Federal research funding: NIH, FDA encourage new stem cell research.(Practice Trends)

BOSTON -- The head of the National Institutes of Health's stem cell task force has told scientists not to let Bush administration restrictions discourage them from applying for federal funding of embryonic stem cell research.

Money is not an obstacle, according to Dr. James Battey, Jr., director of the National Institute on Deafness and Other Communication Disorders at the National Institutes of Health (NIH) in Bethesda, Md. "If we got more grant applications for human embryonic stem cell research, we would be spending more money," he said at a meeting of the International Society for Stem Cell Research.

"We have put no cap on the amount of money we are prepared to spend on that area of research," he assured scientists at a special session on regulatory challenges and funding.

Joyce Frey-Vasconcells, acting director of the Food and Drug Administration's (FDA's) office of cellular, tissue, and gene therapy, similarly insisted that the FDA welcomes inquiries from researchers developing clinical therapies based on embryonic stem cells. "NIH approval for use of embryonic stem cells is not an issue for the FDA," she said.

"The issue for the NIH-approved [embryonic stem cell] lines is ... funding--federal funding," Ms. Frey-Vasconcells continued. "We [the FDA] do not fund anything. We do not give grants out. We regulate. And so we take whatever hits our door." The FDA will consider therapies based on embryonic stem cell lines developed in Europe and excluded by the NIH, according to Ms. Frey-Vasconcells. Its only issue is safety.

Although Dr. Battey and Ms. Frey-Vasconcells expressed strong support for embryonic stem cell research, leading investigators said that the strings attached to federal funding remain an obstacle to basic research and, ultimately, to development of clinical applications. Under Bush administration policy, only research that uses human embryonic stem cell lines developed before Aug. 9, 2001, is eligible for federal support.

"I don't think there's enough money to stimulate the field to really do what it needs to do," said Dr. Leonard I. Zon, president of the International Society for Stem Cell Research.