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File photo from October 2009 Leon Farrell/Photocall Ireland

Government official defends indemnity for swine flue vaccine makers

A report published yesterday has confirmed the link between an increased risk of narcolepsy and the H1N1 vaccine Pandemrix.

THE CHIEF MEDICAL Officer at the Department of Health has defended the indemnity provided by the Government to pharmaceutical companies who manufactured and delivered the Pandemrix vaccination which has been linked to over 30 cases of narcolepsy in children.

Speaking on Primetime last night, Dr Tony Holohan said he was not concerned about the safety of the vaccination back two years ago, adding that it was the “right decision at the time”.

“It was critical that we got access to ‘good vaccines’ as quickly as possible,” Holohan said, recalling the swine flu pandemic of 2009. He noted that all other European states who bought the drug were required to sign the same deal.

“This was an unusual situation…in order to have access to this vaccine, we had to pay at the price demanded by the companies and to also accept the liability,” he explained.

There is no doubt that the vaccinating companies were in a strong negotiating position.

The question of compensation has arisen after a report published yesterday concluded that the increased risk for young people of developing narcolepsy was associated with Pandremix.

Similar results have been found in both Sweden and Norway.

Because of the indemnity provided to Glaxosmithkline, the makers of Pandemrix, any legal liabilities have been taken over by the Irish State. That means that any compensation bill will be footed by the taxpayer, and not the drug’s manufacturer.

Compensations

The Department of Health and the HSE, along with the Department of Education are currently working on a package of measures for the families affected by the condition.

This will include health and educational supports but it is still unclear what (if any) monetary compensation will be offered.

SOUND, a campaign group set up by those families, has said that the children should be compensated for the loss of the life they would have had if they had not been vaccinated.

“Our children…now have a life-altering, life-long condition,” said Mairead Lawless, parent of one of the sufferers. “We are not aware of what the overall package is as yet but Dr Holohan said he will revert to us in a short timeframe.”

Educational and health supports will be put in place but parents are frustrated by the slow progress being made.

Describing yesterday as a “bittersweet” day, Hilary Dowdall said that the report confirmed what the families had known for two years. She also expressed their regret that educational supports have taken this long to implement given some sufferers are sitting Leaving Cert and Junior Cert exams this year.

We are not happy with the speed at which they have taken. And we really want to talk about compensation.

Yesterday’s report said there was a 13-fold higher risk of narcolepsy in vaccinated people compared to unvaccinated individuals.

A total of 32 cases were reported, with 28 of these occurring in children and adolescents aged five to 19.

However, it added that it is “very unlikely that the vaccine alone would be sufficient to explain what has been observed”. International experts agree that a number of factors are likely to have contributed to an increased risk.

Symptoms in the 32 cases began to appear between two and 20 months after the vaccination was given.

Holohan has moved to assure the public that vaccinations are the most safe and most effective form of protection for one’s health.

Vaccination is very safe and it is important that the current vaccination programmes continue to protect children and adults against the serious consequences caused by these preventable diseases. People can continue to have a high level of confidence in our vaccination programmes.

Narcolepsy is a chronic sleep disorder which can cause sleep attacks at inappropriate times but sufferers can also be impacted by muscular weakness and dream-like hallucinations.

The use of Pandemrix has ceased in Ireland and all stocks are being returned by administering GPs.

Download the full report from the Department of Health website>

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29 Comments
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    Mute Susie Chester
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    Apr 20th 2012, 10:47 AM

    How awful ,for the victims of this vaccine. It is indeed a life changing and chronic condition . The parents must be distraught after taking the advice of the government and the HSE at the time ,to find that their lives and the lives of their children have changed .So sad ! I hope they do get some form of compensation and support for the children’s education and future prospects.

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    Mute Aranthos Faroth
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    Apr 20th 2012, 11:02 AM

    Shows the kind of panic going around about this virus, sure it was dangerous but was it more dangerous than a vaccine that noone had any idea what complications it had with it? I think not.

    The vaccine makers had their eyes on the prize – money, and really didn’t give a damn about the users.
    I think because of this fact alone, they should be held responsible alongside the govornments who signed a ‘get out of jail free’ clause of the makers.

    34
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    Mute Susie Chester
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    Apr 20th 2012, 11:40 AM

    http://www.youtube.com/watch?v=7kcaxd-qGeE
    Please watch this and share ,
    it is long but it is pertinent to your comment on ”The vaccine makers had their eyes on the prize – money” Thanks !

