Hostname: page-component-78c5997874-j824f Total loading time: 0 Render date: 2024-11-05T04:52:00.079Z Has data issue: false hasContentIssue false

Prizes and Parasites: Incentive Models for Addressing Chagas Disease

Published online by Cambridge University Press:  01 January 2021

Extract

Despite the enormous progress made in the advancement of health technologies over the last century, infectious diseases continue to cause significant morbidity and mortality in developing countries. Neglected diseases are a subset of infectious diseases that lack treatments that are effective, simple to use, or affordable. Neglected diseases primarily affect populations in poor countries that do not constitute a lucrative market sector, thus failing to provide incentives for the pharmaceutical industry to conduct R&D for these diseases. Of the treatments that do exist for neglected diseases, most are completely out-dated, with poor side-effect profiles, cumbersome logistics of administration, and inadequate efficacy. Historically, the impetus for a majority of neglected disease research was driven by early 20th-century colonialism, and in the post-colonial era, these diseases have been virtually ignored. Of the 1556 New Chemical Entities (NCEs) brought to market during the 30-year period from 1975 to 2004, only 20 — less than 0.02% — were for neglected diseases.

Type
Symposium
Copyright
Copyright © American Society of Law, Medicine and Ethics 2009

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Trouiller, P., Olliaro, P., Torreele, E., Orbinski, J., Laing, R. and Ford, N., “Drug Development For Neglected Diseases,” The Lancet 360, no. 9339 (2002): 1102.Google Scholar
Report of the WHO Commission on Macroeconomics and Health, Presented to the 55th World Healh Assembly, April 23, 2002, avaliable at <www.who.int/macrohealth/en/> (last visited March 9, 2009).+(last+visited+March+9,+2009).>Google Scholar
Sachs, J. D. et al., Macroeconomics and Health: Investing in Health for Economic Development, Report of the Commission on Macroeconomics and Health, Geneva, World Health Organization, 2001.Google Scholar
See Trouiller, et al., supra note 1.Google Scholar
Hotez, P. J., Ottesen, E., Fenwick, A. and Molyneux, D., “The Neglected Tropical Diseases: The Ancient Afflictions of Stigma and Poverty and the Prospects for their Control and Elimination,” Advances in Experimental Medicine and Biology 582 (2006): 2333.CrossRefGoogle Scholar
Patz, J. A. and Olson, S. H., “Malaria Risk and Temperature: Influences from Global Climate Change and Local Land Use Practices,” Proceedings of the National Academy of Sciences USA 103, no. 15 (2006): 56355636.)CrossRefGoogle Scholar
Kington, T., “Climate Change Brings Malaria Back to Italy,” The Guardian (London), January 6, 2007: 20.Google Scholar
Centers for Disease Control and Prevention, “Blood Donor Screening for Chagas Disease—United States, 2006–2007,” MMWR 56, no. 7 (2007): 141–3Google Scholar
Hotez, P. J. and Ferris, M. T., “The Anitpoverty Vaccines,” Vaccine 24 (2006): 57875799.CrossRefGoogle Scholar
Roll Back Malaria Partnership, Economic Costs of Malaria, available at <http://rbm.who.int/cmc_upload/0/000/015/363/RBMInfosheet_10.htm> (last visited February 20, 2009).+(last+visited+February+20,+2009).>Google Scholar
Bryce, J., Boschi-Pinto, C., Shibuya, K., Black, R. E. and “WHO Estimates of the Causes of Death in Children,” The Lancet 365, no 9465 (2005): 11471152.CrossRefGoogle Scholar
