Rainbow at shoreline

The Massachusetts ME/CFS & FM Association, a 501(c)3 founded in 1985, exists to meet the needs of patients with ME (Myalgic Encephalomyelitis), CFS (Chronic Fatigue Syndrome) or FM (Fibromyalgia), their families and loved ones. The Massachusetts ME/CFS & FM Association works to educate health-care providers and the general public regarding these severely-disabling physical illnesses. We also support patients and their families and advocate for more effective treatment and research.

Does Advocacy Work, P2P Edition - Good News and Bad News

by Charmian Proskauer
President, Massachusetts CFIDS/ME & FM Association
April 8, 2015

What's the scorecard on advocacy with federal agencies? Does it work? At this point, the review has to be mixed.

Let's take NIH's on-going Pathways to Prevention program for ME/CFS, run from the Office of Disease Prevention (ODP) as an example.

The Program, Advancing the Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, was announced near the end of 2013. A Working Group was formed to consider what questions the study should consider, and met in early January, 2014. The Working Group included several prominent ME/CFS clinicians and researchers, as well as a patient representative. This group also planned the agenda and created nominated speakers for the Workshop. GOOD NEWS

In August 2014, after the Workshop Agenda was published, our Association along with 6 others sent a letter requesting a change to the Agenda to include a fuller discussion of case definitions. The final Workshop Agenda limited the case definition discussion to a single 20-minute presentation by Dr. Lenny Jason. GOOD NEWS to have this presentation by an acknowledged expert in case definition; BAD NEWS that it was still only 20 minutes.

An outside agency, Pacific Northwest Evidence-based Practice Center, under contract to the Agency for Healthcare Research and Quality (AHRQ), prepared an Evidence Report. This was first published in draft form with a 4-week period for public comments. Many advocates submitted comments. In addition, the report was reviewed by a panel of experts. GOOD NEWS

The final Evidence Report (also referred to as the "AHRQ report") was made public on December 9, 2014, the same day the Workshop took place. While the final Evidence Report mentioned the many comments submitted, it did not discount findings form the controversial PACE study, which many advocates had requested. The workshop attendees, and the Panel, would not have had time to review the final report prior to their in-person public meeting. BAD NEWS

The final Evidence Report states on p. 11 of the PDF: "The draft report was further edited in response to these [expert] reviews and [public] comments, and the specific responses were outlined in a table that will be made available after AHRQ posts the final systematic review on the public Web site." To date, this table has not been posted. BAD NEWS

The Workshop was held on Dec. 9-10, 2014. The study panel (5 non-experts) was announced just before the workshop took place. It was a public meeting, and was also videocast live. The videocast and other resources were archived and are available to the public. GOOD NEWS

The draft report was published approximately one week later. While the report contained many good points, and for the most part accurately relayed what the experts presented during the workshop, there were a number of major errors. Furthermore, the treatment recommendations, based heavily on the AHRQ Evidence Report, which explicitly outlined the limitations of the evidence and recommended that future studies not include patients selected with the Oxford case definition (which was used in the PACE trial), pointed prominently to Graded Exercise Therapy (based on the PACE trial), as well as Cognitive Behavioural Therapy and other "biopsychosocial"approaches as primary treatments. BAD NEWS

The original public comment period on the draft Workshop report was scheduled for 2 weeks from date of publication, which would have been from around Dec. 17 to Jan 1st. At the request of a number of advocates including our August letter (and perhaps an exercise of common sense) the comment period was extended to January 16, 2015. GOOD NEWS

In response to queries from advocates, ODP at first said it would not retain public comments, but simply pass them over the the panel. BAD NEWS

This stance was later changed.  Advocate Jennie Spotila offered to post a copy of all public comments on her blog, if advocates sent them to her for posting. The P2P library eventually contained well over 70 entries from individuals and patient organizations, many of them lengthy and well-referenced. The themes expressed in these comments were very consistent. A strong and uniform message emerged from our community. GOOD NEWS

The publication of the Final report (from the study panel) was announced for April 14, 2015. Prior to that, advocate Jennie Spotila filed a Freedom of Information Act (FOIA) request, asking to see all comments form the public which were filed by the deadline of January 16. When the 308 p. PDF was provided, Jennie noticed that comments from several sources were not in it, including those from our own Association and those from the Chronic Fatigue Syndrome Advisory Committee. BAD NEWS!

Jennie filed a follow up FOIA request requesting the missing comments. Shortly after that, this notice was posted on the P2P ME/CFS web page:

"The ODP recently discovered that one set of public comments was not forwarded to the panel for consideration. Because the ODP is committed to ensuring that all public comments have been considered, we have paused the publication process in order to give the panel time to consider the new information and determine if changes are needed before the release of the final report. Once the panel has been able to deliberate, the publication process will resume, and the ODP will announce a new timeline on our website."

