Credit: Cole Young*
Just over a year ago, advocate Leela Play noticed something odd on a federal contracting website. What she found was a notice of intent to award a sole source contract to the Institute of Medicine to create clinical diagnostic criteria for ME/CFS. And just like that, the ME/CFS landscape changed.
What followed was a month-long attempt to stop the government from issuing this contract, and when that failed more attempts were made to get the contract rescinded. The advocacy and scientific communities faced divisions over positions and tactics. Meanwhile, the IOM contract has moved towards its conclusion in March 2015.
Current activity – both IOM and advocacy – is smoldering underground. But no one should mistake this period of quiet to mean that nothing is happening.
Where Is IOM?
The process and schedule for this IOM study is set forth in the contract, and is moving pretty much on track. The committee was selected in December 2013, and held two public listening sessions (January and May 2014). The committee has met behind closed doors four times, with a fifth meeting scheduled for this week. Bare bones meeting summaries are posted on the project website after the meetings.
Committee members have reviewed a great volume of material. An extensive literature search has been conducted. In addition, the public has submitted comments and materials over the course of the contract, numbering more than 4,000 pages the last time I checked. There are also indications that the committee may have examined raw data, although details about that are not yet available.
The study seems to be running slightly ahead of the schedule laid out in the contract, at least judging from the meeting dates. If so, then it means the committee is putting the finishing touches on its recommendations and the case definition. The next step is sending the draft report out for peer review, with delivery on track for early 2015.
Where Are We?
As reflected on this and other blogs, discussion forums, and social media, ME/CFS advocacy exploded when we learned about the contract. I’ve compared it to dropping a match on a lake of gasoline. For the most part, we focused our attention outward towards the government, IOM and the media. But at various times, we’ve also focused attention inward. We’ve criticized each other for our positions on the contract, the degree to which we have participated in the process, and for the tactics we’ve used. Sometimes, the criticism has not been constructive. This is not unexpected when people feel cornered and the stakes are high.
DHHS stated at the June 2014 CFS Advisory Committee meeting that it wants to work with the advocacy community on a path forward after the IOM report. As I wrote in my meeting summary, if this “means the kind of involvement we have had to date, then there is nothing to really talk about.” HHS holds all the cards here, and it will take more than token efforts on both sides to actually move forward together. Obviously, this begs the question of whether ME/CFS advocates will even want to move forward with the IOM report. It all depends on what that report says.
What Next?
I think one possible analogy for where we are now is the Centralia mine fire. This fire has been burning in a coal seam beneath the town of Centralia, Pennsylvania for 52 years. Underground coal fires can burn for years undetected. Eventually, the ground collapses in sinkholes, allowing oxygen to rush in and fuel the fire even more.
On the surface, it may not seem like advocates are paying much attention to the IOM study right now. A number of prominent voices in our community have retired (temporarily, I hope) or taken breaks to recover from the crashes brought on by advocacy. The scientific community has not been publicly discussing IOM. And the IOM committee members themselves are bound by very strict confidentiality rules, so they’re not talking either.
Don’t let the quiet fool you. Work has continued on multiple fronts this year, and I expect we will hear developments in the near future. It won’t take much disturbance on the surface to refuel this fire. A sink hole, some oxygen, and we’ll be at it again. What I’m wondering these days is who is going to get burned.
*Photo credit: Cole Young, Flickr, Creative Commons license
Thanks, Jennie (and to all who do so much), for being a guide in this ever-shifting labyrinth. (Fire-retardant psyche required for this “ride”.)
I must admit, that I don’t understand why the hostility to the IOM contract. The situation seems pretty straight forward to me: different groups want different definitions of ME/CFS. Each group is completely entrenched in their position, and will not give it up for anything. So the NIH brings in outside experts (IOM), who have a lot of prestige, but no particular axe to grind, and tells them to sort it out. Seems like the perfect solution to me.
But the patient group goes nuts; absolutely nuts about it. They seem to be arguing that you must choose their side (ie. CCC/ICC), without bringing in any outside experts or doing any new evaluation. No other solution is acceptable. But that makes no sense. The current situation is a stalemate. Just choosing one side is not going to convince the other side to accept it.
Patients should be cheering that the NIH has bought in an outside group (the IOM) with enough “technical weight” to get a new definition of ME/CFS accepted by researchers. It’s a huge opportunity, and the patient community is squandering it by insisting that it’s their way or the highway.
