Turning people into Numbers? Downsides and Possible Solutions to Clinical Research in a Global Context

Since the 1990s there has been rapid growth in the number of people participating in clinical research. Even though most clinical research is funded and controlled by more developed countries like the United States, the rise in human participants is primarily coming from developing low-income countries. There are a multitude of reasons why researchers are now going to low-income countries to find human subjects. Research guidelines may not be as strict, allowing researchers more freedom in conducting their studies. People may be more willing to partake in clinical trails because they are getting drugs they may not get under other circumstances. Lastly, the testing population in the United States has been gradually shrinking despite the increasing demand. Thus, compelling more researchers to adamantly search abroad from human participants (Petryna 185).

The United States drug testing pool has been shrinking since the 1970s. This was when the “use of prisoners as subjects was exposed and severely limited” (Petryna 185). Researchers had to turn directly to the American public to find human subjects since incarcerated individuals made up a large portion of their previous subject pool. The current issue at hand is slightly different. The US population has become a “treatment saturated” population (Petryna 185). Most individuals are on some sort of medication. Using medicalized individuals in clinical research could result in drug interactions and bias data. Some researchers have found a solution in using international individuals instead. Many individuals in less affluent countries have not had the same access and exposure to medications. This makes them naïve test subjects. This desire for the naïve subject is pushing American research initiatives abroad.

There are significant downsides to conducting medical researcher abroad. This current situation puts developed countries at risk for exploitation (Emanuel et al). In developed countries this risk is minimized because there is infrastructure that protects individuals. However, developing countries are less likely to have this framework in place, leaving individuals in these communities more susceptible. Ethical Variability by Adriana Petryna presents a good example. Researchers in developed countries usually target individuals in neighborhoods with easy access to hospitals and centralized healthcare. However, while searching for research participants abroad, many researchers seek out communities with broken health care systems. These areas are more likely to have more willing participants because the people there have no other access to healthcare. It is clear that the primary goal is getting as many subjects as quickly and cheaply as possible (Petryna 187). On a similar note, Petryna also discusses questionable clinical trials shortly after Chernobyl. She claims that chaos enabled researchers to perform trials they usually would not get permission to perform (Petryna 191). Even though some kind of attention was being directed toward the issue at hand, corners were likely cut and subjects were valued less as humans and more as unique testing opportunity. An element of humanity is definitely lost in this kind of approach.

Research projects themselves have become more about the numbers produced and less about the individuals themselves. This is a concern thoroughly discussed in When People Come First by Petryna and Biehl. Evidence Based Medicine, especially Randomized Controlled Trials, are now considered research standard (Petryna and Biehl 58). The issue is that these rigid research methods are not always applicable to the broad, complicated and unpredictable field of global health. Furthermore, studies resulting in defined measurements and statistical significance do not necessarily provide helpful conclusions or a useful platform for future initiatives (Petryna and Biehl 83). Recently, studies that actually aim to help individuals are often shut down because they will not produce the desired numerical results. Forcing determined NGOs to seek private funding if they want to implement effective projects.

When faced with such a problem, it is important to consider possible solutions. If companies desire to perform research beyond their own borders it is important that some regulatory system is established. As stated in the article What Makes Clinical Research in Developing Countries Ethical? such systems should prioritize participant protection. It should set guidelines to prevent researchers from taking advantage of research subjects. Another possible solution could be achieved through partnership. Although it was not completely perfect, the Leach and Fairhead article demonstrated a relatively effective solution: combining research and direct aid. Health workers provided new mothers with good health care and then performed research on the side (Leach and Fairhead 96). This approach allows beneficial research to done while still maintaining a humanistic element. If implemented correctly the motivation to perform research may even eventually foster more sustainable experimental and medical support systems.

Discussion questions:

  1. What do you think about the research performed after Chernobyl? Even if controversial research produces favorable results is still ethically acceptable? Should medical research guidelines be loosened in a state of emergency or crisis? Who would such an act benefit more: the researchers or the participating individuals?
  2. Not all countries have sustainable systems that can regulate medical research. Who should implement medical research regulations? What research guidelines would be essential in these scenarios?

