The Politics of Stem Cells

Legislative uncertainties hinder research in the U.S.



By Bruce Agnew

February 21, 2003

Some of the most exciting biomedical research of the 21st-century
isn't getting done. Research on stem cells from human embryos has
become so entangled in politics and public misunderstanding that
researchers are worried about serious delays in understanding life-
threatening diseases.

Particularly in the United States, research involving human embryonic
stem cells has slowed because of philosophical qualms, political
opposition and confusion about the science. What's more, the field
now seems treacherous for scientists, largely due to legislative
uncertainties and restrictions on research from the White House.

"There are a lot of experiments that are obvious and would be
extremely valuable for scientists to do," says Keith Yamamoto, vice
dean for research at the University of California, San Francisco
School of Medicine. "But it's too much work to put together a
research proposal only to find out it's going to be made illegal—or
that there will be a four-year moratorium proposed."

President Bush declared in 2001 that scientists who receive federal
research funds— by far the majority—could work only with a handful of
stem cell lines (those that were in existence before August 9, 2001).
The White House said that more than 60 usable embryonic stem cell
lines were available. But in reality the number is closer to nine.

To compound the problem, Congress has threatened to make it illegal
to use cloning to create new stem cell lines for biomedical research.
The possibility that Congress will outlaw the use of cloning
technology to derive new cell lines is scaring researchers away,
according to Yamamoto and other scientists.

Prospects seem dim that the controversies—and the uncertainties—will
be resolved anytime soon. However, one "research friendly" bill has
been introduced in the Senate and has attracted support from an odd
but important coalition of influential people. One of them is Nancy
Reagan, whose husband, the former President, is in a late stage of
Alzheimer's disease.

Nancy Reagan
"I am determined to do what I can to save other families from this
pain," she said in a letter, arguing in favor of stem-cell research
with appropriate safeguards.

The opening days of the new Congress saw a virtual rerun of last
year's fights. Over just the past few weeks:

-President Bush in his State of the Union address urged Congress to
prohibit "all" human cloning "because no human life should be started
or ended as the object of an experiment."

-Legislation was introduced in both House and Senate to ban the use
of "somatic cell nuclear transfer"—the cloning technique by which
Dolly the sheep was produced—to create a living human organism "at
any stage of development." Within a few days of its introduction, the
House bill had attracted more than 100 co-sponsors.

-A competing bill that would prohibit human reproductive cloning but
would permit nuclear transfer to create embryonic stem cell lines for
research was introduced in the Senate.

This latter, pro-research measure is cosponsored by an ideologically
broad coalition, ranging from Diane Feinstein (D-CA) and Ted Kennedy
(D-MA) to Zell Miller (D- GA) and Orrin Hatch (R-UT), whose right-to-
life credentials are unassailable.

Essentially the same alignment of forces in the previous Congress
produced a stalemate. The House passed a broad anti-cloning bill by a
265-162 vote in July 2001, but neither the broad prohibition nor a
pro-research version came to a vote in the Senate because neither
side could muster the 60 votes needed to shut down a Senate
filibuster.

The most likely outcome now seems to be a continuing standoff unless
members of Congress can learn the difference between using stem cells
for research and using them for human reproduction.

Even if the Senate passed a pro-research bill, the House would be
unlikely to agree. And even if such a bill made it through Congress,
President Bush would likely veto it. The question of using somatic
cell nuclear transfer to derive human embryonic stem cells involves
an uncomfortable mix of science (including cell cloning), ethics and
theology. It has not yet resulted in any useful compromise.

To scientists, cloning means making a copy of something —anything, a
stretch of DNA, a virus, a cell. To most laypeople, including many
members of Congress, cloning means creating a carbon-copy organism,
like Dolly the sheep or the army of clones in a recent "Star Wars"
movie. It means making an exact copy of a living adult and the
imagination often focuses on evil ones at that.

"We have to do a better job of educating the public that the word
'clone' is not synonymous with movies such as 'The Boys from Brazil'
or 'The March of the Clones' or whatever else Hollywood has
manufactured," says Nobel Laureate Paul Berg of Stanford University
in California.

Opponents, such as President Bush and Leon Kass, chairman of the
President's Council on Bioethics, believe that any use of somatic
cell transfer could result in a human embryo, and thus a human life.
"We find it disquieting, even somewhat ignoble, to treat what are in
fact the seeds of the next generation as mere raw material for
satisfying the needs of our own," a majority of Kass's council
reported last July.

