The Solve ME/CFS Initiative held a phone call with Vicky Whittemore, Ph.D., of the National Institutes of Health yesterday regarding our concerns over staffing of the NIH’s new intramural study on ME/CFS.
Specifically, our organization is concerned about the appointment of Dr. Brian Walitt, who is the Lead Associate Investigator on the study under the leadership of Principal Investigator Dr. Avi Nath. As other advocates have reported, Dr. Walitt has made public comments regarding his belief that ME/CFS and fibromyalgia are psychosomatic. Dr. Whittemore was very receptive to our strong opposition to Dr. Walitt’s participation in the study, but said that she has no role in the study design or staffing; that rests with Dr. Nath.
The Solve ME/CFS Initiative urged proactive patient participation in the study to avoid similar missteps and ultimately prevent bad science and the waste of taxpayer dollars. Dr. Whittemore said that the NIH is now actively exploring ways to integrate patients into the study to the full extent that it is allowable and legal. Whittemore said that they have identified three avenues for patient feedback so far:
1. Include an open period during each Trans-NIH Working Group meeting in which patients can ask questions and offer their feedback;
2. Include advocates on the smaller working groups created in conjunction with the study; and
3. Hold regular teleconferences throughout the study so that community members can receive updates on progress from the investigators themselves. The first conference call is expected to be announced this week.
In other updates, Whittemore said:
- In a follow-up email responding to our question regarding the cost of the intramural study, Whittemore responded: “We don’t yet know what the cost will be because they are still revising the protocol. NIH will spend whatever is necessary for this study to get answers to some basic questions about the clinical and biological characteristics of ME/CFS. Any taxpayer dollars spent on this study will be in addition to use of the unequalled resources and facilities of the NIH Clinical Center.”
- The NIH would be providing updated responses to the Chronic Fatigue Syndrome Advisory Committee recommendations from last fall. At the time NIH responded to the CFSAC recommendations, the Trans-NIH Working Group had not yet been formed, so the NIH’s responses were based on limited information. The updated responses could be available as early as next week.
- The NIH is developing an outline of research strategies and initiatives, which will be reviewed by Dr. Walter Koroshetz, director of the National Institute of Neurological Disorders and Stroke, and the entire Trans-NIH Working Group. Whittemore said the outline will be shared with the ME/CFS community as soon as it’s final. “I think you’re really going to be happy with what we’re planning,” she said.
- The NIH is currently looking for funding for the initiatives in the Fiscal Year 2016 budget since no NIH Institute has set-aside dollars.
- She, Dr. Koroshetz and Dr. Collins remain committed to research regarding ME/CFS.
Solve ME/CFS Initiative President Carol Head will continue to raise the concerns over Dr. Walitt when she meets with NIH officials in D.C. on March 8 along with fellow advocate Mary Dimmock.
NIH February 24, 2016