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DOYLE, Pennsylvania SHEILA JACKSON LEE, Texas BILL LUTHER, Minnesota WALTER H.

BARCIA, Michigan PAUL MCHALE, Pennsylvania EDDIE BERNICE JOHNSON, Texas ALCEE L. RIVERS, Michigan ZOE LOFGREN, California LLOYD DOGGETT, Texas MICHAEL F.

66] Printed for the use of the Committee on Science APR 6 1999 THE HUMAN GENOME PROJECT: HOW PRIVATE SECTOR DEVELOPMENTS AFTECT THE GOVERN- MENT PROGRAM HEARING BEFORE THE SUBCOMMITTEE ON ENERGY AND ENVIRONMENT OF THE COMMITTEE ON SCIENCE U. HOUSE OF REPRESENTATIVES ONE HUNDRED FIFTH CONGRESS SECOND SESSION JUNE 17, 1998 [No. C3 116 Justin Gillis and Rick Weiss, "Private Firm Aims to Beat Government in Gene Plan," The Washington Post, May 12, 1998, p.

66] Printed for the use of the Committee on Science U. GOVERNMENT PRINTING OFFICE 51-217CC WASHINGTON : 1998 For sale by the U. Government Printing Office Superintendent of Documents, Congressional Sales Office, Washington, DC 20402 ISBN 0-16-057661-X COMMITTEE ON SCIENCE F. Al 118 Clive Cookson, "Genetic mapping triggers contest: Academics race private enterprise," The New York Times, May 12, 1998, p.

DOYLE, Pennsylvania DARLENE HOOLEY, Oregon RALPH M. Patrinos, Associate Director of Energy Research for Biological and Environmental Research, U. Department of En- ergy, Washington, DC: Oral Testimony 5 Prepared Testimony 8 Biography 14 Dr. Collins, Director, National Human Genome Research Institute, National Institutes of Health, U. Department of Health and Human Services, Bethesda, MD: Oral Testimony 15 Prepared Testimony 18 Biography 25 Dr. Craig Venter, President and Director, The Institute for Grenomic Research, Rockville, MD: Oral Testimony 26 Prepared Testimony 28 Biography 36 Financial Disclosure 37 Dr. Galas, President and Chief Scientific Officer, Chiroscience R&D Inc., Bothell, WA: Oral Testimony 42 Prepared Testimony 46 Biography 53 Financial Disclosure 54 Dr. Olson, Professor of Medical Genetics and Genetics, Department of Molecular Biotechnology, and Director, Genome Center, University of Washington, Seattle, WA: Oral Testimony 55 Prepared Testimony 58 Biography 64 Financial Disclosure 71 Discussion Reasons for Federal Government To Complete Human Genome Sequenc- ing 72 Refocusing of Federal Human Genome Project 73 Federal Program's Use of Latest Technologies 74 Federal Budget for the Human Genome Project 74 Dr.

COBURN, Oklahoma California, Chairman TIM ROEMER, Indiana PAUL Mc HALE, Pennsylvania MICHAEL F.

C16 120 Nicholas Wade, "International CSrene Project Gets Lift: Wellcome Trust Dou- bles Commitment to Public-Sector Effort," The New York Times, May 12, 1998, p. Haseltine, "Gene-Mapping, Without Tax Money," The New York Times, May 21, 1998, p. Department of Energy and the Human Genome Project, Prepared by the Lawrence Berkeley National Laboratory for the U. Department of Energy, Office of Energy Research, Office of Health and Environmental Research, July 1996 345 Francis Collins and David Galas, "A New Five-Year Plan for the U. Human Genome Program," Science 262, 43 (1993) 380 DOE Human Genome Program Primer on Molecular Genetics, Prepared by the Human Genome Management Information System, Oak Ridge National Laboratory for the U. Department of Energy, Office of Energy Research, Office of Health and Environmental Research, June 1992 390 (VI) THE HUMAN GENOME PROJECT: HOW PRI- VATE SECTOR DEVELOPMENTS AFFECT THE GOVERNMENT PROGRAM WEDNESDAY, JUNE 17, 1998 House of Representatives, Committee on Science, Subcommittee on Energy and Environment, Washington, DC.

FAWELL, Illinois CURT WELDON, Pennsylvania DANA ROHRABACHER, California STEVEN H. EHLERS, Michigan MATT SALMON, Arizona MARK ADAM FOLEY, Florida PHIL ENGLISH, Pennsylvania TOM A.

