der Biowissenschaften und ihrer Technologien
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| BioSkop – Forum zur Beobachtung
der Biowissenschaften und ihrer Technologien |
4.1 Technologies
4.2 Genesis of the stem cell debate
4.4. Stem Cell Patents: Institutions and Companies
Recent debates in the USA about human cloning and embryonic stem cells show that the two fields are closely interrelated in the development of techniques and legislation. The debate has two compounds. On the one hand, it is a discussion about the benefits of stem cells to cure diseases and about the risks of present techniques of cloning. On the other hand, it touches on the deeper ethical and social values of U.S. society. It is important to understand that several of the arguments can be traced back to past and ongoing confrontations around reproductive rights. Partisanship by and large occurs along the ‘pro abortion’ versus ‘pro life’ fault line. This has made it difficult to discuss technologies using human embryos in light of their own importance and their implications for the intrinsic value of human life. While this has hampered coalitions against such techniques, embryonic stem cell researchers now count on the support of some of those individuals and organizations that have traditionally opposed the use of embryos for investigations. This new coalition was instrumental in the compromise on public funding for embryonic stem cell research by president George W. Bush in August 2001. Bush’s decision will provide administrative predictability for research rather than limitations. It is also an expression of U.S. technology policy, which aims to regulate techniques by the allocation of public resources rather than by restrictive laws. At the same time, despite the fact that there is a broad societal agreement in the USA not to clone human beings, it is still not prohibited. Human cloning is not allowed using federal resources, but there is no legislation to make the private sector accountable. Pending anti-cloning legislation is put under pressure not to interfere with progress in embryonic stem cell research. Yet the extension of embryonic stem cell research will also increase the knowledge instrumental to cloning. The combination of market forces and scientific expertise available in the USA, together with the absence of regulation, may ultimately lead to a situation in which the knowledge for cloning humans will be available and, eventually, applied.
This report is dedicated to the ongoing debate in the USA regarding human cloning and stem cell research. Both issues have gained public attention and especially the debate regarding stem cells has proven to be a first test case for the new administration under president George W. Bush. This report will deal with scientific and technological aspects only where necessary (for an explanation of terms and techniques see the glossary). Instead, to better understand present coalitions and confrontations, the developments of certain interest groups and their arguments will be put into a broad perspective.
The report presents the opinion of some of the most important actors in the debate, such as the National Bioethics Advisory Committee (NBIA), research institutions, industry, feminist and disabilities’ rights groups, and religious groups. The present state of legislation will be discussed, and an outlook on the future will be given. The debate in the USA will be analyzed in light of the following aspects:
The Roe v. Wade decision granted women in their first trimester of pregnancy the right to choose whether to keep or terminate the pregnancy based on the concept of personal liberty as guaranteed by the Constitution. Abortion as a matter of individual privacy hence became compatible with the liberal tradition of separating the personal from the political.1 The ruling paved the way for later decisions regarding reproductive rights and the technologies used to exert such rights. American women could make private choices, however, access to the services was also privatized. In 1980 the Supreme Court upheld a Congress ban on the use of Medicaid funding for abortions; such funding was allowed only when the life of the pregnant woman was at risk.2 And in 1991 the Supreme Court confirmed, "The government has no constitutional duty to subsidize an activity merely because [it] is constitutionally protected."3 Consequently, the provision of abortion and other reproductive services was regulated by market forces.
From the beginning on the Supreme Court decision has been attacked by a coalition of pro-life forces, such as the National Right to Life Committee and religious groups, especially the Catholic Church. For them, life starts with conception and abortion is a morally unacceptable act of terminating life. While Roe v. Wade has never been reversed, it was successively eroded by state legislation. Across the country, between 1989 and 1992, over 700 state bills restricted women’s access to abortion were introduced. During the same period, violence against abortion clinics escalated, and some abortion practitioners were even killed by militant anti-abortion advocates.4
According to the National Abortion Rights Action League (NARAL), women’s reproductive rights today are more restricted than they were in 1973 when the Supreme Court handed down Roe v. Wade. As their data show, abortion would be illegal in 11 states if Roe v. Wade were overturned. Only six states and the District of Columbia are fully pro-choice.5
In most states access to abortion services is restricted through mandated waiting periods, denying use of public facilities except to save a woman’s life, restricting access to minors, and imposing informed-consent requirements, public-funding bans, and post-viability prohibitions.
Pro-life groups supported the last three Republican presidents and expected to further their agenda by the election of George W. Bush in December 2000. Bush declared not to touch the Supreme Court ruling on abortion; however, one of his first acts in office was to reinstate a ‘global gag rule’ that prevents international groups that receive U.S. funding from providing abortion services. He is also expected to appoint anti-Roe Supreme Court justices that may revoke the 1973 ruling.
At the same time, the U.S. public has not considerably changed its opinion on this issue. The majority calls itself ‘pro-choice’, yet supports a number of restrictions on the legal right to an abortion.6
While the abortion issue has turned into a litmus test for any U.S. administration and continues to cause conflict, it is by no means the only reproductive rights issue that plays a role for the debate on stem cells and human cloning. Another important aspect is IVF. After the birth of Louise Brown in England in 1978, the first child conceived by IVF, an ethical advisory board concluded that a human embryo deserves "profound respect" as a form of developing human life, but not necessarily "the full legal and moral rights attributed to a person."7 Consequently, certain experiments involving IVF embryos could be ethically acceptable. As we will see later, this viewpoint reverberates in the current stem cell debate and is brought forth by those anti-abortionists who have recently discovered the medical benefits of embryonic stem cells.
