Basic research and drug trials under discussion at the NIH
In October, the National Institutes of Health (NIH) announced it was stepping up its commitment to ME/CFS and would be expanding its intramural and extramural research programs. Francis Collins, director of the NIH, told Science that his colleagues were “determined to move pretty fast on this.” He asked the public to “give us a chance to prove we’re serious, because we are.”
The first step in their plan is a clinical study, to be announced after the New Year, involving a cohort of patients who became sick after an “acute, febrile illness.” The Trans-NIH Working Group, headed by Walter Koroshetz of the National Institute of Neurological Disorders and Stroke (NINDS), is in the process of drafting a plan for both that study and for research priorities for the illness as a whole.
In a recent interview, Collins described the range of possibilities under discussion. “They’re talking about everything from basic science – the metabolome, microbiome, immune system, imaging – to clinical trials for promising approaches, including Ampligen and Rituximab,” Dr. Collins said.
When asked about extramural research funding, Dr. Collins said he couldn’t yet specify a number as the Working Group is still devising a research strategy. But he emphasized their commitment to increasing funding. “We’re saying that ME/CFS is a program priority now.”
12 thoughts on “NIH considering Ampligen and Rituximab trials”
Hi Julie. The Rituximab and Ampligen references in the article, do you have a link for that interview? It’s not in the Science article, but I vaguely remember reading it somewhere. Thanks in advance.
It was an interview I did with him.
The day you posted this news (21 December 2015) was my 15-year ‘ill-iversary’ of being very severely affected with M.E. Drug trials are extremely welcome and good news, if they come to fruition. ? I’ll keep my fingers crossed!
I became ill in 1984. I thought for many years that I had ME and even when I heard of Post Polio Syndrome and I knew that I had had polio as a child, my symptoms were so much like ME that I still thought that I had ME. I have now accepted that I have post polio syndrome but either most of the symptoms are identical to ME or I have ME as well as PPS. Clearly if polio was the cause of my ME then PPS should be being investigated in the same way as ME and it might even inform the research. I do hope that this new research if successful in finding a remedy for the symptoms of ME will also help me too.
It’s really nice to know that research will be stepped up but Ampligen and especially Rituximab are not the answers IMHO. Both are costly risky drugs that do nothing to reverse or repair the disease process. The hoopla surrounding Rituximab is particularly confounding.
Those who have been following the Rituximab story know that it could very well be the answer for subgroup. Some patients responded remarkably well and experienced a sustained remission of symptoms. Others experienced a remission but eventually relapsed. In a subgroup of patients currently diagnosed with ME or CFS, the cure may be as simple as breaking a vicious cycle of self-perpetuating B cells involved in the production of autoantibodies.
I’m not holding out too much hope for Ritux. Only 2 out of 12 on the Phoenix Rising forums have benefited from it, the rest got worse.
On the other hand, folinic acid was shown to improve CFS symptoms in a group with B-cell immunodeficiency:
http://www.ncbi.nlm.nih.gov/pubmed/16889122
Ritux has around 13 generics/analogues being created due to the patent being expired except in the States . for the states there are two or three that have a method of action that is just different enough to dodge the patent so expect ritux to plummet in price on not too long. Does your country subsidise drugs if they are known to really help a condition ? Here in Australia for example ritux is currently 2030 dollars per infusion for general use but for recognised conditions like rheumatoid arthritis its only $30!
To me the outcome is the most important factor in deciding to take the drug rather than it addressing the root cause ( which it still might be) – the initial studies have been finished 5 years with those who got significant improvement having them remain to this day so even if we are pessimistic someone living to 100 would have 6 weekly treatments for 2 years with gaps of 5 years. I have no doubt this will improve because they are just beginning to play with dosage amount and frequency
I know of no one who has remained symptom free for more than a year. Not sure where you’re getting this 5-year ‘remission’ statistic Tim. If you have a link to proof of this please post it.
I would like to see a trial of Xifaxan for ME patients with and without gastro symptoms. Is there any talk of that? I had an extraordinary improvement in my ME symptoms which is documented in Health Rising. Dr. Kogelnik at OMF is now treating SIBO from what I understand and they did a study which I believe may have been based on my experience with Xifaxan and perhaps others’ experience. I’ve heard from a number of ME patients who got better on Xifaxan but were not allowed to stay on it as a maintenance drug. I believe one of them was given it by Dr. Peterson. By a lucky fluke, my insurance company has continued to cover it and I’ve been using it for several years now. My initial experience was that starting and stopping it three times, I got better in a short time going on it and then worse just as quickly going off of it. Recently a small study reported that in ME patients, after exercise, there were increases in multiple types of bad bacteria both in the gut and the bloodstream that were not found in healthy controls. Xifaxan is used continually for HE, Hepatic Encephalopathy. Can we interest the NIH in a clinical trial on Xifaxan? What could make that happen?
Did he give a Timeline on the research strategy?
No, though I got the impression that things are moving quickly.
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