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RESEARCHER: Hans Keirstead looks at embryonic stem cells at the University
of California in Irvine. State funds have not been released for work in this
area.

California's stem-cell initiative on hold

The state's first-in-the-nation move to support embryonic stem-cell research
is stuck in court. Lawmakers are reviewing it, too.

By Daniel B. Wood | Staff writer of The Christian Science Monitor

LOS ANGELES - Jeanne Loring is all dressed up in her lab coat and has - so
to speak - nowhere to go.
As co-director of the stem-cell center for the Burnham Institute in La
Jolla, Calif., Ms. Loring has spent the past 15 months acquiring incubators,
biosafety hoods, and microscopes to tackle what she and colleagues feel is
the most compelling medical development in decades. They hope stem-cell
research can provide cures for diseases ranging from Alzheimer's to heart
disease.

But Loring and her coterie of 30 researchers - and similar operations across
the state - are being stopped in their tracks. A 2004 citizens initiative,
which catapulted California to the forefront of the nation's nascent
embryonic stem-cell research industry by approving $3 billion in state
funds, is stuck in court. Although arguments were heard last week and a
superior-court judge may rule in coming days - regarding proper state
oversight - the appellate process may go on for well over a year, legal
analysts say.
State legislators are also looking to address public concerns with a host of
new controls spelling out auditing procedures, possible conflicts of
interest, royalty agreements, and protection for human egg donors.
"We have stopped holding our breath and are not turning blue anymore," says
Loring, whose staff is taking pay cuts to keep grad students and
postdoctoral clinicians on payroll until state money is freed for the
project. The Burnham center has already won a grant of $1.5 million over
three years from the state agency created by voters. But until the court
case is settled, no such money can be dispersed.
The lab currently is supported by a combination of private money, foundation
grants, and National Institutes of Health subsidies. But it is not permitted
to use federal dollars, the largest portion of its funds, to work on new
embryonic stem-cell lines. "We are hot on the trail of the biggest, most
important development in science since the human genome project, but can
only work in fits and starts," Loring says.
Known as the Stem Cell Research and Cures Act, Proposition 71 was approved
by 59 percent of California voters in November 2004. The measure allocated
$300 million a year for a decade and created a state agency (called the
California Institute for Regenerative Medicine, or CIRM), as well as a
29-member citizen oversight committee.
Controversy and criticism followed almost immediately - partly because of
the scope and complexity of the idea, partly because no state had ever
attempted such an idea separate from the federal government. The Bush
administration prohibited federal funding for embryonic stem-cell research,
except on a limited number of existing embryonic stem-cell lines.
Other challenges included new guidelines regarding peer review, ethical
safeguards, and patient protections. There were also problems forging ahead
into a new realm of research that had not previously existed.
By most accounts, the CIRM has made significant progress on practically
every front. It has filled out its governing board with some of the top
scientists in the country and has held over five dozen public meetings to
air concerns. Chief among those concerns have been ethical questions
concerning the coercion of egg donors, the distribution of commercial
benefits from newly discovered procedures, and disclosure about conflict of
interest by board members.
"The CIRM has been subjected to an extraordinary amount of attention from
public, press, and legislators and has responded with extraordinary openness
through the past year," says R. Alta Charo, a law and bioethics professor at
the University of Wisconsin in Madison. She and others say the effect has
been to create policies exceeding federal standards in some areas.
But plaintiffs in the lawsuit argued last week that lack of direct
management by the state and control of taxpayer funds violates the state
constitution. The plaintiffs are a Christian conservative group, the
California Family Council, and a tax group, the National Tax Limitation
Foundation, which is being supported by the Life Legal Defense Foundation in
Napa.
"We think the state shouldn't have to pay for all this research and can't
sustain it," says Dana Cody, executive director of Life Legal Defense. "That
lack of sufficient oversight is what we are concerned about."
Defendants told the judge last week that the measure does meet state law
about oversight, and they hold that the plaintiffs' motivation is not legal,
but moral. "If you look at who is behind the suits, you will find they are
fundamentally opposed to the research and are doing anything they can to
stop it," says CIRM counsel James Harrison.
Besides the lawsuit, California's stem-cell foray has other serious critics,
even among supporters.
"Unfortunately as drafted, Prop. 71 [goes] a little light in the area of
public accountability.... The final product didn't have the safeguards it
should have," said state Sen. Debra Ortiz last Friday in two symposiums. Ms.
Ortiz has supported the measure from the outset but continues to express a
laundry list of concerns she feels were not understood by the public when it
approved the measure. She has been involved with a bill to codify reforms
that is expected to be heard in the Assembly Health Committee next month.
In the meantime, several universities have been moving ahead with private
donations. But national observers say the halt in research is enabling other
states to close the gap on California's once-giant lead in stem-cell
research.
Says Ms. Charo: "There has been a race among the states to copy California,
and this could help the locus of activity to move away."

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