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

December 4, 2012

Man with placard

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)

 

35 comments

{ 35 comments… read them below or add one }

Sasha December 4, 2012 at 1:39 pm

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!

urbantravels December 4, 2012 at 2:54 pm

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

Sasha December 4, 2012 at 3:18 pm
urbantravels

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! :)

SpecialK82 December 4, 2012 at 5:59 pm

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)

MishMash December 4, 2012 at 7:43 pm

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.

satoshikasumi December 4, 2012 at 8:10 pm
MishMash

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!

justinreilly December 4, 2012 at 8:10 pm
MishMash

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.

justinreilly December 4, 2012 at 8:15 pm
SpecialK82

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.

Marco December 5, 2012 at 11:07 am

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.

Sasha December 5, 2012 at 3:00 pm

Bumping…

satoshikasumi December 5, 2012 at 6:23 pm

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

Sasha December 6, 2012 at 2:41 am
satoshikasumi

"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!

Sasha December 6, 2012 at 10:11 am

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

snowathlete December 6, 2012 at 10:23 am
MishMash

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.

MishMash December 6, 2012 at 10:35 am

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.

OverTheHills December 6, 2012 at 11:27 am

One from New Zealand.

Sasha December 6, 2012 at 11:46 am
MishMash

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.

Sushi December 6, 2012 at 11:46 am

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

urbantravels December 6, 2012 at 2:33 pm

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.

LaurelW December 6, 2012 at 2:45 pm

Ampligen isn't any more expensive than some rheumatoid arthritis drugs. They key is getting Medicare and other insurances to pay for it.

Cort December 6, 2012 at 2:52 pm

Here's what I sent it:
To: Advisory Committee Reviewing Ampligen

I've had ME/CFS for over 30 years… I tried everything I could. I went to the best doctors I could find and tried everything from antidepressants to thyroid medication to hydrocortizone to immune factors to hydrogen peroxide IV's…none of which, remarkably, made the slightest difference. After 30 years of experimenting my treatment protocol exists of watching my activity levels, eating a good diet and engaging in stress management techniques. That's it! That's the sum total of what the medical community has been to able to offer me for this disorder – when you think about it's essentially nothing.

Throughout this period I have watched federal funding for this disorder decline even as NIH funding levels doubled. Even as government sponsored studies indicated this disorder afflicted from 1-4 million people in the U.S., many of whom become disabled, and cost the US economy tens of billions of dollars a year in economic losses, the federal government has never spent more than an pittance on this disorder. Adjusted for inflation it’s spending less money, just a few million dollars a year, than twenty years ago.

So it's easy to understand why only one drug has been in the FDA pipeline for over a decade and why only one small pharmaceutical company has developed a drug for it. This disorder has always been too messy, too poorly defined, or didn't fit the right model or whatever. As funders threw up their hands, mouthed their platitudes about caring and then walked away, however, they walked away from a million or sick peoplewhose lives had been turned upside down and are like me, without access to any approved treatments.

This long term neglect makes it easy to understand why it's so crucial for this community that this drug be given the chance to prove itself. There aren't any other Ampligen's waiting in the wings for the chronic fatigue syndrome community. There's NOTHING waiting in the wings. Ampligen is ground zero for the treatment hopes of this community and I've known people who've tried everything and found relief nowhere and got it with this drug. This community – the whole community – not just the scattered few who can afford it and live near one of the few doctors who provide it now – the whole community – deserves a chance with this drug.

There's lots of work to do in chronic fatigue syndrome; the definition is poor, the disorder is certainly heterogeneous and subsets await to be uncovered. It’s the kind of messy situation that researchers and you probably abhor but please don't penalize the people with this disorder for the work that hasn't been done yet. If we wait for definitions to get cleared up another generation will spend another 30 years without assistance.

It's hard for us to see any downside to giving Ampligen at least provisional approval. Ampligen has been used by doctors in the US for over a decade without serious side effects and there's enough evidence for efficacy to believe this drug will work.

The potential upside is huge. If Ampligen improves the lives of just 20% of this population that's 200,000 people living more meaningful and healthy lives. Please give Ampligen the opportunity to prove itself and allow Hemispherx to market this drug, recoup its costs and develop the kind of rigorous studies we all want to see. If Ampligen works out then a new horizon in research and treatment will have been created and you will have made a huge difference in the lives of many.

Thanks for your time.

Cort Johnson

Sasha December 6, 2012 at 3:05 pm

Great letter, Cort. Really says it all about the big fat zero currently on offer to patients.

But for those of you who haven't written yet, don't be intimidated :) – just use Bob Miller's template email, it's take you five minutes (took me seven but I went on a bit!).

But do it now! Today's the last day we can email.

gracenote December 6, 2012 at 3:07 pm

My letter is much simpler than Cort's. Robert Miller's template at the beginning of this thread makes it easy to get started. It only took me a few minutes to write this, and I encourage others to give it a try.

