Journal of Law Medicine & Ethics最新文献

{"title":"FDA Advisory Committee Review of Supplemental Indications and Reasons for Non-Approval, 2008-2022.","authors":"Audrey D Zhang, Nikhil Chaudhry, Reshma Ramachandran, Joseph S Ross, Jason L Schwartz","doi":"10.1017/jme.2025.53","DOIUrl":"https://doi.org/10.1017/jme.2025.53","url":null,"abstract":"<p><p>This study characterizes 2008-2022 FDA advisory committee discussions of new supplemental indication applications that were not approved by FDA. Discussion themes included contextual concerns unique to already-approved drugs, including insights from prior experience and concerns about off-label use, and efficacy and safety concerns also observed for new drugs. These findings highlight advisory committees' role in transparency of regulatory decision-making, specifically for drugs already authorized for use.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"1-8"},"PeriodicalIF":1.6,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143804578","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Genome Editing in Medicine: A Scoping Review of Ethical, Bioethical, and Medico-Legal Implications.","authors":"Filippo Gibelli, Giovanna Ricci, Paolo Bailo","doi":"10.1017/jme.2025.48","DOIUrl":"https://doi.org/10.1017/jme.2025.48","url":null,"abstract":"<p><p>Genome editing, prominently led by the revolutionary CRISPR-Cas9 technology, is a powerful tool with significant applications in diverse fields, particularly in medicine and agriculture. It empowers scientists with the ability to effect precise genetic modifications, thereby potentially paving the way for advanced treatments for genetic disorders such as Huntington's disease, hemophilia, and cystic fibrosis. Yet, the significant capabilities of this technology also brings to the fore a myriad of intricate bioethical, legal, and regulatory dilemmas. In light of these complexities, this article endeavors to conduct a comprehensive scoping review of the existing literature on the most significant ethical implications emanating from genome editing. In conducting this review, we utilized the power of software tools like EndNote and Rayyan to aid in the systematic and thorough review of the literature. EndNote, a reference management software, was instrumental in organizing and managing the references and bibliographies, while Rayyan, a web application designed for managing and screening records for systematic and scoping reviews, proved crucial in the import and management of text records for the review.The review identified as main aspects of ethical, bioethical and medico-legal interest the exacerbation of social inequalities, safety concerns such as off-target mutations and immunological risks, ecological and evolutionary implications, and challenges to human dignity. It highlights the necessity for equitable access, rigorous regulation, and public engagement to address these issues responsibly.The ultimate objective of this article is to underscore the importance of an informed and inclusive dialogue regarding genome editing. Such dialogue is pivotal for fostering responsible innovation in this rapidly advancing field, ensuring that scientific progress aligns with ethical considerations. By presenting a comprehensive examination of the ethical implications of genome editing, we aim to contribute to this ongoing dialogue and promote a balanced and nuanced understanding of this impactful technology.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"1-9"},"PeriodicalIF":1.6,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143804582","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patent Thickets and Product Hops: Challenges and Opportunities for Legislative Reform.","authors":"William B Feldman","doi":"10.1017/jme.2025.54","DOIUrl":"https://doi.org/10.1017/jme.2025.54","url":null,"abstract":"<p><p>Two key strategies that brand-name pharmaceutical manufacturers employ to limit generic competition are patent thickets and product hops. The former strategy entails obtaining numerous patents on peripheral features of products (not just the active ingredients), and the latter involves shifting active ingredients into reformulations with new patent protection that can extend periods of market exclusivity. These strategies have become particularly problematic for drug-device combinations like inhalers and glucagon-like peptide-1 receptor agonists, which contain pharmaceutical compounds that are sold together with their delivery devices. The Senate Judiciary Committee moved three bipartisan bills out of committee during the last legislative session aimed at facilitating more timely generic competition. Although these bills offer a valuable step forward, more is needed to limit the sort of patent gamesmanship that has become pervasive in the US pharmaceutical industry. Such reforms should include routine reexamination by the US Patent and Trademark Office of patents submitted for listing with the Food and Drug Administration (FDA), a greater role for the FDA in reviewing such listings, limits on the number of patents that brand-name firms can assert when suing for infringement following patent challenges, stronger incentives for patent challenges, and more flexibility for the FDA to approve complex generic drugs.