The Observer/Guardian article: Does the microbiome hold the key to chronic fatigue? About patient led 'research' group Remission Biome.

If health care providers are 'supervising' they legally require ethics committee approval.
Until there is a clear indication why not I think we can assume that this project is illegal. Or at least any health care provider supervising is likely to be disciplined or struck off.

It needs formal written consents, approval for data storage, overall ethical approval and so on.

I am very surprised that Nicola is not aware of this.

 

Is this a UK or US based project? The application form gives costs in USD.

 

Ah, OK. But I imagine the US has laws about ethical board approval too.

The more I look at it , the more it looks like a way to get suckers to part with shedloads of money.
Maybe the Guardian should look at its ethical rules.

 

Why did The Observer/Guardian publish this article? It does not mention the research on gut dysbiosis by Carding in the UK or the comeback study on FMT in Norway. It almost reads like an ad for Remission Biome.

 

I'm very conflicted about this project. I'm pretty sure further down the road it will become clear that there are a lot of problems with it. But the claim of being able to repeatedly induce a major improvement (in the same people) is hard to ignore. I suspect the cause for most reported major improvements in ME/CFS patients are fluctuations of the illness independent of any treatments. It seems difficult to use this explanation in these cases.

A better approach would be to seek independent study / testing of known responders in collaboration with qualified researchers. Establish that this is really happening in a reproducible manner in some people. Then figure out why.

 

The author is a freelance writer based in the US. He may have been asked to pitch by Remission Biome.

 

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It seems that the Guardian adheres to a glorious conception of supporting the underdog, even when the underdogs are professors of psychiatry working for insurance companies or people running crowdfunding scams for 'self-experiments'. Frances Ryan tries to steer them towards the real underdogs but without much success sadly.

 

But frustrating that the ME/CFS community has been trying to get accurate info in the newspapers about problems in ME/CFS healthcare or interesting research studies while being ignored by editors. But when there is a US group doing experiments without ethical approval, it is suddenly fine to publish about it.

 

I don't expect much out of this, but I have no issues with the lack of ethical approval. Most of what happened in the early days of the AIDS crisis had no ethical approval, was even explicitly illegal. We have seen what gets ethical approval, and little of it is actually ethical. It's merely a bureaucratic step, means nothing. We are way past the point where this matters anymore, millions are being left to rot and die in completely immoral indifference.

If it pans it, it pans out. If it doesn't, it doesn't. But the entire system being paralyzed and refusing to do anything is what leads to experiments like this. I doubt it will give useful answers, but experiments like this will continue to happen as long as healthcare systems and medical institutions treat us with contempt and indifference. They are fully responsible for this, denial has consequences. Even if they don't want to help directly, they could have stopped blocking everything long ago. This is all on them.

I'm not condoning it, I just have no issues that it's happening. Better than this than a hundred more CBT BS like we have been subjected to for decades. Far, far better. It would be very easy to make this ethical. It's pervasive refusal at this point, and it's so far below unethical and straight into immoral territory.

Medical systems are leaving us to rot and die. They have no say in what is ethical or not, not anymore. They abandoned this long ago, made it official when public health officers and doctors were gloating that only vulnerable people were dying and that it made it OK to make them die in even greater number, all while disabling millions more who became vulnerable and thus expendable. Those systems may have authority, but they have waived their legitimacy.

 

Observer corrections and clarificationsUK news
For the record

 

I should be invoicing the Guardian at this point.

 

Patients pursuing treatments that may leave them worse off doesn't bother me, in and of itself, and I think generally that there is value to the idea of citizen science, that patients can advance knowledge through careful experimentation, but I do think it matters that patients are given as rounded an assessment of a potential treatment as possible before they jump in. I'm also not sure that the only outcomes of patient organized trials like this are success or not success. We all know with PACE that a badly organized trial can reshape perceptions and realign research directions in ways that cause harm. It's also very easy as a patient, with the variability of the illness and the quite often small impacts we're being asked to quantify, to feel initially that a treatment has helped, making follow-up important.

My wife and I have been testing out nicotine patches, as part of the loose LC patient self-experiment. The harms seemed minimal enough -- and indeed have been, with, for me, worsened sleep, general slight worsening of symptoms globally akin to consuming caffeine daily, and development of an unusual, off-putting body odor -- so I decided to give it a go. As part of that, I filled out the survey that organizers of the Nicotine Test created (which includes, at least some of the organizers of Remission Biome). I found the survey to be confusing in parts, conflicting in others, and with questions that are weighted in problematic ways. I was also alarmed that the survey asks respondents whether they had "remission events" -- terms developed by the Remission Biome group -- but does not define those terms with any degree of clarity.

If this survey is a window into how the Remission Biome group will study patient responses in the 50 person antibiotic and probiotic regimen they're trying to organize, it's a worrying one. Particularly as the group continues to make strong pronouncements about the benefits of their regimen. One recent tweet claimed "Cessation of sickness behavior does not mean 'no damage'. The #Renegade50 WILL experience reductions or complete cessation of sickness behavior. If they act like they are suddenly not sick they will crash and potentially undo progress." Others are similarly biasing.

 

I fully agree. This is what the Long Covid patient community has been demanding on day 1. And us for literally decades.

And it is always rejected. This is the only reason this kind of experimentation is happening. The medical profession is entirely to blame for it, they leave desperate people to rot in plain sight, oftentimes mocking our suffering, there is no other possible outcome to this criminal negligence.

We're still seeing the same thing with the microclots hypothesis and the HELP apheresis treatment, which in my opinion should be evaluated separately. Apheresis as a treatment had some early hype, but that hype has died down as it became evident that it wasn't effective. Microclots are still talked about plenty, but I only remember of a single mention of apheresis in the last year. The patient community does not hold on to failed treatments, only failing charlatans do.

A recently published Cochrane systematic review was published the purpose of dismissing it whole, even though this specific treatment means little about the hypothesis. It was written by a prominent Long Covid denier who rejects any and all research on LC. The same cycle of "you need to this properly, we need to approve any research", "do you approve of any more research?", "no, we reject the very need for researching this, only mind-body BS" is continuing. This is excessively cruel, and entirely the result of medicine's failure.

Desperate people do desperate things. In our case, our despair is simply reattributed as its own cause. Hence disastrous failure. Can't blame patients for this. Even though I see little value in this specific biome hacking research, there is nothing wrong with it, the people responsible for this are the ones derelict in their responsibilities.

 

Yeah, I agree, it’s a product of larger forces, and maybe we need this kind of thing as a general kind of statement, maybe the value is more political than scientific, but I tend to think this kind of work probably would have even more impact if approached a bit more carefully.

In regard to the antibiotic theory, my onset followed Giardia, and many rounds of antibiotics, used both for the parasite and more recklessly months before when I had stomach illnesses traveling because I didn’t know better. But I also had a lasting partial remission once from antibiotics. I’m definitely willing to believe something might be there, but I also know you can lose a lot tinkering with antibiotics and the microbiome. If patients are taking those risks, I’d really want both for them to go in eyes wide and for any results to accurately reflect their experience. I think that can be said without putting ultimate weight for any harm on patients.