Ampligen..Info from 1st trial user....PLEASE READ

Discussion in 'Fibromyalgia Main Forum' started by Diva55, Feb 20, 2007.

  1. Diva55

    Diva55 New Member

    I was surfing the internet for info on Ampligen as it sounds so promising.

    However, I came across this article from someone who was in the first trial for the drug & took it for 5 years.

    It was rather off putting! (written in 2000).
    Still I thought it worth posting as i'm not sure if it's been posted before:
    ----------------------------------------------
    This is an important open letter from the very first patient taking Ampligen:


    The incorrect folklore around my experience with Ampligen is frustrating. I have tried to keep a low profile but I will explain to you why I am now speaking out. I am trying to clear things up -- and hopefully still keep that low profile.

    I have been told numerous times about the exaggerations by Hemispherx and some of the P.I.’s (principal investigators) regarding my “successful recovery” and I chose to ignore them and spend my time getting well -- not getting even.

    However, if someone calls me and asks me a direct question concerning the drug -- they will get an honest and direct answer. That is my style. I am really concerned about the false impression they are giving about my five years on Ampligen. It incorrectly influences people who are considering hocking their life’s savings and their health by what they are told about me and what Ampligen is capable of accomplishing.

    After 5 years on the drug (400 mgs 3xs a week) and a lot of side effects -- plus not getting well -- no one should know better than I do -- what this drug can and can’t do.

    The last straw was when a friend of mine sent me a copy of the U.S. patent (number 5,958,718) which was filed by Hemispherx and granted by the U.S. Patent Office. In their application Hemispherx claimed patient 00 (me) was a professional golfer and was now “leading a normal life fully self-sufficient.” Seeing as I had an 18 handicap back many years ago when I was able to play golf (not bad for a sweet little old lady), I would hardly qualify for professional golfer status. Professional golfer’s handicaps are 0 -- thus no handicap is used when they play in tournaments. Not to mention they play for money.

    As far as "leading a normal life and am self-sufficient" -- I should be so lucky. Ask my husband, who cares for me (even though he has Parkinson’s Disease), how correct that statement is. Those are bold face lies and it bothers me.

    We are seriously considering going to our lawyer ( who is a very good one, I may add ) and ask him to write a letter to the FDA and the U.S. Patent Office telling them the truth. I doubt if we would sue at this point — just inform both agencies...but if I hear any more of that sort of thing -- they had best watch out!! Lying to the government is not one of my strong points. U.S. Senator Pete Domenici (R-N.M.) was very instrumental originally — in 1988 — helping me to obtain Ampligen on a compassionate care basis. He is a very powerful senator and one of those rare politicians who is extremely honest and keeps a very personal relationship with his constituents. In fact, I may go to him with this issue. I respect his honesty and excellent reputation so he deserves the truth and so does the FDA and Patent Office.

    Now -- let’s see if I can answer your questions. Does Hemispherx, FDA, Dr. Peterson, or Dr. Levine, etc. --- have my correct address ---- yes, absolutely --- and the same for most of the others. In fact, Dr. Peterson wrote to me several years ago and offered me the opportunity to go back on the drug. My answer was a resounding and emphatic ---- NO!!

    To be honest with you -- if I had it to do over again, I would not go on it the first time around knowing what I do today. I was astounded when I reported the heart problems to the doctor who was my principal investigator -- and his answer was “Ampligen couldn’t have caused that” and that was it. How would he know, and shouldn’t it have been reported anyway?

    At this point NO ONE in the original study with whom I am acquainted -- or those in the following double blind placebo study — is well. (The double blind placebo study is jokingly called the "double cross" placebo study as Hem did not keep their word.)

    I was on the drug the longest. NOT ONE, including myself, of the participants I know (and I exchange info on a regular basis with MANY OF THE ORIGINAL RECIPIENTS) has been contacted in ANY way by Hem or the FDA, etc. Scary, isn’t it?

    I know one of the first 10 Ampligen patients has Mantle Cell Lymphoma, and a second person who was one of the original 15 has stage 4 cancer. Another of the first 10 has found a lump in her breast and is seeing an oncologist next week. Two of the first 10 have committed suicide.

    I had a hemangioma tumor removed from my liver in November, plus all the heart complications. Nothing has been documented. Seeing as many of us were on the drug 4 or 5 years -- I find this disinterest amazingly careless, or maybe they don’t want to know or admit to developing problems. Who knows -- but is this how all drugs are approved??? I hope not.

