Jennie Spotila, CFSAC Testimony, December 2013

Posted on December 11, 2013 by Jennie Spotila

I submitted these comments in writing for the public record. However, given all that has transpired since then, I will not be delivering these remarks during my comment slot today.

The relationship between ME/CFS advocates and the federal government has never been very good, and there have certainly been many low points like the CDC misappropriation of funds in the 1990’s. But in the last two years, we’ve been on an increasingly slippery slope down to new depths.

  • When we asked for a national strategic plan, we were told HHS already had too many plans.
  • When we asked for the prioritized outcomes from the NIH State of the Knowledge meeting, we were told this would not be shared with the public.
  • When we asked for research funding commensurate with the burden of illness, we were told there are not enough grant applications.
  • When we asked for the CFS SEP rosters, we were told this information – public for every other NIH grant review panel – could not be released due to undisclosed security concerns.
  • When we said that the CDC multisite study should include 2 day CPET and natural killer cell function as candidate biomarkers, we were told financial and logistical constraints prevented the use of these tests.
  • When I requested documents regarding voting member appointments to CFSAC, I was told the Office of Women’s Health did not keep such records. Unsurprisingly, a FOIA request revealed just how much documentation is indeed kept.
  • This Committee has admitted to one violation of the Federal Advisory Committee Act, and I believe there may be more.

It’s not just members of the public who receive this kind of dismissive treatment. It’s the voting members of CFSAC, too:

  • When you asked at your last meeting for information on the planning of the NIH Evidence-based Methodology Workshop, NIH promised to release that information soon. It hasn’t happened.
  • When you asked to see a copy of the revised Toolkit before CDC releases it, CDC responded, “We don’t do that.”
  • When you recommended a meeting of ME/CFS experts and stakeholders to arrive at a single consensus definition for clinical and research use . . . well, we all know what happened with that.
  • When HHS planned their response to that recommendation – the contract with IOM – they intentionally kept you in the dark for months.

The dismissal, the stiff-arming, and the disrespect have accelerated even since the last meeting of this Committee.

  • Claiming budget cutbacks, this meeting is being held by webinar. I have looked and found no other advisory committee in the Assistant Secretary’s office that has done so. Only this Committee. Why? Is HHS that concerned about silent protests from patients? Is HHS that unconcerned about the Committee’s ability to interact with one another face to face, to have a free communication outside the official public sessions?
  • The IOM sole source solicitation was found by advocates, formally announced by CFSAC support staff, withdrawn, then a contract was pursued, finalized and announced again.
  • Protests from the scientific, medical and advocacy communities have been ignored so thoroughly for so many weeks that it’s as if federal employees have their fingers in their ears and are chanting “la la la la I can’t hear you.”
  • Eight weeks – eight WEEKS – after the IOM contract is signed, the CFSAC support staff issued an FAQ to address the community’s questions about the contract. Since I have less than five minutes remaining, I cannot even begin to pick apart the ways in which these proffered answers fail to answer anything at all, but have documented it here.

You might think that this is enough. You might think that I have no more complaints to lob at the government’s feet. But sadly, even the integrity of this Committee has been undermined.

  • The membership and expertise of this Committee has become increasingly unbalanced. FACA requires that members of this Committee have sufficient expertise related to ME/CFS, and that a balance of views and areas of experience be represented. Of the eleven voting members, there are eight clinicians and researchers, but only four have a substantial focus on ME/CFS.
  • The last three members appointed to the Committee, one of whom resigned after a single meeting, all nominated themselves and all live in the DC area. My FOIA requests have produced no supporting documentation beyond these members’ self-nomination letters – no recommendations from patients or advocates, not even references from colleagues or other CFSAC members.
  • At the May 2013 meeting, two members of this Committee publicly alleged that Dr. Lee attempted to intimidate them for expressing their points of view, possibly even remove them from this Committee. There was no reaction by the Committee’s leadership whatsoever. Therefore, we requested an investigation, and were then ignored for more than four months. When an answer finally came, Dr. Koh dismissed the entire thing as a confidential discussion about FACA rules. He said everyone should conduct themselves in a manner conducive to respectful and candid discussions, while ignoring the elephant in the room: the allegations that the DFO had done precisely the opposite.

These allegations and Dr. Koh’s failure to address them have undermined the credibility and integrity of this Committee. I do not see how the public can believe that any of you are voicing your honest opinions and advice when there is a cloud hanging over the DFO and at least two or three of your fellow members.

The Institute for Clinical Research Education at the University of Pittsburgh says, “Effective communication takes place only when the listener clearly understands the message that the speaker intended to send.” Many people believe that communication between HHS and the ME/CFS community is about as far from effective as we can get.

That is, unless HHS intends to send the message to the ME/CFS community and to you, CFSAC members, that it does not care what we think, it does not want our input, and it does not intend to do anything beyond or better than what it is already doing. That’s what I’m hearing. If HHS intended to send that message, then perhaps its communications are perfectly effective after all.

The further we go down the slippery slope of the deteriorating relationship between the government and the ME/CFS community, the faster we slide.  Advocates have not sat back, complaining about the government and this Committee without trying to improve things. I’ve personally participated in multiple efforts to engage with HHS staff, to calmly convey the advocacy point of view, and to suggest ways to improve the engagement and operation of this Committee. With a few minor exceptions, like the renewed acceptance of video testimony, those efforts have failed.

There are three overarching themes to ME/CFS advocacy on federal policy. The first is the demand that our disease be researched to the fullest extent. The second is the demand for clinical care tailored to this complex disease, not stamped with a one-exercise-program-fits-all approach. The third is the demand for transparency and accountability for what our government does.

HHS is failing on all three counts. CFSAC members, you can be part of the solution, or you are a part of that failure. There are no sidelines, here. There is no neutral ground. Not anymore.  I fear that things are too far gone for that.

 

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Sr. Sandra Duma, CFSAC Testimony, December 2013

Posted on December 11, 2013 by Jennie Spotila

Sr. Sandra Duma was scheduled to give her first ever CFSAC public comment yesterday, and like all the other Tuesday slots hers was unilaterally cancelled when Dr. Lee decided to dispense with the first day of the meeting. I’m happy to publish her comments in their entirety.

A few weeks ago I pulled out some ME/CFS videos purchased over the years and once again watched one called “Living Hell.”  This was a documentary produced by Authentic Pictures in association with the CFIDS Foundation of San Francisco.  I looked at the jacket to see that this excellent film came out in 1993 – 20 YEARS AGO.  That film might just as well have been made yesterday.  The governmental issues and lack of response are the same ones ME/CFS patients face today.  20 YEARS LATER, and nothing has changed.

During all this time, no significant recommendations made by CFSAC that could affect the course of this disease in patients’ lives have ever been implemented.  HHS, NIH, and CDC have not provided the necessary leadership, resolve, and financial resources needed to tackle this disease.  HHS, NIH, and CDC are fiddling while Rome is burning.  This disease is spreading as more and more people around the world are becoming disabled by it.  Isn’t anyone in the government concerned and asking why?

In the absence of this leadership, expert ME/CFS researchers and clinicians from around the world have produced two excellent ME/CFS or ME definitions that reflect the experience and knowledge they gained by working with thousands of ME/CFS patients over many years.  These definitions are the Canadian Consensus Criteria (CCC) and the ME International Consensus Criteria.  Patients around the world see themselves and their illness experiences reflected in these definitions.  Patients heartily support these definitions and are greatly concerned that efforts now being made by HHS with their IOM contract will undo the work of these experts and set us back for years to come.

