Research Recommendations

See Part One – Tangled Web
See Part Two – CFSAC Specific Recommendations
See Part Three – Care and Services Recommendations
See Part Four – Education and Training Recommendations

Appropriately enough, the CSFAC has made more recommendations on research than any other topic. See pages 1 – 7 of the Recommendations Chart (pdf link). It’s too cumbersome to review them one by one, but we can start by setting aside many as complete or obsolete and then cover the rest by category.

Finished or Obsolete

The greatest number of completed recommendations relate to CDC. Through 2009, the CSFAC made twenty-one recommendations related to CDC research, leadership and funding. Eighteen of those are marked as complete. I think this designation is accurate for several reasons, and in fact, I consider all twenty-one to be complete or obsolete. For example, I think recommendations related to the restructuring of the CDC program in November 2007 should be discarded as either extremely unlikely (e.g. place an extramural effort in the Office of the Director) or irrelevant (e.g. recommendations from the Blue Ribbon Panel). All of the recommendations related to the composition and focus of the Blue Ribbon Panel from May and October 2008 are also obsolete, as that Panel met in late 2008. Finally, all the recommendations regarding the CDC’s five year plan are obsolete as that plan has been mothballed ahead of schedule (although I would love to hear the early death of that plan explored at a CFSAC meeting).

Oddly, one of these completed recommendations was included in the CFSAC’s High Priority list. One of the five-year plan recommendations included a subpart saying that “Identification of biomarkers and etiology of CFS” should be a priority area (May 2009). I’ve previously explained how that subpart was combined with other recommendations to create a new recommendation never voted on by the Committee.

There are several other recommendations that I think should be discarded as obsolete. The recommendation for a intramural staffed laboratory (September 2004, repeated August 2005) and the recommendation for CDC and NIH to sponsor focused workshops (September 2004, repeated August 2005, marked complete by CFSAC) have been partially acted upon, and the language probably needs clarification to reflect that. Both the recommendation to include CFS in the NIH Roadmap Initiative (November 2006) and endorsement of the NIH State of the Knowledge meeting (October 2008) are accurately marked complete. Another recommendation is omitted from the Recommendations Chart, but might be considered complete in any case. The September 2004 recommendation urges the use of a Request for Applications with set aside funds. NIH did in fact issue an RFA for CFS in 2005, so it’s fair to mark this one complete.

Two recommendations marked complete on the Recommendations Chart are not complete, in my opinion, and I cover those below. In addition, one recommendation was omitted from the Chart, and one was miscategorized as Research and I covered it in the Education section. By my count, that leaves fifteen recommendations for review. These break down into recommendations on Centers of Excellence, NIH funding, and specific kinds of research.

Centers of Excellence

The CFSAC has long supported the idea of regional centers for CFS that would offer the best care, as well as opportunities for research and education. The specifics have changed over the years as the Committee has repeated and refined the idea, but they have recommended such Centers six different times. Three of them have no progress reported:

Direct the NIH to establish five Centers of Excellence within the United States that would effectively utilize state of the art knowledge concerning the diagnosis, clinical management, treatment, and clinical research of persons with CFS with funding in the range of $1.5 million per year for five years. (9/04; 8/05)

Establish Regional Centers funded by DHHS for clinical care, research, and education on CFS to provide care to this critically underserved population, educate providers, outreach to the community, and provide effective basic science, translational, and clinical research on CFS. (5/09)

Establish Regional Centers funded by DHHS for clinical care, research, and education on CFS. (10/09)

Two recommendations are presented on the Chart in abbreviated form. The May 2007 recommendation includes five paragraphs of text laying out the dire need for research and clinical care and how regional centers could begin to meet that need. The Chart includes only the bolded text from that page:

HHS establish 5 regional clinical care, research, and education centers, centers which will provide care to this critically underserved population, educate providers, outreach to the community, and provide effective basic science, translational, and clinical research on CFS. (5/07)

The October 2010 recommendation is an odder situation. Both the Chart and the CFSAC webpage for the recommendation list only two sentences:

Develop a national research and clinical network for ME/CFS (myalgic encephalomyelitis/CFS) using regional hubs to link multidisciplinary resources in expert patient care, disability assessment, educational initiatives, research and clinical trials. The network would be a resource for experts for health care policy related to ME/CFS. (10/10)

However, the minutes of the meeting indicate that the recommendation continued for several paragraphs more. The text makes the argument for why centers would address physician education, clinical care and translational research, and further recommends a national network of large databases to support sub-typing and focused treatments. (CFSAC Minutes, October 14, 2010, pp. 53-56)

The most recent recommendation in this category is from November 2011:

CFSAC would like to encourage and support the creation of the DHHS Interagency Working Group on Chronic Fatigue Syndrome and ask this group to work together to pool resources that would put into place the “Centers of Excellence” concept that has been recommended repeatedly by this advisory committee. Specifically, CFSAC encourages utilizing HHS agency programs and demonstration projects, available through the various agencies, to develop and coordinate an effort supporting innovative platforms that facilitate evaluation and treatment, research, and public and provider education. These could take the form of appropriately staffed physical locations, or be virtual networks comprising groups of qualified individuals who interact through a variety of electronic media. Outreach and availability to underserved populations, including people who do not have access to expert care, should be a priority in this effort. (11/11)

This recommendation was included in the High Priority list. It was also addressed in Assistant Secretary Dr. Howard Koh’s response to the Committee on August 3, 2012 (pdf link). Dr. Koh said that the Ad Hoc Workgroup was developing a Department-wide plan and opportunities for interagency collaboration. CFSAC recommendations would be considered by the Workgroup, and the finished plan would be posted on the CFSAC website. But readers of this blog will remember that in reality, we will not be getting a plan and the chances of funding regional centers seem very slim indeed.

