Journal of Law and the Biosciences最新文献

{"title":"Payer reimbursement practices and incentives for improving interpretation of germline genetic testing.","authors":"Patricia Deverka,&nbsp;Janis Geary,&nbsp;Charles Mathews,&nbsp;Matan Cohen,&nbsp;Gillian Hooker,&nbsp;Mary Majumder,&nbsp;Zuzana Skvarkova,&nbsp;Robert Cook-Deegan","doi":"10.1093/jlb/lsad020","DOIUrl":"https://doi.org/10.1093/jlb/lsad020","url":null,"abstract":"<p><p>Germline genetic testing for inherited cancer risk has shifted to multi-gene panel tests (MGPTs). While MGPTs detect more pathogenic variants, they also detect more variants of uncertain significance (VUSs) that increase the possibility of harms such as unnecessary surgery. Data sharing by laboratories is critical to addressing the VUS problem. However, barriers to sharing and an absence of incentives have limited laboratory contributions to the ClinVar database. Payers can play a crucial role in the expansion of knowledge and effectiveness of genetic testing. Current policies affecting MGPT reimbursement are complex and create perverse incentives. Trends in utilization and coverage for private payers and Medicare illustrate opportunities and challenges for data sharing to close knowledge gaps and improve clinical utility. Policy options include making data sharing (i) a condition of payment, and (ii) a metric of laboratory quality in payment contracts, yielding preferred coverage or enhanced reimbursement. Mandating data sharing sufficient to verify interpretations and resolve discordance among labs under Medicare and federal health programs is an option for the US Congress. Such policies can reduce the current waste of valuable data needed for precision oncology and improved patient outcomes, enabling a learning health system.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"10 2","pages":"lsad020"},"PeriodicalIF":3.4,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10332933/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9805319","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Policy options to facilitate cancer genomic variant data sharing: outcomes of a modified policy Delphi.","authors":"Jill O Robinson,&nbsp;Amira Daoud,&nbsp;Janis Geary,&nbsp;Vasiliki Rahimzadeh,&nbsp;Juli Bollinger,&nbsp;Christi J Guerrini,&nbsp;Robert Cook-Deegan,&nbsp;Amy L McGuire,&nbsp;Mary A Majumder","doi":"10.1093/jlb/lsad022","DOIUrl":"https://doi.org/10.1093/jlb/lsad022","url":null,"abstract":"<p><p>Sharing cancer gene variant and relevant clinical data could accelerate progress in cancer genomics. However, data sharing is currently impeded by issues related to financial sustainability, equity, incentives, privacy and security, and data quality. Evidence-based policy options to facilitate data sharing in these domains, and ultimately improve interpretation of cancer-associated genomic variants, are therefore needed. We conducted a modified policy Delphi with expert stakeholders that involved generating, evaluating, and ranking potential policy options to address these issues, with a focus on the US context. We found policy options in the financial sustainability domain were highly ranked, particularly stable funding for trusted entities. However, some Delphi panelists noted that the culture of public research funding has favored short-term grants. Panelists favored policy options focused on action by funders, which had the highest overall total scores that combined effectiveness and feasibility ratings and priority ranking within domains. Panelists also endorsed some policy options connected to actors such as journals, but they were more skeptical of policy options connected to legislative actors and data resources. These findings are critical inputs for policy makers as they consider policies to enable sharing of cancer gene variant data to improve health.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"10 2","pages":"lsad022"},"PeriodicalIF":3.4,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10347303/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9822624","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Doctors' duty to provide abortion information.","authors":"Michelle Oberman,&nbsp;Lisa Soleymani Lehmann","doi":"10.1093/jlb/lsad024","DOIUrl":"https://doi.org/10.1093/jlb/lsad024","url":null,"abstract":"<p><p>With abortion remaining legal in over half of the country and a proliferation of websites offering information on how to access abortion medications, for those who know where to look, there are sound options for safely ending an unwanted early-stage pregnancy. But not all patients have equal access to reliable information. This Article addresses the urgent downstream harms caused by the lack of access to abortion information, and argues that in view of these consequences, regardless of abortion's legal status, clinicians have a duty to provide their patients with abortion information. We begin by documenting clinicians' hesitation to share abortion information, drawing on our interviews with 25 doctors practicing medicine in a state where abortion is criminalized. Next, we explain why clinicians are duty-bound to provide all-options counseling. We then consider whether such duties shift where abortion is criminalized. After identifying the limited legal risks associated with supplying abortion information, and showing how, by requiring all-options counseling, professional societies might reduce risks to patients and clinicians, we conclude that, regardless of the legal status of abortion, clinicians have a professional responsibility to share basic abortion information - including treatment options and how to access those options.