A Framework for the Formulation of Guidelines Towards the Payment for the Donation of Eggs - Research Proposal Example

Missy Garza Mrs. Johanna Hunt Eng. Comp II 03.20.2009 STEM CELL RESEARCH AND OUR FUTURE Thesis ment Changes in US government policy on stem cellresearch have spawned a renewed outburst of activity in this area. The advent of more applications and newer techniques in creating embryonic stem cells has uncovered a new challenge, the shortage of eggs where embryonic stem cells originate and initially proliferate. This problem has been attributed to women’s hesitation to undergo egg donation, a process which does not pay for the eggs, unlike in the United Kingdom and other European Union countries. Recognizing the contribution of women and eggs to stem cell research, this paper proposes a framework for the formulation of guidelines towards the payment for the donation of eggs for embryonic stem cell production and research. Background Stem cells are naïve cells that have the capability of differentiating or developing into other types of cells in the body. Currently, many types of stem cells have been identified: embryonic, adult and induced pluripotent stem cells. Adult stem cells come from adult tissues like adipose, bone marrow, retina, muscle, heart; their main purpose is to repair and replace worn out tissues in which they were found. These cells are called multipotent because they can only differentiate into limited tissue types. Some adult stem cells can be induced to produce all types of tissues; these are called the induced pluripotent stem cells (iPS). Although the potential of these cells is quite high, studies are still underway to understand how they can be utilized fully (Webb). The most studied and with the most potential are the highly controversial embryonic stem cells. Embryonic stem cells have two extraordinary properties that make them very medically useful. First, they are "pluripotent," with the capacity to become any type of the 200 specialized cells in the body; a heart-muscle cell that pumps blood, a cell in the retina of that sees light, an acid-producing cell in the stomach, or a brain cell that stores memories. Second, embryonic stem cells can keep dividing and making unlimited copies of themselves; an important property, since huge numbers of new cells may be needed to replace cells lost to disease. Embryonic stem cells, because of their ability to regenerate different tissue types, are thought by most scientists and researchers to hold potential cures for Parkinson’s disease, diabetes, multiple sclerosis, cancer, spinal cord injuries, Alzheimers disease, heart disease, hundreds of rare immune system and genetic disorders, and many more. Over 100 million people suffer from diseases that eventually may be treated more effectively or even cured with embryonic stem cell therapy. Regenerative medicine is viewed to have the greatest potential for the relief of human suffering since the development of antibiotics. The embryonic stem cells are derived from 4-5 day old embryos (also called blastocysts), and the extraction of these stem cells lead to the destruction of the embryo. This is technically death, if life is accepted to be evident at 5 days after fertilization. Ethical issues on the use of these cells are based on the argument of what constitutes a human life and when an embryo is considered alive. These questions touch on the basic morality of humans, a morality tested with the potential benefits of stem cells to human health. Many people, including those suffering from diseases that this research is seeking to cure, do not believe in killing a living embryo in order to advance research and science. This moral dilemma may have prompted President George Bush in August 2001 to limit federal funding for stem cell research. In the US, more than anywhere else in the world, there were more limitations on the use of embryos and the types of research that can be performed.The NIH Human Embryonic Stem Cell Registry was created to provide a listing of federally approved Human Embryonic Stem Cell Lines http://escr.nih.gov that may be used for such research. This has not stopped private biotech companies from funding and conducting their own research, and creating their own stem cell lines. On March 9, 2009, US President Barack Obama signed Executive Order 13505 “Removing Barriers to Responsible Scientific Research Involving Human Stem Cells” (Federal Archives and Records Administration, USA), which in effect, revoked the President Bush’s 2001 order. EO 13505 expanded support human stem cell research to the extent permitted by law. Lately, the National Institutes of Health came up with draft guidelines which describe limitations of the funding. The guidelines also emphasized that embryos from which the embryonic stem cells are to be derived must be those that came from in-vitro fertilization (IVF) procedures and can no longer be used for that purpose. No limitations for sources were given for adult stem cells and induced pluripotent stem cells. Funding will not be granted to research which uses human embryonic stem cells from other sources, which include those coming from somatic cell nuclear transfer, and/or IVF embryos which were created solely for research purposes (National Institutes of Health, US Department of Health and Human Services). Main Proposal I propose to formulate guidelines towards a change in policy to the payment of egg donations. It is clear that there is a limitation on the source of embryos for embryonic stem cells, considering that there is a reported shortage of eggs for IVF; and consequently for embryo production. A new approach, therapeutic cloning, inserts adult DNA into egg cells to grow new stem cells that are not rejected by the source of the adult DNA. This patient- specific stem cell production requires many eggs for success. However, an egg shortage exists, which could be due to the small number of women who donate eggs for research purposes. Apparently, women are not paid when from donating for research, but are paid quite well when they donate eggs to fertility clinics (Bennett). This is