All posts by Zoe Gilbard

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?