President's Action On Embryos Drawing Fire From Scientists

Clinton's ban on funds for most studies using fertilized human eggs short-circuits NIH'spolicy-making process Many scientists studying human reproduction and embryology are angry and disappointed over a recent White House move to preclude federal funding for most research involving human embryos--new support that had been recommended by an expert panel. They see the move as an attempt to appease the new conservative ma-jority in Congress, which has threatened legislation against such studies. They say promising work--on fertility, birth defects, development, and cancer--will go forward, but much more slowly than it otherwise might have (see story on page 6). The burden of funding for such investigations will continue to be borne unfairly by infertile couples seeking help from in vitro fertilization clinics in conceiving a child, they claim, as has been the case for many years. President Bill Clinton's December 2 statement specifically blocked the National Institutes of Health from providing funding for proj-ects using human embryos created for research purposes, but did not prohibit grants to work with so-called spare embryos, those left over after infertility treatments. Researchers say, however, that spare embryos probably will not be sufficient in number to meet experimental needs, even if funding for these studies is made available. "It's going to slow progress, obviously," says Joe B. Massey, director of Reproductive Biology Associates, an Atlanta-based fertility-assistance clinic where only 60 spare embryos are available for experimentation out of a total of about 2,500 embryos placed in frozen storage over the past eight years. "The government supports medical research in every other field except in reproduction. We were anticipating that we would finally get a legitimate share of funding for research in this area and not be constrained by politics. But that's not what's going to happen." The presidential directive was a surprise intervention into the policy-making process involving embryo research, ongoing at NIH since last February. Earlier the same day, NIH director Harold E. Varmus's advisory committee had voted to recommend to him a report from a subcommittee, the NIH Human Embryo Research Panel, finding specific areas of human embryo research to be ethically appropriate for federal funding under stringent review guidelines (F. Hoke, The Scientist, Nov. 28, 1994, page 1). Approved studies involved so-called research as well as spare embryos, up to the appearance during development of what is called the primitive streak, the earliest suggestion of a nervous system and, thus, of sentience, at about 14 days. A decision from Varmus is now pending--but within the limitations imposed by the president. "I was very disappointed [with Clinton's action], because it cuts out NIH funding for one of the most important areas of research going on at the moment," comments Brigid L.M. Hogan, science cochairwoman of the panel and a professor of cell biology at Vanderbilt University School of Medicine. An example given by Gary D. Hodgen, president of the Jones Institute of Reproductive Medicine and a professor of obstetrics and gynecology at Eastern Virginia Medical School, of an experiment that would not be eligible for NIH funding involves Down syndrome and the aging of immature human eggs, or oocytes. The risk that a child will be born with Down syndrome--in which a third chromosome 21 occurs, in addition to the two normally present in the child--is known to increase sharply with the age of the mother. To learn more about oocyte aging in the environment of the ovary, Hodgen suggests an experimental design in which eggs taken from a group of women in their 20s are frozen for, say, 20 years, at which time a second set of eggs is taken from the same women. The first set of eggs is then thawed and both sets fertilized. The resulting rates of Down syndrome in the two sets of embryos could then be compared. Because the frequency and degree of debilitation of Down syndrome is quite variable among individuals, the near identity of the two sets of eggs would be crucial to the success of such an experiment. The embryos, many viable but genetically flawed, would be created for experimental purposes only and would not be transferred to a womb for implantation. "So, I've made a proposal that is not trivial in its scientific content or its potential value to humankind," Hodgen says. "It surely is a serious proposal, and it is not one of idle scientific curiosity, yet it is very basic research. Would that get funded? I don't think it would." According to both Hodgen and Joe B. Massey, director of Reproductive Biology Associates, an Atlanta-based in vitro fertilization clinic, research that led to the new fertility- assistance technique called intracytoplasmic sperm injection, or ICSI, now in successful use at their clinics, would also not be fundable if proposed to NIH. In this recently developed procedure, a single sperm is injected directly into an egg, usually to aid couples unable to conceive because of male- factor infertility. Brigid L.M. Hogan, science cochairwoman of the panel and a professor of cell biology at Vanderbilt University School of Medicine, notes that an important line of research is under way in Australia, the United Kingdom, and here--under carefully drawn ethical guidelines--to develop ways to mature oocytes in vitro. Currently, in vitro fertilization procedures often involve an aggressive hormone stimulation protocol to accelerate the maturation process to cause the release of a number of eggs for retrieval. The powerful hormones used in the procedure, however, are not safe for all women and have been associated with an increased risk of ovarian cancer. The new techniques under development involve removal of immature oocytes by ovarian biopsy and subsequent in vitro hormonal procedures to bring the eggs to maturity. The only way to know whether the technique works, however, is to fertilize the eggs to see whether viable, healthy embryos result; so this work, too, would be unfundable by NIH. Hogan notes that most such research involving human embryos is now done outside the United States and raises the prospect of an ethical dilemma likely to face U.S. clinicians. "I'm sure [these techniques] are going to start being used in this country, once they've been shown to be successful," Hogan says. "Now, what sort of standard is this, that a country like the United States can start using, clinically, the end products of research that was said to be unethical [here] but is being done in other countries?" --F.H. Both supporters and opponents of research involving human embryos see in the president's statement an opening for taxpayer support for studies involving spare embryos. Among scientists, some welcome whatever federal money might be made available for such studies as a result, although they had hoped for more. Others, however, contend that embryos are human beings and inappropriate for use as experimental subjects, whether created for research uses or left over from infertility treatments. "President Clinton announced that no federal money would fund research on experimental embryos, those created specifically for experimentation," observes human embryologist C. Ward Kischer, a professor, emeritus, of anatomy at the University of Arizona College of Medicine. "He said nothing about spare embryos. But when you come right down to it, spare embryos are no different from experimental embryos. And I think it was somewhat disingenuous for him to include only experimental embryos [in his statement] and not to say anything about spare embryos." Rep. Robert K. Dornan (R-Calif.) sent Varmus two letters in June and September signed by more than two dozen other members of Congress--including new House Speaker Newt Gingrich (R- Ga.)