WASHINGTON – The Bush administration acknowledged Wednesday that fewer than half the stem cell lines approved for federal funding are fully developed and ready for researchers.
Health and Human Services Secretary Tommy Thompson said more cell lines will probably be ready by the time federal grants are issued next year. But even if they aren't, he said, two dozen cell lines are enough to get the science moving. "That is adequate," he told a Senate hearing.
Thompson also said the administration had reached an agreement on patent issues that will allow federally funded researchers to work with existing embryonic stem cell lines.
The agreement with Wisconsin Alumni Research Foundation, which holds the patents on the method of isolating stem cells, removes one of the major barriers to the promising research.
Thompson defended the administration against criticism for its decision limiting federal research funding to the stem cell lines that already exist. President Bush imposed the restriction to remove the incentive for destroying any future embryos, which is necessary to create new cell lines.
Of the 64 cell lines approved for research, Thompson said 24 or 25 are ready now. The others are in earlier stages of development. "That is adequate," he said, "but I think we'll have many more."
Critics say Bush's restrictions will hold back research.
"Many of the lines cited are not really viable or robust or usable," said Sen. Arlen Specter, R-Pa., as the Senate Health, Education, Labor and Pensions Committee opened hearings on stem cell research. He accused HHS of not giving the president complete information on which to base his decision.
Specter and others have said they will try to lift the restrictions, although Bush appears to have satisfied enough people to keep Congress from acting.
Senators said the research may also be hampered because many of the existing stem cell lines were grown with the help of mouse cells. If any of this research is to turn into treatments, it will need approval from the Food and Drug Administration, which requires special safeguards to prevent transmission of animal diseases to people. It's unclear how many of these cells lines were developed with the safeguards in place.
Thompson said he does not know how many of the lines might be contaminated but suggested it might not matter. The federally funded research may simply lay the groundwork for future privately funded work that develops the treatments, he said. With private money, new stem cell lines can be developed with proper safeguards in place.
On the legal front, Thompson called the patent agreement groundbreaking and said it "gives us even more momentum and incentive to get to work."
Without an agreement, scientists outside the University of Wisconsin, where the first embryonic stem cell lines were produced, cannot conduct their own research, with or without federal funding.
Thompson said the deal was reached late Tuesday and will allow for researchers to work with the five stem cell lines developed at the University of Wisconsin. Researchers will be allowed to freely publish their results, although they will have to negotiate separate agreements with Wisconsin if they want to apply that research for commercial purposes.
The patent issue was one of several that critics of Bush's policy have cited.
If the actual number of usable cell lines winds up significantly fewer than 64, Bush's restrictions could jeopardize the promise of research that could aid millions of Americans, Kennedy said.
"Many in the scientific community are concerned that the president's decision ... will delay development of cures for dread disease for many years -- at the cost of countless lives and immeasurable suffering," said Sen. Edward Kennedy, D-Mass., chairman of the Senate committee.
A developed stem cell line comes from a single embryo, becoming a colony of cells that reproduces itself indefinitely. But scientists who work with some of these cells say many of the 64 are not yet developed and some may never pan out.
Embryonic stem cells are the basic building blocks for some 260 types of cells in the body and can become anything: heart, muscle, brain, skin, blood.
Researchers hope that by guiding the transformation in the laboratory, they can coax stem cells to make new cells that could be used to treat diabetes, Parkinson's disease, heart disease or other disorders.
Embryonic stem cell research is opposed by many who believe an embryo is a life and that destroying it for any reason is wrong.
As Wednesday's hearing began, Dr. Joseph Itskovitz-Eldor of the Technion-Israeli Institute of Technology confirmed that his lab had shipped human embryonic cells to outside labs without permission from the Wisconsin foundation that holds a patent on the cells. He said his institute did not need permission, although foundation officials have suggested otherwise.
Bush's decision permits research only on cells coming from embryos processed before the cutoff date. He also required that the cells be derived from embryos considered surplus at fertility clinics and which were donated for research, without compensation, by couples who were fully informed about the process.
Opponents of stem cell research also were testifying Wednesday.
"We do not consider it appropriate to take organs from dying patients or prisoners on death row before they have died in order to increase someone else's chances for healing or cure. Neither, then, should we consider any embryos `spare' so that we may destroy them for their stem cells," Kevin Fitzgerald of Georgetown University said in prepared testimony.