The First ‘Death Contract’
Some advocates felt GWI patients were in for a big fall…
Some advocates pointed to the IOM contract to produce a definition for Gulf War Illness IOM as what not to do in ME/CFS. With no Gulf War Illness experts sitting on the panel, and with an unsatisfactory previous IOM Gulf War Illness report, fears were high that the disorder would be misnamed and mischaracterized. A psychological interpretation was considered likely.
Gulf War Illness is, after all, every bit as controversial as Chronic Fatigue Syndrome and has received less study, and had a potential albatross hanging around it’s neck; a vague CFS-like name “Chronic Multisymptom Illness” that had been used to describe GWI it for over a decade.
With no GWI experts sitting on the panel surely GWI patients were due for a major fall.
IOM Report
That didn’t happen. While the IOM GWI definition report didn’t please everyone, it didn’t fulfill their worst expectations either.
The Committee essentially felt GWI was too poorly studied (no clinically validated tests), too variable (GWI patients with markedly different symptoms), and really too difficult to understand given the time lag between exposure (over twenty years ago) and the present, given the limited research, for it to be able to produce new definitions.
The IOM panel felt they had too little data to produce a new definition
The panel stated they lacked data on several aspects of definition creation (duration, onset, severity, laboratory findings) and noted that the studies proposing new definitions lacked many of the elements needed to produce one.
They proposed that two widely used case definitions continue to be used until the data for a new definition is generated. The committee also recommended that the current name, Gulf War Illness, continue to be used to describe the illness.
James Binns slammed the report calling it a ‘slanted report’ which protrayed “a slanted view of Gulf War research totally inconsistent with the science of the past decade”. Binn’s critique appeared, at least in part, to stem from his upset with the scope of a report which was focused on creating a definition, not at determining the cause of the illness.
Gulf War Illness – A Unique Disorder
Symptomatically, GWI may appear very similar to ME/CFS, but in some ways it is very different.
ME/CFS has received much more study (Pub citations – GWS – 1764, CFS – 6200), was not triggered by an event distant in time, but is being triggered (unfortunately) all the time which makes it much easier to study, and has a much, much stronger advocacy community. (The main critic of the IOM GWI report, James Gunn, does not have a website. The first mention of the IOM GWI definition report by an ‘advocacy’ group found during a Google search was on the Phoenix Rising website. Ironically, the ME/CFS community appears to be tracking this issue more closely than the GWI community.)
In contrast to the Gulf War Panel, the IOM panel for ME/CFS has a solid core of Chronic Fatigue Syndrome experts.
In some important ways GWI and Chronic Fatigue Syndrome are very different disorders
With the IOM’s GWI panel rejecting a term (Chronic Multisymptom Illness) that’s been in use in GWS for over a decade, the possibility of a ME/CFS expert rich panel agreeing to a similar term for ME/CFS is unimaginable. The GWI’s panel conservative approach to definition-making suggests ME/CFS advocates have little to fear about the IOM’s ‘Death Contract’ turning radically sour.
The biggest question, perhaps, is whether the ME/CFS IOM panel will come up with a clinical definition at all. My guess, is that they will be able to given the several consensus definitions present, the more studies available, the presence of ME/CFS physicians on the panel, and the results of the CDC’s multi-site ME/CFS experts study. We shall see!
Suzanne Vernon of the CFIDS Association of America was a member of the IOM panel. Below is the CAA’s report on the definition. (Thanks to the CAA for allowing their original review to be published on Health Rising.)
From the CFIDS Association of America – A Tale of Two IOM Committees
Today the Institute of Medicine (IOM) published the report titled, “Chronic Multisymptom Illness in Gulf War Veterans: Case Definitions Reexamined”.
Given that the IOM has been engaged in a project regarding ME/CFS, we felt it would be useful to compare the two studies.
The committee that authored this report titled, “Chronic Multisymptom Illness in Gulf War Veterans” was formed in early 2013 and concluded their work in December of that same year. The Veterans Administration charge to this IOM committee was to “comprehensively review, evaluate, and summarize the available scientific and medical literature regarding symptoms for CMI among the 1991 Gulf War Veterans” in order to:
- Develop a research case definition and if possible, a clinical case definition for CMI (chronic multisymptom illness) as it pertains to the 1990-91 Gulf War veteran population and;
- Evaluate the terminology currently used in referring to CMI in Gulf War veterans and recommend appropriate usage.
Dr. Suzanne D. Vernon, the Association’s Scientific Director, was nominated and volunteered her time to serve on this committee along with Dr. Fred Friedberg, Stony Brook University and President of the IACFSME and 14 of their well-respected peers. See the full committee roster and bio sketches HERE.
