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

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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

[e-mail]

.

Sincerely,

Robert M. Carey, MD MACP

President, The Endocrine Society