A critical question — Is the purpose of this IOM contract to ratify and promulgate the work of these ME/CFS experts, or to squelch it in order to regain control over the situation by putting ME/CFS back into the Pandora’s box of nebulous, waste-basket, meaningless “chronic fatigue syndrome”?  Another critical question — Is journalist Llewellyn King’s observation that low-cost psychiatric treatment is favored over higher-cost internal medicine treatment the driving force behind this IOM contract?

There are currently three petitions on the internet calling for the adoption of the CCC in the United States or to thank the 35 (now 50) ME/CFS experts who sent a letter to Secretary Sebelius announcing that they had reached consensus on the use of the CCC as the sole definition for ME/CFS.  Patients around the world are very concerned and are watching closely as their lives too will be affected by these decisions.  I have kept track of the countries represented by these patient signatories.  I may have missed some, but these are the 44 countries I have seen on these petitions:

 

Afghanistan                          Ireland                                   Slovenia

Argentina                               Israel                                      South Africa

Australia                                Italy                                         Spain

Belgium                                 Lebanon                                Sri Lanka

Bulgaria                                 Malta                                      Sweden

Canada                                 Mexico                                    Switzerland

Costa Rica                            Netherlands                         Thailand

Croatia                                   New Zealand                                    Turkey

Denmark                               Norway                                  Turks and Caicos

Finland                                  Portugal                                 United Arab Emirates

France                                   Poland                                   United Kingdom

Germany                               Romania                               United States

Greece                                   Russia                                   US Virgin Islands

Iceland                                   Saudi Arabia                         Zimbabwe

India                                       Singapore

 

Patients are terrified that once again, with this IOM contract, our disease, the disease that showed up in Incline Village, Nevada, will be defined out of existence and made to disappear.  And with that, will go all hope that we will ever receive the recognition and help so desperately needed for a disease that has stolen our very lives.

We won’t get answers as to why more and more people are becoming disabled from this disease by sweeping it under the carpet with an overly broad, all encompassing, meaningless definition, and tagging onto it a trivializing and demeaning name.  Recognize this disease for what it truly is – an organic complex neuro-endocrine-immune disease with multi-system involvement and energy production problems, with post-exertional malaise as its most distinctive characteristic.

For much too long, the emphasis on “fatigue” and “fatiguing illnesses” has led us down a wrong path and wasted years of our lives.  Cognitive behavioral therapy and graded exercise therapy are NOT the answers or effective treatments for this complex disease.  To get answers and effective treatments, we need good research, and good research depends upon a good definition that actually reflects the experience of the patients suffering from it, not some construct in the minds of the powers-that-be who may want a simple and low cost solution to a complex, organic, multi-systemic, very debilitating, life-robbing disease.

Our lives are hanging by a thread, waiting, waiting, waiting for your effective response to this devastating problem.

 

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Mary Dimmock, CFSAC Testimony, December 2013

Posted on December 10, 2013 by Jennie Spotila

Mary Dimmock had a comment slot for Tuesday, and like all the other Tuesday slots hers was unilaterally cancelled when Dr. Lee decided to dispense with the first day of the meeting. did not receive a public comment slot. I’m happy to publish her comments in their entirety.

Good afternoon. Thank you for giving me time to speak today.

I will address just two of the many issues that ME patients face – HHS’ failure to focus on the disease the patients actually have and HHS’ failure to effectively engage the ME community.

At the last CFSAC, Dr. Unger questioned the nature of post-exertional malaise. She also questioned its significance as a hallmark symptom, rhetorically asking “If a patient doesn’t have [PEM], wouldn’t you still manage them as a “CFS” patient?”

When I heard that, I wanted to scream. That single exchange highlights what is so rotten with HHS policy toward ME. From its earliest response in 1984 to its actions today, HHS has either utterly misunderstood or willfully ignored the neuroimmune disease with its hallmark PEM that patients actually have.

Instead, HHS has wasted decades and countless millions fixated on studying medically unexplained fatiguing illnesses under the rubric of “CFS”, a man-made clinical entity that in reality is an unscientific hodgepodge of biologically unrelated conditions. A black hole guaranteed to insure that any disease in the CFS grip will remain forever medically unexplained and mistreated.

Now HHS wants us to take a leap of faith that their IOM contract will fix the chaos that HHS definitions have caused.

To which I ask one simple question. What disease are these new criteria going to describe? The disease that the Canadian Consensus Criteria describes? Or will the new criteria describe the range of diverse medically unexplained fatiguing conditions encompassed by CFS criteria.

According to Dr. Lee and IOM’s Kate Meck, no decision has been made on this fundamental question yet. That is stunning. This is a million dollar contract and the panel has already been named. Who will make this decision and on what basis? Will the panel still be the appropriate one once the decision is made? But I was much more concerned when in response to my question, Dr. Lee never said that this new criteria was intended to specifically describe ME. Instead, she emphasized establishing ME as a subgroup of the broader CFS or maybe ME as part of a spectrum of CFS illnesses. She also said that for the sake of primary care physicians, it was better to start broad and define subgroups.

Are you kidding me? Where is the scientific proof that this collection of medically unexplained fatiguing conditions called CFS is a valid clinical entity to begin with? Where is the scientific justification to treat ME as a subgroup of this bogus entity? How many more papers does Dr. Jason need to publish to convince you that this is scientific lunacy?

HHS needs to listen to the experts, to the patients and to the evidence. HHS needs to explicitly and immediately acknowledge that the disease described by the Canadian with its hallmark PEM is completely separate from the broader collection of medically unexplained fatiguing illnesses. HHS needs to put up a black box warning against exercise for these patients as suggested at the last CFSAC. HHS needs to follow the lead of experts and point clinicians to the CCC. And HHS needs to require that all NIH funded research incorporate the CCC.

But HHS won’t do that. Which brings me to my second point – HHS’ failure to engage the ME community as key stakeholders.

Case in point – the IOM contract. A microcosm of failed engagement. We all know where the disease experts and patients stand on the definition and what the CFSAC recommendation said. So what does HHS do? It ignores all of that and instead unilaterally defines its own initiatives to create its own criteria for some vaguely defined and non-specific condition. Using non-experts. Spending 18 months and 1 million dollars redoing what the experts have already done and recommended. You even had the temerity to reject the Canadian Consensus Criteria because it doesn’t incorporate evidence since 2003 while you steadfastly refuse to accept this same evidence when it comes to PEM and CPET.

Other examples of failed engagement? Take Dr. Koh’s disingenuous and off-point response to the ME community’s request to investigate allegations of intimidation of CFSAC members by the designated federal official.

Or patients being told they can’t see the NIH research plan because the plan might change. What? All plans change. That’s the nature of plans. It’s not an excuse for withholding the plans from those most affected.

Or HHS’ decision to reclassify CFS in the ICD-10-CM to be a subtype of the symptom of chronic fatigue despite recommendations from the CFSAC, the IACFS/ME and patient organizations and advocates against it. Despite the fact that the change is against standards set by the World Health Organization, which classifies CFS as neurological.

This CFSAC meeting? Let’s be real. This change isn’t about cost savings. It’s about stakeholder avoidance.

And on and on and on. Blow off responses. Minimal information. No transparency. One-way communication. Utter disregard for this community. We are often told “Nothing about me without me.” But HHS’ real modus operandi is “Everything about ME without ME.”

Patients are very angry. For thirty years, HHS has willfully refused to make a serious, urgent commitment to the specific disease that patients have – in fact has utterly obscured the existence of the disease described by the Canadian Consensus Criteria to the point that doctors do not even think its real. HHS has willfully refused to engage the very people most affected by its actions. And HHS has made it clear it has no intention of changing.

It is insanity for us to continue to have faith in HHS’ actions.

 

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Gabby Klein, CFSAC Testimony, December 2013

Posted on December 10, 2013 by Jennie Spotila

Gabby Klein was waitlisted for a public comment slot on both days of the 2013 CFS Advisory Committee meeting. I’m happy to publish her comments in their entirety.

