The realities of Medical Assistance in Dying in Canada.

OBJECTIVES: To examine the impact of the Canadian MAiD program and analyze its safeguards. METHODS: A working group of physicians from diverse practice backgrounds and a legal expert, several with bioethics expertise, reviewed Canadian MAiD data and case reports. Grey literature was also considered, including fact-checked and reliable Canadian mainstream newspapers and parliamentary committee hearings considering the expansion of MAiD. RESULTS: Several scientific studies and reviews, provincial and correctional system authorities have identified issues with MAiD practice. As well, there is a growing accumulation of narrative accounts detailing people getting MAiD due to suffering associated with a lack of access to medical, disability, and social support. SIGNIFICANCE OF RESULTS: The Canadian MAiD regime is lacking the safeguards, data collection, and oversight necessary to protect Canadians against premature death. The authors have identified these policy gaps and used MAiD cases to illustrate these findings.

Authorship controversies in academic publication: implications for science and the research environment.

The inspiration for this theme issue came from one of the biggest challenges that the journal has faced since its inception.

The unintended consequences of COVID-19 vaccine policy: why mandates, passports and restrictions may cause more harm than good.

Vaccination policies have shifted dramatically during COVID-19 with the rapid emergence of population-wide vaccine mandates, domestic vaccine passports and differential restrictions based on vaccination status. While these policies have prompted ethical, scientific, practical, legal and political debate, there has been limited evaluation of their potential unintended consequences. Here, we outline a comprehensive set of hypotheses for why these policies may ultimately be counterproductive and harmful. Our framework considers four domains: (1) behavioural psychology, (2) politics and law, (3) socioeconomics, and (4) the integrity of science and public health. While current vaccines appear to have had a significant impact on decreasing COVID-19-related morbidity and mortality burdens, we argue that current mandatory vaccine policies are scientifically questionable and are likely to cause more societal harm than good. Restricting people's access to work, education, public transport and social life based on COVID-19 vaccination status impinges on human rights, promotes stigma and social polarisation, and adversely affects health and well-being. Current policies may lead to a widening of health and economic inequalities, detrimental long-term impacts on trust in government and scientific institutions, and reduce the uptake of future public health measures, including COVID-19 vaccines as well as routine immunisations. Mandating vaccination is one of the most powerful interventions in public health and should be used sparingly and carefully to uphold ethical norms and trust in institutions. We argue that current COVID-19 vaccine policies should be re-evaluated in light of the negative consequences that we outline. Leveraging empowering strategies based on trust and public consultation, and improving healthcare services and infrastructure, represent a more sustainable approach to optimising COVID-19 vaccination programmes and, more broadly, the health and well-being of the public.

COVID-19 vaccine boosters for young adults: a risk benefit assessment and ethical analysis of mandate policies at universities.

In 2022, students at North American universities with third-dose COVID-19 vaccine mandates risk disenrolment if unvaccinated. To assess the appropriateness of booster mandates in this age group, we combine empirical risk-benefit assessment and ethical analysis. To prevent one COVID-19 hospitalisation over a 6-month period, we estimate that 31 207-42 836 young adults aged 18-29 years must receive a third mRNA vaccine. Booster mandates in young adults are expected to cause a net harm: per COVID-19 hospitalisation prevented, we anticipate at least 18.5 serious adverse events from mRNA vaccines, including 1.5-4.6 booster-associated myopericarditis cases in males (typically requiring hospitalisation). We also anticipate 1430-4626 cases of grade ≥3 reactogenicity interfering with daily activities (although typically not requiring hospitalisation). University booster mandates are unethical because they: (1) are not based on an updated (Omicron era) stratified risk-benefit assessment for this age group; (2) may result in a net harm to healthy young adults; (3) are not proportionate: expected harms are not outweighed by public health benefits given modest and transient effectiveness of vaccines against transmission; (4) violate the reciprocity principle because serious vaccine-related harms are not reliably compensated due to gaps in vaccine injury schemes; and (5) may result in wider social harms. We consider counterarguments including efforts to increase safety on campus but find these are fraught with limitations and little scientific support. Finally, we discuss the policy relevance of our analysis for primary series COVID-19 vaccine mandates.

Regulators, Pivotal Clinical Trials, and Drug Regulation in the Age of COVID-19.

Medicine regulators rely on pivotal clinical trials to make decisions about approving a new drug, but little is known about how they judge whether pivotal trials justify the approval of new drugs. We explore this issue by looking at the positions of 3 major regulators: the European Medicines Agency, Food and Drug Administration, and Health Canada. Here we report their views and the implications of those views for the approval process. On various points, the 3 regulators are ambiguous, consistent, and demonstrate flexibility. The range of views may well reflect different regulatory cultures. Although clinical trial information from pivotal trials is becoming more available, regulators are still reluctant to provide detailed information about how that information is interpreted. As medicines and vaccines come up for approval for treatment of COVID-19, transparency in how pivotal trials are interpreted will be critical in determining how these treatments should be used.

Transparencia sobre los ensayos clínicos en la Región de las Américas: necesidad de coordinar las esferas regulatorias

[EXTRACTO]. En su Política de investigación para la salud del 2009, la Organización Panamericana de la Salud/Organización Mundial de la Salud (OPS/OMS) reiteró el papel clave que desempeña la transparencia a la hora de asegurar que la investigación para la salud sea fiable. Tras varias controversias notorias, se ha promovido la transparencia especialmente en el contexto de los ensayos de productos farmacéuticos patrocinados por la industria, destinados a proporcionar datos para obtener la autorización de medicamentos por parte de las autoridades regulatorias. En respuesta a estas controversias, diversos interesados directos han presionado para lograr que haya un registro de los ensayos clínicos y acceso a los datos presentados a los organismos de regulación farmacéutica como herramientas clave de transparencia, con objeto de potenciar la toma de decisiones basadas en la evidencia por parte de los médicos clínicos, las autoridades regulatorias y la sociedad...

