Also, I'm feeling a little defensive because Hillary Johnson has decided to attack me on twitter (without engaging with me), and someone called me an NIH shill. Well, I wonder if a gobsmacked shill would have sent this to the NIH director. (This is most of my letter to him from Feb. 8):
Dear. Dr. Collins,
It has taken me longer than I had planned to get back to you, but I do appreciate the call from you last fall. Thank you for taking an interest in our illness and pushing for positive change at NIH.
However, I am growing concerned that the good will among patients generated by your announcement is slipping away. The NIH's responses to the latest recommendations from the CFS Advisory Committee disappointed many patients, including myself. Nearly every response was dismissive of CFSAC's earnestly thought-out recommendations. These responses have patients worried that positive change is not happening quickly enough.
Here are some ideas about how NIH can continue to build a bridge to the patient community.
- Patient involvement in NIH's research plans is vital. Appointing a patient representative - and possibly an organizational representative as well - to the Trans-NIH Working Group on ME/CFS would be a hugely positive step. [xxx and xxx] would make excellent patient advocates. They are both reasonable, forward-looking people with deep knowledge of ME/CFS research. Zaher Nahle of the Solve ME/CFS Initiative would be a good choice for an organizational representative. The ad hoc meetings Drs. Koroshetz and Whittemore have hosted recently are important, but I think it's much more important to formalize patient and advocate involvement.
- The NIH researchers involved in the new ME/CFS research effort could host an online Town Hall for patients, advocates, clinicians, and researchers. Such an event would show openness and a willingness to consider patient input.
- Patients are waiting to hear about dedicated funding for extramural researchers. The growing cohort of ME/CFS researchers in the US working on biomarkers, cellular and molecular pathology, and potential treatments desperately needs funding. An RFA or some other mechanism dedicating a pot of money would be a very positive step. The NIH response to the CFSAC recommendation of an RFA repeated an unfortunate line that I thought had been debunked: That there are few to zero "good quality" ME/CFS funding applications. With Congress boosting the NIH budget, and with the 10% HIV/AIDS set-aside expiring, now is the perfect time for a dedicated external ME/CFS budget.
- NIH could consider funding ME/CFS Centers of Excellence to bring together clinicians and researchers. There are enough experts in the US for two or three such centers, which have been instrumental in pushing ahead new treatments for other disorders.
- NIH researchers working on ME/CFS could invite outside experts in for a seminar series. I'm sure many of the researchers I've gotten to know would love to share their work with NIH colleagues. Such a seminar series would cost very little but could build a lot of goodwill. I could suggest a list of researchers to invite.
- The clinical protocol posted recently suggests the NIH will be using the outdated Reeves criteria to select patients. These criteria do not include the hallmark symptom of ME/CFS identified by the IOM - post-exertional malaise. Using Reeves criteria will draw in a heterogeneous group of patients, including some who have chronic fatigue - the symptom - but do not have post-exertional malaise and do not have ME. Patients are dismayed that the IOM's work in this area has been ignored. The P2P group by NIH convened also made this important distinction and suggested research criteria must include post-exertional malaise. The NIH team has missed an opportunity here to proactively communicate how and why they are designing the study this way. Channels of communication need to be more open.
Thanks for reading this note. I am happy to discuss any of this with you.
BV
