DATE: June 21, 2001

FROM: Colby M. May, Esq., Director, Washington D.C. Office
Daniel Barnes, Blackstone Fellow

RE: The "Stem Cell Research" Issue

In the early 16th century Ponce de Leon traversed the treacherous terrain of Florida in search of the fountain of youth. The goal of that journey was to discover an elixir which would rejuvenate the body. In the beginning of the 21st century, doctors may have just found that fountain inside each one of us. It is stem cells, cells within the human body which have the potential of developing into all types of human cells and tissue. Such cells may some day provide society with cures for nearly all human ailments and disease, helping invigorate our bodies. The remaining question, which this Memo will address, is whether we are following the right path, scientifically and ethically.

Part I - What is the stem cell debate about?
Stem cells are cells which have yet to decide on what specific type of human cell they will become. They are found in both embryos and in the adult human body. The popularity of in vitro fertilization has produced a large number of embryos which have yet to placed in a womb. Though prior administrations have addressed the issue of stem cell research, the current White House has yet to decide on its approach to such research, with respect to deriving the stem cells from embryos. Lastly, there are those in Congress who support and oppose releasing federal funds for research on the stem cells of embryos.

A. Stem Cells
"A stem cell is a [unique] cell [in] that [it] has the ability to divide (self replicate) for indefinite periods – often through the life of the organism." These stem cells can be found in embryos, fetuses, and adults. Unlike other cells within the human body, stem cells have the ability to develop from unspecialized into specialized cells. Given the correct signals, stem cells will give rise to the more than 200 different cell types that make up a human organism. Stem cells are the building blocks from which all human cells are derived.

Not every stem cell has the ability to develop into each of the cells that comprise the human body. "Pluripotent cells [are those cells which] have the potential to give rise to any type of cell, a property observed in the natural course of embryonic development." The embryo is initially comprised of these pluripotent stem cells, in addition to extra-embryonic tissues, placenta and umbilical cord, and as they begin to commit to specialized cell types, the human body begins to take form. The other main classification of stem cells are unipotent stem cells, or those which are capable of giving rise only to one type of differentiated cell. And of course there are those stem cells which can develop into more then one differentiated cell type, but not all cell types.
The search for pluripotent stem cells has lead scientists to embryonic stem cells [ES]. ES cells are derived from a five to six day old embryo, which is known as a blastocyst. At this stage, the embryo is comprised of two layers: the inner cell mass and the extra embryonic tissues which will form the placenta and other supportive cells. "Although these inner cells, roughly 20-30 cells, have lost the ability to form supporting tissues, they retain the ability to develop into any cell type found in the body and are considered 'pluripotent'." It is these inner cells which are the ES cells, capable of developing into any cell type, that are so highly prized by scientists.

The fully developed human body also contains stem cells. These adult stem cells are unspecialized cells that occur in specialized tissue; they are self-renewing and become specialized, yielding all of the different cell types of the tissue from which they originate. Adult stem cells have numerous sources including bone marrow, blood, the cornea and retina of the eye, brain, skeletal muscle, dental pulp, liver, skin, the lining of the gastrointestinal tract, and the pancreas. Some "evidence does suggest that, given the right environment, some adult stem cells are capable of being ‘genetically reprogrammed' to generate specialized cells that are characteristic of different tissues."

However, scientists have not been able to determine whether an adult stem cell has the same pluripotent potential of its younger counterpart, the ES cell. Thus scientists are desperately seeking ES cells.

B. IVF and the limitless supply of embryos
Over the past twenty years, infertile couples have turned to in vitro fertilization as a means to conceive children. Since 1981, more than 45,000 babies have been born, in the United States, using IVF procedures.

The process of in vitro fertilization results in excess fertilized embryos, which is due to the significant failure rate of fertilized embryos to attach, or implant, along the uterine wall of the female. To begin the process physicians will obtain the donors' sperm and around 10 eggs, six to eight of which will become fertilized, outside the womb, and produce an embryo. "Then, in order to avoid producing multiple-fetus pregnancies, physicians will only transfer 2-3 embryos to the uterus." The present debate is over which should be done with the remaining fertilized eggs/embryos.

Presently, the embryos are cryogenically frozen and stored for possible future implantation. IVF clinics usually agree to store frozen embryos for five years. It has been estimated that there are nearly 150,000 frozen embryos, with 19,000 being added each year. After the initial storage of five years, fertility clinics "offer the genetic parents the option of extending storage for a fee varying between $100 and $500 annually, implanting the embryos, terminating them, or donating them for some purpose [such as adoption or scientific research]." It is the decision as to whether a frozen embryo should be discarded, donated to research, or, in some cases, adopted that is garnering the most attention of the public debate. What should be the final resting place of the frozen embryo, the womb, the waste dump, or the petri dish?

C. The Legal History of Embryonic Stem [ES] Cell Research
During the advent of in vitro fertilization, the Department of Health, Education, and Welfare created an Ethical Advisory Board, or EAB, to consider applications for research regarding human IVF. No research was to be funded prior to review until first reviewed by the EAB. After holding that research involving human IVF was acceptable, the EAB was dissolved by the Department of Health, Education, and Welfare. For the next decade, no new EAB was appointed and "because federal regulations required EAB review of all IVF-related studies, the absence of a Board imposed a de facto moratorium on IVF research and other studies involving human embryos."

