Abstract

Now more than ever, doctors are being targeted by government prosecutors and whistleblowers challenging the legality of their relationships with drug and device companies. With reputations at stake and the risk of civil and criminal liability, it is incumbent upon doctors to protect themselves.

Managing Relationships with Industry: A Physician’s Compliance Manual is an indispensable resource for doctors, professional societies, academic medical centers, community hospitals, and group practices struggling to understand the ever changing law and ethical standards on interactions with pharmaceutical and device companies. It is the first comprehensive summary of the law and ethics on physician relationships with industry written for the physician. Authored by a former state Attorney General, Harvard Medical School Professor, health care lawyer and professor of ethics, Managing Relationships approaches the topic from a balanced and reasoned perspective adding to the on-going national dialogue and debate on the proper limits to medicine’s relationship with industry.

• The first complete and up-to-date summary and analysis of the law and ethics on physician-industry relationships
• Focuses on major enforcement actions and whistleblower lawsuits and the lessons learned for physicians
• Provides options and guidance for maintaining compliant relationships and avoiding traps for the unwary
• Covers both drug and device company relationships
• Summarizes the types of industry relationships that are necessary and productive and those that are harmful and abusive
• Details the law and ethics for each type of relationship including gifts, off-label uses and marketing, CME, speaker’s bureaus, free samples, grants, consulting arrangements, etc.
• Includes sample contracts for permissible consulting and CME speaker engagements

“A timely balanced and thoughtful book combining
important reference material, practical real world issues and broadly informed perspective that allow healthy dialogue among physicians, government, the public and the device and drug industries. An important step toward clearing the air and setting a course for de-risking physician-industry interactions and aligning incentives for improving patient care. Physicians and the public are exposed to polarized, incomplete and biased debates about how physicians and their organizations should manage their relationships with industry. This book gives one the wisdom and confidence to find the best balance between avoidance of conflicts and achieving the highest benefits for patients.”
-John A. Parrish, M.D., Executive Director and Founder of CIMIT, the Center for Integration of Medicine and Innovative Technology
“This book is an important contribution to the ongoing discussion inside and outside the medical profession on the legal and ethical boundaries for doctors in their relationships with pharmaceutical and device makers.”
-Donald M. Berwick, MD, MPP, President and CEO, Institute for Healthcare Improvement
“In these times, virtually all physicians have interactions with the industry, and this book addresses the relevant issues. Every practicing physician who makes contact with the health care industry will find this volume an invaluable reference – and a wonderful guide to both ethical and legal behavior.”
-Roger J. Porter, MD, Former Deputy Director of NINDS(NIH);Co-Author of Biomedical Research Collaboration and Conflict of Interest
“This book provides physicians, lawyers, and the public with an invaluable review of the ethical and legal issues raised by physician-industry relationships, and a practical guide to ethically-sound guidelines and policies”
-Lachlan Forrow, MD., Associate Professor of Medicine, Harvard Medical School, President, The Albert Schweitzer Fellowship
“The track record for the relief of human suffering by the pharmaceutical and device industry has been spectacular. For this progress to continue, all parties must work together, conscious of, adhering to, and always answerable to the question of conflict of self-interest. This book details solid legal and ethical guidance, which if followed, will move us in the right direction and create welcomed positive synergy between the pharmaceutical - medical device industry and physicians.”
-Leonard Morse, MD, Commissioner of Public Health, City of Worcester, Massachusetts; Professor of Clinical Medicine, Family Medicine and Community Health, University of Massachusetts Medical School; Past Chair of the AMA's Council on Ethical and Judicial Affairs.