Hotez, P. J. et al., “Incorporating a Rapid-impact Package for Neglected Tropical Diseases with Programs for HIV/AIDS, Tuberculosis, and Malaria,” Public Library of Science (PLoS) Medicine 3 (2006): e102; Hotez, P. J. et al., Control of Neglected Tropical Diseases, New England Journal of Medicine 357, no. 10 (2007): 1018-1027.Google Scholar
Disability-adjusted life years are a measure of overall disease burden that combines morbidity and mortality into a single metric, with one DALY being equal to one year of healthy life lost. DALYs are used commonly in the field of health impact assessment.Google Scholar
Bethony, J., Brooker, S., Albonico, M., Geiger, S. M. and Loukas, A. et al., “Soiltransmitted Helminth Infections: Ascariasis, Trichuriasis, and Hookworm,” The Lancet 367, no. 9521 (2006): 15211532; Hotez, et al., “Incorporating a Rapid-impact Package for Neglected Tropical Diseases with Programs for HIV/AIDS, Tuberculosis, and Malaria,” supra note 15.CrossRefGoogle Scholar
World Health Organization, World Health Report 2004: Changing History, Burden of Disease in DALYs by Cause, Sex and Mortality Stratum in WHO Regions, Estimates for 2002, Annex Table 3 (Geneva: World Health Organization, 2004), available at http://www.who.int/whr/2004/en/> (last visited February 23, 2009).+(last+visited+February+23,+2009).>Google Scholar
Franco-Paredes, C., Von, A., Hidron, A., Rodriguez-Morales, A. J. and Tellez, I. et al., “Chagas Disease: An Impediment in Achieving the Millennium Development Goals in Latin America,” BMC Internal Health and Human Rights 7, no. 7 (2007): 712.CrossRefGoogle Scholar
Correa, C. M., “New ICTSD (International Center for Trade and Sustainable Development) Series on New Opportunities Through Innovation: Fostering R&D and Promoting Access to Medicines,” Paper delivered October 22–26, 2007, Bellagio, Italy.Google Scholar
Hubbard, T. and Love, J. P., “A New Trade Framework for Global Healthcare R&D,” PLoS Biology 2, no. 2 (2004): 147150.CrossRefGoogle Scholar
Dentico, N. and Ford, N., “The Courage to Change the Rules: A Proposal for an Essential Health R&D Treaty,” PLoS Medicine 2, no. 2 (2005): 14.CrossRefGoogle Scholar
Maskus, K. and Reichman, J., “The Globalization of Private Knowledge Goods and the Privatization of Global Public Goods,” Journal of International Economic Law 7, no. 2 (2004): 279320.CrossRefGoogle Scholar
World Trade Organization, Declaration on the TRIPS agreement and Public Health, adopted on November 14, 2001, avaiable at <www.who.org/english/theWTO_e/minist_e/min01_e/mindecl_trips_e.htm> (last visited March 9, 2009).+(last+visited+March+9,+2009).>Google Scholar
See Correa, , supra note 21.Google Scholar
Love, J., “Measures to Enhance Access to Medical Technologies, and New Methods of Stimulating Medical R&D,” University of California Davis Law Review 40, no. 3 (2007): 679715; Love, J., “Drug Development Incentives to Improve Access to Essential Medicines,” Bulletin of the World Health Organization 84, no. 5 (2006): 408-411; Pogge, T., “Human Rights and Global Health: A Research Program,” Metaphilosophy 36, no. 1-2 (2005) 182-209.Google Scholar
Love, J. and Hubbard, T., “The Big Idea: Prizes to Stimulate R&D for New Medicines,” KEI Research Paper 1 (2007): 15191544, adapted from the Ruby Hutchison Memorial Address, Nov. 12, 2006.Google Scholar
Love, J., “Drug Development Incentives to Improve Access to Essential Medicines,” supra note 27.Google Scholar
