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FDA should give CFS patients access to Ampligen! --Online Petition

Discussion in 'Petitions' started by JohnnyD, Dec 27, 2012.

  1. JohnnyD

    JohnnyD Senior Member

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    http://www.ipetitions.com/petition/ampligen/

    Over a million US citizens are suffering from Chronic Fatigue Syndrome. It's a life-debilitating disease for which there is currently no approved cure or treatment.

    Ampligen has been undergoing trials for over two decades and has benefited a great number of patients to no end and without ill effect.

    We urge the FDA to conditionally approve Ampligen. There is no alternative.

    We ask the FDA to recognize our ability to make an informed decision. Please let CFS patients decide!
     
    Robert Dain, ukxmrv and Nielk like this.
  2. ggingues

    ggingues $10 gift code at iHerb GAS343 of $40

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    I think it would be as powerful to add that estimates are that there are up to 4 Million sufferers in the US, (17 Million worldwide).

    GG
     
    CallieAndToby likes this.
  3. BEG

    BEG Senior Member

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    And I wonder what % of patients will benefit? No ill effects? I was in Trial 516. I can tell you about ill effects. And it was confirmed, while I was attending a CFSAC meeting, by 2 ladies from Hemispherex who said to me, "we hear about this all the time,"

    The drug company must find the types of patients who will most likely benefit from Ampligen and also those who could possibly have an alarming allergic reaction.
     
    CallieAndToby and Firestormm like this.
  4. taniaaust1

    taniaaust1 Senior Member

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    I think any drug said to be safe.. certainly dont mean it is safe for all. Even something as innocent as strawberries or peanuts arent safe for all. ALL drugs can have side effects. With anything risk verses possible benefit needs to be weighed up by a case by case bases.

    Its its put onto the market even if only conditionally for the more severe patient group.. this will over time help with finding out exactly which subgroups it is best for.
     
    CallieAndToby likes this.
  5. taniaaust1

    taniaaust1 Senior Member

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    Im currently confused... can someone help clear up my confusion.

    above quote from the petition.

    the quote from a news article at the ME/CFS Australia (SA) website http://sacfs.asn.au/news/2012/12/12_23_panel_rejects_experimental_chronic_fatigue_syndrome_drug.htm.


    I dont understand the conflicting info on its safety? Did the FDA say their was inadequate evidence of safety while at same time say it was safe??
     
  6. LaurelW

    LaurelW Senior Member

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    I was there, and I'm confused as you are. They had the committee answer two questions that were almost exactly the same--one was voted majority no, and the other majority yes. I wish someone would enlighten me!
     
  7. Freds

    Freds

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    Hi there. I'm the one who started the petition. In response to LaurelW's question above, here are the two confusing votes in question. I added the square brackets in an attempt to best explain their difference as I understood it.

    "Has the safety of Ampligen [as implied by these particular Hemispherx trials before us] been adequately assessed and characterized for the treatment of chronic fatigue syndrome (CFS)?"

    Yes: 4 (Marshall, Perry, Rudorfer, Perry)
    No: 9
    Not Voting: 1

    "Is the safety profile of Ampligen [as implied by the totality of studies and data] adequate for approval for the treatment of CFS?"

    Yes: 8 (Borish, Gardner, Hennessy, Marshall, Perry, Rudorfer, Russel, Unger)
    No: 5
    Not Voting: 1



    In a nutshell, I believe the Committee expected an encompassing trial and sought to display its disapproval of some of the statistics at the expense of a patient's right to choose.
     
    taniaaust1 and BEG like this.
  8. JohnnyD

    JohnnyD Senior Member

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    Hi Freds, any possibility to modify your great petition to incorporate the above suggestion and make it a more powerful statement? Something along these lines?

