List of contents
Method and materials2
Arguments Against Stem Cell Research1
3.1 Interference with the Human Genome
3.2 Destruction of Human Embryos
Consequences of embryonic Stem Cell Research3
5.1 Current Regulatory Policies4
5.2 Policy Recommendations
6. Conclusion 5
7. Sources 6
Stem cells are primitive cells that are capable of multiplying and giving rise to more identical stem cells or specializing and forming specific cells of somatic tissues. There are two distinguishable types of stem cells: embryonic stem cells which can only be derived from preimplantation embryos and have been proven to be able to form cells of all tissues of the adult organism the other type of stem cells is adult stem cells, which are found in various tissues in the fetus and after birth and are usually more specialized with a vital function in tissue replacement and repair.
There are various sources of stem cells. In most cases these have been spare intro-vitro fertilization(IVF) embryos, although IVF embryos are been specifically created for the purpose of stem cell isolation. The most revolutionary option would be the creation of embryos specifically for the purpose of isolating stem cells through therapeutic cloning. This option is said to be the optimal medical use of embryotic stem cell technology since the nuclear DNA is derived from a somatic cell of a patient to receive the transplant, thereby reducing the chances of tissue rejection.
Why is this interesting
embryonic stem cell research is thought to have great potential in treating disorders in which loss of vital cells occurs. These include diabetes mellitus and Parkinson's disease. However, there are several moral concerns associated with this type of research.
The core issue related to embryonic stem cell research is the status of the pre-implanted embryo. Some people argue that the embryo is a human being with a soul that needs to be protected while others say that at that stage it is just a collection of cells that will not become part of humanity until a later time. It is impossible to solve this issue scientifically but the matter plays a rather central role in religious and political differences within America.
Another issue raised is that unlike in intro-vitro fertilization nuclear transfer will result in the creation of a "clone" of the donor of the adult cell. Implanting such a blastocyst into a woman would result in a child with the same exact genetic makeup of the donor of the nucleus. An agreement was reached prohibiting the reproductive cloning of humans as it is highly unethical.
Due to these ethical and moral dilemmas the government limits federal funding for embryonic stem cell research. Private sources and states have however, been left to determine the extent to which they are prepared to support additional embryonic stem cell research. The state of California, for example supports research in this area.
The aim of this research is to determine the causes of opposition against embryonic stem cell research and the current regulatory framework on the issue.
Why some people oppose embryonic stem cell research.
The main limitations of this research is the limited body of knowledge available on the issue due to the cost consideration of conducting research on embryonic stem cell research. Since it is still in its early stages, research on SCBPs is cost prohibitive to many countries and only developed countries can afford to fund the cost of research.
Method and Materials
Research Method: it will involve finding background information on what embryonic stem cell research entail and why it has become a concern in the last decade. The report will compile information from peer reviewed sources from governmental and medical associates.
Sources: in formulating an argument, several academic peer-reviewed databases will be used including ProQuest and PubMed which will give an overview of the body of knowledge available about stem cell research in the industry. A review of current sources will help to determine the case against stem cell research based on various factors such as financial cost, ethical considerations, and religious considerations.
Reliability: since the publications used in this paper have been extensively peer reviewed, they are very credible in terms of statistics, texts, data, and studies whose results affect the authors decision making. I deem PubMed and ProQuest as credible for research data as they have been formally recognized by all institutions of higher learning as an important research consultative guide.
Reasons Why People are Against Embryonic Stem Cell Research
Interference with the Human genome is similar to playing God
This view is based on religious paradigms that argue for the view that divine creation is perfect and humans should not alter it in any way. This perspective comes from the early evolutionary biologists who were greatly impressed by the evolutionary adaptation of species. Therefore, they tended to interchange perfect divine creations and perfect evolutionary creations. However, later studies on the molecular mechanisms of evolution revealed that animals and plants only have a limited number of strategies to achieve evolution. The molecular evolution of many organisms reveals that it is a matter of trial and error as there is no such thing as an evolutionary perfect creation.
The idea of humans playing God also implies the existence of information considered too dangerous for humankind to know. While this argument has few supports, most parties concerned in the issue agree that some things should not be done with stem cell considered as a method for producing treatments for human diseases. Therefore, as Marx states humanity is to be treated as an end in itself. There may be a moral obligation against creating human clones, but the Hippocratic oath taken by doctors gives no argument against using stem cell research to treat the sick.
