Difference between revisions of "Talk:Assessment of the health impacts of H1N1 vaccination"

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[[Category:Decision analysis and risk management]]
 
[[Category:DARM exercise]]
 
[[Category:DARM exercise]]
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==[[Darm]] exercise 4==
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== Evaluation of the H1N1 assessment ==
  
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'''Tasks:
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The evaluation was originally made for the purpose of demonstrating the application of the properties of good assessment framework in an article considering evaluation of model and assessment effectiveness, but in the end was omitted from the manuscript. Here the assessment of the health impacts of H1N1 vaccination is evaluated according to the application of the Properties of Good Assessment framework, originally published by Tuomisto and Pohjola (2007). For the purpose of this evaluation, the framework has been slightly updated as is described in [[Properties of good assessment]].
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* Make pairs and select one group A-E (D and E have Finnish material).
 
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* Look at page [[Discussion]] for theoretical and practical advice. Also page [[:op_fi:Keskustelun jälkijäsentäminen]] may be useful.
 
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* Look at the two or three links on your group's page.
 
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* Read the texts and try to identify arguments about the use of Pandemrix. Note that arguments can be (and most are) indirect arguments.
 
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* Rewrite the arguments in such a way that they can be understood outside the original context.
 
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* Place the arguments into a hierarchical tree of attacking and defending arguments pointing toward the main statement about Pandemrix use.
 
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* You can also make up your own arguments, or if you have extra time, read additional material (see end of the page).
 
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* When each group has done their own part, there will be a general discussion about all argumentations by the groups. All argumentations will be merged onto this page based on the discussion.
 
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* Think: How many readers do you need to make this extra effort of collecting, organising and synthesising information and opinions a worthwhile activity of social learning?
 
  
 +
On the course the assessment primarily served the purposes of illustrating essential aspects of decision analysis and risk management, as well as an explicating the swine flu (AH1N1 influenza) pandemic and related vaccination campaign in Finland 2009 - 2010 as examples of practical contexts for decision analysis and risk management. Here we focus on its secondary purpose: to evaluate the decision to launch a nationwide vaccination campaign to alleviate the pandemic in Finland. The discourse erupted during autumn 2010 when suspicions regarding a relationship between the AH1N1 vaccine and the sudden increase in prevalence of narcolepsy in Finland were publicized in the media. Soon after that the National Institute for Health and Welfare (THL) in Finland set up a task force to determine whether such a causal relationship exists (THL, 2011a,b).
  
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The group specific pages can be improved until Monday (4.4.) evening.
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The setting for evaluating the assessment:
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Evaluation of the exercise will be based on the contents of the group pages as of Monday evening.
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* Time of assessment: spring 2011.
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The argumentation by different groups will be compiled on this page and discussed more on the lecture on Thursday 7.4.
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* Assessors: organizers of the DARM course, participants of the course.
 +
* Intended primary user: Ministry of Social Affairs and Health in Finland.
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* Intended use: basis for communication about public concerns regarding swine flu vaccines and narcolepsy.
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* Evaluation method: qualitative expressions on a 5-point scale from very low to very high.
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* Evaluation focus: whole assessment (main message, supported by all other information).
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* Basis for evaluation: information provided on the assessment page in Opasnet, complemented with additional information obtained from assessment participants where necessary.
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 +
 
 +
{|{{prettytable}}
 +
|+ '''Table 2. Evaluation of the assessment of the health impacts of H1N1 vaccination
 +
|-----
 +
! Category
 +
! Property
 +
! Characterization
 +
! Explanation
 +
|-----
 +
| rowspan="3"| Quality of content
 +
| Informativeness
 +
| Medium
 +
| The conclusion that vaccinating whole population was a better alternative than no vaccination is well supported by the model results. The conclusion that vaccinating whole population was a better alternative than vaccinating all except 5-19 old is more vaguely supported. The uncertainty of some variables in the model is high.
 +
|-----
 +
| Calibration
 +
| Medium
 +
| Model results and assessment conclusions are in line with the analyses by the European Medical Agency (EMA, 2011) and the National narcolepsy task force in Finland (THL, 2011b). The calibration of some variables in the model, e.g. DALY weight for narcolepsy, may well be questioned as they are based on assumptions rather than data.
 +
|-----
 +
| Coherence
 +
| High
 +
| The question is well addressed and the answer is reasoned with a model that takes account of the most important factors known to have effect on the outcome. Limitations in the comprehensiveness of the model and its parts exist, e.g. in terms of assumptions, but many of them identified and explicated. Value of information analysis indicates high coherence within the assessment.
 +
|-----
 +
| rowspan="4"| Applicability
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| Relevance
 +
| Very low (potentially high)
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| The assessment addresses an issue that can be considered as underlying much of the discussion regarding the swine flu pandemic and the vaccination campaign. The assessment could thus be claimed to serve a real, existing need and the potential relevance could be considered high. However, in reality there was practically no interaction between the assessors and intended users and there was no demand from the users for the assessors to address the question. Consequently, the actual relevance is very low.
 +
|-----
 +
| Availability
 +
| Low (potentially very high)
 +
| The model was developed and presented on a freely accessible assessment page in Opasnet at a time when many of the issues related to the case were still unresolved and under active public discussion. Practically no technical limits to availability exist. However, awareness about the assessment among intended users remained low despite (or due to only) the minor efforts of informing them by e-mail. Consequently, the relevance is actually low, although potentially very high.
 +
|-----
 +
| Usability
 +
| Medium
 +
| The main message and its basis is presented in a structured way and is relatively easily perceivable even for non-experts. Assumptions and limitations are described and access to the data and calculations is provided and easy. However, obtaining a deeper and detailed understanding of the model requires specific knowledge, detailed scrutiny, and possibly also assistance from the developers. Explication of the intended use and guidance of use are omitted from the assessment (cf. use plans in Vermaas and Houkes, 2006). Due to lack of interaction with users the actual usability in intended use is unknown.
 +
|-----
 +
| Acceptability
 +
| Medium
 +
| The open approach can be considered to have increased acceptability in a situation where authorities were accused for non-warranted withholding of important information. On the other hand the model was developed by non-experts regarding infectious diseases and vaccines. Also the credibility of the organization, THL, that the main developers represented was strongly questioned in public at the time of developing and delivering the model. Due to lack of interaction with users the actual acceptability in intended use is unknown.
 +
|-----
 +
| rowspan="2"| Efficiency
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| Intra-assessment efficiency
 +
| High
 +
| The assessment was developed as a side product of the DARM course. The development of the model consumed about 2 person months work, consisting mostly of the efforts of the course assistant, a high school graduate with good mathematical and computer skills, but no prior specific expertise on vaccines or infectious diseases.
 +
|-----
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| Inter-assessment efficiency
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| High
 +
| The assessment is mostly structured as independent variables that are applicable in other assessments. The assessment also applies some variables that were developed in previous assessments. However, the calculation in the model for the most part was not coded as independently applicable modules.
 +
|-----
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| Overall evaluation
 +
| Effectiveness
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| Low
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| Despite mostly relatively good scores with regard to many properties, the overall effectiveness remains low because the intended use did not take place in reality. The potential for outcome effectiveness can be seen, but the failure of the delivery, i.e. lack of interaction between the assessment and its use, prevents it from becoming realized. The realized impacts are mostly process effects, increasing the knowledge among the participants of the assessment. As many of the participants work in roles that are relevant to the interests of the intended user, the Ministry of Social Affairs and Health, it can be assumed that some of that knowledge will eventually trickle to its intended use, but indirectly and with delay.
 +
|}
 +
 
