The P2P Draft report is out

[Denise]

How bizarre. The main reason for a committee to have contact with presenters would be, to my mind, to be able to work out if they were talking through their hats (to be polite). Why have minders? Maybe things work differently across the Atlantic.

The report seems to be an account of the interests of about 6-8 people. The code words are easy enough to read. It is intriguing how this came about. Maybe what matters is not the committee that wrote the report so much as the committee that appointed the committee that wrote the report or even the committee that appointed the committee that appointed the committee that wrote the report - except that that is probably the same people who wrote the report in some cases. Not to mention the committee that invited the experts...

Interesting anyway.

Perhaps part of the reason for the minders is that at least at the outset of the process, the panel is supposed to be unbiased about (in this case) the illness.

It has been suggested (by people involved) that some (I do not know how many) of the recommendations made by the working group that NIH assembled to develop the agenda, nominate speakers etc., were not implemented.

 

[Marco]

.

Maybe what matters is not the committee that wrote the report so much as the committee that appointed the committee that wrote the report or even the committee that appointed the committee that appointed the committee that wrote the report - except that that is probably the same people who wrote the report in some cases. Not to mention the committee that invited the experts...

Interesting anyway.

Pretty much spot on. Having previously been involved in providing research (not medical) to bureaucrats the findings are pretty much determined by the defined terms of reference, neutered during the drafting process and if all else fails senior bureaucrats just ignore the bits they don't like and carry on as before.

That said its not the worst report from all accounts.

 

[jimells]

I think the criteria is needed for those who dont know much about cfs/me.

Except if they don't know much about the illness, they have no business diagnosing or treating it. This is an illness for specialists. I don't want my local nurse practitioner inserting cardiac stents. Or treating ME.

Unfortunately the P2P report doesn't say this. Although conveniently vague, it suggests to me that if the local clinic hires a social worker and a therapist, they can diagnose and treat us. It mentions those specialties and even homeopathy. It says nothing at all about actual medical specialists. I don't recall any statements bemoaning our lack of access to specialist care. One can certainly make a case that they use the word "physician" to include any/all medical specialties, but given the history or inadequate care, they need to be more specific.

 

[Jonathan Edwards]

In response to Large Donner and Nielk,
I am sorry to seem inflammatory. I think the answers to most of your questions are in my previous posts and I do not want to go over stuff unnecessarily so I will focus on one thing.

The key issue seems to be 'hypothetical disease'. I stick to that. There is a hypothesis that there is one disease called ME - which some people feel is well validated and others not. The same applies to rheumatoid arthritis and multiple sclerosis - even now and it will change with time. But it does not apply to hypertension and diabetes because these are just measurements, which have often been made, and they are not considered 'diseases'.

This is not an easy issue. For years in the first seminar I gave to my clinical students I asked them what they meant by 'a disease'. By the end of the seminar they always agreed that they did not know. I would be interested to know what you (Large Donner and Nielk) mean by 'a disease'. Then we might see that we are on the same side. One of the problems for me is that this P2P report is written by people who think there is 'a disease' but I suspect that they have not thought what they mean by that. My feeling is that to solve the problems that PWME have we need to get a bit deeper. Having a disease name for financial purposes is something quite separate. Put another way, my impression is that what is needed most of all in this discussion is everyone being up front about what they are really trying to say because in the end, it will be plain as daylight anyway. I am well aware that some of my colleagues who recommend certain treatments are most at fault here. I think P2P need to decide what it is they are trying to say.

But I do emphasise that I think the weakness in the ME hypothesis is not that it is wrong but that it is too simple - there will be several of these diseases - all of which may lead to a single problem that we could measure like hypertension or diabetes - maybe an overproduction of a specific signalling molecule - but I doubt that would be a disease. Nor would it be a syndrome like 'CFS' but so far we don't know what it is. It may be that all this analysis is best kept to quiet conversations between researchers, as I was suggesting, and would not go down well in reports. I admit that. But if the reports are not even making any impact, or even going in the wrong direction, maybe it is worth at least discussing things on PR?

