image credit SnorgTees
The P2P process is winding down, with the final report scheduled to be published on June 16th. The public comment saga has not been resolved, and the truth of what happened is buried in typical bureaucratic responses.
As I have previously documented, the NIH Office of Disease Prevention’s first release of P2P public comments pursuant to a FOIA request was woefully incomplete. When I brought this to NIH’s attention by filing a FOIA appeal, ODP discovered that “one set” of comments had been “misplaced.” ODP corrected the error by providing those comments to the P2P Panel and also giving them time to further revise the report if they wished to do so. However, the second FOIA release was also missing comments, and I continued my appeal. The Office of the Inspector General declined to act on my complaint, and NIH’s Office of Management Assessment has reportedly told ODP that their public comment process complied with NIH policy and federal regulations.
Last week, the FOIA office released another set of documents, consisting entirely of comments and questions submitted by the public during the December 2014 P2P meeting. The release did not include the six missing public comments I had identified, nor any other missing comments. To their credit, the FOIA office provided me with a detailed description of the multiple document searches undertaken by ODP. Those searches have been thorough, but the search results do not line up with the rest of the facts.
The letter identified four comments contained in the P2P Library on this website which ODP has no record of receiving: Friedman, Sean, Green and Edsberg. Dr. Friedman’s comments were sent directly to P2P chairman Dr. Carmen Green, so it follows that ODP would have no record of his comments. Sean’s comments were actually included in the second FOIA release (so I have no idea why ODP would claim they have no record of it). H.I. Green’s comments were sent by regular mail. Given that ODP has no record of receiving it, we have to wonder if other comments were submitted by regular mail and not logged by ODP. There is no explanation for why Edsberg’s comments were not received by ODP since they were emailed to the correct email address: prevention @ mail.nih.gov.
However, there are four additional comments missing from the FOIA releases: Fero, Moore, Patton, and Heppner. NIH did not state there was no record of these comments, but none of these were included in the FOIA releases. I spoke with the NIH FOIA office and brought this to their attention. After further discussion with ODP, they sent me a letter stating “NIH neither confirms nor denies the existence of any responsive records because their identities as commenters are protected from release” pursuant to the privacy exemption under FOIA. That sounds like NIH is saying they received those four comments, but NIH has not included them in any of the FOIA releases.
So here is the contradiction: NIH states the searches have been adequate. NIH identified by name the comments they did not receive (Green and Edsberg). NIH refuses to identify by name four other comments, which implies that NIH received them. But those four comments were not included in the FOIA releases, suggesting that NIH does not have them. Which is it? If the search and FOIA production are complete and accurate, then we have at least six comments that were not sent to the P2P Panel. Either that, or the comments were sent to the Panel, in which case the FOIA production is not accurate. It can’t be both.
Given the imminent release of the Panel’s report, I proposed a solution to Dr. David Murray, Director of ODP. Rather than continue to go around in circles about this, I suggested that a caveat be added to the Panel’s report, both in the Annals of Internal Medicine and the online version. Specifically, I suggested that the caveat state: “Due to administrative error, several public comments were not provided to the panel prior to the finalization of this report.” This would maintain transparency and accountability for the error, but also convey the scale of the error and allow publication to proceed.
Dr. Murray responded: “We are confident that all of the comments that we received from the public, either during the meeting or during the public comment period, were shared with the panel and were considered by the panel in developing their final report. As such, we will go forward as planned with the release and publication of the final report on June 16.”
So we are left with a number of questions: Did ODP receive the four comments missing from the release? Were all the comments sent to the Panel? Are there other comments not submitted to the P2P Library that were lost by ODP? We can’t answer these questions, and NIH’s answers still don’t match up with the documents released.
The final P2P report will be published on June 16th (and there will be a telebriefing that day). How many changes did the Panel make to its draft? Will the report reflect the input of the public comments? And the biggest question of all: what will NIH do in response to these recommendations?
“NIH neither confirms nor denies the existence of any responsive records because their identities as commenters are protected from release pursuant to the privacy exemption under FOIA”
“Are there other comments not submitted to the P2P Library that were lost by ODP? We can’t answer these questions, and NIH’s answers still don’t match up with the documents released.”
Is it possible that the panel received persuasive comments by influential commentors, who the NIH does not want known influenced the committee’s decisions?
thank you Jennie! I just sent a copy of my comments to all the govt officials I have email addresses for.
