Thursday, 29 March 2012

NICE & CCSVI


NICE interventional procedure guidance 420. Percutaneous venoplasty for chronic cerebrospinal venous insufficiency for multiple sclerosis Issued: March 2012.



Current evidence on the efficacy of percutaneous venoplasty for chronic cerebrospinal venous insufficiency (CCSVI) for multiple sclerosis (MS) is inadequate in quality and quantity. Therefore, this procedure should only be used in the context of research.


NICE encourages further research on percutaneous venoplasty for CCSVI for MS, in the form of robust controlled clinical trials. Studies should clearly define selection criteria and patient characteristics. They should also clearly define technical success which may include measurement of pressure gradients across treated vein segments before and after venoplasty. Outcomes should include clinical and quality of life measures.




"Spot on! I have been calling for this since the CCSVI issue arose. We need well designed clinical trials - not open labelled studies - but double-blind sham-controlled randomised studies. Nobody with MS should be paying for an unproven therapy. If you volunteer for trials it should be open and informed; you should sign a consent form. Even your travel costs should be covered. You should not be out of pocket. Don't forget this. There are too many Charlatans out there wanting to make money!" 


22 comments:

  1. Pity NICE didn't comment on Zamboni's conflicts of interest in relation to his CCSVI theory. If they did general readers would be aware that they may be dealing with another Wakefield/MMR scenario.

    The fact that Zamboni stood to benefit financially from CCSVI casts a huge shadow over the field and raises the issue of whether or not his work is fraudulent.

    Prof G, would you agree with this?

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  2. NICE encourages doctors to offer the treatment as part of research studies in order to explore its impact on patients. There is no limitation to placebo-controlled trials.

    Therefore, NICE accepts CCSVI as a pathology and foresees a possible connection to neurological symptoms. Using the word "scam" to describe CCSVI now equals ignorance of the matter.

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  3. Re: "Therefore, NICE accepts CCSVI as a pathology and foresees a possible connection to neurological symptoms."

    Unfortunately, NICE have no medical philosophers on their panel and it is clear they have no idea how we, the medical profession, define a disease. A disease is defined as a clinico-pathological correlate. CCSVI is not close to receiving this status; firstly, the evidence that it is clinical entity is debatable and there is no pathological correlate.

    I will, when I get the time, do a separate posting on defining a disease to clarify this point!

    I suggest you and NICE read Ludwig Wittgenstein, the philosopher! Disease classification is based on his writings.

    http://en.wikipedia.org/wiki/Ludwig_Wittgenstein

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  4. Re: "Prof G, would you agree with this?"

    Without a full investigation into the research, with an onsite audit, you cannot make the claim that his work is fraudulent. However, his results are clearly an outlier (simply to good), which makes one suspicious.

    I agree about the issue of conflict of interests. If we knew about them we would have interpreted the results and his comments very differently. Conflicts are a natural counter to over interpretation of comments. I don't have a problem with conflicts of interest if they are declared and are transparent. In the UK politicians usually have to resign if they are caught not declaring conflicts. We take them very seriously.

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  5. Dear Anon – FYI:

    'Esaote has merely provided equipment to his lab and funded professional training, and he (Zamboni) has no plans to commercialize the inventions described in the patents, he said in an emailed response to questions.’

    It seems he made an error in not saying this at the time, but it is hardly an earth shattering scandal.

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  6. "Spot on! I have been calling for this since the CCSVI issue arose.”

    I’ve always considered you a tireless campaigner for the instigation of CCSVI trials. I thought the way your colleague Dr Schmierer labelled CCSVI as ‘a distraction’ at the 2010 Research Day was a beautifully subtle way of doing this.

    The vast majority of people with an interest in the potential of this treatment for CCSVI have wanted trials to take place. This is obvious. The point is that we are two and a half years down the line and nothing close to this is happening in the UK.

    Sadly, over the last two years, many of us couldn’t even have a reasonable discussion about this topic with our neurologists without risking a dismissive tirade.

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  7. Re "Disease classification is based on his writings."

    Seems like Wittgenstein's "family resemblances" could be applied to incorporate CCSVI as well. But the trend among CCSVI researchers is towards defining it as a syndrome, not a disease.

    Re "NICE have no medical philosophers on their panel"

    I would like to follow the philosophical path with you. In that case we must begin from the basics and apply Occam's razor on the volume of necessary conditions posed by the autoimmune, viral and vascular hypothesis for the emergence of MS.

