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Stem Cell Issue [2]
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FOIA Number: 2013-0365-F
FOIA
MARKER
This is not a textual record. This is used as an
administrative marker by the William J. Clinton
Presidential Library Staff.
Collection/Record Group:
Clinton Presidential Records
Subgroup/Office of Origin:
Public Liaison
Series/Staff Member:
Barbara Woolley
Subseries:
OA/ID Number:
20953
FolderID:
Folder Title:
Stem Cell Issue [2]
Stack:
Row:
Section:
Shelf:
Position:
S
29
1
1
2
Withdrawal/Redaction Sheet
Clinton Library
DOCUMENT NO.
SUBJECT/TITLE
DATE
RESTRICTION
AND TYPE
001. email
To Barbara Woolley; re: Appointment Request (partial) (1 page)
04/12/1999
b(7)(C), b(7)(E), b(6)
002. email
To Barbara Woolley; re: Appointment Request (partial) (1 page)
04/12/1999
b(7)(C), b(7)(E), b(6)
003. email
To Barbara Woolley; re: Appointment Request (partial) (1 page)
04/12/1999
b(7)(C), b(7)(E), b(6)
COLLECTION:
Clinton Presidential Records
Public Liaison
Barbara Woolley
OA/Box Number: 20953
FOLDER TITLE:
Stem Cell Issue [2]
2013-0365-F
jp3302
RESTRICTION CODES
Presidential Records Act - |44 U.S.C. 2204(a)]
Freedom of Information Act - [5 U.S.C. 552(b)]
P1 National Security Classified Information [(a)(1) of the PRA)
b(1) National security classified information [(b)(1) of the FOIA]
P2 Relating to the appointment to Federal office [(a)(2) of the PRA]
b(2) Release would disclose internal personnel rules and practices of
P3 Release would violate a Federal statute [(a)(3) of the PRA|
an agency [(b)(2) of the FOIA]
P4 Release would disclose trade secrets or confidential commercial or
b(3) Release would violate a Federal statute [(b)(3) of the FOIA]
financial information |(a)(4) of the PRA]
b(4) Release would disclose trade secrets or confidential or financial
P5 Release would disclose confidential advice between the President
information [(b)(4) of the FOIA]
and his advisors, or between such advisors [a)(5) of the PRA]
b(6) Release would constitute a clearly unwarranted invasion of
P6 Release would constitute a clearly unwarranted invasion of
personal privacy [(b)(6) of the FOIA]
personal privacy [(a)(6) of the PRAJ
b(7) Release would disclose information compiled for law enforcement
purposes [(b)(7) of the FOIA]
C. Closed in accordance with restrictions contained in donor's deed
b(8) Release would disclose information concerning the regulation of
of gift.
financial institutions [(b)(8) of the FOIA]
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(9) Release would disclose geological or geophysical information
2201(3).
concerning wells [(b)(9) of the FOIA]
RR. Document will be reviewed upon request.
EXECUTIVE OFFICE OF THE PRESIDENT
OFFICE OF SCIENCE AND TECHNOLOGY POLICY
WASHINGTON, D.C. 20502
July 28, 1999
MEMORANDUM FOR CHRIS JENNINGS
BARBARA WOOLLEY
FROM:
RACHEL LEVINSON PEC
SUBJECT:
Information - 7/29 PATIENTS' CURe STEM CELL BRIEFING
Patients' CURe has issued the attached media advisory, "Leading Congressional Conservatives
to Speak in Favor of Stem Cell Research," in anticipation of other upcoming events regarding
stem cell research.
In addition, Science magazine ran the attached story on NBAC's recommendations and the WH
reaction.
Attachments
cc: Arthur Bienenstock
Jeff Smith
FROM: OMNIFAX
TO:
2024566027
AUG 11, 1989 9:22AM #211 P.02
Patients
CONTACT: Joe Cerquone
(202) 293-2856
CURe
Patients' Condition for Urgent Research
MEDIA ADVISORY
Leading Congressional Conservatives to Speak In
Favor of Stem Cell Research at
Media Roundtable
What:
In anticipation of the release of the National Bloethics Advisory
Commission's final report, the final NIH guidelines regarding federal
funding stem cell research, and related activity on Capitol HIII, the
Patients' Coalition for Urgent Research (Patients' CURe) will host a
media roundtable briefing.
Who:
The Honorable Strom Thurmond (R-SC)
U.S. Senate
The Honorable Brian Bilbray (R-CA)
U.S. House of Representatives
Dan Perry, Chairman
Patients Coalition for Urgent Research
Dr. Robert Goldstein
Juvenlle Diabetes Foundation
Joseph Balley
ALS (Lou Gehrig's Disease) Patient
When:
10:00 a.m., Thursday, July 29, 1999
Where:
U.S. Capitol Building, Room HC7
Refreshments will be served
###
2021 K Street NW, Suite 305 Washington, DC 20006 Tel: 202-293-2856 Fax: 202-785-8574
THIS WEEK
PAGE 507
508
NEWS
Korean science
Watching
reform draws
the brain
protests
decipher
smells
bryo research and apply it explicitly to the
BIOMEDICINE
derivation or use of embryonic stem cells.
Representative John Porter, chair of the House
Ethicists Back Stem Cell Research,
appropriations subcommittee for Labor and
HHS, which drafts the NIH budget, has tenta-
tively set a meeting on 21 July to begin work
White House Treads Cautiously
on next year's appropriation. Although Porter
told Science that he personally supports NIH's
Research on a scientifically promising type
on these cells "is permissible under the cur-
perspective, he said he didn't want this discus-
of human cell received a vote of confidence
rent congressional ban."
sion to "overwhelm the funding process."
last week. In a decision that Stanford Uni-
With this, the Administration formally
Porter said: "I told [NIH director Harold] Var-
versity biologist Paul Berg calls "gutsy," the
backed a policy adopted by NIH and the De-
mus that we should fight the issue on the in-
National Bioethics Advisory Commission
partment of Health and
tellectual basis of what will happen with or
(NBAC) recommended on 14
Human Services (HHS)
without this kind of research. But I don't
July that the federal govern-
in January. Their legal
want to see NIH's funding wrapped up in an
ment fund not only research
experts ruled that gov-
argument that to me is tangential."
on human embryonic stem
ernment funds may be
Other members of Porter's subcommittee
cells but also the production
spent to study, but not
-including Representative Jay Dickey
of cell cultures-even if it
to derive stem cells from,
(R-AR), a sponsor of the embryo research
means sacrificing embryos.
embryos (Science, 22 Jan-
ban-reject both NBAC's view and the Ad-
In an official notice, NBAC,
uary, p. 465). Under this
ministration's compromise position. "We be-
policy, only private labs
lieve that science should serve humans, not
may develop human stem
that humans should serve science," says
"I don't want
cells from embryos, but
Dickey. He does not think the current law
NIH-funded and other
permits federal research on embryonic stem
to see NIH's
U.S.-backed researchers
cells, and says he will help take the fight to
may use them. (The re-
court, if necessary. He hasn't proposed any
funding
striction on development
change in the embryo research ban.
doesn't apply to fetal tis-
But Berg, a spokesperson for the Ameri-
wrapped up in
sue.) Even this plan is con-
can Society for Cell Biology, says NBAC
troversial, however, because some right-to-
has developed a position that he hopes will
an argument that to
life activists have declared that any destruc-
make sense to scientists and the public. He
tive use of an embryo is immoral.
calls NBAC's recommendations for moni-
me is tangential."
Despite the legal clouds, many biomedi-
toring the field "bureaucratic," but reason-
cal researchers think this field has a bright
able if they reassure the public that this re-
-John Porter
future. They say that stem cells derived
search will be guided by ethical principles.
from human embryos and fetal gonadal
-ELIOT MARSHALL
cells, which are capable of developing into
a presidential panel of 17 scholars and ethi-
a wide variety of specialized cells, may be a
RESEARCH FUNDING
cists, says it will deliver its final report (not
valuable source of transplant tissue. For the
past 9 months, NBAC has been deliberating
Michigan Plans Massive
yet finished) to the president "very soon."
The president's staff, however, didn't
over ethical guidelines that might enable
Investment Biotech
wait long to distance itself. On the same day
more rapid development of this biomedical
that NBAC reached its decision, the White
technology by opening it to public funding.
In what may be the
House released a note saying that the Ad-
NBAC concluded that the potential bene-
largest windfall for
ministration's policy will be spelled out in
fits of stem cell research outweigh the
research from a state
guidelines being drawn up by the National
disadvantages-provided the cells are
tobacco settlement so
Institutes of Health (NIH). It noted that the
drawn from embryos that would otherwise
far, Michigan Gover-
president has ruled out funding the creation
be discarded. NBAC recommended that
nor John Engler this
of human embryos for research. Congress
only "spare" embryos from fertility clinics
week signed a bill al-
has gone further, for several years adding a
be used, and only when both donors give
locating a stunning
general ban on funding embryo research to
full consent. NBAC also said that the gov-
$1 billion over the next
the NIH appropriation; the current law runs
ernment should establish a watchdog com-
20 years for a competitive
through 30 September. The White House
mittee to set ethical rules and enforce them.
biotechnology research fund for his state's
concluded: "No other legal actions are nec-
NBAC's position could have an impact on
scientists. The fund, to focus on aging and
essary at this time because it appears that
debates on biomedical funding in Congress
health, may be spent on a range of pro-
human embryonic stem cells will be avail-
this summer and fall if right-to-life advocates
grams, from research grants for diabetes to
able from the private sector," and research
seek to extend the congressional ban on em-
building new bioinformatics databases.
502
23 JULY 1999 VOL 285 SCIENCE www.sciencemag.org
THE WHITE HOUSE
WASHINGTON
July 26, 1999
MEMORANDUM FOR JOHN PODESTA
CC:
DOUG SOSNIK
STEPHANIE STREETT
LORETTA UCELLI
LARRY STEIN
CHRIS JENNINGS
MARY BETH CAHILL
DAVID BEIER
DAN MENDELSON
FROM:
NEAL LANE Jhis for n L
SUBJECT:
Stem Cell Event: Healthcare Advances for the 21st Century
Purpose
The rationale for holding this event is to enable the President to associate his Administration with
medical research that holds enormous promise for finding new treatments and cures for diseases that
afflict approximately 128 million Americans, nearly half the population of the United States. "Such
research," states Harold Varmus, head of the National Institutes of Health (NIH) "has the potential to
revolutionize the practice of medicine." The ability of the NIH to fund research using human
embryonic stem cells is being threatened by some in Congress who want to tighten the Congressional
ban on human embryo research. A White House event that makes clear the President's position in
support of human stem cell research within the context of current law will help conservative Members
who support stem cell research hold the line against efforts to broaden the ban against such research.
As has been widely reported, the White House, at this time, is endorsing a more moderate scope of
research activities than NBAC has concluded should be eligible for federal funding. Nonetheless, by
thanking NBAC for their report in a public ceremony, the White House can align itself with their core
message, which is that stem cell research should proceed cautiously under appropriate ethical
guidance. The President can use this event to take a strong stand that human stem cell research must
be done according to the highest ethical standards, and direct that NIH put appropriate guidelines and
oversight in place to ensure those standards are met. The President's efforts could be viewed as
rolling up our sleeves and directing that fresh troops, namely, our nation's world-class Federally-
funded medical research establishment, be fully dedicated to learning how to harness stem cells to
treat people with diabetes, heart disease, Parkinson's disease, cancer, and spinal cord injuries.
Seventy-four percent of Americans responded favorably to a public opinion poll on the use of Federal
funds for research using human embryonic stem cells. A White House event that endorses that view,
emphasizes the need to maintain high ethical standards, and directs NIH to move ahead with all
deliberate speed, will resonate strongly with the majority of Americans who are desperately searching
for cures and treatments for themselves and their loved ones.
Background
On the political landscape, the use of human embryos in research has been a hot button topic for the
last several years. The House Pro-Life Caucus was successful in attaching a rider to DHHS's
appropriations bill for the last four years that prohibits federal funding for any research in which
human embryos are created or destroyed. An HHS legal interpretation of this ban permits Federal
funding for research that uses human embryonic stem cells (because stem cells are not embryos), but
Representatives Dickey (R-AR) and Bliley (R-VA) oppose this research as well and have stated their
intention to broaden the ban to include stem cells. The patient advocacy groups have been active in
lobbying Congress very strongly to commit public funds and resources to allow such research. Their
efforts apparently are paying off in that neither Dickey nor Bliley have acted on their statements to
date. The timing of this event is critical. Holding it before Congress leaves will help spur the
advocacy efforts of these patients groups during the month of August in Congressional Districts
across the nation. A nationwide coalition of over 110 patient groups and professional and academic
organizations have drafted a letter in support of Federal funding of stem cell research (attached), and
it could be released in conjunction with this event.
Outline of event:
The President meets briefly with the National Bioethics Advisory Commission, and then in the East
Room, or the Rose Garden, accepts the Commission's report, briefly discusses the importance of stem
cell research, and charges NIH to move ahead with all deliberate speed to put the necessary oversight
process in place to ensure that Federally-funded stem cell research is conducted according to the
highest ethical standards. Other speakers might include Secretary Shalala, Harold Varmus, or a
parent with an ill child with a cell-failure disease.
