On Oct. 19, 2011 results of a double-blind placebo-controlled phase II clinical trial of rituximab were published in PLoS ONE. The study was small, with just 15 CFS patients in each arm, but it showed promising results. 67 percent of the patients treated with rituximab, a monoclonal antibody, showed improvement after two infusions given two weeks apart, compared to 12 percent of those who received placebo. Rituximab is approved for use in certain cancers and rheumatoid arthritis. It is one of manufacturer Roche/Genentech’s “blockbuster” drugs. The study attracted attention from media around the world and resulted in an apology from Norway’s Directorate of Health for the poor care that patients with CFS have received in the country’s health care system. Two additional open-label phase II studies are now under way and the team at Haukeland Hospital in Bergen (Norway) is working with other centers to design a larger phase III study.
An international panel of 26 researchers, physicians and teaching faculty has published new criteria for myalgic encephalomyelitis (ME) in the Journal of Internal Medicine ahead of print on July 20, 2011. The panel recommends use of the term ME and the new criteria as a replacement for CFS in research and clinical settings. The criteria propose one compulsory feature — post-exertional neuroimmune exhaustion (PENE) — plus seven symptoms from three subdivided symptom clusters: neurological, immunological and energy production/transport impairments, summarized here. There is sure to be more discussion about the change in both the name and criteria for both have potentially far-reaching consequences for research, policy and education. A study published a week later in BMC Medicine used three case definitions to identify ME/CFS cases in three populations of England. Based on their analysis, the authors recommend using both CDC-1994 definition (for CFS) and Canadian definition (for ME/CFS) to strengthen research studies.
The National Institutes of Health (NIH) hosted the ME/CFS State of the Knowledge Workshop on April 7-8, 2011. The workshop brought together subject matter experts to discuss multiple aspects of ME/CFS, including epidemiology, etiology, pathophysiology, diagnosis and treatment. The workshop panelists helped identify gaps in knowledge and opportunities for advancing biomedical research. NIH Director Francis Collins addressed the meeting and several other top Department of Health and Human Services and NIH staff attended all or part of the workshop. Secretary Kathleen Sebelius expressed her support in a letter sent to workshop participants. Read a summary of presentations. The NIH has also produced a report on the meeting.
The Department of Health and Human Services (DHHS) CFS Advisory Committee (CFSAC) meets twice a year to make recommendations about research policy to the Secretary of Health and Human Services. At its meeting on Oct. 12-14, 2010, the first day was dedicated to a review of key scientific findings. The committee met most recently on May 10-11, 2011 and Nov. 8-9, 2011. Agendas for, minutes of and presentations from past meetings are archived on the DHHS site. DHHS recently solicited nominations for terms of three members that end in early 2012. The Solve ME/CFS Initiative nominated four individuals to serve.Tags: ME study, Rituximab October 19, 2011