Journal of Law Medicine & Ethics最新文献

I will describe how a fraudulent paper developed and offer insights into the institutional changes that are needed. I was a co-author on a paper described as a "clusterfake" due to at least two frauds allegedly occurring in the same paper. I will use my knowledge of behavioral ethics and my experience as a co-author on a fraudulent paper to explore changes that are needed to improve research integrity.

The federal government has a long history of trying to find the right balance in supporting scientific and medical research while protecting the public and other researchers from potential harms. To date, this balance has been generally calibrated differently across contexts - including in clinical care, human subjects research, and research integrity. New challenges continue to face this disparate model of regulation, including novel Generative Artificial Intelligence (GenAI) tools. Because of potential increases in unintentional fabrication, falsification, and plagiarism using GenAI - and challenges establishing both these errors and intentionality in retrospect - this article argues that we should instead move toward a system that sets accepted community standards for the use of GenAI in research as prospective requirements.

Trust in the validity of published work is of fundamental importance to scientists. Confirmation of validity is more readily attained than addressing the question of whether fraud was involved. Suggestions are made for key stakeholders - institutions and companies, journals, and funders as to how they might enhance trust in science, both by accelerating the assessment of data validity and by segregating that effort from investigation of allegations of fraud.

Global health security in the Biden-Harris Administration has been a dynamic area of engagement, starting with the COVID-19 response, to strengthening and reforming the World Health Organization, to bolstering regional partnerships, and securing financing for pandemic preparedness. Sustained commitment to bilateral, regional, and multilateral cooperation will ensure that the United States stands ready to address any future health challenges.

This article first describes shifts in human rights law that have led to improvements in the realization of sexual and reproductive health and rights (SRHR) over the last decade. The article does so, however, with careful attention to the structural factors beyond formal legal mechanisms that may undermine the ability of governments, even with the best of intentions, to fully develop the necessary robust health and justice systems. Second, this article considers two additional factors: the political economy factors that enable or limit the ability of States to realize SRHR, as well as the growing evidence base that supports positive legal transformation.

Brand-name pharmaceutical firms increasingly use method of use patents and associated Orange Book "use codes" to delay generic entry, complicating the skinny labeling pathway that permits low-cost generics to omit patented indications from their labels and market their products for unpatented uses. Recent litigation, however, shows how overlapping use codes - targeting patient subgroups or biomarker thresholds rather than distinct conditions - can obstruct the skinny labeling pathway. Case studies of icosapent ethyl (Vascepa) and sacubitril-valsartan (Entresto) illustrate how overlapping use codes delay generic entry, inflate costs, and limit patient access. Reforms are needed to improve FDA and USPTO oversight of use code assignments and clarify legal standards for induced infringement, which would preserve the balance between rewarding innovation and ensuring timely access to affordable medicines.

Artificial Intelligence (AI) is transforming public health, presenting both opportunities and ethical and legal challenges. This study adopts an interdisciplinary approach, integrating legal doctrinal analysis, public health ethics, AI governance scholarship and a scoping review of international legal instruments to evaluate and operationalize three core pillars: ethical accountability, regulatory adaptability and transparency. Through a scoping review of treaties, regional regulations and policy frameworks, the study maps jurisdictional gaps and proposes an adaptive public law framework that addresses critical shortcomings in existing AI governance models, such as the WHO's limited enforceability and the GDPR's rigid data-sharing rules. The framework introduces scalable, region-specific regulations to enhance interoperability while respecting local governance needs. Its human-centric design, modular regulation and accountability mechanisms ensure adaptability across diverse legal, cultural and health system contexts. Informed by case studies and a thematic synthesis of global best practices, this framework offers policymakers and practitioners a structured yet flexible approach to balancing AI-driven innovation with ethical imperatives, promoting equitable public health outcomes.

Voluntary firearm safety actions avoid Second Amendment scrutiny, but rely on individuals recognizing their own risks. This could be aided by a network of healthcare professionals that have received proper training and information about all available tools to help prevent firearm-related suicide attempts, and combining the trust of clinicians and firearm owners could represent an opportunity to inform and educate in a manner that will engage patients.

On October 21, 2022, the Spanish Competition Agency (CNMC) sanctioned the North American pharmaceutical company Merck Sharp & Dohme for abuse of a dominant position. The practice for which it was finally sanctioned consisted of the adoption of a strategy aimed at delaying and making it difficult for another company to enter the Spanish medicines market in order to protect sales for a product marketed exclusively by that company and for which had a patent. This paper analyzes this resolution in an attempt to delimit the difference between the legitimate exercise of the right to effective judicial protection and its abuse.

Law can function and act on norms, through legislation, regulation, treaties and the like. Law can also be a key accompaniment to activism. The career of Larry Gostin represents both aspects of the law in achieving social change.