Sociología de la evaluación médicaproblemas metodológicos y contexto socioeconómico de los ensayos clínicos
ISSN: 0210-2862, 2013-9004
Año de publicación: 2014
Volumen: 99
Número: 1
Páginas: 119-144
Tipo: Artículo
Otras publicaciones en: Papers: revista de sociología
Resumen
Este artículo forma parte de un trabajo más amplio, que tiene como fin analizar el uso que se hace de los ensayos clínicos como forma de evaluar medicamentos. En otro lugar, presentamos la parte de ese trabajo correspondiente a los resultados obtenidos al estudiar tres casos concretos de evaluación de medicamentos. En este artículo, en cambio, al mismo tiempo que explicamos el interés que puede tener el mencionado trabajo y mostramos algunos problemas metodológicos asociados a la realización de los ensayos clínicos, analizamos el contexto socioeconómico en el que se mueve el mundo de la evaluación de medicamentos. Como conclusión a este artículo, indicamos que el contexto de la evaluación de medicamentos queda caracterizado por la existencia de una industria farmacéutica que es tan poderosa que condiciona la actuación del resto de los agentes que intervienen en el proceso de realización y evaluación de los ensayos clínicos, así como la divulgación de sus resultados. Al mismo tiempo, mostramos algunas limitaciones metodológicas de los ensayos que afectan tanto a su validez externa como a la interna, lo que limita el alcance de sus conclusiones.
Referencias bibliográficas
- Abraham, John (1993). Scientific standards and institutional interests, carcinogenic risk assessment of benoxaprofen in the UK and US. Social Studies of Science, 23, 387-444. <http://dx.doi.org/10.1177/0306312793023003001>
- Abraham, John (1995). Science, politics and the pharmaceutical industry, controversy and bias in drug regulation. Londres: UCL and St Martins Press.
- Abraham, John (2002). The pharmaceutical industry as a political player. The Lancet, 360, 1498-1502. <http://dx.doi.org/10.1016/S0140-6736(02)11477-2>
- Abraham, John (2008). Bias and science in knowledge production, implications for the politics of drug regulation». En: O’DOnOvan, O. y Glavanis-Grantham, K. (eds.). Power, Politics and Pharmaceuticals. Cork: Cork University Press, 43-57.
- Abraham, John (2009). The sociological concomitants of the pharmaceutical industry and medications. En: Conrad, P. et al. (eds.). American Sociological Association Handbook of Medical Sociology. Vanderbilt: Vanderbilt University Press, 25 p.
- Abraham, John y Davis, Courtney M. (2009). Drug evaluation and the permissive principle, continuities and contradictions between standards and practices in antidepressant clinical trial regulation. Social Studies of Science, 39, 569-598. <http://dx.doi.org/10.1177/0306312709103480>
- Abraham, John y Lewis, Graham (1998). Secrecy and transparency of medicines licensing in the EU. The Lancet, 352, 480-482. <http://dx.doi.org/10.1016/S0140-6736(97)11282-X>
- Abraham, John y Lewis, Graham (1999). Harmonising and competing for medicines regulation, how healthy are the European Union’s system of drug approval?. Social Science and Medicine, 48(11), 1655-1667. <http://dx.doi.org/10.1016/S0277-9536(99)00042-8>
- Als-Nielsen, Bodil; Chen, Wendong; Gluud, Christian y Kjaergard, Lise L. (2003). Association of funding and conclusions in randomized drug trials, a reflection of treatment effect or adverse events?. Journal of the American Medical Association, 290 (7), 921-928. <http://dx.doi.org/10.1001/jama.290.7.921>
- Altman, Douglas G. (2002). Poorquality medical research. Journal of the American Medical Association, 287, 2765-2767. <http://dx.doi.org/10.1001/jama.287.21.2765>
- Amón, Rubén (2003). Acusan a Glaxo de “comprar” médicos para que receten sus medicamentos. El País, 14 de febrero.
- Anand, Geeta (2005). Support System through Charities, Drug Makers Help People and Themselves. The Wall Street Journal, 1 de diciembre, A1.
- Angell, Marcia (2000). Is academic medicine for sale?. New England Journal of Medicine, 342, 1516-1518. <http://dx.doi.org/10.1056/NEJM200005183422009>
- Angell, Marcia (2004a). The Truth About The Drug Companies. The New York Review of Books, 51 (12) (15 de julio).
- Angell, Marcia (2004b). The Thruth about the Drug Companies: How They Deceive Us and What to Do About It. Nueva York: Random House.
