Ampligen - what the heck??

Discussion in 'Fibromyalgia Main Forum' started by SpecialK82, Jun 9, 2009.

  1. SpecialK82

    SpecialK82 New Member

    On May 26 Hemispherex announced that the FDA may require an additional 1 - 2 weeks beyond the much anticipated May 25 date.

    Well - it's been over 2 weeks, anyone know what is going on?? Argghh!

  2. cfsgeorge

    cfsgeorge New Member

    Previously, I sarcastically joked about the FDA's incompetence in approving Ampligen in a timely manner. It all started with the 1 year delay in 08' so they could analyze additional data that was missing. ok that 1 year delay was "fair" although taking an additional year to look at supplemental data seems very "sluggish" to me. But hey, who am i to question the FDA's very hardworking staff?

    But when the 1 year deadline came up in feb 09", the FDA gives us another delay of 3months for the final decision to be announced by 5/25(memorial day). On memorial day? A national holiday where all government agencies are closed? Good job Dumb-asses! The day AFTER memorial day 5/26, we get another delay from the FDA as we were told that they needed an additional 1-2 weeks. As of today 6/9, their 2 weeks are over and we haven't heard anything from the FDA. So now what? There is no memorial day holiday to blame it on this time. And we were never even officially told why there was the 3month and 2 week delay to begin with. This is all very unprofessional and incompetent behavior from the FDA.

    If Ampligen is approved in the very near future(aka: tomorrow), then all the delays will be "forgiven," but not forgot. With Ampligen's approval, it'll give much needed legitimacy to CFS/ME as a serious disease involving the dysfunction of the immune system or an immune disease. With its approval there will come more CFS research dedicated to the dysfunctional CFS immune system and the other dysfunctional systems that are interconnected to it. Moreover, future FDA approved drugs for CFS will more likely be of the immuno class of drugs like Ampligen. That will be a good thing!

    Now if Ampligen does not get approved, i am afraid that there is nothing in the horizon as far as the eye can see for another immuno-type drug. It took Ampligen over 20 years to get here now. And as of today, there are no other drugs nor any concrete plans to develop an Ampligen-like drug specific to CFS. Without Ampligen's approval, no one will try again to develop another CFS drug in that class. It would be too much of a financial risk/loss for the pharmaceuticals to even try again when Ampligen had already failed fda approval.

    Unfortunately, I can see the larger pharmaceuticals moving into CFS carrying their bags of assorted A/D's or re-uptake inhibitors. They've got plenty already, it's easy to get FDA approval, and it's even easier to make as many versions as you like. It's their perfect "mental" drug to treat all the physical ailments for all incurable and unknown "invisible" disease$. This is another huge money maker for the pharmaceuticals if they can push A/D's into the CFS market as they already have done with FM. I don't want what happened to FM, happen to CFS. Do you guys see what i see?
    [This Message was Edited on 06/09/2009]
  3. ulala

    ulala New Member

    paying off the FDA to not approve Ampligen? You can't make this stuff up! Very disturbing to even comtemplate! I hope I'm wrong in speculating what you meant.
  4. TeaBisqit

    TeaBisqit Member

    Let's pray someone just approves it.

    They can push their AD's and junk, but alot of the doctors I've seen are wise to it. They refuse to prescribe any of it. My last doc's office won't touch Lyrica or Cymbalta. My friend's doc won't touch it. And my new doc won't touch them. New doc went out of her way to go over all the pain meds with me and she and I decided to settle on a combo of barbiturate and acetaminophen, which actually does help my pain because the barb relaxes the muscles and calms the nerves. But it makes me too fatigued to function at all. But I'd rather be on it than any nut drugs.

    The FDA approves horrible drugs all the time that do not belong on the market and yet, when it comes to Ampligen, they have been withholding it from us for over twenty years. I just pray this will change soon.
  5. jasminetee

    jasminetee Member

    I've read that Ampligen made some PWCs feel better but they often crash once they're not on it. I'd be fine with taking it for the rest of my life if it helped me though unless it's ultra-expensive.

    I've also read though that some PWCs went from functioning poorly but still able to do some things most of the time to completely wheelchair bound. That scares me. I think it's because of this that Ampligen isn't being quickly approved of.

    It's a major dilemma for anyone.
    [This Message was Edited on 06/13/2009]
  6. TeaBisqit

    TeaBisqit Member

    They won't give Cymbalta or Lyrica because they said the drugs have horrible side effects and should never be given to sick people :D They also said these drugs are not meant for people who have chronic immune dysfunction as they do nothing to help the immune system, and their effect on pain is dubious at best. None of the docs in my town trust these drugs. And rightly so, IMO, since Lyrica is now known to cause suicidal thoughts and suicide itself.
  7. SpiroSpero

    SpiroSpero New Member

    Outofstep already posted the interview with Dr. William Carter, which can also be found at

    He was Professor at Hopkins and he says that he was one of the first MDs to work with interferon.

