Clinical Trials and Regimes of Research: Ethics, Progress, and Innovation

As we have seen continuously through our study of global health, healthcare provided by a foreign organization in a developing country affects and is affected by the local culture to a great extent. We have studied the necessity of expecting the unexpected when it comes to the possible consequences of our actions. We have learned about the ways in which cultural sensitivity and understanding have not been adopted in past interventions, thereby permanently changing perceptions of the West and sometimes negatively affecting communities an that intervention had intended to help. The readings about clinical trials in the global sphere, and the ways in which pharmaceutical companies have both benefited as well as manipulated populations in “drug-naïve” regions, are prime examples of these concepts.

Another theme we have considered in our readings and discussions has been losing sight of the people we are trying to help. Modern day methods of creating interventions rely mostly on numerical or statistical credibility, and it has caused many to ignore the humanity of the lives in question. Chapter two of When People Come First, entitled ‘Evidence-Based Global Public Health,’ illustrates the shortcomings of evidence-based medicine (EBM) and evidence based public health (EBPH) interventions. In the modern landscape of health interventions, lack of statistical evidence is equal to a lack of reliability in terms of the potential success or failure of a given intervention (Biehl and Petryna, 2013). Even so, without EBM, the safety of many treatments could not be determined with certainty. Though it could change the outlook and the questions asked, it is ultimately necessary for EBM work to be done to insure efficacy and safety. It is, however, also necessary to do qualitative studies that examine the greater social contexts and effects of interventions, and without those studies, we are missing vital pieces of information that could be used to better actuate change.

The readings all present a few reasons why global clinical trials and EBM are positive; however, they mostly discuss failures and problems with these recent developments in global health. Looking only at the three assigned readings, it is easy to become cynical about the involvement of pharmaceutical companies in global health, taking ethical advantage of needy populations for their own economic gain. In her article ‘Ethical Variability: Drug Development and the Globalization of Clinical Trials,’ Adriana Petryna talks about Chernobyl and the manner in which the crisis was taken advantage of politically, and subsequently scientifically. Those who wanted to experiment with therapies for the horrific damage that was caused by the nuclear accident were welcomed in by the Soviet Union’s leaders, casting all questions of the ethics of these studies aside in the name of aid. Petryna questions the ethics of these decisions made in times of crisis, and laments the variability in the reasoning behind them. While there are different reactions necessary to different crises, she argues that the underlying moral code of the regulation surrounding clinical trials should not allow for such variability (Petryna, 2005).

Today, though the FDA and other U.S. agencies cannot regulate trials in other countries, pressure from humanitarian organizations as well as the general public causes pharmaceutical companies to act in a less variable manner when performing research abroad. Clinical trials performed abroad also will not get the approval of the U.S. or other Western countries if done in a manner that is explicitly harmful. Of course, as the Leach and Fairhead article demonstrates, interventions or clinical trials can change the “therapeutic landscape” of a place forever. The ways in which people had previously experienced health and health care in Sukuta in the Gambia was permanently altered, shifting cultural paradigms and values. Though this particular intervention was mainly beneficial to the community, the consequences of it, and other similar projects, appear to be almost in the vein of colonialism—both invasive and patriarchal, insensitive to whatever structures or beliefs are already in place in a community.

Though there have been some sickening and disastrous outcomes from corporate involvement in global health—often from what is nominally humanitarian or philanthropic work—there have been many positive outcomes in recent years. During the Ebola epidemic this past year, many Western pharmaceutical companies jumped into action, quickly creating possible vaccines and launching animal and then human trials as fast as possible. What selfish motive could these companies have had in working to create vaccines for people at extremely high risk for a devastating disease? Yes, it would help their image, create positive PR, give people cause to stop hating “big pharma” as an impenetrable anathema, etc. However, these companies were at the forefronts of the effort because they had the money to back the research and the resources  ready to be mobilized for serious innovation. In their press release about the Ebola vaccine being tested, Johnson and Johnson lists organizations like Direct Relief International, Partners in Health, and other NGOs as organizations they are working with. Collaboration between the public and private sector is increasingly prevalent and is more successful than either one working without the other. While NGOs may have more expertise in countries of interest, pharmaceutical companies have the innovation and technology that is the basis of many interventions. The three vaccines shown in this image have all gone through Phase I clinical trials in Sierra Leone, Liberia, and Guinea, with mostly positive results. Can we really say that they took advantage of people in the developing world for completely selfish reasons when the outcome was not merely for their gain?