President's suggested remarks:
The control of human stem cells may open the door to the greatest medical discoveries since
antibiotics. Every parent whose child has diabetes or any cell-failure disease is going to be riveted to
this research, because it is the answer.
The President would thank NBAC and acknowledge their efforts, discuss the importance of stem cell
research, paint a vision of the future in which certain dreaded diseases could be defeated.
Additionally, he would charge NIH to develop and implement an oversight process for stem cell
research that will ensure that our ethics are as good as our science; and that our newest technologies
must always incorporate our oldest values.
Would also acknowledge the critical role of voluntary patient groups in raising public awareness
regarding stem cells and their potential medical benefits.
Would acknowledge the past and current Federal investments in science and technology that made
this breakthrough possible, and urge Congress to provide full FY2000 funding for his Twenty-first
Century Research Fund budget request.
Would acknowledge Members of Congress and thank them for their support of biomedical research,
and for holding the line so that stem cell research can proceed.
Attachments
Americans Affected by Diseases Stem Cell Research May Help
Stem cell research could help as many as 128 million Americans. Following are facts about the
diseases that scientists say may be treated or cured with advancements in stem cell research.
Diabetes kills one American every three
minutes.¹
Condition
Americans Affected
Cardiovascular
58,000,000
Approximately 1.5 million Americans
are afflicted with Parkinson's disease
Diseases
while roughly three million more have
Autoimmune Diseases
30,000,000
at-risk, pre-symptomatic dopamine cell
loss.
2
Diabetes
16,000,000
Five Boeing 747 jumbo jets crashing
Osteoporosis
10,000,000
every day for a year equals the
563,100 Americans who die each year
from cancer.³
Cancer
8,200,000
Cardiovascular diseases remain the number
Alzheimer's
4,000,000
one cause of death among Americans.
Parkinson's
1,500,000
They accounted for 41 percent of all deaths
in 1996. 4
Burns (Severe)
300,000
In the U.S. today, 10 million individuals
Spinal Cord Injuries
250,000
already have osteoporosis and more than
18 million additional people have low bone
Birth Defects
mass, placing them at increased risk for the
150,000/ per year
disease.
5
Total
Americans
Every year in the United States two
128,400,000
million people are burned, 300,000 of
which are severe burns. 6
There are more than 80 known autoimmune diseases such as lupus, multiple sclerosis,
rheumatoid arthritis and Graves' disease. Autoimmune diseases occur when the immune
system attacks its own tissue. 7
By developing therapies for those who have spinal cord injuries and preventing injuries,
the U.S. could save as much as $400 billion on future direct and indirect lifetime spinal
cord injury costs. 8
Birth defects are the leading cause of infant death and a major cause of disability in
young people, affecting more than 150,000 babies each year. 9
About 2.7 million Americans care for people with Alzheimer's disease. 10
¹Juvenile Diabetes Foundation
⁶Onhealth.com
²Parkinson's Action Network
⁷American Autoimmune Related Diseases Assn.
National Coalition for Cancer Research
⁸American Paralysis Association
⁴American Heart Association
⁹March of Dimes
⁵National Osteoporosis Foundation
10-The Alzheimer's Association
CARAVAN
®
Stem Cell Research Polling Information
Opinion Research Corporation International was commissioned by Patients' Coalition
for Urgent Research (Patients' CURe) to conduct polling on the subject of stem cell
research. Several questions were included in our CARAVAN® Survey, a weekly
omnibus telephone survey.
Between May 6-9 the survey of 1,005 adults was conducted. Chosen through a
random-digit-sample, the adults included 503 men and 502 women 18 years of age or
older, living in private households in the continental United States.
Prior to asking a question specifically addressing federal funding for stem cell
research, a definition of the research was given. Following is the definition that was
used:
As you may already know, a stem cell is the basic cell in the body
from which all other cells arise. Medical researchers have been able to
isolate stem cells from excess human embryos developed through in
vitro fertilization and fetal tissue that has been donated to research.
Medical researchers believe that human stem cells can be developed
into replacement cells to cure diseases such as diabetes, Parkinson's,
Alzheimer's, cancer, heart disease, arthritis, burns or spinal cord
problems.
After hearing the definition, 74 percent of respondents said they favored the funding
of stem cell research by the National Institutes of Health.
Men are more likely than women to be in favor of the research funding (79% VS.
71%).
Americans who have had at least some college education are more likely to favor
the funding of research than those without any college education (78% VS. 71%).
Janet Ulrich 1-800-999-0213 phone 1-800-759-5786 fax * OPINION RESEARCH CORPORATION INTERNATIONAL
Date: TBD
The Honorable
U.S. House of Representatives
Washington, DC 20515
Dear Representative
:
This past February we wrote to you regarding our support for federal funding of research using
human pluripotent stem cells. With the Appropriations process progressing we write now to
reiterate that support and to urge you to allow this research to move forward.
Human pluripotent stem cells have enormous potential for treatment of disease because they
have the ability to form into any type of cell in the body. But only a fraction of the work that will
be necessary to transform this potential into reality has yet begun, and only a fraction of the
biomedical research community has been able to participate because the federal government has
not yet funded any of this work. The National Institutes of Health are in the process of
completing guidelines that will permit and govern the use of these cells by federally funded
investigators. Only when these guidelines are in place will it be possible to unleash the full
capability of the biomedical research workforce toward bringing the remarkable potential of
human pluripotent stem cells to fruition.
It is also clear that the American public supports federal funding of this research. A recent
nationwide survey conducted by Opinion Research Corporation International has found that 74%
of those polled favor funding of stem cell research by the NIH.
Some have argued that "adult" stem cells will be sufficient in our pursuit of treatments or cures
of various diseases. While we believe that research in the area of adult stem cells is vital to the
research effort, we are concerned that to restrict work to that area alone will prove insufficient
and would be a grave mistake. The prospect of cutting off an avenue of research as promising as
that with embryonic stem cells at this very early stage of discovery deeply troubles those of us
who conduct and promote health research. Such a prohibition could delay possible treatments
for diseases like diabetes, cancer, Alzheimer's and Parkinson's by years. Past work on animals
has shown us that it is the embryonic stem cells that hold the greatest potential in their ability to
be manipulated for treatments of disease.
We are also concerned by the argument that embryonic stem cell research can be left to the
private sector. While it is clear that a few privately funded centers are working on pluripotent
stem cell research, it is not generally the practice of private companies to conduct this kind of
basic research into fundamental developmental processes. That is why it has been and remains
the role of the federal government to make the lion's share of the investment in basic research,
which has then been used by biotechnology and pharmaceutical companies to develop products
used for treating diseases. And that is why we cannot rely on private industry to conduct the
kind of basic research necessary to move the field of stem cell research from the laboratory
bench to the clinic.
Our intent is simply to ensure that research on stem cell lines is not unduly restricted. With
appropriate ethical safeguards, such as those being developed by the National Institutes of
Health, we believe that a balance can be achieved, which respects both the moral status of the
embryo and the public's sensitivity to this issue while ensuring progress in critical medical
research. As we have said before, the government can play an important role of oversight so that
our nation's federally funded scientists can conduct this critical work. Federal support will also
increase the financial resources directed to this area of research, which will speed the pace of
scientific discovery.
With the great hope pluripotent stem cell research provides to patients ailing or dying from
devastating diseases we urge the Congress to allow this research to move forward with federal
support.
Sincerely,
Academy of Clinical Laboratory Physicians and Scientists
Alliance for Aging Research
Alliance for Lung Cancer Advocacy, Support and Education
American Academy of Allergy, Asthma and Immunology
American Academy of Child and Adolescent Psychiatry
American Academy of Ophthalmology
American Association for Dental Research
American Association of Anatomists
American Association of Dental Schools
American Association of Immunologists
American Autoimmune Related Diseases Association
American Burn Association
American College of Clinical Pharmacology
American College of Neuropsychopharmacology
American College of Obstetricians and Gynecologists
American College of Physicians - American Society of Internal Medicine
American Gastroenterological Association
American Medical Association
American Neurological Association
American Pediatric Society
American Physiological Society
American Society for Biochemistry and Molecular Biology
American Society for Bone and Mineral Research
American Society for Cell Biology
American Society for Clinical Nutrition
American Society for Investigative Pathology
American Society for Microbiology
American Society for Pharmacology and Experimental Therapeutics
American Society for Reproductive Medicine
American Society of Clinical Oncology
American Society of Hematology
American Society of Human Genetics
American Thoracic Society
American Veterinary Medical Association
Americans for Medical Progress
Association for Research in Vision and Ophthalmology
Association of Academic Health Centers
Association of American Cancer Institutes
Association of American Medical Colleges
Association of American Universities
Association of Chairs of Departments of Physiology
Association of Independent Research Institutes
Association of Medical and Graduate Departments of Biochemistry
Association of Medical School Pediatric Department Chairs
Association of Medical School Psychologists
Association of Professors of Medicine
Association of Subspecialty Professors
Association of Teachers of Preventive Medicine
Association of University Radiologists
Boston University School of Medicine
Cancer Research Foundation of America
Citizens for Public Action on High Blood Pressure and Cholesterol
Coalition for American Trauma Care
Columbia University
Cure for Lymphoma Foundation
Dartmouth Medical School
Duke University
East Carolina University School of Medicine
Easter Seals
The Endocrine Society
Eye Bank of America
Federation of American Societies for Experimental Biology
Fred Hutchinson Cancer Research Center
Genetics Society of America
Glaucoma Research Foundation
Harvard University
Interstitial Cystitis Association of America, Inc.
Johns Hopkins University
Joint Council of Allergy, Asthma, and Immunology
Juvenile Diabetes Foundation International
Krasnow Institute for Advanced Study
March of Dimes
Massachusetts Institute of Technology
Medical College of Wisconsin
Myasthenia Gravis Foundation of America, Inc.
Myositis Association of America, Inc.
National Alliance for Eye and Vision Research
National Alliance for the Mentally Ill
National Association of State Universities and Land-Grant Colleges
National Caucus of Basic Biomedical Science Chairs
National Childhood Cancer Foundation
National Coalition for Cancer Research
National Health Council
National Osteoporosis Foundation
The National Pemphigus Foundation
National Psoriasis Foundation
National Spinal Cord Injury Association
New York University School of Medicine
Oncology Nursing Society
Osteogenesis Imperfecta Foundation
Paralyzed Veterans of America
Parkinson's Action Network
The Protein Society
Research!America
Resolve, the National Infertility Association
Roswell Park Cancer Institute
Scleroderma Foundation
Sjogren's Syndrome Foundation
Society for Investigative Dermatology
Society for Pediatric Research
Society for Reproductive Endocrinology and Infertility
Society for the Advancement of Women's Health Research
University of California
University of California, San Diego, School of Medicine
University of Florida
University of Illinois at Chicago
University of Michigan Medical School
University of Pittsburgh
University of Rochester Medical Center
University of Utah Health Sciences Center
University of Washington
University of Wisconsin-Madison
UPMC Health System
Vanderbilt University Medical Center
Yale University
Stem Cell
July 15, 1999
The Honorable
U.S. House of Representatives
Washington, DC 20515
Dear Representative
:
This past February we wrote to you regarding our support for federal funding of research
using human pluripotent stem cells. With the Appropriations process progressing we
write now to reiterate that support and to urge you to allow this research to move
forward.
Human pluripotent stem cells have enormous potential for treatment of disease because
they have the ability to form into any type of cell in the body. But only a fraction of the
work that will be necessary to transform this potential into reality has yet begun, and only
a fraction of the biomedical research community has been able to participate because the
federal government has not yet funded any of this work. The National Institutes of Health
are in the process of completing guidelines that will permit and govern the use of these
cells by federally funded investigators. Only when these guidelines are in place will it be
possible to unleash the full capability of the biomedical research workforce toward
bringing the remarkable potential of human pluripotent stem cells to fruition.
It is also clear that the American public supports federal funding of this research. A
recent nationwide survey conducted by Opinion Research Corporation International has
found that 74% of those polled favor funding of stem cell research by the NIH.
Some have argued that "adult" stem cells will be sufficient in our pursuit of treatments or
cures of various discases. While we believe that research in the area of adult stem cells is
vital to the research effort, we are concerned that to restrict work to that area alone will
prove insufficient and would be a grave mistake. The prospect of cutting off an avenue of
research as promising as that with embryonic stem cells at this very early stage of
discovery deeply troubles those of us who conduct and promote health research. Such a
prohibition could delay possible treatments for diseases like diabetes, cancer,
Alzheimer's and Parkinson's by years. Past work on animals has shown us that it is the
embryonic stem cells that hold the greatest potential in their ability to be manipulated for
treatments of disease.
We are also concerned by the argument that embryonic stem cell research can be left to
the private sector. While it is clear that a few privately funded centers are working on
pluripotent stem cell research, it is not generally the practice of private companies to
conduct this kind of basic research into fundamental developmental processes. That is
why it has been and remains the role of the federal government to make the lion's share of
the investment in basic research, which has then been used by biotechnology and
pharmaceutical companies to develop products used for treating diseases. And that is
why we cannot rely on private industry to conduct the kind of basic research necessary to
move the field of stem cell research from the laboratory bench to the clinic.
Our intent is simply to ensure that research on stem cell lines is not unduly restricted.
