Moderator
Nina Totenberg
Legal Affairs Correspondent, National Public Radio, Washington, DC

Panelists
Philip A. Pizzo, MD
Dean and Professor of Pediatrics and of Microbiology and Immunology, Stanford University School of Medicine, Stanford, CA

Thomas P. Stossel, MD
Professor of Medicine, Harvard Medical School, Boston, MA

P. Roy Vagelos, MD
Chairman, Regeneron Pharmaceuticals, Inc.; Chairman, Theravance, Inc.; Former CEO, Merck & Co., Inc.

Dr. Stossel reported that he has ownership interests in ZymeQuest, Inc., and in Critical Biologics Corp.; has intellectual property rights in Critical Biologics Corp.; has received consulting/advisory fees from Merck, Inc.; has received honoraria from Pfizer, Inc.; and has received royalties from Lippincott Williams & Wilkins.

All other participants reported that they have no financial interests, relationships, or affiliations that pose a potential conflict of interest with this article.

Moderator
Nina Totenberg
Legal Affairs Correspondent, National Public Radio, Washington, DC

Panelists
Philip A. Pizzo, MD
Dean and Professor of Pediatrics and of Microbiology and Immunology, Stanford University School of Medicine, Stanford, CA

Thomas P. Stossel, MD
Professor of Medicine, Harvard Medical School, Boston, MA

P. Roy Vagelos, MD
Chairman, Regeneron Pharmaceuticals, Inc.; Chairman, Theravance, Inc.; Former CEO, Merck & Co., Inc.

Dr. Stossel reported that he has ownership interests in ZymeQuest, Inc., and in Critical Biologics Corp.; has intellectual property rights in Critical Biologics Corp.; has received consulting/advisory fees from Merck, Inc.; has received honoraria from Pfizer, Inc.; and has received royalties from Lippincott Williams & Wilkins.

All other participants reported that they have no financial interests, relationships, or affiliations that pose a potential conflict of interest with this article.

Moderator
Nina Totenberg
Legal Affairs Correspondent, National Public Radio, Washington, DC

Panelists
Philip A. Pizzo, MD
Dean and Professor of Pediatrics and of Microbiology and Immunology, Stanford University School of Medicine, Stanford, CA

Thomas P. Stossel, MD
Professor of Medicine, Harvard Medical School, Boston, MA

P. Roy Vagelos, MD
Chairman, Regeneron Pharmaceuticals, Inc.; Chairman, Theravance, Inc.; Former CEO, Merck & Co., Inc.

Dr. Stossel reported that he has ownership interests in ZymeQuest, Inc., and in Critical Biologics Corp.; has intellectual property rights in Critical Biologics Corp.; has received consulting/advisory fees from Merck, Inc.; has received honoraria from Pfizer, Inc.; and has received royalties from Lippincott Williams & Wilkins.

All other participants reported that they have no financial interests, relationships, or affiliations that pose a potential conflict of interest with this article.

Paul A. LaViolette, MBA
Chief Operating Officer, Boston Scientific Corporation, Natick, MA; Member, Board of Directors, and Chairman, Special Committee on Codes of Ethics, AdvaMed

Correspondence: Paul A. LaViolette, Chief Operating Officer, Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760; [email protected]

Acknowledgment: The author is indebted to two individuals for their contributions to concepts discussed in this article: Donald S. Baim, MD, of Boston Scientific, and Christopher L. White of AdvaMed. Dr. Baim has coauthored a manuscript on this topic entitled “Medical Device Development: A Balanced Approach to Managing Conflicts of Interest Encountered by Physicians,” resulting in part from the 3rd Dartmouth Device Development Symposium (3D3), October 27 and 28, 2005.

Mr. LaViolette reported that he has no financial interests, relationships, or affiliations that pose a potential conflict of interest with this article apart from his employment with Boston Scientific Corp., from which he receives a salary and in which he holds ownership interest.

Paul A. LaViolette, MBA
Chief Operating Officer, Boston Scientific Corporation, Natick, MA; Member, Board of Directors, and Chairman, Special Committee on Codes of Ethics, AdvaMed

Correspondence: Paul A. LaViolette, Chief Operating Officer, Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760; [email protected]

Acknowledgment: The author is indebted to two individuals for their contributions to concepts discussed in this article: Donald S. Baim, MD, of Boston Scientific, and Christopher L. White of AdvaMed. Dr. Baim has coauthored a manuscript on this topic entitled “Medical Device Development: A Balanced Approach to Managing Conflicts of Interest Encountered by Physicians,” resulting in part from the 3rd Dartmouth Device Development Symposium (3D3), October 27 and 28, 2005.

