The heightened popularity of CCSVI treatments for MS patients is increasing in spite of the many ethical issues presented by it. As such, the Canadian government has a moral obligation to consider the implications brought on to Canadians seeking this treatment as well as the rest of its’ public. In this paper I will argue that due to increased media attention, multiple stakeholder desires, and different future health repercussions; the Canadian government needs to find some sort of regulatory measures to increase the ethical obligations warranted in such an experimental procedure while still maintaining the agency of its public.
The basis of the CCSVI procedure requires opening up blocked veins (McClure, 2011). The theory states that narrowed or blocked veins in the neck called stenosis will drain the blood that the brain needs and this turns into chronic cerebrospinal venous insufficiency (McClure, 2011). This condition is what has been claimed by Zamboni to cause symptoms of MS (McClure, 2011).
For those such as Linda Stewart who used experimental treatments unavailable in Canada who had a positive experience, the need for regulation is less supported (O’Connor, 2012). However, this does not mean that research should be negated. There are multiple recorded deaths of MS patients linked to the experimental CCSVI procedure (McClure, 2011). In one case, a woman who used the procedure came out with very high blood pressure (McClure, 2011). After she was dismissed with medication, symptoms of headache and nausea occurred (McClure, 2011). Not long after she was taken off life supporting machinery due to brain damage that could not be reversed (McClure, 2011). Her husband stated that these risks were never communicated to them bef...
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Sipp, D. (2010). “Hope Alone Is Not an Outcome: Why Regulations Makes Sense for the Global Stem Cell Industry” The American Journal of Bioethics. Volume 10. Issue 5.
Turner, L. (2012). “Beyond "Medical Tourism": Canadian Companies Marketing Medical Travel.” Globalization and Health. Volume 8. Issue 16.
Weeks, C. (2011). “An Uncertain Future Lies Ahead for Zamboni's MS Theory and its Potential Patients” The Globe and Mail. Retrieved from http://www.theglobeandmail.com/life/health-and-fitness/an-uncertain-future-lies-ahead-for-zambonis-ms-theory-and-its-potential-patients/article584981/.
Weeks, C. (2011). “Patients Flex Muscle in 'War' Over MS Treatment.” The Globe and Mail. Retrieved from http://www.theglobeandmail.com/life/health-and-fitness/patients-flex-muscle-in-war-over-ms-treatment/article579615/.
Scientists are on the brink of doing the unthinkable-replenishing the brains of people who have suffered strokes or head injuries to make them whole again. If that is not astonishing enough, they think they may be able to reverse paralysis. The door is at last open to lifting the terrifying sentence these disorders still decree-loss of physical function, cognitive skills, memory, and personality.
The author explains how randomized clinical trials put physicians in ethically intolerable positions of choosing between the good of the patient and that of society. A kantian argument is formed when the author explains how the physician has the duty to tell the truth and not use the patient as a mere means to satisfy the needs of a majority. The well being of the patient is far more important than that of the society when it comes to treatment by personal physician, the Author suggests that there should be alternatives to randomized clinical trials to deal with observer bias and patient selection. The overall message of the article stresses the importance of a patient’s well being over the well being of a society because the physician has the duty to help the patient improve his/her health.
Hypermobility: extreme joint mobility can be an indicator of this form of the disorder which may result o...
In the United States, the basis for ethical protection for human research subjects in clinical research trials are outlined by the Belmont Report developed in the late 1970’s. This document, published by the Nation Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, highlights three important basic principles that are to be considered when any clinical trial will involve human research subjects. They are; respect for persons, beneficence, and justice. (Chadwick & Gunn, 2004)
Multiple sclerosis (MS) is generally thought to be an autoimmune disease that attacks the myelin sheaths, or oligodendrocytes that cover nerve axons in the central nervous system (PubMed Health 2013). This immune response causes inflammation, which triggers immune cells to destroy axons “along any area of the brain, optic nerve, and spinal cord” (PubMed Health 2013). When the myelin sheath “is damaged, nerve signals slow down or stop” thus hindering the propagation of action potentials and limiting function (PubMed Health 2013).
