We need a way to treat patients.
Take Action
Patients Needed:
PART 1: Instructions to Take Action 
To All ME/CFS –S.E.I.D. Patients, Family and Friends,
As most patients know the IOM and NIH P2P have released some positive findings in our disease. While there is debate re: the new name S.E.I.D., there is no debate at all that we need treatments.
Patients must stand together:
{From the recent Hornig et. al. study. “If replicated in longitudinal studies, these data may provide a basis for early immuno-modulatory intervention to prevent long-term, recalcitrant illness”. In fact we already have an immuno-modulatory drug that’s proven to help with ME/CFS: it’s called Ampligen }
The FDA admitted prior to and during the Advisory Committee meeting for the approval of Ampligen, that they did not fully understand this disease. They have agreed that it is a serious disease – but they’re not treating it like one.
Consider:
(1) that the FDA Advisory Committee Voted 8 to 5, that Ampligen is safe for this patient population.
(2) that the FDA has stated it has no safety concerns regarding Ampligen.
(3) that the FDA has stated ME/CFS is a serious disease and that ME/CFS patients urgently need treatment options
(4) that two recent federally funded IOM and P2P reports underscore the immense need for treatment options for the million Americans with this disease.
(5) The FDA has done nothing to alleviate the suffering of people with ME/CFS…but it could
It’s clear that Ampligen presents minimal risks and large potential rewards for a large, drastically underserved community. The recent IOM Report from the National Academy of Sciences and the NIH’s P2P findings gives us our best opportunity yet to push for FDA approval of Ampligen.
That‘s why we are asking patients, family and friends to email the below request to those our representatives in Washington D.C. and at the Department of Health and Human Services (DHHS).
This is step one of many to finally get a treatment approved for ME/CFS. With approval will come insurance coverage for all, and more treatments as other companies see the potential for profits.
(There is a template Email below to follow if needed and you can copy and paste for ease). Again it is only a template or a guide, use your own voice and “Let Your Voice Be Heard”
Please send in your email ASAP.
Thank you for Taking Action for Yourself and “Those Unable” to do so.
Kindly,
The FDA Action Team
Some may need
Some may need to Cut and Paste from the PDF Icon below at the bottom of the page next to the Print Icon, if you have any difficulties.
Part 2: Please cut and paste the below addresses into your email T0 Box:
monica.volante@mail.house.gov; sarah.curtis@mail.house.gov; Elizabeth.brown@mail.house.gov; dennis.sills@mail.house.gov; mark.ratner@mail.house.gov; james.paluskiewicz@mail.house.gov; scott.dziengelski@mail.house.gov; thomas.power@mail.house.gov ; janet.woodcock@fda.hhs.gov; Nancy.Lee@hhs.gov
(Emails are for staff of Congress members & Dr. Woodcock of FDA, Dr. Lee at HHS.)
Listen to the experts and patients.
Cut & Paste into SUBJECT LINE: Hearing Request for Treatment Denial
Cut & Paste Below into EMAIL MESSAGE:
To: The Honorable Congressman Joseph Pitts Chairman, Energy and Commerce, Subcommittee on Health
To: Representatives Reid, Kennedy, Castor, Butterfield, Upton, Burgess, Murphy, Bilirakis
Cc: Janet Woodcock, Director, Center for Drug Evaluation and Research, Nancy Lee HHS
REQUEST: A Hearing/Adjudication to Examine the Failure to Provide Treatment that has the potential to positively impact 40% of the population living with ME/CFS.
You may have recently seen the report issued by the Institute of Medicine (Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness, 2015) which stated that Chronic Fatigue Syndrome is a legitimate disease that needs diagnosis and treatment.
We have been calling on the government for decades to support ME/CFS. While we are grateful for the IOM report until the spirit of the report is acted on – and approved treatments exist – the report is simply more words to a community that has been hearing nothing but words for decades. Until approved treatments for ME/CFS exist the million people with ME/CFS will continue to suffer – many of them needlessly.
We, therefore, request that you call a hearing to examine a treatment that has shown promise for 20 years. Experts agree that between 20-40% of patients see improvement and without a doubt it would open the gate for greatly needed biomedical research and innovation.
Your oversight powers enable you to ensure that drugs receive a just and fair review based on an appropriate risk-benefit assessment. We don’t believe this has happened with Ampligen and we’re not surprised given the FDA’s public statement that they do not understand this disease.
We therefore ask that you bring experts in who do understand this disorder in order conduct an open and objective hearing on the pro’s and con’s of Ampligen approval for ME/CFS.
Cost Estimates: Using ME/CFS prevalence data of 0.42 and indirect costs estimates from Reynolds et al. (2004), the direct and indirect cost of ME/CFS to society is estimated to be $18,677,912,000 for the community sample and $23,972,300,000 for the U.S.. These findings indicate that ME/CFS imposes substantial economic costs to the U.S. economy, that many are suffering and all deserve to have valid treatment options.
