Throughout its development in the past few years, controversy and debate have surrounded stem cell research.
Ethical and Safety Issues of Stem Cell-Based Therapy
Since skin cells have the capability to divide, our skin can heal itself through the division of cells. Scientists have attempted to apply this theory to major organs, trying to see if stem cells can be used to make the repairs that post-mitotic cells cannot. Stem Cell Research is a comprehensive and interesting introduction to this popular new science for students and non-experts.
Explaining how stems cells can be obtained from several places including skin, bone marrow, and most usefully, embryos, this book covers all the fundamental aspects of stem cell research in an easy-to-follow manner. There is consensus among scientists and bioethicists that generally the safest and most responsible route for approval of new treatments is the process of approved clinical trial protocols.
The experience of decades has shown the importance of this route, especially in the case of new drugs Meadows, , which includes first preclinical studies and then a sequence of clinical phases intended to test the safety and benefits of the new treatment known as phase I-II-III and IV. The rigorousness of this process includes scientific and ethical aspects The protocols must be approved by competent scientific and bioethical authorities.
This has meant a solid advance in medicine and patient protection, becoming the paradigm of clinical research. The path of innovation in Medicine. Beyond clinical trials. It is evident that not all medical progress has been made through the clinical trial model. This is a discussion that covers various areas of Medicine that has particular ethical dimensions Agich, Progress has also been achieved by medical innovation. The classic example is Surgery. There are numerous surgical procedures that were developed outside the clinical trail scheme for reasons of their own development.
Examples are laparoscopy and cardiac transplantation, among others Cosgrove, Something similar has happened in other areas of Medicine, especially in Pediatrics and Neonatology This route is not without risks James and Lanman, ;. Duc, There are treatments that have been incorporated into regular use in the clinic, however when they have undergone clinical trials they have lost their validity, due to the contribution of evidence-based Medicine.
Thus, medical doctors and patients should be aware of the uncertainties and risks involved in this course of action Mcculloch et al. The issue of medical innovation out of the process of clinical research regularly, is of special interest in the case of SC and highly controversial Hyun, ; Martell et al. Ethical research policy and ethics of caring for the sick. The purpose of clinical trials is to produce a general knowledge for the use of new treatments with proven effectiveness and safety.
The good of an individual patient is not the primary objective. In the case of innovative treatments that have not been tested by clinical research protocols, the perspective is different. They are covered by the field of ethics of the patient care aimed at the welfare of the individual patient. The ethics of clinical research does not have the same parameters as the ethics of the individual patient care. While there is always a risk versus benefit assessment, it requires a particular informed consent because the purpose is different. In an innovative treatment the goal is the good of the patient without knowing the outcome for certain.
This requires a particular form of informed consent to guarantee the security of the patients involved to be consistent with the intended purpose. The experimental treatment plan should be reviewed by qualified peers on scientific and ethical grounds. The results should be reported in scientific journals.
Fulfilling these conditions, as expressed by Lindvall and Hyun in , innovative treatment outside the framework of clinical trials may be acceptable from a scientific and ethical perspective. These treatments should be reserved for severely ill patients who have no good treatment options.
These patients are usually anxious and more interested in getting better and surviving than in expanding medical knowledge. They and their physicians should be clearly informed, given that SC will remain in the body and behave unpredictably.
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In order to warrant safety in innovative SC treatment more ethical considerations should be taken care of, such as clarifying the types of patients who qualify for them, maintaining adequate monitoring, taking into account the lack of evaluation of the placebo effect and giving consideration to the route for clinical trials if the gains are positive for a small group of patients Cohen and Cohen, b.
Although medical innovation in the treatment of patients has made significant progress, major disasters have also occurred in Medicine and Surgery in the past James and Lanman, ; Duc, ; Mello et al. The emergence of clinics worldwide that offer treatment with SC: The high expectations created by the potential therapeutic benefits of SC have had two interrelated effects. On the one hand, patients with severe or untreated diseases are eager to access SC treatment of diseases for which conventional treatment are ineffective Jawad et al. At the same time, there is an increasing number of unregulated clinics worldwide that offer SC treatment for various diseases Kiatpongsan and Sipp, As a result, patients suffering from untreatable or incurable diseases are the subject to unrealistic promises, unpredictable risks, misinformation, and eventual economic exploitation Taylor et al.
