09-01-2001

SCIENCE: Next Battle in the Stem-Cell War

In the wake of President Bush's decision to provide federal support for
research on some stem cells taken from human embryos, the debate is
shifting to funding priorities and to related arguments over human
cloning.


One of the central players is Tommy G. Thompson, Health and Human Services
Secretary, whose department oversees the National Institutes of Health. In
the months leading up to Bush's decision, Thompson pushed hard for federal
funding of embryonic stem-cell research; in the days since Bush's
decision, Thompson has sketched out plans to use federal dollars for
research into the controversial cells. "Because embryonic stem cells
are so important and [have] got to have some opportunity to catch up to
what's going on in adult stem cells ... upwards to $100 million, more than
likely, will be apportioned to the embryonic stem-cell portion of
research," Thompson said in an August 12 interview on CNN. In other
statements, Thompson has said he would fund studies comparing embryonic
stem cells with those taken from adults, umbilical cords, and placentas,
"so we can answer the question, Which ones are the best?" That
comparison, he said, "is what the President wants."


The biotech industry welcomed Thompson's statements on funding. His stance
"goes beyond the amber light" that Bush gave for embryo
research, said Carl B. Feldbaum, president of the Biotechnology Industry
Organization. "That turns it into a green light." Throughout the
debate on stem cells, Feldbaum said, Thompson has been "very much in
our corner."


Critics of embryonic stem-cell research, who object to it because the
embryo is destroyed to get the cells, say that Thompson's funding
projection of $100 million for the work could actually exceed funding for
the noncontroversial work on other types of stem cells. Richard M.
Doerflinger, associate director of anti-abortion policy at the U.S.
Conference of Catholic Bishops, said Thompson's belief that embryonic work
needs "to `catch up,' sounds as though he is treating this as a race,
and he wants to make sure the embryo cells have at least an equal chance
of winning." He added: "The adult cell work should be fully
explored first to see if one does not even need to broach the moral
problem of embryo work."


Doerflinger, Republican staffers on the Hill, and other opponents of
research on embryonic cells say they fear that NIH will fund embryo
research at the expense of research into stem cells taken from adults,
umbilical cords, and placentas. "The heads of [NIH's 27 centers and]
institutes have given only lip service to the adult stem cells,"
Doerflinger said.


Campbell Gardett, an HHS spokesman, said that opponents of embryo research
"are reading too much into" Thompson's "catch-up"
statement. "The fact is that NIH has not been able to invest any in
the embryo [research], so ... its funding needs to catch up." A
senior White House official who asked to remain anonymous also defended
the Administration's funding plans in an interview with National Journal.
"The President made clear he is interested in aggressively funding
all areas of stem-cell research ... within the ethical boundaries set by
the President," the official said. "The NIH leadership has made
it very clear in recent discussions ... that they intend to promote the
President's policy" of funding research on adult as well as on
embryonic stem cells.


But as the research moves ahead, it may be difficult to track and compare
NIH spending on embryo projects with that spent on adult research
projects. Thompson's $100 million funding projection for work on cells
from donated embryos is less than the $256 million that NIH officials say
they will spend this year on all other forms of stem cell work, but
experts say that these two pots of money can't be clearly
distinguished.


They point out that the $100 million cited by Thompson is for basic,
"cutting-edge" research designed to produce significant
scientific advances, while the $256 million is more diffuse. For example,
the $256 million includes $79 million for work on adult animal stem-cell
research, and $30 million for embryonic animal stem cells. That leaves
$147 million for work on human adult stem cells. But a large part of the
$147 million is being spent on expensive clinical trials of patient
therapies that use adult stem cells, further reducing the money available
for basic scientific research on adult cells. NIH's clinicaltrials.gov Web
site lists 192 clinical trials involving adult stem cells, many of which
are funded by NIH. These NIH grants average $1 million; grants for basic
research average only $250,000.


Conservative critics point out that the $100 million that Thompson
suggested be dedicated to embryonic cell research is only for stem cells
taken out of embryos received from fertility clinics. But research on stem
cells taken from aborted embryos may be paid for out of funds from the
$256 million allocated to adult cell work, critics said. "We think it
is part of the $256 [million]," said HHS spokesman Bill Pierce. He
added that Thompson's $100 million estimate "is a floor of what he
would expect."


