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Justin's Written Comments for IoM Panel First Meeting

justinreilly

Senior Member
Messages
2,498
Location
NYC (& RI)
Hi everyone,

EDIT: here is my final draft which I have sent in (the attached PDF is also updated to the final draft).

I have drafted some comments that I'm going to submit to the IoM panel before their first meeting. (I am not going to present comments in person).

Like last time, I would appreciate it if you could support my comments, and/or any others you like such as Jeannette Burmeister's (which she has not posted yet) whether or not you send in your own comments. And, considering that we all have such limited health and energy, I would also suggest that instead of writing your own comments, you consider writing in and simply endorsing this and/or anyone else's comments you like.

If you wish, you could use the saved energy in the fight to stop the contract, which fwiw, I think is more important than interacting with IoM. (I am of course not trying to stifle anyone's voice, please write your own comments if you wish, just suggesting an energy-saving measure). Or feel free to use excerpts (no attribution needed).

I have also attached a PDF file of the letter.

I haven't sent these in, so you can make comments if you see any mistakes, etc.

If you don't have time to read the letter here are my points:
  • The Contract Must be Cancelled
However, in the case that the contract proceeds, God forbid:
  • Non-Experts Must Defer Completely to the ME/CFS Experts
  • Adopt the Canadian Consensus Criteria
  • The ME/CFS Definition Must of Course be Entirely True and Accurate
  • Adopt the Term "ME"
  • Neither Employ the Invalid Reeves or “Oxford” Criteria, nor the Term "CFS"
  • Health and Human Services has Set Up this Process to Arrive at an Inaccurate Definition Once Again
  • Please Listen to Representative Experts and Patients like Jeannette Burmeister, not CAA and PANDORA
  • At This First Meeting, Please Publically Disclose all Relevant Information About Yourselves

Justin Reilly, esq.
[redacted]

January 21, 2014

By Email

ME/CFS Definitional Study Panel
Institute of Medicine
500 Fifth St., NW
Washington, DC 20001
mecfsopensession@nas.edu

Re: Chief Considerations in Redefining ME/CFS


Dear Ladies and Gentlemen of the Panel:

I appreciate the opportunity to comment to the Panel.

The Contract Must be Cancelled

Fifty of the world’s top ME/CFS experts have demanded that the present Health and Human Services (hereinafter “HHS”) contract with the Institute of Medicine (“IoM”) to redefine Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (“ME/CFS”) be cancelled.[1] This represents the large majority of experts in the field of ME/CFS. This demand has been expressly endorsed by 197 patient advocates and professionals[2] and over 3,600 patients and allies.[3]

I fully oppose the contract, both on the merits and because the vast majority of experts demand it be cancelled. I am only submitting comments here to attempt to mitigate any damage it might cause. However, in the case that the contract proceeds, please take the following into account:


The ME/CFS Definition Must of Course be Entirely True and Accurate

This heading may seem self-evident and you may entirely agree. Even if that is the case, please bear with me.

The “first-principle” and bedrock of any definition, especially a disease definition, where the health of millions is at stake, is that the definition must be as entirely true and accurate as is humanly possible. This means that truth and accuracy must not be sacrificed to any extent to any other considerations, including process and the influence of others. Thus, if anyone or any institution instructs you to do something that will result in a definition which is untrue or inaccurate to any extent, you absolutely must not do it. This is a solemn moral and scientific obligation you have as someone who will define a disease, especially a disease whose sufferers have been largely abused and neglected by the government, science and medicine.

For example, if you are instructed that you may only consider a certain type of evidence, even if that evidence is distorted and inaccurate and there exists evidence that is more accurate, which you are instructed not to consider, you must, as a moral and scientific principle, ignore that direction and consider the most accurate evidence and not the inaccurate evidence.

The only way to ensure that the definition will be true and accurate is that you only consider true and accurate evidence. The only practicable way that you will be able to narrow your sights to solely true and accurate evidence is to always defer completely to the ME/CFS experts on the panel.