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"10 2","pages":"lsad024"},"PeriodicalIF":3.4,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10474560/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10149457","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Leading with the trailing edge: facilitating patient choice for insulin products.","authors":"Robin Feldman","doi":"10.1093/jlb/lsad033","DOIUrl":"https://doi.org/10.1093/jlb/lsad033","url":null,"abstract":"Abstract Insulin prices have risen sharply, despite a century since its introduction. Against this backdrop, companies have discontinued dozens of insulin products. Discontinuation could relate to safety or effectiveness, or to the overwhelming benefits of newer products. On the other hand, discontinuation could suggest strategic behavior hampering competition and supporting prices. To test these theories, this project examined every insulin discontinuation, analyzing the role discontinuations play in insulin affordability. No evidence emerged of any discontinuation for safety or effectiveness. Rather, dozens of viable products were removed from the market, followed by more expensive versions, often with little or no clinical improvement. Insulin pens with a phone app may provide advantages, for example. However, for older patients, who may find the technology confusing, or for patients with budget constraints, the value proposition falters. Moreover, discontinuation blocks biosimilars from market entry because they cannot demonstrate biosimilarity without the drug. The problem exists for all biosimilars. If there are willing buyers and willing sellers of clinically effective products that are off-patent, entry should be facilitated. This article suggests a requirement that companies deposit samples at the time of FDA approval, laying the groundwork for later entry of trailing-edge products with clinically viable outcomes.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"10 2","pages":""},"PeriodicalIF":3.4,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10718803/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138813229","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"How penalizing substance use in pregnancy affects treatment and research: a qualitative examination of researchers' perspectives.","authors":"Seema K Shah,&nbsp;Leishla Perez-Cardona,&nbsp;Khrystyna Helner,&nbsp;Suena H Massey,&nbsp;Ashish Premkumar,&nbsp;Renee Edwards,&nbsp;Elizabeth S Norton,&nbsp;Cynthia E Rogers,&nbsp;Emily S Miller,&nbsp;Christopher D Smyser,&nbsp;Matthew M Davis,&nbsp;Lauren S Wakschlag","doi":"10.1093/jlb/lsad019","DOIUrl":"https://doi.org/10.1093/jlb/lsad019","url":null,"abstract":"<p><strong>Introduction: </strong>Laws regulating substance use in pregnancy are changing and may have unintended consequences on scientific efforts to address the opioid epidemic. Yet, how these laws affect care and research is poorly understood.</p><p><strong>Methods: </strong>We conducted semi-structured qualitative interviews using purposive and snowball sampling of researchers who have engaged pregnant people experiencing substance use. We explored views on laws governing substance use in pregnancy and legal reform possibilities. Interviews were double coded. Data were examined using thematic analysis.</p><p><strong>Results: </strong>We interviewed 22 researchers (response rate: 71 per cent) and identified four themes: (i) harms of punitive laws, (ii) negative legal impacts on research, (iii) proposals for legal reform, and (iv) activism over time.</p><p><strong>Discussion: </strong>Researchers view laws penalizing substance use during pregnancy as failing to treat addiction as a disease and harming pregnant people and families. Respondents routinely made scientific compromises to protect participants. While some have successfully advocated for legal reform, ongoing advocacy is needed.</p><p><strong>Conclusion: </strong>Adverse impacts from criminalizing substance use during pregnancy extend to research on this common and stigmatized problem. Rather than penalizing substance use in pregnancy, laws should approach addiction as a medical issue and support scientific efforts to improve outcomes for affected families.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"10 2","pages":"lsad019"},"PeriodicalIF":3.4,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/d3/ed/lsad019.PMC10332932.