Wednesday, August 21, 2019

Ethical Questions in the Stem Cell Debate

Ethical Questions in the Stem Cell Debate The Stem Cell Debate: Ethical Questions The story for the year 1997 was the sacred. We fear a Promethean blunder. We fear that our own human hubris will violate something sacred in our nature; and we fear that nature will retaliate with disaster. To protect ourselves from a possible Promethean blunder by science, we are tempted to stop further research with the commandment: thou shalt not play God! Then, during 1999, we opened the first few pages on chapter two of the cloning controversy story. I will refer to this chapter as the stem cell debate. The debate has only begun. What is not yet clear is just what needs to be debated. Perhaps nothing. Perhaps everything. What is clear is that the fallout from the cloning explosion is still lighting fires here and there. Whether or not the public will add stem cells to the fuel to make those fires burn hotter remains to be seen. Stem cells have become front page news in Australia, as well as in the United States and other countries. On February 4, 1999, the Australian National Academy of Science issued a position statement. Note the structure of Recommendation 1. Council considers that reproductive cloning to produce human fetuses is unethical and unsafe and should be prohibited.However, human cells derived from cloning techniques, from germ cells should not be precluded from use in approved research activities in cellular and developmental biology Here two things are put together. First, disapproval of reproductive cloning for the purposes of making children. Second, approval of research on human embryonic stem cells, approval even in the face of ethical squeamishness regarding embryo research. If this Australian statement is a barometer, we need to ask: what is the cultural weather forecast? What might be coming? In what follows it will be my task to report on the fast-moving frontier of stem cell research within the field of anthropology, agenda questions raised by science that need to be addressed by systematic theologians and public policy makers. I will ask more questions than I am ready to answer. Yet, I believe that such work invested in trying to formulate the relevant question (die Fragestellung) takes us more than just halfway toward a helpful answer. The Human Embryonic Stem Cell Debate Science, Ethics, and Public Policy Edited by Laurie Zoloth Human embryonic stem cells can divide indefinitely and have the potential to develop into many types of tissue. Research on these cells is essential to one of the most intriguing medical frontiers, regenerative medicine. It also raises a host of difficult ethical issues and has sparked great public interest and controversy. This book offers a foundation for thinking about the many issues involved in human embryonic stem cell research. It considers questions about the nature of human life, the limits of intervention into human cells and tissues, and the meaning of our corporeal existence. The fact that stem cells may be derived from living embryos that are destroyed in the process or from aborted fetuses ties the discussion of stem cell research to the ongoing debates on abortion. In addition to these issues, the essays in the book touch on broader questions such as who should approve controversial research and what constitutes human dignity, respect, and justice. The book contains contributions from the Ethics Advisory Board of the Geron Coroporation; excerpts from expert testimony given before the National Bioethics Advisory Commission, which helped shape recent National Institutes of Health policy; and original analytical essays on the implications of this research. Pros and Cons Debates over the ethics of embryonic blastocysts. Latest Developments The most recent research has shown that there are many options available other than working with embryonic stem cells. Stem cells can be obtained from cord blood or derived by manipulating differentiated cells (i.e. skin cells) to revert them to a pluripotent state. These are alternatives that may help broaden the acceptance of stem cell research. Background In November 1998 the first published research paper reported that stem cells could be taken from human embryos. Subsequent research led to the ability to maintain undifferentiated stem cell lines (pluripotent cells) and techniques for differentiating them into cells specific to various tissues and organs. The debates over the ethics of stem cell research began almost immediately in 1999, despite reports that stem cells cannot grow into complete organisms. In 2000 – 2001, governments worldwide were beginning to draft proposals and guidelines in an effort to control stem cell research and the handling of embryonic tissues, and reach universal policies to prevent â€Å"brain-drains† (emigration of top scientists) between countries. The CIHR (Canadian Institute of Health Sciences) drafted a list of recommendations for stem cell research in 2001. The Clinton administration drafted guidelines for stem cell research in 2000, but Clinton left office prior to them being released. The Bush government has had to deal with the issue throughout his administration. Australia, Germany, UK and other countries have also formulated policies. (Continued from Page 1) Pros The therapeutic cloning. Stem cells provide huge potential for finding treatments and cures to a vast array of diseases including different cancers, diabetes, spinal cord injuries, Alzheimers, MS, Huntingtons, Parkinsons and more. There is endless potential for scientists to learn about human growth and cell development from studying stem cells. Use of adult-derived stem cells, from blood, cord blood, skin and other tissues, known as IPSCs, has been demonstrated to be effective for treating different diseases in animal models. Umbilical-cord-derived stem cells (obtained from the cord blood) have also been isolated and utilized for various experimental treatments. Another option is use of uniparental stem cells. Although these cells lines have some disadvantages or shortcomings compared to embryonic cell lines (they are shorter-lived), there is vast potential if enough money is invested in researching them further, and they are not technically considered individual living beings by pro-life advocates. Cons Use of embryonic stem cells for reasearch involves the destruction of blastocysts formed from laboratory-fertilized human eggs. For those who believe that life begins at conception, the blastocyst is a human life and to destroy it is unacceptable and immoral. This seems to be the only controversial issue standing in the way of stem cell research in North America. Where It Stands In the summer of 2006 President Bush stood his ground on the issue of stem cell research and vetoed a bill passed by the Senate that would have expanded federal funding of embryonic stem cell research. Currently, American federal funding can only go to research on stem cells from existing (already destroyed) embryos. Similarly, in Canada, as of 2002, scientists cannot create or clone embryos for research but must used existing embryos discarded by couples. The UK allows embryonic stem cell cloning. Use of stem cell lines from alternative non-embryonic sources has received more attention in recent years and has already been demonstrated as a successful option for treatment of certain diseases. For example, adult stem cells can be used to replace blood-cell-forming cells killed during chemotherapy in bone marrow transplant patients. Biotech companies such as ACT are researching techniques for cellular reprogramming of adult cells, use of amnionic fluid, or stem cell extraction techniques that do not damage the embryo, that also provide alternatives for obtaining viable stem cell lines. Out of necessity, the research on these alternatives is catching up with embryonic stem cell research