The human genome project : how private sector developments affect the government program : hearing before the Subcommittee on Energy and Environment of the Committee on Science, U.S. House of Representatives, One Hundred Fifth Congress, second session, Ju

444 Pages·1998·18.7 MB·English

by  United States. Congress. House. Committee on Science. Subcommittee on Energy and Environment

THE HUMAN GENOME PROJECT: HOW PRIVATE
SECTOR DEVELOPMENTS AFFECT THE GOVERN-
MENT PROGRAM
The Hiian Genoiie Project: How Private Sector
V Developjients Affect the Governiient Prograu, H(No.EARING
BEFORE THE
SUBCOMMITTEE ON ENERGY AND ENVIRONMENT
• OF THE
COMMITTEE ON SCIENCE
HOUSE OF REPRESENTATIVES
U.S.
ONE HUNDRED FIFTH CONGRESS
SECOND SESSION
JUNE 17, 1998
[No. 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
HOUSE OF REPRESENTATIVES
U.S.
ONE HUNDRED FIFTH CONGRESS
SECOND SESSION
JUNE 17, 1998
[No. 66]
Printed for the use of the Committee on Science
U.S. GOVERNMENT PRINTING OFFICE
51-217CC WASHINGTON 1998
:
ForsalebytheU.S.GovernmentPrintingOffice
SuperintendentofDocuments,CongressionalSalesOffice,Washington,DC 20402
ISBN 0-16-057661-X
COMMITTEE ON SCIENCE
F. JAMES SENSENBRENNER. Jr., Wisconsin, Chairman
SHERWOOD L. BOEHLERT, New York GEORGE E. BROWN, Jr., California RMM*
HARRIS W. FAWELL, Illinois RALPH M. HALL, Texas
CONSTANCE A. MORELLA, Maryland BART GORDON, Tennessee
DCUARNTAWREOLHDROANB,ACPHeEnnRs,ylCvaalniifaornia JTIAMMERSOEA.METRR,AFIInCdAiaNnTa, Jr., Ohio
STEVEN SCHIFF, New Mexico ROBERT E. "BUD" CRAMER, Jr., Alabama
JOE BARTON, Texas JAMES A. BARCIA, Michigan
KEN CALVERT, California PAUL MCHALE, Pennsylvania
ROSCOE G. BARTLETT, Maryland EDDIE BERNICE JOHNSON, Texas
VERNON J. EHLERS, Michigan ALCEE L. HASTINGS, Florida
DAVE WELDON, Florida LYNN N. RIVERS, Michigan
MATT SALMON, Arizona ZOE LOFGREN, California
THOMAS M. DAVIS, Virginia LLOYD DOGGETT, Texas
GIL GUTKNECHT, Minnesota MICHAEL F. DOYLE, Pennsylvania
MARK FOLEY, Florida SHEILA JACKSON LEE, Texas
THOMAS W. EWING, Illinois BILL LUTHER, Minnesota
CHARLES W. "CHIP' PICKERING, WALTER H. CAPPS, California
Mississippi DEBBIE STABENOW, Michigan
CHRIS CANNON, Utah BOB ETHERIDGE, North Carolina
KEVIN BRADY, Texas NICK LAMPSON, Texas
MERRILL COOK, Utah DARLENE HOOLEY, Oregon
PHIL ENGLISH, Pennsylvania
GEORGE R. NETHERCUTT, JR.,
Washington
TOM A. COBURN, Oklahoma
PETE SESSIONS. Texas
Todd R. Schultz, ChiefofStaff
Barry C. Beringer, ChiefCounsel
Patricia S. Schwartz, ChiefClerk/Administrator
Vivian A. Tessieri, Legislative Clerk
Robert E. Palmer, Democratic StaffDirector
Subcommittee on Energy and Environment
KEN CALVERT, California, Chairman
HARRIS W. FAWELL, Illinois TIM ROEMER, Indiana
CURT WELDON, Pennsylvania PAUL McHALE, Pennsylvania
DANA ROHRABACHER, California MICHAEL F. DOYLE, Pennsylvania
STEVEN H. SCHIFF, New Mexico DARLENE HOOLEY, Oregon
VERNON J. EHLERS, Michigan RALPH M. HALL, Texas
MATT SALMON, Arizona EDDIE BERNICE JOHNSON, Texas
MARK ADAM FOLEY, Florida ZOE LOFGREN, California
PHIL ENGLISH, Pennsylvania ALCEE L. HASTINGS, Florida
TOM A. COBURN, Oklahoma
*RankingMinorityMember
**ViceChairman
(II)
CONTENTS
June 17, 1998—The Human Genome Project: How Private Sector De- Page
velopmentsAffect the GovernmentProgram
Opening Statement by Representative Ken Calvert (CA-43), Chairman, Sub-
committee on Energy and Environment, Committee on Science, U.S. House
ofRepresentatives 1
