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CDC to enter sole-source contract with OMI

Ember

Senior Member
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2,115
https://www.fbo.gov/?s=opportunity&mode=form&id=aa17ceb922f2043d479fc659f4c8f808&tab=core&_cview=0

Added: Jul 30, 2012 11:10 am
Centers for Disease Control (CDC) intends on entering into a follow-on sole source contract with Open Medicine Institute (OMI). The nature of this acquisition is to collect clinical follow-up and additional data on CFS patients. This requires that the contractor has the required expertise in diagnosis and management of CFS and the infrastructure for clinical research.... OMI is the only contractor who can meet the above requirements.

Has Dr. Klimas failed to qualify? At the November CFSAC meeting, the CDC reported having:
Issued three contracts for clinical assessment of CFS to try to collect clinical data to inform decision making and revisions to the CFS case definition. CDC believes that the process has to be data driven. The data will be collected from seven different clinics. The organizations are:

• Beth Israel Medical ‐ B Natelson, PI [primary investigator]
• Neuro Immune Disorders ‐ Nancy Klimas, PI
• Open Medical Institute – A. Koglenik, D. Peterson, C. Lapp, L. Bateman, R. Podell, PIs

Slow progress was reported in June. At that CFSAC meeting, Eileen Holderman expressed surprise on learning that clinicians weren't being asked what definition they were currently using. The meeting was informed, as I recall, that Dr. Klimas was using the CCC.
 

Ember

Senior Member
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2,115
The CDC has removed its link to the quotation that I posted (with emphasis added) at the end of June:
Various terms are incorrectly used interchangeably with CFS. CFS has an internationally accepted case definition that is used in research and clinical settings. The name chronic fatigue and immune dysfunction syndrome (CFIDS) was introduced soon after CFS was defined; there is no case definition for CFIDS, and the name implies an understanding about the pathophysiology of CFS that is not fully supported in the medical literature. The name myalgic encephalomyelitis (ME) was coined in the 1950s to clarify well-documented outbreaks of disease; however, ME is accompanied by neurologic and muscular signs and has a case definition distinct from that of CFS (http://www.cdc.gov/cfs/education/wb1032/chapter1-1.html).

Here's their current statement, now placed under Overview and Definition of CFS:
A Canadian ME/CFS Clinical Case Definition [10] was developed by an international group to help clinicians and educators better inform providers on the nature and severity of the illness. This case definition requires:
  • profound fatigue
  • exercise induced relapse
  • at least one symptom in at least 2 of the 3 symptom clusters: endocrine, autonomic, and immune/inflammatory
This clinical case definition was also linked to treatment guidelines.

This definition was recently reviewed by an international group, updated, revised, and the results published in the fall of 2011, as the International Consensus Criteria for ME [11], dropping the term CFS and using the term Myalgic Encephalomyelitis (ME). This ME case definition extends the criteria to an extended number of subgroups, and proposes application in both clinical and research settings.

Dr. Klimas was among their recent course developers and subject matter experts. Yet I have difficulty imagining that she vetted the statement, "This ME case definition extends the criieria to an extended number of subgroups...."
 

Ember

Senior Member
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2,115
Is Dr. Unger following in Dr. Reeves' footsteps by shunning collaboration with scientists (such as Dr. Klimas) at academic research centres? David Tuller writes that Dr. Reeves' support among CFSAC members was further shredded by a CAA report in October 2008, stating that “the largest chunk of the program’s funding...went to a single private research organization...in sole-source or no-bid contracts....” David Tuller adds that “the financial accounting appeared to confirm a frequently heard complaint about the CDC and Dr. Reeves—that they were not taking full advantage of opportunities to collaborate with outside scientists at academic research centers.”
 

Dolphin

Senior Member
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17,567
Compared to what the CDC has done in the past, I think the CDC involving such a team is a much better option than most.
 

