Inequity in access to vaccines: the failure of the global response to the COVID-19 pandemic.

This article summarizes the strategies used to rapidly develop COVID-19 vaccines and distribute them globally, with an emphasis on vaccines developed in western nations. It is based on interviews and information gathered regarding the response to the pandemic, both from international organizations and official documents from Brazil, Argentina, Colombia, Peru, and Mexico. While vaccine development has been hailed as successful, their global distribution has been highly unequal.

Un ensayo clínico no ético y la politización de la pandemia de COVID-19 en Brasil: El caso de Prevent Senior.

El Senado Federal de Brasil creó una Comisión Parlamentaria de Investigación (CPI) para investigar las irregularidades del gobierno de Bolsonaro en la gestión de la pandemia de COVID-19. Uno de los casos que llamó la atención fue la investigación llevada a cabo por Prevent Senior, una empresa privada de seguros de salud, sobre el tratamiento temprano de COVID-19. Este artículo analiza la validez científica de la investigación y los problemas éticos relacionados con su implementación.

Uma pesquisa clínica não ética e a politização da pandemia da COVID-19 no Brasil: o caso da Prevent Senior.

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.

An unethical trial and the politicization of the COVID-19 pandemic in Brazil: The case of Prevent Senior.

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.

The Associations Between Breastfeeding Duration and Body Dissatisfaction, Ethnicity, and Obesity Among Mexican Women, a Cross-Sectional Study, ENSANUT 2012.

Body image dissatisfaction (BID) has been inversely associated with breastfeeding initiation particularly among women with obesity. However, less is known on BID and the association with maintaining breastfeeding in Mexico, where breastfeeding rate is decreasing across ethnic subgroups. Therefore, we explore this gap of knowledge in diverse ethnic subgroups across levels of maternal weight status.

A commentary on 'A systematic review examining the association between body image and infant feeding methods (breastfeeding vs. bottle-feeding)'.

A systematic review is a valuable and influential research method that aims to identify and synthesize all literature relevant to the research question at hand. A well-conducted systematic review benefits the scientific community by providing a summary of all the existing evidence as well as generating new hypotheses and highlighting gaps in the literature. However, when a systematic review does not adhere to the recommended guidelines, it may introduce selection bias and generate false conclusions.

Acculturation and Breastfeeding Among Hispanic American Women: A Systematic Review.

Introduction Hispanic immigrants are more likely to breastfeed than are Hispanics born in the US, in part due to their acculturation. This paper aims to systematically review the existing literature on the association between acculturation and Hispanics' breastfeeding behaviors. Methods The systematic search used major databases such as Medline and PubMed, and it followed the PRISMA checklist.

Body Image Dissatisfaction, Obesity and Their Associations with Breastfeeding in Mexican Women, a Cross-Sectional Study.

Introduction In Mexico the breastfeeding rate is low and the obesity rate is high. Body image concerns, particularly prevalent in obese women, are associated with low breastfeeding rate; however, this association has never been examined in Mexican women. To fill this need, we examined the association between body image dissatisfaction (BID) and breastfeeding across levels of maternal weight status in Mexican women.

A Missing Piece in Clinical Trial Inspections in Latin America: Interviews With Research Subjects in Peru.

Most regulatory agencies conduct clinical trial (CT) site inspections, but the experiences and behaviors of research subjects and their knowledge of the rights and obligations that ensue from participating in a CT are seldom explored. The authors assessed the technical feasibility of incorporating interviews with participants in CT inspections. This article analyzes the responses of 13 CT participants, 14% ( n = 96) of those included in three tuberculosis (TB) CTs.

Clinical trials in Latin America: implications for the sustainability and safety of pharmaceutical markets and the wellbeing of research subjects.

This study sought to verify whether drugs approved by the US Food and Drug Administration (FDA) were registered, commercialized and sold at affordable prices in the Latin American countries where they had been tested, as well as to ascertain their contribution to the quality of the pharmaceutical market. The list of New Molecular Entities (NMEs) approved by the FDA in 2011 and 2012 was consulted to determine the countries where pivotal trials were conducted. Affordability was assessed as a proportion of income and information on safety and efficacy was gathered from independent drug bulletins.

Health and Ethical Consequences of Outsourcing Pivotal Clinical Trials to Latin America: A Cross-Sectional, Descriptive Study.

Introduction: The implications of conducting clinical trials in low and middle income countries on the financial accessibility and safety of the pharmaceutical products available in those markets have not been studied. Regulatory practices and ethical declarations lead to the commercialization of the new products, referred to as New Molecular Entities (NMEs), in the countries where tested as soon as they are approved in high surveillance countries. Patients and patients' associations use the Latin American courts to access new and expensive treatments, regardless of their safety profile and therapeutic value.

