«Dallas Buyers Club (2013)»: la investigación clínica con fármacos durante la epidemia del sida de los años 80

Marian de HAAN-BOSCH, Josep?E BAÑOS, Álvaro GÓMEZ?TOMÁS, Magí FARRÉ

Resumen


La película Dallas Buyers Club (2013), inspirada en hechos reales, narra la historia de Ron Woodroof, un electricista de mediana edad natural de Dallas (Texas), que es diagnosticado de sida en 1985. Sin apenas opciones de tratamiento, funda el club de compradores de Dallas con el fin de suministrar fármacos no aprobados por la Food and Drug Administration (FDA) a la comunidad afectada por la enfermedad. Como director del club, Ron se verá inmerso en constantes viajes de negocios, disputas con la FDA y problemas con la justicia y el fisco (Internal Revenue System, IRS). En el artículo se presenta un análisis detallado del fenómeno de los clubes de compradores en EEUU, los fármacos citados en la película y el ensayo clínico con zidovudina que se muestra en el largometraje. El filme podría ser útil como herramienta docente para transmitir conceptos relacionados con la epidemia del sida, la investigación clínica y el desarrollo de fármacos, la bioética de la investigación en humanos y las agencias que regulan el acceso y aprobación de medicamentos. Por último, se proporciona un posible esquema de trabajo para el uso de la película en un entorno docente.


Palabras clave


History of Medicine; Motion Pictures; Trauma; Violence; Wounds and Injuries; historia de la medicina; cine; traumatismo; violencia; heridas; lesiones

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Referencias


FARRÉ M, ARRIBAS S, Pérez J, BAÑOS J. El uso de películas comerciales para com‐ prender los principios bioéticos en la investigación clínica. Rev Med Cine [Internet]. Diciembre 2013 [Consultado el 2014 Jul 14]; 9:151‐155. Disponible en: http://fundacion.usal.es/revistamedicina/nuevo/component/docman/doc_dow nload/doc_download

FARRÉ M, BOSCH F, ROSET PN, BAÑOS JE. Putting clinical pharmacology in context: the use of popular movies. J Clin Pharmacol. 2004; 44:30‐36.

BAÑOS JE, BOSCH F, PÉREZ J et al. Al cruzar el límite/Extreme Measures: cine, prin‐ cipios bioéticos e investigación clínica. Rev Med Cine [Internet]. 2011 [Consultado el 2014 Jul 14]; 7:95‐99. Disponible en: http://revistamedicinacine.usal.es/ index.php/es/vol7/num3/661

VENTURA S, Onsman A. The use of popular movies during lectures to aid teach‐ ing and learning of undergraduate pharmacology. Med Teacher. 2009; 31:662‐64.

RON WOODROOF BIOGRAPHY. The Biography.com website [Internet]. 2014 [Consultado el 2014 Jul 18]. Disponible en: http://www.biography.com/people/ ron‐woodroof‐21329541

DOCKTERMAN E. The True Story of Dallas Buyers Club. Time [Internet]. 2013 Nov 8 [Consultado el 2014 Jul 18]. Disponible en: http://entertainment.time.com/ 2013/11/08/the‐true‐story‐of‐dallas‐buyers‐club

MINUTAGLIO B. The real legacy of the real Dallas Buyers Club is that it didn’t real‐ ly have one. The Guardian [Internet]. 2 de marzo de 2014 [Consultado el 2014 Jul 17]. Disponible en: http://www.theguardian.com/commentisfree/2014/mar/02/ real‐dallas‐buyers‐club‐matthew‐mcconaughey‐character

MULLARD A. Underground drug networks in the early days of AIDS. Lancet. 2014; 383:592. Disponible en: http://www.thelancet.com/journals/lancet/article/ PIIS0140‐6736(14)60208‐7/fulltext

MINUTAGLIO B. Buying Time, How Dallas got to be a center of the black market in unapproved AIDS drugs. Dallas Life Magazine [Internet]. 9 de agosto de 1992 [Consultado el 2014 Jul 15]. Disponible en: http://buyersclubdallas.com

