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[/fright]It turns out that you can't just ask for a pot full of new money for a disease at the NIH. You have to get permission to ask first. Basically you have to get clearance or agreement from a council of your peers that that the concept or idea you have; in this case, increasing research funding for ME/CFS dramatically - is worth going after.
"Concepts" at the NIH represent early planning stages for initiatives to increase research in "understudied and significant area(s) of science." Concept clearance - which was what Vicky Whittemore was going after today - is needed before an Institute will accept proposals for significant new funding.
Clearance for a concept does not guarantee that requests for applications (RFA's), or request for proposals (RFP) or other grants will be approved. The leader of the meeting said, however, that it was "not uncommon" that cleared concepts turn into RFA's and grants.
Vicky Whittemore
Vicky Whittemore quickly made her case. Myalgic encephalomyelitis/chronic fatigue syndrome is a very serious disease that typically begins with an infection. She said she had met patients who had been sick for over 30 years. She asserted a desperate need to bolster research and increase researcher capacity existed.
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[/fleft] She wasn't talking about simply increasing research; her goal is to develop a research infrastructure that works - that puts ME/CFS on a par with other established diseases. In essence she was talking about a new way of studying ME/CFS.
In fact, the ideas she laid out have been germinating in the ME/CFS research for some time. Probably a decade ago Suzanne Vernon challenged the ME/CFS research community to develop gold standards for research that would allow researchers to generalize their results across studies; in other words - produce studies that make a difference. Some work was done to that end but that idea's time had not yet come.
Ron Davis's ambitious Open Medicine Foundation proposal to create a consortium of researchers to tackle ME/CFS in a methodical and organized way surely helped birth the second part of Whittemore's proposal. She sought to develop a consortium of research centers which used similar protocols, data elements and which developed large patient cohorts for study.
These research centers would approach chronic fatigue syndrome using a variety of approaches. Each would be tied to the other via a central data network. Encased within the consortium concept would be the ability to add more sites in the future.
Whittemore said she and others were astonished to learn there were no training grants to develop new researchers in ME/CFS. She noted that currently there was little communication between doctors and researchers that could enable translational efforts in the field. She stated a program called NCATS developed at the NIH that fosters those kinds of partnerships would help guide the Working Groups efforts.
Embedded but not strictly mentioned in Whittemore's proposal were RFA's, Centers of Excellence and clinical trials. All would be needed to build the infrastructure the Working Group asserts is necessary.
Unanimous Vote
Her presentation done Vicki Whittemore asked for questions. I held my breath. How did the Council of her peers respond? With just two questions; one regarding diagnostic problems and the other recommending an NCAT program.
Whittemore stated that the Working Group is working with the FDA and the CDC to develop common data elements to be used to subtype patients. She believes ME/CFS probably consists of a large spectrum of diseases. Following the NCAT model, patients would be involved in the Consortiium's work.
With that it was on to the Council vote. I held my breath again but again it was anticlimactic. Most people raised their hands "yes", some didn't vote but no one abstained or said no; the vote was unanimous, and the concept to build a new research infrastructure for myalgic encephalomyelitis/chronic fatigue syndrome was approved.
I wouldn't call the group enthusiastic - nobody applauded the idea - but they weren't antagonistic either, and most importantly, they passed the concept through.
This "concept" needed to pass only one Council meeting - this one. Vicky Whittemore said the next step was to "finalize the details for the funding opportunity announcements and get agreement from all of the Institutes."
The Consortium Centers
While nothing is certain lets speculate on possible consortium centers. My guess is that the Centers with the greatest possibility of becoming consortia are those that a) already have developed research/treatment programs, that have shown their ability to successfully deliver on funding and are known to the NIH. I've probably forgotten somebody (lol) but these came to mind.
