The American journal of bioethics : AJOB最新文献

{"title":"When to Disclose a Borderline Incidental Finding.","authors":"Susanna McGrew, Benjamin E Berkman","doi":"10.1080/15265161.2022.2110975","DOIUrl":"https://doi.org/10.1080/15265161.2022.2110975","url":null,"abstract":"Bourke, E., P. Snow, A. Herlihy, D. Amor, and S. Metcalfe. 2014. A qualitative exploration of mothers’ and fathers’ experiences of having a child with Klinefelter syndrome and the process of reaching this diagnosis. European Journal of Human Genetics 22 (1):18–24. doi:10.1038/ejhg.2013.102. Close, S., L. Sadler, and M. Grey. 2016. In the dark: Challenges of caring for sons with Klinefelter syndrome. Journal of Pediatric Nursing 31 (1):11–20. doi:10.1016/j. pedn.2015.05.002. Giagulli, V. A., B. Campone, M. Castellana, C. Salzano, A. D. Fisher, C. de Angelis, R. Pivonello, A. Colao, D. Pasquali, M. Maggi, et al. 2019. Neuropsychiatric aspects in men with Klinefelter syndrome. Endocrine, Metabolic & Immune Disorders Drug Targets 19 (2):109–15. doi:10. 2174/1871530318666180703160250. Johnson, L.-M., D. M. Duenas, and B. S. Wilfond. 2022. To disclose or not to disclose: Secondary findings of XXY chromosomes. The American Journal of Bioethics 22 (10): 87–88. Miller, D. T., K. Lee, A. S. Gordon, L. M. Amendola, K. Adelman, S. J. Bale, W. K. Chung, M. H. Gollob, S. M. Harrison, G. E. Herman, R. E. Hershberger, T. E. Klein, K. McKelvey, C. S. Richards, C. N. Vlangos, D. R. Stewart, M. S. Watson, and C. L. Martin. 2021. Recommendations for reporting of secondary findings in clinical exome and genome sequencing, 2021 update: A policy statement of the American College of Medical Genetics and Genomics (ACMG). Genetics in Medicine 23 (8):1391–8. doi:10.1038/s41436-021-01171-4. Miner, S. A., D. Daumler, P. Chan, A. Gupta, K. Lo, and P. Zelkowitz. 2019. Masculinity, mental health, and desire for social support among male cancer and infertility patients. American Journal of Men’s Health 13 (1):1557988318820396. doi:10.1177/15579883 18820396. Turriff, A., H. P. Levy, and B. Biesecker. 2015. Factors associated with adaptation to Klinefelter syndrome: The experience of adolescents and adults. Patient Education and Counseling 98 (1):90–5. doi:10.1016/j.pec.2014.08.012. Turriff, A., E. Macnamara, H. P. Levy, and B. Biesecker. 2017. The impact of living with Klinefelter syndrome: A qualitative exploration of adolescents and adults. Journal of Genetic Counseling 26 (4):728–37. doi:10.1007/s10897016-0041-z. Visootsak, J., N. Ayari, S. Howell, J. Lazarus, and N. Tartaglia. 2013. Timing of diagnosis of 47,XXY and 48,XXYY: A survey of parent experiences. American Journal of Medical Genetics Part A 161 (2):268–72. doi: 10.1002/ajmg.a.35709.","PeriodicalId":145777,"journal":{"name":"The American journal of bioethics : AJOB","volume":" ","pages":"91-93"},"PeriodicalIF":13.4,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40380441","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Harm Reduction Ethics, Public Health, and the Manufacture of Doubt.","authors":"Daniel S Goldberg","doi":"10.1080/15265161.2022.2110989","DOIUrl":"https://doi.org/10.1080/15265161.2022.2110989","url":null,"abstract":"Svirsky, Howard, and Berman’s (2022) paper “E-Cigarettes and the Multiple Responsibilities of the FDA” offers a significant contribution to a knowledge domain that might be called “harm reduction ethics.” This domain is in turn an important subject area within public health ethics and population-level bioethics specifically focused on the enormous burdens of noncommunicable disease. Despite the more recent energy (understandably) focused on pandemic and infectious disease ethics, tobacco consumption remains one of the leading causes of preventable disease both in the U.S. and globally. While the present paper focuses on the US, it is also important to remember that FDA regulation has global impact, which matters inasmuch as 80% of the world’s 1.3 billion tobacco users live in lowand middle-income countries (“LMICs”) (World Health Organization 2022). Svirsky, Howard, and Berman offer a sophisticated analysis that sidesteps the wrangling over the precise state of the evidence in favor of a birds-eye view that addresses how evidence is weighed and acted upon within the larger regulatory state. Such a bird’s eye view is characteristic of population-level bioethics (Wikler and Brock 2007) and offers significant advantages in conceptualizing the role or lack thereof of ecigarettes in reducing the harm of combustible tobacco use. For example, Svirsky, Howard, and Berman highlight that the extent to which e-cigarettes reduce the harm associated with tobacco consumption is absolutely not an inherent feature of the product itself. Rather, they argue, “[w]hether e-cigarettes are a net benefit or detriment