URGENT: Dec 6 Deadline to email the FDA's Ampligen Advisory Committee

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by Cort Johnson

Call to Action for First Drug For ME/CFS: the Ampligen FDA Advisory Hearing

URGENT: ME/CFS Patient "A C T I O N"

A Call To Impact Our (me/cfs) Nation

For All ME/CFS Patients, Families and Friends (U.S. & Non U.S.)

Organizer: Robert Miller, Cort Johnson and TEAM

Contact: 511bobmiller42@gmail.com

For the first time, people with chronic fatigue syndrome have the opportunity to make a difference in getting a drug approved for their disorder. At a public hearing on Dec. 20th an FDA advisory committee will advise whether Ampligen should become the first approved drug for chronic fatigue syndrome. As a part of that process they will review all comments produced by the ME/CFS community that are received by Dec 6th.

Ampligen presents a huge opportunity for the ME/CFS community. Not only has it been in the FDA pipeline for over two decades, it’s been the only drug under review for ME/CFS during that time. There are no other drugs waiting in the wings, no other drug companies developing drugs for this disorder; this is the culmination of decades of hope and the opportunity is large.

History has taught us that once a drug gets approved for a disease, other drugs, legitimacy and research dollars follow.

Let’s make history and get the first drug for ME/CFS approved in its long history by taking "A C T I O N" (A Call To Impact Our (me/cfs) Nation) and letting the FDA Advisory Committee know the urgency you feel for FDA approved drug treatments for this disorder.

Please send in your email by December 6th, and let the Committee know what it is like to live with ME/CFS daily and how needed treatment options are.

Our Advocacy Community will update you when other significant meetings are coming up, including the FDA Stakeholder meeting in the spring and issues dealing with CDC and NIH, but right now we need the Advisory Committee to hear from the patient community on this issue.

This drug is our AZT to the ME/CFS community. If approved we believe it will be just the beginning of treatments to come.

Sample Email Template

Send To Email address: AAC@fda.hhs.gov
Subject line: Treatment for Chronic Fatigue Syndrome - Ampligen

To The Advisory Committee Reviewing Ampligen:

My name is ___________________ I have had CFS for more than ___ years. Before I became ill I had a life that was ______________________. My life since having CFS has been____________________________ . We need treatment. We deserve treatment and the ability to access it. Just like AZT for AIDS or Tysabri for MS or Benlystra for Lupus. We are not second class patients. According to CDC studies, CFS is comparable to MS, late-stage AIDS, Lupus, rheumatoid arthritis, heart disease, end-stage renal disease, COPD and the effects of Chemotherapy. CFS/ME effects every moment of my life. We have seen and heard of patients doing well on Ampligen. Give this community Hope by approving Ampligen. We want our lives back.

Thank you,

Full Name

Address Here

(Please Cc: emails to Robert Miller at: 511bobmiller42@gmail.com)

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Thanks, Cort, Bob, and Mark for posting. This is hugely important!

If the FDA approves Ampligen for the US, then it's a game-changer for patients all over the world. There'll be an effective immune-system drug in use for our disease, which will validate our position that what we have is a genuine immune disorder. We'll be able to petition our governments for Ampligen and other immune drugs, as well as for a serious level of research funding. It will transform the way that the public sees us.

Please email the FDA, wherever in the world you live. Took me seven minutes!

 

OK, someone who has looked into the science (no anecdotes please) tell me: How good is the evidence for Ampligen's effectiveness?

 

OK, someone who has looked into the science (no anecdotes please) tell me: How good is the evidence for Ampligen's effectiveness?

Hi urban - here's Cort's article on it:

http://phoenixrising.me/archives/8819

Good enough for me!

 

In the FDA's Advocacy Webinar in Nov, they said that they need to hear from patient groups on how much risk you are willing to take for the potential benefit. They have been swayed before when patient groups have convinced them that they are quite willing to take on risk, a much greater risk than a healthy person may think that they would.

I made sure to mention that in my email - I said patients have and are comitting suicide, they would be very happy to try a risky drug first. (not that I think Ampligen itself poses much risk)

 

This was a comment by Dr. Van Konynenburg, one of his last, about BG-12, the new MS drug. BG-12 is based on dimethyl fumurate which has been proven effective in psoriasis, in pill form, in Europe as an anti-inflammatory.

It works against oxidative stress and glutathione depletion, a theory long promoted by Dr. VK. Unlike Ampligen, its efficacy and safety have been replicated in several large, high quality trials. In Germany and at the Cleveland Clinic. This is a proven effective drug against a neuroimmune illness. This should be our first choice for off-label treatment.

The evidence given by HB for Ampligen is very weak, and results were not replicated. HB has not explained the pathway in which it modulates the immune system. But I believe Ampligen should be approved, only because this is America, and folks should be free to put in their bodies what they wish. But if people choose to take it, it should be on their dime because it is unproven, and the costs are horrendous.

I would say that there is no question that oxidative stress and glutathione depletion are major factors in ME/CFS, based on published research and our own lab testing.

