Stem Cell Research
NIH Official Says No Cap on Dollars For Research on Embryonic Stem Cells
March 16, 2005
Source: BNA Medical Research Law and Policy
There is no fixed limit on the research dollars that the National Institutes of Health is prepared to apply toward stem cell research, Dr. James F. Battey, chairman of the NIH Task Force on Stem Cell Research, said March 9.
NIH funded about $24.3 million in grants for human embryonic stem cell research during fiscal year 2004, which represents a $4 million increase over fiscal 2003, he said. About $190.7 million of NIH's budget went to nonembryonic stem cell research in 2003. Battey said he hopes those numbers will continue to grow.
"There is no cap on the amount of money we are prepared to spend on stem cell research at the National Institutes of Health," he said.
Battey, who was speaking at a conference on the funding and regulation of stem cell research sponsored by the American Enterprise Institute for Public Policy Research, said the major limiting resource on funding stem cell research so far has been the pool of applicants, not research dollars.
"The money that is allocated is the direct result of the process of receiving investigator-initiated grant [applications], having them be peer reviewed, and, when they get a good score, funding the grants. If there were more people out there writing more grants, we would be funding more grants, and we would be spending more on human embryonic stem cell research. And the field would be moving ahead faster," he said.
Battey attributed the limited number of investigators to the unfamiliarity with an innovative and ever-growing field of research.
"It takes a while to launch a new field. People have to be trained. They're not necessarily out there and ready to go," he said. "I think part of what you're seeing here, certainly, is the chilling effect placed upon the community by the president's policy [limiting the number of embryonic stem cell lines that qualify for federal research funding]--I will not deny that. But part of it is just the growing pains of a new field of research."
NIH has taken several steps to overcome some of the challenges facing stem cell research, Battey said. The agency has been holding short-term courses on human embryonic stem cell culture techniques at five locations across the country. It also has developed a new program called the "Centers for Excellence for Translational Stem Cell Research," which assembles clinical researchers, stem cell experts, and transplant surgeons to expedite the translation of basic knowledge into clinical therapies for diseases.
"We need to bring them together now so when the time comes for them to collaborate on this and do the first phase one clinical trials, they'll know each other and [will] have had a chance to begin making their plans," Battey said.
Going forward, Battey said scientists will need to work on a definition of standardized human embryonic stem cell culture conditions that obviate the need for either mouse or human feeder cells. Those feeder cells, which include the 22 lines that qualify for federal funding, were found to be contaminated in a study published in January by researchers at the University of California, San Diego, and the Salk Institute (4 MRLR 101, 2/2/05 ). Those lines still are useful for conducting stem cell research at this phase, but may be problematic when scientists are ready to move to clinical trials involving human subjects, the study authors said.
"These feeder cells are obviously going to be an issue when it comes time for the [Food and Drug Administration] to consider cells for transplantation into clinical trials," Battey said. "They're not a deal-breaker, but they're an issue. And we would be much better off if we could reassure the FDA about exactly what [contaminants] these cells had [been exposed to], and that will come when standardized tools for cultures are developed."
Battey identified other issues that need to be addressed such as a further understanding of specialized cells, determining the critical factors for ensuring the long-term survival of cells transplanted into a host, understanding control of cell division, and defining the molecular pathways that control differentiation into specialized cells.
NIH Interface With State Programs
In addressing a question on how federal and state-level funding mechanisms will work in concert, Battey said he hoped NIH will be able to "synergize" with state-supported efforts.
A few states, including California and New Jersey, have approved large funding programs for embryonic stem cell research, and several others are considering such programs.
"We hope the states will do things that we cannot do--things that are not eligible for federal funding but the scientific community knows need to be done," Battey said. "My hope as we move forward is that we're not looking at a competitive environment, but we're looking at a collaborative and cooperative environment for stem cell research in this country. And I'm delighted that these efforts in these states are under way," he said.
A Webcast of Battey's presentation, along with additional materials from the AEI conference, "The Business of Stem Cells: Re-Examining Federal, State, and Private Funding and Regulatory Initiatives," are available at http://www.aei.org/events/eventID.1020,filter.all/event_detail.asp