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Bush Policy on Human Stem Cells Faces New Challenges
By NICHOLAS WADE

Published: March 4, 2004

The White House's policy on research with human embryonic stem cells has been put under new pressure by the dismissal
of a leading biologist from the President's Council on Bioethics last week and by the development, announced today, of
new stem cell lines by a Harvard researcher.

At present, researchers who receive government financing can only work with human embryonic stem lines that were
derived from embryos before 9 p.m. on Aug. 9, 2001.

This was a political compromise that allowed stem cell research to begin but that also assured opponents of abortion
that no more very early embryos would be destroyed.

Dr. Douglas Melton, a biologist at Harvard, reported today in The New England Journal of Medicine that he had developed
17 new human stem cell lines with private money and would make them available to other researchers.

But scientists who are supported by government grants — the vast bulk of biomedical researchers — cannot use the cell
lines because they were derived after the White House cutoff date. An editorial in the journal says that Dr. Melton's
cell lines "should become part" of the approved list of lines registered by the National Institutes of Health.

Almost all scientists agree that if the promise of human embryonic stem cells is realized and they prove to be a
universal repair kit for patching up impaired body tissues, many new cell lines will need to be derived.

A critical question is whether the health institutes' registry now includes enough cell lines for researchers to
establish whether or not the cells can be used to treat disease. Dr. Melton said that he did not know for sure whether
research was being impeded by the present constraints, but that he had to develop his own lines, a choice not open to
researchers without private money.

Dr. Ron McKay, a stem cell researcher at the institutes of health, said the agency's cell lines had so far proven
suitable for his research, including a project to develop cells for treating Parkinson's disease. But he added that if
the project reached the clinical stage, perhaps in two years, it would be necessary to derive new and more appropriate
cells.

"It will become obvious that there are cell lines out there that have therapeutic value and it will be morally
impossible to support the case that you shouldn't be using them," Dr. McKay said.

The agency is trying to support research on human embryonic stem cells to the full extent they can within the law, and
there is no cap on research money for the field, said Dr. James Battey, chairman of the agency's panel on stem cells.

Of the 78 cell lines the institutes originally ascertained had been created before the August 2001 cutoff date, 15 have
been developed and are available and another 8 should come on line soon. Of the others, The Washington Post reported
yesterday, 16 lines have proven not to be viable. Dr. Battey said that kind of failure was completely expected in cell
line research.

When asked by a reporter what the institutes would do, if and when scientists proved that the method worked and needed
to develop new cell lines, Dr. Battey said, "When we come to that bridge, we will jump off it."

Last week, two members of the President's Council on Bioethics, which advises on stem cell research and other issues,
were told that their two-year terms would not be renewed. Their dismissal was protested in a letter sent to President
Bush by Dr. Arthur Caplan, an ethicist at the University of Pennsylvania and 131 others. One of the two departing
members, Dr. William F. May of the University of Virginia, issued a statement saying he had not expected to serve again
and praising the chairman, Dr. Leon Kass, for his evenhandedness.

The other member, Dr. Elizabeth Blackburn of the University of California, San Francisco, attributed her dismissal to
the fact that she had strongly dissented from some of the council's positions.

"He doesn't like his authority to be questioned," she said of Dr. Kass. Dr. Blackburn is a leading cell biologist and
one of the founders of an important new field to do with the structure of chromosomes.

Dr. Kass declined to comment, but referred reporters to an article he wrote in yesterday's Washington Post, in which he
stated that Dr. Blackburn's replacement was not political and not connected with any dissent she had expressed inside
the council.

SOURCE: The New York Times
http://www.nytimes.com/2004/03/04/science/04CELL.html

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