Yesterday, the following notice appeared on the P2P ME/CFS website in a red box:
Important Notice: The ODP recently discovered that one set of public comments was not forwarded to the panel for consideration. Because the ODP is committed to ensuring that all public comments have been considered, we have paused the publication process in order to give the panel time to consider the new information and determine if changes are needed before the release of the final report. Once the panel has been able to deliberate, the publication process will resume, and the ODP will announce a new timeline on our website. (emphasis added)
First, let me acknowledge NIH’s public admission of the gross negligence I pointed out in my FOIA appeal. It is never easy to admit that you messed up. And I appreciate NIH trying to remedy the problem. However, this proposed fix is completely inadequate.
Public comments on the P2P report should be considered equally. They should be compared and contrasted, and given equal weight. By failing – through some kind of monumental mistake – to provide the Panel with ALL of the comments at the same time, the missing comments will automatically be considered differently than the comments sent to the Panel in January.
For example, imagine you are a scientist and you’ve written up a recent set of experiments for publication. You’ve finished the Results and Discussion sections; you’ve completed your figures and tables. Then, at the last minute, someone points out to you that you failed to include a large chunk of data in the paper. Do you look at the missing data to see if it changes your paper at all? Or do you rewrite the paper, with the data now included?
Or, since NIH is so fond of the jury analogy for P2P, imagine this jury trial. The jury has deliberated and is about to come into the courtroom to announce their verdict. The judge stops them and says, “We failed to present testimony from a number of witnesses. We don’t have time to do that the usual way, with cross-examination and so on. So just read their statements and see if it changes your mind.” A mistrial would be declared so fast you would get windburn.
The whole point of public comment is for the Panel to have the benefit of outside views on their draft report. The process is designed to give the Panel time to consider ALL the public comment TOGETHER, before revising their draft report. Instead, NIH is now trying to close the barn door after the horses by asking the Panel to read these comments and see if it changes anything in their report.
Here is what I think NIH should do to remedy the situation:
- Reconvene the Panel in person. Provide them with all the public comment. Provide them with the IOM report. Ask them to review all of that information and revise their report again. That is the only fair way to treat those comments that NIH failed to send the Panel in the first place.
- Undertake an audit of the P2P process and staff. This is a monumental screw up (believe me, I’m using much stronger language in my head). There is absolutely no excuse for “misplacing” half of the public comment submitted on this report. It’s even more outrageous because it appears that the comments from HHS’s own advisory committee were among those misplaced. How is this possible!? In the real world, this is the kind of thing that gets you fired. And it’s only one problem among the many that we have uncovered in the P2P operation. NIH needs to audit the Office of Disease Prevention, and establish who is responsible for this string of bad decisions and poor performance.
Do not make the mistake of thinking all this is a technicality. Failure to provide the Panel with all of the public comment when they revised their report undermines the validity of the report. ODP is obliged to handle the public comment fairly. They failed to do so in the most basic, fundamental way.
CFSAC and Mass CFIDS and Mary Dimmock and all the rest of you who submitted such great comments deserve a full and fair hearing. NIH is still not giving that to you, despite it’s supposed commitment to do so.
{palm to forehead}
they should start all over, it’s as simple as all that
thnx for informing us, Jennie
Jennie, thanks again for finding this stuff. I think they should scrap the whole misbegotten project–it never made any sense at all, and is now bogged down in an admitted mess. I do have a recurring fantasy that some of the honest members of the panel read some comments, realized that they had been bamboozled and rebelled, but I guess that is just that–a fantasy…
Unbelievable! What gross incompetence!! You are right – in the private business world, those responsible would be summarily out the door. OMG! What a mess. Thanks for keeping us informed, Jennie.
Is there anything that we all could do on our end as advocates to help correct this fiasco?
Write to the Office of Disease Prevention!
Jennie, thank you for uncovering and following up with this amazing discovery of negligence to patients. I so appreciate how you explain it as well. The way you use your knowledge and career experience is inspiriational!! thank you so much for what you do,
Anita
Thank you, Jennie. Without your diligent digging, we would never know about outrages like this.
