Friday, 6 July 2012

Hepatitis B vaccination and MS

Rougé-Maillart et al.  Recognition by French courts of compensation for post-vaccination multiple sclerosis: the consequences with regard to expert practice. Med Sci Law. 2007 Jul;47(3):185-90. 

Despite scientific uncertainties, French courts have awarded compensation to MSers. which occurred following vaccination against hepatitis B. These legal decisions have aroused fierce criticism in the medical world. Both a judgment given on 25 May 2004 by the Court of Cassation and a new publication in the journal Neurology have encouraged us to look once more at this controversial issue. French judges began compensating MSers at the end of the 1990s. One of the first judgments was given in 2001 by the Court of Appeal of Versailles when a pharmaceutical laboratory was held liable for the onset of MS following vaccination against hepatitis B. On appeal, the Court of Cassation overturned the judgment in September 2003, finding that the Court of Appeal judges had based their decision on a hypothetical causal link. However, the only reason why the Court of Appeal judgment was quashed was the contradictory evidence on which the judges had based their presumptions. Several of the judgments given since that date seem to confirm this hypothesis. On 25 May 2004, the 2nd civil law chamber recognized that MS which occurs following a vaccination against hepatitis B (a vaccination carried out for work-related purposes) could be considered as an accident at work, without questioning the possible causal link between the illness and the vaccine. This jurisprudence in the matter of hepatitis B vaccination shows the need for great care in expert practice. Effectively, when confronted with drug related imputability, the expert usually bases his reasoning on three points: the causal role of the generating factor, the chronology and other causes of damage. In terms of MS, all these factors are modified. More than ever, an expert must, in terms of imputability, be objective, prudent and clear in his conclusions.

"This abstract summarises the problem; the legal system applies the principal of 'beyond reasonable doubt' and hence often award compensation when the scientific evidence does not support the claim. How do you disprove something in a court of law? You don't; you simply create enough uncertainty, or certainty, and jury and/or judge will have doubts and rule in your favour."

"The majority of scientists and MSologists accept that there is no causal link between hepatitis B vaccination and MS. There may be some laggards, who believe the contrary, but there always are. However, try telling someone who develops MS shortly after a vaccination that there is no causal link; in their minds it is causal. In my opinion it is probably a coincidence; but I can't categorically say that in that particular individual the attack was not precipitated by the vaccination. This is why I am very careful how I counsel MSers about the risks and benefits of vaccination in general. I choose my words very carefully and make sure they understand the uncertainty."

"Please note that every vaccine is different; so what applies to Hep B cannot be applied to yellow fever, polio, MMR, etc."

15 comments:

  1. I am the guy who posted that I was vaccinated at Soho in June 09 and had a CIS in Aug 09.
    I called the vaccination center in December asking the manager why I had not been informed about this risk. He said that the studies are not conclusive.

    Well, I am no ambulance chaser but my case is solid enough to warrant a court hearing.

    The idea of suing the NHS in UK courts is daunting though....

    why not doing a survey to figure out how many of the MSers are vaccinated to start with?

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  2. I did some research and found this:

    http://www.ncbi.nlm.nih.gov/pubmed?term=oldstone%20hepatitis%20B%20and%20Myelin

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  3. p.s. I don't believe in coincidences.

    So many cases around the world.

    If they had not found a link yet does not mean that there is no link!

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  4. I found this.

    Yep Hepatitis and myelin basic protein sequences.

    The evidence that MBP is an really autoantigen in MS is not good.

    I am sure you could find paper with hepatitis sequences and diabetes and arthritis.

    You could find link EBV and MBP etc.

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  5. what about this:

    http://www.bmj.com//content/329/7468/703.2?variant=extract

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  6. The link posted by Anon 12:19 (albeit an abstract only) is fairly straight forward.

    Can one sue on the back of this? Any lawyers around?

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  7. Firstly, it is very important to get lot number of vaccine, which the GP should have in your records.

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  8. Litigation based of what can only be described as flimsy evidence benefits no-one except the lawyers and is just yet another example of blame culture similar to the MMR/autism debacle of a few years back.

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  9. ...you scientists and clinicians are just scared to look into it as you fear for your careers. HepB vaccination may turn out to be a risk factor for MS and if we need lawyers to proof it, so be it !

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  10. Since about 1990 HEP B vaccinations are given to all infants in south-east Asian countries, where MS is very uncommon.
    I don't think there is any spurt in MS yet

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  11. Mousdoctor, we need you! Have you not mentioned before that south-east Asians are not as susceptible to MS as Europeans?

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  12. Re: "...you scientists and clinicians are just scared to look into it as you fear for your careers. HepB vaccination may turn out to be a risk factor for MS and if we need lawyers to proof it, so be it!"

    The evidence is to the contrary; there is no evidence that Hep B vaccine causes or triggers MS. Lawyers seldom prove anything; they typically create doubt that is sufficient to convince a jury or judge. "Beyond reasonable doubt" is simply not good enough for scientists.

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  13. Re: "If they had not found a link yet does not mean that there is no link!"

    The studies are large, reproducible and in my opinion definitive. At some point we have to accept the evidence; spending more money on this is unlikely to change things. The money would be better spent on a progressive MS study.

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  14. Dear Prof,

    A question regarding the vaccine. I had a symptomatic CIS over 4 years ago with periventricular features suggesting demyelination on MRI.
    However, due partly to my adolescent age and having just 2 or 3 lesions the neurologist certainly did not decline to rule out the possibility of a monophasic episode.

    After 3 years there was no change radiologically and nothing new clinically now 4 years on, leaving a truly monophasic possibility still open.

    However, my dilemma is that I would like to study medicine so would need the shots, and after reading the 2 scary studies(Hernán,Yann Mikaeloff)that favor this so called association am a bit concerned about receiving the vaccine.

    Although I realise the weight of the evidence probably rejects such a causation in simple terms, given my unique demyelinating situation (which has so far behaved so well), would it be a sensible move to have the vaccine in your opinion?

    I fear it may trigger something that is currently destined to either never develop or develop after many years. Maybe I should just avoid the recommbinant or engerix B brand? What would you do?

    Thanks!

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    Replies
    1. I can't make this call for you. The evidence suggests hat Hep B vaccination is safe.

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