They usually get away (scot-free) with damaging the public with dodgy, ineffective, defective and dangerous drugs and vaccines..
They’ve been doing it for decades…
and they almost always get away with it…
Insight: Evidence grows for narcolepsy link to GSK swine flu shot
(Reuters) – Emelie Olsson is plagued by hallucinations and nightmares. When she wakes up, she’s often paralyzed, unable to breathe properly or call for help. During the day she can barely stay awake, and often misses school or having fun with friends. She is only 14, but at times she has wondered if her life is worth living.
Emelie is one of around 800 children in Sweden and elsewhere in Europe who developed narcolepsy, an incurable sleep disorder, after being immunized with the Pandemrix H1N1 swine flu vaccine made by British drugmaker GlaxoSmithKline in 2009.
Finland, Norway, Ireland and France have seen spikes in narcolepsy cases, too, and people familiar with the results of a soon-to-be-published study in Britain have told Reuters it will show a similar pattern in children there.
Their fate, coping with an illness that all but destroys normal life, is developing into what the health official who coordinated Sweden’s vaccination campaign calls a “medical tragedy” that will demand rising scientific and medical attention.
Europe’s drugs regulator has ruled Pandemrix should no longer be used in people aged under 20. The chief medical officer at GSK’s vaccines division, Norman Begg, says his firm views the issue extremely seriously and is “absolutely committed to getting to the bottom of this”, but adds there is not yet enough data or evidence to suggest a causal link.
Others – including Emmanuel Mignot, one of the world’s leading experts on narcolepsy, who is being funded by GSK to investigate further – agree more research is needed but say the evidence is already clearly pointing in one direction.
“There’s no doubt in my mind whatsoever that Pandemrix increased the occurrence of narcolepsy onset in children in some countries – and probably in most countries,” says Mignot, a specialist in the sleep disorder at Stanford University in the United States.
30 MILLION RECEIVED PANDEMRIX
In total, the GSK shot was given to more than 30 million people in 47 countries during the 2009-2010 H1N1 swine flu pandemic. Because it contains an adjuvant, or booster, it was not used in the United States because drug regulators there are wary of adjuvanted vaccines.
GSK says 795 people across Europe have reported developing narcolepsy since the vaccine’s use began in 2009.
Questions about how the narcolepsy cases are linked to Pandemrix, what the triggers and biological mechanisms might have been, and whether there might be a genetic susceptibility are currently the subject of deep scientific investigation.
But experts on all sides are wary. Rare adverse reactions can swiftly develop into “vaccine scares” that spiral out of proportion and cast what one of Europe’s top flu experts calls a “long shadow” over public confidence in vaccines that control potential killers like measles and polio.
“No-one wants to be the next Wakefield,” said Mignot, referring to the now discredited British doctor Andrew Wakefield who sparked a decades-long backlash against the measles, mumps and rubella (MMR) shot with false claims of links to autism.
With the narcolepsy studies, there is no suggestion that the findings are the work of one rogue doctor.
Independent teams of scientists have published peer-reviewed studies from Sweden, Finland and Ireland showing the risk of developing narcolepsy after the 2009-2010 immunization campaign was between seven and 13 times higher for children who had Pandemrix than for their unvaccinated peers.
“We really do want to get to the bottom of this. It’s not in anyone’s interests if there is a safety issue that needs to be addressed,” said GSK’s Begg.
Emelie’s parents, Charles and Marie Olsson, say she was a top student who loved playing the piano, taking tennis lessons, creating art and having fun with friends. But her life started to change in early 2010, a few months after she had Pandemrix. In the spring of 2010, they noticed she was often tired, needing to sleep when she came home from school.
But it wasn’t until May, when she began collapsing at school, that it became clear something serious was happening.
As well as the life-limiting bouts of daytime sleepiness, narcolepsy brings nightmares, hallucinations, sleep paralysis and episodes of cataplexy – when strong emotions trigger a sudden and dramatic loss of muscle strength.
In Emelie’s case, having fun is the emotional trigger. “I can’t laugh or joke about with my friends any more, because when I do I get cataplexies and collapse,” she said in an interview at her home in the Swedish capital.
Narcolepsy is estimated to affect between 200 and 500 people per million and is a lifelong condition. It has no known cure and scientists don’t really know what causes it. But they do know patients have a deficit of a brain neurotransmitter called orexin, also known as hypocretin, which regulates wakefulness.
