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URGENT: Email the FDA about Ampligen now and daily – final decision is imminent

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by Sasha

Ampligen-cfs-clock-ticking.jpg


The FDA will announce its final decision on Ampligen some time around 2 February but could make the decision much earlier.[/caption]
"There comes a point in human suffering when acceptable risk is most appropriately determined for oneself, not by government."

So said Suzy, in an online comment about the failure of the FDA Advisory Committee on Ampligen to vote in a manner that would have got approval for the drug’s use for patients with ME/CFS.

But it’s not too late. The FDA will announce its final decision on Ampligen some time around 2 February but could make the decision much earlier. So we have to act now to have a chance of getting Ampligen approved.

Cort Johnson and Bob Miller have put out a call for patients, families and friends to email the FDA, now and every day until we hear the final decision, to apply pressure to get Ampligen for patients.

There is still room for hope. The panel voted that Ampligen’s safety profile was adequate for approval. The vote on whether Ampligen’s safety and efficacy data supported approval went 8 to 5 against: two votes the other way would have made it 7 to 6 in favour.

We have to push, push now, push hard and keep pushing. Bob and team have produced a template email for us to use, reproduced below, which makes this an easy action. 750 of us emailed the FDA last time: let’s do it again. Please email, and do it now.

Would we like to have better data on Ampligen at this stage? Of course. But it’s an imperfect world and this is our chance. Having Ampligen approved would put the decision about risk and benefit in the hands of you, the patient. And it would validate ME/CFS as an immune disease - the knock-on benefits of that would be enormous, way beyond Ampligen itself.

To close with the rest of Suzy’s post:

"There comes a time when being alive does not equal living a life. Numerous cancer patients willingly suffer side effects of chemotherapy and radiation for a chance to live. CFIDS patients have been given a different kind of life sentence but are also fighting for their lives — give us a chance."

Template email

Click here to create your email automatically from the template, and copy in the suggested text below, or write your own message.

The addressees (already in the template) are:

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

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: PLACE YOUR 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.




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I wrote a great letter to the FDA, I've been writing for all the campaigns that seam good to me. But, I have to say, I was completely deflated to see that only 750 people total wrote in. No wonder there is not much interest in this disease. Oh my, so sad.
 
I wrote a great letter to the FDA, I've been writing for all the campaigns that seam good to me. But, I have to say, I was completely deflated to see that only 750 people total wrote in. No wonder there is not much interest in this disease. Oh my, so sad.

Hi Mouse girl - great that you've written and that you write in all these good campaigns.

The FDA saw the 750 people who wrote in as impressive, though. Relative to the response they normally get, it must have been big.

On research1st's account of the FDA meeting, it says, '[The FDA rep] emphasized FDA’s recognition of CFS as a serious disease with no approved therapies and acknowledged the strong public interest in the day’s topic as evidenced by written testimony submitted to the record by more than 700 people.'

http://www.research1st.com/2012/12/27/fda-panel-votes/

Live from the meeting, Cort tweeted: 'FDA states they were delighted and OVERWHELMED by patient response.'

http://forums.phoenixrising.me/inde...fate-in-live-webcast.20963/page-2#post-319208

That was certainly my impression - it wasn't just what that FDA rep said but how she said it - she seemed amazed (before my connection dropped out because we were present in such numbers that we stuffed up their servers).
 
I wrote a great letter to the FDA, I've been writing for all the campaigns that seam good to me. But, I have to say, I was completely deflated to see that only 750 people total wrote in. No wonder there is not much interest in this disease. Oh my, so sad.

Interesting. To me, it seemed like a powerful response from a group of very ill patients.
 
Everyone, The 750 emails that gave your personal testimonies 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 angry with us. Patients did a great job by emailing and telling FDA what it's like to live with this illness every day and that we deserve a treatment. Anyone who was able to send 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 emails daily that would be great. So again as a seperate action from the petition, ask friends and family to help any way they can and keep the emails flowing daily.

I am humbled by your support and your actions to help change our lack of treatments,
Thank you,

Bob Miller
 
That's really good to hear about the FDA's reaction, Bob - yes, let's get those emails boosted!

350 is great but 500 would be greater so if you haven't been emailing, please start now!
 
Just sent today's email and checked the petition - over 2,100 signatures now.

If you haven't emailed or signed the petition, please do so now and keep emailing every day. This is a huge chance for us!
 
Just sent today's email.

The petition is at all the twos - 2,222 - maybe that's lucky!

If you haven't emailed yet, please do so now and keep doing it every day until we get a decision. Any day now!
 
Just did today's email. Let's keep on trucking!

Freds, the sponsor of the online petition, wrote this on the main petition thread (if you haven't already signed the petition, please do so - it takes seconds and it's here - http://www.ipetitions.com/petition/ampligen/

We did well so far, but the sign-on rate has dropped in recent days.

I'd like to appeal to the community.

If you have an account on other boards or communities, it would be greatly appreciated if you could post about the petition there. If you're on Twitter or know someone with a large following, that kind of exposure is invaluable. The same goes, of course, for other Facebooks, printed press, etc. This includes audiences unrelated to ME/CFS.

An FDA "no" to Ampligen would significantly slow down investment in chronic diseases in general. They voted it safe. They're not contesting its effectiveness per se, they mainly insist on knowing which subset is affected more than others. We're not saying this doesn't belong in an efficacy profile, we're saying its added benefit doesn't outweigh the tremendous human and financial cost. It's an insufficient justification for keeping a potentially life-saving drug from bed-ridden patients with no alternative. Authorities in Canada and Brussels approved it 2 decades ago. Do you really think they're less diligent? Respect our right to decide with our doctors and provide incentive for sponsors to give drug companies the means to get those subsets refined.

We already know the subset that matters most. They're called ME/CFS patients.

Thanks for your support!​
 
I don't get it. Why are people sending it duplicate (or daily?) emails? Surely each name will only be counted once. And what about those marked 'anonymous', with no message? Do you think they'll be taken seriously?

I don't get it.

???