The vaccines currently being tested in communities with especially high risk for the rapid spread of Ebola. Image: 2015 Washington Post Article entitled 'How trials will work for Ebola vaccines'
The vaccines currently being tested in communities with especially high risk for the rapid spread of Ebola. Image:  2015 article by Berkowitz and Clark in the Washington Post, entitled ‘How trials will work for Ebola vaccines.’

A 2015 article in the Journal of Medical Ethics ‘Can Informed Consent to Research be Adapted to Risk?’ discusses the question of consent in different contexts, and how it can be improved to fit different research situations better.First and foremost, the article sets down the importance of consent: “Autonomy rights protect competent adults from unwanted interference and they also give them the opportunity to live their lives in accordance with their own interests, preferences and values” (Bromwich and Rid, 2014). The article states that as risk to participants in a study increases, the l consent of a patient becomes less meaningful. When performing studies, at home or abroad, language and literacy are a huge barrier between scientists and patients. As much as interventions and medications can be simplified, what details are being lost in this simplification? How can communication of risks and benefits be enhanced, and how can we ensure that these conversations are always clear on the part of the investigator as well as understood by the patient? Articles like this one are not uncommon in today’s medical and public health journals, and the way in which hulking industries and corporations, especially those coming from the West, are now treating issues like consent has become extremely visible. It seems to me that one of the more difficult issues in global clinical trials is no longer a question of blatant human rights violations, but rather more subtle consequences to the communities that participate in these trials. Though these consequences may often be unintended, at what point, in a world where cultural and anthropological knowledge is very available to those who trouble themselves to look, do these things become the result of calculated carelessness?

A qualitative study performed in Kenya in 2005, surrounding clinical trials for HIV/AIDS treatments, used focus groups to gain an in-depth understanding of the needs of participants. The study joins a large body of work on how to make clinical trials more beneficial to those who participate as well as reducing any potential long-term damage to communities. This, along with anthropological work like that of Biehl and Petryna, gives me hope for the future of clinical trials, so that, under the public eye, innovation will no longer come at the expense of vulnerable populations. However, many questions are still unanswered about the current state of medical research and the ethics and methods surrounding it. Scientists and companies that do not move forward in a humanistic way, considering the impacts of their actions down the road, may still do harm until more clearly agreed upon standards arrive.

Sources:

  1. Agnandji, S. T., et al. “Phase 1 Trials of rVSV Ebola Vaccine in Africa and Europe — Preliminary Report.” The New England Journal of Medicine (2015): n. pag. The New England Journal of Medicine. Web. 9 Nov. 2015.<http://www.nejm.org/doi/full/10.1056/NEJMoa1502924#t=abstract>.
  2. Berkowitz, Bonnie, and Patterson Clark. “How Trials Will Work for Ebola Vaccines.” The Washington Post. N.p., 8 Feb. 2015. Web. 9 Nov. 2015.<https://www.washingtonpost.com/apps/g/page/world/how-trials-will-work-for-ebola-vaccines/1594/>.
  3. Bromwich, Danielle, and Annette Rid. “Can Informed Consent to Research Be Adapted to Risk?” Journal of Medical Ethics 41 (2015): 521-28. Print.
  4. “Ebola vaccines, therapies, and diagnostics.” WHO. World Health Organization, 6 Oct. 2015. Web. 9 Nov. 2015.<http://www.who.int/medicines/emp_ebola_q_as/en/>.
  5. “Johnson & Johnson Announces Start of Clinical Trial of Ebola Vaccine Regimen in Sierra Leone.” Johnson and Johnson. Johnson & Johnson Services, 9 Oct. 2015. Web. 9 Nov. 2015. <http://www.jnj.com/news/all/johnson-johnson-announces-start-of-clinical-trial-of-ebola-vaccine-regimen-in-sierra-leone>.
  6. 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.
  7. Petryna, Adriana. 2005. “Ethical Variability: Drug Development and the Globalization of Clinical Trials.” American Ethnologist 32(2): 183-197.
  8. Petryna, Adriana, and João Biehl, eds. When People Come First. Princeton: Princeton UP, 2013. Print.
  9. Shaffer, D. N., et al. “Equitable Treatment for HIV/AIDS Clinical Trial Participants: A Focus Group Study of Patients, Clinician Researchers, and Administrators in Western Kenya.” Journal of Medical Ethics 32 (2006): 55-60.

