WASHINGTON (Reuters Health) Aug 21 - Unless the Bush Administration can
come up with answers to questions raised by its new embryonic stem cell research
policy, some proponents of this type of research are saying they may have
to approach Congress for relief.
In his first presidential address to the American people, Bush said on August 9 that he would permit federal grants to be used for embryonic stem cell research. But the president said that research would be limited to the 60 stem cell lines created prior to his decision.
The Bush compromise, as the decision quickly is becoming known for its effort to establish a middle ground between scientists and abortion foes, immediately raised skepticism among proponents of embryonic stem cell research, who had seen information about only a dozen or so stem cell lines published in professional journals.
The number is a critical issue because academic researchers currently have access to only a few lines. Unless the federal government can identify and provide access to additional lines, these researchers say, they will not be able to proceed with publicly funded research.
According to Lawrence A. Soler, chairman of the Coalition for the Advancement of Medical Research (CAMR), this means the majority of research potentially could remain secret, which would significantly slow the progress towards viable treatments.
CAMR is a coalition of a number of research foundations, patient advocates and major research universities such as Harvard University and the University of Wisconsin, formed to ensure federal support for this type of research.
Soler noted that federal involvement is needed to ensure that research will be conducted according to the highest ethical standards and that the results will be shared. "With federal funding, you bring in the NIH [National Institutes of Health] and along with it ethical standards and the ability to share results," Soler said.
"You can't diminish the value of peer-reviewed research," agreed Kevin Wilson, director of public policy at the American Society for Cell Biology, noting that private companies are unlikely to request the participation of other researchers in designing their studies. "Peer-reviewed research will help move the ball faster."
Wilson added that private companies are likely to duplicate research, focusing on many of the same diseases and leaving others completely ignored. Although there is no denying that privately funded researchers are concerned individuals, they also have a responsibility to individual shareholders, Wilson observed.
The NIH insists that the Bush policy is fair and that researchers who are expressing concern are jumping the gun. "We are only a week past the president's announcement," an agency spokesman, who prefers to remain anonymous, pointed out in an interview with Reuters Health.
He said that the NIH already is working on a registry that will reveal the location of all the cell lines referred to in the president's announcement and eventually will hold discussions with all those entities to ensure public access. Although there is no definite time frame, the agency believes it probably can be ready for the fall grant deadline, he said.
This week the NIH began a series of discussions with top executives and scientists from stem cell laboratories around the world in an effort to seek pledges of cooperation. Still, it has yet to produce any information about the stem cell lines whose existence is being questioned. Bush reportedly mentioned those cell lines in his speech based only on the results of a quick NIH telephone survey.
Among the critical questions still unanswered are whether the existing lines will provide sufficient genetic diversity, whether they are stable enough to be used in research and what kind of deal publicly-funded scientists would have to strike with their owners to ensure access.
Bush administration attorneys are working on a solution to the third question, negotiating a agreement to give government scientists access to some stem cell lines that may be used by universities as a model for future negotiations. But some scientists say their lack of experience with transfer agreements could make the process more cumbersome than is viable in an academic environment.
Late last week, the world's largest scientific organization, the American Association for the Advancement of Science (AAAS), issued a statement urging the Bush Administration to publicly disclose both the source of the president's information and the basis of the thought process that led to his decision.
"Our immediate concern was that they show as many of the stem cell lines as they identified," Mark Frankel, director of the association's Scientific Freedom Responsibility and Law Program, told Reuters Health. "We need those answers sooner than later to establish confidence in the scientific community."
Frankel added that absent those answers, confidence in the administration would ebb and there would be a good chance that academic researchers might choose not to apply for research grants. "If I were a scientist, I would be very cautious about putting in for federal funding if there were too many constraints put upon me," he said.
While they await answers from the Bush Administration, proponents of embryonic stem cell research say they have not ruled out seeking relief from Congress, which will return from recess in September.
"It's not clear that all of the questions are going to be ironed out," explained Soler. He said the coalition will meet with members of Congress over the next few weeks to look at whether passage of legislation to overrule the Bush Administration's decision is necessary.
"The burden is on the Bush Administration to demonstrate that their policy is viable," said Frankel.
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