National Institute for Health Care Management (NIHCM), Changing Patterns of Pharmaceutical Innovation (2002), available at <http://www.nihcm.org/innovations.pdf> (last visited February 25, 2009).+(last+visited+February+25,+2009).>Google Scholar
Stiglitz, J., “Give Prizes not Patents,” New Scientist (2006): 21.Google Scholar
See <http://www.xprize.org/> (last visited February 23, 2009).+(last+visited+February+23,+2009).>Google Scholar
New, W., “WHO Adopts ‘Most Important Document Since Doha’ On IP And Public Health,” Intellectual Property Watch (2008), avaiable at <www.ip-watch.org/weblog/> (last visited March 9, 2009).+(last+visited+March+9,+2009).>Google Scholar
“Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property,” Sixty-first World Health Assembly, WHA61.21 Agenda item 11.6. May 24, 2008.Google Scholar
Working Document Proposed by Barbados and Bolivia, Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (2008). On file with author.Google Scholar
Working Document Proposed by Barbados and Bolivia, Proposal 2: Prize for the Development of New Treatments for Chagas Disease, Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (2008). On file with author.Google Scholar
See Hotez, and Ferris, , supra note 12.Google Scholar
Centers for Disease Control and Prevention, Division of Parasitic Diseases, Chagas Disease Epidemiology and Risk Factors, available at <http://www.cdc.gov/chagas/epi.html> (last visited February 23).+(last+visited+February+23).>Google Scholar
Bern, C., Montgomery, S. P., Katz, L., Caglioti, S. and Stramer, S. L., “Chagas Disease and the US Blood Supply,” Current Opinion in Infectious Disease 21, no. 5 (2008): 476–82.CrossRefGoogle Scholar
Gillespie, S. H., Pearson, R. D., ed., Principles and Practice of Clinical Parasitology (New York: John Wiley & Sons, Ltd, 2001). Chapter 14b: American Trypanosomiasis: 335–353.CrossRefGoogle Scholar
Woodall, J., “Soda, With a Side of Chagas,” The Scientist 21, no. 11 (2007): 7373.Google Scholar
See Gillespie, and Pearson, , supra note 40.Google Scholar
For a comprehensive review of Chagas drug development, see Coura, J. Rodrigues, de Castro, S. L., “Critical Review on Chagas Disease,” Chemotherapy Memorias Do Instituto Oswaldo Cruz 97, no. 1 (2002): 324.CrossRefGoogle Scholar
Id; Magil, A. and Reed, S., Hunter's Tropical Medicine, 8th ed. (Philadelphia: W. B. Saunders Company, 2000): 653663.Google Scholar
See Coura, and de Castro, , supra note 43.Google Scholar
See Magil, and Reed, , supra note 44.Google Scholar
Guillemot, D., Carbon, C. and Balkau, B. et al. “Low Dosage and Long Treatment Duration of Beta-Lactam: Risk Factors for Carriage of Penicillin-Resistant Streptococcus Pneumoniae,” JAMA 279, no. 5 (1998): 365370.CrossRefGoogle Scholar
Zhang, Y., “Advances in the Treatment of Tuberculosis,” Clinical Pharmacology and Therapeutics 82, no. 5 (2007): 595600.CrossRefGoogle Scholar
Rassi, A. Jr., Dias, J. C. Pinto, Marin-Neto, J. Antonio and Rassi, A., “Challenges and Opportunities for Primary, Secondary, and Tertiary Prevention of Chagas Disease,” Heart (published online January 8, 2009).Google Scholar
Hotez, P. J. and Ferris, M. T., “The Anitpoverty Vaccines,” Vaccine 24, no. 31–32 (2006): 57875799.CrossRefGoogle Scholar
See Rassi, Jr. et al., supra note 49; Prata, A., “Natural History of Chagasic Cardiomyopathy in America: Trypanosomiasis Research,” Pan American Health Organization Science Publications 318, no. 4 (1975): 191193.Google Scholar