 NIH Funding

If CDC-related recommendations have been accurately marked complete, the same is not true of the NIH-related recommendations. NIH is the largest source of biomedical research funding in the Unites States, and it is appropriate for it to be the focus of the CFSAC.

Only one recommendation is not expressly about the amount of funding available from NIH. At the October 2012 meeting, the Committee recommended “establishing a dedicated standing committee for ME/CFS at NIH.” The Recommendations Chart contains a note referring to the Trans-NIH ME/CFS Research Working Group, although the document referenced is not responsive to this recommendation. But the minutes of the meeting make clear that what was contemplated by the CFSAC was not a standing committee like the Trans-NIH group already in existence, but a standing study section responsible for reviewing ME/CFS related grant proposals (CFSAC Minutes, October 3, 2012, p. 44).

The same cannot be said for the other CFSAC recommendations on NIH funding:

Based on the positive response to the NIH’s Request for Applications issued in July 2005 (funded in 2006), the Committee recommends equivalent funding for a second RFA. (11/06)

CFSAC recommends to the Secretary that the NIH or other appropriate agency issue a Request for Applications (RFA) for clinical trials research on chronic fatigue syndrome/myalgic encephalomyelitis. (11/11)

Both of these recommendations are marked as complete on the Chart. The notes refer to NIH Program Announcements which do not have dedicated funds set aside. As I have said to the CFSAC in the past, a recommendation for an RFA with set aside funds cannot be considered completed through program announcements with no dedicated funding.

The last two recommendations have no progress noted on the Chart.

ME/CFS is an illness with enormous economic and human costs. The April 2011 NIH State of Knowledge Workshop identified a number of gaps in what is known about the illness. To address these gaps warrants an interagency effort comprising, but not limited to, NIH,CDC, and AHRQ. Further, the focus should be on interdisciplinary discovery and translational research involving interacting networks of clinical and basic science researchers. Areas to be examined would include the following: identification of patient subsets for detailed phenotyping and targeted therapeutic interventions, biomarker discovery, systems biology approaches and disability assessment.(5/11)

CFSAC recommends that you instruct the NIH to issue an RFA (funded at the $7-10 million range) for projects to establish outcomes measures for ME/CFS diagnosis, prognosis and treatment which would include but not be limited to biomarker discovery and validation in patients with ME/CFS. (10/12)

The May 2011 recommendation is notable for its inclusion on the High Priority list. However, as I’ve previously noted, the recommendation was substantially altered both on the Chart and on the list. Specifically, both documents delete the following text:

To facilitate the above goal, CFSAC recommends that ME/CFS research receive funding commensurate with the magnitude of the problem and that the NIH (and/or other appropriate agencies) issue an RFA specifically for ME/CFS.

If this recommendation is to be designated as a high priority, the full text must be included. That deleted sentence sets the spending level (commensurate with the problem) and the method (an RFA). These are essential elements of the recommendation.

Specific Types

Finally, CFSAC has made recommendations that focus on particular topics or kinds of research. I’ve listed each in its entirety below along with any relevant notes from the Chart.

DHHS should provide funds to develop an international Network of Collaborators that would allow for multidisciplinary CFS-related research using standardized criteria accepted by the international CFS research community. (9/04, 8/05)

The full recommendation continues, “Such a network would pool large number of patients from around the world, and would require investigators to develop and employ common protocols.” This is different from the Centers of Excellence recommendations because it specifically contemplates international collaborations and standardized criteria and common protocols.

Promote, encourage, and fund research directed toward the diagnosis, epidemiology, and treatment of CFS in children and adolescents. (9/04; 8/05)

This recommendation is marked completed and the Chart refers to several program announcements in the notes. However, this focus area is one of ongoing concern and it does not seem fair to consider it finished.

Finally, two recommendations from October 2012 focus on specific patient populations. The Chart assigns the agency responsibility to CDC, but it seems to me these are relevant to NIH as well:

CFSAC recommends that you allocate specific funds to study patients with ME/CFS from past cluster outbreaks. (10/12)

CFSAC recommends that you allocate funds to study the epidemiology of patients with severe ME/CFS. (10/12)

 Keep in Mind

Of the fifteen recommendations, six relate to the Centers of Excellence concept. Four recommendations relate to NIH RFAs, and one was intended to create a permanent committee (or study section) and NIH. The last four recommendations relate to international collaboration, pediatrics, cluster outbreaks, and severely ill patients. More than any other category, the recommendations on research have been condensed in the Chart and much of the excluded language is important. This has to be considered when selecting recommendations for the final designation as high priority.

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1 Response to Research Recommendations

  1. Kati D says:

    Thank you so much for such detailed info Jennie.

    i find the whole process of gvoernment policies and non-action so frustrating- the stigma and neglectis still in 2013 happening and scientists and our expert physicians left dry without crucial funding while other diseases get more than plenty of money and research.

    In my opinion the NIH needs to increase participation and efforts. It was really sad loosing Dr Mangan who seemed to have the desire to increase transparency.

    I think that the reluctance from the us agencies notably the NIH and CDC but also HHS to fund us and to research us echoes far and wide around the world. but thenthe UK psych lobby is being successful in spreading their BS all over.

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