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. 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.

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. Se basa en un análisis del informe del estudio clínico de Prevent Senior, de los registros de ensayos clínicos de Brasil y Estados Unidos, del informe de la CPI del Senado y de información difundida por los medios de comunicación. Este caso de fraude científico y sesgo político-ideológico ejemplifica cómo Prevent Senior, utilizando un protocolo cuestionable para mejorar su reputación y obtener el apoyo del gobierno, contribuyó a la construcción de la narrativa de "tratamiento temprano" para COVID-19, y muestra cómo sirvió de base para una política pública del gobierno que promovió el uso de medicamentos ineficaces.

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. 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.

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. Methods A cross-sectional study was used, utilizing data from the Mexican National Health and Nutrition Survey (ENSANUT) for 2012. The breastfeeding (Never or breastfed less than 30 days, Still breastfeeding, Ever breastfed) of the last child (age ≤ 3 years), BID (Stunkard Figure Rating Scale), anthropometric (Body Mass Index, BMI), and associated characteristics were collected. Weighted-multinomial logistic regression models were utilized to examine the adjusted association between BID and breastfeeding and the effect modification of maternal weight status. Results Overall, 2422 women aged 20-49 years met the eligibility criteria. Of these, 247 (10.8%) had never breastfed or breastfed less than 30 days, 826 (32%) were still breastfeeding, and 1349 (57.2%) had breastfed. A total of 38.2% were overweight (25 ≤ BMI < 30 kg m2) and 26.2% were obese (BMI ≥ 30 kg m2). In the adjusted model, while stratifying by maternal weight status levels, a greater BID was associated with a lower odds of sill breastfeeding (OR 0.58, 95% CI 0.45-0.75) and having breastfed (OR 0.65, 95% CI 0.50-0.83) only among women with BMI ≥ 30 kg m2. Discussion The results highlight the potential relationship between body image concerns and breastfeeding in Mexican women with obesity. However, the causality of such relationship needs further investigation, ideally using a longitudinal study design.

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. The scientific quality of the studies was rated using the Quality Assessment Tool for Quantitative Studies. Results We identified 1943 potential citations, of which 18 studies met the eligibility criteria. Overall, while 13 studies suggested that high-acculturated Hispanics were less likely to breastfeed compared with low-acculturated, five studies did not find significant evidence of such an association. Moreover, 12 studies used a static measure or a linear scale, which is not optimal; only three studies utilized bi/multidimensional scales to assess acculturation. Intention to breastfeed was examined in six studies, but the results were inconsistent. Breastfeeding initiation was examined in 11 studies, and two out of eight studies that examined breastfeeding duration, specifically analyzed exclusive breastfeeding at 6 months. Discussion Our results agree with the general hypothesis that higher acculturation is inversely related to breastfeeding rates, independently of income. Researchers used different methodologies to study acculturation and breastfeeding practices, limiting our ability to reach more detailed conclusions. Owing to the lack of a standard methodology for measuring acculturation, future studies should utilize bi/multidimensional scales when studying breastfeeding, in particular, in relation to breastfeeding intention and exclusive breastfeeding at 6 months; preferably according to Hispanic subgroups.

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. A case-control study involving 313 children was used to compare the sociodemographic and clinical characteristics of children LTFU (cases) with those remaining in care (controls) at a large pediatric HIV care setting in Botswana. We traced children through caregiver contacts and those we found, we conducted structured interviews with patients' caregivers. Children <5 years were nearly twice as likely as older children to be LTFU (57·8% versus 30·9%, p <0 .01). Approximately half (47·6%, n = 51) of LTFU patients failed to further engage in care after just one clinic visit, as compared to less than 1% (n = 2) in the control group (p < 0.01). Children LTFU were more likely than controls to have advanced disease, greater immunosuppression, and not to be receiving antiretroviral therapy. Among interviewed patient caregivers, psychosocial factors (e.g., stigma, religious beliefs, child rebellion, disclosure of HIV status) were characteristics of patients LTFU, but not of controls. Socioeconomic factors (e.g., lack of transportation, school-related activities, forgetting appointments) were cited predominantly by the controls. Pediatric patients and their caregivers need to be targeted and engaged at their initial clinic visit, with special attention to children <5 years. Possible interventions include providing psychosocial support for issues that deter patients from engaging with The Clinic. Collaboration with community-based organizations focused on reducing stigma may be useful in addressing these complex issues.