Opening Statement by Representative Tim Roemer (IN-3), Ranking Minority
Member, Subcommittee on Energy and Environment, Committee on
Science, U.S. House ofRepresentatives 2
Panel:
Dr. Aristides A. Patrinos, Associate Director of Energy Research for
Biological and Environmental Research, U.S. Department of En-
ergy, Washington, DC:
Oral Testimony 5
Prepared Testimony 8
Biography 14
Dr. Francis S. Collins, Director, National Human Genome Research
Institute, National Institutes of Health, U.S. Department of Health
and Human Services, Bethesda, MD:
Oral Testimony 15
Prepared Testimony 18
Biography 25
Dr. J. Craig Venter, President and Director, The Institute for
Grenomic Research, Rockville, MD:
Oral Testimony 26
Prepared Testimony 28
Biography 36
Financial Disclosure 37
DrC.hirDoasvciidencJe.R&GaDlaIsn,c.,PBrotehseildle,nWtA:and Chief Scientific Officer,
Oral Testimony 42
Prepared Testimony 46
Biography 53
Financial Disclosure 54
Dr. Maynard V. Olson, Professor of Medical Genetics and Genetics,
Department of Molecular Biotechnology, and Director, Genome
Center, University ofWashington, 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
RefocusingofFederal Human Genome Project 73
Federal Program's Use ofLatest Technologies 74
Federal Budget for the Human Genome Project 74
Dr. Olson's Criticisms ofPrivate-SectorVenture 75
Ethical, Legal and Social Concerns 77
Patentability ofHuman 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 ofIntellectual Property/Patient/Privacy Rights 83
Consequences of Private-Sector Venture for Federal Human Genome
Project 84
Efficiency ofFederal Human Genome Project 84
Appendix 1: Answers to Post-Hearing Questions Submitted by Members
of the Subcommittee on Energy and Environment
Dr. Aristides A. Patrinos, Associate Director of Energy Research for
Biological and Environmental Research, U.S. Department of En-
ergy:
Republican Member Questions:
Scientific Justification for Completing Government-Funded Sequencing
ofEntire Human Genome 87
Efficiencies ofDOE's Joint Genome Initiative vs. Three Different DOE
Laboratory Programs 88
Democratic Member Questions:
Difference Between the DOE-NIH and "Shotgun" Human DNA Se-
quencingApproaches 89
Role ofDOE and NIH in Collaboration with Private-SectorVenture 89
Concerns of International Collaborators About Intellectual Property
Rights and Patenting 90
Dr. Francis S. Collins, Director, National Human Genome Research
Institute, National Institutes of Health, U.S. Department of Health
and Human Services:
Republican MemberQuestion:
Scientific Justification for Completing Government-Funded Sequencing
ofEntire Human Genome 92
Democratic Member Questions:
Difference Between the DOE-NIH and "Shotgun" Human DNA Se-
quencingApproaches 93
Role ofDOE and NIH in Collaboration with Private-SectorVenture 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. J. Craig Venter, President and Director, The Institute for
Genomic Research:
Republican Member Questions:
Will the Private Initiative Duplicate the Federal Human Genome
Project? 97
ConcernAbout Release ofData to the Public 98
Recommendations for Restructuring the Federal Human Genome
Project 98
Democratic MemberQuestions:
Availability ofGenomic Information to the Scientific Community 99
Timeliness ofRelease ofand Compensation for Human DNA Sequence
Data 99
Plans to Patent Genomic Sequences 100
Uniqueness ofExpressed Sequence Tags 100
