P2P FOIA Documents, Part 6—”File all these responses. No need to answer them directly.”

Here are more P2P emails that were produced to me after I won my IOM FOIA lawsuit. Today’s documents are NIH and AHRQ emails relating to inquiries from the public regarding the ME/CFS P2P program and the “TPs,” the talking points NIH developed as a canned response to any—and I mean any—inquiry regarding the program, regardless of whether the talking points were actually responsive.  Please keep in mind that NIH’s P2P document production in response to my FOIA request is in violation of FOIA in numerous respects (e.g., regarding exemptions claimed) and that, based on the agency’s past behavior, there are likely documents regarding the talking points and public inquiries that have not been produced or that have been “misplaced.”

This batch of emails starts with somebody within the agency—clearly entirely unfamiliar with the agency’s P2P (then EbMW) program—consulting the patient forum, “ME/CFS Forums,” to educate him or herself (page 2):

This inquiry came in about an EB ME/CFS workshop. Are you familiar with this? A quick Google search resulted in the following site that discusses the workshop in detail [link to ME/CFS Forums] and mentions ODP providing funding. I didn’t have much luck finding information on NIH’s site about the workshop. [emphasis added]

I guess the secrecy about the program extended deep into the agency itself, as confirmed by Paris Watson who is in charge of the ME/CFS P2P program (page 1):

We have a policy to keep things under wraps until the Steering Committee has finalized the agenda and speakers have accepted our invitations to participate.

(The “Steering Committee” was later renamed the “Working Group.” It is anybody’s guess how many resources went into that. No documents relating to that name change have been produced. I guess they got lost in file 13.)

Watson goes on to say in her email to Susan Maier (page 1):

Given the public interest in ME/CFS, I thought it would be wise to field these inquiries through you, ORWH, or the Trans-NIH ME/CFS Research Working Group. [emphasis added]

(The Trans-NIH ME/CFS Research Working Group is not to be confused with the ME/CFS P2P Working Group.)

Notice the choice of words here. It’s not “answer” or “respond to.” It’s “field.”

And why, if NIH is so concerned about the “public interest” in ME/CFS, does the agency never do anything to actually advance quality research in the area? Why is it always about window dressing  and public perception only instead of real progress?

Susan Maier further confirms the institutionalized secrecy (page 1):

Yes, please send those queries to me. I usually coordinate the MECFS messages from NIH out to the public.”

Pre-approving or channeling all inquiries through one person is indeed the best way to avoid somebody going off script and accidentally giving away the real agenda of NIH with respect to ME/CFS.

Also please note Watson’s instructions to the communications team linked to in my prior blog post, “P2P FOIA Documents, Part 4–NIH: Neither Patients Nor Science Meant to Be Part of P2P:”

If *any* inquiries come in regarding ME/CFS, please forward to me and do not reply.

Beth Collins Sharp from AHRQ, in a clear attempt to placate a stakeholder, had the audacity to suggest that the P2P approach will actually give experts and stakeholders any meaningful input (page 6):

I just don’t want to suggest how the EPC will approach it before they’ve had a chance to dive in and hear from the experts. But based on my past experience, I feel confident that they will listen closely to stakeholders, then consider the evidence objectively and analyze it carefully.

This is blatantly misleading. Clearly Collins Sharp, when she wrote these disingenuous words, was likely well aware that the report that would be prepared for AHRQ, her agency, would come from non-experts (and without any apparent input from experts) and that the P2P rules prohibit any experts to be on the panel, not to mention the fact that there has not been and won’t be any input by patients. The only patient on the working group (which finalized the key questions, nominated the workshop speakers, etc.) will not be on the panel and, in any event, has no buy-in or support from the community at all. In fact, he was brought into the process in absolute secrecy without any knowledge by the patient community. Why?

Collins Sharp proceeds with her PR campaign (page 6):

The public comment at the workshop is at the end of the process, but let me quickly add that the expert panel is convened by the NIH at the very beginning for topic refinement and that it includes the patient perspective.

Too bad that Paris Watson contradicts this statement 100% by making it very clear that patient input is really not at all meant to be a relevant part of the process:

… I don’t think members of the public or advocacy groups are appropriate. However, it is appropriate to have a ‘patient perspective’ open the workshop. That would be a nice nod to the advocates (and may quiet the inevitable ‘where were the advocates?’ ‘why weren’t patients included as speakers”). (page 191 at the above link)

We encourage advocates to come to our meetings and participate during the town hall discussions, but please know that we really don’t allow for long commentary.(page 189 at the above link)

Collins Sharp proceeds (page 6):

I hope that there is also buy-in once folks see that it’s a genuine effort to move the science along. I know there is skepticism at this point.

A process so ludicrous as to preclude all meaningful expert input tends to result in skepticism. Instead of addressing the deeply flawed P2P rules, the public is fed platitudes about alleged genuine efforts.

In a later email in reply to a message from Maier that was basically entirely redacted, Collins Sharp all but outright admits that she was purposefully non-specific in her correspondence with the public (page 4):

… and the areas where I was vague were in line with your approach.

In line with Maier’s approach!

Collins Sharp, in another email with a member of the public, claims that the working group that finalized the P2P key questions will consist of mostly experts (page 13):

However, it is important to note that the EPC work will be guided by the key questions refined by the expert committee.

That is another questionable statement at best given that the working group consists of 7 non-Feds (one being a patient and one being a non-ME/CFS expert) and 12 Feds. In other words, experts represented in the working group made up less than a third of the group.

More misinformation by Collins Sharp in an email to the member of the public here (page 9):

… I am familiar enough with both processes that I am confident that the experts will have an opportunity to present the definitional issues and that they will be listened to carefully. That being said, there can be sharing of research resources between projects.

Why are we then told, by the IOM panel chair and others, that sharing of information between the IOM and P2P projects is against the rules?

The secrecy scheme broke down when Maier told a member of the public in December of 2013 about the working group meeting scheduled for January 6th and 7th, 2014 (page 12). Inquiries from the public about that meeting started coming in on January 6, 2014  (page 15):

And I thought this meeting was under wraps!

Once more and more questions from patients and other stakeholders were asked, NIH seemed to realize that it needed to keep tight control over the “message.” In one instance, Maier facetiously stated internally after another inquiry from the public (page 24):

Yay!

NIH had to put an end to these questions. Therefore, the decision was make to come up with talking points (page 22). That was immediately followed by NIH’s favorite theme, food (page 22):

We should have lunch soon.–Paris Watson

Once the concept of the talking points was agreed on, James Anderson, NIH Deputy Director, (i.e., from the office of Francis Collins, Director of NIH), micromanaged the process to the point of making edits to them. That is the degree of detail to which Collins and his office have been involved in the P2P. Not only did the talking points have to be approved by Anderson (pages 27, 33, 34, 39), but they were actually revised by him. Of course, the actual changes made by Anderson were redacted. They seem to relate to distorting the message about the overlap between the IOM and P2P programs.

What is of minor interest is that Mariela Shirley seems to lack self confidence in her new role and has Maier ghost write the message to Anderson (page 356. She then asks Maier if she may use “we” instead instead of having the message come from her alone (page 35):

Can I use the proverbial “we” vs. just me??

When Maier told her to use “I,” Shirley replies (page 35):

Ok … as long as JA [James Anderson] doesn’t just come after me! (page 34)

Maier reminds Shirley’s that there is no way to keep Anderson (i.e., Collins) out of this (page 34):

We have to involve his staff.

Shirley finally sends her message to Anderson seeking clearance for the talking points (page 39). She also makes the following remarks:

Please note that even prior to when the P2P working group planning meeting ended at noon on Tuesday, the Blogosphere and Twitterverse showed significantly heightened activity and discussion about the ME/CFS Pathways to Prevention Program. Despite informing participants at the most recent CFSAC public meeting about the purpose of the P2P meeting, the P2P processes, and meeting dates/location, the advocacy community is expressing considerable criticism and concern that the P2P meeting and processes are colluded and private.

Right, and the way to address and alleviate those concerns is to disseminate canned talking points. Only in the HHS universe does this make sense.

Shirley’s “wow” in response to Anderson’s requested edits is telling (page 38). Maier doesn’t seem thrilled:

We can think about the merit of the change. (page 38)

David Murray, Director of the Office of Disease Prevention then provides more sales-pitch language to Watson to be used by NIH to explain away the duplication of efforts by the IOM and P2P by first saying that P2P is aimed at research and then stating the following (page 50) :

The IOM effort will [] review the various definitions for ME/CFS. However, their goal is to develop and recommend diagnostic criteria and case definitions for clinical care. Their audience will be health providers, patients, and caregivers, not researchers.

Our planning had been underway for sometime when we learned of the IOM’s interest in this topic. We have been communicating with them to avoid duplication of effort.

I believe it was at the last CFSAC meeting when Nancy Lee betrayed that talking point and told the public that the IOM is also going to address a new research definition. Funny that, huh! Because that is the exact opposite of what Murray said above and what we have been told in terms of there not being any overlap between the IOM and P2P efforts and, most importantly, of the language that made it into the final talking points (page 99).

Another telling quote by Maier (page 60):

I would rather start small and add to the content that [sic] have to battle the release of longer more complex content.

This is the same advice defense attorneys give their clients before they take the stand: The less you say, the better. Because you are less likely to get caught up in inconsistencies.

More secrecy from Maier here (page 64)

I think we are in agreement that we are not releasing the panel names until the first day of the workshop (Dec 2014 )…

Why is the identity of the panel members such a secret? What is NIH afraid of the public will find out about those panel members or tell them? Moreover, NIH is not even making an effort to pretend that it has conducted conflict-of-interest checks of the panel members.

And then the infamous fasten-your-seat-belts quote by Maier (page 64):

Fasten your seatbelts [sic] and return your tray tables to the upright position because its’ going to be a bumpy ride :-)

That smiley face is from the actual email.

Once the talking points were finalized, instructions by Maier to Shirley for their use (page 81):

Response needed. Can you send the TPs? Keep a record of these transactions and do not include any other name but yours (not even as BCC). If you want to send to someone as a heads up, forward your response to the email to that person(s).

No copies, not even blind copies! That’s how you create deniability. For Congressional, FOIA and other purposes.

Then the official roll-out of the talking points within the agency (page 95):

Please confine your responses to the content in these talking points.

The formatting (bold and underlined font) is from the original email. I guess the do-not-go-off-script message really was important.

The talking points were then sent as a reply to any inquiry whether or not they were responsive. Patients complained about that and asked for clarification:

None of the information you sent me answered my questions. (page 117)

I must respectfully point out that you didn’t answer any of my specific questions. (page 121)

… my questions concern how the NIH P2P panel that will be writing the final document will be selected. … I hope you can expand on my questions … (page 124)

Maier was like, “yeah, right!” (That is not an actual quote.) In an email to Shirley, she dismissed those patient inquiries coldly (page 124):

File all these responses. No need to answer them directly.

And that’s how you effectively keep total control over a genie that you know you can’t put back into the bottle if somebody accidentally frees it.

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P2P FOIA Documents, Part 5—ME/CFS P2P Violates NIH Rules, Woot Woot!

Starting in August of last, year, NIH went through the elaborate process of rebranding the program that had until then been known as the Evidence-based Methodology Workshop (“EbMW”). The new shiny brand that emerged after an enormous bureaucratic effort—whose necessity is less than obvious and that would make Monty Python proud—is “Pathways to Prevention” or “P2P.” And here are emails* letting us watch the unfolding of this comedy-drama.

The emails linked to in this post will provide as much comic relief (Just stick with it; the funny parts are in the second half.) as they are bound to provoke some outrage about NIH’s comfort level in wasting valuable taxpayer money on window-dressing projects when ME/CFS desperately needs, more than any other disease, some serious financial commitment from NIH to ME/CFS research. It will never cease to amaze me how there is somehow money to be found for paper-pusher projects, such as this one, and yet nearly no money at all for research of a disease that causes suffering beyond comprehension. NIH’s support for ME/CFS is just not forthcoming aside from the psychosocial Fred Friedberg-type of “research” of the “Efficacy of Home-Based Self-Management of Chronic Fatigue.” And yet, a total of  at least 12 NIH employees, including David Murray, Director of the Office of Disease Prevention, and who knows how many hours were committed to this project. Murray, by the way, refers to our disease disrespectfully as “chronic fatigue” (page 74).

But more interesting than this ludicrous name-changing exercise is the fact that the linked-to documents clearly betray the intent of NIH in using P2P for our disease. It becomes obvious that NIH—in utilizing the P2P mechanism—is violating its own P2P rules. Quoting from the document “About the National Institutes of Health Pathways to Prevention (P2P) Program (Page 33):

P2P workshops are designed for topics that … are generally not controversial.

The following major criteria must be met for a topic to qualify for a P2P workshop:

  • Have a primary or secondary disease prevention focus.
  • ….

First off, everybody familiar with the disease knows that it is as controversial as it gets. In fact, in the proposal by the Office of Disease Prevention for holding a P2P workshop for ME/CFS, the topic “controversy” took up a long paragraph (page 76).  Of course, this controversy has been purposefully manufactured by HHS, but nevertheless, patients have to live with that surreal reality now.

When NIH’s own rules prescribe the use of the P2P process only for diseases that are “generally not controversial,” using it for the most controversial disease of our time cannot be explained away by attempting to argue that the rule only applies “generally.” That would be letting the exception swallow the rule in the case of a disease that is clearly not suited for the P2P mechanism.

In terms of the disease-prevention focus, that requirement is also clearly not met here. We do not know the cause for ME/CFS nor do we know much about treatment and certainly nothing about a cure. How does one possibly envision prevention at this point?

There can be no doubt that applying the P2P process to ME/CFS violates NIH’s P2P rules. Plain and simple.

Now on to the documents regarding the name-change from EbMW to P2P. From an agency-internal email (page 1):

I think the words Evidence or Research or Science should be in the title somewhere, because they all imply evidence-based assessment going on.

You have to appreciate how, even in internal correspondence, the Feds pretend that they believe their own baloney. Although that is only going to get worse now that they likely understand the power of FOIA better. But evidence-based assessments are the opposite of science when it comes to sparse or biased “evidence,” as is the case with ME/CFS.

And now the fun parts.

For your entertainment, here are some of the new names NIH considered for EbMW (page 2):

Evidence-based Prevention Science Workshop (EbPSW)

Evidence-based Prevention Research Workshop (EbPRW)

Evidence-based Prevention Assessment Workshop (EbPAW)

Prevention Research Assessment Workshop (PRAW)

Prevention Research Evidence Assessment Workshop (PREAW)

More ideas here (page 1):

Prevention Research (PR) workshops

Prevention Workshops (PW)

Or something “Mind the Gap”-y like

Next Steps in Prevention Research

Advancing Prevention Research (APR)

I swear, the “Mind the Gap-y” language is a direct quote.