    URGENT: Medical Crisis
    An estimated 4 million US citizens are suffering from Chronic Fatigue Syndrome or CFS/ME [CDC, CFIDS]. 20 Million people Worldwide. CFS/ME is a serious and life threatening illness that is as debilitating as MS, Lupus, COPD, End stage renal disease and other severe chronic diseases [CDC], for which there is currently no approved treatment.

    Rintatolimod (Ampligen) has been undergoing FDA trials for over two decades and has benefited a great number of patients to no end and without ill effect.

    A drug company should be encouraged by FDA to pinpoint the particular subset or subsets of people who respond well to a drug, not discouraged. 20 years, one drug by one company.

    Even those who do experience some of the reported minimal side-effects may very well prefer them over the unbridled disease with its devastating comorbidities. The FDA should not try to make these decisions for patients with a safe drug. There is no alternative treatment and nothing coming soon as no other drug company will sponsor an FDA trial until Ampligen is approved!

    As CFS/ME Patients and Loved Ones:

    § We urge FDA to recognize patients’ input on December 20th, 2012, that Ampligen is safe, effective and a true option

    § We urge FDA to approve Ampligen in recognition that there is a crisis-level of unmet medical need in treatments for CFS/ME

    § We urge FDA to follow Commissioner Hamburg’s request from Dec. 5th “to go beyond the statistics, you’ll find the reality”

    § We urge FDA to follow President Obama’s request to elevate the priority of CFS

    § We urge FDA to recognize patients’ ability to make an informed decision to choose Ampligen under doctors care


    § We urge FDA to approve Ampligen by February 2nd, 2013, the sponsor agreed to a REMS program on December 20th, 2012


    Please show your support by signing this petition. Share it with your friends and let the FDA know they too should hear us loud and clear: Let CFS patients decide!
     
    Lcasey67 and ggingues like this.
  9. dannybex

    dannybex Senior Member

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    Johnny -- both the trials and patients testified that there were indeed 'ill effects', so I think you'd have to change that so that it will be taken more seriously.

    Plus, I would modify 'no approved treatment' to say something more like 'no FDA approved drug treatments', as there are plenty of other non-drug 'treatments' and protocols that may help and are helping some patients. It's not as black and white as the description in the petition.

    Just my two cents.
     
    ggingues and taniaaust1 like this.
  10. Freds

    Freds

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    Hey that's great JohnnyD, I'd be happy to -- give me an hour or so, dinner's ready.

    Dannybex, thanks for the input, I'll include your "drug treatment" term. As for the ill effects, I do hope the text is clear later on there certainly are many patients experiencing side-effects. But afaik there are also a great deal who experience no ill effects at all and I thought to mention those first for maximum contrast.

    If you think it is misleading, I will modify it, no problem. Laypeople might be a bit more reluctant to sign it straight away though -- we have to keep that in mind. Including all the caveats will lengthen the text too, which will further hurt the signup ratio. I tried to include relevant links (bottom right) for people who want to look into all the details.
     
  11. JohnnyD

    JohnnyD Senior Member

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    Good usggstions Dany.

    Thanks Fred!
     
  12. Freds

    Freds

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    Ok I updated the petition text. Tried to keep it brief. Still too long -- though Danny is right, it's never black and white.

    If anyone has further thoughts, I'm all ears :)
     
  13. Hope123

    Hope123 Senior Member

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    The ideas above about subgroups and side effects are important to me and would be one reason why I would not sign this petition. It's not merely about weighing side effects vs. benefits. My feeling (and it appears those of the FDA panel majority) is that we don't know enough about side effects even to make a reasonable decision about risk vs. benefit. It's true that we never know (and may never know) about ALL side effects of a drug but it's a matter of degree. The amount of effort Hemispherix put into designing and implementing their trials and following up on patients strikes me as below the standard that even the average drug compay follows.