Research has found that some people are born with a variant in a gene known as HLA that means they have low hypocretin, making them more susceptible to narcolepsy. Around 25 percent of Europeans are thought to have this genetic vulnerability.
When results of Emelie’s hypocretin test came back in November last year, it showed she had 15 percent of the normal amount, typical of heavy narcolepsy with cataplexy.
The seriousness of her strange new illness has forced her to contemplate life far more than many other young teens: “In the beginning I didn’t really want to live any more, but now I have learned to handle things better,” she said.
Scientists investigating these cases are looking in detail at Pandemrix’s adjuvant, called AS03, for clues.
Some suggest AS03, or maybe its boosting effect, or even the H1N1 flu itself, may have triggered the onset of narcolepsy in those who have the susceptible HLA gene variant.
Angus Nicoll, a flu expert at the European Centre for Disease Prevention and Control (ECDC), says genes may well play a part, but don’t tell the whole story.
“Yes, there’s a genetic predisposition to this condition, but that alone cannot explain these cases,” he said. “There was also something to do with receiving this specific vaccination. Whether it was the vaccine plus the genetic disposition alone or a third factor as well – like another infection – we simply do not know yet.”
GSK is funding a study in Canada, where its adjuvanted vaccine Arepanrix, similar to Pandemrix, was used during the 2009-2010 pandemic. The study won’t be completed until 2014, and some experts fear it may not shed much light since the vaccines were similar but not precisely the same.
It all leaves this investigation with far more questions than answers, and a lot more research ahead.
WAS IT WORTH IT?
In his glass-topped office building overlooking the Maria Magdalena church in Stockholm, Goran Stiernstedt, a doctor turned public health official, has spent many difficult hours going over what happened in his country during the swine flu pandemic, wondering if things should have been different.
“The big question is was it worth it? And retrospectively I have to say it was not,” he told Reuters in an interview.
Being a wealthy country, Sweden was at the front of the queue for pandemic vaccines. It got Pandemrix from GSK almost as soon as it was available, and a nationwide campaign got uptake of the vaccine to 59 percent, meaning around 5 million people got the shot.
Stiernstedt, director for health and social care at the Swedish Association of Local Authorities and Regions, helped coordinate the vaccination campaign across Sweden’s 21 regions.
The World Health Organisation (WHO) says the 2009-2010 pandemic killed 18,500 people, although a study last year said that total might be up to 15 times higher.
While estimates vary, Stiernstedt says Sweden’s mass vaccination saved between 30 and 60 people from swine flu death. Yet since the pandemic ended, more than 200 cases of narcolepsy have been reported in Sweden.
With hindsight, this risk-benefit balance is unacceptable. “This is a medical tragedy,” he said. “Hundreds of young people have had their lives almost destroyed.”
PANDEMICS ARE EMERGENCIES
Yet the problem with risk-benefit analyses is that they often look radically different when the world is facing a pandemic with the potential to wipe out millions than they do when it has emerged relatively unscathed from one, like H1N1, which turned out to be much milder than first feared.
David Salisbury, the British government’s director of immunization, says “therein lies the risk, and the difficulty, of working in public health” when a viral emergency hits.
“In the event of a severe pandemic, the risk of death is far higher than the risk of narcolepsy,” he told Reuters. “If we spent longer developing and testing the vaccine on very large numbers of people and waited to see whether any of them developed narcolepsy, much of the population might be dead.”
Pandemrix was authorized by European drug regulators using a so-called “mock-up procedure” that allows a vaccine to be authorized ahead of a possible pandemic using another flu strain. In Pandemrix’s case, the substitute was H5N1 bird flu.
When the WHO declared a pandemic, GSK replaced the mock-up’s strain with the pandemic-causing H1N1 strain to form Pandemrix.
GSK says the final H1N1 version was tested in trials involving around 3,600 patients, including children, adolescents, adults and the elderly, before it was rolled out.
The ECDC’s Nicoll says early warning systems that give a more accurate analysis of a flu strain’s threat are the best way to minimize risks of this kind of tragedy happening in future.
Salisbury agrees, and says progress towards a universal flu vaccine – one that wouldn’t need last-minute changes made when a new strain emerged – would cuts risks further.
“Ideally, we would have a better vaccine that would work against all strains of influenza and we wouldn’t need to worry about this ever again,” he said. “But that’s a long way off.”
With scientists facing years of investigation and research, Emelie just wants to make the best of her life.
