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Joshua Gottheimer's Files
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Joshua Gottheimer
Office of Speechwriting OEOB 196
#6
1. Background for Morgan State
2. Consumer Fraud
3. MIT Speech Briefing Binder
4. CFR Binder
5. SOTU HHS
Background Material For
Morgan State Speech
Background Material
Morgan State speech
Jack Gibbons
Assistant to the President
For Science and Technology
456-7116 (o)
540/353-5409
OSTP/Jeff Smith (6-6047)
Science in the National Interest
OSTP S&T Report
Progress in Health
Progress in Agriculture
NBAC
Building Public Trust
Glenn Bill (S.193)
Human Subject Abuse
Varmus - Human Subject Protection
Satcher - Human Subject Protection
Tuskegee Legacy Report
Gulf War
Scientific Freedom
S&T and Economy
Returns to R&D
Supporting R&D
Technology in the National Interest
Clinton Presidential Records
Digital Records Marker
This is not a presidential record. This is used as an administrative
marker by the William J. Clinton Presidential Library Staff.
This marker identifies the place of a tabbed divider. Given our
digitization capabilities, we are sometimes unable to adequately
scan such dividers. The title from the original document is
indicated below.
5/8 memo
Divider Title:
5/8 memo
OSTP
DRAFT 5/8/97
Possible Approach for Morgan State
I)
Our commitment to science and technology
Reiterate strategy of fiscal responsibility, streamlining government while at the same time
protecting investments in education and research. The enduring Federal commitment to
science, to technology, to learning, to research is the key to our future, essential to our
economy, health, environment, security. Our strategy is working. It's gratifying that
Congress is moving with us.
The pace of science, and the resulting technological advances, is accelerating so rapidly
that textbooks are frequently obsolete before they're printed. Humankind places a
tremendous premium on (a) an increasingly sophisticated base of skilled human resources
and knowledge, (b) a well-functioning and resilient natural resource system. As
populations grow and economic activities expand, our hopes for sustained progress --
sustainable development hinge on human ingenuity.
With global linkages growing stronger, the rapid movement of people, goods,
information has permanently altered commerce, national security, demographics and
health. The cost of "natural" disasters that can be greatly lessened through S&T now
amounts for the U.S. alone to about $1 billion per week; how the potential of enormous
impacts of global climate change can be lessened with timely action; the opportunity to
capitalize on the revolutions in biology and biomedicine to improve human health,
agriculture, etc.]
II) Health and Disease
Evidence abounds of the returns from scientific research and potential for the future.
Today's doctors treat symptoms. The human body and its ailments are so complex that it
may be that we are better at diagnosing and curing what is wrong with our cars than with
ourselves. We need to give our doctors a toolbox as good as a mechanic's.
Tomorrow's doctors will have the tools to predict and prevent. Understanding the chain
of events that cause disease offers real insight into what can be done to cure it, or
preferably, prevent it from occurring in the first place. There is growing optimism
regarding new drugs to treat AIDS or a vaccine to prevent its spread. Chronic,
debilitating diseases such as diabetes, high blood pressure, arthritis and sickle cell anemia
may succumb to innovative new therapies.
III) Ethics
Our ethics must be as good as our science.
In American tradition, freedom of scientific inquiry is likened to freedom of speech and
holds very great respect. There is a practical dimension to this attitude in that allowing
scientific opportunity to guide research directions has proven benefits (examples of
unpredicted payoffs and those in unrelated fields).
Knowledge, in and of itself, is value-neutral; but knowledge may be used for good or evil.
The very success of science and the technology that emerges from it is a distinct form of
power that must be nurtured and governed with a watchful eye.
We acknowledge the need for societal governance of the use of science and technology,
but we also acknowledge the imperative that such governance be thoughtful and careful,
that liberty and privacy (respect for persons, beneficence and justice), for example, be
protected. It is a complex line. Our choices carry great weight. That is why federal
oversight is necessary in some cases to ensure that societal values, informed by
cultural/religious views, are not trumped, while at the same time continuing our tradition
of freedom of scientific inquiry. It is for this reason that the President created NBAC.
Accounts of past abuses of the human subjects of research (Tuskegee, radiation) and the
desire to prevent abuse from ever occurring again, along with the increasing power of
technology to work with the forces of nature, joined to form an imperative need for
continuing thoughtful prospective governance of our Nation's biomedical and behavioral
research enterprise.
IV) Policy
Extension of NBAC charter
Diabetes initiative
Long-term goal for R&D support. Strengthening our S&T investments will reap ample
rewards. We must all be the constituency of the future.
Others
The gulf between the cultures of science and politics. Their different time perspectives.
Ozone depletion, global warming, loss of biodiversity have long time constants. While it
may take two decades for Nobel recognition or five decades for climate change, political
change often comes about in hours or days.
We are in the formative stages of coupling the physical, biological and social sciences in
the pursuit of global knowledge. C.P. Snow's admonition that we must bridge the gap
between our cultures of natural science and social science if we are to effectively tackle
the research challenges and opportunities ahead. The challenge is to build those bridges
not only to the next century, but across the cultural divides that we must not allow to
separate us.
What we need from a writing
perspective:
Science/esp. life sciences- - what their
importance will be
Ethics issues -
religious perspective
- problem areas in the part
e.g., Tuskegee.
-good gs. of "scare headliner."
Research + the importance of basic research.
minority science issues.
What we need here are journal articles,
books, speeches, reports, fact sheets, etc.
This does not
really policy refor to the
initiatives.
FACTS & ANECDOTES need: 5/8
CHECKLIST
from Machod
Woldenan
increased importance of science (statistics & ancedates,
this past mestering century and facture.
specific examp les of progress were made in recent
Z
years, esp. on medicine and health.
3
specific predictions /supportions re: future (new technologies,
cures, breakthroughs)
fin h 1H cleater Golder
Brocthics - Garenance to I rescordi
examples of misure in past-Tushegee, - radiation
are ones we know- - others? NBAC.
economy R.g., high tech indentries that are
increasing importance of science & tech to our
(Steeplitz)
now leading in world competition, #of jobo.
AIRS
(CEA-Lyn)
6
ALSO... speeches/essays by. Gibbons, Gone, Varmus, Satcher
(Reotes.)
7
gleen
other Presidents (e.g., Eisenhower, postSputmik
Kennely)
waterfacom
religiousfigues-Pope?
7
Freeden of Scentfir lugury
Clinton Presidential Records
Digital Records Marker
This is not a presidential record. This is used as an administrative
marker by the William J. Clinton Presidential Library Staff.
This marker identifies the place of a tabbed divider. Given our
digitization capabilities, we are sometimes unable to adequately
scan such dividers. The title from the original document is
indicated below.
Science in the
National Interest
Divider Title:
Clinton Presidential Records
Digital Records Marker
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This marker identifies the place of a publication.
Publications have not been scanned in their entirety for the purpose
of digitization. To see the full publication please search online or
visit the Clinton Presidential Library's Research Room.
.
Science in the National Interest
OF
MISIDENT OFTHE SEAL UNUM SEXTS THE UNITED THE UNITED
President William J. Clinton
Vice President Albert Gore, Jr.
Clinton Presidential Records
Digital Records Marker
This is not a presidential record. This is used as an administrative
marker by the William J. Clinton Presidential Library Staff.
This marker identifies the place of a tabbed divider. Given our
digitization capabilities, we are sometimes unable to adequately
scan such dividers. The title from the original document is
indicated below.
OSTP S & T Report
Divider Title:
THE WHITE HOUSE
WASHINGTON
To The Congress of the United States:
A passion for discovery and a sense of adventure have always driven
this Nation forward. These deeply rooted American qualities spur our
determination to explore new scientific frontiers and spark our can-do spirit
of technological innovation. Continued American leadership depends on our
enduring commitment to science, to technology, to learning, to research.
Science and technology are transforming our world, providing an age of
possibility and a time of change as profound as we have seen in a century. We
are well-prepared to shape this change and seize the opportunities SO as to
enable every American to make the most of their God-given promise. One
of the most important ways to realize this vision is through thoughtful
investments in science and technology. Such investments drive economic
growth, generate new knowledge, create new jobs, build new industries,
ensure our national security, protect the environment, and improve the
health and quality of life of our people.
This biennial report to the Congress brings together numerous elements
of our integrated investment agenda to promote scientific research, catalyze
technological innovation, sustain a sound business environment for research
and development, strengthen national security, build global stability, and
advance educational quality and equality from grade school to graduate
school. Many achievements are presented in the report, together with
scientific and technological opportunities deserving greater emphasis in
the coming years.
Most of the Federal research and education investment portfolio enjoyed
bipartisan support during my first Administration. With the start of a new
Administration, I hope to extend this partnership with the Congress across
the entire science and technology portfolio. Such a partnership to stimulate
scientific discovery and new technologies will take America into the new
century well-equipped for the challenges and opportunities that lie ahead.
The future, it is often said, has no constituency. But the truth is, we must
all be the constituency of the future. We have a duty - to ourselves, to our
children, to future generations - - to make these farsighted investments in
science and technology to help us master this moment of change and to build a
better America for the twenty-first century.
William 1. Cinton
Chapter 1
CIENCE: THE ENDLESS RESOURCE
Underpinning Our Nation's Economic Well-Being,
Health, and National Security
"Cutting back on research at the dawn of a new century where research
is more important than it has been for even the last fifty years would
be like cutting our defense budget at the height of the Cold War."
unpredictability
-President Bill Clinton
hroughout time, humans have pondered the
basic research on the way liquids pass through holes
nature of the universe and the laws that order it,
would lead to improved fuel injection systems for
seeking to understand our world and our place in
cars, ink-jet printers, and artificial heart valves;
the cosmos. Curiosity and the quest for understanding
basic studies of the attitudes and behaviors of tens
punctuate all human growth and learning, beginning
of millions of military personnel over decades would
with our childhood questions: "What is it?" "How does
lay the foundation for many of today's high-perfor-
it work?" "What happens if
?" Basic (or fundamen-
mance business management practices;
tal) research seeks to answer these and other questions
in all scientific fields. Basic research usually does not
engineering experiments on microelectromechanical
have a specific practical benefit in mind; it simply
systems would create a billion-dollar industry pro-
helps us understand the way things are and generates
viding acceleration sensors for automobile air bags,
new ideas and questions about the unknown. It has
and many other products;
taught us about the evolution of the physical universe,
fundamental research on magnetism would trans-
the evolution of life, and a wealth of other topics.
form our society, making our information age possi-
Inevitably, however, the results of basic research
ble through tape recorders, video cassette recorders,
are prerequisites for many advances that substantially
and everything else that records and stores informa-
improve our lives. No one could anticipate that:
tion; or
early studies of the DNA molecule would lead to
decades of research in basic physics and chemistry
genetic engineering to develop new and effective
would provide the sophisticated tools essential for
drugs, more productive crops, and more nutritious
molecular biology, genome sequencing, and advanced
foods;
medical diagnosis and treatment.
ultra-precise atomic clocks invented to test the laws
Although it is virtually impossible to predict specifi-
of physics would become the heart of the Global
cally how today's basic research results will eventually
Positioning System - now a multi-billion-dollar
improve our quality of life, or to imagine the new
business used for navigation, emergency rescue,
industries and markets that will emerge, there is no
racking commercial vehicles, and perhaps soon for
question that such improvements and industries will
air traffic control;
arise. America's scientists and engineers are working
Science and Technology Shaping the Twenty-First Century 11
Technologies/Industries Derived from Fundamental Science
SUBSTANCE
EXAMPLE
SCIENCE
TECHNOLOGIES/INDUSTRIES
MATERIALS SCIENCE
MATERIAL
CRUDE OIL
TRANSPORTATION, CONSTRUCTION:
MANUFACTURING, MEDICINE
CHEMISTRY
CHEMICALS/PHARMACOLOGY
MOLECULE
BENZENE
ATOMIC PHYSICS
LASERS, TRANSISTORS, COMPUTERS
ATOM
CARBON
CARBON
NUCLEAR PHYSICS
NUCLEAR POWER, MRI, NUCLEAR
NUCLEUS
NUCLEUS
MEDICINE
support Basis you admin
NS/
ONS
QUARK PHYSICS
UNKNOWN
HIGH-ENERGY PHYSICS UNKNOWN
Basic science studies matter at all levels of aggregation, from the materials we experience everyday down to their most
fundamental constituents. This progress leads to new scientific and technical knowledge and, years later, to innovative products
and lucrative commercial markets. These advances have generated millions of high-skilled, high-wage jobs and significantly
improved the quality of life for Americans.
in universities, industrial laboratories, research insti-
OUR NATIONAL GOALS FOR SCIENCE
tutes, and national laboratories on important research.
Their results will transform our lives in the twenty-first
To advance America's interests in science, mathemat-
century, just as we now reap the harvest from past discov-
ics, and engineering, the Administration set forth the
eries. Our children and grandchildren will look back with
following goals in its 1994 science policy statement,
the same wonder we experience today at the myriad ways
Science in the National Interest:
frontier basie has advanced society.
To sustain leadership across the frontiers of scien-
The Administration's commitment to basic research
tific knowledge.
derives from a clear and positive vision for the future
prosperity of our nation and a strong belief that by creat-
To enhance connections between fundamental
ing knowledge and a well-educated citizenry, we gain the
research and broad national goals.
power to shape our future. Therefore, the Administration
To stimulate partnerships that promote invest-
has championed Federal investments in science and tech-
ments in fundamental science and engineering and
nology, stressing repeatedly that science fuels technol-
effective use of physical, human, and financial
ogy's engine - the engine of economic growth that cre-
resources.
ates jobs, builds new industries, and improves our stan-
dard of living. Moreover, a significant component of Fed-
To produce the finest scientists and engineers for
erally sponsored research is performed in colleges and
the twenty-first century.
universities, where young scientists and engineers are
To raise the scientific and technological literacy of
trained in the process of creating new knowledge.
all Americans.
12 Science and Technology Shaping the Twenty-First Century
nieving these goals will ensure that our nation
the dominant sponsor of the nation's long-term, basic
has the specialized human resources as well as the
research portfolio. The Administration has embraced
modern infrastructure needed for cutting-edge science
this role by continuing to support the basic science pro-
and technology. The science and technology enterprise
grams of the National Institutes of Health (NIH) in the
weaves a vast and variegated fabric of knowledge,
Department of Health and Human Services (HHS), the
ideas, devices, and questions that covers a broad range
National Science Foundation (NSF), the Department of
of human curiosity and innovation.
Energy (DOE), and the National Aeronautics and Space
This report is organized around these science policy
Administration. These programs are vital to our nation's
goals, and this chapter focuses on leadership in the gen-
future, as are those at the Department of Defense
eration of fundamental knowledge that defines basic
(DOD), and the Departments of Agriculture (USDA),
science. The chapters on technology, health, environ-
Commerce (DOC), Interior (DOI), and other Federal
ment, and national security capture the partnerships
agencies with targeted missions. Between FY 1993 and
and connections that harness new knowledge, helping
the Administration's FY1998 budget request, Federal
us reach those overarching national goals. The chapter
investment in basic research has risen from $13.36 bil-
on human resources addresses the production of the
lion to $15.30 billion - an increase of 14.5 percent.
world's best scientists and engineers, and the need to
This diversity of Federal sources of research funding
improve public literacy in science and technology.
and the rich variety of institutions and organizations
conducting the research are two of the strengths con-
tributing to U.S. leadership across the scientific fron-
SUSTAINING LEADERSHIP ACROSS THE
tiers. Universities and colleges - where education pro-
FRONTIERS OF SCIENTIFIC KNOWLEDGE
ceeds synergistically with the creation of new knowl-
edge - consistently perform about one-sixth of all
Leadership across the frontiers of scientific knowledge
Federally funded R&D, and over half of our basic
is not merely a cultural tradition of our nation - today
research. Federal laboratories, nonprofit research
an economic and security imperative. Creative
institutes, and industrial firms are also major players.
: working in diverse fields generate new knowl-
The laboratories of DOE, NIH, NASA, and USDA, par-
- rich in wonder and often leading to unexpected
ticularly, are deeply integrated into America's funda-
applications. The range of our research spans all major
mental science enterprise in their mission areas. Rich
fields of science and engineering and is one of its most
in human talent and engineering capability, these Fed-
powerful attributes.
eral laboratories are renowned for unique, state-of-the-
There is a solid consensus that maintaining the
art scientific facilities, instruments, and other
human resources and modern infrastructure essential
resources, operated for and made available to the
for scientific leadership is a fundamental Federal
national scientific community. Of course, a major com-
responsibility. Thus, public funding of research and
ponent of the R&D portfolios of these laboratories, as
development traditionally has enjoyed strong, biparti-
well as those of DOD, DOC, and other agencies, serves
san support. Government investments provide world-
their overriding missions to ensure national security,
class facilities, promote scientific breakthroughs and
and to promote technological progress, health, envi-
interdisciplinary linkages among the major science and
ronmental quality, and food supply as described in the
engineering fields, and train talented people to tackle
other chapters of this report.
emerging scientific challenges. As corporate R&D labo-
Most important, the people actively engaged in the
ratories have increasingly favored applied research and
quest to understand the unknown power our innova-
development projects likely to improve competitiveness
tion system. They recognize, pursue, and exploit break-
in the near term, the Federal government has become
throughs, no matter where in the world they are made.
America's Best: Our 1993-1996 Nobel Prize Winners
In each of the last four years, American scientists funded by the U.S. government have won Nobel prizes.
These awards reflect the enormous dividends of specific research investments included years ago in our
national research and development portfolio by the National Science Foundation, the National Institutes of
fealth, the Department of Energy, and the Department of Defense.
Science and Technology Shaping the Twenty-First Century 13
Nobels
Nobel Prize Winners 1993-1996
1993
NOBEL PRIZE IN PHYSICS awarded jointly to:
Russell A. Hulse, Princeton University, Princeton, NJ, and
Joseph H. Taylor, Jr., Princeton University, Princeton, NJ,
for the discovery of a new type of pulsar, a discovery that has opened up new possibilities for the study
of gravitation
NOBEL PRIZE IN CHEMISTRY awarded for contributions to the developments of methods within
DNA-based chemistry with one-half to:
Kary B. Mullis, La Jolla, CA, for his invention of the polymerase chain.reaction (PCR) method
and one-half to:
Michael Smith, University of British Columbia, Vancouver, Canada, for his fundamental contribu
tions to the establishment of oligonucleiotide-based, site directed mutagenesis and its development for
protein-studies.
NOBEL PRIZE IN PHYSIOLOGY OR MEDICINE awarded jointly to:
Richard J. Roberts, (U.K.), New England Biolabs, Beverly, MA, and
Phillip A. Sharp, Massachusetts Institute of Technology, Cambridge, MA,
for their discoveries of split genes.
BANK OF SWEDEN PRIZE IN ECONOMIC SCIENCES IN MEMORY OF ALFRED NOBEL
awardedijointly to:
Robert W. Fogel, University of Chicago, Chicago, IL, and
Douglass C. North, Washington University, St. Louis, MO,
for having renewed research in economic history by applying economic theory and quantitative meth-
ods in order to explain economic and institutional change.
1994
NOBEL PRIZE IN PHYSICS awarded for pioneering contributions to the development of neutron scat
tering techniques for studies of condensed matter with one-half to:
Bertram N. Brockhouse, McMaster University, Ontario, Canada, for development of neutron spectroscopy
and one-half to:
Clifford&G Shull, Massachusetts Institute of Technology, Cambridge, MA, for the development of
the neutron diffraction technique.
NOBEL PRIZE IN CHEMISTRY awarded to:
George A. Olah, University of Southern California,
for his contribution to carbocation chemistry.
NOBEL PRIZE IN PHYSIOLOGY OR MEDICINE awarded jointly to:
Alfred G. Gilman, University of Texas Southwest Medical Center, Dallas, TX, and
Martin Rodbell, National Institute of Environmental Health Sciences, Research Triangle Park, NC,
for their discovery of G-proteins and the role of these proteins in signal transduction in cells.
BANK OF SWEDEN PRIZE IN ECONOMIC SCIENCES IN MEMORY OF ALFRED NOBEL
awardedjointly to:
John C. Harsanyi, University of California-Berkeley, Berkeley, CA,
John F. Nash, Princeton University, Princeton, NJ, and
Reinhard Selten, Rheinische Friedrich Wilhelms Universität, Bonn, Germany,
for their pioneering analysis of equilibria in the theory of non-cooperative games.
14 Science and Technology Shaping the Twenty-First Century
1995
NOBEL PRIZE IN PHYSICS awarded for pioneering experimental contributions to lepton physics
with one-half to:
Martin L. Perl, Stanford University, Stanford, CA, for the discovery of the tau lepton,
and one-half to:
Frederick Reines, University of California-Irvine, Irvine, CA, for the detection of the neutrino.
NOBEL PRIZE IN CHEMISTRY awarded jointly to:
Paul J. Crutzen (Netherlands), Max Planck Institute for Chemistry, Mainz, Germany,
Mario J. Molina, Massachusetts Institute of Technology, Cambridge, MA, and
Sherwood F. Rowland, University of California-Irvine, Irvine, CA, for their work in atmospheric
chemistry, particularly concerning the formation and decomposition of ozone.
NOBEL PRIZE IN PHYSIOLOGY OR MEDICINE awarded jointly to:
Edward B. Lewis, California Institute of Technology, Pasadena, CA,
Christiane Nüsslein-Volhard, Max Planck Institut für Entwicklungsbiologie, Germany, and
Eric F. Wieschaus, Princeton University, Princeton, NJ, for their discoveries concerning the genetic
control of early embryonic development.
BANK OF SWEDEN PRIZE IN ECONOMIC SCIENCES IN MEMORY OF ALFRED NOBEL
awarded to:
Robert E. Lucas, Jr., University of Chicago, Chicago, IL, for having developed and applied the
hypothesis of rational expectations, and thereby having transformed macroeconomic analysis and
deepened our understanding of economic policy.
1996
NOBEL PRIZE IN PHYSICS awarded jointly to:
David M. Lee, Cornell University, Ithaca, NY,
Robert C. Richardson, Cornell University, Ithaca, NY, and
Douglas D. Osheroff, Stanford University, Stanford, CA, for discovery of superfluidity in helium-3.
NOBEL PRIZE IN CHEMISTRY awarded jointly to:
Robert F. Curl, Jr., Rice University, Dallas, TX,
Richard E. Smalley, Rice University, Dallas, TX, and
Sir Harold W. Kroto, University of Sussex, Brighton, U.K., for their discovery of fullerenes.
NOBEL PRIZE IN PHYSIOLOGY OR MEDICINE awarded jointly to:
Peter C. Doherty (Australia), St. Jude's Hospital Memphis TN, and
Rolf M. Zinkernagel, University of Zürich, Switzerland, for their discoveries concerning the speci-
ficity of the cell mediated immune defense.
BANK OF SWEDEN PRIZE IN ECONOMIC SCIENCES IN MEMORY OF ALFRED NOBEL
awarded to:
James A. Mirrlees, University of Cambridge, U.K., and
William Vickrey, Columbia University, New York, NY, for their fundamental contributions to the
economic theory of incentives under asymmetric information.
Science and Technology Shaping the Twenty-First Century 15
For example, in the mid-1980s
European scientists discovered
high-temperature supercon-
ductors. Immediately, Ameri-
can investigators with the req-
uisite expertise turned their
energies with great success to
extending and exploiting this
discovery, both in terms of fun-
damental understanding and
engineered applications.
Given the growing linkages
among the scientific and tech-
nical disciplines, it is impossi-
ble to predict what expertise
will be indispensable for
future developments. As with
any investment portfolio, cer-
tain areas will be emphasized
at any given time because of
special opportunities for
progress and impact. The Fed-
eral portfolio, however, must
remain broad-based and
accommodate the high-risk
investments that may have
enormous long-term impact.
It is increasingly evident that
the major fields of science and
engineering mutually catalyze
one another - strengthening
the fabric of science and, with
it, the entire science and tech-
nology enterprise. By advanc-
Scientific breakthroughs spur new technologies that, in turn, enable improved scien-
ing all frontiers of knowledge,
tific capabilities to explore the unknown. It was not until the mid-1980s that physics under-
creative American scientists
standing, niobium purity, and ultraclean manufacturing and processing techniques made it
feasible to build a superconducting electron accelerator needed to explore the innermost
and engineers, along with
structure of the atom's nucleus. The world's largest assembly of superconducting accelerator
their students, enrich the pre-
cavities is now at the Department of Energy's Thomas Jefferson National Accelerator Facil-
sent and shape the future.
ity in Newport News, Virginia.
BASIC RESEARCH FUNDING BY AGENCY
BASIC RESEARCH PERFORMERS
FEDERAL BASIC RESEARCH PORTFOLIO
FY 1998 Budget Request $15.3 Billion
FY 1995 $14.2 Billion
FY 1995 $14.2 Billion
NSF
Federal Laboratories
Biological &
Medical Sciences
Engineering.
DOE
Computer Solence
& Mathematics
Other
NIH
Other
Industry
Social & Behavioral
NASA
Sciences
Universities
Environmental
Non-Profits
& Colleges
Sciences
Physical Sciences
DOD
Source: NSF Science and
Source: NSF Science and
USDA
Source: OMB
Others
Engineering Indicators, 1996
Engineering Indicators, 1996
16 Science and Technology Shaping the Twenty-First Century
eries that inspire our
children and society
GERMANY
at large. This ability
to uncover and
understand nature's
secrets is a uniquely
UNITED STATES
human accomplish-
ment. Only the Fed-
eral government can
UNITED KINGDOM
supply the truly
"patient capital" for
FRANCE
the long-term invest-
CANADA
ment in basic
ITALY
research.
The human infra-
structure - creative
scientists and engi-
neers, trained at the
research frontier and
able to move boldly in
response to new
opportunities and
challenges - posi-
tions America at the
forefront of the
nondefense R&D/GDP ratios of both Japan (2.7 percent) and Germany (2.4 percent) consid-
"brainpower indus-
erably exceeded that of the United States (2.0 percent) in 1993 and have done so for years. The non-
tries" of the future.
defense R&D ratio of France matched the ratio of the United States; the ratios of the United King-
Such industries -
dom (1.9 percent), Canada (1.5 percent), and Italy (1.3 percent) were somewhat lower.
high technology,
health-care technol-
In this time of constrained resources, some have
ogy and biotechnology, business technologies, multime-
argued that less emphasis should be placed on basic
dia technologies, and others - increasingly support
research, since its results are typically available to any-
expansion of our export economy. America's economic
one in the world. Japan, for example, has developed
resilience, as demonstrated in the rapid recovery of our
strong market positions for some products, particularly
leadership in semiconductors over the last five years, is
consumer electronics, for which American scientists did
clearly tied to our strength in science and technology,
much of the original research and development. The
especially the basic and applied research capacity and
Administration rejects this simplistic argument. The
human capital that spring from our research universi-
dominance of our basic research enterprise is a core
ties. Indeed, it is noteworthy that Japan's decision to
American strength that must be preserved. This enter-
dramatically increase research funding emphasizes
prise, in addition to producing new knowledge that is
strengthening its research universities.
indeed appropriable by others, generates the physical
Competitive advantages clearly accrue to nations
and human infrastructure that underlies our national
fashioning the future through investments that
innovation system and our society's resourcefulness in
return new, basic knowledge. Although our total
the face of rapid technological change.
investment in non-defense research and develop-
We also must remember that basic research repays
ment remains the highest in the world, it is only 75
society in the near term through newsworthy discov-
percent that of Japan and 85 percent of Germany's
as a fraction of Gross Domestic Product (GDP). We
must not let our position erode and thus compro-
(Left) The diversity of Federal sources of basic research
mise our future.
ding, and the variety of institutions and organizations
lucting the research contribute to U.S. leadership across
scientific frontiers spanned by the Federal scientific and
technical research portfolio.
Science and Technology Shaping the Twenty-First Century 17
Mediane
Lakthroughs with
impacts comparable to
those of the transistor,
optical fiber, and solid-
state laser. Continued
progress and innova-
tion in materials
research lies at the
heart of our scientific
and technological
future.
FROM MOLECULES
TO MEDICINE
The human genome is
the complete set of
genetic instructions
found in the nucleus of
most cells on 23 pairs
of chromosomes that
THE VISIBLE
are long strands of
HUMAN
DNA. Each gene is a
PROJECT
Images derived from the
segment of DNA that
arries the blueprints
National Library of Medicine's
Name
a specific molecule,
Visible Human Data Set
usually a protein.
When there is a mis-
"Visible Humans" have transformed the teaching and practice of medicine. A 59-year-old
take in the order of
female and a 39-year-old male donated their bodies to science, and became immortalized as the first
digitized cadavers, available to the public and the medical community over the Internet. Images
chemical bases that
obtained from computerized tomography, magnetic resonance imaging, and high-resolution pho-
comprise the DNA cod-
tographs were compiled into a database, providing complete, anatomically correct, three-dimensional
ing for a specific pro-
views. The uses of these "recyclable" bodies include rehearsal of surgery, repeated dissection, comput-
tein, that protein may
erized crash testing, and numerous other medical simulations.
be altered, missing, or
ineffective in the family members carrying the error.
genetic component. By developing and making widely
The methods for locating such disease genes include
available the tools for locating and rapidly sequencing
the construction of detailed maps to identify the posi-
genes, the Human Genome Project - an ambitious
tion of the gene on a chromosome, sequencing the DNA
international research effort - is accelerating the
in the area where the gene is localized, and comparing
progress of molecular medicine.
the gene sequence in individuals who have the disease
The Human Genome Project, funded by NIH, DOE,
with those who do not. For a newly isolated gene, the
and several international partners, is helping scien-
researcher can quickly gather from on-line databases
tists gain a genetic understanding of disease and also
everything that has already been determined about its
of healthy processes, such as growth, development,
identity, function, and protein product.
and how the immune system recognizes a foreign
Over many years, the list of human diseases that
invader. Once the genetic basis of a disease is discov-
result from known defects in a single gene has grown
ered, scientists have a better chance of defeating it.
to about 4,000. Many of these conditions are rare and
One example is prevention based on detection of a
afflict only a fairly small number of people; sickle cell
genetic predisposition to an inherited disorder such as
disease is an exception, affecting more than 50,000
colon cancer. Individuals who inherit certain muta-
individuals in the United States. However, it has also
tions on chromosomes 2 or 3 have a 70 to 80 percent
ecome clear that many complex afflictions, such as
chance of developing a particular type of colon cancer.
cardiovascular disease, diabetes, Alzheimer's disease,
They may benefit from eating a high-fiber, low-fat diet
some forms of cancer, and other diseases, have a strong
and from scheduling annual colon exams starting at
Science and Technology Shaping the Twenty-First Century 23
THE NATIONAL SCIENCE FOUNDATION'S NEW MAJOR SCIENTIFIC FACILITIES
National Nanofabrication Users Network (Nodes in California; New York; Pennsylvania; Washington,
D.C.); operational in 1994. Network providing electronic access to fabrication equipment and expertise on
nanoscale materials and devices.
Gemini Observatories (Hawaii, Chile); to be completed in 2000. New-generation 8-meter optical/infrared
telescopes with matching facilities in Northern and Southern Hemispheres.
National Radio Astronomy Observatory/Greenbank Telescope (West Virginia); to be completed in 1998
World's largest and most versatile steerable radio telescope
National Optical Astronomy Observatories (NOAO)/WIYN Telescope (Arizona); completed in 1993. Tele-
scope for optical and infrared astronomy.
NOAO/Global Oscillation Network (worldwide); completed in 1995. Network of telescopes to monitor
the Sun.
National Astronomy and Ionosphere Center (Puerto Rico); to be completed in 1997. Upgrade for planetary
astronomy and upper atmosphere studies.
National High Magnetic Field Laboratory (Florida; New Mexico); began operations in 1993. Science and
engineering research on materials.
Cornell Electron Storage Ring (New York); to be completed in 1999. Upgrade for high energy physics and
synchrotron radiation experiments.
Laser Interferometer Gravitational Wave Observatory (Louisiana and Washington); to be completed in
2001. Will study gravitational waves to test Einstein's theory of gravitation and to open a new type of astronomy.
age 30, an age considerably younger than that recom-
learning skills and interaction modes. Merely being
mended for the general population.
able to read, write, and calculate is no longer sufficient.
Another disease that can now be detected by testing
Everyone needs to master the skills required to extract
a blood specimen is cystic fibrosis, the most common
and integrate relevant information and use it for com-
lethal hereditary disease among Caucasians. The first
plex decision-making and problem-solving.
human gene therapy trials are under way in Federally
The Federal government has supported much of the
approved clinical trials. Understanding the course of
research on how humans learn, process information,
cystic fibrosis at its most elementary level already has
and then use that information to solve problems. Recent
led to the development and approval of a drug that
decades have seen dramatic advances in our under-
dramatically lessens its severity and improves the
standing of human learning, from the level of neuro-
quality of life for those suffering from it.
chemistry and brain structure to the whole person.
The ethical, legal, and social issues associated with
Neuroscientists, engineers, and computer scientists
human genome research are being addressed in paral-
have developed new tools to provide insights into how
lel with the scientific exploration and in a manner
human memory organizes different kinds of informa-
that encourages maximum public involvement. In
tion. Psychologists and linguists are characterizing cog-
addition, President Clinton established the National
nitive phenomena and mental processes ever more thor-
Bioethics Advisory Commission and charged it to con-
oughly. Artificial intelligence researchers have repli-
sider as one of its first priorities the appropriate use
cated mechanisms for learning and decision-making
and management of genetic information. Our policies
that have widespread applicability. Education
and regulations need to keep pace with knowledge
researchers have developed cognitive-based methods
that promises such great rewards in disease preven-
that significantly improve students' thinking skills
tion and cure.
through research-based teaching. Engineers and com-
puter scientists have developed intelligent systems that
LEARNING AND HUMAN POTENTIAL
can learn from their environments and operate complex
systems safely and reliably. All this progress has appli-
The current revolution in information and communica-
cations in education reforms, medicine, psychotherapy,
tions technologies is creating demands for new human
and management.
24 Science and Technology Shaping the Twenty-First Century
Health
Chapter 5
HEALTH
Improving Health Through Research for Better
Medical Care and a Safe and Abundant Food Supply
"Our strategy for continuing to improve America's health, safety, and
food emphasizes investing in the fundamental research necessary to
assure our future well-being, promoting prevention in the areas of both
health care and environmental protection, and educating Americans
so they can improve their own health and safety decisions."
