P2P Final Chapter

The final P2P ME/CFS documents are coming out today. I am severely crashed from family obligations, so in-depth analysis will take me a little longer than normal. But here are quick descriptions of the various articles to get you started:

Final P2P ReportAs of 8:30 am today, this has not yet been published on the NIH P2P website. As of 9:15 am, the final report is available on the NIH site.

P2P Panel’s article in the Annals of Internal Medicine – This reads very much like the Panel’s draft report, and I won’t be surprised if it matches whatever final version ends up on the NIH site.

Overview by Dr. Anthony Komaroff in Annals – If you can only read one document today, start with this one. Dr. Komaroff gives an excellent overview of the intersection between the IOM and P2P reports. This is important because the Panel does not even mention the IOM report in its Annals article.

ME/CFS Treatment article in Annals – This is a summary version of the treatment section of the AHRQ evidence review (prepared for the P2P Panel and presented in December 2014). If you recall, that evidence review found that CBT and GET were the most effective treatments, and made much of the very poor number and design of trials.

ME/CFS Diagnosis article in Annals – This is the summary version of the diagnosis section of the AHRQ evidence review (prepared for the P2P Panel and presented in December 2014). Two things stand out. First, this version has been updated to include references to the IOM report. The P2P Panel did not bother to do so. Second, Dr. Komaroff’s article, in discussing biological abnormalities, largely references the IOM report. Why? Because the evidence review excluded most of this literature.

A playback of the June 16th telebriefing will be available for four weeks afterwards. Use: 888-640-7743 (U.S. and Canada) | 754-333-7735 (Other International Callers)
Enter replay code 118646, followed by the # sign.

Update June 16, 2015 11:37 am: The one hour telebriefing concluded after 30 minutes. Only one report, Miriam Tucker, asked a question. Deborah Langer of the Office of Disease Prevention repeatedly stated that there were no other question. However, I want to be VERY CLEAR: I identified myself as a writer for Occupy CFS when I joined the call. I made SIX ATTEMPTS to ask a question. My place in the queue was never recognized and I was never given the opportunity to ask a question. If any other members of the media attended the briefing, they did not ask questions. This was an appalling way to end the P2P process.

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Stuck? Four Months of Almost Nothing

In this guest post, Dr. Alan Gurwitt argues that it is time for ME/CFS advocacy to move on and move forward. The post first appeared on the website for the Massachusetts CFIDS/ME & FM Association, and is reprinted here with Alan’s permission.

Turtle-Stuck

image credit: The Poised Life

Four months have passed since the release of the report from the Institute of Medicine on February 10th. In spite of much thoughtful review and debate on the part of patient advocates to attempt to arrive at some consensus about an appropriate name and diagnostic criteria for this terrible disease, so far these efforts have changed nothing, nor will they make a difference without major changes in our tactics and attitudes.

The federal DFO’s (designated federal officers) come and go. The Chronic Fatigue Syndrome Advisory Committee (CFSAC) keeps making reasonable recommendations but is often ignored. There is not a peep from HHS and NIH. Indeed, except for some promising responses from the CDC, there is silence. Dr. Francis Collins, the director of NIH, says he is aware of the requests for greater NIH involvement but continues to do nothing. Dr. Anthony Fauci, in office since 1984 as head of the National Institute of Allergy and Infectious Diseases (NIAID), continues to make it clear he wants nothing to do with ME/CFS. While many agree that the work on ME/CFS belongs in one of NIH’s institutes with research funding, not in an unfunded Office of Women’s Health, there is no person or group at NIH and HHS who is leading the charge and no indication so far that the leaders of these huge “health” agencies have paid attention to the findings of the IOM report and the preliminary P2P report and plan to respond promptly and significantly. Some individual lower-level personnel have gotten the message and have done what they can, but overriding indifference has prevailed for thirty years and there are no signs of motivation to change. I believe only strong outside forces will cause HHS and NIH to change.

Under present circumstances, it does us no good to sit and wait another four months for the government’s response. Whether or not HHS and NIH respond we patients, advocates, researchers and allies in the medical professions must review and change our tactics and directions, otherwise we will remain stuck in nowheresville. We have tried for years, with some success to make our illness and cause known but our struggle too often is ignored or seen as unwelcome. At times it seems like war for recognition and survival.