I think it will be very interesting to see how this drug works out. Up to now, I think the pharmaceutical companies have ignored emphasizing oxidative stress to the docs, because they haven't had drugs that would help with it. Only antioxidants, which aren't patentable and have a much lower rate of return, because of the resulting competition.

One thing I wonder is whether this drug will work when there is a partial methylation cycle block. In theory, I guess that if this drug could raise the glutathione level enough, it would overcome the functional B12 deficiency, and that might overcome the partial methylation cycle block, if there was still enough folate available to the cells.

BG-12 results were publicized.
http://www.nytimes.com/2012/09/20/h...-suppressing-multiple-sclerosis-relapses.html

The two new studies, published online in The New England Journal of Medicine, found that the drug BG-12, developed by Biogen Idec, reduced relapse rates in patients with relapsing M.S. by about 50 percent. The drug also significantly reduced the frequency of new brain lesions often associated with these attacks, and slowed the progression of disease compared with a placebo.

 

This was a comment by Dr. Van Konynenburg, one of his last, about BG-12, the new MS drug. BG-12 is based on dimethyl fumurate which has been proven effective in psoriasis, in pill form, in Europe as an anti-inflammatory.

It works against oxidative stress and glutathione depletion, a theory long promoted by Dr. VK. Unlike Ampligen, its efficacy and safety have been replicated in several large, high quality trials. In Germany and at the Cleveland Clinic. This is a proven effective drug against a neuroimmune illness. This should be our first choice for off-label treatment.

The evidence given by HB for Ampligen is very weak, and results were not replicated. HB has not explained the pathway in which it modulates the immune system. But I believe Ampligen should be approved, only because this is America, and folks should be free to put in their bodies what they wish. But if people choose to take it, it should be on their dime because it is unproven, and the costs are horrendous.

I would say that there is no question that oxidative stress and glutathione depletion are major factors in ME/CFS, based on published research and our own lab testing.

I think it will be very interesting to see how this drug works out. Up to now, I think the pharmaceutical companies have ignored emphasizing oxidative stress to the docs, because they haven't had drugs that would help with it. Only antioxidants, which aren't patentable and have a much lower rate of return, because of the resulting competition.

One thing I wonder is whether this drug will work when there is a partial methylation cycle block. In theory, I guess that if this drug could raise the glutathione level enough, it would overcome the functional B12 deficiency, and that might overcome the partial methylation cycle block, if there was still enough folate available to the cells.

BG-12 results were publicized.
http://www.nytimes.com/2012/09/20/h...-suppressing-multiple-sclerosis-relapses.html

The two new studies, published online in The New England Journal of Medicine, found that the drug BG-12, developed by Biogen Idec, reduced relapse rates in patients with relapsing M.S. by about 50 percent. The drug also significantly reduced the frequency of new brain lesions often associated with these attacks, and slowed the progression of disease compared with a placebo.

Ampligen is the only thing that objectively improved my cognitive function, exercise performance, natural killer cell function, and Rnase-L.

It will be a grave, grave loss to people like me if it is not approved because, as Cort points out, there is simply nothing else out there that is even possibly going to get approved in the next five years.

Ampligen has been shown to work as a toll-like-receptor 3 agonist, and this research was published in a peer-reviewed journal.

BG-12 has never had a clinical trial in ME/CFS, blinded or unblinded. It is worth further study, but many things that work for other neuroimmune diseases don't work for this one. Thirty years of bitter trial and error by patients has shown that!

 

This was a comment by Dr. Van Konynenburg, one of his last, about BG-12, the new MS drug. BG-12 is based on dimethyl fumurate which has been proven effective in psoriasis, in pill form, in Europe as an anti-inflammatory.

It works against oxidative stress and glutathione depletion, a theory long promoted by Dr. VK. Unlike Ampligen, its efficacy and safety have been replicated in several large, high quality trials. In Germany and at the Cleveland Clinic. This is a proven effective drug against a neuroimmune illness. This should be our first choice for off-label treatment.

The evidence given by HB for Ampligen is very weak, and results were not replicated. HB has not explained the pathway in which it modulates the immune system. But I believe Ampligen should be approved, only because this is America, and folks should be free to put in their bodies what they wish. But if people choose to take it, it should be on their dime because it is unproven, and the costs are horrendous.

I would say that there is no question that oxidative stress and glutathione depletion are major factors in ME/CFS, based on published research and our own lab testing.

I think it will be very interesting to see how this drug works out. Up to now, I think the pharmaceutical companies have ignored emphasizing oxidative stress to the docs, because they haven't had drugs that would help with it. Only antioxidants, which aren't patentable and have a much lower rate of return, because of the resulting competition.

One thing I wonder is whether this drug will work when there is a partial methylation cycle block. In theory, I guess that if this drug could raise the glutathione level enough, it would overcome the functional B12 deficiency, and that might overcome the partial methylation cycle block, if there was still enough folate available to the cells.

BG-12 results were publicized.
http://www.nytimes.com/2012/09/20/h...-suppressing-multiple-sclerosis-relapses.html

The two new studies, published online in The New England Journal of Medicine, found that the drug BG-12, developed by Biogen Idec, reduced relapse rates in patients with relapsing M.S. by about 50 percent. The drug also significantly reduced the frequency of new brain lesions often associated with these attacks, and slowed the progression of disease compared with a placebo.

