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What Should Phoenix Rising Tell the IOM Committee?

Firestormm

Senior Member
Messages
5,055
Location
Cornwall England
I think I must have missed where Phoenix Rising polled it's members and determined a Phoenix Rising position statement on the IOM contract.

If individuals are opposed to it then say so by all means, but let's not start saying 'we' are all opposed to it, when not everyone is aware of what has been taking place.

I think as a source of information for patients concerns - generally - we might do no better than refer the panel to the FDA Voice of the Patient (if that was it's name - I forget).

The CCC is all ready a document that they said they will review - but I would like to see something said along similar lines to Tania above - as I feel the CCC is probably the most reasonable definition available - BUT - for ME/CFS i.e. as a replacement for Fukuda and CFS.

I would like to say that I see no reason given the current state of knowledge, why we need a different and broader clinical criteria than a research one. So for me - it is CCC for clinical AND for research (although for research I suspect they will need continue to also use Fukuda but along with CCC).

I would also like to see a change of name across the board for all who meet the CCC criteria - to Myalgic Encephalopathy - I would like this review to conclude that CFS should be dropped.

I don't regard CF to be relevant in any way to anyone who meets the CCC and if they can't meet the CCC well then I am sorry but they don't have the disease - at least as far as can be said given the current state of knowledge.

What I think I need to come up with - we need to come up with - is specific examples of things to cite as sources of evidence and I am not sure that anything really has been published that supports a name-change other than to Myalgic Encephalomyelitis which was opposed in previous reviews.

Of course it might not be this time round - might be worth trying again - but I think Encephalopathy is a worthwhile compromise that might stand a better chance of seeing the removal of CFS.

I think some greater recognition of the severities is in order and the different levels of ability to function, impact of disability, would be worth a mention - but again I am confused by the question to which we are being asked to reply.

These are of course my views - if I can find and have time to find any specific sources and can add more things that I would like to see presented I'll add another comment or two.
 

taniaaust1

Senior Member
Messages
13,054
Location
Sth Australia
as slayadragon pointed out. The whole IOM thing is going to be so flawed. Due to studies not being done on the very sick ME patients. .. with a quarter of those with ME bedridden and housebound (or is the statistic for ME there more?). These arent usually included in any studies.

This is why going by studies and not by experts who specialise in this disease is so so bad!!

It is also not about:

depression
deconditioning
childhood abuse
somatization
personality disorder
laziness
malingering
hypochondria
unwellness

Them putting focus on any one symptom I wont like...even if it was a focus on weakness or pain. ME is a complex of symptoms all coming together. I hate how most of my ME/CFS symptoms are ignored as they dont make "their" CDC list when doctors who know nothing about ME think I have CFS. Where is dysautonomia on the symptom list? (one study showed that almost all of us how it and this is measurable)

I even had one doctor try to insist he treat me for muscle pain cause its supposed to be a symptom,.when I dont tend to even get it much (well not anymore, used to severely)

If IOM wants to get things right they need to include testable symptoms we have, things which can be shown on tests (so we can all get away from that psych bullshit we currently often find ourselves under).
 
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taniaaust1

Senior Member
Messages
13,054
Location
Sth Australia
I would also like to see a change of name across the board for all who meet the CCC criteria - to Myalgic Encephalopathy - I would like this review to conclude that CFS should be dropped.

I think I'd be scared to say I want this IOM group to sort out its name. I just dont trust them to do that. I dont want a crappy name like multi symptom illness put onto me. I'd like this illness to a have a PROPER NAME and cant trust that they'd give ME the ME name.. (or maybe even worst they may not separate ME and CFS and end up calling it all just ME.. now that would be an even more nightmare for us).

Anyway..by saying that we want them to sort a name out.. we are risking more trouble esp if they decided to call "CFS" ME too and group it in one lot.
 

taniaaust1

Senior Member
Messages
13,054
Location
Sth Australia
I just started a new petition against non-experts defining (redefining) disease re what is going on with IOM. Please sign if you agree
http://www.thepetitionsite.com/799/278/645/stop-non-experts-from-redefining-diseases/

and while you are at it.. would you mind signing the petition I currently got going on for myself (re my states disability orgs neglect of me and of me not being able to get to the medical appointments I need) http://www.thepetitionsite.com/802/...bled-patients-to-needed-medical-appointments/
thanks
 

Wally

Senior Member
Messages
1,167
@Mark, I asked the following question "@Mark - What specifically did the IOM ask PR to present at this meeting?"