And yet more suggestions (page 11):

Prevention Research Assessment Workshops

Prevention Research Assessment Program

Advancing Prevention Research Workshops Series

Advancing Prevention Research Workshops

Some internal reactions:

moar words (page 3)

Whopper? (page 7)

And here are the Feds getting obsessed with coming up with acronyms that are an actual word (page 12):

Prevention Research Opportunities Under Development (PROUD)

Prevention Research Opportunities for Development (PROD)

Prevention Research Opportunities Program (PROP)

Gaps in Research Assessing Science Program (GRASP)

Gaps Assessment of Science Program (GASP)

Gaps for Research Opportunities Workshops (GROW)

Gasp indeed! And they were not done yet:

How about PRAWN? I don’t know what N is for but I am hungry. It rhymes with YAWN. (page 6)

Food seems to be a big theme at NIH. Many of you will remember that Susan Maier complained, during the January IOM meeting, about not getting her lunch paid for. I do sort of understand the association with “yawn” though, as I would rather eat nails (Yes, I do watch a fair amount of Pippi Longstocking.) than do “work” that entails *this.*

And just when you thought all rationality had left the agency, an unexpected twist (page 11):

I agree that the acronyms don’t have to spell out a word. It’s nice and cute, but ultimately the priority should be on making sure the name appropriately reflects the program.

Way to get a hold of reality again!

And then there is this mind-blowing disclosure (page 6):

Didn’t we spend hours at my white board trying to do this and got nowhere?

Hours! Nowhere! Wait! What?

Pepe the King Prawn even makes an appearance as a suggestion for the program’s mascot (page 6). And although these folks all likely reside in the DC area, they certainly have the valley-girl lingo—or whatever this is—down:

OMG … I LOVE YOU SO MUCH (page 6)

WOOT WOOT (page 14) 

Best. News. Ever. (page 14)

Yay go team!! (page 16)

me likey (page 27)

That “Woot Woot” formatting is copied from the actual email.  The “me likey” is a lot less funny if you consider the racist undertones. Both of those remarks (together with the “I love you” comment) are from Paris Watson, Senior Advisor of the Office of Disease Prevention. The P2P was her “brainchild” (page 9).

Once a consensus on the new name was finally reached, here is how it was sold to Murray (page 14):

The title “Pathways to Prevention” speaks directly to the goal of the program – providing a mechanism to advance prevention research.

Right, because that’s how it’s done at NIH. If you go straight to preventing a disease, you never have to worry about the etiology, treatments or a cure.

And then there were burning questions regarding loose ends, such as:

Word selection: Does each workshop “result in” or “produce” an evidence report and panel report? (page 21)

You cannot be serious!

And, of course, a new logo was needed (page 27) and a bunch of documents had to be revised to reflect the change from EbMW to P2P (page 25):

1. P2P Summary for Web

2. P2P FAQs for Web

3. P2P IC Coord Responsibilities

4. P2P Panel Cair Responsibilities

5. P2P Panelist Responsibilities

6 P2P Working Group Responsibilities

7. P2P Web Pages (landing pag for workshop planning process)

8. P2P EPC FAQs

9. P2P Timeline (.ppt)

Aren’t we all glad that NIH has the money and manpower to “invest” in such a high-priority project, the EbMW-P2P rebranding? And the resources to waste to make fun of patients whose lives have been ruined? Quoting Jessica Wu, a Fellow at the Office of Disease Prevention (page 2):

… of course, there’s always the Watson Program. Or we could do something like reality TV show voting, complete with texting and 800 numbers.

And Paris Watson in reply (page 4):

I am always happy to make a game show out of this, as Jessica recommended. I have a fancy dress all ready.

I think I’ll have some prawns now.

_______________________

*Please remember that the only reason we have access to any of the P2P documents that I have been, and will continue to be, publishing is my winning the IOM lawsuit (except for those documents I published with my first blog post on the subject). Without that, we would not be privy to any of this information. While my P2P FOIA request was separate from my IOM FOIA request and subsequent lawsuit, NIH sent the P2P documents shortly after losing over IOM in court. There is no doubt in my mind that this was a damage-control move since the NIH FOIA staffer knew that her meager production in response to my P2P request was inadequate, similarly to her and the HHS’s FOIA staffer’s production in the IOM case, which the latter got called out for by the court in its ruling (because, even though her FOIA violation was just one of many, it was one of the most egregious ones in this case). The NIH FOIA staffer was trying to avoid meeting the same fate as her HHS counterpart. It is a sad state of affairs that NIH needed an embarrassing loss in court before providing these documents, something the agency was obligated, under the law, to produce without dragging a patient through expensive litigation.

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Federal Court awards $139,147 in Attorneys’ Fees Against HHS and NIH in IOM FOIA Case

The U.S. District for the Northern District of California awarded me today–having won my FOIA lawsuit–my entire attorneys’ fees in the amount of $139,147. Judge Vince Chhabria ordered the defendants, HHS and NIH, to pay me these fees. Please see below for a copy of the order.

In the Court’s order, the Judge noted:

Ms. Burmeister is clearly the prevailing party in the litigation. Moreover, as outlined in the order granting Ms. Burmeister’s motion for summary judgment, the government’s conduct throughout its dispute with Ms. Burmeister was unreasonable.  Ms. Burmeister stood to gain nothing financially from her attempt to obtain documents at issue from the government, and she conferred a benefit on the public through her successful effort to obtain a ruling against the government. [emphasis added]

The defendants’ conduct in this matter has been absolutely deplorable. They have fought tooth and nail trying to avoid compliance with federal law and to delay production of relevant documents relating to the IOM project as long as possible. Throughout the entire proceedings, the defendants have acted unreasonably and shamefully, really, in their relentless attempts to circumvent their obligations under FOIA. Their inexcusable conduct has put me through the wringer, which has had a direct and dramatic impact on my health. I will share with the community, at a later time, details of the many instances of the defendants’ appalling actions in this matter. But here is a high-level list:

The defendants failed to make a determination in response to my FOIA request (from more than a year ago, seeking documents relating to the IOM contract with HHS) within the 20 business days required by FOIA. I waited several weeks and sent them one last communication notifying them that legal action was imminent. When they still did not respond, I brought my suit pro se, i.e. I was representing myself in an attempt to avoid attorneys’ fees. After I filed the lawsuit, defendants produced a mere 88 pages, only 22 relating specifically to the IOM (one of them blank), for a very high-priority and extraordinarily controversial $1 million project. It was clear that their search and production of documents was woefully inadequate (as the Court later agreed when it granted my motion for summary judgment). The defendant’s subsequent response to my complaint was, once again, late. It was then that I realized that they had no intention of complying with the law in response to my entirely reasonable and very straightforward FOIA request, even faced with a lawsuit. Therefore, I hired the law firm of Baker & McKenzie LLP.

Every taxpayer dollar spent by HHS and NIH in this lawsuit–every single one–was caused by the government’s appalling tactics. Instead of remedying the inadequate search and production, they went into full-blown attack mode, filing a meritless and unwarranted motion, making frivolous legal arguments, making false statements under penalty of perjury, misrepresenting my statements and actions, misrepresenting legal authority, etc. They went so far as to accuse me of lying under penalty of perjury, which shows their mindset very clearly: Since they had no qualms about blatantly misrepresenting the facts, they thought accusing me of the same might work. It didn’t.

A few days ago, in response to the Judge’s order from September to produce all documents  I sought, Counsel for defendants delivered about 4,300 pages of supposedly responsive documents demonstrating very clearly the laughable number of documents originally produced. A cursory review of those documents shows that their misrepresentations–again made under penalty of perjury and in opposing Counsel’s motions–were far worse than it initially appeared. It is also obvious that this new production is again inadequate and does not comply with FOIA in many respects.

The community will be extremely interested in seeing the documents that they produced recently. I will make every effort to publish those of interest (I will save myself the energy of publishing the NICE guidelines or the IOM Gulf War Report from earlier this year.) as quickly as possible, but my health has been very poor as a result of this litigation, so I ask for some patience.

I want to thank Patricia Carter, the owner of MECFS Forums, for providing a helpful declaration in support of my attorneys’ fees motion. I also want to especially thank Eileen Holderman, the former and most effective patient representative on CFSAC in its history, for her invaluable assistance, including providing a declaration in support of my motion. Finally, my sincere thanks go to my attorneys, Bruce Jackson, Edward Burmeister and Christina Wong, as well as paralegal, Nada Hitti, and assistant, Chris von Seeburg, for their unflagging efforts and excellent representation in this case.

PS: I owe the entire amount to Baker & McKenzie and I would have had to pay it regardless of whether the Court had awarded me the fees. I guess what I am trying to say is that I don’t get to keep the money, just to avoid a misunderstanding on that front.

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P2P FOIA Documents, Part 4–NIH: Neither Patients Nor Science Meant to Be Part of P2P

The documents I am releasing today at this link relate to the P2P working group. I published some of them previously in my P2P FOIA Documents, Part 2: “We also recently had a FOIA request on CFS.” But to I thought t would be helpful to group documents together topically.

My health has deteriorated dramatically. Litigation with recalcitrant, obdurate and entirely unreasonable defendants will do that when one has a disease that is significantly worsened by cognitive or physical exertion, a fact the defendants, HHS and NIH, are aware of. In the future, I might have to rely more heavily on the help of others, but rest assured, I will not be bullied into giving up. Although I am not able to comment as extensively as I would like, here are a few thoughts on today’s documents:

  • The working group planning meeting, which took place on January 6-7, 2014 and was chaired by Susan Maier, cost tens of thousands of dollars. Around $15,000 was approved for this meeting. The partial actual cost of the meeting was specified at over $20,000 with a number of expenses not yet submitted (page 1). That is at least 30% over the approved cost.
  • The members of the working group are listed below. Of particular note is the fact that the first four individuals listed (most of the non-Feds) will also be speakers at the December P2P workshop. This is noteworthy because the workshop speakers were designated by the working group, so four of them basically appointed themselves as speakers; a convenient lack of checks and balances and a self-perpetuating revolving door:

Non-Feds:

Nancy Klimas

Leonard Jason

Suzanne Vernon

Robert Miller*

Peter Rowe

Mady Hornig

Carmen Green (chair of the workshop)

Feds:

Susan Maier

Jody Engel

Deborah Langer

Elizabeth Nelson

Wilma Cross Peterman

Katherine Jung

Janet Maynard

Eun-Chung Park

Leorey Saligan

Mariela Shirley

Paris Watson

Jessica Wu

*Please note that the patient representative was chosen after a “cancelation in the ‘advocacy’ category (page 160). We do not know who NIH’s first choice for patient advocate was.

  • It is quite clear by now that HHS and it’s component agencies, such as NIH, are keeping close tabs on the community’s online activities and discussions. One has to wonder how many resources go into this monitoring. This only makes sense if they are worried. Why would they be worried? It’s as if they are trying to gauge when the lid is finally going to blow off. Instead of working with the community and, in earnest, trying to effect real progress in the field, they seem in constant damage-control mode and only worried about appearances. Because once that investigative reporter picks up this story and runs with it, nobody wants to take the hit for the atrocities of the last 30 years. For example, NIH flagged a discussion on MECFS Forums (page 7). Mariela Shirley expressed feigned and mind-boggling surprise about both predictable and justified criticism by the community of the P2P shortly after the working group meeting (page 242):

Please note that even prior to when the P2P working group planning meeting ended …, the Blogosphere and Twitterverse showed significantly heightened activity and discussion about the ME/CFS Pathways to Prevention Program.  … [T]he advocacy community is expressing considerable criticism and concern that the P2P meeting and processes are colluded and private.”

The following was sent as part of agency-internal emails just prior to, and after, the January IOM meeting:

The meeting is open to the public and we expect that media and members of the advocacy community, including those who actively blog and report on ME/CFS, will attend. We also recently had a FOIA request on CFS.

We have not received any media inquiries yet, but wanted to let you know that coverage and/or advocacy blog posts may be forthcoming on this tops. We’ll be monitoring the webcast and Twitter chat during the meeting. [emphasis added] (page 269)

Buzzfeed ran a substantial piece on ME/CFS today that you might be interested in as well: [David Tuller’s January 2014 piece]. It mentions that NIH “only spends $5 million annually” for ME/CFS. (page 268)

  • Paris Watson, who is in charge of the P2P program at NIH, instructed the “Communications Team” (page 11) not to reply to questions from the public regarding ME/CFS in order to keep tight control over the agency’s official party line:

If *any* inquiries come in regarding ME/CFS, please forward to me and do not reply.

  • According to Suzanne Vernon of the CFIDS Association of America (“CAA”), Nancy Lee, then in charge of ME/CFS at the office of the Assistant Secretary of Health and Human Services and Designated Federal Officer of CFSAC, shared with the CAA “privately” information about the definition efforts (page 20). How many advocates who are not cheerleading and covering for HHS and are, in fact, critical of the government’s actions had the privilege of obtaining secret information from HHS relating to the redefinition programs? More importantly, did the CAA use this information to throw its alleged weight behind fighting these unscientific redefinition efforts, IOM and P2P? No. Instead, the CAA has been playing patty cake with HHS being an all too willing supporter of the government against the clear interest of the community and its stated wishes.
  • Why did NIH assign extreme urgency to the P2P effort? Per Susan Maier (page 25):

As you know, NH leadership would like us to move as quickly as possible on this activity.

  • The documents show a repugnant amount of cynical condescension and disdain towards the patient community. There is no real interest in a meaningful dialogue with the patient community. Rather, the let-them-eat-cake attitude is ever-present. Some examples:

I know you will learn to regret your decision [to be part of the working group].–Susan Maier to (page 41)

I can be a little cautious when it comes to this community.–Susan Maier (page 145)

Lovely. At least no question about IOM.–Mariela Shirley (page 168)

Given the nature of the advocacy groups for ME/CFS, is it reasonable to include more than the normal number of public members?–Susan Maier (page 192)

“… I don’t think members of the public of advocacy groups are appropriate. However, it is appropriate to have a ‘patient perspective’ open the workshop. That would be a nice nod to the advocates (and may quiet the inevitable ‘where were the advocates?’ ‘why weren’t patients included as speakers”).–Paris Watson (page 191)

Fasten your seat belts and return your tray table to the upright position because it’s going to be a bumpy ride :)–Susan Maier (The smiley face is part of the quote.) (page 240)

Consider that those are only quotes from the parts that they let us see, not from the heavily redacted parts or parts they never produced in the first place or that were “misplaced.”

