Aphaeresis/ Apheresis (for removal of microclots)

I don't see any need for hindsight. It is very obvious that people are being exploited right now.
The chances that apheresis is of any use for Post COVID problems are close to zero and there is no evidence. Selling people procedures like this is fraud - plain and simple.

 

@Jonathan Edwards

The evidence I see is personal patient reports of recovery or improvement. Some well known MECFS researchers like Prof Scheibenbogen (in a solve talk on MECFS &LC discussed HELP apheresis as one of the possible treatment pathways) Dr Levine and Dr Proal are collaborating with the project.
I’m watching and reserving judgment.

 

Agree with @Fizzlou. I don't think there's any exploitation or malice here. From what I've read the patients are driving demand and the clinic is not operating from a primary profit motive (c.f. IncelDx). Apparently they shared all IP and formed a network with 20 competitor clinics in Germany to try and handle the instantaneous load. It was commented that in the German healthcare environment this type of co-operation was extremely unusual.

Part of hindsight might be about how to navigate the ethics. How do you handle accidentally finding that an established procedure is now (anecdotally) significantly effective against a "new" disease?

This is why I think the clinic inadvertently painted themselves into a corner. Their established patients would be continuing the treatment for the condition they were originally prescribed regardless, so they're not stopping even if cured of LC. The LC symptom improvement is undeniable in the eyes of the clinic doctors. They resolve to evaluate some LC patients. But before they can publish even their early findings, the patients are increasingly lining up at the door.

But now the doctors know (unpublished) that the procedure is undeniably working. Not just helping a few and helping a bit, but really working and in very many. That seems ethically challenging and the best way forward may have been thought to be (Jonathan Edwards' least favourite word) pragmatic.

 

And those are parts of the problem.
My job here is to try to help people distinguish real science from fashionable talk that sounds like science to the general public.
I don't see real science here. And I don't speak as someone wedded to starchy establishment views. I wouldn't be here if a was.

 

Maybe you have missed the main topic of conversation on this forum for the last four years?
Which is that symptom improvement being undeniable in the eyes of clinic doctors has been grinding PWME into the dirt for decades and we need something real.

If we accept this is bona fide then all of the critique of the BPS charade might as well be flushed down the toilet

This is just as bad.

In other words. We have to have a level playing field. Stuff that sounds sexy is not what is needed. Stuff that is based on reliable evidence is what is needed.

 

By behaving like scientists? This must have happened thousands of times, but until you do a blinded trial, it's completely meaningless.

It's not only unprofessional to sign people up for something with no evidence to back it up, it actually risks creating an impression that the therapists are cowboys and the treatment is hype. Who's going to fund them to do a proper trial then?

 

I’ve seen some screenshots from a Facebook group that made me pretty upset. (I won’t share them here because I’m unsure if they were allowed to be reposted in the first place.)

it appears that there are clinics offering this apheresis as a part of a complete “protocol”, and that patients are warned that they will not get better unless they “fully commit” to a protocol that includes supplements, intermittent fasting, “staying positive”, among other things.

I understand how the hype snowballs but it seems that we have fully put the cart before the horse.

I am also worried that anyone with long COVID is by definition still in the early stages of illness and has a higher chance of a “natural recovery”. How many of these patients are going to mistaken for evidence of XYZ treatment being a miracle? I would also be a lot more interested if people were indeed reporting near-full recovery after a few sessions of apheresis. But even the model patient, Dr. Khan, has done upwards of a dozen sessions and is still sick?

 

I do not have good understanding of what is actually happening at these clinics and with the patients. Maybe the treatment is undeniably working for some patients. If this is not the case and the effectiveness is still uncertain then treatment with apheresis outside of a clinical trial seems very questionable. Especially when it's expensive and invasive.

 

https://meassociation.org.uk/2021/10/a-new-treatment-for-long-covid/

With >100 patients treated already, the clinic should have published at least some very preliminary report describing the effects.

 

Sorry if this has been covered but are there any good or even reasonable trials of this going on? (Sorry I didn't understand the position). If something is working so well, and there are so many patients lining up, why wouldn't you do proper trials? Has it just not happened yet or is it underway alongside the many others doing it on a speculative basis?

 

Private doctors were offering Rituximab privately for 10k a time before the blinded trials were finished, even though they were asked not to. Doctors are performing expensive and damaging spinal surgery. Now we have this. It's a pattern we are sadly seeing regularly - going straight from anecdotal improvements to expensive and potentially devastating treatments. The private doctors offering them rarely seem to publish their track record, either because they're too busy or it's too difficult or takes too long to get published or some such similar excuse.

Prof Scheibenbogen should have learnt from her experiments with Rituximab what can go wrong:

ME/CFS Doctors in Germany

The work of Amy Proal has been discussed on the forum before. You can form your own opinion of the quality of her research by reading this thread:

https://www.s4me.info/threads/hypothesis-piece-by-amy-proal-a-microbiologist-with-me-cfs.134/

After 8 years of this illness I'm of the opinion that many of our "well known MECFS researchers" are a very mixed bag and often disappoint. Sadly they are all we've got, but the times I've seen a new researcher appear trumpeting great hope, followed by exciting updates then by everything going rather quiet within a few years...