 +
The example assessment can be considered as somewhat typical in the sense that it fails to convey its as such good results into practice. Although the evaluation example above can be considered somewhat superficial, and is made only qualitatively, it highlights some important aspects of assessment and model performance:
 +
# In terms of outcome effectiveness, there is a major difference between the potential of an assessment or model to deliver its intended outcomes and the actual delivery thereof.
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# The properties that have been least addressed within the common contemporary approaches to performance, namely relevance and availability, are critical for transforming the potential of an assessment or model to effectiveness.
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# The delivery of the assessment or model outputs to their intended use is necessary to take account of in considering assessment and model performance.
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# Improving effectiveness of assessments and models is not an issue to be addressed within the communities of assessment and modelling, but requires simultaneous development of the use processes and the capacity of policy making to make use of what assessments and models can deliver.
 +
 
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The major limitations of the assessment indicated by the evaluation according to the properties of good assessment may seem apparent, but they would probably not show up in evaluations applying more conventional approaches. Altogether, the example shows that, despite still lacking explicit methods for its application, the Properties of Good Assessment framework can already be a useful and powerful means for evaluating and managing assessment and model performance.
 +
 
 +
=== References ===
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 +
EMA, 2011. Press release 27 July 2011: European Medicines Agency recommends restricting use of Pandemrix. European Medicines Agency. Available: http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2011/07/WC500109182.pdf
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 +
THL, 2011a. National narcolepsy task force interim report 31 January 2011. National Institute for Health and Welfare (THL), Helsinki. Available: http://www.thl.fi/thl-client/pdfs/dce182fb-651e-48a1-b018-3f774d6d1875
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 +
THL, 2011b. National narcolepsy task force final report 31 August 2011 (in Finnish). National Institute for Health and Welfare (THL), Helsinki. Available: http://www.thl.fi/thl-client/pdfs/c02a3788-a691-47a4-bca8-5161b6cff077 
 +
 
 +
Vermaas, P.E., Houkes, W., 2006. Technical functions: a drawbridge between the intentional and structural natures of technical artefacts. Studies in History and Philosophy of Science 37, 5-18.
  
 
== Pandemrix should not be used because of narcolepsy risk ==
 
== Pandemrix should not be used because of narcolepsy risk ==
 +
 +
Instructions for the exercise 4 of [[Darm]] course 2011 can be found [http://en.opasnet.org/en-opwiki/index.php?title=Talk:Assessment_of_the_health_impacts_of_H1N1_vaccination&oldid=24741 here]
  
 
{{discussion
 
{{discussion
 
|Statements= Pandemrix should not be used any more anywhere because its narcolepsy risk is too high.
 
|Statements= Pandemrix should not be used any more anywhere because its narcolepsy risk is too high.
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|Resolution=  
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|Resolution= Not accepted. Pandemrix is still an effective and safe vaccine. However, due to precautionary reasons, other alternatives should be used when available, because the occurrence of narcolepsy is not understood.
 +
|Resolved = Yes
 
|Argumentation =
 
|Argumentation =
−
{{attack|B10 |All data compiled to date indicate that pandemic vaccines including Pandemrix match the excellent safety profile of seasonal influenza vaccines, which have been used for more than 60 years.|--[[User:Oluyemitoyinbo|Oluyemitoyinbo]] 11:12, 1 April 2011 (EEST)}}
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{{attack|J5 |Pandemrix is a safe vaccine and narcolepsy risk is low. |--[[User:Jouni|Jouni]] 18:17, 6 April 2011 (EEST)}}
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 +
{{Hidden |
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:{{defend|D5 |Compared to other vaccines, Pandemrix has a lower Hg content (2.5 vs 25 µg), which could cause neurological problems in children|--[[User:Carmen Gil|Carmen Gil]] 11:25, 1 April 2011 (EEST)}} <ref name="rokotusinfoswineflu">[http://www.rokotusinfo.fi/rokotteet/sikainfluenssa_html Rokotusinfo: Swine flu]</ref>
 +
 
 +
:{{defend|J4 | Pandemrix probably does not cause narcolepsy except in Finland and Sweden, where there may be genetic or other factors triggering the risk. Therefore, global conclusions cannot be made. |--[[User:Jouni|Jouni]] 18:17, 6 April 2011 (EEST)}}
 +
 
 +
::{{defend|A1 |According to EMA, data received so far is still insufficient to establish a causal relationship between Pandemrix and narcolepsy. One possible explanation for the results is that Pandemrix could interact with unknown local environmental and/or genetic factor in contributing to the increased risk of narcolepsy among the vaccinated population aged 4 to 19 years in Finland|--[[User:Jacob Attipoe|Jacob Attipoe]] 11:18, 1 April 2011 (EEST)}}
 +
 
 +
::{{defend|B2 |The European Medicines Agency says that no link between the Pandemrix swine flu vaccine and narcolepsy has been established|--[[User:Oluyemitoyinbo|Oluyemitoyinbo]] 12:17, 4 April 2011 (EEST)}} <ref>[http://yle.fi/uutiset/news/2010/09/eu_agency_no_link_between_pandemrix_and_narcolepsy_2006172.html YLE: EU agency does not find link between Pandemrix and narcolepsy]</ref>
 +
 
 +
::{{defend|A2 |The overall annual incidence of narcolepsy remained consistent with prevaccination scenarios.|--[[User:Jacob Attipoe|Jacob Attipoe]] 11:22, 1 April 2011 (EEST)}}
  
−
{{attack|B11 |Adjuvanted vaccines commonly provide a stronger immune response than unadjuvanted vaccines and also provide a broader immune response allowing for some potential drift of the influenza virus (Pandemrix is an adjuvanted vaccine).|--[[User:Oluyemitoyinbo|Oluyemitoyinbo]] 11:12, 1 April 2011 (EEST)}}
+
::{{defend|A4 |No similar increase in incidence of narcolepsy is reported in other Nordic countries. Canada has extensively used this type of vaccine with no evidence of increased risk for narcolepsy|--[[User:Jacob Attipoe|Jacob Attipoe]] 11:18, 1 April 2011 (EEST)}}
  
