Behind Closed Doors

The following post by Jennie Spotila appeared today on Occupy CFS. It speaks to the secrecy with which the federal government has surrounded all issues pertaining to ME/CFS. 

In this instance, the National Institutes of Health (the agency charged with funding nearly all significant medical research in the country) has convened a workshop - essentially a literature review - to provide the material upon which a definition for the illness will be made.

Significantly, the workshop is not open to the public, nor does it include any ME/CFS experts. There can be only one reason for barring input from the people who know the most about the disease: What they intend to say will not be to our benefit.

Click here to contact the P2P program. Ask who the panelists are, what the results of the workshop will be used for, and if there is to be any public input.

Reprinted with permission.
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By Jennie Spotila

There’s an important meeting happening at NIH today and tomorrow, but you probably know nothing about it. The secrecy of this meeting is intentional, and the implications of decisions made at the meeting are as far-reaching as the Institute of Medicine study. In fact, what I’ve learned about the meeting may strike you as worse than the IOM study process.

Short Version

• The P2P Working Group roster has not been made public.

• The P2P Working Group will finalize the study questions for the evidence review and workshop.

• I can exclusively reveal who was contracted to conduct that evidence review.

• I can exclusively reveal the draft study questions.

• The P2P panel, which will conduct the Workshop and write its report, will be 100% non-ME/CFS experts.

What Meeting Is This?

January 6-7th is the first meeting of the Working Group for the Pathways to Prevention Workshop on ME/CFS. You may be more familiar with the old name for the meeting, the NIH Evidence-based Methodology Workshop. At the May 2013 CFS Advisory Committee meeting, Dr. Susan Maier clarified the purpose of the Workshop “is to identify methodological and scientific weaknesses in a scientific area and move the field forward through the unbiased and evidence-based assessment of a very complex clinical issue.” The Workshop itself will not create a research definition for ME/CFS, but Dr. Nancy Lee said that the output of the workshop could be used to inform such a definition. (CFSAC Minutes, May 23, 2013, pp. 6, 48-49)

The Pathways to Prevention Program (P2P) is operated through NIH’s Office of Disease Prevention. Each workshop process takes about a year from start to finish, and its foundation is a technical brief providing “an objective description of the state of the science, a summary of ongoing research, and information on research needs.” This brief is prepared by one of the Agency for Healthcare Research and Quality’s (AHRQ) Evidence-based Practice Centers (EPC).

At today’s meeting, the Working Group will finalize the study questions that frame the entire workshop process. Obviously, the questions are of critical importance since they form the basis for the evidence review and technical brief, as well as the public workshop itself. But before we get to the questions, don’t you want to know who is on the Working Group?

Who Is On This Working Group?

Guess what? We don’t know. At the May 2013 CFSAC meeting, Dr. Maier reported that 35-40 potential names were forwarded to the Office of Disease Prevention for possible service on the Working Group. She said that the list included ME/CFS experts, advocates and patients, including some CFSAC members. Despite vigorous objections expressed by Dr. Mary Ann Fletcher, Dr. Maier did not share the list, did not allow CFSAC to provide input, nor did she indicate a timeline for the release of that roster. (CFSAC Minutes, May 23, 2013, pp. 8, 49)

Unfortunately, Dr. Maier also did not provide the roster at the December 2013 CFSAC meeting and, to my dismay, no one on CFSAC asked her about it. Dr. Maier has also refused an individual request for the roster prior to the meeting, citing “standard procedure,” and there is no indication whether or when that information will be made public.

Why is this a big deal? Because the Working Group helps shape the entire workshop process. According to the P2P site, “the Working Group is involved from the beginning to the end of the workshop planning process; it finalizes the questions that frame the workshop, nominates panelists and speakers, and selects the date of the workshop.” Interestingly, the Working Group is made up of “content area experts from the federal government, academia, and clinical practice.” Dr. Maier said the nomination list included advocates and patients, but we have no way of knowing if any were actually appointed to the Working Group.

