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

[Jesse2233]

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.

Hey Jeremy good to see you posting on this thread. You were one of the other people I had in mind when I made it. That letter from your doctor describing your turn around is truly amazing.

Did Bioclones, tell you anything else specific in terms of autoimmunity? It's interesting how how many drugs seem to work as both autoimmune and anti-viral treatments

Also, happy birthday!

 

[LaurelW]

Seen your posts @LaurelW, you were one of the many people I had in mind when I wrote this thread.

How long have you been on Ampligen, and what's the improvement been like?

Hi Jesse. I was on it for 5.5 years up until January. I went from a 20 on the KPS scale to 60. Still can't work, have to be horizontal 6-8 hours a day, but can go out and do things 2-4 hours a day. I still have fibro pain, but it's bearable with various pharmaceuticals. Before Ampligen it was unbearable and I was in bed 22 hours a day.

After going off Amp I started taking Imunovir from Canada. It seems to be keeping me from relapsing. It has a similar mechanism--immune modulator/antiviral, but much less powerful. (Fingers crossed)

 

[Jesse2233]

Hi Jesse. I was on it for 5.5 years up until January. I went from a 20 on the KPS scale to 60. Still can't work, have to be horizontal 6-8 hours a day, but can go out and do things 2-4 hours a day. I still have fibro pain, but it's bearable with various pharmaceuticals. Before Ampligen it was unbearable and I was in bed 22 hours a day.

After going off Amp I started taking Imunovir from Canada. It seems to be keeping me from relapsing. It has a similar mechanism--immune modulator/antiviral, but much less powerful. (Fingers crossed)

Interesting thanks for sharing.

Did you go off Ampligen because of the supply interruption? And while you were on it, did you plateau or continue to improve the entire time?

 

[Gingergrrl]

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.

@Jeremy C. I apologize that I do not know your story and was wondering if you have a link or blog where you shared it? Also, did Bioclones explain the mechanism in which it worked for autoimmunity? Does it kill the B-Cells like Rituximab (RTX) or a totally different mechanism? I am asking in good faith and am not a skeptic and truly have never researched Ampligen like I have with RTX. But am now curious to learn more due to Jesse's thread and had always viewed it as an anti-viral vs. something that could eliminate auto-antibodies. Thanks for any info in advance.

 

[Marky90]

Il-informed sceptics Jeremy? I thank god (figuratively) for PR, because skepticism is generally lacking all other places! Individual anecdotes as a general principle should be trusted, but there are all sorts of problems with generalizing from them when it comes to assumed drug effect.

Reason to be skeptical? Ampligen is supposed to help against pathogens, and we don`t have evidence for pathogenic activity in ME/CFS. What we have is subsets who have similar symptoms as if they had an active infection. Or a disturbed immune system. Maybe Ampligen does something unknown with ME/CFS, but they should do another trial. We got every reason to be skeptical.

 

[Jesse2233]

Il-informed sceptics Jeremy? I thank god (figuratively) for PR, because skepticism is generally lacking all other places! Individual anecdotes as a general principle should be trusted, but there are all sorts of problems with generalizing from them when it comes to assumed drug effect.

Reason to be skeptical? Ampligen is supposed to help against pathogens, and we don`t have evidence for pathogenic activity in ME/CFS. What we have is subsets who have similar symptoms as if they had an active infection. Or a disturbed immune system. Maybe Ampligen does something unknown with ME/CFS, but they should do another trial. We got every reason to be skeptical.

Fair points Marky, I think we have a right to be skeptical about every treatment. But given the studies there have been on Ampligen, and the positive stories spanning decades, I think its possible mechanism warrent more discussion

 

[Marky90]

Fair points Marky, I think we have a right to be skeptical about every treatment. But given the studies there have been on Ampligen, and the positive stories spanning decades, I think its possible mechanism warrent more discussion

Certainly, I just pointed out that being skeptical should be looked at as a positive thing.

 

[Jesse2233]

Certainly, I just pointed out that being skeptical should be looked at as a positive thing.

Agreed

 

[Jeremy C.]

