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IOM Process - four stages explained

Ecoclimber

Senior Member
Messages
1,011
We have observe the smoke and mirrors of Sebelius Affordable Care Act.

We have observe the smoke an d mirrors of Sebelius VA IOM Panel Contract.

Wehave observe the smoke and mirrors of Sebelius ME/CFS IOM Contact.

Wehave observe the smoke and mirrors of bureaucratic words with various meanings of biases.
The scientific method is not bias, it is truth. Scientific research that is based on the scientific method which results in significant breakthroughs concerning a particular illness is not bias but scientific conclusions of fact concerning cetain disease aspects of that particular illness. With over 4000 published scientific peer reviewed papers based on the scientific method, with selected CCC cohorts, they are not biases but established scientific evidence of a particular relationship, observations or effects of the illness within a particular group of patient cohorts.

To exclude data based on scientific evidence as they did with Research Advisory Committee on the VA IOM contract as bias, is nothing but a smokescreen of bureaucratic haze to obfuscate the bias that is in engrained in VA IOM Panel and will be in the ME/CFS IOM Panel.


Bringing over the participants from the VA IOM Panel insures that same policies and procedures will b adhered to guarantee the same results.
 

Ecoclimber

Senior Member
Messages
1,011
Where did IOM say they try to minimize the number of people who are researching the disease?
Research and study the actions by VA IOM Panel, SOW, Contract with the final makeup of the VA IOM Panel and the personal testimonies under oath by those who were excluded from the Panel and the decision making process including members of the RAC and you will have your answer. It really isn't that difficult. Determine if they are not following the same procedure with the same language as they did with the VA IOM Panel. You will have your answer on their tatics.
 

Firestormm

Senior Member
Messages
5,055
Location
Cornwall England
I'm going to reach out to the communications person at IOM to see if we can get more info on bias v. conflict of interest. But here is what I know:

IOM is inviting people to join the committee. They solicited nominations from ME/CFS organizations, ME/CFS advocates, and I'm assuming from other sources. Those other sources could include their own membership, prominent scientists, agencies . . . I have no idea. Just guessing. However, I know of one ME/CFS expert who has received an invitation letter. I assume there will be more than one.

Committee members are invited to serve based on their expertise and knowledge base. If you recall, the nomination solicitation (and the Statement of Work) listed a number of areas of expertise. I think it is reasonable to assume that not all the members will be ME/CFS experts, and of course our worst case scenario is that there are only one or two. IOM is well aware of how we will perceive a committee with only one or two experts. I told them, and I know others have as well.

Committee members are NOT chosen to represent an organization, a group, or their own research interests. They are asked to use their expertise and knowledge base to evaluate the evidence and draw their own conclusions. This is how I was trained for FDA as well: you must evaluate all the evidence fairly, apply your expertise, listen to the other committee members and arrive at your own conclusions.

From what I can tell, the committee can invite specific people to speak at the public meetings. I think one of the GWI case definition public meetings earlier this year included panels, and I assumed those panelists were invited to speak. I think they also accept general comment, but that is determined by each committee.

The provisional committee list will come out the end of November or early December. We will have only twenty days to respond. I think it is vitally important that we do, and that we raise any and all concerns we have about committee members' biases, conflicts of interest, connections to insurance companies, etc. I've started compiling the names that organizations have been willing to share with me (which is by no means all of them), and my intention is to turn around background information very quickly when the slate comes out. It means doing in depth research into backgrounds in a 24 hour window and then writing up summaries to share with the community. I could use help, so if you are able to do detailed research and writing in such a short window (that we don't know when it will occur!) please email me at jspotila@yahoo.com.


I think 'experts' will be solicited for areas relating to the operationalisation of clinical diagnostic criteria, and for 'alternate' diagnoses, and tests etc. Some non-ME experts will be considered essential. I am never clear on the experise of the IOM itself - I know this has been raised as a concern before - and I don't mean in regard to our specific condition: but I mean in relation to making these kind of recommendations. They do seem to lack experience. Then again, perhaps, at least in part this explains their reference to NICE who have of course published many clinical guidelines.
 

