Thanks - it's a great article and very heartening. I'm very grateful to the CFSAC members for their hard work.
I highly recommend that every reads Mary's article.
The P2P Draft report is out
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Thanks - it's a great article and very heartening. I'm very grateful to the CFSAC members for their hard work.
I highly recommend that every reads Mary's article.
Nielk
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You can store your comments of the P2P at -
Comments to the NIH's P2P can be stored at OccupyCFS: http://www.occupycfs.com/2015/01/10/p2p-library-now-available/
Comments in opposition to P2P whether sent in to P2P, HHS and/or CFSAC can be stored at MEAdvocacy.org:http://www.meadvocacy.org/post_your_p2p_comments_here
Comments to the NIH's P2P can be stored at OccupyCFS: http://www.occupycfs.com/2015/01/10/p2p-library-now-available/
Comments in opposition to P2P whether sent in to P2P, HHS and/or CFSAC can be stored at MEAdvocacy.org:http://www.meadvocacy.org/post_your_p2p_comments_here
I received an e-mail from my contact at the ODP, letting me know that they will be available on Tues. afternoon - Jan. 20th (EST) to discuss some additional questions I have about the P2P process. These questions relate to the timing of the release of the final report, as well as questions about the number of written Public Comments to the Draft Report, which were received by the ODP and information about Comments/Questions received as part of the P2P workshop.
I am sorry that I have not yet been able to get an answer to the timing of the release date of the P2P Report because I know that this information is important to the ME/CFS Community. Hopefully, I will be able to attain this information on Tuesday (note - Monday is a government holiday) following my phone conversation with the ODP.
jimells
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The CFSAC report to the P2P panel is *not* what NIH wants to see. I wonder if they have figured out that the P2P process is turning into a loose canon.
Maybe she should be looking for a parachute...
Susan Maier said:"Fasten your seatbelts [sic] and return your tray tables to the upright position because its’ going to be a bumpy ride"
Maybe she should be looking for a parachute...
Sing
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We are getting together a real ball team now--that is my response to your post, jimells! I hope there will be lots of surprises and effective action.
jimells
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Pat Fero's statement is worth the time to read:
Near the end she points out that the research centers were closed in 2002, the same year we were dumped on ORWH - how did this happen, and who was behind it? Are these meeting minutes in already available, or would they require more FOIA fights?
Near the end she points out that the research centers were closed in 2002, the same year we were dumped on ORWH - how did this happen, and who was behind it? Are these meeting minutes in already available, or would they require more FOIA fights?
Bob
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Does anyone happen to know which paper by Lenny Jason demonstrates that Fukuda can select primary psychiatric patients? Or isn't there one?
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Bob
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Doing some last minute stuff, and thought I'd post this quote from Lenny Jason, in case helpful:
Jason LA, Sunnquist M, Brown A, Evans M, Vernon SD, Furst J, Simonis V. (2014) Fatigue. 2:40-56. Examining case definition criteria for chronic fatigue syndrome and myalgic encephalomyelitis.
"Because the Fukuda CFS criteria require only four symptoms of a possible eight, participants could meet criteria without having prominent CFS symptoms, such as post-exertional malaise and memory and concentration problems. The Fukuda CFS case definition has been criticized for not requiring core CFS symptoms [8] and lacking clear operational definitions
and guidelines to assist researchers in its application.[9]"
Jason LA, Sunnquist M, Brown A, Evans M, Vernon SD, Furst J, Simonis V. (2014) Fatigue. 2:40-56. Examining case definition criteria for chronic fatigue syndrome and myalgic encephalomyelitis.
"Because the Fukuda CFS criteria require only four symptoms of a possible eight, participants could meet criteria without having prominent CFS symptoms, such as post-exertional malaise and memory and concentration problems. The Fukuda CFS case definition has been criticized for not requiring core CFS symptoms [8] and lacking clear operational definitions
and guidelines to assist researchers in its application.[9]"
Sing
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In my comments, I recommended that Fukuda be retired along with Oxford due to this problem that patients could qualify without core symptoms.
jimells
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Invest in ME submitted a very critical report and concludes with
If the NIH were truly interested in doing something substantive, this conference could be a good start.
