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Insight: Evidence grows for narcolepsy linkto GSK swine flu shot

By Kate Kelland, Health and Science CorrespondentSTOCKHOLM | Tue Jan 22, 2013 7:26am EST

(Reuters) - Emelie Olsson is plagued byhallucinations and nightmares. When she wakes up,she's often paralyzed, unable to breathe properly orcall for help. During the day she can barely stayawake, and often misses school or having fun withfriends. She is only 14, but at times she haswondered if her life is worth living.Emelie is one of around 800 children in Sweden and elsewhere in Europewho developed narcolepsy, an incurable sleep disorder, after beingimmunized with the Pandemrix H1N1 swine flu vaccine made by Britishdrugmaker GlaxoSmithKline in 2009.

Finland, Norway, Ireland and France have seen spikes in narcolepsycases, too, and people familiar with the results of a soon-to-be-publishedstudy in Britain have told Reuters it will show a similar pattern in childrenthere.

Their fate, coping with an illness that all but destroys normal life, isdeveloping into what the health official who coordinated Sweden'svaccination campaign calls a "medical tragedy" that will demand risingscientific and medical attention.

Europe's drugs regulator has ruled Pandemrix should no longer be used inpeople aged under 20. The chief medical officer at GSK's vaccinesdivision, Norman Begg, says his firm views the issue extremely seriouslyand is "absolutely committed to getting to the bottom of this", but addsthere is not yet enough data or evidence to suggest a causal link.

Others - including Emmanuel Mignot, one of the world's leading experts onnarcolepsy, who is being funded by GSK to investigate further - agreemore research is needed but say the evidence is already clearly pointingin one direction.

"There's no doubt in my mind whatsoever that Pandemrix increased the

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Sweden andFinlandoccurrence of narcolepsy onset in children in some countries - and

probably in most countries," says Mignot, a specialist in the sleep disorderat 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 theUnited States because drug regulators there are wary of adjuvanted vaccines.

GSK says 795 people across Europe have reported developing narcolepsy since the vaccine'suse began in 2009.

Questions about how the narcolepsy cases are linked to Pandemrix, what the triggers andbiological mechanisms might have been, and whether there might be a genetic susceptibility arecurrently 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 Britishdoctor Andrew Wakefield who sparked a decades-long backlash against the measles, mumps andrubella (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 roguedoctor.

Independent teams of scientists have published peer-reviewed studies from Sweden, Finland andIreland showing the risk of developing narcolepsy after the 2009-2010 immunization campaign wasbetween seven and 13 times higher for children who had Pandemrix than for their unvaccinatedpeers.

"We really do want to get to the bottom of this. It's not in anyone's interests if there is a safetyissue that needs to be addressed," said GSK's Begg.

LIFE CHANGED

Emelie's parents, Charles and Marie Olsson, say she was a top student who loved playing thepiano, taking tennis lessons, creating art and having fun with friends. But her life started to changein early 2010, a few months after she had Pandemrix. In the spring of 2010, they noticed she wasoften 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 somethingserious 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 suddenand dramatic loss of muscle strength.

In Emelie's case, having fun is the emotional trigger. "I can't laugh or joke about with my friendsany more, because when I do I get cataplexies and collapse," she said in an interview at her homein the Swedish capital.

Narcolepsy is estimated to affect between 200 and 500 people per million and is a lifelongcondition. It has no known cure and scientists don't really know what causes it. But they do knowpatients have a deficit of a brain neurotransmitter called orexin, also known as hypocretin, whichregulates wakefulness.

Research has found that some people are born with a variant in a gene known as HLA that meansthey have low hypocretin, making them more susceptible to narcolepsy. Around 25 percent ofEuropeans are thought to have this genetic vulnerability.

When results of Emelie's hypocretin test came back in November last year, it showed she had 15percent 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 manyother young teens: "In the beginning I didn't really want to live any more, but now I have learned tohandle things better," she said.

TRIGGERS?

Scientists investigating these cases are looking in detail at Pandemrix's adjuvant, called AS03, forclues.

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 wasthe vaccine plus the genetic disposition alone or a third factor as well - like another infection - wesimply 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 someexperts 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 researchahead.

WAS IT WORTH IT?

In his glass-topped office building overlooking the Maria Magdalena church in Stockholm, GoranStiernstedt, a doctor turned public health official, has spent many difficult hours going over whathappened in his country during the swine flu pandemic, wondering if things should have beendifferent.

