Phoenix Rising: A Chronic Fatigue Syndrome (ME/CFS) Newsletter (Dec 2008)CFIDS Association of America / CDC: Round II By Cort Johnson
Chronic Fatigue Syndrome (ME/CFS) News
Dubbo Studies in the News – On the heels of a possible breakthrough in our understanding what happens in early stages of this disease Dubbo researchers got some rare television airtime on ABC news in Australia. (A transcript is also available). An interview with Dr. Voller-Conna about this study and the Dubbo groups ideas on ME/CFS is in the works.
New Physician Training Program Enjoys Amazing Success! – Not satisfied with the CDC’s physician education program the CFIDS Association of America created one of its own and got Medscape to host it in October. The results from the first three months are in and they’re good! If this program takes off it could make a big difference in how people with this disease are treated. Created by ME/CFS physicians. Check the report out here and the program here.
Chronic Fatigue Syndrome Congressional Briefing Posted on YouTube – Scott Simon of NPR brought the house down as -standing in for Lauren Hillenbrandt of SeaBiscuit fame – he emplored Congressional staffers to help us out. Check it out
The Complete November CFSAC Minutes Are Available; Check out our representatives as they confer about the CAA’s recent report on the CAA and many other issues.
Two Weeks Left to Register for the IACFS/ME Conference in Reno in March at reduced rates.
Chronic Fatigue Syndrome (ME/CFS) Research and Events
CFIDS Association of America/Centers of Disease Control: Round II
Kim McCleary’s testimony alleging incompetence at the CDC was too riveting for federal advisory committee (CFSAC) to simply close up shop. They postponed adjournment, called her back and addressed some issues she had raised. The following discussion opened some new ground for us on this issue.
Some History. Kim McCleary, the CAA’s president, got a closer look at the CDC’s effort last year whenshe served on a blue ribbon panel at the agency. At that time it seemed to her and others that the CDC was getting too little bang for their buck. The CAA first broached the subject of the program’s productivity with the program itself. Failing to get satisfactory answers there they approached the CDC leadership using Sen. Jack Reed of Rhode Island’s office to facilitate discussions. Apparently failing to get the result they wanted there they finally took their concerns public – just before an external review of the program began.
Dig Deeper! Kim McCleary’s Testimony to the CFSAC
Kim McCleary made it clear that the CAA is focused on one and only one aspect of the CDC’s CFS program – it’s leader but she also questioned several other aspects of the program including the creation of a controversial new definition and the overall focus of the program including its lack of work on a biomarker. She noted how startling it was to visit Japan and see a Japanese team with 20% of the CDC’s budget producing amazing results.
“it’s not a lack of resources at the CDC, it’s a lack of leadership.” Kim McCleary
A Time of Opportunity… and Danger – The CAA has raised these issues at a particularly interesting time. The CDC’s CFS program is currently undergoing both internal and external reviews and the entire program will be moved to another, still unannounced, section of the CDC. Reorganizations have not gone well for ME/CFS programs in the past. The reorganization of the NIH’s CFS research program seven years ago resulted in it being moved from a powerful, money-rich Institute to a small, poor Office. The three active federal research centers closed and research funding dropped dramatically and seven years later shows no signs of rebounding.
Dr. Klimas immediately brought up the ‘doomsday scenario’: the ME/CFS program being dismantled but it’s hard to imagine that that could happen and Dr. Miller (from the CDC) stated that that was not a possibility. ” God forbid… the program be dismantled…the basic science… is just phenomenal… and the laboratory strength is really good” Dr. Nancy Klimas Indeed it’s hard to end a program but on the other hand its quite easy to put a program in a situation that causes it to lapse over time into mediocrity. In 2002 a new uniquely multidisciplinary ME/CFS program was announced at the NIH with great fanfare and hope, but was ultimately poisoned by a lack of support and an untenable structure. The patient community, largely unaware of the issues, hardly raised an eyebrow as our most productive research centers were closed down and an important program languished.
