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Stem Cells 2007: Stem Cell Veto 2007 and Executive Order [1]
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Stem Cells 2007: Stem Cell Veto 2007 and Executive Order [1]
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Records of the Domestic Policy Council (George W. Bush Administration)
W. Karl Zinsmeister's Files
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2017-0029-F
[
]
Thursday, May 30, 2019
FOIA Marker
This is not a textual record. This FOIA Marker indicates that material has been removed
during FOIA processing by George W. Bush Presidential Library staff.
Domestic Policy Council
Zinsmeister, W. Karl - Subject Files
Location or
NARA Number:
FRC ID:
OA Number:
Stack: Row: Sect.: Shelf: Pos.:
Hollinger ID:
W
31
24
6
7
14303
88293
14062
14165
Folder Title:
Stem Cells 2007: Stem Cell Veto 2007 and Executive Order [1]
Withdrawn/Redacted Material
The George W. Bush Library
DOCUMENT
FORM
SUBJECT/TITLE
PAGES
DATE
RESTRICTION(S)
NO.
001
Handwritten Note
[Notes]
2
N.D.
P5;
002
Handwritten Note
[Notes]
1
N.D.
P5;
003
Briefing
Meeting on Embryonic Stem Cell Research
2
06/20/2007
P5;
004
Speech
Remarks on Stem Cell Veto and Executive Order
4
06/20/2007
P5; P6/b6;
005
Handwritten Note [Notes]
1
N.D.
P5;
006
Handwritten Note [Notes]
1
N.D.
P5;
007.
Briefing
PT Notes 6/18 S.C.
5
06/18/2007 P5;
COLLECTION TITLE:
Domestic Policy Council
SERIES:
Zinsmeister, W. Karl - Subject Files
FOLDER TITLE:
Stem Cells 2007: Stem Cell Veto 2007 and Executive Order [1]
FRC ID:
14303
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 PRA]
b(7) Release would disclose information compiled for law enforcement
purposes [(b)(7) of the FOIA]
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(8) Release would disclose information concerning the regulation of
2201(3).
financial institutions [(b)(8) of the FOIA]
b(9) Release would disclose geological or geophysical information
Deed of Gift Restrictions
concerning wells [(b)(9) of the FOIA]
A. Closed by Executive Order 13526 governing access to national
Records Not Subject to FOIA
security information.
B. Closed by statute or by the agency which originated the document.
Court Sealed - The document is withheld under a court seal and is not subject to
C. Closed in accordance with restrictions contained in donor's deed
the Freedom of Information Act.
of gift.
Page 1 of 3
2014-0503-F
This document was prepared on Thursday, May 30, 2019
2017-0029-F
Withdrawn/Redacted Material
The George W. Bush Library
DOCUMENT FORM
SUBJECT/TITLE
PAGES
DATE
RESTRICTION(S)
NO.
008
Draft
Expanding Approved Stem Cell Lines in Ethically
4
N.D.
P5;
Responsible Ways
009
Speech
Remarks on Stem Cell Veto and Executive Order
4
06/20/2007
P5; P6/b6;
010
Email
Two Year Stem Cell Goal - To: Joel Kaplan - From:
1
06/15/2007
P5;
Karl Zinsmeister
011
Draft
[Draft]
2
N.D.
P5;
012
Email
[Email] - To: Raul Yanes, et al. - From: Karl Zinsmeister
1
06/19/2007
P5;
0.13
Email
Stem Cell Speech - To: William McGurn, et al. - From:
1
06/08/2007
P5;
Karl Zinsmeister
COLLECTION TITLE:
Domestic Policy Council
SERIES:
Zinsmeister, W. Karl - Subject Files
FOLDER TITLE:
Stem Cells 2007: Stem Cell Veto 2007 and Executive Order [1]
FRC ID:
14303
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 PRA]
b(7) Release would disclose information compiled for law enforcement
purposes [(b)(7) of the FOIA]
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(8) Release would disclose information concerning the regulation of
2201(3).
financial institutions [(b)(8) of the FOIA]
b(9) Release would disclose geological or geophysical information
Deed of Gift Restrictions
concerning wells [(b)(9) of the FOIA]
A. Closed by Executive Order 13526 governing access to national
Records Not Subject to FOIA
security information.
B. Closed by statute or by the agency which originated the document.
Court Sealed - The document is withheld under a court seal and is not subject to
C. Closed in accordance with restrictions contained in donor's deed
the Freedom of Information Act.
of gift.
2014-0503-F
Page 2 of 3
This document was prepared on Thursday, May 30, 2019
2017-0029-F
Withdrawn/Redacted Material
The George W. Bush Library
DOCUMENT FORM
SUBJECT/TITLE
PAGES
DATE
RESTRICTION(S)
NO.
014
Email
FW: - To: Christopher Papagianis, et al. - From: Karl
1
06/15/2007
P5;
Zinsmeister
COLLECTION TITLE:
Domestic Policy Council
SERIES:
Zinsmeister, W. Karl - Subject Files
FOLDER TITLE:
Stem Cells 2007: Stem Cell Veto 2007 and Executive Order [1]
FRC ID:
14303
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 PRA]
b(7) Release would disclose information compiled for law enforcement
purposes [(b)(7) of the FOIA]
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(8) Release would disclose information concerning the regulation of
2201(3).
financial institutions [(b)(8) of the FOIA]
b(9) Release would disclose geological or geophysical information
Deed of Gift Restrictions
concerning wells [(b)(9) of the FOIA]
A. Closed by Executive Order 13526 governing access to national
Records Not Subject to FOIA
security information.
B. Closed by statute or by the agency which originated the document.
Court Sealed - The document is withheld under a court seal and is not subject to
C. Closed in accordance with restrictions contained in donor's deed
the Freedom of Information Act.
of gift.
2014-0503-F
Page 3 of 3
This document was prepared on Thursday, May 30, 2019
2017-0029-F
Stem Cell Information
*********
To - ###
FEDERAL POLICY
ANNOUNCEMENTS
*slond
Channels Home Research Topics NIH Human Pluripatent Stem Cell Registry Hum Pluriposens Stem Cell Registry FAQ's
THE LINE **** -
Frequently Asked Questions (FAQs)
#
**** ********
- -
1. Why has the name of the NIH Human Embryonic Stem Cell Registry been changed?
#
- AND
2. What is meant by the term "pluripatency"?
- Fully
3. What are the properties of pluripotent stem cells?
LIMITS BE
4. Where do pluripotent stem cells come from?
5, How did NIH determine what standards should be used to establish a call's pluripotancy?
6, What kinds of pluripotent cell lines will now be added to the National Institutes of Health Human Pluripotent Stem Cell Registry?
7. How will NIH determine what cell lines meet these standards?
**** :- Registry
B. How can a scientist get her or his pluripotent cell lines listed on the NIH Human Pluripotent Stem Cell Registry?
- - -
9. Does a cell line need to be listed on the NIH Human Pluripotent Stem Cell Registry in order to be eligible for Federal Funding?
I
10. Will NIH be distributing the human pluripotent stem cell lines listed on the new NIH Human Pluripotent Stem Cell Registry?
- the
11. What human subjects regulations and policies must I follow in order to have my pluripotent cell lines. whether derived from adult or fetal tissue listed on the NIH
- -------------------------
Human Pluripotent Stem Cell Registry?
-
12. What kind of information will help NIH determine it cell lines can be included on the N.H Human Pluripotent Stem Cell Registry?
13. Who will be reviewing information about your cell line?
the INSURED
MINES
-
1. Why has the name of the NIH Human Embryonic Stem Cell Registry been changed?
President George W. Bush required that the name of the registry be changed in his Executive Order #13435 (96. KB PDF; get Adobe Reader), issued on June
20, 2007, As a result of this Executive Order, the former National Institutes of Health Human Embryonic Stem Cell Registry will now be called the "National
Institutes of Health Human Pluripotent Stem Cell Registry." The registry will now include both human embryonic stem cells that were derived consistent with the
President's policy of August 9, 2001 and human pluripotent stem cells derived from non-embryonic sources.
