Awareness Reboot

Posted on May 5, 2015 by Jennie Spotila

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

Posted on April 27, 2015 by Jennie Spotila

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

Posted on April 20, 2015 by Jennie Spotila

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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Alone in the Woods

Posted on April 13, 2015 by Jennie Spotila

I’m happy to share this guest post from Joe Landson. Man, can I relate to this!

Each of us patients has that one dear relative, friend, or acquaintance – the one who tells us, repeatedly, that we can do anything we set our minds to. He may cite examples of others who have overcome disability. She may use pop psychology jargon, or the homespun wisdom of Dr. Sw— um, Phil. And being the good people we are, we want to hold this lovely person tight – preferably with both hands, around his or her throat. (Just until the haranguing stops, of course.)

Whenever I confront advice like this, I remember a story I saw on television decades ago that somehow stuck with me. It was about a man who believed he could do anything he set out to do. (And he did.) This guy had two hobbies: marksmanship and wildlife photography. No, there were no telephoto lenses from a safe distance for him; he used a cheap, zoom-less film camera to photograph wild animals from a few feet away. Of course, he knew his hobby had some associated risk, so he always carried a powerful handgun on his photo trips.

grizzly5One day, this man set out to capture images of the most elusive and dangerous quarry in North America – a mama grizzly bear with cubs. And he succeeded. We know he succeeded because the pictures survived. (And beautiful close-up pictures they were.) The search party recovered the film from his camera, found more-or-less intact on the forest floor. A short distance away from the camera, they also found his pistol – fully loaded, hammer back, unfired. And the searchers found him. I forget if he was near the camera, or near the unfired magnum revolver. Or perhaps a bit of both?

Of course, the moral of this story is that our well-meaning friends are right, or at least half-right: You can indeed do anything you set your mind to. You can do it once. In the photographer’s case, he never did anything again. In our case, we face days, weeks, and months of recovery from most anything we do.

Some of us find this disease – wait for it – unbearable. Yet each of us probably tries to do something within our limits, while surrounded (or abandoned) by folks who really don’t understand what it costs us. On any given day, we can look and act healthy; but we can’t count on faking healthy the next day, let alone day after day. Our days are not replicable.

The miracle of Laura Hillenbrand is not that she wrote a brilliant, critically and commercially successful work of non-fiction. The miracle is that she did it twice, and lived to tell about it. (At this moment, Dear Friend is gearing up to ask why we can’t all be like Laura Hillenbrand.) However, just as she is not our bitch, Ms. Hillenbrand is not our cookie-cutter model for self-improvement.

The only limits we can set are our own, each of us, ourselves. If government doesn’t like that answer, then they can fund research of our disease properly. If organized medicine doesn’t like it, then it needs to adopt us into a specialty, and take responsibility for standardizing and organizing research inquiry into us. (And no, the shoddy PACE trial doesn’t count.) If our Dear Friends don’t like it, then they can break open their piggy banks, and fund development of an objective medical test that measures, reliably and exactly, how disabled we are. (The two-day exercise test arguably does this, but at the cost of the weeks of recovery we are trying to avoid.)

Until these things happen, we are each of us alone in the woods, facing our own grizzly. Some days, playing dead is the only play there is.

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Grief: Words Fail

Posted on April 8, 2015 by Jennie Spotila

blackboxThere are a lot of things to say about grief, and I had a much longer post planned for today. But words fail me on this. And as a person whose only outlet is words (as opposed to work, socializing, or physical activity), this is particularly frustrating. Here’s what I know, eleven weeks into this process:

Grief is not what you expect. Mom was one of my best friends. I talked to her every day. I helped take care of her for the last two years. I can’t imagine anything that could have improved our relationship, with the exception of better health that would have allowed us to do more things together. I could not see past the moment of her death. How could the world keep going, how could I exist, once she was gone? But the world is going and I exist, and this surprises me every day.