In re-reading the information you posted in the first post in this thread, I realized that you may have already answered my question. Is this what the IOM has asked the PR Forum to speak about?
“What is the most important aspect or information that this committee should consider throughout the course of the study?”

When I read the "quoted" sentence above, I thought this was how you were trying to frame a response to this invitation to speak, but now re-reading your post and Kina's comment I may have misinterpreted what you were saying.

Can you confirm that the sentence quoted above was what the IOM asked PR to make a presentation about? Were any additional instructions or comments provided by the IOM regarding what PR's presentation should or should not contain?

Wally
 

akrasia

Senior Member
Messages
215
@Mark
You covered the terrain very well, and even embodied in the last couple of paragraphs the problem confronting patients of participating in something you deplore.

It's like the joke, "The food in this restaurant stinks and, worse, the portions are too small."

I think the IOM project is not so much to bury us but to manage a policy problem that for whatever reason has taken on some importance for them, enough importance that they found a million to finance it.

It would be a good thing if someone spoke clearly about the fact that so many of us have no confidence in government initiatives regarding m.e., that whatever remarks are delivered in PR's name underline the dismay and fury at how the IOM was organized, the cynicism with which patients were ostensibly "included" in the process, and the confirmation it provided that the concern in all of this is just to rationalize a failed policy. In spite of contending with cognitive difficulties, we still possess a keen sense of ongoing, easily proven, bad faith on the part of the DHHS.
 
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Wally

Senior Member
Messages
1,167
I think I must have missed where Phoenix Rising polled it's members and determined a Phoenix Rising position statement on the IOM contract.

If individuals are opposed to it then say so by all means, but let's not start saying 'we' are all opposed to it, when not everyone is aware of what has been taking place.

I think Firestormm makes a very good point. The use of the words "we" are often thrown around very loosely by some MECFS advocates.

When the MECFS "experts" spoke to the HHS about the IOM Contract and the CCC Definition it was very clear who was speaking. When a follow up letter was sent by a group of patients/advocates in support of the MECFS experts letter it was very clear who these patients/advocates were.

In two petitions, one objecting to the HHS ME/CFS Contract with the IOM (petition started by Patricia Carter*) and one requesting the HHS change the definition and name of the illness (petition started by Mary Dimmock**) it was very clear who the individuals were who signed the petition. While some individuals appeared as an anonymous signature on these petitions to protect their privacy, everyone signing the petition had to identify themselves behind the scenes in order to be recognized as a signer of the petition.

If Phoenix Rising is going to engage in the OMI's invitation to voice the thoughts of its Forum members then I would suggest that a similar mechanism be used as seen in the two petitions noted above. This will serve to provide written evidence of who Phoenix Rising is representing when speaking on this particular topic.

An important advocacy lesson in transparency that a number of other advocacy groups have failed to address/follow. Without an advocacy group holding itself accountable for who they represent, it allows others (such as the HHS and the IOM) to cherry pick who they want to talk to. There is then no accountability on the government's part to show the reason they have selected a particular advocacy group to talk to outside of a public arena.

* Patricia Carter's Petition Opposing the HHS/IOM ME/CFS Contract - https://secure.avaaz.org/en/petition/Stop_the_HHSIOM_contract_and_accept_the_CCC_definition_of_ME/

** Mary Dimmock's Petition Requesting the Definition and Name of the illness be changed - http://www.thepetitionsite.com/255/349/958/fatigue-is-not-a-disease/
 
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Marylib

Senior Member
Messages
1,155
Bob, I am so relieved to see your response. Am not well enough to express myself well, but Lisa Petrison has written a very cogent post expressing my views.
 

Sparrow

Senior Member
Messages
691
Location
Canada
Im very worried aobut that too, this meeting could be the only one we have to try to get throu to people on that panel who arent familar with this illness on how we'd like them to procede going about it and I hate to see our time wasted (when there is a possibility it could still end up going ahead). (remember this is to the IOM panel and not the dept who has contracted them.. the fight to stop IOM needs to not be with IOM but those who are contracting IOM or higher up).

