By Lisa Seachrist

Washington Editor

WASHINGTON - The National Bioethics Advisory Commission (NBAC) submitted its final report on the ethical use of human stem cells in research to President Clinton last week.

Consistent with much of its deliberation over the past 10 months, NBAC supported the use of federal funds for the creation of stem cell lines from "spare" embryos left over after in vitro fertilization (IVF) procedures. In addition, commissioners recommended the creation of a new regulatory body to oversee the derivation of these cell lines.

The recommendation comes in stark contrast to a statement issued by the president in July that indicated the administration wouldn't fund the derivation of stem cells and that the National Institutes of Health had the necessary regulatory and statutory authority to oversee research on human stem cell lines established in the private sector.

"The NBAC found no ethical difference between allowing federal funds for the use of stem cells and their derivation," said Michael Werner, bioethics counsel and director of federal government relations for the Biotechnology Industry Organization (BIO). "They used the same ethical bar and didn't want to make the distinction between use and derivation. The Clinton administration is holding to its distinction."

Stem cells exist as the most fundamental cell type in development. Present in the early stage embryo or the primordial reproductive cells of a fetus, they can differentiate into any cell in the body. Researchers hope to use these cells to develop tissue therapies for a host of diseases.

In accepting NBAC's report, President Clinton made reference to the near limitless potential of these cells, noting in a statement, "The scientific results that have emerged in just the past few months already strengthen the basis for my hope that one day, stem cells will be used to replace cardiac muscle cells for people with heart disease, nerve cells for hundreds of thousands of Parkinson's patients, or insulin-producing cells for children who suffer from diabetes."

Nevertheless, NBAC's charge to study the issue comes from the cells origins: either spare IVF embryos or aborted fetuses. Both of these sources prove ethically difficult. While federal rules allow the derivation of stem cells from aborted fetuses, Congress has placed an appropriations rider onto the National Institutes of Health's budget every year since 1995 preventing federal funding of research destroying embryos.

NBAC decided early in its discussions the derivation of human stem cells was part and parcel of the research using stem cells.

"Although some may view the derivations and use of [embryonic stem] cells as ethically distinct activities, we do not believe that these differences are significant from the point of view of eligibility for federal funding," the commission's report titled "Ethical Issues in Human Stem Cell Research" reads. "That is, we believe that it is ethically acceptable for the federal government to finance research that both derives cell lines from embryos remaining after infertility treatment and that uses those cell lines."

The commission found it ethically unacceptable to use federal funds to create embryos solely for research purposes.

However, Gillian Woollett, associate vice president for biologics and biotechnology for the Pharmaceutical Research and Manufacturers of America (PhRMA), questioned such a distinction, which was outlined in an executive summary of the report. The full text report will be made widely available in October.

"At the moment, the source of these stem cells - spare embryos from IVF clinics - aren't regulated at all," Woollett said. "The very thing you are so sensitive about - the creation of embryos - isn't regulated."

Eric Meslin, executive director for NBAC, said the commission recognized the unregulated status of IVF procedures in this country and recommended professional societies and trade associations develop and promulgate ethical safeguards and standards consistent with the principles in the report.

"The vast area of unregulated clinical activity in IVF is not within our ambit," Meslin said. "It is the obvious next step in the discussion."

NBAC recommended the Department of Health and Human Services (DHHS) establish a National Stem Cell Oversight and Review Panel to ensure federally funded research involving the derivation of stem cells is conducted in conformance with the ethical principles and recommendations established by NBAC. The new panel would be similar in makeup to the Recombinant Advisory Committee, which has operated under the aegis of NIH for 20 years. In order to avoid conflicts of interest that may arise from having the same entity that funds stem cell research, NIH, review that research, NBAC suggested the panel be located directly under the Secretary for DHHS.

Meslin noted NBAC "hopes that stem cell research is understood by the public." In order to facilitate that, NBAC recommends all protocols using stem cells be listed with the stem cell panel. However, only derivation protocols would be reviewed.

The idea of yet another federal review body doesn't sit well with industry. Werner questioned the need to create a new regulatory panel with every advance in technology.

"Our view is FDA can regulate this stuff," Werner said.

Woollett agreed and noted the recommendations have very little impact on the private sector.

"It's not apparent from the summary that there is any incentive for the private sector to be involved and that's a shame," Woollett said. "But, we do need to see the entire report before we can make a judgment."

In the meantime, Werner said the mere fact the commission supported federal funding for the work was important. He said, "The report shows a cross section of ethicists think stem cell research has great potential and should be supported."