Pandora States IOM Contract Cannot Be Stopped!

[Ecoclimber]

Pandora posted on their site:​

IOM Contract Cannot Be Stopped!​

There is a misunderstanding with regards to item 1.) within Pandora's statement:
A contract can be stopped under the following conditions:
1. Filing a lawsuit for Injunctive Relief
2. Presidential intervention or intervention from the White House Staff
3. Government Procurement in Times of Fiscal Uncertainty, the government may terminate or end a contract at any time whether it is for the convenience of the government. See: https://tinyurl.com/l3oubfs


Remember:
Congress does not have power over administrative decisions within the Executive Branch other than the threat to cut off funding for these agencies.


Caveat this is Pandora's versions of events which have not been verified.

About the IOM Procedures and Policies​

We were given a packet of general information about the IOM and their processes. We were also given some details of the ME/CFS contract. Now that our board has been informed, we are sharing with the public what wewere told about the IOM contract:

1.) The contract has been signed, funded and money is already being spent on the work. The legally binding contract cannot be stopped.

2.) At the time we were there, the study director had not been hired, but junior staff had been assigned and had already been doing research and a director was expected to be hired within days. We do not know nor have we inquired if the study director has been hired since then.

3.) The cost of the study is around $1 million. The information of who funded the study is public, but we did not inquire as to where we could find that information.

4.) The agency or agencies paying for the study is kept at “arm’s length” and not involved in the study except receiving reports that announce only the basics, such as when a meeting occurred and when the next meeting is.

5.) The ME/CFS definition committee is a consensus committee. This means that they will examine all the relevant studies, listen to public presentations and try to come up with a 100% consensus. If a committee member cannot agree with the majority, then in the report, they can write a dissenting opinion, but all work hard to come to agreement as this is most helpful in giving direction to the agency paying for the study.

6.) There are five meetings planned, two public and three private. The first will be private and more of an organizational meeting.

7.) At this point, the second meeting is planned to be open to the public, where the public, patients, patient organizations and medical professionals, including ME/CFS experts, can make a case of their position or research findings on the issues to be decided by the committee.

8.) Another public meeting, for public input, is planned, but when that will be is not yet determined. The other two meetings will be private for a free flow of discussion
,freedom to express opinions and freedom to change their mind. While the order may change, forsure, two meetings will be public and three will be private.

9.) All drafts of the report are confidential until the end of the process, and committee members are not allowed to discuss the nature of committee meeting discussions until after the report is finished.

10.) The report will go through an independent external review process.

11.) The whole process is expected to take 18 months with the last meeting addressing how to best disseminate the consensus definition to the medical professional community.

Here is what we learned about the standards and process for selecting committee members: ​

1.) Committee members are not paid for their work on an IOM committee. Their lodging, travel and meals while at the meeting are paid for. This lack of reimbursement for time often leads to private practice clinicians declining to serve, meaning professors, researchers and others with income not tied to their -time make up most of their committees.

2.) The IOM looks for individuals to serve who do not have a strong bias and do not have a financial conflict of interest (ex. their income is largely dependent on the agency funding the study). This is because they want the evidence (research studies and facts presented at the public meetings) and reasoning to be the basis for their conclusions.

3.) They look to many sources for nominations. First they contact their own members, as the IOM is a nonprofit organization of many medical professionals. They may ask their own member to serve or ask that person to nominate someone. They also ask for and welcome outside organizations to make nominations.

4.) They will post on their website the intended committee members for the public to comment on whether they have a bias or conflict of interest.

5.) Committee members understand and agree to serve representing themselves and their expert opinions, not the policy or interests of an organization, agency or institute they work for.

​

Finding Out the Options and Learning from History.​

Also while in Washington D.C., we sought the advice of a Gulf War illness advocate on these matters. His advice matched what we were told by another long-time and very involved Gulf War illness advocate who has seen the IOM do ten studies on that illness.

That advice is: You can’t stop the contract, but make sure you have the right kind of experts on the committee. Don’t wait and try to fix it afterward!

These advocates tell us that they did not realize who was on the current Gulf War illness committee until after the members were appointed.

They also tell us they gave a presentation in the April committee meeting saying there needed to be more neurologists, endocrinologists, immunologists and clinicians who specialize in the disease on the committee.

