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Action alert: Bob Miller calls for email campaign to request hearing on Ampligen

Discussion in 'Action Alerts and Advocacy' started by Sasha, Mar 6, 2015.

  1. Sasha

    Sasha Fine, thank you

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    As we all know, the IOM and P2P reports, and the Hornig/Lipkin cytokine paper, give us weapons with which to press for funding, treatment, and respect for our long-neglected disease.

    On Health Rising, Bob Miller has made the first call to action off the back of these important events. He's calling for mass action to pressure the government on Ampligen. This is an advocacy action that has been in the pipeline for a while and is now ready to go.

    Bob says that another advocacy campaign - to pressure the NIH for more research funding off the back of these important events - will begin soon.

    Here are details of how to take part in the Ampligen campaign. I've impertinently given Bob's instructions a light edit and have broken up the text for ease of reading.

     
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  2. Sasha

    Sasha Fine, thank you

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    Bump...
     
  3. Sasha

    Sasha Fine, thank you

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    Bump...
     
  4. Jonathan Edwards

    Jonathan Edwards "Gibberish"

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    Dear Sasha,
    This is an interesting proposal. Let me be devil's advocate, though.

    One complaint is that the FDA admitted it did not fully understand this disease. So that makes quite a few of us - is this really a helpful introduction - seems not to me.

    The proposer says that approval would bring 'insurance coverage for all'. I found a blog that said that the cost of ampligen at their clinic was $2000 per month. So if a million Americans took ampligen that would cost $24 billion straight off. Is this the best way to spend the notional cost (almost to the penny) of ME? There would be nothing left for research.

    It seems that ampligen is fairly safe but what I am unclear about is convincing evidence of efficacy. For me that would be clinched by a double blind RCT of at least three doses so that we knew we had roughly the right dose, rather than maybe four times the right dose or a quarter the right dose. That is basic testing if you are thinking cost-effectiveness. Do we have anything of that sort?

    If we do not have anything of that sort then maybe what PWME should be pressing for is not a reimbursement cheque for $24 billion but a government run trial of the sort above, which ought to cost about $2.4 million - one ten thousandth of the cost of approval without proper testing.

    The problem we have in the UK is that the government simply does not see it as its job to test drugs owned by commercial interests. NICE is not interested in whether a drug works, only in whether a company has shown convincingly that it does. This was a big problem for RA treatments. If ampligen is coming out of patent maybe things could be easier. And if so maybe what PWME should be petitioning for is a decent trial of ampligen rather than spending ten thousand times as much money on something that might not work after all or which might work at a quarter the recommended dose.

    Edit: actually over ten years it would be a hundred thousand times as much - isn't this bonkers?
     
    Last edited: Mar 7, 2015
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  5. A.B.

    A.B. Senior Member

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    Isn't the point of Ampligen to increase NK cell function? Aren't there cheaper alternatives to do a proper trial with? Nancy Klimas mentioned Immunovir.
     
  6. Sasha

    Sasha Fine, thank you

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    Only too happy for devil's advocates to discuss this whole issue, @Jonathan Edwards!

    There's quite a history to this Ampligen question, which is not included in Bob's article, but my understanding is that the US govt is legally prevented from running a trial because of Ampligen's legal status (can't remember the issue) and its parent company, Hemispherx, can't afford to trial it further than it already has.
     
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  7. Jonathan Edwards

    Jonathan Edwards "Gibberish"

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    I guess that shows just how dumb capitalism is?
     
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  8. Kati

    Kati Patient in training

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    On one side we have many patients who say that Ampligen works for them and should they be refused access to it they would be confined to their house or their bed.

    And on the other hand we have the FDA which has a responsibility to the public for safety of drugs one the market. Safety in this case was not deemed the problem. Efficacy was the problem, due to the the fact that it is difficult to have end points.

    The problem that many patients find is the double standard that FDA seems to have, when riskier drugs for other diseases are approved and fast-tracked but Ampligen has been stuck in phase 3 for 2 long decades.

