New stem cell lines approved for federal funding
Thursday, December 3, 2009
The Obama administration has begun approving new lines of human embryonic stem cells that are eligible for federally funded experiments, opening the way for millions of taxpayer dollars to be used to conduct research that was put off-limits by President George W. Bush.
Launching a dramatic expansion of government support for one of the most promising but most contentious fields of biomedical research, the National Institutes of Health on Wednesday authorized the first 13 lines of cells under the administration's policy and was poised to approve 20 more Friday.
"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," said NIH Director Francis S. Collins. "Today's announcement is the first wave."
An additional 76 stem cell lines are awaiting vetting, and researchers have indicated that they plan to submit at least 254 more for approval.
The NIH has already authorized 31 grants worth about $21 million for research on human embryonic stem cells, money that was contingent on new lines passing government muster. The grants are for a variety of research, including work aimed at developing cells that could be used to treat diseases of the heart and nervous system.
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, Collins said.
"We've been waiting with bated breath to get started," said George Daley, a stem cell researcher at Children's Hospital in Boston who created 11 of the lines approved Wednesday. "We could do today what we couldn't do yesterday."
Bush severely restricted federal funding for human embryonic stem cell research because of moral objections to the destruction of human embryos to obtain the cells. Federally funded scientists were limited to studying 21 existing cell lines that many criticized as flawed and inadequate; had to erect cumbersome bureaucratic procedures to separate government-funded research from privately funded work; and were sometimes 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, once those lines have been scrutinized to make sure they were created from embryos obtained ethically. That will vastly expand the number of scientists and types of experiments using taxpayer dollars.
"This is what we've been waiting for," said Amy Comstock Rick of the Coalition for the Advancement of Medical Research, which has been leading the lobbying effort to loosen the federal restrictions. "We've very excited."
Opponents see 'tragedy'
But the announcement was condemned by opponents of the research, who argued that the work is not only unethical but 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, a geneticist and evangelical Christian whose appointment raised concern among some scientists, 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 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 diseases and could yield crucial clues into how those illnesses develop and might be cured.
U.S. researchers who wanted to study them have had to use private funds and go through complicated bureaucratic hoops, sometimes essentially creating parallel laboratories with carefully 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 donating them 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 create the cell lines.
The final NIH guidelines created an elaborate process for vetting cell lines. Those that meet the criteria set forth by the guidelines could be approved by the agency's staff, while those that are more questionable because they were obtained under less stringent requirements will 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 lines approved Wednesday -- 11 at Children's Hospital and 2 at Rockefeller University in New York -- met the basic requirements.