Call for Malaria ACTs appraisal


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Recent literature review of Artemisinin based Combination therapy reveals that current WHO guidelines on Malaria do not reach publication standards thus are subject to caution. StratAdviser, thanks to its expertise in Strategic Knowledge Management and Interantional expert Board Management call for the creation of a literature review board and welcome any sponsor and participant to contact us.

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Call for Malaria ACTs appraisal

  1. 1. Literature Review on Current and Future Artemisinin-basedCombination Therapy: Recent Trends Dr. Jan-Cedric Hansen Medico-Marketing European Strategist StratAdviserLtd Medical Coordinator at Hopital Asselin-Hedelin France
  2. 2. China and ArtemisininKnown by traditional Chinese Medicine– since 4th CenturyExtracted from “Chinese Absinth”Key Role of Chinese Researcher Tu Youyou– 1971 design of a optimal extraction protocol– 1972 identification of Artemisinin– 1979 publication in English of first results with Artemisinin derivatives 5-Nov-11 IDDST 2011 – StratAdviser Ltd 2
  3. 3. Situational Analysis16 deaths every 10 min worldwideWHO’s guidelines for the treatment of malaria– Evidence-based recommendations– Clear diagnosis criteria– Safe and effective antimalarial medicines selection– Therapeutic strategy for given clinical situations– Referencing point for malaria control programs Recognition that artemisinin-based combination therapies (ACTs): 1) increase the rates of clinical and parasitological cures 2) decrease the selection pressure (less resistance risk) 5-Nov-11 IDDST 2011 – StratAdviser Ltd 3
  4. 4. Limitation of WHO’s guidelines* The 2010 second edition literature overview is – Limited to June 2004 • with the exception of 47 publications released between 2004 and mid 2008 – Promotes Artemether vs Artesunate • despite no evidence that Artemisinin derivatives differ • rather than comparing the partner medicines’ influence – Whilst neglecting nearly 400 papers released on • “malaria, falciparum/drug therapy” & "artemisinins/therapeutic use“* As a recognised Strategic Knowledge Management advisor, StratAdviser has been granted by Sanofi to appraise “WHO’s guidelines for thetreatment of malaria 2nd edition” in an independent manner in order to determine whether there was a bias regarding the fact that the reportopposes Artemether to Artesunate. In order to achieve its assignment, StratAdviser followed a rigorous proprietary methodology. 5-Nov-11 IDDST 2011 – StratAdviser Ltd 4
  5. 5. Literature reviewMore complex than expected 5-Nov-11 IDDST 2011 – StratAdviser Ltd 5
  6. 6. MethodologyArtemisinin Medline Search Strategy– Restriction to past 5 years (relevance)– 2,427 publications on Malaria Drug Therapy between 2006/10 and 2011/10 • 1,421 related to Artemisinin • 729 dedicated to Artemisinin Malaria Drug Therapy • 223 clinical trials (163 full access online)* "malaria/drug therapy"[MeSH Terms] AND "artemisinins"[MeSH Terms] AND (Clinical Trial[ptyp] AND "2006/10/18"[PDat] :"2011/10/16"[PDat]) 5-Nov-11 IDDST 2011 – StratAdviser Ltd 6
  7. 7. Covered TopicsDiagnostic criteria impact on therapeutic success – RDT, microscopy (Dr vs HW), ...Enhanced efficacy strategy – ACT vs ACT, ACT vs others, blood concentration monitoring, adjunctive treatment, galenic form, pre-referal treatment, ...Enhanced tolerance strategy – Intermittent, ACT vs ACT,Compliance solutions – Mobile phone alert, ...Administration route – IV, IR, PO, ...Pharmacology within different population – infant, pregnant, genetic (CP450, G6PD) , ethnic, ...Delivery model impact – Retail, health workers, ...Public health impact – Curative, preventive, selection pressure, Cost-effectiveness, ... 5-Nov-11 IDDST 2011 – StratAdviser Ltd 7
  8. 8. Homogeneity of published dataDifferent– Methodology • Double blind, Open label, Cohort, Retrospective, Meta Analysis, ...– Population • South America, Western Africa, Eastern Africa, Asia, Oceania, ...– Clinical situations • Severe, uncomplicated, age groups, ...– Treatment strategy • Dosage, Titration, Regimen, ...– Efficacy Criteria • Clinical improvement, gametocyte clearance, relapse, ... 5-Nov-11 IDDST 2011 – StratAdviser Ltd 8
  9. 9. Data Handling The abundant available literature on Artemisinin derivatives and partner medicines – Overcomes individual prescribers (field practitioners) capacity of integration – Deserves an international consensus regarding • Both confidence & relevance of available data • Both respective indications & related therapeutic strategy • Both therapeutic success & therapeutic failure indicatorsThe vast amount of information regarding ACTs make it mandatory to clarify where, to whom, when and how to prescribe This can only be achieved by an Independent International Expert Group 5-Nov-11 IDDST 2011 – StratAdviser Ltd 9
  10. 10. Call for an international independent expert groupMalaria Control Task Force 5-Nov-11 IDDST 2011 – StratAdviser Ltd 10
