Kim McCleary: Open letter to CFS community

[Cort]

What has the CFIDS Association done?

I know its hard (even impossible maybe) to see differences in our day to day lives but we started out from a very low point and the CFIDS Association is a small organization - the federal bureacracy is huge. We're not diabetes, remember, we're the disease with the crummy name and little funding. The little national organization operating (so I've been told) out of its sad sack suite of offices in Charlotte is advocating for a disease that most of the federal bureacracy wants nothing to do with.

Nevertheless they've had substantial accomplishments. I honestly don't know this doesn't seem to filter down to the patients more.

• Got the CDC to mount its first ever multimedia campaign on a behalf of a disease. This was a multi-year effort with print, TV and radio spots that reached millions of people. In 2007 there was more than a story a day on CFS - they were almost all good. The campaign also included a Faces of CFS exhibit that millions of people saw in just one year. The CFIDS Association paid for none of this - it was all financed by the federal govt.
  
• Got the CDC to engage in Provider education effort that included making exhibits at numerous scientific conferences, creating a physician toolkit and a Train the Trainer program utilizing some of our top physicians and researchers.
  
• Created its own physician education program on Medscape that educated 35,000 physicians in its first year and potentially impacted 100's of thousands of CFS patients.
  
• Funded research into repeat exercise dysfuntion/metabolic dysfunction, endogenous retroviruses, brain mitochondrial problems, nitric oxide and vascular dysfunction, gastrointestinal problems, muscle receptor problems and EBV. These are some of the hottest topics in the field. The repeat exercise studies are changing the way our research field functions - they would have gone nowhere without the CAA funding.
  
• Created the Banbury Conference in which 35 of our top researchers met for 3 days to brainstorm about CFS
  
• Fought off attempts to dissolve the CFSAC (were central in creating the CFSAC)
  
• Documented enormous financial problems at the CDC and poor productivity, called for new leadership, for the program to be moved elsewhere and slammed the CDC for venturing into CBT and using the Empirical Definition
  
• Is currently developing an International CFS Research Network that will result in researchers sharing resources, samples and data and should speed up research significantly.

That's off the top of my head. They're not a big organization; they're not particularly well supported and they're doing alot with what little they have. Thats my impression.

 

[bjsmith]

I posted this on Facebook; thought it might be appropriate here as well.

Over the last 3 years, I have had the opportunity to work with Kim, in our common fight to solve CFS. I have never met someone as hard-working, qualified, devoted, and effective to lead this battle. My statements regarding Kim are not the result of misguided loyalty or allegiance. As a Board member, I am obligated to thoroughly examine and scrutinize Kim's performance -- I am firm in my stance that there is no one who is more competent and experienced to better lead the CFIDS Association, as well as the CFS population's collective cause.

As a patient that struggles daily with this disease, I would not feel comfortable with anyone else leading this effort.

 

[fresh_eyes]

Welcome, bjsmith. I'm so glad to have CAA representatives on here. Hopefully it will lead to fruitful dialogue.

 

[Advocate]

As a patient that struggles daily with this disease...

Hi bjsmith,

Welcome!

 

[bjsmith]

Thanks for the welcome. For what it's worth, I've been reading the different forums for awhile, listening to the patient community. After all, I am a patient first and foremost. Nearly half of my life has been stolen by this disease, since I was a 15 year old, "All-American" kid, who excelled in academics and athletics.

As corny and altruistic as it sounds, the reason I fight everyday to solve CFS is because I don't want another 15 year old to go through what I have experienced over the past 14+ years.

 

[bjsmith]

Thank you for giving us the benefit of your opinion, bjsmith. Of course, it needs to be pointed out that since you are a member of the CFIDS Association Board, you would hardly make a public statement saying something bad about the CAA or your President and CEO.

That's a fair enough question, but please don't jump to conclusions. As I previously stated:

"My statements regarding Kim are not the result of misguided loyalty or allegiance. As a Board member, I am obligated to thoroughly examine and scrutinize Kim's performance -- I am firm in my stance that there is no one who is more competent and experienced to better lead the CFIDS Association, as well as the CFS population's collective cause."

If I did have an issue with the CAA, or its leadership, I would be the first to speak up. Just because I volunteer for an organization, does not mean that I a do not think/act independently, or that I do not have an opinion. I experience this nightmare disease day after day -- I can assure you that if I noticed anything that was negatively impacting our collective cause to solve CFS, I would no longer be a part of it.

If you knew me personally, you might have an idea of what an outspoken and determined individual I am. It would not be possible for me to work with an organization that I did not wholeheartedly believe in. I'm a fighter by nature, and I guess I'm just not built that way...

