Nielk
Senior Member
- Messages
- 6,970
Chronological events:
October 2012
CFSAC’s voting members issued a recommendationto the secretary of HHS stating:
‘that you will promptly convene (by 12/31/12 or as soon as possible thereafter) at least one stakeholders’ (ME/CFS experts, patients, advocates) workshop in consultation with CFSAC members to reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian Consensus Definition for discussion purposes. (10/12)’
August 27, 2013
HHS announces a sole solicitationwith the Institute of Medicine (OMI) for a study on diagnostic criteria for ME/CFS.
'Clinicians and medical professionals disagree on many aspects of ME/CFS, ranging from frank disbelief in the illness to confusion about the application of clinical diagnostic criteria. In collaboration with CFSAC ex officio agencies, OASH will request that the IOM develop consensus clinical diagnostic criteria for this disorder. A widely accepted clinical definition and a clear distinction from clinical trials and research case definitions would aid in advancing clinical care, drug development, and basic and translational research for ME/CFS. This study would also demonstrate HHS' commitment and aggressive pursuit of solutions to this poorly-understood and disabling condition.'
September 4, 2013
HHS announces; “Because of all of the concern from the public surrounding this potential sole source requisition, we have decided to discontinue this request.”September 20, 2013
The National Alliance for Myalgic Encephalomyelitis sent a letter to HHS showing their opposition to their solicitation of the contract with IOM.
‘In defiance of President Obama’s Open Government Initiative, HHS is pursuing the IOM
contract unilaterally and with disregard for the overwhelming opposition to it from the ME
community and advice from HHS’s own “Chronic Fatigue Syndrome” Advisory Committee
(CFSAC). ‘
September 23, 2013
HHS, through the CFSAC listserv sends an announcement of their contract with IOM to start their study on clinical diagnostic criteria for ME/CFS.
‘We are pleased to announce that the Institute of Medicine (IOM) will begin conducting a study on Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome this month. This study grew out of the 2012 CFSAC recommendation to the Secretary to convene a workshop to “reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS.” Because the use of and audience for case definitions for research and clinical care are very different, HHS decided that separate processes were needed to develop them. The NIH is convening an Evidence-based
Methodology Workshop process that will consider case definitions appropriate for ME/CFS research and the IOM will address the clinical diagnostic portion of the recommendation.’
The same night a lettersigned by 35 ME/CFS expert clinicians and experts was sent to HHS urging them to follow their lead and adopt the CCC and to cancel the IOM contract.
‘We strongly urge the Department of Health and Human Services (HHS) to follow our lead by
using the CCC as the sole case definition for ME/CFS in all of the Department’s activities
related to this disease.
In addition, we strongly urge you to abandon efforts to reach out to groups such as the Institute
of Medicine (IOM) that lack the needed expertise to develop “clinical diagnostic criteria” for
ME/CFS. Since the expert ME/CFS scientific and medical community has developed and
adopted a case definition for research and clinical purposes, this effort is unnecessary and
would waste scarce taxpayer funds that would be much better directed toward funding research
on this disease. Worse, this effort threatens to move ME/CFS science backward by engaging
non-experts in the development of a case definition for a complex disease about which they are
not knowledgeable.’
September 25, 2013
A Letter signed by National Alliance for ME to HHS stating their support for the letter of the 35 experts.
‘Heed our respected experts and follow their lead! THEY are the hands-on, lifelong, highly regarded specialists with this disease; government officials and agencies do not have this wealth of experience. The signatories state that they stand ready to work with you - that is an honor and deserves more respect than our taxpayer-funded agencies have shown.’
September 26, 2013
PANDORA issued their position paper regarding the contract with IOM.
‘Simply, our position is as follows:
• Only ME/CFS experts have the experience and knowledge to define the disease.
• A consensus of experts and the medical professional community at large on how to diagnose the disease is greatly needed.
• The 2003 ME/CFS Clinical Working Case Definition, Diagnostic and Treatment Protocols (also
called the “Canadian Consensus Criteria” or “CCC”) is far superior to the more commonly used
1994 International Case Definition (Fukuda) or Oxford definition, but the current state of
scientific knowledge has shown a clinical definition with biomarkers and treatment subgroups is
now possible and needed.
• A definition that tells how to distinguish those with severe functional limitations is needed.