Have you published the FOIA Request Number on your website someplace? I’m interested in submitting a FOIA Request for the processing notes for your request – there shouldn’t be more than a few million pages….
I’ve already filed for the processing notes, but thanks Jim!
Wikipedia:
In United States law, the term Glomar response (aka Glomarization or Glomar denial[1]) refers to a “neither confirm nor deny” response to a Freedom of Information Act (FOIA) request. There are two types of instances in which a Glomarization has been used. The first is in a national security context, where to deny a request on security grounds would provide information that the documents or programs which the requester is seeking indeed exist. Glomarization is also used in the case of privacy, in which a response as to whether or not a person is or is not mentioned in law enforcement files may have a stigmatizing connotation.
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Hmmm, must be National Insecurity at work here. Wouldn’t want the current Enemy du Jour to know who is criticizing NIH policies…
Seriously, this whole public-commenter-privacy shtick is getting old. For me the key is the word “public”. If a person doesn’t want their public comments made public, wouldn’t they sign it “anonymous”? And what gives them the right to keep my name secret when I have openly submitted it on a public comment? Maybe I want people to know that I am trying to do something to prod NIH into useful action, as trivial and useless as my efforts may be.
How do you know that what they are hiding is criticism of the NIH actions? Could it be that they received input from some gov’t entity that they don’t want to share? Is it possible that the panel received persuasive comments by influential commentors, who the NIH does not want known influenced the committee’s decisions? Did any NGO medical associations or insurers possibly chime in? See your definition of Glomar above. It does possibly explain the evasive explanation coming from the NIH.
Great thoughts, Sharon and Jim.
It is highly possible that NIH is fudging the issue of release of identities to hide these influences.
I’m reading a historically-based spy novel at present and it all fits very well!
Great followups, Jennie. Thanks so much. I can’t imagine anyone trying harder than you have, in order to get things straightened out re the comments fiasco. 🙂
Thank you for doing all the follow-up on their public comments – this is so typical of any government entity. The right hand doesn’t know what the left hand is doing, and always deny that anything is amiss! Jennie, you are awesome for trying to make sense of this, when “they” don’t make any sense at all .
“… I proposed a solution to Dr. David Murray, Director of ODP… that a caveat be added to the Panel’s report, both in the Annals of Internal Medicine and the online version…: ‘Due to administrative error, several public comments were not provided to the panel prior to the finalization of this report.’ This would maintain transparency and accountability for the error, but also convey the scale of the error and allow publication to proceed.” (Thank you, Jennie.)
“Annals of Internal Medicine” could include this caveat themselves, couldn’t they? Or could info about this “administrative error” be published in a Letter to the Editor?
You know, there are various websites where individuals can, for example, rate a professor or doctor or hospital, plus add some commentary about their student-or-patient experience with a particular professional or facility.
If it doesn’t already exist then, we (the public) need a website where individuals can rate gov-healthcare bureaucrats and gov-healthcare departments – and publically document their failures, violations, abuses of power, negligence, etc. What if, in addition to individuals, every patient organization in the country (or abroad) participated? What would the data show?
Dear Jennie,
Pardon me for asking for this large favor but would you please explain to me and perhaps others what the P2P is in general? Somewhere I missed the entire P2P or as likely may have forgotten entirely what this is and who ordered it and what it’s goal is. I may have commented myself if this was requested at some point…. I’m familiar with the fact that DHHS instructed the IOM to do a literature search, define CFS/ME (to whit they renamed it as well) and make recommendations which they did. How will the recent IOM report interface/overlap with whatever the P2P requirements are?
I’ve been advocating for several years now re: the issue of having our medical students educated about CFS/ME/SEID. At least the IOM has given definitive diagnostic criteria and recommended that this education of students and current practitioners be done as soon as possible.
I believe that Dr. Unger is still in charge of developing curriculum for medical students. Do you know if anyone or any division was designated to establish and implement a plan that will serve to educate every current practitioner within the near future?
As a comment, I don’t believe that the IOM made a recommendation as to which medical specialty our diagnosis should umbrella under. Pity as until we have our own “specialist” covering our disease, we will continue to be orphaned and told by physicians that “CFS doesn’t fall under the scope of their practice”, a statement I’ve heard quoted almost verbatim by every specialist I’ve ever sought out at my local teaching hospital/clinics/medical university in Augusta, Georgia.