Following the 1991 Supreme Court ruling that no right for funding can be inferred from constitutional permission, Assisted Reproductive Technologies (ARTs) are not supported by federal research funding. Unlike new drugs or medical procedures, which are reviewed and regulated by the United States Food and Drug Administration (FDA), IVF and other reproductive technology procedures are not similarly monitored. Consequently, there is a growing array of fertility clinics that compete commercially for patients. More than 600,000 Americans have tried reproductive technologies and one in six couples who are infertile. Couples seeking IVF spend between US$ 44,000 and US$ 200,000 to achieve a single pregnancy. This has turned the reproductive medicine into a US$ 2 billion-a-year industry.8
Last but not least, the debate on reproductive rights touches upon the limitations of private decision-making. Feminists have argued that it is morally legitimate for a woman to not want to give birth to a child that is likely to have a serious health problem. Since women already do the majority of care giving in societies, rearing a child with serious health problems can decisively add to a mother’s burden.9 While new genetic testing possibilities have not opened an avenue to new treatments of diseases, they foster a general climate that is not in favor of people with disabilities. Marsha Saxton, a disability rights and women’s health activist contends:
"There is a key difference between the goals of the reproductive rights movement and the disability rights movement regarding reproductive freedom: the reproductive rights movement emphasizes the right to have an abortion; the disability rights movement, the right not to have to have an abortion." 10
According to Saxton this, however, would imply break the taboo in the feminist movement about discussing the fetus. Yet this is normally not done because it might lead to an alignment with the ‘pro-life’ forces.
In February 1997, it was announced that for the first time a mammal, Dolly the sheep, had successfully been cloned by somatic nuclear cell transfer (SNCT). This technique for non-sexual, identical reproduction involved transplanting the genetic material of an adult sheep, apparently obtained from a differentiated somatic cell, into an egg from which the nucleus had been removed. President Bill Clinton took immediate action in two ways. First, by executive order he posed a moratorium on federal funding related to such attempts to clone human beings. While this move was as far as he could have gone without congressional action to arrest human-clone technology, it had no bearing on privately funded research. Second, Clinton requested the National Bioethics Advisory Commission (NBAC) to examine the ethical implications of these technologies for possible use of cloning human beings. The NBAC was chartered in 1995 and had given advice to the president until its mandate expired in October 2001. However, there is no formal institution to oversee and regulate research with human embryos in both the private and the public sector.
In June 1997, the NBAC concluded in its report ‘Cloning Human Beings’ 11 that, for the time being, it was morally unacceptable to create a child using these cloning techniques. Basically motivated by safety concerns, the report did not vow for an absolute ban. It recommended to continue the moratorium of federal funding in support of any such cloning attempts and requested private sector actors to voluntarily abide by the same restriction. It concluded furthermore that, if federal legislation were enacted, it should be for a specified time period and the issue be re-evaluated in the future light of scientific progress and public understanding. Most importantly, especially for the upcoming debate on stem cells, the commission suggested that future federal or state legislation to ban human cloning not impede the use of cloning techniques in medical research.
Dispute in Congress started with a more restrictive bill, which would have banned reproductive cloning as well as the creation of clonal embryos. It was introduced by Republican Senators Bond (MO), Frist (TN) and Lott (MI). However, the biotechnology industry lobbied heavily against this bill, which was ultimately rejected by the Senate. A less rigid bill to ban cloning was introduced to the Senate in February 1998 by Democratic Senators Feinstein (CA) and Kennedy (MA), yet no attempt was made to subsequently pass this bill and the USA remained without federal cloning legislation. Meanwhile five states – California, Louisiana, Michigan, Rhode Island, and Virginia –have passed legislation to prohibit human reproductive cloning. In all five state statutes, however, cloning research is not explicitly outlawed.
Concerns were fuelled again in January 2001, when Panos Zavos, a professor at the University of Kentucky, and Severino Antonioni, an Italian doctor known to help post-menopausal women become pregnant, announced they would try to clone human beings. In March 2001, a religious cult, the Raelians, claimed to have started efforts to clone a dead child. Yet as much as 90 percent of the U.S. population opposes human cloning. And strong majorities are against cloning to produce vital organs to save others (68 percent) or to help infertile parents to have children (76 percent).12
On July 31, 2001, the U.S. House of Representatives adopted a far-reaching bill on human cloning. Sponsored by the Republican Representative David Weldon (FL), ‘The Human Cloning Prohibition Act of 2001’ (H.R. 1644) covers not only reproductive cloning, but also the cloning of human embryos for medical research and ‘therapeutic cloning’. The same bill is now pending in the Senate where it was introduced by the Republican Senator Sam Brownback (KS). Given the outspoken pro-life position of Senator Brownback and the complicated strategies of policies surrounding this issue, it remains to be seen if the bill has a chance to pass the Democratic majority in the Senate (see also below).