2. What is meant by the term "pluripotency"?
Pluripotency is defined as the ability of stem cells to give rise to all of the various cell types that make up the body.
3. What are the properties of pluripotent stem cells?
Current scientific understanding of how to assess pluripotency is based on extensive studies of mouse embryonic stem (ES) cells. In mice, the gold standard test
for the ability to form derivatives of all three germ layers (ectoderm, mesoderm, and endoderm) is injecting putative pluripotent cells (labeled to permit tracking of
daughter cells) into a mouse blastocyst. If the injected cells are truly pluripotent, labeled daughter cells will be seen in tissues derived from all germ layers
throughout the embryo. This method, however, is not practical in non-human primates, nor ethical when it involves the use of human cells or blastocysts.
Consequently, scientists typically demonstrate the formation of all three germ layers by primate stem cells via teratoma formation. As our understanding of
pluripotency and its molecular characteristics advances, alternative methods are likely to be developed and accepted.
4. Where do pluripotent stem cells come from?
At present, scientists are able to derive human pluripotent stem cells from the inner cell mass of a 5-day-old pre-implantation blastocyst-stage embryo obtained
after in vitro fertilization; the cells derived in this manner are called human embryonic stem cells (hESCs). Recent publications report that scientists are now able
amniotic still
to reprogram human adult skin cells to behave in many respects like hESCs. These reprogrammed human adult skin cells are known as induced pluripotent stem
cells (iPSCs). Scientists continue to pursue additional ways to derive pluripotent human stem cells. NIH anticipates the need to continue to compare and evaluate
new and existing sources of human pluripotent stem cells.
5. How did NIH determine what standards should be used to establish a cell's pluripotency?
(Dirth trper
The characterization of stem cells and the definition of pluripotency are under active investigation by scientists today. NIH examined the current literature for: 1)
properties correlated with pluripotency; and 2) methods used to characterize human cells as pluripotent. The most commonly described properties were:
to keep alive)
Formation of a teratoma
Unlimited self-renewal in culture
Expression of a specific set of transcription factors (for example OCT4, SOX2, NANOG and POU5F1)
Expression of a unique set of cell surface markers (such as SSEA-3, SSEA-4, TRA-1-60, and TRA-1-81)
Formation of embryoid bodies
A specific pattern of gene expression assayed by whole genome profiling
A specific epigenetic profile
Two of these properties or methods were chosen as being most widely used and accepted as evidence of pluripotency: formation of a teratoma and unlimited
self-renewal in culture. In addition, derivers should provide information on the expression of the transcription factors and cell surface markers that are widely
used to characterize human pluripotent stem cells. NIH will update these criteria as additional and/or new standards are developed to establish pluripotency.
6. What kinds of pluripotent stem cell lines will now be added to the National Institutes of Health Human Pluripotent Stem Cell Registry?
Pluripotent cell lines derived from non-embryonic sources will be considered. Pluripotent cell lines derived from human embryos that meet the eligibility criteria
X
established by President George W. Bush on August 9, 2001 will also be considered. NIH will add cell lines to the new NIH Human Pluripotent Stem Cell Registry if
prob
derivers:
Provide evidence that cells from the proposed cell line form a teratoma that contains cells from all 3 embryonic germ layers (endoderm, mesoderm, and
This
dead
ectoderm). This method was chosen because it is currently the gold standard for determining whether a human line is pluripotent. If cells_from the line have
15
the
not been demonstrated to form a teratoma, the derivers may provide alternative evidence of pluripotentiality for consideration by the NIH
Provide evidence that the cell line is capable of unlimited self-renewal.
sponng For
ammoter,
7. How will NIH determine what pluripotent cell lines meet these standards?
The NIH Stem Cell Task Force has established a Pluripotency Standards Working Group that will evaluate submissions of cells and cell lines and assess them with
cord
respect to required properties. The Pluripatency Standards Working Group will also advise NIH on updating the criteria for establishing pluripotency as new
blood
science emerges. If appropriate, lines listed on the registry will be tested to determine that they meet the new standards.
B. How can a scientist get her or his pluripotent cell lines listed on the NIH Human Pluripotent Stem Cell Registry?
Scientists wishing to get their cell lines listed on the NIH Human Pluripotent Stem Cell Registry must submit evidence that their cells meet the minimum
requirements listed in FAQ consider the items mentioned in FAQ and have the lines approved by the NIH Pluripotency Standards Working Group.
9. Does a pluripotent cell line need to be listed on the NIH Human Pluripotent Stem Cell Registry in order for the research on it to be eligible for Federal
Funding?
Research using pluripotent stem cells derived from non-embryonic sources has been and continues to be eligible for Federal funds whether or not the cells are
listed on the Registry. The August 9, 2001 policy limitation applies specifically to pluripotent stem cells derived from human embryos. Therefore, research using
embryo-derived pluripotent stem cells is only eligible for Federal funding if it is listed on the NIH Human Pluripotent Stem Cell Registry.
10. Will NIH be distributing the human pluripotent stem cell lines listed on the new NIH Human Pluripotent Stem Cell Registry?
No, these lines remain the property of the scientists and/or institutions that generated them. Scientists wishing to obtain these cells for their expériments should
contact the Principal Investigator listed on the Registry.
11. What human subjects regulations and policies must I follow in order to have my pluripotent cell lines, whether derived from adult or fetal tissue, listed on
the NIH Human Pluripotent Stem Cell Registry?
Certain Federal regulations and policies may apply to the derivation of pluripotent cell lines from adult or fetal tissue. The Department of Health end Human
Services (HHS) regulations for the protection of human subjects at 45 CFR part 46 apply to non-exempt human subjects research that is conducted or supported
by HHS, and also may apply to non-exempt human subjects research that is performed at an institution that has agreed to apply HHS regulations to all of its
human subjects research through its assurance of compliance with the Office for Human Research Protections (OHRP). The Food and Drug Regulations at CFR
parts 50 and 56 generally apply to biomedical research involving an unapproved drug, device or biologic and may apply to certain studies of approved products.
Additional information on FDA regulations is available at http://www.accessdata.fda.gov/scrpts/cdrh/cfdocs/cffr/cfrsearch.fm The Health Insurance Portability
and Accountability Act (HIPAA) Privacy Rule at 45 CFR 160 and 164 Subparts A and E may also apply to certain health information used for research.
Investigators deriving pluripotent cell lines should consult their institutional review boards (IRBs) and/or Privacy Boards for specific guidance about whether and
how Federal, state and local regulations and policies apply to their work. Additionally, since some of the same regulations and policies may apply to the use of the
cell line for subsequent research, guidance about these requirements and later use of these cell lines should be sought from the local IRB and/or Privacy Board.
HHS Regulations:
Research involving the derivation of pluripotent cell lines from non-embryonic sources that is conducted or supported by the HHS or performed at an institution
that has agreed to apply the HHS regulations to all of its human subjects research through its assurance of compliance with OHRP may be subject to the HHS
regulations for the protection of human subjects CFR part 46). The requirement for IRB review for derivation of the cell lines depends on whether the research
involves human subjects, and if 50, whether the human subjects research is exempt under 45 CFR 46.101(b). The HHS regulations for the protection of human
subjects only cover human subjects research that is not exempt.
The HHS human subjects regulations define a human subject as follows:
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains
1. Data through intervention or interaction with the individual, or
2. Identifiable private information.
When using stored tissue or cells that were not collected specifically for the proposed derivation of pluripotent cell lines through an interaction or intervention
with a living individual, and that retain no links to the identity of the individual from whom the tissue or cells were originally obtained, the derivation of the cell line
is not considered human subjects research under the HHS regulations. Therefore, IRB approval and informed consent would not be required for the derivation of
the cell line.