inherently depends upon the regulatory scheme in which these products are marketed and promoted. This regulatory framework is, in turn, overseen by the FDA” (16). They also note that FDA and agency regulation of combustible tobacco has a great effect on the extent to which e-cigarettes do or do not reduce the harms associated with tobacco consumption. This analysis not only underscores that analysis of benefits and harms cannot be performed solely by an internalist focus on biomarkers and randomized, controlled trials, but also emphasizes public health agencies’ general capacity to determine health outcomes and their distribution within the populations they serve. One of the foundations of the field of public health law is that law is a major social determinant of health (Burris et al. 2018). In emphasizing different roles that the FDA plays, Svirsky, Howard, and Berman are deepening collective understanding of the various tools and pathways through which public health regulatory bodies literally determine overall health outcomes and health inequalities. The FDA does not impact health merely through approval of drugs and devices, but also, as Svirsky, Howard, and Berman explain, via its roles as knowledge purveyor, knowledge producer, adviser, and as market agent. Nor do the authors claim that these four roles are exhaustive; there are likely other roles a","PeriodicalId":145777,"journal":{"name":"The American journal of bioethics : AJOB","volume":" ","pages":"18-20"},"PeriodicalIF":13.4,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40380425","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"We Don't Offer What Can't Be Chosen: Why Harmful Consequences Should Not Be \"Decisive\" in Assessing Decision-Making.","authors":"David J Satin, Marc Tunzi, Philip Day","doi":"10.1080/15265161.2022.2110980","DOIUrl":"https://doi.org/10.1080/15265161.2022.2110980","url":null,"abstract":"Appelbaum, P. S., and T. Grisso. 1988. Assessing patients’ capabilities to consent to treatment. The New England Journal of Medicine 319 (25):1635–8. doi:10.1056/ NEJM198812223192504. Kohn, N. A., J. Blumenthal, and A. Campbell. 2013. Supported decision-making: A viable alternative to guardianship? Penn State Law Review 117 (4):1111–57. Peterson, A., J. Karlawish, and E. Largent. 2021. Supported decision making with people at the margins of autonomy. The American Journal of Bioethics 21 (11):4–18. doi:10. 1080/15265161.2020.1863507. Pickering, N., G. Newton-Howes, and G. Young. 2022. Harmful choices, the case of C, and decision-making competence. The American Journal of Bioethics 22 (10): 38–50. doi:10.1080/15265161.2021.1941422. Wright, M. S. 2018. End of life and autonomy: The case for relational nudges in end-of-life decision-making law and policy. Maryland Law Review 77 (4):1602–141. Wright, M. S. 2019. Dementia, healthcare decision making, and disability law. The Journal of Law, Medicine & Ethics 47 (4_suppl):25–33. doi:10.1177/1073110519898040. Wright, M. S. 2020. Dementia, autonomy, and supported healthcare decision making. Maryland Law Review 79 (2): 257–324. Wright, M. S. 2021a. Equality of autonomy? Physician aid in dying and supported decision-making. Arizona Law Review 63:157–97. Wright, M. S. 2021b. Implementing ethical and legal supported decision making: Some unresolved issues. The American Journal of Bioethics 21 (11):40–2. doi:10.1080/ 15265161.2021.1980148. Wright, M. S. 2022. Resuscitating consent. Boston College Law Review 63 (3):887–956.","PeriodicalId":145777,"journal":{"name":"The American journal of bioethics : AJOB","volume":" ","pages":"60-62"},"PeriodicalIF":13.4,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40380435","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Conceptual Compatibility and Transparency in Capacity Assessments.","authors":"Peter Maloy Koch","doi":"10.1080/15265161.2022.2110992","DOIUrl":"https://doi.org/10.1080/15265161.2022.2110992","url":null,"abstract":"In “Harmful Choices, the case of C, and decision making competence,” Pickering et al. (2022) offer a thought-provoking interpretation of the relationship between harm and capacity assessments by analyzing the case of C. The authors propose what they call the Explanatory/Causal Account, in which “a person who is considering or has already made a decision which appears seriously harmful to that person should in some cases be judged incapable of making that decision because of the harmfulness of the decision” (38). The following commentary questions the compatibility of the Explanatory/Causal Account with notions of capacity, competence, and incompetence as defined by the authors, and then explores an important ethical implication of this potential incompatibility. The authors define capacity, competence, and incompetence as follows (emphasis mine; each term, when used as defined here, will be capitalized going forward):","PeriodicalId":145777,"journal":{"name":"The American journal of bioethics : AJOB","volume":" ","pages":"51-53"},"PeriodicalIF":13.4,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40380445","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Preserve Patient Autonomy; Resist Expanding the Harm Principle to Override Decisions by Competent Patients.","authors":"Edward McArdle","doi":"10.1080/15265161.2022.2110988","DOIUrl":"https://doi.org/10.1080/15265161.2022.2110988","url":null,"abstract":"In this thoughtful article analyzing a UK court decision upholding a patient’s refusal of dialysis (Pickering et al. 2022), the authors make the provocative but ultimately unpersuasive argument that clinicians should be allowed to rely on the harm-to-self principle as a basis to override a competent patient’s refusal of life-sustaining medical treatment when they disagree with that decision. Although there is an emotional pull to their proposal, and it could ease moral distress for clinicians who feel ethically and professionally conflicted when they can’t use their expertise to save lives they believe are worth saving, the danger principle could easily act as a disguised form of paternalism, carries with it implicit bias, and would be a setback to modern gains made in medicine in promoting patient-centered care. Modern liberal society is built on the principle that people are entitled to individual freedom and liberty; it is based on the belief that people have inherent worth and are in the best position to know what is good for them (Will 2011). Implicit in this framework is that people with decision-making capacity have the right, with limited interference, to make their own decisions even if those decisions could harm them. Modern medicine is likewise founded on respect for and promotion of individual autonomy (Will 2020). However, this is a relatively recent development. For much of its existence, medicine has followed a “doctor knows best” paternalism based on principles of beneficence and nonmaleficence. It was only a little over a century ago that the right of competent adults to consent to medical treatment was legally recognized. Over the ensuing decades, a fundamental shift occurred in medicine to an autonomy-based model (Will 2020). Today, the principles of autonomy and respect for persons stand at the forefront of medicine (Will 2020). It is well established that competent patients can refuse life-sustaining treatment. Further, the shared-decision-making model has become the prototype for enabling informed consent and supporting patient choices. It consists of a collaborative discussion between clinicians and patients in which clinicians share their medical expertise, provide information to patients in understandable language about the risks and benefits of recommended treatments, and encourage patients to participate, ask questions, and share information about their wishes, preferences, and values, with treatment decisions made consistent with those values (Childress and Childress 2020). Pickering et al. (2022) argue for a limited physician carveout of authority from the autonomy-based model. Specifically, they propose that external factors that include the patient’s welfare and potential for harm from refusing treatment should be balanced against internal factors traditionally used to determine a patient’s decision-making ability. Patient wishes will only prevail if they meet a “higher bar” for measuring competence. Although the ar","PeriodicalId":145777,"journal":{"name":"The American journal of bioethics : AJOB","volume":" ","pages":"84-86"},"PeriodicalIF":13.4,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40380428","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Determinations of Competence Ought Not to Be Primarily Grounded in Paternalistic Justifications regarding Welfare.","authors":"Hojjat Soofi, Anson Fehross","doi":"10.1080/15265161.2022.2110983","DOIUrl":"https://doi.org/10.1080/15265161.2022.2110983","url":null,"abstract":"appropriate authority, not the other way around. And this is indeed a serious concern. If facts about competence can’t justify giving or withholding authority, then there doesn’t seem to be any significant practical role for them to play. To preserve competency’s justificatory role, an externalist would have to insist that competence is determined independently of whether all-things-considered the patient should have authority over the choice at hand. But on such a view, it’s mysterious why facts about the harmfulness of a decision should make it the case that a certain degree of capacity is required for competence. So it’s not clear how the constitutive account can avoid the worry that