The past few years have witnessed several media-covered cases involving citizens actively engaging in the pursuit of experimental treatments for their medical conditions—or those of their loved ones—in the absence of established standards of therapy. This phenomenon is particularly observable in patients with rare genetic diseases, as the development of effective therapies for these disorders is hindered by the limited profitability and market value of pharmaceutical research. Sociotechnical trends at the cross-section of medicine and society are facilitating the involvement of (...) patients and creating the digital infrastructure necessary to its sustainment. Such participant-led research has the potential to promote the autonomy of research participants as drivers of discovery and to open novel non-canonical avenues of scientific research. At the same time, however, the extra-institutional, self-appointed, and, often, oversight-free nature of PLR raises ethical concern. This paper explores the complex ethical entanglement of PLR by critically appraising case studies and discussing the conditions for its moral justification. Furthermore, we propose a path forward to ensure the safe and effective implementation of PLR within the current research ecosystem in a manner that maximizes the benefits for both individual participants and society at large, while minimizing the risks. (shrink)

Pharmaceutical industry funding has transformed much grassroots community activism on health into corporate-sponsored advocacy. This critical commentary outlines recent evidence about industry funding of patient advocacy groups, offers a commentary on the history of grassroots activism appearing in this issue of the journal, and calls for greater scrutiny of the impacts and ethics of such sponsorship.

ObjectiveTo identify the ethical challenges associated with the development and implementation of new tuberculosis drugs and diagnostics.MethodsTwenty-three semi-structured qualitative interviews conducted between December 2015 and September 2016 with programme administrators, healthcare workers, advocates, policymakers, and funders based in the Americas, Europe, and Africa. Interviews were analysed using thematic analysis.ResultsDivergent interests and responsibilities, coupled with power imbalances, are a primary source of ethical challenges; the uncertain risk profiles of new drugs present an additional one. Although this challenge can be partially mitigated (...) through stringent pharmacovigilance, respondents highlighted that high-burden countries tend to lack the resources to facilitate safe implementation. Increased advocacy and community engagement are considered an ethical imperative for future TB development and implementation.ConclusionsThis project helps identify some of the ethical challenges of new TB technologies. It demonstrates that investigating ethical challenges through qualitative research is one way to apprehend the difficulty of implementing new TB technologies. Addressing this difficulty will require that those in positions of power reconsider their interests in relation to disempowered communities.Policy implicationsEfforts to build consensus regarding what values should underpin the global governance of TB research, prevention, and care are essential to facilitate the ethical implementation of new TB technologies. (shrink)

Consumer engagement in decisions about the funding of medicines is often framed as a good in and of itself and as an activity that should be universally encouraged. A common justification for calls for consumer engagement is that it enhances equity. In this paper we systematically critique this assumption. We show that consumer engagement may undermine equity as well as enhance it and show that a simple relationship cannot be assumed but must be justified and demonstrated. In concluding, we present (...) a number of challenges that need to be overcome in order for consumer engagement to contribute to health technology assessment in a morally and politically sound manner. (shrink)

The high price of drugs is receiving due consideration from ethicists, policymakers, and legislators. However, much of this attention has focused on the difference between the cost of drug development and company profits and the possible laws and regulations that could limit a drug’s price once it reaches market. By contrast, little attention has been paid to the ethical implications of high drug prices for the research subjects whose bodies were essential to the drug’s development. Indeed, the future price of (...) a drug is routinely ignored and treated as unknowable during the ethical evaluation of the clinical trials that support its development. In this paper, I will argue that ignoring the future price of a drug during the research process is in tension with all three of the major principles of research ethics: it fails to show respect for the research participants, undermines the quality of risk/benefit judgements made by ethical review committees, and makes it impossible to judge future patient access and assess justice. (shrink)

Women’s health activists laid the groundwork for passage of the law that created the U.S. Food and Drug Administration in 1906. The pharmaceutical and food industries fought regulatory reforms then and continue to do so now. We examine public health activism in the Progressive Era, the postwar era and the present day. The women’s health movement began in the 1960s, and criticized both the pharmaceutical industry and the medical establishment. In the 1990s, patient advocacy groups began accepting industry funds; thousands (...) of commercially-funded groups now dominate the advocacy landscape. As pharma funding became normalized, concerns arose regarding a) the lack of transparency and public accountability regarding funding, b) the distortion of groups’ agendas, and c) the ability of pharma-funded groups to dominate the discourse and override less well-resourced patient and health advocacy groups. Although industry-funded groups argue that funding allows them to provide useful services, the trade-off in health risks, exorbitant prices and distorted information is far too high. Sincerity is beside the point; patients and the industry have differing interests when it comes to drug safety and efficacy, drug information and drug prices. A growing resistance movement is asserting the values of its activist predecessors and opposing the prevailing culture of pharma-funded advocacy. (shrink)