  • Susan Maier claimed that she was collecting the names of volunteers who would like to help with the workshop (page 48). It’s funny how this call for volunteers never became known in the patient community. Let’s be clear: There was no call for patient volunteers for the workshop. My saying this is not a case of sour grapes. I would not expect to be tapped nor would I ever consider being part of this charade. Having a patient advocate be part of the process is no more than a fig leaf. Let’s not forget that Paris Watson, the person in charge of the P2P, did not want ANY patients to partake. Participating patients were never meant to be taken seriously. They were just meant to silence any potential criticism.  (page 191):

“… I don’t think members of the public of advocacy groups are appropriate. However, it is appropriate to have a ‘patient perspective’ open the workshop. That would be a nice node to the advocates (and may quiet the inevitable ‘where were the advocates?’ ‘why weren’t patients included as speakers”).

This is also very clear from Watson’s following statement to Susan Maier. People planning on participating in the workshop should keep that in mind.

We encourage advocates to come to our meetings and participate during the town hall discussions, but please know that we really don’t allow for long commentary. (page 189)

  • NIH is claiming that the Oregon Health and Science University is a neutral group (page 51). This is about as true as the claim that the IOM is independent from the government. Both organizations rely heavily on these types of government grants for “evidence” reviews. Of course, their reports are going to be biased. Kind of like plaintiffs and defendants parading, in front of the jury, expert witnesses who testify about their opposing opinions. The only difference here is that the patient community doesn’t get to call an expert witness, only the government.
  • As of July 2013, NIH committed about $274,000 (page 61). The actual amount is likely to be substantially higher, just as the approved estimate for just the working group planning meeting, which was drastically exceeded (see above.)
  • The draft workshop key questions included crucial issues, such as how ME and CFS differ, which did not make it into the final key questions. It was one of the working group’s tasks to finalize those key questions. According to NIH’s own rules, the key questions cannot be changed once they are finalized by the working group and published in the Federal Register. Conveniently, it seems like the questions never were published in the Federal Register. At least I could not find them and if one can’t find something in the Federal Register after performing a reasonable search, it arguably cannot be deemed published. If somebody else is able to locate them, I would love to see that publication. But more importantly, it was the working group who allowed for the key questions to be drastically altered to the point of dropping the ball on including homing in on the difference between ME and CFS. Of course this is a question that HHS is deadly afraid of because the agency has spent decades confounding the two.
  • The meaningless talking points that were sent out by NIH as a canned response to inquiries by the public about P2P were blessed by the working group (page 239).
  • The workshop, which is scheduled to be held in December, has been cut short from 3 full days to 1 1/2 days (page 97). A 1 1/2-day workshop whose panel member are not experts (!) for a disease that NIH itself considers highly controversial. Of course, the controversy has been manufactured, starting in the 1980s when the CDC pretended to investigate the Lake Tahoe outbreak. Rather than examining patients, the CDC employees who went to the Tahoe area went skiing and gambling and slapped the name “chronic fatigue syndrome” on a disease that had long been known as myalgic encephalomyelitis around the world and forced their first flawed definition on us.
  • The documents contain many redactions and that seems to be the name of the FOIA game; FOIA really is a rather toothless tool for the most part because only a very small minority of people has the skills, finances, tenacity and health to follow through on a FOIA request and the government is counting on that. In any event, some of the redactions seem more interesting and telling than others, such as the ones starting on page 146 addressing a question from Nancy Lee regarding the difference between the IOM and P2P efforts, which she seems completely unclear about as she was, “following internal and external pressure,” drafting HHS’s FAQ about the IOM contract (which, by the way, HHS never took ownership of despite public inquiries).
  • The Oregon Health and Science University (OHSU) showed its utter lack of understanding of our disease in a PowerPoint presentation (starting on page 173 (December 2013 slides) and again on page 196 (March 2014 slides, which seem to be identical to the December 2013 slides) that names “chronic and disabling fatigue” as the “hallmark” symptom. Every true expert in the field knows this to be false. The signature symptom is instead a post-exertional crash, a worsening of many symptoms after only minimal cognitive or physical exertion that is completely out of proportion to the exertion. So, OSHU is ignorant about our disease and yet in charge of developing a new research definition to be used by NIH. OSHU, in the same PowerPoint presentation, lists CBT and GET as the first treatment choices. Followed shortly thereafter by “vitamins and supplements.” Science was never meant to be part of the deal when P2P was unleashed on ME/CFS.

This is about as much as I can muster in terms of comments. Obviously, there is a lot more in those documents. (I may dive deeper into them in the future.) In the meantime, I have a few more documents to release, some of which are quite interesting. More than ever, the timing of my next post is entirely driven by my health.

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P2P FOIA Documents, Part 3—NIH Organizational Meeting: ME/CFS is a “Burden” for Patients

Here is another batch from the P2P documents NIH produced in response to my P2P FOIA request.

These are documents relating to the P2P (then called the Evidence-based Methodology Workshop) organizational meeting. The meeting took place on February 19, 2013. It lead to the ME/CFS P2P Working Group, which organized the Workshop this coming December.  This was basically the meeting to decide whether to have a meeting to decide whether to have a workshop to decide the future of ME/CFS research.

Part of the meeting material for the organizational meeting (starting on page 25) was the proposal for the Workshop. It shows a profound lack of acknowledgment of the seriousness of this disease. For example, page 1 of the proposal states:

The common aspect of the illness for most affected individuals is overwhelming fatigue or malaise ….

Newsflash: No, fatigue (or worse, malaise, “a slight or general feeling of not being healthy or happy“) is NOT the common aspect for ME/CFS. Fatigue is a symptom for many diseases from cancer to depression to iron deficiency as well as the result of many normal-life activites, such as having a demanding job, overexercising, being jet-lagged or caring for infants. The hallmark symptom for ME/CFS is a post-exertional crash—an exacerbation of the multitude of serious ME/CFS symptoms following physical or cognitive exertion—that is completely disproportionate to the exertion. No true expert in the field would argue that point. With such a completely wrong premise on the part of NIH, how could the outcome of the P2P possibly be anything but a disaster?

The proposal goes on to state that activities, such as “making meals, brushing teeth and caring for children are a burden.” (emphasis added] A burden? Seriously? Yeah, it’s really inconvenient when we have to choose between eating and brushing our teeth. How annoying! And since CDC “research” claims that our symptoms are the result of childhood abuse, is it any wonder that we really do not have much interest in our kids? Maybe the real reason I am separated from my four-year old daughter is not that the FDA refuses to approve a safe and effective drug, Ampligen, for a disease that has no approved pharmaceutical treatment; maybe it is that raising my girl is a burden for me. I guess I better add a major sarcasm alert right now. Obviously, this  sad (but not unusual) excuse for a CDC study is an abuse of the term “research.” Doesn’t mean it can’t be used against us over and over.

Stay tuned for more documents. I am categorizing them by topic (and chronologically) to help the community digest them more easily and am hoping to be able to release a substantial number of documents tomorrow.

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P2P: “Pleased to Participate?” Not. Count me out!

Here is my open protest letter to Secretary Burwell (with carbon copies to Dr. Collins and Dr. Frieden) regarding the ME/CFS P2P program. As you will note, I am not engaging substantively at all. Instead, I am protesting the process all the way. Anybody should feel free to borrow the language in this letter in whole or in part for their own letter in this ongoing protest campaign, which can be sent to:

Sylvia.Burwell@hhs.gov

cc:

Francis.Collins@nih.hhs.gov

Tomfrieden@cdc.gov

Dear Secretary Burwell,

AHRQ has asked for public comments on the draft “evidence review” report prepared for the agency as part of the NIH-driven ME/CFS Pathways to Prevention (“P2P”) program. I am one of many patients who refuse to participate in the commenting process. Count me out!

In other words, let me stress, for the avoidance of any doubt, that this open letter is in no way to be construed as participation in, or engagement with, the ME/CFS P2P program. Instead, I protest this ludicrous and dangerously unscientific process in the strongest way possible.

As an ME patient and advocate, I will not participate in this kangaroo court the outcome of which is preordained to set back ME/CFS research for decades and which is so unalterably contrived, ill-intentioned and scientifically unsound as to invite only condemnation, not participation or cooperation.

The “evidence review” report prepared for AHRQ by non-ME/CFS experts is only part of this Kafka-esque charade of a process, the ME/CFS P2P, which will conclude with a two-day “workshop” of individuals who are not experts in the field and a “jury” deliberation of those non-ME/CFS experts who will have all of 24 hours to write the final report.  You or anybody with a scientific background—or with any common sense, for that matter—cannot, in all honesty, believe that this process will result in any scientifically valid outcome. A jury model is about as incompatible with science as one can imagine. Remember Galileo Galilei and how well a jury of non-experts worked for him? Is that how HHS, NIH and AHRQ see their role: in the same vein as the Roman Catholic Church of the 17th century conducting inquisitions and witchcraft trials?

The insincere call for public comments on a rigged game is a contemptible farce. I will not—by giving substantive comments—provide HHS with the opportunity to claim that patients were heard and that their input was considered when any public comments are guaranteed to be ignored, as they were with respect to the IOM panel where comments were also feigned to be sought.

The final report produced by the non-experts will guide future NIH-funded research, which has been at a paltry $5 million a year—an inexcusably and unconscionably pitiful amount for a debilitating and complex disease such as ME/CFS, which, of course, has lead to an irremediably flawed “evidence” base. That in turn, makes the P2P process just about as unfit for this disease as one can imagine. The community is in agreement that a catastrophic result of the P2P process seems to be HHS’s intention. Otherwise, HHS would abandon it immediately before the agency causes more harm to patients by forcing them to continue fighting the P2P at tremendous cost to their health and by ensuring a disastrous outcome for patients delivered at the hands of non-experts.

For your information, I am attaching an analysis of the P2P “jury model” that I wrote after this stroke of genius was initially announced to the public during the first ME/CFS IOM meeting in January.

Sincerely,

Jeannette K. Burmeister

Patient, Patient Advocate and Attorney at Law

cc:

Dr. Francis Collins, NIH

Dr. Tom Frieden, CDC

Attachment:

P2P: “Patients to Purgatory” or the Jury Model Stood on its Head, February 7, 2014

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P2P FOIA Documents, Part 2: “We also recently had a FOIA request on CFS”

I am continuing to release documents (this time, emails only) I received from HHS in response to my P2P FOIA request.

A lot of these email exchanges will show clearly the disdain, condescension and hostility towards our community.

They also demonstrate the fact that HHS is not one bit interested in our comments or even questions. HHS blew off legitimate patient concerns by replying with canned talking points—“TPs”—and when patients asked for meaningful clarification (since their questions had not been answered), Susan Maier decided that there was “[n]o need to answer them directly.” Filing those patient emails away would suffice (page 72). So much for the theory that our input will be heard.

Quoting Anne Rancourt of NIH (page 78): “We also recently had a FOIA request on CFS.” What do you think this means? Could that be NIH speak for “Be careful what you put into writing?”

Here is today’s batch.

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P2P FOIA Documents—Part 1

Earlier in the year, I filed a FOIA request with HHS for documents relating to the ME/CFS P2P. Although I received some fairly unremarkable and some heavily redacted documents a while ago, I received the vast majority of documents, which also happen to be more interesting, only recently. In fact, those documents were sent to me within days of my winning my FOIA lawsuit relating to the IOM. Quite a coincidence, wouldn’t you say?

Once again, HHS violated FOIA by failing to make the required determination within the statutory 20 business days. In fact, they took more than 8 months! I could have brought a lawsuit based on that violation alone. I did not. However, I have now filed an administrative appeal with HHS challenging the adequacy of the document search and production.

In the meantime, I will make the documents produced to me available on my blog (as my health permits; I would have started this process sooner had my health allowed me to do so.). The two batches published today consist of the earlier-produced documents. I will publish the documents that have more meat as soon as I am able, so make sure to check back for more interesting revelations.

The first batch can be found here and contains the following documents:

Page1: Agenda for Working Group Planning Meeting

Page 3: List of Members of Working Group Planning Meeting

Page 7: Email exchange re attendance of Suzanne Vernon at Working Group Meeting

Page 10: Email to Working Group Members re Furlough

Page 11: Email exchange re Participation of Ben Barres in Working Group

Page 13: Email exchange re Participation of Ian Lipkin in Working Group

Page 15: P2P Agenda Example

Page 18: Panelist Nomination Form

Page 22: Key Questions

Page 23: Topic Refinement Content Guidance Document

Page: 31: Table comparing Fukuda, Canadian and Revised Canadian

Page 39: P2P Workshop Draft Agenda

Page 43: PowerPoint Presentation Susan Maier, NIH, on ME/CFS P2P

Page 56: PowerPoint Presentation, NIH, on P2P

Page 70: PowerPoint Presentation M.E. Beth Smith and Marian McDonach, Pacific Northwest Evidence-based Practice Center Oregon Health and Science University, Portland, on Diagnosis and Treatment of ME/CFS

Page 90: PowerPoint Presentation, Wilma Peterman Cross, ODP, for P2P Working Group meeting January 6, 2014

Page 98: PowerPoint Presentation Jody Engel, NIH, on P2P

The second batch can be found here and contains the following documents:

Page 1: FAQs about the EbMW Program for EPC Kickoff Call, April 2013

Page 8: Proposal for ME/CFS EbMW

Page 12:Email exchange with Suzanne Vernon re Patient Advocates

Page 16: Request for Task Order, Evidence-based Practice Center

Page 36: Task Order, Oregon Health & Science University

Page 49: Topic Refinement Document Part 4: Development of the Provisional KQs, PICOTS and AF Provisional Key Questions) (entirely redacted)

Page 56: Suggested Technical Expert Panel Members (entirely redacted)

Page 58: Topic Refinement Content Guidance Document Part 1: Summary of Topic Development and Development of Preliminary Scope (KQ, PICOTS and Analytic Framework) (entirely redacted)

Page 66: Evidence-based Practice Center, Project Staffing Plan (mostly redacted)

Page 68: AHRQ-OHSU contract

Page 121: Request for Task Order (basically entirely redacted)

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P2P: Don’t Buy the Hype! Protest!

The reason why I will not cooperate with, or participate or engage in, the P2P process is very simple. HHS and NIH have shown time and time again that they do not have ME patients’ interest at heart. This disturbing and indisputable fact has been confirmed again very recently in my FOIA lawsuit regarding documents relating to the IOM contract (the diagnostic equivalent of P2P), in which I won my motion for summary judgment against HHS and NIH in early September with a ruling by the court that the government violated federal law. The government, in turn, lost their motion for a summary judgment against me. HHS’s and NIH’s conduct in this matter has been dilatory, obstructionist and unlawful.

