Ampligen study published in PLoS One 14mar2012

[Firestormm]

I thought it was a good analysis from Research 1st: http://www.research1st.com/2012/03/21/ampligen-on-trial/

 

[satoshikasumi]

I feel that Vernon was overly stuck on the lack of subjective improvement in Karnofsky and SF-36 scores in the Ampligen group. The trouble is, these scales were designed for diseases other than CFS and are generally very poor estimates of function in this disease. It would have been better if the study had used the CFS symptom inventory in addition to these very vague measures of general health.

The objective measures indicated that Ampligen did work. Why would patients getting the real drug reduce their use of medications to treat symptoms like pain and sleep disturbance more than the placebo group if it weren't really improving their symptoms?

 

[WillowJ]

I've heard concerns before about using saline infusions as a placebo in ME/CFS trials as it might help patients. I don't know if we can tell much from this? But it would have been interesting if they had a "no treatment group" (although distinguishing what were the effects from saline as opposed to placebo effects might be hard. Maybe one could simply have a non-saline/water infusion? Although again, some might feel that would help with blood volume issues.

this is an important concern, and I agree that it would be nice to have some other kind of placebo, in light of the low blood volume problems PWME tend to have.

But in a medicine delivered by IV, there is no way to accomplish blinding without using normal saline in another group. The reason for the saline is that it's configured to be the same osmolarity as blood plasma (this solution as mixed for medical use is called "normal" saline); this is why it is used as an inert.

It would be frowned upon to use water, because the osmolarity is different, and that wouldn't and couldn't be a placebo. I'm not sure whether it would be safe as measured in a syringe--but water would certainly not be safe in any significant volume (not sure how much volume is needed for ampligen; I didn't read the study).

Maybe there could be a treatment group, a saline group for blinding, some other kind of placebo (maybe relaxation therapy?), and a non-treatment group as Dolphin mentioned, to help sort out how much was placebo response (if any; not too much of that in us as we may no longer expect treatments to work) and how much was blood volume replacement.

 

[Kati]

With all due respect, it would be a waste of my time to participate in such trial, especially considering that the drug arm gets the same amount of NS as the control group and same rate.

Perhaps it should be stipulated in the clinical trial design that total amount of IV fluid received, during and in between treatment should be documented and assessed for significance. There should also be a guideline stipulating that the use of IV fluid should not be routine and given only when absolutely neessary and perhaps patients already receiving IV fluids as supportive measure should be excluded from the trial unless willing to forego without it.

 

[satoshikasumi]

The Vanderbilt autonomic function study is handling this issue nicely. They are trying to test whether saline does, in fact, improve CFS symptoms.

Their placebo? sham saline. This means that patients are hooked up to an IV and given a small amount of fluid but the bag they are hooked up to is actually a machine that is designed to fool them into making it *look* like a big bag of saline is being infused into their bodies.

Maybe sham saline should be the standard for all future CFS studies? In my opinion, this isn't really a concern because the amount of fluid in an Ampligen bottle is pretty small. I believe you need more than a half-liter of saline infused in a short period of time to get a response in CFS patients..

 

[biophile]

satoshikasumi wrote: Why would patients getting the real drug reduce their use of medications to treat symptoms like pain and sleep disturbance more than the placebo group if it weren't really improving their symptoms?

A possibility which comes to mind is the Ampligen making someone more sensitive to the adverse effects of medications.

 

[Snow Leopard]

I don't get it, why is there so little media coverage of this article.

Media Coverage of This Article
Posted by PLoS_ONE_Group on 23 Mar 2012 at 20:21 GMT

 

[WillowJ]

I don't get it, why is there so little media coverage of this article.

Media Coverage of This Article
Posted by PLoS_ONE_Group on 23 Mar 2012 at 20:21 GMT

http://chronicfatigue.about.com/b/2...onic-fatigue-syndrome-trial-data-released.htm

http://www.benzinga.com/trading-ide...ngas-microcap-movers-for-monday-march-19-2012

http://www.marketwatch.com/story/he...nr-in-chronic-fatigue-syndrome-cfs-2012-03-19

http://www.prohealth.com/library/showarticle.cfm?libid=16876

http://finance.yahoo.com/news/hemispherx-publishes-data-bioactivity-ampligen-123000903.html

yes, other than Adrienne Dellwo's about pages and ProHealth which predictably cover anything related to us, only a few stock pieces, no general or medical news that I can find. Maybe everyone else is burned out on the story.

 

[dannybex]

By the way DannyBex. I will never trust NCF and to the extent their lobbying against the approval of Ampligen has been effective, I will never forgive them. They will never be relevant in the CFS advocacy movement.

I'm in no way a fan of the NCF, who by the way, sent out notices in 2006 I think it was, claiming they had found "the" cause for CFS. You're right, they're not relevant in any way -- especially when they spend 90% of their "energy" bashing any organization, person, research or protocol that they didn't fund. I just found that article via google, and it happened to be on their site.

That's great if Ampligen worked for you and you're willing to spend the $$. It's my understanding that there are currently open trials in 4-5 different locations around the country that are looking for patients...?

I think there's another thread on the forums discussing these trials.

 

[Kati]

Here is why it's not getting attention: it's not sponsored by the Wellcome Trust, Simon Wessley or his friends.

 

[Firestormm]

I would suggest it isn't getting attention because it isn't a new trial. The data was provided in 2004 and has been re-represented. Nothing I can see is wrong with that of course and it does appear to satisfy the FDA's ET requirement.

Also, only when they move onto a new trial and/or seek and receive marketing approval will it be 'news' in the sense of headlines I think. From the coverage and analysis thus far it would seem one stumbling block is potentially the lack of a 300 person trial.

There's also the arguable fact that the ET results shown in this publication are perhaps not all that impressive. Personally I would like to have seen/heard about why Ampligen is apparently effective in patients with CFS. What is it that the drug does? I think patients should have undergone some immune profiling before and after to better establish the efficacy of the drug.

 

[satoshikasumi]

This article has a decent analysis of the current position of Hemispherx:

http://www.smallcapnetwork.com/Is-H...e-Tunnel/s/via/10/article/view/p/mid/2/id/83/

The phase II study did use an immune biomarker, but this was dropped from phase III. The silly thing about Hemispherx and Chronix partnering to find a biomarker that correlates with response to Ampligen is that they've had one for years.

It just happens to be an esoteric test that never caught on with the mainstream researchers, for no good reason. I am talking about the abnormal 37 kilodalton low molecular weight form of Rnase-L. As described by Cort in one of the first Phoenix Rising articles, this defect has been replicated by four independent labs (alas, all private labs, not the CDC/NIH/MRC funded) and shown to exist in many CFS patients but it is not found at all in controls. The level of the abnormal protein correlates with symptom severity and disability. And, prolonged treatment with Ampligen completely eliminates the low molecular weight Rnase-L and replaces it with the healthy 80 kilodalton version.

But, in spite of the success and explanatory power of the Rnase-L findings, it has been ignored by the government researchers, and was eventually ignored by Hemispherx. Government-funded researchers have never attempted to replicate the finding. The test is no longer commercially available in the United States- I believe RedLabs/VipDx stopped offering it in 2009.