In January, the National Institutes of Health (NIH) announced that it reads the law to indicate that it would be legal for NIH to fund research on stem cells derived from human embryos. The law applies to embryos, and stem cells are not embryos, even if they are derived from embryos. In February, 70 members of Congress sent a letter to the Secretary of Health and Human Services (which oversees NIH), Donna Shalala, protesting NIH’s interpretation.
On February 18, I wrote to NIH Director Harold Varmus and to the journal Science expressing support for stem cell research but urging Varmus to "resist the temptation to do an end-run around the ban on federal funding for research on human embryos" because even if NIH is correct that "the ban does not technically cover research on stem cells (Science 283 [22 January 1999]:465-467), funding research on stem cells derived from embryos is clearly contrary to the spirit of the law."
On March 30, I recieved a response via e-mail from Lana R. Skirboll, Director fo NIH’s Office of Research Policy. After giving some background on stem cell research and its potential benefits, Skirbol wrote,
After careful consideration, the DHHS concluded that because these cells are not embryos, current Federal law does not prohibit funds from being used for research utilizing human pluripotent stem cells.I was pleased that NIH responded to my letter and that NIH is proceeding with care. Although I support science and stem cell research, several news articles I have read make it seem that NIH is so eager to fund stem cell research that they are willing to ignore public opinion on the matter. I feel sure that people hostile to such research have reached even more ominous conclusions.The NIH understands and respects the compelling ethical, legal, and moral issues surrounding pluripotent stem cell research and is sensitive to the need for stringent oversight of this research – oversight that goes beyond the traditional rigorous NIH scientific peer review process. Three Congressional hearings have been held on this topic, and the National Bioethics Advisory Commission (NBAC) has been asked by the President to conduct a thorough review of the issues associated with pluripotent stem cell research, including all ethical and medical considerations. We are seeking the input of the public, Congress, and other interested groups as we develop our plan to oversee Federally funded research in this arena. We have received many letters from interested persons such as you and appreciate hearing your views on this matter.
The NIH is convening a working group of the Advisory Committee to the Director (ACD) to provide advice to the ACD relevant to guidelines and oversight for this research. The working group will meet in public session and will include scientists, clinicians, the lay public, ethicists, and lawyers. During their deliberations, the group will be asked to consider advice from the NBAC, the public, and scientists. Once developed, guidelines for research utilizing human pluripotent stem cells will be published in the Federal Register for public comment. We anticipate that the guidelines and the oversight process will be operational within the next several months.
It is important to note that the NIH will not fund any research using pluripotent stem cells until guidelines are developed and widely disseminated to the research community and an oversight process is in place. All researchers currently receiving NIH support have been notified, via the NIH Web site, NIH program staff, and the Deputy Director for Intramural Research, that they cannot use DHHS funds for research using human pluripotent stem cells until further notice.
President Clinton acted correctly, I believe, when he asked the National Bioethics Advisory Commission (NBAC) to consider the moral and social implications of stem cell research. However, NBAC’s pointed refusal to consider the ethics of research on human embryos in its report on human cloning does not inspire confidence. (NBAC reports are available on the World Wide Web at http://bioethics.gov/pubs.html.)
The legality of stem cell research is an important issue, as is the morality of research on human embryos and embryo-derived cells. I am not at all sure that the 100 or so subscribers to this newsletter will agree with my stance supporting research on human stem cells, and I leave open the possibility that I will hear arguments that will make me change my mind. However, at least two other important issues are lurking in this debate, issues that I think are, in the broad scheme of things, more important than whether NIH starts funding research on human stem cells.
The first issue is the degree to which members of the general public believe that that scientists ignore public opinion in moral matters. I frankly do not know how severe this distrust of science is right now, but NIH’s handling of the issue of stem cell research could either increase trust or destroy it. Even if scientists who want to pursue stem cell research are correct in believing that it is morally acceptable, they must convince the public before proceeding. Being right is not enough, and I fear that the ethos of science, in which being right is supposed to count for everything and public opinion is supposed to count for nothing, will be wrongly generalized from scientific matters to political matters.
I call the second issue "ethics under the gun." NBAC chair Harold Shapiro has stated publicly that one of the reasons NBAC did not tackle the embryo issue is that they did not have time; Clinton gave the Commission 90 days to prepare its "thorough" review of the ethics of human cloning. It was a thankless and impossible task, and though NBAC’s report is not perfect, it is admirable when the circumstances of its creation are taken into account. Any report created by NBAC will be important and influential, no matter how high or low its quality. It is unfair to NBAC and to the nation to rush to conclusions on these important issues.
I do not think that scientists eager to proceed with stem cell research are latter-day Frankensteins. However, whether a majority or a minority of Americans will share this opinion may depend on how NIH proceeds.
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