Clinical trials are crucial to discovering new medicines and
therapies for diseases that plague humanity.
The clinical trial process is very long, and often expensive. So, in order to speed up the process and/or
decrease costs, many pharmaceutical companies run the trials in developing
nations in Africa, Asia, and Latin America.
In 2013, all of the major pharmaceutical companies were present in
Africa alone (1). In 2015, about 40% of
the clinical trials were taking place in these developing countries (1). Trials in developing countries can be very
controversial. However, there are
certain places in the world where specific diseases are present. For
instance, there is a much higher prevalence of HIV/AIDs in Africa in comparison
to rest of the world (2). So, it would be
logical to have clinical trials located in countries where the majority of the disease
is located. With this in mind, there are
certain steps that the pharmaceutical companies must take in order to establish
an ethical clinical trial, even in Africa.
The National Institutes of Health (NIH), which is a research center and
an agent of the U.S. Department of Health, is not required to provide trial
participants compensation for treatment of research-related injury (2). Many people in Africa and developing
countries do not have access to health care, let alone insurance to pay for an
injury caused by a clinical trial. Although
there is not a requirement for compensation, many PIs in the research studies
provide medical care and treatment for the patients with a research related
injury (2). Not having adequate funding
for treatments is just one ethical concern of doing clinical trials in
developing nations.
References:
11. Puppalwar,
G., Mourya, M., Kadhe, G., & Mane, A. (2015). Conducting clinical trials in
emerging markets of sub-Saharan Africa: Review of guidelines and resources for
foreign sponsors. Open Access Journal of
Clinical Trials, 23. doi:10.2147/oajct.s77316
22. Mamotte,
N., Wassenaar, D., & Singh, N. (2013). Compensation for research-related
injury in NIH-sponsored HIV/AIDS clinical trails in Africa. Journal of Empirical Research on Human
Research Ethics, 8(1), 45-54. doi:10.1525/jer.2013.8.1.45
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ReplyDeleteThere are always reasons and justifications to why developed nations are able to commit the actions that are done. In this case, I understand the rationale about "certain places in the world where specific diseases are present", but when developing nations such as Africa, Asia, and Latin America have ALL major pharmaceutical companies present, it begins to raise eyebrows. It can begin to raise eyebrows, because how is it that the wealthiest pharmaceutical companies are congregated in specific, unstable areas? Is it because of coincidence? Maybe, but it begins to sound like exploitation to a certain degree. In many clinical trials health services are offered, but in most cases (especially in underdeveloped nations) the only way to access medical treatment is by participating in these clinical trials (Weigmann). So what ought to be done to avoid exploitation of disadvantaged areas? We have learned much about the bioethical values of non-maleficence, beneficence, autonomy, and justice. However, is it possible that some values out weigh others? I think that this paper by Katrin Weigmann will give some insight!
I recommend this paper because she explores what could be done to avoid exploitation of disadvantaged populations. It consists of informed consent, trials that address relevant diseases, and that the studies aim to deliver affordable drugs and care for the local population of that area.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4428044