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Swine flu story

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  1. Swine flu story Mikko Pohjola, THL

  2. Contents • Introductory overview • Step by step walk-through of the case • Swine flu (AH1N1 influenza) • Beginning of the pandemic • Preparedness in Finland • Vaccination campaign • Public doubts • THL-GSK connections? Exaggerated risk? Vaccine efficacy? Counter-campaigning • Narcolepsy cases • Public discussions vs. experts • Halting of vaccination campaign • Pandemrix vs. narcolepsy elsewhere? • THL narcolepsy study • Publication of results and apologies • Public rage • Sacking of the guilty? Vaccine testing? Actions of S&H Ministry, THL, doctors?, Spoiled vaccine batche(es)? • EMA statement on connections between Pandemrix and narcolepsy • Re-occurence of swine flu and new vaccinations • Further vaccine/narcolepsy studies in Finland and elsewhere

  3. Introductory overview • Swine flu vaccinations and narcolepsy in Finland • Effects and side-effects? • Vaccination campaign vs. threat? • Big thanks to Otto Hänninen, THL • Many of the slides are translations from his recent presentation on the topic in Finnish

  4. The threat in summer 2009 ca. 100 nm • mortality 0,6% of those infected • Infects 5-15% of poulation http://fi.wikipedia.org/wiki/Vuoden_2009_sikainfluenssapandemia • I.e. ca. 500.000 with swine flu (according to10%) and 3.000 deaths

  5. 2009 4 5 6 Global situation 2009 WHO pandemic-alert: 4 - 27.4.2009 5 - 29.5.2009 6 - 11.6.2009 (6 is the highest alert level)


  6. Narcolepsy incidence in Finland

  7. Age-stratified narcolepsy incidence in Finland

  8. Narcolepsy (ICD-10 G47.4) • Wikipedia: • a chronicsleep disorder, or dyssomnia, characterized by excessive daytime sleepiness (EDS) in which a person experiences extreme fatigue and possibly falls asleep at inappropriate times, such as while at work or at school. • Another problem that some narcoleptics experience is cataplexy, a sudden muscular weakness brought on by strong emotions (though many people experience cataplexy without having an emotional trigger). • ”numbness attack”

  9. Narcolepsy • International background incidence in whole population 0.05% (1/2000), in Finland 0,026% (1/4000) • Normally ca. 60 incidences/year in Finland • Genetic factors important, but no deterministic inheritability • Some possible triggers: infections (streptococcus, virus), allergic reactions, autoimmune diseases, brain damage, hypothyreosis, psychological traumas

  10. A committee was set on 13.10.2010 to study the possible connection between Pandemrix vaccine and narcolepsy • Asiantuntijat, Suomen unitutkimusseura ja Suomen Lastenneurologiyhdistys suosittelijoina: • LT Päivi Olsén, Oulun yliopistollisen sairaalan lastenneurologian yksiköstä, • dosentti Christer Hublin, Työterveyslaitoksen Aivot ja työ tutkimuskeskuksesta, • dosentti Sari-Leena Himanen, Päijät-Hämeen sairaanhoitopiirin Kliinisen neurofysiologian yksiköstä, • dosentti Turkka Kirjavainen Helsingin yliopistollisen keskussairaalan Naisten- ja lastentautien tulosyksiköstä, • dosentti Markku Partinen Helsingin uniklinikalta ja • lääketieteen tohtori Outi Saarenpää-Heikkilä Tampereen yliopistollisen sairaalan lastenneurologian yksiköstä. • Sosiaali- ja terveysministeriön edustajana ryhmässä toimi lääkintöneuvos Merja Saarinen 31.12.2010 asti. • THL • dosentti Terhi Kilven THL:n Rokotusten ja immuunisuojan osastolta, • lääketieteen tohtori Hanna Nohynekin THL:n Rokotusohjelmayksiköstä • filosofian tohtori Jukka Jokisen THL:n Rokotetutkimusyksiköstä, • tutkimusprofessori Ilkka Julkusen THL:n Virusinfektioyksiköstä • tutkimusprofessori Outi Vaaralan THL:n Immuunivasteyksiköstä. www.thl.fi > sikainfluenssa http://www.thl.fi/thl-client/pdfs/f890b9f3-9922-4efe-889b-157fe2e03aa4

  11. Narcolepsy cases 2010 • 33 females, 24 males, in total 57 patients • Average age 12 years, median 11 years, range 4-37 years • 3 cases above 19 years of age • Symptoms appeared on average 52 days (0 days -8 months) after swine flu vaccination

  12. Narcolepsy in other countries Iceland: icreased narcolepsy incidence also among non-vaccinated

  13. Epidemiology • Retrospective cohort study • Follow-up (mainly) 1.1.2009-16.8.2010 • (publicity and potential diagnose sensitivity) • Incidences in age group 4-19 years / follow-up time • 9.2 fold risk (95% CI 4.5 - 21.4)

  14. Swine flu vaccines • Three vaccine groups • Split virus containing vaccines (80M vaccinated, 29M of them children) • Whole virus containing vaccines • Adjuvant containing vaccines • Pandemrix: Nordic countries, Great Britain, Ireland, Germany, France, the Netherlands, and Spain • Focetria: mainly in Italy, the Netherlands, and Greece • GlaxoSmithKline’s Arepanrix (used in Canada) has exactly same composition as Pandemrix

