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URGENT: Email the FDA about Ampligen now and daily – final decision is imminent

Discussion in 'Phoenix Rising Articles' started by Phoenix Rising Team, Jan 6, 2013.

  1. Sasha

    Sasha Fine, thank you

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    Hi dannybex - the action we've been asked to do by Bob Miller, Cort and team is to send daily emails. I'm assuming the rationale is that a barrage of constant pressure will be more likely to change minds.

    Imagine that you're one of these officials and that two weeks ago, you got several hundred emails on this topic and then they stopped. You haven't heard anything else from people for weeks and it's slipped down your agenda as other stuff has come across your desk.

    Now imagine that every morning for the last two weeks your inbox has been flooded with hundreds of emails on this topic. You can't get away from it. You can see how desperate people are for Ampligen, they're emailing you every day.

    Which scenario would make you more likely to take action?

    I don't understand what you mean about 'those marked "anonymous" with no message'. The action is to send an email (which automatically has the sender's name, even if they forget to add it) and to copy and paste the message that Bob and team have prepared, if you don't want to create your own.
  2. Sasha

    Sasha Fine, thank you

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    Just done today's...

    Have racked up quite the collection of autoreplies from Kathleen Sibelius :)
  3. dannybex

    dannybex Senior Member

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    Sorry, I should've clarified -- I had seen the petition on the other thread (started by Freds?) -- that's what I was referring to. There were several repeated names and quite a few anonymous "signatures".

    The copy and paste technique for the emails does make it a lot easier for us to send messages -- not sure how effective that is -- but I guess we'll find out about 10 days or so?

    Thanks Sasha.

    d.
  4. Sasha

    Sasha Fine, thank you

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    Sorry, I should have guessed you were talking about the petition! If names are just repeated I'm assuming they won't be counted. As for the anonymous ones, those people will have given their name but ticked the box that allowed their name to be hidden on the website.

    Yep, not long now to the decision so let's keep that email deluge up! With any of these actions, it's hard to know how effective we're being but the one guarantee is that doing nothing is the worst possible option. That email is a one-minute action - absolutely no reason not to email.
  5. Sasha

    Sasha Fine, thank you

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    Just done today's email, looking forward to Kathleen Sibelius's autoreply :)
  6. Sasha

    Sasha Fine, thank you

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    Just done today's email.

    Maybe a week or so til the decision - could come any time, let's keep emailing...
  7. Sasha

    Sasha Fine, thank you

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    I've just done today's email using this excellent piece, issued by Dr Nancy Klimas, as the text of my message (discussion of her piece is on another thread):

    Ampligen, the first drug ever seeking approval to treat chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), recently hit another roadblock with the U.S. Food and Drug Administration (FDA).

    In its long quest to treat 1 million Americans suffering from this debilitating illness, the FDA advisory panel did not recommend the drug to be sold on the market, largely because CFS/ME doesn't have clear biomarkers such as blood tests to define patients who most likely to respond to the drug. Data from clinical trials of Ampligen has not convinced the FDA so far.

    The real loser is not Ampligen, but CFS/ME patients whose daily suffering continues to be unabated. CFS/ME feels like you've been run over by a truck - pain, inflammation, utter exhaustion and trouble concentrating.

    I have been caring for patients with CFS/ME for 26 years now. It's heartbreaking seeing them struggle and suffer from this serious illness that has been trivialized by science and society. One of the early controversies quickly disproven suggested that CFS/ME is a form of depression. This led to enduring public policies that allowed insurance companies to limit coverage to CFS/ME to either mental health or exercise therapy, neither get to the root cause of CFS/ME.

    CFS/ME researchers, including myself, have seen major advances in our understanding of the biology of CFS/ME. It seems to resemble an illness we know how to treat like multiple sclerosis (MS), chronic viral diseases and autoimmune diseases.

    Around since the late 1980s, this drug is not new to science and medicine. Two phase 3 clinical studies have been completed. The data shows that a subgroup of CFS/ME patients showed marked improvement, even recovery on the drug.

    Yet, that's not enough evidence for the FDA advisory committee to approve because they would like to see a conclusive biomarker. As a physician, I could live with this decision if I had other effective therapies to treat my CFS/ME patients. But I do not. Moreover, it defies common logic in used in drug approval for other complex immune mediated diseases.

    Take for example, MS: Its earliest approved treatments had opposite immune effects. One interferon increased immune activity and a second interferon quieted immune activity. In the studies that led to approval, MS drugs, like Ampligen, had about a 40 percent success rate.

    Clinical research for these early MS drugs produced no biomarkers other than a patient's successful response to therapy, such as the case of Ampligen. The biomarker the FDA relied on for approval of MS --- seeing if the lesions in a patient's brain decreased -- had no correlation to the patient's improvement.