Names of people at the NIH to write to? They should be inundated with complaint emails about this gross negligence demanding (not requesting) that the P2P panel be reinstated to consider all the newly found comments. I know I spent hours going line by line on that report and making comments and to think that mine and so many others, including the very fine analysis by CFSAC, was not seen by the panel is infuriating.
Write to Dr. David Murray, the director of the Office of Disease Prevention. And to Dr. James Anderson, Director of the Office of Program Coordination, Planning and Strategic Initiatives.
Dr. James Anderson’s email address: andersonjm@mail.nih.gov
source: https://dpcpsi.nih.gov/staff
Feeling grateful to you Jennie for having done the necessary work to make and substantiate this breech of process of the P2P, an entity that sits so proudly atop a platform of proper processes, and which are exalted by the NIH. This “incident” is unacceptable, as is their suggested fix. I hope the CFSAC full committee members have read this and will take a stand by contacting the P2P to demand correction as you suggest. Feeling deflated.
Day One of IOM Public Testimony, the announcement was made: “Anyone who would like to comment but did not get the chance, there are computers in the hall for you to submit those comments.” Day Two of IOM Public Testimony a second Announcement was made: “Those of you who submitted your Public Comments yesterday will have to resubmit your comments……they were repeated!” Who made these two acknowledgements? Susan Mier, which only leaves me with an obvious pattern: they really do not want your opinion as Patients, but they will delete, ignore, or disacknowledge that you matter in their IOM and P2P opinions and final determinations! At least they are predictable patterns. All future comments need to be submitted with written acknowledgment that they received you public comments.
Day One of IOM Public Testimony, the announcement was made: “Anyone who would like to comment but did not get the chance, there are computers in the hall for you to submit those comments.” Day Two of IOM Public Testimony a second Announcement was made: “Those of you who submitted your Public Comments yesterday will have to resubmit your comments……they were DELEATED!” Who made these two acknowledgements? Susan Mier, which only leaves me with an obvious pattern: they really do not want your opinion as Patients, but they will delete, ignore, or disacknowledge that you matter in their IOM and P2P opinions and final determinations! At least they are predictable patterns. All future comments need to be submitted with written acknowledgment that they received you public comments.
Two things: First, the IOM public comment process was handled completely differently and separately. I’ve had no problem getting access to the more than 6,500 pages of public comments submitted to IOM.
Regarding comments submitted during the P2P meeting, there were a number of problems as you know. I filed a FOIA request for all of those comments too, but have not received any to date.
I know my comments were deleted at the IOM, if Susan Mier made those acknowledgments. She is the common factor in missing commentaries. I agree that the IOM has shown much more respect, But the fact remains that NIH and The CDC gave these committees what they wanted them to know in an effort to Direct the outcomes.
Diane, I’m confused. The computers for submitting comments were at P2P, not IOM. And Susan Maier had nothing to do with IOM comments. She would never have made a statement about IOM comments because she has nothing to do with those. If you are talking about the meeting you and I attended in December 2014, that was P2P.
Jennie, I apologize for my confusion. Yes. It was the P2P Meetings. So, I still do not understand how the comments made on the computers on that first day were deleted as Susan announced on day two? They had to be sent to someone involved with Communications? If we make comment to CFSAC we already know that the voting members do not get the information in advance of the meetings. I once concluded that the reason so many on the panel had their heads down during the Public Comments was because they were following the speakers presentation by reading along with their previously submitted statements. Why were they not giving the Patient Public Commenter their full and undivided attention if they did not have those required early submission comments in their possession? We later learned that they were not give those Patient Public Comments in their Meeting Packets. How do we trust any of these agencies when patients like you are so earnest in getting their facts right and yet they have more effort in slowing our hope for advancements than getting us the health care we need to live a fair and equal QoL?
