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URGENT: ME/CFS Patient "A C T I ON" for Patients, Family and Friends

Discussion in 'Action Alerts and Advocacy' started by BobM, Jan 4, 2013.

  1. BobM

    BobM

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    URGENT:ME/CFS Patient "A C T I ON" for Patients, Family and Friends

    Organizers: Robert Miller Patient/Advocate, Cort Johnson (Health Rising), Billie Moore Patient Advocate and Team

    Contact: 511bobmiller42@gmail.com

    OnDecember 20th, ME/CFS patients rose to the Challenge and Sent in 750 personal testimonies to the FDA Advisory Committee, requesting for Ampligen approval. 30 Patients, family and clinicians testified. The final vote was split, the panel will recommend to FDA to not approve Ampligen on 3 questions, but voted Yes, that Ampligen's safety profile is adequate for approval on a 4th question .So We Must "ACT". This ACTION will be emailing the contacts below Everyday until FDA approval. We deserve treatment Now. The Final decision date is February 2nd , but it could come any day. We all need to start emailing Today and Everyday.

    (The template below is for you to follow, you can just copy and paste for ease.)

    Email Contacts Are:

    HHS Secretary Katherine Sebelius, FDA Commissioner Margaret Hamburg, Director Janet Woodcock, Deputy Director Sandra Kweder, Senator Richard Blumenthal, Senator Kay Hagen, Congressman Joseph Pitts

    From: PLACEYOUR EMAIL ADDRESS HERE

    To:Kathleen.Sebelius@hhs.gov,margaret.hamburg@fda.hhs.gov,janet.woodcock@fda.hhs.gov,Sandra.Kweder@fda.hhs.gov,Monica.volante@mail.house.gov,

    CC:Karen_Wade@hagan.senate.gov,Eamonn_Hart@blumenthal.senate.gov, 511bobmiller42@gmail.com

    Subject:ApproveAmpligen Now

    From: PLACEYOUR NAME HERE

    The FDA should approve Ampligen by Feb 2, 2013. The advisory committee voted that Ampligen's safety profile is adequate for approval. Patients and our physicians must have the opportunity to access a treatment that has shown such promise for ME/CFS patients. Failure to do so will leave us with no FDA approved options to treat this disease.

    The FDA has stated that ME/CFS is a serious and life threatening disease. Yet, without treatment, patients and their families are left to suffer. Many of us are bedbound or homebound. We are in constant pain and suffering, abandoned to bodies that torture us every day and demands that we parse out our activities like a single piece of bread that must last for a month. According to a DePaul study, patients are more likely to die prematurely from cancer, heart failure or suicide. This is the long-term reality of living, untreated, with ME/CFS. Imagine living with an untreatable disease so terrible that you would choose suicide to escape it.

    750 written and over 30 in-person patient testimonies, including that of the AAC patient representative, conveyed how this devastating disease impacts our lives and the imperative of weighing the opportunity to benefit against the risk of no treatment to escape from this terrible physical burden and get back even a piece of our lives.

    For us, even small improvements have a very significant impact on our quality of life, which were dismissed by FDA statisticians. It's evident that Ampligen has provided benefit to patients, with the testimony and data pointing to meaningful change in our ability to function and care for ourselves.

    The true nature of this disease and the plight of patients have been ignored for too long. Patient testimony and patient and clinician experience provide evidence that this drug works in many patients. A number of AAC members agreed that Ampligen helps and other members noted that they saw an indication of effectiveness in some patients.

    Let patients and their doctors decide whether the only treatment in FDA clinical trials for ME/CFS is the right medicine to provide relief from the living death that is our reality today. Remember that the disease itself has a collateral impact that creates its own serious risks for patients.

    The advisory committee voted that Ampligen's safety profile is adequate for approval.

    Approve Ampligen by Feb 2, 2013. Anything less is condemning ME/CFS patients to years more of continued suffering without any hope of relief.
     
  2. xchocoholic

    xchocoholic Senior Member

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    Hi Bob,

    I'm interested in pursuing Ampligen as a possible treatment for my disabling me/cfs. But I'm confused.

    Can you tell me exactly which PWCs, based on lab results, benefit from Ampligen ? Is there a specialty lab where these
    tests need to be taken ? Just out of curiosity, what tests will GP's on the frontline use to determine which of their patients will benefit ?

