Drug Regulation

O presente trabalho busca realizar um estudo de caso do modelo uruguaio de regulação do mercado da maconha com controle estatal, como uma alternativa ao paradigma proibidor de controle das drogas consideradas ilícitas. Em vista do notável crescimento do movimento antiproibicionista na última década na América Latina e também a nível global, a presente pesquisa procura identificar as condições de possibilidade que permitiram que a Lei nº 19.172, de Regulação e Controle do Mercado da cannabis, fosse desenvolvida, proposta, aprovada e implementada no Uruguai. Assim, a investigação objetiva, com fundamento nas sociologia, ciência política e história do país, compreender quais foram os antecedentes que possibilitaram ao Uruguai esta posição de vanguarda na adoção de políticas progressistas. Deste modo, os antecedentes a longo prazo correspondem às reformas desenvolvidas no país, nas primeiras décadas do século XX, no período conhecido como batllismo, as quais foram responsáveis pela construção dos pilares que sustentam a atual matriz cidadã moderna uruguaia, com o fortalecimento de sua democracia e de seu sistema de partidos. Os antecedentes a curto prazo são apresentados através da chegada da Frente Ampla à Presidência Nacional em 2005, que marcou o início de la era progresista no Uruguai, com sua consagração a partir do mandato presidencial de Pepe Mujica, em vista da significativa expansão da agenda governamental em matéria de direitos civis, tendo como principais: a legalização do casamento igualitário, a descriminalização do aborto e a regulação do mercado da maconha, objeto desta pesquisa. A parte empírica deste trabalho, através da realização de entrevistas semiestruturadas com atores uruguaios de diversas áreas, fundamentais para o desenvolvimento do modelo de regulação, pretende apresentar como foi construído o caminho até a lei de regulação, assim como quais são as perspectivas dos informantes acerca do modelo e suas expectativas com a nova política de drogas desenvolvida pelo país em relação à cannabis.

O artigo descreve o funcionamento das salas de consumo assistido de drogas, cujo público-alvo
são os usuários em maior situação de vulnerabilidade social e para os quais se disponibiliza um
local com higiene adequada e assistido por profissionais qualificados a fim de reduzir a
mortalidade e a morbidade decorrentes do uso de substâncias psicoativas. O artigo também
problematiza se as cenas de consumo de drogas poderiam prover serviços similares aos das salas
de consumo assistido, tornando-se assim cenas de consumo assistido, com a devida
regulamentação. Defende, por fim, a importância dos Estados e Municípios na regulação sanitária
local e apresenta uma interpretação sobre a lei de Drogas que sustenta um papel mais ativo destes
entes federativos na regulação do tema, retirando a tradicional centralidade da União na Política
de Drogas.

El presente memorando resume las conclusiones de un análisis en profundidad anterior, titulado “Análisis de Proyecto de Ley: La conveniencia de regular el mercado de cannabis en Uruguay” (Sanjurjo, 2013)1. El mismo hace uso de la información y evidencia científica disponible para proyectar las posibles resultados y consecuencias de la propuesta regulatoria en el corto, mediano y largo plazo. La comparación con la evolución esperada de los daños del problema bajo el antiguo régimen semi-prohibicionista permite concluir que la implementación de un régimen regulatorio del mercado de cannabis puede suponer, a mediano y largo plazo, una respuesta más adecuada a los daños, perjuicios y pérdidas que componen el problema. No obstante, esta conclusión principal está firmemente supeditada a la efectiva implementación de políticas de educación e información, que ayuden a aumentar la percepción de riesgo de consumo de la sustancia.

Phage therapy, the use of bacteriophage viruses to treat bacterial infections, has existed for more than a hundred years. However, the practice is struggling to develop, despite growing support over the past 15 years from researchers and doctors, who see it as a promising therapy in the context of the rise of antimicrobial resistance (AMR). While the reasons for these developmental difficulties are complex, in this article we wish to address the effects of pharmaceutical regulations on phage therapy. By showing how phages are assimilated to an umpteenth antibiotic in legal texts, but also in certain medical practices, this article proposes to analyze the consequences of such regulatory categorization both for their production and the logistics of administration of proof of their efficacy in randomized controlled trials (RCTs), as well as the underlying concepts of infection and treatment. This paper follows Chandler’s work on the concept of antibiotics as infrastructure and its inversion presented by antimicrobial resistance. Phages as living, dynamic, evolving, and specific entities, do not lend themselves easily to current categories, norms, and development models. In this sense, they act as disruptors, revealing the limitations imposed by the existing infrastructure. More precisely here, and to continue Chandler’s initial thought process, this paper aims to show that antibiotics also form a kind of epistemological infrastructure, which acts as a powerful inhibitor to the development of phage therapy. In this sense antibiotics prevent the development of solutions to the problem they contribute to create. But the difficulties phage therapy faces, as highlighted in this article, can be interpreted as entry points for thinking of another medicine and imagining other possible futures. This analysis is based on a 3-year fieldwork study (2016–2019) in Europe (France, Belgium, and Switzerland), during which we conducted semi-directed interviews with various phage therapy stakeholders (physicians, researchers, pharmacists, regulators, patients, and patient associations), participatory observation in labs and observations during symposia and workshops on phages and phage therapy.