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. The registration status of the products was obtained from pharmaceutical registers; pharmaceutical companies confirmed their availability in national markets and local pricing observatories provided the price of medicines in retail pharmacies. Affordability was assessed as the cost of a course of treatment as a proportion of monthly income. Information on safety and efficacy was gathered from independent drug bulletins. FINDINGS: Of an expected 114 registrations, if the 33 products had been registered in all the countries where tested, only 68 (60%) were completed. Eight products were registered and commercialized in all countries but 10 had not been registered in any of the countries. With one exception, products for which we obtained pricing information (n = 18) cost more than the monthly minimum wage in all countries and 12 products cost at least five times the monthly minimum wage. CONCLUSION: Many pharmaceutical products tested in Latin America are unavailable and/or unaffordable to most of the population. Ethical review committees should consider the local affordability and therapeutic relevance of new products as additional criteria for the approval of clinical trials. Finally, clinical trials have opportunity costs that need to be assessed.

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. FINDINGS: Information requested by the Argentinean REC from other national RECs and ethics' experts was not useful to verify the adequacy of the REC's decision whether or not to approve the CT. The responses from the national regulatory agency and the sponsor were not helpful either. The identification of international resources that could assist was beyond the REC's capability. The information in the USA and other CT registries is limited, and at times misleading; and its accuracy is not verified by register keepers. DISCUSSION AND CONCLUSION: RECs have limited access to experts and institutions that could assist them in their deliberations. Sponsors do not always answer RECs' request for information to properly conduct the ethical and methodological assessment of CT protocols. The usefulness of the CT registries is curtailed by the lack of appropriate codes and by data errors. Information about reasons for rejection, withdrawal or suspension of the trial should be included in the registries. Establishing formal channels of communication among national and foreign RECs and with independent international reference centres could strengthen the ethical review of CT protocols.

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 goal of this study was to describe the prevalence and characteristics of unintended birth in this population. Using data from Hispanic participants in the Texas Pregnancy Risk Assessment Monitoring System 2009-2010, we studied unintended birth in relation to demographic, lifestyle and partner characteristics. Adjusted prevalence odds ratios (POR) were computed for each characteristic and the analysis was stratified by maternal nativity (US vs foreign born). The weighted proportion of unintended birth was 49.5 % (CI = 45.9-52.6). In adjusted analyses, women aged 12-19 had a higher prevalence of unintended birth compared to ≥20 years (POR = 2.1, CI = 1.3-3.7). Unmarried (POR = 1.5, CI = 1.1-2.1), uninsured (POR = 1.7, CI = 1.2-2.3), and US-born (POR = 1.6, CI = 1.0-2.6) women had higher prevalence compared to married, insured and foreign-born women, respectively. Among US-born Hispanic women, higher prevalence of unintended birth was associated with being young, unmarried and experiencing psychological stressors within 12 months of giving birth; among foreign-born Hispanic women, higher prevalence was associated with lack of insurance. Efforts to reduce unintended birth in Texas might focus on young, single, uninsured and US-born Hispanic women. Analyses of other pre-pregnancy factors and health outcomes among Texas Hispanics could increase understanding of the differences we observed in unintended birth between US and foreign-born Hispanics.

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. The cost of the most frequently-purchased medications was compared with pricing at pharmacies in El Paso, Texas, United States. RESULTS: Of the 311 medications purchased, the most frequent were: antibiotics (54), analgesics (49), fixed drug combinations (29), and blood pressure medications (26). Only 38% were purchased with a prescription; 62% of the prescription drugs bought without a prescription were self-prescribed. Many products purchased were of limited therapeutic value, and others could be harmful when used inappropriately. Pharmacy clerks were poorly trained and did not offer appropriate information on drug use; contraindications were never discussed. Contrary to popular perception, some generic drugs were cheaper in the United States than in Mexico. Conflicts of interest were identified that could be leading to over-medication. CONCLUSIONS: While the risks are evident, some uninsured, chronically-ill United States residents may benefit from access to medications previously recommended by a physician, without obtaining a new prescription. The authors suggest five steps for reducing the risks and improving pharmaceutical utilization in the border area.

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. We look at how the pandemic succeeded in mobilizing large quantities of government resources, and how citizens volunteered their bodies so that clinical trials could be completed quickly. However, patents prevented the expansion of manufacturing capacity, and the governments of a few wealthy countries prioritized the protection - and in some cases overprotection - of their citizens at the expense of protecting the rest of world's population. Among the major beneficiaries of the global response to the pandemic are the leading vaccine companies, their executives, and investors. The article concludes with some of the lessons learned in this process.