Andrew

Senior Member
Messages
2,513
Location
Los Angeles, USA
When I was diagnosed with prostate cancer, my first thought was NOT "hey, I better go out and find a urologist who has the least amount of experience with cancer because he will be less biased." What I did was find a urologist whose specialty is prostate cancer. I also found an oncologist who only works with prostate cancer. And I'm sure both of them have their own biases. But so what. Who doesn't have a bias. Every expert and non-expert has a bias. But at least an expert has a well-informed bias.

Let me ask you this. If one of your family members was sick with a debilitating illness, would your first choice for a solution be someone with no experience.

I'm sure the people at the IOM are intelligent and know how to read journal articles. But consider this. There are over 3000 journal articles. Do you really think every non-expert is going to sift through these. Do you think they will even bother to differentiate between Oxford Criteria Studies and Fukuda studies. If you do, name one non-expert major medical institution that does. I'm waiting to hear your answer.

Now, maybe you are thinking "well, all we have to do is inform them what Oxford really is." Okay, fair enough. Show me one instance where this has worked. Show me one case of a major medical institution who has modified their website or information packet after being informed by advocates. I'm waiting to hear your answer.

What the people at the IOM will do is look a smattering of research. They will make a decision based on the evidence. They will disregard the fact that most of the evidence was found using weak definitions, like Fukuda or Oxford. They will ignore the fact that you can't take weak research to create a strong definition. To do that you need to use observational science based on years of first hand experience working with patients. And they don't have this experience. But they will form an opinion in the complete absence of direct personal observation, direct examination of patients, and no field testing of the criteria.

Is this what you want?
 

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
There is no doubt the IOM will be deluged with testimony and research involving the crtical issues. Its how those issues are weighted and given priority that is important. The pattern has been clear for a decade. Strong nonscientific promotion of psychogenic views, poor Cochrane reviews of these issues, a failure for medicine to grapple with unfounded psychiatric diagnoses, and the supposed evidence-base of many RCTs in CBT and other areas in psychiatry that rely on unproven diagnoses and subjective results that are within a potential bias range.
 

justinreilly

Senior Member
Messages
2,498
Location
NYC (& RI)
Where did IOM say they try to minimize the number of people who are researching the disease?

I took that from the PANDORA paper on nominations, relaying what they were told by an IoM representative.
http://www.pandoraorg.net/uploads/Position_on_IOM_Request_for_Nominations.pdf
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.

Plus all the talk on the IoM website about favoring IoM members, past IoM panelists (eg Buchwald, Vernon and Friedberg), younger people, minorities, women and people "who might not otherwise collaborate" from a diverse range of specialties, and needing to "balance" the committee. And the language in the statement of work is pretty weak on including ME experts.
 
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justinreilly

Senior Member
Messages
2,498
Location
NYC (& RI)
@Andrew, Your comment really makes crystal clear the problem here. I wish everyone could see your comment! Everyone Pls repost his comment where appropriate.

We need to remind people, to ask them those great questions-
- If you had prostate cancer, would you go see a top-rated knee surgeon or even a great urologist with no cancer expertise?
- What non-ME major medical organization has ever put out substantially accurate info on ME or even bothered to differentiate between Oxford, Reeves, Fukuda and CCC studies?
- What organization has changed their website or other information after being made very well aware of the problems by advocates?
- Look how hard it was to even get a CFS org like CAA to take down Peter White's picture and piece he wrote on the great benefits of CBT and GET. And they're supposed to be representing us.

The fact is we have no chance with non experts, even well meaning ones.

I have looked through (and reviewed on Amazon and elsewhere) about 200 medical textbooks that should or I thought would have something on ME. Probably half had nothing, half had substantially inaccurate (and usually tiny) pieces on "CFS" and two had substantially accurate information. One was a chapter by Charles Lapp on ME in a textbook. I forgot what the other one was. I think it was a very short, generally accurate piece in a general text.