Alone, we are weak, vulnerable, and ineffective. We must supplement and organize our forces and improve our strategies going forward.

So, where should we go from here? I believe that there needs to be a series of coordinated steps to build an effective and constructive force. As I see it, the possible steps are the following:

  • We have been told for years that the federal health agencies will only shift course when Congress demands it. We should establish a group to research and plan how to best educate and recruit Congress people from as many states as possible to act together in Congress. ME/CFS is a bipartisan cause and a very serious national problem. Coordination will be absolutely key.
  • Recruit a coalition of medical professionals, both researchers and clinicians, and institutions outside of the government to map out what are the key areas of needed research, both basic and clinical. This may not be hard to do as there is already much cooperation thanks to the IACFS/ME.
  • Form a planning group to think through the goals of a long overdue national ME/CFS organization, its possible structure, and means of creating and coordinating the above steps. After doing so (six months to no more than a year), implement.
  • Create a group to collaborate with patient groups and clinicians in other countries. ME/CFS doesn’t recognize boundaries. There is much to learn from one another. Australia and New Zealand have succeeded in educating a higher percentage of physicians. Norway is doing key research on whether ME/CFS is an autoimmune illness. In all these cases patient organizations have played a key part.
  • We must stop the pattern of fighting and undercutting among ourselves. Such has been an important reason for limited participation and contributed to our fragmentation. If we don’t all work together in a respectful manner to achieve common goals we defeat ourselves. We have large challenges to overcome but at times we have been our own worst enemies.
  • Time is of the essence otherwise positive components of the IOM report might die. Let us not miss the opportunities opened up by the IOM report and important new research.

I believe the IOM and P2P reports are game changers if we utilize the achievable big findings and recommendations. Of course name and diagnostic criteria are important but it is only with further research that both will become clear. The other big findings which we can propel our work now are:

  1. ME/CFS is a biological, not psychological, disease.
  2. For many years patients with ME/CFS have been undiagnosed, misdiagnosed, mistreated and harmed by uninformed healthcare professionals and shamefully negligent medical educators and medical organizations. We must figure out what are the blocks to learning and how to overcome them, otherwise ignorance will continue.
  3. Children and adolescents present somewhat differently but have a better prognosis IF diagnosed early and well managed. Useful pediatric ME/CFS research is even sparser than for adults. That must change.
  4. There are huge gaps in our scientific understanding of ME/CFS in both children and adults as a result of a biased and indifferent federal government which has almost totally failed for decades to provide the necessary research funds and leadership. In response to the initiatives on the part of HHS and NIH to bring about the P2P and IOM reports, the reports seem DOA (dead on arrival) and the leaders AWOL (absent without leave).

In summary, nothing will change until we change. We must not keep waiting for the federal health agencies nor should we go it alone. We must take a series of steps. One step is to create a multi-pronged coordinated and comprehensive effort to recruit congressional support. We must also build a strong national coalition of patients, advocates, and professionals. We have many wonderfully informed, thoughtful, and active patient advocates among us but our failure to coalesce has created a major obstacle. The challenges are great so our efforts must be greatly smarter, focused, and more effective.

Failure to change our efforts and directions will doom us to remaining stuck. We should utilize our own capacities and wait no more.

Dr. Alan Gurwitt’s opinions here are his own and do not represent the Mass. ME/CFS and FM Association and its Board.

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Contradictions And Unanswered Questions

freecontradictionsroyal_fullpic

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?

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Running in the Background

beachballSometimes, there’s no real news to report because things are running in the background. If you are a Mac user, then you are probably familiar with the beach ball of death. It just spins and spins while you wait for your Mac to catch up and be functional again. That’s where we are advocacy-wise right now. I’ve got news but not news, if you know what I mean.

Don’t Worry, It’s Fine

There was a flurry of emails from NIH’s Office of Disease Prevention to myself and other advocates this week. Essentially, these emails boil down to: We gave all the comments to the Panel. They had all the time they wanted to revise the P2P report. The report will be published on June 16th.

But what about the fact that the documents released in response to FOIA requests do not contain all the comments? Rumor has it that there will be another FOIA release soon. It remains to be seen if that release will finally include all of the missing comments. We also don’t know if that release will go out before the June 16th deadline.