With appropriate ethical safeguards, such as those being developed by the National
Institutes of Health, we believe that a balance can be achieved, which respects both the
moral status of the embryo and the public's sensitivity to this issue while ensuring
progress in critical medical research. As we have said before, the government can play
an important role of oversight so that our nation's federally funded scientists can conduct
this critical work. Federal support will also increase the financial resources directed to
this arca of research, which will speed the pace of scientific discovery.
With the great hope pluripotent stem cell research provides to patients ailing or dying
from devastating diseases we urge the Congress to allow this research to move forward
with federal support.
Sincerely,
American Academy of Allergy, Asthma and Immunology
American Academy of Child and Adolescent Psychiatry
American Academy of Ophthalmology
American Association of Anatomists
American Burn Association
American College of Neuropsychopharmacology
American Medical Association
American Pediatric Society
American Society for Cell Biology
American Society for Clinical Nutrition
American Society for Investigative Pathology
American Society for Microbiology
American Society for Reproductive Medicine
American Society of Hematology
American Society of Human Genctics
American Thoracic Society
American Veterinary Medical Association
Americans for Medical Progress
Association for Research in Vision and Ophthalmology
Association of Academic Health Centers
Association of American Cancer Institutes
Association of American Medical Colleges
Association of American Universities
Association of Medical School Pediatric Department Chairs
Association of Professors of Medicine
Association of Subspecialty Professors
Citizens for Public Action on High Blood Pressure and Cholesterol
Coalition for American Trauma Care
East Carolina University School of Medicine
AMERICAN COLLEGE OF OBSTETRICIANS AND GYNECOLOGISTS
The Endocrine Society
Eye Bank of America
Fred Hutchinson Cancer Research Center
Genetics Society of America
Joint Council of Allergy, Asthma, and Immunology
Juvenile Diabetes Foundation International
Krasnow Institute for Advanced Study
Massachusetts Institute of Technology
National Alliance for Eye and Vision Research
National Caucus of Basic Biomedical Science Chairs
National Childhood Cancer Foundation
National Coalition for Cancer Research
National Health Council
National Spinal Cord Injury Association
Oncology Nursing Society
Osteogenesis Imperfecta Foundation
Paralyzed Veterans of America
Research!America
Resolve, the National Infertility Association
Roswell Park Cancer Institute
Scleroderma Foundation
Society for the Advancement of Women's Health Research
Society for Pediatric Research
University of Florida
University of Washington
Histemlet.doc
THE WHITE HOUSE
WASHINGTON
July 6, 1999
MEMORANDUM FOR JOHN PODESTA
FROM:
NEAL LANE
mal
SUBJECT:
Human Stem Cell Research Update
Background: In November 1998, human embryonic stem cells were successfully isolated and
cultured in two privately funded laboratories. Human embryonic stem cells are primitive cells,
which themselves lack a specific function but have the capacity to develop into any specialized
type of cell found in the human body (such as nerve, bone, blood, or muscle cells). While this
announcement stirred great excitement in the biomedical research community, because of the
tremendous potential that stem cells have for treating human disease, the source of these cells
(human embryos and aborted fetuses) generated a great deal of controversy. The isolation of
stem cells from human embryos (but not fetuses) currently cannot be done using public funds
because of the Congressional ban on the use of Federal funds for human embryo research, which
has been attached to the HHS appropriations bill for the last four years. On November 14, 1998,
the President asked his National Bioethics Advisory Commission (NBAC) for a "thorough
review of the issues associated with such human stem cell research, balancing all ethical and
medical considerations." In January 1999, HHS General Counsel Harriet Rabb issued a decision
that the human embryo research ban did not include human embryonic stem cells, because stem
cells are not themselves embryos, and so research using these cells would be eligible for Federal
funds. The House Pro-Life Caucus has objected strenuously to this decision. However, Senators
Specter and Harkin of the Senate Appropriations Committee strongly support NIH funding of
human stem cell research (they held three hearings on this issue in late 1998), as does
Congressman Porter of the House Appropriations Committee.
Present Status: NBAC is examining the ethics of research on stem cells derived from fetuses,
embryos left over from fertility treatments, and embryos produced for research, either from
fusing donated eggs and sperm or via cloning methods. They are also considering the
ramifications of Federal funding of each of these activities. The Commissioners unanimously
agree that the use of human embryonic stem cells for research is ethically defensible and should
be eligible for Federal funding. However, there is still considerable debate over the ethics of
deriving cells from the different sources, and the use of Federal funds for such research. Even
though NBAC generally agrees that deriving cells from embryos left over from fertility
treatments is ethically acceptable, some Commissioners may recommend against using public
funds to support such a controversial activity. At this point, it appears that the Commission will
not recommend Federal funding for research using stem cells derived from embryos produced
for research purposes using either cloning or IVF technologies, which is consistent with the
President's 1994 position opposing the creation of human embryos for research purposes. NBAC
expects to finalize their report shortly after they meet next week (July 13-14) in Cambridge, MA.
NIH has drafted a set of guidelines describing the steps investigators must complete to receive
NIH funds for research involving the use of human stem cells, to be published in the Federal
Register for a 60-day public comment period, once they have received departmental clearance.
The guidelines will parallel existing regulations covering fetal tissue transplantation research.
NIH will not fund research that would include the destruction of human embryos as this would
violate the Congressional embryo research ban.
Possible Administrative Action: The release of the NBAC report and/or the publication of the
draft NIH guidelines are opportunities for an Administration statement. Two draft statements are
attached, which express support for funding research using human embryonic stem cells, but
emphasize the need for this research to be done using the highest ethical standards. Because
valuable research can proceed using stem cells that are derived using private funds, there is no
need at this time to push for a relaxation of the current Congressional ban on human embryo
research.
Attachments
Tab A Draft Statement for Neal Lane and/or Joe Lockhart
Tab B Draft Statement for POTUS
cc:
Bruce Reed
Larry Stein
Dan Mendelson
Elena Kagan
David Beier
Chris Jennings
Barbara Woolley
Barry Toiv
Joe Lockhart
Draft 7/7/99
Draft Statement for Neal Lane or Joe Lockhart when NIH Guidelines are Published/NBAC
Report is Nearing Completion
Last November, the President asked his National Bioethics Advisory Commission to
undertake a thorough review of all of the ethical and medical considerations associated with
human stem cell research. In the ensuing months, a national dialogue took place highlighting the
potential applications of stem cells for treating people with diabetes, heart disease, Parkinson's
disease, cancer, and spinal cord injury. Ethical issues were also central to this debate, including
a wide range of religious and philosophical views that are a part of the fabric of our democratic
culture. NBAC has nearly completed its deliberations and appears ready to endorse the medical
promise and ethical acceptability of certain types of human stem cell research.
The Clinton Administration recognizes that human stem cell technology's potential
medical benefits are compelling and worthy of pursuit, so long as the research is conducted
according to the highest ethical standards. NIH is putting in place guidelines and an oversight
system that will ensure that the cells are obtained in an ethically sound manner. The President's
1994 ban on the use of Federal funds for the creation of human embryos for research purposes
will remain in effect. Because it appears that human stem cells will be available from the private
sector, such research is permissible under the current Congressional ban on human embryo
research and no other legal actions are necessary at this time.
Revised Draft 7/7/99 (incorporating John Podesta's 7/6/99 edits)
Draft Statement for POTUS when NIH Guidelines are Published/NBAC Report is Released
Back in November, when I asked my National Bioethics Advisory Commission to look at
the ethical and medical issues surrounding human stem cell research, I recognized the enormous
medical potential of such research. The scientific results that have come out in just the past few
months already strengthen my basis for hope that one day, stem cells will be used to replace
cardiac muscle cells for people with heart disease, nerve cells for hundreds of thousands of
Parkinson's patients, or insulin-producing cells for children who suffer from diabetes.
But I also understand that stem cell research raises ethical concerns that need to be
addressed, and the national dialogue has highlighted a range of opinions that must be respected.
First, I want to restate the ban I issued in 1994 prohibiting the use of Federal funds for the
creation of human embryos for research purposes. Second, I will continue to insist that any
Federally-supported human stem cell research be held to the highest ethical standards. The NIH
guidelines, with input from NBAC, will be the principal mechanism to ensure this outcome,
while helping scientists turn the promise of stem cell technology into reality.
THE WHITE HOUSE
WASHINGTON
July 6, 1999
MEMORANDUM FOR JOHN PODESTA
FROM:
NEAL LANE
mal
SUBJECT:
Human Stem Cell Research Update
Background: In November 1998, human embryonic stem cells were successfully isolated and
cultured in two privately funded laboratories. Human embryonic stem cells are primitive cells,
which themselves lack a specific function but have the capacity to develop into any specialized
type of cell found in the human body (such as nerve, bone, blood, or muscle cells). While this
announcement stirred great excitement in the biomedical research community, because of the
tremendous potential that stem cells have for treating human disease, the source of these cells
(human embryos and aborted fetuses) generated a great deal of controversy. The isolation of
stem cells from human embryos (but not fetuses) currently cannot be done using public funds
because of the Congressional ban on the use of Federal funds for human embryo research, which
has been attached to the HHS appropriations bill for the last four years. On November 14, 1998,
the President asked his National Bioethics Advisory Commission (NBAC) for a "thorough
review of the issues associated with such human stem cell research, balancing all ethical and
medical considerations." In January 1999, HHS General Counsel Harriet Rabb issued a decision
that the human embryo research ban did not include human embryonic stem cells, because stem
cells are not themselves embryos, and so research using these cells would be eligible for Federal
funds. The House Pro-Life Caucus has objected strenuously to this decision. However, Senators
Specter and Harkin of the Senate Appropriations Committee strongly support NIH funding of
human stem cell research (they held three hearings on this issue in late 1998), as does
Congressman Porter of the House Appropriations Committee.
Present Status: NBAC is examining the ethics of research on stem cells derived from fetuses,
embryos left over from fertility treatments, and embryos produced for research, either from
fusing donated eggs and sperm or via cloning methods. They are also considering the
ramifications of Federal funding of each of these activities. The Commissioners unanimously
agree that the use of human embryonic stem cells for research is ethically defensible and should
be eligible for Federal funding. However, there is still considerable debate over the ethics of
deriving cells from the different sources, and the use of Federal funds for such research. Even
though NBAC generally agrees that deriving cells from embryos left over from fertility
treatments is ethically acceptable, some Commissioners may recommend against using public
funds to support such a controversial activity. At this point, it appears that the Commission will
not recommend Federal funding for research using stem cells derived from embryos produced
for research purposes using either cloning or IVF technologies, which is consistent with the
President's 1994 position opposing the creation of human embryos for research purposes. NBAC
expects to finalize their report shortly after they meet next week (July 13-14) in Cambridge, MA.
NIH has drafted a set of guidelines describing the steps investigators must complete to receive
NIH funds for research involving the use of human stem cells, to be published in the Federal
Register for a 60-day public comment period, once they have received departmental clearance.
The guidelines will parallel existing regulations covering fetal tissue transplantation research.
NIH will not fund research that would include the destruction of human embryos as this would
violate the Congressional embryo research ban.
Possible Administrative Action: The release of the NBAC report and/or the publication of the
draft NIH guidelines are opportunities for an Administration statement. Two draft statements are
attached, which express support for funding research using human embryonic stem cells, but
emphasize the need for this research to be done using the highest ethical standards. Because
valuable research can proceed using stem cells that are derived using private funds, there is no
need at this time to push for a relaxation of the current Congressional ban on human embryo
research.
Attachments
Tab A Draft Statement for Neal Lane and/or Joe Lockhart
Tab B Draft Statement for POTUS
cc:
Bruce Reed
Dan Mendelson
Elena Kagan
David Beier
Chris Jennings
Barbara Woolley
Barry Toiv
Joe Lockhart
Draft 7/6/99
Draft Statement for Neal Lane or Joe Lockhart when NIH Guidelines are Published/NBAC
Report is Nearing Completion
Last November, the President asked his National Bioethics Advisory Commission to
undertake a thorough review of all of the ethical and medical considerations associated with
human stem cell research. In the ensuing months, a national dialogue took place highlighting the
potential applications of stem cells for treating people with diabetes, heart disease, Parkinson's
disease, cancer, and spinal cord injury. Ethical issues were also central to this debate, including
a wide range of religious and philosophical views that are a part of the fabric of our democratic
culture. NBAC has nearly completed its deliberations and appears ready to endorse the medical
promise and ethical acceptability of certain types of human stem cell research.
The Clinton Administration recognizes that human stem cell technology's potential
medical benefits are compelling and worthy of pursuit, so long as the research is conducted
according to the highest ethical standards. NIH is putting in place guidelines and an oversight
system that will ensure that the cells are obtained in an ethically sound manner. The President's
1994 ban on the use of Federal funds for the creation of human embryos for research purposes
will remain in effect. Because it appears that human stem cells will be available from the private
sector, such research is permissible under the current Congressional ban on human embryo
research and no other legal actions are necessary at this time.
Draft 7/6/99
Draft Statement for POTUS when NIH Guidelines are Published/NBAC Report is Released
Back in November, when I asked my National Bioethics Advisory Commission to look at
the ethical and medical issues surrounding human stem cell research, I recognized the enormous
medical potential of such research. The scientific results that have come out in just the past few
months already strengthen my basis for hope that one day, stem cells will be used to replace
cardiac muscle cells for people with heart disease, nerve cells for hundreds of thousands of
Parkinson's patients, or insulin-producing cells for children who suffer from diabetes. (Juvenile
Diabetes Foundation, Alliance for Aging Research, Paralyzed Vets or other members of the
Patients' Coalition for Urgent Research may be invited.)
