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Bob Miller on hunger strike: support him by emailing FDA about Ampligen - decision imminent

Discussion in 'Action Alerts and Advocacy' started by Sasha, Jan 31, 2013.

  1. Sasha

    Sasha Fine, thank you

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    Bob posted the message below on Cort's Health Rising site. It's a link to a Reno TV news station who did an item on his hunger strike.

    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
     
    BEG and Kati like this.
  2. Dreambirdie

    Dreambirdie work in progress

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    Bob posted this on Facebook today:

    "Patients who are able can call NBC News at 212-664-4444 and comment on the story below. Be sure to tell the person who answers why you are calling, they will put you through to a comment line where you can request for them to plesae cover this important News story Nationally, be sure to tell them where you are calling from.

    Many thanks to All who are helping, my wife and I could not do this without your help and support.

    Kindly,
    Bob"



    THIS IS THE STORY he is referring to: http://www.nbcnews.com/id/50666787
     
  3. Sasha

    Sasha Fine, thank you

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    Great stuff and I think this needs a new thread so people can see there's a new action required. I'll start one!

    Meanwhile, get phoning, US folks!

    Thanks, Dreambirdie!
     
  4. Dreambirdie

    Dreambirdie work in progress

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    Please do so, Sasha. Good idea.
     
  5. Apollonia

    Apollonia

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    I am not going to support this action. There is no good evidence that Ampligen is effective: that it is safe is only half of what the FDA has to ascertain. Ampligen has been on the ME radar since one year before I fell ill with ME; it's been talked and talked about ever since then; and it still isn't clear whether it helps. In fact, I'd say it is rather a drug in search of an illness.
     
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  6. Kati

    Kati Patient in training

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    @Appolonia, it may not be your cup of tea, but others have been helped by it and approval of Ampligen legetimizes our illness instead of getting fed the CBT-GET crap, days in and days out.

    If ampligen gets approved, it opens the doorto more reserch and drug development, and advances in the science of our disease.

    In the end, your choice. as for me, I am totally fed up with being sick and marginalized because my disease is not recognized.
     
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  7. Sasha

    Sasha Fine, thank you

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    Hi Apollonia - Rather than the clinical trial data, I've been more impressed by the testimony of the many long-term, very sick patients, including doctors, who have responded very strongly to Ampligen and of the clinicians who have had many years of using Ampligen and have seen patients do well on it.

    Normally we'd want clinical trials to be showing efficacy but it's clear that Ampligen doesn't work for everyone and without identifying the subset it works for, it would need a very large trial to show efficacy and we haven't had that yet.

    Cort has done some good pieces on the effectiveness of Ampligen on his blog, such as this one (there are more if you go to his home page and look through recent articles:

    http://www.cortjohnson.org/blog/201...-effort-to-approve-ampligen-hitting-the-news/
     
  8. Apollonia

    Apollonia

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    "Rather than the clinical trial data, I've been more impressed by the testimony of the many long-term, very sick patients, including doctors, who have responded very strongly to Ampligen and of the clinicians who have had many years of using Ampligen and have seen patients do well on it."

    With respect, and as I am sure you are perfectly well aware, the plural of 'testimony' is not 'evidence'. What individuals have to say, whether doctors or patients, about open-label use, without controls of any kind, of any medication, is not the sort of thing by which the FDA will be, or is supposed to be, persuaded. It is always worth remembering that the US supplement industry, aided by its bought-and-paid for shill in the Senate Orrin Hatch, spent $2.5 bn (in 1994 money) to make sure that the FDA could, by law, assess only the safety, not the effectiveness, of vitamins etc.

    "Normally we'd want clinical trials to be showing efficacy but it's clear that Ampligen doesn't work for everyone and without identifying the subset it works for, it would need a very large trial to show efficacy and we haven't had that yet."

    I do not see why Ampligen should be treated differently from any other drug that would 'normally' be subjected to at least one more large clinical trial. If it is indeed effective only for a subgroup of ME patients, then, obviously, members of the other subgroup who tried it would be spending their money, or someone else's money (and it's a lot of money), to no purpose whatsoever, except to enrich Hemispherx shareholders. Hemispherx know that ME sufferers are desperate, and that many of us will try anything, if told it has helped someone else with ME. I do not want to see any ME sufferer become the sucker who gets taken for (say) $15K p.a. for the foreseeable future.

    You may perhaps reply that that is their choice: but the FDA is legally barred from choosing to allow US citizens 'try anything' provided it's safe, where that thing is marketed as a medication and not as a supplement.

    "Cort has done some good pieces on the effectiveness of Ampligen on his blog, such as this one (there are more if you go to his home page and look through recent articles:"

    http://www.cortjohnson.org/blog/201...-effort-to-approve-ampligen-hitting-the-news/[/quote]

    I would say that the key datum in all that material is this: that the 2012 paper, summarising the 2004 trial, was composed by doctors most of whom had a financial interest, one way or another, in the success of Ampligen. Why doesn't Hemispherx sell Ampligen as a supplement? Because it's so expensive only medical insurance would cover it.

    best wishes
    Apollonia
     
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  9. Apollonia

    Apollonia

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    "Appolonia, it may not be your cup of tea, but others have been helped by it and approval of Ampligen legetimizes our illness instead of getting fed the CBT-GET crap, days in and days out.

