1. Patients launch a $1.27 million crowdfunding campaign for ME/CFS gut microbiome study.
    Check out the website, Facebook and Twitter. Join in donate and spread the word!
Never Ask Us if We're Hungry -- The Answer's Always No
There are three of us here and for many years, none of us ever got hungry. When our brains would turn to mush, when our faces would go numb, and we would start the invisible vibration which is the signature dance of ME/CFS, we knew we needed to eat.
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URGENT: Dec 6 Deadline to email the FDA's Ampligen Advisory Committee

Discussion in 'Phoenix Rising Articles' started by Phoenix Rising Team, Dec 4, 2012.

  1. Phoenix Rising Team

    Phoenix Rising Team

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    View the Post on the Blog
    View the Post on the Blog
    Merry likes this.
  2. Sasha

    Sasha Fine, thank you

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    Thanks, Cort, Bob, and Mark for posting. This is hugely important!

    If the FDA approves Ampligen for the US, then it's a game-changer for patients all over the world. There'll be an effective immune-system drug in use for our disease, which will validate our position that what we have is a genuine immune disorder. We'll be able to petition our governments for Ampligen and other immune drugs, as well as for a serious level of research funding. It will transform the way that the public sees us.

    Please email the FDA, wherever in the world you live. Took me seven minutes!
  3. urbantravels

    urbantravels disjecta membra

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    OK, someone who has looked into the science (no anecdotes please) tell me: How good is the evidence for Ampligen's effectiveness?
  4. Sasha

    Sasha Fine, thank you

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    Hi urban - here's Cort's article on it:

    http://phoenixrising.me/archives/8819

    Good enough for me! :)
  5. SpecialK82

    SpecialK82 Senior Member

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    In the FDA's Advocacy Webinar in Nov, they said that they need to hear from patient groups on how much risk you are willing to take for the potential benefit. They have been swayed before when patient groups have convinced them that they are quite willing to take on risk, a much greater risk than a healthy person may think that they would.

    I made sure to mention that in my email - I said patients have and are comitting suicide, they would be very happy to try a risky drug first. (not that I think Ampligen itself poses much risk)
    Sasha and Little Bluestem like this.
  6. MishMash

    MishMash *****

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    This was a comment by Dr. Van Konynenburg, one of his last, about BG-12, the new MS drug. BG-12 is based on dimethyl fumurate which has been proven effective in psoriasis, in pill form, in Europe as an anti-inflammatory.

    It works against oxidative stress and glutathione depletion, a theory long promoted by Dr. VK. Unlike Ampligen, its efficacy and safety have been replicated in several large, high quality trials. In Germany and at the Cleveland Clinic. This is a proven effective drug against a neuroimmune illness. This should be our first choice for off-label treatment.

    The evidence given by HB for Ampligen is very weak, and results were not replicated. HB has not explained the pathway in which it modulates the immune system. But I believe Ampligen should be approved, only because this is America, and folks should be free to put in their bodies what they wish. But if people choose to take it, it should be on their dime because it is unproven, and the costs are horrendous.

    BG-12 results were publicized.
    http://www.nytimes.com/2012/09/20/h...-suppressing-multiple-sclerosis-relapses.html

  7. satoshikasumi

    satoshikasumi Senior Member

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    Ampligen is the only thing that objectively improved my cognitive function, exercise performance, natural killer cell function, and Rnase-L.

    It will be a grave, grave loss to people like me if it is not approved because, as Cort points out, there is simply nothing else out there that is even possibly going to get approved in the next five years.

    Ampligen has been shown to work as a toll-like-receptor 3 agonist, and this research was published in a peer-reviewed journal.

    BG-12 has never had a clinical trial in ME/CFS, blinded or unblinded. It is worth further study, but many things that work for other neuroimmune diseases don't work for this one. Thirty years of bitter trial and error by patients has shown that!
  8. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

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    Wow, really interesting. Pls keep us up to date with BG-12. I hadn't heard of it.
  9. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

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    Excellent points. Ampligen approval would be the best thing that's ever happened to us, IMO. Everyone, please, please write in. I wrote in and got. My folks to also and sent out a request to some p w ME I know.
    Sasha and SpecialK82 like this.
  10. Marco

    Marco Old blackguard

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    Personally I'd also go for BG12.