    Hepatitis C can be cured with interferon if caught at the right time.

    The interferon from Hemispherx is used for 12 different diseases.

    Broad spectrum drugs (with dual mechanisms of action) mostly have a broad spectrum

    CFS people have problem with immune system, NK function and energy production.
    Ampligen has benefits correcting that dysfunction.

    Gotta go. Please watch it. It gets interesting. I will watch the rest later.
  8. ladybugmandy

    ladybugmandy Member

    do you guys think that ampligen might work just as well as antivirals for CFS?
  9. SpiroSpero

    SpiroSpero New Member

    - very small amount of Ampligen improves influenca vaccine dramatically

    - japanese have a very high interest in ampligen, they are at the top of the scientific antiviral field

    - "We never contacted the Japanese, they came to us, they looked for an adjuvant but never found one until they read about cfs and ampligen. This got them interested."

    - Influenca is a special case, it has special guidelines. Guidelines are if you have a vaccine and adjuvant and you put it into humans and it is safe, it will get approved. Positive Immune measurements and safety are the two decisive factors to get approval. Tamiflu is only approved for seasonal flu but it is approved for this pandemic because there is no alternative. Regardless if the full guidelines have been met or not.
    Hem plans limited clinical trials and is scaling up our capacities (company is located in New Jersey)

    - major presentation about how you can increase the effectiveness of a cancer vaccine like that of a viral vaccine

    - we are bringing on new staff and not replacing anyone although the approval is ahead. we plan to expand.

    - most exciting period of 25 year history in this company. range of initiatives in cfs and other fields like influenca is wide. we have a manufacturing facility and we are deeply involved in clinical trials. our portfolio is growing. 60-65 people. we are operating at a high level of efficiency and have great experienced partners (world experts in japan). our people work six and a half days per week.

    Lets see what happens next week :)
  10. SpecialK82

    SpecialK82 New Member

    outofstep and Spiro thanks so much for posting the link and the summary info.

    The interview was very interesting, and does give me hope after hearing it. In answering a question about Ampligen's delay, he said that the deadlines that the FDA gives are just guidelines. He said (and I'm para-phrasing) how much more difficult this type of approval is than, for example, a drug to treat HIV as this is first in it's class - first to treat CFS, it's unchartered territory.

    Overall, I thought he sounded very positive and upbeat (although what else could we expect from the CEO).

    Can hardly wait - I am just feeling very good about this today!!

    [This Message was Edited on 06/13/2009]
  11. AuntTammie

    AuntTammie New Member

    if it comes out and no one can afford it, will the CDC (and others like them) turn around and say that we don't want to get better bc we won't even try it?

    I realize that this sounds sort of insane, but then I am talking about the CDC after all

    seriously if insurance doesn't cover it (or medicare), there is no way that many of us could possibly afford entire yearly income would barely cover 6 1/2 months of treatment if it's 20,000 a yr
  12. LonelyHearts

    LonelyHearts New Member

  13. LonelyHearts

    LonelyHearts New Member

  14. scruffpine

    scruffpine New Member

    I heard that ampligen can be used for hiv/aids and other viral conditions and that would make it cheaper whatever i am going crazy waiting to hear if it is approved or not i and my 33yr old daughter have been sick since 1990 and hope is getting harder to maintain i thiink ampligen is definitely worth a try since i am aperson with high viral titers and sudden onset all the numbers and percentages dont tell the whole story if it helps some subset of people than they can look for something else for those it doesnt help why do they need a one size fits all for us when with so many other diseases there are multiple options I pray it is approved it may be one small piece of the picture but a start and open other doors as others have said.
  15. scruffpine

    scruffpine New Member

    one more thought...... if it is not approved i want to start a campaign to have it approved if others can lobby for what they want why cant we? with all the conflicting interests out there we may be the only ones who can help us weary as we are. love to all
  16. DavidJ.

    DavidJ. New Member

    its not approved yet?? i thought i could buy some shares and get rich after the approval,lol!
  17. SpecialK82

    SpecialK82 New Member

    It's hard to believe I posted this thread a month ago and we still do not have a decision. Apparently, the FDA is behind in other deadlines as well, so it is not just Ampligen.

    What seems weird to me is that the FDA would always give a new deadline each time there was a delay. As irritating as the delays were, we always knew when we would here more.

