My name is Stuart Newman. I have been a professor of Cell Biology and Anatomy at New York Medical College since 1979, where I teach medical and graduate students and direct a laboratory in developmental biology. This is the scientific field that studies embryo development, cloning, regeneration, and stem cells. My work on the development of form and pattern in animal embryos has been supported over the past 25 years by grants from the National Science Foundation and the National Institutes of Health. I am currently the recipient of two Federal grants.

Since my student days I have also been concerned with the uses to which scientific research is put. Having become convinced that scientists, who are beneficiaries of public resources, have a deep responsibility to anticipate what lies down the road in their own fields and to serve as a resource for the public on the complex issues around applications of scientific research, I joined with other scientists, social scientists, women’s rights advocates, and environmentalists, to found the Council for Responsible Genetics in the late 1970s. The Council is now the Nation’s oldest organization scrutinizing and interpreting the new genetic technologies, and has worked to educate the public on the scientific and social hazards of proposals to introduce inheritable genetic modifications into humans, including the allied technology of human cloning. I have placed into the record several documents from the Council that relate to the issues at hand, including the Genetic Bill of Rights, which affirms, in part, that “All people have the right to have been conceived, gestated, and born without genetic manipulation.”

I will state from the outset that I, and the Council for Responsible Genetics as an organization, unequivocally support a woman’s right to make her own reproductive decisions. Therefore, while what I am here to tell you today calls into question technologies that manipulate, clone, and genetically alter human embryos, these views do not derive from any notion of the sanctity of the embryo, nor from attributing to it the status of a human being. Rather, our concerns derive from two distinct sources:
(i) the irresponsible promotion of another scientifically questionable biotechnology, in conformity with what is now a recurrent pattern of playing to investors’ hopes and patients’ desperation;
(ii) the destructive social consequences of moving down the technological path that begins with embryo cloning.

Specifically, cloning embryos for producing embryo stem cells will, by failing to deliver on its promises, inevitably lead to calls to extend the lifespan of clonal embryos so as to permit harvesting developmentally more advanced cells and tissues for research and potential therapies. The same well-intentioned imperatives that make some of you unwilling to deny patients who hope for relief by means of embryo stem cells will make you, or your successors, susceptible to demands for increased access to improved products of this work, up to and including full term clones from which to harvest organs.

I will try to lay out how this will happen. Embryo stem cells are derived from embryos that are less than two weeks old—the now proverbial “clump of cells in the bottom of a Petri dish.” If derived from a clonal embryo resulting from transfer into an egg of a patient’s somatic cell nucleus, the stem cells will be a genetic match for the nuclear donor. Transplants derived from such stem cells will be compatible with the immune system of these patients. Please note, however, that this will be of little advantage to patients with type 1 diabetes, whose condition causes them to immunologically reject their own insulin-producing cells.

While such genetically matched cells may be tolerated by patients with other conditions, there are still likely problems. Two decades of research on embryo stem cells in genetically compatible mice has yielded a handful of studies with modest therapeutic results—in all cases less than what has been achieved with grafts of non-embryonic cells. Despite great efforts, embryo stem cells never become just one cell type or coherent tissue, but differentiate into disorganized mixtures of cell types. Most importantly, they are genetically unstable. If placed in adult mice they cause tumors. There is every reason to believe that human embryo stem cells, including those from cloned embryos, would cause cancer in human patients.

To overcome this, if it is indeed possible, will take years of research. Some say it’s worth a try, and scientists and companies with patents on this technology are willing to make the attempt. However, science and medicine always gravitate toward better technologies. In fact, Dr. John Gearhart of Johns Hopkins University has isolated a different kind of human stem cell. These are derived from the developing gonads of 8-9 week human embryos, and could be obtained after elective abortion. Like the embryo stem cells, these so-called embryo germ cells can differentiate into all cell types. Most importantly, when transplanted into experimental animals they do not cause cancer.

On purely scientific grounds, embryo germ cells show greater promise than embryo stem cells. Now, if they were derived from clonal embryos they would be nearly perfect, again in a purely scientific sense. But interestingly, none of the advocates of permitting embryo cloning has raised the specter of growing clonal embryos for 8 to 9 weeks so that genetically matched embryo germ cells could be harvested. These embryos would, of course, no longer be clumps of cells in a Petri dish, and some supporters of embryo cloning here might object. Right now it would be a hot potato, but once we have clonal embryos for a while and have gotten used to the idea, who would turn a deaf ear to calls by patients and their loved ones for these superior therapeutics?

And once stem cell harvesting from two-month clonal embryos was in place, who could resist the pleas to extend the time-frame so that liver and bone marrow could be obtained from six-month clonal fetuses to cure sufferers of life-threatening blood disorders such as beta-thalassemia, or so that brain lining cells could be harvested from near-term fetuses to treat Parkinson’s sufferers?

I emphasize that all of this makes perfectly good scientific and medical sense. The only thing that stands in the way is a sense of propriety concerning the uses to which developing human embryos and fetuses may be put. Some of you may draw the line at the tiny clump of cells; others at the two-month embryo; still others somewhat short of full-term. Wherever each of you decides to leave this particular train, there will be others who will assert their right to take it to the next station. After Dolly the sheep was cloned, a British scientist suggested, tongue-in-cheek, that inactivation of brain-inducing genes could be used to produce headless full-term human clones for organ harvesting. To his surprise, Britain’s most prominent embryologist publicly replied, “Why not?” Short of saying no to embryo cloning, any line that you draw will be a moving boundary. Few in this room would go along with the more extreme possibilities, but what about future generations growing up in a world in which producing clonal embryos for spare parts is medicine as usual?

Not only this, but the scientific publications that will ensue if embryo cloning proceeds will enable those reckless individuals who have announced their intention to make full-term clones, and then genetically-“improved” clones, to do so. Those who think that handling clonal embryos as controlled substances in regulated laboratories will stop the transfer of the technology do not understand how science works.

This is my prediction: if embryo cloning is permitted, within a few years frustration over lack of progress in producing safe and effective therapeutics from embryo stem cells will lead to calls to permit harvesting of embryo germ cells from 2-3 month clonal embryos, and we may all find ourselves here again. The rest will be just a matter of time. But there are other possibilities. Stem cells derived from adult tissues and umbilical cord blood have already proved to be effective therapeutics in animal models and in clinical trials. There is less commercial interest around them since it is difficult to obtain patents on a patient’s own cells. Correspondingly, however, these cells are immunologically compatible with the patient from whom they are derived. It will take much additional work to make this technology practical, but scientifically, and societally, I am convinced that this is the way to go.

(submitted with attachments including: CRG statement on embryo research; the Genetic Bill of Rights; and the CRG position paper on human germline manipulation.