List of nominees to the IOM panel by patient groups and advocates

[Nielk]

PANDORA’s list of nominees:


Pathophysiology

Kenneth Friedman, PhD

Gordon Broderick, PhD

Andreas Kogelnik, MD, PhD

Prof. Kenny de Meirleir, MD, PhD



Spectrum of Disease

Leonard Jason, PhD

Dan Peterson, MD

Lucinda Bateman, MD



Clinical Expertise / Primary Care

Lucinda Bateman, MD

Susan Levine, MD

Dan Peterson, MD

Charles Lapp, MD

Alan Pocinki, MD

Nancy Klimas, MD

David Bell, MD

Derek Enlander, MD



Clinical Expertise / Primary Care (cont.)

Andreas Kogelnik, MD, PhD

Peter Rowe, MD



Neurology

Gudrun Lange, PhD

Roy Freeman, MD

James Baraniuk, MD

Italo Biaggioni, MD

Peter Rowe, MD

Ben Natelson, MD



Immunology

Nancy Klimas, MD

Keith Kelly, PhD

Theoharis Theoharides, MS, PhD, FAAAI, MD

James Oleski, MPH, MD

Mary Ann Fletcher, PhD

James Baraniuk, MD



Pain

Kathleen Light, PhD

Richard Podell, MD

Irwin John Russell, MD, PhD



Infectious Disease

Ian Lipkin, PhD

Ronald Glaser, PhD

John Chia, MD

Jose Montoya, MD

Mady Hornig, MD, MA

Dharam Ablashi, PhD

Nancy Klimas, MD





Cardiology

Julian Stewart, MD, PhD

Martin Pall, PhD

David Bell, MD



Endocrinology

Keith Kelly, PhD

Nancy Klimas, MD

Malcolm Schwartz, D.O.



Rheumatology

Don Goldenberg, MD

James Baranuik, MD



Nursing

Loraine Steefel, DNP, RN, CTN

Laurie DeDecker, RN



Developing Definitions

Leonard Jason, PhD

Bruce Curruthers, MD

Dr. Byron Hyde, MD



Health Care Education

Kenneth Friedman, PhD

Gailen Marshall, MD



Behavioral

Gordon Broderick, PhD

Leonard Jason, PhD

Mady Hornig, MD

Alan Gurwitt, MD

Wilfred van Gorp, PhD

Gudran Lange, PhD



Epidemiology

Leonard Jason, PhD

Kenneth Friedman, PhD



Exercise Physiology and Energy Metabolism

Jane Kent-Braun, PhD

Christopher Snell, PhD

Staci Stevens, MS

Betsy Keller, PhD


Jennie Spotila of occupy CFS list of nominees:


For the record, I nominated Dr. Leonard Jason, Dr. Lucinda Bateman, Dr. Peter Rowe, Dr. Chris Snell, and Dr. Lily Chu.


RMCFA list of nominees:


Expert Clinical Expertise / Primary Care
Andreas Kogelnik, MD, PhD
David Bell, MD
Derek Enlander, MD
Dan Peterson, MD
Lucinda Bateman, MD
Prof. Kenny de Meirleir, MD, PhD

Neurology
Gudrun Lange, PhD
Peter Rowe, MD
Ben Natelson, MD

Immunology
Nancy Klimas, MD

Pain
Kathleen Light, PhD

Infectious Disease
Ian Lipkin, PhD
John Chia, MD
Jose Montoya, MD

Cardiology
Paul R. Cheney M.D., Ph.D.

Developing Definitions
Leonard Jason, PhD
Bruce Curruthers, MD

Behavioral
Gordon Broderick, PhD

Exercise Physiology and Energy Metabolism
Christopher Snell, PhD
Staci Stevens, MS

 

[justinreilly]

CFIDS Association of America has said they will not reveal who they nominated. Wonder what they're hiding.

 

[Nielk]

CFIDS Association of America has said they will not reveal who they nominated. Wonder what they're hiding.

I have asked them for the sake of transparency, to publicly release their list.

 

[Nielk]

I have to question the method of the Institute of Medicine in seeking nominations to the panel. Instead of making a public statement on their website or listserv, they privately contacted some patient groups. How democratic is that? It is only by word of mouth that we have found out about it.

In addition, they gave three day window to come up with a list? Why?

It seems to me that they are trying to slide under the radar with this and just give the minimum needed to make it seem as if they are being fair and as if we really have an input as to this process.

 

[Firestormm]

I have to question the method of the Institute of Medicine in seeking nominations to the panel. Instead of making a public statement on their website or listserv, they privately contacted some patient groups. How democratic is that? It is only by word of mouth that we have found out about it.