    Why would the FDA approve MS drugs before there were concrete biomarkers to determine success? The answer is simple. The advisory panel saw MS as a serious disease that required interventions ASAP, and were willing to accept that clinicians would better understand where to use the first drugs with more experience using them. Now there are seven approved drugs for MS that have significantly improved quality of life for patients. But they are not willing to use the same logic for Ampligen.

    Because CFS/ME patients are stilling waiting for their first therapeutic, Nova Southeastern University (NSU) in Fort Lauderdale, Fla. has brought on board a nationally renowned group of experts to form the NSU College of Osteopathic Medicine Institute for Neuro Immune Medicine, which will open in February.

    These doctors and scientists will conduct basic research using genomics to help further develop drugs to treat this disease, while they treat patients. They are also doing clinical testing for Ampligen.

    With or without a biomarker, the FDA should recognize the seriousness of CFS/ME and approve Ampligen, and open the door for other targeted therapies now.

    Nancy Klimas, M.D., one of the world's leading researchers and clinicians in chronic fatigue syndrome/myalgic encepahalomyelitis (CFS/ME), is the director of the Nova Southeastern University's College of Osteopathic Medicine Institute for Neuro Immune Medicine.
    Source: Nova Southeastern University
  8. Sasha

    Sasha Fine, thank you

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    Just sent today's email.

    The decision is expected around this weekend so let's keep the pressure on...
  9. Sasha

    Sasha Fine, thank you

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    Just done today's...
  10. Sasha

    Sasha Fine, thank you

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    Just done today's.

    Decision any day now. Fingers crossed! Let's keep emailing.
  11. Sasha

    Sasha Fine, thank you

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    Cort wrote a great email that he reproduced in the comments section of his blog that I'm using today for my own email (sorry about the formatting):

    http://www.cortjohnson.org/blog/201...-on-hunger-strike-ampligen-approval/#comments

    The FDA Advisory Board voted 8-5 that Ampligen was safe enough for conditional approval given the study data and 15 years of clinical data and the chronic fatigue syndrome communities needs. Disability rates are high in this condition and no drugs have been approved for it in its 20 years history and no other drugs for the disorder are under development.

    Advisory Committee members were clear that the drug was safe enough even if more study data was needed. They offered a clear path for conditional approval that would provide Hemispherx, a small drug company, the ability to fund further studies. Without conditional approval Ampligen will probably disappear and chronic fatigue syndrome patients will lose their best chance at a drug that helps them.

    The chronic fatigue syndrome community needs a chance at this drug. Approximately 4,000 patients have signed a petition stating so and over 750 provided written testimony to the FDA Advisory Board. So many patients watched the proceedings that they crashed the FDA’s servers.

    Longtime chronic fatigue patient Bob Miller is currently on a hunger strike to emphasize the need for Ampligen approval for this disorder.

    Please conditionally approve Ampligen for this community.
  12. Research 1st

    Research 1st

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    What will happen if Ampligen isn't approved?
  13. Sasha

    Sasha Fine, thank you

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    Hi Research 1st - as I wrote elsewhere:

    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.
  14. Research 1st

    Research 1st

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    Thanks Sasha. I must admit to thinking the same too and that we could get some respect from the medical community and that Ampligen would be a catalyst for being taken seriously.

    I was really pondering though what will happen if the FDA reject Ampligen, and specifically what will Robert Miller do?
    I hope he is prepared for a disappointing outcome. I remember watching his passionate speeches (CFSAC webcasts). He's a very determined individual and I hope he can cope with this if things don't go our way. Things haven't as of yet, ever gone our way.
  15. Sasha

    Sasha Fine, thank you

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    Sorry, I misunderstood you!

    I don't actually know and, like you, I'd like to know. On the TV report about Bob's hunger strike (link below) Bob and another patient on Ampligen are interviewed and I got the impression that their Ampligen might be withdrawn but I don't understand why.

    Here's the link, posted as a comment by Bob on Cort's blog:

    Here is the correct link, to a news story about FDA and Ampligen HungerStrike Day 4, scroll down the page a bit until you see me in a thumbnail photo and click on that Block # 1, it is the first story is up, also has Dr. Janet Smith with me.http://www.mynews4.com/content/asseenonnews4/news4at6/default.aspx
  16. caledonia

    caledonia

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    They keep adding new news segments to that page. You may have to scroll down the list to see the correct segment. Anyway, it's News 4 at 6 / 1-31-13 / Block 1.

    Does this mean you won't be able to get it in the US, or does it mean they stop manufacturing Ampligen altogether without this approval? It is approved in Canada and one other country (can't remember which one). So presumably you could go to Canada to get it, and they have sales there.
  17. dannybex

    dannybex Senior Member

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    I don't see why they would stop making it. It's been around for 30 years with no FDA approval...

    ???

    p.s. I read on another board that that it's unlikely the FDA will announce their decision, but that the news would come from Hemispherx, but I have no idea if that's true or not.

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