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Vol. 28. Núm. S4.
Uso prudente de antimicrobianos
Páginas 45-49 (noviembre 2010)
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Vol. 28. Núm. S4.
Uso prudente de antimicrobianos
Páginas 45-49 (noviembre 2010)
Acceso a texto completo
El papel de la industria farmacéutica. ¿Por qué no se comercializan nuevos antibióticos?
The role of the pharmaceutical industry. Why aren’t new antibiotics being marketed?
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César García-Rey
Consultor Independiente de Microbiología y Enfermedades Infecciosas, SEIMC, Madrid, España
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Resumen

El escaso o nulo interés social y político en el problema de las resistencias a antibióticos, la dificultad en la identificación de moléculas activas frente a nuevas dianas, pero, sobre todo, su baja rentabilidad relativa frente a otras clases de fármacos, así como la incertidumbre y arbitrariedad por parte de las autoridades regulatorias a la hora de evaluar su eficacia, están en la base de la enorme reducción en el ritmo de comercialización de nuevos antibióticos. Las condiciones actuales no favorecen la inversión en nuevos antibióticos por parte de la industria farmacéutica, que tiene a su disposición áreas terapéuticas con mucha mayor rentabilidad potencial y otros problemas propios de los que ocuparse. Ya que no se puede forzar a la industria a desarrollar antibióticos habrá que implementar lo antes posible políticas que estimulen su interés en ellos, o bien encontrar la manera de que los diferentes estados y autoridades sustituyan a la industria farmacéutica en esta tarea.

Palabras clave:
Industria farmacéutica
Investigación y desarrollo (I+D)
Antibióticos
Rentabilidad
Abstract

The lack or absence of social and political interest in the problem of antibiotic resistance, the difficulty in identifying active molecules against new targets, and above all, low profitability in comparison to other types of drugs, as well as uncertainty and the arbitrary nature of regulatory authorities in terms of assessing effectiveness, all contribute to a significant slowdown in the marketing of new antibiotics. Current conditions do not favor investment in new antibiotics by the pharmaceutical industry, which has available therapeutic areas with far greater profit potential, and other problems of its own to handle. Since we cannot force the industry to develop antibiotics, it is necessary to implement policies as soon as possible that stimulate interest in developing them, or find a way for the states and regulatory authorities to replace the pharmaceutical industry in this task.

Keywords:
Pharmaceutical industry
Research and development (R&D)
Antibiotics
Profitability
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Bibliografía
[1.]
Leading causes of death. Centers for Disease Control and Prevention. Disponible en: http://www.cdc.gov/nchs/fastats/lcod.htm
[2.]
Informe OMS 2004 “Priority Medicines for Europe and the World”. Disponible en: http://whqlibdoc.who.int/hq/2004/WHO_EDM_PAR_2004.7.pdf
[3.]
S.E. Cosgrove, Y. Carmeli.
The impact of antimicrobial resistance on health and economic outcomes.
Clin Infect Dis, 36 (2003), pp. 1433-1437
[4.]
S.E. Cosgrove.
The relationship between antimicrobial resistance and patient outcomes: mortality, length of hospital stay, and health care costs.
Clin Infect Dis, 42 (2006), pp. S82-S89
[5.]
R.M. Klevens, J.R. Edwards, R.P. Gaynes, National Nosocomial Infections Surveillance System.
The impact of antimicrobial-resistant, health care-associated infections on mortality in the United States.
Clin Infect Dis, 47 (2008), pp. 927-930
[6.]
H.W. Boucher, G.R. Corey.
Epidemiology of methicillin-resistant Staphylococcus aureus.
Clin Infect Dis, 46 (2008), pp. S344-S349
[7.]
Infectious Diseases Society of America. Bad Bugs, No Drugs. As antibiotic discovery stagnates… A public health crisis brews. Alexandria, VA. 2004.
[8.]
B. Spellberg, J.H. Powers, E.P. Brass, L.G. Miller, J.E. Edwards Jr.
Trends in antimicrobial drug development: Implications for the future.
Clin Infect Dis, 38 (2004), pp. 1279-1286
[9.]