    Patients need and deserve a few lines of treatments. We know that it would be really rare that a drug is 100% effective on everyone. However if 25% of us respond to Ampligen and another 25% to Rituximab and 50% to Valcyte or other antivirals, we then already have 3 options for treatments. Giving patient hope in an era where many have given up and taken their own lives should be made a priority.
     
    Last edited: Mar 7, 2015
  9. Jonathan Edwards

    Jonathan Edwards "Gibberish"

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    If people think ampligen helps I suspect that is a more useful starting point than any theory about why it might work. Lots of drugs that work turn out to work for unexpected reasons. If the idea is that ampligen ought to be available if it works then $2 million would probably be justified.
     
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  10. Kati

    Kati Patient in training

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    i think one of the reasons why Dr Peterson is so successful with Ampligen is because he handpicks his patients, on what criterias I don't know.
     
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  11. Sasha

    Sasha Fine, thank you

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    Yup.
     
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  12. heapsreal

    heapsreal iherb 10% discount code OPA989,

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    Socialism just locks people with ME up in psych wards.

    I wish they would bring out some new forms of ampligen so theres alternatives to regular infusions etc
     
    Last edited: Mar 7, 2015
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  13. *GG*

    *GG* Senior Member

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    America is not a Capitalist society, far from it, and it has been this way for a long time!

    More like Crapitalism, look it up!

    GG
     
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  14. oceiv

    oceiv Senior Member

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    I agree with @Kati's assessment of the Ampligen situation. In addition IMHO, if this medication has helped 25% of ME/CFS patients, it should be made available. There was a recent study on Ampligen. It gives some updated info on Ampligen. The FDA is slow-walking Ampligen because it and other agencies still don't believe this disease is real, not because of efficacy or safety.


    @Jonathan Edwards It is bonkers. The cost calculations for what Ampligen coverage would cost the U.S. government are different than calculations for a country with universal, government-provided healthcare. Most U.S. citizens who have medical insurance get their insurance from private, non-governmental insurance companies. These private insurers are allowed to negotiate for better prices for their customers on any given medication, treatment, doctor service or procedure. Therefore, an MRI, for example, can cost anywhere from under $1000 to thousands of dollars depending on your insurer. The same type of wide price variations exists with medications. Depending on how good a person's coverage is, the insured person could have to pay none, some or all of that negotiated price.

    Unfortunately, by law, the government can't negotiate prices on any medications. The drug lobbies have been very successful in protecting their high profits. Many medications cost more for the government than they do for private insurers. I don't know the percentages on how many ME/CFS patients are insured vs. uninsured. But for the uninsured patients, the Ampligen costs would be born solely by the patients, not the government. Many other Americans are underinsured (often in what's called "catastrophic coverage plans."). These people would probably also bear the whole Ampligen cost. More on U.S. health insurance coverage.

    But, even though the U.S. government would not bear all of the Ampligen costs were it to be approved, the U.S. government would bear many of the costs of patients who would be well on Ampligen, but are completely disabled without it. From loss in tax revenue to loss from SSA disability to medicare and medicaid costs.
     
    Last edited: Mar 7, 2015
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  15. oceiv

    oceiv Senior Member

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    Is there a way to get more info on The FDA Action Team and/or to contact them?
     
  16. Jonathan Edwards

    Jonathan Edwards "Gibberish"

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    Dear Kati,
    I agree that giving people hope is crucial but I have yet to be convinced that the FDA is applying double standards. I am quite convinced that ME has a biological basis and needs higher priority so by being 'devil's advocate' I guess I am saying that if you want to convince the FDA then try to convince me first, because it should be easier.

    The role of a medical control agency like FDA is presumably more complicated than just safety. I do not know their charter but I suspect that part of their role is to adjudicate on whether or not claims of efficacy are reasonable. I see that as a bit like the old Trade Descriptions Act which says that you cannot sell something and claim it does something unless you can show that it does. It is easy to get your money back on a microwave oven that does not cook but health care is more complex - you may not have the chance to go back and try the thing that did actually work - so most countries have a system for evaluating claims of efficacy.