Discussion Questions:

  • What is the best way to create ethical standards that apply worldwide for clinical trials? Or at least reduce the variability in ethical decisions? Is this even practical?
  • How can clinical trials be designed in a way that is beneficial to the health of populations in need, but not a cultural burden that follows in the footsteps of colonialism?

 

23 thoughts on “Clinical Trials and Regimes of Research: Ethics, Progress, and Innovation”

  1. Hello Zoe,

    You did a great job of presenting a balanced view of the currents benefits and issues associated with clinical trials and pharmaceutical research. I can understand why interventions by foreign agencies can be reminiscent of colonialism—as we have discussed many times in lecture and in section, NGOs and regulatory agencies are not wrong in their desire to help vulnerable populations. Still, in a historical context, I think many of the global health problems associated with underserved areas can be historically linked to colonialism and so the perception of targeted interventions as being patriarchal and invasive is justified. For this reason, I believe that EBM work is important to mitigate that harm these vulnerable groups can face if they are delivered ineffective and unsafe treatments but also agree that EBM and EBPH have several limitations.

    I appreciated your discussion of the power of partnerships between the public and private sector when performing clinical trials. As the reading by Zaidi from a few classes ago discusses, NGOs are limited in their reach because of reliance on donor funding, and the author asserts that reinvigorating the state should replace the current emphasis on NGOs. With regard to bettering these trials for pharmaceutical research, do you think that pharmaceutical companies aligning themselves with NGOs is the most effective strategy? In other words, do you think the same outcomes can be achieved if companies like Johnson and Johnson worked with the governments of Sierra Leone, Liberia, and Guinea?

    I think the best way to ensure compliance with global ethical standards in clinical testing is through legislation. Specifically, the World Health Organization can codify rules that reduce variability in decision-making. Still, as we have seen in previous readings throughout the semester, the WHO is limited in its capacity to enforce its regulations. As such, perhaps the only way to limit variability is for the public to continue putting pressure on pharmaceutical companies and for the Western countries to reject testing that is performed in a dubious or pernicious manner.

    Additionally, I think clinical trials need to be both inspected in a way similar to how companies performing internal and external auditing. Furthermore, patients should be surveyed and asked specific questions about how much agency they believe they have in making decisions for their health in these clinical trials. Only then can we ensure that the health of those in need is promoted.

    1. Hi Sachit,

      Thank you for your comment! I think that balance is very important when looking at issues in global health–they are often extremely nuanced and I think it’s dangerous to choose a side, cold and fast.

      In response to your question about partnerships between pharmaceutical companies and NGOs versus partnerships with the government, my only reservation about partnerships with just a government is a repeat of the situation with Chernobyl. The point of NGOs is to be an outside, unbiased, unpolitical actor, and the expectation is that they keep governments from acting immorally or not in the interest of the people–sort of a check on the government. Personally, I would feel more comfortable with the idea of having that check in place, as a go between between the corporate and government actors in an intervention, in order to protect the social and cultural interests of a people or place.
      I agree with your idea about legislation being the key to change, but like you said, the WHO has little to no power to enforce laws or suggestions that they create.