To The Advisory Committee Reviewing Ampligen:

Hello. My name is XXX XXXXX. I have not been well for over 30 years. It took ten years before I was finally diagnosed with Chronic Fatigue Syndrome. It took even more years before I found a doctor who would begin to treat some of my many symptoms. Since that time, I have gotten more ill, and today I am mostly homebound and often bedbound.

Before I became ill, I started college planning to become a licensed therapist. I took a few years off to get married and begin a family. And then I got sick. Too sick to work, and too sick to adequately care for my children. My children do not know what it is like to have a healthy mother, and now my grandchildren do not know what it is like to have a grandmother who can be involved in their lives.

During all this time, I have met doctors who did not believe how ill I was. I meant alternative practitioners who thought they could cure me. I tried every form of help I could find from diet, to rest, to supplements, to prescription medications. The reality is, though, there has been nothing adequate to the task.

Ampligen may not help me, especially not after so many years of illness. But if I could find a way to try it, to see if it could reverse some of the damage and help modulate my immune system, I would be ever so grateful.

During these years of being ill, I have had to depend on many government programs just to stay housed and fed. I have managed, with one of the programs, to continue my education and I finally got my degree. If I ever regain even some of my health, I am ready to participate and contribute to society. I look forward to the opportunity to support myself and make a difference in the lives of others.

Please take this request seriously. Millions of patients are suffering worldwide. Thousands are so ill that they remain utterly dependent on caregivers. Hundreds have died while still young. Many cannot endure the hopeless suffering and end their lives. Those of us who have survived, and those who are newly diagnosed, are waiting for our government to take our concerns seriously, and to move forward on this promising drug.

Thank you for your consideration.

XXXX
XXX@XXXXX

Sasha December 6, 2012 at 3:12 pm

That's another really great letter, gracenote!

I only wrote a short para about my personal circumstances, on the principle of just getting it done rather than getting it done great.

If anyone's worried that they'll have to write loads, don't be – just use Bob Miller's template, bung a sentence in about how long you've been ill, and send it off.

But whatever you're going to do, do it nooooooooowwwwwwww!

snowathlete December 6, 2012 at 3:33 pm

OK, seen as though people are sharing…this is what I wrote:

To The Advisory Committee Reviewing Ampligen,

I have had CFS for more than 4 years. Before I became ill my life was normal – I worked hard, loved my job, won awards for my work and I had real promise. I wanted to be an author. I wanted to leave a positive mark on society. I'm someone's son, someones husband, someones father. I could easily be you.

My life since having CFS has been on hold. I'm 31 but in reality my life ended when I was 27. Unless I get better, then you might as well write on my tombstone that I died in 2008, even if you bury me in thirty years time.

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.
I disagree; it's worse, I'd rather take my chances with cancer, and cancer is horrid. At least I would be given treatment and have a chance to live, however slim. With CFS right now, I dont get even that.

I have seen and read of patients doing well on Ampligen, and that's signficant because people try all sorts of things but rarely have improvement. Ampligen works. Give this community hope by approving it. Please give me a chance to have some normality of life. I'd hope to get a lot of my life back, but my dream is to join my wife in taking my daughter to the park – if that was all I got out of it it would be worth it.

Thank you,

I just got an email thanking me for providing a statement. It wasnt an automated reply, so it's nice to know that they read it. We've done our best. Does anyone know when we will know?

Sasha December 6, 2012 at 3:38 pm
snowathlete

OK, seen as though people are sharing…this is what I wrote

Brilliant letter, snowathlete – really powerful.

All these great letters put mine to shame – good job numbers count as well as quality! :)

I don't know when we'll hear, either. Does anyone know?

Sushi December 6, 2012 at 4:01 pm

Ironic that we support each other by "liking" each other's very sad stories–but that is how the software works!

Yes, nice to see that they are acknowledging our emails. I don't think that a tally of the number of cc's that Robert receives will reflect the number of letters sent. Not everyone will have cc'd him.

Sushi

P.S.
Sasha Do you know the cut off time–say in Eastern Standand time?

Sasha December 6, 2012 at 4:20 pm
Sushi

Do you know the cut off time–say in Eastern Standand time?

Sorry, Sushi – I only know what's in Bob Miller's article.

Sasha December 6, 2012 at 4:20 pm
Sushi

Ironic that we support each other by "liking" each other's very sad stories–but that is how the software works!

Yes, the irony of that hit me too!

HTree December 7, 2012 at 1:29 am

Hi Cort, All,
I did a big push for the Aviva contest and unfortunately didn't have energy left for this. Is the 6th the hard deadline? Should I submit today (the 7th)? (is there an FDA URL I can look at for details about this?)
Thanks for your hard work everyone!
Peace
Htree
p.s. also, do we know if these comments are public/posted publicly like the last FDA comments? Thanks.