If the NIH were truly interested in doing something substantive, this conference could be a good start.
Nielk
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IACFS/ME Response to P2P Draft Report on ME/CFS
Dear NIH P2P Panel Members,
As board members of the International Association for Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis (IACFS/ME), the largest international group of clinicians, researchers, and other professionals dedicated to the care and research of patients with ME/CFS, we hope that your report will have a positive influence on the field, our organization’s members, and the patients/ families we serve.
Generally we agree with the majority of the Panel’s recommendations but believe that the elephant in the room – research funding – alluded to in the report (e.g. Line 8) needs to be addressed more strongly and specifically. Federal funding for ME/CFS research over the last 3 decades has been inadequate to the broad-ranging and complex challenges presented by this illness. In recent years, only $5-$6 million annually has been awarded on an extramural basis, resulting in ME/CFS being the least-funded out of 240+ conditions that NIH tracks annually. (http://report.nih.gov/categorical_spending.aspx) Over the last 25 years that IACFS/ME has been in existence, we have seen few new researchers enter the field, a flat publication rate over the past decade, and continuing stigma surrounding the illness.
This state of affairs is particularly concerning given the costs to society of this illness with respect to lost productivity and high health care costs. To whom do the one million US patients with ME/CFS turn to be reassured that their illness is being taken seriously with substantive commitments to scientific research? Only the federal government, and NIH in particular, has the ability to make such commitments.
Many of the same recommendations and concerns highlighted by the Panel have been brought up by members of our organization over the years. For example, last Spring, several of our board members who also served on DHHS’ CFS Advisory Committee suggested that NIH establish and support a data/ biobank-sharing platform and/or issue a Request for Applications focusing on specific areas to jumpstart research. Unfortunately, the recommendations were not accepted or acted upon by NIH. (http://www.hhs.gov/advcomcfs/recommendations/hhs-cfsac-recommendations-response.pdf)
The reasons given were that there were too few ME/CFS researchers to invest the funds for such a platform, that such funding would take away money from other ME/CFS projects, and that since so little was known about ME/CFS, a RFA was not the right mechanism for funding. Interestingly, the letter then went on to state “RFAs are designed to build upon recommendations that have been identified……. [through] workshops and conferences” yet no RFA was issued for ME/CFS after NIH’s State-of-the-Knowledge Workshop on ME/CFS in 2011 despite the efforts of then-Trans-NIH-Working-Group head Dr. Dennis Mangan. The letter concludes by suggesting that mentored career development, student, and post-doctoral training grants be used.
(The last time NIH issued and RFA for ME/CFS, in 2007, a number of successful projects were funded.) (http://www.hhs.gov/advcomcfs/recommendations/06142014.html)
The essential message conveyed is that the US government does not want to invest additional funds because not enough is known about the disease and there are not enough researchers. Yet a critical reason why we have a dearth of researchers and knowledge is because of the poor funding situation, which has endured for the past 3 decades. Lack of investment in basic research by the government also impacts other sources of ME/CFS research funding. In April of 2013, the US Food and Drug Administration hosted a Drug Development workshop for ME/CFS. The pharmaceutical representatives who attended cited poor understanding of the basic pathophysiology of ME/CFS as a major reason for the reluctance of their companies to invest in ME/CFS clinical research.