Do we know what ‘one set of public comments…’ actually refers to? Could it be one source of comment or multiple sources submitting via one method?
And could this refer to public comment on the draft report text or to public testimony pre-dating release of the draft report?
I am confused with all the various things that have been happening in our world of late.
Thanks!
This definitely refers to comments submitted on the draft P2P report, not before. “One set” is not defined, but I notified the FOIA office that dozens of comments were missing and named three comments by name. Since we all used the same email address to submit comments, it’s hard to imagine how “one set” was misplaced.
Why write to the Office of Disease Prevention if they were the ones responsible for this? Dr. Murray would only be expected to cover up and defend. Names of the heads of the NIH? Have any names for those in the Office of the Director? Thank you.
Is the Office of Program Coordination that you cite within the ODP?
James Anderson is in the Office of the Director, placed above ODP.
here’s his email address andersonjm@mail.nih.gov
source: https://dpcpsi.nih.gov/staff
Well done again, Jennie! Your sleuthing is just extraordinary..
Were the CFSAC comments actually among those not included? That would be incredible if true..
I believe the CFSAC comments were among those not included, but ODP has not stated publicly which ones were in the “one set.”
“In the real world, this is the kind of thing that gets you fired.”
But in the wacky world of government, this kind of screw up gets you a Presidential Medal. Former CIA Director George Tenet comes to mind.
Right from the start I felt that if the report didn’t come to the proper conclusions, it would simply be buried. I must say, this is a rather unique way to dispose of their despised process and report. I expect that pretty soon they will announce (or maybe they won’t bother) that there is no money left to properly finish the report, so it will stay on “indefinite hold”.
And still not a peep from HHS on their “celebrated” IOM report…
This is utterly unconscionable. Just when we thought the P2P report couldn’t get any worse…..
Couldn’t get worse?
The report I saw called for vastly increased research funding, state of art technology brought to bear on ME/CFS, Center’s of Excellence, International networks, an organized effort to produce validated outcome measures, career paths for ME/CFS researchers, ways to bring new researchers into the field early.
These are all things we have been trying to get for years. They would produce huge breakthroughs in this field..
?????
While I do not know what the final P2P report will say, the P2P process has been fraught with mistakes, bunglings and problems.
I agree the process has had problems but in the end what matters is the report and the report was excellent.
Let’s not forget as well that the same group that bungled with the comments also commissioned a report that is telling the NIH to get off their behinds and actually start devoting resources to ME/CFS.
Jennie – you have documented many shortcomings of the P2P process including ODP initially telling us they would not retain submitted comments. Many thanks for doing so.
— Thanks also for:
having the foresight to create the P2P Library so we/you could have a record of submitted comments;
requesting all of the comments including those submitted during the meeting;
comparing those in your library to those you received and noticing(!) that NIH had not given you all of the comments that were submitted.
— I am guessing that the evidence review and P2P meeting cost somewhere around $500,000. Given that last year NIH spent a measly $5,000,000 on “cfs” research, the cost of the evidence review and the P2P meeting look like a huge chunk of money to us.
— It seems to me that NIH ‘s credibility is in question when they repeatedly say that the science on this disease is lacking in rigor yet their own P2P process lack sufficient rigor to keep track of the submitted comments on the draft P2P report.
ditto!!! every word.
I don’t agree that someone should be fired. You may end up firing the same person that was responsible for commissioning this report. Given how good the P2P report is, that would be a tragedy.
This is probably yet another bureaucratic lapse and there have been several. The most important thing, though, is that the report got done. The person who commissioned it surely considered that the Panel would find many gaps in the NIH’s approach to ME/CFS and suggest many changes – which they did.
Whoever was responsible for the commissioning of the IOM and P2P reports did ME/CFS a huge favor.
Let’s not forget that.
>Whoever was responsible for the commissioning of the IOM and P2P reports >did ME/CFS a huge favor.
>
>Let’s not forget that.
Yes, with friends like the NIH and CDC, who needs enemies?