My name is Gabby Klein.  I became very ill in February 2003 with what was ultimately diagnosed as Myalgic Encephalomyelitis known as Chronic fatigue Syndrome in the U.S.  Since that time I have been disabled from work and am reliant on others for my care.

Throughout my eleven year illness, I have suffered a lot but, lately what I have been feeling is anger.  This anger has been fueled by the organized effort of HHS to marginalize this disease and dismiss its patients.

The following quote by Hubert H. Humphrey is highlighted on the HHS website:

‘It was once said that the moral test of government is how that government treats those who are in the dawn of life, the children; those who are in the twilight of life, the elderly; and those who are in the shadow of life, the sick, the needy and the handicapped.’

As a person ‘in the shadow of life’ I do not feel that HHS has my best interest in mind. Moreover, current actions by HHS have had a great impact in my diminished confidence and my lack of trust in the HHS and its agencies.

The NIH has repeatedly denied the appropriate funding for research into the disease and the CDC has given it the pitiful name ‘Chronic Fatigue Syndrome’.  These actions have hampered the outcome of serious research in the disease.  To date, the CDC has defiantly refused to remove their dangerous toolkit on their website. Most importantly, the CDC still refuses to include the two day exercise testing, in their current multi-site study, as advocated by the medical community.

It is this perpetuation of ignorance of the real disease and the dissemination of harmful information that has had patients, advocates, clinicians and researchers in the field in an uproar at the latest activity by the HHS to contract with the IOM to re-define ME/CFS.  This has been done in the most devious and deceitful way, starting in August when a sole solicitation announcement suddenly appeared on a website…until the recent anonymous Q&A sent out from CFSAC’s listserv which left more questions than answers.

Many really troubling questions remain, such as:

Why did HHS lie on September 4th with their announcement that they were cancelling the sole solicitation when really they were forging ahead full force?

HHS stated that this contract with IOM was with support of CFSAC members.  If this was true, why not bring it up at the last CFSAC meeting and take it to a vote?

HHS stated that they do not generally make formal endorsements of clinical recommendations made by nongovernmental groups, as an excuse of why they will not adopt the CCC. Does this mean that HHS will not endorse the IOM definition because the IOM is a non-governmental group?

Is it a coincidence that CFS and Gulf War Illness are the only diseases tasked by the IOM, in its history, to generate a re-definition for?  Is this a concerted organized action by the government to distort, minimize and psyhologize these two diseases into oblivion?

There is not enough time for me to mention all the inconsistencies and holes in this nefarious action by HHS.  This follows of course the most disturbing non-response by HHS to the very real allegations by some of the voting CFSAC members that they were threatened by the DFO, Dr. Nancy Lee, at the last CFSAC meeting.  Is this another misdeed that will be swept under the rug? How can we be assured that these hard working voting CFSAC members can speak and act freely without feeling like they are being gagged?

I strongly suggest that today, CFSAC members make two absolutely crucial recommendations:

 

1) That 2 day CPET exercise testing be required in the CDC’s multi-site study and

 

2) That you fully and strongly endorse the letter of the 50 ME experts demanding HHS cancel the contract with IoM to redefine ME and that HHS immediately adopt the ME/CFS Canadian Consensus Criteria.

Thank you.

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My Request to Dr. Lee

Posted on December 10, 2013 by Jennie Spotila

Dr. Lee,

I know the government is closed today, and you may not be working. But I must appeal to you regarding the OWH decision to condense the two half-day CFSAC meetings into a single half-day. The list of mistakes, incompetence, and blatant misstatements related to the planning of this meeting was already long, too long for me to list here. But this latest decision disenfranchises all the patients scheduled to speak today, and will undoubtedly materially impair the Committee’s ability to discuss and consider the issues on the agenda.

OWH has an opportunity here to make a decision that will be welcomed by the advocacy community. OWH has a chance to do the right thing, and demonstrate respect for both ME/CFS patients and the gravity of the Committee’s work. Or OWH can barrel ahead with this ridiculous farce of a half-day session, and reap the criticism that will undoubtedly follow.

Please postpone this meeting. Take the time to properly plan the meeting, with all the appropriate public notice and comment requirements, and hold it in January.

Sincerely,
Jennifer Spotila

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CFSAC Last Minute Change

Posted on December 9, 2013 by Jennie Spotila

UPDATE 10:00am from Dr. Nancy Lee:

 

Because of a snow storm in the Washington DC area, the Federal Office of Personnel Management has closed all federal govt. offices in DC.  This includes the tech support we need for webinars.

Unfortunately, we cannot have the webinar today.  Additionally, we cannot get the CFSAC website updated today.

We will have the webinar tomorrow (Wed. Dec. 11) beginning at noon ET, IF govt. offices are open.   Dr Gailen Marshall, the CFSAC Chair, will work with the committee members at the beginning of the webinar to modify the agenda to accommodate the compressed timeframe.

We will have public comment tomorrow for those who were scheduled to speak on Wed.  Unfortunately, we won’t be able to accommodate the public comments that were scheduled for Tuesday because we cannot confirm with the speakers that they are available for the Wednesday time slot.

So that we have more time for the Committee to deliberate and discuss, we ask those providing public comment tomorrow to limit their speaking time to 3 minutes.

If we must cancel the webinar tomorrow (DC doesn’t handle snowy, icy roads well), we will reschedule the CFSAC meeting webinar to occur after the first of the year.

More info on government closure in DC at www.OPM.gov

 

 

DUE TO FEDERAL GOVERNMENT CLOSURE, THE WEBINAR WILL NOT HAPPEN TODAY, DECEMBER 10TH. THEY HOPE TO HAVE THE DECEMBER 11TH MEETING AS SCHEDULED.

I’ll share more information as soon as I have it.

 

 

The CFS Advisory Committee will meet via webinar on December 10th and 11th, from 12 to 5pm. In a very last minute change, CFSAC has announced that the webinar will be accessible to the general public even if you did not register.

Access the full instructions on the CFSAC website.

To connect to the meeting:

Webinar Access:
Adobe Connect URL: http://hhs.adobeconnect.com/owhcfsac/

Access to the Audio Portion of the Webinar:
Conference Call Number: 877-918-6627 | Passcode: 4429527

If you have never used Adobe Connect for a webinar before, it’s worth taking a few minutes to test your connection. Detailed instructions are available.

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IOM Panelists: The Knowns

Posted on December 7, 2013 by Jennie Spotila

In this post, we present profiles of the eight members of the Institute of Medicine ME/CFS definition panel who are known to the ME/CFS community in some capacity. Many, but not all, of them are ME/CFS experts in that they work predominantly in that area. You can read about the team who put these profiles together and the methods we used in this previous post.

Important disclaimer: Many of us know one or more of these panelists quite well. They are our doctors, our colleagues, our friends. We strove to be as objective as possible, and applied all the same research methods and questions here as we did for the other panelists.

Lucinda Bateman

Dr. Lucinda Bateman has specialized in the treatment of ME/CFS and fibromyalgia since 2000. She was educated at Brigham Young University (BA, MS) and Johns Hopkins University (MD). She practiced general internal medicine from 1991 through 2000, and then opened her Fatigue Consultation Clinic. Dr. Bateman’s sister suffered from the disease, and died from non-Hodgkins lymphoma in 2001.

Dr. Bateman has participated in research in a variety of ways. She provided patients for laboratory studies investigating XMRV and cytokine expression after an exercise challenge (the remarkable Light studies). Given her position as a solo practitioner with no university appointment, she has also participated in clinical trials for treatments including Ampligen, Cymbalta, and the Synergy trial. Dr. Bateman has also received substantial payments for speaking and research from pharmaceutical companies, including Eli Lily, Pfizer, and Forest.

