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Abstract
In the genetic age, science often treads the waters of public sentiment. From gene therapy to genetically modified foods, issues involving DNA evoke ethical rhetoric and fiercely polarized opinions. The vortex driving the storm at the center of the debate seems to be the ultimate possibility of human cloning. On the one hand, cloning may help unravel some of the mysteries of our biological existence and lead to cures for disorders such as Parkinson's disease, spinal-cord injury, heart disease, and any other condition involving cell death. On the other hand, history has illustrated many times the potentially dire consequences of scientific progress that is regulated by ill-considered ethics and policy. Then again, at the core of the tension between the potential good of scientific knowledge and the potential ill of scientific progress gone awry may simply be the idea that cloning challenges our notion of self and the basic meaning of "being."
| Europe has ratified its treaty to ban human cloning. |
At any rate, there has been unrest since Dolly the cloned sheep made her entrance several years ago. In January 1998, as a response to Dolly, the Council of Europe (COE) drafted a Protocol on Prohibition of Cloning Human Beings as part of the existing European Convention on Human Rights and Biomedicine. The protocol commits countries that sign to ban by law "any intervention seeking to create human beings genetically identical to another human being, whether living or dead" without exception. The reasons, rooted in philosophical and safety concerns, are to protect the identity of human beings, preserve the random character of naturally occurring genetic recombination, and prevent instrumentalization through artificial cloning.
The treaty, signed then by 19 COE members, would become binding once ratified by five countries. By March 1, 2001, legislators from Slovakia (October 22, 1998), Slovenia (November 5, 1998), Greece (December 22, 1998), Spain (January 24, 2000), and Georgia (November 22, 2000) had ratified the protocol, making it the first international and only binding agreement to ban cloning. Twenty-four of the 43 COE states have signed, indicating their commitment to build the treaty into legislation within five years of signing.
| The treaty does not cover cloning cells and tissue for research. |
While the protocol covers human cloning, it leaves to individual countries the determination of the scope of the term "human being." Furthermore, the treaty states that it does not take a stand "on the ethical admissibility of cloning cells and tissue for research purposes resulting in medical applications, a field in which these techniques could turn out to be valuable tools." According to COE staff, questions regarding the use of embryonic cells in cloning techniques will be covered by an upcoming protocol on embryo protection. Additionally, Japan, Portugal, Germany, and Denmark have all banned human cloning outside of the COE protocol, although the three European countries mentioned did not sign onto the protocol.
Aside from the political, philosophical, and legal aspects of human cloning is the question of the science's feasibility and safety. The possibility seems imminent, for a few days after the COE protocol went into effect, two researchers announced in Italy the initiation of a human cloning project. Panos Zavos, professor emeritus of reproductive physiology and andrology at the University of Kentucky and director of the Andrology Institute of America, and his Italian colleague, Severino Antinori, plan to produce a viable embryo within a year to 18 months. Antinori is a fertility expert who is well known for helping postmenopausal women conceive. Zavos has assembled an international team of experts from the human reproductive field of the last quarter century, including a scientist who cloned mice for the first time in 1979, to develop the project. The purpose of the project is to help infertile couples have children.
| Legislation varies substantially. |
It is interesting to note that although bans have been legislated, the exact language of the laws, as well as their bases, differs. Germany, for example, declined to sign because it felt that the measure was weaker than its own already-existing law banning human embryo research. In survey, legislation banning cloning seems to showcase a variety as wide-ranging as opinions regarding the science and ethics. The laws range from the exclusion of cloning processes from patent protection in Australia to the prohibition of the application of federal funding to human cloning research in Missouri to penal prohibitions in California.