Grief is physical. I don’t mean in the stab-in-the-gut way when I miss her, although that happens too. I mean that I have not physically recovered from this loss. Mom died eleven weeks ago, and I am not back to Normal Shitty Baseline.* I am on the verge of crashing every day. I am not thinking clearly. My temper is short. I have trouble completing tasks and my memory is shot. I’m having trouble separating what is disease process and what is grief process. Even at Normal Shitty Baseline I have days when I can’t get out of bed or cook dinner or a thousand other basic things. What is normal in grief, when your normal is already shitty?

Acting normal is expensive. I look and sound normal (normal for me, anyway), but at great cost. Yes, I’ve been writing blog posts. But you don’t see how difficult it is, how writing these posts takes every bit of energy I have, and more. I’m running on the fumes of my fumes, at this point. Every single email I answer, ever document I read, every paragraph I write – it takes so much more effort and determination than before. I don’t usually talk about how hard it is for me to participate in advocacy, and I’m not even showing you the full cost now. The best analogy is that it feels like I’m hooked up to multiple IV lines, but the energy is running out rather than saline running in.

I’ve discussed all this with my doctors, and been reassured that this is “normal grief.” I am lucky that I have no regrets, and I don’t mind paying the price of grief for the happiness of my relationship with Mom. We have a close family, and everyone is supporting each other. I’m just trying to stay in the moment, ride the waves of emotions and be gentle with myself.

 

*”Normal Shitty Baseline” was coined by Trina Berne, and it’s the best description ever.

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P2P Mistrial

Posted on April 3, 2015 by Jennie Spotila

Yesterday, the following notice appeared on the P2P ME/CFS website in a red box:

Important Notice: The ODP recently discovered that one set of public comments was not forwarded to the panel for consideration. Because the ODP is committed to ensuring that all public comments have been considered, we have paused the publication process in order to give the panel time to consider the new information and determine if changes are needed before the release of the final report. Once the panel has been able to deliberate, the publication process will resume, and the ODP will announce a new timeline on our website. (emphasis added)

First, let me acknowledge NIH’s public admission of the gross negligence I pointed out in my FOIA appeal. It is never easy to admit that you messed up. And I appreciate NIH trying to remedy the problem. However, this proposed fix is completely inadequate.

Public comments on the P2P report should be considered equally. They should be compared and contrasted, and given equal weight. By failing – through some kind of monumental mistake – to provide the Panel with ALL of the comments at the same time, the missing comments will automatically be considered differently than the comments sent to the Panel in January.

For example, imagine you are a scientist and you’ve written up a recent set of experiments for publication. You’ve finished the Results and Discussion sections; you’ve completed your figures and tables. Then, at the last minute, someone points out to you that you failed to include a large chunk of data in the paper. Do you look at the missing data to see if it changes your paper at all? Or do you rewrite the paper, with the data now included?

Or, since NIH is so fond of the jury analogy for P2P, imagine this jury trial. The jury has deliberated and is about to come into the courtroom to announce their verdict. The judge stops them and says, “We failed to present testimony from a number of witnesses. We don’t have time to do that the usual way, with cross-examination and so on. So just read their statements and see if it changes your mind.” A mistrial would be declared so fast you would get windburn.

The whole point of public comment is for the Panel to have the benefit of outside views on their draft report. The process is designed to give the Panel time to consider ALL the public comment TOGETHER, before revising their draft report. Instead, NIH is now trying to close the barn door after the horses by asking the Panel to read these comments and see if it changes anything in their report.

Here is what I think NIH should do to remedy the situation:

  1. Reconvene the Panel in person. Provide them with all the public comment. Provide them with the IOM report. Ask them to review all of that information and revise their report again. That is the only fair way to treat those comments that NIH failed to send the Panel in the first place.
  2. Undertake an audit of the P2P process and staff. This is a monumental screw up (believe me, I’m using much stronger language in my head). There is absolutely no excuse for “misplacing” half of the public comment submitted on this report. It’s even more outrageous because it appears that the comments from HHS’s own advisory committee were among those misplaced. How is this possible!? In the real world, this is the kind of thing that gets you fired. And it’s only one problem among the many that we have uncovered in the P2P operation. NIH needs to audit the Office of Disease Prevention, and establish who is responsible for this string of bad decisions and poor performance.