They are the ones who have each spent decades treating and observing patients first hand, reading the literature and weeding out the studies that employ invalid definitions and faulty reasoning. And they are the ones who have done the bona fide science. You simply cannot substitute your judgment for theirs and hope to arrive at an entirely true and accurate definition.


Non-Experts Must Defer Completely to the ME/CFS Experts

Any non-experts on this panel should accord complete deference to the ME/CFS experts. If anything anyone says conflicts with the above principle, please do not give it any credit and instead defer to the experts on the panel.

This is necessary because it will be impossible for a non-expert to adequately comprehend the science of ME/CFS in toto in the short time period required. This is due to the following reasons:

(1) the disease itself is very complex;

(2) the science of the disease has been extremely underfunded;

(3) the science of the disease has been intentionally warped, most significantly by CDC,[4][5] NIH[6] and the “Wessely School”[7][8] of ME/CFS psychiatry

Additionally, you will be fatally hobbled if you rely substantially on the body of “evidence-based medicine” (“EBM”) that will be presented to you, since EBM is particularly ill-suited for evaluation of the evidence base of ME/CFS science.

Moreover, it is contractually mandated that the present panel be “a committee of thought leaders and stakeholders” regarding ME/CFS.[9] The only reasonable reading of this contractual provision is that should any panelist not be an ME/CFS “thought leader or stakeholder” (i.e. not an ME/CFS expert or patient), he or she must, under the contract, defer to those who are.

Finally, in order to define a disease, one must have either first-hand clinical experience with many patients and/or a body of science available, based upon relatively accurate existing definition(s), which science is capable of reliably distinguishing the disease from healthy states and other illness states by means of laboratory (or clinical) signs. Because the only relatively accurate existing definitions are CCC and ICC, you must mainly rely on these definitions. The number of studies using CCC is quite small and there is only one study, to my knowledge using ICC. Therefor, at present, it is not quite possible to formulate a practical clinical definition that relies entirely on signs. Thus, first hand clinical experience is absolutely essential in defining this disease. Non-experts obviously do not have this experience;

In order for you to learn accurate information about ME/CFS, I strongly urge that before you do anything else, you please start today by reading the three indispensible documents on the disease (all three drafted exclusively by the top ME/CFS experts):

(1) the 2003 ME/CFS Canadian Consensus Criteria;[10]
(2) the 2011 ME International Consensus Criteria[11] and
(3) the 2012 IACFSME ME/CFS Physician Primer[12]


Adopt the Canadian Consensus Criteria and the Term "ME";
Neither Employ the Invalid Reeves or “Oxford” Criteria, nor the Term "CFS"


Adopt the ME/CFS Canadian Consensus Criteria (“CCC”). Fifty experts have demanded that HHS adopt the CCC as the sole ME/CFS definition.[13] 197 patient advocates and professionals[14] and over 3,600 patients and allies[15] have expressly endorsed this demand of the experts.

The one improvement I ask you make to the CCC is to change the name from “ME/CFS” to “ME.” Please retire the misleading term "CFS.” Switch to what has always been the official name of this disease according to the World Health Organization’s International Classification of Diseases (“ICD”): Myalgic Encephalomyelitis (“ME”). Fatigue of unknown cause will be labeled, as always, Idiopathic Chronic Fatigue.

You must not consider any studies, or review papers that incorporate studies, that use the Reeves Criteria and 1991 Sharpe (aka ”Oxford”) Criteria, both of which are patently invalid. The Reeves Criteria invalidly defines ME/CFS as simply being people with very low function. The “Oxford” Criteria defines ME/CFS as simply six months of Idiopathic Chronic Fatigue.


Health and Human Services has Set Up this Process to Arrive at an Inaccurate Definition Once Again

Please realize that HHS has continually, over the last thirty years, attempted to warp and retard the science of ME. The only reasonable conclusion, given the facts, is that this contract is another such attempt. The ME expert physician and research community has demanded that HHS not contract with IoM and instead immediately adopt the accurate Canadian Consensus Criteria. HHS wants another inaccurate definition to replace its inaccurate Fukuda and fraudulent Reeves Criteria, and this is the reason this panel exists.

