Prizes and Parasites: Incentive Models for Addressing Chagas Disease

Trouiller P. Olliaro P. Torreele E. Orbinski J. Laing R. Ford N. , “Drug Development For Neglected Diseases,” The Lancet 360, no. 9339 (2002): 1102.

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).

Sachs J. D. , Macroeconomics and Health: Investing in Health for Economic Development, Report of the Commission on Macroeconomics and Health, Geneva, World Health Organization, 2001.

See Trouiller , supra note 1.

Hotez P. J. Ottesen E. Fenwick A. 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): 23–33.

Patz J. A. 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): 5635–5636.)

Kington T. , “Climate Change Brings Malaria Back to Italy,” The Guardian (London), January 6, 2007: 20.

Centers for Disease Control and Prevention, “Blood Donor Screening for Chagas Disease—United States, 2006–2007,” MMWR 56, no. 7 (2007): 141–3

Hotez P. J. Ferris M. T. , “The Anitpoverty Vaccines,” Vaccine 24 (2006): 5787–5799.

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).

Bryce J. Boschi-Pinto C. Shibuya K. Black R. E. , “WHO Estimates of the Causes of Death in Children,” The Lancet 365, no 9465 (2005): 1147–1152.

Hotez P. J. , “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. , Control of Neglected Tropical Diseases, New England Journal of Medicine 357, no. 10 (2007): 1018–1027.

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.

Bethony J. Brooker S. Albonico M. Geiger S. M. Loukas A. , “Soiltransmitted Helminth Infections: Ascariasis, Trichuriasis, and Hookworm,” The Lancet 367, no. 9521 (2006): 1521–1532; Hotez , “Incorporating a Rapid-impact Package for Neglected Tropical Diseases with Programs for HIV/AIDS, Tuberculosis, and Malaria,” supra note 15.

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).

Franco-Paredes C. Von A. Hidron A. Rodriguez-Morales A. J. Tellez I. , “Chagas Disease: An Impediment in Achieving the Millennium Development Goals in Latin America,” BMC Internal Health and Human Rights 7, no. 7 (2007): 7–12.

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.

Hubbard T. Love J. P. , “A New Trade Framework for Global Healthcare R&D,” PLoS Biology 2, no. 2 (2004): 147–150.

Dentico N. Ford N. , “The Courage to Change the Rules: A Proposal for an Essential Health R&D Treaty,” PLoS Medicine 2, no. 2 (2005): 14.

Maskus K. Reichman J. , “The Globalization of Private Knowledge Goods and the Privatization of Global Public Goods,” Journal of International Economic Law 7, no. 2 (2004): 279–320.

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).

See Correa , supra note 21.

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): 679–715; 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.

Love J. Hubbard T. , “The Big Idea: Prizes to Stimulate R&D for New Medicines,” KEI Research Paper 1 (2007): 1519–1544, adapted from the Ruby Hutchison Memorial Address, Nov. 12, 2006.

Love J. , “Drug Development Incentives to Improve Access to Essential Medicines,” supra note 27.

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).

Stiglitz J. , “Give Prizes not Patents,” New Scientist (2006): 21.

See <http://www.xprize.org/> (last visited February 23, 2009).

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).

“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.

Working Document Proposed by Barbados and Bolivia, Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (2008). On file with author.

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.

See Hotez Ferris , supra note 12.

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).

Bern C. Montgomery S. P. Katz L. Caglioti S. Stramer S. L. , “Chagas Disease and the US Blood Supply,” Current Opinion in Infectious Disease 21, no. 5 (2008): 476–82.

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.

Woodall J. , “Soda, With a Side of Chagas,” The Scientist 21, no. 11 (2007): 73–73.

See Gillespie Pearson , supra note 40.

For a comprehensive review of Chagas drug development, see Rodrigues Coura J. de Castro S. L. , “Critical Review on Chagas Disease,” Chemotherapy Memorias Do Instituto Oswaldo Cruz 97, no. 1 (2002): 3–24.

Id; Magil A. Reed S. , Hunter's Tropical Medicine , 8th ed. (Philadelphia: W. B. Saunders Company, 2000): 653–663.