- President Bill Clinton
mproving the health of our nation's citizens contin-
Protection Agency (EPA), and the Departments of
ues to be a major goal of our Federal investment in
Energy (DOE), Defense (DOD), Veterans Affairs (VA)
science and technology. Starting in 1862 with the
and Commerce, sponsor research programs that con-
financial support for our Land Grant institutions and
tribute greatly to improving the health and food secu-
State Agricultural Experiment Stations (SAESs), and
rity of all Americans.
through the establishment in 1887 of the laboratory
In addition to improved health, this Federal invest-
that became the National Institutes of Health (NIH),
ment contributes to an economically robust agriculture
the United States has developed a system of intra-
and health care industry. The production of food and
and extramural support for health-related research
fiber is the nation's largest industry, accounting for
that is the envy of the world. Clearly, Federal support
about 15 percent of Gross Domestic Product (GDP)
for biomedical and agricultural research has resulted
and approximately 16 percent of all civilian jobs in the
in enormous improvements in the overall health and
U.S. economy. Our nation's agricultural exports con-
well-being of our nation's citizens. Today, average life
tribute over $100 billion in business activity with a
expectancy of 76 years is 60 percent greater than the
positive trade balance of approximately $20 billion.
typical life expectancy of 47 years nearly a century
Likewise, health care and related activities are esti-
ago. Much of that increase is due to better food, better
mated to account for up to one trillion dollars in
sanitation, and medical advances including vaccina-
annual expenditures in the United States, with 7.4
tions to reduce or eliminate many childhood diseases.
percent of the U.S. workforce making its living in the
Federal funding for biomedical and agricultural
health care industry.
research is multifaceted. Although the primary per-
Even though our past investment strategy has been
formers are university and Federal scientists sup-
enormously successful, the economic, scientific, and
ported by the Department of Health and Human Ser-
social context for future science and technology invest-
vices (HHS) and the Department of Agriculture
ments in health has changed dramatically in the last
USDA), other Federal agencies, such as the National
decade. With these changes, it is imperative that we
Science Foundation (NSF), National Aeronautics and
reassess our Federal investments and make changes
Space Administration (NASA), the Environmental
to reflect new realities.
Science and Technology Shaping the Twenty-First Century 95
In health care, major shifts are occurring in the age
THE ADMINISTRATION'S COMMITMENT
distribution of the U.S. population. For example, in
1990, 12.5 percent of our citizens were age 65 and
TO BIOMEDICAL RESEARCH
older. In 2030 half of the baby boomers will reach
This Administration has strongly backed biomedical
65, resulting in over 20 percent of the nation falling
research investments. Since 1993, the NIH budget has
in the 65 and older age category. (U.S. Census
been increased by $2.4 billion (23 percent), represent-
Bureau projections). This will increase the preva-
ing significant new investment in biomedical research,
lence of diseases that are associated primarily with
in an era of constrained budgets. This commitment rec-
the elderly, such as some types of cancer,
ognizes the need for stability to protect our long-term
Alzheimer's disease, and osteoporosis. Shifts also
investment in the biomedical sciences. Living cultures
are occurring in how healthcare is financed, with
or animal strains must continue to be fed, patients
more and more people participating in managed
enrolled in clinical trials must be cared for, and the
care programs. We must determine the impact this
search must be continued for better methods for pre-
will have on basic and clinical research that under-
venting, diagnosing, and treating disease. The Admin-
lies future medical advances. In an attempt to keep
istration continues to sustain this critical investment
down costs of long-term care, as well as improve the
in order to reap the benefits of better health and qual-
overall quality of life, greater attention is now being
ity of life.
given to research leading to better methods of pre-
venting diseases.
NEW APPROACHES TO
In agriculture, growing environmental and human
health concerns coupled with new trade agreements
UNDERSTANDING DISEASE PROCESSES
and commodity price support policies require the
Federal government to reassess its science and tech-
Scientific and technological breakthroughs are provid-
nology priorities and strengthen its partnerships
ing new approaches to solving many of the long-stand-
with the states and private sector. In order to keep
ing mysteries of life and its damaging diseases. We
agribusiness strong and to ensure a safe and reli-
now have very powerful tools, developed through
able food supply, the Federal government must
advances in computing, instrumentation, and recombi-
maintain its research investments that produce new
nant DNA techniques, to help us understand what hap-
knowledge to improve environmental and human
pens when normal biological processes go awry. We are
health and expand economic opportunities.
beginning to apply this knowledge to developing ambi-
In February 1996, President Clinton released a
tious strategies to bolster our natural protection sys-
report of the National Science and Technology Council
tems and speed recovery. These tools have myriad
entitled, Meeting the Challenge: A Research Agenda for
applications that may lead to new disease treatments
America's Health, Safety, and Food. This report takes
and new methods of disease prevention. Learning how
into account the numerous changes that we are experi-
healthy cells, organs, and organ systems operate when
encing in both heálth care and agriculture. It offers
research strategies to contain health care costs while
preserving access to high quality health care services,
Using tools emerging
to develop sustainable agriculture and environmental
from the Human
Genome Project, an
management, and to contribute to our national secu-
international team
rity by enhancing international disease surveillance
tracked the gene for
and access to food.
hereditary nonpolypo-
The breadth and diversity of our Federally sup-
sis colon cancer to a
ported research activities related to improving health
region of chromosome
2. Gene-based therapies
range from fundamental research in molecular biology
may be designed to
to crop breeding programs for improved pest resis-
augment the immune
tance. This chapter highlights a number of the Admin-
system's response to
istration's accomplishments spanning the breadth of
cancer or to boost the
our health-related research portfolio, and describes
effectiveness of
chemotherapeutic
key areas of opportunity that merit enhanced support
agents.
consistent with the strategic goals articulated in Meet-
ing the Challenge.
96 Science and Technology Shaping the Twenty-First Century
y are fully functional allows us to attempt to repli-
for a fusion cofactor; in effect, the defect was a lifesaver.
cate, or add back defective pieces when necessary. For
HIV was unable to gain entry into the immune system
example, radiation or the sun's rays can damage DNA
because the cells lacked the needed receptor protein.
within the cell's nucleus, sometimes leading to skin and
NIH-supported basic biomedical research on HIV
other cancers. If we can recreate DNA repair mecha-
has allowed researchers to elucidate the viral life cycle
nisms, perhaps we may be able to prevent such damage
and identify three specific enzymes critical to HIV
in the future.
replication. One of these critical enzymes is HIV pro-
Although disease has always been part of life, certain
tease. This enzyme is involved late in the HIV replica-
behaviors and activities associated with the modern world
tion process at the stage of viral particle formation,
present numerous new health challenges. For example,
release, and maturation.
greater use of modern transportation can rapidly spread
X-ray crystallography and structure-based drug
infectious disease, unhealthy diets can led to osteoporosis
design programs have been used to determine both the
and other diet-related diseases, and smoking can result in
structure of HIV protease and other molecules that
cancer and heart disease. A greater understanding of the
might inhibit its activity. Preventing viral replication
behavioral factors and related activities underlying many
would potentially stop the spread of infection from
conditions may lead to more effective methods of interven-
HIV-infected cells to uninfected cells, ultimately halt-
tion and prevention.
ing disease progression in the patient. HIV protease
inhibitors are achieving dramatic results in some
HIV/AIDS
AIDS patients.
Acquired immunodeficiency syndrome (AIDS) is now the
ALZHEIMER'S DISEASE
leading cause of death among Americans aged 25-44. As
of June 1995, more than 500,000 cases of AIDS had been
Alzheimer's disease (AD) already affects four million
reported in the United States. It is estimated that over 20
Americans and that number will increase dramatically
"ion people world wide might be infected with the
as the baby boomers reach the age of highest risk. NIH
an immunodeficiency virus (HIV). Researchers must
scientists have identified four genes that play a role in
swer some very basic questions about how the virus
this devastating illness. Defects in either of two of
behaves within the context of the human immune system
these genes, PS1 and PS2, may be responsible for up to
before they can hope to design effective therapeutic and
80 percent of a subtype of AD that strikes before age
protective measures.
65. Recent progress in the field of protein structural
HIV infection is so different from the majority of infec-
biology is being applied to better understand neurode-
tious diseases that scientists must develop innovative and
generation and other diseases of the aging nervous sys-
diverse approaches to learning how the virus functions
tem, including AD. Sophisticated imaging technologies
and how the body responds to it. In most cases of infec-
are being used to develop structural maps and to visu-
tion, the immune system recognizes that a microorganism
alize molecular interactions in the aging brain. Under-
has invaded or damaged body cells and quickly destroys
standing the functional consequences of changes in the
the intruder. In the case of HIV, however, the target of the
3-D structure of brain proteins has the potential to
virus is a type of cell known as CD4; a part of the
identify new treatments for AD and other neurodegen-
immune system itself. CD4 cells are named for a protein
erative disorders.
receptor on the cell surface which is used by HIV to bind
to the cell. Researchers have recently confirmed that the
NEW PREVENTIVE STRATEGIES
CD4 receptor is not sufficient for the virus to fuse with
and infect the immune cells. NIH-supported scientists
AGAINST DISEASE AND DISABILITY
and others have recently discovered two cell surface pro-
teins, fusin and CCR5, that act as "cofactors," or corecep-
It is obvious that preventing disease is preferable to
tors, with CD4 that assist HIV in binding to and infecting
treating it after it occurs. Disease and disability pre-
immune cells.
vention offer the patient and the community-at-large
These discoveries are important for developing new
better quality of life and the economic benefits atten-
anti-HIV drugs to block or interfere with the binding of
dant to higher productivity. Ideally, prevention mea-
HIV to the receptors. At the same time, they may also
sures also incur lower health care costs, as in the case
'ain why some people are seemingly immune to HIV,
of vaccines. Some prevention measures, such as edu-
pite repeated exposure. Scientists have determined
cation, may be more costly or involve greater effort,
that two such individuals had inherited defective genes
but the scales are tipped in their favor in terms of
Science and Technology Shaping the Twenty-First Century 97
Pertussis Vaccine - Collaborations between NIH-supported scientists, vaccine manufacturers, and investiga-
tors around the world recently have resulted in a new class of vaccines for pertussis, or whooping cough, which
each year claims 350,000 lives worldwide, primarily infants. The pertussis vaccine type that has been the "gold
standard" for nearly 50 years is made from whole, killed pertussis-causing bacteria. It is extremely effective,
but has been associated with adverse effects more frequently than any other vaccine in general use for infants.
Many years of collaboration between NIH-supported basic scientists and the pharmaceutical industry have led
to the development of so-called acellular pertussis vaccines that use only parts of pertussis bacteria instead of
the whole organism. NIH-supported trials have demonstrated that three new acellular pertussis vaccines
markedly reduce the frequency of side effects without diminishing the vaccines effectiveness
Rotavirus Vaccine - NIH intramural scientists recently developed and patented the first vaccine against
rotavirus, the cause of infections that annually result in an estimated 130 million cases of diarrhea in infants
and children. Moderate to severe dehydration occurs in 18 million of these episodes, and more than 870,000
children world-wide die as a consequence. In the United States alone, rotaviral infections incur costs of $500
million annually in doctor visits and hospitalizations. The new vaccine protects against four different strains of
human rotavirus. Clinical trials have shown the vaccine to safely achieve significant reductions in the inci-
dence of rotavirus diarrhea. It is 80 percent protective against severe rotaviral disease and completely effective
in preventing dehydrating illness. Routine childhood vaccination against rotavirus could quickly alleviate this
major public health problem.
Hemophilus influenzae type b Vaccine - The vaccine against Hemophilus influenzae type b (Hib) menin-
gitis provides the means to completely eliminate this disease from the United States within the next few years.
For years, this disease had devastated our children, affecting 15 to 20 thousand of them each year, almost as
many as polio at its peak. Hib killed 10 percent and left one third deaf and another one third mentally
retarded, making it this country's leading cause of acquired mental retardation. Fortunately, two NIH scientists
were instrumental in developing a safe and effective vaccine which, together with three other licensed Hib vac-
cines, has reduced the incidence of Hib by 95 percent since their use began in 1988. With greater use across the
country, we have the hope of completely eliminating Hib meningitis.
societal benefits. For these reasons, prevention
stages of life includes reducing sudden infant death
research is a high priority and spans the full range of
syndrome (SIDS) and early diagnosis of osteoporosis.
biomedical and behavioral research. The latest tech-
In addition, bionutrition, including the genetic basis
nologies, such as protein engineering and recombi-
of eating disorders and pathological consequences of
nant vaccine development as well as social and behav-
particular diets, has become an important area for
ioral sciences, are being put to good use in erecting
study in prevention of disease.
effective barriers against disease and disability.
Rising health care costs increase the importance of
EMERGING INFECTIOUS DISEASES
research to prevent disease and minimize the impact
of illness and injury. New preventive strategies
To ward off pathogenic microbes, we are critically
against disease involve investigations of emerging
dependent on research to identify infectious diseases
infections, as well as the prevention and treatment of
and to provide improved drugs and new vaccines.
drug and alcohol abuse. Vaccines against cancer and
Both basic and clinical research are key, as the speed
infectious diseases such as HIV, otitis media (ear-
with which we develop the new antibiotics, new vac-
aches), herpes, chicken pox, pneumococcus, Shigella
cines, and effective treatments will depend upon our
and Salmonella, are being studied. Prevention also
understanding of the human immune system and the
entails the behavioral, genetic, and environmental
ever-growing number of pathogens that threaten
aspects of risk assessment. The control of transmis-
human health. Research must also focus on the rela-
sion of infectious disease by, for example, microbicide
tionships and linkages among disease and climate,
or behavioral changes, is an important aspect of pre-
ecological change, population growth, and human
vention research. Prevention research across all
behavior.
98 Science and Technology Shaping the Twenty-First Century
Vaccines are our strongest form of preventive medicine. Scientists supported by the National Institutes of Health
have developed new vaccines for pertussis, rotavirus, and Hemophilus influenzae type b. The latter vaccine provides the
means to completely eliminate this disease from the United States in the next few years.
BETTER HEALTH THROUGH VACCINES
Since Vice President Gore announced the Presi-
New recombinant DNA tools, advanced gene transfer tech-
dent's policy directive on emerging infectious dis-
niques, and monoclonal antibody production are greatly
eases (EID) in July 1996 (see vignette on Combat-
improving public vaccination efforts. Vaccines now in devel-
ting Ebola Hemorrhagic Fever, Chapter 3), the
opment will provide greater protection for our nation's chil-
National Science and Technology Council launched
dren against a wide range of infections and will lead to
a number of new research initiatives. To expand
reduced disease and lower health care costs. For example,
EID research, for example, NIH has funded ten
development of a vaccine against otitis media is under way.
international EID training awards and provided
Such a vaccine would benefit millions of American children
funding to expand four ongoing research and train-
who suffer from this often chronic disease, which is respon-
ing efforts related to EIDs. The VA and DOD are
sible for more than $3.5 billion worth of visits to doctors'
investing jointly in research on emerging
offices, clinics, and emergency rooms annually.
pathogens. NASA is supporting an NIH effort to
In response to a comprehensive evaluation of the NIH
study emerging viral diseases using remote sensing,
AIDS research program, NIH has established an AIDS
and the Centers for Disease Control and Prevention
Vaccine Research Committee, a highly distinguished
are cooperating with NIH on epidemiologic surveys.
group of outside advisors in immunology, virology, and
NIH also has initiated long-term programs to study
vaccinology. The committee, chaired by Nobel Laureate
hepatitis C, hantavirus, the infectious origins of
David Baltimore, will address key scientific questions in
stric ulcers, and Lyme disease. NIH and DOD are
vaccine development, including new vaccine designs,
operating on the synthesis and testing of a new
efforts to understand the mechanisms of protection in ani-
drug against the Ebola virus.
mal models, and potential new targets for vaccines.
Science and Technology Shaping the Twenty-First Century 99
c
CRAYOLA® CHROMOSOMES
1
2
3
4
5
"Toto, I have a feeling we're not in Kansas anymore
We must be over the rainbow."
Nearly 60 years after Dorothy left grey Kansas for the vibrant land
6
7
8
9
10
11
12
of Oz, wizards of a different sort have concocted a powerful new way
to visualize the full set of human chromosomes in a rainbow of col-
00
ors. The new technique, called "spectral karyotyping," translates
13
14
15
16
17
18
computer-gathered light waves into a full-color palette and assigns
each chromosome its own distinct hue. With all 23 pairs of human
chromosomes identified by a different color, scientists can more eas-
19
20
21
22
X
Y
ily examine the entire set of chromosomes for changes that could
lead to a disease, such as missing or extra pieces, or parts from
This image shows the full complement of 23
different chromosomes that have swapped places The technique
pairs of human chromosomes, each painted a dif
could prove to be extremely valuable in diagnosis of disease based
ferent color using the new labeling technique
on chromosomal alterations.
called "spectral karyotyping."
"The value of chromosome examination in understanding the
changes that take place during disease progression could be greatly enhanced if we could study the entire
genome at once, and clearly distinguish genetic material belonging to one chromosome from that of another,"
said National Human Genome Research Institute scientist Thomas Ried, who led one of two groups that
developed the technique. David Ward led a Yale University team in creating a different method that reached
the same endpoint in chromosome analysis.
The power of the current diagnostic techniques is limited in examining whole chromosome sets, called
karyotypes, for changes, because the methods rely on chemical stains that reveal only shades of gray. Pieces
moved from one chromosome to another - a process called "translocation" that is often associated with dis-
ease - cannot easily be detected. And in diseased cells containing several badly distorted chromosomes,
tracking the multiplication or exchange of genetic material is often impossible with conventional black-and-
white banding.
Chromosome banding was first developed in the early 1970s, when it was observed that each human
chromosome portrayed a characteristic pattern of bands when exposed to chemical stains. This allowed
researchers to identify and sort out human chromosomes under the microscope not only by their size but
also by their characteristic staining patterns.
PREVENTING DISABILITY AMONG OLDER AMERICANS
lems - are nearly 8-fold more likely to be involved in
automobile accidents or traffic violations compared to
Preventive health care for older Americans has a high
those with no risk factors.
payoff. More than $108 billion is spent annually on long-
term care for the elderly in the United States.
Research showed a 44 percent reduction in serious falls
Researchers are studying risk factors for disability,
among older persons through the use of interventions
improving screening processes to identify at-risk popula-
focused on physical risk factors, such as bone fragility,
tions, and designing and evaluating interventions specifi-
muscle weakness, use of sedatives or multiple medica-
cally targeted to at-risk individuals. The research is pay-
tions, and balance and walking problems.
ing off:
Elderly patients who were cared for in a special hospi-
Three short tests of physical performance abilities can
tal unit that focused on rehabilitation, prevention of
strongly predict the occurrence of disability as much as
disability, and preparation for the patient's return to
four years in advance.
home were significantly more able to perform basic
Older persons with three selected risk factors - such as
activities of daily living and less likely to need insti-
mental impairment, low physical activity, and foot prob-
tutionalized long-term care than individuals who
100 Science and Technology Shaping the Twenty-First Century
As staining techniques evolved, scientists used them to link chromosome changes to disease; missing
bands indicated a deletion of genetic material, as in some inherited diseases, whereas extra bands, or
translocations, indicated altered or additional genetic material, as is the case in many cancers.
Higher-resolution molecular techniques for visualizing chromosome regions, particularly fluorescence
in situ hybridization, or FISH, later improved the process. FISH uses DNA probes labeled with fluores
cent dyes to identify specific chromosomal regions. Spectral karyotyping is a new way to interpret data
from FISH experiments and has distinct advantages over conventional microscopy.
Ried and his coworkers applied spectral imaging, a technology used in remote sensing devices, to
chromosomes isolated from cells. First, they applied different molecular "paints" to the chromosomes.
The wavelengths of light, or emission spectra, emitted by each
c
painted chromosome provided a unique "thumbprint" for that
chromosome. Although to the eye, the thumbprints are diffi
cult to distinguish from one chromosome to the next, comput-
ers rapidly detect differences in emission spectra and assign
each chromosome its own easy-to-see color. In a spectral kary-
otype from a healthy cell, for example, computers translate the
emission spectrum for chromosome 1 into yellow, chromosome
2 red, 3 gray, 4 turquoise, and so on.
mar1 mar2 mar3 mar4 mar5 mar6
Spectral karyotyping has already been applied successfully
to analysis of cells from leukemia patients. Ried collaborated
3₈
13
with Janet Rowley from the University of Chicago to locate a
17
predicted chromosomal abnormality. In the process, several
14
4
additional translocations were identified. These types of stud-
14
14
2
8
ies will improve scientists' understanding of the genetic basis
4
6
4
8
12
3
of cancer and may ultimately assist the development of new
8
12
13
methods for cancer treatment and prevention.
In addition to its role in identifying chromosome changes
related to the progression of disease, the authors report that
This technique highlights broken and
spectral karyotyping may be valuable in comparing genomes
rearranged chromosomes in a breast cancer
cell line, a method that may lead to early diagno-
from different species to determine how genetic composition
sis of disease.
evolved over hundreds of thousands of years.
received standard hospital care. This was accom-
the discovery of human disease genes and are now
plished without increasing in-hospital or post-dis-
widely used by researchers. For example, obesity genes,
charge costs.
genes for aging, neurological disease genes, and cancer
genes, such as BRCA-1 and 2, are being identified and
GENETIC MEDICINE
characterized. Once the consequences of altered genes
are understood, rational therapies may be able to be
Genetic medicine is the application of DNA technologies
designed. Gene therapy to replace missing or defective
to the diagnosis, treatment, and prevention of disease. It
genes, is one such approach that is under investigation.
also includes analysis of complex diseases such as dia-
It has proven difficult to insert genes that operate prop-
betes and assessment of genetic risk. The mapping and
erly and produce adequate protein products.
sequencing of entire genomes (human, as well as yeast,
Most complicated diseases of modern life - cancer,
"m, fruit fly, and mouse) are critical components of
heart disease, diabetes, arthritis, and a host of neu-
tic medicine. The technological tools developed in
ropsychiatric disorders - seem to result from the activ-
ent years mapping techniques, various methods for
ities of several genes and the interactions between the
sequencing the genome, and others - have accelerated
human body and its environment. The direct causes of
Science and Technology Shaping the Twenty-First Century 101
these disorders have been difficult to discover.
this technology to the understanding of disease. The
Research at the NIH Center for Inherited Disease
Cancer Genome Anatomy Project seeks to define all the
Research will specialize in applying computer-based
genes that play a critical role in the development of
technology and robotics to conduct large-scale, rapid
cancer. The project will develop high volume, cost effec-
genetic analysis of these diseases, leading to the identi-
tive technologies to analyze the molecular mechanics of
fication of the genes involved. Developments are cur-
cancer cells and put those technologies in the hands of
rently under way to enable simultaneous analysis of
clinical researchers. Coupling these technologies with
thousands of DNA strands on a single silicon chip.
clinical investigation will provide a better understand-
These micro-machines greatly speed up research and
ing of the basis of disease, as well its detection, diagno-
lower its cost.
sis, prognosis, development of treatments, and selec-
tion of therapy.
CANCER GENETICS
December 1996 marked the twenty-fifth anniversary of
Breast Cancer - In 1995, in the United States
the war on cancer. Since 1971, scientists have discov-
alone, 182,000 new cases of breast cancer were diag
ered the causes of many cancers and have proven that
nosed. Forty-six thousand women died from the dis-
cancer can be cured. Today, more than ten million of
ease. Health care costs of breast cancer exceed $12
our family members, friends, neighbors and coworkers
billion per year. In an extension of the exciting dis
owe their lives to cancer research. Cancer survivors are
covery in 1994 of a gene that confers susceptibility,
alive today and enjoy a better quality of life because
to breast and ovarian cancer, NIH scientists and col-
the years of research in prevention, diagnosis, and
laborators discovered a specific mutation in the
treatment methods have given doctors better informa-
BRCA-1 gene in nearly 1 percent of samples of blood
tion and more accurate tools. America's youth have
from women of Ashkenazi Jewish descent. This find
received the greatest benefit from this country's invest-
ing identifies a particular subgroup of the popula-
ment in cancer research. For example, most cases of
tion that may benefit from genetic testing for the
childhood leukemia are now curable. Death rates from
BRCA-1 mutation. Epidemiologists have hypothe
children's cancers have declined by more than 62 per-
sized that this mutation may account for as much as
cent. Cancer research has also brought about dramatic
16 percent of breast and 39 percent of ovarian can-
improvements in the survival rates for adults. The
cers among Ashkenazi Jewish women age 50 and
death rate for testicular cancer, for example, has
under. Studies of families with inherited alterations
declined 66 percent and five-year survival is now 95
of BRCA-1 suggest that more than half of the
percent. Today, most Hodgkin's disease patients can be
women who inherit mutations in BRCA-1 will be
cured.
diagnosed with breast cancers by age 50, and more
Gene-based therapies are one class of exciting new
than 85 percent will have breast cancer by age 70.
approaches under investigation in cancer treatment.
These methods are designed to augment the immune
system's response to cancer or to boost the effectiveness
of chemotherapeutic agents. They may involve admin-
istration of genes for immune factors, either in the
OBESITY
patient or in cells taken from the patient and then
returned. Another method is to give the patient genes
In the United States, obesity is second only to tobacco as a
that will increase the tumor's sensitivity to an anti-
risk factor for disease and accounts for about 300,000
cancer drug, thus reducing harmful side effects on nor-
deaths per year and an economic cost of $50-$100 billion.
mal cells. Yet another technique involves the use of
Obese individuals suffer increased risk for numerous
drug-resistance genes that protect the vulnerable bone
chronic diseases, such as diabetes mellitus, cardiovascular
marrow from highly toxic chemotherapy. Important
disease, hypertension, gallbladder disease, and certain
goals for the future include the development of better
cancers. Fortunately, opportunities to attack obesity at
viral vectors for delivering genes to their intended tar-
the molecular level have multiplied. NIH-supported scien-
get cells and regulating production of the introduced
tists have made important new discoveries regarding the
genes' protein products.
obese (ob) gene, its protein product (leptin), its receptors,
A new project of the National Cancer Institute (NCI)
and its interactions with other regulators of energy expen-
provides another exciting example of the application of
diture and food intake.
102 Science and Technology Shaping the Twenty-First Century
This year, the diabetes (db) genetic mutation in the
Studies related to Alzheimer's disease in addition to
mouse and the fatty (fa) mutation in the rat (which cause
those in genetics will focus on:
diabetes in these animals) have been shown to be muta-
different aspects of the theory that components of the
tions of the leptin receptor gene. This is crucial evidence
amyloid plaques that characterize AD trigger an inflam-
of the link between diabetes and obesity.
matory immune response that is the actual cause of
Although it appears unlikely that leptin deficiency
neurodegeneration;
causes obesity in most humans, the discovery of leptin
and its receptor has already deepened our understanding
different approaches to determine whether proteins
of metabolism, and will continue to lead to fundamental
known as kinases, which have an important role in
research in the relationship between food intake, energy
normal cell function, also contribute to the formation
expenditure, and the regulation of body weight.
of the abnormal protein filaments and plaques seen
in Alzheimer's; and
BIOLOGY OF BRAIN DISORDERS
understanding of the process by which amyloid is
deposited in brain blood vessels, as a part of AD or
the normal aging process.
As we are past the midway point in the Decade of the
Brain, it is appropriate to highlight research and
progress in the neurosciences. This discipline recently
Stroke - Four out of five strokes suffered by a
joined other areas in reaping the benefits of modern biol-
half million Americans each year are caused by a
ogy by coming one step closer to deciphering the molecu-
blood clot that blocks blood flow to the brain
lar basis of memory and behavior. Two NIH-funded
With the brain starved for oxygen and other
groups, using different but related genetic techniques,
nutrients, damage follows quickly, often with dev-
reported advances in understanding how mice create a
astating consequences. Researchers recently dis-
tal map of a new environment. Using sophisticated
covered that the clot-dissolving drug TPA is an
toring equipment, researchers are able to detect
effective emergency treatment for this type of
vity in individual brain cells as the mice investigate
stroke when given within three hours of initial
their surroundings. From these data, a map of the cells
symptoms. Given the narrow window for adminis-
responsible for forming memory about space and time
tering the drug after a stroke, the challenge now
can be constructed. This work illustrates the interdisci-
is to alert physicians about this finding and, more
plinary nature of neurobiology, marrying genetics with
critically, to educate the public about the symp-
electronics to analyze cellular and biochemical processes
toms of stroke and the importance of seeking
as they occur in living organisms.
emergency help.
The biology of brain disorders encompasses studies of
the basic biology, chemistry, and anatomy of the brain,
including the physiology of the neuron, its receptors and
the neurotransmitters that are responsible for relaying
ACADEMIC HEALTH CENTERS AND THE
messages between cells. This area of research extends
studies that seek to understand the development of the
CHANGING HEALTH CARE
normal brain and the changes in development which may
ENVIRONMENT
underlie brain disorders. The research employs animal
models, neuro-imaging, and clinical studies in an effort to
Academic health centers (AHCs), medical schools,
understand many disorders, such as pain, addiction, men-
affiliated hospitals, and schools of allied health pro-
tal illness, neurodevelopmental disorders of children, neu-
fessions are the principal places in the United States
rodegenerative disease, diseases of the aging brain, and
for combining medical technological development,
damage to the sensory system.
basic and clinical biomedical research, and clinical
New or expanded NIH-supported research programs
education. In AHCs, education, research, and patient
within this area include studies on the development of
care are inextricably intertwined; patients are able
the nervous system, which have implications for the
to receive innovative medical care using the most
ability of the adult brain to repair and reorganize itself
modern techniques and can participate in research
wing injury from stroke, trauma, or degenerative
activities, and medical education is conducted. AHCs
lesses such as Parkinson's disease; and studies
also provide a disproportionately large share of this
related to spinal cord injury and neuroregeneration.
country's care of the indigent and uninsured.
Science and Technology Shaping the Twenty-First Century 103
PEREGRINE: BETTER TREATMENT FOR CANCER PATIENTS
Cancer patients may soon receive dramatically more effective radiation therapy as researchers refine and test a
revolutionary new tool for analyzing and planning treatments. The program, known as Peregrine, draws on
technologies originally developed by the national laboratories for military applications - and turns them to life-
saving use.
Peregrine addresses a straight-forward problem: Doctors have had no accurate means with which to assess
how radiation travels through the body. Each year, roughly one third of the 300,000 cancer patients doctors hope
to cure by radiation therapy die because the radiation failed to kill the original tumor. Improving the success of
radiation therapy is exceedingly difficult because without reliable, detailed information showing how radiation
is transported through tissues of different type and density, such as bone and lung, a physician trying to cure
cancer tumors with radiation is like a surgeon operating in a dimly lit theater
The Peregrine program takes advantage of increases in the speed and performance of computers, sophisti-
cated computational techniques, and comprehensive nuclear and atomic physics databases residing in the
national laboratories. It is being developed by scientists at the Lawrence Livermore National Laboratory, in col-
laboration with colleagues in medical physics and radiation oncology, and is expected to be commercially avail-
able within two years. It will provide doctors better information about where radiation is directed in the body,
greatly improving the therapy's effectiveness, raising the prospect of saving as many as 100,000 lives each year
in the United States alone.
Treatment planning based on Peregrine begins with a computer-aided three-dimensional (CT) scan that pro-
vides information about the exact location, composition, and density of the tumor and sensitive organs. These
data are subjected to a sophisticated computational technique known as Monte Carlo that calculates the proba-
bilities of random molecular interactions. The method enables doctors to track the path of an x-ray as it moves
through the body, interacting with atoms much as balls in a pinball machine bounce randomly as they encounter
obstacles in their path. The result is a detailed three-dimensional model that simulates the physical processes
involved in radiation transport.
Current methods of calculation only approximate radiation dose distribution to the patient, which can result
in underdosing of the tumor. In the tumor shown here, for example, current methods of calculation assured the
radiation oncologist that the entire tumor would be treated. But Peregrine calculations show that the prescribed
radiation targeted only a fraction of the tumor, making the treatment less effective.
Inaccurate dose calculations can have other unintended consequences, causing radiation to be directed where
it is not needed, potentially damaging healthy cells. Peregrine will allow clinicians to administer more precisely
System-wide changes in the financing and delivery
A decrease in the ability of AHCs to subsidize
of health care are having substantial effects on basic
research and teaching costs would have a negative
and clinical research and medical education in AHCs.
impact on the nation's research infrastructure and
Patient care costs historically have been higher at
on the training of the next generation of researchers
AHCs because of the added research and education
and clinicians.
missions. Yet, the latter are clearly an important and
broadly distributed public good for the future of qual-
In November 1995, the President's Committee of
ity health care in this country. The marketplace
Advisors on Science and Technology wrote to the Presi-
changes are raising important issues with respect to
dent relaying their concerns about the future vitality of
the ability of AHCs to attract the patient base needed
our AHCs. The research and educational capacity of
to support their research and education missions:
our AHCs will continue to be a factor in the Adminis-
tration's efforts to improve our health care system. It is
A decrease in the ability of AHCs to attract research
important to continue to evaluate data to determine
subjects would affect the rate at which new treat-
what impact recent changes in the health care system
ments are developed, tested, and applied.
are having on AHCs.
104 Science and Technology Shaping the Twenty-First Century
Planned Treatment:
lung Tumor- What they were treating
What they thought they were doing
Actual Treatment- What they really did
Tumor
Target Volume
Target Volume
Curative dose level
Curative dose level
Cancer patients may soon receive dramatically more effective treatment through Peregrine. This revolutionary new
technique is used to target radiation on tumors more precisely than current methods, and raises the odds of survival of the hun
dreds of thousands of cancer patients treated every year, while reducing harmful side effects. In a planned lung tumor treat-
ment using current techniques, the Peregrine calculation (right panel) shows that the intended dose misses much of the tumor.
The Peregrine program will allow more precise planning of radiation therapy.
targeted beams of radiation, giving them the confidence they need to treat tumors more aggressively, while mini-
mizing risk to healthy cells.
Monte Carlo techniques have long been recognized as the best way to calculate dose distributions for radiation
therapy, but such calculations often took hundreds of hours. Recent advances in computational techniques and
computer architecture mean dose calculations now take only minutes, not days. Peregrine brings high-speed,
zhly accurate, and high resolution Monte Carlo treatment planning to desktop computers through simple net-
rk connections, much like file servers in an office environment. Cost should thus not be a limiting factor for
ospitals who want to utilize the new treatment planning approach.