I certainly am not forgetting that they were attempting to orchestrate a pre-determined result, just like Straus and Fukuda were attempting to re-define the illness out of existence.
I remember how they did this as a way to subvert the call for adopting the CCC definition. I remember that they created a phony “jury process” of non-experts to evaluate a complicated illness. I remember the arbitrary “evidence review” that included psychobabble research and excluded most biomedical research.
We need to take a steam hose to NIH, starting with a retirement party for Dr Fauci.
Got it – get rid of or ignore the biggest medical research funder in the world because you’re pissed off at something they did in the past. While you’re at it ignore the two excellent reports the likes of which we’ve been asking for for years, one of which used the heart of the CCC for a new definition…
Sorry, Jim – I think I will decline!
I agree, don’t shoot someone who is actually trying to help. All you will do is ailianate an alie and create yet another bloker. Will any more public comments improve the outcome, I doubt it. Let’s get more research done and find something which will help us get well again or at least improve our health.
Hahaha, when they start helping, I’ll stop shooting!
We know from the Straus letter what the policy was 20 years ago. And it’s the same policy we are suffering under today. In the last 20 years, funding for research has *dropped*, while the overall NIH budget doubled. In the last 20 years, three centers of excellence were established, only to be closed a mere four years later. In the last 20 years, there have been a half-dozen attempts to redefine the illness out of existence, and each attempt added to the muddle.
If NIH wants me to shutup, all they have to do is dump the dangerous CDC “Toolkit”, issue an RFA (money dedicated to research this illness), and “retire” the psych reviewers from the SEP (panel that reviews grant applications).
None of this requires Congressional approval, Presidential executive orders, or more meetings and reports. And none of this is more than what other patients expect, and receive, from NIH.
This just in…CDC Toolkit “Archived” due to IOM Report
http://www.cdc.gov/cfs/toolkit/archived.html
I am sure, by the way, that somebody has egg on their face at the NIH as we speak. Halting the publication of the report with a public acknowledgement that you screwed up is not something that entity wants to ever do. I imagine no one at the NIH is happy about this – least of all the person who failed to process the comments properly. The audit so to speak has already occurred.
I disagree that the whole process should be reconvened or that the response was “completely inadequate”. I would be surprised if the panel would be happy at starting over. I imagine they would think it was unnecessary and it would be a productive session. I think they can look at the comments and decide whether some of the suggestions should be integrated into the final document – and that’s the appropriate step to take at this point.
I have to clarify something. I was not suggesting the P2P process be scrapped and restarted. Nor was I suggesting a workshop do over. I am suggesting that the five Panelists meet face to face (which always produces a better discussion) to discuss ALL of the comments on equal footing PLUS the IOM report which they did not have before. Then take another look at their report amd make changes if necessary.
If the process had not been bungled, they presumably would have discussed all the comments back in January. But they weren’t given all the comments, and some of the comments missing were quite substantial (CFSAC, Mass CFIDS, and other individual advocates).
When NIH opened the draft for public comment, that was a commitment to receive, process and pass those comments on to the panel. Someone screwed that process up, badly. To ensure that all the comments are weighed equally, not treating some of them as an afterthought, I think the panel should meet to discuss them all.
I meant it would “not” be a productive session.
I expected nothing from the P2P from the first moment when we were told so cheerfully that it was the “jury system” (rather than scientific method). I have been in the process of moving across country, so forgive me if I err here.
For me, the most important conclusion in the report was the flat statement that the Oxford definition should be retired. It is a very short step from there to disavowing everything based on the Oxford definition, which would include much of what is on CDC’s website. I’d like to keep that. I think HHS would like to deep-six it. So I DON’T want this committee reconvened.
I think we should ask that a summary of the missing comments be included as an appendix in the report, including whose recommendations went missing and in what way. (As my son used to say when he was small, “it dropped.”). There should also be a link to the comments themselves in their entirety. There might even be a public conference call.