• Any effort to improve the definition must include replacing the “CFS” moniker.
• At least three different definitions are needed: a clinical definition, a more narrow research
definition, and a clinical pediatric definition, and these should be developed together from the
same initiative.’
September 28, 2013
Dr. Lily Chu’s letterto HHS asking to cancel the IOM contract.
‘This history is largely why I and other patients, now joined by expert clinicians and researchers, experience a collective shudder of fear and horror when they hear DHHS plans to a) construct a clinical case definition employing professionals unfamiliar with ME/CFS, b) separate from a research case definition, c) at several separate meetings no less. ME/CFS’s past is filled with examples of ineffective and harmful ideas and treatments visited upon patients without listening to their stories nor to those of the clinicians taking care of them. Confusion and harm has already been incurred by applying research based on one definition (e.g. Oxford-based PACE trials) to patients diagnosed with another definition (Fukuda) and by employing a research case definition (Fukuda), without a solid clinical grounding, that focuses on the wrong symptom. Why make that same mistake again?’
September 30, 2013
Dr. Lucinda Bateman, who was one of the 35 signers of the experts’ letter to HHS, issued a statementre-thinking her position.
‘3. The Statement of Work [everyone should read it] appears thoughtful and informed—much better than I had expected based on early concerns about the contract. We can remain actively engaged in calling for a committee that is empowered, experienced and scientifically grounded. We can respond to the committee’s results. We can regroup if they fail or fall short.
4. to the best of my knowledge, the contract has been awarded, so we should now do what is in our power to make it as successful as possible. ‘
Jennie Spotila obtained the Statement of Work(SOW) from HHS for their contract with the IOM.
‘This project will enable HHS/NIH to support a study committee to recommend clinical diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). This activity is in support of the Chronic Fatigue Syndrome Advisory Committee (CFSAC), a federal advisory committee that reports to the Secretary through the Assistant Secretary for Health.’
‘Under a task order against the NIH umbrella contract, the Institute of Medicine (IOM) will:
1. Conduct a study to identify the evidence for various diagnostic clinical criteria of ME/CFS
using a process with stakeholder input, including practicing clinicians and patients;
2. Develop evidence-based clinical diagnostic criteria for ME/CFS for use by clinicians, using a
consensus-building methodology;
3. Recommend whether new terminology for ME/CFS should be adopted;
4. Develop an outreach strategy to disseminate the definition nationwide to health professionals. ‘
A repeat letter by the National Alliance of ME to HHS - heed our experts letter.
‘Paragraph 2: You state, “A group of voting and non-voting members of the committee participated in the development of the Statement of Work.” Please produce for us the Statement of Work in its entirety, with names, departments, and who contributed what. Non-voting members of the CFSAC should not be included in defining a disease when they do not examine patients or participate in direct patient study. Unscientific. ‘
October 2, 2013
The CFIDS Association issued a statement of their standing on the issue of the contract with
IOM.
‘We all acknowledge the need for evidence based, broadly accepted clinical and research tools that can accurately include or identify all subsets of the broad heterogeneous group that presents under any case definition of ME/CFS. We feel that the Canadian Clinical Consensus* can be optimized as a clinical case definition by applying a standardized methodology of execution, through validation of criteria, and a nationwide dissemination to health professionals.
In order to move forward more swiftly and to achieve better understanding, diagnosis and treatments, we must broaden support for ME/CFS research at all levels.’
‘Now that the full statement of work is available from HHS, the Association is reviewing it to see how all stakeholders can best engage in the process. Together we must work to ensure the best experts are placed on the committee and that the patients have as strong a voice as possible. Together we must respond to the committee’s results, promising strong opposition if they fall short. Our shared goal is to ensure the IOM contract results in a quality clinical case definition that can be used nationwide and will move things forward.’
October 8, 2013
The CFIDS Association issued a “clarification” statement.
‘First, I sent an email to my colleagues who signed the letter to Secretary Sebelius asking to adopt the Canadian Consensus Criteria and cancel the IOM contract. There is speculation that I asked them to rescind their signature. I did not ask anyone to rescind their signature or change their mind. I reached out to those I had email addresses for (29 signatories), asking if they still agreed with the letter given the IOM contract was awarded and more information on the scope of work had been provided. I heard from about half of the signatories. Several stood by their signature indicating the money for the contract should go to research. Others didn’t feel an IOM committee would do a good job. And yet others were hopeful that the IOM contract would be productive and effective. It was important to hear this because we value their expertise and opinions. Many look to us for insight, opinion and information. We try to understand all sides of an issue so we can provide the most balanced information and make the most informed decisions.’