In addition, they gave three day window to come up with a list? Why?

It seems to me that they are trying to slide under the radar with this and just give the minimum needed to make it seem as if they are being fair and as if we really have an input as to this process.

Wasn't the 3 days given to PANDORA because they happened (or their president happened) to be attended some event? I forget the details, but I thought people were making nominations wholeheartedly via some email address or other.

Was there then a general deadline?

 

[jspotila]

Wasn't the 3 days given to PANDORA because they happened (or their president happened) to be attended some event? I forget the details, but I thought people were making nominations wholeheartedly via some email address or other.

Was there then a general deadline?

The original deadline was October 11, which was only a few days after groups were contacted. The deadline was extended (although I don't know how formally) to October 18th. From my general reading about the IOM process, they do not usually make a public request for nominations on their website or other venues. They are not required to do so.

 

[justinreilly]

I have asked them for the sake of transparency, to publicly release their list.

So have I, about a week ago and I have not heard back. CAA has told Jennie, as you know, that they won't release; I think that's our answer.

 

[justinreilly]

The original deadline was October 11, which was only a few days after groups were contacted. The deadline was extended (although I don't know how formally) to October 18th. From my general reading about the IOM process, they do not usually make a public request for nominations on their website or other venues. They are not required to do so.

For IoMs first deadline, neither they nor the orgs they contacted made the process or deadline known to patients. For the extended deadline they either didn't tell any patients, or only told very very few, as far as I can tell since the only thing I ever heard about it being extended to the 18th was a single post within a thread by a patient on the 16th. It would seem only a small number of patients found out about the extension and only then late into the extension.

 

[jspotila]

For IoMs first deadline, neither they nor the orgs they contacted made the process or deadline known to patients. For the extended deadline they either didn't tell any patients, or only told very very few, as far as I can tell since the only thing I ever heard about it being extended to the 18th was a single post within a thread by a patient on the 16th. It would seem only a small number of patients found out about the extension and only then late into the extension.

I understand why this is pissing people off. But it is also true that IOM has no obligation to make a public open call for nominations. They do not operate under the same restrictions as CFSAC.

 

[Nielk]

I understand why this is pissing people off. But it is also true that IOM has no obligation to make a public open call for nominations. They do not operate under the same restrictions as CFSAC.

I can see how this will be the ongoing theme for this process. 'They have no obligation to....select from the nominations from patient'. 'They have no obligation to ......include experts with actual experience with patients'.

How could they have any obligations to do so when never before were they charged to redefine a disease? They should have 'special' rules for panel selection when defining a disease. It is very different from all the other studies that they are paid to do.

This is what Byron Hyde had to say about disease definitions:

"Definitions are not diseases, they are often simply the best descriptions that physicians and researchers can offer, with their always imperfect knowledge, to describe a disease. Good definitions are good because they correspond closely to the disease state being described. It is thus important that those that attempt to define any disease or illness to have long term clinical experience with patients with this illness. **There is simply no place for the bureaucrat in defining illness.** All definition of epidemic or infectious illness must be based upon persistent clinical examination of the afflicted patient, an understanding and exploration of the environmental factors producing that illness, and pathophysiological examination of tissue from those patients. For similar reasons, I believe that the inclusion of psychiatrists in the defining of an epidemic and obviously disease of infectious origin, simply muddies the water for any serious understanding of that disease."

 

[jspotila]

I just posted an explanation of the IOM's conflict of interest policy on my blog. The discussion includes some of the other aspects of selecting IOM panels, including the requirement that the panel be highly competent in the issues, and fairly balanced in membership points of view. If no one on the panel has actual experience with ME/CFS patients, it fails to meet IOM's self-established standards. Personally, I think there's a huge distinction between there being no obligation for a public call for nominations, and the prediction that there is no obligation for experts to have actual experience with patients.

The explanations of what IOM's actual policy says about conflict of interest and bias may be of interest:

http://www.occupycfs.com/2013/11/06/iom-conflict-of-interest-policies/

 

[Nielk]

I just posted an explanation of the IOM's conflict of interest policy on my blog. The discussion includes some of the other aspects of selecting IOM panels, including the requirement that the panel be highly competent in the issues, and fairly balanced in membership points of view. If no one on the panel has actual experience with ME/CFS patients, it fails to meet IOM's self-established standards. Personally, I think there's a huge distinction between there being no obligation for a public call for nominations, and the prediction that there is no obligation for experts to have actual experience with patients.

The explanations of what IOM's actual policy says about conflict of interest and bias may be of interest:

http://www.occupycfs.com/2013/11/06/iom-conflict-of-interest-policies/

The big picture problem is - 'What constitutes a fair and balanced panel for a study to determine clinical diagnostic criteria for a specific disease?'

