Update on Ampligen Availability in the US

[Gingergrrl]

It does seem insane that there is a drug that works for me and I can't get it, even when I am willing to pay.

This is maddening to hear and I hope that some how you will be able to get Ampligen again. It is completely insane that you are willing to pay for it but cannot get it.

What is the mechanism of Ampligen compared to Rituximab (RTX)? Is Ampligen more similar to an anti-viral (in IV form) vs. depleting the B-Cells and autoantibodies?

 

[Jeremy C.]

This is maddening to hear and I hope that some how you will be able to get Ampligen again. It is completely insane that you are willing to pay for it but cannot get it.

What is the mechanism of Ampligen compared to Rituximab (RTX)? Is Ampligen more similar to an anti-viral (in IV form) vs. depleting the B-Cells and autoantibodies?

Yes, Ampligen is an double stranded RNA immune modulator and antiviral and also makes the body create interferon, though no-one seems to know exactly why it works for ME/CFS. But pretty much the opposite to Rituximab.

 

[Jeremy C.]

hey folks... is there actually any evidence that ampligen works after all? how does it work? any insight or source where I can read about it?

 

[Jeremy C.]

hey folks... is there actually any evidence that ampligen works after all? how does it work? any insight or source where I can read about it?

I have other files, but cannot upload them here.

 

[Jesse2233]

@Jeremy C. unfortunately MyTomorrows had no doctors listed. I went about contacting various doctors in Europe who treat ME/CFS. None of them used or had ever used Ampligen except KDM, and he can no longer get it due to the aforementioned supply issues.

Additionally I contacted a rheumatologist in Argentina who gave me the name of the product manager there. If you'd like I can PM it to you.

However I also contacted Hemispherx and they said the drug is not available in the US or Argentina. Finally I spoke with the Dr Bateman and a researcher at Simmeron, and despite their generous efforts, nether were able to help.

When you recovered was it a global resolution of symptoms? Were you able to vigorusoly excecise? And was the same true for the other patients?

I wonder when the patent will expire

 

[Kati]

@Jeremy C. unfortunately MyTomorrows had no doctors listed. I went about contacting various doctors in Europe who treat ME/CFS. None of them used or had ever used Ampligen except KDM, and he can no longer get it due to the aforementioned supply issues.

Additionally I contacted a rheumatologist in Argentina who gave me the name of the product manager there. If you'd like I can PM it to you.

However I also contacted Hemispherx and they said the drug is not available in the US or Argentina. Finally I spoke with the Dr Bateman and a researcher at Simmeron, and despite their generous efforts, nether were able to help.

When you recovered was it a global resolution of symptoms? Were you able to vigorusoly excecise? And was the same true for the other patients?

I wonder when the patent will expire

The drug is not FDA-approved for use in the US. It has been made available in the past from clinical trial, if one is lucky enough to be eligible AND have sufficient funds to afford the drug, the infusions, the physician and to move close to the infusion centers. Seemingly, no one is able to get it unless the patients managed to purchase enough supply for themselves before production stopped.

 

[jpcv]

It's been tested against pancreatic cancer só I don't know If the Company is focusing on other diseases/indications.

 

[Jeremy C.]

@Jeremy C. unfortunately MyTomorrows had no doctors listed. I went about contacting various doctors in Europe who treat ME/CFS. None of them used or had ever used Ampligen except KDM, and he can no longer get it due to the aforementioned supply issues.

Additionally I contacted a rheumatologist in Argentina who gave me the name of the product manager there. If you'd like I can PM it to you.

However I also contacted Hemispherx and they said the drug is not available in the US or Argentina. Finally I spoke with the Dr Bateman and a researcher at Simmeron, and despite their generous efforts, nether were able to help.

When you recovered was it a global resolution of symptoms? Were you able to vigorusoly excecise? And was the same true for the other patients?

I wonder when the patent will expire

@Jesse2233 If you could PM me the name of the product manager in Argentina, that would be great! There are several people I know of trying to access Ampligen around the world and it would be great if we could share our information.

I thought KDM stopped using Ampligen. As I understand it, the supply issues were resolved and they are sending it to Europe, or planned to send it to Europe, but maybe I am wrong. I know that there was a French doctor who was planning to use it, but he had problems with French government regulations. Patients at Lapp and Peterson's clinics have it again, but they now have to pay the new price, which is about three times the old price.

Yes, there was a global resolution of symptoms. I was able to vigorously exercise, lift heavy weights, walk all day. Also improvement of neurocognitive symptoms, gut symptoms, sensitivities disappeared...Of the four people on the trial, two other patients had a similar improvement. One girl, who had been bedridden for years like me, left home, got a job and I know went out partying a lot. I'm not sure whether she was actively exercising, but she was really doing a lot. The other woman who improved basically returned to her normal pre-CFS life. The person who didn't respond to the Ampligen had an allergic reaction to it.

Here is an extract from my doctor's letter to the Australian TGA. Keep in mind that I had been completely bedridden and requiring 24 hour nursing before the Ampligen trial:

'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. After week 124, the patient was gradually ‘weaned off’ the Ampligen from twice-weekly infusions to once weekly to once fortnightly at the advice of Dr D. (see attachment: L.-D. emails re Ampligen for Jeremy Chambers_Jan2005).'


The patent expired years ago! As I understand it, Hemispherx keeps updating their patent by making minor improvements to the drug, but basically anyone can make Rintatolimod. Just no-one is interested. I have wondered about contacting an Indian pharmaceutical company and seeing if they would consider making it, but I don't know whether there is going to be enough profit in it for anyone to do this.

