Stem cell researchers caught in red tape
Muddled rules regarding federal funding get in the way of science, some say.
By Karen Kaplan, Erin Cline
LOS ANGELES TIMES
Sunday, August 13, 2006
For biologist Meri Firpo, the controversy over human embryonic stem cells
boils down to pens.
In one of her laboratories - the one that gets government money to study
federally approved stem cells - researchers are required to use Paper Mate
FlexGrips.

On the same day President Bush vetoed legislation expanding stem cell
research, he held a conference with families who had children by frozen
embryos, including 15-month-old Trey Jones from Cypress, California.

Some labs that receive federal funding to study stem cells have purchased
two sets of laboratory equipment - one to use for government-funded research
and the other for alternatively funded projects that don't carry as many
restrictions.

Just across the hall is a nearly identical laboratory set up with private
funds so she can study new embryonic stem cell lines that do not have
President Bush's seal of approval. Firpo requires lab workers there to use
Uni-balls to make sure no federally funded pen finds its way into forbidden
territory.
It's an admittedly peculiar situation, but Firpo, a professor at the
University of Minnesota, said she was not taking any chances. A willful
violation of federal policy could make her liable for criminal and civil
penalties. Even a mistake might imperil federal grants for her lab - and for
the rest of the university.
Bush's embryonic stem cell policy, which restricts federal support to
research involving about 20 usable cell lines, has created a logistical
nightmare for science.
Researchers who study both federally approved and unapproved stem cells have
had to buy duplicate equipment to conduct their experiments, then set up
elaborate systems to keep their work completely separate.
Some scientists say the cumbersome dual system - reaffirmed last month when
Bush vetoed a bipartisan bill that would have expanded funding to more than
100 newer cell lines - puts U.S. researchers at a disadvantage.
"This is a bunch of compliance red tape that is a real pain in the neck,"
said Dr. John Boockvar, who heads Cornell University's Neurosurgery
Laboratory for Translational Stem Cell Research. "It's hard enough to do
successful research without having to worry about all this stuff."
So far, federal funding agencies have yet to redress anyone for violating
their rules. But the fear that they would is palpable, because universities
rely on the federal government for nearly two-thirds of their overall
research budgets.
Don Ralbovsky, a spokesman for the National Institutes of Health, which
bankrolls the bulk of federal stem cell funding, said the government was
willing to be flexible.
If a researcher inadvertently mixes money, "we would work with them to
rectify the situation and make whatever restitution is necessary," he said.
Those words offer little comfort to developmental biologist Susan Fisher of
the University of California, San Francisco.
Fisher was conducting research in a converted pediatric clinic in 2002 when
a winter storm knocked out the power, shutting down the freezers that housed
the stem cell lines her group had spent two years cultivating.
The makeshift lab had no backup power. Her freezer at home wasn't cold
enough. She considered sending the precious cell lines to colleagues with
industrial-strength freezers, but all their labs were federally funded.
Her cells melted into puddles.
"I never calculated the manpower hours lost, but it was huge," Fisher said.
The federal stem cell funding policy was created in 2001, when Bush offered
what seemed like a deft compromise to a frustratingly divisive issue.
For the first time, he offered stem cell scientists a chance at federal
research funds - a substantial pool of money that includes more than $20
billion a year from the National Institutes of Health and $5 billion a year
from the National Science Foundation.
But he also had to satisfy social conservatives, who oppose work on human
embryonic stem cells because they cannot be harvested without sacrificing
days-old embryos. Each embryo is a life, they say, and to destroy one is
tantamount to murder.
To ensure that taxpayers would not pay for research that destroys embryos,
he restricted federal funds to 78 cell lines already in existence.
Many scientists, physicians and patients saw the arrangement as a way to
press ahead with their efforts to understand the mysteries of embryonic stem
cells, which have the ability to become any kind of cell in the body.
Learning to manipulate the cells might produce one of the biggest
revolutions in medicine, leading to therapies for such intractable diseases
as Alzheimer's, Parkinson's and juvenile diabetes.
"I thought it was a good policy because all of the lines that were available
were eligible," said Larry Goldstein, a professor of cellular and molecular
medicine at University of California, San Diego.
"Five years later," he said, "things have changed."
Out of the 78 so-called presidential cell lines, researchers later found
that about 20 were useable.
That was too limited to represent the variety of medical disorders and the
genetic diversity of patients. As some of the lines aged, they acquired
chromosomal abnormalities and other mutations that made them difficult to
work with. Because the lines were originally cultured with animal products,
many physicians worried they could never be used for human therapies.
A solution is to derive fresh cell lines. For some scientists, there is only
one way to go about that.
Massachusetts Institute of Technology geneticist Richard Young and his
colleagues at the Whitehead Institute for Biomedical Research in Cambridge,
Mass., are putting together a new laboratory with a $52,000 fluorescence
microscope, two $7,500 incubators, a $6,500 tabletop centrifuge and an
annual research budget of more than $1 million.
Much of it simply duplicates his existing lab. "We have to do it," Young
said. Otherwise, we "will lose our edge."
Firpo even installed a keycard security system for her private laboratory at
the University of Minnesota to keep out researchers who are funded entirely
by Uncle Sam.
Some of the scenarios scientists are contemplating seem flat-out ridiculous
given the collaborative nature of research.
If privately funded students make a discovery on an unapproved cell line,
can they share that data with those funded by the NIH? If a privately funded
researcher extracts proteins or DNA from an unapproved cell line, can they
be analyzed with federal money?
"We have to hire lawyers to give us opinions on this," Young said.
Goldstein of UCSD was so befuddled that he sent a list of questions to the
NIH in November 2004. He is still waiting for definitive answers.
"It is just obscene that the government establishes a policy that not only
restricts our ability to do valuable medical research, but then doesn't even
help us interpret the policy in a way that allows us to stick to it," he
said. "Everyone is making judgment calls."
Ralbovsky, the NIH spokesman, said the agency tried to be as helpful as
possible, but he acknowledged that there were many gray areas with no simple
answers.
Ambiguity has left scientists in constant fear of tripping up.
Jeanne Loring, co-director of the stem cell lab at the Burnham Institute for
Bomedical Research in La Jolla, Calif., is so wary of making a mistake that
she designed homemade labels for her incubators, stainless-steel biosafety
hoods and other equipment.
Items that she called "kosher" to use with any of the cell lines bear a
sticker with a cluster of cells surrounded by a green circle. Others
stickers, for equipment paid for by the government, depict cells in a red
circle with a slash through it.
Loring said she hadn't had to use any of the red stickers, "but they're in
the drawer in case we ever get any NIH-funded equipment."

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