Editorial Note: At the heart of RxISK is the idea that if something goes wrong for you on some medication you are the person best placed to know if there is an issue. But again and again when people raise a problem they find they are invalidated – nonsense, rubbish, its your illness or whatever.
If it is pointed out medicine had the same response fifty years ago to mothers whose infants were unwell – she was seen as neurotic – but we’ve learned now to run with the mother’s instinct, and a question is asked – why is an adverse event so different? – the response is usually well if this was case you’d have to believe all those people who claim they have been injured by a vaccine and we’d have pandaemonium.
In the case below, which involves the Flu Jab Pandemrix, the question is how do we go about establishing if this is a case of vaccine induced injury or not?
Before the Jab
I had all the normal childhood illnesses and vaccinations. I had rubella and BGC as a teen, and a few tetanus jabs, all without adverse effect.
I later had two pregnancies to term, all wisdom teeth removed, an operation to remove a bursa on my hip following a fall that hurt my back and made me walk wonky, all without problems.
Before I was given Pandemrix I was working for the Department of Work and Pensions and running a small online business. Busy life, busy mum but this was just “normal”. I was good. I was twice call handler of the year for the whole South East, constantly getting vouchers for going above and beyond, getting all the great and the good sitting to listen in with me on visits.
Jab
After I got the jab I immediately became ill with a severe flu like illness. I had two weeks off work. The time afterwards has become a blur as to diagnoses as no one knew what was wrong.
I was so tired. Coming in from work at two, I would fall asleep till teatime. After tea and the kids had gone to bed I’d nod off on the settee. All I seemed to do was sleep. I worked term times and I remember coming back to work after the Summer holidays and my boss asking the usual did I have a nice holiday and me replying that all I seemed to do was sleep. I used to go to the loo if I felt myself falling asleep. Endless walks to the photocopier. I reduced my hours, went home early. Work became a disaster.
Everything ached. After much coming and going to my GP I was referred to rheumatology. They said I had fibromyalgia. Maybe I do but this didn’t help or solve anything.
I took Prozac 20 mg because for 3 or 4 days a month I turned into a very different person fuelled by PMT. It was like switch being flicked. I would go mental for a few days and flick back to me again. I used to write letters to people and organisations if something offended me. I went to the Docs after I chased someone in my car who I felt had cut me up and sat revving outside their house like something from Duel.
As I am the type of person who never puts her head above the parapet I knew I needed to resolve this and the Prozac did help.
Deeper and Down
Then I started hallucinating sounds, specifically our buzzer. I would get up in a panic usually around four in the morning to answer it. I would try to get the kids up thinking we had slept in.
I was becoming forgetful, not recalling conversations or events. If I fell asleep on the sofa of a night watching a programme I would wake not knowing I had fallen asleep with my brain filling in detail that didn’t exist. I dropped things a lot. I could be seen staring off into space. I flooded the flat downstairs twice leaving the kitchen tap running. I had a small kitchen fire after turning the hob onto an electric chip pan I had left there to cool. There were multiple similar leaving the cooker on events where I just damaged things without setting fire to anything. Thank goodness for smoke alarms.
At night my dreams were becoming very vocal. I would often talk for up to an hour. My partner still talks about my lecture on a hydro energy plant where after about 40 minutes of my guided tour I said that “and on the second floor there will be shops”.
I seemed to be going to the GP every month. Apparently, I was depressed now. I didn’t feel depressed but I had no knowledge of mental health and assumed he knew better. More Prozac and now amitriptyline on top.
What was making me depressed was that I had no control of all these things happening to me. I thought for a time I was getting early onset dementia or something.
I recall one such GP visit where I had gone in with my usual I am tired, everything hurts, I keep falling asleep and I was given more Prozac. I was due to drive to Birmingham and I was worried about this. I told him I was falling asleep driving, hoping he would tell me not to drive or take note or do something, anything because I was panicking inside about what was happening to me. I got platitudes and was shown the door.
A few months later I was signed off work – “depression”. All I did was sleep.
Going to my GP was largely pointless but I did it anyway because I knew there was something wrong with me. I didn’t know what, and he seemed to see a woman in her forties, Prozac, bang, out the door.
Lightbulb
My GP was off and I saw a lovely young doctor who listened and almost her first question was about my sleep. Did I snore? Sleepwalk? She referred me to a Sleep Studies unit.