Finally, this makes the patients (and the experts who are also lobbying for ICC) look like the are in a weak position and they know it. If they thought the ICC was really the best definition, they would be happy to have the IOM evaluate it. But by trying to short-circuit the decision making process (don’t evaluate both sides, just choose our side!), they make it look like they don’t believe that the science will support them.
GKGK
GKGK, there is a lot I could say on this topic. If you are interested in more details, you could take a look at my blog archives from September and October last year when a lot of this was going down. But I’ll try to address your questions briefly.
The IOM has a very prestigious reputation, generally speaking. You are right that on the face of it, turning to such an institution to resolve a dispute over case definition seems like a good idea. But – BUT – it’s not that straightforward.
Patients (myself included) were shocked, angered and insulted with how HHS pursued this contract – completely in secret. We now know that HHS spent months on the idea, reaching out to different agencies to help pay for it and creating the Statement of Work, and it was completely locked down. The only outsider who knew about it was Dr. Gailen Marshall, then chair of the CFS Advisory Committee. And it wasn’t even sprung on us with a surprise announcement. WE found out about the contract by accident. And when we objected, HHS reacted uniformly defensively and secretively, pulling the contract notice without announcement and then pursuing another contract mechanism, again without announcement – despite several opportunities for them to pause and bring us into the loop.
If that was the only complaint, then I would agree that it was a tempest in a tea pot. But we were not just concerned about the secret and defensive behavior of a few federal officials. The IOM, as of September 2013, had never done a clinical case definition before. Ever. Why engage a body that has no experience in doing what you’re asking them to do? There was one precedent contract, the case definition for Gulf War Illness. IOM issued its report on that project early this year, and their answer was basically: we don’t have enough information to come up with a new case definition so use existing option A or B. This track record inspired no confidence in IOM’s ability to successfully perform this task, and HHS did absolutely nothing to address our concerns about this.
IOM does have precedent on CFS. CFS is mentioned in multiple reports on Gulf War Illness, including the most recent one, and each time the IOM panel has given credence to the psychosocial school of CFS.
Finally, we were deeply concerned – based on those previous statements about CFS and based on the lack of experience in creating a case definition – that IOM would assemble a panel that would include only a token expert or two, and multiple members of the psychosocial school. This would have been disastrous, because that would not have been an impartial or bias-free group at all. This disease, and its literature, is so complicated and there is so much disagreement, that actual disease expertise was essential. It turned out that the panel was 50-50. Seven members are ME/CFS experts, seven are new (or somewhat new) to the disease, and one has no professional expertise but has a son who is very very ill with the disease. A group of advocates, including myself, did a lot of work to check out the appointed members, and we had concerns about several of them. However, those three people were kept on the committee.
So that’s a super quick review of why advocates have objected to the contract so sharply. There is more than enough criticism to go around all sides of the controversy, and there is a great deal of merit in many of the positions taken as well.
Thank you for explaining what is going on as I am too brain dead to follow much but am making my best effort. Thank you for being our voice! I would like to know where to sign up for the M.E. revolt against the government? 😉 I’m only half-joking. Let me know if you know of any way I can help. brendahankins@gmail.com
Brenda, there are several patient forums online where people discuss advocacy actions to take. Phoenix Rising and me/cfs forums are two examples. I’ve also forwarded your email to one advocate I know who is working on some projects for next year. And watch this space, because I try to keep people informed of opportunities for public comment and ways to speak out to the government. Welcome to the fray!
Thank you Jennie for helping me get involved.
@Brenda Hankins
Brenda, in addition to the forums if you are on TWITTER there are Saturday TWEETSTORM protests directed @, for example, Dr. Francis Collins, Director of NIH–calling for the stoppage of P2P–an arm of IOM–HHS!! This is ONgoing especially on SaturdayS–but also goes through the week.
#StopP2P4ME
MECFSforums is especially advocacy based.
@GKGK
Also to note, that there is a Whistleblower, Dr. Thompson of the CDC, with explosive news about Vaccines and Autism–IOM worked on that too–saying all was OK–IOM was GIVEN the MISinformation by HHS.
You won’t find this in mainstream media as there is a news blackout there.
This is all a POLITICAL pot with MASSIVE cover-ups — resulting in the destruction of millions of lives over VARIOUS serious illnesses!
I’m skipping over the secrecy issues, because I agree with you that its a secondary issue, and I want to focus on the primary issue: is IOM the right organization for the job, and will they be unbiased? And also because I agree with you that the NIH secrecy was bad.
