For those outside the beltway, the following article appears on page A8 of
Sunday's Washington Post.

Tony Mazzaschi
AAMC

Future of Stem Cell Tests May Hang on Defining Embryo Harm

By Rick Weiss
Washington Post Staff Writer
Sunday, July 29, 2007; A08

With the active encouragement of the Bush administration, U.S. scientists in
the past year have developed several methods for creating embryonic stem
cells without having to destroy human embryos.
But some who now wish to test their alternatively derived cells have found
themselves stymied by an unexpected barrier: President Bush's stem cell
policy.
The 2001 policy says that federal funds may not be used to study embryonic
stem cells created after Aug. 9 of that year. It is based on the assumption
that the only way to make the cells is by destroying human embryos -- a
truism in 2001 but not any longer.
As a result, the National Institutes of Health recently refused to consider
a grant application for what would have been the first federal study to
compare several of the new, less politically contentious stem cell lines.
"This is not the way to make good health policy," said Robert Lanza, the
frustrated vice president for research and scientific development at
Advanced Cell Technology (ACT) in Worcester, Mass. Lanza submitted the study
proposal with stem cell experts from several major research labs.
Upcoming changes in the NIH's stem cell funding rules may eventually help
resolve that problem. But agency officials and others say the policy tangle
is more complicated than that. Although Lanza's technique and other new
approaches do not destroy embryos, they may run afoul of a long-standing
congressional ban on studies that "harm" human embryos.
That vague language raises the perplexing question of how one would know
whether an embryo had been harmed.
At the center of the debate is a new technique, pioneered by ACT, that
obtains stem cells from human embryos while leaving the embryos functionally
intact. A single cell, called a blastomere, is removed from an eight-cell
human embryo, then coaxed to multiply into a colony of stem cells in a dish.
Fertility doctors have been performing these blastomere biopsies for years
to identify embryos that harbor genetic defects. Since a single cell is
representative of the entire embryo, doctors transfer to a mother-to-be's
womb only those embryos whose plucked cells pass genetic muster. The loss of
a single cell -- or even two -- at that stage is not known to cause
developmental problems in children born by this procedure, doctors say.
In unpublished research, ACT has made several colonies of stem cells this
way, Lanza said. The seven-cell embryos developed normally and were frozen
after the procedure a couple of days later, as embryos typically are until
used by infertile couples.
The question is whether stem cells made this way are as versatile as those
harvested from destroyed embryos. And what about stem cells created by other
means, such as those of Anthony Atala, the Wake Forest University scientist
who in January announced he had isolated embryonic stem cell equivalents
from amniotic fluid?
To find out, Lanza joined with Atala and a team of others to compare stem
cells made by various means. The group submitted a proposal to the NIH in
February, then waited. And waited.
Eventually, the NIH told the team that it had referred the proposal to a
different review group. Then, in a series of e-mails, the agency backed off
further, first encouraging the applicants to drop Lanza's cells from the
proposal and, finally, when the team refused to do so, informing them that
the application was being sidelined indefinitely for "administrative
review."
Story Landis, who heads the NIH's stem cell task force, said the main issue
is Bush's Aug. 9, 2001, stem cell policy. It called upon the NIH to make a
list of all embryonic stem cell lines known as of that date and blocked
funding for research on any cells but those on the list.
"Currently, there are no cell lines derived from single blastomeres listed
on the stem cell registry as eligible for funding," Landis said.
Sean Tipton, president of the Coalition for the Advancement of Medical
Research, a stem cell research advocacy group, said the policy amounts to a
Catch-22.
"On the one hand, they're saying, 'Find this out,' " Tipton said, referring
to the Bush administration's repeated call for scientists to find ways to
make and study stem cells without destroying embryos. "On the other hand,
they're saying, 'You're not allowed to do the research to answer these
questions.' "
A little-noted executive order issued by Bush last month, when he vetoed
legislation that would have expanded embryonic stem cell funding, could
eventually help resolve the problem, Landis said.
It instructs the NIH to rewrite the rules for funding stem cell research,
with the emphasis not on whether the cells came from embryos but on whether
any embryos were harmed.
Bush, in an interview this week with The Washington Post, reiterated his
belief that "there are ways to develop stem cell lines without the
destruction of human life. There's a myriad of ways to advance good science
without crossing an ethical line."
It is unclear whether ACT's blastomere-derived lines, or those obtained from
embryos by other means, might be deemed eligible. A 2005 report by President
Bush's Council on Bioethics concluded that the blastomere approach (still
theoretical at that time) "might be eligible for funding" under the
do-no-harm-to-an-embryo standard. But the report raises a concern.
"[E]ven if development proceeds in a healthy manner, it may be that the
child born is somehow a different child than the one that would have
resulted from an undisturbed embryo," the report said, without opining on
whether such a shift of fate would constitute harm.
The legal standard of allowable harm to an embryo is spelled out in 1995
congressional language and is reiterated in Bush's June 2007 executive
order. It bans federal funding of research that subjects an embryo to more
than "minimal" risk, although greater risk is allowed if the research is
anticipated to benefit the embryo.
For now, Lanza has suggested limiting his technique to embryos that are
already due to be biopsied at a fertility clinic. The plucked cell could
divide for a day, providing enough cells for both the genetic testing and to
start a line of stem cells. That way the embryo would not be subjected to
any new or additional risk.
Still, for funding, that risk would have to be "minimal" -- a standard open
to "interpretative discretion," said R. Alta Charo, a professor of law and
bioethics at the University of Wisconsin at Madison.
From one perspective, she said, fertility clinic testing can be seen as a
risk because if the embryo "fails" its genetic test, it will not be given an
opportunity to grow into a child.
But some couples who know they harbor genes that can cause a fatal childhood
disease might never risk having children unless they could test their
embryos and select those not affected. For those embryos, the test poses an
opportunity for life that would not otherwise exist.
Charo said that she is uncomfortable with both ideas, because they "suggest
the embryo has an active interest in being born" -- a philosophical notion
that imputes a level of personhood to embryos that many stem cell supporters
do not accept.
Landis, of the NIH, would not say how the agency will decide which cell
lines involve risks small enough to be eligible for funding, nor would she
say what role, if any, the White House will have in those decisions.
Agency insiders, however, said the NIH is likely to convene workshops and
fund animal tests to study the degree of harm various procedures pose to
embryos -- a meticulous approach that strengthens suspicions among research
proponents that real stem cell policy changes are unlikely while Bush is in
office.
"I think they're trying to ride the clock out," Lanza said.
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