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Artemisia Annua, Artemisinin, Acts & Malaria Control in Africa Tradition, Science and Public Policy

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Artemisia Annua, Artemisinin, Acts & Malaria Control in Africa Tradition, Science and Public Policy Cover_final_081012.qxd:Book 24/10/12 20:54 Page 4 Tradition, Science andPublic Policy Tradition, Artemisia annua The key ingredient in the most effective treatments for malaria in Africa - artemisinin - comes not from high-tech research, but is an extract of an ancient Chinese medicinal plant, Artemisia annua, commonly known as Artemisia. Chloroquine and inAfrica & Malaria Control , Artemisinin, ACTs replacement drugs have lost effectiveness with the development of resistance and have increasingly been replaced by derivatives of artemisinin Artemisia annua, combined with other drugs. Known as artemisinin–based combination therapies (ACTs), they provide the most effective treatment at Artemisinin, ACTs Dana G. Dalrymple is present. This has led to efforts to increase an agricultural cultivated production of Artemisia in the short run economist by vocation and to develop, through biological and chemical & Malaria Control and a historian by research, synthetic substitutes in the longer run. avocation. He spent most of his career with The resulting interplay provides both opportunities in Africa the U.S. government in international agricultural and challenges for society. While individual development and components have been examined, there is little in Tradition, Science and Public Policy research, first with the the way of comprehensive analysis. This paper Dept. of Agriculture attempts to weave the many complex and dynamic (USDA) and then on components - historical, scientific, technical, and detail to the Agency for economic - together in order to aid understanding Intl. Development of the issues and facilitate development of (USAID). He received informed public/private policies and actions. B.S. and M.S. degrees Although focused on Africa, the main components in pomology Dana G. Dalrymple (horticulture) and and issues are global in nature and resolution and agricultural economics relate to more general issues in infectious disease from Cornell University, control and economic development. and a Ph.D. in the latter from Michigan State University. ISBN: 978-0-615-61599-8 Dalrymple Dana G. Book_inside_171012.qxd:Book 24/10/12 20:30 Page 1 Book_inside_171012.qxd:Book 24/10/12 20:30 Page 2 CHAPTER 1: MANAGEMENT 2 Book_inside_171012.qxd:Book 24/10/12 20:30 Page 3 CHAPTER 1: MANAGEMENT As to diseases, make a habit of two things – to help, or at least to do no harm. Hippocrates, 460-377 BC The ends of this branch of knowledge [chemical philosophy] are the applications of natural substances to new uses, for increasing the comforts and enjoyments of man… Sir Humphry Davy, 1812 It would be foolhardy of anyone to predict when and how malaria will be conquered. Socrates Litsios, 1996 Book_inside_171012.qxd:Book 24/10/12 20:30 Page 4 Drawing of Artemisia Annua L. plant found on the bank of the Rhine River near Arnhem in September 1897 (in Kops, J., 1906) Book_inside_171012.qxd:Book 24/10/12 20:30 Page 5 Artemisia annua, Artemisinin, ACTs & Malaria Control in Africa Tradition, Science and Public Policy Dana G. Dalrymple Book_inside_171012.qxd:Book 24/10/12 20:30 Page 6 Copyright This work is not copyrighted. Library of Congress Control number: 2012429303 Printed by, and available from: POLITICS & PROSE BOOKSTORE 5015 Connecticut Ave, N.W. Washington D.C., 20008-2024 (202) 364-1919 [email protected] First printing April 2012 Second printing, with minor changes, June 2012 Third printing, with minor changes and addition of Annex 6, October 2012 Set in Novarese Book, 10.2 point Printed on an Espresso Book Machine Electronic version An electronic version is available from the MEDICINES FOR MALARIA VENTURE website www.mmv.org/artemisinin Picture credits Artemisia leaf, front cover et. seq. courtesy E. M. Croom, Jr., Oxford, Missouri. Frontispiece courtesy Wageningen University & Research Centre library special collections, Wageningen, Netherlands. Figure 2 p. 17 courtesy Wallace Peters. Figure 3 p. 18 courtesy Wallace Peters. Figure 4 p. 19 courtesy Wallace Peters. Figure 5 p. 26 courtesy Keith Arnold. Figure 6 p. 36 courtesy DK Images. Figure 7 p. 39 courtesy E. M. Croom, Jr., University of Mississippi. Figure 8 p. 42 courtesy Malcolm Cutler. Author photo: Chuck Palative. Book_inside_171012.qxd:Book 