Discussion in 'Fibromyalgia Main Forum' started by cfsgeorge, May 12, 2009.
But since the 25th is a holiday it should be announced by the 22nd
what is this?
Ampligen (AMPLIfied GENetic activity) is an antiviral and immunomodulatory drug developed by Hemispherx in the late 1980s. Its primary proposed use is in the treatment of chronic fatigue syndrome (ME/CFS). The drug is officially available for the treatment of ME/CFS in some countries including Belgium and Canada under special usage drug laws. The drug's developers have recently applied for new drug licences in the US and UK for the use of Ampligen in ME/CFS but these have yet to be granted (Oct 2008).
To date trials of Ampligen for the treatment of chronic fatigue syndrome are thought to have included more than 1,200 patients and a total of approximately 90,000 doses of the drug. Ampligen is currently given intravenously and is generally administered twice weekly for periods of one year or greater. An oral form of the drug may become available in the future. A significant number of patients in the chronic fatigue syndrome trials have reported a complete or partial recovery but more common treatment outcomes appear to be improved cognitive skills, an increase in energy, and greater oxygen uptake.
It has not been proven conclusively how Ampligen works in chronic fatigue syndrome but it is thought to involve both the RNase L pathway and Toll-like receptors.
RNase L is an enzyme system in the immune system involved with defence against viruses. In chronic fatigue syndrome it appears that RNase L remains chronically upregulated which results in the symptoms of the disease. Ampligen may act to restore RNase L activity to normal and allow the body to fight off the triggering infection and return to normal function.
According to Hemispherx Ampligen also stimulates type 3 Toll-like receptors (TLR-3). In a statement they say: "The biologic properties of Ampligen are conveyed exclusively by a unique naturally occurring receptor on the cell surface called “TLR-3.” Toll-like receptors (or “TLRs”) such as TLR-3 serve as “pattern recognition” receptors in the early detection of pathogens and the establishment of early defense mechanisms (innate immunity). As such, they are critical to the first line of immunological defense against a broad range of pathogens, such as otherwise lethal viruses and even various forms of cancer.
When the dormant alarm signals of TLRs are activated (as by exposure to a pathogen or a stimulant agent such as Ampligen), TLRs in effect cause an overreaction, driving the body to proliferate broad-spectrum defenses against many types of pathogens."
Ampligen may also increase natural killer (NK) cell activity. NK cells are an important component of the immune system and are consistently found to be low in number and activity in ME/CFS patients.
Some studies suggest that Ampligen is most effective against a certain subset of chronic fatigue syndrome, those with the most severe debilitation who may be entirely incapacitated and bed-ridden. Dr Paul Cheney, a prominent ME/CFS specialist has held high hopes for Ampligen since the early 1990s. He has said that in his experience the chances of successful treatment with Ampligen appear to be "2 chances in 3 and that might be raised a little bit if one targets a subset of patients, specifically ones that are within the first 5 years of their illness who have abrupt onset and who may have activation of this RNase L pathway."
Can't wait to hear about Ampligen - I've been checking the internet every day for news.
I remember when they changed the date from Feb 25 to May 25, it was announced about a month before the Feb 25 deadline.
If it is approved - I wonder how long until we can actually get it, in regards to manufacturing and distribution...
Me too! A decision could come any day...
The co. released more stock a couple of days ago, some interpreted that as a good sign.
They have a manufacturing facility set up but I have no idea how long it would take for them to get it out if it's approved.
This stuff is very, very expensive. And Dr. Cheney would not recommend it any longer. His former partner Dr. Lapp (I used to see him) still does.
Just what little I know.
(I wish I knew how expensive but I don't)
Dr. Lapp's office is one of the study sites, but Dr. Cheney's isn't.
If Ampligen is approved then it's more likely to be covered by insurance.
