By Lisa Seachrist
WASHINGTON - National Institutes of Health (NIH) director Harold Varmus told members of a bioethics commission that, after reviewing the laws governing fetal tissue and embryo research, he has decided to move forward with funding research using the newly derived human embryonic stem (ES) cells.
Varmus asked that the National Bioethics Advisory Commission (NBAC) deliver by March 1 recommendations to the NIH on how to establish adequate guidance for the research. "I would urge you to consider the terms under which we can fund this research separately from the longer-term issues," Varmus told NBAC.
"We believe that, when something as promising as stem-cell research is available, we need as many talented individuals working in the arena as possible."
Varmus said he has had discussions with a number of congressional staffers and, so far, the response has been positive. In addition, he has discussed with the White House his intention to fund the research.
"We know that this is ethically sensitive territory," Varmus said. "We are going to be responsive to those with concerns."
At the request of President Clinton in a Nov. 14, 1998, letter, NBAC is considering topics ranging from whether the advances in human ES cell research raise new ethical issues to whether the sources of the cells bring about new and unique ethical considerations. Varmus wants advice from NBAC before funding any human ES cell research.
Fresh Discoveries Driving Debate
In early November, two teams of scientists tore down the boundaries of biomedical research. A research group from Johns Hopkins University, in Baltimore, and the University of Wisconsin, in Madison, announced that they had isolated human ES cells, which lack destiny and may become any cell type in the body. (See BioWorld Today, Nov. 6, 1998, p. 1.)
Less than two weeks later, researchers from Worcester, Mass.-based Advanced Cell Technologies Inc. announced that they had created an ES cell from the somatic-cell nuclear transfer of a nucleus of a differentiated human cell to an enucleated cow egg. (See BioWorld Today, Nov. 13, 1998, p. 1.)
The announcements of those discoveries moved cell therapies, tissue regeneration and certain gene therapies from the realm of scientific fantasy to a place on the foreseeable research horizon. In the wake of the announcement, researchers have begun to envision growing dopamine-producing nerve cells to cure Parkinson's disease; new cartilage to treat arthritic knees; and even new livers and kidneys.
However, all of the work to create these ES cell lines was conducted using private research funds. One group of researchers used cells from the urogenital ridge of aborted fetuses, and the other isolated the cells from the blastocyst of spare in vitro fertilization embryos that were scheduled for destruction.
The Hopkins research, using aborted fetuses, technically qualified for federal funding under laws guiding research using fetal tissue.
However, John Gearhart, the principal investigator who led that research decided that it was "too much hassle to seek federal funds."
The Wisconsin researchers, on the other hand, couldn't qualify for federal support, because of a rider that has been attached to the Health and Human Services Appropriations every year since 1995 prohibiting federal funding of human-embryo research.
Varmus called for NIH's general counsel to evaluate whether the agency could fund research using ES cells from either source, under current regulations. The general counsel ascertained that the laws that pertain to fetal tissue research would apply to ES cells, inasmuch as they can be considered fetal tissue.
The general counsel also determined that the agency could fund research using ES cells derived from embryos. In making that decision, the counsel was relying on the legislative language found in the appropriations rider.
That law protects any organism that is not protected as a human subject under current human subject regulations and that is derived by fertilization, parthenogenesis, cloning, or any other means.
Because pluripotent stem cells can in no way be considered an organism, the general counsel determined that the regulations didn't apply to the ES cell lines, irrespective of their origin.
"The appropriations rider would not apply to the stem cell lines [themselves]," Varmus said. "However, it does prevent us from funding research to produce the cells in the first place."
Prior to funding such research, Varmus said, he intends to get input from a wide variety of interest groups as well as ethicists.
NIH will create a series of guidelines that any researcher intending to use the ES cells would have to follow, in order to demonstrate that the researcher is aware of the limitations under which such investigations may be conducted and that the research complies with the guidelines.
In addition, Varmus said, he will set up a panel to ensure that such research complies with the law before it can receive federal funds.
NIH Aiming To Fund Stem Cell Research This Year
"We would hope to be able to support such research over the next several months," Varmus said. "There is no doubt that, once we start funding the research, there are going to be more researchers in this arena."
Austin Smith, a developmental biologist from the University of Edinburgh, in Scotland, urged the panel to take note of the need for federal funding of ES cell research.
"We need to bring the most talented people into the research as soon as possible," Smith said. "And we need to conduct the research in the view of the public."
Varmus said that researchers who seek to expand their work from non-human primates or mouse stem cells will likely be the first to get funding. New investigators will need to enter into the grant cycle, a process that takes between six and 10 months. n