"The big question is was it worth it? And retrospectively I have to say it was not," he told Reuters inan interview.

Being a wealthy country, Sweden was at the front of the queue for pandemic vaccines. It gotPandemrix from GSK almost as soon as it was available, and a nationwide campaign got uptake ofthe 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 andRegions, 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 60people from swine flu death. Yet since the pandemic ended, more than 200 cases of narcolepsyhave 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 worldis facing a pandemic with the potential to wipe out millions than they do when it has emergedrelatively 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, andthe 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," hetold Reuters. "If we spent longer developing and testing the vaccine on very large numbers ofpeople and waited to see whether any of them developed narcolepsy, much of the populationmight 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. InPandemrix'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, includingchildren, 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'sthreat 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 wewouldn't need to worry about this ever again," he said. "But that's a long way off."

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With scientists facing years of investigation and research, Emelie just wants to make the best ofher life.

She reluctantly accepts that to do so, she needs a cocktail of drugs to try to control the narcolepsysymptoms. The stimulant Ritalin and the sleeping pill Sobril are prescribed for Emelie's daytimesleepiness 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 thiscondition I didn't take any pills, and now I have to take lots - maybe for the rest of my life. It's notgood 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)

(Reporting by Kate Kelland; Editing by Will Waterman)

We welcome comments that advance the story through relevant opinion, anecdotes, links and data. If you see a comment thatyou believe is irrelevant or inappropriate, you can flag it to our editors by using the report abuse links. Views expressed in thecomments do not represent those of Reuters. For more information on our comment policy, seehttp://blogs.reuters.com/fulldisclosure/2010/09/27/toward-a-more-thoughtful-conversation-on-stories/

Comments (18)

OrSpeeder wrote:

https://www.youtube.com/watch?v=tqgEMxmadtkJan 22, 2013 6:44am EST -- Report as abuse

americanguy wrote:

I wonder how many people will actually get past the headline and see this does not affect the US, and theyare still not sure what caused this?About 40,000 people die in the US each year from the flu, 100 or so are children.I had the flu about 5 years ago because I did not get the shots, I was sick as a dog. I will take my chanceswith the flu shots now.Jan 22, 2013 7:28am EST -- Report as abuse

THeRmoNukE wrote:

It’s a total joke. The other day the cleared pregnant women to take the flu shot. They think you’re an idiot!Jan 22, 2013 9:19am EST -- Report as abuse

This discussion is now closed. We welcome comments on our articles for alimited period after their publication.

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Insight: Evidence grows for narcolepsy linkto GSK swine flu shotComments (18)

OrSpeeder wrote:

https://www.youtube.com/watch?v=tqgEMxmadtkJan 22, 2013 6:44am EST -- Report as abuse

americanguy wrote:

I wonder how many people will actually get past the headline and see this does not affect the US, andthey are still not sure what caused this?About 40,000 people die in the US each year from the flu, 100 or so are children.I had the flu about 5 years ago because I did not get the shots, I was sick as a dog. I will take mychances with the flu shots now.Jan 22, 2013 7:28am EST -- Report as abuse

THeRmoNukE wrote:

It’s a total joke. The other day the cleared pregnant women to take the flu shot. They think you’re an idiot!Jan 22, 2013 9:19am EST -- Report as abuse

Overcast451 wrote:

Wow, what a surprise….

I’ll keep with avoiding all but the most crucial vaccinations as I have been for years.

And..

“I wonder how many people will actually get past the headline and see this does not affect the US, andthey are still not sure what caused this?”

For now, in this instance and from what has been told to the public – doesn’t mean what the US uses issafe. Nothing wrong with avoiding medications you DON’T ACTUALLY NEED.

I haven’t have the flu or a flu shot in 10 years.

This is why so many strains are ‘resistant’ now and so many people have weak immune systems.Jan 22, 2013 1:09pm EST -- Report as abuse

btreusdell wrote:

This article is irresponsible and premature. It lists sources who are already sure of an outcome before thestudy is released and providing a victim, as terrible as this is for her, who’s disease may not have evenbeen the result of what they purport it is. I think it’s dangerous fear-mongering. What we need is patience.As with all scientific investigation, it takes thorough, reproducible, peer reviewed study to determineactual, measurable effects. The only thing this article indicates is a correlation between the incident ofnarcolepsy and the flu vaccine and not, as they were careful to admit amidst the tear jerking, a causalone. Any number of factors could be involved in a incidence rate of 1%, meaning less than a 1% increaseover normal.