Do not make the mistake of thinking all this is a technicality. Failure to provide the Panel with all of the public comment when they revised their report undermines the validity of the report. ODP is obliged to handle the public comment fairly. They failed to do so in the most basic, fundamental way.

CFSAC and Mass CFIDS and Mary Dimmock and all the rest of you who submitted such great comments deserve a full and fair hearing. NIH is still not giving that to you, despite it’s supposed commitment to do so.

 

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Assessing Outcomes

Posted on March 31, 2015 by Jennie Spotila

COAThe IOM, P2P and AHRQ reports all pointed out a serious gap in ME/CFS research: the absence of validated ways of assessing clinical outcomes. I have new information about an initiative to change that, and I’ll be speaking about my experiences as an ME/CFS patient representative at an FDA public meeting tomorrow.

How do you know if a treatment is working? How do you know if your disease is getting better or worse? As an individual, this is something to discuss with your healthcare provider. But in the context of a research study or a clinical trial, we need ways to assess this systematically. One way to do this is with a clinical outcomes assessment tool.

Clinical outcomes assessment (or COA) measures changes in how a patient feels or functions, and can be based on patient report, clinician assessment, or similar measures. It is different from a biomarker, which is an objective physical measurement. A COA can be a questionnaire or a measure of performance, and it has to measure something that matters (like a symptom or ability to function). This is really important for FDA because there has to be a way to prove a treatment is working.

But you can’t just pick a random set of questions and start using it, and expect FDA to accept it. FDA has a whole process of COA qualification. And it can be expensive to do the necessary research to prove that your questionnaire measures what you want in the patients who will use it.

After the April 2013 FDA meeting on Patient Focused Drug Development in ME/CFS, FDA took steps to address the need for a qualified COA in ME/CFS. FDA convened an ME/CFS Outcomes Measures Working Group comprised of representatives from FDA, NIH, CDC, and academia. Last year, I joined this group in the capacity of patient representative. While FDA is not developing the COA itself, the Working Group is collaborating on a proposal for funding to conduct the necessary research.

While I can’t share specifics about the proposal at this point in time, I can share my impressions from working with the group. First of all, I think it is fair to say that FDA is highly motivated to make progress on ME/CFS. The agency is not developing the COA tool itself, but they really want to help make it happen. Second, I have been able to participate as an equal member in the Working Group and in sidebar conversations. I have been treated as an equal, and my perspective as a patient has been sought out by the proposal team. Even better, my experiences as a patient have had an impact on the group’s work. This is a group that is open to data and information, and opinions shift as a result.

I have not often had the experience of feeling heard by government employees. This is why I applied for the FDA’s Patient Representative program in the first place: to make sure FDA hears the perspectives of ME/CFS patients whenever possible. It has been rewarding to share my experiences with a group actively working to create a COA for use in ME/CFS research and drug development.

If you would like to learn more about COAs and how FDA plans to incorporate patient voices in the process, you can watch an all-day public meeting on Wednesday, April 1, 2015. I have been invited to participate in the last panel of the meeting on the patient perspective on how to move forward. I’m not able to travel to Maryland for the meeting, so will be speaking by webcast.

 

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This Week in Virology Covers ME/CFS

Posted on March 29, 2015 by Jennie Spotila

You may remember This Week in Virology (TWiV) from their XMRV coverage several years ago. I’ve remained an avid listener of the show, simply because it is such a great ongoing conversation about science. And TWiV has continued its coverage of ME/CFS, most recently in discussing Dr. Ian Lipkin’s latest paper and the IOM report.

I was fortunate enough to meet the show’s host, Dr. Vincent Racaniello, in 2011, and have corresponded with him since. So after TWiV discussed Lipkin’s paper, I wrote in, and then they read and discussed my letter. For ease of listening and sharing, I’m gathering the whole sequence here. UPDATED March 30, 2015 with transcript and follow up letter.