At first you say that IOM doesn’t have the expertise for this because they have not done it before, which I think is a silly argument, but then you switch completely, and say they have done it for Gulf War Syndrome. You summarize that effort this way:
“There was one precedent contract, the case definition for Gulf War Illness. IOM issued its report on that project early this year, and their answer was basically: we don’t have enough information to come up with a new case definition so use existing option A or B.”
So how does that show that IOM is bad or biased? I think that most medical experts tend to agree that Gulf War Illness does not have a good case definition. While you will find some fringe doctors who think it is caused by (poison gas, stress, vaccines, mold, untested drugs, hysteria, nerve agent antidotes, or about 100 other things), the current consensus is that the IOM was right to do what they did. I think it would be a great idea to revisit the accuracy of their conclusions in 5 or 10 years, to see if it is still the consensus opinion, but right now, it is.
But I want to spend most of my space addressing your last big paragraph: who is on the committee, and who you were afraid would be on it. When there is scientific controversy, there are two ways to create a fair committee. One is to have the committee be entirely neutral, and the other is to have some proponents of one idea, some proponents of the other idea, and more than half be neutral. The second one is the normal scientific committee to resolve contentious issues. The first is the “jury model”. The IOM has ended up with the second option, which you have objected to strongly. You claim that the committee should only contain people who agree with you, although you seem to accept neutral members, although you say that ME/CFS is too complex for them to be effective. (That was your point about trying to get those three people kicked out.)
Now what message does that send to the scientific world? Well, it sends the message that you know you can not prove your case. If you could prove your case, then you’d be happy with something like 25% proponents, 25% opponents, and 50% neutral, because you know your proponents would convince the neutrals they were right. That is what scientific consensus is all about. However, it’s clear that you know you don’t have the evidence. That you know your opponents (if any are on the committee) will convince the neutrals, and you’ll loose. (Your hatred of the “jury model” also shows this. In a jury model, everyone is neutral, and everyone is a scientific researcher, so if the science supported you, it would be a slam dunk. But you know it’s not. This is why you need to lobby to have your opponents removed (even if a minority of the committee, and even if balanced out by your proponents).
I did read your blog posting where you complained about the three members of the IOM committee that you wanted kicked out. And it made it very clear that you are a hypocrite when it came to conflicts of interest. Two of the doctors had each published a paper that contained very vague quotes that you didn’t like. The third had published a paper (13 years ago) which came to a conclusion about ME/CFS that you did not agree with. Compare that to your supporters on the committee, some of whom signed a document just recently, pre-judging the IOM’s work! That’s much bigger bias, and much more recent. If you are going to kick people off the committee for publishing vague statements you don’t like many years ago, then surely you need to kick out these guys who show much stronger bias, much more recently. But of course, they support you, so you ignore their bias.
Seriously, go re-read your paragraphs on Alegria, Ganiats, and Mulrow, and compare what they wrote to what Bateman and Klimas have written. Indeed, what many of the other panelists have written.
Your basic argument, when described in neutral terms, goes like this: 1. neutral people don’t know enough about ME/CFS to be effective. 2. People who agree with us are experts and should be on the committee. 3. People who don’t agree with us are not experts and should be on the committee, and they have conflicts of interest as well, which our experts don’t have. Obviously, this is silly and biased. I would be tempted to say that it’s going to destroy your credibility in the medical world, but I suspect it is too late to worry about that.
Of course, the whole point of the scientific method, is that you can take knowledgeable people, which the IOM is full of, and give them scientific evidence, and they can come to the right decision. A different groups of scientists would come to the same conclusion, because they’re all using the same scientific method and evidence. So when you argue that the neutral scientists (especially members of the IOM), can’t be effective on the committee, it’s hard to take you seriously.
I know that the ME/CFS world thinks that experts are people who agree with them, and non-experts are people who don’t. However, in the world of medicine and science, an expert is someone who has published a lot, and is generally found to be accurate in the past. That’s why I use the terminology of “experts who agree with you” and “experts who don’t”. If you look at these things unemotionally — very hard, I know — it is obvious that people like Wessely are experts. They have published widely and are well regarded, and their theories have supporting evidence. On the other hand people like Mikovitz are not experts (even if they agree with you). She has been the lead author for only one paper on ME/CFS and it was retracted! That’s a sign of failure.
