Salud y Fármacos is an international non-profit organization that promotes access and the appropriate use of pharmaceuticals among the Spanish-speaking population.
Salud y Fármacos is an international non-profit organization that promotes access and the appropriate use of pharmaceuticals among the Spanish-speaking population.
2016 – Present
In November 2016, there was a meeting at the Universidad del Bosque (Colombia) involving participants from Argentina, Brazil, Chile, Colombia, Mexico, Panama, Peru, and Dominican Republic. The aim of the meeting was to revise and agree on the aims and methods of a new study entitled “In search of strategies to strengthen the Latin American research ethics committees that review clinical trials financed by industry.”
In May 2018, we had a second meeting to discuss the preliminary findings from each participating and to plan the remaining tasks. We anticipate publishing the final results by the end of 2021.
Although we are in the process of analyzing the resutls, we have presented partial results at several conferences organized by the El Bosque University (Bogota, Colombia), Antioquia University (Medellín, Colombia), Free University of Pereira (Colombia), Autonomous University of Bucaramanga (Colombia), and the University of Buenos Aires (Argentina). We have also published the following articles and book chapters:
N Homedes and A Ugalde. Los Comités de Ética en Investigación y la Protección de los Participantes en Ensayos Clínicos. Research Ethics Committees and the Protection of Human Subjects in Clinical Trials. Revista Colombiana de Bioética 2019; 14(1):146-160
A Ugalde and N Homedes. Los Comités de Ética en Investigación en América Latina ¿Para qué sirven? Research Ethics Committees in Latin America: What do they accomplish? Revista Colombiana de Bioética 2019; 14(1):111-127
Homedes N, Ugalde A. Outsourcing Clinical Trials to Latin America: causes and impact. In Rivera López E and Hevia (Editors). Controversies in Latin American Bioethics. The Netherlands: Springer. 2019 Pp 115-144
N Homedes and A Ugalde. La prescripción médica y la ética: de la teoría a la práctica [Ethics and the medical prescription: from theory to practice]. En Duque Zea, JH (Editor). Controversias en Bioética clínica. Capítulo 10. Corporación para Investigaciones Biológicas CIB COL/MEX/PAN 2020.
N Homedes, Fernando Hellman, Duilio Fuentes, Eduardo Hernandez Ybarra, Antonio Ugalde. Problemas éticos nos ensaios clínicos financiados pela indústria farmacêutica na América Latina. In Faintuch (Editor), Manole Brazil)
2014 and 2015
In 2014, Salud Colectiva (Argentina) asked us to coordinate an issue of their journal devoted to pharmaceuticals that was published at the beginning of 2015.
During the same year, the Agency responsible for the regulation of clinical trials in Perú, OGITT, requested training in qualitative research methods. Specifically, they wanted to incorporate in-depth interviews with clinical trial participants as part of the ordinary site inspections. The results have been published in Minaya G, Fuentes D, Ugalde A, Homedes N. A missing piece in clinical trial inspections in Latin America: interviews with research subjects in Peru. Journal of Empirical Research on Human Research Ethics; 12(4) 232–245
2013
In 2013, while reviewing the literature, Salud y Fármacos discovered that The Lancet had published erroneous information on the results of legal suit against GSK for the inappropriate management of a clinical trial in Argentina. Salud y Fármacos decided to write an article correcting the information entitled “The contribution of high-impact clinical journals to science: the case of The Lancet”, that was published by Salud Colectiva in August 2013 and can be found in http://www.scielo.org.ar/scielo.php?pid=S1851-82652013000100001&script=sci_arttext
2011
In August 2011 we were asked to write a lead article for a debate on Clinical Trials by Salud Colectiva. The debate can be accessed in Spanish at http://revistas.unla.edu.ar/saludcolectiva/article/view/369
2010
A second workshop on Clinical Trials and Ethics was held in Buenos Aires in August 2010. The workshop was attended by 23 participants from Argentina, Brazil, Costa Rica, México and Peru. After reviewing the progress made since our previous meeting, workshop participants discussed strategies to advance in three areas: (a) the regulatory framework for clinical trials; (b) the establishment of Clinical Trial Observatories; and (c) strategies to analyze the performance of Research Ethics Committees and develop strategies to strengthen the ethical review of research protocols.
On September 30th, we submitted comments to a draft of European Clinical Trials Regulations. The critique was later presented at the conference organized by EMA: Critique to the Draft Reflection Paper on Ethical and GCP Aspects of Clinical Trials and Medicinal Products for Human Use Conducted in Third Countries and Submitted in Marketing Authorization Applications to the European Medicines Agency (EMA). EMA: London, 6-7 September.
2009
In October 2009, representatives from WEMOS and Salud y Fármacos, interested faculty of the University of Costa Rica and professionals of the Caja Costarricense de Seguro Social met at the University of Costa Rica to discuss the possibility of establishing a Clinical Trial Observatory for Central America. The group used this opportunity to develop a protocol for a multicentric study of CROs, to include Brazil, Argentina, and Peru. WEMOS, SOMO (Holland) and Salud y Fármacos signed a contract to finance the study based on the protocol developed during this meeting. The final report of the study, incorporating data collected by the Bombay Centre for Studies in Ethics and Rights is available here http://somo.nl/publications-en/Publication_3615
2008
In May 2008, with the financial support of the WEMOS Foundation, a Dutch Foundation, the Pan-American Health Organization – Argentina, Salud y Fármacos organized the first workshop on ethics and pharmaceuticals in Buenos Aires, Argentina. Twenty-five specialists from Argentina, Brazil, Costa Rica, Mexico, Peru, and the U.S.A. participated in the meeting, including representatives from three regulatory agencies (ANMAT-Argentina, ANVISA-Brazil, and DIGEMID-Peru). A research plan on ethics, clinical trials, and human rights was developed, and the Buenos Aires Declaration on Clinical Trials was approved. The research plan included the development of multicenter studies on research ethics committees, informed consent, and Contract Research organizations (CROs), as well as the organization of Clinical Trials Observatories.
In November 2008, following the objectives set at the meeting in Buenos Aires, four members of RELEM met with the director of FioCruz-Brasilia and a group of Brazilian researchers to discuss the possibility of establishing a Clinical Trial Monitoring site in Brazil.
2007
In 2007 Salud y Fármacos conducted an on-line survey in several Latin American countries to obtain information on ethical violations around the pharmaceutical cycle (research and development of new products, production, distribution, regulation, marketing, prescribing, dispensing, utilization and disposal of medicines). Many people responded, and, in view of this interest, we invited them to form a network: The Latin American Network of Ethics and Pharmaceuticals (RELEM). The result of the survey was presented in the name of (RELEM) at the conference on Pharmaceutical Policy Analysis at Zeist (Holland, September 19-21, 2007) with the title “Clinical Trials and Ethics in Latin America”.
