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.
Agencias reguladoras y registro de medicamentos
Chan AW. Bias, spin and misreporting:time for full access to trial protocols and results. PLoS Medicine 2008; 5(11):e230 http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0050230
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Food and Drug Administration Amendments Act (FDAAA) of 2007. Disponible en http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/default.htm
Giezen TJ, Mantel-Teewisse M, Straus SMJM, Egberts TCG, Blackburn S, Persson I, Leufkens HGM. Evaluation of post-authorization safety-issues in the first cohort of EU risk management plans at time of regulatory approval. Drug Safety 2009; 32:1175-87
Lewis JA. The European regulatory experience. Statistics in Medicine 2002; 21:2931-2938
Prescrire. Obligaciones legales para la transparencia en la Agencia Europea del Medicamento: Evaluación de Prescrire durante cuatro años. Rev Prescrire, julio de 2009; 29 (309): 534-540 Traducido por Boletín Fármacos y disponible en castellano en Boletín Fármacos 2010; 13(1), Sección Regulación y Políticas
Schipper I, Weyzig F. Ethics for drug testing in low and middle income countries. Considerations for European market authorization. The Netherlands: SOMO. Febrero 2008. También disponible en español http://www.somo.nl/html/paginas/pdf/Ethics_for_Drug_Testing_feb08_EN.pdf
Schnitzbauer A, Lamby PE, Mutzbauer I, Zuelke C, Schlitt HJ, Geissler EK. Europe gets nut points for harmony in trials. BMJ 2009; 338:1302-4
Schwartz LM, Woloshin S. Lost in transmission – FDA drug information that never reaches clinicians. New England Journal of Medicine, 2009;361(18):1717-1720 Resumido en castellano en Boletín Fármacos 2009 12(5) Comunicación en la sección de Regulación y Políticas.
Van Lujin JCF, Gribnau FWJ, Leufkens HGM. Availability of comparative trials for the assessment of new medicines in the European Union at the moment of market authorization. British Journal of Clinical Pharmacology 2006;63(2): 159-162 Resumen disponible en http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2000577
WEMOS. Do European registration authorities ascertain whether clinical trials in developing countries have been conducted in an ethical manner? Junio 2007. http://wemos2004.ddg22.tamtam.nl/Documents/summary_english.pdf
Diseminación de resultados
Ghersi D, Clarke M, Berlin J et al. Reporting of clinical trials: a discussion paper. WHO Bulletin 2008; 86(6) http://www.who.int/bulletin/volumes/86/6/08-053769/en/print.html
Krleza-Jeric K, Djubegovic B, Nasser M, Reveiz L, Huic M, Lemmens T, Sim I, Armstrong W, Metz C, Elemam K, Wager E. International standards for Public Reporting of Clinical Trial Outcomes and Results (PROCTOR): a proposal to increase the quality of evidence produced by systematic reviews. Cochrane Colloquium Singapur, October 2009
Lee K, Bacchetti P, Sim I. Publication of clinical trials supporting successful new drug applications: A Literature Analysis. PLoS Medicine 2008; 5(9):e191
PLoS Medicine Editors. Next stop, don’t block the doors: opening up access to clinical trial results. PLoS Medicine 2008; 5(7): e160.doi:10.1371/journal.pmed.0050160 http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0050160
Rising K, Baccheti P. Bero L. Reporting bias in drug trials submitted to the Food and Drug Administration:review of publication and presentation. PloS 2008; 5(11): e217 http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0050217 Correction: http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371%2Fjournal.pmed.1000017
Registro de medicamentos en los países donde se realizan los ensayos
Sanciones
Gumbel A. Drug giant faces criminal charges over clinical trials. The Independent 31 mayo 2007 http://www.independent.co.uk/news/world/americas/drugs-giant-faces-criminal-charges-over-clinical-trial-451092.html
Harris G, Roberts J. After sanctions, doctors get drug company pay. New York Times 3 de junio 2007. http://www.nytimes.com/2007/06/03/health/03docs.html
Smith J, Goldee F. Investigating allegations of scientific misconduct. BMJ 2005;331:245-246 http://www.bmj.com/cgi/reprint/331/7511/245?ijkey=83898e35b73ff2f48d96e60d0b626d585aad9a9e
Young C, Goldee F. Managing suspected research misconduct. BMJ 2007;334:378-379 http://www.bmj.com/cgi/content/full/334/7590/378?ck=nck
Violaciones éticas en la realización de ensayos clínicos
(Ver la sección de revistas y periodicos, la seccion por paises, y la seccion de ética en el Boletín Fármacos www.saludyfaramcos.org
Amnesty International. A Bitter Pill. Ammesty International Magazine, Verano de 2003.