I initially filed my lawsuit pro se (meaning without engaging lawyers) because I was hoping that, when faced with a lawsuit, the government would finally comply with the law. I wanted to give them a chance to resolve the matter swiftly and without incurring any legal fees. Before filing my complaint, but sadly to no avail, I even gave them a warning that legal action was imminent, unless they complied. Even after filing my complaint, the government did not avail itself of the opportunity to moot the lawsuit (i.e., end it with a relatively small legal bill) by conducting a reasonable document search. Instead, the government filed a frivolous summary-judgment motion five months after I initiated litigation when they could have used all that time to remedy their prior FOIA violations. When faced with my opposition motion that clearly demonstrated that the government was in violation of federal law, they doubled down by filing another motion making frivolous and meritless legal arguments and misstating the law and the facts—the latter, under penalty of perjury. Even as late as in the oral-argument phase did they incorrectly cite the law, as noted by the court.

HHS and NIH have wasted the court’s time and energy and worse, they have directly caused my health to dramatically deteriorate as a result of their unreasonable conduct and stonewalling, as the case was factually extremely complex and required my close involvement in discussing strategy with my attorneys, reviewing documents, drafting and revising the motions, etc. This has predictably triggered an intense post-exertional crash, the hallmark symptom of ME. Ironically, HHS and NIH continue to boast of their commitment to our disease. It would follow that they knew about the post-exertional fall-out that their indefensible approach would have on my physical health and yet they passed on every opportunity to right their wrong. Instead, they have done everything to prolong this litigation and drive up my attorneys’ fees. Counsel for the government stated during oral arguments that he didn’t even understand the case until July of this year, six months into the litigation! Half a year! That is how seriously they take this patient population.

In short, HHS and NIH have acted like bullies vis-à-vis a disabled ME patient whose only “infraction” was to avail herself of her statutory rights. After all that litigating, the court ordered HHS and NIH to do what they should have done more than eight months ago, without a dime spent and without any additional damage to my health: to produce the requested documents. Does anybody honestly believe that the government is somehow—miraculously—going to conduct itself differently in this ludicrous and high-stakes jury-model P2P project when they don’t even take a very simple and straightforward FOIA request seriously and instead fight it tooth and nail contrary to explicit instructions by the US Attorney General for clear-cut cases like mine? Please see “P2P: ‘Patients to Purgatory’ or the Jury Model Stood on its Head” for an explanation of why the jury-model analogy of NIH is preposterous.

I urge patients and other stakeholders to voice their unambiguous opposition to the P2P in strong, but professional, terms. Opposing this effort means making our voices heard; quite obviously, it is the opposite of silence. Getting our opposition on the record is crucial because the government will try to claim that they had the support of the patient community for P2P when that is clearly not the case, as even most of those who suggest that patients should cooperate with the process are against the P2P in principle. Engaging the government allows them to claim that they took the community’s concerns into account when they have no intention of doing so. Their outreach to the patient community, the comment period, is a mirage.

The distinction between opposing/protesting and participating/cooperating/engaging is subtle, but very important. To clarify:

Do not participate or cooperate by making suggestions on how the P2P should be conducted or which areas it should focus on or by engaging regarding the seriousness of the disease, etc. Basically, do not make any substantive comments, in writing or in person at the workshop, because that will, without a doubt, be entirely ignored, as has been the case with the IOM and will allow the government to pretend that our concerns have been heard and will be reflected in the P2P outcome. Remember the changes that were made to the IOM panel in response to patients’ concerns about various suggested panel members’ conflict of interests? No? I don’t either. The make-up of the committee was not changed at all despite a few advocates researching the background of the proposed panel members and finding some troubling facts. The feedback of those advocates was entirely ignored. If the government wanted our input, they would have designed the whole process completely differently instead of merely having one token, hand-picked patient advocate at the P2P workshop purporting to speak for the entire community. Giving our input means legitimizing the farce. Don’t fall for it.

Opposing/protesting, on the other hand, is stating one’s unequivocal disapproval of this redundant, unscientific and ludicrous effort without making any substantive suggestions whatsoever. This effort is redundant because we already have a research definition that has been adopted by our experts, the Canadian Consensus Criteria. P2P is unscientific because it precludes anybody with ME/CFS expertise from being a member of the P2P panel. And it is ludicrous because the utilization of the jury-model approach in this context is, frankly, beyond comprehension. Therefore, I will send a letter protesting the entire effort in no uncertain terms, but without engaging substantively.

There is no doubt in my mind that P2P will harm patients greatly and I will have no part in that by being seduced into thinking that my engaging will result in any meaningful effect on the process.

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US District Court: HHS/NIH Violated Federal Law in Response to FOIA Request for IOM Documents

I am pleased to give an update on my FOIA lawsuit:

Yesterday, the United States District Court for the Northern District of California ruled that HHS and NIH (government) violated the Freedom of Information Act (FOIA) when they improperly withheld documents from me in response to my FOIA request regarding HHS’s contract with the Institute of Medicine (IOM) for the study of diagnostic criteria for ME/CFS.

Accordingly, the Court granted my motion for summary judgment and ordered the government “to produce, within 60 days, all documents responsive to [my] request that are not covered by any exemption to FOIA’s disclosure requirements.” [emphasis added] The Court also denied the government’s motion for summary judgment asking for a dismissal of my lawsuit.

I believe that holding HHS and NIH legally responsible for their violation of federal law is a tremendous victory for our patient population. However, since this litigation is ongoing, I will not, at this time, be able to comment further or answer any questions beyond the following details and quotes from the Court’s ruling. Although there will hopefully be more good news before the case is over.

In January of this year, I sued the government under FOIA for failure to respond to my FOIA request for documents regarding the HHS-IOM contract. I have been represented in this legal action by the global law firm of Baker & McKenzie LLP. Only after my filing of the lawsuit (and after the statutory time period for their response had lapsed) did the government produce a meager amount of documents despite the fact that my FOIA request was very broad.

It was apparent that the government’s search for responsive documents was woefully inadequate, as obviously existing documents covered by my request that would have been easily available to the government and that a reasonable document search would have uncovered were not provided. The Court agreed and held that the search was the result of “obviously an unreasonably narrow interpretation of Burmeister’s request.” [emphasis added] The Court further states, “Indeed, [the HHS FOIA specialist] explains in her supplemental declaration that a broader search (the one the government should have conducted given the actual language of Burmeister’s request)is a completely different type of search and presumably would have resulted in a much larger production.’” [emphasis added]

The Court goes on to address the unreasonably narrow interpretation of my FOIA request by the government in more detail:

“And [the HHS FOIA specialist] is correct about that. For example, without listing every document that could be responsive to Burmeister’s actual request, it is obvious that all records relating to the original effort by HHS to enter into a sole-source contract with the Institute of Medicine, and documents relating to the subsequent decision to change course and proceed with a task order in response to expressions of concern by members of the public about the manner in which HHS was proceeding, would be responsive. Such records exist, but the government did not provide them to Burmeister.

“Because [the HHS FOIA specialist’s] supplemental declaration demonstrates that the government adopted an unreasonably narrow interpretation of Burmeister’s request, because [the HHS FOIA specialist] concedes she would have performed a much broader search had she interpreted the request correctly, and because that search would have uncovered additional records responsive to the request, the government has ‘improperly withheld agency records’ in violation of FOIA.” [emphasis added]

The Court then addresses the government’s meritless claim that my lawsuit is moot due to the government’s production of some documents after the complaint was filed despite the fact that the document search was inadequate:

“To avoid this conclusion, the government argues that Burmeister’s lawsuit should be dismissed as moot. Specifically, the government contends that even if Burmeister had the right to file her lawsuit because HHS failed to respond to her request within the time period required by FOIA, its subsequent production to Burmeister moots the lawsuit, even if the production was deficient. At the hearing on this motion, counsel for the government insisted that the case law compels this result – he argued that even if the production was deficient, the case law required that the lawsuit be dismissed as moot and that Burmeister be left to submit a response to the government’s production explaining how she believed it was deficient, so that the government would have a chance to remedy the deficiencies. However, the case law says exactly the opposite of what counsel for the government represented at the hearing,” namely, “To moot a FOIA claim, however, the agency’s production must give the plaintiff everything to which he is entitled. [emphasis added] Otherwise, there remains some ‘effective relief’ that can be provided the plaintiff, and the case is not moot.”

According to the Court, the government’s argument that I did not exhaust my administrative remedies and, thus, my lawsuit should be dismissed also fails:

“The government also contends Burmeister’s lawsuit should be dismissed for failure to exhaust her administrative remedies with respect to her claim that the agency’s search was inadequate. Specifically, the government argues that it responded to Burmeister’s request on January 7, two days before Burmeister sued, and that Burmeister should have objected to HHS about the adequacy of the response before filing the lawsuit. But the government’s response was not postmarked until January 8, and Burmeister credibly asserts she did not receive it until several days after she filed her complaint. Nor, in any event, was the government’s response a final or complete one – in other words, it was not a real response. The real response (which was, as discussed above, inadequate) came on February 3. Because the government failed to timely respond to Burmeister’s records request, and because Burmeister did not receive a final decision from the government until after she filed this lawsuit, her case is properly before the Court.” [emphasis added]

The 60-day period the Court allowed for the government to produce all documents responsive to my request (and not exempt under FOIA from production) runs on November 3. Let’s hope that the Court’s ruling will be a wake-up call for the government and a reminder that it is not above the law.

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My June 2014 CFSAC Testimony: Tribute to Eileen Holderman

Jeannette 2014-06-16First, I ‘d like to congratulate the newly appointed committee members. The patient community is particularly excited about the addition of Dr. Jose Montoya, a true ME/CFS expert with crucial clinical and research experience in our disease, something HHS committees desperately need a lot more of.

I also would like to thank the committee members who recently rotated off CFSAC. I want to dedicate my comments to advocate extraordinaire, Eileen Holderman, the outgoing patient advocate. Eileen has not asked me to make the following comments nor is she aware of them. She has never sought the spotlight for her countless contributions, having turned down many offers for interviews and feature stories. She is not in this for the glory. In fact, few are aware of her many efforts and she rarely gets credit for her hard-hitting and strategically smart advocacy.

Despite being quite sick with ME/CFS, Eileen is a force of nature. Her experience, intelligence, dedication, professionalism, hard work, strength of character and strong relationships with researchers, clinicians and advocates make her easily the most effective advocate of our time.

I have been in awe of, and inspired by, Eileen’s unshakable and unparalleled integrity, especially in the face of public and behind-the-scenes hostility and palpable lack of respect from HHS. When she went public last year with intimidation attempts by HHS, she was brushed off without an adequate investigation or even as much as an official response to her from Dr. Koh, Assistant Secretary of Health, let alone an apology or assurances of refraining from further intimidation on the part of HHS. Eileen cannot be intimidated nor can she be co-opted and that is crucial for effective advocacy that does not sacrifice the good of the community for personal gain. Eileen is not interested in financial favors, seats at tables of rigged games, rubbing elbows with the perceived powerful, prominence or anything else that is so often wrong with advocacy.

Three minutes are not nearly enough to go into any meaningful detail. But remember, Eileen called out HHS, on the record, for hijacking CFSAC’s recommendation and hiring the IOM. She has been unflinching in her opposition to the IOM effort. Eileen is the one who has continually reminded this committee that its shameful practice of calling our disease “chronic fatigue” is unacceptable and unscientific, sadly to no avail for the most part. We have to thank Eileen for the inclusion of the Canadian Consensus Criteria in this committee’s recommendations at the last meeting. She made her motions so swiftly that HHS was unable to mount enough opposition. Ironically, it probably would have been easier to shut down Eileens’ effort if the meeting had been in person instead of a teleconference with slides.

I look forward to seeing a lot more from Eileen in the future. This community is blessed to have her and owes a tremendous debt of gratitude to Eileen Holderman! Thank you, Eileen!

Posted in ME/CFS In the News | Tagged , , , , , , , , | 11 Comments

Let it Go, Dr. Koh: The Truth Never Bothered You Anyway

After watching “Frozen” for the umpteenth time with our daughter, this line would not leave my head:

Let it Go, Dr. Koh: The Truth Never Bothered You Anyway

Of course, this is pure satire having a little fun at the government’s expense. So, here we go:

 

The cover-up’s on your desk tonight

No patient care to be seen

A kingdom of obfuscation

And it looks like you’re the king

 

IOM is howling like this swirling storm inside

Couldn’t keep it in, heaven knows you tried

 

Don’t let them in, don’t let them see

Hide the truth with your buddy Nancy Lee

Conceal, don’t feel, don’t let them know

Well, now we know

 

Let it go, Dr. Koh

Don’t hold it back anymore

Let it go, Dr. Koh

Turn away and slam the door

 

You don’t care

What the experts say

Let IOM rage on

The truth never bothered you anyway

 

It’s funny how some bulls**t

Makes IOM stand tall

And the needs of all the patients

Don’t get to you at all

 

It’s time to see what you can do

To crush the patients and experts, too

No right, no wrong, no rules for thee

You’re free

 

Let it go, Dr. Koh

You are one with the devil on the sly

Let it go, Dr. Koh

You never seem to cry

 

Here you stand

And here you’ll stay

Let IOM rage on

 

Your power flurries through the air into the ground

Our lives are spiraling in pathogens all around

And one thought crystallizes like an icy blast

We’re never going back

Fukuda’s in the past

 

Let it go, Dr. Koh

And we’ll rise like the break of dawn

Let it go, Dr. Koh

Your perfect ruse is gone

 

Here you stand

In the light of day

Let IOM rage on

The truth never bothered you anyway

Posted in Uncategorized | Tagged , | 17 Comments

OIG Fails to Investigate IOM Conflict of Interest & Tells ME/CFS Patients to Buzz Off

And once again, I received a perfunctory reply from the Office of the Inspector General (OIG) basically telling the entire ME/CFS community to buzz off (my reply is below). Am I surprised? Absolutely not. We’ve been mistreated and disrespected by HHS for so long. Why would they change it up now?! Am I outraged? You bet. As an American citizen and a taxpayer, I have a right to request that the OIG investigate an obvious organizational conflict of interest of the Institute of Medicine. And yet, the OIG is telling me that they can’t be bothered. The arrogance and display of indifference and/or incompetence (who knows) of the reply is astounding, although not unexpected. The message is that HHS is above the law and that we just have to suck it up. They are basically saying, “Watch us break the law! What are you going to do about it?!”

The OIG had no problem finding a conflict of interest with respect to an IOM committee member participating in a study of the adverse effects of the pertussis vaccine merely due do his comments on the topic given in a deposition (letter of Inspector General to Assistant Secretary of Health dated January 3, 1992). Is it not patently obvious that—if the prior position of an IOM committee member on a topic under study by the IOM is a conflict of interest—the prior highly publicized position of the entire IOM as an institution (on several occasions) on a key issue to be addressed under a new contract would, of necessity, present an organizational conflict of interest? Of course it is to any competent lawyer! Draw your own conclusions about whether the office of the OIG is covering up for HHS or if the lawyers working for the OIG are doing so because they are woefully incompetent.

