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.

Posted in Advocacy | Tagged , , , , , , , , , , | 10 Comments

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.

Comments are welcome and can be sent to I will do my best to respond.

Posted in Advocacy, Commentary, Occupying, Research | Tagged , , , , , , , , , , , , , , , , , , , , , , , , , | 14 Comments

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…


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:


#Chronicfatigue is real, and women are 2–4x more likely than men to be diagnosed with it.  #MECFS

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

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

We must stop playing “whack-a-mole”.

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

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

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

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

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

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

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

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

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

The IOM report suggested the:

Designation of an HHS Point Person

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

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

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CFSAC Goings and Comings

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

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

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

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

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

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

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

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P2P Missteps Continue

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

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

There are several possibilities:

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

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

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

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

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

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

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

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

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

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

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

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Alone in the Woods

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.

Posted in Occupying | Tagged , , , , , | 27 Comments

Grief: Words Fail

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

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

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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