When using stored tissue or cells from a deceased donor, the derivation of the cell line would not be considered human subjects research under the HHS
regulations because those regulations apply only to living individuals. However, state or local laws may apply (e.g., if material is obtained from autopsy).
When using stored tissue or cells that can be linked by the investigators to the identity of the individual from whom the tissue was obtained, the derivation of the
cell line constitutes human subjects research under the HHS regulations. However, such human subjects research may be exempt under 45 CFR 46.101(b).
Specifically, the exemption at 45 CFR 46.101(b)(4), which pertains to certain research involving the collection or study of existing data or specimens. may be
applicable. If the derivation of the cell line involves non-exempt human subjects research, then IRB review and approval and informed consent would be required
from the subject, unless the IRB determines that the criteria for a waiver of informed consent have been met. However, the derivation of the cell line may not
constitute human subjects research if the stored tissues or cells are coded and certain other conditions are met. See the HHS Office for Human Research
Protections (OHRP) Guidance on Research Involving Coded Private Information or Biolodical Specimens, August 10, 2004.
When tissues or cells for cell line derivation are obtained specifically for the proposed derivation of pluripotent cell lines through an interaction or intervention with
a living individual, IRB review is required and informed consent must be obtained, unless the IRB waives the requirement for obtaining informed consent in
accordance with the requirements of the HHS regulations at 45 CFR 46.116(d).
When using tissues or cells from human fetal tissue, federal regulations (e.g. 45 CFR part.46 the FDA human subjects regulations, and/or the HIPAA Privacy Rule)
and state and local laws must be followed, where applicable. In addition, Sections II. B. and Section III of the NIH Guidelines for Research Using Human
Pluripotent Stem Cells also apply.
OHRP information on how the HHS human subjects protection regulations apply to cells and specimens used for research is provided in:
Guidance for Investigators and Institutional Review Boards Regarding Research Involving Human Embryonic Stem Cells, Germ Cells and Stem Cell-Derived
Test Articles, March 19. 2002(37. KB PDF; get Adobe Reader)
Guidance on Research Involving Coded Private Information or Biological Specimens, August 10, 2004(23.7 KB PDF; get Adobe Reader)
The Health Insurance Portability and Accountability Act (HIPAA) Standards for Privacy of Individually Identifiable Health Information (Privacy Rule) 45 CFR 160 and
164 Subparts A and E does not apply to specimens or cells per se, but may apply to information about individuals that is associated with the specimen or cells.
The full text of the Privacy Rule can be found at the HIPAA Privacy Website of the Office for Civil Rights (OCR). Additional information about the Privacy Rule and
research is available on the NIH Privacy Rule website.
NIH Recombinant DNA Guidelines:
If the derivation of your pluripotent cell line involves recombinant DNA, you should consult the NIH Guidelines for Research Involving Recombinant DNA Molecules
to determine whether they apply. The Guidelines are available for download at http://www4.od.nih.gov/oha/rac/quidelines/ouidelines.html
12. What kind of information will help NIH determine if cell lines can be included on the NIH Human Pluripotent Stem Cell Registry?
For NIH to determine if your cell lines can be included on the Human Pluripotent Stem Cell Registry, NIH would be interested in knowing the following information:
Cell Line Information
Cell line name or identifier
Detailed protocol of derivation process and source of cell line
Individual or institution who derived the cell line
Individual or institution who owns the cell line
Any published, peer-reviewed scientific journal article that includes experiments demonstrating the pluripotency of the human cell type or line being
considered for inclusion on the NIH Human Pluripotent Stem cell Registry
Cell Characteristics
Whether feeder cells were used during the isolation and the source of the feeder cells
Passage number of the cell line
Whether the cell line had normal or abnormal karyotype and the abnormality
Whether the cells exhibit any of the following markers: SSEA-1, SSEA-3, SSEA-4, TRA-1-60, TRA-1-81, Oct-4, Alkaline Phosphatase, Nanog
Whether a DNA fingerprint analysis of the cell line was performed
Demonstration of Pluripotency
Whether or not your cells demonstrated the ability to give rise to a teratoma, ectoderm, mesoderm, endoderm, or other tissue type
Demonstration of Self Renewal
Whether your cell line is capable of dividing to produce more undifferentiated stem cells in culture, and the number of cell divisions the line has undergone
13. Who will be reviewing information about your cell line?
NIH Stem Cell Task Force
Human Pluripotent Stem Cell Registry Committee
31 Center Drive, Room 3C27, MSC (2320)
Bethesda, Maryland 20892-2320
Phone: 301-402-2313
Fax: 301-402-2265
E-mail: [email protected]
Uo to Top
4.
The <<<<<<<<
and e
OF
USA.gov
Bush Will Pair Veto With New Cell Initiative
By SHERYL GAY STOLBERG
tached - and some scientists were
tients have been pressing Mr. Bush
WASHINGTON, June 19 - Presi-
instantly skeptical. Two leading
to lift those restrictions. On Tuesday,
dent Bush will issue an executive or-
stem cell researchers, interviewed
two senior administration officials,
der intended to encourage scientific
Tuesday evening, said the recent
speaking anonymously because the
advances in regenerative medicine,
work was no substitute for embryon-
president had not yet announced his
according to senior White House offi-
ic stem cell research. One, Douglas
new initiative, summoned a reporter
cials who said Mr. Bush would an-
A. Melton of Harvard University,
to the White House to share details of
said he had become aware recently
the alternative plan.
nounce the initiative on Wednesday,
that the White House was trying to
They said the initiative had three
just as he vetoes a measure promot-
reach out to some of his colleagues
parts.
ing embryonic stem cell research.
The embryonic stem cell measure
who are pursuing the skin cell re-
First, Mr. Bush will an announce
has widespread public support, and
search, which has not been replicat-
that the registry of embryonic stem
ed in humans.
cell lines eligible for research with
the veto would be the second time
federal tax dollars will be reconfig-
Mr. Bush has rejected it. By pairing
"It should be pursued just as ac-
ured as the "human pluripotent stem
the veto with a new scientific initia-
tively as we pursue human embryon-
cell registry," a change intended to
tive, the White House clearly hopes
ic stem cell research," Dr. Melton
allow other types of stem cells to be-
to blunt the inevitable criticism that
said of the recent studies. "I'm not
come eligible for federal financing if
Mr. Bush will face from researchers,
trying to say there's nothing to this,"
they have the same properties as
advocates for patients and politi-
he continued, "but it doesn't need any
embryonic stem cells.
cians, including many in his own par-
special attention from the White
Mr. Bush will also order Michael
ty.
O. Leavitt, secretary of health and
In interviews on Tuesday, two sen-
human services, to "support alterna-
ior administration officials said Mr.
tive techniques," the officials said.
Bush would direct his health and hu-
Looking for avenues
He will instruct Mr. Leavitt to come
man services secretary to promote
up with a plan describing how scien-
research into producing cells with
less problematic than
tists and researchers who want to
properties akin to those of human
get new stem cell lines approved for
embryonic stem cells, without de-
embryonic stem cells.
the registry might do SO.
stroying embryos in the process. Mr.