But we also MUST protest the mysteriously meandering comments AS AN ACT OF GOVERNMENT. My own analogy would be a box of ballots that somehow never made it to headquarters to be counted. Jen could not be more correct in the severity of this “mistake.” “Oops” is not enough.
What concerns me is this: at a time when patient-funded research is bearing fruit, we suddenly faced two government-convened committees to change the definition, and in each instance CFSAC was completely disregarded. We must speak up about that. Bad enough that they ignore what CFSAC says, such as the recommendations in 2004 that the U.S. adopt the CCC, and that CFS be placed in the ICDC-9-CM equivalent of G93.3, and the annual request for centers of excellence and funding commensurate to the size of the affected population and severity of the disease.
Even worse, we have the IOM and P2P replacing CFSAC’s call for an open workshop of specialists to revise the CCC to take current research into account, and then adopt it. You do not have to say negative things about either report to protest the blatant opposition by HHS to CFSAC (as well as the letter signed by 50+ specialists).
HHS always says that CFSAC is only an advisory committee. Yes, but an advisory committee created by CONGRESS. In going against the recommendations of Congress’s advisory committee, in abjectly rejecting CFSAC to create their own secret committees, HHS is not just insulting the public constituents of CFSAC (patients, clinicians, researchers), but also directly insulting Congress.
Who has sponsored the bills creating first CFSCC and then CFSAC? Are they still in Congress? Defying CFSAC is defying Congress. That is the direction I would take this.
A panel of experts was called together to revise the definition. It was called the IOM committee,and it contained many ME/CFS experts along with others outside of the field who added their expertise in their respective fields. In the end CFSAC got exactly what they asked for and it was the CFSAC recommendation that prompted the IOM report.
Studies, not consensus, but studies indicated the CCC was not suitable as a definition. The new definition was based on an analysis of the research. Dr. Klimas, Dr. Bateman, Ron Davis, Lily Chu, Dr. Rowe, I think Dr. Lerner and other well-known experts in the field contributed and Dr. Peterson and others reviewed the report.
How much more expertise do you need? Would CFSAC have picked different experts?
Most of the objections to the IOM report faded when it was realized that the panel contained many ME/CFS experts. At that point it was clear that the report was in good hands.
The IOM report has already done a great deal of good. Everyone will have problems with some parts of it but as Dr. Montoya recently said the report provides the opportunity to change the narrative around ME/CFS.
Cort, it seems you aren’t aware there were and there continue to be a number of people who object to the IOM report.
As for how much good an unvalidated set of criteria can do — that remains to be seen.
And we STILL don’t know what, if position HHS will take on the IOM report.
I’ll put myself with Dr. Montoya, Dr. Klimas, Dr. Bateman, Ron Davis, Suzanne Vernon and others who have, despite whatever flaws it was, recognize that it’s a potential game changer that has and is giving us a tremendous opportunity to make a difference.
When CFSAC meets again I imagine they will be very happy at what their recommendation has finally produced.
As to the unvalidated criteria – no one – no specially picked panel experts – could have come up with a validated criteria without a study or studies – and that obviously wasn’t possible for the group to do….
Saying “it turned out all right” is not a valid response to “they flatly disregarded the recommendation.”
And I don’t agree with it.
Taken just as itself, yes, IOM wasn’t bad at all, tho the name is ridiculous.
But THAT DOES NOT MEAN IT WAS THE SAME RESULT WE WOULD HAVE GOTTEN WITH AN OPEN, PROFESSIONAL WORKSHOP.
The process of an open workshop would in and of itself have been educational.
What we have gotten from NIH and CDC is so BAD, that it makes the IOM report look good. Nevertheless, the committees that wrote both Canadian definitions – all professionals – did a better job.
When “ME/CFS (SEID)” researchers are awarded $500 million in a single year, on the basis of these two reports, I will say, Okay.
If it is $100 million the first year (which can’t be next year because they missed the deadline), they get a qualified okay.
