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Realizing the Potential of Pharmacogenomics: Opportunities and Challenges Realizing the Potential of Pharmacogenomics: Opportunities and Challenges Report of the Secretary’s Advisory Committee on Genetics, Health, and Society May 2008 A pdf version of this report is available at http://www4.od.nih.gov/oba/sacghs/reports/SACGHS_PGx_report.pdf Realizing the Potential of Pharmacogenomics: Opportunities and Challenges Report of the Secretary’s Advisory Committee on Genetics, Health, and Society May 2008 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Secretary’s Advisory Committee on Genetics, Health, and Society 6705 Rockledge Drive Suite 750, MSC 7985 Bethesda, MD 20892-7985 301-496-9838 301-496-9839 Fax http://www4.od.nih.gov/oba/sacghs.htm May 12, 2008 The Honorable Michael O. Leavitt Secretary of Health and Human Services 200 Independence Avenue, S.W. Washington, DC 20201 Dear Secretary Leavitt: On behalf of the Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) and in keeping with our mandate to provide advice on the broad range of policy issues raised by the development and use of genetic technologies, I am pleased to submit our report, Realizing the Potential of Pharmacogenomics: Opportunities and Challenges. The report explores the potential for pharmacogenomics (PGx) to advance the development of diagnostic, therapeutic, and preventive strategies to improve the safety, effectiveness, and quality of health care. It identifies untapped opportunities and critical barriers associated with PGx research and makes policy recommendations to enhance the development of PGx applications and their integration into clinical practice and public health. The report is the culmination of 3 years of factfinding, public consultation, analysis, and deliberation by the Committee. Many people shared their knowledge, expertise, and perspectives with us and deepened our understanding of the current scientific, technological, clinical, and policy landscapes and the paths forward for realizing the potential of pharmacogenomics. We are indebted to them for their contributions to the report’s development. We appreciate the opportunity to address this important topic and hope that our input will prove helpful to you and the Department. Sincerely, Steven Teutsch, M.D., M.P.H. Reed V. Tuckson, M.D. SACGHS Chair SACGHS Chair Emeritus About SACGHS The Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) was first chartered in 2002 by the Secretary of Health and Human Services (HHS) as a public forum for deliberation on the broad range of policy issues raised by the development and use of genetic tests and, as warranted, to provide advice on these issues. The charter sets out the following specific functions of the Committee: • Assessing how genetic and genomic technologies are being integrated into health care and public health; • Studying the clinical, public health, ethical, economic, legal, and societal implications of genetic and genomic technologies and applications; • Identifying opportunities and gaps in research and in data collection and analysis efforts; • Examining the impact of current patent policy and licensing practices on access to genetic and genomic technologies; • Analyzing uses of genetic information in education, employment, insurance, and law; and • Serving as a public forum for discussion of issues raised by genetic and genomic technologies. Structurally, SACGHS consists of up to 17 individuals from around the Nation who have expertise in disciplines relevant to genetics and genetic technologies. These disciplines include biomedical sciences, human genetics, health care delivery, evidence-based practice, public health, behavioral sciences, social sciences, health services research, health policy, health disparities, ethics, economics, law, health care financing, consumer issues, and other relevant fields. At least two of the members are specifically selected for their knowledge of consumer issues and concerns and the views and perspectives of the general public. Representatives of at least 19 Federal department or agencies also sit on SACGHS in an ex officio (nonvoting) capacity. The departments and agencies are the Department of Commerce, Department of Defense, Department of Education, Department of Energy, Administration for Children and Families (HHS), Agency for Healthcare Research and Quality (HHS), Centers for Disease Control and Prevention (HHS), Centers for Medicare & Medicaid Services (HHS), Food and Drug Administration (HHS), Health Resources and Services Administration (HHS), National Institutes of Health (HHS), Office for Civil Rights (HHS), Office for Human Research Protections (HHS), Office of Public Health and Science (HHS), Department of Justice, Department of Labor, Department of Veterans Affairs, Equal