Mr. LaViolette reported that he has no financial interests, relationships, or affiliations that pose a potential conflict of interest with this article apart from his employment with Boston Scientific Corp., from which he receives a salary and in which he holds ownership interest.

Paul A. LaViolette, MBA
Chief Operating Officer, Boston Scientific Corporation, Natick, MA; Member, Board of Directors, and Chairman, Special Committee on Codes of Ethics, AdvaMed

Correspondence: Paul A. LaViolette, Chief Operating Officer, Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760; [email protected]

Acknowledgment: The author is indebted to two individuals for their contributions to concepts discussed in this article: Donald S. Baim, MD, of Boston Scientific, and Christopher L. White of AdvaMed. Dr. Baim has coauthored a manuscript on this topic entitled “Medical Device Development: A Balanced Approach to Managing Conflicts of Interest Encountered by Physicians,” resulting in part from the 3rd Dartmouth Device Development Symposium (3D3), October 27 and 28, 2005.

Mr. LaViolette reported that he has no financial interests, relationships, or affiliations that pose a potential conflict of interest with this article apart from his employment with Boston Scientific Corp., from which he receives a salary and in which he holds ownership interest.

Moderator
Nina Totenberg
Legal Affairs Correspondent, National Public Radio, Washington, DC

Panelists
Darrell G. Kirch, MD
President and CEO, Association of American Medical Colleges, Washington, DC

Paul A. LaViolette, MBA
Chief Operating Officer, Boston Scientific Corporation, Natick, MA; Member, Board of Directors, and Chairman, Special Committee on Codes of Ethics, AdvaMed

Norka Ruiz Bravo, PhD
Deputy Director for Extramural Research, National Institutes of Health, Bethesda, MD

Mr. LaViolette reported that he has no financial interests or relationships that pose a potential conflict of interest with this article apart from his employment with Boston Scientific Corp., from which he receives a salary and in which he holds ownership interest.

All other participants reported that they have no financial interests, relationships, or affiliations that pose a potential conflict of interest with this article.

Moderator
Nina Totenberg
Legal Affairs Correspondent, National Public Radio, Washington, DC

Panelists
Darrell G. Kirch, MD
President and CEO, Association of American Medical Colleges, Washington, DC

Paul A. LaViolette, MBA
Chief Operating Officer, Boston Scientific Corporation, Natick, MA; Member, Board of Directors, and Chairman, Special Committee on Codes of Ethics, AdvaMed

Norka Ruiz Bravo, PhD
Deputy Director for Extramural Research, National Institutes of Health, Bethesda, MD

Mr. LaViolette reported that he has no financial interests or relationships that pose a potential conflict of interest with this article apart from his employment with Boston Scientific Corp., from which he receives a salary and in which he holds ownership interest.

All other participants reported that they have no financial interests, relationships, or affiliations that pose a potential conflict of interest with this article.

Moderator
Nina Totenberg
Legal Affairs Correspondent, National Public Radio, Washington, DC

Panelists
Darrell G. Kirch, MD
President and CEO, Association of American Medical Colleges, Washington, DC

Paul A. LaViolette, MBA
Chief Operating Officer, Boston Scientific Corporation, Natick, MA; Member, Board of Directors, and Chairman, Special Committee on Codes of Ethics, AdvaMed

Norka Ruiz Bravo, PhD
Deputy Director for Extramural Research, National Institutes of Health, Bethesda, MD

Mr. LaViolette reported that he has no financial interests or relationships that pose a potential conflict of interest with this article apart from his employment with Boston Scientific Corp., from which he receives a salary and in which he holds ownership interest.

All other participants reported that they have no financial interests, relationships, or affiliations that pose a potential conflict of interest with this article.

Moderator and Author of Case Study 2
Claudia R. Adkison, JD, PhD
Executive Associate Dean, Administration and Faculty Affairs, Emory University School of Medicine, Atlanta, GA

Author of Case Study 1
Michael J. Meehan, Esq
Senior Counsel and Corporate Assistant Secretary, Cleveland Clinic, Cleveland, OH

Panelists
Gail H. Cassell, PhD, DSc (hon)
Vice President, Scientific Affairs, and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company, Indianapolis, IN

Jeffrey P. Kahn, PhD, MPH
Maas Family Chair in Bioethics and Director, Center for Bioethics, University of Minnesota, Minneapolis, MN

Philip A. Pizzo, MD
Dean and Professor of Pediatrics and of Microbiology and Immunology, Stanford University School of Medicine, Stanford, CA

Thomas P. Stossel, MD
Professor of Medicine, Harvard Medical School, Boston, MA

Dr. Cassell reported that she receives a salary, grant/research support, and stock options through her employment with Eli Lilly and Company.