  15. Pandemrix side-effects (NIPH, Norway) • Normal side-effects in 1 out of 10 of those vaccinated (10%) • · Headache • · Tiredness • · Pain, redness, swelling, or hardness around the injection area • · Fever • · Pain in muscles or joints. • Other common side-effects in 1-10 out of every 100 vaccinated (1-10%) • · Heat, itching, or bruises around the injection area • · Increased sweating, shaking, flu-like symptoms • · Swollen lymph-nodes in the neck, armpit, or groin • Less common side-effects in 1-10 of every 1,000 vaccinated (>1‰) • · Tingling or numbness in the hands or feet • · Drowsiness • · Dizziness • · Diarrhoea, vomiting, stomach pains, or nausea • · Itching or a rash • · Feeling generally unwell • · Sleeplessness

  16. Vaccine batches • 28 production batches to Finland, in total 5.286.000 dosages • Vaccines from nine different batches used for those who came down with narcolepsy within the age range 5-19 years • Over 500.000 5-19 year olds vaccinated with vaccines from these batches • Some vaccines to both Finland and Sweden from same batches; distribution of narcolepsy cases does not indicate batch specificity

  17. Vaccination campaign in Finland • Aim: prevention of deaths and severe swine flu cases • Vaccination order: 1. Infection patients, personnel treating infection patients and service personnel in pharmacies 2. Pregnant women 3. Risk groups (6 months – 64 years of age) (sydänsairaus tai keuhkosairaus, aineenvaihduntasairaus, krooninen maksan tai munuaisten vajaatoiminta, vastustuskykyä heikentävä tauti tai hoito, krooninen neurologinen sairaus tai hermolihastauti) 4. Healthy children of age 6-35 months 5. Healthy children and young people of age 3-24 years, and those currently in military service 6. Risk groups of age 65 years and older 7. Others

  18. Vaccinations

  19. Swine flu cases in Finland 2009-2010 • In total 7669 pandemic influenza A(H1N1) 2009 –virus induced infections confirmed between 10.5.2009−8.3.2010. • 44 deaths • median 56 years (1-88 years) • 4 children • 26 men • 40 with a primary disease • 3 vaccinated (1 child)

  20. Vaccine efficacy? • Did the vaccination campaign subdue the epidemic or was it already subsiding by itself? • Herd immunity?

  21. Side effects of vaccination campaigns • Polio vaccination campaign in 1985 (94% of whole population of Finland) • 9 children diagnozed with Guillain-Barré syndrome • paralysis of the lower body Kinnunen et al., 1998

  22. Discussion • Swine flu case as a decision analysis problem? • Exercise part 1: plan a DA study • Swine flu case as a risk management problem? • Exercise part 2: analyze RM in the case and propose and discuss alternative approach(es) • Is this feasible? Comprehensible?

  23. Swine flu – narcolepsy assessment: role of participation? • How could other people than experts have been participated in the narcolepsy assessment? • How should other people participate? • What additional value would this bring in?

  24. The five dimensions of openness: • Scope of participation, referring to who are allowed to participate in the process. • Access to information, referring to what information regarding the issue at hand is made available to participants. • Timing of openness, referring to when participants are invited or allowed to participate. • Scope of contribution, referring to which aspects of the issue at hand participants are invited or allowed to contribute to. • Impact of contribution, referring to what extent are participant contributions allowed to have influence on the outcomes, i.e. how much weight is given to participant contributions.

  25. Different aspects on the media content • What is discussed? Contents, discourses, meanings. • Who talks? Whose point of view is presented? How are issues framed? Interaction settings? • How do people talk? Argumentation, rhetoric methods, use of language, prejudices... • E.g. How is swine flu or authority, citizen or expert knowledge constructed? What meanings are communicated? In what ways?

  26. Important aspects in narcolepsy news (rough order of occurrence) • Emphasis on threat and fear • Taking over the problem • Reporting about the spread of swine flu • Preparedness and prevention • Survival and protection • Emphasising familiarity and safety • Impacts of swine flu • Criticising authorities • Advice about what should (have been) done • Emphasising the responsibility of authorities

  27. Development of narcolepsy assessment • Spring 2010 Neurologists surprised about # of new narcolepsy cases. • June 2010 Neurologists contact THL about their findings. • 18.8.2010 The MPA (Sweden) investigates reports of narcolepsy in patients vaccinated with Pandemrix MPA [1] • 18.8.2010 Expert: Unlikely that H1N1 vaccine and narcolepsy have connection YLE [2] • 18.8.2010 THL will study the connection. Vaccine and narcolepsy experts will meet in the afternoon to design the study. YLE • 19.8.2010 The study has been started. It will last for months. THL [3] • 24.8.2010 THL recommends to stop Pandemrix vaccination. THL [4] • 27.8.2010 European Medicines Agency starts review of Pandemrix EMA [5] YLE [6] • 23.9.2010 EMA: Evidence insufficient to determine causal link. Pandemrix benefits larger than risks. EMA [7]

  28. Development of narcolepsy assessment (2/2) • 8.9.2010 Swedish study shows no connection between vaccination and narcolepsy MTV3 [8] • 17.11.2010 Ties Between Big Pharma and THL Draw Complaints YLE [9] • 30.1.2011 Swine flu faccination to children maybe a mistake YLE [10] • 31.1.2011 First assessment report published by THL [11] • 1.2.2011 THL: Pandemrix vaccine increased the risk of narcolepsy YLE [12] • 18.2.2011 EMA: Causal relationship not established EMA [13] • August 2011: Final assessment report will be published by THL

  29. The five dimensions of openness: • Scope of participation, referring to who are allowed to participate in the process. • Access to information, referring to what information regarding the issue at hand is made available to participants. • Timing of openness, referring to when participants are invited or allowed to participate. • Scope of contribution, referring to which aspects of the issue at hand participants are invited or allowed to contribute to. • Impact of contribution, referring to what extent are participant contributions allowed to have influence on the outcomes, i.e. how much weight is given to participant contributions.