Given her significant contributions to ME/CFS policy issues, it is not surprising that Dr. Bateman was nominated to the IOM panel by at least six sources. She served on the CFS Advisory Committee (2005-2010), the Board of Directors and Scientific Advisory Board of the CFIDS Association, and the board of the IACFS/ME. She also co-founded and serves on the board of OFFER (Organization for Fatigue and Fibromyalgia Education and Research).

Dr. Bateman is a co-author on the ME-ICC definition, and withdrew her signature from the expert letter in support of the CCC. Her clinic is part of the CDC multisite study, and Dr. Bateman has participated in multiple physician education efforts, including some of the CDC’s Medscape courses. Dr. Bateman brings a great deal to the IOM panel: her experience caring for more than 1,000 ME/CFS and fibromyalgia patients; her research and clinical trial experience; her physician education experience; her general internal medicine experience; and her long dedication to participating in ME/CFS policy issues.

Lily Chu

Dr. Lily Chu holds degrees from the University of Washington (BS, MD) and University of California, Los Angeles (MSHS) and is board certified in both internal medicine and geriatric medicine. Dr. Chu is also a patient with ME/CFS and is very knowledgeable about issues including definition, diagnosis, treatment, and disability.

Prior to her illness, Dr. Chu was a geriatrician at The Permanente Medical Group in San Francisco. She worked as part of multidisciplinary teams in her clinical practice and in her research into pain assessment in the elderly, quality of care and quality improvement. She has collaborated on articles that provided retrospective analysis, cross-sectional descriptive studies, and method reviews with a focus to improving the methods used. This experience will be of benefit as the IOM panel undertakes a systematic review to develop clinical diagnostic criteria for ME/CFS.

Dr. Chu has consulted with non-profit, academic, research and government groups on matters related to ME/CFS. She is a board member for the IACFS/ME and the Stanford Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Initiative. Her work with the Stanford initiative involves identifying and participating in activities that benefit patients, researchers and healthcare providers by expanding their knowledge base to improve care. Dr. Chu spoke on two panels at the April 2013 FDA Drug Development Workshop, and collaborated with Dr. Leonard Jason to conduct a patient survey prior to the meeting. The results of the survey were submitted to the FDA and were incorporated into the FDA report. Dr. Chu has participated in the CFS Advisory Committee’s review of the CDC website on CFS, and she was nominated to the Committee this year.

Dr. Chu was nominated to the IOM panel by at least two sources, and we found no conflicts of interest or payments from pharmaceutical companies. Dr. Chu joined in the experts’ letter advocating the adoption of the CCC. She brings the perspective of both the patient and the clinician-scientist to the panel, a combined skill set that is extremely relevant to the panel’s work.

Ronald Davis

Dr. Ronald Davis is Director of the Stanford Genome Technology Center. He has spent his career co-inventing techniques that have become the cornerstones of gene technology: the mapping of coding RNA which led to the discovery of RNA splicing; the use of restriction endonucleases for joining DNA fragments; the development of the first DNA microarray for gene expression profiling; and the method for constructing genetic linkage maps which made the Human Genome Project possible.

Dr. Davis has an incredible legacy of publications and patents. He has won numerous awards, including the very prestigious Gruber Genetics award in 2011. He was elected to the National Academy of Sciences (a sister institution to the IOM) in 1983, but has not served on any IOM committees. Based on his academic career alone, he would be a prestigious member of the panel and could address the many questions about ME/CFS and genomics.

But Dr. Davis has another qualification that has introduced him to many in the ME/CFS community: his son Whitney is very ill with ME/CFS. Dr. Davis has turned his formidable mind and experience to unraveling the genetics of ME/CFS. Through his own CFS Research Center at Stanford and his partnership with the Open Medicine Institute, Dr. Davis will sequence the entire genome of study participants and search for microbial causes of the disease (although a great deal has not been disclosed about the study design). Dr. Davis is on the board of the Open Medicine Institute but not the Open Medicine Foundation, a non-profit. OMI is a California B-corp and, among other things, is one of the participating locations in CDC’s multisite study.  Dr. Davis was interviewed by Ryan Prior for The Blue Ribbon documentary, and Ryan told me that one of Dr. Davis’s comments (at approximately :21) inspired one of the slogans for the film.

Many of us had never heard of Dr. Davis prior to the IOM panel announcement, and I originally listed him as a non-expert. He was nominated by at least one ME/CFS source, and our team was excited by what we learned about him. It is quite clear that Dr. Davis brings his family experience and formidable scientific mind to the panel’s task. However, it is important to note that like many other panelists, he has no clinical experience working with ME/CFS patients and no experience in creating clinical case definitions.

Betsy Keller

Dr. Betsy Keller may not predominantly work on ME/CFS, but she has certainly become a growing contributor to the field. She received a Master’s and PhD in exercise science from the University of Massachusetts. Overall, her research has focused on childhood obesity and the effect of exercise on maximizing function through all phases of life. In the last ten years, however, Dr. Keller has followed the path of Dr. Christopher Snell and Staci Stevens investigating the role of exercise capacity in ME/CFS.

Her first ME/CFS patient exercise test was performed on an Ithaca woman who could not travel to Stevens’ lab. Dr. Keller described the same reaction to the results as Stevens experienced: there must be something wrong with the equipment. She presented research at the 2011 IACFS/ME conference, and collaborated with Dr. Maureen Hanson to provide an exercise component to Hanson’s XMRV work. Dr. Keller reportedly has additional ME/CFS studies and publications underway, and provides two-day cardiopulmonary exercise testing to ME/CFS patients.

Dr. Keller was recently nominated to the CFS Advisory Committee by Dr. Hanson, and signed on to the expert letter advocating for the immediate adoption of the CCC. Beyond that, she has not taken a public position on the ME/CFS case definition, nor does she have expertise in developing such definitions. While Dr. Christopher Snell and Staci Stevens received more nominations to the IOM panel, Dr. Keller can bring a similar expertise with two-day CPET and interpreting those unusual results in ME/CFS patients.

Nancy Klimas

Dr. Nancy Klimas has earned the title “ME/CFS expert” through almost twenty years of work on this disease. She studied ME/CFS and ran a clinical practice at the University of Miami for many years. In 2012, Dr. Klimas opened the Institute for Neuroimmune Medicine at Nova Southeastern Unversity, where she also chairs the Department of Clinical Immunology.

She has consistently been among the most successful ME/CFS researchers in securing funding from NIH and the Department of Defense, including a $4 million grant announced last month. Dr. Klimas was one of the pioneers of ME/CFS crossover research, incorporating CFS patients into Gulf War studies. Her collaborations with Dr. Mary Ann Fletcher, Dr. Gordon Broderick, and others, have led to some of the most extensive work characterizing immune system abnormalities and systems networking in this field. Dr. Klimas has combined her clinical practice and research, applying information learned at bedside or bench to the other. She is participating in the CDC multisite study, and has conducted clinical trials on Ampligen.

Dr. Klimas has contributed to ME/CFS issues in numerous ways. She is past president of the IACFS/ME, served on the CFS Advisory Committee from 2007-2012, and also served on the CFIDS Association Scientific Advisory Board. She is a Principal Investigator with the Chronic Fatigue Initiative, and has spoken at hundreds of meetings including the April FDA Workshop and last month’s Mt. Sinai ME/CFS conference. Dr. Klimas has been interviewed for the Canary in the Coalmine documentary, and is perhaps most quoted for telling the New York Times that given the standard of care in 2009, she would rather have AIDS than ME/CFS.

Out of all the panelists, Dr. Klimas has probably made the most public statements on the ME/CFS case definition. She is a co-author of both the CCC and ME-ICC definitions. She signed the expert letter urging HHS to adopt the CCC. Dr. Klimas was nominated to the IOM panel by at least six sources, so it’s clear that she is widely regarded as a vocal and highly qualified expert on the subject.

