Spring CFSAC 2013 Meeting live streaming starting today - Weds 22 May

[akrasia]

Something very disquieting happened about a half hour ago at the CFSAC meeting. Eileen Holderman, close to tears, said she and two others, one of whom was Maryanne Fletcher, had been threatened by lawyers with expulsion from the committee for speaking their minds about the inadequacies, stonewalling, and high handed obstruction by the NIH representative, who wouldn't divulge how an important committee for an upcoming workshop was chosen. As I remember, Susan Maier said the selection of these "experts" came from "on high," and would divulge nothing else.

This is, of course, my characterization of what happened. Eileen et al, to my ears. were tough but polite.

Anyway, Eileen, if you read this, I think you did a splendid job over the last few days and at the FDA ampligen meeting.
BRAVA.

 

[Hope123]

Something very disquieting happened about a half hour ago at the CFSAC meeting. Eileen Holderman, close to tears, said she and two others, one of whom was Maryanne Fletcher, had been threatened by lawyers with expulsion from the committee for speaking their minds about the inadequacies, stonewalling, and high handed obstruction by the NIH representative, who wouldn't divulge how an important committee for an upcoming workshop was chosen. As I remember, Susan Maier said the selection of these "experts" came from "on high," and would divulge nothing else.

This is, of course, my characterization of what happened. Eileen et al, to my ears. were tough but polite.

Anyway, Eileen, if you read this, I think you did a splendid job over the last few days and at the FDA ampligen meeting.
BRAVA.

I suggest everyone who saw that and was disturbed by it write cfsac@dhhs.gov. Eileen is the patient representative so that makes her position all the more vulnerable. They can't bully us like this.

 

[Sing]

Without commenting on the substance of what she wanted to talk about because I don't know what those facts really were and they weren't fully presented, Eileen was trying to override the rules of the meeting in that instance with what she wanted to bring up, which the moderator responded to by insisting on sticking to those rules. My impression was not that he or anyone else in the meeting necessarily thought her subject was not important but rather that it was not in order then. Their exchange was certainly a dramatic clash of assertive statements on both sides, which I am sure a lot of people will want to hear.

 

[Mark]

Something very disquieting happened about a half hour ago at the CFSAC meeting. Eileen Holderman, close to tears, said she and two others, one of whom was Maryanne Fletcher, had been threatened by lawyers with expulsion from the committee for speaking their minds about the inadequacies, stonewalling, and high handed obstruction by the NIH representative, who wouldn't divulge how an important committee for an upcoming workshop was chosen. As I remember, Susan Maier said the selection of these "experts" came from "on high," and would divulge nothing else.

This is, of course, my characterization of what happened. Eileen et al, to my ears. were tough but polite.

Anyway, Eileen, if you read this, I think you did a splendid job over the last few days and at the FDA ampligen meeting.
BRAVA.

The way I interpreted it - and I may well be wrong, it wasn't easy to guess/interpret what went on there, it kind of came from nowhere from the observer's point of view but has clearly been bubbling away - was that the 3 (Eileen, Mary-Anne, and one other unknown to us) had been so threatened, by phone, by the Chair (Gailen Marshall) and that lawyers were involved; it wasn't clear to me on what side(s) the lawyers were involved. Also we don't yet have the full story (and probably won't get both sides) of what the reason for, and wording of those alleged threats was, and I don't know if it's true that the full reason was all about the criticism of Susan Maier and NIH per se or if they were more procedural issues that prompted this action (i.e. the way things were said).

Re: the selection of the NIH committee: Maier explained that the people who decided who would be chosen to form the new workshop working group were internal NIH staff and it appeared that she was not in a position to divulge who they were. She also explained that those people had chosen a variety of clinicians, physicians and patient/advocate/org reps to a total of 30 or so people who would then be formulating the questions for the workshop. That list of names, IIRC, is also not yet public, but I think she said it soon will be. I'd have to check my notes...will do so later. I'll be attempting to write something up on the CFSAC meeting this weekend; I took extensive notes.

For what it's worth, I too appreciated Eileen and Mary-Anne's contributions at the meeting, but I also believed (and believe) that Susan Maier is indeed very sincere and honest in what she's said to the committee and that she works very hard, as she says, and is in a very difficult position in advocating for ME/CFS within the FDA. I think it's really important to recognise the distinction on the committee between the other committee members and the federal reps. The federal reps are there in a capacity whereby they represent their department, it's part of their job, their hands may often be tied to a considerable extent, they say and do what they can, and they are a go-between between the committee and their departments. I really think that most or all of them are probably there because they care a lot about ME/CFS - and indeed understand and buy into the political issues that concern the committee - far more than anybody else in their departments. They also, however, recognise a whole load of wider practicalities in terms of how their departments function and operate, and they try to translate what the committee says into the reality on the ground in their departments. I think extended conversations on the committee with those reps are important, and pressing them on details is certainly important, those conversations are critically important, but a degree of trust in the individuals involved (even if not, necessarily, their departments) is appropriate. I have never seen any reason to doubt the good faith of those individuals while I've been watching CFSAC (which is about 3 years now), and Maier in particular has struck me as a very committed individual.

