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.
IOM Meeting: Open? Participate At Your Own Risk
The third IOM meeting of the committee tasked with the development of a new case definition for ME/CFS will be held on May 5th and 6th, 2014.
According to the IOM’s listserv message from yesterday, “[on the afternoon of May 5, the committee will hold an information-gathering session that will be open to the public. Interested individuals will be able to attend the open session in person at the National Academies of Science building or virtually via webcast.” [emphasis added] Written comments may be submitted prior to the meeting. If they are submitted by April 23, 2014, the “will be distributed to the committee before the meeting.”
Before people get too excited about the fact that parts of the meeting are open to the public, let’s be clear that the IOM’s understanding of what constitutes a public meting is peculiar at best. There will be no opportunity for the public to participate in the meeting, other than for a few pre-selected, invited speakers. They can hardly be considered “the public.” The public is only welcome to attend the meeting in person (up to a very limited number of people) and via webcast, but there won’t be an open mic for comments or questions and dissenting opinions by the public will definitely not be allowed.
One has to wonder why the IOM deviated from its January 27, 2014 meeting format. The afternoon session of that meeting was also open to the public. But the big difference there was that 15 uninvited speakers were allowed to make comments of 3 minutes each. Could the IOM really not find 45 minutes in its schedule to allow for true public participation? Or was it so threatened by the fact that most speakers expressed their strong opposition to the “study” and the whole IOM process in January that it had to shut that down this time? Is the oh-so powerful and, as we keep hearing, prestigious IOM really that afraid of hearing what patients have to say? Limiting public input to a select few and relegating everybody else to quiet listeners is just another indicator for the disdain that the process has for patients. The IOM is not even trying to give the appearance that it genuinely cares about patients’ opinions. But, then again, we already knew that. The body language of the panel members at the January meeting spoke volumes.
And the possibility to submit written comments is nothing but a red herring. Written comments can be submitted to the committee at any point in time. They will become part of the public record no matter when submitted. Allegedly, if submitted by the deadline, the committee members will read them before the meeting. That may or may not actually happen. But it doesn’t even matter because the real question is whether those comments will carry any weight; more on that below. Spoiler alert: NOT.
So, creating an “open” comment session is the IOM’s way of merely going through the motions. It’s a big charade. But it sure looks good and it’s clearly a great PR move on the part of the IOM.
The “open” IOM session will address the following questions:
1) In your opinion, what are the most important issues that healthcare providers should be educated about when it comes to diagnosis of ME/CFS?
2) What are your thoughts on the current terminology used to describe this disease: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome? If you could suggest new terminology, what would you suggest and why?
There has been some chatter on the Internet among patients about whether they should indeed submit comments. People have said that they feel like they are between a rock and a hard place. If they submit comments, their participation could be interpreted as cooperation with the IOM despite many, if not most, patients opposing the IOM “study.” At the same time, patients are concerned about missing an opportunity to educate the panel.
As I have said before, this is a very personal decision and, at the end of the day, we all have to live with our choices. Having said that, it is my strong conviction that cooperating with the IOM by providing substantive comments will do nothing but lend legitimacy to a flawed process that has the very real risk and is, in fact, designed by HHS, to harm this patient population greatly. Why else would the committee be stacked with a majority of non-experts? These non-experts have no business defining a disease that they have no prior experience with.
I truly mean no disrespect to these non-expert panel members. I am sure they are all accomplished in their area of expertise. I am not questioning that, but they are not experts in THIS disease. The Gulf War Illness committee members probably had similarly impressive credentials and good intentions, but we’ve seen the disastrous results of their efforts. The foremost experts for this disease have stated that this effort will harm patients. And yet, here these non-experts are, not having treated a single patient with this disease or researched the disease in any meaningful way or in any way at all. This is not a purely intellectual exercise. It has taken the experts decades to accumulate their expertise by treating and researching this disease and the non-experts are not going to become experts capable of producing an accurate definition by reading about this extremely complex and very unique disease for a bit more than a year in their spare time. What they have been asked to do is simply not feasible to do competently no matter how much they might want to believe it is or how good their intentions or credentials are.
But back to the comments. There is a snowball’s chance in hell that patients’ comments will have the slightest impact. First of all, how did that work out for us when some members of our community provided input on the provisional panel members and their potential conflicts of interest? In short, it didn’t.
Potential conflict-of-interest issues of panel members were supposed to be discussed during the first meeting, on January 27, 2014. That sure did not occur during the open afternoon session. Maybe there was a closed morning session that day. We don’t know because of the secrecy surrounding this “study.” And if that vetting indeed took place in the morning of January 27, 2014, did we hear about how the panel overcame the concerns some patients raised about some committee members? No. All that was achieved by raising conflict-of-interest issues with the IOM was that the IOM and HHS now are able to claim that patients had a say in the make-up of the committee when it fact we did not. We were duped, as many patients predicted. Not a single panel member was replaced as a result of patients’ concerns. The facts speak for themselves.
