Ampligen Delayed Again By FDA

The FDA has delayed once again the approval of Ampligen as the first prescription treatment for ME/CFS.  The FDA’s decision was supposed to be due on May 25th.  The first approval date was set to be sometime in February and was then postponed for a May decision. 

Hemispherx, the manufacturer of Ampligen, says that the FDA needs another week or two because of staff scheduling changes.  Is this really the hold up or is it just the FDA still not taking ME/CFS seriously?  CFS has been put on the back burner by the FDA many times over the years and we (CFS patients) have felt neglected and have felt that the FDA does not consider our illness as debilitating or as serious as some other illnesses.

Not only has Ampligen been studied for treating ME/CFS but it has also been studied to treat AIDs, Hepatitis B & certain types of cancer.  Side effects of Ampligen include flu-like symptoms that Hemispherx says will typically subside after the patient has used the medication over time.  Ampligen is said to work by down regulating an immune pathway (RNase L), which allows the immune system to fight infection better.  According to a study by Dr. Richard Podell, Ampligen increased performance of ME/CFS patients on a treadmill by 22% after patients were treated for 40 weeks.

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  1. debra van ness says:

    It is rediculous the amount of stigma we have had attached to FM/CFS in the U.S. I can understand that it is not only here, but everywhere else as well. Because people cannot “see” some broken bone or bruises, they assume we are a bunch of whiners who wnat attention for a non existent disease. Well, I am here to tell them all, it is real, it is very painful, and the “tired” we experience is nothing like the “tired” of the healthy person. No matter how much I sleep or how little I sleep and no matter what I try, I still feel as if I have not slept in weeks. This is everyday exhaustion and pain that cuts to the core. I remember the days when I would be “tired”. Believe me, this is not merely “tired”. I even remember the days when Tylenol would fix any pain I had. NOt so anymore.
    I will be glad when the world wakes up and realizes that their friends and family members with this disease are truly very ill. We have invisible bruises that we very much feel, flu-like aches which are VERY real, and fatigue which feels literally like we have weights attached to our bodies from the overwhelming exhaustion.

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