Dr. Zamboni took interest in Multiple Sclerosis when his wife was diagnosed with the terrible disease. Dr. Zamboni did an experiment on a starter group of 65 patients. In the experiment he did a small operation that unblocked restricted blood flow to the brain. After two years, seventy-three percent of the patients had no symptoms of MS.
The Belmont Report distinguishes three center moral standards in regards to all human subject experimentation: autonomy, respect for persons, beneficence and justice. Autonomy alludes to the right of an individual to determine what they will or will not partake in. Respect for persons requires medical researchers to obtain informed consent from their subjects, which means that participants must be given precise information about their circumstances and treatment options so that they can decide what is best for them. Beneficence means that all test subjects must be informed about the advantages as well as all the possible risks of the treatment(s) they consent to participate in. The principle of justice includes individual and societal justice.
As Epstein (2007) alluded that pharmaceutical companies could be exploiting the poor infrastructure, deferential patient population and the lack of regulatory body in developing countries to conduct clinical trials that are ethically unacceptable [12].
The globalization of clinical trials is a fairly new phenomenon and the price of developing new drugs on average costs $1 billion and most of that cost stems from human clinical trials. In the “Ethical and Scientific Implications of the Globalization of Clinical Research” essay, the reason for outsourcing clinical trials to developing countries is the increasingly bureaucratic and expensive regulatory environment in many wealthy countries. Regulating clinical research have become very complex, placing a...
Multiple sclerosis is an immune mediated disease, although many researchers argue it is an autoimmune disease. MS causes the body to create an abnormal immune response to the Central Nervous System (CNS). The CNS is the body’s processing center. It consists of the brain, spinal cord and peripheral nerves. The axon of these nerve cells are coated with a myelin sheath, a fatty substance that surrounds the nerve endings. This sheath protects and insulates the axons allowing electrical impulses to pass freely from one nerve cell to the next. MS causes the body’s immune system to produce T-cells that pass from the bloodstream and into the central nervous system. The T-cells directly attack the nerve cells as if they were a foreign substance. They destroy the myelin coating around nerve fibers. When any part of the myelin is damaged scar tissue forms around the nerve ending. This demyelination and scaring causes lesions on the nerves. The lesions prevent impulses from traveling throughout the body and hinders the body’s response to afferent and efferent signals being sent to and from the brain.
Medical research involving human subjects is historically riddled with unethical experiments leading to harmful and even fatal consequences for participants. In order to avoid this in modern medical research, a system of medical ethics has been created. To properly review these standards for experimentation proposals, Institutional Review Boards (IRBs) were established in the United States. Although this system of ethics and review processes is tedious and difficult to appeal to, it is fundamental to ensuring the safety of all human participants consenting to medical research. Continuing medical research on human subjects, while conforming to the medical ethics and review processes deemed necessary by the government and the Internal Review
Much like the mirroring body of The Wounded Storyteller, when my mother was first diagnosed with MS she attempted to keep a facade of health by internalizing the pain associated with her condition and avoiding letting her loved ones see her in her new vulnerable state. In the months following her diagnosis, my mother did not seem, at least to me, to have readily apparent symptoms of her disease. She remained at work as a Registered Nurse, still saw friends for coffee, still bought groceries, and cooked dinner each night without appearing to even be phased by her illness. Silently and seemingly overnight, discussion of my mother’s condition seemed...
Monroe, Kristen, et al., eds. Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical and Political Issues. Los Angeles/Berkley: University of California Press, 2008. Print
The history of medical research in the twentieth century provides abundant evidence which shows how easy it is to exploit individuals, especially the sick, the weak, and the vulnerable, when the only moral guide for science is a naive utilitarian dedication to the greatest good for the greatest number. Locally administered internal review boards were thought to be a solution to the need for ethical safeguards to protect the human guinea pig. However, with problems surrounding informed consent, the differentiation between experimentation and treatment, and the new advances within medicine, internal review boards were found to be inadequate for the job. This led to the establishment of the National Bioethics Advisory Commission by President Bill Clinton in the hopes of setting clear ethical standards for human research.