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9972570","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Terms and conditions apply: an ethical analysis of mobile health user agreements in research.","authors":"Luke Gelinas,&nbsp;Walker Morrell,&nbsp;Barbara E Bierer","doi":"10.1093/jlb/lsad021","DOIUrl":"https://doi.org/10.1093/jlb/lsad021","url":null,"abstract":"<p><p>Mobile health (mHealth) technologies raise unique risks to user privacy and confidentiality that are often embedded in lengthy and complex Privacy Policies, Terms of Use, and End User License Agreements. We seek to improve the ethical review of these documents ('user agreements') and their risks in research using mHealth technologies by providing a framework for identifying when these risks are research risks, categorizing the key information in these agreements under relevant ethical and regulatory categories, and proposing strategies to mitigate them. MHealth user agreements typically describe the <i>nature of the data</i> collected by mHealth technologies, <i>why or for what purposes</i> user data are collected and shared, <i>who will have access</i> to the different types of data collected, and may include <i>exculpatory language.</i> The risks raised by data collection and sharing typically increase with the sensitivity and identifiability of the data and vary by whether data are shared with researchers, the technology developer, and/or third-party entities. The most important risk mitigation strategy is disclosure of the key information found in user agreements to participants during the research consent process. In addition, researchers should prioritize mHealth technologies with favorable risk-benefit balances.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"10 2","pages":"lsad021"},"PeriodicalIF":3.4,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/e5/20/lsad021.PMC10347671.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9825935","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Is benefit sharing with research participants lawful in South Africa? An unexplored question in the governance of genomics research.","authors":"Donrich Thaldar, Bonginkosi Shozi","doi":"10.1093/jlb/lsad018","DOIUrl":"10.1093/jlb/lsad018","url":null,"abstract":"<p><p>Despite advocacy in favour of benefit sharing with research participants in genomics research that is conducted in South Africa, there has been little critical legal engagement with this concept. That is what this article provides by posing the hitherto unexplored-but foundational-question: Is benefit sharing with research participants lawful in South Africa? The answer is clearly 'no'. South African law provides that it is unlawful to provide any financial or other reward to research participants for donating biospecimens-except for reimbursement of reasonable costs incurred. Accordingly, benefit sharing would be unlawful. The ramifications of this conclusion are far-reaching. Most pertinently, should any benefit-sharing agreements with research be put into practice, such agreements would be unenforceable and would expose all parties involved-including foreign collaborators-to criminal prosecution. The solution for proponents of benefit sharing in South Africa would be to lobby the South African government to revise the relevant law. However, as long as the law remains as it currently is, institutions and individuals all over the world who are involved in genomics research in South Africa would be well advised to comply with the law by not engaging in benefit sharing with research participants.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"10 1","pages":"lsad018"},"PeriodicalIF":2.5,"publicationDate":"2023-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10307998/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9736472","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Governing nonconventional genetic experimentation.","authors":"Maxwell J Mehlman, Ronald A Conlon, Alex Pearlman","doi":"10.1093/jlb/lsad003","DOIUrl":"10.1093/jlb/lsad003","url":null,"abstract":"<p><p>A large and highly heterogeneous group of individuals conducts genetic and genomic research outside of traditional corporate and academic settings. They can be an important source of innovation, but their activities largely take place beyond the purview of existing regulatory systems for promoting safe and ethical practices. Historically the gene-targeting technology available for non-traditional genomic research has been limited, and therefore these activities have attracted little regulatory attention. New technologies such as CRISPR/Cas9, however, give nonconventional experimenters more extensive gene editing abilities at an unprecedented level of accessibility. The affordability and accessibility of these powerful technologies are raising questions about whether the current largely laissez-faire governance approach is adequate. This article recommends steps to enhance self-governance, including establishing umbrella organizations to represent community interests, creating a community IRB modelled on the DIYBio Ask a Safety Expert Service, and adopting an ethical obligation to report rogue experiments.