See Coura de Castro , supra note 43.

See Magil Reed , supra note 44.

Guillemot D. Carbon C. Balkau B. “Low Dosage and Long Treatment Duration of Beta-Lactam: Risk Factors for Carriage of Penicillin-Resistant Streptococcus Pneumoniae,” JAMA 279, no. 5 (1998): 365–370.

Zhang Y. , “Advances in the Treatment of Tuberculosis,” Clinical Pharmacology and Therapeutics 82, no. 5 (2007): 595–600.

Rassi A. Jr. Pinto Dias J. C. Antonio Marin-Neto J. Rassi A. , “Challenges and Opportunities for Primary, Secondary, and Tertiary Prevention of Chagas Disease,” Heart (published online January 8, 2009).

Hotez P. J. Ferris M. T. , “The Anitpoverty Vaccines,” Vaccine 24, no. 31–32 (2006): 5787–5799.

See Rassi Jr. , supra note 49; Prata A. , “Natural History of Chagasic Cardiomyopathy in America: Trypanosomiasis Research,” Pan American Health Organization Science Publications 318, no. 4 (1975): 191–193.

Jannin J. Villa L. , “An Overview of Chagas Disease Treatment,” Memorias Do Instituto Oswaldo Cruz, Rio de Janeiro 102, supplement I (2007): 95–98.

Maguire J. H. Hoff R. Sherlock I. Guimaraes A. C. Sleigh A. C. Ramos N. B. Mott K. E. Weller T. H. , “Cardiac Morbidity and Mortality due to Chagas' Disease: Prospective Electrocardiographic Study of a Brazilian Community,” Circulation 75 (1987): 1140–1145.

See Gillespie Pearson , supra note 40.

Prata A. , “Clinical and Epidemiological Aspects of Chagas Disease,” The Lancet Infectious Diseases 1, no. 2 (2001): 92–100.

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.

Kirchhoff L. V. , “American Trypanosomiasis (Chagas' Disease) – A Tropical Disease Now in the United States,” New England Journal of Medicine 329, no. 9 (1993): 639–644.

Cox F. E. , “Designer Vaccines for Parasitic Diseases,” International Journal of Parasitology 27, no. 10 (1997): 1147–1157.

Hisaeda H. Yasutomo K. , “Malaria: Immune Evasion by Parasites,” International Journal Biochemistry and Cell Biology 37, No. 4 (2005): 700–6.

Williamson W. A. Greenwood B. M. , “Impairment of the Immune Response to Vaccination after Acute Malaria,” Lancet 1, no. 8078 (1978): 1328–9.

Da'Dara A. A. Lautsch N. , “Helminth Infection Suppresses T-cell Immune Response to HIV-DNA-based Vaccine in Mice,” Vaccine 24, no. 24 (2006): 5211–5219.

Guinovart C. 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.

See Cox , supra note 64.

See Hotez Ferris , supra note 52.

El-Sayed N. M. Myler P. J. Bartholomeu D. Nilsson D. Aggarwal G. Tran A. N. , “The Genome Sequence of Trypanosoma Cruzi, Etiologic Agent of Chagas Disease,” Science 309, no. 5733 (2005): 409–15.

Tarleton R. L. , “The Trypanosoma cruzi proteome,” Science 309 (2005): 473–6.

Fontanella G. H. De Vusser K. , “Immunization with an Engineered Mutant Transsialidase Highly Protects Mice from Experimental Trypanosoma Cruzi Infection: A Vaccine Candidate,” Vaccine 26, no. 19 (2008): 2322–2334; Cazorla S. I. Frank F. M. , “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. 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.

Frank F. M. Petray P. B. Cazorla S. I. Munoz M. C. Corral R. S. 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): 77–86.

See Cazorla Frank , supra note 71; Frank , supra note 72; Cazorla S. I. Becker P. D. , “Oral Vaccination with Salmonella Enterica as a Cruzipain-DNA Delivery System Confers Protective Immunity against Trypanosoma Cruzi,” Infection and Immunity 76, no. 1 (2008): 324–333; Schnapp A. R. Eickhoff C. S. Sizemore D. Curtiss R. III Hoft D. F. , “Cruzipain Induces both Mucosal and Systemic Protection against Trypanosoma Cruzi in Mice,” Infection and Immunity 70, no. 9 (2002): 5065–5074.

