I agree but everyone does this with the SF-36.
The P2P Draft report is out
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I agree but everyone does this with the SF-36.
alex3619
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Clinically this is potentially valid. For a research cohort it shouldn't matter .. we want as clean and homogeneous group as possible.
alex3619
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Which is part of the problem.
You know... I wish that these ME/CFS "experts" that always talk about how NK cell function is a marker for this disease would just get together and publish a review paper stating so. They have been saying this for years and they even use the marker clinically in their practices to track disease activity and response to treatment and yet every damn time one of them orders this test I have to fight with my insurance to get it paid for because there is supposedly "no indication".
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alex3619
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@acer2000, I strongly suspect that most of the time they want to move forward they cannot get funding. No funding, no research.
There are many holes in the research. However we are an extremely low priority for funding, and even high quality study proposals get rejected. Typical government funding on ME and CFS could be gobbled up in a couple of good studies, if not one good study. One well funded study a year is not enough.
Our researchers have to continually make choices about what tests to run, cohort sizes, etc. I suspect frequent rejections have led them to stop applying for larger and better studies. I wonder if anyone who knows about failed grant requests might comment on this?
This is not entirely unique to ME and CFS though. Many diseases face this. One of the issues causing rising health care costs is an historical deficit in researching chronic disease, the kind that often does not kill you quickly. There is a huge need to address this, if not for the patient's wellbeing, then for the economic consequences. Bandaid biopsychosocially justified denial of payment only moves the burden around, while solving nothing.
Our researchers have been complaining about many of the issues for years, and so have advocates. Yet no solution has ever been found - this takes political will, and its clearly lacking.
This is yet another proposal for a way forward. Its not the first. It might not be the last. If NIH or other bodies do not act, then its not much more than a fancy document and padding on some resumes.
One thing we should consider though is that this gives us even more ammunition to advocate for more funding, and for political action to address our issues.
There are many holes in the research. However we are an extremely low priority for funding, and even high quality study proposals get rejected. Typical government funding on ME and CFS could be gobbled up in a couple of good studies, if not one good study. One well funded study a year is not enough.
Our researchers have to continually make choices about what tests to run, cohort sizes, etc. I suspect frequent rejections have led them to stop applying for larger and better studies. I wonder if anyone who knows about failed grant requests might comment on this?
This is not entirely unique to ME and CFS though. Many diseases face this. One of the issues causing rising health care costs is an historical deficit in researching chronic disease, the kind that often does not kill you quickly. There is a huge need to address this, if not for the patient's wellbeing, then for the economic consequences. Bandaid biopsychosocially justified denial of payment only moves the burden around, while solving nothing.
Our researchers have been complaining about many of the issues for years, and so have advocates. Yet no solution has ever been found - this takes political will, and its clearly lacking.
This is yet another proposal for a way forward. Its not the first. It might not be the last. If NIH or other bodies do not act, then its not much more than a fancy document and padding on some resumes.
One thing we should consider though is that this gives us even more ammunition to advocate for more funding, and for political action to address our issues.
Hope123
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I have not read all the comments in the thread but here are some of my impressions of the Executive Summary draft. Since this is the Exec Summary, it makes me wonder where the rest of the draft is since usually the Summary is an overview but does not contain the details. If someone has access to the rest of the draft, please post it.
Also, feel free to use/ steal/ send in any of my ideas to the Panel if they resonate with you.
To me, the document didn't really sufficiently answer the questions that were posed. Yes, it could have been worse but it also could have been better. The problem is 1) the Panel were not experienced with the illness and thus could not be expected to be on top of things and 2) the AHRQ review/ presentations excluded studies/ pieces of evidence by the way the review/ talks were framed. Some of the statements sounded pretty generic to me and could have been drawn from documents concerning other conditions (note I am not saying they were copied from other docs, just that it was generic).