While some are quick to point out anything and everything that the CAA and company do wrong, let me remind you of a few things off of the top of my head:

The CAA played a pivotal role in the establishment of the landmark ruling SSR 99-2p, which allows those with CFS easier and better access to their rightful SS benefits. The CAA helped to expose the $13 million misappropriations scandal by the CDC a decade ago, which lead to an influx of funding for CFS research. The CAA, and specifically Kim McCleary, was the first to uncover and speak out about the gross misuse of CFS funds at the CDC during her testimony before the CFSAC in October 2008:

http://www.youtube.com/watch?v=bRaXeGWtcQI

http://www.youtube.com/watch?v=nnblupMPG8w

http://www.youtube.com/watch?v=5a4OlYDn0iY

http://www.youtube.com/watch?v=QSURZZUBsHk

And trust me, this was not easy to get on video -- it was before they began video-casting the CFSAC meetings, so I captured all the video with my personal camcorder after being told to "shut it down" three times by the powers that be. When I ignored them, they threatened to call Capital Police, as well as confiscate the video I had.

The CAA has funded research for years, and has built a more robust research program over the past 2 years. In 2007, Dr. Suzanne Vernon left a stable government position at the CDC, with guaranteed pension benefits, as well as a hefty salary, to join the CAA. Suzanne recognized that she could better serve those with CFS by joining the leading edge of a movement dedicated to making positive change. Also, the CAA has never funded research based on the empiric definition, nor has any education effort by the Association been based on the empiric definition.

http://www.cfids.org/profresources/grants-guidelines.asp
http://www.cfids.org/cfidslink/2009/070108.asp

So to make a long answer short, no I do not believe I would have any problem "rocking the boat" if I noticed something wrong. Like I said, first and foremost, I am a patient, and want nothing more than to take back my life that has been hijacked for nearly 15 years, since I was a high school freshman. I believe the CFIDS Association, as well as Kim McCleary and Suzanne Vernon, have helped to propel this charge in many ways, and will continue to make headway in advancing our common cause. Now more than ever, we must unite to solve CFS.

 

[hvs]

nor has any education effort by the Association been based on the empiric definition.

This might be true in the details, but not in spirit; the CAA did formerly refer people for more information on CFS to a CDC website that towed the CDC line on definition, recommended exercise, etc.

bjsmith, you have every right to defend the CAA to the gills. A very reasonable argument can be made for doing so.

But please, please, please, police the CAA's reaction to what I expect will be a failed federal replication attempt. If the feds fail to replicate because of a methodology that employed many Wichita/Georgia people, the CAA must NAIL THEM. No passivity, no trying maintain some kind of appearance in front of federal agencies.

Frankly, my concern over the CAA's performance since the Science paper is utterly unchanged by the fact that Kim McC and other CAA members are ill or have ill family members. Tell me about it. I care about their performance at crafting and controlling the message and influencing the government. (And they're completely negligent if they are not supporting the WPI financially.) Don't plead that you really care. Apologize for dropping the ball and bring you A-game. Now.

 

[fresh_eyes]

...the reason I fight everyday to solve CFS is because I don't want another 15 year old to go through what I have experienced over the past 14+ years.

Amen, brother/sister! Not corny at all.

I do hope you and jspotila will stick around. I think you'll see that people have some valid criticisms of the CAA, even if, as many point out, they/you have done much good work. I think the most fruitful direction for this conversation to go is toward how the CAA needs to change to better meet the community's needs, and how those changes might be implemented.

 

[jspotila]

This might be true in the details, but not in spirit; the CAA did formerly refer people for more information on CFS to a CDC website that towed the CDC line on definition, recommended exercise, etc.

I think you are referring to the websites that are part of the CDC funded public awareness campaign. The CFIDS Association has never funded research using the empiric definition, nor has our education activities. In fact, the Association has voiced strong opposition to CDC continuing to use the flawed and overly broad empiric definition. See http://www.cfids.org/cfidslink/2009/070108.asp.

But please, please, please, police the CAA's reaction to what I expect will be a failed federal replication attempt. If the feds fail to replicate because of a methodology that employed many Wichita/Georgia people, the CAA must NAIL THEM. No passivity, no trying maintain some kind of appearance in front of federal agencies.

