The Ethics of Clinical Research in the Third World by Marcia Angell

I have chosen to discuss the case of Terri Shiavo which was a very big ethical case back in 2005. She had been left on a ventilator for 15 years. So let’s start from the beginning. On February 25, 1990 Terri Schiavo had a cardiac arrest that was causes by extreme hypokalemia (low potassium) brought on by an eating disorder (Quill, 2005). As a result of this cardiac arrest Terri developed severe hypoxic – ischemic encephalopathy which is another way of saying lack of oxygen to the brain (Quill, 2005). During this period she exhibited no evidence of brain function and eventually scans of her brain showed severe atrophy of her cerebral hemispheres (Quill, 2005). Her electroencephalograms were fat, indicating no functional activity of the

For both of the cases presented, there were similar ethical principles that were violated. In both of the videos, confidentiality was violated. Both the Havasupai Indians and the infants had their blood and information associated with that blood viewed by many researchers who did not originally have consent to this information. The Havasupai Indians had the principles of beneficence and fairness violated. Beneficence was violated when no benefit was given to these people after they had agreed to take part in the study of diabetes that was affecting almost all of them. Fairness was violated when the researchers took advantage of the people not understanding what some of the things they were consenting to were. In the video with the infants, their fairness was violated

Due to the lack of money but the high demand of need of specific regimens in developing countries, researchers from developed countries are allowed to conduct trials on those citizens. In this article, Baruch Brody argues against moral criticisms given towards clinical trials in developing countries. His three arguments are the subjects weren’t treated unjustly (following an appropriate standard of justice), the subjects weren’t coerced (in terms of any plausible interpretation of the word), and the subjects weren’t being exploited (if they themselves gain access to the treatment after the study).

The Second ethical principle ignored by the research was withholding treatment for research purposes. The Medical Doctors withhold

Additionally human medical research studies often targeted those who came to public teaching institutions desperately seeking free medical treatment and who generally looked up to doctors and experimenters as experts in the field who were there to help them. While this motivation may seem logical, it is often faulty as many human medical research studies throughout history demonstrate that the motivation of medical researches is often not the care of those currently suffering from a particular condition but the future returns on the cures or medical treatments that may be discovered during the study (McKie). As with many such unethical studies, the participants often do not give consent and are not informed of known dangers to the procedure, medications or lack of treatment. The use of individuals who are poor, uneducated, and lack medical insurance in combination with prestigious university research institutions and the white coated, well-educated researchers motivated by discoveries of cures on the scientific frontier results in abuses of individuals.

In addition to not properly policing unethical research, the CDC also knowingly funds questionable studies. . It is important to note that the money the CDC puts towards controversial experimentation comes from American tax dollars. Marcia Angell M.D, the first woman to serve as editor-in-chief of the New England Journal of Medicine, describes an example of a CDC sponsored experiment that is very similar to the Tuskegee Experiment in her editorial, “The Ethics of Clinical Research in the Third World”. In 1997, the CDC sponsored a placebo test in third world countries to study HIV positive pregnant women. At the time, the drug zidovudine was known to be a successful means of preventing vertical transmission of HIV from infected mothers to their babies. However, the majority of the women in the study were denied antiretroviral treatment (Angell). Denying these pregnant women harms both the women and their babies. According to U.S. Sen. Carol Moseley Braun, because of this

Describe the ethical implications of the researchers’ actions and the lack of medical treatment given to research participants in both studies

A 35-year-old man named Paul, who has a supportive wife and two adventurous kids, has been diagnosed with a very severe case of bone cancer for 1 year now. Since this type of cancer is so severe, chemotherapy is starting to not work as well. Paul’s oncologist unfortunately had to suggest a final option for Paul to try which was a clinical research trial. Clinical research trials are experimental studies that deem whether or not a medical drug, treatment, surgery, or device is safe and beneficial for humans to use ("National Heart, Lung, and Blood Institute"). As explained in Marcia Angell’s Article, “The Ethics of Clinical Research in the Third World”, the Declaration of Helsinki of the World Health Organization (WHO) provides a guideline