The Study Questions

Dr. Beth Collins Sharp described the evidence review process in detail at the May 2013 CFSAC meeting. One of the AHRQ EPCs is contracted to conduct a comprehensive evidence review based on study questions. Those study questions were drafted by unknown federal employees, and are finalized with the input of the Working Group, the EPC and federal participants. This is happening today and tomorrow.

As Dr. Collins-Sharp said in May, “You can’t get the right answer if you don’t ask the right questions.” (CFSAC Minutes, May 23, 2013, p. 12) However, Drs. Maier and Collins-Sharp have refused an individual request for the study questions being presented to the Working Group today, and have said only that the final questions will be posted by AHRQ and ODP but provided no timeline for this. Incidentally, they have also refused to disclose which EPC was contracted to perform this review.

However, I can answer both those questions today because I obtained a copy of the EPC task order through FOIA. The “Small Systematic Review for Diagnosis and Treatment of Myalgic Encephalophyelitis/Chronic Fatigue Syndrome (ME/CFS)” will be conducted by the Oregon Health & Science University for $358,211. I will discuss this contract in more detail in a future post. For now, I draw your attention to the draft questions as stated in the Task Order, and presumably being presented to the Working Group today:

I. How do ME and CFS differ? Do these illnesses lie along the same continuum of severity or are they entirely separate with common symptoms? What makes them different, what makes them the same? What is lacking in each case definition – do the non-overlapping elements of each case definition identify a subset of illnesses or do they encompass the entirety of the population?

II. What tools and measurements will help define the subsets of individuals in the entire spectrum on ME/CFS? Are some of these tools already available and can they reliably detect a subset of illnesses? Is it possible to identify which subset of individuals is not defined by the current tools and measurements? What is unique about the illness quality in those individuals not captured by the tools available?

III. What are the characteristics of the individuals who respond to specific treatments in terms of the spectrum of the disorder? Why do some individuals not respond? What aspect of the disorder is most relieved by specific treatments? For treatments that have been shown to be effective, what are (is) the underlying mechanism(s) of action of that intervention?

IV. What does clinical research on ME/CFS tell us about clinical diagnosis of ME/CFS? Are there hints in the current literature for a consistent defining characteristic? In the clinical realm, what differentiates borderline “cases” into confirmed versus probable? Do co-morbidities help define subsets of the clinical cases?

V. Have previous research findings shaped current clinical practice or are research and clinical practice completely separate with respect to the illness? How much influence does biomedical research help shape [sic] the future of ME/CFS research?

There are so many issues with this list. For starters:

Asking whether ME and CFS differ is critical (I), but this question fails to ask whether the mixed bag of “CFS” is even a valid clinical entity to begin with. It’s also important to note that the remainder of the questions (II-V) revert to lumping ME and CFS back together as one illness.

Question II asks what tools/measurements can be used to identify subsets along the whole spectrum, i.e. NOT whether such a “subset” actually represents a separate illness. It also asks if there is a subset not defined by current tools and measurements. Huh? How could a subset be identified if there are no tools/measurements to identify them?

Question III, the characteristics of patients who do or do not respond to treatment, rests in part on case definition. Will a systematic review dig into the raw data on studies such as the PACE trial or Ampligen trials to identify characteristics of responders and non-responders? Can applicable case definitions in those study cohorts even be assessed retrospectively (e.g. to examine a Fukuda cohort to see how many met the Canadian criteria)? Will the systematic review treat studies with different case definitions as equivalent (e.g. Oxford studies are as valid and relevant as Fukuda studies)?

Question IV strikes me as the question actually being posed in the IOM study. The IOM will be identifying the evidence for various diagnostic criteria, and then develop evidence-based clinical diagnostic criteria.  Including the same type of question here seems needlessly duplicative. And what if the two evidence reviews come up with different answers?

