Highest Priority, Part Two

When I posted the other day about the CFS Advisory Committee’s list of High Priority Recommendations (pdf link), I said that I had done some digging and that what I found wasn’t pretty. To be blunt, what I found is that the secret process used to create this priority list violated established Federal procedure, including the CFSAC’s own Charter and Bylaws. By acting in this manner, the CFSAC has disenfranchised the very stakeholders they exist to serve: the patients. And if the CFSAC continues to act this way, then CFS patients will be deprived of the one venue we have to observe and shape HHS policy on our disease.

Making Sausage

Two sources close to the process have confirmed that the subcommittees generated the priorities for this document. Selecting from the Committee’s recommendations over the years, the Education/Patient Care/Quality of Life Subcommittee and the Research Subcommittee generated a short list of recommendations that they felt were highest priority. I have not been able to get copies of those subcommittee lists, so I don’t know whether their lists were combined into the final document without further editing.

But there’s a problem. At some stage in the process, either in subcommittee or upon final compilation of the document, recommendations were altered. The fourth recommendation in the document covers the issue of research funding, and here is how it appears in the High Priority document:

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. To accomplish this, specific issues would include:
a. Fund specific research for identification of biomarkers and etiology of CFS
b. NIH or other appropriate agency should issue a Request for Applications (RFA) for specific clinical trials research on chronic fatigue syndrome/myalgic encephalomyelitis. (5/11)

So it looks like this recommendation with two sub-parts was made in May 2011, right? Nope. This is an amalgam of three separate recommendations made at three separate meetings, and a sentence was deleted from one of them. Sub-part (a) has actually never been passed by the Committee with those precise words, but seems to be an edited version of a recommendation passed in October 2009. Sub-part (b) was passed by the Committee in November 2011. But the main part of this recommendation differs significantly from the version actually passed by the Committee in May 2011. The original recommendation ends with this sentence:

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.

That deleted sentence is critically important to the whole recommendation. It’s a statement by CFSAC that research funding must match the magnitude of the disease burden and that NIH should issue an RFA. The altered version that appears in the High Priority document says nothing about commensurate funding. It is a new recommendation created by smashing three recommendations from three different meetings together, deleting a critical sentence, and dating it all as coming from May 2011. I don’t know who did this. Was it done by one of the subcommittees? Was it done by Dr. Nancy Lee or other HHS personnel? There is no way to know, because this all happened in secrecy.

Behind Closed Doors

As a Federal advisory committee, the CFSAC can only make recommendations at open public meetings (barring a few exceptions not relevant here). The law requires that advisory committees discuss their recommendations in public, that they hear public comment on the issues, and then vote on recommendations in public. That is the whole point of the Federal Advisory Committee Act. But the CFSAC did not follow that procedure in creating the High Priority document.

Selecting the highest priority recommendations to forward to the Secretary is an issue that should have been discussed in public. The public should have had an opportunity to provide input on which recommendations we think are highest priority. We should have been able to listen to the committee deliberate and discuss why one recommendation should be selected over another. And there is no doubt in my mind that the entire committee should have voted on this High Priority list in public. This is especially true since the recommendation I examined above was materially altered and then combined with two other recommendations.

In fact, the process used to create the High Priority document violated both the Bylaws and Charter of the CFSAC. The CFSAC Bylaws state:

The advice of a subcommittee shall be reported to the full committee.  The full committee shall review reports and any recommendations made by the subcommittees.  Findings will be discussed at a public meeting of the full committee, at which time the full committee will determine appropriate action.

But we know that this did not happen. The advice of the subcommittees, in the form of the recommendations they designated as high priority, was simply compiled into the final document. And what happened next violated the CFSAC Charter:

The established subcommittees shall provide advice and/or make recommendations to the parent Committee. The subcommittees may not report its findings directly to any Federal official unless there is specific statutory authority for such reporting. (emphasis added)

But this is precisely what happened. The subcommittees selected their recommendations, the document was compiled, and then it was shared with Assistant Secretary Dr. Koh. Recall that Dr. Nancy Lee told me in her email of January 24, 2013, “CFSAC leadership discussed this priority list with Dr. Koh last year; he was very supportive.”