She reluctantly accepts that to do so, she needs a cocktail of drugs to try to control the narcolepsy symptoms. The stimulant Ritalin and the sleeping pill Sobril are prescribed for Emelie’s daytime sleepiness and night terrors. Then there’s Prozac to try to stabilize her and limit her cataplexies.
“That’s one of the things that makes me feel most uncomfortable,” she explains. “Before I got this condition I didn’t take any pills, and now I have to take lots – maybe for the rest of my life. It’s not good to take so many medicines, especially when you know they have side effects.”
(This story has been corrected to insert full name in first paragraph)
Terrifying hallucinations, aggressive behaviour, and threats of self-harm – the nightmare of narcolepsy has devastated the life of Dublin schoolboy Alexander Donovan.
The nine-year-old must take a 20-minute nap in school each morning at 10am, and another 30-minute doze in the afternoon when he returns to the family home in Rathgar.
This is despite the strong medication which his mother, Mairead Lawless, says, is actually licensed for use by adults, but which is crucial to keep Alex alert in the mornings, and provide the deep night-sleep denied him by his debilitating condition.
“It’s a struggle to keep him awake enough to do his homework.He struggles to concentrate and focus, and finds it difficult to pay attention in school. He can be very bad-tempered when he’s tired and he’s a very different child to what he was.”
Her son, she says, can no longer find the energy for the sports he once adored – while other boys of his age are out kicking footballs and getting into mischief, his mother says all Alex wants to do is sit on the sofa.
Once an active, outgoing child, who was full of energy and had lots of friends, Alexander has become quiet, lacking in energy and unable to participate in activities with his pals.
He pushes himself to do Cub Scouts and plays hockey once a week at school, says his mum, but it’s a major effort.
“He cannot go on public transport on his own – he has to be with someone or he will fall asleep,” she reveals.
Alex was just five years old when he received the Pandemrix vaccine (for swine flu) in January 2010. His mother, father Ray and older sister Eleanor were also vaccinated.
About three months later, at the beginning of April, Lawless, a bank manager, started to notice that Alex was falling asleep at odd times – even on very short car journeys.
She brought him to the family GP. Blood tests showed only a slightly lowered iron and white blood cell count.
By mid-May there was no improvement.
Still falling asleep at peculiar times, Alex was now also enduring horrifying nightmares. “He became very scared of the dark and said he was seeing things – and it started to get a bit scary.
“He was sleeping for up to three hours in the afternoon after coming home from school. He’d become very aggressive and irrational after waking up. Sometimes he’d start screaming while sleeping – but his eyes would be open,” she recalls.
Alex, she says, repeatedly asked her why she couldn’t see the terrifying things he was seeing.
“I became afraid that he had psychological issues,” Lawless recalls. “He was seeing things that I could not see and became angry when I couldn’t see them.”
She later discovered that her child was having what are called hypnogogic hallucinations which is a symptom of narcolepsy.
“You’re effectively awake, but still dreaming and not distinguishing between dream and reality,” Lawless explains.
More consultations and tests followed, but by February 2011 Alex put on a lot of weight – another symptom of narcolepsy as Lawless was to discover.
A formerly slim child, Alex, now aged nearly six, was wearing trousers for a nine-year-old.
At one point Lawless did suggest the possibility that Alex had narcolepsy but was told that this was extremely rare in children and that she should rule it out.
The tests continued, but nothing showed up.
Then, in February 2011 Alex started to talk about self-harm. “I was finding red marks down his arm, where he’d been scratching his nails along the inside of his arms.”
One day after he had misbehaved, she put him on ‘time-out’ and instructed him to sit on the bottom step of the stairs:
“He said he didn’t want to be alive anymore and was very distressed – he said that he wanted to strangle himself.”
His energy levels plummeted. “He had to give up the Gaelic football, because he was too tired and emotional for it – and he was not able to play games with his friends. It was an horrific time,” she says.
“Alex was acting so out of character that we knew there was something going on. At times he’d have been behaving like somebody possessed; he was so aggressive, argumentative and irrational in the afternoons.
“This was a complete change from the gentle, placid and happy child he used to be.”
Then, in March 2011 the breakthrough came – another mother showed Lawless a newspaper article about a girl who seemed to be displaying similar symptoms.
“My hair stood up on end,” she recalls. “The article was about a girl who had all of the same symptoms as Alex – falling asleep, nightmares and so on.”