TWiV Episode 329: discussion of the Lipkin paper and the IOM report occurs at approximately between 11:15 and 25:10 in the episode.

I wrote the following lengthy email to the show afterwards:

Dear Vincent and friends,

I’m sure you have received other emails regarding your discussion on Episode 329 about ME/CFS and Dr. Lipkin’s latest paper, but as a long time fan of the show who has lived with ME/CFS for more than twenty years, I could not resist chiming in with my two cents.

Dickson commented that patients with CFS are self-diagnosed, going to doctors who are prone to believing their symptoms. For the vast majority of patients, this is not true. The IOM report said that 800,000 to 2.5 million Americans may have this disease, but that 80-90% of them are undiagnosed. I have never met an ME/CFS patient who easily found doctors to believe them. Every single one of us has been dismissed or even ridiculed by one or more doctors. We’ve been told that we are lazy malingerers, that we have psychological problems, or that we just need to reduce stress. It is simply not the case that people “feel lousy,” as Dickson put it, go to the doctor, and come home with the CFS label.

As Alan noted, there is no doubt that the controversy over case definition has hindered progress in this field. Dickson was right to ask how many diseases are really included in an ME/CFS population, and he pointed out that absent an objective test, conclusions are preliminary. The IOM made recommendations to address that. First, the SEID criteria are no longer a diagnosis of exclusion. If a patient fits the criteria, then he or she should be diagnosed with the disease. The onus is put on physicians to make differential diagnoses, and physician education will be of critical importance if these recommendations are to succeed. Second, the IOM explicitly stated that their recommendations were based on current evidence and should be revisited in no more than five years. They anticipated that new evidence, such as Dr. Lipkin’s paper or the studies demonstrating brain inflammation, would change our understanding of the disease’s pathogenesis and perhaps validate biomarkers for diagnosis.

The Lancet editorial stated that the IOM was heavily and negatively lobbied for undertaking this study, but failed to acknowledge that there were legitimate scientific and political reasons for this opposition. First, at the time this study commenced, the IOM had never produced a disease case definition. There was no guarantee how many ME/CFS experts would be appointed to the panel, and the community feared this “definition by committee” would be created by people who knew nothing about the disease. Second, the ME/CFS field has upwards of twenty proposed definitions, so spending one million dollars to create the twenty-first seemed like a questionable strategy. Third, given the IOM’s prestige, we knew that we would likely be stuck with the results for a long time, and if the case definition was flawed then this would have long-term negative consequences. Fourth, the Department of Health and Human Services pursued this IOM study in secret. No ME/CFS experts were consulted about it, and the Department’s own CFS Advisory Committee was not informed of the plan. ME/CFS advocates discovered the contract by accident, and HHS completed the deal over the vociferous objections of advocates and researchers alike.

All that being said, it is not true that the entire ME/CFS community continued to negatively lobby the IOM after the study began. Certainly, some advocates did so and have continued to object (and not without reason). But many advocates, myself included, gave presentations to the IOM panel and provided written input. In fact, the public access file for the study, which contains all of the written materials submitted to the panel, totals over 5,500 pages. In my opinion, there is ample evidence that the panel listened to this public input.

The Lancet editorial also mentioned the PACE trial and the Cochrane review on exercise therapy. This brings me back to Dickson’s question about how many diseases are lumped together in the CFS category. Depending on the case definition being used, it could be more than one. The Oxford CFS definition, in particular, is overly broad, as it requires only six months of subjective fatigue. A patient population defined by only that subjective symptom is larger and less precise than a more narrow definition like the IOM SEID or the Canadian Consensus Criteria. In fact, a recent report from an NIH panel and a systematic evidence review by the Agency for Healthcare Research and Quality both recommend that the Oxford definition be retired because results from studies of this broad group cannot be accurately applied to the more specific ME/CFS group. This is important, because most of the studies in the Cochrane review on exercise in CFS were Oxford studies. The PACE trial also used the Oxford definition to enroll subjects. In fact, most of the studies purported to show that exercise is beneficial for patients with CFS have used the Oxford definition. In contrast, there is a growing body of work, such as this paper by Keller et al, showing that ME/CFS patients (defined more narrowly than Oxford) have measurable abnormal responses to exertion. The case definitions are not interchangeable, and research results should not be extrapolated from one group to the other.