Ember

Senior Member
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2,115
Does preferring the outcome mean that we should wink at the process? Is it a mere slip of the tongue when the CDC refers to this contract as an acquisition? (I'm not familiar with correct legal language.) Are private institutions easier to control than academic research centres?

David Tuller quotes Kim McCleary's testimony to CFSAC in October 2008:
At least $2.7 million committed to Abt was 'in limbo'–obligated to specific projects but remaining unspent—and work on other projects was proceeding slowly and at great cost.... The financial mismanagement...“has resulted in program management coming often to this committee and telling other investigators that no funds are available for new projects or collaborations.”
It's too soon to forget.
 

Desdinova

Senior Member
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276
Location
USA
Is Dr. Unger following in Dr. Reeves' footsteps by shunning collaboration with scientists (such as Dr. Klimas) at academic research centres?


I can't help but wonder if this will be a repeat of the past.

http://www.cdc.gov/cfs/meetings/case_def_05_2000.html.
On May 3, workshop participants reviewed the presentations and recommended a course of action for future work on the CFS case definition. The participants agreed that it was premature to revise the case definition at this time and that future revisions must be based on data-driven research rather than consensus clinical opinion.
Since Dr. Unger has emphasized that this review will be data driven. Not sure if I'm interpreting things right but it seems to me that all the data will be collected from the collaborating Doctors such as Dr. Klimas and interpreted by this company then the CDC will base their decisions upon that information.
 

Ember

Senior Member
Messages
2,115
Not sure if I'm interpreting things right but it seems to me that all the data will be collected from the collaborating Doctors such as Dr. Klimas and interpreted by this company then the CDC will base their decisions upon that information.
As I read the CDC intent, all the data will be collected through “a follow-on sole source contract with Open Medicine Institute (OMI).” According to the CDC statement last November, the OMI was comprised of A. Koglenik, D. Peterson, C. Lapp, L. Bateman, R. Podell, Pis. But here, they don't name the participants.

As of June, the contractors weren't being asked to interpret the data. They weren't even being asked what definition they're currently using.

Thanks for the link!
 

Ember

Senior Member
Messages
2,115
I can't help but wonder if this will be a repeat of the past.
So far Dr. Unger stands by the Reeves et al. (2005) definition and “the estimate, based on the empiric criteria, that 4 million people in the U.S. have CFS.” David Tuller writes that “others outside the CDC dismissed the new numbers as absurdly inflated and argued that the empiric criteria, like the Oxford criteria but unlike the 2003 Canadian case definition, blurred and expanded rather than clarified the disease boundaries.”

Blurring and expanding rather than clarifying disease boundaries seems to be something that Dr. Unger learned from Dr. Reeves. The ICC recommends that ME patients “should be removed from the Reeves empirical criteria and the National Institute for Clinical Excellence (NICE) criteria for chronic fatigue syndrome.” But rather than separating ME from CFS as recommended by the ICC, the CDC now subsumes ME (ICC) under CFS and seems to be engineering its expansion as well with the statement, "This ME case definition extends the criieria to an extended number of subgroups...."

In a nod to the NICE Guidelines perhaps, Dr. Unger writes of the “Canadian Consensus Criteria of CFS/ME (sic).” Her methodology for reviewing CFS (Fukua) presupposes that there is one disease, with differences being matters only of degree. Like Reeves et al. (2005), she relies on “introducing standardized questionnaires and measurement scales to assess levels of fatigue and functional impairment” in the context of already existing domains: “We are planning to collect standardized data on all the domains of illness included in the Canadian Consensus Criteria of CFS/ME (sic), the 1994 CFS definition and the newly proposed International ME definition.”