(My prior letters to the OIG: November 11, 2013, November 16, 2013, January 7, 2014, April 4, 2014)

 

Jeannette K. Burmeister

 

May 27, 2014

 

By U.S. Mail

By Facsimile

By Email

 

Abigail Cummings, Chief

Advice Branch

U.S. Department of Health and Human Services

Office of Inspector General

Attention: OIG Hotline Operations

P.O. Box 23849

Washington D.C. 20026

 

Re: Organizational Conflict of Interest of the IOM in ME/CFS Study, Fourth Request

 

Dear Ms. Cummings:

I received your reply dated May 14, 2014 to my letters of January 7, 2014 and April 4, 2014, with regard to the task order under the contract between the Department of Health and Human Services (“HHS”) and the National Academies of Sciences’ (“NAS”) Institute of Medicine (“IOM”) to conduct a study and produce a consensus report with recommendations for new diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome (“ME/CFS”).

I note, as an initial matter, that your May 14, 2014 letter specifically acknowledges that your office has not undertaken, nor will it, an investigation of the propriety of the aforementioned IOM contract. In other words, your office has admittedly rejected doing any investigation of the alleged organizational conflict of interest (“OCI”) I have asserted in my prior correspondence dating back to November 11, 2013.

Your May 14, 2014 letter cites, as one reason for not responding to my January 7, 2014 letter, the fact that I mentioned that legal issues were being evaluated by patients and lawsuits were being considered with respect to the IOM contract.

This reason is spurious. The fact that lawsuits are being considered is not an excuse for the OIG to abrogate its duty to investigate a potential OCI with respect to a major HHS contract. Moreover, I fail to see how a substantive response to support the conclusion that no OCI exists with respect to the IOM contract would in any way prejudice HHS in defending any lawsuit alleging an OCI.

Despite citing the reasons why your office didn’t respond previously, you go on to provide your conclusions that:

(1)  The IOM Contract does not present an OCI.

(2)  Even if it did, HHS could waive it.

(3)  OIG has no authority to compel HHS to terminate an award of a contract.

(4)  There are statutory requirements to safeguard against the outcome of IOM reviews.

Addressing point (3) above, I am requesting that the OIG investigate and determine whether an OCI exists and, if so, whether it was properly waived by the Secretary of HHS or his or her designee, not to terminate the contract on its own initiative.

Addressing point (4) above, I note that the requirements of Section 15 of the Federal Advisory Committee Act address conflicts of individual members of an IOM committee and procedures regarding notices of IOM meetings and reports and procedures relating thereto, and do not address at all an OCI of the IOM as an institution. I find it beyond frustrating and insulting that you continue to treat my request as though it relates to conflicts of interests of individual IOM Committee members. Maybe you really do not understand the difference between a conflict of interest of an individual panel member and an OCI and in that case, I would be happy to explain it in even simpler terms than I have ad nauseam already. But it is crucial that you in fact have an understanding of the issue I keep raising and so far, I have no indication that you do.

Addressing points (1) and (2), I note the following: You state, still without any explanation or elaboration whatsoever, that there is no OCI and continue to provide explanations of why individual conflicts of interest have been vetted with respect to this contract. In law school, your reply would receive a failing grade for lack of any analysis. I have provided a thorough analysis of my conclusion that an OCI exists here due to the impaired objectivity of the IOM regarding a study of ME/CFS, given its previous conclusions regarding this disease in prior contracts. Frankly, I find it remarkable, distressing and, most of all, disrespectful to the concerned patient community that you choose not even to address this issue substantively despite my repeated requests.

You assert that, even if there is an OCI, the agency may waive it. That is in no way an excuse for evading a determination whether an OCI exists. Once that is determined, then a waiver may be requested in writing by the contractor (IOM) and this may be approved only by the agency head or his or her designee. It is simply inappropriate for your office to avoid its duties in determining whether an OCI exists by assuming a waiver would be granted. To do so would make the waiver requirement irrelevant. I ask you to confirm whether a waiver was requested here and, if so, whether and by whom it was granted. I also request a copy of the written waiver request (as required by 48 CFR §9.503) and its approval by the head of the agency or his or her designee.

If there has been no waiver request, then I once more—for the fourth time— reiterate my request for a substantive, non-conclusory response from the OIG as to the basis for your conclusion that no OCI exists here.

In light of the many documented failures and shortcomings of federal agencies with regard to conflicts of interest, including specifically HHS, and with respect to ME/CFS in particular, I would hope that the OIG would take this issue more seriously than it sadly has demonstrated thus far.

If in fact the OIG finds, after a thorough and substantive evaluation of the situation, that no OCI exists, then it can and should provide that conclusion and analysis to me and other patients highly interested in, affected by, this contract.

Sincerely,

Jeannette K. Burmeister

Attorney at Law

Cc:

Barack Obama, President of the United States of America

Daniel R. Levinson, Inspector General, U.S. Department of Health and Human Services

Senator Harry Reid, Majority Leader in the U.S. Senate

Tom Coburn, M.D., Ranking Member, Senate Committee on Homeland Security and Governmental Affairs

Senator Tom Harkin, Chairman, Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Senator Jerry Moran, Ranking Member, Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Jack Kingston, Chairman, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Rosa DeLauro, Ranking Member, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Lucille Roybal-Allard, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Barbara Lee, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Mike Honda, California, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Adam Trzeciak, Inspector General, U.S. Government Accountability Office

Rush Holt, U.S. House of Representatives, Committee on Higher Education and Workforce Training, Subcommittee on Health, Employment, Labor and Pensions

Dr. Harvey Fineberg, President, Institute of Medicine

Dr. Howard Koh, Assistant Secretary for Health, Department of Health and Human Services

Dr. Wanda Jones, Principal Deputy Assistant Secretary for Health, Department of Health and Human Services

Ms. Jennifer Cannistra, Executive Secretary, Department of Health and Human Services

Mr. Oliver Potts, Deputy Executive Secretary, Department of Health and Human Services

Dr. Richard Kronick, Director, Agency for Healthcare Research and Quality

Dr. Thomas Frieden, Director, Centers for Disease Control and Prevention

Ms. Marilyn Tavenner, Administrator, Centers for Medicare and Medicaid Services

Dr. Margaret Hamburg, Commissioner, U.S. Food and Drug Administration

Dr. Mary Wakefield, Administrator, Health Resources and Services Administration

Dr. Francis Collins, Director, National Institutes of Health

Dr. James M. Anderson, Deputy Director, National Institutes of Health

Dr. Harold Varmus, Director of the National Cancer Institute

Dr. Anthony Fauci , Director of the National Institute for Allergy and Infectious Diseases

Ms. Carolyn W. Colvin, Commissioner, Social Security Administration

Kathleen Sebelius, Secretary of Health and Human Services

Posted in Uncategorized | Tagged , , , , , , , , , , , , | 11 Comments

P2P Review Protocol: Still No Transparency

Today, what seems to be the Systematic Review Protocol for the Pathways to Prevention (“P2P”) was published online.

The secrecy continues: The publication does not include the names of the technical experts and NIH refused to divulge those names in response to my FOIA request. To my knowledge, NIH also has not released the names of the members of the NIH Working Group.

There is nothing in this document that relieves my concerns about the “jury-model” approach to this whole P2P process.

Hat tip to Jay Spero for the find.

Posted in Advocacy | Tagged , , , , , , , , | 9 Comments

Thunderclap to Oppose the IOM, Support the CCC: Let Our Voices be Heard Loud and Clear

The next IOM meeting will be held on May 5th and 6th.  A whooping one fourth of the meeting is open to the public’s listening in. No public participation is allowed, except for comments by a few, hand select people. But we can still make our opposition to the IOM “study” and our support for the CCC heard loud and clear during that meeting by participating in the Thunderclap campaign that will run on the morning of the first day of the next IOM meeting. It’s very easy. Below are step-by-step instructions.

What is Thunderclap?

Thunderclap is a crowd-speaking platform that amplifies messages by allowing large groups of people to share a single message together at the same time by pledging to Twitter and/or Facebook and/or Tumblr a message that will be broadcast at the exact same time in order to achieve maximum effect. It’s like an online flash mob. By using Thunderclap, our reach on social media will be far broader than it would be if we were simply posting on Twitter, Facebook and Tumblr without Thunderclap.

Thanks to Wendy Boutilier and Sally KeelaToo Burch for the graphic and to Fred Smith for allowing us to use her YouTube video. And thanks to everybody who has already participated and is promoting this effort. It’s very much appreciated.

Instructions

Go to the Thunderclap page here https://www.thunderclap.it/projects/10666-stop-the-iom-adopt-the-ccc

Facebook

Click on “Support with Facebook.” If you are signed into Facebook, click on “Add my support.” (If you are not signed into Facebook, Thunderclap will ask you to do so as one of the required steps.) If you wish, you can personalize the message that will appear on your FB wall on May 5th under “Make it your own! Add a custom message” or you can just leave the message unedited, which is a good option for folks with cognitive impairment or healthy friends and relatives with busy lives or are not totally familiar with the issue.

The next window that opens requires you to agree to the Thunderclap app. Simply click “okay” if you are in fact ok with that.

If you want to get updates about this Thunderclap campaign (from me), you can then enter your email address. That will allow me to let you know of milestones we achieved. This is entirely optional. If you do not wish to receive updates, just click on “No thanks.” If you do want to sign up for updates about this particular Thunderclap campaign, I suggest you opt out of “Keep me updated on other news and developments from Thunderclap” simply by unchecking that box in order to keep your inbox clutter down.

The last step is to share with your Facebook friends that you supported the Thunderclap campaign. Promoting the campaign that way goes a long way in gaining additional supporters. Again, you can simply click on “Share” or customize your message. (This is a different message than the one that will go out on May 5th, which you can find towards the end of this post. The message in this step just lets people know about the upcoming Thunderclap on May 5th.)

If that was successful, the blue Facebook button will turn grey indicating that you no longer have the option of supporting this campaign using FB. This way, Thunderclap prevents people from cheating by supporting the cause more than once using the same platform, in this case Facebook.

Some people have reported that their support “didn’t take.” So, it’s a good idea–after refreshing the page–to scroll down on the Thunderclap page and check under “Recent Supporters.” If your name does not appear there, something went wrong and you should try again. Your name will get pushed down as others support the campaign, so it’s best to check right away after you completed the above steps.

Twitter

If you have a Twitter account, please support the Thunderclap using Twitter AS WELL, i.e., even if you already supported via Facebook. Simply click on the Twitter button on the Thunderclap page under “Support With.” You can either just click on “Add my support” and leave the tweet that will go our on May 5th as is or customize it and then click on “Add my support.”

You then have to authorize the Thunderclap app.

Then “spread the word” on Twitter that you are participating in this Thunderclap by clicking on the “Tweet” button. You can customize the message that goes out to your followers to let them know about your participation or leave the tweet as is. Click “tweet” again in the window that opens and you are done. (This is a different message than the one that will go out on May 5th, which you can find towards the end of this post. The message in this step just lets people know about the upcoming Thunderclap on May 5th.)

And once more, you get the choice of receiving updates from the campaign and Thunderclap. Both are optional and I would recommend you un-check the button for Thunderclap developments. Please see above under “Facebook” for more info.

Then refresh the page and if all went well, the Twitter button will now be grey. You can confirm that your Twitter support “took” by checking if your name appears under “Recent Supporters.”

Note

If you used both Facebook and Twitter, your name should appear under “Recent Supporters” twice. Most people use a different profile picture for Facebook than for Twitter (avatar). This is a good way to tell which method of support might not have worked if there was a problem and try again.

Tumblr

I do not have a Tumblr account, so I can’t walk you through the steps for that. But I imagine it is similarly easy as Facebook and Twitter.

Keep Sharing

Please keep sharing this Thunderclap campaign between now and May 5th. If everybody tries to get at least three additional people to sign up and those people, in turn, try to get at least 3 people involved, we can make a real splash during the IOM meeting. Send emails to friends or family members that you know are supportive. Share on Facebook and Twitter frequently. This is a very easy way for healthy folks to help our cause. The Thunderclap website explains the reason for our opposition to the IOM “study” and our support of the CCC.

What happens on May 5th?

At 9am on May 5th, the morning of the first day of the next IOM meeting, the following message will be shared on your Facebook wall and/or your Twitter feed:

“Stop IOM non-experts from defining #MECFS! Adopt CCC per experts! Stop org COI. #StopIOM #AdoptCCC #HHS http://thndr.it/1i99XF3

Question?

Please do not hesitate to contact me with questions you might have regarding this campaign or if you run into trouble with the Thunderclap website. It’s easier than it looks, but brain fog can play tricks on us sometimes. I am very happy to help.

Posted in Uncategorized | Tagged , , , , | 30 Comments

Now You See It, Now You Don’t: HHS Covers Up Flawed IOM Contracting Procedure

In January of this year, I questioned the compliance of the IOM task order with the requirements of the NIH/NAS umbrella contract under which the task order was issued. I had found information on a website of the Office of Science Policy and Analysis—which I linked to in my blog post about the issue—according to which any task order to be awarded under that contract must “[r]esolve all questions about the scope … of the activity.” Yet, one of the first IOM meeting’s agenda items was to “clarify the scope of the charge.” So, it would seem that at least one of the requirements of the umbrella contract wasn’t met with respect to the IOM task order, which would explain the secrecy and manufactured urgency regarding the contracting process.

Imagine my surprise when I clicked on that link [http://ospa.od.nih.gov/nac.html] today and got automatically redirected to a completely unrelated site of the Office of Science Management and Reporting [http://osp.od.nih.gov/office-science-management-and-reporting] that contained no information about the umbrella contract. That information completely disappeared. But guess what! I have a scanned print-out: Office of Science Policy and Analysis_Umbrella_K_RequirementsHere is a screen shot of what you see when you click on the original link now:

Office_Science_Management_Reporting

Is anybody still denying that something fishy is going on with this IOM contract? And is anybody still arguing that there is any way that this over-the-top secrecy is innocent? Why would HHS make the information disappear from the Internet after I pointed out the contracting-process issue? What else are they hiding?

One thing that comes to mind is that the request for proposal, which is also clearly required under the umbrella contract (see requirements in the first image above), seems to have never been prepared. Why else would the statement of work be titled “Statement of Work/Request for Proposal.” Logically and from a proper contract-drafting perspective, the request for proposal has to come before the statement of work by necessity. It is ludicrous to have both sets of terms be in the the same legal document.