I personally dont think this meeting when we only have minutes to get across what is important to be done if this has to go ahead, is the right place to try to fight the IOM situation. Thou certainly I do want our protest to it mentioned FIRST UP aknowleding and making it clear that we are against the IOM process but I dont think it should take up less then 1min of the time being given ...it probably could be stated in less then 30 seconds (no need to go into names of those opposed as Im sure they know that already) . I'd like to see less then a minute of the time used to push that this whole thing shouldnt even be happening and that we want the CCC which was done by experts to be used.

Yes. This.

This is not the place to spend our allotted time focused on the issues we have with the contract itself. They are not set up for that, that is not the purpose of this meeting, and the people we will be talking to probably can't do much about it anyway. I say please save details about that for the venues where it might have an impact. Make a quick statement that many members of the Phoenix Rising patient community oppose the contract, and then move on.

They are asking us what we want them to know, assuming they really do need to create an illness definition for us. Please, let's answer them.

Phoenix Rising is being given speaking time to be a voice for those of us here who will not be able to express ourselves personally. We're being given the chance to answer their question. Please don't take that chance away from those of us who desperately want to take advantage of it.
 

Firestormm

Senior Member
Messages
5,055
Location
Cornwall England
I think the only written reviews of case definitions I can think of are those from Lenny Jason, so if we do agree the question is asking for specific sources that they might consider, then I would like Jason's papers that review definitions to be taken into account.

I am sure they will anyway.

His recent paper for example was interesting as it again brought into the equation the idea that symptoms individually might be assessed by severity:

http://forums.phoenixrising.me/inde...finition-for-cfs-me-leonard-jason-2013.27006/

Lenny also published a paper in 2012, contrasting existing case definitions at the time, that I sought to draw attention to in relation to the IOM desire to operationalise these definitions:

http://forums.phoenixrising.me/inde...and-compared-it-to-other-criteria-2012.26511/
 

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
I just started a new petition against non-experts defining (redefining) disease re what is going on with IOM. Please sign if you agree
http://www.thepetitionsite.com/799/278/645/stop-non-experts-from-redefining-diseases/

I don't think the IOM can do that. To have only experts means it can't be the IOM doing it. I would be happy for them to not continue with the contract though.

I did sign your personal petition - disabled people need medical transport. It doesn't really exist here either.
 

adin

The old guy now
Messages
115
Yes. This.
They are asking us what we want them to know, assuming they really do need to create an illness definition for us. Please, let's answer them.

Phoenix Rising is being given speaking time to be a voice for those of us here who will not be able to express ourselves personally. We're being given the chance to answer their question. Please don't take that chance away from those of us who desperately want to take advantage of it.


I agree — while we can mention our displeasure with the contracting process in the slides we give the members of the committee, I don't think we need to spend any speaking time on issues that are outside the scope of this committee. We need to focus on telling them what we want them to know while creating/issuing their report. Lets try to stay focused on helping the most of our community we can.

We can protest the contracting process, committee composition, etc at other times and in other forms. This is about getting the best product out of this committee that we can.
 

adin

The old guy now
Messages
115
Just thinking out loud, but do we want to do something unique vs the usual PowerPoint presentation? Since we are such a unique organization, maybe we should try something a little different?

My first thought was a collage or a montage of patients and a single sentence from each? (Like 10 secs?)-We could get 20ish people and still have a minute to open, make one extra point, and close. This way we could get them to see *us* ... I think that we don't want to repeat the same points that everyone else is going to present. I think that letting them see *us*, over and over again might make the emotional impact that might just remind them that this if affecting people in a real significant way and not just hammering out another report/paperwork.

Any other ideas???

Edit : to answer marks original question: The need to know and understand that we are a group of people with a condition that either isn't taken seriously or is mis-treated because medical professionals have "beliefs" instead of guidance, facts, and education — keeping an entire population in a perpetual 'end-stage cancer' state with little care, few treatments, and no hope.
 
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A.B.

Senior Member
Messages
3,780
Challenge the beliefs with facts. Show examples of illnesses that were once thought to be psychological until proper studies revealed that they were physical and that previous treatments based on psychotherapy were nothing but witch doctoring.

One example is peptic ulcers and helicobacter pylori.

I'm not a native English speaker, nor do I live in the US, or I would do some of this work myself.
 