Now, I don't want to be entirely negative so let me first point out what I like:
1) Discarding of Oxford criteria -- good riddance to bad garbage; irrespective of how clinicians use criteria, the problem is that they are used in trials so a good case definition is important
2) Need for registry/ Biobank/ collaborative network -- These were suggested by the US CFS Advisory Committee in Spring 2014 and was categorically denied by Dr. Collins in his June response to CFSAC. Collins' response was basically that there were only limited funds for ME/CFS research and that giving money to fund a registry/ Biobank would take away funds for other ME/CFS research. How about increasing the $$ given to ME/CFS?
What needs to be done is to re-iterate that here is another group suggesting this and why isn't it being funded? As an American, I would also hope that NIH releases funds for a US Biobank; NIH gave the UK $1.5 million for a ME/CFS Biobank last year but does that Biobank include ANY US patients? If not, we need a separate one established here; I don't mind giving money to research abroad but let's make sure we take care of our own citizens also.
http://www.hhs.gov/advcomcfs/recommendations/06142014.html
http://www.hhs.gov/advcomcfs/recommendations/hhs-cfsac-recommendations-response.pdf
http://blogs.lshtm.ac.uk/news/2013/06/28/uk-mecfs-biobank-project-awarded-1-million-grant/
3) Emphasis on patient participation in research -- There is a movement within medicine to incorporate more patient perspective into research and clinical care. This is a good thing as what patients/ families consider to be relevant is very different from what clinicians/ researchers and the former is just as important as the latter. and especially so for ME/CFS. Line 166 says the "symptoms patients consider important are not in the scientific literature" but I don't think that is true. Back to the other point: there are published qualitative studies of what patients considered important -- it's just that the review did not include them.
Problems with the report:
1) Some recommendations made have already been done but without follow-up, funding, or "teeth", action has not resulted and thus no progress. How much did this Panel know about what had already been done in the past?
The Panel asks in multiple areas that a single case definition be agreed upon and, in Lines 202-203, that stakeholders be convened "to reach consensus on the definition." The problem is not that multiple case definitions exist -- in fact, the overwhelming majority of studies have used on definition, Fukuda -- but that Fukuda is a lousy case definition. (Line 50 talks about how Fukuda has "163 symptoms" but this is wrong; what Dr. Nacul said was 163 COMBINATIONS of symptoms could be generated from the major and minor symptoms of Fukuda. And that in analyzing all patients as one group, researchers are assuming they're all the same despite the heterogeneity.)
Also, CFSAC's original 2012 recommendation was that a research case definition be constructed and agreed upon and the original intent of this workshop was to do that yet at the Jan IOM meeting, NIH changed the goals. So now instead of actually achieving a case definition, the Panel is asking AGAIN that another workshop be convened?
Talk about kicking the can down the road! At least the gov't is creating or maintaining jobs!?
("CFSAC recommends that you will promptly convene (by 12/31/12 or as soon as possible thereafter) at least one stakeholders’ (Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (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." http://www.hhs.gov/advcomcfs/recommendations/10032012.html)
Similarly, the Panel asked for a FDA workshop (Line 365), yet the FDA just held one (and it was useful) in 2013. If another one is to be held, the goals need to be clearer. Otherwise, it's just more talk, no action.
2) Inclusion of Oxford studies in the treatment section: As has been already noted by other posters, why include these studies in treatment when the Panel itself says Oxford should be thrown out as a research case definition?
They should do a re-analysis of the treatment studies without the trials using Oxford and then present the data with and without those trials. This is called a sensitivity analysis and commonly done to see what happens in different contingency situations.
3) Holy homeopathy, Batman! - Line 281: Why are we invoking homeopathy for ME/CFS when in the US, it is discredited as a legitimate treatment for almost all medical conditions? It's not going to help researchers or clinicians view this as a "real" illness. Do they think ME/CFS patients are stupid enough that we can think ourselves better? This is contradictory to the letter and spirit of the rest of the report and should be removed. Here's NIH's take on homeopathy via their Alternative/ Complementary Medicine institute:
"There is little evidence to support homeopathy as an effective treatment for any specific condition."