If a federal ban on human cloning were finally adopted, there are several questions as to its constitutionality. One specific problem would be if researchers in pursuit of their right to scientific inquiry could successfully challenge a ban on human cloning. The First Amendment right to free speech also entails the right of scientific research.13 In 1972, the U.S. Supreme Court made the analogy that the function of academic research in providing information is much like that of the press.14 However, other court cases have specifically rejected the idea of a fundamental right of scientific inquiry. While one could think of many reasons why there should be a limit to the researchers’ freedom, here the issue at stake was medical research conducted on the unborn. 15
There is another important link between the constitutionality of cloning and the right to reproductive decisions: In the USA, the right to decide about whether to bear children is protected under the constitutional right to privacy16 and liberty17. Such reproductive decisions also encompass the right of an infertile couple to use medically assisting procedures, such as IVF or the use of donated embryos. Therefore some legal analysts have concluded that the constitutional right to make procreative decisions without government intrusion might also allow a couple to undergo reproductive cloning18. However, other legal analyses comes to the conclusion that cloning is not constitutional because the unprecedented step of creating a child with only one genetic parent would be a fundamental change in the way humans procreate.19
By definition, stem cells have in common the ability to self-replicate and to give rise to specialized cells and tissues that have specific functions, such as heart, brain, and bone cells. There are important differences, however, depending on where they are derived from:
Whatever the source of the stem cells, there are still a lot of unresolved problems before their therapeutic potential to treat Alzheimer’s, Parkinson’s disease or diabetes would come to fruition. For instance, fetal tissue transplants in the brains of some Parkinson’s patients have proven to deteriorate the conditions of some patients.20
As an alternative to embryonic cells there are laboratory studies underway using adult stem cells harvested from different types of tissues. One problem in dealing with adult stem cells is how to obtain enough cells. For this, ‘therapeutic cloning’ has been discussed: the creation of a new embryo that is genetically identical to the patient which could produce stem cells. This creates two sets of problems:
In the USA the history of embryonic and fetal research regulation has been a matter of federal funding decisions rather than of legal bans. Fetal research appeared on the U.S. policy agenda for the first time in the early 1970s, after some doubtful experiments with live fetuses had gained wide publicity. As a reaction, in 1975 federal laws were amended to regulate federally funded research on human subjects, including fetuses. The guidelines prohibited funding fetal research unless it directly benefited the mother or the unborn child. Yet the regulation was fraught with loopholes, because it allowed for research if the risk was ‘minimal’, meaning not bigger than in ordinary life or during routine physical examination. It furthermore did not tackle two issues that would become important in future decision making:
Most important for the subsequent stem cell debate was the recommendation of a Human Embryo Research Panel at the National Institutes of Health (NIH). In 1994, the panel recommended federal funding for a variety of experiments using human embryos, such as their intentional production for research purposes, and the destruction of embryos to derive stem cells. Yet the recommendation was rejected by president Clinton, who issued to limit funding of research to those embryos that were in abundance from IVF procedures. In 1995, research was further restricted when Congress decided to extend the prohibition of federal funding to any research in which embryos are harmed or destroyed. However, in late 1998, fuelled by scientific progress in privately funded research, proponents of federal funding reopened the issue.
In November 1998 researchers at the University of Wisconsin and Johns Hopkins University succeeded for the first time in creating pluripotent stem cell lines from embryos that were remaining from infertility treatment or from aborted fetuses. The NBAC was requested by President Clinton to come up with an analysis of the issue. Its report ‘Ethical Issues in Human Stem Cell Research’21 concluded that federal funding should be made available for stem cell research on aborted fetuses and from embryos that would otherwise be discarded. In this report the commission revisited the issue of reproductive cloning and found its moral considerations different from those related to research cloning. While for the former, issues pertain to the safety of the fetus and the mother and the potential impact on the concept of reproduction, the latter is generally related to the embryo research debate. Consequently, the commission reiterated the necessity of a moratorium for reproductive cloning, but not for research cloning. The commission acknowledged that the use of stem cells from cloned embryos may have therapeutic potential, because it could provide tissue for autologous cell replacement therapy. While the NBAC saw no justification for federal funding for these activities, it did not, however, propose a moratorium on such research in the private sector. 22
Yet guidelines for funding embryonic stem cell research that were developed by the NIH during the end of the Clinton administration in August 2000 did not go that far. While the guidelines on the one hand forbid federal funding for destructive research on human embryos, they nonetheless allowed researchers to obtain government support if the destructive step to gain cell material was carried out in a private institution.23 This somewhat awkward compromise only covers embryos derived from IVF. However, NIH funds may be used to derive cells from fetal tissue, be it provided from miscarriage or from abortion.
In spring 2001, the newly elected president George W. Bush delayed the implementation of the NIH guidelines and promised their review by summer. Under the new administration the influence of Christian religious groups has become more pronounced, as well as their plea for the protection of unborn life. However, not all of those who were in the past united in their rejection of abortion are now against stem cell research involving embryos. One faction, mostly Catholic, still rejects embryonic stem cell research due to pro-life arguments. Yet other influential anti-abortionists, such as the Health and Human Services (HHS) Secretary Tommy Thompson, or the Republican Senator Orrin Hatch (UT) find it ethically acceptable to balance the use of embryonic cells against the expected benefits of their use in medical research. Some of them share the view of the NBAC that an embryo deserves respectful treatment, but not the same respect as a fully developed person.
In the federal arena the conflict is about funding the use of embryos in stem cell research, not about its prohibition. However, there are laws in 22 states to govern such research and there are at least nine in which any experiment with human embryos is banned. Yet there is only one state, South Dakota, which explicitly forbids embryonic stem cell experiments.24
On August 9, 2001, president Bush announced a new ruling on the funding for stem cell research. Under this compromise, federal funds will be used only for research on one of 64 existing stem cell lines that had already been derived earlier:
No federal funds will be made available for:
To oversee the ramifications of the development, president Bush announced the creation of a new President’s Council on Bioethics, which will be headed by Leon Kass, a bioethicist from the University of Chicago.
Since all funding decisions must be adopted by Congress, it may try to alter this compromise. However, the president already announced that he would veto any legislation that would go beyond the parameters he had specified. Furthermore, both proponents and opponents of federal funding have filed lawsuits against this decision.
