Brian Salter, Yinhua Zhou and Saheli Datta have recently published on Social Science and Medicine a thoughtful article on “Hegemony in the marketplace of biomedical innovation: Consumer demand and stem cell science” (ref 1). The article documents the emerging of a new model of biomedical innovation centered on patients’ demand and clinical methodology. In their opinion, this model is threatening the “hegemony” of the supply-side model of innovation based on scientific experimentation (e.g. randomized clinical trial) that currently informs regulation. Their illustrative example pertains to stem cell research and the debates surrounding the approval of cell based treatments (including the Italian “Stamina” case, ref 2). Towards the end, they describe the adaptations and political compromises that regulators are making to accommodate such emerging model of innovation – also focusing on stem cell therapy. However, the authors systematically hint to a broader shift, a shift that involves patients becoming subject-researchers, i.e. no longer passive recipients of research and development but active co-creators of biomedical products on the model of HIV activism (as described in the classic Epstein’s “Impure science”) and more recent “evidence based activism” (ref 3).
The core theoretical proposal of the paper is the employment of some Gramsci’s categories to understand this phenomenon. In particular, they describe the ideological “hegemony” of the “historical block” of social forces currently dominating biomedical innovation as being threatened by a patient-led “counter-hegemony” challenging the status quo by means of its own ideology.
According to the authors, the dominant social block includes industry and state regulatory bodies, and it is underpinned by the idea that research is generally conducted without active involvement of patients. Also, “the ‘demand’ for the products of innovation is seen to originate in the systems of reimbursement, primarily state and insurance funds, in which health consumers are embedded. State and insurance organisations make choices on behalf of health consumers” (ref 1 – pg.4). In the context of stem cell research, patients are challenging such model “through a preparedness to accept the products of the practice-based model of medical innovation employed by the stem cell clinic providers, a model roundly denounced by supporters of the hegemonic model of scientific innovation. The two models are informed by the contrasting values of medicine and science” (ref 1- pg.5).
The process that the authors are describing is very important, and it reinforces a more general trend towards participatory element in biomedical innovation, including citizen-powered social network-mediated research, open innovation and a renewed importance of post-market drug research and clinical observations. However, it may be too early to decide on the nature of both the “historical block” and of its counter-hegemonic challenger.
Davis and Abraham (ref 4) have shown that drug regulations evolved in the context of ‘80s and ‘90s patient activism as a result of corporate capture of state regulators. Far from being a counter-hegemonic patient-led challenge to the social block that then dominated biomedical innovation, the dynamic of regulation resulted from what they call the “patient-industry” complex. This suggest a competing hypothesis to Salter, Zhou and Datta’s thesis. We might be observing not so much an emerging “counter-hegemony” led by patient-consumers that are tipping the balance in favour of clinical methodology against the “historical block” of science-led industrial research pipeline, but a reorganization of industry led by industry, perhaps driven by actual or projected declining profits, aimed at extracting value by relying on consumer-led innovation.
If that was the case – but probably it is too early to amass data to prove one or the other thesis – the political economy of the emerging role of subject-researchers in biomedicine would look very different. The Gramscian theoretical apparatus would still be useful, but only to point out the great capacity for “transformism” of the dominant industrial “historical block”, which is able to mutate and inglobate patient activism and the ideological appeal of participatory discourses to its legitimizing ends.
The authors’ approach is a piece of Gramscian political economy. One key Gramscian tenet is that political economy alone does not explain social phenomena and the resilience of a given social order. Values, imaginaries and, in this case, what counts as mainstream methodology, matter as well. However, if the “patient-industry complex” hypothesis turns out to be correct, the very adoption of this Gramscian framework might have to abandoned. The Gramscian framework employed by the authors gives undue attention to “superstructural” phenomena as the clinical vs. science debate, and overlooks the crucial role of economic forces behind recent changes in biomedical innovation.
The authors point out that the role of bioethicists in the debate on stem cell regulation has been one of Gramscian “traditional intellectuals” embedded in the dominant historical block. Such intellectuals lend legitimacy to the dominant ideology, in this case supporting standards of safety and of ethical research that are entirely instrumental to the stability of the hegemony supported by the state. However, if the patient-industry complex hypothesis is true (and I cannot stress enough that whether it is true or not depends on the unfolding of phenomena that we only begin to observe), bioethicists would only be the last defence of the old order. Bioethicists would be in due time replaced by intellectuals supporting the transformism of the hegemonic historical block and its takeover of patient activism, participation and reliance on consumers’ demand.
ref 1 Brian Salter, Yinhua Zhou and Saheli Datta. 2015. Hegemony in the marketplace of biomedical innovation: Consumer demand and stem cell science.
ref 2 Laura Margottini 2013. No point in testing controversial stem cell treatment, Italian panel says.
ref 3 Vololona Rabeharisoa, Tiago Moreira, Madeleine Akrich. 2013. Evidence-based activism: Patients’ organisations, users’ and activist’s groups in knowledge society.
ref 4 Courtney Davis and John Abraham. 2013. Unhealthy pharmaceuticals. Innovation, Politics and Promissory Science.