Lenny Jason has taken the IOM Report ” “Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness” to task in two published articles.
In his first article, Jason decried the restrictions the IOM process put on collaboration. He argued that the process of creating a new name for chronic fatigue syndrome should have involved all the stakeholders in the disease.
In the most recent article “The IOM’s Effort to Dislodge Chronic Fatigue Syndrome” Jason questioned the makeup of two of the secondary criteria and argued that the committee should have used statistical analyses to assess the criteria before publishing them. He also asserted that people with primary affective disorders – people whose primary illness is a mood disorder and who also meet the criteria for ME/CFS – should have been excluded.
Jason has argued for years that a poor definition has thwarted us from making progress in virtually every important area. Defining ME/CFS correctly, he’s asserted, is one area we must devote more resources to. He is, in fact, our only expert on defining ME/CFS and naming it, and has published in both areas – the first extensively. He seemed like a natural fit for the committee. I asked him why he was not on it?
He gave a brief answer to what he said was a complicated question– that he had signed the petition opposing the IOM process, and given that, he felt that he could not be on the committee.
He also noted that if he’d been contacted he might have been able to resolve some important issues.
“First, the task of writing a formula to test the new case definition took about one hour, and a large data set was analyzed in about 2 more hours by a member of our team. Had the IOM asked me to compare their criteria with others, we could have done this easily, and provided them the outcomes. Could it have informed their work; my guess is that it would have.
However, until the report was released, we had no idea what new criteria were being proposed. I had minimum contact with the committee members as they were not to speak to anyone about their work. I think that this works fine for most IOM products, but in our community, this was probably not the best way to build a consensus for a new name and case definition.” Lenny Jason – pers. communication
Contact with people outside the committee is clearly not permitted by the IOM. The consensus they form comes from within the committee.
“the committee works independently to come to consensus on the questions raised. In fact, while the committees may gather information from many sources in public meetings, they carry out their deliberations in private in order to avoid any external influence” IOM
Jason has twice asserted, however, that in this instance, the IOM committee should have gone “rogue” and disregarded their mandate and reached out to the public and researchers.
“However, the patient and scientific community could have been actively involved in selecting the case definition and its criteria prior to the dissemination effort. This involvement would represent a departure from the process that has historically existed.” Lenny Jason
The consequences of stepping outside a longstanding process are unclear but doing it would have been risky. Would it have been worth it to take the risk?
My guess is no. The IOM process does not by design embrace outside collaboration. It is purposefully limited to the participation of selected experts. If that sounds elitist, it’s also its strength. The IOM process puts a premium on producing rigorous and objective analyses by gathering experts, and then by creating a sealed environment that limits the impact of outside influences. That process is a key reason the IOM – in existence since 1970 – is so well regarded.
Contravening that process might have, in this instance, resulted in a better report. It also, however, could have resulted in the report being terminated and would have blunted its legitimacy and impact as well.
If Lenny Jason had been a part of the committee, his voice would have been heard. He would have been able to test different iterations of the criteria, and I think he would have been able to resolve the issues that troubled him.
I don’t think outreach was needed to create the best criteria for ME/CFS. I think Lenny Jason was needed, but unfortunately he removed himself from participating in the process. That process appears to be over.
What To Do Now?
Now that we have criteria our sole expert in the field disagrees with what do we do now? I imagine Lenny Jason’s upcoming studies will indicate the criteria has some flaws. What to do about that?
I don’t know if the diagnostic criteria changes are possible at this point. The IOM is probably not, after a year or so working on this document, willing or perhaps even able to revisit the criteria. A finished report has been presented to the public. Can changes be made? I don’t know.
If the criteria are set, the big question is whether these criteria are an improvement or a step backwards? In my mind, there’s no question that, whatever their flaws, they’re a considerable step forward from the Fukuda criteria and the Canadian Consensus Criteria. We may not have gotten the best criteria, but expecting that, given we didn’t have our top guy in there, was probably in retrospect, unrealistic. Instead, we got much-improved criteria.
I think Jason was obligated, once he saw issues in the IOM report, to bring them up, and his insights will surely be helpful. Next time, though, hopefully, he’ll situate himself inside the process. That’s where the ME/CFS community needs him. Among other things, a community with few resources and many needs simply needs to be as efficient as possible.
Now we have something of a mess: we have our only expert disagreeing with key facets of a federally produced report that was supposed to point the way towards a new approach to this disorder. This, we didn’t need.
A Bigger, Better Process – Next Time
If we had the means to start over should we? Should we try to get the federal government to do that? Would that be a good use of our resources?
My guess is no. I trust Lenny Jason. My guess is that he’s probably right, but I also believe that the criteria are probably also good enough. We had very smart people working on them.
With this field still in flux the criteria were expected to be temporary placeholders until the appropriate studies were done. They can stand.
Meanwhile, our resources remain very limited. The IOM and P2P reports are the first significant projects the federal government has taken on since the State of the Knowledge Workshop in 2012. Before that we have to go back to the Neuroimmune Conference of 2003, I think it was, and the following RFA, to find anything significant.
Let’s not let the perfect be the enemy of the good. This process was never going to be ideal. The federal government is not at the point where it funds “ideal” in ME/CFS. Comprehensive examinations of any subject are going to be rare.
For now, though, let’s spend our very limited political capital where it can do the most good: on increasing research funding, getting Centers of Excellence and finding a home in an Institute. The next time the name and definition come up for change hopefully we’ll have the clout to give the process the attention it deserves.