TRILLO P. Los otros Dallas Buyers Club. El Mundo [Internet]. 23 de marzo de 2014 [Consultado el: 2014 Jul 21]. Disponible en: http://www.elmundo.es/inter‐ nacional/2014/03/22/532dcb90ca47417a278b457e.html

BRODER S. The development of antiretroviral therapy and its impact on the HIV‐ 1/AIDS pandemic. Antiviral Res. 2010; 85:1–18. Disponible en: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2815149

MITSUYA H, WEINHOLD KJ, FURMAN PA, St Clair MH, Nusinoff‐Lehrman S, Gallo RC, et al. 3ʹ‐azido‐3ʹ‐deoxythymidine (BW A509U): an antiviral agent that inhibits the infectivity and cytopathic effect of human T‐lymphotropic virus type III/lym‐ phadenopathy‐associated virus in vitro. Proc Natl Acad Sci USA. 1985; 82:7096–7100. Disponible en: http://www.pnas.org/content/82/20/7096.full.pdf

YARCHOAN R, KLECKER RW, WEINHOLD KJ, MARKHAM PD, LYERLY HK, DURACK DT, GELMANN E, et al. Administration of 3ʹ‐azido‐3ʹdeoxythymidine, an inhibitor of HTLV‐III/LAV replication, to patients with AIDS or AIDS‐related complex. Lancet. 1986; 1:575–580.

FISCHL MA, RICHMAN DD, GRIECO MH, GOTTLIEB MS, VOLBERDING PA, LASKIN OL, et al. The efficacy of azidothymidine (AZT) in the treatment of patients with AIDS and AIDS‐related complex. A double‐blind, placebo‐controlled trial. N Engl J Med. 1987; 317:185–191.

FISCHL MA, PARKER CB, PETTINELLI C, WULFSOHN M, HIRSCH MS, COLLIER AC, et al. A Randomized Controlled Trial of a Reduced Daily Dose of Zidovudine in Patients with the Acquired Immunodeficiency Syndrome. N Engl J Med. 1990; 323:1009‐1014. Disponible en: http://www.nejm.org/doi/full/10.1056/NEJM199010113231501

DOURNON E, MATHERON S, ROZENBAUM W, MICHON C, PERRONNE C, DE TRUCHIS P, et al. Effects of zidovudine in 365 consecutive patients with AIDS or AIDS‐related complex. Lancet. 1998; 2:1297‐1302.

PERT CB, HILL JM, RUFF MR, BERMAN RM, ROBEY GW, ARTHUR LO, et al. Octapeptides deduced from the neuropeptide receptor‐like pattern of antigen T4 in brain potently inhibit human immunodeficiency virus receptor binding and T‐ cell infectivity. Proc Natl Acad Sci USA. 1986; 83:9254–9258. Disponible en: http://www.pnas.org/content/83/23/9254.long

POLIANOVA MT, RUSCETTI FW, PERT CB, TRACTENBERG RE, LEOUNG G, RUFF MR, et al. Antiviral and immunological benefits in HIV patients receiving intranasal peptide T (DAPTA). Peptides. 2003; 24:1093–1098.

KOECH DK, OBEL AO, MINOWADA J, HUTCHINSON VA, CUMMINS JM. Low dose oral alpha‐interferon therapy for patients seropositive for human immunodeficiency virus type‐1 (HIV‐1). Mol Biother. 1990; 2:91‐95.

KAISER G, JAEGER H, BIRKMANN J, POPPINGER J, CUMMINS JM, GALLMEIER WM. Low‐dose oral natural human interferon‐alpha in 29 patients with HIV‐1 infection: a double‐blind, randomized, placebo‐controlled trial. AIDS. 1992; 6:563‐569.

ROZENBAUM W, GHARAKHANIAN S, NAVARETTE MS, DE SAHB R, ROUZIOUX C. Long‐ term follow‐up of 120 patients with AIDS‐related Kaposi’s sarcoma treated with interferon alpha‐2a. J Invest Dermatol. 1990; 95(6 Suppl):161S‐165S.