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Firestormm

Senior Member
Messages
5,055
Location
Cornwall England
Is someone willing/able to put together then a more technical and powerful presentation given our resources? I mean we are never short of good ideas but it takes someone to put them all together - unless of course Mark and Adin are volunteering their technical skills. If so that would be excellent :)
 

Ember

Senior Member
Messages
2,115
That was the one area I felt let down with the international ME definition.. they werent basing diagnoses on objective findings).
Here is the Laboratory/Investigative Protocol from the ME Primer:
Laboratory/Investigative Protocol: Diagnose by criteria. Confirm by laboratory and other investigations. A broad panel of tests provides a more robust basis to identify symptom patterns, abnormalities and orient treatment.

Routine laboratory investigation: □ CBC, □ ESR, □ CA, □ P, □ RBC Mg, □ vitamin D3, □ B12 & folate, □ ferritin, □ zinc, □ FBS, □ PC, □ Hb A1C, □ serum electrolytes, □ TSH, □ protein electrophoresis screen, □ CRP, □ creatinine, □ ECG (U+ T wave notching), □ CPK and liver function, □ rheumatoid factor, □ antinuclear antibodies, □ urinalysis, □ essential fatty acids,
□ CoEnzyme Q10, □ immunoglobulins, □ diurnal cortisol levels, □ TTG, □ serotonin

Additional laboratory investigation: (as indicated by symptoms, history, clinical evaluation, lab findings, risk factors) □ 24 hour urine free cortisol, □ DHEA sulphate, □ ACTH, □ chest x-ray,
□ hormones including free testosterone, □ panoramic x-ray of dental roots, □ amino acid profile,
□ abdominal ultra sound, □ lactose/fructose breath test

Further testing with specificity to ME, if and as indicated. Some tests are in the research stage but can identify abnormalities and focus treatment. Viral tests should be interpreted by a physician experienced in these infections.
Pathogen: □ Enterovirus; Tests: RT-PCR, serology, stomach biopsy
Pathogen: □ mycoplasma; Tests: DNA-PCR, serology
Pathogen: □ EBV, □ CMV, □ HHV-6; Tests: DNA-PCR, serology, antigenemia
Pathogen: □ Borrelia burgdorferi; Tests: DNA-PCR,serology, Western Blot
Pathogen: □ Clamydia pneumonia; Tests: DNA PCR, serology
Pathogen: □ Parvovirus B19; Tests: DNA-PCR,IgG, IgM,

Immune system profiles: □ *↓NK cell function & ↑cytotoxicity; □ B & T-cell function: □ IgG,
□ IgG subclasses 1-4; □ IgA, □ IgM (shift from T1 to T2), □ cytokine/chemokine profile panel (94% accuracy): IL-8, IL-13, MIP-1β, MCP-1, IL4, □ flow cytometry for ↑ lymphocyte activity,
□ ↑37 kDa 2-5A RNase L immunoassay – defect/ratio & bioactivity, □ food sensitivity panel,
□ chemical sensitivities, □ stool for WCB - D-lactic acid bacteria balance, ova & parasites,
□ autoimmune profile, Intestinal dysbiosis: □ IgA & IgM for intestinal aerobic bacteria in serum, □ ↑ leukocyte elastase activity in PBMCs, □ IgG food intolerance test, □ toxoplasmosis

Neurological & static testing: □ *SPECT scan with contrast - ↓ cortical/cerebellar region cerebral blood flow (rCBF) in the frontal, parietal, temporal and occipital & brain stem regions - more brain involvement indicates increased illness severity, □ MRI of brain – (increased T2-weighted images in high white matter tracts & loss of GM volume) & rule out MS, □ MRI of spine (dynamic disc bulges/herniation , stenosis), □ sleep study (↓ stage 4 sleep, sleep pattern & rule out treatable sleep dysfunctions – upper airway resistance syndrome, sleep apnea, etc.)

