• Welcome to Phoenix Rising!

    Created in 2008, Phoenix Rising is the largest and oldest forum dedicated to furthering the understanding of and finding treatments for complex chronic illnesses such as chronic fatigue syndrome (ME/CFS), fibromyalgia (FM), long COVID, postural orthostatic tachycardia syndrome (POTS), mast cell activation syndrome (MCAS), and allied diseases.

    To become a member, simply click the Register button at the top right.

What does Ampligen's effectiveness tell us in light of the latest research?

Jesse2233

Senior Member
Messages
1,942
Location
Southern California
I'm often surprised there's not more discussion on Ampligen's historical effectivess in light of new research on autoimmunity, microbiome, and hypometabolism.

I understand that Ampligen is

1. Expensive
2. Tied to specific locations
3. Not currently available to new patients
4. Stymied by red tape and poor management
5. Likely needed forever
6. Infused twice a week
7. Most effective on the sudden onset viral subset
8. Prone to unpleasant initial side effects

But besides Rituximab, Valcyte, and IVIG, Ampligen seems to be the only drug that's consistently produced remissions for a subset of patients in both studies and anecdotal accounts.

In fact I can't think of an anecdotal account that I've read (whether on PR, HR, PH, Reddit, or blogs) where the results weren't life changing. The one exception I've seen are stories where allergic reactions during infusions forced people to stop prematurely.

Dr Bateman told me that she's never seen a drug have such a profound effect on a certain subset, and it seems to be Dr Peterson's and Dr Lapp's gold standard treatment. Drs Enlander, Klimas, and De Meirleir have all spoken favorably of it as well (though they no longer use it due to issues with Hemispherx).

Some will likely bring up studies that showed negligle improvement on VO max at the end of treatment. Dr Chia mentioned this to me. I wonder however, if those studies' endpoints came too soon, since many respondents report improvements to physical stamina at the 18-24 month mark (with neurological, sleep, and digestive improvements coming earlier). This progression of symptom improvement would seem to square with the progression of other recovery stories.

Furthermore it's the only drug I know of indicated for use in the severely ill (bedridden).

I could be missing something, and that's why I'm genuinely curious. Why does this drug tend to get ignored in theoretical discussions?

There must be a reason Bob Miller went on a hunger strike for it, and that patients uproot their entire lives and move across the world to access it. And that demonstrated effectiveness can likely tell us something about the etiology of the disease
 
Last edited:

Gingergrrl

Senior Member
Messages
16,171
@Jesse2233 My sense is that there is very little discussion about Ampligen because it really is not available in the U.S. even "off-label" so few people have actually tried it. With the other treatments that you mentioned, there is a chance to try it. I tried Valcyte (did not help me and did not tolerate it even at micro dose), I had great improvement from IVIG, and I hope to try Rituximab in June if all goes well.

But no doctor or facility in the U.S. (that I am aware of) currently prescribes Ampligen so I never really researched it b/c I did not believe it was an option and I assume this is the same for others.

Also, do you know if Ampligen would be relevant in autoimmunity vs. viral issues? I think this may be another reason why people are not pursuing it (if they believe their illness is autoimmune based).

Hoping others will add to this and I am sure there are more reasons.
 

Alvin2

The good news is patients don't die the bad news..
Messages
2,997
The latest research is not published yet (i don't mean this metaphorically speaking).
Once Dr Davis determines the molecule causing the block and especially if we identify its source it should be very helpful in figuring out why a treatment works and may be the basis of developing better or cheaper treatments.
 

dreampop

Senior Member
Messages
296
Ampligen has never been proven to be effective in CFS, which it was why it was never approved. The rest is just conspiracy theories. I've looked at all the studies on it and it doesn't do much for CFS except move the needle on NK cell function, which 100 drugs can do. I'd forget about Ampligen and start looking forward.
 

IreneF

Senior Member
Messages
1,552
Location
San Francisco
Ampligen has never been proven to be effective in CFS, which it was why it was never approved. The rest is just conspiracy theories. I've looked at all the studies on it and it doesn't do much for CFS except move the needle on NK cell function, which 100 drugs can do. I'd forget about Ampligen and start looking forward.
What are those 100 drugs that improve NK cell function, and how come we aren't getting them?
 

