Evaluating industry attempts to influence public health: Applying an ethical framework in understanding commercial determinants of health.

Objectives: This paper explores industry influence on public health using a specific case study and applies an established ethical framework based on eleven principles to explore Commercial Determinants of Health (CDoH). It demonstrates an application of these principles to evaluate the ethical integrity of industry strategies and practices and their impacts on public health. Methods: Using eleven a priori, deductive, ethical principles as codes, this paper conducted an in-depth analysis of 19 e-mail chains and accompanying documents made publicly available through the Freedom of Information Act (FOIA) from U.S. Right to Know (USRTK) sent between Coca-Cola representatives, lobbyists, academics, and the International Life Sciences Institute (ILSI), founded by former Coca-Cola executives. Results: The three principles violated most frequently amongst the documents were consumer sovereignty (n = 22), evidence-informed actions (n = 21), and transparency (n = 20). Similarly, codes that featured most regularly across documents were transparency (13 out of 19 documents), consumer sovereignty (13 out of 19 documents), evidence-informed actions (9 out of 19 documents), and social justice and equity (9 out of 19 documents). All eleven principles were applied at least four times throughout the documents; however, responsiveness (z = 12), moral responsibility (z = 16), and holism (z = 30) were the least relevant to the data set. Conclusions: This case study of Coca-Cola demonstrates the usefulness of this ethics framework in reviewing actions of corporate actors in the promotion of products that are harmful to human health. It shows that the industry at times has low ethical integrity in their various strategies and practices to promote their products despite the negative impacts of these products on public health.

COVID-19 vaccine mandate for healthcare workers in the United States: a social justice policy.

INTRODUCTION: Vaccination is the most effective strategy to mitigating COVID-19 and restoring societal function. As the pandemic evolves with no certainty of a herd immunity threshold, universal vaccination of at-risk populations is desirable. However, vaccine hesitancy threatens the return to normalcy, and healthcare workers (HCWs) must embrace their ambassadorial role of shoring up vaccine confidence. Unfortunately, voluntary vaccination has been suboptimal among HCWs in the United States, a priority group for whom immunization is essential for maintaining health system capacity and the safety of high-risk patients in their care. Consequently, some health systems have implemented mandates to improve compliance. AREAS COVERED: This article discusses the ethical and practical considerations of mandatory COVID-19 vaccination policies for HCWs utilizing some components of the World Health Organization's framework and the unique context of a pandemic with evolving infection dynamics. EXPERT OPINION: COVID-19 vaccine mandates for universal immunization of HCWs raise ethical and practical debates about their appropriateness, especially when the vaccines are pending full approval in most jurisdictions. Given the superiority of the vaccines to safety and testing protocols and their favorable safety profile, we encourage health systems to adopt vaccination mandates through participatory processes that address the concerns of stakeholders.

Commercial determinants of health: an ethical exploration.

OBJECTIVES: This paper seeks to contribute toward a better understanding of commercial determinants of health by proposing a set of ethical principles that can be used by researchers and other health actors in understanding and addressing Commercial Determinants of Health (CDoH). METHODS: The paper is mainly based on a systematic review and qualitative analysis of the existing literature on CDoH and public health ethics frameworks. We conducted searches using selected search engines (Google Scholar and Pubmed). For ethical challenges relating to CDOH, our searches in Google Scholar yielded 17 papers that discussed ethical challenges that affect CDoH. For ethical frameworks relevant for CDOH, our searches in Google Scholar and Pubmed yielded 15 papers that clearly described bioethical models including relevant ethical principles. Additionally, we consulted eight experts working on CDoH. Through these two methods, we were able to identify ethical challenges as well as norms and values related to CDoH that we offer as candidates to comprise a foundational ethics framework for CDoH. RESULTS: Discussing risk factors associated with CDH frequently brings public health into conflict with the interests of industry actors in the food, automobile, beverage, alcohol, ammunition, gaming and tobacco industries including conflict between profit-making and public health. We propose the following candidate ethical principles that can be used in addressing CDoH: moral responsibility, nonmaleficence, social justice and equity, consumer sovereignty, evidence-informed actions, responsiveness, accountability, appropriateness, transparency, beneficence and holism. CONCLUSIONS: We hope that this set of guiding principles will generate wider global debate on CDoH and help inform ethical analyses of corporate actions that contribute to ill health and policies aimed at addressing CDoH. These candidate principles can guide researchers and health actors including corporations in addressing CDoH.