G.H. Talbot, J. Bradley, J.E. Edwards Jr, D. Gilbert, M. Scheld, J.G. Bartlett.
Bad bugs need drugs: an update on the development pipeline from the Antimicrobial Availability Task Force of the Infectious Diseases Society of America.
Clin Infect Dis, 42 (2006), pp. 657-668
[10.]
B. Spellberg, R. Guidos, D. Gilbert, J. Bradley, H.W. Boucher, W.M. Scheld, et al.
The epidemic of antibiotic resistant infections: a call to action for the medical community from the Infectious Diseases Society of America.
Clin Infect Dis, 46 (2008), pp. 155-164
[11.]
H.W. Boucher, G.H. Talbot, J.S. Bradley, J.E. Edwards, D. Gilbert, L.B. Rice, et al.
Bad Bugs, No Drugs: No ESKAPE! An update from the Infectious Diseases Society of America.
Clin Infect Dis, 48 (2009), pp. 1-12
[12.]
Infectious Diseases Society of America.
The 10×20 Initiative: Pursuing a global commitment to develop 10 new antibacterial drugs by 2020.
Clin Infect Dis, 50 (2010), pp. 1081-1083
[13.]
A. Coates, Y. Hu, R. Bax, C. Page.
The future challenges facing the development of new antimicrobial drugs.
Nature Rev, 1 (2002), pp. 895-910
[14.]
F.A. Amer, E.M. El-Behedy, H.A. Mohtady.
New targets for antibacterial agents.
Biotech Mol Biol Rev, 3 (2008), pp. 46-57
[15.]
M. Baer, T. Sawa, P. Flynn, K. Luehrsen, D. Martínez, J.P. Wiener-Kronish, et al.
An engineered human antibody fab fragment specific for Pseudomonas aeruginosa PcrV antigen has potent antibacterial activity.
Infect Immun, 77 (2009), pp. 1083-1090
[16.]
D.J. Payne, M.N. Gwynn, D.J. Holmes, D.L. Pompliano.
Drugs for bad bugs: confronting the challenging of antibacterial discovery.
Nat Rev Drug Discov, 1 (2007), pp. 29-40
[17.]
S.J. Projan, et al.
Late stage antibacterial drugs in the clinical pipeline.
Curr Opinion Microbiol, 10 (2007), pp. 441-446
[18.]
J.L. Martínez, F. Baquero, D.I. Andersson.
Predicting antibiotic resistance.
Nat Rev Microbiol, 5 (2007), pp. 958-965
[19.]
C. García-Rey, L. Aguilar, F. Baquero, J. Casal, R. Dal-Ré.
Importance of local variations in antibiotic consumption and geographical differences of erythromycin and penicillin resistance in Streptococcus pneumoniae.
J Clin Microbiol, 40 (2002), pp. 159-164
[20.]
T. Pi-Sunyer Cañellas, M. Banqué Navarro, N. Freixas Sala, F. Barcenilla Gaite.
Higiene de las manos: evidencia científica y sentido común.
Med Clin Monogr (Barc), 131 (2008), pp. 56-59
[21.]
A. Fenoll, J.J. Granizo, L. Aguilar, M.J. Giménez, L. Aragoneses-Fenoll, G. Hanquet, et al.
Temporal trends of invasive Streptococcus pneumoniae serotypes and antimicrobial resistance patterns in Spain from 1979 to 2007.
J Clin Microbiol, 47 (2009), pp. 1012-1020
[22.]
J. Casal, M.J. Giménez, L. Aguilar, J. Yuste, I. Jado, D. Tarragó, et al.
Beta-lactam activity against resistant pneumococcal strains is enhanced by the immune system.
J Antimicrob Chemother, 50 (2002), pp. 83-86
[23.]
W.C. Albrich, D.L. Monnet, S. Harbarth.
Antibiotic selection pressure and resistance in Streptococcus pneumoniae and Streptococcus pyogenes.
Emerg Infect Dis, 10 (2004), pp. 514-517
[24.]