PENE: In a 2 consecutive day comprehensive 8-12 minute cardiopulmonary exercise stress test (measuring heart, lung, and metabolic function) - only ME patients have significantly worse scores the second day & abnormal recovery from exertion. * Exercise tolerance test with expired gas exchange - (2 consecutive days) – measure cardiovascular, pulmonary & metabolic responses at rest & during exercise: □ peak oxygen consumption VO2 or VO2 at anaerobic threshold (AT) - decline of 8% or greater on test 2 indicates metabolic dysfunction, □ post-exercise blood analysis - increase in sensory, adrenergic and immune genes - increase in metabolite receptors unique to ME

Energy metabolism/ion transport: □ ATP profile – identifies insufficient energy due to cellular respiration dysfunction □ further ATP related parameters, superoxide dismutase and cell-free DNA Respiratory: □ pulmonary function test Cardiovascular: □ Tilt table test to confirm OI (70 -80% tilt, measure HR continuously, BP periodically – 30 min or presyncope); □ Cardiac output decreases - left ventricular dysfunction in the heart; □ 24-Hour Monitor for suspected arrhythmia, NMH/POTS, myocarditis (Note: Repetitively oscillating T-wave inversions &/or T-wave flats, typical of ME, may be subsumed under non-specific T-wave changes.)

And here is the research rationale for the ME-ICC:
Criteria are supported by research

Criterial symptoms are supported by a study of more than 2500 patients that determined which symptoms had the greatest efficacy to identify patients with ME [22]. Investigations into gene expression [23–27] and structure further support the criteria at a molecular level including anomalies of increased oxidative stress [4, 28], altered immune and adrenergic signalling [29, 30] and altered oestrogen receptor expression [31]. In addition, evidence supporting a genetic predisposition to ME points to modifications in serotonin transporter genes [32, 33], the glucocorticoid receptor gene [34], as well as HLA class II involvement [35]. The potential combinatorial effects of these modifications have received limited attention [33, 36]. Some early broad-based studies show a lack of objective findings such as no association with HLA genotype [37]. A study of patients from a twin registry suggested that environmental factors may outweigh any genetic predisposition in broader patient populations [38].

Underlying problems of inconsistent findings in research studies have been identified [39, 40] and include a need for studies to be based on larger sample sizes with a more clearly defined phenotype, in particular one that recognizes the likely existence of significant subgroups within the patient population. In a study of the Reeves empirical criteria [16], Jason et al. [18] reported that 38% of patients diagnosed with major depressive disorder were misclassified as having CFS and only 10% of patients identified as having CFS actually had ME. Accordingly, the primary goal of this consensus report is to establish a more selective set of clinical criteria that would identify patients who have neuroimmune exhaustion with a pathological low threshold of fatigability and symptom flare in response to exertion. This will enable patients to be diagnosed and enrolled in research studies internationally under a case definition that is acceptable to physicians and researchers around the world.

Postexertional neuroimmine exhaustion (PENE pen′-e)

‘Malaise’– a vague feeling of discomfort or fatigue [41] – is an inaccurate and inadequate word for the pathological low-threshold fatigability and postexertional symptom flare. Pain and fatigue are crucial bioalarm signals that instruct patients to modify what they are doing in order to protect the body and prevent further damage. Postexertional neuroimmune exhaustion is part of the body’s global protection response and is associated with dysfunction in the regulatory balance within and between the nervous, immune and endocrine systems, and cellular metabolism and ion transport [42–46]. The normal activity/rest cycle, which involves performing an activity, becoming fatigued and taking a rest whereby energy is restored, becomes dysfunctional.

Numerous papers document abnormal biological responses to exertion, such as loss of the invigorating effects of exercise [20], decreased pain threshold [47–49], decreased cerebral oxygen and blood volume/flow [50–53], decreased maximum heart rate [54], impaired oxygen delivery to muscles [55], elevated levels of nitric oxide metabolites [56] and worsening of other symptoms [57]. Patients reach the anaerobic threshold and maximal exercise at a much lower oxygen consumption level [58]. Reported prolonged effects of exertion include elevated sensory signalling to the brain [59] that is interpreted as pain and fatigue [29], elevated cytokine activity [60], delay in symptom activation [61] and a recovery period of at least 48 h [57]. When an exercise test was given on two consecutive days, some patients experienced up to a 50% drop in their ability to produce energy on the second evaluation [62]. Both submaximal and self-paced physiologically limited exercise resulted in postexertional malaise [48].