So what happened was a great shame, but perhaps it's just to be expected that the extraordinary tension, which flows from a spectrum from patients and physicians at one end, through the committee and on the the federal departments at the other, has to have a point of tension somewhere, when there is such a huge disparity between the way the two ends of the spectrum see things. It's extremely difficult to work across and through those lines of communication, but also extremely important to try to do so, and I greatly respect everyone involved for their commitment in being involved in doing that.

 

[akrasia]

Without commenting on the substance of what she wanted to talk about because I don't know what those facts really were and they weren't fully presented, Eileen was trying to override the rules of the meeting in that instance with what she wanted to bring up, which the moderator responded to by insisting on sticking to those rules. My impression was not that he thought or anyone necessarily thought her subject was not important but that it was not in order then. It was certainly a clash of assertive statements on both sides.

Sing,

This wasn't about Eileen's desire to give her report on the sub committee she headed. To my ears it was about some of the questions being posed by Eileen, MaryAnne Fletcher, and another person.

As you say, it's well within Gailen Marshall's remit to keep the meeting in order but that was at a different point. It's government lawyers threatening expulsion of the patient rep and a staunch ally like Fletcher that is deeply troubling. I
expect we will learn more of what happened. At the moment, it looks very bad to me...

 

[JayS]

Eileen said the threats came from the DFO (Nancy Lee, who replaced Wanda Jones), not the Chair. Mary Anne said she'd been threatened with being removed--I think she said 'eviction'--from the Committee. Susan Maier doesn't advocate within the FDA, as she's the NIH rep.

 

[Nielk]

I would like to adopt Mary Ann Fletcher as my mother and Eileen Holderman as my sister.

This is weird. I wrote this in the morning and now I read that they were both threatened? I have been watching the whole time and missed the last hour so I have no idea what happened.

 

[Nielk]

Eileen said the threats came from the DFO (Nancy Lee, who replaced Wanda Jones), not the Chair. Mary Anne said she'd been threatened with being removed--I think she said 'eviction'--from the Committee. Susan Maier doesn't advocate within the FDA, as she's the NIH rep.

Do you know for what reason they were threatened?

 

[LaurelW]

It seems to me that there is always a bit of a spat of some kind on the afternoon of the second day. People are exhausted, the material to be gotten through is pretty heavy, and people get snippy. I just hope it all sorts itself out.

 

[Nielk]

You can read Marry Dimmock's testimony here.

 

[JayS]

Do you know for what reason they were threatened?

No, but it sure doesn't look good.

 

[jspotila]

Eileen said the threats came from the DFO (Nancy Lee, who replaced Wanda Jones), not the Chair. Mary Anne said she'd been threatened with being removed--I think she said 'eviction'--from the Committee. Susan Maier doesn't advocate within the FDA, as she's the NIH rep.

And I will add that my understanding of what I saw/heard was that one or more of the three committee members who felt intimidated had talked to lawyers. I did NOT hear Eileen say that she was threatened or intimidated by an HHS lawyer.

 

[Sing]

Mark, Jay, Akrasia and Jennie, thanks for responding and helping to add more to our understanding so far.

I am also remembering now how Susan Maier said she had been mocked for her work on this committee by ? others in her agency? And that Dr. Ken Friedman had brought up how he had lost his position in an academic institution, as had another man he knew also doing research on ME/CFS. Hope I am getting the details right. These were all our doctors, advocates and researchers being put down or threatened in some way for pursuing this work. (Probably there would be a lot more stories like this which could be told.)

To me this was poignant in how they too share in our experience of being disrespected and sometimes worse. All these individuals deserve an opportunity to communicate about what happened. But in terms of this meeting and its agenda and rules, I think they could only squeeze some of this in "sideways", within other agenda items, timing and rules, and so it was indeed frustrating. To me this leaves more unfinished business and provides even more reason why it is so important for us to gain a respected place in the medical field.

 

[akrasia]

And I will add that my understanding of what I saw/heard was that one or more of the three committee members who felt intimidated had talked to lawyers. I did NOT hear Eileen say that she was threatened or intimidated by an HHS lawyer.

Thanks for the clarification. I found much of the meeting difficult to heàr. The point, in the end, is that they were threatened.

 

[Dolphin]

One person posted this on Facebook and said no credit to her was necessary for re-posting it:

1. WOW! Eileen Holderman "afraid"! "Being shut down"..."hijacking the recommendations, you don't like my poiint of view, PFO calling her and two other members, it's wrong."
   