HHS has set up the contract with IoM to arrive at an inaccurate definition. This is being accomplished by several means, not all of which are probably known to anyone except HHS and IoM, since HHS and IoM refuse to release the contract and related documents. This is despite several FOIA requests, the first of which was received by HHS in late September (they have well exceeded the 20 day response period required by law), a lawsuit in Federal District Court to compel HHS to comply with the FOIA request and several informal requests to both organizations prior to the FOIA requests. This begs the question: what are they hiding?

Though we don't have the contract, there are several known means HHS has employed to attempt to ensure that the IoM redefinition is an invalid one.

(1) HHS has contracted with IoM, which has no experience in drafting diagnostic criteria, except with Gulf War Illness/Chronic Multi-Symptom Illness. That redefinition and renaming has so far been horrible. Chronic Multi-Symptom Illness (“CMI”) is an inappropriate name. And the preliminary redefinition of Gulf War Illness (“GWI”) in the January 2013 IoM report was extremely inaccurate. The current IoM panel to redefine GWI has virtually no experience with the syndrome and is rife with disclosed and undisclosed conflicts of interest and biases.

(2) At least five of the nine volumes of the IoM report “Gulf War and Health” have included sections on ME/CFS that have been egregiously inaccurate, totally ignoring the mountains of proof that ME/CFS is an organic disease. Thus HHS picked IoM, since IoM has shown time and again that it will only describe ME/CFS in extremely inaccurate terms.

(3) HHS has mentioned in the Statement of Work (“SoW”)[16] to this contract that the redefinition should be "evidence-based." Evidence-based Medicine is particularly unsuited for redefining ME/CFS and will result in a skewed definition.

(4) IoM requires that its panels include substantial numbers of non-experts. That is the case here. There are 7 experts and one scientist, Ronald Davis, PhD., who are appropriate for this panel. There are 7 non-experts. This is a disease that especially requires an all-expert panel, such as those that came together for the CCC and ME International Consensus Criteria, for any definition.


Please Listen to Representative Experts and Patients such as Jeannette Burmeister, not CAA and PANDORA

I endorse all oral and any written comments of Jeannette Burmeister, who will be speaking at the meeting, as she accurately represents the views of the vast majority of patients and experts.

The CFIDS Association of America (“CAA”) is not representative of patients.

While PANDORA is a more legitimate organization, its position on the IoM is much less oppositional than that held by the vast majority of the ME community.

These two organization are virtually the only entities in the entire ME community who have stated that they are not actively trying to get the contract cancelled. I am aware of no other organizations and only five people who have expressed a viewpoint this unaggressive to the contract.

Compare this to the over 190 patient advocates and professionals and over 3,500 patients and others who have expressly supported the letter of the 50 experts to cancel the contract and immediately adopt CCC. This in addition to the many patients and advocates who have expressed strong opposition to the contract on internet forums, and in letters, tweets and emails to Congress, the President, HHS, and IoM.

Please also keep in mind that many patients as well as four respected ME/CFS organizations, the National CFIDS Foundation, the M.E. Society of America, the National Association for M.E. and Invest in M.E. have stated they refuse to engage at all with IoM, because they feel that this is a thoroughly illegitimate process that should not be acknowledged. These patients and organizations agree, in my estimation, with the points I have made and certainly with the points of Ms. Burmeister. Thus, I ask you to accord special weight to Ms. Burmeister's comments, since she speaks for many who have not given their input.


At This First Meeting, Please Publically Disclose all Relevant Information About Yourselves

Please disclose all relevant information about yourselves, such as any work you have done on ME/CFS and related topics, and any biases or conflicts of interest.

In conclusion, I strenuously urge you to follow the two main points of this letter:

(1) Always defer completely to the ME/CFS experts on the panel; and

(2) Adopt the Canadian Consensus Criteria (on the merits, and more importantly, because the ME/CFS experts overwhelmingly demand it).

If you wish to speak to me, please feel more than free to contact me at [redacted]. I realize the whole topic of ME/CFS is very confusing, so I am at your service. Thank you for your consideration.


Sincerely,

/s/

Justin Reilly, esq.


[1] Ablashi, Dharam, et al., An Open Letter to the Honorable Kathleen Sebelius, U.S. Secretary of Health and Human Services; Original Letter – September 23, 2013 Update with additional signatures – October 25, 2013; https://dl.dropboxusercontent.com/u/89158245/Case Definition Letter Sept 23 2013.pdf

[2] Allen, Michael, et al., An Open Letter to the Honorable Kathleen Sebelius, U.S. Secretary of Health and Human Services, December 26, 2013; https://www.dropbox.com/s/go3o37oonf0kory/New Letter Signatures.pdf

[3] online petition: “Stop the HHS-IOM contract and accept the CCC definition of M.E.”;
https://secure.avaaz.org/en/petition/Stop_the_HHSIOM_contract_and_accept_the_CCC_definition_of_ME/

[4] Tuller, David, Chronic Fatigue Syndrome and the CDC: a Long Tangled Tale, Virology Blog, November 23, 2011; http://www.virology.ws/2011/11/23/chronic-fatigue-syndrome-and-the-cdc-a-long-tangled-tale/

[5] Johnson, Hillary, Osler’s Web: Inside the Labyrinth of the Chronic Fatigue Syndrome Epidemic (1997), Penguin, ISBN: 978-0140263473

[6] Id.

[7] See the website of Prof. Em. Malcolm Hooper, PhD., http://www.meactionuk.org.uk ; including Hooper, Malcolm, Magical Medicine, http://www.meactionuk.org.uk/magical-medicine.htm

[8] Kennedy, Angela, Authors of Our Own Misfortune?: The Problems with Psychogenic Explanations for Physical Illness, CreateSpace Publishing, 2012, ISBN-13: 978-1479253951

[9] HHS, National Academies Umbrella Contract, Statement of Work/Request for Proposal, Project Title: Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome at p.2, ¶1;

https://dl.dropboxusercontent.com/u/57025850/MECFS IOM SOW.pdf

[10] Carruthers, Bruce et al., Myalgic Encephalomyelitis, Chronic Fatigue Syndrome Clinical Working Case Definition, Diagnostic and Treatment Protocols, Journal of Chronic Fatigue Syndrome (2003), vol. 11(1), p.8;

http://www.cfids-cab.org/MESA/ccpccd.pdf

[11] http://onlinelibrary.wiley.com/stor...nl&s=a9e133d5050b110d1e9f48601854df16e4a9a4b9

[12] http://www.iacfsme.org/portals/0/pdf/primerfinal3.pdf

[13] Ablashi, supra, fn1, id.

[14] Allen, supra, fn2, id.

[15] online petition, supra, fn3, id.

[16] HHS, fn 6, supra, id, p.2, ¶2, no. 2
 

Attachments

  • ME- Letter to IoM Panel re- Chief Considerations- redacted.pdf
    138.5 KB · Views: 4
Last edited:

jspotila

Senior Member
Messages
1,099
Justin, I can't speak for any of the other invited panelists, but I am commenting for the same reason you are: to mitigate the damage that this IOM study may cause. It's unfortunate that you don't think I'm worth listening to.
 

Denise

Senior Member
Messages
1,095
If you want to submit written public comment for the open session of January 27th, 2014 IOM meeting on Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome


IOM has said: “It would be most useful if comments are focused on the following question: “What is the most important aspect or information that this committee should consider throughout the course of the study?”

Anyone can submit written comment to the meeting. (No limit on length.) What are you going to tell them?

If you submit by Jan 22nd the committee will get a copy of them before the meeting on Jan 27. Use this email address – mecfsopensession@nas.edu. Comments submitted after Jan 22 will still go to the committee, but possibly not until after the meeting.

All comments go into the public access file.

Additional info: http://iom.edu/Activities/Disease/D...elitisChronicFatigueSyndrome/2014-JAN-27.aspx

After January 27, send written comments to the project email address (mecfs@nas.edu).

