BIOMEDICAL POLICY:
Bush
Squeezes Between the Lines on Stem CellsGretchen
Vogel*
President Bush's decision to support the use of existing
embryonic stem cell lines surprised many and angered some. It also
triggered a hunt to find themEnding months of
speculation, President George W. Bush told a national TV audience on
9 August that he would allow the federal government to fund work on
embryonic stem (ES) cells. But rather than settling the debate,
Bush's compromise has sparked a new round of scientific questions,
including exactly how much research the new policy will permit.
Although the president's decision may temporarily halt a political
push for more research opportunities, his assertion that some 60 ES
cell lines would be available for research is more than twice the
number most scientists would cite.
In his first televised speech since January, Bush announced that
the National Institutes of Health (NIH) can fund work with human ES
cells--but only those cell lines derived before his announcement.
The spin has been generally favorable: Both supporters and opponents
of the research, who had condemned such a compromise last month
(Science, 13 July, p. 186),
praised the decision. "The compromise he's tried to achieve is a
laudable one," says cell biologist Douglas Melton of Harvard
University, who works with both human and mouse ES cells. And
although some pro-life groups, including the U.S. Conference of
Catholic Bishops, condemned the decision, others said the president
had kept his campaign pledge to oppose research that destroys
embryos.
Embryonic stem cells can in theory develop into any cell type in
the body, and many scientists think they could eventually be used to
treat chronic diseases such as diabetes or Parkinson's. Any clinical
applications, however, are many years away. But because the cells
are derived from week-old human embryos, which are destroyed in the
process, their use has been controversial. Last summer, NIH issued
guidelines to govern work on the cells, but the new Administration
halted their implementation this spring while it reviewed the issue.
When the White House floated this compromise several weeks ago,
scientists in favor of ES cell work said that too few cell lines
would be available to fully determine the potential of this new
field. They were also concerned that many of the existing cell lines
have commercial strings attached that could limit research.
In response, Secretary of Health and Human Services Tommy
Thompson asked Lana Skirboll, head of science policy at NIH, to
tally the number of cell lines worldwide. To her surprise, Skirboll
said at a 10 August press conference, her staff tracked down at
least 60 from five countries: the United States, Australia, Sweden,
Israel, and India. All 60 lines are propagating, she said, have cell
surface markers characteristic of ES cells, and should be available
to researchers within months. The unexpectedly high number of cell
lines arose, Skirboll said, because many researchers have been
keeping quiet and agreed to talk to NIH only under conditions of
confidentiality.
Talking points. HHS
Secretary Tommy Thompson, flanked by NIH's Ruth Kirschstein and Lana
Skirboll, explains the president's decision.
CREDIT: MARTY KATZ
"If there are 60 cell lines, that's news to me--and good news,"
Melton says. He cautions, however, that the properties of the
purported cell lines are unclear, as are intellectual property
rights. Cell surface markers, for example, are a "necessary but not
sufficient" indication of an ES cell line's characteristics, he
says.
An informal search by Science turned up 34 distinct cell
lines in four countries. At least seven cell lines have been
described in peer-reviewed publications: five by James Thomson of
the University of Wisconsin (UW), Madison, and two by Martin Pera of
Monash University in Melbourne, Australia, and his colleagues.
(Scientists from the Jones Institute in Virginia published a
description of two ES cell lines, but they do not qualify for NIH
funding because they were derived from embryos specifically created
for research.)
The remaining new lines have been described at scientific
meetings or in conversations with Science. Pera's team has
derived four more lines, he says. Joseph Itskovitz-Eldor of Technion
University in Haifa, Israel, who collaborated with Thomson to derive
the first ES cell lines, told Science he has derived three
more of his own. Bresagen, a company based in Atlanta, announced
having derived four. Peter Eriksson told Science that he
and his colleagues at Göteborg University in Sweden have derived
five lines and have so far characterized three. Michael Andäng of
Huddinge University Hospital outside Stockholm told Science
that he and his colleagues are characterizing "five to 10 human ES
cell lines" they have derived. Roger Pedersen of the University of
California, San Francisco (UCSF), has derived at least one.
Science could not confirm reports of work with human ES
cells in India. Reliance Life Science of Bombay markets a product
called ReliCord, derived from umbilical cord blood. The company was
rumored to have ES cell lines, but Anand Rao, research director for
cell biology, told Science it has none. Manju Sharma,
India's biotechnology secretary, says she knows of no ES cell lines
in the country.