When the IOM physician’s report shows up as CDC’s website, okay.
In all those ways, the IOM and P2P had more clout with HHS than an advisory committee.
But if they fail to achieve those two goals, then they were no BETTER than what CFSAC would have done, and their existence was a direct insult to Congress’s appointed committee.
The ends had better be REALLY good before I’ll acquiesce to saying they justify the means.
But compare the impact a CFSAC sponsored committee would have had with the impact that an IOM report has. The IOM has been around for decades. It’s well respected. It’s where medical professionals go to get answers.
An IOM report was guaranteed to make an impact- and it did. Dr. Montoya stated that the fact that it came from the IOM was what was so important because his colleagues at Stanford respect that group.
The NIH was never going to OK a definition change based on a CFSAC recommendation. Most of the people on the panel aren’t doctors. They don’t see patients. What the NIH did was take CFSAC’s recommendation that a group be formed to come up with a new definition and put it in the hands of the group mostly likely to make an impact – the IOM. It ended up being a great move.
Look at all the publicity it’s gotten and since it’s the IOM the NIH practically has to accept the report.
No disease in the world has ever gotten a 500 million dollar increase! (Maybe HIV/AIDS) It would take a national catastrophe to get a $100 million dollar increase. We won’t get that either but I hope we will get a substantial increase and we can build on that.
Maybe this is too “in the beltway,” but Congress specifically authorizes its funding. It absolutely is connected to Congress.
And Cort, let’s just agree to disagree when we see a substantial increase in REAL ME and CFS funding.
And when CDC replaces the junk on its website with the IOM report.
No use rehashing the same disagreement over and over again.
The part of me that is a historian is appalled by the way the government has behaved, even if individuals have not done badly within the framework.
It’s not in the beltway, because the structure of CFSAC is important to understand. HHS provides CFSAC’s operating budget. If you have a document or reference that says otherwise, I would appreciate seeing it. You are absolutely right that if Congress was directly connected to CFSAC, that would be a great target for advocacy. But the CFSAC charter is signed by the Secretary, it specifies the law authorizing the Secretary to create it, and I’m pretty sure I saw something about HHS providing the funding in the advisory committees database. I would be thrilled if Congress was the authority here, so please share any references you have to that effect!
Mary, one correction. CFSAC was not created by Congress. It is a discretionary advisory committee, meaning that it is convened on the Secretary of HHS’s authority. It’s charter is on a two year renewal cycle. HHS has the perogative to accept or reject the committee’s recommendations. Given how often the recommendations are denied, it’s not entirely clear to me why the Secretary keeps reauthorizing it. In any case, Congress has nothing to do with it.
Thank you for this, Jennie. I totally agree that their solution is inadequate.
I agree that all public comments should be considered by the P2P panel. I do not agree that it is in patients’ interest to start over or follow a long process to finalize this report. Patients need much more federal research, and the momentum for a stronger research program at NIH is right now. We need to push Secretary of Health Burwell and NIH Director Collins to commit to an action plan based on the call from both the IOM and P2P panels to conduct a serious scientific research program.
The IOM report, whether you agree with the precise diagnostic criteria or not, got the most validating public attention ME/CFS has gotten in my 20 year experience with this illness. New York Times, Wall Street Journal, Journal of American Medical Association, Annals of Internal Medicine all broadcast the message from the esteemed Institute of Medicine that the disease is serious and needs to be properly treated. It is the kind of independent set of recommendations that moves government. On the heels of its public release, two game-changing scientific studies were published by Drs. Ian Lipkin and Mady Hornig at Columbia University, also covered extensively in public media backed by Dr. Lipkin’s leading reputation in immunology.
The P2P draft recommendations are a blueprint for a strong research program in the scientific and medical communities. Networks of translational research centers, immunological, genetic and neurological studies, more clinical trials, new investigator programs, epidemiological studies, development of diagnostics and prognostics. 90-95% of what is in the P2P report is very good for patients, and needs to be turned into a research action plan at NIH. We need a final report to do that.