−
{{attack|B12 |The number of cases of side effects of H1N1 vaccines (including Pandemrix) is in line with normal background rates on a population basis, as reported in a recent study European Medicines Agency |--[[User:Oluyemitoyinbo|Oluyemitoyinbo]] 11:12, 1 April 2011 (EEST)}}
+
::{{comment|# |Is this a defence of argument A3b rather an attack?|--[[User:Jouni|Jouni]] 07:05, 2 April 2011 (EEST)}}
  
−
{{attack|A1 |According to EMA, data received so far is still insufficient to establish a causal relationship between Pandemrix and narcolepsy. One possible explanation for the results is that Pandemrix could interact with unknown local environmental and/or genetic factor in contributing to the increased risk of narcolepsy among the vaccinated population aged 4 to 19 years in Finland|--[[User:Jacob Attipoe|Jacob Attipoe]] 11:18, 1 April 2011 (EEST)}}  
+
::{{defend|B3 |According to THL's (Finnish National Institute for Health and Welfare) Vaccine Department's head, Dr. Terhi Kilpi,`the Pandemrix vaccine alone did not cause narcolepsy in Finnish children`.|--[[User:Oluyemitoyinbo|Oluyemitoyinbo]] 09:51, 4 April 2011 (EEST)}} <ref name="rokotusinfo"/>
  
−
{{attack|A2 |The overall annual incidence of narcolepsy remained consistent with prevaccination scenarios|--[[User:Jacob Attipoe|Jacob Attipoe]] 11:22, 1 April 2011 (EEST)}}
+
:{{defend|A3a |Even though a nine fold increase in narcolepsy was found in vaccinated population, the occurrence of narcolepsy was still very rare with this apparent increase.|--[[User:Jacob Attipoe|Jacob Attipoe]] 11:18, 1 April 2011 (EEST)}}
 +
 
 +
::{{comment|# |This sounds like an attack, not defence, of the main statement. The same applies to A3b.|--[[User:Jouni|Jouni]] 07:05, 2 April 2011 (EEST)}}
 +
 
 +
:{{defend|A3b | A number of different reasons may account for the observed rise in the incidence of narcolepsy namely: (H1N1) infection, vaccination, combined effect of infection and vaccination, or some other factor entirely. Infections have been documented as causing narcolepsy.|--[[User:Jacob Attipoe|Jacob Attipoe]] 11:18, 1 April 2011 (EEST)}}
 +
 
 +
::{{comment|# |I divided your argument into two because the parts seem to be separate things.|--[[User:Jouni|Jouni]] 07:05, 2 April 2011 (EEST)}}
 +
 
 +
:{{defend|B1 |All data compiled to date indicate that pandemic vaccines including Pandemrix match the excellent safety profile of seasonal influenza vaccines, which have been used for more than 60 years.The number of cases of side effects of H1N1 vaccines (including Pandemrix) is in line with normal background rates on a population basis.(European Medicines Agency.) |--[[User:Oluyemitoyinbo|Oluyemitoyinbo]] 11:12, 1 April 2011 (EEST)}} <ref name="ecdc_qa">[http://ecdc.europa.eu/en/healthtopics/H1N1/vaccines/Pages/QA_health_professionals_vaccines.aspx European Centre for Disease Prevention and Control (ECDC): Questions and answers]</ref>
 +
 
 +
}}
 +
 
 +
{{attack|J5 |Pandemrix is an effective vaccine with strong benefits.|--[[User:Jouni|Jouni]] 18:17, 6 April 2011 (EEST)}}
 +
 
 +
:{{defend|B4 |Adjuvanted vaccines commonly provide a stronger immune response than unadjuvanted vaccines and also provide a broader immune response allowing for some potential drift of the influenza virus (Pandemrix is an adjuvanted vaccine).|--[[User:Oluyemitoyinbo|Oluyemitoyinbo]] 11:12, 1 April 2011 (EEST)}} <ref name="ecdc_qa"/>
 +
 
 +
:{{defend|B5 |A positive effect of the vaccine can be felt from pregnant women, it gives immunization to the mother-to-be and the new born that is not eligible for vaccination until the age of six months. The adverse events reported so far have mainly been symptoms such as fever, nausea, headache, allergic reactions and injection site reactions, confirming the safety profile of the vaccine. The vaccine can even be given to breastfeeding mothers and this will reduce the chance that the infant will get influenza.|--[[User:Oluyemitoyinbo|Oluyemitoyinbo]] 11:20, 1 April 2011 (EEST)}} <ref name="ecdc_qa"/>
 +
 
 +
:{{defend|E7 |Vaccination is a very good method of preventing swine flu infections.|--[[User:Sallamari Tynkkynen|Sallamari Tynkkynen]] 10:59, 1 April 2011 (EEST)}} <ref name="thl20101209"/>
 +
 
 +
{{attack|D3b |The vaccine may still have been used where no other option was available and upon consideration in individual cases, for instance for people travelling to areas where an epidemic was in progress.|--[[User:Carmen Gil|Carmen Gil]] 11:25, 1 April 2011 (EEST)}} <ref name="thl20100825">[http://www.thl.fi/en_US/web/en/pressrelease?id=22930 THL press release 25 Aug 2010]</ref>
 +
 
 +
{{attack invalid|J1 |Despite risks, Pandemrix is an effective vaccine and has clearly net positive effects in countries where emergency treatment is poorly available for severe swine flu cases.|--[[User:Jouni|Jouni]] 23:05, 31 March 2011 (EEST)}}
 +
 
 +
{{hidden|
 +
 
 +
:{{attack|D2 |By September 2010 there was no conclusive prelimininary impact of the vaccine in other countries and research was ongoing in several countries to monitor the effect of the vaccine in preventing illness and death. Side effects are still there and will be treated poorly in these countries.|--[[User:Carmen Gil|Carmen Gil]] 11:25, 1 April 2011 (EEST)}} <ref name="thl20100825"/>
 +
 
 +
:{{defend|E4 |The side effects of Pandemrix have been accentuated, although the benefits are much more significant.|--[[User:Sallamari Tynkkynen|Sallamari Tynkkynen]] 10:50, 1 April 2011 (EEST)}} <ref name="hsarkkiatri">[http://www.hs.fi/kotimaa/artikkeli/MTV3+Arkkiatri+moittii+sikainfluenssarokotteen+vastustajia/1135250236010 Helsingin Sanomat]: Arkkiatri moittii sikainfluenssarokotteen vastustajia (in Finnish)</ref>
 +
 
 +
:{{defend|D1 |This statement is true in the case of Finland that preliminary analyses of the impact of the swine flu epidemic in Finland in 2009 indicated that there were far fewer severe cases of influenza among pregnant women, who were among the first to be given the vaccine, than in countries where the first wave of influenza occurred before vaccinations were started. Also,in Europe alone, Pandemrix had been given to at least 30 million people and by end of August 2010 Sweden and Finland reported  a total of 26 cases of narcolepsy. I dont think this risk is too high as the statement suggests|--[[User:June|June]] 00:56, 3 April 2011 (EEST)}} <ref name="thl20100825"/>
 +
 