Posted in Uncategorized | Tagged , , , , , , , , , , | 19 Comments

IOM-OCI-OIG … OMG!

The organizational conflict of interest (OCI) of the Institute of Medicine (IOM) in the ME/CFS case-definition study is as obvious as it gets. The IOM, as an institution, has given its opinion about the diagnostic criteria for ME/CFS various times in the past in its Gulf War Illness reports. The IOM’s objectivity is therefore impaired, the definition of an OCI. Every lawyer with any analytical skills can see that.

However, the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) whose mission it is “to protect the integrity of [HHS] programs” continues to provide cover for the IOM by stonewalling and simply replying in an evasive manner and dodging the problem altogether, at the taxpayer bill of $1 million, despite my raising it three times in the past. Please see here, here and here for my prior letters.

Here is my latest attempt to at least get some kind of substantive reply from the OIG. Several congressional offices have started to show real interest in the issue. Stay tuned.

April 4, 2014

Re: Organizational Conflict of Interest of the IOM in ME/CFS Study, Second Follow-up Request

Dear Ms. Cummings:

I note your failure to reply to my letter of January 7, 2014 (attached), almost three months ago, specifically requesting that your office address the organizational conflict of interest (“OCI”) of the Institute of Medicine (“IOM”) with respect to the IOM study for diagnostic criteria for ME/CFS (“ME/CFS IOM Study”) in a substantive way, as opposed to providing a mere conclusionary statement without giving any valid explanation of how you arrived at your conclusion—as you have done in your letter of December 30, 2013—taking into account the analysis of the OCI that I am providing to your office for the third time now. You prior letter was entirely non-responsive to that issue and, in fact, dodged it altogether.

I want to assure you again that this issue is of the utmost importance, as the ME/CFS IOM Study presents the very real potential for disastrous consequences for the ME/CFS patient community, as I described again in my letter of January 7, 2014. Members of Congress and the media have been, and continue to be, made aware of this crucial issue and your failure to respond.

On page 2 of my initial letter to your office of November 11, 2013 (attached), I gave you several examples of how the IOM addressed the case definition, symptoms and treatment modalities for ME/CFS in its 2013 Gulf War Illness (“GWI”) report.[1] While the IOM ME/CFS Study’s scope does not include treatment, my letter explained how treatment recommendations inform the case definition for ME/CFS and how the two issues are inseparably intertwined due to the complex nature and the particulars of the disease.

I want to raise for your further consideration, in evaluating the IOM OCI with respect to the ME/CFS IOM Study, the issuance of yet another IOM report on GWI since my last letter to you, this one reviewing the case definition, just like the currently ongoing ME/CFS IOM Study. On March 12, 2014, the IOM released its report “Chronic Multisyptom Illness in Gulf War Veterans: Case Definitions Re-examined” (“IOM 2014 Gulf War Illness Report”).[2] This report—the final content of which, according to the report itself, “rests entirely with the author committee and the institution [IOM],” as have the previous IOM GWI reports—again contains specific findings with respect to diagnostic criteria for ME/CFS, the very topic the IOM is charged with under the ME/CFS IOM Study. You will find the relevant discussion mostly on pages 26-27 of the IOM 2014 Gulf War Illness Report, which, among other statements, asserts the following:

  • There are no “confirmatory physical signs or laboratory findings” for ME/CFS.
  • There is “no accurate diagnostic test or proven treatment” for ME/CFS. (The latter point is of particular interest, as there are a number of effective treatments for the disease. Any assertion to the contrary constitutes bootstrapping of the failure of the FDA’s approval of such treatments. The FDA’s failure to act and approve available treatments is detrimental to the patient community enough without making it part of the official case definition for ME/CFS and, thus, giving insurance companies an excuse to deny coverage for effective treatments.)
  • “There is no validated diagnostic test” for ME/CFS.
  • ME/CFS should be considered both a mental and physical disorder.

The foregoing conclusions are part of what the ME/CFS IOM committee is currently tasked with determining under the ME/CFS IOM Study. And yet, the IOM, as an institution (see above), has already reached its conclusions regarding ME/CFS in the IOM 2014 Gulf War Illness Report. Because the ME/CFS IOM committee members will have easy access to the IOM 2014 Gulf War Illness Report and its findings on the case definitions for ME/CFS, this situation clearly presents a case of impaired objectivity with respect to the current ME/CFS IOM Study. The IOM cannot avoid assessing its conclusions under the prior contract, the very embodiment of an OCI manifested as impaired objectivity.

The proper case definition of ME/CFS is not only the principal charge under the ME/CFS IOM Study, it is a highly contentious issue that is at the heart of the future diagnosis and treatment of a million ME/CFS sufferers.

It is entirely unrealistic to expect the IOM to retract or modify its prior findings on ME/CFS. To do so would undermine the credibility of the IOM with respect to the highly contentious and publicized series of reports on Gulf War Illness. Here is another way of putting it. Don’t you think specific findings regarding ME/CFS in an IOM report issued less than a year before the scheduled release of the ME/CFS IOM Study, which findings played an integral part in the IOM reaching its conclusions regarding the case definition for GWI, would create a lack of objectivity in evaluating these same issues (case definition for ME/CFS) in the current $1 million ME/CFS IOM Study? Any legal analysis reaching a different conclusion is not defensible, plain and simple.

Certainly you can recognize this situation as reflecting impaired objectivity of the IOM. Isn’t it much better to halt this study in its early stages to avoid the criticisms and challenges or worse, which will, no doubt, be raised should a final report be issued? If the current ME/CFS IOM Study follows the findings in the IOM 2014 Gulf War Report with respect to ME/CFS, it and HHS will be held to public ridicule and likely legal challenge based in large part on the OCI. This is particularly the case given the fact that the IOM basically admitted its own lack of expertise when it comes to developing diagnostic criteria for complex diseases—no surprise after the admission of the committee chair for the IOM 2014 Gulf War Illness Report, Dr. Kenneth Shine[3] that the IOM does not have any experience with this type of task (see my attached letter to your office of November 16, 2013)—because the IOM had to admit that it was incapable of developing a new consensus definition of GWI according to the IOM 2014 Gulf War Report. How is HHS going to defend a year from now—when the current IOM committee on ME/CFS will have no choice but to come to the same conclusion regarding the diagnostic criteria for ME/CFS—having wasted another $1 million of taxpayer money given that it is altogether obvious at this point that the IOM lacks the required expertise for the ME/CFS IOM Study?

Given the importance of this issue, I would hope that you would at least afford me the courtesy of a reply that substantively and thoroughly addresses the OCI issue in a way that is logical and legally defensible.

Sincerely,

 

Jeannette K. Burmeister

Attorney at Law

 

Attachments:

My letter to your office of November 11, 2013

My letter to your office of November 16, 2013

My letter to your office of January 7, 2014

 

cc:

Barack Obama, President of the United States of America

Adam Trzeciak, Inspector General, U.S. Government Accountability Office

Senator Harry Reid, Majority Leader in the U.S. Senate

Senator Tom Harkin, Chairman, Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Senator Jerry Moran, Ranking Member, Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Jack Kingston, Chairman, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Rosa DeLauro, Ranking Member, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Lucille Roybal-Allard, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Barbara Lee, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Mike Honda, California, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Tom Coburn, Oklahoma, Ranking Member, Senate Committee on Homeland Security and Governmental Affairs

Secretary of Health and Human Services Kathleen Sebelius

 

[1] http://www.iom.edu/Reports/2013/Gulf-War-and-HealthTreatment-for-Chronic-Multisymptom-Illness.aspx

[2] http://www.iom.edu/Reports/2014/Chronic-Multisymptom-Illness-in-Gulf-War-Veterans-Case-Definitions-Reexamined.aspx

[3] http://www.forbes.com/sites/rebeccaruiz/2013/06/28/inside-the-effort-to-define-gulf-war-illness/

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IOM Meeting: Open? Participate At Your Own Risk

The third IOM meeting of the committee tasked with the development of a new case definition for ME/CFS will be held on May 5th and 6th, 2014.

According to the IOM’s listserv message from yesterday, “[on the afternoon of May 5, the committee will hold an information-gathering session that will be open to the public. Interested individuals will be able to attend the open session in person at the National Academies of Science building or virtually via webcast.” [emphasis added] Written comments may be submitted prior to the meeting. If they are submitted by April 23, 2014, the “will be distributed to the committee before the meeting.”

“Open” Meeting

Before people get too excited about the fact that parts of the meeting are open to the public, let’s be clear that the IOM’s understanding of what constitutes a public meting is peculiar at best. There will be no opportunity for the public to participate in the meeting, other than for a few pre-selected, invited speakers. They can hardly be considered “the public.” The public is only welcome to attend the meeting in person (up to a very limited number of people) and via webcast, but there won’t be an open mic for comments or questions and dissenting opinions by the public will definitely not be allowed.

One has to wonder why the IOM deviated from its January 27, 2014 meeting format. The afternoon session of that meeting was also open to the public. But the big difference there was that 15 uninvited speakers were allowed to make comments of 3 minutes each. Could the IOM really not find 45 minutes in its schedule to allow for true public participation? Or was it so threatened by the fact that most speakers expressed their strong opposition to the “study” and the whole IOM process in January that it had to shut that down this time? Is the oh-so powerful and, as we keep hearing, prestigious IOM really that afraid of hearing what patients have to say? Limiting public input to a select few and relegating everybody else to quiet listeners is just another indicator for the disdain that the process has for patients. The IOM is not even trying to give the appearance that it genuinely cares about patients’ opinions. But, then again, we already knew that. The body language of the panel members at the January meeting spoke volumes.

And the possibility to submit written comments is nothing but a red herring. Written comments can be submitted to the committee at any point in time. They will become part of the public record no matter when submitted. Allegedly, if submitted by the deadline, the committee members will read them before the meeting. That may or may not actually happen. But it doesn’t even matter because the real question is whether those comments will carry any weight; more on that below. Spoiler alert: NOT.

So, creating an “open” comment session is the IOM’s way of merely going through the motions. It’s a big charade. But it sure looks good and it’s clearly a great PR move on the part of the IOM.

Comments

The “open” IOM session will address the following questions:

1) In your opinion, what are the most important issues that healthcare providers should be educated about when it comes to diagnosis of ME/CFS?

 2) What are your thoughts on the current terminology used to describe this disease: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome? If you could suggest new terminology, what would you suggest and why?

There has been some chatter on the Internet among patients about whether they should indeed submit comments. People have said that they feel like they are between a rock and a hard place. If they submit comments, their participation could be interpreted as cooperation with the IOM despite many, if not most, patients opposing the IOM “study.” At the same time, patients are concerned about missing an opportunity to educate the panel.

As I have said before, this is a very personal decision and, at the end of the day, we all have to live with our choices. Having said that, it is my strong conviction that cooperating with the IOM by providing substantive comments will do nothing but lend legitimacy to a flawed process that has the very real risk and is, in fact, designed by HHS, to harm this patient population greatly. Why else would the committee be stacked with a majority of non-experts? These non-experts have no business defining a disease that they have no prior experience with.

I truly mean no disrespect to these non-expert panel members. I am sure they are all accomplished in their area of expertise. I am not questioning that, but they are not experts in THIS disease. The Gulf War Illness committee members probably had similarly impressive credentials and good intentions, but we’ve seen the disastrous results of their efforts. The foremost experts for this disease have stated that this effort will harm patients. And yet, here these non-experts are, not having treated a single patient with this disease or researched the disease in any meaningful way or in any way at all. This is not a purely intellectual exercise. It has taken the experts decades to accumulate their expertise by treating and researching this disease and the non-experts are not going to become experts capable of producing an accurate definition by reading about this extremely complex and very unique disease for a bit more than a year in their spare time. What they have been asked to do is simply not feasible to do competently no matter how much they might want to believe it is or how good their intentions or credentials are.

But back to the comments. There is a snowball’s chance in hell that patients’ comments will have the slightest impact. First of all, how did that work out for us when some members of our community provided input on the provisional panel members and their potential conflicts of interest? In short, it didn’t.

Potential conflict-of-interest issues of panel members were supposed to be discussed during the first meeting, on January 27, 2014. That sure did not occur during the open afternoon session. Maybe there was a closed morning session that day. We don’t know because of the secrecy surrounding this “study.” And if that vetting indeed took place in the morning of January 27, 2014, did we hear about how the panel overcame the concerns some patients raised about some committee members? No. All that was achieved by raising conflict-of-interest issues with the IOM was that the IOM and HHS now are able to claim that patients had a say in the make-up of the committee when it fact we did not. We were duped, as many patients predicted. Not a single panel member was replaced as a result of patients’ concerns. The facts speak for themselves.

Providing comments now will be as effective, as in not effective at all. It serves no other purpose than to legitimize a grossly flawed process. It will allow HHS to claim that the IOM “study” had patient buy-in although the vast majority of patients continue to oppose this “study.”

You still don’t believe me? Ok, let me try to convince you some more. It is true that the Statement of Work provides for patient input. However, the clear task spelled out in the Statement of Work is an evidence-based review of the literature. By definition, that rules out taking into account anecdotal patient stories or comments. The Statement of Work, in effect, prohibits giving weight to patient input because that would be outside the scope of the evidence-based review. Clever, isn’t it?

Also, are patient comments reflected in the Gulf War Illness IOM reports? Remember, the best predictor for future behavior is past behavior.

Providing written comments or, if invited, giving comments at the meeting will not make a single difference in the outcome of the “study.” All it will accomplish is for HHS to be able to claim that patients were given a voice and were on board with this farce when most patients familiar with the issue are not.

I know it’s unsettling to feel helpless and to have no control. But submitting comments is not the way to gain any control. The only thing we can control is not to legitimize this “study” by refusing to participate and by continuing our protest.

Therefore, I will not send in substantive comments. I will, however, send a note repeating my strong and unconditional opposition to the “study” and the process. I urge others to resist the temptation to cooperate by answering the questions posed by the IOM. If you do send comments expressing your opposition (if you, in fact, do oppose), I caution against falling into the trap of adding on, “Should the worst happen and this study continue, then I would like the committee to consider the following.” That is still participating substantively. Remember that HHS does not have good intentions as evidenced quite obviously in many ways.

CFSAC patient representative, Eileen Holderman, who clearly understands the danger of cooperating with the IOM declined to speak at the May IOM meeting in her message to the IOM: “For numerous reasons stated below, I must decline your speaking invitation.  I am part of a vast patient advocacy movement that opposes the HHS/IOM Contract to redefine Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).  There are many reasons for my (and other advocates’) opposition …” I encourage everybody to read Ms. Holderman’s entire message to the IOM. It’s powerful and inspirational. It explains the reasons for patients’ and advocates’ opposition to the IOM “study” clearly and convincingly.