      Clinical trials are inspected as such, actually. A lot of work goes into measuring quality in every aspect of a persons life while on different pharmaceutical therapies and technologies. Qualitative analysis is becoming increasingly important to decisions about the effectiveness of different drugs, the text on drug inserts, and it also factors largely into the FDA’s decisions about passage of different medications.

      1. Hi Zoe,

        That’s a really fair point—in section, we talk a lot about how NGOs can be perceived as a form of foreign intrusion upon the issues of a developing country yet I agree with you that NGOs can serve as a check on governments. This begs the question of whether or not NGO involvement in developing countries is diminishing the agency of a government or simply preventing governments from overstepping their authority, and it makes the overall debate over NGOs all the more tricky.

        1. I think that’s a very valid point. For example in China, NGOs are often banned and seldom allowed to do work with minority populations. Would this be the case if the government felt no threat from NGOs? NGOs can certainly have a lot of power over the image of the government, and in societies where trust in the government is perceived to be the foundation of a functioning country, that can be extremely dangerous. However, that leads me back to the idea that NGOs can then be a good check on governments because governments that do not allow outsiders in to audit or intervene are slightly suspicious to me.

  2. Hi Zoe, thank you for your well thought-out post on regimes of research. I really appreciated your discussion on the issue of consent and the role anthropology can play to reduce the communication barrier between scientists that create drugs and the patient populations. I think this is the best way to answer the second question you pose. Strong levels of communication and awareness of regional history, language, and customs on the part of the NGO/researchers will increase the efficacy of the program and the relationship between the two parties. Because the clinical trials will be implemented by an organization that unfortunately has bureaucratic faults (issues of paper work, chain of command), I think that creating a standard for the ethical questions we consider during clinical trials would be very valuable. I think developing these ethical guidelines will be practical but difficult since there are many variables to consider such as different patient populations, countries, organizations, and the number of people working in the organizations. Formulating ethical guidelines would call for input from all of these actors and organizations.

    1. Hi Zelda,

      I agree that creating an ethical standard that can be adapted in a predetermined way to the different variables that arise in different places is extremely important to the future success of clinical trials (and by success, I mean not only the improvement and approval of a new drug or technology, but also the well-being of the community in which the trial is performed).

      The communication between the different actors in these trials, as you noted, is also very important. If the pharmaceutical company is acting in a vacuum, with no oversight or regulation from NGOs, governments, or concerned citizens, the outcome is much more likely to negatively affect a population. If an interdisciplinary team is involved in every step of the trial, ensuring that every possibility of unanticipated consequences and every aspect of the culture that could be affected by the intervention is considered, less and less damage will be done. Thank you for concisely synthesizing these ideas!

    2. Hi Zoe and Zelda,

      Zoe, thank you for your really thought-provoking post. This was a unit that I really grappled with this semester, since clinical trials dance on such a dangerous line of colonialist legacy and exploitation.

      Zelda, I agree with your point that developing exchanges of consent and using tools of anthropological reflexivity and focus on personal narrative can reduce some of the exploitative and colonialist valences of clinical trials, and can even increase the efficacy of their intervention-esque qualities. I agree that formulating a standard of ethics will not only be important but extremely difficult, given the countless factors that play into conducting respectful health interventions under organizations with historical and politico-economic privilege and power – hopefully, though, the importance of developing this standard will be enough to bring together the actors, organizations, and subjects you mention for meaningful and productive discussion.

  3. Hi Zoe

    Thanks for your post, it was extremely thoughtful and it is clear that you are really passionate about this issue. I really enjoyed you comments on pharmaceutical companies and their role with respect to Ebola. I agree that a lot of the work companies did during the Ebola crisis was not entirely selfish, and was mostly because they had the money to support the research and mobilize the resources. While, I agree that big pharma may not be all bad, I do not think we should ignore there were likely some selfish motives that drove their research, whether that be publicity or monetarily, if the next outbreak comes.