Patients with ME/CFS do not just “feel lousy.” This is a serious disease with serious consequences. I have been housebound, and sometimes bedbound, for more than twenty years. The most severely ill patients suffer from numerous neurological symptoms, including ataxia and allodynia. This disease costs our economy billions every year in lost productivity, and yet NIH spends only $5 million a year on research. Even Dr. Lipkin has stated publicly that his grant application was denied after a reviewer claimed biomedical research was unnecessary because ME/CFS is a psychological disorder. The IOM report is an exceptionally well-referenced document, and states unequivocally that this is not a psychological disorder. It is my fervent hope that we can leave that controversy behind, and move forward with rigorous, well-funded research into carefully characterized patients. This is the only way we will find treatments and get our lives back.

Thank you for continuing the conversation about this disease. Vincent, I also send you best wishes for your son’s recovery.

Cheers,
Jennie

On TWiV Episode 330, Dr. Dickson Despommier read my email and it was discussed at some length by the group. The discussion runs from 12:57 to 29:10, and the wonderful Russell Fleming has kindly provided me with a transcript of the discussion. As you can see, a few additional questions were raised, so I sent this follow-up email to TWiV:

Vincent,

Don’t feel obligated to read this email on air because I’m not trying to monopolize discussion, but I want to answer a couple questions raised during the Episode 330 discussion of my letter re: ME/CFS.

Rich asked if I had a role in a CFS organization. When Vincent and I met, I was finishing my term as a member of the Board of Directors of the CFIDS Association (now called the Solve ME/CFS Initiative). Since the end of my term in 2011, I have not had a role in that or any other ME/CFS organization. Instead, I’ve focused my efforts on my blog, Occupy CFS, and on individual advocacy efforts.

Alan commented that giving more money to ME/CFS research means taking money away from another disease. It’s not that straightforward. I have documented that in FY2014, 62% of disease categories listed by NIH received an INCREASE in funding over FY2013. ME/CFS was one of only 17 disease categories out of 244 that received funding essentially flat with 2013. The remaining 31% of categories saw funding decrease. HHS employees frequently tell us there is no money, but that can’t be true if the majority of disease categories are seeing an increase in their funding. Since Alan mentioned HIV/AIDS, I checked their funding and found that HIV/AIDS research increased by $80 million from 2013 to 2014, and is projected to receive a $22 million increase in 2015. Couldn’t NIH reduce that to an increase of $15 million, and spend the other $7 million on ME/CFS? Both categories still go up, and ME/CFS’s budget would more than double. Obviously, there is money – it’s just not coming ME/CFS’s way.

There are several other things that could be done to increase ME/CFS research funding at NIH. ME/CFS does not have an Institute home. Instead, research is coordinated – with no budget and no dedicated program officer – through the Office of Research on Women’s Health. Setting aside the fact that men get ME/CFS too, this arrangement essentially means that ME/CFS research has to shake a tin can and try to get an Institute’s attention and interest. Moving the portfolio to one of the Institutes might help this situation. Second, NIH could issue an RFA with set aside funds for research into a high priority area such as large-scale validation of biomarkers, rigorous prevalence and epidemiology studies (to get at the “true case” question), and/or large -omics studies. NIH last issued an RFA for this disease in 2006, but has refused every subsequent recommendation and request to repeat the process.

Kathy asked how many non-ME/CFS experts served on the IOM panel. While the community feared there would be few or no experts, in the end the IOM appointed 8 members who had clinical, research, or personal experience with ME/CFS and 7 members who had none. The vast majority of the report’s peer reviewers had ME/CFS experience, as did every guest invited to present to the IOM panel at its public meetings. There were a diversity of views represented among those groups, but that is as it should be.