On August 27, 2001, the NIH published a list of 64 embryonic stem-cell lines, provided by 10 laboratories in the USA, Sweden, Australia, India and Israel. 25
After the president’s decision, public discussion shifted away from ethical considerations towards whether the guidelines adequately support the science. Next to the quality of the stem cells, their accessibility has become a contentious issue. One of the arguments in favor of publicly funding embryonic stem cell research is that it makes the process more transparent and its results publicly available. However, the stem cell issue proves to be an example for recent innovation models in which patents become the predominant bargaining chip and where researcher at universities and companies have similar attitudes toward the protection of innovation. While private companies have created one third of the cell lines, the most important patents in stem cell research are held by university researchers, which have entered into commercial agreements with biotechnology firms.
The University of Wisconsin holds a key position in this regard: In 1998, they derived five stem cell lines from embryos that had become superfluous in an IVF procedure. The Wisconsin Alumni Research Foundation (WARF), which handles the intellectual property on behalf of the researchers, received a U.S. patent (U.S. 6.200.806) which covers not only the already established ES cell lines but also the method for their production. In 1999, WARF created a private subsidiary, the WiCell Research Institute, to carry out research on human stem cells without conflicting with federal funding regulations.
It had been contended that this key patent might become an impediment for the entire research approach. However, under the Bayh-Dole Act of 1980, which gives universities ownership of patents developed using government funds, the government has the right to force compulsory licensing of the patent to others.26 To prevent this, on 5 September 2001, NIH and WiCell signed a memorandum of understanding to make available the cell lines for research.27
At the same time, WARF had already given an exclusive license to the biotechnology company Geron Corp. (CA), for the commercial exploitation of embryonic stem cells in cell-based treatments using heart, nerve, pancreas and other cells. Recently, WARF sued Geron to stop the company from using the licensed technologies for 12 other cell types.28 The company is already well positioned to play a leading role in the future commercialization of stem cells, in which cloning techniques are indispensable. To obtain the cloning technology, Geron in 1999 acquired Roslin Bio-Med, the commercial spin-off of the Scottish research institute that cloned Dolly the sheep. 29
Other companies providing stem cells are the Singapore-registered corporation ES International, which operates with stem cells from the Monash University in Melbourne, Australia. As the NIH’s list of cell lines eligible for public funding proves, embryonic stem cell research has developed into a globalizing endeavor. While one aspect of the shape of the international landscape are intellectual property rights, the issue of finding international standards of regulation is virulent too. India, for instance, has a well-established network of private reproductive medicine facilities, and two Indian organizations provide stem cell cultures for the U.S. researchers. As one of the Indian researchers claims "[T]here are no religious, cultural, political or social barriers to this research India."30 This nurtures the suspicion that ethical dilemmas in one country might be circumvented by carrying out research in another one.
Not only does a majority of the general U.S. public oppose human cloning, so do various societal stakeholders. However, they differ considerably in their argumentation and especially in how far measures to prevent human cloning should go. The fault lines are not only between but also within religious belief systems, as well as for groups and individuals that argue from a secular perspective. There are generally three categories of positions on the issue of human cloning and the use of embryos:
In the USA the most consequent and outspoken rejection of any research using embryos is based on religious grounds. A significant number of Catholics, including present spokespersons for the American bishops,31 argue that human embryos must be equally protected as human persons and hence, not used for stem cell generation or any other kind of research.32 This view is shared by scholars of the Orthodox Greek Church. They hold that unborn life deserves the same protection as that which is already born. The process toward authentic human personhood begins with the zygote and it is unimportant whether it is created in vitro or in situ.33
In its testimony for the NBAC, Abdulazis Sachedina of the University of Virginia deduces the Islamic perspectives on research with human embryonic stem cells as dominated by issues related to ascertaining the moral-legal status of the fetus. The fetus is a moral and legal entity only at a later stage of its biological development (month 4). No specifying judgement is made for interventions before that time, except that it will only be in line with the Islamic belief if it is undertaken with the purpose of improving human health.34
The American Association of People with Disabilities (AAPD)35 is a disabilities’ rights organization that has explicitly opposed the cloning of humans. The focus of the disabilities rights movement in the USA has been in the tradition of civil rights movement. While pursuing equality by political and economic empowerment, biotechnologies and reproductive technologies as well as the fear of eugenics have played a comparatively lesser role.36 Contrary to many patients’ organizations, which are focused on finding cures for diseases, AAPD has not yet come up with a unanimous position on stem cell research. While some members are in favor of stem cell research, others think that resources would be spent more wisely on general health care.
The Council for Responsible Genetics (CRG), founded in 1983, is the oldest national non-governmental organization (NGO) engaged in the public debate about the development and introduction of new genetic technologies. The CRG called for a ban on human cloning,37 but also "the utilization of human eggs and embryos for experimental manipulations"38 including therapeutic cloning. While some CRG members favor a general ban on embryonic stem cell research, this position has presently not found a majority within the organization.
Also women’s health and reproductive rights representatives have called for a ban on reproductive cloning.39 While they support research to determine whether embryonic stem cells have therapeutic effects, it would not be necessary to clone human embryos for this purpose. Therefore they suggest a five-year-moratorium on cloning to create human embryos for research purposes, because it would otherwise be difficult to enforce a ban on the production of genetic duplicate humans.