Researchers currently are examining Peregrine's application to a variety of patients and tumor types, includ-
ing tumors of the lung, head and neck, larynx, and breast. So far, researchers have assessed how well the method
would work using data only from patients who have already completed their radiation treatment. Once cleared by
the Food and Drug Administration, physicians will be able to use it for patients preparing to undergo treatment,
raising the odds of survival for hundreds of thousands of cancer patients, while reducing harmful side effects.
FOOD AND HUMAN HEALTH
NUTRITION
There is a direct link between our health and the food
Nutrition plays a pivotal role in optimizing health and
we eat. Poor diet is a significant underlying contribu-
productivity, while reducing the risk of diet-related dis-
tor to illnesses that lead to death. In addition to the
eases. The annual cost in the United States of treatment
critical relationship between diet and health, it is esti-
and care for individuals with diseases linked strongly to
mated that each year millions of individuals become ill
diet, such as cardiovascular disease, obesity, osteoporo-
and that thousands of people die from eating food con-
sis, and cataracts, exceeds $200 billion. Fortunately, over
taminated with microbial pathogens such as Salmo-
the last half of this century, we have witnessed remark-
nella and E. coli O157:H7. Research supported by the
able improvements in the dietary patterns of the U.S.
Federal government in the area of diet and nutrition
population and those of several other western industrial-
and food safety has greatly improved the overall
ized nations. Most notably these changes have brought
health of our nation's citizens. However, additional
about a decline in deaths from coronary heart disease,
research is needed to guide efforts to improve the diets
the leading cause of death in the United States. How-
Americans and to ensure that our food supply is free
ever, poor diet continues to be a leading contributing fac-
m harmful pathogenic microorganisms.
tor to numerous illnesses.
Science and Technology Shaping the Twenty-First Century 105
TOUGHER STANDARDS FOR SAFE MEAT
In July 1996, President Clinton announced sweeping reform of the nation's food safety rules, for the first time
bringing science to the task of meat and poultry inspection. The new sanitation standards and requirements for
scientific tests are designed to reveal the presence of deadly bacteria, and to maintain food safety from "farm to
table." While previous methods for inspecting meat and poultry were based on how the food looks, feels, or smells;
the new methods rely on technology to detect the bacteria E. coli and Salmonella, which are invisible without a
microscope: A similar program for seafood inspection was adopted a year earlier.
The heart of the reform is a Hazard Analysis and Critical Control Points, or HACCP (pronounced "hazup"), sys-
tem. Unlike many federal regulations, the new rules do not dictate specific steps industry must take. Instead,
packers and slaughterhouses are required to identify points in the process, such as cutting and grinding, where
contamination can occur, and then come up with remedies that prevent the contamination. To verify that the pre-
ventive steps-are effective, slaughterhouses and plants that produce raw, ground meat and poultry are required to
meet standards for Salmonella, and also to conduct microbial testing for generic E. coli (a form of E. coli that is
common in the intestinal tracts of food animals). E. coli often indicates fecal contamination, which is the main
pathway for contamination of meat and poultry.
The inspection reforms reflect recommendations during the past decade by external bodies including the
National Academy of Sciences, the General Accounting Office, and the National Advisory Committee on Microbio-
logical Criteria for Foods. Like many observers, they urged modernizing the inspection system to address the
growing hazards presented by microbial pathogens. For all our technological advances, the inspection system was
virtually unchanged for nearly a century, since muckrakers in the early 1900s exposed filthy conditions in the
nation's meat packing plants. In response, the government set up a manual system that relied on the senses of fed-
eral inspectors to protect the public from unsafe food.
Over the years, only incremental changes were made. Then, in 1993 tragedy struck people who ate undercooked
fast food hamburgers at a restaurant in the western United States. Four children died from the outbreak, and
hundreds became ill. The nation's - and the President's - attention was riveted on the threat posed by deadly
strains of E. coli, in this case E. coli O157:H7. It was clear that the inspection procedures needed to be revamped,
and government and industry began to work together in earnest to devise an effective system.
As the changes are phased in over the next
few years, industry and scientists will continue
to need additional, and more reliable, informa-
tion, and faster, more accurate test results.
Advances in biotechnology promise to provide
earlier detection of contamination. Scientists
from the U.S. Department of Agriculture have
trimmed the time required to detect disease-
causing bacteria on meat from the typical 48
hours to just five minutes. They have also
developed tests specifically to detect hemor-
rhagic E. coli O157:H7 in less than eight hours,
compared to the traditional three-day test.
None of this negates personal responsibility
for handling raw meat and poultry safely, and for
making sure it is well-cooked before it is served.
But the progress is real.As President Clinton
observed in announcing the inspection reforms,
"Parents should know that when a teenager bor-
rows the car to get a fast food hamburger, the
New scientific technology reforms meat and poultry inspection.
hamburger should be the least of their worries.
Microbial testing will be implemented in the Hazard Analysis and
Our new food safety initiative will give families
Critical Control Points program that requires the development and
the security to know that the food they eat is as
implementation of rapid tests to detect microorganisms. The two light
safe as it can be."
areas are a deadly strain of E. coli O157:H7 among colonies on non-
pathogenic strains.
106 Science and Technology Shaping the Twenty-First Century
/e still have much to learn about the prevention
impact of food-borne illnesses in this country is $6-9 billion.
or management of diet-related diseases. In particu-
The safety of the wide variety of food we consume each day
lar, we need to develop a better understanding of
starts with its production on farms, ranches, ponds, lakes,
nutrient-gene interactions so that we can produce
and oceans, and ends at the table. Further research into food
healthier food and better detect and prevent nutri-
production, harvesting, and handling practices that will
tion-related disease. An expanded human nutrition
reduce human exposure to microbial pathogens, chemicals,
knowledge base will lower health care costs and
and biotoxins - as well as into improved methods to detect
raise the effectiveness of federal food assistance pro-
and survey these hazards - can eliminate or significantly
grams, such as food stamps. Since the causes of mal-
reduce an important cause of illness in the United States.
nutrition and nutrition-related disease within the
Enhancing our strong research program in food safety
United States are complex, it is important that
will further ensure public health and safety and reduce
nutrition-related research include a multidiscipli-
the prevalence of food-borne diseases. However, we also
nary perspective.
need a system that integrates prevention, detection, and
The development of science-based programs that
intervention throughout the food production cycle, mak-
promote healthier eating habits will remain a high pri-
ing use of technological advances in food processing and
ority for the Administration. One such effort, based on
packaging, and pest control. Such a research program
a three-year tria) involving 96 elementary schools in
will build the scientific foundation for sound food safety
four states, has shown that children can be taught
regulation and policy, spur innovation in food safety and
behaviors that may protect them against heart disease.
production, and help educate consumers to improve their
Schools successfully lowered the fat content of school
food safety practices and increase their understanding of
lunches, and physical education instructors increased
the relative risks and benefits.
the amount of vigorous exercise. Students reported
Scientists are developing new ways to reduce the micro-
lower daily caloric intake from fat at home. This pro-
bial contamination of food products. Hazard Analysis and
gram worked equally well among ethnically diverse
Critical Control Point (HACCP) systems are one such
ulations and represents a cost-effective, easily
approach. HACCP is based on the premise that for overall
mented program that can have profound positive
reduction of microbial pathogen contamination of food, it
cts on children's eating habits and activity levels.
is better to reduce the level of pathogen contamination at
key points in the food production, slaughter, and process-
ing pathways rather than to simply inspect the finished
Fat Substitutes - The Federal government con-
processed product. The Administration has established
tributes to the development of a more healthful food
over the last two years new regulations that require the
supply - food that is more nutritious and low in
implementation of HACCP principles for meat, poultry,
fat. For example, Z-Trim, a new no-calorie, high-
fish, and shellfish. Research and disease surveillance are
fiber fat replacement developed by U.S. Department
needed to guide the implementation of HACCP. In particu-
of Agriculture (USDA) scientists, could soon find a
lar, research must be conducted that generates data
place in foods such as cheese products, hamburger,
needed to conduct quantitative risk assessments.
and baked goods. Z-Trim is made from low-cost agri-
The Departments of Agriculture, Health and Human
cultural byproducts such as hulls of oats, soybeans,
Services, and the Environmental Protection Agency
peas and rice, or bran from corn or wheat. The hulls
have begun a comprehensive food safety initiative
or bran are processed into microscopic fragments
which will provide an integrated federal strategy to
and purified, then dried and milled into an easy-
help ensure the microbiological safety of our nation's
flowing powder. When the fragments absorb water
food supply. Key elements to this initiative are
they swell, forming a gel that provides foods with an
improved research, surveillance, risk assessment, and
enjoyable smooth texture like that of fat.
education, all done in full cooperation with state gov-
ernments and the private sector.
FOOD SAFETY
SUSTAINABLE FOOD AND
The Centers for Disease Control and Prevention estimate that
FIBER PRODUCTION
as many as 6.5 million cases of food-borne illnesses occur
'ally in the United States, and that these illnesses con-
Agricultural productivity in the United States has
te to approximately 9,000 deaths. USDA's Economic
grown dramatically at a rate of nearly 2 percent per
Research Service estimates that the annual overall economic
year. Production has more than doubled since 1950
Science and Technology Shaping the Twenty-First Century 107
while total input use (use of energy, water, fertilizers,
An excellent example of an integrated approach to
etc.) has actually fallen slightly over this same period.
natural resource management is the USDA Forest Ser-
However, due to the new economic, environmental, and
vice's Wine Spring Basin demonstration project in
health demands being placed on our food and fiber pro-
North Carolina's Nantahala National Forest. It encom-
duction systems, we need to reassess our science and
passes about 4,500 acres and contains a mix of hard-
technology investments in agricultural research.
wood forest types, streams with native brook trout, and
Maintaining and enhancing rates of growth in food
old growth timber stands. The purpose of the project is
and fiber productivity in this new environment will be
to develop, test, and demonstrate ecologically based con-
the major science and technology challenge for agri-
cepts and technologies to restore the native mixed pine
cultural and natural resource scientists in the twenty
forest, its diverse understory, and stream habitats, as
first century.
well as to achieve a sustainable forest community. Early
Global food security remains a challenge for the
project development has centered on reintroduction of
next century. Significant uncertainties, however,
fire under prescribed conditions, testing improved
remain in projections of future world food require-
regeneration techniques for oak forest, restoring stream
ments and the ability of poor countries to achieve sus-
habitats with addition of woody debris, and a socioeco-
tainable economic and agricultural development. Sci-
nomic assessment of public attitudes and values.
entific and technical advances that improve agricul-
Our coastal waters are as productive as the richest
tural productivity can help combat the human and
American farmland. Significant strides have been
social deterioration associated with hunger and
made in restoring the living marine resource habitat
poverty. In addition to traditional aid programs, U.S.
value to areas that have been degraded through cata-
support for international agricultural research cen-
strophic events such as oil spills or ship groundings, or
ters helps build the research infrastructure in many
as a result of cumulative human activities, such as
regions of the world with persistent food production
water diversions or land use changes. Projects eventu-
problems. U.S. Land Grant universities train signifi-
ally benefiting upwards of 48,000 acres of coastal wet-
cant numbers of agricultural scientists from the
lands were initiated or under way by the end of 1996.
developing world, who in turn contribute to their
As part of the efforts to recover Pacific salmon popula-
national research programs. Working with other
tions, removal of barriers to fish migration and restora-
nations to develop the scientific tools and infrastruc-
tion of historic spawning streams have been under-
ture they need to provide for the nutritional needs of
taken, in many cases by members of the fishing indus-
their own people, the United States can help alleviate
try displaced as a result of reduced harvest levels due
the pain of hunger that afflicts 800 million people
to habitat losses and other factors. These restorations
daily.
generally represented partnerships among Federal,
state, and local governments, tribes, industry, and non-
INTEGRATED MANAGEMENT OF FARMS, RANGE-
governmental organizations.
LANDS, FORESTS, AND COASTAL WATERS
ENVIRONMENTAL QUALITY
Our nation's farms, rangelands, forests, and coastal
waters must be managed in a fashion that allows for
Reducing negative impacts on the environment or even
their long-term, sustainable use for production purposes
improving its overall health is now a major consideration
while preserving other vital functions, such as habitat for
for American food and fiber producers. This is a signifi-
wildlife, watershed protection, and recreation. To achieve
cant shift from our traditional approach to farming and
sustainable production practices, we should view our
forestry in past decades. Since the end of World War II,
farms and forests as integrated systems with a variety of
farming was geared toward optimizing production using
inputs and outputs. Scientific knowledge, generated
chemical pesticides and fertilizers or through manage-
through research, has been and will continue to be the
ment techniques that may have solved one problem but
most important factor in any sustainable production sys-
often created other, more serious ones. Excessive tillage
tem. Greater scientific understanding of the inter-relat-
to control weeds, for example, often led to unacceptable
edness of the multiple components of our nation's food
rates of erosion of valuable topsoil. Forestry was prac-
and fiber production systems, ranging from geochemical
ticed in many cases with little regard for endangered
and biological to social and economic interactions, will
species or the water quality of streams and rivers. Today
help farmers and natural resource managers understand
we are investing in science and technology to produce
what is necessary to maintain or restore the economic,
more from our food and fiber production systems while
social, and natural attributes of the system.
protecting our environment.
108 Science and Technology Shaping the Twenty-First Century
Tillage and Global Change: Keeping organic mat-
ter tucked away in soil - where it is needed most
for agricultural productivity - benefits the earth
and the atmosphere. As organic matter is plowed up,
carbon dioxide loss from the soil into the air dramat-
ically increases. Measurements of a range of soil
types, tillage methods, and climatic conditions indi-
cate that deep plowing results in a much greater loss
of carbon dioxide than all other forms of tillage. Such
information is vital in quantifying the effects of
tillage on soil quality and productivity and provides
data for validating agriculture's role in global warm-
ing. These findings offer agricultural producers a
way to help counteract global change by altering
their cultivation practices.
Protecting surface and ground water from contamination
by agricultural activities requires knowledge of land use, soil
properties and hydrogeology as exemplified by the Mahantango
Water Quality - Water pollution from agricultural
Creek watershed near Klingerstown, Pennsylvania.
chemicals must also be prevented. Combining wet-
lands, ponds, and underground irrigation could
neered crops may be environmentally beneficial in
result in water conservation and bigger yields for
many circumstances, a continuing strong research pro-
farmers. USDA scientists built such a system in
gram is important to identify and minimize any poten-
Ohio to demonstrate the benefits of recycling runoff
tial long-term negative impact this technology may
and drainage water from fields. It reduces sediment
have on the environment.
-d agricultural chemical flow to streams, improves
er quality, enhances wildlife habitat, increases
etland acreage, and improves crop yields. The wet-
GLOBAL MARKETS AND TRADE
lands remove sediment and agricultural chemicals
from field runoff. The water is then stored in a pond
Recent trade agreements such as GATT and NAFTA are
until it is needed to irrigate a field. Finally, it is
creating significant opportunities to expand interna-
pumped back through underground pipes to reduce
tional markets for U.S. agricultural products. However,
water stress in crops. The overall result is that less
with the increased trade liberalization, U.S. agriculture
pesticide and fertilizer runs off into surface waters.
faces a transition away from a system of commodity
price supports to market-driven pricing. To succeed in
this new environment, U.S. farmers will have to rely on
the latest information and newest technology. Economic
Precision farming, such as site specific application
research also is needed to support decision-making at
of pesticides and fertilizers, holds considerable promise
multiple levels from what to plant on the family farm to
for the future. Using powerful tools such as the global
negotiations of international trade agreements.
positioning system, scientists are developing techniques
Where are the most promising growth markets for
to accurately place agricultural chemicals where they
U.S. agricultural products? Will developing countries
are needed most. Current methods of chemical applica-
achieve sustainable agricultural practices or economic
tion are more "broad brush," with chemicals being
development that allows them to participate in world
applied throughout an entire field. New precision farm-
trade markets? Or will they stumble, fostering condi-
ing techniques will reduce costs by eliminating unneces-
tions for hunger, malnutrition, and political unrest?
sary chemical application, and will protect the environ-
How can we overcome unfair trade barriers to U.S.
ment by reducing the amount of chemicals applied.
agricultural products? These questions must be
New biotechnology-derived crops also have the capa-
addressed if agriculture and its related activities are to
bility to improve management practices. For example,
continue to be major contributors to our nation's econ-
plants are being developed that require fewer applica-
omy. Only through scientific and technological
; of pesticides, that require less tillage (therefore
advances, coupled with sound economic decision-mak-
ucing soil erosion), and that require less irrigation.
ing, can our nation's farmers successfully compete in
While new genetic traits and the use of genetically engi-
global markets.
Science and Technology Shaping the Twenty-First Century 109
USDA has developed new models to aid in assessing
Using science and tech-
complex trade interactions. These models effectively
nology to control pests
measure and evaluate tariff barriers to trade and esti-
is one goal of the Depart-
ment of Agriculture's inte-
mate the economic consequences of freer trade for U.S.
grated pest management
agricultural producers and consumers. This allows econ-
research. The brown citrus
omists to identify such key growth markets for U.S.
aphid is just one example
agriculture as China, Korea, Indonesia, Mexico, and
of a new pest that is
Saudi Arabia. Further, USDA research shows that
threatening U.S. agricul-
tural production.
growth in demand for U.S. exports is likely to be greater
for high-valued products, such as processed foods and
meats, than for bulk commodities. Such analysis not
only identifies opportunities for U.S. agricultural
exporters, but provides forward-looking information that
PLANT HEALTH AND INTEGRATED
can smooth out world prices when unexpected events
PEST MANAGEMENT
disrupt world markets.
Farmers generally lose 10 to 30 percent of their crops to
ANIMAL HEALTH
pests, costing them nearly a third of their production. In
addition to existing pests, farmers are continually chal-
lenged by new pests such as the Karnal bunt fungus,
Animal diseases cost the United States billions of dol-
new races of the fungus causing potato late blight, sweet
lars each year, which is why the USDA supports
potato whitefly with associated gemini viruses, and the
research addressing the health concerns of important
brown citrus aphid with the associated citrus tristeza
livestock, poultry, and aquatic species. Much of the
virus. These and other pests not only reduce profitability
research conducted by the biomedical programs of the
but often threaten export markets. The sweet potato
NIH, DOD, and VA is directly relevant to improving
whitefly has become a devastating pest of cotton, vegeta-
animal health. New vaccines, drugs, and other
bles, melons and ornamentals in the United States,
approaches to disease prevention need to be continu-
causing an estimated $500 million in crop losses annu-
ously added to the veterinarian's disease fighting
ally in this country. In Imperial County, California,
arsenal.
alone, crop losses to sweet potato whitefly have been
Production practices that result in healthy food
estimated at $100 million. USDA scientists have teamed
animals not only improve agricultural profitability
with USDA's Animal and Plant Health Inspection Ser-
and the well-being of the animals, but also improve
vice, Texas A&M University, and private industry to
human health. Animal pathogens may play a larger
develop an EPA-approved fungal pathogen that kills up
role in human health than previously thought. Some
to 90 percent of whiteflies in vegetables and melons.
human health concerns, such as E. coli O157:H7 or
Large-scale cooperative field tests have begun to refine
Salmonella infection, can be drastically reduced
pest management strategies that use the pathogen in
through improved animal health. Recent data indi-
conjunction with other biological controls. The fungal
cate a degenerative disease of the human nervous
pathogen reduces producers' dependence on chemical
system may have been transmitted from cattle
pesticides and contributes to USDA's target of 75 per-
infected with bovine spongiform encephalopathy
cent of U.S. agricultural acreage being under integrated
(BSE), also known as "mad cow disease." Unknown in
pest management (IPM) practices by the year 2000.
the United States, it has had a devastating effect on
The goal of USDA's IPM research is to reduce the
the British beef industry. USDA scientists have
use of synthetic pesticides by placing greater emphasis
developed a new test for the prion protein believed by
on natural controls, host resistance, cultural practices,
some to be linked to BSE. This test may be a promis-
biological controls, and biopesticides. The aim is to pro-
ing tool to test live animals for the presence of
duce high-quality food and agricultural products, while
scrapie (a related disease of sheep) or BSE. Scientists
maintaining farmers' profitability and protecting
at the National Institute of Neurological Disorders
human health and the environment. Research at Texas
and Stroke have also developed an assay for trans-
A&M University has saved the economy $1.5 billion
missible spongiform encephalopathies for use in
per year and spared the environment from 17.3 million
humans and non-human mammals. Ensuring the
pounds of insecticides alone. At the same time, 20,000
safety of the American beef supply will help keep
new jobs in Texas are associated with IPM. One IPM
U.S. agriculture competitive in world markets.
program in the Rio Grande Valley for carrots destined
110 Science and Technology Shaping the Twenty-First Century
baby food, soup, and frozen foods reduced insecti-
America. Therefore, we need to continue to rely on other
cide use by 66 percent while increasing individual
farmer profits by $22,000.
countries for valuable germplasm, which underpins our
nation's crop and livestock improvement efforts. We
More than 40,000 farmers have significantly reduced
must preserve the incredibly diverse gene pool of all
their use of chemical pesticides on row crops, fruits, and
plants and animals now in existence, or we risk missing
vegetables. USDA scientists, working with their counter-
important future opportunities for progress. Preserva-
parts in the Land Grant university system, have pro-
tion of existing genetic diversity is integral to improving
vided farmers with science-based information on new
our crops and livestock. Future work in germplasm
pest management practices that meet agricultural pro-
preservation and maintenance must focus on improving
duction, human health, and environmental goals. Fortu-
access to existing worldwide collections and identifying
nately, recent scientific advances, such as in molecular
gaps that exist in these collections.
biology and computer science, hold great promise for fur-
A future challenge is to establish international agree-
ther improvements in approaches to pest management.
ments that ensure access to genetic resources. For
Where effective tactics have been developed, they are
example, potato germplasm maintained in one country
widely and rapidly implemented by farmers. IPM meth-
should be accessible to the global research community so
ods are used on about half of all fruit and nut, vegetable,
that new traits, such as resistance to the fungus that
and major field crop acreage in the United States.
causes late blight, can be incorporated into potato culti-
vars in areas threatened by this pathogen. Although
countries have rights over genetic resources within their
IPM in Oregon has been proven to reduce greatly the
borders, the Administration believes that open access to
amount of pesticides applied to crops. Twenty thou-
such resources is important to improve agricultural
sand acres of Oregon apples have gone from a maxi-
species critical to global food security.
mum of three miticide applications per year to less
Research leading to improved storage and regenera-
than one under IPM. Each application costs growers
tion of germplasm in a manner that ensures its genetic
per acre. Determining the pest status on a regular
integrity is of paramount importance. We must also con-
is of 6,000 acres of pears in southern Oregon has
tinue to develop appropriate databases that document
elped eliminate 18 pounds of active pesticide ingredi-
germplasm availability, quality, and traits. To enhance
ent per acre for a savings of more than $600,000 per
germplasm traits that contribute to improved productiv-
year. An Oregon mint IPM program adds $500,000 to
ity and environmental sustainability, we should encour-
the value of the crop, since processors will not buy pep-
age multidisciplinary research approaches that combine
permint oil with pesticide residues.
the traditional tools of breeding and selection with the
new tools of molecular genetics. The public and private
sectors need to collaborate on research, development,
GENETIC RESOURCES
and technology transfer to ensure an adequate flow of
improved germplasm for major food and fiber species.
The genetic base of some important food species is
Over a century of genetics research and breeding has led
dangerously narrow. This is particularly true of fish and
to many successful improvements in plants and animals.
shellfish stocks used in aquaculture farming, including
Virtually every foodstuff and many forest species have
catfish, shrimp, oysters, and salmonids. For example, the
benefited from such improvements. Recent developments
ancestry of most of the farmed catfish stocks in the south-
in genetic manipulation and the rapid mapping of genes
ern United States can be traced to a single source of fish
are opening new possibilities, from improved disease
in Oklahoma. This greatly increases the chance of suscep-
resistance, to better taste, to longer shelf life. Access to
tibility to new or reemerging diseases and limits the pos-
genetic resources, such as gene sequencing and mapping
sibility of genetic improvements through breeding.
data, and genetic material, such as cloned genes, novel
strains, wild relatives and other plant, animal and micro-
bial germplasm, are vital to the future health of Ameri-
In 1995, the National Plant Germplasm System,
can agriculture and forestry. The development of econom-
under the auspices of USDA's Agricultural Research
ically, environmentally, and nutritionally important traits
Service, distributed approximately 120,000 samples of
will be possible only if the scientific community has
seed and clonal germplasm to both U.S. (85,000 sam-
ly access to needed genetic resources.
ples) and foreign (35,000 samples) requestors.
he majority of agriculturally important species pro-
duced in the United States did not originate in North
Science and Technology Shaping the Twenty-First Century 111
GENOMICS
INVESTING IN A BALANCED
Gene maps are powerful tools with which to genetically
AGRICULTURAL RESEARCH PORTFOLIO
improve plants, livestock, and other beneficial organisms.
Such maps and their associated DNA markers are useful
Agricultural research supported by the federal govern-
for improving the accuracy of selection of desirable new
ment requires a balanced science and technology portfo-
genotypes, moving new genes into populations, and char-
lio that encompasses a broad range of activities from
acterizing potentially valuable germplasm populations.
fundamental to applied and developmental research.
USDA scientists, working in collaboration with
Private sector research spending in agriculture has
researchers from State Agricultural Experiment Stations,
grown more rapidly than that of the public sector and
have produced genetic maps of important animals (cattle,
now accounts for more than the combined level of fed-
swine, sheep, and poultry) and plants (corn, soybean,
eral and state funding. While private sector research
loblolly pine, wheat and others), which can be accessed
spending has taken over an increasing share of the
electronically.
developmental research (that portion of research that
In general, the quality of these maps must be
promises adequate economic returns to investors), the
improved before their full potential can be brought to
opportunities for developmental research and continu-
bear on new crop and breed development. The focus of
ing technology advances depend on advances in
USDA research in the area of animal genome mapping
research funded by the Federal government and primar-
for the next five years will be on the development of
ily conducted by the USDA's Agricultural Research Ser-
markers for use in selection schemes for each of the live-
vice and State Agricultural Experiment Stations.
stock species. For plant gene mapping efforts, continued
As in other research areas, the Administration has
work is needed on improving the resolution of various
made a clear commitment to enhancing the quality and
maps and on the isolation of genes that confer desirable
accountability of Federally funded agricultural research.
traits. In addition, considerable effort needs to be given to
Rigorous peer-review, the hallmark of American science,
database development and the development of libraries of
has been promoted annually by the Administration
large genome fragments to facilitate gene identification
through the budget-setting process; science programs
and isolation.
that are based on merit review with peer evaluation are
Intellectual property rights associated with genetic
a priority. The new Fund for Rural America, supported
resources need to be addressed. While promoting technol-
by the President and established in the Federal Agricul-
ogy transfer and application in major crops, such as corn
ture Improvement and Reform Act of 1996, has strong
and wheat, patenting genetic resources and methods of
merit-review provisions. These provisions are written
genetic modification may actually impede the commer-
into the program's authorizing language and will be
cialization of biotechnology-derived minor crops, such as
implemented through peer evaluation. The National
vegetables. Companies holding patents on enabling
Research Initiative (NRI) utilizes excellent competitive
biotechnologies and genes may not be inclined to issue
peer-review procedures. Peer review procedures used by
licenses for minor uses. We need to ensure that breeders
other USDA research programs (intramural and for-
of minor crops have access to the genetic resources and
mula funds) are being assessed to determine how they
techniques needed to maintain the competitiveness of the
can be improved.
minor crops industry.
SUPPORT FOR FUNDAMENTAL AGRICULTURAL
RESEARCH
The livestock gene maps developed at the U.S.
Meat Animal Research Center in Clay Center
Increased support for fundamental research programs in
Nebraska, have over 1,300 markers for cattle, 1,100
molecular and cellular biology, physiology, and ecology
for swine, and 500 for sheep. The poultry map devel-
has expanded our understanding of fundamental
oped in cooperation with Michigan State University
processes such as pathogenesis, genetic disorders, nutri-
has over 600 markers, and is being integrated with
tion, photosynthesis, nitrogen fixation, and evolution.
the United Kingdom's poultry map.
Better understanding of these and other biological
processes leads directly to a more secure and economi-
USDA is supporting research, through the
cally competitive food and fiber supply. In addition to
National Research Initiative and the Agricultural
basic research in the biological sciences, it is important
Research Service, on gene mapping, identification,
to recognize the important contributions that research in
and characterization of over 40 crop species.
chemistry, physics, engineering, and social sciences
112 Science and Technology Shaping the Twenty-First Century
ke in agriculture through the development and adop-
tion of new enabling technologies and instrumentation.
Urea is widely applied as a nitrogen fertilizer
There is a clear need to maintain our Federal investment
because of its cost-effectiveness, ease in han-dling,
in the full range of agriculture-related science and tech-
and high nitrogen content. However, it is not effi-
nology activities, but investments in fundamental
ciently used by plants. Most of what is applied to
research are expected to generate the highest yield.
fields is degraded by soilborne microorganisms into
Therefore, the Administration will continue to provide
volatile ammonia, which is often toxic to plants.
strong support for the NRI and other programs support-
USDA's National Research Initiative has supported
ing fundamental agriculture research.
research on the enzyme responsible for the degrada
tion, urease, to determine how the enzyme works as
well as its molecular structure. A better understand
SUPPORT FOR APPLIED AGRICULTURAL RESEARCH
ing of urease sets the stage for developing safe, effec
tive inhibitors of the enzyme to improve the efficient
Agricultural problems often are based on specific soil,
use of urea by plants.
climate, or production systems that are unique to a par-
ticular region of the country. Therefore, much applied
Ethylene is a chemically simple gas that acts as a
agricultural research needs to be conducted at the local
plant hormone, regulating multiple plant processes
or regional level, and funding should be based on priori-
ranging from stem elongation to root growth and fruit
ties set regionally or locally. In addition to USDA's geo-
ripening. Work on the ethylene signal transduction
graphically dispersed intramural programs, support of
pathway supported by the Department of Energy's
applied research has been achieved primarily through
Division of Energy Bio-sciences has led to the first
state support and through various formula programs
isolation of a plant hormone receptor. These studies
where Federal funds are distributed directly to State
show that plants sense this gaseous hormone through
Agricultural Experiment Stations. Although this system
a combination of proteins that resemble signal trans-
Tederal support for applied research has substan-
duction pathways previously described in bacteria
y leveraged Federal investments, it has come under
and yeast. Genetic manipulation of these proteins will
wing stress because Federal formula funds have not
provide new tools for modifying plant growth and
grown as fast as research costs and because research
development for increased crop and biomass produc-
funds have declined in some states.
tivity.
Several steps could be taken, and in some cases are
under way, to improve the effectiveness of the current
The Departments of Energy and Agriculture and
formula-based funding programs. State Agricultural
the National Science Foundation have cooperated to
Experiment Stations are downsizing. Downsizing
fund the effort to sequence the entire genome of the
requires careful attention to priorities, with most insti-
flowering plant Arabidopsisthaliana. When com-
tutions supporting existing specific areas of excellence.
pleted, this will be the first complete DNA sequence
Severe reduction or elimination of programs is forcing
for any flowering plant. Arabidopsis is the leading
institutions to take a more regional approach to
model organism for the study of genetic traits that
addressing the needs of their clientele. Often, they rely
relate to plant growth and development and therefore
on expertise found in a neighboring state. In addition to
to traits related to crop productivity. The goal is to
downsizing, experiment stations are improving their use
complete the sequence by the year 2004.
of formula funds through creative local funding mecha-
nisms. For example, some experiment stations have
established competitive peer-reviewed funding programs
with their formula funds. Others use these funds to sup-
by the President and established in the Federal Agricul-
port young investigators or special projects
ture Improvement and Reform Act of 1996, has strong
As in other research areas, the Administration has
merit-review provisions written into the program's
made a clear commitment to enhancing the quality and
authorizing language, which will be implemented
accountability of Federally funded agricultural research.
through peer evaluation. The National Research Initia-
Rigorous peer-review, the hallmark of American science,
tive (NRI) utilizes excellent competitive peer-review
has been promoted annually by the Administration
procedures. Peer review procedures used by other
ugh the budget setting process; science programs
USDA research programs (intramural and formula
.t are based on merit review with peer evaluation are
funds) are being assessed to determine how they can be
a priority. The new Fund for Rural America, supported
improved.
Science and Technology Shaping the Twenty-First Century 113
Mentring/
mindies
Although our research universities remain
In most science fields, women receive a dispropor-
unmatched, there have been numerous indications that
tionately smaller number of degrees than men. By the
stress on these institutions is increasing. The sources of
early 1990s, women were awarded 28 percent of the
stress are varied, reflecting the broader societal trans-
doctorates in science and engineering combined, with
formations affecting many institutions. Given the impor-
great variations by broad field - one of every two
tance of the research universities and of the strong uni-
awarded in the social and behavioral sciences, one in
versity-government partnership aimed at advancing sci-
four in the natural sciences, one in ten in engineering.
ence and technology in the national interest, the
Predictably, this translates into under-representation of
Administration is heeding a call from the President's
women in the academic workforce, again with wide
Committee of Advisors on Science and Technology
variations by field and institution type. At research and
(PCAST) for a government-wide policy and administra-
doctoral institutions, women represent 35 percent of
tive review of the partnership. That partnership -
the non-science and engineering faculty. Among science
extending deep into the past century, when the Land
and engineering fields, women's faculty presence
Grant universities were founded - has been trans-
ranges from less than 6 percent in engineering and 8
formed over the last half century into the core element
percent in the physical sciences to over 20 percent in
of our world-leading science and technology enterprise.
the biological and social sciences and over 40 percent in
A multi-agency task force convened under the aus-
psychology. The picture in 1993 is similar in compre-
pices of the National Science and Technology Council
hensive and liberal arts institutions and in public and
(NSTC) will: (1) identify major stresses in the areas of
two-year institutions, except that the women are better
research, education, and administrative regulations; and
represented in all fields.
