NIH Publishes Stem Cell Funding Guidelines

By Julie Rovner
WASHINGTON, DC, Aug 24 (Reuters Health) - US researchers could receive
federal funding to study the potential uses of stem cells derived from
human embryos under final guidelines unveiled by the National Institutes
of Health on Wednesday.  The new guidelines, however, which will be
published in Friday's Federal Register, are certain to touch off another
round of debate in Congress when it returns from its summer recess in 2
weeks.

Advocates and opponents of federal funding for research using human
pluripotent stem cells have been battling for months over the moral
and ethical propriety of using embryonic stem cells, which researchers
believe hold promise for the treatment of conditions such as diabetes,
Parkinson's disease, Alzheimer's disease and spinal cord injuries.

The guidelines, the first version of which were published in 1999, attempt
to steer a middle course in the ethically loaded debate. Under the rules,
federal funds could not be used to actually remove stem cells from human
embryos.  Federal funding also could not be used to create embryos for the
purpose of using stem cells.  Funding is limited to cells derived from
embryos created, but no longer needed, for in vitro fertilization.
Donors could not be paid for providing embryos.  The guidelines also
require strict informed consent procedures, including informing donors
that donated embryos will not survive the process by which the stem cells
are removed, and that donors will not benefit from any potential commercial
developments using the stem cells.

Researchers hailed the guidelines as a needed boost for a promising area
of research.  The guidelines "will enable this critical research to advance
without offending the moral and ethical sensibilities of the American
people," said Dr. Paul Berg, a Nobel Laureate from Stanford University
and chairman of the Public Policy Committee of the American Society for
Cell Biology.

Dr. John Gearhart of Johns Hopkins University, one of the researchers who
first isolated human pluripotent stem cells, said that the guidelines would
speed up research that has shown promise in animal studies.  "This is
significant.  It's terrific," said Dr. Gearhart, who spoke to reporters
on a conference call with Dr. Berg.

But right-to-life groups continue to maintain that the guidelines are in
direct contravention with the 5-year-old Congressional ban on research
using human embryos.  "This is clearly a violation of current law," said
Douglas Johnson of the National Right to Life Committee.  Richard
Doerflinger of the National Conference of Catholic Bishops added that
"this is falsification of science in the name of politics."

NIH has maintained that the Congressional ban does not apply to stem cell
research "because such cells are not embryos," according to an NIH fact
sheet.

Both Johnson and Doerflinger said that by publishing the guidelines that
allow the use of embryonic stem cells, NIH has ignored research findings
showing that adult stem cells also show promise in treating disease and
disability.  "The argument that [using embryonic cells] is the only way
to reach a therapeutic result becomes less convincing every week," Johnson
said.

Doerflinger said, "We could greatly expand funding of these alternatives
that have no moral problem and enormous promise."

But Drs. Berg and Gearhart said that while they support more funding of
research on adult stem cells, research also needs to go forward
simultaneously on embryonic cells.  Research on adult cells "is still
in its infancy," Dr. Berg said.  "Whether they are as able as the
embryonic stem cells in terms of the range of differentiation is yet
to be determined...I think what scientists are saying is: We ought to
explore both."

Even before the NIH action, Congress was scheduled to resume its debate
over the stem cell issue.  Senate Majority Leader Trent Lott, R-Miss.,
had previously promised Sen. Arlen Specter, R-Pa., a vote on Specter's
bill to clarify that federal funding of embryonic stem cell research is
allowed.  In exchange for Lott's promise, Specter, who chairs the
appropriations subcommittee that funds NIH, agreed not to insert similar
language into the 2001 funding bill.  As approved by the House and Senate,
the spending bill continues the language banning embryo research, but
does not specifically address the stem cell issue.

Even if Congress does not act to block the new rules, Gearhart said that
it will likely take at least a year for the first grants to be approved,
and 3 to 5 years before the first human clinical trials will likely begin.

Copyright © 2000 Reuters Ltd.

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