It was not a quick process, the appointments were slow to come and the first two sleep studies were “inconclusive”. I later found out this meant they had not recorded enough sleep time. On the third one, they came in the morning and told me that I had not slept. I said no, you are wrong, I slept great. They were puzzled and asked – so you thought you slept? I stayed all day and was put in a room for 15 minutes and watched still wired up etc. I fell asleep within minutes each time.
So, about a year after being referred I was diagnosed.
- Sleep Apnea
- Narcolepsy
- Periodic limb movement disorder
- Night terrors
- Restless legs
Meanwhile, I had lost my job. My daughter told Andy, my partner, that I was hitting myself in the car and had all the windows open to stop falling asleep taking her to school and still I kept hitting curbs. So I had to stop driving.
Life?
Having the Pandermix flu jab changed everything in my life. I don’t have a life now. I have an existence which I hate. I try not to dwell on it because hey, I’m not dead but it is hard. I think what makes it worse for me is that the jab was given to me at work. I worked for the DWP. I have done various freedom of information requests but apparently the jab never happened and none of my records exist anymore.
So here I am. Hitting 50 next year, trying to work self-employed. Having the indignity of applying for support payments to the agency whose reports to the DWP saying I was unfit for work and unlikely to ever be so got me fired. But still they make me go to interviews and then write to tell me how capable I am.
I can’t be left alone. The narcolepsy is bad enough but the sleep apnea on top means that if I fall asleep, I could choke and die because I should wear a Bpap mask when I sleep. So I am babysat if my partner goes out.
I have just got the brace off my leg from when I fell down the stairs in August in my sleep when I went to answer the non-existent doorbell.
I sleep on the sofa a couple of nights a week to give Andy a break from my talking and general night mentals. I hate going to sleep knowing I am going to disturb him. Aside from the talking, and skipping, running, and fighting, the night terrors are bad. It is as though I am in absolute mortal terror . I can’t talk. No words will come out but I get up my courage to give one massive scream or shout. He is 11 years older than me and I am convinced I will give him a heart attack. One time, my dog wet herself and hid under the bed.
My night-times are worse if I overheat so have a fan right next to me and windows open.
I won’t go out in case I fall asleep as often my sleep talking quickly becomes sleep tourettes with very loud, very bad language. If I get too animated my speech slurs. If I am fighting sleep my speech slurs and my neck and face muscles go into cataplexy.
One of the most painful things this condition has caused me was that it meant not going to see my once timid daughter, who got a scholarship to a really top school giving her speech as head girl on leavers day. How could I go and risk being an embarrassment?
Treatment
I take Ropinerole/Requip for the restless legs. It has been an absolute godsend. Took a while to get used to but it has genuinely been a lifesaver.
I take Modanafil but over time this has become less good. Other stimulants haven’t been any better. Modanafil caused my BP to soar – up to 230.
I have been offered Xyrem but I don’t want it. As far as I understand, once you are on that there is no where else to go. Like a drug of last resort.
I don’t know if it is harder to treat me because I am older than people with younger onset Narcolepsy. No one really tells me that. From my own perspective it is worse, because I know what I once was and what I have become. I imagine it is like going blind after having sight. Cruel.
Vaccine Caused?
So imagine you are back in 2009 when Pandemrix was being given to prevent Swine Flu. How do you respond to this woman if she raises a link between her Narcolepsy and her Flu Shot?
The authoritative response was – there is no link. Does all Hell (Pandaemonium) break loose if we don’t believe the authorities? What kind of evidence, if any, might be used to stop people from closing down a sensible debate about these questions?
A new narcolepsy epidemic
In 2010 there was a startling increase in narcolepsy across the UK and northern Europe. With new cases developing on a weekly basis, some doctors described it as an epidemic.
Why this matters
We believe that the causal link between the Pandemrix vaccine and a rise in narcolepsy cases has been established, and that our society has an obligation to look after individuals who develop narcolepsy as a result.