During the 1990s, the Clinton administration and Congress sought to increase the level of in vitro fertilization research. In 1993, Congress passes the National Institutes of Health Revitalization Act, which "reverse[d] the conditions for in vitro fertilization research: it could go forward unless disapproved." The passage of the Revitalization Act lead NIH Director Harold Varmus and Department of Health and Human Services (HHS) Secretary Donna Shalala to assemble the Human Embryo Research Panel, an ethics panel whose task was to determine which human embryo research projects should be federally funded. The panel's report to the NIH director endorsed a number of research areas which would be ethically appropriate; included in that report was support for the "derivation of stem cells from human embryos, as long as the embryos were either consensually donated or the result of clinical IVF."

The Panel's decision to allow federal funding for the destruction of embryos, in order to derive the embryo's stem cells, ignited negative political reaction. President Clinton limited the holding of the report by declaring that federal funds would not be used for the creation of human embryos for research purposes. Congress went much farther then the President in declaring its disapproval of the Human Embryo Research Panel's report. Congress attached a rider to the HHS appropriations bill of 1995 which prohibited federal funding of any human embryo research.

The rider, sponsored by Jay Dickey (R-AR), is known as the Dickey Amendment. The Dickey Amendment demands that no appropriated funds "may be used to support research which involves:

(1) creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 C.F.R. 46.208(a)(2) and section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b))."

Thus, federal law prohibits funding a research project which would destroy a human embryo. Since the harvesting of stem cells from an embryo, the process of removing the inner cell mass from the embryo, results in the destruction of the human embryo, no federal funding has ever been used for ES cell research.

However, 1998 brought advances in embryo-related research. Specifically, for the first time, ES cells were cultivated and grown outside the womb.

Consequently the Clinton administration sought to circumvent the Dickey amendment and bring federal funds to the ES cell researchers. Seeking legal advice, NIH Director Varmus asked HHS General Counsel Harriet Rabb to investigate any limitations on the breadth of the Dickey Amendment. In a memorandum to Varmus, Rabb insisted "that the federal law did not prevent [the] NIH from funding [stem cell] research, because stem cells met neither the statutory nor biological definition of a human embryo." Rabb's argument was elaborated in an HHS report entitled Fact Sheet on Stem Cell Research; it stated that "‘because pluripotent stem cells do not have the capacity to develop into a human being, they cannot be considered human embryos consistent with the commonly accepted or scientific understanding of that term.'" Federal funding of ES cell research was deemed to be in accord with the Dickey amendment because no embryo was killed while working with ES cells; the embryo was killed beforehand.

When the final NIH Guidelines for Research Using Human Pluripotent Stem Cells became effective on August 25, 2000, the Rabb distinction between research on stem cells versus research on embryos was utilized. The Guidelines stated that NIH funded research may "involve human pluripotent stem cells derived 1) from human fetal tissue; or 2) from human embyros that are the result of in vitro fertilization, are in excess of clinical need, and have not reached the stage at which the mesoderm is formed." Federal funds could be used for research on ES cells, as long as the embryos were created for fertility purposes and would otherwise be discarded. In keeping with the Rabb distinction, the Guidelines further stipulated that "NIH funds may not be used to derive human pluripotent stem cells from human embryos." Thus, as the Bush administration took over, the NIH was free to fund research using stem cells derived from embryos as long as the NIH had not funded the destruction of the embryo.

D. Bush Administration and Congress – the current political climate
When Presidential administrations change hands, the past policies of the previous administration are reviewed and opened to modification. Early this year, President Bush halted the implementation of the NIH Guidelines for Research Using Human Pluripotent Stem Cells, "saying he wanted to review the scientific, legal, and ethical implications of the research." Initially, it was thought that Bush would reverse the guidelines. This was based in large part on campaign promises not to fund ES cell research and a letter sent to the Culture of Life Foundation on May 18 which stated that he "oppose[d] Federal funding for stem-cell research that involves destroying human embryos."

However, political pressure in the form of lobbying organizations, elected officials from both political parties, and public opinion polls has mounted, increasing the political stakes. As the debate continues to rage, it is becoming more likely that the Bush administration will try to tack a course that brings a compromise between the pro-life and pro-research factions of the administration, and the public at large.

There are a number of compromises currently being considered by Bush Administration. The first option is "permitting federally backed experiments on a handful of cell types, called [cell] lines, that have already been identified, but banning public money to develop more." A second option would be to fund such research until scientists feel they have developed a sufficient number of cell lines. Third, government grants could be given to groups to finance their medical research, "thus freeing their private money to pay for stem cell work."

A fourth option, pushed mostly be conservatives, would be to maintain the ban on ES cell research and increase the funding of adult stem cell research. However, each compromise option is unable to galvanize the support of both of the opposing interest groups; there is no compromise that will be both pro-life and pro-embryo stem cell research.