This committee reviewed, evaluated and summarized the scientific and medical literature regarding the symptoms experienced by veterans involved in Operation Desert Shield and Operation Desert Storm from 1990-1991. Of the 2,033 unique publications the committee selected 718 for review and evaluation. The topics of these papers included mortality, hospitalization, neurologic symptoms, respiratory symptoms, gastrointestinal symptoms, pain, birth defects and fertility, cancer, mental health conditions and overlapping syndromes.
After rigorous evaluation and extensive deliberation, the committee made the following recommendations.
1) That the Department of Veteran Affairs consider the use of two existing definitions known as the Centers for Disease Control and Prevention (CDC) definition and the Kansas definition because these capture the most commonly reported symptoms.
- It is noteworthy that the committee did not develop a new research or clinical case definition. This is because many of the elements necessary to derive a case definition including onset, duration, severity and objective laboratory findings were lacking in the published literature. Further, the committee did not recommend one definition over the other because both captured the array of the most common symptoms experienced by Gulf War veterans.
2) That the Department of Veteran Affairs assess existing data that could be useful in describing symptom onset, duration, severity, frequency and exclusionary criteria to help with the development of more robust case definition criteria.
- This is important because of the gaps in the existing published evidence. It is challenging to develop a case definition if the necessary information to define a disease is not examined, is not available or does not exist. Therefore, review of existing data in ways that could possibly clarify case definition features like duration and symptom severity will help improve future iterations of both the CDC and Kansas definitions.
3) That the Department of Veteran Affairs use Gulf War Illness rather than chronic multisymptom illness to capture the population involved in the 1990-1991 conflict.
- Diseases may be named after specific events or geographic locations such as Legionnaires disease or the Spanish flu. The committee acknowledged the unique circumstances of the 1990-1991 Gulf War and the fact that Gulf War Illness has been used extensively in the medical and scientific literature.
In September 2013, the Department of Health and Human Services and the Social Security Administration contracted with the IOM to form a committee to evaluate ME/CFS diagnostic criteria. This has been the center of much debate among the ME/CFS population.
The specific charges to the ME/CFS committee are:
- Conduct a study to identify the evidence for various diagnostic clinical criteria of ME/CFS using a process with stakeholder input, including practicing clinicians and patients;
- Develop evidence-based clinical diagnostic criteria for ME/CFS for use by clinicians, using a consensus-building methodology;
- Recommend whether new terminology for ME/CFS should be adopted;
- Develop an outreach strategy to disseminate the definition nationwide to health professionals
While there are similarities in the charges to these two committees, there are differences as well.
- The IOM conducts studies by reviewing the published, existing evidence.
- In the case of the CMI committee, they only reviewed published evidence.
- The ME/CFS committee has asked stakeholders to provide data, some that may be yet unpublished. This is important as it may provide important new evidence for clinical diagnostic criteria.
- With the CMI committee there was insufficient evidence to justify the development of a new case definition for Gulf War Illness. Since the ME/CFS committee has access to new existing data and strong case definitions already exist, they may be in a better position regarding evidence-based diagnostic criteria.
- Both committees were charged with recommending new terminology.
- The CMI committee recommended use of the name Gulf War Illness for the reasons stated above.
- In the case of ME/CFS, their terminology recommendation remains to be seen.
- The CMI committee was not charged with developing an outreach strategy.
- However, the CMI committee recommendations were to the Department of Veterans Affairs; the agency decides how the CDC and Kansas definitions should be used in the research they conduct and fund. Consistent use and reporting of research using these case definitions will help build a robust evidence base to accelerate the discovery of objective biomarkers and treatments for veterans with Gulf War Illness.
- The ME/CFS committee is charged with developing an outreach strategy to get the information to health professional nationwide – hoping to meet a deep need in the community for more informed care.
In many of the arguments against the IOM Committee for ME/CFS, detractors have noted failing on the part of the IOM committee responsible for the report “Treatment of Chronic Multisymptom Illness”, this report is not the the one published today (March 12, 2014). The treatment report was based on review of the literature of veterans’ health involved from the 1990-1991 Desert Shield and Storm conflicts to active duty service members currently in the Gulf Region and the evidence for treatment of the chronic illnesses and the many varied medically unexplained symptoms they experience. Perhaps the greatest failing is the dearth of published evidence in the biomedical literature for treating serious diseases like Gulf War Illness.
