DARM DA study exercise Group 1

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Background

The 2009 flu pandemic was an outbreak of a new strain of H1N1 influenza virus, usually referred to as "swine flu". First described in April 2009, the influenza A(H1N1)v virus was a new virus subtype of influenza affecting humans, which contains segments of genes from pig, bird and human influenza viruses in a combination that had never been observed before anywhere in the world. A(H1N1)v virus is the result of a combination of two swine influenza viruses that contained genes of avian and human origin (ECDPC 2011). Unlike most strains of influenza, H1N1 does not disproportionately infect adults older than 60 years; this was an unusual and characteristic feature of the H1N1 pandemic (Writing Committee of the WHO 2010).

The outbreak began in the state of Veracruz, Mexico, with evidence that there had been an ongoing epidemic for months before it was officially recognized as such (McNeil 2009). The Mexican government closed most of Mexico City's public and private facilities in an attempt to contain the spread of the virus; however, it continued to spread globally, and clinics in some areas were overwhelmed by infected people. In June, the World Health Organization (WHO) and US Centers for Disease Control (CDC) stopped counting cases and declared the outbreak a pandemic (WHO/Chan 2009).

The H1N1 flu virus is typically contracted by person to person transmission through respiratory droplets (CDCP 2009). Symptoms usually last 4–6 days (Bronze 2009). The pandemic began to taper off in November 2009 (McKay 2009), and by May 2010, the number of cases was in steep decline (WHO 2010). On 10 August 2010 the World Health Organization announced the end of the H1N1 pandemic (Helsingin Sanomat 2010). According to the WHO statistics from July 2010, the virus had killed more than 18,000 people since it appeared in April 2009 (redOrbit 2010), approximately 4% of the 250,000 to 500,000 annual influenza deaths (WHO 2009).

Now the H1N1 influenza virus has moved into the post-pandemic period. However, localized outbreaks of various magnitudes are likely to continue. Influenza outbreaks, including those primarily caused by the H1N1 virus, show an intensity similar to that seen during seasonal epidemics. Recently published studies indicate that 20–40% of populations in some areas have been infected by the H1N1 virus and thus have some level of protective immunity. Many countries report good vaccination coverage, especially in high-risk groups, and this coverage further increases community-wide immunity (WHO 2010b).

In Finland the first laboratory confirmed cases of influenza A(H1N1) was discovered on May 2009. At that time the spread of influenza A(H1N1) to Finland was expected as the virus has spread widely around the world (THL 2009a). The first death in Finland associated with the A(H1N1)v influenza virus was confirmed in on October 2009. As of 26 October 2009, there had been 522 confirmed cases of influenza A(H1N1)v in Finland. In the same time the epidemic had continued its spread throughout Europe (THL 2009b).

The Ministry of Social Affairs and Health (MSAH) and the National Institute for Health and Welfare (THL) both recommended the vaccine, especially to the priority groups (health care professionals, pregnant women and persons aged from 6 months to 64 years belonging to a risk group due to another illness), to prevent the spread and severe complications of the illness (THL 2009b). The MSAH asked the THL to give opinion about getting vaccines. As the THL saw it, getting vaccines were very reasoned in that situation. By procurement it was confirmed to have vaccines fast. Firm reservation was made at the end of April 2009 right after the news from new epidemic had come (THL 2010).

Vaccination of health care personnel against influenza A(H1N1)v was initiated around the country during autumn. The plan was to start vaccinating pregnant women after health care personnel. After this, local authorities began vaccinating risk groups, according to the stated schedule. The proposal for the order of vaccination in Finland was approved by the Government in September 2009. The order was determined on medical grounds. Finland was among the first countries in Europe to receive the vaccine (THL 2009b).

The influenza vaccine being used in Finland was approved by the European Medicines Agency (EMEA), and it was also recommended by the World Health Organisation. The vaccine contained an adjuvant, a substance that enhances the immune response so less extract of the virus is needed in each dose. This immune response-enhancing substance had been thoroughly reviewed and tested even before it was considered for use in vaccines. The pandemic influenza vaccine had not been used in practice, but previous vaccines had provided data and knowledge on the behaviour of parts of it and other closely related vaccines. THL announced that the vaccine might cause side effects similar to seasonal flu vaccines, like a sore arm from the shot, headache, muscles aches, joint pains and mild fever. The vaccine effectiveness was expected to be good, about 90 percent (THL 2009b).