Finally, I can answer Question V myself: it’s both. There are a number of key clinician-researchers who maintain a clinical ME/CFS practice and conduct research. For those individuals, their research influences their clinical care and vice versa. But for the rest of the world, we know that clinical care is completely divorced from ME/CFS research. Based on the horror stories we hear from patients, based on the dramatic under-diagnosis of the disease and simultaneous use of CFS as a wastebasket diagnosis, I think it is abundantly clear that research and clinical practice is separated by a great wall for most patients.
The Working Group’s planning appears to be closed to the public, and we have no input onto the final questions. We wouldn’t even have this draft list if I had not managed to file a successful FOIA request. The anonymous Working Group will finalize the questions, and these will be posted publicly – although we have no timeline for that.

Non-Experts By Design

Supposedly, the Working Group is made up of ME/CFS experts. That’s the impression Dr. Maier gave at the May 2013 meeting, and by the P2P website. But the P2P Panel is a completely different story.

The P2P Panelists perform several functions: review the evidence report produced by the AHRQ review; attend a pre-Workshop webinar to discuss the evidence report and additional materials; attend the Workshop and ask questions of the presenters; prepare a draft panel report; and review and incorporate public comments to finalize the report.

Panelists can be nominated by members of the Working Group BUT there are significant restrictions on their expertise. Specifically, the panelists:

• May be knowledgeable about the general topic under consideration, but must not have published on or have a publicly-stated opinion on the topic.

• Must not have intellectual conflicts, such as participation in statements by professional societies or participation in advocacy groups on the topic.

• Must not hold financial or career (research) interests in the workshop topic.

Let’s be very clear about what this means. If someone has ever published on or made a public statement about the diagnosis and treatment of ME/CFS, he/she is disqualified. If someone has participated in statements from professional societies or participated in advocacy groups, he/she is disqualified. If someone has a financial or research interest in the diagnosis and treatment of ME/CFS, he/she is disqualified. Furthermore, there is no public comment period on the panel roster like there was for the IOM panel. In fact, it’s not even clear to me how far in advance we will know who has been appointed to the panel.

If the IOM process makes you mad, then this process should make you furious. There will be no ME/CFS experts on the panel that writes the Workshop report identifying methodological and scientific weakness in ME/CFS, suggesting research needs, and providing “an unbiased, evidence-based assessment of a complex public health issue.” The only involvement of experts will be through the Working Group and through the presentations made at the Workshop. I only see one upside to this arrangement: anyone who has been associated with the psychogenic model of ME/CFS will also be excluded.

This process may work very well for the “generally noncontroversial topics” that P2P is designed to address. For example, I can easily imagine the benefit of non-experts examining the state of research for a rare genetic disease. Only one other disease has been examined through P2P: polycystic ovary syndrome. The P2P workshop examined the current diagnostic criteria, causes and risk factors, and prevention and treatment strategies. There were only four panel members: an obstetrician-gynecologist, a cardiologist, the executive director of the American College of Nurse-Midwives, and the Executive Dean for Research at the Mayo Clinic. No patients or advocates spoke at this Workshop. It is not clear to me how well received the panel’s recommendations were in the PCOS patient community.

There are obvious problems with trying to apply this process in ME/CFS. First, there is no single body system to focus upon. While the PCOS Workshop could draw on endocrinologists, gynecologists and women’s health experts, what is the specialty pool for ME/CFS? Second, it is well known, and I believe generally accepted, that doctors and researchers without ME/CFS expertise will still have preconceptions about the disease. We need look no further than FDA for an example. It wasn’t until after the four-hour active listening session in April 2013 that FDA representatives, by their own admission, began to understand the seriousness of the disease, and this was a group of people who were familiar with ME/CFS to some extent. If the P2P panel is comprised of people with little ME/CFS knowledge and possibly negative preconceptions, and the Workshop does not include significant participation from ME/CFS patients and advocates, it seems unlikely that the best results will be achieved. Based on our decades of experience with misinformed scientists, clinicians, and policy makers, it is very hard to trust in such a process.

Bottom Line

Almost the entire process of this Workshop is being conducted behind closed doors. The Working Group roster has not been released. The Working Group meeting is not open to the public. The draft questions were obtained only through a FOIA. There is no information about when the final questions will be posted. We have no idea who will be on the Panel, or even who will make that decision. And the only way ME/CFS experts are likely to participate is through the Working Group (IF there are any on the Working Group) and through presentations at the meeting. The extent to which members of the public will be able to participate is completely unclear.

So if you are worried about the lack of ME/CFS experts on the IOM panel, or if you think that the public will not have a sufficient opportunity to participate in the IOM process, pay attention! The NIH P2P process looks even worse. We cannot lose sight of the forest for the trees, and IOM is not the only moving piece on this chessboard.

What can we do? I believe that advocates must demand more information about the P2P Workshop, and must demand meaningful opportunities to participate. The planning and execution of the Workshop should be transparent if it is to have any legitimacy in the advocacy community. I urge you to participate in both the IOM and P2P processes at every opportunity – ask questions, provide input, and present a united front based on the truths we know about ME/CFS. We cannot wait until the end of the P2P process to make our voices heard, especially since this process will provide input into the IOM study.

Move along, nothing to see here

Jennie Spotila, ME/CFS Advocate, posted this piece on her blog, Occupy CFS, today. (Reprinted with permission) For those who have been wondering whatever happened to the request for an investigation into the intimidation of CFSAC members who sought to represent patient interests, the answer has finally come. And the answer is ... 
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Nothing to See Here

By JennieSpotila, Occupy CFS

After more than four months, Assistant Secretary Dr. Howard Koh has finally responded to our request for an investigation into the allegations that Dr. Nancy Lee attempted to intimidate at least two voting members of the CFS Advisory Committee. His response boils down to something along the lines of, “OK people, move along, nothing to see here.” In fact, his letter is so dismissive of the allegations and so vague on what he’s done about it, that it barely qualifies as a response at all.

Quick Review of The Facts

At the May 2013 CFSAC meeting, Eileen Holderman and Dr. Mary Ann Fletcher said that they had been intimidated by Dr. Nancy Lee and threatened with removal from the Committee for expressing their views. They said a third CFSAC member had also been intimidated.

On June 12, 2013, forty-six organizations and advocates wrote to the General Counsel and requested that he investigate the allegations.

On June 21st, the matter was referred to Assistant Secretary Koh. On August 22nd and September 20th, we wrote to Dr. Koh and requested an update on the investigation. We received no response or acknowledgement of our requests.

A Non-Responsive Response

In an letter to Mary Dimmock dated October 31st (but not received by her until November 7th), Dr. Koh finally responded. You can see the full letter here, but I’ll parse the salient points for you:

"The concerns that have been expressed by the members will be taken into consideration as the Committee moves forward in working to accomplish its mission."

This makes no sense at all. Eileen Holderman and Dr. Fletcher did not express “concerns.” A concern is something along the lines of I’m-concerned-that-we-don’t-get-meeting-materials-in-advance. That’s a concern that can be “taken into consideration.” Holderman and Fletcher made allegations of improper conduct by the Designated Federal Officer of the Committee. That’s more than a concern. But Koh doesn’t even acknowledge the nature of the allegations. Nor does he describe what he did to investigate them.

"However, it is important to understand that the Designated Federal Officer for CFSAC, Dr. Nancy C. Lee, has authority to engage in private conversations with individual members of CFSAC."

I am not aware of anyone disputing that Dr. Lee can talk to individual members of CFSAC. The allegations were not about the propriety of Dr. Lee talking to CFSAC members. The allegations were about what she said.  This is what we asked the General Counsel to investigate: Did Dr. Lee tell one or more members of CFSAC that he or she could be removed from the Committee for expressing a point of view? That is the question that must be answered.

"These discussions may be confidential in nature . . ."

