swine flu story mikko pohjola, thl. contents introductory overview step by step walk-through of the...
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Swine flu storyMikko Pohjola, THL
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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 – Participation and openness in the swine flu – narcolepsy assessment
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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
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The threat in summer 2009
• mortality 0,6% of those infected
• Infects 5-15% of poulationhttp://fi.wikipedia.org/wiki/Vuoden_2009_sikainfluenssapandemia
• I.e. ca. 500.000 with swine flu (according to10%) and 3.000 deaths
ca. 100 nm
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Global situation 2009
WHO pandemic-alert:
4 - 27.4.2009
5 - 29.5.2009
6 - 11.6.2009
(6 is the highest alert level)
4 5 6
2009
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Narcolepsy incidence in Finland
0
20
40
60
80
100
120
2006 2007 2008 2009 2010
Vuosi
Nar
kole
psi
atap
auks
ia S
uo
mes
sa
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Age-stratified narcolepsy incidence in Finland
0
5
10
15
20
25
30
35
0-4 5-9 10-14
15-19
20-24
25-29
30-34
35-39
40-44
45-49
50-54
55-59
60-64
65-69
70-74
75-79
80-
2006
2007
2008
2009
2010
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Narcolepsy (ICD-10 G47.4)
• Wikipedia:– a chronic sleep 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”
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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
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www.thl.fi > sikainfluenssahttp://www.thl.fi/thl-client/pdfs/f890b9f3-9922-4efe-889b-157fe2e03aa4
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.
THLdosentti Terhi Kilven THL:n Rokotusten ja immuunisuojan
osastolta, lääketieteen tohtori Hanna Nohynekin THL:n
Rokotusohjelmayksiköstäfilosofian tohtori Jukka Jokisen THL:n Rokotetutkimusyksiköstä, tutkimusprofessori Ilkka Julkusen THL:n Virusinfektioyksiköstä tutkimusprofessori Outi Vaaralan THL:n Immuunivasteyksiköstä.
A committee was set on 13.10.2010to study the possible connection betweenPandemrix vaccine and narcolepsy
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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
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Narcolepsy in other countries
Iceland: icreased narcolepsy incidence also among non-vaccinated
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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)
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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
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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
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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
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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 women3. 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 months5. Healthy children and young people of age 3-24 years, and those
currently in military service6. Risk groups of age 65 years and older7. Others
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Vaccinations
0
50 000
100 000
150 000
200 000
250 000
300 000
350 000
400 000
450 000
0-4 5-9 10-14
15-19
20-24
25-29
30-34
35-39
40-44
45-49
50-54
55-59
60-64
65-69
70-74
75-79
80-
Ikäryhmä
Väe
stö
mää
rä i
käry
hm
ittä
in
Rokottamatta
Rokotetut
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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)
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Vaccine efficacy?
• Did the vaccination campaign subdue the epidemic or was it already subsiding by itself?
• Herd immunity?
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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
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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?
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Swine flu and narcolepsy – assessment: openness and participation
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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?
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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
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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?
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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.
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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]
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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
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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.