 +
:{{defend|C2 |According to Gennady Onishchenko, Russian Federation's chief doctor, the mortality rate at June 2009 was 1,6% in Mexico and 0,1% in United States. This supports the view that vaccination would be more useful in countries where emergency treatment for severe flu is poorly available.|--[[User:Jpmannikko|Jpmannikko]] 19:28, 4 April 2011 (EEST)}}
 +
 
 +
:{{defend|C3 |In a review by the U.S. National Institutes of Health, the 2009 flu pandemic vaccines appear both effective and safe, having a similar safety profile to the normal seasonal influenza vaccine.|--[[User:Jpmannikko|Jpmannikko]] 17:00, 4 April 2011 (EEST)}}
 +
 
 +
::{{attack invalid|C4 |According to CDC Pandemrix is not licenced for use in the United States, which implies safety concerns.|--[[User:Jpmannikko|Jpmannikko]] 17:15, 4 April 2011 (EEST), --[[User:Jouni|Jouni]] 06:55, 6 April 2011 (EEST)}}
 +
 
 +
:::{{comment|# |I added some clarification, because the mere fact about the lisence status is irrelevant.|--[[User:Jouni|Jouni]] 06:55, 6 April 2011 (EEST)}}
 +
 
 +
:::{{attack|C5 |Arepanrix, a H1N1 influenza vaccine similar to Pandemrix and also made by GSK was used in Canada. There has been no increase in narcolepsy cases in Canada reported.|--[[User:Jpmannikko|Jpmannikko]] 17:15, 4 April 2011 (EEST)}}
 +
 
 +
}}
 +
 
 +
{{defend invalid|J2 |The reputation of Pandemrix is globally so poor that it is impossible to use it any more.|--[[User:Jouni|Jouni]] 23:05, 31 March 2011 (EEST)}}
 +
 
 +
{{hidden|
 +
 
 +
:{{attack|B7 |Pandemrix vaccine was used in 38 countries worldwide during the 2009/2010 season. Increased cases of narcolepsy have been observed only in Finland, Iceland and Sweden (W.H.O). This I think makes its global reputation intact.|--[[User:Oluyemitoyinbo|Oluyemitoyinbo]] 12:27, 4 April 2011 (EEST)}} <ref>[http://www.euro.who.int/en/what-we-do/health-topics/disease-prevention/vaccines-and-immunization/news/news/2011/02/pandemrix-vaccine-and-increased-risk-of-narcolepsy WHO Europe]: Pandemrix® vaccine and increased risk of narcolepsy</ref>
 +
 
 +
:{{attack|C7 |Pandemrix has been approved by the European Medicines Agency. Increased narcolepsy rates have only been reported in Finland and Sweden, and not for example in Great Britain, where Pandemrix formed the bulk of governments mass vaccination programme.|--[[User:Jpmannikko|Jpmannikko]] 17:25, 4 April 2011 (EEST)}}
 +
 
 +
:{{attack|D6 |The reputation may have been poor especially in Finland, Sweden and in informed people outside these two countries at the time Narcolepsy cases were reported to be associated with Pandemrix but at this stage, however according to WHO it does not appear that narcolepsy following vaccination against pandemic influenza is a general worldwide phenomenon as you have stated, therefore its not a global view and it may still be used where its reputation is good.|--[[User:June|June]] 02:45, 3 April 2011 (EEST)}} <ref>[http://www.who.int/vaccine_safety/topics/influenza/pandemic/h1n1_safety_assessing/narcolepsy_february2011/en/index.html WHO Global Advisory Committee on Vaccine Safety]: Statement on narcolepsy and vaccination</ref>
 +
 
 +
:{{attack|E9 |The information supplied on the safety and effectiveness of three of the pandemic-influenza vaccines was considered complete enough for the Agency's Committee for Medicinal Products for Human Use  to recommend their use outside a pandemic situation. |--[[User:Anna Kokkonen|Anna Kokkonen]] 11:10, 1 April 2011 (EEST)}} <ref name="emaswineflu">[http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000461.jsp&murl=menus/special_topics/special_topics.jsp&mid=WC0b01ac05801d7bfe&jsenabled=true European Medicines Agency (EMA)]: Information page on Swine flu</ref>
 +
 
 +
::{{comment|# |I am not sure if this is a convincing argument about reputation. However, you may want to create a new argument about the safety of Pandemrix, and then it would be defended by this argument.|--[[User:Jouni|Jouni]] 08:15, 2 April 2011 (EEST)}}
 +
 
 +
:{{attack|K3 |GSK believes that it is premature to make any conclusions about the possible link of Pandemrix and narcolepsy until the large and ongoing European Medicines Agency investigation about the issue has been concluded. |--[[User:Kati Iso-Markku|Kati Iso-Markku]] 21:50, 6 April 2011 (EEST)}}
 +
 
 +
:{{defend|K1 |Since the summer of 2010 there have been reports from Finnish and Swedish health care workers about narcolepsy being a possible adverse effect of the Pandemrix vaccination. Also the Swedish Medical Products agency is aware of individual case reports from France, Norway and Germany concerning the recently vaccinated children developing narcolepsy.|--[[User:Kati Iso-Markku|Kati Iso-Markku]] 21:35, 6 April 2011 (EEST)}}
 +
 
 +
:{{defend|K4 |WHO´s Global Advisory Committee on Vaccine Safety noted that narcolepsy due to vaccination against pandemic influenza does not appear to be a general worldwide phenomenon.|--[[User:Kati Iso-Markku|Kati Iso-Markku]] 22:04, 6 April 2011 (EEST)}}
 +
 
 +
:{{defend|K2 |THL stated in 2/2011 that there is a clear link between Pandemrix vaccination and narcolepsy. With the vaccination, the probability of narcolepsy was nine times higher than without it.|--[[User:Kati Iso-Markku|Kati Iso-Markku]] 21:40, 6 April 2011 (EEST)}}
 +
 
 +
:{{defend|B6 |A total of 2300 Reports of Adverse Reactions From Pandemrix Vaccine have been reported in Sweden|--[[User:Oluyemitoyinbo|Oluyemitoyinbo]] 12:10, 4 April 2011 (EEST)}} <ref>[http://preventdisease.com/news/09/113009_2300_reports_adverse_reactions_sweden.shtml PreventDisease.com]: Total of 2300 Reports of Adverse Reactions From Pandemrix Vaccine in Sweden</ref>
 +
 
