Holding HHS Accountable for Unrelenting and Unrepentant Legal Violations

Many members of the community have called out HHS for legal violations over the years, such as Dr. Mary Ann Fletcher and Ms. Eileen Holderman confronting Dr. Nancy Lee, DFO of CFSAC, for her attempted intimidation of CFSAC members by threatening to evict them from the committee for voicing their opinion. This was well documented by Jennie Spotila on her blog. Ms. Spotila also uncovered other FACA violations. I successfully sued HHS and NIH in federal court for violating FOIA and the Judge found the agencies’ conduct to be unreasonable to a degree that led him to order both agencies to pay all of my attorneys’ fees, more than $139,000. The award of attorneys’ fees is by no means a given in FOIA cases; it requires a high level of unreasonableness on the government’s part. I explained why HHS again violated FACA regarding CFSAC’s January 2015 comments to the P2P here, here and here. Many advocates have protested these and other legal violations of HHS in formal complaints and public testimony throughout decades.

It’s almost too obvious to make the point, but the government, in our case, HHS, has a mandate to follow the law. The rules exist for important reasons, in the case of FACA, to protect the integrity of the process through transparency and accountability. Similarly, FOIA is meant to facilitate open government. Those are important constructs that, together with other aspects of our legal system, build the foundation of a principled society. They are not just technicalities that can be shoved aside or overlooked whenever it is convenient for the government. To the contrary, they represent rights of the people that are enforceable in court. It seems what we are seeing is a desensitization to legal violations due to the sheer numbers of times HHS has been violating the law, all the while acting as if nothing was wrong. But it is the duty of a citizen, especially an advocate, not to let that cloud one’s judgment and not to let HHS get away with it. A violation is a violation regardless of how many times it has been committed.

However, a few members of our community prefer to turn a blind eye when it comes to HHS’s unlawful conduct. It is possibly understandable, though not excusable, that HHS would downplay the seriousness of its actions or even misstate the law to the public, as Dr. Lee, CFSAC’s DFO, did again just last month at the latest CFSAC meeting in describing HHS’s disclosure obligations under FACA. But why would patients do it?

For a few, the answer seems to be that they are taken aback when they realize that they participated in a process that was unlawful on the part of HHS, such as a FACA violation. Instead of directing their dismay over these violations at HHS, they turn it against those of us who are holding the agency accountable. When somebody has been passionately invested in a project by volunteering a lot of time and effort, it may be natural for the initial knee-jerk reaction to be pushing back upon hearing of HHS’s misconduct. Cognitive dissonance can be quite compelling. And, of course, HHS is relentless in its denial of its violations, never mind that they are obvious. After decades of neglect and abuse by HHS, wanting to believe that things are finally different—that HHS turned over a new leaf and now has the best interest of ME patients in mind—can become a desperate need reinforcing the narrative that nothing is wrong with HHS’s actions. It’s tough to admit to oneself and others that things were not above board when one was led to believe by HHS that they were on sound legal footing and one relied on that. I get that. However, it is asking a bit much of the community to overlook these serious transgressions by HHS just to allow those who were part of the tainted process to retain their comfort level and alleviate any potential guilt. Once a well-reasoned and well-supported analysis of the law has been presented outlining the legal violations by HHS, there is no longer any plausible deniability.

Nevertheless, a shooting of the messenger, which does occur at times when accountability is demanded from HHS for the agency’s illegal actions, is crossing a line. Not only do a few patients and/or advocates praise HHS despite all its egregious violations, make excuses for the agency and presumptuously and patronizingly apologize to the agency or its component agencies for other patients, they also misstate the law publicly to the community thereby enabling HHS to continue their unlawful pattern. They even go as far as to, often publicly, accuse those who try to hold HHS accountable of being conspiracy theorists, making unsupported assumptions, creating unnecessary drama, reporting recklessly and manipulating the community. They question the value of insisting on HHS’s adherence to the law and instead stress the amount of work that went into an HHS project, as if that somehow offsets the violations. They also deny established facts.

This hurts all patients. It is also a double whammy for the many in the community for whom compliance with the law is not negotiable; they witness HHS break the law time and time again and, when they confront the agency, they face unsupportable accusations by others in the community who enabled, condoned, or acquiesced in, the HHS violations and/or are either not familiar with the law or choose to overlook legal violations, seemingly in the interest of a purported greater good.

The greater-good argument is, of course, a slippery slope. To what degree are we supposed to tolerate legal violations? When do they cross over to becoming inexcusable? Who gets to decide? The law exists to remove those grey zones. In our society, the duty to follow the law is not optional nor is it permissible to follow it selectively.

One person has even publicly suggested that it is improper for an advocate who chooses not to participate in a particular process to later criticize such a process. This is absurd. Usually, the reason the advocate chose not to participate in the process (assuming he or she was given an opportunity to do so) is that the process itself was flawed or tainted. Participating would be tantamount to endorsing the flawed process, such as the farcical jury model of the P2P. Only through the looking glass would this lack of participation force silent acceptance on what ultimately turns out to be not only a tainted, but an unlawful process.

It is important in this context that, once a legal violation has been explained in painstaking detail and the facts are not at all in question and are, in actuality, admitted or otherwise proven—as is the case with the FACA violations that occurred with respect to the January 2015 CFSAC recommendation—the accusation that he who uncovers HHS’s unlawful conduct made misrepresentations of the facts or the law can no longer be claimed to be a negligent attack on that person’s reputation; it’s quite intentional.

This is one of those moments when the M.E. community defines itself. Does it want to insist on HHS’s adherence to the law or condone the agency’s manifest legal violations? Some advocates have been fighting, often at great personal cost, to compel legal compliance by HHS. Others have enabled HHS, actively or indirectly, to disregard the law. Asserting that it is important to “work with” HHS or that legal infringements should be overlooked so as to achieve a purported beneficial end result, they downplay the seriousness of, or even defend, activities or processes that are tainted by unlawful HHS conduct. They also, instead of taking issue with HHS’s unlawful pattern, fault those who seek to hold HHS accountable for its legal violations.

It is crucial that those who stand for accountability of HHS under the law and integrity of the governmental process continue to insist on HHS’s compliance with the law. Pursuing legal violations by HHS gives the community unparalleled leverage in its fight against the agency’s recalcitrance, abuse, contempt, neglect, obstruction, distortions, misinformation and failure to fund. Let’s remain firm in our conviction that going along with HHS’s unlawful methods in order to get along is out of the question for our community.

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Yes, CFSAC, there is a FACA violation

“Yes, Virginia, there is a Santa Claus.”–From an 1897 editorial, “Is there a Santa Claus?” of The New York Sun

I was contacted by a member of the Chronic Fatigue Syndrome Advisory Committee (CFSAC) regarding my blog post, “Oops, they did it again! CFSAC violates FACA.” Below is the part of my answer that I think will be of particular interest to the public, as it spells out one of HHS’s recent FACA violations in more detail.

“I want to thank you for your message in response to my blog post, “Oops, they did it again! CFSAC violates FACA”, as it gives me an opportunity to spell out the FACA violation discussed in the second half of my post in more detail in hopes that it will facilitate a deeper understanding of the seriousness of the events surrounding the January 2015 CFSAC P2P comments.

Pursuant to Sections 5(b)(3) and (c) of the Federal Advisory Committee Act (“FACA”), the appointing authority—here, the Department of Health and Human Services (“HHS”)—shall not inappropriately influence the advice and recommendations of the advisory committee—here, the Chronic Fatigue Syndrome Advisory Committee (“CFSAC”). Instead, according to the law, that advice and those recommendations are supposed to be “the result of the advisory committee’s independent judgment.”

Accordingly, the role of a federal advisory committee’s Designated Federal Officer (“DFO”) is to ensure compliance with FACA (ironic, I know), and any other applicable laws and regulations; call, attend, and adjourn committee meetings; approve agendas; maintain required records on costs and membership; ensure efficient operations; maintain records for availability to the public; provide copies of committee reports to the Committee Management Officer for forwarding to the Library of Congress and to provide other support services for the committee. (U.S. General Services Administration, Office of Governmentwide Policy, Committee Management Secretariat; see also 41 C.F.R. §102-3.120 as well as CFSAC’s charter.) Please note that all these functions are purely administrative in nature, such as handling expense reimbursements for committee meetings. The DFO is not supposed to get substantively involved in the advice and recommendations by the advisory committee.

Those federal rules were clearly violated here. I realize that CFSAC’s DFOs break this particular FACA rule (and others) on a regular basis, but that doesn’t lessen the gravity of each violation. For the DFO, Barbara James at the time, to be involved in any substantive way in the comments constituted a violation. For her to be involved in the disturbingly invasive way that she was just makes the violation all the more egregious. I would hope that all CFSAC members find this obvious violation of the law appalling.

There is no doubt that HHS’s behavior was against the law. Beyond that, I did not suggest that the working group did anything unethical or immoral, but the working group certainly caved to HHS pressure and that was inappropriate. The fact that the group did not acquiesce in one instance—the length of the comments—does not excuse giving in on the more substantive issues. Nobody can, in all seriousness, argue that HHS did not exert any pressure on the working group to make changes to the document or did not affect any such changes, regardless of whether all changes were adopted for the final document. HHS’s making, or lobbying for, changes behind the scenes and hiding that very fact from the public is directly contrary to FACA’s purposes of independence and transparency.

Aside from the glaring legal issue, if CFSAC is going to have any credibility, it has to operate independently of the DFO. The integrity of the process is compromised entirely and the committee’s role is usurped if the agency whose contracted work is to be reviewed by the committee is allowed a veto right and, even more so, when that veto right is afforded up front. The working group draft should have gone to the full committee without any edits made by, attempted to be made by, or caused by the involvement of, HHS. The intact document is what represented the “consensus of the Working Group.” Once any kind of pressure is applied by the committee’s authorizing agency, the independence of the committee is not only undermined, it’s obliterated. The entire committee should have had a chance to review the unaltered working group document, discuss it and vote on it at the public meeting. If the DFO, Ms. James at the time, had inappropriately raised any objections to the draft comments at the meeting, the full committee and the public would have witnessed HHS’s improper attempt to influence the draft recommendation and that FACA violation would have become part of the minutes of the meeting.

You argue that it was the right thing to compromise on HHS’s changes to avoid risking that “the P2P panel would never see [the comments].” I disagree. Regardless of the fact that the ends hardly justify unlawful means, CFSAC should have chosen to avoid any appearance of improprieties. The committee could have had an impact without the Secretary. It should have adopted the recommendation without HHS tampering. If the Secretary had not followed the recommendation and not forwarded the committee’s comments to the P2P panel, that would have spoken for itself in a powerful way. Meanwhile, the CFSAC recommendation would have still remained on the record and members of the public could have and would have submitted the recommendation to the P2P panel.

The position that Ms. James got involved “with the best intentions” is both irrelevant and a leap of faith that seems unjustified given the history of the treatment of our disease by HHS, which includes a very long list of wrongdoings and abuses of the community by HHS and which doesn’t bode well at all for even more government censorship or secrecy. For example, during my FOIA lawsuit against HHS and NIH, false statements under penalty of perjury made by agency representatives were not isolated incidents. Other examples include misdirecting congressional funds in the millions by CDC; almost complete refusal to fund research of our disease by the NIH using pretexts and untruths; misinforming the public, media and medical community about our disease by CDC; conducting unscientific studies claiming, e.g., a connection between sexual abuse and our disease by CDC; creating the meaningless social construct and harmful name “CFS;” ridiculing patients by CDC and NIH; creating overly broad definitions by CDC preventing research progress by diluting cohorts; and frequently committing violations of various federal laws. In addition, vigilance and skepticism were clearly called for given HHS’s history of making changes to CFSAC recommendations, which was documented well by Jennie Spotila.

