{"title":"Uma pesquisa clínica não ética e a politização da pandemia da COVID-19 no Brasil: o caso da Prevent Senior","authors":"Fernando Hellmann, Núria Homedes","doi":"10.1111/dewb.12369","DOIUrl":"10.1111/dewb.12369","url":null,"abstract":"<div>\u0000 \u0000 <p>O Senado Federal brasileiro criou uma Comissão Parlamentar de Inquérito (CPI) para investigar as irregularidades do governo Bolsonaro na gestão da pandemia da COVID-19. Um dos casos que chamou a atenção foi a pesquisa realizada pela Prevent Senior, uma seguradora privada de saúde, sobre o tratamento precoce da COVID-19. O artigo analisa a validade científica da pesquisa e os problemas éticos relacionados à sua implementação. Baseia-se na análise do relatório do ensaio clínico da Prevent Senior, dos registros do ensaio clínico em plataformas do Brasil e dos EUA, do relatório da CPI do Senado e nas informações divulgadas pela mídia. Esse caso de fraude científica e viés político-ideológico exemplifica como a Prevent Senior, usando um protocolo questionável para melhorar sua reputação e ganhar o apoio do governo, foi fundamental na construção da narrativa do “tratamento precoce” para a COVID-19, e mostra como serviu de base para uma política pública governamental que promoveu o uso de drogas ineficazes.</p>\u0000 </div>","PeriodicalId":50590,"journal":{"name":"Developing World Bioethics","volume":"24 3","pages":"217-230"},"PeriodicalIF":0.9,"publicationDate":"2022-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40352933","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Ethical Progress on the Abortion Care Frontiers on the African Continent","authors":"Udo Schuklenk","doi":"10.1111/dewb.12364","DOIUrl":"10.1111/dewb.12364","url":null,"abstract":"<p>The Supreme Court of the United States of America has overridden 50 years of legal precedent and reversed constitutional protections1 for abortion in the country that were the result of the 1973 landmark Roe v Wade ruling. Pregnant women in the country do not enjoy a constitutional right to abortion any longer. Broadly speaking the result of this ruling results in a split of the country in terms of access to abortion care based on whether a woman lives in a Republican party controlled state or a Democratic party controlled state. The verdict has been widely condemned by associations of health care professionals, medical journals and the like, as much as it was celebrated by religious leaders like the Pope.2,3 None of that is terribly surprising.</p><p>Among secular bioethicists support for liberal access to abortion care has always been strong. The main ethical reasons for this have to do with respecting women's rights to control over their own bodies,4 as well as consequentialist ethical reasons that take cognizance of worse health care outcomes for the most vulnerable women in societies where restrictive access to abortion care regimes are in place.5 The liberalization of laws on abortion, on the other hand, has demonstrably led to improved health outcomes for these women.6 The ethical arguments on abortion have been debated endlessly by bioethicists, and there is little point in rehashing them here in any great detail.7</p><p>What is perhaps worth noting is that – unlike in the United States – access to abortion care has become in recent years easier in a number of countries on the African continent, including some of its very poorest. Much of this is the result of the so-called Maputo Protocol, or, more formally, the African Union's Protocol to the African Charter on Human and Peoples’ Rights on the Rights of Women in Africa.8 Since the Maputo Protocol came into effect in 2005, seven sub Saharan countries have taken steps to liberalise their abortion related legislation in order to bring their laws in line with the Protocol. To give just a few examples, since 2012 Benin is permitting abortion care even for economic and social reasons up to the 12<sup>th</sup> week after conception. Cape Verde permits abortion on demand up to the 12<sup>th</sup> week after conception, too. The Democratic Republic of Congo has taken to publishing the full text of the Protocol in the government gazette, thereby making it law.9 The result of this has been truly sweeping changes liberalizing the country's abortion regime. Sierra Leone's government introduced a bill in the country's parliament that would, if passed, decriminalize abortion, and expand access to contraceptives as well as other reproductive health services. While this won't change the country's staggeringly high maternal deaths’ rate of around 10% over night, that is a result of unsafe abortion practices, it is an important start to bring about much needed change.10</p><p>Much more needs to be done","PeriodicalId":50590,"journal":{"name":"Developing World Bioethics","volume":"22 