IOM invites some ME/CFS groups to send a list of potential nominees, with a 3 day deadline. (later extended for a week)
October 14, 2013
PANDORA issued their new position on the IOM contract.
‘We realized that if we do not work to put our experts on the committee, we will create the very thing we are against: non-ME/CFS experts deciding how to define the disease. It will be us to blame then and not the IOM or the government.
Therefore, we decided to turn in a list of expert nominations. And we have since learned of at least four other organizations that turned in nominations. Does this mean we support the IOM contract? No. We are eager to assist the experts if they independently or through a medical professional organization take the lead in solving the lack of definition consensus in the expert and medical community at large through a workshop, a study or other means. However, we have been told this option is not available and just demanding it without a study or workshop has not and will not work.’
October 16, 2013
The National CFIDS Foundation issued a stance against the IOM contract.
‘The NCF is against the Institute of Medicine and their "efforts". Our government has already proven more than capable of ignoring scientific work with Gulf War Illness and given it a much more obscure name by the IOM just as a CDC committee did with ME decades ago and whose committee members became authors of the first Holmes criteria.’
October 18. 2013
Dr. Ellie Stein issues a statement of support of the letter signed by the 35 experts against the IOM contract.
‘ I gave my signature but it somehow didn’t get included on the final copy of the letter. We are calling for HHS to follow our lead by using the CCC as the sole case definition for ME/CFS in all of HHS’s activities related to the disease and strongly urged HHS to abandon its plans to contract the Institute of Medicine who has no knowledge or experience with ME/CFS to develop new clinical diagnostic criteria.’
October 25, 2013
Pandora sends letter to Dr. Wanda Jones for answers to some questions.
'1. Can the IoM contract be stopped? If not, why not?
2. Can the Dept. of HHS endorse the 2003 CCC as patients, many ME/CFS experts and the CFSAC want? If not, why not?
3. Why did the Dept. of HHS not follow the CFSAC recommendation to host a workshop of ME/CFS experts and instead contracted for the IoM to do a study?
4. Considering that the Gulf War illness treatment study came back with requiring only two symptoms for diagnosis and that the NICE Guidelines are one of the things considered in the ME/CFS IoM study, what guarantee do the patients and ME/CFS experts have that something more broad, and therefore more harmful, than Fukuda won't be the result?'
October 26, 2013
The experts send a new letter to HHS to adopt the CCC now and cancel the IOM contract with 16 new signatures.
'We strongly urge the Department of Health and Human Services (HHS) to follow our lead by
using the CCC as the sole case definition for ME/CFS in all of the Department’s activities
related to this disease.
In addition, we strongly urge you to abandon efforts to reach out to groups such as the Institute
of Medicine (IOM) that lack the needed expertise to develop “clinical diagnostic criteria” for
ME/CFS. Since the expert ME/CFS scientific and medical community has developed and
adopted a case definition for research and clinical purposes, this effort is unnecessary and
would waste scarce taxpayer funds that would be much better directed toward funding research
on this disease. Worse, this effort threatens to move ME/CFS science backward by engaging
non-experts in the development of a case definition for a complex disease about which they are
not knowledgeable.'
October 27, 2013
The National Alliance of M.E. publishes article - HHS/IOM Contract Can Be Terminated
“It is in the government’s interest” to not disenfranchise 50 (and counting) of the best medical experts in this field. THEY are the authorities on ME/CFS; they have “strongly urged” HHS to “ABANDON EFFORTS TO REACH OUT TO GROUPS SUCH AS THE INSTITUTE OF MEDICINE (IOM) THAT LACK THE NEEDED EXPERTISE TO DEVELOP ‘CLINICAL DIAGNOSTIC CRITERIA’ FOR ME/CFS.” It is NOT in the government’s interest to disregard this wealth of knowledge.'
The Institute of Medicine (IoM) unveils their project page for the study to define ME/CFS - They include a link for e-mail sign up.