 

[Ember]

We all know and the experts in the field know, why are they trying to reinvent the wheel again.

Does the Draft Report set the stage, I wonder, for another IOM contract or perhaps for using the IOM clinical definition as a research definition? Does DHHS plan to disseminate its results worldwide, and will ME be lost in the process?

The Panel's statements, “ME/CFS exists...” and “We believe ME/CFS is a distinct disease...,” may not be technically false, but they're certainly misleading. ME/CFS exists as a hybrid construct, but does it exist as a distinct disease? Do the lead authors of the ME/CFS criteria (CCC), for example, consider ME/CFS to be a distinct disease? Along with the other members of the International Consensus Panel, they recommend that patients diagnosed with ME/CFS should be reassessed using the ICC: “Those who fulfill the criteria have ME; those who do not would remain in the more encompassing CFS classification.”

The Panel's stated beliefs lead to their recommendation that “the ME/CFS community [should] agree on a single case definition (even if it is not perfect).” Does that recommendation preclude the separating of ME from CFS? Notice the silence on expert stakeholders:

“Assemble a team of stakeholders (e.g., patients, clinicians, researchers, federal agencies) to reach a consensus on the definition and parameters of ME/CFS;” and

“A national and international research network should be developed to clarify the case definition and advance the field.”

Will ME be buried again?

 

[Jonathan Edwards]

Government officials are governed by politics. The art of political leadership, I have heard, is to see where the crowd is going and to jump out in front of it. The crowd in our field has in recent years been getting its act together with more and better research, at the scientific end, and a lot more cohesion and focus from the patient end, thanks to forums like this one. The government folks have noted that the tide has turned and now it looks to be politically safe and appropriate for them to start to play the role they should have been all along--furthering scientific research. The $1 million dollar pricetag for P2P might be viewed not only as a huge waste of money, but as a political indicator of a willingness to change direction, to go where the crowd is now going, to give the appearance that they are functioning as leaders. Let's help them know exactly which way THIS crowd is going by responding to the draft report.

Machiavelli might second that.

 

[jimells]

How bizarre. Why have minders?

The report seems to be an account of the interests of about 6-8 people.

Exactly. The entire process has been carefully orchestrated, as laid out by the emails obtained via FOIA requests. The minders were there to make sure the "jury" was not "contaminated" by contact with critics of Our Dear Leaders, just like in any other authoritarian state.

But I suspect the minders are losing control. This is the time to make a lot of noise.

 

[jimells]

Perhaps part of the reason for the minders is that at least at the outset of the process, the panel is supposed to be unbiased about (in this case) the illness.

The idea that a panel of uninformed people can somehow produce an informed report is...(pick your favorite expletive)

 

[jimells]

For years in the first seminar I gave to my clinical students

I wish I could've been one of your students. I'll bet not many of them fell asleep in your class!

 

[Ember]

Put another way, my impression is that what is needed most of all in this discussion is everyone being up front about what they are really trying to say because in the end, it will be plain as daylight anyway.

The ICC purports to define a disease:

The purpose of diagnosis is to provide clarity. The criterial symptoms, such as the distinctive abnormal responses to exertion can differentiate ME patients from those who are depressed or have other fatiguing conditions. Not only is it common sense to extricate ME patients from the assortment of conditions assembled under the CFS umbrella, it is compliant with the WHO classification rule that a disease cannot be classified under more than one rubric....

When research is applied to patients satisfying the ICC, previous findings based on broader criteria will be confirmed or refuted. Validation of ME being a differential diagnosis, as is multiple sclerosis (MS), or a subgroup of chronic fatigue syndrome, will then be verified.

The two-day exercise test has been providing validation for PENE, the cardinal feature of ME.

 

[A.B.]

The two-day exercise test has been providing validation for PENE, the cardinal feature of ME.

It is a candidate but there hasn't been enough research to say that it can distinguish ME from other diseases.

 

[jimells]

It is a candidate but there hasn't been enough research to say that it can distinguish ME from other diseases.