Two out of about 200. And among non-expert (and Wessley school) authors, one out of 200.

Do you like those chances? One out 200 for getting it right?

And this was for just drafting a short description of the disease, much less coming up with an entirely NEW ACCURATE DEFINITION, which is much, much more difficult.
 
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Ecoclimber

Senior Member
Messages
1,011
Has anyone investigated whether HHS award or contract with the IOM violated any Code of Federal Regulations and since SS is involved, are there any exclusions for medicare and medicaid with the OIG? Has HHS violated any Federal Procedures in procurement, notification, the entire process under HHSAR? http://www.hhs.gov/regulations/hhsar/tocindetail.html http://www.hhs.gov/ohrp/. Were they required by law to make it a competitive bid or could they have the authority to award the contract to the IOM?
 

jspotila

Senior Member
Messages
1,099
Has anyone investigated whether HHS award or contract with the IOM violated any Code of Federal Regulations and since SS is involved, are there any exclusions for medicare and medicaid with the OIG? Has HHS violated any Federal Procedures in procurement, notification, the entire process under HHSAR? http://www.hhs.gov/regulations/hhsar/tocindetail.html http://www.hhs.gov/ohrp/. Were they required by law to make it a competitive bid or could they have the authority to award the contract to the IOM?

FWIW, I did some basic investigation into whether the procedures around this contract violated federal law. They did not, as far as I can tell. They were not required to make it a competitive bid process.

That's not to say my research is definitive. I am not an expert on federal contracting, nor do I know all the places to check for regulations, etc.
 

Nielk

Senior Member
Messages
6,970
FWIW, I did some basic investigation into whether the procedures around this contract violated federal law. They did not, as far as I can tell. They were not required to make it a competitive bid process.

That's not to say my research is definitive. I am not an expert on federal contracting, nor do I know all the places to check for regulations, etc.

Except for the GWI current study for a definition, is there a precedent as to HHS hiring an outside private venue with the charge of redefining a disease? This might be a completely new territory.
 

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
I don't know about hiring outside sources, but contracting the IOM to produce guidelines etc. is the purpose of the IOM's existence, and the HHS has been doing this for a very long time. At least that is my current understanding.

The issue though is whether this kind of process has credibility with so much bad research that has been uncritically received, poor definitions in the first place leading to poor research, and in trying to come to grips with something that currently has no definitive biomarkers. Whether they consider the markers we already know about to be sufficient is a critical question, but I doubt they will.

If ME and CFS were diagnostic areas with well defined biomarkers, a generation or more of well funded quality research based on a fairly robust definition, and a wide diversity of quality clinical intervention trials, then the issue would be simple. Sadly that is not what exists.
 

Nielk

Senior Member
Messages
6,970
I don't know about hiring outside sources, but contracting the IOM to produce guidelines etc. is the purpose of the IOM's existence, and the HHS has been doing this for a very long time. At least that is my current understanding.

The issue though is whether this kind of process has credibility with so much bad research that has been uncritically received, poor definitions in the first place leading to poor research, and in trying to come to grips with something that currently has no definitive biomarkers. Whether they consider the markers we already know about to be sufficient is a critical question, but I doubt they will.

If ME and CFS were diagnostic areas with well defined biomarkers, a generation or more of well funded quality research based on a fairly robust definition, and a wide diversity of quality clinical intervention trials, then the issue would be simple. Sadly that is not what exists.

The IOM has never before. except currently with GWI, been charged with finding diagnostic criteria for diseases.

Here, you can find a list of their reports on 'consensus studies' they have developed. This will give you an idea of what their work entails.
 

Nielk

Senior Member
Messages
6,970
Pursuant to questions in this thread and on my blog about conflict of interest and bias, I got the IOM's policy on conflicts. I've summarized it on the blog, and included some hypothetical examples. I hope it helps explain what these terms mean and how they will be applied.

