Even before the announcement in February 1997 that Ian Wilmut and his colleagues at the Roslin Institute in Scotland cloned a sheep, the subject of embryo research had been a political hot button. In 1994, a panel appointed by the National Institutes of Health (NIH) found techniques such as cloning to be unacceptable; however, the study of preimplantation genetic diagnosis and the fertilization process were found to be acceptable. Soon after the panel presented its report, then-President Clinton issued a directive prohibiting the use of federal funds for research that created embryos solely for research purposes. This ban did not apply to the use of embryos that were unused following couples’ attempts at in vitro fertilization (IVF). Subsequently, Congress passed bans on the use of federal funds by various government departments for any research that exposes embryos to the threat of destruction or research that is nontherapeutic.
The birth of Dolly the sheep and the announcement of the success of mammalian cloning through somatic cell nuclear transfer generated worldwide debate about the application of this technique to humans. On March 4, 1997, President Clinton announced that he was "issuing a directive that bans the use of any federal funds for any cloning of human beings." He also requested a voluntary moratorium on the cloning of human beings in the entire scientific and medical community.
There is agreement that the technique used to create Dolly should not be used to create another human being. However, there is little consensus regarding whether this technique should be used to create embryonic stem cells, which hold great promise for curing or ameliorating several devastating diseases including Parkinson’s Disease and Juvenile Diabetes.
In 1998, James Thomson and his colleagues at the University of Wisconsin reported that they had derived embryonic stem cells from an embryo donated by an infertile couple. A federal law enacted at that time prohibits federal funding of "the creation of a human embryo or embryos for research purposes; or research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death." The NIH issued final guidelines on stem cell research in 2000. One year earlier, the National Bioethics Advisory Committee (NBAC) had issued its final report recommending that "federal agencies should not fund research involving the derivation or use of human embryonic stem cells from embryos made solely for research purposes," nor should federal agencies "fund research involving the derivation or use of human embryonic stem cells from embryos made using somatic cell nuclear transfer." NBAC did, however, recommend "[r]esearch involving the derivation and use of human embryonic stem cells from embryos remaining after infertility treatment should be eligible for federal funding."
The NIH concluded that embryonic stem cells were not themselves embryos and, therefore, the prohibition of federal funding would not apply to the cells themselves once they had been derived from the embryos. The NIH also provided extensive guidance with regard to the details that must be provided for informed consent of donating couples including a statement that "the donation is made without any restriction or direction regarding" the recipient of such cells. The guidelines also specify the types of research that are ineligible for funding including: derivation of stem cells from embryos, research on stem cells used to create or contribute to a human embryo, and research using stem cells derived from embryos created solely for reproductive purposes.
President Clinton supported the NIH’s final guidelines. However, President, George W. Bush opposed them and on August 9, 2001, he announced his plan to allow funding for limited embryonic stem cell research on approximately sixty cell lines already in existence. The Bush plan does not allow for the funding of research using stem cells derived from embryos previously created for IVF and no longer intended for reproductive purposes by the couple, nor does it allow for the creation of embryos.
Sources for Embryonic Stem Cells
Embryos Remaining After IVF. Currently, there are more than 100,000 frozen embryos, an amount increasing annually by nearly 20 percent. Couples or individuals undergoing IVF often have more embryos created in a cycle than can safely be transferred to a woman’s uterus at one time. Many opt to cryopreserve or freeze their excess embryos. Once embryos are frozen, there are usually four options for their disposition: discarding or thawing them, donating them for scientific research, donating them to other couples, or maintaining them for the couple’s own future attempts at achieving a pregnancy.
Donating embryos to research, however, may be problematic. First, donation or payment for embryos to be used for research purposes is illegal in more than a half dozen states. Additionally, current restrictions on federal funding for research involving embryos impose a further limitation.
Another concern with research is the issue of informed consent. Generally, when a couple originally determine that they wish to donate their embryos to research, the type of research is not clearly defined. As such, there may be some instances where it would be necessary to go back to couples for their consent once the particular research project involving their embryos has been defined. The NIH and the American Society for Reproductive Medicine (ASRM) have issued guidelines on the informed consent process. Given the current federal and state legislative debates, however, it is unclear whether donation of excess embryos for research will remain an option for couples.
Creation of New Embryos. Another mechanism for developing embryonic stem cells is to create new embryos, embryos from which patient-specific stem cells could be derived. This process is known as therapeutic cloning.
Currently, thousands of women donate eggs annually to assist infertile couples achieve parenthood. Women are paid anywhere from $2,500-$5,000 per donation to undergo a month or more of physical exams, drug regimens, and intrusive questioning, all culminating in a surgical procedure to extract their eggs. The ASRM has recommended guidelines for egg donation including a position statement by its ethics committee on the appropriate payment to donors in order to avoid the possibilities of coercion or undue inducement. Nevertheless, college newspapers continue to advertise for the "perfect" donor, offering tens of thousands of dollars for tall, blond, academically superior young women.
In the reproductive context, the demand for egg donors far exceeds the supply. In part, this has increased the concern that pursuing therapeutic cloning would even further increase the demand for egg donors to the point where eggs would become commodities and women would become exploited. In testimony on May 15, 2002, before the Subcommittee on Criminal Justice, Drug Policy and Human Resources of the Committee on Government Reform, Judy Norsigian, executive director of the Boston Women’s Health Book Collective, expressed her concern that there are many potential risks to women who donate their eggs for therapeutic cloning purposes and none of the currently proposed legislation provides appropriate protections for these women. In prior testimony, she lamented that a lack of data on the health effects of ovulation induction drugs as well as the absence of regulation in the area of infertility services posed potential dangers to the women donating their eggs. She stated, "while some altruistic volunteers may be willing to be egg donors, the reality is that women with limited financial resources will be the primary providers of human eggs to enterprises that offer what appear to be lucrative payments." Additionally, due to the heightened demand for donors "it is likely that many women will become repeat donors, and that there will be a massive expansion in the use of women as paid ‘egg producer.’" (Statement of Judy Norsigian, Senate Health, Education, Labor and Pensions Committee, March 5, 2002).
This need to protect egg donors is not new; however, the increased demand highlights the urgency with which this issue must be addressed. Such protection should not be unduly paternalistic as respect for autonomy is still a cornerstone of biomedical ethics in this country. However, there often is a fine line between respect for autonomy and paternalism, highlighted in this context, which requires a delicate balance to ensure that the interests of all participants are safeguarded.
Conclusion
The benefits of stem cell research, including therapeutic cloning, may be far-reaching; however, the risks bear equal consideration. Pursuing this line of potentially beneficial inquiry should be done incrementally, to determine whether the technology is, in fact, as promising as believed. The ongoing debate and discourse will hopefully result in an outcome that enables the benefits of the technology to be realized while protecting against potential harms.