1) If this call is patient-centered, why is all the information flowing from you to us, i.e. why are we asking the questions and you are giving the answers? The patient community has demonstrated repeatedly that information disseminated by the CDC about ME/CFS is inaccurate. Because so little information is available to our doctors, we have been forced to become very informed patients. Shouldn't you be listening to us?
2) What did you learn from the last set of calls and what changes have you implemented as a result of them?
3) Given the importance of a rapid response in epidemiological investigations, have you developed a protocol for identifying and investigating geographic or family clusters of ME/CFS as soon as they are reported to you?
4) Have you initiated any studies of current geographic or family clusters?
5) Have you taken any steps to make ME/CFS a reportable disease so that clusters will be identified?
6) Are there any longitudinal studies of appropriately-defined ME/CFS (not Consensus definition-defined) in progress?
7) Is the CDC making any efforts to identify the sickest, house-bound patients?
8) The CFSAC recommended that the Toolkit be removed from the CDC's website and that it should no longer be distributed at its June, 2012 meeting. Why hasn't this been done? Why is there no mention of the IACFS/ME Primer as an alternate source of information? Why is the link to the Toolkit still active on the CFSAC website?
9) The only definition that is immediately obvious on the CDC website is Fukuda, and this is the only definition mentioned in the CDC's CME activity. Why is there no mention of other definitions more acceptable to the patient community and of the controversy that surrounds the definition?
10) When and how do you plan to attempt to resolve the definition issue? Does CDC think that it alone should determine the definition? Do you plan to resolve it based on a single study of six (or seven?) practices? Have you built into the design of that study a method to ensure that the practices are consistent with each other? If one or more of the practices has looser standards and include(s) patients who only meet the definition for Idiopathic Chronic Fatigue will that practice or practices be separated out as (an) outlier(s)? When will that study be published? Are you aware of the recent Maes, Twisk and Johnson study (Psychiatry Research, in press, available online) that shows that ME, CFS and CF can be distinguished accurately using post-exertional malaise and inflammatory biomarkers? Before you try to develop a better definition do you plan to ask for the input of other stakeholders, including patients, who may have additional information to offer? Will the IACFS/ME be an equal partner? Will other specialty organizations be involved?
11) Has the previously-announced five-year strategic plan been shelved? Has it been replaced by another plan? If so, where can we find it?
12) What ME/CFS research projects are currently underway at CDC? What definition do they use to identify patients?
13) What is the next study that we can expect to see CDC publish? Is it designed to imply that ME/CFS is a psychological disorder?
14) What is the total annual budget for ME/CFS at CDC for the last ten years, and what is the current annual budget as well as the budget for the next two years? Is, as recently reported, the budget actually decreasing?
15) The CDC CME program states "Importantly, no scientific evidence exists to indicate that CFS is contagious or that it can be transmitted from person to person." Would it not be more accurate to state "Given the existence of family and geographic clusters, there is certainly reason to suspect that an infectious agent is involved. However, no single agent has yet been proved to cause the disease. Given the high incidence of viral and other co-infections, such as EBV and HHV-6 among others, it is reasonable to test for these pathogens and consider treatment, if present. Individual clinicians have reported treatment successes with this strategy. Further research is necessary."?
16) At the CFSAC meeting in June, 2012, Dr. Peter Rowe reported that over 80% of his patients have orthostatic intolerance. At what level of prevalence of this potentially treatable symptom will the CDC decide to recommend that all patients be tested and treated for OI? Do 100% of patients have to have the symptom before CDC recommends testing and treatment?
17) At the CFSAC meeting in June, 2012, Dr. Peter Rowe reported that over 80% of his patients have post-exertional malaise. There are now two measures of post-exertional malaise in the literature: Pacific Fatigue Laboratory testing and gene expression testing. At what point will the CDC include these tests in its recommendations for lab tests on its website?
18) What constitutes a biomarker? Why don't tests for orthostatic intolerance and post-exertional malaise qualify as biomarkers for ME?
19) At the June, 2012, meeting Dr. Koh stated that the CDC has "made available clinical assessment data" in its "research data center". How can this data be accessed?
20) The CDC CME program repeatedly refers to areas where increased research needs to be done. What are you doing to make sure that adequate funding is available to make sure this research done? Presumably, you are participating in the HHS cross-department ad hoc work group for ME/CFS. If you aren't, who is the representative from the CDC on this panel? What have these meetings accomplished to date? Are you personally emphasizing that there are many areas where increased research is vital to improve our understanding and care for ME/CFS patients and funding for these projects must be increased? Is there any move in these meetings toward a strategic plan for research? Have there been more than two meetings?
21) Obviously, there are too many questions here to answer in an hour. When can we expect to have a longer, more substantive meeting with the CDC to have a bidirectional discussion of the many issues and develop a strategic plan to address them effectively?
For Dr. Jason:
1) Can you describe the difference between a clinical and research definition?
2) You are a researcher. Do you think your opinions of a clinical definition are more valid than a clinician's?
3) You have done a large amount of very important research about the definitions of ME, CFS and ME/CFS. Given that no definition is perfect and that you have demonstrated in your research that definitional disputes have had a significant negative impact on progress in researching ME, CFS and ME/CFS, do you think it is useful to propose another definition of ME at this time? Do you think it is necessary to have a perfect definition or is an adequate defintion adequate?
4) There is a new study by Maes, Twisk and Johnson (Psychiatry Research, in press, available online) that shows that ME, CFS and CF can be distinguished accurately using post-exertional malaise and inflammatory biomarkers? How does this article affect your opinion about how to proceed to resolve the controversy over the definition?
Joan Grobstein, M.D.