I feel like a broken record, saying that the June 16-17th CFS Advisory Committee meeting was frustrating. This meeting struck me as a tangle of threads that can only be understood by teasing them apart. There were signals buried in the discussion that should raise concern in the advocacy community. Rather than summarize the content of the entire meeting, I would like to parse some of the issues with you.
Watching group wordsmithing is always incredibly painful. I know many patients got frustrated during the Committee’s discussions of their recommendations. Despite the fact that Dr. Dane Cook’s group presented a comprehensive summary of the Researcher Recruitment Working Group rationale and well-drafted recommendations, the conversation still went off the rails a few times. Rather than recap the whole thing, I’ll just focus on the recommendations themselves.
The first recommendation was for NIH to fund and support a data platform for biobank and clinical data. The idea is based on the NDAR platform, and Dan Hall gave a great presentation on NDAR but not until after the CFSAC had already passed the recommendation. As a result of this backwards agenda, the CFSAC failed to discuss or include a very important element: funding.
Dan Hall estimated that cloning NDAR for ME/CFS would cost about $1 million, and then somewhat less to maintain annually thereafter. The CFSAC recommendation does not include the price tag for the data platform, and no one discussed the feasibility of requesting this kind of funding. Remember that $1 million is 20% of NIH’s annual spending on ME/CFS research. How likely is it that NIH will spend this kind of money on a data platform for us? I strongly support the recommendation, as a data platform like this is desperately needed and none of the non-profits have the resources to make it a reality. But even with the background support document drafted by Dr. Cook’s Working Group, it seems optimistic to believe that NIH will approve this in the short term.
The second recommendation for an RFA was very controversial, and discussed on both days. The original proposal was that the Trans-NIH ME/CFS Working Group, led by Dr. Mariela Shirley, would recommend the content of an RFA based on the P2P Workshop and the 2011 State of the Knowledge meeting. CFSAC member were appropriately concerned about voting for an RFA based on a document that won’t be written for many months. There was extensive argument, but a motion to remove the reference to P2P failed. Chris Williams (Solve ME/CFS Initiative) pointed out that the recommendation would be “toothless” without a dollar figure, but that was ignored.
There was also great controversy over whether to include a deadline for the RFA. A minority of the CFSAC members felt that including a date would kill the entire recommendation. One suggested deadline was December 31, 2015, but Dr. Alisa Koch (new CFSAC member) pointed out that this would mean grants would not even be reviewed until 2016, let alone funded. Eventually, the CFSAC amended the recommendation to state a deadline of “November 1, 2014, or as soon as feasible.” I agree wholeheartedly with the CFSAC members who pointed out that the “as soon as feasible” would be used by NIH to delay the RFA until whenever it sees fit.
Finally, the CFSAC voted to establish two new working groups. The first, suggested by Dr. Jose Montoya (new CFSAC member) will develop a case for Centers of Excellence. This is a long standing and much repeated recommendation of CFSAC, and developing the case for it will be fantastic.
The second working group, suggested by Dr. Gary Kaplan, will examine ways to interface with Patients Like Me and push that out to the community. I was really surprised by this. While the presentation by Patients Like Me was impressive, Ben Heywood admitted that PLM has not invested any effort in building out the ME/CFS community there. There are multiple problems with the way ME/CFS is defined and measured on PLM. And not a single person raised the issue that PLM is a for-profit company. They aggregate and sell their data. I don’t see how the federal government (directly or through CFSAC) can undertake a project that will specifically benefit a single for-profit company.
The worrying signal here is the Committee’s failure to make its recommendations based on a full assessment of all the facts and a view of the overall landscape. Dr. Cook’s Working Group presented the best prepared recommendations we’ve seen in quite some time, but the failure to include target numbers and meaningful deadlines continues to be a problem.
Compromising to Get Along
The most disturbing thing about the meeting was the conflicting approaches of the CFSAC members. This was most on display during discussion of P2P and the RFA recommendation.
Dr. Cook explained that the reason the RFA recommendation included a reference to P2P was because the group believed NIH would wait for the P2P regardless of what CFSAC said. Therefore, the recommendation should just accept P2P as a done deal in order to avoid antagonizing NIH. Dr. Cook and Dr. Casillas, backed up by Dr. Nancy Lee, said the recommendation would fail otherwise. NIH has apparently sent a letter to IACFS/ME responding to their RFA request, and Drs. Friedberg, Cook and Lee all said that the letter states NIH will wait for the P2P before issuing an RFA (I haven’t seen this letter).