Argetsinger A. Panel blames Hopkins in research death. The Washington Post, August 30, 2001 B03
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BBC. Secrets of the drug trials. http://news.bbc.co.uk/2/hi/programmes/panorama/6291773.stm
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Concar D. A Bitter Pill. Exporting drug trials to the developing world. Ammnesty International Magazine. Summer 2003 http://www.amnestyusa.org/amnesty-magazine/summer-2003/a-bitter-pill-exporting-drug-trials-to-the-developing-world/page.do?id=1105438
El Clarín (Buenos Aires). Un informe sobre ética en las investigaciones con pacientes oncológicos de la defensoría del pueblo de la nación de Argentina denuncia que el estado no controla pruebas de drogas en pacientes con cáncer, 22 de mayo 2002. Puede acceder a Boletín Fármacos 2003; 6(3): 146.
Ensayos clínicos inseguros. Diario La República. Sociedad del 15 de mayo del 2007 En: http://www.larepublica.com.pe/component/option,com_anteriores/Itemid,589/?palabras=Ensayos+cl%EDnicos&palabras_parte=0&seccion=0&por_rango=1&rango=-1&dia_ini=1&mes_ini=2&a_ini=2007&dia_fin=31&mes_fin=5&a_fin=2007&Submit=Buscar&accion=buscar&option=com_anteriores (acceso marzo 2010)
Evans D, Smith M, Willen L. Drug industry human testing masks death, injury, compliant FDA. Bloomberg Report, November 2, 2005 http://quote.bloomberg.com/apps/news?pid=10000006&sid=aspHJ_sFen1s&refer=home#
Federico M. Se investiga si 12 bebes murieron por un experimento. Critica de Argentina, 10 de julio de 2008. Disponible en Boletín Fármacos 2008; (4) Sección ed Etica y Derecho
Freking K. NIH finds ethics violations in 44 cases. Long Island, NY Newsday July 15, 2005 http://www.commondreams.org/headlines05/0715-01.htm
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Lerner B. Sins of omission: cancer resarch without informed consent. NEJM 2004; 351(7):628-630
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Menos control en experimentos con seres humanos. Diario Perú 21 del 03 de febrero del 2007. En: http://peru21.pe/impresa. (acceso marzo 2010)
Orchuela J. Denuncias por investigación de medicamentos sin consentimiento en hospital neuropsiquíatrico de mujeres. Boletín Fármacos 2006; 9(2): 126-129
Orchuela J. Investigaciones clínicas con medicamentos y vacunas en hospitales públicos de Córdoba y Santiago de Estero fuertemente cuestionadas. Boletín Fármacos 2006b; 9(1):100-105. www.boletinfarmacos.org
Petinelli A. Irregularidades en proyecto epidemiológico. Boletín Fármacos 2007; 10(4):107-110.
Rockwell DH, Yobs AR, Moore MB Jr. The Tuskegee study of untreated syphilis; the 30th year of observation. Arch Intern Med. 1964;114:792-8.
Saad Hossne W, Vieira S. Fraude em Ciencia:onde estamos? Revista Bioética 2007; 15(1):39-47
SOMO. Briefing paper on ethics and clinical trials. #1; Examples of unethical trials. November 2006. También disponible en español http://somo.nl/html/paginas/pdf/Examples_of_unethical_trials_nov_2006_NL.pdf
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Tribunal Internacional de Nüremberg. Código de Nuremberg. 1946. www.pcb.ub.es/bioeticaidret/archivos/norm/CodigoNuremberg.pdf. Acceso Octubre 30 de 2009
Wainfeld M. Un laboratorio extranjero testeó una droga en un hospital del PAMI sin permiso y pagando en negro. Cobayos de tercera edad para una prueba ilegal. Pagina/12 26 de marzo, 2007 http://www.pagina12.com.ar/diario/elpais/1-82337-2007-03-26.html
Williyard C. Pfizer lawsuit spotlights ethics of developing clinical trials. Nature Medicine 2007; 13(7):763
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