Emergence and Development of Stem Cell - Research Paper Example

Emergence and Development of Stem Cell Research 1. Introduction Conventionally, stem cell research has received much criticism and is regarded as controversial concept by many. These oppositions stemmed mainly from religious groups and then exaggerated by other political, cultural and other societal groups. The present topic studies various developments in stem cell research across the world in terms of regulations, patents and advancements. 2. Background: Stem cell research has received immense importance because of the potential of stem cells to improve and regulate a variety of body functions. Stem cells are those groups of undifferentiated cells which can generate specialized and differentiated cells and organs that have specific functions to perform (Potten & Loeffler, 1990). Two main sources of stem cells include embryos during early phase of embryonic development and adult stem cells. Interestingly, opposition to stem cell research is not uniform for embryonic and adult stem cells. Most of the regulations across the world are supportive of adult stem cell research, but varies hugely for embryonic stem cell research. For instance, in the United States, stem cell research on studies proposing to use animal sources of adult stem cells, embryonic stem cells or embryonic germ cell lines do not have any restrictions and are federally funded, unlike human embryonic stem cell (hESC) research (Downing, 2003) . 3.1. Emergence and development of stem cell research: In the US, many Christian groups protested President Bush’s initial decision regarding research on human embryonic stem cells, which resulted in forbidding further research on hESC research. Though this consoled the priests and other religious figures in the US, this decision also received much opposition from other religious groups within US and other parts of the world. Although religious groups expressed satisfaction over the President’s decision to withdraw support for research on hESCs, they also detested manipulation of existing stem cells for research purposes (Petersen, 2003). Research ethics concerned with ESCs are mostly about the method of deriving healthy human embryos and their moral status during early stages that carries different views in different religions (McLaren 2007). These differences have been the reasons for most of the ethical debate about ESC research. 3.2. Restrictions and limitations on stem cell research: After President Bush passed the bill on hESC research in 2001, funding restrictions were also imposed on this aspect as part of his campaign promise made to the citizens of the US that their money would not be used for stem cell research purposes (Stolberg, 2001). As a reaction to this, states like California, Connecticut, Illinois, Iowa, Maryland, Massachusetts, New Jersey and New York enacted independent funding systems (Frost & Sullivan, 2008). Regulations imposed on hESCs and adult stem cells are different in different countries. The policies on hESC research in the United States are more liberal, like that of Germany, Spain, France and Canada; but the policies in the United Kingdom, China, Japan and Israel are even more liberal than that of the United States (Herring, 2006). Evidences of amount of research indicate that adult stem cell trials have been more successful in most of the countries that encourage and support stem cell research. Outcomes of these researches on adult stem cells have been applied to treat many diseases, birth defects, cancers, severe heart related issues etc (Herring, 2006). These evidences only indicate the extent of advancement in adult stem cell research and application in various countries across the world. Patenting stem cells had emerged as a controversial topic since 1980s when the US Supreme Court declared that new forms of living organisms can be patented following Chakraborthy’s groundbreaking invention of new microorganisms created through genetic engineering (Smith, 2005; Soni et al, 2007). This debate also extended to embryos, whether created artificially or naturally, which largely affected granting patents to stem cell researches and products. In the U.S, patentability of inventions is determined by the US Patent and Trademark Office (USPTO), which along with the European Patent Office (EPO) and the Japanese Patent Office (JPO) is one of the predominant patent-granting organizations in the world (Genetics and Patenting, 2010). According to the U.S. law, stem cell patent is provided to the first inventor unlike other countries provide patent to the first to file the patent. The standard substantive legal requirements to stem cell related inventions include practical utility, written description, enablement, novelty, and non-obviousness (Spalding & Simkin, 2006). All the patent bodies only allow therapeutic cloning to harvest stem cells to be used to study human development and treat diseases. According to Bergman and Graff’s (2007) study on numbers of applications filed and patents granted, the US dominates stem cell research and patents; however, European contribution has been equally competitive in recent times. Although the US lead the number of patents issued till date, their strict regulations have reduced the impact and have also fostered competition from other countries. Other issues with such as huge costs and reliable public equity involved in stem cell research proposed by commercial organizations have also limited many other countries in advancement in this field. Most of the patents and work on stem cell research was earlier carried out by institutions such as the Wisconsin Alumni Research Foundation (WARF), John Hopkins University, Vanderbilt University in the US (Spalding & Simkin, 2006). European policy on stem cell research, especially on hESCs is very different. The EU Directive had earlier rejected all patents related to embryonic research because it allows for such research on whey industrial application is identified unlike that of the US which allows research for promising findings for betterment of health (Hermans, Loffler & Stern, 2008). However, the European Group on Ethics (EGE) puts strict restrictions on funding hESC research, both public and private researches, and does not support creation of embryos from somatic cell nuclear transfer for research purposes (Griessler, 2011). Stem cell researches on embryos as well as therapeutic cloning are legal in Belgium and Sweden (Solo and Pressberg, 2007). The Swiss regulation also supports ESC research. Somatic cell nuclear transfer is legally banned in France; research related to ESCs is prohibited in Ireland, Austria, Lithuania, Poland and Slovakia (Gottewis, Salter & Waldby, 2009). 