The stem cell tourism differs from the situation in which patients with serious illnesses, travel to qualified centers in other countries to get a better treatment or more experience. We agree with Mainil et al that a better alternative terminology for this latter procedure is "'transnational health care", understood as a 'context-controlled and coordinated network of health services", which is rather different from the concept of stem cell tourism.
The emergence of the stem cell tourism clinics has raised concerns among scientists and bioethicists who raise serious scientific and ethical issues underlying this situation about the prestige of SC research and patient safety Nelson, ; Gunter et al. In an article in Science reported there were nine research institutions around the world offering SC treatment for a range of very different diseases, mainly neurological disorders Parkinson's, Amyotrophic Lateral Sclerosis, Spinal Cord injuries, Autism, Depression , but the range included Myocardial Infarction, Diabetes, AIDS, Cancer and even infertility Enserink, The cost of these treatments was about U.
The number of patients being treated adds up to many thousands and with results that were, in some cases, dramatic, according to the clinics involved. In , Lau et al. The results showed that treatment offerings are varied and optimistically presented. However, there was no precise information on the types of SC used, their origin and how they were administered and there was no indication if these treatments had been evaluated by experts.
The information given to patients over the Internet was incomplete and could have raised public expectations without solid foundations. All clinics reported an improvement in treated patients, but without statistical support to evaluate the results. There was no clear mention of the risks.
The bioethics of stem cell research and therapy
Only a few clinics mentioned problems associated with the procedure. The authors warned that the overall results do not imply the clinical assessment of each individual, because there was no access to personal information received by patients or adverse or beneficial results. The number of these clinics is increasing Dolgin, ; Ryan et al. They are found in Russia, Santo Domingo, Barbados, China and India, where there are fewer regulations to control such treatments Pepper, But there are also clinics in countries with greater safeguards, like Holland and Germany.
In the mainstream print media, offers are presented optimistically, influencing the perceptions of patients Zarzeczny et al. China is the subject of special attention because of the high number of clinics and patients recruited. It is estimated that there are about laboratories dealing with SC techniques and at least three clinics that offer treatment. The lack of control over the quality of the treatments offered led the government to implement some regulations, which have been considered inadequate and poorly enforced Cyranoski, ; Nature Editorial, Cohen and Cohen a analyzed the situation in Russia and India, where there are similar situations.
The way to reach a large number of patients is primarily through the Internet. This avoids regulations in some countries that affect advertising media such as television and brochures.
Reports of problems with unregulated SC treatment corroborate the risks of these offers to patients and challenge the prestige of SC research and clinical use. For example, there is a report of a child in Moscow, Russia, with a brain tumor after being injected with fetal neural stem cells in the cerebrospinal fluid Amariglio, ; Macready, In Thailand a child developed a special form of tumor after a clinic injected autologous ASC to the kidney Thirabanjasak et al.
The situation described above has prompted the scientific community and bioethicists to seek regulatory criteria and requirements for information to protect patients and their relatives Cohen and Cohen, b. For this to be effective in an increasingly globalized and interconnected world, it is necessary that there be international agreements among nations Mason and Manzotti, , Schalev, Hyun et al.
In agreement with other researchers Lo and Parham, ; Lo et al. Given the novelty of the SC, they can have unpredictable behavior that must be considered by doctors and informed patients. The debate about regulation and patients' autonomy: This issue is still debated. The International Cellular Medicine Society ICMS is an organization formed by scientists, doctors and patient, with the aim of cooperating in informing and educating physicians and patients about the use of and advancement in SCs. The debate continues through open letters on the position by both institutions Audley, ; Sipp, Finally, we must consider the issue of doctors who use drugs that are experimental or that are used for treatments which they have not been approved for Okie, ; Radley et al.
This is a relatively common practice. However, it is essential to consider differences between SC and drugs. SC will live for a long time and can affect the patient with unexpected responses and changes depending on environmental signals and intrinsic properties Ginis and Rao, These clinics have defended their position and claim to follow the ISCM guidelines. An article in Nature in mentioned the lawsuit filed by the FDA against a clinic that was using SC for the orthopedic regeneration.
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Its medical director C. Centeno defended his position and reported his results in scientific journals Centeno et al. Some policies have been established concerning the information provided by SC clinics. According to these policies, there is arguably an ethical duty to provide potential clients of the clinics with the best available information about the risks and benefits of what is essentially an experimental treatment.
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