Many of the articles this week criticize the use of strictly regulated clinical trials for being unable to treat research subjects as members of unique communities, or fully evaluate the holistic impact of a drug or intervention on a community. Simultaneously, authors like Adriana Petryna in Ethical Variability argue that the ethical standards used for research subjects in developing nations differ from those in developed nations, and she alludes to the need to implement further regulatory practices to equitize the way human subjects are treated.
I would argue that to ensure all populations are treated ethically, regulations for trials intended to create reproducible results need to be even more strict than they are now. For example, in almost no circumstances should for-profit companies be given regulatory passes, or be allowed to follow different ethical standards during situations of humanitarian crisis, becuase too often these situations are used to exploit suffering populations further. For example, when Pfizer wanted to expedite FDA approval of Trovan in 1996, they were able to successfully take advantage of a meningitis outbreak in Nigeria to conduct faster clinical trials by ignoring getting patient consent and giving their experimental pill to Nigerians who did not know they had safe and proven alternatives available to them (Petryna, 2013). Ultimately, the use of an expedited clinical process resulted in an easy way for Pfizer to hide evidence that Trovan causes severe liver damage (Petryna, 2013). Additionally, Dr. Chan of the WHO denounced how pharmaceutical companies handled developing an Ebola vaccine, claiming that there is no vaccine because “a profit-driven industry does not invest in products for markets that cannot pay” (Gladstone, 2014). Furthermore, she noted that it is subjects in the United States who were initially targeted to be the subjects for upcoming vaccines, rather than those in developing nations. This is problematic since subjects for risky clinical trials are almost always recruited from developing countries, but are unable to benefit from this vaccine that could immediately directly benefit those citizens.
Rather, if a situation is severe enough that it requires expedited processes, third party organizations that are not-for-profit should be used for conducting trials when removing certain regulations. It is not in any sense altruistic for a for-profit company to perform legally required trials in cheap areas of the world, regardless of the humanitarian need or perceived benefit in the local community, and FDA regulations should reflect this reality by ensuring that pharmaceutical companies are treating subjects the same way they would in any developed nation. It is far too naive to assume a for-profit company is acting out of humanitarian obligation, and thus the use of scrutinized trials and regulations are necessary, no matter how impersonal. Randomized clinical trials (RCTs) are considered “the gold standard” of research methods because they prove an outcome is not due to chance, and are designed to avoid observer bias (Adams, 2013). RCTs are absolutely necessary for any drug, treatment, or intervention intended to be replicated on a large scale, especially those done by for-profit entities. Of course, RCTs will not report on many unintended consequences, but there is no guarantee unstructured observation will either.
The larger question is, how often is it preferable not to create interventions that are replicable on a mass scale? It is crucially important to recognize that the most beneficial health interventions are often purposefully tailored to a specific community and culture, and are not intended to be reproducible in other contexts around the globe. In When People Come First, Vincanne Adams talks about how problematic it has become that showing that a study is reproducible is more important than showing an intervention positively impacts health. In settings in which non-profits are performing health interventions or responding to humanitarian crises, it is essential that time, money, and health outcomes not be jeopardized by turning interventions into research studies.
In an increasingly for-profit sphere, money intended to go towards impacting communities is instead going into designing and proving the effectiveness of interventions as research studies. There is often a mandate to turn interventions into research, and hire research and consulting firms and for-profit NGOs, as well as purchase expensive ‘reliable’ assessment instruments in order for an intervention to be seen as credible. While cost-effectiveness analysis should never be the only justification for performing an intervention, it is clear in this situation that performing an RCT would be a much more inefficient use of money in the short-term. In the long-term, if we understand that different communities have individual needs, interventions must constantly evolve, so a specific RCT would not be cost-effective in the long-term either. Ultimately, nonprofit interventions should only be designed to have the most beneficial local impact, while for-profit interventions should be intensely regulated no matter the humanitarian need.
Sources:
Biehl, João Guilherme., and Adriana Petryna. “Evidence-Based Global Public Health.” When People Come First: Critical Studies in Global Health. Princeton: Princeton UP, 2013. Print.
Petryna, Adriana. “Ethical Variability: Drug Development and Globalizing Clinical Trials.” American Ethnologist 32.2 (2005): 183-97. Print.
Gladstone, Rick. “W.H.O. Assails Delay in Ebola Vaccine.” The New York Times. 03 Nov. 2014. Web.
Discussion Questions:
- Should global health interventions and responses to humanitarian crises be regulated differently in situations in which for-profit companies and non-profit companies are performing global health work?
