CFSAC 1/2 day meeting today - Dec. 11

[Andrew]

Can you post your testimony here?

Here my testimony including bibliography.

Thank you to the CFSAC for letting me speak. My name is Andrew Bokelman.

Most of the American ME/CFS experts sent a joint letter to the HHS, urging them to adopt the Canadian Consensus Criteria. Despite this, the HHS continues down the path to a project that circumvents the experts. The contractor for this project is Institute of Medicine (IOM), who recently admitted they have no experience with criteria development. But the IOM did develop a treatment guide for Gulf War Syndrome, which includes a section on Chronic Fatigue Syndrome. I read this section to see the quality of their work. I was not impressed.

For example, they recommend graded exercise, and to support this, they reference three web pages that cite no research. The IOM also references two journal articles, but neither one says that exercise helps people with CFS, and one doesn’t even mention CFS.

I also looked at their coverage of pharmaceuticals, which only mentions pain control and sleep. In contrast, the Canadian Consensus document covers pharmaceuticals for many symptoms. I also have two books that do the same, and they include hundreds of citations. It's remarkable that the panel overlooked so much information.

The IOM points out that there will be a different panel this time. But this solves very little, because the project will use the same system for quality control.

But the problem is not only with the IOM. It is also with the idea that one can take evidence based mostly on weak criteria, and use this to create strong criteria. This can’t be done. And in the absence of reliable biomarkers, the only way to improve criteria is via ME/CFS experts drawing from a combination of research and observation. This is what the Canadian Consensus authors do.

But it's clear that the HHS doesn't want to simply accept the Canadian Consensus. So I suggest the HHS sit down with the experts and work out a mutually agreeable way to perform validation field-testing for the Canadian Consensus. See if the criteria work. Then proceed from there. This is a much better solution than paying one million dollars to a contractor that has shown gross incompetence with CFS research, and who has no experience with criteria development.

Thank you for letting me speak.

-----------------------
Bibliography

Canadian Consensus Document
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Clinical Working Case Definition, Diagnostic and Treatment Protocols. Carruthers et al., Journal of Chronic Fatigue Syndrome, Volume 11, Number 1, 2003.

IOM Gulf War Syndrome Treatment Guide
Gulf War and Health: Treatment for Chronic Multisymptom Illness. Washington, DC: Institute of Medicine of The National Academies, 2013.

Two books I have that cover pharmaceuticals and include citations
Reviving the Broken Marionette: Treatments for CFS/ME and Fibromyalgia. Haavisto, 2008
Chronic Fatigue Syndrome: A Treatment Guide, 2nd Edition. Verrillo, 2012.

 

[Firestormm]

Just came up on an alert:

CFIDS AA New CEO testimony: http://solvecfs.org/cfids-association-update-cfs-advisory-committee/

I dunno if you have already featured it on this thread.

 

[Andrew]

I need to explain something in my testimony I criticized the use of the two studies with very simple statements, but now I want to explain more. The selling point of these IOM studies is that they are evidence based. In the first study, it dealt with the hypothalamic-pituitary-adrenal stress axis in CFS. It never says exercise helps CFS, But someone reading it could speculate that some of the responses reduce the experience of fatigue or increase well being or perhaps something else. In the second one they say that exercise leads to the body releasing chemicals that reduce the experience of fatigue. But this was not research done on CFS, so they are assuming that if we exercise it will release this chemical and it will be beneficial to our condition.

And here's why these are not evidence based conclusions, not to mention being reckless and irresponsible reporting:

You cannot take a test that seems to show something positive in a healthy person, and assume it is going to affect a sick person the same way. For example, people with severe asthma can experience fatigue. But it is reckless to encourage doctors to tell patients to exercise the fatigue away. And the reason is because exercise can exacerbate asthma symptoms (this varies from patient to patient). This is similar to what we have with ME/CFS, where exercise can exacerbate our symptoms. And so it doesn't matter if we feel exhilarated by exercise in the moment if for the next two weeks we can hardly walk around the house.

Most people intuitively understand this with other illnesses. But because people deep down inside don't really believe we are sick, they feel free to recommend things without regard for the consequences.

 

[alex3619]

http://www.occupycfs.com/2013/12/12/lack-of-progress-report/

"I’ve seen so much vitriol and personal attacks in email and blogs around the IOM study. I don’t see how this will be constructive going forward, given the opportunity before the ME patients and families.

Everyone I know working to make the clinical diagnostic criteria a reality has good intentions and wants to make things better for ME/CFS patients. Implying that IOM staff or committee members don’t have good intentions will not be helpful, and it could backfire.I had patient advocates apologize to me in private – when this happens in a public meeting or blog or email – (lost audio)"

"Don’t make vitriolic statements that assume IOM panelists have bad intentions in a public forum. Those who do will be called out."

