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Swine flu jab link
to killer nerve disease: Leaked letter reveals
concern of neurologists over 25 deaths in America
Prevention: Is
the swine flu jab safe?
A warning that
the new swine flu jab is linked to a deadly nerve
disease has been sent by the Government to senior
neurologists in a confidential letter.
The letter from
the Health Protection Agency, the official body that
oversees public health, has been leaked to The Mail
on Sunday, leading to demands to know why the
information has not been given to the public before
the vaccination of millions of people, including
children, begins.
It tells the
neurologists that they must be alert for an increase
in a brain disorder called Guillain-Barre Syndrome (GBS),
which could be triggered by the vaccine.
GBS attacks the
lining of the nerves, causing paralysis and
inability to breathe, and can be fatal.
The letter,
sent to about 600 neurologists on July 29, is the
first sign that there is concern at the highest
levels that the vaccine itself could cause serious
complications.
It refers to
the use of a similar swine flu vaccine in the United
States in 1976 when:
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More people
died from the vaccination than from swine flu.
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500 cases of
GBS were detected.
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The vaccine
may have increased the risk of contracting GBS
by eight times.
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The vaccine
was withdrawn after just ten weeks when the link
with GBS became clear.
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The US
Government was forced to pay out millions of
dollars to those affected.
Concerns have
already been raised that the new vaccine has not
been sufficiently tested and that the effects,
especially on children, are unknown.
It is being
developed by pharmaceutical companies and will be
given to about 13million people during the first
wave of immunisation, expected to start in October.
Top priority
will be given to everyone aged six months to 65 with
an underlying health problem, pregnant women and
health professionals.
The British
Neurological Surveillance Unit (BNSU), part of the
British Association of Neurologists, has been asked
to monitor closely any cases of GBS as the vaccine
is rolled out.
One senior
neurologist said last night: ‘I would not have the
swine
flu jab because of the GBS risk.’
There are
concerns that there could be a repeat of what became
known as the ‘1976 debacle’ in the US, where a swine
flu vaccine killed 25 people – more than the virus
itself.
A mass
vaccination was given the go-ahead by President
Gerald Ford because scientists believed that the
swine flu strain was similar to the one responsible
for the 1918-19 pandemic, which killed half a
million Americans and 20million people worldwide.
The swine flu
vaccine being offered to children has not been
tested on infants
Within days,
symptoms of GBS were reported among those who had
been immunised and 25 people died from respiratory
failure after severe paralysis. One in 80,000 people
came down with the condition. In contrast, just one
person died of swine flu.
More than
40million Americans had received the vaccine by the
time the programme was stopped after ten weeks. The
US Government paid out millions of dollars in
compensation to those affected.
The swine flu
virus in the new vaccine is a slightly different
strain from the 1976 virus, but the possibility of
an increased incidence of GBS remains a concern.
Shadow health
spokesman
Mike Penning
said last night: ‘The last thing we want is secret
letters handed around experts within the NHS. We
need a vaccine but we also need to know about
potential risks.
‘Our job is to
make sure that the public knows what’s going on. Why
is the Government not being open about this? It’s
also very worrying if GPs, who will be administering
the vaccine, aren’t being warned.’
Two letters
were posted together to neurologists advising them
of the concerns. The first, dated July 29, was
written by Professor Elizabeth Miller, head of the
HPA’s Immunisation Department.
It says: ‘The
vaccines used to combat an expected swine influenza
pandemic in 1976 were shown to be associated with
GBS and were withdrawn from use.
‘GBS has been
identified as a condition needing enhanced
surveillance when the swine flu vaccines are rolled
out.
‘Reporting
every case of GBS irrespective of vaccination or
disease history is essential for conducting robust
epidemiological analyses capable of identifying
whether there is an increased risk of GBS in defined
time periods after vaccination, or after influenza
itself, compared with the background risk.’
The second
letter, dated July 27, is from the Association of
British Neurologists and is written by Dr Rustam Al-Shahi
Salman, chair of its surveillance unit, and
Professor Patrick Chinnery, chair of its clinical
research committee.