It is alarming that this improper influence by HHS was tolerated at the time given the compelling objections from at least two working group members. Now that these violations have been clearly exposed, any justification of HHS’s unlawful interference can no longer be maintained.”

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Another CFSAC FACA Fail: DFO Misconstrues Law

On Monday, I published a post about CFSAC violating the Federal Advisory Committee Act (“FACA”) by failing to make the the working group’s draft P2P comments available to the public prior to, or at the time of, the January 2015 CFSAC meeting.

Under section 10(b) of FACA, “the records, reports, transcripts, minutes, appendixes, working papers, drafts, studies, agenda, or other documents which were made available to or prepared for or by each advisory committee shall be available for public inspection and copying at a single location in the offices of the advisory committee or the agency to which the advisory committee reports until the advisory committee ceases to exist.” These documents must be made available no later than at the time of the meeting. When HHS had not made the draft comments available to the public for the January meeting, I requested that document, under FACA, after the meeting in a letter to Barbara James, Designated Federal Officer (“DFO”) of CFSAC at the time. I received it in March along with other documents, which is posted and analyzed in my Monday post.

In an apparent attempt to counter my FACA-violation charge, the current DFO, Dr. Nancy Lee, addressed the issue at Tuesday’s meeting:

“We are not required to send these [documents prepared for the meeting] out in advance of the meeting [other than to committee members] because they are pre-decisional. … [W]e are not required to post them on the website because they are pre-decisional.”

Dr. Lee’s excuses for HHS’s failure to comply with FACA fall flat because she is plain wrong regarding the requirements of FACA.

First of all, she seems to combine two arguments. It appears she is saying that HHS is not required to

  • email the relevant documents to the public or post them on the CFSAC website in advance of the meeting nor
  • disclose them at all because they are pre-decisional.

I and numerous other advocates wrote to Ms. James ahead of the meeting in January, saying that “the public should see” the document, which is exactly what FACA requires. I did not ask for the document to be emailed to me nor for it to be posted on the CFSAC website. I also never claimed that the FACA violation was the result of the failure to do so. Yet with her above statements, Dr. Lee falsely insinuated that I did when, in fact, I pointed out a FACA violation resulting from not making the document available to the public at all as required by FACA.

Regarding her second argument, Dr. Lee seems to be confusing the Freedom of Information Act (“FOIA”) and FACA. Under FOIA exemption 5, government agencies may withhold documents that are the product of the “deliberative process in governmental decision-making,” also referred to as “pre-decisional,” the term Dr. Lee used. The relevant FACA-disclosure requirements, however, are as follows:

“… FACA requires disclosure of written advisory committee documents, including predecisional materials, such as drafts, working papers and studies. The disclosure exemption available to agencies under exemption 5 of FOIA for predecisional documents and other privileged materials is narrowly limited in the context of FACA to privileged ‘inter-agency or intra-agency’ documents prepared by an agency and transmitted to an advisory committee.” [emphasis added] (Memorandum Opinion for the Assistant Attorney General Office of Legal Policy dated April 29, 1988)

In other words,

“FOIA Exemption 5 cannot be used to withhold documents reflecting an advisory committee’s internal deliberations.” (Memorandum for Committee Management Officers from James L. Dean, Director, Committee Management Secretariat, dated March 14, 2000)

The rationale is simple:

“Timely access to advisory committee records is an important element of the public access requirements of the Act. Section 10(b) of the Act provides for the contemporaneous availability of advisory committee records that, when taken in conjunction with the ability to attend committee meetings, provide a meaningful opportunity to comprehend fully the work undertaken by the advisory committee.” (see 41 C.F.R. §102-3.170)

CFSAC, as a FACA committee, is not an agency. Therefore, there is no FACA exemption for pre-decisional materials prepared within CFSAC, a sub-committee or a working group for consideration at a CFSAC meeting. Such an exemption would apply only if the materials were prepared by HHS, one of its component agencies or another federal agency.

Lastly, with respect to the working group draft documents that were discussed during the August 18-19, 2015 meeting, Dr. Lee mentioned they were “in the back of the room” and “available for anybody here for review.”

That would not appear to be FACA-compliant either because under Section 10(b) of FACA, the documents “shall be available for public inspection and copying ….” In order to gain access to a CFSAC meeting, one must be pre-registered for the meeting in order to undergo a security check in advance. Without being registered, one is not able to enter the Hubert H. Humphrey Building where the meetings take place. Therefore, “available for anybody here in the room” does not constitute being “available for public inspection” and “available for review” does not satisfy the requirement that it be “available for copying.”

In my last post, I called for a firm commitment from HHS to follow federal laws, such as FACA, going forward. Instead, Dr. Lee misinformed the committee and the public about the legal requirements under the statute, implying that no FACA violation by HHS had occurred. HHS continues to act as though the agency is above the law and it appears that HHS has no intention to be compliant in the future.

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Oops, they did it again! CFSAC violates FACA

This is a post about the violation of federal law by CFSAC yet again. This is also a post about how HHS has controlled CFSAC’s input on the P2P report.

CFSAC violated FACA, the Federal Advisory Committee Act, again. Not that anybody is shocked by that anymore, I know. Just your typical day at the CFSAC office. But wait! There is more. CFSAC’s DFO unduly influenced the committee’s advice to the Secretary. While this probably doesn’t come as a surprise to most either, it is quite revealing as to the mindset of HHS and what M.E. patients can expect from the agency, which is more stonewalling and empty promises. Nothing good has ever come out of that agency for us. I hate to be the bearer of bad news, but it’s not about to change if history as recent as January of this year is any indication.

“How dare I make these claims!” you say? Well, CFSAC admitted to the FACA violation in writing (see below) and I will spell out the overwhelming evidence for the undue influence of CFSAC by HHS in detail below. Here is a link to supporting documents for both, which I received in March 2015 from HHS after I officially requested, under FACA, documents relating to the January 2015 CFSAC meeting.

Of course, the same document-production game was played that HHS enjoys so much with FOIA requests, except, this time, they could not delay as much as they do with FOIA requests (Never mind that it violates federal law.) because I formally requested the documents under FACA and the deadline for bringing a lawsuit based on a FACA violation is very short. There are more technicalities here, but I will spare you the tedious details. I received the documents shortly before the deadline to sue for this recent FACA violation. Part of the documents—crucial parts, i.e., the reference to the line-item numbers for the P2P draft report—are illegible; pages were out of order based on the Bates numbers assigned to them by HHS; and after I sorted them according to the Bates numbers, they were not in chronological order. Maybe to make up for that, I received duplicates of 45 pages. Of course, all of that makes a review that much harder, but based on my FOIA lawsuit experience with HHS and NIH, it’s not only par for the course, it’s by design.

Page numbers I cite refer to document page numbers, not the Bates numbers at the bottom. If you are in the document on your computer, searching for a page is much easier that way. However, if you print the document (It’s long!), the page numbers will be off by one because the cover letter from the DFO does not have a Bates number.

No Access for Public to CFSAC P2P Draft Comments During January Meeting

FACA, the Federal Advisory Committee Act, governs the activities of federal advisory committees. Unlike with, say, the Patriot Act, the title sort of gives it away. Importantly here, it focuses in part on meetings being open to the public. According to section 10(b) of FACA, an agency is generally obligated to make available to the public, before or at the time of the meeting, all materials that were made available to or prepared for or by an advisory committee. The rationale for the obligation to provide contemporaneous availability of advisory committee records under FACA is simple. It is to afford, “when taken in conjunction with the ability to attend committee meetings, […] meaningful opportunity for the public to fully comprehend the work undertaken by the committee.” (41 C.F.R. §102-3.170). Without that opportunity, the meeting isn’t really open to the public. Not providing contemporaneous access to committee records is a FACA violation, a big federal no-no, and that’s what happened with CFSAC in January of this year.

So, “What exactly happened?” you ask. At its December meeting, CFSAC decided to convene an ad hoc working group (“Working Group”) that would provide comments from CFSAC on NIH’s Pathways to Prevention (“P2P”) draft report. The Working Group consisted of the following CFSAC members and ex officios: Dr. Dane Cook, Dr. Mary Ann Fletcher, Dr. Fred Friedberg, Dr. Susan Levine, Dr. Janet Maynard, Donna Pearson and Alaine Perry. The Working Group also included two non-CFSAC members, Claudia Goodell and Charmian Proskauer. That Working Group prepared a draft of the official CFSAC comments on the P2P report and that draft document was the subject of discussion among all CFSAC members at the January 2015 CFSAC meeting. (It was finalized after the meeting and submitted to the Secretary.) FACA was violated when the discussed draft was not made available to the public prior to, or at the time of, the meeting. As a result, patients and other members of the public who listened to the meeting over the phone—the only way for the public to participate—found it impossible to follow along, which essentially turned the meeting into a non-public meeting and that, in turn, means that the CFSAC P2P recommendation to the Secretary was invalid.

There is not much grey zone here. This is about as clear-cut a FACA violation as you will find. If you still don’t believe me, check out page 1 of the linked-to documents. And I quote from a letter written to me by the DFO, Barbara James, dated March 3, 2015, in response to my FACA demands:

“We sincerely apologize that the enclosed Draft Comments discussed during the CFSAC meeting on January 13, 2015, were not provided at the time of that meeting. Thank you for bringing this issue to the attention of HHS, so that HHS can try to prevent this issue in the future.”

And there you have it. Excuse me if I find the I-swear-I-didn’t-know-FACA explanation lacking. Assuming that CFSAC’s DFO was indeed ignorant with respect to FACA, is that really better than a willful violation? I any event, it is an assumption I am not willing to make. The DFO is supported by an assistant whose job it is to know the intricacies of FACA inside and out. This was no oversight.

Also note the lack of a firm commitment to comply going forward. “[T]ry[ing] to prevent [FACA violations] in the future” just isn’t anywhere near good enough.

HHS was fully aware that not providing the draft comments to the public in time for the meeting would make it impossible for the public to follow the meeting. When asked by Ms. Perry about the reason for the artificial three-page limit for the CFSAC comments, the DFO replied that there isn’t an official page limitation (page 305) and then stated the following (page 304):

“The upcoming meeting will be a conference so the committee and the public will not be viewing slides or the document on their computers. Therefore, all changes (edits, new text, etc.) will not be visible to the listening audience or the committee.”

This statement is true only with respect to the public, of course. The committee, on the other hand, did have access to the document, either on their computers or in hard copy format (though not to the changes in real time other than by listening). But what’s important here is that it didn’t bother the DFO one bit that the public would basically be shut out of a meeting that, under federal law, is supposed to be open. Ms. Pearson was also aware of the lack of access to the document to be discussed (p.89):

“Since the public will not have the document, you should suggest up front that they follow along using the P2P’s 389 line Draft Executive Summary if possible. (You might also say that it might probably be difficult for them to follow everything discussed, but that the complete document should be posted on the CFSAC website after going through the correct channels.)”

A cognitively impaired patient population will have difficulty following the discussion of a document it doesn’t have access to? You don’t say! This complete disregard of the duties of a DFO under a federal law is simply inexcusable. Which part of “contemporaneous” is so hard to grasp? What good does a subsequent posting of the finalized document do? None. And “after going to through the correct channels?” Wait, more censorship?

When I threatened legal action in January, I received the linked documents, among them various versions of the draft CFSAC comments. But again, having access to the discussed document after the meeting is not what Congress had in mind when it enacted FACA.

And how about this? In an earlier comment regarding the three-page limit of the document, the DFO offered this justification (page 305):

“… to increase the chances that NIH will actually review and consider our comments.”

This had me quite confused, as the P2P process was supposed to be carried out completely independently from NIH. But I digress.

Keep in mind that CFSAC is required to provide the committee documents without members of the public requesting them. And yet, HHS did not do so despite many patients and advocates expressly asking for it. See the numerous emails from the public in the public-comment section of the linked documents starting at page 150 asking for a copy of the draft comments.

[Edit August 20, 2015: At the CFSAC meeting on Tuesday 18, 2015, the DFO, Dr. Nancy Lee, seemed to try and counter my charge of this FACA violation. I examined her arguments in my new blog post, “Another CFSAC FACA Fail: DFO Misconstrues Law.” Basically, Dr. Lee misinformed the committee and the public on the law.]

Undue Influence by HHS

Regarding the second violation, let’s start with how those P2P comments from CFSAC came about. Please note that I have probably not completely captured the process, as it seems pretty clear that I was not provided with all correspondence regarding the matter, despite the representation by HHS that it had “provided all the documents available under FOIA.” Another blatant misrepresentation.

On December 19, 2014, Ms. Pearson sent a first draft of the CFSAC P2P comments to the Working Group (pp. 277-298). A call among the Working Group members was had on January 5, 2015 to discuss the draft and a revised version was circulated the same day. Three days later, another version was sent to the Working Group members.

Ms. Pearson rejoiced:

“The end is in sight!”

Quite obviously, the Working Group did not expect any substantial additional changes (aside from the ones from CFSAC members who were not part of the Working Group).

Ms. Pearson let the Working Group members know that the document was:

“being carefully reviewed by Barbara James and her staff. They will check for grammar, typos, errors.” They would then “send the document to the full Committee for advance review.” (p. 2)

So far, so good. Grammar and typos, fair enough. Errors, makes sense. Until … all hell broke loose two hours later. Ms. Pearson notified the Working Group as follows (p. 29):

“Barbara James just informed me that the Committee Management Officer for HHS has advised that our document will not be cleared for submission to the Secretary as written. The inclusion of statements that are perceived to be inflammatory, negative or derogatory to HHS or other agencies, the Panel, the Secretary or others will not be accepted.” [emphasis added]

This beyond-belief interference by HHS reminds me a bit of lower-level party officials not allowing the submission to the Politbüro of a report  that will be offensive to the communist party or its leadership. Under FACA, CFSAC is supposed to be independent from its parent agency, HHS. In fact, it is supposed to give advice to HHS, not receive it from HHS just to turn around and forward it to the Secretary. It’s called an “advisory committee!” Get it? If HHS dictates what advice CFSAC can give to the Secretary, then the Secretary is really advising herself through her own agency. Go, taxpayer money!

The Secretary is, of course, free not to implement a CFSAC recommendation. In fact, HHS’s Secretaries have a lot of experience with that; they have made a habit out of ignoring CFSAC. But HHS’s Committee Management Officer or CFSAC’s DFO have no right to refuse to submit a CFSAC recommendation to the Secretary. The draft comments disseminated to the Working Group were about to become a CFSAC recommendation subject to some minor changes by the entire CFSAC before and during the January meeting had the DFO not intervened. To threaten that a committee recommendation will “not be cleared for submission to the Secretary as written” clearly eviscerates CFSAC’s independence.

There was a certain amount of CYA involved here (p. 29):

“Please be aware that Barbara did indicate that we can stand by our original document and/or that one or more of us could submit it directly to the P2P Panel as individuals (not on behalf of the CFSAC). However, it will not be posted on the CFSAC website without the Secretary’s clearance, nor it will be sent to the Panel.”

Another threat, this time that HHS would not post the recommendation on the CFSAC website. HHS must really not have liked those nearly complete draft comments by the Working Group.

So, let’s look at this more closely. Subjectively (“perceived”) inflammatory, negative or derogatory comments will not even be sent to the Secretary? Nothing “negative?” Are these people serious? What is this, the editorial policy of Pravda? If a Secretary’s ego is so fragile that she can’t handle any criticism of anybody (“others”), maybe she’s in the wrong line of work. Patients are suffering day in and day out and the highest-ranking government official in the health department needs to be protected from the truth? Why is it that HHS is so ashamed of the M.E. reality that they have created? If they had done their jobs, shouldn’t they be proud?

But fear not, Ms. Pearson promised an easy fix of the situation. She let the Working Group know that the DFO volunteered to work late into the night to sanitize, I mean revise, the document (page 29). And so the DFO did; she worked all the way till 11:22pm, bless her heart.

This did not go over very well with some of the Working Group members. This is what Dr. Fletcher had to say in reply to the astounding news (p. 31):

“I am certain that our charge as members of the CFSAC was to advise the Secretary of HHS on ways the HHS may better help patients with ME/CFS through research, clinical care and prevention efforts. We were not told to avoid criticism of the HHS or any of its agencies, indeed we were to advise HHS and advise on ways to have an effective programmatic response. The P2P process, which included public response time before finalizing was designed to help set the research agenda for the field. Certainly the CFSAC advisory committee’s response should have weight and be taken into account. The report as it stands is the advise [sic] of this committee to the Secretary and the P2P panel. It should not be edited or changed by the HHS staff.

We thought that we were asked to serve on CFSAC because we had expertise in the field and that HHS wanted our advice. We have worked diligently and professionally in preparing this response, which should be delivered to Secretary and to the P2P panel without further changes or delay. We would hope our comments will be seen and influence the report before it is finalized.”

Brava, Dr. Fletcher!

Ms. Proskauer also took issue:

“Barbara, can you tell us exactly which statements have been flagged as ‘inflammatory, negative or derogatory?’ We should all know, then be given the opportunity to address these as a group. The full Committee has not even had an opportunity to review our work, either to approve or change. It does not seem appropriate to be making changes prior to the full Committee discussion.”

More good points made.

Despite objections being raised, the DFO proceeded to revise the document and, man, it sure must have been in need of some serious revisions— given the massive amount of changes that were made— despite all the time and effort the Working Group had invested and despite the fact that the draft was basically final. In the process of being reviewed and revised by HHS, entire paragraphs were deleted. In order to get a feel for the extent of the revisions that were made after HHS got involved, take a look at the redlines starting on p. 33 and on page 359. Some language was revised in such a way as to change its meaning completely. The redlines don’t always seem to properly track the changes that were made because the deletions and additions don’t match up in some places. Some changes didn’t make it into the final document. The important point is the extent of HHS’s involvement and the nature of the resulting or attempted changes. The comments were supposed to come from CFSAC, not HHS itself.

As you go through the versions and email correspondence, please keep in mind that there are, in all likelihood, many emails missing. Some emails are referenced, but were not provided. Not a single email critical of the HHS draft was provided to me. It is simply not credible that there were none. There is no way that there was not more fallout from the vast changes made after HHS got involved. Some Working Group members did not chime in at all if one were to believe the file I received is complete. Obviously, there is a lot more related correspondence out there that we don’t have access to. Are we to believe that somebody as principled and outspoken as Dr. Fletcher, for example, would not have objected to the heavy-handedly edited Working Group draft? The correspondence that was sent to me was clearly cherry-picked and the critical voices were left out. Dr. Cook called the revised document “improved” (p. 84). Seriously? The document was gutted! With friends like that, who needs HHS? Dr. Sue Levine simply said, “I think the document is fine.” And off it went to the entire committee, sent by the DFO. A few more changes were made in response to requests by the full committee. And voila, a CFSAC recommendation that was quite different from what the Working Group had signed off on was created. It can be found on the CFSAC website.

Below are a few examples of changes that seemed to have occurred after HHS got involved. There are many more. Underlined parts were added. Struck-through parts were deleted.

“Although dedicated researchers have identified parameters for defining ME/CFS, those parameters have not been universally adopted by the CDC and HHS. As a result, studies of ME/CFS are fraught with methodological problems, preventing a clear understanding of who is affected by the disease.” (p. 10)

“The dissemination of diagnostic and therapeutic recommendations should focus on primary care providers and all other health care providers dealing with symptoms specific to this disease, including but not limited to cardiologists, endocrinologists, neurologists, rheumatologists, psychiatrists, clinical immunologists, internal medicine and pediatrics, and infectious disease specialists.” (p.15) (emphasis added)

Earlier in the Draft, you asked whether or not ME/CFS is a spectrum disease. We believe the better question is the one originally published by the PzP Working Group and then discarded due to lack of research studies and evidence. “Are ME and CFS separate diseases or do they fall on a spectrum of one disease?” To take that original question further, have the terms CFS and ME/CFS been broadened, intentionally or otherwise, to encompass far more conditions than the disease identified as Myalgic Encephalomyelitis by the World Health Organization? ” (p. 18)

Researchers, advocates and the CFSAC have recommended use of the Canadian Consensus Criteria to define the illness until further research warrants modification. The failure to do so, along with the failure to adequately fund large scale studies aimed at identifying objective biomarkers, has opened the door to no fewer than eight (8) definitions over the years.” (p. 35)

The dearth of funding and reluctance of the HHS to collaborate with the broader stakeholder community has negatively impacted scientific progress in every way.” (p. 36)

“…estimated $5 million, which is far below diseases of less consequence and lower prevalence…” (p. 36)

Clinicians and others who do not think that ME/CFS is a disease in its own right simply have no read the literature and are thus uninformed.” (p. 40)

Yet the NIH and other agencies use a lack of information regarding ME/CFS to justify the failure to adequately fund additional research. In a response to this Committee’s request for an RFA in 2014, the National Institutes of Health replied “Unfortunately there remains a lack of definitive evidence regarding the etiology, diagnosis, and treatment for ME/CFS. As such, issuing a Request for Applications (RFA) would not be an effective strategy as RFAs generally encourage a narrowly defined research area that addresses more specific gaps in scientific knowledge.” Regarding the lack of a consistent set of criteria, the CFSAC has frequently recommended the universal adoption of the 2003 Canadian Consensus Criteria (CCC), requiring the key symptom of post exertional malaise.” (p. 40)

It is important to acknowledge that a majority of experts in the field have agreed upon parameters for defining ME/CFS. In a letter to the Secretary of Health and Human Services dates September 13, 2013, more than 50 of the world’s experts stated that they support the adoption of the 2003 Canadian Consensus Criteria and urged the HHS to adopt the CCC as the single case definition for all Department activities, both research and clinical uses. The NIH acknowledged their status as experts when responding to a CFSAC request for a data and biobank sharing platform in 2014: “The pool of ME/CFS researchers is small (e.g., the advocacy field identifies a group of 50 ME/CFS clinicians and scientists world-wide considered expert in this area of research.)… Thus, developing and maintaining a unique ME/CFS database is cost prohibitive in light of the small number of ME/CFS researchers…” However, the request of these experts to adopt the 2003 Canadian Consensus Definition has not been recognized or supported by the CDC and HHS agencies.” (p. 40)

“... we consider the PACE Trial to be “fruits of the poisonous tree.” (p. 43)

There is research and evidence for post-exertional malaise in ME/CFS and neurocognitive symptoms have been demonstrated for decades in this patient population. Much of the literature regarding ME/CFS was excluded from the Evidence Review.” (p. 45)

“[T]he failure to lack of universally accepted adopt the parameters identified by dedicated researchers has stifled progress.” (p. 45)

“There exists a plethora of is published objective data about ME/CFS and the disease itself is not subjective in nature.” (p. 45)

Additionally, rather than holding yet another workshop or conference, strong commitment from the Department of Health and Human Services is needed to follow the lead of experts in the field and fund the research that is so desperately needed.” (p. 46)

The Department of Health and Human Services HHS should follow the lead of stakeholders and national and international experts to adopt a universal consensus-based case definition and to help advance the field.” (p. 46)

For decades the burden of communication has fallen almost entirely on patients who must often educate themselves in order to receive a correct diagnosis, and then must educate family, friends, employers and healthcare providers.Many patients, especially those who are better educated and have more financial resources, are (by necessity) actively involved in their own care, while others are too sick to participate or do the research required to find physicians who can help.” (p. 50)

The DFO delivered her vast edits with the following comments (p. 358):

“I tried to keep as much of the working group’s language as possible.”

