Chronic Fatigue Syndrome Treatment - Will Ampligen Finally Be Approved?
New Drugs of 2009 Series: Ampligen
While millions of people with chronic fatigue syndrome (CFS or ME/CFS) have waited decades for better treatments, a drug called Ampligen (poly I: poly C12U) has languished in the "experimental" stage for 30 years.
Then, in October 2007, Ampligen's manufacturer, Hemispherex Biopharma Inc., put in a New Drug Application for Ampligen as the first ever FDA approved treatment for ME/CFS. In July, the company responded to questions sent back by the FDA, and the application was officially accepted. Now, it's just a matter of time before we hear yea or nay. The decision should be out sometime this year.
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 certain types of cancer, AIDS, and avian flu.
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%. A lot of seriously disabled people have even been able to go back to work because of it, they say. Side effects are reportedly mild, and oddly enough 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, from Hemispherex Biopharma
Personally, I think if Ampligen is approved it will be huge for ME/CFS in a couple of ways. Of course, we desperately need better medications. But it would also likely mean more public service announcements and lots of publicity, which could lead to better public education and understanding - which we need almost as much as we need treatments.
What do you think Ampligen's approval would mean? Do you want to try it? I'd love to hear personal experiences from people who've taken it! Share your opinions and experiences here or in About.com's Fibromyalgia & Chronic Fatigue Syndrome community forum (You'll find good comments in both places!)
Suggested Reading:
- Learn More About Ampligen
- Chronic Fatigue Syndrome Treatment Options
- Drug Treatments for Chronic Fatigue Syndrome
- Supplements for Chronic Fatigue Syndrome
Photo © Sheer Photo, Inc./Getty Images
Comments
I was a participant (more like a victim) in an FDA
Phase III drug trial for Ampligen in San Diego CA from 1999-2000. Many of us got ill
from Ampligen in that study; however, we were listed as drop-outs with no mention of
the severe adverse effects of Ampligen. That Ph. III trial was poorly run and a
virtual sham – the supervising M.D. refused to listen or record any negative data
(there was plenty). The methodology was terrible in that medical oversight and
record keeping was superficial and important questions were not asked. During
subsequent contacts with the FDA and various CFIDS organization on this matter, it
was clear that few or none (most certainly the FDA) did not want to hear any
negative data about Ampligen – thus the significant adverse effects of Ampligen were
buried, not recorded, and ignored.
John,
Thanks so much for your comment! It seems like every about-to-be-approved drug is regarded as the miracle that everyone has been waiting for, and then the reality of it can range from disappointing to terrifying. I hope a lot of people take your experience into consideration.
This is the sort of news that i search the internet for every day with out having any success. It gives people like me alot of hope that one day we can live normal or at least some normal life the rest of people. I of course have read the comment about the side effects of this drug, but still I’m remaining hopeful.
Thank you for posting this great news, hopefully more good news like this will follow
It’s unfortunate that John Chavez had a bad experience with Ampligen, but I have read his complaints elsewhere and he seems to be on a crusade to discredit a drug that has been incredibly beneficial to other people. If it doesn’t work for me then okay, I’ve tried every other drug that’s come along, suffered the side-effects, and have then moved on. I have everything to gain if this drug is effective, and I and a large number of my fellow CFS sufferers want and deserve the chance to try it for ourselves.
John’s experience sadly is not untypical for trials with big pharma drugs. Failed trials are often buried. It will be hard to trust almost anything they come out with especially at first.
The other problem is that within CFS there are many subgroups that tend to repsond differently to various treatments, supplements etc. so that will be a challenge. I can understand someone with such a negative experience to be vocal about it and it may still help others. But having said that, I don’t trust what the drug companies say – they lie in order to make big money.