    You would think that would be of interest to the FDA seeing as we were all on Ampligen for years. It seems logical we would be of great interest to those people responsible for both the safety and efficacy of this drug, such as Dr. Levine. As far as the arrhythmias and mitral valve prolapse --- no, I did not have either before I took Ampligen. They were diagnosed by the Johns Hopkins cardiologists, after I was off Ampligen, who found I also had NMH. I was treated by a cardiologist (electrophysiologist) in Albuquerque for all those complications.

    We have the arrhythmias calmed down now, but it took several years. You asked about intolerance for alcohol -- yes, I have always been intolerant. My husband kiddingly use to called me a “cheap date” because I never ordered an alcoholic drink while we were dating. With all my medical bills now, I don’t fit in the category of a cheap date anymore.

    You are welcome to share this information with anyone. It is the simple truth, and I think that truth is needed in this vast web of inappropriate information regarding Ampligen.

    From the CFS BULLETIN
    January/February 2000




    [This Message was Edited on 02/21/2007]
  2. Catseye

    Catseye Member

    The people selling the drugs are the same people in charge of the studies of the drugs. Why this is allowed to happen is beyond me. They can pretty much get away with whatever they want. They already are. The more expensive the drug, the more incentive to exaggerate or, in this case, to lie about results.

    Maybe one day we will have a REAL independent administration to do testing of our foods and drugs. It seems like awhile back, we had a myriad of drugs being discovered constantly for all kinds of great things, but now people are just patent hungry and many of the "new and improved" drugs aren't really "new and improved", after all.

    I hope this will get people to investigate this matter before spending tons of money on Ampligen.

    karen
  3. spacee

    spacee Member

    There is nothing like first hand experience. Very sad.

    Thanks,

    Spacee
  4. pastel

    pastel New Member

    bumping this important information.
  5. Diva55

    Diva55 New Member

    Thanks to everyone for their replies. Yes it was a very distressing account & I'm sorry to hear that she is not doing well today.

    Many years ago I worked for a major drug company, involved in the periphery of 3rd phase clinical trials.
    I won't reveal details but I was appalled to learn some awful facts (after I left) on the way drugs got through to the open market.

    I try when possible to avoid drugs as I know all companies are the same. It's difficult with our illnesses & sometimes the only relief is through drugs & I have to give in.

    I know people are desperate for help but please do all the research you can before trying anything.

  6. spacee

    spacee Member

    It just came to me. I remember an article where this woman gave a talk to docs about how great Ampligen had been for her. I remember her saying that she was patient 00 and that she wished that that was her golf handicap and everyone laughed. Ampligen had brought her out of a wheelchair.

    There were others who were so desparte for the ampligen that when the trials were stopped by the FDA that they sent letters "DEMANDING" that the trials be restarted. The FDA said no...was it possibliy because of the two suicides. The FDA got a very bad rap for stopping the trials.

    Then the trials went to Belgium with Dr. Kenny D. and then without explanation he stops using Ampligen.

    Ok. Then I was watching the DVD by Dr. Cheney "The Heart of the Matter". He for a brief 30 seconds or so was showing a chart that had patients response to something (wish I could remember what). The normals had various responses. The CFS patients had NO RESPONSE. Dr. Cheney said, "It was this finding that led to Ampligen being developed". That was all he said.

    Ok...well, this is my thinking. Ampligen started out on a positive course. Sadly, after spending millions of dollars, they have no disease that it works for and possibly should not be used. The money is all wasted. Believe me it is NOT all pharma money either. Before the company went public, the owner persuaded alot of his personal friends to invest to "get the drug going...to make money for them but to HELP us too.

    So, now we have the bad with the good which happens in life.
    BTW, I read about her remarks to the physician's conference in the CFIDS Journal.

    Spacee

    PS this is later. Sorry about the error about Dr. D. in Belgium. My memory failed me, yet again. Read Katrinaxx's post.
    [This Message was Edited on 02/22/2007]
  7. karinaxx

    karinaxx New Member

    , but a bit confused.
    what about Mary Schweitzer, who claims it is a big part of her recovery?

    spacee, not true that Dr.Meirleir just stopped it without explanation. He did explain in one of his interviews, that Ampligen did show promising results in the beginning, but later on did not keep this promise and so on..... i dont remember the exact wording, but i remember seeing his comment.
    i will ask him in March, when i see him.

    karina
  8. u34rb

    u34rb New Member

    I've read that ampligen can be useful in small doses as it amplifies the effect of drugs like tamiflu, which is the first line of defence against bird flu. That is, if a small amount of ampligen is taken as well it means that only a tenth or a twentieth of the normal amount of tamiflu is required. So it's not all bad news.
  9. wrthster

    wrthster New Member

    I have read that story and it is very sad. Maybe someone should send it to Dr. Lapp who seems to have a major interest in the company who produces it. We all blame the FDA for many things, but in this case it looks like they have done the right thing in keeping it off the market.

