Finland stops giving Swine Flu vaccine due to increased cases of Narcolepsy

[Skeptic Ginger]

I got the flu shot last winter, and since then I have been falling asleep every night. I just get so tired around 11 pm...

 

[Mirrorglass]

But you don't know that. Who do you think they reported the data to? Was it a coincidence and these doctors just happened to be the researchers interested in publishing a paper?

I probably wasn't clear; these doctors weren't the ones affiliated with the paper. The cases were recorded, of course, just like all medical information is, but some doctors did not notify the authorities responsible for looking for side-effects of the vaccination. This was most likely due to human error, but is technically misconduct. It is not related to the paper; I merely mentioned it because you asked me to explain what I believe was done wrong, and this is one of the things that were.

And yes, I do know that. I have read most of the writings about the subject in Finnish papers, and have spoken about this very matter with MDs I've no reason to doubt know what they're talking about.

No, the doctors who first saw these patients would very likely be unrelated to the research project. The doctors who saw the patients would have reported the incidents and that's how the researchers eventually obtained the data.

They recorded the incidents, of course, and that's how the researchers obtained the data. The problem is they didn't forward those records to all the relevant authorities.

With such an extremely rare potential side effect and a potentially deadly vaccine preventable disease, it is irresponsible to start ringing alarm bells on such a paucity of data.

Well, that's very little to do with what I'm talking about. It's certainly not irresponsible to notify the bodies monitoring vaccination side-effects of a twice-more-than-expected incidence of narcolepsy in vaccinated children.

Mind you, I'm not saying the researchers should have immediately notified the media.

I believe that is a misconstrued comment. There are rules about publishing material that has been previously published. But leaks and news reports are not the issue, copyright law is.

You are now accusing me of lying about the comment in a Finnish newspaper. There's not an awful lot I can do about that; as demonstrated earlier in this thread, the google translation of the comment is somewhat confusing. Unless you can get a Finnish-speaking person you trust to verify that my translation is accurate, there's nothing I can do to convince you.

I do have some other articles to support my view; on 26th August, Partinen was called to a hearing by the Ministry of Health, concerning possibly failing to inform relevant organs of the ministry of possible adverse side-effects of the vaccination and spreading misinformation.

Also, in a report linked earlier in the thread, it was noted that Partinen went from claiming a 99% certain connection to believing the whole connection was an unfortunate mistake during the same week.

Both articles are in Finnish, unfortunately.

I didn't read any such thing. I read that the news media would screw up the information if given snippets and the professional community would then not have the actual data to confirm or refute the news media nonsense.

Again, if you doubt the accuracy of my translation, there's not much I can do about it.

This should be examined as a separate issue. I need more data before knowing what this is about. All we have are rumors or one kind or another.

Yes, it is indeed a separate issue, but still concerns the trustworthiness of the research itself. Here is the article where neurologist Ismo Ilveskoski, credited as one of the authors of the paper, comments on it's general poor quality and states he was not in any way aware of the paper, despite his name appearing in it.

In conclusion, the evidence seems to suggest the entire paper is rather shady, and the connection may very well be nonexistent. However, assuming the cases of narcolepsy were real, which I've no reason to doubt, they were inadequately reported.

 

[Mirrorglass]

Well, the latest news is that the Ministry did not find Partinen guilty of any negligence. I'm still interested to see what comes of the paper, though.

 

[Skeptic Ginger]

Mirrorglass, if the system of pharmaceutical safety relied on some off chance a researcher was interested in a paper on a topic, it would be a pretty inconsistent system.

So you are mistaken on two counts. One, that authorities would be relying on this kind of reporting. But more importantly, what I already said, there is no imminent danger issue here. You are seriously overreacting. You don't go jumping the gun on this kind of data or research. You are talking about an extremely thin connection here and expecting these researchers to sound some alarm?

Similar things are found in studies all the time and no one would expect the researchers to be acting like they uncovered some potentially fatal danger that required immediate alarm bells be sounded. Science is just not that exact and this is a very inexact example.

I think you have a misconception here.

 

[Mirrorglass]

Mirrorglass, if the system of pharmaceutical safety relied on some off chance a researcher was interested in a paper on a topic, it would be a pretty inconsistent system.

