P2P: Where Next?

people-marchingThere is one official final step in the P2P process: a federal partners meeting supposed to be held six to eight months after the workshop. But there are other marching orders, too. For us.

Federals Only

As described on the P2P website, there is a federal partners meeting six to eight months after each workshop. The purpose of the partners meeting is to review the panel’s report and identify possible opportunities for collaboration. The key here is that it is federal partners only – no other stakeholders are invited as far as I can tell.

Only one P2P workshop has progressed to the partners meeting. The Polycycstic Ovary Syndrome (PCOS) federal partners meeting was held in May 2014, almost 18 months after the PCOS workshop. There is no list of attendees posted online, but a basic summary of the meeting is available. A number of ideas seem to have been tossed around, but no specific action items or commitments were made by the federal partners.

The takeaway is that the final P2P step is a meeting for federals only, without a track record of producing actions or commitments. For all the fuss and promotion around P2P, NIH seems rather uninterested in applying anything that comes out of the process.

The To Do List

But WE don’t have to take the same attitude. As I said in my post about the P2P report’s failures, there are good things in the report too. I have compiled a list of all the action items suggested by the Panel, and I think we should use it to check NIH’s progress at every opportunity.

You can see the full list here. I’ve included citations to the pages where these recommendations appear. The only changes I made were to make the phrasing active, rather than passive. The recommendations are listed in the order with which they appear in the document. I had hoped the Panel would explicitly prioritize their recommendations, but the order remained unchanged from the draft report. It is a very long list of action items: sixty-five in total. What it boils down to is this:

  1. Reach consensus among the stakeholders on a case definition.
  2. Prioritize biomedical research for biomarkers, pathogenesis, diagnostics, prognostics, and therapeutics, including -omics and imaging studies.
  3. Create a central repository/registry for biological samples and clinical data.
  4. Increase patient involvement in creating research priorities, patient-reported outcomes, and the case definition.
  5. Disseminate best practices and training to primary and specialty physicians.
  6. Create a network of centers to determine: biomarkers for diagnosis and prognosis; epidemiology; outcomes; cost-effectiveness; co-morbidities; recovery; and control populations.
  7. Convene an ME/CFS expert panel in five years to monitor progress.

Many of these items have been recommended by the CFS Advisory Committee and advocates many times before. This is a list that cannot be completed in five years, and which will never be completed without a very substantial increase in investment.

But a significant value of this list is that it gives us the structure for an NIH report card. We should, at every opportunity and in every possible venue, ask what progress is being made on the list. Print out that NIH report card and share the list with Congress, asking them to monitor NIH’s progress on this advice which, after all, NIH requested itself. Bring the list to every CFSAC and ask the NIH ex officio what progress is being made. Mark your calendar for June 2020, and demand that ODP reconvene an expert panel to monitor progress.

And if no progress is made? If NIH focuses on the cheap and easy recommendations? Then we wave this list and remind them that THEY requisitioned these recommendations, not us. These are not recommendations from the same crowd that has been making the same recommendations for twenty or thirty years.

Funding Funding Funding

Despite the Panel’s reluctance to explicitly recommend an increase in ME/CFS research funding, it is patently obvious that the necessary progress cannot be made on $5 million a year. We must continue our demands for increased NIH funding, especially because it looks like NIH might get a 6% increase in budget in FY2016. Much of those funds will go to “sexier” projects like precision medicine and the BRAIN initiative. But NIH cannot continue to claim there is simply no money.

So how do we go about pressuring NIH to increase its ME/CFS investment? There are several petitions in circulation, and ME Advocacy is running a one-click campaign. ME Action has a petition for more funding. There’s also an email campaign directed at NIH. But as with all advocacy efforts, make sure you read all the details before signing on. Some of these efforts explicitly reject the IOM report, others incorporate quotes from IOM and P2P reports in support of research. Know what you’re signing.

If you can’t find a petition or one-click campaign that fits your views, then consider starting your own. ME Action provides a platform with organizing tools for a variety of actions. And it bears repeating that contacting your own representatives is always a good idea. Congress may especially be interested in whether HHS takes any of the expensive advice they got from IOM and P2P.

Marching Orders

Here’s the bottom line: the P2P Panel recommended research priorities that will cost a lot of money to carry out. Many of the recommendations match what advocates have been saying for years. The only way to make progress is to significantly increase research funding for ME/CFS.

NIH controlled the P2P process. NIH selected the panel members, defined the questions, designed the evidence review and the workshop agenda. This has been NIH’s game, played by their rules. If NIH does not like the advice they got, or if this was all just a show never intended to go anywhere, then that just gives us even more political ammunition.

We must demand the necessary increase in funding. We must hold NIH accountable to the report card of recommendations. We’ve got our work cut out for us.

Let’s get going.

