11 minutes ago, exchemist said:

But Harrop represented himself as an individual down on his luck, living in his car and "sentenced to a slow death" due to lack of timely access to FMT to fix his CFS. Whereas in fact he has been running a dangerous business trading stool samples without appropriate medical oversight and promoting excessive claims for the utility of this largely unproven therapy. And he wants us all to join in his crusade.

As for donor quality, to judge by the comments of @SFBayFMT5 Harrop does not have much idea of what constitutes an appropriate donor for a particular case - unsurprising as he has no medical training.

If he wants to go about this the right way, he should team up with a gastroenterologist with a research interest in this area and do some proper scientific work, with a professional safety net for the participants in any trials.

"Was running" or "had been running", not "has been running" since he no longer runs anything.

1 minute ago, Otto Kretschmer said:

"Was running" or "had been running", not "has been running" since he no longer runs anything.

And a good job too! Was he prosecuted?

Moderator Note

There are a lot of links going back to the Human Microbes site; our rules on advertising state “We don't mind if you put a link to your noncommercial site (e.g. a blog) in your signature and/or profile, but don't go around making threads to advertise it.” so whether it’s commercial is immaterial.

Any insistence that someone go to another site to gain information need to participate in a discussion also runs afoul of the rule

Also, any history of what happened elsewhere is moot. Please stay on topic.

3 hours ago, exchemist said:

But Harrop represented himself as an individual down on his luck, living in his car and "sentenced to a slow death" due to lack of timely access to FMT to fix his CFS. Whereas in fact he has been running a dangerous business trading stool samples without appropriate medical oversight and promoting excessive claims for the utility of this largely unproven therapy. And he wants us all to join in his crusade.

He IS "sentenced to a slow death" in many ways without access to this treatment, as am I. We would all like to have more access to this treatment, due to the success we have had in the past. And unfortunately, it's illegal for gastroenterologists in the United States to offer this treatment for anything other than C. diff. Laws in the rest of the world vary from banned like the US--for instance in Canada--to not forbidden but not officially legal either, like in Asturias, where their manufacturing process has legal oversight just like any other supplement or drug manufacturer but there is no official sanctioning of the product itself, to legal and regulated, as in Australia. That's the situation we're in.

One person on another forum compared the situation to medical cannabis in the early days--patients reporting significant benefits but no official channels to obtain it. And you had evangelists there too, people claiming it was God's medicine that would cure all disease and create world peace on top of it. The more underground a product is driven, the more it rewards people for being unscrupulous rather than honest.

3 hours ago, exchemist said:

As for donor quality, to judge by the comments of @SFBayFMT5 Harrop does not have much idea of what constitutes an appropriate donor for a particular case - unsurprising as he has no medical training.

Unfortunately even the doctors don't have much knowledge of this except for in the case of C. diff. This requires trial and error, that's why there's a thriving web of forums for people to review different donors for different diseases (not just Harrop's product). Some people use family members or partners--there's a famous case of an Australian man who cured his bipolar disorder by using his girlfriend or wife, and another case from somewhere (may have also been Australia) of a woman with bipolar who was cured using her boyfriend or husband. However, others find that non-family members work better due to the lack of shared genetic vulnerability.

So yes, it's disingenuous for ANYONE (even a doctor) to claim that this is a "solved problem"--this is a case of "the more data the better". And Harrop has been at the forefront of promoting this kind of data sharing, even if he then hallucinates that the data shows something that it doesn't (and of course this doesn't make making unsupported claims ethical).

3 hours ago, exchemist said:

If he wants to go about this the right way, he should team up with a gastroenterologist with a research interest in this area and do some proper scientific work, with a professional safety net for the participants in any trials.

A researcher at Arizona State has been doing this as a clinical trial for people with autism. These trials are VERY difficult to get into--I contacted them and there was no space left. And who knows when their treatment will become available. And then you still have the question of, what happens if you have a patient who doesn't get better with a particular donor/method who might improve dramatically with a different one? It seems I lucked out by the first FMT I got for C. diff being exactly what I needed for my other conditions as well, whether it's the donor that's to credit or the pre-treatment or something else--we don't want the treatment as a whole to flounder if people don't get an effective donor or supplier the first time. One of the donors I tried DID make me worse--luckily it was my fourth and not my first so I knew it was just that donor.

4 hours ago, SFBayFMT5 said:

And unfortunately, it's illegal for gastroenterologists in the United States to offer this treatment for anything other than C. diff. Laws in the rest of the world vary from banned like the US--for instance in Canada--to not forbidden but not officially legal either,

I don't think it is illegal in either jurisdiction, but any use beside treatment of clostridia is considered off-label. These are generally not covered by insurance and many just won't do it because of practical and liability issues. But not being approved is not the same as being banned. Trials are one pathway were off-label use can be tested and funded, and a prerequisite is that they are not banned for that purpose (there might be ways to get an exemption but I am not sure).

4 hours ago, SFBayFMT5 said:

A researcher at Arizona State has been doing this as a clinical trial for people with autism.

A big issue specifically related to autism is the paucity of placebo data for FMT. There is longish history of a strong placebo effect on the treatment of autism with sometimes really high effect sizes (One recent review is found here https://doi.org/10.1111/dmcn.15574). So much in fact I am wondering whether placebo treatment shouldn't be on the table. After all, if symptoms lessen and the folks feel better, why not do it even if we do not really understand why? After all, if FMT provides relief, we also do not really know, we mostly speculate).

19 hours ago, SFBayFMT5 said:

Among people I know about (including myself) who HAVE been able to compare Harrop's FMTs with other suppliers' FMTs by firsthand experience, we have found that his FMTs are roughly comparable to what you get elsewhere on average

This is not true. The number of people who get worse from other sources is vastly higher than from HMorg's donors. And much of the poor results from HMorg's donors are because I let people continue using whatever donor they like, since all results are public, so people are making informed decisions about risk vs reward.

On 7/26/2025 at 4:19 PM, CharonY said:

I don't think it is illegal in either jurisdiction, but any use beside treatment of clostridia is considered off-label. These are generally not covered by insurance and many just won't do it because of practical and liability issues. But not being approved is not the same as being banned. Trials are one pathway were off-label use can be tested and funded, and a prerequisite is that they are not banned for that purpose (there might be ways to get an exemption but I am not sure).

It is banned in the sense that any doctors who would use it off-label, outside of a clinical trial, are risking sanction from medical boards. Clinics that provide FMT are operating in a gray zone where they could be shut down any time--it's not just that the patients have to pay out of pocket (which they do).

2 hours ago, SFBayFMT5 said:

It is banned in the sense that any doctors who would use it off-label, outside of a clinical trial, are risking sanction from medical boards.

Are there any specific statutes that apply to FMT? If not It seems to me that the risk is similar to other off-label prescriptions. While off-label use has led to sanctions from medical board in the past, they were usually careless administrations, without proper consideration of risk and/or lack of informed consent. Now, it is true that if there are negative outcomes, there could be consequences and the medical practitioner (such as lawsuit). However, liability insurance does cover off-label use there, too. The only exception I am aware of is if there was gross negligence involved.

IOW, unless there are specific guidance of FMT in terms of off-label use, I think it should fall under the same. I am vaguely aware that Vowst has been tested outside of a clinicals to (unsuccessfully) improve inflammatory bowel diseases and I do not think that there were extra documentations as for clinicals required.

46 minutes ago, CharonY said:

Are there any specific statutes that apply to FMT? If not It seems to me that the risk is similar to other off-label prescriptions. While off-label use has led to sanctions from medical board in the past, they were usually careless administrations, without proper consideration of risk and/or lack of informed consent.

I believe in the US, the FDA classifies fecal microbiota transplantation (FMT) as a biological product and drug, which means its use is regulated under those frameworks, from the limited knowledge I know I believe it is regulated generally with no regulations “specific” to it

Yes, which is why I am a bit skeptical that their off-label use would be illegal. Especially as the FDA-approved FMTs (such as Vowst, but I am sure the rectally applied one is similar) have no history of serious side effects, and there are far more critical (legal) off-label uses of more harmful medication.

What could be the case is that some physicians don't like to make off-label recommendations, as there is more uncertainty. But again, I don't that legal nor board sanctions are likely in this case. That being said, I imaging that doing FMTs from donors is a bit different- after all physicians have no real experience in creating safe formulations. Unless they have a certified lab and provide all the documentation, QA/QC and permits, it is likely not allowed as treatment. There is a potential grey zone if they label it as supplement rather than treatment. That area is a bit a of a wild west out there.

The FDA is classifying FMT as an "unapproved drug". "Off-label use" only applies to approved drugs, as far as I know.

I don't think Vowst is comparable to FMT. It's a human-sourced, multi-strain probiotic that has been granted drug approval since it successfully treats C. diff. It's something like 50 species of spore-forming bacteria.

Any doctor who wants to do actual FMT would need an IND.

9 hours ago, Michael Harrop said:

The FDA is classifying FMT as an "unapproved drug". "Off-label use" only applies to approved drugs, as far as I know.