Could have fooled me. And not just me. Even Ms. Pearson, who was spearheading the Working Group effort and worked very closely with the DFO, noted (p. 62):

“We will need to communicate thoroughly and effectively with the members of the Working Group. There are so many modifications this document [sic] that they will consider the revisions to be disrespectful of their expertise and unappreciative of their contributions.”

When Ms. Pearson sent the heavily revised document to the Working Group, she did so saying (p. 88):

“PS If you are interested in seeing Barbara’s ‘red ink’ version, I will send it under separate cover. However, you’ll probably see all the deletions and changes and get confused, disheartened, and angry. So I just ask that you check out the revised document with a fresh eye first, then go through the marked up version to see specifically what is [sic] missing and/or changed.”

These two quotes are ever so revealing. It is quite obvious from that language that there was an awareness that the extent of the changes was excessive and problematic.

Remember, the document was just about to go to from the Working Group, which had basically completed its work, to the entire committee for their review when the DFO, Barbara James, took over. (The remainder of the committee later ended up making only minor changes to the document, as those committee members with the most interest in the subject had likely volunteered to be members of the Working Group and had already provided their input.) The only changes that the DFO and her team were going to make were with respect to grammar, typos and errors. Yeah, right.

I noticed that Dr. Levine raised the necessity of separating ME from CFS twice, but no responses to her have been produced. Here are Dr. Levine’s remarks:

“I wonder if any of you care to address the ambiguity of using the combined term ‘ME/CFS’ and the need to tear these apart as representing possibly 2 separate illnesses.” (p. 300).

“Personally, I feel that even though it’s mentioned several times, that it’s crucial that we distinguish ‘ME’ as a separate illness or what we now understand to include ‘post exertional malaise’ from other types of fatigue.” (p. 313)

Finally, Ms. Pearson sent an email around to the Working Group copying and pasting “complimentary emails.” Emails by Working Group members that were critical of the process are obviously missing from the production (see above), but HHS was making sure to send along those messages containing praise, pitting different corners of the patient community against each other:

“Although no one told me their remarks were confidential, it might be best to keep them within out group, just in case.” (pp. 345-347)

Just in case of what? In case of a FOIA request, in which case the identities cannot be legally redacted? Although assuming that HHS would bother with legalities is a stretch. Silly me. Some of the messages are easily attributed to their authors as it is. Let’s see, which advocate uses random initial caps, just for example? Of course, I noticed the mea-culpa message (p. 346):

“I thought Jeannette Burmeister was on to something with her legal case and that it was all well thought out. My sincere apology!” (p. 346)

I respect somebody who is able to admit they were wrong. Except I was indeed on to something and it was indeed all well thought out. No good deed goes unpunished.

So, am I going to get an apology now? No worries; my ego is not that fragile or needy. What really is called for is an apology by HHS to the entire M.E. community and, more importantly, a firm commitment to follow FACA and other federal rules in the future.

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CFSAC Comments August 2015: Ampligen Price Increase on Shaky Ground

I looked into the Ampligen issue–the exorbitant 267% price increase by Hemispherx–some more. Here is one thing that patients who are currently enrolled in the trial can do. They can contact Schulman Associates, the Institutional Review Board (IRB) for this trial at: Schulman Associates Institutional Review Board, Inc., 4445 Lake Forest Drive, Suite 300, Cincinnati, Ohio, fax: 866.377.3359. The IRB was “established to help protect the rights of research subjects” and encourages trial participants to write to the IRB “[i]f [they] have any questions about [their] rights as a research subject, and/or concerns or complaints regarding this research study….”

I also sent a follow-up message to FDA’s Dr. Woodcock with additional information regarding the distressing new price for Ampligen. I submitted that message together with my message to Dr. Woodcock from two days ago as official comments for the CFSAC meeting next week urging CFSAC, especially its FDA ex officios, to follow up with Dr. Woodcok. My CFSAC comments are reproduced below. (My new message to Dr. Woodcock starts under “August 13, 2015 Letter.”)

CFSAC Meeting August 18th-19th, 2015

Public Comments by Jeannette Burmeister

Submitted on August 13, 2015

I would like to urge CFSAC, particularly its FDA ex officio members, Drs. Maynard and Hall, to follow up with Dr. Woodcock regarding Hemispherx’s enormous price increase for Ampligen. Since FDA has regulatory authority over cost-recovery programs such as the Ampligen trial, I am asking that FDA exercise its authority to audit the justification of the new price and to re-assess its authorization of the increased price.

Below are two letters I sent to Dr. Woodcock on August 11, 2015 and today (August 13, 2015) with more details about the situation, which is dire and urgent.

August 11, 2015 Letter:

You can read my August 11 letter at 267% Price Increase for Ampligen.

August 13, 2015 Letter:

Dear Dr. Woodcock,

As a follow-up to my letter of August 11, 2015 regarding the enormous price increase for Ampligen by Hemispherx Biopharma, Inc. (“HEB”), I wish to raise a few additional issues.

As you know, FDA may allow drug companies to recover certain costs for investigational drugs in accordance with 21 C.F.R. 312.8, as it has done in the case of HEB and Ampligen. In order for a drug manufacturer, a so-called sponsor, to charge for certain costs for a drug undergoing clinical investigation, certain requirements have to be met.

In accordance with 21 C.F.R. 321.8(d)(1), a sponsor may recover only the direct costs of making its investigational drug available, not the indirect costs. The regulations further provide:

“Direct costs are costs incurred by a sponsor that can be specifically and exclusively attributed to providing the drug for the investigational use for which FDA has authorized cost recovery.“

“Indirect costs include costs incurred primarily to produce the drug for commercial sale (e.g., costs for facilities and equipment used to manufacture the supply of investigational drug, but that are primarily intended to produce large quantities of drug for eventual commercial sale) and research and development, administrative, labor, or others costs that would be incurred even if the clinical trial or treatment use for which charging is authorized did not occur.”

In March of this year, Hemispherx announced the completion of an $8 million facility-enhancement project in New Brunswick, N.J. to allow for a higher-capacity manufacturing process for both Ampligen and the company’s other drug, Alferon N. In the same month, HEB announced plans to commence distribution of Ampligen in Australia and New Zealand. This week, HEB announced that it was getting ready to supply Ampligen to patients in Europe and Turkey. As Australia, New Zealand, Europe and Turkey are currently completely untapped markets for Ampligen, it seems likely that the upgrades to the New Brunswick facility were made in anticipation of commercially selling the drug in these large new distribution areas, especially given the timing; the completion of the enhanced facility nearly coincided with the announcement regarding Australia and New Zealand and was followed, only a few months later, by the announcement with respect to Europe and Turkey. HEB will need to produce Ampligen in much larger quantities now in order to satisfy the demand in the new markets and with its upgraded facility will have the capacity to do so. In addition, HEB, by its own admission, is still actively and diligently pursuing FDA approval in the U.S. If it is successful with that endeavor, the new facility will be used to produce large quantities of Ampligen for commercial sale in the U.S. Consequently, the facility-enhancement project is likely an indirect cost and not recoverable under FDA regulations. Therefore, should HEB have included it in the cost justification for the price increase in the U.S. market, that would constitute an improper cost calculation and, given the magnitude of the project, even if depreciated or amortized, it alone may account for the Ampligen price increase.

Moreover, HEB has incurred manufacturing costs for the study of Ampligen treatment of other indications, e.g., Ebola, HPV, HIV, hepatitis and influenza. Were the costs for those efforts included in the cost justification for the open-label-trial price increase?

I also want to make you aware of the fact that the documentation that patients had to sign in order to enter the trial makes the express representation that the charge for the drug is “expected to be $2,100 for the first eight (8) weeks and $2,400 for each additional eight (8) week period.” Obviously, modest, justifiable price increases are to be expected and not objectionable. Dramatic increases—certainly those in the ballpark of 267% (an increase of $26,000 per year, from $15,600 to $41,600)—are not; they are inconsistent with the terms on which patients agreed to participate in the trial. In an FDA-regulated trial, such seeming price gouging ought to be impermissible, especially given the concerns as to the cost calculation and the representations made to the participants in the trial, many, if not most, of whom have made substantial personal sacrifices, financial and other, to participate and have also, over all these years made contributions, often at a price to their health, to HEB’s FDA-approval efforts for Ampligen by frequently completing extensive paperwork, undergoing large blood draws, performing stress tests twice a year, traveling to D.C. to testify in support of the approval of the drug, etc.

These and potentially other concerns raise serious questions as to whether the tremendous price increase for Ampligen was implemented properly and is otherwise permissible. Since FDA has regulatory authority over cost-recovery programs such as this one, I am asking again that FDA exercise its authority to audit the justification of the new price and to re-assess its authorization of the increased price. I do not purport to speak for anybody other than myself, but please be aware that the situation is a top priority for many in the patient population.


Jeannette Burmeister


Dr. Stephen Ostroff, FDA Acting Commissioner (via email)

Nancy McGrory, Hemispherx Patient Advocate (via email)

Schulman Associates Institutional Review Boards (via fax)

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267% Price Increase for Ampligen

[Please see here for my follow-up letter to Dr. Woodcock.]

I just sent the following message regarding Hemispherx’s extraordinary 267% price increase for Ampligen to Dr. Janet Woodcock, the FDA’s Director of the Center for Drug Evaluation and Research:

Dear Dr. Woodcock,

I am writing to you regarding a matter of grave concern for the patients in Hemispherx Biopharma, Inc.’s (“HEB”) AMP-511 open-label clinical trial for Ampligen, a drug highly effective for many ME (or as the FDA calls it “ME/CFS”) patients. I have testified at the Ampligen Advisory Committee meeting and other federal committee meetings in favor of FDA approval of the drug and I remain convinced that this drug should be approved by the FDA without further delay because many patients would benefit from it and because there are no other FDA-approved pharmaceutical interventions for ME.

I have been a study participant for over three years. Last night, I learned through ME Action’s blog (http://www.meaction.net/2015/08/10/ampligen-price-increases-substantially-available-soon-in-europe/) that the price of the drug will go up 267%, from $15,600 to $41,600 per year, effective immediately as of July 24, 2015. Because it has not been approved by the FDA, the cost of the drug is currently not covered by private insurance or Medicare/Medicaid. Patients pay the entire cost out of pocket. Nevertheless, I have not received any notification from HEB of this extraordinary price increase.

HEB seems to claim that the price increase is necessitated by their increased cost in providing the drug to trial participants and that the increase has been verified by an accounting firm. However, accounting firms can avail themselves of a number of different methods to establish cost. For example, I understand that HEB recently expanded its facilities. Was the cost of this expansion, which would be a sunk cost at this point, included in the cost justification for the price increase either through depreciation or amortization? Moreover, HEB’s position itself is apparently contradictory as to the basic fact whether the new price includes merely manufacturing cost or also the cost of continued research and FDA-approval efforts. These points are merely illustrative of the various types of cost that may or may not have been included in the price-increase justification. It just does not seem probable that HEB’s cost increased that dramatically over night. A gradual increase seems much more plausible and would have been much easier to absorb for patients.

