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CFSAC Public Comments

Wednesday 31 December 2008

CFIDS Association of AmericaHere’s an insight into the politics of ME/CFS research in the US. It’s testimony given by K. Kimberly McCleary to the Chronic Fatigue Syndrome Advisory Committee (CFSAC) meeting held on 28 and 29 October 2008. Ms Cleary is President & Chief Executive Officer of the CFIDS Association of America.

Details of the meeting are available here:

http://www.cfids.org/cfidslink/2008/110704.asp

If you find the text too daunting to read on a web page (there is a lot of it), you can download and print the transcript and read it at your leisure:

PDF

Testimony to the DHHS Chronic Fatigue Syndrome Advisory Committee (PDF, 24KB)

Anyway, here’s the text of Ms McCleary’s testimony along with the follow-up discussion:

From CFSAC Meeting Oct. 28, 2008 Public Comments

Kim M., President and CEO, CFIDS Association of America Accompanying Document: Testimony to the DHHS Chronic Fatigue Syndrome Advisory Committee

Good afternoon. Most of you know me. For 18 years I have served as the chief staff executive of the nation's largest and most active organization dedicated to conquering CFS, the CFIDS Association of America. I had hoped today to come to share with you ideas about strengthening public/private partnerships to advance CFS research and education based on successes for other complex health issues.

However, I feel I must spend my time before the committee today to inform you about a situation of deepening and widening concern to all of us at the CFIDS Association, including my colleague Dr. Suzanne Vernon, a former CDC staff scientist. I regret that this testimony is necessary because we have been here before in this very room to talk about the same thing.

And in spite of my calm demeanor, I am outraged that again we are forced to confront serious funding issues at CDC just as we were 10 years ago in April 1998. At that time, it was Bill Reeves who took the courageous step to provide evidence of funding irregularities in the CDC's CFS program. A year later, the Inspector General confirmed that $12 million was reported to Congress as CFS expenditures when the money was actually spent on other programs between 1995 and 1998. Now, unfortunately, it is Dr. Reeves at the center of these problems with the CFS program. The headlines on these Chronicles seem oddly familiar; only my hairstyle has changed.

Based on information that we have received directly from CDC officials-and I do have to thank Mike and Sara and Steve for the improved transparency over the last five months-and also available on public information sites, the "boom" of CDC research that occurred during the post "payback" years from 1999-2005 has eroded into what I believe is a "bust" of shameful scientific leadership, zero accountability, invisible outcomes, and millions and millions of dollars stuck in suspended animation, if not wasted. At least in 1998 science was being conducted that would aid discoveries in other diseases. This time, only government contractors seem to be benefiting from millions spent for which there are no worthwhile outcomes for American taxpayers or CFS patients.

Please allow me to share an analysis of the data we have compiled. I understand that you have received copies of this in your notebooks. This is the same information that I have in addition to some searching I have done on public websites.

You're all familiar with the infamous "Bridge to Nowhere." Let me introduce you to what I call the "Research to Nowhere."

In 2004, CDC began funding a new series of contracts with Abt Associates, a for-profit business and research consulting firm with gross revenues of $225 million. CDC's CFS research program has contracted with Abt every year since 1989, from what I've been able to find, with most contracts being sole source awards. On September 1, 2004 (29 days before the end of the fiscal year), CDC obligated $632,000 to pay Abt to "conduct field operations for follow-ups of persons with CFS, chronic unwellness and well [sic] that were identified during baseline surveillance" in Georgia, about which Dr. Reeves presented regular updates to this committee. These studies were designed to "measure the clinical course of CFS, evaluate changes in population morbidity and evaluate the economic impact of CFS."

Funds were again obligated to this same contract in August of 2005, August of 2006, early September 2007, and August 18, 2008, just a few weeks ago. The total allocated to this contract so far is more than $3 million, although only $1.5 million has been spent. That's less than the first two years' obligations alone. So $1.6 million directed to this contract have essentially been stuck in limbo since 2007, signaling a lack of strategic direction, accountability, and performance by both CDC management and the contractor. Information provided by Sarah Wiley indicates that CDC anticipates needing to spend more money on this contract, but they do not know how much more or over what time period the expenditures will continue.