October 28
66 Advocates sign a letter to Secretary Sebelius in support of the 50 experts - http://thoughtsaboutme.com/2013/10/...cretary-sebelius-in-support-of-their-experts/
November 4, 2013
Jennie Spotila on her blog OccupyCFS, explains the stages of the IOM process.
What We Need to Do
It is important to note that efforts to cancel this study continue. More experts signed on to the letter to HHS on October 26th, increasing the number of signatories to 50. On October 28th,more than 60 advocates sent a letter to HHS in support of those experts. Petitions and letter campaigns continue. In addition, PANDORA submitted a number of questions to Dr. Wanda Jones at HHS, and were told a response would be prepared. Controversy abounds within the advocacy community, and I’ll have more on that soon. But for those who want to follow the IOM study progress and contribute to the process, I suggest the following:
November 9
105 additional advocates sign a letter to HHS in support of the experts' letter - http://thoughtsaboutme.com/2013/11/09/overwhelming-growing-support-of-me-experts-by-advocates-in-opposition-to-iom-contract-advocates-open-letter-re-sent-with-additional-signatures/
November 11
Call for Investigation by the Inspector General of the IOM's Conflict of Interest With Respect to ME/CFS - http://thoughtsaboutme.com/2013/11/...s-conflict-of-interest-with-respect-to-mecfs/
In this case, the IOM has clearly and unabashedly demonstrated its bias relating to the ME/CFS diagnostic criteria. It did so just earlier this year in its report on Chronic Multisymptom Illness (Gulf War and Health: Treatment for Chronic Multisymptom Illness (“CMI Report”)).
November 12
Secretary Sebelius sends a letter in reply to the experts open letter.
'HHS does not generally develop diagnostic criteria for disease conditions, an IOM study was determined to be the most appropriate response to the recommendation made by the Chronic Fatigue Syndrome Advisory Committee (CFSAC) during its October 2012 meeting.'
November 15
HHS sends out a Q & A through the CFSAC listserv - http://solvecfs.org/cfsac-responds-to-questions-concering-the-contract-with-the-iom/
December 3
The IOM provides the list of 15 provisional panel members for their study defining ME/CFS. There is a 20 day window for public comments.
To be updated weekly
October 2012
CFSAC’s voting members issued a recommendationto the secretary of HHS stating:
‘that you will promptly convene (by 12/31/12 or as soon as possible thereafter) at least one stakeholders’ (ME/CFS experts, patients, advocates) workshop in consultation with CFSAC members to reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian Consensus Definition for discussion purposes. (10/12)’
August 27, 2013
HHS announces a sole solicitationwith the Institute of Medicine (OMI) for a study on diagnostic criteria for ME/CFS.
'Clinicians and medical professionals disagree on many aspects of ME/CFS, ranging from frank disbelief in the illness to confusion about the application of clinical diagnostic criteria. In collaboration with CFSAC ex officio agencies, OASH will request that the IOM develop consensus clinical diagnostic criteria for this disorder. A widely accepted clinical definition and a clear distinction from clinical trials and research case definitions would aid in advancing clinical care, drug development, and basic and translational research for ME/CFS. This study would also demonstrate HHS' commitment and aggressive pursuit of solutions to this poorly-understood and disabling condition.'
September 4, 2013
HHS announces; “Because of all of the concern from the public surrounding this potential sole source requisition, we have decided to discontinue this request.”September 20, 2013
The National Alliance for Myalgic Encephalomyelitis sent a letter to HHS showing their opposition to their solicitation of the contract with IOM.
‘In defiance of President Obama’s Open Government Initiative, HHS is pursuing the IOM
contract unilaterally and with disregard for the overwhelming opposition to it from the ME
community and advice from HHS’s own “Chronic Fatigue Syndrome” Advisory Committee
(CFSAC). ‘
September 23, 2013
HHS, through the CFSAC listserv sends an announcement of their contract with IOM to start their study on clinical diagnostic criteria for ME/CFS.
‘We are pleased to announce that the Institute of Medicine (IOM) will begin conducting a study on Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome this month. This study grew out of the 2012 CFSAC recommendation to the Secretary to convene a workshop to “reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS.” Because the use of and audience for case definitions for research and clinical care are very different, HHS decided that separate processes were needed to develop them. The NIH is convening an Evidence-based
Methodology Workshop process that will consider case definitions appropriate for ME/CFS research and the IOM will address the clinical diagnostic portion of the recommendation.’