I feel urgency about taking advantage of the momentum for a new approach to ME/CFS science as the Secretary of Health considers the IOM report and its recommendations. I believe we need to insist on an NIH research program as an essential ingredient in considering the IOM’s recommendations. The P2P Panel provides the blueprint for a strong federal research program, and Dr. Lipkin’s studies provide the immediate, high quality evidence that investing in ME/CFS science will produce scientific discoveries.
Of course the final P2P Panel needs to review all public comments. I hope they do it expeditiously, without a long process, so that we can use the recommendations of independent scientists to move desperately needed scientific work and funding forward.
My complaint to Dr Anderson:
Dear Dr Anderson,
I am extremely disappointed to hear that, just when the P2P Panel report is about to be published, it transpires that one set of public comments was not forwarded to the panel for consideration. How can this happen?
I am a badly affected sufferer of ME/CFS and put considerable effort and careful thought into my submission, as did many other patients and organisations. It is unthinkable and distressing to realize that our comments may not even have been forwarded to the Panel. How annoyed must the Panel members be!
It shows a high level of incompetence and carelessness on the part of those responsible. The patient group already had many problems with this group and this huge blunder will only add to lack of confidence in your organization. How many extra dollars do such blunders cost the taxpayer?
I hope the problem will be resolved soon with an apology to patient groups. Of course, funds should be expended on useful research instead inquiries and the bungles resulting from their administration.
Sent on 4 April
And here is the prompt and meaningless reply. No apology, of course:
Thank you for contacting me to express your concern about a delay in release of the Pathways to Prevention Workshop (P2P) report on “Advancing the Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome”. This review process is overseen by the Office of Disease Prevention (ODP) within the Division that I direct at the National Institutes of Health (NIH) USA. https://prevention.nih.gov/programs-events/pathways-to-prevention/workshops/me-cfs
I am sorry that you along with millions of others suffer from ME/CFS. NIH is committed to identifying promising areas for research where can we learn about the causes and possible treatments for this disabling condition. One approach used at NIH to identify opportunities for research is through the P2P expert panel review process. In 2104 ODP asked an expert panel to 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.
As you note in your email to me, and ODP reported on their website. “Important Notice: The ODP recently discovered that one set of public comments was not forwarded to the panel for consideration. Because the ODP is committed to ensuring that all public comments have been considered, we have paused the publication process in order to give the panel time to consider the new information and determine if changes are needed before the release of the final report. Once the panel has been able to deliberate, the publication process will resume, and the ODP will announce a new timeline on our website.”
Once the panel has been able to consider these comments they will finalize their report and release it on the ODP website listed above. Checking this website will be the most convenient way for you to learn when the report is released.
Thank you,
James M. Anderson, MD, PhD
NIH Deputy Director
Program Coordination
Planning and Strategic Initiatives
I am in agreement with Cort when he said that no one needs to be fired over this, but I agree with Jennie about gathering the panel to review and consider any important changes that might be suggested by the “missing” comments and the IOM report before final publication of the P2P report. I agree that an in-person meeting would be most fruitful.
Suzanna wrote a great letter, and the reply from Dr. Anderson is a collection of talking points about the NIH, the disease, the report and its process; information we all already know. I hope this an example of pure bureaucratic dodge ball and not a reflection of his lack of knowledge on this topic.
And lastly, John, the point is not whether having the panel read these “missing” comments will change their final report or not; we’ll never know what gravity they would have exerted had they been included with the others, but rather a matter of following protocol for a group that typically exemplifies all that is strict process. Additionally, I would like to hope that in the CFSAC 20+ page comment there is at least some food for thought that may inspire the panel to make some changes and affect the final document in a positive way. Some of those same points were likely mirrored in other “missing” comments, providing the panel with just that small nudge needed for them to see something they hadn’t seen earlier, and those other comments may also contain novel observations not yet regarded by the panel.