Dr. Stossel reported that he has ownership interests in ZymeQuest, Inc., and in Critical Biologics Corp.; has intellectual property rights in Critical Biologics Corp.; has received consulting/advisory fees from Merck, Inc.; has received honoraria from Pfizer, Inc.; and has received royalties from Lippincott Williams & Wilkins.

All other participants reported that they have no financial interests, relationships, or affiliations that pose a potential conflict of interest with this article.

Moderator and Author of Case Study 2
Claudia R. Adkison, JD, PhD
Executive Associate Dean, Administration and Faculty Affairs, Emory University School of Medicine, Atlanta, GA

Author of Case Study 1
Michael J. Meehan, Esq
Senior Counsel and Corporate Assistant Secretary, Cleveland Clinic, Cleveland, OH

Panelists
Gail H. Cassell, PhD, DSc (hon)
Vice President, Scientific Affairs, and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company, Indianapolis, IN

Jeffrey P. Kahn, PhD, MPH
Maas Family Chair in Bioethics and Director, Center for Bioethics, University of Minnesota, Minneapolis, MN

Philip A. Pizzo, MD
Dean and Professor of Pediatrics and of Microbiology and Immunology, Stanford University School of Medicine, Stanford, CA

Thomas P. Stossel, MD
Professor of Medicine, Harvard Medical School, Boston, MA

Dr. Cassell reported that she receives a salary, grant/research support, and stock options through her employment with Eli Lilly and Company.

Dr. Stossel reported that he has ownership interests in ZymeQuest, Inc., and in Critical Biologics Corp.; has intellectual property rights in Critical Biologics Corp.; has received consulting/advisory fees from Merck, Inc.; has received honoraria from Pfizer, Inc.; and has received royalties from Lippincott Williams & Wilkins.

All other participants reported that they have no financial interests, relationships, or affiliations that pose a potential conflict of interest with this article.

Moderator and Author of Case Study 2
Claudia R. Adkison, JD, PhD
Executive Associate Dean, Administration and Faculty Affairs, Emory University School of Medicine, Atlanta, GA

Author of Case Study 1
Michael J. Meehan, Esq
Senior Counsel and Corporate Assistant Secretary, Cleveland Clinic, Cleveland, OH

Panelists
Gail H. Cassell, PhD, DSc (hon)
Vice President, Scientific Affairs, and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company, Indianapolis, IN

Jeffrey P. Kahn, PhD, MPH
Maas Family Chair in Bioethics and Director, Center for Bioethics, University of Minnesota, Minneapolis, MN

Philip A. Pizzo, MD
Dean and Professor of Pediatrics and of Microbiology and Immunology, Stanford University School of Medicine, Stanford, CA

Thomas P. Stossel, MD
Professor of Medicine, Harvard Medical School, Boston, MA

Dr. Cassell reported that she receives a salary, grant/research support, and stock options through her employment with Eli Lilly and Company.

Dr. Stossel reported that he has ownership interests in ZymeQuest, Inc., and in Critical Biologics Corp.; has intellectual property rights in Critical Biologics Corp.; has received consulting/advisory fees from Merck, Inc.; has received honoraria from Pfizer, Inc.; and has received royalties from Lippincott Williams & Wilkins.

All other participants reported that they have no financial interests, relationships, or affiliations that pose a potential conflict of interest with this article.

Moderator
Jeffrey P. Kahn, PhD, MPH
Maas Family Chair in Bioethics and Director, Center for Bioethics, University of Minnesota, Minneapolis, MN

Panelists
Bernard A. Schwetz, DVM, PhD
Director, Office for Human Research Protections, US Department of Health and Human Services, Washington, DC

James G. Sheehan
Associate US Attorney, US Attorney’s Office, US Department of Justice, Philadelphia, PA

Drs. Kahn and Schwetz reported that they have no financial interests, relationships, or affiliations that pose a potential conflict of interest with this article.

Mr. Sheehan reported no such interests, relationships, or affiliations apart from his salary from the US Department of Justice.

Moderator
Jeffrey P. Kahn, PhD, MPH
Maas Family Chair in Bioethics and Director, Center for Bioethics, University of Minnesota, Minneapolis, MN

Panelists
Bernard A. Schwetz, DVM, PhD
Director, Office for Human Research Protections, US Department of Health and Human Services, Washington, DC

James G. Sheehan
Associate US Attorney, US Attorney’s Office, US Department of Justice, Philadelphia, PA

Drs. Kahn and Schwetz reported that they have no financial interests, relationships, or affiliations that pose a potential conflict of interest with this article.

Mr. Sheehan reported no such interests, relationships, or affiliations apart from his salary from the US Department of Justice.

