AMPLIGEN-Approval pushed

Discussion in 'Fibromyalgia Main Forum' started by ulala, Mar 7, 2009.

  1. ulala

    ulala New Member

    back to May 25, 2009. This has probably already been posted but I 'm posting it again.

    What other drugs are immuno--modulators? I think ladybugmandy posted the name of one that's not available in the U.S. I'll have to look for the name of that drug. Thanks!

    Approval Changed to May 25, 2009

    As I reported earlier, a decision was expected from the FDA on Ampligen February 25, 2009. But now that date has changed, according to a press release by Hemispherx, the biotech firm that manufactures Ampligen. The drug's decision date has been pushed back to May 25, 2009. The press release attributed the change in dates to a need by the panel to look at "additional data".

    Ampligen could change the landscape for CFS treatment and care significantly. According to the drug's manufacturer, Hemispherx, phase III trials for Ampligen produced marked improvement in people with CFS. Ampligen is an immuno--modulator class of drugs. The FDA decision on Ampligen will come on the heels of a victory in court for Hemispherx regarding information disseminated by short-sellers of their stock.

    As always, best wishes for 2009,

    Craig Maupin

  2. TeaBisqit

    TeaBisqit Member

    How long can they keep pushing this back? I've been waiting eighteen years for this to get approved. Whether it actually works or not, just getting it approved will change the world. Releasing an immunomodulator for this disease will give us the validation we need.
  3. spacee

    spacee Member

    I think it scares the FDA. Big lawsuits and bad press. I would love to have the validation but hate to have people made worse.

    There was a time when I was expected to not live (t-cell count of 185) and I would have gone on it in a heartbeat but I came through that and now I would not take it.

    The woman who was in a wheelchair and saw 114 docs, took the ampligen. She wrote a letter about how bad she thought the ampligen was and it was put on this board awhile back. She said that her husband was her "caregiver". Her name is now on the Memorial List of the deceased. V. Sad.

    Just my thoughts.

  4. TeaBisqit

    TeaBisqit Member

    When I first got sick, I would have gladly injected the stuff into my veins myself, if it would have helped. But all these years later, I'd like to wait and see and know alot more about what this drug does.
  5. ladybugmandy

    ladybugmandy Member

    i heard that if you have been sick many years, you have to take the ampligen for just as long as people are taking the other antimicrobials...i guess the benefit of ampligen is that it acts as a wide spectrum antiviral.
  6. spacee

    spacee Member

    I think I felt the same way in the 1990's.

    In fact, I kept seeing this Infectious Disease doc, even though he wasn't doing anything for me, so that if Ampligen was approved, I could get it. Brought back that memory. Don't see him anymore.

    [This Message was Edited on 03/08/2009]
  7. SpecialK82

    SpecialK82 New Member

    Hi spacee - I had done a little research on Ampligen awhile back but never found out that people had died using it. Is that something that they have attributed directly to the Ampligen? I am really surprised.

    I know others have alluded to bad side effects being reported in the studies - can you point me to some reading where I can learn more? I have tried searching this site and a few others and have googled it - and haven't seen it. Much appreciated if you have the energy.

    I really had my hopes up for this drug - either that it would help lots of people, or that it would encourage more R & D from Big Pharma, or at the very least, shed light on this DD as being real.

    Thanks, Kristina
    [This Message was Edited on 03/08/2009]
  8. SpecialK82

    SpecialK82 New Member

    "What other drugs are immuno--modulators?"

    ulala - zadaxin is another immune modulator, check out the link below posted by quamijay on 3/2/09. Apparently Kenny de Mierlier is using it.

    [This Message was Edited on 03/08/2009]
  9. spacee

    spacee Member

    I was looking at the NCF Memorial (just google) and found 9 people that had been on the Ampligen. A couple of them developed breast cancer soon after and died from that, others died from various forms of cancer (lung, lymphoma). Some didn't live long and other died within the last few years.

    It is difficult to get an accurate feeling except that the patient I mentioned earlier "would talk to anyone who had questions about Ampligen. She felt that Ampligen caused more problems than it helped".

    Other than that, I don't know of any source. I do believe that only the very sick were allowed to participate in the early trials. But I can't verify that.

  10. ulala

    ulala New Member

    a lot of positive info about Ampligen on his website. He was involved in the clinical trials. Not sure how current his info is though/

    Kristina-thank you for the link for the zadaxin. I'm going to do some reading about it and ask my doctor if he prescribes it. I just quickly skimmed the link and it seems to be a fiarly safe drug. We never know how we'll react to any drug. I recentlytook Plaquenil for two days and had a terrible reaction, while most people have no problems with it. Thanks again!
  11. emmally

    emmally New Member

    from a source who does a lot of work rating drug companies that the are a couple of reasons why it got pushed back..The first being that it is extremely TOXIC and that is why that have not been able yet to get approval..and that somehow they have redone the drug to where it is not as toxic but have not yet proved it to the FDA....The FDA in recent years has cracked down hardcore on approvals so this could also be a factor.....
  12. Andrew111

    Andrew111 Member

    I read anecdotal information about ampligen patients having health problems and/or dying. But not whether it is higher than most CFS patients. IOW, we have higher rates of health problems, even without Ampligen. So is the Ampligen making it worse.

    Still, the people who were in past tests should have been followed long after treatment, along with their controls. And I have yet to see any indication that this is being done. I read one anecdotal report that this suggestion was ignored.
  13. SpecialK82

    SpecialK82 New Member

    Spacee - thanks for the info. It's curious that they died predominantly of cancer - I believe there is evidence that CFSer's may have a higher likelihood of developing cancer (or maybe it's just the subset that have EBV??).

    Anyway, from my limited understanding, I thought that Ampligen helps to turn on the part of the immune system that fights our stealth infections and it's the same thing that also fights cancer. I believe you are right that only the very sick participated in the early trials - maybe that had something to do with it?? I will be interesting to see the FDA's ruling.

    If approved, it seems we will see all the statistics on improvement and side-effects. I guess, though if they heven't followed-up with participants for long enough after the studies, as Andrew111 suggested, we won't know the whole picture.

    Ulala - good luck trying to get zadaxin - I wonder if it's only used experimentally in the US? If you try it, please let us know how you do!!


    [This Message was Edited on 03/11/2009]
  14. simonedb

    simonedb Member

    don't forget LDN, its cheap, effective, fairly beneign and it works
    only trouble is if you have bad chronic pain and it doesnt work well enough on the pain part then yr s.o.l., but it can treat pain effectively in a lot of people and to a point, too