In a certain sense, treating Mikovitz like an expert shows how desperate things are. She never saw patients, and her only research (that she led) was fatally flawed and was retracted. To have such a person be one of your 50 experts, really shows how low the bar is. I’ve never treated an ME/CFS patient. I’ve never been the lead author of a ME/CFS paper, but I’ve never had one retracted, either. Am I more of an expert than Mikovitz? If I said — loudly and repeatedly — that ME was a biological disease and not a psychiatric one, then would I be an expert, like Mikovitz?
GKGK
I’ve let your comment through moderation so we can discuss the points you raise, even though I do not appreciate being called a hypocrite, unscientific, and silly.
“At first you say that IOM doesn’t have the expertise for this because they have not done it before, which I think is a silly argument”
This is not a silly argument, which is why it was repeated so often during the early phases of the contract. Creating case definitions is not like using a cake mix. Epidemiology, statistics, taxonomy, etiology, and clinical expertise are all necessary skills to bring to a case definition process. This is why, of course, so many other diseases – even difficult to define diseases – have their case definitions created by the experts. The IOM Gulf War contract was ongoing at the time of the ME/CFS contract announcement, and the process was not finished. We had no basis at that point to judge how well the IOM would run a case definition contract. In fact, that Gulf War effort was controversial because the original panel only included a couple experts on the disease. Gulf War advocates strenuously objected and additional experts were added. We do not need or deserve a shake and bake approach to case definition, especially given the harm already caused by the use of multiple and varied case definitions thus far.
“So how does [the Gulf War case definition report] that show that IOM is bad or biased? I think that most medical experts tend to agree that Gulf War Illness does not have a good case definition.”
I did not say that the Gulf War report was wrong in admitting that there was not enough evidence to construct a new case definition. I pointed to that as a possible danger for us. The datasets evaluated in the Gulf War report are tens of thousands of patients and MUCH bigger than our datasets. So if tens of thousands of data points do not provide enough to create a new case definition, then ME/CFS could very well be screwed. And in that case, I think it is legitimate to question whether spending $1,000,000 on “we can’t do it” is better than spending $1,000,000 on a definitive study that will produce the necessary data.
“You claim that the committee should only contain people who agree with you, although you seem to accept neutral members, although you say that ME/CFS is too complex for them to be effective.”
Nope, I do not believe and did not claim the committee should only contain people who agree with me. Nor do I believe that ME/CFS is too complex for “neutrals” to be effective. What I do believe is that the ME/CFS scientific literature and clinical presentation is extraordinarily complex, contaminated by the multiple case definitions, and that “neutral” may not actually be neutral. CDC data show that 85% of doctors in this country believe that ME/CFS is wholly or partially psychological. That is not neutral. That is a bias.
“Your hatred of the “jury model” also shows this.”
A hilarious accusation, considering the fact that I was a litigation attorney before I got sick.
“And it made it very clear that you are a hypocrite when it came to conflicts of interest.”
No. I documented my concerns about Alegria, Ganiats and Mulrow quite thoroughly. My concern boiled down to a preconception on their parts that ME/CFS was a psychological illness/poor coping skills best treated with CBT/GET. This point of view would be detrimental to creating a valid clinical case definition for a disease that is physiological, not psychological.
“If you are going to kick people off the committee for publishing vague statements you don’t like many years ago, then surely you need to kick out these guys who show much stronger bias, much more recently.”
Regarding the letter signed by the 50 experts (Dr. Bateman had removed her name from that, by the way), I worried that signing the letter would be viewed as a conflict of interest by IOM. I worried that the experts who signed the letter would not be selected for the committee. I was pleasantly surprised when some of them were, and also very glad that some experts who did not sign the letter were chosen (Bateman, Rowe and Natelson, for example).
“Your basic argument, when described in neutral terms, goes like this: 1. neutral people don’t know enough about ME/CFS to be effective. 2. People who agree with us are experts and should be on the committee. 3. People who don’t agree with us are not experts and should be on the committee, and they have conflicts of interest as well, which our experts don’t have. Obviously, this is silly and biased. I would be tempted to say that it’s going to destroy your credibility in the medical world, but I suspect it is too late to worry about that.”
Indeed, if this was my argument then it would be silly and biased. But that was not and is not my argument. Neutral people are fine, if they are willing to master the literature. Neutral people who actually have preconceptions that may bias their judgment are dangerous. I do not equate expertise with whether someone agrees with me. There are points of view on that committee – from experts – that I do not agree with. Expertise in ME/CFS comes from a demonstrated history of publications and/or clinical care. Regarding my credibility in the medical world, I assume that everyone makes their own judgment about my credibility, just as you have.