As you know, there are only four Ampligen trial sites in the country. Patients move and either leave their families behind or uproot them, either buy and sell houses or rent second homes, give up or change jobs, mortgage their houses, enroll their kids in new schools, etc. in order to relocate to a trial site and, in doing so, incur substantial long-term expenses far beyond just the price of the drug and the related infusion/physician’s cost. At the very least, HEB could have informed study participants of the fact that it is considering an increase at the time when it hired the accounting firm. The entire process from hiring the firm to the firm’s completed report typically takes time. That would have at least provided patients some advance notice. Some patients have very recently invested in relocating to a trial site just to find out now that they will not be able to afford the drug at the new price.

To be completely blindsided, not only without any advance warning, which was entirely feasible, but without any notification from HEB whatsoever upon effectiveness of the increase—more than two and a half weeks ago—is inexcusable and I would like to confirm with you that HEB followed any applicable federal rules both with respect to the magnitude of the price increase and the lack of notice.

I am looking forward to your response. Obviously, the matter is of utmost urgency, as many trial participants will be unable to afford the new price and will have to re-plan their lives without the drug. Most importantly, suddenly being cut off from a potent drug that patients’ immune systems have come to rely on might very well put the health of the current trial participants at risk.


Jeannette Burmeister


Dr. Stephen Ostroff, FDA Acting Commissioner

Nancy McGrory, Hemispherx Patient Advocate

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Hip Surgery and ME: Society Has It Wrong

I am proud to share a note that my husband, Ed Burmeister, wrote last week. He initially posted it on Facebook only where it received a lot of attention and was shared more than 250 times. It really resonated with the community.

Therefore, I talked him into allowing me to post it here as well. I am blessed to have such a supportive and loving spouse.

Last Wednesday, I had a complete hip replacement.  It was a short procedure (1-1/2hours). No general anesthesia required.  I was out of bed the day of surgery and home after two days.  On Monday, I started driving again and really could have done so on Saturday already. Yesterday, I returned to work. I was comfortably working away, largely free of pain.  I walk without a limp and with no assistance and am pretty much unrestricted in my activities. I never needed narcotic painkillers after the surgery.  Ibuprofen does the trick.

Well-wishing family, friends and colleagues sent cards, flowers and gift baskets.  These were all nice to receive and I appreciated them. There have also been numerous and repeated inquiries about my progress. Just a lot of thoughtfulness all week.

Contrast this with the way Jeannette and her fellow ME patients are viewed and treated by the same cohorts.  Their disease, myalgic encephalomyelitis, is many multiple times worse than what I went through and it is ongoing, in Jeannette’s case for over nine years now. Many others have been sick much longer, some for decades. ME patients will most likely be sick for life and they are typically getting worse, as ME is often progressive.

Most activities that others don’t think twice about are impossible for Jeannette. She cannot stand for more than just a few minutes. She cannot walk more than just a few blocks. Sometimes, she cannot walk one block. Her debilitation goes far beyond the effects on her mobility and reaches into every corner of our lives. She is never comfortable, not even for a few minutes. It is always just a matter of degree of the relentless misery. Jeannette’s only contact to the outside world, besides the infusion room, is Facebook. But her presence on social media is frequently judged by some (what her friend Dave, also an ME patient, calls) normal-health people. It is estimated that about 25% of ME patients are sicker than Jeannette, some to a point that is unimaginable to everybody who has not been around those who are near death.

Jeannette is unable to leave the house on most days, and then generally only to receive thrice-weekly infusions, and spends most of her time lying down. Even sitting is impossible for extended periods. If she ignores her limits, it comes at a big price in the form of feeling considerably worse. Last Wednesday, the day of my surgery, Jeannette had no choice but to sit in the hospital waiting room for hours. There was no way to elevate her legs, which would have helped somewhat. Her only alternative was to lie on the floor, which she has done at the airport and other places in the past, but couldn’t risk in a hospital due to her being immunocompromised. At the end of the day, she was at least as impaired as I was having just come out of major surgery. The next day, she was too sick to visit me in the hospital, for which she beat herself up. She wanted nothing more than to be there next to me in the recliner the hospital staff had kindly moved into my room to accommodate her disability. But she couldn’t. That day, she didn’t eat, she could hardly move or talk. It was her payback for the sin of being there for me on my day of surgery.

It breaks my heart to see what Jeannette and other ME patients go through every day of their lives due to being this sick. But something else is almost more intolerable and that is how society treats them.

The thing is, when she is able to go out to the doctor or for an occasional meal with me, Jeannette often looks normal, often fantastic actually, despite being quite sick because she rests up for her outings in order to be able to make them and she probably also operates on a fair amount of adrenaline when she does leave the house for which she pays dearly. There are times when her appearance matches her debilitation and she looks like death warmed over, but at those times, she is usually too sick to leave the house. Nobody sees it. When others see her on those better days, they simply cannot seem to take in the degree of suffering she endures on an ongoing basis.  It is as if, despite her achievements, she has no credibility with society, which makes split-second assumptions about her health merely due to her particular diagnosis and what people think they know about it, which typically has very little to do with reality. At best, her disability is ignored. At worst, she isn’t believed. Hence, she does not receive flowers or gift baskets or cards wishing her well. Much worse, she does not receive the consideration and understanding that even a modest comprehension of her disease should provide.

I think it is as hard on her as the suffering from the disease to have to endure this constant indifference and complete lack of understanding by those around her. The absence of any validation of the degree of her disability and of any consideration for her special needs is, in and of itself, debilitating and robs Jeannette’s soul of the nourishment and support she so desperately needs.

The determination with which society refuses to acknowledge the severity of ME would be hard for me to believe if I didn’t witness it almost daily. A week after major surgery, I am multiple degrees less sick than Jeannette is almost every day, but–except for her fellow patients from whom she fortunately draws a lot of strength–nobody around her knows it. Worse, it seems that people don’t want to know it.

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IOM’s Redefinition of ME: Farewell LTD Benefits, Hello Diluted Research Cohorts

In my last blog post, I attempted, based on my preliminary reading of the IOM report on ME/CFS, to flag a potentially crucial issue: that the report does not exclude, in its proposed clinical criteria, patients with primary or major psychiatric disorders present at the onset of ME. I did say that more analyzing of the situation is needed and after giving the issue more thought, here are some (but not all) additional considerations that I think ME patients should be aware of.

Long-Term Disability Benefits (LTD)

The LTD problem actually affects every ME patient that also has a mental-health issue, regardless of whether that was preexisting or developed later. This issue is much broader than that of pre-exising primary or major psychiatric disorders.

I’ll start with an anecdote for which it is important to understand that essentially every private long-term disability policy contains a mental/nervous limitation clause limiting benefits for disability caused by/due to, or contributed to by, a mental or nervous condition. Mental-health disability benefits are limited to two years; benefits for physical disabilities are usually to be paid until the age of 65 of the insured. The mental-health limitation clause is usually very broad. UNUM, for example, defines mental illness as “a mental, nervous or emotional disease or disorder of any type.”

When I came up on two years of disability, my disability carrier required that I undergo an independent medical exam (IME). I was asked to see a rheumatologist who explained to me that his specialty was the logical one in my case since fibromyalgia patients are seen by rheumatologists. According to him, fibromyalgia and chronic fatige syndrome are basically the same thing. So much for his expertise. The good doctor asked me a bunch of questions and asked me to perform certain tasks, such as standing on one foot and squeezing a device measuring my grip strength. At some point, he said something like, “You know, when my alarm goes off in the morning and I really don’t want to get up because I am tired, I do it anyway and after I shower and shave, I actually feel much better. You should try it. I am sure it would work for you.” Then he wrote a report diagnosing me with affective mood disorder because I “looked better” than he would have expected based on my list of “complaints.” Based on this rheumatologist’s “exam,” my disability insurance company denied future benefits as of the 2-year cut-off date for mental-health conditions. This rheumatologist had no psychiatric or psychological training or education and “examined” me for probably less than an hour and, yet, he diagnosed me with a mental-health condition despite the fact that my disability was based entirely on chronic fatigue syndrome. Like all other doctors who perform these IMEs, this was a physician who collects money from insurance companies for every IME he performs and whose likelihood of being assigned more IMEs surely goes up with every psychiatric diagnosis he makes. Of course, I appealed the decision and the insurance company ultimately, after a hard-fought battle on my part, reversed their opinion. It is well known that insurance companies do a risk-benefit analysis. How likely is the claimant going to sue? With me and my husband both being attorneys, they figured it was a losing battle for them. But how many other patients would have won that fight is anybody’s guess.

This happened while I had a diagnosis of CFS under Fukuda, which rules out the existence of any major depressive disorder—and that ultimately forced my insurance company to continue my benefits—and yet I had to fight a drawn-out battle designed to wear me down and make me give up my benefits. Come to think of it, it was very much like the strategy HHS and NIH have been using in my FOIA lawsuit. Fast forward to the IOM criteria. If they get implemented, disability insurance carriers will have a much easier time denying benefits. So far, all an ME patient really had to say was that he or she has a diagnosis of chronic fatigue syndrome and since that automatically ruled out any psychiatric disorders, insurance companies could not rely on the two-year cut-off as long as the CFS diagnosis was intact and could be proven to be justified. That doesn’t mean that CFS claimants haven’t been unjustly denied LTD benefits after two years with the pretext of the existence of a mental-health condition. In fact, it happens all the time in the case of CFS (and other disabling diseases). But with a good attorney and/or good medical records, the road to victory over unjustified denials was much less thorny.

Under the IOM criteria, a diagnosis of SEID does not prevent an insurance company from claiming the existence of a mental-health condition based on an IME. The only argument a patient will have under the IOM rules is, “No really, I don’t have any mental-health problems.” As opposed to, “Look, I have CFS. End of story.” And since there is a fair amount of secondary depression in this patient population and since most patients do not have the money or health for legal action, I can just see the number of denials and disability terminations skyrocket now. As the insurance companies have tried to pin the psych label on ME patients all along, this is highly likely to happen under the IOM criteria, either just based on the file if there is nay mention of any psychotherapy in there or based on an IME. The risk for any patient diagnosed with SEID is much higher than the risk for patients with other diseases because the insurance industry’s default argument, even under Fukuda, has always been that ME is all psychiatric. Imagine how much easier that position is to defend now under IOM, which officially lets SEID and psychiatric conditions coexist.

It is true that in order for disability insurance companies to be able to rely on the two-year cut-off, the mental-health condition has to be a contributing cause of the disability. So, theoretically, secondary depression, e.g., should not be an issue in the case of an SEID diagnosis as long as the disability would be present even without the secondary depression. But in the real world, insurance companies will rely on every dirty trick they can come up with and the IOM just handed them a perfect tool; insurance companies will look a lot more reasonable now in their unjustified denials. After all, it is pretty hard to prove that any potential mental-health condition is not a contributing cause of the disability. Again, many patients will not be able to fight for their rights in court and even if they are, it’s not unheard of to draw a judge who thinks that ME patients are just lazy and crazy. Case closed. The insurance industry’s odds just went way up.

It doesn’t matter one bit that the IOM stressed, during the rollout of the report, that this is a real disease that is not “the figment of patients’ imagination.” That was a nice sound bite for the public-release presentation of the IOM committee chair, Clayton. But that patient-placating language won’t mean a thing in the real insurance world, which will only focus on the hard and fast rules contained in the IOM criteria. All that will matter is that a mental-health diagnosis will be considered a contributing cause of the disability notwithstanding the diagnosis of SEID.

It had been rumored in the patient community that one reason for the IOM effort was to cut down on the liability ME patients pose for disability insurance companies. I had been wondering exactly how that would be achieved by the IOM. Now I know. It has always been a thorn in HHS’s and the insurance lobby’s eye that a Fukuda CFS diagnosis precludes certain major depressive disorders. The problem is now solved. I do not know what percentage of patients receive LTD. But it surely is not an insignificant number of patients.