- Angell, Marcia (2009). Drug Companies & Doctors, A Story of Corruption. The New York Review of Books, 15 de enero.
- Barbehenn, Elizabeth; Lurie, Peter y Wolfe, Sidney M. (2009). Alosetron for irritable bowel syndrome. The Lancet, 356 (9246), 2000.
- Barnes, Patricia M.; Powell-Griner, Eve; McFann, Kim y Nahin, Richard L. (2004). Complementary and alternative medicine use among adults, United States, 2002, 343 (27 de mayo), 1-19.
- Barnes, P. M.; Bloom, B. y Nahin, R. L. (2008). Complementary and alternative medicine use among adults and children, United States. National Health Statistics Report, 12 (10 de diciembre), 1-23.
- Bekelman, Justin F.; Yan, Li y Gross, Cari P. (2003). Scope and impact of financial conflicts of interest in biomedical research, a systematic review. Journal of the American Medical Association, 289 (4), 454-465. <http://dx.doi.org/10.1001/jama.289.4.454>
- Bhandari, M.; Busse, J. W.; Jackowski, D.; Montori, V. M.; Schunemann, H.; Sprague, S.; Mears, D.; Schemitsch, E. H.; Heels-Ansdell, D. y Devereaux, P. J. (2004). Association between industry funding and statistically significant proindustry findings in medical and surgical randomized trials. Canadian Medical Association Journal, 170, 477-480.
- BioSocieties (2007). The Construction and Governance of Randomised Controlled Trials. BioSocieties, 2 (1) (número especial).
- Blumenthal, D. (2004). Doctors and drug companies. New England Journal of Medicine, 351, 934-935. <http://dx.doi.org/10.1056/NEJMhpr042734>
- Bodenheimer, Thomas (2000). Uneasy alliance: Clinical investigators and the pharmaceutical industry. New England Journal of Medicine, 342 (20), 1539-1544. <http://dx.doi.org/10.1056/NEJM200005183422024>
- British Medical Journal (ed.) (1994). The scandal of poor medical research. British Medical Journal, 308, 283-284.
- Burton, Bob (2005). News roundup: Drug companies told that sponsoring patients’ groups might help win approval for their products. British Medical Journal, 331 (10 de diciembre), 1359.
- Califf, R. M. (2008). Clinical trials bureaucracy, unintended consequences of wellintentioned policy. Clinical Trials, 3 (6), 496-502. <http://dx.doi.org/10.1177/1740774506073173>
- Cameron, Danie J. (2006). Generalizability in two clinical trials of Lyme disease. Epidemiologic Perspectives & Innovations, 3, 12. <http://dx.doi.org/10.1186/1742-5573-3-12>
- Campbell, Eric G.; Weissman, J. S.; Ehringhaus, S.; Rao, S. R.; Moy, B. B.; Feibelmann, S. y Goold, S. D. (2007). Institutional academic industry relationships. Journal of the American Medical Association, 298 (15), 1779-1786. <http://dx.doi.org/10.1001/jama.298.15.1779>
- Carroll, K. M.; Nich, C.; McLellan, A. T.; McKay, J. R. y Rounsaville, B. J. (1999). “Research” versus “realworld” patients, representativeness of participants in clinical trials of treatments for cocaine dependence. Drug Alcohol Depend, 54 (2), 171-177. <http://dx.doi.org/10.1016/S0376-8716(98)00161-6>
- Cartwright, Nancy (2007). Are RCTs the Gold Standard?. BioSocieties, 2 (1), 11-20. <http://dx.doi.org/10.1017/S1745855207005029>
- Cauchon, Denis (2000). FDA advisers tied to industry. USA Today, 25 de septiembre.
- Cerdá, Hugo (2009). Demasiados conflictos de interés en investigaciones sobre cáncer. El País, 22 de septiembre.
- Cook, T. D. y Campbell, D. T. (1979). Quasi-experimentation: Design and analysis for field settings. Chicago: Rand McNally.
- Davidson, R. A. (1986). Source of funding and outcome of clinical trials. Journal General Internal Medicine, 1, 155-158. <http://dx.doi.org/10.1007/BF02602327>
- Davis, Courtney y Abraham, John (2009). Deconstructing Pharmaceutical “Science”, “Innovation”, and “Therapeutic Breakthrough”: A case study in the ideologies and realities of drug regulation in the US and supranational EU. Paper presentado en la Tracing Pharmaceuticals’ Conference. Universidad de Edimburgo, del 17 al 20 de junio de 2009.
