NIH authorizes use of first human embryonic stem cells under new policy
The Obama administration on Wednesday approved the first human embryonic stem cells for experiments by federally funded scientists under a new policy designed to dramatically expand government support for one of the most promising but also most contentious fields of biomedical research.
The National Institutes of Health authorized 11 lines of cells produced by scientists at the Children's Hospital in Boston and two lines created by researchers at the Rockefeller University in New York. All were obtained from embryos left over by couples seeking treatment for infertility.
"This is a real change in the landscape," NIH Director Francis Collins said. "This is the first down payment on what is going to be a much longer list . . . that will empower the scientific community to explore the potential of embryonic stem cell research."
The move was hailed by supporters of the research as a long-awaited watershed that would finally allow scientists to start using millions of dollars in taxpayer money to study hundreds of lines of cells that had been put off-limits by President Obama's predecessor, George W. Bush, on moral grounds.
Under the Bush policy, federally funded scientists were limited to studying just a handful of cell lines that many criticized as deficient, had to erect cumbersome bureaucratic procedures to separate government-funded research from privately funded work and were sometimes even prevented from sharing ideas. Now, although embryonic stem cell lines will still have to be created using private funding, federal funding will be permitted for experiments using a much larger array of lines, vastly expanding the number of scientists and types of experiments permitted with taxpayer dollars.
"This is what we've been waiting for," said Amy Comstock Rick of the Coalition for the Advancement of Medical Research, the group that has been leading the lobbying effort to loosen federal restrictions on the research. "We've very excited."
But the announcement was condemned by opponents of the research, who argued that aside from being unethical the work is unnecessary because of the availability of adult stem cells and other more recently identified alternatives.
"Ethically, we don't think any taxpayer should have to fund research that relies on destroying early human life at any stage," said Richard M. Doerflinger of the U.S. Conference of Catholic Bishops. "But the tragedy of this is multiplied by the fact that no one can think what the problem is that can only be solved by these cells."
Collins, an evangelical Christian who has argued that science and religion do not need to be in conflict, defended the work.
"I think that there is an argument to be made that what is being done is ethically acceptable," Collins said, "even if you believe in the inherent sanctity of the human embryo."
Many scientists believe embryonic stem cells will yield fundamental insights into the underlying causes of a host of diseases and could be used to cure diabetes, Parkinson's disease, paralysis and other ailments. But extracting the cells destroys days-old embryos. In an effort to prevent tax dollars from encouraging the destruction of more embryos, Bush on Aug. 9, 2001, restricted federal funding to studies involving what turned out to be 21 stem cell lines that were already in existence.
Critics have long complained that those cells had shortcomings, such as defects that could make them dangerous to transplant into people. In the meantime, hundreds of newer lines have been developed that offer a host of opportunities. Many, for example, carry defects for specific disease and could yield crucial clues into how those illnesses develop and might be cured.
U.S. researchers who have wanted to study them had to use private funds and go through cumbersome bureaucratic hurdles, sometimes essentially creating parallel laboratories with carefully labeled and segregated staff and equipment to keep federal funds from being used for the experiments.
President Obama fulfilled a campaign promise in March by signing an executive order lifting the Bush restrictions and ordering the NIH to develop guidelines to decide which lines could be ethically used. In a political compromise, the guidelines finalized in July limited funding to lines created from excess fertility clinic embryos as long as they were deemed to have been obtained ethically. The lines have to meet a strict set of criteria, such as making sure couples were not offered any financial incentives, knew the embryos would be destroyed for research and were offered the option of instead donating the embryos to other couples.
Some proponents of the research criticized the guidelines for not going further and allowing, for example, federal funds to be used to create embryos specifically for research purposes or by cloning techniques. Federal funds are also still barred by Congress from being used to actually create the cell lines.
The final NIH guidelines created an elaborate process for vetting cell lines. Those that met the 15 criteria set forth by the guidelines could be approved by the agency's staff, while those that were more questionable because they were obtained under less stringent requirements common at the time would be vetted individually by a special advisory committee to the NIH director. It was unclear whether any of the 21 lines originally approved by Bush would qualify; so far only one has been submitted for review.
The 13 lines approved Wednesday met the basic requirements. Another 96 lines are awaiting vetting, including 20 lines will be considered by the advisory committee on Friday, and researchers have indicated at least 254 more will be submitted for approval, Collins said.
The NIH has already authorized 31 grants for about $21 million for research on human embryonic stem cells that were contingent on new lines passing government muster. Wednesday's approval will allow those scientists to decide whether to begin using the funding for those lines or await the approval of other, more appropriate cells. The grants are for a variety of research, including work aimed at developing cells that could be used to treat heart and nervous system diseases.
Many other grant requests have been submitted by researchers hoping to use some of the $10 billion the NIH received as part of the economic stimulus program for embryonic stem cell research, Collins said.
"What we're talking about today is just the beginning," Collins said.
Source: Washington Post
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