The officials said the White House
Bush has said embryo destruction is
was particularly encouraged by sev-
a moral line that he will not cross.
eral new avenues of research, includ-
House. All we've ever asked is let hu-
The officials said Mr. Bush wanted
ing studies involving stem cells ob-
man embryonic stem cell research
the National Institutes of Health to
tained from amniotic fluid, and ef-
vie for public funding like all other
forts to extract stem cells from em-
capitalize on recent scientific ad-
research."
vances, including a study published
bryos that had been declared "clin-
Tony Fratto, deputy White House
ically dead."
this month involving skin cells in
press secretary, said the new initia-
But scientists said those studies
Preservation Copy
mice, that had the potential to side-
tive was "not about politics. It's
could be as ethically problematic as
step the ethical controversies sur-
about achieving effective policy."
the ones Mr. Bush already opposes.
rounding embryonic stem cell ex-
Controversy over human embry-
John Gearhart, a stem cell research-
periments. The White House has
onic stem cell studies has been a
er at Johns Hopkins University, said
been consulting with scientists in re-
theme in the Bush presidency. The
no one had figured out when an em-
cent weeks on the plan, they said.
cells are considered valuable be-
bryo could be declared clinically
"This is the product of a lot of real-
cause they are "pluripotent," mean-
dead. The White House officials said
ly hard, earnest work on this policy,"
ing they can develop into any type of
it would be up to the health institutes
said Karl Zinsmeister, a domestic
tissue in the body, and might there-
to develop standards.
policy adviser to Mr. Bush who
fore yield treatments and cures. In
"It is not an alternative for embry-
helped develop the initiative. "It is a
August 2001, Mr. Bush said he would
onic stem cell research, because
real sincere effort to open up a new
allow taxpayers to finance the re-
some of these alternative procedures
scientific solution to a vexing prob-
search, but only on stem cell colo-
still have ethical issues associated
lem."
nies, called lines, that already ex-
with them," Dr. Gearhart said, add-
But the effort appears largely
isted.
ing, "Who is the god that says the em-
symbolic - there is no money at-
Scientists and advocates for pa-
bryo is dead?"
THE WASHINGTON POST
Bush Moving to Bolster
Stem Cell Alternatives
Embryonic Harvesting Remains Off-Limits
By MICHAEL A. FLETCHER
"This disabuses us of this notion
and DAVID BROWN
that there is this fundamental con-
Washington Post Staff Writers
flict between science and ethics,"
Karl Zinsmeister, Bush's top do-
President Bush, under increas-
mestic policy adviser, said of the
ing pressure to relax his restric-
new research.
tions on embryonic stem cell re-
Scientists can receive federal
search, plans to issue an executive
funding only for work on embryon-
order today to encourage govern-
ic stem cells obtained from roughly
ment agencies to support research
20 colonies already in existence
that offers the promise of creating
when Bush's ban went into effect.
medically useful stem cells without
In his speech, Bush is expected to
destroying human embryos, ac-
express the hope that the recent ad-
cording to senior administration
vances will quickly expand the
officials.
number of cell colonies compatible
The order, which Bush plans to
with federal funding.
outline in a speech at the White
There is some evidence that cells
House today, would require the De-
with the capacity to divide and
partment of Health and Human
grow into many different tissues
Services to develop guidelines for
exist in the placenta, umbilical cord
funding alternative approaches
blood and bone marrow. Winnow-
over the next three months.
ing them from other cells and suc-
Bush is to issue his order as he
cessfully pushing them down a path
vetoes legislation that would loos-
toward medically useful purposes,
en his six-year-old restrictions on
however, has been difficult.
federal funding for embryonic stem
Part of the problem is that some
cell research. The bill passed by
of these "adult" stem cells are not
comfortable - but not veto-proof
as primitive and potent as those ex-
- margins in the House and Sen-
tracted from an embryo when it is
ate. Bush has opposed research
at the stage of a barely visible ball
with stem cells derived in a process
of cells.
that destroys human embryos,
This month, three research
which he calls immoral.
teams announced that they were
White House officials acknowl-
able to coax skin cells from mice to
edge that the executive order is
revert into more primitive and po-
less a change in policy than "a kick
tent cells - the equivalent of going
in the pants" for the government to
back in time. This raises the possi-
make clear that it is willing to fund
bility that everyone may possess
promising stem cell research. Re-
the raw material to make stem cells
cent advances have increased opti-
with the same therapeutic poten-
mism that stem cells with potential
tial as ones from embryos.
for treating diseases or even devel-
Other researchers recently
oping into human organs for trans-
showed they could make healthy
plants can be developed from skin
mouse stem cells from eggs with
cells, amniotic fluid or even cells
severe genetic abnormalities by re-
salvaged from dead embryos.
moving the damaged chromo-
The White House sees the
somes and putting in normal ones.
emerging research as a way out of a
If that could be done with some of
difficult and emotional debate.
the tens of thousands of chromo-
Shortly after becoming president,
somally abnormal fertilized eggs
Bush banned federal funding of
routinely discarded by fertility clin-
stem cell research that involves the
ics, it might be a source of ethically
destruction of human embryos,
acceptable embryonic stem cells,
which have long been seen as the
some experts believe.
most promising source of stem
But translating research from
cells. It was a position cheered by
lab to clinic, and from animals to
many conservative Christians and
humans, requires huge amounts of
others who equate embryos with
research. At least some of that
human lives.
work is what Bush apparently now
Opponents said the ban was
wants to support more vigorously.
slowing the pace of potentially life-
"The president supports and en-
saving research, which is now be-
courages stem cell research - in-
ing pursued with private and some
cluding using embryonic lines - as
state funding. In addition, oppo-
long as it does not involve creating,
nents said the embryos from which
harming or destroying embryos,"
stem cells are derived are slated for
said White House spokesman Tony
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BACKGROUND INFORMATION ON MEETING PARTICIPANTS
Dr. Tony Atala [AH-tall-ah], Director, Wake Forest Institute for Regenerative Medicine
(Winston-Salem, North Carolina)
Dr. Atala is a surgeon in the area of pediatric urology and a researcher in the area of regenerative
medicine and tissue engineering. His current work focuses on growing new human cells, tissues
and organs (including kidney, blood vessels, cartilage, muscle, bladder, pancreas, and others) to
repair or replace tissues or organs damaged by age, cancer, trauma, or abnormal development. In
January 2007, he led the team of researchers who first reported the isolation of pluripotent stem
cells from the amniotic fluid that surrounds developing embryos.
Dr. Bill Hurlbut [HERL-but], Professor of Neurology, Stanford Medical Center; Member,
President's Council on Bioethics (Stanford, California)
Dr. Hurlbut's main areas of interest involve the ethical issues associated with advancing
biotechnology and neuroscience, and the integration of philosophy of biology with theology.
Since 2002, he has served on your Council on Bioethics. He is the author of Altered Nuclear
Transfer, a proposed technological solution to the moral controversy over embryonic stem cell
research. This proposal would utilize the power of reprogramming and/or gene addition or
deletion in combination with basic nuclear transfer technology to 'directly produce pluripotent
stem cells without generating and subsequently destroying embryos.
Dr. Don Landry [LAYN-dree], Professor of Medicine, Columbia University Department of
Medicine; Director, Division of Nephrology, Columbia University Department of Medicine;
Director, Division of Clinical Pharmacology & Experimental Therapeutics, Columbia
University Department of Medicine (New York, New York)
Dr. Landry has worked as a NIH Physician-Scientists and his subspecialty training is in
Nephrology. In 1991 he established a laboratory at Columbia University to investigate medical
applications of artificial enzymes. His laboratory in Experimental Therapeutics focuses on
organic chemical solutions to intractable medical problems. Dr. Landry is one of the co-authors
of a research project that proposes to use and apply the ethical framework for obtaining essential
organs from deceased persons for transplantation to the harvesting of live stem cells from "dead
human embryos."
Message to the Senate of the United States
Page 1 of 2
THE WHITE HOUSE
CLICK HERE TO PRINT
PRESIDENT
GEORGE W. BUSH
For Immediate Release
Office of the Press Secretary
June 20, 2007
Message to the Senate of the United States
Fact Sheet: Advancing Stem Cell Research While Respecting Moral
Boundaries
White House News
Executive Order: Expanding Approved Stem Cell Lines in Ethically
Responsible Ways
TO THE SENATE OF THE UNITED STATES:
I am returning herewith without my approval S. 5, the "Stem Cell Research Enhancement Act of 2007."
Once again, the Congress has sent me legislation that would compel American taxpayers, for the first time in our
history, to support the deliberate destruction of human embryos.
