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Supplement Editors:
Allen Bashour, MD, and Eric Kodish, MD
Contents
Most of the articles in this supplement were developed from audio transcripts of the summit’s presentations and panel discussions. The transcripts were edited by the Cleveland Clinic Journal of Medicine staff for clarity and conciseness, and were then review and revised/approved by the respective speaker or panelists. Exceptions are the articles followed by an asterisk (*) below, which were submitted as manuscripts by their authors.
From the summit directors*
Eric Kodish, MD, and Allen Bashour, MD
Editors and contributors
Welcome—Ethics in surgical innovation: Vigorous discussion will foster future progress
Delos M. Cosgrove, MD
Panel 1: Surgical Innovation and Ethical Dilemmas
Surgical innovation and ethical dilemmas: Precautions and proximity*
Joseph J. Fins, MD
Surgical innovation and ethical dilemmas: A panel discussion
Isador Lieberman, MD; James Herndon, MD; Joseph Hahn, MD; Joseph J. Fins, MD; and Ali Rezai, MD
Panel 2: Transplant Innovation and Ethical Challenges
Pushing the envelope in transplantation: Three lives at stake*
Pauline W. Chen, MD
Transplant innovation and ethical challenges: What have we learned? A collection of perspectives and panel discussion
Denton A. Cooley, MD; John J. Fung, MD, PhD; James B. Young, MD; Thomas E. Starzl, MD, PhD; Mark Siegler, MD; and Pauline W. Chen, MD
We have come far, but selecting organ recipients remains an ethical minefield—Denton A. Cooley, MD
Despite the odds, the transplant field has progressed rapidly—John J. Fung, MD, PhD
A continued need for evidence-based guidance—James B. Young, MD
What does—and does not—spur innovation?—Thomas E. Starzl, MD, PhD
Panel discussion—Moderated by Mark Siegler, MD
Keynote Address
Medical professionalism in a commercialized health care market*
Arnold S. Relman, MD
Panel 3: Inside the Operating Room
Inside the operating room—balancing the risks and benefi ts of new surgical procedures: A collection of perspectives and panel discussion
Joel D. Cooper, MD; Ralph V. Clayman, MD; Thomas M. Krummel, MD; Philip R. Schauer, MD; Christopher Thompson, MD, MHES; and Jonathan D. Moreno, PhD
How should we introduce and evaluate new procedures?—Joel D. Cooper, MD
Idea to implementation: A personal perspective on the development of laparoscopic nephrectomy—Ralph V. Clayman, MD
Special perspectives in infants and children—Thomas M. Krummel, MD
Bariatric surgery: What role for ethics as established procedures approach new frontiers?—Philip R. Schauer, MD
Natural orifice transluminal endoscopic surgery: Too much too soon?—Christopher Thompson, MD, MHES
Panel discussion—Moderated by Jonathan D. Moreno, PhD
Keynote Address
Will the United States maintain its position as a world leader in medical technology?
Thomas J. Fogarty, MD
Panel 4: Outside the Operating Room
Outside the operating room—economic, regulatory, and legal challenges: A collection of perspectives and panel discussion
Lawrence K. Altman, MD; Michael A. Mussallem; Rebecca Dresser, JD; Paul A. Lombardo, PhD, JD; Peter A. Ubel, MD; and Christopher L. White, Esq
Preface—Lawrence K. Altman, MD (Moderator)
A device company perspective: Serving patients is the key to sustainable success—Michael A. Mussallem
A regulatory and legal perspective: Issues in off-label device use—Rebecca Dresser, JD
A historical perspective: The more things change, the more they remain the same—Paul A. Lombardo, PhD, JD
An economic value perspective: Setting limits on health care can be ethical—Peter A. Ubel, MD
An industry perspective: Proactive self-regulation through an industry code of ethics—Christopher L. White, Esq
Panel discussion—Moderated by Lawrence K. Altman, MD
Panel 5: New Surgical Devices and Ethical Challenges
New surgical devices and ethical challenges: A collection of perspectives and panel discussion
Daniel Schultz, MD; Mary H. McGrath, MD, MPH; Thomas H. Murray, PhD; Roy K. Greenberg, MD; and Thomas J. Fogarty, MD
An FDA perspective on device regulation—Daniel Schultz, MD
Responsibilities of the media, FDA, and professional societies—Mary H. McGrath, MD, MPH
Promoting swift, safe, and smart innovation—Thomas H. Murray, PhD
Panel discussion—Moderated by Roy K. Greenberg, MD
Supplement Editors:
Allen Bashour, MD, and Eric Kodish, MD
Contents
Most of the articles in this supplement were developed from audio transcripts of the summit’s presentations and panel discussions. The transcripts were edited by the Cleveland Clinic Journal of Medicine staff for clarity and conciseness, and were then review and revised/approved by the respective speaker or panelists. Exceptions are the articles followed by an asterisk (*) below, which were submitted as manuscripts by their authors.