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[/fright]The Bateman-Horne Center - the Bateman Horne Center is just being built but what better way to enhance ME/CFS research than giving Lucinda Bateman - an experienced and respected doctor - and Suzanne Vernon - a creative disrupter in this field if there ever was one - a chance to grow their Center rapidly. Suzanne Vernon is bursting with ideas, and has brought more new research talent into this field than anyone. Dr. Bateman has probably been involved in every major ME/CFS and FM clinical trial over the past ten years, is acknowledged to be a superb diagnostician, and has participated in every way imaginable. Plus this field just does better when people like Suzanne Vernon have funds to play with.
Center for Infection and Immunity - Mady Hornig recently stated she hopes the CII becomes a Center of Excellence for ME/CFS. It's hard to imagine that not happening given the immense amount of research occurring at the CII, the large biobank it has access to, and it's top research and medical talent.
The CDC's CFS Research Program - this program may have the largest budget of any ME/CFS program and it's hooked into treatment with its massive ME/CFS multisite program. It's inclusion in the Consortium seems a given. (Therefore it is not included in the poll).
Chronic Fatigue Syndrome Research Center at Stanford - At first blush, Dr. Montoya's Chronic Fatigue Syndrome Research Center seems like a natural. Montoya is a great spokesman for ME/CFS, and he's ensconced in one of the top medical Universities in the country. Plus Dr. Montoya has been able to enlist several outside researchers in his effort to understand ME/CFS.
The Chronic Fatigue Syndrome Research Center's record of publication, however, has been meager. Dr. Montoya's five million dollar donation in 2008 (and he's surely had others) has resulted thus far, in just two publications; one by a researcher (Jarred Younger) who's left Stanford. Montoya has also lost the services of the Zinns. Besides, with the Ron Davis/Open Medicine Foundation effort flourishing there's room for only one research/treatment consortium at Stanford.
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[/fleft]Nancy Klimas's Institute for Neuroimmune Medicine - Ditto with Dr. Klimas's effort. The Institute for Neuroimmune Medicine, with its treatment and research facilities, is already a COE. Dr. Klimas and Dr. Fletcher are able to consistently get grants and produce papers. Plus Dr. Klimas has done everything and is respected everywhere. It's hard to imagine that Dr. Klimas' venue wouldn't be near the top of the list.
Jarred Younger's Neuroinflammation, Pain and Fatigue Laboratory - Jarred Younger is a dynamic young researcher who's shown he's able to get grants and communicate effectively with the patient population. His lab has grown rapidly, he's developing new technology, and he appears to have full backing of a major University (University of Alabama at Birmingham). He does not have a treatment center as yet but hopes to get one and to initiate speedy treatment trials in the future. If the Working Group's Initiative takes off, sooner or later Jarred Younger is going to be involved.
Open Medicine Foundation/Ron Davis group - Ron Davis is new to ME/CFS research but the talent he has gathered around him, the money the OMF has been able to raise to fund his work, and the Open Medicine Institute's nearby presence with its ME/CFS knowledgeable practitioners makes this group an obvious center. Ron Davis is the big draw but let's not forget Dr. Kogelnik's vision for the OMI and the chronic fatigue syndrome field. He birthed the multi-site project that is consuming much of the CDC's CFS groups time and resources, is bursting with ideas about how to use bioinformatics and the social media to inform research, and founded the Open Medicine Foundation.
The Solve ME/CFS Initiative (SMCI) - The SMCI has decades of experience funding research, the most productive Biobank in the business, a new patient registry, a dynamic new research director and will soon begin funding a new round of pilot grants. It's funded more significant pilot studies than any other organization, and is connected every which way with researchers, doctors and the feds. It doesn't have a physical infrastructure but it's got to fit in here somewhere.
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[/fright]Simmaron Research Foundation - the Simmaron Research Foundation with Dr. Peterson has shown time and time again that it can deliver in its collaborations with others. It's engaged in numerous research projects, including quite a few it has initiated. and it's shown the ability to get NIH grants. The question with the SRF is infrastructure. Dr. Peterson has a medium sized clinic with little lab space. Would Dr. Peterson want or be able to expand?