 

Martin Lerner

Dr. A. Martin Lerner is an infectious disease specialist with an MD from Washington University School of Medicine. He served as Chief of the Division of Infectious Diseases and Professor of Internal Medicine at Wayne State University School of Medicine, 1963-1982. Dr. Lerner now treats CFS and tick-borne diseases at his Treatment Center for Chronic Fatigue Syndrome, and is a Professor in the Department of Internal Medicine at Oakland University William Beaumont School of Medicine.

Dr. Lerner believes that ME/CFS is caused by persistent herpes virus infection, including Epstein-Barr virus, Cytomegalovirus and HHV-6, singly or in combination. In both his research and clinical practice, Dr. Lerner has focused on identifying and treating these persistent infections. As part of diagnosing ME/CFS, Dr. Lerner uses 24-hour Holter ECG monitoring. He believes that abnormal results are a biomarker for CFS, and that absence of abnormal results indicates fatigue is not caused by CFS. In 2010, Dr. Lerner published the results of a retrospective review of his clinic data showing that 74% of selected patients dramatically improved after treatment with valacyclovir or valganciclovir. He presented these results at the CFS Advisory Committee Science Day on October 12, 2010.

Dr. Lerner is the only infectious disease specialist on the panel, a critical role, and reportedly is recovered from ME/CFS himself. We found no evidence of conflict of interest. Dr. Lerner is a co-author on the CCC, and signed the experts’ letter in support of adopting that definition. His strong views on the causation and diagnosis of ME/CFS are relevant to the IOM panel’s task.

 

Benjamin Natelson

Dr. Benjamin Natelson is a neurologist with a long history of both patient care and ME/CFS research. He was a Professor of Neurology and Neurosciences at the University of Medicine and Dentistry of New Jersey, now part of Rutgers University. While at UMDNJ, Dr. Natelson led one of the NIH’s CFS Cooperative Research Centers before all the centers were closed in 2002. Now Dr. Natelson provides an integrated approach to patient care and research at the Beth Israel Medical Center and Albert Einstein College of Medicine.

Dr. Natelson’s research on ME/CFS has examined the role of the central nervous system in ME/CFS and other diseases. He has researched fibromyalgia, Lyme Disease, Gulf War Illness and ME/CFS patients. Among his notable studies is the finding of unique proteome markers in the cereberospinal fluid of ME/CFS patients and evidence that CFS and fibromyalgia are different illnesses. Dr. Natelson has collaborated extensively with Dr. Dane Cook, incorporating submaximal exercise challenge into much of his work. Dr. Natelson has generally been one of the more successful researchers in obtaining NIH funding, including a $2 million grant earlier this year shared with collaborators at Weill Cornell Medical College.

Dr. Natelson’s clinical practice is widely recognized, and does incorporate very gentle physical conditioning along with other treatments. He’s written two books for patients and spoken at numerous venues, including the Massachussetts CFIDS/ME & FM Association in 2012 and the NIH State of the Knowledge meeting in 2011. His clinic is a participant site in the CDC multisite study.

Dr. Natelson was nominated to the IOM panel by at least four ME/CFS sources. He did not sign the expert letter regarding the CCC (although his wife, Dr. Gudrun Lange, did). In 1994, Dr. Natelson was part of the International CFS Study Group that contributed to the Fukuda definition. Since that time, Dr. Natelson has become a “splitter,” believing that subtypes can be identified through biomarkers and symptom constellations. His focus on the involvement of brain disease and encephalopathy in ME/CFS is highly relevant to the IOM panel.

Peter Rowe

Dr. Peter Rowe is Professor of Pediatrics at Johns Hopkins University School of Medicine, and Director of the Chronic Fatigue Clinic at Johns Hopkins Children’s Center. After receiving degrees at Trinity College (BA) and McMaster University Medical School (MD), Dr. Rowe has spent most of his professional career at Johns Hopkins. Dr. Rowe started the Chronic Fatigue Clinic in 1997, and it has grown into the largest and most respected pediatric ME/CFS practice in the country.

Dr. Rowe is a clinician-researcher, like many other ME/CFS experts, and he pioneered investigation into the orthostatic intolerance issues that frequently accompany the disease. In 1995, Dr. Rowe and his collaborators published two seminal papers on the issue. The first reported evidence of neurally mediated hypotension in seven adolescents, and the second reported the same results in 23 adults. Treatment with Florinef and/or beta blockers showed promise for treatment in both groups. In 2001, Rowe and colleagues reported the results of a placebo-control trial of Florinef in adults that did not show a statistically significant difference between the groups. However, both Dr. Rowe and many ME/CFS patients have continued to use treatment for neurally mediated hypotension and report positive results. As a result of Dr. Rowe’s work, testing and treatment for orthostatic intolerance is considered standard of care among ME/CFS experts. Dr. Rowe has pursued other hypotheses in ME/CFS research, including the connection to Ehlers-Danlos and neuromuscular strain, and has received support from NIH and non-profit sources. Dr. Rowe has presented on these topics many times, including via webinar, the NIH State of the Knowledge Workshop in 2011, and the April 2013 FDA Drug Development Workshop.

In addition to clinical and research efforts, Dr. Rowe has participated in numerous ME/CFS policy efforts. He has served on advisory boards for the CFIDS Association several times (1999-2002, 2013- present), as well as NIH grant review committees, and the NIH Chronic Fatigue Syndrome Coordinating Committee of the NIH (1999-2002). Also of note is his role as a peer reviewer on the systematic evidence review authored by Dr. Cynthia Mulrow (discussed in a previous post). Dr. Rowe has participated in some of the CDC physician education efforts, and given presentations to the CFS Advisory Committee. We found no evidence of pharmaceutical payments or other conflicts of interest.

Dr. Rowe was nominated to the IOM panel by at least seven ME/CFS sources, more than anyone else that we could confirm. He did not sign the experts’ letter and is not a co-author on any ME/CFS disease definition paper. His clinical expertise focused on pediatric ME/CFS will be an important asset to the panel, as is his knowledge of orthostatic intolerance issues associated with the disease.

Acknowledgements: This post was a group effort, and would not have been possible without the assistance and participation of Lori Chapo-Kroger, Claudia Goodell, Chris Heppner, Denise Lopez-Majano, Mike Munoz, Darlene Prestwich, Tamara Staples, WillowJ, and one advocate who wished to remain anonymous.

 

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IOM Panelists: The Unknowns

Posted on December 5, 2013 by Jennie Spotila

In this post, we present profiles of the seven members of the Institute of Medicine ME/CFS definition panel who were unknown to the ME/CFS community. You can read about the team who put this together and the methods we used in this previous post.  In assessing conflict of interest in these profiles, we defined conflicts very narrowly. We looked for direct financial interests that could influence panel members in defining ME/CFS. For example, payments from disability insurance companies would be highly relevant and potential conflicts. The conflicts assessments presented in this post are limited to those direct interests. In a future post, we will share a summary of our discussion about whether to define conflicts more broadly and consider other types of financial issues.

 

Ellen Wright Clayton, Chair

Simply put, Dr. Ellen Clayton is a heavy hitter. She holds joint faculty appointments to the Vanderbilt University School of Law and Medical School. She received degrees from Duke University (BS), Stanford University (MS), Yale University (JD), and Harvard University (MD). For more than thirty years, she has focused on the crossroads of law, ethics and medicine in genetic testing. Dr. Clayton has established expertise in newborn and pediatric genetic screening issues, and co-founded Vanderbilt’s Center for Biomedical Ethics and Society. She directed that Center for twelve years, and has served on more than forty Vanderbilt University committees since her arrival there in 1988. More recently, Dr. Clayton has focused on genetic biobanks and big data projects, including the International HapMap Project and the Human Genome Organization. While some of these issues are relevant to ME/CFS research, particularly given the growing number of biobanks and big data, Dr. Clayton has no discernible subject matter expertise in ME/CFS or in creating case definitions.