https://www.narcolepsy.org.uk/resources/pandemrix-narcolepsy
Brain-Damaged UK Victims of Swine Flu Vaccine to Get £60 Million Compensation
http://www.ibtimes.co.uk/brain-damaged-uk-victims-swine-flu-vaccine-get-60-million-compensation-1438572
Reports of narcolepsy in Europe following vaccination with Pandemrix™
GSK initially became aware of possible cases of narcolepsy following vaccination with the adjuvanted H1N1 pandemic vaccine Pandemrix through adverse event reports received by the Swedish Medical Products Agency, and subsequently via media reports in Finland
https://www.gsk.com/en-gb/media/press-releases/reports-of-narcolepsy-in-europe-following-vaccination-with-pandemrix/
GlaxoSmithKline European regulatory update on Pandemrix™
https://admin-awsproduction.gsk.com/en-gb/media/press-releases/glaxosmithkline-european-regulatory-update-on-pandemrix/
https://hansard.parliament.uk/Commons/2017-03-08/debates/438E7AE2-6025-4772-85BE-76920BDF8BE5/PandemrixVaccineCompensation
By way of background, the Pandemrix vaccine was developed by GlaxoSmithKline and given to 6 million people during the global H1N1—swine flu—pandemic in 2009 and 2010. Owing to the nature of that pandemic, the European Commission, on the advice of the European Medicines Agency, fast-tracked the vaccine’s licensing. The UK Government then undertook a vaccination programme, based on advice from the Joint Committee on Vaccination and Immunisation. In short, Pandemrix was licensed for use in the EU, including the UK, without the usual clinical trials having been completed.
Although I acknowledge the difficult balancing act involved in weighing the risk of a pandemic against the risk of fast-tracking a vaccine’s licensing, that does not excuse the fact that some patients were not made aware of the facts, nor does it excuse the Government from subsequently attempting to avoid responsibility for the damage caused. Making the vaccine available at the time of the pandemic clearly came with a degree of risk. GSK was given an indemnity from any liability by the UK Government. My constituent has made it clear to me that she was not informed that the vaccine had not been fully tested or that GSK had obtained an indemnity.
Prior to September 2013, the Government said there was insufficient evidence to establish a causal link between the Pandemrix vaccination and the development of narcolepsy.
To give some context to the UK Government’s position, Sweden, Finland, Norway, Iceland and France have already compensated those who developed narcolepsy as a result of the Pandemrix vaccine.
First, by virtue of GlaxoSmithKline requiring an indemnity, there was recognition that the vaccine carried a risk. Reliable studies now link the vaccine to narcolepsy.
The authoritative response here was – there is no link. Does all Hell (Pandaemonium) break loose if we don’t believe the authorities? What kind of evidence, if any, might be used to stop people from closing down a sensible debate about these questions?
It seems there is almost no story in which we are not involved in some way or another.
My daughter called me one day from Canada where she lives and dropped in, mum, I’ve got swine flu. I’ve had to pay to go to a doctor. I have been pretty poorly but I’m alright now after he told me to rest, sleep and see it out..
Annie, some more info re GSK, Pandemrix and conflicts of interest from a news article titled “WHO vaccine expert had conflict of interest, Danish newspaper claims”, published in The BMJ in 2010, a quote:
QUOTE:
Controversy has arisen at the World Health Organization after allegations that some WHO experts, including a leading vaccine adviser, have financial ties to the drug industry.
Documents acquired through the Danish Freedom of Information Act by the Danish daily newspaper Information show that Juhani Eskola, a Finnish vaccines adviser on the WHO board, has received £5.6m (€6.2m; $9m) for his research centre, the Finnish National Institute for Health and Welfare. The money, from GlaxoSmithKline for research on vaccines during 2009, is the institute’s main source of income.
Professor Eskola is the deputy director general of the institute and a member of WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), which advises member states on which vaccines to use and how much of these they should purchase.
GlaxoSmithKline produces the H1N1 vaccine Pandemrix, which the Finnish government stockpiled after recommendations from Professor Eskola’s institute and WHO.
Information recently alleged that several members of WHO’s expert group had ties with the drug industry. It also claimed that, although some of these alleged conflicts of interest had been made public, Professor
Eskola’s links had been withheld…
END OF QUOTE
The new method of dealing with mistrust in the vaccine programme is to blame it on Putin and the Russians: apparently we all work for them.
http://www.mirror.co.uk/news/uk-news/russian-cyber-units-spreading-false-11592627
As Jim Carrey remarked before they shut him up “the problem is the problem”. They have a pipeline of products on the way and nothing must be allowed to disrupt it.
Fake news science pretty scary.
Allen Frances @AllenFrancesMD Nov 27
Allen Frances Retweeted RealTruthAboutHealth
Weirdest panel I’ve ever been on.
Director of “Vaxxed: From Cover-Up to Catastrophe” confidently presents #Wakefield conspiracy theory #Vaccination causes #Autism.
I try to defend reality/diagnostic caution, but audience strongly agrees with him
Fake news science pretty scary.
https://twitter.com/AllenFrancesMD/status/935128720213385219
https://twitter.com/RTAHealth/status/935074513318023168
The Truth About Vaccines | Experts Panel
https://www.youtube.com/watch?time_continue=5&v=yVLZZpDmF4U
“all these things lead to the same problem” ..
