July 8, 2009
WASHINGTON (BP) -- The National Institutes of Health issued final guidelines on federal funding of embryonic stem cell research Monday that largely mirror an earlier draft, although it left a loophole that pro-lifers say could lead to ethical abuses, conflicts of interest and manipulation of infertile couples.
As expected, the regulations -- ordered March 9 by President Obama -- restrict federal grants for research to embryos that are 1) produced by in vitro fertilization for reproductive purposes, and 2) that are donated by couples who no longer want them and voluntarily provide their written consent. Stem cell lines eligible under President Bush also can receive funding.
Draft guidelines were issued in mid-April, beginning a period for public comment. Of the 49,000 comments received, approximately 30,000 expressed opposition to federal funding, the NIH said.
The guidelines also make clear that stem cells derived from therapeutic cloning, also known as somatic cell nuclear transfer, are not eligible for federal funds -- a stance that pro-lifers applauded.
But those same pro-lifers expressed concern that the NIH guidelines fail to require that the fertility doctor and the embryonic stem cell researcher be different people. In other words, the fertility doctor who derives the embryos can, by law, also wear the coat of embryonic stem cell researcher.
"As a general matter, the NIH believes that the doctor and the researcher seeking donation should be different individuals," the NIH said in its July 6 report. "However, this is not always possible, nor is it required, in the NIH's view, for ethical donation."
Pro-lifers, though, disagreed, arguing that a researcher who doubles as a fertility doctor will have a natural desire for more embryos in the lab -- and thus may lead infertile couples to create far more embryos than needed.
"The guidelines purport to have tight informed consent requirements, but don't even require the IVF doctor and the stem cell researcher to be separate persons, opening a gaping loophole for researchers to increase embryo production for their own purposes," Tony Perkins, president of the pro-life Family Research Council, said in a statement.
Embryonic stem cell research requires the destruction of the days-old human being and has yet to lead to any cures, even in the private sector. Critics argue that federal money would be better spent on adult stem cell research -- which does not involve embryos and has led to treatments for 73 ailments, supporters say -- and to induced pluripotent stem cell (iPS) research, a growing field whereby skin cells are reprogrammed into an embryonic-like state. Pro-lifers support both alternatives. "Dr. Oz" of Oprah fame told a nationwide TV audience he believes the "stem cell debate is dead" because of the promise of iPS research.
The NIH's final guidelines accompanied a transcript of all 49,000 comments and NIH's response to the most common comments.
Some commenters, NIH said, worried that couples could be paid for their embryos. To that, the NIH said it revised the guidelines "to state that there should be documentation that 'no payments, cash or in kind, were offered for the donated embryos.'"
On the other end of the ideological spectrum, some commenters suggested that the NIH broaden its guidelines so as to allow federal funding of stem cells "created expressly for research purposes" -- such as from therapeutic cloning.
"The Guidelines reflect the broad public support for federal funding of research using hESCs [human embryonic stem cells] created from such embryos based on wide and diverse debate on the topic in Congress and elsewhere," NIH said. "The use of additional sources of human pluripotent stem cells proposed by the respondents involve complex ethical and scientific issues on which a similar consensus has not emerged."
Therapeutic cloning, NIH said, requires women to donate eggs, "a procedure that has health and ethical implications, including the health risk to the donor from the course of hormonal treatments."
Although pro-lifers were thankful therapeutic cloning won't be funded for the moment, they were quick to note that NIH didn't completely rule it out for future funding.
On other matters, the final guidelines make clear that an infertile couple who gives informed consent can change their mind and "withdraw consent," provided the embryos can still be traced.
Perkins said the guidelines are full of problems.
"Embryonic stem cell research requires dissecting and commoditizing the youngest, most vulnerable humans," he said. "The new guidelines demanded by the President promote poor science, reflect bad health care policy, and do nothing to fund treatments with adult stem cells that are providing documented benefits for suffering patients. The guidelines implement a plan that will force taxpayers to foot the bill for research that involves human destruction, not healing."
Obama's March order overturned the policy by President Bush, which permitted federal grants for experiments on embryonic stem cell lines, or colonies, already in existence prior to his August 2001 order, while prohibiting research on any lines created after his order. Unlimited private funding was allowed to continue. Later in his administration Bush also signed orders providing federal funds for non-embryonic stem cell research.