and, with sufficient funding, other solutions might be found that are acceptable to everyone. On March 9, 2009, President Obama overturned Bushs ruling, allowing US Federal funding to go to embryonic stem cell research. However, the stipulation applies that normal NIH policies on data sharing must be followed. Despite the progress being made in other areas of stem cell research, using pluripotent cells from other sources, many American scientists were putting pressure on the government to allow their participation and compete with the Europeans. However, many people are still strongly opposed Research Ethics and Stem Cells Stem cells show potential for many different areas of health and medical research, and studying them can help us understand how they transform into the dazzling array of specialized cells that make us what we are. Some of the most serious medical conditions, such as cancer and birth defects, are caused by problems that occur somewhere in this process. A better understanding of normal cell development will allow us to understand and perhaps correct the errors that cause these medical conditions. Research on one kind of stem cell—human embryonic stem cells—has generated much interest and public debate. Pluripotent stem cells (cells that can develop into many different cell types of the body) are isolated from human embryos that are a few days old. Pluripotent stem cell lines have also been developed from fetal tissue (older than 8 weeks of development). As science and technology continue to advance, so do ethical viewpoints surrounding these developments. It is important to educate and explore the issues, scientifically and ethically. The discovery, isolation, and culturing of human embryonic stem cells has been described as one of the most significant breakthroughs in biomedicine of the century.1 This description would be warranted by virtue of the biological uniqueness of these cells alone—their ability to self-renew infinitely while retaining a remarkable capacity to differentiate into any form of cell tissue. But as well as this, the culturing of embryonic stem cells holds tremendous potential for the development of new forms of regenerative medicine to treat debilitating or fatal conditions that would not otherwise be curable.2 It is somewhat of an irony that the discovery of cells with such a tremendous potential for improving and prolonging our own lives, should bring with it some of the most trenchant and intractable questions about the value of life itself. The harvesting of embryonic stem cells results in the destruction of the embryos from which they are harvested. It results, in other words, in the expiration of the very beginnings of a possible human life. Issues about the value of life emerge here in perhaps their most stark and poignant form in the question of whether life for those already existing should be improved at the seeming expense of a possible human life that has just come into being. Needless to say, what the most ethically justified response is to this sort of question is far from obvious. It is not immediately apparent, either, just what should count as the appropriate criteria for assessing possible responses to it. Indeed, it is even contentious as to what the right concepts and terminology are for framing the central questions. What is clear, though, is that it would be remiss to fail to engage with these questions in a manner that is commensurate with their depth, complexity and importance. With due regard to that, the following discussion provides a brief overview of some of the core ethical issues arising from the Research Involving Embryos Bill 2002 and to some extent the Prohibition of Human Cloning Bill 2002.3 The public debate has focused mostly on ethical problems associated with the destruction of embryos (in the case of the first Bill), and with the creation of cloned human embryos (in the case of the second Bill). The current paper will confine its primary focus to the first set of problems, since many of the salient ethical issues about cloning will arise, as it turns out, in connection with embryonic stem cell research.4 1 Key Ethical Issues in Embryonic Stem Cell Research The paper takes most of the major ethical concerns in the debate to be encompassed by the following core questions: †¢ What, in principle, is ethically at issue with destructive embryo research? †¢ What is important when it comes to judging the value of the potential consequences of destructive embryo research? †¢ In what does the value of the human embryo consist? †¢ Does the means by which an embryo expires—whether it is destroyed or merely succumbs—make a moral difference? †¢ Is there anything morally worse about using embryos created for research purposes compared to using existing excess or surplus ART (assisted reproductive treatment) embryos? The purpose of the following discussion is to clarify some relevant moral and conceptual distinctions connected with these core questions, and to clarify the basic structure of the major views and argument themes that have been developed by philosophers, bioethicists and theologians in response to these questions. Of course, in their more fully expanded form these distinctions and arguments will involve subtleties and complexities that are beyond the limited scope of this paper to address. Nonetheless, the discussion here will hopefully give an impression of where some of those further complexities and subtleties might lie. The Basic Ethical Problem The possibility of destructive embryo research, particularly embryonic stem cell research, presents us with a moral problem because it appears to bring into tension two fundamental moral principles that we esteem very highly: one principle enjoins the prevention or alleviation of suffering, and the other enjoins us to respect the value of human life. As noted, the harvesting and culturing of embryonic stem cells has considerable potential to bring about remarkable potential benefits in the way of alleviating debilitating medical conditions. So, it satisfies the first principle to a very great degree. On the other hand, there is a case to be made that the harvesting of human embryonic stem cells violates the second principle in that it results in the destruction of human life with value (i.e. human embryos). Accordingly, both principles apparently cannot simultaneously be respected in the case of embryonic stem cell research. The question then is which principle ought to be given precedence in this conflict situation. Should we give more weight to the first, and permit destructive embryonic stem cell research because of its remarkable potential benefits? Or should we give more weight to the second, and prohibit destructive embryonic research because it violates respect for the value of the 2 Key Ethical Issues in Embryonic Stem Cell Research embryo as the very beginnings of a possible human life? This, at bottom, is the ethical problem generated by destructive embryo research. Crude as it may sound, responding to this problem calls for a moral calculation—a decision about how the positive value of destructive embryo research is to be weighted, from a moral point of view, in comparison to the negative value (or disvalue) of destroying embryos. Whatever way that calculation is done, it is important to get a clear idea of what moral weight each side of the equation has. This will involve: (i) developing a sound and accurate picture of what the real value is of the benefits of embryonic research, and (ii) clarifying what the value of embryos might consist in, and what, if anything, may be wrong with destroying them. The rest of this paper outlines some of the ethical arguments and philosophical considerations that have been considered relevant to these two matters. Evaluating the Benefits of Embryonic Stem Cell Research Evaluating the beneficial consequences of embryonic stem cell research is not