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Drug Resistance as a Global Health Policy Priority

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1 Drug Resistance as a Global Health Policy Priority
Global Ministerial Forum on Research for Health November 18, 2008 Bamako, Mali Good afternoon, thanks so much for joining us! I’m Rachel Nugent, deputy director and chair of the Center for Global Development’s Drug Resistance Working Group. The WG has been looking at the problem of global DR for about 1 year now, and we’re at a point when it’s useful to seek input from other experts. While we haven’t yet put together our full slate of recommendations, the Bamako meeting was too important to pass up as an opportunity to share some preliminary ideas, and get your feedback and guidance. We are very pleased that you are attending this session and would like to additionally invite you to participate in an open session we will hold on 20 November at the Hotel Bamako Laico el Farouk from 9:30-11:30. and during which we will share, discuss and debate our draft recommendations. Susan Foster, Martha Gyansa-Lutterodt & Rachel Nugent Drug Resistance Working Group

2 Session Objectives To communicate the evidence that drug resistance is an important global (also African) policy priority; To articulate a common solution framework based on the risk factors for resistance across treatments for HIV/AIDS, malaria, TB and other key microbial infections; To share the CGD Drug Resistance Working Group’s preliminary recommendations for the set of incentives, governance capabilities and actions, and financing mechanisms that could reduce drug resistance globally. 2

3 Session Overview Introduction to the CGD DRWG, our presenters today and brief summary of what the DRWG aims to achieve Is drug resistance currently an important global policy priority? An overview of the reasons why it should be The drug resistance problem from a West African perspective (malaria, tuberculosis, other neglected diseases) Working towards a common solution framework to address drug resistance across diseases Preliminary recommendations and conclusion Q&A I’d like to give you a brief overview of this session and our presenters. I’ll begin with a quick introduction to CGD’s DRWG. Following that, Susan Foster, who is actually a Professor of International Health (rather than economics) at Boston University in the USA. She is also the Director of Public Policy and Education for the Alliance for the Prudent Use of Antibiotics (APUA) which is a non-profit global organization seeking to contain antibiotic resistance and improve antibiotic effectiveness. Its mission is to strengthen society’s defenses against infectious disease by promoting appropriate antimicrobial access and use and controlling antimicrobial resistance on a worldwide basis. It is composed of affiliated chapters in over 60 countries, many of which are in the developing world. Our colleague, Martha Gyansa-Lutterodt will then present drug resistance in the context of West Africa. Martha is a Program Manager within the National Drugs Program in Ghana and has extensive experience in the region. Following Martha, I will describe the framework we, as a WG, are using to frame the drug resistance problem across diseases and share a few of our preliminary recommendations. After that, we will open the floor to your questions and general discussion. 3

4 Center for Global Development, the CGD’s Drug Resistance Working Group
Introduction to the Center for Global Development, the CGD’s Drug Resistance Working Group and our presenters today 4

5 About the Center for Global Development
Independent, non-partisan think tank Focus on the effects of rich-country policies on poor countries Promote policy alternatives Research Areas: Development Aid Effectiveness Global Health & Education Debt Migration Trade Climate Change 5

6 Features of CGD Working Groups
Leading experts in public health, economics and other social science and technical fields Original, focused research on high-priority global health policy / finance issues Improve the outcomes of donor decision-making in global health with: Expanded evidence-base New people and perspectives Innovative solutions/ approaches Active communication and outreach Supported with a grant from the Bill & Melinda Gates Foundation A large proportion of our work in global health is through Working Groups I want to emphasize two key features that are important in distinguishing our work: Problems that are primarily related to actions that can be taken at the global level Our work is not only about describing problems; recommendations emphasize the “how” 6