Congress has also inquired into the funding of ES cell research. Presently, Congress has yet to override the Dickey amendment, its contribution to the ES cell debate. One bill would continue the Dickey amendment heritage, increasing funding for only a few specific types of qualifying human stem cells. Some of the proposed bills and resolutions would nullify the Dickey amendment and allow for some version of federal funding. Congress, like the Bush administration, has a number of proposals but no solution to the ES cell debate.

Representative Smith, (R-NJ), introduced the Responsible Stem Cell Research Act of 2001, on June 7, 2001. The legislation was introduced to provide for a National Stem Cell Donor Bank for qualifying human stem cells. Those stem cells which would qualify are those "obtained from human placentas, umbilical cord blood, organs, or tissues of a living or deceased human being who has been born, or organs or tissues of unborn human offspring who died of a natural causes." Stem cells derived from embryos would not be covered under this bill and would not receive federal funding.

The opposing legislation is being sponsored in the House by Representative McDermott (D-WA) and in the Senate by Senator Specter (R-PA). The Stem Cell Research Act of 2001 seeks to provide federal funding for "human embryonic stem cell generation and research." There is no mention of providing funds for those stem cells covered under Representative Smith's Act. In order to receive funding for research on human ES cells, researchers must acquire the embryos from in vitro fertilization clinics where: "1) prior to the consideration of embryo donation and through consultation with the progenitors, it is determined that the embryos will never be implanted in a woman and would otherwise be discarded, [and] 2) the embryos are donated with the written informed consent of the progenitors." Furthermore, the research must not result in the creation of human embryos nor in the cloning of a human being. Those Congressional bills which support federal funding for ES cells limit the funding to those stem cells: 1) which would otherwise be discarded and 2) are only used for research purposes which are devoid of cloning.

Part II – Should the government fund embryonic stem [ES] cell research?
With an understanding of the science and politics surrounding the ES cell debate we must now ask ourselves if federal funding of ES research is a desirable public policy. We will initially examine those arguments in favor of ES cell research; it will become clear that such arguments are neither accurate nor compelling. We will also investigate the claims of the opponents of stem cell research, claims that such research is illegal, unnecessary, and unethical. A balancing of the competing interests will demonstrate a failure on the part of those supporting ES cell research to take into account the humanity of the embryo.

A. In support of federal funded embryonic stem [ES] cell research
Supporters of federal funding for ES cell research have three main arguments to defend their position. Initially, proponents demonstrate the scientific possibilities of ES cell research. Secondly, advocates point to the federal regulations that will accompany federal money, regulations that presently do not exist because all ES cell research is carried out with private funds. Most importantly, they seek to prove that the embryo from which the stem cells are harvested is not a person and thus there is no need to balance the death of a human life versus the benefits of stem cell research. Such an argument strengthens the final reason for funding ES research, an appeal to utilitarianism: if the embryos are going to be discarded anyway, they might as well be destroyed for the benefit of others. After looking at each of these arguments, it will become clear that if they held true, they would be overpowering.

I. Promise of ES Cells
It wasn't until a few years ago that the use of ES cells for medical research became a strong desire of the scientific community. In 1998, researchers, lead by University of Wisconsin developmental biologist James A. Thomson, isolated and maintained ES cells outside the womb, or in vitro. The researchers succeeded in stopping human ES cells from differentiating and instead kept them growing in lab dishes, thereby maintaining their pluripotency. Other groups, such as the Geron Corporation, are now in the process of figuring out how to turn these pluripotent stem cells into different types of human cells; as of July 9th, 2001, they could turn the stem cells into 110 types of differentiated cells. The hope is one day to be able to make infinite quantities of all cellular tissue in the body. If the scientific community succeeds in this goal then the former director of the NIH, Dr. Harold Varmus, would be correct in stating that "[stem cell] research has the potential to revolutionize the practice of medicine and the quality and length of life."
It is the ability of ES cells to grow outside the womb which excites the scientific community. Sen. Hatch, while arguing for funding for ES research, cites a portion of the NIH stem cell report which states that "Human embryonic stem cells can be generated in abundant quantities in the laboratory and can be grown (allowed to proliferate) in their undifferentiated (or unspecified state) for many generations." Thus, in addition to the ability to use these blank slates to create 110 types of differentiated cells, scientists are now able to grow numerous amounts of these ES cells for research purposes. "Because [ES] cells appear capable of indefinite self-renewal and differentiating into all adult cell types, this research has tremendous potential to provide new, important cell-based therapies."

II. Federal Funds and Federal Regulation
The scientific potential of ES research is possible because of lack of legislation outlawing such scientific work. Thus, it is argued by proponents of federal funding for ES research that such funding is necessary to bring federal regulation to such research.