Jannin, J. and Villa, L., “An Overview of Chagas Disease Treatment,” Memorias Do Instituto Oswaldo Cruz, Rio de Janeiro 102, supplement I (2007): 9598.CrossRefGoogle Scholar
Maguire, J. H., Hoff, R., Sherlock, I., Guimaraes, A. C., Sleigh, A. C., Ramos, N. B., Mott, K. E. and Weller, T. H., “Cardiac Morbidity and Mortality due to Chagas' Disease: Prospective Electrocardiographic Study of a Brazilian Community,” Circulation 75 (1987): 11401145.CrossRefGoogle Scholar
See Gillespie, and Pearson, , supra note 40.Google Scholar
Prata, A., “Clinical and Epidemiological Aspects of Chagas Disease,” The Lancet Infectious Diseases 1, no. 2 (2001): 92100.CrossRefGoogle Scholar
Centers for Disease Control and Prevention, “Blood Donor Screening for Chagas Disease – United States, 2006–2007,” MMWR Morbidity and Mortality Weekly Report 56, no. 7 (2007): 141–3.Google Scholar
Kirchhoff, L. V., “American Trypanosomiasis (Chagas' Disease) – A Tropical Disease Now in the United States,” New England Journal of Medicine 329, no. 9 (1993): 639644.Google Scholar
Cox, F. E., “Designer Vaccines for Parasitic Diseases,” International Journal of Parasitology 27, no. 10 (1997): 11471157.CrossRefGoogle Scholar
Hisaeda, H. and Yasutomo, K. et al., “Malaria: Immune Evasion by Parasites,” International Journal Biochemistry and Cell Biology 37, No. 4 (2005): 700–6.CrossRefGoogle Scholar
Williamson, W. A. and Greenwood, B. M., “Impairment of the Immune Response to Vaccination after Acute Malaria,” Lancet 1, no. 8078 (1978): 1328–9.CrossRefGoogle Scholar
Da'Dara, A. A. and Lautsch, N. et al., “Helminth Infection Suppresses T-cell Immune Response to HIV-DNA-based Vaccine in Mice,” Vaccine 24, no. 24 (2006): 52115219.CrossRefGoogle Scholar
Guinovart, C. and Alonso, P.L., “Methods for Determining Vaccine Efficacy and Effectiveness and the Main Barriers to Developing Fully Deployable Malaria Vaccine,” American Journal of Tropical Medicine and Hygiene 77, No. 6, suppl (2007): 276–81.CrossRefGoogle Scholar
See Cox, , supra note 64.Google Scholar
See Hotez, and Ferris, , supra note 52.Google Scholar
El-Sayed, N. M., Myler, P. J., Bartholomeu, D., Nilsson, D., Aggarwal, G. and Tran, A. N. et al., “The Genome Sequence of Trypanosoma Cruzi, Etiologic Agent of Chagas Disease,” Science 309, no. 5733 (2005): 409–15.CrossRefGoogle Scholar
Tarleton, R. L., “The Trypanosoma cruzi proteome,” Science 309 (2005): 473–6.Google Scholar
Fontanella, G. H. and De Vusser, K. et al., “Immunization with an Engineered Mutant Transsialidase Highly Protects Mice from Experimental Trypanosoma Cruzi Infection: A Vaccine Candidate,” Vaccine 26, no. 19 (2008): 23222334; Cazorla, S. I. and Frank, F. M. et al., “Prime-boost Immunization with Cruzipain Co-administered with MALP-2 Triggers a Protective Immune Response able to Decrease Parasite Burden and Tissue Injury in an Experimental Trypanosoma Cruzi Infection Model,” Vaccine 7, no. 26 (2008): 1999-2009; Vasconcelos, J. R., Hiyane, M. I., Marinho, C. R. F., Claser, C., Alexandre, V., Machado, V., Gazzinelli, R. T., Bruna-Romero, O., Alvarez, J. M., Boscardin, S. B. and Rodrigues, M. M., “Protective Immunity Against Trypanosoma Cruzy Infection in a Highly Susceptivle Mouse Strain After Vaccination with Genes Encoding the Amastigote Sruface Protein-2 and Trans-Sialidase,” Human Gene Therapy 15, no. 9 (2004): 878-886.CrossRefGoogle Scholar
