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Article: Hope for Ampligen-Breaking News!

Discussion in 'Phoenix Rising Articles' started by Phoenix Rising Team, Mar 6, 2011.

  1. Phoenix Rising Team

    Phoenix Rising Team

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  2. Cort

    Cort Phoenix Rising Founder

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    That's great news that there's movement on Ampligen. More doctors means more patients and more data and better chance of Ampligen finally getting approved. It looks like Hemispherx is confident of their product and are will to pump some more money into it!

    That's all good! :D
     
  3. Enid

    Enid Senior Member

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    Another piece of really good news Kelvin - must be pretty certain this "works".
     
  4. Guido den Broeder

    Guido den Broeder *****

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    Hemispherx started their first Ampligen trial in 1988, one year after I became ill. It is now 23 years later and I am still waiting for my first medical treatment. Will it be soon, I wonder.
     
  5. Cort

    Cort Phoenix Rising Founder

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    It's more than past time...particularly after seeing people being brought back from the brink. Everyone should have access to this treatment.
     
  6. Cloud

    Cloud Guest

    Thanks for the news Kelvin. I am wondering if this "widened enrollment" (of the open label AMP 511) will continue as "cost recovery" involvement? If so, that will preclude most of us anyhow. But even if so, it does move us closer to the drug being on market.

    Look forward to your next report.
     
  7. pinkytuscadaro

    pinkytuscadaro

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    Kelvin,
    Do you know how much the cost will be per year for treatment?
    Have you been able to wean off of Ampligen or is it a lifetime treatment?
    Thanks
    Pinky
     
  8. anncavan

    anncavan

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    "The other bit of good news is that the new protocol allow more latitude with certain patient medications, and drug holidays. When I was on the AMP 511 trial last year, we HAD to get our infusions and average of every 3 days, come rain or shine. We also had to completely cease and desist almost every other medication that was helping us, including most antivirals, and immune modulators like Nexavir. The new protocoal they are announcing to physicians this weekend is more liberal- it allows for short "drug holidays" as well as allowing more latitude in certain meds you can stay on while doing the Ampligen trial."

    Hey Kelvin,
    Does this mean Nexavir is allowed? Or did I misunderstand, and you were simply giving that as an example as something that wasn't allowed and probably still isn't allowed?

    Thanks!
     
  9. WillowJ

    WillowJ Senior Member

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    Yes, patients will have to pay for the medicine themselves, which concerns some of the physicians. However if this sort of trial eventually leads to FDA approval, that could make it available with Medicare/insurance coverage.
    I get the feeling Heb isn't big enough to sponsor the trial itself, and I rather wish they would let a bigger company buy them out. I did hear they hired a new direcor, hope that helps.
     
  10. Kelvin Lord

    Kelvin Lord Ampligen Journalist

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    Lannie, although I haven't read the new paragraphs with my own eyes, a couple of the people who were in Florida this past weekend told me that they think Nexavir will STILL be one of the drugs you have to stop to go on the Ampligen trial. Sorry if I poorly communicated that. However there are other meds USED TO BE on the list, that they have apparently now become more liberal with. They tell me that any patient that signs up for the new trial can petition to have a medicine "allowed" - as long as it does not directly compete with the immunomodulation properties of the Ampligen.

    Willow, unfortunately I just now confirmed with a Doctor who was in Florida at the Hemispherx conference this past weekend, that Hemispherx has not committed to doing a "double blind" test--- this would be the kind of placebo trial where the drug company pays for the medicine, but only half the patients get the real drug. Sadly, that news did not come out of this meeting.

    However, Hemispherx did say that they would now be "watching more closely how subjects with XMRV respond to the drug." In a retrospective study they know that XMRV(+) subjects respond better to the drug, suggesting that Ampligen is a real treatment for XMRV.
    If XMRV(+) subjects do respond better, HEB has committed to sponsor a double blind placebo controlled crossover study with a fairly large number of subjects. But that could be months, if not a year away in my view.

    What we are left with from this past weekend's meeting is that Hemispherx has hired a new staff and added personnel to help recruit and train more doctors, that they HAVE indeed added about 5 more clinics to the roster now in other US cities, and that the AMP 511 protocol is more liberal than it was before, allowing some patients who need them to continue on certain medications during the trial, as well as take an Ampligen drug "holiday" for emergencies or situations that warrant it.

