Into and thesis
Stem cell research is one of the most controversial topics amongst the scientific community to have gained importance over the last half a century. Research on stem cell-based treatments have shown promising outcomes in some cases for diseases that differ in the severity of health decay they cause. However, these studies have not fully understood or addressed the health risks that can arise from all the different procedures. Despite this, there has been an increase in clinics across Canada that offer stem cell-based treatments. This is due to a lack of a competent policy surrounding the use of stem cells. Canada’s vague policy and regulations related to the use of stem cell-based therapies has put the health of its patients at risk through the danger of false advertising its effectiveness and downplaying its risks. The policy needs to be updated to include specific regulations on the advertisement of stem cell treatments and these regulations need to be extended to cover all procedures that involve the research and use of stem cells in Canada to ensure all treatments conducted with stem cells are of high professional and ethical standards.
Method of data collection
The method through which the data for this essay was collected is multifold. The use of numerous sites and databases were used with some of them being gathered through traditional means for example, academic journals and e-books, while others being grey literature. The certainty that journals and e-books were up to academic standard was done by obtaining them through the York University library research guides web page, which offers a variety of databases that include information from academics who are researchers and publish verified findings within widely recognized academic journals. This allows for the use content from scholars and professionals in the health field. It offers literature that is peer-reviewed by academics and also includes their academic background information to ensure that the reader is well informed and certain that the published text is held to high standards. For instance, when using the e-book “Embryonic Stem Cells” by Elena Notarianni and Martin J. Evans, it states both authors to hold medical doctorates which gives credibility to their information and allows it to be included in the essay. The grey literature that was used was found on non-profit governmental websites, like the Canadian Institute of Health Research. It gave a brief overview of the history of stem cell research policy in Canada and included the email of ethics advisor Katelyn Landon who was contacted to provide me with detailed information of the former Canadian Institute of Health Research guidelines for stem cell research. This allowed me to compare how the guidelines have changed over the years to implement different regulations. Getting the information directly from the institute that created and implemented it gives confidence the information provided was accurate. There was very little difference between the first set of guidelines established in 2002 and the latest guidelines available which were established in 2010. The last methods of data collected was through media videos that displayed the process of cell differentiation and a website that explained the process of differentiation. Another website was used to depict the findings of a research done by two doctors on the formation of cancer cells, this study was edited and reviewed by these doctors which adds to its reliability.
History of the issue and approaches to rectify it
The first documented use of stem cells for the treatment of a patient was in 1950, when bone marrow transplantation was used to treat leukemia. As the use of stem cells was being further studied to implement in the health practice, the need for regulations came about. The involvement of the government for regulation in stem cell policies started in 1974, with the first major policy taking place in 1996 which addressed the use of federal funds for research of embryonic stem cells. This regulation bans the use of public tax money in the use of a human embryo for research purposes. The reason this policy came into effect is due to the method by which embryonic stem cells are gathered. The method is considered to be a form of murder by some. The process of collecting these cells terminates the pregnancy and stops the possibility of the life cycle to continue to grow and develop into what would otherwise become an infant. Research by Notarianni and Evans (2006) states that the zygote in a pregnant woman divides through mitosis to form a growing embryo, as it grows it forms a cluster of cells which are called blastocysts. There are embryonic stem cells inside the blastocysts and to get to them the blastocysts must be destroyed (pg. 239). These embryonic stem cells are the ones used in many stem cell research experiments because in the early stages of pregnancy (the first few weeks) they do not have specified functions yet and have the possibility to become any type of cell. This makes them easier to manipulate than adult stem cells because adult stem cells are thought to be limited in function with relation to only the organ they are derived from. A significant argument in relation to the ethical issues concerning this method of stem cell collection is that the blastocyst has the potential to become a human being and should have the same protection as every living individual, and not have that taken away from them before evening giving them the chance at life. This is the reason to why the procedure to gather embryonic stem cells is considered equivalent to murder by many individuals. Cohen (2007) mentions in her book Renewing the Stuff of Life: Stem Cells, Ethics, and Public Policy that “to destroy such early human embryos in the name of stem cell research is to throw the gift of life back into the face of the divine” (pg.88). Although this is an argument that some can relate to, many may argue that even though a blastocyst has all the genetic makings of a human, it has none of the characteristics of a person yet so should not be given the same protection rights as a human. Considering this debate, it would cause political complications if the money of taxpayers who do not support embryonic stem cell interventions went to fund it. Due to this divided thinking all stem cell research involving embryonic stem cells now have to be privately funded.