But I also understand that stem cell research raises ethical concerns that need to be
addressed, and the national dialogue has highlighted a range of opinions that must be respected.
First, I want to restate the ban I issued in 1994 prohibiting the use of Federal funds for the
creation of human embryos for research purposes. Second, I hereby direct that any Federally-
supported human stem cell research be held to the highest ethical standards. The NIH
guidelines, with input from NBAC, will be the principal mechanism to ensure this outcome,
while helping scientists turn the promise of stem cell technology into reality.
THE WHITE HOUSE
WASHINGTON
June 17, 1999
MEMORANDUM FOR JOHN PODESTA
FROM:
NEAL LANE
real
SUBJECT:
Human Stem Cell Research Update
I want to alert you to two upcoming events regarding oversight of human stem cell research and
discuss actions that we might take regarding human stem cell research and cloning for the
purpose of human reproduction.
NIH Guidelines NIH expects to send a human stem cell research oversight plan and draft
guidelines to DHHS next week. Once cleared, the guidelines will be published in the Federal
Register for a 60-day public comment period. The guidelines are expected to describe the steps
investigators must complete in order to receive NIH funds for research involving the use of
human stem cells. The guidelines will parallel existing regulations covering fetal tissue
transplantation research. NIH will not fund research that would include the destruction of
human embryos as this would violate the Congressional embryo research ban.
National Bioethics Advisory Commission Report NBAC will meet on June 28-29 to discuss
human stem cell research. The Commission expects to complete its report shortly after their
meeting on July 13-14, in Cambridge, MA. The report will respond to the President's Nov. 14,
1998 request for a "thorough review of the issues associated with such human stem cell research,
balancing all ethical and medical considerations." NBAC is examining the ethics of conducting
research on stem cells derived from fetuses, and embryos left over from fertility treatments,
embryos produced from donated eggs and sperm or via cloning methods. They are also
considering the ramifications of Federal funding of each of these activities.
Although the Commission has not yet completed its deliberations, it appears that they will
support Federal funding for research using stem cells derived from fetuses or excess embryos. A
majority of Commissioners do not draw an ethical distinction between the use and the derivation
of stem cells and are comfortable with the practice of deriving stem cells from excess embryos
for research purposes. Despite news reports to the contrary, however, NBAC has not concluded
that they will recommend that the Congressional ban be eased to allow Federally-funded
research involving the destruction of human embryos to obtain stem cells. Even without an
ethical basis, some Commissioners may recommend against using public funds to support such a
controversial activity. At this point, it appears that the Commission will not recommend Federal
funding for research using stem cells derived from embryos produced for research purposes
using cloning or IVF technologies.
Recent News Reports
It was reported in the June 14 Washington Post that two separate companies, Geron Corporation
and Advanced Cell Therapeutics, have launched programs to produce human embryos using
cloning technology. In the June 15 New York Times, Geron denied that it was producing human
embryos but was, instead, using somatic cell nuclear transfer to learn about factors produced in
the egg that turn back the developmental clock in an adult nucleus. The company may, in fact,
be producing human embryos. Advanced Cell Technology is resuming earlier somatic cell
nuclear transfer experiments using a human adult cell and a cow egg. Both companies state that
their purpose is the isolation of embryonic stem cells, and not human reproduction (i.e.,
therapeutic, not reproductive, cloning). In 1994, President Clinton banned the use of Federal
funds to create embryos for research purposes (this ban was broadened by Congress in 1995 to
include all research using human embryos), and in 1997 banned Federal funding for the use of
cloning to reproduce a human being. None of these bans apply to the private sector, although
some companies have said that they will comply with the President's voluntary moratorium.
Hill Activity
The Congressional ban on human embryo research will be debated in the HHS appropriations
process. Patient advocacy groups have formed an active coalition (Patients' CURe) that has
been very effective in making the case of the importance of stem cell research in developing
treatments for diseases such as diabetes, heart disease, Parkinson's and cancer. Rachel Levinson,
of my staff, Chris Jennings, David Beier, and Barbara Woolley, met with the coalition on April
13 to hear about their message development efforts. Chris reiterated the Administration's
position as articulated in the President's and Harold Varmus' statements on the potential medical
benefits of stem cell research.
Senators Specter and Harkin have indicated strong support for NIH funding of human stem cell
research. Senate markup of the Labor/HHS appropriations bill could come as early as July 1, but
that is unlikely.
Rep. Porter supports the Administration's position on stem cell research. House Labor/HHS
appropriations staff have said that they don't envision a tightening of the embryo research ban in
order to prohibit stem cell research. However, something along these lines can always slip in,
especially if there is an Omnibus bill.
Last month, Rep. Bliley announced that he would hold a hearing in response to press reports that
NBAC would recommend easing the ban to allow public sector research deriving stem cells. No
stem cell hearings have been scheduled.
Possible Administrative Actions
Publication of the NIH guidelines and/or release of the NBAC report are opportunities for an
Administration statement, in the event one is called for. However, I do not see a compelling
reason to make a new statement at this time. We are on record supporting human stem cell
research as a promising avenue of biomedical research. We have already stated the need for
stringent ethical oversight and publication of the NIH guidelines will reinforce this message.
In the event that NBAC recommends in mid-July that the government fund research involving
the destruction of human embryos in order to obtain stem cells, I would advise against working
toward relaxation of the current Congressional ban. Harold Varmus says valuable research can
proceed using stem cells that are derived using private funds and there is no need to go across
this line for the time being. Although fertility research could be enhanced if the ban were lifted,
the incremental approach appears to be more prudent at this juncture. Going further might lose
the support of some of the patient groups (Paralyzed Vets, e.g.) because it would bring the debate
closer to the abortion issue.
We drafted a bill to prohibit reproductive cloning (June 97) while protecting biomedical research
but it was never introduced. We could call on Congress once again to address this real area of
concern-rather than restricting biomedical research.
Additionally, we should work with FDA to clarify their regulatory authority to prevent private
sector use of cloning technology to produce a child. We might also explore other administrative
oversight options.
Given that our current positions on stem cell research and reproductive cloning are clear and
enjoy the support of patient groups and the biotechnology and pharmaceutical industries, we
need not issue new statements until we see what develops in the appropriations process.
cc: Bruce Reed
Elena Kagan
David Beier
Chris Jennings
Barbara Woolley
stere
CLONING HUMAN EMBRYOS
June 14, 1999
Context: Today's Washington Post reports that two separate companies, Geron Corporation
and Advanced Cell Therapeutics, have started programs to create cloned human embryos.
Geron Corp. is funding an unnamed American researcher to create human embryos by using
somatic cell nuclear transfer with a human adult cell and a human egg. Advanced Cell
Therapeutics is resuming earlier somatic cell nuclear transfer experiments using a human adult
cell and a cow's egg. Both companies state that their purpose in creating cloned human embryos
is for the isolation of embryonic stem cells, and not for human reproduction (i.e., therapeutic, not
reproductive, cloning). In 1994, President Clinton banned the use of Federal funds to create
embryos for research purposes (this ban was broadened by Congress in 1995 to include all
research using human embryos), and in 1997 banned Federal funding for the use of cloning to
reproduce a human being. None of these bans apply to the private sector. This article follows
on a piece in yesterday's Post, in the Outlook section, on the religious perspective of the ethics of
embryo research, which highlighted the lack of any consensus among different religious leaders
on the acceptability of using early-stage embryos to derive stem cells. That article incorrectly
stated that the National Bioethics Advisory Commission is planning to recommend that Congress
ease the embryo research ban to permit Federal funding for the derivation of stem cells from
excess IVF (in vitro fertilization) embryos. The Commission is still actively involved in
discussion of this and other issues, and has not come to final agreement.
General
Two companies are separately funding research programs to create cloned human embryos for
the purpose of deriving human embryonic stem cells that could be used therapeutically. The
Post article voiced concern that this research brings us closer to cloning human beings.
In 1997, President Clinton banned the use of Federal funds to clone a human being, and asked for
a voluntary moratorium in the private sector (see below for text). The Administration also
sent draft legislation to the Hill to outlaw reproductive cloning, however Congress did not act
on it.
The FDA has said that they have the authority to regulate the use of cloning as a reproductive
method in the private sector.
Q.
Are we closer to cloning a human being?
A.
No. Two companies have announced that they are funding American researchers to
create cloned human embryos for the purpose of isolating embryonic stem cells, which
could then be used to treat disease. Neither company has reported a success. The
possibility of using this technology for reproductive purposes remains uncertain.
Q.
Are there any laws or regulations that would restrict the creation of cloned human
embryos in the private sector?
A.
No Federal funds may be used to create human embryos, either through cloning or the
more conventional IVF technologies. Two years ago, the President issued a directive
specifically banning Federal funds for cloning a human being, and requested a voluntary
moratorium in the private sector, stating that the cloning technique of somatic cell nuclear
transfer shouldn't be used to create human beings. At the same time, the President sent
draft legislation to Congress to prohibit reproductive cloning in the private sector,
however Congress did not act on that legislation. The FDA has stated that they have the
authority to regulate the use of cloning as a reproductive method, and would prohibit its
use on the basis of safety concerns.
Text of the President's March 4, 1997, Directive on Cloning:
THE WHITE HOUSE
Office of the Press Secretary
For Immediate Release March 4, 1997
MEMORANDUM FOR THE HEADS OF EXECUTIVE DEPARTMENTS AND AGENCIES
SUBJECT: Prohibition on Federal Funding for Cloning of Human Beings
Recent accounts of advances in cloning technology, including the first successful cloning of an
adult sheep, raise important questions. They potentially represent enormous scientific
breakthroughs that could offer benefits in such areas as medicine and agriculture. But the new
technology also raises profound ethical issues, particularly with respect to its possible use to
clone humans. That is why last week I asked our National Bioethics Advisory Commission to
thoroughly review the legal and ethical issues associated with the use of this technology and
report back to me in 90 days.
Federal funds should not be used for cloning of human beings. The current restrictions on the
use of Federal funds for research involving human embryos do not fully assure this result. In
December 1994, I directed the National Institutes of Health not to fund the creation of human
embryos for research purposes. The Congress extended this prohibition in FY 1996 and FY
1997 appropriations bills, barring the Department of Health and Human Services from
supporting certain human embryo research. However, these restrictions do not explicitly cover
human embryos created for implantation and do not cover all Federal agencies. I want to make it
absolutely clear that no Federal funds will be used for human cloning. Therefore, I hereby direct
that no Federal funds shall be allocated for cloning of human beings.
WILLIAM J. CLINTON
###
05/18/99 TUE 19:10 FAX 202 944 1964
H & K
1
1002
Patients'
Draft not Public
till Thus 10:00 AL
CURe
Patients' CURe Overview
Patients' Coalition for Urgent Research
The recent advances in stem cell research could lead to new treatments and even cures for diseases that affect
millions of Americans. Doctors may one day be able to use stem cells to regenerate or replace damaged tissue
in people who live with debilitating illnesses such as Parkinson's disease, cancer, heart disease, diabetes,
Alzheimer's disease, spinal cord injuries, severe burns, osteoporosis and other diseases. Stem cell research will
also allow scientists to study cell differentiation, which holds the key to a deeper understanding of birth defects
and abnormal cell behavior, such as cancer.
Mission
The Patients' Coalition for Urgent Research (Patients' CURe) is a broad alliance of patients' groups dedicated to
informing the public, media and policymakers about the extraordinary potential of this revolutionary research.
In addition to educating, Patients' CURe is committed to ensuring stem cell research receives proper oversight
and support through federal funding.
Coalition Members
Alliance for Aging Research
The ALS Association
Nat'l Coalition of Autoimmune Patient Groups
National Health Council
American Autoimmune Related Diseases Assn.
National Marfan Foundation
American Cancer Society
National Osteoporosis Foundation
American Parkinson Disease Association
National Patient Advocate Foundation
Cancer Leadership Council
Christopher Reeve Paralysis Foundation
National Spinal Cord Injury Association
Paralyzed Veterans of America
Citizens for Public Action on Blood Pressure & Cholcsterol
Parkinson's Action Network
Cure for Lymphoma Foundation
Research!America
Glaucoma Research Foundation
Huntington's Disease Society of America
Resolve, The National Infertility Association
Society for the Advancement of Women's
Juvenile Diabetes Foundation International
Health Research
Kidney Cancer Association
Spina Bifida Assn. of America Foundation
National Coalition for Cancer Research
Tourette's Syndrome Association, Inc.
Coalition Principles
Gives Hope to Millions of Patients and their Families
No research in recent history has offered as much hope to as many as 128 million Americans suffering
from debilitating and often fatal diseases. By studying tissues that would otherwise be discarded,
researchers can potentially develop treatments and cures for our most intractable diseases, thereby saving
and improving the lives of patients and their families.
Lives will be Saved Faster
Early basic science is generally underfunded by the private sector because it does not produce
marketable products quickly enough to make the investment worthwhile. Therefore, public funding is
the only way to ensure stem cell research is thoroughly conducted. Government funding will allow
many more scientists to study stem cells, which will hasten the discovery of effective therapies.
