WASHINGTON - Health and Human Services Secretary Tommy G. Thompson acknowledged yesterday that little more than one-third of the embryonic stem-cell lines that President Bush had said were available to federally funded scientists are fully developed and currently adequate for research.
Facing senators skeptical of Bush's plan to limit government-funded research to existing embryonic stem-cell lines and no more, Thompson said he believed many of the 64 cell colonies the Bush administration has said were available would eventually become viable for research, but did not know for sure. He said those lines were in varying stages of development.
Still, Thompson said, even if those lines did not turn out to be usable, the 24 or 25 established lines were enough to conduct basic research into an area that scientists believe holds great promise for the treatment of a number of ailments such as diabetes, Parkinson's and Alzheimer's diseases and spinal cord injuries.
"We believe the number is sufficient," Thompson told the Senate Committee on Health, Education, Labor and Pensions.
He also announced that the National Institutes of Health had reached an agreement with the University of Wisconsin foundation that holds the patent on embryonic stem cells that would allow scientists access to the university's five stem-cell lines.
Thompson said the administration hoped the agreement, which allows the NIH to retain ownership of any intellectual property that might arise from its research using the cells, would serve as a model for other stem-cell owners.
Bush's announcement last month that he would limit federal funding to research on embryonic stem-cell lines that had been cultivated by the exact moment of his speech - 9 p.m. Aug. 9 - has sparked increasing wariness from scientists and lawmakers as questions about the quality and quantity of the existing cell lines have surfaced.
Sen. Edward M. Kennedy said yesterday that the "restrictive conditions" Bush placed on the research could "delay development of cures for dread diseases for many years at the cost of countless lives and immeasurable suffering."
The Massachusetts Democrat said he was surprised to hear Thompson acknowledge that only two dozen cell lines are available now, a fact that Kennedy said was "certainly in conflict with the words of the president."
But Kennedy, who chaired yesterday's hearing, said he needed more information about the quality and availability of the existing cell lines before he would decide whether to push for legislation that would allow a wider range of research.
Majorities in both the House and Senate support research into embryonic stem cells, the body's building-block cells. Stem cells have the ability to reproduce indefinitely and transform themselves into specialized cell types such as nerve, blood, heart or liver cells.
Embryos called form of life
Although many abortion opponents support the research because the stem cells generally come from embryos stored at fertility clinics that would otherwise be discarded, some religious conservatives oppose any research in this area because obtaining the cells involves the destruction of an embryo, which they view as the taking of a human life.
Bush's proposal was seen as a middle ground because it permits funding on stem-cell lines that already exist - which his administration numbered at 64 - but does not permit any new embryos to be destroyed to obtain additional stem cells.
Sen. Arlen Specter, a Pennsylvania Republican, called for an independent review of the stem-cell lines identified by the administration. They come from 10 university and private labs in five nations: Sweden, India, Israel, Australia and the United States.
"Apparently, many of the lines cited are not viable or robust or usable," Specter said. He argued that Bush had not been given accurate information by the NIH, which identified the 64 lines after conducting a worldwide phone survey.
Contamination lowers total
Several senators said Bush's plan was flawed because, they said, the existing stem-cell lines have been "contaminated," or grown using mouse cells and blood serum from cows as nutrients.
The exposure to animal cells could make them unusable in terms of therapies because the Food and Drug Administration requires strict safeguards to prevent transmission of animal diseases to people.
It's unclear if any of these cell lines were developed under guidelines acceptable to the FDA.
Thompson acknowledged that layers of mouse cells were used in the development of all of the existing lines. But he said such exposure would not impede basic research into stem cells.
"Before we can even get to the stage of credibly talking about therapies for diseases, we must conduct the basic research," said Thompson. "This will take years - three, possibly five, maybe eight."
Time lowers effectiveness
Maryland Sen. Barbara A. Mikulski expressed concern about Bush's plan to reap a continuing supply of stem cells from the available colonies, telling Thompson she had learned from researchers at the Johns Hopkins University that stem cells do, in fact, have a shelf life.
Harvard researcher Douglas Melton backed that assertion, testifying that his own decades of research with mouse embryonic stem cells have shown that the cells can lose their ability to become specialized and can become contaminated.
"A 150-year-old person may still be alive, but that person doesn't have the same potential of a 20-year-old," Melton told the committee. He said he was certain the 64 lines "will have been exhausted" by the time studies progress to the point of clinical applications.
To address the many patent and licensing issues that could be an obstacle to scientists, Melton suggested that the NIH create a repository of the stem-cell lines that qualify for federal funding, collecting the cell lines and negotiating the terms with the cell owners.
Thompson said he was "willing to look at that possibility."
But Thompson called the memorandum of understanding negotiated Tuesday night with the Wisconsin Alumni Research Foundation, which owns five stem cell lines and licenses them through a subsidiary, a "groundbreaking agreement" that shows how willing the cell owners are to make their materials available to researchers.
Thompson said the deal will allow researchers to work with the five stem cell lines developed at the University of Wisconsin and freely publish the results of their research.
Scientists, however, will have to negotiate separate agreements with the Wisconsin foundation regarding licenses and royalties if they want to use that research for commercial purposes.
Some of the most emotional testimony came from Rep. Jim Langevin, a freshman Democrat from Rhode Island and the first quadriplegic elected to Congress. Langevin, who recounted the handgun accident that severed his spinal cord and left him paralyzed at age 16, said the president's plan "impedes unprecedented, life-saving research."
He noted that the in vitro fertilization process creates more embryos than can be used. "To relegate these potentially life-saving cells to the trash heap after the arbitrary deadline of Aug. 9 is simply wrong," Langevin said.
But an opponent of stem-cell research who testified yesterday said that no human life can be considered surplus.
No 'spare' embryos
"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," said Kevin FitzGerald, a professor for Catholic health care ethics at Georgetown University.