Since then, the IOM added another neurologist to the committee. Also, no conclusions have been formed and no report has been released. The committee is still doing the study.

These Gulf War illness advocates also tell us that from the beginning, they were against an IOM study on Gulf War illness treatments because it was a waste of money because patients know there aren’t any effective treatments. And they were not happy with the report.

These advocates also told us that of the nine studies the IOM has completed on Gulf War illness, one came out very good in the view of the patients. This was the 2010 report on health effects from serving in the Gulf War.

For the studies they don’t like, these advocates tell us much of the problem was the way the VA wrote the contract. They put much of the blame on the VA.

 

[Ecoclimber]

Continuation

Also, after the expert letter with 35 signatures came out late on Sept. 23, we noticed this was only a few hours after the details of the IOM contract was announced on the same day, meaning the letter was clearly written and most experts signed it before they knew the details in the IOM contract.

So, it was not surprising to hear of one of the experts changing her position publicly and at least one other tell us privately that he has changed his position. We haven’t spoken to all of them, so we don’t know how many others have changed their position after learning the details of the IOM contract or how many stand by the letter despite learning the details of the IOM contract.

We also note that the International Association of CFS/ME did not sign the letter as an organization, although some board members did and others did not. We also were informed of other ME/CFS experts who did not agree with the letter and did not sign it, because they think the IOM has the opportunity to solve the current definition disputes. Therefore it is now not clear what the majority of our experts think on the issue of the IOM contract.

We also note that Dr. Nancy Lee, the Chronic Fatigue Syndrome Advisory Committee designated federal officer, said that in a meeting with Secretary Kathleen Sebelius, the secretary said she will not dictate a particular definition for the disease because it must come from the medical community. Similarly, Dr. Elizabeth Unger of the CDC has said repeatedly that they will not embrace a definition unless it is based on data and a study
.
Evidently, in their eyes, the 2003 CCC does not meet those standards and something else besides demanding it be adopted is needed to make that happen.

When we asked the IACFS/ME if they would take the lead in making the 2003 Canadian Consensus Criteria be more widely recognized and accepted by the CDC and other medical professional organizations or have a workshop to develop a definition that is based on biomarkers, has subgroups, includes measures to designate those with severe functional limitations and replaces the “chronic fatigue syndrome” name, we were told they do not have the time, energy or funds to do that.

When we asked some of the 35 signatories of the expert letter what next step they have planned to get the CDC and medical professionals in general to embrace the 2003 CCC, we were told there isn’t any. This leaves us with no leadership or initiative on the definitions, and no opportunity to reach our goals except the risky IOM study.

The Request Comes

While in Washington D.C. attending many different meetings, we received an email from the IOM asking us to make nominations to the ME/CFS definition committee. In our understanding, we were not the first organization contacted, and we told them about the New Jersey CFS Association, one they did not know about. We were given very short notice, only three days, during which our president had limited availability due to other meetings in Washington D.C. and flying back home.

When presented with new developments, we gather the facts as best we can find out, seek advice, decide executively or within the board of directors as a whole, make sure the directors are aware of the decisions made and then we inform the public.

We sought guidance from our public policy advisor, Prof. Kenneth Friedman, and we considered the position of our medical advisor, Dr. Andy Kogelnik. We also realized that the science of the biological mechanisms of ME/CFS is much stronger now than it was in 1994 or even 2003, and it is much stronger than what is currently available for Gulf War illness.

In considering what to do, we asked the following questions:
Since all indications are the contract is unstoppable, what can we do to avoid the mistakes made by many of the Gulf War illness advocates? How can we hold the IOM accountable for the committee members the IOM selects and the results of the study if we don’t tell them who our experts are when they ask us?

Since the process for selecting the members is underway, what will most likely help the patients, a study done by a committee that includes our experts or one that has members that do not have the expertise needed?

How can we say we support our experts when we know a committee is being established on this disease (whether we like it or not) and when given the opportunity, we didn’t nominate any ME/CFS experts?

We realized that if we do not work to put our experts on the committee, we will create the very thing we are against: non-ME/CFS experts deciding how to define the disease. It will be us to blame then and not the IOM or the government.

