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New Exercise Study Brings Both Illumination and Questions
Simon McGrath looks at new objective evidence of abnormal response to exercise in ME/CFS patients, and the questions that researchers are still trying to answer ...
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  1. bananaman

    bananaman

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    Hi guys im from the UK, This may be the million dollar question but is there any indication as to when a decision may be made on Ampligen getting a drug licence for ME/CFS in the USA?!

    thanks all, Dave.
  2. Cort

    Cort Phoenix Rising Founder

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    Our first post! I talked with Mary McGorty - the public relations person for Hemispherx - at the CFSAC meetings. She shows up for all of them by the way - she's very active.

    The deadline for Ampligen was pushed back again - the second time this year - but not because of anything Hemispherx did - the FDA is just swamped apparently. It hasn't helped that Ampligen has bounced around different departments at the FDA as they tried to figure out what kind of disease ME/CFS is. Mary did tell me, though, that FDA researchers had checked out all the different facilities and they checked out fine.

    When they'll make a decision, though, is anyone's guess - hopefully sooner rather than later.

    Thanks for the first post!
  3. Cort

    Cort Phoenix Rising Founder

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    Ampligen was back in the news. Apparently we should know in just be a few weeks. A Business correspondent, though, just reported that Dr. Bell, the head of Hemispherx, is back up to his old tricks - over stating results, recycling old research as if it was new. Hemispherx has a terrible reputation that's for sure but it'll be such an ace for us if FDA approves. I talked with Kim McCleary and the subject of Hemispherx briefly came up - she didn't say much the tone in her voice!!! Their liason Mary McGrorty is great though.


    http://aboutmecfs.org/Trt/AmpHist.aspx
  4. Michael Dessin

    Michael Dessin Senior Member

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    Would be a great benefit if it we're approved..so much politics and red tape. Could this be the time?...I hear within 10 days a decision should be made...but we've heard this many times before :mad:.....Mike
  5. Cort

    Cort Phoenix Rising Founder

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    10 days! they must be sweating bullets over there. Their stock is in the dumps. If it doesn't go through I wonder if the company is finished.

    The mantra has always been good product - bad company. At the last CFSAC meeting I talked to Kim McCleary and for some reason Hemispherx came up. I could hear the distaste in her voice.

    Still if it goes through what a windfall for ME/CFS; recognition of it as an immune disease - more legitimacy - treatment option that definitely helps some people very much. Apparently the drug companies were shocked, absolutely shocked at the demand for Lyrica for FM patients.

    Crossing my fingers! Ten days - after almost 20 years - ten days!
  6. Michael Dessin

    Michael Dessin Senior Member

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    Again

    Guess FDA pushed it back again, winter? Hmm maybe winter 2013 at this rate. Horrible!!
  7. hvs

    hvs Senior Member

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    If the FDA approves Ampligen it necessarily subscribes to the view that CFS has a viral root (or driver which, once put to bed, allows recovery). (For the core Incline Village subset, this is absolutely true.)

    If it does that, it puts it at odds with the CDC which has been covering its failure to identify the role of viruses for 25 years.
  8. hvs

    hvs Senior Member

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    I agree that viruses might merely be the driver for something that might have a root in genes, but in that case don't you think we shouldn't see it in outbreaks or in families?
  9. Cort

    Cort Phoenix Rising Founder

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    I don't know if this was posted elsewhere or not: From Adam Feurstein - someone who's been all over Hemispherx - he doesn't trust them and he's after them.

    It looks like Hemispherx could be having problems meeting FDA standards for manufacturing.

    http://www.thestreet.com/_yahoo/story/10597681/1/hemispherx-hasnt-called-fda-on-ampligen-review.html

    Hemispherx Hasn't Called FDA on Ampligen Review

    HEB , AMAG Adam Feuerstein


  10. dannybex

    dannybex Senior Member

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    I posted another article...

    ...from Feurstein on the Ampligen approval thread in the General News section:

    http://forums.aboutmecfs.org/showthread.php?t=172

    At that point he didn't think it would ever get approved, because they kept fudging/changing the study's data...from 17.4, then 19.3, to finally a 12.9 percent improvement:

    Quoting Feurstein:

    "The abstract clearly states that the 12.9% improvement in exercise performance between Ampligen and placebo patients was not statistically significant, with a p value of 0.052. Any result with a p value of greater than 0.05 is deemed not statistically significant.