Hey Jeremy good to see you posting on this thread. You were one of the other people I had in mind when I made it. That letter from your doctor describing your turn around is truly amazing.

Did Bioclones, tell you anything else specific in terms of autoimmunity? It's interesting how how many drugs seem to work as both autoimmune and anti-viral treatments

Also, happy birthday!

Thanks, Jesse! No, unfortunately Bioclones was very vague and I was so sick when I began I was not in a position to ask questions (my brain fog was so bad I could barely form a sentence). I was just told that it can work with both a suppressed and overactive immune system. I have never really understood how this works, but as you say, a number of anti-viral drugs are also used to treat autoimmune conditions. I really should have asked more about it when it started to work.

I discussed it with Kenny de Meirleir years later. He believed that it was the powerful antiviral properties of Ampligen that had the effect in ME/CFS, but his theory of ME/CFS at the time was that it was a viral infection of the B cells. He may have a different opinion now.

 

[Jeremy C.]

Il-informed sceptics Jeremy? I thank god (figuratively) for PR, because skepticism is generally lacking all other places! Individual anecdotes as a general principle should be trusted, but there are all sorts of problems with generalizing from them when it comes to assumed drug effect.

Reason to be skeptical? Ampligen is supposed to help against pathogens, and we don`t have evidence for pathogenic activity in ME/CFS. What we have is subsets who have similar symptoms as if they had an active infection. Or a disturbed immune system. Maybe Ampligen does something unknown with ME/CFS, but they should do another trial. We got every reason to be skeptical.

I agree @Marky90, but I wasn't making a criticism of scepticism per se. I was using the word sceptic in the vernacular sense. It was a reference to a number of people who post negative comments about Ampligen when all they have done is read the research papers, which are admittedly not all that compelling. But just as they do not prove Ampligen's effectiveness, nor do they prove its ineffectiveness.

Given that I was involved in a trial where 3 out of 4 people recovered to returning to work, study and normal life (two of us were bedridden when the trial started) I worry that these comments put people off pursuing Ampligen and this means that there is no push for further research into Ampligen which may explain why it has such spectacular effects in some.

I don't know the cause of ME. But I am not going to wait until this cause is known before seeking effective treatment. That seems more like cutting off your nose to spite your face than scepticism.

All I want to do is get better: I am not interested in arguing the toss. I'm sure everyone else on this forum feels the same way, so why would I not be telling people about what I have experienced with this drug?

 

[Jeremy C.]

Hi Jesse. I was on it for 5.5 years up until January. I went from a 20 on the KPS scale to 60. Still can't work, have to be horizontal 6-8 hours a day, but can go out and do things 2-4 hours a day. I still have fibro pain, but it's bearable with various pharmaceuticals. Before Ampligen it was unbearable and I was in bed 22 hours a day.

After going off Amp I started taking Imunovir from Canada. It seems to be keeping me from relapsing. It has a similar mechanism--immune modulator/antiviral, but much less powerful. (Fingers crossed)

Are you saying that Imunovir has allowed you to maintain the gains you made on Ampligen, @LaurelW?

When I stopped Ampligen I relapsed, not to the point I was at before treatment (which was completely bedridden), but went from being completely physically active back to being housebound.

 

[Jeremy C.]

@Jeremy C. I apologize that I do not know your story and was wondering if you have a link or blog where you shared it? Also, did Bioclones explain the mechanism in which it worked for autoimmunity? Does it kill the B-Cells like Rituximab (RTX) or a totally different mechanism? I am asking in good faith and am not a skeptic and truly have never researched Ampligen like I have with RTX. But am now curious to learn more due to Jesse's thread and had always viewed it as an anti-viral vs. something that could eliminate auto-antibodies. Thanks for any info in advance.

@Gingergrrl I thought I'd posted my story here, but I can't find it. It is posted on the Facebook group: 'Say YES to Ampligen for ME'. This is what I said there:

'Just thought I would share my experience with Ampligen. I became ill with ME in 1997 and by 1999 was completely bedridden and very sick. I could barely feed myself and had ulcers throughout my gastrointestinal tract, terrible night sweats, temporary paralysis of my limbs and would sometimes wake up with my whole body paralysed, which was very frightening. I could barely digest anything. I couldn't tolerate sound or light. In short, it was a nightmare.