motivates Pickering et al. to reject it. In summary, while Pickering et al. highlight important tensions in the case of C, as well as in the practice of assessing competency more generally, their proposed account faces serious difficulties. To begin with, recall that if their explanatory account is intended to be an externalist account of competence judgments (rather than competence itself), then it fails to engage with the internalist/ externalist debate as standardly conceived. Alternatively, if their account is meant to vindicate a form of externalism (standardly conceived), then it’s not clear exactly what explanatory connection between welfare and competence they have in mind. If it’s a mere causal connection between diminished capacity and harmful decisions, then their explanatory account reduces to the indicative account and fails to rule out internalism. If, on the other hand, welfare considerations (partly) explain why a certain threshold of capacity is sufficient for competence, then their explanatory account collapses into a kind of constitutive account they reject. So, ultimately, we’re skeptical that Pickering et al. have succeeded in defending a distinctive externalist account of competency.","PeriodicalId":145777,"journal":{"name":"The American journal of bioethics : AJOB","volume":" ","pages":"75-78"},"PeriodicalIF":13.4,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40380432","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"External Dynamics Contextualizing the FDA's Role in E-Cigarette Regulation.","authors":"Omar Gaidarov, Rachel Asher","doi":"10.1080/15265161.2022.2110969","DOIUrl":"https://doi.org/10.1080/15265161.2022.2110969","url":null,"abstract":"The authors of the target article articulate the complicated, often conflicting demands of U.S. Food and Drug Administration (FDA) roles as justification for the FDA’s delay in releasing guidelines and health-related safety information regarding e-cigarette consumption. However, despite emphasizing that “The FDA’s actions should not be taken in a historical or social vacuum” (Svirsky, Howard, and Berman 2022, 8) the authors fail to contextualize current e-cigarette regulatory decisions in the rich, recent history of Big Tobacco regulation. A critical examination of these intertwined sociopolitical and industrial forces which act upon the FDA and shape the regulatory landscape is necessary to understand the authors’ proposed roles. When the authors say, “The point here is not to paint the e-cigarette industry as similarly vicious or manipulative” relative to Big Tobacco (Svirsky, Howard, and Berman 2022, 8), they not only fail to view the two as connected, but explicitly communicate the opposite. Their description is ambiguous and misleading, implying that the e-cigarette industry exists as a separate entity from Big Tobacco. In the current industry landscape, every Big Tobacco company owns at least one e-cigarette brand (Gelder 2022). Juul and Vuse, the two most popular e-cigarette brands in the US by market share, are owned by Big Tobacco: Altria Group purchased a 35% stake in Juul in 2018, and Vuse is owned by Reynolds American Tobacco (Gelder 2022). Given these enmeshed corporate alliances, a more nuanced examination of the FDA’s roles requires specification of the e-cigarette/Big Tobacco industrial complex, its relationship to the FDA, and the remarkable ways in which this entity has shaped its own regulation. The impact of the authors’ neglect of this context is particularly glaring in their description of the FDA as a unidirectional Market Agent. The FDA historically has had the regulatory ability to shift the free-market environment, and evaluating its decision-making in that context is important. However, we must acknowledge that this role is fundamentally bidirectional, so-far-as the government’s ability to effectively regulate is contingent upon market cooperation. This is especially true in the case of e-cigarette regulation and the Altria Group as Altria, the previously introduced stakeholder in Juul, was crucially involved in the legislation behind the 2009 Tobacco Control Act through its subsidiary Phillip Morris (Barker 2009). Their active involvement in regulatory decision-making, as well as their global rebrand to the Altria Group from Phillip Morris, were means by which to distance the company from the successful public health campaigns against combustible tobacco use in the late 20th century (Barker 2009). In 2009, Altria only acquiesced to and ultimately supported federal intervention when it was able to create a favorable regulatory environment that boosted credibility (Barker 2009, 200). Through the years leading up to the a","PeriodicalId":145777,"journal":{"name":"The American journal of bioethics : AJOB","volume":" ","pages":"32-34"},"PeriodicalIF":13.4,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40380424","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Stepping Up or Stepping Back: FDA Roles in Producing and Shaping Knowledge of Pediatric Covid-19 Vaccines.","authors":"Elizabeth Lanphier, Sophia Bessias","doi":"10.1080/15265161.2022.2110970","DOIUrl":"https://doi.org/10.1080/15265161.2022.2110970","url":null,"abstract":"We agree with Svirsky, Howard, and Berman (2022) that the US Food and Drug Administration (FDA) plays various roles, only one of which is the technical review and evaluation of product safety and efficacy. The authors suggest that in addition to this role as knowledge purveyor, the FDA ought to be sensitive to its roles as knowledge producer (creating new knowledge through its review process), advisor (communicating knowledge that it creates or assesses), and market agent (“shaping the market conditions in which people make health related choices”) when issuing decisions. We agree that each are roles the FDA may play implicitly, if not explicitly. But we question whether each role is appropriate to the agency in all cases, especially when other agencies may have more relevant expertise or authority to fulfill certain roles. We show that comparing the FDA’s roles in ecigarette regulation to the FDA’s roles in pediatric Covid-19 vaccine authorization adds nuance to the authors’ conclusions, suggesting important differences in the FDA’s role(s) depending on the type of product it is reviewing and the availability and appropriateness of other agencies, such as the Centers for Disease Control and Prevention (CDC), to fulfill certain of these roles. Specifically, the example of pediatric Covid-19 vaccine FDA review suggests that the FDA’s ancillary roles may have overshadowed its core evaluation functions. KNOWLEDGE PURVEYOR","PeriodicalId":145777,"journal":{"name":"The American journal of bioethics : AJOB","volume":" ","pages":"26-28"},"PeriodicalIF":13.4,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40380444","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Identity and Liberalism in Public Health: A Response to the Open Peer Commentaries.","authors":"Hafez Ismaili M'hamdi","doi":"10.1080/15265161.2021.1974977","DOIUrl":"https://doi.org/10.1080/15265161.2021.1974977","url":null,"abstract":"I would like to thank all who have taken the time to read and comment on my target article in which I compare state neutrality and perfectionism as approaches to justify public health policy and argue that perfectionism is the most promising approach (Ismaili M’hamdi 2021). The article has yielded seven commentaries. It is impossible for me to do justice to the commentators within the limits of this response. Given that criterion (d) of the liberal proviso, the role of identity and my description of state neutrality and liberalism elicited the most attention and critique I will focus on these topics.","PeriodicalId":145777,"journal":{"name":"The American journal of bioethics : AJOB","volume":" ","pages":"W1-W5"},"PeriodicalIF":13.4,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39472656","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"E-Cigarettes and the Multiple Responsibilities of the FDA.","authors":"Larisa Svirsky,&nbsp;Dana Howard,&nbsp;Micah L Berman","doi":"10.1080/15265161.2021.1907478","DOIUrl":"https://doi.org/10.1080/15265161.2021.1907478","url":null,"abstract":"<p><p>This paper considers the responsibilities of the FDA with regard to disseminating information about the benefits and harms of e-cigarettes. Tobacco harm reduction advocates claim that the FDA has been overcautious and has violated ethical obligations by failing to clearly communicate to the public that e-cigarettes are far less harmful than cigarettes. We argue, by contrast, that the FDA's obligations in this arena are more complex than they may appear at first blush. Though the FDA is accountable for informing the public about the health risks and benefits of products it regulates, it also has other roles (and attendant responsibilities) that inform when and how it should disseminate information. In addition to being a knowledge purveyor, it is also a knowledge producer, an advisor to the public, and a practical agent shaping the material conditions in which people make health-related choices. In our view, those other roles call for caution in the way the FDA interprets and communicates the available evidence.</p>","PeriodicalId":145777,"journal":{"name":"The American journal of bioethics : AJOB","volume":" ","pages":"5-14"},"PeriodicalIF":13.4,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/15265161.2021.1907478","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38892818","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}