Sources:

Petryna, Adriana. 2005. “Ethical Variability: Drug Development and the Globalization of Clinical Trials.” American Ethnologist 32(2): 183-197.

Biehl and Petryna. 2013. “Evidence Based Global Public Health.” When People Come First (Ch. 2).

Emanuel et al. 2004. “What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research.” Perspective.

Leach, Melissa and James Fairhead. 2011. “Being ‘with the Medical Research Council’: Infant Care and the Social Meanings of Cohort Membership in Gambia’s Plural Therapeutic Landscapes.” In Evidence, Ethos and Experiment: The Anthropology and History of Medical Research in Africa. P. Wenzel Geissler and Catherine Molyneux, eds. New York: Berghahn Books.

14 thoughts on “Turning people into Numbers? Downsides and Possible Solutions to Clinical Research in a Global Context”

  1. Hello Derana,

    Your post very effectively elucidates the problems inherent between targeting certain populations for clinical research. There is a very strong albeit unspoken power dynamic between researchers and participants when those conducting the research originate from developed countries and those partaking in it do not. You mentioned how researchers can be humanistic in their pursuit of research (i.e. by giving new mothers health care). While I agree with this, one should also acknowledge that this strategy might coerce mothers (who cannot afford health care through standard means) to participate in research that they would not willingly partake in otherwise. Also, they may do so without fully understanding (or trying to understand) the potential consequences of participation. That is, when given the promise of health care for themselves and their children, many mothers may not truly weigh the costs of study participation. In this way, similar strategies may actually take away the agency of participants.

    In the case of research performed after Chernobyl, I think that rules regulating the manner in which research is conducted should still be adhered to. The reason for such guidelines is to ensure that outcomes-based research is performed in a stable and safe manner. In the example you mentioned, this was clearly not the case as the Soviet Union’s decision (which was made in state of crisis) to approve of experimental therapies had the potential to harm those already suffering from nuclear fallout. For this reason, it seems that researchers (who can now conduct research with fewer impedances) are benefitted more than participating individuals.

    To combat the lack of regulatory agencies in certain countries, perhaps the responsibility to monitor medical research should be assigned to an international organization like the World Health Organization. Such an agency can be tasked with methodizing the manner in which research can be safely conducting, and a positive result of this can be limiting the variability in making clinical decision. Furthermore, a second alternative is for the general public to stay cognizant to research that is conducted in developing nations so as to ensure research collection is done with consent and with limited risk to study participants.

  2. Hi Derana,

    Thank you for your thoughts, I thought your post really underlined the problems associated with running a clinical trial in an area of the world where NGOs are also working to provide care. As I was reading for today, I found that the most complicated concept for me was the topic of consent. I wondered since there is such a power dynamic between researcher and subject, is there ever a situation in developing country research studies where the subject can truly give consent? How essential is it to keep in mind that some people may only be giving consent to get access to services?

    In response to your first question about Chernobyl, my first thought when I read about the experimental trials was that this could not be true. To jump from treatment in mice and rats in the lab to treatment in humans is quite a big leap. The argument that the people at Chernobyl really had no other options seemed like a lucky coincidence for the researchers. I believe that getting into a pattern of thinking that, because the situation is desperate, therefore the ethics of a study can be glossed over, is dangerous. Medical research guidelines should not be loosened in a state of emergency. If the intervention is successful, then that is a great achievement, but the risk of a trial going wrong would only compound the health problems a country faces. In a discipline that is based on testing hypothesis and understanding where an experiment went wrong, experimenting with someone’s life is too big of a risk. Loosening regulations would benefit the researcher at the extent of the participating individuals.

    In terms of enforcing these regulations, I think that this must done by an international medical research body, possibly through the WHO. If a team wants to go into a country to test a procedure, medication, study progression of a disease, etc, they must be held to the same standard as if they were conducting a trial in a developed country. This regulatory body would be responsible for regulation of the study, ensuring truly informed consent from the people in the study, and to underline that the main purpose for aid and trials in a country should be to help the people, not for gains in research.

