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.

The Dobson-Rawlins pact and the National Institute for Health and Care Excellence: impact of political independence on scientific and legal accountability.

This analysis considers whether the independence of the National Institute for Health and Care Excellence (NICE), while safeguarding guidelines from commercial lobbying, may render NICE legally and scientifically unaccountable. The analysis examines the role of judicial reviews and stakeholder consultations in place of peer review in light of current debates concerning the depression guideline.

How Should a Physician Respond to a Patient's Pain When New Opioid Prescribing Laws Limit Shared Decision Making?

This commentary responds to a case and examines pragmatic concerns about operating a busy outpatient practice in compliance with new laws that regulate opioid prescribing. Specifically, the article considers how regulating opioid prescribing can influence the therapeutic alliance in patient-physician relationships and how innovations in decision science can facilitate shared decision making given time constraints.

Should a Law Governing the Pharmaceutical Market Be Ethically Examined Based on Its Intent or Its Practical Applications?

Prescription drug prices are a top health care concern among US consumers. Although this issue is at the forefront of current policy discussions, it is not new. In 1984, the Drug Pricing Competition and Patent Term Restoration Act (colloquially, the Hatch-Waxman Act) addressed drug pricing concerns. This article argues that Hatch-Waxman properly applies utilitarian principles to complex issues of biopharmaceutical development by balancing innovation and availability. However, the statute's efficacy has been marred by so-called pay-for-delay arrangements, which disrupted that carefully constructed equilibrium. This article also argues that the 2013 US Supreme Court holding in Federal Trade Commission v Actavis, Inc appropriately restored the utilitarian balance initially achieved by Hatch-Waxman.

The unsteady state and inertia of chemical regulation under the US Toxic Substances Control Act.

After 40 years, the 1976 US Toxic Substances Control Act (TSCA) was revised under the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Its original goals of protecting the public from hazardous chemicals were hindered by complex and cumbersome administrative burdens, data limitations, vulnerabilities in risk assessments, and recurring corporate lawsuits. As a result, countless chemicals were entered into commercial use without toxicological information. Few chemicals of the many identified as potential public health threats were regulated or banned. This paper explores the factors that have worked against a comprehensive and rational policy for regulating toxic chemicals and discusses whether the TSCA revisions offer greater public protection against existing and new chemicals.

Towards a genealogy of pharmacological practice.

Following Foucault's work on disciplinary power and biopolitics, this article maps an initial cartography of the research areas to be traced by a genealogy of pharmacological practice. Pharmacology, as a practical activity, refers to the creation, production and sale of drugs/medication. This work identifies five lines of research that, although often disconnected from each other, may be observed in the specialized literature: (1) pharmaceuticalization; (2) regulation of the pharmaceutical industry; (3) the political-economic structure of the pharmaceutical industry; (4) consumption/consumerism of medications; (5) and bio-knowledge. The article suggests that a systematic analysis of these areas leads one to consider pharmacological practice a sui generis apparatus of power, which reaches beyond the purely disciplinary and biopolitical levels to encompass molecular configurations, thereby giving rise not only to new types of government over life, but also to new struggles for life, extending from molecular to population-wide levels.

Mifepristone (RU486) in Australian pharmacies: the ethical and practical challenges.

OBJECTIVE: The recent legalization of mifepristone has given women in Australia a new option for termination of pregnancy. Pharmacists are well positioned to provide information and supply mifepristone for patients. However, there are ethical and legal concerns in Australia regarding the supply of mifepristone, as pharmacists may choose to conscientiously object to supplying mifepristone and are subject to differing abortion laws between states and territories in Australia. The objective of this study was to explore attitudes and knowledge of Australian pharmacists about mifepristone. STUDY DESIGN: Semistructured interviews were conducted with 41 registered pharmacists working in a pharmacy or hospital in Sydney, Australia. When data saturation was achieved, audiotaped transcripts were deidentified and transcribed verbatim. Data were thematically analyzed using a framework approach for applied policy research and categorized into the following themes: contextual, diagnostic, evaluative and strategic. RESULTS: Analysis of the transcripts yielded four themes: (a) pharmacists' contextual view on pregnancy termination, the role of the pharmacist and impact on the pharmacy workplace; (b) diagnostic reasons for differing views; (c) evaluation of actual and perceived pharmacy practice in relation to the supply of mifepristone and (d) strategies to improve pharmacists' services, awareness and education. CONCLUSION: Australian pharmacists in this study perceived themselves to have a potentially important role as medicine experts in patient health care and safety in medical termination of pregnancy. However, there was a general lack of clinical, ethical and legal knowledge about medical termination of pregnancy and its legislation. IMPLICATIONS: To ensure patient safety, well-being and autonomy, there is an imperative need for pharmacist-specific training and guidelines to be made available and open discussion to be initiated within the profession to raise awareness, in particular regarding professional accountability for full patient care.

[Legal debate about the definition of medical device and of medicinal drug for human use]. / Jogvita az orvostechnikai eszköz és a gyógyszer fogalmának értelmezésérol.

On 3 October 2013 the European Court of Justice made a decision regarding the interpretation of definitions of medical devices (Directive 93/42/EC) and medicinal product for human use (Directive 2001/83/EC), based on the Article 267 TFEU preliminary ruling. Orv. Hetil., 2014, 155(11), 429-433.

Legislative and non-legislative regulations concerning Rx drug advertisement in the European Union and the United States--comparative analysis.

Drug advertising is one of the most popular forms of communication between pharmaceutical companies and prospect drug purchasers. In the face of strong competition on the pharmaceutical market on the one hand, and patient's high susceptibility to various forms of advertising on the other, drug producers try to reach as wide group of recipients as possible. However, proper medicine use requires not only doctor's wide knowledge and experience, but also patient's awareness of necessity of rational drug usage. Advertising activities related to this group of medicines are covered by rigorous law regulations, with taking into account above-mentioned issues, and other specific features of drugs available with prescription. The aim of this article is to present legislative and non-legislative regulations concerning Rx drugs, taking into consideration law regulations that are in force in the European Union and the United States. Ethic codes implemented by drug producers associations were also used.