Latest GWI Report and New GWI Legislation

Remember that, earlier this month, the IOM was unable to come up with a new case definition for Gulf War Illness: a big $850,000 oops. When it comes to dealing with complex diseases and particularly case definitions, the IOM’s lack of expertise is clearly and painfully exposed. The ME/CFS IOM committee is not more qualified to define our disease than the GWI committee was to define GWI.

Recently, new legislation, the Gulf War Health Research Reform Act of 2014, was introduced. The new legislation proposes “not [to] disseminate or use for research, clinical care, benefits, or any other purpose the results of the report of the Institute of Medicine titled Gulf War and Health Report: Volume 9. Treatment for Chronic Multisymptom Illness.”

All of a sudden the IOM is not that prestigious and respected anymore, is it? I believe that there is a real risk to the reputation of the IOM in the long run if it continues to accept tasks that are clearly outside the scope of its expertise. Although I see the clear dilemma for the IOM here. Most of its work is commissioned by the federal government. The IOM is in a precarious position. If it does not deliver the results ordered by the government, it could lose its biggest source of income.

One can only speculate how the careers of those who serve(d) on IOM panels delivering sub-standard reports will be affected. But I do believe in holding people accountable for their actions, especially when these actions affect hundreds of thousands, if not a million, of sick patients and their families.

Of additional interest is that the Gulf War Health Care Reform Act also requires that any future IOM studies of GWI convene committees consisting of only medical professionals who are experienced in treating GWI patients, an obvious common-sense requirement that is blatantly being cast aside in the case of the ME/CFS IOM “study” as it has been in the GWI IOM “studies.” Should any further GWI studies be contracted for with the Institute of Medicine, the Act would also require (1) obtaining the advice of the Research Advisory Committee on Gulf War Veterans’ Illnesses, a FACA committee, regarding the scope of work and the charge and (2) including not less than three members of the Research Advisory Committee on Gulf War Veterans’ Illnesses.

IACFS/ME Conference in San Francisco

It has been reported that two staff members of the IOM assigned to the IOM study attended last week’s IACFS/ME conference in San Francisco. One would have to assume that the associated expenses were covered under the HHS/IOM contract. It is not immediately apparent why IOM staff members who, as such, are not members of the IOM committee would benefit from learning about the science of ME/CFS. But more importantly, did any of the non-experts on the committee attend the conference? They probably could have learned more about ME/CFS by doing so than by reading the literature of only replicated studies for a few months.

 ***

It’s becoming clearer every day that the IOM needs to be reined and that its dangerously absolute, yet unwarranted, power needs to be limited.

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The IOMperor Has No Clothes: IOM Admits Lack of Expertise

Apparently, Kenneth Shine, former president of the Institute of Medicine (IOM) and chair of the IOM committee that was tasked by the VA with the development of a case definition for Gulf War Illness, had a gut feeling about the outcome of the study.  Shine stated last year that he “could not recall when the IOM was last charged with defining a disease.” Guess what:  The IOM hadn’t developed a case definition then and–even though the report was released today–it still hasn’t! Wait! What? Well, at the price tag of $850,000, the IOM was “unable to develop a new consensus definition of CMI given the lack of uniform symptoms, the variety of symptoms, and the long onset and duration,” according to the  report. That’s a big taxpayer “oops,” wouldn’t you say?

The VA [had] asked IOM to develop a case definition for CMI as it pertains to the veteran population who served during the 1990-1991 Gulf War, as well as recommend appropriate terminology for referring to CMI.” The IOM simply couldn’t do it. In its report, it basically admitted to not having the required expertise.

Now, is everybody convinced about the IOM’s lack of expertise to define ME/CFS? A literature review by a majority of non-experts is as a flawed a process as one can imagine for the definition of an overwhelmingly complex disease, such as ME/CFS. It cannot be done competently. The latest IOM report makes it a point in a number of places to compare the complexity of GWI with that of ME/CFS. Expecting a different result from the IOM in the case of ME/CFS is the stuff Harry Potter books are made of (no offense to R. K. Rowling). The only difference will be that the taxpayer bill, at $1million, will be even higher.

Jim Binns, chair of the Research Advisory Committee on Gulf War Veterans’ Illnesses, a FACA committee, like CFSAC, commented, “The conclusions of the report show that it was a waste of money.” He further stated, “The committee never had the expertise or the process to do a case definition. It’s good they didn’t do one.” No kidding!

According to Binns “[i]t is hardly surprising that based on a literature review alone, the committee was not able to develop a new case definition … this fruitless process cost VA $850,000.

Remember the following right-on quote by Byron Hyde, renowned ME/CFS expert from Canada?

Definitions are not diseases, they are often simply the best descriptions that physicians and researchers can offer, with their always imperfect knowledge, to describe a disease.  Good definitions are good because they correspond closely to the disease state being described.  It is thus important that those that attempt to define any disease or illness … have long term clinical experience with patients with this illness.  There is simply no place for the bureaucrat in defining illness.  All definition of epidemic or infectious illness must be based upon persistent clinical examination of the afflicted patient, an understanding and exploration of the environmental factors producing that illness, and pathophysiological examination of tissue from those patients.  For similar reasons, I believe that the inclusion of psychiatrists in the defining of an epidemic and obviously disease of infectious origin, simply muddies the water for any serious understanding of that disease. (emphasis added)

It takes expert clinicians to define ME/CFS. The IOM ME/CFS committee consisting of a majority of non-experts does not have the required expertise, just like the IOM GWI committee didn’t. The emperor just doesn’t have any clothes, plain and simple.

I have not reviewed the report in detail, but one thing that struck me on a cursory review was that the report seemed quite repetitive and, one might say, without even an overlay of the kind professionalism that one would expect from an institution that is being touted by HHS as one with utmost credibility.

Speaking of credibility, Simon Wessely, arguably the most controversial figure in medicine and science of our time, reviewed the latest IOM report. Studies that Wessely co-authored are also cited on numerous occasions, so he basically reviewed and signed off on his own “research.” Even if Wessely were right with his psychobabble and pseudo science—and we all know he is not—I cannot imagine what could have possibly gone on in the minds of those who chose him as a reviewer. By doing so and allowing his name on the report, the IOM lost all credibility, whether it be due to indifference to the tremendous controversy surrounding Wessely or due to the lack of due diligence, i.e., ignorance of the controversy.

HHS, can you hear us now?

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CFSAC Meeting December 2013: Webinar from Hell

There is no way to sugar coat this. The December 2013 CFSAC webinar was a colossal middle-finger salute to the patient community. Despite the webinar format having been a complete disaster in December, we will be treated to another CFSAC webinar tomorrow; patients can hardly wait, so it seems like a good time to recap.

What was wrong with the December meeting? Well, how much time do you have? This is not a rhetorical question. The sheer number of glitches, the unmistakable indifference exhibited by CFSAC’s Designated Federal Officer (DFO), Dr. Nancy Lee, to the many patient concerns raised in advance and during the meeting, and the mind-boggling degree of incompetence in running and mishandling the meeting will make this a long blog post. It will outrage you. The DFO’s statement that the snags were “extremely sub-optimal” was a massive trivialization. After attending that CFSAC webinar, it was no surprise to me anymore that HHS botched the Obamacare website as badly as it did; it can’t even run an old-fashioned webinar halfway competently. But there was a consolation prize and that was the unintentional and unexpected entertainment value of the meeting. So, make yourself some tea, get comfortable on the couch or in bed and brace yourself for the ride.

The Watered-Down Format for the “Chronically Tired”

The reason we were given for the new “webinar” format was budget constraints due to the Sequester. We were told that all federal advisory committees had been asked to move to the webinar format, though we have yet to be given examples of other committees having done so. But then again, we, the “chronically tired” ones, are used to receiving only the absolute minimum. Here is a question for everybody: How much money do you think was saved by not having an actual in-person meeting? True, there were no travel or hotel costs for the committee members. However, I bet there were a number of test webinars for the committee members and the IT people before the live webinar to make sure everything would run smoothly. Sadly, the test runs were sorely inadequate, as became painfully evident on December 11, 2013, the day of the meeting. Picture the worst webinar you can possibly imagine and then multiply that by ten. That’s how bad it was. More about that later.

Also, one could speculate whether the “post-production” cost of synchronizing the audio with the slides and making both available on the CFSAC website aren’t aren’t similar to simply putting up the video that is recorded during an in-person meeting and, thus, readily available right after the meeting. Certainly the fact that the audio and slides have not been uploaded to the CFSAC website yet, nearly three months after the meeting, suggests that there is more work than normal involved. But here is the kicker: As I said, there is going to be another CFSAC webinar tomorrow. If anybody is inspired, maybe an FOIA request inquiring about the alleged cost savings of having two webinars vs. one in-person meeting is in order. Although, unless you can afford to front thousands or tens of thousand of dollars in attorney’s fees for a federal lawsuit, don’t bother because HHS seems to view the federally mandated deadline of complying with FOIA requests as optional, which is why I was forced to file a lawsuit against HHS and NIH in federal court in January of this year. So, an FOIA request may well be ignored (again) and chances are good that a lawsuit will be required to enforce your federal right against HHS. But I think we can all guess whether there are any real cost savings with the new format even without seeing the numbers. However, if HHS wants to make the numbers publicly available, I am sure that would be welcomed by the patient community.

Bad Weather: The Missed Opportunity for an Out

The December webinar was cut from two days to one day because of a snowstorm in DC that shut down the federal government. Can’t blame anybody for that. These things happen. But the way the situation was handled was repugnant. Instead of rescheduling the entire meeting, the already truncated meeting was further shortened to one day.

In the past (until May of last year), we had two 9 to 5 meetings, a total of 16 hours. By refusing to reschedule the meeting, it got cut to five hours, less than one third of the normal duration of the meeting. Furthermore, the five-minute public-comment slots for the second day were slashed to three minutes. HHS couldn’t be more obvious about being entirely dismissive of patients’ cognitive limitations if it tried. Requiring patients to—overnight—essentially cut their comments in half was the opposite of accommodating a disability. It made it impossible for some patients to participate in the meeting in a meaningful way for no other reason than their disability, which you’d think HHS is aware of. You’d think.

The weather gave HHS the perfect opportunity to save face and resume the original in-person format. HHS had been given a second chance here to do the right thing. Because the huge elephant in the room was that the DFO chose to hold this meeting as essentially a teleconference at the, by far, most critical time in this patient population’s history: the IOM “study” proceeding despite overwhelming protest by experts and patients alike and despite an unprecedented unity among experts and patients in that regard. HHS had a chance to avoid appearing as egregiously disenfranchising patients more and more at mind-blowing, accelerating speed by returning to a two-day in-person meeting using the weather as an excuse. It did not do so despite the fact that HHS had already rescheduled the meeting once, and this time, it was much more appropriate to do so.  The reason given for the prior rescheduling was the government shutdown. Mind you, the November 2013 meeting was scheduled for about four weeks after the end of the government shutdown. Plenty of time to proceed with the meeting as planned. Postponing then till December, as HHS did, was a lot less justified than it would have been in December.

Tomorrow’s meeting is a make-up meeting for the canceled day in December. Those members of the public who had a speaking slot on the day that the meeting had to be canceled in December will get to speak at tomorrow’s meeting. However, what’s most curious is that back in December, the speaking slots for the public were initially slated for five minutes and only cut to three minutes when the first meeting day got canceled altogether. Tomorrow’s public-comments slots are for three minutes only as well. Does that make sense to anybody? If five minutes were planned in December, why only three minutes now?

Video Testimony Without, Wait for it, Video

For the first time, pre-submitted videos were allowed as public comments. However, only the audio portion of those comments was streamed. Of course, the public was not informed of that not-so-small detail before the deadline for the video submission. Not showing the video portion of video comments is so much beyond bizarre that I at first didn’t believe it when I heard it. Which reasonable person in their right mind would assume that the video part of video testimony (!) will be excluded? It was 2013 and even though D.C. is not Silicon Valley, I am sure proper webinars—you know, with audio and video—have been provided by government agencies in the past.

The reason given by HHS: The webinar platform is not compatible with playing videos. Why in the world was this webinar platform chosen then? And, yes, patients reported that Seamon Corporation, the company whom many aspects of the running CFSAC meetings is outsourced to, confirmed that HHS had the choice of running a proper webinar. You know the kind that everybody is using these days and has been for over a decade: the kind that allows for video streaming. HHS chose to go with the rudimentary audio-plus-slides-only version. You’d think that reducing the meeting to a webinar is enough of a slap in the face. But in case patients didn’t get that not so subtle point, HHS made sure to basically hold a teleconference only, yet calling it a webinar.

The CFIDS Association of America Disseminating Official Government Information?

The CFSAC listserv sent an email with the updated agenda for the second day of the CFSAC meeting 1.5 hours before the start of the meeting. This was our only official (coming from HHS) indication that the second day of the meeting would indeed take place. Interestingly enough though, the CFIDS Association of America (CAA) was not only informed the previous day that the second day was indeed on, it was also either tasked with notifying the public of official government business or took it upon itself to do so because it published on its Facebook site, at around 5:30pm Pacific, the revised agenda the night before the meeting. See the screen shot below, courtesy of Leela Play. The Facebook post didn’t stay up long. In what seemed to be a cowardly move, the post was deleted fairly quickly without any explanation when people started asking questions about whether the CAA is now not even pretending anymore to be separate from the government. But maybe more importantly, does the disseminating of official government information by a non-government agency, before HHS did, constitute a violation of federal law or regulations?

That CAA Facebook post also stated, “As always, ALL are welcome to join in.” This was particularly ironic because until the previous day, when HHS opened up the meeting to everybody regardless of registration, the meeting was limited to 500 pre-registered participants. Some serious questions were raised by patients whether limiting the meeting so drastically still qualified it for a public meeting. Those questions remain even after opening up the meeting to everybody at the last minute, as many people likely did not know about that change, which was buried in a CFSAC listserv message sent the day before the meeting. I know there were patients who did not sign up for the meeting although they were interested because they didn’t want to take a slot away from folks who are more actively involved in advocacy than they are. In light of all this, CAA’s cheerleading seems particularly tone-deaf, even for  CAA standards.

CAA Screen ShotIOM

After Dr. Koh’s remarks, which I (and many others) missed entirely due to the unclear audio instructions (see below), the DFO talked about the IOM-study process and answered questions. I am not going to go into detail about that part of the meeting. I addressed some of those issues—those relating to the DFO’s threatening emphasizing of the dangers for the community in criticizing the IOM process, namely the likelihood that such criticism would backfire on patients—in a prior blog post, “HHS and the IOM Saga: The Definition of Insanity and a Bad Case of Stockholm Syndrome.” There is much more to say about this part of the meeting, but I will leave that for a future blog post.