  3. Hi Derana,

    Thanks for your post. I really liked how you addressed how American researchers are searching for more naïve test subjects in areas abroad where the subjects haven’t had the same access and exposure to medications. I also appreciated how you addressed the risk of exploitation. I agree too that using subjects abroad does put these developed countries at risk for exploitation.

    In response to your first question, I was shocked to hear about the experimental trials conducted at Chernobyl. I believe that the excuse the researchers provided for moving from experimenting of rats to humans is not justified in the slightest. These trials were extremely risky and clearly were performed for the researchers benefit rather than for the patient’s health. Due to this I don’t believe that medical research guidelines should be loosened in a state of emergency or crisis.

    For your second question, I think that it is the WHOs responsibility to implement medical research regulations. The WHO should be responsible for creating safe research standards and implementing the need for consent. They would create a standard for communication between the researchers and the subjects.

  4. Hi Derana,

    Thank you for your discussion regarding the issues that can arise between researchers and patient populations in developing countries. I think for the first question you pose, the only time medical guidelines should be flexible in a state of crisis is in certain time sensitive cases because other than those instances, guidelines are established to protect everyone in the research setting. I think that adhering or interpreting guidelines in large bureaucratic organizations can be difficult but it is an important element of research that needs to be monitored and followed. But I think when exceptions are made in a time of crisis and in time sensitive situations this would be more beneficial to the populations receiving the treatment as these considerations should be made with the sole motive of helping at risk populations quickly. These considerations should not be made lightly, and I think there may need to be a separate protocol when the treatment process is sped up to have the least damaging affects to populations being treated.

    The aspect of informing and gaining consent from populations is another issue that needs to be addressed in these cases. If there are certain guidelines bypassed for the sake of saving time, extra emphasis and resources need to go into the process of informing those involved in the study. Do you think that solutions to our earlier discussions in the semester about getting people to care more about global health statistics could be similar to getting these organizations look at people as more than just numbers in research projects?

    For your second question, I agree with the others who commented about involving an international institution like the WHO. I also think that in the countries where medical research organizations are from (if sufficient regulatory or health infrastructure exists) there should be some level of partnership between hospitals and these research organizations. This way, if hospitals in developed countries approve and help establish the guidelines used in lesser economically developed countries, the research organizations will be held to the same standard no matter where their work is being conducted.

  5. Hi Durana,

    Thank you so much for your thoughtful and insightful post. You raised a lot of good points and questions.

    To dive into your discussion questions:
    I think the first question is extremely difficult to answer. One of the major challenges of global medical research is that cases vary so much from one another, and it is hard to create general rules, regulations, and guidelines that can always create ethically acceptable studies and trials. I think that in some cases (as we saw last year with Ebola) it is necessary to loosen medical research guidelines to expedite processes. However, the idea of taking a drug that has only been proven effective in rats and then starting to use that in humans is terrifying to me–so I can’t answer this question very decisively. I honestly think that both the researchers and participating individuals have a lot to gain/lose from loosened guidelines. If the treatment works it is a success for both stakeholders–participants can have huge health gains, and pharmaceutical companies will have increased supporters, financial gains, and a good image. However, if the treatment fails, participants risk morbidity and mortality, while the pharmaceutical companies will suffer from poor image that can lead to loss in revenue and decreased supporters for the company. Because participants do take a life-or-death risk, I would say that they have more to lose; however, I do think that pharmaceutical companies risk a lot in conducting an expedited health intervention.

    I think that theoretically it would be great if international organizations such as the WHO regulated all medical research. However, I don’t think that any international agencies have the authority, power, legitimacy, and resources to do that at this point in time. I think that it would be important to include regulations on consent processes and cultural sensitivity to research guidelines.

    Thanks again for this post–you really challenged me to think hard about these questions!

