To what extent does the rise of the active health consumer in the globalised knowledge economy of the life sciences challenge the hegemonic model of biomedical innovation?

For many years, the orthodox model of medical innovation has been largely accepted. This model has largely assumed that new health technologies will be delivered through the ‘lengthy innovation process of basic research, clinical experimentation, product development, clinical trials, product approval and clinical application.' (Salter et al. 2015: 156). It has been disseminated as a hegemonic model through large transnational organisations who draw upon the ‘objective’ nature of the scientific method in order to gain legitimacy. This has further been sustained by the idea that health consumers have a passive role in scientific process by contributing only through clinical trials, and once the research process is complete, receiving clinical benefits.

However, as highlighted by Salter et al.(2015), the hegemonic model is increasingly being challenged, especially in the area of stem cell science. A counter-hegemonic force has developed in which consumers of scientific-unproven stem cell therapies (often called ‘stem-cell tourists’) have become more actively involved in the bio-medical innovation. These consumers are largely accepting the practice-based model, which is a direct challenge to the orthodox model. Rather than simply providing scientifically-generalisable results, the practice-based model offers benefits for the individual patient concerned.

The emergence of this counter-hegemonic force has gained the attention of hegemonic model’s traditional intellectuals, the bioethicists. They have largely supported the orthodox model of stem cell innovation, focusing more upon taking a neutral stance, rather than positively engaging with counter-hegemonic arguments. Ethical debates have thus largely revolved around the morality behind the creation and destruction of human embryonic stem cells, and how to formulate government policy in order to ensure that this area of science is able to advance. This has resulted in the global emergence of standardised policies to address such ethical concerns.

But, with the emergence of stem cell tourism, ethical concerns have shifted. Biomedical innovation has begun to take into account the demand side of the stem cell market, and thus looking at the rights of patients to seek treatment for their diseases. Gunter highlighted that ‘no entity should withhold this fundamental right unless there is a high probability of harm to the patient’ (2010: 966). The patient is finally becoming the primary focus of stem cell innovation governance with issues such as citizen rights and consumer access finally being included in clinical decisions-making.

This counter-hegemony has emerged in a field where the orthodox model has little control. Consumers are increasingly geographically mobile, and the demand-supply relationship has been dramatically reshaped due to the high accessibility of access available over the internet. The question over the next few decades is whether or not this counter-hegemony will maintain its place, and if consumer choice will continue to challenge the logic of orthodox science.

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Neoliberal Technocracy: The US FDA and Pharmacogenomics

The relaxation of regulation in pharmaceuticals has been linked to an increasing role of regulatory agencies as facilitators of innovation as opposed to simply gate-keepers. The US Food and Drug Administration has been at the debate since the beginning. A recent paper by Stuart Hogarth (drawing on the work of Williams, 2011) highlights the recent ‘innovative’ turn of the US FDA, its vision of a genomic future for pharmaceutical Research and Development in the USA and the wider neoliberal policy agenda of permissive regulation.

There have been many differing opinions on the way that the US’s pharmaceutical policy has become more neoliberal in character. On the one hand Abraham and Davis (2013) argue that there has been an emergence of ‘corporate bias theory’ in which reforms calling for less stringent regulations are pursued under the belief that patients and industry both seek less regulations and faster drug discovery processes. In contrast, Carpenter (2011) takes a pluralist perspective focussing on the impact of proposed reforms on the 'interests' of a wider group of actors ranging from specialist interest groups, civic organisations, media syndicates, corporations and wider society. As reputation management is crucial to the organisational behaviour of regulatory agencies, Carpenter suggests that by according importance to the interests of such audiences the FDA has manage to retain such power.  

The push for relaxing regulation in the US FDA can be traced to the years following tightening of FDA processes in the wake of the thalidomide crisis.  In 1962, The Kefauver Amendment to the Federal Food, Drug and Cosmetic Act (in response to the Thalidomide crisis) was enacted to tighten (i) pre-market review of safety and efficacy of every new drug candidate, (ii) through a three-phase clinical trial process, (iii) using statistical methods popularly known as Randomised Control Trials (RCTs). By the end of the 60s and 70s, these regulations were held primarily responsible for slowing the FDA's approval processes and came under considerable fire for slowing the US drug discovery pipeline compared to counterparts in other countries. In response, the Reagan administration sought to speed up US drug discovery with a ‘radical deregulatory agenda’ and in 1992 signed the Prescription Drug User Fee Act into law. The Prescription Drug User Fee Act (since amended numerous times) was intended to allow the FDA to collect feeds on human drug and biological products in order to expedite the drug approval process.

At the same time, 'deregulation' has not been without its critics. For instance, some have blamed the the Vioxx crisis (2004) as a negative fallout of FDA's deregulatory turn.  A study of the Vioxx episode by Woodcock (Clinton and Wechsler 2006) highlights the inadequacy science in general and the existing drug discovery methods in particular, to provide a credible solution to similar crises. For Woodcock, the key need is to shift away from existing statistics-dependent testing methods on broad pools of patients towards targeted clinical development on individual patients likeliest to benefit from a drug (Clinton and Wechsler, 2006). Increasingly, it is the latter 'individual patient focussed' solution -popularly called Pharmacogenomics that presents a credible drug discovery alternative as the best way if you will to ‘establish unmet medical needs, and identify patients who are predisposed to adverse events’’ (Woodcock 2011, p15).

In summary, while pharmacogenomics is often viewed as a result of the neoliberal turn for deregulation, at the same time it holds considerable promise as a better vehicle (than existing drug discovery processes) for delivering vital public goods like cheaper and faster drug development etc. 

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