    What criteria, including ALL exclusions, is used to determine eligibilty of PWCs who would recieve Ampligen ?
    Is there an age limit ? Will it help those of us who've been sick for 20 + years ? What co-factors, such as heart or lung conditions, would exclude a patient ?

    I understand it's only available via IV, so how would those of us who are mostly housebound receive this therapy ?
    Many of us have frail veins so multiple IVs are extremely painful. Does Ampligen help this ?

    Tx .. X
     
    BobM likes this.
  3. Kati

    Kati Patient in training

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    X you are asking many questions that are difficult to answer.

    Ampligen is not necessarily a drug that a GP would prescribe, but a Me expert. It is currently a twice a week IV drug,and if your veins are not accessible or too difficult, then a central line ( PORT or PICC) needs to be inserted. I believe Hemispherx is workingon a subcutaneous ( injection under the skin) form, but I may be wrong.

    As for criteria of eligibility, it is unclear who benefits, but I personally believe that viral onset would most benefit. The eligibility criterias are currently strict because it is still an experimental drug. A ME expert dispensing the drug would be best answering these questions.

    This said, everyone in the ME community benefits in having one drug approved for our disease. Please send out your emails to the FDA.
     
    BobM and taniaaust1 like this.
  4. xchocoholic

    xchocoholic Senior Member

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    Hi Kati,

    Sorry about all the questions. I'm just confused on what ampligen does.

    I'm just a patient so I look at drugs in a simplistic way. Meaning, based on what I've been reading on the web and how my doctors dispense certain meds, they know how antihistamines, antibiotics, anti parasitics, pain meds, chemo, etc work based on "clear" research. Most of us have seen first hand how these meds work too.

    So does Ampligen work on pain ? If so, how exactly ? Does it kill bad bacteria or parasites or other pathogens ? Does it help control mast cells or block mast cell receptors ? Does it affect our immune system directly ? If so, how exactly ? Do patients still need pain meds, mast cell blockers, etc ?

    Is there an ME expert who has the answers to who would benefit ? Where is the criteria for studies on Ampligen ? I'm not sure where to look.

    FWIW, what's the point of having a "single" drug for ME/CFS if only CFS experts can dispense it ? There are only a few of these doctors and they're difficult to get in to see. Some of them don't accept insurance. Many of us are disabled and can't afford to see these doctors or have the energy to travel.

    Would approving this drug as the single treatment for CFS lock up CFS treatments to only specialty clinics ? If so, that's not fair to the millions who can't get it.

    tc ... x
     
    BobM likes this.
  5. CallieAndToby

    CallieAndToby Senior Member

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    Yea I emailed them. I will continue harassing them daily. Thanks for update. My M.E. was virally triggered.
     
    bluebird and BobM like this.
  6. Sasha

    Sasha Fine, thank you

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    Hi x - I don't know the answers to your specific questions about Ampligen and, being in the UK, I wouldn't get it anytime soon even if the FDA approved it. However, getting the FDA to approve Ampligen is hugely important because having an immune therapy (which is what Ampligen is) approved for our disease by the FDA will validate it as a genuine immune disease. This will open the doors to more research funding, other drugs, and more accessible, humane and appropriate treatment for all of us.

    I've sent off my first email using Bob's template and I'll keep on doing that daily now until we hear a decision. :)
     
    PhoenixDown and BobM like this.
  7. BobM

    BobM

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    Ok, So lots of good questions. Lets start with How the drug works, It is an Immunomodulator. It alters the immune system, if yours is upregulated or downregulated, Ampligen brings the immune system back to a normal or closer to normal balance. Does it help with pain, yes, but remember that this is not an antibiotic, so the action takes more than a few days. It takes time to change the immune system, some feel a response in a few months and others 6 or more months. Pain, brain clarity, functionalability all improves as your system adjusts. How do the illest patients get the drug, I was bedbound when I started, so I had to take a cab at times for an iv. On do you still need other Meds.: The studies showed Ampligen patients used far less medications (scripts and over the counter) than those not on Ampligen. Also length of illness may play a large role here as some patients ill for 2 to 3 years seem to improve faster with a better response than a patient ill for 20 years, such as myself. Who will be able to give Ampligen, Hemispherx has a program to educate doctors that would be tied to the approval. So joe blow MD could not give Ampligen. There are many clinicians with experience of giving immune altering drugs, so they would be great doctors to set up a site.

    Hope this Helps......
     