In a recent TIME article, Charles Krauthammer, a supporter of ES research, discussed his fears of ES research without federal regulation. Krauthammer's fears are based on the decision by certain members of the scientific community to create human embryos for the sole purpose of destruction and research. On July 11, 2001, the Jones Institute for Reproductive Medicine, in Norfolk, VA, admitted that it had taken volunteered sperm and eggs, created a human embryo, and then destroyed it; the Jones Institute wanted ES cells. Most frightening was the response by the scientific community to this horrendous and deadly experiment. John Gearhart, a Johns Hopkins University researcher and "original stem cell pioneer", was quoted in the New York Times as saying that "he was ‘perplexed' by [the] development because [he] ‘didn't think it's necessary'". Dr. Michael Soules of the American Society for Reproductive Medicine (the only organization which presently is placing restrictions on the use of frozen embryos for research purposes) "saw nothing wrong with the procedure, except the ‘timing'". The ethical consideration of using a human as means to achieve a goal, rather then an end, in and of itself, was not mentioned by the leaders of the scientific community. Rather, they saw the creation of an embryo for research purposes as an unwise move for their arguments. In the minds of some scientists creating embryos is only bad if it politically undermines the call for federal funding.

In addition to using donated sperm and eggs to create embryos, a laboratory in Worcester, Mass., Advanced Cell Technology, is attempting to "grow cloned embryos to produce stem cells." If Advanced Cell Technology, Inc., is able to create an embryo through the process of cloning, it is only a matter of time before the procedure will be used to produce an adult human clone; all that is required is a cloned embryo, a willing womb, or womb-like environment, and time (it took 270 tries to succeed in giving birth to a cloned sheep).

The scientific research performed by the Jones Institute and Advanced Cell Technology, Inc., is not illegal. Some states have passed laws against the destruction of embryos, or the use of cloning techniques; however, there is no federal law governing these practices. It is argued that such unethical research is "indicative of the problems [that the U.S.] will continue to encounter if [the U.S. doesn't] allow federal funding with strict research guidelines for ES cell research." The regulations which are sought include laws 1) banning human cloning, 2) banning the creation of embryos solely for harvesting/research, and 3) permitting harvesting of ES cells only from embryos that would otherwise be discarded. Faced with the fear of scientists creating embryos solely for research purposes, public policy experts advocate federal funding of ES research, thereby bringing federal regulation into the ES arena.

III. The Embryo is not a person
Embryos, or "microscopic clumps of cells," have been described as anything but a person. The young embryo has also been contrasted with a goldfish; "a goldfish resembles a human being more then an embryo does." Also, brain-dead bodies and embryos have been considered the same, as non-persons. In the same article, embryos are compared to any other cell in the human body. Lastly, embryos are not considered live persons because they cannot live outside the womb.

The argument that goldfish are more human than an embryo and the comparison of brain-dead individuals to embryos is directly dependent upon a belief that personhood is determined through the actions of the mind. "A goldfish resembles a human being more then an embryo does" because "an embryo feels nothing, thinks nothing, cannot suffer, [and] is not aware of its own existence." A goldfish, by using its limited mind, is defined as more "human" than an embryo, whose mind has yet to develop from its stem cells. Presently science may define someone as being dead, even if they have a beating heart and are able to breath; such persons are considered brain dead; their brain no longer functions. In other words, life is defined by the ability of the brain to work: no working brain, no person. Without a mind, an embryo is not a person.

It is argued by Australian bioethicist Julian Savulsecu that "If all our cells could be persons, then we cannot appeal to the fact that an embryo could be a person to justify the special treatment we give it." This statement is based upon a belief that scientists will be able to create human beings through cloning. The cytoplasm of the egg contains all the chemicals, or DNA recipes, necessary to turn the embryo into an adult human being. Thus, if and when the cytoplasm of the egg is understood, researchers will have the ability to take any human cell, apply the specific recipe of DNA, wait nine months, and give birth to a human child. If this is possible, then how can an embryo be considered more of a person then a human skin cell; both have the possibility of becoming a live human being.

Supporters of ES research have been quoted as saying that "human life beings in the mother's womb, not in a petri dish, not in a refrigerator" and "if you have a stem cell in a petri dish, and you keep it there for 50 years, you'll end up with a stem cell in a petri dish … and until you place that in a woman, you are not going to create life." In other words, whether an embryo is a person depends on its location. An embryo inside a mother's womb has the potential to grow into a fully developed human being. A frozen embryo, sitting in a cryogenic chamber in a fertility clinic, does not have the potential to grow into a fully developed human being. In arguments against abortion, pro-lifers point to the obvious fact that "in the absence of abortion, [the] embryos or fetuses would have become full-grown people." However, ES research does not prevent births that would otherwise have occurred.

IV. Utilitarianism – the embryos will die anyway
Senator Hatch argues that surplus IVF embryos "are going to be thrown away. They are going to be discarded. They're going to be killed, if you will. Why can't we take the pluripotent cells from them and utilize them for the benefits of mankind?" Other supporters of ES research, like Senator Hatch, are also "sympathetic to the utilitarian argument that one might as well derive some good from the embryo's extinction." As previously discussed, current guidelines in the fertility industry allow for the discarding of frozen embryos after a period of five years. And, if the frozen embryos are not persons, (if they cannot in their present location develop into full adults), then the balance is between the eventual destruction of non-persons and the present destruction of those same non-persons for the benefit of mankind. If a non-person is to die, it is certainly wise to utilize that death for the benefit of all.

A. In opposition to Embryonic Stem [ES] Cell Research
The arguments in favor of federal funding for ES cell research are not compelling. Such claims fail on three main counts. First, federal funding of ES cell research is currently illegal. Second, adult stem cell research makes ES cell research unnecessary. Third, and most important, ES cell research and the requisite destruction of an embryo are unethical. It is ethically wrong for the federal government to condone and/or support ES cell research.

