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NIH issues US embryonic stem cell guidelines, at last

But November's presidential election is likely to determine whether US scientists will ever be able to do this work with taxpayer blessings - and money.

By | August 29, 2000

US, August 29. The US National Institutes of Health has finally issued its long-awaited guidelines governing federally funded research with stem cells from human embryos. As expected, the guidelines are something of an exercise in ethical hair-splitting. The NIH says it will consider grant applications for this work provided the researchers (a) use cells only from frozen surplus embryos that would otherwise have been discarded by privately supported fertility clinics; and (b) do not derive the cells from said embryos themselves, but rely on supplies from privately funded scientists.

The guidelines clear the way — perhaps — for US biomedical scientists to use public money for the kind of research privately funded US researchers embarked on more than two years ago. In addition to permitting research only on surplus embryos, the new rules forbid embryo donors to be paid or to specify who can obtain their embryo's stem cells. The NIH did not want to encourage marketing of embryo cells or creation of embryos as potential treatments for kin.

The new rules are similar to draft guidelines the NIH first made available for public comment late last year. The response was a deluge of comments. At first they were said to be heavily negative but patient advocates countered with rafts of praise for the draft and persistent demands to allow the research on humanitarian grounds. Their arguments eventually prevailed.

"I think the attempt to find a compromise is reasonable. Restricting procurement to unwanted embryos makes sense since it shows respect for the creation of embryos but does not treat them as persons with the same rights as children and adults," says Arthur Caplan, who directs the Centre for Bioethics at the University of Pennsylvania.

The new guidelines were applauded by several advocacy groups that hope embryonic stem cells will provide the keys to victory in the fight against diabetes, Parkinson's disease, and dozens of other disorders, as well as a way to stave off ageing. President Clinton hailed them too, saying, ''I think we cannot walk away from the potential to save lives and improve lives, to help people literally get up and walk, to do all kinds of things we could never have imagined, as long as we meet rigorous, ethical standards.'' John Gearhart, of Johns Hopkins University, who first isolated human foetal stem cells in 1998 with private money, said "This is terrific. This is what I believe makes our country top of the heap in terms of scientific research.''

But the idea of doing research with cells from human embryos and foetuses has long been enmeshed in the perpetually polarized American debate over the moral status of the time between conception and birth. Thus right-to-life and anti-abortion groups were, predictably, appalled by the guidelines. "A good end doesn't make good an action that in itself is bad,'' the Vatican declared. The guidelines "sanction the killing of innocent human beings," said Judie Brown, president of American Life League.

The Christian Medical Association described the regulations as "a life and death word game," criticizing the NIH for making a "distinction between embryos created for research purposes and those created for reproductive purposes.'' They also emphasized that researchers working with stem cells taken from adults have recently reported notable successes, such as producing nerve cells from adult bone marrow stem cells — a point hammered hard by several groups opposed to embryo research. Furthermore, the CMA added that using a patient's own stem cells could avoid the problem of rejection by the immune system, sidestepping the moral quandary over using embryos or foetuses for research.

Some accused the NIH of timing the release of the guidelines for the late-summer doldrums in an effort to reduce outcries. The new rules were also released just a week after more permissive recommendations were made public by the UK Department of Health (see story). The UK government has endorsed those recommendations, which would not only permit research on embryonic stem cells, but also permit cloning of embryos for research purposes. They await action by Parliament in the fall. Guidelines are also being drafted in Canada, Germany, and Japan.

The NIH is putting together an advisory committee of scientists and ethicists to review grant applications for embryonic stem cell research. Its first meeting is planned for December. The schedule calls for any applications this body approves to be forwarded to a scientific advisory committee that meets in January. Applications getting the nod at the January meeting will then be sent on to individual institutes and go through their normal review processes. Thus public funding is unlikely to be available until the end of 2001 at the earliest.

The NIH guidelines will remain in force only if Congress and the White House do not intervene. So the fate of publicly funded stem cell research in the United States hinges on the relative political clout of the research's friends and foes — and is likely also to be influenced by how well research on adult stem cells continues to fare. Congress is not likely to take any action, for or against, before the November elections. After that, the future of American embryonic stem cell research almost certainly depends on which party is in power, in both Congress and in the Oval Office. Democrat Al Gore favours embryonic stem cell research and Republican George W. Bush does not. Ethicist Caplan observes, "The real fact is that these regulations mean very little. The issue will be resolved in the coming election."

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