    Typical HEB sort of news - you can be hopeful, and these are good signs, but you just wish they'd do more, faster, no?
     
  11. Cort

    Cort Phoenix Rising Founder

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    We all wish everyone would move faster but progress is progress and its good to see Hemispherx moving in the right direction and pumping more money and resources into Ampligen.....that's a great sign indeed that they are confident about the drug.....Can't wait to hear more. :)
     
  12. Evangelina

    Evangelina

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    Is there any collective data available for public viewing?

    "Hemispherx has not committed to doing a "double blind" test--- this would be the kind of placebo trial where the drug company pays for the medicine, but only half the patients get the real drug. Sadly, that news did not come out of this meeting."

    "What we are left with from this past weekend's meeting is that Hemispherx has hired a new staff and added personnel to help recruit and train more doctors, that they HAVE indeed added about 5 more clinics to the roster now in other US cities, and that the AMP 511 protocol is more liberal than it was before, allowing some patients who need them to continue on certain medications during the trial, as well as take an Ampligen drug "holiday" for emergencies or situations that warrant it."

    Kelvin,
    Is there any data available for public viewing that gives numbers of patients who have tried Ampligen and their responses to the drug? Before I let my family mortgage our house and sign me up I would like to know percentages of those helped and to what degree. Also, I have weak veins. Did anyone you talked to (besides Mary S.) have a PICC line installled for Ampligen therapy or something like a permanent IV? I detest ivs...
    Thanks, Evangelina
     
  13. denlander

    denlander

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    The problem with continuous infusion or frequent infusion of Ampligen in the same vein was discussed at the Ampligen Trial Group. The concensus was that Ampligen did not "sclerose" (cause constriction) and could be used in the same veins for long periods. There is of course the problem with patients who have "bad" veins to start with and may require other approaches.
    Derek Enlander MD
    New York
     
  14. Kelvin Lord

    Kelvin Lord Ampligen Journalist

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    Evangelina, RE: making public the number of users of Ampligen and the results- ah, that is the $64,000 question! Unfortunately, the very nature of a "drug trial" precludes us from getting access to this critical, all-important info until AFTER the drug is approved. While Hemixpherx and others have published results of a wide variety of trials and uses for Ampligen (just use Google Scholar to search "Ampligen" to see them all), there has not been made public a total summary of users and results. Before I decided to apply for Ampligen in Jan 2010, I did my own research and was able to connect with at least a dozen former Ampligen patients- some from the very first trial in the early 1990's, and others in ensuing years. My limited research showed me what other Doctors like Lapp and Peterson have said- that for qualified patients, about 70-80% of those who get Ampligen seem to get on average 70% better.

    Also, what Dr. Enlander says about Ampligen being easy on the veins is spot on- I asked Hemispherx about a PICC line and they specifically recommended against it- based on the risk vs. reward, saying that the odds in a year of having PICC line problems are higher than any potential problem with regular infusions of Ampligen. In my experience I would concur. After 1 full year of twice per week infusions, or a total of 104 times Gwen stuck the same veins in my hands over and over again, I never had a problem with it, and the infusions were always pain free.

    I've written about the side-effects on Ampligen in other posts on my blog, but just know that the least of your worries when on the AMP 511 protocol is the tiny little stick of a needle or finding your veins. The bigger issue is, as an RNase upregulator and downregulator, Ampligen makes you feel like you have the flu twice a week, with all the concomitant yuckie feelings that go with it. I never want to forget that part of it - even though now I am doing so much better BECAUSE of the Ampligen. The reality is when you are on it, it is pretty much hell. Hell with hope.
     
  15. heapsreal

    heapsreal iherb 10% discount code OPA989,

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    does anyone know if u could inject ampligen intramuscular, my thinking is to start with infusions for a week or 2 and then if possible move to injections which would be alot more convenient as some could do it themselves or see their local doc for them.

    cheers!!!
     
  16. LaurelW

    LaurelW Senior Member

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    No can do. The drug development hasn't gotten that far. The only way you can get it is through infusions, from glass bottles, from specific doctors that are willing to give it.
     
  17. Freewindblowin

    Freewindblowin

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    I see Ampligen being talked about again-so few lucky people have been treated-and fewer retreated even though re-treatment was promised. It has been around for...is it over 20 years? It does work for many people-

    However, while Hemispherx on occasion pulls together a study now and then, they have refused to make it available as they kept claiming they would for us, all along. When will we be able to get it Hemispherx? For sure this time?