Frank, F. M., Petray, P. B., Cazorla, S. I., Munoz, M. C., Corral, R. S. and Malchiodi, E. L., “Use of a Purified Trypanosoma Cruzi Antigen and CpG Oligodeoxynucleotides for Immunoprotection against a Lethal Challenge with Trypomastigotes,” Vaccine 22, no. 1 (2003): 7786.CrossRefGoogle Scholar
See Cazorla, and Frank, et al., supra note 71; Frank, et al., supra note 72; Cazorla, S. I. and Becker, P. D. et al., “Oral Vaccination with Salmonella Enterica as a Cruzipain-DNA Delivery System Confers Protective Immunity against Trypanosoma Cruzi,” Infection and Immunity 76, no. 1 (2008): 324333; Schnapp, A. R., Eickhoff, C. S., Sizemore, D., Curtiss, R. III and Hoft, D. F., “Cruzipain Induces both Mucosal and Systemic Protection against Trypanosoma Cruzi in Mice,” Infection and Immunity 70, no. 9 (2002): 5065–5074.CrossRefGoogle Scholar
See Cazorla, and Frank, et al., supra note 71.Google Scholar
Wizel, B., Nunes, M. and Tarleton, R. L., “Identification of Trypanosoma cruzi Transsialidase Family Members as Targets of Protective CD8+ TC1 Responses,” Journal of Immunology 159, no. 6 (1997): 61206130.Google Scholar
Chou, B. et al., “Critical Contribution of Immunoproteasomes in the Induction of Protective Immunity against Trypanosoma Cruzi in Mice Vaccinated with A Plasmid Encoding A CTL Epitope Fused to Green Fluorescence Protein,” Microbes and Infection 10, no. 3 (2008): 241250.CrossRefGoogle Scholar
Tarleton, R. L., “New Approaches in Vaccine Development for Parasitic Infections,” Cell Microbiology 7, no. 10 (2005):1379–86.CrossRefGoogle Scholar
See Alexandre, et al., supra note 71.Google Scholar
Garg, N. and Bhatia, V., “Current Status and Future Prospects for a Vaccine Against American Trypanosomiasis,” Expert Review of Vaccines 4, no. 6 (2007): 867880. (.CrossRefGoogle Scholar
Chamond, N., Coatnoan, N. and Minoprio, P., “Immunotherapy of Trypanosoma cruzi Infections,” Current Drug Targets – Immune, Endocrine, and Metabolic Disorders 2, no. 3 (2002): 247254.Google Scholar
See Garg, and Bhatia, , supra note 79.Google Scholar
Brener, Z. and Gazzinelli, R. T., “Immunological Control of Trypanosoma Cruzi Infection and Pathogenesis of Chagas' Disease,” International Archives of Allergy and Immunology 114, no. 2 (1997): 103110.CrossRefGoogle Scholar
Jurk, M. and Vollmer, J., “Therapeutic Applications of Synthetic CpG Oligodeoxynucleotides as TLR9 Agonists for Immune Modulation,” BioDrugs 21, no. 6 (2007): 387401.CrossRefGoogle Scholar
Hoft, D. F., Eickhoff, C. S., Giddings, O. K., Vasconcelos, J. R. and Rodrigues, M. M., “Transsialidase Recombinant Protein Mixed with CpG Motif-containing Oligodeoxynucleotide Induces Protective Mucosal and Systemic Trypanosoma Cruzi Immunity Involving CD8+ CTL and B Cell-mediated Cross-Priming,” Journal of Immunology 179, no. 10 (2007): 68896900; de Alencar, B. C., Araújo, A. F., Penido, M. L., Gazzinelli, R. T. and Rodrigues, M. M., “Cross-priming of Long Lived Protective CD8+ T Cells against Trypanosoma Cruzi Infection: Importance of a TLR9 Agonist and CD4+ T cells,” Vaccine 25, no. 32 (2007): 6018-27.CrossRefGoogle Scholar
Miyahira, Y. and Takashima, Y. et al., “Immune Responses Against a Single CD8+-T-Cell Epitope Induced by Virus Vector Vaccination Can Successfully Control Trypanosoma cruzi Infection,” Infection and Immunity 73, no. 11 (2005): 73567365.CrossRefGoogle Scholar
