Live webcast IoM meeting Jan. 27th 1:pm starting

[Ember]

Posted by Wildaisy:

Hello. I’m Joan Grobstein, M.D.

This committee has been asked to develop evidence-based clinical diagnostic criteria for ME/CFS. This could be a very easy task because the Canadian Consensus definition has already been developed by experts in the field, has been recommended by the primary professional society for this disease and was recently endorsed again by experts. Clearly, experts think the evidence supports the Canadian definition. It isn’t perfect, but it doesn’t have to be. Few medical definitions are perfect, since knowledge changes over time. The Canadian is adequate and should be used. Thus your primary task has essentially already been done. If you choose to endorse it, you can spend the million dollars allocated to this report to identify the many gaps in our knowledge of ME/CFS and put together a sorely needed research plan with adequate funding.

Unfortunately, the evidence base for ME/CFS has been adversely affected by two factors: lack of research funding and a multitude of definitions of the disease. ME/CFS receives approximately 6 million dollars per year in most years. Compare this to the billion dollars per year that has allowed AIDS patients to lead essentially normal lives. Because of poor funding, none of the definitions are particularly well-supported by research and many aspects of the disease--multiple infections, immune and mitochondrial dysfunction, and orthostasis--have not been adequately studied. Large, well-powered studies are rare. And, because there are overly broad definitions of “CFS” that include many patients who don’t have ME, there are studies in the literature that do not apply to ME patients at all.

The CDC study will not clarify the definition. The design is flawed--most of the data is self-reported symptoms. The patient community has begged the CDC to collect data on promising objective measures such as 2 day CPET, viral loads and natural killer cell function. The CDC has refused.

Please note that treatment of infections, hypotension, and immune and mitochondrial dysfunction have helped patients in small studies. Looking at evidence of successful treatment, published and unpublished, helps to define the disease’s essential features.

Post-exertional malaise, orthostatic intolerance, cognitive dysfunction, and viral symptoms are the most disabling aspects of ME/CFS. The Canadian includes these and other important aspects; Fukuda and other even broader definitions do not require them. Broad definitions make it impossible to identify abnormalities in bona fide ME patients.

Since the definition issue can be easily solved by endorsing the Canadian, I urge you to address the issue that has made it difficult to characterize the disease and make progress: poor funding. Be bold. Good science costs money. DHHS has asked the wrong questions, but you can still give them the right answers: use the Canadian and increase funding. The medical community has treated this group of patients poorly.

You, as medical leaders, have the opportunity to begin to change that reality.

 

[alex3619]

The claim made at one point that the HHS will have no contact with the panel aside from administrative things, and hence by implication there will be (edit) no undue influence, is directly contradicted by earlier testimony.

The problems are largely methodological and procedural, which we have already seen with the haste, secrecy and complete disregard for stakeholders. The P2P panel will put together an evidence base review which will be provided, either in outline (due to time constraints) or in full, to the panel. This review will contain inherent structural bias in keeping with how these things are done. That review should be publicly available at some point, and we really must see it, and scrutinize both the review and the methodology for the review.

If you want to railroad a panel you don't do blatant panel stacking. You limit the terms of reference then control the allowed information. It doesn't even matter if this is intentional or just a side-effect of the process, the outcome is the same.

PS Edited to add the word "no" which should have been there but my brain glitched.

 

[Nielk]

Moreover, Klimas and maybe another panelist are serving on both the IoM and the P2P committees. How is that going to work?

 

[shannah]

On a positive note, I was (unexpectedly) impressed by Nancy Lee's presentation. She gave the impression that she really did understand our perspective. And she said some really helpful things. And I thought she directed the committee in a good direction.

Did any one else get that impression, or have I allowed myself to get carried away because it was a much better presentation than i had been expecting?

... or are they just getting more selective and polished in their language? There seems to be an awful lot of 'doublespeak' sometimes. Often I'm left feeling that what they say (carefully crafted) and what they do are two different things.