A Bird in the Hand – Dr. Reeves’ Tenure; 
Given the uncertain nature of what may lie ahead, let’s take a quick look at what we’ve had with Dr. Reeves’ leadership. The program was in disarray when he took over with the institution having used funds specifically allotted to CFS research for other purposes and then lying about it. It’s safe to say that the disease enjoyed little credibility at that point.
Ten years later ME/CFS enjoys greatly increased credibility in the medical world and the CDC program played a large part in that. The team’s innovative, cutting-edge techniques and its willingness to collaborate resulted in a signature event in ME/CFS history: the simultaneous publication of 14 papers in the Pharmacogenomics journal in 2006. Coincident with that the head of the CDC proclaimed, at a national press conference, that ME/CFS is a serious and legitimate disorder and announced that the CDC would fund, for the first time in its existence, a media campaign designed to increase awareness about an illness. Those events got the medical community to sit up and begin to pay attention.
Dr. Reeves introduced two controversial aspects to the program: a reliance on expensive random sampling procedures and a radically different definition of ME/CFS that appears, as yet, to have won little acceptance in the research community. At a time when a significant portion of the ME/CFS professional community was starting to emphasize post-exertional malaise in ME/CFS, Dr. Reeves pushed that symptom off the map, replaced fatigue with a more anomalous term (‘unwellness’) and included emotional distress as a significant element for the first time. Not surprisingly the CDC’s figures of “CFS” prevalence jumped fourfold – raising questions regarding what kinds of people were being labeled with CFS.
Many questions could be asked whether the program’s funds have been spent wisely but it’s clear that Dr. Reeves is interested in and committed to this subject, and judging from Dr. Klimas’s and others comments, he has assembled a talented team around him. Contrary to most patients’ perception, psychological studies have, at least up until this point, have made up a small portion of CDC’s research program. Whatever its past successes the CAA’s charges suggest that the program has badly faltered in the last several years.
Researchers Chime In – Several researchers were quite troubled by Kim McCleary’s report. Dr. Snell of the Pacific Fatigue Lab stated, “As somebody who works on a shoestring budget, when I look at some of these numbers I was somewhat appalled”. After initially defending the program, Dr. Klimas, a longtime collaborator with the CDC, closed with a sharp and personal retort. After having an interagency Defense Department/CDC project funding get cut off twice by the CDC in midstream, Dr. Klimas stated “I don’t want to go back and collaborate with the CDC because it’s the second time I had the plug pulled on the study in the last year. It’s embarrassing….There’s something wrong”. These are strong words from a researcher with close ties to the program.
“I don’t want to go back and collaborate with the CDC” Dr. Nancy Klimas
Dr. Reeves leaves, the greatest danger is probably a new leader who is not committed to this field. It’s been hard to find enthusiastic, committed researchers in the federal establishment and one wonders where in the CDC (if not within the team itself) such a leader can be found. Dr. Vernon would have been an obvious choice but she’s no longer with the program.
The program is at a crossroads: we don’t know where it will end up and who ultimately will be responsible for it, and if the CAA’s accusations have cut deeply enough, we’re not sure who might be leading it. The resignation of the head of the CDC, Dr. Gerberding, who was considered a friend to ME/CFS – but who still allowed the programs funding to languish – further complicates the programs standing.
Rather remarkably, we got another look at the state of the ME/CFS program from a panel of well-known researchers.
ME/CFS (Chronic Fatigue Syndrome) Experts Punt on External Review
“I’m kind of struck by the issue that there’s this extraordinary opportunity next week to do an external review of an important organization”
Dr. Jason, November, CFSAC Meeting
Extraordinary Opportunity. Reviews of the CDC’s chronic fatigue syndrome research program come along about once every ten years and news that ME/CFS experts would critique the CDC’s ME/CFS program had the CFSAC committee practically salivating at the bit last May. As they tried to assemble a review team the CFIDS Association of America was already hard at work doing a review of their own. Basically we had two review committees going on at the same time; one spent hard earned political capital to force the program to open up its books, the other was invited in. One spent a year digging into the issue; the other spent a couple of days on a hand-guided tour of the program. Not surprisingly they came to rather different conclusions.