Federal Funding Ensures Oversight and Public Accountability
Scientists who receive federal grants will be required to adhere to strict guidelines developed by the NIH
with advice from ethicists, theologians and the public. It is important for this medical research to occur
in the public domain with careful oversight and opportunities for evaluation.
2021 K Street NW, Suite 305
Washington, DC 20006
Tel: 202-293-2856
Fox: 202-785-8574
1003
05/18/99 TUE 19:10 FAX 202 944 1964
H&K
CARAVAN
®
Stem Cell Research Polling Information
Opinion Research Corporation International was commissioned by Patients' Coalition
for Urgent Research (Patients' CURe) to conduct polling on the subject of stem cell
research. Several questions were included in our CARAVAN Survey, a weekly
omnibus telephone survey.
Between May 6-9 the survey of 1,005 adults was conducted. Chosen through a
random-digit-sample, the adults included 503 men and 502 women 18 years of age or
older, living in private households in the continental United States.
Prior to asking a question specifically addressing federal funding for stem cell
research, a definition of the research was given. Following is the definition that was
used:
As you may already know, a stem cell is the basic cell in the body
from which all other cells arise. Medical researchers have been able to
isolate stem cells from excess human embryos developed through in
vitro fertilization and fetal tissue that has been donated to research.
Medical researchers believe that human stem cells can be developed
into replacement cells to cure diseases such as diabetes, Parkinson's,
Alzheimer's, cancer, heart disease, arthritis, burns or spinal cord
problems.
After hearing the definition, 74 percent of respondents said they favored the funding
of stem cell research by the National Institutes of Health.
Men are more likely than women to be in favor of the research funding (79% vs.
71%).
Americans who have had at least some college education are more likely to favor
the funding of research than those without any college education (78% vs. 71%).
Janet Ultich . 1-800-999-0213 phone 1-800-759-5786 fax OPINION RESEARCH CORPORATION INTERNATIONAL
Joanne S. Tornow
76%
05/18/99 01:27:45 PM
Record Type:
Record
To:
Christopher C. Jennings/OPD/EOP@EOP, Barbara D. Woolley/WHO/EOP@EOP
CC:
Subject: Patients' CURe meeting today
FYI
Forwarded by Joanne S. Tornow/OSTP/EOP on 05/18/99 01:27 PM
Penny Catterall <[email protected]>
05/18/99 12:46:42 PM
Record Type:
Record
To:
Joanne S. Tornow/OSTP/EOP, Rachel E. Levinson/OSTP/EOP
CC:
"Perry, Dan" <[email protected]>
Subject: Patients' CURe meeting today
FYI - Dan Perry asked me to forward this notice which I sent out earlier
today.
This is a notice that the Patients' CURe will be having its final press
conference planning meeting this afternoon at 2:00 pm at the offices of Hill
and Knowlton at 600 New Hampshire Avenue, Watergate complex, 6th floor. If
you wish to participate by conference call, please call Krista Donahue at
H&K at (202) 944-5108 this morning and give her your phone number.
Also, if your group is a patient member of the coalition and you wish to
have a statement on the importance of stem cell research to your
constituency included in the press packet that is mailed out to reporters
tomorrow, please either bring it to the meeting or have it messengered to
Hill and Knowlton before COB today. So far, we only have one statement from
one group to include. If you cannot get a statement ready by today, please
bring at least 50 copies on your letterhead to the press conference on
Thursday morning and it will be put out on the press table at that time.
If endorsing groups (i.e. non-patient based) wish to put out a statement,
your main thrust should be the endorsement of Patients' CURe and the
coalition's focus and efforts, with lesser emphasis on stem cell research
itself. Please contact Krista at H&K at [email protected] if you
have any questions about the content of a statement.
Finally, for the information of those new groups signing on either as
members or endorsers, the press conference to announce the coalition and
strong national support for stem cell research will take place in the
Capitol in room HC6 at 10:00 am on Thursday, May 20. We strongly urge ALL
coalition groups to be represented at the press conference by at least one
senior member of their organization. While you will not have to speak
formally, your group may be asked questions by the media after the
announcement, and we would like to have a very strong showing from all
involved.
Thanks,
Penny
Penelope B. Catterall
Director, Corporate and Foundation Relations
Alliance for Aging Research
(202) 293-2856
Penelope B. Catterall
Director, Corporate and Foundation Relations
Alliance for Aging Research
(202) 293-2856
Penelope B. Catterall
Director, Corporate and Foundation Relations
Alliance for Aging Research
(202) 293-2856
Penelope B. Catterall
Director, Corporate and Foundation Relations
Alliance for Aging Research
(202) 293-2856
Penelope B. Catterall
Director, Corporate and Foundation Relations
Alliance for Aging Research
(202) 293-2856
Joanne S. Tornow
05/18/99 12:31:08 PM
Record Type:
Record
To:
Barbara D. Woolley/WHO/EOP@EOP
CC:
Subject: FWD: Patients' CURe
FYI, status of March of Dimes.
Forwarded by Joanne S. Tornow/OSTP/EOP on 05/18/99 12:30 PM
Dan Perry <[email protected]>
05/18/99 11:25:23 AM
Record Type:
Record
To:
Joanne S. Tornow/OSTP/EOP
CC:
[email protected]
Subject: FWD: Patients' CURe
Note: Some recipients have been dropped due to syntax errors.
Please refer to the "$AdditionalHeaders" item for the complete headers.
Joanne,
Here is the message I received from Jess Melanson who has been representing
the March of Dimes at our weekly strategy meetings. This states where we
stand with MOD and Marina Weiss' current position. Help from your folks
could be decisive here.
--Dan
Original Message from "Melanson, Jess" <[email protected]> at
5/17/99 4:12 pm
>Original Recipient(s):
>To: TLESHAN <[email protected]>
>
dperry <[email protected]>
>
>| have some unfortunate news regarding our efforts to include the March of
>Dimes as a member of Patients' CURe. Marina just informed me that her
>meeting today with our President, Research Director, and Medical Director
>was canceled, and we can take no action until they meet.
>
>| pushed the idea of the March of Dimes simply signing on as a member before
>the press conference and defining our role at a later date, but she
>maintains that the foundation will take no action until we have a clear
>strategy that has been endorsed by key members of the organization.
>
>| will attend tomorrow's meeting, but any further questions on this matter
>will have to be directed toward Marina as this is now out of my hands. I'll
>keep you posted of any further developments.
>
>
>Jess Melanson
>Associate Director of State Affairs
>March of Dimes
>1901 L St., NW, Ste. 200
>Washington, DC 20036
>(202) 659-1800
Dan Perry
Executive Director
Alliance for Aging Research
(202) 293-2856
(202) 785-8574 (fax)
[email protected]
summit yougher
dperry @ AGINGRESEARCH.ORG
4/16/99 04:44:00 PM
Record Type:
Record
To:
Barbara D. Woolley
Purpose: st. j to
MGWT
CC:
Subject: stem cell coalition
Rachel,
I found your email address, at last, so I can pass on these thoughts on
major patient groups where we need help in getting commitments to the stem
(Deart I sheld
cell coalition. We currently have 15 groups signed on, the latest being the
Sprina Bifuda Association Foundation. I believe you have the others on a
onwed
list.
The top targets still outstanding are: 1) American Heart Association; 2)
American Cancer Society; 3) Alzheimer Association; Arthritis Foundation; and
the Multiple Sclerosis Society. These are all high profile, important
"alye
patient groups for diseases that likely will be approached far more
effectively because of what we will learn from stem cell research.
Christopher Reeve Paralysis Foundation. I don't have to tell you how
nothing
conce forally
Park
It was also just announced this week that two groups have merged to form the
valuable that name is. Two other groups I have not mentioned because I am
sure they will agree to the coalition without further pressure are the March
of Dimes Birth Defects Foundation and the Paralyzed Veterans of America.
I
would
be
happy
to
talk
with
anyone
about
the
status
of
approaches
to
these
1000
groups. Calls from the right people in the Clinton Administration could be
decisive in bringing these names to our coalition.
privo
Incidentally, I just learned that our message testing strategy will be in
the field next Thursday with two focus groups in Lansing, MI, followed the
next Wednesday by two groups in Nashville, TN.
>won't charge
differs.
Let me know how I can support your good efforts.
--Dan
them
shalala- / bten Cell -wed
leadership
fetal Pad issue-diag
march Dine
Marina Wass
659 1800
rd
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COLLECTION:
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Record Type:
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cc:
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ADDRESSEES: BARBARA_D._WOOLLEY
SUBJECT: CONFIRMATION: APPT. REQUEST FOR WOOLLEY, BARBARA
[voi
FROM:
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04/12/99 06:28:00 PM
Record Type:
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FROM:
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This message serves as confirmation of an appointment for the
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anyous
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Rachel E. Levinson
04/13/99 12:47:49 PM
Record Type:
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To:
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CC:
Subject: stem cell meeting at 3 today - updated agenda and list of attendees
Human Stem Cell Research
April 13, 1999, 3 p.m.
OEOB, Room 100
Agenda
1. Introductions
Attendees
2. Opening Remarks
Chris
Jennings
Jennifer
Luray
Welcome. Describe point in Weekly Standard that GOP may be planning to raise human stem cell
research and tightening of the Congressional ban on embryo research as part of anti-choice movement.
We convened this meeting to convey this information, to touch base once again with groups who are
following this issue and have been helpful to us in the past, and to hear what they have been working on
to ensure that important biomedical research is not constrained unnecessarily.
The President has already stated very clearly the "promising significant medical benefits" of human stem
cell research (Nov. 14 letter to NBAC). We have been working very closely with Harold Varmus and
others at HHS to ensure that such research would be carried out under appropriate oversight and in
accordance with the highest ethical standards.
4. Brief Reports on Status of Relevant Activities
National Bioethics Advisory Commission
Rachel Levinson
The Commission is preparing a report to the President in response to his Nov. 14 request and has
reached a degree of consensus in support of the use of human stem cells derived from aborted fetuses
and from embryos left over from infertility treatment. There is concern on the part of at least one
commissioner regarding HHS' determination that the embryo research ban does not apply to use of stem
cells. Alex Capron agrees with this conclusion but feels that use of the cells cannot be decoupled from
derivation of the cells from embryos. The Commission hopes to have a report completed around June or
July.
NIH Ad Hoc Advisory Panel
Lana
Skirboll
On April 8, Harold Varmus convened an ad hoc panel in a public forum to help NIH develop an oversight
process and guidelines for the ethical use of human stem cells in federally-funded research. This meeting
was a first step in a deliberative process. Once the panel finishes their draft guidelines, NIH plans to
publish them for a 60-day public comment period. A final version must be approved by Dr. Varmus'
advisory committee before he will consider moving ahead to fund human stem cell research. During a
public comment session, a representative of the House Pro-Life Caucus reiterated earlier Congressional
statements that Federal funding of human stem cell research violates the Congressional ban on human
embryo research.
5. Report on Congressional Activity and Meetings
Attendees
Several groups have been active in meetings with Hill staff. Patient advocacy groups and scientific and
professional societies met in February to discuss legislative strategy for forestalling a tightening of the ban
on federally-funded human embryo research. While some advocate using stem cells as tool for attacking
the ban altogether (AAMC and American Society for Reproductive Medicine), others are uncomfortable
with this approach and fear that it might provoke a backlash in the form of a more restrictive ban via HHS
approps.
6. List of Attendees
Robyn Lipner, Bass and Howes Inc., Parkinson's Disease
Charles Ludlam, BIO
Jess Melanson, March of Dimes
Mara Guarducci, Pharmaceutical Research and Manufacturers of America
Victoria Blattner, Merck
Ida Chow, Society for Developmental Biology
Nina Weinberg, National Health Council
Pamela Dougherty, American Cancer Society
Sean Tipton, American Society for Reproductive Medicine
Daniel Perry, Alliance for Aging Research
Lawrence Soler, JDF International
Sara Milo, NCCR
Timothy Leshan, American Society for Cell Biology
Dave Moore, Association of American Medical Colleges
Karen Hendricks, American Academy of Pediatrics
Harley Thomas, Paralyzed Vets Association
Pat White, American Association of Immunologists
Sam Turner, Geron
THE WHITE HOUSE
WASHINGTON
November 14, 1998
Dr. Harold Shapiro
Chair
National Bioethics Advisory Commission
Suite 3C01
6100 Executive Boulevard
Bethesda, Maryland 20892-7508
Dear Dr. Shapiro:
This week's report of the creation of an embryonic stem cell that
is part human and part COW raises the most serious of ethical,
medical, and legal concerns. I am deeply troubled by this news of
experiments involving the mingling of human and non-human species.
I am therefore requesting that the National Bioethics Advisory
Commission consider the implications of such research at your
meeting next week, and to report back to me as soon as possible.
I recognize, however, that other kinds of stem cell research
raise different ethical issues, while promising significant medical
benefits. Four years ago, I issued a ban on the use of federal
funds to create human embryos solely for research purposes; the
ban was later broadened by Congress to prohibit any embryo research
in the public sector. At that time, the benefits of human stem
cell research were hypothetical, while the ethical concerns were
immediate. Although the ethical issues have not diminished, it
now appears that this research may have real potential for treating
such devastating illnesses as cancer, heart disease, diabetes, and
Parkinson's disease. With this in mind, I am also requesting that
the Commission undertake a thorough review of the issues associated
with such human stem cell research, balancing all ethical and
medical considerations.
