107th Congress

Issues Concerning Cloning -- Hearing Before the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education -- December 4, 2001

Members Present

Senators Tom Harkin (D-IA), Chairman; Arlen Specter (R-PA), Ranking Minority Member; and Mike DeWine (R-OH).

Witnesses

Panel One: Senator Sam Brownback (R-KS)

Panel 2: Michael West, Ph.D., President and CEO, Advanced Cell Technology (ACT); Ron Green, Ph.D., Professor, Dartmouth University; Bert Vogelstein, M.D., The Johns Hopkins University (representing the National Academy of Sciences); and Phyllis Greenberger, Society of Women's Health Research.

Summary

Purpose of Hearing: The hearing was held to examine issues raised by a November 25 announcement that ACT, a small Massachusetts biotechnology firm, had succeeded in preliminary attempts to clone a human embryo for the purpose of deriving stem cells. The announcement generated considerable media and political attention and led to attempts to attach anti-cloning amendments to various pieces of pending legislation. The Subcommittee held the hearing to discuss both the scientific advance that had been reported, as well as the ethical issues raised by this report.

Opening Statements: Senator Harkin opened the hearing by noting that there has been a great deal of misinformation surrounding cloning, and some are inappropriately using the specter of cloning as an argument in favor of banning embryonic stem cell research. He said that he would soon be introducing legislation that would ban cloning for the purpose of creating a human being but would preserve the ability to conduct research using cloning technology.

Senator Specter urged the scientific community to "take an aggressive role in educating the American public...," suggesting that they are often too "inert." He also commented on the President's stem cell decision, stating that 64 stem cell lines are inadequate to realize the enormous potential of embryonic stem cell research. He said, "to have these matters inhibited on ideological grounds is, in my view, just unthinkable in the 21st century."

Statements of Witnesses and Questions

Panel 1

Opening Statement: Senator Brownback argued that cloning raises so many questions that there should be at least a 6-month moratorium imposed by the Congress so that some of these issues can be addressed. Chief among these is the question of the "moral significance" of the early human embryo. He argued that these are questions that should not be decided by small private companies.

Questions: Senator Harkin explored with Senator Brownback the differences in their views regarding the types of cloning activities that should be banned. Senator Brownback indicated that it would be insufficient to ban implantation of the cloned embryo without banning creation of the cloned embryo. Senator Brownback argued that once the creation of the embryo has been accomplished, it would be impossible to stop the implantation from taking place. Senator Brownback reiterated his concern that there is not enough attention being paid to the "moral significance" of the early human embryo. Senator Specter argued with Senator Brownback that "the embryo has significance, morally, if it leads to the creation of a person. But if it's sole purpose is for therapy, and it works, why not?"

Senator DeWine asked Senator Brownback whether an individual's intent in cloning would make a difference for purposes of imposing a penalty whether or not the person intended to clone a human being. Senator Brownback suggested that it would not be effective to impose a penalty based on a person's "thinking process." During questioning, Senator Brownback made two statements of note: 1) he is not opposed to in-vitro fertilization, and 2) he is generally supportive of President Bush's stem cell policy to permit federal funds to be used for research on already existing stem cell lines.

Panel 2

Opening Statements: Michael West opened his testimony by reviewing the potential scientific promise of cloning technology. He argued that the entity that is created by somatic cell nuclear transfer ought to be called a "preimplantation embryo" and affORDed a different status than an embryo created by the union of sperm and egg. He suggested that a line should be drawn at the development of the "primitive streak" at the time of implantation. Dr. West recommended against a cloning moratorium, suggesting that a 6-month delay in research would cost "potentially 541,800 lives that could potentially be treated someday with these technologies."

Dr. Green testified as Chair of the ACT Ethics Advisory Board. He said that the Board voted in favor of cloning embryos for the purpose of deriving stem cells because "these clusters of cells lack most of the qualities we normally equate with a human life. They are not the result of the union of sperm and egg. They represent an entirely new kind of biological organism never before seen in nature." Dr. Green argued in favor of a ban solely on reproductive cloning.

Dr. Vogelstein used a hair from his head to illustrate the problem of defining what human life is. He asked, "is that hair a clone of me? It's not such a trivial question, because each hair is genetically identical to me, to every other cell in my body." He said that using these hair cells to generate cloned stem cells is very different than a "clone of me." He added that, due to tissue rejection problems, President Bush's stem cell policy will probably be inadequate to realize the full potential of stem cells without using cloning to derive stem cells. He closed by stating that to ban nuclear transplantation would be a giant step backwards in realizing the potential of stem cell research.

Ms. Greenberger testified in favor of therapeutic cloning. She argued that it will allow scientists to overcome the problem of tissue rejection for the purpose of curing diseases, like heart disease, which affect women in significant numbers.

Questions: Senator Specter opened the questioning of Panel 2 by asking Dr. West to clarify that his efforts to clone embryos for the purpose of deriving stem cells is not against the law. Senator Specter also asked Dr. West whether there is a possibility that within 6 months, some entity will engage in cloning for the purpose of creating a human being. Dr. West said that this is unlikely. He did say, however, that he would be "disappointed" if within 6 months he was not successful in creating heart cells and neuronal cells from stem cells derived from cloned human embryos.

The Senators spent a significant period of time exploring with the witnesses whether the entity created by somatic cell nuclear transfer is different from an embryo created by the "normal" union of sperm and egg. Dr. Green argued that there are subtle differences that "challenge" the use of the term embryo. Dr. West again argued for a line to be drawn at the moment of implantation in the uterus. Senator Harkin asked Dr. Vogelstein where the line should be drawn for purposes of a legislative ban. Dr. Vogelstein agreed with Senator Harkin's proposal to ban the implantation of a cloned embryo but to preserve the right to use somatic cell nuclear transfer technology to create an embryo to derive stem cells.

Senator Specter asked the witnesses whether the 64 existing stem cell lines would be sufficient. Dr. Vogelstein said that for a variety of reasons, we will need more than 64 lines-some created by somatic cell nuclear transfer and some created by other methods.

In closing, Senator Specter asked Dr. West to respond to statements made by former Director of NIH, Harold Varmus, that ACT issued its cloning announcement as a way to solicit additional investors. Dr. West denied this, offering instead that the purpose was simply to be open about the type of research ACT is conducting.

Prepared by Gemma Flamberg/OD/OLPA, January 10, 2002