A Policy on the Use of Embryonic Stem Cells for Purposes of Research

Kris Broughton, Brianna Kujala, Eileen Searle, and Panot Sirisanthana

May 2003

Overview of the Technology

 

The focus of this executive summary is on stem cells and their applications and importance in human therapy.  Stem cells are unique to the body in that they have the potential to become almost any of the 220 cell types already present.  As these cells divide some of them will become specific cells whereas some of them will remain as stem cells, to continue in the process of reproducing and renewing tissues.  Stem cells derived from earlier fetal states are the ones used in most of this research, due to the fact that they are less differentiated than stem cells found elsewhere throughout the body.   

            Human stem cells can be derived from a variety of sources.  They can be derived through in vitro fertilization (IVF), either for the direct purpose of research or as a byproduct of a couple’s excess fertile eggs.  In vitro fertilization is the process of fertilization of a female’s eggs outside of the human body. Another source of stem cells is through introducing human adult nuclei into enucleated ovum.  These types of stem cells are embryonic stem (ES) cells and therefore have the potential to develop into almost any cell type.  Stem cells can also be derived from human fetal tissue, after the fetus has been aborted.  These types of stem cells are known as embryonic germ (EG) cells, which have similar abilities as the ES cells.

            Stem cells have various applications in the field of medicine.  Since they can develop into many types of tissues or cells, they have the potential to treat diseases that arise from impaired cells.  A current application of this technology can be seen in the treatment of Leukemia, via bone-marrow transfers.  The main importance of stem cells to the field is their ability to generate specialized tissues or cells that allow for the production of new cells.  These new cells can then be used to repair injuries and treat diseases.  Stem cells are also helpful in the development of new drugs, which could be life-saving and used to treat disorders. 

 

 

Ethical Issues in Embryonic Stem Cell Research

 

Ethical Issues Concerning Women’s Rights

 

            In order for the ethical debate about stem cell research to result in a fully informed decision, the issue of women’s rights must be considered.  Since a women’s body attains value to academic institutions and bio-technology corporations, the vulnerability of women’s eggs to commodification and exchange must be considered.  If women’s eggs are used for the development of embryos, and embryos constitute value, profit, and scientific research, then it follows that the reproductive rights of women, as well as women’s bodies, run the risk of being appropriated according to the demands of research and monetary value.  This debate is integral t the implementation of non-sexist embryonic stem cell research.

            This opens up an entirely different debate about the banning of embryonic stem cell research.  No longer does this place conservatives against liberals, or pro-life against pro-choice.  The question must be asked whether or not stem cell research places consumptive value on women.  In a July 2, 2001, Duke University news letter, Amy Laura Hall, an assistant professor of theological ethics, challenged the idea that the ethical debate about embryonic stem cells is an issue of pro-life versus pro-choice, arguing that it goes much deeper.  She argues that the debate must encompass feminist perspectives.  According to her analysis, stem cell research is equivalent to the harvesting of women’s bodies, and that its practice is perpetrated in the name of profit to private corporations.  Beyond adding a feminist critique of an issue central to women’s rights, what Hall adds to the debate is the ability to view the ethical quarrel through the limited pro-life/pro-choice argument of abortion.  She offers the ability to break down the complex stem cell argument into central issues of sexism and market value.

            One may argue, however, that the abailabilit of stem cell research as a viable, and likely option as a research tool is a product of the women’s rights movement, that it was creatd with women’s rights taken into consideration.  This is a widely presented stance of proponents of research.  The key to this debate is the negation of female objectivity in research practice.  In a letter co-written by the Society for Women’s Health Research, The American College of Obstetricians and Gynecologist, and the National Partnership for Women and Families to Massachusetts Senator Ted Kennedy, these groups argue that, “women’s health advocates have worked for years to overcome researchers’ past neglect of women’s health…in our pursuit for better information, treatment and cures for women and their families, we must ensure that the newest and most promising techniques are available to those same researchers.”  The debate on stem cell research must include the issues pertaining to the health of women an the perpetuation of a strong societal fight for women’s rights.  Because of this, the arguments of commodification and research potential must be weighed against each other.

 

Ethical Issues of Potential and Disease

 

            With the technology to research the potential of embryonic stem cells, in place, the ethical debate arises when considering the rights of those afflicted with a disease that could benefit from this research.  More specifically, how can research, supposedly committed to the improvement of human health, openly compromise it, perpetuating the suffering of patients?  At what point does the commitment to research stop, and is that stopping point in the best interest, ethically and physically, of the patients who receive treatment?

            The debate of this aspect of stem cell research is often over-simplified.  As the manifestation of research progress, it is this issue that is often used as a morality guage – researchers must have a moral obligation to protect the lives of suffering patients.  To negate the risk of simplification, this issue must be considered in regard to the commercial, moral, and legal arguments previously presented

            This in mind, Parkinson’s, a neurological disease, is caused by the death of millions of dopamine producing cells.  This is a fatal condition, slowly  affecting the motor skills and physical appearance of those who suffer.  However, undifferentiated embryonic stem cells offer great hope to this condition. Yet, this is only one disease for which embryonic stem cell research could prove advantageous.  Beyond Parkinson’s, kidney disease, liver failure, multiple sclerosis, and spinal cord injuries could potentially benefit.

            As these ethical issues are debated, time, a valuable commodity to suffering patients, passes.  Whether those with a potentially curable disease have an ethical right to this research depends upon two factors.  One, ethical appeals for or against stem cell lines may override this argument.  Also, the consideration of alternate methods of research may overshadow the benefits of one in relation to patients’ health.  A final policy decision on the research of embryonic stem cells will require a consensus on these ethical issues.