I look forward to receiving your reports on these important issues.
Sincerely,
Bin Cunton
National Institutes of Health
Department of Health and Human Services
March 30, 1999
FACT SHEET ON STEM CELL RESEARCH
The Department of Health and Human Services (DHHS) has concluded that current law permits
federal funds to be used for research utilizing human pluripotent stem cells. The National Institutes
of Health (NIH) plans to move forward in a careful and deliberate fashion to develop rigorous
guidelines that address the special ethical, legal, and social issues relevant to this research. The NIH
will not fund research using human pluripotent stem cells until guidelines are developed and widely
disseminated to the research community and an oversight process is in place.
The Promise of Stem Cell Research
Scientists have recently isolated and successfully cultured human pluripotent stem cells¹. These
human pluripotent stem cells have an unlimited capacity to divide, and the ability to develop into
most of the specialized cells or tissues in the body.
This advance represents a major step forward in human biology and has generated much enthusiasm
and interest among scientists and the public, particularly patients and their families. Because these
cells can give rise to many different types of cells, such as muscle cells, nerve cells, heart cells, blood
cells, and others, they are enormously important to science and hold great promise for advances in
health care. For example, further research using pluripotent stem cells may help us:
Generate cells and tissue that could be used for transplantation. Pluripotent stem cells may be
stimulated to develop into many different specialized cells of the body, which may someday
be used as replacement cells and tissue to treat many diseases and conditions including
Parkinson's disease, spinal cord injury, stroke, burns, heart disease, diabetes, and arthritis.
Improve our understanding of the complex events that occur during normal human
development and also help us understand what goes wrong to cause diseases and conditions
such as birth defects and cancer.
Change the way we develop drugs and test them for safety and potential efficacy. New
medications could be tested using human pluripotent stem cells, such as liver cells or skin
cells; only the drugs which are both safe and appear to have a beneficial effect would graduate
to human testing.
Legal Issues
These human pluripotent stem cells were isolated using two different methods. One group of
¹Michael Shamblott, et al, Derivation of pluripotent stem cells from cultured human
primordial germ cells. PNAS, 95: 13726-13731, Nov. 1998.
James Thomson, et al, Embryonic stem cell lines derived from human blastocysts.
Science, 282: 1145-1147, Nov. 6, 1998.
scientists derived the pluripotent stem cells from early-stage embryos donated by people who were
undergoing fertility treatment in an in vitro fertilization (IVF) clinic. Another group of scientists
isolated the pluripotent stem cells from non-living fetuses obtained from pregnancies that had been
terminated. In both cases, all of the individuals gave full informed consent for the embryos or fetal
tissue to be used in research. Neither research project utilized federal funds. Because of the
regenerative capacity of pluripotent stem cells, a single culture of human pluripotent stem cells could
supply numerous other researchers.
Federal law currently prohibits the DHHS from funding human embryo research. In light of this
legislative ban, the Director of the NIH sought a legal opinion from the DHHS Office of the General
Counsel on whether DHHS funds may be used for research utilizing human pluripotent stem cells.
After a thorough analysis of the law, DHHS concluded that the congressional prohibition on the use
of DHHS funds for certain types of human embryo research does not apply to research utilizing
human pluripotent stem cells because such cells are not embryos. The legal opinion also clarified that
human pluripotent stem cells derived from non-living fetuses would fall within the legal definition of
human fetal tissue and are, therefore, subject to certain Federal restrictions on the use of such tissue.
Thus, research using pluripotent stem cells derived from human embryos can be funded by DHHS.
Research that generates and uses pluripotent stem cells from non-living fetuses can also be supported
by DHHS, subject to existing law and regulation.
NIH Support
In view of the scientific and medical benefits that may result from research using pluripotent
stem cells, the NIH plans to fund research using these cells. It is essential that the Federal
government play a role in funding and overseeing the conduct of this research, so that all
scientists--both privately and federally funded--have the opportunity to pursue this important line
of research. Federal funding will provide oversight and direction that would be lacking if this
research were the sole province of industry and academe.
The NIH understands and respects the compelling ethical, legal, and social issues relevant to
pluripotent stem cell research and is sensitive to the need for stringent oversight of this research
that goes beyond the traditional NIH scientific peer review process. In light of these issues, the
NIH plans to move forward in a careful and deliberate way, prior to funding any research
utilizing pluripotent stem cells.
In an effort to ensure that any research utilizing human pluripotent stem cells is appropriately and
carefully conducted, the NIH will convene a Working Group of the Advisory Committee to the
Director (ACD), NIH to advise the ACD on guidelines and oversight for research involving
human pluripotent stem cells, at the Bethesda Marriott, 5151 Pooks Hill Road, Bethesda,
Maryland 20814, on April 8, 1999. The meeting will begin at approximately 9:00 a.m. and end
at approximately 5:30 p.m. The goal of the Working Group is to provide advice to the ACD
about the scientific, ethical, legal, and social issues relevant to guidelines for the conduct of
research utilizing human pluripotent stem cells. The working group will meet in public session
and will be composed of scientists, patients and/or their families, ethicists, clinicians and
lawyers. They will be asked to consider advice from the National Bioethics Advisory
Commission (NBAC), the public, and the Congress. Once developed, guidelines for research
utilizing human pluripotent stem cells will be published in the Federal Register for public
comment. Until both the guidelines and the oversight process are in place, interested
investigators have been notified, via the NIH web site, NIH program staff, and the Deputy
Director for Intramural Research that they cannot use DHHS funds to conduct research using
human pluripotent stem cells.
Congress of the United States
Mashington, DC 20515
February 11, 1999
The Honorable Donna E. Shalala
Secretary of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201
Dear Madam Secretary:
Last month the General Counsel at HHS, Harriet Rabb, issued a memorandum to Dr.
Harold Varmus, Director of the National Institutes of Health (NIH), supporting the claim that
taxpayer funds may be used for research on stem cells taken from living human embryos.
Shortly thereafter, and using the Rabb memo as a basis, Dr. Varmus announced that NIH will
reverse current federal policy and begin funding research which relies on the mutilation and
destruction of human embryos.
We wish to express to you, in the strongest possible terms, our objection to Ms. Rabb's
memo and to Dr. Varmus's decision. Any NIH action to initiate funding of such research would
violate both the letter and spirit of the federal law banning federal support for research in which
human embryos are harmed or destroyed.¹ Rather than providing guidance on how best to
implement the law that Congress passed and the President signed, the memorandum appears to
be a carefully worded effort to justify transgressing that law.
In her memorandum Ms. Rabb makes significant errors on the way to her conclusion that
it would be permissible for NIH to fund research using stem cells harvested from human
embryos. We call upon you to correct the General Counsel's interpretation and to reverse Dr.
Varmus's decision.
Since January 1996, Congress has included in the annual Labor, Health and
Human Services, Education Appropriations Act a section prohibiting funding for this type of
research. Section 511 of the most recently enacted research funding bill, Public Law 105-277,
provides (in part) that--
(a) None of the funds made available in this Act may be used for-
(1) the creation of a human embryo or embryos for research purposes; or
(2) research in which a human embryo or embryos are destroyed,
discarded, or knowingly subjected to risk of injury or death greater than that
allowed for research on fetuses in utero under CFR 46.208(a)(2) and section
498(b) of the Public Health Service Act (42 U.S.C. 289g(b)).
PRINTED ON RECYCLED PAPER
SENT BY
The Honorable Donna E. Shalala
February 11, 1999
At the start of her analysis, the General Counsel unilaterally narrows the meaning of
"research in which a human embryo or embryos are destroyed" and states that it prohibits only
direct federal funding of the specific act of destroying the embryo. In this way she limits the
scope of the law passed by Congress. While the act of destroying or injuring an embryo would
certainly be ineligible for Federal funding, the law has a broader application. It also bars the use
of tax dollars to fund research which follows or depends upon the destruction of or injury to a
human embryo.
Congress could have structured paragraph (2) of subsection (a) of the law like paragraph
(1) and simply prohibited the use of funds for the destruction or discarding of human embryos.
We did not do that, and by established rules of statutory construction, IIHS may not construe the
law's provision on "research in which" embryos are destroyed as narrowly as its provision on the
creation of embryos.² Instead. we prohibited the funding of research projects in which the lothal
dissection or harmful manipulation of living human embryos is a necessary prerequisite,
including projects where the material used in the experiments is obtained by destruction of an
embryo that would not otherwise be done (or not otherwise done in the same way). In
congressional testimony, Dr. Varmus has confirmed that it is impossible to obtain stem cells
from embryos for these experiments without destroying the embryos.
The Rabb memo also ignores the policy reflected in current law on fetal tissue
transplantation research using tissue from intentionally aborted children. While that law is itself
open to criticism, it at least bans the use of fetal tissue in federally funded research If abortion
was Induced for the purpose of providing the tissue. Under current law, federal funds may not be
used for fetal tissue transplantation experiments following an abortion if the timing and method
of the abortion were altered solely for the purpose of providing usable tissue for research. Yet, in
the embryonic stem cell research which NIH proposes to fund, the timing, method and
procedures for destroying the cmbryonic child would be determined solely by the federally
funded researcher's need for usable stem cells.
Finally, both-Ms. Rabb's memorandum and Dr. Varmus's testimony before a Scnate
subcommittee present a new definition of "human embryo" that would undermine both the
congressional rider on embryo research, and the President's own 1994 directive against using
federal funds to create human embryos for research purposes. They now say that an entity is an
"embryo"only if one can show that it is capable, if implanted in the womb, of becoming a born
"human being." This narrow definition has no support whatsoever in federal law.
When a law has two parallel clauses, one of which is deliberately written in broader
terms than the other, it may not be interpreted to have the same meaning as the narrower clause.
See Russello V. United States, 464 U.S. 16, 23 (1983), and cases cited therein.
The Honorable Donna E. Shalala
February 11, 1999
Nevertheless. researchers are already offering to use damaged human embryos in their
destructive research. or even to engineer lethal defects in advance into the embryos they create
for such research, in order to take advantage of this Administration cover and ignore the
congressional and presidential directives altogether.
For more than 20 years, Federal laws and regulations have protected the human embryo
and fetys from harmful experimentation at the hands of the Federal government - regardless of
whether the embryo is "perfect" or damaged, wanted or unwanted, intended for abortion or
intended for live birth. This area of law has provided a bulwark against government's misuse
and exploitation of human beings in the name of medical progress. It would be a travesty for this
Administration to attempt to unravel this accepted ethical standard.
We urge you to review this issue carefully, and to put a stop to a proceeding which so
clearly does violence to the meaning and intent of Federal law.
Sincerely,
Spen
JAY DICKEY. M.C.
SPENCER BACHUS. M.C.
Hanny Hyde HENRY J. HYDE, M.C.
Ron Pasbard
RON PACKARD, M.C.
JOE BARTON, M.C.
fe Barban
Dan Burton
DAN BURTON, M.C.
Billy Jangin W.J. (BILLY) TAUZIN, M.C.
DUNCAN HUNTER, M.C.
2
SENT BY
The Honorable Donna E. Shalala
February 11, 1999
JOSEPH R. PITTS, M.C. GARY G Says MILLER, M.C. nD
Don Yenns Tood Tight
RONLEWIS, M.C.
TODD TIAHRT M.C.
Robert. ROBERT B. ADERHOLT, Adertees M.C. CHIP PIC PING, M.C
PETER Pitcking T. KING, M.C.
JO N SHIMKUS, M yr
ЛМ Jine RYUN, M.C.
Laz STEPHEN E. BUYER, M.C.
Ron Paul
BOB SCHAFFER, M.C.
RON PAUL, M.C.
Pet Horbeta
Pas RETE SESSIONS, M.C. Sussis
PETER HOEKSTRA, M.C.
The Honorable Donna E. Shalala
February 11, 1999
JOHN
John COOLITTLE, T. M.C. Dolittle
JOHN
Jon HOSTETTLER, Hostetler M.C.
David Mclatool
DAVID M. McINTOSH, M.C.
RICK
HILL Rick M.C. Hill
HELEN CHENOWETH, M.C.
JAMES
J A BARCIA, Barcia M.C.
Eluis SmiTh
CHARLES Clinit. T. CANADY, Conada M.C.
CHRISTOPHER H. SMITH, M.C.
Six Rahall
Steve Largent
NICKT. RAHALL П, M.C.
STEVE LARGENT. M.C.
Did Anny
Ravie Show
RICHARD K. ARMEY, M.C.
RONNIE SHOWS, M.C.
Majority Leader
Rom alohm
/ BALANT
TOM A. COBURN, M.C.
LINCOLN DIAZ-BALART, M.C.
3
The Honorable Donna E. Shalala
February 11, 1999
CHRIS CROK JOHNMM.C.
K KEVIN BRADY. M.S. Brany
Aar
ASA HUTCHINSON, M.C
PHIL ENGLISH, M.C.
Part Road
Tom Tanus
PAUL RYAN,M.C.
TOM TANCREDO, M.C.
ROBERT
Bob W. NEY, ny M.C. JIM TALENT. M.C.
Jack Metar
Donald A. Manzyllo
JACK METCALF, M.C.
DONALD A. MANZULLO, M.C.