(2) determine what the Federal government's role
Participation of racial and ethnic minorities and per-
should be in addressing issues raised by this examina-
sons with disabilities leaves much room for improve-
tion. The task force findings and recommendations will
ment and continued policy considerations. At all degree
be presented in the summer of 1997.
levels in U.S. science and engineering, African-
The study may also review the mechanisms used to
Americans, Hispanics, and Native Americans remain
support graduate students, since the Federal govern-
under-represented. In any given year of this decade,
ment supports 20 percent of those enrolled in U.S. insti-
minorities awarded the Ph.D. in a science or engineer-
tutions. Since the late 1960s, the form of graduate sup-
ing field still number in the tens. The trend in minority
port has shifted significantly from fellowships and
admissions and degree awards is not encouraging.
traineeships, to research assistantships. Each of these
Thus, the pool of prospective faculty is not increasing
mechanisms vests responsibility for the graduate train-
fast enough.
ing experience in different system participants. The
Today, the science and engineering workforce hardly
portability of fellowships is attractive to the recipients,
reflects the face of America. But by 2010, about half of
while assistantships delegate responsibility for the grad-
America's school-age population will be from minority
uate research experience to faculty principal investiga-
groups, emphasizing the importance to the nation of
tors. Traineeships provide funds to departments or pro-
broader participation in science and engineering
grams with the expectation that a cadre of faculty will
careers. Expanding such participation will require
share responsibility for training new Ph.D.s, typically in
drawing on and developing talent at all stages of educa-
emerging interdisciplinary research specialties or in
tional preparation leading to advanced study. For
areas of national need as identified by Federal agency
example, only a small fraction (perhaps one-eighth) of
missions. The optimal mix for developing the nation's
all high school graduates have the mathematics and
scientific and engineering human capital needs to be
science preparation that would permit advanced study
revisited.
in a technical field; for under represented minorities,
As we work to develop the finest scientists and engi-
the fraction is only half as much.
neers for the twenty-first century, human resources pol-
The work of individuals and organizations to inspire
icy must move beyond simply the supply and demand of
and mentor young people, and offer role models is cru-
personnel and address the composition of the science
cial. To recognize this, the annual Presidential Awards
and engineering workforce. Achieving diversity through-
in Science, Mathematics, and Engineering Mentoring
out the ranks of the scientific and technical workforce
were established in 1996. Ten individuals and six orga
presents a formidable challenge; the number of women
nizations were honored for their outstanding mentorin
and minorities in science and engineering, relative even
efforts that have encouraged significant numbers of
to professions such as medicine and law, remains low.
minorities, women, and disabled persons to succeed in
We need to draw upon the full talent pool.
these fields.
124 Science and Technology Shaping the Twenty-First Century
The first recipients of the Presidential Awards for Excellence in Science, Mathematics, and Engineering
Mentoring. At the White House in September 1996, the honorees included ten individuals and six institutions that have been
exemplary in their encouragement of minorities, women, and people with disabilities to pursue careers in scientific and techni-
cal fields. Président Clinton noted that they would "serve as examples to their colleagues and will be leaders in the national
effort to train the next century's scientists, mathematicians, and engineers."
PRESIDENT OF THE OF THE THE UNITED
1996 PRESIDENTIAL AWARDS FOR EXCELLENCE IN SCIENCE,
OF
SEAL
STATES
MATHEMATICS, AND ENGINEERING MENTORING
INDIVIDUALS
INSTITUTIONS
Martha G. Absher, Duke University, Durham, NC
Columbia University Double Discovery Center,
Howard G. Adams, National Institute on Mentoring,
New York, NY
Georgia Institute of Technology, Atlanta, GA
Dartmouth College Women in Science Project,
Diola Bagayoko,
Hanover, NH
Southern University, Baton Rouge, LA
National Action Council for Minorities in
Joaquin Bustoz, Arizona State University, Tempe, AZ
Engineering, Inc. (NACME), New York, NY
Carlos G. Gutierrez, California State University-Los
New Mexico MESA, Inc., Albuquerque, NM
Angeles, Los Angeles, CA
Oregon Graduate Institute of Science &
Janet S. Herman, University of Virginia,
Technology Saturday Academy Program,
Charlottesville, VA
Portland, OR
Susan J.S. Lasser, Clemson University, Clemson, SC
University of Maryland Baltimore County,
Melvin B. Robin, Science High School, Newark, NJ
Baltimore, MD
Walter S. Smith, University of Akron, Akron, OH
Richard A. Tapia, Rice University, Houston, TX
126 Science and Technology Shaping the Twenty-First Century
TELL THEM, "YES, IT'S POSSIBLE."
As a poor, Mexican American child, Richard Tapia knew he excelled in math and science, but how his
technical abilities could lead him out of inner city Los Angeles seemed uncertain. "I just needed some
one to tell me, Yes, it's possible.'
Tapia, now director of Rice University's Department of Computational and Applied Mathematics
recalls several teachers who went the extra mile and encouraged him to "take your talent and love of
math, and make a career out of it." While building impressivetacademic and professional achieve-
ments, including nomination by President Clinton to the National Science Board that governs the
National Science Foundation (NSF), Tapia has never forgotten that one positive statement can
change someone's life forever.
In addition to teaching and research, Tapia began.and now directs all outreach programs.of the
NSF-funded Center for Research on Parallel Computation at Rice In less than ten years, these pro-
grams have trained and encouraged more than 750 students and 700 teachers, especially under rep-
resented minorities and women, to pursue careerstina
mathematics-and science He is as comfortable
speaking to a class of second-graders as to a gradu-
ate school seminar.All the while, he is urging,his
network of teachers, students, and community lead-
ers to interact with each other to make the world
better place.
Today, the importance of role modeling and men-r
toring is recognized at the highest levels. In 1996,
Tapia, along with nine other individuals and six
institutions, received a Presidential Award for
Excellence in Science, Mathematics, and Engineering
Mentoring. The awards are bestowed by the White
House Office of Science and Technology Policy
through the National Science and Technology
Council. They recognize outstanding mentoring
Honored for his mentoring efforts, Richard Tapia
efforts and programs that enhance the participation
of Rice University is flanked by Neal Lane, National
of individuals from groups under-represented in
Science Foundation Director (L) and John Gibbons,
these fields, namely minorities, women, and persons
Assistant to the President for Science and Technology.
with disabilities.
effect of social policy changes on child well-being
mary, and elementary grades, and how their experi-
and service delivery and data sources needed to
ences relate to their likelihood of succeeding in school
monitor change.
The study would encompass both a birth and kinder-
garten cohort.
Longitudinal Studies. The 1998 budget requests
Long-term follow-up studies of children provide the
additional funding for an Early Childhood
best means for assessing how child development in "nor-
Longitudinal Study (ECLS), which is to provide a com-
mal" conditions compares to what occurs in adverse con-
prehensive and reliable set of data that may be used
ditions, and how childhood and adolescent interventions
to describe and better understand children's prepara-
can best be targeted to the childhood antecedents of
tion for school, key transitions during their educa-
adult disease to prevent or delay the onset of problems in
tional careers, their experience in kindergarten, pri-
adult life.
132 Science and Technology Shaping the Twenty-First Century
Tapia's example is remarkable, but it is not unique. He and his co-recipients share President Clinton's
belief that the nation's future prosperity depends on producing the finest scientists and engineers for the
twenty-first century, and that we cannot afford to ignore the talents of people who may be outside the
economic and social mainstream.
Another award winner, Martha Shumate Absher, firmly believes that outreach is done one individual at a
time. Absher is director of outreach for the NSF Engineering Research Center for Emerging Cardiovascular
Technologies at Duke Universitv. She recalls a deaf undergraduate student she met when she visited
Washington, D.C. to interview Gallaudet University candidates for her summer program. He was a "superb
computer scientist," shè recalls, but he was discouraged and worried about how to support his wife and the
child they were expecting. He needed a job and was considering dropping out of
school. She arranged a paid research internship for him in industry for one
semester and, after the baby was born, brought the young father to Duke for
the summer program. "He did a wonderful job," and was inspired to apply to
the University of Maryland Computer Science Department, where he is now
enrolled. Without her program's support, "who knows if he could have contin-
ued?" Absher muses. "He might have been lost to the whole educational sys-
tem."
Absher's program provides laboratory research experience, and develops
mentoring relationships with students from six universities, including
Gallaudet and five Historically Black Colleges and Universities. Students from
her program often become mentors to other students. She concentrates on fol-
low-up because students who face challenges, such as disabilities, are often
unable to turn one positive experience into continued career development.
Absher and Tapia believe that government support has literally changed the
lives of students who otherwise would be unable to make the move from high
school to undergraduate school to graduate school. Both express surprise that
their award has made a difference to them but say that the personal recogni-
Martha Shumate Absher of
tion, and the visibility brought to their programs, helps them toward their goal
Duke University was honored
at a White House ceremony for
of developing a pool of highly trained scientists and engineers that reflects our
her outstanding efforts to encour-
diverse population. Especially for those students who must overcome long odds
age minorities and persons with
to pursue a technical career, mentors such as Tapia and Absher can be all-
disabilities to pursue scientific
important figures because they believe it when they say, "Yes, it's possible."
and technical careers.
Scientific research must be linked to policy. The
children to provide systematic research input to
Administration will establish, under the joint auspices
policy development, and to assist in outcome eval-
of the Domestic Policy Council and the National
uation. We owe this to our children, our families,
Science and Technology Council, a multi-agency work-
and our nation as a sound investment in the
ing group to help shape the Federal research portfolio
national interest.
on the health, education, and well-being of American
Science and Technology Shaping the Twenty-First Century 133
Moreover, during the Florio years, New
So Florio's advice to President Clinton that
failed '70s socialist policies, are withholding
painful, messy and may cost lives, but these
Jersey experie
a. sharp drop in property
he shouldn't underestimate the impact of
millions in desperately needed assistance until
small dictators have a way
coming en-
values, leaving
owners with the worst of
cuts is well-intentioned. After all, in New
,leles changes or is replaced. The absence of
trenched.
all possible wo
falling property values and
sey, tax cuts have put $1.2 billion back into
democracy thus undermines the very goals
The longer the inevitable
ontation is
rising property taxes.
paychecks of working men and women, have
the international community seeks to pre-
delayed, the higher will be the ultimate price
Since I assumed office, the state budget has
helped create 140,000 new jobs and have kept
serve.
in violence and suffering.
risen 3 percent, a noteworthy accomplishment
property tax increases at some of the lowest
Asrat and his followers-despite state-
in'a state in which, historically, the budget has
levels in years. None of that should be underes-
ponsored murders, frame-ups, torture, arrests
The writer is an American adviser to the All
doubled every six years.
timated.
and "disappearances"-have pledged them-
Amhara People's Organization, an
The former governor is disingenuous at best
selves to nonviolence. This rarity in African
opposition party in Ethiopia.
and misleading at worst when he claims that my
The writer is governor of New Jersey.
Jessica Mathews
Jack, We can walksome Gibbar of this
The Aliens Among Us
(Science 23 Aug, mumary
Same ten into GW your Crisis in Scienc
supposed requirements for life. Some archaeons
Last month, headlines blared the apparent
more about the surface of the moon than about In
can live at zero degrees centigrade. Others
Earth's deep oceans. We do not know to within
discovery of fossils of bacterial life from Mars.
thrive above the temperature of boiling water.
a factor of 10 how many species live with us
Reporters couldn't write enough about it. Phi-
Another can survive more than a million rads of
(most of the uncertainty involves the number of
losophers and clergy pondered the ultimate
radiation, making it the likely victor had the
insects) or, therefore, what percentage are be-
mysteries on uncounted talk shows.
Cold War ever erupted in nuclear holocaust,
ing lost.
giNo surprise in all that, I guess, though the
All this would be enough to stop us in our
Environmentalists agonize over the resulting
depth of our cosmic loneliness was strikingly
mental tracks with the realization of how little
dilemma: They fear that greater public aware-
evident in how little attention was paid to the
we know about life on Earth, even if the archaea
ness of what we don't know might encourage in-
discoverers' cautions about the uncertainty in
their claim or to the fact that, if real, these
comprised only a few, peculiar organisms. As it
action rather than be understood as the reason
were fossils of life that existed billions of years
turns out, living under our noses on this planet
for greater precaution in human activities that
we think we know so well is a previously unrec-
could be changing who knows what. That a spe-
ago.
What is surprising, weird in fact, is how little
ognized form of life that accounts for an eye-
cies can create a continent-sized hole in the
popping one-third to one-half of all the biomass
stratosphere and not realize it for more than a
attention was paid to the more recent an-
on Earth, much of it in the oceans.
decade is reason to worry about what we might
nouncement of the discovery of a new form of
There are several dimensions to this. First,
inadvertently do next.
life here on Earth, one whose chief author be-
BY MARGARET SCOTT
of course, is the tremendous excitement, mys-
The final irony in our enormous excitement
lieves opens a wholly new view of the uni-
verse." Media that headlined the Mars story
tery and scope of discovery that lies ahead in
about extinct life on Mars and indifference to
joined by a third. Textbooks will have to be re-
the natural sciences. Biology is going to be the
new life on Earth is that the archaea, with their
buried the Earth story or ignored it.
The announcement was of the sequencing of
written. The gene sequence proved a 20-year-
revolutionary science of the next century, as
preference for extreme conditions and their in-
the entire genome of a strange organism dis-
old hypothesis that until now has been consid-
physics has been for this one. Genome sequenc-
dependence of the sun's energy, are the perfect
ered highly controversial, if not downright nut-
ing will provide a more powerful tool for under-
candidate for alien life. "I would be surprised,"
covered near a place on the ocean floor where
ty.
standing the origin of life than the hit-or-miss
says Craig Venter, leader of the gene-sequenc-
superheated water pours out of a vent. This ec-
More than half of the genes of this amazing
search for fossils. Behavioral science and molec-
ing team, "if we don't find organisms similar to
centric beast flourishes at near boiling tempera-
tures under pressures of 200 atmospheres, far
organism turned out to be unrelated to any pre-
ular genetics will converge, yielding unimagined
this at some stage on other planets." Perhaps
viously known genes, a staggering result. Even
insights. Ecology is now only in its infancy.
archaea or something like them on a falling me-
beyond the sun's reach. All it needs to live is ni-
trogen) carbon dioxide and hydrogen, from
odder, while some are closely related to bacteri-
There's no end to the mind-bending possibili-
teor from Mars first seeded Earth's primeval
al genes, others, that direct the cell's informa-
ties. You thought that natural gas was a fossil
hot oceans. Perhaps these organisms will be
which it makes methane (natural gas).
tion processing, are similar to eukaryote genes,
fuel? Well, the genes of this organism and other
Earth's first colonists to other planets.
Its gene sequence revealed that this methan-
ococcus is in fact a member of a previously pos-
even to human genes. Archaea, it seems, par-
methane-producing archaeons might make it
One thing we know for sure. We don't need
tulated form of life called archaea. The two liv-
take of both the known domains and may be ei-
possible to produce natural gas as a renewable
tc look to outer space for heroic science:
ther their common ancestor or a giant step on
energy supply.
There's plenty right here.
ing domains that schoolchildren are taught
the way to the discovery of the root of life.
Discovery of the archaea also underlines, in a
about-prokaryotes, bacteria with no nucleus;
and eukaryotes, complex organisms from yeast
In this kingdom are creatures that seem like
way no sane person can ignore, the scope of
The writer is a senior fellow at the Council
pure science fiction. They violate many of the
what we don't know about our planet. We know
on Foreign Relations.
to humans whose cells have a nucleus-are now
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Future Support for R & D
Divider Title:
Possible paragraph on vision of future support for R&D
"I have often stated my concern that high leverage investments in America's future, such as
science, research, and education be sustained. In the long term, our economy, environment,
health, and security depend on making such commitments. Until we complete our task of
balancing the budget, however, we must constrain spending even on our best investments. I hope
that by the turn of the century, Federal support for science will begin roughly to track GDP
growth. Meanwhile, we will continue to focus on providing a constant purchasing power for
research and make further gains through productivity increases."
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FY98 R & D Budget Overview
Divider Title:
THE WHITE HOUSE
Office of Science and Technology Policy
February 6, 1997
Contact: Tim Newell (202) 456-6020
FOR IMMEDIATE RELEASE
STATEMENT BY THE ASSISTANT TO THE PRESIDENT
FOR SCIENCE AND TECHNOLOGY
JOHN H. GIBBONS
FY98 R&D BUDGET OVERVIEW
Good morning, and thank you for joining us to discuss the science and technology
investments in the FY98 budget request that the President is releasing today.
Today marks an anniversary of sorts for me. This is my fifth annual appearance before
you to present President Clinton's R&D budget request. More importantly, and more LC the
point, the President's FY98 budget marks the fifth year in a row that President Clinton DES
called for increases in science, technology and education investments.
Two days ago, in his State of the Union speech, President Clinton stated clearly his
convictions, saying that, "to prepare America for the 21st century, we must harness the
powerful forces of science and technology to benefit all Americans." This budget, as have his
past four budgets, delivers on President Clinton's commitment to maintain critical science and
technology investments as a priority while balancing the budget.
To provide you with some context, let me introduce OMB Associate Director T.J
Glauthier to review the President's overall FY98 federal budget strategy that will be presented
later this morning. (Glauthier remarks)
Now, as in past years, I would like to take just a few minutes to review the highlights
of the R&D budget request:
The President's FY98 budget increases total federal research and development
funding by more than $1.6 billion over 1997, to roughly $75 billion (as traditionally
reported). This is the fifth year in a row that President Clinton has proposed to increase
research and technology unding, at the same time that he has cut the budget deficit and has put
our country on track for a balanced budget.
1
The President's FY98 budget boosts funding for basic research. The budget
proposes $15.3 billion for basic research, an increase of $418 million (3 %) over 1997. This
includes, for example, a 4% increase for R&D at the National Science Foundation on the
civilian side, and a 5% increase in defense basic research. Basic research funded by the
Department of Energy is slated to increase by more than 4 %. In the outyears, basic research
is projected to increase steadily by nearly 5% to the year 2002.
The President's FY98 budget strengthens university-based research. University-
based research is key to America's future; it provides new knowledge and new technology,
while at the same time training the next generation of scientists and engineers. We are
proposing to increase university-based research by $289 million, to a total of $13.3 billion in
FY98.
The President's FY98 budget provides major new support for technologies that
ensure that America benefits from the revolution in information technology.
Investments in computing and communications R&D are increased by 10 %, to $1.1 billion.
This includes a 3-year, $300 million Next Generation Internet initiative. This initiative will
create the foundation for the networks of the 21st century by connecting more than 100 U.S.
universities and national labs at speeds that are 100 - 1,000 times faster than today's Internet -
with an ability to transmit voice, video and virtual reality in a secure and reliable fashion.
The FY98 budget also provides $205 million for the Department of Energy's Accelerate:
Strategic Computing Initiative (ASCI), a critical part of our Science-based Stockpile Stewardship
program. This program is producing new generations of the world's fastest supercomputers.
which will be available for both civilian and defense applications.
The FY98 Budget provides significantly increased support for programs that will
bring the power of modern information technology to classrooms throughout America.
The budget includes $524 million for research and development in education technology. This
includes $75 million for the Technology Innovation Challenge Grants program that funds
competitive grants for consortia of schools, businesses, universities, and other organizations W
develop innovative applications of innovative technology. In addition to these R&D programs.
the budget more than doubles, to $425 million, the funding for the President's $2 billion, 5-
year Technology Literacy Challenge Fund designed to stimulate public-private partnerships
focused on fully integrating education technology into teaching and learning.
2
The President's FY98 budget increases investment in technologies essential for
ensuring continued US economic leadership and job creation. A 6% increase in civilian
applied researchfensures that the U.S. will benefit from a continuing flow of technological
advances. The budget boosts investments in critical technology initiatives like the Advanced
Technology Program at the Department of Commerce, which gets a 22% increase over FY97
(to $275 million), and provides a 36% increase for the Manufacturing Extension Partnership
program that operates in close cooperation with state governments to ensure that our nation's
small and mid-sized companies are able to compete worldwide with state-of-the-art technology.
Funding for the Partnership for a New Generation of Vehicles initiative is increased 7%, to
$281 million*, and funding for the construction and building technologies initiative is
increased 15%.
The budget ensures that information technology is used effectively. Examples include
$36 million for the Department of Commerce's Telecommunications and Information
Infrastructure Assistance Program (TIIAP), and $250 million for the Intelligent Transportation
System (TTS) initiative. The ITS is critical for reducing congestion, improving the safety. and
mitigating environmental impacts of our nation's highway system.
The President's FY 98 budget includes tax incentives to encourage private sector
investment in research and technology. The budget proposes a one year extension in the
Research and Experimentation tax credit. In addition, benefits of the Foreign Sales
Corporation tax credit would be extended to computer software producers whose products are
licensed for reproduction abroad.
The President's FY98 budget increases funding for environmental research.
Science and technology investments are critical for enhancing environmental quality, and this
budget funds vital research needed to ensure clean air, pure water, and safe food. The FY98
budget allocates $5.3 billion for environmental research, a four % increase over FY97. This
funding supports a broad research agenda, including sustainable use of natural resources.
preservation of biodiversity, ecosystem management and restoration, social and economic
dimensions of environmental problems and environmental technologies. The largest
component is $1.9 billion for understanding and predicting global climate change and its
regional impacts.
This budget invests in the highest quality research aimed at understanding our most
challenging problems, coupled with development of technology to enable better environmental
protection at lower cost. The budget allocates $115 million for the STAR Program (Science
To Achieve Results), a 21 % increase over 1997 for this multi-agency program that awards
research grants and fellowships on the basis of rigorous peer review. The budget increases
support for research on the health effects of airborne particulate matter by 37 % over FY97. to
$26 million. We have increased solar and renewable energy research programs at DOE by
$60 million, or 22 %, to enable clean energy sources for the 21st century. Funding for energy
efficiency and pollution-prevention R&D increases $97 million, for a total of $517 million.
3
The President's FY98 budget provides increased support for health, food and
safety research. The budget for the National Institutes of Health (NIH) contains a 2.6 %
increase, primarily going to investigator-initiated, peer-reviewed research grants. This
increase will fund high priority research areas such as HIV/AIDS-related illnesses, breast
cancer and other women's health issues, minority health initiatives, disease prevention research
and spinal cord injury research.
The FY98 budget also contains an increase of $43 million to enhance the safety of our
nation's food supply. The President has requested a 38 % increase in the USDA's National
Research Initiative for support of investigator-initiated, peer-reviewed research grants. To
protect our health from the threat of new infectious diseases, the President's budget calls for 2
34% increase for CDC's emerging infections surveillance and response programs to $59.5
million.
The President's FY98 budget continues the President's strong support for the
nation's civil space program. The budget maintains funding for the International Space
Station program at $2.1 billion; strengthened commitment to Mission to Planet Earth at $1.42
billion (a 4% increase over FY97); and solid support for the X-33 Reusable Launch Vehicle
program ($330 million) and aeronautics initiatives ($456 million). In addition, NASA's space
science budget has been augmented by $1 billion over the next five years.
The overall out year projections for NASA in the President's FY98 budget represent 2
significant improvement over the FY97 estimates, which had the agency dropping to $11.6
billion by FY00. Under the FY98 run out, the NASA budget will go from $13.5 billion in
FY98 to $13.2 billion in FY00, then remain at that level through FY02. In total, NASA's
five-year budget has been increased by $2.7 billion compared to last year, to provide 2 stable
planning environment.
The President's FY98 request continues to support the investments in research and
technology that ensure our nation's security. We are emphasizing investments which
sustain our military defense capabilities, prevent conflict before it occurs, and address other
global threats to the well-being of our nation.
The budget maintains our long-term investments in the science and technology base and
our commitment to advancing our defense capabilities efficiently and cost-effectively. We are
requesting a 5% increase in defense-related fundamental research, which includes an 8%
increase in the basic research budget of the Department of Defense to $1.16 billion. He are
also continuing our support of defense R&D which also leverages innovation in the
commercial sector through the Dual-Use Applications Program (DUAP). The request for
DUAP is $225 million.
4
We are maintaining our priority for investments that will help to control the spread of
nuclear weapons and the materials used to make them. The FY98 budget requests a 16%
increase in the Cooperative Threat Reduction Program to $382 million. This U.S.-Russia
cooperative program has proven to be a critical investment in helping the states of the former
Soviet Union sequester, dismantle and destroy Cold War era nuclear and chemical weapons.
We are also requesting a funding increase of 21 % to $137 million to strengthen the control
and accounting of the materials that can be used to make nuclear weapons, to prevent these
materials from misuse.
We are requesting $1.4 billion for the Department of Energy's Stockpile Stewardship
Program. This program is designed to support the research needed to assure the reliability and
safety of our nuclear stockpile without nuclear testing. It underpins our commitment to the
Comprehensive Test Ban Treaty, which was signed by the President last September. We are
also requesting $1.3 billion for the construction of facilities needed for this program which
includes $900 million for the National Ignition Facility.
This sums up the S&T highlights in the FY98 budget -- I would refer you to individual
agency briefings and budgets for more details. Before taking your questions, there are two
additional points I would like to make.
First, there have been many well-publicized predictions -- fears may be a better
description - within the science community that balancing the budget would require deep cuts
in civilian research programs -- cuts on the order of one-quarter to one-third over the next five
years. Every one of my years in this office, I have heard rumors of the imminent demise of
our nation's S&T enterprise. This year is no different.
In fact, in the years between 1998 and 2002, the President's plan will preserve
civilian research funding while completing the job of balancing the budget. The
President's baseline outyear budget plan proposes civilian R&D to grow by 2% (nominal)
between 1998 and 2002. This represents a solid investment, given the fact that the budget will
eliminate the deficit (and actually produce a surplus) over the same time period. Above this
base, I fully expect some increases-including those required to launch exciting new
initiatives-to be realized each year, at the time that year's budget request is prepared and
submitted to Congress.
Second, the 1996 elections capped a year of sometimes-acrimonious debate on the role
of Federal support for science and technology. That debate may well continue, but what
emerged is clear: The American public and the vast majority in Congress support a strong
federal research program to produce new jobs and economic growth, protect the environment.
improve health care, and educate our children for the 21st century.
5
It is time to put that debate behind us and rebuild the historical bipartisan support for 2
strategy to maintain America's world leadership in science and technology into the 21st
century. We need to put our disagreements aside and look for the common ground we once
shared, the common commitments to keep America the world's undisputed leader in S&T
while bringing the budget to balance. I and my colleagues in the Administration look forward
to working with the Congress on a bipartisan basis to achieve this.
Thank you.
*Previous versions of this statement contained an incorrect funding figure for the Partnership
for a New Generation of Vehicles initiative. $281 million is the correct figure.
6
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Progress in Health
Divider Title:
Progress
#2 # 2
inner-city areas is about 50 percent. Public health measures
require an immunization rate of 80 to 90 percent of all
children to prevent the spread of outbreaks.
IMMUNIZATION
One of the greatest public health success stories for children is development of vaccines
against the infectious diseases of childhood. Work continues today to develop more
vaccines and assure that they are used for maximum benefit.
NIH- and FDA-supported research has led to the creation of important vaccinations that
have been instrumental in reducing childhood illness. For example, Hemophilus
influenza type b meningitis used to infect 15,000 children yearly, and was the leading
cause of acquired mental retardation in the United States. The vaccine these agencies
developed has nearly eliminated the disease in just six years.
NIH serves as the lead agency within the Public Health Service on the Children's Vaccine
Initiative, a global effort launched in 1990 to accelerate the development of safe,
inexpensive, orally administered vaccines. Work is under way on redesigning existing
vaccines and developing new vaccines against rotavirus diarrhea, pneumococcus,
meningococcus, Shigella dysentery, and other diseases.
CDC research showed that linking immunization services with WIC clinics could
significantly increase immunization coverage of low-income children. In 1994, CDC and
USDA developed a coordinated strategic plan to improve the immunization and general
health status of WIC participants under two years of age. CDC also helped to develop
immunization registries, a critical tool to achieve the National Goal for the Year 2000 of
having at least 90 percent of two-year-old children fully up-to-date with their
recommended immunizations. These and related efforts have brought us to the highest
levels of immunization of children in the Nation's history.
9
I. Introduction
B
y the mid-1950s, the threat of infec-
re-emerging threats in the United States
tious diseases appeared to be receding
include multi-drug resistant TB, antibiotic-
in the United States. Deaths from
resistant staphylococcal, enterococcal, and
infection, commonplace in our grandparents'
pneumococcal infections, and diarrheal
time, were no longer a frequent occurrence.
diseases caused by the parasite
American physicians used fast-acting, effec-
Cryptosporidium parvum and by certain
tive drugs to combat often fatal bacterial
strains of Escherichia coli bacteria. In fact,
diseases such as meningitis and pneumonia.
only one antibiotic remains consistently
The incidence of childhood diseases such as
effective against common hospital-acquired
polio, whooping cough, and diphtheria, was
staphylococcal infections. Meanwhile, the
declining due to the use of vaccines. Mean-
number of new antibiotics introduced into the
while, in other parts of the world, chemical
U.S. market has declined; not one new
pesticides like DDT were lowering the
incidence of malaria, a major killer of chil-
dren, by controlling populations of parasite-
carrying mosquitoes.
Savings Due voccination
As it turned out, our collective - and
Smallpox. The befieits
quite understandable -euphoria did not take
the Smallpox Eradication Broer
into account the extraordinary resilience of
been substanti the countries in
microbes, which have a remarkable ability to
the world preventive and
evolve, adapt, and develop resistance to drugs
treatment facilitie for are (11)
in an unpredictable and dynamic fashion.
longer needed The cost The United
Moreover, disease-carrying insects have
States for the success ful T3 year campaign
developed resistance to pesticides in a very
toleradidate smallpo throughout the
short time.
world was $30 million Since
Today, most health professionals agree
@smailpox eradicated 1977 the
that new microbial threats are appearing in
nine has the United
significant numbers, while well-known
"Statestevery
illnesses thought to be under control are re-
Polio. Once acommon causelof
emerging. Most Americans are aware of the
adisabilitie. or death,
epidemic of the acquired immunodeficiency
eliminated tro the Americas The current
syndrome (AIDS) and the related increase in
drive towards global eradication is one 011
tuberculosis (TB) cases in the United States.
the great challenges OF generation
In fact, there has been a general resurgence of
Once the global eradican program is
infectious diseases throughout the world,
completed target date: 2000) the United
including significant outbreaks of cholera,
State will save millions of dollars years
malaria, yellow fever, dengue, and diphtheria,
on vaccin alone. since there will
as well as illnesses caused by antibiotic-
no abe alneed.to immunize news
resistant bacteria. There has also been a
boms. FB ased on the rate
resurgence of fungal infections for which there
Aprogress towards eradica tion WHO
are very few treatments. Furthermore, the
predicista globals of $500 million
incidence of AIDS is increasing in many
by the increasing to: savings eli
countries.
$3 Ilion annually by the year 2015
New diseases have also appeared within
Other Infectious& iseas
the United States, including Lyme disease,
Childhood. Health economists estimate
Legionnaires' disease, and most recently,
that for every dollar-spent on the imeastes/
hantavirus pulmonary syndrome (HPS). HPS
Amumps/rubella $219 are saved 70
was first recognized in the southwestern
the diphtheria/tetanus/pertussis vaccine
United States in 1993 and has since been
$29 are saved; and for the polio Vaccine
detected in more than 20 states and in several
$6 are saved
other countries in the Americas. Other new or
9
and CDC. Reliable lines of communication
Interdisciplinary Research to
must be established to ensure that surveillance
support Control and Prevention.
information is received promptly enough to
Form linkages between
control outbreaks before they spread. A list of
Experimental biologists and epidemi-
clinical circumstances that require high-
ologists both here and abroad.
priority surveillance efforts is shown on page
The global infectious disease network
23.
and environmental and climatic
Diagnostic Tests. Work with WHO,
research programs.
national public health authorities, universities,
Encourage collaborative research to
and research centers to implement WHO's
determine the causes of epidemics, devise
country-level objectives. This entails deter-
strategies for control and prevention, and
mining which "common" diseases should be
identify environmental and climatic conditions
diagnosed within a country and which "un-
that favor the emergence of pathogenic
common" ones should be referred to reference
microbes.
laboratories. It also requires that diagnostic
tests be made available through a regional
laboratory referral and distribution system.
vention, noug
TEA
Develop simpler, more cost-effective
the Sex ren ein
procedures to determine the causes of disease.
Effective Preumonic Vaccine
Ideally, these procedures should be simple
the arrest Klier infant-and
enough for use in the field when laboratory
syoting Offiction ti developing countries
facilities are not available.
are Toute respiratory mainly
Support basic and applied research on
pneumonia which claim.ine lives of an
infectious microbes, especially on pathogens
estimate 3187 million children-unders
for which there are no reliable diagnostic tests.
Fevery We While
The new tools of biotechnology should be
mana using ommon antibiotes,
exploited to speed these efforts.
hasbeen very, uccessful in treating,these
Response. Enhance the capabilities of
diseases the gence of antimicrobile,
U.S. Government agencies and existing
resistant strains that this success
disease-specific networks (see page 50) to
may be relati aly Onerwayste
respond to recognized outbreaks identified
lavoid istanceris to
through improved surveillance. Also, rebuild
prevent the on fromic
and coordinate the relevant technical resources
using safe and effective vaccines
of U.S. Government agencies such as CDC,
Through bildren Vaccine
DoD, USAID, and FDA.
Project, initiating Emajo new
Diseases that are transmitted by different
program to altuate eloped)
routes will necessarily require different control
Vaccines-that may hildrensin
strategies. Types of response may include
"underdevelop Educountries): These vas
sanitation and hygiene measures, controlling
Joines are aimed against/major bacterial
populations of disease vectors (for example,
and viral.causes of pneumonia including
malaria-carrying mosquitoes or rabid rac-
Streptococ pneumoniae and
coons), drug treatment, vaccination or post-
Haemophilus influenzae by Studies in the
exposure prophylaxis, or education to decrease
industrializ world and eliminary
human behaviors that cause spread.
studies m developing countries suggest
that these illy new
"conjugated" versions hold great
promise
24
efforts must be coordinated to prevent global
of new, emerging, and re-emerging infectious
pandemics, disease surveillance must be the
diseases are identified." Soon after the
responsibility of each sovereign nation.
resolution was drafted, WHO issued a report
However, individual governments may not
urging the strengthening of global disease
easily share national disease surveillance
surveillance and control, and encouraging
information, fearing losses in trade, tourism,
greater use of WHO Collaborating Centers in
and national prestige. Nevertheless, because
this endeavor.