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  8. Maybe Prof G would like to follow the path, I do not have the time

    You (vv) said you had a blog maybe follow the path there and send the link and then we can walk with you on that path..

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  9. "You (vv) said you had a blog maybe follow the path there and send the link and then we can walk with you on that path.."

    Yeah, post the link VV and we can all walk hand in hand to the land of delusion!

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  10. Now given that there are three or four trials in place do you think that the uk should be spending money doing another one. Only about a few hundred or so people would get active treatment. The other trials will be reporting their results before a uk trial would get off the ground. Money spent on this trial would no doubt dent their capacity to move forward with plans for progressive ms. Money is limiting.

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  11. Hi MouseDoctor,

    ‘Now given that there are three or four trials in place do you think that the UK should be spending money doing another one.’

    This largely depends on whether NICE are closely monitoring these current international trials and, if so, intend to act swiftly on their results.

    The chairman of the NICE report was on Radio 4 yesterday and it seemed like the news of the placebo controlled study going on in Buffalo was new to him. I hope I misinterpreted this and that his ear is a bit closer to the ground. Maybe he should use Google to find out current information on CCSVI, although I hear that’s not as popular as it used to be…

    ‘The other trials will be reporting their results before a UK trial would get off the ground.’

    This is true. My previous comment was more about the time that has been wasted on words and lack of action in this country to get us to this point. NICE could have issued this guidance 18 months ago, maybe at least that would have made discussion about this treatment a bit less polarized.

    If there was a small scale UK study it would allow some of the neuro-sceptics to gain a closer understanding of the procedure and it’s outcomes. The recent studies presented at the ‘International Symposium on Endovascular Therapy’ found that PPMSers also benefited, so I don’t think it’s robbing Peter to pay Paul.

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  12. Maybe NICE should also be funding a study on homeopathy for MS too?
    Money is short and we can't afford to endlessly repeat a dodgy study to produce negative results.
    No matter how many studies are done, the truthers will never accept the negative conclusions.

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  13. Re "Money spent on this trial would no doubt dent their capacity to move forward with plans for progressive ms."

    What kept you so long? CCSVI is around 3 years only. Ah, i forgot, you had to check the long term efficacy of interferon-B in RRMS.


    Re "Yeah, post the link VV and we can all walk hand in hand to the land of delusion!"

    No need. You are already there.

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  14. John

    If trials are positive, rest assured NICE will hear about and the MS Societies will be lobbying for it to become available

    I don't think that a trial in the UK will convince the neuro-sceptics ....positive results will.

    A lot of the time has been wasted trying to establish whether the phenomenon really exists because it is hard to treat something that you can not monitor.

    Trials are ongoing if the results are so startling it should not take that long to find them.

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  15. Forgot you have to check long term efficacy of IFN in RRMS

    What has this got to do with the CCSVI debate?..absolutely nothing!
    It also has no relevance to funding a CCSVI study.

    What kept YOU so long...It you think I can do a trial then you need more education of what undertaking a trial involves or am I responsible for everything the MS research community do?


    How long do you think it takes to get ethics and funding in place for trials even if you want to do it?

    Grant applications take 6-12months to get funding and then there are loads of other things to do, it is not as simple as you make out.

    Still no link otherwise you may be walking by yourself.

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  16. YOU is plural.

    Re "Still no link otherwise you may be walking by yourself"

    The blog is in the language of walking philosophers. I doubt you can follow it.

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  17. Vasilis I'm confused - didn't you say trials are premature and are being done only to satisfy neuros who demand evidence?

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  18. Anonymous, I said placebo-controlled studies are premature, but research studies without placebo arm are necessary to explore the full extend of CCSVI. There is no contradiction.

    The rush for placebo-controlled studies is largely due to neuro-reluctance to accept CCSVI as a pathology common in MS patients.

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  19. The blog is in the language of walking philosophers. I doubt you can follow it.

    So total cack then.

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  20. Nice vocabulary, MD. Just what your readers need.

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  21. "The blog is in the language of walking philosophers".

    Does that mean that philosophers in wheelchairs are unwelcome?

    from
    Harry Stottle

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  22. "The blog is in the language of walking philosophers. I doubt you can follow it."

    But we all have Doctorates in Philosophy!

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