Things moved very quickly after that – following more tests Alex was officially diagnosed with narcolepsy in August 2011.
“Soon afterwards we got in touch with other children who had had the vaccine, and they all had symptoms like Alex and they were getting a diagnosis of narcolepsy.”
In 2011, Lawless joined other parents in establishing the organisation SOUND, (Sufferers of Unique Narcolepsy Disorder) which supports families affected by narcolepsy and also received the Pandemrix vaccine. There are currently more than 60 such families in the group.
It’s now believed more than 70 children in Ireland developed narcolepsy after receiving the swine flu vaccine.
Sound has four members who were adults when vaccinated, says Lawless. “Adults have also been affected although so far the numbers making themselves known to Sound are small in comparison with the number of children to date.”
The group successfully campaigned for supports to be put in place for the affected children, though Lawless emphasises, these are on a temporary basis.
“We got a number of supports put in place for the children and adults – these include discretionary medical cards which can be reviewed annually, as well as expenses for narcolepsy-related medical expenses.”
The medication is very expensive – the night-time medication alone can cost up to €25,000 a year, she says.
“In addition to that, we organised for the children attending to be assessed for education needs – there is now an allowance for extra tuition,” she says.
“Our children have a life-long condition which not only affects their childhood but will affect their work and study for the rest of their lives.”
Health Minister James Reilly recently detailed the services being provided to people with narcolepsy following pandemic vaccination, but Lawless says these have not yet been confirmed to SOUND as permanent supports: “These are not permanent and there is a concern that they could be withdrawn at any time,” she says.
She also questions the minister’s interpretation of research carried out by renowned US narcolepsy expert Dr Emmanuel Mignot.
Referring to a paper by Dr Mignot, which was published online in October 2012, Mr Reilly said that in the majority of narcolepsy cases, appropriate medication and lifestyle modifications could see functioning restored to about 80pc of normal.
According to Dr Mignot, a return to close to normal functioning was possible in about 80pc of cases through a combination of lifestyle changes and pharmaceutical treatment tailored to each individual.
His study advised that many patients with narcolepsy benefited best from combined drug therapy and behavioural modifications – scheduled napping one to three times a day, for example, while certain drug treatments had found to be of benefit to patients.
However, Ms Lawless points out, the treatments alluded to by the minister when quoting from Dr Mignot’s research are actually not deemed suitable for children
“The issues we have with the minister’s interpretation is that the therapeutic treatments that are referred to by Mignot are not licensed/recommended for use by children,” she says.
Referring to another piece of research published in December 2012 by experts at Stanford Medical Centre, with which Dr Mignot was also very closely associated, Dr Reilly said it indicated that narcolepsy was an autoimmune disorder, and that it was now possible to explore new therapies which may have more beneficial effects.
However, Ms Lawless said SOUND believed that the fruits of the research referred to by the minister were “so far in the future” that the children would be grown up by the time such therapies were available.
As a result, she believed they would be disadvantaged both educationally and career-wise.
“As our children go through education, they face huge difficulty maintaining focus and concentration which in turn will impact on exam results.
“We fear they will be discriminated against in job applications and employment due to their requirement to take naps and a propensity to lose focus/attention.
“They will likely be limited in operation of machinery including driving a car which curtails independence in itself, let alone ruling out many types of employment.”
Lawless also pointed out that although the research indicated that the majority could reach up to 80pc of normal function, that still left a sizeable number who would not reach that level of functioning.
“Furthermore,” she asks, “should we be happy about our children functioning at 80pc of normal capacity?”
GlaxoSmithKline, the makers of Pandemrix said: “Patient safety is our number one priority and we are actively conducting research on the observed association between Pandemrix and narcolepsy and on the interaction this vaccine might have had with other risk factors in affected individuals.
“Whilst people vaccinated with Pandemrix have been shown in several published studies to be more likely to develop narcolepsy than those who were not, further research is needed to confirm what role Pandemrix may have played in the development of narcolepsy among those affected.
“Narcolepsy is a complex disease and has a number of different potential contributory factors.
“The causes of narcolepsy are not yet fully understood but it is generally considered to be associated with genetic and environmental factors, including infections.
“It is crucial that we learn more about how narcolepsy is triggered.
“We remain committed to carrying out additional research into the potential role of Pandemrix in the development of narcolepsy.
“We are also supporting ongoing work from other experts and organisations investigating reported cases of the condition.”
(Reporting by Kate Kelland; Editing by Will Waterman)