Seven prominent stem cell scientists, together with three patients, have filed suit against the U.S. Department of Health and Human Services (HHS) and the National Institutes of Health (NIH). They are charging that the Bush Administration's failure to fund work on human pluripotent stem cells is illegal and is causing "irreparable harm" by delaying potential therapies.
Last August, NIH issued guidelines to govern federal funding of work on human pluripotent stem cells (ScienceNOW, 23 August 2000). That paved the way for NIH-funded scientists to conduct research that can now be done only with private funds. But the guidelines are controversial because the cells--which in theory could be coaxed to become any cell type in the body--are derived from either human embryos or fetal tissue obtained from abortions. In February, the new Bush Administration asked HHS Secretary Tommy Thompson to review the guidelines; Thompson in turn told NIH to put its process for implementing them on hold (ScienceNOW, 16 April).
On 8 May, the scientists,* who work with human pluripotent stem cells using private funding, joined forces with actor Christopher Reeve (paralyzed by a spinal cord injury), advocate James Cordy (who suffers from Parkinson's disease), and Chicago business executive James Tyree (who has type I diabetes). In their complaint they ask the U.S. District Court for the District of Columbia to declare that the NIH guidelines are legal and to compel NIH to fund research on the cells.
The plaintiffs argue that by halting NIH's review process, HHS is failing in its "statutory duty to fund scientifically meritorious research projects." They note that the 1993 NIH Revitalization Act specifically bars the executive branch from blocking funding for research on transplantation of fetal tissue, and they argue that embryonic stem cell lines, as opposed to embryos, fall within the definition of fetal tissue. The patients charge that the HHS review is "preventing or delaying the development of potential treatments" for conditions such as paralysis, Parkinson's disease, and diabetes.
The government has 60 days to respond to the complaint, says Jeffrey Martin of Shea & Gardner in Washington, D.C., who is representing the plaintiffs pro bono.
--James Thomson of the University of Wisconsin, Madison, who first isolated pluripotent stem cells from human embryos
--John Gearhart of Johns Hopkins University, who isolated pluripotent stem cells from fetal tissue
--Dan Kaufman of the University of Wisconsin, Madison
--Douglas Melton of Harvard University
--Three researchers who have asked NIH to certify that cell lines they have derived meet the guidelines. They are Roger Pedersen of the University of California, San Francisco, and Alan Trounson and Martin Pera of Monash Medical Center in Melbourne, Australia.