The potential loss of LTD is a purely financial consequence for many patients. For the patient population’s future in terms of treatment prospects, the dilution of research cohorts (see below) is the crucial issue. But losing one’s LTD benefits is hardly trivial for many affected.

Anyway, the bottom line here is: Say goodbye to your long-term disability, folks. And thank the IOM for it.

Use of the IOM Criteria for Research

The charge of the IOM committee on redefining ME/CFS was to develop a clinical definition, not a research definition. Some have made the point that the definition standard should be more lax for clinical criteria (such as the IOM criteria) than for research criteria in terms of not excluding patients with pre-existing primary or major psychiatric disorders. And in an ideal world, I can see that. But the delineation of the two types of definitions is not that clear. Remember that Fukuda has been used for over 20 years to diagnose patients despite being a research definition only. The CCC and the ICC, clinical definitions just like the IOM criteria, have been used for research purposes, so it’s not a stretch at all to assume that the IOM criteria will be as well.

Also keep in mind that while the P2P’s original goal was to develop a new research definition, that objective has been changed by NIH to addressing the current state of research. So, there will be no new research definition coming out of the P2P process. If you further consider that Fukuda has been criticized for so long, then it is not hard to imagine that NIH will take the opportunity to start requiring IOM-criteria cohorts—which would permit the inclusion of patients with pre-existing primary or major psychiatric disorders—for any future research grants. The IOM plays straight into the hands of HHS, which has been psychologizing ME for so long. This aspect of the IOM report is a huge gift to HHS. According to Hillary Johnson (in her foreword to Heckenlively’s and Mikovits’s book “Plague”), a former NIH scientist, when asked how the agency feels about us, said not long ago, “They hate you.”* Now they have the means to really implement that hatred even more effectively.

This is not just speculation on my part about the potential use of the IOM criteria in research. Rather, despite its limited charge of addressing only the clinical criteria, the IOM has opened the door wide to using the new IOM criteria for research. Nancy Lee let that fact slip out during the CFSAC meeting in June of last year. And here it is, hot off the press from the IOM (page 225 of the IOM report):

“Future diagnostic research will be most instructive when protocols include patients identified using the committee’s proposed diagnostic criteria for ME/CFS ….”

There it is in black and white. The IOM recommends that their criteria be used for future research.

Diluting research cohorts will lead to more bogus science that will “prove” that ME patients are “only” psychiatrically sick. This does not help anybody, not patients with “only” ME and not patients with both ME and psychiatric disorders. If we don’t make any progress on the ME science front and, as a result, can’t get any effective ME treatments, patients with ME and pre-existing primary or major psychiatric disorders will not receive the help they need for their ME either.

While the absence of clean research cohorts has been a problem all along in many instances—although maybe rarely as extreme as with the PACE trial—inviting the use of criteria for US research that explicitly allow for the inclusion of patients with primary or major psychiatric disorders is a disaster for all ME patients whether or not they have a primary or major psychiatric disorder. But that’s exactly what the IOM has done. Without clean research cohorts, this patient population has very little chance of ever seeing any scientific breakthrough. I believe there is a real and not insignificant risk for that. This really is a dream come true for HHS (who paid for the IOM study), insurance companies and the Wessely school.

Solution for Pre-Existing Primary or Major Psychiatric Conditions?

People have asked me what my solution is for those patients who have a pre-existing primary or major psychiatric condition. Should they really be denied treatment for ME just because of their pre-existing psychiatric condition? The answer is that there is no easy solution. It is surely a horrible thing to suffer from a psychiatric disorder and then develop ME on top of it.

First of all, please keep in mind that excluding patients with existing primary or major psychiatric disorders is not something that I came up with. This has been the status quo for over 20 years. Fukuda excludes certain major depressive disorders, the CCC exclude primary psychiatric disorders, the revised CCC exclude certain depressive disorders and the ICC exclude primary psychiatric disorders.

It gives one pause that, out of the five definitions the IOM looked at (Fukuda, CCC and Revised CCC, NICE Guidelines and ICC), only one case definition didn’t contain an exclusion for pre-existing primary or major psychiatric disorders, the UK NICE Guidelines.

It has been argued that the CCC did not mean to prevent a diagnosis of ME in case of the presence of a primary psychiatric condition. The authors of the CCC, the argument goes, instead intended to make sure that patients receive medical care for the primary psychiatric conditions. I would agree with that interpretation to the extent that the CCC experts did indeed intend to ensure that patients get treated for “other active disease processes.” However, the CCC authors then clarified the prerequisites under which somebody with a primary psychiatric disorder can receive an ME/CFS diagnosis:

“If a potentially confounding medical condition is under control, then the diagnosis of ME/CFS can be entertained if patients meet the criteria otherwise.”

The only interpretation of this sentence that makes any sense at all is to exclude confounding conditions that are not “under control.” Again, this has been the rule; I am just pointing it out.

One potential solution that may or may not work, who knows, is to require patients with pre-existing primary or major psychiatric disorders to be treated to the point where they are asymptomatic with respect to their psychiatric condition (sort of along the lines of what the CCC is talking about). Let me use the example of thyroid disease again. If thyroid disease is successfully treated in a patient as evidenced by the lab results, but symptoms persist, then a physician ought to start thinking about an ME diagnosis if the ME criteria are satisfied because the thyroid doesn’t seem to be the only issue. The problem is that many, maybe most, competent endocrinologists look at the clinical picture as much as, if not more than, they do at the labs. And if a patient has ME, then that clinical picture looks as though the thyroid disease is not under control despite hormone replacement therapy because of the overlapping untreated ME symptoms. And round and round we go. This problem is even more complicated in the case of primary or major psychiatric disorders where no blood or other objective test exists. But I suppose it is possible to determine clinically, on a case-by-case basis, that a primary or major psychiatric disorder is under control due to treatment and in that case, maybe it’s appropriate to assign an SEID diagnosis as well.

Of course, this would not fix the research-cohort problem. But it may be a way to rule out diagnosing patients with SEID who really don’t have SEID. But can you imagine, in a time where financial constraints are putting more pressure than ever on doctors to get the patient out of the door quickly, that physicians will take the time to go to all that trouble? It’s just not going to happen in real life, unless you are seeing one of the dozen, or so, ME specialists. This holds true even more since the IOM in its report is discouraging physicians from running tests. The IOM further recommends that doctors who are brand new to the area with no prior knowledge on the subject matter will be making the diagnosis using the IOM criteria. These inexperienced physicians will therefore mainly rely on questionnaires and their untrained observations. I have no confidence at all that they will be able to accurately diagnose PEM or orthostatic intolerance, for example. As a result, it is inevitable that a good number of patients who do not have ME, but rather have a primary or major psychiatric disorder, would from now on fall under the definition that was previously the neuro-immune disease, ME. The combination of abandoning the exclusion for primary or major psychiatric disorders in combination with the failure to make any objective tests mandatory for an SEID diagnosis is a recipe for turning ME officially into a psychiatric condition in no time at all, which seems to have been HHS’s goal all along.

Had the government not successfully stonewalled almost every bit of scientific progress in the area, we would not be in this desperate situation because we would have made enough progress on having objective tests available that, unlike the cardiopulmonary exercise test and the tilt table test, can be safely used for the diagnosis of all patients, and the issue of diluted cohorts would be hugely mitigated.

Mental Health

After my last blog post, emotions were running high and I was painted by some as some intolerant, mental-health-patient hating, superior-acting, barely human being, although most comments were thoughtful and considerate.

Let me assure you that I have zero bias against mental-health patients. After I got sick with ME, I had plans to get my Ph.D. in psychology once I got well again. Not only did I never regain my health, I didn’t even make it through any of the prerequisite classes for a psychology program due to being sick with ME, but, for a while, I was definitely seeing myself as a future clinical psychologist with an office in downtown San Francisco. I know this throws a monkey wrench into the accusations made in response to my last blog. Although there are psychiatrists out there, especially in Europe, who have done tremendous harm to ME patients, the truth is that, if I had a psychiatric diagnosis and the recommended treatments were to help me, I would jump on it and wouldn’t care about the label.

So, I am asking people to hold comments that are along the lines of accusing me of a mental-health bias because what I am trying to do here is to point out an issue that is of crucial importance for ME patients and it’s not born out of any kind of prejudice on my part against the mentally ill. If you want to vilify me or misrepresent my position nevertheless, there really isn’t anything I can do about it. But the usual arguments brought up with people who belittle or stigmatize mental health are misdirected in my case and not helpful.

I realize that the topic of excluding patients with pre-existing major psychiatric disorders is a very sensitive and unpopular one and yet somebody has to bring it up. It’s pretty hard to argue the inevitable negative effects of the IOM’s failure to exclude primary or major psychiatric conditions on ME patients’ LTD benefits and on ME research. So, please don’t shoot the messenger; I didn’t make the rules. Attempting to shame me by mischaracterizing my arguments or by proclaiming I have a bias I do not have or ignoring the issue altogether is just not helpful.

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IOM’s Redefinition of Myalgic Encephalomyelitis Invites Over-Diagnosis and Risks Inclusion of Primary Psychiatric Disorders

Yesterday, the IOM finally—after almost 16 months that could have been used to diagnose patients using the CCC or ICC without wasting $1 million—released its report “Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness.” Please note that the copy you will find at the link above is still marked “PREPUBLICATION COPY—Uncorrected Proofs.”

I have not had a chance to analyze the entire document thoroughly, but I have taken a preliminary look at the section on comorbidities and also listened to the IOM rollout webcast for the report where comorbidites were addressed. The issue I am discussing here—psychiatric comorbidities—is so pivotal and potentially disastrous that I felt it necessary to flag it for the community right away. I will follow up with a more definitive examination of this absolutely crucial issue.

There may well also be issues with not excluding non-psychiatric conditions/diseases, but given the history of issues we’ve had due to conflation with psychiatry, I feel this is more urgent.

A few hours after the report’s release, Dr. Enlander posted the following on Facebook:

“These criteria would also allow the diagnosis to include psychiatric conditions that are specifically excluded by both the Fukuda and CCC. I am surprised that the experts in the IOM Oversight group has not commented on this.”

If Dr. Enlander is right—and he certainly seems to be—this would be a bombshell.

The CCC exclude “primary psychiatric disorders.” Fukuda excludes the “diagnosis of a major depressive disorder with psychotic or melancholic features.” As much as there is wrong with Fukuda, this is one point that definition got right.

During the rollout session, Dr. Clayton, the IOM committee chair, emphatically proclaimed that, under the new criteria, the existence of comorbidities does not preclude the diagnosis of SEID.

“Our attitude about this is that if they meet the criteria, the have SEID. If they have something else, then that diagnosis ought to be made and it ought to be treated, but that they should not preclude a diagnosis of SEID, unless the comorbid condition explains all the symptoms that the patient has.”

So, psychiatric diagnoses, such as depression, do not preclude a diagnosis under the IOM criteria. Let me explain below why this is a huge setback for ME patients. Of course, the problem is confounded by the fact that the IOM recommends that absolutely any physician can make the diagnosis. No specialty is required. Imagine a GP, instead of a specialist, making a diagnosis of multiple sclerosis or Parkinson’s. With the large number of ME patients and the small number of ME specialists, we do need more clinicians to provide care for ME patients. However, I feel that the IOM’s approach is going too far and is a recipe for over-diagnosing patients, especially in light of the fact that most physicians have had close to zero understanding of ME for decades. Given the failure to exclude psychiatric conditions whose symptoms often overlap with those of ME, there is a specific risk for including patients whose primary symptoms are actually psychiatric in nature.

