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Bob Miller calls for NIH trial for Ampligen: phone & email to support his ongoing hunger strike

Discussion in 'Action Alerts and Advocacy' started by Sasha, Feb 6, 2013.

  1. Sasha

    Sasha Fine, thank you

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    Edit: There's a new/additional action requested by Bob: "I would ask All to call their Reps. and call Assistant Secretary Koh at 202-690-7694 it is a direct line in. Tell Assistant Sec. Koh to ask Sec. of Health Sebelius it is time for her to get involved."

    Bob Miller is heroically continuing his hunger strike after the FDA's failure to approve Ampligen for ME/CFS patients. He's now into Day 9 and calling for two new actions by patients: to email federal officials to get the NIH to do a clinical trial for Ampligen and for US patients to contact their local NBC affiliate to pick up the Reno KRNV story.

    Cort has a post by Bob on his Health Rising blog about this:

    http://www.cortjohnson.org/blog/201...f-only-medicine-for-chronic-fatigue-syndrome/

    I don't see a template email so if you'd like one, please feel free to use or adapt this one I came up with or post something better :) :

    **********​

    To: margaret.hamburg@fda.hhs.gov, howard.koh@hhs.gov, jarrettpublic@who.eop.gov, Kathleen.Sebelius@hhs.gov

    Subject: ME/CFS patient on hunger strike for NIH trial of Ampligen

    Message:
    Long-time ME/CFS patient Robert Miller from Reno, Nevada began a hunger strike on 29 January to show patients' desperation for the FDA to approve Ampligen for use in ME/CFS.

    The FDA disapproved the drug and Mr Miller continues his hunger strike, requesting that the NIH conduct a clinical trial into Ampligen.

    I support Mr Miller. The NIH spends only $6 million a year on ME/CFS while the disease affects 1 million Americans, costs the US government $20 billion a year and disables 25% of those whom it afflicts.

    I want my life back, just as many of those on Ampligen have had their lives back. Many of us have been sick for decades and we can’t wait any longer. Please start an NIH trial of Ampligen and give us a future.

    Your Full Name Here:
    Address Here:
    Years ill:

    **********​

    Bob also says:
    Patients, please call your NBC affiliate to ask them to pick up the Reno KRNV story http://www.mynews4.com/news/local/story/FDA-denies-drug-for-Chronic-Fatigue-Syndrome/SboLsPYRqkekVYQN8cCfsQ.cspxt
    The TV news story can be seen here http://bit.ly/XzvFVQ
     
    BEG, Merry, Nielk and 1 other person like this.
  2. Sasha

    Sasha Fine, thank you

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    You can also share, tweet, whatever those KRNV stories and can comment - it takes either email registration or Facebook to do that. Giving that story a lot of traffic and comments might help other stations to see it as attractive.
     
    BEG and Nielk like this.
  3. Nielk

    Nielk

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    Thank you Sasha for informing us and providing the e-mail template. I just sent mine out.
     
    Merry, snowathlete and Sasha like this.
  4. Merry

    Merry Senior Member

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    Thanks, Sasha. I sent out a request for the NIH trial but I forgot to copy Bob.
     
    snowathlete and Sasha like this.
  5. Sasha

    Sasha Fine, thank you

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    I don't actually know if he wants copying or not - I posted a question on Cort's blog about that. He put his email on the list of earlier action emails. I'll post here when I find out.

    Edit: Bob's email from his earlier email campaign is bobmiller42@gmail.com. I still don't know if he wants to be copied in.
     
  6. Merry

    Merry Senior Member

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    Yes, I don't know either. When I write to the White House and to my representatives in Congress, the message goes in the contact box at their website, and there isn't any way to copy Bob.
     
    BEG likes this.
  7. LaurelW

    LaurelW Senior Member

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    Thanks for the template. Done!
     
    BEG and Sasha like this.
  8. Sasha

    Sasha Fine, thank you

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    Likewise done here - I was so busy posting this thing that I forgot to send my own email! :eek:
     
    BEG and snowathlete like this.
  9. BobM

    BobM

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    Sasha, Thank you. We are working hard here, but as you can understand my abilities are faltering and my wife is running on empty. I would ask All to call their Reps. and call Assistant Secretary Koh at 202-690-7694 it is a direct line in. Tell Assistant Sec. Koh to ask Sec. of Health Sebelius it is time for her to get involved.

    Thank you All for the support and Help. Sasha please post this info on Health Rising.

    Kindly,
    Bob Miller
     
    BEG likes this.
  10. Sasha

    Sasha Fine, thank you

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    Thanks Bob - I can understand how exhausted you must be.