The same night a lettersigned by 35 ME/CFS expert clinicians and experts was sent to HHS urging them to follow their lead and adopt the CCC and to cancel the IOM contract.
‘We strongly urge the Department of Health and Human Services (HHS) to follow our lead by
using the CCC as the sole case definition for ME/CFS in all of the Department’s activities
related to this disease.
In addition, we strongly urge you to abandon efforts to reach out to groups such as the Institute
of Medicine (IOM) that lack the needed expertise to develop “clinical diagnostic criteria” for
ME/CFS. Since the expert ME/CFS scientific and medical community has developed and
adopted a case definition for research and clinical purposes, this effort is unnecessary and
would waste scarce taxpayer funds that would be much better directed toward funding research
on this disease. Worse, this effort threatens to move ME/CFS science backward by engaging
non-experts in the development of a case definition for a complex disease about which they are
not knowledgeable.’
September 25, 2013
A Letter signed by National Alliance for ME to HHS stating their support for the letter of the 35 experts.
‘Heed our respected experts and follow their lead! THEY are the hands-on, lifelong, highly regarded specialists with this disease; government officials and agencies do not have this wealth of experience. The signatories state that they stand ready to work with you - that is an honor and deserves more respect than our taxpayer-funded agencies have shown.’
September 26, 2013
PANDORA issued their position paper regarding the contract with IOM.
‘Simply, our position is as follows:
• Only ME/CFS experts have the experience and knowledge to define the disease.
• A consensus of experts and the medical professional community at large on how to diagnose the disease is greatly needed.
• The 2003 ME/CFS Clinical Working Case Definition, Diagnostic and Treatment Protocols (also
called the “Canadian Consensus Criteria” or “CCC”) is far superior to the more commonly used
1994 International Case Definition (Fukuda) or Oxford definition, but the current state of
scientific knowledge has shown a clinical definition with biomarkers and treatment subgroups is
now possible and needed.
• A definition that tells how to distinguish those with severe functional limitations is needed.
• Any effort to improve the definition must include replacing the “CFS” moniker.
• At least three different definitions are needed: a clinical definition, a more narrow research
definition, and a clinical pediatric definition, and these should be developed together from the
same initiative.’
September 28, 2013
Dr. Lily Chu’s letterto HHS asking to cancel the IOM contract.
‘This history is largely why I and other patients, now joined by expert clinicians and researchers, experience a collective shudder of fear and horror when they hear DHHS plans to a) construct a clinical case definition employing professionals unfamiliar with ME/CFS, b) separate from a research case definition, c) at several separate meetings no less. ME/CFS’s past is filled with examples of ineffective and harmful ideas and treatments visited upon patients without listening to their stories nor to those of the clinicians taking care of them. Confusion and harm has already been incurred by applying research based on one definition (e.g. Oxford-based PACE trials) to patients diagnosed with another definition (Fukuda) and by employing a research case definition (Fukuda), without a solid clinical grounding, that focuses on the wrong symptom. Why make that same mistake again?’
September 30, 2013
Dr. Lucinda Bateman, who was one of the 35 signers of the experts’ letter to HHS, issued a statementre-thinking her position.
‘3. The Statement of Work [everyone should read it] appears thoughtful and informed—much better than I had expected based on early concerns about the contract. We can remain actively engaged in calling for a committee that is empowered, experienced and scientifically grounded. We can respond to the committee’s results. We can regroup if they fail or fall short.
4. to the best of my knowledge, the contract has been awarded, so we should now do what is in our power to make it as successful as possible. ‘
Jennie Spotila obtained the Statement of Work(SOW) from HHS for their contract with the IOM.
‘This project will enable HHS/NIH to support a study committee to recommend clinical diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). This activity is in support of the Chronic Fatigue Syndrome Advisory Committee (CFSAC), a federal advisory committee that reports to the Secretary through the Assistant Secretary for Health.’
‘Under a task order against the NIH umbrella contract, the Institute of Medicine (IOM) will:
1. Conduct a study to identify the evidence for various diagnostic clinical criteria of ME/CFS
using a process with stakeholder input, including practicing clinicians and patients;
2. Develop evidence-based clinical diagnostic criteria for ME/CFS for use by clinicians, using a
consensus-building methodology;
3. Recommend whether new terminology for ME/CFS should be adopted;
4. Develop an outreach strategy to disseminate the definition nationwide to health professionals. ‘
A repeat letter by the National Alliance of ME to HHS - heed our experts letter.