AMERICAN Thoracic Society. Fungal infection in HIV‐infected persons. Am J Respir Crit Care Med. 1995; 152:816‐822.

SONNABEND JA. Review of AZT multicenter trial data [Internet]. 1987 Oct [Consultado el 2014 Jul 22] Disponible en: http://aidsperspective.net/ articles/AZT_TRIALA.pdf

WORLD MEDICAL ASSOCIATION. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. JAMA. 2013; 310:2191‐2194.

IOANNIDIS J. Effectiveness of antidepressants: an evidence myth constructed from a thousand randomized trials?. Philos Ethics Humanit Med. 2008; 27;3:14. Disponible en: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2412901

FARRÉ M, ARRIBAS S, Pérez J, BAÑOS J. El uso de películas comerciales para com‐ prender los principios bioéticos en la investigación clínica. Rev Med Cine [Internet]. Diciembre 2013 [Consultado el 2014 Jul 14]; 9:151‐155. Disponible en: http://fundacion.usal.es/revistamedicina/nuevo/component/docman/doc_dow nload/doc_download

FARRÉ M, BOSCH F, ROSET PN, BAÑOS JE. Putting clinical pharmacology in context: the use of popular movies. J Clin Pharmacol. 2004; 44:30‐36.

BAÑOS JE, BOSCH F, PÉREZ J et al. Al cruzar el límite/Extreme Measures: cine, prin‐ cipios bioéticos e investigación clínica. Rev Med Cine [Internet]. 2011 [Consultado el 2014 Jul 14]; 7:95‐99. Disponible en: http://revistamedicinacine.usal.es/ index.php/es/vol7/num3/661

VENTURA S, Onsman A. The use of popular movies during lectures to aid teach‐ ing and learning of undergraduate pharmacology. Med Teacher. 2009; 31:662‐64.

RON WOODROOF BIOGRAPHY. The Biography.com website [Internet]. 2014 [Consultado el 2014 Jul 18]. Disponible en: http://www.biography.com/people/ ron‐woodroof‐21329541

DOCKTERMAN E. The True Story of Dallas Buyers Club. Time [Internet]. 2013 Nov 8 [Consultado el 2014 Jul 18]. Disponible en: http://entertainment.time.com/ 2013/11/08/the‐true‐story‐of‐dallas‐buyers‐club

MINUTAGLIO B. The real legacy of the real Dallas Buyers Club is that it didn’t real‐ ly have one. The Guardian [Internet]. 2 de marzo de 2014 [Consultado el 2014 Jul 17]. Disponible en: http://www.theguardian.com/commentisfree/2014/mar/02/ real‐dallas‐buyers‐club‐matthew‐mcconaughey‐character

MULLARD A. Underground drug networks in the early days of AIDS. Lancet. 2014; 383:592. Disponible en: http://www.thelancet.com/journals/lancet/article/ PIIS0140‐6736(14)60208‐7/fulltext

MINUTAGLIO B. Buying Time, How Dallas got to be a center of the black market in unapproved AIDS drugs. Dallas Life Magazine [Internet]. 9 de agosto de 1992 [Consultado el 2014 Jul 15]. Disponible en: http://buyersclubdallas.com

TRILLO P. Los otros Dallas Buyers Club. El Mundo [Internet]. 23 de marzo de 2014 [Consultado el: 2014 Jul 21]. Disponible en: http://www.elmundo.es/inter‐ nacional/2014/03/22/532dcb90ca47417a278b457e.html

BRODER S. The development of antiretroviral therapy and its impact on the HIV‐ 1/AIDS pandemic. Antiviral Res. 2010; 85:1–18. Disponible en: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2815149