    9
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    Mute Dermot Mc Loughlin
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    Apr 20th 2012, 11:12 AM

    “That means that any compensation bill will be footed by the taxpayer,”

    Well why bother breaking the general rule here, so far we’ve bailed out banks, the euro, the catholic church so why should pharmaceutical companies be exempt from our generosity.

    30
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    Mute Bryan Rooney
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    Apr 20th 2012, 10:54 AM

    You would have thought that the powers that be would have been absolutely & without reservation 100% sure that the medicine they prescribed was trouble free. It’s shocking to say the least & simply not good enough.

    29
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    Mute Noddy Mooney
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    Apr 20th 2012, 12:47 PM

    it is shocking, but no medicine is 100% trouble free. Pharmaceutical companies are drug dealers to you know!

    19
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    Mute John Horan
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    Apr 20th 2012, 4:20 PM

    Just to give you some background on how clinical trials work. The process generally is split into preclinical, which are preformed on animals, clinical, which are further broken down into 4 phases, depending on the number of people involved and exactly what they are looking for. Phase 3 trials typically have about 300-3000 people being monitored, so side effects which only effect a very low number of people or take a very long time to present, may not be detected.

    After that comes phase 4 trials, which are available to anyone seeking treatment from their physician, and are to watch a drug’s long term effects. Unfortunately to catch these long term effects, you need a very large sample set and quite a bit of time. If we were to demand that every drug is 100% trouble free before being prescribed, then we could never do these types of long term studies and never determine if they are 100% trouble free.

    All drugs, vaccines or otherwise, are put through this same process. The only exceptions are when we are faced with possible pandemics, as we were with the flu in 2009. Then a decision needs to be made about whether to go with a vaccine that isn’t 100% tested (i.e. not given the time to really monitor for long term effects) or to risk a pandemic. Also because vaccines are preventative and not reactive, like other medicines, we need to make that decision well in advance. Obviously it would be great if we had a way to test medicine without having to be faced with these difficult decisions, unfortunately we don’t.

    5
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    Mute Michelle Byrne Keane
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    Apr 20th 2012, 12:25 PM

    So glad my kids didn’t get it, I knew it was too soon for a new vaccine for a new epidemic!! Glad I stuck to my way of thinking.

    20
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    Mute Bernadette Dunne
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    Apr 21st 2012, 9:14 AM

    Michelle Byrne Keane …. A very dear friend said to me (at the time of the our DEPT of Health announced that the vaccine for the swine flu was available) be careful this vaccine has come out very fast It normally takes years to produce a vaccine for anything and then it takes year to have it all passed by the World Health Authority.. This Vaccine was out within a few weeks and this Person just said THINK SERIOUSLY about going for it We Do Not know enough about it yet So No None of my family went for this vaccine and Now I am ever greatful to my friend for her words of wisdom
    Shame on the manufactorers of this and THey should be held responcible…. I wish the children and their Families all the very best in the future shocking news for you all

    4
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    Mute Stephen Maher
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    Apr 20th 2012, 11:23 AM

    . . . . . and there was me thinking Alex Jones was as nutty as a fruitcake when he was yelling and roaring about swine flu shots making people sick with all sorts of ailments.

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    Mute Sovereign Being
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    Apr 20th 2012, 3:05 PM

    Alex Jones is a loudmouth arsehole, but he was right about vaccines. He gives a lot of disinformation (mostly from a fundy point of view), but even the biggest liars tell the truth sometimes.

    9
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    Mute Vocal Outrage
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    Apr 20th 2012, 10:54 AM

    I know that statistically all vacinnes have side effects upon a proportion of the population. So my questions would be, how many vaccines were administered and in light of that are 32 cases, so far, considered high for a vaccination programme?

    19
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    Mute John Horan
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    Apr 20th 2012, 5:15 PM

    The Swedish and Finish medical boards estimate it is at least 3.6 cases per 100000 vaccinations. I don’t know how that compares against other vaccines.

