The Experimental machinery of Global Clinical Trials: Case Studies From India
Rajan introduces the idea that clinical trials are the experimental machinery of biocapital. Biocapital encapsulates scientific production, value generation and commodity circulation as it pertains to the biomedical field. Clinical trials are the machinery insofar they set of practices necessary for a drug to get to market. By looking at clinical trials, Rajan wishes to study the globalizing dynamics of global capital in terms of consequences and reasoning for outsourcing.
Rajan describes the stages of clinical trials from animal testing, to safety and efficacy tests on a small number of healthy humans, all the way to large scale randomized trials that are typically suffering from the condition the drug is proposed to treat. These final stage large-scale trials are of particular interest as they are coordinated across many centers, increasingly globally and now almost entirely undertaken by the private sector.
The complexities of clinical trials burdening the pharmaceutical companies led to the emergence of Contract Recruitment Organizations to manage them. CRO’s are emerging in India to provide service mainly to large Western Biotech and pharmaceutical companies. The paper goes on to describe the Indian clinical trials environment wherein the subjects are ‘merely risked.’ Subjects come to be merely risked as a result of the relationship between clinical trials and drug access. In west there is an implicit notion the clinical trial subject holds wherein they believe they are contributing to the creation of a drug that will help others and possibly them as a result of the trial. In India, there is no promise that the drug tested will be marketed in India. It is more likely that Indian experimental populations are used as subjects without any implicit contract that they may one day get access to new therapies. The Indian subjects contribute in some ways be taking part, but this is not necessarily related to their own healthiness or the nations well being. Being a trial subject becomes then just high-risk labour, hence they come to be ‘merely risked.’
Physicians often conduct Phase III trials involving sick patients as experimental subjects, as such they hold a different set of ethics than the CRO’s who are often dealing with Phase I, healthy volunteers. As a result, many physicians insist onl inking clinical experimentation with therapeutic access for their patients after the trial. Despite debate, the only real access to experimental drugs is through compassionate use programs, which provide experimental drugs to Phase III subjects for a fixed period after the trial. In contrast, the CRO industry sees no need for drugs tested in India to be market there. Hence the upshot of Indian clinical trials is that the subjects provide the possibility for global neoliberal consumers to attain new therapies.
The Indian CRO industry is expanding rapidly, building infrastructure to attract trials and increase recruitment. The merely risked bodies of poorer countries are subject to the logics of expropriation – their bodies are made available to global systems of experimentation, driven by the valuations of pharmaceutical capital.
Rajan is also interested in the partial ethics of Good Clinical Practice, which enables structural violence of capital. The informed consent form frees the subject from being coerced and signifies them as autonomous agents. According to Rajan the global harmonization of ethical standards have contributed to the situation of merely risked subjects. Preexisting global structural inequality results in subject costing much less in India. Though the contract frees the subject as autonomous, Rajan invokes the Marxian concept that the only way persons become workers for capital is through preexisting violence that force people into proletarianization.
I agree with Rajan that preexisting violence just like the structural impoverishment and exploitation of third world states, puts huge populations in a position to work for biocapital as experimental subjects. Until the drugs being tested for are marketed, and I would argue, useful in the Indian context (i.e. drugs for tropical diseases, not hypertension), Indian experimental subjects will continue to be merely risked, ultimately being treated as an means to capital gains.
The Rise of Recruitmentology: Clinical research, racial knowledge and the politics of inclusion and difference.
Epstein discuses a new auxiliary science that has emerged in the field of clinical trails which he names ‘recruitmentology.’ Recent recruitment mandates imposed by US Congress, the FDA and the NIH, have imposed required inclusion of racial and ethnic minorities and women in clinical trials. These mandates were brought about due to awareness of ‘racial disparities’ in health outcomes. In the US specifically, various groups were considered to be continuously underrepresented in clinical trials.
Recruitmentology has emerged as practitioners of the discipline began working towards the production and diffusion of knowledge about the best ways to recruit and retain participants – especially in populations viewed as hard to reach. Clinical trials are now caught in cross cutting pressures, they need to show diverse recruitment, demonstrate to regulatory boards that they are not exploiting populations and respond to prevailing suspicions in minority communities surrounding experimental research. ‘Soft’ recruitmentology usually takes the form of advice literature such as the presentation of successful recruiting strategies. ‘Hard’ recruitmentology attempts scientific methods and analysis. Despite recent growth, recruitmentology still lacks the institutional structure of actual auxiliary science.
