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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." ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn