December 2014 CFSAC Comments: HHS’s Complete Disregard for Law and Health of Patients

Posted on December 3, 2014 by Jeannette Burmeister

In January, I sued HHS and NIH for violation of the Freedom of Information Act, FOIA, in connection with my FOIA request for documents relating to the IOM study. I won the lawsuit by prevailing on my summary-judgment motion for a proper document production.

The Federal Court held that “the government’s conduct throughout its dispute with Ms. Burmeister was unreasonable” and awarded me my entire attorneys’ fees of over $139,000.

True to form, HHS and NIH have not paid or even committed to paying in spite of my numerous requests.

I did everything in my power to avoid legal fees, for example, I sued without attorneys at first. Yet, the government fought me tooth and nail trying to avoid compliance with federal law and to delay production of responsive documents as long as possible, necessitating my engaging attorneys at the government’s, hence taxpayer’s, expense. The defendants have consistently acted inexcusably and shamefully, really, in their relentless attempts to circumvent their FOIA obligations. They filed a frivolous summary-judgment motion five months into the litigation when they could have used all that time to simply remedy their FOIA violations. Two months later, they doubled down by filing another brief making meritless legal arguments and misstating the law and the facts—the latter, under penalty of perjury. After they lost, they wrongfully accused me of lying.

HHS and NIH have directly caused my health to dramatically deteriorate as a result of their deplorable conduct. They have done everything to prolong this litigation and drive up my attorneys’ fees, arrogantly not anticipating the Court’s ordering them to reimburse me. The DOJ, in defending and enabling this behavior in Court, acted in direct violation of the Attorney General’s instructions to defend only the denial of FOIA disclosures prohibited by law or involving exemptions. Neither was relevant here.

HHS and NIH have acted like bullies vis-à-vis a disabled ME patient just to be ordered by the Court to do what they should have done more than nine months prior, without a dime spent and without any additional damage to my health: to produce the requested documents. The Court-ordered recent document production was again not FOIA-compliant and my attempts to settle the matter out of Court have generated more government stonewalling and meritless arguments and may leave me no choice than to ask the Court to enforce its orders and/or find he defendants in contempt.

And that, committee members, is what you and patients are up against. A complete disregard for the law and the health of patients by HHS.

Thank you!

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P2P FOIA Documents, Part 7—Collins, Murray and Maier: Trouble in NIH Paradise

Posted on November 23, 2014 by Jeannette Burmeister

David Murray’s (Director of NIH’s Office of Disease Prevention) noticing of a ProHealth blog entry started an avalanche of bizarre email exchanges within NIH that included, among others, Francis Collins, James Anderson and Larry Tabak. I received these emails after winning my IOM lawsuit.

Murray was worried about the ProHealth piece calling NIH out for the ridiculously small amount of NIH funding our disease receives. He rings the alarm bells over the bad PR (page 1):

… reporting that chronic fatigue syndrome funding has declined while “NIH funding levels explode.” Right now the organization is spending approximately as much on CFS as it was in 1992. Is asserts for this reason that “The NIH’s ‘commitment’ to ‘enhancing the health” of people with Chronic Fatigue Syndrome has declined over time,” devoting under .02% of its budget to the disease, or $6.00 per patient.

It made me wonder if we should put something on our website about the upcoming P2P workshop on this topic.

Once again, zero concern for the facts, i.e., that our disease receives a pittance from NIH, or any attempt to improve NIH’s track record on that front. No,  Murray went straight into how-can-we-make-it-look-better-than-it-is mode. Let’s put out some info about some ludicrous workshop, the P2P, on our site. That’ll appease the masses and might field some uncomfortable inquiries from Collins concerned for the image of his agency.

Murray then sends a draft message intended for Collins to Paris Watson, Jody Engel and Wilma Cross Peterman for their input. Engel has a comment that we are not allowed to see (page 7). Cross suggests to add a link to the P2P link (page 9). Because, you know, they put all that work into the new shiny P2P site.