However, Dr. Clayton has a remarkable amount of Institute of Medicine experience. She was elected to the IOM in 2006, but her IOM service dates back to 2002 when she began a five-year term on the Board on Health Sciences Policy. She has served on a total of ten committees since 2003, and chaired four of them. Specifically, Dr. Clayton chaired the Committee to Evaluate the HHS Program on Family Planning in 2009, and now chairs the Standing Committee on Family Planning. Dr. Clayton co-chaired the Committee on Commercial Sexual Exploitation and Sex Trafficking of Minors in the United States which just issued its report in September 2013. Her combination of legal and pediatric experience was particularly relevant here. Finally, Dr. Clayton chaired the Committee to Evaluate Vaccine Safety, which delivered its report in 2011. The Committee investigated the evidence for a number of adverse events connected to vaccines, including autism and chronic fatigue syndrome. While there was causal evidence for many adverse events, no connection was found with autism or CFS. Two other members of that committee are of interest: Dr. Anthony Komaroff, a well-known and highly regarded ME/CFS expert, and Dr. Betty Diamond, who has also been appointed to the IOM ME/CFS panel and who is profiled below.

In addition, Dr. Clayton has been a member of the IOM Advisory Council since 2010, and in 2012 she was appointed to a three-tear term as Chair of the Board on Population Health and Public Health Practice. In October this year, Dr. Clayton received the David Rall Medal for exemplary service to the IOM. The medal is awarded to a member of the IOM that has demonstrated “a commitment substantially above and beyond the usual expectations of a committee chair.”

Bottom line? Dr. Clayton knows IOM. She has already chaired four committees, including one investigating the controversial topic of vaccine safety. She has a distinguished academic career, demonstrable leadership capacity, and significant influence at the IOM itself. We found no evidence of financial conflict of interest or bias on ME/CFS. However, it should be noted that Dr. Clayton has no experience in creating case definitions, and little public knowledge of ME/CFS. She may have been selected as chairman for her IOM process experience, her ability to tackle big issues, and (perhaps) because this panel has already been so controversial.

Margarita Alegria

Dr. Margarita Alegria is a psychologist with a focus on mental health population research. She holds degrees from Georgetown University (BA), the University of Puerto Rico (MA), and Temple University (PhD). Her academic career has been spent at the University of Puerto Rico and at Harvard University, where Dr. Alegria has been Director of the Center for Multicultural Mental Health Research (CMMHR) since 2002. She has served as a consultant to multiple academic institutions and an expert presenter for Shire US, Inc., a pharmaceutical company. According to her CV, Dr. Alegria served on the Steering Committee for the DSM-V Developmental Workgroup in 2001, and has been a grant reviewer for NIH. Her work has been funded by NIH and most recently by PCORI. Dr. Alegria’s research has focused on mental health disparities and care delivery in multicultural populations, and this is also the mission of multiple research projects at the CMMHR.

Dr. Alegria was elected to the Institute of Medicine in 2011. She currently serves on the Board on Population Health and Public Health Practice (chaired by Dr. Ellen Clayton, profiled above).  Dr. Alegria served on the Committee on Standardized Collection of Race-Ethnicity Data for Healthcare Quality Improvement, which issued its report in August 2009. She also served on the Committee on The Mental Health Workforce for Geriatric Populations that delivered its report in July 2012. Finally, Dr. Alegria is a member of the Committee on Initial Assessment of Readjustment Needs of Military Personnel, Veterans, and Their Families which issued two reports in March 2010 and March 2013. While these reports do discuss fatigue and related syndromes like Gulf War Illness, they do not discuss ME/CFS in a substantive way.

The HHS announcement of the IOM contract stated that the committee would include expertise in behavioral health, and Dr. Alegria fits that category. We think it is safe to assume that ME/CFS advocates would prefer for psychologists/psychiatrists to be kept far away from this panel, although that was never likely given the large body of research in this area. Dr. Alegria has not done any research on ME/CFS, but she does have several publications that may give some advocates pause. Two papers examine the connection between physical symptoms and mental health services delivery. In 2010, Dr. Alegria co-authored a paper that concluded, “physical symptoms are an important component of common mental disorders such as depression and anxiety and predict service use in community populations.” A followup paper in 2012 found that the presence of physical symptoms was not a barrier to mental health service use by some minority populations. Finally, Dr. Alegria co-authored a paper finding comorbidity between neurasthenia and psychiatric disorders. The term neurasthenia has been controversially applied to ME/CFS, as recently as this year.

Despite these publications that relate to psychology and somatic symptoms, they represent a tiny fraction of Dr. Alegria’s body of work. We found no evidence that she believes ME/CFS is psychogenic in origin, or that she supports CBT as a treatment for the disease. In addition, we found no conflicts of interest or negative bias.

Charles Cleeland

Dr. Charles Cleeland is a psychologist by training, but has focused his work on pain and cancer studies. He is Chair of the Department of Symptom Research, Division of Internal Medicine, University of Texas MD Anderson Cancer Center and is also director of the Pain Research Group at that institution. Dr. Cleeland has authored more than 350 publications, many of which are focused on pain. He is a past president of the American Pain Society, and member of the International Association for the Study of Pain. This research is potentially relevant given the prominence of chronic pain for many ME/CFS patients. In addition, Dr. Cleeland is familiar with animal models of sickness behavior (such as Dr. Glaser’s work) and “hypothesizes that inflammation and its downstream toxic effects represent a significant biological basis for subjectively reported clusters of symptoms, cognitive impairment, and neuropathies.”

A closer look at Dr. Cleeland’s work also shows him to be interested in quality of life measures, outcome measures, symptom burden, cognitive impairment (usually as a result of cancer treatment), and cancer-related fatigue (CRF). Dr. Cleeland has helped develop three symptom inventory scales:  The Brief Pain Guide, a widely used self-assessment scale of pain and function (used by Dr. Fred Friedberg in a CFS study); the MD Anderson Symptom Inventory (MDASI), a multi-symptom patient-reported outcome (PRO) measure focused on core symptoms that have the highest frequency and/or severity in patients with various cancers and treatment types; and the Brief Fatigue Guide, an assessment of cancer-related fatigue and quality of life. Each of these scales are validated self-assessment measures of symptom severity, function, and symptom impact, at least in cancer if not other conditions.

In 2011, Dr. Cleeland edited Cancer Symptom Science: Measurement, Mechanisms, and Management, for which he was also co-author of the Introduction and three chapters. Keeping in mind that he was the editor of the book and not the sole author, it is interesting to note that chronic fatigue syndrome is mentioned in several places in the book. CFS is characterized as a physiological illness (with a viral connection implied), and in more than one place the book mentions that studying the brain mechanisms of CFS could “help us form hypotheses relevant to the cortical processing of cancer-related fatigue.”

Dr. Cleeland co-chairs an independent and multidisciplinary work group: Assessing Symptoms of Cancer Using Patient-Reported Outcomes, that is developing recommendations for symptom measurement in oncology clinical trials, with financial support from pharmaceutical companies. ASCUPRO has noted that the fatigue in CFS, multiple sclerosis, cancer and other diseases is pathological, may differ between disease states and may possibly require different fatigue measures. Dr. Cleeland has chaired NIH and NCI advisory groups in the area of pain and symptom research. He has also participated in clinical trials to improve cancer pain management, including in under served populations. Dr. Cleeland receives substantial NIH support for his work. He is neither a member of the IOM, nor has he served on any IOM committees.