The Harris Poll® #90, August 18, 2009. Humphrey Taylor, Chairman, The Harris Poll, Harris Interactive. Disponible en: http://www.harrisinteractive.com/vault/Harris-Interactive-Poll-Research-Industry-Images-2009-08.pdf
[25.]
P.G.P. Charles, M.L. Grayson.
The dearth of new antibiotic development: why we should be worried and what we can do about it.
Med J Aust, 181 (2004), pp. 549-553
[26.]
J.A. Dimasi, R.W. Hansen, H.G. Grabowski.
The price of innovation: new estimates of drug development costs.
J Health Econ, 22 (2003), pp. 151-185
[27.]
C.P. Adams, V.V. Brantner.
Estimating the cost of new drug development: Is it really $802 million?.
Health Aff (Millwood), 2 (2006), pp. 420-428
[28.]
J.A. DiMasi, HG. Grabowski.
The cost of biopharmaceutical R&D: Is biotech different?.
Manage Decis Econ, 28 (2007), pp. 469-479
[29.]
The 2007 EU Industrial R&D Investment Scoreboard. JRC – Directorate General Research. Disponible en: http://iri.jrc.ec.europa.eu/research/scoreboard_2007.htms
[30.]
Informe de Investigación Sectorial sobre el Sector Farmacéutico. Comisión Europea 2009. Disponible en: http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/index.html
[31.]
Fortune Global 500. Top industries: Most profitable 2009. Disponible en: http://money.cnn.com/magazines/fortune/global500/2009/performers/industries/profits
[32.]
JP. Garnier.
Rebuilding the R&D engine in Big Pharma.
Harvard Business Review, (2008), pp. 69-76
[33.]
The Economist. Mar 17 2005 (IMS Health).
[34.]
PricewaterhouseCoopers 2007. Pharma 2020 The Vision – Which path will you take? Disponible en: http://www.pwc.com/gx/en/pharma-life-sciences/pharma-2020/pharma-2020-vision-path.jhtml
[35.]
The New York Times. Edición 13 Marzo 2009. Disponible en: http://www.nytimes.com/imagepages/2009/03/13/business/13place.graf01.ready.html
[36.]
S.J. Projan, D.M. Shlaes.
Antibacterial drug discovery: is it all downhill from here?.
Clin Microbiol Infect, 10 (2004), pp. 18-22
[37.]
J.L. Fox.
The business of developing antibacterials.
Nat Biotechnol, 24 (2006), pp. 1521-1528
[38.]
R.E. Christoffersen.
Antibiotics – an investment worth making?.
Nat Biotechnol, 24 (2006), pp. 1512-1514
[39.]
D.M. Schlaes, R.C. Moellering.
The United States Food and Drug Administration and the end of antibiotics.
Clin Infect Dis, 34 (2002), pp. 420-422
[40.]
P. Fernandes.
Antibacterial discovery and developement – the failure of success.
Nat Biotechnol, 24 (2006), pp. 1497
[41.]
Non-inferiority-trial discussions impact new drug applications. Nat Rev Drug Discov. 2009;8:1.
[42.]
D.N. Gilbert, J.E. Edwards.
Is there hope for the prevention of future antimicrobial shortages?.
Clin Infect Dis, 35 (2002), pp. 215-216
[43.]
D. Webber, M. Kremer.
Perspectives on stimulating industrial research and development for neglected infectious diseases.
Bull World Health Organ, 79 (2001), pp. 735-741
[44.]
C.M. Morel, E. Mossialos.
Stoking the antibiotic pipeline.
BMJ, 340 (2010), pp. c2115
[45.]
C. González, M. Rubio, J. Romero-Vivas, M. González, J.J. Picazo.
Bacteremic pneumonia due to Staphylococcus aureus: A comparison of disease caused by methicillin-resistant and methicillin-susceptible organisms.
Clin Infect Dis, 29 (1999), pp. 1171-1177
[46.]
S.J. Projan.
Why is big Pharma getting out of antibacterial drug discovery?.
Curr Opinion Microbiol, 6 (2003), pp. 427-430
Copyright © 2010. Elsevier España S.L.. Todos los derechos reservados
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