Then, just before sending his message to Collins, Murray to Paris Watson (page 11):

I need to clarify the purpose of the workshop. It is supposed to be used by [three lines of redactions].

So, the Director of ODP is in the dark about the purpose of the P2P. Very comforting, although maybe not surprising. After all, we are talking about a disease that is highly controversial (and thus, not a disease topic the P2P program is supposed to be used for, according to NIH’s own rules) and that already has another redundant HHS redefinition effort under way, the IOM “study” (redundant because the experts already agreed on a definition, the Canadian Consensus Criteria). Of course, we are not allowed to see the response email(s) even though no exemptions have been claimed. But then again, not producing responsive documents in reply to a FOIA request is standard HHS operating procedure. I digress …

Murray sends his message to Collins copying Anderson. One of the things he says (page 15):

Let me alert you that ODP has been planning a workshop on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) as part of its Pathways to Prevention workshop series for more than a year.

In a later email to Collins, Murray added (page 16):

Our planning had been underway for sometime when we learned of IOM’s interest in this topic.

Now isn’t that interesting?! Don’t these folks talk to each other?  Because that is pretty much the same point in time that Nancy Lee started working on the IOM “study.” Way to waste money on the duplication of efforts for a disease that hardly gets any money to start with.

What I find even more interesting is the “IOM’s interest in this topic.” So much for the IOM being independent of HHS. We all knew that this was a meaningless talking point, but stay tuned for more interesting revelations on that front.

Anderson promptly asks (page 14):

Remind me- the goal of the ODP WS is to provide a research definition for ME/CFS. We are not wandering outside that box. The IOM meeting, [redaction].

So, now Anderson, Deputy Director at Collins’ office, is also unclear about the difference between the IOM and P2P projects.

Murray replies to him (page 14):

[The IOM has] invited Susan Maier from ORWH to participate in their first meeting later this month to discuss the P2P workshop so as to avoid duplication of effort.

Well, since we know from Nancy Lee that the IOM is also going to address the research side of things, what Murray was really saying is “so as to avoid the appearance of the duplication of efforts.”

But Murray’s sale pitch to Anderson is mainly this (page 14):

The community has felt that research in this area has been stalled because of the lack of agreement around the diagnostic criteria.

He seriously said that. Never mind that there is consensus among the experts on using the CCC as the research definition. Thus, the patient and advocacy community’s outcry over these redundant undertakings, the IOM and the P2P. And never mind that research in the area is not making much progress because the definitions that have been used in the few NIH-sponsored studies (despite having the much more accurate CCC and ICC available) are so senselessly broad—not requiring PEM or only requiring six months of fatigue—as to include many patients who do not have ME. No wonder progress is painfully slow. Not to mention the lack of a meaningful amount of funding from NIH. I wonder what kind of study our experts using the CCC could have performed using the money that HHS is blowing on the P2P (and IOM).

Not surprisingly, Collins is not buying it and Anderson asks Murray for a follow-up message to Collins (page 14):

I think Francis needs a follow-up email explaining how the NIH and IOM goals are different. … [redaction] Blame it on me.

Francis needs a follow-up email?  And he can’t ask for that himself? Really?

So, now we have three high-level NIH officials, Murray, Anderson and Collins, not knowing what is going on with P2P.

But wait! It gets better.

Larry Tabak, Principal Deputy Director at NIH, who was copied on Murray’s email to Collins is asking Collins and Murray (page 26):

As I recall HHS was planning on sponsoring a workshop on this in FY14 that NIH is a co-sponsor of; Janine [Clayton] may know the details …

Interestingly and sort of out the blue, Collins replies to Murray (page 23):

Thanks for the heads up. I hope there will be some attention to the microbiome as part of this CFS workshop.

If Collis wants the microbiome to be studied in “CFS,” why isn’t he funding it? Ian Lipkin recently received a $31 million grant from NIH (for the study of—among other things—the microbiome, just not in CFS).  And yet, Lipkin is having his ME/CFS grant proposals rejected because NIH believes that our disease is psychosomatic. Moreover, how is a so-called evidence review supposed to contribute to the knowledge in the “CFS” microbiome field if there is no evidence because very little was funded by NIH and even that only recently with no results yet?