 

Problems with the Existing Cell Lines

 

As federal legislation stands in the United States today, researchers who use embryonic stem cells and wish to receive federal funding are limited to the use of stem cell lines established prior to August 9th, 2001.  It was on this date that President Bush set forth his policy that the cell lines already in existence came from embryos that were already destroyed and should not go to waste. However, the U.S. government would not fund laboratories that destroyed more embryos to create new lines.  While this policy seemed to be one that could satisfy the opposing sides on the issue problems have arisen.

Since the introduction of this policy several issues have arisen that point out its flaws.  The first of these issues is the lack of diversity in the existing cell lines. Certain diseases, such as sickle cell anemia, are more prevalent in particular races. If these races are not represented in the established cell lines then research into producing therapies for the diseases would not be done, thus putting certain groups of the population at a disadvantage in comparison with others. This could then lead to a new dichotomy between races.

Another problem with the existing cell lines is the manner in which they were grown. When the policy was established the cells were grown in mixtures with mouse tumor cells, called “feeder” cells, which secrete nutrients to help nourish the embryonic cells. There is however a well-founded fear that along with passing nutrients to the cells the feeder cells could also pass viruses or other microbes that could incorporate into the cells’ genomes and be passed through the line. Due to concerns over these risks the Food and Drug Administration (FDA) stated that it will demand extensive testing prior to human trials and long-term follow-ups of the initial human trials. While this problem was known before researchers were willing to cooperate, as this was the only known method for growing the cell lines. However, the technology now exists to grow human embryonic stem cells without mouse cells, making these lines more ideal for use in clinical trials.

 

Debates Over the Rights of an Embryo

 

Perhaps the largest controversy surrounding embryonic stem cell research, and what led to Bush banning federal funding for new cell lines, is that an embryo must be destroyed in order to establish a cell line. The debate is a philosophical, moral, and religious one. What is an embryo? Is it a person? A potential person? Nothing? Does it have a soul? Dr. Maurice Rickard presented a paper to the Australian parliament he stated, “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.” These embryos are potential people, but their destruction and subsequent research could yield potential cures for various diseases that could improve the lives of many. Which potential is more important?

There are no scientific answers to these questions. Scientists and politicians are faced with making the decision of whether we should destroy life to improve the quality of it or not. A key point is where the embryos are coming from and what would happen to them if they were not destroyed for research. As it stands today, most of the embryos in use were those that were “left over” from attempts at in vitro fertilization. After a couple conceives they decided to donate the embryos to research instead of freezing them or letting the embryo expire and be eliminated. As in vitro fertilization becomes more and more popular there are more and more embryos that are allowed to expire and are disposed of. Is this act of letting embryos die because they are not needed for implantation in a woman any better than intentionally destroying them. Some theorists and ethicists would say that letting an embryo (or any other entity) die is very different from actively partaking in its death, but then someone must remove the embryos from cold storage to allow them to expire.

Additionally some have looked beyond biological and medical benefits and drawbacks of research. There are several social impacts, on of which is the de-sensitization to the destruction of human life. Rickard mentioned this in his paper saying, “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.” He continues by commenting on the ‘slippery slope’ that introduction of research of this time could put us on.

However another theorist argues that embryos, whatever their moral status, cannot be harmed by their destruction:

Imagine that, just as Dr. Frankenstein reached for the lever that would bring life to the assemblage of body parts on his laboratory table, someone appalled at the experiment smashed the apparatus. That act, whatever we think of it, would not have been harmful or unfair to the assemblage, or against its interests.

With all of the debate over the rights of an embryo, and whether it is even a living entity that possesses rights one starts to wonder about other options.

            Do other options exist for conducting this potentially life-saving research? Yes, and these options have their own benefits and draw backs. The use of adult stem cells in research is possible and is being conducted in numerous labs. These cells possess the ability to differentiate into several different cell types (multipotent) but they cannot differentiate into any cell type (pluripotent) as embryonic cells can. Yet using these cells eliminates the debate over the destruction of embryos and has the added benefit that any tissues grown from it will be immunologically compatible with the person from whom the cell was taken.

            Another potential option is parthenogenesis, in which the eggs are never fertilized, but rather pricked with a needle and tricked into beginning development without being fertilized. However, this process leaves the developing embryo in a haploid state which leads to abnormal development and death. Yet technology is continually advancing because in 2001 parthenogenesis had not been undertaken in humans, yet Australian newspapers reported that it has been done with relative success recently. If a person gains his or her soul/personhood at conception and an embryo is created without fertilization then destruction of the embryo is not the destruction of a living entity, containing a soul.

 

Policy Regarding the Future of Embryonic Stem Cell Research

 

            Based on the above ethical and scientific issues, and many more that were not mentioned, we feel that a revision of the current Bush policy is in order. The lack of representation of minorities in the existing cell lines coupled with the recent advent of technology that allows for the lines to be kept without the feared consequences of "feeder" cells (tumor cells from mice) calls for the establishment of more diverse and pure (non-contact with tumor cells) lines. However, although these circumstances mediate the creation of new lines they do not do so without carefully constructed constraints.

            A new group of cell lines can be created ensuring that it is representative of all populations. The embryos used to begin these lines are to come from couples who give informed consent for the destruction of embryos left over from those created for in vitro fertilization. The creation of these new lines is to be mediated by a panel of scientists and ethicists established for this purpose and representative of all views from the scientific community which will fall under the jurisdiction of the Department of Health and Human Services. After the creation of the new group of cell lines federal funding will support only those laboratories that conduct research using cells from the appropriately established lines.  If in the future there emerges new reasons that might suggest the need for more, or newly established lines, is in order then again scientists must present their case to the panel who will determine whether it is a valid reason. Additional objectives of the panel will be to monitor the current research and assist in facilitating the sharing of information in the scientific community.