HASTINGS, Florida *Ranking Minority Member **Vice Chairman (II) CONTENTS Page June 17, 1998 — The Human Genome Project: How Private Sector De- velopments Affect the Government Program Opening Statement by Representative Ken Calvert (CA-43), Chairman, Sub- committee on Energy and Environment, Committee on Science, U. House of Representatives 1 Opening Statement by Representative Tim Roemer (IN-3), Ranking Minority Member, Subcommittee on Energy and Environment, Committee on Science, U. Three Different DOE Laboratory Programs 88 Democratic Member Questions: Difference Between the DOE-NIH and "Shotgun" Human DNA Se- quencing Approaches 89 Role of DOE and NIH in Collaboration with Private-Sector Venture 89 Concerns of International Collaborators About Intellectual Property Rights and Patenting 90 Dr. Collins, Director, National Human Genome Research Institute, National Institutes of Health, U. Department of Health and Human Services: Republican Member Question: Scientific Justification for Completing Government-Funded Sequencing of Entire Human Genome 92 Democratic Member Questions: Difference Between the DOE-NIH and "Shotgun" Human DNA Se- quencing Approaches 93 Role of DOE and NIH in Collaboration with Private-Sector Venture 94 Concerns of International Collaborators About Intellectual Property Rights and Patenting 94 Federal Government's Cost to Completely Sequence the Human Ge- nome 96 Dr. Craig Venter, President and Director, The Institute for Genomic Research: Republican Member Questions: Will the Private Initiative Duplicate the Federal Human Genome Project? HALL, Texas EDDIE BERNICE JOHNSON, Texas ZOE LOFGREN, California ALCEE L. Olson's Criticisms of Private-Sector Venture 75 Ethical, Legal and Social Concerns 77 Patentability of Human Genome 77 Difference Between Federal Human Genome Project and Private-Sector Venture 78 (III) Page Recapturing Private Investment 79 Tension Between Free Market and Information Dissemination 80 Concerns About Public Access to Information 81 Consequences of Intellectual Property/Patient/Privacy Rights 83 Consequences of Private-Sector Venture for Federal Human Genome Project 84 Efficiency of Federal Human Genome Project 84 Appendix 1: Answers to Post-Hearing Questions Submitted by Members of the Subcommittee on Energy and Environment Dr. Patrinos, Associate Director of Energy Research for Biological and Environmental Research, U. Department of En- ergy: Republican Member Questions: Scientific Justification for Completing Government-Funded Sequencing of Entire Human Genome 87 Efficiencies of DOE's Joint Genome Initiative vs. Craig Venter, et al., "Shotgun Sequencing of the Human Genome," Science 280, 1540 (June 5, 1998) 110 Nicholas Wade, "Scientist's Plan: Map All DNA Within 3 Years," The New York Times, May 10, 1998, p. 97 Concern About Release of Data to the Public 98 Recommendations for Restructuring the Federal Human Genome Project 98 Democratic Member Questions: Availability of Genomic Information to the Scientific Community 99 Timeliness of Release of and Compensation for Human DNA Sequence Data 99 Plans to Patent Genomic Sequences 100 Uniqueness of Expressed Sequence Tags 100 Role of DOE and NIH in Collaboration with Private-Sector Venture 101 Restrictions on Researchers' Ability to Obtain Human DNA Sequence Information 101 (IV) Page Relation of New Venture to the Federally-Funded Human Genome Sequencing Effort 102 Dr. Galas, President and Chief Scientific Officer, Chiroscience R&D Inc: Republican Member Questions: Practical Value of Federal Completion of Entire Human Genome Se- quencing Process 103 Democratic Member Questions: Impact on Current Efforts 104 Importance of Genomic Data That May Be Withheld 104 Reasonable Fees and Conditions to Private-Controlled Genetic Informa- tion 104 Rights of Individuals' Privacy and Compensation Issues 105 Dr. Olson, Professor of Medical Grenetics and Genetics, Department of Molecular Biotechnology, and Director, Genome Center, University of Washington: Democratic Member Questions: Concerns About Ability to Access Genomic Information 106 Impact on Current Efforts 107 Importance of Genomic Data That May Be Withheld 107 Reasonable Fees and Conditions to Private-Controlled Genetic Informa- tion 107 Rights of Individuals' Privacy and Compensation Issues 108 Appendix 2: Additional Materials for the Record J.THE HUMAN GENOME PROJECT: HOW PRIVATE SECTOR DEVELOPMENTS AFFECT THE GOVERN- MENT PROGRAM V The Hiian Genoiie Project: How Private Sector Developjients Affect the Governiient Prograu, (No. MORELLA, Maryland CURT WELDON, Pennsylvania DANA ROHRABACHER, California STEVEN SCHIFF, New Mexico JOE BARTON, Texas KEN CALVERT, California ROSCOE G. EHLERS, Michigan DAVE WELDON, Florida MATT SALMON, Arizona THOMAS M. Al 113 Bill Richards, "Perkin-Elmer Jumps Into Race to Decode Genes," The Wall Street Journal, May 11, 1998, p.