Who Cares?

Here is the problem: no one told us. The subcommittees made lists in secret. The lists were combined in secret. The final document was discussed with Dr. Koh in secret. This document was not discussed in public by Dr. Lee or CFSAC members, and it was not released to the public until this month – an entire year after it was created. In my opinion, this violates the Federal Advisory Committee Act, as well as the CFSAC charter and bylaws.

Why does this matter? Because the CFSAC is being held out as the main place we can offer input into HHS policy about CFS. In his letter to advocates on September 11, 2012, Dr. Koh said, “CFSAC provides a mechanism to ensure stakeholders are engaged and have opportunities to offer input.” Patients are not being included in other CFS-related policy efforts like the HHS Ad Hoc Working Group. We are constantly being told that CFSAC is the venue where we can offer our input.

But shenanigans like these – where the committee works behind closed doors and communicates recommendations to the Assistant Secretary without public discussion, public input or public vote – deprive us of our ability to participate in or observe the formulation of recommendations to the Secretary. If this trend continues, if CFSAC continues to do substantive work without bringing it back to the full committee in public, then we are effectively disenfranchised. We cannot allow that to happen without a fight.


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12 Responses to Highest Priority, Part Two

  1. Mary Dimmock says:

    Thank you for doing this, Jennie.

    There are so many things wrong with this situation its hard to know where to begin.

    Dr. Koh has stated that “CFSAC provides a mechanism to ensure stakeholders are engaged and have opportunities to offer input”.

    That CFSAC recommendations could be changed in this way with no communication for a year – and then not acted on anyway – is further evidence of how badly CFSAC is failing as an effective mechanism to engage stakeholders. Meaningful stakeholder engagement would never disengage ME patients in this way.

    We can not allow ourselves to continue to be disenfranchised and ignored.

  2. Katrina Berne says:

    Great investigative reporting and writing, Jennie! And bad news, as usual. We are still the unwanted stepchildren of medicine and government.

  3. John Bitna says:

    3 decades of being cheated and lied to.
    It’s time for a revolution.

  4. Jane L. says:

    Thank you for taking the time to work this out, to describe some of the hows and whys of CFSAC’s current state of dysfunction. Your article does work that CFSAC members should be doing – employing common sense to figure out how to make the most of its intended role (or at a minimum to not sabotage its reason for existing!) – but clearly are not doing. It struck me reading this that there has been a haste and a short-term desire to please in CFSAC’s actions that has led to cutting corners in a way that has helped no one. I hope CFSAC members and staff read this and take it to heart.

  5. Angel Mac says:

    Yes, I even remember at the end of the last Nov. 2012 meeting they were discussing the monetary amount that they should stipulate for the RO1 after putting out the calls for the RFAs… Where did that disappear to ?

    Also, if I rememer correctly, this next meeting they will be discussing their Charter again.. It seems it takes up every 4th meeting ? So we lose 1/4 of our time to discuss this illness… Anyway, what are WE as a Patient Population going to do this time. ??

    Also, I am TIRED of them NOT Notifying Everyone of when the meeting is so they can have time to prepare their Public Input, and they come out with the Agenda so LATE, HOW can one know what topic to address… it seems we must just ramble on about whatever we feel needs being HEARD ??

    I have written to Dr Lee numerously also, and I KNOW she got my points.. but just refused to address them or reply. She acts quickly enough during a meeting when I email her, but ZIP, ZERO, NADA as far as the CFSAC communicationg with those they represent after the meeting..
    I was even the one to finally complain and ask her to put a place on their website so we could sign up for email notifications when they made changes..
    I also 2nd your comment about how those issues were NOT disussed or “read in front of us during the meetings”.. I am on the West Coast and I have to get my butt up EARLY and I do it for BOTH Days to listen to the ENTIRE Meetings…
    IMHO we MUST write up something, that they should be ORDERED by the patients they represent, to INSERT AGAIN in the Charter that the Results of the Sub-
    Committees MUST be read OUT LOUD to the Pulic and then DISCUSSED so the pub;lic CAN HEAR THEM and KNOW what they are going to word ad their recommendations to the Sec. of HHS…. NO MORE “Closed Door” meetings changing the wording w/o making things transparent to the Public in a timely manner.