Moderator
Jeffrey P. Kahn, PhD, MPH
Maas Family Chair in Bioethics and Director, Center for Bioethics, University of Minnesota, Minneapolis, MN

Panelists
Bernard A. Schwetz, DVM, PhD
Director, Office for Human Research Protections, US Department of Health and Human Services, Washington, DC

James G. Sheehan
Associate US Attorney, US Attorney’s Office, US Department of Justice, Philadelphia, PA

Drs. Kahn and Schwetz reported that they have no financial interests, relationships, or affiliations that pose a potential conflict of interest with this article.

Mr. Sheehan reported no such interests, relationships, or affiliations apart from his salary from the US Department of Justice.

Moderator
Susan H. Ehringhaus, JD
Associate General Counsel for Regulatory Affairs, Association of American Medical Colleges, Washington, DC

Panelists
Edward D. Miller, MD
Dean of the Medical Faculty, Johns Hopkins School of Medicine, and CEO, Johns Hopkins Medicine, Baltimore, MD

Edward Soule, CPA, PhD
Associate Professor, McDonough School of Business, Georgetown University,Washington, DC

All participants reported that they have no financial interests, relationships, or affiliations that pose a potential conflict of interest with this article.

Moderator
Susan H. Ehringhaus, JD
Associate General Counsel for Regulatory Affairs, Association of American Medical Colleges, Washington, DC

Panelists
Edward D. Miller, MD
Dean of the Medical Faculty, Johns Hopkins School of Medicine, and CEO, Johns Hopkins Medicine, Baltimore, MD

Edward Soule, CPA, PhD
Associate Professor, McDonough School of Business, Georgetown University,Washington, DC

All participants reported that they have no financial interests, relationships, or affiliations that pose a potential conflict of interest with this article.

Moderator
Susan H. Ehringhaus, JD
Associate General Counsel for Regulatory Affairs, Association of American Medical Colleges, Washington, DC

Panelists
Edward D. Miller, MD
Dean of the Medical Faculty, Johns Hopkins School of Medicine, and CEO, Johns Hopkins Medicine, Baltimore, MD

Edward Soule, CPA, PhD
Associate Professor, McDonough School of Business, Georgetown University,Washington, DC

All participants reported that they have no financial interests, relationships, or affiliations that pose a potential conflict of interest with this article.

Monica Colvin-Adams, MD
Assistant Professor of Medicine/Cardiology; Medical Director, Cardiac Transplantation, Department of Medicine, University of Minnesota, Minneapolis, MN

Anne L. Taylor, MD
Professor of Medicine/Cardiology and Associate Dean for Faculty Affairs, University of Minnesota Medical School; Codirector, University of Minnesota National Center of Excellence in Women’s Health; Chair, Steering Committee, African-American Heart Failure Trial (A-HeFT)

Address: Anne L. Taylor, MD, University of Minnesota Medical School, C694 Mayo Memorial Building, Mayo Mail Code 293, 420 Delaware Street, S.E., Minneapolis, MN 55455; e-mail: [email protected]

Dr. Taylor has indicated that she has received research support and consulting fees from the NitroMed corporation, which also sponsored the African-American Heart Failure Trial.

Monica Colvin-Adams, MD
Assistant Professor of Medicine/Cardiology; Medical Director, Cardiac Transplantation, Department of Medicine, University of Minnesota, Minneapolis, MN

Anne L. Taylor, MD
Professor of Medicine/Cardiology and Associate Dean for Faculty Affairs, University of Minnesota Medical School; Codirector, University of Minnesota National Center of Excellence in Women’s Health; Chair, Steering Committee, African-American Heart Failure Trial (A-HeFT)

Address: Anne L. Taylor, MD, University of Minnesota Medical School, C694 Mayo Memorial Building, Mayo Mail Code 293, 420 Delaware Street, S.E., Minneapolis, MN 55455; e-mail: [email protected]

Dr. Taylor has indicated that she has received research support and consulting fees from the NitroMed corporation, which also sponsored the African-American Heart Failure Trial.

Monica Colvin-Adams, MD
Assistant Professor of Medicine/Cardiology; Medical Director, Cardiac Transplantation, Department of Medicine, University of Minnesota, Minneapolis, MN

Anne L. Taylor, MD
Professor of Medicine/Cardiology and Associate Dean for Faculty Affairs, University of Minnesota Medical School; Codirector, University of Minnesota National Center of Excellence in Women’s Health; Chair, Steering Committee, African-American Heart Failure Trial (A-HeFT)

Address: Anne L. Taylor, MD, University of Minnesota Medical School, C694 Mayo Memorial Building, Mayo Mail Code 293, 420 Delaware Street, S.E., Minneapolis, MN 55455; e-mail: [email protected]

Dr. Taylor has indicated that she has received research support and consulting fees from the NitroMed corporation, which also sponsored the African-American Heart Failure Trial.