Weirdest Panel or ‘Weirdest’ Panel ..
The Flu Jab – Tom is a 71 year old man – he had the flu jab Monday of last week – he has it every year and seemed OK those years – Last Monday week he was given the Vitamin B12 injection the same morning he got the Flu Jab – by the time he got back to his house he could hardly move – he says he has had three injections – but he was calling the blood tests an injection also. By day 3 he was in the full heights of the ‘flu and was very disorientated – his muscles were sore, his joints and sweat was pouring out of him that he had to change his clothes several times over the next days.
He was confused as to what happened. He had bruising coming up on the back of the hand but I reminded him that that was from the B12 injection which he had last year as well. I asked him to go back to his doctor. He said there is no need to as he is to see him the following Monday to get the Pneumonia vaccine injection. I told him that I had never heard of the Pneumonia injection – he said that GP told him the Pneumonia injection is only once in a lifetime jab. Within 6 days of the flu/vitamin B12 he could not sleep. By the time he went to the doctor a week after receiving the Jabs he was still very ill. Thankfully he told the GP that he doesn’t think he could take another injection – the GP has put the Pneumonia injection off for a further two weeks. His blood tests show that his iron is low so he has been put on Galfer – one a day. When I read Dr Healy’s post on the Flu Jab, I asked Tom to read it – I wanted him to read about the anger bits and the mood changes. Thankfully he did read it. I noted that Tom who was always an antagonist – he would shout at politicians etc on television to the point he had to be asked to “calm down before you give yourself a heart attack” but his irritability was different this time. In 10 days I witnessed a different man – he was so frustrated, tired, shouting at the least little thing and just in bad mood. For the first time I saw a frightened anguished old man who did not understand what the hell was happening to him….
He goes back to his GP he trusts to get the Pneumonia Jab. I pray he doesn’t…
The Flu Jab, and the dilemma facing certain healthcare professionals.
At a recent appointment for treatment by my osteopath, who I have known for several years, who is very effective, and for whom I have great respect, the conversation turned to vaccines, as I had been thinking about getting my annual flu jab. I have been following the discussions on RxISK recently on vaccine safety, and was telling her this.
She told me that a colleague of hers in the same county, who had strong feelings about vaccine safety as she has done a lot of research on the subject, got into a similar conversation with a patient, and without trying to influence that person, merely expressed her own views, partly gained from a publication called WDDTY (What Doctors Don’t Tell You) she assumes. It could have been from reading RxISK of course, we don’t have this factual detail.
To her consternation, that osteopath received a menacing letter from the patient”s GP saying how dare she influence anyone not to have vaccinations, she is not a doctor, and vaccination is not part of her work. It has brewed up into a big row and disciplinary action being taken against her. She insists she would never advise a patient on the subject of vaccinations professionally, but on the other hand, she is known to feel passionate about vaccine harms, and was just drawn into conversation by the patient, and simply expressed her personal views. It seems that her own Union has not been very supportive, though again, we do not have factual detail on this,
But what is concerning is that doctors can become angry, and take to task others practising in the health field, for daring to express their views or directing interested patients to research, on vaccination, by writing them strong and menacing letters and putting their livelihoods at risk. The osteopath in question has been so shaken by this that she is thinking of giving up her work. One assumes that the patient had gone to see the GP on some matter but declined a vaccination of some sort, and said they were concerned about it having heard more information about it from their osteopath in discussion during treatment.
Does this mean that other health workers are now putting their jobs at risk if they dare to express views on the safety of vaccinations?
‘The antivaccination people are very active, and the media doesn’t want any trouble. It’s a sad story.’
Doctor wins 2017 John Maddox prize for countering HPV vaccine misinformation
Riko Muranaka awarded prize for efforts to explain jabs’s safety amid scare campaigns which have seen Japanese vaccination rate fall from over 70% to 1%
https://www.theguardian.com/science/2017/nov/30/doctor-wins-2017-john-maddox-prize-countering-hpv-vaccine-misinformation-riko-muranaka?CMP=Share_iOSApp_Other
Simon Wessely Retweeted
Sense about ScienceVerified account @senseaboutsci 13h13 hours ago
Congratulations Dr Riko Muranaka! Winner of the 2017 #MaddoxPrize!