- Is it always justified for nonprofit humanitarian global health work to avoid using the research methods of randomized controlled trials (RCTs)? Do RCTs offer substantial benefits when evaluating global health work?
- Ultimately does turning a health intervention into a controlled research trial create an inherent tension of academic good and rigour vs. social benefit, as Petryna suggests?
I couldn’t agree more with you, and great job by the way. I don’t think a for-profit company has any business in humanitarian work. At least, in direct hands-on humanitarian work. It would appear those corporate fund-raisers or social equilizing events you see large banks and tech firms throw do actually provide innumerable benefits to marginalized members of society, but those benefits are mainly in the form of financial assistance for the disadvantaged, and tax breaks for those who are not. But in this case, Pzifer, very much a for-profit company, behaved like one. It disregarded the needs of the “patients” for whom Pzifer conducted its clinical trials because their lives fall second to making a profit.
That said, just by taking a cursory glance at Pfizer’s website, I noticed that it appears to be involved in plenty of charities, grant giving and academic partnerships that undoubtedly have to yield some common good in society. I do not deny that all this is probably serving to only lessen its corporate tax burden…but in the end, do motives behind doing good in the world need to be scrutinized?
Hey Chad, thanks for responding! I think your point about whether motives matter brings up a good point about intent vs. impact. Of course, the ultimate goal is to have the most meaningful impact on under-resourced communities around the globe, and your point suggests that the intention behind why people are acting is not relevant to analyzing global health work. However, I think understanding the intentions behind “doing good” do need to be scrutinized when there is a large potential for harm or unintended consequences. This reminds me of a question Sara posed in section, which is “Do you have to care to perform successful global health work?” While I agree with you that the motives matter less when companies like Pfizer are involved in grant-giving, and aiding charities, I think caring is critically important for success when directly interacting with vulnerable populations. So let’s encourage both nonprofit and for-profit organizations do get involved, but let’s also critically assess what impact their motives are having on the outcomes of their work.
Great post. I agree with you on that for-profit interventions should be intensely regulated to prevent any indirect intentions that these interventions can aim for. Yet in the example of MRC in Gambia, the MRC did actually help the Gambian people by medically treating them although their intention was to only conduct a research that was not even explained to the people in Gambia. So my question is how much regulation can we have before it starts to be discouraging of humanitarian work? And how can we set such limit?
Hi Maen, thanks for this response, that’s an incredibly difficult question to answer. I think in situations where it would still be very profitable for drug companies to aid in humanitarian crises, that’s a situation where we have more leverage to implement regulations without discouraging humanitarian work. I think it makes sense in time sensitive situations with vulnerable populations to require that a third party organization do drug testing and evaluation, so that there’s no bias of results, and that drug companies would not pull out of situations because of this requirement. You’re absolutely right though that we have to critically ensure that any new regulations or limits won’t interfere with the ultimate goal of providing specific resources to communities that are lacking them.
Hi Alana, thank you for your insights. I definitely agree that for-profit organizations should be more rigorously regulated than nonprofits because ultimately their actions are motivated in the interest of making money. This takes precedence over humanitarian decisions that would most benefit the populations they are working with. I think that both global health projects and academia can benefit from the use of RCTs and that consent is the biggest factor in the success of RCTs because if people involved in the trials are clearly explained the pros and cons of participation and the treatment is delivered by a company that respects their decisions devoid of trying to generate a profit, the health result can be successful and ethical. Zoe’s post elaborates more on the issue of consent and she brings up some really good points in the complicated process of medical communication between the scientist and patient.
Hello Alana,
I appreciated the distinction that you made between non-profit and for-profit interventions. As the general public, we allow profit-seeking organizations to conduct research in undeveloped countries without considering their true intentions, and we remain oddly complacent in their excuse of seeking to address humanitarian needs and benefit to local communities. As you stated, this allows for such industries to exploit vulnerable communities for their own gain.
I think greater attention should be paid to global health interventions of for-profit companies in response to humanitarian crises than should be paid to those of non-profit companies. As the readings you mentioned discuss, it is in times of emergency that for-profit companies feel the most empowered to capitalize upon the desperation of vulnerable individuals. Furthermore, if one were to accept interventions as being more crucial than corresponding research studies, than the deviation of the research methods of nonprofit groups from randomized control trials is justified despite the statistically valuable information that such trials can reveal.