Somatic Cell Nuclear Transfer is Immoral as it involves the creation of embryos only to destroy them during the stem-cell process.
Proponents of this argument base their arguments on the believe that stem cells can only come from embryos and thus ask researchers to consider the stage of development of the embryo and it associated moral rights. The issue of when an embryo acquires the rights of human beings has been a problem in both theological and philosophical issues for a long time with no clear consensus.
One condition that researchers use as a sufficient condition to confer interests and the associated right to defend them is sentience. In this context, sentience cannot be defined as the ability to think or feel pain but rather the ability to form links with the outside world. Until an organism develops a central nervous system and sense receptors, it cannot be considered sentient as it cannot form contacts with the outside world. With this reasoning, it is illogical to attribute sentience to a pre-implantation embryo until it is in the later stages of development having sense organs and a nervous system. This view is supported by the universal acceptance of the definition of death where death is regarded as having occurred once the central nervous system ceases to form contacts with the outside world.
The medieval church, on the other hand, is of the view that embryos acquire a soul when they became formatus and animates. This is when the fetus acquires a recognizable human form. Therefore, the abortion of an embryo that had not developed these features was only a finable offence while aborting after formatus was considered a mortal sin. The Catholic standpoint on embryonic research is based on a doctrine by Pope Pius IX who refused to countenance embryonic research on the basis that embryos acquire full human rights at fertilization. This view was effective at the time as stem-cell research was then based on somatic cells whose nuclei could be introduced into oocytes giving potential for the rise of a complete human being. However, recently, researchers in Japan and the United States successfully made skin cells behave like embryonic stem cells which might make the moral and ethical debate obsolete as applying the morality principle to all body cells is simply ridiculous.
Allowing Stem Cell Research May lead to Neo-Eugenics
In 1908, Francis Cornford explained the principle of the wedge as acting justly now for fear of raising expectations of the future that may lead to other expectations that one may not have the courage to satisfy (Corford, 1908). Using this reasoning, it involves the admission that one cannot always prove that an action is just and if they could, then that would be sufficient reason for not doing it. In addition to this philosophy, one can also consider the biological perspective in opposing reproductive cloning using cell nuclear transfer. This form of reproduction is only used only by lower animals and plants. Hamilton et al 1990 point out that primitive animals that have the capacity to adopt vegetative reproduction have consistently failed to do so. Sexual reproduction is genetically advantageous to human beings due to its evolutionary potential and the re-assortment of genes. In fact, the use of cloning can only be justified for farm animals where this technique allows them to acquire specific advantageous traits such as sheep resistant to Scrapie and cows resistant to BSE. UNESCO has attempted to resolve this risk factor through the Universal Declaration on the Human Genome that specifically prohibits the use of genetic manipulation to improve humans.
The use of stem cells as medicine is a promising research area as they can help the body to regenerate damaged or lost tissue in many diseases such as heart disease, Parkinsons, spinal cord damage, cancer, and multiple sclerosis. This is due to the cells ability to adapt to the hosts DNA to avoid rejection of new tissues. However, consistent arguments against stem cell therapy based on moral and biological grounds have merit in that they highlight the gaps that need consideration before widespread acceptance of SCBPs may occur.
Recognizing the risk factors involved in therapeutic use of stem-cells, the European Union and the United States have constructed a well-defined regulatory framework for stem-cell based product. Areas to consider when implementing these regulations include the product safety, stability, batch consistency, and product efficacy from the pre-clinical studies to clinical studies, and finally to market authorization.
The EU directives on stem-cell research and clinical use recognize that the conventional toxicology and pharmacology studies are different for cell based drugs. The EU regulation (1394/2007) of Advanced Therapy Medicinal Products, which was enacted in 2008, binds all member states of the EU. According to the directive, stem cell based products (SCBPs) intended for clinical use should undergo a strict and robust manufacturing process government by quality control procedures to ensure consistency in the final products.
In the U.S. the Code of Federal Regulations governs the use of cell therapy products. Biologics regulations (21 CFR 2000), cGMP (21 CFR 2011) and IND regulations (21 CFR 312). In these sections, SCBPs are classified into either 351 products or 361 products. 361 products involve the use of traditional bone marrow progenitor and blood cells as well as other tissues used in transplantation. The Food and Drug Administration categorizes 361 products under the Good Tissue Practice. These directives prevent the...
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