Cort writes of Dr. Unger that:
She believes in the big box approach and a definition (Empirical Definition) that gathers together many different types of “CFS’ rather than a narrower definition which might produce a ‘clean’ group of patients. She acknowledges the need to find subsets – yet doesn’t appear to be committed to producing large enough studies to ferret them out.
In resisting a narrower definition, Dr. Unger resists too the exercise challenge:
Dr. Unger said that her group is looking at all of the instruments and cutoffs used and how they affect who does and does not meet the definition of CFS. She added that the CDC gleaned some interesting information from the exercise challenge; then the decision was made to try a different kind of challenge. This is not to say that exercise is not a good challenge, she said. Researchers want to see CFS in motion; a static picture is harder to understand than observing responses.
.
Here's Dr. Unger's more recent position on the best instruments to use:
Dr. Unger: We did not try to reach consensus or recommendations on instruments. We are saying that you have to measure function in some way, and these are some current options. We did not think we could reach consensus on what the best instruments are at this point. There is a separate group that is trying to come to consensus about what best instruments are. Even then, it will not be absolute. There will be criteria that are used to evaluate instruments.
Tellingly, Dr. Unger describes the CDC's current case-definition process this way:
We are going to start with data collection. The question being asked over and over is, how do the patients differ in people’s practices and is this really why we have some problems even though everybody calls it CFS and they are using a case definition? Is that why the findings in the laboratory are not always translatable? That is step number one.

Step number two is, if we have good measures of the domains (and as you know, the field is ongoing as to what are the best measures of the domains), then we try to say how can we capture this the best way. We as a field need to be a little schizophrenic and say yes, we can bring people in under a broader umbrella diagnosis, but then we cannot just group cases and controls. We have to be doing some stratification. We have to use a dynamic range in all of those measures. It is not enough to have just fatigue, but how much fatigue? It is not enough to have any one measure.
I read here Dr. Unger's continued rejection of a test-retest protocol. I expect her new CDC definition to again blur and expand rather than clarify disease boundaries.
 

Ember

Senior Member
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2,115
This interview of Staci Stevens might theoretically inform Dr. Unger as her group looks at “all of the instruments and cutoffs used and how they affect who does and does not meet the definition of CFS:”


“The hallmark of chronic fatigue syndrome is exercise intolerance, so studying it and understanding it and the consequences of post-exertional malaise is essential to understanding what's going on in the illness.”

“[PEM] is a very objective marker, and the way that we employ testing is a two-day test paradigm, and the second-day test allows us to objectively measure those symptoms of post-exertional malaise that very few people actually believe exists.”

“What's unique to CFS is the second day...they should be able to come back and do the exact same thing. The unique part is that, unlike heart disease patients, CFS patients can't reproduce the results.”
 

taniaaust1

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Sth Australia
As I read the CDC intent, all the data will be collected through “a follow-on sole source contract with Open Medicine Institute (OMI).” According to the CDC statement last November, the OMI was comprised of A. Koglenik, D. Peterson, C. Lapp, L. Bateman, R. Podell, Pis. But here, they don't name the participants.

As of June, the contractors weren't being asked to interpret the data. They weren't even being asked what definition they're currently using.

Thanks for the link!

If OMI is just good ME/CFS experts such as those listed above. I have no issue at all at the following quote below as it then sounds all good. Who else would we want to be be doing such a thing then our experts in this illness and have them collecting clinical follow up info and data.
Centers for Disease Control (CDC) intends on entering into a follow-on sole source contract with Open Medicine Institute (OMI). The nature of this acquisition is to collect clinical follow-up and additional data on CFS patients. This requires that the contractor has the required expertise in diagnosis and management of CFS and the infrastructure for clinical research.... OMI is the only contractor who can meet the above requirements.​
 

Ember

Senior Member
Messages
2,115
Who else would we want to be be doing such a thing then our experts in this illness and have them collecting clinical follow up info and data.
Without implying any criticism of the OMI experts listed, I have two concerns with this CDC announcement. One is with their statement, “This requires that the contractor has the required expertise in diagnosis and management of CFS and the infrastructure for clinical research.... OMI is the only contractor who can meet the above requirements.” Dr. Klimas met these requirements before. Why not now?