Therefore, we decided to turn in a list of expert nominations. And we have since learned of at least four other organizations that turned in nominations.

Does this mean we support the IOM contract? No. We are eager to assist the experts if they independently or through a medical professional organization take the lead in solving the lack of definition consensus in the expert and medical community at large through a workshop, a study or other means.

However, we have been told this option is not available and just demanding it without a study or workshop has not and will not work.

What our nominations to the IOM does mean is that we support our ME/CFS experts, who are the only ones with the knowledge and expertise to determine an appropriate disease definition. It means we will do all we can to avoid an IOM definition disaster given the choices before us because our focus is on what is best for the patients. We also will be monitoring closely to make sure the committee members are ones who can view the science objectively.

We will voice our opinion before the committee members are appointed if they are not suitable. We will give a presentation during the open meeting section that clearly shows that fatigue is a symptom, not a disease.

We encourage our experts and others to give presentations or make comments. We will be sending the IOM the research studies that the committee needs to consider, particularly those about biomarkers.

Also, now, as always, we will be as transparent as we can be while also being prudent and strategic. Before we announce our actions or decisions to the public on important advocacy matters, we find out the facts, seek out advice from those with experience and involve our board by either asking for their input or informing them of the executive decision.

In harmony with our policies, we are now informing you here of the names we turned in as nominees to the committee. We urge other ME/CFS organizations to do the same. We have not recruited these experts to serve or even spoken to these experts to see if they are willing to serve or if they have a bias that would prevent them from being objective or if they have a conflict of interest.

Because of the deadline given and other meetings in Washington D.C. and time to travel home, we had only one day to get the advice of our public policy advisor and formulate the list and turn it in. The IOM will recruit the committee members because that is their job.

 

[Ecoclimber]

Pandora Nominations for ME/CFS Committee​

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
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

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


It's interesting that Dr. Cheney, Dr. Lerner, Dr. Komaroff, Dr. Shepard, Dr. Chia, Dr. Natelson names are not included. I didn't see them at first glance, thanks Andrew

 

[Seven7]

IS this the official nominee list on the IOM??? I am releived then.

 

[Andrew]

Thanks for posting this. FWIW, Chia and Natelson are on the list.

 

[Ecoclimber]

IS this the official nominee list on the IOM??? I am releived then.

These are Pandora's nominations. Nominating and actually being on the panel are two different processes.

 

[Ruthie24]

Thanks for posting. It's good to know there is someone with a finger on the pulse in DC who knows what's really going on. While I've been signing petitions and sending emails, posting on facebook etc, it feels so hopeless when I know nothing about advocacy and there doesn't seem to be anyone at the top who is coordinating things. This at least feels like someone is trying to make the best of a bad situation.

Really hoping we'll see many of these names on the actual panel list!!!

Watching and reading the transcript of the video presentation by the Gulf War Veteran that was posted, it does seem to reflect what PANDORA states above...that much of the blame for the IOM's results seems to lie more with the VA than the IOM perhaps. Seems like the original IOM report in 2010 was actually strongly in favor of the pathological nature of the disease until the VA changed things. Subsequent IOM reports were clearly not as favorable but seem to have been pressured by VA unless I'm reading it wrong.

 

[Ecoclimber]

Thanks for posting. It's good to know there is someone with a finger on the pulse in DC who knows what's really going on. While I've been signing petitions and sending emails, posting on facebook etc, it feels so hopeless when I know nothing about advocacy and there doesn't seem to be anyone at the top who is coordinating things. This at least feels like someone is trying to make the best of a bad situation.

Really hoping we'll see many of these names on the actual panel list!!!

Watching and reading the transcript of the video presentation by the Gulf War Veteran that was posted, it does seem to reflect what PANDORA states above...that much of the blame for the IOM's results seems to lie more with the VA than the IOM perhaps. Seems like the original IOM report in 2010 was actually strongly in favor of the pathological nature of the disease until the VA changed things. Subsequent IOM reports were clearly not as favorable but seem to have been pressured by VA unless I'm reading it wrong.