 

[justinreilly]

I'm going to play a game of telephone. Except the message won't have to go around a whole circle to get ridiculously distorted. I just needs to go in my ear and out my typing fingers due to my brain fog making a mess of my thoughts.

So, here is my cartoonish memory of Jeannette's beyond fabulous speech yesterday. I will then compare it to the real thing when it comes out, or the transcription on mecfsforums.com if it is posted there.
_____________

Jeannette:
"Quo Warranto? (i.e. 'By what legitimate authority do you exist?'). You are an illegitimate and unlawful medical entity akin to a back-alley abortion clinic. I have personally filed a federal lawsuit to uncover your secret ploys. My husband is hungry for litigation, but I have asked him to wait to see if you will slink away and disband after this meeting.

You are not qualified. Half of you are ME rubes who just fell off the turnip truck. You can not produce any meaningful definition. That prospect is insanity (as Mindy said).

Fukuda destroyed Millions of lives, but you will not be permitted to commit a similar offense.

If you draft a definition, it will be immediately housed in a reliquary and shipped to the the Ripley's Believe It or Not Museum warehouse like at the end of Raiders of the Lost Ark.

I will then retrieve it from the warehouse and grind it into fairy dust with lawsuits and public outcry. Your fairy dust will be scattered to the four winds, to live in memory only.

Thank you for your kind attention."

 

[alex3619]

Maybe we should start a website called "The Government's View, Not." and post everything they do in a satirical manner.

 

[akrasia]

I'm going to play a game of telephone. Except the message won't have to go around a whole circle to get ridiculously distorted. I just needs to go in my ear and out my typing fingers due to my brain fog making a mess of my thoughts.

So, here is my cartoonish memory of Jeannette's beyond fabulous speech yesterday. I will then compare it to the real thing when it comes out, or the transcription on mecfsforums.com if it is posted there.
_____________

Jeannette:
"Quo Warranto? (i.e. 'By what legitimate authority do you exist?'). You are an illegitimate and unlawful medical entity akin to a back-alley abortion clinic. I have personally filed a federal lawsuit to uncover your secret ploys. My husband is hungry for litigation, but I have asked him to wait to see if you will slink away and disband after this meeting.

You are not qualified. Half of you are ME rubes who just fell off the turnip truck. You can not produce any meaningful definition. That prospect is insanity (as Mindy said).

Fukuda destroyed Millions of lives, but you will not be permitted to commit a similar offense.

If you draft a definition, it will be immediately housed in a reliquary and shipped to the the Ripley's Believe It or Not Museum warehouse like at the end of Raiders of the Lost Ark.

I will then retrieve it from the warehouse and grind it into fairy dust with lawsuits and public outcry. Your fairy dust will be scattered to the four winds, to live in memory only.

Thank you for your kind attention."

Danny ze Dog posted this on FB this morning:

"Resistance is carried out not for its success, but because by resisting in every way possible we affirm life."
- Chris Hedges

 

[justinreilly]

Unfortunately the IOM panel has limited options, being bound by contract. Some of the ideas presented are good, but they can't happen. What can happen though, if the panel experts get railroaded by the process, is they can resign or refuse to endorse the final report, at least I think they can .. having the contract out of the public view makes it difficult to determine what the situation really is.

If the contract is cancelled though the money will not go to CFS or ME research, it will be absorbed back into HHS funds I think.

The panelists aren't bound by anything legally. They will receive no compensation (i.e. 'consideration') and without any consideration, no contract exists. They are volunteers, so legally at least, they can basically do what they want.

They may be reluctant to rock the boat and not follow orders, since they are scientists, a group it seems to me that likes to follow rules. Also they may not want to offend the IoM which is prestigious. They may feel they have an obligation to do more than just endorse CCC since that might not be much work.

But it is possible for them to endorse the CCC practically, legally and probably even under the terms of the statement of work (a problem is we don't know what the task order says). Does CCC provide subgroups?

I didn't hear all of Nancy Lee's talk, but I think she was giving them a wide berth to do what they saw fit. Is that right?