In 2001, I announced a policy to advance stem cell research in a way that is ambitious, ethical, and effective. I
became the first President to make Federal funds available for embryonic stem cell research, and my policy did
this in ways that would not encourage the destruction of embryos. Since then, my Administration has made more
than $130 million available for research on stem cell lines derived from embryos that had already been destroyed.
We have also provided more than $3 billion for research on all forms of stem cells, including those from adult and
other non-embryonic sources.
This careful approach is producing results. It has contributed to proven therapeutic treatments in thousands of
patients with many different diseases. And it is opening the prospect of new discoveries that could transform lives.
Researchers are now developing promising new techniques that offer the potential to produce pluripotent stem
cells, without having to destroy human life -- for example, by reprogramming adult cells to make them function like
stem cells.
Technical innovation in this difficult area is opening up new possibilities for progress without conflict or ethical
controversy. Researchers pursuing these kinds of ethically responsible advances deserve support, and there is
legislation in the Congress to give them that support. Bills supporting alternative research methods achieved
majority support last year in both the House and the Senate. Earlier this spring another
bill supporting alternative research won overwhelming majority support in the Senate, and I call on House leaders
to pass similar legislation that would authorize additional funds for ethical stem cell research. We cannot lose the
opportunity to conduct research that would give hope to those suffering from terrible diseases and help move our
Nation beyond the controversies over embryo destruction. I invite policymakers and scientists to come together to
solve medical problems without compromising either the high aims of science or the sanctity of human life.
S. 5, like the bill I vetoed last year, would overturn today's carefully balanced policy on stem cell research.
Compelling American taxpayers to support the deliberate destruction
of human embryos would be a grave mistake. I will not allow our Nation to cross this moral line. For that reason, I
must veto this bill.
GEORGE W. BUSH
THE WHITE HOUSE,
June 20, 2007.
http://www.whitehouse.gov/news/releases/2007/06/print/20070620-5.html
6/20/2007
Executive Order: Expanding Approved Stem Cell Lines in Ethically Responsible Ways
Page 1 of 2
THE WHITE HOUSE
CLICK HERE TO PRINT
PRESIDENT
GEORGE W. BUSH
For Immediate Release
Office of the Press Secretary
June 20, 2007
Executive Order: Expanding Approved Stem Cell Lines in Ethically Responsible Ways
Message to the Senate of the United States
Fact Sheet: Advancing Stem Cell Research While Respecting Moral
White House News
Boundaries
By the authority vested in me as President by the Constitution and the laws of the UnitedStates of America,
and to provide leadership with respect to research on pluripotent stem cells derived by ethically responsible
techniques so that the potential of pluripotent stem cells can be explored without violating human dignity or
demeaning human life, it is hereby ordered as follows:
Section 1. Research on Alternative Sources of Pluripotent Stem Cells. (a) The Secretary of Health and Human
Services (Secretary) shall conduct and support research on the isolation, derivation, production, and testing of
stem cells that are capable of producing all oralmost allof the cell types of the developing body and may result in
improved understanding of or treatments for diseases and other adverse health conditions, butare derived without
creating a human embryo for research purposes or destroying, discarding, orsubjecting to harm a human embryo
or fetus.
(b) Within 90days of this order, the Secretary, after such consultation with the Director of the National
Institutes of Health (Director), shall issue a plan, including such mechanisms as requests for proposals, requests
for applications, program announcements and other appropriate means, to implement subsection(a) of this
section, that:
(i) specifies and reflects adetermination of the extent to which specific techniques may require additional
basic or animal research to ensure that any research involving human cells using these techniques is clearly
consistent with the standards established under this order and applicable law;
(ii) prioritizes research with the greatest potential forclinical benefit;
(iii) takes into account techniques outlined by the President's Council on Bioethics, and any other appropriate
techniques and research, provided they clearly meet the standard set forth in subsection(a) of this section;
(iv) renames the "Human Embryonic Stem Cell Registry" the 'Human Pluripotent Stem Cell Registry," and
(v) adds to the registry new human pluripotent stem celllines that clearly meet the standard set forth in
subsection (a) of this section.
(c) Not later than December 31 of each year, the Secretary shall report to the President on the activities carried
out under this order during the past fiscal year, including a description of the research carried out or supported by
the Department of Health and Human Services, including the National Institutes of Health, and other
developments in the science of pluripotent stem cells not derived from human embryos.
Sec. 2. Policy. The activities undertaken and supported by and under the direction of the Secretary shall be
clearly consistent with the following policies and principles:
(a) the purposes of this order are (i) to direct the Department of Health and Human Services, including the
National Institutes of Health, to intensify peer reviewed research that may result in improved understanding
ofortreatments for diseases and other adverse health conditions, and (ii) to promote the derivation of human pluri-
potent stem cell lines fromavariety of alternative sources while clearly meeting thestandard set forth insection 1(a).
http://www.whitehouse.gov/news/releases/2007/06/print/20070620-6.html
6/20/2007
Executive Order: Expanding Approved Stem Cell Lines in Ethically Responsible Ways
Page 2 of 2
of this order;
(b) it is critical to establish moral and ethical boundaries to allow the Nation to move forward vigorously
withmedical research, while also maintaining the highest ethical standards and respecting human life and human
dignity;
(c) the destruction of nascent life for research violates the principle that no life should be used as a mere
means for achieving the medical benefit of another;
(d) human embryos and fetuses, as living members of thehuman species, are not raw materials to be exploited
orcommodities to be bought and sold; and
(e) the Federal Government has a duty to exercise responsible stewardship of taxpayer funds, both supporting
important medical research and respecting ethical and moral boundaries.
Sec. 3. Interpretation of this Order. (a) For purposes of this order, the term "human embryo" shall mean
anyorganism, not protected as a human subject under 45 CFR 46 as of the dateof this order, that is derived by
fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid
cells.
(b) For purposes of this order, the term "subjecting to harm a human embryo" shall mean subjecting such an
embryo to risk of injury or death greater than that allowed for research on fetuses in utero under 45CFR 46.204(b)
and section498(b) ofthe Public Health Service Act (42U.S.C. 289g(b)) as of the date of this order.
(c) Nothing in this order shall be construed to affect anypolicy, guideline, or regulation regarding embryonic
stem cell research, human cloning by somatic cell nuclear transfer, or any other research not specifically
authorized by this order, or toforbid the use of existing stem cell lines deemed eligible forother federally funded
research in accordance with the presidential policy decision of August9, 2001, for research specifically authorized
by this order.
Sec. 4. General Provisions. (a) This order shall be implemented consistent with applicable law and subject to
the availability of appropriations.
(b) This order is not intended to, and does not, create any right, benefit, or privilege, substantive or procedural,
enforceable atlaw or in equity, by any party against the UnitedStates, itsdepartments, agencies, or entities, its
officers, employees, or agents, or any other person.
GEORGE W. BUSH
THE WHITE HOUSE,
June 20, 2007.
###
Return to this article at:
http://www.whitehouse.gov/news/releases/2007/06/20070620-6.htm
CLICK HERE TO PRINT
http://www.whitehouse.gov/news/releases/2007/06/print/20070620-6.html
6/20/2007
Page 1 of 2
Zinsmeister, Karl
From: Papagianis, Christopher C.
Sent:
Wednesday, June 20, 2007 3:38 PM
To:
Troy, Tevi D.; Zinsmeister, Karl
Cc:
Stefanik, Elise M.
Subject: FW: NRLC praises Bush veto and executive order on stem cell research
National Right to Life Commends President Bush
for Executive Order and Veto, Advancing Research While Respecting Human
Life
The following statement was released by the National Right to Life Committee (NRLC) in
Washington, D.C., on Wednesday, June 20, 2007, at 3 PM EDT. For further information,
send an e-mail to [email protected] or call 202-626-8820.
WASHINGTON (June 20, 2007) -- The National Right to Life Committee (NRLC) today
expressed strong approval of President Bush's veto of legislation (S. 5) that would
mandate federal funding of the type of stem cell research that requires the killing of
human embryos. NRLC also commended the President for issuing an executive order
to promote more federal funding for promising types of stem cell research that do not
require harming human embryos.