Employment Opportunity Commission, and Federal Trade Commission. Report of the Secretary’s Advisory Committee on Genetics, Health, and Society i ii Realizing the Potential of Pharmacogenomics: Opportunities and Challenges SACGHS Roster Chairs Steven Teutsch, MD, MPH (2006-2010) (Current Chair) Reed V. Tuckson, MD (2003-2008) (Former Chair) Executive Director Executive Vice President Outcomes Research & Management Chief of Medical Affairs Merck & Co., Inc. UnitedHealth Group West Point, PA Minnetonka, MN Members Mara Aspinall, MBA (2007-2011)* James P. Evans, MD, PhD (2005-2009) Senior Advisor Associate Professor of Genetics and Medicine Genzyme Genetics Director of Clinical Cancer Genetics and the Bryson Program Genezyme Corporation in Human Genetics Westborough, MA The University of North Carolina at Chapel Hill Chapel Hill, NC Sylvia Mann Au, MS, CGC (2005-2009) Hawaii State Genetics Coordinator Andrea Ferreira-Gonzalez, PhD (2006-2010) Genetics Program Professor of Pathology and Director of Molecular Diagnostics Hawaii Department of Health Laboratory Honolulu, HI Virginia Commonwealth University Richmond, VA Cynthia E. Berry, JD (2003-2007)* Partner Kevin T. FitzGerald, SJ, PhD, PhD (2005-2008) Powell Goldstein Frazer & Murphy David P. Lauler Chair in Catholic Health Care Ethics Washington, DC Research Associate Professor Department of Oncology Paul Billings, MD, PhD (appt pending)* Georgetown University Medical Center President and Chief Executive Officer Washington, DC CellPoint Diagnostics Mountain View, CA Debra G.B. Leonard, MD, PhD (2003-2006)* Chairman Vice-Chair of Laboratory Medicine Signature Genomic Laboratories New York Presbyterian Hospital Spokane, WA New York, NY Chira Chen (2005-2007)* Julio Licinio, MD (2007-2009) Staff Research Associate Professor and Chairman University of California, San Francisco, Helen Diller Family Department of Psychiatry and Behavioral Sciences Comprehensive Cancer Center University of Miami Leonard M. Miller School of Medicine San Francisco, CA Miami, FL Rochelle Dreyfus, MA, JD (2007-2011)* Pauline Newman Professor of Law New York University School of Law New York, NY * The appointments of these SACGHS members had either ended before or had not yet begun at the time the recommendations were finalized. Therefore, they did not participate in the vote on the final recommendations. However, they did participate in the deliberations of the report and draft recommendations. Report of the Secretary’s Advisory Committee on Genetics, Health, and Society iii Agnes Masny, RN, MPH, MSN (2003-2006)* Huntington F. Willard, PhD (2003-2007)* Adjunct Assistant Professor of Nursing Director Temple University College of Allied Health Professionals Duke Institute for Genome Sciences & Policy Research Assistant and Nurse Practitioner Vice Chancellor for Genome Sciences Family Risk Assessment Program Duke University Medical Center Fox Chase Cancer Center Durham, NC Philadelphia, PA Marc S. Williams, MD, FAAP, FACMG (2006-2010) Barbara Burns McGrath, RN, PhD (2006-2010) Director Research Associate Professor Clinical Genetics Institute University of Washington School of Nursing Intermountain Healthcare Seattle, WA Salt Lake City, UT Paul Steven Miller, JD (appt pending)* Emily S. Winn-Deen, PhD (2003-2006)* Director of Disability Studies Program Vice President, Strategic Planning and Business Development Henry M. Jackson Professor of Law Cepheid University of Washington School of Law Sunnyvale, CA Seattle, WA Paul Wise, MD, MPH (2007-2011)* Joseph Telfair, DrPH, MSW, MPH (2004-2008) Richard E. Behrman Professor of Child Health and Society Professor Stanford University Public Health Research and Practice Stanford, CA Department of Public Health Education The University of North Carolina at Greensboro Greensboro, NC * The appointments of these SACGHS members had either ended before or had not yet begun at the time the recommendations were finalized. Therefore, they did not participate in the vote on the final recommendations. However, they did participate in the deliberations of the report and draft recommendations. iv Realizing the Potential of Pharmacogenomics: Opportunities and Challenges Ex Officio Members Thomas Alexander, JD Robinsue Frohboese, JD, PhD Department of Labor Office for Civil Rights Department of Health and Human Services Michael Amos, PhD Department of Commerce Denise Geolot, PhD, RN, FAAN Health Resources and Services Administration Michael Carome, MD Department of Health and Human Services Office for Human Research Protections Department of Health and Human Services Steven I. Gutman, MD, MBA Food and Drug Administration Francis Collins, MD, PhD Department of Health and Human Services National Institutes of Health Department of Health and Human Services Inyang Isong, MD, MPH Office of
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