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1.
Palliat Support Care ; 21(5): 871-878, 2023 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-37462416

RESUMO

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.


Assuntos
Médicos , Suicídio Assistido , Humanos , Canadá , Assistência Médica
2.
J Med Ethics ; 2022 Dec 05.
Artigo em Inglês | MEDLINE | ID: mdl-36600579

RESUMO

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.

8.
Med Law Rev ; 22(2): 200-20, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-24841527

RESUMO

In response to rising demands and treatment costs, and the need to achieve better value for money in the face of tight fiscal constraints, both the National Health Service and the public drug reimbursement system are undergoing important reforms. Concurrently, the pharmaceutical sector itself is also alleged to be experiencing significant changes, perhaps most notably, a decline of the blockbuster model of drug development and a growing focus on niche market products. As pharmaceutical development strategies evolve and the resulting drug products become more complex, regulatory and policy responses must be able to evolve along with them. We explore how in numerous jurisdictions, including the UK, proposals for 'adaptive licensing' on the regulatory side and 'performance-based risk sharing agreements' on the funding side are shifting the focus of drug regulation and reimbursement towards more incremental access to new therapies and more post-market evidence generation. However, serious questions remain about how such reforms can be successfully implemented and whether they can balance demands for earlier access to promising new therapies with the need for robust evidence on safety, efficacy, and cost-effectiveness.


Assuntos
Regulamentação Governamental , Reforma dos Serviços de Saúde/legislação & jurisprudência , Legislação de Medicamentos , Medicamentos sob Prescrição/economia , Publicidade , Aprovação de Drogas/legislação & jurisprudência , Descoberta de Drogas , Indústria Farmacêutica , Europa (Continente) , Reforma dos Serviços de Saúde/economia , Humanos , Produção de Droga sem Interesse Comercial , Farmacogenética , Mecanismo de Reembolso/legislação & jurisprudência
10.
Indian J Med Ethics ; VII(3): 179-183, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36043260

RESUMO

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


Assuntos
Autoria , Editoração , Humanos , Organizações
11.
BMJ Glob Health ; 7(5)2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-35618306

RESUMO

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.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Política de Saúde , Vacinação , COVID-19/prevenção & controle , Humanos , Vacinação/legislação & jurisprudência
14.
Rev Panam Salud Publica ; 30(1): 87-96, 2011 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-22159656

RESUMO

The objective of this article is to propose a roadmap toward transparency of clinical trials in the Americas by their prospective registration and results disclosure. This will broaden access to more complete and accurate data and facilitate evidence-informed decision-making and participation in research. Consequently, it should have a positive impact on people's health and should promote trust in health research. Existing initiatives were identified, registration of trials was analyzed following the World Health Organization (WHO) standards on trial registration, and a roadmap is proposed to address the gaps in advancing transparency. The analysis shows that, in spite of numerous regional and country initiatives, clinical trials taking place in nonEnglish-speaking parts of the Americas are underregistered. A roadmap is proposed to enhance research governance and good research practice by improving the transparency of clinical trials. The proposed roadmap includes strategies for implementing WHO international standards for trial registration, for developing international standards of public disclosure of trial results, and for a potential role of the Pan American Health Organization.


Assuntos
Ensaios Clínicos como Assunto/métodos , Revelação , Sistemas de Notificação de Reações Adversas a Medicamentos , América , Ensaios Clínicos como Assunto/ética , Ensaios Clínicos como Assunto/normas , Coleta de Dados , Revelação/ética , Revelação/normas , Registros Eletrônicos de Saúde , Humanos , Disseminação de Informação/ética , Consentimento Livre e Esclarecido , Cooperação Internacional , Estudos Multicêntricos como Assunto/ética , Estudos Multicêntricos como Assunto/métodos , Estudos Multicêntricos como Assunto/normas , Seleção de Pacientes , Projetos de Pesquisa/normas , Resultado do Tratamento , Revelação da Verdade , Organização Mundial da Saúde
15.
Int J Health Serv ; 51(1): 5-13, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-33349145

RESUMO

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.


Assuntos
Ensaios Clínicos como Assunto , Aprovação de Drogas , Controle de Medicamentos e Entorpecentes/legislação & jurisprudência , COVID-19 , Canadá , Qualidade de Produtos para o Consumidor , Europa (Continente) , Humanos , SARS-CoV-2 , Estados Unidos
17.
Sci Public Policy ; 45(3): 404-415, 2018 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-29937617

RESUMO

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.

19.
J Empir Res Hum Res Ethics ; 12(5): 310-325, 2017 12.
Artigo em Inglês | MEDLINE | ID: mdl-28818009

RESUMO

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.


Assuntos
Acesso à Informação , Bancos de Espécimes Biológicos/ética , Pesquisa Biomédica/ética , Comércio , Indústrias , Políticas , Responsabilidade Social , Canadá , Humanos , Pesquisadores , Confiança
20.
PLoS Med ; 3(7): e309, 2006 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-16848618

RESUMO

BACKGROUND TO THE DEBATE: An important mechanism for protecting human research participants is the prior approval of a clinical study by a research ethics board, known in the United States as an institutional review board (IRB). Traditionally, IRBs have been run by volunteer committees of scientists and clinicians working in the academic medical centers where the studies they review are being carried out. However, for-profit organizations are increasingly being hired to conduct ethics reviews. Proponents of for-profit IRBs argue that these IRBs are just as capable as academic IRBs at providing high-quality ethics reviews. Critics argue that for-profit IRBs have a conflict of interest because they generate their income from clients who have a direct financial interest in obtaining approval.


Assuntos
Pesquisa Biomédica/ética , Comitês de Ética em Pesquisa/economia , Experimentação Humana/ética , Revisão Ética , Comitês de Ética em Pesquisa/organização & administração , Ética em Pesquisa , Humanos
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