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"1-6"},"PeriodicalIF":1.6,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143804584","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comment on \"Vaccine Procurement: The Changes Needed to Close Access Gaps and Achieve Health Equity in Routine and Pandemic Settings\".","authors":"Hinpetch Daungsupawong, Viroj Wiwanitkit","doi":"10.1017/jme.2025.49","DOIUrl":"https://doi.org/10.1017/jme.2025.49","url":null,"abstract":"","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"1"},"PeriodicalIF":1.6,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143804576","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Research Misconduct and Medical Journals.","authors":"Howard Bauchner, Robert Steinbrook, Rita F Redberg","doi":"10.1017/jme.2025.35","DOIUrl":"https://doi.org/10.1017/jme.2025.35","url":null,"abstract":"<p><p>Journal editors often deal with allegations of research misconduct, defined by the Office of Research Integrity (ORI) in the United States as fabrication, falsification, and plagiarism. It is important that editors have a transparent and consistent process to deal with these allegations quickly and fairly. This process will include the authors and may include research integrity officers at the sponsoring institution as well as funders. Retractions may not be consistent with the ORI definition, for example, specifying inadequate peer-review and unreported conflict of interest, but nevertheless represent scientific misconduct.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"1-6"},"PeriodicalIF":1.6,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143722415","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reflections on Progress and Shaping the Future of Maternal and Child Health in Global Health Law.","authors":"Flavia Bustreo","doi":"10.1017/jme.2025.11","DOIUrl":"https://doi.org/10.1017/jme.2025.11","url":null,"abstract":"<p><p>When Larry Gostin published the groundbreaking 2014 treatise on Global Health Law, building on the work of others like Virginia Leary, the field of global health law was still being developed. This treatise offered a comprehensive definition and understanding of global health law. Others, including myself, used Larry's work to formulate policy recommendations and strengthen references to the right to health in global health.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"1-2"},"PeriodicalIF":1.6,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143722413","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reflections on the SDGs and UHC: Getting Shit Done.","authors":"Peter A Singer","doi":"10.1017/jme.2025.7","DOIUrl":"https://doi.org/10.1017/jme.2025.7","url":null,"abstract":"<p><p>I write in tribute to my friend Larry Gostin, who has long emphasized that accountability and governance are central to global health policy.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"1"},"PeriodicalIF":1.6,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143722414","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Global Health \"With Justice\": The Challenges and Opportunities for Human Rights in Global Health Law.","authors":"Lisa Forman, Safura Abdool Karim, Omowamiwa Kolawole","doi":"10.1017/jme.2025.1","DOIUrl":"https://doi.org/10.1017/jme.2025.1","url":null,"abstract":"<p><p>Human rights offer to ground global health law in equity and justice. Human rights norms, advocacy, and strategies have proven successes in challenging private and public inequities and in realizing more equitable domestic and global health governance. However, mobilizing human rights within global health law faces enormous political, economic, technological, and epidemiological challenges, including from the corrosive health impacts of power, politics, and commerce. This article focuses on what human rights could bring to three major global health law challenges - health systems strengthening and universal health coverage, the commercial and economic determinants of health, and pandemic disease threats. We argue that human rights offer potentially powerful norms and strategies for achieving equity and justice in these and other key global health domains. The challenge for those working in human rights and global health law is to work nimbly, creatively, and courageously to strengthen the contribution of these instruments to health justice.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"1-5"},"PeriodicalIF":1.6,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143722235","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Misconduct Detection - Evolving Methods & Lessons from 15 Years of Scientific Image Sleuthing.","authors":"Paul S Brookes","doi":"10.1017/jme.2025.32","DOIUrl":"https://doi.org/10.1017/jme.2025.32","url":null,"abstract":"<p><p>I have been investigating and reporting on image manipulation in the bioscience literature since 2011. During this time, several new tools have emerged to streamline the processes of image analysis and reporting. When presenting and discussing examples of scientific image manipulation, a common question is \"how do you find this stuff?\" Herein, I outline common software and other utilities - a toolbox for discovery and reporting of problematic scientific images and other data. This may serve as a useful reference for those seeking to enhance the effective removal of problematic papers from the bioscience literature.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"1-11"},"PeriodicalIF":1.6,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143722298","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Legal Underpinnings of the Great Vaccine Debate of 2025.","authors":"James G Hodge","doi":"10.1017/jme.2025.51","DOIUrl":"https://doi.org/10.1017/jme.2025.51","url":null,"abstract":"<p><p>Multiple factors aligning in 2025 implicate challenges to vaccines as a primary public health intervention. Anti-vaccine proponents seek to recast immunization policies in promotion of perceived individual liberties. Recalibrating national vaccine approaches, however, runs counter to long-standing public health laws and policies grounded in a core truth: safe and effective vaccines save lives.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"1-5"},"PeriodicalIF":1.6,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143722293","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}