What is considered balanced by the IOM is the panel that they have currently working on a definition for CMI (previously known as GWI. On that panel, out of 13 members, they have a few who are IOM members, a few who are pshychologists and/or psychiatrist and at most three who have some experience with Gulf War Illness veterans. This constitutes a fair and balanced panel in the eyes of the IOM and as their policy states, the IOM is the final judge of that.

Finally, it is essential that the work of committees that are used by the institution in the
development of reports not be compromised by issues of bias and lack of objectivity. (Questions
of conflict of interest are separately addressed below.) Questions of lack of objectivity and bias
ordinarily relate to views stated or positions taken that are largely intellectually motivated or that
arise from the close identification or association of an individual with a particular point of view or
the positions or perspectives of a particular group.

As Erica Verillo so eloquently stated in her article on Pro Health:

"A redefinition of CFS as “chronic multi-system illness,” or any other meaningless concatenation, will not improve upon the current definition, it will not lead to effective treatment, it will not increase funding for research, and it will not lead to acceptance by the medical community. Instead, it will usher in the widespread dismissal of ME/CFS as an organic illness, and cause a halt in meaningful research. As the experts have rightly pointed out, “this effort threatens to move ME/CFS science backward by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable. ME/CFS patients who have been disabled for decades by this devastating disease need to see the field move forward and there is no time to waste.”

 

[Andrew]

Per my telephone discussion with IOM, the three-day deadline was an artificially short deadline to send a message that they were serious about needing these. The deadline was actually later. In some settings this kind of strategy makes sense, but in this circumstance it was counter-productive.

 

[Ecoclimber]

I understand why this is pissing people off. But it is also true that IOM has no obligation to make a public open call for nominations. They do not operate under the same restrictions as CFSAC.

Is this a violation of contractual obligation or a procedure that was violated under a mandated regulation? If we don't know, why don't we know? How can we formally lodge complaints with the appropriate authorities that have jurisdiction over the contract if we don't what's contractually allowed and what isn't ? I'm not monitoring this process as I am engage elsewhere. I was hoping that those who have a legal background would be doing this as matter of agressive monitoringfor the patient community.

Another issue or bone of contention, if they are bringing in NICE criteria which was established under UK law and statue, I would assume they would be required to notifiy the UK ME advocacy organizations and groups? Wouldn't you? Bringing in NICE criteria from another country, is this legal under U.S. statute or law specifically the 'due process clause in the 14th Amendment of the U.S. Constitution? Will U.S. citizens be bound by criteria established by a foreign jurisdiction? If so then wouldn't you be required to ask for nominations from those advocacy groups in the UK as well since this could bring in PACE?

The more I dig into this legally, the more questions I have!!

 

[jspotila]

Is this a violation of contractual obligation or a procedure that was violated under a mandated regulation? If we don't know, why don't we know? How can we formally lodge complaints with the appropriate authorities that have jurisdiction over the contract if we don't what's contractually allowed and what isn't ? I'm not monitoring this process as I am engage elsewhere. I was hoping that those who have a legal background would be doing this as matter of agressive monitoringfor the patient community.

Another issue or bone of contention, if they are bringing in NICE criteria which was established under UK law and statue, I would assume they would be required to notifiy the UK ME advocacy organizations and groups? Wouldn't you? Bringing in NICE criteria from another country, is this legal under U.S. statute or law specifically the 'due process clause in the 14th Amendment of the U.S. Constitution? Will U.S. citizens be bound by criteria established by a foreign jurisdiction? If so then wouldn't you be required to ask for nominations from those advocacy groups in the UK as well since this could bring in PACE?

The more I dig into this legally, the more questions I have!!

I've filed a FOIA for the contract documents, but it will be awhile before I get them.

I am not aware of any requirement - contractual or statutory - that requires IOM to issue a public call for nominations the way CFSAC must.

Bringing in NICE criteria does not trigger any requirements to notify UK groups, nor does it raise any due process considerations. It's published in the literature. They don't have to notify every journal or author that they are looking at their publications, so I see no reason using the NICE criteria would create such an obligation. Just because something is published overseas does not create special obligations, either. How could they use anything from the BMJ or similar journals if it did? From a policy perspective, it makes no sense.

No guarantee I'm right about any of this. I'm not able to practice law, I have no special expertise in federal contracts, and I don't have access to all the materials.

 

[Ecoclimber]

I've filed a FOIA for the contract documents, but it will be awhile before I get them.

I am not aware of any requirement - contractual or statutory - that requires IOM to issue a public call for nominations the way CFSAC must.

