IOM Report - What happens next?

[August59]

I'm having a hard time processing all of this, so my question is:

What happens next? Does it just need NIH/HHS blessing? What's the chances of the IOM report being revised or completely dismissed by NIH/HHS? Could the patient/medical community still have any input (such as: revising the report. Or, requesting budget recommendations.)

Thanks

 

[WillowJ]

It is intended to be published in peer-reviewed publications. Or the short articles already published were that? I lost the script.

I plan to use this to give to my elected officials. Being able to quote something stamped with the "National Academy of Sciences" which calls attention to the lack of funding and says the disease is important and real should help. Whatever NIH is thinking, having Congress breathing down their necks can't hurt.

The economic losses will be important to Congress. Surely if there is some attention to the disease, those would eventually ease. We feel that it is treatable because some of us do get better with treatment or spontaneous better spells.

Congress typically doesn't like to make "science" and "medical" decisions, but here everything has been evaluated and explained for them by a "proper" authority. They should have an aide who can read a very long medical brief.

Anyone can write their congresspeople, but particularly if you have one on a key committee

Examples:

http://waysandmeans.house.gov/about/members.htm

Rep. Kevin Brady, TX, Chairman

Rep. Sam Johnson, TX
Rep. Devin Nunes, CA
Rep. Peter Roskam, IL
Rep. Tom Price, GA
Rep. Vern Buchanan, FL
Rep. Adrian Smith, NE
Rep. Lynn Jenkins, KS
Rep. Kenny Marchant, TX
Rep. Diane Black, TN


Rep. Jim McDermott, WA, Ranking Member
Rep. Mike Thompson, CA
Rep. Ron Kind, WI
Rep. Earl Blumenauer, OR
Rep. Bill Pascrell, NJ
Rep. Danny K. Davis, IL

http://www.appropriations.senate.go...human-services-education-and-related-agencies

Chairman: Roy Blunt
Ranking Member: Patty Murray

Jerry Moran, Kansas
Richard C. Shelby, Alabama
Thad Cochran, Mississippi
Lamar Alexander, Tennessee
Lindsey Graham, South Carolina
Mark Kirk, Illinois
Bill Cassidy, Louisiana
Shelley Moore Capito, West Virginia
James Lankford, Oklahoma

Richard J. Durbin, Illinois
Jack Reed, Rhode Island
Barbara Mikulski, Maryland
Jeanne Shaheen, New Hampshire
Jeff Merkley, Oregon
Brian Schatz, Hawaii
Tammy Baldwin, Wisconsin

 

[Wally]

I'm having a hard time processing all of this, so my question is:

What happens next? Does it just need NIH/HHS blessing? What's the chances of the IOM report being revised or completely dismissed by NIH/HHS? Could the patient/medical community still have any input (such as: revising the report. Or, requesting budget recommendations.)

Thanks

@August59,

I don't know what comes next as far as the I.O.M. and the HHS. I tried to ask these questions during the Q&A for the Press/Public Briefing. However, my questions hung out in a "moderation" mode for over 10 minutes and then the briefing ended early because they said there were no other questions to be answered.

I yelled out at my computer - "I have questions - many questions!" I learned later that I was not alone in not having the questions I submitted being asked at the Briefing. Very strange because it appeared that receipt of my questions was acknowledged, as I received a message on my computer screen stating that my questions were waiting for moderation. I and others thought we followed the rules for submitting questions, but due to some type of technical glitch (or some other issue) our voices were silenced. Seems like this has happened to me a lot when trying to participate in one of the HHS's "Hoedowns".

I followed up with the I.O.M. by phone to tell them of the glitch with the Q&A session. No one seemed to be available to answer my call, so I left a message with my concerns/questions, along with my contact information. So far, I have not received a return call or e-mail communication from the I.O.M. :thumbdown: I will call again on Tuesday (and also send an e-mail) just to make sure that my questions reach their destination.

The I.O.M. will still be under contract with the HHS for this project through March 22, 2015. Per information provided by I.O.M. staff, comments submitted to the Committee will be accepted through the end of the contract period. I am not sure if the comments received after the Report was complete will be read by anyone on the Committee or if these comments will just become part of the Public Record for this project.

I am also trying to obtain answers from the HHS to the following questions:

1) What is the process that will be used (or has already been used) to adopt or reject the Report and any of its recommendations?

2) Who has the authority within the HHS to approve or reject the Report and its recommendations? If the HHS does not have this authority who does?