straightforward. There are complexities associated with assessing how realistic the potential of the benefits is, how alternatives with different combinations of benefits and drawbacks are to be compared, and factoring in all of the sometimes overlooked possible consequences of embryonic research. Judging the Benefits Most attention has centred on the medical potential of embryonic stem cell research and cultivation, particularly somatic gene therapy for genetic disorders5, and the generation of replacement tissues and organs for transplant.6 There is no doubt that these outcomes, once realised, would be highly valuable. It is important to keep in mind, however, that currently these benefits are potential ones. A sound evaluation of stem cell research needs to take account of the likelihood of achieving its beneficial outcomes. In matters of science, and particularly, in areas that are newly developing and comparatively uncharted (such as embryonic stem cell research), it is sometimes difficult to settle on those probabilities with complete confidence. It is the nature of scientific discoveries and progress, that they are not easily predicted. Both advances and impediments to advancement can arise unexpectedly. This uncertainty about how real the potential benefits are, needs to be kept in mind wh en weighing and evaluating the consequences of embryonic stem cell research. 3 Key Ethical Issues in Embryonic Stem Cell Research Comparing the Benefits and Harms of Alternatives to Embryonic Stem Cell Research Adult Stem Cell Research Whether destructive embryonic stem cell research is the right thing to do or not, will partly depend on what the alternatives are, and how their particular benefits and drawbacks balance out. There is another research program involving adult stem cells that are present in and drawn from bone marrow, brain and gut, and other tissues. Some of these stem cells have a capacity to differentiate into a limited number of different cell types, such as blood cells, muscles and neurones (i.e., they are multipotent), but they have not been shown to be pluripotent (able to differentiate into any cell-type) in the way that embryonic stem cells are.7 This limitation means that adult stem cells offer more limited potential benefits in regenerative medicine and gene therapy, at least from the standpoint of our current understanding and available biotechnology. (But with that said, it is worth keeping in mind the points made above about the limited predictability of scientific advances, including the possibility of inducing adult stem cells to differentiate into a greater range of tissue types.) The harvesting and use of adult stem cells for biomedical purposes, however, avoids some of the ethically and biomedically problematic features of using embryonic stem cells. For a start, harvesting adult stem cells does not involve the destruction of embryos. The extent to which that is an advantage will depend on the extent to which that destruction turns out to be a bad thing, (and this will be taken up shortly). Tissues grown from adult stem cells will be immunologically compatible with the person from whom the stem cells are harvested. This means that those tissues can be transplanted into that person without fear of the body rejecting them. Tissues produced from embryonic stem cells for the purpose of regenerative therapy, however, are unlikely to be immunocompatible with the person for whom they are intended. The immunological properties of the tissue are set by the characteristics of whatever embryo the stem cells are derived from. Apart from the ongoing use of immunosuppressant drugs (with its possible serious side effects), two other potential solutions to this immunological limitation have been suggested. The first proposes a tissue bank with a sufficiently large number of different embryonic stem cell types to generate tissue that can be immunologically matched with different recipients. Hall points out, however, that this would require a huge number of human embryonic stem cell lines (the number being a matter of debate). Such an embryonic stem cell bank would be technically difficult and expensive to generate. The number of embryos that would be required to produce the cell bank would probably test public support †¦ 8. The second possible way of overcoming the problem of immunological incompatibility is through what has been called therapeutic cloning. In this process, the nucleus of a human oocyte or egg is removed and replaced with the nucleus of a cell taken from the body of the intended tissue re cipient. The new egg is induced to develop into an embryo, from which immunocompatible stem cells are harvested. The embryo will be a human embryonic clone of the recipient, with all his/her 4 Key Ethical Issues in Embryonic Stem Cell Research exact genetic characteristics. To date, there have only been one or two reported attempts at human cloning that have met with some success. A number of ethical objections have been expressed to therapeutic cloning, all revolving around the creating of an embryo, and moreover, the creating of an embryo for a use that will destroy it. These objections and arguments usually rely centrally on certain views about the value or moral status of the embryo, and these views will be outlined later in the paper. Whatever benefit the pluripotency of embryonic stem cells has in generating immunocompatible tissue, this benefit is likely to be possible only at the cost of having to engage in either the morally contentious practice of human (therapeutic) cloning, or the morally contentious practice of using (and destroying) a large number of embryos to create a sufficient range of embryonic stem cell lines for organ banks. It is especially important to note also, that if the Prohibition of Human Cloning Bill 2002 is passed in its current form, and any kind of human cloning, including therapeutic cloning, is prohibited, there will be less opportunity to maximise the potential benefits of embryonic stem cell research, and embryonic stem cells will effectively have less of the advantage they would otherwise have over adult stem cells. The Inevitable Succumbing of Surplus IVF Embryos The Research Involving Embryos Bill 2002 only permits excess ART embryos existing before 5 April 2002 to be used for research purposes in accordance with a licensing regime. It is a fact about those embryos that they would likely expire or succumb anyway. They would still be destroyed, in other words, but through exposure to natural processes. On the face of it, this looks as if the harm or negative value involved in embryos expiring (whatever it might be) will be the same whether embryo research is allowed or not. In each case the embryo will expire. But this impression can be a little oversimplified. Some philosophers argue that there is a moral difference between acts and omissions, between actively killing something, and passively failing to intervene to stop its death from other causes (when one could have). Even though the outcome is the same in each case, it can be argued that there is something worse, or more morally culpable, about actively bringing about the death oneself. There are different views on what the moral difference between killing and letting die amounts to, and there are those who argue that there is no significant difference. Whichever way one comes out on this, it is not clear that the act-omission distinction maps neatly onto the particular embryo research scenario under discussion. Destroying surplus embryos through research is certainly an act. But so too, some would argue, is removing surplus embryos from the cold storage that keeps them from expiring. They would hold that this looks less like failing to intervene in independently occurring causal processes (that will lead to expiry), than an act that sets those processes in motion. If this is true, then the first impression