Finally, we believe it would be beneficial to change the institutional affiliation of ME/CFS from the Office for Research on Women’s Health (ORWH) to an Institute with research funds to distribute. ME/CFS may have been placed under ORWH originally so that funding could be coordinated across institutes but that has not been successful. In fact, the Program Announcement for ME/CFS includes an October 2014 note that several Institutes – including NIA, NIDDK, NIEHS, and NCCAM – have withdrawn their participation. (http://grants.nih.gov/grants/guide/pa-files/PAR-12-032.html)
Thus we encourage the NIH to consider assigning the management of CFS/ME research to a single NIH Institute and provide that Institute with the responsibility and appropriate funding to effectively manage the research effort in this disease. We respectfully suggest either NINDS or NIAID as the primary Institute as multiple studies demonstrate that neurologic, infectious, and autoimmune components are present in this illness. To make significant progress, funding needs to be provided on par with that of other diseases that are similarly prevalent and disabling. For example, multiple sclerosis and systemic lupus erythematosus are both funded at more than ten times the level ($112-$152 million and $92-$127 million annually respectively) of ME/CFS although ME/CFS, even using a conservative estimate, may be more common.
We respectfully ask that the NIH Panel highlight the inadequate research funding of ME/CFS and link this core premise to specific recommendations for new funding initiatives, with dollar amounts, mechanisms, and deadlines, to begin to address the current underfunded status of this illness.
We also agree with the Panel’s suggestion that carefully constructed and operationalized case definitions are needed for research but disagree that the main issue is lack of agreement on a single research case definition. A single case definition, the 1994 Fukuda case definition, has been used for the majority of the studies worldwide. However, there are concerns that Fukuda is neither sensitive nor specific enough to capture the patient population it is meant to capture; furthermore, it has not been updated in 20 years to reflect clinician/ patient experience, substantial new evidence from more recent studies on symptom frequencies, and newer case definitions in ME/CFS.
Thus, we ask that the Panel instead emphasize that any research case definition used be based on clinician/ patient experience and the scientific literature, be operationalized well enough that it is easily duplicated across studies by different researchers, and that it be validated and reassessed in a timely manner.
Thank you for this opportunity to comment on the Draft Executive Summary. We hope that you will take our suggestions into account and will feel no hesitation in contacting us if we can be of further service.
Sincerely,
Fred Friedberg, Ph.D.
President, IACFS/ME
Staci R Stevens, M.A.
Founder: Workwell Foundation; Ripon, CA
Co-Vice President, IACFS/ME
Rosamund Vallings, MNZM, MBBS
Howick Health and Medical Center; Auckland, New Zealand
Secretary, IACFS/ME
Julia Newton, MD, PhD
Dean of Clinical Medicine & Professor of Ageing and Medicine
Clinical Academic Office, The Medical School, Newcastle University; New Castle upon Tyne,
United Kingdom
Board member, IACFS/ME
Jon D. Kaiser, MD
Clinical Faculty, Dept. of Medicine, UCSF Medical School; San Francisco, CA
Medical Director, K-PAX Pharmaceuticals, Inc.
Board Member, IACFS/ME
Steven P. Krafchick MPH, JD
Krafchick Law Firm PLLC, Legal Services for Injured and Disabled People; Seattle, WA
Board member, IACFS/ME
Dear NIH P2P Panel Members,
As board members of the International Association for Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis (IACFS/ME), the largest international group of clinicians, researchers, and other professionals dedicated to the care and research of patients with ME/CFS, we hope that your report will have a positive influence on the field, our organization’s members, and the patients/ families we serve.
Generally we agree with the majority of the Panel’s recommendations but believe that the elephant in the room – research funding – alluded to in the report (e.g. Line 8) needs to be addressed more strongly and specifically. Federal funding for ME/CFS research over the last 3 decades has been inadequate to the broad-ranging and complex challenges presented by this illness. In recent years, only $5-$6 million annually has been awarded on an extramural basis, resulting in ME/CFS being the least-funded out of 240+ conditions that NIH tracks annually. (http://report.nih.gov/categorical_spending.aspx) Over the last 25 years that IACFS/ME has been in existence, we have seen few new researchers enter the field, a flat publication rate over the past decade, and continuing stigma surrounding the illness.
This state of affairs is particularly concerning given the costs to society of this illness with respect to lost productivity and high health care costs. To whom do the one million US patients with ME/CFS turn to be reassured that their illness is being taken seriously with substantive commitments to scientific research? Only the federal government, and NIH in particular, has the ability to make such commitments.