Since August 2010, following widespread use of vaccines against influenza (H1N1) 2009, cases of narcolepsy, especially in children and adolescents, have been reported from at least 12 countries. Narcolepsy is a rare sleep disorder that causes a person to fall asleep suddenly and unexpectedly. The rates reported from Sweden, Finland and Iceland have been notably higher than those from other countries (WHO 2011) .In Finland during 2009–2010, 60 children and adolescents aged 4–19 years were diagnosed with narcolepsy. This number is based on patient data collected from hospitals discharge registers and primary health care on all identified narcolepsy cases and an independent assessment of the patient records by an expert panel of neurologists and sleep researchers. When combining this information to pandemic vaccination data obtained from primary health care, it was noted that 52 persons, i.e. nearly 90 % of the cases, had received Pandemrix vaccine, when the vaccination coverage of that particular age group was 70 %. According to these preliminary results, which still need to be confirmed, the risk of narcolepsy in the age group of 4–19 years was 9-fold among those Pandemrix-vaccinated in comparison with those unvaccinated in the same age group, corresponding to a risk of about 1 case of narcolepsy per 12,000 vaccinated in this age group. The increase was most marked among those 5–15-years of age. No cases were observed in children less than 4 years of age. Among persons over 19 years of age the incidence of narcolepsy has not increased and there is no sign that the vaccine had had an effect on the risk for falling ill with narcolepsy. Overall, the observed association between the vaccine and narcolepsy in the age group of 4–19 years is so evident that it is unlikely that some underlying or so-called confounding factor could alone completely explain it (THL 2011).

Narcolepsy is a condition that has a strong genetic linkage. Of the cases of narcolepsy tested so far in Finland (n=22), diagnosed during 2009-2010, all have the same genotype. It is considered most likely that the Pandemrix vaccine increased the risk of narcolepsy in a joint effect in those genetically disposed with some other, still unknown, genetic and/or environmental factor (WHO 2011).

In those countries which used similar pandemic vaccines in 2009-2010, an increased incidence of narcolepsy in children and adolescents has been observed only in Finland, Sweden and Iceland. In contrast to Finland, increased numbers of narcolepsy have been observed also among unvaccinated children and adolescents in Iceland. In Norway, United Kingdom, Germany and Canada, an estimated total of 3,5 million 4–19 year old children and adolescents have been vaccinated with the same vaccine as in Finland with no sign of an increase in narcolepsy (THL 2011).

The association between narcolepsy and Pandemrix vaccine requires much further investigation (THL 2011).

Assessment of the World Health Organization actions relating to 2009 flu pandemic

The WHO's actions during 2009 H1N1 pandemic

H1N1 virus strain which eventually caused the 2009 flu pandemic was first reported in two U.S children in March 2009, although health officials have reported that it apparently infected people as early as January 2009 in Mexico. (Fox, Maggie, 2009) The actual outbreak was first detected in Mexico City on 18 March 2009 and immediately after that Mexico notified World Health Organization. On 7 May 2009 the WHO stated that containment was not feasible and that countries should focus on mitigating the effect of the virus. WHO did not recommend closing borders or restricting travel. In June 2009 the WHO and US Centers for Disease Control (CDC) stopped counting cases and declared the outbreak a pandemic. Director-General of the WHO, Margaret Chan, announced the end of pandemic on 10 August 2010.

Vaccine production dilemma

On May 14, 2009, the WHO officials had a meeting with representatives of pharmaceutical companies and the companies said they were ready to begin making swine flu vaccine. The WHO's experts were reported to present recommendations to WHO Director-General Margaret Chan who was expected to issue advice to vaccine manufacturers whether they should concentrate on making swine flu vaccine or seasonal flu vaccine since there was not enough production capacity to make both. WHO's Keiji Fukuda commented the issue saying "These are enormously complicated questions, and they are not something that anyone can make in a single meeting". Wrong decision about vaccine production could lead to severe consequences since the production cannot be switched halfway through if the decision turns out to be a mistake. Mass production of pandemic vaccine was in any case a gamble, as it took away manufacturing capacity for the vaccine for the seasonal flu which kills up to 500,000 people each year. Some experts have wondered if the world really needs a vaccine for an illness which so far appears mild. As of 19 November 2009, the WHO said that 65 million doses of vaccine had been administered and that it had a similar safety profile to the seasonal flu vaccine. Reported rate of "serious events" was one in 200,000 doses. GlaxoSmithKline recalled one batch of vaccine in Canada after it appeared to cause higher rates of adverse events than other batches. (Smith, Joanna, Toronto Star, Nov 20 2009)

