Friday, December 4, 2009

NIH Approves First Embryo Stem Cell Lines under Obama Executive Order

Yesterday the federal U.S. National Institute of Health (NIH) approved the first new 13 human embryonic stem cell (hESC) lines for use in NIH-funded medical research. The approval is the result of an executive order issued last March, when President Obama overturned President Bush's ban of the use of new hESC lines in federally-funded research.

"I am happy to say that we now have human embryonic stem cell lines eligible for use by our research community under our new stem cell policy," said Dr. Francis Collins, director of the NIH. "In accordance with the guidelines, these stem cell lines were derived from embryos that were donated under ethically sound informed consent processes."

President Bush had banned the federal funding of any hESC lines produced after August 9, 2001, because of the ethical problems involved in creating and using such lines. The hESC lines are created by destroying the "excess" embryos produced by fertility clinics; after the embryo is destroyed, stem cells reproduce by themselves to make a stable and reusable line.

The NIH guidelines are meant to ensure that couples donating their embryos to researchers know that the embryos will be destroyed, are not offered any financial incentives to destroy them, and are given the option of donating their embryo to another couple. The actual destruction of embryos and the creation of hESC lines is still performed with private money; taxpayer funding is for the research conducted with these lines.

The 13 hESC lines approved yesterday were harvested by scientists at Children's Hospital Boston and at Rockefeller University. More that 20 additional stem cell lines may be approved on Friday; 96 lines are currently submitted to the NIH for consideration. Over $20 million in over 30 NIH grants pertaining to embryonic stem cell research had been restricted from use before this announcement.

Many have heralded embryonic stem cells as a miracle cure that could someday heal everything from heart disease to Alzheimers. Yet hESCs thus far have proved more apt to produce tertomas, tumors containing hair, teeth, and other tissues, than to produce any cure; human adult stem cells, which may be produced without destroying an embryo, have had far more success at curing a variety of diseases.

Dr. Collins said that one of the now-funded studies focuses "on the use of stem cells tor therapeutic regeneration of heart muscle cells damaged by heart." He continued: "Another will produce neural stem cells to learn to see whether they can be used for Parkinson's disease."

Interestingly, on same day that the NIH made its announcement, it was reported that another study has had great success using adult stem cells in treating those whose hearts were injured by a heart attack. Furthermore, human adult stem cells have already successfully been used to treat Parkinson's disease.

Non-embryonic stem cells have also been used to treat multiple scelerosis, blindness, lupus, diabetes, spinal cord injuries, and even to re-grow bones.

On the other hand, the FDA recently delayed a bid by biotechnology company Geron to conduct the very first clinical human trials with embryonic stem cells. Professor Lord Winston of Imperial College, an advocate of embryonic stem cell research, said in a 2007 lecture that scientists "often go rather too far in promising what we might achieve" and that he was "not entirely convinced that embryonic stem cells will, in my lifetime, and possibly anybody's lifetime for that matter, be holding quite the promise that we desperately hope they will."

A former director of the National Institute of Health bluntly declared earlier this year that "embryonic stem cells are obsolete."

Her pronouncement was spurred by the 2007 creation of "induced pluripotent stem cells" (iPS cells) from adult skin. Such cells have the ability to turn into any other kind of cell, like embryonic stem cells, but do not require the destruction of an embryo. "Already these reprogrammed cells have eclipsed the value of those harvested from embryos," she wrote, "because of significantly lower cost, ease of production, and genetic identity with the patient."

Richard Doerflinger of the United States Conference of Catholic Bishops therefore said that the NIH's announcement was "a political event, but the science is all moving in the other direction," toward iPS cells.

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