The SRF's questions immediately bring to mind a nearby entity that has an excellent lab and the space to fulfill the needs of COE. That, of course, is the....
Whittemore Peterson Institute - Now the Nevada Center for Biomedical Research (NVCBR) - Dr. Peterson stepped away from the WPI before it got fully started and his departure was timely given the chaos that soon enveloped the WPI. This is a different, soberer NVCBR now, though.
It's simply a beautiful facility and has a wonderful lab and it's fully embedded at the University of Nevada at Reno. Annette Whittemore has built a facility that could and should be a focal point for ME/CFS treatment and research. Structurally it's a perfect site for a COE, but it might need a Dr. Peterson and his many connections to get the nod. Could Annette Whittemore and Dr. Peterson join forces again?
Hopefully the NVCBR's best years are ahead of it.
"Concepts" at the NIH represent early planning stages for initiatives to increase research in "understudied and significant area(s) of science." Concept clearance - which was what Vicky Whittemore was going after today - is needed before an Institute will accept proposals for significant new funding.
Clearance for a concept does not guarantee that requests for applications (RFA's), or request for proposals (RFP) or other grants will be approved. The leader of the meeting said, however, that it was "not uncommon" that cleared concepts turn into RFA's and grants.
Vicky Whittemore
Vicky Whittemore quickly made her case. Myalgic encephalomyelitis/chronic fatigue syndrome is a very serious disease that typically begins with an infection. She said she had met patients who had been sick for over 30 years. She asserted a desperate need to bolster research and increase researcher capacity existed.
[fleft]
In fact, the ideas she laid out have been germinating in the ME/CFS research for some time. Probably a decade ago Suzanne Vernon challenged the ME/CFS research community to develop gold standards for research that would allow researchers to generalize their results across studies; in other words - produce studies that make a difference. Some work was done to that end but that idea's time had not yet come.
Ron Davis's ambitious Open Medicine Foundation proposal to create a consortium of researchers to tackle ME/CFS in a methodical and organized way surely helped birth the second part of Whittemore's proposal. She sought to develop a consortium of research centers which used similar protocols, data elements and which developed large patient cohorts for study.
These research centers would approach chronic fatigue syndrome using a variety of approaches. Each would be tied to the other via a central data network. Encased within the consortium concept would be the ability to add more sites in the future.
Whittemore said she and others were astonished to learn there were no training grants to develop new researchers in ME/CFS. She noted that currently there was little communication between doctors and researchers that could enable translational efforts in the field. She stated a program called NCATS developed at the NIH that fosters those kinds of partnerships would help guide the Working Groups efforts.
Embedded but not strictly mentioned in Whittemore's proposal were RFA's, Centers of Excellence and clinical trials. All would be needed to build the infrastructure the Working Group asserts is necessary.
Unanimous Vote
Her presentation done Vicki Whittemore asked for questions. I held my breath. How did the Council of her peers respond? With just two questions; one regarding diagnostic problems and the other recommending an NCAT program.
Whittemore stated that the Working Group is working with the FDA and the CDC to develop common data elements to be used to subtype patients. She believes ME/CFS probably consists of a large spectrum of diseases. Following the NCAT model, patients would be involved in the Consortiium's work.
With that it was on to the Council vote. I held my breath again but again it was anticlimactic. Most people raised their hands "yes", some didn't vote but no one abstained or said no; the vote was unanimous, and the concept to build a new research infrastructure for myalgic encephalomyelitis/chronic fatigue syndrome was approved.
I wouldn't call the group enthusiastic - nobody applauded the idea - but they weren't antagonistic either, and most importantly, they passed the concept through.
This "concept" needed to pass only one Council meeting - this one. Vicky Whittemore said the next step was to "finalize the details for the funding opportunity announcements and get agreement from all of the Institutes."