‘Paragraph 2: You state, “A group of voting and non-voting members of the committee participated in the development of the Statement of Work.” Please produce for us the Statement of Work in its entirety, with names, departments, and who contributed what. Non-voting members of the CFSAC should not be included in defining a disease when they do not examine patients or participate in direct patient study. Unscientific. ‘
October 2, 2013
The CFIDS Association issued a statement of their standing on the issue of the contract with
IOM.
‘We all acknowledge the need for evidence based, broadly accepted clinical and research tools that can accurately include or identify all subsets of the broad heterogeneous group that presents under any case definition of ME/CFS. We feel that the Canadian Clinical Consensus* can be optimized as a clinical case definition by applying a standardized methodology of execution, through validation of criteria, and a nationwide dissemination to health professionals.
In order to move forward more swiftly and to achieve better understanding, diagnosis and treatments, we must broaden support for ME/CFS research at all levels.’
‘Now that the full statement of work is available from HHS, the Association is reviewing it to see how all stakeholders can best engage in the process. Together we must work to ensure the best experts are placed on the committee and that the patients have as strong a voice as possible. Together we must respond to the committee’s results, promising strong opposition if they fall short. Our shared goal is to ensure the IOM contract results in a quality clinical case definition that can be used nationwide and will move things forward.’
October 8, 2013
The CFIDS Association issued a “clarification” statement.
‘First, I sent an email to my colleagues who signed the letter to Secretary Sebelius asking to adopt the Canadian Consensus Criteria and cancel the IOM contract. There is speculation that I asked them to rescind their signature. I did not ask anyone to rescind their signature or change their mind. I reached out to those I had email addresses for (29 signatories), asking if they still agreed with the letter given the IOM contract was awarded and more information on the scope of work had been provided. I heard from about half of the signatories. Several stood by their signature indicating the money for the contract should go to research. Others didn’t feel an IOM committee would do a good job. And yet others were hopeful that the IOM contract would be productive and effective. It was important to hear this because we value their expertise and opinions. Many look to us for insight, opinion and information. We try to understand all sides of an issue so we can provide the most balanced information and make the most informed decisions.’
IOM invites some ME/CFS groups to send a list of potential nominees, with a 3 day deadline. (later extended for a week)
October 14, 2013
PANDORA issued their new position on the IOM contract.
‘We realized that if we do not work to put our experts on the committee, we will create the very thing we are against: non-ME/CFS experts deciding how to define the disease. It will be us to blame then and not the IOM or the government.
Therefore, we decided to turn in a list of expert nominations. And we have since learned of at least four other organizations that turned in nominations. Does this mean we support the IOM contract? No. We are eager to assist the experts if they independently or through a medical professional organization take the lead in solving the lack of definition consensus in the expert and medical community at large through a workshop, a study or other means. However, we have been told this option is not available and just demanding it without a study or workshop has not and will not work.’
October 16, 2013
The National CFIDS Foundation issued a stance against the IOM contract.
‘The NCF is against the Institute of Medicine and their "efforts". Our government has already proven more than capable of ignoring scientific work with Gulf War Illness and given it a much more obscure name by the IOM just as a CDC committee did with ME decades ago and whose committee members became authors of the first Holmes criteria.’
October 18. 2013
Dr. Ellie Stein issues a statement of support of the letter signed by the 35 experts against the IOM contract.
‘ I gave my signature but it somehow didn’t get included on the final copy of the letter. We are calling for HHS to follow our lead by using the CCC as the sole case definition for ME/CFS in all of HHS’s activities related to the disease and strongly urged HHS to abandon its plans to contract the Institute of Medicine who has no knowledge or experience with ME/CFS to develop new clinical diagnostic criteria.’
October 25, 2013
Pandora sends letter to Dr. Wanda Jones for answers to some questions.
'1. Can the IoM contract be stopped? If not, why not?
2. Can the Dept. of HHS endorse the 2003 CCC as patients, many ME/CFS experts and the CFSAC want? If not, why not?
3. Why did the Dept. of HHS not follow the CFSAC recommendation to host a workshop of ME/CFS experts and instead contracted for the IoM to do a study?