Bhatia, B. and Garg, N., “Previously Unrecognized Vaccine Candidates Control Trypanosoma Cruzi Infection and Immunopathology in Mice,” Clinical and Vaccine Immunology 15, no. 8 (2008): 11581164; Katae, M. and Miyahira, Y. et al., “Coadministration of an Interleukin-12 Gene and a Trypanosoma Cruzi Gene Improves Vaccine Efficacy,” Infection and Immunity 70, no. 9 (2002): 4833-4840.CrossRefGoogle Scholar
Bejon, P., Kai, O. K., Mwacharo, J., Keating, S., Lang, T., Gilbert, S. C., Peshu, N., Marsh, K. and Hill, A. V. S., “Alternating Vector Immunizations Encoding Pre-erythrocytic Malaria Antigens Enhance Memory Responses in a Malaria Endemic Area,” European Journal of Immunology 36, no. 8 (2006): 22642272.CrossRefGoogle Scholar
See Cazorla, and Becker, et al., supra note 81.Google Scholar
See Hoft, et al., supra note 93.Google Scholar
See Cazorla, and Frank, et al., supra note 71.Google Scholar
Crampton, A. and Vanniasinkam, T., “Parasite Vaccines: The New Generation,” Infection, Genetics and Evolution 7, no. 5 (2007) 664673.CrossRefGoogle Scholar
Kostense, S., Koudstaal, W., Sprangers, M., Weverling, G. J., Penders, G., Helmus, N., Vogels, R., Bakker, M., Berkhout, B., Havenga, M. and Goudsmit, J., “Adenovirus Types 5 and 35 Seroprevalence in AIDS Risk Groups Supports Type 35 as a Vaccine Vector,” AIDS 18, no. 8 (2004): 12131216.CrossRefGoogle Scholar
Ledford, H., “HIV Vaccine May Raise Risk,” Nature News 450 (2007): 325325.CrossRefGoogle Scholar
See Hotez, and Ferris, , supra note 52.Google Scholar
Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH), Public Health, Innovation and Intellectual Property Rights, 2006.Google Scholar
See Crampton, and Vanniasinkam, , supra note 92.Google Scholar
Perez-Jimenez, E., Kochan, G., Gherardi, M. M., Esteban, M., “MVA-LACK as a Safe and Efficient Vector for Vaccination against Leishmaniasis,” Microbes and Infection 8, no. 3 (2006): 810822.CrossRefGoogle Scholar
Caetano, B. C., Bruna-Romero, O., Fux, B., Mendes, E. A., Penido, M. L. and Gazzinelli, R. T., “Vaccination with Replication-deficient Recombinant Adenoviruses Encoding the Main Surface Antigens of Toxoplasma Gondii Induces Immune Response and Protection Against Infection in Mice,” Human Gene Therapy 17, no. 4 (2006): 415426.CrossRefGoogle Scholar
Rothel, J. S., Boyle, D. B., Both, G. W., Pye, A. D., Waterkeyn, J. G., Wood, P. R. and Lightowlers, M. W., “Sequential Nucleic Acid and Recombinant Adeno Virus Vaccination Induces Host-protective Immune Responses against Taenia Ovis Infection in Sheep,” Parasite Immunology 19, no. 5 (1997): 221227.CrossRefGoogle Scholar
Ophorst, O. J., Radosevic, K., Havenga, M. J., Pau, M. G., Holterman, L., Berkhout, B., Goudsmit, J. and Tsuji, M., “Immunogenicity and Protection of a Recombinant Human Adenovirus Serotype 35-based Malaria Vaccine against Plasmodium Yoelii in Mice,” Infections and Immunity 74, no. 1 (2006): 313320; see Bejon, et al., supra note 87; Hutchings, C. L., Birkett, A. J., Moore, A. C. and Hill, A. V. S., “Combination of Protein and Viral Vaccines Induces Potent Cellular and Humoral Immune Responses and Enhanced Protection from Murine Malaria Challenge,” Infection and Immunity 75, no. 12 (2007): 5819–5826;CrossRefGoogle Scholar
Stewart, V. A., McGrath, S. M., Dubois, P. M., Pau, M. G., Mettens, P. and Shott, J. et al., “Priming with an Adenovirus 35-circumsporozoite Protein (CS) Vaccine Followed by RTS, S/AS01B Boosting Significantly Improves Immunogenicity to Plasmodium Falciparum CS Compared to that with Either Malaria Vaccine Alone,” Infections and Immunity 75, no. 5 (2007): 22832290.CrossRefGoogle Scholar