    There's more evidence that I can see for ME/CFS being essentially a neuroinflammatory disease regardless of the trigger.
    MishMash likes this.
  11. Sasha

    Sasha Fine, thank you

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    Bumping...
  12. satoshikasumi

    satoshikasumi Senior Member

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    "In the End, we will remember not the words of our enemies, but the silence of our friends." Martin Luther King, Jr.
  13. Sasha

    Sasha Fine, thank you

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    That sent a shiver down my spine!

    Last day, everybody - go, go, go!

    Such an easy thing to do, such huge benefits for us all!
  14. Sasha

    Sasha Fine, thank you

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    Bumping - if you haven't written yet, please, please do it now!
  15. snowathlete

    snowathlete

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    I agree to a point MishMash.
    Ampligen does help some people, though probably it isn't the ultimate treatment that the majority of us will benefit from.
    BG-12 might be better than Ampligen, and we should shout to get BG12. BUT that isn't on offer at the moment as far as I am aware. Ampligen is, and I think any drug approved for ME/CFS will be a massive step forward, as the first recognized non-phycological treatment. It doesn't matter that it may not be the best drug treatment. The fact that it is expensive isn't all bad either as it would increase the desire to find a cheaper alternative, and that might actually help drugs like BG-12 get approved.

    If BG-12 is on the eve of possible approval in a year or two, but there is a better treatment not far away, we should still shout about BG-12 too, even though chances are, that it wont be the ultimate treatment for the benefit of the majority either.

    So, I totally think it is sensible to shout for Ampligen to be aproved, even if you are not a big fan. We would be mad not to really.
    Sasha likes this.
  16. MishMash

    MishMash *****

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    BG-12 will be ready to be prescribed in January 2013. It's here. There won't be any waiting. The only hassle will be finding a doctor to give it to you off label. The drug has been used for over a hundred years, and it is extremely safe. I'm hoping one of our CFS advocate docs will step in and fill this gap. For once, I could go to one of these docs and come home with something else besides supplements and kind words.

    If Ampligen is approved, through our letter writing campaign, it will probably take a year or more to make its way through the red tape at FDA. Who knows when you'll get it. Plus going to which treatment centers? It could be several years. All patients should study all drugs and weigh their options. Choose wisely which ones are most compelling.
  17. OverTheHills

    OverTheHills

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    One from New Zealand.
    Sasha likes this.
  18. Sasha

    Sasha Fine, thank you

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    Hi MishMash - I think that off-label issue will be a gigantic sticking point for most patients.

    Like snowathlete says, getting Ampligen approved is our ticket to a whole new world of legitimacy, research money, other drugs being approved.

    Let's by all means talk about BG-12 later - maybe start a fresh thread for it - but Ampligen isn't competing with it. It would be opening the way for it.
    snowathlete likes this.
  19. Sushi

    Sushi Moderator and Senior Member Albuquerque

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    MishMash

    We aren't discussing here the best drug to treat ME/CFS, we are advocating to get the first drug that is "on-label" for ME/CFS approved. This will pave the way for other drugs too.

    Sushi

    P.S. cross posted with Sasha
    snowathlete and Sasha like this.
  20. urbantravels

    urbantravels disjecta membra

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    This is certainly not a zero-sum game. In fact, it's a rising tide with the potential to lift all boats. Well, the seaworthy ones anyway. :) It's absurd to suggest that the approval of one drug would somehow stand in the way of approval of another drug. Each drug stands or falls on its own merits.

    And we have a complicated disease that almost certainly has different subgroups; it's pretty much a guarantee that there will never be one drug equally good for everybody. In fact, I don't think there are ANY diseases for which this is true. Even fairly sucky medications, which have been mostly replaced by newer and better medications, often stay on the market because there are still some situations where the sucky medication is the best option. You need as many tools in the toolbag as possible.

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