On June 7, House Speaker Nancy Pelosi (D-Ca.) said that "science has taken us to a
place that is biblical in its power to cure -- and that is the embryonic stem cell
research." NRLC Legislative Director Douglas Johnson commented, "Since not a single
human being has benefited from any procedure using embryonic stem cells, Pelosi's
statement is yet another demonstration that the congressional Democratic leadership is
more interested in demagoguery than in supporting the most promising types of stem
cell research, which do not require killing human embryos."
A close vote is expected in the Senate on whether to override the veto, which would
require the votes of two-thirds of the sworn senators who are present and voting. If the
Senate votes to override, S. 5 would return to the House of Representatives. The House
has already voted on the issue twice this year on January 11 (253-174, on passage of
H.R. 3, which is very similar to S. 5), and on June 7 (247-176, on passage of S. 5). There
were different absentees on each occasion, but every House member voted on at least
one of those two occasions, and if all House members had voted on June 7, the margin
of passage would have been 35 votes short of a two-thirds margin. Contrary to some
claims by Congresswoman Diana DeGette (D-Co.), there was no movement in either
direction between the January and June roll calls.
According to a report in Roll Call (June 20), Senators Tom Harkin (D-lowa) and Arlen
Specter (R-Pa.) also intend to insert language in the appropriations bill for the
Department of Health and Human Services, which they proclaim as a "compromise," but
6/20/2007
Page 2 of 2
which in reality would overturn the President's policy. NRLC's Johnson commented,
"Such grandstanding won't overturn the President's pro-life policy, but it could result in
the entire appropriations bill being vetoed." Indeed, the Roll Call article reports, "But
one Senate Democratic source said the addition of the stem-cell provision will help
divert attention from the price tag of the bill, which is expected to be far more expensive
than the president requested."
On May 3, President Bush sent Senate Majority Leader Harry Reid (D-Nv.) and House
Speaker Pelosi letters in which he said, "I will veto any legislation that weakens current
Federal policies and laws on abortion, or that encourages the destruction of human life
at any stage." More than one-third of the members of the House have signed a letter to
the President, pledging that they will vote to sustain such vetoes. To view or download
these letters, go to http://www.nrlc.org/press_releases_new/Release050307.html
To read NRLC's April 2 letter to House members in opposition to S.5, go to:
http://www.nrlc.org/killing_embryos/NRLCLettertoSenateS5andS30.html
To read a recent essay from National Review Online highlighting examples of widely
disseminated misinformation about embryonic stem cell research, click here.
For more information on human embryo research, human cloning, human fetus farming,
and related issues, see: http://www.nrlc.org/killing_embryos/index.html and
http://www.stemcellresearch.org/
If you do not wish to receive occasional updates from NRLC on issues such as this,
simply REPLY to this e-mail with the word REMOVE in the body of your reply. Thank
you.
See what's free at AOL.com.
6/20/2007
THE WHITE HOUSE
WASHINGTON
REMARKS ON EMBRYONIC STEM CELL RESEARCH
Wednesday, June 20, 2007
2:25 p.m. - 2:55 p.m.
East Room
Karl Rove / Candida Wolff / Karl Zinsmeister
I.
PURPOSE
To deliver remarks on your reasons for vetoing S. 5, which would encourage the
destruction of embryos for research and to outline recent advances in alternative stem cell
therapies.
II.
BACKGROUND
Your remarks follow your meeting with experts on embryonic stem cell research.
III.
PARTICIPANTS
Administration Officials
Secretary Mike Leavitt, Department of Health and Human Services
Admiral John Agwunobi, Assistant Secretary, Department of Health and Human Services
Members of Congress
Senator Norm Coleman (R, MN)
Senator Saxby Chambliss (R, GA)
Senator Johnny Isakson (R, GA)
Minority Leader John Boehner (R, OH-08)
Congressman Chris Smith (R, NJ-04)
Congressman Roscoe Bartlett (R, MD-06)
Congressman Dave Weldon (R, FL-15)
Congressman Joe Pitts (R, PA-16)
Congressman Randy Forbes (R, VA-04)
Congressman Mike Pence (R, IN-06)
Congressman Trent Franks (R, AZ-02)
Congressman Phil Gingrey (R, GA-11)
Congresswoman Marsha Blackburn (R, TN-07), and daughter Mary Morgan Ketchel
Congressman Charles Boustany (R, LA-07)
Congressman Jeff Fortenberry (R, NE-01), and wife Celeste Gregory
Congressman Dan Lungren (R, CA-03)
Stage Participants
Carol Franz, Stem Cell Patient; Retired; Former Employee, IBM Corporation (Oswego,
New York)
Dr. Bill Hurlbut, Professor of Neurology, Stanford Medical Center; Member, President's
Council on Bioethics (Stanford, California)
Note: Dr. Hurlbut will participate in the meeting on embryonic stem cells in the Oval
Office prior to your remarks.
Dr. Don Landry, Professor of Medicine, Columbia University Department of Medicine;
Director, Division of Nephrology, Columbia University Department of Medicine;
Director, Division of Clinical Pharmacology & Experimental Therapeutics, Columbia
University Department of Medicine (New York, New York)
Note: Dr. Landry will participate in the meeting on embryonic stem cells in the Oval
Office prior to your remarks.
Kaitlyne [Kate-Lynn] McNamara (age 18), Stem Cell Patient, and father Mike, mother
Tracy, and brother Ian (age 16) (Middletown, Connecticut)
White House Staff Attending
Tony Snow, Press Secretary
Karl Zinsmeister, Assistant to the President for Domestic Policy
Jay Hein, Deputy Assistant to the President and Director of the Office of Faith-Based
Community Initiatives
Working Contacts
Matt Shilling, Associate Director, Office of Public Liaison
Elise Stefanik, Executive Assistant, Domestic Policy Council
IV.
PRESS PLAN
Open
)
V.
SEQUENCE OF EVENTS
You arrive into the Blue Room and are met by Carol Franz and Kaitlyne, Mike, Tracy,
and Ian McNamara (2 clicks).
Note: The greeters will be escorted onto the stage with Dr. Hurlbut and Dr. Landry.
You are announced into the East Room and proceed to the podium.
You deliver remarks.
Upon conclusion of your remarks, you depart.
VI.
REMARKS
Provided by Speechwriting
VII.
ATTACHMENT
Background Information of Stage Participants
BACKGROUND INFORMATION ON STAGE PARTICIPANTS
McNamara Family (Middletown, Connecticut)
Kaitlyne [Kate-Lynn], stem cell patient (18 years)
Tracy, mother
Mike, father
Ian, brother (age 16)
Kaitlyne McNamara was born with spina bifida, as well as a diseased bladder. She failed all
medical therapy and her kidneys were at risk of failing (due to her high bladder pressures).
Doctors took a small piece of her bladder, less than half the size of a postage stamp, isolated her
bladder-specific normal stem cells, expanded their number, and then used them to cover a
bladder-shaped mold in the laboratory. The cells formed new bladder tissue that was then
implanted back into Kaitlyne. The organ was made with her own cells, so there was no rejection.
She is now benefiting from her new bladder and her kidneys are no longer at risk. Kaitlyne, 18,
will be joined on stage by her parents and her 16-year-old brother.
Carol Franz, Stem Cell Patient; Retired; Former Employee, IBM Corporation (Oswego, New
York)
In December 2002, Carol was diagnosed with an aggressive form of multiple myeloma cancer.
After six months of chemotherapy, Carol received an adult stem cell transplant from the cells in
her own blood stream. After her transplant, Carol's immune system strengthened significantly
and for three years, she was cancer free. In May 2006, Carol learned that the cancer had returned
and she underwent additional treatment, including another adult stem cell transplant. Today, her
cancer is once again in full remission. Carol has done numerous press interviews and has
traveled the country to share her story.