Pandemic and the media

Critics have claimed the WHO had exaggerated the danger, spreading "fear and confusion" rather than immediate information. The WHO has began an investigation to determine whether it has "frightened the people unnecessarily". On April 12, 2010, Keiji Fukuda, the WHO's top influenza expert, stated that the system leading to pandemic alert led to confusion about H1N1 circulating around the world, and he expressed concern that there was a failure to communicate in regard to uncertainties about the new virus, which turned out to be not as deadly as had been feared. WHO Director-General Margaret Chan has appointed a group of experts from outside the organization to conduct a "frank, critical, transparent, credible and independent" review of WHO's performance of handling the H1N1 flu pandemic. (Chan 8 June 2010) The pandemic turned out to be much less severe than was expected at the time of initial pandemic alert. The initial outbreak received weeks of near-constant media attention. Epidemiologist have cautioned that the number of cases reported in the early days of an outbreak can be very inaccurate and deceptive due to several causes, like for example selection bias, media bias and incorrect reporting by the governments. Also the number of cases is actually meaningless to track since so many people contract the mild form of H1N1 as was pointed out by Dr. Michael T. Osterholm (director of the Center for Infectious Disease Research). It is the writers opinion that the 2009 swine flu case serves as a perfect example of the modern online media's power to choose which matter is important and which is not. It seems likely that there would not have been a global pandemic alert had the media not taken so disproportionate interest on the 2009 swine flu case. It is probably very difficult to make rational decisions when screaming headlines are reporting every new case of swine flu all over the world. Thus it is possible that the pressure from constant media attention pushed the WHO leaders to "play it safe" and issue global pandemic alert, despite the fact that scientific evidence about swine flu 2009 strain hazards was not yet available. To put the 2009 swine flu pandemic in proportion with its over 18,000 deaths according to the WHO, there are around 781,000 deaths caused by malaria each year. (World malaria report 2010, WHO)

⇤--#: . Rather than making lengthy literature reviews, focus on defining the purpose of your study. Then, you can limit the review on the issues relevant for the purpose. --Jouni 19:21, 15 March 2011 (EET) (type: truth; paradigms: science: attack)

Scope

Purpose

• purpose of the DA study: Purpose of this DA study is to evaluate the impact of vaccination in Finland.
• question(s) addressed in the study: Can it be considered that the right decisions were made? Which decisions should have been made?
• the relation of the study to the overall swine flu case
• roles of different actors related to the study
• expected and possible impacts of the study
• intended (even if imaginary) use of the study: Developing new approaches for MSHA etc...

Boundaries

• spatial and temporal boundaries the study: assessment from Finland, from June 2009 to March 2011

Scenarios

   * Scenarios define particular conditions that are of interest irrespective whether they describe 
     reality or not (e.g. what-if scenarios).

Intended users

• Ministry of Social and Health Affairs of Finland

Participants

Anna Kokkonen, Jukka-Pekka Männikkö, Oluyemi Toyinbo (Group 1)

Definition

• decisions and decision options considered in the study: Vaccination of risk groups or no vaccination at all
• outcomes of interest that the decisions (are considered to) have influence on: prevent or at least limit the spread to Finland, vaccination coverage (vaccineted/non vaccinated, side effects) prevent panic
• the relationships between the decisions and outcomes of interest (e.g. as a network of variables)
• different sources of information needed/used in the study: WHO, THL etc...
• means, methods, and tools (e.f. software) needed for the study
• description of a (executable) calculative DA model
• description of the execution of the model
• analyses on the model, its parts, and its results (e.g. uncertainty, sensitivity, VOI, applicability, ...)

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Decision variables

   * Decision variables: decisions that are considered.