Um, okay. As far as I am aware, CFSAC doesn’t deal in matters of national security. They don’t receive confidential corporate documents the way members of FDA advisory committees do. I have no idea what’s so hush hush about it. But even if I accept the proposition that certain discussions are confidential, I hear something a bit ominous in this comment from Dr. Koh. By telling us that those discussions might be confidential, is he saying that Holderman and Fletcher have done something wrong in making their allegations public? Is he actually claiming that they are not permitted to disclose conversations that, at least in their opinion, represent improper behavior by a federal official? Seriously? Is he suggesting that there will be a backlash against any member who speaks out about that kind of behavior? Really?

". . . and also may involve providing information about the rules and regulations of the Federal Advisory Committee Act as they relate to managing CFSAC and the roles and responsibilities of the Committee members."

Permit me to decode this for you.  What this sentence tells me is that Dr. Koh did look into the allegations, although he is completely silent on who he spoke with or what that involved. The sentence also tells me that his conclusion is that Dr. Lee provided information to Holderman and Fletcher (and perhaps the third member too) about the rules and regulations of FACA as it applies to them, and that is the only thing Dr. Lee did.

This simply does not add up. FACA does not state that advisory committee members can be removed for expressing their points of view.  After all, the advisory committee exists for members to do precisely that. Furthermore, FACA requires that advisory committees have a balance of membership and views, so removing a member for expressing a different point of view would unbalance the committee and potentially violate FACA.

Either Fletcher and Holderman are not telling the truth about what Dr. Lee said to them, or Dr. Lee is not telling the truth about what she said to them, or there has been some kind of epic misunderstanding that Koh has failed to identify. And since Koh’s letter gives us no information about whether an investigation was conducted, who was interviewed, and what the findings were, we have no ability to unravel this mess.

"All engaged in this activity should conduct themselves in a manner that is conducive to respectful and candid discussions."

I think this sentence is code for: one or more people are not conducting themselves appropriately and they should knock it off. Of course, the letter does not specify who needs to knock it off. But read between the lines. He has already said that Lee behaved appropriately. So the only people left to knock it off would be the CFSAC members who complained.

Completely Unacceptable

This non-responsive response is unacceptable for so many reasons, it’s hard to know where to begin. We started with seeking advice from multiple sources, including legal, political and advocacy sources. After consultation with a variety of sources, Mary Dimmock has sent a second letter to the General Counsel of HHS. You can read the full letter here, but these are the main points:

• Dr. Koh failed to adequately investigate and resolve the allegations.
• Dr. Koh’s letter contains no evidence or assurance that these allegations are unfounded.
• The failure to resolve the allegations is not at all conducive to respectful and candid discussions.
• Public trust and confidence in the work of the Committee has been undermined and all but destroyed.
• The public cannot trust that Committee members are free to provide honest advice to the Secretary.

The letter then renews our request, that the General Counsel and not Dr. Koh:

"investigate these allegations immediately, and establish whether any voting member of the CFSAC has been intimidated or threatened for expressing their opinions. At a minimum, your response should detail what steps were taken to investigate, your findings on the facts that support or refute the allegations, and what specific corrective action has been taken."

Will it work? I’m not certain. On the one hand, the General Counsel handed us off to Koh before. On the other, Koh’s response is so vague and the issue of public trust so significant, that the General Counsel certainly should step in and do the right thing. I think it’s vitally important to get matters like this on the public record. We are accumulating more and more evidence of a systematic pattern of ignoring our concerns, downplaying the seriousness of the situation, and flat out subversion of good government practices. There are plenty of other people who are interested in this sort of thing, even if the General Counsel isn’t.

It never ceases to amaze me. Do they think we’re stupid? Do they think that hand waving and “These aren’t the droids you’re looking for” Jedi mind tricks actually work? Or are they counting on the media or Congress or the Office of Inspector General* being completely uninterested in what’s going on? We’ll see.

Note: Remember, there is a difference between the Office of the General Counsel (which “supports the development and implementation of the Department’s programs by providing the highest quality legal services”) and the Office of Inspector General (which is “dedicated to combating fraud, waste and abuse and to improving the efficiency of HHS programs.”)

Source: Jennie Spotila, Occupy CFS, Nov 25, 2013