7 Working Group Timeline
Background paper Consultation draft Final report launch Initial Conceptualization Won’t go into detail about this process, except to make a couple of points: From the start, we consider how to achieve impact, and we revisit that along the entire process Careful selection of WG members to ensure appropriate expertise, but also people beyond the usual suspects, and beyond the “responsible” organizations Through a series of WG meetings, we concentrate on the “what” part of the challenge initially and work towards finding a manageable set of credible, feasible, and sustainable ideas. We’re nearing the end of that phase right now, and getting ready to embark on the official “consultation” phase where we invite input on a set of recommendations. As I said, due to the importance of the Bamako meeting, we are bringing some ideas to you that are fairly broad-brush. Before we fully establish the feasibility and sustainability of them, we’re looking to you to help us determine whether they are credible. By the time we have a report draft that the WG has endorsed as a whole (December), we will be able to talk more about the “how” of these recommendations. That issue will continue to be refined as we engage in additional consultations through early 2009, and then prepare a final report reflecting that feedback and our further analysis. When our DRWG report is launched in mid-2009, we will continue to work with different stakeholders on implementation. Working Group Meetings Stakeholder Consultations Outreach & Dissemination Problem definition Conceptual framework/summary of empirical research Identification/invitation of working group members Development of timeline Outline of outreach strategy and goals for policy impact In-depth topic exploration Targeted analyses Analysis of potential solutions Proposed policy recommendations Staff draft distributed for feedback from broad set of stakeholders Considered by WG & reflected in revised product Materials developed for specific audiences Briefs, journal articles, etc. Large & small events Policy Impact 7

8 DRWG Statement of Purpose
The Drug Resistance Working Group will generate critical thinking about: Magnitude and nature of emergence and spread of drug resistance Differences across diseases and regions Implications of drug resistance for multiple stakeholders Specific actions and investments by international actors to create a systematic response to resistance Resulting in analytically-based policy recommendations for: Multi- and bilateral funders Technical agencies Policymakers in developing countries 8

9 global public health policy priority
Drug Resistance as an important global public health policy priority 9

10 Impacts of drug resistance
Resistance limits the effective useful lifespan of drugs Makes industry less interested in research and development Older antibiotics to treat common infectious diseases are often more toxic e.g. chloramphenicol and gentamicin, or more expensive e.g. amoxiclav, or both Treatment options become more limited Higher 2nd and 3rd line treatment costs Some conditions become untreatable – XDR-TB, MRSA, will cholera and shigella be next? 10

11 Why is drug resistance a global public health policy priority?
Resistance causes avoidable mortality and morbidity, undermining renewed global health efforts Resistance occurs across major infectious diseases Drug use for one condition affects resistance for other conditions, e.g. cotrimoxazole for HIV affects use for ARI Resistance means spending more on drugs to get the same effect, in an era of extreme competition for health budgets Resistance knows no barriers and requires international coordination to control In both Uganda and Zambia, DHS surveys have reported that over two-thirds of children with symptoms of ARI are taken to a health facility… …yet ARI still caused 21% and 22% of mortality of children under 5 in those countries respectively 11

12 Incentives to slow resistance are lacking
Divergence between private and social interests and incentives As a parent, I want to treat my child with antibiotics - I am not concerned about the common good! Drug efficacy is a diminishing resource – a public good, shared by all Yet there is no mechanism for control or rationing of this resource (no OPEC of antibiotics!) Most incentives are for more, not less, use A transnational issue – crosses borders and regions, but no control body (or even tracking body) Resistance which develops in one area soon spreads Tension between preventive and therapeutic AB use Pharmaceutical industry incentives are mixed 12

13 The supply of new antibiotics is drying up
Zero? Total number of new antibacterial agents introduced 13

14 Newer antibiotics are more expensive
Amoxicillin and clavulanic acid is 20 times more expensive than ampicillin The change in standard therapy for malaria from chloroquine (CQ) and sulfadoxine/pyrimethamine (SP) to artemisinin containing therapy (ACT) has increased the cost of treating a case of malaria by a factor of 10 or more It costs up to 500 times as much to treat drug-resistant TB compared to standard TB 14

15 Drug prices compared Drug Price/ unit Units/ dose Price/dose
Amoxicillin 250 mg tab/cap $0.02 28 $0.43 Amoxicillin/clavulanic acid $0.30 $8.40 Ampicillin 250 mg tab/cap $0.01 $0.41 Azithromycin 250 mg tab/cap $0.22 6 $1.31 Chloramphenicol 250 mg tab/cap $0.39 Ciprofloxacin 250 mg tab/cap 56 $1.09 Cotrimoxazole (b) mg tab/cap $0.47 Doxycycline 100 mg tab/cap 11 $0.11 Erythromycin 250 mg tab/cap $0.03 40 $1.05 Penicillin V 250 mg tab/cap $0.71 Tetracycline 250 mg tab/cap 36 $0.27 15

