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.