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.


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.”
 

Ecoclimber

Senior Member
Messages
1,011
FWIW, I did some basic investigation into whether the procedures around this contract violated federal law. They did not, as far as I can tell. They were not required to make it a competitive bid process.

That's not to say my research is definitive. I am not an expert on federal contracting, nor do I know all the places to check for regulations, etc.

The question that I am most interested in is whether the guidelines, procedures or processes on notification to stakeholders, the public with regard to deadlines, comment periods, nominations, appointments etc. ( remember this is public funding) is in violation of HHSAR, OHRP and if so, a complaint can be lodge with the HHS, Office of Inspector General .

What's the point in stating that advocates or organizations will monitor the HHS and IOM process during this period if one has no idea or knowledge if violations are occurring and a process is NOT in place to formally raise an objection or protest a violation to the appropriate authorities for investigation?

As an example, (the whole process surrounding the awarding of the IOM contract and the sudden cancellation and than renewal of the contract notifications etc.), instead of complaining 'in-house' (blogs, forums etc.) are these violations of guidelines or regulations whereby parties can register a formal complaint not via petitions or emails but with HHS OIG?
 
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jspotila

Senior Member
Messages
1,099
The question that I am most interested in is whether the guidelines, procedures or processes on notification to stakeholders, the public with regard to deadlines, comment periods, nominations, appointments etc. ( remember this is public funding) is in violation of HHSAR, OHRP and if so, a complaint can be lodge with the HHS, Office of Inspector General.

The IOM is not part of HHS. It is independent. So there's no way to lodge a complaint with the HHS OIG because that office has no authority over the IOM.

As an example, (the whole process surrounding the awarding of the IOM contract and the sudden cancellation and than renewal of the contract notifications etc.), instead of complaining 'in-house' (blogs, forums etc.) are these violations of guidelines or regulations whereby parties can register a formal complaint not via petitions or emails but with HHS OIG?

I checked to the best of my abilities. I spoke with a contracts officer at the Federal Program Support Center (which was originally handling the contract). I spoke with an attorney. I spoke with two people who have been involved in federal contracting in professional capacities for years. I begged a source to provide me with documentation (and failed). I have not been able to find any violation of the federal contracting regulations.

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, etc etc etc etc etc. I welcome other people putting effort into this. I am tapped out.
 

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
The IOM has never before. except currently with GWI, been charged with finding diagnostic criteria for diseases.

Here, you can find a list of their reports on 'consensus studies' they have developed. This will give you an idea of what their work entails.

I don't think its about experience. What the experience of Gulf War Illness tells us is they got it wrong, not why. I think the underlying process is flawed for this kind of work.

Theyz gotz a hamma. Itz worx forz nailz. So its works for deez twisty nails with little slot on top. The very methodology used is flawed, and integrates a highly biased process that almost guarantees a flawed outcome. If the panel could work to their own methodology, and contained our experts almost exclusively, then we could wind up with an OK result. However that was already done, with the CCC then the ICC. So why do it again?

The only point in doing it again, unless its driven by a large evidence based process (like the CDC is attempting but without the flaws the CDC is building in to the process) then you might get something better, is to drive toward a different conclusion.

I am thinking of coining a new phrase, which is not really new but is new in this context ... hypothesis based medicine. HBM. Much of what we call EBM is based on unproven hypothesis, and the so-called evidence is actually argument and not evidence. In other words, its a house of theories. All of psychogenic medicine fits this definition.
 

justinreilly

Senior Member
Messages
2,498
Location
NYC (& RI)
FWIW, I did some basic investigation into whether the procedures around this contract violated federal law. They did not, as far as I can tell. They were not required to make it a competitive bid process.

That's not to say my research is definitive. I am not an expert on federal contracting, nor do I know all the places to check for regulations, etc.
Thank you, Jennie. As Eco said, this topic really merited at least a look, so thank you for doing that for us.