MITSUYA H, WEINHOLD KJ, FURMAN PA, St Clair MH, Nusinoff‐Lehrman S, Gallo RC, et al. 3ʹ‐azido‐3ʹ‐deoxythymidine (BW A509U): an antiviral agent that inhibits the infectivity and cytopathic effect of human T‐lymphotropic virus type III/lym‐ phadenopathy‐associated virus in vitro. Proc Natl Acad Sci USA. 1985; 82:7096–7100. Disponible en: http://www.pnas.org/content/82/20/7096.full.pdf

YARCHOAN R, KLECKER RW, WEINHOLD KJ, MARKHAM PD, LYERLY HK, DURACK DT, GELMANN E, et al. Administration of 3ʹ‐azido‐3ʹdeoxythymidine, an inhibitor of HTLV‐III/LAV replication, to patients with AIDS or AIDS‐related complex. Lancet. 1986; 1:575–580.

FISCHL MA, RICHMAN DD, GRIECO MH, GOTTLIEB MS, VOLBERDING PA, LASKIN OL, et al. The efficacy of azidothymidine (AZT) in the treatment of patients with AIDS and AIDS‐related complex. A double‐blind, placebo‐controlled trial. N Engl J Med. 1987; 317:185–191.

FISCHL MA, PARKER CB, PETTINELLI C, WULFSOHN M, HIRSCH MS, COLLIER AC, et al. A Randomized Controlled Trial of a Reduced Daily Dose of Zidovudine in Patients with the Acquired Immunodeficiency Syndrome. N Engl J Med. 1990; 323:1009‐1014. Disponible en: http://www.nejm.org/doi/full/10.1056/NEJM199010113231501

DOURNON E, MATHERON S, ROZENBAUM W, MICHON C, PERRONNE C, DE TRUCHIS P, et al. Effects of zidovudine in 365 consecutive patients with AIDS or AIDS‐related complex. Lancet. 1998; 2:1297‐1302.

PERT CB, HILL JM, RUFF MR, BERMAN RM, ROBEY GW, ARTHUR LO, et al. Octapeptides deduced from the neuropeptide receptor‐like pattern of antigen T4 in brain potently inhibit human immunodeficiency virus receptor binding and T‐ cell infectivity. Proc Natl Acad Sci USA. 1986; 83:9254–9258. Disponible en: http://www.pnas.org/content/83/23/9254.long

POLIANOVA MT, RUSCETTI FW, PERT CB, TRACTENBERG RE, LEOUNG G, RUFF MR, et al. Antiviral and immunological benefits in HIV patients receiving intranasal peptide T (DAPTA). Peptides. 2003; 24:1093–1098.

KOECH DK, OBEL AO, MINOWADA J, HUTCHINSON VA, CUMMINS JM. Low dose oral alpha‐interferon therapy for patients seropositive for human immunodeficiency virus type‐1 (HIV‐1). Mol Biother. 1990; 2:91‐95.

KAISER G, JAEGER H, BIRKMANN J, POPPINGER J, CUMMINS JM, GALLMEIER WM. Low‐dose oral natural human interferon‐alpha in 29 patients with HIV‐1 infection: a double‐blind, randomized, placebo‐controlled trial. AIDS. 1992; 6:563‐569.

ROZENBAUM W, GHARAKHANIAN S, NAVARETTE MS, DE SAHB R, ROUZIOUX C. Long‐ term follow‐up of 120 patients with AIDS‐related Kaposi’s sarcoma treated with interferon alpha‐2a. J Invest Dermatol. 1990; 95(6 Suppl):161S‐165S.

AMERICAN Thoracic Society. Fungal infection in HIV‐infected persons. Am J Respir Crit Care Med. 1995; 152:816‐822.

SONNABEND JA. Review of AZT multicenter trial data [Internet]. 1987 Oct [Consultado el 2014 Jul 22] Disponible en: http://aidsperspective.net/ articles/AZT_TRIALA.pdf

WORLD MEDICAL ASSOCIATION. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. JAMA. 2013; 310:2191‐2194.

IOANNIDIS J. Effectiveness of antidepressants: an evidence myth constructed from a thousand randomized trials?. Philos Ethics Humanit Med. 2008; 27;3:14. Disponible en: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2412901








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