Este artículo resume las estrategias que se han utilizado para desarrollar rápidamente las vacunas COVID-19 y distribuirlas a nivel mundial. Se centra en las vacunas desarrolladas en los países occidentales. Con base en entrevistas y recopilación de información existente sobre la respuesta a la pandemia, tanto de agencias internacionales como de documentos oficiales de Brasil, Argentina, Colombia, Perú y México se reconoce que, si bien el desarrollo de las vacunas ha sido un éxito, su distribución a nivel mundial ha sido muy desigual. Como veremos, la pandemia consiguió movilizar una gran cantidad de recursos gubernamentales y los ciudadanos prestaron sus cuerpos para que los ensayos clínicos se pudieran concluir rápidamente. Sin embargo, las patentes impidieron la expansión de la capacidad de fabricación y los gobiernos de unos pocos países ricos priorizaron la protección y, en algunos casos, la sobreprotección de sus ciudadanos a expensas de la protección del resto de la población mundial. Entre los principales beneficiarios de la respuesta mundial a la pandemia se encuentran las principales empresas de vacunas, sus ejecutivos e inversores. El artículo concluye con algunas de las lecciones aprendidas en este proceso.

[Decentralization of health services: case studies in six Mexican states]. / Descentralización de los servicios de salud: estudios de caso en seis estados mexicanos.

OBJECTIVE: This article discusses the effects of the second decentralization of the Mexican Ministry of Health (1994-2000). MATERIAL AND METHODS: It is based on a review of official and archival documents, health and productivity statistics, observations in clinics and hospitals, and 232 in-depth interviews in the states of Baja California Sur, Colima, Guanajuato, Nuevo León, Sonora and Tamaulipas. The interviewees included high-level administrators of state and district health systems, leaders of workers unions, health providers and representatives of civil society. RESULTS: The article identifies the problems that offices of health at state level had to overcome to implement the decentralization. CONCLUSIONS: Descentralizacion failed to achieve the objectives stated by its promoters.

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. Here, we present a commentary on a systematic review by the scholars Morley-Hewitt and Owen titled 'A systematic review examining the association between female body image and the intention, initiation, and duration of postpartum infant feeding methods (breastfeeding vs. bottle-feeding)' that included nine peer-reviewed articles but missed at least eight other peer-reviewed articles that aligned with their study aim, and therefore introduced selection bias in the review. To complete the missing piece, we provide a short summary of these additional articles and describe how they align with this systematic review.

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

Introduction: 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. Methods: Data were derived from the Mexican National Health and Nutrition Survey (Encuesta Nacional de Salud y Nutrición [ENSANUT] 2012), and 10,466 women aged 20-49 years were included. Breastfeeding (<6 months versus ≥6 months) of the last child, BID (Stunkard Figure Rating Scale), anthropometric (body mass index, BMI), sociodemographics, and biological variables were collected. Crude and adjusted target associations and effect modifiers were assessed using weighted-logistic regression models. Results: Overall, 72.4% of ever breastfeeding mothers breastfed a minimum of 6 months, 22% were indigenous, 74% were dissatisfied with their body image (BID >0), and 37% had obesity (BMI ≥30 kg/m2). In the multivariable analysis, for each one-unit increase in the BID score, the adjusted odds of breastfeeding (≥6 months) decreased by 6% (odds ratio [OR] = 0.94, 95% confidence interval [CI]: 0.89-0.99). After stratifications, only among women with obesity, a greater BID score was associated with lower odds of breastfeeding duration by 24% (OR = 0.76, 95% CI: 0.64-0.89) in indigenous and by 10% (OR = 0.90, 95% CI: 0.82-0.98) in non-indigenous women. Conclusions: Mexican women with a higher BID score reported lower odds of breastfeeding duration (≥6 months). Body image concerns should be integrated into a health promotion curriculum to mitigate their negative effect particularly in certain segments of the populations, such as women with obesity and among indigenous women.