Role ofDOE and NIH in Collaboration with Private-SectorVenture 101
Restrictions on Researchers' Ability to Obtain Human DNA Sequence
Information 101
(IV)
Page
Relation of New Venture to the Federally-Funded Human Genome
SequencingEffort 102
Dr. David J. Galas, President and Chief Scientific Officer,
R&D
Chiroscience Inc:
Member
Republican Questions:
Practical Value of Federal Completion of Entire Human Genome Se-
quencingProcess 103
Democratic MemberQuestions:
Impacton CurrentEfforts 104
Importance ofGenomic Data That May BeWithheld 104
Reasonable Fees and Conditions to Private-Controlled Genetic Informa-
tion 104
Rights ofIndividuals' Privacy and Compensation Issues 105
Dr. Maynard V. Olson, Professor of Medical Grenetics and Genetics,
Department of Molecular Biotechnology, and Director, Genome
Center, University ofWashington:
Democratic Member Questions:
Concerns AboutAbility toAccess Genomic Information 106
Impact on CurrentEfforts 107
Importance ofGenomic Data That May Be Withheld 107
Reasonable Fees and Conditions to Private-Controlled Genetic Informa-
tion 107
Rights ofIndividuals' Privacy and Compensation Issues 108
Appendix 2: Additional Materials for the Record
J. Craig Venter, et al., "Shotgun Sequencing ofthe 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. Al 113
Bill Richards, "Perkin-Elmer Jumps Into Race to Decode Genes," The Wall
StreetJournal, May 11, 1998, p. B6 115
Nicholas Wade, "Beyond Sequencing ofHuman DNA," The New York Times,
May 12, 1998, p. C3 116
Justin Gillis and Rick Weiss, "Private Firm Aims to Beat Government in
Gene Plan," The Washington Post, May 12, 1998, p. Al 118
Clive Cookson, "Genetic mapping triggers contest: Academics race private
enterprise," TheNew York Times, May 12, 1998, p. 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. A20 121
William A. Haseltine, "Gene-Mapping, Without Tax Money," The New York
Times, May 21, 1998, p. A37 123
John Carey, "The Duo Jolting the Gene Business: Craig Venter and Perkin-
Elmer target the human genome," Business Week, May 25, 1998, pp. 70-
71 124
Steven E. Koonin, "An Independent Perspective on the Human Genome
Project,"Science 279, 36 (January 2, 1998) 126
HubmyatnheGHeunommaenPGreongormaem RMeapnoartg,emPeanrtt 1I,nfOovremravtiieown SaynsdtePmr,ogrOeasks,RiPdrgeepaNrae-d
tional Laboratory for the U.S. Department of Energy, Office of Energy
Research, Office ofBiological and Environmental Research, DOE/ER-0713
(Part 1), November 1997 128
Human Genome Program Report, Part 2, 1996 Research Abstracts, Prepared
by the Human Genome Management Information System, Oak Ridge Na-
tional Laboratory for the U.S. Department of Energy, Office of Energy
Research, Office of Biological and Environmental Research, DOE/ER-0713
(Part 2), November 1997 240
(V)
Page
William A. Haseltine, "Discovering Genes for New Medicines," Scientific
American 276,No. 3, March 1997, pp. 2-7 338
To Know Ourselves: The U.S. Department ofEnergy and the Human Genome
Project, Prepared by the Lawrence Berkeley National Laboratory for the
U.S. 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.S. 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.S. Department of Energy, Office ofEnergy Research,
Office ofHealth 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.
The Subcommittee met, pursuant to notice, at 1:05 p.m., in room
2318, Rayburn House Office Building, Hon. Ken Calvert, Chairman
ofthe Subcommittee, presiding.
