Full text of DOI:10.1093/embo-reports/kvd084

EMBO
reports
Research on human embryonic stem cells
NIH issues new guidelines a week after British recommendations
‘Legal sophistry.’ That is what Senator
Sam Brownback (Republican, KS) calls
the newly issued US guidelines governing
taxpayer-funded research with human
embryonic stem cells. To tell the truth,
Senator Brownback has a point. The
guidelines, issued on August 23, specify
that researchers with grants from the
National Institutes of Health may work
only with cells from surplus frozen
embryos that would otherwise have been
discarded by fertility clinics (http://www.
nih.gov/news/stemcell/stemcellguide-
lines.htm). Furthermore, the researchers
may not extract the cells themselves, but
must obtain them from privately funded
middlemen who collect the embryos and
distribute the cells. The announcement
came only a week after the British govern-
ment released a scientific report recom-
mending stem cell research and said it
would ask parliament for approval this fall.
nary citizens is unknown. Not unexpect-
edly, it did not work with the organized
opposition. Every right-to-life advocate—
from the National Right to Life Committee
to the Pope—roundly denounced the new
guidelines. One harsh critic compared
NIH’s decision to allow using surplus
embryos to the Nazis justifying experi-
ments with inmates of concentration
camps on the grounds that they would be
dead soon anyway.
Researchers and patient advocates,
however, are jubilant at the prospect that
publicly funded human embryonic stem
cell research can finally go on after Con-
gress in 1996 prohibited the NIH from
funding research in which a human
embryo is destroyed. NIH grantees have
some catching up to do; a few private
companies, notably Geron Corporation in
Menlo Park, CA, have been working with
embryonic cells for two years. John
Gearhart of Johns Hopkins University,
who was the first to isolate stem cells from
human foetuses in 1998, declared, ‘this is
terrific. This is what I believe makes our
country top of the heap in terms of scien-
tific research.’ Said President Bill Clinton,
‘I think we cannot walk away from the
potential to save lives and improve lives,
to help people literally get up and walk, to
do all kinds of things we could never have
imagined, as long as we meet rigorous,
ethical standards.’
worried that applications like forestalling
ageing could represent the start of the slip-
pery slope towards turning human
embryos into a commodity.
‘Indeed, biotech companies can make
more money by offering to use them for
the burgeoning market of “enhancement”
medicine’, argued Lori B. Andrews, direc-
tor of the Institute for Science, Law and
Technology at the Chicago-Kent College
of Law and expert on the legal and ethical
issues posed by artificial reproduction.
She points out that Geron is touting the
artificial skin it is developing as a treat-
ment not just for burn victims but also for
people with sun damage and other age-
related conditions.
The scientific report approved by
the British government would
open the door to cloning human
embryos for purposes of disease
therapy
The NIH guidelines attempt to
reconcile two irreconcilable
views
The final guidelines are only slightly
different from the draft proposed in Decem-
ber last year. NIH reports that it received
>50 000 comments on that draft. Accord-
ing to an analysis by the American Society
for Cell Biology (http://www.faseb.org/
ascb/newsroom/SCGuidelineover.html),
many of the comments were simple expres-
sions of opposition to human embryo
research in any form, rather than critiques.
The new draft tries to address many of the
critics’ points without abandoning the
medically and financially promising field of
stem cell research. ‘I think the attempt to
find a compromise is reasonable. Restrict-
ing procurement to unwanted embryos
makes sense, since it shows respect for the
creation of embryos but does not treat them
as persons with the same rights as children
and adults’, said Arthur Caplan, Director of
The NIH guidelines attempt the impos-
sible: to reconcile two irreconcilable
views, those of a significant minority of
Americans who believe that human life
begins at conception and those of the
majority, who think otherwise. Thus, the
rules are not notably rational. But for the
lawyers and ethicists who danced endless
hours on the head of a pin to devise them,
rationality was not a priority. In the end,
they settled for attempting to reassure
those who oppose the research that at
least their taxes will not be spent—
directly—on creating human embryos for
the purpose of destroying them.
After the first isolation of stem cells from
human embryos, Science magazine in
1999 declared this discovery the ‘Break-
through of the Year.’ Embryonic stem cells
have been touted as a cure for just about
everything that ails us. The possibilities
range from spinal cord injury to diabetes
to wound healing, and especially the ills
of an ageing population: Alzheimer’s,
Parkinson’s, heart disease, strokes, osteo-
porosis and, perhaps, even senescence
itself. Even those who have no moral
objection to research with embryos, are
Whether this contemporary exercise in
medieval scholasticism will comfort ordi-
© 2000 European Molecular Biology Organization
EMBO Reports vol. 1 | no. 4 | 2000 297

analysis
the Center for Bioethics at the University of
Pennsylvania.