Dr. Bill Hurlbut, Professor of Neurology, Stanford Medical Center; Member, President's Council
on Bioethics (Stanford, California)
Dr. Hurlbut's main areas of interest involve the ethical issues associated with advancing
biotechnology and neuroscience, and the integration of philosophy of biology with theology. He
has served on your Council on Bioethics since 2002. He is the author of Altered Nuclear
Transfer, a proposed technological solution to the moral controversy over embryonic stem cell
research. This proposal would utilize the power of reprogramming and/or gene addition or
deletion in combination with basic nuclear transfer technology to directly produce pluripotent
stem cells without generating and subsequently destroying embryos.
Note: Dr. Hurlbut will participate in the meeting on embryonic stem cells prior to your remarks.
Dr. Don Landry, Professor of Medicine, Columbia University Department of Medicine;
Director, Division of Nephrology, Columbia University Department of Medicine; Director,
Division of Clinical Pharmacology & Experimental Therapeutics, Columbia University
Department of Medicine (New York, New York)
Dr. Landry has worked as a NIH Physician-Scientist and his subspecialty training is in
Nephrology. In 1991, he established a laboratory at Columbia University to investigate medical
applications of artificial enzymes. His laboratory in Experimental Therapeutics focuses on
organic chemical solutions to intractable medical problems. Dr. Landry is one of the co-authors
of a research project that proposes to use and apply the ethical framework for obtaining essential
organs from deceased persons for transplantation to the harvesting of live stem cells from "dead
human embryos."
Note: Dr. Landry will participate in the meeting on embryonic stem cells prior to your remarks.
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Advancing Stem Cell Research While Respecting Moral Boundaries
President Bush Takes Action To Support Ethical Research, Vetoes Bill Overturning Balanced Stem Cell Policy
Today, President Bush Signed An Executive Order To Strengthen Our Nation's Commitment To Research On
Pluripotent Stem Cells. Scientists have recently shown they have the ingenuity and skill to pursue the potential benefits of
pluripotent stem cell research - research on cells that have the potential to develop into nearly all the cell types and tissues
in the body - without endangering human life in the process. By expanding support for non-destructive research methods,
this Executive Order will make it more likely that these exciting advances continue to unfold.
President Bush Also Vetoed A Bill That Would Overturn His Careful, Ethical Approach To Stem Cell Research.
If this legislation became law, it would compel American taxpayers - for the first time in our history - to support the
deliberate destruction of human embryos. The President has made it clear to Congress and the American people that
he will not allow the Nation to cross this moral line.
In August 2001, President Bush Announced A Policy To Advance Stem Cell Research In A Way That Is Ambitious,
Ethical, And Effective. President Bush was the first president to make Federal funds available for human embryonic stem
cell research - and his policy did this in ways that would not encourage the destruction of embryos.
The President Believes We Must Pursue The Possibilities Of Science In A Manner That Respects Human
Dignity And Upholds Our Moral Values. Destroying human life in the hopes of saving human life is not ethical, and it
is not the only option before us. Technical innovation in this difficult area is opening up new possibilities for progress
without conflict or ethical controversy.
The President's Careful Approach Is Producing Results. Since 2001, the Administration has made $130 million
dollars available for research on stem cell lines derived from embryos that had already been destroyed before the
President's policy was announced. It has also provided more than $3 billion in Federal funding for research on all forms of
stem cells, including those from adult and other non-embryonic sources. This funding has contributed to proven
therapeutic treatments in thousands of patients with many different diseases, and it is opening the prospect of new
treatments and cures that could transform countless lives.
Recent Scientific Breakthroughs Are Showing Stem Cell Science Can Progress While Respecting Moral Boundaries
There Have Been Advances In Therapies That Use Stem Cells Drawn From Adults, Children, And The Blood From
Umbilical Cords - With No Harm To The Donor.
Researchers Are Now Developing Promising New Techniques That Offer The Potential To Produce Pluripotent
Stem Cells - Without Having To Destroy Human Life.
This month, several new studies showed the potential of reprogramming adult cells, such as skin cells, to make
them function like embryonic stem cells.
In January 2007, scientists discovered that cells extracted from amniotic fluid and placentas could also provide
stem cells that seem to do what embryonic stem cells can - without creating or destroying embryos.
The Administration Is Taking Immediate Action To Increase Our Support For These Researchers In Their Vital Work
Today, President Bush Issued An Executive Order To Strengthen Our Nation's Commitment To Research On
Pluripotent Stem Cells. The Order:
Directs the Department of Health and Human Services and the National Institutes of Health to ensure that any
human pluripotent stem cell lines produced in ways that do not create, destroy, or harm human embryos will be
eligible for Federal funding.
6/20/07
Expands the NIH's Embryonic Stem Cell registry to include all types of ethically produced human pluripotent stem
cells.
Renames the registry the Pluripotent Stem Cell Registry - SO that it reflects what the stem cells can do, instead of
where they come from.
Invites scientists to work with the NIH, SO we can add new ethically derived stem cell lines to the list of those eligible
for Federal funding.
President Bush Calls On Congress To Pass Legislation That Would Authorize Additional Funds For Ethical Stem
Cell Research So He Can Sign It Into Law. The Senate recently passed a bill that would authorize additional Federal
funding for alternative stem cell research, and the President calls on the House to pass similar legislation.
6/20/07
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Oregon scientist reports first ES cells from cloned primate embryos
By Natalie DeWitt and Monya Baker
The Niche-blog hosted by Nature Reports Stem Cells
http://blogs.nature.com/reports/theniche/2007/06/oregon_scientist_reports_first.html
Monkey embryonic stem cells have, for the first time, been created through somatic cell
nuclear transfer (SCNT). All attempts to make human embryonic stem cells through
nuclear transfer so far have failed, but Jamie Thomson got the recipe for human
embryonic stem cells by first doing so in monkeys, so researchers will likely be going to
Shoukhrat Mitalipov of Oregon National Primate Research Center for advice. Mitalipov
made his announcement Monday at the International Society for Stem Cell Research in
Cairns, Australia, in a special add-on presentation This finding represents a proof of
principle that therapeutic cloning to create patient-specific ES cell lines could work in
primates.
Mitalipov and his colleagues used a classic nuclear transfer procedure, where a somatic
cell nucleus (in this case form a skin biopsy from a ten year old adult rhesus monkey),
was inserted into an enucleated egg. The egg was prodded to start dividing, and
developed into a blastocyst (a hollow ball consisting of a few hundred cells). Then
Mitalipov teased out the cells of the inner cell mass, a thickening in the ball that would
have eventually formed the embryo proper if left undisturbed. Once they placed the cells
into a culture dish, the cells began to divide, forming the world's first cloned primate ES
cells.
The Oregon scientists isolated two separate monkey ES cell lines from 20 blastocysts,
and went on to show that the ES cells showed the genetic hallmarks of a true cloned cell
line, containing the mitochondrial DNA of the egg and the nuclear DNA of the somatic
donor cell (which in this case was a male, making it easier to rule out the possibility that
it was a parthenote.) The cells behaved like ES cells are supposed to do-- self renewing,
differentiating into cardiac and neuronal lineages in vitro, and forming teratomas after
injection into mice testes.
Mitalipov attributes his success to avoiding the use of a DNA stain to visualize the
nucleus of the oocyte during its removal. Instead he combined microscopy with a
visualization software that allowed him to see and remove the nucleus. The presumption
is that this technique leaves some reprogramming factors in the egg undamaged, allowing
them to transform the nucleus of a specialized cell.
"This is the first time this has been done in primates. It's something we've been looking
for," said Alan Trounson of Monash University, adding that the data have not yet been
published and the work not replicated and advising due caution.
Posted by Natalie DeWitt on June 18, 2007
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SS/ RM NO.
WHITE HOUSE STAFFING MEMORANDUM
Date: 6/18/07 7:00 P.M. ACTION / CONCURRENCE / COMMENT DUE BY: 6/19/07 10:00 A.M.