    "If ampligen gets approved, it opens the doorto more reserch and drug development, and advances in the science of our disease."

    Not necessarily. If Ampligen is approved, but if it is then found that after all it does not work; or that it works, but helps only a small subset of sufferers to a small degree; and/or that it helps with some randomly distributed range of symptoms (e.g. greater physical resilience but no cognitive improvement in me, the opposite in you); and/or its aitiology continues to remain as obscure as it is today (another reason I am suspicious of it), there will be no good reason to hope for changes in the attitude to ME of the wider medical community—an attitude that it is already abundantly clear is a combination of arrogance and ignorance of the many scientific papers that have found physiological abnormalities in ME patients.

    What's more, our "image" has already been damaged by the XMRV fiasco and by what was, I'm afraid, often an irrational response from ME sufferers to the original studies. It encouraged some people to look on us even more as headcases. Which, in a way, we are (for one thing, the hypothalamus is in the head)—but not in the way they mean it.

    "In the end, your choice. as for me, I am totally fed up with being sick and marginalized because my disease is not recognized."

    So am I. I agree with you on the last point as only a fellow ME sufferer can. But what is not a matter of choice is for the FDA to approve a medication the efficacy of which has not yet been proven. Safety is a necessary but not a sufficient condition for FDA approval. If it were, Ampligen would be being marketed as a supplement, not a drug.

    with best wishes
    Apollonia
     
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  10. Kati

    Kati Patient in training

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    Cancer drugs are expensive. And they don't necessarily work. Take cancers like melanoma, or pancreatic or one particularily agressive form of lymphoma called Burkitt's lymphoma, or T-cell lymphomas- the odds of patients dying arepretty high. Yet, these patients all think that the drugs they are being offered are worthwhile.

    In my country (Canada ) where health care is universal, cancer patients are being given a chance at first, second, 3rd, etc line of treatments. It doesn't cost patients extra. If they chose so, they would even get experimental treatment when there is knowledge that no chemo will stop their cancers, and patients take that chance. The cost to society is measured in hundreds of thousands per pt.

    In our case, this Ampligen treatment is about being given a chance. It's an opportunity for everyone willing to, and able to, to get treatments. As for the cost for my american friends, I am sorry that not everybody can afford it- it's a travesty. However the problem is bigger than Ampligen, it's a societal values problem. And let's not shoot ourselves in the foot by saying that only the rich ones can afford it. It is my hope that Obamacare will help with reducing disparities in health care however this does not solve the disparities in between diseases especially with our disease.

    Back to my cancer analogy, there will be some patients diagnosed with cancer that will say no to medical treatment, trying their luck with alternative treatments. Their choice.

    I want to have the choice of medical treatment. It starts by approving Ampligen, knowing it is safe for human administration. Give Hemispherx a chance at developping the drug, and figuring out which subset is likely to respond. We have success stories already. To me, it shows hope.

    ETA: And then what do you say to the people who are surviving, are able to walk or can manage to interact with their families because of Ampligen, if FDA is not approving the treatment? Sorry, we don't want you to have it? Go back to CBT and GET?
     
  11. BEG

    BEG Senior Member

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    Kati, with just a little reworking, this would make a great email. Even though you are Canadian, it speaks very well to the FDA.
     
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  12. Ember

    Ember Senior Member

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    On December 5, Kim McKleary commented:
    Does anyone know what CFS definition Hemispherx used in seeking approval for Ampligen?
     
  13. Ember

    Ember Senior Member

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    According to Cort, Hemispherx recently re-analyzed its data using patients with lower disease duration (1-10 years). If this is their only proposed subset, then Bob Miller would be denied Ampligen as an unhappy consequence.
     
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  14. Firestormm

    Firestormm Guest

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    Don't know what happened to the font.
     
  15. taniaaust1

    taniaaust1 Senior Member

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    Sighs.. the above quote is exactly why they should of changed the terrible name.. people always go thinking this illness is just about fatigue.
     
  16. taniaaust1

    taniaaust1 Senior Member

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    NO DRUG is ever likely to show good efficiently due to the mixed nature of those who have CFS.

    Hence why any drug which is working well for a group of us.. should be approved if deemed safe enough for those on a risk verses benefit basis.
     
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  17. Kati

    Kati Patient in training

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    taniaaust1, no therapy is entirely successful across all diseases. Take cancer, rheumatoid arthritis, lupus, schizophrenia. Some of these diseases are very well defined, but in no way everybody responds to therapy. That's just how it goes.

    For our patient population, we are facing the fact that our disease is difficult to diagnose objectively, of course we lack biomarkers, and likely there are subsets wihin our disease. I really wish these subsets could be discussed more openly by our experts, but this has, in my opinion to be backed up by science and we are not there yet.
     
  18. Ember

    Ember Senior Member

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    Here's an open discussion of the ME subset by our experts:
    Speaking for the FDA, Dr. Sandra Kweder pointed out at the October CFSAC meeting, “There are no biomarkers for migraines and we approve drugs to treat migraines all the time.... It’s great if there is one, but it isn’t in and of itself essential.”

    Again according to Dr. Kweder:
     

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