Pera echoed the general surprise at NIH's total, suggesting that
they may still be in early, uncertain stages of derivation. "It is
no small chore to derive, cryopreserve, and properly characterize
three or four lines," he says. "Someone must have a factory
somewhere, or we are talking about potential cell lines."
But at the briefing Skirboll stood by her number and predicted that
even more cell lines would come to light.
Relaxed
requirements
Even as the president sought to
limit criticism by opponents of ES cell research, the ethical
requirements that he laid down last week are much simpler than those
issued last summer by NIH. The new criteria require that cell lines
have been derived from embryos that were created for fertility
treatments but are no longer needed. In addition, the couples
donating the embryos must have given their informed consent, without
any financial inducements. By contrast, the NIH guidelines issued
last summer stipulated that NIH-approved cell lines must have been
derived from frozen embryos, and those doctors procuring the embryos
could not also derive the cell lines. In addition, the consent form
had to meet certain strict criteria, explicitly stating, for
example, that the cell lines "may be kept for many years"
(Science, 1 September 2000, p. 1442).
The NIH guidelines, which were never implemented, would have forced
researchers to derive new cell lines, while Skirboll says that all
60 lines meet Bush's looser ethical criteria.
SOURCE: LEROY WALTERS/GEORGETOWN
UNIVERSITY
The new policy may also ease some administrative burdens.
Skirboll said that NIH was reviewing a prohibition against
commingling any federal research funds--even support for building
maintenance and upkeep--with private money used for embryo research
that NIH is not allowed to fund. That policy has forced some
researchers, including UW's Thomson and Pedersen at UCSF, to set up
separate laboratory space for their human ES cell work.
Bush's announcement does not affect research in the private
sector. Companies or university researchers with non-NIH funding can
derive new cell lines, but the NIH will not fund work with such
lines. NIH is also scrapping its Human Pluripotent Stem Cell Review
Group (HPSCRG), which was to have met in April to determine whether
several newly derived cell lines would qualify. "There will be no
new derivations for the NIH to approve," says Skirboll, "so there is
no need for the HPSCRG."
Show me the cell lines.
Scientists in four countries report developing a total of
34 cell lines, far short of the 60 mentioned by President Bush.
NIH has already begun setting up a registry of qualifying cell
lines, said Skirboll, with cell lines that pass muster going into a
database. Scientists will have to specify which cell line or lines
they plan to use and make the necessary material transfer agreements
(MTAs) with companies that own the cells.
At the 10 August press conference, Thompson said that a scientist
has been chosen to lead the database compilation but declined to
disclose the name. He also said NIH could begin funding new grants
to work with ES cells by early next year, and scientists could apply
for supplemental grants even sooner--perhaps within weeks.
Which cell lines come with strings attached--and how tight those
strings are-- remains unclear, as much of the derivation research to
date has been funded by companies. "There are strong property and
patent issues to work through," Thompson acknowledged at the press
conference. Several scientists, for instance, chafed at the
requirements of an earlier MTA from WiCell, the not-for-profit
company UW set up to distribute the human and rhesus monkey ES cells
derived by UW researchers. Skirboll said that the owners of several
cell lines have promised to work with scientists.
The compromise seems to have slowed momentum in Congress for
passage of a bill, sponsored by Senators Arlen Specter (R-PA) and
Tom Harkin (D-IA), that would allow NIH also to fund work on the
derivation of new cell lines. Robert Rich, president of the
Federation of American Societies for Experimental Biology, which had
lobbied hard for the Specter-Harkin bill, predicted that advocacy
groups would ease up on their efforts, at least in the short term.
Says Rich: "Most of us will take a deep breath for now and will wait
for the 60-plus stem cell lines that the president says are
available for research to appear."
Even if the research community gains access to all 60 cell lines,
Philip Noguchi of the Food and Drug Administration says that it is
very unlikely that any of the existing cell lines would be approved
for clinical trials. That drives home one point in President Bush's
speech: Despite the promise of ES cells, real treatments are still
many years away.
With reporting by Constance Holden, and Pallava
Bagla in New Delhi.
Volume 293,
Number 5533, Issue of 17 Aug 2001, pp. 1242-1245.
Copyright © 2001 by The American Association for the
Advancement of Science.
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