Subject: CLOSE HOLD - REMARKS ON STEM CELL VETO AND EXECUTIVE ORDER
ACTION FYI
ACTION FYI
VICE PRESIDENT
ROVE
BOLTEN
SNOW
BARTLETT
SULLIVAN,
CONNAUGHTON
TOWNSEND
FIELDING
WOLFF
HADLEY
WRIGHT
HAGIN
YANES
HUBBARD
ZINSMEISTER
KAPLAN
CLERK
LAZEAR
MARBURGER
MCBRIDE
MCGURN
PORTMAN
REMARKS:
PLEASE FORWARD COMMENTS DIRECTLY TO MELISSA CARSON, EXT. 6-2180 / FAX 6-2983, BY
TUESDAY, JUNE 19, 2007, AT 10:00 A.M., WITH A COPY TO THE STAFF SECRETARY. THANK
YOU.
RESPONSE:
KZ
CP
Assistant to the President
and Staff Secretary
Ext. 62702
FAX Ext. 62215
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FOIA IDs and Segments:
14303
2017-0029-F
OA Num.:
14165
2014-0503-F
NARA Num.:
14062
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 PRA]
b(7) Release would disclose information compiled for law enforcement
purposes [(b)(7) of the FOIA]
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(8) Release would disclose information concerning the regulation of
2201(3).
financial institutions [(b)(8) of the FOIA]
b(9) Release would disclose geological or geophysical information
Deed of Gift Restrictions
concerning wells [(b)(9) of the FOIA]
A. Closed by Executive Order 13526 governing access to national
Records Not Subject to FOIA
security information.
B. Closed by statute or by the agency which originated the document.
Court Sealed - The document is withheld under a court seal and is not subject to
C. Closed in accordance with restrictions contained in donor's deed
the Freedom of Information Act.
of gift.
This Document was withdrawn on 5/30/2019 by erg
Withdrawal Marker
The George W. Bush Library
FORM
SUBJECT/TITLE
PAGES
DATE
RESTRICTION(S)
Draft
[Draft]
2
N.D.
P5;
This marker identifies the original location of the withdrawn item listed above.
For a complete list of items withdrawn from this folder, see the
Withdrawal/Redaction Sheet at the front of the folder.
COLLECTION:
Domestic Policy Council
SERIES:
Zinsmeister, W. Karl - Subject Files
FOLDER TITLE:
Stem Cells 2007: Stem Cell Veto 2007 and Executive Order [1]
FRC ID:
FOIA IDs and Segments:
14303
2017-0029-F
OA Num.:
14165
2014-0503-F
NARA Num.:
14062
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 PRA]
b(7) Release would disclose information compiled for law enforcement
purposes [(b)(7) of the FOIA]
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(8) Release would disclose information concerning the regulation of
2201(3).
financial institutions [(b)(8) of the FOIA]
b(9) Release would disclose geological or geophysical information
Deed of Gift Restrictions
concerning wells [(b)(9) of the FOIA]
A. Closed by Executive Order 13526 governing access to national
Records Not Subject to FOIA
security information.
B. Closed by statute or by the agency which originated the document.
Court Sealed - The document is withheld under a court seal and is not subject to
C. Closed in accordance with restrictions contained in donor's deed
the Freedom of Information Act.
of gift.
This Document was withdrawn on 5/30/2019 by erg
Withdrawal Marker
The George W. Bush Library
FORM
SUBJECT/TITLE
PAGES
DATE
RESTRICTION(S)
Email
[Email] - To: Raul Yanes, et al. - From: Karl Zinsmeister
1
06/19/2007
P5;
This marker identifies the original location of the withdrawn item listed above.
For a complete list of items withdrawn from this folder, see the
Withdrawal/Redaction Sheet at the front of the folder.
COLLECTION:
Domestic Policy Council
SERIES:
Zinsmeister, W. Karl - Subject Files
FOLDER TITLE:
Stem Cells 2007: Stem Cell Veto 2007 and Executive Order [1]
FRC ID:
FOIA IDs and Segments:
14303
OA Num.:
2017-0029-F
14165
2014-0503-F
NARA Num.:
14062
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 PRA]
b(7) Release would disclose information compiled for law enforcement
purposes [(b)(7) of the FOIA]
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(8) Release would disclose information concerning the regulation of
2201(3).
financial institutions [(b)(8) of the FOIA]
b(9) Release would disclose geological or geophysical information
Deed of Gift Restrictions
concerning wells [(b)(9) of the FOIA]
A. Closed by Executive Order 13526 governing access to national
Records Not Subject to FOIA
security information.
B. Closed by statute or by the agency which originated the document.
Court Sealed - The document is withheld under a court seal and is not subject to
C. Closed in accordance with restrictions contained in donor's deed
the Freedom of Information Act.
of gift.
This Document was withdrawn on 5/30/2019 by erg
Withdrawal Marker
The George W. Bush Library
FORM
SUBJECT/TITLE
PAGES
DATE
RESTRICTION(S)
Email
Stem Cell Speech - To: William McGurn, et al. - From: Karl Zinsmeister
1
06/08/2007
P5;
This marker identifies the original location of the withdrawn item listed above.
For a complete list of items withdrawn from this folder, see the
Withdrawal/Redaction Sheet at the front of the folder.
COLLECTION:
Domestic Policy Council
SERIES:
Zinsmeister, W. Karl - Subject Files
FOLDER TITLE:
Stem Cells 2007: Stem Cell Veto 2007 and Executive Order [1]
FRC ID:
FOIA IDs and Segments:
14303
2017-0029-F
OA Num.:
14165
2014-0503-F
NARA Num.:
14062
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 PRA]
b(7) Release would disclose information compiled for law enforcement
purposes [(b)(7) of the FOIA]
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(8) Release would disclose information concerning the regulation of
2201(3).
financial institutions [(b)(8) of the FOIA]
b(9) Release would disclose geological or geophysical information
Deed of Gift Restrictions
concerning wells [(b)(9) of the FOIA]
A. Closed by Executive Order 13526 governing access to national
Records Not Subject to FOIA
security information.
B. Closed by statute or by the agency which originated the document.
Court Sealed - The document is withheld under a court seal and is not subject to
C. Closed in accordance with restrictions contained in donor's deed
the Freedom of Information Act.
of gift.
This Document was withdrawn on 5/30/2019 by erg
Withdrawal Marker
The George W. Bush Library
FORM
SUBJECT/TITLE
PAGES
DATE
RESTRICTION(S)
Email
FW: - To: Christopher Papagianis, et al. - From: Karl Zinsmeister
1
06/15/2007
P5;
This marker identifies the original location of the withdrawn item listed above.
For a complete list of items withdrawn from this folder, see the
Withdrawal/Redaction Sheet at the front of the folder.
COLLECTION:
Domestic Policy Council
SERIES:
Zinsmeister, W. Karl - Subject Files
FOLDER TITLE:
Stem Cells 2007: Stem Cell Veto 2007 and Executive Order [1]
FRC ID:
FOIA IDs and Segments:
14303
2017-0029-F
OA Num.:
14165
2014-0503-F
NARA Num.:
14062
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 PRA]
b(7) Release would disclose information compiled for law enforcement
purposes [(b)(7) of the FOIA]
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(8) Release would disclose information concerning the regulation of
2201(3).
financial institutions [(b)(8) of the FOIA]
b(9) Release would disclose geological or geophysical information
Deed of Gift Restrictions
concerning wells [(b)(9) of the FOIA]
A. Closed by Executive Order 13526 governing access to national
Records Not Subject to FOIA
security information.
B. Closed by statute or by the agency which originated the document.
Court Sealed - The document is withheld under a court seal and is not subject to
C. Closed in accordance with restrictions contained in donor's deed
the Freedom of Information Act.
of gift.
This Document was withdrawn on 5/30/2019 by erg