Lost to follow-up: failure to engage children in care in the first three months of diagnosis.

Loss to follow-up (LTFU) is a critical factor in determining clinical outcomes in HIV treatment programs. Identifying modifiable factors of LTFU is fundamental for designing effective patient-retention interventions. We analyzed factors contributing to children LTFU from a treatment program to identify those that can be modified.

Are Private Interests Clouding the Peer-Review Process of the WHO Bulletin? A Case Study.

Readers' trust on the medical literature has been eroded, and journal editors and some editorial boards are taking measures to ensure that authors fully and accurately report research findings and disclose conflicts of interest. This article describes a case study in which the papers editor of the World Health Organization (WHO) Bulletin influenced the content of an article that had been approved by the external reviewers. The editor objected to the publication of the large price differentials of the new molecular entities (NMEs) across the Latin American countries where they had been tested and the limited added therapeutic value of the NMEs that had been assessed by independent drug bulletins.

Availability and affordability of new medicines in Latin American countries where pivotal clinical trials were conducted.

Objective: To assess whether new pharmaceutical products approved by the United States Food and Drug Administration (FDA) in 2011 and 2012 were registered, commercialized and sold at affordable prices in the Latin American countries where they were tested.

Methods: We obtained a list of new molecular entities (new pharmaceutical products) approved by the FDA in 2011 and 2012. FDA medical reviews indicated the countries where pivotal clinical trials had been conducted.

Impact of global health governance on country health systems: the case of HIV initiatives in Nigeria.

Background: Three global health initiatives (GHIs) - the US President's Emergency Plan for AIDS Relief, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and the World Bank Multi-Country HIV/AIDS Program - finance most HIV services in Nigeria. Critics assert that GHIs burden fragile health systems in resource-poor countries and that health system limitations in these countries constrain the achievement of the objectives of GHIs. This study analyzed interactions between HIV GHIs and the Nigerian Health System and explored how the impact of the GHIs could be optimized.

[The impact of researchers loyal to Big Pharma on the ethics and quality of clinical trials in Latin America].

This article explains the difficulties innovative pharmaceutical firms have in repaying shareholders with attractive dividends. The problem is the result of the expiration of the patents of blockbuster drugs and the difficulties that the firms have in bringing new blockbuster drugs to the market. One of the solutions companies have found has been to accelerate the implementation of clinical trials in order to expedite the commercialization of new drugs.

Unintended birth among Hispanic women in Texas: a descriptive analysis.

Unintended birth is associated with adverse maternal and infant outcomes. In 2006, US Hispanics had the highest unintended birth rate (45 births/1,000 women) compared to other groups. One-fifth of US Hispanic women reside in Texas, yet unintended birth among Texas Hispanics has not been studied.

The evaluation of complex clinical trial protocols: resources available to research ethics committees and the use of clinical trial registries--a case study.

Objectives: To assess the potential role of clinical trial (CT) registries and other resources available to research ethics committees (RECs) in the evaluation of complex CT protocols in low-income and middle-income countries.

Methodology: Using a case study approach, the authors examined the decision-making process of a REC in Argentina and its efforts to use available resources to decide on a complex protocol. We also analysed the information in the USA and other CT registries and consulted 24 CT experts in seven countries.

Mexican pharmacies: benefits and risks for border residents in the United States of America and Mexico.

Objective: To determine the benefits and risks of using Mexican pharmacies by better understanding the sociodemographics and medication needs of pharmacy clients in Ciudad Juárez; and to ascertain the role and expertise of pharmacy clerks and their impact on medication use.

Methods: Cross-sectional study of a convenience sample of 32 pharmacies in Ciudad Juárez conducted in August 2007-January 2008. Medical professionals interviewed 230 pharmacy clients and 25 pharmacy owners and clerks, and observed 152 clerk-client interactions.

Mexican Pharmacies and Antibiotic Consumption at the US-Mexico Border.

Objective: To study antibiotic dispensing to US and Mexican residents, at Mexican pharmacies at the US-Mexico border, and the pharmacy clerks' capability to promote appropriate use.

Methods: The site selected was Ciudad Juarez, Chihuahua (pop. 1.

Putting contract research organisations on the radar.

There is a trend for pharmaceutical companies to contract third parties to conduct the clinical trials that are needed to test their drugs. This trend is referred to as , and the companies that carry out the work are called contract research organisations. In addition, clinical trials are increasingly conducted in non-traditional trial regions, which are mainly low- and middle-income countries.