Narcolepsy and swine flu: conflicts of interest in Finnish investigation

Media release 2010-10-28: Narcolepsy and swine flu: Conflicts of interest in Finnish research

Rokotusinfo ry, Helsinki, Finland

The swine flu vaccine Pandemrix is suspected to be the cause of
narcolepsy in 36 Finnish children. The cases have been reported in
less than a year’s time. In earlier years, only on estimatated average of
three (3) children in a a year have been diagnosed with narcolepsy.

According to Finnish citizen’s group, non-profit NGO Rokotusinfo ry,
the Finnish research to find out whether the Pandemrix swine flu
vaccine causes narcolepsy in children has conflict of interest issues
and prejudice.

The Finnish work to research the possibility of causal relation
between the adjuvanted swine flu vaccine and narcolepsy consists of a
register study and one clinical trial.

The Finnish governmental research institute THL is carrying out a
trial worth more than 10 million euros under contract by Pandemrix
manufacturer GlaxoSmithKline. At the same time it is carrying out
the studies to investigate whether Pandemrix is the cause of
narcolepsy.

According to THL, the chief responsible person is the same in both
trials – head of THL’s vaccine department, professor Terhi Kilpi.

“- THL’s vaccine department has also very strongly recommended the
swine fly vaccine and had a key role in acquiring the vaccine for
Finland. The conflicts of interest are grave and obvious”, says Jyrki Kuoppala,
chairman of Rokotusinfo.

According to Rokotusinfo, THL also exhibits a prejudice regarding the
possible causal association between Pandemrix and narcolepsy. On their web
site, THL has a Q&A section where there’s the question “Has the swine flu vaccine
really increased the number of narcolepsy cases?” and THL’s answer is
“The connection is only temporal”. (1)

“The answer is mind-boggling – it looks like the outcome has been
decided even before the research has started”, comments Rokotusinfo’s
chairman Kuoppala.

On their web pages and Finnish media THL has estimated the causal
relation between Pandemrix and narcolepsy as improbable, mainly based
on the fact that most reports of narcolepsy after vaccination have
come from Finland and Sweden.

According to Rokotusinfo’s Kuoppala, this line of reasoning neglects
the fact that it was mainly exactly these Nordic countries which
broadly used the adjuvanted vaccine, even in vulnerable groups like
pregnant women and children. In many other countries, another type of
vaccine was used for vulnerable groups.  There are also big
differences in vaccine coverage – in many other countries, the vaccine
coverage was 10% or less, while according to THL, 80 % of Finnish
children received the vaccine.

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Differences in vaccine-related narcolepsy

According to Rokotusinfo, there are differences in the narcolepsy cases report after vaccination and earlier narcolepsy cases.

“Parents whose children have fallen in have told us they think it’s
important to study all symptoms the children have – the parents’
account is that there are differences to earlier narcolepsy cases”,
says Rokotusinfo’s chairman Jyrki Kuoppala.

Narcolepsy has presented itself in younger age groups than
earlier. Even four year olds have been fallen ill in some European
countries and as young as five years in Finland (2). Narcolepsy also
has advanced more quickly than before.

Rokotusinfo ry stresses that there must be sufficient research into the cases so the children can get help.

“THL’s research concerns the evaluation of possible causal relation. Other parties do the research aimed to help the children,
and these might need extra resources. It’s important that independent investigation is possible.”, says Rokotusinfo’s Kuoppala.
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For more information: Rokotusinfo ry, http://www.rokotusinfo.fi / http://www.rokotusinfo.fi/english_html
rokotusinfo@rokotusinfo.fi
tel. +358 50 572 2062

(1) THL: Q & A on narcolepsy and swine flu vaccine, http://www.thl.fi/fi_FI/web/fi/sikainfluenssa/usein_kysyttya/narkolepsia_ja_sikainfluenssarokote

(2) European Medicines Agency updates on the review of Pandemrix and reports of narcolepsy
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2010/09/news_detail_001120.jsp&murl=menu