How Should Vaccine Campaigns Balance Need for Clear Communication Against Need for Timely Administration of Large-Scale Programs?

Limited understanding of public health disease prevention programs often leads to resistance, which ultimately results in low vaccine uptake. This article suggests how public health practitioners can improve public understanding of cervical cancer and HPV vaccination programs, which is key to improving health literacy, using culturally appropriate materials and approaches to boost public acceptance of vaccine programs.

Study participants incentives, compensation and reimbursement in resource-constrained settings.

INTRODUCTION: Controversies still exists within the research fraternity on the form and level of incentives, compensation and reimbursement to study participants in resource-constrained settings. While most research activities contribute significantly to advancement of mankind, little has been considered in rewarding directly the research participants from resource-constrained areas. METHODS: A study was conducted in Zimbabwe to investigate views and expectations of various stakeholders on study participation incentives, compensation and reimbursement issues. Data was collected using various methods including a survey of about 1,008 parents/guardians of school children participating in various immunological cohort studies and parasitology surveys. Community advisory boards (CABs) at 9 of the sites were also consulted. Further, information was gathered during discussions held at a basic research ethics training workshop. The workshop had 45 participants that including 40 seasoned Zimbabwean researchers and 5 international research collaborators. RESULTS: About 90% (907) of the study participants and guardians expected compensation of reasonable value, in view of the researchers' value and comparison to other sites regardless of economic status of the community. During discussion with researchers at a basic ethics training workshop, about 80% (32) believed that decisions on level of compensation should be determined by the local research ethics committees. While, the few international research collaborators were of the opinion that compensation should be in accordance with local guidelines, and incentives should be in line with funding. Both the CAB members and study participants expressed that there should be a clear distinction between study incentive and compensation accorded to individual and community expectations on benefits from studies. However, CABs expressed that their suggestions on incentives and compensation are often moderated by the regulatory authorities who cite fear of unknown concerns. CONCLUSION: Overall, both personal and community benefits need to be considered collectively in future studies to be conducted in resource-constrained communities. There is projected fear that recruitment in future may be a challenge, now that almost every community, has somehow been reached and participated in some form of studies. A major concern on reimbursement, compensation or incentives should be internationally pegged regardless of different economic status of the individuals or communities where the study is to be conducted.

Infant feeding and HIV in Sub-Saharan Africa: what lies beneath the dilemma?

The debate over how to best guide HIV-infected mothers in resource-poor settings on infant feeding is more than two decades old. Globally, breastfeeding is responsible for approximately 300,000 HIV infections per year, while at the same time, UNICEF estimates that not breastfeeding (formula feeding with contaminated water) is responsible for 1.5 million child deaths per year. The largest burden of these infections and deaths occur in Sub-Saharan Africa. Using this region as an example of the burden faced more generally in other resource-poor settings, we contrast the evolution of the clinical standard of care for infant feeding with HIV-infected mothers in high-income countries to the current international clinical guidelines for HIV-infected mothers and infant feeding in resource-poor settings. While the international guidelines of exclusive breastfeeding for a 6-month period seem to offer the least-worst strategy for reducing mother-to-child transmission of HIV during infancy while conferring some immunity through breastfeeding post-6 months, we argue that the impact of the policy on mothers and healthcare workers on the ground is not well understood. The harm reduction approach on the level of health policy translates into a complicated, painful moral dilemma for HIV-positive mothers and those offering them guidance on infant feeding. We argue that the underlying socio-economic disparities that continue to fuel the need for a harm reduction policy on infant feeding and the harm to women and children justify: (1) that higher priority be given to solving the infant feeding dilemma with improved data on safe feeding alternatives, and (2) support of innovative, community-driven solutions that address the particular economic and cultural challenges that continue to result in HIV-transmission to children within these communities.