    Kati, CallieAndToby and Sasha like this.
  8. On the bright side of being poor, unable to see the elite physicians who serve the elite ill, of losing 20 years of my life to suffering, disability...wait...there is no bright side. I did send the letter though. Will send everyday for a month. No problemo. Cat Se-'bilious' already auto-replied. yipeeeeeeeeeeeee ~
     
    CallieAndToby and BobM like this.
  9. BobM

    BobM

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    You can find a complete version of this at Cort's New site as well.
    http://www.cortjohnson.org/blog/201...ends-to-support-ampligen-approval-at-the-fda/
     
    bluebird likes this.
  10. CallieAndToby

    CallieAndToby Senior Member

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    It is an antiviral too, no?

    I've also heard it fixed dysautonomic problems; one theory being viruses trigger them.
     
  11. CallieAndToby

    CallieAndToby Senior Member

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    LOLOL. Yea somebody auto-replied to mine asking for money - hahahahahahaha.
     
  12. taniaaust1

    taniaaust1

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    Ive decided to send a letter in every day if Im able to... cant do so today as Ive lost my password yet again for my email account and have lost my phone changer so now have a flat phone, so cant ring up anyone asking what my password is (and dont have the energy at all to be up on feet looking for the lost objects today, my house is so trashed right now I'd be lucky to find it even if I was feeling good enough to be able to be looking). sighs.. this illness really makes things hard.

    Anyway. I send my first letter yesterday using the suggested letter here but added to it how long I'd been ill for and that Im on disability payments due to the illness (and forgot to put a name to the letter before I sent it). Ive written out todays letter (to hopefully be able to send it tomorrow). I got the idea to with this daily email thing, to write about each day and how the ME/CFS has affected me that day and send it to them. Like a day in the life of a ME patient and what Im living throu hence why I want to be able to trial Ampligen. Hoping that will interest someone enough to actually read my emails to them.

    anyway.. today my letter Im wanting to send is reading

    "
    Im going to be briefly sharing my experiences with ME/CFS to you (if I can) so hopefully will help to gain more understanding on just how bad this illness is to live with and hence why those like myself really need the urgent approval of Ampligen. I got this illness over 15 years ago and are on disability solely due to it. I was 26/.27 years old when I got this disease. I can not take care of myself and have support workers to take care of daily physical needs due to it.

    Yesterdays mail to you asking about this, I think I may of fogot to put my name at the bottom of the mail due to the memory and concentration issues of the ME/CFS so today, hopefully I will remember to do this. Today... I was in bed till after lunch time as Im sore and completely exhausted as Im in the middle of a house move and due to the 4hrs of physical activity yesterday which I did in a 24 hr period (sitting and on feet activity, my best in a way long time usually i can only do half of that)... my body is now in payback mode for doing that.

    The house Im being forced to move away from is due to my ME/CFS too. Im currently living in a country area but due to the ME/CFS have to move house so Im closer to my MANY specialists. Im currently having to be "taken" (as I cant drive myself due to the illness.. I smashed up TWO cars while trying to drive while tired when I was still being forced to try to work before I got onto disability payments. I also was accidently driving throu stop signs.. as my brain wasnt working well). . Im lost friends over all the help I need and in the end many people end up avoiding me as they get frustrated over the situation Im in and "you are too much work", others end up in dismal over my situation and feel bad themselves. Ive even had one person loose his own job over taking me to my medical appointments as I had no other way but to keep asking for his help to get me to my specialist appointments.

    For the medical issues I have (mostly ME/CFS related) the specialists I see are a gyno, allergist, 2 nutritionists as I have hypoglycemia etc, food intollerances and multiple food issues, 2 different CFS specialists, a physiotherapist, a supporting psychologist (to help me to deal with the stress this illness causes and to help give me ideas when I run into trouble with things.. mostly the biased I get from others towards this illness), a gastro (the IBS-C from the ME/CFS gave me a bowel prolapse so I wasnt able to go to the loo naturally).
    Last year I also was seeing an othopedic specialist.. as I developed a frozen shoulder which Id had for almost 2 years.. due to the age that occurred, the specialist said my abnormal healing response was "autoimmune" in some way related. Anyway.. Im a ME/CFS patient who sees 10-11 specialists A YEAR for my medical issues, that is on top of my normal two doctors. I end up in hospital 1-5 times per year usually due to this illness. Last year I was hospitalised due to an accidental OD on the drugs I take for the symptoms of my ME/CFS.. my brain confused my dosages and hence me ending up on a drip in hospital. The year before I spent a week in hospital on a drip with double pneumonia. I got to be taken to specialist or a doctor 1-2 times a fortnight. Its sad to be this ill when stil young.