Wow, really interesting. Pls keep us up to date with BG-12. I hadn't heard of it.

 

In the FDA's Advocacy Webinar in Nov, they said that they need to hear from patient groups on how much risk you are willing to take for the potential benefit. They have been swayed before when patient groups have convinced them that they are quite willing to take on risk, a much greater risk than a healthy person may think that they would.

I made sure to mention that in my email - I said patients have and are comitting suicide, they would be very happy to try a risky drug first. (not that I think Ampligen itself poses much risk)

Excellent points. Ampligen approval would be the best thing that's ever happened to us, IMO. Everyone, please, please write in. I wrote in and got. My folks to also and sent out a request to some p w ME I know.

 

Personally I'd also go for BG12.

There's more evidence that I can see for ME/CFS being essentially a neuroinflammatory disease regardless of the trigger.

 

Bumping...

 

"In the End, we will remember not the words of our enemies, but the silence of our friends." Martin Luther King, Jr.

 

"In the End, we will remember not the words of our enemies, but the silence of our friends." Martin Luther King, Jr.

That sent a shiver down my spine!

Last day, everybody - go, go, go!

Such an easy thing to do, such huge benefits for us all!

 

Bumping - if you haven't written yet, please, please do it now!

 

This was a comment by Dr. Van Konynenburg, one of his last, about BG-12, the new MS drug. BG-12 is based on dimethyl fumurate which has been proven effective in psoriasis, in pill form, in Europe as an anti-inflammatory.

It works against oxidative stress and glutathione depletion, a theory long promoted by Dr. VK. Unlike Ampligen, its efficacy and safety have been replicated in several large, high quality trials. In Germany and at the Cleveland Clinic. This is a proven effective drug against a neuroimmune illness. This should be our first choice for off-label treatment.

The evidence given by HB for Ampligen is very weak, and results were not replicated. HB has not explained the pathway in which it modulates the immune system. But I believe Ampligen should be approved, only because this is America, and folks should be free to put in their bodies what they wish. But if people choose to take it, it should be on their dime because it is unproven, and the costs are horrendous.

I agree to a point MishMash.
Ampligen does help some people, though probably it isn't the ultimate treatment that the majority of us will benefit from.
BG-12 might be better than Ampligen, and we should shout to get BG12. BUT that isn't on offer at the moment as far as I am aware. Ampligen is, and I think any drug approved for ME/CFS will be a massive step forward, as the first recognized non-phycological treatment. It doesn't matter that it may not be the best drug treatment. The fact that it is expensive isn't all bad either as it would increase the desire to find a cheaper alternative, and that might actually help drugs like BG-12 get approved.

If BG-12 is on the eve of possible approval in a year or two, but there is a better treatment not far away, we should still shout about BG-12 too, even though chances are, that it wont be the ultimate treatment for the benefit of the majority either.

So, I totally think it is sensible to shout for Ampligen to be aproved, even if you are not a big fan. We would be mad not to really.

 

BG-12 will be ready to be prescribed in January 2013. It's here. There won't be any waiting. The only hassle will be finding a doctor to give it to you off label. The drug has been used for over a hundred years, and it is extremely safe. I'm hoping one of our CFS advocate docs will step in and fill this gap. For once, I could go to one of these docs and come home with something else besides supplements and kind words.

If Ampligen is approved, through our letter writing campaign, it will probably take a year or more to make its way through the red tape at FDA. Who knows when you'll get it. Plus going to which treatment centers? It could be several years. All patients should study all drugs and weigh their options. Choose wisely which ones are most compelling.

 

One from New Zealand.

 

BG-12 will be ready to be prescribed in January 2013. It's here. There won't be any waiting. The only hassle will be finding a doctor to give it to you off label.

Hi MishMash - I think that off-label issue will be a gigantic sticking point for most patients.

Like snowathlete says, getting Ampligen approved is our ticket to a whole new world of legitimacy, research money, other drugs being approved.

Let's by all means talk about BG-12 later - maybe start a fresh thread for it - but Ampligen isn't competing with it. It would be opening the way for it.

 

MishMash

We aren't discussing here the best drug to treat ME/CFS, we are advocating to get the first drug that is "on-label" for ME/CFS approved. This will pave the way for other drugs too.

Sushi

P.S. cross posted with Sasha

 

This is certainly not a zero-sum game. In fact, it's a rising tide with the potential to lift all boats. Well, the seaworthy ones anyway. It's absurd to suggest that the approval of one drug would somehow stand in the way of approval of another drug. Each drug stands or falls on its own merits.

And we have a complicated disease that almost certainly has different subgroups; it's pretty much a guarantee that there will never be one drug equally good for everybody. In fact, I don't think there are ANY diseases for which this is true. Even fairly sucky medications, which have been mostly replaced by newer and better medications, often stay on the market because there are still some situations where the sucky medication is the best option. You need as many tools in the toolbag as possible.