After doing a little research, I quickly learned I was wrong ab out CFSAC. It is indeed created by the Dept. of Health and Human Services itself.
Turns out I had remembered the set-up for the CFSCC (the Chronic Fatigue Syndrome Coordinating Committee), which preceded CFSAC – and, for that matter, the CFS-ICC which preceded CFSCC. CFSAC was created when I was in a major relapse off Ampligen and I missed all the details (sometimes I think of my life with this disease that of someone walking down a street where the manhole covers are missing – I’m doing fine, walking around, and then whoosh! down into the manhole.)
CFSCC was created by Congress, overseen by Congress, formally reported to Congress. They gave us at least five minutes for testimony, and there was always a microphone set up in the middle of the aisle so we could ask questions of each government representative (CDC, NIH, etc.) after their reports. (At CFSAC we are silenced and told if we have any comments to put them in the three-minute testimony period at the end …)
I had not realized that the biggest flaw with CFSAC was it was internal to HHS.
Back in 2000-2001, the incoming Bush administration made it clear that they intended to kill the coordinating committees. So our friends (and we do have friends) at NIH tried to preserve the CFS committee by hiding it within the office of women’s health in the Secretary’s office at HHS – which turned out not to be such a good hiding place. It is now created by HHS, not Congress, and no longer answers to Congress.
BUT – remember the CDC scandal?
Congress funds everything that happens in the Executive Branch, and the Executive Branch is answerable to Congress for misspent funds.
So although it’s not a direct route, technically, HHS has to answer to Congress for deceiving constituents. When they told the IOM committee that CFSAC had requested that IOM examine the name and definition (which CFSAC did not do), and then when they “lost” CFSAC’s submitted report to the P2P committee – both of these are infractions that Congress can call them on.
That said, Congress isn’t particularly interested in us or in investigating malfeasance at the moment!
But if anybody has a close relationship with a member of Congress, they should tell them what is going on between HHS and CFSAC. Wouldn’t hurt.
Jennie,
Thank you for discovering the ODP public comment mistake.
Your comments along with several others helped me in thinking about this issue. Your blog serves an important purpose.
The following is my email dated 4-9-2015 to the five members of the P2P Panel and Dr. James Anderson.
Copies were also sent to Secretary Burwell and Dr. Collins. I also attached a copy of the comments that I submitted to the P2P panel on January 14, 2015.
RE: NIH Pathways to Prevention (P2P) ME/CFS Public Comments
Dr. Green; Ms. Cowan; Dr. Elk; Dr. O’Neil; Dr. Rasmussen; and Dr. Anderson:
My interest in the P2P process and the integrity of the final report is based on the fact that my daughter has suffered from ME/CFS since October 31, 2005. I am hopeful that the P2P report along with the Institute of Medicine (IOM) report will focus attention on this disease and significantly increase NIH funding and research to find a cure.
I would like to offer the following comments regarding the Office of Disease Prevention (ODP) statement on April 2, 2015 that “one set of public comments was not forwarded to the panel for consideration.”
1. If the P2P panel met in person to review the public comments in January, 2015, I urge the panel to again meet in person to review and discuss the comments that were not previously considered.
2. Whether or not your panel met in person in January, I suggest the five panelists hold a face to face meeting at this time. I believe a face to face meeting always produces a better discussion.
3. Since the IOM report is now available, I urge the P2P panel to consider the IOM report and, if the panel deems necessary, make appropriate changes in its final report.
4. I believe the final P2P report should clearly explain the fact that the ODP did not initially provide the panel with a complete set of public comments and the manner in which the five panelists decided to correct this mistake. I believe it is essential for the resolution of this mistake to be handled in a manner that is supported by all five panelists, since their names will appear on the report. The resolution of the ODP mistake should be in accordance with the wishes of the P2P Panel and it should not be dictated by NIH.
In the event that you did not receive my comments, attached is a copy of the comments that I submitted to the P2P panel on January 14, 2015.
Thank you for your attention to this email.
Jim Mills