    My second concern is about what "conditional approval" would mean. The devil is in the details as usual. This might not be a question that the the petition makers can answer since it is under the authority of FDA but what types of mechanisms would FDA require for conditional approval and how would it apply to Ampligen? Would it mean Ampligen having to track patients for Y number of years for side effects and efficacy? Would it mean restriction to the drug for now to patients who are most severe? In that case, what would "most severe" mean? Would it mean that patients are wiling to sign a contract that if unknown side effects occurshort-term or long-term they can't sue their physicians, FDA, or Hemispherix? (The latter I just made up and likely not true but pushing it to the ultimate conclusion here.)

    It's all too vague for me.

    (The other question that occurred to me -- unrelated to this petition - is what would happen health insurance-wise if someone suffered an untoward effect from an experimental drug outside of a clinical trial. Are insurance companies required to cover those complications? Or does it differ from company to company? Will the drug company cover those complications outside a trial? I believe that Medicare has a rule about covering complications stemming from a trial but that is Medicare insurance and not private insurance.)
     
  14. Freds

    Freds

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    I'd like to stress the fact that the advisory committee voted Ampligen safe for approval. Meaning the safety profile is meeting their standards.

    I agree Hemispherx should do more. The submitted trials were too short, for one, but on the whole, enough is known about the drug for patients to make up their own minds (while properly informed and supervised, of course).

    With "conditional approval" I was referring to postmarket conditions such as a REMS program, coupled with a "special use" approval, allowing patients to make their own risk/benefit analysis. See e.g. http://www.fdanews.com/newsletter/article?articleId=145144&issueId=15636

    I removed the term though, it's too vague indeed.

    Your input is much appreciated!
     
    Nielk likes this.
  15. K2 for Hope

    K2 for Hope ALways Hoping

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    Here is an online petition to the FDA to approve Ampligen. Whether we approve of the drug or not, it would be in the best interest of all ME/CFS patients to sign the petition and let them know we are going to start speaking with one voice and there are many of us.

    I will list the link to the petition and then words from Robert Miller. After you sign the petition, it will take you to a page to donate. You do not have to donate to have your signature counted. In fact, you don't even have to comment. It's up to you. When you get to the donate page just close the window.

    http://www.ipetitions.com/petition/ampligen/

    From Robert Miller

    Patients, Family and Friends, We need you. Here is the Start of a campaign on the FDA to Approve Ampligen. Those who saw the FDA meeting know we did not get a fair shake. FDA instructed the Panel to Ignore patients testimony, really, the patients 800 strong and likely more, once Again Do Not Count. Please sign on to this Petition, It only carries Power if you fill in the necessary info. Full Name and Email. Thank you, Robert Miller
     
  16. AFCFS

    AFCFS Senior Member

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  17. K2 for Hope

    K2 for Hope ALways Hoping

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    Good idea. I just want to see people sign the petition so other pharma's enter the race and realize that there is money to be made if someone comes up with a cure....

    Unfortunately, it is money that will drive us to where we need to be...

    Thanks, I didn't see that one.
     
    AFCFS likes this.
  18. Sasha

    Sasha Fine, thank you

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    Bumping... I somehow didn't see this at all until I read about it in a comment on Cort's blog from Bob Miller. Bob is intending to present the petition to the FDA as a print-out when there are enough numbers so let's get signing!

    Here is a link to the front page of the petition:

    http://www.ipetitions.com/petition/ampligen/
     
  19. Sasha

    Sasha Fine, thank you

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  20. Freds

    Freds

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    The petition has been getting a lot of response so far. I've been contacted by several advocacy groups and there's a handful of campaigns starting up to promote the petition.

    Robert Miller will personally be handing over the signature list to the appropriate parties in DC and is coordinating with Cort Johnson on how best to proceed.

    It looks like we're gaining traction, but the petition will need an all-out effort to reach the kind of numbers required for media exposure. The ultimate goal would be Congress -- but we need your help!

    Some Twitter and Facebook activity can go a long way. Ask people to retweet your calls to sign the petition. Reply to sceptics that Ampligen was voted safe. Ask your Facebook friends what they would want. You *can* make a difference...
     
    ggingues likes this.

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