I. ES cell research is illegal

The funding of ES cell research by the federal government is "illegal because it violates an appropriations rider (the Dickey amendment) passed every year since 1995 by Congress." The rider states that no government funds may used to support "research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that" already allowed by federal law. The government is presently not allowed to fund any research which would kill an embryo.

There is an argument advanced by the former General Counsel of HHS that funding ES cell research is permitted because the government will not be funding the destruction of the embryo; as long as no money goes directly to embryo killing, the government may fund ES research. Such an argument fails to account for the intent of the legislators who passed the law; they intended that there be no killing of embryos, not that the government would ask someone else to perform the killing and then provide them funds for research on the remains of the dead. The intent of the legislators may be gleaned from the facts surrounding past federal funding of ES cell research; no federal funds have ever been used for such research. The failure to provide federal funds for any research project demonstrates that the Clinton administration initially recognized the rider as outlawing such an action.

Arguing that federal funding is illegal is powerful only as long as the Dickey amendment remains as federal law. Presently, fifty-nine Senators support the federal funding of ES cell research, and, therefore the legality argument is in some doubt, as to its future purchase. Thus, it is necessary to seek alternative arguments against federal funding.

II. ES cell research funding is unnecessary
Federal funding of ES cell research is not necessary for the scientific community to realize benefits from stem cell research. Such funding is not required because of the opportunities presented by adult stem cell research. Also, current research with ES cell research has proven disappointing. Funding of adult stem cell research will provide the benefits of stem cell research without the ethical dilemmas.

"Adult stem cells have been located in numerous cell and tissue types and can be transformed into virtually all cell types." The strongest argument for ES cell research has been the plasticity of the ES cells, specifically their ability to differentiate into all human cell types. Contrasted with this ES cell advantage, adult stem cells have been located in many human cell types including: brain, muscle, retina, pancreas, bone marrow and peripheral blood, cornea, blood vessels, fat, dental pulp, spermatogonia, and placenta. Adult stem cells have also been located in animal skin, liver and mammary gland cell types; and identification of these stem cells in humans is anticipated. Beyond the identification of such a large number of adult stem cells is the fact that a number of these adult stem cells "exhibit the ability to transform from one tissue type into many others." For example, adult stem cells from fat, of which we all have a fair amount, have been changed into cartilage, muscle, and bone. Scientists have yet 1) to discover all of the stem cells within the adult human body or 2) to determine the different cell types into which those stem cells may be transformed. Arguing that ES cells are the only means by which researchers may create all the cell types of the human body is a premature claim.

Adult stem cells, contrary to current claims by supporters of ES cell research, have the ability to be reproduced in such a manner as to create a "virtually limitless" supply. One study, in March of 2000, identified the required conditions to create a large scale expansion of adult stem cells in a culture, an expansion of billion-fold in a few weeks. And in another study, researchers "confirmed the ability to rapidly and significantly expand the numbers of adult stem cells in culture, so that sufficient numbers of a variety of adult stem cells [could] be produced for clinical applications." Researchers are beginning to discover the ways to create limitless supplies of adult stem cells.

Lastly, of adult stem cells and ES cells, only adult stem cells are currently being applied in clinical trials to the benefit of humans. "The biomedical potential of ES cells remains entirely speculative, because such cells have never been successfully used in clinical applications with human patients." Adult stem cells are currently being used in treatment for various types of cancer, auto-immune disease, stroke, cartilage and bones diseases and regenerating corneas. Researchers are currently utilizing adult stem cells for the same treatments others hope ES cells may someday provide.

ES cell research is presently wrought with disappointment. A recent study on cloning demonstrated that ES cells are genetically unstable, and thus makes clinical applications of ES cells complicated. With unstable ES cells, the production of an all-purpose cell line (a collection of stem cells for research purposes) is replaced by the establishment of hundreds of stem cell lines. Furthermore, cell lines would eventually need to be replaced as they became unstable. In order to continue with ES cell research, many more embryos will need to be destroyed then previously thought.

The unique ability of ES cells to differentiate into each kind of human cell and tissue is also proving to be the downfall of ES cell research. The fact that each individual ES cell has the capacity to turn into any human cell is a disadvantage for transplantation into living bodies. Recent studies have shown that ES cells injected into the body remained in "a disorganized cluster and the brain cells near them began to die." Such studies have lead to claims that "the emerging truth in the lab is that pluripotent stem cell are hard to rein in. The potential that they would explode into a cancerous mass after a stem cell transplant might turn out to be the Pandora's box of stem cell research."
In comparison to the problems of ES cells, adult stem cells are the safe alternative. Adult stem cells, unlike ES cells, naturally appear in the adult human body, where they pursue the task of repairing and regenerating human tissue; ES cells are not designed (assuming one believes that there is Designer of the human body) for such tasks. When adult stem cells reach a particular destroyed tissue, they produce only that tissue for which they receive signals. Utilizing the natural tendency of adult stem cells to meet the needs of the human body is a wiser course of action then attempting to control ES cells, cells which are alien to the adult human body and which have a tendency to form tumors, in an "effort to turn back into the complete embryo".

