Over the weekend we wrote to NIH to share our article about Brian Walitt, along with comments from the community. We have received an initial response, but expect there will be more responses forthcoming that directly address patients’ concerns. The NIH also said they are finalizing a communications plan on the study so that communications will be less ad-hoc and more transparent to the entire community, and are organizing a phone call to answer questions about the study. In the meantime, we are working on finalizing a petition which we will share as soon as it is completed. All members of the community are also welcome to submit their own petitions on any topic at http://my.meaction.net/petition/new?source=header.
NIH’s initial response:
Dear Jen and Beth,
Thank you for sharing your thoughts and concerns. Dr. Koroshetz, as Chair of the Trans-NIH ME/CFS Working Group, and I are excited about the study on ME/CFS that will begin soon at the NIH Clinical Center. It is the first step of what the NIH hopes will be a broader national approach to better understand the biological basis of ME/CFS and the development of effective therapies.
In terms of trial leadership, Dr. Nath will serve as the Principal Investigator in charge of study design, as well as its execution, analysis and interpretation of the data. As the Lead Associate Investigator, Brain Walitt will assist Dr. Nath with the oversight of the day-to-day clinical operations of the protocol. Dr. Walitt will work with the CDC and the NIH ME/CFS executive committee to coordinate screening of potential participants for the study. He will ensure that participants are provided with clear details of the research study prior to enrollment as part of the NIH informed consent process and will coordinate participants’ care with the local medical providers. He will also help integrate the work of the team of experts who are collaborating in this complex undertaking and will provide clinical oversight for the study participants during their time at the NIH Clinical Center.
The NIH has unique resources to bring to bear on ME/CFS, especially with respect to neurology, immunology, radiology, nursing and rehabilitation science. We also have a dedicated, multidisciplinary team that is eager to address this challenge. We have utmost confidence in the team, which combines the expertise of multiple NIH Institutes including NINDS, the National Institute of Allergy and Infectious Diseases, National Institute of Nursing Research and National Heart, Lung, and Blood Institute. We sincerely believe that the combined resources and expertise of the NIH will shed light on a previously unsolved medical puzzle. With your help, we are ready to get started on the path that we hope will lead to improved diagnosis, effective treatments, and, ultimately, a cure for ME/CFS.