Attempts to clone human embryos, to implant clonal embryos and bring them to term are almost certainly underway in the US at the present time. Advanced Cell Technologies (ACT) publicly promoted its efforts in both somatic cell nuclear transfer and parthenogenesis in what many thought a shameless effort to pump up their stock prices. Drs. Panos Zavos and Severino Antinori have been no less vociferous in seeking publicity, and investors, in their efforts at producing a baby through implantation of a clonal embryo. Because nuclear transfer techniques could be carried out in most well equipped IVF clinics, how many other such efforts ––unpublicized and unnoted–– may be underway is anybody’s guess. The chances are that eventually it will be tried.

All this goes on because, despite continued public concern and outcry since the cloning of the sheep Dolly in 1997, the US Congress has failed to enact legislation to ban or regulate human cloning through any means.

In July 2001, the House of Representatives passed HR 2505, the “Human Cloning Prohibition Act” which bans any attempt to clone a human embryo and establishes severe criminal and civil penalties. This bill was sent to the Senate for consideration in late July. Congress left on its second two-week break in six weeks on March 22, 2002, while cloning legislation was still in a holding pattern in the Senate, behind energy, the budget, and several other pending matters. Looming large after the break are the annual appropriations bills that may delay action on cloning until May or later.

Discussion in Senate hearings has been marked by an effort to draw a distinction between embryos cloned for the purpose of implantation and gestation and those created for the purpose of research. One Senator even insists that if you conduct somatic cell nuclear transfer ––which she calls SCNT (pronounced skint)–– to produce stem cells for research there is no embryo involved. This is what has led, in part, to the strange definition of human cloning found in S. 1758, the Feinstein-Kennedy bill: “The term ‘human cloning’ means asexual reproduction by implanting or attempting to implant the product of nuclear transplantation into a uterus.” Substituting, of course, the terms “product of nuclear transplantation” for “clonal embryo.”

The cloning bills currently active in the Senate are:

1. S. 1758: Originally co-sponsored by Senators Dianne Feinstein (D-CA) and Edward Kennedy (D-MA). The Feinstein-Kennedy bill permits creation of cloned human embryos through nuclear transfer techniques. It intends to prohibit implantation of such clonal embryos, providing criminal and large civil penalties for implantation, and to permit the use of such embryos for research purposes. An analysis of this bill by the International Center for Technology Assessment's legal staff indicates that the bill will probably not stop reproductive cloning and provides for no meaningful regulation of the use of clonal embryos for research.

2. S. 1893: Co-sponsored by Senators Arlen Specter (R-PA) and Tom Harkin (D IA). This bill is a ban on implanting human embryos that have been created through nuclear transfer techniques into a human uterus or a "substitute for a woman's uterus.” The bill provides criminal penalties and substantial civil monetary penalties. However, there are no restrictions or regulations on the creation, distribution, or sale of human embryos through any technology or process, until after the instant of insertion, at which point a criminal act has occurred. [N.B.: A similar bill introduced early in the session by Senator Ben Nighthorse Campbell (R-CO), S. 704, has been dormant since its introduction in early April 2001.]

3. S. 1899: Co-sponsored by Senators Sam Brownback (R-KS) and Mary Landrieu (D-LA). This bill is a mirror of the House bill and offers a "clean" ban on the creation of human embryos through nuclear transfer techniques. The bill provides criminal and substantial civil monetary penalties for creating a clonal embryo.

Many senators on both sides of the aisle are still undecided. The press is reporting that a multi-million dollar ad blitz is underway in targeted states across the country to change the public’s understanding of what cloning means and to convince people that it is possible to derive stem cells from cells of non-embryonic origin that are made to behave like embryonic cells. (Perhaps a "cell activated after somatic cell nuclear transfer.”) In addition, a publicity blitz from the research-industry-academia complex is promoting the idea that to ban or even slow efforts to clone human embryos is to deny life saving treatment to millions of suffering people around the world. Many of the undecided members of the Senate are waiting for an alternative to the current bills. Senators do not want to become known as "one of the cloners," but equally fear being labeled as obstructing research that might find a miracle cure for a dreaded disease.