We’ve discussed in class how Paul Farmer and others in his field are champions of the moral obligation to act when deciding to help those in need. I found your discussion of the unethical nature of using interventions for research studies to be an interesting parallel to Chapter 3 of Arthur Kleinman’s What Really Matters, which emphasizes the importance of researcher being involved in the lives of those who are studied. While this blurs the objectivity of research in exchange for helping those in need, Kleinman condones the essentiality of doing so. Your statement of keeping out for-profit NGOs seeking to do research in conjunction with certain interventions is a very effective extension of this previous argument. Furthermore, in response to your last discussion question, it is for these very reasons that there is an inherent tension created when a health intervention is turned into a controlled trial for study.
Hi Alana,
Great post. I just wanted to add a quick comment about the third question, when Petryna suggests that there is an inherent tension between academic rigor and social good. A question I had is whether such a clearly cut distinction can be made between the two when it comes to controlled research trials. The academic rigor required by the FDA is for the social benefit, ensuring that a drug is properly tested so it doesn’t end up harming the target population. In this sense, I think the contradiction created by CROs is less of one between academic rigor and social good than immediate social good and preventative future social good. I don’t think there’s much difference between the two except for the time it takes for populations to experience their benefits.
Of course, this doesn’t change the fact that these CROs are taking advantage of vulnerable populations in times of crisis, and that pharmaceutical companies should explore other avenues of testing their drugs. But it’s something interesting to think about.
Hey Ben,
I definitely agree with you that in the case of pharmaceutical trials, the tradeoff is between immediate social good and preventative future social good. Thank you for bringing this nuance up! Often times pharmaceutical drugs needed to be tested in a very controlled manner to ensure they are not causing long term harm.
However, when talking about RCTs outside of a pharmaceutical context, in a situation where a health intervention and not a drug is being tested, I do think the use of some RCTs can be unethical. For example, in Infections and Inequalities Chapter 3, Paul Farmer talks about how be believed implemented a placebo arm for his ‘study’ on treating Tuberculosis in Haiti would be unethical when he has the means to give treatment, even though that attitude is frowned upon by the academic community. Farmer decided to give every arm treatment, just different forms in order to truly determine which was the most effective before switching everyone to the most effective treatment option (which in this case meant giving nutrition and transportation stipends as well as medicine to patients).
Do you think in interventions that do not involve the testing of medicines, that a placebo arm can be unethical and detract from the health of a population? Or that turning an intervention in an RCT can cause researchers to become more concerned with whether a study is ‘academically rigorous’ as opposed to whether it has the best health outcomes, therefore affecting both short term and long term health of a population?
Hi Alana,
Thank you for your post, your comparison of for-profit and non-profit companies in the realm of global health was very informative. I agree with you that the international efforts of for-profit institution and non-profits should be regulated differently. Obviously, for-profit companies, such as pharmaceutical companies, have an ultimate goal in their research. These companies want to sell their product, whether that is a drug, a technology, or an evaluation service. While it can be easy to find the danger in letting for-profit companies get involved in global health interventions, I do think in some cases such companies can be motivated for the right reasons. Ultimately non-profit companies, while they may not be driven by profits, they are driven by donors who have specific results they want from their investment. I believe that being able to regulate both classes of companies is crucial when preforming research in impoverished areas of the world.
Randomized controlled trials have their benefits and their drawbacks. In terms of understanding the impacts of a nonprofit company, RCTs can provide unbiased results as to the successes of programs. However, RCTs work by not considering the culture of a community, which as we have learned, culture is extremely important when it comes to delivering healthcare. Additionally, RCTs only provide a quantitative measure of results. Often, the effect of an nonprofit in a community has a much larger qualitative effect than a quantitative one, which can be missed in RCTs. Additionally, while the information from an RCT can show success, the trial may not actually benefit the community. In When People Come First, an example was given how the evaluation of the RCT said that a successful trial was conducted, but the people of the Tibetan community experienced no change in health from the efforts. By placing too much emphasis on research control trials, health organizations can lose sight of the people that they are trying to help.
Great post! I completely agree with you in that for-profit organizations should not be given regulatory passes during situations of humanitarian crisis. I also agree that this lack of freedom will help to lessen the exploitation of the suffering population. In terms of RTCs, I believe that they do benefit global health however; it is necessary that there is consent. Without consent RTCs are unethical. I agree with Zelda, when she says that people involved in the trials need to be aware of the pros and cons of the treatment. If consent is given, in my eyes, the study is ethical and whether or not profit is generated from the RTC is irrelevant.
Hi Alana,
Thanks for your post–it was really interesting to read! I agree that regulations for RCT could definitely be stricter than they are right now. You brought up two great examples that highlighted the need for equipoise in any randomized control trial, and I completely agree that a researcher is ethically obliged to have genuine uncertainty regarding the comparative therapeutic merits of each arm of a trial. I was a little challenged by your conclusion that “if a situation is severe enough that it requires expedited processes, third party organizations that are not-for-profit should be used for conducting trials when removing certain regulations.”