In September 1999, the National Bioethics Advisory Commission issued the "'Ethical Issues in Human Stem Cell Research' which concluded: In our judgement, the derivation of stem cells from embryos remaining following infertility treatments is justifiable only if no less morally problematic alternatives are available for advancing the research." We have seen that adult stem cells are meeting the same scientific qualities of ES cells. Adult stem cells presently hold out the possibility of producing all cell types, being created in limitless numbers, and continuing to provide medical benefits. Adult stem cells are proving to meet the unique characteristics of ES cells, in addition to their proven history of medical benefits to human patients, something ES cells have yet to accomplish. In fact, scientific research with ES cells has displayed the inherent risks of placing foreign cells into the adult bodies; ES cells are hard to control and manipulate and are not created for the tasks which scientists intend to pursue. Thus, if adult stem cell research proves to be less morally problematic then deriving ES cells, it must be pursued.

III. The use of ES cells is unethical
In order to obtain or derive ES cells, scientists must take a developing human embryo, puncture the cell wall, and extricate the inner cells from the rest of the embryo. What's left of the embryo is then tossed in the trash. Such an action is not pro-life, for there is a killing. The derivation of ES cells is the killing of a person. The killing of one innocent person for the medical benefit of others is ethically wrong.

A. Embryo Personhood
Fertilization is the creation of human being and it is at the point of fertilization that a person is created. Presently, 37 states and the District of Columbia recognize by statute, resolution, or court decision that "fertilization or conception initiates the life of a human being." The location of an embryo does not determine whether it is a person. A goldfish is not more of person then an embryo because the embryo possesses all the DNA of grown adult. The inability of an embryo to think does not make it a non-person. Viability alone does not determine personhood. Even if cloning does become successful, the initial act of procreation will create a person.

It is argued that an embryo is not a person because it is not in the womb. Thus, whether or not an embryo is a person depends upon its location. Such an argument is patently false. By this reasoning, if the embryo is removed from its frozen location and placed in the womb, it becomes a person. However, what if the embryo is taken out of the womb, and placed in a petri dish? Is that embryo, which was once a person, now no longer a person, just because it has left the womb? Of course pro-life, pro-ES cell research senators, pro-pros, will argue that once the embryo became a person, you can't remove its personhood; once it becomes a person, its location doesn't matter. It appears that the location-based argument may only be applied when we don't have a person; once we have a person, whose personhood was determined by their location, then their personhood can no longer be determined by their location.

Such an argument by pro-pros is inconsistent. The pro-pros argue that fertilization does not convey personhood, but location does. So does changing the embryos location change its status? Moving an unfertilized egg from the womb to the petri dish during IVF is not challenged by these pro-pros, even though the egg is located in the womb, the determiner of personhood. But if the egg is fertilized and removed from the womb, then the pro-pros would argue that you have removed a person from the womb. The only difference between the two eggs is their fertilization. Thus, the pro-pros eventual definition of personhood does rely on fertilization, and not location.

Let's now return to the argument raised by supporters of ES cell research that was characterized as "the goldfish is more human than an embryo" attack. Such an argument must be challenged on two grounds. First, we will ask whether other "things" which have been defined as persons should be no longer considered persons because their minds fail to work. Second, we must recognize that an embryo is nothing more than a young human, something a goldfish is not, nor ever will be.

Is the ability to feel pain, think rationally, or be self-conscious the definition which we would use to define a human person? An embryo, as far as we know can not do any of these things. Consider the Alzheimer's patient, one of the intended beneficiaries of ES cell research. Such a patient may lose the ability to think rationally or be self-conscious. Would they then be considered non-persons? And if so, why would we want to destroy human embryos for the benefit of such non-persons? If we are to consider Alzheimer patients who have lost their ability to reason, to use their mind, human persons, then the mind must not be the definer of personhood. Therefore, the inability of embryos to think must not be used to define them as non-persons.

What is it that makes a human being a human? "Scientists would say a human is defined by its DNA [whereas] stem-cell research enthusiasts would say we are defined by our DNA and our stage of development." Such ES cell advocates would argue that since a blastocyst is an unformed, 5 day old, collection of DNA, it can not be a person. "But it remains a fact – indeed one of the marvels of creation – that the embryo contains exactly the same amount of genetic information as you or I do." The only difference between the blastocyst and the fully developed adult human is degree, such as age, weight, height, etc. The embryo has all the DNA that is necessary to determine its fully developed human qualities; the DNA of an adult when it was 5 days old is the same as the DNA that is in that adult now. The goldfish on the other hand does not have any DNA which will define it as a human. The human embryo is a person, and the goldfish is not.

"Viability determines personhood" is another approach utilized by those in favor of ES cell research. The reason that the location in a petri dish does not grant an embryo personhood status under the "location-based" determination is not because the dish isn't a womb. Rather, it is because the embryo is not viable in that location; the embryo is unable to live on its own. Those who would argue that viability determines personhood would say that if the embryo can not live on its own, then it should not be considered a person. But if personhood is determined by viability, then "why shouldn't the physically incapacitated or the very old be consigned to medical experimentation? Why not those who are in comas or on life support?" "If they're going to die anyway and have no ability to fend for themselves, what's the point of wasting their bodies when they could yield valuable medical insights." We presently do not harvest the parts of comatose patients because there is an understanding that they are persons, even though they are not viable. Such should be the same for embryos.