Yes, we are very concerned about replication study failure due to patient selection or other methodology issues. Dr. Daniel Peterson and Dr. John Coffin addressed this issue at the CFSAC meeting on October 29. (transcript at http://aboutmecfs.org/Rsrch/XMRVQA_CFSAC.aspx.) Dr. Suzanne Vernon is a member of the new federal working group on XMRV, CFS and blood safety issues: http://www.cfids.org/cfidslink/2009/120203.asp

Frankly, my concern over the CAA's performance since the Science paper is utterly unchanged by the fact that Kim McC and other CAA members are ill or have ill family members. Tell me about it. I care about their performance at crafting and controlling the message and influencing the government.

Kim and almost every member of our Board is personally connected to the illness in some way. That's part of our motivation for doing this work. But you are correct that it is not a free pass! Our personal situations are not a smoke screen to cloak poor performance. Understand our motivations, but judge our effectiveness on results.

 

[Cort]

Tell me about it. I care about their performance at crafting and controlling the message and influencing the government. (And they're completely negligent if they are not supporting the WPI financially.) Don't plead that you really care. Apologize for dropping the ball and bring you A-game. Now.

HVS - this is what I care about:

• I care about an organization that will actually take on the CDC rather than just talk about it
• I care about an organization that educates physicians so that they can better treat patients
• I care about an organization that funds cutting edge innovative research
• I care about an organization that envisions a responsive, innovative, collaborative international research network on CFS.

I care more about those things than some occasional verbal slipups.

I don't think that because the CAA didn't fund some WPI grants in the pre-XMRV era that they're negligent. I mean really - negligent! C'mon. I've listed the CAA's research projects - give me any of them and tell me that thats not the kind of stuff you want researchers studying.

 

[Dr. Yes]

Dear jspotila

Dear jspotila,

you stated:

Yes, we are very concerned about replication study failure due to patient selection or other methodology issues.

I am very concerned about that too. Could you tell us what the CAA is doing about it?

And your contingency plans in case your first ones prove insufficient? (This is a monumentally important matter, and I assume the CAA has worked out multiple strategies, as any good advocacy group would).

Also, forgive my ignorance, but are the current replication efforts using the same criteria for patient selection the WPI did? (As it would be most un-scientific not too.. and disastrous). If not, I assume the CAA is working overtime to make sure that they change their criteria to match the WPI's, right??

Thank you very much!

 

[hvs]

I don't think that because the CAA didn't fund some WPI grants in the pre-XMRV era that they're negligent.

I mean today, Cort. The priority since that day in October seems pretty clear. Not that we should study other issues, too.

 

[starryeyes]

Catch said: I'd really like to know the answer to these questions too please, jspotila. Also, is there anything we can do ourselves to ensure that Canadian defined patients are used in replication attempts? Who should we write to about this crucial issue? Thanks.

Ditto to what Catch said!

 

[hvs]

I think you are referring to the websites that are part of the CDC funded public awareness campaign. The CFIDS Association has never funded research using the empiric definition, nor has our education activities. In fact, the Association has voiced strong opposition to CDC continuing to use the flawed and overly broad empiric definition. See http://www.cfids.org/cfidslink/2009/070108.asp.

Around 2003-5 the CAA had a program for training selected patients to be available to media as representative of people with CFS. During training, the CAA recommended the trainees refer media to the CDC website if they had questions about the disease. This, it goes without saying, was directly opposed to our community's interests.

Yes, we are very concerned about replication study failure due to patient selection or other methodology issues.

Good. Can you confirm for us that the CAA has an action plan in place at this moment for blitzing the media with a forceful response within moments of the feds releasing their news? Do they have a plan in place if the feds replicate at the same rate as the WPI? At a third of the rate? At 1% of the rate?

Dr. Daniel Peterson and Dr. John Coffin addressed this issue at the CFSAC meeting on October 29.

It goes without saying that Dr. Peterson is absolutely not representative of the CAA. Quite the opposite.

Our personal situations are not a smoke screen to cloak poor performance. Understand our motivations, but judge our effectiveness on results.

Agreed.

 

[jspotila]

I am very concerned about that too. Could you tell us what the CAA is doing about it?

And your contingency plans in case your first ones prove insufficient? (This is a monumentally important matter, and I assume the CAA has worked out multiple strategies, as any good advocacy group would).

Also, forgive my ignorance, but are the current replication efforts using the same criteria for patient selection the WPI did? (As it would be most un-scientific not too.. and disastrous). If not, I assume the CAA is working overtime to make sure that they change their criteria to match the WPI's, right??

Thank you very much!

We are concerned about the patient selection, methodology and assays being used by different groups attempting to replicate the WPI study. CDC is not the only group attempting replication. There is a federal task force on XMRV, CFS and blood safety, and both Dr. Suzanne Vernon and Dr. Judy Mikovits are members.