    I think that it might be nearly impossible to create ethical standards that can apply globally for clinical trials. In fact one argument that all of the readings made is that when clinical trials do not consider the cultural aspects of the communities they are working in, that is when the developing communities become negatively affected. As we have learned time and time again in the course, culture is such an important aspect to providing healthcare in developing communities. However, I think that one desperately needed approach to reducing the variability in ethics of clinical trials is to formulate a stronger definition for informed consent. Without such a definition, it is up to the research teams to determine what is true consent and what is not. With the desire to have large studies with high powered results, it can be easy to accept anyone who consents without considering his or her reason for consenting.

    Your second question is a really complicated one to which I do not have the answer. However, I think that the best way to conduct a clinical trial in a developing country is to follow a purely health based effort. NGOs and other global health organizations should first work with the community to set up an effective health system that provides high level healthcare to all people. By establishing a clinical trial in such a community, it could be possible to get better informed consent, because the people of the community would not see joining the study as a way to receive better health care. Additionally, by working alongside an established healthcare organization, there would not only be a high volume of patients that is ideal for studies, but members of the healthcare system could act as patient advocates. The best way to avoid an unethical situation is to not offer potential subjects access to care by joining a study that they otherwise would not receive. On a more global level, I think that an international organization needs to address the role of clinical trials in developing countries, but I struggle with how effective this could be given the limited power of the WHO.

    1. Hi Sarah,

      I do not think that it is a matter of good or bad for pharmaceutical companies in this day and age. As I said in a previous comment, this is an incredibly nuanced issue, one that does not conform to the labels of good vs. evil. Whether it is fortunate or unfortunate, at this point I am unsure, but health care in the United States in particular is extremely tied to our economy. It is inextricable, in fact. Pharmaceutical companies are, as we keep forgetting, businesses and so their ultimate goal is going to be making money. I do not know if we can actually label that as selfish behavior when that is the first function of corporations as they are defined. At the same time, I would like to know how exactly you believe a pharmaceutical company is going to benefit monetarily from developing a vaccine for a country in terrible need of any kind of protection against the threat of disease. There are so many different types of organizations involved in treating Ebola and preventing another outbreak at this point that there are too many eyes and ears out there for the news of an overpriced vaccine to not cause public outrage. So on that front, I do not think we need to be particularly worried. I do agree that of course this is good for publicity, but do not doubt that there are good people behind corporations as well that are doing things like developing vaccines because they know it is the right thing to do.

      I totally agree with your comments about consent. If you want to look more into the research that is being done on consent today, I would suggest looking of the Journal of Medical Ethics. There are many great articles on there that are about the most recent findings about how best to inform people so that they can make the right decision for themselves about whether or not they want to participate in a particular study. The study that I discussed in my post discusses the fact that the more risky an intervention, the less meaningful the consent. This is definitely an issue that we need to find ways to combat.

      1. Hi Zoe,
        I definitely agree with you that pharmaceutical companies are, in fact, companies first. At times it definitely seems like they are out to make the most money, and luckily the media is paying enough attention to call them out on it. Obviously it is unrealistic to expect pharmaceutical companies to provide medicines for free, but I think it is possible to negotiate lower prices for drugs that are desperately needed in developing countries. However, lower prices doesn’t have to mean that the pharmaceutical companies do not make a profit on that drug, it just means less profit. Additionally, pharmaceutical companies also make drugs that are not desperately needed abroad, and while I would hope their prices wound not be exorbitant, I think it would be preferable to have the drugs that are needed worldwide be cheaper in exchange. After taking this class, it upsets me that diseases we combatted decades ago in developed countries are still killing people in developing countries simply because not enough resources have been invested into fixing the problems. I would hope the humanity in everyone would be appalled by this as well, and people would be less inclined to make a profit and rather driven by wanting to help.

  4. Hi Zoe,

    Thanks for your post! I really appreciated your thoughtful comments on clinical trials and pharmaceutical research. I also think that loosing sight of the people we are trying to help is a major issue. Modern day methods do dehumanize the people we are trying to help, especially when we are relying mostly on stats and numerical credibility.