24/10/12 20:31 Page 7 CONTENTS Contents Preface xiii Acknowledgments xv 1.1. Introduction 1.1.1. The importance of malaria in Africa 1 1.1.2. Evolution of malaria control programs and emphases 3 1.1.2.1. International efforts 3 1.1.2.2. Shifts in donor emphases 4 1.1.3. Malaria and its treatment 5 1.1.4. Traditional medications and science 9 1.1.4.1. Artemisia teas 10 1.1.4.2. Herbal remedies 11 1.2. The Concept: Artemisinin-Based Combination Therapies 1.2.1. Artemisinin and its mode of action 15 1.2.2. The key initial role of China 16 1.2.2.1. Early development of artemisinin and external advice 17 1.2.2.2. Western interest in artemisinin and derivatives 20 1.2.2.3. Initial development of ACTs 21 1.2.3. Moving to a global stage 22 1.2.3.1. WHO endorsement of ACTs 22 1.2.3.2. Subsequent trials of ACTs and agitation for adoption 23 1.2.3.3. Growth in demand for artemisinin 24 1.2.4. Reprise: an internal view of China’s efforts 25 1.2.4.1. Project 523 27 1.2.4.2. Post-project 523 period 30 1.2.4.3. Development and gobalization of ACTs 31 1.2.4.4. Some key participants 32 1.3. The Components: Their Nature and Implementation 1.3.1. Artemisia: plant and production 35 1.3.1.1. The Artemisia plant 35 1.3.1.1.1. Botanical garden and genebank holdings 37 1.3.1.1.2. Varietal improvement programs 38 1.3.1.1.2.1. United States 38 1.3.1.1.2.2. Mainland Europe 40 1.3.1.1.2.3. United Kingdom 41 vii Book_inside_171012.qxd:Book 24/10/12 20:31 Page 8 CONTENTS 1.3.1.1.2.4. Latin America 44 1.3.1.1.3. Other plant qualities 45 1.3.1.1.4. Further plant sources of antimalarials 45 1.3.1.2. Artemisia production in Africa 46 1.3.2. Artemisinin: extraction and use in ACTs 49 1.3.2.1. Extraction of artemisinin 49 1.3.2.2. Monotherapies and co-formulations 51 1.3.2.3. Artemisinin derivatives and ACTs 52 1.3.2.4. Additional ACT combinations 56 1.3.2.5. Multiple combinations and terminology 56 1.3.3. ACTs: introduction and implementation 58 1.3.3.1. Initial availability of ACTs 58 1.3.3.2. Transition to ACTs in Africa 59 1.3.3.3. Development of resistance to ACTs 61 1.3.3.4. Nature of the ACT combination 62 1.3.3.5. Implications for manufacturers of monotherapies 64 1.3.3.6. Qualified and “unqualified” manufacturers 67 1.3.3.7. WHO guidelines for the use of ACTs 67 1.3.4. Artemisinins: drug discovery, development, and protocols 68 1.3.4.1. Malaria drug discovery and development 68 1.3.4.1.1. Key stages in discovery and development 69 1.3.4.1.2. Drugs under development 72 1.3.4.1.3. Artesunate, Coartem and FDA approval 74 1.3.4.2. Issues involved with local manufacture 75 1.3.5. Counterfeit and substandard drugs 76 1.3.5.1. Counterfeit atemisinins 76 1.3.5.2. Substandard artemisinins 77 1.4. The Context: Global Supply, Demand, Subsidies, and Aid 1.4.1. Technical dimensions of supply & demand 81 1.4.1.1. Global supply of Artemisia and artemisinin 81 1.4.1.1.1. Artemisia: area and yield 81 1.4.1.1.2. Artemisinin: extractors and extraction 83 1.4.1.2. Demand for artemisinin: new ACTs 84 1.4.1.3. Scientific developments and issues 86 1.4.1.3.1. Other sources of artemisinin 86 1.4.1.3.1.1. New plant sources? 86 1.4.1.3.1.2. New derivatives 87 1.4.1.3.1.3. Chemical and biological synthesis 87 1.4.1.3.1.4. Transformation of artemisinic acid 90 1.4.1.3.2. Need for a different type of drug action 92 1.4.1.3.3. Improved methods of prevention: vaccines 93 1.4.1.4. Implications for Artemisia and artemisinin 95 1.4.2. National policy and international programs 96 1.4.2.1. National adoption of ACTs 96 viii Book_inside_171012.qxd:Book 24/10/12 20:31 Page 9 CONTENTS 1.4.2.2. International subsidy programs 97 1.4.2.2.1. The Global Fund to Fight AIDS, Tuberculosis and Malaria 98 1.4.2.2.2. The Affordable Medicines Facility for Malaria (AMFm) 101 1.4.2.2.2.1. Phases in establishment 101 1.4.2.2.2.2. Participation and performance 105 1.4.2.2.3. Similar programmatic constraints 106 1.4.2.3. The World Bank Malaria Booster Program 109 1.4.2.4. Specialized global and African programs 110 1.4.3. Donor assistance and research programs 112 1.4.3.1. Agencies of the U. S. Government 112 1.4.3.2. Expansion of USAID programs 114 1.4.3.3. Other national donor programs 118 1.4.3.4. Relative contributions of major donors 119 1.5. Policy Issues: Public, Public/Private, Social, and Program 1.5.1. Public needs, public goods, and resource allocation 121 1.5.1.1. Public needs and public goods: health and malaria 121 1.5.1.2. Allocation of public resources 125 1.5.2.
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