Activities

2007. Salud y Farmacos 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”.

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.

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

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; (2) 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.

In August 2011 we were asked to write a lead article for a debate on Clinical Trials by Salud Colectiva (Argentina). The debate can be accessed in Spanish at http://www.unla.edu.ar/public/saludColectivaNuevo/publicacion20/index.php

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

In 2014, Salud Colectiva 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.

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 2019.

Publications

Huijstee M van, Shipper I (editors). Authors in alphabetical order: Balbinot RAA, Bhagianadh D, Freitas CBD, Fuentes Delgado DJ, Dallari SG, Homedes N, Huijstee M van, Martich E, Minaya Martínez GM, Schipper I, Ugalde A. Putting Contract Research Organizations on the Radar. SOMO, Salud y Fármacos, Center for Studies in Ethics and Rights: Amsterdam. February 2011. http://somo.nl/publications-en/Publication_3615

Núria y Antonio Ugalde, eds. Las farmacias, los farmacéuticos y el uso adecuado de medicamentos en América Latina. Editorial Lugar, Bs.As. 2011

Salud Colectiva, August 2011, published a clinical trials debate. SyF wrote the main article and RELEM members contributed comments to the article. It is available at: http://www.unla.edu.ar/public/saludColectivaNuevo/publicacion20/index.php

Critique to WHO document entitled: Standards and Operational Guidance for Ethics Review of Health-Related Research in Human Participants. February 2011.

Contract Research Organizations in Argentina, Brazil, Costa Rica, Mexico and Peru. For WEMOS y SOMO, 50 pages.

Núria Homedes, Antonio Ugalde. Ensayos Clínicos y Ética en América Latina. Editorial Lugar (Argentina): Buenos Aires. 2012. All chapters written by members of RELEM.

Mariette Van Huijstee, Homedes N. Putting Contract Research Organizations on the radar. International Psychiatry, 2012; 9(2): 32-33.

Garrafa V, Homedes N, Ugalde A. Comments to article “Ética e Investigación”. Rev Peru Med Exp Salud Pública, 21012; 29 (1): 149.

Olave Quispe S, Fuentes Delgado D, Minaya Martínez G, Surco Ibarra R, Yagui Moscoso M, Espinoza Silva, Senent de Frutos JA, Homedes N. The development and validation of a guide for Peruvian research ethics committees to assist in the review of ethical-scientific aspects of clinical Trials. In, Jan Schildmann, Verena Sandow, Oliver Rauprich y Jochen Vollmann (Editores). Human Medical Research, Ethical, Legal and Socio-Cultural Aspects. Springer, 2012, Págs 97-116.

Homedes N, Ugalde A. La globalización de los ensayos clínicos, los derechos humanos, y el respeto a los principios éticos en América Latina. In Porto D, Garrafa V, Martins GF et al (Eds). Bioéticas, Poderes e Injusticas: 10 anos depois. Brasilia. Conselho Federal de Medicina, Cátedra Unesco de Bioética, Sociedade Brasileira de Bioética. 2012: 247-264. http://portal.cfm.org.br/images/stories/biblioteca/bioeticaspoderesinjusticas.pdf

Núria Homedes, Antonio Ugalde. Mexican pharmacies: benefits and risks for border residents in the United States of America and Mexico. Pan American Journal of Public Health 2013; 33(3):196-204. http://tinyurl.com/klzsa8b

Antonio Ugalde, Núria Homedes. La contribución de las revistas clínicas de alto impacto a la ciencia: El caso de The Lancet. Salud Colectiva 2013; 9(1):5-10. With Nuria Homedes with comments from other RELEM members (Ricardo Martínez, V. Garrafa, et al.) http://tinyurl.com/kdjhml4

Comments to changes in the Clinical Trial Regulations of Peru. 2013.

Homedes N, Ugalde A (Editors). Clinical Trials in Latin America: Where Ethics and Business Clash. The Netherlands: Springer 2014. All chapters written by members of RELEM.