    I've posted your reply on Health Rising.

    Please take very good care of yourself and stop if you need to - none of us want you to get sicker.
     
    WillowJ and Nielk like this.
  11. peggy-sue

    peggy-sue

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    I wish he would stop now. :cry:
    I'm getting very, very concerned about the long-term damage that might well result from this.
    He has a family who love and need him.
     
    Merry likes this.
  12. Merry

    Merry Senior Member

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    Kati likes this.
  13. Sasha

    Sasha Fine, thank you

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    Thanks - just read it, you're right, it's really good. I emailed Mr Osborne to thank him.
     
  14. peggy-sue

    peggy-sue

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  15. Sasha

    Sasha Fine, thank you

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    That's good - it requires a log-in, though, and it seems to be for health professionals. I can't see it (too tired to go through the rigmarole).

    Is it a good piece?
     
  16. peggy-sue

    peggy-sue

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    It's a good site for getting papers in the original - registering is free. Here's the article, copied and pasted.
    Doesn't say much really, I just thought it was of relevance because Bob got into it.
    here it is:




    The US Food and Drug Administration (FDA) has sent Hemispherx Biopharma a Complete Response Letter (CRL) regarding the new drug application (NDA) for rintatolimod (Ampligen) for chronic fatigue syndrome (CFS), according to a news release February 5 from Hemispherx.
    The FDA declined the NDA, requesting that Hemispherx perform at least 1 more clinical trial, as well as additional nonclinical studies and data analyses before the agency would reconsider the NDA. According to a company news release, Hemispherx intends to seek an end-of-review conference with the agency.
    The CRL states that data from 2 pivotal clinical studies that were submitted in the NDA do not offer substantial evidence that rintatolimod is effective in treating CFS. Because of size limitations of the safety database and several discrepancies within the submitted data, the FDA stated that the available evidence was insufficient to assess safety of rintatolimod in patients with CFS.
    The FDA and Hemispherx agree that in clinical study AMP-502 the primary efficacy endpoint was met with a level of significance of P = .02. For the second study, AMP-516, the P value calculated by the FDA was .10, in disagreement with Hemispherx's analysis yielding a P value of < .05. Hemispherx therefore contends that in both pivotal clinical studies the primary efficacy endpoints were met with a statistically significant improvement.
    Despite the disagreement regarding the P value, analyses of AMP-516 by the FDA and by Hemispherx both showed improvement with rintatolimod compared with placebo.

    Safety data submitted by Hemispherx were from the 845 study participants assigned to rintatolimod, including 589 participants with severe CFS and more than 200 patients with CFS who received rintatolimod for 1 year or more.
    Hemispherx claims that these data are sufficient to establish the safety profile of rintatolimod. At the FDA Advisory Committee meeting held December 20, 2012, 8 of 13 members voted "yes" regarding "Is the safety profile of rintatolimod adequate for approval for the treatment of CFS?"
    Before submitting a formal appeal to the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, Hemispherx intends to seek an end-of-review conference with the FDA about their declining the NDA for rintatolimod in CFS. Their goal is to review issues cited in the CRL, the corroborating data, and experiences of clinicians and patients regarding the benefits of rintatolimod treatment in CFS.



    Hoping for FDA approval of rintatolimod. a CFS advocate and patient treated with rintatolimod since 1999 through a treatment IND began a hunger strike on January 30, 2013. Hemispherx has requested that any hunger strikes be discontinued and that patients collaborate with the FDA, the company, clinicians, and patient advocates to resolve the significant unmet need for CFS treatment.


    "FDA has an important role to play in shaping the future of medical breakthroughs by bringing stakeholders together to identify and overcome challenges," FDA Commissioner Dr. Margaret Hamburg said in a previous statement.
     
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  17. Sasha

    Sasha Fine, thank you

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    Thanks, peggy-sue - you're right, that's a big deal to get onto Medscape.

    If anyone is Facebook-competent, here's Bob's campaign page, if anyone would like to alert him to these snippets - I'm sure he'd like to know! Facebook is beyond me.

    http://www.facebook.com/HungerStrikeForAmpligen
     
  18. Ember

    Ember Senior Member

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  19. Merry

    Merry Senior Member

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    Thanks, peggy-sue. I posted on Bob's Facebook Hunger Strike page (said peggy-sue at PR had found it). I looked but didn't see the info had been posted previously, but I'm getting tired and could've missed it.
     
    Sasha likes this.
  20. Merry

    Merry Senior Member

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    Nielk, yes, I received this letter. I can't say what the significance of it is.
     

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