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Solve ME/CFS Initiative Registers Major Concerns over NIH Study

Editor's note: After the NIH posted its protocol for its in-house study on ME/CFS, there was a firestorm of protest, which took Dr. Walter Koroshetz, the man in charge of the new NIH ME/CFS research program, by surprise. The protest centered on the fact that the criteria used to identify patients, the Reeves criteria, also known as the Empirical Definition, had never been used in research, largely because of its inadequacies. (There were a number of other  problems with the protocol, which you will find references to in the Solve ME/CFS Initiative questions.) NIH removed the protocol, and then Dr. Koroshetz did something without precedent. He called Carol Head, the CEO of Solve ME/CFS Initiative. Below you will find the questions raised by Solve ME/CFS Initiative after the protocol was posted, as well as Carol Head's summary of her conversation with Dr. Koroshetz. 

Reprinted with the kind permission of Solve ME/CFS Initiative [1].
The National Institutes of Health is beginning to recruit participants for its in-house study of ME/CFS patients. The Solve ME/CFS Initiative has identified a number of significant questions and concerns with the design protocol of this research effort. Our organization—represented by our Vice President for Research and Scientific Programs—was immediately in contact with the NIH officials we have an existing, ongoing relationship with to express these serious concerns. We will push forward to determine what may be done to address them and ensure that this study is leveraged to the full benefit of ME/CFS patients. The Solve ME/CFS Initiative also will work in concert with other advocates to ensure maximum impact as a community.

Questions regarding the NIH study protocol that the Solve ME/CFS Initiative will be seeking answers to in the days and weeks to come include:

Are the study endpoints themselves–both qualitative and quantitative–well defined, established and objective? Additionally, have the number of patient participants been determined according to a bio-statistical analysis for each endpoint? Is the control group the one most relevant to assess the changes in each endpoint or between groups? Are there follow-up plans/alternatives built into the protocol, given its focus on the aspect of immunity and inflammation as an initial stage?

This is the response NIH made to those questions

From Carol Head

Walter Koroshetz called me moments ago; Zaher Nahle and I had a 20 minute conversation with him and I want to share it.

What was most pointed was his statement that, the NIH often posts protocol-related information online. Most attract zero comment; he is not aware of any posting ever that has attracted the kind of burst of response, all of it negative, that this posting elicited.  They were shocked. 
While we and others have been telling NIH staff about the intense interest in the ME/CFS community, now it has been clearly illustrated.   This gave us the opportunity to explain why: among other things, the intense interest reflects the desperate desire of patients for research progress in this disease. He experienced our decades-long pent-up demand, anger and frustration for federal attention.  We also noted that, while virtually all the feedback to NIH was negative, it was HIGHLY informed.  We are a patient community that highly attuned to the science and the enormous differences among the several historical diagnostic/clinical criteria.
I told him that some in the patient community plan to boycott the study; we has genuinely mystified.  “Why do patients not want ME/CFS research to be done?”  We noted that bad research is worse than no research, and “garbage in / garbage out” will occur if the criteria for defining “ME/CFS patients” is not meticulous and highly attuned.
We also stated that funds for this disease MUST come from the federal government; he cited other diseases in which patients have initiated research by amassing significant funds (e.g. he mentioned Huntington’s disease).  We discussed the differences in our disease, among them:
This makes it quite different from Huntington’s and most other diseases.    My sense was that he may not have considered the disease from this “marketing challenge” perspective before, and therefore understand our unique difficulties in raising private research funds; we are so much more dependent on our federal government than most.  
He now recognizes that the posting was a significant faux pas; they will post a new protocol. He did not say when.
Dr. Koroshetz has demonstrated his goodwill and genuine desire to move forward in a positive way by proactively calling. He did not have to do so and most probably would not. 
Overall, I summarize this as an individual who is committed to doing the right thing and who was shocked by the response.  It was/is a wakeup call regarding the intensity of interest and anger in our patient community, and that’s good.  We cannot and do not speak for everyone in our patient community (No one can…) and at the same time, I believe that we were able to make incremental progress in closing the enormous gap of understanding that exists between patients and the NIH. I am glad that I was able to contain my longstanding, burning anger long enough to have an intense and candid discussion.
Onward, Carol
Carol Head
President, Solve ME/CFS Initiative