Anyone who doesn't agree with the consensus can write a dissent which will be included in the report.

I really don't think that anyone of our experts or anyone who sides with us should resign. They will just fill the slot with a lackey. Somewhere it says a consensus should be achieved. If we can't get CCC thru, then at least we can disrupt the consensus which will incredibly undermine the resultant definition, especially in comparison to CCC and ICC which were consensuses. The best thing would be if all our experts stick together no matter what and agree to the same consensus or dissent. That would have a lot of power.

No, the money won't go back to ME research. But the important thing is the definition (and if the government saves some money, so much the better, even if it doesn't go into ME research).

Am I the only one who chuckled several times when we were repeatedly assured the IOM report will be very rigorously be reviewed? Oh, like the shoddy GWI report they released recently?

I think just about everyone was about to burst out laughing.

 

[Chris]

I too was very, very disturbed by Susan Maier--who seemed proud of the fact that she had known nothing about ME before--just the person for the job, obviously. I was also left more confused than ever about the process of this crazy P2P thing--especially when she explained that the relationship between the experts who would testify and the panel of explicitly non-expert people ("opinion leaders" in various fields--just what we need, industrialists, financiers, lawyers)- her analogy was experts giving testimony before jurors at a trial. Has she forgotten that a jury that could not understand DNA evidence acquitted OJ Simpson a good many years ago? One needs to know something in order to understand difficult material--is our fate going to depend on how persuasive a researcher can be in front of an ignorant panel? Is this "democracy" at work--in a new guise? I was just appalled.

I think the IOM just might--slim chance, but just might--produce something useful; I see nothing but negative consequences from that insane P2P thing--and I have not even got started on the inappropriateness of EBM to this purpose--EBM, for all its weaknesses and faults, can help avoid some disasters produced by ill-tested interventions. But as a way of evaluating research it strikes me as being way out of its depth--again, the only people who can properly evaluate research are other researchers in the field. Heaven help us!
Chris

 

[justinreilly]

Yes, having all non-ME-experts, much less non-scientists and non-medically-trained people is totally insane.

The jury analogy fails in my mind. You are right about the OJ trial. Jurys in criminal trials with technical evidence have long been controversial. And you don't even have a right to a jury in civil cases. Judges will deny requests for juries if the evidence won't be understood by the jury (because it is technical, etc). There are even specialized courts like water rights courts and tax courts bc it's realized that even judges need specialized training to hear some kinds of technical cases.

Also, Maier conveniently didn't answer Lily Chu's question/point that the P2P process is only for non-controversial topics. I think that point is our best argument (though we have other very strong ones too), it's so cut and dried.

 

[akrasia]

Justin wrote:

Also, Maier conveniently didn't answer Lily Chu's question/point that the P2P process is only for non-controversial topics. I think that point is our best argument (though we have other very strong ones too), it's so cut and dried.

This goes to the very heart of the problem of the relationship of mainstream advocacy to the DHHS. Groups like the CAA were enlisted in the fiction that m.e. bore no stigma in research circles and real world practice. It rendered this community unable to see just how marginalized it was by maintaining the illusion of normality and business as usual. Acknowledging the "controversy" surrounding the disease would raise the question of responsibility. The bid for the appearance of seamlessness would be lost.

Can an entity like the IOM, a servant of the DHHS, no matter what their claims of autonomy, even acknowledge the truth that there is a controversy that has led to an ongoing violation of human rights without implicating US government policy framed by Hillary Johnson, the other day, as diabolical.

The IOM process, ironically, has allowed this voice of indictment by the more militant members of the patient community to be articulated.

I am eager to read Eileen Holderman's contribution.

 

[shannah]

That last slide of Unger's from CDC's presentation comparing certain symptom severity in ME as compared to some other illnesses, did anyone catch if it was explained what criteria was used in selecting which illnesses to use to compare? I'll try posting a copy here.

 

[Nielk]

Is it a fact then that this panel has been formally approved as it stands?

