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Ethics in biomedical research
Ethics in biomedical research
Ethical dilemmas in biomedical research
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The gold standard for a clinical trial design is the inclusion of a control. A control could be a placebo, active or no treatment. Clinicians use controls in order to give more power for their studies. A placebo control is a vehicle without the active ingredient. The main purpose of using a placebo in clinical trials is to differentiate the background noise from the actual effect of the treatment drug. Regulatory agencies prefer or favor trials that use controls such as placebo since the data obtained will be clear and non-ambiguous [1].
The use of placebo controlled study has been controversial since it was first introduced (c 1931). In this study, distilled water was used as a control when Sanocrysin was tested as a possible treatment for tuberculosis. The use of placebo control in clinical trials becomes controversial when there are other effective treatments available. It is undeniable that the use of placebo control can be beneficial in giving a strong clinically relevant data [2].
The recent version of the declaration of Helsinki states that “the benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention, except in the following circumstances [3]:
• The use of placebo, or no treatment, is acceptable in studies where no current proven intervention exists; or
• Where for compelling and scientifically sound methodological reasons the use of placebo is necessary to determine the efficacy or safety of an intervention and the patients who receive placebo or no treatment will not be subject to any risk of serious or irreversible harm. Extreme care must be taken to avoid abuse of this option.”
Clinicians, however, have been justifying the use of plac...
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... in clinical trials. This decision will benefit pharmaceutical companies and CROs since it allows them to use placebo control even when a standard treatment is available [10 & 11].
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].
This paper, by no means, is suggesting to completely avoid a placebo controlled studies. However, it points out that special care and thoughtful considerations need to be taken when planning a placebo controlled study especially where there are existing treatments. In addition, when conducting clinical trials in developing countries, patients should be given equal rights and opportunities as their counterparts in the developed countries.
Ethical violations committed on underprivileged populations first surfaced close to 50 years ago with the discovery of the Tuskegee project. The location, a small rural town in Arkansas, and the population, consisting of black males with syphilis, would become a startling example of research gone wrong. The participants of the study were denied the available treatment in order further the goal of the research, a clear violation of the Belmont Report principle of beneficence. This same problem faces researchers today who looking for an intervention in the vertical transmission of HIV in Africa, as there is an effective protocol in industrialized nations, yet they chose to use a placebo-contro...
In Marcia Angell’s article, “The Ethics of Clinical Research in the Third World,” she strongly argues the use of clinical placebo-controlled trials done in developing countries are unethical if an effective treatment already exists. Angell believes studies that compare potential new treatment with a placebo controlled group is ineffective and unnecessary. All research studies should offer the best standard of care and give participants the most beneficial outcome and treatment possible. The main priority of a study is not the goals of the research itself, but the well-being of the participants. Angell uses many sources to defend her argument, such as WHO.
It is the profits rather than the need of the world that drives the market, as Cahill points out. She laments that while in the 1960-1970 's theologic bioethicists influenced the field of bioethics, nowadays the ethical discourse involving Christian narrative gets" thinner and thinner," shifting away toward more secular and liberal views. As theologians are welcomed to partake in the ethical debates, their voices and opinions are rarely considered in policy making. Such situation causes the current trend amongst health care institutions,medical-surgical companies, and research labs, to focus on financial gain rather than ways to deliver health care to those who needed it the most. It is the consumers with the most "buying power" that have at their disposal the latest medical treatment, equipment, technologies, and medications while millions around the world lack the most basics of needs, such as clean water, food, shelter, education as well as the basic health care. Cahill fears that medical companies seeking profits will neglect or stop altogether to produce medications that are bringing low profits. Medications that are necessary to treat prevalent in the third- world countries or if you prefer the developing countries diseases, such as Dysentery, Cholera, Malaria, Rabies, Typhoid Fever, Yellow Fever, even warms, to name a
This systematic review conducted by Takeda A, Taylor SJC, Taylor RS, Khan F, Krum H, Underwood M, (2012) sourced twenty-five trials, and the overall number of people of the collective trials included was 5,942. Interventions were classified and assessed using the following headings.-
Ernst, E., & Resch, K. L. (1995). Concept of true and perceived placebo effects. British Medical
Article two entitled “Clinical trials: are they ethical?” is written by Eugene Passamani discusses the importance of randomized clinical trials. Passamani rejects the argument that the physician-patient relationship demands that physicians recommend ...
The placebo effect has been one of the most interesting but irritating topics within biomedical science for over the past 60 years. Through this speech I wish to inform and educate while I discuss the placebo effect and cover what it is, how it works and why that is.
With the high degree of variations in health care, patients can be under or over treated or even treated with the wrong treatment for their illness. These unwarranted care techniques can be categorized into three different situations. The first category of unwarranted care is the use of evidence or lack thereof, based on other medical care. The way to explain this category is that a care plan for a patient is proven effective without any proof as to why. The example given by Kongstvedt (2007) is the use of beta blockers post heart attack. Beta blockers prove to be effective in nearly one h...
3Walker, Hugh: Market Power and Price levels in the Ethical Drug Industry; Indiana University Press, 1971, P 25.
In the article “A Placebo Treatment for Pain” from Time magazine, Jo Marchant discusses How placebos are a great replacement for opioid pain killers. Marchant has provided plenty of examples of studies that support her thesis. Marchant effectively establishes pathos and logos with her readers by using vivid language and plenty of statistics, however, she leaves a lot of her statistical data and studies to be questioned through her lack of use with ethos. This need a transition.
Turner, B. J., Newschaffer, C. J., Zhang, D., Fanning, T., & Hauck, W. W. (1999). Translating clinical trial results into practice. Annals of Internal Medicine, 130(12), 979-986.
There are situations in which a seemingly unethical practice can be altered and used equitably. A pure placebo is an inert substance that can cause a real physiological effect. Impure placebos are unrelated and have active quantities, but non-related to the symptoms that need treating. Pure, and impure placebos can cause the placebo effect, which physicians can use to their advantage as long as there is no deception involved. Most important physician’s should never lie to a patient, or cause a nocebo effect by being negative. A physician can tell their patients about the placebo effect, and provide a supportive wholesome environment for their patients. If physicians do this they are following the current laws, and creating a open physician-patient relationship which allows for the most beneficial medical treatment for patients.
O'Brien, D. (2009). Randomized controlled trials (RCTs). In R. Mullner (Ed.), Encyclopedia of health services research. (pp. 1017-1021). Thousand Oaks, CA: SAGE Publications, Inc. doi: http://dx.doi.org.proxy1.ncu.edu/10.4135/9781412971942
An important part of an experiment is random assignment. If the participants for the study are randomly assigned to create two groups, and the researcher has enough participants in the study to have the desired “probabilistic equivalence” (Trochim & Donnelly, 2008, p. 187) then the researcher will feel a sense of confidence that the study will have internal validity in order to assess whether or not the treatment caused the outcome hypothesized. Well-c...
...per medical treatment. V.S. Ramachandran states that “randomized, controlled trial research do not make clinical decisions for physicians; rather, they must be applied to individual patients and clinical situations based on value judgments, both by physicians and patients. Clinical decision-making must entail value judgments about the costs and benefits of available treatments” (91). A patient can practice medicine by deciding whether a certain treatment option is right for him or her. For example, an individual might choose to take medication instead of having surgery because of monetary costs, or decide which prescription drug to take based on the potential side effects. Overall, though a physician may advise an individual on a certain treatment to cure him or her of a medical concern, it is ultimately the patients’ decision on whether or not to carry it out.