[1] Recomiendo el texto clásico para estudiantes de medicina «Rang and Dale», Rang & Dale’s Pharmacology, 6.ª ed., Churchill Livingstone, 2007. Pero, sobre el proceso regulador en torno al desarrollo de fármacos, véase también: Friedhoff, L. T., New Drugs: An Insider’s Guide to the FDA’s New Drug Approval Process for Scientists, Investors and Patients, PSPG Publishing, 2009. <<
[2] Elliott, C., Abadie, R., «Exploiting a research underclass in phase 1 clinical trials», New England Journal of Medicine, vol. 358, n.° 22, 2008, pág. 2316. <<
[3] Cohen, L. P., «To screen new drugs for safety, Lilly pays homeless alcoholics: it’s “quick cash” to habitues of Indianapolis shelters; it vanishes quickly, too», Wall Street Journal (East Ed), 14 de noviembre de 1996, A1, A10. <<
[4] Abadie, R., The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects, Duke University Press, 2010. <<
[5] Helms, R. (comp.), Guinea Pig Zero: An Anthology of the Journal for Human Research Subjects, Garrett County Press, 2006. <<
[6] Tucker, T., Great Starvation Experiment: Ancel Keys and the Men Who Starved for Science, Universisty of Minnesota Press, University of Minnesota Press Ed., 2008. <<
[7] Gorkin, L., Schron, E. B., Handshaw, K., Shea, S., Kinney, M. R., Branyon, M. y otros, «Clinical trial enrollers vs. nonenrollers: The Cardiac Arrhytmia Suppression Trial (CAST). Recruitment and Enrollment Assessment in Clinical Trials (REACT) project», Controlled Clinical Trials, vol. 17, n.° 1, febrero de 1999, págs. 46-59. <<
[8] Sheppard, V. B., Cox, L. S., Kanamori, MJ., Cañar, J., Rodriguez, Y., Goodman, M. y otros, «BRIEF REPORT: If you Build It, They Will Come», Journal of General Internal Medicine, vol. 20, n.° 5, mayo de 2005, págs. 444-447. <<
[9] «CRO Market» - ACRO [Internet] [citado el 11 de febrero de 2012]. Disponible en http://www.acrohealth.org/cro-market1.html. <<
[10] MacDonald, T., Hawkey, C., Ford, I., «Time to treat as independent», British Medical Journal, vol. 341, 30 de noviembre de 2011, c6837. <<
[11] Kassirer, J., On the Take: How Medicine’s Complicity with Big Business Can Endager Your Health, USA, Oxford University Press, 2004, cap. 8. <<
[12] Pharmaceutical CSO - Pharmaceutical Commercialization – Quintiles [Internet]. Disponible en http://www.quintiles.com/commercial-services/. <<
[13] «Drug testing goes offshore», 8 de agosto de 2005 [Internet] [citado el 11 de febrero de 2012]. Disponible en http://money.cnn.com/magazines/fortune/fortune_archive/2005/08/08/8267653/index.htm. <<
[14] Thiers, F. A., Sinskey, A. J., Berndt, E. R., «Trends in globalization of clinical trials», Nature Reviews Drug Discovery, vol. 7, n.° 1, enero de 2008, págs. 13-14. <<
[15] Los aspectos de los ensayos clínicos en países en vías de desarrollo están bien analizados en dos libros: Shah, S., The Body Hunters: Testing New Drugs on the World’s Poorest Patients, New Press, 2007, y Petryna, A., When Experiments Travel: Clinical Trials and the Global Search for Human Subjects, Princeton University Press, 2009. <<
[16] Seth W. Glickman, M. D., M. B. A., John, G., McHutchinson, M. D., Eric D. Peterson, M. D., M. P. H., Charles B. Cairns, M. D., Robert A. Harrington, M. D., Robert M. Califf, M. D., y Kevin A. Schulman, M. D., «Ethical and Scientific Implications of the Globalization of Clinical Research», New England Journal of Medicine, vol. 360, 19 de febrero de 2009, págs. 816-823. <<
[17] Bansal, N., «The opportunities and challenges in conducting clinical trials globally», Clinical Research and Regulatory Affairs, 9 de febrero de 2012, págs. 1-6. <<
[18] Seth W. Glickman, M. D., John, G., McHutchinson, M. D., Eric D. Peterson, M. D., M. P. H., Charles B. Cairns, M. D., Robert A. Harrington, M. D., Robert M. Califf, M. D., y Kevin A. Schulman, M. D., págs. 816-823. <<
[19] Hyder, A. A., Wali, S. A., Khan, A. N., Teoh, N. B., Kass, N. E., Dawson, L., «Ethical review of health research: a perspective from developing country researchers», Journal of Medical Ethics, vol. 30, n.° 1, febrero de 2004, págs. 68-72. <<
[20] Zhang, D., Yin, P., Freemantle, N., Jordan, R., Zhong, N., Cheng, K. K., «An assessment of the quality of randomised controlled trials conducted in China», Trials, vol. 9, 2008, pág. 22. <<
[21] Thomas Smith, W., «FDA Requires Foreign Clinical Studies be in Accordance with Good Clinical Practice to Better Protect Human Subjects», American Bar Association Health eSource, octubre de 2008, vol. 5, n.° 2 [Internet] [citado el 11 de febrero de 2012]. Disponible en http://www.americanbar.org/newsletter/publications/aba_health_esource_home/Volume5_02_smith.html. <<
[22] WíkiLeaks cables: «Pfizer used dirty tricks to avoid clinical trial payout», Business - The Guardian [Internet] [citado el 11 de febrero de 2012]. Disponible en http://www.guardian.co.uk/business/2010/dec/09/wikileaks-cables-pfizer-nigeria. <<
[23] Telegrama embajada USA, lunes 20 de abril de 2009, 16:00, Abuja 000671 «Pfizer reaches preliminary agreement for $75m settlement» [citado el 11 de febrero de 2012]. Disponible en http://www.theguardian.com/world/us-embassy-cables-documents/203205. <<
[24] WikiLeaks cables: «Pfizer used dirty tricks to avoid clinical trial payout», Business - The Guardian [Internet] [citado el 11 de febrero de 2012]. Disponible en http://www.theguardian.com/business/2010/dec/09/wikileaks-cables-pfizer-nigeria. <<
[25] Kimmelman, J., Weijer, Ch. y Meslin, E. M., «Helsinki discords: FDA, ethics, and international drug trials», The Lancet vol. 373, n.° 9. 657, 3 de enero de 2009, págs. 13-14. <<
[26] Goodyear MDE, Lemmens T., Sprumont, D., Tangwa, D., «Does the FDA have the authority to trump the Declaration of Helsinki?», British Medical Journal, vol. 338, 21 de abril de 2009, b1559. <<