HASTINGS, Florida *Ranking Minority Member **Vice Chairman (II) CONTENTS Page June 17, 1998 — The Human Genome Project: How Private Sector De- velopments Affect the Government Program Opening Statement by Representative Ken Calvert (CA-43), Chairman, Sub- committee on Energy and Environment, Committee on Science, U. House of Representatives 1 Opening Statement by Representative Tim Roemer (IN-3), Ranking Minority Member, Subcommittee on Energy and Environment, Committee on Science, U. Three Different DOE Laboratory Programs 88 Democratic Member Questions: Difference Between the DOE-NIH and "Shotgun" Human DNA Se- quencing Approaches 89 Role of DOE and NIH in Collaboration with Private-Sector Venture 89 Concerns of International Collaborators About Intellectual Property Rights and Patenting 90 Dr. Collins, Director, National Human Genome Research Institute, National Institutes of Health, U. Department of Health and Human Services: Republican Member Question: Scientific Justification for Completing Government-Funded Sequencing of Entire Human Genome 92 Democratic Member Questions: Difference Between the DOE-NIH and "Shotgun" Human DNA Se- quencing Approaches 93 Role of DOE and NIH in Collaboration with Private-Sector Venture 94 Concerns of International Collaborators About Intellectual Property Rights and Patenting 94 Federal Government's Cost to Completely Sequence the Human Ge- nome 96 Dr. Craig Venter, President and Director, The Institute for Genomic Research: Republican Member Questions: Will the Private Initiative Duplicate the Federal Human Genome Project?

HALL, Texas EDDIE BERNICE JOHNSON, Texas ZOE LOFGREN, California ALCEE L. Olson's Criticisms of Private-Sector Venture 75 Ethical, Legal and Social Concerns 77 Patentability of Human Genome 77 Difference Between Federal Human Genome Project and Private-Sector Venture 78 (III) Page Recapturing Private Investment 79 Tension Between Free Market and Information Dissemination 80 Concerns About Public Access to Information 81 Consequences of Intellectual Property/Patient/Privacy Rights 83 Consequences of Private-Sector Venture for Federal Human Genome Project 84 Efficiency of Federal Human Genome Project 84 Appendix 1: Answers to Post-Hearing Questions Submitted by Members of the Subcommittee on Energy and Environment Dr. Patrinos, Associate Director of Energy Research for Biological and Environmental Research, U. Department of En- ergy: Republican Member Questions: Scientific Justification for Completing Government-Funded Sequencing of Entire Human Genome 87 Efficiencies of DOE's Joint Genome Initiative vs.

Craig Venter, et al., "Shotgun Sequencing of the Human Genome," Science 280, 1540 (June 5, 1998) 110 Nicholas Wade, "Scientist's Plan: Map All DNA Within 3 Years," The New York Times, May 10, 1998, p.

97 Concern About Release of Data to the Public 98 Recommendations for Restructuring the Federal Human Genome Project 98 Democratic Member Questions: Availability of Genomic Information to the Scientific Community 99 Timeliness of Release of and Compensation for Human DNA Sequence Data 99 Plans to Patent Genomic Sequences 100 Uniqueness of Expressed Sequence Tags 100 Role of DOE and NIH in Collaboration with Private-Sector Venture 101 Restrictions on Researchers' Ability to Obtain Human DNA Sequence Information 101 (IV) Page Relation of New Venture to the Federally-Funded Human Genome Sequencing Effort 102 Dr. Galas, President and Chief Scientific Officer, Chiroscience R&D Inc: Republican Member Questions: Practical Value of Federal Completion of Entire Human Genome Se- quencing Process 103 Democratic Member Questions: Impact on Current Efforts 104 Importance of Genomic Data That May Be Withheld 104 Reasonable Fees and Conditions to Private-Controlled Genetic Informa- tion 104 Rights of Individuals' Privacy and Compensation Issues 105 Dr. Olson, Professor of Medical Grenetics and Genetics, Department of Molecular Biotechnology, and Director, Genome Center, University of Washington: Democratic Member Questions: Concerns About Ability to Access Genomic Information 106 Impact on Current Efforts 107 Importance of Genomic Data That May Be Withheld 107 Reasonable Fees and Conditions to Private-Controlled Genetic Informa- tion 107 Rights of Individuals' Privacy and Compensation Issues 108 Appendix 2: Additional Materials for the Record J.

THE HUMAN GENOME PROJECT: HOW PRIVATE SECTOR DEVELOPMENTS AFFECT THE GOVERN- MENT PROGRAM V The Hiian Genoiie Project: How Private Sector Developjients Affect the Governiient Prograu, (No. MORELLA, Maryland CURT WELDON, Pennsylvania DANA ROHRABACHER, California STEVEN SCHIFF, New Mexico JOE BARTON, Texas KEN CALVERT, California ROSCOE G. EHLERS, Michigan DAVE WELDON, Florida MATT SALMON, Arizona THOMAS M. Al 113 Bill Richards, "Perkin-Elmer Jumps Into Race to Decode Genes," The Wall Street Journal, May 11, 1998, p.

HEARING BEFORE THE SUBCOMMITTEE ON ENERGY AND ENVIRONMENT • OF THE COMMITTEE ON SCIENCE U. HOUSE OF REPRESENTATIVES ONE HUNDRED FIFTH CONGRESS SECOND SESSION JUNE 17, 1998 [No. DAVIS, Virginia GIL GUTKNECHT, Minnesota MARK FOLEY, Florida THOMAS W. "CHIP' PICKERING, Mississippi CHRIS CANNON, Utah KEVIN BRADY, Texas MERRILL COOK, Utah PHIL ENGLISH, Pennsylvania GEORGE R. B6 115 Nicholas Wade, "Beyond Sequencing of Human DNA," The New York Times, May 12, 1998, p.