CLONE-IN 2001

On Wednesday, March 28, 2001, at 12:00 p.m. in 2123 Rayburn House Office Building, the Subcommittee on Oversight and Investigations will hold a hearing on issues raised by human cloning research. The purposes of the hearing are to: (1) assess the status of cutting-edge science relevant to human cloning research; (2) examine scientific, medical, ethical, and moral issues raised by human cloning research intended to create a child; (3) convene some of the best experts and advocates in the area of human cloning to discuss these issues with Subcommittee members; and (4) determine whether federal legislation is needed to regulate or ban human cloning research intended to create a child.

Witnesses 
The hearing will feature three panels of witnesses. The first panel will consist of scientists involved in cloning research, including representatives from the two scientific teams that claim they will clone a human being. The first panel witnesses include: Dr. Thomas B. Okarma, President and CEO, Geron Corporation (opposed to the human cloning experiments); Dr. Mark E. Westhusin, Associate Professor, Texas A&M University (opposed to the human cloning experiments); Dr. Rudolf Jaenisch, the Whitehead Institute and Professor of Biology, Massachusetts Institute of Technology (opposed to the human cloning experiments); Dr. Panos Zanos, Founder, Director and Chief Andrologist, Andrology Institute of America, (partner in the international scientific team that intends to clone a human being in two years); and Dr. Brigitte Boisselier, Scientific Director of Clonaid and Visiting Assistant Professor of Chemistry, Hamilton College (director and spokesperson for the cloning project supported by the religious sect called the Raelians). The second panel will feature federal witnesses: Dr. Kathryn C. Zoon, Director, Center for Biologics Evaluation and Research, Food and Drug Administration (FDA), and Dr. Thomas Murray, Director of the Hastings Center testifying for the National Bioethics Advisory Commission (NBAC). Dr. Zoon will testify concerning the FDA's jurisdiction and oversight over human cloning research in the United States. Dr. Murray will discuss the 1997 NBAC report and his views in opposition to the proposed human cloning experiments.

The third panel will feature witnesses who are ethical, religious, or policy advocates in the area of human cloning research. These witnesses include: Dr. Gregory Pence, Professor of Philosophy, University of Alabama at Birmingham (pro-cloning advocate and bioethicist); Dr. Michael Soules, President, American Society of Reproductive Medicine (opposed to the human cloning experiments); Mr. Randolfe H. Wicker, Founder, Clone Rights United Front, and Spokesman, Human Cloning Foundation (pro-cloning advocate and supporter of the international team effort); "Rael", Leader of the Raelian Movement, United States Raelian Movement (pro-cloning advocate and leader of the religious group supporting the Clonaid project); Dr. Arthur L. Caplan, Director, Center of Bioethics, University of Pennsylvania (opposed to the human cloning experiments); Mr. Jaydee Hanson, Assistant General Secretary, The United Methodist Church (opposed to the humancloning experiments); Sharon Terry, Vice President for Consumers, Genetic Alliance (opposed to the human cloning experiments); Mr. Mark Eibert, Esq., Law Offices of Mark Eibert (pro-cloning advocate); and Dr. Nigel Cameron, Strategic Futures Group, LLC, (will testify on foreign laws on cloning). 

Background
Cloning is defined as making genetically identical copies of a single cell or organism. The actual prospect of human cloning was first raised in February 1997 when Scottish scientist Ian Wilmut announced the successful cloning of an adult sheep, Dolly, using a technique that previously had not been fully successful in mammals. The technique, termed somatic cell nuclear transfer, involved transplanting the genetic material of an adult sheep obtained from a somatic cell into an egg from which the nucleus had been removed. A somatic cell is a cell of an embryo, fetus, child, or adult not destined to become a sperm or egg cell. In the human context, the cloning process involves replacing the nucleus from a female human egg cell with the nucleus of an adult cell from the individual who wishes to be cloned. The new nucleus is fused into the artificially created cell with a small electric charge. It is implanted into the womb of a surrogate mother and is intended to develop into a normal child -- but with a genetic profile identical to that of an existing adult. In the wake of this development, on February 24, 1997, President Clinton asked the National Bioethics Advisory Commission (NBAC) to address the legal and ethical issues associated with the use of this technology to clone a human being. Subsequently, on March 4, 1997, the President released a statement prohibiting the use of federal funds for cloning of human beings. Since the ban did not cover non-federally funded research the President also requested a voluntary moratorium on human cloning by privately funded researchers.