3.3. Latest developments in Stem Cell Research: The latest governmental regulation in US on hESC research has revoked all previous limitations considering the immense advancement in the field and potential in providing treatment for many disabling diseases and conditions. The Executive Order (EO) issued by President Barack Obama (2009) declares support from federal and other agencies for human embryonic stem cell research with modified NIH guidelines for the same. The EO states that the Secretary of Health and Human Services, through the Director of NIH, may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell (hESC) research, to the extent permitted by law (2009; p.10667). Following this announcement by the US government, evidences also indicate that the British authorities have also announced their support towards hESC research extended to Advanced Cell Technology Inc (Moreno, 2011). 4. Conclusions: Based on this brief research and study, it is evident that the much talked about and promising stem cell research has advanced long way despite all controversies and limitations. Research that was initiated by private entities through private funding ultimately has shown some promising results, which have been recognized by government and regulatory bodies as useful for general mankind’s future and wellbeing. In addition, the commercial benefits have lured many private industries to invade this field. Based on previous progress, it can be believed that the revoking of regulatory and funding restrictions by the US and other governments would surely lead to greater advancements in this field in due course of time. These will also foster collaboration between different nations, provided the regulations of different nations are equally permissive to take on collaborated research activities. However, regulations must also put a check on commercialization of the process of procuring embryonic stem cells and their trials, which still remain issues to debate and concerns for most governments and research bodies. References Bergman, K and Graff, G.D. (2007). The global stem cell patent landscape: Implications for efficient technology transfer and commercial development. Nature Biotechnology. 25(4), pp: 419-424. Downing, G.J. (2003). A Researcher’s Guide to Federaly Funded Human Embryonic Stem Cell Research in the United States. In Chiu, A.Y and Rao, M.S (Eds.) Human embryonic stem cells. (pp:27-38). New Jersey: Humana Press. Executive Order 13505. (2009, March 11). Removing Barriers to Responsible Scientific Research Involving Human Stem Cells. Vol.74 (46): 10667-10668. Retrieved October 9, 2011 from, http://edocket.access.gpo.gov/2009/pdf/E9-5441.pdf Frost and Sullivan. 2008. U.S Stem cell market: Current developments. Myfrost.com Genetics and Patenting (2010). Human genome project information. Genomics.energy.gov. Modified July 07, 2010. Retrieved October 9, 2011 from http://www.ornl.gov/sci/techresources/Human_Genome/elsi/patents.shtml Gottweis, H., Salter, B. and Waldby, C. (2009) The Global Politics of Human Embryonic Stem Cell Science: Regenerative Medicine in Transition. London: Palgrave Griessler, E. (2011). Citizen Participation in EU Research Policies? The Debate on Human Embryonic Stem Cell Research Within the 6th Framework Programme. In robbins, P.T and Huzair, F (Eds.) Exploring Central and Eastern Europes Biotechnology Landscape. (37-54). London: Springer. Herring, M.Y. (2006). Genetic Engineering. Connecticut: Greenwood Publishing Group. Hermans, R, Loffler, A and Stern, S. Biotechnology. In Macher, J.T and Mowery, D.C’s (Eds.) Innovation in global industries: U.S. firms competing in a new world. (pp: 231-272). Washington D.C: National Academies Press. McLaren, A. 2007. A scientist’s view of the ethics of human embryonic stem cell research. Cell Stem Cell. 1(1), 23-26. Moreno, J.D. (2011, October 4). Britain Joins the Slog Through Stem Cell Vineyards. Science Progress. Retrieved October 9, 2011 from, http://scienceprogress.org/2011/10/britain-joins-the-slog-through-the-stem-cell-vineyards/ Potten, C.S and Loeffler, M. (1990). Stem cells: attributes, cycles, spirals, pitfalls and Uncertainties Lessons for and from the Crypt. Development 110, 1001-1020. Peterson, J.C. (2003). Is a human embryo a human being? In Waters, B and Cole-Turner, R’s (Eds.) God and the embryo: Religious voices on stem cells and cloning. (pp: 77-87).Washington DC: Georgetown University Press. Solo, P and Pressberg, G. (2007). The promise and politics of stem cell research. (pp: 101-110). USA: Greenwood Publishing Group. Soni, S.K, Soni, R and Goyal, N. (2007). Patenting biotechnological inventions. In Soni, S.K’s (Ed.) Microbes: A Source of Energy for 21st Century. (pp: 539-555). New Delhi: New India Publishing. Smith, G.P. (2005). Freedom of scientific investigation. In The Christian religion and biotechnology: a search for principled decision. (pp: 85-148).Netherlands: Springer. Spalding, T.N and Simkin, M.M. 2006. How will patents impact the commercialization of stem cell therapeutics? Life Sciences Industry Team. Foley and Lardner LLP. Retrieved October 9, 2011 from, http://www.foley.com/files/tbl_s31Publications/FileUpload137/3571/Stem%20Cell%20Therapeutics.pdf Stolberg, S.G. 2001. Bush endorses Limited Research on Stem Cells. Wright, J. (Ed.) The New York Times Almanac, 2002. New York: The Times. Read More