Andreas Heddini, MD, PhD. ReAct Action on Antibiotic Resistance

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1 Andreas Heddini, MD, PhD ReAct Action on Antibiotic Resistance

2 Patients with pneumonia and bacteria in blood Penicillin Penicillin increased the chance of survival from 10% to 90% % surviing Days Untreated

3 70 years later Alarming spread of resistant infections! Everyday, health professionals are facing patients whom they cannot treat

4 Antibiotika botar bakterieinfektioner Lunginflammation Urinvägsinfektion Sårinfektion Blodförgiftning Bukinfektion Skelettinfektion Svåra diarréer Gonorré Klamydia

5 The survival of the fit

6 Tidsaxel Jorden svalnar Bakterier Miljarder år sedan

7 Tidsaxel Jorden svalnar Bakterier Cyanobacterier gör O Miljarder år sedan

8 Tidsaxel Jorden svalnar Bakterier Cyanobacterier gör O 2 Eukarytoa celler Miljarder år sedan

9 Tidsaxel Jorden svalnar Bakterier Cyanobacterier Växter gör O 2 djur Eukarytoa celler Miljarder år sedan

10 Modern medicine is built on access to effective antibiotics

11 Modern medicine is not possible without effective antibiotics Hip replacement Organ transplants Cancer chemotherapy Care of preterm babies

12 Nor is fundamental health care

13 - In the EU, patients die from selected multidrug resistant bacteria annually - These deaths results in extra health-care costs and productivity losses of at least EURO 1.5 billion per year (ReAct/ECDC/EMEA joint technical report: The bacterial challenge: time to ReAct) (Extrapolations based on Roberts et al CID 2009) - Antibiotic-resistant infections cost the U.S. healthcare system an excess of $20 billion annually - These avoidable infections result in more than $35 billion in societal costs and more than 8 million additional days spent in the hospital

5 billion per year (ReAct/ECDC/EMEA joint technical report: The bacterial challenge: time to ReAct) (Extrapolations based on Roberts et al

14 Det globala kollektiva självbedrägeriet Vi har alltför länge trott att resistensproblemet kan hanteras genom att nya antibiotika kommer finnas till hands för behandling av bakterieinfektioner Vi har inte sett antibiotikaresistens som ett dynamiskt, epidemiologiskt, ekologiskt fenomen.

till hands för behandling av bakterieinfektioner Vi har inte sett

15 To the Congress in 1969: The time has come to close the book on infectious diseases.. William H. Stewart Surgeon General

16 Back to the pre-antibiotic era! Antibiotics are losing their effectiveness at a pace that was unforeseen just 10 years ago

17 The dwindling antibiotic pipeline... Trimetoprim Sulphonamide s Quinolones Chloramphenic ol Lincosamid Tetracyclines es Aminoglycoside Penicillins s Streptogramins Macrolides Glycopeptides No new drugs for Gram-negative bacterial infections - ESBL-carrying bacteria - Typhoid fever - Shigella Lipopeptides - Gonorrhoea Oxazolidino nes 1930 s 1940 s 1950 s 1960 s 1970 s 1980 s 1990 s 2000 s

Aminoglycoside Penicillins s Streptogramins Macrolides Glycopeptides No new drugs for

18 It is not difficult to make microbes resistant to penicillin.. The time may come when penicillin can be bought by anyone in the shops. Then there is the danger that the ignorant man may easily underdose himself and by exposing his microbes to non-lethal quantities of the drug make them resistant. Alexander Fleming's Nobel Lecture, 1945

Then there is the danger that the ignorant man may easily underdose himself and by

20 Illegal OTC antibiotic sale in the EU Athens, Greece (174 pharmacies) 2008: - 100% of all visited pharmacies sold Amoxicillin/clavulanic acid OTC - 53% sold Ciprofloxacin OTC, despite extra restrictions for fluoroquinolone prescriptions Plachouras et al. Euro Surveill. 2010

Amoxicillin/clavulanic acid OTC - 53% sold Ciprofloxacin OTC,

21 ESBL (CTX-M) producing Enterobacteriaceae Endemicity Sporadic reports 2007 Endemicity Sporadic reports 2005

22 Orphanage in Bamako, Mali ESBL colonized 100% of the children and 63%, of the adult staff studied. Tandé et al. Emerg Infect Dis Mar;15(3): Mumhibili hospital, Tanzania The mortality rate from Gramnegative bloodstream infection was 43 %, more than double that of malaria.. Blomberg et al. BMC Infect Dis May 22;7:43.