It's interesting to me that they invited our comments as to the make-up of the panel, yet nothing was mentioned about it at the meeting.

 

[leela]

I am still totally confused by what relevance the P2P thing has to this panel, and who is choosing what data the panel will be reviewing?

 

[Ember]

Posted by Wildaisy: "This is what Jeannette Burmeister said:"

IOM Meeting January 27, 2014
In-Person Comments by Jeannette Burmeister

Hello. I’m Jeannette Burmeister and I’m an attorney.

I’ve heard some people at HHS are confused about patients’ deeply-felt opposition to your project. Let me explain in simple terms why:

· HHS hijacked the federal CFSAC recommendation and ignored an unprecedented and impassioned request by 50 international M.E. experts to cease and desist.

· The majority on your committee are non-experts. Insanity!

· HHS insured bio-medical research will be not be funded or replicated and yet ordered an evidence-based review. You are hurtling down the psychological rabbit hole, repeating the Gulf War Illness anti-science debacle.

· HHS hired an institution without experience or authority to develop case definitions.

· An excellent case definition, based on science, already exists and the experts endorsed it.

· The IOM has a fatal organizational conflict of interest. I have filed a complaint with the Office of the Inspector General. A formal investigation is under way.

· HHS has broken federal law as to FOIA compliance. 2.5 weeks ago, I filed a lawsuit against HHS and NIH in U.S. district court.

· To circumvent competition rules, HHS moved from seeking a standalone contract to issuing a task order without a clear scope, violating umbrella contract terms.

· HHS issued misleading statements about the nature and terms of, and parties to, the contract.

· And finally, hundreds of thousands of patients’ lives were ruined or ended by a federal consensus definition in 1994. We have long memories. Patients are furious and alienated by what can only be called state-sponsored bullying.

Given your time frame and the meager “budget-dust” sum provided to you, not even a thorough literature review is possible. Do you really expect anyone to consider the definition you produce to be science-based? Everything about this is lose-lose.

You may attempt to serve as oracle of the biased and obstructive NIH/CDC, but your conclusions will be rendered meaningless soon enough. Academic scientists are closing in on the cause of this disease. In due time, your consensus “fairy dust” will be headed for Ripley’s “Believe It Or Not”—next to the entries about the earth being flat and the sun revolving around the earth.

My husband, who is an attorney with the world’s largest law firm, and I will not hesitate to bring additional lawsuits. We are supported by thousands of patients who are ready to fight you at every step, in federal court and in the court of public opinion.

Wildaisy also posted: "This is the one Jeannette had prepared to present at the meeting, but she rewrote. I still think it is great, so she is allowing me to post it here."

IOM Meeting January 27, 2014
In-Person Comments by Jeannette Burmeister

My name is Jeannette Burmeister. I am a patient and I am here to oppose this IOM study in the strongest possible way.

Please know that nothing I have to say is in any way personal to any of you.

For patients, this is the fight of our lives and if this sounds overly dramatic to you, then this may indicate that you are not fully aware of the irreparable harm you are about to do. I respectfully suggest that you research the disgraceful IOM history with Gulf War Illness. Because if there is one thing I am sure of, it is the fact that this committee will psychiatrize this disease by endorsing antidepressants, psychotherapy and exercise, as the IOM did for Gulf War Illness. Your report is a foregone conclusion given the IOM’s issued opinions about our disease in the past, which create an organizational conflict of interest that is currently the subject of a formal investigation by the Office of the Inspector General.

I am sure you eight non-expert panel members are all accomplished in your area of expertise. I am not questioning that, but I am reminding you that you are not experts in THIS disease. The Gulf War Illness committee members probably had similarly impressive credentials and good intentions, but we’ve seen the disastrous results of their efforts. The foremost experts for this disease have stated that this effort will harm patients. And yet, here you are, not having treated a single patient with this disease or researched the disease in any meaningful way or in any way at all. This is not a purely intellectual exercise. It has taken the experts decades to accumulate their expertise by treating and researching this disease and you are not going to become experts capable of producing an accurate definition by reading about this extremely complex and very unique disease for a bit more than a year in your spare time. What you have been asked to do is simply not feasible to do competently no matter how much you might want to believe it is or how good your intentions are.