above will stand. The harm or negative value involved in embryos expiring (whatever it might be) will be the same whether embryo research is allowed or not. 5 Key Ethical Issues in Embryonic Stem Cell Research Some would argue that there is an important logical upshot from this. If the only two alternatives in the circumstances (destroying embryos in research vs making them succumb) involve the same level of harm or disvalue or moral wrongness, but embryo research involves much greater benefits than the other alternative, then it could be argued, it makes sense to opt for the more beneficial embryo research. And indeed, some might construe that as a sufficient case for the moral preferability of that option. (This would change, of course, if the relevant alternatives change—if say, embryos were purpose created for research, which were not pre-existing and destined to be expired).9 Taking into Account all of the Relevant Benefits and Harms The embryonic stem cell debate has been pre-occupied with the biological and medical benefits or drawbacks of that research. Central as these certainly are, there are nonetheless other, often-overlooked non-medical impacts that may be important to factor in. Some of the major among these are possible social impacts including: De-sensitisation to the Destruction of Human Life It is argued by some10 that allowing the destruction of embryos to become an entrenched practice would serve to desensitise the scientific establishment, regulating bodies, and society in general, to the destruction of life in general. An increased social toleration of loss of life, it would be argued, may make it easier for society to accede to (currently) more controversial practices involving the ending of life such as, late term elective abortion, or withdrawal of treatment for severely disabled infants, for example. This slippery slope argument about potential consequences is based on empirical assumptions about the causes and effects of certain social attitudes, and needs to be assessed in the light of their plausibility. Contributions to Social Oppression One strong but minority strand of argument emphasises the impact that biotechnology has on broader social relationships. It has been argued that research should be evaluated not only in terms of its effects on the subjects of the experiment but also in terms of its connection with existing patterns of oppression and domination in society.11 There is a considerable body of writing that explores the impacts of new reproductive technologies (such as IVF) on the interests of women, particularly how those technologies might contribute to oppression.12 In the case of embryonic research, it is sometimes argued that women who donate ova or embryos are at risk of exploitation to the extent that male-dominated medical practice appropriates their reproductive labour for research and commercial benefits. Women are at risk, therefore, of being alienated from their reproductive labour. Moreover, it is argued that womens body parts are at risk of being commodified, and their acts of altruistic dona tion demeaned, if downstream users can develop commercial applications for stem cells developed from their ova and embryos.13 6 Key Ethical Issues in Embryonic Stem Cell Research The Value of the Embryo What weight does the other side of the moral equation have? What is wrong, if anything, with destroying embryos? If there is something wrong with that, is it sufficiently wrong to outweigh or override the benefits of embryo research, and therefore, render that research morally impermissible? Most of the leading arguments about the rightness or wrongness of destroying embryos are based on some view or other about the moral status of the embryo—how the embryo ought to be regarded or treated from the moral point of view, in virtue of it arguably possessing certain morally important intrinsic characteristics. It is relatively uncontroversial to describe embryos as human life (at its very beginnings). It is another thing, however, to describe embryos as persons, or human beings, or potential persons, etc. These descriptions are morally laden in that they carry with them potential implications about what can and cannot be done to embryos from a moral point of view. What those potential implications are, and indeed, whether they are sound ones, will depend on the nature and plausibility of the particular arguments that accompany each view on the moral status of the embryo. There are different views about this moral status. The leading views speculate that embryos have the status of: †¢ persons, or †¢ potential persons, or †¢ divine creations, or †¢ subjects of moral harm, or †¢ the beginnings of human life, with intrinsic value, or †¢ organic material with no more moral standing than other body parts. Each of these will be outlined in turn, with particular attention to (i) what the intrinsic moral characteristics are the each particular view attributes to embryos, and (ii) what these alleged characteristics or moral status are held to imply for our moral treatment of embryos—particularly whether they can ever or never be destroyed. Embryos have Status as Human Beings or Persons Some argue that, despite obvious physical differences between developed humans and embryos, the latter ought still be regarded as human beings or persons. One of the more plausible arguments to this effect relies on pointing out that there is no non-arbitrary point in the physical growth continuum between embryo and developed human that counts as a morally significant dividing line.14 Consequently, if individuals at their fully developed stage are human beings or persons, there is no non-arbitrary ground to think that they should not count as the same at their embryonic stage. Those who hold otherwise, 7 Key Ethical Issues in Embryonic Stem Cell Research according to this argument, need to indicate the developmental point at which personhood, or status as a human being, is acquired. The argument continues that it is a very deeply and commonly held view in modern liberal democracies that individual persons are deserving of especially strong moral respect in certain ways. All individuals, by virtue of being persons, have fundamental rights not to have their basic human interests interfered with in certain ways, and most importantly, their interest in the maintenance of their life and bodily integrity. If embryos have the status of persons, then they too will have rights not to be harmed or killed. Or, put in another way, we will be under a very strong moral obligation not to harm or kill embryos. Most prominent ethicists, philosophers and commentators would agree that persons have a status deserving of strong and special moral respect, protection and dignity. Many, however, would dispute that embryos should be considered persons or human beings in any serious sense. Even if one cannot point to an exact black and white dividing line in human development, it is still reasonable (they hold) to point to the fact that wherever the transition occurs, embryos do not have the psychological, physiological, emotional, intellectual properties that we tend to centrally associate with personhood. Embryos, particularly the very early pre-implantation blastocysts involved in stem cell research,15 do not, for instance, have consciousness, individuality, the ability to reason, or the ability to form courses of action in life and to choose between them.16 Embryos have Status as Potential Persons Some ethicists have a response to the foregoing objection to viewing embryos as persons. It is to concede that embryos do not currently exhibit these properties of personhood, but they will, if allowed to develop and fulfil their potential. To the extent that embryos are potential persons, it is argued, they ought to still be accorded the moral respect and dignity that personhood warrants. This potential person argument Ethical