At this point, Murray has just about had enough and he vents to Cross (page 25):

My initial note this am stirred up quite a series of emails. Jim [Anderson] was concerned that Francis might not understand the differences between the IOM effort and ours, so I consulted with Paris and Susan Maier and sent a follow-up note to Francis. Then Francis raised the issue of the microbiome and Larry raised the specter of yet another workshop. I am trying to find out if this “other workshop” is the IOM meeting.

Oy vey!

Murray is clearly as exasperated by now as he is confused by the various redefinition efforts (page 25):

I hadn’t intended to spend most of my morning on this …

He asks Maier and Watson (page 28):

Do either of you have any information on this? Is this the IOM workshop that the 3 of us have been trading notes about this am? Or is there a third workshop being developed that I haven’t heard of.  Dr. Tabak suggested that Janine might have details, so let me ask Susan about this.

Right, that makes sense. If Clayton has information on the matter, let’s ask Maier.

Maier also doesn’t seem happy (page 34):

I have indigestion already … not food-based

Sounds like a somatoform disorder of some kind to me.

Maier gets comforted by a co-worker quickly (page 34):

I wouldn’t let it get to you, however, we will keep watching as it develops. They have these round robin discussion frequently about an issue and then they drop it after they have exhausted it.

If that isn’t a productive way for the executive branch to handle matters! Have round-about discussions for a while and then just drop the issue without any solution.

And do I dare add one last quote from Maier?

I got some lunch (finally). (page 34)

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

Posted on November 21, 2014 by Jeannette Burmeister

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!

Posted on November 12, 2014 by Jeannette Burmeister

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

Posted on November 7, 2014 by Jeannette Burmeister

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

Posted on November 2, 2014 by Jeannette Burmeister

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

Posted on October 26, 2014 by Jeannette Burmeister

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!

Posted on October 21, 2014 by Jeannette Burmeister

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”

Posted on October 19, 2014 by Jeannette Burmeister

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

Posted on October 19, 2014 by Jeannette Burmeister

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!

Posted on September 24, 2014 by Jeannette Burmeister

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

Posted on September 3, 2014 by Jeannette Burmeister

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

Posted on June 16, 2014 by Jeannette Burmeister

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!

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

Posted on May 29, 2014 by Jeannette Burmeister

After watching “Frozen,” 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

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

Posted on May 28, 2014 by Jeannette Burmeister

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:

2013/11/11: Call for Investigation by the Inspector General of the IOM’s Conflict of Interest With Respect to ME/CFS

2013/11/17: Supplemental Request for Investigation by OIG: Did DHHS Violate its No-Bid-Contract Requirements for IOM Contract?

2014/01/08: After OIG Dodges Charge of IOM’s Conflict of Interest, Meaningful Reply Demanded

2014/04/04: IOM-OCI-OIG … OMG!)

 

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

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P2P Review Protocol: Still No Transparency

Posted on May 2, 2014 by Jeannette Burmeister

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.

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

Posted on April 16, 2014 by Jeannette Burmeister

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.

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

Posted on April 7, 2014 by Jeannette Burmeister

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.

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IOM-OCI-OIG … OMG!

Posted on April 4, 2014 by Jeannette Burmeister

[Update: 2014/05/28, OIG Fails to Investigate IOM Conflict of Interest & Tells ME/CFS Patients to Buzz Off]

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 the following blogs posts for my prior letters:

2013/11/11: Call for Investigation by the Inspector General of the IOM’s Conflict of Interest With Respect to ME/CFS

2013/11/17: Supplemental Request for Investigation by OIG: Did DHHS Violate its No-Bid-Contract Requirements for IOM Contract?

2014/01/08: After OIG Dodges Charge of IOM’s Conflict of Interest, Meaningful Reply Demanded

Below 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

Posted on April 1, 2014 by Jeannette Burmeister

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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