16 The cost of poor diagnosis
Much of the expenditure on drugs is wasted because they are not appropriate or indicated for the patient’s condition Antibiotics may be given for acute respiratory infections which are viral in origin, or antimalarials given for pneumonia: young, febrile children are often treated empirically for malaria, when in fact they have pneumonia (Kallander, Nsungwa-Sabiiti et al. 2004) Antibiotics continue to be used where resistance is already very high Stress the issue around malaria / pneumonia – a major area to make improvement, especially now that ACT is widespread and rapid diagnostic tests are also available 16

17 Friend or foe? Source: MMV
Resistance increases as drug access improves and urbanization increases (more informal sector options?) The rise and expansion of the informal sector (a part of urbanization?) is a threat to good antibiotic use – but also an opportunity to extend the availability of treatment to a wider group of the population, especially the low income groups. These drug sellers are in some cases very interested in training on proper use of the drugs they sell. Over 20 informal sector drug outlets along a 2 km stretch of road in a new urban settlement in East Africa Source: MMV 17

18 Drug Resistance: a global snapshot 18 18

19 Ciprofloxacin resistance increasing
Consistent increase in the median MIC* of V. cholerae O1 strains isolated at the Dhaka Hospital: 0.003 μg/mL in 1994 0.023 μg/mL in 2001 0.38 to 0.5 μg/mL in 2005 Source: A.S.G. Faruque, J HEALTH POPUL NUTR Jun;25(2): MIC, minimum inhibitory concentration, is the minimum concentration of antibiotic which will inhibit the growth of the isolated microorganism Note that the rise in MIC for cipro for cholera rose more than 100 fold in just ten years! 19

20 Multidrug resistance in S. pneumoniae
In Asia a very high % of S. pneumoniae isolates collected during were multi-drug resistant (to penicillin, erythromycin and ciprofloxacin) (Song et al, 2004) % resistant 20

21 Multidrug resistant cholera in Bangladesh is rapidly rising – over 7 months!
Note that the scale of this rapid rise is 7 or 8 MONTHS, not years! Strains resistant to furazolidone, trimethoprim/sulphamethoxazole, tetracycline, and erythromycin Source: A.S.G. Faruque, J HEALTH POPUL NUTR 2007 Jun;25(2): 21

22 The current situation HIV/AIDS – lots of activity: lifelong therapy, industrialized market Main issue is price Malaria – after artemisinin, le déluge? Tuberculosis – much too little attention given the size of the problem! Industry not very interested, relying on PPPs Bacterial infections – many pathogens, short duration of therapy (7-10 d), complex Companies just not interested in this field! Need to use what we have as well as possible 22

23 A strategy for antibiotics – to use the little we have
Much (perhaps most?) outpatient antibiotic use is for children, maternal, and adults with HIV Specifically for a few conditions: Pneumonia and ARI Diarrheal disease (often inappropriate) Infections Earache, throat Wounds and skin infections Tuberculosis (both children and adults, esp. w/ HIV) Maternal infections and sepsis If we get these right, major progress could be made 23

24 a West African snapshot
Drug Resistance: a West African snapshot 24

25 Political map of West Africa

26 Drug resistance challenges: selected findings on malaria
Chloroquine and sulphadoxine/pyrimethamine resistance has been reported throughout West Africa (Spencer et al 1986, Amukoye et al 1997, and in Ghana (Neequaye 1986, Koram et al, 2005) Led to change in treatment policy of ACTs across the sub region IMPACT Huge resource allocation Monotherapies still available Substandard /counterfeit ACTs still circulating in the regional markets (Minzi et al,2003, Amin et al, 2005, Bates et al, 2008) 26

27 Resistance of P. falciparum around the world: when to switch to ACT?

28 Drug resistance challenges: selected findings on TB and neglected diseases
Mycobacterium tuberculosis drug resistant to at least streptomycin, isoniazid and rifampin has been reported (van der Werf TS et al 1989, Lawn et al 2001, and Owusu- Dabo et al, 2006) New medicines for TB slow to emerge Situation exacerbated by HIV/AIDs co-infection Onchocerciasis worms non-responsive to ivermectin have been reported with an increase in the rate of re- population by adult worms (Osei-Antweneboana et al, 2007) Data on other neglected diseases is limited For example, concern has been raised about schistosomiasis and resistance to praziquantel… 28