    Now, it's just left up in the air. It doesn't make sense to me, that the FDA was so close to releasing a decision at end of May, that they only needed a 1 - 2 week delay, now that time has come and gone and they remain silent. Why are they not giving us a new deadline??

    It makes me wonder, does hemispherex know more then they are telling us? Why wouldn't they ask for a timeline from the FDA so that they can inform their stockholders?

    It's making me nervous - just more bizarre happenings in the Ampligen world.

  18. znewby

    znewby Member

    Thought you might be interested in these comments that I read on the About site.

    To: Blown.Away
    Posted: Jun 16 09 12:38 AM
    Message: 11004.2 (2 of 4) Reply to 11004.1

    Greetings to BlownAway and the entire CFS/ME Community:

    The basis for my answer stems from being an Ampligen patient for nine years and observing (my opinion only- I have no medical experience) the effects, visual or stated, of dozens, maybe seventy other patients who came, received a certain amount of drug from the research infusion center over time, and left.

    My ties to Hemispherx Biopharma (HEB):

    During my first year on the drug, they paid for one trip that was activist-related. They did not ask me to speak in their favor, but I did due to good results from being on the drug. Frankly, I was overjoyed to be well enough to escape from my bed-prison and be able to travel and be social again. It seemed a miracle. (I later crashed due to the good 'ol reason of overdoing it. But later recovered, then down again#. I also toured HEB in Philadelphia and met senior staff.

    2# I own about $2,000 in HEB stock, this being the gain from a previous stock transaction.

    Quick Answer:

    I believe Ampligen is a safe and effective drug which will meet FDA criteria in the very near future #risky statement based on history!# and will be approved for treatment of CFS/ME. It is expensive and must be IV infused.

    The Story:

    #HEB#, a small, one-drug #essentially# biopharmaceutical company, has invested an unusual amount of time and money in clinical trials and research for their flagship drug, Ampligen #Amp). The incredible delays, time and time again, may be attributed to small-company inexperience with the FDA, dumb common errors, lack of political savvy in DC and with FDA, battling illegal short-sellers and ugly takeover attempts and lawsuits. Lastly, William Carter, CEO, noted for brilliance in co-discovering Interferon, is said to act like a bull in a china shop. This managing style raises the hackles of FDA, audit firms and the big pharmas, who know how to better massage FDA. FDA has had leadership, staffing and organizational changes of their own which has added to the above delays.

    Research personnel at our infusion center #I believe there were eleven centers nationwide) were prohibited from divulging any Amp progress info to patients, and patients were strongly admonished to not share personal Amp info to other patients, but we were bored and talking did occur. No one to my/our knowledge anywhere experienced a side effect that would jeopardize approval of Amp. Overall, it was impressive to see how well it was tolerated even by the very ill with allergies and chemical sensitivities. Yet there were some patients who did not tolerate the drug or had to adjust dosing frequently. Bear in mind the average participant in the earlier trials was very, very ill. Later on there were those who had recently been diagnosed. In my opinion the earlier a patient started on Amp after diagnosis the better and more swift the recovery was, if there was one. Those of us ill for a decade or longer received longer treatment and saw less improvement. If that sounds discouraging, consider being bed-ridden for many years, then within three weeks being able to lightly participate in many life activities. For me there was a sustained 25% improvement from the above condition. It was hard to not overdo and crash, being a former Type A adrenaline junkie. Eventually I had to stay on a maintenance dose just to hang on to diminishing improvements, and finally stopped altogether. I have become extremely ill since, but estimate Amp prolonged my life about four years, and I had many good months. Strong Note: I had the third worst treadmill numbers ever at this site and I may hold a record or near record for most Amp infusions ever received by one person, so read my story with that in mind. I am not a moderately ill patient!

    The average patient stayed for roughly nine months and saw satisfactory improvement. Many chose six months, went home and returned to their former lives. Those miracles, and I use that word carefully given the implications, were not uncommon. The unknown was how long they held their wellness. Sometimes we would hear of so and so who went back to college, or work and continued to do well.. Once in a while a former patient would come in for a 'tune-up' , being a short number of infusions, and leave. Yet some tried and tried and saw no benefit after an expensive attempt. These were a small and painful minority.

    I've heard the FDA will approve a drug if 11% of patients see some sort of benefit. I've also heard placebo effect can approach this same figure. I can assure you Amp brought measurable improvement to at least four times that number of the patients I saw, and I'm underestimating on purpose. Also note an unusual number of very, very ill patients were the first to get infused for compassionate reasons; that would artificially skew the numbers downwards from expected norms. The other half of the equation is efficacy. Is it safe? Yes, as stated.

