry and government. Assistant United States Attorney Peter Winn addressed the legal aspect of issues surrounding the influence of industry on medical care. He focused on, among other things, violations of the federal anti-kickback laws as well as the Stark Statute. Chad Phipps, General Counsel, Zimmer, Inc., discussed Zimmer’s newly enhanced business model for collaborating with health care professionals in the areas of product development, surgeon training, educational and charitable funding, and transparency. Jack Mitchell, Chief Investigator, Senate Special Committee on Aging, spoke on the role of Congressional oversight on the issues of disclosure and ethics.

To view Mr. Phipps’ presentation, click here

Ethics II

Michael Kalichman, PhD
Professor, University of California, San Diego

Dr. Kalichman summarized some of the key practical and ethical issues raised during the morning discussion. He concluded with a framework for some concrete steps and questions that will help address the real and perceived problems of financial conflicts in medical research and medicine.

Panel Discussion and Question and Answer Sessions with Panelists

Closing Remarks and Adjournment: Charles D. Rosen, MD

Videos Section

Ethics I Intro

Cohn Presentation

Green Presentation

Rosen Presentation

Intro Session 2

Sender Presentation

Fruehauf Presentation

Kain Presentation

Phipps Presentation

Winn Presentation

Mitchell Presentation

Kalichman Presentation

Panel Discussion