U.S. experts are often consulted on problems
of infectious disease recognition and control,
Are infectious disease surveillance
the U.S. Government is usually informed
and control cost-effective?
about major disease outbreaks in other
The direct and indirect costs of infectious
countries, although not always in an official or
disease are staggering (see Table 1). Clearly,
timely fashion. To ensure that we continue to
public health measures that prevent infectious
be notified when an unusual outbreak occurs,
diseases can be extremely cost-effective.
we must encourage and support other coun-
In 1994 and 1995 two major U.S. health-
tries' efforts in national disease surveillance
care expenses have been for the treatment of
and respond when asked for assistance. We
tuberculosis and AIDS. The Public Health
must strive to develop a sense of shared
Service budget for fiscal year 1996 includes
responsibility and mutual confidence in the
$343 million to combat TB and nearly $3
international effort to combat infectious
billion to combat AIDS. TB is a very old,
diseases.
well-known disease that has re-emerged
There is much room for optimism. If the
sometimes in a drug-resistant or multidrug-
United States takes the lead, we can expect
resistant form. AIDS, on the other hand, is a
that other nations will contribute resources to a
new disease, unrecognized before the 1980s.
global surveillance system. Both Canada and
When the first cases of AIDS and drug-
the European Union have recently decided -
resistant TB were detected in the United
in spite of tight budgets - to provide substan-
States, control measures were delayed, partly
tial funds ($7 and $10 million per year,
because of a lack of surveillance information
respectively) to strengthen infectious disease
and incomplete understanding of the epidemi-
surveillance and control. It is also absolutely
ology of these diseases.
critical that developing nations be engaged in
Tuberculosis
an international effort that is in their own
interests. In May 1995, WHO passed a
For many years, the United States had in
resolution urging member states "to strengthen
place a surveillance system to monitor cases of
national and local programmes of surveillance
TB. However, during the 1980s, federal and
for infectious diseases, ensuring that outbreaks
local spending on infectious disease control
Table 1 Estimated costs of common infectious diseases in the United States,
per year
Disease
Financial Cost
Intestinal infections
$23 billion in direct medical costs and lost
productivity
Food-borne diseases
$ 5-6 billion in medical and productivity costs
Sexually-transmitted diseases
(excluding AIDS)
$ 5 billion in treatment costs
Influenza
$ 5 billion (direct medical costs) and
$12 billion (lost productivity costs)
Antibiotic-resistant bacterial infections
$ 4 billion in treatment costs and increasing
Hepatitis B virus infection
$720+ million in combined direct and indirect
costs
These costs, combined with dollars spent on AIDS and TB, exceed $120 billion per year.
12
NEW MEDICINES
IN DEVELOPMENT FOR
HEART DISEASE & STROKE
Presented by the Pharmaceutical Research and Manufacturers of America
1997 Survey
New Medicines in Development Include
96 for Heart Disease and Stroke
pending billions of dollars every
year, pharmaceutical company
1997 MEDICINES IN DEVELOPMENT
research is' tackling two of the
FOR HEART DISEASE AND STROKE
nation's most vexing health problems: heart
Angina
12
attack, the number one killer of both men
and women, and high blood pressure, which
Arrhythmia
5
afflicts about 50 million Americans.
Atherosclerosis
3
Eighteen medicines are in development
Congestive Heart Failure
17
for heart attacks, which kill nearly 500,000
Coronary Artery Disease
5
Americans every year, and 10 new drugs are
being developed for high blood pressure,
Heart Attack
18
which plays a role in the more than 150,000
Hyperlipidemia
7
aths a year from stroke. Beyond the
Hypertension
10
Uman suffering, the illnesses brought on
by uncontrolled high blood pressure cost
Peripheral Vascular Disease
9
billions of dollars annually,
Stroke
22
Though There is clearly needed,
Other
27
great strides have been made. Heart attack
deaths decreased more than 30 percent
from 1981 to 1991, due in large part to bet-
In the past 30 years, the stroke death rate
death in the brain when a stroke occurs;
ter prevention, diagnosis and advancements
has declined by about 60 percent. Prevention
helping to salvage damaged brain cells; and
in medicines. Treatment of heart attacks
and medicines have both played a major role
improving recovery efforts.
with clot-dissolving drugs, for example, has
in the reduction. With continued introduc-
The commitment to battle heart disease
helped reduce deaths dramatically.
tion of new stroke medicines and continued
and stroke is now shared by 63 companies
High blood pressure, meanwhile, is
attention to reducing risk factors, scientists
as researchers strive to develop more effec-
being controlled today by increasingly effec-
predict that Americans will be able to pre-
tive medicines. When heart disease became
tive new medicines and more knowledge-
vent 80 percent of all strokes by the end of
the leading killer of Americans in 1921, few
able use of existing drugs.
treatments were available to fight it. And
New Medicines in Development for Heart
In an important step for better treat-
development of no
drugs
Disease and Stroke, a new report released by
ment, the FDA last June approved Activase,
was a slow process When President
P/RMA, shows that 96 new drugs are in
Genentech's genetically engineered clot-
Franklin Delano Roosevelt was diagnosed
development for heart disease and stroke.
dissolving agent, as a new stroke medicine.
with high blood pressure in the early 1940s,
In addition to the new drugs for heart
Stroke patients, if treated with Activase
doctors could only advise him to eat a low-
attacks and high blood pressure, other heart
within three hours, are 33 percent more
salt diet and take sedatives.
medicines in clinical testing or at the Food
likely to end up with little if any disability.
Poday, patie from wide
and Drug Administration (FDA) for final
The finding is based on a study conducted
range of medicines for heart-related ail-
review include 12 medicines for angina, 9 for
of
ments, including high blood pressure. And
peripheral vascular disease, 5 for arrhythmia
Disorders and Stroke, published in the
the 96 medicines now in development will
and 5 for coronary artery disease.
December 14, 1995 issue of the New
lead to further progress against heart dis-
Preliminary estimates indicate that the
England Journal of Medicine.
case and stroke.
pharmaceutical industry will spend $3.1
Pharmaceutical company researchers
billion on cardiovascular research in 1997.
have learned more in recent years about the
Alan &. Holmen
The 22 medicines in development for
complex mechanisms at work before, during
Alan F. Holmer
ke show researchers are trying to con-
and after a stroke. This knowledge is lead-
President
.uc progress against that feared disorder.
ing to new and better ways to limit cell
PARMA
Facts About Heart Disease and Stroke in the United States¹
Heart disease is the leading cause of death in the United States; stroke is the third. These diseases together will cost
Americans an estimated $259.1 billion this year (in direct and indirect costs).
Disease
Annual Incidence
Prevalence
Deaths
Hospitalizations and Discharges²
Angina
350,000
7.1 million
152,000 discharges
Arrhythmias
4.5 million
43,431
398,000 hospitalizations
679,000 discharges
Atherosclerosis and
2.3 million
17,980
97,000 hospitalizations
Peripheral Vascular Disease
265,000 discharges
Congestive Heart Failure
400,000
4.8 million
41,819
874,000 discharges
220,000*
Coronary Artery Disease
13.7 million
Heart Attack
1.5 million
487,490
2.1 million discharges
Hyperlipidemia
97.2 million
(cholesterol
levels
above 200)
Hypertension
50 million
38,130
372,000 discharges
(High Blood Pressure)
(age 6+)
180,000*
Stroke
500,000
3.9 million
154,350
885,000 discharges
Deaths from angina are included in total deaths from heart attacks.
Number of deaths where disease was listed as a contributing cause of death.
Key Facts:
An estimated 57.5 million Americans-more than one in five males and females-suffer from at least one form of
cardiovascular disease.
More than 954,000 Americans die from cardiovascular disease each year, representing nearly 42 percent of all
deaths in the United States. More than 2,600 Americans die each day of these diseases-an average of one death
every 33 seconds.
One in two women (50 percent) will eventually die from heart disease or stroke.
On average, someone suffers a stroke in the United States every minute; every 3.4 minutes someone dies from a
stroke.
An estimated 7.9 million Americans age 15 and older have disabilities resulting from cardiovascular conditions,
representing 19 percent of all disabilities in the United States.
Cardiovascular disease is the leading diagnosis in all hospital discharges-more than 5.8 million, almost equally
divided between males and females.
Notes:
1. 1997 Heart and Stroke Statistical Update, American Heart Association.
2. "Hospitalizations" refers to the number of patients admitted to the hospital for a specific cause; "discharges"
refers to the number of inpatients-whether alive or dead-discharged from short-stay hospitals where some type
of disease was the first listed diagnosis.
14
Improved Drugs Have Played a Key Role
In Reducing Coronary Heart Disease Deaths
By John F. Beary, III, M.D.
Senior Vice President, Regulatory and Scientific Affairs, PhRMA
D
eaths from coronary
congestive heart failure (CHF)
vessels and are taken daily by many
heart disease (CHD) in
The annual cost of CHD in the
heart patients.
1990 were 34 percent
United States is close to $80 billion
ACE inhibitors help regulate the
lower than in 1980, according to an
and consumes about 15 percent of
heart's pumping action by prevent-
article in the February 1997 issue of
the U.S. health care budget. Left
ing production of a substance that
the Journal of the American Medical
untreated, CHD can lead to
constricts blood vessels. These
Association (JAMA). The article
myocardial infarction, or heart
medicines dilate blood vessels,
attributes nearly half of the mortal-
attack, the leading cause of death
which helps to lower blood pressure
ity decline to improved medicines
for both men and women in the
in a phenomenon known as after-
and surgery techniques.
United States. About a third of the
load reduction. ACE inhibitors are
For many patients, heart disease
1.5 million Americans who suffer a
useful for both hypertension and
risk factors are controlled by drugs
heart attack each year die.
CHF.
that manage blood pressure, choles-
Nevertheless, the number of
Biomedical researchers are now
terol and diabetes. Many other
fatalities has decreased: treatment
striving to move beyond today's
heart medicines are also available,
of heart attacks with clot-dissolving
arsenal of drugs for coronary heart
including beta blockers, diuretics,
drugs, for example, has helped
disease and its complications.
antiplatelet drugs, thrombolytics
reduce heart attack deaths. The
Pharmaceutical researchers are
and ACE inhibitors.
number of drugs for treating CHD,
trying to develop new medicines
The JAMA article was written by
heart attacks and CHF has increased
based on gene therapy. Industry
a team of health policy and medical
dramatically over the years.
scientists are trying to find the
specialists from the Harvard School
Beta blockers block structures in
genes responsible for myocardial
of Public Health, Harvard Medical
the body called beta receptors.
cell growth in the heart so they can
School, the University of Groningen
These drugs, by blocking the recep-
stimulate normal production of
in the Netherlands and several
tors, reduce heart muscle oxygen
heart muscle and a return to normal
other medical centers.
demands during physical activity or
functioning after heart attacks.
CHD is a result of atherosclerosis,
excitement. Beta blockers also help
Research is also leading to a
which occurs when arteries become
to reduce blood pressure. Addition-
better understanding of the basic
narrowed or clogged by deposits of
ally, the role of beta blockers in
causes of atherosclerosis and vascular
hardened fat, cholesterol and
preventing second heart attacks is
disease. This will lead to still more
plaque. The arteries are unable to
now well established.
new treatments, such as targeted
supply enough blood for the heart's
Antiplatelet drugs, such as low-
antibody therapies directed at
needs. This can lead to chest pain
dose aspirin, help prevent clots
reducing artery-clogging plaque.
known as angina, heart attacks and
from forming in coronary blood
13
SUDDEN INFANT DEATH SYNDROME
Sudden Infant Death Syndrome (SIDS) is the leading cause of death among infants from
one month to one year of age. Though the causes of SIDS remain unknown, research
efforts have facilitated scientific breakthroughs and enabled the development of public
health strategies to combat it.
Research sponsored by the NIH over the last two decades has identified risk factors
associated with SIDS, the effects of sleep position on infant health, and other related
issues. This information led the American Academy of Pediatrics to recommend, in
1992, that babies be placed on their backs or sides to sleep. In addition, research
conducted by the CPSC provided the first epidemiologic evidence that infants who sleep
on their stomachs on top of soft bedding (e.g., pillows, comforters) are likely to rebreathe
carbon dioxide. The research showed that rebreathing carbon dioxide trapped in bedding
may have contributed to the deaths of as many as 30 percent of the infants initially
diagnosed as experiencing SIDS. CPSC warned the public about the hazards of soft
bedding through Safety Alerts, a national press conference, and by joining in the "Back to
Sleep" public health campaign. The "Back to Sleep" campaign was launched in 1994 and
sponsored by a coalition of Federal agencies, the American Academy of Pediatrics, the
SIDS Alliance, and the Association of SIDS Program Professionals.
These events have been credited with lowering the percentage of babies placed on their
stomachs to sleep from over 70 percent to less than 30 percent, and helping to reduce the
death rate from SIDS by 30 percent in the two-year period from October 1993 to October
1995. This is a prime example of how research can be linked to practice and program
development to achieve a national objective.
52
REDUCING CHILDHOOD LEAD POISONING: SIGNS OF PROGRESS¹⁴
Efforts to understand the extent of lead poisoning in America's children began to flourish
in the 1950s, as people became more aware of the harmful effects of lead exposure and
its sources. Lead poisoning adversely affects three major organ systems in the human
body: the central nervous system (specifically, the brain), the kidneys, and the blood-
forming organs. Children can experience lead exposure not only from lead-based house
paint, but also from leaded gasoline, drinking water, and household products.
Numerous Federal agencies - the EPA, the NIH, the CDC, ASTDR, HUD, and the
CPSC - have cooperated to generate the data needed to understand the consequences of
lead exposure to infants and children as well as how to prevent and treat it. One of the
greatest steps in protecting children's health occurred 20 years ago, when the EPA
phased out lead in gasoline and the CPSC also banned lead in residential paint, coatings,
and certain other consumer products.
In the 1980s, studies tracking children from birth showed that levels of lead in children's
blood previously thought to be safe were, in fact, associated with serious neurological
and behavioral problems such as impaired coordination, increased aggressiveness and
hyperactivity, and lower IQ scores. CDC revised their screening guidelines for
acceptable blood lead levels in children, from 60 g/dL in the 1960s to 10 g/dL today. In
1991, CDC recommended that virtually all children be screened for lead exposure and
poisoning.
CDC, HUD, EPA and CPSC issued strategies for elimination of lead poisoning.
Together, these efforts have led to a 98 percent reduction in lead levels in the air and
protected millions of children against serious, permanent learning disabilities. From
1976 to 1993, the percentage of children ages one to five with blood lead levels higher
than acceptable levels decreased from 88 to about 4 percent.
Though lead levels in children have significantly declined, this environmental health
hazard currently affects as many as 0.9 million children age five and under. The fact
remains that lead exposure is an entirely preventable childhood health problem. There is
still much to be done to protect children particularly those living in lower income areas
or in older homes threatened by chipping or peeling paint and excessive amounts of lead-
contaminated dust. What is more, there is a host of other environmental hazards, the
effects of which on child and adolescent development are still not fully understood; even
less is known about their cumulative effects and the risks they pose to children.
31
THE UNITED STATES EXPERIENCES DRAMATIC DECLINES IN CHILDHOOD IRON
DEFICIENCY ANEMIA 11
Iron deficiency, a widely prevalent condition in America that causes anemia, has serious
effects on the health and development of infants and children. Infants with iron
deficiency anemia have been shown to score lower on tests of mental and motor
development than their healthy counterparts. Evidence also points to long-term effects of
iron deficiency at young ages including impairment in general intelligence, language
capability, fine and gross motor skills, and visual integration.
Public policy efforts to reduce iron deficiency date back to the 1940s, when the NAS
endorsed the addition of iron to white flour and the Food and Drug Administration (FDA)
established Standards of Identity for enriched flour. By 1990, 95 percent of grain
products in the food supply were enriched, contributing to a 50 percent increase in per
capita consumption of iron.
Food assistance programs directed toward specific populations have also succeeded in
improving the iron status of these groups. The USDA's WIC program, established in the
early 1970s, is especially noteworthy. WIC provides highly nutritious, iron-fortified
food to low-income women who are pregnant or breast-feeding and to their children up to
the age of five. The program also provides nutrition education and increased access to
other health care and social services, including prenatal care. One of the goals of the
WIC program is to reduce the incidence of iron deficiency among this high-risk
population.
Research shows that the overall prevalence of anemia in children from low-income
families who participated in WIC declined from 8 percent in 1975 to about 3 percent in
1985. Among inner-city infants who were given an iron-fortified formula during the first
year of life, only 1 percent suffered from iron deficiency anemia as compared to about
9 percent of infants who did not receive an iron-fortified formula.
Despite these improvements, iron deficiency anemia in infants and children remains a
public health concern. To assure the health and well-being of America's children and
infants, continued monitoring of iron levels as well as dietary interventions are needed.
16
Clinton Presidential Records
Digital Records Marker
This is not a presidential record. This is used as an administrative
marker by the William J. Clinton Presidential Library Staff.
This marker identifies the place of a tabbed divider. Given our
digitization capabilities, we are sometimes unable to adequately
scan such dividers. The title from the original document is
indicated below.
Progress in Agriculture
Divider Title:
NABC REPORT 8
Agricultural Biotechnology:
Novel Products and New Partnerships
SHARPS
moser)
Genetic Engineering of Flavor and Shelf Life
in Fruits and Vegetables
DAVID A. EVANS
DNA Plant Technology Corp.
Oakland, Calif.
Twenty years ago, consumers only ate fruit that was "in season." Fruit was not
shipped long distances and supply was dependent on local production areas.
Demand for year-round, inexpensive produce has led to consolidation of pro-
duction where temperatures are warm, sunshine is plentiful, and labor is cheap.
In most cases, produce is now shipped long distances before being consumed.
Tomatoes grown in Mexico are trucked 3,500 miles, bananas grown in Ecuador
travel 6,000 miles on a boat, bell peppers from Holland greenhouses are flown
5,000 miles to market. Unfortunately, fruit was not designed to be shipped long
distances. In order to make it to market, fruit is picked before it is ripe (and
before it has any taste). Despite harvesting immature fruits, post-harvest losses
of fruits and vegetables still exceed 25 percent of crop production and the fruit
that makes it to market has often been described as tasteless.
STRATEGIES FOR FLAVOR AND SHELF-LIFE IMPROVEMENT
Flavor can be addressed by increasing intensity (concentration) of an impor-
tant chemical component of flavor. This can be accomplished by increasing
production of a specific compound (e.g., sucrose), by shifting the balance of
compounds (glucose versus sucrose), or by blocking production of undesirable
compounds (such as starch). Genes have been isolated to explore increased
sweetness. These include sucrose phosphate synthase (increased sucrose),
invertase (interconversion of sugars), and ADPG-pyrophosphorylase (sugar
to starch conversion).
68 Agricultural Bíotechnology: Novel Products and New Partnerships
69
Alternatively, flavor can be improved by delaying harvest until the fruit is
for 90 days. At DNA Plant Technology Corp., we completed commercial tests
ripe. Greater firmness or reduction in ethylene production can permit fruit to
on a hybrid tomato variety that was blocked for ACC-S using Transwitch™
be retained on the vine until ripe, when it has achieved full flavor potential.
,,technology. In commercial tests, these ethylene-regulated tomatoes have a 40
Increased firmness through regulation to decrease fruit softening enzymes has
day shelf-life. This includes harvest, five to seven days ethylene treatment to
met with limited success to date. Control of ethylene content appears to be
complete color development, five to seven days to ship to market, five to seven
more promising. Ethylene controls ripening and rotting in many fruits and
days storage in the local market at a repacker, seven days in the supermarket,
vegetables. By reducing ethylene concentration in fruit, it is possible to arrest
and 10 days with the consumer prior to consumption. This contrasts with the
development of the fruit and permit the fruit to remain on the vine until ripe.
maximum of 20 days for current commercial tomato varieties.
CASE STUDY: ETHYLENE REGULATED TOMATOES
The current commercial system works as follows (How, 1991):
1. Growers harvest a tomato field two or three times during a season.
Technology
All tomatoes (unless red ripe) are harvested.
Tomato fruits produce ethylene in high concentrations during ripening. There
2. Tomatoes are brought from the field to a packing shed where they are
is a burst of ethylene production, called the climacteric, that occurs when the
sorted by size and color. Tomatoes with some red color are usually sold
tomato fruit begins to turn from green to red (Grierson and Covey, 1988). The
at a discount price in the local market because they are already beginning
increased concentration of ethylene in tomato fruit is associated with color
to soften and will not survive trucking over long distances. The 90+ per-
development, fruit softening, increased respiration, and sugar accumulation.
cent green tomatoes are placed in 25 pound boxes and treated for one to
Ethylene is a simple chemical. Its biosynthesis is understood well and the genes
three days with 100-150 ppm ethylene, then trucked to a repacker at a
that are required for biosynthesis have been identified. In addition, genes have
local market.
been identified that degrade intermediates in ethylene biosynthesis.
3. Upon receipt, the repacker sorts tomatoes for color. Tomatoes that
Ethylene formation is the result of a three-step biosynthetic pathway
developed color in transit are shipped to supermarkets (or food service
(Imaseki, 1991): Methionine is converted to S-adenosyl-L-methionine (SAM)
outlets) immediately. The remaining tomatoes receive an additional two
by the enzyme methionine adenosyltransferase. SAM is converted to 1-amino-
to seven days of ethylene treatment and then are shipped to market.
cyclopropane-1-carboxylic acid (ACC) by the enzyme ACC synthase (ACC-S).
Extended shelf life provides a distinct advantage throughout the chain of
ACC is converted to ethylene by the enzyme ACC oxidase. Genes encoding
commercialization.
the enzymes involved in biosynthesis (ACC synthase and ACC oxidase) have
Grower: The ACC-S regulated tomato reaches full size and flavor potential,
been identified, isolated, and cloned. It is possible to use techniques to block
begins to degrade chlorophyll, but does not turn red in the field. At this stage,
expression of those genes, thereby blocking or reducing biosynthesis of ethy-
the tomato can remain in the field for several weeks without rotting or soften-
lene. Alternatively, enzymes have been identified in microorganisms or viruses
ing. This attribute affords the grower two benefits. First, all the tomatoes are
that metabolize the intermediates in ethylene biosynthesis. These include ACC
harvested, i.e., no over ripe tomatoes are left in the field. This increases field
deaminase, an enzyme capable of degrading ACC, and SAM hydrolase, an
yield per acre. Second, harvest costs per pound are lower because fewer total
enzyme capable of degrading SAM.
harvests are required.
The process for developing genetically engineered plants with reduced
Packer: Over-ripe tomatoes are sold at a discount in local markets (Florida,
concentrations of ethylene in the fruit is complicated and requires several
California, and Mexico). Because all the ACC-S regulated tomatoes that are
technologies that have been developed over the past twenty years. These
harvested can be shipped to remote markets, revenue per pound is increased.
technologies include gene introduction into plants, selection of transformed
In addition, tomatoes left on the vine generally increase in size. Large tomatoes
expression. cells, regeneration of plants from genetically transformed cells, and gene
command an average premium price of four to six cents per pound.
Repacker: When tomatoes arrive at a repacker they are sorted based on stage
Commercial Opportunity
of ripeness. Losses at the repacker range from six to ten percent of tomatoes
The principle commercial benefit of ethylene-regulated tomatoes is long shelf-
shipped from production areas. These are discarded tomatoes that have rotted
life. Tomatoes blocked for ACC-synthase can survive in laboratory conditions
in route or are showing signs of impending deterioration. Ethylene-regulated
tomatoes are superior, with decreased losses.
Retailer: B-
e current tomatoes rot in two to three days at retail; orders
`ene Introduction: There are two methods available for gene introd
and shipmer
made daily by most large supermarkets. Loss due to rotting
omatoes. Agrobacterium tumefaciens-mediated gene transfer is the P
can reach 20 percent of product at the retail store level. Both issues are ad-
method. Agrobacterium plasmids are modified to incorporate desired pro
CTS
dressed by a long shelf-life tomato. Moreover, better tasting tomatoes can be
and genes and the natural infection behavior of the bacterium is used to deliver
sold at a premium price, resulting in increased revenue and profit per square
the DNA into plant cells. Broad claims have not been issued on this technology.
foot in the produce section of the supermarket.
However, several components of this technology, such as the use of binary
Consumers: Because ethylene-regulated tomatoes are left on the vine until
vectors, are the subject of patents. A secondary gene introduction method is
they reach full maturity, the consumer purchases a better tasting tomato.
ballistics. Ballistics uses some method to shoot DNA into plant cells. Variations
Moreover, there should be a significant reduction in the number of rotten
on the type of microprojectile and the acceleration device have been optimized
tomatoes in consumer homes.
during experimentation for different crop plants and likely would need to be
The commercial potential of a better tasting, longer shelf-life tomato that is
optimized for tomatoes. DuPont Corp. has claims in a U.S. patent that are
sold at a premium price can be quantified as follows:
directed to the ballistics technology. Other patents are issued or pending on
various modifications of the ballistics approach for specific plant species.
per 100 lbs. harvested
standard
ethylene controlled
Plant regeneration: Regeneration using standard tissue culture methods is
Revenue
routine in tomato. The method using leaf pieces of tomatoes as explant material
$20.00
$60.00
has been used in several laboratories since the early 1980's. No broad patents
Costs
$16.00
$38.00
cover the commonly used techniques for tomato regeneration.
Margin
$ 4.00
$22.00
Promoters: A wide range of promoters have been identified that will express
DNA in plants. Some of these, including 35S, derived from cauliflower mosaic
Margin %
20%
37%
virus, are the subject of issued or pending patents (Fraley, et al., 1994). Much
effort has been directed to isolation of tissue-specific promoters. Fruit-specific
INTELLECTUAL PROPERTY
promoters in tomato would be ideal to ensure that ethylene regulation is
The technology that is required to make an ethylene-regulated tomato is the
directed to the tomato fruit and to ensure that ethylene production (involved
subject of several patents and represents a mine field that must be successfully
in disease resistance) is not blocked in leaf and other tissue.
navigated prior to introducing a product to market. The present intellectual
Selectable markers: Markers are foreign gents that are inserted into target
property situation is as follows:
plant cells at the same time as a segment of DNA that can modify ethylene.
Germplasm: Nearly all commercial acreage of fresh market tomatoes is
Because ethylene regulation cannot be selected in a test tube, the selectable
grown using proprietary seed developed by a seed company. The open polli-
marker permits transformed cells to proliferate while non-transformed cells die.
nated, publicly available varieties (e.g., Rutgers, Floradade) cannot compete
Resistance to kanamycin (conferred by the nptll gene) is a preferred selectable
with current hybrid varieties in yield and disease resistance, hence genetically
marker that has received both EPA and FDA approval for use in tomatoes and
engineered open pollinated varieties are not commercially viable. As proprietary
other crop plants. Kanamycin resistance is the subject of an issued patent in the
seed is controlled by seed companies, relationships must be negotiated with
United States and a pending patent in Europe (Rogers and Fraley, 1991).
seed companies to obtain access to parental seed for genetic engineering. The
Genes: Segments of DNA can be patented in the United States. For ethylene,
largest tomato seed companies are Seminis, Ferry Morse, and Sun Seeds. Other
patents are issued or pending on each gene that has been identified in ethylene
companies with breeding capability have developed proprietary tomato germ-
biosynthesis or degradation. For example, the USDA has a pending patent on
plasm using breeding or cellular genetics (Morrison and Evans, 1996). In
the ACC-S gene that we have used. The gene isolation work was completed at
addition to hybrids and the protection inherent in segregation of hybrid seeds,
the USDA in Albany, California (Oeller, et al., 1991). The USDA has licensed
most companies also seek Plant Variety Protection Certificates on one or both
the gene to multiple companies within different fields to ensure broad com-
of the hybrid's parents. Those layers of protection, along with seed production
mercialization of the government funded technology. Other genes have been
capability, assure seed company involvement in commercialization of geneti-
isolated including ACC-oxidase (Hamilton, et al. 1990), ACC-deaminase
cally engineered tomatoes.
(Klee, 1994), and SAM hydrolase (Good, et al., 1993).
D. Evans 73
72 Agricultural Biotechnology: Novel Products and New Partnerships
Gene expression: In order to block ethylene biosynthesis using ACC-
4. In a complex business system a novel trait may have multiple benefits.
synthase or ACC-oxidase, the endogenous genes must be regulated to decrease
The ethylene-regulated tomato provides benefits to growers, packers,
their expression. Two methods have been used in tomatoes: Transwitch
repackers, retailers, and consumers while originally targeted to increase
and antisense. Transwitch is a unique phenomenon in which some plants
shelf-life.
resulting from transformation with a homologous gene are suppressed for the
target gene (Jorgensen, 1995). Antisense achieves a similar result, i.e., gene
SUMMARY
suppression, by inserting a gene sequence that is complementary to the target
The initial hurdles for commercialization of products of plant genetic engineer-
gene (Shewmaker, et al., 1992). Each technique is the subject of issued patents
ing included technical, regulatory, and consumer acceptance. As the first prod-
in the United States and Europe.
ucts are now ready for market introduction, it is obvious that an additional
COMMERCIALIZATION IMPLICATIONS
major hurdle exists: intellectual property. Patents have been granted that cover
a number of basic biotechnology methods and the use of specific genes for
Despite the demonstrated value of ethylene-regulated tomatoes, no one is
genetic engineering. For some technologies and genes, patents already have
presently in the market with such a product. This product has extremely high
been issued and represent barriers to commercialization. For other technol-
barriers to entry due to the intellectual property situation. The companies
ogies, the patents are still pending and represent an uncertainty. Indications
closest to market are DNA Plant Technology, Monsanto/Calgene, and Zeneca
from the first products being commercialized in cotton, corn, and soybean
Plant Sciences. It is likely that each party will need licenses to intellectual
suggest that patents are being aggressively enforced and are being used to
property from other companies in order to successfully commercialize an
establish competitive advantage in the marketplace. Clearly, if broad patents
ethylene-regulated tomato. While the current patent situation presents an
are upheld by the patent office and the courts, alliances and cross licenses will
additional commercialization hurdle to the three companies, it also tends
be necessary for commercialization.
to eliminate the prospect of future new entrants developing and marketing
The modification of consumer-preferences traits could have implications
an ethylene-regulated tomato.
for several, perhaps unintended, steps in the chain of commercialization. For
RESEARCH AND PLANNING IMPLICATIONS
example, ethylene regulation in tomato will primarily result in a tomato with
longer shelf-life. However, the tomato will not be red when it reaches full
Several general lessons have been learned from attempts to commercialize
maturity, can stay in the field for a longer period of time prior to harvest,
ethylene-regulated tomatoes that apply to all commercial projects using plant
requires post-harvest ethylene treatment, and results in delivery of a better
genetic engineering.
tasting tomato to consumers. These features of the ethylene-regulated tomato
1. Many patents are still pending. Work initiated today using technology
require modification of harvest practices and modification of handling and
developed by others may never be commercialized in the absence of
packing procedures. Moreover, production trials and operation tests may
licenses. Many of the basic agricultural biotechnology patents have
suggest modification of pesticide practices, staking, and handling in the field;
not been resolved, with broad patents still possible or likely for gene
sorting, ethylene treatment, and shipping from the field; as well as packaging
introduction and gene regulation technology.
and pricing for the retailer. Ultimately, successful commercialization of new
2. In commercial or academic genetic engineering research, genes need to
consumer-preference traits in fruits and vegetables requires more than simple
be inserted into the best existing germplasm. This affords an appropriate
insertion of a gene into a plant.
benchmark to value the technology and eases adoption of new varieties.
Seed company and technology-provider alliances involving universities
and research laboratories are more likely in the future.
3. The earliest product developed is not always the first to be commercial-
ized. The complex business system of fresh market tomatoes and the
complex patent situation have delayed commercialization. If a new
genetically engineered variety requires modification of growing or
handling practices, adoption is slow.
Imut. 1996. Sheep
Nature. 380, 64-66
1, D. B. Recves, and
Phytoremediation
feactors: stable
[ sheep. Bio/Technology
BURT ENSLEY
1 testing of therapeutic
Phytotech, Inc.
Monmouth Junction, N.J.
nals. Docket no. 95D
S in the manufacture.ol
y, 1995
A. Iglesias. 1995.
munological approach
K.M. Walker, and
: dibasic cleavage site
imalian cells: Effects of
mistry. 29, 347-354
g the glycosylation
Phytoremediation is a new application of biotechnology - an exploitation of
ture Biotechnology. 14
specific plants to clean up the environment. Plants are used to treat or remove
environmental contaminants from soil and other solids like dredge spoils,
y. 14, 698-700
water, other liquids, and air.
Iman A. R. Scott and
Plants may be viewed as the original polluters. Our earth was hospitable to
2'
hits isolation
methanogenic bacteria before the evolution of photosynthesis by plants, pro-
t.
n-permissive
ducing oxygen that now is 20 percent of our atmosphere. Oxygen forced the
methanogens into anaerobic regions of the world. Now we plan to use plants
nbauer, M. G.
to help us clean up toxic soils. Scientists at the Ag Biotech Center at Rutgers
h of mice that develop
University, such as Ilya Raskin, have explored methods of using plants to treat
hormone fusion genes
organic and inorganic contaminants in soils, and have discovered that plants
provide very effective biological processes for cleaning up and removing
rymple, G. Lasser,
contaminants from the environment.
of recombinant human
I will focus on the use of plants to remove and concentrate heavy metals.
echnology. 14, 867-871
Heavy metal contaminants in the soil and water in all developed countries are
nsgenic animals. In:
a large and important worldwide problem caused by manufacturing processes
hnology's role in the
and other activities of commerce dating back to the 1700s. One may view a
V.G. Pursel and
plant as a solar driven concentrator of chemicals like metals that took 360
1 Science
million years to build, test, and optimize. The scientists at the Ag Biotech
Center enhanced that process so it is more rapid and useful for clean up at
contaminated sites.
What is the appeal of phytoremediation? First, it is an elegant method of
treating contaminated sites relative to conventional treatment methods in which
contaminated soil is transferred to a landfill (which means simply moving it
artnerships
145
somewher
), presumably for permanent storage, and then transferring
Prassica juncea (Indian Mustard) has the special property of metal acr
uncontan
on that was discovered at the AgBiotech Center by screening plants
r
4 soil to the original site. Plants leave the soil in place while
removing the contamination. Phytoremediation is cost effective, while transfer
metal uptake abilities. This metal uptake property is being expanded a.