Previously, we examined the statement: "If all our cells could be persons, then we cannot appeal to the fact that an embryo could be a person to justify the special treatment we give it." This statement by Julian Savulsecu is based on a belief that someday cloning will make it possible to turn each one of our cells into a unique person. As for our current scientific prowess, we can not currently clone humans from any cells. Mr. Savulsecu's statement assumes a scientific difficulty as being achieved and then asks how we will distinguish between those who have the potential to become his hypothetical "x" and those that already have. It is akin to saying that when humans can fly, what will we call young humans that have yet to develop their flying abilities. Even though his statement is fanciful, because cloning may eventually occur, it is important to address the ethical issue of "when does life begin for the clone".
Just because we may have the ability to turn a skin cell into a human does not mean that our understanding of sexual reproduction will change. Life, under sexual reproduction, will continue to begin at fertilization; the blastocyst will still have all the necessary DNA to achieve a fully developed human.

Where the new discussion will occur is under asexual reproduction or cloning; when does life begin if there is no fertilization. To maintain consistency in our original procreative definition of the beginning of human life, life should be defined as beginning at the initial stimulation of the cloning process.
An embryo is different then a skin cell, even after cloning becomes possible. The reason is the level of development. A skin cell is engaged in its current task of protecting a human body. However, an embryo is not a part of any other human but rather is its own distinct individual, developing into a full adult. Thus, even "if all our cells could be persons", the embryo, as a unique human, is distinct from stem cell and would be justified in receiving special treatment.
An embryo is a person, dependent upon neither location, self-consciousness, or viability for that determination. It is a unique human being.

B. Utilitarianism
"The IVF industry regularly produces more human embryos than it implants, leading to an exploding frozen living human population." Presently the way the in vitro fertilization clinics deal with frozen embryos is to store them for five years and then destroy them, unless the parents of the frozen embryo pay an additional storage fee. If the end of a frozen embryo is a wastebasket, then why can't the embryo be used for the benefit of mankind while it is being killed? The reason utilitarianism is a weak argument is because "two wrongs do not make a right."

The fact that frozen embryos are discarded is morally wrong. Frozen embryos, as we have discovered earlier are human beings; they are persons deserving protection of the state. Therefore, their killing, either by being discarded or harvested for their inner cell mass is wrong. Choosing the methods by which we kill an embryo does not justify that killing. A murderer who is deciding how to end his victim's life is not justified by choosing the removal of their organs as the method of killing, rather than a bullet to the brain. And the murderer is certainly not entitled to a profit from the sale of the deceased's organs. Should researchers and companies advocating ES cell research be entitled to profit from the killing of persons, solely because they would have been discarded anyway?

The government is not freed of the moral obligations of killing a person, by allowing someone else to do the harvesting of the stem cells. Revisiting Orin Hatch's utilitarian comments, it will become apparent that supporters of ES cell research find comfort in arguing that since somehow the embryos will be killed, it is justifiable for scientists to take the stem cells from the killed embryos. "They are going to be discarded. They're going to be killed, if you will. Why can't we take the pluripotent cells from them and utilize them for the best benefits of mankind?" Since someone else will do the killing, it's fine for the federal government to pay for the research on the human parts left over from the killing. However, such an argument was dismissed by the international community with the adoption of the Nuremberg Code. Formed after the atrocities of Nazi Germany, committed in the name of science, the Nuremberg Code forbids scientific research unless there is voluntary consent. Furthermore, "the code also prohibits experimentation that causes injury, disability, or a person's death", all of which are imposed upon the frozen embryo. ES cell research requires the killing of a person for the benefit of science, a concept which is decidedly contrary to international morality.

II. The Slippery Slope
"As promising as ES cell technology may seem, it does not solve the remaining problem of histocompatibility." Until scientists figure out how to deal with the patient's rejection of the ES stem cells, the research has "no realistic potential to be used for therapeutic purposes." ES stem cells may be grown in infinite numbers and for all cell types but until there is a way to introduce the stem cells into the human body, the ES cell research provides no benefit to the medical community or the suffering patients. And thus scientists are looking for unique ways to introduce ES cells into the human body; the most popular option is cloning.

"A cloned embryo has the same genetic codes as the donor, and thus transplantation of a pluripotent cell from this embryo into its original may avoid complications due to immune response rejection." The process of cloning would entail fusing the body cells from a patient with "an egg cell that has had its nuclear DNA removed." The embryo, genetically identical to the patient, would be allowed to develop into the blastocyst stage at which point it would be killed and its stem cells harvested. The patient's body would be less likely to reject the stem cells from an embryo which is genetically identical to itself.
The use of cloning presents two major problems. First, science is now creating human life for the sole purpose of its destruction. Secondly, it places science on the path to bringing a cloned embryo into adulthood.