You may recall that this study utilizes the "empiric" definition of CFS about which many of you raised concerns this morning and on other occasions out of concern that the empiric definition is broader than the 1994 definition. So far there have been just three papers published as a result of this study that has consumed $3.2 million of CDC's programmatic budget.

This is not the only Abt study that was funded in the same time period. On August 20, 2005, CDC entered into another task order with Abt to "assess logistics inherent in identifying, contacting, and enrolling subjects into a CFS registry." The first obligation was for $1.4 million. On August 2006 and September 2007, several additional obligations increased that amount to $2.2 million. These funds covered protocol development, development of a statement of work, submission of approvals staging focus groups, and further revising a statement of work and OMB package-paperwork. The OMB package was not even submitted until 2007 and was not approved until August 2008.

The information that we got from Steve Monroe this morning is that they've enrolled just one patient in the three years since funding began. Again, the CDC anticipates having to spend more money, while at the same time they've spent less than a million dollars of the money they already have, leaving another $1.1 million in limbo. And you've heard Dr. Reeves say on many occasions that he has no new money to do collaborations or other new projects.

The third project is the clinical study being conducted in collaboration with Emory University for which Dr. Monroe provided an update today. This also involves Abt. The Abt portion alone, begun on September 13, 2005 with an obligation of $1.2 million, continued with additional obligations in September 2007 and August 2008 for a combined total of $2.6 million. This sum has paid for Abt to provide logistical services to help enroll patients at the clinical research center. Emory has also been paid a total of $1.8 million. So combined funding for Emory GCRC and Abt is $4.48 million. $800,000 of the amount given to Abt has not been spent, and these funds don't even include the support that NIH provides through the GCRC facility itself.

This study, in contrast to what Dr. Monroe's slides said this morning, will only examine 30 CFS patients and 60 healthy controls, so that comes at a cost of $149,000 per CFS subject studied. I'm sure all of the investigators around the table would love to have $150,000 to work up their patients. The group at Emory is also a group that's under close investigation because the department chairman, Dr. Charles Nemeroff, has been under investigation by Sen. Grassley for accepting pharmaceutical company payments without disclosing them.

The reason that I provide the dates on which these obligations are made is because it shows a pattern of "use it or lose it" spending occurring in the very final weeks of each fiscal year. I think that underscores the fact that the strategic plan is lacking. It's an issue that you all articulated in May, and given the fact that CDC will have a peer review next week that is largely the basis by which they will determine further research endeavors and a strategic plan, I hope that you will choose to do as you did the last time-and I urge you to do so for the benefit of the patients who are here today and those who wish to be here but can't be here-that you send another vote of strong no-confidence in leadership of this program based on these spending irregularities, the waste of the funds that have been allocated to these projects that have not been spent, and the lack of productivity of the dollars that have been spent.

Thank you for indulging my ire this afternoon.

http://www.hhs.gov/advcomcfs/meetings/minutes/cfsac20081028min.html

Follow-up discussion re: Kim McCleary's comments about CDC's CFS research program- CFSAC Meeting Oct. 28, 2008

Dr. Jason: All of the patient testimony has been riveting, as it has in the past, but particularly the largest patient organization in the country has brought up some issues that have prompted some follow-up questions that I'd like to ask Kim. We have time before adjournment.

Dr. Parekh: The committee is absolutely free to discuss any issue that it would like to. It would be appropriate to call Kim back to the table in order to ask her questions. [Kim agreed to do so.]

Dr. Jason: The issue that concerned me the most is the issue of the CFIDS Association being threatened with allegations and some type of retribution. I'd be interested in hearing more about that, if that is what you're alleging.

Ms. McCleary: I wanted to make the committee aware of that, that wasn't really the focus of what I had hoped to bring to your attention. I don't think there's really any role for the advisory committee in that particular issue.

Dr. Hartz: How did your concerns with the CDC begin? Were there some things that you noticed that seemed to be not operating well? With the numbers and the areas that you looked at, it seems like there would have been motivating factors that got you to start looking at those.

Ms. McCleary: As you know or may have noticed, I come to every single one of these meetings. I think I've missed only one public meeting in 18 years. So, I have made quite a study of what's going on with each of the agencies, how the programs are unfolding, how the studies are moving forward, and I do my best to keep close documentations of materials that are provided in these types of forums.