We have not found evidence of conflict of interest or negative bias. We also did not find direct evidence that Dr. Cleeland is familiar with ME/CFS definition issues. However, as we have noted, Dr. Cleeland does seem to recognize that CFS (at least) is physiological, and is concerned about symptom burden and cognitive function. Dr. Cleeland’s expertise in the creation and application of patient-reported outcome measures is highly relevant to ME/CFS, as evidenced at the April FDA Drug Development Workshop. Understanding epidemiological data and measurement questions will also likely be part of the ME/CFS case definition effort. These factors and his expertise with pain both suggest Dr. Cleeland could play a positive and significant role in the ME/CFS case definition study.

Betty Diamond

Dr. Betty Diamond is a rheumatologist educated at Harvard University (BA, MD). She is chief of the Autoimmune Disease Center at North Shore-LIJ Health System, and head of the Center for Autoimmune and Musculoskeletal Diseases at The Feinstein Institute for Medical Research. The Feinstein Institute is an enormous research institution focused on disease-oriented research, and receiving $45 million per year from NIH.

Dr. Diamond’s laboratory studies the role of B cells in the systemic lupus, an autoimmune disease. Her team has also investigated whether autoantibodies might cause brain injury if they penetrate the blood-brain barrier. These antibodies may contribute to acquired changes in cognition or behavior in people with and without autoimmune disease, as well as autism or PTSD. Her discoveries have led to the development of possible treatments for lupus, and Merck funds lupus treatment research at Feinstein. She has conducted clinical trials in lupus and rheumatoid arthritis, and has published extensively in these fields.

When she joined the Feinstein Institute in 2007, Dr. Diamond was the third-largest recipient of NIH funds in the New York metropolitan area.  She is a past president of the American Association of Immunologists and in 2008 received the Lupus Foundation of America’s Evelyn V. Hess Research Award for lifetime achievement in lupus research. She has also won an NIH MERIT award, which is intended to “provide long-term grant support to investigators whose research competence and productivity are distinctly superior and who are highly likely to continue to perform in an outstanding manner.” Investigators do not apply for MERIT awards; they are selected by NIH Institute Councils for their excellence in research. Beyond bench and clinical trial research, Dr. Diamond’s group provides consultation services to lupus patients, and she has spoken about the racial and economic disparities that impact lupus and autoimmune disease research. Dr. Diamond was elected to the IOM in 2006, but has only served on one Committee, the Review of Adverse Events in Vaccines which was chaired by ME/CFS panel chair Dr. Ellen Wright Clayton (profiled above).

Not surprisingly, given her clinical trial research, Dr. Diamond has multiple connections to pharmaceutical companies. She received approximately $19,000 in 2010-2012 for consulting services to Pfizer, Merck, and EMD Serono. She previously served on the scientific advisory board of Anthera Pharmaceuticals and is a scientific advisor to Sequenta, Inc., a biotech company focused on clinical diagnostics based on immune system status.

Dr. Diamond’s experience as a rheumatologist and in autoimmune disease research is highly relevant to ME/CFS, especially given the research advances published in the last several years. She is passionate about her work and helping people with lupus, and has had a successful and distinguished career in her field of study. We found no indication that Dr. Diamond is familiar with ME/CFS definition issues, nor did we find any evidence that she has preconceived ideas about the disease that could create negative bias.

Theodore Ganiats

Dr. Theodore Ganiats is a Professor of Family and Preventive Medicine at the University of California San Diego (UCSD) School of Medicine, where he received his own medical degree. His research focuses on outcomes measures, quality of life assessments, and how outcomes research is translated into the clinical setting. He also maintains a clinical practice specializing in family medicine and primary care at the UCSD Health System and was Chief of the Division of Family Medicine from 1986 to 1997.

Dr. Ganiats is the Executive Director of the UCSD Health Services Research Center, a non-profit research organization focused on understanding how clinical and treatment services affect health outcomes.  Projects have included mental health prevention, mental health services, PTSD outcomes for veterans receiving cognitive processing therapy, as well as a variety of studies such as TB diagnostics and diabetes prevention programs. He has well over 100 publications, focused mainly on outcomes research. We found only one payment for consulting and travel from Pfizer in 2010.

Dr. Ganiats was elected to the IOM in 2006, and served on the Committee on Oral Health Access to Services, which delivered its report in 2011. Last month, he was nominated by the American Academy of Family Physicians to a vacancy on the Board of Governors for PCORI. Dr. Ganiats has represented the AAFP on a number of clinical guidelines committees, which seems like a natural fit with the IOM ME/CFS study. However, his ties to the AAFP may give some advocates pause, given some of their publications on ME/CFS. (I analyzed some of that material last year.)

We did not find any evidence that Dr. Ganiats has a bias about ME/CFS. However, one of his close colleagues appears to have one. Dr. William J. Sieber is the Research Director for the division of Family Medicine, and has co-authored papers with Dr. Ganiats. Dr. Sieber is also a part of Inner Solutions for Success, which provides consultation and coaching services to healthcare professionals. Dr. Sieber’s bio page includes a slide deck titled “Calming the Anxious Brain.” Some of the material on CFS in that presentation is accurate, but it also includes statements like this: “Metabolism of CFS patients is normal so symptoms are due to psychological factors, with mental fatigue considered a lack of motivation (brain is major consumer of resting cellular energy!)” (p. 21)

Dr. Ganiats brings expertise in family medicine (a stated interest of the IOM study) and outcomes measures (an important part of operationalizing a case definition). He also has broad experience in creating clinical practice guidelines and measuring how outcomes research translates to the clinical setting. All of this is highly relevant to the IOM ME/CFS study. We do not know what, if anything, Dr. Ganiats knows or thinks about the disease, but his connections with the AAFP and Dr. Sieber at least raise the possibility that Dr. Ganiats may believe the disease is something very different from what we all understand it to be.

Cynthia Mulrow

Dr. Cynthia Mulrow is an adjunct professor of medicine at the University of Texas Health Science Center at San Antonio. Dr. Mulrow received her MD from Baylor University, but has spent most of her professional career specializing in research methodology, systematic review, and evidence based medicine. She is a senior deputy editor for the Annals of Internal Medicine, and former director of both the San Antonio Cochrane Collaboration Center (now closed) and San Antonio Evidence-Based Practice Center.

Dr. Mulrow has been on the faculty at the Health Science Center since 1987, and also served as a member of the U.S. Preventive Services Task Force from 1998 to 2002. She has authored many publications on systematic reviews, and evidence based clinical guidelines.  Her focus is the methods “that aid comprehensive collation, unbiased and explicit evaluation, and systematic summarization of available research.” It is not at all surprising that the IOM sought to include this expertise on the panel.

Dr. Mulrow was elected to the IOM in 2007, and has served on two consensus panels. The first examined Cognitive Rehabilitation Therapy for Traumatic Brain Injury and delivered its report in 2011. The second panel examined Standards for Developing Trustworthy Clinical Practice Guidelines.  Its report, also issued in 2011, recommended eight standards for developing rigorous, trustworthy clinical practice guidelines. Dr. Mulrow has also participated in several IOM workshops, including a discussion of data standards for PCORI.

All of this experience makes Dr. Mulrow very qualified to tackle the massive systematic evidence review that will be part of the IOM ME/CFS study. However, this will not be the first time she has worked on an evidence review for chronic fatigue syndrome. In 2001, Dr. Mulrow led the contract at the San Antonio Evidence-Based Practice Center to do a systematic review on Defining and Managing Chronic Fatigue Syndrome. Obviously, the science was different in 2001, but one of the main conclusions of the review was

Definitions, developed primarily by expert knowledge and consensus, have evolved over time. A few comparative research studies support the concept of a condition, characterized by prolonged fatigue and impaired ability to function, which is captured by the case definitions. The superiority of one case definition over another is not well established. The validity of any definition is difficult to establish because there are no clear biologic markers for CFS, and no effective treatments specific only to CFS have been identified.