23 Antibiotic susceptibility proportions for NDM-1-positive Enterobacteriaceae isolated in the UK and India UK (n=37) Chennai (n=44) Haryana (n=26) Imipenem 0% 0% 0% Meropenem 3% 3% 3% Piperacillin-taz 0% 0% 0% Cefotaxime 0% 0% 0% Ceftazidime 0% 0% 0% Cefpirome 0% 0% 0% Aztreonam 11% 0% 8% Ciprofloxacin 8% 8% 8% Gentamicin 3% 3% 3% Tobramycin 0% 0% 0% Amikacin 0% 0% 0% Minocycline 0% 0% 0% Tigecycline 64% 56% 67% Colistin 89% 94% 100% From Kumarasamy et al. Lancet Infect Dis 2010

24 Rolain et al. Clin Microb Inf 2010 Spread of NDM-1

25 The tip of the iceberg ICU Hospital Community Ecology

28 Action is needed now! People are dying from bacterial infections because the lack of effective therapy Antibiotic resistance is causing significant costs for health care The market driven system for research and development of new antibiotics is failing

29 Key strategies to stop manage antibiotic resistance Minimize irrational use of antibiotics Prevent infections and bacterial spread Development of new antibiotics and alternatives

30 Challenges for the development of new antibiotics Lack of incentives for the pharmaceutical industry Technically & biologically difficult New business model required

31 Activities during the Swedish EU presidency 2009 Innovative Incentives for Effective Antibacterials, a conference focusing on the need to develop new pharmaceuticals against infectious diseases

32 Innovation and R&D for novel antibiotics Many new initiatives targeted to address this health concern have been launched, notably in the area of R&D of new antibiotics Need for global measures that ensure that new strategies and/or health technologies are applicable, accessible and affordable also in low- and middle income countries

34 The solution: collaboration for innovation Civil society Pharm. industry DG Enterprise DG Research DG SANCO Academia New Antibiotics Regulatory agencies WHO National Govt s

35 Towards a Global surveillance system of abr?

36 Why surveillance? Underpin and update local treatment guidelines Provide better information for cost-ofillness/burden assessments Form a basis for needs-driven R&D for new antibiotics Early warning & detection of new resistance types - spread

37 Increasing attention WHD 2011 ABR has climbed international agendas Renewed interest from pharmaceutical industry implementation!

38 We know quite well what we need to do Context specific!

39 Tillsammans kan de nordiska länderna göra mer!

40 Vad behöver göras? Bildandet av en regeringsallians för att utbyta erfarenheter och stimulera andra länder att agera Tillsammans driva på utvecklingen av nya antibiotikaklasser och diagnostiska hjälpmedel Tillsammans stödja uppbyggandet av ett globalt övervakningsnätverk Gemensamt agerande i Världshälsoförsamlingen (WHA)

42 ReAct core groups and collaborators South East Asia ReAct core nodes ReAct collaborators Australia

43 ReAct Vision Current and future generations will have access to effective prevention and treatment of bacterial infections as part of their right to health

45 Antibiotic Resistance Caused by human activity and by over- consumption of global resources A failure of public policy & global governance, research prioritization and the current market system It is a collective responsibility by governments, supranational organizations and individuals to take action Nasa 1969: Earthrise over the moon from Apollo II

Drug Use Review. Edward Cox, M.D. Director Office of Antimicrobial Products

Drug Use Review. Edward Cox, M.D. Director Office of Antimicrobial Products Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation and Research Drug Use Review Date: April 5, 2012 To: Through: Edward Cox, M.D. Director