    Simply put, Hemipsherx's phase III study of Ampligen in patients with CFS was a failure."

    http://www.thestreet.com/story/10506671/1/hemispherxs-cfs-drug-is-a-long-shot.html

    Personally, even though it's been a (temporary) life-saver for some patients, I don't think it'll be approved because of it's checkered past, but mainly because of it's exorbitant cost, especially compared to other immune modulators...
  11. hvs

    hvs Senior Member

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    I think part of the point of WPI's interest in translational medicine is that they will identify which patients will benefit from which therapies. It'd be good to have ampligen available to them to give to targeted patients. There's little question that ampligen's helped a good number of people who came out of remission when the drug was taken away.
  12. Scavo86

    Scavo86 Senior Member

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    Is it still possible to get Ampligen in Belgium and, if so, where does one go? Secondly, who do us UK lads and lasses lobby if we would like to see a trial over here? Thanks in anticipation of the answers guys :D
  13. garcia

    garcia Aristocrat Extraordinaire

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    Anyone know the answer to the above? Is Ampligen available in Europe at all? If so, where?

    many thanks,
    garcia.
  14. Daffodil

    Daffodil Senior Member

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    i would call dr. demeirleir's office and ask the secretary if he is still using ampligen or where to get it:

    Phone: +32 2 481 53 10
  15. grant107

    grant107 Jean

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    Does anyone know when the studies will be completed? I think it is time the fda approved this drug.
  16. BEG

    BEG Senior Member

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    I believe this drug is not the panacea that many think it is. (Except for Mary Schweitzer) I was in a Phase III trial and had to drop out because I was allergic, but I kept in contact with a couple of fellow patients. If there was a miracle in my group, I never heard about it.
  17. LaurelW

    LaurelW Senior Member

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    Yes, there are a lot of people that don't respond to it. Researchers need to look into other drugs.
  18. Sunshine

    Sunshine Senior Member

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    Hi. Looking back a decision was due to be made by summer 2009 (in Europe) on Ampligen being allowed into Europe to treat CFS. In 2008 there was real hope Ampligen may well pass EU laws. No news being released on the matter since means Ampligen must have been refused on safety grounds in the EU as the FDA blocked it in America and the EU officials would have cited this.

    The last time Ampligen was blocked by the FDA it showed a very small increase in V02 max function (exercise testing) in American patients with CFS. Presumably not enough to demonstrate Ampligen to be classed as a licensed drug and/or it was denied due to political reasons.

    More positively I heard there was going to be or there is ongoing?...... an Ampligen trial in CFS in America measuring Natural Killer Cell function in those who are XMRV+. If NKC function was demonstrated to be improved, there would be grounds for Ampligen to be allowed as an immune drug for improving NKC function in XMRV rather than as a therapy for CFS which is wrongly accused of being a psychosomatic lifestlye choice by the CDC. and UK National Health Service.

    the American FDA classifying Ampligen as an immune modulator for XMRV (rather than CFS) would allow the American government/FDA to save face and deny any link of CFS being any form of immune disorder yet simutaneously finally allow Ampligen to be passed for 'other conditions'. Also this way the CDC could still deny CFS is anything to do with impaired NKC function, despite the overwhelming scientific evidence. Again this would be done by only allowing the drug to be used for XMRV+ with NKC depletion, and not anyone with the label CFS.

    This is currently the best we can hope for, yet within 3-5 years I imagine the WPI will have something up their sleeves for us in term of basic non antiretroviral drug treatment for neuro immune CFS.

    It's a great shame Ampligen never came to Europe in 2009, and only continues to be used in America by around 4 named individuals. 4 doctors, for 17 million people at up to $20,000 per year for the IV drug rarely works out as an effective way to attempt a basic treatment for a chronic disabling organic disease in persons with very low incomes due to severe disabilty and social exclusion.
  19. heapsreal

    heapsreal iherb 10% discount code OPA989,

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    australia (brisbane)
    i think improving natural killer cell function is going to be our answer as alot of our infections i believe are opportunistic, even if xmrv is the cause, good nk cell function will help keep a lid on it. Poor nk cell function could/should almost be a diagnostic tool for cfs.
    Has there been any recent studies on immunovir and nk cell function, as this is a cheaper drug and easier access to most of us now then ampligen, although ampligen appears to be alot stronger.
  20. garcia

    garcia Aristocrat Extraordinaire

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    In Japan ME/CFS is more popularly called Low Natural Killer (cell) Sydrome (LNKS).

    Unfortunately I'm already on imunovir, and whilst it has helped somewhat, it is very very far from being any type of cure.

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