Our pro-pros, as we have categorized pro-life Congressmen who are also pro-ES cell research have voiced their opposition to creating embryos for scientific research. They say that they are in favor of studies "as long as the embryos would be otherwise discarded." But ES cell research is of no value if it can't be applied to the patient; and cloning embryos for their ES cells is what will be required. Senator Brownback was correct when he stated that:

"In the future, people are going to say they want embryonic stem cells, but what they really want is to be able to clone you, to clone another individual, to take that DNA material from you, from me, from somebody in this room, destroy a young human embryo, put the DNA material in there, start this to reproducing for a while, kill that embryo, take the stem cells out, and work with those because they are exact copes of the DNA from us. We do not want to open this door of going the route of cloning, and that is where this is leading."

This statement was confirmed by the testimony of the president of Geron Corporation, the nation's leading for-profit group promoting ES cell research; "allowing the special creation of human embryos by cloning will be essential to the future of ES cell research." ES cell research, to be effective for therapeutic purposes, must necessarily involve the creation of embryos solely for their destruction.

And what are the possibilities if therapeutic cloning, cloning for the purposes of creating genetically identical ES cells, was allowed? Scientists argue that cloned embryos would not be allowed to live and that all the problems of cloned adults roaming the earth would not be realized. But this requires the government to sponsor the killing of embryos, persons, just because the government does not want them to live. Furthermore, the funding of cloning would move scientific research in that direction, the exact reason for the calls for federal funding of ES cell research. With research pursuing cloning, the techniques for bringing a cloned embryo to full adulthood will be considered and possibly achieved. The end result of cloning, a process which took 270 tries for one sheep and that is bound to prove more difficult in such a complex creature as man, is to be avoided at all cost.

III. Federal Funding is not necessary for Regulation
There are many ways for Congress to regulate ES cell research without providing federal funding, and thereby condoning, the research. Congress can simply outlaw those scientific practices which it finds to be contrary to public policy. Relying upon the Commerce clause, Congress has the power to regulate any activity that affects interstate commerce. In 1995, the Supreme Court found that Congress has the power to regulate things or persons within interstate commerce. Proponents of ES cell research argue that a frozen embryo is not a person; but they can not also argue that a frozen embryo is not a thing. The freezing of embryos and the extraction of their stem cells is commerce; there is money required for both processes. Thus, Congress has the constitutional authority to regulate all aspects of ES cell research without ever providing federal funding.

To argue that Congress must provide federal funds in order to protect against abuses of ES cell research is an argument which fails to recognize the vast power Congress has at its disposal. If Congress does not want there to be the creation of embryos for scientific purposes or the use of cloning techniques to create embryos genetically identical to the patient, Congress need only outlaw the practices; it does not need to fund the procedures.

Part III - What's to be done with the frozen embryos?
In 1984, John Kentrel, a Loyola University law student, pursued an independent study on the puzzle of what to do with two frozen embryos left behind in an Austrailian fertility clinic after their parents had died in a plane crash. His research on the topic lead him to draft a law which was adopted by the Louisiana legislature in 1986. The Civil Code of Louisiana recognizes human embryos as "juridical persons"; an "in vitro fertilized human ovum is a biological human being which is no the property of the physician which acts as an agent of fertilization, or the facility which employs him or the donors of the sperm and ovum [the parents]." Furthermore, Louisiana law states that "the use of a human ovum fertilized in vitro is solely for the support and contribution of the complete development of human in utero implantation. No in vitro fertilized human ovum will be farmed or cultured solely for research purposes." Lastly, "a viable in vitro fertilized human ovum is a juridical person which shall not be intentionally destroyed." Under Louisiana law, an embryo is a person who cannot be used for research purposes and has a legal right to life.

Presently, there are 188,000 frozen human embryos frozen and stored in fertility clinics. Not every state was as forward thinking as Louisiana and therefore most of those embryos are destined to five years of freezing and then destruction. The argument that research should be allowed on otherwise soon-to-be-discarded human embryos exists solely because state legislatures failed to act to protect human life. Yes, society could harvest the ES cells from these embryos, but such an action is not pro-life. The pro-life option would be to allow states to correct their oversight and pass laws protecting the youngest of human life. With 6.5 to 10 million infertile married couples in America who are seeking to raise children, finding wombs for our frozen youth will not prove to be a difficult task.

Part IV - Conclusion
In the final analysis, it is illegal, unnecessary, and unethical to support federal funding of ES cell research. Only the Responsible Stem Cell Research Act of 2001, as introduced by Rep. Smith of NJ, mandates that federal dollars not be used in the killing of an innocent human life. The current interpretation of the Dickey Amendment, allowing federal funds to cover research with ES cells as long as the federal dollars are not used to destroy the embryo, is a weak and unethical attempt at skirting the law; we, as a society, are just as guilty of committing murder whether we pay for the killing or provide a monetary incentive for the killing to take place. Cloning is undesirable and is currently in the process of being outlawed in the United States. Without cloning, ES cell research is limited to theoretical applications; a patient's immune system will reject the foreign objects. Adult stem cell research is a legal, ethical, and more effective alternative to ES cell research. The morality of society must determine the future of science and not the opposite.

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