- Davis, Courtney y Abraham, John (2010). Rethinking Innovation Accounting in Pharmaceutical Regulation: A case Study in the Deconstruction of Therapeutic Advance and Therapeutic Breakthrough. Science Technology Human Values OnlineFirst, 2 de agosto
- Duley, L.; Antman, K.; Arena, J.; Avezum, A.; Blumenthal, M.; Bosch, J.; Chrolavicius, S.; Li, T.; Ounpuu, S.; Perez, A. C.; Sleight, P.; Svard, R.; Temple, R.; Tsouderous, Y.; Yunis, C. y Yusuf, S. (2008). Specific barriers to the conduct of randomized trials. Clinical Trials, 5 (1), 40-48. <http://dx.doi.org/10.1177/1740774507087704>
- Easterbrook, P. J.; Berlin, J. A.; Gopalan, R. y Matthews, D. R. (1991). Publication bias in clinical research. The Lancet, 337 (8746) (13 de abril), 867-872.
- Eisenberg, David M.; Davis, Roger B.; Ettner, Susan L.; Appel, Scott; Wilkey, Sonja; Rompay, Maria van y Kessler, Ronald C. (1998). Trends in Alternative Medicine Use in the United States, 1990-1997: Results of a Followup National Survey. Journal of the American Medical Association, 280 (18) (11 de noviembre), 1569-1575. <http://dx.doi.org/10.1001/jama.280.18.1569>
- Escolá, Carles (2000a). 5.000 vendedores en el Congreso de Cardiología: Los laboratorios se vuelcan con cruceros y fiestas para 17.000 médicos reunidos en Barcelona. El País, 29 de agosto.
- Escolá, Carles (2000b). Al servicio de la industria farmacéutica: Los intereses comerciales prevalecen sobre los científicos en los ensayos clínicos de los hospitales universitarios. El País, 11 de julio.
- Espiño, Isabel (2005). La industria controla los estudios en muchas universidades americanas. El Mundo Salud, 26 de mayo.
- Gluud, Lise L. (2006). Unravelling industry bias in clinical trials. Pain, 121 (3), 175-176. <http://dx.doi.org/10.1016/j.pain.2006.01.001>
- Gotay, Carolyn C. (2006). Increasing Trial Generalizability. Journal of Clinical Oncology, 24 (6), 846-847. <http://dx.doi.org/10.1200/JCO.2005.04.5120>
- Hama, Rokuro (2003). Iressa should have never been aproved. ISDB Newsletter [en línea], 17. <http://npojip.org/iressa/iressaaISDB-Feb-2.html>
- Hemminki, A. y Kellokumpu-Lehtinen, P. (2006). Harmful impact of EU clinical trials directive. British Medical Journal, 332, 501-502. <http://dx.doi.org/10.1136/bmj.332.7540.501>
- Herxheimer, Andrew (2003). Relationships between the pharmaceutical industry and patients’ organisations. British Medical Journal, 326, 1208-1210. <http://dx.doi.org/10.1136/bmj.326.7400.1208>
- Hirst, Jenny (2003). Charities and patient groups should declare interests. British Medical Journal, 326 (31 de mayo), 1211.
- Holmberg, L.; Baum, M. y Adami, H. O. (1999). On the scientific inference from clinical trials. Journal of Evaluation in Clinical Practice, 5 (2), 157-162. <http://dx.doi.org/10.1046/j.1365-2753.1999.00206.x>
- Horton, Richards (2001). Lotronex and the FDA, a fatal erosion of integrity. The Lancet, 357 (9268). <http://dx.doi.org/10.1016/S0140-6736(00)04776-0>
- Jacobson, N. S.; Roberts, L. J.; Berns, S. B. y McGlinchey, J. B. (1999). Methods for defining and determining the clinical significance of treatment effects, description, application, and alternatives. Journal of Consulting and Clinical Psychology, 67, 300-301. <http://dx.doi.org/10.1037/0022-006X.67.3.300>
- Jadad, Alejandro R. (1998). The randomized controlled trial gets a middleaged checkup. Journal of the American Medical Association, 279, 319-320. <http://dx.doi.org/10.1001/jama.279.4.319>
- Jones, K. (2008). In whose interest?: Relationship between consumer groups and pharmaceutical industry in the UK. Sociology of Health and Illness, 30, 929-943. <http://dx.doi.org/10.1111/j.1467-9566.2008.01109.x>
- Jüni, Peter; Douglas, G. Altman y Egger, Mathias (2001). Assessing the quality of controlled clinical trials. British Medical Journal, 323, 42-46. <http://dx.doi.org/10.1136/bmj.323.7303.42>
- Kassirer, J. P. (2004). On the Take, How Medicine’s Complicity With Big Business Can Endanger Your Health. Nueva York: Oxford University Press.