The CRG and other reproductive health and women’s groups, as well as many social conservatives, oppose all forms of human embryo cloning for ethical, health, safety, or moral reasons. The progressive community has additional concerns about cloning human embryos and using them for research. Environmentalists, consumer groups, women's abortion rights activists, feminists, children’s health advocates, and others all want to see the unprecedented ethical, health, and regulatory questions raised by the idea of cloning human embryos resolved before any human embryo cloning is allowed. Following is a summary of the issues included in the debate. (1)

As a human community, we have never supported creating any human life form simply for its exploitation and destruction. There has never been public acceptance of, or government approval and support for, an industry of the creation of a human life form solely to harvest it for “spare parts.” The most recent poll as of this writing indicated that over 85% of people in the US oppose the creation of embryos by any method for the sole purpose of destroying them for any reason (June, 2001, an International Communications Research poll on the creation of cloned embryos for the purpose of their destruction).

As CRG Board Member Dr. Stuart Newman recently testified at a Senate committee (2), if cloned embryos are not sufficient for stem cell production, there will no doubt be a call for allowing these embryos to gestate up to several weeks so that stem cells can more easily be garnered. (3) The ultimate nightmare appears in the use of cloned “neo-morts,” “brain dead” late term fetuses or newborns kept alive and growing as research tools or sources for valuable human cells or tissues or as drug test subjects. There must be public hearings around the country with wide-ranging public participation on this key ethical issue before any human embryo cloning is allowed.

Those wanting to ban "reproductive" cloning but not place strict restrictions and controls on cloning human embryos fail to understand the important relationship between the two. Cloning human embryos for research could create tens of thousands of cloned human embryos. With this huge supply of embryos and an absence of effective oversight and control, it is virtually inevitable that the “legally” cloned embryos created for research will be used for illegal reproductive cloning.

How do we enforce a ban on the implantation of cloned embryos once they are in the marketplace? And how will we deal with the issues that arise if a legally cloned embryo is implanted in a woman’s womb?

Clearly, the time for restriction and enforcement is before we allow embryo cloning. We should enact strict standards for research cloning if it is found ethically acceptable and necessary, which 1: require inspection, evaluation and approval for embryo cloning research by a limited number of laboratories and researchers; 2: mandate a strict regime of supervision, monitoring and reporting from the initiation of a proposal for research, until the research is completed; and 3: require an unbroken record of custody of each and every cloned embryo from creation to destruction.

There are also potentially serious health risks associated with embryo cloning. Dr. Irving Weissman, chair of the National Academy of Sciences committee that prepared a report on cloning and stem cell research, estimates that it takes 50 human eggs to get one viable embryo. (4) All of these eggs will need to be harvested from women.

Egg harvesting can have significant health impacts on women. Of particular concern are the super-ovulating drugs, the numerous hormone treatments, and the extraction process itself. Potential risks include premature menopause, ovarian cysts and cancers, severe pelvic pain, rupture of the ovaries, bleeding into the abdominal cavity, acute respiratory distress, pulmonary embolism, and possible negative effects on future fertility.

Women who decide, for whatever reason, to become egg donors or sellers, must be fully informed about the risks involved. There must be federal legislation prohibiting the sale of human eggs and monitoring the health impacts of egg donation prior to any approval for research embryo cloning.

Cloned human embryos are patentable according to the U.S. Patent and Trademark Office. In addition, the sale, export, or import of human embryos is not prohibited. Aside from the aforementioned safety risks, cloning human embryos for use in research could turn thousands of women into paid egg “factories.” If we allow the patenting and sale of human embryos and human eggs, we corrupt and demean what it means to be human. There must be legislation passed banning the sale and patenting of human embryos prior to any cloning of human embryos for research.

We must wait to see what the US Congress and President Bush will do with the legislation pending this year. These are issues that demand careful consideration, extended debate, detailed planning, and broad consensus before the first actual cloned human embryo is produced.

The only bill currently under consideration in the Senate that takes the ethical issues seriously and provides the time we need to resolve the critical questions raised by human embryo cloning for our culture is the Brownback bill that bans the creation of embryos for any purpose through cloning.

(1) The following is excerpted and my personal rework from six issues regarding pending cloning legislation written for ICTA.

(2)Testimony before the United States Senate Committee on Health, Education, Labor and Pensions, March 5, 2002.

(3)This now seems even more likely since the recently published results of attempts to treat autoimmune disease in mice with stem cells from clonal embryos showed enormous rejection problems. )

(4) Senate staff briefing February 2002.

Doug Hunt is Director of the New Technologies Forum at the International Center for Technology Assessment. He previously served as the Program Director for Bioethics at the United Methodist General Board for Church and Society. He holds Bachelors and Masters Degrees on Science, a Masters degree in Theology, and a Doctorate in International Relations.