The panel , which ended up looking quite a bit different than what the CFSAC recommended , consisted of well-known figures such as Anthony Komaroff, Gudrun Lange, Peter White and James Oleske. (Dr. Oleske, the chairman of the CFSAC, missed the review (and the last CFSAC meeting)).
The panel noted the accomplishments of the CDC’s CFS research program and there are many: the innovative nature of much of its work, the many peer-reviewed papers, the studies elucidating prevalence, economic costs, the outside collaborations, etc. They felt the group had a high level of intellectual rigor, that communication lines within the group were open and that the level of dedication was high. The CDC deserves high marks for interesting a major University (Emory) in ME/CFS research. The panel was particularly impressed with group morale – a good sign given the program’s uncertain future. They backed the empirical definition.
Some of the group’s observations were a bit fatuous; they noted that the CDC’s CFS group leads the world in the breadth and depth of its research. (How could they not with a budget five to ten times the size of any other group?). They also noted that the ‘the visibility and credibility of CDC as an institution has been an important partner in making CFS a visible illness’. Again, how could it not? Statements like this felt out of place in a critique.
They also recommended several changes; they felt the CDC should create international research and educational networks, engage with public health agencies to enhance surveillance and research and promote understanding of CFS and work to standardize gene expression testing. They recommended the CDC engage in intervention studies such as cognitive behavior therapy and graded exercise therapy.
Where’s the Plan? The panel’s largest complaint, and one that bore, if indirectly, on the CAA’s complaints, was the CDC’s lack of a long-term strategic plan. This suggested the program lacked some rather basic organizational elements, the lack of which could have contributed to the issues the CAA has brought up. Indeed it’s easy to see how an effort without time-based goals or performance measures could be left flat-footed when events go awry.
The Review Committee Punts Once – The review took place just days after the tumultuous CFSAC meeting in November when CAA President Kim McCleary called the CDC’s research program the ‘Research to Nowhere’, rated its accountability at ‘zero’, and called Dr. Reeves’ leadership ‘shameful’. Dr. Jason, one of the CFSAC members, wanted to make sure that that Kim McCleary’s report was in the packet of information that the CDC provided the reviewers and he persisted until he got a clear ‘yes’ from the CDC members that it would be.
But when it came to the big issue of the day – whether the program lacked basic levels of accountability and had squandered precious research funds and time – the Review Panel simply punted. No mention was made of the CAA’s concerns. As the Panel recommended that the CDC engage in more collaborative efforts, they didn’t mention that as the program funneled funds to Abt for no existing program at all, it was simultaneously cutting off the collaborative efforts it was engaged in at Dubbo and the University of Miami. Nor did it mention how little bang for the buck the CDC had apparently got for its money or the difficulty it’s apparently had getting its projects off the ground or the reduced productivity (reported by the CAA) over the past couple of years.
The committee had an easy ‘escape’ here; the lack of a strategic plan could have easily contributed to the problems the CAA noted but the Committee neglected to take this path and neglected this important issue altogether.
The Review Committee Punts Twice. The panel applauded the fact that the ‘The CDC intends to lead the development of clinical guidelines for the management of CFS’ but didn’t question whether they were providing doctors with the right information. The CFIDS Association of America believes the CDC physician education program is outdated and has created a new program.
Now we have two competing and very different provider programs. Instead of analyzing each, the Committee simply ignored the CAA’s program and endorsed the CDC’s one. They also agreed that the CDC should be the lead agency in educating physicians – a questionable assessment if they’re putting out a flawed product. Instead of critiquing the substance of the CDC’s provider package the panel simply focused on how effectively they were marketing it. (The CAA physician education program recently went on online. For an analysis of how it’s fared click here).
Dig Deeper! The CFIDS Association of America’s Physician Education Program
The Review Committee Punts A Third Time – The committee was given three questions, the most important of which was, “What goals should the program try to achieve in the next 3-5 years?” Given the program’s budgetary constraints and the number of options open to them, it’s important that when they choose a focus they choose wisely.
