Public Comment at FDA Stakeholder Meeting, April 25, 2013

My name is Jeannette B. I am paying for my own expenses for being here for this meeting.

I am here to urge the FDA to play a more proactive role in working with Hemispherx towards the accelerated approval of Ampligen. Quite obviously, a sub-group of ME patients has been identified as a result of their being  Ampligen responders and a tremendous amount can be learned from that. Yet, one gets the impression that the agency is not all that interested in the drug. Ampligen is not even a topic at this drug development workshop. Dr. Peterson, the physician with the most experience and success in administering the drug (and many other treatments as well), has not even been invited to be on one of tomorrow’s panels. One has to wonder if the FDA does not really want to learn from his vast knowledge and experience.

At the Ampligen FDA Advisory Committee meeting, the FDA stated that there is no path for Ampligen’s approval under any fast-track program. No explanation was given. In contrast, the FDA has recently developed new guidelines for an accelerated-approval process for Alzheimer’s drugs for patients who are not even sick yet! Why the drastically different standard, I wonder?

Looking back at the approval of AZT as the first drug to treat HIV and AIDS, it becomes clear that the FDA does indeed have discretion to adopt loser rules if the circumstances warrant it. At the end of last year, the FDA approved—under an accelerated approval program—Sirturo, a drug to treat tuberculosis that is five times more likely to kill patients than the standard drug treatment for the disease without proof of increased efficacy.

I am not convinced that the FDA’s hands are indeed bound when it comes to an accelerated approval of Ampligen.  Instead, it seems that an unfortunate double standard applied by the FDA to ME and Ampligen compared to other diseases and drugs has Ampligen headed straight towards the cliff, as Hemispherx is running out of money and the drug is going away, potentially forever.

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6 Responses to Public Comment at FDA Stakeholder Meeting, April 25, 2013

  1. Anita says:

    Jeannette, thank you for goving such a clear and excellent summation of the situation!!

  2. Laurel says:

    Thanks for telling it like it is! Good job.

  3. Donna Robillard says:

    Thank you for doing your research and serving it back at them.

  4. Thank you for an excellent concise statement. This meeting was billed as ME and CFS. ME was neglected and panel relegated to “ME/CFS” groups. We really do not need to be lumped into the CFS group anyway (and ME/CFS does not exist as an actual diagnosis). ME patients need their own meetings!

  5. Kathy D. says:

    Thank you for your adamant, strong and clear statement. This whole situation is absurd, as the FDA appears frivolous and mpt serious about helping anyone with ME/CFS with treatments that work with some sufferers and could help more.
    Yet, you keep trying. For that, we thank you.
    If only we could follow ACT-UP’s example and sit in and do whatever it takes to get attention and treatment for this disease.

  6. Pingback: My May 2013 CFSAC Testimony | Thoughts About M.E.

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