(http://nccam.nih.gov/health/homeopathy)
4) "No agreement from the research community on what needs to be studied" - Line 34: First, this is not the only field where researchers do not wholly agree on what needs to be studied. Second, there are documents where researchers HAVE delineated what they think are important to study. It's again the Panel not being exposed to the field enough and, with limited time, hearing from multiple presenters that aren't primarily researching ME/CFS.
The NIH's own 2011 State of the Knowledge Conference Report talks about areas, gaps, and opportunities but it was likely not shared with the Panel and no funding for research followed this report:
http://orwh.od.nih.gov/research/me-cfs/pdfs/ORWH_SKW_Report.pdf
Secondly, we have the CFSAC Research Working Group's recommendations as well as numerous suggestions over the years:
http://www.hhs.gov/advcomcfs/recommendations/06142014.html
http://www.hhs.gov/advcomcfs/recommendations/
Finally, the IACFS/ME 2014 Scientific Conference Abstracts gives some ideas about direction as well:
http://www.iacfsme.org/DesktopModules/DigitalDownload/2014Syllabus25.pdf
5) Line 53-53 - "no data on minorities" -- again, there aren't a lot but there is some data on minorities which was presented at the meeting so not sure why they would say this. The data shows they may be at higher risk or getting ME/CFS and having more severe symptoms. In addition, the Panelists should consider WHY there is so little data, e.g. -- the "yuppie flu" perception leads clinicians to decide that ME/CFS is not an illness of minorities, the poor, etc.; since Fukuda is viewed by many clinicians as a diagnosis of exclusion, most minorities do not have the $$ or access of care enough to get tons of testing and a diagnosis, etc.
6) Lines 87 and Lines 373 -- "patient education" -- These lines are condescending. While I as a clinician always advocate for better patient education and indeed have educated my patients on how to prepare for the short visits that a busy clinic schedule can dictate, the lines here about "patient education" make it sound like patients are not trying the hardest and darnedest to communicate already and that the problems fall mostly at the feet of clinicians. ME/CFS patients are always being held to standards patients of other illnesses are not held to. To the Panelists: would you have these same lines apply to patients with Parkinson's, HIV, MS, or RA? If not, why use them for ME/CFS patients?
7) Line 143 -- "little understanding of inciting events" -- There are lots of studies showing that up to 80% of patients recall an infectious onset in addition to the prospective studies showing this. While some parts of the doc talk about infections as precipitants, I'm not sure why they include this line here. It may be because the systematic review did not include these studies.
8) Orthostatic intolerance -- I agree with prior commenters that this should be considered as a key/ common symptom in any definition constructed. They AHRQ Systematic Review also points this out.
9) GET/ CBT -- The Systematic Report was stronger on this than the Panel draft. I'm not sure the Panel understands the harms of GET/CBT as well.
Here is a published study from 2005 of GET/ CBT in chronically fatigued patients; the best predictor of a poor outcome was fitting the Fukuda criteria:
http://bjp.rcpsych.org/content/186/4/350.full
I have a few other points but this is long and I am worn out!
Also, feel free to use/ steal/ send in any of my ideas to the Panel if they resonate with you.
To me, the document didn't really sufficiently answer the questions that were posed. Yes, it could have been worse but it also could have been better. The problem is 1) the Panel were not experienced with the illness and thus could not be expected to be on top of things and 2) the AHRQ review/ presentations excluded studies/ pieces of evidence by the way the review/ talks were framed. Some of the statements sounded pretty generic to me and could have been drawn from documents concerning other conditions (note I am not saying they were copied from other docs, just that it was generic).