This conciliatory view was expressed most frequently by Dr. Gary Kaplan and Dr. Fred Friedberg (IACFS/ME). I copied down multiple statements from both. Dr. Kaplan said that CFSAC should be “more aligned” with NIH, making a “polite suggestion.” He said CFSAC should “be collegial so they’ll want to work with us.” He also said we have “nothing to fear” from P2P.
Dr. Friedberg was more emphatic. He said that the recommendation should not exclude something just because we might not like it, and that he doesn’t like us vs. them thinking. He said that the recommendation should “eliminate implicit antagonism,” and, “I don’t like the demand quality.” Regarding the prospect that CFSAC (or advocates) may not like some or all of the IOM and/or P2P recommendations, he said we should “make lemonade” rather than engage in “wholesale condemnation.”
The opposing view was expressed by Steve Krafchick, who said Dr. Kaplan’s collegial approach was “naive.” Dr. Mary Ann Fletcher specifically responded to Dr. Kaplan’s comment as well, saying that the CFSAC charter doesn’t say anything about getting along with NIH. She said that the Committee’s job was to advise the Secretary as experts in the field, and they they were not being fair to patients by putting things off to be collegial.
There was an inherent contradiction in the research recommendations, too. The recommendation on the data platform was passed with no discussion of cost or likelihood of success. There is a need for a data platform, so the Committee recommended it – and that is as it should be. But for the RFA, the majority felt that P2P should be accepted as part of the process simply because that is how NIH appears to be doing business, regardless of the fact that everyone agreed that RFA funding was needed now.
The worrying signal here was identified by Mary Dimmock (from the audience). She pointed out that it was a dangerous precedent to put forward recommendations that seemed likely to succeed, as opposed to the best recommendations that are most needed. I could not agree more. CFSAC’s job is to give the Secretary the best advice, not the advice that the Secretary or the agencies want to hear.
Moving forward . . . . together?
The last session of the meeting was facilitated by Deputy Assistant Secretary Anand Parekh. I was fascinated by the move to bring him in to lead this discussion. Was this a tacit recognition that Dr. Nancy Lee has had difficulty facilitating discussion about IOM, like the awkward session at the December 2013 CFSAC meeting? The other new development was an actual open forum. In the past, “open” discussion with the audience has been limited to the Chairman selecting questions that have been written on index cards. In this case, members of the audience were handed a microphone and they could address the Committee directly. I wish this had been more widely publicized (a simple email on the CFSAC listserv would have sufficed). I am probably not the only person who would have risked the health consequences to attend for that opportunity. Several prominent advocates had left the meeting by then, as well.
Margaret Jacobs from the American Epilepsy Association presented on the epilepsy community’s experiences with their own IOM report and subsequent cooperation with HHS. Because a number of epilepsy organizations helped fund that IOM study, they had input into the statement of work, received monthly status calls, and received the recommendations a week before public release so they could prepare their messaging. The cooperation before and during the IOM process laid a strong foundation for continued cooperation afterwards, with the epilepsy community and HHS working together.
The same is true for our situation: what happened before the IOM study is setting the stage for what will come after. HHS pursued the IOM study in secret without involving the stakeholders outside the federal government. The ME/CFS advocacy community found out about the contract by accident, and when we protested, HHS simply changed the contract mechanism to one that did not require public notice. There was no collaboration, no engagement, and communications were terrible.
Now HHS seems to think we can all come to the table and work together. I am deeply troubled by the fact that the government holds all the cards here. They will have about a week to prepare messaging on the IOM report, while we will have no opportunity to do so. The P2P report is issued pretty quickly after the meeting, but NIH will be in control of the press conference push behind the report. This simply isn’t creating a dynamic where the stakeholders can actually collaborate. I’m not sure if it will be possible, and the content of the IOM/P2P reports is only one factor in the way.
The worrying signal here is the open question of whether HHS actually wants to change the paradigm and is willing to do the work necessary. Dr. Lee said they “don’t want to do this without [community] involvement,” but if she means the kind of involvement we have had to date, then there is nothing to really talk about. It is going to take a great deal of work on both sides to change the trajectory here.
Dr. Parekh said twice that “there is a lot of angst among patient groups about IOM.” It’s not angst. We have legitimate scientific and policy concerns. Angst is easily dismissed as unreasonable anxiety. I do not know if HHS understands and appreciates the difference.