Questions in the Stem Cell Debate Ethical Questions in the Stem Cell Debate The Stem Cell Debate: Ethical Questions The story for the year 1997 was the sacred. We fear a Promethean blunder. We fear that our own human hubris will violate something sacred in our nature; and we fear that nature will retaliate with disaster. To protect ourselves from a possible Promethean blunder by science, we are tempted to stop further research with the commandment: thou shalt not play God! Then, during 1999, we opened the first few pages on chapter two of the cloning controversy story. I will refer to this chapter as the stem cell debate. The debate has only begun. What is not yet clear is just what needs to be debated. Perhaps nothing. Perhaps everything. What is clear is that the fallout from the cloning explosion is still lighting fires here and there. Whether or not the public will add stem cells to the fuel to make those fires burn hotter remains to be seen. Stem cells have become front page news in Australia, as well as in the United States and other countries. On February 4, 1999, the Australian National Academy of Science issued a position statement. Note the structure of Recommendation 1. Council considers that reproductive cloning to produce human fetuses is unethical and unsafe and should be prohibited.However, human cells derived from cloning techniques, from germ cells should not be precluded from use in approved research activities in cellular and developmental biology Here two things are put together. First, disapproval of reproductive cloning for the purposes of making children. Second, approval of research on human embryonic stem cells, approval even in the face of ethical squeamishness regarding embryo research. If this Australian statement is a barometer, we need to ask: what is the cultural weather forecast? What might be coming? In what follows it will be my task to report on the fast-moving frontier of stem cell research within the field of anthropology, agenda questions raised by science that need to be addressed by systematic theologians and public policy makers. I will ask more questions than I am ready to answer. Yet, I believe that such work invested in trying to formulate the relevant question (die Fragestellung) takes us more than just halfway toward a helpful answer. The Human Embryonic Stem Cell Debate Science, Ethics, and Public Policy Edited by Laurie Zoloth Human embryonic stem cells can divide indefinitely and have the potential to develop into many types of tissue. Research on these cells is essential to one of the most intriguing medical frontiers, regenerative medicine. It also raises a host of difficult ethical issues and has sparked great public interest and controversy. This book offers a foundation for thinking about the many issues involved in human embryonic stem cell research. It considers questions about the nature of human life, the limits of intervention into human cells and tissues, and the meaning of our corporeal existence. The fact that stem cells may be derived from living embryos that are destroyed in the process or from aborted fetuses ties the discussion of stem cell research to the ongoing debates on abortion. In addition to these issues, the essays in the book touch on broader questions such as who should approve controversial research and what constitutes human dignity, respect, and justice. The book contains contributions from the Ethics Advisory Board of the Geron Coroporation; excerpts from expert testimony given before the National Bioethics Advisory Commission, which helped shape recent National Institutes of Health policy; and original analytical essays on the implications of this research. Pros and Cons Debates over the ethics of embryonic blastocysts. Latest Developments The most recent research has shown that there are many options available other than working with embryonic stem cells. Stem cells can be obtained from cord blood or derived by manipulating differentiated cells (i.e. skin cells) to revert them to a pluripotent state. These are alternatives that may help broaden the acceptance of stem cell research. Background In November 1998 the first published research paper reported that stem cells could be taken from human embryos. Subsequent research led to the ability to maintain undifferentiated stem cell lines (pluripotent cells) and techniques for differentiating them into cells specific to various tissues and organs. The debates over the ethics of stem cell research began almost immediately in 1999, despite reports that stem cells cannot grow into complete organisms. In 2000 – 2001, governments worldwide were beginning to draft proposals and guidelines in an effort to control stem cell research and the handling of embryonic tissues, and reach universal policies to prevent â€Å"brain-drains† (emigration of top scientists) between countries. The CIHR (Canadian Institute of Health Sciences) drafted a list of recommendations for stem cell research in 2001. The Clinton administration drafted guidelines for stem cell research in 2000, but Clinton left office prior to them being released. The Bush government has had to deal with the issue throughout his administration. Australia, Germany, UK and other countries have also formulated policies. (Continued from Page 1) Pros The therapeutic cloning. Stem cells provide huge potential for finding treatments and cures to a vast array of diseases including different cancers, diabetes, spinal cord injuries, Alzheimers, MS, Huntingtons, Parkinsons and more. There is endless potential for scientists to learn about human growth and cell development from studying stem cells. Use of adult-derived stem cells, from blood, cord blood, skin and other tissues, known as IPSCs, has been demonstrated to be effective for treating different diseases in animal models. Umbilical-cord-derived stem cells (obtained from the cord blood) have also been isolated and utilized for various experimental treatments. Another option is use of uniparental stem cells. Although these cells lines have some disadvantages or shortcomings compared to embryonic cell lines (they are shorter-lived), there is vast potential if enough money is invested in researching them further, and they are not technically considered individual living beings by pro-life advocates. Cons Use of embryonic stem cells for reasearch involves the destruction of blastocysts formed from laboratory-fertilized human eggs. For those who believe that life begins at conception, the blastocyst is a human life and to destroy it is unacceptable and immoral. This seems to be the only controversial issue standing in the way of stem cell research in North America. Where It Stands In the summer of 2006 President Bush stood his ground on the issue of stem cell research and vetoed a bill passed by the Senate that would have expanded federal funding of embryonic stem cell research. Currently, American federal funding can only go to research on stem cells from existing (already destroyed) embryos. Similarly, in Canada, as of 2002, scientists cannot create or clone embryos for research but must used existing embryos discarded by couples. The UK allows embryonic stem cell cloning. Use of stem cell lines from alternative non-embryonic sources has received more attention in recent years and has already been demonstrated as a successful option for treatment of certain diseases. For example, adult stem cells can be used to replace blood-cell-forming cells killed during chemotherapy in bone marrow transplant patients. Biotech companies such as ACT are researching techniques for cellular reprogramming of adult cells, use of amnionic fluid, or stem cell extraction techniques that do not damage the embryo, that also provide alternatives for obtaining viable stem cell lines. Out of necessity, the research on these alternatives is catching up with embryonic stem cell research and, with sufficient funding, other solutions