3) Will the I.O.M. Committee be developing guidelines for clinical diagnosis for this illness under its original contract or has or will a new contract(s) be entered into for this project?

4) Will an opportunity be provided for ME/CFS patients, supporters and other interested parties to meet publicly or privately with the HHS to discuss any concerns they may have with the Report and its recommendations, prior to the approval or rejection of the Report or any of its recommendations?

5) How and when will the HHS announce to the Public that the Report and its recommendations have been approved or rejected?

6) How will the HHS announce to the Public what steps it will take to implement the recommendations that it has approved from the Report?

7) Did the HHS (or one of the other "funders" for this contract) specifically ask the I.O.M. Committee to recommend a new name for this illness, if they should make a recommendation that the name of this illness be changed? Or was the I.O.M. Committee only asked for a recommendation as to whether or not a name change for this illness should be considered? If a specific request was made to the Committee for a recommendation for a new name for this illness, where in the contract or statement of work or other document was this request made?

8) Was the I.O.M. Committee required to arrive at a unanimous decision about the recommendations in the Report or could the Report have been issued with dissenting opinions?

9) Does the I.O.M. Committee have the ability to substantively amend its Report, prior to the end of the contract period?

So many questions, but will there be so many answers? I am not sure if my questions will be answered or ignored or will disappear due to a technical glitch? Fortunately or unfortunately, it really bugs me to have things left hanging. Even if I may be a little slow to get to the starting line, I will keep trying to illicit answers to these questions and let you know how things work out.

 

[taniaaust1]

Makes one wonder if the "glitches" of not being able to get questions throu were accidental or not.

 

[August59]

Glitches are like a case of bad gas! Just blame it on the dog!

 

[August59]

It is intended to be published in peer-reviewed publications. Or the short articles already published were that? I lost the script.

I plan to use this to give to my elected officials. Being able to quote something stamped with the "National Academy of Sciences" which calls attention to the lack of funding and says the disease is important and real should help. Whatever NIH is thinking, having Congress breathing down their necks can't hurt.

The economic losses will be important to Congress. Surely if there is some attention to the disease, those would eventually ease. We feel that it is treatable because some of us do get better with treatment or spontaneous better spells.

Congress typically doesn't like to make "science" and "medical" decisions, but here everything has been evaluated and explained for them by a "proper" authority. They should have an aide who can read a very long medical brief.

Anyone can write their congresspeople, but particularly if you have one on a key committee

Examples:

http://waysandmeans.house.gov/about/members.htm


http://www.appropriations.senate.go...human-services-education-and-related-agencies

Bringing this to the attention of anyone in Washington (from a US perspective) from the NIH, Congress and The White House certainly can't hurt. NIH and Congress need to know that there's a "new disease" that desperately needs funding. NIH proposes a budget, but as always Congress holds the purse. They're going to be stingy with it to, so we need to remind them of the priorities of their constituents!

 

[WillowJ]

someone said something about magic language for people with needs that are not being addressed. Does anyone know what this is?

 

[Kati]

While reading the report, and making sure that it said the right things which essentially I think it did, is one step, the most important next step is indeed the response from HHS and this response will be quite telling.

In my opinion they have no choice to respond with a substantial money figure, in the light of this report and the impending final report of the P2P (which we all hope will make mention of the missing 'lack of funding' terminology we all wrote about in our responses.)

It would be an embarrassment for them if they decided not to fund research because the good papers will keep on coming and the questions to them will be more and more pressing.

 

[Wally]

@August59,

I don't know what comes next as far as the I.O.M. and the HHS. I tried to ask these questions during the Q&A for the Press/Public Briefing. However, my questions hung out in a "moderation" mode for over 10 minutes and then the briefing ended early because they said there were no other questions to be answered.

I yelled out at my computer - "I have questions - many questions!" I learned later that I was not alone in not having the questions I submitted being asked at the Briefing. Very strange because it appeared that receipt of my questions was acknowledged, as I received a message on my computer screen stating that my questions were waiting for moderation. I and others thought we followed the rules for submitting questions, but due to some type of technical glitch (or some other issue) our voices were silenced. Seems like this has happened to me a lot when trying to participate in one of the HHS's "Hoedowns".

I followed up with the I.O.M. by phone to tell them of the glitch with the Q&A session. No one seemed to be available to answer my call, so I left a message with my concerns/questions, along with my contact information. So far, I have not received a return call or e-mail communication from the I.O.M. :thumbdown: I will call again on Tuesday (and also send an e-mail) just to make sure that my questions reach their destination.

