Ampligen Gets Good Press on Pharma Media Site


Founder of Health Rising and Phoenix Rising
Staff member
Equels is definitely getting out there - pressing the flesh - doing the interviews and word is spreading about Ampligen. This is an excellent article on ME/CFS. Some highlights below

I like this take-off on "Don't Cry for Me Argentina" :) in BioWorld
Don’t cry for Ampligen yet: Argentina OKs CFS therapy, Hemispherx U.S. hope alive

Note that the article says Ampligen met its endpoints in its trials - which were not easy endpoints - people had to improve their VO2 Max results, as I remember. I doubt that anyone would try that again.

The FDA turned thumbs-down on the compound in late 2009, although Ampligen met its endpoints in controlled phase IIb and phase III CFS studies. The phase III trial randomized 234 patients to receive Ampligen or placebo, and Ampligen patients showed a 17.7 percent improvement in mean treadmill exercise duration compared to a 4.3 percent improvement in the placebo group. The phase III experiment took about six years to complete, and the new drug application filing took another three years, followed by two years of review punctuated by numerous requests from the FDA for more information. (See BioWorld Today, May 4, 2004, Oct. 12, 2007, and Dec. 3, 2009.)

Equels said doctors in Argentina who saw results really pushed for the drug; its a different situation in the US!

The regulatory procedure in Argentina moved at a brisk pace, all things considered, Equels said, as the ship there seems to be steered mainly by physicians who, upon seeing efficacy and a reasonable tolerability profile, push for approval. “I’m just speculating on that, but I’m grateful that they took it seriously and moved quickly,” he said. In the U.S., “we’re still dealing with the fact that there is no clear diagnostic test,” and doctors typically come around to naming CFS as the culprit only after excluding other disorders that might be responsible for the symptoms, which include not only debilitating exhaustion but also such problems as sore throat, muscle pain, and enlarged lymph nodes, along with loss of memory and concentration.

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