29 In short: Drug resistance is not limited to the developed world; indeed it is present in Sub-Saharan Africa with grave consequences The drivers of resistance are well known and very challenging for West Africa, stemming primarily from Weak health systems Behavioral issues – including, but also going beyond, those behaviors resulting from low literacy and high poverty levels Drug and diagnostics technologies – limited research in Africa It is clear that a global framework for action is required 29

30 common solution framework and a snapshot of potential recommendations
Towards a common solution framework and a snapshot of potential recommendations 30

31 Common solution framework to address resistance across diseases
Drug Technology Factors Health Systems Factors Poor quality, unregulated prescribing/dispensing, weak infection control, lack of rapid diagnostic tools, poor surveillance long drug half-life, cross-resistance, treatment length and complexity, monotherapy Resistance (Patient): poor adherence, self-medication, cultural preferences/beliefs (Provider):unclear diagnosis, financial incentives, industry promotion 31 Behavioral Factors

32 Common health system factors that drive resistance across diseases
Key “health system” drivers include: Paucity or poor quality of resistance surveillance efforts Lack of connection between resistance situation and drug selection/procurement Lack of high-quality rapid diagnostic and monitoring tests and algorithms Lack of or poor quality services Lack of education and training among dispensers accompanied by poor monitoring and enforcement Lack of or weak implementation of infection control policies Direct/indirect costs of accessing services: one possible cause of poor adherence Lack of/poor implementation of regulations governing prescribing and dispensing Under and over-prescription of (usually broad-spectrum) antibiotics, when not clear pathogen is viral or bacterial = inappropriate drug use Lack of or poor quality services: Health service infrastructure, but also other inputs such as HR (unavailable, unmotivated, overworked) and drugs/supplies/diagnostic tests etc. (unavailable due to supply chain issues or leakage) Direct and indirect costs of accessing services: Especially for chronic treatments (but also evidence for acute). Direct costs for drugs and/or appointment and transport. Indirect costs of time off work. Evidence of patients returning once treatment became free of charge Lack of education and training among dispensers accompanied by poor monitoring and enforcement Global estimates suggest that over 50% of antibiotics are dispensed without a prescription, often by informal providers who have little to no training (WHO/EMRO, 2002) Lack of or weak implementation of infection control policies Evidence from Estonian, Russian and Georgian hospitals and prisons shows how poor infection control measures have led to high rates of MDR-TB transmission among patients, staff and inmates (Ruddy et al (2005), Kruuner et al (2001) and Aerts et al (2000)) Additionally, rural South Africa’s recent MDR-TB and XDR-TB outbreak suggests that both nosocomial and community transmission of MDR-TB and XDR-TB took place, the former driven by the terribly weak infection control measures (Gandhi et al, 2006) Lack of high-quality rapid diagnostic and monitoring tests and algorithms: This can result in health providers tending to recommend that treatment be started at a low threshold (particularly for malaria) = inappropriate drug use Over-prescription of (usually broad-spectrum) antibiotics, when not clear if pathogen is viral or bacterial = inappropriate drug use HIV viral load testing (a proxy for adherence) is a glaring gap in developing countries Paucity or poor quality of resistance surveillance efforts But good news is that several efforts being made to change this (Stop TB/IUATLD efforts since 1994; HIVDR Global Laboratory Strategy etc.) – is this enough or does the world urgently need more? 32

33 Common behavioral factors that drive resistance across diseases
Factors motivating or demotivating patients: Poor quality/lack of services Health worker attitudes Drug and supply availability and access Direct and indirect costs Community and/or family-level disease associated stigma Cultural preferences/beliefs Gender-related issues Factors motivating or demotivating behaviors during the patient-provider interaction: Providers often assume that a patient desires a drug (which, indeed, often is the case) and, therefore, choose to “satisfy the customer  leads to better relationship and more chance patient will return Prescribing a drug also provides a psychological signal that the consultation is over; a transaction has taken place whereby the patient has received something tangible for his or her (direct and indirect) costs Industry may play a role in influencing this interaction. Direct to consumer advertizing may make the consumer feel he/she has some knowledge about the drug product and may prompt/empower him or her to suggest the particular drug to the provider 33