As an admonishment that criticism should not be personal, this will be given some credibility. Personal criticism without hard evidence is usually viewed as a bad thing.

However ... there are a lot of howevers.

These are people being put forward for a panel on which public comment IS INVITED.

The processes used to get here from the HHS/IOM could not have been much more antagonistic to the patient community if they tried. Rushing, lack of transparency, lack of real accountability, action in secret, prior evidence with the GWS reports that "evidence based" reviews can lead to conclusions like CFS should be treated with CBT/GET and so on. Its a long list.

Dr Lee may also be perceived as antagonizing the community, whether or not it was her intention. This leads to two points. First, she is NOT a patient advocate, she is an HHS advocate in this respect.

Second, its not about what THEY INTENDED. Its about how WE ARE AFFECTED. This applies to Dr Lee's comments, the whole HHS/IOM fiasco, and the likely outcome of the IOM fiasco if it goes to completion.

THEY WILL BE JUDGED ON THE OUTCOME. It doesn't matter what their intentions were. If the outcome is bad then they failed. They also cannot use the defense that it was unforeseeable because we have foreseen it and been very vocal about it.

 

[Andrew]

Dr. Lee points to everyone's good intentions, but that is not the guiding principal, IMO. Good intentions don't automatically lead to good decisions, and that's what most of us are complaining about. We are complaining about the decision to go with IOM.

 

[WillowJ]

I haven't seen any attacks on people's motivations, just their qualifications for the task at hand and whether they seem to understand this particular disease.

If they're unqualified and don't understand it likely means they don't have relevant life experiences, that's all.

 

[Izola]

I've missed a lot of it, but right now, Dr. Lee is defending/explaining the IOM contract -- Eileen Holderman and Dr. Mary Ann Fletcher are stating their disapproval of the IOM contract. Dr. Lee said the contract cannot be cancelled, that it's a "done deal".

Done like in totally fried?

 

[Izola]

Lee - wants to remind CFSAC is only an advisory committee...i.e. no power.

An IOM coup??????

 

[Izola]

Am I the only one who feel that Lee just threatened us to keep quiet as far as criticizing this process?

No.

 

[Ember]

Today’s Tweets: #NotAPersonalAttack
Posted on December 12, 2013 by Jeannette Burmeister

@Sebelius Irony: Disrespect by #HHS unifies #MECFS community more than ever. Many call for Dr. Lee’s resignation. #NotAPersonalAttack

@HHS_DrKoh Irony: Disrespect by #HHS unifies #MECFS community more than ever. Many call for Dr. Lee’s resignation. #NotAPersonalAttack

I am very sick after yesterday’s CFSAC “webinar” from hell. I had to cancel my flight to go home to see my 3-year old girl and my husband, Ed.

I will write about yesterday’s CFSAC “meeting” once I recovered from its torture. In the meantime, how about tweeting the above. I have never seen the patient community that united. Ever. Thank you, Dr. Lee.

 

[Ecoclimber]

I took it as a threat. The fact that HHS will not reveal the IOM contract under FOIA is big. Under an administration of open transparency, what are they hiding? Why won't they disclose the contents of the written contract if its nothing more then what they have disclosed so far? Why the secrecy?

In the U.S. such an action by an official of the U.S. government should be viewed on a very serious level. It means nothing concerning Dr.Lee's intent. It is how many patient advocates and patients within the ME/CFS community understood the comment. She is a professional representing her agency, her conduct should be professional. A public servant cannot behave in this manner. An analogy could be made of a senator berating his constituents because they are complaining for his failure to represent their interests in Congress...a no brainer. I and others took it as a threat. That is all is needed. Not only Dr. Lee should be removed from her position but an apology by HHS to the ME/CFS patient community is required. Many patients became upset and physically sick over this meeting.

Remember HHS is part of a consortium of Federal Agencies which includes the Department of Homeland Security. If you view the history of the Occupy WS movement and given the recent revelation concerning our intelligence community, patient advocates who are legitmately exercising their free speech rights and practicing due diligence with regards to the IoM contract do not know if their actions have or will place them on DHS watchlist list after Dr. Lee's chilling comments. As U.S. citizens and taxpayers, we have the right to hold the U.S. administration accountible for their actions. The last time I check, this govenment is a democracy with quaranteed civil liberities but that is a whole another issue.

I have no idea what's in those emails referred to in her comments but I don't want to be lumped together with them nor lumped together as a suspect group.

I will not let this type of behavior go unnoticed.