3","pages":"125"},"PeriodicalIF":2.2,"publicationDate":"2022-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/dewb.12364","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40346061","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Regulation concerns of supply and demand sides for aesthetic medicine from Chinese perspective","authors":"Longfei Feng, Xiaomei Zhai","doi":"10.1111/dewb.12366","DOIUrl":"10.1111/dewb.12366","url":null,"abstract":"<p>Aesthetic medicine has become a booming industry in the world. However, there are widespread social and health risks posed by aesthetic medicine, including illegal practice, and misleading information from aesthetic medicine institutes. Social media and advertisement play important roles in leading to appearance anxiety among young people nowadays. Regarding the chaotic situation in the aesthetic medical field, there is a fact that the practice of aesthetic medicine has been marginally regulated, even in some developed countries. China has the largest population in the world as well as the large number of aesthetic medical customers. Regarding the protection of people from harm, there is a great challenge for the Chinese government. So, China has enacted the <i>toughest governance</i> these years both on the supply and demand side. Some of the strategies may be useful for health authorities in certain countries.</p>","PeriodicalId":50590,"journal":{"name":"Developing World Bioethics","volume":"23 3","pages":"277-284"},"PeriodicalIF":2.2,"publicationDate":"2022-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10186712","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Obstetric violence as immigration injustice: A view from the United States and Colombia","authors":"Allison B. Wolf","doi":"10.1111/dewb.12365","DOIUrl":"10.1111/dewb.12365","url":null,"abstract":"<p>In September 2020, Project South, along with numerous other organizations, released a report detailing abuses in a Georgia Detention Center – including forced hysterectomies. Whatever other factors are at play, one of them is an intrinsic connection between obstetric violence against pregnant migrants and immigration injustice. It is not incidental that these acts – in US detention centers, along the US-Mexico border, in Colombian hospitals and clinics – are being perpetrated on immigrant bodies. And it is not accidental or random which immigrant bodies are vulnerable to these violations. Understanding and confronting obstetric violence directed at pregnant migrants, though, requires reconceptualizing the nature of obstetric violence itself. In particular, we must recognize that obstetric violence against pregnant Latin American migrants in the United States and Colombia is a type of immigration injustice, a means to perpetrate immigration injustice, and a product of immigration injustice. As such, bioethicists need to collaborate with immigration scholars to resist it.</p><p>After providing some background on the nature of obstetric violence and some ways it is perpetuated against pregnant migrants in the United States and Colombia, I will give a brief overview of how I conceptualize immigration justice. From there, I explain how this type of obstetric violence constitutes a type of immigration injustice, a means to perpetrate immigration injustice, and a product of immigration injustice. My hope is that this analysis motivates bioethicists throughout the Americas to engage with immigration scholars and activists to confront the issue more forcefully.</p>","PeriodicalId":50590,"journal":{"name":"Developing World Bioethics","volume":"23 2","pages":"176-184"},"PeriodicalIF":2.2,"publicationDate":"2022-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10033745","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sarah J. L. Edwards, Blessing Silaigwana, Danny Asogun, Julius Mugwagwa, Francine Ntoumi, Rashid Ansumana, Kevin Bardosh, Jennyfer Ambe
{"title":"An ethics of anthropology-informed community engagement with COVID-19 clinical trials in Africa","authors":"Sarah J. L. Edwards, Blessing Silaigwana, Danny Asogun, Julius Mugwagwa, Francine Ntoumi, Rashid Ansumana, Kevin Bardosh, Jennyfer Ambe","doi":"10.1111/dewb.12367","DOIUrl":"10.1111/dewb.12367","url":null,"abstract":"<p>The COVID-19 pandemic has reinforced the critical role of ethics and community engagement in designing and conducting clinical research during infectious disease outbreaks where no vaccine or treatment already exists. In reviewing current practices across Africa, we distinguish between three distinct roles for community engagement in clinical research that are often conflated: 1) the importance of community engagement for identifying and honouring cultural sensitivities; 2) the importance of recognising the socio-political context