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"10 1","pages":"lsad003"},"PeriodicalIF":3.4,"publicationDate":"2023-03-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9997442/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9086809","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Lessons from Canada's notice of compliance with conditions policy for the life-cycle regulation of drugs.","authors":"Melanie McPhail,&nbsp;Howard Zhang,&nbsp;Zohra Bhimani,&nbsp;Tania Bubela","doi":"10.1093/jlb/lsad008","DOIUrl":"https://doi.org/10.1093/jlb/lsad008","url":null,"abstract":"<p><p>Innovative health technologies are not well regulated under current pathways, leading regulators to adopt contextual, life-cycle regulatory models, which authorize drugs based on earlier clinical evidence subject to the conduct of post-market trials that confirm clinical benefit and safety. In this paper, we evaluate all drugs authorized in Canada under the Notice of Compliance with conditions (NOC/c) policy from 1998 to 2021 to analyze its function, identify challenges and areas for improvement, and make recommendations to inform Health Canada's regulatory reforms. We analyzed a sample of 148 drugs authorized between 1998 and 2021, including characteristics about the pre- and post-market clinical trials, finding that most NOC/c authorizations are based on one, single-arm clinical trial using a surrogate endpoint. Post-market trials are more likely to be randomized, Phase III trials but mostly use surrogate endpoints. Based on our findings, we recommend increasing decision-making transparency throughout the regulatory process, developing comprehensive eligibility criteria for selecting appropriate health technologies, modernizing pre-market evidence requirements, adopting a more active role in designing post-market trials, and utilizing automatic expiry, stronger penalties, and ongoing disclosure of the status of post-market trials to promote compliance.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"10 1","pages":"lsad008"},"PeriodicalIF":3.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10101551/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9303392","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"FDA preemption of conflicting state drug regulation and the looming battle over abortion medications.","authors":"Peter Grossi,&nbsp;Daphne O'Connor","doi":"10.1093/jlb/lsad005","DOIUrl":"https://doi.org/10.1093/jlb/lsad005","url":null,"abstract":"&lt;p&gt;&lt;p&gt;Over the past 25 years, Congress and the FDA have determined the safest and most beneficial way to regulate the use of mifepristone (Mifeprex), the medication that accounts for the majority of abortions in the United States. The &lt;i&gt;Dobbs&lt;/i&gt; decision has renewed the importance of those scientific determinations, especially FDA's decisions implementing the Risk Evaluation and Mitigation Strategy (REMS) provisions of the Federal Food Drug and Cosmetic Act (FDCA), that mifepristone may be taken by patients outside the presence of any healthcare provider (often through telemedicine prescription and shipment across state lines). Now that &lt;i&gt;Dobbs&lt;/i&gt; has been decided, state officials have indicated that they will seek to enforce state statutes which conflict with FDA's regimen for the proper use of mifepristone, by banning its use entirely, prohibiting telemedicine prescription, or imposing other requirements which FDA has specifically considered and now rejected as contrary to the congressional mandate that FDA-approved drugs be as accessible as safety considerations allow. Litigation has already been filed to invalidate such statutes on the grounds that they are preempted by the doctrine that state law which conflicts with, or undermines the purposes of, FDA actions with respect to approved drugs are preempted under the Supremacy Clause of the Constitution. This article examines the Supreme Court caselaw and FDA actions which will dictate the outcome of that litigation. Part I details the statutory basis for FDA preemption of conflicting state law and the four decisions by the Supreme Court over the last 13 years (&lt;i&gt;Levine, Mensing, Bartlett&lt;/i&gt; and &lt;i&gt;Albrecht&lt;/i&gt;) which enunciate the governing legal standards for FDA preemption. We pay particular attention to the opinions of Justice Alito and the other conservative justices, which hold that such FDA preemption should be robust to ensure that there is one consistent, national policy for the distribution and regulation of drugs, under the science-based decisions of the FDA, rather than the 'parochialism' of differing state standards. Part II details FDA's comprehensive program for the balanced, though appropriately restricted, use of mifepristone, and the 22 years of FDA actions that brought that about. It then catalogs the state statutes limiting the use of the drug which, in material ways, conflict with those FDA determinations. Part III outlines the arguments made in one early lawsuit seeking preemption of the statutes of one state (Mississippi)-a law suit which previews the wider litigation to come. It then sets forth the strong arguments for FDA preemption of each type of state restriction and responses to the 'defenses' of those statutes that have been offered in an effort to avoid FDA preemption under the Supremacy Clause. That review shows that a straight-forward application of the FDCA and the Supreme Court caselaw should result in the preemption of the state restrictions that square","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"10 1","pages":"lsad005"},"PeriodicalIF":3.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10017072/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9146320","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}