“I was sitting there yesterday (during the CDC presentation) feeling like my head was going to blow off my shoulders”
The CFID’s Association of America has been leading the way on the CDC review. Kim McCleary sits through every CFSAC meeting – not an easy task in that often mostly empty room – and takes notes. It was the contrast between what Dr. Reeves said the program was going to do and what it actually did that apparently triggered their investigation. Projects that were supposed to start didn’t, others that started seemed to drag on and on and they seemed to have lost their zest. The CAA began taking a deeper look. When the ten year review came up they reported their findings. They called for more accountability, for a strategic plan with specific goals, for more creative research, for new leadership and a new home for the program – basically they called for a complete overhaul of the program.
The Plan – They didn’t get any of it. It was as if their complaints had fallen on deaf ears. Despite all the calls for specifics Dr. Reeves gave a talk that was big on the past but which gave little indication that the CDC had tightened up its ship. I was able to talk to Kim during a break. It seemed to me that Dr. Reeves had spent most his time talking about either the past or how the plan had come about. He didn’t seem to address the future much. I asked her about that and she agreed.
“Dr. Reeves spent all his time on past history and then nobody realized that we’re supposed to be thinking about 2014. Where’s that in this plan?“
“That Vision Thing” One of the CFID’s Association’s chief concerns – perhaps their major concern – is what they believe has been the program’s lack of vision and a paucity of innovative research. (The latest publication from the group examined just two common immune factors). I asked her if present plan give her any hope in this area? It didn’t.
“The fMRI stuff they’re doing has been done by Deluca, Lange and others. Now they want to study CBT- well, that’s been studied to death by NIH funded investigators and by investigators in the UK. We don’t need more data on that. It’s basically a kitchen sink plan with a few popular accessories.”
The CFID’s Association believes there are lots of good ideas out there but few of them are making it to the CDC’s research team. It’s not that the research the CDC is doing is necessarily ‘bad’ but what the group has missed out on by making the choices it has. The cost of doing another sleep study, a two-factor inflammation study, another CBT study , a metabolic syndrome study, is not participating in other research avenues. Kim noted that
“Many research teams come to them with ideas for collaboration and they’re told “It’s a great project but we don’t have the money to do that”….but it’s all about opportunity costs. If you’ve got four or five million dollars and you’re going to study unwellness in Bibb County, Georgia and you’re going to collaborate with a psychiatry group at Emory and with Peter White on implementing the NICE guidelines in the United States then you can’t do any other things because you’ve spent all your money on those things. “
Collaboration? Another frequently cited problem during the comment session and by the CFSAC panel itself was a lack of collaboration. The CFSAC panel bluntly took Dr. Reeves to task for treating the rest of the research community as junior partners or almost underlings.
Now the CDC was stating that three international workshops would take place over the next year. What was the CAA’s take on this development? Did it suggest that the CDC that this rather closed program was finally opening up? Kim McCleary was not holding her breath noting once again that the plan lacked specifics – there weren’t any with regard to workshop membership – which left the program more than enough wiggle room to continue acting as it had in the past.
“They didn’t describe how they are going to pick participants or the agenda. We’ll see if they control the participant list as they have for the past five years. Someone said yesterday that your (the CDC’s) “idea of partnership seems to be more like subcontracting than it is getting real engagement and trying to get people’s ideas in on the front end.”
Dr Reeves had originally promised an international workshop would take place in 2008 but here it was the middle of 2009 – evidence of another project that had gone off the rails. Poor planning had been a key theme of the CAA’s report.
Fiscal Accountability? After all the CFIDS Association’s documentation of fiscal mismanagement the plan also lacked basic aspects of fiscal accountability. The CFSAC panel pointedly asked the CDC personnel how they expected to achieve the results of their plan given the meager funding the program now receives. None of the staffers had an answer for that. This kind of oversight, coming on the tail-end of the CFIDS Association investigation that found evidence of poor accountability came as a bit of shock.
“They didn’t even have a sense of how much it would cost to do this. That was another kind of astounding thing”
This made me wonder if the CDC had ever really taken note of the CFIDS Association’s assertions of fiscal problems. They CAA formally asked the CDC to provide semi-annual reviews of their expenditures. What was their response?
“They have said that they will continue to be transparent but they weren’t specific about when. They should at least provide that information in the agency’s annual report to Congress. They’ve been responsive to requests for data, but nobody’s doing any serious analysis. The Emory GCRC study is now, I believe, over four million dollars (through 2008) for 60 patients and 30 controls to analyze response to a public speaking stress test. That’s about $50,000 per subject, or $150,000 per CFS patient studied.”
I noted that makes it probably the most expensive research project ever…..Kim responded
“Exactly and they can account for every penny of it but nobody seems to care whether that’s the right thing to spend that money on. That’s the kind of accountability I’m looking for – not just a pretty spreadsheet where all the totals add up. “
You went to the leadership. You had congressional support. Was there any recognition that they’ve kind of fumbled away a lot of money?