    This was a cost-recovery trial, not the more common double-blinded trial. This because HEB was too small to afford the expensive route. They needed patient reimbursement for an expensive drug. Upon approval, insurance companies and state programs will be available to you for coverage.

    It took two CFS/ME days to write this, and I still cannot guarantee it is correct. Generally though, you get the picture, and it is a good one.

    Best of health to all of us. We certainly need it.

    Report abuse

    drwell (drwell)
    Last Visit: Jun-17
    Posts: 1


    To: Blown.Away
    Posted: Jun 17 09 12:46 PM
    Message: 11004.3 (3 of 4) Reply to 11004.1

    As others, I can only report my personal story. In 1988, while living a full, full life as RN managing a Pain Center, mother of three sons and Lutheran Pastor's wife, I became suddenly very ill with what was to be diagnosed as Chronic Fatigue Syndrome. Two of my sons, age 11and 8 were also ill. They had recurrent bouts of EBV and our life turned into hell. I had to quit my job and take a FML and the boys missed many, many days of school. They had a very astute Pediatrician in Lexington Ky who asked our permission for an investigational drug study, for Ampligen, for Adolescent boys with Recurrent EBV. By that time my ex-husband had taken the younger one to the Mayo Clinic and he was diagnosed with CFIDS.

    Both boys recovered and have never had a repeat. Meanwhile, I stayed very ill. So, do I think this is the drug for CFIDS-yes!!!!!!!!!!!!!!!!!!!!!! I have contacted the company many times and have told them that I would go anywhere in the USA for any length of time to be in a clinical trial. We talked, but never worked anything out.

    I divorced, had to stop my career of nursing and moved back home to Wisconsin. I remain very ill, but do work one day a week as a Nurse in Independent Practice. I am so deconditioned that a six hour shift leaves me short of breath and exhausted. I stay on SSD and have a husband who carries Health Insurance, but what I have most is his total and unwavering support. I await Ampligen and will not try anything else, except sensible diet, pacing of activity and Ambien for sleep as well as an anxiolitic. My fibro is helped much with Lyrica, but I have many side effects and could not affort it if my doc had not gotten me hundreds of samples.

    CFIDS really almost ruined my life, but I do have hope of Ampligen. Now, whether my health insurance will pay for it is another story. I do know that I will hire a lawyer to get the drug. I feel that if I could have 5 good years of live back, it would be worth it.

    Report abuse

    BigBlue2 (BigBlue2)
    Last Visit: Jul-8
    Posts: 2


    To: Blown.Away
    Posted: Jul 08 09 02:19 AM
    Message: 11004.4 (4 of 4) Reply to 11004.1

    I'm sorry about being brief here, but I find I can't do a lot of typing at one stretch.

    I an long time member who has not monitored the forums in a number of years.

    I have had CFS for over 15 years. After being sick for 4 years and trying everything that my Dr knew about , to no success, I moved halfway across the country to be in an Ampligen trial. I had high hopes that it would be what turned around my life.

    I was in a group of maybe 10 other patients. We all knew what was happening with all the other patients in our group as we spent a lot of time together.

    Personally , had a really really hard time with the drug. I became sick after every treatment. I came home from every treatment and slept for almost 24 hours. My level of tolerance for any new stressors dropped incredibly low, though it was really low to begin with. I knew I was on the 'real ' stuff, as once I had an episode where the fluid didn't go inot my vein. I had a reaction unlike what I would have had had it been just saline solution.
    After nine months I decided I couldn't take it any more and left the trial. I made it through the double blind part , so I had done my part for the study. But Ampligen wasn't helping me.
    I do know that 1 person in our group found great relief from it. And a few years after the trial I heard he was buying for himself at great expense.

    My personal feeling is that it may work for a small group of people. If they can figure why and what group that is, then the drug will have great pupose. But people need to know before trying Ampligen , should it be approved, that it can have really rough side effects. Really rough.
    Knowing that, if I had to do it over again, I still would have gone through with trying the drug. I just wish that the company, and the Doctors, had been more forthright with information about its side effects.

    I know this isn't a lot of information...but maybe something in it will help.

    Good luck Blue2
  19. jasminetee

    jasminetee Member

    Thank you so much for posting this. It's very helpful. I am much worse after Valcyte and I want to know this kind of info to help me decide if I should try something else.

  20. SpecialK82

    SpecialK82 New Member

    Thanks znewby for taking the time to post these accounts. It's difficult to guage this drug - some have such great reactions, some have negative ones. I really wish they would have subtyped these groups in the clinical trials.


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