My doctor was very worried about my condition and had told my parents to prepare themselves for the eventuality that I might die if things were not turned around. He also worked very hard to get me on a trial for Ampligen, which I began in 2003. The first six months of the infusions were very hard - just getting me to my doctor's surgery, which was thankfully not far away, was a torment - but at around the six months mark, things started to get better for the first time in nearly six years.

It took me another six months to be able to actually sit up in bed, as my muscles had wasted so much, but from there things seemed to progress rapidly. First, I was able to get around in an electric wheelchair, sitting with no dizziness. Then I started to get out of bed and walk around my room, then I was walking around the house and finally was able to go for short walks around the street. Soon walking was no longer a problem; after not even being able to sit up or lift a full glass of water for such a long time, I was walking around all day. I started driving again, I started reconnecting with old friends - who had all been mystified at why I couldn't see them at all during previous years - and I started going out and enjoying life again. Within two years on the Ampligen, I had re-enrolled at university and was travelling there either by car or public transport two or three times a week, often staying working at the library or attending seminars until late at night. I thought I was cured and on my way to a full recovery.

However, when I had been on the Ampligen for about two and a half years, the trial ended and I relapsed, although I never became anywhere near as bad as I had been before the Ampligen. I believe that the good effects of the Ampligen still persisted for around five years, as until that time I could still push myself, which now I cannot. Had I stayed on the Ampligen, I believe I would have my life back by now, and the fact that I have spent the last ten years trying to go back on it, while seeing my health and ability to do things only decline, to the point that I am now mostly housebound, seems a great unfairness. I know that there is a drug that works for me, that can treat this disease and that can give me my life back. Yet, I cannot access it here in Australia. Likewise, I now hear about people who were as sick as I was when I was at my worst, who may experience the type of remarkable recovery I had on Ampligen, but who are left to needlessly suffer.'

The quote from the letter to my doctor Jesse referred to was from a letter my doctor wrote to the Australian TGA as part of my application to be administered Ampligen on the Special Access Scheme. As part of this I was able to get hold of the nurses' notes from my Ampligen trial. This is my doctors' summary of them in the letter:

As can be seen, the Ampligen initially worsened symptoms such as pain and neuroimmune exhaustion (there was also anaemia, but this was not a result of the infusions) before improvements started at around the twelve-week mark. There was subsequent improvement in energy levels and neurocognitive symptoms (eg. ability to hold a conversation) and the patient began walking. Sleep also improved (week 20). At week 23 the patient was able to sit outside in the sun; at week 27 he was able to travel to the clinic without the aid of a wheelchair; at week 28 he was doing isometric exercises and light weights. He reported that he was able to have more social interaction with family and friends at week 49 and to go out to dinner at week 54. He started to keep normal sleeping hours at week 60, reported vacuuming at week 77, driving and shopping (week 78) and found he could tolerate alcohol (week 89). By week 90 he was able to walk to the end of his street and also travelled into Melbourne University to enquire about finishing his degree. Between week 94 and week 100, the patient moved out of home. By week 102, he was cooking for himself, shopping and doing his own laundry and travelling into university

Unfortunately, as I have mentioned, Bioclones did not give me any detailed explanation as to how Ampligen works in autoimmune disease apart from that it can downgrade an overactive immune system. In my case, it certainly brought my RNase L figures back to normal. Mine were extremely high before the Ampligen treatment: I can't recall what they were unfortunately. I don't know whether autoimmune activity can cause high RNase L activity, but if it was that rather than an active infection, maybe...?

 

[Marky90]

I agree @Marky90, but I wasn't making a criticism of scepticism per se. I was using the word sceptic in the vernacular sense. It was a reference to a number of people who post negative comments about Ampligen when all they have done is read the research papers, which are admittedly not all that compelling. But just as they do not prove Ampligen's effectiveness, nor do they prove its ineffectiveness.