    In response to your first question, I don’t believe that there is a way to create ethical standards for clinical trails that can be applied across the globe. It would be extremely hard to create these standards when ethics in the first place are not uniform across the globe. What is ethical in some cultures may not be in others and I think that because of this variability it would be nearly impossible to create a standard.

    For your second question, I think that communication is a major factor in making sure that clinical trials are designed in a way that is beneficial to the health of the population. Communication between those creating the clinical trial, and the patients is key. This is especially true in terms of getting consent from the patients and community. If there is consent from the community, it is clear that the people of this community are partaking in the trial to benefit their health.

    1. Hi Sarah,

      Thank you for your comment! I think you are very right about the fact that ethics vary across the globe, and that that is maybe more important than creating some kind of standard. I guess the standard then needs to be place specific. Petryna’s article laments ethical variability, but in reality there needs to be some level of variability just so that the ethics of a particular place are being taken into account.

      I agree that consent is very important, however I do not think that just because people are giving consent does not mean that the trial will be beneficial to their health. If the trial is being appropriately and fully explained to the patients, and the trial is even testing something that has benefits to the patient, then it could definitely benefit them. However, some trials will have absolutely no effect on a person’s life (especially as a control subject that does not receive any treatment) or will even cause them harm (though hopefully not). When people engage in clinical trials having to do with drugs that treat serious diseases, they are often engaging in something that carries at least some type of risk, and so just by them consenting, it does make that risk go away or change the nature of the trial.

      You are very right about communication being important. Finding out the best way to explain a treatment to subjects so that they are comfortable, but also know the entire truth, is, to me, the only way to perform ethical trials. As I have noted in the other comments, there is now a lot of research on consent and how best to inform people in different places about what they are going to experience. Drug naïveté in a population can either cause people to trust in Western medicine too easily or to completely distrust it. Pharmaceutical companies and others performing interventions in these populations must be incredibly cautious about the effect that they have psychologically and culturally on the community they are working with.

  5. Hi Zoe,

    Thank you so much for this thoughtful response. Your post reflects a lot of the same thoughts I have been having about global medical research while doing these readings and throughout the entire semester.

    For your first question on how to create ethical standards that apply worldwide for clinical trials–I take the stance that this isn’t really practical. I think disease severity, cultures, and situational events vary so much that we can’t really make a one-fix-all set of guidelines that will always create ethical trials. In some circumstances, it may be more ethical for there to be rigorous and stringent guidelines in place for RCTs, and in others it might be more ethical to speed up the drug approval process and forego some of these guidelines in order to do so.

    I thought your discussion on how it is necessary for EBM work to be done to ensure efficacy and safety, but perhaps we could add qualitative studies that examine social contexts and effects of intervention into the mix. That way we would lose some of the insensitivity of humanity that can often occur in clinical trials as a result of dealing with numbers and statistics and not the human stories behind those numbers and statistics.

    Thanks again for this post–it was really well written!

    -Rebecca

    1. Hi Rebecca,

      Thank you for your comment! I am glad I brought up issues that you have been considering as well during the course of the semester.

      You are very right about the need for place-specific standards. The negative ethical variability that Petryna discusses in her article has much more to do with extreme cases, such as how pharmaceutical companies and governments act during a health crisis. To that end, I think it would be beneficial to set down some basic standards that just ensure human rights are never infringed upon. However, as Sachit brought up in his comment, standards agreed upon by the WHO, or other bodies of similar status, have a hard time enforcing those rules. So the question still remains!

      I completely agree about the addition of qualitative studies. In fact, qualitative studies, in the form of focus groups and interviews, are becoming more important in how pharmaceutical companies assess clinical trials. The interest in quality of healthcare in the United States has been on a rise in conjunction with the recent resurgence in the primary health care movement.

      1. Hi Zoe,

        I’m glad to hear that pharmaceutical companies are increasingly using qualitative assessments in clinical trials in the US. Are they doing this in other (specifically developing) countries as well?