Be cautious. Be careful in how the data is interpreted. Be skeptical of claims made by people who havean opinion formed before the research is out, whether they have degrees or not. And don’t give the JennyMcCarthys out there more fodder.Jan 22, 2013 2:32pm EST -- Report as abuse

ucsddeej wrote:

Um, vaccines have nothing to do with why so many “strains are resistant” – completely different topic.Also, vaccines make your immune system stronger. People have weak immune systems because ofgenetics, helicopter parents that won’t allow their kids to play in the dirt or be touched by people without ahealthy dose of Purell, and/or toxins and chemicals in their local communities.

Vaccines have, and will continue to, save many more lives than any of these side-effects. Constant fearmongering and ignorance over vaccines have done nothing but start to erode our herd immunity – even tothe point of no longer conferring protection in those that need it most.

I agree with avoiding medications you don’t need, but saying that the risk/benefit for a flu vaccine in theelderly or pregnant population doesn’t swing towards using vaccines is just silly. Like americanguy wrote,the flu is a devastating illness, especially in high-risk populations. And the risk/benefit for the populationfor Hepatitis, MMR, Diptheria, Tetanus, pertussis, meningococcal (especially in dorm rooms) is so fartowards benefit it isn’t even funny. I hope for everyone’s sake that you define these as “crucial”.

That being said – narcolepsy is an awful condition and I hope anything we learn from this can be used tolimit these side effects in the future. Keep in mind too that correlation does not equal causation, and thejury is still out on this – a recent French study did not find any safety signals from 4.1 million doses of

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Pandemrix – including no reports of narcolepsy.Jan 22, 2013 3:51pm EST -- Report as abuse

Charcus wrote:

Obviously you are not up to date with your vaccine current events. You make mention to Dr. Wakefieldand his fraulent claims about the link between vaccines and autism. However, you neglected to mentionthat the United States Federal Vaccine Court just awarded two multi-million dollar settlements statedstating that there is a direct correlation between vaccines and a wide spectrum of learning disabilties. Dr.Wakefield is also now in a lawsuit to have his studies and papers on the matter reinstated. Perhapssomeday you will stop being a shill for the big pharma industry and do some actual reporting. I had highhopes for this article but you sold out.Jan 22, 2013 5:18pm EST -- Report as abuse

gregbrew56 wrote:

Seriously Carcus? Try doing some research on other than anti-vax sites. Check out Science BasedMedicine dot org (no spaces). There is an article entitled “An Anti-Vaccine Tale of Two Lawsuits”. It’shighly illuminating, and clearly shows that Wakefield is STILL considered a fraud and a shill for the plaintiffin an anti-vaccine lawsuit that prompted his “study” linking autism to vaccines. He continues to bediscredited, and his research considered totally bogus.

Stop trying to find a link that doesn’t exist.

Jenny McCarthy is a celebrity, not a scientist.Jan 22, 2013 7:23pm EST -- Report as abuse

OregonCharlie wrote:

Post hoc ergo propter hoc? How strong is the cause-effect? Give us some probability numbers. It will bethe etiology, strength, scope and amplitude of the phenomena that determines the significance of thethreat. We need to be very careful when interpreting & reporting this kind of research to provide thecontext necessary for accurate weighting of the information.Jan 22, 2013 11:27pm EST -- Report as abuse

gord5467 wrote:

“Canadian Forces links severe adverse reaction to H1N1 flu vaccine, arranges access to a Alberta HealthServices neurologist within 1 week and paid for multiple tests at private clinics ”

In 2009 I received the H1N1 shot (AREPANRIX by GSK GlaxoSmithKline) and had a severe adversereaction to the vaccine. The CF advised “I confirm that you did receive the H1N1 vaccine on 18 Nov 2009and as a results suffered an adverse reaction comprised of multiple complex symptoms (neurological,cardiac, respiratory, and gastrointestinal)” which include: dizziness, vertigo, irregular heart rhythms,shortness of breath, muscle weakness and pain, and numbness in hands and feet. The Department ofNational Defence (DND) paid for immediate access to private clinics such as Medical Imaging Consultantsto expedite testing which included Chest X rays (requested 8 Dec 2009, performed 9 Dec 2009), Fluoroscan (performed 26 Jan 2010), Chest Xray (performed 27 Jan 2010), MRI (requested 3 Mar 2010,performed 5 Mar 2010), a referral to a Neurologist at the University of Alberta Hospital (requested 16 Mar2010, performed 22 Mar 2010), Spinal Tap (requested 16 Mar 2010, performed 13 Apr 2010). My physicalfitness changed from marathon fit to that of a 70 year old in a matter of days. In 2012 the Canadian Forcesadvised “it is our opinion that your adverse reaction to the H1N1 vaccine, resulting in a syndrome ofcomplex symptoms, is service related”. It’s unfortunate the military forced me to release from the CF in2011 and suffer three years of severe symptoms before they admitted the cause was the vaccine.Jan 23, 2013 12:25am EST -- Report as abuse