Similarly, the Center for Genetics and Society, an NGO that is lobbying for a ban of human cloning and the inheritable genetic modification of human beings, argues for the use of embryos produced in IVF procedures. The organization supports a moratorium on research cloning on embryos. However, if problems with stem cells to create immune-compatible tissues could only be solved by embryo cloning, and if bans on reproductive cloning and inheritable genetic modification are in place, the moratorium on embryo cloning should be revisited.4023
An even stronger case for the use of embryos in stem cell research is made by the National Organization for Women (NOW): "Medical McCarthy-ism is blocking embryonic stem-cell and fetal-tissue research, dashing the hopes of those who suffer from diseases and conditions such as diabetes, Parkinson’s disease and spinal cord injuries."41
Support of advanced embryo research is also raised by religious denominations. In his testimony for the NBAC, Testimony of Rabbi Elliot N. Dorff holds that in Judaism "the fetus, during most of its gestational development, is seen as ‘the thigh of its mother’, and neither men nor women may amputate their thigh at will, because that would be injuring their bodies, which belong to God."42 Embryos created in a petri dish fall outside Jewish law, because they are not part of a woman and do not have the potential to grow into a human being. As a result, frozen embryos may be discarded or used for reasonable purposes and so may stem cells that are procured from them.
One of the most influential bodies claiming this position was the NBAC. In 1997, when it issued its report ‘Cloning Human Beings’ to president Clinton, it came to the conclusion that reproductive cloning should be banned temporarily under a moratorium for three to five years. In 2000, when the NBAC was requested to advise on the issue of embryonic stem cell research, this moratorium was reconfirmed. However, the NBAC did not extend the moratorium on research cloning, because of its expected medical benefits.
Although some researchers cautiously welcomed the compromise announced by George W. Bush, voices that emphasize the need for extended research dominate the U.S. biomedical research and industry community. In September 2001, the National Academy of Sciences issued a report in which it not only suggested the need for new embryonic stem cell lines, but also the necessity applying cloning techniques for producing embryonic tissue.43 The Biotechnology Industry Organization (BIO), together with 122 patient, research, and academic institutions, supported federal funding of stem cell research.44 However, BIO opposes human reproductive cloning and pleads for its voluntary moratorium, as instituted in 1997. At the same time, it supports ‘therapeutic cloning’ and the use of embryonic cells to improve scientific understanding, short of developing an entire human being.45
As one of the many patients’ organizations that follow the line of BIO, the Genetic Alliance,46 an organization of people living with genetic disorders, calls for an immediate halt to all efforts to clone human beings. However, they insist that creating a living human being through cloning is very distinct from cellular, tissue and organ cloning, which are seen to hold significant promise for generating treatments and cures for common and rare diseases. Therefore, they oppose the adoption of legislation that impedes such research, such as the ‘Human Cloning Prohibition Act of 2001’ that was adopted by the House of Representatives.47
Certain Protestant denominations, such as the United Church of Christ, do not regard embryos as persons, but as having a lesser though still important status. If federal guidelines were put into place for both the private and public sector, they would not oppose embryonic research including embryonic cloning.48
President Bush’s declaration in August 2001 provided legislative security for embryonic stem cell researchers by allowing them to file for federal funding, given the constraints discussed. In 2001, US$ 250 million was made available for stem cell research using cell material from non-embryonic sources, however, it is not yet disclosed how much money will be made available for projects on embryonic stem cells.
Next to the amount of support made available, the number of embryonic cell lines eligible for federal funding is a critical issue. After the publication of NIH’s list of 64 embryonic stem cell lines, some of the laboratories announced that they have yet to characterize their cell lines before making them available to the general research community. The Bush administration conceded that there are only 25 stem cell lines fully developed. It remains to be seen if the quality and quantity of these lines will be sufficient. U.S. stem cell researchers have already started to lobby for an extension to cover their scientific needs. 49
In the medium and long term, the consequence of the presidential decision may not be so much about the quality or numbers of present cell lines, but the fact that scientists cannot use federal money to study new ones that will be developed with private money. In this sense, Bush’s compromise poses a restriction to the situation under president Clinton, which would have allowed for such an approach. Since the private sector is free to develop cell lines from additional embryos that would otherwise be discarded by IVF, one arising question is whether this will lead to a shift of stem cell research from government- to privately-funded institutions.
Some voices from the biotechnology industry claim that, similar to the race between the genomics company Celera and the publicly funded Human Genome Project, the private sector will lead the way and public money may be wasted.50 This argument can be dismantled relatively easily: in genomics, it was public research that provided the scientific basis for Celera’s ambitious agenda to screen the human genome in only two years. Biotechnology stakeholders like BIO also see this interplay of public and private research as instrumental. Similar to the sequencing of the human genome, the competition may rather lead to increased efforts in the public sector and thereby growing pressure on the government to allow more stem-cell lines to be used in federally funded research.
Yet for the future of embryonic stem cell research, it is not only the decision about public funding that plays a role but also the legislation regarding cloning. If the Weldon bill, which passed the House of Representatives, became law, it would prohibit ‘therapeutic cloning’, which is heralded as one of the most promising aspects of embryonic stem cell usage. It would furthermore outlaw the creation of embryos for research purposes. Such activities were already announced by private companies: in July 2001, a private fertility clinic in Virginia announced that they had produced IVF embryos for use in stem cell research.51 One day later, Advanced Cell Technology, a biotechnology company in Massachusetts, claimed to have cloned embryo-like entities from which embryonic stem cells could be derived.52
However, the adoption of the Weldon bill, introduced to the Senate by Senator Brownback, will face an uphill struggle against the majority of Democrats. As a matter of political tactics it is inconceivable for many Democrats to rank files with an explicit ‘pro-lifer’. Furthermore, key Democrats such as Senator Edward M. Kennedy, Chairman of the Senate’s Committee on Health, Education, Labor and Pensions, are in favor of embryonic stem cell research and not likely to support a bill that would impede such investigations.