Many of the same recommendations and concerns highlighted by the Panel have been brought up by members of our organization over the years. For example, last Spring, several of our board members who also served on DHHS’ CFS Advisory Committee suggested that NIH establish and support a data/ biobank-sharing platform and/or issue a Request for Applications focusing on specific areas to jumpstart research. Unfortunately, the recommendations were not accepted or acted upon by NIH. (http://www.hhs.gov/advcomcfs/recommendations/hhs-cfsac-recommendations-response.pdf)
The reasons given were that there were too few ME/CFS researchers to invest the funds for such a platform, that such funding would take away money from other ME/CFS projects, and that since so little was known about ME/CFS, a RFA was not the right mechanism for funding. Interestingly, the letter then went on to state “RFAs are designed to build upon recommendations that have been identified……. [through] workshops and conferences” yet no RFA was issued for ME/CFS after NIH’s State-of-the-Knowledge Workshop on ME/CFS in 2011 despite the efforts of then-Trans-NIH-Working-Group head Dr. Dennis Mangan. The letter concludes by suggesting that mentored career development, student, and post-doctoral training grants be used.
(The last time NIH issued and RFA for ME/CFS, in 2007, a number of successful projects were funded.) (http://www.hhs.gov/advcomcfs/recommendations/06142014.html)
The essential message conveyed is that the US government does not want to invest additional funds because not enough is known about the disease and there are not enough researchers. Yet a critical reason why we have a dearth of researchers and knowledge is because of the poor funding situation, which has endured for the past 3 decades. Lack of investment in basic research by the government also impacts other sources of ME/CFS research funding. In April of 2013, the US Food and Drug Administration hosted a Drug Development workshop for ME/CFS. The pharmaceutical representatives who attended cited poor understanding of the basic pathophysiology of ME/CFS as a major reason for the reluctance of their companies to invest in ME/CFS clinical research.
Finally, we believe it would be beneficial to change the institutional affiliation of ME/CFS from the Office for Research on Women’s Health (ORWH) to an Institute with research funds to distribute. ME/CFS may have been placed under ORWH originally so that funding could be coordinated across institutes but that has not been successful. In fact, the Program Announcement for ME/CFS includes an October 2014 note that several Institutes – including NIA, NIDDK, NIEHS, and NCCAM – have withdrawn their participation. (http://grants.nih.gov/grants/guide/pa-files/PAR-12-032.html)
Thus we encourage the NIH to consider assigning the management of CFS/ME research to a single NIH Institute and provide that Institute with the responsibility and appropriate funding to effectively manage the research effort in this disease. We respectfully suggest either NINDS or NIAID as the primary Institute as multiple studies demonstrate that neurologic, infectious, and autoimmune components are present in this illness. To make significant progress, funding needs to be provided on par with that of other diseases that are similarly prevalent and disabling. For example, multiple sclerosis and systemic lupus erythematosus are both funded at more than ten times the level ($112-$152 million and $92-$127 million annually respectively) of ME/CFS although ME/CFS, even using a conservative estimate, may be more common.
We respectfully ask that the NIH Panel highlight the inadequate research funding of ME/CFS and link this core premise to specific recommendations for new funding initiatives, with dollar amounts, mechanisms, and deadlines, to begin to address the current underfunded status of this illness.
We also agree with the Panel’s suggestion that carefully constructed and operationalized case definitions are needed for research but disagree that the main issue is lack of agreement on a single research case definition. A single case definition, the 1994 Fukuda case definition, has been used for the majority of the studies worldwide. However, there are concerns that Fukuda is neither sensitive nor specific enough to capture the patient population it is meant to capture; furthermore, it has not been updated in 20 years to reflect clinician/ patient experience, substantial new evidence from more recent studies on symptom frequencies, and newer case definitions in ME/CFS.
Thus, we ask that the Panel instead emphasize that any research case definition used be based on clinician/ patient experience and the scientific literature, be operationalized well enough that it is easily duplicated across studies by different researchers, and that it be validated and reassessed in a timely manner.
