NICE guideline review: A list of appointees to the ME/CFS Guideline Committee has now been published

Physiological improvement in the Fulcher et al study. Patients met the Oxford criteria.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2126868/pdf/9180065.pdf

 

I am not personally planning anything but various people are thinking about this it seems. I can't really say more. It would be ethical to make recordings of activity patterns that indicated variations in activity after periods of effort as part of daily life. Trying to document long term deterioration caused by exercise programmes seems to me unethical.

 

I agree that there is a problem with safety analysis. This is part of the anomaly of therapist-delivered treatments not being subject to licensing requirements. That is something that I hope the guideline committee will consider seriously.

 

OK I'm gonna lay out my reasoning step by step here.

1) I agree that focusing on GET harming patients is the most advantageous thing to do, on the surface -- though I'd counter there are already many reports of patient harms they've managed to ignore by pointing out that patient organizations are the ones reporting them.

2) I also agree that it's unethical to actually force a patient to do GET; the only ethical thing is to use actometers and gather additional data after periods of heightened activity. Maybe call the patient in if their activity reaches a certain level (via step count), draw blood and/or do muscle biopsies, and continue to do draws regularly until the person says they are back to their baseline.

3) Do the same for sedentary controls. See that the blood values differ between these two groups. See that recovery time differs.

Then what, though?

The BPS practitioner tuts and reassures his audience that this sporadic, unguided exercise routine is not what he and his colleagues do at all! Why, NICE guidelines explicitly advise against it!

They'd pivot as they have before: ME is real. Look at those blood values! So different from sedentary controls. Fascinating, fascinating -- these poor maligned people are really sick, you know.

And their illness is best addressed by physician-guided exercise, only physicians can guide the patient to wellness, look what happens when they're left to manage on their own... it's unethical to leave them w/o skilled care.

More funding for GET, please.

Given the ethical considerations, I'm not sure of a way out of this one.

 

Would it be feasible to do a GET actigraphy study of patients attending CBT/GET clinics, but independent of that clinic?

That seems to work around the ethical issue that someone suspecting GET to be harmful cannot in good conscience recruit patients to test that hypothesis. But it appears ethical to act as independent observer monitoring activity levels and safety.

 

Actimetry? (I'm guessing voice-recognition software!)

 

This is what I don't get. When an aircraft, or car, or any engineering project is subject to formal safety engineering control:

• Yes, evidence is required of potential harms.
• No, it is not necessary to actually harm people in order to provide evidence of the risk of harms to people.
• It is only necessary to provide evidence of harmful events that can occur, and the probable frequency of those events occurring.

It would be a bit ridiculous if a plane could only be proved dangerous if you had to fill it with passengers and see how many you maimed or killed, else it is presumed not dangerous.

Surely something equivalent to safety engineering must exist within medicine? If you can prove that harmful mechanisms exist, and the probability of those mechanisms occurring, then surely it cannot be necessary for actual harms to be proven on real patients. The burden of proof for harms should not be the same as for efficacy surely? When it comes to the harms, then the notion of risk being beyond a reasonable doubt should apply?

 

I think the way out may be to make sure the evidence currently available is laid out in an official form for the benefit of everyone. The NICE assessment may provide that opportunity.

 

Historically there has been no systematic basis in medicine and lots of people have noticed. More recently a reasonably systematic basis with post marketing surveillance has been used for drugs. But for therapist-delivered treatments, foodstuffs, surgery and radiopharmaceuticals as far as I know there is still no formal safety net. This needs to be raised as context for the evidence for the committee.

 

Thanks for that .

 

Expensive, intrusive and PAINFUL! Not a good idea.

 

Sharp has already called for more funding to figure out why GET works so well in trials but not in practice.

 

I bet many here could explain him without any additional funding...

 

Well I could tell him that, over a pint of beer, as Simon puts it.

Oops, Cheshire got there first.

 

Somebody send him the PACE study.

 

The difference between studies and what patients report is enormous. In surveys up to 74% of patients report harm from GET! PACE reported problems with GET in 8% (control group 4%).

It is actually not easy to explain. There must be a very strong effort by PACE authors to cover up or prevent harm in their studies. The question is how they do it: by very selective recruiting, by labeling any harm the patient reports as ordinary and expected and not actually harm, or doing some form of GET that is very gentle, or manipulating the statistics, or something else?

 

For food we use HACCP (Hazard Analysis critical control points) which is a safety system to assess risk for products and processes.

There is also a whole raft of other food safety measures and the biggest set of legislature with policing for any product sold. Food stuffs are in no way comparable to medicine in terms of accountability, learning from your mistakes and governance...they are chalk and cheese from what I can see.

 

Yes, I appreciate that there are safety measures for foods as foods. But as far as I know there is no regulation of doctors, or anyone else, recommending foodstuffs to treat diseases. So I could recommend parsnip juice for rheumatoid arthritis without ever having established that there was not some serious adverse reaction that occurred in people with RA to parsnips. There are probably very few examples of this being a problem but I wonder about recommendations for diets for diabetes and suchlike. Was there ever a requirement to prove they were safe. My guess is that they were recommended on theoretical grounds that may have proved wrong.