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ME/CFS: A disease at war with itself
We can all agree that ME/CFS is a nasty disease, particularly in its severe form, but there are abundant nasty diseases in the world. What is unique and particularly confounding about our disease is that so much controversy surrounds it, and not only surrounds it, but invades it too.
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Ampligen approval granted extension by FDA

Discussion in 'General ME/CFS News' started by Nielk, Jan 11, 2012.

  1. snowathlete

    snowathlete

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    Maybe it is difficult to prove its working, for whatever reason, and a test would help them prove it. If you can test for the illness, then treat and test again and its gone, then thats pretty solid(so long as the test is solid) and maybe thats cheaper than doing a massive trial and trying to show the results prove hte drug works. Perhaps because of the trouble in picking for sure, people who have the illness without doubt?

    Just an idea.
  2. Firestormm

    Firestormm Guest

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    27 September 2012: The Street: http://www.thestreet.com/story/11720256/1/hemispherxs-ampligen-rehash-unlikely-to-impress-fda.html
  3. Firestormm

    Firestormm Guest

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    There's a more positive analysis of Ampligen, Hemispherex and the need of a drug for CFS/ME here:

    Can Hemispherx Find Success In The Chronic Fatigue Market?

    Seeking Alpha: October 1st 2012: http://seekingalpha.com/article/898091-can-hemispherx-find-success-in-the-chronic-fatigue-market

    justy likes this.
  4. Shell

    Shell Senior Member

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    I would love to believe that both Ampligen and Rituxin could be genuine answers for us - but I'm both cautious and cynical.
    I did love that link to TheGlass Mountain blog. She talks of taking a 30 minute walk!!!! That little sentence alone is so wonderful!
    Nevertheless Firestorm's observations leave me thinking there isn't as much hope as we might like.

    As for either of these drugs being available of the NHS, I just can't see it. Apart from the egos that would be damaged the NHS is crap at funding proper medical care and spends it's money of managers and faff.
    Firestormm likes this.
  5. Firestormm

    Firestormm Guest

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    Morning Shell,

    Yes I am unsure of what would happen in the UK if the FDA approves this drug. Would the MRC (?) then need to do a clinical trial themselves for example? I doubt that FDA approval is sufficient for other countries but it would mean something.
  6. In Vitro Infidelium

    In Vitro Infidelium Guest

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    FDA is US only - and then of course there would be a question of whether/what Insurance would cover in the US. For the UK a licence would be required either from MHRA or EMA, both have their own strict criteria to meet. Safety studies carried out, outside of Europe may often be accepted, so long as those studes meet the relevant critieria, but the fact of FDA approval would not of itself be material to either MHRA or EMA approval. For the UK there is then the further test in respect of NHS availability and although that woud not directly impact private treatment, it does in practie influence what private insurance may cover.

    Patient group lobbying for drug approval has long been an aspect of US Pharmaceutical marketing, a practice that has spread to Europe http://www.nytimes.com/2009/10/22/health/22nami.html?_r=0 and http://euobserver.com/news/29934 . It's not unknown for lobbyists to use the internet to present themselves as patients and act as cheerleaders for drug approval campaigns, the FDA has likely become somewhat resilient to patient lobbying because of doubts about the validity of what/who is driving patient demand.

    IVI
    Firestormm likes this.
  7. In Vitro Infidelium

    In Vitro Infidelium Guest

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    That's not an unexpected perspective for those of us who have conditions which the NHS doesn't deal well with - but we are a minority in a system created to address the mass needs of the majority. The NHS is and always has been the most efficient deliverer of health care of any large developed country. Not wholly current but a simple presentation http://www.commonwealthfund.org/Pub...omparative-Performance-of-American-Healt.aspx - New Zealand does better on cost overall but population size and age (young and healthy migrant population has a a major impact, plus lack of large cities and industrialisation) changes the context of delivery somewhat.