DEMINT. Jim M.C. DeMint
PaweWeller
JIM
DAVE Tom Lex WELDON, M.G.
RAY LaHOOD, M.C.
TOM LATHAM, M.C.
The Honorable Donna E. Shalala
February 11, 1999
Ray Blent
Ave Myricl
ROY BLUNT. M.C.
SUE MYRICK, M.C.
CHARLES Charles H. TAYLOR, H. Dolor M.C.
Phil Crave
PHILIP M. CRANE. M.C.
Ed Whitfit
Sym Charat
ED WHITFIELD, M.C.
STEVE CHABOT, M.C.
mile Fabs
make Souder
MICHAEL P. FORBES. M.C.
MARK E. SOUDER, M.C.
JOHN John E. PETERSON. E M.C. Peterson TOM Majority Iom DoLAY, Whip M.C. Delay
MA COB BARR, M.C
RICHARD H. BAKER, M.C.
Mahr Mr Intyn
Vinge Broon
MIKE McINTYRE. M.C.
VIRGIL H. GOODE, Jr., M.C.
"
4
The Honorable Donna E. Shalala
February 11, 1999
Daird D. Pholps Ling Dan
DAVID D. PHELPS, M.C.
LINDSAY O. GRAHAM. M.C.
Einust lotal
IKE SKELTON, M.C.
ERNEST J. ISTOOK, Jr., M.C.
Saloman P. Orting
SOLOMON P. ORTIZ. M.C.
J.C. WATTS, Jr., M.C.
Republican Conference Chairman
THE SECRETARY OF HEALTH AND HUMAN SERVICES
WASHINGTON. D.C. 20201
USA
FEB 23 1999
The Honorable Jay Dickey
U.S. House of Representatives
2453 Rayburn House Office Building
Washington, DC 20515
Dear Mr. Dickey:
Thank you for your letter dated February 11, 1999, concerning the recent announcement by the
Director of the National Institutes of Health (NIH) regarding federal funding for research
utilizing human pluripotent stem cells. As you know, this research has the potential to lead to
great progress in our treatment of debilitating and deadly diseases, our understanding of human
development and our ability to develop and test new drugs. Stem cell research is richly
promising, yet raises important ethical issues. Therefore, Dr. Varmus and his colleagues at the
National Institutes of Health (NIH) will proceed with great caution to ensure that the highest
standards are set before moving forward in this area.
In keeping with the important ethical concerns that must be considered, the NIH plans to proceed
in a careful and deliberate fashion to develop rigorous guidelines. A working group of the
Advisory Committee to the Director of NIH will develop guidelines for the conduct of research
using pluripotent stem cells and will recommend an oversight mechanism for protocol review.
The National Bioethics Advisory Commission is studying these issues and will provide us with
advice that - together with counsel from outside experts, Congress and other interested parties --
will help ensure appropriate oversight.
First and foremost, these guidelines will ensure that any research funded in this area is consistent
with the prohibition on federal funding for human embryo research contained in section 511 of
the HHS appropriations law. Since this prohibition was first enacted in 1996, the Department of
Health and Human Services (HHS) has conscientiously adhered to its strictures. For example,
we have included the restriction on the use of funds in the NIH Grants Policy Statement and have
issued notices reminding NIH intramural staff and the extramural research community that they
must observe the prohibition. When necessary, we have not and will not hesitate to take
appropriate enforcement action. I am firmly committed to our continued adherence to the law.
Your letter makes specific inquiries regarding a legal memorandum on this subject from the HHS
General Counsel. You suggest that the legal analysis is problematic because it relies on a new
definition of human embryo that would undermine the Congressional prohibition. In fact, the
memorandum relies on the definition provided in the statute itself. The statute defines human
embryo as "any organism ... that is derived from one or more human gametes or diploid cells."
168505
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The legal memorandum, relying on the scientific definition of the word "organism", concludes
that the stem cells at issue are not organisms and therefore cannot be considered human embryos
under section 511 of the HHS appropriations law.
The prohibition on federal funding for human embryo research bars the expenditure of federal
funds for the creation of a human embryo for research purposes or for research in which a human
embryo is destroyed, discarded or knowingly subject to greater than minimal risk. You suggest
that this provision should be read to also bar federal funding for research which follows or
depends upon the destruction of or injury to a human embryo. The plain language of the statute
supports the opinion issued by the General Counsel. The law applies by its terms to research in
which "a human embryo or embryos are destroyed, discarded" or subjected to more than minimal
risk, and not to research preceding or following such research projects. Moreover, I have been
advised that there is nothing in the legislative history to suggest that the provision was intended
to prohibit funding for research in which embryos - organisms - are not involved.
I have reviewed our Department's position and am reassured that proceeding cautiously with
research on existing pluripotent stem cell lines is both legal and appropriate. Further, it will
allow the NIH to foster world-class research on stem cells, assure appropriate oversight, and
bring together the finest minds and facilities to further medical and scientific advances. Allow
me to assure you that the NIH understands and respects the deep convictions of people in the
research, academic and religious communities, and in Congress, and intends to seek the advice
and comment of those communities as we move ahead. I look forward to working with you to
ensure that the legal and ethical issues involved in this extremely promising area of research are
addressed.
Sincerely,
Down E Shlol
Donna E. Shalala
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FEB-17-99 14:12 FROM:DHHS os 105 EX SEC
Hnited States Senate
WASHINGTON, DC 20510
February 12, 1999
The Honorable Donna E. Shalala
The Department of Health and Human Services
200 Independence Avenue, SW
SPECIAL
Washington, D.C. 20201
Dear Secretary Shalala:
We are deeply concerned with what appears to be a unilateral attempt on your part to effectively
undermine congressional intent, by circumventing the current federal funding ban on embryo
research.
Of particular concern to us is testimony Dr. Varmus gave on January 26, 1999, during a hearing
before the Appropriations Subcommittee on Labor, Health and Human Services and Education.
During Dr. Varmus' testimony he stated, "Dr. Thomson and his co-workers derived pluripotent
stem cells from the blastocyst stage of an early embryo- the embryos used were donated by
couples who were receiving infertility treatment; this derivation of stem cells from the embryo
does fall under the ban on Federal funding." The contention being made is that once the stem
cells are derived, federal funding of research which directly relies on such destruction is
acceptable. We disagree.
Also of concern to us is Dr. Varmus' response to a statement by some researchers that human
pluripotent stem cells may come together in culture to begin developing as an embryo. If this
does occur, then NIH would be directly violating the congressionally imposed ban by funding
embryonic stem cell research. Dr. Varmus stated that he was unsure if it does occur, and that it
would be "grossly unethical" to try to find out because that would involve implantation. If the
director of the National Institutes of Health is unsure, then the proper course of action would be
to take no action. Better to em on the side of preserving congressional intent than destroying it.
Congress never intended for the National Institutes of Health to give incentives for the killing of
human embryos for the purpose of stem cell research. We are very interested in any further
insight you might provide on this issue and look forward to hearing from you soon.
Sincerely,
In Nickled
99FEB17 All 9:53
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Donkul
Bob Smith
JOH KyL
Jesse Helms Midael
Michael
John amount
SPECIAL
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THE SECRETARY OF HEALTH AND HUMAN SERVICES
WASHINGTON, D.C. 20201
The Honorable Don Nickles
MAR
2 1999
United States Senate
133 Hart Senate Office Building
Washington, DC 20510
Dear Senator Nickles:
Thank you for your letter dated February 11, 1999, concerning the recent announcement by the
Director of the National Institutes of Health (NIH) regarding federal funding for research
utilizing human pluripotent stem cells. As you know, this research has the potential to lead to
great progress in our treatment of debilitating and deadly diseases, our understanding of human
development and our ability to develop and test new drugs. Stem cell research is richly
promising, yet raises important ethical issues. Therefore, Dr. Varmus and his colleagues at the
National Institutes of Health (NIH) will proceed with great caution to ensure that the highest
standards are set before moving forward in this area.
In keeping with the significant ethical concerns that must be considered, the NIH plans to
proceed in a careful and deliberate fashion to develop rigorous guidelines. A working group of
the Advisory Committee to the Director of NIH will develop guidelines for the conduct of
research using pluripotent stem cells and will recommend an oversight mechanism for protocol
review. The National Bioethics Advisory Commission is studying these issues and will provide
us with advice that - together with counsel from outside experts, Congress and the public - will
help ensure appropriate oversight.
First and foremost, these guidelines will ensure that any research funded in this area is consistent
with the prohibition on federal funding for human embryo research contained in section 511 of
the HHS appropriations law. Since this prohibition was first enacted in 1996, the Department of
Health and Human Services (HHS) has conscientiously adhered to its strictures. For example,
we have included the restriction on the use of funds in the NIH Grants Policy Statement and have
issued notices reminding NIH intramural staff and the extramural research community that they
must observe the prohibition. When necessary, we have not and will not hesitate to take
appropriate enforcement action. I am firmly committed to our continued adherence to this law.
You have asked whether pluripotent stem cells may come together in culture to begin developing
as an embryo. The scientific knowledge base about pluripotent stem cells comes from years of
experience in animal research. Mouse pluripotent stem cells grown in a petri dish can give rise to
specialized cells and tissues which sometimes form an aggregated structure, similar to certain
tumors of the ovary and testis, termed an "embryoid body." These mouse embryoid bodies,
however, are not embryos. Similarly, in one report on the derivation of human pluripotent stem
cells, researchers observed that the human pluripotent stem cells can form embryoid bodies that
are similar in structure to mouse embryoid bodies, which, as noted above, are not embryos.
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I have reviewed our Department's position and am reassured that proceeding cautiously with
research on existing pluripotent stem cell lines is both legal and appropriate. Further, it will
allow the NIH to foster world-class research on stem cells, assure appropriate oversight of such
research, and bring together the finest minds and facilities to further medical and scientific
advances. I assure you that the NIH understands and respects the deep convictions of people in
the academic, religious and bioethics communities, and in Congress, and intends to seek the
advice and comment of those communities as we move ahead. I look forward to working with
you to ensure that the legal and ethical issues involved in this extremely promising area of
research are addressed.
GS Donna E. Shalala
Sincerely,
MAR-02-1999 17:58
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P.03
Congress of the United States
Mashington, DC 20515
SPECIAL
March 15, 1999
The Honorable Donna E. Shalala
WIRDL CENTER
Secretary of Health and Human Services
99 HAR 16 PH 4:32
200 Independence Avenue, S.W.
Washington, D.C. 20201
Dear Madam Secretary:
Thank you for responding so quickly to our February 11 letter concerning federal funding
of research in which human embryos are destroyed. Unfortunately, your letter was not responsive
to our concerns but only raises further questions.
Consequently, we once again are compelled to point out that well-established rules of
statutory construction have been ignored by the HHS General Counsel's memorandum
reinterpreting current law on embryo research. The Supreme Court of the United States, as we
noted in our earlier correspondence, has ruled that two parallel clauses of a law may not be
interpreted in the same way if Congress expresses one provision narrowly and the other broadly.
Had Congress intended only to ban the use of funds for the specific act of destroying or
discarding embryos, Congress would have done that. Instead, Congress prohibited funding of
"research in which" embryos are destroyed or discarded. For this reason, your contention that
"the plain language of the statute supports the opinion issued by the General Counsel" remains
unconvincing.
In fact, your conclusion that the ban was not intended to cover "research preceding or
following" such destruction contradicts NIH's own policy and practice ever since the funding ban
was first enacted. In 1997, for example, researcher Mark Hughes was found to be in violation of
this law and dismissed from NIH. His violation was that he had used NIH-funded equipment to
analyze genetic material obtained from human embryos. NIH funds were used in research which
followed the harvesting of a cell from an embryo; in cases where a genetic defect was found, the
analysis may also have preceded the discarding of an embryo. There was never any indication
that the NIH equipment was used to destroy embryos. Yet in testimony before the House
Commerce Subcommittee on Oversight and Investigations on June 19, 1997, NIH Director
Harold Varmus agreed that the ban had been violated and he assured Congress that NIH had
taken "several steps to further diminish the risk of subsequent violations." Now HHS proposes
that these types of violations become the norm.
We would also point out that the context in which the funding ban was enacted supports
NIH's enforcement of the law from its enactment in January 1996 until Dr. Varmus's
announcement in January 1999. Congress passed the law in response to a 1994 report from the
NIH Human Embryo Research Panel. The panel recommended taxpayer support of "research
involving the development of embryonic stem cells" as part of its recommendations on funding of
PRINTED ON RECYCLED PAPER
8
The Honorable Donna E. Shalala
page two
"various areas of research involving the ex utero preimplantation human embryo." The panel
treated embryonic stem cell research as a form of embryo research because it knew that the cells
would have to be obtained by destroying embryos. When Congress rejected the recommendations
of the NIH panel by enacting the current funding ban, it did not make any exceptions. It rejected
this form of experimentation as well.
In this context, it is remarkable that your February 23 letter proposes the Advisory
Committee to the Director of NIH as the body that will ensure respect for ethical and legal standards
in this research. This committee unanimously endorsed the original recommendations of the
Human Embryo Research Panel - including proposals for special creation of embryos for research
purposes that were immediately rejected by President Clinton. This same committee openly
planned a lobbying campaign to prevent Congress from enacting the ethical protections that remain
in law today. Thus we are more concerned than ever that HHS's current course is less a good-faith
interpretation of the law than an attempted end-run by those who have always opposed the law.