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Showing the Back of Their Heads

image credit: greggilbert.com

image credit: greggilbert.com

The final P2P report is published, and now it’s time to evaluate the quality of the recommendations and how well the process served ME/CFS patients. There are many good things in the P2P report, and I’ll be focusing on those in my next post (now available here). Today, I want to discuss some serious flaws in the report and how, despite all the rhetoric, NIH and the P2P Panel did not engage with the public in a meaningful way. And I also want to discuss a lesson we can apply next time.

All That Input

At the telebriefing on Tuesday, June 16th, Dr. Green said the Panel members individually reviewed each of the public comments and discussed them in a conference call. Unfortunately, the Panel did not take most of our advice. The Panelists may have reviewed each comment, but only minor changes were made to the draft report in response to those comments.

For example, the final report appropriately deleted the sentence, “There is no agreement from the research community on what needs to be studied.” (Draft, lines 34-35) The statement that ME/CFS “overlaps with many other diseases” was also deleted. (Draft, line 33) The need to disseminate diagnostic and treatment recommendations to primary care providers was expanded, as many public comments suggested, to include specialties like neurology, rheumatology and infectious disease. (Draft, line 192) Other minor corrections were made, such as clarifying that Fukuda allows 163 combinations of symptoms, not that there are 163 symptoms of ME/CFS. (Draft, lines 50-51)

But the vast majority of comments were ignored. Even the statement that ME/CFS has an economic impact greater than $1 billion (Draft, lines 6-7) was not fully corrected. I lost count of the number of public comments that provided the correct number of more than $20 billion in direct and indirect costs. However, the final version estimates the burden at $2 to 7 billion, and does not clarify whether those are direct or indirect costs. When journalist Miriam Tucker asked for the reference for this estimate, Dr. Green said they used a number that was “scientifically based,” but she did not provide a reference.

But these are minor points compared to the failure to incorporate the major issues highlighted in multiple public comments. All the input on the critical points that most need attention was ignored.

 The Money Elephant

The issue that receive more attention in public comment than any other was NIH funding. Comment after comment begged the Panel to acknowledge the paucity of funding and to recommend that NIH significantly increase its investment in ME/CFS research.

The IACFS/ME said, “[We] believe that the elephant in the room – research funding . . . needs to be addressed more strongly and specifically. . . . Thus we respectfully ask that the NIH Panel highlight the inadequate research funding of ME/CFS and link this core premise to specific recommendations for new funding initiatives, with dollar amounts, mechanisms, and deadlines, to begin to address the current underfunded status of this illness.”

The CFS Advisory Committee said, “We also ask that you take note of the fact that among the 234 disease categories supported by NIH in 2014, chronic fatigue syndrome ranked 228th with an estimated $5 million in funding. In order to move forward, it is vital that this issue be addressed. We ask that the Panel explicitly address the urgent need for government funding in order to advance the research for ME/CFS.”

The Massachussetts CFIDS/ME & FM Association said, “All of these recommendations for future directions in research require significant funding . . . NIH has never funded this illness commensurate with its impact on patients and society. While it may be possible to cobble together small amounts of funding from different agencies for some specific initiatives . . . why not just recognize the inequality here and deal with it? The types of research recommended here cannot be done on nickels and dimes.”

I could go on. Over and over and over, public comments begged the Panel to recommend an increase in NIH funding. If the Panel did indeed read the hundreds of pages of comments we submitted, they could not possibly have missed the blaring consensus on the urgent need to add zeroes to the amount of NIH’s ME/CFS investment. Despite all of this, the Panel made no such recommendation. I have no doubt that some people will conclude that NIH told the Panel they could not make the recommendation.

In fact, Dr. Green told Medscape News, “Money can be reallocated or better targeted.” That’s quite explicitly not an increase in funding, folks.

Eating the Oxford Cake

I blogged about the moment at the P2P Workshop when the Evidence Practice Center suggested retiring the Oxford definition, and the illogical reply to my question about retiring Oxford studies. Chris Heppner made a powerful case for declaring independence from the Oxford definition once and for all. But not only did the Panel’s final report fail to take that logical step, it actually toned down its language on the Oxford definition.

The draft report stated, “The Oxford criteria . . . are flawed and include people with other conditions, confounding the ability to interpret the science.” (Draft, lines 38-40) That sentence is gone from the final version. We are left with the recommendation from the Draft, unchanged in the final version: “Specifically, continuing to use the Oxford definition may impair progress and cause harm. Thus, for needed progress to occur, we recommend (1) that the Oxford definition be retired . . ” (Final, p. 16)

Personally, I am very disturbed by the deletion of the statement that Oxford includes people with other conditions. Why? Because the data establish that this is the case. The Panel should have retained their acknowledgement of the data. For the Panel to step back from acknowledging the facts strikes me as ominous, because obviously it helps ME/CFS advocates to have such an explicit declaration in the report and its removal makes no sense in light of the data. It will certainly raise questions in some minds about whether the Panel was pressured to remove the sentence.