In other words, NIH is telling us that they fixed the problem and we shouldn’t worry about it. Personally, I think we need a little more than that. I would like to hear the Panel explain how they handled this public comment fiasco. And of course, we have to see what is in the FOIA release.

There will be a press telebriefing at 11am Eastern on June 16th. The Panel will discuss their findings and take questions from the media. Anyone can listen in on the briefing, and it will be available for playback shortly thereafter. More information on how to join that call can be found here.

Wherefore Art Thou, CFSAC?

This is a time of transition for the CFS Advisory Committee. A new Designated Federal Officer has been appointed to replace Barbara James. Dr. Ledia Martinez has a background in HIV/AIDS issues, and coordinating programs at the Office of Women’s Health.

Some of the other needed replacements have been made. Dr. Jeffrey Kelman replaces Alaine Perry as ex officio from the Center for Medicare and Medicaid Services. Dr. Suchitra Iyer is the new ex officio from the Agency for Healthcare Research and Quality. This is interesting because Dr. Iyer was the contract officer on AHRQ’s systematic evidence review produced for the P2P meeting.

No replacement for Dr. Mariela Shirley from NIH has been announced, so Dr. Susan Maier will serve in that capacity. No word on the new non-voting liaison members of the Committee. And Dr. Gary Kaplan is still listed on the roster, although his term expired on May 15th. No word on whether he will be extended or replaced, but the lack of a solicitation for nominations probably suggests which way that is going.

And the spring meeting that was rumored to be happening in June? Probably not happening in June.

Oh, And By The Way

There was no announcement or fanfare, but AHRQ has published the disposition of public comments on the systematic evidence review. This is a required step in AHRQ’s process. They have to publish how they responded to the public comments on the draft evidence review. They received a lot of comments, and the response document is 274 pages long. I haven’t had a chance to read it yet, but I don’t think much of our collective response document made it in there. Thanks to Maureen for finding the disposition document!

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Incompetence is Not Criminal

There is no disputing the fact that the Office of Disease Prevention botched the public comment process on the P2P report. But according to the Office of the Inspector General, it’s not worth their attention.

In April, I asked the OIG to investigate and take steps to remedy the mismanagement of the public comment process by ODP. There is significant evidence to suggest that the P2P Panel has still not seen all the public comments, and they are due to issue their final report on June 16th.

On May 12th (oh! the irony!), I received an email from OIG stating in part: “no action will be taken in this matter, as the issues outlined constitute management issues that do not warrant investigation for potential violation of criminal statutes within OIG’s jurisdiction.”

This is disingenuous, at best. The OIG does not just conduct criminal investigations, it is “dedicated to combating fraud, waste and abuse and to improving the efficiency of HHS programs.” The OIG is also responsible “for promoting effective management and quality of the agency’s processes and products.” This is not my first rodeo, folks. I would never have bothered with the OIG if their mission was exclusively limited to criminal investigations.

While OIG refused to take any action in this matter, they did suggest I contact NIH’s Office of Management Assessment. The OMA “provides NIH-wide management, oversight and advice to safeguard agency assets, preserve public trust, and provide administrative infrastructure for NIH Institutes and Centers.”

On May 13th, I wrote to the Director of OMA requesting her immediate assistance to investigate and intervene to remedy the public comment violations. I emphasized that time is of the essence, as the P2P report is due to be published in one month. Given the current facts of the situation, this report will be tainted by the compromised public comment process. As a person who will be directly affected by the report and any subsequent action by NIH, I asked that OMA investigate and intervene to ensure that the report is not published until the panel has received and given due consideration to every single comment submitted by the public.

Meanwhile, my FOIA appeal is still pending and no one at NIH (including ODP) has contacted me regarding this mess. And the clock is ticking, friends. The P2P report will be published in one month and I see little reason to trust that the Panel has seen and given equal consideration to all of our comments.

The clock is ticking.

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Very Very Aware

me_and_cfs_ribbon_largeMay 12th is International ME/CFS Awareness Day, selected because it is Florence Nightingale’s birthday. If you look around blogs and social media today, you’ll probably see a lot of blue ribbons and statements from patients. There’s the May 12th Blog Bomb. Niagara Falls and other public places will light up the night. I expect we’ll see an increase in media coverage and personal testimony, like this fabulous piece by Catherine Hale. And many advocates will reach out to politicians to ask for increased research funding and better services.