Now, I don't want to be entirely negative so let me first point out what I like:
1) Discarding of Oxford criteria -- good riddance to bad garbage; irrespective of how clinicians use criteria, the problem is that they are used in trials so a good case definition is important
2) Need for registry/ Biobank/ collaborative network -- These were suggested by the US CFS Advisory Committee in Spring 2014 and was categorically denied by Dr. Collins in his June response to CFSAC. Collins' response was basically that there were only limited funds for ME/CFS research and that giving money to fund a registry/ Biobank would take away funds for other ME/CFS research. How about increasing the $$ given to ME/CFS?
What needs to be done is to re-iterate that here is another group suggesting this and why isn't it being funded? As an American, I would also hope that NIH releases funds for a US Biobank; NIH gave the UK $1.5 million for a ME/CFS Biobank last year but does that Biobank include ANY US patients? If not, we need a separate one established here; I don't mind giving money to research abroad but let's make sure we take care of our own citizens also.
http://www.hhs.gov/advcomcfs/recommendations/06142014.html
http://www.hhs.gov/advcomcfs/recommendations/hhs-cfsac-recommendations-response.pdf
http://blogs.lshtm.ac.uk/news/2013/06/28/uk-mecfs-biobank-project-awarded-1-million-grant/
3) Emphasis on patient participation in research -- There is a movement within medicine to incorporate more patient perspective into research and clinical care. This is a good thing as what patients/ families consider to be relevant is very different from what clinicians/ researchers and the former is just as important as the latter. and especially so for ME/CFS. Line 166 says the "symptoms patients consider important are not in the scientific literature" but I don't think that is true. Back to the other point: there are published qualitative studies of what patients considered important -- it's just that the review did not include them.
Problems with the report:
1) Some recommendations made have already been done but without follow-up, funding, or "teeth", action has not resulted and thus no progress. How much did this Panel know about what had already been done in the past?
The Panel asks in multiple areas that a single case definition be agreed upon and, in Lines 202-203, that stakeholders be convened "to reach consensus on the definition." The problem is not that multiple case definitions exist -- in fact, the overwhelming majority of studies have used on definition, Fukuda -- but that Fukuda is a lousy case definition. (Line 50 talks about how Fukuda has "163 symptoms" but this is wrong; what Dr. Nacul said was 163 COMBINATIONS of symptoms could be generated from the major and minor symptoms of Fukuda. And that in analyzing all patients as one group, researchers are assuming they're all the same despite the heterogeneity.)
Also, CFSAC's original 2012 recommendation was that a research case definition be constructed and agreed upon and the original intent of this workshop was to do that yet at the Jan IOM meeting, NIH changed the goals. So now instead of actually achieving a case definition, the Panel is asking AGAIN that another workshop be convened?
Talk about kicking the can down the road! At least the gov't is creating or maintaining jobs!?
("CFSAC recommends that you will promptly convene (by 12/31/12 or as soon as possible thereafter) at least one stakeholders’ (Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (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." http://www.hhs.gov/advcomcfs/recommendations/10032012.html)
Similarly, the Panel asked for a FDA workshop (Line 365), yet the FDA just held one (and it was useful) in 2013. If another one is to be held, the goals need to be clearer. Otherwise, it's just more talk, no action.
2) Inclusion of Oxford studies in the treatment section: As has been already noted by other posters, why include these studies in treatment when the Panel itself says Oxford should be thrown out as a research case definition?
They should do a re-analysis of the treatment studies without the trials using Oxford and then present the data with and without those trials. This is called a sensitivity analysis and commonly done to see what happens in different contingency situations.
3) Holy homeopathy, Batman! - Line 281: Why are we invoking homeopathy for ME/CFS when in the US, it is discredited as a legitimate treatment for almost all medical conditions? It's not going to help researchers or clinicians view this as a "real" illness. Do they think ME/CFS patients are stupid enough that we can think ourselves better? This is contradictory to the letter and spirit of the rest of the report and should be removed. Here's NIH's take on homeopathy via their Alternative/ Complementary Medicine institute:
"There is little evidence to support homeopathy as an effective treatment for any specific condition."