in accordance with the practice followed in organ donation where the donor is not paid for his donation. However, this nonpayment has discouraged women from donating eggs, which is an arduous process. The egg shortage has impeded medical research, according to medical experts. Advocates of the nonpayment scheme say that paying for eggs will allow women to go into it for the money and will expose them to risks that would affect their health on the long-term. In the UK, women are being paid $250 for an egg donation, an amount which covers costs only for the procedure. Critics of this practice say that women should be paid much more for the donation because these eggs are considered prized commodities. In all these discussions, the involved sector of society, the women, do not appear to have a voice. Women’s groups in the UK and Europe have not proposed for any changes in policy, while government and private groups have not pushed for the same. For the women, they should be informed of the risks to their health, if any, and the benefits that can be derived from their donation. This should be a case for informed choice for those who wish to donate. It is ironic that the US is a country where abortion is legal, but the issue of paying for cells that can benefit millions of people is considered a “non-issue.” Considering the costs that patients are charged when they undergo stem cell transplantation, I think that it is only proper to pay for the eggs which are the main sources of embryonic stem cells. The stem cells derived from these can be multiplied continuously for a long time in culture, thus the benefits far outweigh the cost of the eggs. I propose that before guidelines are written down and submitted to the specific regulatory body, an information campaign through mass media must be conducted. This is similar to the campaign for organ donation, which can be read in the newspapers and advertised on television. This will create awareness of the issues and the potential benefits from the act of egg donation. After information dissemination, baseline information for writing the guidelines must be gathered. To do this, surveys (either by phone interviews or face-to-face interview) will be performed to assess what women know about stem cell research, its applications and the important role of women as egg donors. If they are not aware of these, then they will be provided the necessary information. After the baseline information has been gathered, then they will be asked what they think of the idea of being paid for eggs should they be in the situation of giving an egg for stem cell research. From this study, a draft proposal can be formulated which can be submitted to the US Congress for consideration for enactment into law. The egg payment scheme must be followed by each state, or it could depend on the state if they will give a law that egg donation must be paid. Most probably, stem cell research companies would prefer to pay for eggs, rather than face a shortage of eggs. Other non-monetary benefits can be offered the donors. Moreover, private and public funding can support the payment. The roles of public and private resources for basic research investments have been carefully conducted. After years of minimal federal funding that brought morale down and stalled basic research, the federal stimulus package has created excitement for the scientists, with a $21.5 billion investment in research and development. The National Institutes of Health is one of the major funders of biomedical research in the world. The NIH has allocated $240 million for embryonic stem cell research and $928 million for non-embryonic research since 2005, according to Forbes magazine. The NIH, for example, has distributed $200 million for challenge grants, $400 million for research comparing the effectiveness of treatments, $1.3 billion for construction and instruments, and $8 billion for other research. Some money will be steered towards the grant applicants who were recognized by reviewers but not funded because of budget constraints. Other funds will supplement existing work. The money will also support promising new work that could make progress with a two year grant. "Theres been almost nearly a decade now of fairly restricted funding at a time of rising opportunities," said Peter Sorger, a professor of systems biology at Harvard Medical School. "My guess is essentially every person who runs a lab will be contacting the NIH” (Johnson). Since its not yet clear exactly what projects will be funded, the inclusion of egg payments can be recommended. This is a small share in budget that is predicted to give very high returns. Conclusion The use of stem cells to form new tissues in regenerative medicine holds a lot of promise for curing many diseases. The significance of stem cell technology as led to the national policies that regulate research and application. However a very basic requirement, the source of eggs for embryos, appears to have been neglected, and due to this, the shortage of eggs could hamper research significantly. Since the nonpayment of egg donation appears to be a major reason for the hesitation of women in donating eggs, it is proposed here that guidelines and policy must be formulated that promote egg payment. Women and women advocacies should be actively involved in drafting the guidelines. Paying for the eggs, a very critical resource is but a small price to pay for the benefits that can be derived from the applications and the benefits of embryonic stem cells technology. Works Cited Bennett, D. "Egg shortages stalling stem cell research." Voice of San Diego 21 April 2009. Federal Archives and Records Administration, USA. "Executive Order 13505 of March 9, 2009." Federal Register. Vol. 74. 11 March 2009. 10667-10668. Johnson, C. "Scientists excited by the prospect of stimulus spending ." Boston globe 23 March 2009. "National Institutes of Health, US Department of Health and Human Services." 17 April 2009. Stem Cell Information. 20 April 2009 . Webb, S. "iPS technology gains momentum in drug discovery." Nature Reviews Drug Discovery 8 (2009): 263-264. Read More