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Supplement Editor:
Guy M. Chisolm III, PhD
Contents
From the editor
The rapidly changing landscape of biomedical conflicts of interest
Guy M. Chisolm III, PhD, Vice Chairman, Lerner Research Institute, and Professor, Department of Cell Biology, Cleveland Clinic
Opening comments
The mandate of innovation management
Delos M. Cosgrove, MD, CEO and President, Cleveland Clinic
Research, Innovation, and Safety: Doing the Right Thing
Prologue: A case study in biomedical conflicts
Nina Totenberg, Legal Affairs Correspondent, National Public Radio
Fostering innovation without compromising integrity
Philip A. Pizzo, MD, Dean and Professor of Pediatrics and of Microbiology and Immunology, Stanford University School of Medicine
Innovation and industry-academia interactions:Where conflicts arise and measures to avoid them
P. Roy Vagelos, MD, Chairman, Regeneron Pharmaceuticals, Inc.; Chairman, Theravance, Inc.; Former CEO, Merck & Co., Inc.
Overregulation of conflicts hinders medical progress
Thomas P. Stossel, MD, Professor of Medicine, Harvard Medical School
Panel discussion: Research, innovation, and safety: Doing the right thing
Moderated by Nina Totenberg, Legal Affairs Correspondent, National Public Radio
Panelists: Philip A. Pizzo, MD; Thomas P. Stossel, MD; and P. Roy Vagelos, MD
Guiding Principles:Where Are We Headed?
Conflict-of-interest management: Efforts and insights from the Association of American Medical Colleges
Darrell G. Kirch, MD, President and CEO, Association of American Medical Colleges
Medical devices and conflict of interest: Unique issues and an industry code to address them
Paul A. LaViolette, MBA, Chief Operating Officer, Boston Scientific Corporation; Member, Board of Directors, and Chairman, Special Committee on Codes of Ethics, AdvaMed
The challenge for NIH ethics policies: Preserving public trust and biomedical progress
Norka Ruiz Bravo, PhD, Deputy Director for Extramural Research, National Institutes of Health
Panel discussion: Guiding principles:Where are we headed?
Moderated by Nina Totenberg, Legal Affairs Correspondent, National Public Radio
Panelists: Darrell G. Kirch, MD; Paul A. LaViolette, MBA; and Norka Ruiz Bravo, PhD
Keynote Address
Building and retaining trust in the biomedical community
Dick Thornburgh, Counsel, K & L Gates; Former Governor of Pennsylvania; Former Attorney General of the United States
Applications in the Real World: Defining Boundaries and Managing Innovation
Interactions of the public and private sectors in drug development: Boundaries to protect scientific values while preserving innovation
Gail H. Cassell, PhD, DSc (hon), Vice President, Scientific Affairs, and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company
Beyond disclosure: The necessity of trust in biomedical research
Jeffrey P. Kahn, PhD, MPH, Maas Family Chair in Bioethics and Director, Center for Bioethics, University of Minnesota
Panel discussion: Applications in the real world: Case studies in defining boundaries and managing innovation
Moderated by Claudia R. Adkison, JD, PhD, Executive Associate Dean, Administration and Faculty Affairs, Emory University School of Medicine
Case studies submitted by Michael J. Meehan, Esq., Senior Counsel and Corporate Assistant Secretary, Cleveland Clinic, and Claudia R. Adkison, JD, PhD
Panelists: Gail H. Cassell, PhD, DSc (hon); Jeffrey P. Kahn, PhD, MPH; Philip A. Pizzo, MD; and Thomas P. Stossel, MD
Conflicts, Compliance, and Enforcement: Government Priorities and Initiatives
Protecting subjects without hampering research progress: Guidance from the Office for Human Research Protections