Flug and Mella were exemplary in their approach and the patient community appreciated it, even when it led to a null result. I haven't seen many other researchers / clinicians practising science to those standards. Now when the next great new thing comes along I just hope that too many patients don't get hurt or stripped of their savings.

 

Thanks @Hutan, it has been a little rough lately.

I find this a very unusual situation for all the reasons we've discussed above. This will (I hope) be my last post on this subject until formal scientific reporting occurs. It appears this thread has not been helpful. I think I have not done a good job with my part in this discussion and I regret that. I started this thread as an offshoot from these new findings related to long COVID. I wanted to explore what the implications for the micro-clot finding could be, in terms of a potential disease mechanism in ME. This was fascinating to me and I could see how it might all hang together, based on what I had learned and my own (admittedly short term) disease experiences.

However, it's been too easy to keep wondering what on earth is happening with the apheresis treatments. Unfortunately, so much of that story is opaque at the moment. I have tried to summarise what is being described elsewhere and draw inferences about the situation, assuming best intention from those inexperienced in LC (and ME) who suddenly found themselves deep in it. These were clinicians with (presumably) no pre-conceived notions of what LC/ME was and they weren't massaging data to support some flawed disease model - psychogenic or biological. There also appear to be significant difficulties in blinding for this type of treatment.

Given that this was so fast-moving I thought it was also good to report what was being said/written - though again, through a frosted glass. It might have been better if I had not tried to defend the situation as it appeared to me.

Regardless, if this did subsequently turn out to be an inflexion point in ME research, this forum's summaries and comments might help historians/authors to review the timeline of events.

I would prefer to get the horse back in front of the cart. For my part, I am pleased to now be involved in supporting the basic scientific research into the cells and proteins associated with inflammation and coagulation in LC/ME (all needing rapid upskilling for me, of course). In my own area, if my situation allows, I would also like to arrange for some targeted imaging studies to try and answer some fundamental questions on fatigue and PEM, and potentially how they might relate to red cells and vessels. Perhaps one day you might even discuss a short paper and I will excuse myself from the room.

In closing, the micro-clot finding from the South Africa / Liverpool team and the apheresis finding from the German clinic have drawn in new researchers into LC (and presumably by extension ME). New researcher blood seems a good thing and perhaps old ideas that were inappropriately left unloved will now have their time in the sun. Leaving aside the many unknowns of the apheresis, I maintain confidence that the biological science researchers are approaching things methodically and appropriately. I would also expect that drug therapies will be similarly evaluated on the clinical side.

[The moderators may wish to consider closing this thread and starting afresh with published data when / if it appears.]

Copied post: Some responses to this post are on the thread considering the microclot hypothesis.

 

You must forgive us for a bit of a pile-on in response to some of the apheresis stuff, @SNT Gatchaman! Some of us have just been watching similar stories play out for decades. Many of us (me included) would have been much more excited about it the first time round.

It's actually got worse with the advent of social media. Previously, finding were discussed in newsletters and on message boards, and it was often patients themselves who got carried away by compelling-sounding theories. Nowadays, the researchers are reporting results on Twitter, and I'm guessing they're ill prepared for what happens when an idea gains momentum and then runs away.

Add to that a large population of well-networked new patients, who haven't had the experience of seeing 10–15 equally plausible sounding theories or treatments announced with a big fanfare, only to disappear into obscurity. When sick people are clamouring for a new treatment from the practitioners who're involved in testing or developing it, it must be difficult at times to spot the beginning of a slippery ethical slope—especially if the idea is picked up by groups other than the one who first worked on it. Once the genie's out of the bottle, they've lost control.

 

There's a consistent message on this forum that unblinded/inadequately blinded trials are fine (they seem to be normal in psychological interventions) but you must use objective outcome indicators such as actimetry (FitBit type devices), [EDIT - in these cases]-----. OK if you can blind, and use objective outcome indicators, then that's better.

I've been through the mill myself --- par for the course and you seem to be OK with it --- good. I think we'd rather find out the flaws in something rather than promoting/accepting something which isn't going to improve the quality of life.

 

Perhaps a red herring, but there is also the cultural meme, spread in films and TV dramas, that if you have a currently untreatable condition the best course of action is to become a trial subject or look for an experimental treatment in the early stages of being developed.

I have no objection to people participating in experimental interventions as long as those providing it are clear about risks and the evidence, expressing unambiguously the difference between logically possible benefits and what we currently know, and that those participating are able to objectively asses potential costs and the current evidence base or lack of it.

To allow such experimental interventions to take place ethically we also need some way of preventing over enthusiasm from the clinicians and patient desperation as factors clouding judgement. (However how possible is this in practice?)

 

I suspect it isn't, if there's no external ethics approval and participants have to pay for the treatment. Research projects take a strict approach to those issues for very good reasons.

Patients can be really poorly placed to assess risks unless they're getting unbiased information. Apheresis might sound relatively benign, but it's still invasive and there could be serious adverse effects if it's not done properly or patients aren't monitored properly afterwards.

The fact that treatments like this aren't keyed into patients' usual primary care systems is another potential risk, particular in countries with socialised healthcare. What happens if you develop some weird deficiency or circulation problem weeks later, and either you don't have enough knowledge to connect it to the treatment, or your GP has no idea how to access information from the clinic to help them work out what's going on?

 

https://twitter.com/user/status/1460706606908416002


I really dislike this "#teamclots" stuff