Claim (PACE) ME/CFS cured by changing mind on way out HealthInsightUK Blog post by Jerome Burne (2019)

http://healthinsightuk.org/2019/04/...emed-bizarre-now-it-really-is-on-the-way-out/

So glad he has taken up the mantle and run with it!

 

Nice work.

 

Busting the dam with a thousand hairline fractures.

Hard to say which one will make the structure collapse, but it all adds up.

A bit silly that it takes so much to bring down a dam mostly made of a mix of tarot cards and beaver spit and already leaking like a sieve but here we still are.

 

Great article. On another thread, or threads, members have asked what do the CBT/GET crowd believe. Mr. Burne said these researchers say they are not committed either way - whether ME is organic or psychological. However, he indicates the PACE trial itself and the accompanying CBT manual say there is no underlying disease process, and no reason pwME ("cfs") cannot regain their physical function.

 

Me too.

But i’m thinking that 12 months or 2 years ago, we would probably have been even more thrilled. Does this indicate that we know at some level that the argument is mostly won?

My nervousness lies around the NICE guidelines. I have real concerns about the composition of the Committee and if it goes wrong, it will be a devastating blow.

Maybe I should be more positive.

 

I don’t think being unduly positive is helpful. We have good reason to expect the worst, after the last time. However I think they have been pushed a bit further into a corner this time with much more public critiques of the status quo. I am hoping for improvements but expect there will still be aspects we don’t like. I do hope and pray that GET will be consigned to the bin. If not we will have to literally riot, but how?!

I think we need to set up our own version of the Science Media Centre for ME, though we don’t have the money/connections! It would need a catchy name to get journalistic attention. Something about evidence and also makes a good acronym (if that’s the right term). We could have fun working through the options! Then at least we could raise our voices a little higher.

 

I absolutely agree that NICE is not to be trusted, nor the RCP the Guideline developers ..... operating behind closed doors....and NICE is being 'superceded" by NHS England and NHS Improvements it would appear.

The whole process is a set up!

So I will make a first Suggestion.


How about CRAP?

Centre for Reliable Assessments and Process?
or
Centre for Reliable Assessments & Protocols?

We could ask journos, " Will you sign up to CRAP?'

Meanwhile, this has just popped up from Bristol Group.

Deadline for submissions is May 1st.
ninds.nih.gov
Request for Information: Soliciting Input on How Best to Advance Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Research | National Institute of Neurological Disorders and…
https://www.ninds.nih.gov/RFI-NANDS...-lsUnymCH7wx90PeN_pczOf8UUsHHxD8xFZkhg_AhO0-c

 

Scary. I immediately submitted some comments about CBT/GET and low standards of evidence holding back scientific progress.

 

Scary why? We've had a thread on the RFI for a while now, https://www.s4me.info/threads/nih-r...-on-how-best-to-advance-me-cfs-research.8592/

 

I read the comment about Bristol and immediately thought of Crawley and co submitting comments to NIH. That is scary. Although Bristol group could also refer to a patient organization. Either way it's good to keep pointing out that CBT/GET are based on science that wouldn't be accepted if it was a drug.

 

I'll chime in here, simply because I once did get into the scrum about PACE. I was willing to admit it might work on some patients, but the number benefiting by my count was about two. The number harmed, by their numbers was zero, but that required defining a new category in which doctors could dismiss patient complaints as unjustified. I do know that there were twice as many reported setbacks in their own data before applying these opinions. I have no idea of how many patients in the original trial were harmed by GET, but at least two who said they took part appeared on ME/CFS forums saying they had long-term setbacks. It is quite possible the number harmed was equal to the number helped, making the therapeutic effect a complete wash. This is fully consistent with the only objective measure (step test) available for all patients, not just those who felt like taking a test. Ignoring patient complaints, you still get a null result.

We then get into a bizarre claim from those backing the trial. They claimed some were made better, but they had no way to predict which this would be. Based on their own data this might be 2, instead of the 640 they were touting to journalists, the vast majority of whom never received the treatment promoted, and none of whom received the combination of treatments claimed to to be ideal, base on results from the trial. If this did not constitute fraud in a scientific sense, it certainly did in terms of publicity.