Why do individuals agree to enrol in clinical trials? A qualitative study of health research participation in Blantyre, Malawi.

Current literature suggests that therapeutic misconception a belief by participants in a clinical trial that they are in fact simply being given clinical care is common, especially among illiterate populations in developing countries. Therapeutic misconception reects problems in informed consent, as people agree to participate in clinical trials without being aware that the trial procedures and test products may not in fact benet them. In this study of Malawian adults who had participated in research projects of various kinds during the preceding years, we found that the majority participated in research for the sake of obtaining better quality treatment made available through the clinical trials as ancillary care. Their consent to participate was not due to a belief that the actual procedures of the trial would directly benet their health. Respondents indicated that, government hospitals being crowded and commonly lacking drugs, they agreed to take part in research projects in the hope of obtaining access to ancillary care provided by clinical trials. We conclude that in this environment, possibly owing to inadequacy of routine health services, people make rational decisions to participate in research. We question whether the term therapeutic misconception accurately describes participants motivation under conditions of limited resources. We also discuss the relevance of these ndings for understanding undue inducement in clinical trials.

Compensating clinical trial participants from limited resource settings in internationally sponsored clinical trials: a proposal.

Trial participants from limited resource settings often are given very little or nothing in terms of compensation for time, inconvenience and risks as compared to their counterparts from developed countries. The reason that is often sited by researchers, ethics committees, and sponsors is the avoidance of undue inducements. We discuss the inherent conflict that may arise in trying to avoid undue inducement and in trying to minimize injustice in international research. We argue that research participants from both industrialized nations and those from limited resource settings should be compensated equally since they suffer the same burdens and equally contribute towards the study by contributing the same product data. We make recommendations that acknowledge and address the existing injustice in the compensation of trial participants in international research.

Why do people refuse to take part in biomedical research studies? Evidence from a resource-poor area.

Participants refusal to take part in research is an unpleasant experience that investigators face. This paper highlights some of the reasons why people from resource-poor settings refuse to take part in health research. This paper also highlights standards which investigators can adopt to avoid unnecessary refusals and at the same time ensure that individuals have the right to participate and freedom to refuse. Our objective was to explore reasons why people refuse to join research studies. We conducted focus group discussions with people who had refused to take part in a number of biomedical research studies but agreed to be interviewed in this study. The study was undertaken in the peri-urban and urban areas of Blantyre district; Bangwe, Mpemba and Madziabango. We found nine key factors that influence people to refuse to participate in biomedical research. The factors are failure to follow traditional customs, lack of study benefits, superstition, poor informed consent procedures, ignorance of health research, fear of strangers, lack of cultural sensitivity, poor timing, and previous bad research experience. People refuse to participate in health research for a number of reasons which can be overcome if researchers embark on community engagement before implementing their studies.

Will developing countries benefit from their participation in genetics research?

There is an increase in the amount of genetics research being conducted in both developed and limited resource countries. Most of this research is sponsored by developed countries. There are concerns in limited resource countries on how the benefits from this research are currently being shared or will be shared in the future. There is need for caution, to ensure that populations from limited resource countries are not exploited by being used as subjects in genetics research which is meant to benefit populations from developed countries. This paper addresses the issue of fairness in benefits sharing and argues for justice in the sharing of both burdens and benefits of genetics research. The paper responds to some of the issues and arguments in recent literature on the meaning and limits of the concept of benefit sharing in human genetics research.