Providing comments now will be as effective, as in not effective at all. It serves no other purpose than to legitimize a grossly flawed process. It will allow HHS to claim that the IOM “study” had patient buy-in although the vast majority of patients continue to oppose this “study.”
You still don’t believe me? Ok, let me try to convince you some more. It is true that the Statement of Work provides for patient input. However, the clear task spelled out in the Statement of Work is an evidence-based review of the literature. By definition, that rules out taking into account anecdotal patient stories or comments. The Statement of Work, in effect, prohibits giving weight to patient input because that would be outside the scope of the evidence-based review. Clever, isn’t it?
Also, are patient comments reflected in the Gulf War Illness IOM reports? Remember, the best predictor for future behavior is past behavior.
Providing written comments or, if invited, giving comments at the meeting will not make a single difference in the outcome of the “study.” All it will accomplish is for HHS to be able to claim that patients were given a voice and were on board with this farce when most patients familiar with the issue are not.
I know it’s unsettling to feel helpless and to have no control. But submitting comments is not the way to gain any control. The only thing we can control is not to legitimize this “study” by refusing to participate and by continuing our protest.
Therefore, I will not send in substantive comments. I will, however, send a note repeating my strong and unconditional opposition to the “study” and the process. I urge others to resist the temptation to cooperate by answering the questions posed by the IOM. If you do send comments expressing your opposition (if you, in fact, do oppose), I caution against falling into the trap of adding on, “Should the worst happen and this study continue, then I would like the committee to consider the following.” That is still participating substantively. Remember that HHS does not have good intentions as evidenced quite obviously in many ways.
CFSAC patient representative, Eileen Holderman, who clearly understands the danger of cooperating with the IOM declined to speak at the May IOM meeting in her message to the IOM: “For numerous reasons stated below, I must decline your speaking invitation. I am part of a vast patient advocacy movement that opposes the HHS/IOM Contract to redefine Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). There are many reasons for my (and other advocates’) opposition …” I encourage everybody to read Ms. Holderman’s entire message to the IOM. It’s powerful and inspirational. It explains the reasons for patients’ and advocates’ opposition to the IOM “study” clearly and convincingly.
Latest GWI Report and New GWI Legislation
Remember that, earlier this month, the IOM was unable to come up with a new case definition for Gulf War Illness: a big $850,000 oops. When it comes to dealing with complex diseases and particularly case definitions, the IOM’s lack of expertise is clearly and painfully exposed. The ME/CFS IOM committee is not more qualified to define our disease than the GWI committee was to define GWI.
Recently, new legislation, the Gulf War Health Research Reform Act of 2014, was introduced. The new legislation proposes “not [to] disseminate or use for research, clinical care, benefits, or any other purpose the results of the report of the Institute of Medicine titled Gulf War and Health Report: Volume 9. Treatment for Chronic Multisymptom Illness.”
All of a sudden the IOM is not that prestigious and respected anymore, is it? I believe that there is a real risk to the reputation of the IOM in the long run if it continues to accept tasks that are clearly outside the scope of its expertise. Although I see the clear dilemma for the IOM here. Most of its work is commissioned by the federal government. The IOM is in a precarious position. If it does not deliver the results ordered by the government, it could lose its biggest source of income.
One can only speculate how the careers of those who serve(d) on IOM panels delivering sub-standard reports will be affected. But I do believe in holding people accountable for their actions, especially when these actions affect hundreds of thousands, if not a million, of sick patients and their families.
Of additional interest is that the Gulf War Health Care Reform Act also requires that any future IOM studies of GWI convene committees consisting of only medical professionals who are experienced in treating GWI patients, an obvious common-sense requirement that is blatantly being cast aside in the case of the ME/CFS IOM “study” as it has been in the GWI IOM “studies.” Should any further GWI studies be contracted for with the Institute of Medicine, the Act would also require (1) obtaining the advice of the Research Advisory Committee on Gulf War Veterans’ Illnesses, a FACA committee, regarding the scope of work and the charge and (2) including not less than three members of the Research Advisory Committee on Gulf War Veterans’ Illnesses.
IACFS/ME Conference in San Francisco
It has been reported that two staff members of the IOM assigned to the IOM study attended last week’s IACFS/ME conference in San Francisco. One would have to assume that the associated expenses were covered under the HHS/IOM contract. It is not immediately apparent why IOM staff members who, as such, are not members of the IOM committee would benefit from learning about the science of ME/CFS. But more importantly, did any of the non-experts on the committee attend the conference? They probably could have learned more about ME/CFS by doing so than by reading the literature of only replicated studies for a few months.
It’s becoming clearer every day that the IOM needs to be reined and that its dangerously absolute, yet unwarranted, power needs to be limited.