 +
:{{defend|J3 |In Finland, THL decided to stop the use of Pandemrix.|--[[User:Jouni|Jouni]] 23:05, 31 March 2011 (EEST) <ref name="thlstoppandemrix">[http://www.thl.fi/fi_FI/web/fi/uutinen?id=22930 THL recommends to stop the use of Pandemrix]</ref>}}
 +
 
 +
::{{attack invalid|C9 |Kari Välimäki, Chief of staff at the Ministry of Social Affairs and Health, argues, that the suspension of Pandemrix is only a precautionary action, and that there is no doubt that in a similar situation, the same decisions would have been made.|--[[User:Jpmannikko|Jpmannikko]] 16:55, 4 April 2011 (EEST)}}
 +
 
 +
:::{{attack|J4 | This is just a pseudo-objective way of saying that the bad reputation made THL stop the use.|--[[User:Jouni|Jouni]] 18:17, 6 April 2011 (EEST)}}
 +
 
 +
::{{defend|D7 |Although the causal relationship between the Pandemrix vaccine and increased narcolepsy cases is not yet confirmed, THL stopped the vaccinations as a safety measure until the matter can be fully investigated. A potential link between the Pandemrix vaccine and narcolepsy will be investigated in Finland by paedriatic neurologists and THL experts.|--[[User:Minna Ruokolainen|Minna Ruokolainen]] 21:51, 3 April 2011 (EEST)}} <ref name="thl20100825"/>
 +
 
 +
}}
 +
 
 +
{{defend|J6 |Pandemrix should not be used due to precautionary reasons and because there are alternatives.|--[[User:Jouni|Jouni]] 18:17, 6 April 2011 (EEST)}}
 +
 
 +
{{hidden|
 +
 
 +
:{{defend|D8 |The most of the narcolepsy cases in Finland are observed among the children. THL´s decision is far too late and THL should not have used Pandemrix at all or at least for the vaccination of children, because the WHO recommendations for not using the Pandemrix-vaccine for chilred were available before THL launched the vaccination campaing.  |--[[User:Minna Ruokolainen|Minna Ruokolainen]] 21:33, 3 April 2011 (EEST)}} <ref name="rokotusinfoswineflu"/>
 +
 
 +
:{{defend|A5 |As there is presently no swine flu epidemic in Finland, there  is no immediate need for swine flu vaccination|--[[User:Jacob Attipoe|Jacob Attipoe]] 11:18, 1 April 2011 (EEST)}}
 +
 
 +
:{{defend|D3a |The decision to use Pandemrix was probably led by panic and other choices should be considered at this point when narcolepsy cases were identified. |--[[User:Carmen Gil|Carmen Gil]] 11:25, 1 April 2011 (EEST)}}
 +
 
 +
::{{comment|# |This is a valid comment. However, comments do not affect the outcome of a discussion. You might want to develop this into an attack or a defence.|--[[User:Jouni|Jouni]] 07:45, 2 April 2011 (EEST)}}
 +
 
 +
::{{defend|D4 |Finland used a vaccine with adjuvants (Hg and squalene) for whole population, against the recommendation of WHO. WHO recommended that vaccine with adjuvant should not be be used for pregnant women and children because side-effects were not properly known|--[[User:Carmen Gil|Carmen Gil]] 11:25, 1 April 2011 (EEST)}} <ref name="rokotusinfoswineflu"/>
 +
 
 +
:::{{branch|D5 |The lack of scientific-based and reliable information of the effects of adjuvants (and vaccine) caused the public´s lose of confidence in authorities, fear in public and increased the public's opinion against vaccination overall.|--[[User:Carmen Gil|Carmen Gil]] 11:25, 1 April 2011 (EEST)}} <ref name="rokotusinfoswineflu"/>
 +
 
 +
::::{{comment|# |Good usage of branches! However, branches do not affect the outcome of a discussion. You could use this branch also to defend J2 and then it would have an impact on this discussion.|--[[User:Jouni|Jouni]] 07:45, 2 April 2011 (EEST)}}
 +
 
 +
}}
 +
 
 +
{{defend invalid|B8 |There maybe a conflict of interest in the approval of Pandemrix for swine flu vaccination in Finland|--[[User:Oluyemitoyinbo|Oluyemitoyinbo]] 12:50, 4 April 2011 (EEST)}}
 +
 
 +
{{hidden|
 +
 
 +
:{{attack|B11 |According to Chancellor of Justice, Jaakko Jonkka, there's no direct [ evidence to support ] suspicion of bribery but there is a risky situation because the seller funds the buyer.|--[[User:Oluyemitoyinbo|Oluyemitoyinbo]] 12:57, 4 April 2011 (EEST) <ref name="rokotusinfo">[http://www.rokotusinfo.fi/english_html Rokotusinfo]</ref>}}
 +
 
 +
:{{attack|C11 |The World Health Organization (WHO) examined the link between THL and GSK and found no evidence that research funding and the pharmaceutical company would have influenced the choise of vaccines|--[[User:Jpmannikko|Jpmannikko]] 16:51, 4 April 2011 (EEST)}}
 +
 
 +
:{{defend|B9 |Vaccine Department's head at THL, Dr. Terhi Kilpi have a close relationship with GlaxoSmithKline, the manufactural of Pandemrix vaccine. |--[[User:Oluyemitoyinbo|Oluyemitoyinbo]] 12:50, 4 April 2011 (EEST)}} <ref name="rokotusinfo"/>
 +
 
 +
:{{defend|B10 |GlaxoSmithKline has funded several THL's activities with millions of euros.|--[[User:Oluyemitoyinbo|Oluyemitoyinbo]] 12:57, 4 April 2011 (EEST)}}
 +
 
 +
:{{defend|C10 |There have been claims that THL would have had a conflict of interest, as it had received financing worth EUR 6 million from the vaccine producer GalaxoSmithKline (GSK)|--[[User:Jpmannikko|Jpmannikko]] 16:51, 4 April 2011 (EEST)}}
 +
 
 +
}}
  
−
{{defend_invalid|A1 |Even though a nine fold increase in narcolepsy was found in vaccinated population, the occurrence of narcolepsy was still very rare with this apparent increase. A number of different reasons may account for the observed rise in the incidence of narcolepsy namely: A (H1N1) infection, vaccination, combined effect of infection and vaccination, or some other factor entirely. Infections have been documented as causing narcolepsy.|--[[User:Jacob Attipoe|Jacob Attipoe]] 11:18, 1 April 2011 (EEST)}}
+
{{branch|C12 |The interesting question about Pandemrix is perhaps not if it should not be used because of narcolepsy threat, but whether if it was actually needed at all. Russian Federations chief doctor Gennady Onishchenko stated on June 2, 2009 that swine flu was not aggressive enough to cause worldwide pandemic. He noted that the mortality rate of confirmed cases was 1,6% in Mexico and only 0,1% in United States. He also noted that there was 16,000 cases so far when during any flu season some 10,000 people become ill in Moscow alone.|--[[User:Jpmannikko|Jpmannikko]] 19:25, 4 April 2011 (EEST)}}
−
:{{attack|A1 |No similar increase in incidence of narcolepsy is reported in other Nordic countries. Canada has extensively used this type of vaccine with no evidence of increased risk for narcolepsy|--[[User:Jacob Attipoe|Jacob Attipoe]] 11:18, 1 April 2011 (EEST)}}
 