    There are many things to learn about this company. There are many good people trying to get these lifesaving products out.

    However....

    I have been involved with Hemispherx for 10 years. Hemispherx- particularly via Dr. Carter (long background on him-yet he keeps accusing the FDA of harming patients-yet he never files the paperwork needed, and never manages to get the needed tests done--have pulled the rug out from making Ampligen available so many times I cannot believe they have even been permitted one last chance-this year, and time is running out. The Ampligen/FDA process has not been done. It has taken several shareholder lawsuits, and the FDA pushing just to get some movement and a one year reprieve. Carter has lied, kept taking the money and leaving excellent researchers hanging out to dry. And they are leaving.

    I personally set up the trials in 2006 for a local medical clinic in Idaho. I faxed our Ampligen order. After it went though I called to confirm-and the suddenly, to my shock, a now-in-control former secretary for the trial coordinator (the trial coordinator had a nervous breakdown and was forced to leave after she couldn't handle telling everyone that Hemispherx was scuttling everything they had been working on and had promised everyone to have happen for Ampligen (and ALferon-N) access-all of which which we, and who knows how many others also directly dealing with them about) only to be told me that "everything was off the table now." I carefully explained that I must be talking to the wrong person-she insisted I did not. I then re-explained I had the signed documents for trials, signed off on by everyone-and our order had been faxed! She repeated this "everything is off the table now" and added she didn't believe in CFS, by the way, either. I overheard someone call for her from outside the office-she "had to go" she said. they were "doing important telephone calls with other countries" right then.

    I was so thrown-even after I and the doctor called everyone who used to pull some weight in that company-(Those dear people were just as thrown by Carter's coming in and announcing he had "taken everything off the table and was heading elsewhere with the company" that morning.). I was in such shock, I couldn't speak for five days. Everything had been readied, we worked directly with Hemispherx...all the patients, everything-and now we couldn't help them?!!!!!!!!??? Just like that? [I have it myself-and things are not looking good for me at all] Now there is no way anyone in Idaho has been able to get into any one of these studies-which were labeled as being available in every state on the Clinical Trials pages at FDA for years.

    Dr. Peterson couldn't get it either, for years-and he is one of Hemispherx' go-to people, yet they have dragged his attempts to get Ampligen rolling out a long time. Even if you pay for it, you can hardly get lucky enough to get one of the few open label studies. I know people who have been trying for years- think about how, after all it says there on the FDA sites - for years that they are doing it... but no one makes sure Hemispherx are doing what they say.

    Meanwhile a very virulent set of mosquito borne viruses-which Alferon-N can stop in people who come down with them-are now endemic throughout the United States. Another problem the CDC pretends doesn't exist. These diseases have killed many many people, within 0-5 years of getting these disease(s).

    These diseases-including WNV-and many are worse than WNV! are remitting and relapsing, and do extraordinary damage and there is no way you can get insurance once you have had of these-forget trying to get SSI in time or any help-30% of people who get for example, WNV, will never ever recover, and 10% will die within 1-8 years because of the immune system problems, which-guess what-become very much like M.E./C.F.I.D.S. I personally watched several death certificates being filled out over the next 3 1/2 years after 2006. These people have the same problems, the same up regulation issues-brain fog-all of it. I know 80 of them personally.

    Sure, I am working on a book too-but I am sick as a dog, as are many survivors. I have the papers, the history, the emails-Please send me Hilary Johnson. I keep trying to plug along. This is all open source.

    The CDC doesn't receive the reported cases from the states anymore because the states no longer bother because the CDC won't give them money and everyone pretends this isn't happening. In 2006, there were over 23,000 actual cases of WNV in Idaho when Idaho was #1 in the nation for WNV cases. I was present at the meeting where that number was acknowledged-but the health departments only reported 1006. I helped patients, legislators and vector controllers, and two doctors, and many others get the law changed in Idaho to permit Mosquito Abatement Districts to be created easily. My doctor's clinic testified at the first county that moved to make a county wide MADD district. At that same meeting-the health department personnel fought against it-saying it wasn't important! Yes,, I have all the names, all the records, all the recordings. Unbelievable. A nightmare.