“No – no recognition”
How about the idea that they are pursuing less than creative research avenues?
“No, no recognition . I mean that was what this whole strategic planning process was about. I’m going to go back and look at the latest research planning update – I think it was from 2006. I’ll bet most of it is consistent with this plan, which was supposed to be forward thinking – looking ahead five years. I don’t see anything in here that’s particularly innovative.”
Willful Disregard? The CAA didn’t jump on the CDC out of the blue. They got access to CDC records, studied them and over the last year or so have tried to work out their differences in private. It was only after that didn’t work that they went public. They’ve richly documented their assertions. They’re known for their objectivity. If anything the patient community thinks they’re are too conservative. Given their history and the amount of work they did their lack of traction at the agency is troubling. It suggests that the program’s success is simply not a priority at the agency.
CFS Still Odd Man Out at the CDC - I talked to the Director of the Rickettsial Branch, Dr. Monroe and the CDC’s liason to the CFSAC, Sarah Wiley, at the break. I asked if it wasn’t a bit much to ask their researchers to cover so much ground (find subsets, biomarkers, redefine the disease, provide treatment trials, determine prevalence, educate physicians and public health officials, etc. ) on 25% less money than they had 10 years ago.
They admitted the difficulties but said their hands were tied – it was Congress, after all, that decided how much they could spend on chronic fatigue syndrome. But surely Congress asked for the CDC’s recommendations on spending? “ Yes” . Had they ever recommended increasing spending over the past ten years. “No”. Dr. Monroe implied that if they had it would have been cut at higher levels anyway.
To the CDC’s credit they’ve funded studies that have very powerfully shown the high societal costs this disorder has. To their discredit they’ve completely ignored the implications of those studies. It bears repeating – the CDC is spending 25% less on chronic fatigue syndrome than it did ten years ago.
It could very well be that the CDC just doesn’t want to participate in the hassle of finding new leadership, moving the program to a better place in the agency and re-organizing it. If they’re allowing its budget to drop so significantly even as they’re increasing their prevalence figures four-fold why should we think they have any interest in listening to anyone’s concerns about the program? Over the past year Kim has interacted with CDC officials more than anyone else. I wondered whether the CDC just wasn’t really concerned about how effective this program is. She stated
“I don’t know how to make it any more clear to them that they should be concerned. I sat with Sarah Wiley and Mike Miller and Steve Monroe in Senator’s Reid’s office a year ago”.
But then something happened – the November External Peer Review….
“ I think they were ready to recognize the need to change before the November peer review. That clearly became their inoculation against any criticism of the program. Reeves’ comments yesterday about Peter White being a favorite “sparring partner” should have been enough to indicate the conflict of interest he had in participating as 1 of four people on the peer review.”
A Defining Moment -The Peer Review was produced by four invited researchers who spent three days at the CDC and then shortly thereafter produced a report that addressed none of the CFID’s Association’s claims. It hailed the CDC’s accomplishments, proposed that they build a international research network, and proposed that they lead the field with regard to treatment guidelines and physician education. They also backed the Empirical Definition.
Not long after this Dr. Reeves faced a barrage of complaints about his lack of collaboration, both the CFSAC and IACFS/ME called for the ditching of the Empirical definition and both asserted that new leadership was needed at the CDC. At the same time the external review panel was proposing the CDC lead the field in educating physicians the CFIDS Association released a physician education program on Medscape (which Dr. Reeves refused to collaborate on) which enrolled more physicians in a couple of months than the moribund CDC provider education program had in years.
Kryptonite - In short the report turned out to be out of touch with virtually every other assessment of the CDC’s program yet it’s become the fulcrum CDC officials have used to turn away every negative assessment of the program. It’s basically been kryptonite to the CFID’s Association’s and other attempts to induce major reforms at the CDC. It was immediately posted to their website and CDC officials bring it up again and again. At the latest meeting Dr. Reeves hailed it frequently and Dr. Monroe exclaimed what an excellent report it was. The CDC’s focus on it has naturally left Kim McCleary more than a little chagrined.
“A friend sent me an e-mail last night after watching the videocast suggesting that we create a new drinking game. Every time somebody from CDC mentions the 2008 external peer review as a reason why they can do whatever they want to do, we take a drink. I’d have been drunk before lunch time whether I drank scotch or vanilla extract.”
The Next Step. Patients who feel change is needed got a boost in the arm from the IACFS/ME’s and the CFSAC’s recommendations. The CDC seems resolved not to make major changes in the CFS program but the review period is not over and one wonders how they can not respond to the increasing roar for change.
The (real) Draft Five Year Strategic Plan has been released on the CDC’s site and they’re taking comments until June 30th. We have a new Secretary of the Dept of Health and Human Services (Gov. Sibelius) and new leadership at the CDC itself. Using their virtual lobby day technology the CAA is providing patients the opportunity to make their views known to the CDC and to request Secretary Sibelius to implement the CFSAC panel’s recommendation for new leadership at the CDC. The process continues…