But here’s the thing: we are just preaching to the choir.

If you read my blog, you are already aware of ME/CFS. If you tune in to any of the awareness activities with more than cursory, passing attention, chances are you are already aware of ME/CFS. Does lighting up Niagara Falls actually spur people who know nothing about the disease to look it up and learn something? Do we even know what the tipping point would be – how much awareness activity saturation you need in order to get strangers to pay attention? I’m not saying these activities are pointless, but we should be very cognizant of the fact that the likely impact is small.

But the politicians and policy makers, you say. What about increasing their awareness? Yes, that is important, and I know that my own Congressmen have a limited level of awareness and concern. Finding ways to increase that could be helpful – if we ever have the resources to launch a legislative campaign.

The people who really need to be aware are the decision makers at CDC, NIH, and HHS. And I am telling you that they are already aware. These agency personnel recognize ME/CFS is a serious disease and an unmet need. They know this. Dr. Francis Collins (Director, NIH) is aware of ME/CFS. CDC is aware. FDA is aware. HHS Secretary Burwell is very aware. These people know about ME/CFS.

The problem is not awareness. The problem is that they are aware, and yet they do not respond with the urgency and commitment required. They are aware, and yet they will not commit more resources to address the science gap. They are aware, and yet we still hear the same excuses that there is no money, the science is hard, we don’t know what we’re studying, ad infinitum, ad nauseam.

Do you want to talk about awareness? I am very aware that my mother spent the last twenty years of her too-short life watching me struggle with this disease. I am very aware that my mother actually feared I had AIDS at one point because I was so sick, so suddenly. I am very aware that I will never run or dance with my niece, and I will never hike with my husband. I am very aware that this illness stole my choice to have children and the career I worked my ass off to build.

Wearing a blue ribbon? Lighting up a building? Writing this blog post? This changes nothing. Even an incremental uptick in awareness is a microscopic drop in the bucket towards building a critical mass of public pressure.

Awareness Day? Great. You are already aware. Our policymakers are already aware. And I am very very very aware that this changes nothing, accomplishes nothing. Because if awareness was enough, we would already have made progress.

We will not see the change that we need and the resource investment that we need until we find a way to leverage the awareness into action. The policy makers will not change their actions and decisions until we force them to. And we will be better served if every single advocate and organization becomes aware of that.

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The Burial of ME

Mary Dimmock has published an extraordinary review of the last thirty years of ME history. With her permission, I’ve reported her announcement with the link to the full document below. I highly recommend reading as much of this document as you can, and saving it for future reference.

Five years ago, I was working in the pharmaceutical industry when my son fell victim to myalgic encephalomyelitis (ME). Overnight, everything I understood about medical care and about how diseases are researched and treatments developed was suddenly turned on its head. This wasn’t medicine or science as I knew them but rather medical disbelief and disdain and a quagmire of conflicting and irreconcilable disease labels, definitions, theories and research findings. My son’s life and his entire future was and is being held hostage by a parade of biases, disinterest, personal agendas, politics and sloppy science that had been going on since before he was even born.

The bald fact is that in the last thirty years, HHS has not only failed to produce a single meaningful outcome for patients but has turned ME into a pariah. We need a sweeping reboot of every single facet of HHS’s public policy toward this disease.  But HHS has been unwilling to make any meaningful changes, let alone the magnitude of changes needed in the timescale needed to address the damage that has been done.

To change the future of ME patients, we have to change the politics and the public perception of this disease. We need to break down the walls of confusion and misinformation that have buried ME. We need to find new ways to tell the shameful story of what has been done to ME patients.

With the intent of providing a tool to help with such efforts, my son and I compiled a detailed, referenced document titled Thirty Years of Disdain: How HHS Buried ME. This document is intended to bring together in one place key events in the story of HHS’s failed public policy toward this disease.

The resulting document is long, making it more suitable as a deep background reference. We are creating shorter, targeted pieces to focus on congressional leaders and the media. The community is welcome to use it if it’s of benefit in their advocacy efforts. http://bit.ly/The_Burial_of_ME

Comments are welcome and can be sent to medimmock@gmail.com. I will do my best to respond.