In addition, overall funding for basic embryonic cell research may be
boosted further by requests from researchers to reassign their NIH grants,
originally awarded for other types of medical research, to embryonic cell
research. NIH officials have invited researchers to make such
requests.


Faced with these funding uncertainties, Rep. Christopher H. Smith, R-N.J.,
has drafted a bill that would direct NIH to spend an extra $30 million on
adult stem-cell research. A similar bill in the Senate, introduced by John
Ensign, R-Nev., would authorize $1.1 billion for such research between
2003 and 2006.


Doerflinger and other like-minded critics say that adult stem cells are
providing the needed therapies for patients and are already being used.
Moreover, Bush might be able to avoid ongoing controversies over stem
cells if NIH support of adult stem-cell research yields additional
therapies, Doerflinger said. Already, Massachusetts-based Advanced Cell
Technology Inc. has applied for patents in the United States and the
United Kingdom on a technique to create embryo-like stem cells without
creating or destroying an embryo. Other companies, such as PPL
Therapeutics in Blacksburg, Va., are developing comparable
technologies.


On the other side of the debate, some supporters of embryonic cell
research are concerned that NIH may not help them get easy and cheap
access to patented stem-cell technology. The Wisconsin Alumni Research
Foundation, based in Thompson's home state, holds the patents to key
stem-cell technology. It has already given Geron Corp. the right to
commercially market six types of cells, including blood and brain cells,
that might be produced by manipulating embryonic cells. At least one
university has backed out of licensing talks with Geron, complaining that
the company wanted too high a price for access to its stem cells. WARF and
Geron are now arguing in court over whether their contract gives Geron an
exclusive commercial right to an additional six types of cells.


Bush's decision on stem cells has added new intensity to the debate over
human cloning, which the House banned by a vote of 265-162 on July 31.
Sen. Sam Brownback, R-Kan., has announced plans to force a vote on a
similar bill in the Senate. Sen. Bill Frist, R-Tenn., has sketched out a
plan under which the federal government would support research on
embryonic cells but would ban all forms of cloning.


Generally, researchers in academia and industry support a narrow ban on
the birth of a human cloned at the embryo stage. However, they usually
oppose laws that would ban the cloning of human embryos for use in
large-scale laboratory experiments or to serve as stem-cell donors. In the
House vote, most Democrats voted for an industry-backed alternative bill
that would have curbed the birth of cloned humans but licensed the
creation of cloned human embryos for research.


Much depends on Senate Majority Leader Thomas A. Daschle. In various
statements in July, Daschle said he opposed the birth of human clones. On
August 1, he said, "I'm very uncomfortable with even cloning for
research purposes, but I am strongly in support of the effort to try to
advance science and research through the use of the embryo."
Daschle's spokeswoman, Anita Dunn, said the Democratic Senator did not
expect to bring up Brownback's anti-cloning bill for debate. Brownback,
however, could attach it to a variety of other bills, including a proposed
measure to expand federal support for embryonic stem-cell research. That
measure has been drafted by Sens. Tom Harkin, D-Iowa, and Arlen Specter,
R-Pa. Attaching the anti-cloning measure to the Harkin-Specter bill might
give some swing-vote Senators the opportunity to simultaneously vote for
two measures that get strong support from different constituents.


Doerflinger said he would oppose such a combined bill, partly because a
promised presidential veto of the Harkin-Specter measure would kill the
cloning-ban rider. The combined bill is also opposed by Daniel Perry,
executive director of the biotech-industry-backed Alliance for Aging
Research in Washington. Perry is also a founding member of the Patients'
Coalition for Urgent Research, which lobbied for federal support of
research on embryonic cells. Even though Bush's stem-cell plan may not be
broad enough, said Perry, such a combined bill "would be a bad
bargain" because of the cloning ban.


If Brownback's anti-cloning bill comes up for a vote, the fact that the
President has already made the stem-cell decision will make it easier for
the Senate to reject it, Perry said. "Because the stem-cell cloud has
passed over, people will be able to look at the issue of cellular nuclear
transfer [cloning, and its benefits,] straight on," he said.


Both sides believe they can win the cloning fight in the Senate. "I
think we can," said Kenneth Connor, president of the Family Research
Council, who favors a ban on all human embryo cloning, partly because of
support from left-of-center groups that oppose human cloning by biotech
companies. "I believe we can win," said Feldbaum, who supports
only a ban on the birth of human clones. But "I'm not
complacent."


Neil Munro

National Journal