Halted: The
1976 US swine flu campaign
It says:
‘Traditionally, the BNSU has monitored rare diseases
for long periods of time. However, the swine
influenza (H1N1) pandemic has overtaken us and we
need every member’s involvement with a new BNSU
survey of Guillain-Barre Syndrome that will start on
August 1 and run for approximately nine months.
‘Following the
1976 programme of vaccination against swine
influenza in the US, a retrospective study found a
possible eight-fold increase in the incidence of GBS.
‘Active
prospective ascertainment of every case of GBS in
the UK is required. Please tell BNSU about every
case.
‘You will have
seen Press coverage describing the Government’s
concern about releasing a vaccine of unknown
safety.’
If there are
signs of a rise in GBS after the vaccination
programme begins, the Government could decide to
halt it.
GBS attacks the
lining of the nerves, leaving them unable to
transmit signals to muscles effectively.
It can cause
partial paralysis and mostly affects the hands and
feet. In serious cases, patients need to be kept on
a ventilator, but it can be fatal.
Death is caused
by paralysis of the respiratory system, causing the
victim to suffocate.
It is not known exactly what causes GBS and research
on the subject has been inconclusive.
However, it is
thought that one in a million people who have a
seasonal flu vaccination could be at risk and it has
also been linked to people recovering from a bout of
flu of any sort.
The HPA said it
was part of the Government’s pandemic plan to
monitor GBS cases in the event of a mass vaccination
campaign, regardless of the strain of flu involved.
But vaccine experts warned that the letters proved
the programme was a ‘guinea-pig trial’.
Dr Tom
Jefferson, co-ordinator of the vaccines section of
the influential Cochrane Collaboration, an
independent group that reviews research, said: ‘New
vaccines never behave in the way you expect them to.
It may be that there is a link to GBS, which is
certainly not something I would wish on anybody.
‘But it could
end up being anything because one of the additives
in one of the vaccines is a substance called
squalene, and none of the studies we’ve extracted
have any research on it at all.’
He said
squalene, a naturally occurring enzyme, could
potentially cause so-far-undiscovered side effects.
Jackie
Fletcher, founder of vaccine support group Jabs,
said: ‘The Government would not be anticipating this
if they didn’t think there was a connection. What
we’ve got is a massive guinea-pig trial.’
Professor
Chinnery said: ‘During the last swine flu pandemic,
it was observed that there was an increased
frequency of cases of GBS. No one knows whether it
was the virus or the vaccine that caused this.
‘The purpose of
the survey is for us to assess rapidly whether there
is an increase in the frequency of GBS when the
vaccine is released in the UK. It also increases
consultants’ awareness of the condition.
Panic over? The
number of swine flu cases has fallen sharply in the
past few weeks
‘This is a
belt-and-braces approach to safety and is not
something people should be substantially worried
about as it’s a rare condition.’
If neurologists
do identify a case of GBS, it will be logged on a
central database.
Details about
patients, including blood samples, will be collected
and monitored by the HPA.
It is hoped
this will help scientists establish why some people
develop the condition and whether it is directly
related to the vaccine.
But some
question why there needs to be a vaccine, given the
risks. Dr Richard Halvorsen, author of The Truth
About Vaccines, said: ‘For people with serious
underlying health problems, the risk of dying from
swine flu is probably greater than the risk of side
effects from the vaccine.
‘But it would
be tragic if we repeated the US example and ended up
with more casualties from the jabs.
‘I applaud the
Government for recognising the risk but in most
cases this is a mild virus which needs a few days in
bed. I’d question why we need a vaccine at all.’
Professor
Miller at the HPA said: ‘This monitoring system
activates pandemic plans that have been in place for
a number of years. We’ll be able to get information
on whether a patient has had a prior influenza
illness and will look at whether influenza itself is
linked to GBS.
‘We are not
expecting a link to the vaccine but a link to
disease, which would make having the vaccine even
more important.’
The UK’s
medicines watchdog, the Medicines and Healthcare
Products Regulatory Agency, is already monitoring
reported side effects from Tamiflu and Relenza and
it is set to extend that surveillance to the
vaccine.