 

[Jeremy C.]

It's been tested against pancreatic cancer só I don't know If the Company is focusing on other diseases/indications.

As far as I know, the company is still trying to get FDA approval for treatment of ME/CFS and similar approval around the world.

 

[Jesse2233]

If you could PM me the name of the product manager in Argentina, that would be great!

Just messaged you

Did the effects of Ampligen still last when you were at an injection every 14 days?

 

[Jeremy C.]

Just messaged you

Did the effects of Ampligen still last when you were at an injection every 14 days?

Not that well. I was already starting to struggle then. Not completely relapsed, but not feeling as well as I had been on two infusions a week.

 

[Jesse2233]

Not that well. I was already starting to struggle then. Not completely relapsed, but not feeling as well as I had been on two infusions a week.

Ah I see. Why did your doctor decrease the number?

 

[Jeremy C.]

Ah I see. Why did your doctor decrease the number?

This was the advice of Bioclones, the company conducting the trial. It was just trying to wean me off the drug after I stopped it altogether.

 

[lauluce]

thanks! i just wish some doctor here in Argentina wanted to read this... but that's never going to happen, I've just accepted it. Sometimes you just have to accept reality and move on... I'm so sad

 

[jpcv]

thanks! i just wish some doctor here in Argentina wanted to read this... but that's never going to happen, I've just accepted it. Sometimes you just have to accept reality and move on... I'm so sad

So you basically saying you have the drug avaible in Argentina but no doctors who are trained to treat this disease?
From the information here , I understand that the drug is produced in Argentina but it´s not avaible, is it right?

 

[JohnnyD]

Lots of misinformation here. From the SEC filings and press releases:

Hemispherx did have manufacturing problems, they have now been solved. They have a primary and a secondary contract manufacturers and they are both manufacturing on an accelerated basis. They are located in Washington State and Southern California.

The price has recently gone up 167%

Ampligen is available in the U.S. - but only to existing AMP511 trial participants. No new patients, however Hemispherx continues to seek approval in the U.S.

The push seems to be to deliver to Europe through MyTomorrows which is based in Denmark and handles Early Access Programs. MyTomorrows has signed up/approved 50 pancreatic cancer patients to receive ampligen. There is an Early Access Program for CFS.

Argentina is the first country to approve Ampligen. However, much work to be done, from the most recent 10-K:

"There are a number of actions that must occur before we could be able to commence commercial sales in Argentina. Commercialization in Argentina will require, among other things, an appropriate reimbursement level, appropriate marketing strategies, completion of manufacturing preparations for launch (including possible requirements for approval of final manufacturing),....."

Hope that helps.

 

[lauluce]

So you basically saying you have the drug avaible in Argentina but no doctors who are trained to treat this disease?
From the information here , I understand that the drug is produced in Argentina but it´s not avaible, is it right?

There isn't a single doctor in Argentina, not even in our capital (Buenos Aires, 3 MILLION inhabitants, 13 MILLION counting Greater Buenos Aires) who knows what CFS/ME is. They don't know a single diagnosis criteria, they just believe there is a disease called "chronic fatigue" or "chronic fatigue syndrome" whose only requisite for suffering it is having some sort of tiredness that can't be explained by common diseases, and that there is no treatment for it, that's all. None of them is willing to do even the most basic research about the disease, it's diagnosis or treatment. They don't even want to read a single page of text about it, and of course most can't, as they don't care about learning english. Knowing my country, I can say to everyone here that probably there isn't ever going to be any doctor in Argentina who con diagnose or treat ME/CFS and due to their mediocrity and enormous arrogance, it isn't even possible to ask them to educate themselves about it, even if giving them the required information, translated to spanish or not (believe me, I tried!). If anybody here is hoping to travel to Argentina now or even in a decade to be prescribed Ampligen by a local doctor, I'm afraid that's never going to happen. It's better knowing it beforehand that painfully finding it out once arriving in this country. I feel so sad and hopeless... be thankful you live in more developed countries, despite all the hardships you face regarding ME, you could be a lot worse, like me

 

[jpcv]

Caro hermano argentino, I live in Brazil, and face similar problems, but I have the advantage of being a physician, even so it took me a long time for me to get bthings together.
I find what you wrote above weird, there are good doctors in Argentina, at least in the Oncology /Hematology area.

 

[Kati]

Caro hermano argentino, I live in Brazil, and face similar problems, but I have the advantage of being a physician, even so it took me a long time for me to get bthings together.
I find what you wrote above weird, there are good doctors in Argentina, at least in the Oncology /Hematology area.

Hello @jpcv while i cannot speak for @lauluce, i can say that millions of patients with ME from around the world encounter stigma, contempt, and neglect in health care and in society.

I have no doubt there are good doctors in hemato/oncology, and other medical specialties that are well established because the diseases they serve are well funded and well researched.

By being a physician yourself, you are more credible from the point of view of other physicians than the rest of us. The doctors you see will bend backwards for you (performing special tests, offer off-label treatments, special treatments, etc). Please consider that a large fraction of us is barely getting respect in health care because we have this disease.

 

[lauluce]

Caro hermano argentino, I live in Brazil, and face similar problems, but I have the advantage of being a physician, even so it took me a long time for me to get bthings together.
I find what you wrote above weird, there are good doctors in Argentina, at least in the Oncology /Hematology area.

that might be true, the´re good doctors in many areas on Argentina, in the areas you describe, cardiological surgery, etc, but regarding ME, I'm afraid I'm speaking the truth