Alan rightly questioned my statement that HHS pursued this study in secret. I have accumulated documentation through personal communications with HHS employees and members of the CFS Advisory Committee, and through FOIA requests. HHS began working on the contract in early 2013, and employees were explicitly instructed not to share any information with the Advisory Committee or the public. HHS did publish notice of its intent to sole source the contract on a federal contract site on August 27, 2013, but made no announcement and never published the information in the Federal Register. Advocates discovered the posting and began an opposition effort, and the sole source contract was cancelled on September 4, 2013. No additional details were made public, despite repeated requests to HHS, until the September 23rd announcement of the contract signing as a Task Order under NIH’s standing contract with the National Academy, thus avoiding the requirement to give public notice of the specifics in advance. I made an attempt at summarizing the timeline, and why this approach was so disastrous for the HHS-community relationship, in this post just after the contract was signed.

On a more personal level, the most telling part of your discussion was Vincent’s statement that he was advised to avoid the CFS label for his son because then no doctor would do anything to help him. This happened to me. One infectious disease expert I consulted early in my illness said, “You have CFS but there’s nothing we can do for you. We can arrange for counseling to help you live with it. Maybe you’ll get better in five years.”  In fact, there are things patients can do to help alleviate or cope with symptoms, but there is no systematic way to access those treatments, and almost no ME/CFS specialists to consult. The conservative estimate is 800,000 people have ME/CFS (using the 1994 Fukuda case definition), and 80% have not been diagnosed. That means 640,000 have absolutely no help and nowhere to go because they don’t even know what they have. The other 160,000 who do have the label may have to wait months or years to access a specialist, or they give up and turn to alternative medicine, or their non-specialist doctors prescribe unproven therapies like antidepressants and exercise which could be dangerous to them. We cannot allow this to continue.

My thanks to all of you for covering this issue. Public dialogue like yours can only help.

Cheers,
Jennie

UPDATED April 5, 2015: My second email was read and discussed on Episode 331, along with emails from Steve, Claudia Goodell, and Mary Schweitzer.

My sincere thanks to Dr. Vincent Racaniello and the TWiV hosts for continuing the conversation about ME/CFS. They do great work. Listen to the podcast!

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Case Definition Bingo

Posted on March 23, 2015 by Jennie Spotila

bingoOur disease is plagued by too many case definitions, with the Institute of Medicine’s Systemic Exertion Intolerance Disease (SEID) being the most recent. Our federal agencies are thus far continuing the agnostic position of accepting whatever case definitions are proposed by researchers or drug sponsors. Communication from the IOM panel members has seemed contradictory at times regarding whether SEID replaces ME, or what to do with patients who do not meet SEID criteria. And advocates are arguing with each other over which definition is “right” and whether to support SEID. This includes some advocates claiming ME is not SEID, and that these two diseases should be kept separate.

This controversy gets to the heart of the IOM report, and the heart of its use and dissemination. It’s not possible to cover all aspects of this controversy in one blog post. Instead, I would like to come at it a different way. Rather than talk about the differences among these criteria, let’s consider the flip side problem of patients who meet more than one case definition. I’ll use myself as an example, and apply the major definitions. Then I’ll talk about a way to think about the muddle we’re in. For a nice overview of the definitions, see chapter 3 of the IOM report. Dr. Cindy Bateman also gave a great talk about SEID that explains some of the IOM Panel’s thinking behind the definition.

Oxford

Ha! Just kidding! You know what I think of the Oxford definition. Let’s move on.

Fukuda CFS

  • Prolonged or chronic fatigue that persists or relapses for ≥ 6 months
  • Four or more of the following concurrently present for ≥ 6 months: impaired memory or concentration; sore throat; tender cervical or axillary lymph nodes; muscle pain; multi-joint pain; new headaches; unrefreshing sleep; post-exertion malaise

When I was diagnosed in 1995, I met these criteria including having all eight of the ancillary symptoms (plus a number of others like dizziness, fevers, etc). Today, I have the fatigue plus impaired concentration, muscle pain, joint pain, unrefreshing sleep and PEM every day. I still occasionally get sore throats, headaches and tender lymph nodes (and dizziness, orthostatic intolerance, etc). So I meet the Fukuda definition.