    4
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    Mute James Doyle
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    Apr 20th 2012, 1:15 PM

    Thank god I refused the vaccine as well as my wife and children,when I heard they could have been traces of mercury in this vaccination that was a no from me

    15
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    Mute The Burning bush
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    Apr 20th 2012, 1:03 PM

    This vaccine was in such demand that there was simply not enough to go round, the full regulatory approval process for its distribution was incomplete. The urgency of the governments request for supplies was such that the pharmaceutical company insisted on and received full indemnity from our government in exchange for access to what was for good reason, a drug in short supply.

    The Irish government appear to have no less than a prize winning ability to completely screw things up for the people they represent. Everything they remotely have a hand in turns to shit.

    13
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    Mute Shanti Om
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    Apr 20th 2012, 2:32 PM

    Really? Nothing to do with the last swine flu epidemic in ’76 where loads of people got Guillan Barre and some people died?
    Because as far as I know they’ve enjoyed indemnity on every vaccine manufactured since..

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    Mute The Burning bush
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    Apr 20th 2012, 3:43 PM

    “It was critical that we got access to ‘good vaccines’ as quickly as possible,” Holohan said, recalling the swine flu pandemic of 2009. He noted that all other European states who bought the drug were required to sign the same deal.

    So in 1976 some people died due to a reaction to a vaccine manufactured by a pharmaceutical and as a consequence this set a legal precedent of some kind that served to extend a form of blanket indemnity that continues to exist today. OK……thats interesting.

    Perhaps when Glaxo requested indemnity from our government for Pandermrix they had in mind two scoops of the same flavoured ice cream instead of one, and the agreement by our government to grant that indemnity was the chocolate sauce or maybe it was the sprinkles.

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    Mute Shanti Om
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    Apr 20th 2012, 6:25 PM

    It’s an interesting one alright..
    On one hand we would like the pharmaceutical industry to continue making drugs in the hope that maybe they can cure illness, a utopian idea but one we strive for nonetheless.
    But side effects are common, and some are worse than others. If you are adversely affected you have good reason to expect compensation.

    Now, no big industry wishes to cover all that compensation, we know that, the bigger they are the more likely they are to try and share or avoid that responsibility. We have seen it so many times, like with the banks, the Vatican.. You get rich by making sure you don’t have to pay out, it’s sickening, but it is true.

    So, the indemnity refers to government vaccination programmes, the government is encouraging it – so they take responsibility. If your doctor prescribes the wrong thing they take the hit. It seems the only time you can sue a pharmaceutical company is when you can prove that they knowingly put an unsafe drug on the market, and that is much harder, it has happened though (see Avandia, Vioxx, Bextra).

    4
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    Mute The Burning bush
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    Apr 20th 2012, 8:41 PM

    It’s Precarious balancing act alright and as you point out it is an uphill challenge to prove liability. Just never appears to be enough information available to the consumer in such cases as these. My decision not to inoculate my child was based entirely on the fact that the government had given this indemnity and for me that was enough to ring an alarm bell or two.

    No class actions allowed in this jurisdiction either which certainly serves to protract the matter and as such also makes it a rather expensive exercise to take on an individual basis. Altogether a crappy set of scales on this side of the Atlantic where these matters are concerned. Still, the Irish CMO looks as though he has been put through the ringer, but thats hardly any compensation for those now with narcolepsy.

    A lousy lottery result for all concerned.

    4
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    Mute Shanti Om
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    Apr 20th 2012, 10:16 PM

    There’s barely enough information given to doctors! It’s a fact that industry funded data rarely suggests less than optimal results, and is next to impossible to recreate (meaning it was probably false to begin with). There’s data manipulation, ghostwriting, failure to disclose placebo ingredients, Ben Goldacre said there’s over 600,000 ways to rig a clinical trial – that’s more than a tad worrying..
    I mean, doctors are relying on this data to make informed decisions in prescriptions, if the data is fudged – what on earth are they supposed to do?

    2
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    Mute Sarah Curran
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    Apr 20th 2012, 1:34 PM

    Im horrified that i was pressured into giving my children this vaccine. i wasn’t in favour of it but got so many letters and phone calls asking me why i hadn’t got my children this vaccination that in the end i gave in. what a bad decision on my part! i didn’t get the vaccine myself and will never again be pressured and made to feel my choices regarding any vaccination is wrong. pharmaceutical companies are among the most powerful in the world and can certainly scare you into taking drugs that they say are best… my heart goes out to those children and their families.