Yet the Committee refused to answer this question, stating they would review the program in the context of the program’s stated goals rather than in the context of what the field needs. That is, they didn’t address whether the program had the right goals, they simply addressed how effective the program was in delivering on the goals they had.
The panel could have taken a broad look at the CFS research field and graded the CDC in how well it was accomplishing its major goals; finding biomarkers, elucidating subsets, determining cause, developing treatment options, etc. “Why aren’t we studying biomarkers?” Kim McCleary, November 2008 CFSAC Meeting That would have identified any major holes in the program’s focus and could have identified whether the CDC is missing any opportunities (repeat exercise studies?). It also would have demonstrated how large the needs of the CFS community are (and given the reviewers the opportunity to note how poorly funded the program presently is).
The panel noted the controversy surrounding the Empirical Definition and then simply endorsed it. With the CDC looking at one type of patient and other researchers looking at another, however, the definition has the potential to balkanize the ME/CFS research field. “Particularly with the overlay of the empiric definition ….we don’t know what we’re looking at anymore. You can’t compare what the CDC is doing with what..(other) investigators are doing because they are using entirely different definitions of CFS” Kim McCleary CFSAC Meeting Nov, 2008 If the research community doesn’t embrace the definition then not only it but years of CDC studies run the risk of being labeled as mere curiosities – a potential waste far outpacing the CAA’s present concerns. If the definition leads the field in an incorrect direction the potential for damage is huge. Given the importance of a new definition it was incumbent on the CDC to engage the research community in its development but they essentially went into smoke-filled backroom and emerged with new and very different idea of ME/CFS.
One could make the case that it was too early to come up with a new definition; that the Reeves team should have focused on finding biomarkers for subsets and then created new definitions around them. . In fact one of Kim McCleary’s complaints – which was echoed by Dr. Glaser – concerned the lack of biomarker work done at the CDC. For all their good work the CDC group has a reputation for being something of a ‘group apart’ – a problem that the new definition has only exacerbated.
None of these issues, however, were raised by the panel.
Conclusion
Perhaps the review process – quick in and quick out – lends itself to rather superficial reviews. At the CFSAC meeting Kim McCleary noted that improperly structured external reviews can lack depth and she pressed the CDC to give the reviewers full access to their staff..
Whatever the cause of this lackluster review the ME/CFS community could have hoped for more. The CDC’s CFS research program is not simply another research program in a thriving field; with the loss of the Cooperative Research Centers at the NIH seven years ago it has simply dwarfed all others in size.
Given the CDC’s reputation, the CFS program is the one that physicians and researchers around the world look to for answers. Just to give one small example; attempts to interest the state of Vermont in publishing a Manual on ME/CFS failed until the CDC changed some aspects of its website that helped to legitimize the disease. At that point the project went forward.
The CDC has played an enormous role in legitimizing this disease – no other organization has come close in this regard. Medical professionals across the United States took note when the head of the Centers for Disease Control stood up at a national press conference and said CFS is a legitimate disorder. Contrary to popular belief, the CDC has run quite open-ended program. It’s Pharmacogenomic’s studies were an attempt to create a more or less blank slate from which any of a number of research avenues could have emerged.
But the program faces major issues few of which the panel took on. The panel didn’t whitewash the CDC program. In particular, they came down hard on the lack of a long-term strategic plan and noted several other deficiencies, but they didn’t confront several of the major issues facing it.
Not doing so essentially left the CFIDS Association of America and the patient community out on a limb in two areas; whether the CAA’s recent critique of the research program was justified and whether the CDC’s physician education program was adequate. With the CAA’s scathing report in their folders, the panel could have used the rare opportunity they had to question CDC personnel in depth and produce their own analysis. . By not taking up the CAA’s issues, the panel essentially endorsed the CDC’s position and gave them a powerful tool to help them to ward off calls for change. If change is needed in this program, this report made it that much more difficult to achieve. The patient community deserved better.
Dig Deeper! The External Review