- Organizers: Robert Miller Patient/Advocate, Cort Johnson (Health Rising) , Billie Moore (Patient Advocate) and Team
- Contact: 511bobmiller42@gmail.com
On December 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: Approve Ampligen 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.
It’s NOT a done deal. Ampligen didn’t win out but it did get a potentially critically yes vote.
While the panel did not vote that Hemispherx had sufficiently proved that Ampligen was effective or safe enough for full approval, they did vote (8-5) that Hemispherx had shown Ampligen was safe enough for ‘marketing’.
What does this mean? It means that most of the panel asserted that, given the needs of this population, Hemispherx had provided enough safety data for the community to be given a shot at the drug.
That’s a huge opening. That’s a prescription for conditional approval with restrictions by the FDA and that was made possible by the huge turnout by the ME/CFS population; a turnout the FDA called overwhelming, a turnout that broke their servers and a turnout that made them very aware of how much this community wants to have access to this drug.
Now, with the FDA in decision-making mode let’s make their decision as a difficult a one as can be. We are a force to be reckoned with. We deserve access to this drug. We know it works. We know every doctor that has used it for the past ten years strongly supports it.
Let’s bring Ampligen home for the ME/CFS Community. Please support this action.
Soo, I emailed. Ms. Sebelius auto-replied immediately, lol. Now that I have the first e-mail sent, the subsequent daily emails will be a snap.
Yah…good. We’re making waves…that in itself is important. We’re constituting ourselves as a group that needs to be listened to..
Deborah,
Thank you for supporting this Action. This is all about the Patients, not the FDA or the Company.
On a seperate Action: Remember to sign the petition Fred set up on ipetitions. We are planning to present a hard copy of the petition to an appropriate official once we have enough signatures.
http://www.ipetitions.com/petition/ampligen/
Bob, can overseas people sign that petition?
Done!
Should we all e-mail every day, you mean? Isn’t there a risk we’ll cross the fine line between effective advocacy and the point where the people we want to influence start viewing our community as annoying spammers?
I’ll e-mail once, I think, and then ask one friend or family member per day. Isn’t it better to get more people in, rather than sending multiple messages from the same address?
Hi, Emma. You have to do what feels right to you.
I, myself, will e-mail everyday. 😉 The idea is to get their attention, to make them understand that surrender is not an option. And that works for me.
And thanks Bob for the link to Fred’s petition. http://www.ipetitions.com/petition/ampligen/ Will sign that , too.
But um, you lost me @ ‘..this is all about the Patients, not the FDA or the Company’ ( ominous sound that with a CAP ‘P’ for patients and ‘C’, for company, lol.) I never mentioned the FDA or the ‘Company’.
Don’t get me involved in any personal disputes, please. Mutters and walks off with my tiny brain in hand.
Deborah,
That was just a general statement not directed at you…
Red face here, Bob. And , oh wow, goodie @ not directed at me!!! Ugh. Cognitively challenged here. Seriously. I live with the consequences of head trauma as well as with CFIDS.
My sincere apologies for ‘being weird’, and too, that you were the unlucky guy that caught my twitchiness.
Ty all, Bob, you and Cort, Bille & Team. I loveee this ‘Action’. Sending an e-mail a day makes me feel useful..for a change.
Hi Cort – great article – minor typo in that 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.
I already sent my email off yesterday and will do so again each day until the decision comes out. I take the point made earlier about wondering if daily emails might be so annoying as to be less effective but we’re clearly not spammers: we’re not selling anything, we’re making a legitimate and, frankly, desperate plea.
I tried to imagine myself on the receiving on of the emails. I think I would be more impressed by the desperation of people emailing daily than once, and more concerned about the political fallout if I failed to meet their wishes.
We each must do what we think is right, though! The clearly wrong thing would be to not act at all.
In addition I have added to the mailing list these 2 important people that could help us:
Nancy-Ann DeParle ,( Assistant to the President Obama and Deputy Chief of Staff)
email contact :info@messages.whitehouse.gov
Dr.Howard K.Koh, ( Assistant Secretary for Health) , email contact :ASH@hhs.gov
way to go guys – i will be emailing everyday too – i also signed petition and will be getting all my family and friends to sign too. i really believe with enough pressure , fda will approve conditionally.
and agree – that 8-5 yes on safety leaves the door open for sure – this is not over !
If we were going to win any vote – that was the one to win..The panel thought the drug was ready for the community…let’s get the FDA to think so, as well.
agree – better to have a safe drug with marginal efficacy then solid efficiacy and not safe – no chance at all with the latter
i should say that was well written email and powerful Cort – good job and good job to the rest of you who are organizing this!
Thanks Kyle! Let’s have the FDA get that its time, after 20 years, for this community to have access to Ampligen! 🙂
I did my own riff on the message:
When the FDA Advisory Committee voted 8-5 that Ampligen was safe enough for marketing approval they sent a clear message to the FDA that they felt it was time to conditionally approve this drug.
Chronic fatigue syndrome is not your ordinary disorder. There are no FDA approved drugs for this disorder. There are no other drugs in the pipeline, no one doing research on drugs and no possibility of a drug for years and years.
Ampligen has been used safely by doctors in this country for the past decade. Every doctor who’s used it has said so and every doctor has endorsed it Yes, Hemispherx needs to do more work on efficacy and safety. Give it the opportunity to do that and more importantly give the ME/CFS community a shot, finally, at a drug that their doctors say works and that we know that works.
