All posts by Alana N Bhatla

When Health is for Sale: The Need for Different Levels of Regulation in Global Health Interventions

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:

  1. 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?
  2. 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?
  3. 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?