From the summit directors*
Eric Kodish, MD, and Allen Bashour, MD
Editors and contributors
Welcome—Ethics in surgical innovation: Vigorous discussion will foster future progress
Delos M. Cosgrove, MD
Panel 1: Surgical Innovation and Ethical Dilemmas
Surgical innovation and ethical dilemmas: Precautions and proximity*
Joseph J. Fins, MD
Surgical innovation and ethical dilemmas: A panel discussion
Isador Lieberman, MD; James Herndon, MD; Joseph Hahn, MD; Joseph J. Fins, MD; and Ali Rezai, MD
Panel 2: Transplant Innovation and Ethical Challenges
Pushing the envelope in transplantation: Three lives at stake*
Pauline W. Chen, MD
Transplant innovation and ethical challenges: What have we learned? A collection of perspectives and panel discussion
Denton A. Cooley, MD; John J. Fung, MD, PhD; James B. Young, MD; Thomas E. Starzl, MD, PhD; Mark Siegler, MD; and Pauline W. Chen, MD
We have come far, but selecting organ recipients remains an ethical minefield—Denton A. Cooley, MD
Despite the odds, the transplant field has progressed rapidly—John J. Fung, MD, PhD
A continued need for evidence-based guidance—James B. Young, MD
What does—and does not—spur innovation?—Thomas E. Starzl, MD, PhD
Panel discussion—Moderated by Mark Siegler, MD
Keynote Address
Medical professionalism in a commercialized health care market*
Arnold S. Relman, MD
Panel 3: Inside the Operating Room
Inside the operating room—balancing the risks and benefi ts of new surgical procedures: A collection of perspectives and panel discussion
Joel D. Cooper, MD; Ralph V. Clayman, MD; Thomas M. Krummel, MD; Philip R. Schauer, MD; Christopher Thompson, MD, MHES; and Jonathan D. Moreno, PhD
How should we introduce and evaluate new procedures?—Joel D. Cooper, MD
Idea to implementation: A personal perspective on the development of laparoscopic nephrectomy—Ralph V. Clayman, MD
Special perspectives in infants and children—Thomas M. Krummel, MD
Bariatric surgery: What role for ethics as established procedures approach new frontiers?—Philip R. Schauer, MD
Natural orifice transluminal endoscopic surgery: Too much too soon?—Christopher Thompson, MD, MHES
Panel discussion—Moderated by Jonathan D. Moreno, PhD
Keynote Address
Will the United States maintain its position as a world leader in medical technology?
Thomas J. Fogarty, MD
Panel 4: Outside the Operating Room
Outside the operating room—economic, regulatory, and legal challenges: A collection of perspectives and panel discussion
Lawrence K. Altman, MD; Michael A. Mussallem; Rebecca Dresser, JD; Paul A. Lombardo, PhD, JD; Peter A. Ubel, MD; and Christopher L. White, Esq
Preface—Lawrence K. Altman, MD (Moderator)
A device company perspective: Serving patients is the key to sustainable success—Michael A. Mussallem
A regulatory and legal perspective: Issues in off-label device use—Rebecca Dresser, JD
A historical perspective: The more things change, the more they remain the same—Paul A. Lombardo, PhD, JD
An economic value perspective: Setting limits on health care can be ethical—Peter A. Ubel, MD
An industry perspective: Proactive self-regulation through an industry code of ethics—Christopher L. White, Esq
Panel discussion—Moderated by Lawrence K. Altman, MD
Panel 5: New Surgical Devices and Ethical Challenges
New surgical devices and ethical challenges: A collection of perspectives and panel discussion
Daniel Schultz, MD; Mary H. McGrath, MD, MPH; Thomas H. Murray, PhD; Roy K. Greenberg, MD; and Thomas J. Fogarty, MD
An FDA perspective on device regulation—Daniel Schultz, MD
Responsibilities of the media, FDA, and professional societies—Mary H. McGrath, MD, MPH
Promoting swift, safe, and smart innovation—Thomas H. Murray, PhD
Panel discussion—Moderated by Roy K. Greenberg, MD
Supplement Editors:
Allen Bashour, MD, and Eric Kodish, MD
Contents
Most of the articles in this supplement were developed from audio transcripts of the summit’s presentations and panel discussions. The transcripts were edited by the Cleveland Clinic Journal of Medicine staff for clarity and conciseness, and were then review and revised/approved by the respective speaker or panelists. Exceptions are the articles followed by an asterisk (*) below, which were submitted as manuscripts by their authors.