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Unlicensed clinics across Canada have been falsely advertising the effectiveness and downplaying risks of stem cell-based interventions for a variety of medical illnesses. These stem cell-based treatments have not gone through rigorous and extensive research that support their claims of curing or relieving the pain of diseases and are not approved by Health Canada, yet these clinics are still promoting them. Doing this poses great risks to patients who receive these treatments due to the lack of conclusive evidence in these treatments. Stem cells have the risk of uncontrollably multiplying causing harm and even have the possibility to turn cancerous. This is proven in the book Cancer Stem Cells: Novel Concepts and Prospects for Tumor Therapy by author B. Haendler when it is stated that “mutations in normal stem cells and failures of the control mechanism both play essential roles in the formation of cancer stem cells and in the development of tumors”. ( 2007,pg.4) An example of this is from a woman in Georgia who had gotten stem cells injected into her eyes in order to cure the problem of macular degeneration (an age related degeneration that results in blurry vision if not loss of vision), but the cells did not act as expected and grew uncontrollably which caused her eyes to become damaged and resulted in the loss of her sight, this is just one example of many such cases. The websites for these clinics offer a variety of treatments for a range of ailments like; autism, diabetes, asthma, erectile dysfunction and many more, but do not provide information on who will pay for these expensive procedures or their possible side effects. Since provincial health insurance plans and most private insurance, companies do not provide coverage for stem cell procedures, patients are left to pay for treatments that can cost thousands of dollars out of their own pockets. These clinics draw in tourists who come to Canada for the main purpose of getting stem cell-based treatments that are not offered in their own countries (“stem cell tourists”). For Canada to ban the clinics that perform these types of procedures would mean Canadians and tourists would not have the option to obtain questionable treatment in the first place. This claim is supported by authors Turner and Kimball in the book Medical Tourism: Risks and Controversies in the Global Market for Health Services when they state, “although this market enables patients to access medical services that might otherwise be unavailable to them, it also exposes individuals to risks they would not necessarily encounter in domestic health care facilities” (2012, pg. 253). A former method to rectify the ethical problem of murder was to stop the use of embryonic stem cells fully, but this limited the research possibility to completely understand the potential of stem cell treatments and the method was rejected. An approach to tackle stem cell tourists was a proposal to disclose the reason for tourists to enter Canada and deny entry if they stated they were coming solely for stem treatment. This proposal was discussed by policymakers, but Health Canada does not have a high level of jurisdiction or numerical evidence of tourists coming solely for the purpose of stem cell treatments for this proposal to take effect. It will also be hard to implement due to the fact that once people find out about this restriction, nothing will stop them from claiming they are coming for other reasons. Health Canada has sent out warnings to the majority of the clinics cautioning that they can be shut down if improper use of machinery or methods to treat patients are found, but these are the same for many other medical clinics and will not decrease the number of clinics in Canada. To prohibit the access to the operations of these clinics would demote people from trying to obtain them. Some approaches to rectify these problems are to educate Canadians and those who come to Canada to receive these treatments about the risks involved in having these procedures, and through specific regulation of what can be advertised for these clinics by forcing them to display all the risks involved, estimated costs, and include the fact that stem cell treatments are not concluded to relief illnesses, patients will know what they are getting in to. Laws need to be updated to include the use of stem cell-based treatments that come with dire consequences if they are followed. Many patients may be able to save their money, become aware of all the possible outcomes for their procedure and may even save their lives.
