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

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by Sasha



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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Comments

There's also an online petition that Bob Miller is supporting and that already has over 1,500 signatures (including mine, now!) - he's going to print it off and present it to the FDA.

http://www.ipetitions.com/petition/ampligen/

Please sign! Another quick and easy action that could make a huge difference in our lives.
 
Freds, the petition's originator, on the petition thread just posted:

The petition has been getting a lot of response so far. I've been contacted by several advocacy groups and there's a handful of campaigns starting up to promote the petition.​
Robert Miller will personally be handing over the signature list to the appropriate parties in DC and is coordinating with Cort Johnson on how best to proceed.​
It looks like we're gaining traction, but the petition will need an all-out effort to reach the kind of numbers required for media exposure. The ultimate goal would be Congress -- but we need your help!​
Some Twitter and Facebook activity can go a long way. Ask people to retweet your calls to sign the petition. Reply to sceptics that Ampligen was voted safe. Ask your Facebook friends what they would want. You *can* make a difference...​

http://forums.phoenixrising.me/inde...o-ampligen-online-petition.21099/#post-323408
 
Thanks Sasha - done both, e mailed the template letter and signed the petition. Decisions in the US will affect patients all over the world. I want to be able to go to my GP or health board and tell them there is a drug being used to treat M.E/CFS and it is approved by the FDA.

All the best, Justy x
 
Thanks Sasha - done both, e mailed the template letter and signed the petition. Decisions in the US will affect patients all over the world. I want to be able to go to my GP or health board and tell them there is a drug being used to treat M.E/CFS and it is approved by the FDA.
Thanks, justy - and I agree that, wherever we live in the world, we all stand to benefit from Ampligen being approved. It would be a huge boost to our legitimacy. And, like you, I want to be able to go to an NHS immunologist and ask them what they're going to do to treat my immune disease when the FDA has approved an immunomodulatory drug for ME.
 
That petition is rocking up to the 1,600 mark now...
 
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.
 
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.
I agree with everything you say there - and what was great about the last action was that we got to hear the numbers of patients and supporters who wrote to the FDA and it was huge.

Sometimes you write an email and have no clue if anyone else is doing it. This time we do know - people are pushing for Ampligen in HUGE numbers.

If you haven't already emailed the FDA, please do it now.

If you've already emailed, please do it again today.

If you haven't signed the petition, please do it now.
 
It took me less than 5 mintues and pretty much no effort.
Do it!
 
Done. Simple.

Thanks, Cort, for the feedback on participation by ME/CFS community in the previous appeal to the FDA.
 
Just done today's email - took a minute.

Also checked the petition, now over 1,700...
 
Done!
I probably wouldn't take Ampligen myself, but I understand how much this would help others, and with obtaining respect as ME/CFS patients.
 
I had already signed the petition, but didn't know about the email, so thanks for putting this on the home page. I have now sent the email as well.

Even if Ampligen is not the "best" answer, it still will cause more publicity to the illness and we need that badly as most people still don't "get it".

I just spoke to someone today who said, "Oh, yeah, I heard about that illness." I had to explain about the Neuro Endocrine Immune disorder and the cognitive issues (not sure how well I did that....).

But, the more emails they get, the more they will realize there is a whole community of people who are watching and waiting for answers - all over the world.

So, as best as you can, if you can post something, here, please, please, try to sign the petition and send the email. It certainly cannot hurt.... and if it brings more recognition to this "severe and life-threatening" illness, then it has done something....

Thanks,
Karen
 
signed it. I am never convinced petitions make any difference. They ought to - but those who consider themselves in "power" are not going to be in "service" to those they ought to be. But no harm in trying.
 
signed it. I am never convinced petitions make any difference. They ought to - but those who consider themselves in "power" are not going to be in "service" to those they ought to be. But no harm in trying.
Thanks, Shell - normally I'd agree but this one is well-coordinated and backed by major players and will be printed off and presented to the appropriate person if it gets the numbers. It takes less than a minute to do so even if someone's a sceptic, better to do it than not!
 
Bob Miller has asked me to remove Sara_Mabry@casey.senate.gov from the list following guidance from Senator Casey's office and there may be other additions or removals according to response so please keep an eye on this thread. I don't have edit access to the article so changes might be slow to appear there.