One thing to keep in mind is that Fukuda draws a really big circle. At the P2P Workshop in December 2014, Dr. Luis Nacul presented data that show 163 different symptom combinations are possible under Fukuda. When PEM is required, that number drops to 35 combinations (still very high). There is no question that there are people who will meet Fukuda but will not meet IOM SEID or the ME definitions. Therefore, I am not arguing that Fukuda CFS is equivalent to CCC or ICC or SEID.

Canadian Consensus Criteria ME/CFS

  • Fatigue
  • Post-exertional malaise and/or fatigue
  • Sleep dysfunction
  • Pain
  • Two or more neurological/cognitive manifestations
  • At least one symptom from two of the following categories: Autonomic; Neuroendocrine; Immune
  • Illness lasting ≥ 6 months

Yes to fatigue, PEM, sleep dysfunction, pain, neurocognitive (such as confusion, concentration/memory, disorientation, info processing, word retrieval, overload phenomena), autonomic (such as POTS, lightheadedness nausea, IBS), neuroendocrine (such as feverishness, temperature intolerance, loss of adaptability), immune (such as sore throat, flu like symptoms, tender lymph nodes), and obviously I meet the 6 month requirement (with an extra 20 years to boot). So I easily meet the Canadian Criteria.

International Consensus Criteria ME

  • Post-exertional neuroimmune exhaustion (PENE)
  • At least one symptom from three of the following four neurological impairment categories: Neurocognitive impairments; Pain; Sleep disturbance; Neurosensory, perceptual and motor disturbances
  • Immune, gastro-intestinal and genitourinary impairments. At least one symptom from three of the following five categories: Flu-like symptoms; Susceptibility to viral infections with prolonged recovery periods; Gastro-intestinal tract; Genitourinary; Sensitivities to food, medications, odors or chemicals
  • At least one symptom from energy production/transportation impairments: Cardiovascular; Respiratory; Loss of thermostatic stability; Intolerance of extremes of
    temperature

I clearly have PENE according to the definition in the ICC paper, at the moderate (mostly housebound) level with occasional severe (bedbound) episodes. For the neurological impairments, I have difficulty processing information and short-term memory loss, headaches and significant widespread pain, unrefreshing sleep and disturbed sleep patterns, and I have the sensory and motor disturbances.

For the immune impairments category, I have flu-like symptoms, nausea/IBS, and sensitivity to medications and odors. In energy production, I have orthostatic intolerance, dizziness, air hunger, recurring feverishness, and temperature intolerance. So I easily meet the ICC definition.

IOM SEID

  • A substantial reduction or impairment in the ability to engage in pre-illness levels of occupational, educational, social, or personal activities, that persists for more than 6 months and is accompanied by fatigue, which is often profound, is of new or definite onset (not lifelong), is not the result of ongoing excessive exertion, and is not substantially alleviated by rest,
  • Post-exertional malaise, and
  • Unrefreshing sleep
  • At least one of the two following manifestations is also required: Cognitive impairment or Orthostatic intolerance

Importantly, these symptoms must be present at least half the time, and with at least moderate intensity. This is not a bad night’s sleep or minor forgetfulness. Not surprisingly, my doctor confirmed at my last office visit that I clearly meet the IOM SEID criteria, too.

So, Do I Get Bingo?

Where does that leave me? I meet criteria for Fukuda CFS, CCC ME/CFS, ICC ME and IOM SEID. You tell me: do I have one disease or four diseases?

This is the problem confronting all the advocates who are claiming that SEID is not ME. Many patients, like me, will meet the criteria for both. And when this point is raised in discussion, some people have suggested that there are two separate diseases. But if you follow that idea to its logical conclusion, two diseases means two different revenue streams for NIH funding. It also means a drug approved for one disease will need to be approved for the second disease.