(http://nccam.nih.gov/health/homeopathy)
4) "No agreement from the research community on what needs to be studied" - Line 34: First, this is not the only field where researchers do not wholly agree on what needs to be studied. Second, there are documents where researchers HAVE delineated what they think are important to study. It's again the Panel not being exposed to the field enough and, with limited time, hearing from multiple presenters that aren't primarily researching ME/CFS.
The NIH's own 2011 State of the Knowledge Conference Report talks about areas, gaps, and opportunities but it was likely not shared with the Panel and no funding for research followed this report:
http://orwh.od.nih.gov/research/me-cfs/pdfs/ORWH_SKW_Report.pdf
Secondly, we have the CFSAC Research Working Group's recommendations as well as numerous suggestions over the years:
http://www.hhs.gov/advcomcfs/recommendations/06142014.html
http://www.hhs.gov/advcomcfs/recommendations/
Finally, the IACFS/ME 2014 Scientific Conference Abstracts gives some ideas about direction as well:
http://www.iacfsme.org/DesktopModules/DigitalDownload/2014Syllabus25.pdf
5) Line 53-53 - "no data on minorities" -- again, there aren't a lot but there is some data on minorities which was presented at the meeting so not sure why they would say this. The data shows they may be at higher risk or getting ME/CFS and having more severe symptoms. In addition, the Panelists should consider WHY there is so little data, e.g. -- the "yuppie flu" perception leads clinicians to decide that ME/CFS is not an illness of minorities, the poor, etc.; since Fukuda is viewed by many clinicians as a diagnosis of exclusion, most minorities do not have the $$ or access of care enough to get tons of testing and a diagnosis, etc.
6) Lines 87 and Lines 373 -- "patient education" -- These lines are condescending. While I as a clinician always advocate for better patient education and indeed have educated my patients on how to prepare for the short visits that a busy clinic schedule can dictate, the lines here about "patient education" make it sound like patients are not trying the hardest and darnedest to communicate already and that the problems fall mostly at the feet of clinicians. ME/CFS patients are always being held to standards patients of other illnesses are not held to. To the Panelists: would you have these same lines apply to patients with Parkinson's, HIV, MS, or RA? If not, why use them for ME/CFS patients?
7) Line 143 -- "little understanding of inciting events" -- There are lots of studies showing that up to 80% of patients recall an infectious onset in addition to the prospective studies showing this. While some parts of the doc talk about infections as precipitants, I'm not sure why they include this line here. It may be because the systematic review did not include these studies.
8) Orthostatic intolerance -- I agree with prior commenters that this should be considered as a key/ common symptom in any definition constructed. They AHRQ Systematic Review also points this out.
9) GET/ CBT -- The Systematic Report was stronger on this than the Panel draft. I'm not sure the Panel understands the harms of GET/CBT as well.
Here is a published study from 2005 of GET/ CBT in chronically fatigued patients; the best predictor of a poor outcome was fitting the Fukuda criteria:
http://bjp.rcpsych.org/content/186/4/350.full
I have a few other points but this is long and I am worn out!
jimells
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I very carefully read the document line by line. It took me hours to read it and write up my analysis of it. The way the document is currently written, the psychobabblers can easily pull out what they want. My analysis highlights those sections. Of course, it's probably nearly impossible for a committee to write a report that can't be twisted by the psych lobby.
The biggest problem with the report is the hostile political environment it resides in and the fatally flawed process used to create it. As @Nielk stated:
http://forums.phoenixrising.me/inde...-draft-report-is-out.34480/page-4#post-536645
So instead of adopting CFSAC and expert recommendations, we got P2P, even though their own rules disqualify ME/CFS from this process. Instead of spending a million dollars on a 20 page report, NIH could have simply adopted essentially the same recommendations from their own committee.
I agree with @Jonathan Edwards that most "conspiracies" are just plain old incompetence. This isn't incompetence. The entire process to get to the report is convoluted, compartmentalized, and carefully orchestrated. How can that happen accidentally?