See Cazorla Frank , supra note 71.

Wizel B. Nunes M. Tarleton R. L. , “Identification of Trypanosoma cruzi Transsialidase Family Members as Targets of Protective CD8+ TC1 Responses,” Journal of Immunology 159, no. 6 (1997): 6120–6130.

Chou B. , “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): 241–250.

Tarleton R. L. , “New Approaches in Vaccine Development for Parasitic Infections,” Cell Microbiology 7, no. 10 (2005):1379–86.

See Alexandre , supra note 71.

Garg N. Bhatia V. , “Current Status and Future Prospects for a Vaccine Against American Trypanosomiasis,” Expert Review of Vaccines 4, no. 6 (2007): 867–880. (.

Chamond N. Coatnoan N. Minoprio P. , “Immunotherapy of Trypanosoma cruzi Infections,” Current Drug Targets – Immune, Endocrine, and Metabolic Disorders 2, no. 3 (2002): 247–254.

See Garg Bhatia , supra note 79.

Brener Z. Gazzinelli R. T. , “Immunological Control of Trypanosoma Cruzi Infection and Pathogenesis of Chagas' Disease,” International Archives of Allergy and Immunology 114, no. 2 (1997): 103–110.

Jurk M. Vollmer J. , “Therapeutic Applications of Synthetic CpG Oligodeoxynucleotides as TLR9 Agonists for Immune Modulation,” BioDrugs 21, no. 6 (2007): 387–401.

Hoft D. F. Eickhoff C. S. Giddings O. K. Vasconcelos J. R. 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): 6889–6900; de Alencar B. C. Araújo A. F. Penido M. L. Gazzinelli R. T. 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.

Miyahira Y. Takashima Y. , “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): 7356–7365.

Bhatia B. Garg N. , “Previously Unrecognized Vaccine Candidates Control Trypanosoma Cruzi Infection and Immunopathology in Mice,” Clinical and Vaccine Immunology 15, no. 8 (2008): 1158–1164; Katae M. Miyahira Y. , “Coadministration of an Interleukin-12 Gene and a Trypanosoma Cruzi Gene Improves Vaccine Efficacy,” Infection and Immunity 70, no. 9 (2002): 4833–4840.

Bejon P. Kai O. K. Mwacharo J. Keating S. Lang T. Gilbert S. C. Peshu N. Marsh K. 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): 2264–2272.

See Cazorla Becker , supra note 81.

See Hoft , supra note 93.

See Cazorla Frank , supra note 71.

Crampton A. Vanniasinkam T. , “Parasite Vaccines: The New Generation,” Infection, Genetics and Evolution 7, no. 5 (2007) 664–673.

Kostense S. Koudstaal W. Sprangers M. Weverling G. J. Penders G. Helmus N. Vogels R. Bakker M. Berkhout B. Havenga M. Goudsmit J. , “Adenovirus Types 5 and 35 Seroprevalence in AIDS Risk Groups Supports Type 35 as a Vaccine Vector,” AIDS 18, no. 8 (2004): 1213–1216.

Ledford H. , “HIV Vaccine May Raise Risk,” Nature News 450 (2007): 325–325.

See Hotez Ferris , supra note 52.

Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH), Public Health, Innovation and Intellectual Property Rights, 2006.

See Crampton Vanniasinkam , supra note 92.

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): 810–822.

Caetano B. C. Bruna-Romero O. Fux B. Mendes E. A. Penido M. L. 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): 415–426.

Rothel J. S. Boyle D. B. Both G. W. Pye A. D. Waterkeyn J. G. Wood P. R. 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): 221–227.

Ophorst O. J. Radosevic K. Havenga M. J. Pau M. G. Holterman L. Berkhout B. Goudsmit J. 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): 313–320; see Bejon , supra note 87; Hutchings C. L. Birkett A. J. Moore A. C. 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;

Stewart V. A. McGrath S. M. Dubois P. M. Pau M. G. Mettens P. Shott J. , “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): 2283–2290.