Neurological impairments

Some viruses and bacteria can infect immune and neural cells and cause chronic inflammation. Structural and functional pathological abnormalities [3] within the brain and spinal cord suggest dysregulation of the CNS control system and communication network [62], which play crucial roles in cognitive impairment and neurological symptoms [20]. Neuroinflammation of the dorsal root ganglia, gatekeepers of peripheral sensory information travelling to the brain, has been observed in spinal autopsies (Chaudhuri A. Royal Society of Medicine Meeting 2009). Identified cerebrospinal fluid proteomes distinguish patients from healthy controls and post-treatment Lyme disease [63]. Neuroimaging studies report irreversible punctuate lesions [64], an approximate 10% reduction in grey matter volume [65, 66], hypoperfusion [50, 67–71] and brain stem hypometabolism [1]. Elevated levels of lateral ventricular lactate are consistent with decreased cortical blood flow, mitochondrial dysfunction and oxidative stress [72]. Research suggests that dysregulation of the CNS and autonomic nervous system alters the processing of pain and sensory input [29, 47, 73, 74]. Patients’ perception that simple mental tasks require substantial effort is supported by brain scan studies that indicate greater source activity and more regions of the brain are utilized when processing auditory and spatial cognitive information [75–77]. Poor attentional capacity and working memory are prominent disabling symptoms [20, 75, 78].

Immune impairments

Most patients have an acute infectious onset with flu-like and/or respiratory symptoms. A wide range of infectious agents have been reported in the subsets of patients, including xenotropic murine leukaemia virus-related virus (XMRV) [79] and other murine leukaemia virus (MLV)-related viruses [80], enterovirus [81–83], Epstein–Barr virus [84], human herpes virus 6 and 7 [85–87], Chlamydia [88], cytomegalovirus [89], parvovirus B19 [90] and Coxiella burnetti [84]. Chronic enterovirus infection of the stomach and altered levels of D Lactic acid-producing bacteria in the gastrointestinal tract have been investigated [82, 91]. Possibly, the initial infection damages part of the CNS and immune system causing profound deregulation and abnormal responses to infections [4]. Publications describe decreased natural killer cell signalling and function, abnormal growth factor profiles, decreased neutrophil respiratory bursts and Th1, with a shift towards a Th2 profile [4–8, 92, 93]. Chronic immune activation [27], increases in inflammatory cytokines, pro-inflammatory alleles [4–8, 94–96], chemokines and T lymphocytes and dysregulation of the antiviral ribonuclease L (RNase L) pathway [62, 97–100] may play a role in causing flu-like symptoms, which aberrantly flare in response to exertion [5, 92].

Energy production/transport impairments

The consistent clinical picture of profound energy impairment suggests dysregulation of the mitochondria and cellular energy metabolism and ion transport and channelopathy [9–11, 100, 101]. A biochemical positive feedback cycle called the ‘NO/ONOO- cycle’ may play a role in maintaining the chronic nature of ME, the presence of oxidative stress [102–104], inflammatory cytokine elevation [94–96] and mitochondrial dysfunction [105–108] and result in reduced blood flow and vasculopathy [106, 107].

Findings of ‘small heart’ with small left ventricular chamber and poor cardiac performance in patient subsets [109, 110] support previous reports of cardiac and left ventricular dysfunction [13, 111, 112], which predispose to orthostatic intolerance [14, 113]. Low blood pressure and exaggerated diurnal variation may be due to abnormal blood pressure regulation [114]. Altered control and reduced cortisol production during and following exercise may be involved. Orthostatic intolerance is associated with functional impairment and symptom severity [115]. Measurable vascular abnormalities suggest that the brain is not receiving sufficient circulating blood volume in an upright position [12, 113], which is intensified when standing in one place such as a grocery store check-out line. Significant reduction in heart rate variability during sleep is associated with poor sleep quality and suggests a pervasive state of nocturnal sympathetic hypervigilance [116].
 
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adin

The old guy now
Messages
115
Is PR presenting in person, via webcam/video?
We'll be presenting remotely via videoconference. I assume we'll be able to screenshare or will be able to give the committee written notes.
 

Denise

Senior Member
Messages
1,095
We'll be presenting remotely via videoconference. I assume we'll be able to screenshare or will be able to give the committee written notes.
Thanks Adin.
It is nice to know that videoconference is an IOM option.

I assume also that any written material can be provided to the IOM email address mecfs@nas.edu