Thank you for this opportunity to comment on the Draft Executive Summary. We hope that you will take our suggestions into account and will feel no hesitation in contacting us if we can be of further service.
Sincerely,
Fred Friedberg, Ph.D.
President, IACFS/ME
Staci R Stevens, M.A.
Founder: Workwell Foundation; Ripon, CA
Co-Vice President, IACFS/ME
Rosamund Vallings, MNZM, MBBS
Howick Health and Medical Center; Auckland, New Zealand
Secretary, IACFS/ME
Julia Newton, MD, PhD
Dean of Clinical Medicine & Professor of Ageing and Medicine
Clinical Academic Office, The Medical School, Newcastle University; New Castle upon Tyne,
United Kingdom
Board member, IACFS/ME
Jon D. Kaiser, MD
Clinical Faculty, Dept. of Medicine, UCSF Medical School; San Francisco, CA
Medical Director, K-PAX Pharmaceuticals, Inc.
Board Member, IACFS/ME
Steven P. Krafchick MPH, JD
Krafchick Law Firm PLLC, Legal Services for Injured and Disabled People; Seattle, WA
Board member, IACFS/ME
Nielk
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It's pretty shocking that theIACFS/ME did not find a problem with the draft report except for funding.
In addition the fact that they do not mention the Fact that we have an improvement on the Fukuda - the CCC and ICC is unforgivable!
In addition the fact that they do not mention the Fact that we have an improvement on the Fukuda - the CCC and ICC is unforgivable!
@Nielk - do you know if IACFS/ME has been asked for details about their comments?
I am wondering for instance, if limiting the scope of their comments had something to do with needing to reach consensus.
I also note that there are two new board members listed on the letter. Kaiser and Krafchick. I imagine that Steve Krafchick (based on his stances when he was on the CFSAC) may have wanted additional things included.
But Kaiser is less well known.
Kaiser was at the P2P meeting and I would appreciate other people's assessment of Kaiser's questions and comments as I think I may have misinterpreted what he said.
I am wondering for instance, if limiting the scope of their comments had something to do with needing to reach consensus.
I also note that there are two new board members listed on the letter. Kaiser and Krafchick. I imagine that Steve Krafchick (based on his stances when he was on the CFSAC) may have wanted additional things included.
But Kaiser is less well known.
Kaiser was at the P2P meeting and I would appreciate other people's assessment of Kaiser's questions and comments as I think I may have misinterpreted what he said.
Nielk
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I don't know if they needed a consensus. I saw their comment posted in Co-cure.
I also noticed Mr. Kraftchick's name as a signee. Mr. Kraftchick was a member of CFSAC when the 2012 recommendation was created and was outspoken in terms of making sure that they start with the CCC.
Bob
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In case helpful for anyone in the future, this is the paper...
Jason LA, Evans M, Brown A, Brown M, Porter N, Hunnell J, Anderson V, Lerch A. (2010) Sensitivity and Specificity of the CDC Empirical Chronic Fatigue Syndrome Case Definition. Psychology 1:9-16. doi:10.4236/psych.2010.11002
Quote:
"It is possible that some patients with MDD also have chronic fatigue and four CFS Fukuda et al. [1] symptoms that can occur with depression (e.g., unrefreshing sleep, joint pain, muscle pain, impairment in concentration). Fatigue and these four minor symptoms are also defining criteria for CFS, so it is possible that some patients with a primary affective disorder could be misdiagnosed as having CFS."
So, Jason et al. (2010) raise the possibility that some "patients with a primary affective disorder could be misdiagnosed as having CFS", when using Fukuda et al. (1994). With reference to Fukuda et al. (1994), Jason et al. (2010) assert that it is possible for a major depressive disorder patient to be misdiagnosed with CFS, if the patient presents with ‘fatigue’ and four other concurrent Fukuda symptoms that can occur with depression i.e. unrefreshing sleep; joint pain; muscle pain; and impairment in concentration.
Should that be $51 billion rather than $54 billion? Or did you include other data?
This looks prescient given David Tuller's work on the PACE Trial, etc.