Ampligen for Chronic Fatigue Syndrome: Company CEO Comments

A week after we were supposed to have an FDA decision on Ampligen (poly I: poly C12U) for chronic fatigue syndrome (CFS or ME/CFS), there's still no word on what the decision is or when we might know.

Early last week, I corresponded with someone at the FDA, who told me the agency can't legally comment on pending applications. Ampligen's manufacturer, Hemispherx Biopharma, hasn't released any new timetables, which likely means the FDA hasn't given it one. However, a few days ago the CEO of Hemispherx, Dr. William Carter, gave an interview to BioMedReports in which he said that 80% of applications that reach this point are approved. Of course, he has to sound hopeful -- he's got investors who are awaiting the news as anxiously as we are!

If Ampligen is approved, it'll be a huge boon for Hemispherx. In the interview, Dr. Carter talked about the benefits of being essentially the only game in town. He's also confident that it would be a lonely playing field for quite some time, saying:

"If this was cancer or HIV disease maybe you could [get a new drug on the market] in 4 or 8 years, but a chronic disease like chronic fatigue syndrome I think realistically, even in the best of hands where you have all the resources you need professionally and economically it's gonna take you better than 10 years, maybe 15 years, 'cause you have to go through so many clinical hoops to determine whether your drug may be safe and effective."

That's a pretty sobering thought -- I guess we'd better hope Ampligen is pretty good (as well as continuing to explore existing drugs, complementary/alternative treatments, etc.)

Dr. Carter also had some interesting comments on the nature of ME/CFS, which appear to support both older and emerging research:

"Whatever the ultimate cause of chronic fatigue syndrome may or may not be, we know that the majority of patients with chronic fatigue syndrome do have deficits in their immunology. Specifically they have problems with something called the natural killer cell. They also have problems with producing energy. . . . Their mitochondria don't [seem to] work well.

Meanwhile, Japanese researchers are publishing promising data on intranasal (by nose) Ampligen as a way to help the body use flu vaccines more efficiently. So far, data look promising.

The one thing no one is saying about Ampligen is when we'll know the FDA's decision. Keep checking back -- I'll post an update here as soon as I can.

Suggested Reading:

• Learn About Ampligen
• Drugs for Chronic Fatigue Syndrome
• Supplements for Chronic Fatigue Syndrome