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.