    What about Hemispherx. What does any of this have to with AMpligen saving us from CFS.

    Okay.

    A few years later, Hemispherx made new batches of Alferon N. WNV study never finished-Hemispherx didn't tell the world class doctors at Cornell about the fact they had no Alferon-N available for them. Hemispherx never told Cornell it wasn't available-my medical clinic's M.D. had to tell them. By the way-Hemispherx made Alferon-N available only through a company that charges 12 times what it costs them to make.

    These two medicines could save the world-could save the United States and our Military overseas for starters.

    Dr. Carter-very much a circus promoter-conductor abroad, most recently gives Mexico the right to produce and market Ampligen- (as they did other countries-then sued them later and got their "rights of ownership back").

    Hemispherx' stock is at $0.46 right now - where it has been for years. Carter had to pay money back to investors and to stock holders. Dr. Carter did allow Ampligen to be fed to chickens in China. Guess what for-Avian Flu. Important issue, yes?

    Hemispherx gave Ampligen to China for feeding their chickens to grow better and bigger within the close, horrendous conditions they are grown in. Wow. Okay--BUT-the bacteria and viruses the chickens got? The chickens and swine they feed this Ampligen dusted food to-all soon acquired tolerance to the Ampligen. Feeding masses of what is a life saving medicine to chickens and pigs in China on an industrial scale? Talk about setting the stage for a super bacteria/super-virus to take us all out instead of starting it at the end where the people are sick, taking care of them-under controlled situations. Hemispherx has set the stage for an invincible illness.

    Every word I say is true-I can back it up as can many others. Yes, I have written to Sen. Grassley and Rep. Issa as well. Let all of us insist that Congress do the job or get out of the way because there are people who are willing to take care of these important duties.

    I never thought I-a relatively naive liberal New Englander growing up-would see my country and my states and my public health service persons-out to help cover up another big lie-why are they, our government, our elected officials-failing to lift a hand, to do merely the right thing-the money and the hands are there to fix these problems, and it can be done really simply and for less cause than all the lost productivity and health, the loss of so many great minds and breathing living patriots? M.E>, WNV, etc.?

    Has Mr. President done anything for us? For them? Even the Inspector Generals of the FDIC cannot do their jobs because Mr. President is actively instructing Justice Dept. not to let anyone check out anything to do with him, not to investigate crimes against non-persons of colors, and letting, if not encouraging the CDC, NIH, NSF to divide and conquer a once free country that knew the importance of the health of all citizens in order to keep freedom from perishing from this earth.

    I am supporting WPI, helping those who demonstrate and write to the degree I can. May we all keep it up and keep supporting those who do the right thing, and use the cures, find the rest, an apply those. It is all there, just waiting. As ill as we are we have to take our lives from those who want to take them away-never ever give up.
     
  18. Nielk

    Nielk

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    Hi,

    It is really disturbing to hear what happened in 2006 with Hemispherx pulling out the last minute. Was that trial going to be a closed trial or open? If it was a closed trial, I would say that they probably pulled out for lack of money which I hear they have a problem with. If it was an open cost recovery study - I don't get it then because what excuse would they have to pull out.

    The whole history of this company is difficult to understand.

    They were supposed to start this open study in a few locations in the US and I hear that they keep postponing it. Why?
    They are charging a fortune for it and the patients are lining up for it, willing to pay whatever it costs. What's holding them up?

    It's all very confusing. In addition, if they lack funding but, Ampligen is such a great treatment why is it that no big Pharma is interested in buying them out? There are things there that don't add up.
     
  19. Waverunner

    Waverunner Senior Member

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    Thanks for the insight, freewindblowin. I can't help myself but I feel very skeptical towards every positive study or news regarding CFS. Like a child who burnt his fingers on an oven I somehow got conditioned to feel skeptical. We had so many occasions in the past where we had some good news about CFS but none of them lead to anything. We are still in the middle of nowhere. I still hope for the breakthrough but I think that it will catch us by surprise.
     
  20. mojoey

    mojoey Senior Member

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    Just started a public ampligen spreadsheet so that we can better monitor the progress of patients on amp. http://tinyurl.com/3zly3ks This crowdsourcing approach has been very helpful for providing a firsthand perspective at the usefulness of GcMaf for ME/CFS.

    Please fill it out if you have been on amp or are on amp, and please spread the word to any other patients you know that are the same.
     

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