NIH currently spends $ 5 Million annually on a disease that costs the U.S. economy 20 plus billion dollars a year.
Sincerely,
Your Name HERE:
Years of Life Lost to CFS, Number Here:
Done! Thanks, Bob, for lining this up.
Awesome Greg, Thank you!!!
Cort, it’s good to see advocacy coming off the back of recent events and I’m sure a lot of us will support this but I’m concerned that there’s a much bigger issue than Ampligen – the tiny, $5m a year spent by the NIH on our disease.
With the IOM report, the P2P report, and last week’s Hornig/Lipkin cytokine paper, we have a unique opportunity to push the NIH for $100m a year, not $5m.
I so clearly remember Bob at that CFSAC meeting, saying, ‘I’m worth more than $3.64, so here’s the three dollars and sixty-four cents that you spend on funding,’ and slamming his handful of coins down on that table. That’s here at 1:12, for anyone who hasn’t seen it:
https://www.youtube.com/watch?v=VSLHT88o0IQ
Are you and other advocates planning a timely action on this wider issue of NIH funding? The IOM report came out on 10 February, over three weeks ago: there’s only so long that these things are fresh in people’s minds. I’m worried that we’re going to let this opportunity slip.
Great comment and great questions, Sasha – I absolutely agree.
Sasha, you are right, The time is Now to hit the NIH up for funding. The call for the Hearing has been in the works for a little while, the is a process, so contacting Key Reps. on the Health and Commerce committee for treatment will get them aware of the Need. There is an Action as a step 2 to get increased NIH funding being prepared. Having Dr. Lipkin on Dr. Oz today should gain awareness, he should call for increased funding during the show.
Thanks for you input.
Thank you, Bob – I’m grateful and excited to hear that there’s a second campaign on the way. I think it’s important to communicate that to patients – I think it’s what we’re all waiting for, and if people understand that the call for the Ampligen hearing is Step 1 of a two-step strategy to get what we need, they’ll be more likely to support that first step as well.
I’m not able to watch the Dr Oz show here in the UK – I don’t know what Dr Lipkin was able to do, in the end. I gather it’s pretty easy for comments the editors see as off-topic to end up on the cutting room floor on shows like that.
Anyway, exciting times! We need to get this second wave going as fast as we can. Looking forward to hearing about it.
Thanks again, Bob, and to you, Cort, for hosting this.
Bob, does ‘Part I’ at the top of this piece refer to Part I of a campaign to get an Ampligen hearing? Or is this Ampligen issue Part I of a broader campaign and Part II is the general funding issue? At the moment it reads like the former because it follows the main title, which is about requesting an Ampligen hearing.
Sorry to bombard you with questions! I just want to get my facts straight before I repost this elsewhere.
I agree with you Shasa.You have hit the nail on the head.After these latest reports and the amount of suffering we indure and god knows the many who have taken their own lives because nobody understands including 80 percent of the doctors of this
Hurrendous disease .I am so happy to see this day.As in this article we have to bind together as sisters and brothers and take this fight on and let our voices rise up and be heard with each of us writing and following through with this call.I want to Thank all of you for just knowing that you are out their and that i am not alone in my silent suffering.I feel you all and i know god hears our cries and prayers and i believe now with all my heart that we all are living in a time of break through with our government coming on board and with unity we can take this stand and expect change.Please take the time and answer the call and write.I pray one day that we will have answers to all our questions and medications to insure a better quality of life and most of all a cure.May god grant us all wisdom,patience and better quality of life.
Hi David,
Very powerful reply, thank you for sharing it with me and all patients. We patients need one another, we all may be in slightly different situations, but we know what it takes to survive each day. These patients, you patients, you as people are the most incredible people I have ever known next to my sisters who were born with cancer. The strength it takes to keep Hope and pushing through every day is unreal, only other patients and loved ones really know.
Done. Thanks, Bob for your faithful advocacy.
Ampligen needs approval!
I live in England so I don’t think that adding my voice to the petition is relevant as my disease affects my government’s economy not yours. But I wanted to add my voice to you all & say that I love your spirit of comaraderie & to let you know that I hear you all even tho I am in a different country.
I have just won a long battle with our benefits department & received an open ended award for disablement benefit, back-dated to 2008. I am saying this to support the fact that fighting unfair decisions can bring justice eventually & this happened before the strength added to our arguement by the puplic agreement to recognise our disease.
I liked the lovely letter about praying into this situation & I join with that person in inviting God into this fight for justice for all sufferers of this devastating disease.
Your voice counts. Please send an email. If Ampligen gets approved in the United States, other countries will likely follow suit. In addition, with Ampligen’s success in treatment for ME/CFS/SEID, there will be additional competition between pharmaceutical companies to bring other medications to the market. Also, health professionals in other countries that still believe ME/CFS is “all in our heads” will see that Ampligen works for a large subgroup of CFS sufferers, and they will have to face the fact that this is a physical disease, not a mental disorder. So, it could help change the thinking of influential health professionals in counties that are “behind the times” in their thinking & treatment.