I also served on the blue ribbon panel that CDC convened at the beginning of last year and was given some information at that point. Drs. Bateman, Klimas, Hanna, and I were all on that panel together. We made a series of recommendations and expressed some concerns at that point about the direction and the pace of the research program that did not seem to be in proportion to the resources that were being spent, although we weren't asked to comment specifically on the resources.

Also, the CDC program was without a home and in the process of the reorganization. There was quite a lot of discussion about the lab issues versus outside collaboration and external studies, so we were looking closely at that.

As a contractor, we were asked to do certain things with regard to provider education. I've been asked by you to provide an update on that, and I'll just give you some of the outcomes, but it was our feeling that we were missing a return on investment-that the way the research group asked us to conduct those education activities, we were really missing the boat as to where the bulk of the need was among the provider audience.

We began registering our concerns over a year ago and as Dr. Miller pointed out, we've met on many occasions in person in Sen. [Jack] Reed's office and by telephone. We've gone over our concerns, and many of the issues that I raised this afternoon have been raised directly with CDC, so I don't come at them from behind. It's been a building issue that we tried to rectify internally with the research program first, and then with the leadership. Now we just felt that this was an issue that the advisory committee could help focus some attention on to try to get things back on track, because the need for this research program is obviously great.

The research group at CDC has the most money in all the world to study this illness. That's a sad fact in and of itself, that $5 million is the most money in the world being spent by one group of people. I think it was really the trip to Japan that Suzanne and I made in April where they have 20 percent of the budget, 10 times the number of people, and the science is amazing. It's not a lack of resources at CDC, it's a lack of leadership, and that's really what it boils down to. Hearing the concerns of this committee over the last year has reinforced that. We felt that it was important to bring that discussion to all of you this afternoon.

Dr. Klimas: I would hate to see this evaluation move into a crisis phase that would result in losing the CDC program. That would be just devastating to our field. The program represents half of research being done in the whole country in terms of expenditures. I hear what you're telling us, but God forbid the end result be that the program be dismantled. First, the basic science going on in the research group is just phenomenal. The laboratory strength is really good and they have the potential to be leading the whole world in the advances in this area. Please don't let the ball start rolling down the hill in a way that results in the program being dismantled. That would be a disaster.

Dr. Miller: First of all, this is my second meeting, and we all recognize the incredible value of this group and of the public attending these meetings and how important they are. I can assure you that we have no intention of dismantling this program. Everything we have is driven by resources and how those resources are spent. We have tried to be as transparent as possible. We have answered, I think, every question that CFIDS has asked of us. We've met with them. We clearly respect the work that they've done over the years and will continue to do. We really want to continue to be the team player that you expect.

While that obviously is not where people think it needs to be right now, I think we are doing good science. We have no scientific journals-at least that I'm aware of-that have dispelled the science that we have done. We all want to do more and we'd love to do it faster. I can't tell you that that's going to be solved tomorrow, but I can tell you that we are listening and we are trying and we are as much a team player with you as we can be right now.

Dr. Hartz: Do you feel that the CFIDS criticisms are valid; that there are some concerns about how this program is being administered?

Dr. Miller: We've talked with Kim before and we're aware of her concerns and she knows that we're aware of her concerns, so nobody's an enemy here. We all want the same goal. But the way that the money is handled with obligations and actual spending, etc., very often, as many of you know, we don't get our budgets until these few weeks before the end of the year. We have early cutoffs and things happen. I can't explain all of this at this meeting. We'd have to have other people to do that, but Sarah and I both have been very concerned about being open and transparent with every penny that we can show, and we've tried to do that as best we can.

While it may not be as clear as it needs to be, I wish I could be the one to explain where every one of those pennies goes. I'm not the one to do that; that's not my role. But I can tell you that we are trying to be as good stewards of the funds as we can. That the studies that we're doing right now with the Emory group, we've already had 400 people who have gone through a certain part of this. We have some 30 patients involved, but I'm not sure how all of that works. Remember, that's down at the program level. If you have further questions and you need further clarifications, Sarah and I are more than willing to accept those. We have nothing to hide.