4. Considering that the Gulf War illness treatment study came back with requiring only two symptoms for diagnosis and that the NICE Guidelines are one of the things considered in the ME/CFS IoM study, what guarantee do the patients and ME/CFS experts have that something more broad, and therefore more harmful, than Fukuda won't be the result?'
October 26, 2013
The experts send a new letter to HHS to adopt the CCC now and cancel the IOM contract with 16 new signatures.
'We strongly urge the Department of Health and Human Services (HHS) to follow our lead by
using the CCC as the sole case definition for ME/CFS in all of the Department’s activities
related to this disease.
In addition, we strongly urge you to abandon efforts to reach out to groups such as the Institute
of Medicine (IOM) that lack the needed expertise to develop “clinical diagnostic criteria” for
ME/CFS. Since the expert ME/CFS scientific and medical community has developed and
adopted a case definition for research and clinical purposes, this effort is unnecessary and
would waste scarce taxpayer funds that would be much better directed toward funding research
on this disease. Worse, this effort threatens to move ME/CFS science backward by engaging
non-experts in the development of a case definition for a complex disease about which they are
not knowledgeable.'
October 27, 2013
The National Alliance of M.E. publishes article - HHS/IOM Contract Can Be Terminated
“It is in the government’s interest” to not disenfranchise 50 (and counting) of the best medical experts in this field. THEY are the authorities on ME/CFS; they have “strongly urged” HHS to “ABANDON EFFORTS TO REACH OUT TO GROUPS SUCH AS THE INSTITUTE OF MEDICINE (IOM) THAT LACK THE NEEDED EXPERTISE TO DEVELOP ‘CLINICAL DIAGNOSTIC CRITERIA’ FOR ME/CFS.” It is NOT in the government’s interest to disregard this wealth of knowledge.'
The Institute of Medicine (IoM) unveils their project page for the study to define ME/CFS - They include a link for e-mail sign up.
October 28
66 Advocates sign a letter to Secretary Sebelius in support of the 50 experts - http://thoughtsaboutme.com/2013/10/...cretary-sebelius-in-support-of-their-experts/
November 4, 2013
Jennie Spotila on her blog OccupyCFS, explains the stages of the IOM process.
What We Need to Do
It is important to note that efforts to cancel this study continue. More experts signed on to the letter to HHS on October 26th, increasing the number of signatories to 50. On October 28th,more than 60 advocates sent a letter to HHS in support of those experts. Petitions and letter campaigns continue. In addition, PANDORA submitted a number of questions to Dr. Wanda Jones at HHS, and were told a response would be prepared. Controversy abounds within the advocacy community, and I’ll have more on that soon. But for those who want to follow the IOM study progress and contribute to the process, I suggest the following:
- Be ready for the provisional slate announcement at the end of November/beginning of December
- Submit comments on the provisional slate during the twenty day comment period
- Begin drafting written submissions to the committee
November 9
105 additional advocates sign a letter to HHS in support of the experts' letter - http://thoughtsaboutme.com/2013/11/09/overwhelming-growing-support-of-me-experts-by-advocates-in-opposition-to-iom-contract-advocates-open-letter-re-sent-with-additional-signatures/
November 11
Call for Investigation by the Inspector General of the IOM's Conflict of Interest With Respect to ME/CFS - http://thoughtsaboutme.com/2013/11/...s-conflict-of-interest-with-respect-to-mecfs/
In this case, the IOM has clearly and unabashedly demonstrated its bias relating to the ME/CFS diagnostic criteria. It did so just earlier this year in its report on Chronic Multisymptom Illness (Gulf War and Health: Treatment for Chronic Multisymptom Illness (“CMI Report”)).
November 12
Secretary Sebelius sends a letter in reply to the experts open letter.
'HHS does not generally develop diagnostic criteria for disease conditions, an IOM study was determined to be the most appropriate response to the recommendation made by the Chronic Fatigue Syndrome Advisory Committee (CFSAC) during its October 2012 meeting.'
November 15
HHS sends out a Q & A through the CFSAC listserv - http://solvecfs.org/cfsac-responds-to-questions-concering-the-contract-with-the-iom/
December 3
The IOM provides the list of 15 provisional panel members for their study defining ME/CFS. There is a 20 day window for public comments.
To be updated weekly
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