  11. 11. Malaria Control Task Force OverviewIt is a Therapeutic Strategy Awareness Program dedicated tothe ACTs’ Malaria Control – clarifies the ACTs’ Malaria Control rational and its related therapeutic strategy because ACTs are clearly the current gold standardIts objective is to help field practitioners – To understand better the proper use of ACTs – Thanks to a non product specific, accredited education programsIt would be an academic program – Elicited by its Co-Chairs – Potentially run by StratAdviserLtd – Funded by Third PartiesIt would be supported by an associative organisation – “Loi 1901” if housed in France – “Unincorporated Association” if housed in the UK 5-Nov-11 IDDST 2011 – StratAdviser Ltd 11
  12. 12. Malaria Control Task Force Organisation Co-Chairs are 3 key Malaria High Profile KOL who want to promote CRS as a key issue Board Members are 10 to 12 Malaria KOL who are recognised by their peers Co-Chairs regarding Clinical and/or susceptibility determine topics & questions and/or Pharmacology... (each specialty being involved in a way or another Board Members regarding Malaria Control) elaborate content Supporters are numerous Field & advocate Malaria Control Practitioners who are interested in Supporters upgrading their practice skills regarding disseminate Malaria Control (early adopter profile) – Malaria Control they are organised as “clubs” in each messages countries. They will be invited to register to Followers a CME programme to become “Malaria adhere to Malaria Control experts” Control messages Followers are other KOL, Field Stakeholders Practitioners and Healthcare Authorities Representatives that pay attention and then adhere to the Malaria Control “package” thanks to the noise generated by the above mentioned ones Stakeholders include all of the above plus sponsors, governments, patient associations, third parties... 5-Nov-11 IDDST 2011 – StratAdviser Ltd 12
  13. 13. Malaria Control Task Force MethodologyBoard members meet once a year– They have one to two video conferences per yearThey liaise in a monthly basis– Together in order to produce and/or validate the scientific/educational/informative production of the group– With Supporters to disseminate their OutputThey designate speakers– to advocate Malaria Control Task Force outputs during congresses and conferences 5-Nov-11 IDDST 2011 – StratAdviser Ltd 13
  14. 14. Malaria Control Task Force Outputs Grading of available literature and guidelines – EBM approach (AGREE, GRADE, Proprietary ...) Classification of Malaria Clinical Presentation – Severity Score, ... Proposition of relevant therapeutic strategy – 1st, 2nd, 3rd line treatment .... Identification of adequate QA indicators – Artemisinin Resistance Containment ...The clarification of the responsible use of ACTs calls for a sustained and robust dissemination program to ensure field prescribers adhesion 5-Nov-11 IDDST 2011 – StratAdviser Ltd 14
  15. 15. Malaria Control Task Force ToolsMedia Releases – written or recorded supports providing stakeholders, via media, with an information subsidy containing the basics needed to develop a news story regarding Malaria Control Task Force such as scheduled upcoming events, Board Members promotions, awards, new educational services, accomplishments, etc.Flyers – recto-verso folded supports to advertise the existence of Malaria Control Task Force, invite to a CME session, a Malaria Control seminar, to register to a Malaria Control mailing list, to visit a given website, ...Pamphlets – 8 to 16 stitched supports to disseminate interviews of Malaria Control Task Force board members and short messages links to Malaria ControlReprints – duplex supports to allow disseminating original articles with Malaria Control Task Force board members comments printed over the folder – original articles are selected by board members due to their interest regarding Malaria ControlCongress Abstracts – “400 to 600” words supports to advocate and disseminate Malaria Control Task Force Therapeutic Strategy backup, grading scale, guidelines, and related topicsCRS satellite symposia – Malaria Control Task Force Board Members are welcome to perform lectures regarding ACTs’ Therapeutic Strategy whenever they are invited to national and international congresses – sponsor may as well organise satellite symposia dedicated to ACTsCME programs – printed or dematerialized supports to allow appropriation of ACTs’ Therapeutic Strategy managementNewsletter – printed or dematerialized supports to duplicate any of the above to maximize the chances to influence the target audience 5-Nov-11 IDDST 2011 – StratAdviser Ltd 15
  16. 16. ACTs and their environmentFuture Trends and Breakthrough 5-Nov-11 IDDST 2011 – StratAdviser Ltd 16
  17. 17. 2010/2011 Proposed ShortlistNovartis Institute for Tropical Diseases (NITD), Swiss Tropical &Public Health Institute and Scripps Research Institutediscovery of a next generation treatment for drug resistantmalariaWHO/Roll Back Malaria 2011 Global Plan for ArtemisininResistance Containment (GPARC)AstraZeneca and Medicines for Malaria Venture (MMV)collaborative agreement to identify novel candidate drugs forthe treatment of malaria.Sanofi and Medicines for Malaria Venture (MMV) allianceagreement to research malaria treatmentsInstitute for OneWorldHealth, University of California, Berkeley,Amyris, and Sanofi semisynthetic (Microbially Derived)Artemisinin ProjectGSK malaria vaccine Phase III published results 5-Nov-11 IDDST 2011 – StratAdviser Ltd 17
  18. 18. Thank You Dr. Jan-Cedric Hansen Medico-Marketing European Strategist StratAdviserLtdMedical Coordinator at Hopital Asselin-Hedelin France