--objecting to the idea that federal funds might be used to support human embryo research. Then, in a letter to Varmus the week after the November 8 elections in which Republicans gained majorities in both the House and the Senate, Dornan wrote: "The issue of human embryo research is extremely troubling to us. Given the new realities of Congress, many of the incoming freshmen will presumably feel the same way. So let it be known that we plan to use every legislative means available to prevent federal funds from being spent on grotesque research of this nature." "There are those people in the scientific community who are pushing for human embryo research," says Brian C. Keeter, press secretary for Dornan. "If Varmus decides to drop the issue this year, what's to say that it's not revisited next year or the year after? So, the congressman has indicated that he wants to put some type of finality on this issue through legislation. [And] it's very possible, regardless of what Varmus does, that there will be congressional hearings." Scientists complain that, in releasing the statement precluding funding for most human embryo research, the president is yielding too easily to political pressure. "It looks like President Clinton is receding in any boldness whatsoever and moving to a conservative position where he'll have less criticism," asserts Gary D. Hodgen, president of the Jones Institute of Reproductive Medicine and a professor of obstetrics and gynecology at Eastern Virginia Medical School. "The president's position, since the elections, in many places, has leaned politically to the right, and I think he's doing that again here." The next move on human embryo research is now in the hands of NIH director Varmus or, perhaps, of the newly constituted Congress. "At this point, the two big questions are, one, what is Dr. Varmus planning to do and when, and, two, will the Congress get into this act and, if so, how and when?" says Steven Muller, president emeritus of Johns Hopkins University and chairman of the panel. "Anything is possible. My hope is that Dr. Varmus will proceed to implement as he sees fit. There may be congressional comment, but I hope that there will not be any congressional action, because if there were it would be negative." Scientists say those who oppose research involving human embryos often perceive or characterize the work as that of "mad scientists" or worse. What many researchers describe as ethical, scientifically and socially important experimental procedures on very early-stage embryos is seen as repugnant by some critics. Such preimplantation embryos were determined by the NIH panel to warrant serious moral consideration but to lack the moral status of children or adults. >From early in the policy-making effort last year, NIH officials and panel members sought to bridge this chasm between what they saw as the dominant scientific view of human embryo research and that held by some members of the public. The health agency mounted a public education campaign to persuade at least some critics of the value and propriety of some human embryo research and to prepare the ground, politically, for successful implementation of a new funding policy. This public education initiative may have underestimated the staunch nature of the opposition, according to some scientists. Human embryo research has become linked to abortion in the minds of many critics. "I don't know if education would change their minds [about human embryo research], because it's so tainted by the very deep issue related to abortion," says Maria Bustillo, director of reproductive endocrinology at Mount Sinai Medical Center and immediate past president of the Society for Assisted Reproductive Technology. "If we could somehow separate them, it would be great. You can educate the public, but if they really feel that we're killing a baby, I don't know how you can change that. It's kind of insurmountable. "Certainly, education would help, because there are a lot of people who don't understand [the difference between the two], who perhaps don't feel as strongly as the people saying we're killing babies in a dish." Others observe that it is not only members of the public who op-pose the re-search on these grounds. "The scientists first should be educated themselves," insists Micheline M. Mathews-Roth, an associate professor of medicine at Harvard Medical School researching a genetic blood disease called erythropoietic protoporphyria. "They should review their embryology and realize the fact that a human being starts when a human egg is fertilized by a human sperm. I find it very, very specious to say that some stages of human life are of less worth than others." Mathews-Roth adds: "The scientists tend to get a little bit-- how shall I say it?--overenthusiastic about the work that they want to do. Obviously, there is a lot of need for study of early development. But I think people are forgetting that there are some things we just can't do. We learned this 50 years ago, and I think we have to relearn it. This is what the Nuremberg trials [for Nazi war crimes after World War II] were all about." Researchers developing new in vitro fertilization procedures and other reproductive technologies are bitter about the fact that federal funding for their work has apparently become ensnared in political, rather than scientific, issues. "We've got to get politics off the backs of the scientists in order for scientists to perform good works," says Hodgen. "And I would offer this to those who would say, 'No one is watching them, they might do crazy things': That's not our history. We have been, whether it was with federal tax dollars or otherwise, good stewards of the public's trust. "We show this by having used our new technology to provide services to people that build families and build the probabilities of having healthy children. Those are the good ends of this work. That's what has occurred prior to this time. Why not suppose that it will continue? There are responsible people at work in this field as scientists and physicians. And their record, I believe, is laudable and deserves the trust of the president and the Congress."

President's Action On Embryos Drawing Fire From Scientists

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