- The Washington Times - Saturday, April 18, 2009

New stem cell research guidelines released Friday by the National Institutes of Health would ease restrictions on federally funded human embryonic stem cell research, allowing for cells culled from fertility clinic embryos that otherwise would be discarded.

The draft guidelines do not allow for the use of stem cells derived from embryos created just for science - and perhaps even those created using cloning techniques - that could make them genetically customized for a specific patient.

The announcement comes more than a month after President Obama signed an order to roll back George W. Bush-era restrictions on taxpayer funding of embryonic stem cell research. The executive order directed the National Institutes of Health (NIH) to issue new stem cell guidelines within 120 days.

“We believe strongly that the draft guidelines would set forth a range of opportunities that would greatly expand opportunities for human embryonic stem cell research that would be eligible for funding from NIH,” said the agency’s acting director, Raynard Kington, during a conference call with reporters. “We are grateful for the president’s executive order. We believe that it was the right decision to move in that direction.”

The new guidelines generally were applauded by medical researchers, though they were derided by some conservative groups.

“I think this is actually fine,” said Dr. Harold Varmus, president of Memorial Sloan-Kettering Cancer Center in New York City and a former NIH director during the Bill Clinton administration. “Obviously not everything is covered, but the essential things are there for making a lot more progress in stem cell research.”

Dr. Varmus added that the recommendations present a “huge improvement” over the Bush-era restrictions.

“This is a tremendous opportunity for working on a vast number of cell lines,” he said. “There may be a few that wish that these guidelines went further, but frankly this covers virtually everything that’s out there to be used.”

The National Right to Life Committee, one of the nation’s biggest pro-life groups, condemned the new set of guidelines, saying it “slides further down the slippery slope” of further exploitation of human embryos.

“Some may characterize the guidelines issued today as narrowly crafted, since NIH will not initially fund research involving human embryos who were created specifically to be used in research,” said the group’s legislative director, Douglas Johnson. “This seeming restraint is part of an incremental strategy intended to desensitize the public to the concept of killing human embryos for research purposes.”

Mr. Kington said there isn’t consensus within the scientific community at this time to significantly loosen the limits further.

He added that the NIH “considered the range of ethical issues” during the drafting process.

The guidelines, if approved, would require specific conditions to be met before fertility clinics could donate stem cells for research, including:

• All options pertaining to use of embryos no longer needed for reproductive purposes would be explained to potential donors.

• No inducements would be offered for the donation.

• A policy would be in place at the health care facility where the embryos were donated that neither consenting nor refusing to donate embryos for research would affect the quality of care provided to potential donors.

• Written consent would be obtained from people who sought reproductive services and who elected to donate human embryos for research purposes.

The guidelines will be published next week in the federal register and then open for public comments for 30 days. While NIH recommendations often are easily approved with little or no changes, the controversy surrounding the stem cell debate means Friday’s draft is not set in stone.

The agency said it would issue its final ruling by early July.

Embryonic stem cells are “master cells” that can morph into any cell of the body. Scientists are trying to harness embryonic stem cells to create replacement tissues that could treat - and possibly cure - ailments such as diabetes, Parkinson’s disease and spinal cord injury.

Those cells can propagate indefinitely in lab dishes, but initially culling them does destroy a days-old embryo, a result strongly opposed by many on moral grounds.

The Bush administration had limited taxpayer-supported research to a handful of embryonic stem cell groups, or “lines” - a policy the NIH said was stunting potentially groundbreaking science.

Mr. Obama last month lifted the restrictions but left it to the NIH to set ethics guidelines determining which cell lines would qualify for government funding.

Some scientists had hoped the NIH would allow use of stem cells derived from embryos created just for science. Some existing stem cell guidelines that are used in privately funded research - including guidelines from the National Academy of Sciences - are open to all types.

Ultimately, the NIH proposed limiting new grants to research that uses stem cells originally derived from fertility-clinic leftovers - the extra embryos that couples wind up not needing and often are thrown out. Only embryos donated voluntarily would be available for research.

Last year, the NIH provided about $88 million in research grants for embryonic stem cells research. It’s not certain how much more the agency may spend under the new policy.



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