1,000,000 patients in the US suffer from ME which the FDA has stated is a serious, life-threatening and complex illness, yet there is no FDA approved treatment.
Ampligen has been used to treat M.E. patients for more than 20 years (100,000+ doses). Experts agree that they have seen improvement in approximately 40% of patients using the drug.
The FDA advisory panel say that the drug is safe. It is the tortuous process of meeting the different standards and requirements for approval of 5 FDA divisions, combined with an FDA lead reviewer who admitted at a public meeting she did not understand the disease, that has blocked the approval of this treatment.
A hearing is needed to examine whether M.E. patients are being unfairly prevented from accessing a treatment which may benefit many.