Jesse2233

Senior Member
Messages
1,942
Location
Southern California
Ampligen has never been proven to be effective in CFS, which it was why it was never approved. The rest is just conspiracy theories. I've looked at all the studies on it and it doesn't do much for CFS except move the needle on NK cell function, which 100 drugs can do. I'd forget about Ampligen and start looking forward.

Ampligen's come closer than any other drug to FDA approval. I don't think we can really say any drug has been proven (perhaps pending RituxME Phase 3). And I don't think one can ignore Ampligen's compelling anecdotal accounts or its continued use by the field's leading doctors
 

Groggy Doggy

Guest
Messages
1,130
Ampligen's come closer than any other drug to FDA approval. I don't think we can really say any drug has been proven (perhaps pending RituxME Phase 3). And I don't think one can ignore Ampligen's compelling anecdotal accounts or its continued use by the field's leading doctors
What helps one person may not help someone else. It's difficult to prove a drug works without a bio marker. The key is to find out what treatments work for you. You may need multiple treatments and may need to follow a sequential order. No one said the road to recovery is easy. It's trial and error, mostly.
 
Last edited:

jpcv

Senior Member
Messages
386
Location
SE coast, Brazil
I disagree, many patients have used and many have benefited from the drug.
it does have imunomodulatory effects, I reckon it works more as a imunossupressive drug than an antiviral drug.
Thye infusion schedule is troublesome, but I wouldn´t mind going to a infusion center every 2 weeks if it works.
 

jpcv

Senior Member
Messages
386
Location
SE coast, Brazil
I have severe ME/CFS (required to participate in the trial). When I first started Ampligen, I was barely able to care for myself and had to hire drivers to get me to the infusion center. The effects were not immediate but after several months, I started getting better. I function at a much higher level on Ampligen. My labs improved too. Viral infections were under control. My natural killer cell test went from 5 to 70. Ampligen is a good drug in the hands of a bad pharma.
To answer your question, I am doing well for now.
I have severe ME/CFS (required to participate in the trial). When I first started Ampligen, I was barely able to care for myself and had to hire drivers to get me to the infusion center. The effects were not immediate but after several months, I started getting better. I function at a much higher level on Ampligen. My labs improved too. Viral infections were under control. My natural killer cell test went from 5 to 70. Ampligen is a good drug in the hands of a bad pharma.
To answer your question, I am doing well for now.
 

jpcv

Senior Member
Messages
386
Location
SE coast, Brazil
I'm in Australia, @Jill. The trial I was on was run by the Bioclones, a South African company which was producing Ampligen in the early 2000s. Of the four people in my doctor's cohort of the trial, it was successful for 3 and the fourth had an allergic reaction. One person improved and never relapsed (went back to work, normal life) but the other two of us (I had gone back to finish my university degree, she moved out of home and started working) relapsed after the end of the trial.

I have been trying to get it through a company called Emerge Health, which did a deal with Hemispherx to distribute it in Australia and NZ. However, my application to the Australian Special Access Scheme was rejected.So my only option is to somehow get it overseas.

Ampligen has worked for a lot of people. I have some of the testimonials made to the FDA, but they are in Word files, and for some reason I cannot upload them here.
I'm in Australia, @Jill. The trial I was on was run by the Bioclones, a South African company which was producing Ampligen in the early 2000s. Of the four people in my doctor's cohort of the trial, it was successful for 3 and the fourth had an allergic reaction. One person improved and never relapsed (went back to work, normal life) but the other two of us (I had gone back to finish my university degree, she moved out of home and started working) relapsed after the end of the trial.

I have been trying to get it through a company called Emerge Health, which did a deal with Hemispherx to distribute it in Australia and NZ. However, my application to the Australian Special Access Scheme was rejected.So my only option is to somehow get it overseas.

Ampligen has worked for a lot of people. I have some of the testimonials made to the FDA, but they are in Word files, and for some reason I cannot upload them here.
 

