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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.

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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.

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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.

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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.

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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.

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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.

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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.

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Introducción: La responsabilidad por proteger a los seres humanos que participan en investigación ha sido delegada a los Comités de Ética de Investigación. La industria y los investigadores consideran que los CEI retrasan innecesariamente el inicio de la investigación y los bioeticistas dicen que no tienen los recursos para realizar sus funciones. El objetivo de este artículo es identificar las carencias y problemas que afectan el desempeño de los CEI que aprueban protocolos de ensayos clínicos financiados por la industria y las soluciones propuestas. Métodos: Revisión de la literatura que describe las características de los CEI ubicados en países de altos ingresos que revisan ensayos clínicos financiados por la industria, su desempeño y las sugerencias de fortalecimiento. Resultados: Los problemas que afectan el funcionamiento de los CEI se conocen desde finales del siglo pasado, tanto entidades reguladoras como investigadores han propuesto formas de fortalecerlos, pero solo unas pocas se han intentado y ninguna se ha institucionalizado. Llama la atención que todavía no haya estándares de formación mínima para los miembros de los CEI, ni se les haya dotado de recursos para monitorear adecuadamente la implementación de los ensayos. Conclusiones: La necesidad de profesionalizar los CEI beneficia a la industria. Los CEI, al revisar protocolos y monitorear la implementación de los ensayos clínicos y hablar con los sujetos, pueden detectar comportamientos que afectan la calidad de la información recabada y la seguridad de los voluntarios.

Introduction: The responsibility for protecting human beings involved in research has been delegated to the research ethics committees. The industry and the researchers consider that the CEI delay unnecessarily the initiation of the investigation and the Bioeticistas say that they do not have the resources to carry out their functions. The objective of this article is to identify the deficiencies and problems that affect the performance of the CEI that approve the protocols of clinical trials financed by the industry and the proposed solutions. Methods: Review of the literature describing the characteristics of CEI located in high-income countries reviewing industry-financed clinical trials, performance, and strengthening suggestions. Results: The problems affecting the functioning of the CEI have been known since the end of the last century, both regulatory entities and researchers have proposed ways to strengthen them, but only a few have been tried and none has been Institutionalized. It is striking that there are still no minimum training standards for CEI members, nor have they been provided with the resources to adequately monitor the implementation of the trials. Conclusions: the need to professionalize the CEI benefits the industry. CEI, by reviewing protocols and monitoring the implementation of clinical trials and speaking with subjects, can detect behaviors that affect the quality of information collected and the safety of volunteers.

Introdução: A responsabilidade de proteger os seres humanos que participam da pesquisa foi delegada aos Comitês de Ética em Pesquisa. A indústria e os pesquisadores acreditam que as CEI atrasam desnecessariamente o início da investigação e os bioeticistas dizem que não dispõem dos recursos para desempenhar suas funções. O objetivo deste artigo é identificar as deficiências e os problemas que afetam o desempenho das CEI que aprovam protocolos de ensaios clínicos financiados pela indústria e as soluções propostas. Métodos: Revisão da literatura que descreve as características dos CEI localizados em países de alta renda que analisam ensaios clínicos financiados pela indústria, seu desempenho e sugestões de fortalecimento. Resultados: Os problemas que afetam o funcionamento das CEI são conhecidos desde o final do século passado, ambas entidades reguladoras e pesquisadores propuseram formas de fortalecêlas, mas apenas algumas foram julgadas e nenhuma foi institucionalizada. É surpreendente que ainda não existam padrões mínimos de treinamento para os membros dos CEI, nem foram fornecidos recursos para monitorar adequadamente a implementação dos testes. Conclusões: A necessidade de profissionalizar os CEI beneficia o setor. Os CEI, ao revisar protocolos e monitorar a implementação de ensaios clínicos e conversar com os sujeitos, podem detectar comportamentos que afetam a qualidade das informações coletadas e a segurança dos voluntários.

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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.

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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.

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Abstract Pharmaceutical companies affect prescribing behavior through various means, including pharmaceutical salespeople (drug reps), drug samples, influential peers, and educational events. Information on drugs provided by industry representatives has been shown to be inaccurate. Drug samples are among the most effective marketing tools that companies have. "Thought leaders" or "key opinion leaders" are used to persuade peers to use drugs for unapproved uses, raise awareness of targeted diseases, and to shape perceptions of a drug's benefits and harms, as well as perceptions about competing drugs. Although grants provided for talks, seminars, and meetings are described as "unrestricted," it is understood that the company gets to select some speakers, and that speakers with views that undermine marketing messages will not be invited. Promotion has been shown to increase physicians' prescription of targeted drugs, and increases prescription costs.

Resumen Las empresas farmacéuticas influyen sobre la conducta para formular los medicamentos de diversas formas, incluyendo a los vendedores de las empresas farmacéuticas (representantes de medicamentos), las muestras de medicamentos, pares influyentes y eventos educativos. La información sobre los medicamentos suministrada por los representantes de la industria ha demostrado ser inexacta. Las muestras de medicamentos son una de las herramientas de mercadeo más efectivas con que cuentan las empresas. Se recurre a "Los líderes de pensamiento" o a los "principales líderes de opinión" (KOLs por sus siglas en inglés) para convencer a sus pares de que utilicen medicamentos para usos no aprobados, sensibilizar sobre patologías objetivo, y conformar percepciones sobre los beneficios y perjuicios de un medicamento, además de crear impresiones sobre medicamentos en competencia. A pesar de que se dice que las asignaciones monetarias para dictar charlas, celebrar seminarios y reuniones no deben tener restricciones, es claro que la empresa selecciona determinados conferencistas y que aquellos cuyas opiniones socaven los mensajes de mercadeo no serán invitados. Se ha demostrado que la promoción aumenta la prescripción de medicamentos específicos y aumenta los costos de esta.

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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.

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RESUMEN Este estudio buscó verificar si los medicamentos aprobados por la Food and Drug Administration (FDA) de EE.UU. fueron registrados, comercializados y vendidos a precios accesibles en los países latinoamericanos en los que fueron testeados, además de constatar su contribución a la calidad del mercado farmacéutico. Se consultó la lista de nuevas entidades moleculares (NEM) aprobadas por la FDA en 2011 y 2012 para identificar los países en los cuales se realizaron ensayos pivotales. Se analizó la accesibilidad económica como proporción de ingresos y se recolectó información sobre seguridad y eficacia en boletines independientes de medicamentos. En los dos años analizados, se testearon 33 medicamentos en 12 países latinoamericanos. Solo el 60% de los registros esperados se habían completado para septiembre de 2014. A excepción de uno, todos los productos para los cuales se obtuvo información de precio (n=18) costaron más que un sueldo mínimo mensual en todos los países. Solo cinco medicamentos fueron clasificados como "posiblemente mejores que otros tratamientos disponibles". Solo una de las NEM satisface las prioridades de la atención médica de los países de bajos y medianos ingresos.

ABSTRACT 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.

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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.

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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.

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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.

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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.

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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.

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