NIH pushes back stem-cell funding awards to next year
The Bethesda, MD-based National Institutes of Health (NIH) told Sen. Arlen Specter (R-PA) in October that the government expects to begin awarding funds for stem cell research sometime next year. Determined to get the issue back in the forefront, Specter, the ranking member of the Subcommittee on Labor, Health and Human Services, Education, and Related Agencies of the Committee on Appropriations, held a hearing to collect updated information on funding of the controversial science. It seemed to have worked because NIH rescinded its earlier announcement and will extend its research deadline until Nov. 27.
"This is a one-time extension," says Wendy Baldwin, MD, deputy director of extramural research. "We want to mainstream stem cell research with all of the other research that we fund."
Cell lines come with stipulations
Government funding eligibility regulations stipulate that cell lines must have been derived from human embryos before Aug. 9, 2001, and that the embryo can not have a chance for further development, such as an embryo scheduled for disposal by a fertility clinic.
In addition to the application extension, Baldwin announced that NIH had expanded the original list of 64 stem cell lines to 72. The Madison-based Wisconsin Alumni Research Foundation (WARF) helped expand the list of lines because it grew additional cell colonies from its existing cells. On behalf of the NIH, Baldwin faced Specter’s pointed questions about progress within the agency to implement President Bush’s plan to fund research on 72 stem cell lines identified by the administration as viable.
From stem cells to security
One stumbling block to handing out research dollars was the NIH’s sluggish ability to set up its Human Embryonic Stem Cell Registry web page. The site provides information on which lines are available and where they are located. And several days before the Sept. 11 terrorist attacks, Tommy Thompson, secretary of the U.S. Department of Health and Human Services, told members of the Senate Health, Education, Labor and Pensions Committee that the site would be ready "within the next two weeks."
When asked by Specter to describe the NIH’s problem, Baldwin responded that since Sept. 11, the NIH shifted a lot of focus to security issues. "We’ve had people pulled from different areas to work on bioterrorism, and we weren’t expecting that," Baldwin said.
Pressed further by Specter, Baldwin said it is likely that the web page would be ready in early November. The site can be reached at (http://escr.nih.gov). (See list of available research sites and stem cell lines.)
Since taking over the White House, the Bush administration has presented scientists looking for government money for stem cell research with obstacles. Under the Clinton administration, the government was willing to pay for such research as long as a private company collected the cells. The debate surrounding the issue captured national attention when members of the Bush team said Clinton’s executive order permitting federal funding of such research likely was illegal.
For months, political watchers became armchair biologists as the media debated and discussed what stem cell research is and whether it is ethical. Then on Aug. 9, Bush went on national television to say the government would pay for research on 72 existing lines located within 10 labs worldwide. Narrowing the funds to specific lines opened a can of worms that included questions about whether the lines are viable, and if they are, how would patent and ownership issues be worked out.
Carl Gulbrandsen, managing director of WARF, testified to Specter that WARF and its subsidiary, WiCell, have agreed to provide its human embryonic stem cells to federally funded researchers at a low cost, about $5,000 per line. WARF and WiCell have five lines included in Bush’s 72 acceptable lines. Gulbrandsen said the lines can be used for research purposes, but if a company seeks to commercialize a product from the research, it would have to seek a commercial license. "Our goal is to see this technology widely disseminated and developed," says Gulbrandsen. "We know that federal funding will increase the number of researchers who work with embryonic stem cells and that these researchers will bring the tomorrow of medicine closer to today."
Obstacles still ahead
Specter polled the scientists on whether they support therapeutic cloning since some stem cell research could involve such cloning that cannot produce humans. "If therapeutic cloning were made a crime, would that preclude research?" Bert Vogelstein, a professor of oncology and pathology at Johns Hopkins Oncology Center and the Howard Hughes Medical Institute in Baltimore, responded to Specter: "That would be an understatement."
Sen. Sam Brownback (R-KS) has introduced an amendment to the Labor, Health and Human Services Appropriations Bill (HR 3061) that would criminalize therapeutic cloning. The House voted 265-162 in support of legislation (HR2505) authored by Rep. Dave Weldon (R-FL) that bans therapeutic and reproductive cloning. Brownback’s amendment was slated for debate in November.
Specter said he was trying to gather information for debate purposes. "We all have been preoccupied by the attacks and anthrax, but we are dealing with a lot of lives that depend on the stem cell and therapeutic cloning issues," he said.
Many scientists believe that therapeutic cloning is central to the production of breakthrough medicines, diagnostics and vaccines to treat Alzheimer’s, diabetes, Parkinson’s, heart attack, various cancers, and many other genetic diseases.