“Of course, the whole point of the scientific method, is that you can take knowledgeable people, which the IOM is full of, and give them scientific evidence, and they can come to the right decision. A different groups of scientists would come to the same conclusion, because they’re all using the same scientific method and evidence.”
I agree that IOM is full of knowledgeable people. And it is my sincere and strong hope that this particular group will examine the scientific evidence and come to the right decision. I do not believe that a different group of scientists would automatically come to the same conclusion, though, because the evidence here is not just hard data (although that’s part of it). There is a clinical knowledge base that is equally important. And the last 30 years of ME/CFS history are overflowing with examples of different groups examining the same evidence and coming to different conclusions. This is not a hard math equation. There is human judgment at play, too.
“it is obvious that people like Wessely are experts. They have published widely and are well regarded, and their theories have supporting evidence.”
Unlike many readers of this blog, I agree that Wesseley is an expert. But an expert in what? He is an expert in Oxford definition CFS. But Oxford CFS is not the disease I have. I don’t see any evidence that Wesseley is an expert in a disease characterized by post-exertional malaise, sleep disturbance and cognitive dysfunction, nor do I see any evidence that he understands the 2 day CPET data in ME/CFS patients (as just one example).
“In a certain sense, treating Mikovitz like an expert shows how desperate things are.”
I can’t tell from your comment if you have me confused with someone who believes Dr. Mikovits is a world renowned expert on ME/CFS. She claims to be, and many ME/CFS advocates believe her to be. But I’ve been publicly critical of some of Dr. Mikovits’ statements, and have taken quite a bit of heat for that.
The fears and concerns I had when the IOM contract was announced, and when the panel was announced, boil down to whether bias towards the psychosocial view of ME/CFS would contaminate the panel’s work. In reality, I think IOM did a good job in creating a balanced panel. There are patients/family members, clinicians with decades of experience treating ME/CFS patients, researchers with varied approaches to studying ME/CFS, and clinicians/researchers with no direct expertise who brought other relevant knowledge to the table. I remain concerned about potential bias in several members, but I actually agree with you that we can trust the ME/CFS experts to be vocal in addressing those types of questions and concerns.
Whatever the final report looks like, I will address it on its merits. I will not accuse its authors of being silly, hypocritical, biased, or untrustworthy. I expect the same courtesy from those who choose to share their opinions here, regardless of whether we agree or not.
@GKGK
Interesting how you believe WESSELY is an expert on ME/CFS. This says it all loudly and clearly!
QUOTE
If you look at these things unemotionally — very hard, I know — it is obvious that people like Wessely are experts. They have published widely and are well regarded, and their theories have supporting evidence. On the other hand people like Mikovitz are not experts (even if they agree with you). She has been the lead author for only one paper on ME/CFS and it was retracted! That’s a sign of failure.
UNQUOTE
@GKGK
You stated:
“Of course, the whole point of the scientific method, is that you can take knowledgeable people, which the IOM is full of, and give them scientific evidence, and they can come to the right decision.”
I’d say that the scientific method also demands that you carefully define the subjects of investigation if you want your research to make sense. If your objective is to study the breeding habits of blue birds, you don’t throw in some dragonflies and flying fish simply because they also lay eggs and fly.
But that’s exactly the problem with this field – disparate definitions all masquerading under the same “CFS” label.
For instance, the Oxford CFS definition only requires medically unexplained chronic fatigue lasting 6 months or more. It does not require hallmark criteria like post-exertional malaise. It allows primary psychiatric illness. According to Oxford, a CFS diagnosis depends solely on a common, ill-defined and difficult to measure symptom and the current state of medical knowledge and it can also encompass both mental and physical disorders. How many diseases and conditions can you think of that could end up under the “CFS” umbrella? How many of them have any biological relation to each other? What will your resulting study be capable of demonstrating?
Fukuda and Empirical CFS definitions are almost as bad. Patients prefer CCC and the ME-ICC not because of some emotional preference but because they are the only ones available today that actually describe the disease that patients have by requiring hallmark criteria. No flying fish or dragonflies allowed.
Regarding knowledgeable people looking at the evidence and coming to the right decision – the majority of systematic evidence reviews done for this disease, both historic and ongoing, have merged studies across definitions solely on the basis of medically unexplained chronic fatigue without ever asking if those definitions all represent the same disease or not. Knowledge in another area is not always enough to surmount biases, misperceptions, attitudes and a lack of deep familiarity of what in this case is a remarkably polluted evidence base.
It’s repeated experiences like that that have patients concerned