Article: NIH Steering Committee Wants Your Input!

Article: NIH Steering Committee Member Mary Schweitzer Asks for Community Input

You can view the page at http://forums.aboutmecfs.org/content.php?317-NIH-Steering-Committee-Member-Mary-Schweitzer-Asks-for-Community-Input

 

1. A hard look needs to be taken at all infectious pathogens....enteroviruses (Dr. Chia's work), Herpes viruses (Dr. Montoya's work), XMRV, borna viruses and others.

2. For experts I would recommend Dr. Montoya and Dr. Ian Lipkin...they are currently doing research in this area.

3. Infectious pathogens are likely the cause of a subset of patients with CFS. These pathogens need to be identified, testing standardized, and treatment initiated.

 

I agree - I think there should be a focus on identifying the infectious subset - that 30% Dr. Peterson talks about; that will help them and the 70% of the other patients since by separating them you'll get better study results.

 

Besides the viral angle, i would like to see studies on our unusual problem with quality of sleep.
Most of us that had sleep studies done show that we don't reach the slow wave deep sleep stage of sleep.
I think that this is a major contributor to our cognitive problems.
I also think that it might be the major contributor to our overwhelming fatigue.

 

I agree that the quality of sleep is an issue. However, the disease is what causes the symptoms. I think focus on the Post-exertional process is an essential factor. It just seems that the lack of oxygen production, slowly takes us apart one major organ at a time. We need a direct diagnosed and treatment that will stop the process in less than 20 years. What most people with ME/cfs are doing is to demean themselves with terms as "brain fog" when they should really be saying I am so exhausted, I need to rest to be able to think clearer. No Sleep, No Oxygen, No Chance!

The infectious pathogens definately need to be understood because the one thing I am seeing from a huge number of people is that they became ill following "'mandatory" vaccination of one kind or another. That seems to be the health care focus now. There are 2 main groups of people who are dealing with ME: Professionals from within various tiers of the health care services and children.... all "required to be vaccinated". Who is making these vaccinations and are they safe.

I don't know about selecting the right experts just yet, but I am very impressed with the Candidate list I saw posted for Patient Reps. I believe inviting us to the table is very strong statement. This is a tough calling to represent this patient population, and I reflect on the comments made by Dr. Jason at the close of October's CFSAC Hearings. This will help us have more input, and hopefully improve the progress. If only one thing came out of the conference I think it needs to be Cognitive Behavioral Diversity Training for the entire Science, Medical Schools and Praciticing Physicians who have been turning their backs to the devistation this disease has on innocent people. They could all uses some fast-tracking on their functional practice knowledge of how neglect causes more harm than they want to acknowledge.

 

1 Low blood volume/cardiac output in ME/CFS. http://www.ncbi.nlm.nih.gov/pubmed/19469714

2 Peter Rowe, Marvin S. Medow, Stewart JM, Hurwitz BE, Peckerman A, David S. Bell.

3 New low blood volume/cardiac output research including measurements of atrial natriuretic peptide, vasopressin, renin, angiotensin, aldosterone, norepinephrine and epinephrine.

 

An analysis of currently testable parameters of M.E./Fibro symptoms. So if there are symptoms which occur in x% of M.E. patients, isolating their legitimacy, through testing.

A lot of M.E. people seem to indicate that their symptoms go un-helped because they do not have adequate and appropriate testing (seems to happen a lot in the UK). Consequently no subsequent treatment for individual symptoms can be instituted. It seems to me there may be a number of M.E. people who cannot get out of their beds because some important diagnostics have not been investigated sufficiently for distressing individual symptoms for which there may be some available treatment. This is not to say that this is everyone who is bedbound with M.E. but possibly some.

A couple of Examples (and there are many more) are:
1). Orthostatic intolerance or postural hypotension
Cause: Hypovolaemia; Anaemia etc.
Testing = Frequent blood pressure readings, tilt table testing etc. etc.
Treatment = Florinef; Mestinon: adequate salt in diet; anaemia correction etc.

2). Delayed Oesophageal/Gastric Motility or Emptying
Cause: Post viral; Vagus nerve damage; Autonomic neuropathy etc.
Testing = Oesophageal Manometry; GES-Gastric Emptying Study; EGG-Electrogastrogram etc. Treatment = Dietary modifications (extensive - Dietitian); Prokinetics; Gastric pacemaker (if severe) etc

So these are not necessarily looking at a cure for M.E. per se (for the purposes of this exercise) but looking at individual symptoms which can firstly be correctly diagnosed and then helped through existing treatment protocols.

 

Dysautonomia and ambulatory hypoxia!

 

An ME/CFS "Treatment Protocol" that addresses ALL of the following:

1. Infections--retroviral, viral, bacterial, fungal, parasitic both primary and opportunistic
2. Immune system abnormalities--NK cell, T-cell, B-cell, cytokine plus testing for and treatment of underlying primary immune deficiencies of genetic origin
3. Blood volume loss-- Daxor BVA-100 testing
4. Multiple chemical/medication sensitivities--P450 enzyme testing
5. Exertional relapse--Light's testing
6. Cognitive functioning

 

Biomarkers, biomarkers, biomarkers!

Without an objective, measurable way to define *who* has the disease research will continue to be confounded by cohort heterogeneity. I would argue, therefore, that a vital first step is to collate the work of Drs Klimas and Kerr, Staci Stevens and others to determine a set of screening tests that can reliably discriminate between a person with ME/CFS and someone with idiopathic chronic fatigue.

Is ME/CFS, as currently diagnosed, one disease with one cause, or is it one disease with many causes (eg. a final common pathway for occult infection with different pathogens) or a number of different diseases with a similar symptomatic presentation? I would guess the latter but biomarkers would allow for a clinically meaningful aggregation / disaggregation of patients and clear the way for research into the cause(s).

Finally, biomarkers would free us from the shrinks and legitimise the disease - no longer could your GP / PCP shrug his/her shoulders and (privately) label you neurotic; insurance companies would have to pay out; and, perhaps of equal importance, family and friends will understand that *you really are ill*.

 

We need access to viral chips to have any idea of where to begin in treating viruses. Individual tests are missing so much.

 

A comprehensive and unabiguous description of the immune dysfunction in ME/CFS.

Establishing once and for all that it is a neuro-immune disease and should be treated accordingly and freeing us from being held hostage to contradictory findings, blocks on publication, media reporting bias, contamination theories etc.

Upstream and downstream investigations can follow.

 

Question #1:
i'm going to cheat and pick two areas to cover:

(a) Fundamentals- this can be done by running through the ME/CFS Canadian Consensus Definition document.

(b) A primer on why there is so much confusion and doubt about ME & basic pitfalls to avoid when conducting research or communicating on ME.

I would include in this a short mention that CDC, NIH and the small cadre of british psychiatrists and the UK govt have purposefully caused all this confusion and they are not sources to rely upon for accurate ME info. Also that the best definition of ME is the Canadian CC, CDC Fukuda is ok and CDC Reeves and 1991 Sharpe/Oxford are totally invalid. Tell them to always look at the definition that was used to produce the data and that the studies that say its psychogenic rather than somatogenic are always purposefully using the invalid definitions. Use "ME" to refer to the disease in papers and elsewhere (never "CFS").

no response for question 2

Question #3:
A commitment by NIH to request adequate funding from congress, say $1 Billion per year for ME research (and obviously have it spent on legitimate studies)!

Thanks Mary! I'm so glad you are on this committee. All of this is a great sign that NIH is now taking this seriously.

 

Biomarkers, biomarkers, biomarkers!

Without an objective, measurable way to define *who* has the disease research will continue to be confounded by cohort heterogeneity. I would argue, therefore, that a vital first step is to collate the work of Drs Klimas and Kerr, Staci Stevens and others to determine a set of screening tests that can reliably discriminate between a person with ME/CFS and someone with idiopathic chronic fatigue.

Is ME/CFS, as currently diagnosed, one disease with one cause, or is it one disease with many causes (eg. a final common pathway for occult infection with different pathogens) or a number of different diseases with a similar symptomatic presentation? I would guess the latter but biomarkers would allow for a clinically meaningful aggregation / disaggregation of patients and clear the way for research into the cause(s).

Finally, biomarkers would free us from the shrinks and legitimise the disease - no longer could your GP / PCP shrug his/her shoulders and (privately) label you neurotic; insurance companies would have to pay out; and, perhaps of equal importance, family and friends will understand that *you really are ill*.

Well, there are plenty of biomarkers as far as I am concerned, but if you go by the official information, it claims there are no biomarkers.

I have enough biomarkers and very specialized testing that can make the most skeptical of the skeptics believe that I am physically and neurologically ill.

That's if they don't judge me first by looking at me, and claim the results must be falsified since I don't look like I am dying or even have a flu. I am even good at acting symptom free (most days) when in reality symptoms are present at all times and I feel like hell inside.

Biomarkers exist. We just need someone like Cheney and friends to inform our wonderful government on what these biomarkers are.

And of course, we can always look for more. That would never hurt.

1. If there was only one topic covered, what would you want it to be (besides XMRV)?

I agree that biomarkers should be at the top of the list for discussion. This could be sorted out relatively quickly in my opinion if certain individuals get their head out of the sand.

If this is not the topic of discussion, I think they should talk about various bacterial and viral infections involved in this disease, opportunistic pathogens, and more importantly, our state of immunodeficiency.

I went from bed bound to functional with the help of long-term antibiotics. If I go off, I get worse (to the point of psychotic like episodes) in the matter of weeks.

 

Co-Infections, Co-Infections, Co-Infections.......there is a reason why so many of us are having recurring, or chronic, whatever you want to call it, EBV, HHV-6a, CMV, Etc., (and not only the herpes viruses-there's so many more) We need serious research as to who is going to benefit from treating these infections, and moreso-what defect or dysfunction in the IMMUNE system is allowing these infections to continue? And I believe many people will need more than just antivirals-something also targeted at the Immune system at large. Why do some people improve on Antivirals, and others do not, when they could have such similar disease onsets and the same viruses at similar levels? What else is happening?