Sasha December 7, 2012 at 2:06 am
HTree

Hi Cort, All,
I did a big push for the Aviva contest and unfortunately didn't have energy left for this. Is the 6th the hard deadline? Should I submit today (the 7th)? (is there an FDA URL I can look at for details about this?)
Thanks for your hard work everyone!
Peace
Htree
p.s. also, do we know if these comments are public/posted publicly like the last FDA comments? Thanks.

Hi HTree – no idea if it's a hard deadline but it takes 5 minutes, literally, to send an email using Bob's template so you might as well do it! :)

I don't have any info about this other than what's in Bob's email.

HTree December 7, 2012 at 3:13 am

A little late, but done! I hope accepted. Fingers crossed.

urbantravels December 7, 2012 at 9:12 pm

You know, I'd go ahead and do if if you're still moved to do so – I think there is still potential for it to "count" and get read.

Here's what I wrote, sent just before the deadline on the 5th. I think it DOES sound melodramatic despite what I said in the letter. Well, it wouldn't be me if it wasn't at least somewhat pompous:p

To The Advisory Committee Reviewing Ampligen:

I am writing in support of the proposed approval of Ampligen by the FDA.

My name is [urbantravels]. I am just about to turn 44. I suffer from ME/CFS, with the additional diagnosis of severe POTS (Postural Orthostatic Tachycardia Syndrome.) I was very healthy and fit and had no history of serious illness of any kind before autumn 2009, when I fell suddenly ill with flu-like symptoms and overwhelming, debilitating fatigue, muscle pain and weakness, with severe worsening of symptoms following any physical activity. Within a month of first experiencing these symptoms, I was so debilitated I had to resign my job. I had extensive medical testing to rule out other medical conditions and was eventually diagnosed with CFS. I remain severely ill and disabled to this day.

Before the sudden onset of this debilitating disease, I was very healthy and fit. I have an Ivy League degree, and I worked professionally first in publishing, and later changed careers to landscape architecture/urban design. I had completed graduate school and worked in the field for 18 months at the time I fell ill. I was devastated to have my brand-new professional career, which I loved and had worked very hard to achieve, taken away from me so suddenly and completely.

I now have just enough physical capacity to live on my own and take care of my most basic needs, with some assistance such as housecleaning and grocery delivery. As a general rule, I am unable to stand for more than 5 minutes, to walk (very slowly) for more than two blocks, or sit upright for more than 20 minutes. I am mostly homebound, cannot participate in my former career on any level, and can write and use my computer, normally reclining with a laptop, only with very careful rationing of my energy. There are considerable periods of time when the mental confusion called "brain fog" makes it impossible for me to write coherently or read with comprehension.

One of the most shocking experiences for a newly diagnosed CFS patient is learning that there are absolutely no FDA-approved treatments of any kind for this incredibly debilitating and devastating disease. Instead, a CFS patient is confronted with an array of "alternative" treatments and home remedies. In fact, there is often considerable social pressure on a patient to pursue these unproven treatments. I choose to conserve my very limited energy and funds rather than chasing around trying various "alternative" cures, but some tell me that this means I am "cynical" and "not trying hard enough" – even that I "don't want to get well."

It beggars belief that so many should suffer such a severe and life-altering illness, yet have no legitimate, FDA-approved treatments available to them. I do not believe that Ampligen is a perfect medicine, or that it will help all patients. Yet I believe there is ample evidence that at least a subgroup of CFS patients are greatly benefited by this treatment. Getting this medicine approved and out into the market will be only a first step toward providing adequate pharmaceutical options to CFS patients, but it is a vital first step. All CFS patients, not just those who are able to benefit from Ampligen, will be helped by this step being taken – CFS has been a difficult disease to understand, and both response and non-response to this treatment will provide valuable additional clues to the pathology of the disease.

It is also very well-understood by most of us in the patient community that the existence of even one FDA-approved treatment for CFS would help battle the enormous ignorance and prejudice that we face – the perception that CFS is not a "real illness." This alone is certainly not a reason to approve a medication, but it does strengthen the argument that the approval of Ampligen would be an unusually significant first step toward better treatment of the disease.

As far as we know, CFS is not a fatal disease, but it is a life-destroying disease. Many of us call it a "living death." I understand that some concern has been expressed about the safety of the drug, or the willingness of patients to tolerate side effects, even though it does not seem that Ampligen is a particularly dangerous drug. As for side effects, a side effect would have to be very serious indeed to dissuade CFS patients from using a treatment that could help us regain our lives, even partially. I think many of us would accept even a small risk of death. As it is, many CFS patients have committed suicide, because the suffering of this disease is so hard to endure. I do not mean to be melodramatic here, but it is hard to overstate how damaged our quality of life often is.

Thank you for your attention to my comments.

Sasha December 8, 2012 at 1:11 am

Great letter, urban.

LaurelW December 8, 2012 at 7:59 am

Well done, Urban!:D

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