−
{{defend|A2 |as there is presently no swine flu epidemic in Finland, there  is no immediate need for swine flu vaccination|--[[User:Jacob Attipoe|Jacob Attipoe]] 11:18, 1 April 2011 (EEST)}}
 
  
 +
:{{comment|# |Good usage of branch functionalities! However, this is also an attack, because it changes the resolution of the statement away from "accepted".|--[[User:Jouni|Jouni]] 06:55, 6 April 2011 (EEST)}}
  
−
{{attack|1 |Despite risks, Pandemrix is an effective vaccine and has clearly net positive effects in countries where emergency treatment is poorly available for severe swine flu cases.|--[[User:Jouni|Jouni]] 23:05, 31 March 2011 (EEST)}}
+
{{attack invalid|E6 |The vaccination used last year will most likely protect also against the possible swine flu epidemic of this year, although the virus has changed a bit.|--[[User:Sallamari Tynkkynen|Sallamari Tynkkynen]] 10:57, 1 April 2011 (EEST)}} <ref name="thl20101209">[http://www.thl.fi/fi_FI/web/fi/uutinen?id=23692 THL press release 9 Dec 2010]</ref>
  
−
{{defend|2 |The reputation of Pandemrix is globally so poor that it is impossible to use it any more.|--[[User:Jouni|Jouni]] 23:05, 31 March 2011 (EEST)}}
+
:{{attack|J6 |This may be true but what is the connection to the statement? This is irrelevant.|--[[User:Jouni|Jouni]] 08:15, 2 April 2011 (EEST)}}
−
:{{defend_invalid|3 |In Finland, THL decided to stop the use of Pandemrix.|--[[User:Jouni|Jouni]] 23:05, 31 March 2011 (EEST), [http://www.thl.fi/fi_FI/web/fi/uutinen?id{{eq}}22930]}}
 
−
::{{attack|E6 |The vaccination used last year will most likely protect also against the possible swine flu epidemic of this year, although the virus has changed a bit.|--[[User:Sallamari Tynkkynen|Sallamari Tynkkynen]] 10:57, 1 April 2011 (EEST) [http://www.thl.fi/fi_FI/web/fi/uutinen?id{{eq}}23692]}}
 
−
:::{{defend|E7 |Vaccination is a very good method of preventing swine flu infections.|--[[User:Sallamari Tynkkynen|Sallamari Tynkkynen]] 10:59, 1 April 2011 (EEST) [http://www.thl.fi/fi_FI/web/fi/uutinen?id{{eq}}23692]}}
 
−
:::{{defend|E8 |WHO recommended that H1N1 virus strain be included in the seasonal flu vaccines for the 2009/2010 season, because H1N1 is still in circulation, but behaving like a seasonal flu virus. |--[[User:Anna Kokkonen|Anna Kokkonen]] 11:10, 1 April 2011 (EEST) [http://www.ema.europa.eu/ema/index.jsp?curl{{eq}}pages/special_topics/general/general_content_000461.jsp&murl{{eq}}menus/special_topics/special_topics.jsp&mid{{eq}}WC0b01ac05801d7bfe&jsenabled{{eq}}true]}}
 
−
:::{{defend|E9 |The information supplied on the safety and effectiveness of three of the pandemic-influenza vaccines was considered complete enough for the Agency's Committee for Medicinal Products for Human Use  to recommend their use outside a pandemic situation. |--[[User:Anna Kokkonen|Anna Kokkonen]] 11:10, 1 April 2011 (EEST) [http://www.ema.europa.eu/ema/index.jsp?curl{{eq}}pages/special_topics/general/general_content_000461.jsp&murl{{eq}}menus/special_topics/special_topics.jsp&mid{{eq}}WC0b01ac05801d7bfe&jsenabled{{eq}}true]}}
 
  
−
{{attack|E4 |The side effects of Pandemrix have been accentuated, although the benefits are much more significant.|--[[User:Sallamari Tynkkynen|Sallamari Tynkkynen]] 10:50, 1 April 2011 (EEST) [http://www.hs.fi/kotimaa/artikkeli/MTV3+Arkkiatri+moittii+sikainfluenssarokotteen+vastustajia/1135250236010]}}
+
:{{defend|E8 |WHO recommended that H1N1 virus strain be included in the seasonal flu vaccines for the 2009/2010 season, because H1N1 is still in circulation, but behaving like a seasonal flu virus. |--[[User:Anna Kokkonen|Anna Kokkonen]] 11:10, 1 April 2011 (EEST)}} <ref name="emaswineflu"/>
  
−
{{attack|E5 |Nursing staff in hospitals should be vaccinated; it is their responsibility as medical professionals.|--[[User:Sallamari Tynkkynen|Sallamari Tynkkynen]] 10:54, 1 April 2011 (EEST) [http://www.hs.fi/kotimaa/artikkeli/MTV3+Arkkiatri+moittii+sikainfluenssarokotteen+vastustajia/1135250236010]}}
+
{{attack invalid|E5 |Nursing staff in hospitals should be vaccinated; it is their responsibility as medical professionals.|--[[User:Sallamari Tynkkynen|Sallamari Tynkkynen]] 10:54, 1 April 2011 (EEST)}} <ref name="hsarkkiatri"/>
  
−
{{comment|D1 |The decision to use Pandemrix was probably led by panic and other choices should be considered at this point|--[[User:Carmen Gil|Carmen Gil]] 11:25, 1 April 2011 (EEST)}}
+
:{{attack|J7 |This may be true but what is the connection to the statement? Does this actually relate more to E4 than the main statement?|--[[User:Jouni|Jouni]] 08:15, 2 April 2011 (EEST)}}
−
::{{defend|D2 |Finland used a vaccination with additives, against the recommendation of WHO|--[[User:Carmen Gil|Carmen Gil]] 11:25, 1 April 2011 (EEST)}}
 
−
:::{{defend|D3 |Additives can cause flu-like symptoms, increasing the public's opinion against vaccination|--[[User:Carmen Gil|Carmen Gil]] 11:25, 1 April 2011 (EEST)}}
 
  
−
{{attack|D4 |Pandemrix has a lower Hg content than other vaccines (2.5 vs 25 µg), which could cause other neurological problems in children|--[[User:Carmen Gil|Carmen Gil]] 11:25, 1 April 2011 (EEST)}}
 
 
}}
 
}}
  
−
'''Discussion groups:
+
'''Discussion groups ([[DARM]] 2011):
 