I don't know if it'll help me or that i will even want to take it. However, I see 2 big things with the ampligen approval. One is to shut the mouths of ignorant doctors, psychiatrist, scientists, policy makers, UK, reeves, and any body else that said this disease is all mental. I can now print it out and mail it to some ignorant dr's who made me worse especially that psycho one dr huang who says there is no such thing as CFS only chronic fatigue. It will stop doctors from mis-diagnosing and randomly prescribing meds not intended for CFS. A/D's=puke!
Second, the monies, researchers, treatment and drug development will be better utilized in the search and treatment of CFS as a physical disease related to the immune system and the systems interconnected to it. We can stop the wa$te esp in the p$ych department, shut-up ignorant mouths in the UK, concentrate and work as a worldwide team to defeat CFS.
This is why Ampligen must be approved. It's been 20years in the making and i don't see another drug in the horizon for CFS. This one drug's approval will do more for the future of CFS than anyone or anything ever written in the last 20years. It will be our validation and our biggest CFS advocate. No one can wait another 20 years...........
That it will legitimize the diagnosis, get the shrinks out of the CFS business, and will interest drug manufacturers, mainstream researchers etc. But it will also treat the segment of people w/ CFS who have HHV-6. It's been effective in trials and is non-toxic: the problem w/ other HHV-6 treatments is the toxicity. According to Wisconsin Lab 40-70% of people w/ CFS have HHV-6. Ampligen is also an immune modulator so would help those w/ immune dysfunction.
I can't see one negative thing about this drug getting approved. If it only gets an "approvable" I will be definitely be getting myself into a trial-I've wasted enough time with this bs disease.
ampligen seems pretty safe, but it has a very high price, it's invasive(IV), and its efficacy is not that good IMPO. on average, PWC who took ampligen by IV 2X/week for 6 months only improved their treadmill times by a couple minutes if i recall correctly. It'll do wonders for those who are bedbound with very severe cfs. Getting them back onto their feets must feel like a miracle. But for someone like me who can walk up to 20min continuously on a good day, just adding a couple more minutes for the cost and hassle of the iv treatment may not be justified for ME.
The main things the fda will be looking at are its safety, efficacy, and cost effectiveness. I think it'll be approved. It would have been approved a long time ago if this was a US pharmaceutical company with their lobbying powers.
At this point, it's not about the drug, but its bigger implications on CFS as a whole as you pointed out in your first sentence.
The problem that Hemispherx has is that the CDC definition says nothing re: viruses, although all of the specialists know that they are an issue. Therefore Hemispherx cannot show improvement of viral levels as part of their evidence for drug approval. I believe that what's happening is that those w/o viral infections are not getting all that much improvement, while those w/ viral infections are, and so it's averaging out to be a modest (although statistically significant) improvement for everyone. More importantly though, people decrease use of other drugs w/ Ampligen treatment, which indicates that it is effective and may ultimately cost insurance co.s less. They have also been working on an oral version for awhile now-would assume that if the IV were approved that they would be able to get the pill form finalized.
I think that the reason that it hasn't been approved before is b/c the CDC would not admit that CFS was a serious illness that did indeed exist-they finally did in 2006 w/ their "Awareness Campaign". It's difficult to get a drug approved for an illness if the govt. does not think that it is legitimate. Hemispherx is also a small co. w/o a lot of clout in DC-they are a US co. though-based in Philadelphia.
This drug will ultimately help everyone w/ CFS, but for those of us w/ viral-induced CFS this could be a lifesaver. If you check out Mary Schweitzer's (advocate, former professor) blog you can see what a difference Ampligen made in her life.