        It is challenging that the WHO and other international organizations oftentimes don’t have much teeth to actually enforce the standards that they come up with as you mentioned in your comment. Do you think that there are ways to combat this? Should we focus on trying to improve the authority of these international institutions, or should we instead leave it up to national governments and try to create these basic standards on a country-by-country basis.

        Thanks,
        Rebecca

  6. Zoe –

    Great job weighing the various benefits and harms of EBM. I especially appreciate your comment about integrating qualitative research into the field of medical research, as I think that this is an area where common ground can be found between the two arguments. I too believe that on the whole EBM is beneficial, and within the proper contexts it can have incredible results, however on occasion, such as in the Nepalese project example, it can have the opposite effect. I think accepting qualitative research as an acceptable form of knowledge production for public health interventions is one step we can take towards eliminating some of the over-burdening of EBM that can interfere with the good done by interventions.

    One way I think we can ensure high ethical standards in pharmaceutical research conducted in developing countries (and I might be proposing something that’s already done/totally infeasible/absolutely ridiculous, I’m not particularly familiar with this topic), is for the FDA to prohibit the sale of drugs that were tested in a manner that doesn’t meet the ethical standards that would have been enforced had they been tested in the US. While this won’t make a difference for drugs that aren’t used in the US (like drugs for many infectious diseases that don’t affect the US population), I see potential for reduction in less than ethical research practices for many drugs.

    1. Hi Ruby,

      Thank you for your comment. You are right about the integration of qualitative research into EBM being a good compromise for both extremes.

      In terms of your ideas about ethical standards in pharmaceutical research, your proposed solution is actually already in practice! The FDA of course prohibits the sale of drugs that were tested in a way that does not meet their ethical standards. Their system is called Good Clinical Practice, and when a drug is being developed and going through trials, part of the FDA’s review of the treatment includes audits of the manner in which it was tested. They have the right to dig as deeply as they want into the methods of the scientists doing the testing. These standards are for ANY drug that a company may want to market in the US, whether the trials were done here or elsewhere. Though they do look at the studies during the approval process, the FDA is a regulatory body that has control over what gets legally sold in the United States, not over the actual performance of studies. So then the problem may not lie in how the sale of drugs or the approval of drugs for the U.S. market is regulated… it is more in the case of a crisis abroad (like Chernobyl or Ebola) that we are worried about ethical variability. In times of crisis, how can we ensure that people are treated humanely? In fact, what would treating people humanely entail? Does it include trying any treatment because the situation is so desperate? Even one that could make the condition worse? It is these issues, which lie outside the jurisdiction of the FDA, that I am concerned with.

      If you want to read more about how the FDA operates in terms of the approval of drugs after clinical trials in the US or elsewhere, here are a few links for you to check out:

      Premarket Approval of trials for Medical Devices
      http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/ucm050419.htm#research

      Clinical Trials and Human Subject Protection
      http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/

  7. Hi Zoe,
    I really enjoyed your post—and I particularly like that you address the necessity of EBM—even though EBM experiments in foreign communities may be manipulative and/or harmful, it is important to prove, with certainty, the efficacy and safety of a new treatment or drug. I suppose the ideal solution would be to figure out a way to conduct scientifically sound trials while minimizing harm and without taking advantage of bodies. Maybe members of research teams need to be more trained in anthropology and cultural understanding in order to reach that goal. As you say, collaboration is important in order to maximize breadth of knowledge.
    Regarding your first question, I think that it is practical to design standards for studies worldwide, and I think an existing international body, such as the WHO, is in a position to do so. I think standards should be created by a close review of the outcomes (and unanticipated consequences) of past clinical trials. Focus groups, such as those in the Kenya HIV/AIDS study you cite, are a great place to start, so that participants’ needs, preferences, cultures, and desires could be understood.