    IVI
  8. Snow Leopard

    Snow Leopard Senior Member

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    National bodies such as the MRC, generally do an internal review based on existing scientific evidence (including all published RCTs, no matter where they were conducted).

    If Ampligen proves effective to many patients in the USA, the UK will have no choice but to follow. The alternative is to continue to endure the high economic burden of ME/CFS.
  9. Firestormm

    Firestormm Guest

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    I dare say that pending clinical trials in the UK, and subsequent approval, NICE would also have to stick Ampligen in it's Guideline. And then we'd have to ensure that PCT's agree to fund and GPs agree to prescribe.
    Shell likes this.
  10. Shell

    Shell Senior Member

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    I hope it all goes through at some point. My main concern is my children, if this turns out to be either familial or contagious. I would hope they would get better treatment and hope of a cure than us lot.
  11. In Vitro Infidelium

    In Vitro Infidelium Guest

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    NICE has a duty to consider overall costs versus benefits, so Ampligen at current costs would be very unlikely to meet inclusion in Guideline criteria unless it was demonstrably currative or at the very least full pre illness functionality was achieved while treatment was ongoing. Even then as you suggest, local commissioning and prescribing practices would be further hurdles, which would be significant if there were to only be a low level of treatment responders. Ampligen could be demonstrated as both a safe and an appropriate treatment for M.E/CFS and therefore receives MHRA approval and still not be available on the NHS because of cost/benefit or low response rate issues.

    IVI
  12. Mark

    Mark Acting CEO

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    I think the note of caution is probably realistic, sadly, and the NHS is unlikely to approve either Ampligen or Rituximab in the next NICE Guidelines review, even if the FDA has approved it by then, and until there is more trial evidence including about cost/benefit/risk analysis I don't really expect approval. We will be in the ridiculous situation that talk therapies (CBT/GET) that have been proven ineffective for the vast majority of patients will be approved and promoted thanks to manipulated research papers and a relatively large volume of (underwhelming) published literature ("lots of evidence"), while drug treatments that have been proven effective will be unavailable due to a smaller volume of published research and the fact that these treatments - albeit they actually work - cost more than psych treatments and there's not enough published literature on the cost/benefit analysis.

    However, I think that FDA approval of Ampligen would at least oblige the NICE Guidelines review panel to review it as an option and report on that. I think that being forced to look at this evidence would be an eye-opener for some: double-blinded placebo-controlled drug trials that show significant improvement are evidence enough to disprove any thoughts of psychological causation and I think this is evidence that has the power to change individual perspectives on the nature of ME/CFS. I would therefore hope that being obliged to review evidence for Rituximab and Ampligen would force a change in perspective of the NICE guidelines and I would hope at least for a fairly prominent mention of strong evidence of immune or autoimmune problems in many ME/CFS patients.

    FDA approval of Ampligen would really open doors and raise eyebrows and I think it could be a huge step forward for us. We can press for UK trials of both Ampligen and Rituximab, and for more money for ME/CFS research in related areas of medicine (immunology), and with a half-decent campaign these would be hard arguments to resist given the historical low levels of research funding.
    Shell and Valentijn like this.
  13. Shell

    Shell Senior Member

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    Mark
    I would like to believe that if the FDA do approve Ampligen and Rituximab that those sitting in the comfy chairs at NICE would rethink their love of GET/CBT and the whole psychi label thing.
    However CBT is very fashionable in the NHS, regardless of the need or efficacy of it Hence the wait of over 14 months even for people who actually need it.

    The funding for Inferon Beta never happened for us did it?

    Is there even a dim glimmer at the end of the tunnel that getting Ampligen and Rituxin approved in America could eventually get something just a little cheaper like Inferon Beta funded here???
    Frankly, with my 16 years working in the NHS and watching my dh as he continues (now 25 yrs) to work in the NHS, I have very little hope.