    WHO is the Chair this next time also ?

    I have asked Dr Lee, and Wanda before, her to PUT on the CFSAC Member page the Names+ their Position on the Committee, their Medical Qualifications for filling that position, a PHOTO of them, the dates they will be ON the Committee, and HOW TO REACH THEM !!!!
    I am TIRED of not knowing the players w/o their photos, names + dates or how to contact them… What a FARCE!!!

    Jennifer “my caps” are not cuz I am yelling at you.. I am just exacerbated at the CFSAC and aiming it at them… OK ?

    Also, may I PLEASE ask that you ADD a way for people to subscribe to get your blog via email ?? Many of us do not do RSS… Thanks.

    • Jennie Spotila says:

      I know you’re not yelling at me! ;D You should hear how much I yell at my computer when researching this stuff. Ok, to address some questions:

      None of the recommendations from 2012 are on the High Priority list because that list was finalized in January 2012. This begs the question why the CFSAC didn’t pull out the list at the June or October 2012 meetings and refer to it in making new recommendations. I have no idea why that did not happen.

      I share your concern about the late posting of the agenda. That’s something that I hope can be fixed. Public comment should not be due before we know what the agenda is!

      The Federal Advisory Committee Act already requires that subcommittees report on their work to the whole committee. which then discusses what action to take. That is not happening right now, and I don’t know why.

      The current chair is Dr. Gailen Marshall. He has been responsive to at least some concerns shared with him between meetings, and I know advocates are continuing to try to engage both him and Dr. Nancy Lee.

      The CFSAC members’ names and a photo of the whole committee is on the website here:http://www.hhs.gov/advcomcfs/roster/index.html I agree with you that it would be helpful to have each member’s bio. Some advisory committees do that, and in fact are encouraged to do so. I hope CFSAC will do it.

      Finally, I will look into how to allow email subscription. I am so plug-in illiterate, but I will try to make that happen.

  6. Because I live 90 minutes north of Washington by Amtrak, I have been able to attend every meeting of CFSCC and CFSAC since their inception.

    The biggest difference is that when it was CFSCC, back in the 1990s, there was a microphone at the head of the aisle and we were permitted to line up and ask questions – we, the public, the patients, parents, doctors – we could point out an obvious contradiction in a report by one of the ex officio members (representatives from the health agencies – CDC, NIH, FDA, HRSA …) and ask about information that was missing from their report.

    Without that privilege – which is a standard right in all other public meetings; just not for us – the reports from the agencies since 2003 have been sawdust, bland comments with little meaning and sometimes blushingly misleading. For example, a meeting never passes without NIH blaming the absence of funding for our disease on the researchers – saying they don’t fill out funding requests effectively, but assuring us that they’ll hold seminars to fix that. The statement is not only insulting, it’s not really true, because most “CFS” researchers have had no trouble getting funding for something other than CFS. They suddenly become all thumbs when it comes to our disease? Sounds like the fault lies within NIH, not the researchers.

    Without the ability to ask questions, we can’t verbalized a misstatement when we catch one, or ask a meaningful question and get it answered. I would really like to know why it is okay for CDC’s website to omit information about the large body of research into CFS regarding biomarkers (such as cytokine patterns); immune defects (particularly natural killer cell abnormalities and the 37kDa Rnase-L); viruses (particularly EBV, CMV, HHV-6A, and Coxsackie); cardiac abnormalities; hypothyroidism and hypocortisolism; the VO2 MAX stress test a the list goes on, but the first statement on that website that little is known about this disease is simply not true. After 25 years of research NOT involving CBT or GET, you’d think some of it should find it’s way unto that website.

    Or the website should not exist.