Chairman Calvert. This hearing of the Energy and Environ-
ment Subcommittee will come to order.
Today we will review a program whose success will have pro-
found importance for medical science for the 21st Century. Some of
our witnesses today have used some strong language in describing
the value ofthe human genome project, but it's hard to exaggerate
the importance of a program that could lead to prevention, and
even cures, to some ofthe most serious diseases that afflict us. The
sequencing ofthe human genome began in the mid-1980's as an ef-
fort by the Department of Energy (DOE) to study the effects of ra-
diation on the survivors of Hiroshima and Nagasaki. However, it
became an international program with much broader implications
and our federal program is jointly run by DOE and the National
Institutes of Health. As the 15-year, $3 billion federal program
reached its halfway point this year, the scientific world was
stunned on May 9th when one ofthe country's foremost genetic sci-
entists. Dr. Craig Venter, and the Perkin-Elmer Corporation an-
nounced they would form a new venture to, as they put it, "sub-
stantially complete the sequencing of the human genome" in 3
years at one-tenth the cost ofthe federal program.
Just how this should affect the government program is the focus
of this hearing today. Press reports and some back and forth be-
tween critics and supporters of the federal program have raised as
many questions as it has produced answers. For example, are the
goals ofthe initiative realistic orjust an optimistic vision? Will this
private sector initiative duplicate the federal program and make it
redundgmt or is it another approach that can complement the fed-
eral program and make it stronger? Is the pace and the cost of the
federal program increased by the bureaucratic nature of any fed-
eral program or does the timetable and cost reflect what is nec-
essary to do a thorough job? And will the federal program utilize
(1)
the latest technology described in the private sector announce-
ment?
Our witnesses today, a cross-section of distinguished scientists
from the government and from the private sectors, should be able
to supply, I hope, some ofthe answers to those questions.
One of the witnesses today warns that Congress is the wrong
forum in which to debate the relative merits of different scientific
approaches to sequencing the human genome. Let me say I couldn't
agree more. We're not, as my friend Greorge Brown might say, set
up to be a science court.
However, we are given the responsibility of overseeing a federal
program that has spent about $1.9 billion to date. The—purpose of
this hearing is to get the best advice possible on how to how addi-
tional moneys should be spent.
I would also like to take a moment to thank our witnesses for
being here today. Some ofyou traveled long distances at your own
expense; others had to rearrange their personal schedules to fit
ours, and we certainly appreciate it.
Before I introduce our panel, let me turn to my good friend from
Indiana, the distinguished Ranking Minority Member, Mr. Roemer,
for his opening remarks.
Mr. Roemer. I thank our distinguished Chairman and want to
applaud him and salute him for this timely hearing on such a com-
plicated, yet fascinating, subject. I would ask unanimous consent
that my entire statement be entered into the record, Mr. Chair-
man.
Chairman Calvert. Without objection, so ordered.
Mr. Roemer. And I willjust talk for a few seconds and then yield
back the balance of my time to this expert panel. Certainly we
have heard the mantra in this Congress of faster, cheaper, better.
We have heard promises at times from the public sector, and prom-
ises at times from the private sector, that appeared too good to be
true. Here we have the possibility, a golden possibility, ofa private-
psucbileinccepaanrdtnienrsphhiepnotmheantalcorueltdurrnesfourltthientapxhpeanyeorm.enWael wraentturtno sfeoer
ifthese promises, and ifthis potential, is in fact true and if, in fact,
we can do this partnership between the public and private sector
that some have talked about. We want to look at the question of
privacy and patent issues. We want to look at many other serious
questions when it results in cutting the costs as has been talked
about in the press by such a significant degree, yet yielding the
science that we have been talking about for the last decade. So I'm
anxious to hear from our expert witnesses. I'm very, very inter-
ested in this topic and we look forward to our expert panel giving
us the insight and the advice to fulfill the mantra of faster, cheap-
er, better, not just with political rhetoric but with real promise for
a private sector, public sector partnership. And with that, I yield
back the balance ofmy time.
[The prepared statement ofMr. Roemer follows:]