Indicators

   * Indicators: outcome variables of interest.

Value variables

   * Value variables: value judgements (usually about indicators).

Other variables

   * Other variables: any variables that link to the causal network and are within the boundaries of the assessment.

Analyses

   * Analyses: statistical and other analyses that contain two or more variables, e.g. optimizing.

Indices

   * Indices: lists of particular locations along spatial, temporal, or other dimensions.

Result

   * Results of indicators and assessment-specific analyses. 

Conclusions

   * Conclusions are based on the results, given the scope. 

References

Chan M. 2009. World now at the start of 2009 influenza pandemic. World Health Organization.http://www.who.int/mediacentre/news/statements/2009/h1n1_pandemic_phase6_20090611/en/index.html. Published 11.6.2009

Centers for Disease Control and Prevention (CDCP). 2009. Updated Interim Recommendations for the Use of Antiviral Medications in the Treatment and Prevention of Influenza for the 2009–2010 Season. H1N1 Flu. http://www.cdc.gov/h1n1flu/recommendations.htm. Published 7.12.2009

Bronze, MS. H1N1 Influenza (Swine Flu). eMedicine. Medscape. http://emedicine.medscape.com/article/1673658-overview. Published 13.11.2009

Helsingin Sanomat. 2010. WHO julisti: Sikainfluenssa on ohi. Published 10.8.2010 http://www.hs.fi/kotimaa/artikkeli/WHO+julisti+Sikainfluenssa+on+ohi/1135259234155

McKay B. (2010-03-02). The Flu Season That Fizzled. The Wall Street Journal. http://online.wsj.com/article/SB10001424052748703429304575095743102260012.html. Published 2.3.2010

McNeil DG. 2009. In New Theory, Swine Flu Started in Asia, Not Mexico". The New York Times. http://www.nytimes.com/2009/06/24/health/24flu.html. Published 23.6.2009

National Institute for Health and Welfare (THL). 2009a. Ministry of Social Affairs and Health: Two cases of influenza A(H1N1) confirmed in Finland. Published 12.5.2009 http://www.thl.fi/en_US/web/en/pressrelease?id=13307

National Institute for Health and Welfare (THL). 2009b. THL and MSAH: Influenza A(H1N1)v epidemic about to start, first death in Finland confirmed. Published 27.10.2009 http://www.thl.fi/en_US/web/en/pressrelease?id=21364

National Institute for Health and Welfare (THL). 2010. Pandemiarokotehankinnasta piti päättää nopeasti. Published 19.11.2010 http://www.thl.fi/fi_FI/web/fi/uutinen?id=23508

National Institute of Health and Welfare (THL). 2011. Interim Report of the National Narcolepsy Task Force, 31 January 2011. Published 31.3.2011.

RedOrbit. 2010. H1N1 Still A Pandemic, Says WHO. 2010. http://www.redorbit.com/news/health/1893907/h1n1_still_a_pandemic_says_who/. Published 20.7.2010

WHO. 2009. Influenza (Seasonal). April 2009. http://www.who.int/mediacentre/factsheets/fs211/en/. Retrieved 2010-02-13.

WHO. 2010a. Global Update on 2009 H1N1. Global Intensity Map, Week 17 (April 26, 2010-May 2, 2010). http://gamapserver.who.int/h1n1/qualitative_indicators/atlas.html?indicator=i2&date=Week%2017%20(26-Apr-2010%20:%2002-May-2010)

WHO 2010b. H1N1 in post-pandemic period. Director-General's opening statement at virtual press conference. Published 10.8.2010 http://www.who.int/mediacentre/news/statements/2010/h1n1_vpc_20100810/en/index.html

WHO. 2011. Statement on narcolepsy and vaccination. Published 8.2.2011. http://www.who.int/vaccine_safety/topics/influenza/pandemic/h1n1_safety_assessing/narcolepsy_february2011/en/index.html

Writing Committee of the WHO Consultation on Clinical Aspects of Pandemic (H1N1) 2009 Influenza. 2010. Clinical Aspects of Pandemic 2009 Influenza A (H1N1) Virus Infection. The New England Journal of Medicine 362: 1708–19 http://www.nejm.org/doi/full/10.1056/NEJMra1000449