It is likely that a cloning bill, if ever adopted, will have to undergo modifications. When the House of Representatives voted for the Weldon bill, it struck down an alternative that would have allowed for embryonic cloning. The ‘Cloning Prohibition Act of 2001’ (HR 2172), introduced by Republican James Greenwood (PA) suggested a 10-year moratorium on reproductive cloning and only voluntary restrictions on research cloning. One conceivable compromise might be to pose a moratorium on research cloning, while the complete ban on reproductive cloning of the Weldon bill remains in place. 53 Yet this compromise would face opposition by researchers and institutions for which it might pose an impediment on immediate continuation of their embryonic stem cell research.
For the Bush administration’s future approach to ethical issues arising from biomedical research, it will be of importance that the NBAC longer exists (its mandate expired in October 2001). Past NBAC recommendations regarding human cloning and stem cell research argued more in favor of biomedical research than were ultimately implemented in federal regulation and funding by the Clinton administration. Bush announced the creation of a new President’s Council on Bioethics, which will be headed by the bioethicist Leon Kass. Kass was already instrumental in advising the embryonic stem cell funding decision and is known to be less favorable to biomedical research than the NBAC.
The current debate in the USA around embryonic stem cells and human cloning is both a discussion about very specific technological advancements and about general ethical values. Principles that are widely shared amongst the U.S. society, such as privacy, choice, and self-determination have various ramifications which make it hard to find a legislative common ground in accordance with an individual’s right to use certain techniques that might be in his or her personal interest.
Yet this is only one of the reasons why a broad societal consensus in the USA not to clone human beings might nevertheless be insufficient to stop such an endeavor from happening. The fear of cloned human beings appears to be the flipside of the enthusiasm regarding the beneficial potential of stem cell research. The former is fuelled by some rogue scientists and cults from which the scientific mainstream only too eagerly distances itself in its rational aim of treatments and cures for so far untreatable diseases. The question remains, however, whether the stem cell ticket might be overdrawn, as was the case with earlier biomedical breakthroughs. Both gene therapy and the sequencing of the human genome were hailed as scientific revolutions in the treatment of incurable diseases, yet reality has proven to be more complicated and sustainable results, if any, are scarce.
Nevertheless, it is realistic to conclude that scientific progress in the field of embryonic stem cells will also foster progress in other areas. Embryonic stem cells could be used to study early events in human development. This research will inevitably further knowledge on problems that have to be solved to make cloning of human beings feasible. Conversely, a ban on human cloning and the production of human embryos for research purposes will limit the progress in the field of stem cell investigations. Widespread support for stem cell research may therefore be one of the main reasons why rigid anti-cloning legislation will not pass the Senate. For the time being, in the USA there is no ban on human cloning and given the present priorities in U.S. politics after the September 11 attacks, not very likely to be reached in the near future.
The present legislative impasse opens another question: An outright ban on cloning would mean a paradigm shift in technology regulation. Ever since the introduction of gene splicing techniques and the moratorium to use them in the early 1970s, U.S. biotechnology policy regulation by and large functions through resource allocation of federal funding and voluntary compliance of researchers. Yet this leaves out the private sector and as we have seen in the development of embryonic stem cell techniques, progress in private sector research is used to justify new policy and funding guidelines for federal funding.
This loop of scientific progress, public and private funding is at the core of the much-envied U.S. model of biomedical innovation. Emphasizing his appreciation for this model, President Bush already announced that the NIH funding in 2002 will rise to an unprecedented US$ 23 billion.
The decision regarding embryonic stem cell funding therefore has to be read as a measure to provide administrative predictability for research rather than to limit it. Also in the future it could be that funding for certain approaches in biomedical research will lag behind the demands of some scientific and biotechnological actors. Their needs will have to be balanced with the government’s need for backing by religious voters. The most important long-term consequence of the stem cell compromise will nevertheless be that broader societal acceptance of techniques be achieved. By convincing many of those traditionally on the side of the protection of unborn life, new coalitions have been built from which the biomedical research sector will profit as a whole.
Forces that question the benefits of biomedical research and the use of embryos are still hampered in coalition building because of the entrenchment of those who oppose abortion and those who do not. Some of the most pronounced criticisms against embryonic stem cell research misuses the discontent about such techniques for its own agenda against reproductive rights. This is complicated by the fact that the dilemma about embryonic stem cells is partly a spin-off of IVF. Yet some women’s increased use of technological measures for reproductive rights is also a contentious issue amongst feminists and others who advocate a woman’s right to determine her pregnancy. Many of them agree with the use of embryos in research. For those who do not, but come from a secularized perspective that defends women’s reproductive rights, there are also arguments to be found for the intrinsic value of human life. While this may start as a matter of opposing the commodification of life, it could ultimately lead to a broader meaning of anthropological values. It may be a bridge to those who oppose the use of embryos from a perspective of their religious faith.
Such a broad coalition will be necessary to stem other stakeholders’ lobbying
for an extension of biomedical research in which the use of embryos as a commodity
is an important aspect. It will also be necessary for a coalition against human
cloning, which otherwise will be weakened by one extension of research following
another. In that case, the cloning of the first human being would only be a
matter of time. And given the scientific expertise and market forces amassed
in this country the first cloned human may very well be born in the USA.
Adult stem cell: An undifferentiated cell found in a differentiated tissue that can renew itself and differentiate into the specialized cell types of the tissue it is derived from. Although adult stem cells are often rare to identify and to culture, they have been found in tissues that develop from all three embryonic germ layers.
Autologous cell replacement therapy: Also called ‘therapeutic cloning’, and seen as a future approach to transplants: The nucleus of a somatic cell of the recipient would be transferred into an enucleated egg (see somatic nuclear cell transfer). Cultured in vitro to harvest ES cells, they should then differentiate into the desired cell and tissue type. Such a transplant could help avoid complications of immune rejection, because the cells would match exactly the immunological profile of the person who will receive the transplant.