NIH recognizes these political realities.
The agency’s timetable for handing out
grants for research on human embryonic
stem cells is nothing if not deliberate.
Potential stem cell grantees must run two
gauntlets before their proposals even
make it into the agency’s usual pipeline
for consideration. First, they will be vetted
by the Human Pluripotent Stem Cell
Review Group, a special NIH committee
of scientists and ethicists that will make
sure the research design observes the
guidelines. A second committee of scien-
tists will subsequently take a look at pro-
tocols and judge scientific merit. Only
after passing muster with both committees
will a proposal be considered for funding.
One NIH official has said that work
might be funded as soon as early next
year, but it seems far more likely that suc-
cessful proposals will not get money until
the next fiscal year, at the end of 2001. As
further evidence that NIH is keeping its
usual prudent eye on the results of the
November 7 election, it has set the grant
proposal deadline for November 15, and
scheduled the first meeting of the Pluri-
potent Group for December.
Opponents have a powerful
argument against embryonic
stem cells: successes with stem
cells taken from adults
But how long that restriction can last is
uncertain. Eventually researchers will want
to create embryos from their patients’ tis-
sue, because cells transplanted from these
embryos will not risk rejection by the
patients’ immune system. The scientific
report approved by the British government
already goes in this direction. It not only
would allow extraction of stem cells from
embryos but also opens the door to clon-
ing human embryos via nuclear transfer—
but for purposes of disease therapy only,
rather than for reproduction.
Calls for the creation of human embryos
to use in research would certainly raise
hackles, even among those who are well-
disposed to using surplus embryos. In addi-
tion, the opponents now have an increas-
ingly powerful argument against it: a
recent string of successes with stem cells
taken from adults. Stem cell transplants
from mouse pancreas, for example, have
reportedly reversed diabetes in mice. Bone
marrow transplants have mitigated the
condition of people suffering from lupus
and may lead to therapies for other
immune system diseases. In fact, although
there was some excitement about stem cell
research in US financial markets after the
guidelines were announced, most of it
focused on companies planning to work
with adult cells.
Whether US taxpayers will bestow stem
cell research money on anybody, how-
ever, probably depends entirely on the
results of the upcoming national elec-
tions. The guidelines govern current pol-
icy, but they can be overturned in a trice
by congressional action or a presidential
executive order. Congress is polarized on
the issue, and so are the presidential can-
didates. Republican George W. Bush has
declared himself opposed to federal fund-
ing for stem cell research that involves
destroying a living human embryo. Dem-
ocrat Al Gore, the sitting vice president,
supports stem cell research, and so does
the party’s official platform. The present
Republican-led Congress is following a
firm policy of doing as little as possible
between now and Election Day, although
it will probably try to interfere with fund-
ing if the House remains under Republi-
can control. But since all 435 members of
the House of Representatives are up for
re-election, and so is one-third of the
Senate, majority sentiment might well be
completely different after the election in
November.
Tabitha M. Powledge
The author is a freelance science writer and editor
near Washington, DC.
E-mail: tam@nasw.org
DOI: 10.1093/embo-reports/kvd084
Toxins for terrorists
Do scientists act illegally when sending out potentially dangerous material?
I
n 1999, Tommy Nilsson, Rainer Pepper-
league who asks for it. But one aspect of
the request for the toxin constructs made
him hesitate. The letter came from North
Korea. After considering the request and
discussing the matter with other col-
leagues, Nilsson decided not to send these
plasmids to a country labelled as a ‘rogue’
state. ‘You have to think about what conse-
quences might arise from this,’ he
explained, ‘because the material might fall
into the hands of people working on bio-
logical weapons.’ Indeed, he did not make
his decision easily. ‘I felt pretty bad about
not sending it,’ he said, ‘because you are
obliged to send out material after you have
published it—–that’s the norm. And you
must pay particular attention to requests
from third world countries where any
material, be it an antibody or a plasmid,
may be of great help.’
kok and Brian Storrie published results
about protein export in cells they obtained
by using shiga toxin. One month later,
Nilsson (a group leader at the European
Molecular Biology Laboratory in Heidel-
berg, Germany) received a request for the
plasmids that his laboratory used to pro-
duce non-toxic fragments of the toxin. As a
scientist, Nilsson shares his published
knowledge and material with every col-
Nilsson made his decision because he
was uncertain about legal aspects and the
298 EMBO Reports vol. 1 | no. 4 | 2000
© 2000 European Molecular Biology Organization