    1. Thank you for your comment, Lindsay.

      Yes, collaboration, almost certainly, is the key to success. No one person (not even a few people really) can hold enough collective knowledge to integrate the experiences, culture, and history of a place into a medical or scientific endeavor there. The interdisciplinary approach to health is always important, but in the case of global medical research it is especially necessary because it allows for many checks on the possibility of human rights abuses or even just the minor negative effects of an intervention.

      I appreciate your optimism towards the creation of international standards. Most of the others who have commented on this post have felt that there is too much of a need to be sensitive to different places and cultures to be able to, but I think that your point is a good one. Studies like the one in Kenya are a great jumping off point. Conversations like that one need to be started all over the world, and the Declaration of Helsinki needs to be given new life and broadcast again. I am still unsure of how something like that can be enforced though…

  8. Thank you, Zoe, for stirring up discussion about the limitations of our modern-day research methods and also the necessity of combining qualitative and quantitative means.

    To address your first question, I would like to highlight the theme of cultural competency that is most evident in the comments posted by Sarah, Rebecca, and Lindsay. Before deciding whether or not some governing body, such as the WHO, should create international ethical standards for clinical trials, this body should consider the implications of said standards. These standards would inevitably serve as a kind of blanket statement for all countries, which may be beneficial because participants across the globe would be protected from exploitation but may also be detrimental because disease severity, cultural influences, and situational events among other factors vary from country to country (and even from community to community). Since I do believe that we should create international ethical standards for clinical trials, it is important to address this fine line that these standards would treat, and also see communication as a potential solution.

    As you and Zelda stated, enhancing communication between researchers and participants is a key component of improving international research studies. Researchers would fully explain the purpose, risks, and benefits of the study, and the participants would understand and thus make a fully informed decision. Although this is a little too optimistic, clear communication would allow for there to be the collaboration of disciplines that Lindsay alluded to. Moreover, this communication would be helpful in the design stage of clinical trials to ensure that researchers are doing as much as they can to benefit their research population and minimizing the risks. To answer your second question more definitely, I’m not sure if there are exact procedures (aside from becoming knowledgeable in their community’s realities, history, and needs) that researchers can follow to actively avoid the paternalistic mindset.

    1. Hi Natalie,
      Thank you for your comment. I completely agree with you about the need to consider the implications of whatever standards are put in place. As we have learned, unanticipated consequences will almost always occur, and it is our duty to try and mitigate them as best we can.

      I really like the way you discussed communication as a solution to the ethical issues with clinical trials. You stated some of the ways in which communication could improve everything from consent to minimizing risk and maximizing benefit for the participants.

  9. Hi Zoe,

    You did a great job of giving a comprehensive analysis of ethics in global health research. I agree with many previous comments that it would be very difficult to create an international set of ethical norms for research, given the social, political, and cultural differences in populations. I would say, though, that because it is both important to limit ethical variability, yet account for cultural differences, it is extremely valuable to have someone with anthropological training. If you could have the WHO outline general principles for ethics in research, and have well-trained anthropologists advise how to implement these principles in specific cases, we might see more ethical and equitable research.

    I also wanted to comment quickly on your mention of the Chernobyl incident. While the government did allow unethical studies to be done after the crises, Paul Farmer mentions in his review of unintended consequences In Reimagining Global Health that some government responses were good. While only a couple thousand were affected by the disaster, a full third of the population was compensated for perceived damages done by Chernobyl and primary health care dramatically improved. While research for aid was bad, the outcomes of the state-implemented health care were very good.

    In this case, misunderstanding of health impacts on population led to good outcomes, while the way in which foreign parties tried to understand those health impacts lead to bad outcomes. I wonder if we can learn anything from the way research and implementation intertwine.

    1. Hi Benjamin,

      Thank you for your comment — especially for giving me more insight into the Chernobyl incident. It is definitely a more hopeful story with the information you provided, however I think the fact that the research was still allowed to be performed with such little consideration of ethics is really the heart of the issue. What scares me about Chernobyl is how readily the government used a health crisis as an opportunity to perform medical research. Governments, just like pharmaceutical companies, are nuanced entities, and their performance of one good decision does not remove the stain of the bad ones.

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