So you are mistaken on two counts. One, that authorities would be relying on this kind of reporting. But more importantly, what I already said, there is no imminent danger issue here. You are seriously overreacting. You don't go jumping the gun on this kind of data or research. You are talking about an extremely thin connection here and expecting these researchers to sound some alarm?

Similar things are found in studies all the time and no one would expect the researchers to be acting like they uncovered some potentially fatal danger that required immediate alarm bells be sounded. Science is just not that exact and this is a very inexact example.

I think you have a misconception here.

You are misunderstanding my position. To once more attempt to clarify some of your misunderstanding; I am not jumping the gun. I am not saying the situation was dangerous. I am not saying the research should have been rushed, alarm bells sounded and media informed.

What I am saying is that while there are pathways through which the authorities learn of things like this, Partinen was part of those pathways, and there was some question of how adequately he did his job. He was also not the only one. Admittedly, the Ministry decided he wasn't guilty of negligence, but there definitely was a question of whether he was.

And I am saying it because you asked me what I considered to be wrong about the handling of this case. Not because I want a global panic, not because I believe there is some imminent danger issue, but because you asked about misconducts, and here is a minor misconduct.

Once more: I'm not talking about 'sounding immediate alarm bells', but reporting to the relevant authorities as per required by the Finnish law. There is a difference.

 

[Skeptic Ginger]

Once more, there is no issue here. It's a handful of narcoleptic cases out of millions and millions of vaccine doses. If anything, blocking a product's market on such flimsy evidence is the outrage. While it may be prudent if one product is riskier than alternative products, but it may also be doing tremendous additional damage convincing the public the flu vaccine is dangerous and unnecessary.

 

[Mirrorglass]

Once more, there is no issue here. It's a handful of narcoleptic cases out of millions and millions of vaccine doses. If anything, blocking a product's market on such flimsy evidence is the outrage. While it may be prudent if one product is riskier than alternative products, but it may also be doing tremendous additional damage convincing the public the flu vaccine is dangerous and unnecessary.

Well, that's a different issue.

The evidence is indeed flimsy; it is starting to look like the whole thing will blow over as a fluke. But the numbers are not insignificant; the expected incidence of narcolepsy in our population tripled among the vaccinated children during this year. If it turns out to be caused by the vaccine, it's a rare side-effect, but most certainly not an insignificant one.

Still, the decision to stop the vaccinations would have been the wrong one if we were still in the middle of the pandemy, or expecting a new wave immediately. But that isn't the case; a large portion of the populace is already vaccinated, and there is enough time to get another vaccine to administer to the rest, if need be.

The media outrage is extremely unfortunate; I have no doubt people will be more hesitant to take influenza vaccinations in the future, no matter what the outcome of the investigation is. However, continuing the vaccinations while there are suspicions of serious side-effects would have done far more damage to the trust placed on the health care authorities here. If the main concern is convincing the public, that would have been a very poor strategy.

 

[Infoexcavator]

The official investigation into this should be released any time now, I am interested in the findings.

Here is the article in English from THL http://www.thl.fi/en_US/web/en/pressrelease?id=24103

-Vaccine has directly caused narcolepsy, correlation is so strong that it is unlikely it could be anything else.
-Normally 5-10 cases per year in Finnish kids , after vaccinations 60 cases of which 52 had the vaccination.
-Some unknown factor increased the risk in Finland, Sweden and Iceland.

 

[Beerina]

So there's an outbreak of a disease known to be a contributing factor to narcolepsy (according to the article in the OP). A vaccination program is started. Narcolespy cases increase. Therefore it must have been the vaccine? Perhaps I'm missing something, but that doesn't seem to be the obvious conclusion to jump to.

Assume 100% correlation. The answer is still not clear on what to do, or whether what they've done is proper. For every million vaccines, X lives are saved, but Y get narcolepsy. What's the trade-off ratio? Certainly if X > Y, it's worth it, even allowing for the occasional narcolepsy-induced death (say, while driving.)

Is preventing 1 death worth 15 cases of narcolepsy?


It's the same possible error that makes me view the FDA with a jaundiced eye -- are all the deaths they've prevented actually greater than the inevitable deaths caused by delaying a highly useful cancer or heart disease (or AIDS, for that matter) drug to market by a single year? If not, the FDA's a net murderous killer. The road to Hell...