I didn't know who was out of their minds when i read your post. Ok, i'm out of my mind and you proved it. I've been reading up on ampligen for a year and always saw phillipines instead of philadelphia. i can't believe it. This is what i told my doctors, family and friends. just a mistake? no, not for me. physically i'm better, but cognitively i'm worse than 1 year ago. my brain fog has turned into extreme lightheadedness and dizziness. I use to be so smart, sharp and never made mistakes, but my memory is so bad now. i can't read a book and write you a book report because i've forgotten. I can't watch a movie and remember it the next day. It's always a new movie for me every few days. I'm sorry i digressed, but i had to let it out when i read philadelphia on their website. :=(
Back to the matter at hand, the CDC really needs to get their act together. Which studies have they funded that made any real contributions to the CFS community? Please post. Are we any closer than we were 10 or 20 years ago? The information is overwhelming, contradictory and reads like everything is going in circles over and over again. kinda sad ain't it? We really need something now to kick CFS research into high gear and into the proper lane. We need Ampligen approved.
I know where you're coming from-I had a relapse 5 years and my brain was just erased-I couldn't even read at one point-it was terrifying. It's improved significantly though-I think that the Valcyte really helped.
re: CDC-you can speak at the CFSAC meeting on May 27-28 and rant about the CDC-that's what I'm planning to do. There's another thread w/ the details posted by Quayman.
YES, we need Ampligen APPROVED
cfsgeorge - I'm with you on the cognitive dysfunction and memory impairment - I could swear I read one thing and then go back and re-look at it later and it's different Arrghh!
outofstep - you always keep me thinking, great point that it's difficult to get a drug approved for an illness that the gov't doesn't admit is legitimate, and to not include viruses as part of the CDC CFS definition and then to approve Ampligen doesn't really make any sense...
BTW - I thought Cheney did do an Ampligen study at his site? It is concerning that he doesn't include it in his protocal today... it would seem then that the study did not go well.
[This Message was Edited on 05/13/2009]
The thing w/ the Ampligen is that it does show improvement using the CDC's definition-the drug co. just don't explain why there is improvement. I'd say it's b/c it's an antiviral/immune modulator and is suppressing viruses/making the immune system run correctly-but they can't say that since the CDC won't acknowledge the viruses or the immune dysfunction. You're right-it's nuts. But technically, if it's safe & effective then the CDC should approve it. But who knows with those people...
There were only 3 study sites in this last trial-Lapp, Bateman & Peterson, so that's why Lapp and those guys have been using it. Cheney has used it in the past, and has had good things to say re: use with the subset of people w/ abrupt onset and activated RNaseL pathway in the first 5 years of illness. The only criticism I've read from him is re: cost (and that should go down w/ increased volume) and high relapse rate after stopping treatment.
And Cheney didn't seem to like the side effects. Well, to each his own. Let's see bedfast/housebound or side effects. That is a tough one.
I know this is off topic but I would like to address the insurance premiums of small businesses.
Yes, I could get it paid for by insurance. Then my husband's company's insurance premiums would be out of reach for some of the employees. The "boss" (although my husband is called a "partner" only one person has the real control) could do something for the people with insurance premium woes but he refuses.
Well, it is more than that. Another partner whose wealthy family could well pay for his family's enormous medical bills out of pocket and save the premiums of the "staff", won't. But he does buy everyone in the office a $30 meal ticket to a restaurant each year. Way to go.
So, I am stuck. Literally...more and more in the house as I spiral downhill.
Hmm. Things to think about.
I'd be curious to hear what Cheney's criticism was since the side-effects don't sound any different from what you get with any other antiviral. I figure if Peterson is using it then it's legit.
According to the drug co., the high cost is related to low volume, so if they were producing more then the cost would go down, in theory, so don't give up on it yet
Was the patient who committed suicide. She had CFS, had gotten pretty stable but wanted to be better. I don't know that she was able to work. She took the Ampligen and started having uncontrollable migraines so bad that she ended her life. Her mother said the daughter was a very brave woman.
I read that account in a CFIDS Journal years ago.
just want to clarify that for people who may be interested in it.
The initial trial (when that poor woman committed suicide) was 91-92. Cheney continued participating in trials after the first one. He was still using Ampligen to treat patients in the late 90s. I do not know if he did actually stop using it, and if so when and why. If you could come up with a link to something spacee that would be great. I do know that he changed his treatments after his heart attack.
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