Will the millions of people with chronic fatigue syndrome (CFS or ME/CFS) finally have an FDA-approved drug treatment? We should know soon, as the long-awaited decision on Ampligen (poly I: poly C12U) is due on or around May 25.
Ampligen has languished in the "experimental" stage for 30 years. Then, in October 2007, Hemispherex Biopharma Inc. put in a New Drug Application for Ampligen as the first ever FDA approved treatment for ME/CFS. In July 2008, the company responded to questions sent back by the FDA, and the application was officially accepted. The decision was originally due in late February, but the FDA at that time announced it needed 3 more months. Now, it's just a matter of time before we hear yea or nay.
Ampligen is an immume-system modulator that works by jump-starting your body's natural anti-viral pathway and regulating levels of Rnase L (a substance in your cells that attacks viruses), which can be high in people with ME/CFS. Studies show it's more effective and has far fewer side effects than other drugs in its class. Ampligen has also been studied as a possible treatment for AIDS, avian flu, and certain types of cancer.
This drug has been available to certain U.S. clinics for several years, and there's a lot of evidence (both clinical and experiential) showing that it works. Some doctors claim they've seen improvement in 80% of people with ME/CFS who take Ampligen, and significant improvement in about 50%. They say a lot of seriously disabled people have even been able to go back to work because of it.
Side effects are reportedly mild and include flu-like symptoms, dizziness and confusion. (After living with ME/CFS, would you even recognize those as side effects?)
Here's more info from the manufacturer: Ampligen.
Suggested Reading:
- Chronic Fatigue Syndrome Treatment Options
- Drug Treatments for Chronic Fatigue Syndrome
- Supplements for Chronic Fatigue Syndrome
Photo © Sheer Photo, Inc./Getty Images
What great news!
These results look more encouraging than the last ones I saw.
Any word on current cost? Last I heard was to be about $40,000 / yr which inc’d MD visits, lab tests and drug.
Also any chance Medicare will cover better than teir?3 or 4? where we have to pay about 66% of the cost? PLEASE POST ON THE FORUM. THANKS.
Studies have not shown that Ampligen is more effective or better tolerated for CFS/ME than other immunomodulators, because it has not been compared to any of them! But low dose naltrexone, while it may or may not be more effective, is certainly much better tolerated than Ampligen. I cannot understand why you constantly make unsupported claims on this site.
Regards,
Maija Haavisto, author of Reviving the Broken Marionette: Treatments for CFS/ME and Fibromyalgia
Maija,
It’s not an unsupported claim. If you compare studies of Ampligen to similar studies of other immunomodulators, it’s pretty clear that the side effects are more mild. Fewer are reported, and fewer people leave the studies because of them. It’s almost unheard of for drugs to be compared within a study, unfortunately, so this kind of data is all we have to go on before a drug is on the market and widely used.
Low-dose naltrexone certainly shows a lot of promise in clinic use for chronic fatigue syndrome, and in initial studies for fibromyalgia. However, it has yet to go through clinical trials for chronic fatigue syndrome, so any claims made about it are purely anecdotal.
Hi Adrienne! Thank´s for yout report! Will you report us here as soon the an FDA-decision is known? Thanks, and kind regards
Another 1-2 weeks now apparently due to “staff scheduling changes which might (or might not) delay the report”: http://www.hemispherx.net/content/investor/default.asp?goto=631
I am as you might guess nervous enough about the CFSAC meetings without also having the Ampligen decision hanging over my head. I was on Ampligen for 7 1/2 years out of the past decade – lost it 15 months ago and am still going downhill since crashing on Labor Day.
I had to pay $20,000/year to get it, but I had all three markers we knew responded to it – HHV-6, 37kDa Rnase-L FacTor, and low natural killer cell function (CDC specifically lists all three tests as unwarranted for CFS …)
You might want to look at the Ampligen Diaries I kept for the first six months I was on it back in 1999:
I’d skip the overlong intro (blush) and head straight to February if it were me.
SIGH.
Mary Schweitzer