My other concern involves the CDC's troubling history of entered into sole-source contracts while failing to collaborate with academic research centres. Universities are able to preserve academic independence, and her university affiliation may be one of Dr. Klimas' strengths. Private institutions can be easier to control.
 

taniaaust1

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Without implying any criticism of the OMI experts listed, I have two concerns with this CDC announcement. One is with their statement, “This requires that the contractor has the required expertise in diagnosis and management of CFS and the infrastructure for clinical research.... OMI is the only contractor who can meet the above requirements.” Dr. Klimas met these requirements before. Why not now?

My other concern involves the CDC's troubling history of entered into sole-source contracts while failing to collaborate with academic research centres. Universities are able to preserve academic independence, and her university affiliation may be one of Dr. Klimas' strengths. Private institutions can be easier to control.

umm I missed that before.. That is a good question.. why isnt Dr Klimas meeting those requirements? Is it cause she was going to use the CCC definition.

Can someone find out which definition those others have agreed to use in all this?
 

Desdinova

Senior Member
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276
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To me this is inherently flawed to begin with. No one knows what definition is being used and by whom. I'm also puzzled by how you can review, improve and change your current definition by using the very guide line you want to change and improve to analyze and interpret the data that is collected?

This requires that the contractor has the required expertise in diagnosis and management of CFS and the infrastructure for clinical research....

I'm also not 100% sure that I understand what "management of CFS " is? If that company is using the CDC's CFS definition then what passes for management of CFS? So lets review things, the CDC is looking to see if they need to improve there CFS definition by collecting data gathered in-part by using the the current definition and interpreting it by using the current definition. Does anyone else see an inherent flaw with there process of gathering data to drive the revision process.

future revisions must be based on data-driven research rather than consensus clinical opinion. -Dr. Unger.
 

Ember

Senior Member
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2,115
Can someone find out which definition those others have agreed to use in all this?
According to Dr. Belay, the clinicians aren't being asked to reveal what definition they've based their selections upon. Instead they're simply being asked, “What are the cases they would classify as having CFS.” CFS is already defined, of course, by Fukuda (1994) and by Reeves (2005), but the CDC nevertheless plans to find out how well the various case definitions fare in selecting these already preselected CFS patients.

Upon “collecting as many parameters as possible that would allow us then to apply to those case definitions,” the CDC plans to use the core symptoms of the 400 selected CFS patients to create its “data-driven” redefinition. Dr. Unger hasn't decided what to call it yet.

Faced with this horribly flawed research design, perhaps Dr. Klimas decided against any further involvement. As Dr. Fletcher pointed out in June to CFSAC members, “Reeves did a lot of damage when he and the CDC made that revision of the Fukuda that opened up the case definition to a whole lot of people with depression. And so we have to be really careful about this kind of thing. It could be very damaging.”
 

taniaaust1

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Upon “collecting as many parameters as possible that would allow us then to apply to those case definitions,” the CDC plans to use the core symptoms of the 400 selected CFS patients to create its “data-driven” redefinition. Dr. Unger hasn't decided what to call it yet.

Calling the new definition Unger Disease would be better then calling it Chronic Fatigue Syndrome.

Maybe if they give it a new name after each new person who redefines the illness..at least then we wouldnt be confused at what definations are being used. :p
 

GracieJ

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Location
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My thought exactly, tania. LOL Unger Disease... that would go over big.

This reads circular, no doubt. Crazy-making all over again, defining something by a limited existing definition.

Leaving Klimas out at first seems a glaring error, but definitely I wonder if she turned down the "opportunity."
 

Desdinova

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Location
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This reads circular, no doubt. Crazy-making all over again, defining something by a limited existing definition.

Leaving Klimas out at first seems a glaring error, but definitely I wonder if she turned down the "opportunity."
No good will come out of using a flawed definition for CFS/ME based upon flawed research and beliefs to create a new one. No good will come out of this when the one in charge of directing it is clinging to the Dogma of the Bio-psychosocial health model. Dr. Kilmas in the long run may come to consider herself lucky not to have been attached to this if it turns into the fiasco It looks to be already.