    -Rebecca

  6. Derana –

    Your post brought up a lot of interesting ethical questions. Personally, in the context of crises I think there can be reason to hold different expectations for medical research, but these changes must be made in a way that holds the autonomy and rights of individuals at the highest standard. I think that if I were to be in a position similar to that of a victim of the Chernobyl accident, I would want to have options presented to me that may not be acceptable in other circumstances. That doesn’t however mean that we should be lowering the standards for medical ethics, but rather giving the patients a full range of options from which to make their own informed choices.

    Not all countries have sustainable systems that can regulate medical research. Who should implement medical research regulations? What research guidelines would be essential in these scenarios?

    In regards to your second question, although there are always problems with lack of enforcement and ineffective regulations, I think creating an international body focused on improving medical ethics is warranted and necessary. Such an organization could put out guidelines for medical trials, which could be enforced either by the country in which the study is being conducted (if that country has the resources to do so) or the home country of the company conducting the research. While this may not entirely fix the problem, and enforcement may become impossible, I think that it could be one way of mitigating the issue.

  7. Derana,
    I really like your post, especially the point you make about how an element of humanity can be lost when researchers and pharmaceutical companies look to foreign countries to test new drugs.
    It seems to me that clinical trial researchers are between a rock and a hard place. Without a doubt, all of the downsides to conducting research abroad that you mention are true. But we do need clinical trials to occur somewhere, so that safety and efficacy of new drugs can be proven. If Americans won’t consent to participating in a trial, then researchers may be forced to look for bodies elsewhere. But this isn’t perfect, either, since they might end up going to poor countries where people may “consent” to participate in a trial simply due to lack of any other care option. Maybe a potential solution would be to provide participating patients with the best possible care available (including general healthcare beyond the scope of the clinical trial). And–pertaining to your second question–I think an international body (such as the WHO) should be responsible for regulating such providing of care.

  8. Thank you, Derana and others, for sharing your thoughts.

    First, I would like to echo everyone’s point of appointing an international body, such as the WHO or the UN, to regulate medical research. Ideally, this would bypass the ethical concerns that are raised when investigators from a develop country conduct research on people in a developing country. This would work under the assumption that the appointed international body has the power and means to enforce the regulations they write. However, as Rebecca noted earlier and as we have discussed in class, international bodies today do not “have the teeth” to hold this responsibility. Thus, I wonder 1) how we could give international bodies greater agency to enact sustainable change and 2) if there would be any repercussions of granting them this agency.

    To come back to your first set of questions, Derana, even if controversial research does produce favorable results, I don’t think it is ethically acceptable to conduct the research because the risks would outweigh the benefits for the research participants. Meanwhile, the researchers would potentially only risk time and money – little when compared to losses of life. That being said, in a state of emergency, it may be necessary to loosen medical research guidelines to find a solution to the crisis quickly. In the best-case scenario, both the researchers and the participants would benefit from this potential risky research. More than likely, though, the researchers and a future population that is not comprised of the original participants would benefit, which would not abide by the ethical principles set forth by the Declaration of Helsinki. Consequently, it is imperative that we consider the means by which we are gaining the consent of research participants. Emergencies require quick thinking, so how will researchers know if the enrolled research participants truly made an informed decision?

  9. Hello Derana,

    I just wanted to quickly comment on the second question you asked. Setting international norms for ethics in research is tricky, as many comments have already suggested. They need to be flexible to account for cultural relativism. They need to be strict too to prevent pharmaceutical companies from taking advantage of vulnerable populations in developing countries. That said, I think there could be a body of the UN designated to setting norms, but I think there should also be anthropologically trained individuals regulating specific projects.