    12
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    Mute Amy O Doherty
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    Apr 20th 2012, 12:42 PM

    i didnt let my children have this as it was so new no one could know the effects, they both had swine flu (diagnosed by doctor) and they were not that ill not a lot worse then a cold but then some people can catch it and die so you have to weigh up the risks with these things it can be hard to decide what’s best with so many unknowns poor kids their lives will be forever changed

    10
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    Mute Niall Carson
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    Apr 20th 2012, 2:15 PM

    For god sake I think the fact the vaccine companies wanted an indemnity should have been a warning sign to the government. The vaccine was banned in other european countries before it was sanctioned by the Irish medicines board. The cheif medical officer should now resign

    9
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    Mute Sean Armstrong
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    Apr 20th 2012, 2:17 PM

    What other European countries banned it?

    1
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    Mute Killian Fitzpatrick
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    Apr 20th 2012, 1:05 PM

    After researching this drug online, I decided to opt for the other version for my kids. Delighted I did it now but I can tell you for a fact that the HSE were fully aware of the potential side effects of Pandemrix but constantly pushed it as they had purchased huge amounts of it. The most pertinent question here is WHY did Glaxo insist on an indemnity clause before they would supply it? My brother in law was publicly told by a nurse to please keep quiet about his concerns regarding Pandemrix in front of other parents waiting to get the vaccine. Wonder why that was??????????
    Society’s concerns are not the government’s problem, the bottom line is, always!

    7
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    Mute Bridget Dolan-Sullivan
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    Jan 13th 2013, 7:17 PM

    My son got the vaccine through the school, full disclosure as to side effects was not given, they asked if you or your child ever had a reaction to eggs, formaldehyde,gentamycin, thiomersal?> Have you/your child ever had Guillian Barre Syndrome. Not for nothing – why do they switch from eggs to clinical words. If you never had any of these things before – how would you know if you had a reaction/ How many people go out there, with fancy names to test what they are allergic to. Why was pandemrix withdrawn on other markets and allowed here. We are undergoing investigations at our own costs, going without a lot, since my son had a reaction, and we went through the HSE and the person in temple street, said it was in our heads and that we needed to see a physcologist, we went to a sleep specialist, privately, – we don’t have insurance or a medical card, and the first night – the study had to be cut short as my son had severe obstructive apnea – That is not in the family, and it wasn’t present before. he still has shakes, shudders, aches, pains, tiredness. He clawed through 3 mattresses in his sleep, and doesn’t remember, a hole in the cement wall down the block – in his sleep. I have to get up every 2 hours to make sure he keeps the mask on – as a couple of times – he took it off and didn’t remember. I’ve put a video on youtube, . We have contacted everyone we can think of – and getting nowhere – the irish government don’t want to know. The Health Service don’t want to know. I have applied for DCA – to help fund costs – we got turned down, applying for everything to help with the costs – and getting nowhere. GSK, Irish Goverment don’t give a damn about the people and the kids they hurt.

    4
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    Mute Barry Lynch
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    Apr 20th 2012, 1:44 PM

    Does anyone remember when
    Live Avian Flu Virus Placed in Baxter Vaccine Materials was Sent to 18 Countries? I think it happened in 2009.

    http://www.naturalnews.com/025760.html

    If the vaccines had been administered the virus would have spread very quickly around the world and hundreds of millions of people would have died.

    Does anyone remember this story?

    4
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    Mute Mary Kelleher
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    Apr 20th 2012, 1:45 PM

    what about the pregnant mothers has anyone any idea how of if they or their children were affected as they were advised to take this flu jab i would appreciate so info if anyone has a link etc

    4
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    Mute Shanti Om
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    Apr 20th 2012, 3:04 PM

    It’s not weird that the government signed a deal offering the manufacturers indemnity.

    In 1976 there was, oddly enough, a Swine Flu outbreak. There was a mass innoculation programme, which caused an 11 fold increase in the incidence of Guillan Barre Syndrome, a paralysing nerve disorder. A few people died.

    As a result, the US President, Henry Ford, opted to grant vaccine manufacturers full indemnity. Presumably as they weren’t willing to take the hit again, and that would mean no new vaccines at all.

    Your doctor is the one who takes a duty of care oath. The pharmaceutical company doesn’t. They are an industry, they want to turn a profit and keep costs down, and they have a lot of power because we need their product. If they say they won’t provide unless they get the immunity they are used to, the government has no option that will satisfy the populace seeking it.

    3
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