To date, mice, sheep, cows, goats, pigs, and a wild ox have been cloned, but not primates. In 1998, a scientist at a biotechnology company took a human somatic cell, inserted it into an enucleated cow egg, and started the egg dividing. He voluntarily stopped the experiment after several cell divisions. In 1999, a scientific team in South Korea claimed it created an embryonic adult human clone before halting the experiment. Some scientists plan to place a human clone embryo in a surrogate mother in order to produce the first human clone. In recent weeks there have been numerous press reports of two groups that have stated their intention to produce a birth of a human being through human cloning experiments within a year or two. One group, the Raelians, a Canadian-based New Age religious sect fixated with aliens, has been attracting press about their human cloning project called Clonaid. Late last year, the Raelians announced that they had found an American couple willing to pay $500,000 to clone their dead baby. Brigitte Boissellier, Clonaid's scientific director, has provided some information such as where the lab is located (allegedly in the United States), the costs, and the number of participants. Some of this information has been conflicting. Several publications, including Wired magazine and the New York Times magazine have published in-depth stories about the Raelians' human cloning project. These publications take the Raelians' announcement seriously because the Raelians claim to have a supply of donor eggs, surrogate mothers, financing, a laboratory, and a team of scientists. For these reasons, Time magazine concluded "[t]hough their outfit is easy to mock, they may be even further along than the competition. . ." The other group, an international consortium of scientists led by Dr. Pavos Zavos, a reproduction researcher, and his partner Severino Antinori, an Italian fertility doctor, who gained worldwide notoriety by enabling a 62-year old woman to conceive, have affirmatively stated their intent to create clones for infertile couples who were unable to have children. In January, Dr. Zavos announced that they "intend to clone the first human being." While there are inconsistencies surrounding the Clonaid project, there is little doubt of the intent of Dr. Zavos and Dr. Antinori to clone a human being.

Although the international team has said that it will conduct its human cloning experiment outside the United States, the Raelians at times have said their human cloning experiment is taking place in a laboratory somewhere in the U.S. If the Raelians' claim is true, it squarely presents the issue of what federal law, if any, is applicable to this experiment. There is no definitive federal statute governing privately funded human cloning experiments. However, on April 16, 1998, in response to an announcement by a scientist in the U.S. regarding his intent to clone human beings, FDA issued a statement addressing its jurisdiction over human cloning. FDA concluded that the somatic cell clone produced for the purpose of creating a cloned human being is a "product" subject to regulation by FDA. The basis for FDA's jurisdiction derives from its classification of the somatic cell clone as a "biological product" under Section 351(a) of the Public Health Service Act (PHS Act) and as a "drug" under Section 2019(g) of the Federal Food, Drug and Cosmetic Act (FD&C Act). Pursuant to regulations promulgated under the authority of these Acts, clinical research on investigational drugs and biological products can proceed only when an investigational new drug application (IND) is in effect. To date, FDA has not received an IND for the cloning of a human being. It should be noted that some legal scholars have questioned whether FDA's assertion of jurisdiction over human cloning is legally supportable. Currently there are four states that have laws banning the cloning of human beings: California, Louisiana, Michigan, and Rhode Island. In addition, there are eight states with pending legislation to ban human cloning: New York, Illinois, Indiana, Massachusetts, Missouri, Oregon, Texas, and Virginia. On March 1, 2001, the first international agreement to ban human cloning took effect upon the ratification by Slovakia, Slovenia, Greece, Spain, and Georgia. The measure, called the Protocol to the Convention on Human Rights and Biomedicine on the Prohibition of Cloning Human Beings committed signatory countries to prohibit by law "any intervention seeking to create human beings genetically identical to another human being, whether living or dead. To date, 24 countries have signed this protocol. Those countries are: Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Hungary, Iceland, Italy, Latvia, Lithuania, Luxembourg, Moldova, The Netherlands, Norway, Poland, Portugal, Romania, San Marino, Sweden, Switzerland, Turkey, and Macedonia. Furthermore, the following countries have laws prohibiting the cloning of a human being: United Kingdom, Japan, France, Denmark, Spain, Ireland, Germany, Israel, Malaysia, Colombia, Austria and Argentina. (See Appendix)

Although there has been no recent formal consideration by a federal agency over the issues raised by human cloning, the NBAC issued its June 9, 1997 report on human cloning discussing the various issues pertinent to this hearing. In its report, the NBAC concluded that "at this time it is morally unacceptable for anyone in the public or private sector, whether in a research or a clinical setting, to attempt to create a child using somatic cell nuclear transfer cloning." NBAC's conclusion was based largely on the serious safety issues associated with attempting to create a human being through cloning. Four years of animal cloning since the report have borne out the safety issues for both the clone and the surrogate mother. For the clone there are issues of physical abnormalities to psychological repercussions. Data from animal cloning studies show that somatic cell nuclear transfer in mammals has resulted in high rates of failure, high rates of spontaneous abortion, severe defects and deformities in the clone, and death soon after birth. Since a substantial number of clones will self abort, there are also health and safety concerns for the surrogate mothers. The technology used to clone mammals is still relatively new and thus the potential problems that may arise are not fully understood. For example, cloning experts and biologists have said that the cloning process seems to create random errors in the expression of genes and can produce any number of unpredictable problems.

While the report's conclusion was largely based on efficacy concerns, NBAC recognized the gravity of the ethical and moral issues associated with the cloning of human beings and the need for more scholarly review of these issues. The report also included recommendations, including the continued ban on federal funding in  support of any attempt to clone a human being as well as the voluntary moratorium for the private and non-federally funded sector. Further, NBAC recommended that federal legislation be enacted to prohibit the attempt to create a child through somatic cell nuclear transfer.

Issues
Issues at this hearing will include: Is it technologically possible to clone a human being at this time? Even if human cloning were possible, why should human cloning be pursued? What are the risks and benefits of human cloning? What are the scientific, medical, and ethical concerns over human cloning? Is FDA's asserted jurisdictional authority over human cloning sufficient to address these concerns?