Dr. Snell: As somebody who works on a shoe string budget, when I start to look at some of these numbers, I was somewhat appalled. Not to denigrate the science, but it just does not seem to be the best use of the funds. The thing that we asked for at a couple of previous meetings was for the CDC to consider more collaboration with outside entities. We meant people who work a lot cheaper. It would seem that there are people out there with great ideas who would love to work with the CDC for much less money.

I think the CDC needs to use the same mechanisms that are generally found throughout science--putting things forward to peer review. I always worry about these big companies that set up purely to do work for other people. Most of the money is obviously gone already, but I think that in the future, if we look at different methods for funding this sort of research in the CDC, it might be more inclined to consult outside itself rather than set a study up and contract somebody to do the work. Even competitive bids-if you're going to have a house built, you bring a couple of builders in and at least get two costs from them.

Dr. Hanna: Suzanne came to our neuroimmune mechanisms while she was still at the CDC. She and I both hoped that we could collaborate and perhaps put out a joint program announcement so that we could take advantage of all the wonderful scientists who are out their doing all this great NIH research. Today you just heard a little bit of it. If they could only have bid on analyzing this data and so on, I think you get a bigger bang for the buck. We shouldn't be awarding money like this without peer review. I don't think that that's for Dr. Miller or anybody to address. This is something that has happened and I think going forward they know exactly what they need to do. They don't want to shut this down. They have a great database, they've got a great program.

Dr. Snell: One thing I would like to see is Abt being held accountable for money that they've spent-to make sure that those are true costs and we're not seeing CEOs with huge payments.

Dr. Hanna: That's why it's important to have them present proposals the way we do with grants.

Dr. Jason: Is this testimony that Kim has delivered to us going to be made available to the reviewers who are going to the CDC next week? Is the review that comes from them going to be made available to us at some time so that we can see what they had to say? And finally, Anand, I'm wondering are there things that we as a committee can appropriately do in this issue that don't run into some kind of conflict with our bylaws? Are there some action steps one way or the other regarding these issues?

Dr. Miller: I think that the documents that were presented here are public documents now. They would be available. Our CFSAC chairman is slated to be a part of the peer review group, so if the chairman wanted to bring this document to committee, I'm sure he could. As for the report that comes from the peer review, yes, that's a public document also. That group writes that report. I don't know what the time frame is, but it should be written fairly soon after the two and a half day session.

Ms. Wiley: Yes, we do plan to make the report available publicly and we hope to do it soon. The report is to be written by the panel members and we can't expect them to turn that around in a week, so I can't give a specific time frame. It will need to be made in a timely manner, because we need to act upon it very soon. The clock is ticking on the Federal fiscal year and if we're going to be making changes to the program, those need to be initiated very soon. As far as recommendations from CFSAC, we would very much appreciate those. This is definitely a time for input and we are at a place in the CDC research program where we need your input here. Next week we're seeking the input of the peer review and following that, we'll be meeting as an internal leadership team to make some real decisions about FY '09 programming.

Dr. Miller: Sarah and I are both sensitive to the past issues of slow response or no response. We're sensitive about responding as quickly and as fairly as we can.

Dr. Parekh: In answer to your questions, Dr. Jason, the function of this group is providing advice and recommendations to the Secretary, and I think that CDC would continue to welcome this group's recommendations on these issues.

Dr. Jason: I could see a number of potential motions. One simple one could be that CFSAC could recommend to CDC to make this particular report available to those site visitors so that at least they can follow up with some of these questions when they are at that meeting next week.

Dr. Miller: There is an accusation in the report that I was not aware of, Kim. I did not know that there had been a threat of any kind from anybody at CDC, so that's an important document that we have in here now. If that's the case, we need to know about that.

Dr. Hanna: Maybe it doesn't have to be Kim's report that's made public, but rather the data on which she based her report, because I know that lots of people have been examining the NIH funding and the grants process. I've been going through this for years. Different organizations come to different conclusions. I was able to see that what I've been reporting over the years is dead right-NIH spends a lot more money on CFS research than what shows up in the NIH budget for various reasons. I don't think money is the issue, and I think when we're talking numbers, especially where accusations are involved, we shouldn't be presenting specific reports from specific organizations. But if you wanted to make the data available to your committee, then that would be another story.