Blastocyst: The stage of an embryo of 30 to 150 cells, before it implants in the uterine wall.
Ectoderm: The upper, outermost of the three primitive germ layers of the embryo, which later differentiates into nerves, brain, and skin.
Embryo: The developing organism from the time of fertilization until the end of the eighth week of gestation, when it becomes known as a fetus.
Embryonic stem (ES) cells: Undifferentiated cells from the embryo that have the potential to become a wide variety of specialized cell types. Human ES cells are derived from the inner cell mass of blastocysts. For this, embryos generated through in vitro fertilization are used.
Endoderm: Lower layer of a group of cells derived from the inner cell mass of the blastocyst; it later becomes the lungs and digestive organs.
Fetal stem cells: After about 8 to 10 weeks, when the embryo develops into a fetus, also the stem cells change. Fetal stem cells have adult, rather than embryonic characteristics.
Mesoderm: The middle germ layer of the embryo, which is the precursor to bone, muscle, and connective tissue.
Plasticity: The ability of stem cells from one adult tissue to generate the differentiated types of another tissue.
Pluripotent stem cell (PSC): Pluripotent stem cell that has the capability of developing cells of all germ layers (endoderm, ectoderm, and mesoderm) of the embryo.
Somatic nuclear cell transfer (SNCT): The transfer of a cell nucleus from a somatic cell into an egg from which the nucleus has been removed.
Somatic cells: Any cell other than a germ cell or germ cell precursor.
Therapeutic cloning: See Autologous cell replacement therapy
Totipotent: Having unlimited capabilities. Very early embryonic cells have the capacity to develop into all embryonic membranes and tissues, but also into tissues that support the development of the embryo, such as the placenta.
Zygote: A cell formed by the union of female and male germ cells (egg and sperm, respectively).
(Source: NIH (2001), Stem Cells: Scientific Progress and Future Research Directions. Bethesda, MD: NIH.)
American Association of People with Disabilities (AAPD): www.aapd.com
American Journal of Bioethics Online: http://ajobonline.com/
Biotechnology Industry Organization (BIO): www.bio.org
Boston Women’s Health Book Collective: www.ourbodiesourselves.org/
Council for Responsible Genetics: www.gene-watch.org/index.html
Genetic Alliance: www.geneticalliance.org
Global Lawyers and Physicians: www.glphr.org
National Bioethics Advisory Commission (NBAC): http://bioethics.georgetown.edu/nbac/
National Catholic Bioethics Center: www.ncbcenter.org
National Institutes of Health (NIH) Stem Cell Information: www.nih.gov/news/stemcell/index.htm
National Organization for Women (NOW): www.now.org
Volker Lehmann
European Media Tel: 1-212-764
2228
28 West 39th Street Fax:
1-212-764
2234
New York, NY 10018
E-mail:vlehmann@prodigy.net
URL:www.europeanmedia.de
1) Yet, instead of seeing abortion as a part of women’s right to privacy, the comparison with Canada reveals that there are also other approaches to the right to abortion, for instance to see it as a part of women’s right to health care. – back to the text
2) Henshaw, S. (1992), Induced abortion: A world overview. In: Henshaw, S. and Van Vort, J. (eds.). Abortion factbook: 1992 edition. New York: Allan Guttmacher Institute. – back to the text
3) Henshaw, S. and Van Vort, J. (1992, eds.), Abortion factbook: 1992 edition. New York: Allan Guttmacher Institute. – back to the text
4) Solinger, E. (1998, ed.), Abortion Wars: A Half Century Of Struggle. Berkeley: University of California Press. P. X. – back to the text
5) Greenberg, A. (2001), "Will choice be aborted?" The American Prospect; Fall. Supplement: Body Politics, A25-A28. – back to the text
6) According to Gallup data dating back to 1975, the number of Americans who would make abortion illegal in all circumstances has ranged between 12 percent and 19 percent, while the proportion who would impose some restrictions has fluctuated between 48 percent and 58 percent. There is no discernible pattern to this variation over time. – back to the text
7) See 44 Federal Register 35033-58 [June 18, 1979], p. 35056. – back to the text
8) "Genetics, reproduction, and the law" (1999), Trial: Law in the 21st Century. July. Interview with Lori B. Andrews. In: Reader Beyond Cloning Conference, September 21-22, 2001, Boston University. p. 77. – back to the text
9) See Purdy, L.M. (1996), Reproducing Persons: Issues in Feminist Bioethics. Ithaca, New York and London: Cornell University Press. Pp. 82-83. – back to the text
10) Saxton, M. (1998), Disability Rights and Selective Abortion. In: Abortion Wars. A Half Century of Struggle, 1950-2000. Solinger, E. (ed.). Berkeley, CA: University of California Press. P. 374. – back to the text
11) See http://bioethics.georgetown.edu/nbac/pubs/cloning1/cloning.pdf – back to the text
12) "The politics of gene wars: America’s next ethical war" (2001), The Economist, April 14, 21-24. – back to the text
13) Andrews, L.B. and Rosenow, L. (2001), Cloning Position Paper of the Institute for Science, Law and Technology. In: Reader Beyond Cloning Conference, September 21-22, 2001, Boston University. P. 82. – back to the text
14) Branzenburg v. Hayes, 408 U.S. 665, 705 (1972). – back to the text
15) See for example Margeret S. v. Treen, 597 F.Supp.636 (E.D. la. 1984). Quoted in Andrews, L.B. and Rosenow, L. (2001). – back to the text
16) See e.g. Eisenstadt v. Baird, 405 U.S. 438 (1972). Quoted in Andrews, L.B. and Rosenow, L. (2001). – back to the text
17) Planned Parenthood v. Casey, 505 U.S. 833, 112 S.Ct. 2791 (1992). Quoted in Andrews, L.B. and Rosenow, L. (2001). – back to the text
18) See the statement of John Robertson to the National Bioethics Advisory Commission, March 14, 1997, at 83. – back to the text
19) See Annas G. (1997), Testimony on Scientific Discoveries and Cloning: Challenges for Public Policy, before the Subcommittee on Public Health and Safety, Committee on Labor and Human Resources, U.S. Senate, March 12, p.4. – back to the text
20) See Kolata, G. (2001), "Parkinson’s Research Is Set Back By Failure of Fetal Cell Implants." The New York Times, March 8, pp. A1, A12. – back to the text
21) See http://bioethics.georgetown.edu/nbac/execsumm.pdf – back to the text
22) Statement of Alexander Morgan Capron before the
Subcommittee on Crime, Committee on the Judiciary, United States House of Representatives,
June 19, 2001.