34 Common behavioral factors that drive resistance across diseases (2)
Factors motivating or demotivating providers: Who gains where financially along the patient-prescriber-dispenser (possible drug) transaction Poor quality/lack of diagnostic tests can lead to over-prescription Evidence that providers may not trust negative diagnostic result Cultural preferences/beliefs and gender-related issues Pharmaceutical industry efforts to influence prescribing behavior And there are also factors that motivate or demotivate behaviors during the patient-provider interaction Factors motivating or demotivating behaviors during the patient-provider interaction: Providers often assume that a patient desires a drug (which, indeed, often is the case) and, therefore, choose to “satisfy the customer  leads to better relationship and more chance patient will return Prescribing a drug also provides a psychological signal that the consultation is over; a transaction has taken place whereby the patient has received something tangible for his or her (direct and indirect) costs Industry may play a role in influencing this interaction. Direct to consumer advertizing may make the consumer feel he/she has some knowledge about the drug product and may prompt/empower him or her to suggest the particular drug to the provider 34

35 Common drug and drug technology factors that drive resistance
Key “drug and drug technology” drivers include: Drug half-life Monotherapy favors acquired resistance; combination therapies are challenging to formulate What possibility is there that the pathogen will “become” re-sensitive to a given drug? Cross-resistance across and within drug classes Length and complexity of treatment: impact on adherence and resistance selection pressure Absolute levels of drug use, fitness and virulence What alternatives might there be to using drugs? Drug half-life Adherence is less of a challenge if the drug has a long half-life, but long half-life favors resistance (ex: SP, ACTs) Monotherapy favors acquired resistance Fixed-drug combinations (FDCs) can be an effective “resistance-slowing” tool (ex: TB, HAART and, increasingly, malaria) Cross-resistance across and within drug classes NNRTIs and antimicrobials to treat Shigella Length and complexity of treatment: impact on adherence and resistance selection pressure Especially in the case of TB and HIV Absolute levels of drug use, fitness and virulence Evidence that increasing use of antibiotics/antimalarials facilitates selection of resistant strains is less strong in developing than developed countries, due to a lack of data on antibiotic use (Laxminarayan, R. et al. 2006) What possibility is there that pathogen will “re-become” sensitive to a given drug? CQ cycling evidence from Malawi; V Cholera has ability as well but it is highly unlikely for Shigella What alternatives might there be to using drugs? S. pneumoniae conjugate pneumococcal vaccine, TB, HIV and malaria vaccines 35

36 Comparison of Disease-Related Resistance Issues
(adapted from the 2001 WHO Global Strategy for Containment of Antimicrobial Resistance) Issues Bacterial Infections TB Malaria HIV Inappropriate Use Contributes to ↑ Drug Resistance Yes Need for New Drug Development Detection of Pathogen Reasonably Easy and Feasible Easy Detection of in vitro resistance Feasible but Expensive Difficult, Expensive, Rarely Feasible Difficult, Expensive, Limited Availability Diagnostics Able to Detect Resistance Yes, but slow Some No Yes, but expensive and with limited availability Observed Treatment Yes  DOTS Antimicrobial Treatment Single Agent, Short Duration Multiple Agents, Long Duration ≥1 Agent, Short Duration Multiple Agents, Lifelong HIV Interaction Some: Especially Nosocomial Risk Massive: Personal & Nosocomial Risk Possibly N/A Potential Impact of One Program on Another Yes; Some Antibiotics Could Affect Malaria Resistance Little; Except for Rifampicin Use on Staph. Spp. Some; e.g. doxycyline, sulphadoxine-pyrimethamine Yes; e.g. cotrimoxazole + isoniazid prophylaxis ONE OF OUR KEY UNDERLYING ASSUMPTIONS IS THE VALUE OF A CROSS DISEASE APPROACH; SO WE ARE IDENTIFYING COMMONALITIES, WHILE RESPECTING IMPORTANT VARIATION ACROSS THE RESISTANCE EXPERIENCES THIS TABLE ILLUSTRATES A RANGE OF COMMONALITIES IDENTIFIED BY WHO. WE ARE BUILDING ON IT TO SHOW OUR OWN SET OF CHARACTERISTICS, ESPECIALLY RELATED TO INCENTIVE ISSUES, AND DEMONSTRATE KEY COMMONALITIES AND DIFFERENCES. FROM THESE, WE CAN SHOW WHERE CROSS-DISEASE ACTIONS ARE CALLED FOR AND WHERE THEY AREN’T MOVING QUICKLY DOWN THE ROWS, SEE SEVERAL THAT PERTAIN TO PATIENT AND PROVIDER BEHAVIOR, THEN TECHNOLOGY, THEN TREATMENT (INCLUDED IN THE HEALTH SYSTEMS CATEGORY FROM OUR TRIPARTITE FRAMEWORK) WE’LL USE THESE CHARACTERISTICS TO MOTIVATE THE RECOMMENDATIONS . NOTE THAT TODAY I WILL DISCUSS ONLY A PORTION OF THE PRELIMINARY RECS WE ARE WORKING ON. WE’RE TRYING TO IDENTIFY WHERE COLLECTIVE ACTION MIGHT PRODUCE COMMON BENEFITS, SUCH AS ECONOMIES OF SCALE OR DESIRABLE HERD BEHAVIOR