The United Kingdom, another nonsignatory nation, has gone through an evolution of policy when it comes to cloning. The House of Lords decided in January 2001 to allow for cloning of human embryos under the stipulation that clones not be allowed to live beyond 14 days. The policy was hailed by some as positioning Britain at the leading edge of medical research. In the arena of human reproductive cloning, however, the policy is not as permissive. In late April 2001, British health secretary Alan Milburn announced an initiative that would catapult human reproductive cloning from the licensing arena to the legislative one. At the time of the announcement, a license could be issued by the Human Fertilisation and Embryology Authority for cloning experiments. "At present in this country, human reproductive cloning is banned because the Human Fertilisation and Embryology Authority will not license it," Milburn said. "Human cloning should be banned by law, not just by license. The government will legislate in the near future to explicitly ban human reproductive cloning in the U.K." He also announced plans to create four genetics knowledge parks that would put "Britain at the leading edge of new genetics services and technologies."
| "Any attempt is uncertain in its outcome." |
In the United States, the issue has caused a ripple of activity in Congress. In a March 28, 2001, hearing held by the House Subcommittee on Oversight and Investigations, representatives from industry, academia, and religious and ethical communities presented their views. Rudolf Jaenisch of the Whitehead Institute for Biomedical Research has been a fierce critic of current efforts in human cloning, including those of Zavos. Human cloning would be "dangerous and irresponsible" due to high rates of fetal death and "evidence of abnormalities" in cloned animals. Meanwhile, Thomas Okarma, president and CEO of the biotech company Geron, drew attention to the distinction between the use of cloning technology to "create a new human being, from other appropriate and important uses of the technology such as cloning specific human cells, genes, and other tissues that do not and cannot lead to a cloned human being." The latter are "integral to the production of breakthrough medicines, diagnostics," and other diseases. Thomas Murray of the National Bioethics Advisory Commission reported on the Commission's recommendations. Although members may not agree on all of the "ethical issues surrounding the cloning of human beings, we nonetheless unanimously concluded that given the state of science, any attempt to create a child using somatic cell nuclear transfer, whether in the public or private sector, is uncertain in its outcome, is unacceptably dangerous to the fetus, and therefore morally unacceptable."
Following the hearing, several members of Congress introduced legislation prohibiting cloning for reproductive purposes. Of the six congressional bills introduced to date (with an additional one pending in the House of Representatives), four are from the House of Representatives and two are from the Senate. Already five states have enacted legislation to directly prohibit human cloning, and ten states have laws regulating research on embryos and fetuses that could also restrict cloning activities. Currently, in the United States, research using cloning technologies comes under the jurisdiction of the Food and Drug Administration (FDA). Researchers must submit an investigational new drug application request to the FDA, which the agency reviews to determine if the research can proceed.
| More protocols are pending. |
In Europe, the COE staff is developing a protocol on embryos in research that will be considered by the CDBI or Steering Committee on Bioethics in June 2001. The council is also working on four protocols on human genetics, which will be available on the COE Web site in June 2001, and a protocol on organ transplantation will be presented to the committee of ministers and the committee for adoption and signing in 2002.
Sanyin Siang works on a variety of issues at the intersection of science, ethics, and law at the Directorate for Science Policy Programs of the American Association for the Advancement of Science.
Julia Kuhl has done illustrations for the New Yorker and the New York Times, among others. She now lives in Heidelberg, Germany, with her neurobiologist husband and is working on a comic book - a Fulika atra (coot) version of Shakespeare's Hamlet.
Race Quickens for the First Human Clone - a short report from the April 2001 issue of Current Biology.
Don't Clone Humans!, Experts Assail Plan to Help Childless Couples, and Human Cloning Plans Spark Talk of U.S. Ban - several recent articles from Science discuss cloning.
Cloning Special Report - a collection of articles from the New Scientist.
Cloning Fact Sheet - provides some basic information with links to more in-depth articles. From the Human Genome Project Information site.
Bioethics.net: Cloning - includes introductory and in-depth articles. Maintained by the University of Pennsylvania Health System's Center for Bioethics, an educational group to advance scholarly and public understanding of ethical, legal, social, and public policy issues in health care.
Public Perspectives on Human Cloning - another thorough discussion of the potential social impact of human cloning. From Britain's Wellcome Trust.
Human Cloning: How Close Is It? - an assessment from fertility doctors, a bioethicist, and a geneticist. From National Public Radio's Frontline.
Use of Cloning Technology to Clone a Human Being - offers a short history of cloning legislation. From the U.S. Food and Drug Administration.
A Clone in Sheep's Clothing - the cloning of Dolly, from Scientific American.
Information on Cloning and Nuclear Transfer - from the Roslin Institute, where Dolly was cloned.
Human Cloning Foundation - "the official site in support of human cloning."
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