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Awareness Reboot

Today’s post comes from Denise Lopez-Majano. She makes a powerful argument for the kind of awareness campaign we need.

rebootThe release of the Institute of Medicine report resulted in an unprecedented amount of media coverage and public discussion. As has long been the case, not all comments and discussion have been constructive. In fact, the nastiness of many attitudes held by the public and healthcare providers makes the case for a large-scale awareness campaign to correct misinformed views about patients and this disease.

In his post Alone in the Woods, Joe Landson aptly points out that we all have at least one “dear” friend who knows all about the simple way to overcome our disabilities. These people bubble over with bad advice. But in the 10 weeks since the release of the IOM report, I have seen scores of disparaging and demeaning comments, so many that it was quite difficult to cull just a few.

For example, there are published comments such as this, on an article in The New York Times:

me not frugal
California 25 February 2015

Those claiming to be suffering from CFS are often their own worst enemies. Even the writer uses the loaded word “ignorant” in reference to physicians who did not agree with her self-diagnosis. In my many years of dealing with chronic migraine and nerve pain issues — researching treatments, reading blogs, visiting the neurologist and other caregivers — I have come across innumerable self-diagnosed CFS martyrs, both in person and online. They tend to be people who rant, accuse, judge, whine, compete for who hurts the most, and hold on for dear life to that one thing that makes them feel special and deserving of sympathy. Chronic Fatigue Syndrome. The bald-faced truth is that CFS, whether it is a real medical condition or a compilation of malaise and unhappiness, is the life ring of attention seekers.

And these comments on a Medscape article:

Dr. Wallace Schwam Feb 10, 2015
Absent hard biological evidence, Chronic Fatigue Syndrome might [sic] lots of people as “Sick” who are in monotonous jobs, bad marriages, or plain bored with life.

Dr. James Weber Feb 10, 2015
A new name —–now “BIG PHARM” will come out with a new drug for it !! Oh…… I can see the profits rising !!!!! Nebulous disease, nebulous exam and no definitive test, prospective patients for life !!!! Whatever happened to SSRI’s ?

Views like those of Dr. Forbes, posted on an AAFP article about the IOM report, show up far too often:

Dr. Robert Forbes
3/5/2015 4:27 AM

I have been a family physician for 43 years.

Have practiced in rural Nova Scotia, the Canadian Arctic and Mississippi.

I am sorry but I don’t buy any of this!

I have had patients with chronic fatigue, fibromyalgia (which I call fibro- my life sucks!), attention deficit disorder, autism, chronic yeast infection, premenstrual dysphoric disorder, and now, systemic exertion intolerance disease. Try lazy!

All of them seem to want disability, disabled parking stickers, amphetamines, narcotics or Xanax. And they usually get them only to add to their problems.

I fear we contribute to this in a big way by legitimizing their complaint.

We have become a very dependent society, and I am ashamed and concerned.

Fortunately I am semi-retired and fear no retribution for my free speech.

I did try to be respectful.

Thanks for the opportunity.

Just saying…

RF

Dr. Forbes apologized in a second comment claiming he felt like venting to colleagues–but he vented in a public forum. The truth is that wherever he was venting, his comments are demeaning and derogatory.

It is completely inappropriate for healthcare professionals to speak publicly and disparagingly about patients. People must stop blaming patients for what they (HCPs and others) don’t yet understand. Indeed, the IOM report called out problems with views held by healthcare providers:

…a 2011 study found that 85 percent of health care providers still believed the illness was wholly or partially a psychiatric rather than medical one (Unger, 2011). Numerous studies also have documented skepticism among clinicians about ME/CFS being a distinct clinical entity (Bayliss et al., 2014). (p.257)

A third type of misinformation that must be addressed involves things like this tweet from 26 February 2015 by the Office of Women’s Health (OWH), which conflated chronic fatigue and ME/CFS:

@womenshealth

#Chronicfatigue is real, and women are 2–4x more likely than men to be diagnosed with it. http://go.usa.gov/zA4j  #MECFS

It took the efforts of several advocates to get OWH to delete one erroneous tweet sent on behalf of the office that houses the CFS Advisory Committee (CFSAC). One would think that of all places within the Department of Health and Human Services (HHS), OWH as home to the CFSAC would disseminate accurate information. If OWH spreads incorrect information, there is obviously much to be done to ensure that all of HHS and its agencies understand this disease.

