The controversy over the prescription drug, alosetron, is examined in order to investigate what is permitted to count as ‘therapeutic advance’ and ‘therapeutic breakthrough’ within pharmaceutical innovation and regulation. It is argued that those official accounting categories can mask very modest efficacy of some drugs by reference to the official techno-scientific evidence, thus leading to questionable acceptance of risks to public health. This is explained by: the drug availability options set by the commercial interests of manufacturers; the FDA management's need (...) to demonstrate rapid approval of therapeutic advances to their budgetary masters, especially in the context of patient demands for access to new drugs; and the increasing capacity of patient groups, sometimes in collaboration with pharmaceutical manufacturers, to challenge techno-scientific expertise and evidence with experiential testimony. It is concluded that regulatory policy-makers need much more sophisticated accounting systems for differentiating between drugs defined as significant therapeutic advances, and between drugs (‘therapeutic breakthroughs’ fast-tracked to treat serious or life-threatening conditions. Contrary to some STS analyses, the desirability of an ascendancy of patients’ anecdotal evidence in regulatory decisions for public health is questioned. (shrink)

Over the past 35 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits. The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created. Since 1906, heavy commercial influence has compromised congressional legislation to protect the public from unsafe drugs. The authorization of user fees in 1992 has turned drug companies into the FDA's (...) prime clients, deepening the regulatory and cultural capture of the agency. Industry has demanded shorter average review times and, with less time to thoroughly review evidence, increased hospitalizations and deaths have resulted. Meeting the needs of the drug companies has taken priority over meeting the needs of patients. Unless this corruption of regulatory intent is reversed, the situation will continue to deteriorate. We offer practical suggestions including: separating the funding of clinical trials from their conduct, analysis, and publication; independent FDA leadership; full public funding for all FDA activities; measures to discourage R&D on drugs with few, if any, new clinical benefits; and the creation of a National Drug Safety Board. (shrink)

Few empirical studies have explored how different types of knowledge are associated with diverse objectivities and moral economies. Here, we examine these associations through an empirical investigation of the public policy debate in Israel around medical cannabis, which may be termed a contested medicine because its therapeutic effects, while subjectively felt by users, are not generally recognized by the medical profession. Our findings indicate that beneath the MC debate lie deep-seated issues of epistemology, which are entwined with questions of ethics (...) and morality. Whereas some stakeholder groups viewed evidence-based medicine and mechanical objectivity as the only valid knowledge base, others called for recognition of a particular experience-based knowledge, championing regulatory, administrative, or strong objectivity. Stakeholders’ interpretations of what should be considered as ethical courses of action corresponded to their epistemological views, with most criticizing the regulators for relying on regulatory subjectivity instead of objectivity. Our in-depth mapping of this arena allowed us not only to shed light on the emergence of the new entity called “medical cannabis” but also to reexamine the link between epistemology, ethics, and action and to elucidate how heterogeneous groups view the validity and objectivity of knowledge and the interface between medicine, science, and policy. (shrink)

Institutional corruption is a normative concept of growing importance that embodies the systemic dependencies and informal practices that distort an institution’s societal mission. An extensive range of studies and lawsuits already documents strategies by which pharmaceutical companies hide, ignore, or misrepresent evidence about new drugs; distort the medical literature; and misrepresent products to prescribing physicians. We focus on the consequences for patients: millions of adverse reactions. After defining institutional corruption, we focus on evidence that it lies behind the epidemic of (...) harms and the paucity of benefits. (shrink)

Scholars in science and technology studies, as well as economics and innovation studies, utilize the trajectory metaphor in describing a technology’s maturation. Impetus and purpose may differ, but the trajectory serves as a shared tool for assessing social change either in society at large or within a market sector, a firm, or a discipline. In reverse, the lens of a technology trajectory can be a basis for assessing technology, estimating economic growth, and selecting among plausible product development pathways. Emerging technologies (...) pose a challenge in that the promissory claims that attracted investment may also challenge social safeguards, leading to necessary, but unforeseen hurdles to later technology acceptance. The experiences with biotechnology and nanotechnology demonstrate that knowledge gained in the intervening years was to have tempered exaggerations and addressed the criteria and the responsibilities of those who would later be deciding on product acceptability. In particular, the promissory claim for nanotechnology, unique phenomena, challenged regulatory practice, while claims for biotechnology products were often the fruition of themes found in the educational experience common to both the biotechnology researcher and the regulator. The social science and humanities literature mirrored these points as did the responses of civil society organizations. A prospective trajectory for artificial intelligence is developed using the example of driverless cars and then qualitatively compared to the retrospective trajectories for nanotechnology and biotechnology. Experience with automation, algorithm transparency, and computational modeling of biological mechanisms are identified as pertinent to responsible AI development. (shrink)