If you don't know who will be made better, then ignore those who are made worse, and you insist on applying this to the whole undifferentiated cohort of patients, to me it seems that you are more interested in the benefits to those performing the treatment than to those receiving it. This kind of criticism is based on internal contradictions, which don't require any outside efforts to replicate, should be especially devastating.

I will add my own opinion that they did not run the physiological tests necessary to distinguish various potential problems in the study cohort, they just assumed conventional medical work-ups were perfect in identifying patients with unexplained fatigue from physiological causes. Just in terms of the patients I know, there have been several different medical problems thrown into the same wastebasket. Some of these were potentially lethal (cancer). Some (anti-NMDA receptor encephalitis) would result in long-term confinement to a psychological back ward if not treated correctly. I don't believe the PACE researchers ever had a uniform cohort. When detailed analysis of data results in numbers you can count on one hand, you cannot rule out the possibility that these were all the result of misdiagnosis. You could show that 10% improved, and still be fooled by pure random variation. It has happened before. They didn't come close to even that low bar.

Why are we just now getting to the point of a shift in medical opinion?

 

re the statins issue (also raised by Burne)
https://twitter.com/user/status/1119898695921799168

https://twitter.com/user/status/1120312650498494464


uncanny parallels

 

Dr Aseem Malhotra
@DrAseemMalhotra
Dr Aseem Malhotra
This guy is awesome!

 

On the statins issue, I don't have much background, so I'm going to ask others about their experiences. I know several people who benefited from statins, though generally much younger people than over 70s. I've also encountered several people myself who were "treatment intolerant" when given statins. There are degrees of this, though the worst responses were far more than simply not liking them. At a time in the past I was told nobody knew why some people were "treatment intolerant" or how to predict which patients would have adverse responses. Rolling out widespread treatment without understanding this seems unwise. Failure to track adverse responses after approval is a regulatory failure.

Personally, I think there may be a pattern to intolerance of statins, but don't know what this is telling us. Anybody have an answer based on people you know directly?

 

It would be helpful if we could have guidelines as to the circumstances in which commercial interests are deemed to be of paramount importance.

 

Have followed this for years to family/friends problems-
Malcolm Kendrick's book is good and for older people Beatrice Golomb, MD, PhD, professor of medicine at University of California San Diego School of Medicine research is good.
Statins can cause muscle breakdown and COQ 10 was recommended in the clinical trials to help offset this but of course you can't get that on the NHS nor is it routinely advised. https://www.sps.nhs.uk/articles/sho...o-reduce-the-risk-of-statin-induced-myopathy/

 

As usual I can't remember the details but statins work by interfering with a precursor of cholesterol but that precursor also either becomes CoQ10 or something else needed for mitochondrial function.

 

I have a relative whose undiagnosed muscle issue was made significantly worse by statins. Also developed Diabetes...

 

This is the kind of thing I was thinking about. The fact that there was no drop in mortality in patients over 70, but apparently some benefit for patients who are younger and more vigorous, suggests to me this could be an unplanned experiment revealing one of the factors in aging. Loss of muscle mass and function is a well-known problem in geriatric medicine. More detailed analysis might also reveal a shift in causes of death indicating cardiovascular trouble, the very thing these drugs were intended to prevent.

Based on no more than anecdotal evidence I'm guessing patients who end up on this forum are already more likely to be intolerant of treatment with statins because they are reporting problems associated with exercise intolerance and poor muscle function prior to taking them. If this is true it could be a useful clue to the pathology of both ME/CFS and aging.

You might reasonably expect that researchers would consider this an important clue, but be disappointed. Instead people are arguing that prescribing these drugs was not a mistake, even though they fail to benefit, and may harm, a large subset of patients. The core of the argument is that prescribing statins is easy, and it is too much trouble to differentiate those patients who will be harmed. It appears to me that this is an argument about convenience.

 

Doesn't help that GPs are being performance paid to push statins........ In 2010, my mother in law's GP was brilliant and agreed with our concerns and took her off against cardiac specialist consultant advice.
I sent him the Beatrice Glomb research, APRIL Charity medical advisors telephone number and an emeritus professor of medicinal chemistry who's wife was a pharmacist to back up my info!