Given that I was involved in a trial where 3 out of 4 people recovered to returning to work, study and normal life (two of us were bedridden when the trial started) I worry that these comments put people off pursuing Ampligen and this means that there is no push for further research into Ampligen which may explain why it has such spectacular effects in some.

I don't know the cause of ME. But I am not going to wait until this cause is known before seeking effective treatment. That seems more like cutting off your nose to spite your face than scepticism.

All I want to do is get better: I am not interested in arguing the toss. I'm sure everyone else on this forum feels the same way, so why would I not be telling people about what I have experienced with this drug?

Gottcha, in that case we agree
I`m not waiting around either, I did go for ritux. And would try Ampligen also!

Do you know whats going on with Ampligen now btw? Is it completely off in America? And do you know if anyone has received it in Argentina?

 

[Alvin2]

I didn't know much about Ampligen beyond its Wikipedia article until this thread.
@Janet Dafoe (Rose49) Does Dr Davis know about it and might it be worth trying for Whitney?

 

[Gingergrrl]

Wow @Jeremy C. Thank you for sharing your incredible story! I wish you still had access to Ampligen and it had not been cut off. In my case I suspect that Rituximab is the right path for me vs. Ampligen but I am still very interested in learning more about the mechanism that it may work in autoimmunity.

 

[Jeremy C.]

Gottcha, in that case we agree
I`m not waiting around either, I did go for ritux. And would try Ampligen also!

Do you know whats going on with Ampligen now btw? Is it completely off in America? And do you know if anyone has received it in Argentina?

Apologies, @Marky90, my brain fog managed to make me completely forget your experience with Rituximab! You have every right to be sceptical about treatments, given your experience, and there has been far more research into Rituximab. I personally would be wary of just about everything if I'd tried a drug like that and it hadn't worked. The same for Ampligen: the person for whom it had didn't work on our trial had an allergic reaction to it and as well as that making her worse I think it really put her off any new treatments.

As for the Ampligen situation at present, things seem worse than ever! Hemispherx is not taking new patients for the US trials: so yes, completely off for new patients there.

No-one can seem to get any news from Argentina, but it seems that they will be manufacturing their own Ampligen (as Bioclones, the South African company that ran my trial did). I am hoping it will be cheaper than the Hemispherx product.

It is available though not approved in Europe, but it seems no doctor will prescribe it. There was one in France who was going to open a clinic administering Ampligen, but apparently the French government came down hard on him and scared him off.

I have been struggling to get it here in Australia on our Special Access Scheme which allows doctors to prescribe unapproved drugs. Two people that I know of, including myself, have applied and both applications have been rejected.

So nothing good, I'm afraid. I'm just hoping some good news comes from Argentina.

 

[Jeremy C.]

I didn't know much about Ampligen beyond its Wikipedia article until this thread.
@Janet Dafoe (Rose49) Does Dr Davis know about it and might it worth trying for Whitney?

From what I know about Whitney's situation, it seems exactly like mine before Ampligen.

 

[Gingergrrl]

Do you know whats going on with Ampligen now btw? Is it completely off in America? And do you know if anyone has received it in Argentina?

As far as I know it is not available in the US and I do not know of anyone who has been able to try it in Argentina. But please someone correct me if I am wrong which is very possible! I have spent MONTHS researching IVIG and RTX but have not done any research on Ampligen b/c it seemed like a dead-end and not a drug for autoimmunity.

Edit: Apologies that I cross posted w/Jeremy!

 

[halcyon]

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

In reading about Russian immune modulators, I came across a drug called ridostin. While I don't know how similar it is to rintatolimod or poly:IC chemically, it sounds like basically the same idea, sodium salts of dsRNA that will trigger interferon release. It's an injectable. Unfortunately I haven't come across any Russian online pharmacies that seem to carry it, though I haven't looked super hard.

 

[jpcv]

Review of the mechanism of action:
https://www.ncbi.nlm.nih.gov/pubmed/27045557