The Association is trying to push replication studies towards true replication - the cohort selection, methodology and assays used by WPI. Understand that the Association is not funding any of the replication studies, so we have no direct control over how the work is done. We can't force a group to change their methods. What we CAN do is advocate for true replication methods by any group making the attempt, and Dr. Vernon is doing exactly that.

We are awaiting the outcomes of these studies, as well as the work of the federal task force. We will speak out on these studies when results are made public. If a replication effort failed but did not use the WPI's protocol, we will absolutely speak out on that.

 

[Dr. Yes]

For jspotila..

The Association is trying to push replication studies towards true replication - the cohort selection, methodology and assays used by WPI.

Is the CAA aware of what criteria the various studies - particularly the CDC's - are using for cohort selection? Specifically, are they using the Canadian criteria?

Understand that the Association is not funding any of the replication studies, so we have no direct control over how the work is done. We can't force a group to change their methods. What we CAN do is advocate for true replication methods by any group

I really do understand that, and I appreciate the level of difficulties you face in this effort!

We will speak out on these studies when results are made public. If a replication effort failed but did not use the WPI's protocol, we will absolutely speak out on that.

But that's what concerns me; that we (thus far) always end up criticizing past tense... In a matter of this importance I really hope that all energy is spent on advocating for proper selection long before the trials are finished, so we don't have to accept yet another setback due to lousy definitions. Would it be possible to get Congressional assistance in making sure the federal studies, at least, use the WPI selection criteria (i.e. NOT even just Fukuda)? After all, there has been federal concern already over the potential threat to blood supply safety; it may be easier than any previous time to get the CDC study appropriately "guided" to the right start.

Thanks again.

 

[Katie]

But that's what concerns me; that we (thus far) always end up criticizing past tense... In a matter of this importance I really hope that all energy is spent on advocating for proper selection long before the trials are finished, so we don't have to accept yet another setback due to lousy definitions. Would it be possible to get Congressional assistance in making sure the federal studies, at least, use the WPI selection criteria (i.e. NOT even just Fukuda)? After all, there has been federal concern already over the potential threat to blood supply safety; it may be easier than any previous time to get the CDC study appropriately "guided" to the right start.

Thanks again.

Maybe that could be said for studies abroad. We're trying to do our bit over here through the ME Association via Charles Shepard to make sure everything is done right but I can't speak for studies elsewhere in the world. American voices are still the biggest voices, especially as the link to XMRV was found on your turf, so I would hope that the CAA are planning to critique every study on XMRV, regardless of geographical location.

 

[fresh_eyes]

But that's what concerns me; that we (thus far) always end up criticizing past tense... In a matter of this importance I really hope that all energy is spent on advocating for proper selection long before the trials are finished, so we don't have to accept yet another setback due to lousy definitions. Would it be possible to get Congressional assistance in making sure the federal studies, at least, use the WPI selection criteria (i.e. NOT even just Fukuda)? After all, there has been federal concern already over the potential threat to blood supply safety; it may be easier than any previous time to get the CDC study appropriately "guided" to the right start.

Thanks again.

Dr Y, you're absolutely right. If the CAA feels that they can't speak out on flawed cohorts until after the studies are complete, perhaps we need to craft our own statement on this and get it out there - then at least we'll be on record as having predicted any flawed outcomes.

 

[jspotila]

Is the CAA aware of what criteria the various studies - particularly the CDC's - are using for cohort selection? Specifically, are they using the Canadian criteria?

I do not know if CDC is using the Canadian criteria. We are doing everything we can to address this on the front end of studies, but again - if a researcher does not want to take the Association's advice, we can't control that.

Would it be possible to get Congressional assistance in making sure the federal studies, at least, use the WPI selection criteria (i.e. NOT even just Fukuda)?

Congress does not legislate how science is done (except in extreme cases like stem cells). My personal view is that it is very unlikely that we could get any Congressional direction to CDC or other federal agencies requiring that a study be done a certain way.

 

[PoetInSF]

Yes, we are very concerned about replication study failure due to patient selection or other methodology issues.

But CDC, or anybody for that matter, can't exactly replicate WPI study unless they know exactly how WPI selected their samples. And I keep hearing that the sample profiles are not available. (Without exact sample selection criteria, two groups could pick subsets of Fukuda/Canadian and come up with entirely different results.) That's what Dr. Vernon mentioned and people were up in arms against CAA/Vernon then. In essence, it seems to me that some people are demanding CAA to blindly support WPI.