As a community, we don’t have the wherewithal to address each comment, or to educate each healthcare professional. The problem is far too widespread for our scant resources. And if we don’t have the capacity to educate healthcare professionals, it follows that we don’t have the capacity to educate the general public.

We must stop playing “whack-a-mole”.

The changes needed are far more extensive than simply a revised CDC Toolkit.

Mary Dimmock believes a policy reboot is necessary. I agree.

I believe that one component of the policy reboot must be a national awareness campaign. It must be a top-down, comprehensive, authoritative, fully-funded education campaign, one that is emphatically endorsed by HHS and that is clear about the disease under discussion.

A wide array of stakeholders (including patients, advocates, clinicians, and researchers) must be equal partners, in full and open collaboration with HHS in the development, implementation, monitoring, updating, etc. of the entire campaign.

The campaign must point only to validated criteria/material, and must be unequivocal that this is a physiological illness that causes severe disability and a heavy economic impact.

The campaign must include a timeline with clear objectives and goals, as well as provisions for accountability and consequences. It must incorporate an effective means of assessing the campaign’s progress and effectiveness.

In order for this campaign to be successful there must be several areas of focus:

  • It must penetrate throughout HHS and each of its agencies.
  • It must educate healthcare professionals in all specialties, professional organizations, professional/scientific journals, continuing medical education, medical schools, insurance providers, and licensing/accreditation bodies for healthcare professionals, as well as school nurses, pharmacists, home health professionals, and so forth, and must improve public and institutional policies.
  • The campaign must have a public education component.

Each component must address stigma, bias, and misconceptions as well as emphasize assessment and knowledge of this disease, and the need for appropriate diagnosis and care. This campaign must nurture a culture of responsiveness and understanding.

The IOM report suggested the:

Designation of an HHS Point Person

HHS should consider appointing an individual to oversee the dissemination of the new diagnostic criteria nationwide to health care professionals (i.e., a “SEID” czar, within the department). This person should have access to the necessary resources and the authority to implement the dissemination plans for the new criteria and address any questions or concerns that arise. Having such an individual in place will also help demonstrate HHS’s responsiveness to this issue. (p.268)

To be truly effective, I think the campaign must be broader than what is suggested in the IOM report. HHS must partner with stakeholders to develop, implement, and aggressively disseminate a comprehensive education campaign designed to eradicate stigma and bias associated with ME/CFS. It must be absolutely clear about the disease and have the wholehearted endorsement of HHS. It must be fully funded, fully staffed, and take the time required to achieve the necessary changes in negative attitudes among healthcare professionals and the public.

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CFSAC Goings and Comings

There are a number of CFS Advisory Committee tidbits to share, with more goings than comings.

Barbara James, the CFSAC Designated Federal Officer, is retiring from HHS at the end of April. No word on who will replace her. It’s possible that Dr. Nancy Lee will return, at least temporarily, while a new DFO is trained.

Alaine Perry, ex officio from the Center for Medicare and Medicaid Services, has resigned from that position on CFSAC. No word on who will replace her. This is a real loss to CFSAC, as Perry has brought her own experience as an ME/CFS patient to her role on the committee.

Dr. Mariela Shirley, ex officio from NIH, is leaving the Office of Research on Women’s Health and returning to the National Institute on Drug Abuse. This likely means her departure as ex officio, and as chair of the Trans-NIH ME/CFS Working Group. Dr. Susan Maier may return to the role or a new person may be appointed. This is not great timing for turnover given the imminent publication of the P2P report, and what will hopefully be new engagement by NIH in increasing ME/CFS research.

Dr. Gary Kaplan‘s term on CFSAC expires on May 15th. There has been no request for nominations, and given the turnover in the DFO such a request seems unlikely. This is speculation, but it’s likely that his term will be extended or renewed.

Finally, the deadline for nominations for the non-voting liaison positions has passed. The current appointments expire soon, and there is no word on the timeline for new appointments or extension of the current terms.