- Kazdin, Alan E. (1999). The meanings and measurement of clinical significance. Journal of Consulting and Clinical Psychology, 67 (1), 332-339. <http://dx.doi.org/10.1037/0022-006X.67.3.332>
- Kjaergard, Lise L. y Als-Nielsen, Bodil (2002). Association between competing interests and authors’ conclusions: epidemiological study of randomised clinical trials published in the BMJ. British Medical Journal, 325 (7358), 249-252. <http://dx.doi.org/10.1136/bmj.325.7358.249>
- Kolata, Gina (2009). As other deaths rates fall, cancer scarcely moves. The New York Times, 24 de abril.
- Lasser, Kareen E.; Allen, Paul D.; Woolhandler, Steffie J.; Himmelstein, David V.; Wolf, Sidney M. y Bor, David H. (2002). Timing of new black-box warning and withdrawls from prescription medications. Journal of the American Medical Association, 287, 2215-2220. <http://dx.doi.org/10.1001/jama.287.17.2215>
- Lenzer, Jeanne (2002). Lay campaigners for prostate screening are funded by industry. British Medical Journal, 326 (29 de marzo), 680.
- Lexchin, Joel; Bero, Lisa A.; Djulbegovic, Benjamin y Clark, Otavio (2003). Pharmaceutical industry sponsorship and research outcome and quality, systematic review. British Medical Journal, 326, 1167-1170. <http://dx.doi.org/10.1136/bmj.326.7400.1167>
- Mechanic, D. (1968). Medical sociology. Nueva York: Free Press.
- Melander, Hans; Ahlqvist-Rastad, Jane; Meijer, Gertie y Björn, Beermann (2003). Evidence b(i)ased medicine-selective reporting from studies sponsored by pharmaceutical industry, review of studies in new drug applications. British Medical Journal, 326, 1171-1173. http://dx.doi.org/10.1136/bmj.326.7400.1171
- Mills, James L. (1993). Data torturing. New England Journal of Medicine, 329, 1196-1199. <http://dx.doi.org/10.1056/NEJM199310143291613>
- Montaner, Julio; O’Saughnessy, Michael V. y Schechter, Martin T. (2001). Industrysponsored clinical research, a doubleedged sword. The Lancet, 358, 1893-1895. <http://dx.doi.org/10.1016/S0140-6736(01)06891-X>
- Mosenifar, Zab (2007). Population issues in clinical trials. The Proceedings of the American Thoracic Society, 4, 185-188. <http://dx.doi.org/10.1513/pats.200701-009GC
- Moynihan, Ray (2003a). Who pays for the pizza? Redefining the relationship between doctors and the drug industry. 1: Entanglement. British Medical Journal, 326: 1189-1192. <http://dx.doi.org/10.1136/bmj.326.7400.1189>
- Moynihan, Ray (2003b). Who pays for the pizza? Redefining the relationship between doctors and the drug industry. 2: Disentanglement. British Medical Journal, 326: 1193-1196. <http://dx.doi.org/10.1136/bmj.326.7400.1193>
- Núñez Pagán, Ángel (2004). Implicaciones del nuevo Real Decreto sobre ensayos clínicos. Biomédica, 21de julio.
- PhRMA (2009). Pharmaceutical industry. Profile 2009. Phrma.
- Pitrou, I.; Boutron, I.; Ahmad, N. y Ravaud, P. (2009). Reporting of safety results in published reports of randomized controlled trials. Archives of Internal Medicine, 169, 1756-1761. <http://dx.doi.org/10.1001/archinternmed.2009.306>
- Poses, Roy M. (2009). Failing to Report Adverse Effects of Treatments. Blog Health Care Renewal, 28 de octubre.
- Public Citizen (2000a). Petition to the Food and Drug Administration to remove Lotronex from the market. Public Citizen HRG Publication #1533 (31 de agosto).
- Public Citizen (2000b). Letter to the Food and Drug Administration updating the number of cases of ischemic colitis reported in our 8/31/00 petition. Public Citizen HRG Publication #1544 (30 de octubre).
- Public Citizen (2000c). Letter to Lancet on Alosetron for irritation bowel syndrom showing data manipulation in a company-sponsored clinical trial. Public Citizen HRG Pbication #1551 (9 de diciembre).