might be found that are acceptable to everyone. On March 9, 2009, President Obama overturned Bushs ruling, allowing US Federal funding to go to embryonic stem cell research. However, the stipulation applies that normal NIH policies on data sharing must be followed. Despite the progress being made in other areas of stem cell research, using pluripotent cells from other sources, many American scientists were putting pressure on the government to allow their participation and compete with the Europeans. However, many people are still strongly opposed Research Ethics and Stem Cells Stem cells show potential for many different areas of health and medical research, and studying them can help us understand how they transform into the dazzling array of specialized cells that make us what we are. Some of the most serious medical conditions, such as cancer and birth defects, are caused by problems that occur somewhere in this process. A better understanding of normal cell development will allow us to understand and perhaps correct the errors that cause these medical conditions. Research on one kind of stem cell—human embryonic stem cells—has generated much interest and public debate. Pluripotent stem cells (cells that can develop into many different cell types of the body) are isolated from human embryos that are a few days old. Pluripotent stem cell lines have also been developed from fetal tissue (older than 8 weeks of development). As science and technology continue to advance, so do ethical viewpoints surrounding these developments. It is important to educate and explore the issues, scientifically and ethically. The discovery, isolation, and culturing of human embryonic stem cells has been described as one of the most significant breakthroughs in biomedicine of the century.1 This description would be warranted by virtue of the biological uniqueness of these cells alone—their ability to self-renew infinitely while retaining a remarkable capacity to differentiate into any form of cell tissue. But as well as this, the culturing of embryonic stem cells holds tremendous potential for the development of new forms of regenerative medicine to treat debilitating or fatal conditions that would not otherwise be curable.2 It is somewhat of an irony that the discovery of cells with such a tremendous potential for improving and prolonging our own lives, should bring with it some of the most trenchant and intractable questions about the value of life itself. The harvesting of embryonic stem cells results in the destruction of the embryos from which they are harvested. It results, in other words, in the expiration of the very beginnings of a possible human life. Issues about the value of life emerge here in perhaps their most stark and poignant form in the question of whether life for those already existing should be improved at the seeming expense of a possible human life that has just come into being. Needless to say, what the most ethically justified response is to this sort of question is far from obvious. It is not immediately apparent, either, just what should count as the appropriate criteria for assessing possible responses to it. Indeed, it is even contentious as to what the right concepts and terminology are for framing the central questions. What is clear, though, is that it would be remiss to fail to engage with these questions in a manner that is commensurate with their depth, complexity and importance. With due regard to that, the following discussion provides a brief overview of some of the core ethical issues arising from the Research Involving Embryos Bill 2002 and to some extent the Prohibition of Human Cloning Bill 2002.3 The public debate has focused mostly on ethical problems associated with the destruction of embryos (in the case of the first Bill), and with the creation of cloned human embryos (in the case of the second Bill). The current paper will confine its primary focus to the first set of problems, since many of the salient ethical issues about cloning will arise, as it turns out, in connection with embryonic stem cell research.4 1 Key Ethical Issues in Embryonic Stem Cell Research The paper takes most of the major ethical concerns in the debate to be encompassed by the following core questions: †¢ What, in principle, is ethically at issue with destructive embryo research? †¢ What is important when it comes to judging the value of the potential consequences of destructive embryo research? †¢ In what does the value of the human embryo consist? †¢ Does the means by which an embryo expires—whether it is destroyed or merely succumbs—make a moral difference? †¢ Is there anything morally worse about using embryos created for research purposes compared to using existing excess or surplus ART (assisted reproductive treatment) embryos? The purpose of the following discussion is to clarify some relevant moral and conceptual distinctions connected with these core questions, and to clarify the basic structure of the major views and argument themes that have been developed by philosophers, bioethicists and theologians in response to these questions. Of course, in their more fully expanded form these distinctions and arguments will involve subtleties and complexities that are beyond the limited scope of this paper to address. Nonetheless, the discussion here will hopefully give an impression of where some of those further complexities and subtleties might lie. The Basic Ethical Problem The possibility of destructive embryo research, particularly embryonic stem cell research, presents us with a moral problem because it appears to bring into tension two fundamental moral principles that we esteem very highly: one principle enjoins the prevention or alleviation of suffering, and the other enjoins us to respect the value of human life. As noted, the harvesting and culturing of embryonic stem cells has considerable potential to bring about remarkable potential benefits in the way of alleviating debilitating medical conditions. So, it satisfies the first principle to a very great degree. On the other hand, there is a case to be made that the harvesting of human embryonic stem cells violates the second principle in that it results in the destruction of human life with value (i.e. human embryos). Accordingly, both principles apparently cannot simultaneously be respected in the case of embryonic stem cell research. The question then is which principle ought to be given precedence in this conflict situation. Should we give more weight to the first, and permit destructive embryonic stem cell research because of its remarkable potential benefits? Or should we give more weight to the second, and prohibit destructive embryonic research because it violates respect for the value of the 2 Key Ethical Issues in Embryonic Stem Cell Research embryo as the very beginnings of a possible human life? This, at bottom, is the ethical problem generated by destructive embryo research. Crude as it may sound, responding to this problem calls for a moral calculation—a decision about how the positive value of destructive embryo research is to be weighted, from a moral point of view, in comparison to the negative value (or disvalue) of destroying embryos. Whatever way that calculation is done, it is important to get a clear idea of what moral weight each side of the equation has. This will involve: (i) developing a sound and accurate picture of what the real value is of the benefits of embryonic research, and (ii) clarifying what the value of embryos might consist in, and what, if anything, may be wrong with destroying them. The rest of this paper outlines some of the ethical arguments and philosophical considerations that have been considered relevant to these two matters. Evaluating the Benefits of Embryonic Stem Cell Research Evaluating the beneficial consequences of embryonic stem cell research is not straightforward. There are complexities