in which the research is proposed; and 3) the importance of understanding what is in the interest of communities recruited to research according to their own views and values. By making these distinctions, we show that current practice of clinical research could draw on anthropology in ways which are sometimes unnecessary to solicit local cultural values, overlook the importance of socio-political contexts and wider societal structures within which it works, potentially serving to reinforce unjust political or social regimes, and threaten to cast doubt on the trustworthiness of the research. We argue that more discerning anthropological engagement as well as wider collaboration with other social scientists and those working in the humanities is urgently needed to improve the ethics of current biomedical and pharmaceutical research practice in Africa.</p>","PeriodicalId":50590,"journal":{"name":"Developing World Bioethics","volume":"23 3","pages":"242-251"},"PeriodicalIF":2.2,"publicationDate":"2022-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9538500/pdf/DEWB-9999-0.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10239910","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Reflections on research ethics in a public health emergency: Experiences of Brazilian women affected by Zika","authors":"Ilana Ambrogi, Luciana Brito, Sergio Rego","doi":"10.1111/dewb.12361","DOIUrl":"10.1111/dewb.12361","url":null,"abstract":"<p>In Brazil, the epicenter of the Zika crisis, brown, black, and indigenous poor women living in municipalities with scarce resources were disproportionally affected. The gendered consequences of the epidemic exposed how intersectional lenses are central to understand the impact of public health emergencies in the lives of women and girls. The demand for Zika-affected children and women to be research participants is relevant for an ethical analysis of participant protection procedures during a crisis. We investigated how women experienced research participation by analyzing their narratives. Two-year-long longitudinal qualitative study in Brazilian sites located in the epidemic's epicenter was performed using mixed methods: ethnography with women from two distinct states and individual semi-structured interviews with five women in different Zika-affected states, four of which were community leaders. All women in the study were mothers or grandmothers of Zika-affected children. Thematic analysis was used for data evaluation. Women perceived being pressured to participate in research and a lack of benefit sharing. Structural determinants of gender inequality, such as its effect on power distribution, were found to impact research participant protection. Formal procedures for research protocols approvals were insufficient in protecting participants because these instruments were unable to account for structural aspects. Communitarian mobilization, through WhatsApp groups, was found to be an important mechanism to create conditions to challenge oppressive structures. Strengthening public health, effective community-based participation in research planning and implantation of ethical strategies that promotes gender equality can have transformative effect on unequal power structures and promote participant protection.</p>","PeriodicalId":50590,"journal":{"name":"Developing World Bioethics","volume":"23 2","pages":"138-146"},"PeriodicalIF":2.2,"publicationDate":"2022-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/dewb.12361","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9680931","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"An unethical trial and the politicization of the COVID-19 pandemic in Brazil: The case of Prevent Senior","authors":"Fernando Hellmann, Núria Homedes","doi":"10.1111/dewb.12363","DOIUrl":"10.1111/dewb.12363","url":null,"abstract":"<p>The Brazilian Federal Senate created a Parliamentary Inquiry Commission (CPI) to investigate the Bolsonaro government's irregularities in the management of the COVID-19 pandemic. One of the cases that drew attention was the research conducted by Prevent Senior, a private health insurance company, on the early treatment of COVID-19. The article analyzes the scientific validity of the research and the ethical problems related to its implementation. It is based on analysis of Prevent Senior's report of the clinical study, the Brazilian and USA clinical trial registries, the Senate's CPI report, and on the information reported by the media. This case of scientific fraud and political-ideological bias exemplifies how Prevent Senior, using a questionable protocol to enhance its reputation and gain government support, was instrumental in building the “early treatment” narrative for COVID-19, and shows how it served as a basis for a government public policy that promoted the use of ineffective drugs.