Placebos have been used throughout many studies when testing experimental drugs for certain medical conditions. A placebo is a form of treatment that, in a sense, has nothing in it. Patients in clinical drug trials are often enrolled in the trial because many other treatment options have been tried and have failed. For terminal patients these trials are often their last hope of recovering from their diseases. According to Millum et al. (2013), “To be ethical, clinical research requires balancing rigorous science with the protection of human subjects”. It is common for placebos to only be effective in pain- related cases since pain is a mental state and placebos work on the mind. In other cases, patients are administered a placebo when the real medication is unavailable and deceived into thinking they have a chance at getting better. Many nursing professionals do not agree with placebos since often they are the ones administering and interacting with the patients they hope to help. Placebos are only justified in pain related trials, unethical to be used on terminally ill patients, and can potentially cause negative health effects.

Human beings were utilized as test subjects, enduring extreme suffering, merely serving as means to an end. The ethical misconduct was obvious; inclusion in clinical trials was associated with enormous risk and nominal benefits.2 As scientific research has evolved, more subtle manners of exploitation have become prevalent, and the direct or indirect exclusion of subjects places the same vulnerable populations at risk. Although the explicative methods are opposing, the outcome is the same. Vulnerable populations do not receive equal medical treatment. They are not given equal opportunities to experience the potential health benefits associated with research and therapy, placing them at higher medical

Nuremberg Code is a set of 10 sophisticate principles regarding ethical clinical research on human being (Grodin, 1994). It is mainly for protection of subjects’ human right (Shuster, 1997), such as compulsory of informed consent and the equal authority of subjects as the physician-researcher to end the experiment.

In conclusion, the purpose of the Code is to guide institutions and researchers in responsible research practice. The Code also promotes integrity in research and explains what is expected of researchers by the community. Therapists have ethical obligation to care for all patients with utmost care. The use of placebo has long been controversial, and the ethics of placebos have been debated frequently in history. When Hope used placebo group, it will only accumulate ethical concerns in her therapy and research procedures. Her placebo group will never get optimal treatment for their treatment is psychological and without actual effects on the condition being treated.

Although the solution to this problem might seem obvious, why would the proper officials not exhaust every alternative they have in combatting what the WHO considers to be a “public health emergency”? The answer is much more complex, with a multitude of ethical questions that linger. A few good points asked by ethicist are, “who would be the first in liune to get short-in-supply medications? “Who will make that decision”? “How do you communicate the risks of an experimental drug to a poorly educated inhabitant of a rural village”? And “would the money for these drugs be better spent on quarantine supplies and public education, to help prevent disease transmission”? All these questions bring into light and give a better perspective as to the possible consequences to administering such a drug could pose to the public. Considering the fact that those who have tried the drug have shown signs of recovery, have they really? With such a small sample (2 people) and not observing them over an adequate period of time, “the problem is you have no idea whether the medication worked or did not work” as mentioned by Dr. Ezekiel Emanuel, chair of the department of medical ethics and health policy at the University of Pennsylvania’s School of Medicine. A critical factor to consider also is that the people of African countries’ bodies will react differently than those living in the U.S their whole life. The small sample observed is simply not generalizable across a population and is low in external

Poor and/or inconclusive science: Many studies are being conducted and articles are also published in major medical journals every month regarding the evidence in order to provide patients with best available treatments, but none of them provide with useful and valuable clinical data, instead it gives misleading or wrong information which raises problems due to improper study design selection during research. Randomized, double-blind, placebo-controlled studies are considered as the “gold standard” of evidence for determining the cause and effect, whereas observational or epidemiologic studies, case series and reports provide the natural history of design. Although some of the well implemented studies may provide the conclusion only from one side of

Children with Human Immunodeficiency Virus (HIV) represent a notable number in this epidemic. Accounted for 400 everyday children became newly infected by HIV.1 Currently, almost 2 million children are affected by this virus. 1 This fact ignites scientists’ attention to do clinical trial to treat this population. In some literature, this research is even named with ‘cure research’.2,3 It may represent an optimism to the ultimate goals of the paediatric clinical trial where not only bring individual benefit but also societal benefit to the epidemic. Involving children in clinical trial has been claimed as children right and lead to benefits which are one of principal ethical called “beneficial’. Yet, the potential harm and risk are also being pointed out. This harm and risk will also violate children right to access the benefit research and their right to life, survival, development and health.