The Federation of American Societies for Experimental Biology (FASEB)  appreciates the opportunity to
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The Federation of American Societies for Experimental Biology (FASEB) appreciates the opportunity to

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8401 CONNECTICUT AVENUE, SUITE 900 CHEVY CHASE, MARYLAND 20815-5817 TELEPHONE 301.941.0200 FAX 301.941.0259 www.endo-society.org NIH Stem Cell Guidelines, MSC 7997 9000 Rockville Pike Bethesda, Maryland, 20892-7997 Dear Dr. Kington: The Endocrine Society appreciates the opportunity to comment on the National Institutes of Health (NIH) draft guidelines on human embryonic stem cell (hESC) research. Founded in 1916, The Endocrine Society is the world’s oldest, largest and most active organization devoted to research on hormones and to the clinical practice of endocrinology. Today, The Endocrine Society’s membership consists of more than 14,000 scientists, physicians, educators, nurses and students in more than 100 countries. Society members represent all basic, applied and clinical interests in endocrinology. The Society supports expansion of the availability of hESC for research and therapeutic purposes as intended by Executive Order 13505. We encourage NIH to continue to fund research on adult stem cells and on induced pluripotent stem cells even as the availability of hESC is increased. We agree with the stringent but reasonable guidelines NIH has outlined to ensure that excess embryos from fertility treatments are obtained ethically for the derivation of hESC lines. The Society has concerns, however, about potential negative consequences that may arise if the eligibility guidelines are retroactively ...

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8401 C
ONNECTICUT
A
VENUE
, S
UITE
900

C
HEVY
C
HASE
, M
ARYLAND

20815-5817

T
ELEPHONE
301.941.0200

F
AX
301.941.0259

www.endo-society.org
NIH Stem Cell Guidelines, MSC 7997
9000 Rockville Pike
Bethesda, Maryland, 20892-7997
Dear Dr. Kington:
The Endocrine Society appreciates the opportunity to comment on the National Institutes
of Health (NIH) draft guidelines on human embryonic stem cell (hESC) research.
Founded in 1916, The Endocrine Society is the world’s oldest, largest and most active
organization devoted to research on hormones and to the clinical practice of
endocrinology.
Today, The Endocrine Society’s membership consists of more than
14,000 scientists, physicians, educators, nurses and students in more than 100 countries.
Society members represent all basic, applied and clinical interests in endocrinology.
The Society supports expansion of the availability of hESC for research and therapeutic
purposes as intended by Executive Order 13505.
We encourage NIH to continue to fund
research on adult stem cells and on induced pluripotent stem cells even as the availability
of hESC is increased.
We agree with the stringent but reasonable guidelines NIH has
outlined to ensure that excess embryos from fertility treatments are obtained ethically for
the derivation of hESC lines.
The Society has concerns, however, about potential negative consequences that may arise
if the eligibility guidelines are retroactively applied to currently available hESC lines.
Furthermore, we recommend that the scope of research allowed under federal funding be
broadened to include research on cells derived from somatic cell nuclear transfer
(SCNT).
Though we understand that it is currently not allowed by law, we feel that NIH
support for the generation of new hESC lines would greatly facilitate the needed
expansion of available lines.
Our concerns and recommendations are detailed below.
Retroactive application of the eligibility guidelines could impose unintended
limitations on currently available cell lines.
The Society supports the human subject
protection and informed consent criteria outlined in the draft guidelines. However, it is
concerned that retroactive application of these criteria to previously derived and well
characterized stem cell lines could limit scientists’ access to a valuable resource.
The
Society encourages NIH to consider the spirit of the executive order and take steps to
ensure that the implementation of any guidelines would not restrict the eligible sources of
stem cell lines for research.
The scope of allowable research should be broadened to include cells derived from
SCNT.
In response to comments received regarding the 2000 draft guidelines on stem
cell research, NIH stated that it would disallow research on cells derived from SCNT
because the agency felt that research on such cells “has not received adequate discussion
and consideration by the public.”
If NIH were to clearly and logically outline the
scientific basis for its support of this technology, it could establish the scientific tone for
public debate regarding this powerful therapeutic technology.
SCNT presents a unique
opportunity to study cells with disease-causing mutations and to develop patient-specific
therapies.
Furthermore, SCNT is the only means by which scientists can accurately
identify and study reprogramming factors in the oocyte cytoplasm.
Given the enormous
potential to understand basic biological processes and to create genetically defined hESC
lines with SCNT, The Endocrine Society feels that government funding for research on
these lines should be allowed.
The number of hESC lines should be expanded.
The Society would also like to take
this opportunity to state its view that federal funding should be allowed for the derivation
of new hESC lines.
We understand that NIH is currently barred from funding derivation
of hESC by the Dickey-Wicker amendment, but the Society feels it is important that NIH,
as the nation’s major scientific agency, act as a champion for scientific progress and state
its support for this potentially life-saving avenue of research.
We support a continued
ban on reproductive cloning, but this scientifically distinct process must be separated
from the derivation of hESC in legislation and public policy.
Not only is it critical that
scientists be allowed to generate useful and informative cell lines, but by funding their
derivation, the government would be able to exert more control over the ethical
considerations involved.
At this time, private funds are the only allowable source of
funding for the derivation of hESC, and the Society feels that the federal government is
better equipped to enforce the ethical generation of these cell lines.
Once again, we
understand the current legal limitations, but we emphasize the need for the scientific
community to ensure that the public debate is well informed.
The Endocrine Society looks forward to the expansion of hESC lines eligible for federal
funding.
We encourage NIH to support all avenues of stem cell research.
If you have
any questions, or if the Society can be of any assistance moving forward, please contact
Loretta Doan, Associate Director of Science Policy, at
ldoan@endo-society.org
.
Sincerely,
Robert M. Carey, MD MACP
President, The Endocrine Society