Homedes N, Ugalde A. Problemas Éticos de los Ensayos Clínicos en América Latina. Revista Red Bioética Unesco 2014; 5, 2 (10): 51-63. http://www.unesco.org.uy/shs/red-bioetica/fileadmin/shs/redbioetica/Revista_10/Art5-Homedes-R10.pdf

Homedes N, Ugalde A. Seeking help to confirm a decision: A case study of an Argentinean research ethics committee. Journal of Medical Ethics. Published on-line, 23 of October 2014. http://jme.bmj.com/content/early/2014/10/23/medethics-2013-101381.short?g=w_jme_ahead_tab

Ugalde A, Homedes N. La contribución de los investigadores/administradores fieles a la industria en la ética y calidad de los ensayos clínicos en América Latina. Salud Colectiva, 2015; 11(1): 67-86 http://revistas.unla.edu.ar/saludcolectiva/article/view/416

Homedes N, Ugalde A. El medicamento y los actores involucrados en su uso apropiado. Salud Colectiva, 2015; 11(1): 5-8. http://revistas.unla.edu.ar/saludcolectiva/article/view/411/427

Homedes N, Ugalde A. Availability and affordability of new medicines in Latin American countries where pivotal clinical trials were conducted. WHO Bulletin 2015; 93 (10): 674-683. doi: http://dx.doi.org/10.2471/BLT.14.151290

Homedes N, Ugalde A. Are Private Interests Clouding the Peer-review Process of the WHO Bulletin? A Case Study. Accountability in Research. Policies and Quality Assurance, 2016 10.1080/08989621.2016.1171150.

Homedes N, Ugalde A. Health and Ethical Consequences of Outsourcing Pivotal Clinical Trials to Latin America: A Cross-Sectional, Descriptive Study. PLoS ONE 2016; 11(6): e0157756. doi:10.1371/journal.pone.0157756 http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0157756

Homedes N, Ugalde A. Clinical trials in Latin America: implications for the sustainability and safety of pharmaceutical markets and the wellbeing of research subjects. Salud Colectiva 2016; 12(3). http://revistas.unla.edu.ar/saludcolectiva/article/view/1073/1040\

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; 2017; 12(4) 232–245.

Homedes N, Ugalde A. Latin American research ethics committees: Whose interest do they serve? In European Congress of Research Ethics Committees. EUREC-ANCEI Joint Conference. Book of presentations and communications, 2017: Pp 75-82.

Fugh-Berman A, Homedes N. How drug companies manipulate prescribing behavior. Revista Colombiana de Anestesiologia 2018;46(4):317-321.

Presentations:

FDA: Clinical Research Integrity in Latin America. In FDA, US International Working Group. April 13, 2011.

Ministerio de Salud de Guatemala: Comités de Ética de Investigación en América Latina y Consideraciones para los Biobancos, May 13, 2011.

IX Brazilian Congress on Biethics: Clinical trials: business or science. Brasilia, September 7-10, 2011.

Georgetown University. The Globalization of Clinical Trials: ethical and human rights consequences. October 14, 2011.

Consortium of Universities for Global Health. Clinical trials: business or science. Montreal (Canada), November 13-15, 2011.

Globalization and Clinical Trials: Ethical and Human Rights Consequences. Boston: Northeastern University. June 11, 2012.

Post-trial Access to treatment. SOMO. Rotterdam: June, 26-27, 2012.

Los Comités de Ética en Investigación. Universidad de Nayarit. Tepic, México, August 18, 2012.

Fraude Científico y terapia clínica. Tercer curso de Políticas de Salud Pública. Ministerio de Salud Pública de El Salvador, December 1, 2013 (Via IATV).

La globalización de los ensayos clínicos: las consecuencias para América Latina. Primer Congreso Iberoamericano de Ética de Investigación. El Salvador, San Salvador, February 25, 2013.

Los comités de ética de investigación en América Latina: su situación y la necesidad de trabajar en red. Research Ethics Committees in Latin America: situation and need to network. Primer Congreso Iberoamericano de Ética de Investigación. El Salvador, San Salvador, February 26, 2013.