The I.O.M. will still be under contract with the HHS for this project through March 22, 2015. Per information provided by I.O.M. staff, comments submitted to the Committee will be accepted through the end of the contract period. I am not sure if the comments received after the Report was complete will be read by anyone on the Committee or if these comments will just become part of the Public Record for this project.

I am also trying to obtain answers from the HHS to the following questions:

1) What is the process that will be used (or has already been used) to adopt or reject the Report and any of its recommendations?

2) Who has the authority within the HHS to approve or reject the Report and its recommendations? If the HHS does not have this authority who does?

3) Will the I.O.M. Committee be developing guidelines for clinical diagnosis for this illness under its original contract or has or will a new contract(s) be entered into for this project?

4) Will an opportunity be provided for ME/CFS patients, supporters and other interested parties to meet publicly or privately with the HHS to discuss any concerns they may have with the Report and its recommendations, prior to the approval or rejection of the Report or any of its recommendations?

5) How and when will the HHS announce to the Public that the Report and its recommendations have been approved or rejected?

6) How will the HHS announce to the Public what steps it will take to implement the recommendations that it has approved from the Report?

7) Did the HHS (or one of the other "funders" for this contract) specifically ask the I.O.M. Committee to recommend a new name for this illness, if they should make a recommendation that the name of this illness be changed? Or was the I.O.M. Committee only asked for a recommendation as to whether or not a name change for this illness should be considered? If a specific request was made to the Committee for a recommendation for a new name for this illness, where in the contract or statement of work or other document was this request made?

8) Was the I.O.M. Committee required to arrive at a unanimous decision about the recommendations in the Report or could the Report have been issued with dissenting opinions?

9) Does the I.O.M. Committee have the ability to substantively amend its Report, prior to the end of the contract period?

So many questions, but will there be so many answers? I am not sure if my questions will be answered or ignored or will disappear due to a technical glitch? Fortunately or unfortunately, it really bugs me to have things left hanging. Even if I may be a little slow to get to the starting line, I will keep trying to illicit answers to these questions and let you know how things work out.

Update - I have talked with IOM Staff assigned to the MECFS Project/Report. They are aware of the "technical problem", which occurred at the Press/Public Briefing for the release of the report, where questions were not answered by the Committee members. This was apparently a technical problem resulting from a third party contractor who was hired to handle the broadcast/online Q&A.

IOM Staff did discuss this problem with the Committee and asked whether there could/would be a follow-up communication by the Committee to answer these questions. The answer to this question was no.

I also asked if any questions/comments received by the Committee through their Public Comment e-mail box (which will remain open thru 3/22/2015 - end of contract period) will be responded to before the end of the contract period. The answer to this question was no.

Please note that I have filed a P.A.R. for the Public Comments submitted to the I.O.M. Committee. This request was responded to and I am in the process of reviewing those documents. A second P.A.R. request will be submitted to cover the period through the end of the contract period.

Copies of the IOM Public Comments, as well as copies of the Public Comments to the NIH's P2P Draft Report (which have also now been received), are anticipated to be hosted for viewing at MEadvocacy.org.

I am in process of reviewing each document that I have received to determine that no personally identifiable information (i.e. e-mail addresses, phone numbers etc...) for any individual, not identified as commenting as part of an organization, appears on these documents when posted for viewing.

An announcement will be made when the documents are ready for viewing.

 

[Iquitos]

While reading the report, and making sure that it said the right things which essentially I think it did, is one step, the most important next step is indeed the response from HHS and this response will be quite telling.

In my opinion they have no choice to respond with a substantial money figure, in the light of this report and the impending final report of the P2P (which we all hope will make mention of the missing 'lack of funding' terminology we all wrote about in our responses.)

It would be an embarrassment for them if they decided not to fund research because the good papers will keep on coming and the questions to them will be more and more pressing.

Those governmental organizations have no obligation, other than the moral one, to accept and/or act upon the IoM's recommendations. I found several other past IoM reports that the relevant governmental bodies have chosen to just ignore.

One was a study that ended up recommending decriminalization of marijuana -- back some 10 years ago. Another was, incredibly, a study on whether pregnant and nursing women should be able to buy potatoes with their WIC awards. Both ignored by the US government.

Based on previous behavior from HHS, they are not capable of being embarrassed by not funding research for a disease that affects twice as many ME patients than the number of MS patients. All that research money going for male pattern baldness, erectile dysfunction and hay fever is very telling about where their priorities are.

