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Ampligen Update: Fight for Approval Slogs On

  [ 10 votes ]   [ Discuss This Article ]
By Charles Lapp, MD • www.ProHealth.com • December 27, 2012


ME/CFS/FM clinical researcher Dr. Charles Lapp directs the Hunter-Hopkins Center in Charlotte, North Carolina. He received FDA approval to administer the experimental intravenous drug Ampligen to ME/CFS patients who could cover the cost 15 years ago, in 1997. Since then he has found that some patients achieve significant improvement on Ampligen, while many others improve. This update is reproduced with kind permission from HHC's December 2012 ME Letter.

*    *    *    *

Ampligen is still struggling for FDA Approval.

Dr. Lapp, Wendy Springs [Dr. Lapp’s infusionist & research coordinator], patient Robert Miller, and Hemispherx consultant Nancy McGrory met in the Summer with key politicians and the Department of Health & Human Services.

The plan was to educate DHHS about Ampligen and our past efforts with the FDA; our goal was to stimulate public hearings and face-to-face meetings with the Food & Drug Administration concerning this one-and-only therapy for CFS/ME.

To that end, DHHS held a public webinar on the subject on September 13, and another on November 15. Details can be found at www.fda.gov/Drugs/NewsEvents/ucm319188.htm .
 
On December 20, stakeholders met with an FDA Advisory Committee. [For background, see “Dec 20: High Noon for Ampligen and Chronic Fatigue Syndrome.”]

In addition to reams of data supplied by Hemispherx Biopharma (the manufacturer of Ampligen), the Advisory Committee heard testimony from researchers, patients, and supporters.

Despite data acquired on over 800 Ampligen patients, the committee voted 9-4 against recommending the drug for commercial approval, citing inadequate information on efficacy and safety in CFS/ME.

They recommended yet another large and prolonged study of Ampligen, which has undergone at least 8 different studies in the past 24 years already!

Stakeholders are infuriated, of course, pointing out that there is no other treatment option currently available for PWCs (people with CFS).

The agency (Food & Drug Administration) uses such advisory committees to obtain expert scientific opinions on a proposed medication, but the agency is not bound by such recommendations. The FDA has a deadline of February 2 to either approve or disapprove Ampligen therapy.

For more details on Ampligen see our website, then click on “Research” and then the “Ampligen” tab.




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