   MaryAnn Fletcher says she's also one of the Members under threat!
   
   Dr. Meier saying she has been intimidated also. "Worked every frikken weekend for you, people telling me I am wrong, ...being misquoted."
   
   Krafchick: What Eile...en said is disturbing...most critical things we can do is to recommend a case definition..start with CCC, one used by IACFS...for clinical or research, it has to start somewhere...it doesn't cost anyone anything to say it can be an interim definition...
   
   Levine: Most are using the CCC
   
   Krafchick: so what's the harm of adopting it now?
   
   Gailen: See if we can defuse. Working group could be 3-6, one in response to NIH request to investigate strategies used to fund researchers into ME/CFS, how HHS might make partnerships...the Sec. needs more info on recommendations, group needs to be willing to do the work.
   
   Jason: 10 yrs ago, two proposals of alternative strategy, now research will be funded same way, which has NOT resulted in treatment, care, diagnoses, cure. Are alternative strategies being dismissed?
   
   Gailen: Nothing to do with any one specific topics: Sec. telling us we need to have more evidence based Rec. for Sec. to act upon, use Workgroups, not specifically subcommittees, that doesn't dissolve them.
   
   Second is to develop care for ME/CFS patients; develop the speciality of ME/CFS medicine (hypothetical); to fund and bring the Amer. Coll. of Ped., Family Med., find the barriers and Lori Chapo's email very valuable, try to find solutions to getting more providers who want to and are capable of treating patients. They have done the wrong thing out of ignorance; they are learning things in the wrong way, are harming them, need to find way to teach them the right things. (Getting the Primer out to them; all AU drs have it; why don't U.S. docs?)
   
   We need more specialists, but we need more Sue Levine's and Nancy Klimases.
   
   Increase number of interested and capable expert providers, nurses in there as well, for treating ME/CFS patients. To at least recognize the patients, be capable of looking at them, diagnose them, etc.; medical student education, etc.
   
   Continuing medical education, change current behavior; ACGME, those learning how to be specialists and medical students. All three needed.
   
   ??: "Need the new generation of new docs to learn...and doc at any clinic, can see it and refer to local more experienced clinicians...
   
   Primer under revision with info re Severe patients, with input from them.
   
   Holderman's subcommittee: topics, MEICC, CDC content, ICD CF10; Primer, Case Definition, Most Severely Ill; Legal Issues, SSA Disability, Scholarship Programs, Provider Education, CME online course, and highlighted, the private research centers. Mt. Sinai, Nova, CFI in NY, Montoya at Stanford's CFS, and Enlander about ME Ctr at Mt. Sinai. People who provided videos; jessica taylor and peter and chris cairn, and others thanked. Applause.
   
   Kim McCleary thanked FDA asked for more from them and CFSAC re treatments.

(I wasn't listening myself)

By the way, who is Jason? Leonard Jason?

 

[jspotila]

One person posted this on Facebook and said no credit to her was necessary for re-posting it:
(I wasn't listening myself)

By the way, who is Jason? Leonard Jason?

No, it was not Leonard Jason as he wasn't there. Based on my notes, I think it was Ken Friedman who said that.

 

[Dolphin]

Ken Friedman and Leonard Jason are both bald men - I wonder whether this is causing any confusion?

 

[Mark]

Eileen said the threats came from the DFO (Nancy Lee, who replaced Wanda Jones), not the Chair. Mary Anne said she'd been threatened with being removed--I think she said 'eviction'--from the Committee. Susan Maier doesn't advocate within the FDA, as she's the NIH rep.

Thanks for the clarification JayS, I wasn't clear at the time exactly where the alleged threats were said to have came from and apologies if I caused any confusion. Also sorry for my oversight in mistyping FDA rather than NIH in part of my comment above.

 

[Mark]

It seems to me that there is always a bit of a spat of some kind on the afternoon of the second day. People are exhausted, the material to be gotten through is pretty heavy, and people get snippy. I just hope it all sorts itself out.

Well said; yes I do agree that the pressure and exhaustion are part of this. The business end of CFSAC always seems to be time-pressured in the last couple of hours and I do wonder whether the agenda could be organised differently to avoid that, but perhaps it's inevitable. There's some kind of dynamic there whereby there are pressures that eventually blow at some point. Frustrations build up over the course of the two days and when time starts to run out, that comes out.

 

[Mark]

And I will add that my understanding of what I saw/heard was that one or more of the three committee members who felt intimidated had talked to lawyers. I did NOT hear Eileen say that she was threatened or intimidated by an HHS lawyer.

Thanks Jennie; that's how I heard it too and that was the main thing I was trying to clarify in my earlier post.