Kate888 wrote:

If Kate Kelland reads this comment, perhaps you could share this information with those she interviewedwho were suffering narcolepsy.I am a licensed, practicing acupuncturist. Somnolence can be treated by reducing the KD 6 pointsbilaterally while also reinforcing bilaterally the BL 62 points.Some add to this treatment bilateral BL 1.Perhaps this “extraordinary meridian treatment” would be useful with narcolepsy.These are some other acupuncture points used for somnolence:Du 20, SJ 10, LI 2 or 3, ST 45, BL18….depending on the individual person.Please give this information to those suffering from narcolepsy and encourage them to contact a licensedprofessional trained in acupunture.Jan 23, 2013 1:01am EST -- Report as abuse

blahhh666 wrote:

And how many kids’ nervous systems were destroyed in not so outright ways?Jan 23, 2013 2:05pm EST -- Report as abuse

damanonthehill wrote:

If you do decide to shoot mystery juice from a mega coporation into you blood, get the thermasol freevariety.Jan 23, 2013 3:02pm EST -- Report as abuse

btreusdell wrote:

Charcus:

The Federal Vaccine Court pays out everytime someone sneezes. But aside from that, legal outcomeshave nothing to do with the science at issue. And to say something inflammatory: Kate888, how much didit cost for that acupuncture diploma and how long did it take to come in the mail? The scientificcommunity has recognized the effects of acupuncture and they’re no better than noise. You can’t use thatas an argument.Jan 23, 2013 3:23pm EST -- Report as abuse

NoodlesNR wrote:

These aren’t even tested on humans. Thanks, I’ll let everyone else be guinea pigs before I’ll consider it.And the people who die from the flu– it’s not even the full story. It doesn’t add that often times they arepeople who have suppressed immune systems, or ignorant parents who didn’t get proper treatment etc.And most of all, you don’t know that they DID get flu shots and died anyways, since it doesn’t cover allvarieties.Jan 23, 2013 4:46pm EST -- Report as abuse

Caitin wrote:

I received the Swine Flu jab and 3 months later I started having the symptons of Narcolepsy. That was 3years ago. Now I cannot work, drive, go out on my own, and do countless other normal activities becauseof Narcolepsy.There is no doubt in my mind it was the jab that caused it.Jan 23, 2013 9:20pm EST -- Report as abuse

tkharris wrote:

Interesting piece, but the author simply states as fact that the risk-benefit balance is unacceptable. Thatis not exactly reporting, it’s an opinion, and even were all the facts known, it would still be an opinion, anddoesn’t belong in a health news article.

Even if it were a known fact that this vaccine increases your chance of getting narcolepsy by a factor of 10while only reducing your risk of death from the flu by a half, I’m pretty sure that I would find thatacceptable. Narcolepsy is a terrible condition to have, but the symptoms are generally (but not always)well managed with the proper drugs. Maybe there will even be a cure for it some day. No cure for you ispossible if you’ve died from the flu!

I also wish that the article was a little more clear about the possible risks and why they are related to thevaccine. There’s nothing in there about how the peculiar immune responses in narcoleptics is implicatedin the narcolepsy syndrome (which can be triggered by a vaccine or by the infection itself). In other words,there is evidence that someone who gets narcolepsy from a vaccine is likely to get it anyway from somefuture infection.Jan 24, 2013 1:53pm EST -- Report as abuse

Narvik wrote:

Another Example of “A Rush to Profit” without regard of its human consequences!Excerpt: “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 [lab-generated] pandemic using another flustrain. In Pandemrix’s case, the substitute was H5N1 bird flu.”In case it hasn’t been noticed, the days of “Self-Regulating” and “Self-Policing” on the Assumption thatSafety Regulations and Ethical Behavior will be adhered to and maintained by any individual or Company,have been long gone! Gone, because it has long been replaced by GREED! When it comes to a choicebetween Ethical Behavior and “Profits”, “Profits” will win every time!Jan 26, 2013 12:37pm EST -- Report as abuse

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