Eco

 

[heapsreal]

The bottom line is they don't believe we are sick???

If they were truly interested in cfs/me they would have read through a lot of the research psychobabble and all. They would then understand by the research that we have a lot of abnormalities and dysfunctions going on with the immune system and the nervous system which is proof we are sick with infections, hpa axis dysfunction etc etc

If us as patients can find this information to try and understand what's happening to us, why can't they. I say they just haven't done any home work and are just going off the rumors they have heard over the years about yuppy flu and the rest of that crap. It reminds me of the kid who rocks up to school the day he has a book review and just reads the blurb at the back of the book and tries to fool everyone. But those that have read the book know that the student hasn't read the book and is full of crap.

By the way, I think one of the biggest issues that has set cfs/me back is the wombat who came up with the yuppy flu saying and this has greatly helped keep a black cloud over us to this day.

 

[alex3619]

I regard McEvedy and Beard are the biggest wombats of all, and thats an insult to wombats, which are placid inoffensive herbivores (though don't get one riled). They claimed ME is mass hysteria after a superficial investigation of the Royal Free Hospital ME outbreak in 1955, and published this in 1970. That set the stage for psychobabble, and even the creation of the label CFS itself. Their paper was very influential, and arrived at about the time psychosomatic medicine was given a huge boost by the new move to what is now called biopsychosocial medicine.

 

[leela]

"Mass Hysteria" is mass hysteria.

 

[SOC]

I regard McEvedy and Beard are the biggest wombats of all, and thats an insult to wombats, which are placid inoffensive herbivores (though don't get one riled). They claimed ME is mass hysteria after a superficial investigation of the Royal Free Hospital ME outbreak in 1955, and published this in 1970. That set the stage for psychobabble, and even the creation of the label CFS itself. Their paper was very influential, and arrived at about the time psychosomatic medicine was given a huge boost by the new move to what is now called biopsychosocial medicine.

Are they dead now, or can I send them a sharply worded email?

 

[alex3619]

Are they dead now, or can I send them a sharply worded email?

McEvedy used us for his PhD thesis. Beard was his supervisor. I think it likely McEvedy is stilll around, I am not so sure about Beard. Read here, and particularly the comment by Byron Hyde on what McEvedy said: http://www.mecfsforums.com/wiki/Royal_Free_Epidemic_of_1955

"Why had he written up the Free Hospital epidemics as hysteria without any careful exploration of the basis of his thesis? I asked. His reply was devastating. He said, "It was an easy PhD, why not.""

 

[heapsreal]

McEvedy used us for his PhD thesis. Beard was his supervisor. I think it likely McEvedy is stilll around, I am not so sure about Beard. Read here, and particularly the comment by Byron Hyde on what McEvedy said: http://www.mecfsforums.com/wiki/Royal_Free_Epidemic_of_1955

Thats foobicated(Its an F word I can use).

 

[Izola]

I regard McEvedy and Beard are the biggest wombats of all, and thats an insult to wombats, which are placid inoffensive herbivores (though don't get one riled). They claimed ME is mass hysteria after a superficial investigation of the Royal Free Hospital ME outbreak in 1955, and published this in 1970. That set the stage for psychobabble, and even the creation of the label CFS itself. Their paper was very influential, and arrived at about the time psychosomatic medicine was given a huge boost by the new move to what is now called biopsychosocial medicine.

Yeah, I read about this in a college Soc. textbook in the "70's. No supporting references or anything. I right off thought, that's dumb. You can't catch ideas out of the air. Idea Miasmas. How quaint. Iz

 

[readyforlife]

I look forward to these meetings twice a year. It gives me hope and keeps me going to not give up. I love to listen to our advocates and those suffering with ME, fighting for our rights. This webinar I could not follow and don't know what happened at all. I tried to keep up by reading what people were saying but it was all a mess.

So was there any good news or anything of interest that was said? Anything that looks good for us to look forward to in the upcoming year? Any research hope for us in the upcoming year?

Readyforlife

 

[August59]

Dr. Lee said the CCC has been around for 10 years, without a lot of traction outside of the CFS community. They want to broaden the outreach to providers outside the country and that there is no better (?) way to do that than the IOM. They are specifically going to look at results from CDC study.

They should be looking at the results of CFI/Lipkin study, Montoya's study an I was under the impression that Dr Dan Peterson was working on something.

The CDC doesn't know how to conduct a study and would be the worst possible contributor for IOM information. I hope the IOM is told this at some point. That they can not develop an accurate or useful definition using anything that the CDC has compiled as accurate information.

If they are going to use the CDC's information, then having our own experts isn't going to be of any value. They are just going to listen to them and blow them off.