[EXTRACTO]. Na sua Política de Pesquisa para a Saúde de 2009, a Organização Pan-Americana da Saúde/Organização Mundial da Saúde (OPAS/OMS) reiterou o papel fundamental da transparência para como fator garantidor de confiabilidade das pesquisas em saúde. Na esteira de várias ocorrências altamente controversas, tem-se promovido cada vez mais a transparência, especialmente no contexto de pesquisas farmacêuticas patrocinadas pela indústria com o objetivo de produzir dados para a aprovação de medicamentos pelas autoridades reguladoras. Em resposta a essas controvérsias, vários interessados diretos preconizaram o registro de ensaios clínicos e o acesso aos dados submetidos às agências reguladoras de medicamentos como ferramentas essenciais de transparência, visando melhorar a tomada de decisões informadas por clínicos, pelas autoridades e pela sociedade.

Regulação das profissões de saúde em Ontário: autorregulação com accountability pública baseada em estatutos legais / Regulation of health professions in Ontario: self-regulation with statutory- based public accountability

Este artigo explora o modelo de regulação das profissões de saúde em Ontário, Canadá, um modelo de autorregulação construído em torno de um regime estatutário específico. O foco central do trabalho é a discussão sobre a Lei de Regulação das Profissões de Saúde de Ontário e os principais componentes de 26 leis que foram promulgadas sob sua égide para regular profissões de saúde específicas. O artigo explora a função dos colegiados regulatórios, o papel do Ministério da Saúde na determinação de escopos de prática e de outros elementos da atividade médica, e os procedimentos disciplinares e de recurso. Outras questões específicas também são brevemente abordadas, como a adequação profissional de médicos treinados no exterior e a atribuição do governo de garantir o acesso a especialistas em toda a província. A seção final analisa os desafios e as limitações do modelo, levantando uma série de controvérsias relacionadas às profissões de saúde que revelam lacunas na autorregulação, incluindo: incapacidade de estabelecer e aplicar padrões educacionais e práticos adequados em áreas específicas; falha na condução de investigações em tempo hábil sobre possíveis desvios de conduta por parte dos profissionais; e falha em questionar profissionais em posições de poder. O artigo também discute brevemente as implicações de reconhecer, por meio de regulação legal, algumas profissões alternativas e complementares de saúde; e o desafio de regular os profissionais de saúde indígenas. Conclui-se que as principais limitações do modelo regulatório surgem em razão de interesses profissionais individualistas e de relações de poder que afetam questões processuais, bem como da complexidade do próprio modelo, que pode potencialmente prejudicar o controle de qualidade.

The institutional workers of biomedical science: Legitimizing academic entrepreneurship and obscuring conflicts of interest.

Given growing initiatives incentivizing academic researchers to engage in 'entrepreneurial' activities, this article examines how these academic entrepreneurs claim value in their entrepreneurial engagements, and navigate concerns related to conflicts of interest. Using data from qualitative interviews with twenty-four academic entrepreneurs in Canada, we show how these scientists value entrepreneurial activities for providing financial and intellectual resources to academic science, as well as for their potential to create impact through translation. Simultaneously, these scientists claimed to maintain academic norms of disinterested science and avoid conflicts of interest. Using theories of institutional work, we demonstrate how entrepreneurial scientists engage in processes of institutional change-through-maintenance, drawing on the maintenance of academic norms as institutional resources to legitimize entrepreneurial activities. As entrepreneurial scientists work to legitimize new zones of academic scientific practice, there is a need to carefully regulate and scrutinize these activities so that their potential harms do not become obscured.

Transparency of Biobank Access in Canada: An Assessment of Industry Access and the Availability of Information on Access Policies and Resulting Research.

A key issue impacting public trust in biobanks is how these resources are utilized, including who is given access to biobank data and samples. To assess the conditions under which researchers are given access to Canadian biobanks, we reviewed websites and contacted Canadian biobanks to determine the availability of information on access policies and procedures; research resulting from access biobank data and samples; and conditions on private industry access to biobanks. We also conducted expert interviews with key Canadian stakeholders ( n = 11) to obtain their perspectives on biobank transparency and access policies. Among 21 Canadian biobanks, there was wide variation in the access information made publicly available, and the majority of these allowed access by industry applicants. Biobanks should be governed by the principles of transparency, accountability, and accessibility, and attention must be given to the conditions around the commercialization of biobank-based research.

Why the Shift? Taking a Closer Look at the Growing Interest in Niche Markets and Personalized Medicine.

Pharmaceutical research and development is increasingly focused on niche markets, most notably treatments for rare diseases and "personalized" medicine. Drawing on the results of a qualitative study of 34 key Canadian stakeholders (including drug regulators, funders, scientists, policy experts, pharmaceutical industry representatives, and patient advocates), we explore the major trends that are reportedly contributing to the growing interest of the pharmaceutical industry in niche markets. Informed by both these key informant interviews and a review of the relevant literature, our paper provides a critical analysis of the many different-and sometimes conflicting-views on the reasons for and extent of the shift toward niche markets. We consider some of the potential advantages to industry, as well the important implications and risks that arise from the increasing pursuit of niche markets and pharmacogenomics. While there are many potential benefits associated with targeted therapies and drug development for historically neglected rare diseases, niche market therapies also present evidentiary challenges (e.g., smaller clinical trials and enrichment strategies) that can make approval decisions difficult, and uncertainties remain around the true benefits of many therapies.