Bernard A. Schwetz, DVM, PhD, Director, Office for Human Research Protections, US Department of Health and Human Services
Fraud, conflict of interest, and other enforcement issues in clinical research
James G. Sheehan, Associate US Attorney, US Attorney’s Office, US Department of Justice
Panel discussion: Conflicts, compliance, and enforcement: Government priorities and initiatives
Moderated by Jeffrey P. Kahn, PhD, MPH, Maas Family Chair in Bioethics and Director, Center for Bioethics, University of Minnesota
Panelists: Bernard A. Schwetz, DVM, PhD, and James G. Sheehan
Guidelines and Performance: Creating a Culture of Ethics
Creating an institutional conflict-of-interest policy at Johns Hopkins: Progress and lessons learned
Edward D. Miller, MD, Dean of the Medical Faculty, Johns Hopkins School of Medicine; CEO, Johns Hopkins Medicine
Managing ethical performance in organizations: Insights from the corporate world
Edward Soule, CPA, PhD, Associate Professor, McDonough School of Business, Georgetown University
Panel discussion: Guidelines and performance: Creating a culture of ethics
Moderated by Susan H. Ehringhaus, JD, Associate General Counsel for Regulatory Affairs, Association of American Medical Colleges
Panelists: Edward D. Miller, MD, and Edward Soule, CPA, PhD
Articles in these proceedings were developed by the Cleveland Clinic Journal of Medicine staff from transcripts of audiotaped presentations at the “National Dialogue on Biomedical Conflicts of Interest and Innovation Management” and then reviewed and revised by the respective speakers.
Supplement Editor:
Guy M. Chisolm III, PhD
Contents
From the editor
The rapidly changing landscape of biomedical conflicts of interest
Guy M. Chisolm III, PhD, Vice Chairman, Lerner Research Institute, and Professor, Department of Cell Biology, Cleveland Clinic
Opening comments
The mandate of innovation management
Delos M. Cosgrove, MD, CEO and President, Cleveland Clinic
Research, Innovation, and Safety: Doing the Right Thing
Prologue: A case study in biomedical conflicts
Nina Totenberg, Legal Affairs Correspondent, National Public Radio
Fostering innovation without compromising integrity
Philip A. Pizzo, MD, Dean and Professor of Pediatrics and of Microbiology and Immunology, Stanford University School of Medicine
Innovation and industry-academia interactions:Where conflicts arise and measures to avoid them
P. Roy Vagelos, MD, Chairman, Regeneron Pharmaceuticals, Inc.; Chairman, Theravance, Inc.; Former CEO, Merck & Co., Inc.
Overregulation of conflicts hinders medical progress
Thomas P. Stossel, MD, Professor of Medicine, Harvard Medical School
Panel discussion: Research, innovation, and safety: Doing the right thing
Moderated by Nina Totenberg, Legal Affairs Correspondent, National Public Radio
Panelists: Philip A. Pizzo, MD; Thomas P. Stossel, MD; and P. Roy Vagelos, MD
Guiding Principles:Where Are We Headed?
Conflict-of-interest management: Efforts and insights from the Association of American Medical Colleges
Darrell G. Kirch, MD, President and CEO, Association of American Medical Colleges
Medical devices and conflict of interest: Unique issues and an industry code to address them
Paul A. LaViolette, MBA, Chief Operating Officer, Boston Scientific Corporation; Member, Board of Directors, and Chairman, Special Committee on Codes of Ethics, AdvaMed
The challenge for NIH ethics policies: Preserving public trust and biomedical progress
Norka Ruiz Bravo, PhD, Deputy Director for Extramural Research, National Institutes of Health
Panel discussion: Guiding principles:Where are we headed?