Al-
of contaminated soils to a licensed hazardous waste site is expensive.
hanced by research including genetic engineering, mutagenesis, and selection at
Even after 25 years of cleanup efforts and growing awareness of the dangers
the Ag Biotech Center and at Phytotech. Most plants do not accumulate heavy
posed to the environment by contaminated sites, America still has a huge
metals in the stems or leaves and are not useful for phytoextraction. For most
number of contaminated sites. The main reason for the slowness of the cleanup
plants, some metal is taken up by the roots, but not much is transfered to
is the large expense of using conventional technology to clean up these sites.
the shoots and stems. Indian Mustard and Amaranthis accumulate cadmium,
We must find more cost effective methods. The use of plants helps address
hickel, zinc, copper, lead, and chrome6, a widespread pollutant in New Jersey
the economic issue. This use offers owners a new method of remediating con-
and a carcinogen.
taminated property at less cost, which presumably will accelerate the pace of
To increase availability of lead, a biodegradable, short-lived chemical is added
remediation.
to the soil to cause the plants to take up the lead. An example is the metal che-
Phytoremediation is compatible with public concerns about technology.
lator EDTA added to contaminated soil. There is a direct correlation between
People have been concerned about biotechnology. They are frightened particu-
the amount of EDTA added and the metal uptake. We are also doing environ-
larly about genetically engineered bacteria. They always will be. It is easy to
mental impact rates and effect studies to evaluate the environmental impact,
frighten people about bacteria. For example, when you tell people how many
good and bad, of removing metal from the soil by growing the plants on site
bacteria there are in yogurt, it doesn't make them think better of the bacteria,
and adding chemicals to induce uptake and clean the site.
it makes them quit eating yogurt. Plants are something that everyone can see;
We are in the process of modeling, analyzing, and monitoring the impact
they are familiar and therefore comfortable with plants. Using plants to clean
of this approach to remediating contaminated sites. What do you do with the
up a contaminated site is more acceptable to community members than the use
harvested plants following phytoextraction? We dry the plants, may incinerate
of bacteria.
them, may compost them, or may compact them by pressing followed by acid
At the time of the Exxon Valdez oil spill, the state of Alaska decreed that no
leaching and disposal, or recycling, of the heavy metal. The volume or mass of
non-Alaskan micro-organisms could be used. This was the first microbial-
the plants that contain the extracted heavy metals is only about two percent of
immigration policy and it was useless. Bacteria travel on the wind, and in many
the volume or mass of contaminated soil. This is a 50-fold concentration.
other ways, and they didn't seek Alaskan regulators' permission before they
Indian Mustard has many attractive characteristics for cleaning up toxic
entered Alaskan waters to eat the oil on the beach.
metal sites. It is inexpensive to grow and grows very rapidly to about five feet
Phytoremediation is sophisticated scientifically. Technology must be devel-
in about two months, producing 2-10 tons/hectare of dry weight with fairly
oped so it can be safe, effective, and reliable.
rapid clean up of the site. We believe there are a significant number of con-
Over the next five years the United States will spend $43 million to treat only
taminated heavy metal sites in the U.S. that could be remediated in about three
sites contaminated with heavy metals and heavy metals mixed with organics.
years or less so that the Environmental Protection Agency or the state environ-
That's not what would be needed to clean up all the sites. We need low-cost
mental agency would conclude that that site was safe for use. We have great
approaches so that we can accelerate the pace of remediation.
hope that we will be able to use phytoremediation as an effective technology.
Phytoextraction is the subset of phytoremediation in which plants remove
We have treated a site in the middle of an urban environment, Magic Marker,
contaminating toxic or radioactive metals from a site by root uptake and
in Trenton, N.J. It was originally contaminated by a battery manufacturing and
accumulation in the plant shoots.
recycling facility located there since about 1950.
I will describe the use of a plant - Indian Mustard - to remove lead from a
Other sites that we have examined in Trenton and other New Jersey towns
toxic site. The plants are watered with agricultural chemicals that make the lead
were contaminated in the 1700s and 1800s by practices such as pottery making.
water soluble. The water containing lead is taken up by the roots and moved
Trenton was a big pottery making center at one time. Pottery glazes contained
into the stems and leaves where it evaporates, leaving the concentrated lead in
lead or cadmium and there is a large number of lead and cadmium contami-
the plant. The harvested plants may be sent to a smelter where the metal is
nated sites in the city of Trenton.
recycled - a hazardous waste is removed from the environment and recycled to
The Magic Market site was blocked out, samples were taken to establish lead
commerce. This technology, developed by the Ag Biotech Center, is the subject
content, the site was plowed, and fertilizer was added. The soil on the site is
of a technology transfer agreement between Rutgers University and Phytotech.
dark, not because of humus, but due to the asphalt in the soil. The site was
146 Agricultural Biotechnology: Novel Products and New Partnerships
Ensley
147
onc
rking lot. An irrigation system was installed and Indian Mustard wa.
hydroseeded to evenly distribute the seeds without disturbing the soil.
We collaborated with the local residents. There was a Phytoremediation Day
in Trenton. Through an organization called Isles Inc., we attended community
meetings, told everybody that lived in the area (there are houses all around this
Agricultural Biotechnology:
site) what we were doing, and invited everyone to attend the first planting. The
A Farmer's Perspective
costs of those trials were paid by Phytotech, which had raised $6 million of
venture capital and has 16 employees.
MARY Lou GARR
As indicated in my presentation, we are enthusiastic about the role of
phytoremediation in the cleanup of toxic sites.
Ontario Federation of Agriculture
Beamsville, Ontario, Canada
I am particularly pleased and somewhat surprised to be a speaker today, given
that I am neither a scientist nor an expert in biotechnology. Frankly, I have
only a limited understanding of biotechnology. I'm just a plain ordinary family
farmer from a long line of plain ordinary family farmers. However, this humble
status has never prevented me from striving to make as much money as pos-
sible and I see exciting opportunities ahead to do just that: rapid improvements
in the quality of crops, livestock, and livestock products; huge reductions in
input usage and costs of production; and the creation of new consumer prod-
ucts. In fact, I expect that my family farming operation will be fundamentally
changed over the next few years because of the things most of you are doing.
However, in the push to advance the field of agricultural biotechnology,
farmers are often the last to be considered or consulted. Does the research
always meet our production needs? Does the regulatory system provide for
timely approvals of new technologies? Are farmers sought out to participate
in forums like this?
At NABC 7, held in May, 1995, I met very few farmers, though I found our
input in workshops much appreciated. This year, I doubt I'd see many hands
raised if I asked how many people rely on farming for their income. Yet farmers
are your critical link in the biotechnology path to market. We utilize the re-
search and produce the product which then must be marketed and find public
acceptance. And all this in a world where the anti-technology crowd is way out
in front in shaping public opinion.
Most farmers are cautiously optimistic about agricultural biotechnology,
but they need someone to take leadership in managing this controversial issue
on their behalf.
148 Agricultural Biotechnology: Novel Products and New Partnerships
149
Plant Beotech
Plant-Microbe Interactions: An Overview
1667
of molecular genetic manipulations that have been so infor-
gineer crop plants that express novel or altered specificities
mative in other symbioses. It will be most interesting to
and therefore exhibit broad spectrum resistance to disease.
determine whether any of the plant genes with a critical role
Disease control strategies based on a more detailed under-
in legume nodule initiation are also involved in the establish-
standing of the intricate relationships among roots, pathogens,
ment of actinorhizal symbioses.
and beneficial microbes in the rhizosphere are also forthcom-
One significant difference between legume and actinorhizal
ing. Strategies hinging on the deployment of decoy molecules
nodules is the site at which root cells become reactivated to
that contribute to shifts in the expression of pathogen virulence
form nodule primordia. In rhizobial symbioses, cortical cells
genes or that affect the ability of rhizosphere pathogens to
are activated to reenter the cell cycle, whereas in actinorhizal
compete with benign soil organisms could well be realized.
symbioses, pericycle cells are activated. The early phases of
It has been enormously satisfying to participate in the for-
quite similar to lateral
mulation and editing of this Special Issue of THE PLANT CELL.
eling hypotheisize that
Collectively, the reviews in this issue offer an outstanding anal-
ag-
this developmental pro-
ysis of our current knowledge of plant-microbe interactions
and the plant and microbial processes upon which they de-
progress
lutionary origin of sym-
pend. The insight gained from these analyses are already
in this review. Although
impacting studies of plant development and responses to the
#2
wlowski and Bisseling
environment. We fully anticipate that you will enjoy reading
volve from pathogenic
these reviews as much as we have enjoyed editing them!
ct? Why are nitrogen-
S of two plant families,
whereas mycorrnizar association widespread? Answers
REFERENCES
to these questions are of considerable practical value and may
provide fundamental insight into the evolution and operation
Agrios, G.N. (1988). Plant Pathology (San Diego: Academic Press).
of many plant-microbe interactions.
Carefoot, G.L., and Sprott, E.R. (1967). Famine on the Wind (Chicago:
Rand McNally and Co.).
Cotter, P.A., and Miller, J.F. (1996). Triggering bacterial virulence.
CONCLUDING REMARKS
Science 273, 1183-1184.
Dropkin, V.H. (1989). Nematology (London: John Wiley and Sons).
The rapid progress that continues to be made in our elucida-
Flor, H.H. (1971). The current status of the gene-for-gene concept. Annu.
Rev. Phytopathol. 9, 275-296.
tion of plant-microbe interactions is contributing to major
advances in our understanding of plant and microbe cell biol-
Fullner, K.J., Lara, J.C., and Nester, E.W. (1996). Pilus assembly by
Agrobacterium T-DNA transfer genes. Science 273, 1107-1109.
ogy and biochemistry. On the pathogen side, studies reported
in this issue provide illuminating information concerning the
Fulton, R.W. (1986). Practices and precautions in the use of cross-
protection for virus disease control. Annu. Rev. Phytopathol. 24,
evolution of virulence, the signaling processes involved in sym-
67-81.
biotic relationships, pathogenesis, and resistance responses,
Harrison, M.J. (1996). A sugar transporter from Medicago truncatula:
and the nature of protective mechanisms relevant to the ecol-
Altered expression patterns in roots during vesicular-arbuscular (VA)
ogy and survival of nonpathogenic microbes.
mycorrhizal associations. Plant J. 9, 491-503.
On the plant side, studies of plant-microbe interactions have
Janda, M., and Ahiquist, P. (1993). RNA-dependent replication tran-
led to the development of a wide range of model systems that
scription and persistence of brome mosaic virus RNA replicons in
can be used to probe normal cell biological processes. For
Saccharomyces cerevisiae. Cell 72, 961-970.
example, the recent suggestion that plant pathogenic bacte-
Jones, J.B., Jones, J.P., Stall, R.E., and Zitter, T.A. (1991). Com-
ria export virulence factors directly into plant cells is an exciting
pendium of Tomato Diseases (St. Paul, MN: APS Press).
concept that impacts investigations of both plant and animal
Large, C.E. (1940). Advance of the Fungi (New York: Dover
diseases. Similarly, identifying the host components that are
Publications).
involved in plant virus replication and movement should prove
Lomonossoff, G.P. (1995). Pathogen-derived resistance to plant
helpful for understanding the intricacies of plant nucleic acid
viruses. Annu. Rev. Phytopathol. 33, 323-343.
metabolism. The same systems are also providing informa-
Lucas, W.J., Bouche-Pillon, S., Jackson, D.P., Nguyen, L., Baker,
tion about the role of the cytoskeleton in macromolecular
L., Ding, B., and Hake, S. (1995). Selective trafficking of Knotted1
targeting and the potential developmental impact of diffusion
homeodomain protein and its mRNA through plasmodesmata.
gradients that may be created by cell-to-cell transport of these
Science 270, 1980-1983.
macromolecules.
Moré, M.I., Finger, L.D., Stryker, J.L., Fuqua, C., Eberhard, A., and
The practical utility of understanding plant-microbe inter-
Winans, S.C. (1996). Enzymatic synthesis of a quorum-sensing au-
actions is obvious. For example, as the bases for the astounding
toinducer through use of defined substrates. Science 272, 1655-1658.
specificity that is typical of most host resistance responses
Murphy, F.A., Fauquet, C.M., Bishop, D.H.L., Gabriel, S.A., Jarvis,
are unravelled, it should become possible to genetically en-
A.W., Martelli, G.P., Mayo, M.A., and Summers, M.D. (1995). Virus
05/09/97
08:52
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LPA-MEDIA SVCS
002/003
Ride published in FR 5-2-97
United States
APHIS
Department of
Brotech
Agriculture
Ref.
streamly
Animal and
Jim Rogers
(301) 734-3256
News
Plant Health
[email protected]
Inspection
Jerry Redding (202) 720-6959
Service
[email protected]
Beg
USDA AMENDS REGULATIONS FOR GENETICALLY ENGINEERED ORGANISMS
WASHINGTON, May 1, 1997--The U.S. Department of Agriculture is amending
its regulations pertaining to genetically engineered plants introduced under
USDA's notification and petition regulatory processes.
"The amendment will simplify procedures for the introduction of certain
genetically engineered organisms, expedite review for certain determinations
of nonregulated status, and adjust procedures for the reporting of field tests
Speed process
conducted under notification to the biology of the test organisms," said John
Payne, director for biotechnology and scientific services with the Animal and
Plant Health Inspection Service, a part of USDA's marketing and regulatory
programs mission area.
Developing and commercializing new genetically engineered plant
varieties most often involves field testing under APHIS oversight, followed by
San
Protect environment
submission of a petition for determination of nonregulated status by the
agency.
APHIS grants nonregulated status to a new plant variety when it
determines that the new variety has no potential to pose a plant pest risk and
Bosed
is as safe to grow as any other variety of the same plant.
The amended regulations will allow a broader application of existing
simplified procedures for requests for movement or field testing of
genetically engineered plants. They will also streamline the determination of
nonregulated status for plant varieties that closely resemble other varieties
that have already been through the determination process. This will enable
APHIS, when appropriate, to extend the existing determination of nonregulated
status for new products that do not raise new risk issues.
For plants that are being evaluated in field tests, reporting
requirements have been made more consistent. For example, for trees and other
long lived plants field data reports will only need to be provided upon the
conclusion of the trial. However, applicants must apply to APHIS for yearly
renewal to ensure appropriate measures are taken when plants become
reproductively mature.
APHIS will also use appropriate guidelines to provide additional
information to developers of regulated articles and other interested persons
regarding procedures, methods, scientific principles, and other factors that
could be considered for various aspects of its regulations. The first
guidelines will provide information to help applicants on requests for
extension of a determination of nonregulated status.
Payne added that USDA has the responsibility to ensure that, in
releasing any bioengineered plant, no plant pest risk is presented. APHIS
- more -
8/7 it 1818
20-770-3034 VO-SIHEV
INVESTM 46616 May.
05/09/97
08:52
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LPA-MEDIA SVCS
003/003
- 2 -
reviewers focus on the biology, propagation, and cultivation of the plant.
The reviewers also consider the source of the engineered genes, the vector
used to transfer them, and the stability of the insertion.
The original final rule which was printed in the April 24, Federal
Register was retracted April 25, a month before it would have gone into
effect. This final rule supersedes the previous one issued.
For further information on the regulatory changes, contact John Payne,
director, biotechnology and scientific services, 4700 River Road, Unit 98,
Riverdale, Md. 20737-1237; (301) 734-7602. For technical information, contact
Michael schechtman, biotechnology and scientific services, plant protection
and quarantine, Unit 146, Riverdale, Md. 20737-1237, (301) 734-7601.
Notice of this action is scheduled for publication in the May 2 Federal
Register and becomes effective June 2.
NOTE: USDA news releases, program announcements, and media advisories are
available on the Internet. Access the APHIS Home Page by pointing your Web
browser to
http://www.aphis.usda.gov and clicking on "APHIS Press Releases." Also,
anyone with an e-mail address can sign up to receive APHIS prese releases
automatically. Send an e-mail message to
[email protected]
and leave the subject blank. In the message, type
subscribe press_releases
8/8 'd 8184 No.
VO-SIHPV
May. 9. 1997 11:23AM
Activities of the Animal and Plant Health Inspection Service
Blotechnology and Scientific Services (BSS) April 1997
301-734-7602 VOICE 301-734-3643 FAX
Field Testing of New
Petitions: Determination of Nonregulated Status
Agricultural Products
approved and pending: as of 3/31/97
Continues and Expands
Field testing of new agricultural products
92
continues its rapid pace of expansion by
approximately doubling each year. Since
93
1987 the Animal and Plant Health
24
Inspection Service (APHIS) has approved
Year
or acknowledged 2,745 field trials at 11.291
90
field sites. The notification option, which
96
simplifies regulatory requirements for
certain field trials involving particular types
$7
of modified crops, has been in effect since
1993 and now accounts for approximately
0
5
10
15
20
a
30
85% of all current field testing Since the
Number Approved/Panding
beginning of 1994. 2.086 field trials (at
Applicable
9.746 test sites) were approved or
REPending
acknowledged, of which 1,781 were
AITRIT
conducted under notification and 305 under
permit. Derivatives of 48 different plant
species have been field tested to date. with a
Field Releases* : Most Frequent Categories
wide variety of modifications (see right).
1987 to 1997 (3/31/97)
Com continues as the major crop being field
tested under our regulations. In the past 2
years we have seen the first field trials
Viral Resistant
involving Arabidopsis thaliana, barley.
Herbicide Tolerant
317 (10.6%)
broccoli. carrot, chicory, cranberry,
127 (27.5%)
creeping bentgrass, eggplant, gladiolus,
Insect Resistant
722 (24.2%)
grape, pea, pepper. raspberry, strawberry,
sugarcane, sweetgum. sweet potato,
Fungal Resistant
watermelon. and wheat.
124 (4,2%)
In an effort to expand public access and
Product Quality
Other
789 (26.2%)
awareness of the progress in the
209 (7.0%)
development of work with transgenic plants,
APHIS has made available on the Internet
Permits Issued and
Agrenome Properties
Marker Gener. Selective Markers,
information on both field testing and
Notifications Acknowledged
Resistant and Nerratode Resistent
commercialization of new varieties.
4/7/97
This information. which is updated daily
and provides direct public access to
information formerly available only upon
1. Insect-resistant com, Ciba Seeds,
written request, is proving useful both to
11. Male-sterile com, Plant Genetic
May 1995.
companies and to individual researchers
Systems (America). Inc.,
who wish to track the progress of
2. Herbicide-tolerant com. AgrEvo.
February 1996.
June 1995.
agricultural biotechnology. The World
12. Altered-ripening tomato, Agritope.
3. Insect-resistant cotton, Monsanto
Wide Web site can be accessed at
Inc., March 1996.
Agricultural Co., June 1995.
htp://www.aphis.usda.govtbbepibpi.
13. Colorado potato-beetle- resistant
4. Delayed-softening tomato, Zeneca
potato, Monsanto Agricultural Co.,
Plant Science/Petoseed Co., Inc.,
Some New Products No
May 1996.
June 1995.
14. Virus-resistant squash, Asgrow Seeds,
Longer Regulated
5. Herbicide-tolerant cotton, Monsanto
June 1996.
Over the past year, there has been a con-
Agricultural Co., July 1995.
15. Herbicide-tolerant soybean, AgrEvo.
tinuous flow of requests for determinations
6. Insect-resistant com, Monsanto
July 1996.
by APHIS that particular field-tested organ-
Agricultural Co., August 1995.
16. Virus-resistant papaya, Cornell
isms have no potential for plant pest risk
7. Altered-ripening tomato, Monsanto
University and The University of
and should no longer be regulated (see
Agricultural Co., September 1995.
Hawaii. September 1996.
right). These requests, from developers of
8. Herbicide-tolerant com, DeKalb
17. Insect-resistant com, DeKalb
new products produced through biotech-
Genetics Corp., December 1995.
Genetics Corp., March 1997.
nology, facilitate the entry of the products
9. Insect-resistant corn, Northrup King
into the marketplace. Seventeen new prod-
Co., January 1996.
10. Herbicide-tolerant cotton, DuPost
ucts in six crop plants were the subject of
such determinations in the past 23 months-
Agricultural Products, January 1996.
No. 8184 P. 4/8
VO-SIHOA
May. 9. 1997 11:23AM
Four types of products that have been
the field trial. and these documents have
have established a Permanent Tech-
approved merit particular mention here-
also been made available electronically.
nical Working Group on Biotechnology and
In April 1996 APHIS made available to
the Environment. There are also other
1. Virus-resistant squash. the first of
the public a regulatory assessment and
informal meetings with representatives of
which was approved in 1994. was the
granted a courtesy permit for the conrolled
the Commission of the European Union and
first crop considered for which there
field testing of a transgenic nematode in
key trading partners to discuss policy de-
are populations of intertreeding wild
Salem County, NJ after going through a
velopments on the commercialization of,
relatives in the major areas of squash
similar process. The nematode,
and trade in. new agricultural commodities.
cultivation in the United States. and
Heterorhabditis bacteriophora. is a native
Under the joint auspices of the OECD
with a trait that has the potential in
nonpathogenic organism widely distributed
Environment and Agriculture
theory to alter the fitness of the crop
across the United States. It was modified
Directorates, the United States has
plant or its wild relatives. The
with the addition of a gene encoding a
taken the lead in a project on the
analysis demonstrated that there was
fluorescent marker protein and another
Commercialization of Agricultural
no potential for increased weediness
encoding a heat-shock response protein.
Products Derived Through Modem
of either the crop or its relatives as a
Biotechnology. The aims of this proj-
result of cultivation in agriculture of
Regulatory and Policy
ecl, which was initiated in 1994, are to
the new squash variety.
Developments In Progress
assist member countries in their
oversight of these organisms,
2. Insect-resistant crops, of which a
We continually reexamine our regulations
specifically in their efforts to ensure
potato developed by Monsanto
to keep abreast of the latest scientific
safety. to make oversight policies more
Agricultural Company was the first
developments to remain responsive to the
transparent. and to facilitate trade. A
approved in March 1995. may have
demands of rapidly expanding technology
key area of work has been the
the potential to offer an alternative to
and to the public. In the interest of such
development of scientific consensus
the use of chemical insecticides.
flexibility and responsiveness, new
documents 00 specific topics relevant
regulations were proposed in the Federal
to the environmental biosafety of
3. The insect-resistant com developed by
Register 00 August 22, 1995, which, if
transgenic plants, such as the biology of
Ciba Seeds was the first new com
finalized, would
particular cTop plants and issues
variety that has been determined not to
Enable APHIS to extend an existing
associated with the introduction of
pose a potential plant pest risk. The
determination of nonregulated status to
particular traits into plants. One that
modification in the corn line may offer
additional organisms that resemble the
has been completed concerns the use of
the potential for control of European
organism for which the determination
coat protein genes from plant viruses to
com borer, which has not heretofore
was initially made
confer virus resistance on host plants.
been effectively managed. Com is the
Extend the notification system to enable
Regular meetings continue with Canada
leading crop in terms of economic
field testing under performance
and Mexico to address safety issues
importance in the United States.
standards of most crop plant species.
relevant to biotechnology-derived
4. Virus-resistant papaya, which was
The proposed rule also announces
commodities that are under regulatory
APHIS' intent to develop guidelines on
review or already approved in one of
approved in 1996. was the first new
product developed by academic
various topics relevant to our regulations to
our three nations, and to facilitate trade
researchers in collaboration with
developers of new varieties and to other
in these products.
USDA scientists.
interested persons. In addition. the pro-
APHIS continues to be an active
posed rule would lessen certain paperwork
participant in discussions by the
requirements for the research community
Conference of Parties (COP) to the
Transgenic Arthropods and
and for State agricultural officials. The
Convention on Biological Diversity.
Nematodes-First Field
comment period on the proposed rule closed
The COP, of which the United States is
Trials Approved
on October 23, 1995.
not a member. decided to negotiate a
In February 1996 APHIS granted 2 permit
binding protocol that may affect inter-
for the first limited field trial release of a
International Harmonization
national transfer of certain bio-
transgenic arthroped. Metaselulus
of Regulatory Approaches
technology products, and set up an ad
occidentalis (Acari: Phytoseiidae), in
hoc working group to develop it The
For the first time several new agricultural
United States is participating in those
Ajachua County, Florida. This organism. a
biotechnology products developed in the
negotiations, which commenced in July
transgenic predatory mite, may be
United States are entering the international
1996 in Aarhus, Denmark. The next
potentially useful for the control of spider
mite in strawberries and other crops. The
marketplace as produce and as bulk
meeting is to be held in May 1997 in
commodities.
Montreal. Canada. APHIS is working
particular transgenic organism was modified
only by the addition of marker DNA
A key effort we have undertaken is to
along with other Federal agencies to
ensure that these products can enter existing
ensure that appropriate policies are
sequences, which are not expressed and do
export markets without the imposition of
agreed upon to guarantee the safe
not alter any of its phenotypic
undue regulatory burdens. We are working
international use and development of
characteristics. Upon receipt of the
on several fronts to being about international
new products derived through
application. APHIS made it available to the
harmonization of regulatory approaches for
biotechnology.
public clectronically and established an
these products-
expert team for its review. An
Environmental Assessment and Finding of
Ongoing bilateral environmental
No Significant Impact was prepared in
consultations with the Commission of
support of the agency decision to authorize
the European Union continue and we
8/9
di
8184
VO-SIH¿V
11:24AM
Clinton Presidential Records
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scan such dividers. The title from the original document is
indicated below.
NBAC
Divider Title:
EXECUTIVE OFFICE OF THE PRESIDENT
OFFICE OF SCIENCE AND TECHNOLOGY POLICY
WASHINGTON, D.C. 20502
March 19, 1997
NBAC
MEMORANDUM FOR FRANKLIN D. RAINES
DIRECTOR
OFFICE OF MANAGEMENT AND BUDGET
FROM:
JOHN H. GIBBONS
SH
DIRECTOR
SUBJECT:
AMENDMENT TO EXECUTIVE ORDER 12975 - Extending the
Charter of the National Bioethics Advisory Commission (NBAC)
The purpose of this memorandum is to seek a two-year extension of the charter for the
National Bioethics Advisory Commission (NBAC). NBAC was established on October 3, 1995
by Executive Order 12975. As with other Federal advisory committees, the original charter
provides for a two-year term, expiring on October 3, 1997, unless extended. Due to the length of
time required for member selection and background reviews, the Commission did not meet until
October 4, 1996, a full year after its establishment. (E.O. 12975, draft amendment and NBAC
charter are attached.)
The President issued an initial charge to the Commission to consider protection of the
rights and welfare of human research subjects, and issues in the management and use of genetic
information. Then, on February 24, 1997, the President asked NBAC to take on an additional
charge: thorough review of the ethical and legal issues associated with possible use of cloning
technology to clone human embryos. The Commission's report on cloning is due at the end of
May.
I understand that Federal advisory committee charters are customarily reviewed and
extensions filed with the General Services Administration each September. However, in view of
the special circumstances in this case, it seems reasonable and appropriate to take action on
NBAC's charter immediately, thus facilitating the Commission's planning process for meeting
the President's requests.
You should be aware of a potential complication regarding NBAC's financial support.
The President delegated administrative responsibilities for NBAC under the Federal Advisory
Committee Act to the Secretary of the Department of Health and Human Services (HHS). For
the current fiscal year, HHS has explicit Congressional authority to seek funding for NBAC from
other Executive branch agencies and has done so, resulting in an arrangement that spreads the
estimated $1.6 million budget over seven agencies, with HHS paying one-half of the total. (A
list of the other agencies and their level of support is attached.) At a meeting on January 22, all
the agencies supported a two-year extension of the NBAC term, as proposed by HHS, and agreed
in principle to continue the current funding arrangement, subject to Congressional approval. The
Memo to Franklin D. Raines
March 19, 1997
Page two
President's FY 98 budget requests broad permission for multi-agency funding of Federal
advisory committees or alternatively, permission limited to NBAC. NBAC's charter is not
dependent on resolution of this issue since it leaves the matter of funding to HHS alone, subject
to the availability of appropriations.
Extending NBAC's charter will enable the Commission to respond to the President's
immediate request for advice and recommendations on the cloning of human beings, without
unduly constraining resources to address the President's two original concerns: protection of
human research subjects and proper use and management of genetic information, both important
issues in their own right. The issue of delays in naming the NBAC members and obtaining
support has been reported in the media as indicative of lack of attention from the Administration.
While this is not the case, prompt action on extending the Commission's term might be one way
to convey a more positive attitude and would support the Commission's efforts to provide
thoughtful, astute responses to the President's requests.
Please contact me or Rachel Levinson of my staff if you require further information.
Attachments
SENT BY:
10-27-95
:
3:36PM
SCI & TECH POLICY-
3014022071: 21 4
52063
Federal Register
Presidential Documents
Vol. 60. No. 193
Thursday. October S. 1995
Title 3-
Executive Order 12975 of October 3, 1995
The President
Protection of Human Research Subjects and Creation of
National Bioethics Advisory Commission
By the authority vested in me as President by the Constitution and the
laws of the United States of America. it is heroby ordered as follows:
Section 1. Review of Policies and Procedures. (a) Each executive branch
department and agency that conducts, supports, or regulates research involv-
ing human subjects shall promptly review the protections of the rights
and welfare of human research subjects that are afforded by the department's
or agency's existing policies and procedures. In conducting this review,
departments and agencies shall take account of the recommendations con
tained in the report of the Advisory. Committee on Human Radiation Experi-
ments.
(b) Within 120 days of the date of this order. each department and agency
that conducts, supports, or regulates research involving human subjects shall
report the results of the review required by paragraph (a) of this section
to the National Bioethics Advisory Commission, created pursuant to this
order. The report shall include an identification of measures that the depart-
ment or agency plans or proposes to implement to enhance human subject
protections. As set forth in section 5 of this order, the National Bioothics
Advisory Commission shall pursue. as its first priority. protection of the
rights and welfare of human research subjects.
(c) For purposes of this order. the terms "research" and "human subject"
shall have the meaning set forth in the 1991 Federal Policy for the Protection
of Human Subjects.
Sec. 2. Research Ethics. Each executive branch department and agency that
conducts. supports, or regulates research involving human subjects shall.
to the extent practicable and appropriate. develop professional and public
educational programs to enhance activities related to human subjects protec-
tion, provide forums for addressing ongoing and emerging issues in human
subjects research. and familiarize professionals engaged in nonfederally-fund
ed research with the ethical considerations associated with conducting re-
search involving human subjects. Where appropriate, such professional and
educational programs should be organized and conducted with the participa-
tion of medical schools. universities, scientific societies, voluntary health
organizations, or other interested parties.
Sec. 3. Establishment of. National Bioethics Advisory Commission. (a) There
is hereby established a National Bloethics Advisory Commission ("NBAC").
NBAC shall be composed of not more than 15 members to be appointed
by the President. NBAC shall be subject. to the Federal Advisory Committee
Act. as amended (5 U.S.C. App.).
(b) The President shall designate a Chairperson from among the members
of NBAC.
Soc. 4. Functions. (a) NBAC shall provide advice and make recommendations
to the National Science and Technology Council and to other appropriate
government ontities regarding the following matters:
(1) the appropriateness of departmental. agency. or other governmental
programs, policies. assignments, missione. guidolinos, and regulations as
they relate to bioethical issuos arising from research on human biology
and behavior: and
2064
Federal Rogister i Vol. GO, No. 193 / Thursday, October 5. 1995 / Presidential Documents
(2) applications, including the clinical applications, of that research.
(b) NBAC shall identify broad principles to govern the effical conduct
of research. citing specific projects only as illustrations for such principles.
(c) NBAC shall not be responsible for the review and approval of specific -
projects.
(d) In addition to responding to requests for advice and recommendations
from the National Science and Technology Council, NBAC also may accept
suggestions of issues for consideration from both the Congress and the
public. NBAC also may identify other bioethical issues for the purpose
of providing advice and recommendations, subject to the approval of the
National Science and Technology Council.
Sec. 5. Priorities. (a) As a first priority, NBAC shall direct its attention
to consideration of: protection of the rights and welfare of human research
subjects; and issues in the management and use of genetic information,
including but not limited to, human gene patenting.
(b) NBAC shall consider four criteria in establishing the other priorities
for its activities:
(1) the public health or public policy urgency of the bioethical issue:
(2) the relation of the bioethical issue to the goals for Federal investment
in science and technology:
(3) the absence of another entity able to deliberate appropriately on the
bioethical issue: and
(4) the extent of interest in the issue within the Federal Government.
Sec. 6. Administration. (a) The heads of executive departments and agencies
shall, to the extent permitted by law, provide NBAC with such information
as it may require for purposes of carrying out its functions.
(b) NBAC may conduct inquiries, hold hearings. and establish subcommittees,
as necessary. The Assistant to the President for Science and Technology
and the Secretary of Health and Human Services shall be notified upon
establishment of each subcommittee, and shall be provided information on
the name, membership (including chair). function, estimated duration, and
estimated frequency of meetings of the subcommittee,
(c) NBAC is authorized to conduct analyses and develop reports or other
materials. In order to augment the exportise present on NBAC. the Secretary
of Health and Human Services may contract för the services of nongovern-
mental consultants who may conduct analyses. prepare reports and back-
ground papers, or prepare other materials for consideration by NBAC, as
appropriate.
(d) Members of NBAC shall be compensated in accordance with Federal
law. Members of NBAC may be allowed travel expenses, including per
diem in lieu of subsistence. to the extent permitted by law for persons
serving intermittently in the government service (5 U.S.C. 5701-5707).
(e) To the extent permitted by law. and subject to the availability of appropria-
tions. the Department of Health and Human Services shall provide NBAC
with such funds as may be necessary for the performance of its functions.
The Secretary of Health and Human Services shall provide management
and support services to-NBAC.
Sec: 7. General Provisions. (a) Notwithstanding the provisions of any other
Executive order. the functions of the President under the Federal Advisory
Committee Act that are applicable to NBAC. except that of reporting annually
to the Congress. shall be performed by the Secretary of Health and Human
Servicus. in accordance with the guidelines and procedures established by
the Administrator of General Services.
(b) NBAC shall terminate two years from the date of this order unloss
extended prior to that date.
DCNS or
10
Federal Register / Vol. GO. No. 193 / Thursday, October 5, 1995 / Presidential Documents
52085
(c) This order is intended only to improve the internal management of
the executive branch and it is not intended to create any right, benefit.
trust, or responsibility. substantive or procedural, enforceable at law or
equity by a. party against the United States, its agencies, its officers, or
any person.
areriam Tennten
THE WHITE HOUSE,
[FR Doc. 05-24821
October 3, 1995.