With regard to the definition of human embryo', we are not troubled at all by HHS's use of a
scientific definition of the word "organism." As the HHS General Counsel rightly states, an
"organism" includes any "individual constituted to carry out all life functions," including a one-
celled individual. Rather, we are troubled by the paragraph in which she completely ignores this
definition and states that "a human embryo, as that term is virtually universally understood, has the
potential to develop in the normal course of events into a living human being." Ms. Rabb declares
on behalf the Department, with an appeal to no authority in science or law, that virtually no one
considers a human embryo to actually be a living human being. This position simply contradicts the
definitions which Ms. Rabb used a few lines before this in her memo to establish that a human
embryo is an organism, and, as such, is an "individual constituted to carry out all life functions" of a
human being. In other words, an embryo is a human being.
Ms. Rabb's statement that certain cells "do not have the capacity to develop into a human
being, even if transferred to a uterus" leaves a doubt in our mind as to the point in biological
development when Ms. Rabb considers a "human being" to come into existence, or whether she
considers any child before birth to be a "human being." This is not an insignificant point. If the
potential or capability of something "to develop into a living human being" is the standard used to
determine whether an organism is a human embryo, and HHS does not consider a "human being" to
exist before live birth, then the entire law on embryo research, as well as President Clinton's
directive against special creation of research embryos, is undermined. Scientists have already
offered to conduct their destructive experiments on damaged embryos not expected to survive to
live birth, or to engineer lethal defects into embryos in advance, so that the human embryos they
create for purposes of destructive research will not legally be "embryos" at all.
I Current law provides that, "For purposes of this section, the term 'human embryo or
embryos' include any organism, not protected as a human subject under 45 CFR 46 as of the date
of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any
other means from one or more human gametes or human diploid cells."
The Honorable Donna E. Shalala
page three
This new and arbitrary use of the term "human being" also contradicts the entire history of
federal regulations on human experimentation which, since 1975, have treated the child in the
womb at every stage of development as a "human subject" to be protected from harmful research.
In commissioning studies of ethical issues in genetics, Congress has urged respect for "the
essential equality of all human beings, born and unborn" (42 USC 300v-1). Clearly, in science
and law, a human embryo has no need to "develop into" a human being because it already is a
human being. The fact that a particular embryo may ultimately have a longer or shorter life span
is irrelevant in this regard. It would be akin to HHS claiming that a seriously ill infant is not really
an infant because he or she most likely will not "develop into" a live adult.
Even if HHS's arbitrary definition were valid, the General Counsel's statement that
pluripotent stem cells "do not have the capacity to develop into a human being, even if transferred
to a uterus" is open to question. On January 26, Dr. Varmus testified that he does not know
whether these stem cells may sometimes recongregate in culture to begin developing as a human
embryo. He added that it would be "grossly unethical" to transfer these cells into a woman's
uterus to try to answer this question. Would it not also be grossly unethical to simply ignore this
question and pursue such embryonic stem cell research, particularly if NIH admits that it may
violate the law?
Finally, your letter makes no reference to the precedent established by current law on the
use of fetal tissue from induced abortions. Under this law, which also specifically covers cells and
tissue obtained from embryos, the harvesting procedure itself must not destroy prenatal life, and
the timing and method for taking life must not be influenced solely by the needs of the federally
funded research project. These principles are violated by the Administration's proposal for stem
cell research.
Madam Secretary, because these are complex and important issues, we urge you once
again to address our very serious concerns. For three years the ban on taxpayer funding of
harmful research involving human embryos was enforced clearly and appropriately. The change in
policy proposed by Dr. Varmus, based on the faulty reasoning in your General Counsel's memo,
would violate the funding ban and mark a tragic step backward in federal standards for research
involving human subjects.
Sincerely,
Celuir Smith
Dadich
9
page four
Mil Rhall
Dont Mathsh
Bot-May
Pete
Rete sessions
Steve Largest
Jack Metcalf
Barbara Culin
John Hostetter
John T.Daritte
David D. Philse
Dan Buton KimBanny Rick J Lill Brooy
Vigil Doobe
The Honorable Donna E. Shalala
page five
In Rey
Heen
Mark Souder Ron Paul
Rondevis
he Myinl
Phil Craue John E Peterson
Jim Rynn
Tom Dehay
Pite King
Donald A. Mangullo
Cly Rhy
Tost Tiahet
for U.Colum Jim DeMint
page six
make Forber
Gay smille Phil English
Clos T. Comely Orman Huns
Hing Hyde Jue Barton
Asnual rhun Tan Tancudo
As Hulchn Shm charaí
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MA
Ray Blunt
The Honorable Donna E. Shalala
page seven
Garl Ryan
SPECIAL
03-16-99-0062
11
Congress of the United States
Mashington, DC 20515
Statement of Members of the House of Representatives
to the Working Group of the Advisory Committee to
the Director of the National Institutes of Health
APRIL 8, 1999
When Dr. Harold Varmus announced in January that he would reverse current policy
and begin using taxpayer funds for research on stem cells taken from living human embryos, we
-- together with many of our colleagues -- wrote to Health and Human Services Secretary Donna
Shalala to protest. As the ban on such funding originated in Congress, and has been consistently
opposed by this Administration, we believe we have something to contribute to today's
proceedings, particularly with regard to the legality of Dr. Varmus's plan.
Put simply, any NIH action to initiate funding of research which relies on the mutilation
and destruction of human embryos would violate both the letter and spirit of the federal law
banning federal support for research in which human embryos are harmed or destroyed. We
believe the memorandum from HHS General Counsel Harriet Rabb to Dr. Varmus supporting the
claim that taxpayer funds may be used for experiments on embryonic stem cells is wrong.
Rather than providing guidance on how best to implement the law that Congress passed and the
President signed, the memorandum appears to be a carefully worded effort to justify
transgressing that law.
The General Counsel unilaterally narrows the meaning of "research in which a human
embryo or embryos are destroyed" and states that it prohibits only direct federal funding of the
specific act of destroying the embryo. While the act of destroying or injuring an embryo would
certainly be ineligible for federal funding, the law has a broader application. It also bars the use
of tax dollars to fund research which follows or depends upon the destruction of or injury to a
human embryo.
Congress could have structured paragraph (2) of subsection (a) of the law like paragraph
(1) and simply prohibited the use of funds for the destruction or discarding of human embryos.
We did not do that, and by well-established rules of statutory construction, HHS may not
construe the law's provision on "research in which" embryos are destroyed as narrowly as its
provision on the creation of embryos. The Supreme Court of the United States has ruled that two
parallel clauses of a law may not be interpreted in the same way if Congress expresses one
provision narrowly and the other broadly. Had Congress intended only to ban the use of funds
for the specific act of destroying or discarding embryos, Congress would have done that.
Instead, Congress prohibited funding of "research in which" embryos are destroyed or discarded.
1
In fact, the Secretary's conclusion that the ban was not intended to cover "research
preceding or following" such destruction contradicts NIH's own policy and practice ever since the
funding ban was first enacted. In 1997, for example, researcher Mark Hughes was found to be in
violation of this law and dismissed from NIH because he had used NIH-funded equipment to
analyze genetic material obtained from human embryos. NIH funds were used in research which
followed the harvesting of a cell from an embryo; in cases where a genetic defect was found, the
analysis may also have preceded the discarding of an embryo. There was never any indication that
the NIH equipment was used to destroy embryos. Yet in testimony before the House Commerce
Subcommittee on Oversight and Investigations on June 19, 1997, NIH Director Varmus agreed
that the ban had been violated, and he assured Congress that NIH had taken "several steps to
further diminish the risk of subsequent violations." Now NIH proposes that these types of
violations become the norm.
We would also point out that the context in which the funding ban was enacted supports
NIH's enforcement of the law from its first enactment in January 1996 until Dr. Varmus's
announcement in January 1999. Congress passed the law in response to a 1994 report from the
NIH Human Embryo Research Panel. The panel recommended taxpayer support of "research
involving the development of embryonic stem cells" as part of its recommendations on funding of
"various areas of research involving the ex utero preimplantation human embryo." The panel
treated embryonic stem cell research as a form of embryo research because it knew that the cells
would have to be obtained by destroying embryos. When Congress rejected the recommendations
of the NIH panel by enacting the current funding ban, it did not make any exceptions. It rejected
this form of experimentation as well.
Even members of the National Bioethics Advisory Commission (NBAC) criticized Ms.
Rabb's memo as "disingenuous" for attempting to draw a line between actually destroying
embryos for research purposes and using the cells derived from that destruction.
According to a news report, NBAC member Alex Capron, co-director of the Center for
Health Policy and Ethics at University of Southern California, was quoted as saying, "I don't
believe use and derivation can be separated." John Fletcher, a biomedical ethicist from the
University of Virginia expressed the belief that HHS and NIH were relying on an excessively
legalistic interpretation and said the legal argument "is not an ethical argument. It is an opinion
that use can be separated from derivation, as if derivation is not relevant." He continued, "As a
moral construct I think that is very weak and evasive." (Source: Washington FAX, March 4, 1999)
Dr. Varmus's plan and the Rabb memorandum also ignore the policy reflected in current
law on fetal tissue transplantation research using tissue from intentionally aborted children. While
that law is itself open to criticism, it at least bans the use of fetal tissue in federally funded research
if abortion was induced for the purpose of providing the tissue. Under current law, which also
specifically covers cells and tissue obtained from embryos, federal funds may not be used for fetal
tissue transplantation experiments following an abortion if the timing and method of the abortion
were altered solely for the purpose of providing usable tissue for research. Yet, in the embryonic
stem cell research which NIH proposes to fund, the timing, method and procedures for destroying
the embryonic child would be determined solely by the federally funded researcher's need for
usable stem cells.
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Finally, both Ms. Rabb's memorandum and Dr. Varmus's testimony before a Senate
subcommittee present a new definition of "human embryo" that would undermine both the
congressional funding ban on embryo research, and the President's own 1994 directive against
using federal funds to create human embryos for research purposes. Ms. Rabb states that "a
human embryo, as that term is virtually universally understood, has the potential to develop in
the normal course of events into a living human being." She declares on behalf the Department
of Health and Human Services, with an appeal to no authority in science or law, that virtually no
one considers a human embryo to actually be a living human being. This position simply
contradicts the definitions which Ms. Rabb used a few lines before this in her memo to establish
that a human embryo is an organism, and, as such, is an "individual constituted to carry out all
life functions" of a human being. In other words, an embryo is a human being.
The position that an entity is an "embryo" only if one can show that it is capable, if
implanted in the womb, of becoming a born "human being" has no support whatsoever in federal
law. Nevertheless, researchers are already offering to use damaged human embryos in their
destructive research, or even to engineer lethal defects in advance into the embryos they create
for such research, in order to take advantage of this Administration cover and ignore the
congressional and presidential directives altogether.
This new and arbitrary use of the term "human being" also contradicts the entire history
of federal regulations on human experimentation which, since 1975, have treated the child in the
womb at every stage of development as a "human subject" to be protected from harmful research.
In commissioning studies of ethical issues in genetics, Congress has urged respect for "the
essential equality of all human beings, born and unborn" (42 USC 300v-1). Clearly, in science
and law, a human embryo has no need to "develop into" a human being because it already is a
human being. The fact that a particular embryo may ultimately have a longer or shorter life span
is irrelevant in this regard. It would be akin to HHS claiming that a seriously ill infant is not
really an infant because he or she most likely will not "develop into" a live adult.
Even if HHS's arbitrary definition were valid, the General Counsel's statement that
pluripotent stem cells "do not have the capacity to develop into a human being, even if
transferred to a uterus" is open to question. On January 26, Dr. Varmus testified that he does not
know whether these stem cells may sometimes recongregate in culture to begin developing as a
human embryo. He added that it would be "grossly unethical" to transfer these cells into a
woman's uterus to try to answer this question. Would it not also be grossly unethical to simply
ignore this question and pursue such embryonic stem cell research, particularly if NIH admits
that it may violate the law?
For more than 20 years, Federal laws and regulations have protected the human embryo
and fetus from harmful experimentation at the hands of the Federal government -- regardless of
whether the embryo is "perfect" or damaged, wanted or unwanted, intended for abortion or
intended for live birth. This area of law has provided a bulwark against government's misuse
and exploitation of human beings in the name of medical progress. It would be a travesty for this
Administration to attempt to unravel this accepted ethical standard.
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We urge you to recommend that the Director rescind his decision to begin funding
research involving the manipulation and destruction of living human embryos and continue to
enforce the embryo research funding ban as Congress intended.
Respectfully,
The Honorable Jay Dickey, M.C.
The Honorable Christopher H. Smith, M.C.
The Honorable Rick Hill, M.C.
The Honorable Steve Largent, M.C.
The Honorable Ron Lewis, M.C.
The Honorable Kevin Brady, M.C.
The Honorable Mark E. Souder, M.C.
The Honorable Bob Ney, M.C.
The Honorable Gary G. Miller, M.C.
The Honorable Ron Paul, M.C.
The Honorable Tom A. Coburn, M.C.
The Honorable John T. Doolittle, M.C.
The Honorable Richard H. Baker, M.C.
The Honorable Bob Schaffer, M.C.
The Honorable Jim Ryun, M.C.
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