Policy and programming approaches
Prior to March 2002, there were no policies or laws in Canada pertaining to the use of stem cells for research or treatment purposes. The increased practice of stem cell research caused it to gain importance and to ensure ethical and professional procedures, the Canadian Institutes of Health Research (CHIR), combined with the Natural Sciences and Engineering Research Council and the Social Sciences and Humanities Research Council proposed guidelines for stem cell research. They state that research with stem cell is not allowed if it is not approved by the Stem Cell Oversight Committee (SCOC). The guidelines have a list of research methods that would and would not be allowed. Some methods that are allowed are that the embryos from which the stem cells were gathered have to be originally created for reproductive purposes, but are no longer required for that purpose. However, there have been cases of illegal stem cells being harvested for research from women who were paid for them. There must be informed consent from the persons that the stem cells are gathered from (both father and mother, or if donor used then from the donor, and if there is a single mother then from her). The sperm or ova that created the embryo from which the stem cells were gathered is needed to be volunteered and cannot be obtained through a monetary payment for them. The policy approaches outline methods of research that would not be allowed to be implemented in Canada, some examples of these are the creation of an embryo for the purpose of gathering stem cells from it, there can be no cloning of any cells even if gathered through methods that are allowed, and research that involves the donation of stem cells is not permitted, unless they come from the patient they are being injected into. This last example is important in particular because it is a significant reason for stem cell clinics to continue operations in Canada. By getting fat cells from their patient and then putting them through the process of differentiation for them to turn into specialized cells, finally, injecting them back into the patient typically in the same day (autologous donation). However, investigation of a select few clinics and patient testimony claim that the stem cells are not always retrieved from the person they are injected into and sometimes come from a donor match depending on the procedure being performed. Health Canada has shut down or given warnings to clinics that have done this. To be operating at professional standards clinics and researchers need to be working with high-quality stem cells, and that is only possible by submitting an application with the Stem Cell Oversight Committee (SCOC) that outlines the specifics on how the stem cells will be used, implemented, and discarded of. The application form found on Canadian Institute of Health Research website is named Sample consent information: Research Program to Derive Human Embryonic Stem Cell Lines from Cryopreserved Embryos and is set to ensure the when research is being conducted using stem cells the quality of stem cells is up to professional standards. This is done to confirm the legitimacy of all the results. Taking the significance of this into account, it is important to note that when patients go to stem cell clinics, the clinics do not have to use pure stem cells given by the SCOC, so what patients who use these clinics often get is fat tissue that is broken down and this does not comply with the health standards outlined by Health Canada. All research that is done with compliance to the guidelines set by Health Canada must offer health benefits to all Canadians rather than conducting research that applies only to a specific group.
Result of analysis
The result of the research is that although there has been many regulations and guidelines to address the scientific and ethical concerns of stem cell research over the years, they do not apply to the stem cell-based clinics in Canada that have been harming patients in many ways. This is due to vague and broad policies that clinics can get around without facing serious legal responsibility, the lack of specific policies enforced by law allows for unregulated stem cell research to take place and negatively effects patients and stem cell research as a whole. With false advertisement and unproven treatments, it gives patients false hope of bettering themselves which is not always the case. This claim is supported in the book Dreams and Due diligence by Till when it talks about how patients getting these treatments might not know they are not fully supported by research, and when they do not get the result that was assured they lose hope in recovering (2011, pg. 48). It can actually have an opposite effect, since it is understood that stem cell treatment can lead to the growth of unwanted cells that can cause harm to the patient’s health. Many documented cases show that doing an allogeneic hematopoietic stem cell transplant, a transplant that is advertised to treat many deadly illnesses can lead to growth of cancer when compared to patients who did not have this procedure done, a specific example of this is through a study done by doctor Gallagher Genevieve and doctor Donna L named Second solid cancers after allogeneic hematopoietic stem cell transplantation, which compared patients who have had the transplant procedure and those who have not to support the above statement. Many of these treatments cost thousands of dollars that are paid out of pockets of sick patients. If stem cell-based procedures continue to operate without the proper medical approval of Health Canada, they will continue to cause harm, which will destroy the credibility of stem cell-based research and negate it from being accepted as a form of treatment and may demote research in the stem cell field. Through controlled clinical trials, the study and establishment of stem cell therapies can be more reputable, as opposed to stem cell-based procedures done from the unofficial clinics. Health Canada needs better educate its citizens and those who come to get stem cell treatments in Canada on its effects and medical standings, and a review its current policy is needed to better control the new problem of stem cell-based clinics in Canada by extending its guidelines to include all procedures done using stem cells and enforce these guidelines through criminal punishment if they are not adhered to for the safety of patients who try to get these treatments.