This article examines the origins of state-level regulations controlling the practice of pharmacy and the manufacture and consumption of dangerous drugs in the Gilded Age. I argue that the passage of laws regulating the market in pharmaceuticals grew out of both the precarious economic position of practicing pharmacists and widespread concern for the suffering of individual consumers. As a result, pharmacy laws and other regulations controlling the buying, selling, and use of dangerous drugs during this period should be understood as part of the effort by pharmacists to establish a professional identity for themselves. At the same time, these laws  should also be understood as part of the process through which reformers sought to rationalize society toward the goal of protecting the individual consumer. Ironically, however, such efforts were intertwined with the bifurcation of consumer culture into legitimate and illegitimate realms and with it the creation of the economic and social conditions in which new stories of individual suffering took place.

This article explores the criminal regulation of misoprostol as a controlled drug in Brazil as a new form of abortion criminalization. A qualitative analysis of Brazilian case law shows how the courts use a public health rhetoric of unsafe abortion to criminalize the distribution of misoprostol in the informal sector. Rather than an invention of the local bench, this judicial rhetoric reflects global public health discourse and policy on unsafe abortion and the double life of misoprostol as both an essential medicine and a controlled drug. In contrast to previous studies, the article shows that abortion criminalization is not the cause, but rather the consequence of misoprostol’s double life. In the last section, it draws on an outlier judgment of the case law to chart a regulatory future for misoprostol and its supply in the informal sector as a site of harm reduction and safe abortion in public health policy.

Revue d'anthropologie des connaissances 15-3 | 2021 Un tournant microbien ? Évolutions et involutions dans la biomédecine Thérapie phagique et traitement des infections bactériennes antibiorésistantes Evolutions and involutions in biomedicine. Phage therapy and the treatment of antibiotic-resistant bacterial infections Evoluciones e involuciones en biomedicine. Fagoterapia y tratamiento de infecciones bacterianas resistentes a los antibióticos

Le système international de contrôle des drogues repose sur la limitation de la circulation des drogues au champ médico-scientifique. Cet article analyse les conditions d’implantation et de stabilisation de ce champ au Brésil entre les années 1920 et 1950 au travers du prisme de la commission chargée de contrôler les drogues au Brésil (Comissão Nacional de Fiscalização de Entorpecentes). Il analyse les processus d’inclusion et d’exclusion qui sont liés à la délimitation de ce champ et revient sur cette période dans laquelle les mesures du contrôle des stupéfiants visaient avant tout ceux qui étaient leurs distributeurs légitimes : les professionnels et établissements de santé.

Nature or nurture? To what extent genetics play a role in drug efficacy and safety? These questions are not new. They are however gaining increasing prominence with the implementation of pharmacogenomics in various facets of medicine ranging from therapeutics, drug development and regulatory science to research funding decisions. For predisposition to common complex diseases, twin and family studies have been the mainstay for estimating genetic components of the attendant risk. On the other hand, the rapid pace of drug development in the pharmaceutical industry and the need for faster regulatory decisions call for an approach of higher throughput to identify the compounds for which heritability is likely to play a significant role in their pharmacokinetics and/or pharmacodynamics. A second predicament related to multifactorial nature of drug effects is that one typically observes a considerable overlap in the distribution of drug response phenotypes among subpopulations identified by each pharmacogenomic biomarker. This is in sharp contrast to monogenic pharmacological traits wherein it is feasible to partition the patient populations into discrete subgroups by analysis of a single gene. Hence, as pharmacogenomic investigations progress from monogenic to increasingly multigenic or multifactorial drug response phenotypes, the regulatory decision-makers are faced with a dilemma: How can a reviewer or a clinician determine if a given separation of a drug response profile by a pharmacogenomic biomarker is worthwhile for clinical implementation? The present manuscript makes an attempt to address these broad and emerging issues in pharmacogenomics and regulatory science. We propose that a comparison of inter- versus intra-subject variability in drug response under minimal environmental exposure may provide an upper- bound estimate of heritability of drug efficacy and safety. It is also argued that seemingly modest changes in population averages may underestimate the dramatic impact of a genetic biomarker at the tails of a population. To this end, a conceptual framework for graded risk assessment among subpopulations with overlapping quantitative phenotypes is presented. We conclude with a broader discussion of the evolution of genetic biomarkers from monogenic to multigenic traits in pharmacology, the associated ethical, social and therapeutic policy corollaries and the challenges lying ahead.