Currently there is a lack of a widely accepted and recognized disease-defining concepts for the core signs, symptoms and decreasing functionality for ME/CFS. The Canadian Clinical Criteria has merit and at same time has not been widely distributed and uniformly accepted. The development of safe and effective treatments for ME/CFS require uniformly accepted criteria that can be used consistently by researchers, clinicians and patients. One of the reasons for the slow progress has been the lack of reliable clinical diagnostic criteria for ME/CFS, so the work now underway with the IOM ME/CFS committee could be a critical step forward for progress.
The New York Times calls the IOM the United States’ “most esteemed and authoritative adviser on issues of health and medicine, and its reports can transform medical thinking around the world.” Its mission is to serve as adviser to the nation to improve health. The Institute aims to provide unbiased, evidence-based, and authoritative information and advice concerning health and science policy to policy-makers, professionals, leaders in every sector of society, and the public at large.
The CFIDS Association continues to be cautiously optimistic about the IOM and the committee’s ability to have the impact necessary to make the disease-defining concepts of ME/CFS widely understood and available. The credibility and authority of something like the IOM – the health arm of the National Academy of Sciences – is critical to making ME/CFS widely recognized and diagnosed by the nation’s medical community. Something we all hope to see in the very near future.
Respectfully, I have to take issue with several statements made in this post.
Cort said that “ME/CFS has received much more study (Pub citations – GWS – 1764, CFS – 6200)” than Gulf War Illness. PubMed citations is only one way of measuring this. I would like to suggest that spending would be a better metric. For example, in 2013, Congress appropriated $20 MILLION for GWI through the Department of Defense. Source: http://cdmrp.army.mil/gwirp/default.shtml DoD funding was even higher in previous years, and that doesn’t count VA spending either. I would also point out that many of the population studies cited in the IOM report involved thousands of subjects. The VA study included almost 20,000 people, and other studies included in the range of 3,000.
Can you imagine what ME/CFS research would look like with $20 million a year, and studies of many thousands of patients?
Cort also said that ME/CFS has a “much, much stronger advocacy community.” Cort pointed out that one of the vocal critics of the IOM GWI case definition report does not have a website, and that a PR post is the top advocacy result in a Google search on the report.
I don’t deny that we have a strong advocacy community! But I think there are many ways to measure the strength of an advocacy community. For example, legislation was introduced in the House this past week to strengthen the independence of the VA’s advisory committee on GWI research. Source: http://www.usatoday.com/story/news/politics/2014/03/14/house-demands-independence-from-va-for-gulf-war-illness-advisory-board/6428299/ Despite all our efforts, we have not yet succeeded in getting ANY legislation introduced to improve CFSAC or authorize research funding or any other action beyond the annual budget report language. We’ve tried for years, and efforts are still ongoing. I’m not criticizing our efforts, but based on legislative action I think it’s clear that GWI is having more success than we are.
I think it’s really important to employ the right measurements and evidence to support our statements about ME/CFS research and advocacy. Based on the examples I cited above, I have to disagree with Cort’s statements that ME/CFS has been better researched and that our advocacy community is much much stronger. We have good research and a strong community, but by at least some measurements, GWI is ahead of us.
I agree with you about the relative effectiveness of the ME v. GWI advocacy groups. We are finally starting to push harder with HHS’ bosses- Congress and the President- and we need to keep upping the pressure with them. That is how GWI got some progress and it’s what we desperately need.
Cort- I googled both “‘James Gunn’ GWI'” and “‘James Gunn’ Gulf War” and got nothing. Did you mean James Binns? If so, he has been a very vocal critic of VA and IoM in all the USA Today articles and heads the Congressionally mandated Research Advisory Committee which has forced VA to do some valid research. We are way behind the Gulf War vets with stuff like that which is so important. Though, yes, I do agree we certainly have had more people being more vocal about our IoM process than they have. Yay us! Let’s keep it up!
Who cares what the NY Times thinks about the IOM, their thoughts are probably lobbied by the IOM. Isn’t the lead researcher for the IOM on CFS a post doctorate in Archeology- really important in our disease!
I don’t know how you can call the committee that the IOM used for the Gulf War Illness to be adequate? There are only 2 people that actually have gulf war research in their CV. What does a researcher of ALS from UCSF have to do with Gulf War Illness, much less Susan Vernon- hey I thought she had to leave her CFS role due to family “time constraints?”
From what I’ve seen the veterans are not at all happy that essentially nothing got done by the IOM and veterans are committing suicide in alarming numbers.
I still think the best thing would have been like the 70+ doctors asked- go with the Canadian Definition and spend the 1M on research.
Greg
You’ve all heard about people (in this committees) who — while the Titanic is sinking — are rearranging the deck chairs.