See: http://bioethics.georgetown.edu/nbac/capron6_19.pdf – back to the text
23) For the NIH ‘Guidelines for Research Using Pluripotent Stem Cells’ see http://www.nih.gov/news/stemcell/stemcellguidelines.htm – back to the text
24) See Stolberg, S.G. (2001), "Washington Not Alone in Cell Debate." New York Times, 23 July, p. A12. – back to the text
25) For a complete list see http://www.nih.gov/news/stemcell/082701list.htm – back to the text
26) "White House Cuts Estimates of Available Stem Cells." Wall Street Journal, 6 September 2001, pp. A2, A24. – back to the text – back to the text
27) See http://www.nih.gov/news/pr/sep2001/od-05.htm – back to the text
28) "Geron Is Sued Over Control Of Stem Cells." Wall Street Journal, 14 August 2001, pp. A3, A8. – back to the text
29) "The Promise In Selling Stem Cells." New York Times, 26 August 2001, p. 3.1. – back to the text
30) "List of Stem Cell Researchers Shows Hans Had Been Tied." New York Times, 28 August 2001, p. A10. – back to the text
31) Doerflinger, R. (2001), "The Policy and Politics of Embryonic Stem Cell Research." The National Catholic Bioethics Quarterly, Vol. 1, No.2, pp. 135-143. – back to the text
32) However, a growing number of Catholic moral theologians do not consider the human embryo in its earliest stages to constitute an individual human entity with the inherent potential to become a human person. The moral status of the embryo is, therefore not that of a person, and its use for certain kinds of research can be justified. See Testimony of Margaret A. Farley for the National Bioethics Advisory Commission (2000). In: Ethical Issues In Human Stem Cell Research. Volume III. Religious Perspectives. P. D-4. – back to the text
33) Testimony of Father Demetrios Demepoulos for the National Bioethics Advisory Commission (2000). Ibd. P. B-3. – back to the text
34) Testimony of Abdulazis Sachedina for the National Bioethics Advisory Commission (2000).: "Islamic Perspectives on Research with Human Embryonic Stem Cells. Ibd. P. G-6. – back to the text
35) See http://www.aapd.com/ – back to the text
36) Personal communication with Andrew J. Imparato, President AAPD, October 16, 2001. – back to the text – back to the text
37) See www.gene-watch.org/programs/cloning/cloning_pp.html – back to the text
38) See www.gene-watch.org/programs/embryo/embryo.html – back to the text
39) See www.ourbodiesourselves.org/clone3.htm – back to the text
40) "Embryo Cloning and Stem Cell Research" Genetics Crossroads No. 19, E-Mail Newsletter, August 18, 2001. – back to the text
41) "Emergency Action for Women’s Lives: Statement of NOW President Patricia Ireland." Press release National Organization for Women, April 23, 2001. See http://www.commondreams.org/news2001/0423-07.htm – back to the text
42) Testimony of Rabbi Elliot N. Dorff for the National Bioethics Advisory Commission (2000). Ibd. P. C-3. – back to the text
43) See http://www.nap.edu/books/0309076307/html/ – back to the text
44) See www.bio.org/bioethics/ethics0117.htm – back to the text
45) Testimony of Carl B. Feldbaum before the Senate Commerce Committee Subcommittee on Science, Technology and Space, May 2, 2001. See http://www.bio.org/laws/tstm050201.html – back to the text
46) See www.geneticalliance.org – back to the text
47) Personal communication with Vicky Whittemore, Associate Director Genetic Alliance, October 15, 2001. – back to the text
48) Testimony of Ronald Cole-Turner for the National Bioethics Advisory Commission (2000). In: Ethical Issues In Human Stem Cell Research. Volume III. Religious Perspectives. P. A3. – back to the text
49) "List of Stem Cell Researchers Shows Hans Had Been Tied." New York Times, 28 August 2001, p. A10. – back to the text
50) "Stem Cells: Private Sector Can Do It Better." Wall Street Journal, 28 August 2001, p. A14. – back to the text
51) "Scientists Use Embryos Made Only for Research" (2001), Washington Post, July 11, p. A01. – back to the text
52) "Firm Aims To Clone Embryos for Stem Cells" (2001), Washington Post, July 12, p. A01. – back to the text
53) This compromise is favored for instance by the NBAC member Alexander Morgan Capron. See: Statement of Alexander Morgan Capron before the Subcommittee on Crime, Committee on the Judiciary, United States House of Representatives, June 19, 2001. http://bioethics.georgetown.edu/nbac/capron6_19.pdf – back to the text
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