Jennie has written about this "P2P Mistrial" in her blog.

Our Board sent a letter to the Office of Disease Prevention, expressing our outrage that the panel was not given the opportunity to fully consider ALL comments submitted by the public, and strongly urging that the panel be reconvened in person to do so. You can read our letter here. We have also urged others to write to ODP. It is not clear at this point how many comments were not passed on; "one set" includes at least 3 submissions that we know about, but there could be many more. To date there has been no response from ODP. We will provide an update when we have further news to report.

So, Does Advocacy Work?  It can help to keep our public agencies honest - that's the GOOD NEWS. The BAD NEWS is that this kind of work is tedious and time/energy consuming, which seems a terrible burden to place on our community.

Response from Office of Disease Prevention April 14 2015

This is the text of the letter we received from the Office of Disease Prevention on April 14th, in response to our letter of April 3rd.

 
Dear Ms. Proskauer:
 
Thank you for your message and interest in the NIH Pathways to Prevention workshop: Advancing the Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.
 
In response to your comments and questions:
 
The recently released report from the Institute of Medicine should also be reviewed and considered by the panel. 
It is beyond the scope and charge for this panel to consider and incorporate the Institute of Medicine (IOM)’s recommendations within their report because the IOM report was released after the P2P workshop.  The panel can only consider materials available at the time of their workshop.
 
1.  How will the missing comments be retrieved? Can they even be found? (I would be happy to re-submit our comments if you cannot find them.) How many comments were not passed on, and from whom were they? (Would obtaining this information require another FOIA request?)
There were 46 comments that were inadvertently misplaced and not sent to the panel originally. All comments received by the NIH Office of Disease Prevention (ODP) are now on file and we have confirmed that all comments have been forwarded to the panel for consideration. The ODP cannot release the contact information for the individuals and organizations who submitted the comments because we did not obtain their permission to do so. The ODP is committed to ensuring that all public comments have been considered by the panel before completion of their final report. That is why we paused the publication process in order to give the panel as much time as it needs to thoroughly review and consider all submitted comments before the release of the final report. Once the panel has finished its deliberations, the publication process will resume, and the ODP will announce a new publication schedule on our website.
 
2.   Exactly what process will be used by the panel to reconsider their revision in light of these comments?
The panel chose to review the additional comments via a teleconference that they arranged.
 
3.  What actions will be taken to prevent any future occurrences of an error like this? How can the public be assured that their input will be received and carefully considered? 
For future P2P workshops, public comments will be posted online as they are submitted to enhance the transparency of this process and to ensure that all comments are received by the panel in a timely manner.
 
 
Sincerely,
Jody Engel
 
Jody Engel, M.A., R.D.
Director of Communications
NIH Office of Disease Prevention

What is your response to the IOM Report? What were your earliest symptoms of ME/CFS?

"What is your response to the IOM Report?" (Survey conducted by Massachusetts CFIDS/ME & FM Association between Feb 32 and March 20, 2015)

"What were your earliest symptoms of ME/CFS?" (Survey conducted by Massachusetts CFIDS/ME & FM Association March 30 – April 18, 2015)

The results of these two surveys are now available.

IOM Report Survey. The 86 responses to the IOM Report survey represented a range of opinion from highly positive to dismissive, and most were thoughtful and showed a good understanding of the contents of the report. All of the responses were provided to the CFSAC IOM/P2P Working Group members (as indicated would be done in the Introduction to the survey), and a sampling/summary of responses is published here.

Early Onset Symptoms Survey. This survey received 800 responses and included many comments.The survey is not scientific, but the large number of responses makes it significant.The results suggest that the symptoms in the first few months of the illness (or what later turns into ME/CFS) are quite heterogeneous, with fatigue and cognitive impairment occurring most frequently. Clearly this is an area that deserves further study. If the disease (or the triggering events, such as infectious mononucleosis or a severe flu-like illness) is recognized early and proper treatment/management is provided (e.g. rest as needed), perhaps fewer people would develop the severe, chronic form which we identify as “ME/CFS.” Results are summarized here.

Notice about names

The Massachusetts ME/CFS & FM Association would like to clarify the use of the various acronyms for Chronic Fatigue Syndrome (CFS), Chronic Fatigue & Immune Dysfunction Syndrome (CFIDS) and  Myalgic Encephalomyelitis (ME) on this site. When we generate our own articles on the illness, we will refer to it as ME/CFS, the term now generally used in the United States. When we are reporting on someone else’s report, we will use the term they use. The National Institutes of Health (NIH) and other federal agencies, including the CDC, are currently using ME/CFS. 

Massachusetts ME/CFS & FM Association changed its name in July, 2018, to reflect this consensus.