    It has been trying to gain FDA approval for so long now, there must be a very good reason it is still not approved.

    My own opinion is the answer lies in stem cell and gene therapy. This is where I will we need to advocate research as a community. Combine with people who suffer from Lyme ect. And it is not frequently discussed on the board, but I think more research need to be encouraged for a product that has a good safety record, been around for many years, and that is Gamma Globulin.
  10. Diva55

    Diva55 New Member

    Now that does confuse things! As I said I just found it on the internet and Erik does seem to back up the account.

    As others have said the FDA has blocked it and I presume for good reasons.

    I know we all use powerful drugs & side effects can be awful.I have used Lyrica and the side effects, for me, were just horrific but in desperation I caried on for many, many months with the side effects to get the benefits. I really don't know if I'll have any further complications for having been on this drug for almost 2 years.

    With newly released drugs we don't know all the side effects & the side effect leaflets are rarely updated unless the drug have almost killed a lot of people!

    I know how side effects are tracked in the clinical trials & believe me not all can be captured. We are, after all, very different in how we react to chemicals being put in our bodies!

    I just hope that people who decide on this course do a lot of research on it.

    Interesting fact on Ampligen making tamiflu more effective.


  11. cherylsue

    cherylsue Member

    Where are you seeing Dr. De Meirleir? Is he still practicing? I thought he was in the United States now. I read that he may be even involved in the new Reno Research Center.

    Anyway, I am very interested in his protocol. I'm impressed with some of his research and the identification of the subsets of CFS. I fit one of the profiles. I've been just picking up pieces now and there of what he recommends.

    I started Nexavir gel and I've been on it for a week. I wonder what he thinks of this antiviral.

    Please share your visit with us on the board.

    Wishing you the best,
    CherylSue
  12. LouiseK

    LouiseK New Member

    This drug business is really "buyer beware" as to what gets on the market in the first place and as the recent huge government report re-stated (which we all know) there is virtually no tracking of what goes on with any of these drugs once in the public's hands.

    Diva, please do share your unfortunate experience with Lyrica. I feel I have been really forced to take this drug by my doctor (my GP) although I have spoken to two neurologists who basically never prescribe it and an endocrinologist who discouraged me from taking it.

    I can tell you for my part I find it to be the most highly addicting thing ever. If I miss one dose I become sick as a dog and I've seen zero benefit thus far. . .

    What went on with you?

    Thank you.
  13. karinaxx

    karinaxx New Member

    i have an appointment in March with him.

    i dont know if he is now in the States, possible for a visit. i know he said one time he could not pactice in the states, because of some regulations.

    how is it going with the Nefaxir creme (gel) ? ANY SIDE EFFECTS? any effects?

    as far as i know , he changed his strategy a bit; carla NL was just recently in his clinic and it was not very clear to me what is exactly going on.

    if you search for carla NL you most probably find all the recent stuff.

    of course i will come here and tell you all about it, how can i not!

    take care
    karina

  14. Diva55

    Diva55 New Member

    Hi Louisek
    Oh dear I'm sorry I didn't mean to mislead you and put you off Lyrica. It was a life saver for me.

    I'm overly sensitive to meds and got all the side effects in huge doses!.

    I was impatient to go up to the highest dose and was railed back by my doctor but on the highest dose of 600mg a day I had narcoleptic episodes - fell asleep walking up the stairs for 4 hours, cup of coffe still in hand. Fell asleep in the bath for many hours, fell asleep on the PC keyboard. I also had lots of hallucinations.

    BUT, BUT that was me and many don't have any side effects. I gradually came down to a manageable 300mg a day and coped very well with that.

    I have taken Lyrica for 2 years and have only decided to come off it gradually as I feel 2 years is long enough (for me) on a powerful drug.

    And I've only been able to do that by having Recuperat-ION working for me in pain management. It's almost as good as Lyrica & manages the pain with the addition of Lyrica when the pain is really bad. If I didn't have an alternative I would still be on a full dosage of Lyrica.

    SO please do not let MY side effects put you off in anyway. I would always recommend it as I was bed bound for a long time before I took it!

    Maybe you need to adjust your dosage and it does take a while to kick in for the benefits - a number of months for me but some have reported feeling benefits in a much shorter time.

    Sorry for misleading you.
    Best wishes



    [This Message was Edited on 02/22/2007]
  15. LouiseK

    LouiseK New Member

    No apologies necessary. I was not mislead, just unclear. Thank you very much for your thoughtful response.

    I shall proceed.

    Best wishes to you.