Fraude científico en la investigación multinacional y su impacto en la práctica clínica (Scientific fraud in multinational research and its impact in clinical practice). Reunión Internacional de Bioética y medicamentos. Fundación del Hospital San Vicente, Medellín (Colombia),August 29; and X Congreso Brasileiro de Bioética, Florianopolis (Brazil), September 27, 2013.

Ética y globalización de la industria farmacéutica: impacto en los ensayos clínicos (Globalization of the pharmaceutical industry and ethics: impact on clinical trials). Fundación del Hospital San Vicente, Medellín (Colombia), August 29; and X Congreso Brasileiro de Bioética, Florianopolis (Brazil), September 27, 2013.

El derecho a la salud y las reformas neoliberales de salud. 8va Conferencia Internacional de Salud Pública, Justicia Social, Derechos Humanos y Equidad. Medellin (Colombia), November 27-29, 2013.

The commercialization of pharmaceuticals. Georgetown University. International Health Department. February 23, 2015.

Ethical Issues in clinical research. Georgetown University. International Health Department. March 31, 2015.

Issues in debate: the use of placebo and standards of care. In Research Ethics Workshop. Organized by UNESCO and CARPHA (Caribbean Public Health Agency), Antigua October 6-9, 2015.

“Developing procedures for the ethical review of clinical trials. In Research Ethics Workshop. Organized by UNESCO and CARPHA (Caribbean Public Health Agency), Antigua October 6-9, 2015.

Standards of Ethical Review: the evaluation of value and scientific validity. In Research Ethics Workshop. Organized by UNESCO and CARPHA (Caribbean Public Health Agency), Antigua October 6-9, 2015.

Unethical practices of the pharmaceutical industry and their impact on prescribers. Health Policy Course organized by the Ministry of Health. San Salvador, El Salvador. November 26, 2015

Comportamientos no éticos de la industria farmacéutica y su impacto en los prescriptores. Curso de Políticas de Salud, Ministerio de Salud. San Salvador, El Salvador, April 24, 2016, and December 2, 2016.

Consequences of the implementation of pivotal clinical trials on the Latin American pharmaceutical markets. (Las consecuencias de implementar ensayos clínicos pivotales para los mercados farmacéuticos Latinoamericanos). Meeting on Pharmaceutical research: characteristics and context. Universidad del Bosque, Bogota (Colombia). June 24, 2016. Public Citizen, Washington, DC, Deciembre 7, 2016.

Implicancias de hacer ensayos clínicos en América Latina. Colciencias (Bogotá, Colombia), October 28 -29, 2016.

Latin American research ethics committees: Whose interest do they serve? In European Congress of Research Ethics Committees. EUREC-ANCEI Joint Conference. Barcelona, May 17-19, 2017.

Del dicho al hecho: Taming Big PhRMA in Latin America Taming Pharmakon. Conference organized by the University of Notre Dame. Roma, October 12-14, 2017.

Comportamientos no éticos de la industria farmacéutica y su impacto en los prescriptores. Curso de Políticas de Salud, Ministerio de Salud. San Salvador, El Salvador. November 30, 2017 (via webex).

La industria farmacéutica y su impacto en el comportamiento del profesional médico. Programa de Maestria en Salud Pública, Universidad de Nayarit, Tepic. April 25, 2018.

Los Comités de Ética en Investigación y la Protección de los Sujetos que Participan en Ensayos Clínicos. En, XXIV Seminario Internacional en Bioética. Tecnocracia or Democracia. Universidad del Bosque, Bogotá, August 17- 18, 2018.

Los Comités de Ética en Investigación ¿Para qué sirven? En, XXIV Seminario Internacional en Bioética. Tecnocracia o Democracia. Universidad del Bosque, Bogotá, August 17- 18, 2018.

Ensayos Clínicos y Ética en América Latina. In State of the Art in National Autonomous University of Bucaramanga (Internal Medicine) and La Focal (Bucaramanga, Colombia), October 26, 2018