    They tell us our moment for commenting is during the five minutes they give us to testify – which may occur before the ex officio testimony, in which case you cannot comment at all. But commenting is not the same as being able to communicate publicly with the ex officio members. I have testified innumerable times about CDC, and once we shifted to the CFSAC format, my comments were simply ignored by Dr. Reeves and Dr. Unger. Pat Fero has gone to a great deal of trouble to research the paltry funds given out by NIH and testifies to that – then the NIH representative will stand up and say the same thing as always, with no reference to Pat’s findings.

    It has become a comedy of the absurd – we exist in parallel universes, with a glass wall between the committee and the public. I used to pass notes to friendly members of the committee who would then ask my question for me, but now they are actually FORBIDDEN to do that!

    And yet, CFSAC did pretty well, because public members of the committee such as Lenny Jason and David Bell worked hard to get serious recommendations up to the Secretary if HHS. It was frustrating that the only response we ever got from the Secretary, back in the last administration, was to have each ex officio member recite how their agency was responding to the public’s wishes – the same silly parade as before.

    Attending these meetings is not unlike the scene in “Animal House” where the undesirable at an open fraternity rush party keep getting sent back to the same spot with the rest of the “undesirables”.

    Now we’ve lost the one thing we had in our favor at CFSAC – committee membership who actually wanted to change things. For that reason, it is disconcerting that they have gone back to re-prioritize the previous recommendations. The first recommendations in 2004 were just fine. What needed changing?

    My mother – then in her mid-70s and in much better health than I have been – took me in my wheelchair to the first CFSCC meeting. I remember my mother listening for a few minutes to Bill Reeves say that the one thing we DID know about CFS was that it was not caused by a viral infection. Mom looked down at the Table of Contents for the meeting. “Who is this guy?” she asked. “It says here someone is supposed to speak from the CDC’s department of viruses and exanthums [diseases with pussy sores].”. That’s right, I answered. That’s who’s talking.

    “But he is saying that this disease is basically psychological.”. Yep. “Then why is he still in charge of it?”

    Mom had not listened to an ex officio report for five minutes before immediateoy gerting to the crux of the matter, the problem that haunts us everywhere in the US federal government. Here are a bunch of guys taking about psychiatric causation and feel-good solutions – and every one of them is an expert in something OTHER THAN PSYCHIATRY. (At NIH we were housed for years within NIAID, the National Institute for Allergies and Infectious Diseases, where virologist Steve Straus prided himself on being able to prove CFS was not related to viruses.)

    What passes for “science” at HHS with regard to our disease is what I can only call psychobabble. It’s not even serious psychiatry. [I don’t think a good psychiatrist would entertain the faux psychiatric theories put forward about our disease for an instant.] And when it comes to psychiatry, these heads of agencies are as unqualified as I would be – it is not and has never been their specialty. They are rank amateurs.

    The people at FDA evaluating Ampligen at this moment are out of their specialty, too – it is a committee on arthritis. If Ampligen works, then at least a subgroup of patients with this disease fall in the categories of immunity and virology. Not arthritis. Not TMJ (where NIH has sometimes put us).

    We are hidden in plain sight. At least for a while, we had a committee willing to fight that injustice. But the best way would be to once again allow the public REAL access to the agencies.

    We need the right to ask questions ourselves of the agency representatives in public. We need the right to be able to point out discrepancies. We need the right to get ANSWERS.

    And the questioning can start with why the government ignores all the existing evidence into pathogens, biomarkers, and objectively defined abnormalities, substituting instead popular psychiatry.

    • Jennie Spotila says:

      To your point about speaking from the floor or asking questions of the Committee, as far as I can tell that is not required by FACA. We have the right to “file statements” with the committee. Other forms of public participation in meetings is at the discretion of the Chairman and DFO.

  7. Leela Play says:

    What are the most effective ways for us to fight this? Can a complaint be filed to an HHS department?

    • Jennie Spotila says:

      Some of us are working on this, Leela. There are a few options, both crowdsource and legal ones. I will keep everyone posted as we learn more.

  8. Deborah Waroff says:

    The crud we get makes George Orwell look like an idealist.

  9. Pingback: Did CFSAC’s ‘High Priority List’ Illegally Bypass Public Input?

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