Coming clean on stem cells

The National Institutes of Health's human embryonic stem cell registry, which listed 71 cell lines eligible for federally-funded research, was "misleading" and "useless," a senior NIH official admits. Jim Battey, head of the NIH stem cell task force and director of NIH's Institute for Deafness and Other Communication Disorders (NIDCD), told The Scientist that including those 71 cell lines in the registry "probably was misleading" to the scientific community because it meant they were available for researchers when, in fact, only a fraction of that number were ready for shipment. "No statement was made as to how many vials of those cells were stocked away in a freezer," Battey said. "I don't think it was deliberately misleading, but it was often misinterpreted by the community. They figured if it was on the registry and eligible for funding that meant they could get the cells just by calling up and ordering them." On Nov. 18, 2002, NIH quietly removed 62 cell lines from the registry, leaving only nine derivations available from four suppliers. "Honestly, the old list was useless," Battey said. "What elements of the community are served by a list of cells that are in the freezer?"The stem cell registry was created following President Bush's Aug. 9, 2001 policy directive making limited federal funding available for human embryonic stem cell (HESC) research. While welcoming federal funding, scientists said the number of cell lines needed to conduct meaningful research was much greater than the policy would permit. In the weeks prior to and immediately after Bush's policy announcement, Tommy Thompson, secretary of the Department of Health and Human Services (HHS) had directed Lana Skirboll, NIH associate director for science policy, to canvass the international scientific community and determine the number of cell lines in labs and research institutions meeting the president's criteria. Skirboll's team uncovered 64 cell lines. "They're diverse, they're robust, they're viable for research," Thompson proudly told reporters the day after Bush's pronouncement. But scientists, legislators, and even some of the cell line suppliers challenged that contention. Less than a month later, Thompson admitted that only 24 or 25 cell lines were actually ready for research. And as time went on, it became clear that fewer than half that number were actually available.In reality, "the number of cell lines that were available for shipment in the spring of 2002 was one," Battey said – a cell line called H1 available from the WiCell Research Institute, affiliated with the University of Wisconsin. Representatives of the research community appreciate Battey's candor. "It's a positive sign that the folks at NIH clearly are going to be forthcoming, as we have known they would be," said Sean Tipton, vice president of communications for the Coalition for the Advancement of Medical Research (CAMR), an advocacy group for stem cell research and somatic cell nuclear transfer."I think there was some misinterpretation or lack of understanding by some people in the administration about the nature of these lines," said Anthony Mazzaschi, associate vice president for biomedical and health sciences research at the Association of American Medical Colleges (AAMC). But the NIH staff, he said, has always been straightforward. "They were honest about the varying lines and their status and characterization level and whether they would be readily available for distribution." NIH Director Elias Zerhouni says he is intent on advancing stem cell research involving both adult stem cells and HESC. Earlier this month Batty represented NIH at an international stem cell policy conference at the Medical Research Council (MRC) in London. In addition to the US and UK, representatives from Canada, Australia, Singapore, Finland, Sweden, and Israel explored ways to advance stem cell research.Discussions included creating a centralized data repository and facilitating collaborative research, including establishing an international HESC repository or cell bank in which suppliers would deposit cell lines available for research.The British fully intend to establish such a stem cell bank, Battey said. The NIH has already begun asking the US certified suppliers if they would be willing to deposit their cell lines in such a repository. It's too early to say what they plan to do, Battey added, because many of the suppliers are still scaling up.In a related development, NIH's Institute and Center (IC) directors have agreed to support creation of an HESC characterization facility that would provide standards and quality control for qualified HESC lines and to compare the properties of these lines with adult stem cells.At a Dec. 19, 2002 meeting, the IC directors recommended establishing a Human Stem Cell Facility to be housed in the laboratory of Ron McKay, a stem cell specialist and chief of the Laboratory of Molecular Biology, Division of Intramural Research, National Institute of Neurological Disorders and Stroke (NINDS). The facility, which is expected to be widely used, will be funded using a "school tax" approach, meaning the ICs will be billed based on program size without regard to usage."Dr. Zerhouni clearly understands about stem cell work and is committed to moving forward," Tipton said. "And learning more about how to characterize the lines will be an important component of that."

Coming clean on stem cells

US official admits most approved lines useless for now, supports proposed UK stem cell bank.

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