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Major Move From FDA Puts Ampligen Back on Track

Discussion in 'Phoenix Rising Articles' started by Phoenix Rising Team, Jul 11, 2012.

  1. satoshikasumi

    satoshikasumi Senior Member

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    The FDA ought to have fast-tracked Ampligen for approval based on the phase II results back in 1998. They didn't. This was partly due to the perception that CFS was not a serious disease.

    Fifteen years later, CFS remains a crushing burden on the economy and no other drug companies have even gotten through a phase II study. There are no prospects for a treatment being approved for CFS in the next five years other than Ampligen.
    Other treatments being considered are much more dangerous than Ampligen.

    The agency said no in 2009 but they have a lot of discretion in how strictly they scrutinize drugs. They should consider the burden of CFS on society and the failure of any other drug company to make progress and give Ampligen the benefit of the doubt.
     
  2. 5150

    5150 Senior Member

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    how to avoid being debbie downer in our position? a difficult assignment, at which i am largely failing. my main roadblock is knowing that many people who have our damnable illness do not have the kind of medical coverage required to pay for Ampligen, so what's the difference anyway? after all, almost nobody has the kind of money that the Whittemores spent on their daughter. after 30 years of fighting, i am very tired indeed... and it is a big job to remain positive after seeing all the BS that comes with our trying so valiantly to get some help.

    best wishes to the younger ones. that's about as positive as i can muster up for now.
     
  3. Snow Leopard

    Snow Leopard Senior Member

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    It's all about building momentum. Approving a drug specific to ME/CFS is a big hurdle that will be very positive if achieved.
     
  4. MishMash

    MishMash *****

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    This is definitely good news. I won't be able to afford it, but it'll definitely be judged in the court of patient opinion.

    I'm hoping Dr. Peterson's subjects were long-term, intractably ill patients. Because the CFIDS Assoc stated on their web page (http://www.cfids.org/resources/newly-diagnosed-faq.asp) that a third of all persons who become ill recover completely: "...About one-third of persons with CFS recover almost fully, but no one knows why. Some people recover in small to moderate degrees, while others recover minimally, if at all...."
     
  5. Cort

    Cort Phoenix Rising Founder

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    That may be true but, on the other hand, some do - perhaps many - and an Ampligen approval provides them with a new treatment option. If you're low income the Affordable Health Care Act should provide you with insurance at very low or no prices beginning in 2014 providing its not repealed.
     
  6. satoshikasumi

    satoshikasumi Senior Member

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    Most drug companies will have a patient assistance program to give the drug free to uninsured, poor patients after the drug is approved. If Ampligen is approved, it will be very profitable and it is likely that Hemispherx would create such an assistance program.

    Second, if Obamacare is not repealed, you will be able to buy health insurance that will cover Ampligen in 2014. Please don't give up hope!

    The main barrier is the FDA's approval process. If it can pass that hurdle, you'll almost certainly be able to get it one way or another.
     
  7. satoshikasumi

    satoshikasumi Senior Member

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    Not to mention that most approved drugs for serious conditions have a patient assistance program to help people who cannot afford the medicine.

    This is how some patients are getting access to drugs like Valcyte now.

    Hemispherx would be able to create a patient assistance program if their drug was approved and profitable.
     
  8. Cort

    Cort Phoenix Rising Founder

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  9. snowathlete

    snowathlete

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    i guess its still three years from being available in the UK on the NHS, if everything pans out...
    Still, better than nothing.
     
  10. satoshikasumi

    satoshikasumi Senior Member

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    Almost no drug for chronic diseases has permanent effects. Immune-modulating drugs are almost always reversible (which is a very good thing for people who have bad side effects). Ampligen changes the functioning of the rnase-l system and improves natural killer cell function. If the virus theory is correct, this allows the patient's immune system to reduce herpesvirus levels over time. When treatment is stopped, the immune system is no longer being modified by Ampligen and the viruses can begin reproducing again. If the autoimmune theory is correct, ampligen shifts the immune system into a mode where it produces fewer autoantibodies. They are gradually depleted during treatment. When treatment is stopped, the body starts gradually producing the bad stuff again until the patient gets sick.

    There is a long delay both in responding to Ampligen and in relapsing after you stop it.
     

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