Has there been this type of research on the other criteria such as Oxford, Fukuda, Reeves, etc?

 

[Nielk]

The idea that a panel of uninformed people can somehow produce an informed report is...(pick your favorite expletive)

And produce it within 24 hours!

 

[Ember]

It is a candidate but there hasn't been enough research to say that it can distinguish ME from other diseases.

Any ideas why no such research was proposed?

 

[Denise]

"A.B. said: ↑
It is a candidate but there hasn't been enough research to say that it can distinguish ME from other diseases."

I had thought that Chris Snell et al. have indicated that the lack of recovery (and in many cases worse performance) on day two of a CPET distinguished ME from other illnesses.

 

[alex3619]

@Jonathan Edwards, I agree ME is an hypothetical disease but this statement can easily be misinterpreted. ME is a syndrome, a set of symptoms, but until we understand more then we cannot say it is a single disease. It might, for example, be two or more different diseases. While you have said something similar in other places I think its important to emphasize that the ME syndrome might be a mix of different diseases, and each disease would have its own biomarker/s.

I think most of us, using strict criteria, can be divided into two clusters. Most studies fall into something like a 60/40 or 70/30 patient split on findings. Sadly these findings have yet to be compared on the same cohort to see if its a stable result or an artifact or something. Even Rituximab has a 70/30 split.

PS Catching up with my reading I see you answered this a few posts back.

 

[alex3619]

The $1 million dollar pricetag for P2P might be viewed not only as a huge waste of money, but as a political indicator of a willingness to change direction, to go where the crowd is now going, to give the appearance that they are functioning as leaders.

That is one of the possibilities, and I hope this is right. However, there are other interpretations, some of which are not so optimistic in outlook.

It could be that this is another diversion. Give us something to occupy our attention and then we waste yet more years of advocacy.

Or it could be bureaucratic ineptitude, which is so pervasive it borders on universal. This makes it very hard for the best choice to be determined.

Then there is lack of political will - nothing might happen regardless. I might add though that a report like this might be used to support a political argument in our favour, provided that any politician is willing to step up.

The more likely scenario though is that all the above are right. Different factions exist within the NIH and other parts of government, each with their own view. If this is right things will not automatically go our way, but if we are astute and play the political game then we could get results.

 

[Bob]

Any ideas why no such research was proposed?

Re two-day CPET testing, that's a very good point. The two-day CPET test results haven't been consistent in the various published studies and perhaps that's why they weren't mentioned in the report (our perhaps the reason is political) but they could at least have mentioned their potential or recommended further and larger research studies. The studies do need to be replicated on a larger scale, with various control groups.

 

[A.B.]

I had thought that Chris Snell et al. have indicated that the lack of recovery (and in many cases worse performance) on day two of a CPET distinguished ME from other illnesses.

My memory is hazy but the way I remember it this research has mostly used healthy sedentary people as controls. There have been some control groups with other patient groups but this has definitely not been investigated enough to say that it distinguishes ME from other diseases. It looks like it might though.

Asking for funding to be made available for CPET studies that attempt to find out whether these abnormal CPET results are truly unique to ME seems like a fine suggestion.

 

[alex3619]

There have been some control groups with other patient groups but this has definitely not been investigated enough to say that it distinguishes ME from other diseases. It looks like it might though.

While this is correct in terms of formal studies, it misses a critical point. CPET has been around since 1949. It became more widespread around 1963. Sometime later it became ubiquitous in good hospitals. Its been used on many many diseases and problems. So far ME is the only diagnosis with this particular response, or at least the only diagnosis in which this has been noted in the literature.

That is in part what something like a simplistic EBM review would miss.

CPET is not an ideal diagnostic test though. Its a risky one. So, I might add, are things like lumbar punctures. Sometimes the risk is justified, sometimes it isn't.

From a research and not clinical perspective I regard the 2 day CPET as critical. It has the potential to validate ME very strongly. It has potential as a treatment biomarker, and I think it has already been used for this purpose. Its something that should have been covered in the report.