    Over the years Ive seen approx 35 different doctors (non specialists) before I started seeing the countless specialists doctors refered me too who started running more tests and finding abnormalities. This illness makes my life have to revolve around medical doctors and specialists and Im currently having to seek up yet another one for postural orthostatic tachycrdia syndrome POTS (another coexisting conditon of my ME/CFS) as my current specialist is at loss on how to treat it as the common drugs for it isnt enough as its a severe case (I probably need daily saline IVs). The POTS I have due to the ME makes me have unconscious collapses which are triggered off by being up on my feet, I also get seizure like incidences.

    Todays symptoms are lethargy to the point where Im mostly stuck in bed today and Im having incidences of drawling (saliva) down my face (I dont seem to be automatically swallowing or something?? or having some kind of mini seizures??? I dont know why Im having the drawling incidences) and also all body soreness from overdoing it yesterday. For some of the symptoms ME/CFS patients have, with severe ME patients often having nearly all of these (I get over NINETY different symptoms or blood test abnormalities with this illness eg D deficiency, hormonal deficiencies etc etc).. please check out http://wwcoco.com/cfids/bernesx.html

    Yours Sincerely
    Tanya Selth
    (an Australian severe ME sufferer who wants to see Ampligen approved. I want to trial it myself. Please help people like me get access to this drug).
     
    Please, please help get Ampligen aproved for ME/CFS patients like me. I want to be able to trial something which just "may" help. Give me and those like me a chance to improve and be not as ill. I hate being dependant on others just to live the very limited life I are living.
     
    Sasha likes this.
  13. taniaaust1

    taniaaust1

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    Maybe send them another email back.. asking if they would considering donating to one of the ME/CFS groups :p

    I got one auto reply back yesterday too..but it wasnt that one. Im still wondering if all mine went throu or if only the first name email address on it did.
     
  14. Sasha

    Sasha Fine, thank you

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    I got one autoreply from Kathleen Sibelius - I expect the others just don't have an autoreply system turned on.

    There is a minor typo in the email addresses - there needs to be a comma in the email addresses after ‘janet.woodcock@fda.hhs.gov’ for people to be able to cut and paste that in and have it work.
     
    taniaaust1 likes this.
  15. taniaaust1

    taniaaust1

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    Thanks.. my head couldnt work out what was wrong with that.. so I ended up doing her a separate one.
     
  16. Sasha

    Sasha Fine, thank you

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    You're welcome! The email list in my article on the home page has that comma in so you can cut and paste that version - Mark has also added a clever button that puts the email addresses in for you and opens an email program (some Windows thing) if you want to use that. I'm more Stone Age so I'm still cutting and pasting.
     
  17. BobM

    BobM

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    The email list has been altered due to guidance from Senator Casey's office. Please use the updated email list.
    Thank you, Bob Miller
     
  18. Sasha

    Sasha Fine, thank you

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  19. BobM

    BobM

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    The reason I requested for Sen. Casey's office to be removed is due to their office not being Tech. savy enough to create Outlook folders(Really). The hundreds of emails just overwhelmed their office. They have been supportive of the contact with the FDA from early last year when our group contacted them to give us support for the ME/CFS stakeholder meeting coming this spring. The guidance I refer to above is a request that I screen the emails I have from the first wave of emails sent by people who live in Pennsylvania and forward them to his office. They acknowledge the emails they have received and are still getting.
    I would like to remind everyone that in November during the FDA webinar, the FDA suggested that patients needed to be advocates and engage Congress, like the HIV/AIDS advocates did. So anyone thinking that sending emails daily is bothering our Representitives or FDA, we were actually encouraged to do so by FDA. Per the webinar: Richard Klein, from the FDA’s Office of Special Health Issues spoke about patient advocacy as it was carried out for HIV/AIDS in the early days. So email daily, we are currently emailing about 350 emails daily, if we could hit 500 that would be great.

    I thank you for your support and for taking action to change your health,
    Kindly,
    Bob Miller
     
  20. Sasha

    Sasha Fine, thank you

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    Thanks, Bob, that's all good to know - I think in the last few years the community has become more comfortable with more assertive email campaigns but it's nice to know that the people on the receiving end actually welcome them!
     

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