Moderated by Nina Totenberg, Legal Affairs Correspondent, National Public Radio
Panelists: Darrell G. Kirch, MD; Paul A. LaViolette, MBA; and Norka Ruiz Bravo, PhD
Keynote Address
Building and retaining trust in the biomedical community
Dick Thornburgh, Counsel, K & L Gates; Former Governor of Pennsylvania; Former Attorney General of the United States
Applications in the Real World: Defining Boundaries and Managing Innovation
Interactions of the public and private sectors in drug development: Boundaries to protect scientific values while preserving innovation
Gail H. Cassell, PhD, DSc (hon), Vice President, Scientific Affairs, and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company
Beyond disclosure: The necessity of trust in biomedical research
Jeffrey P. Kahn, PhD, MPH, Maas Family Chair in Bioethics and Director, Center for Bioethics, University of Minnesota
Panel discussion: Applications in the real world: Case studies in defining boundaries and managing innovation
Moderated by Claudia R. Adkison, JD, PhD, Executive Associate Dean, Administration and Faculty Affairs, Emory University School of Medicine
Case studies submitted by Michael J. Meehan, Esq., Senior Counsel and Corporate Assistant Secretary, Cleveland Clinic, and Claudia R. Adkison, JD, PhD
Panelists: Gail H. Cassell, PhD, DSc (hon); Jeffrey P. Kahn, PhD, MPH; Philip A. Pizzo, MD; and Thomas P. Stossel, MD
Conflicts, Compliance, and Enforcement: Government Priorities and Initiatives
Protecting subjects without hampering research progress: Guidance from the Office for Human Research Protections
Bernard A. Schwetz, DVM, PhD, Director, Office for Human Research Protections, US Department of Health and Human Services
Fraud, conflict of interest, and other enforcement issues in clinical research
James G. Sheehan, Associate US Attorney, US Attorney’s Office, US Department of Justice
Panel discussion: Conflicts, compliance, and enforcement: Government priorities and initiatives
Moderated by Jeffrey P. Kahn, PhD, MPH, Maas Family Chair in Bioethics and Director, Center for Bioethics, University of Minnesota
Panelists: Bernard A. Schwetz, DVM, PhD, and James G. Sheehan
Guidelines and Performance: Creating a Culture of Ethics
Creating an institutional conflict-of-interest policy at Johns Hopkins: Progress and lessons learned
Edward D. Miller, MD, Dean of the Medical Faculty, Johns Hopkins School of Medicine; CEO, Johns Hopkins Medicine
Managing ethical performance in organizations: Insights from the corporate world
Edward Soule, CPA, PhD, Associate Professor, McDonough School of Business, Georgetown University
Panel discussion: Guidelines and performance: Creating a culture of ethics
Moderated by Susan H. Ehringhaus, JD, Associate General Counsel for Regulatory Affairs, Association of American Medical Colleges
Panelists: Edward D. Miller, MD, and Edward Soule, CPA, PhD
Articles in these proceedings were developed by the Cleveland Clinic Journal of Medicine staff from transcripts of audiotaped presentations at the “National Dialogue on Biomedical Conflicts of Interest and Innovation Management” and then reviewed and revised by the respective speakers.
Supplement Editor:
Guy M. Chisolm III, PhD
Contents
From the editor
The rapidly changing landscape of biomedical conflicts of interest
Guy M. Chisolm III, PhD, Vice Chairman, Lerner Research Institute, and Professor, Department of Cell Biology, Cleveland Clinic
Opening comments
The mandate of innovation management
Delos M. Cosgrove, MD, CEO and President, Cleveland Clinic
Research, Innovation, and Safety: Doing the Right Thing
Prologue: A case study in biomedical conflicts
Nina Totenberg, Legal Affairs Correspondent, National Public Radio
Fostering innovation without compromising integrity
Philip A. Pizzo, MD, Dean and Professor of Pediatrics and of Microbiology and Immunology, Stanford University School of Medicine
Innovation and industry-academia interactions:Where conflicts arise and measures to avoid them
P. Roy Vagelos, MD, Chairman, Regeneron Pharmaceuticals, Inc.; Chairman, Theravance, Inc.; Former CEO, Merck & Co., Inc.
Overregulation of conflicts hinders medical progress
Thomas P. Stossel, MD, Professor of Medicine, Harvard Medical School
Panel discussion: Research, innovation, and safety: Doing the right thing
Moderated by Nina Totenberg, Legal Affairs Correspondent, National Public Radio
Panelists: Philip A. Pizzo, MD; Thomas P. Stossel, MD; and P. Roy Vagelos, MD
Guiding Principles:Where Are We Headed?