I don't think Vowst is comparable to FMT. It's a human-sourced, multi-strain probiotic that has been granted drug approval since it successfully treats C. diff. It's something like 50 species of spore-forming bacteria.

Any doctor who wants to do actual FMT would need an IND.

While Vowst is FDA approved and standardized, it is still derived from screened human donors, just like conventional FMT. The main difference lies in formulation and delivery. Vowst contains around fifty species of spore forming bacteria, but that is only a subset of the much broader microbial diversity found in full spectrum FMT. In fact, Vowst was developed specifically to mimic the therapeutic benefits of FMT while offering more consistent dosing and a reduced risk of transmitting pathogens. Its clinical trials used FMT as a comparator, and the FDA approval was based on its success treating recurrent C difficile infections, the same condition for which FMT is widely used.

In addition there is a rectal treatment (Rebyota). Both are human microbiome-derived. IND would be required for approved other uses, but otherwise it should not be different from "regular" off-label use. So using FDA-approved treatments, is obviously the easiest option due to the standardization and available safety information.

Now if you want to use stool banks, the issue is more complicated as they would fall under biologic drug regulations, which will differ from jurisdictions. At minimum there must be documentation of the screening procedure and outcomes but there is bit of a regulatory gap in the FDA (or there was a decade or so ago) which basically allowed FDA discretion. It was only really catered for Clostridium difficile treatment, as they considered that more of an emergency situation and the risk/benefit was rather obvious there. But for other uses and given the relative paucity of trial data, I would assume IND or equivalent pathways would be necessary (AFAIK FDA and similar agencies only issued statements regarding C. difficile but have not mentioned other uses, but I may be wrong). I am vaguely aware of the struggle of OpenBiome, and the fight over regulations (though I think they submitted INDs by now).

In Europe the legal framework is flexible, meaning that member states have significant discretion in how they regulate FMT. From what I have heard, it is a bit of a mess how FMT are classified and different monitoring criteria (e.g. donor selection vs microbial composition). From second-hand info it seems that at least in some countries it would be easier to conduct research studies on FMTs, but we really never got into details.

6 hours ago, CharonY said:

In addition there is a rectal treatment (Rebyota). Both are human microbiome-derived. IND would be required for approved other uses, but otherwise it should not be different from "regular" off-label use. So using FDA-approved treatments, is obviously the easiest option due to the standardization and available safety information.

How is requiring an IND filing at all similar to regular off-label use? Using regular drugs off-label just means that a medical professional believes that the drug could be helpful for a condition other than what the FDA approved the drug for--it doesn't require any further FDA approval of the use. So if Rebyota is approved in such a way that limits it only to one particular use without filing additional paperwork with the FDA, then that is a very UNusual type of "conditional approval".

Sorry I wasn't clear, it was just to re-affirm that for FDA (or equivalent) approved use it would be IND, but the other pathway (i.e. without formal approval), would fall under typical off-label-use. I.e. the physician has to be able to defend the use, but does not require formal approval.

1 hour ago, CharonY said:

Sorry I wasn't clear, it was just to re-affirm that for FDA (or equivalent) approved use it would be IND, but the other pathway (i.e. without formal approval), would fall under typical off-label-use. I.e. the physician has to be able to defend the use, but does not require formal approval.

That sounds odd to me... so using it for a condition that it's already been approved for (i.e. for its "intended use") actually requires more paperwork than using it off-label for another condition?? Or are you saying that in order to GET it approved for a new use (such that, from then on, such use is no longer considered "off label") requires an IND?

Edited July 31Jul 31 by SFBayFMT5

4 minutes ago, SFBayFMT5 said:

That sounds odd to me... so using it for a condition that it's already been approved for (i.e. for its "intended use") actually requires more paperwork than using it off-label for another condition?? Or are you saying that in order to GET it approved for a new use (such that, from then on, such use is no longer considered "off label") requires an IND?

No let me try to clarify this:

Already approved use -> normal usage no additional paperwork

Off-label use -> no "formal" paperwork but physician needs to demonstrate that they have at least informed consent from the patient

Obtaining Approval for not yet approved use -> Investigational New Drug approval application, typically an Investigator IND if the physician is administering and monitoring the treatment.

3 hours ago, CharonY said:

No let me try to clarify this:

Already approved use -> normal usage no additional paperwork

Off-label use -> no "formal" paperwork but physician needs to demonstrate that they have at least informed consent from the patient

Obtaining Approval for not yet approved use -> Investigational New Drug approval application, typically and Investigator IND if the physician is administering and monitoring the treatment.

That makes perfect sense thanks.