37 Snapshot of potential DRWG recommendations
Health Systems: Establish cross-disease laboratory systems based on molecular technologies Build on WHONET to insert resistance into public health surveillance systems Add resistance to HealthMap and other informal surveillance systems Scale up ADDO/similar approaches to franchise or certify dispensers Proliferation of GMP  Industry self-regulation for QA (e.g. ISO) Continuing professional education; the role of professional assns. and drug reps Behavioral: Cross-country drug regulatory networks (ex. WADRAN) Drug dispenser checklist (potential to work with FIP) Options to improve consumer education Technology: Public, web-based compound library showcase to accelerate early-stage product development Other: Health and Development Conference on Resistance WHO’s GLI: To maximize the activities of the SLCS and the SRLN, and optimize the network of Stop TB partners involved in laboratory strengthening, a Global Laboratory Initiative (GLI) was proposed to and endorsed by the STP Coordinating Board in October The GLI provides a focus for TB within the framework of a multi-faceted yet integrated approach to laboratory capacity strengthening through a network of partners. The GLI Secretariat is hosted in the Stop TB Department at the World Health Organization (WHO) in Geneva, Switzerland and works closely with National TB Programmes, nongovernmental organizations, technical and financial partners, and WHO offices at country and regional levels, in strengthening TB laboratory services. Components of the GLI include: Global policy guidance on appropriate laboratory technology and best practices, Laboratory advocacy and resource mobilization, Laboratory capacity development and coordination, Interface design with other laboratory networks to ensure appropriate integration, Standardized laboratory quality assurance, Coordination of technical assistance and Effective knowledge sharing WB just announced a similar laboratory initiative, but not disease-specific, last month at the Union meeting MSH’s ADDO program: A systematic and holistic approach to the problems of DLDBs was used to develop the Accredited Drug Dispensing Outlets (ADDO) program during the pilot program under the Strategies for Enhancing Access to Medicines (SEAM) Program funded by the Bill & Melinda Gates Foundation in 2000.  The goal of the ADDO program was to increase access to essential medicines through utilization of the private sector. All aspects of the DLDB enterprise—including the physical premises, stock maintained by the owner, consumer choices, interactions with dispensers, and recommended treatments—had to be improved. In addition, the larger systems in which DLDBs are embedded, which include licensing, supply, training, and inspection, involving ward, district, regional, and national authorities, also had to be changed and strengthened. After gaining support from key stakeholders, TFDA and the government of the region of Ruvuma, in collaboration with MSH, implemented the pilot ADDO initiative in Quality of both products and services was ensured through a combination of government accreditation and regulation mediated through routine monitoring by district/local government and community structures. Accreditation as applied to the ADDO program aims to improve the availability of essential medicines and the quality of services by working with independent shop owners and dispensing staff via provision of education, training and supervision; commercial incentives combined with decentralized regulatory oversight.  Accreditation is granted on achievement and maintenance of a set of pre-established standards. 37

38 Conclusion Next steps Last working group meeting in early December to solidify recommendations Continue consultation sessions through to end January 2009 Launch WG report in April/May Outreach and dissemination  IMPACT We need your thoughts: how to have input Please attend our open session on 20 November here in Bamako (Hotel Laico el Farouk 9:30-11:30, Room Kafo) to give input on our preliminary recommendations Sign up for Monthly CGD Drug Resistance e-newsletter Once the draft report with preliminary recommendations is ready, we will post it to our website and let those of you who subscribe to the e-newsletter where it is, so you can provide input. 38

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