Thank you for any general info or reference to a past website that can explain why and what about the P2P. What does that even stand for, anyway? Hate to ask to start from the beginning and hope I’m not the only one in need of the basics still or again. marcie myers, medically retired BSN, CFS since 1994, patient advocate always.
I’ve lost count of my posts on P2P! Anonymous linked to all the posts tagged with P2P, and also linked to the NIH page describing what P2P is and what the ME/CFS meeting was about.
P2P was ordered by NIH. It’s goal changed over time from creating a research definition to identifying gaps in ME/CFS research and methodology. There was a systematic evidence review conducted by the Agency for Healthcare Research and Quality. The panel of nonexperts used the evidence review and the presentations at the meeting to draft their recommendations. We’re waiting for the final report to be published on Tuesday.
You asked how the IOM report will overlap with the P2P. There was no overlap during the process because the timelines did not line up. So IOM received no input from P2P and P2P received no input from IOM. It is also completely unclear how either report will be used, separately or together. HHS has said nothing at all about what their plans are. This is especially critical for NIH. They commissioned the P2P report, so one would think they would accept the recommendations to increase research, etc. Whether they do remains to be seen.
What is the purpose of the P2P process? A very good question. I don’t think anyone really knows the answer to that anymore, especially within the NIH. The internal NIH emails that Jennie pried loose show just how confused and befuddled those folks are.
For my money, the P2P is just a giant distraction. Maybe Obama’s message to do something got through. But senior managers like Dr Fauci don’t want anything to happen. What to do. Hmmm.
“If you don’t know what to do, do what you know” must be the NIH mission statement. What is it that bureaucracies know how to do? Emails. Conferences. Meetings. Reports.
And that’s what we got.
On Occupy CFS there are many posts where you can learn about P2P – http://occupyme.net/tag/p2p/
NIH has general info here: https://prevention.nih.gov/programs-events/pathways-to-prevention/workshops/me-cfs
The stated NIH intent for the P2P:
” The 2014 Pathways to Prevention Workshop: Advancing the Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome will seek to clarify:
How the research on ME/CFS using multiple case definitions has contributed to the state of the current scientific literature on diagnosis, pathophysiology, treatment, cure, and prevention of ME/CFS
How the measurement outcomes (tools and measures) currently used by researchers of ME/CFS are able to distinguish among those patients diagnosed with ME/CFS, including the sensitivity of the tools and measures to identify subsets of patients according to duration, severity, nature of the illness, onset characteristics, and other categorizations
How the research on treatments or therapies shown to be effective in addressing symptoms of ME/CFS will lead to an understanding of the underlying pathology associated with ME/CFS
How innovative research approaches have provided an understanding of the pathophysiology of ME/CFS, and how this knowledge can be applied to the development of effective and safe treatments.”
HHS has given no indication of what they will do with the IOM report/criteria etc (accept, accept in part, reject?). Nor have they indicated if/how the criteria will be validated.
As for CDC being in charge of developing medical school curriculum – it seems most unusual that they would be doing so for this disease given that they don’t seem to be in charge of medical school curriculum for any other disease. (Please provide links to better inform me if I am mistaken in any part of CDC having a role in med school
curriculum.)
Dear Anonymous, I spoke by phone to the CFSAC on 5/23/13 regarding the need for medical students to be learning about our disease and that I had yet to find a student that even knew what CFS stood for. Within the next day(s), I received a call from Dr. Friedan stating that Dr. Elizabeth Unger was in charge of development of curriculum but that it had to then be approved by the American Association of Medical Universities. I called Dr. Unger and she confirmed the above while adding the m.e.u.’s were already currently available on the CDC’s website for current practitioners to learn about CFS. To the best of my knowledge, she is still in charge of seeing that the above mission is carried out. And I have no idea who is generally in charge of curriculum development for diseases that had no been taught prior. As we all well know, our/my disease has had to fight its way out of obscurity and disbelief into the light of truth as demonstrated by the IOM report and likely the P2P summary tomorrow. Ours is not the first disease to be diagnosed by ruling out other illnesses, Parkinson’s being another. As research develops more certainty, so too will the diagnostic criteria. MS has been researched to the point that it is broken down by age, years since onset, sex, ethnicity, geographical locations, varying types, and much more. It has its subsets that we are anticipating and medications specific to the different types. I hope that will eventually happen with CFS. Both the IOM and the P2P took note that the research currently being done is lacking in numbers, diversity, control groups, and length of time. It’s true but with more monies and more researchers this will come, I hope. marcie myers.