This is a lot of upheaval under any circumstances. However, the committee will likely meet in June, and a CFSAC Working Group has been considering the implications of the IOM report. CDC is revising its Toolkit, and we are still waiting for an official response from HHS to the IOM recommendations. The impact of CFSAC turnover during this critical time is hard to predict.

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P2P Missteps Continue

There are new developments in the continuing saga that is the NIH’s Office of Disease Prevention’s mismanagement of public comment on the P2P report. When I last wrote about this on April 3rd, ODP had acknowledged that yes indeed, they had failed to send an unspecified number of comments to the Panel. In an attempt to reassure us, ODP said that publication of the report would be delayed so the Panel could review the missing comments and decide if they should change anything in the report.

On April 7th, I received a second release of documents under my FOIA request, described as consisting of all the remaining comments. But that was not true. I carefully reviewed the documents and compared them with what was submitted to me for the P2P Library. I asked another advocate to double check my work. There are still comments missing – I can document at least six. I filed a second appeal on April 13th, but then on April 16th, ODP announced that the final report would be published on June 16, 2015.

There are several possibilities:

  1. Maybe those six comments were not received by NIH. But I was copied on the actual emails to NIH in several cases, so that is not likely to be the case.
  2. Maybe those six comments were sent to the Panel, but not sent to the FOIA office for release to me. This would represent a continuing and disturbingly lax approach to document management.
  3. Maybe those comments were not sent to the Panel when the rest of the missing “set” was sent to them after I uncovered the problem.  This is the worst possibility of all.

We are left with difficult questions about the integrity and validity of the process:

  1. Has the Panel received all the comments, or are there still some missing?
  2. How much time was the Panel given to consider the set of comments sent to them a few weeks ago?
  3. Did the Panel take the time to reconsider all the public comment? Or did they simply read the new ones?
  4. Whatever is in the final report, how can we be sure it is the best version that would have resulted if ODP had not screwed up the public comment process to begin with?

The mishandling of public comments is not a technicality, nor is it an insignificant matter. This goes to the heart of NIH’s stewardship of a process that depends upon the opinions of five people who have no expertise in ME/CFS. The federal government cannot play fast and loose with public comment, no matter what that final report looks like.

On April 19th, I sent a letter to the Office of the Inspector General for the Department of Health and Human Services to request an investigation and intervention to remedy the problem. After describing the facts of the situation, I wrote:

ODP’s failure to forward over 200 pages of public comment to the P2P panel for consideration is a clear violation of the public trust, NIH’s document retention policies, and public comment administrative procedures. The proposed “fix” of asking the panel “to consider the new information and determine if changes are needed before the release of the final report” is completely inadequate.

The purpose of collecting public comment is for the panel to have the benefit of outside views. By design, the P2P process selects non-subject matter experts for the panel. In order to produce useful recommendations on the future needs of ME/CFS research, the panel is completely dependent on the multi-component process of presenting evidence, particularly the public comment submitted on the draft report.

However, the success of the process requires that all public comments on the P2P report be considered equally. They should be compared and contrasted, and given equal weight. By failing to provide the Panel with all of the comments at the same time, NIH has created a situation in which the missing comments will automatically be considered differently than the comments sent to the Panel in January. This error is only compounded by the apparent failure to find all of the misplaced comments and produce them under FOIA. Finally, only two weeks elapsed between ODP’s acknowledgement of its failure to provide the comments to the panel and the announcement of the new publication date. It remains unknown whether the panel has received all the comments, how much time they have had to review the comments, and whether all the comments have been given the same level of scrutiny and consideration.

Given ODP’s admission that the panel did not receive all of the public comment, the very legitimacy of the P2P process and final report is undermined. This report is highly relevant to the planning and conduct of future ME/CFS research at NIH. There is a strong public interest in ensuring that NIH takes every appropriate corrective step, and that new procedures are in place to prevent the repetition of these errors.

Therefore, I ask that your office investigate the handling of public comment by ODP. I further ask that you act immediately to intervene, given the imminent publication of the panel’s final report. The report should not be published until the panel has received and given due consideration to every single comment submitted by the public in response to NIH’s invitation.

I will keep you posted on the status of my FOIA appeal and on any reply I receive from the OIG.

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