In Epstein’s view, the new bureaucratic mandates reinforce problematic definitions of race as discrete groupings that are biologically distinct. This narrow conception of race is embedded within the biopolitical framework. The practical work of recruiting promotes the approach of seeing different ‘targets’ (racial/ethnic groups) as a collective actor with knowable sociocultural properties. The former conception overemphasizes and simplifies biology in terms of race and gender thus detracting from the main goal of eliminating health disparities.
Epstein marks on many of the same points as Rajan when discussing the globalization of recruitment for trials. He finds that in poorer locations costs are reduced and patients are ‘pharmacologically naïve.’ Regarding India, Epstein had similar concerns about the fact that new drugs tested there will not be accessible to most of the Indian population, and that rich Westerners will reap most of the benefits.
The hybrid character of biomedicine as a natural and human science lends itself to the injection of social science analysis. Clinicians use social science knowledge to help research teams, advertise the trials more effectively, locate subjects and forge alliances with communities. Recruitologists takes on many tasks: some aim to determine barriers preventing people from volunteering others analysis and created knowledge about groups, another section deals with a cost benefit analysis. All these facets reflect presumptions about the kind of cultural object being analyzed; trends toward seeing targets not as individuals to be recruited, but the social subgroup in which they belong. Again we see the two conceptions, one of the group as a social actor, the other seeing the group as something akin to a census category. Throughout his paper Epstein promotes the focus on race with reference to sociocultural and sociohistorical properties of organized communities. Conceiving of the groups from which clinicians are now required to draw from in this community – like sense lends to recruitmentology the tools of community outreach and collaboration on studies. These techniques have been shown to be successful for recruitment and retaining of subjects, and if undertaken honestly, have the added benefit of not disempowering groups.
‘Ready to Recruit’ or ‘Ready to Consent’ Populations? Informed Consent and the Limits of Subject Autonomy
Fisher brings two new terms to the table in her article. First ready-to-recruit a term that simultaneously suggests that the public is composed of potential human subjects, and that the pharmaceutical industry is ready to pounce on disenfranchised populations – offering them inadequate health care in exchange for their time and bodies as experimental subjects. This term and mindset emerged out of the transition of clinical trials from largely US academic institutions to private sector driven, increasingly globalized institutions.
The second term ready to consent, describes the populations who actually participate in the trials as they lack better alternatives. This is a reframing of the same populations that allows Fisher to question the operations within the industry that exploits certain groups.
Informed consent is demanded by ethics and the US government on premise that individuals act as autonomous, rational beings. Many advocates for protecting human subjects have recommended informed consent become a process, not just a form. Another idea is to have the patients/subjects be in partnership with researchers, however in larger trials this is implausible because physicians often conducting trials they did not design.
Many assume informed consent starts when potential subjects are given information – usually the informed consent form (a screening and consent visit). This neglects the fact that most potential subjects have already decided to participate; consent begins before information. This makes recruitment integral.
Fisher quotes Epstein in describing the increasing scientific formalization of recruitment. She also notes the proliferation of advertising for trials. These ads are specifically designed to not just recruit persons, but also increase the salience of clinical trials as an option for them, often framing them as potential magic cures. There are few disclaimers, never mentioning placebo use, risks, and burdens of participation.
Fisher finds that Phase I research is mostly filled by low – income, minority men who need the money. Phase II & III trials are largely enrolled by White women with no health insurance. This corroborates the sense that clinical trials have come to serve as faulty resource for the disenfranchised. Fisher then makes her point that structural variables are much stronger determinants of participation in trials than the details of the study outlined in the consent form.
Through the examination of three different volunteers decision making of enrolling in three different trials, Fisher found more evidence that the information given on the consent forms and in the screenings mattered little in the decision making process. She concludes that holding autonomy and informed consent as ethical model neglects social contexts and structural factors on decision-making. Though are current model of consent now seems inadequate to protect against abuse of subjects, the proposed replacement models cannot account for power imbalances. This idea connects to all three reading’s concern with vulnerable populations, both domestically and abroad. Now, with structural conditions in the US requiring the participation of marginalized and minority groups, it is even more imperative that subjects both are entirely informed and treated with adequate health care.