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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.
Dr. John Abramson’s book Overdosed America debunks the myths about the excellence of American medicine. Abramson backs up this claim by closely examining research about medicine, closely examining the unpublished details submitted by drug manufacturers to the FDA, and discovering that the unpublished data does not coincide with the claims made about the safety and effectiveness of commonly used medicines. Abramsons purpose is to point out the flaws of the pharmaceutical industry in order to warn the readers about the credibility of the drugs they are buying. Given the critical yet technical language of the book, Abramson is writing to an audience that may include academic physicians as well as those who want to learn about the corruption of the pharmaceutical industry.
Varmus , Harold, and David Satcher. "Ethical Complexities of Conducting Research in Developing Countries." New England Journal of Medicine. 337.14 1003-1005. Web. 9 Feb. 2014.
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
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...
Although, Marchant is a published writer it does not go into her background and what makes her a credible author in regards to placebos. She also discusses The Kaiser Foundation and does not even give us a brief description of how they are well informed in the matter. When you read an article and may not be informed on the subject matter, to build credibility, you should be able to explain your sources background to help build the credibility and strength of your writing. She mentions several studies and statistics but there is no credibility built to back up any of her sources; it’s written as it’s assumed they are credible. She ineffectively gave credibility to her sources, which makes you question the whole
3Walker, Hugh: Market Power and Price levels in the Ethical Drug Industry; Indiana University Press, 1971, P 25.
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.
There is not one concrete definition of a placebo. Placebos are fake medical treatments disguised as, for example, as a pill, a shot, ointments, or even fake surgery that is inactive and truly does nothing at all (Moerman). In the past, placebos such as sugar pills or vitamins were prescribed to please a patient requesting medication if the physician did not believe any real treatment was necessary. People in the medical community began to realize that patient’s symptoms were getting significantly better even when there was no chemical, biomedical or time-related reason. This changed physician’s belief that the improvement supposedly caused by a placebo pill was all in their patient’s head to believing that the patients min...
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
Reinarman, Craig and Peter D. A. Cohen and Hendrien L. Kaal. “The Limited Relevance of Drug
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
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 ...
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.
...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.