The documents released via the FOIA requests of our advocates clearly shows the hostility of the agencies involved. Even the judge involved in releasing the documents severely criticized how the FOIA requests were handled.
NIH has already rejected some of the recommendations in the report. Are they going to admit their previous rejections were mistakes???
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Hope123
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Even if you cannot do the analysis (and I doubt you will be able to because of poor/ no access to the raw data), you should send in your critique to the panel. All comments are kept and, if I understand correctly, placed in a public file.
I send in public comments not only in the hopes that it will generate change but also for history/ posterity's sake. Someday, and it may not be even far off, some enterprising reporter may dig up those comments and realize what a travesty of the scientific process this all is.
biophile
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Re leaving people out in the cold, don't forget that the ICC has an atypical category:
"Atypical myalgic encephalomyelitis: meets criteria for postexertional neuroimmune exhaustion but has a limit of two
less than required of the remaining criterial symptoms. Pain or sleep disturbance may be absent in rare cases."
"Atypical myalgic encephalomyelitis: meets criteria for postexertional neuroimmune exhaustion but has a limit of two
less than required of the remaining criterial symptoms. Pain or sleep disturbance may be absent in rare cases."
alex3619
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This is the start. I wonder if it was intended that only the executive summary is available for comment and review by the stakeholders? Or is there another draft document coming out?
(my bolding and underlining)
jimells
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While they continue, to this very day, to damage the health of our advocate Jeannette Burmeister by refusing to completely fulfill, and pay for, her FOIA request? The hostility clearly demonstrated in the non-redacted documents makes one wonder what lies behind the curtain.
I view the entire P2P boondoggle as a defensive measure: they're trying to cover their butts and protect the status quo. Now it's possible the report is more favorable to patients than NIH intended and that they are losing control of the message. I don't think there's any rule that conspirators have to be competent.
But in the end, does it matter much what the report says? I don't know of any reason to think NIH will implement anything in the report, after decades of refusing to help us.
Esther12
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re this being the 'draft executive summary' - I was expecting a draft of the full report to be released and was surprised to only have this short document available (I've still not been able to read it all yet mind) - anyone know what's going on here?
jimells
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This has already happened. We have a list of 50 prominent researchers and clinicians that are, and have been, using CCC. As always, the NIH is leading from behind, when it's not trying to be an anchor...
alex3619
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My best guess is the full draft is still being written. By releasing part of it the clock is ticking though. We will not have 30 days from the release of the full report, if indeed it is even released within 30 days.
alex3619
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I think the term is "back seat driver".
Ember
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The Panel's recommendation differs significantly from the above CFSAC 2012 recommendation. In defining disease parameters, federal agencies are specifically to be included; experts and advocates are not: “Assemble a team of stakeholders (e.g., patients, clinicians, researchers, federal agencies) to reach a consensus on the definition and parameters of ME/CFS.”
CFSAC members will not be consulted, and no mention is made of beginning with the CCC.
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snowathlete
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It's been retired by those conducting good science then. But there are still plenty of others conducting bad science based on Fukuda that still causes damage. I see new papers published using Fukuda most weeks probably.
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jimells
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Unfortunately for us, the criteria is a political document. It determines whether or not we can get disability and other social benefits. It is no exaggeration for me to say that if I did not receive disability benefits (after six years!) I would be dead. I would have absolutely nothing, as I was going through bankruptcy and a separate civil suit to seize my home when the benefits were finally approved.
Any illness definition that potentially allows me to be dismissed as "just depressed" is, quite literally, a threat to my life.
jimells
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Why should we be objective? Ask Jeannette Burmeister about HHS objectivity. The Feds even accused her of lying, if I recall correctly.
Gingergrrl
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I have not read the report or this entire thread but was confused that they would list the above four symptoms but not viral, immune, autonomic or cardiac issues?!!! Aren't these a core part of the defintion?