associated with assessing how realistic the potential of the benefits is, how alternatives with different combinations of benefits and drawbacks are to be compared, and factoring in all of the sometimes overlooked possible consequences of embryonic research. Judging the Benefits Most attention has centred on the medical potential of embryonic stem cell research and cultivation, particularly somatic gene therapy for genetic disorders5, and the generation of replacement tissues and organs for transplant.6 There is no doubt that these outcomes, once realised, would be highly valuable. It is important to keep in mind, however, that currently these benefits are potential ones. A sound evaluation of stem cell research needs to take account of the likelihood of achieving its beneficial outcomes. In matters of science, and particularly, in areas that are newly developing and comparatively uncharted (such as embryonic stem cell research), it is sometimes difficult to settle on those probabilities with complete confidence. It is the nature of scientific discoveries and progress, that they are not easily predicted. Both advances and impediments to advancement can arise unexpectedly. This uncertainty about how real the potential benefits are, needs to be kept in mind wh en weighing and evaluating the consequences of embryonic stem cell research. 3 Key Ethical Issues in Embryonic Stem Cell Research Comparing the Benefits and Harms of Alternatives to Embryonic Stem Cell Research Adult Stem Cell Research Whether destructive embryonic stem cell research is the right thing to do or not, will partly depend on what the alternatives are, and how their particular benefits and drawbacks balance out. There is another research program involving adult stem cells that are present in and drawn from bone marrow, brain and gut, and other tissues. Some of these stem cells have a capacity to differentiate into a limited number of different cell types, such as blood cells, muscles and neurones (i.e., they are multipotent), but they have not been shown to be pluripotent (able to differentiate into any cell-type) in the way that embryonic stem cells are.7 This limitation means that adult stem cells offer more limited potential benefits in regenerative medicine and gene therapy, at least from the standpoint of our current understanding and available biotechnology. (But with that said, it is worth keeping in mind the points made above about the limited predictability of scientific advances, including the possibility of inducing adult stem cells to differentiate into a greater range of tissue types.) The harvesting and use of adult stem cells for biomedical purposes, however, avoids some of the ethically and biomedically problematic features of using embryonic stem cells. For a start, harvesting adult stem cells does not involve the destruction of embryos. The extent to which that is an advantage will depend on the extent to which that destruction turns out to be a bad thing, (and this will be taken up shortly). Tissues grown from adult stem cells will be immunologically compatible with the person from whom the stem cells are harvested. This means that those tissues can be transplanted into that person without fear of the body rejecting them. Tissues produced from embryonic stem cells for the purpose of regenerative therapy, however, are unlikely to be immunocompatible with the person for whom they are intended. The immunological properties of the tissue are set by the characteristics of whatever embryo the stem cells are derived from. Apart from the ongoing use of immunosuppressant drugs (with its possible serious side effects), two other potential solutions to this immunological limitation have been suggested. The first proposes a tissue bank with a sufficiently large number of different embryonic stem cell types to generate tissue that can be immunologically matched with different recipients. Hall points out, however, that this would require a huge number of human embryonic stem cell lines (the number being a matter of debate). Such an embryonic stem cell bank would be technically difficult and expensive to generate. The number of embryos that would be required to produce the cell bank would probably test public support †¦ 8. The second possible way of overcoming the problem of immunological incompatibility is through what has been called therapeutic cloning. In this process, the nucleus of a human oocyte or egg is removed and replaced with the nucleus of a cell taken from the body of the intended tissue re cipient. The new egg is induced to develop into an embryo, from which immunocompatible stem cells are harvested. The embryo will be a human embryonic clone of the recipient, with all his/her 4 Key Ethical Issues in Embryonic Stem Cell Research exact genetic characteristics. To date, there have only been one or two reported attempts at human cloning that have met with some success. A number of ethical objections have been expressed to therapeutic cloning, all revolving around the creating of an embryo, and moreover, the creating of an embryo for a use that will destroy it. These objections and arguments usually rely centrally on certain views about the value or moral status of the embryo, and these views will be outlined later in the paper. Whatever benefit the pluripotency of embryonic stem cells has in generating immunocompatible tissue, this benefit is likely to be possible only at the cost of having to engage in either the morally contentious practice of human (therapeutic) cloning, or the morally contentious practice of using (and destroying) a large number of embryos to create a sufficient range of embryonic stem cell lines for organ banks. It is especially important to note also, that if the Prohibition of Human Cloning Bill 2002 is passed in its current form, and any kind of human cloning, including therapeutic cloning, is prohibited, there will be less opportunity to maximise the potential benefits of embryonic stem cell research, and embryonic stem cells will effectively have less of the advantage they would otherwise have over adult stem cells. The Inevitable Succumbing of Surplus IVF Embryos The Research Involving Embryos Bill 2002 only permits excess ART embryos existing before 5 April 2002 to be used for research purposes in accordance with a licensing regime. It is a fact about those embryos that they would likely expire or succumb anyway. They would still be destroyed, in other words, but through exposure to natural processes. On the face of it, this looks as if the harm or negative value involved in embryos expiring (whatever it might be) will be the same whether embryo research is allowed or not. In each case the embryo will expire. But this impression can be a little oversimplified. Some philosophers argue that there is a moral difference between acts and omissions, between actively killing something, and passively failing to intervene to stop its death from other causes (when one could have). Even though the outcome is the same in each case, it can be argued that there is something worse, or more morally culpable, about actively bringing about the death oneself. There are different views on what the moral difference between killing and letting die amounts to, and there are those who argue that there is no significant difference. Whichever way one comes out on this, it is not clear that the act-omission distinction maps neatly onto the particular embryo research scenario under discussion. Destroying surplus embryos through research is certainly an act. But so too, some would argue, is removing surplus embryos from the cold storage that keeps them from expiring. They would hold that this looks less like failing to intervene in independently occurring causal processes (that will lead to expiry), than an act that sets those processes in motion. If this is true, then the first impression above will stand. The harm or negative value