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.
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:
Is the protocol too broad in its inclusion and as such has little value, or too narrow in that it excludes by design the bulk of relevant patients? Why is it not based on the Canadian Consensus Criteria, which is regarded as the “gold standard” for this complex disease?
Did the protocol examine in-depth the recent advances in the field, including the wealth of information compiled in the 2015 Institute of Medicine report and the slew of commentaries and analysis since, especially on criteria definition beyond the 2003 Reeves criteria? While the study does not rely solely on the Reeves criteria, a clear rationale behind the protocol must be provided. For example, have characteristic ME/CFS symptoms like post-exertional malaise been incorporated under this protocol? If not, why not?
Is this protocol timely and current? In other words, has it benefited from or clearly incorporated the most recent developments in technology, clinical management, basic research or scholarly advances in the field, for instance, the literature and recommendations included in the IOM report?
Has the issue of comorbidity been carefully considered? More specifically, has a clear distinction been made between primary, pathway-specific diagnoses/manifestations versus secondary and pleotropic symptoms like depression or lethargy often associated with a plethora of chronic diseases, such as cancer and diabetes?
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.
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- It is (generally) not fatal (It’s a life sentence, not a death sentence.)
- There is significant stigma so patients don’t self-identify
- Patients are often impoverished by this disease
- It’s difficult to be diagnosed; most are not
- There are still no clear causes on which to build research budgets.