Filed 10-3-95: 2:11 prul
Billing code 3185-01-1'
EXECUTIVE ORDER
AMENDING EXECUTIVE ORDER'NO. 12975
By the authority vested in me as President by the Constitution and the laws of the United
States of America, and in order to extend the term of the National Bioethics Advisory
Commission, it is hereby ordered that Section 7(b) of Executive Order No. 12975 is amended to
date." read, "NBAC shall terminate on October 3, 1999, unless extended by the President prior to that
WILLIAM J. CLINTON
NATIONAL BIOETHICS ADVISORY COMMISSION CHARTER
Purpose
The National Bioethics Advisory Commission will provide advice and make recommendations
to the National Science and Technology Council, other appropriate entities and the public, on
bioethical issues arising from research on human biology and behavior, and the applications,
including the clinical applications, of that research.
Authority
Executive Order 12975. This Commission is governed by the provisions of the Federal
Advisory Committee Act (FACA), Public Law 92-463, as amended (5 U.S.C. Appendix 2),
which sets forth standards for the formation of advisory committees, and implementing
regulations (41 C.F.R. § 101-6.10).
Functions
The National Bioethics Advisory Commission shall advise, consult with, and make
recommendations to the National Science and Technology Council, Federal agencies, and other
appropriate entities, and also make available to the public the Commission's advice and
recommendations. The Commission's purview includes the appropriateness of departmental,
agency, or other governmental programs, policies, assignments, missions, guidelines, and
regulations as they relate to bioethical issues arising from research on human biology and
behavior, and applications, including the clinical applications, of that research. The
Commission shall identify broad, overarching principles to govern the ethical conduct of
research, citing individual projects only as illustrations for such principles. The Commission
shall not be responsible for the review and approval of individual projects.
As a first priority, the Commission will direct its attention to consideration of:
A.
Protection of the rights and welfare of human research subjects; and
B.
Issues in the management and use of genetic information including but not limited to
human gene patenting.
In addition to responding to requests for advice and recommendations from the National Science
and Technology Council, the Commission also may accept suggestions for issues for
consideration from both the Congress and the public. The Commission also may identify other
bioethical issues for the purpose of providing advice and recommendations, subject to the
approval of the National Science and Technology Council. The Commission shall consider four
criteria in establishing priority for its activities:
A.
The public health or public policy urgency of the bioethical issue.
B.
The relation of the bioethical issue to the goals for Federal investment in science and
technology.
C.
The absence of another body able to deliberate fruitfully on the bioethical issue.
D.
The extent of interest in the issue across the government. (The Commission ordinarily
will not deliberate on a bioethical issue of interest to just one department or agency.)
Structure
The National Bioethics Advisory Commission shall consist of not more than 18 members
including the Chairperson. Appointments shall be made by the President, who shall select from
knowledgeable non-Government experts and community representatives with special
qualifications and competence to deal effectively with bioethical issues. At least one member
shall be selected from each of the following catégories of primary expertise: (i)
philosophy/theology; (ii) social/behavioral science; (iii) law; (iv) medicine/allied health
professions; and (v) biological research. At least three members shall be selected from the
general public, bringing to the Commission expertise other than that listed. The membership
shall be approximately evenly balanced between scientists and non-scientists. Close attention
will be given to equitable geographic distribution and to ethnic and gender representation.
Members shall be appointed for overlapping four-year terms. Initially, members will be
appointed for two-, three- or four-year terms. Terms of more than two years are contingent
upon renewal of the National Bioethics Advisory Commission by appropriate action prior to its
termination. The Chairperson shall be appointed by the President. The term of office for the
Chairperson shall be two years, renewable by appropriate action of the President.
If a vacancy occurs on the Commission, the President shall make an appointment to fulfill the
term. Any member appointed to fill a vacancy occurring prior to expiration of the term for
which his or her predecessor was appointed shall serve for the remainder of such term.
Members may serve after the expiration of their terms until their successors have taken office.
The heads of executive departments and agencies shall, to the extent permitted by law, provide
the Commission with such information as it may require for purposes of carrying out its
functions.
The Commission may conduct inquiries, hold hearings and establish subcommittees, as
necessary.
The Commission is authorized to solicit information from relevant human research subject
groups.
The Commission is authorized to conduct analyses and develop reports or other materials. In
order to augment the expertise present on the Commission, the Secretary of Health and Human
Services is also authorized to contract for the services of non-governmental consultants who
may conduct analyses, prepare reports and background papers or prepare other materials for
consideration by the Commission, as appropriate.
2
In order to avoid duplication of effort, the Commission is encouraged to review the
deliberations of other entities. The Commission may incorporate or otherwise use the results of
the deliberations of other entities as it deems appropriate.
The Assistant to the President for Science and Technology and the Secretary of Health and
Human Services shall be notified upon establishment of each subcommittee, and shall, be
provided information on the name; membership (including chair), function; estimated duration
of the subcommittee, and estimated frequency of meetings.
To the extent permitted by law, and subject to the availability of appropriations, the Department
of Health and Human Services (DHHS) shall provide NBAC with such funds as may be
necessary for the performance of its functions. Management and support services shall be
provided by the DHHS.
Meetings
Meetings of the Commission shall be held up to 10 times a year at the call of the Chairperson.
Meetings of the subcommittee(s) shall be convened as necessary. A Federal Government
official shall be present at all meetings.
Meetings shall be open to the public except as determined otherwise by the Assistant to the
President for Science and Technology and the Secretary of Health and Human Services.
Advance notice of all meetings shall be given to the public.
Meetings shall be conducted, and records of proceedings kept, as required by applicable laws
and Federal regulations.
Compensation
Members may be compensated at a rate not to exceed the maximum pay authorized by
5 U.S.C. 3109, plus per diem and travel expenses as in accordance with standard government
travel regulations.
Annual Cost Estimate
The estimated annual cost for operating the National Bioethics Advisory Commission is
$500,000.
Reports
Reports by the National Bioethics Advisory Commission on specific issues shall be submitted to
the National Science and Technology Council, the appropriate committees of Congress, and
other appropriate entities. The Commission may specifically identify the Federal department,
agency or other entity to which particular recommendations are directed and request a response
from the Federal department, agency or other entity within 180 days of publication of such
recommendation.
3
Executive summaries of each report of the Commission shall be promulgated in the Federal
Register. Such summaries shall specifically list the department, agency, or other entity to
which any recommendations are directed and the date by which such responses are expected.
An annual report shall be submitted to the National Science and Technology Council and the
appropriate committees of Congress. It shall contain, at a minimum, (i) the Commission's
function; (ii) a list of members and their business addresses; (iii) the dates and places-of
meetings; (iv) a summary of the Commission's activities during the year; (v) a summary of the
Commission's recommendations made during the year; and (vi) a summary of responses made
by departments, agencies, or other entities to the Commission's recommendations during the
year.
General Provisions
Notwithstanding the provisions of any other Executive Order, the functions of the President
under the Federal Advisory Committee Act that are applicable to the Commission, except that
of reporting annually to the Congress, shall be performed by the Secretary of Health and
Human Services, in accordance with the guidelines and procedures established by the
Administrator of General Services.
Termination Date
Unless extended by appropriate action prior to its expiration, this National Bioethics Advisory
Commission will terminate October 3, 1997.
Approved:
John John H. Gibbons Hilbaurn
Date 26 July 1996
Assistant to the President for
Science and Technology
NBAC Funding Request - FY 97
Agency
Amount ($$ in 000's)
DHHS
800
DOD
200
DOE
150
VA
150
USDA
125
NASA
100
NSF
75
ROSTER OF NBAC MEMBERS
Chair
R. Alta Charo, J.D.
Harold T. Shapiro, Ph.D.
Professor of Law
President
University of Wisconsin
Princeton University
6108 Law Bldg., 975 Bascom Mall
One Nassau Hall
Madison, WI 53706
Princeton, NJ 08544-0015
(July 19, 1996 - July 18, 2000)
(July 19, 1996 - July 18, 2000)
James Childress, Ph.D.
Patricia Backlar
Department of Religious Studies
Senior Scholar
University of Virginia
Center for Ethics in Health Care
Cocke Hall, Rm. 101
Oregon Health Sciences University
Charlottesville, VA 22903
Portland, OR 97207
(July 19, 1996 - July 18, 1999)
(July 19, 1996 - July 18, 1998)
David R. Cox, M.D., Ph.D.
Arturo Brito, M.D.
Professor of Genetics and Pediatrics
L
Assistant Professor of Clinical Pediatrics
Stanford University School of Medicine
University of Miami School of Medicine
Department of Genetics, M-336
1601 NW 12th Avenue
Stanford, CA 94305
Miami, FL 33136
(July 19, 1996 - July 18, 1999)
(July 19, 1996 - July 18, 1999)
Rhetaugh Graves Dumas, Ph.D., R.N.
Alexander M. Capron, LL.B.
Vice Provost for Health Affairs
A.A
Co-Director
The University of Michigan
Pacific Center for Health Policy and Ethics
3088 Fleming Administration Building
Univ of Southern California Law Center
Ann Arbor, MI 48109-1340
699 Exposition
(September 16, 1996 - September 15, 1999)
Los Angeles, CA 90089-0071
(July 19, 1996 - July 18, 2000)
Ezekiel J. Emanuel, M.D., Ph.D.
Associate Professor of Medicine
Eric J. Cassell, M.D.
and Social Medicine
Professor of Public Health
Dana-Farber Cancer Institute
Cornell Medical College
44 Binney Street
1550 York Avenue
Boston, MA 02115
New York, NY 10028
(July 19, 1996 - July 18, 1998)
(July 19, 1996-July 18, 1998)
Laurie M. Flynn
Bernard Lo, M.D.
ASIAN-
Executive Director
Director
AMERICAN
National Alliance for the
Program in Medical Ethics
Mentally III
University of California, San Francisco
200 N. Glebe Road, Suite 1015
521 Parnassus Avenue, Rm. C126
Arlington, VA 22203
San Francisco, CA 94143-0903
(July 19, 1996 - July 18, 2000)
(July 19, 1996 - July 18, 2000)
Carol W. Greider, Ph.D.
Lawrence H. Miike, M.D., J.D. HAWAII AN
Senior Staff Scientist
Director
Cold Spring Harbor Laboratory
State Department of Health
1 Bungtown Road
1250 Punchbowl Street
Cold Spring Harbor, NY 11724
Honolulu, HI 96813
(October 29, 1996 - October 28, 1998)
(July 19, 1996 - July 18, 1998)
Steven H. Holtzman
Thomas H. Murray, Ph.D.
Chief Business Officer
Director, Center for Biomedical Ethics
Millenium Pharmaceuticals Inc.
School of Medicine
640 Memorial Drive
Case Western Reserve University
Cambridge, MA 02139
10900 Euclid Avenue
(July 19, 1996 - July 18, 1999)
Cleveland, OH 44106-4976
(July 19, 1996 - July 18, 1999)
Bette O. Kramer
President
Diane Scott-Jones, Ph.D.
A-A
Richmond Bioethics Consortium
Professor
1803 Hanover Avenue
Department of Psychology
Richmond, VA 23220
Temple University
(September 16, 1996 - September 15, 1998)
564 Weiss Hall
1701 North 13th Street
Philadelphia, Pa 19122-6085
(July 19, 1996 - July 18, 2000)
12/17/96
Clinton Presidential Records
Digital Records Marker
This is not a presidential record. This is used as an administrative
marker by the William J. Clinton Presidential Library Staff.
This marker identifies the place of a tabbed divider. Given our
digitization capabilities, we are sometimes unable to adequately
scan such dividers. The title from the original document is
indicated below.
Building Public Trust
Divider Title:
CANADA
RYN CALINO OF
ATES OF
ACTIONS TO RESPOND TO THE
REPORT OF THE ADVISORY COMMITTEE
ON HUMAN RADIATION EXPERIMENTS
HEALTH
INTERNATION FREE)
STATE
STATES
OF
United States Government
Human Radiation Interagency Working-Group
THE WHITE HOUSE
WASHINGTON
In January 1994, after accounts of Cold War-era experiments
involving the effects of radiation on humans came to light, I established
an independent Advisory Committee on Human Radiation Experiments to
investigate these reports. I asked the Committee to determine the truth
about this dark chapter in our nation's history.
After taking extensive testimony and conducting numerous public
hearings, the Advisory Committee issued its report in October, 1995. The
Committee's report included recommendations to make the record of these
experiments open to the public, improve ethics in human research today,
and right the wrongs of the past inflicted on unknowing citizens. In my
remarks when I accepted the report, I promised that it would not be left
on the shelf to gather dust. I made a commitment that we would learn from
the lessons that the Committee's report offered and use it as a road map
to lead us to better choices in the future.
This document -- my Administration's response to the Advisory
Committee's report -- is a milestone in meeting that commitment. We
have actively worked to respond to the important recommendations made by
he Advisory Committee through a special interagency working group. This
oup includes representatives from the Executive Office of the President,
the Departments of Energy, Defense, Health and Human Services, Justice,
Veterans Affairs, the National Aeronautics and Space Administration, and
the Central Intelligence Agency. The Environmental Protection Agency has
also joined the effort. This report reflects the joint progress of these
agencies to address the Advisory Committee's recommendations.
My Administration has made significant achievements in opening
government and making information more easily available to the citizens
to whom it belongs. Agencies have also improved the protections in place
for subjects of future human research. Finally, the Federal government is
providing redress to those who have suffered from radiation experiments,
as recommended by the Advisory Committee.
I emphasize that this document is by no means the end of the
journey. Much work remains to be done. I am confident that all of
us -- the eminent committee that produced the original report, the
Federal officials who worked SO hard to support the Committee's efforts
and now are implementing its recommendations, and most importantly, the
citizens of this great country from whose experiences we have learned
SO much can together help ensure a better world for our children.
My thanks to all of you for a job well done, I pledge my strong
support for your continued efforts.
Rin Chinton
Executive Summary
"Our greatness is measured not only in how we
do right but also [in]
how we act when we know we've done the wrong thing; how we confront
our mistakes, make our apologies, and take action."
-President Clinton
October 3, 1995
In January 1994, President Clinton established the Advisory
Committee on Human Radiation Experiments (ACHRE) to examine
reports that the government had funded and conducted unethical
human radiation experiments and releases of radiation during the
Cold War. The President directed ACHRE to uncover the truth,
recommend steps to right past wrongs, and propose ways to prevent
unethical human subjects research from occurring in the future.
The Committee published its findings and recommendations in
The Administration
October 1995.
has adopted most of
ACHRE's recommen-
This report presents the Administration's actions to respond to
dations and has
ACHRE's findings and recommendations. The Committee found that
acted throughout
the government had conducted several thousand human radiation
the government to
experiments from 1944 to 1975. Although the majority of the
implement them.
experiments advanced biomedical science and were unlikely to have
caused harm, some were conducted unethically. ACHRE made 18
recommendations to improve openness in government, protect
human subjects in the future, and redress past wrongs. The Admin-
istration has adopted most of ACHRE's recommendations and has
acted throughout the government to implement them.
Opening the Record
ACHRE recommended that the government take a number of steps
to organize the historical records of human radiation experiments
and to give the public access to these records. ACHRE identified the
National Archives as the appropriate repository for documents. The
Committee also recommended an independent review of the CIA's
recordkeeping system and all of its documents related to human
radiation experiments.
V
Building Public Trust: Actions to Respond to the Advisory Committee on Human Radiation Experiments
Key Actions
The Administration has invested heavily in making documents
accessible. ACHRE transferred more than 1 million pages of
documents to the National Archives. The Administration has
made 300,000 fully searchable pages of documents available on
the Internet, and will add an additional 200,000 pages shortly.
The Departments of Energy and Defense have published
document search guides.
The Administration
has invested heavily
The President signed Executive Order 12958 directing Federal
in making documents
agencies to review and declassify thousands of documents,
accessible.
including documents on radiation experiments.
The National Archives and Records Administration is conducting
an independent review of the Central Intelligence Agency's
(CIA's) recordkeeping system and the CIA's Inspector General
reviewed and reported on the CIA's human experiments.
Protecting Human Subjects in the Future
The Advisory Committee recommended steps to strengthen protec-
tions for human subjects and ensure the government does not
repeat past mistakes.
Key Actions
President Clinton is issuing a directive to strengthen protections
for subjects of classified (secret) research. Agencies will propose
A subcommittee of
new rules to eliminate waiver of informed consent; disclose the
National Bioethics
identity of the sponsoring agency; ensure a more independent
Advisory Committee
review process; and require permanent records. Agencies will
will address certain
also report annually on the number of classified human research
projects and the number of human subjects involved in each
broad questions raised
project.
by ACHRE, including
how to strengthen
President Clinton established the National Bioethics Advisory
Institutional Review
Committee (NBAC) to examine bioethical issues, including
Boards-the local
human research issues. A subcommittee of NBAC will address
ethics panels for
certain broad questions raised by ACHRE, including how to
federally sponsored
strengthen Institutional Review Boards (IRBs)-the local ethics
research.
panels for federally sponsored research.
President Clinton directed agencies to develop plans to improve
oversight of ethics rules. NBAC will review these plans in the
coming months.
vi
Executive Summary
Agencies have undertaken nationwide education efforts to raise
the profile of ethical considerations, and are funding research to
improve our understanding of ethical issues.
Righting Past Wrongs
The Advisory Committee recommended, among other things, that
the government apologize to all subjects, compensate certain sub-
jects, and consider modifying the Radiation Exposure Compensation
Act, and its regulations, to compensate additional uranium miners.
Key Actions
The President apologized to all subjects on behalf of the govern-
ment; former Energy Secretary Hazel O'Leary made apologies in
certain individual cases.
ACHRE recommended that the government compensate the
families of the 18 subjects of the plutonium injection experi-
The Federal govern-
ments. The government has settled compensation claims with
ment has settled the
the 16 families who have come forward. ACHRE and the govern-
compensation claims
ment have not been able to identify participants in additional
experiments that ACHRE included in its recommendation for
of the 16 families of
compensation.
plutonium injection
subjects who have
The Administration will propose legislative and regulatory
come forward.
changes to the Radiation Exposure Compensation Act to
incorporate the latest science and better compensate affected
uranium miners.
The Administration will propose legislation to make veterans
treated with nasopharyngeal radiation eligible for health screen-
ing under the Department of Veterans Affairs' Ionizing Radiation
Program.
The actions and policies described in this report will help bring
justice to those harmed by the mistakes of the Cold War, and pre-
vent the recurrence of past wrongs. The report presents those
actions that are completed or underway. The Administration will
continue to take steps to open the government's records, raise
ethical standards, and right the wrongs of the past.
vii
Building Public Trust: Actions to Respond to the Advisory Committee on Human Radiation Experiments
ACHRE Findings and Recommendations on Protecting
Human Subjects in the Future
Based on its review of current human subject protections, the
Advisory Committee found, among other things, that
[H]uman research involving radioisotopes is currently
subjected to more safeguards and levels of review
than most other areas of research involving human
subjects. The Advisory Committee further finds that
there are no apparent differences between the
Responsibility for
treatment of human subjects of radiation research
ethical conduct of
and human subjects of other biomedical research.
research begins with
(Finding 20)
researchers and
extends to their
[T]oday [T] research involving human subjects sponsored
institutions, and the
by the government may be classified and conducted
Institutional Review
in secret, but it must comply with the provisions of
Boards (IRBs).
the Common Rule. (Finding 21)
[I]n comparison with the practices and policies of
the 1940s and 1950s, there have been significant
advances in the protection of the rights and interests
of human subjects of biomedical research. However,
we also find that there is evidence of serious defi-
ciencies in some parts of the current system for the
protection of the rights and interests of human
subjects. (Finding 22)
ACHRE Recommendation on the Centrality of Ethics
ACHRE recommended that active efforts on a national scale be made
to ensure that human subjects researchers fully understand the
ethical implications and responsibilities of their work, and the cen-
trality of ethical decisions. (Recommendation 9)
Response
Responsibility for the ethical conduct of research begins with
researchers and extends to their institutions and the Institutional
Review Boards (IRBs). The Administration has multiple efforts
underway to reach, educate, oversee, and hold accountable each
layer of the research system. The Administration is also taking steps
to promote understanding of, and consensus about, ethical issues.
10
Part 2: Protecting Future Human Subjects
National Bioethics Advisory Commission
The National Bioethics Advisory Commission (NBAC), a national
deliberative body of private citizens, was established by the
President to provide guidance to all Federal agencies on the ethical
conduct of human behavioral and clinical research, and the applica-
tions of that research. NBAC was established, in part, to respond to
The Executive Order
ACHRE, and the Administration expects NBAC will choose to ad-
establishing NBAC,
dress the key issues identified in ACHRE's recommendations. NBAC
required each agency
will not be able to review all issues raised by ACHRE. The Adminis-
to review its current
tration has been careful to ensure that issues not taken up by NBAC
human subjects re-
will be addressed elsewhere.
search in light of the
Advisory Committee
As a first priority, NBAC will seek to improve protection of the
recommendations and
rights and welfare of human research subjects. The Executive Order
report the results to
establishing NBAC, required each agency to review its current
NBAC.
human subjects research in light of the Advisory Committee recom-
mendations and report the results to NBAC. NBAC is currently
reviewing these documents. Appendix C details specific activities
currently being carried out by the agencies as a result of their
reviews.
NBAC's meetings are public and provide a forum for dialogue on
ethics issues. NBAC has heard presentations on issues related to
genetic research, including cloning, as well as the broader area of
human subjects research. Members of Congress, Congressional staff,
and representatives from diverse organizations including the Task
Force on Radiation and Human Rights, the College of American
Pathologists, the Biotechnology Industry Organization, and Citizens
for Responsible Care in Psychiatry and Research testified on ethics
issues and on NBAC's mission. Further information can be obtained
ACHRE's report made
from the NBAC Web Site (www.nih.gov/nbac/nbac.htm)
clear that a key to
preventing the
Education
repetition of past
ACHRE's report made clear that a key to preventing the repetition of
mistakes is thorough
past mistakes is thorough and continuing education about ethics
and continuing
and how they apply to current human subjects research. The Ad-
education about
ministration is responding to ACHRE's specific recommendations by
ethics and how they
co-sponsoring educational programs with external groups such as
apply to current
medical schools, universities, and scientific societies. The goals of
human subjects
these educational efforts are to strengthen human subjects protec-
research.
tion, to provide a forum for addressing ongoing as well as emerging
issues in human subjects research, and to familiarize professionals
engaged in non-federally funded human subjects research with
relevant ethical considerations.
Part of the ongoing educational process is a reinforcement of the
importance of Institutional Review Boards (IRBs) at institutions
conducting federally funded research. These IRBs are local groups
11
Building Public Trust: Actions to Respond to the Advisory Committee on Human Radiation Experiments
whose membership and responsibilities are regulated by the Federal
government. They are responsible for reviewing and approving the
ethical content of all proposed human subjects research projects.
IRBs are a linchpin in the protection of human subjects, and their
credibility and effectiveness depend on adequate awareness of basic
ethical topics.
Similarly, educational programs are also being targeted at govern-
ment-regulated research that is not government-funded (e.g., FDA-
regulated research sponsored by the pharmaceutical industry). In
September of 1996, the FDA sponsored its first nationwide confer-
ence on human subjects protection.
Government employees who have responsibility for supporting or
overseeing human subjects research are also targeted for educa-
tional programs. Thus, Federal agencies are implementing training
programs to educate senior level officials on regulations and policies
governing this research. For example, NASA is working with inter-
national research partners to develop common ethical principles
that ensure the protection of human subjects. DOE educational
efforts target laboratory staff, field office personnel, and program
officials.
Despite the vigor with
which all parties
Information Gathering
embrace the informed
consent process, it is
ACHRE's report highlighted the limited state of knowledge regard-
not well understood.
ing some key issues in human subjects research. Most importantly,
NBAC will be reviewing and evaluating the IRB process.
In addition, Departments have pooled resources to sponsor research
on the informed consent process. The informed consent process is
intended to help each potential research subject decide whether to
participate in research by providing advance information about the
research. Information includes a description of the nature of the
research, the subject's role and potential risks, and the subject's
rights and responsibilities. Despite the vigor with which all parties
embrace the informed consent process, it is not well understood.
Much of the Advisory Committee's commentary on current human
subjects research was centered on informed consent. The National
Institutes of Health (NIH), VA, and DOE are committed to support-
ing research that will more fully illuminate the informed consent
process. A Request for Applications (RFA) to conduct research on
this issue was published in the fall of 1996, and Fiscal Year 1997
monies are earmarked to support this RFA.
12
Part 2: Protecting Future Human Subjects
ACHRE Recommendation on Institutional Review Boards
ACHRE recommended specific changes to IRBs in five critical areas
(Recommendation 10):
(1) mechanisms to ensure a stronger focus on studies that pose more
than minimal risk to subjects;
(2) better means of explaining to potential subjects the distinction
between research and treatment, the realistic likelihood of
medical benefit to the subject from participation, and the
potential for discomfort and pain;
(3) ensuring that potential subjects fully understand the sponsors and
purposes of the research;
The Administration
(4) ensuring that potential subjects fully understand the financial
anticipates specific
implications of participation; and
recommendations
(5) recognition that the IRBs must decide if the quality of the science
from NBAC regarding
justifies the risk to the subjects.
reform of IRBs, includ-
ing recommendations
Response
that address ACHRE's
concerns.
The Administration agrees that there are indications that the IRB
system is not always adequate to ensure protection of human
subjects. NBAC has undertaken to review the current IRB system
and intends to finish that project within a year. The Administration
anticipates specific recommendations from NBAC regarding reform
of IRBs, including recommendations that address ACHRE's con-
cerns.
In the interim, agencies are informing IRBs of ACHRE's recommen-
dations and are working to improve IRBs.
The Office for Protection from Research Risks (OPRR), part of NIH,
is undertaking a national effort to educate the research community
about ACHRE's recommendations. OPRR and FDA support an
annual public meeting for individuals interested in the governance
of human subjects research. In addition, OPRR, in cooperation with
FDA and local academic institutions, has held discussions of the
recommendations at national workshops in Atlanta, Oklahoma City,
Honolulu, Peoria, Houston, and San Diego.
OPRR and the FDA make extensive use of public meetings, forums,
hearings, and electronic media to address evolving issues on human
subject protection. OPRR and FDA also regularly mail information
directly to IRBs and other interested parties. FDA seeks public input
through the Federal Register and by mailing proposals to the IRB
and clinical investigator communities. In October 1995, FDA issued
13
To
See opposite poge
It might be a good time to develop an Administration on the Glenn bill (S. 193) with the thought
of announcing support, if that is our conclusion. The major element of the bill is to extend
protection to human subjects of research conducted outside PHS or FDA regs. Criminal
penalties are authorized for violation of the Act. A relatively minor element of the bill is to
elevate the status of the Office for Protection from Research Risks out of NIH and place it in the
Office of the Secretary, DHHS.
As part of its deliberations on the adequacy of current protections for human subjects, NBAC is
considering adopting a resolution that would have the same effect as the Glenn bill.
Building Public Trust: Actions to Respond to the Advisory Committee on Human Radiation Experiments
Response
The Administration agrees that extraordinary steps are needed to
protect military personnel, and DOD is implementing ACHRE's
recommendations. Among other steps, DOD is revising directives
and Military Department regulations, and incorporating needed
training into courses for commanders, senior leadership, and those
involved in human subjects research. In the summer of 1997, DOD
will publish a revised human subjects protection directive that
includes policy changes recommended by the Advisory Committee.
For example, to avoid undue command influence, the new policy
will preclude officers and noncommissioned officers from playing a
role in selecting volunteers for military tests. (See Appendix C for
more details).
In the summer of
1997, DOD will
ACHRE Findings and Recommendation on the Federal
publish a revised
Oversight of Research
human subjects
protection directive
ACHRE found that oversight of human subjects research is limited and
that includes policy
is constrained by practical considerations. ACHRE found that the
changes recommended
"current mechanisms for oversight
do not provide a sufficient
by the Advisory
basis for ensuring that the current system is working properly."
Committee.
ACHRE found that sanctions may be inadequate for violations of
human subjects research protections. For example failure to obtain
consent from subjects (who are not physically injured) is generally
punishable only by the withdrawal of research funding.
ACHRE also found that "there is a need to assess the level of research
performed outside [the Common Rule] and to consider action to
ensure that all subjects are afforded the protections it offers."
ACHRE recommended the improvement of three parts of the current
Federal system for human research subject protection: oversight of the
research process; sanctions for violations of human subjects protec-
tions; and protections for subjects of non-federally funded research.
(Recommendation 13)
Response
The Administration agrees that there are important gaps in the
current system of human subjects protection, and has identified, in
testimony before Congress, examples of research that does not fall
within the ambit of Federal protection. Congress has proposed the
Human Research Subject Protection Act of 1997 (S. 193) to ensure
that all human subjects are adequately protected The Administra-
7
16
Part 2: Protecting Future Human Subjects
tion believes that Congress is also the appropriate place to consider
whether additional civil or criminal sanctions for the violation of
human subject protections are necessary and desirable. (Sanctions,
including criminal liability, apply to investigators conducting FDA-
regulated research who violate FDA regulations protecting human
The Administration
subjects.) Any legislation would need to protect research subjects
and avoid deterring needed research.
expects that NBAC will
recommend additional
In addition to exploring legislation, Federal agencies are undertak-
actions to improve
ing specific activities to strengthen oversight, some of which are
oversight of Federal
described in Appendix C. The Administration expects that NBAC
research, and will
will recommend additional actions to improve oversight of Federal
identify the highest
research, and will identify the highest priority steps.
priority steps.
ACHRE Findings and Recommendation on the
Compensation of Subjects in the Future
ACHRE found that the Federal government lacks a "policy or guide for
a fair system of compensation of research subjects."
ACHRE recommended that the government resolve the longstanding
issue of whether and how all persons injured in the future from
federally funded human subjects research should be compensated.
ACHRE recommended that the Federal government consider a system
of compensation for research subjects who suffer physical injury or
dignitary harm as a result of federally funded research.
(Recommendation 14)
Response
In the absence of a finding that a significant number of modern
research subjects are unfairly denied compensation, the Administra-
tion is not prepared to propose a system outside the existing net-
work of Federal and state liability and insurance systems.
The Administration does, however, view the debate over the extent
and effectiveness of our current human subject protections to
encompass this issue. The Administration would be open to consid-
ering any recommendations from NBAC or legislation from Congress
that seek to address this issue.
The desire to spread the cost of research injury is a reason to
consider a compensation scheme. The current tort system, though
imperfect, provides one mechanism to seek compensation for
injuries that arise from research. In addition, the tort system
17
APPENDIX A
REMARKS BY PRESIDENT WILLIAM J. CLINTON IN
ACCEPTANCE OF HUMAN RADIATION FINAL REPORT
October 3, 1995
Old Executive Office Building
Let me begin with a simple thank you to everyone who participated
in this extraordinary project and to everyone who supported them.
I want to thank Secretary O'Leary for her extraordinary devotion to
this cause. And you heard in her remarks basically the way that she
views this. It's a part of her ongoing commitment to finish the end
of the Cold War. And perhaps no Energy Secretary has ever done as
much as she has to be an advocate, whether it is for continued
reforms within the Energy Department or her outspoken endorse-
ment of the strongest possible commitment on the part of the
United States to a Comprehensive Test Ban Treaty, which I believe
we will achieve next year in no small measure thanks to the sup-
port of the Secretary of Energy.
And, of course, I want to thank Dr. Ruth Faden for her extraordinary
commitment of about a year and a half of her life to this unusual
but important task.
And all of you who served on the committee-I remember the first
time we put this committee together. I do thank you so much for
the work you have done.
I saw this committee as an indispensable part of our effort to restore
the confidence of the American people in the integrity of their
government. All of these political reform issues to me are inte-
grated. When I became the President, I realized we had great new
economic challenges, we had profound social problems, that a lot of
these things had to be done by an energized American citizenry, but
that our national government had a role to play in moving our
country through this period of transition. And in order to do it, we
needed to increase the capacity of the government to do it through
political reform, but we also needed, as much as anything else, to
increase the confidence of the American people that, at the very
least, they could trust the United States Government to tell the truth
and to do the right things.
A-1
Building Public Trust: Actions to Respond to the Advisory Committee on Human Radiation Experiments
So you have to understand that, for me, one reason this is so impor-
tant is that I see it as part of our ongoing effort to give this govern-
ment back to the American people-Senator Glenn's long effort to
get Congress to apply to itself the same laws it imposes on the
private sector-the restrictions that I imposed on members of my
administration in high positions for lobbying for foreign govern-
ments; and when the lobby bill failed in the Congress, I just im-
posed it by executive order on members of the Executive Branch.
All these efforts at political reform, it seems to me, are important.
But none of these efforts can succeed unless people believe that they
can rely on their government to tell them the truth and to do the
right thing. We have declassified thousands of government docu-
ments, files from second world war, the Cold War, President
Kennedy's assassination. These actions are not only consistent with
our national security, they are essential to advance our values.
So, to me, that's what this is all about. And to all those who repre-
sent the families who have been involved in these incidents, let me
say to you, I hope you feel that your government has kept its com-
mitment to the American people to tell the truth and to do the right
thing.
We discovered soon after I entered office that with the specter of an
atomic war looming like Armageddon far nearer than it does today,
the United States government actually did carry out on our citizens
experiments involving radiation. That's when I ordered the creation
of this committee. Dr. Faden and the others did a superb job. They
enlisted many of our nation's most significant and important medi-
cal and scientific ethicists. They had to determine first whether
experiments conducted or sponsored by our government between
1944 and 1974 met the ethical and scientific standards of that time
and of our time. And then they had to see to it that our research
today lives up to nothing less than our highest values and our most
deeply-held beliefs.
From the beginning, it was obvious to me that this energetic com-
mittee was prepared to do its part. We declassified thousands of
pages of documents. We gave committee members the keys
to the government's doors, file cabinets and safes. For the last year
and a half, the only thing that stood between them and the truth
were all the late nights and hard work they had to put in.
This report I received today is a monumental document-in more
ways than one. But it is a very, very important piece of America's
history, and it will shape America's future in ways that will make
us a more honorable, more successful and more ethical country.