Perhaps I am being a bit pessimistic, but I am having a hard time picturing a non-profit trying to conduct an RCT to test drug efficacy. Ultimately, non-profits are driven by donor obligations, which don’t often include resources and budgeting to effectively conduct these sorts of RCTs. Creating any sort of drug is incredibly expensive, and conducting these trials is also very expensive, and I’m just not sure non-profit companies have the resources and capabilities to do this.
I also think that in some cases, it can be unethical for for-profit companies not to get involved with global health interventions. Something that we discussed in my section was the Ebola and AIDS outbreaks and the criticism that many pharmaceutical companies got for NOT providing drugs that had not been clinically tested/proven to work to treat the diseases. In both cases of outbreak there was outcry from the international community that for-profit companies were not handing out these possible treatments to people in developing countries. I think that it is really tricky, and a kind of ‘damned if you do, damned if you don’t situation’ for pharmaceutical companies in the world of global health. I think that in some cases it might be necessary for for-profit companies to have certain regulations removed to speed up the drug approval process, however I think that in most cases the regulations for for-profit companies should be stricter than they are today.
-Rebecca
Hey Rebecca,
Thanks for your insights! To clarify, when I talk about RCTs throughout the post, I am not primarily referring to pharmaceutical RCTs to test drug efficacy. Rather, as Vincanne Adams talks about throughout her chapter in When People Come First, I am discussing the trend of standard global health interventions being conducted in RCT format, rather than just treatment format. To give an example (the same one I use in my response to Ben’s comment), in Chapter 3 of Infections and Inequalities, Farmer conducts a sort of RCT when figuring out optimal treatment of tuberculosis in rural Haiti. Farmer, recognizing that RCTs can be unethical due to their use of placebo arms, decided not to have any segment of the study not receive treatment, and instead simply varied the degree of social and financial support the people he was helping received. While I understand this model may not be feasible while testing drugs, I agree with Farmer that avoiding the use of a complete placebo arm should be the goal in other forms of health interventions.
I also understand that it can be unethical for for-profit companies not to get involved with global health interventions, as they often have the resources to help. I think you’re absolutely right we should expect all sectors to get involved with health crises. In my ideal world, when companies are in a situation where they could profit off of humanitarian crises, that’s when I would want a third party organization to perform trials or interventions, to ensure all behavior is ethical.
As you’re saying though, ” it might be necessary for for-profit companies to have certain regulations removed to speed up the drug approval process” so do you think this use of a third party organization would slow down the process and delay the speed to which certain populations could receive drugs and treatment?
Hi Alana,
Thanks for clarifying what you meant in terms of RCTs!
I think that involving a third party has the potential to slow down the process and delay the speed to which certain populations could receive drugs and treatments, but hopefully it wouldn’t! I think in any intervention, or honestly, any situation, involving more people can make decision-making harder because it involves more perspectives and therefore more considerations. I think the key to making this third-party process successful would be to have outlined steps for what the processes and deadlines would be in this sort of emergency situation established before the actual emergency situation occurs (which I think you are suggesting too based on your post). If that’s the case, I think that having a third-party organization could be a successful way to ensure all behaviors are ethical!
Thanks,
Rebecca
Alana – I appreciate the differentiated view you took on non-profit versus for-profit health interventions, and I agree that there should be strict regulations in place especially in cases when the intervention is done by a company that stands to profit from the results. In the matter of research in the context of health interventions run by nonprofits, I find it hard to make a blanket statement that generalizability shouldn’t be the goal. There is of course value in localized effective interventions, but if the possibility of expansion, and as a result benefit to a larger group of people, exists, I believe it makes sense to conduct the research to make an educated decision. This of course doesn’t mean that every intervention must be based around a RCT, but rather the possibility of expanding the scope of knowledge and benefit from a project should always be considered.
Hi Alana,
I really enjoyed reading your post. I especially like your claim that it is important not to jeopardize health outcomes for the sake of research. And I agree with your point that for-profit interventions must be intensely regulated, without exception, since we cannot assume that for-profit companies will operate altruistically.
I think your third question regarding academic rigor vs. social benefit is very interesting. As Petryna suggests, I think that a healthcare intervention-turned-research trial does create inherent tensions. If you turn an intervention into a randomized controlled trial, then some people may not receive treatment, or receive different forms of treatment. And those different forms of treatment are administered before knowing which may be the best or most effective or least harmful. That said, it is important for RCTs to exist—without them, modern medicine could not move forward with new innovations, since innovations have to be proven, with high certainty, for safety and efficacy.