involved in embryos expiring (whatever it might be) will be the same whether embryo research is allowed or not. 5 Key Ethical Issues in Embryonic Stem Cell Research Some would argue that there is an important logical upshot from this. If the only two alternatives in the circumstances (destroying embryos in research vs making them succumb) involve the same level of harm or disvalue or moral wrongness, but embryo research involves much greater benefits than the other alternative, then it could be argued, it makes sense to opt for the more beneficial embryo research. And indeed, some might construe that as a sufficient case for the moral preferability of that option. (This would change, of course, if the relevant alternatives change—if say, embryos were purpose created for research, which were not pre-existing and destined to be expired).9 Taking into Account all of the Relevant Benefits and Harms The embryonic stem cell debate has been pre-occupied with the biological and medical benefits or drawbacks of that research. Central as these certainly are, there are nonetheless other, often-overlooked non-medical impacts that may be important to factor in. Some of the major among these are possible social impacts including: De-sensitisation to the Destruction of Human Life It is argued by some10 that allowing the destruction of embryos to become an entrenched practice would serve to desensitise the scientific establishment, regulating bodies, and society in general, to the destruction of life in general. An increased social toleration of loss of life, it would be argued, may make it easier for society to accede to (currently) more controversial practices involving the ending of life such as, late term elective abortion, or withdrawal of treatment for severely disabled infants, for example. This slippery slope argument about potential consequences is based on empirical assumptions about the causes and effects of certain social attitudes, and needs to be assessed in the light of their plausibility. Contributions to Social Oppression One strong but minority strand of argument emphasises the impact that biotechnology has on broader social relationships. It has been argued that research should be evaluated not only in terms of its effects on the subjects of the experiment but also in terms of its connection with existing patterns of oppression and domination in society.11 There is a considerable body of writing that explores the impacts of new reproductive technologies (such as IVF) on the interests of women, particularly how those technologies might contribute to oppression.12 In the case of embryonic research, it is sometimes argued that women who donate ova or embryos are at risk of exploitation to the extent that male-dominated medical practice appropriates their reproductive labour for research and commercial benefits. Women are at risk, therefore, of being alienated from their reproductive labour. Moreover, it is argued that womens body parts are at risk of being commodified, and their acts of altruistic dona tion demeaned, if downstream users can develop commercial applications for stem cells developed from their ova and embryos.13 6 Key Ethical Issues in Embryonic Stem Cell Research The Value of the Embryo What weight does the other side of the moral equation have? What is wrong, if anything, with destroying embryos? If there is something wrong with that, is it sufficiently wrong to outweigh or override the benefits of embryo research, and therefore, render that research morally impermissible? Most of the leading arguments about the rightness or wrongness of destroying embryos are based on some view or other about the moral status of the embryo—how the embryo ought to be regarded or treated from the moral point of view, in virtue of it arguably possessing certain morally important intrinsic characteristics. It is relatively uncontroversial to describe embryos as human life (at its very beginnings). It is another thing, however, to describe embryos as persons, or human beings, or potential persons, etc. These descriptions are morally laden in that they carry with them potential implications about what can and cannot be done to embryos from a moral point of view. What those potential implications are, and indeed, whether they are sound ones, will depend on the nature and plausibility of the particular arguments that accompany each view on the moral status of the embryo. There are different views about this moral status. The leading views speculate that embryos have the status of: †¢ persons, or †¢ potential persons, or †¢ divine creations, or †¢ subjects of moral harm, or †¢ the beginnings of human life, with intrinsic value, or †¢ organic material with no more moral standing than other body parts. Each of these will be outlined in turn, with particular attention to (i) what the intrinsic moral characteristics are the each particular view attributes to embryos, and (ii) what these alleged characteristics or moral status are held to imply for our moral treatment of embryos—particularly whether they can ever or never be destroyed. Embryos have Status as Human Beings or Persons Some argue that, despite obvious physical differences between developed humans and embryos, the latter ought still be regarded as human beings or persons. One of the more plausible arguments to this effect relies on pointing out that there is no non-arbitrary point in the physical growth continuum between embryo and developed human that counts as a morally significant dividing line.14 Consequently, if individuals at their fully developed stage are human beings or persons, there is no non-arbitrary ground to think that they should not count as the same at their embryonic stage. Those who hold otherwise, 7 Key Ethical Issues in Embryonic Stem Cell Research according to this argument, need to indicate the developmental point at which personhood, or status as a human being, is acquired. The argument continues that it is a very deeply and commonly held view in modern liberal democracies that individual persons are deserving of especially strong moral respect in certain ways. All individuals, by virtue of being persons, have fundamental rights not to have their basic human interests interfered with in certain ways, and most importantly, their interest in the maintenance of their life and bodily integrity. If embryos have the status of persons, then they too will have rights not to be harmed or killed. Or, put in another way, we will be under a very strong moral obligation not to harm or kill embryos. Most prominent ethicists, philosophers and commentators would agree that persons have a status deserving of strong and special moral respect, protection and dignity. Many, however, would dispute that embryos should be considered persons or human beings in any serious sense. Even if one cannot point to an exact black and white dividing line in human development, it is still reasonable (they hold) to point to the fact that wherever the transition occurs, embryos do not have the psychological, physiological, emotional, intellectual properties that we tend to centrally associate with personhood. Embryos, particularly the very early pre-implantation blastocysts involved in stem cell research,15 do not, for instance, have consciousness, individuality, the ability to reason, or the ability to form courses of action in life and to choose between them.16 Embryos have Status as Potential Persons Some ethicists have a response to the foregoing objection to viewing embryos as persons. It is to concede that embryos do not currently exhibit these properties of personhood, but they will, if allowed to develop and fulfil their potential. To the extent that embryos are potential persons, it is argued, they ought to still be accorded the moral respect and dignity that personhood warrants. This potential person argument

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