    As time goes on and patients on these drugs reach remission or dare I even use the word "cure", then perhaps...And when Wessley and White are retired and gone, and politics and egos are at rest, then, just maybe....
  14. Firestormm

    Firestormm Guest

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    More news and opinion from The Street:

    Hemispherx ATM Withdrawals Raise A Red Flag

    8th October 2012: http://www.thestreet.com/story/11730475/1/hemispherx-atm-withdrawals-raise-a-red-flag.html


    Of course it's 'only' an opinion. Personally I'd be doing exactly what the company appears to be doing: SELLING ME STOCK NOW LOIKE :)

    Not that I'd get 92 cents like they managed. Typical.
  15. barbc56

    barbc56 Senior Member

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    @Firestorm
    This makes me want to read Ben Goldacre's book, Bad Pharma.

    What I like about Goldacre is that he doesn't use sweeping generalizations but uses facts to back up his claims. He uses critical thinking skills/skepticism when he is investigating a subject and goes through the process of how he comes to holding his claims.

    The bolding beow is mine.

    The book is also available on Kindle.

    From the intro:
    I've always kind of cringe at the work skepticism as it may have a negative connotation but this is far from the truth. A definition of scientific skepticism:

    http://scepticism.askdefine.com/

    That's my 92 cents worth.:rofl:

    Barb C.:>)
  16. MR AIDAN G WALSH

    MR AIDAN G WALSH

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    Ampligen is a total hoax, it does not work...Like one doctor said to me one day 'I would not touch Ampligen with a 10 foot pole' you can all wait or scream for Ampligen but you could not pay me money to take this 'lie'...All their research are fabricated lies and I have heard this first hand from former patients...Hem do not care for patients they are cold hearted people interested in increases in company stocks...Nancy Kaiser was the first cfids patient on Ampligen and she is dead today and she told me monster stories about this corrupt company from day one...If Ampligen was such a great spectacular medicine then why was the drug never given the green light on cancer...The biggest investor ever in Ampligen was the inventor of the fax machine and he is dead today and used Ampligen for his cancer but died...Besides if radiation is the actual cause of cfids then the science will prove Ampligen is useless because it will be up to radiation experts now to look at data with regards to Ampligen and say whether it will work or not...It does not work 'PERIOD'
  17. Snow Leopard

    Snow Leopard Senior Member

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    If they aren't doing it to fund another clinical study, then we should be worried...
  18. heapsreal

    heapsreal iherb 10% discount code OPA989,

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    Its probably not everyones cup of tea but people have improved on it. Just like rituximab.

    My doctor told me his work collegue did a small trial on patients in australia in the 1990s, some got very sick on it and never really recovered from this set back. I dont know anymore about it then that.

    Maybe back then and probably now, they need to select the right patients for the right drug with proper subsets and testing to select these patients.

    Now i think if ampligen gets approved and if it helps a large or small number of people, cfs/me is then taken more seriously and recognised by the medical community and the government. Hopefully it spurrs researchers and big pharma to develop more drugs to help treat cfs/me and also those ones who dont respond to ampligen.

    Thats what im hoping comes out of ampligen being approved.
  19. Snow Leopard

    Snow Leopard Senior Member

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    As is, it might only be approved for a subset of patients (eg severe patients). If they can swing $10 million around like this, then surely there is room for more research/additional trial?
    heapsreal likes this.
  20. snowathlete

    snowathlete

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    Another positive factor in our favour (though it may not be enough) is that the first drug that is shown to work, even if only a small improvement, would be considered against the fact there are no alternative drugs yet. NICE do bare that on mind. Of course the biggest thing is that adding it to the guidelines would break their current world view of ME/CFS as a psychological illness and that may stop it happening full stop.

    Once in the guidelines I don't think we will find it too difficult to get prescribed. It's getting it in there that will be the hard part. Of course if Lipkin or others find a bio marker or causive pathogen then that would help. Either way the UK will drag their heels and be behind the US.

    We in the UK will have to campaign like we have never campaigned before if we want to speed things up once a drug is FDA approved.

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