Good job! Can we please have a campaign set up similar to this for funding of research asking for 100,000,000!
Oops was so excited that I posted before reading properly! Great that a campaign is going to be outlined for NIH funding. So pleased to see. Can people from other countries join in the campaign?
Hi Bob –
I tried twice to send the e-mail and received the message below. Any suggestions on how to fix? If I can resolve this I’ll expand the effort and ask my family and friends to send it too.
(You don’t need to post this – just help me resolve it if you can – and I’ll leave another reply you can post when I’m successful).
Thanks.
Delivery to the following recipient failed permanently:
monica.volante@mail.house.gov; sarah.curtis@mail.house.gov; elizabeth.brown@mail.house.gov; dennis.sills@mail.house.gov; mark.ratner@mail.house.gov; james.paluskiewicz@mail.house.gov; scott.dziengelski@mail.house.gov; thomas.power@mail.house.gov ; janet.woodcock@fda.hhs.gov; nancy.lee@hhs.gov
Technical details of permanent failure:
Google tried to deliver your message, but it was rejected by the server for the recipient domain hhs.gov by smtp.ees.hhs.gov. [158.72.139.19].
Jody, Click on the PDF link bottom of the page and copy any text or emails from there, it seems to work better…Let me know if that works for you.
Thank you!
I’m in Canada. Will it help if I send an email?
Yes. Please send an email.
If Ampligen gets approved in the United States, other countries will likely follow suit. In addition, with Ampligen’s success in treatment for ME/CFS/SEID, there will be additional competition between pharmaceutical companies to bring other medications to the market. Also, health professionals in other countries that still believe ME/CFS is “all in our heads” will see that Ampligen works for a large subgroup of CFS sufferers, and they will have to face the fact that this is a physical disease, not a mental disorder. So, it could help change the thinking of influential health professionals in counties that are “behind the times” in their thinking & treatment.
Formatted email, dropped in addresses and sent. However, it bounced back with the following message:
Technical details of permanent failure:
Google tried to deliver your message, but it was rejected by the server for the recipient domain hhs.gov by smtp.ees.hhs.gov. [158.72.139.19].
Helpl please?
Don’t know why, I probably sign 10 petitions a day but the one’s you set up never actually get through, they always get returned! Most of the petitions, and they’re for MAJOR actions, are to one or two representatives assistants.
Thanks to Bob, Cort and all who are participating in this needed campaign!
I sent the message in, and the addresses went through with no problem for me. I did have to delete the verbiage that is automatically attached to anything copied from Cort’s website. On my gmail account, the verbiage–something like, “Read more at…”–twas sort of behind the addresses. I was able to catch the end of the string that wasn’t an email address and delete it. I’m wondering, Gregory Cutler, if this problem might be preventing your emails from going through…. I hope this will help someone else participate in such an important campaign at just the right moment.
Again, huge gratitude to Cort and everyone on the FDA Action Team.
Oh, and for folks not in the US, since the template does not call for saying where you’re from, it seems to me like it’s worth a try to add your voice. And, thanks for doing so!
The Dr. Oz clip was AWFUL. The bubblehead doctor obviously had not read the report or even the short pamphlet for doctors; probably some other bubblehead on her staff created her script. The woman is clearly working to be a celebrity doc. She called the New Disease “systemic exertion intolerance DISORDER.” And the charts that were created to show what the symptoms are were so off the mark they had no relation to what the IOM wrote and what we know about the symptoms. If that is the level of the Oz show, he is probably misinforming millions every day. I did not get to see the whole show; understand Lipkin had some useful things to say. In parts of the country the segment about ME/CFS/SEID were canceled out by a breaking news item about the plane that skidded off the runway at LaGuardia. Good thing!
Instead of Reynolds et al. (2014) at the end of the letter, shouldn’t it be Jason et al. (2008)?
http://www.researchgate.net/publication/5454263_The_economic_impact_of_MECFS_individual_and_societal_costs
Oops, sorry – I see that Jason et al. cite Reynolds. My bad!
Am I missing something? I don’t see Pitts’s email address in the list.
The email addresses are for their staffers who see the emails first.
Emails sent!
Another distraction. Ampligen is not the answer
Done. Now I’m off to work on an e-mail to the NIH. I agree that funding is the much bigger issue.
Done.
Trying to spread in facebook where I can.
Ampligen going for approval for use in ME through a collaboration with Emerge in Australia and New Zealand.
http://www.hemispherx.net/content/investor/default.asp?goto=819
Thank you Bob. My tweak:
Your committee has a lot of power. You can decide to help this community find meaningful treatments or can decided to allow us to needless suffer. Your committee is the gatekeeper and at this moment you are keeping us from participating in society and our personal lives. You are keeping us from work, education, birthday parties, graduations, etc. All we want is the opportunity to be heard and to have a viable path to meaningful treatment.