Here is why failing to exclude primary psychiatric disorders is absurd and even dangerous. Yes, it makes sense to allow patients to have a concurrent diagnosis of, say, Hashimoto’s thyroiditis, something that is easily confirmed with a blood test. Psychiatric disorders do not have any objective tests, however.

Of course, a fair number of patients has other diseases and even secondary depression. With a disease like myalgic encephalomyelitis that steals just about everything from you, it’s not uncommon to develop secondary depression, although the vast majority of patients I know personally, which is quite a few, is not depressed despite their horrendous myalgic encephalomyelitis symptoms. But that depression is secondary, i.e., it followed the onset of, and was caused by, myalgic encephalomyelitis.

On the other hand, patients who qualify for a primary diagnosis of depression need specific treatments, such as antidepressants and exercise, maybe talk therapy. Those treatments, especially the first two, are very harmful to ME patients. The treatments for ME and depression are polar opposites. Therefore, it is crucial—for both patients with depressions and ME—to distinguish them and not to allow patients with primary depression to be diagnosed with ME, especially when it predates the diagnosis of ME.

For myalgic encephalomyelitis, a disease that, for decades, has been claimed to be “all in patients’ heads” by many ignorant physicians, researchers and the media—even Dr. Ian Lipkin was turned down for an NIH grant recently with the rationale that NIH wasn’t going to spend money on a somatoform disorder—allowing in psychiatric conditions is disastrous.

If the criteria for a physical disease, like myalgic encephalomyelitis, such as the IOM criteria, do not screen out psychiatric conditions, then you basically end up with a diagnosis that is not clean because it invites diagnosing patients who are primarily psychiatrically ill because there are many more patients with primary psychiatric conditions than there are true ME patients. In other words, those criteria will be overly broad and, thus, basically will have defined the disease, in this case, myalgic encephalomyelitis, out of existence.


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Behavioral Health: Undue Influence by NIH on IOM ME/CFS Study

This coming Tuesday is the day of the unveiling of the IOM report on a new clinical case definition and new name for ME/CFS commissioned by HHS for $1 million. Although HHS did everything in their power to lobby for the IOM, the report lacks in credibility in ways too numerous to list here. So, let me focus on one, the strong appearance of undue influence by NIH on the IOM resulting in the inclusion of behavioral-health specialists on the IOM ME/CFS committee.

NIH’s Insistence on Including Behavioral Health

Many of you may remember HHS’s touting of the IOM as an institution that provides objective and independent advice. That does not jibe with the charge by Steven Coughlin, PhD, MPH, adjunct professor of epidemiology at Emory University in Atlanta, and others, that the IOM was influenced in rendering past Gulf War Illness reports by the sponsoring agency, the VA, to include “speakers … to brief the [GWI] IOM committee [presenting] the view that the illness may be psychiatric, although science long ago discredited that position.”

And yet, the exact same thing seems to have happened here with respect to the IOM committee for ME/CFS. NIH demanded that behavioral-health specialists be included as panel members and the IOM obliged without even an iota of resistance. This is how we ended up with two psychologists on the IOM panel, Dr. Cleeland and Dr. Alegria. Of interest is, e.g., that Dr. Alegria has co-authored a paper that classifies CFS as a neurasthenia spectrum disorder.

Hard not to feel like the IOM’s claim of independence is nothing but a PR stunt, huh? It does make sense; after all, the IOM relies heavily on federal-government money for its operations. It’s difficult to imagine any real independence—independence that goes beyond lip service— when a financial dependence exists. No wonder then that there was not a sliver of doubt on the part of NIH that the IOM would “accept” the ME/CFS contract, as NIH-internal correspondence reveals:

I’m sure they want the business.


Speaking of business, the total estimated cost for the meetings—based on the conference approval request by Dr. Lee to Dr. Koh— is $237,533. Since the committee members are not compensated beyond their expenses (included in the cost), does that mean that the IOM’s profit was over $762,000? That’s taxpayer money! Moreover, it looks like HHS budgeted (see approval request) and paid for seven meetings, but only five took place. It would follow that the IOM’s cost was actually lower than estimated and the IOM’s profit even higher. In any event, it would be quite the profit margin, especially when you consider that HHS’s initial total estimate for the ME/CFS “study” was $750,000 and that the IOM Gulf War Illness case-definition report from just last year cost “only” $850,000. Inflation really kills you, doesn’t it?

But anyway, if it’s business, why not get what you really want when you have all the bargaining power. In the case of NIH, that was, among other things, to include the psych lobby. And so they did and here is how.

On August 19, 2013, NIH provided a Statement of Work/Request for Proposal (SOW/RFP) to the IOM, which you can find here. The SOW/RFP contained the following language under “Task Description” with respect to the committee membership:

This Committee shall have expertise in areas necessary to address the topic areas identified below, including expertise in the pathophysiology, spectrum of disease, and clinical care of ME/CFS; neurology; immunology; pain; rheumatology; infectious disease; cardiology; endocrinology; primary care, nursing, and other healthcare fields; health education; and the patient/family perspective.

Note that ME/CFS experts were included. Based on the SOW/RFP, the IOM submitted to the NIH the first version of their Technical Proposal on August 23, 2013. All drafts of that document have been claimed exempt under FOIA, so I do not have a copy of those. On August 30, 2013, NIH sent an email to the IOM in reply with “issues and concerns.” Here is one of the additions NIH requested IOM to make to the proposal:

Prerequisite that committee expertise include ME/CFS and behavioral science

Well, since ME/CFS expertise was most likely already part of the proposal (as the IOM was working off NIH’s SOW/RFP, see above), the only specialty NIH added was behavioral science. Whoever drafted the SOW/RFP, probably somebody in the Office of Women’s Health at HHS (Take a guess!), dropped the ball and didn’t include behavioral-health specialists. Well—sarcasm alert—NIH “fixed” that. Could there still be any doubts about NIH’s agenda when it comes to our disease?

As a result, the IOM complied with NIH’s demands by submitting a revised proposal with the following language that, wouldn’t you know it, includes behavioral health (see NIH email of September 10, 2013):

 The committee will include approximately 15 members with expertise in the following areas: epidemiology; clinical medicine/primary care and other health care fields particularly with expertise in ME/CFS including behavioral health, neurology, rheumatology, immunology, pain, infectious disease, cardiology, endocrinology, and scientists and physicians with experience in developing clinical case definitions.

But that was still not good enough for NIH. The agency wrote to the IOM on September 10, 2013 with the following not too subtle “proposed” change:

The committee will include approximately 15 members with expertise in the following areas: epidemiology; clinical medicine/primary care and other health care fields particularly with expertise in ME/CFS including neurology, rheumatology, immunology, pain, infectious disease, behavioral health, cardiology, endocrinology, and scientists and physicians with experience in developing clinical case definitions.

See what NIH were trying to do here? They were trying to bury “behavioral health” in the middle of the sentence, most likely in hopes that those brain-fogged patients won’t notice. That’s the entirety of this change request with respect to this particular sentence: change the order of specialties to move behavioral health, so it wouldn’t be the first specialty after “ME/CFS including ….” Wouldn’t want to be too obvious, would they?

And voila’, IOM’s final technical proposal of September 12, 2013 linked to here says (under “Work Plan, Expertise”) exactly what NIH “proposed.” It’s a miracle! The IOM apparently operates based on an atypical definition of “independent.”

All About Appearances

Dr. Lee’s conference approval request (under “Location”) makes it very clear that HHS’s only real concern is not for actual independence. Instead it’s all about the appearance of independence.

As an unbiased convener, it is important that these meetings do not appear to be led or influenced by HHS. Holding the meetings in the IOM facilities … will reduce the appearance of bias or influence by HHS….

P2P Release

The release date of the NIH’s P2P report—the result of the research equivalent of the IOM “study”— is top secret (woot, woot), but one would probably not be too far off guessing that it will follow shortly on the heels of the IOM announcement, in a well-orchestrated HHS attempt of a one-two knock-out punch. The duplication of efforts by HHS (IOM) and NIH (P2P) culminating in near-simultaneous publications is just one building block for the HHS absurdity we’ve been witnessing for over 30 years and that is climaxing right now.

Early Release of IOM Report

Another of the many mind-boggling snippets about the IOM report is the fact that it is not due, under the task order, until March 22. In other words, it will be released almost six weeks early. Ask yourself when anything government-related has ever been completed early. The IOM contract itself had no time to spare to fall within 2013 fiscal year; otherwise, HHS would have had to bid farewell to almost one million dollars (something I will address in a future post). HHS’s farcical IOM project has not gone according to plan thanks to enormous opposition by experts, patients and advocates. So, it only makes sense that HHS is pushing out the IOM report as soon as possible in a desperate attempt to put a lid on future opposition.

IOM Studied an Oxymoron

But at the end of the day, nothing should come as a surprise here. The fact that the IOM had no qualms taking on “studying” an oxymoron, i.e., the combination of two not only completely different, but also exclusionary medical entities—ME and CFS—makes it hard for the organization whose reputation has been taking numerous beatings recently to escape obvious questions about its scientific rigor. But I guess those IOM overhead costs have to be paid somehow, so something had to give and in this case, it was independence and science.

Note added 2/9/15, 10:15am PST: I received the documents discussed, and linked to, above as a result of my FOIA lawsuit against HHS and NIH. I am continuing to work my way through them. Meanwhile, get this: HHS and NIH are still not in full compliance with the Judge’s order for document production, more than three months after the full production was due.

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FACA Request: Did HHS Orchestrate CFSAC’s P2P Comments?

Today, I filed a request with Barbara James, DFO of CFSAC, under the Federal Advisory Committee Act (FACA) regarding the January 13, 2015 CFSAC meeting and CFSAC’s P2P comments. My letter, which in addition to requesting immediate access to various documents relating to the meeting and comments, shows that FACA was clearly violated by HHS in connection with the last CFSAC meeting, is reproduced below. My last blog post reproducing correspondence with Ms. James gives context for my request.

The public’s P2P comments were due on January, 16, 2015, three days after the CFSAC meeting. Doesn’t it strike anybody as peculiar that the DFO (and CFSAC) was so confident that the Secretary would sign off on the comments on such short notice? After all, CFSAC recommendations have, for years, largely been ignored by the various Secretaries who either haven’t replied to them at all or taken months or years to do so, typically rejecting them.

HHS has never had ME patients’ best interest at heart and it certainly hasn’t with their recent duplicative IOM and P2P initiatives, which have been cloaked in secrecy; been pushed through with the speed of light; been directly opposite to the October 2012 CFSAC recommendation, the letter of the 50 ME/CFS experts to Secretary Sebelius recommending the adoption of the Canadian Consensus Criteria and the letter of 171 advocates to Secretary Sebelius supporting our experts; been excluding both experts and patients from participation in the IOM and P2P efforts in any meaningful way; been designed as unscientific from the start; been wasting taxpayer money when our disease otherwise hardly receives any and been just absurd. Just as an example, two words: jury model! And yet, the Secretary was expected by the DFO (and the committee) to approve the CFSAC P2P comments on the spot, which is not only unprecedented for this patient population, but must have invoked emergency-type procedures. The fact that HHS is so highly interested in having CFSAC provide official comments to the P2P speaks for itself because HHS has made it very clear throughout the entire P2P process that what’s best for patients is not only at the very bottom of the agency’s list; it didn’t even make the list.

The contrast between usual CFSAC business and the handling of the P2P comments is so stark that it compels the question as to whether CFSAC is merely being used by HHS to legitimize the P2P farce. It is certainly curious that CFSAC’s P2P advice to the Secretary seems to have been heavily influenced—when the committee, by law, is supposed to be independent from the parent agency—by HHS through extensive edits made to the P2P Working Group comments. Talk about circular! Was CFSAC’s advice to HHS’s Secretary basically being orchestrated, in large part, by HHS itself?