Well, these committees are DISCUSSING the DESCRIPTION of the REARRANGING of the deck chairs.
Doesn’t it just make you want to puke?
Yes…gag, gag, gag…
Suzanne Vernon — gag!!!
IOM — gag!!!
CAA — GAG, GAG, GAG!!!
‘Goes to show how DoD can blow millions in research money. It’s a shame that the work of Haley et. al. at UT Southwestern (part of which separated the vets by exposure and symptom set) went for total naught.
The “interest” of ALS docs might come from the 2001 reports that GWI vets got it at twice the normal population’s rate. Or not. There were several toxicologists/environmental types on the panel, but toxic exposures weren’t considered per the USA Today article below.
On one hand, this does no immediate further harm. On another, it’s blown money without any progress, and a punt back to an increasingly hostile VA which dissolved the GW Research Advisory Committee. Binns was the chairman of this supposedly independent oversight group. Unfortunately, CMI is now part of the VA lexicon for applying for disability (part of which is distinguishing GWI from CFS; go figure). And good luck getting more data when the VA “lost” what they had.
http://www.usatoday.com/story/news/nation/2014/03/12/new-iom-report-released-on-gulf-war-illness/6302909/
Having a nurse friend that came home from desert storm so ill she could not stand unassisted, could not get the benefits she should have gotten, because back then the understanding of GWI was not considered as qualifying for service rendered benefits, I am appalled that we have not made much progress. I suppose if they put it off long enough everyone will be dead. My first husband was in Vietnam, had testicular cancer, and it took three decades to get the government to admit agent orange was the cause. He FINALLY got health benefits through the VA because of it, but he dropped over dead from a heart attack the week before his first appointment. To say that we are taking care of those who put their lives on the line for us should be shameful.
All invisible disorders should be researched. No one of us has more rights than another. We must be careful not to compare our illness as more important than….. Of course, it is more important to us, but not anymore than Lupus is to SLE patients, MS, GWI, etc etc.
Thank you for raising awareness to another important community. We must stand together, because divided we fall.
While I understand the frustration and suspicion of many ME/CFS patients concerning the IOM, I believe this is a necessary process. Right now, we suffer from an illness that has been around for quite some time and yet does not have a proper name.
The FDA just announced its new policy allowing patient reported outcomes in clinical trials, yet they use ME, CFS and CFS/ME interchangeably. They also admitted they do not know what defines the illness. So in my opinion, the IOM work is an important first step. While many fear the worst based on past performance, and rightfully so, I think Cort made some important points regarding the composition of the committee that point to the possibility of a different outcome this time.
My feeling is that the deliberative process being undertaken will serve the best interest in the end, if that process is carried out with sincerity. I base that on my own experience in decision making. I tend to make better decisions when I gather as much information as possible, consider it, and then decide, as opposed to decisions made hastily.
A personal encounter with the VA. I went to the intake doctor. I said I had accidently eaten Malathion. She immediately ordered blood tests for T-cells. The report indicated a disruption in T-cells. I was referred to an internist who prescribed Klonopin. I said I was not depressed, I was inexplicably sick. I never saw an Immunologist. That was in the year 2000. Recently, disrupted T-cells are considered a biomarker for me/cfs and GWI.
This indicates that the VA knew insecticides disrupt immune systems long before they published the fact. Did the IOM committee include a VA expert?
This is ludicrous.
Incline Village was 1984. This is 2014.
They have had 30 years to arrive at anything but a hasty decision.
Thirty years!! And they’re still discussing what name to give it?
Just because medical leadership in the US collectively shoved the problem under the rug for 30 years is not an indication that they have gathered the wisdom over time to understand what they are dealing with. And because they chose to shove it under the rug for so long, we are skeptical. But there are some signs this process is trying to arrive at the right answer. Until it does, there will be skepticism. If it doesn’t, we have to continue to support each other as a community and show their gamesmanship to be irrelevant.
The whole IOM debacle has the imprint of psychiatrist Simon Wessely all over it, ‘get a bunch of non-experts together and ask them to define a complex disease’. He has been the bain of ME sufferers lives in the UK for decades, anything he is involved in ends up disastrous for the patient community. He has a long history of constantly moving the goal posts and name changing attempts of both Gulf war Syndrome and ME. He has a phenomenal network of influence, don’t underestimate this man, when he is around things go badly.
He was behind the name change of ME to CFS in the UK, the promise was “it’s purely for research purposes” years on and the ME title has been usurped, promises broken, and people are only diagnosed with CFS, the ME title demoted to a patients lay term. A break with the WHO neurological definition seems to be the purpose of the exercise. I expect CMI is not dead at all!