Conflict-of-interest management: Efforts and insights from the Association of American Medical Colleges
Darrell G. Kirch, MD, President and CEO, Association of American Medical Colleges
Medical devices and conflict of interest: Unique issues and an industry code to address them
Paul A. LaViolette, MBA, Chief Operating Officer, Boston Scientific Corporation; Member, Board of Directors, and Chairman, Special Committee on Codes of Ethics, AdvaMed
The challenge for NIH ethics policies: Preserving public trust and biomedical progress
Norka Ruiz Bravo, PhD, Deputy Director for Extramural Research, National Institutes of Health
Panel discussion: Guiding principles:Where are we headed?
Moderated by Nina Totenberg, Legal Affairs Correspondent, National Public Radio
Panelists: Darrell G. Kirch, MD; Paul A. LaViolette, MBA; and Norka Ruiz Bravo, PhD
Keynote Address
Building and retaining trust in the biomedical community
Dick Thornburgh, Counsel, K & L Gates; Former Governor of Pennsylvania; Former Attorney General of the United States
Applications in the Real World: Defining Boundaries and Managing Innovation
Interactions of the public and private sectors in drug development: Boundaries to protect scientific values while preserving innovation
Gail H. Cassell, PhD, DSc (hon), Vice President, Scientific Affairs, and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company
Beyond disclosure: The necessity of trust in biomedical research
Jeffrey P. Kahn, PhD, MPH, Maas Family Chair in Bioethics and Director, Center for Bioethics, University of Minnesota
Panel discussion: Applications in the real world: Case studies in defining boundaries and managing innovation
Moderated by Claudia R. Adkison, JD, PhD, Executive Associate Dean, Administration and Faculty Affairs, Emory University School of Medicine
Case studies submitted by Michael J. Meehan, Esq., Senior Counsel and Corporate Assistant Secretary, Cleveland Clinic, and Claudia R. Adkison, JD, PhD
Panelists: Gail H. Cassell, PhD, DSc (hon); Jeffrey P. Kahn, PhD, MPH; Philip A. Pizzo, MD; and Thomas P. Stossel, MD
Conflicts, Compliance, and Enforcement: Government Priorities and Initiatives
Protecting subjects without hampering research progress: Guidance from the Office for Human Research Protections
Bernard A. Schwetz, DVM, PhD, Director, Office for Human Research Protections, US Department of Health and Human Services
Fraud, conflict of interest, and other enforcement issues in clinical research
James G. Sheehan, Associate US Attorney, US Attorney’s Office, US Department of Justice
Panel discussion: Conflicts, compliance, and enforcement: Government priorities and initiatives
Moderated by Jeffrey P. Kahn, PhD, MPH, Maas Family Chair in Bioethics and Director, Center for Bioethics, University of Minnesota
Panelists: Bernard A. Schwetz, DVM, PhD, and James G. Sheehan
Guidelines and Performance: Creating a Culture of Ethics
Creating an institutional conflict-of-interest policy at Johns Hopkins: Progress and lessons learned
Edward D. Miller, MD, Dean of the Medical Faculty, Johns Hopkins School of Medicine; CEO, Johns Hopkins Medicine
Managing ethical performance in organizations: Insights from the corporate world
Edward Soule, CPA, PhD, Associate Professor, McDonough School of Business, Georgetown University
Panel discussion: Guidelines and performance: Creating a culture of ethics
Moderated by Susan H. Ehringhaus, JD, Associate General Counsel for Regulatory Affairs, Association of American Medical Colleges
Panelists: Edward D. Miller, MD, and Edward Soule, CPA, PhD
Articles in these proceedings were developed by the Cleveland Clinic Journal of Medicine staff from transcripts of audiotaped presentations at the “National Dialogue on Biomedical Conflicts of Interest and Innovation Management” and then reviewed and revised by the respective speakers.