This paper is the translation of an article published in French in the Revue d'Anthropologie des Connaissances, "Evolutions et involutions dans la biomédecine, thérapie phagique et traitement des infections bactériennes antibiorésistantes ", 15(3). https://journals.openedition.org/rac/24239 Evolutions and involutions in biomedicine. Phage therapy and treatment of antibiotic-resistant bacterial infections

Patient access to experimental drugs outside of clinical trials is called compassionate use or expanded access.  Compassionate use/expanded access presents a powerful ethical dilemma in that it involves competing claims that both have moral weight: specifically, an individual patient’s very understandable
desire to try to extend his or her life versus the orderly and efficient functioning of a drug development and clinical trial system that benefits much larger numbers of patients.  Patient advocates, the FDA, pharmaceutical trade groups, and state and national legislators in the US are all currently weighing in on patient access to experimental drugs, and new guidelines and rules are being introduced.  In this editorial, we discuss the impulse to rescue individual patients facing dire diseases and underscore the ethical questions that such rescue efforts raise.

Phage therapy, the use of bacteriophage viruses to treat bacterial infections, has existed for more than a hundred years. However, the practice is struggling to develop, despite growing support over the past 15 years from researchers and doctors, who see it as a promising therapy in the context of the rise of antimicrobial resistance (AMR). While the reasons for these developmental difficulties are complex, in this article we wish to address the effects of pharmaceutical regulations on phage therapy. By showing how phages are assimilated to an umpteenth antibiotic in legal texts, but also in certain medical practices, this article proposes to analyze the consequences of such regulatory categorization both for their production and the logistics of administration of proof of their efficacy in randomized controlled trials (RCTs), as well as the underlying concepts of infection and treatment. This paper follows Chandler's work on the concept of antibiotics as infrastructure and its ...

In January 1996, following the decision of the Food and Drug Administration (FDA), Health Canada (HC) approved OxyContin (an opioid) for the treatment of chronic pain. HC stated at the time of approval, in the drug’s product monograph (used to inform medical professionals about the safety and appropriate use of the drug), that OxyContin was safe and effective for chronic pain with low abuse potential. However, during the late 1990s and early 2000s, growth in the use of OxyContin was accompanied by widespread reports of addiction, abuse and deaths (GAO, 2003). This prompted the FDA, in 2001, to change the label of OxyContin, strengthening the warning (adding a “black box warning” to the drug packaging) regarding the drug’s abuse liability and risk of addiction. HC, based on available evidence at that time, believed the problem of OxyContin was limited to the United States and decided not to change the product monograph (Sullivan, 2001). Only in 2006, did HC change the OxyContin monograph, strengthening the warning of OxyContin abuse. Drawing on philosophical discussions of inductive risk (Douglas, 2000, 2009; Rudner, 1953), we investigate the ethical obligation of HC to revise and change the original product monograph of OxyContin. We examine how much evidence—and what kind of evidence—should be sufficient for the agency to act.
Evidence shows that Purdue Pharma (manufacturer of OxyContin)—knowing that physicians routinely view drugs monographs to learn about drugs’ efficacy and proper use—used the erroneous information, as it appeared on the monograph, as a principle selling point to influence physicians to increase prescribing (Meier, 2018). By 2001, OxyContin had become the most frequently prescribed narcotic drug in the United States for treating moderate to severe pain (GAO, 2003). A steep increase in opioid prescriptions, with OxyContin at the center of the problem, was the gateway to the opioid epidemic. Many individuals who developed opioid dependency eventually turned to cheaper or more potent street drugs, including heroin or synthetic opioids such as fentanyl. High rates of addiction, overdose, and death make the opioid epidemic one of the most urgent public health issues in the Canada, with nearly 4,000 opioid-related deaths in 2017 (Health Canada, 2018).
We approach the ethics of this issue from the perspective of the argument from inductive risk. According to this argument, value judgments about how bad an error would be in a moral sense are relevant to deciding what should count as sufficient evidence for asserting a claim (Douglas, 2000, 2009; Rudner, 1953). In this case, we argue that a consideration of inductive risks would have supported taking lower quality evidence as sufficient for revising the product monograph. In fact, Health Canada did the opposite, and demanded stronger evidence than it normally requires. Thus, we recommend that inductive risks be explicitly considered in future cases.