People pressure is very important and has brought about ME experts on the IOM panel. Perhaps the tide is turning the ME experts have a renewed sense of purpose and total commitment maybe we will end up with an unexpectedly good result, but I won’t hold my breath.
I completely agree!
And I don’t think this report was benign. It was just not a disaster; and that was probably mostly because of patients making an outcry.
The press release, and I am sure the report, judging from James Binns comments, was rife with the usual BS such as GWI being “medically unexplained.”
Suzanne Vernon, Fred Friedberg and their co-authors thank Simon Wessely for being a reviewer (reviewers are only revealed at the publication time of the report).
Vernon and Friedberg should have written dissents (which IoM publish in the reports) about all the BS.
Just a little background and disagreement on a couple of points in your otherwise good note, Cort.
The GWI community does not have any major websites that I know of other than the 91 Outcomes site http://www.91outcomes.com/ maintained by Anthony Hardie, a past member of the Research Advisory Committee on Gulf War Veterans Illnesses (RAC-GWVI) and the NGWRC site (National Gulf War Resources Center) http://ngwrc.org/ The GWI community does, however, have an extremely robust set of sites on Facebook, although most of the ones where activity on advocacy takes place are closed or private pages. We do plan lobbying activities, RAC rallies, press events, legislative proposals, internal organization, research study participation, and more on these pages.
The IOM committee that conducted the just-released report on a case definition for GWI (CMI) had no one with any experience treating or researching GWI. The VA severely restricted the charge to the IOM committee in terms of what research it was allowed to consider in its deliberations. There is much research that has been published and much more in progress that provides much of the information the IOM committee stated was missing. James Binn’s anger at the IOM report would have been (and he knows this) more properly aimed at the VA for their charge to the IOM, rather than at the committee for not reviewing research they weren’t charged with reviewing.
One commenter discussed the amount of money spent on GWI research, but that is not a reliable measure. The VA money over the past 20+ years has largely been spent on psychological-focused research, but about 40% or more by most counts has been spent on research not even related to GWI, or to buy equipment not related to GWI research. Many of the other GWI studies the VA has conducted have not even used GWI subjects in their studies. We believe less than 25% of the VA expenditures on so-called GWI research have actually been focused on GWI, and almost all of that has been focused on psychological causes of GWI, even after GWI was determined to be a physiological illness.
The DoD CDMRP GWIRP (Congressionally Directed Medical Research Program – Gulf War Illness Research Program) is one of the many DoD research programs conducted simply because Congress has told DoD to do the research. The CDMRP is the largest researcher of breast cancer of any program in the U.S. today, for example. http://cdmrp.army.mil The funding for the GWIRP has historically been hit or miss, but has been better the past few years, and all research is well controlled and evaluated through Assessment Panels (I sat on one of the FY13 panels) that rank the proposals for their efficacy, then by an Integration Panel that decides which proposals to fund for how much money. Our GWI advocacy groups were effective in ‘helping’ Congress decide to include GWIRP funding for FY13 and FY14.
I agree with you that the results of the IOM committee on the CMI case definition were reasonable. Especially considering there were no GWI experts on the panel and the charge was so limited. Changing the name back to GWI, while not particularly important in a medical sense, does get rid of the nebulous CMI terminology and establishes the illnesses as a distinct set of illnesses with a distinct cohort of sufferers. This is especially valuable for disability rating purposes. Not establishing a new case definition now leaves it open to researchers and experts in the GWI field to establish our own case definition through actual research development, which is the appropriate route to build such a definition.
Like you, I also believe the IOM Committee on ME/CFS, because of it’s large number of ME/CFS experts on the panel and the much larger, better defined research base, will be able to define the disease much more clearly than they were with GWI. I have faith they will start with the Canadian Criteria and use the best parts of the other extant criteria to craft a reasonable case definition for clinical practitioners. I also believe they will be able to establish a fitting and proper scientific name for the disease that, along with the outreach proposals, will finally fix in the minds of physicians that ME/CFS is a real, physiological disease with established diagnostic criteria, and established treatment methods.
Thank you again for your good summary of events!
Dr. Dave
Thanks Dave for all the info and pointing out the Facebook sites. (I have to stop thinking that Google search defines the internet :)). GWI and ME/CFS are in much the same boat with the low funding and often poor allocation of funds. I’ve always been struck that even vets – mostly young well-trained people in excellent physical shape – got pushed into the psych category. The pull to characterize disorders the medical community does not otherwise know how to deal with is incredibly strong.
Thanks again for our comments. 🙂