It is argued that neoliberal political ideology has redefined the regulatory state to have greater convergence of interests and goals with the pharmaceutical industry than previously, particularly regarding acceleration and cost reduction of drug development and regulatory review. Consequently, the pharmaceutical industry has been permitted to set the agenda about how shorter term and cheaper alternative carcinogenicity testing systems are investigated for validity. The authors contend that, with the tacit approval of the neoliberal regulatory state, the commercial interests of the (...) pharmaceutical industry framed the process and interpretation of validating these new test systems, thereby influencing what counts as knowledge about the carcinogenic status of new pharmaceuticals. While such alternative tests were occasioned by “molecularization,” the framing of their validation was not determined by technoscientific logic or a lack of standards of validation, but by the sociopolitical goals of the controlling institutions. Indeed, a different validation process could have been conducted had the priority been to develop carcinogenicity testing in the interests of public-health protection. While the resulting validation indicated that the short-term alternative tests posed small risks to the commercial interests of pharmaceutical firms, they provided little reassurance that patients would not be exposed to greater risks than before from undetected carcinogens. (shrink)

The article analyses what we term governmental ethics regimes as forms of scientific governance. Drawing from empirical research on governmental ethics regimes in Germany, Franceand the UK since the early 1980s, it argues that these governmental ethics regimes grew out of the technical model of scientific governance, but have departed from it in crucial ways. It asks whether ethics regimes can be understood as new ‘‘technologies of humility’’ and answers the question with a ‘‘yes, but’’. Yes, governmental ethics regimes have (...) incorporated features that go beyond technologies of prediction and control, but the overcoming of the technical model also bears some ambivalence that needs to be understood. The article argues that governmental ethics regimes can be understood as a form of ‘‘reflexive government’’ in that the commitment to techno-scientific innovation is stabilized not through an elitist, technocratic exclusion of non-scientific actors and knowledges or a depreciation of normative and emotional dimensions, but through their inclusion, involvement and mobilization. (shrink)

This article examines the way in which public controversies affect regulatory science. It describes the controversy that unfolded in Europe around the use of the ninety-day rat-feeding tests for the risk assessment of genetically modified plants. This type of test had been criticized for almost two decades by toxicologists, nongovernmental organizations, and industry alike for its inability to capture the specific health effects of GM plants. But GM risk assessment experts showed great reluctance to move toward a more systematic use (...) of other tests, such as chronic two-year studies or toxicogenomic techniques, and made sure that official guidance continues to recommend the use of the ninety-day rat-feeding study. The article shows that these tactics of standardization are a defining feature of regulatory science, and a resource for toxicity experts to defend their authority and credibility against competing expertises that arise during controversies. (shrink)

Medicines regulators have generally adopted a scientistic view of medicines evaluation, which they present as an exercise that should—and indeed can—be purely “objective,” based only on knowledge produced through validated research protocols. The growing body of social science literature analyzing the regulation of medicines has questioned this pretense of objectivity and underlined the socio-political construction of evidence on the risks and benefits of medicines. But while the European Medicines Agency has become the dominant regulatory body in Europe and a key (...) player at world level, very few studies have investigated its actual practices. Based on interviews with European regulators, but also on direct observations of several meetings of the European Medicines Agency’s main expert committee, this article aims to analyze how regulatory knowledge is defined and then transformed into regulatory decisions. First, it describes the main characteristics of European medicines regulation and the historical definition of what can count as “objective” evidence on the safety and efficacy of medicines. Second, it demonstrates that experts use many different types of knowledge in building their opinions: the results of studies, but also knowledge about firms’ past and present strategies, about patients’ needs and future behavior, about the state of research and clinical practices, and about legal and policy-making issues. Third, it explains why, in spite of the various forms of knowledge involved, experts manage to produce consensual opinions on medicines and why these opinions are considered genuine decisions in the sector. (shrink)