Reminder -the Statement of Work for this project – obtained by Ms Spotila – can be seen here: https://dl.dropboxusercontent.com/u/57025850/MECFS IOM SOW.pdf .

The tentative agenda for the January 27th, 2014 open session of the meeting on Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.
 

golden

Senior Member
Messages
1,831
Justin

Thankyou for starting the thread and sharing your letter.

I am not yet up to speed on all the politics. It is looking fairly accurate to me.

I am not feeling very well so i appreciate some of your comments which brought me additional clarity. I have a framework now to do a bit more research.

i don't yet understand all of it. i hope to before the deadline.

i hope this thread can bring further insights...

Golden

Hopefully
 

golden

Senior Member
Messages
1,831
Can i just ask a silly question. i cant find the answer.

The Hummingbird Foundation for M.E. with Dr.Hyde -

Is their view that the CCC and ICC are incorrect?

This, in their view, would be because M.E. is a testable illness with a specific defined pattern with incubation of x - amount of days etc.

And so M.E. is defined and testable and visible with a SPECT scan.

If its not visible then clinical efforts should be in finding the physical cause eg. vitamin D deficiency and all the other listed physical tests available
 

golden

Senior Member
Messages
1,831
Justin, I can't speak for any of the other invited panelists, but I am commenting for the same reason you are: to mitigate the damage that this IOM study may cause. It's unfortunate that you don't think I'm worth listening to.

jspotila

may i ask are you on this panel?

thanks.
 

justinreilly

Senior Member
Messages
2,498
Location
NYC (& RI)
Justin, I can't speak for any of the other invited panelists, but I am commenting for the same reason you are: to mitigate the damage that this IOM study may cause. It's unfortunate that you don't think I'm worth listening to.

Jennie, I am sorry if I offended you. I probably wouldn't be happy if you said the same of me.

I do think you are very worth listening to.

I made a mistake, Robert Miller is not speaking, so I am going to modify what I wrote to focus on CAA and PANDORA.

Why I wrote this may seem like splitting hairs, but I don't think it is. I was thinking about the overall composition of the invited speakers. Even without Bob, it is skewed to one view and that's what I said. I said don't listen to CAA and PANDORA, they don't represent the vast majority of patient views on this one. I didn't say don't listen to you.

But I asked that views like Jeannette's, who was not invited to speak, be given greater weight than her small proportion of the public speaking time would normally indicate. She is currently the most active patient advocate and a lot of people are behind her and agree with her. The proportion of patients that agree with PANDORA and CAA is tiny.
 

beaker

ME/cfs 1986
Messages
773
Location
USA
I have edited that section above. I may or may not change it further.
Good move Justin.
She's been working very hard getting contract information and background checks on panel members and writing her blog to share in what seems, at least to me, to be a very transparent effort to support the patients -- including herself in a positive way. Thanks J.S. from one too sick to do that work.
 

justinreilly

Senior Member
Messages
2,498
Location
NYC (& RI)
Thank you Justin, Jennie, Jeannette - our Gentleman and Ladies Justice. :)

(And @justinreilly, I'd like to buy an "n" for "Jean(n)ette" in bold above, please. :D)

Done, thanks for the catch.

I have changed my summary to:

"In conclusion, I strenuously urge you to follow the two main points of this letter:

"(1) Always defer completely to the ME/CFS experts on the panel; and

"(2) Adopt the Canadian Consensus Criteria (on the merits, and more importantly, because the ME/CFS experts overwhelmingly demand it)."

I think we should all hammer home these two main points, especially adopting CCC because the experts demand it.
 
Last edited:

justinreilly

Senior Member
Messages
2,498
Location
NYC (& RI)
It worries me that you don't know about Dr.Hydes position .

I am after an accurate overview and summary of each group without personal bias.

Golden

I have Dr. Hyde's book and have read it twice. I think he's great. He has a different view of ME from the general consensus among the experts of what ME is. I am not expert enough to say who is right.

He didn't sign the 50 expert letter.

Regardless of his viewpoint, out of political necessity, I think we really need to support the 50 expert letter which demands CCC. Sticking together as a united front as much as possible is essential for us to win this battle and this war.