Clinical trials and the origins of pharmaceutical fraud: Parke, Davis & Company, virtue epistemology, and the history of the fundamental antagonism.

This paper describes one possible origin point for fraudulent behavior within the American pharmaceutical industry. We argue that during the late nineteenth century therapeutic reformers sought to promote both laboratory science and increasingly systematized forms of clinical experiment as a new basis for therapeutic knowledge. This process was intertwined with a transformation in the ethical framework in which medical science took place, one in which monopoly status was replaced by clinical utility as the primary arbiter of pharmaceutical legitimacy. This new framework fundamentally altered the set of epistemic virtues-a phrase we draw from the philosophical field of virtue epistemology-considered necessary to conduct reliable scientific inquiry regarding drugs. In doing so, it also made possible new forms of fraud in which newly emergent epistemic virtues were violated. To make this argument, we focus on the efforts of Francis E. Stewart and George S. Davis of Parke, Davis & Company. Therapeutic reformers within the pharmaceutical industry, such as Stewart and Davis, were an important part of the broader normative and epistemic transformation we describe in that they sought to promote laboratory science and systematized clinical trials toward the twin goals of improving pharmaceutical science and promoting their own commercial interests. Yet, as we suggest, Parke, Davis & Company also serves as an example of a company that violated the very norms that Stewart and Davis helped introduce. We thus seek to describe one possible origin point for the widespread fraudulent practices that now characterize the pharmaceutical industry. We also seek to describe an origin point for why we conceptualize such practices as fraudulent in the first place.

For a honest Maghreb care system. Systematic Review of the International Literature on Corruption in the Health care System.

INTRODUCTION: Corruption in the health care system is a universal phenomenon, putting at risk the health of populations. The purpose of this work was to synthesize the international literature on corruption in the health sector. METHODS: This is a systematic review of literature dealing with articles on health corruption practices, published between July 2008 and June 2018, via two search engines: PubMed and Google Scholar. The extracted data were narratively summarized in three major areas: defining the concept of corruption in health, its typology / manifestations and anti-corruption interventions. RESULTS: A total of 23 articles were selected for final analysis. The articles that defined health corruption shared two key aspects: "abuse of power" and "benefit". The main types of corruption were "abuse of therapeutic indication", followed by "bribes" and "falsification". The anti-corruption interventions were synthesized into seven types: creation of an independent multi-interventional agency, support for scientific research, law enforcement, awareness raising, detection, reporting and institutional commitment. CONCLUSION: Based on the use of power, corruption in health is a complex phenomenon whose struggle requires a specific and contextualized strategy integrating information, detection and punishment.

The need to train uncertified rural practitioners in India.

Uncertified rural practitioners (URPs) without formal medical qualification occupy an indispensable yet dangerous position in the rural health care system in India. The low cost, close proximity, and higher health hazards in rural areas along with the inability of established health-care setups to fulfill existing demands have favored the flourishing trade of URPs. Irrational and dangerous drug prescriptions, unauthorized interventions, improper waste disposal, and several cases of malpractice by URPs are serious threats to the exposed population. However, because of the practical compulsion and real-world necessity of their existence, URPs should be scientifically trained and sensitized to regulate, qualify, and integrate them as a part of the existing health care system in India.

The Medical Battery in The United States (1870-1920): Electrotherapy at Home and in the Clinic.

This paper focuses on the history of a portable shock-producing electrotherapeutic device known as the medical battery (1870-1920), which provided both direct and alternating current and was thought to cure a wide variety of ailments. The product occupied a unique space at the nexus of medicine, consumerism and quackery: it was simultaneously considered a legitimate device by medical professionals who practiced electrotherapeutics, yet identical versions were sold directly to consumers, often via newspaper advertisements and with cure-all marketing language. Indeed, as I show in this paper, the line between what was considered a medical device and a consumer product was often blurred. Even though medical textbooks and journals never mentioned (much less promoted) the home use of electricity, every reputable electrotherapy instrument manufacturer sold a "family battery" for patients to use on themselves at home. While a handful of physicians spoke out against the use of electricity by the laity-as they felt it undermined the image of electrotherapy as a skilled medical procedure-existing evidence suggests that many physicians were likely recommending the home use of medical electricity to their patients. Taken together, this paper shows how the professional ideals of electrotherapeutics were not always aligned with physicians' actual practices.

Popular Medicine and Empirics in Greece, 1900-1950: An Oral History Approach.

Western literature has focused on medical plurality but also on the pervasive existence of quacks who managed to survive from at least the eighteenth to the twentieth century. Focal points of their practices have been their efforts at enrichment and their extensive advertising. In Greece, empirical, untrained healers in the first half of the twentieth century do not fit in with this picture. They did not ask for payment, although they did accept 'gifts'; they did not advertise their practice; and they had fixed places of residence. Licensed physicians did not undertake a concerted attack against them, as happened in the West against the quacks, and neither did the state. In this paper, it is argued that both the protection offered by their localities to resident popular healers and the healers' lack of demand for monetary payment were jointly responsible for the lack of prosecutions of popular healers. Moreover, the linking of popular medicine with ancient traditions, as put forward by influential folklore studies, also reduced the likelihood of an aggressive discourse against the popular healers. Although the Greek situation in the early twentieth century contrasts with the historiography on quacks, it is much more in line with that on wise women and cunning-folk. It is thus the identification of these groups of healers in Greece and elsewhere, mostly through the use of oral histories but also through folklore studies, that reveals a different story from that of the aggressive discourse of medical men against quacks.

Origins of the prohibition against off-label promotion.

The statute and regulations administered by the Food and Drug Administration ("FDA") do not explicitly prohibit the promotion of drugs and medical devices for unapproved uses, yet the government has collected billions of dollars in penalties for such "off-label" promotion. The statutory interpretations and regulatory provisions relied on by the government to take enforcement action against off-label promotion are the incidental by-products of initiatives undertaken by FDA through administrative action and litigation early in its implementation of the Federal Food, Drug, and Cosmetic Act. The actions were designed to obtain FDA authority over therapeutic claims made in advertising, even though Congress had assigned authority over advertising to the Federal Trade Commission, and to establish a prescription-only drug system, even though FDA lacked statutory authority for such a system. The principal purpose of both efforts was to prevent inappropriate self-medication. This article describes the history of those strategies, including expansion of the definition of the term "labeling" to encompass matter that was initially regarded as advertising; creation of the rule that the labeling of drugs must have adequate directions for all "intended" uses; and construction of the prescription-only drug system in a manner that allowed FDA to use the statutory requirement for labeling to have "adequate directions for use" to prohibit the off-label promotion of prescription drugs.