- Public Citizen (2002). America’s other drug problem, a briefing book on the Rx drug debate. Public Citizen’s Congress Watch.
- Public Citizen (2003). 2002 Drug industry profits, hefty pharmaceutical company margins dwarf other industries. Public Citizen’s Congress Watch.
- Richards, Evelleen (1988). The politics of therapeutic evaluation, the vitamin C and cancer controversy. Social Studies of Science, 18, 653-701.
- Public Citizen (1991). Vitamin C and Cancer, Medicine or Politics? Londres. Macmillan.
- Sánchez Carrión, Juan Javier (2013). Sociología de la evaluación médica, estudio de casos. Revista Española de Investigaciones Sociológicas, 141: 133-158.
- Siahpush, Mohammad (1998). Postmodern values, dissatisfaction with conventional medicine and popularity of alternative therapies. Journal of Sociology, 34
- (1) (marzo), 58-70. <http://dx.doi.org/10.1177/144078339803400106>
- Siahpush, Mohammad (2000). A Critical Review of the Sociology of Alternative Medicine, Research on Users, Practitioners and the Orthodoxy. Health, 4 (2) (abril), 159-178.
- Stern, Jerome M. y Simes, R. John (1997). Publication bias, evidence of delayed publication in a cohort study of clinical research projects. British Medical Journal, 315, 640-645. <http://dx.doi.org/10.1136/bmj.315.7109.640>
- Surman, C. B.; Monuteaux, M. C.; Petty, C. R.; Faraone, S. V.; Spencer, T. J.; Chu, N. F. y Biederman, J. (2010). Representativeness of participants in a clinical trial for attention-deficit/hyperactivity disorder?: Comparison with adults from a large observational study. Journal of Clinical Psychiatry, 71 (12), 1612-1616.
- Tingey, R. C.; Lambert, M. J.; Burlingame, G. M. y Hansen, N. B. (1996). Assesing clinical significance, proposed extensions to method. Psychotherapy Research, 6, 109-123. <http://dx.doi.org/10.1080/10503309612331331638>
- Turner, Erik H.; Matthews, Annette M.; Linardatos, Eftihia; Tell, Robert A. y Rosenthal, Robert (2008). Selective Publication of Antidepressant Trials and Its Influence On Apparent Efficacy. The New England Journal of Medicine, 358, 252-260. <http://dx.doi.org/10.1056/NEJMsa065779>
- University of California at Berkeley (2002). The Novartis Agreement: An Appraisal, Administrative Review, 4 de octubre.
- Warde, Ibrahim (2001). Conflicts of interest in the campus. For sale, US academic integrity. Le Monde Diplomatique, marzo.
- Watson, Max (2006). Harmful impact of EU clinical trials directive: … and so has trial of melatonin in cancer related weight loss…. British Medical Journal, 332, 666. <http://dx.doi.org/10.1136/bmj.332.7542.666-a>
- Wazana, A. (2000). Physicians and the pharmaceutical industry, is a gift ever just a gift?. Journal of the American Medical Association, 283, 373-380. <http://dx.doi.org/10.1001/jama.283.3.373>
- Westen, Drew I. (2005). Patients and Treatments in Clinical Trials are not Adequately Representative of Clinical Practice. En: Norcross, John C. et al. (eds.). Evidence Based Practices in Mental Health. Washington D.C.: American Psychological Association.
- Will, Catherine M. (2007). The Alchemy of Clinical Trials. BioSocieties, 2 (1), 85-99.
- Willman, David (2000a). The rise and fall of the killer drug Razulin. Life Extension Magazine, septiembre.
- Willman, David (2000b). Drug Lotronex pulled over for safety fears. Los Angeles Times, 29 de noviembre.
- Willman, David (2000c). How a new policy led to seven deadly drugs. Los Angeles Times, 20 de diciembre.
- Willman, David (2000d). Lotronex, officer foresaw deadly effects. Los Angeles Times, 20 de diciembre.
- Wright, J. R.; Bouma, S.; Dayes, I. et al. (2006). The importance of reporting patient recruitment details in phase III trials. Journal of Clinical Oncology, 24, 843-845.
- Zanza, Gonzalo (2003). Una directiva europea puede acabar con una tercera parte de los ensayos clínicos españoles. ABC, 3 de septiembre.
- Zimmerman, Mark; Mattia, Jill I. y Posternak, Michael A. (2002). Are Subjects in Pharmacological Treatment Trials of Depression Representative of Patients in Routine Clinical Practice?. American Journal of Psychiatry, 159, 469-473.