Desigualdad en el acceso a las vacunas: el fracaso de la respuesta mundial a la pandemia de COVID-19 / Inequity in access to vaccines: the failure of the global response to the COVID-19 pandemic

RESUMEN Este artículo resume las estrategias que se han utilizado para desarrollar rápidamente las vacunas COVID-19 y distribuirlas a nivel mundial. Se centra en las vacunas desarrolladas en los países occidentales. Con base en entrevistas y recopilación de información existente sobre la respuesta a la pandemia, tanto de agencias internacionales como de documentos oficiales de Brasil, Argentina, Colombia, Perú y México se reconoce que, si bien el desarrollo de las vacunas ha sido un éxito, su distribución a nivel mundial ha sido muy desigual. Como veremos, la pandemia consiguió movilizar una gran cantidad de recursos gubernamentales y los ciudadanos prestaron sus cuerpos para que los ensayos clínicos se pudieran concluir rápidamente. Sin embargo, las patentes impidieron la expansión de la capacidad de fabricación y los gobiernos de unos pocos países ricos priorizaron la protección y, en algunos casos, la sobreprotección de sus ciudadanos a expensas de la protección del resto de la población mundial. Entre los principales beneficiarios de la respuesta mundial a la pandemia se encuentran las principales empresas de vacunas, sus ejecutivos e inversores. El artículo concluye con algunas de las lecciones aprendidas en este proceso.

ABSTRACT 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. We look at how the pandemic succeeded in mobilizing large quantities of government resources, and how citizens volunteered their bodies so that clinical trials could be completed quickly. However, patents prevented the expansion of manufacturing capacity, and the governments of a few wealthy countries prioritized the protection - and in some cases overprotection - of their citizens at the expense of protecting the rest of world's population. Among the major beneficiaries of the global response to the pandemic are the leading vaccine companies, their executives, and investors. The article concludes with some of the lessons learned in this process.

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. Participants did not object to being interviewed and provided information not obtained during regular inspections. Participants were appreciative of the agency's concern for the integrity of the CT process. Most interviewees did not understand the consent form and were unaware that they were participating in an experiment with unapproved new drugs. Participants' decision to enroll in CT related to undue inducement and therapeutic misconception. Some patients' behaviors, undisclosed to researchers, could have compromised the integrity of the data collected.

Clinical trials in Latin America: implications for the sustainability and safety of pharmaceutical markets and the wellbeing of research subjects. / Ensayos clínicos en América Latina: implicancias para la sustentabilidad y seguridad de los mercados farmacéuticos y el bienestar de los sujetos.

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. In the study years, 33 medications were tested in 12 Latin American countries. Only 60% of the expected registrations had been completed by September 2014. With one exception, all products for which pricing information was obtained (n=18) cost more than one monthly minimum wage in all countries. Only five drugs were classified as "could be better than available treatments." Just one of the NMEs responds to the health care priorities in low and middle income countries.

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. This article summarizes the exchanges with WHO staff and posits the hypothesis that the WHO Bulletin might be affected by the shifts in WHO financing. Several authors have raised concern about the impact of financial conflicts of interest in WHO activities in the field of nutrition, intellectual property, and in the emergency response to the flu pandemic. Moreover, it has been reported that powerful WHO contributors pressured WHO into revising its publication policy. This is the first time that authors question if these conflicts of interest are also affecting the editorial independence of the WHO Bulletin.

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. DESIGN AND OBJECTIVES: Cross-sectional, descriptive study. To determine the therapeutic value and safety profile of the NMEs approved by the Food and Drug Administration (FDA) in 2011 and 2012 that had been tested in Latin America, and the implications of their market approval for the pharmaceutical budgets in the countries where tested. SETTING: Latin America. MEASURES: To assess the therapeutic value and safety of the NMEs commercialized in the different countries we used f independent drug bulletins. The prices of the NMEs for the consumers were obtained from the pharmaceutical price observatories of the countries were the medicines had been tested. If the price was not available in the observatories, it was obtained from pharmaceutical distributors. We used the countries' minimum wage and per capita income to calculate the financial accessibility of a course of treatment with the NMEs. RESULTS: We found that 33 NMEs approved by the FDA in 2011 and 2012 have been tested in Latin America. Of these, 26 had been evaluated by independent drug bulletins and only five were found to add some value to a subset of patients and had significant side-effects. The pharmaceutical prices were very high, varied widely across countries and were unrelated to the countries' income per capita or minimum wage. CONCLUSION: The implementation of clinical trials in Latin America results in the commercialization of medicines with questionable safety profiles and limited therapeutic value, putting patients at risk and causing budgetary strains in pharmaceutical budgets.