  10. Hi Derana!
    I really enjoyed your post as it brings up important issues that need to be addressed. I think that the research performed after Chernobyl was unethical. Dr. Reynolds mentioned this idea of ‘treatment naiveté’ (I believe that’s how you spell it), and how it is more beneficial to test people that have not been exposed to previous medications that could cause reactions/faltered tests. However, I mentioned this in Lilian’s post that I think this is “engineered consent:” consent without real consent. Researchers are not necessarily lying to individuals, but they need to understand that these people may not understand the full risks and dangers that they are exposing themselves to. I think that these tests may be necessary in the case of an emergency, but I still don’t think that this idea is ethical.
    Thomas Pogge defines this idea of creating a world that is fair because most people agree that if they could set up a world in which they had no idea where they would end up, they would create a fair world. Therefore, I think his point proves that in an emergency or crisis, these risky trials are not fair to the lives of the suffering no matter what.
    I think both the participants and the researchers should benefit. The researchers will hopefully find the data and cure to what they are looking for, and the participants will hopefully get the drug that they need. Unfortunately, I don’t think this happens very often.

  11. This idea of “turning people into numbers” is extremely powerful, particularly when we think about the aims of research organizations seeking to conduct studies in areas where local populations are desperate for medical resources and have nowhere else to turn. You articulated this wonderfully – “These areas are more likely to have more willing participants because the people there have no other access to healthcare. It is clear that the primary goal is getting as many subjects as quickly and cheaply as possible.” We manage to greatly exploit and reduce the suffering and importance of health to these individuals when we use their “population” and the bio-social ailments that threaten it as fodder for the mechanisms of knowledge production that we assign such great importance in our Western biomedically dominated culture of health and living, rather than allowing people to “come first” and having their personal goals for health, life, and healing dictate our conduct as a privileged and powerful body.

  12. Hi Derana,

    Your blog post is very informative and was very eye-opening. You highlight many of the issues regarding clinical research on a global context. As you mentioned in your post, the majority of individuals who participate in clinical trials currently come from low-income countries. While their incentive may be to gain access to medicines they may otherwise not have access to, another major issue I see in this is the idea of us versus them. Essentially, those running these trials are from developed countries with resources. They are testing individuals from resource-poor settings. As we have seen in many of the readings throughout the semester, the separation of us versus them can cause even further inequalities in global health. You mention in your post that citizens of developed countries are not ideal candidates for these trials because they are already exposed and prescribed to medicines, potentially causing issues in research. However, the ones they are more apt to test are those who do not have access to these other medicines. Should these organizations devote their funding to research on more medicines, or should they devote their spending to providing these individuals with medicines that those of developed nations already have access to?

  13. Hi Derana,
    Thank you for your thoughtful discussion on the complex problems involved with preventing the exploitation of developing populations in pharmaceutical trials. Since approval of drugs is so decentralized around the globe, with different nations and countries all having their own rules for pharmaceutical companies, it’s difficult to lobby one body or make one policy to affect change. Like many others have suggested, an international set of guidelines and subject use and treatment would be the ideal, but may also prove to be incredibly difficult to achieve.
    I think the best we can do for now is critically ensure the FDA is not allowing people in developed nations to gain off of the experimental bodies in developing nations, and provide foreign governments the help they need in fighting pharmaceutical interests to help patient populations. To talk specifically to your second question, I think breaching risk consent laws would need to carry a more serious punishment than they currently do. We’ve seen in our readings in class that pharmaceutical companies often do not take the time to ensure patients understand the risks of treatments and how physicians do not have the time to get proper consent, explain correct usage, and answer questions, ultimately harming the patient.

  14. Hi Derana,

    I really enjoyed your post! You brought up some of the key points that have to be taken into consideration when thinking about this topic, which is very complex. Additionally, I think your title “turning people into numbers” does a good job of addressing the dehumanizing nature that clinical research can take. While I by no means want to diminish the importance of clinical research, as without these studies there wouldn’t be the ability to develop life-saving technologies and medicines, I think it is important to think about it holistically and try to regulate it in a way that preserves the rights as well as humanness of the participants.

    To try to tackle your second question, which is incredibly complex, I think that the only way in which regulations will be truly effective is to have some sort of international body such as the WHO to come up with set of guidelines that apply to all countries. This however is very difficult to achieve because most international bodies have no real power but rather depend of the will of the governments in the respective countries, all of which have different rules and varying levels of regulation of clinical research. While I do not believe that this will be achieved in the immediate future I do think that there can be smaller steps taken to insure the rights of research participants in developing countries.

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