 

[Kuko 4000]

http://www.ema.europa.eu/ema/index....ts/news_and_events.jsp&mid=WC0b01ac058004d5c1

European Medicines Agency recommends restricting use of Pandemrix

The CHMP considered that the epidemiological studies relating to Pandemrix in Finland and Sweden were well designed and the results show an association between Pandemrix vaccination and narcolepsy in children and adolescents in those countries. The results indicate a six- to 13-fold increased risk of narcolepsy with or without cataplexy in vaccinated as compared with unvaccinated children and adolescents, corresponding to about an additional three to seven cases in every 100,000 vaccinated subjects. This risk increase has not been found in adults (older than 20 years). A similar risk has not been confirmed but cannot be ruled out in other countries.

The Committee noted that the vaccine is likely to have interacted with genetic or environmental factors which might raise the risk of narcolepsy, and that other factors may have contributed to the results. There are several initiatives being developed across the EU to further investigate this association.

The CHMP noted that similar epidemiological studies have not been completed in other countries. The preliminary results of the VAESCO study confirmed the signal in Finland. Results are still preliminary and do not allow conclusions in other countries (where vaccination coverage with Pandemrix was lower), but the final results of the VAESCO study are still awaited.

Exposure to specific infectious diseases (including H1N1) at different ages, particularly upper respiratory infections, may have contributed to the observations in the Nordic area. The CHMP considered that it would be helpful if ongoing epidemiological studies seek to address this question.

Hmmm:

Exposure to specific infectious diseases (including H1N1) at different ages, particularly upper respiratory infections, may have contributed to the observations in the Nordic area. The CHMP considered that it would be helpful if ongoing epidemiological studies seek to address this question.

Are there any ways to know whether the children had H1N1 or not? I would think that this is a very important point.

In any case, this is the official word, there was a link between the Pandemrix vaccine and narcolepsy:

The results indicate a six- to 13-fold increased risk of narcolepsy with or without cataplexy in vaccinated as compared with unvaccinated children and adolescents, corresponding to about an additional three to seven cases in every 100,000 vaccinated subjects.

 

[Kuko 4000]

http://www.yle.fi/uutiset/news/2011...rms_vaccine_link_with_narcolepsy_2739153.html

The European Medicines Agency has linked the swine flu vaccine Pandemrix to narcolepsy, backing the results of Finnish and Swedish research.

 

[casebro]

Hmm, so there is some kind of link between viruses and narcolepsy?

Hmmm, could that mean there could be a link between viral exposure and other brain problems?

Or maybe the links could be to general immune activity?

 

[MaxMurx]

To be boostered or not to be boostered?

You must be aware that there were two different types of vaccines. One contained the full amount of antigen to trigger immune response, the other contained 30%-50% of antigene plus an aluminium phosphate based "immune booster" substance. When the vaccine was distributed during the swine flue epidemy, the safety studies for that booster were far from being completed in all patient populations. In particular it was not known to which extent auto immune diseases would be "boostered" in parallel or would become apparent for the first time, mainly in younger patients. The producers obliged the governments of all countries were the boostered vaccine was distributed to keep them free from all civil or criminal liabilties. The full vaccine was sold in the USA and France, the boostered one in Germany and some other countries, which I am not aware of in detail. My choice and advice (as a German physician) was: take the flue. The symptoms you refer to might be related to that agent, as similar symptoms are known since long time: http://www.whale.to/vaccine/west_edda.html

 

[Tracy Dalziel]

You must be aware that there were two different types of vaccines. One contained the full amount of antigen to trigger immune response, the other contained 30%-50% of antigene plus an aluminium phosphate based "immune booster" substance. When the vaccine was distributed during the swine flue epidemy, the safety studies for that booster were far from being completed in all patient populations. In particular it was not known to which extent auto immune diseases would be "boostered" in parallel or would become apparent for the first time, mainly in younger patients. The producers obliged the governments of all countries were the boostered vaccine was distributed to keep them free from all civil or criminal liabilties. The full vaccine was sold in the USA and France, the boostered one in Germany and some other countries, which I am not aware of in detail. My choice and advice (as a German physician) was: take the flue. The symptoms you refer to might be related to that agent, as similar symptoms are known since long time: http://www.whale.to/vaccine/west_edda.html

Haven't Aluminium salts been used as adjuvants for decades ?

 

[Skeptic Ginger]

....similar symptoms are known since long time: http://www.whale.to/vaccine/west_edda.html

That website is a completely discredited unscientific source of bad medicine/bad science. The sources they cite are no more than opinion and fear mongering pieces.