It’s important to note several things about this report. First, the technical experts and peer reviewers included: Dr. Leonard Jason, Dr. Nancy Klimas, Dr. Anthony Komaroff, and Dr. Peter Rowe, as well as others not so well-regarded by the ME/CFS community such as Dr. Simon Wessely and Dr. Peter White. Second, the Agency for Healthcare and Research Quality is embarking upon another systematic review as part of NIH’s Evidence-based Methodology Workshop, which will (hopefully) update and expand the 2001 analysis.

Also in 2001, Mulrow and colleagues published Interventions for the Treatment and Management of Chronic Fatigue Syndrome in the Journal of the American Medical Association. The review followed the same approach that the current IOM study appears to be using, in that “CFS was taken to mean all illnesses, including ME and PVFS with symptom complexes similar to CFS, unless otherwise stated.” (p. 1360) The analysis found that there was no significant association between the definition used and treatment study outcome (p. 1366). However, the paper also reports many weaknesses and limitations in the treatment studies, including the failure to characterize baseline functionality in a standardized way. CBT and GET were considered promising, but “All conclusions about effectiveness should be considered together with the methodological inadequacies of the studies.” (p. 1367)

The main issue regarding Dr. Mulrow is whether she can look at the ME/CFS world of 2013 with fresh eyes. There have been scientific advances since the 2001 review, but many challenges in the data remain. We found no evidence of any statements or publications by Dr. Mulrow about ME/CFS since those 2001 papers, so we do not know if she has a dogmatic and unchanged view. It is possible that she will be an asset to the panel, both for her methodological expertise and her previous examination of the data. That will depend on whether she is able to examine the evidence and listen to the panelists without undue bias.

Michael Shelanski

Dr. Michael Shelanski is Chairman of the Department of Pathology and Cell Biology at Columbia University.  He received an MD/PhD from the University of Chicago. Dr. Shelanski’s research has focused on cell and animal model approaches to study memory disruption and synaptic dysfunction in Alzheimer’s and other neurodegenerative diseases. Dr. Shelanski is on the faculty of the Taub Institute at Columbia, an NIH-funded Alzheimer’s disease research center. His extensive publications cover cell biology, neuropathology, gene expression, and impact on disease. Dr. Shelanski has received extensive funding from NIH for his work, and has served on multiple advisory committees and boards during his career, as well as the editorial boards of many scientific journals.

Dr. Shelanski was elected to the Institute of Medicine in 1999, but has only served on a single committee: the Review of the Appropriate use of AFIP’s Tissue Repository Following its Transfer to the Joint Pathology Center committee. The committee’s report, issued in October 2012, made recommendations regarding the preservation and use of the Army’s extensive repository during its transition. The repository is significant for, among other things, preserving the tissue that made the genomic sequencing of the 1918 influenza virus possible.

We found no evidence for conflicts of interest, nor did we find any connection or bias regarding ME/CFS. However, Dr. Shelanski’s participation in the panel is a bit of a puzzle. Certainly research into neurodegenerative conditions could be relevant to ME/CFS, and Dr. Shelanski is clearly a distinguished scientist. His work has focused on cell biology and animal models, more of a “bench” than “bedside” approach. Given that the IOM panel will be creating an evidenced-based clinical case definition, we do not understand Dr. Shelanski’s qualifications to create such a definition or a plan for disseminating the definition to health professionals.

Acknowledgements: This post was a group effort, and would not have been possible without the assistance and participation of Lori Chapo-Kroger, Claudia Goodell, Chris Heppner, Denise Lopez-Majano, Mike Munoz, Darlene Prestwich, Tamara Staples, WillowJ, and one advocate who wished to remain anonymous.

 

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IOM Panelists: Method to Our Madness

Posted on December 5, 2013 by Jennie Spotila

My plan upon the announcement of the Institute of Medicine panel was to provide detailed write ups on all the members within 48 hours. Reality smacked me upside the head after about 24 hours. I am working with a wonderful team to get this done, as you will see, but many of us have had medical appointments and family situations this week, and all of us are personally affected by the severe limitations of ME/CFS in some way. The project is taking a bit longer than anticipated, but I expect that the first group of profiles on the seven “Unknowns” will be ready later today. For now, I would like to explain our methods so that you can see how we pulled all of this together.

The Team: I am lucky to be working with a great team of fellow advocates: Claudia Goodell, Chris Heppner, Lori Chapo-Kroger, Denise Lopez-Majano, Mike Munoz, Darlene Prestwich, Tamara Staples, WillowJ, and one advocate who wished to remain anonymous.  I posted requests for help several weeks ago on Facebook, this blog, and at least one ME/CFS forum. All of the team volunteered, although some may have needed encouragement. Before the announcement of the panel, we formulated research questions and collected sources to guide the work. Several of us did practice dry runs of these questions and adjusted based on what we learned. I assembled a list of nominees from as many sources as possible, and that helped, but half of the panel were completely new names to us. The team was on standby for the panel announcement, and we got to work within 30 minutes of the announcement. I am deeply grateful to each volunteer for their tremendous work, and this project would not have been remotely possible without all of their involvement.

The Goals: The project has evolved as we’ve researched and discussed our findings. We now have three goals, and will address them in successive posts over the next few days:

  1. To provide well-researched profiles of each of the 15 panelists to help the community assess and provide feedback to IOM.
  2. To share our own discussions about the panelists and overarching issues. While we do not represent every viewpoint in the community, we do cover a fair part of the spectrum. We will share with you the questions and conclusions that we have discussed.
  3. To propose a response to IOM. We may not be able to reach consensus within our team, we’ll do our best to share a cohesive response with you. We will also provide more information about how you can submit feedback to IOM as well.

The Methods: To prepare the well-researched profiles, we have examined numerous sources. We focused on characterizing the individual’s career, involvement with the IOM, and their relevant expertise. We screened curriculum vitae, publication history, and nonprofit work. We looked for conflicts of interest and bias, and screened the unknowns for any position or familiarity with ME/CFS or overlapping conditions. We watched videos of their talks and examined their funding history. We’ve discussed what we found about the unknowns as a group, raising more questions. Finally, I collaborated with team members to draft and refine the profiles. Now you know why I am so grateful to the team for their extensive work!

What Next: The first batch of profiles will go up later today. Our goal is to post all the profiles by the end of the day tomorrow, and then move on to our assessments of the panel. Stay tuned!!

 

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IOM Panel Announced

Posted on December 3, 2013 by Jennie Spotila

The Institute of Medicine has posted the provisional panel for public review and comment. I am working with a group of advocates to research all the members, seek out bias or conflicts of interest, and bring that information to you as quickly as possible. For now, here is the list categorized by ME/CFS expert and non-expert members.

ME/CFS Experts* (7 of 15)

  • Dr. Lucinda Bateman
  • Dr. Lily Chu
  • Dr. Betsy Keller
  • Dr. Nancy Klimas
  • Dr. Martin Lerner
  • Dr. Benjamin Natelson
  • Dr. Peter Rowe

Non-Experts (8 of 15)

  • Dr. Ellen Wright Clayton
  • Dr. Margarita Allegria
  • Dr. Charles Cleeland
  • Dr. Ronald Davis
  • Dr. Betty Diamond
  • Dr. Theodore Ganiats
  • Dr. Cynthia Mulrow
  • Dr. Michael Shelanski

More to come!!!!!

*Upon further reflection, I think it’s important to note that not all of these folks are experts in the sense that they predominantly work on ME/CFS. However, all of them are known to the community in some capacity and have done ME/CFS related work.

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