Bringing in NICE criteria does not trigger any requirements to notify UK groups, nor does it raise any due process considerations. It's published in the literature. They don't have to notify every journal or author that they are looking at their publications, so I see no reason using the NICE criteria would create such an obligation. Just because something is published overseas does not create special obligations, either. How could they use anything from the BMJ or similar journals if it did? From a policy perspective, it makes no sense.

No guarantee I'm right about any of this. I'm not able to practice law, I have no special expertise in federal contracts, and I don't have access to all the materials.

So what I hear from you then, is that if the CDC post on their website that the treatment protocol in the physician toolkit for ME/CFS is now PACE, you would have no problem with that from a legal standpoint?

I understand you are tapped out. I don't have the bandwidth to investigate the IOM. If they can read scientific journals published outside the U.S., can they seat non U.S.scientists from outside the jurisdiction of the U.S as well? What criteria do they use to avoid conflict of interests from research funded by the insurance industry?

You did take ownership over this whole situation and I realize that you don't have the resources or bandwidth to really thorughly investigate this situation. But if certain advocates who take the middle road and state we can monitor the process, is that just an illusion since they do not have the leagl expertise, knowledge or understanding to really back up thier words? Are they giving false hope to the patient community?

I know for a fact through my own brief investigation of the IOM, it is stated through their literature that one of thier main policy directives is to move the health industry from a symptom based criteria to an evidence based criteria.

Of course this does not apply to the psychiatric industry...cough, cough....as it still is based on symptoms based psychogenic disorders not verifiable through the scientific method or evidence based criteria. The DSM-V manual proves that quite readily.

I have a problem in the duplicity of the IOM in which they speak out of both sides of the mouth by discarding medical research which they consider insufficient evidence based material as evidence by lack of verifiable medical lab results ( one day PEM vs. 2 day PEM) and yet allowing research in from the symptom based community that ME/CFS is caused by early sexual abuse http://www.cdc.gov/cfs/news/features/childhood_adversity.html or improper potty training from 'research' based on improper patient cohort selection and not backed as the IOM declares, with verifiable evidence medical criteria.

You can't have it both ways but this is exactly what the IOM as repeatedly stated especially in reference to their conclusion in the VA IOM contract!! And, this is where the danger lies for this patient community.

 

[jspotila]

So what I hear from you then, is that if the CDC post on their website that the treatment protocol in the physician toolkit for ME/CFS is now PACE, you would have no problem with that from a legal standpoint?

Well, I really can't explain how you heard something I didn't say.

. . . What criteria do they use to avoid conflict of interests from research funded by the insurance industry?

They presumably use the same procedure and criteria they use for other conflicts of interest.

You did take ownership over this whole situation and I realize that you don't have the resources or bandwidth to really thorughly investigate this situation. But if certain advocates who take the middle road and state we can monitor the process, is that just an illusion since they do not have the leagl expertise, knowledge or understanding to really back up thier words? Are they giving false hope to the patient community?

I assume ownership for my own opinions and what I say on my blog. One of my goals is to provide clear, accurate information on things that no one else is researching, like the applicability of the Federal Advisory Committee Act or like obtaining the IOM conflict of interest policy. I do my best within my limitations, and I try to do better every day. I cannot and do not answer for any advocates other than myself.

 

[Ember]

Bringing in NICE criteria from another country, is this legal under U.S. statute or law specifically the 'due process clause in the 14th Amendment of the U.S. Constitution? Will U.S. citizens be bound by criteria established by a foreign jurisdiction?

They would be if the Canadian Consensus Criteria were adopted.

 

[Ecoclimber]

Well, I really can't explain how you heard something I didn't say.

They presumably use the same procedure and criteria they use for other conflicts of interest.

hear meaning not literally but speculating based on your previous answers and assumptions given, would you be opposed to adding PACE to the physicians toolkit if it came in under the IOM treatment guide which I believe is a legitimate question? I would like to know your answer.

@Ember I guess I have to be more precise in the words used. If Nice brought in Pace as a treatment option this would require payment in many cases by taxpayer funding. This would be the difference. Of course you could make the same argument with CCC but CCC would be evidence back by scientific method used in research with verifiable medical results which the IOM should not be opposed to according to their policy directive.

I have absolutely very limited background information on NICE or PACE. Only the fact that it has managed to be a raging 'hot' topic in the PR patient community with 118 pages on the PACE trial thread and I only read about the interesting vebal sparring or duel between Lady Mar and White, Wessely, Sharpe etc.

 

[alex3619]

These are nominations for CFSAC.

Oops, will delete my post then. Darn. Just woke up.