It raises th question as to whether the HHS contract is any different than from the VA IOM Contract. Once the contract is awarded, the contracting agency is excluded from the IOM decision making process. We can nominate various ME/CFS members but is there anywhere in the contract stating who makes the final decision on board members and how many nominating members are required to be seated? If the panel is made up of 18 members for example and we have only 2 members on it, out interests will get voted out everytime. This is what happened to the veterans. A process of smoke and mirrors.

3.) They look to many sources for nominations. First they contact their own members, as the IOM is a non-profit organization of many medical professionals. They may ask their own member to serve or ask that person to nominate someone. They also ask for and welcome outside organizations to make nominations.
I would say postively that most of their members either have no knowledge of ME/CFS or a predisposition that it is psychogenic in nature since that's been the view in the medical community for the last 35 years.

Dr. Elizabeth Unger of the CDC has said repeatedly that they will not embrace a definition unless it is based on data and a study. Is that a threat to the independent board?

Are of this information needs to be verified and confirmed. I am sure from the evidence, a great deal can be rebutted.

 

[Sparrowhawk]

Great to see this, thank you. While it's discouraging that the IOM is moving forward, this looks like well reasoned damage mitigation. Now we must apply our energies to insuring as many of these nominees get on the committee as possible.

 

[Ember]

It's good to know there is someone with a finger on the pulse in DC who knows what's really going on.

I don't appreciate shadowy reporting that can't be verified. Pandora reports that “it was not surprising to hear...at least one other tell us privately....” They add, “We were also informed of other ME/CFS experts who... did not sign it, because....” And they therefore conclude that “it is now not clear what the majority of our experts think on the issue of the IOM contract.”

When it comes to input from Gulf War veterans, Pandora doesn't name its sources: “We sought the advice of a Gulf War illness advocate on these matters. His advice matched what we were told by another long-time and very involved Gulf War illness advocate.”

The named sources are, once again, Dr. Lee and Dr. Unger:

We also note that Dr. Nancy Lee, the Chronic Fatigue Syndrome Advisory Committee designated federal officer, said that in a meeting with Secretary Kathleen Sebelius, the secretary said she will not dictate a particular definition for the disease because it must come from the medical community. Similarly, Dr. Elizabeth Unger of the CDC has said repeatedly that they will not embrace a definition unless it is based on data and a study.

Pandora concludes that there is now no opportunity to reach our goals except the risky IOM study:

When we asked some of the 35 signatories of the expert letter what next step they have planned to get the CDC and medical professionals in general to embrace the 2003 CCC, we were told there isn’t any. This leaves us with no leadership or initiative on the definitions, and no opportunity to reach our goals except the risky IOM study.

Here's the plan, as articulated in the open letter signed by the experts:

The expert biomedical community will continue to refine and update the case definition as scientific knowledge advances; for example, this may include consideration of the 2011 ME International Consensus Criteria (Carruthers et al, Journal of Internal Medicine, 2011)....

We strongly urge you to abandon efforts to reach out to groups such as the Institute of Medicine (IOM) that lack the needed expertise to develop “clinical diagnostic criteria” for ME/CFS....

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. We believe that our consensus decision on a case definition for this disease will jump start progress and lead to much more rapid advancement in research and care for ME/CFS patients. We look forward to this accelerated progress and stand ready to work with you to increase scientific understanding of the pathophysiology of this disease, educate medical professionals, develop more effective treatments, and eventually find a cure.

Pandora's main source seems to have been a packet of general information that IOM gave them about the organization and its processes. The Statement of Work was already in the public domain.

 

[caledonia]

http://www.research1st.com/2013/10/08/clearing-the-air/

Suzanne Vernon wants us to work with the IOM. We should do the opposite of whatever Suzanne Vernon says.

 

[Ember]

A contract can be stopped under the following conditions:
1. Filing a lawsuit for Injunctive Relief
2. Presidential intervention or intervention from the White House Staff
3. Government Procurement in Times of Fiscal Uncertainty, the government may terminate or end a contract at any time whether it is for the convenience of the government. See: https://tinyurl.com/l3oubfs

It's reassuring to read that “government contracts grant the government the right to terminate its contracts for either default or convenience, but the government has also been found to have an inherent right to terminate contracts for its convenience, regardless of whether the contract provides for this right. ” That information probably wasn't spelled out in the IOM packet of information.