Want to know more about the research centers and data center being planned for ME/CFS by the National Institute of Health (NIH)? Directors at the NIH discussed the research centers and answered questions from people with ME along with researchers in a phone call on Feb. 2.

The NIH will provide $30 million over the next 5 years – or $6 million per year – to fund two to three research centers and a data management center. The goal of the research centers is to create a collaborative process for investigating the cause of and treatment options for ME/CFS.

“We see this as a starting point for increasing the infrastructure necessary to address this complex challenge, and to really build the field up,” said Joseph Breen of the National Institute of Allergy and Infectious Diseases (NIAID) at the NIH, and a representative of the Trans-NIH ME/CFS Working Group. “We want them to be centers of information for clinical researchers, basic researchers, academics, practicing physicians, patients and lay public. We hope these centers will provide real leadership across the country and expertise in this area.”

The data management center will enable researchers across the centers to share data with each other. “The centers program will challenge investigators to come together to design a project that they will do together,” said Walter Koroshetz, director of the National Institute of Neurological Disorders and Stroke (NINDS) and chair of the Trans-NIH ME/CFS Working Group. “A coordinated attack on ME/CFS is really in demand at this time.”

What Case Definition will be used for studies? Where will the centers be located? How does this affect clinical care?

The following two case definitions will be used to identify patients for studies at the research centers: The Canadian Consensus Criteria and the IOM criteria .

The NIH is a research organization and so it doesn’t directly affect clinical care. However, Koroshetz said he expects the research centers will not only enroll patients for research studies but also care for a larger number of people with ME/CFS on the side, although Joseph Breen seemed less certain about this commitment later in the call.

“The sideline expectation is that [research centers] will raise the view of ME/CFS among some of the major hospitals and universities and provide the evidence that will then get back to the doctors and lead to a change in practice,” Koroshetz said. “The centers are mandated to have collaboration with patients and patient advocacy groups. When these begin, the investigators will look for collaborators in the patient community to help with application and research.”

The NIH has not yet determined where the research centers will be located and the locations will be based on the successful applications. Koroshetz assured that once the locations are decided, the NIH will disseminate information about them to nearby hospitals and universities.

Money for the research centers and data center will not replace the typical application process for researchers to apply for grants to study questions involving ME/CFS, which takes place three times per year, assured Koroshetz.

Researchers interested in learning more about the grant application process should attend a webinar for prospective applicants on Feb. 13 at 3 p.m. ET. Visit here for more information.

People with ME posed the following questions on the call:

How do we get out of this catch-22 where there are no clinical trials, no pharmaceutical investment and no FDA-approved drugs? How can we make clinical trials happen now – not in 3-5 years from now?

Koroshetz: Certainly we feel the urgency from the people who are suffering now. This is a constant tension at NIH. We have to think about short-term and long-term and have to be realistic about the chances of success going into clinical trials.

From my experience, failed clinical trials are a disappointment when they don’t show what you hope for. Multiple failed clinical trials can destroy an entire field. For example, with stroke, there were multiple failed trials in the ’90s that stopped the industry from having any interest…

A long-term approach has the best chance of success but it takes a long time. But there may be instances where it makes sense to try something in the short-term, even with limited knowledge of the effects of intervention. It’s tricky to do but we definitely do those because we have a commitment to those suffering now in the short-term. We are always open to bringing this in and putting it in front of peer review.

The [research] center approach is the best one to help build up an army of researchers that will launch successful clinical trials. The centers will help bring in new people to the ME/CFS field, including seasoned clinical trialists.

Although the program itself is not for clinical trials, the RFAs mention explicitly that they want to build a path to clinical trials. That path is open. We just need to grease that path with the knowledge for a successful trial.

Is the NIH doing any research to look at the connection between ME/CFS patients and cancer?

Koroshetz (paraphrased): There are some research grants to look at the connection between immunology and cancer but not many. Those grants are searchable at NIH Reporter.

Is the funding enough?

The NIH will provide $30 million over the next 5 years – or $6 million per year – to fund the 2 to 3 research centers and data management center.

While #MEAction is happy about the establishment of the research centers, the funding falls short of what is needed to really get the science off-the-ground.

“I’m a little worried about the amount of money being put up at the beginning,” said geneticist Ronald Davis, who is helping to lead the End ME/CFS project at the Open Medicine Foundation. “I’m confident I could use 10 times that amount just in our group of people that could very effectively do good research with that amount of money.”

An activist with ME/CFS called the funding levels “a kick in the face.” She called on the NIH to act with urgency and to commit serious funding to the research centers.

“I am alarmed by the lack of urgency and the low level of funding that’s been put forth. I know you’ve worked hard on this, but I’ve been a patient for almost 40 years, and that’s 40 years of my life that have been taken from me by, not the disease, but the inaction of NIH. And I don’t think that I and people like me should be further punished by [NIH] plodding along at a snail’s pace.

Read her full testimony here.

Updates from the Trans-NIH ME/CFS Working Group:

The Common Data Element project and more:

The Trans-NIH ME/CFS Working Group is working on a Common Data Element (CDE) Project for ME/CFS to establish a common language or terminology for investigators to use in their studies of ME/CFS. This is important so that researchers investigating the same problem are using the same terminology to discuss their results.

The CDE project for ME/CFS is comprised of 55 representatives, including researchers, clinicians, patients and advocates. The group has had one training call, and will hold another one in a few weeks. The group will divide into sub-groups to define terms for the various domains of ME/CFS such as post-exertional malaise and sleep dysfunction, etc. Once the CDE has been developed, it will be released to the public for comment.



Progress on the NIH intramural clinical study is being made with the first patient expected to arrive for study in March. Several healthy controls have already come in and five patients have been identified thus far for the study. The NIH intramural clinical study is examining the clinical and biological characteristics of the disorder to gain understanding of its cause and progression. Read more here .



The NIH has plans to “talk about ME/CFS at meetings where it might not have been discussed previously,” said Koroshetz. NIAID is hosting a half-day session called “Insights into the Immunology of ME/CFS” at a conference on June 14th in Chicago, and have invited four well-known ME/CFS and immunology experts to speak.

Image of the NIH campus.