Gingergrrl

Senior Member
Messages
16,171
This is something I've wondered about as well. It's traditionally thought of an antiviral because it boosts interferon levels, but perhaps it may have an autoimmune mechanism as well

If you have any way to find this out, I would be very curious what you learn!
 

justy

Donate Advocate Demonstrate
Messages
5,524
Location
U.K
I cant remember where I read it or exactly what they said, but I believe it was going to be allowed to be made available in The Netherlands - I meant to ask KDM about it but forgot.
 

LaurelW

Senior Member
Messages
643
Location
Utah
Ampligen has never been proven to be effective in CFS, which it was why it was never approved. The rest is just conspiracy theories. I've looked at all the studies on it and it doesn't do much for CFS except move the needle on NK cell function, which 100 drugs can do. I'd forget about Ampligen and start looking forward.
Yes, except for the many people, including myself, whose life it completely changed. I agree that good studies are not there yet, but this drug is the difference between being bedbound and being able to have a life for some of us.
 
Messages
39
Location
Melbourne, Australia
I'm often surprised there's not more discussion on Ampligen's historical effectivess in light of new research on autoimmunity, microbiome, and hypometabolism.

I understand that Ampligen is

1. Expensive
2. Tied to specific locations
3. Not currently available to new patients
4. Stymied by red tape and poor management
5. Likely needed forever
6. Infused twice a week
7. Most effective on the sudden onset viral subset
8. Prone to unpleasant initial side effects

But besides Rituximab, Valcyte, and IVIG, Ampligen seems to be the only drug that's consistently produced remissions for a subset of patients in both studies and anecdotal accounts.

In fact I can't think of an anecdotal account that I've read (whether on PR, HR, PH, Reddit, or blogs) where the results weren't life changing. The one exception I've seen are stories where allergic reactions during infusions forced people to stop prematurely.

Dr Bateman told me that she's never seen a drug have such a profound effect on a certain subset, and it seems to be Dr Peterson's and Dr Lapp's gold standard treatment. Drs Enlander, Klimas, and De Meirleir have all spoken favorably of it as well (though they no longer use it due to issues with Hemispherx).

Some will likely bring up studies that showed negligle improvement on VO max at the end of treatment. Dr Chia mentioned this to me. I wonder however, if those studies' endpoints came too soon, since many respondents report improvements to physical stamina at the 18-24 month mark (with neurological, sleep, and digestive improvements coming earlier). This progression of symptom improvement would seem to square with the progression of other recovery stories.

Furthermore it's the only drug I know of indicated for use in the severely ill (bedridden).

I could be missing something, and that's why I'm genuinely curious. Why does this drug tend to get ignored in theoretical discussions?

There must be a reason Bob Miller went on a hunger strike for it, and that patients uproot their entire lives and move across the world to access it. And that demonstrated effectiveness can likely tell us something about the etiology of the disease

Thanks for opening up this discussion @Jesse2233. Given that Ampligen essentially put me into remission while I was on it, I often wonder this. And given that it is such an expensive and difficult-to-obtain drug, I often wonder if there are other drugs that might have similar effect, but that is so difficult to even speculate when so little seems to be known about or is discussed about Ampligen (or Rintatolimod) itself.

Unlike other treatments, you never hear that Ampligen works a bit for someone or makes someone a small percentage better. It seems to be either everything or nothing.

I believe that perhaps one of the reasons there is so little discussion about Ampligen on Phoenix Rising is because the people it has worked for simply don't go on here, because they're getting on with their lives. I certainly would not be here had I stayed on Ampligen 12 years ago. But I don't understand why researchers aren't more interested.

Really get sick of all the ill-informed sceptics on Phoenix Rising as well. I feel like if pwME had seen what Ampligen can do they would be trying to access it to see if it works for them.
 
Messages
39
Location
Melbourne, Australia
This is something I've wondered about as well. It's traditionally thought of an antiviral because it boosts interferon levels, but perhaps it may have an autoimmune mechanism as well

Bioclones, the company that conducted the trial I was on, always told me that Ampligen was an immune modulator and indicated that it would downgrade the immune system if there was autoimmunity.