http://www.sciencemag.org/news/2017/11/qa-japanese-physician-snares-prize-battling-antivaccine-campaigners
Sense about Science Retweeted
BBC Woman’s HourVerified account @BBCWomansHour 11h11 hours ago
Tomorrow at 10am, we’re joined by the winner of the #MaddoxPrize – a prize celebrating sound science of public interest in the face of difficulty and hostility
If @SaS and @WesselyS wanted an ‘explosive’ interview with @womans hour and @Maddox Prize winner – they didn’t get it .. the ‘sparkly socks’ interview went alright though ..
http://www.bbc.co.uk/programmes/b09gbnjl#play
Complete mystery surrounds what has happened to the Vaccine Damage Payment Act awards for narcolepsy injury from Pandemrix. The government was first of all forced to acknowledge such injuries happened because they were being picked up by agencies in Scandinavia, but the Department of Works and Pensions had created a Catch22 to avoid payment, by claiming that future needs were unpredictable – a preposterous claim with was thrown out in the Court of Appeal early this year. But apparently still no awards have been made. In fact it appears that no awards have been made under the act since 2010, and these had indeed be reduced to a trickle since the early 1980s.
http://www.ageofautism.com/2017/08/hit-and-run-vaccine-policy-of-the-british-government-revealed-damage-settlements-go-from-hundreds-to-zero-in-four-decades.html
Of course, if governments don’t have to acknowledge injury it somewhat reduces the incentive to avoid it in the first place, and there is no doubt the Pandemrix project was inherently reckless – which was acknowledged by the government providing legal indemnities to the manufacturer, GSK. Even this, however, is likely to prove a fairly notional risk as I am sure the victims and their families will be continue to be obstructed from bringing a prosecution.
Readers may btw be interested in my evidence to the House of Commons Digital, Culture, Media and Sport Committee inquiry into Fake News, which the committee have now published.
http://data.parliament.uk/writtenevidence/committeeevidence.svc/evidencedocument/digital-culture-media-and-sport-committee/fake-news/written/73097.pdf
A leading politician at the time offered me the view at the time of the swine flu scare that they could not be seen to do nothing, but I also recall a leading critic of the vaccine system – Marc Gerard – comment on French TV that in the Middle Ages they would probably kill some Jews if the wanted to do something, but it did not make any more sense.
Here’s how it goes for your average patient this year in the UK; the NHS is teetering on the brink of chaos this winter, due to chronic underfunding, lack of acute beds and all the rest. The flu jab has become a political football – because an outbreak of flu is likely to cause a ‘last straw’ scenario. So, Public Health England launches its biggest ever campaign to increase uptake of the vaccine (presumably using a PR firm, at some cost). This, despite the fact that it takes a PhD in pharmacology to work out which strains are covered by the 2017 vaccine and whether that includes the one that caused problems in Australia recently. It is, frankly, impossible to work out for yourself whether the jab will protect you – the only figures I tracked down were a general admission that, at best, it reduces your risk of flu by 60%. Which is fine, real flu is deeply unpleasant….but. I had the jab last year and, like everyone else I know who also had it, spent 10 days feeling unwell – and most of the winter suffering from various flu-like viruses. I may not have succumbed to the real McCoy but neither did I feel great.
The medical narrative goes like this:
It is your civic duty to have the jab, otherwise you will spread the virus and kill small babies and old people.
It is frankly impossible to feel unwell as a consequence of the jab; if you say that you have felt grotty before, that is because you are damn stupid and don’t understand the difference between an active virus and the inactivated vaccine. You are having a psychosomatic, imagined reaction.
If you persist in maintaining that last year you felt so ill, you are not prepared to have it again, you may get a grudging acknowledgment that some localised pain at the site of the injection is possible – and that, just possibly, your immune system reacting to the inactivated vaccine might make you feel a bit unwell for a few days. HOWEVER – that is very, very small beer compared to having flu, so……
This year, since the beginning of November, I have received
two letters from my surgery, inviting me to have the jab.
A friendly voicemail on my mobile from the practice nurse inviting me to have the jab.
A daily text message inviting me to have the jab.
The day I got two text messages, I blocked the surgery number. It felt like, and was, harassment. The very fine line between offering a patient a (possibly) preventative vaccine, in the absence of any informed discussion, and state enforcement of a treatment is getting gossamer thin. I suspect enforcement is closer than I like to think, as more and more people are becoming refuseniks. Patients are not as stupid as we are so frequently made to feel: it doesn’t seem to have occurred to anyone that the unintended consequence of pressuring people into being vaccinated is likely to be resistance – not to influenza but to having the jab at all.