Dr. Snell: This review is to be helpful to CDC so they can see areas where they can do things better. It would seem very obvious to me that one of the things that you would ask the reviewers to look at is, are we spending the money in the best way appropriate? I would hope that we wouldn't need to make that recommendation forcefully at all.

Ms. Wiley: I don't recall how the questions were worded that Dr. Monroe presented to you this morning as far as the charge to the committee, but one of them is about resources reflecting priorities. They will be getting budget information.

Dr. Miller: The chair will be free to delve into whatever issues the reviewers wish. It's up to the committee and we have nothing to do to control that.

Dr. Bateman: Since Kim represents a very well informed voice on behalf of patients and the public, I would like to ask you, Kim, what you would like to see the CDC do with their resources?

Kim: I'd echo what Nancy said, that the loss of this program would be devastating because it represents at least half of the Federal investment in science and education on CFS. That's limited to begin with, and we don't want to take that in half.

I do believe strongly that there needs to be a lot more oversight by leadership, and strategic vision that goes into how one dollar is spent or how $5 million dollars are spent, because the dollars are so precious. There are so few of them. We have to make them stretch further than if we were talking about the HIV budget or bioterrorism.

There are tremendous opportunities for CDC to be much more collaborative in terms of the science that it does. It has in some ways gone beyond the mission of a public health agency and tried to address some of the issues of the etiology and biomarker discovery that I think CDC has capacity to do, but I'm not sure that sending millions of dollars out to a contractor to set up studies is the best use taxpayer dollars.

I'm concerned about the peer review next week for reasons that were underscored this morning. The last peer review took place 10 years ago, so I'm not sure whether you're focusing on the past 10 years since the last peer review or a certain chunk of time since then. For five people to come in for two days and look at all of that data, it might be misleading. It's hard to get to that when you're faced with mounds of paper and trying to do an analysis. I've talked with Sarah about this-how the presentations are made, who the members of the peer review have access to, how freely the members of the research group can act with them-these are all important dynamics and we certainly saw that on the blue ribbon panel meetings. There was a bit of distance and we didn't get to question people as closely as possible.

I think there is tremendous passion among some of the people in the CDC research group. It's been diffused because there has been no strategic direction coming from the top over the past several years. That's evidenced by the lack of outcomes and the way that the dollars have gone out and not produced much in terms of product for this committee or the patient community or us as a nation.

There were a couple of things said this morning with respect to the GCRC study that I just want to clear up, and that may demonstrate these little subtleties. Dr. Monroe had a slide that showed that 400 patients had been evaluated. Those are patients that came out of the Georgia surveillance study, not new patients brought into the Emory site to be screened. They're coming out of another study, so you're sort of double counting the effort under two columns.

When it all comes out, there are only 30 patients studied and 60 controls. Mostly what's going on in the GCRC study is to look at CFS patients' response to the psychosocial stressor-a speaking test. Anybody who gave public testimony today can tell you what happens to them when they come up to a microphone and they have to give a talk. We know what happens. There have been studies. Eleanor's funded studies on that same thing. I don't know why we're doing that over. The fact that it's $4 million and that it's been spent over these years is one point, but looking at what the study's trying to accomplish is another mind boggling level. Why aren't we studying biomarkers? They took out a lot of the biology.

Dr. Bateman: I would like to know what you'd like to see done.

Kim: We've stretched epidemiology perhaps past where it needs to go because now we're broadening the definition, and other people feel subgroups are essential. The biomarkers, the treatment, the education-that' s what we all know we need. We need a diagnostic test and effective treatments, and CDC has a role in that. CDC needs to do what CDC does best-not contract out a bunch of studies to contractors who are going to make more money at it than the academics would. There needs be some extramural piece of the program, there needs to be a lab effort that's maintained, and they need to be able to merge the unique ability they have to do things like longitudinal studies that only CDC can do.

Dr. Hartz: Would you change the current longitudinal studies as described?

Kim: The longitudinal study has been held up, as I understand, because it's supposed to have T0 , T1, T2, and now that timeline has been stretched out, and many of those patients are not able to be contacted. The way that things have unfolded, I don't know what we're going to get out of the way that things have been executed. The design was probably sound, and when it started off it was probably looking at the right things, but the way that it has been eroded over the years, it may tell nothing at the end of it. Particularly with the overlay of the empiric definition being the driving force of that study, we don't know what we're looking at anymore. You can't compare what the CDC is doing with what the NIH-funded investigators are doing because they're using entirely different definitions of CFS.