    And as far as I can see this is in practice what this is about. People can get ampligen but approval from the FDA would change things in terms of reimbursement from insurance companies. Insurance companies get their money from ordinary people so effectively the FDA is saying 'We are not convinced that every man woman and child in the USA should pay another $100 on their health insurance so that people can get free ampligen because it may not work. If we approved drugs like this without good evidence of efficacy then the same would apply for another nine common diseases and everyone's bill would go up $1000.)

    I agree that the US health insurance system is different from that in the UK but it is largely a matter of how it is administered. It is ordinary people that pay - in the UK into a state run insurance system. Politicians get voted in or out according to whether they manage health insurance sensibly - whether in terms of value for money for tax or what you have to pay to get private health insurance.

    So the bottom line is that approval means that the ordinary US citizen should foot the bill. Would PWME be happy to pay another $900 a year for drugs for the other nine common diseases that might not work?

    I had a close look at the study the ampligen people quote a while back. My impression was that the results are presented in a form that is hard to interpret. They say there is a 21% improvement in activity but the bare figures suggest it is 10% and that does not seem very much. To my mind this sort of average figure is not what is wanted. We want some sort of figure indicating how many people were usefully better in each group - a bit like the Haukeland study. I fully appreciate the problem of outcome assessment for trials but if a study is properly blinded I think there are ways of assessing useful improvement that ought to stand up.

    So I would go with the FDA at present. And I would come back to the point that there should be a minimum dose (dose response) assessment. Otherwise people may be paying for four times as much drug as in needed. We actually have that problem for rituximab because nobody insisted on a minimum dose assessment. Work on a similar drug suggests that minimum effective dose may be somewhere between 100 and 1000 mg per infusion but we may well be spending twice as much on rituximab as is needed (as someone flagged up in a study somewhere else).

    The real problem seems to be the crazy rules designed to protect private commercial interests. I personally do not think there should be such things as patents in health care products. When you see the money wasted on company premises and parties in Hawaii it makes you weep.
     
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  17. Sasha

    Sasha Fine, thank you

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    Hi oceiv - Bob Miller has a Facebook page:

    https://www.facebook.com/HungerStrikeForAmpligen

    The title refers to the fact that he went on hunger strike at one point to put pressure on the FDA to approve Ampligen - a very distressing thing to see...

    Cort Johnson may be able to put you in more direct touch with him, and you can contact Cort via Health Rising:

    http://www.cortjohnson.org/contact-us/
     
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  18. Sasha

    Sasha Fine, thank you

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    Once again, thanks for engaging in this kind of discussion! We need these things thought through critically.

    That's just it - my understanding is that people can't get Ampligen unless they're in some weird scheme. Bob Miller was getting it because his doctor was in that special scheme with Hemisperx - he had to move himself and his whole family so he could be near to that doctor to get the infusions administered. I'm not sure if that scheme was stopped - if my memory serves, the clinicians were getting Ampligen under some special arrangement to do with research. I wonder if it was to provide safety data or something.

    Bob (and Cort, I think) claim that the FDA is approving drugs with a similar safety/efficacy state of evidence as Ampligen for other conditions; there certainly seems to be a lot of weirdness about how the FDA do things and my understanding is that the FDA is seen by many in the US as being in the pharma industry's pocket.

    I'm not sure about your cost calculations on this. An estimated 90% of US PWME don't have a diagnosis, so we're only talking about 100,000 patients at this point (though that could change if the IoM recommendations are rolled out); not all doctors are going to prescribe it; and it may become apparent quite quickly what subset of patients benefit. So the real figure could be more like $50/year maximum; and one would hope that some patients would do so well on Ampligen that they wouldn't need to stay on it.

    In terms of whether I'd be happy to pay $X (whatever X is) for drugs of questionable efficacy for other common conditions, I think that would depend on whether those conditions already have any kind of treatment available: ours doesn't.

