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in this week's Nature Magazine
NIH stem-cell guidelines face stormy ride

[WASHINGTON] The US National Institutes of Health (NIH) moved a step closer
to
funding stem-cell research last week. A working group met to refine draft
ethical
guidelines that scientists would have to obey to meet congressional criteria
for
the
protection of embryos.

The working group deliberated over issues of informed consent, and wrestled
with
obscure but politically important definitions of words such as
'pluripotent'.
But opponents
of the research who attended the meeting lambasted the NIH for proceeding on
a
path
that, they claim, contravenes the spirit and the letter of a law that bans
federally funded
embryo research.

Maggie Wynne, dispatched by the Pro Life Caucus of the House of
Representatives,
urged NIH director Harold Varmus to reverse his decision to fund the
research.

The existing law prohibits funding for research in which embryos are
"destroyed
[or]
discarded", and extracting stem cells from embryos requires their
destruction.
The
Department of Health and Human Services interpreted the law in January as
saying
that
federal funds may finance work on existing stem cells, but not their
derivation
from
embryos, which would have to be financed privately (see Nature 397, 185;
1999).
(Stem
cells can also be derived from aborted fetuses, which is permissible under
federal law.)

At the meeting, the opponents said that recent work may obviate the need to
extract stem
cells from embryos. This research showed that more specialized stem cells in
adult tissues,
from brain to bone marrow, can give rise to a variety of tissue types
including
nerve cells,
cartilage, bone and connective tissue.

Richard Doerflinger, of the National Conference of Catholic Bishops,
declared
that
extracting stem cells from embryos may become "irrelevant". He urged the NIH
to
invest
instead in research on adult-derived stem cells for cell and tissue
replacement.

Using adult stem cells to derive specialized cells and tissues for therapies
would also
answer the problem of tissue rejection inherent in use of embryonic stem
cells.
Provided
that the science develops appropriately, an adult could simply have his or
her
own stem
cells harvested and instructed to differentiate into a particular type of
tissue; for instance,
insulin-producing pancreas cells for a diabetic, or dopamine-producing
neurons
for a
patient with Parkinson's disease.

By contrast, Brigid Hogan, a cell biologist at Vanderbilt University in
Tennessee, and a
member of the NIH working group, estimated that about 20 immunologically
different
lines of embryonic stem cells would need to be established for therapies to
allow immune
compatibility with most of the population.

Shirley Tilghman, a molecular biologist at Princeton
University, New Jersey, and co-chair of the working group,
emphasized that its mandate was to produce guidelines and
not to pronounce on whether the government ought to fund
stem-cell research. But, given the opposition among
anti-abortion groups and their allies on Capitol Hill, the
guidelines seem destined to become a political as much as an
ethical document.

In the event of a showdown between stem-cell research
opponents and supporters in Congress, vacillating politicians
being wooed by the promise of the research could point to the
guidelines as an assurance that federally funded research
would be conducted ethically. But, no matter what the
guidelines say, opponents are unlikely to be satisfied by them.

At the heart of the proposed guidelines is the requirement that
stem cells be extracted only from embryos left over from
fertility treatments. Those doing the extraction -- either
companies or scientists working with private funds -- would
have to provide to federally funded scientists receiving the
cells documentation that the embryos were created for
infertility treatment and not for research.

They would also have to guarantee that the woman who donated them did not
experience,
according to the draft, "undue or even subtle pressure to donate". She must
also
be
informed that commercial products could be developed from the cells, and who
would
own the products or patents. And the draft forbids the use of stem cells for
reproductive
cloning and the creation of human-human or human-animal chimeras.

In a separate move, a document released at the NIH meeting made it appear
that
President
Bill Clinton's National Bioethics Advisory Commission will be more
permissive
when it
makes recommendations on stem-cell research in June. In a letter sent to
Varmus
by
Harold Shapiro, chair of the commission, Shapiro wrote that "we seem to be
coming to
general agreement" that federal funding should be permitted for both the
derivation and
research use of stem cells derived from embryos left over from fertility
treatments and
from aborted fetuses.

MEREDITH WADMAN