Dr. Miller: So the longitudinal studies are OK if we had a single definition?

Kim: Well yeah, what you measure and how often you measure it and how long you measure it. As Nancy said, we don't know what the cancer rates are in this community and CDC has had a program for 20 years. We ought to know that by now.

Dr. Glaser: I've been sitting here listening to all of this, and it's a really good interaction because it puts a lot of issues on the table that should have been on the table and really discussed seriously. Kim is right. This GCRC study is a good opportunity to get three days with detailed measures including some good immunology and a significant effort to determine etiology. It's the obvious thing to me that I would do if I were writing that study, and it wasn't there. I'm going to repeat this again: until we deal with a biomarker or markers, diagnostics, and etiology, everything flows from that. A lot of the social and legal issues flow from those two areas of research that should be supported. That's what individual PIs out there in the world and the CDC ought to be focusing on.

Dr. Klimas: Four years ago I was funded by the DOD to do study comparing Gulf War Syndrome compared CFS in collaboration with the CDC. In this study we collected samples from 105 people. We put them through an exercise stressor and we were trying to map out the mediators of relapse. The total budget was $450,000. We collected all the samples and did all of the expensive immunology. The CDC could not finish its portion of this study-the gene expression analysis for Gulf War Syndrome.

I was struck when I looked at that GCRC budget because they're basically doing the same thing, and they have $2 million this year. I have in the freezer everything completed except for the genomics part of my study. I have an appointment with the genomics team at the University of Miami next week and I think that they're going to help me out. I don't want to go back and collaborate with CDC because it's the second time I had the plug pulled on this study in the last year. It's embarrassing and it's also a missed opportunity. There's something wrong. I understand that budgets and priorities shift, but to not run the CFS samples seemed rather odd to me. I find that to be the most disturbing of the symptoms of what is happening at CDC.

Dr. Jason: I just want to thank you, Anand, for being extremely flexible with the meeting structure so that we were able to really pursue lines of questioning and deliberation that made today probably about the most interesting day that I've spent at one of these meetings. At the same time, I'm kind of struck by the issue that there's this incredible opportunity next week to do a peer review of a very important organization. Kim has said that she spent 18 years coming to these meetings and probably spent hundreds of hours coming up with her report.

We've had several years to think about some of the issues. There's so much that we have learned and so much that has occurred today, I'm just kind of nervous that when I asked Mike if this committee will have access to Kim's report, he replied that it's in the public record. There are thousands of things that are in the public record. There are lots of documents, and the peer review has a very short period of time, so again, I'm going to ask you, is something as important as that report going to be made available to the review committee?

Dr. Miller: Remember I said that the chair of this committee is going to be part of that board, so he should be able to take that with him. The answer to your question is yes, I see no reason why this should not be a part of that peer review. It's public, it's available, it's very germane to what's going to be discussed, and it should be there. They're going to have the same numbers that Kim had to work with.

Ms. Wiley: We are putting together the final packets of information that will be provided to the panelists before they come to the meeting. I see no reason not to include everything that has come from this meeting. It's germane, it's current, and we very much want your input. You have a time in your schedule to make formal recommendations. We very loudly and very clearly heard what you don't think we should do. We would really like to hear what you do think we should do. I've been taking notes. Let us know where you think our research priorities should lie. We will ask the same question next week of the committee, and it will then be up to the management and leadership team at CDC to make the final decisions of what we'll be doing in FY '09.

To address the question of timeframe, Dr. Monroe as the division director is the one who is actually directing the peer review effort. I don't want to speak for him, but I believe that I am correct in saying that what we hope to do is to set the strategic direction for the next five years. While it is important to talk about what has gone on to date, and what's currently going on so we'll know what resources and data are available to the CDC program, I hope that we will not dwell on what has happened in the past, but rather be asking the committee next week for input into where we should go now.

Dr. Parekh: This has been a great day of deliberation. I would like to thank CFSAC members as well as members of the public as well as all of our invited guests.

http://www.hhs.gov/advcomcfs/meetings/minutes/cfsac20081028min.html

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