From the summit directors*
Eric Kodish, MD, and Allen Bashour, MD
Editors and contributors
Welcome—Ethics in surgical innovation: Vigorous discussion will foster future progress
Delos M. Cosgrove, MD
Panel 1: Surgical Innovation and Ethical Dilemmas
Surgical innovation and ethical dilemmas: Precautions and proximity*
Joseph J. Fins, MD
Surgical innovation and ethical dilemmas: A panel discussion
Isador Lieberman, MD; James Herndon, MD; Joseph Hahn, MD; Joseph J. Fins, MD; and Ali Rezai, MD
Panel 2: Transplant Innovation and Ethical Challenges
Pushing the envelope in transplantation: Three lives at stake*
Pauline W. Chen, MD
Transplant innovation and ethical challenges: What have we learned? A collection of perspectives and panel discussion
Denton A. Cooley, MD; John J. Fung, MD, PhD; James B. Young, MD; Thomas E. Starzl, MD, PhD; Mark Siegler, MD; and Pauline W. Chen, MD
We have come far, but selecting organ recipients remains an ethical minefield—Denton A. Cooley, MD
Despite the odds, the transplant field has progressed rapidly—John J. Fung, MD, PhD
A continued need for evidence-based guidance—James B. Young, MD
What does—and does not—spur innovation?—Thomas E. Starzl, MD, PhD
Panel discussion—Moderated by Mark Siegler, MD
Keynote Address
Medical professionalism in a commercialized health care market*
Arnold S. Relman, MD
Panel 3: Inside the Operating Room
Inside the operating room—balancing the risks and benefi ts of new surgical procedures: A collection of perspectives and panel discussion
Joel D. Cooper, MD; Ralph V. Clayman, MD; Thomas M. Krummel, MD; Philip R. Schauer, MD; Christopher Thompson, MD, MHES; and Jonathan D. Moreno, PhD
How should we introduce and evaluate new procedures?—Joel D. Cooper, MD
Idea to implementation: A personal perspective on the development of laparoscopic nephrectomy—Ralph V. Clayman, MD
Special perspectives in infants and children—Thomas M. Krummel, MD
Bariatric surgery: What role for ethics as established procedures approach new frontiers?—Philip R. Schauer, MD
Natural orifice transluminal endoscopic surgery: Too much too soon?—Christopher Thompson, MD, MHES
Panel discussion—Moderated by Jonathan D. Moreno, PhD
Keynote Address
Will the United States maintain its position as a world leader in medical technology?
Thomas J. Fogarty, MD
Panel 4: Outside the Operating Room
Outside the operating room—economic, regulatory, and legal challenges: A collection of perspectives and panel discussion
Lawrence K. Altman, MD; Michael A. Mussallem; Rebecca Dresser, JD; Paul A. Lombardo, PhD, JD; Peter A. Ubel, MD; and Christopher L. White, Esq
Preface—Lawrence K. Altman, MD (Moderator)
A device company perspective: Serving patients is the key to sustainable success—Michael A. Mussallem
A regulatory and legal perspective: Issues in off-label device use—Rebecca Dresser, JD
A historical perspective: The more things change, the more they remain the same—Paul A. Lombardo, PhD, JD
An economic value perspective: Setting limits on health care can be ethical—Peter A. Ubel, MD
An industry perspective: Proactive self-regulation through an industry code of ethics—Christopher L. White, Esq
Panel discussion—Moderated by Lawrence K. Altman, MD
Panel 5: New Surgical Devices and Ethical Challenges
New surgical devices and ethical challenges: A collection of perspectives and panel discussion
Daniel Schultz, MD; Mary H. McGrath, MD, MPH; Thomas H. Murray, PhD; Roy K. Greenberg, MD; and Thomas J. Fogarty, MD
An FDA perspective on device regulation—Daniel Schultz, MD
Responsibilities of the media, FDA, and professional societies—Mary H. McGrath, MD, MPH
Promoting swift, safe, and smart innovation—Thomas H. Murray, PhD
Panel discussion—Moderated by Roy K. Greenberg, MD