* [[Talk:Assessment of the health impacts of H1N1 vaccination/Group A]]
 
* [[Talk:Assessment of the health impacts of H1N1 vaccination/Group A]]
 
* [[Talk:Assessment of the health impacts of H1N1 vaccination/Group B]]
 
* [[Talk:Assessment of the health impacts of H1N1 vaccination/Group B]]
Line 66: Line 254:
 
* [[Talk:Assessment of the health impacts of H1N1 vaccination/Group E]] (Finnish material)
 
* [[Talk:Assessment of the health impacts of H1N1 vaccination/Group E]] (Finnish material)
  
 +
===References===
  
−
'''Additional material:
+
<references/>
−
* [[:File:Swine flu story.ppt]]
 
−
* [[Decision analysis and risk management#See also]]
 

Latest revision as of 14:24, 27 February 2015

Evaluation of the H1N1 assessment

The evaluation was originally made for the purpose of demonstrating the application of the properties of good assessment framework in an article considering evaluation of model and assessment effectiveness, but in the end was omitted from the manuscript. Here the assessment of the health impacts of H1N1 vaccination is evaluated according to the application of the Properties of Good Assessment framework, originally published by Tuomisto and Pohjola (2007). For the purpose of this evaluation, the framework has been slightly updated as is described in Properties of good assessment.

On the course the assessment primarily served the purposes of illustrating essential aspects of decision analysis and risk management, as well as an explicating the swine flu (AH1N1 influenza) pandemic and related vaccination campaign in Finland 2009 - 2010 as examples of practical contexts for decision analysis and risk management. Here we focus on its secondary purpose: to evaluate the decision to launch a nationwide vaccination campaign to alleviate the pandemic in Finland. The discourse erupted during autumn 2010 when suspicions regarding a relationship between the AH1N1 vaccine and the sudden increase in prevalence of narcolepsy in Finland were publicized in the media. Soon after that the National Institute for Health and Welfare (THL) in Finland set up a task force to determine whether such a causal relationship exists (THL, 2011a,b).

The setting for evaluating the assessment:

  • Time of assessment: spring 2011.
  • Assessors: organizers of the DARM course, participants of the course.
  • Intended primary user: Ministry of Social Affairs and Health in Finland.
  • Intended use: basis for communication about public concerns regarding swine flu vaccines and narcolepsy.
  • Evaluation method: qualitative expressions on a 5-point scale from very low to very high.
  • Evaluation focus: whole assessment (main message, supported by all other information).
  • Basis for evaluation: information provided on the assessment page in Opasnet, complemented with additional information obtained from assessment participants where necessary.


Table 2. Evaluation of the assessment of the health impacts of H1N1 vaccination
Category Property Characterization Explanation
Quality of content Informativeness Medium The conclusion that vaccinating whole population was a better alternative than no vaccination is well supported by the model results. The conclusion that vaccinating whole population was a better alternative than vaccinating all except 5-19 old is more vaguely supported. The uncertainty of some variables in the model is high.
Calibration Medium Model results and assessment conclusions are in line with the analyses by the European Medical Agency (EMA, 2011) and the National narcolepsy task force in Finland (THL, 2011b). The calibration of some variables in the model, e.g. DALY weight for narcolepsy, may well be questioned as they are based on assumptions rather than data.
Coherence High The question is well addressed and the answer is reasoned with a model that takes account of the most important factors known to have effect on the outcome. Limitations in the comprehensiveness of the model and its parts exist, e.g. in terms of assumptions, but many of them identified and explicated. Value of information analysis indicates high coherence within the assessment.
Applicability Relevance Very low (potentially high) The assessment addresses an issue that can be considered as underlying much of the discussion regarding the swine flu pandemic and the vaccination campaign. The assessment could thus be claimed to serve a real, existing need and the potential relevance could be considered high. However, in reality there was practically no interaction between the assessors and intended users and there was no demand from the users for the assessors to address the question. Consequently, the actual relevance is very low.
Availability Low (potentially very high) The model was developed and presented on a freely accessible assessment page in Opasnet at a time when many of the issues related to the case were still unresolved and under active public discussion. Practically no technical limits to availability exist. However, awareness about the assessment among intended users remained low despite (or due to only) the minor efforts of informing them by e-mail. Consequently, the relevance is actually low, although potentially very high.
Usability Medium The main message and its basis is presented in a structured way and is relatively easily perceivable even for non-experts. Assumptions and limitations are described and access to the data and calculations is provided and easy. However, obtaining a deeper and detailed understanding of the model requires specific knowledge, detailed scrutiny, and possibly also assistance from the developers. Explication of the intended use and guidance of use are omitted from the assessment (cf. use plans in Vermaas and Houkes, 2006). Due to lack of interaction with users the actual usability in intended use is unknown.
Acceptability Medium The open approach can be considered to have increased acceptability in a situation where authorities were accused for non-warranted withholding of important information. On the other hand the model was developed by non-experts regarding infectious diseases and vaccines. Also the credibility of the organization, THL, that the main developers represented was strongly questioned in public at the time of developing and delivering the model. Due to lack of interaction with users the actual acceptability in intended use is unknown.
Efficiency Intra-assessment efficiency High The assessment was developed as a side product of the DARM course. The development of the model consumed about 2 person months work, consisting mostly of the efforts of the course assistant, a high school graduate with good mathematical and computer skills, but no prior specific expertise on vaccines or infectious diseases.
Inter-assessment efficiency High The assessment is mostly structured as independent variables that are applicable in other assessments. The assessment also applies some variables that were developed in previous assessments. However, the calculation in the model for the most part was not coded as independently applicable modules.
Overall evaluation Effectiveness Low Despite mostly relatively good scores with regard to many properties, the overall effectiveness remains low because the intended use did not take place in reality. The potential for outcome effectiveness can be seen, but the failure of the delivery, i.e. lack of interaction between the assessment and its use, prevents it from becoming realized. The realized impacts are mostly process effects, increasing the knowledge among the participants of the assessment. As many of the participants work in roles that are relevant to the interests of the intended user, the Ministry of Social Affairs and Health, it can be assumed that some of that knowledge will eventually trickle to its intended use, but indirectly and with delay.

The example assessment can be considered as somewhat typical in the sense that it fails to convey its as such good results into practice. Although the evaluation example above can be considered somewhat superficial, and is made only qualitatively, it highlights some important aspects of assessment and model performance:

  1. In terms of outcome effectiveness, there is a major difference between the potential of an assessment or model to deliver its intended outcomes and the actual delivery thereof.
  2. The properties that have been least addressed within the common contemporary approaches to performance, namely relevance and availability, are critical for transforming the potential of an assessment or model to effectiveness.
  3. The delivery of the assessment or model outputs to their intended use is necessary to take account of in considering assessment and model performance.
  4. Improving effectiveness of assessments and models is not an issue to be addressed within the communities of assessment and modelling, but requires simultaneous development of the use processes and the capacity of policy making to make use of what assessments and models can deliver.