SLEEP DYSFUNCTION. Why are some people with ME/CFS Hypersomniacs (I'm meaning, sleeping excessive periods of time without medication) while others have extreme Insomnia, or total dysruption of their sleep cycle? And why, no matter what, are we all waking up feeling worse than when we went to sleep, "poisoned", achey, exhausted? Why can't we reach stage 4 sleep anymore? And what medications can be studied to perhaps help this area? I don't know any ME/CFS patient who can't say that even ONE poor nights (or days) sleep will leave them feeling totally debilitated, ill, and often in pain.

What differences are there in the Immune System, Endocrine system, etc. of Hypersomniacs vs. Insomniacs in ME/CFS patients?

A NEW NAME CHANGE IS A MUST I don't feel we will ever get legitimacy until CFS is abandoned- there is simply too much stigma attached to it.

 

Mary, thank you very much for working on the Committee.

Question 1...one topic besides XMRV: "treatment." Existing treatments plus those in the pipeline for infections, immune abnormalities, blood volume loss, PEM, chemical/medication sensitivities, and cognitive functioning. Getting patients treated now based on existing scientific knowledge.

Question 2...experts who can design and implement large clinical "treatment" trials and set up and run clinics for infectious neuro-immune diseases. Dennis Mangan started this at the last CFSAC.

Question 3...desired meeting outcome: a plan to get clinics like Standford and WPI up and running in 2011 and expanded in 2012 and beyond.

 

1. I think this disease has to be defined and biomarkers agreed upon - preferably as a neuro-immune one. It should be simpler than CCC and not be defined by vague symptoms like fatigue, malaise, etc.

2. Somebody with broad understanding of ME/CFS and has been around the block. No fence sitters. Somebody who can stick their neck out when necessary.

3. Commitment to funding real research, not calling up random people in rural Georgia and Wichita. No mind-body BS.

 

DNA microarrays - and More Precise Data

We need access to viral chips to have any idea of where to begin in treating viruses. Individual tests are missing so much.

I second that point, but not just from the perspective of treatment: also for the advancement of scientific understanding of chronic fatigue syndrome.

I know that ViroChips (more generally called DNA microarrays, DNA arrays or biochips) are an emerging technology (they have been around for 10 years or so), but since they identify all pathogens by their genetic makeup, this presumably will allow more precise and rapid identification of viral/bacterial subtypes (eg, distinguish HHV-6A from HHV-6B); the difference from one subtype to the next can make a lot of difference to whether a microbe is benign or pathogenic. We need this very precise testing; we need this exact data.

I believe DNA microarrays should also more easily pick up intracellular viruses in CFS such as enteroviruses, which Dr John Chia, and Dr Nora Chapman et al, say live within cells as RNA strands (with the RNA strand genes likely to be actively transcribing themselves in the cell). But don't quote me on that, as I am not familiar with the exact capabilities of these DNA microarrays devices.

Plus DNA microarrays should be more easily able to pick up and identify all bacterial, fungal and protozoa in the gut, to species/subspecies level.

At least this is my understanding of the power and potential of DNA microarrays. In general, whether it is DNA microarrays or some other system, we need significantly more accurate testing for CFS pathogens.

In summary: the hypothesis that CFS is a condition whose fundamental or main cause is a chronic infection with one or more pathogens needs to be taken very seriously: this means that precise data needs to be gathered on the nature of the pathogens (down to subtype/genetic level) found in CFS patients. Without this data, you cannot properly develop cause-and-effect theories for these CFS pathogens.

The NIH are currently engaged in the Human Microbiome Project, which "aims to characterize the microbial communities found at several different sites on the human body, including nasal passages, oral cavities, skin, gastrointestinal tract, and urogenital tract, and to analyze the role of these microbes in human health and disease".

Thus the NIH should appreciate more than most the need to precisely characterize the pathogens linked with CFS.

 

From Hanna Kristi

1. Please please please change the name to myalgic encephalomyelitis.

2. Please get knowledge out to other physicians. I have a whole constellation of problems due to this disease and they all think I’m “fine” because they don’t recognize the disease, much less have heard of it. This is going on 17 years now.

3. It’s almost funny that they take CFS/ME serious enough to have us not donate blood but after that it’s “CFS what?”

 

Cort, do you know when the "gathering suggestions" will stop?

Because if it hasn't stopped yet, I have another wish list item besides biomarkers biomarkers biomarkers - which remains a #1 priority in my mind - how about some decent mortality statistics applied to the long-term ill?

I mean, bless Dr. Jason for trying, but pulling some names off an Internet memorial list doesn't make for very robust science. If we had solid information on what our mortality stats really are - how much earlier are we dying than the average person, and what are we dying of? - it could lead to better long-term care (i.e., what to watch out for - perhaps we should be aggressively screened for the cancers we tend to get) and also go further toward 'validating' the disease and lending a sense of urgency to all ongoing research, if the early-death stats are dramatic - which I'm guessing they would be. But it has to be from good studies using good disease criteria.