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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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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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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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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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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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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. Doing so increases the period in which they can sell drugs at monopoly prices. We therefore discuss how innovative pharmaceutical firms shorten the implementation time of clinical trials in Latin America and the consequences such actions have on the quality of the collected data, the protection of human rights of the subjects of experimentation, and compliance with the ethical principles approved in international declarations.

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Este artículo explica las dificultades que tienen las farmacéuticas innovadoras para retribuir a sus accionistas con dividendos atractivos. El problema es el resultado de la caducidad de las patentes de los medicamentos estrella (blockbusters) y las dificultades que tienen en desarrollar nuevos medicamentos estrella. Una solución que las empresas han encontrado es acelerar la ejecución de los ensayos clínicos para obtener, en el menor tiempo posible, el permiso de comercialización y así incrementar el tiempo monopólico de ventas de los nuevos medicamentos. En este contexto, los autores describen la forma en que las farmacéuticas innovadoras acortan el tiempo de ejecución de los ensayos en América Latina y las consecuencias en la calidad de los datos que se obtienen, en la protección de los derechos humanos de los sujetos de experimentación, y en el cumplimiento de los principios éticos aprobados en las declaraciones universales.

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. Doing so increases the period in which they can sell drugs at monopoly prices. We therefore discuss how innovative pharmaceutical firms shorten the implementation time of clinical trials in Latin America and the consequences such actions have on the quality of the collected data, the protection of human rights of the subjects of experimentation, and compliance with the ethical principles approved in international declarations.

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Este artículo explica las dificultades que tienen las farmacéuticas innovadoras para retribuir a sus accionistas con dividendos atractivos. El problema es el resultado de la caducidad de las patentes de los medicamentos estrella (blockbusters) y las dificultades que tienen en desarrollar nuevos medicamentos estrella. Una solución que las empresas han encontrado es acelerar la ejecución de los ensayos clínicos para obtener, en el menor tiempo posible, el permiso de comercialización y así incrementar el tiempo monopólico de ventas de los nuevos medicamentos. En este contexto, los autores describen la forma en que las farmacéuticas innovadoras acortan el tiempo de ejecución de los ensayos en América Latina y las consecuencias en la calidad de los datos que se obtienen, en la protección de los derechos humanos de los sujetos de experimentación, y en el cumplimiento de los principios éticos aprobados en las declaraciones universales.(AU)

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. Doing so increases the period in which they can sell drugs at monopoly prices. We therefore discuss how innovative pharmaceutical firms shorten the implementation time of clinical trials in Latin America and the consequences such actions have on the quality of the collected data, the protection of human rights of the subjects of experimentation, and compliance with the ethical principles approved in international declarations.(AU)

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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.

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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.

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