By Lisa Seachrist

Washington Editor

WASHINGTON ¿ In January, NIH Director Harold Varmus told the National Bioethics Advisory Commission (NBAC) that despite an appropriations rider banning the use of federal funds for human embryo research, the agency could underwrite the use of human embryonic stem cells in biomedical research.

More than 10 months later, NIH has published a draft guidance in the Federal Register for funding research using embryonic stem (ES) cells, calling for federal funding of the use, but not the derivation, of ES cells from embryos. The draft guidance document closely follows the discussions of the Working Group of the Advisory Committee to the Director in April.

The federal government¿s entrance into this entirely private research enterprise has been eagerly awaited by a number of patient advocacy groups seeking to reap the medical reward of ES cell research, such as tissue therapies to treat diseases ranging from spinal cord injuries to diabetes to Alzheimer¿s disease. The organizations see the funding as an opportunity to get the best and brightest into the field.

¿By having federal funding of stem cell research you are going to have the greatest number and the most qualified scientists pursuing this research,¿ said Joseph Cerquone, spokesman for the Patients¿ Coalition for Urgent Research in Washington. ¿In addition, moving the research to the public sector increases the odds this research will come under the closest scrutiny possible.¿

ES cells are capable of becoming any differentiated cell in the body, but are incapable of creating a human being when implanted into a woman¿s womb. Because the cells can¿t be considered embryos per se, NIH general counsel Harriet Rabb determined there were no prohibitions against funding research using ES cell lines.

The controversy comes from the source of the cells: either aborted fetuses, or ¿spare¿ embryos left over from in vitro fertilization procedures. Federal law currently permits the use of tissue from aborted fetuses to be used in certain research such as transplantation of nerve cells into the brains of Parkinson¿s disease patients. As such, the NIH draft guidance would permit the derivation of ES cells from aborted fetuses following the same ethical guidelines used for transplantation studies.

The NIH, however, won¿t fund the derivation of ES cells from spare embryos. That policy is in direct contrast to NBAC¿s recommendation. Nevertheless, the NIH guidelines call for funding research on embryo-derived stem cells only if the embryos were originally created for the purpose of infertility treatment, and were excess. Donation of such embryos must be voluntary with no monetary or other inducements offered and there must be a separation between the decision to create embryos for infertility treatment, and the decision to donate the embryos for research.

In addition, NIH won¿t fund research in which ES cells are used to create or contribute to an embryo, combined with an animal embryo, or used for reproductive cloning of a human being.

To oversee the research, NIH will establish a Human Pluripotent Stem Cell Review Group similar to the Recombinant Advisory Committee. NIH is seeking comments on the guidance for the next 60 days.