I am also not satisfied with the recommendation to retire the Oxford definition without an accompanying recommendation to retire Oxford studies as applied to the ME/CFS population. Why? Because the largest trial of CBT and GET, the trial that is the basis for the claim that these therapies are effective treatments for ME/CFS, uses the Oxford definition. And that study is continually trotted out, including in the Annals treatment article this week, and no one will acknowledge the very basic logical fact that the study was done on a cohort that included an unknown number of people who did not meet criteria for ME/CFS (not Fukuda, not CCC, not ICC, and not SEID).

Multiple public comments, including mine, made this point to the Panel. The bottom line is, “You cannot take the results of studies done on subjects who do not have ME/CFS and simply apply those results to those that do.”

For some reason, the Panel did not agree with all of the comments making this point. Why? One possible reason is that if the PACE trial and similar Oxford “treatment” studies are discarded, then there is almost nothing left. This is especially true for the systematic evidence review, which excluded studies like the Rituximab trial. It would mean admitting that thirty years of research has not produced an effective treatment for ME/CFS, and that the only promising treatments are extraordinarily expensive. That’s a damning fact and quite an embarrassment for NIH and the research enterprise.

Not Our Wheelhouse

Multiple public comments urged the Panel to consider the IOM report while revising their recommendations. Even Dr. Nancy Lee, newly re-appointed DFO of the CFS Advisory Committee, asked them to discuss it.

Dr. Lee emailed her comments the day after the posting of the Draft Report. I think it’s worth quoting Dr. Lee at length: “To avoid the mistaken perception that NIH and the P2P Panel didn’t know about the IOM study (which NIH helped fund!), I urge you to mention the IOM study in your report. The discussion on lines 201-212 should be modified to acknowledge that the IOM’s report may make substantial progress in fulfilling P2P recommendation. There is a good chance that the IOM report will be released before the Panel’s report so you might even be able to modify your report at the last minute to reflect the content of the IOM’s report. HHS spent $1million on the IOM study to get much of what your panel recommends on line 202. I don’t want it to appear that NIH’s right hand doesn’t know what its left hand is doing!”

Despite the many requests, the Panel wrote that considering and incorporating the IOM’s recommendations was “beyond our scope and charge.” (Final, p. 18)

The charge to the P2P Panel was to provide “guidance to the NIH on research gaps and research priorities for ME/CFS.” (Final, p. 18) The final report notes the critical importance of case definition in ME/CFS research, and urges that a consensus be reached on a single case definition. (Final, pp. 9, 16) So how is the IOM report beyond the scope and charge of the P2P Panel?

I think the Panel members would agree that science requires examining all the data. My personal belief is that the phrase “beyond our scope and charge” is actually code for “we were not given the time and staff support to fully evaluate the IOM report.” Was it a matter of NIH putting its P2P process (evidence review + workshop = report) over the quality of the product? Was there some other reason NIH did not ask the Panel to review and consider the IOM report? I do not know.

Talking At The Back Of Their Heads

ignoreBy now, we are all familiar with the NIH party line that ME/CFS patients and advocates were fully engaged by P2P. At the telebriefing, Dr. Ronit Elk said that patients and families were “completely a part of the process.” I won’t review all the evidence to the contrary from the last 18 months.

What I will do is point out that the “tremendous number of responses,” as Dr. Elk described it, seems to have had very little impact on the revisions to the draft report. Despite the extra time given the Panel, despite Dr. Green’s statement that each panelist read every single comment, despite the assurances from NIH that patients and advocates were integrated at every step, our comments were not accepted.

Many advocates might think that the dismissal of these comments prove that public comment is a waste of time. We comment, they don’t listen to us, so why bother? I say that’s a response that plays right into the government’s hands. This defeatist reaction has it all backwards.

Over 100 people and organizations submitted comment on the P2P report, and they were ignored. That gives us another link in the Thirty Years of Neglect Chain. We can embarrass them with this fact. We can tell the media, our Congressmen, CFSAC, and others that over 100 people spoke and we were dismissed and ignored. That’s the level of contempt NIH has for our input.

Dialing back our participation is exactly what they want us to do. They want us to go away. They think that if they just keep ignoring us, we will get frustrated and lose interest.

We should do the opposite. We should say, You ignored 100 comments? Let’s see you ignore 200 or 500 or 1,000. The more comments that go in, and the more they ignore them, the more ridiculous the situation becomes. That is a political weapon!

So yes, 100+ comments was not enough to get a stronger recommendation on funding into this report. There is still plenty here we can use. And we have one more incident of Government Ignores Constructive Response From Patient Community to add to the list. They are practically begging us to turn up the volume and intensity.

NIH is showing us the back of their heads. Ok, then we have to be louder. NIH is ignoring us. Then let’s be more forceful. Let’s increase the volume, increase the intensity, and build an ever growing wave of actions that will ultimately overwhelm resistance and swamp them. They ignore us because they can. So let’s make it impossible for them to do so.

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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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