We need a Congressional Mandate demanding a minimum of $150 million in research funding per year until this disease has a cause and a treatment found.

 

[meadowlark]

One was a study that ended up recommending decriminalization of marijuana -- back some 10 years ago. Another was, incredibly, a study on whether pregnant and nursing women should be able to buy potatoes with their WIC awards. Both ignored by the US government.

That's very discouraging, as Sanjay Gupta's reporting on medical MJ made it clear that the government has always been completely opposed to funding studies into the use of marijuana for pain. He also said that “The U.S. holds a patent [on marijuana] on one hand, and on the other hand, the same government says it has no medical applications. Journalists are trained to hate hypocrisy. This is hypocrisy. I’ve never seen it quite like this.” In light of that, what was the point of shelling out for an IOM report?

This really shakes my hope that the IOM report on our disease will embarrass them into at least throwing us a few crumbs, or crumbs from the "crumbs table." Paying the IOM is an awfully expensive way to kick the can down the road, but perhaps, along with P2P and years of patient testimony, that's been the end game all along.

 

[Iquitos]

Yes, the US government has more than one patent on components of cannabis. And Rafael Mechulam, Israeli scientist who isolated THC 50 years ago says he has received research money from the NIH for some of his later research, while American researchers have not had access to cannabis or money for research, due to the DEA and other impediments. In Israel, pharmacists sell cannabis from pharmacies, as any other prescription.

$1 million wasted on an IoM "task" is nothing in the face of this magnitude of hypocrisy. If those decision makers were capable of embarrassment, they would have died of shame long ago. All they understand and respect is power. That's why we have to get some of the powers that be to get involved and use that power for good.

 

[Ember]

This really shakes my hope that the IOM report on our disease will embarrass them into at least throwing us a few crumbs, or crumbs from the "crumbs table." Paying the IOM is an awfully expensive way to kick the can down the road, but perhaps, along with P2P and years of patient testimony, that's been the end game all along.

"It seems a shame," the Walrus said,
"To play them such a trick,
After we've brought them out so far,
And made them trot so quick!"
The Carpenter said nothing but
"The butter's spread too thick!"

 

[Wally]

Update - I have talked with IOM Staff assigned to the MECFS Project/Report. They are aware of the "technical problem", which occurred at the Press/Public Briefing for the release of the report, where questions were not answered by the Committee members. This was apparently a technical problem resulting from a third party contractor who was hired to handle the broadcast/online Q&A.

IOM Staff did discuss this problem with the Committee and asked whether there could/would be a follow-up communication by the Committee to answer these questions. The answer to this question was no.

I also asked if any questions/comments received by the Committee through their Public Comment e-mail box (which will remain open thru 3/22/2015 - end of contract period) will be responded to before the end of the contract period. The answer to this question was no.

Please note that I have filed a P.A.R. for the Public Comments submitted to the I.O.M. Committee. This request was responded to and I am in the process of reviewing those documents. A second P.A.R. request will be submitted to cover the period through the end of the contract period.

Copies of the IOM Public Comments, as well as copies of the Public Comments to the NIH's P2P Draft Report (which have also now been received), are anticipated to be hosted for viewing at MEadvocacy.org.

I am in process of reviewing each document that I have received to determine that no personally identifiable information (i.e. e-mail addresses, phone numbers etc...) for any individual, not identified as commenting as part of an organization, appears on these documents when posted for viewing.

An announcement will be made when the documents are ready for viewing.

FYI - I wanted to provide a further update on the review and publishing of documents received from the I.O.M. as part of a P.A.R. request. This review, along with a final decision on where these documents will be hosted for viewing by the public is currently underway.

The Public Comments received from the N.A.S./I.O.M. are taking considerably longer than expected to review and prepare for public viewing because almost every document contained what I consider to be publicly identifiable information that was not redacted as part of the P.A.R. request process. I am going through each document to redact this information, before I will allow the copies of documents that I received to be released for a secondary public viewing.

I am also still reviewing the documents I have received from the N.I.H. in response to my F.O.I.A. request. These documents were redacted by the N.I.H. for personally identifiable information, before being sent to me. While only having time to give these documents a quick review, my initial review did not find a comment from C.F.S.A.C. nor my own personal comment. I will be reviewing the documents in more detail to see if I missed these two documents the first time around or if they were not included with the copies that were provided to me in response to my F.O.I.A. request.