    People were disappointed, I think, at the time about how Hemispherx presented their data. If they presented it the way you've been suggesting (scatterplots of individual patient data) that would be useful.

    I think I'm sounding like some sort of major apologist for this campaign because I posted it and then bumped it so that the Ampligen afficionadoes here on PR would be aware of the campaign. But I'm aware that the data as presented by Hemispherx aren't as strong as they might be and I agree that in a sensible world, the next thing to happen should be further, high-quality trialling of Ampligen and the dose-assessment that you're suggesting.

    But that doesn't seem to be an option: the US govt agencies are legally barred from trialling Ampligen (as I understand it) and Hemispherx are too small a company to be able to afford to do it (article on that here by Cort - who is very pro-Ampligen).

    That leaves people like Bob Miller with only one option, it seems to me: to campaign for the FDA to approve Ampligen as is.

    If you were Bob, what would you do?

    How else can he move the Ampligen issue forward?
     
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  19. Jonathan Edwards

    Jonathan Edwards "Gibberish"

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    I take that point. But my understanding is that several thousand doses have been given - so quite a lot of people have got it. So there is another possible argument - that people should be able to buy ampligen treatment if they can afford it. But how many PWME can afford $24,000 p.a. indefinitely? And should they if we do not know it works - or even that a quarter dose might be as good?

    I entirely agree that the FDA and the UK MCA and NICE make some very dodgy decisions. PWME have grounds for protest - but it is best to protest on sound grounds. I have spent thirty years developing drugs that work well and drugs that people would like to work well but don;t do much. From what I see ampligen looks rather like a 'don't do much' to me. I would like to be proved wrong but we want evidence. And the FDA is not in the pharma industry's pocket - it IS the pharma industry's pocket - the one with the wallet in, accessed by 'revolving zippers'.

    My cost calculations are suspect, I agree. But they may not be unrealistic. You cannot argue that the undiagnosed people do not deserve ampligen - so I think that won't wash. Of course not everyone with ME would go on ampligen. However, the general point is that if you approve ampligen you have to approve anything similar that comes along that has not really been tested properly. In RA there are now at least six drugs that cost thousands of dollars a year. If you do not have one you can have another. Health insurance for RA is probably now costing everyone in the UK £50 per annum.

    I am not sure that 'any kind of treatment available' is really what matters. There are treatments for MS but the reality is that they do not solve the problem. People with MS are just as stuck as PWME.

    Then maybe the campaign should be to make laws on testing drugs more in the interest of the consumers and less in the interest of venture capital people. It seems to me the people who at fault here are to some extent the American public who have voted for politicians who think the current laws are ethical. I don't buy the bit about Hemispherx being too small. When I have come across situations like this before with drugs in the pipeline, if the data in house look promising to independent scientific advisors like me then the company usually has trouble fighting off the overtures from big companies to buy them out. The people in the small company sell out and live the life of Riley.

    I don't think the FDA is going to respond - it would be opening the floodgates to hundreds of billions of increase in insurance premiums. I think the law needs changing. Governments support vaccine programs - I bet the law as it stands could be interpreted so that a trial could be done. I think it is the NIH that needs lobbying.
     
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  20. Sasha

    Sasha Fine, thank you

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    I think you're making a lot of good points there, @Jonathan Edwards, and I don't think I've got any particularly good answers. I wish Bob Miller would come to PR and discuss his campaign rationale but this doesn't seem to be his environment.

    Interesting point about Hemispherx. I just don't know enough about the history there.

    I don't understand the US system well enough to know whether it's the NIH that needs targeting, exactly what we should ask for from them, or how well they're likely to respond to a bunch of PWME. We've had zero success for years in getting increased funding from them.

    But if there's a better campaign there, perhaps we should be thinking about it.

    It's at this kind of point that I hit a bit of a brick wall, I must admit. There are clearly issues to be discussed if it's the NIH that should be targeted, but this is a US problem and needs US advocates to take the lead on first having a discussion, and then leading a campaign on it.
     
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