Current policy and recommendations on how to improve the issue presented
The current policy for Canada on stem research allows stem cell clinics to operate offering medical interventions without the authorization of Health Canada. The technique of injecting stem cells for treatment is classified as being minimally invasive and Health Canada’s policy does not cover these treatments. The policy of Health Canada has not changed much since 2002 which did not have to deal with the problems of stem cell clinics that are seen in recent years. The policy should be updated to include the documentation of all stem cell therapies happening in Canada whether it be delivered through a minimally invasive method or not. There needs to be an update to the guidelines of today that include medical screenings of candidates for specific procedures in relation to specific illnesses to intensely study the detailed effects stem cell interventions has on each type of ailment. Only after these studies show promising results that are supported by academic institutions and medical experts should they be allowed to be used for treatment. In addition to the regulation of only using embryonic stem cells for that were originally meant for reproduction but are now not, there should be a limit to how many embryonic stem cells are available and distributed for research each year. This solves the problem of illegal embryonic stem cells being created for the purpose of research and supports the ethical problem with getting embryonic stem cells by limiting the number of embryos that are terminated. Another method to improve on this issue is to create a national registry of all embryonic stem cells created and used in Canada, it should include what procedures were used for what sickness and include the patient’s health background with results. This will help organize data from many different research experiments and should be available to all medical institutions taking part in stem cell research, which will help improve the quality of studies done by refining the methods or not using approaches that have repeatedly failed. Federal laws need to be put in place to prohibit the access to the operations of stem cell clinics until substantial evidence of the outcomes and risks of stem cell-based treatments are presented. Understanding that this does not happen overnight, it will also be beneficial to continuously educate Canadians and those who come to Canada to receive these treatments about the risks involved in having these procedures which can happen at a faster pace and demote people from trying to get these treatments. Through specific regulation of what can be advertised for these clinics by forcing them to display all the risks involved, estimated costs, and include the fact that stem cell treatments are not concluded to relief illnesses, patients will know what they are getting in to. Many patients may be able to save their money, become aware of all the possible outcomes for their procedure and may even save their lives. Adding these to the current policies will help improve the study of stem cell research and put an end to patients who receive treatments that are not concluded with heavy indisputable scientific evidence and only use proven and effective treatments to better the lives of those who seek the need of stem cell-based interventions.
- Cohen, C. B. (2007). Renewing the stuff of life: Stem cells, ethics, and public policy. Oxford: Oxford University Press.
- Till, James., Dreams and Due Diligence: Stem Cell Discovery and Legacy. (2011). University of Toronto Press.
- Gallagher, G., & Forrest, D. L. (2007, January 01). Second solid cancers after allogeneic hematopoietic stem cell transplantation. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/17131350
- Government of Canada, Canadian Institutes of Health Research, & Institute Affairs. (2018, October 03). Stem Cell Oversight Committee. Retrieved from http://www.cihr-irsc.gc.ca/e/19306.html
- Hodges, J. R., Turner, L., & Kimball, A. M. (2012). Risks and challenges in medical tourism: Understanding the global market for health services. Santa Barbara, CA: Praeger.
- Khanacademymedicine. (2015, March 27). Retrieved November 13, 2018, from https://www.youtube.com/watch?v=YtvL-LQlPrU
- Notarianni, E., & Evans, M. (2006). Embryonic stem cells: A practical approach. New York: Oxford University Press.
- Stem Cells. (2006, January 17). Retrieved from https://www.canada.ca/en/health-canada/services/science-research/emerging-technology/biotechnology/about-biotechnology/stem-cells-biotechnology-science-research.html
- Wiestler, O. D., Haendler, B., & Mumberg, D. (2014). Cancer Stem Cells Novel Concepts and Prospects for Tumor Therapy. Berlin: Springer Berlin.
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