But proponents of this somatic cell technology deny that the
technique produces the seeds of any generation. "I'm in favor of
cloning nuclei in the form of stem calls," says Berg. "The product of
that is not a human being." Some scientists and ethicists go so far
as to argue that it is actually unethical not to do research that
shows unusual promise for treating or preventing devastating disease.

Senator Hatch, whose influence as a conservative leader makes him an
important player in the debate, argues that human life begins in the
womb, not in a petri dish.

"Even those who believe that life begins at conception, even if the
unison of sperm and egg takes place in the lab, need to consider
carefully whether the joinder of an enucleated egg with a somatic
cell nucleus, accompanied by chemical or electrical stimulation,
should fairly be thought of as the same process as conception," Hatch
told a Senate hearing in January.

Last July, Kass's bioethics council recommended a four-year
moratorium on all research with somatic cell transfer if the intent
is to produce human embryonic stem cells. Seven of the scientists on
the Kass council voted against a moratorium; all of the ethicists
voted in favor, as did one physician-scientist. Meanwhile, two
separate committees of the National Academy of Sciences endorsed the
research on grounds of its value to medicine.

Several states with ambitions to attract the biotechnology industry,
including California and New Jersey, have tried to pass legislation
of their own that would prohibit the use of cloning to make babies
but would allow somatic cell nuclear transfer for scientific
research.

In addition, some major research institutions, including Stanford and
UCSF, have established satellite research centers that receive no
federal funds to pursue such research. An outright federal
prohibition would override these efforts.

A federal prohibition of all research to use this technology to
create human embryonic stem cells also could erode one of the major
potential benefits of stem cell science: the growth of replacement
tissue such as cardiac muscle to repair heart damage, insulin-
producing beta cells to cure type 1 diabetes, or dopamine-producing
neurons to treat Parkinson's disease.

Theoretically, if a patient is his or her own donor of the somatic
cell from which the embryonic stem cells would be grown, implanting
the replacement tissue would raise no immunologic problems. This,
clearly, has nothing to do with human reproduction.

The congressional standoff leaves would-be stem cell researchers with
limited options. They can try to develop procedures with private
industry or state funding— although that may eventually be
prohibited. Or they can work with human embryonic stem cell lines
derived from embryos originally created for in vitro fertilization
(IVF) procedures.

This is where the president's moratorium of 2001 becomes an issue. A
repertoire of nine cell lines with which to work is far different
than 60 available cell lines. And because data suggest that none of
those lines may be the best for use in medical experimentation, the
need to develop new lines is imperative.

This amounts to a double whammy against stem cell research.

"At the present time, I don't think we have enough documented, usable
cell lines to entice people into this field," says Berg.

James Battey, director of the National Institute on Deafness and
Other Communication Disorders, who heads the National Institutes of
Health's Stem Cell Task Force, contends that the restraints leave
plenty of room for researchers.

"There's an enormous amount of basic research that can be done and
needs to be done before anybody anticipates any clinical trials,"
Battey says.

Among the basic-research questions: How do you drive human embryonic
stem cells to differentiate in a particular way—to be heart muscle or
to produce dopamine in the brain, for instance? How do you then
generate a pure population of the desired target cells? How do you
assure that the cells will be long-lived? How do you prove, in animal
models of disease, that they are effective therapies?

"All of these studies can be done right now, with human embryonic
stem cell lines that you can order today on the NIH registry," Battey
says.

Battey also challenges the contention that researchers are being
scared away. At a meeting in London in January, however, he and
research-funding officials from seven other nations agreed that a
shortage of scientists trained to work with stem cells is a major
problem. "That is probably the rate-limiting factor right now in
moving the research agenda forwards," Battey says.

And political uncertainty is one of the reasons for the shortage.
"These are careers," says Kevin Wilson, director of public policy for
the American Society for Cell Biology, and vice president for
legislative affairs of the Coalition for the Advancement of Medical
Research. "Is a scientist going to get involved in a career field
that could become against the law?"

As Wilson notes: "It's not a warm and fuzzy environment."

. . .

SOURCE: The Genome News Network
http://www.genomenewsnetwork.org/articles/02_03/stem.shtml

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