Government Intimidation

However, one point cannot go unanswered, as it was disgraceful for any democracy and certainly the democracy of the United States. I did not live in East Germany for 18 years, see the Berlin Wall fall and become a proud and upstanding U.S. citizen to stand idly by while the U.S. government is trying to suppress free speech and, even worse, attempting to recruit fellow patients to do their handiwork for them.

Here is what I am talking about: The DFO made a strong point to accuse some advocates of “much vitriol and personal attacks in emails and in blogs around the IOM study.” She talked about some unnamed advocates apologizing for “the vitriolic behavior of another advocate” whom she also didn’t name. Maybe the most appalling statement the DFO made was to call for the advocacy community to “call out and reel in,” in the future, those advocates whose comments and opinions she doesn’t approve of.

Ms. Eileen Holderman, the patient advocate on CFSAC, who has reported having been threatened (together with two other CFSAC members) by the DFO, swiftly called out the DFO for indicting the advocacy community with her comments. Dr. Marshall, CFSAC’s Chair, tried to shut Ms. Holderman down citing time constraints, but Ms. Holderman insisted that she “could not let [the DFO’s statement] stand” and the Chair relented by giving her one minute. Ms. Holderman pointed out that most, if not all, of the discourse around the IOM “study” had been civil and constructive and called the DFO’s accusation unfair.

Being one of the advocates who has been very vocal about the IOM “study,” I can firmly say that I stand by everything I wrote. I can also say with certainty that I have not seen any vitriolic behavior on the part of other advocates nor have I seen personal attacks on anybody. In fact, the patient community, even those of its members who don’t agree on many issues, seems to be pretty much in agreement that advocates have behaved nothing but professionally. I don’t know if it’s more amusing or disturbing to see government officials whining when their position, competence, expertise, action or anything else related to their official capacity is criticized, especially in a field where patients have been harmed by government agencies for decades, as pointed out by Ms. Holderman. It’s bad enough that the government is not listening to, but, in fact, is harming, patients—the latest and maybe the worst example being the shoving down our throats of the IOM “study”—but it’s adding insult to injury to be accused of being vitriolic just as a result of appropriately expressing criticism. Not that the ad-hominem-attack charge is a new tactic at all. HHS took a page out of Simon Wessely’s playbook of unsubstantiated death-threat accusations.

Should there be any doubt, advocacy is politics and politics, if it’s to be effective, is not always pretty. Imagine a U.S. president whining about attacks from the other side of the aisle. A pretty ridiculous thought, no? ME patients are fighting for their lives. The kid gloves came off a long time ago, maybe when the CDC misappropriated funds for our disease in the 1990s? It’s unfortunate that a member of the administration would feel the need to use the power of her position and the platform it bestows—CFSAC meetings she tightly controls—to call people out who are availing themselves of their First Amendment rights, whether it’s due to being overly sensitive or using a tactical ploy.

This should be obvious, but since it’s apparently not, let’s be very clear. If you are a government official and your work is being criticized, even if harshly (with very few exceptions, such as comparisons to Nazi Germany), that is not an inappropriate or personal attack. Everything that has to do with official government business—as opposed to the private life, the appearance, the personal choices, such as religion, etc. of government employees—is most definitely fair game.  The DFO’s comments at the meeting in that regard were quite frankly contemptible and reprehensible and one can only hope that they were not blessed by her superiors. But they were not off-the-cuff statements. Rather, they were clearly prepared well in advance, as the DFO was anxious to read them at the end of the session. Trying to split the patient community by inciting attacks on inconvenient advocates is inexcusable and pretty much as low as it gets.

By the way, I don’t know this for sure, but I have a feeling that those inconvenient advocates might be even more resolved in their will to continue fighting the good fight as a result of the DFO’s shameful comments. If they were easily intimidated, they probably wouldn’t have taken a strong stance on the IOM issue in the first place. Like I said, just a hunch. So, it remains to be seen if this attempt by HHS to quiet some advocates will be successful and if other advocates will be complicit in it.

In that context, you might find the recent articles by Glenn Greenwald, “Internet Trolls May be Trained Government Agents According to Leaked Document” and “How Covert Agents Infiltrate the Internet to Manipulate, Deceive, and Destroy Reputations” interesting. Greenwald talks about a number of tactics the government utilizes to disrupt online discourse, such as the use of online trolls with fake personalities who infiltrate online communities as well as attempts to destroy the reputation of advocates.

The Most Incompetently Run “Webinar” in the History of, well, Webinars

Many emails were sent to the DFO on the days before and of the meeting imploring her to reschedule the meeting and pointing out the many problems with the webinar format and the truncating of the meeting to one day. Here and here are my pleas. I don’t know if others were luckier than I was, but none of my emails to he DFO and/or the CFSAC mailbox were replied to, neither before, during or after the meeting.

Others have written about the multiple problems with the webinar format for patients and about the technical glitches, so I will just mention a few examples:

  • Many patients cannot afford to spend five hours of cell-phone minutes on a webinar. This patient community is predominantly poor. To borrow from one of Dr. Peterson’s examples, many patients live in their parents’ basement because of their poverty level.
  • For the same reason, some patients use a dial-up Internet connection. That means that they can either be on the phone or on the Internet. Since one had to call in for the audio portion of the “webinar” (see below), those patients were not able to follow the slides on their computer screen.
  • Again, due to the financial realities for patients, some do not have fancy phones with speakers.  Yet, many patients are too sick to hold a phone up for five hours.
  • It wasn’t always clear who was speaking because speakers didn’t always identify themselves.
  • It was impossible to follow the text on the screen, as it was quite choppy and patients started complaining about nausea soon after the webinar began.

Many of these problems were pointed out to the DFO via emails after the beginning of the meeting to no avail, despite the fact that they made it impossible for people with disabilities to participate, which raises additional questions regarding the open nature of the meeting.

In order to see the slides on the screen, one had to be in full-screen mode. There were no instructions to that point and patients missed many or all of the slides because of that. That may have just been as well because of the unbelievable IT difficulties in advancing the slides. At some point, it seemed that everybody on the committee was able to advance the slides and since many committee members did so in an attempt to help out, it took minutes to get the situation under control by finally putting Paul, the IT guy, in charge. It was most comical, but understandably seemed quite frustrating to the speaking committee members.

One of the “highlights” of the webinar was the fact that one had to actually call in to get the audio portion of the meeting. So, not only did the “webinar” platform not allow videos, it also didn’t allow audio. Quite the “webinar,” huh?!

This was not explained anywhere in the instructions ahead of time. As a result, I (and many others) missed the first part of the meeting trying to figure out what was going on by emailing with the Seamon Corporation and the CFSAC mailbox. After I, and probably others, made the DFO aware of this via email, the meeting was not halted to send an email from the CFSAC mailbox to everybody and to give people time to figure this out. This would have been especially important because the by far most crucial topic of the meeting, the IOM “study,” was the first agenda item after Assistant Secretary’s, Dr. Koh, short opening remarks.

About 25 minutes into the meeting and after complaining about the missing sound component in an email to the DFO, I received an email from Seamon Corporation notifying me of the requirement to dial into the meeting with my phone. There never was a CFSAC listserv announcement to that effect. Although, at some point during the meeting, the meeting website instructions were quietly updated. Below are screen shots showing the before and after.

Before:

Audio Instructions Screen Shot BeforeAfter:Audio Instructions Screen Shot AfterSeamon Corporation has in the past contacted speakers about their public comments, e.g., to confirm or change the comment time. However, here, where it was probably more crucial than ever because people’s comment time was cut to three minutes at the last minute, no such calls were made. Commenters who might not have checked their emails would have been unaware that they now only had three instead of five minutes for their comments.

The technical difficulties the DFO had trying to call the public-comment speakers resulted in a lot of wasted time during an already extremely short meeting. We had to wait for about a total of 15 minutes for the DFO to call seven patients who had three minutes each to comment and some patients did not use the full three minutes, so that makes a total of less than 21 minutes of comments. I believe nothing else needs to be said here.

There also didn’t seem to be an effective mechanism in place for the Chair to keep track of who on the committee raised their virtual hand first and in what order to allow committee members to speak. There certainly was no accountability for the Chair to be fair and honest in that regard since the public did not actually see in what order the hands went up.

The Chair and the DFO seemed to struggle to figure out how to get the wording for a proposed recommendation drafted by Susan Levine to all committee members for a vote. Put it in a slide? Send it as an attachment to the DFO and the Chair? That’s the problem when you don’t have an in-person meeting. Again, a lot of time was lost just figuring that out at a meeting that was already inadequately short.

Finally, we didn’t get an update from the FDA on the number and types of new drug applications for ME/CFS despite a non-committal comment during the last FDA-patient call that such update might be provided at this CFSAC meeting.

CFSAC’s Patient Advocate Ms. Eileen Holderman

The term of our patient representative on CFSAC, Ms. Eileen Holderman, will sadly be up in May of this year. As always, Ms. Holderman was a very strong advocate for us throughout the meeting.

She voiced her concern about the continuing medical education (CME) videos on the CDC website, as the physicians in them used the Fukuda definition as opposed to the more appropriate (because much newer and more sophisticated and accurate) Canadian Consensus Criteria (CCC) and as cardio-pulmonary exercise testing (CPET) wasn’t mentioned in them at all. Dane Cook, another voting CFSAC member, called Ms. Holderman’s criticism armchair quarterbacking and said that it would have been more reasonable for Ms. Holderman to ask for additional videos. I fail to see the logic in that. If a video contains wrong information, especially regarding a mostly misunderstood disease, it would seem appropriate to pull the video altogether instead of being worried about hurting the egos of the physician who participated in the making of the video, which is what Mr. Cook seemed worried about. CFSAC member Steve Krafchick on the other hand agreed with Ms. Holderman, citing the emphasis of the CME videos on orthostatic intolerance, their lack of mention of CPET, their use of the Fukuda definition, their lack of mention of the IACFS/ME primer and their reference to the CDC toolkit.

Ms. Holderman later stated her disappointment in the attempt by Dr. Elizabeth Unger of the CDC to rein Ms. Holderman in with respect to her CDC-website review, which has been very extensive over the last three years. According to Ms. Holderman, Dr. Unger informed her in two emails that she was deemed to have overreached in her mission and that such comprehensive review was never envisioned by the agency. It came as no surprise then when Ms. Holderman stated that she felt that, despite some progress having been made with respect to the CDC website, for the most part, change has been resisted by the CDC.

Ms. Holderman further pointed out that addressing the education of health-care providers, the subject of a working group report by Susan Levine, was “putting the cart before the horse,” as logically, we first need a consensus on a case definition. Otherwise, health-care providers are potentially being taught the Oxford or Empirical case definition (both defining the condition of fatigue as opposed to the neuro-immune disease ME/CFS) or the Fukuda definition, which does not require the hallmark symptom of ME/CFS, post-exertional malaise.

In addition, Ms. Holderman objected to the formation of the working groups because those were never voted on by CFSAC and, in her opinion, were imposed on CFSAC by HHS. Her concern is that these working groups undermine the sub-committees, which she sees as very functional.

She also mentioned, but didn’t elaborate, that she wasn’t allowed to be involved in establishing the agenda for the meeting as she had been in the past in her role as a member of CFSAC’s leadership committee.

In her parting comments, Ms. Holderman said that she felt that CFSAC’s recommendations have unfortunately largely been dismissed—no surprise to anybody who has been following CFSAC over the years—and that she is hoping that that will change in the future. She also expressed concern about the leadership committee being in peril and the fact that Assistant Secretary, Dr. Koh, is no longer participating in the leadership-committee meetings. The latter in particular certainly is alarming and seems to warrant looking into. Whoever will succeed Ms. Holderman in her role as patient advocate on CFSAC most definitely has some very large shoes to fill.

Other Committee Members

Dr. Ken Friedman, a CFSAC liaison member, reminded everybody of the “institutional reluctance” to allow ME/CFS research, which still seems rampant. He cited several cases of CFS researchers at academic institutions having been discouraged from doing ME/CFS research or having been told that, if they did not cease doing ME/CFS research, their academic positions would be imperiled.

In his parting remarks, Dane Cook, whose term is also almost up, said that he feels that in-person meetings are important and should be implemented again because “people need to be held accountable on a face-to-face basis.”

Even the Chair conceded that webinars are not the best format for CFSAC meetings and that in-person meetings would be preferable. But astonishingly he still, for reasons known only to him, called the December meeting “very professional.” He also made excuses for the mishandling of the meeting by referring to the fact that [they] didn’t anticipate that the meeting would be that problematic. I confess that I find this disingenuous. How do you not notice during the practice runs that you’ve got a big problem? But more importantly, why do you choose the same dysfunctional format for tomorrow’s meeting? What’s the excuse going to be if tomorrow is equally as excruciating?

At some point during the meeting, the DFO apologized and explained the glitches with the fact that the webinar format was new to [them] and the IT people, which begs the question why they chose a format they so obviously couldn’t handle. The attempt to disenfranchise patients backfired painfully for HHS. And this once, the pain was not only on the patients’ side.

What to make of it all?

I have rarely seen Facebook and Twitter explode that much in this patient community as it did on that day. Patients could not have felt more disrespected and disenfranchised, which was remarkable given the community’s low expectations in HHS. They were angry and completely exhausted early on during the meeting due to all the confusion and glitches. But then something interesting happened pretty quickly. People, even those who don’t always agree on every issue, bonded. They united. They had a strong voice on social media. And they made the most of this disaster. They used humor to get through it. The material was endless and would have done a Daily Show or Colbert Report segment justice. One of my posts on Facebook that day:

The words of the day: “Can I have the next slide, please? Next slide? Next slide? Hello? Can anybody hear me? Can I have the next slide?”

Somebody else quipped:

Three minutes for comments. Five minutes for Dr. Lee to learn how to throw the switch.

(I’d like to give credit to the person who said that, but can’t remember who it was. If it was you and you feel comfortable being named, please do let me know.)

On a more serious note, the disrespect that HHS has demonstrated with regard to the handling of this meeting is unprecedented and truly astounding. The meeting was run so poorly that patients called for the DFO to be replaced by somebody with more competence and appropriate behavior and less bias towards the ME/CFS community. Of course, Assistant Secretary Koh blew off those requests and complaints with platitudes, just like he had with respect to Ms. Holderman’s report of the DFO’s threat towards her and two other committee members.

The link on the CFSAC website to tomorrow’s meeting, “View the presentations and listen to the webinar,” is not working (see screen shot below), which definitely doesn’t bode well for a successful meeting tomorrow. Yet, the December meeting set the bar so low that it is hard to imagine that it will be worse tomorrow, but I certainly don’t want to jinx anything.

Screen Shot Faulty Link

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