Clinical Trials in Practice II: Contract Research
“The Contract Research Organization and the Commercialization of Scientific Research” 2005.
Philip Mirowski and Robert Van Horn provide their own perspective, as a response to competing views, on the introduction and rise of Contract Research Organizations (CROs). The authors acknowledge that study of CROs is an area without a well documented history, and yet the prevailing view is that the presence of CROs is largely due to cost saving measures of pharmaceutical companies. Mirowski and Van Horn disagree, and present a different picture of CROs; one that emphasizes a particular climate in the scientific community where a series of events came together (in an almost convenient way) around the 1980s that led to the introduction and rise of the CRO (p513).
By asking “how has research in a CRO been altered by the imperative of commercialization?” (p508), the authors hint at the complexity and interconnectedness of CRO involvement within the private research industry. This “re-engineering of the structures of scientific research” (p504) has become realized in such a way that it is difficult to pinpoint its origin. It’s not a matter of CROs driving the change in research, or pharmaceutical companies demanding CROs, but subtle changes in industry, over time, that resulted in altered research. The authors go into detail of those changes:
Efforts of the FDA to standardize the drug development process materialized with amendments to regulations that increased review periods, which in turn contributed to a drug development cycle that exceeded ten years (p508). This proved costly for pharmaceutical companies because the increase in time could render the drug irrelevant, and the upfront costs of development meant less money for patents (p510). So there was a particular moment that coincided with stricter regulations and corporations’ ability to adapt that contributed to the introduction of the CRO. These organizations specialized in meeting targeted clinical trial deadlines by employing such tactics as mobile clinical recruitment, and on demand stop-start research for a low cost (p511).
When the FDA permitted the use independent IRBs for FDA-regulated research, bioethics consultants appeared on the scene. CROs were able to utilize these consultants in a way that academic institutions could not, and as a result, CROs became privileged with exclusive ethics review of their scientific protocols which were not subject to lengthly delays as their academic counterparts (p515). Increased regulations in the USA fostered the mobile flexibility of CROs while leaving academic researchers behind (p516). Efforts by the FDA to protect participants led to opportunities for private consultants and offshore research.
The authors observed how there was a risk for pharmaceutical companies working with academic organizations because of the potential of their proprietary interests being shared with competing companies (p523). Working with CROs is considered ‘safe’ because their “predominant interest is simply to deliver a product on time and under budget. In CROs, conflicts of interest are not perceived as a problem requiring special remedy or concern, because the new format has built-in means to discipline them. This is a consequence of the change in the organization of science” (p522). CROs are also willing and able to accommodate pharmaceutical demands for selective disclosure and publication embargoes in ways that their academic counterparts may be reluctant to (p518). And patent exclusivity can be secured through contracts between industry and CROs (p524).
With respect to publication and authorship, the nature of CROs seems to accommodate guest authorship and and ghost writers. Contractually, CROs have no interest in publications. And when the authors investigate this an interesting component of CROs is revealed: what is typically a driving force for academic research is often mimicked and then distorted within CRO, such as the function of authorship (p530).
The authors conclude by revealing how ‘knowledge’ cannot be the purpose of clinical trial activity because that ignores the contributions of CROs (p532). The sole purpose of a CRO is to facilitate the approval process for new drugs. The irony is that ‘new’ drugs are rarely produced from this process, but rather the me-too drugs (p532). And so it becomes clear that the contributions of CROs and the existence of clinical trials is to provide opportunities for advertising, which is of course necessary for the success of the me-too drug (p535).
“Clinical Trials Offshored: On Private Sector Science and Public Health” 2007.
Adriana Petryna provides an ethnographic account of offshore clinical trials in lower-middle income countries, and how these occurrences have become modes of public health in those countries. Some of elements of the rise of CROs that Mirowski and Van Horn discussed are referenced in Petryna’s piece, but she also goes into some depth describing conditions of clinical trial subjects, such as “treatment saturation”, which has rendered patients in the USA and Western Europe ineligible for clinical trials (p25).
Petryna interviews players involved in the offshoring of clinical trials and highlights their “recruitment strategies” and abilities to “engineer out” adverse events (p27). Industry catch phrases such as “treatment naïveté” are learned as the ‘benefits’ of offshoring are realized: “populations that (apparently) have not been diagnosed or treated for a particular condition… are considered incredibly valuable” (p28). Those populations don’t ‘suffer’ from treatment saturation and are considered to have fewer variables (p28).
Another catch phrase, “equivalent medication”, refers to the local equivalent to the Western standard of care (p30). An indication that researchers are aware of more effective treatments but attempt to justify their treatment choices by local standards, which also allows the population to remain relatively treatment-naïve (p30). And when those clinical trials are accruing slowly, CROs relocate the study to another region in what is known as a “rescue study” (p34). These are just some examples of how offshore clinical trials have shaped the public health in host countries. The effective use of industry catch phrases is indicative of business operation. But the system is not as ‘functional’ as we’re led to believe. Petryna’s interviewees acknowledge the “paradigm of expected failure”, whereby data from the treatment naïve populations is not necessarily transferable to the treatment saturated populations (p37).