The Consortium Centers
While nothing is certain lets speculate on possible consortium centers. My guess is that the Centers with the greatest possibility of becoming consortia are those that a) already have developed research/treatment programs, that have shown their ability to successfully deliver on funding and are known to the NIH. I've probably forgotten somebody (lol) but these came to mind.
[fright]
Center for Infection and Immunity - Mady Hornig recently stated she hopes the CII becomes a Center of Excellence for ME/CFS. It's hard to imagine that not happening given the immense amount of research occurring at the CII, the large biobank it has access to, and it's top research and medical talent.
The CDC's CFS Research Program - this program may have the largest budget of any ME/CFS program and it's hooked into treatment with its massive ME/CFS multisite program. It's inclusion in the Consortium seems a given. (Therefore it is not included in the poll).
Chronic Fatigue Syndrome Research Center at Stanford - At first blush, Dr. Montoya's Chronic Fatigue Syndrome Research Center seems like a natural. Montoya is a great spokesman for ME/CFS, and he's ensconced in one of the top medical Universities in the country. Plus Dr. Montoya has been able to enlist several outside researchers in his effort to understand ME/CFS.
The Chronic Fatigue Syndrome Research Center's record of publication, however, has been meager. Dr. Montoya's five million dollar donation in 2008 (and he's surely had others) has resulted thus far, in just two publications; one by a researcher (Jarred Younger) who's left Stanford. Montoya has also lost the services of the Zinns. Besides, with the Ron Davis/Open Medicine Foundation effort flourishing there's room for only one research/treatment consortium at Stanford.
[fleft]
Jarred Younger's Neuroinflammation, Pain and Fatigue Laboratory - Jarred Younger is a dynamic young researcher who's shown he's able to get grants and communicate effectively with the patient population. His lab has grown rapidly, he's developing new technology, and he appears to have full backing of a major University (University of Alabama at Birmingham). He does not have a treatment center as yet but hopes to get one and to initiate speedy treatment trials in the future. If the Working Group's Initiative takes off, sooner or later Jarred Younger is going to be involved.
Open Medicine Foundation/Ron Davis group - Ron Davis is new to ME/CFS research but the talent he has gathered around him, the money the OMF has been able to raise to fund his work, and the Open Medicine Institute's nearby presence with its ME/CFS knowledgeable practitioners makes this group an obvious center. Ron Davis is the big draw but let's not forget Dr. Kogelnik's vision for the OMI and the chronic fatigue syndrome field. He birthed the multi-site project that is consuming much of the CDC's CFS groups time and resources, is bursting with ideas about how to use bioinformatics and the social media to inform research, and founded the Open Medicine Foundation.
The Solve ME/CFS Initiative (SMCI) - The SMCI has decades of experience funding research, the most productive Biobank in the business, a new patient registry, a dynamic new research director and will soon begin funding a new round of pilot grants. It's funded more significant pilot studies than any other organization, and is connected every which way with researchers, doctors and the feds. It doesn't have a physical infrastructure but it's got to fit in here somewhere.
[fright]
The SRF's questions immediately bring to mind a nearby entity that has an excellent lab and the space to fulfill the needs of COE. That, of course, is the....
Whittemore Peterson Institute - Now the Nevada Center for Biomedical Research (NVCBR) - Dr. Peterson stepped away from the WPI before it got fully started and his departure was timely given the chaos that soon enveloped the WPI. This is a different, soberer NVCBR now, though.
It's simply a beautiful facility and has a wonderful lab and it's fully embedded at the University of Nevada at Reno. Annette Whittemore has built a facility that could and should be a focal point for ME/CFS treatment and research. Structurally it's a perfect site for a COE, but it might need a Dr. Peterson and his many connections to get the nod. Could Annette Whittemore and Dr. Peterson join forces again?
Hopefully the NVCBR's best years are ahead of it.
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