I’d like to suggest to ALL committee members that you are being played. This study is a set-up because it is designed as an “evidence-based” review. HHS knows full well that replication studies of bio-medical research of this physical disease are basically non-existent in the absence of government funds for them, whereas research (quote, unquote) of the alleged psychological aspects or of coping mechanisms abounds thanks to HHS funding. For example, ask yourselves why Dr. Unger of the CDC is kicking and screaming resisting a 2-day exercise test, despite overwhelmingly strong research by Staci Stevens and Dr. Chris Snell establishing the test as a very reliable biomarker. I bet some of you have never even heard of Stevens and Snell. That right there should give you pause.

I am asking you to go home tonight and really think about whether you could live with yourselves if you did to us what the IOM has done to Gulf War veterans. Because if you go forward, you will be accomplices in a process designed to do just that and it WILL stay on your conscience for the rest of your lives. Patients are watching and we WILL hold you accountable if you proceed down this path. Do the right thing and refuse to be part of this diabolic plan to, once and for all, bury this disease and its patients.

 

[Bob]

That last slide of Unger's from CDC's presentation comparing certain symptom severity in ME as compared to some other illnesses, did anyone catch if it was explained what criteria was used in selecting which illnesses to use to compare? I'll try posting a copy here.

That graph is an excellent demonstration of why the existence of 'fatigue', 'sleep disturbance' and 'pain' cannot be used to make a reliable diagnosis of ME. (I hope the IOM committee noticed it.)

(@shannah, I didn't see Unger's presentation.)

 

[alex3619]

The experts who present on the P2P eventually may or may not be biased. The evidence base provided may well be biased, something I am writing a blog about which might form a submission to the panel. The process itself is a bureaucratization of science and medicine. Its a translation of the science and medicine into bureaucratic policy. It is NOT science, nor is is medicine.

 

[Nielk]

That last slide of Unger's from CDC's presentation comparing certain symptom severity in ME as compared to some other illnesses, did anyone catch if it was explained what criteria was used in selecting which illnesses to use to compare? I'll try posting a copy here.

What is 'pain behavior'?

 

[shannah]

What is 'pain behavior'?

Good question!

 

[Ember]

Tuesday,January 28, 2014
By Mindy Kitei

"Below is my testimony from yesterday's conference at the Institute of Medicine:"

My name is Mindy Kitei, and I’m a journalist. I’ve been reporting on myalgic encephalomyelitis for more than twenty years and started my blog, CFS Central, in honor of my friend Nancy Kaiser, who died of the disease in 2008.

Fifty of the finest ME experts believe that the IOM lacks ME expertise and that the government should adopt the Canadian Consensus Criteria definition immediately.

Patients believe that the IOM will devise a name worse than chronic fatigue syndrome, something like “chronic multi-symptom illness,” the meaningless moniker the government and IOM use for Gulf War Syndrome. On the IOM website, a curious diagram that accompanies an article by Dr. Daniel Clauw, lists several diseases: Gulf War Syndrome, fibromyalgia and CFS, among them, all covered under the big umbrella of somatoform disorders, psychiatric ailments that just LOOK like physical diseases.

Tell that to Nancy Kaiser, who experienced multiple seizures a day....

Patients believe that the IOM committee will lump real ME patients with the flawed cohort that CDC studies....

The best predictor of future behavior is past behavior. In the IOM’s book Gulf War and Health, the IOM Gulf War committee writes about CFS—since the symptoms resemble Gulf War—and recommends graded exercise for CFS, which can lead to crashes that last months, even years. Graded exercise is also recommended by CDC and psychiatrists like Simon Wessely—both of whose work the IOM Gulf War committee endorsed.

Given its clear bias, the IOM must recuse itself. And the government should adopt the Canadian Consensus Criteria and spend that $1 million for real research. Thank you.

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