The article cites one real study and they exaggerate the significance of it.

 

[Skeptic Ginger]

Haven't Aluminium salts been used as adjuvants for decades ?

Yes.

Aluminum adjuvants have a demonstrated safety profile of over six decades with the exception of rare allergic and local reactions.

 

[Skeptic Ginger]

Aluminum Adjuvants in Vaccines

Macrophagic Myofascitis
Macrophagic myofascitis (MMF) is a term that is used to describe some findings that have been seen microscopically in some muscle biopsies. The lesions are thought to be caused by tissue changes resulting from the normal immune response to the aluminum-adsorbed vaccine.9

The biopsy findings were originally described in a group of French adult patients who had muscle and joint aches and pains and fatigue.10 Although France is the exception, biopsies of muscle are not usually performed on muscles of the arm because that is where vaccines and other shots are often given. In addition, because muscle biopsies are quite painful, muscle biopsies are not performed on normal people—that is, there are no normal control muscle biopsies with which to compare the French patients’ biopsies.

Although the physician who first described the biopsy findings proposed that the aluminum-containing vaccines caused the symptoms in his patients10, most scientists believe that the tissue findings showed the normal response to the aluminum adjuvant; and many felt that the patients’ illnesses did not warrant the performance of a muscle biopsy.11

I should point out that this finding was described in 1998 and in the ensuing decade nothing has come of the finding.

 

[Skeptic Ginger]

Adverse events after immunisation with aluminium-containing DTP vaccines: systematic review of the evidence

We have reviewed evidence of adverse events after exposure to aluminium-containing vaccines against diphtheria, tetanus, and pertussis (DTP), alone or in combination, compared with identical vaccines, either without aluminium or containing aluminium in different concentrations. The study is a systematic review with meta-analysis. We searched the Cochrane Vaccines Field Register, the Cochrane Library, Medline, Embase, Biological Abstracts, Science Citation Index, and the Vaccine Adverse Event Reporting System website for relevant studies. Reference lists of retrieved articles were scanned for further studies. We included randomised and semi-randomised trials and comparative cohort studies if the report gave sufficient information for us to extract aluminium concentration, vaccine composition, and safety outcomes. Two reviewers extracted data in a standard way from all included studies and assessed the methodological quality of the studies. We identified 35 reports of studies and included three randomised trials, four semi-randomised trials, and one cohort study. We did a meta-analysis of data from five studies around two main comparisons (vaccines containing aluminium hydroxide vs no adjuvant in children aged up to 18 months and vaccines containing different types of aluminium vs no adjuvants in children aged 10–16 years). In young children, vaccines with aluminium hydroxide caused significantly more erythema and induration than plain vaccines (odds ratio 1·87 [95% Cl 1·57–2·24]) and significantly fewer reactions of all types (0·21 [0·15–0·28]). The frequencies of local reactions of all types, collapse or convulsions, and persistent crying or screaming did not differ between the two cohorts of the trials. In older children, there was no association between exposure to aluminium-containing vaccines and onset of (local) induration, swelling, or a raised temperature, but there was an association with local pain lasting up to 14 days (2·05 [1·25–3·38]). We found no evidence that aluminium salts in vaccines cause any serious or long-lasting adverse events. Despite a lack of good-quality evidence we do not recommend that any further research on this topic is undertaken.

 

[Kuko 4000]

My choice and advice (as a German physician) was: take the flue.

Really? I'd like to hear your comments about this graph:

http://cdc.gov/flu/weekly/weeklyarchives2009-2010/images/IPD20_small.gif

 

[bjornart]

I might be off, due to insufficient data, but I think this link, while possibly a sensible precautionary hypothesis, will have less and less scientific support as time goes by.

As I understand it narcolepsy is:
a) Rare
b) Relatively unknown to the general public and general physicians, at least before this scare
c) Difficult to diagnose (at least in milder forms and without cataplexy)
d) And because of this, at least before this, it was often years between onset of symptoms and diagnosis.

So at least some of the cases this conclusion is based on are likely to be "ordinary" cases discovered early because of an increased awareness.

It's even possible that the remaining cases are a statistical blip, or have other causes and only a coincidental correlation, although I concede the data may already prove me wrong on that since I haven't seen them and don't qualify to analyse them.