The major limitations of the assessment indicated by the evaluation according to the properties of good assessment may seem apparent, but they would probably not show up in evaluations applying more conventional approaches. Altogether, the example shows that, despite still lacking explicit methods for its application, the Properties of Good Assessment framework can already be a useful and powerful means for evaluating and managing assessment and model performance.

References

EMA, 2011. Press release 27 July 2011: European Medicines Agency recommends restricting use of Pandemrix. European Medicines Agency. Available: http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2011/07/WC500109182.pdf

THL, 2011a. National narcolepsy task force interim report 31 January 2011. National Institute for Health and Welfare (THL), Helsinki. Available: http://www.thl.fi/thl-client/pdfs/dce182fb-651e-48a1-b018-3f774d6d1875

THL, 2011b. National narcolepsy task force final report 31 August 2011 (in Finnish). National Institute for Health and Welfare (THL), Helsinki. Available: http://www.thl.fi/thl-client/pdfs/c02a3788-a691-47a4-bca8-5161b6cff077

Vermaas, P.E., Houkes, W., 2006. Technical functions: a drawbridge between the intentional and structural natures of technical artefacts. Studies in History and Philosophy of Science 37, 5-18.

Pandemrix should not be used because of narcolepsy risk

Instructions for the exercise 4 of Darm course 2011 can be found here

How to read discussions

Statements: Pandemrix should not be used any more anywhere because its narcolepsy risk is too high.

Resolution: Not accepted. Pandemrix is still an effective and safe vaccine. However, due to precautionary reasons, other alternatives should be used when available, because the occurrence of narcolepsy is not understood.

(Resolved, i.e., the resolution has been updated to the main page.)

Argumentation:

⇤J5 : Pandemrix is a safe vaccine and narcolepsy risk is low. --Jouni 18:17, 6 April 2011 (EEST)



⇤J5 : Pandemrix is an effective vaccine with strong benefits. --Jouni 18:17, 6 April 2011 (EEST)

←B4 : Adjuvanted vaccines commonly provide a stronger immune response than unadjuvanted vaccines and also provide a broader immune response allowing for some potential drift of the influenza virus (Pandemrix is an adjuvanted vaccine). --Oluyemitoyinbo 11:12, 1 April 2011 (EEST) [4]
←B5 : A positive effect of the vaccine can be felt from pregnant women, it gives immunization to the mother-to-be and the new born that is not eligible for vaccination until the age of six months. The adverse events reported so far have mainly been symptoms such as fever, nausea, headache, allergic reactions and injection site reactions, confirming the safety profile of the vaccine. The vaccine can even be given to breastfeeding mothers and this will reduce the chance that the infant will get influenza. --Oluyemitoyinbo 11:20, 1 April 2011 (EEST) [4]
←E7 : Vaccination is a very good method of preventing swine flu infections. --Sallamari Tynkkynen 10:59, 1 April 2011 (EEST) [5]

⇤D3b : The vaccine may still have been used where no other option was available and upon consideration in individual cases, for instance for people travelling to areas where an epidemic was in progress. --Carmen Gil 11:25, 1 April 2011 (EEST) [6]

⇤J1 Despite risks, Pandemrix is an effective vaccine and has clearly net positive effects in countries where emergency treatment is poorly available for severe swine flu cases. --Jouni 23:05, 31 March 2011 (EEST)



←J2 The reputation of Pandemrix is globally so poor that it is impossible to use it any more. --Jouni 23:05, 31 March 2011 (EEST)



←J6 : Pandemrix should not be used due to precautionary reasons and because there are alternatives. --Jouni 18:17, 6 April 2011 (EEST)



←B8 There maybe a conflict of interest in the approval of Pandemrix for swine flu vaccination in Finland --Oluyemitoyinbo 12:50, 4 April 2011 (EEST)



→C12 : The interesting question about Pandemrix is perhaps not if it should not be used because of narcolepsy threat, but whether if it was actually needed at all. Russian Federations chief doctor Gennady Onishchenko stated on June 2, 2009 that swine flu was not aggressive enough to cause worldwide pandemic. He noted that the mortality rate of confirmed cases was 1,6% in Mexico and only 0,1% in United States. He also noted that there was 16,000 cases so far when during any flu season some 10,000 people become ill in Moscow alone. --Jpmannikko 19:25, 4 April 2011 (EEST)

--# : Good usage of branch functionalities! However, this is also an attack, because it changes the resolution of the statement away from "accepted". --Jouni 06:55, 6 April 2011 (EEST)

⇤E6 The vaccination used last year will most likely protect also against the possible swine flu epidemic of this year, although the virus has changed a bit. --Sallamari Tynkkynen 10:57, 1 April 2011 (EEST) [5]

⇤J6 : This may be true but what is the connection to the statement? This is irrelevant. --Jouni 08:15, 2 April 2011 (EEST)
←E8 : WHO recommended that H1N1 virus strain be included in the seasonal flu vaccines for the 2009/2010 season, because H1N1 is still in circulation, but behaving like a seasonal flu virus. --Anna Kokkonen 11:10, 1 April 2011 (EEST) [10]

⇤E5 Nursing staff in hospitals should be vaccinated; it is their responsibility as medical professionals. --Sallamari Tynkkynen 10:54, 1 April 2011 (EEST) [7]

⇤J7 : This may be true but what is the connection to the statement? Does this actually relate more to E4 than the main statement? --Jouni 08:15, 2 April 2011 (EEST)


Discussion groups (DARM 2011):

References

  1. ↑ 1.0 1.1 1.2 1.3 Rokotusinfo: Swine flu
  2. ↑ YLE: EU agency does not find link between Pandemrix and narcolepsy
  3. ↑ 3.0 3.1 3.2 Rokotusinfo
  4. ↑ 4.0 4.1 4.2 European Centre for Disease Prevention and Control (ECDC): Questions and answers
  5. ↑ 5.0 5.1 THL press release 9 Dec 2010
  6. ↑ 6.0 6.1 6.2 6.3 THL press release 25 Aug 2010
  7. ↑ 7.0 7.1 Helsingin Sanomat: Arkkiatri moittii sikainfluenssarokotteen vastustajia (in Finnish)
  8. ↑ WHO Europe: Pandemrix® vaccine and increased risk of narcolepsy
  9. ↑ WHO Global Advisory Committee on Vaccine Safety: Statement on narcolepsy and vaccination
  10. ↑ 10.0 10.1 European Medicines Agency (EMA): Information page on Swine flu
  11. ↑ PreventDisease.com: Total of 2300 Reports of Adverse Reactions From Pandemrix Vaccine in Sweden
  12. ↑ THL recommends to stop the use of Pandemrix
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