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Added benefit of subset analysis insufficient for keeping safe drug from patients with no alternative Jan 17. 2013 | Comments (41)

An FDA "no" to Ampligen would significantly slow down investment in chronic diseases in general. They voted it safe. They're not contesting its effectiveness per se, they mainly insist on knowing which subset is affected more than others. We're not saying this doesn't belong in an efficacy profile, we're saying its added benefit doesn't outweigh the tremendous human and financial cost. It's an insufficient justification for keeping a potentially life-saving drug from bed-ridden patients with no alternative. Authorities in Canada and Brussels approved it 2 decades ago. Do you really think they're less diligent? Respect our right to decide with our doctors and provide incentive for sponsors to give drug companies the means to get those subsets refined. We already know the subset that matters most. They're called ME/CFS patients.


  1. # Peter on 17 January 2013 at 20:20:

    Hi All,
    what you need is public!
    You can’t win without public power!
    It’s nobody here with a friend who have connection to a radiostation and/ or TVstation?
    Show the world all the pain, tell the world about the petition about the e-mail action,
    tell the world what happend at the adcom!
    Tell the world the opinion from Klimas, Bateman, Enlander, Peterson, they all support Ampligen.
    The world must known, every doctor that has used it for the past ten years strongly supports Ampligen.

    A lot of public pressure!
    That’s your only chance!
    Otherwise you loose, that’s for sure!
    Good Luck!

  2. # Adam on 18 January 2013 at 1:25:

    I have done my part with friends and family. This needs to be kicked up a notch as the FDA can say "no" anytime prior to Feb 2nd as they have done in the past. If the "no" is issued prior to Feb 2nd, it will be very difficult to undue/fight that that change.

  3. # Peter on 25 January 2013 at 19:46:

    Newswise — Ampligen, the first drug ever seeking approval to treat chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), recently hit another roadblock with the U.S. Food and Drug Administration (FDA). In its long quest to treat 1 million Americans suffering from this debilitating illness, the FDA advisory panel did not recommend the drug to be sold on the market, largely because CFS/ME doesn’t have clear biomarkers such as blood tests to define patients who most likely to respond to the drug. Data from clinical trials of Ampligen has not convinced the FDA so far.

    The real loser is not Ampligen, but CFS/ME patients whose daily suffering continues to be unabated. CFS/ME feels like you’ve been run over by a truck – pain, inflammation, utter exhaustion and trouble concentrating.

    I have been caring for patients with CFS/ME for 26 years now. It’s heartbreaking seeing them struggle and suffer from this serious illness that has been trivialized by science and society. One of the early controversies quickly disproven suggested that CFS/ME is a form of depression. This led to enduring public policies that allowed insurance companies to limit coverage to CFS/ME to either mental health or exercise therapy, neither get to the root cause of CFS/ME.

    CFS/ME researchers, including myself, have seen major advances in our understanding of the biology of CFS/ME. It seems to resemble an illness we know how to treat like multiple sclerosis (MS), chronic viral diseases and autoimmune diseases.

    Around since the late 1980s, this drug is not new to science and medicine. Two phase 3 clinical studies have been completed. The data shows that a subgroup of CFS/ME patients showed marked improvement, even recovery on the drug.

    Yet, that’s not enough evidence for the FDA advisory committee to approve because they would like to see a conclusive biomarker. As a physician, I could live with this decision if I had other effective therapies to treat my CFS/ME patients. But I do not.
    Moreover, it defies common logic in used in drug approval for other complex immune mediated diseases.

    Take for example, MS: Its earliest approved treatments had opposite immune effects. One interferon increased immune activity and a second interferon quieted immune activity. In the studies that led to approval, MS drugs, like Ampligen, had about a 40 percent success rate.

    Clinical research for these early MS drugs produced no biomarkers other than a patient’s successful response to therapy, such as the case of Ampligen. The biomarker the FDA relied on for approval of MS --- seeing if the lesions in a patient’s brain decreased -- had no correlation to the patient’s improvement.

    Why would the FDA approve MS drugs before there were concrete biomarkers to determine success? The answer is simple. The advisory panel saw MS as a serious disease that required interventions ASAP, and were willing to accept that clinicians would better understand where to use the first drugs with more experience using them. Now there are seven approved drugs for MS that have significantly improved quality of life for patients. But they are not willing to use the same logic for Ampligen.

    Because CFS/ME patients are stilling waiting for their first therapeutic, Nova Southeastern University (NSU) in Fort Lauderdale, Fla. has brought on board a nationally renowned group of experts to form the NSU College of Osteopathic Medicine Institute for Neuro Immune Medicine, which will open in February. These doctors and scientists will conduct basic research using genomics to help further develop drugs to treat this disease, while they treat patients. They are also doing clinical testing for Ampligen.

    With or without a biomarker, the FDA should recognize the seriousness of CFS/ME and approve Ampligen, and open the door for other targeted therapies now.

    Nancy Klimas, M.D., one of the world’s leading researchers and clinicians in chronic fatigue syndrome/myalgic encepahalomyelitis (CFS/ME), is the director of the Nova Southeastern University’s College of Osteopathic Medicine Institute for Neuro Immune Medicine

  4. # Peter on 1 February 2013 at 22:19:

    CFS Patient starts Hunger Strike for approval of Ampligen

    http://www.cortjohnson.org/blog/2013/01/31/chronic-fatigue-syndrome-patient-goes-on-hunger-strike-ampligen-approval/

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Links

ME/CFS Facts

Center for Disease Control on CFS

Wikipedia on Rintatolimod

A patient who was at the 20 dec FDA Arthritis Advisory Committee meeting about the approval of Ampligen

Audio recording of above meeting

Alternative names for CFS

FDA on postmarket REMS programs



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