A lot has happened at the National Institutes of Health recently regarding ME/CFS research, and it’s past due for a round up.
Firstly, in mid October the NIH announced it had awarded seven administrative supplement grants resulting from a Notice of Availability that was issued in April 2016. These enabled NIH-funded projects to expand the collection and analysis of biospecimens from individuals with ME/CFS to aid in biomarker identification and help identify potential therapeutic targets.
It’s not clear how much was awarded, although we do know these were not large grants; Cort Johnson reported they were around $100,000 each. (More details about the awarded supplements and who they were awarded to are available here under “Funded Projects”. Some of the descriptions may be about the original research and not the grant supplements.)
Columbia CII was awarded a supplement grant, which will help identify past infections in ME/CFS patients, including novel pathogens not seen before in this illness, or perhaps even not seen before in humans. Dr. Lipkin has pioneered the detection of viruses across species some of which he’s shown can cross into humans:
“Multiple findings over the past several years suggest a viral or post-infective connection to ME/CFS. Dr. Lipkin and his colleagues will develop a cutting-edge library containing protein fragments of all known viruses that infect vertebrates, including mammals. Dr. Lipkin’s team will use the protein library to assess blood samples from individuals with ME/CFS and healthy individuals, to identify potential viruses the individuals with ME/CFS have been exposed to and correlate to symptoms of ME/CFS. The results may help advance detection of novel pathogens involved in ME/CFS.”
This project uses smart science to detect viruses. Our immune systems produce antibodies to fight off infections. These antibodies persist even after an infectious agent can no longer be detected. Immunovir is a new diagnostic method for detecting antibodies to all known viruses in blood and other body fluids. This project is using Immunovir to determine whether historical evidence of infection is linked to ME/CFS. Note that this is not to be confused with ‘Immunovir’ the antiviral drug with the same name.
Two RFA’s on the way
Secondly, on October the 21st the NIH released a notice of intent to publish a Funding Opportunity Announcement (FOA) for ME/CFS. This provided advance notice that there will be two Requests for Applications (RFA’s) issued in December 2016, giving researchers the maximum time to prepare. The first RFA is funding for Collaborative Research Centers (CRC’s):
“The overarching goal of this initiative will be to establish a network of Centers that will work independently and collaboratively to define the causes of and discover improved treatments for ME/CFS. The purpose of the ME/CFS CRC research program is to facilitate research in ME/CFS through support of:
1) collaborative basic and clinical research on ME/CFS, including longitudinal studies of individuals with ME/CFS within each ME/CFS CRC and across CRCs within the network;
2) foster early stage basic and clinical investigators in ME/CFS research; and
3) provide access to information related to ME/CFS for basic and clinical researchers, academic and practicing physicians, healthcare professionals, individuals with ME/CFS, and the lay public.”
The other RFA is for a Data Management and Coordinating Center (DMCC) to “facilitate and coordinate research in the Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Collaborative Research Centers (ME/CFS CRC)”.
It is not known how much funding will be available through these RFAs for actual research, as opposed to center running costs. Also the due date for the applications is April 2017 and the awarding of any funding from this mechanism would not be earlier than September 2017.
An NIH ME/CFS Advocacy call with the community was held on November the 2nd which included Dr. Walter Koroshetz, Dr. Vicky Whittemore, Dr. Joseph Breen, Dr. Avindra Nath and Marian Emr. There was some excellent questions and comments from our patient community’s advocates: check out the recording and transcript.
Funding increase announced
‘NIH to double funding for chronic fatigue syndrome, but patient distrust remains’ said a Science article by Meredith Wadman on November the 10th. The article stated that research funding for ME/CFS should rise in 2017 up to roughly $15 Million. Do read the article: Dr. Vicky Whittemore was quoted as saying at the recent IACFS/ME conference “There is a shifting tide at NIH with regard to ME/CFS”.
It is not clear if the $15m includes the pending RFAs or the cost of the NIH in-house intramural research study headed by Dr. Avindra Nath.
Dr. Lipkin and other researchers, as well as advocate Deborah Waroff, were interviewed for the piece. The grant awarded to Drs. Lipkin and Hornig highlighted in this article is not new funding: it has helped partly fund the collection of samples for the huge study the Microbe Discovery Project is fundraising for. The article also mentioned a metabolomic study from CII:
“A study published in the Proceedings of the National Academy of Sciences in August found depressed blood levels of scores of metabolites in people with the disease compared with healthy controls, suggesting that the disease may push the body into a low-energy state some have compared with hibernation. Scientists and patients are eagerly waiting for the results of a similar study by Lipkin’s team. If replicated, the tantalizing finding could fit with an emerging theory that subpar function by mitochondria, the organelles that provide energy for cells, drives the disease.”
This is the Chronic Fatigue Initiative funded research cohort of 200 ME/CFS cases and 200 controls that Drs. Lipkin and Hornig have been working on for quite some time, which includes metabolomics, as detailed on our home page. We have been excited about this research for a long time. We are very eager for the results, even more so due to recent publishing and reports in this area of research for ME/CFS.
What does this all mean?
Firstly, our patient MDP team feels we need to give credit where it’s due. NIH director Francis Collins, with Dr. Whittemore’s steering of the ship is showing real progress for ME/CFS, even if the $15m is a lot less than many had hoped for. However, there will be a big sense of deflation for all of us if the RFAs to come in December are not large enough to give ME/CFS research the tangible boost it needs.
There is a sense of nervous uncertainty about how much the RFAs research Centers will be worth as Jennie Spotila’s blog sets out. We cannot let up in battling for funding that matches with the huge disease burden. Drs. Lipkin and Hornig both advocate for targeting congressional leaders. Dr. Hornig has stated “grow that effort” with respect to recent good work our community made in this area when she spoke at the New York #MEAction protest.
The recent announcements are good news for Columbia CII. Together with other researchers and ME/CFS specialist clinician collaborators they have worked hard for a long time to lay strong ground-work for a research Center of Excellence. They are doing everything they can to get funds from existing mechanisms and to be ready to apply for funds under the new RFAs when they come.
We are in this together with Columbia CII
In trying to reach the end goal total of $5 Million CII need we are in this together with CII. The whole point is to help them get over the funding finish line so that they can do quality research. This excellent team have a history of being able to secure grant awards but it is never guaranteed, and unlikely even then to cover the full amount needed.
Imagine if, together, globally, we managed to raise even $2.5 Million of the $5 Million CII need for this research. This would make that funding finish line so much closer for CII. We don’t have to sit back and wait, we can take control by funding research now.
Thank you for sticking with us!
Our MDP patient-led team is in for the long haul. The CII’s huge planned study is designed in magnitude and depth to tease out patient subgroups and pin down which physiological pathways have gone wrong in patients. The study will gain a massive amount of information and data.
The research involves looking into the Microbiome (viruses, bacteria, fungi) of the gut and the throat, metabolomics, proteomics, immunology, genetics and epigenetics on a robust number of exceptionally well characterized patients and controls.
It would be amazing if there were some matching donors to help support fundraising efforts. If anyone out there is considering this and would like to talk to the CII team please contact Fern Shwartz at firstname.lastname@example.org
Thank you so much to everyone for your donations and continued support.