A Department of
Health spokesperson said: ‘The European Medicines
Agency has strict processes in place for licensing
pandemic vaccines.
‘In preparing
for a pandemic, appropriate trials to assess safety
and the immune responses have been carried out on
vaccines very similar to the swine flu vaccine. The
vaccines have been shown to have a good safety
profile.
‘It is
extremely irresponsible to suggest that the UK would
use a vaccine without careful consideration of
safety issues. The UK has one of the most successful
immunisation programmes in the world.’
I COULDN''T EAT OR
SPEAK... IT WAS HORRENDOUS
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Victim: Hilary Wilkinson spent three
months in hospital after she was
diagnosed with Guillain-Barre Syndrome
When Hilary Wilkinson woke up with
muscle weakness in her left arm and
difficulty breathing, doctors initially
put it down to a stroke.
But
within hours, she was on a ventilator in
intensive care after being diagnosed with
Guillain-Barre Syndrome.
She
spent three months in hospital and had to
learn how to talk and walk again. But at
times, when she was being fed through a drip
and needed a tracheotomy just to breathe,
she doubted whether she would survive.
The
mother of two, 57, from
Maryport,
Cumbria, had been in good health until she
developed a chest infection in March 2006.
She gradually became so weak she could not
walk downstairs.
Doctors did not diagnose Guillain-Barre
until her condition worsened in hospital and
tests showed her reflexes slowing down. It
is impossible for doctors to know how she
contracted the disorder, although it is
thought to be linked to some infections. |
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Mrs Wilkinson
said: ‘It was very scary. I couldn’t eat and I
couldn’t speak. My arms and feet had no strength and
breathing was hard.
I was treated
with immunoglobulin, which are proteins found in
blood, to stop damage to my nerves. After ten days,
I still couldn’t speak and had to mime to nurses or
my family.
‘It was
absolutely horrendous and I had no idea whether I
would get through it. You reach very dark moments at
such times and wonder how long it can last.
But I’m a very
determined person and I had lots of support.’
After three
weeks, she was transferred to a neurological ward,
where she had an MRI scan and nerve tests to assess
the extent of the damage.
Still unable to
speak and in a wheelchair, Mrs Wilkinson eventually
began gruelling physiotherapy to improve her muscle
strength and movement but it was exhausting and
painful.
Three years
later, she is almost fully recovered. She can now
walk for several miles at a time, has been abroad
and carries out voluntary work for a GBS Support
Group helpline.
She said: ‘It
makes me feel wary that the Government is rolling
out this vaccine without any clear idea of the GBS
risk, if any. I wouldn’t wish it on anyone and it
certainly changed my life.
‘I’m
frightened to have the swine flu vaccine if this
might happen again – it’s a frightening illness and
I think more research needs to be done on the effect
of the vaccine.’
Hotline staff given access to confidential records
Confidential NHS staff records and disciplinary
complaints could be accessed by hundreds of workers
manning the Government’s special swine flu hotline.
They were able
to browse through a database of emails containing
doctors’ and nurses’ National Insurance numbers,
home addresses, dates of birth, mobile phone numbers
and scanned passport pages – all details that could
be used fraudulently.
And private and
confidential complaints sent by hospitals about
temporary medical staff – some of whom were named –
were also made available to the call-centre workers,
who were given a special password to log in to an
internal NHS website.
It could be a
breach of the Data Protection Act.
The hotline
staff work for NHS Professionals, which was set up
using taxpayers’ money to employ temporary medical
and administrative staff for the health service.
The
not-for-profit company runs two of the Government’s
swine flu call centres – with 300 staff in
Farnborough, Hampshire, and 900 in Watford,
Hertfordshire.
Shadow Health
Secretary
Andrew Lansley
described the revelations as ‘disturbing’.
Anne Mitchell,
a spokeswoman for Unison, said: ‘There’s no excuse
for such a fundamental breach of personal security.
Action needs to be taken as soon as possible to make
sure this does not happen again.’
A spokeswoman
for NHS Professionals would not confirm whether
access to the confidential files had been granted.
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