A-2
Appendix A
What this committee learned I would like to review today with a
little more detail than Dr. Faden said, because I think it must be
engraved on our national memory. Thousands of government-
sponsored experiments did take place at hospitals, universities, and
military bases around our nation. The goal was to understand the
effects of radiation exposure on the human body.
While most of the tests were ethical by any standards, some were
unethical, not only by today's standards, but by the standards of the
time in which they were conducted. They failed both the test of our
national values and the test of humanity.
In one experiment, scientists injected plutonium into 18 patients
without their knowledge. In another, doctors exposed indigent
cancer patients to excessive doses of radiation, a treatment from
which it is virtually impossible that they could ever benefit.
The report also demonstrates that these and other experiments were
carried out on precisely those citizens who count most on the
government for its help-the destitute and the gravely ill. But the
dispossessed were not alone. Members of the military-precisely
those on whom we and our government count most-they were
also test subjects.
Informed consent means your doctor tells you the risk of the treat-
ment you are about to undergo. In too many cases, informed con-
sent was withheld. Americans were kept in the dark about the
effects of what was being done to them. The deception extended
beyond the test subjects themselves to encompass their families and
the American people as a whole, for these experiments were kept
secret. And they were shrouded not for a compelling reason of
national security, but for the simple fear of embarrassment, and that
was wrong.
Those who led the government when these decisions were made are
no longer here to take responsibility for what they did. They are not
here to apologize to the survivors, the family members or the
communities who's lives were darkened by the shadow of the atom
and these choices.
So today, on behalf of another generation of American leaders and
another generation of American citizens, the United States of
America offers a sincere apology to those of our citizens who were
subjected to these experiments, to their families, and to their com-
munities.
A-3
Building Public Trust: Actions to Respond to the Advisory Committee on Human Radiation Experiments
When the government does wrong, we have a moral responsibility
to admit it. The duty we owe to one another to tell the truth and to
protect our fellow citizens from excesses like these is one we can
never walk away from. Our government failed in that duty, and it
offers an apology to the survivors and their families and to all the
American people who must-who must be able to rely upon the
Untied States to keep its word, to tell the truth, and to do the right
thing.
We know there are moments when words alone are not enough.
That's why I am instructing my Cabinet to use and build on these
recommendations, to devise promptly a system of relief, including
compensation, that meets the standards of justice and conscience.
When called for, we will work with Congress to serve the best
needs of those who were harmed. Make no mistake, as the commit-
tee report says, there are circumstances where compensation is
appropriate as a matter of ethics and principle. I am committed to
seeing to it that the United States of America lives up to its responsi-
bility.
Our greatness is measured not only in how we so frequently do
right, but also how we act when we know we've done the wrong
thing; how we confront our mistakes, make our apologies, and
take action.
That's why this morning, I signed an executive order instructing
every arm and agency of our government that conducts, supports,
or regulates research involving human beings to review immedi-
ately their procedures, in light of the recommendations of this
report, and the best knowledge and standards available today, and
to report back to me by Christmas.
I have also created a Bioethics Advisory Commission to supervise
the process, to watch over all such research, and to see to it that
never again do we stray from the basic values of protecting
our people and being straight with them.
The report I received today will not be left on a shelf to gather dust.
Every one of its pages offers a lesson, and every lesson will be
learned from these good people who put a year and a half of their
lives into the effort to set America straight.
Medical and scientific progress depends upon learning about
people's responses to new medicines, to new cutting-edge treat-
ments. Without this kind of research, our children would still be
A-4
Appendix A
dying from polio and other killers. Without responsible radiation
research, we wouldn't be making the progress we are in the war on
cancer. We have to continue to research, but there is a right way
and a wrong way to do it.
There are local citizens' review boards, there are regulations that
establish proper informed consent and ensure that experiments are
conducted ethically. But in overseeing this necessary research, we
must never relax our vigilance.
The breathtaking advances in science and technology demand that
we always keep our ethical watchlight burning. No matter how
rapid the pace of change, it can never outrun our core convictions
that have stood us so well as a nation for more than 200 years now,
through many different scientific revolutions.
I believe we will meet the test of our times-that as science and
technology evolve, our ethical conscience will grow, not shrink.
Informed consent, community right-to-know, our entire battery of
essential human protections-all these grew up in response to the
health and humanitarian crises of this 20th century. They are proof
that we are equal to our challenges.
Science is not ever simply objective. It emerges from the crucible of
historical circumstances and personal experience. Times of crisis
and fear can call forth bad science, even science we know in retro-
spect to be unethical. Let us remember the difficult years chronicled
in this report, and think about how good people could have done
things that we know were wrong.
Let these pages serve as an internal reminder to hold humility and
moral accountability in higher esteem than we do the latest devel-
opment in technology. Let us remember, too, that cynicism about
government has roots in historical circumstances. Because of
stonewallings and evasions in the past, times when a family mem-
ber or a neighbor suffered an injustice and had nowhere to turn and
couldn't even get the facts, some Americans lost faith in the prom-
ise of our democracy. Government was very powerful, but very far
away and not trusted to be ethical.
So today, by making ourselves accountable for the sins of the past, I
hope more than anything else, we are laying the foundation stone
for a new era. Good people, like these members of Congress who
have labored on this issue for a long time, and have devoted their
careers to trying to do the right thing, and having people justifiably
feel confidence in the work of their representatives. They will
continue to work to see that we implement these recommendations.
A-5
Building Public Trust: Actions to Respond to the Advisory Committee on Human Radiation Experiments
And under our watch, we will no longer hide the truth from our
citizens. We will act as if all that we do will see the light of day.
Nothing that happens in Washington will ever be more important in
anyone's life affected by these experiments, perhaps, than these
reports we issue today. But all of us as Americans will be better off
because of the larger lesson we learned in this exercise and because
of our continuing effort to demonstrate to our people that we can be
faithful to their values.
Thank you very much.
A-6
The Administration Announces Actions
Responding to President Clinton's Advisory Committee on
Human Radiation Experiments
March 28, 1997
Background
In January, 1994 President Clinton established the Advisory Committee on Human
Radiation Experiments (ACHRE) to examine reports that the government had supported unethical
human radiation experiments and releases of radiation during the Cold War. He asked ACHRE to
uncover the truth, recommend ways to right past wrongs, and suggest ways to make sure the
government will not repeat past mistakes.
October, 1995 ACHRE issued its report. ACHRE found that the government had
conducted several thousand human radiation experiments from 1945 to 1975 and that the majority
advanced biomedical research. The Committee found, however, that some were conducted
unethically. For example, scientists injected plutonium into 18 patients without their knowledge,
and researchers conducted experiments on indigent patients and children. ACHRE made 18
recommendations to open the public record, protect human subjects of future research, and
compensate those wronged by the government's actions.
In October, 1995 the President received the Advisory Committee's report and made it clear
that the report would "not be left on a shelf to gather dust" He directed his Cabinet to "use and
build on these recommendations." Over the past year and a half, the Administration has acted to
implement ACHRE's recommendations to improve openness in government, strengthen ethics in
human subjects research, and compensate individuals for the government's mistakes.
Today's Announcement
The Administration released Building Public Trust, outlining its comprehensive
response to the President's Advisory Committee on Human Radiation Experiments
(ACHRE). The report summarizes actions to address ACHRE's 18 recommendations.
The Departments of Energy and Justice announced that the government has settled
compensation claims with families of all of the known individuals ACHRE
recommended for compensation. ACHRE recommended the government compensate the
families of 18 subjects of plutonium injection experiments. The government has settled
with all 16 families that came forward.
President Clinton signed a memorandum to strengthen the rights and protections of
people participating in secret, government-supported research. ACHRE
recommended that subjects of secret experiments have special protections and information.
Acting on that recommendation, the President directed agencies today to propose new rules
for secret research that would require scientists to: obtain informed consent from all
potential subjects of all secret experiments (current rules allow researchers to waive
informed consent in certain cases); disclose the identity of the sponsoring agency to
potential subjects; and tell potential subjects that an experiment is classified. The new rules
would also establish a more independent review process; require the head of the agency
conducting secret human research to approve each project; and require permanent records
of secret experiments. The President also directed federal agencies to report annually on
the number of classified human research projects and the number of subjects in each
project. A preliminary review by the Administration's human radiation Interagency
Working Group indicates that the government is not supporting any classified human
research at this time; today's directive initiates a formal, routine accounting of secret
human studies.
The Administration announced proposed amendments to the Radiation Exposure
Compensation Act of 1990 to compensate hundreds of uranium miners who would not
be compensated under current law. ACHRE found that some deserving miners do not
qualify for compensation under the Act. The amendments would establish fairer, science-
based criteria for compensation. The Administration will also propose regulatory changes
to RECA to facilitate claims processing.
Previous and On-going Actions Described in Building Public Trust Include:
Actions to Improve Openness in Government.
ACHRE transferred more than 4,000 cubic feet of documents to the National Archives. The
Administration has made 300,000 fully searchable pages of documents available on the
Internet, and will add an additional 200,000 pages shortly. The Departments of Energy and
Defense have published document search guides.
The President signed Executive Order 12958 directing Federal agencies to review and
declassify thousands of documents, including documents on radiation experiments.
Actions to Protect human subjects in the future.
President Clinton established the National Bioethics Advisory Commission (NBAC) to
examine bioethical issues, including human research issues. A subcommittee of NBAC will
address certain broad questions raised by ACHRE, including how to strengthen Institutional
Review Boards -- the local ethics panels for Federally-sponsored research.
In October, 1995 President Clinton directed agencies to develop plans to improve their
oversight of ethics rules. The agencies have completed their review and upgraded
protections, and NBAC will review agency procedures in the coming months.
Agencies have undertaken nationwide education efforts to raise the profile of ethical
considerations, and are funding research to improve our understanding of informed consent.
Actions to Right Past Wrongs.
In October, 1995 President Clinton apologized to subjects of radiation experiments and
their families on behalf of an earlier generation of American leaders and citizens; former
Energy Secretary O'Leary made apologies in certain individual cases.
The Administration will propose legislation to make veterans treated with nasopharyngeal
radiation eligible for health care services under the Veteran's Administration's Ionizing
Radiation Program.
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Glenn Bill (S. 193)
Divider Title:
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Senator
John Glenn
News Release
For Immediate Release:
Contact:
Bryan McCleary (202) 224-9799
January 22, 1997
Jack Sparks
(202) 224-7784
New Law Proposed to Prevent Researchers from
Conducting Experiments on Unsuspecting Americans
Glenn Calls on Administration to Put
Human Research Issue on Front Burner
Tough new safeguards are needed to protect the rights of
Americans who participate in medical research, Senator John Glenn
(D-Ohio) said today. Glenn made his comments as he introduced
comprehensive legislation aimed at ensuring that "informed consent"
is obtained from potential research subjects, closing gaps which
have allowed unethical human experiments, and creating first-ever
criminal penalties for violators.
"I find it astounding that after horror stories like
experiments described at Nuremberg, the thalidomide babies, and
recent revelations about Cold War radiation experiments in Ohio and
elsewhere, we still don't have a law on the books saying it is
illegal to experiment on Americans without their permission.
Glenn said a large body of federal regulations has evolved to
protect human research subjects, but he believes it ie spotty,
contains major gaps that invite abuse, often fails to give subjects
an honest picture of risks, and lacks the force of law.
"There is more protection in existing statutes for animals
than for humans, Glenn said, citing the Animal Welfare Act.
"Think about your own family, your son or daughter or parent
or grandchild. The next time they go to the doctor or hospital,
they could be the subject of some medical experiment or research
they know nothing about. There can't be anything more un-American
than that. "
Glenn is also calling on the Clinton Administration to make
this issue a higher priority. The Senator complained that a
Presidential advisory commission charged with suggesting better
protections for human research subjects is being hobbled by a lack
of funding. In a letter last week to Dr. John Gibbons, President
Clinton's science advisor and chief of the Office of Science and
Technology Policy, Glenn called the issues to be addressed by the
commission "among the most important, complex, and controversial of
our time.
Glenn says President Clinton exhibited strong leadership in
creating the National Bioethics Advisory Commission following
revelations about radiation experiments on unsuspecting subjects
during the Cold War. Now, he said, the Administration needs to
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follow through on its commitments. The Senator said that more than
15 months after its establishment, the commission is having
difficulty conducting its business because federal agencies have
not fulfilled their pledges to support it. Glenn wrote to Gibbons
that "past abuses have affected my constituents directly" and asked
him to see that the commission is fully funded.
Dr. Gibbons is meeting today with representatives from
agencies who agreed to support the commission with resources and
staff.
Glenn, the senior Democrat on the Senate Governmental Affairs
Committee, has long pushed the Government to disclose evidence
about Cold-War era excesses. He was among the first to identify
the environmental and health risks posed by U.S. nuclear production
plants. More recently, he released information about how the U.S.
government deliberately released radiation into the atmosphere
during the 1940's and 50's. Finally, he has worked on the
Governmental Affairs Committee to examine how it could happen that
Americans became unwitting guinea pigs in experiments involving
radiation and plutonium injections and exposure.
In the course of conducting hearings and spearheading
Congressional probes into radiation experiments -- one of the most
infamous sets having occurred at the University of Cincinnati --
Clenn continued to ask two questions. First: what protections are
in place to prevent such abuses from happening again? Second: what
law prohibits experimenting on people without their consent?
Today's legislation is an outgrowth of these two questions.
A number of problems with the way in which research is conducted
have been identified by Congressional investigators, the media,
Glenn and government commissions. Some examples:
*
The "common rule" -- a guideline requiring that researchers
fully inform tests subjects about experiments and submit them to a
local ethics review board -- is not applied to all U.S. medical
research. Some of private industry is exempted and not all
government research is covered. What's more, the common rule is
not law and no criminal penalties are on the books if it is
violated.
* The Cleveland Plain Dealer has identified cases where deaths
have resulted from treatments patients were not told were
experimental. In a comprehensive investigation, the paper also
reported that since 1977, more than half of the 4,154
investigations the FDA has made of drug research have shown that
researchers failed to clearly disclose the experimental nature of
their work. They also showed cases where the federal government
sponsored research where informed consent was not obtained.
*
Local ethics committees called Institutional Review Boards
(IRB's) are supposed to approve experiments while ensuring that
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researchers minimize risks, clearly inform subjects of the nature
of proposed treatment or experimentation, and let patients know
about alternative treatments. However, reports show IRB's often
face an overwhelming workload, do not check up on experiments after
they are approved, and do not receive sufficient guidance or
oversight from the federal government Glenn noted that no one
even knows how many review boards are operating nationally or what
kind of job many of them are doing.
*
Consent forms approved by IRB's for distribution to potential
subjects often gloss over the experimental nature of proposed
treatment, blurring the distinction between therapy and research.
The Advisory Committee on Human Research Experiments found such
consent forms "flawed in morally significant respects" and
concluded that over half the studies they reviewed raised "serious
or moderate concerns."
Glenn's legislation, among other things, would: apply Common
rule protections Lo all human subject research and put criminal
sanctions on the books for violators; create new protections for
classified federal experiments; provide additional protections to
vulnerable populations such as children and pregnant women; and
elevate the Office for Protection from Research Risks to newer,
more independent watchdog status.
Glenn said his bill will be referred to the Senate Labor and
Human Resources Committee. Later this week, he will introduce a
narrower bill which will deal solely with public research and will
be sent to the Governmental Affairs Committee on which Glenn serves
as ranking Member.
The Senator said he expects that both committees will hold
hearings on the issue in the near future. He said he would be
working to gather support for the legislation from his colleagues
and would also reach out to organizations representing patient
rights, veterans, senior citizens, and others.
Glenn stressed that human research is absolutely critical to
America and its development of new medicines and treatments to
fight and cure diseases. "I don't think people mind being test
subjecte if they know the pros and cons." Still, he said, "people
need to have all the facts. They need to make their decision based
on good information -- not information that is selective or slanted
or misleading."
For additional background on the issue, including a 1996
General Accounting Office report to Clenn, call 202-224-9799.
105th CONGRESS
1st Session
S. 193
To provide protections to individuals who are the human subject of research.
IN THE SENATE OF THE UNITED STATES
January 22, 1997
Mr. Glenn introduced the following bill; which was read twice and referred to
the Committee on Labor and Human Resources
A BILL
To provide protections to individuals who are the human subject of research.
Be it enacted by the Senate and House of Representatives of the United
States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the "Human Research Subject Protections Act of
1997".
SEC. 2. FINDINGS AND PURPOSES.
(a) Findings.--Congress makes the following findings:
(1) The Constitution guarantees the right of the people to be secure
in their persons, and the Declaration of Independence asserts as self-
evident that all men have certain unalienable rights among these are
life, liberty and the pursuit of happiness.
(2) The first principle of the Nuremberg code states that with
respect to human research, the voluntary consent of the human subject is
absolutely essential. The Nuremberg code further asserts that such
consent must be competent, informed and comprehending.
(3) In 1974, the Department of Health, Education and Welfare
published regulations (45 CFR 46) governing the protection of human
subjects in research. These regulations applied only to research
sponsored by the Department. In 1991 these regulations were adopted by 16
additional Federal agencies to apply to any research which these agencies
may sponsor.
(4) Between 1974 and 1983, Congress enacted 2 Public Laws that
established ethical advisory bodies. Public Law 91-348 established the
National Commission for the Protection of Human Subjects of Biomedical
Research and Public Law 95-622 established the President's Commission for
the Study of Ethical Problems in Medicine and Biomedical and Behavioral
Research. Each of these advisory bodies made recommendations to the
President and Congress to expand protections for human research subjects.
Some of these recommendations have been incorporated into the Federal
regulation (45 CFR 46).
(5) In 1995, the President's Advisory Committee on Human Radiation
Experiments found that there are significant deficiencies in some aspects
of the current system for the protection of human subjects. In
particular, the Committee found that some consent forms currently in use
are flawed in morally significant aspects.
(6) The President's Advisory Committee on Human Radiation Experiments
recommended the adoption of a Federal policy requiring the informed
consent of all human subjects of classified research and that this
requirement not be subject to exemption or waiver. The Committee further
recommended that in all cases, potential subjects should be informed of
the identity of the sponsoring Federal agency and that the project
involves classified information.
(7) Some agencies of the Federal government sponsor research
involving human subjects, but these agencies have not adopted the Common
Rule as provided for in part 46 of title 45, Code of Federal Regulations.
(8) Private individuals or institutions that do not receive any
Federal funding or that are not seeking the approval of the Food and Drug
Administration for a drug or device, and that sponsor research involving
human subjects, do not need to abide by the requirements of part 46 of
title 45, Code of Federal Regulations.
(9) Many, but not all, research institutions that receive Federal
sponsorship for research involving human subjects may voluntarily apply
the protections of the Common Rule to all research conducted at the
research institution.
(10) Notwithstanding paragraphs (1) through (9), no provision of
United States law explicitly requires that informed consent and
independent review of research involving human subject be obtained.
(11) The human research subject activities described in this section
are either in interstate (or foreign) commerce or substantially affect
such commerce or the free flow thereof, and the regulation of those
activities as provided for in this Act is necessary to prevent and
eliminate burdens upon such commerce and to effectively regulate such
commerce, in order to insure that the rights and welfare of human
research subjects are protected.
(b) Purpose.--The purposes of this Act are--
(1) to apply common rule protections to all human subject research
and provide for criminal sanctions for violations of this Act;
(2) to prohibit the provision of Federal support for classified
research that is not reviewed by an institutional review board and
require disclosure to human research subjects of certain information
regarding classified research; and
(3) to address any potential regulatory conflict of interest within
the Department of Health and Human Services and the National Institutes
of Health, and establish an Office for Protection of Research Subjects
within the Office of the Secretary of Health and Human Services.
SEC. 3. DEFINITIONS.
In this Act:
(1) Assurance.-The term "assurance" means a written agreement
between the Secretary and a research facility, or an institution
supporting the research facility, that such research facility will comply
with all Federal ethical standards regarding human subject research,
including the common rule protections. Such term includes a "single
project assurance", "multiple project assurance", and "cooperative
project assurance".
(2) Board.--The term "board" means an institutional review board
established in accordance with and for the purposes expressed in this
Act.
(3) Classified research.--The term "classified research" means
research involving human subjects that is specifically authorized under
criteria established by an Executive Order to be kept secret in the
interest of national defense of foreign policy.
(4) Common rule protections.--The term "common rule protections"
means the requirements and protections provided under part 46 of title
45, Code of Federal Regulations, as in effect on the date of enactment of
this Act.
(5) Human subject.--The term "human subject" means a living
individual about whom an investigator (whether professional or student)
conducting research obtains--
(A) data through intervention or interaction with the individual;
or
(B) individually identifiable private information.
(6) Interstate commerce.--The term "interstate commerce" has the
meaning given the term in section 201(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321(b)).
(7) Office.--The term "Office" means the Office for Protection of
Research Subjects established under section 102(a) or the Office
designated under section 102(b).
(8) Research.--The term "research" means a systematic investigation,
including research development, testing and evaluation, designed to
develop or contribute to generalizable knowledge, and those activities
for which a Federal department or agency has specific responsibility for
regulating as research activities.
(9) Research facility.--The term "research facility" means any public
or private entity, agency (including Federal, State, and other agencies)
or person that--
(A) uses human subjects in research involving interstate
commerce; or
(B) receives support under a grant, loan, contract, or other
award from a department, agency, or instrumentality of the United
States for the purpose of carrying out research using human subjects.
(10) Secretary.--The term "Secretary" means the Secretary of Health
and Human Services.
(11) State.--The term "State" means a State of the United States, the
District of Columbia, the Commonwealth of Puerto Rico, the Virgin
Islands, Guam, American Samoa, or any other territory or possession of
the United States.
TITLE I--GENERAL RESEARCH REQUIREMENTS
SEC. 101. APPLICATION OF COMMON RULE REQUIREMENTS AND PROTECTIONS.
(a) In General.--Except as provided in subsection (b), the requirements
and protections provided under part 46 of title 45, Code of Federal
Regulations, as in effect on the date of enactment of this Act, shall apply
to research conducted by research facilities using human subjects.
(b) Exception When in Conflict with Act.--The provisions of this Act
shall supersede any provision of part 46 of title 45, Code of Federal
Regulations, if such provisions are in conflict.
SEC. 102. OFFICE FOR PROTECTION OF RESEARCH SUBJECTS.
(a) Establishment.--Not later than 90 days after the date of enactment of
this Act, the Secretary shall establish within the Office of the Secretary an
office to be known as the "Office for Protection of Human Research Subjects"
or make the designation described in subsection (b).
(b) Designation.--Not later than 90 days after the date of enactment of
this Act, the Secretary may reassign the Office for Protection from Research
Risks to the Office of the Secretary and designate such Office to carry out
the duties of the Office under this Act.
(c) Funding.--The Secretary shall ensure the availability of such sums as
may be necessary to enable the Office to conduct all activities under this
Act, as well as to conduct appropriate oversight and implementation
activities.
SEC. 103. REGISTRATION OF FACILITIES.
(a) In General.--To conduct research using human subjects, a research
facility shall have in effect a valid registration with the Secretary in
accordance with this section and with such regulations as the Secretary may
promulgate.
(b) Requirements.--An application for registration under subsection (a)
shall include--
(1) a statement of the principles of the applicant research facility
with respect to the protection of the rights and welfare of humans
subjects of research conducted or supported by the research facility;
(2) a designation of the official responsible for all human subject
research conducted or supported by the applicant research facility;
(3) a designation of, and membership roster or rosters for, each
board that is responsible for reviewing human subject research conducted
or supported by the applicant research facility; and
(4) an assurance that the applicant research facility is complying
and will continue to comply with the requirements for--
(A) board membership;
(B) the functions and operations of the board;
(C) the review of research by the board;
(D) the approval of research by the board;
(E) the suspension or termination of board approval of research;
(F) the maintenance of records by the board; and
(G) obtaining and documenting informed consent from human
subjects, consent from children, and permission from parents or
guardians as provided for in the common rule protections.
(c) Period of Registration.-The registration of a research facility
shall be valid for the 3-year period beginning on the date on which the
Secretary approves the application for registration, except that such
registration may be suspended, revoked or deemed to be incomplete or
otherwise insufficient by the Secretary.
(d) Affect of Assurances.--Upon the notification of the Secretary by the
official designated under subsection (b)(2), a research facility shall be
deemed to be in compliance with the registration provisions of this section,
if that research facility has in effect a valid assurance negotiated with the
Department of Health and Human Services.
(e) Failure to Register.-- A research facility may not conduct an activity
covered by this Act if the facility is not registered with the Secretary
under this section or an assurance described in subsection (d) is not in
effect.
SEC. 104. INSPECTION AND INVESTIGATION.
(a) In General.--The Secretary may carry out such inspections or
investigations as may be necessary to enable the Secretary to determine
whether any research facility has violated or is violating any provision of
this Act.
(b) Access to Facilities and Records.--To enable the Secretary to carry
out subsection (a), the Secretary shall, after providing reasonable notice,
be provided with access to a research facility and the records required to be
kept by the facility pursuant to section 103(b)(4) and the common rule
protections.
(c) Penalties.--Title 18, United States Code, is amended by inserting
after chapter 89 the following:
"CHAPTER 90--PROTECTION OF HUMAN SUBJECTS BY RESEARCH FACILITIES
"Sec. 1841. Protection of human subjects
"(a) In General.--Whoever forcibly assaults, resists, opposes, impedes,
intimidates, or interferes with any person while such person is engaged in
the performance of his or her official duties under the Human Research
Subject Protections Act of 1997, or because such person has carried out such
duties, shall be fined not more than $10,000, or imprisoned not more than 3
years, or both.
"(b) Use of Weapon.--Whoever in the commission of an act that is a
violation of subsection (a), uses a deadly or dangerous weapon shall be fined
not more than $25,000, or imprisoned not more than 10 years, or both.
"(c) Homicide.--Whoever kills any human being while that human being is
engaged in the performance of his or her official duties under the Human
Research Subject Protections Act of 1997, or because such human being has
carried out such duties, shall be fined or imprisoned as provided for under
sections 1111 and 11 14.".
SEC. 105. ENFORCEMENT.
(a) Suspension of Registration.-If the Secretary has reason to believe
that any research facility registered under section 103 has violated or is in
violation of any provision of this Act, or of any of the rules or regulations
or standards promulgated by the Secretary under this Act, the Secretary may
suspend the registration of that research facility for a period of not to
exceed 30 days, and after notice and opportunity for a hearing, may suspend
such registration for any additional period as the Secretary may determine
appropriate. Upon a determination by the Secretary that such a violation has
occurred the Secretary may continue such suspension or revoke the
registration.
(b) Penalties.--Any employee of a research facility that knowingly
violates any provision of this Act shall, on conviction thereof, shall be
fined not more than $10,000, or imprisoned not more than 3 years, or both.
Such violation shall be referred by the Secretary to the United States
Department of Justice for prosecution.
SEC. 106. REGULATIONS.
The Secretary may promulgate such regulations as the Secretary determines
to be necessary to carry out this Act.
)
TITLE II-CLASSIFIED RESEARCH
SEC. 201. PROHIBITION.
Notwithstanding any other provision of law, no Federal funds shall be
the performance of his or her official duties under the Human Research
Subject Protections Act of 1997, or because such person has carried out such
duties, shall be fined not more than $10,000, or imprisoned not more than 3
years, or both.
"(b) Use of Weapon.--Whoever in the commission of an act that is a
violation of subsection (a), uses a deadly or dangerous weapon shall be fined
not more than $25,000, or imprisoned not more than 10 years, or both.
"(c) Homicide.--Whoever kills any human being while that human being is
engaged in the performance of his or her official duties under the Human
Research Subject Protections Act of 1997, or because such human being has
carried out such duties, shall be fined or imprisoned as provided for under
sections 1111 and 11 14.".
SEC. 105. ENFORCEMENT.
(a) Suspension of Registration.- If the Secretary has reason to believe
that any research facility registered under section 103 has violated or is in
violation of any provision of this Act, or of any of the rules or regulations
or standards promulgated by the Secretary under this Act, the Secretary may
suspend the registration of that research facility for a period of not to
exceed 30 days, and after notice and opportunity for a hearing, may suspend
such registration for any additional period as the Secretary may determine
appropriate. Upon a determination by the Secretary that such a violation has
occurred the Secretary may continue such suspension or revoke the
registration.
Clinton Presidential Records
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This marker identifies the place of a tabbed divider. Given our
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scan such dividers. The title from the original document is
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Human Subject Abuse
Divider Title:
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SERVICES
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
(
National Institutes of Health
Hand delivery or express mail:
Office for Protection from Research Risks
6100 Executive Boulevard, MSC 7507
6100 Executive Boulevard, Suite 3B01
Rockville, Maryland 20892-7507
Rockville, Maryland 20852
Phone: 301-496-7005 ext. 205
FAX: 301-402-2071
April 10, 1997
me &
James F. Childress, Ph.D.
Chairman
Mean all
Human Subjects Subcommittee
National Bioethics Advisory Commission
6100 Executive Boulevard, Suite 3C01
Rockville, MD 20892
Dear Dr. Childress:
I am writing to respond to questions raised by some members of your Subcommittee
regarding the nature and extent of human-subjects research taking place beyond the boundaries of
existing protections. Subcommittee members have made repeated reference to human subjects
involved in such activities as the "most vulnerable" of all human subjects.
In my October 4, 1996 remarks to the National Bioethics Advisory Commission, I noted
that human subjects involved in research outside the perimeter of the existing protections are
protected only by occasional state or local law or regulation, or at the discretion of the individuals
or institutions undertaking the research. In other words, I am referring to human subjects
research that is: 1) not conducted or supported by any of 17 Federal Departments or Agencies
that adhere to the Federal Policy for the Protection of Human Subjects; 2) not regulated by the
Food and Drug Administration (FDA); and 3) not voluntarily pledged to the Department of
Health and Human Services' regulations at 45 CFR Part 46.
The Office for Protection from Research Risks (OPRR) receives a number of inquiries
involving human subjects research over which it has no jurisdiction. Most are informal inquires
received over the telephone and are never pursued by OPRR. Each year, however, OPRR is
presented with several formal, written complaints that can be reviewed in sufficient depth to
confirm OPRR's lack of jurisdiction.
For example, parents of a young child who underwent experimental bone marrow
transplantation alleged that they were not adequately informed about the procedure's reasonably
foreseeable risks, including the severe brain damage which their child suffered. In a second
example, it was alleged that women who had experienced multiple miscarriages were misled about
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the substantial financial cost of participating in research to enhance pregnancy. A third example
involved a mid-level state university, where there was a considerable controversy about
appropriate confidentiality protections for subjects involved in a study of adult literacy, as well as
charges of conflict of interest among members of the university's Institutional Review Board
(IRB). In a fourth example, a woman who had been treated for breast cancer alleged that
identifiable private information from her medical record had been placed in a registry and made
available to research investigators without her consent.
In each of these examples, OPRR was unable to pursue the allegations, because it was
formally determined that the research was neither supported by the Federal government nor
voluntarily covered under an institutional Assurance of Compliance submitted to OPRR
OPRR also receives many less-formal inquires and complaints involving individuals or
institutions for which OPRR's lack of oversight authority is readily apparent.
For example, it is frequently alleged that patients have been subjected to "experimental"
treatment procedures without appropriate informed consent and without IRB review. OPRR has
received specific inquiries about the use of "experimental" techniques in gall bladder surgery;
"experimental" psychotherapy techniques; and surgery research that was not subjected to IRB
oversight, allegedly because the investigator generated a great deal of revenue for the hospital
involved.
Other examples involve breach of confidentiality in research. In one instance, it was
alleged that confidential, identifiable responses of nurses involved in research about lapses in
patient care were made available to the nurses' employers. In another instance, it was alleged that
an investigator utilized sensitive, identifiable drug abuse treatment information for research
without informed consent OF IRB review. In a third instance, it was alleged that several
physicians provided a research investigator with confidential patient identity and medical record
information without patient permission or IRB review.
The use of deception in research has also generated inquiries to OPRR. For example, one
complainant described "team management" research in which unsuspecting individuals were
subjected to a sham robbery, resulting in significant stress, fear, and anxiety. Another
complainant described "fright response" research in which participants were subjected to
unexpected and disturbing visual stimuli.
OPRR was also unable to pursue complaints alleging 1) a coercive structure of payment
for participation in weight loss research which made it extremely unlikely that subjects would
discontinue participation prior to completion of the research; 2) failure to characterize adequately
the severity of reasonably foreseeable risks associated with a research comparison of two FDA-
approved drugs; and 3) lack of parental consent and IRB review for survey research in which
children were asked sensitive questions about their own behavior and that of their parents and
friends.
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From time to time, OPRR is also made aware of media reports describing questionable
involvement of human subjects in research. A November 9, 1995 University news release
describes private-foundation funding of a dentist's study of removal and replacement of mercury
amalgam from the dental fillings of approximately 30 patients. On October 10, 1994, the New
York Times reported that a Manhattan gynecologist had successfully induced abortions in 121 of
126 patients with two FDA-approved drugs in an attempt "to show the medical community that
there is a safe, simple, effective, legal technique of terminating pregnancies that is private and
inexpensive." In another New York Times story (August 15, 1994), grade schools in North
Carolina are described as permitting industry-sponsored survey of the height of children, 80 that
short children could be identified for referral for potential treatment with genetically engineered
human growth hormone. On June 13, 1996, the San Diego Tribune reported that "four African-
American children were singled out for a race-related survey" by a local graduate student without
the permission of their parents or of the school system.
The information contained in these 19 examples drawn from OPRR files may seem
fragmentary. That is by necessity. With current authority, it is neither proper nor possible for
OPRR to pursue these incidents and many other like incidents, and to fully describe and
understand what is happening to the participants that are involved.
1 hope that the details provided herein will put to rest any uncertainty among
Subcommittee members as to the existence of a substantial problem: That is, the unwitting
participation--with attendant possibility for physical or dignitary harm-of some of our fellow
Americans in research. OPRR's experience indicates that there exists in 1997 a substantial
reservoir of such research activity.
The Nation needs the tools necessary to insure that human subjects are protected by 1)
initial and continuing IRB review, and 2) legally effective informed consent. As the
Subcommittee proceeds with its consideration of protecting the rights and welfare of human
subjects, please do not advance beyond what I would call Square One without articulating a
meaningful standard of protection for all individuals who may be research subjects.
Sincerely,
HamB.Ellis
Gary B. Ellis, Ph.D.
Director
Office for Protection from Research Risks