Thank you, Alana and others, for your comments on the standards of regulation for companies performing global health work.
To address your first question, I would like to begin by politely pushing back on the previous comments, like those posed by Sachit, Rebecca, and Lindsay, which state that there should be stricter regulations in place for for-profit companies as compared to non-profit companies. I wonder why we’re not advocating for the same, strict regulation for both types of companies because it doesn’t seem so black and white to me. There are “good” people in for-profit companies and “bad” people in non-profit companies, so why are we attempting to hold them to different standards? If we assume that all non-profit companies only do good, we probably wouldn’t even be in this class, where we’re analyzing the intentions and unintended consequences of numerous global health projects. For-profit and non-profit companies alike need to continuously think about the impact of their work. That being said, I understand where others may have been coming from, realizing that the objective of for-profit companies is to reap profits. I am just highlighting that non-profit companies may also have some kind of “agenda” because of their donors who may specifically allocate funds for one project and not another.
With the aforementioned idea of non-profit companies having to fulfill certain donors’ requests, I would like to address your second question. As Rebecca pointed out, non-profit companies may not have the resources to conduct RCTs because they are incredibly expensive and time-consuming. Accordingly, I would have to say it is sometimes justified for their work to avoid the use of RCTs, even though they do have the potential to offer substantial benefits when evaluating global health work. Often, the primary goal of global health work is to come up with a solution that is specific to a community’s needs. Yet, if the researchers’ findings can be translated and diffused into other settings, then that would be an added benefit.
Hey Natalie,
Thank you for bringing those points up! You are right that nonprofits often also have their own agendas while performing health interventions, and that it is critical to regulate any type of health trial or intervention being performed. And we have seen over and over again throughout the course that unintended consequences can happen in any settings. However, some of the regulations that would avoid historical problems that we’ve seen would be more relevant to for-profits as opposed to nonprofits. For example, when testing the efficacy of a drug, pharmaceutical companies in the past of used humanitarian crises as a means to profit off of those suffering and get their drugs on the market faster without investigating potential harms. That’s why I brought up the idea of having a third party organization conduct the clinical trial in certain high stress situations, which wouldn’t usually apply to nonprofit interventions.
Do you agree that in certain circumstances it would make sense for a third party organization to conduct trials instead of a pharmaceutical company? Do you think in some circumstances there should be third party involvement in nonprofit interventions as well?
Thank you, Alana, for the great post – it really forced me to think about how unequal access to current and unbiased information is a major player in the making health decisions amongst people who are socially or economically disadvantaged and/or reside in developing countries and encounter pressures of looming and life-threatening disease. In regards to your third question, Petryna’s mention of underinformed subjects brings up a profound ethical issue with clinical trials as intervention, and that is a heightened sense of a power differential between researchers/people delivering care and resources during the research, and the subjects who engage with the research as a means of receiving medical attention and care. I think this power dynamic is important to consider when developing plans for responsible research and intervention in developing countries, and it is important to consider the harm that power differentials can cause in spheres of healthcare.
Thank you for your detailed and thoughtful post, Alana.
I appreciated how you mentioned the idea of tailor-made solutions that are specific to a country. Granted, when dealing with major health issues or widespread health concerns, it is not always practical or efficient to develop region-specific solutions to health problems. It is possible to utilize the power afforded by engaging both non-profit and for-profit groups to work in an RCT format when trying to develop solutions. This will provide a greater likelihood of solutions that fit well with the specific concerns of a country because the combined pool of resources that comes from contributions from all sectors can garner support from a nation’s people as well.
I would also like to mention your point about interventions turning into research studies. When a humanitarian effort turns into a research study, there is a high possibility that the outcome will be a great deal of usable data, but throughout the course we learned about what works and what does not work when it comes to healthcare interventions, and it is important to realize that if we focus on communities as laboratories, it removes the human aspect of what global health workers are doing, and I think that is too high a price to pay in the hopes of achieving future success in the health sphere.
Hey Shreya,
Thanks for your discussion of the added benefits RCTs can have on planning future interventions! I also agree that it’s important to pool resources from all sectors for global health purposes, which include leveraging money from academic and for-profit spheres. And while I agree that one unintended consequence of turning interventions into research studies is that it can have a dehumanizing effect on the populations we’re working with, I think the larger unintended consequence is turning the attention away from health outcomes, and instead makes them focused on this ‘useable data.’ I think the ethnographic model of anthropological research should be the model of how we evaluate and re-create successful global health projects, as opposed to RCTs and cost-benefit analysis.