Please conditionally approve Ampligen for chronic fatigue syndrome.
I like that – I think I will steal it for my email today! Already sent three over the last three days.
I ripped that too. Thanks!
I’ve written, too, and had a general form email back from one person saying the committee does its best for public safety and needs, blah blah blah and didn’t address the ampligen issue at all. It makes me wonder if they’re reading these.
Pris
I think that’s just a standard autoreply to acknowledge receipt of your email. I get the same one every day I’ve emailed. It doesn’t mean no-one will read it – it’s just standard practice in some offices to send auto-guff on receipt.
I’ve already done this with anothe CFS/ME advocating organization. I’m a US citizen but live overseas.
I just sent my first email thanks to the reminder from Cort. Although I cannot use Ampligen personally, I feel that getting any drug approved is worth this email campaign and anything else we can do. Even just one approved medication for ME/CFS will give this disease a nudge towards legitimacy and maybe spur pharmaceutical companies and other entities to research for more.
Taking this a step further, IF it is approved then any ME/CFS patient should have access to it; however at what cost? Do insurance companies have to cover the cost of ampligen or some portion? Will there be a cap for this drug? I can tell you that Medicare won’t touch it which is probably the main insurer for those on disability. I am just concerned that it will still be out of reach for many because of its prohibitive cost.
Anyway, approval is the goal and I’m thinking way past that.
I think it would take time for everyone who wants access to have access to it. It’ll take more Hemispherx studies to finally prove efficacy and safety. The cost question is a good one…Ampligens cost has dropped over the past year or so but I’m sure its still very expensive. I wonder what cost savings would come from ramped up production…
Have signed the petition and sent the emails. I may have a connection to get something put right on the desk of Sebelius. Please email me if there is something other than the above that you would like for me to try to get right into her hand.
Thanks again to all, especially Cort who is starting off the year with such an awesome blog.
Here’s my latest:
If any community deserves the benefit of the doubt or an extra chance at the FDA it’s the chronic fatigue syndrome community. ME/CFS strikes a million people and receives amongst the lowest funding levels of any disorder at the NIH. It has had one drug in the FDA pipeline for over 20 years. There are no other drugs under development for ME/CFS.
Ampligen has used under restricted conditions by doctors in the US for over 10 years. They all endorse it. They all say it’s safe.
It’s time to give this community and this drug a chance. Please have the FDA conditionally approve Ampligen so that the small company that develops it can continue to test it and so that the ME/CFS community can get the opportunity to access while its being tested.
A no vote probably means Ampligen disappears forever.
Please support Ampligen’s conditional approval at the FDA.
Thanks
Cort Johnson
Agreed. So do you want me to get something hand delivered by staff to Sebelius? I am mostly too ill to be on the computer, so please email me. Thanks for everything.
Hello Everyone,
The 750 emails that gave your personal testimonies and stories were amazing. The FDA was not prepared to get such a response. The numbers overwhelmed them to the point that they made specific comments several times, almost as a plea to say, We hope you’re not mad at us. The patient community did a great job by emailing and telling FDA what it’s like to live with this illness every hour of every day for a life time and we deserve a treatment Now. Anyone who was able to send in an email should feel proud. And those who could not send an email need to know that those 750 emails helped to represent you and we as patients understand why you could not. We are currently sending in about 350 emails daily for the current “Approve Ampligen Now” action, if we could get that up to 500 that would be great. Your Action drives the FDA to Act, it also gives the company Hope to keep pushing ahead. Just as we patients need Hope, so does a company that has supported our community for over 25 years now. Yes, they could have done many things better, but they never walked away from us.
So ask friends and family to help any way they can and keep the emails flowing daily. I promise each one makes a difference. The closer we get to the February 2nd, end date the more emails we need.
Patients=Power
I am humbled by your support and your continued efforts to help change our lack of treatments,
Thank You All,
Bob Miller
hi Bob !!
Your commitment to us is always huge thank you again!!!
Bob do you have any news from Whitehouse about the support that the president Obama could give to our cause?
What about Nancy Ann DeParle and dr.Dr.Howard K.Koh?
thank you Bob
carla rumori
Carla, There is no tit for tat with the White House promise from President Obama to elavate the priority of CFS. It is a constant. Maintaining awareness about CFS. Are they aware of the recent meeting and patients input, Yes.
Bob
Many have voiced their concern about the Medpage piece, I would urge you all to keep sending in your emails Daily to counter David Pittman’s very poor article directed at this patient population. The 350 plus daily emails sends a clear message to FDA. The FDA told us to advocate for ourselves, so lets do it. We are here and we are not going anywhere. We deserve this treatment Now.
http://www.facebook.com/events/121302214705174/
Sell it has a medicinal supplement then it does not need FDA approval.
My sister just informed me that she read in a Florida News Paper that the FDA approved Ampligen. Is this true? She said there is a new research hospital (Nova South East University Hospital) is beginning treatments (FM)under a new area of the hospital called Nuero Immune Medicine. Do you know anything about this? Thanks for getting back to me, Sandy
hi Sandy, Nova is Dr. Klimas’ new university. (I think Dr. Fletcher moved there also? Cort, do you know?) They have set up a new program there and the university is very supportive.
However I have not heard of Ampligen being approved. I’m figure there would be an announcement and it would be all over the stock news if it were. However I’ve been kind of out of it and I could have missed something.
Janelle
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