If we are talking purely about case definitions, as opposed to real people, then yes ME is absolutely not SEID because the ICC and IOM SEID are different criteria. ICC requires more symptom categories, and specifies the symptom manifestations in each category. And neither ICC ME nor IOM SEID are Fukuda CFS. Dr. Lenny Jason’s most recent paper is just one illustration of that. So if we are purely talking about the definitions – the separate descriptions of requirements for diagnosis – then I think it is logical and clear that ME is not SEID is not CFS.

But that’s not the only context for discussion. Case definitions are hypothetical until they are applied to real people. And when you apply those four definitions to me, I meet them all. This does not mean I have four diseases. It means that these four definitions each describe the disease that I have. Do you see the distinction?

That is the crux of the matter. This thing, this disease that we have, the disease we described to FDA, the disease we can recognize in each other in about five minutes – this thing has been described (with varying degrees of success) by all four criteria. Fukuda CFS is clearly the broadest and least useful definition. Fukuda allows too many combinations of symptoms, and only a fraction of those include PEM. Therefore, it is possible to meet Fukuda and not meet IOM SEID, and what to do with those patients is a quandary for another discussion.

But to claim that IOM SEID is not ICC ME is not CCC ME/CFS is true only in the literal sense that these criteria do not use the same words to describe the disease state that I have, and that many of my readers have. It may be possible to meet one of these descriptions and not another, but that does not automatically mean we all have different diseases, especially when the overlaps among those descriptions seem so large.

I have one disease. That disease has been described in different ways by different groups. The intersection of those descriptions and our experiences as patients must be studied. We need data to understand the characteristics of the patient populations identified by each definition. There will likely be substantial overlap – but is there a biomarker that unites us? Are there subtypes that distinguish us? Is one description demonstrably more sensitive and specific than the others? Did IOM SEID successfully pare down to the most essential elements of the disease, or did they strip out too much?

I have one disease. That disease has been described in different ways. I want my disease to be researched so that the less accurate and less useful descriptions can be retired.

Bingo.

Posted in Advocacy, Commentary | Tagged , , , , , , , , , , , , , | 40 Comments

Did P2P Receive Your Comments?

Posted on March 17, 2015 by Jennie Spotila

missingpagesThe P2P report is scheduled to be published on April 14, 2015, but new information may call the legitimacy of the report into question. Based on NIH’s response to my FOIA request, I believe it is possible that the Office of Disease Prevention (ODP) never properly logged some of the public comments on the draft report – including the comments from the CFS Advisory Committee.

First, a brief review of the public comment issue. In early January, ODP told advocates that public comments on the P2P draft report would not be retained. Several advocates, including myself, filed FOIA requests for those comments. In the meantime, I offered to publish the comments of any advocate or organization who wished. The P2P Library is quite impressive, and a terrific example of the quality work of many advocates.

On February 27, 2015, NIH responded to my FOIA request with 308 pages of public comments. I knew there would be comments in the packet that I had not seen before, but I did not expect comments to be missing.

But that is exactly what I discovered. Dozens of comments that I know were submitted to the ODP were not included in the FOIA release. Here are three examples (although there are many more):

Why were these comments omitted from the FOIA release? I can think of two explanations. One possibility is that the FOIA office’s document search was grossly inadequate, and they missed dozens of comments collected by ODP. The second possibility is that ODP did not properly retain some of the comments submitted by the public, and therefore those documents were not available for the FOIA search and release.

If this second possibility is true, then the P2P panel never saw CFSAC’s comments, or the many other comments that we know were submitted on time. And if that is the case, then ODP breached its own policies, and the panel did not have the benefit of all those comments in revising the P2P report.

Throughout the P2P process, NIH has touted the public’s role of participating in the meeting and commenting on the report. Stakeholder participation improves the quality of the reports and helps the non-expert panel balance all sides in the final product. Now we must confront the possibility that reams of public comment on the draft report were lost, discarded, or otherwise went missing. How can we say that the April 14th report is, in fact, the best product of this process?

I have appealed the FOIA release, challenging the adequacy of the document search. If ODP has these comments, then a second search should capture them. I’ve also reached out to the P2P panel in an attempt to verify whether they received these missing comments. As always, I’ll let you know what I find out.

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