Via Email: Barbara.James@hhs.gov

January 17, 2015

Re: Request for Records Relating to January 13, 2015 CFSAC Meeting

Dear Ms. James,

I am a patient advocate for Myalgic Encephalomyelitis. I am writing to request disclosure of documents relating to the January 13, 2015 CFSAC meeting (“Meeting”) pursuant to Section 10(b) of the Federal Advisory Committee Act (“FACA”). This section of FACA provides as follows:

“Subject to section 552 of title 5, United States Code, the records, reports, transcripts, minutes, appendixes, working papers, drafts, studies, agenda, or other documents which were made available to or prepared for or by each advisory committee shall be available for public inspection and copying at a single location in the offices of the advisory committee or the agency to which the advisory committee reports until the advisory committee ceases to exist.” [emphasis added]

I hereby request that all documents falling under Section 10(b) of FACA relating to the Meeting be made available immediately. Without limiting the scope of this request, I particularly request that the proposed comments regarding NIH’s ME/CFS Pathways to Prevention (“P2P”) program prepared by the ad hoc CFSAC P2P Working Group and made available by the Working Group to the entire committee for discussion at the Meeting be provided, along with earlier drafts of the proposed comments by the Working Group, whether or not sent to the entire committee, working papers and revisions of the proposed comments, including, without limitation, those suggested and/or requested in writing or verbally by Ms. James, HHS’s Designated Federal Officer for CFSAC, or other HHS personnel, contractor or representative (collectively, “HHS”), whether or not incorporated into the proposed comments by the CFSAC P2P Working Group provided to the full committee and/or discussed at the Meeting and/or sent to Secretary Burwell (collectively, the “Proposed Comments”). My request includes all emails and other correspondence between and/or among CFSAC members (voting members, ex officio members liaison representatives, and/or P2P Working Group members, collectively, “CFSAC members”)), the DFO or HHS relating to the Proposed Comments and the Meeting. I am also requesting all emails from and to patients, advocates and other stakeholders sent to or by Ms. James, HHS or any CFSAC Member requesting or otherwise regarding the Proposed Comments and/or regarding the Meeting.

Please note that government agencies may not require members of the public or other interested parties to file FOIA requests for non-exempt advisory-committee records. (41 C.F.R. §102-3.170). Although records covered by FOIA exemptions may generally be withheld, please note that, in accordance with the Memorandum for Committee Management Officers from James L. Dean, Director, Committee Management Secretariat, dated March 14, 2000 (“Memorandum”), “FOIA Exemption 5 cannot be used to withhold documents reflecting an advisory committee’s internal deliberations” (see also Preamble to final rule under 41 C.F.R. Parts101-6 and 102-3, Federal Register, Vol. 66, No. 139, p. 37731 (July 19, 2001); opinion of the Office of Legal Counsel, U.S. Department of Justice, 12 Op. O.L.C. 73, April 29, 1988, entitled “Disclosure of Advisory Committee Deliberative Materials.”). [emphasis added] Further, as noted in Food Chemical News v. Department of Health and Human Services, 980 F.2nd 1468 (D.C. Cir. 1992), the Court of Appeals for the D.C. Circuit held that:

“… under section 10(b) of FACA an agency is generally obligated to make available for public inspection and copying all materials that were made available to or prepared for or by an advisory committee. Except with respect to those materials that the agency reasonably claims to be exempt from disclosure pursuant to FOIA, a member of the public need not request disclosure in order for FACA 10(b) materials to be made available. Thus, whenever practicable, all 10(b) materials must be available for public inspection and copying before or on the date of the advisory committee meeting to which they apply.” [emphasis added]

Accordingly, pursuant to the Memorandum, “… agencies may not delay making available non-exempt records to interested parties under FOIA procedures as an administrative convenience, or for other reasons.” The Memorandum further states that “[g]iven the plain and unambiguous language contained in section 10(b) of FACA, coupled with controlling case law and DOJ’s FOIA guidance, [the Director, Committee Management Secretariat is] encouraging each Committee Management Officer (CMO) to assure the maximum timely availability of covered advisory committee records.”

To the best of my knowledge, none of the materials requested above, not even the version of the Proposed Comments discussed at the Meeting, were made available to the public before, or on the date of, the meeting in direct violation of FACA section 10(b) and, to my knowledge, have still not been made available. This calls into question whether the Meeting itself qualified as a public meeting since the public was denied access to the key document and background material considered at the Meeting, preventing the required “meaningful opportunity for the public to fully comprehend the work undertaken by the committee.” (see 41 C.F.R. §102-3.170)

The requested documents, once received, will be published on my blog, “Thoughts about M.E.,” to allow the public a full understanding of the circumstances surrounding the Proposed Comments.

This is my third written request with respect to some of the requested material.

Please respond immediately to advise me as to when you will provide me with access to the requested documents. Otherwise, I will promptly pursue legal avenues to enforce FACA compliance.


Jeannette K. Burmeister

(Attorney at Law)


Memorandum for Committee Management Officers from James L. Dean, Director, Committee Management Secretariat, dated March 14, 2000


Sylvia Burwell, Secretary for Health and Human Services (Sylvia.Burwell@hhs.gov)

William B. Schultz, General Counsel of HHS (William.Schultz@hhs.gov)

Director, Committee Management Secretariat, General Services Administration (cms@gsa.gov)

Olga Nelson, Committee Management Officer, Office of the Assistant Secretary for Health, Department of Health and Human Services (olga.nelson@hhs.gov)

CFSAC Voting Members (via CFSAC mailbox: cfsac@hhs.gov):

Susan Levine, M.D. Chair

Adrian M. Casillas, M.D.

Rebecca Patterson Collier, R.N., CCM

Dane B. Cook, Ph.D.

Lisa W. Corbin, M.D.

Mary Ann Fletcher, Ph.D.

Gary E. Kaplan, D.O.

Alisa E. Koch, M.D.

Jose G. Montoya, M.D.

Faith Newton, Ed.D

Donna M. Pearson

CFSAC Ex Offiicio Members:

Jennifer E. Moore, Ph.D., R.N., AHRQ (jennifer.moore@ahrq.hhs.gov)

Ermias Belay, M.D., CDC (eeb8@cdc.gov)

Elizabeth Unger, M.D., Ph.D., CDC (eunger@cdc.gov)

Alaine Perry, M.P.H., CMS (Alaine.Perry@cms.hhs.gov)

Janet W. Maynard, M.D., FDA (janet.maynard@fda.hhs.gov)

Keith Hull, M.D., Ph.D., FDA (keith.hull@fda.hhs.gov)

Deborah Willis-Fillinger, M.D., HRSA (dwillis-fillinger@hrsa.gov)

Mariela C. Shirley, Ph.D., NIH (Shirleym@od.nih.gov)

Susan E. Maier, Ph.D., NIH (Susan Maier maiers@od.nih.gov)

Cheryl A. Williams, SSA (Cheryl.Williams@ssa.gov)

Amanda Wulf, SSA (Amanda.wulf@ssa.gov)


Susan Levine, M.D.

Charmian Proskauer

Claudia Goodell (to be sent once email address obtained)

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January 2015 CFSAC Comments: More HHS Disregard for the Law?

Yesterday, I sent the following email to Ms. James, DFO of CFSAC:

Dear Ms. James,

I heard that the CFSAC P2P Working Group had prepared a document for official submission regarding P2P to be discussed at the upcoming CFSAC meeting and that this report was heavily edited by HHS before being sent to the full committee. Is that true? If it is, then I believe the public should see both the original Working Group document prior to HHS’s editing and the document that went to the full committee.

I look forward to your reply.


Jeannette Burmeister

Ms. James replied as followed:

The draft comments, which will be finalized during tomorrow’s meeting, will be posted to the CFSAC website after the Secretary has signed off on them.

I answered Ms. James with the following email:

Dear Ms. James,

Thank you for your reply. I am afraid, however, that it was not responsive to my question.

So, let me ask again: Was the document that the CFSAC P2P Working Group had prepared as draft comments to be discussed at the CFSAC meeting and, once finalized, to be submitted as official CFSAC P2P comments edited by HHS before being sent to the entire committee? If so, would you please make both versions of the document available.

CFSAC patient representative, Donna Pearson, sent an email to several patients who had asked similar questions, in which she gave her view of the events surrounding the P2P Working Group document and the edits made to that document by HHS. Therefore, I am also requesting that all emails between the Working Group and HHS staff concerning the Working Group document and the HHS edits thereto be made available, so that the public can fully understand what occurred.

I am looking forward to your responsive reply.


Jeannette Burmeister

Just to clarify, my request includes all emails among the Working Group members on the subject.

The HHS actions regarding potentially heavily editing the Working Group document raise serious concerns with respect to the independence of he committee and the lack of transparency. These and other related actions will be investigated to determine any potential violations of FACA and other federal laws and regulations, including a potential violation of the requirement to make documents to be discussed at the meeting available to the public in advance.

Thank you.

PS: Dr. Susan Levine, Chair of CFSAC, and Donna Pearson, CFSAC’s P2P Working Group Chair, were copied on my correspondence with Ms. James.

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

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

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.”

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):


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

We should have lunch soon.–Paris Watson

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

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

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

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

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

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

We have to involve his staff.

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

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

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

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

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

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

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

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

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

Another telling quote by Maier (page 60):

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

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

More secrecy from Maier here (page 64)

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

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

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

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

That smiley face is from the actual email.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

And now the fun parts.

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

Evidence-based Prevention Science Workshop (EbPSW)

Evidence-based Prevention Research Workshop (EbPRW)

Evidence-based Prevention Assessment Workshop (EbPAW)

Prevention Research Assessment Workshop (PRAW)

Prevention Research Evidence Assessment Workshop (PREAW)

More ideas here (page 1):

Prevention Research (PR) workshops

Prevention Workshops (PW)

Or something “Mind the Gap”-y like

Next Steps in Prevention Research

Advancing Prevention Research (APR)

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

And yet more suggestions (page 11):

Prevention Research Assessment Workshops

Prevention Research Assessment Program

Advancing Prevention Research Workshops Series

Advancing Prevention Research Workshops

Some internal reactions:

moar words (page 3)

Whopper? (page 7)

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

Prevention Research Opportunities Under Development (PROUD)

Prevention Research Opportunities for Development (PROD)

Prevention Research Opportunities Program (PROP)

Gaps in Research Assessing Science Program (GRASP)

Gaps Assessment of Science Program (GASP)

Gaps for Research Opportunities Workshops (GROW)

Gasp indeed! And they were not done yet:

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

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

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

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

Way to get a hold of reality again!

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

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

Hours! Nowhere! Wait! What?

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


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)


9. P2P Timeline (.ppt)

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

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

And Paris Watson in reply (page 4):

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

I think I’ll have some prawns now.


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

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

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

In the Court’s order, the Judge noted:

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

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

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

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

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

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

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

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



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

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

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

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


Nancy Klimas

Leonard Jason

Suzanne Vernon

Robert Miller*

Peter Rowe

Mady Hornig

Carmen Green (chair of the workshop)


Susan Maier

Jody Engel

Deborah Langer

Elizabeth Nelson

Wilma Cross Peterman

Katherine Jung

Janet Maynard

Eun-Chung Park

Leorey Saligan

Mariela Shirley

Paris Watson

Jessica Wu

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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





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.


Jeannette K. Burmeister

Patient, Patient Advocate and Attorney at Law


Dr. Francis Collins, NIH

Dr. Tom Frieden, CDC


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

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