</p>","PeriodicalId":50590,"journal":{"name":"Developing World Bioethics","volume":"23 3","pages":"229-241"},"PeriodicalIF":2.2,"publicationDate":"2022-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9349525/pdf/DEWB-9999-0.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10174525","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Is there a human right to essential health care?","authors":"Daniel M. Hausman","doi":"10.1111/dewb.12362","DOIUrl":"10.1111/dewb.12362","url":null,"abstract":"<p>In <i>Global Health Impact</i>, Nicole Hassoun joins the ranks of those defending a right to health. Unlike the World Health Organization, which views this right expansively, Hassoun would limit the right to the health needed to enjoy a minimally good life. This essay argues that this right is difficult to specify and insufficient to support the policies Hassoun defends. The essay sketches an alternative view of the obligations of institutions to address health problems that derives from imperfect individual duties to aid those who are doing badly or who are at risk of harm.</p>","PeriodicalId":50590,"journal":{"name":"Developing World Bioethics","volume":"24 1","pages":"6-9"},"PeriodicalIF":2.2,"publicationDate":"2022-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/dewb.12362","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40406946","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Ethical analysis of cadaver supply and usage processes for research within the scope of the Helsinki Declaration","authors":"Banu Buruk, Güneş Aytaç","doi":"10.1111/dewb.12360","DOIUrl":"10.1111/dewb.12360","url":null,"abstract":"<p>Recent technological developments have considerably transformed the supply, storage, and transportation processes of cadavers, creating new and previously unforeseen ethical challenges regarding cadaver usage. In this study, we analyzed two aspects of the cadaver processing system—cadaver supply and its use in research. Thereafter, we highlighted the major ethical concerns underlying these stages and correlated our search results with the ethical principles outlined in the Declaration of Helsinki (DoH), or Helsinki Declaration. To ensure the reliability and continuity of medical progress, human—especially cadaver—research depends on the ethical priorities as outlined in the DoH: respect for autonomy, privacy/confidentiality, risks/burdens/benefits, and the protection of vulnerable groups. According to our ethics analysis, which also corresponds with the ethics guidelines of the Consensus Panel on Research with the Recently Dead, the most ignored values were respect for autonomy and privacy/confidentiality issues. Based on these ethical concerns, we provide recommendations to address these challenges in anatomy research.</p>","PeriodicalId":50590,"journal":{"name":"Developing World Bioethics","volume":"23 3","pages":"211-219"},"PeriodicalIF":2.2,"publicationDate":"2022-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10181235","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"“By only considering the end product it means that our participation has always been in vain”: Defining benefits in HIV vaccine trials in Tanzania","authors":"Godwin Pancras, Mangi Ezekiel, David Nderitu, Bege Dauda, Erasto Vitus Mbugi","doi":"10.1111/dewb.12359","DOIUrl":"10.1111/dewb.12359","url":null,"abstract":"<p>Debates about what constitutes benefits in human research continue to be less informed due to a lack of empirical evidence from the developing world. This study aimed to explore what constitutes benefits in HIV vaccine trials in Tanzania and examine inherent ethical implications. A qualitative case study design was deployed and a total of 29 purposively selected study participants comprising of experienced researchers, institutional review board members and community advisory board members were included. Collected data were analyzed by thematic analysis aided by computer software: MAXQDA version 20.4.0. The study findings indicate that there is a growing appreciation of benefits beyond actual vaccines to include 1) capacity building at individual, community, institutional and regulatory levels; and 2) non-capacity building related benefits such as strengthened collaborations, ancillary care and employment opportunities. So, as the struggle for viable HIV vaccines continues, other benefits that have accrued from such trials are not to be blindsided especially for developing countries like Tanzania.</p>","PeriodicalId":50590,"journal":{"name":"Developing World Bioethics","volume":"23 3","pages":"220-228"},"PeriodicalIF":2.2,"publicationDate":"2022-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10181233","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}