Duplicating FMT, stool donor, and microbiome projects vs solving existing barriers Other

[Aim for NaN]

So what are you doing to help make safe & effective donors available?

I see lots of people making statements like that about how bad off they are and how badly they need FMT, yet virtually 100% of them are completely unwilling to lift a finger to help themselves. Most of them use whatever bad donor is most easily available, and get worse.

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Building a website to not only inform people of all kinds of things, but also make a marketplace of stool donors. The website is still work in progress and is heavily being developed. Progress is slow because it's just me, and my health doesn't let me code every day. It's the one in my signature. Trust me, I hate it when people make no effort, too.

What are you even referring to here?

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Some of it I have posted it on my website that is in my signature. Though, there are still dozen of articles I need to write.

 

[Michael Harrop]

Building a website to not only inform people of all kinds of things, but also make a marketplace of stool donors.

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I already did both of those. That's not a solution. It's bizarre that someone would copy what I already did instead of work on needed solutions. It makes it seem like you're not actually interested in solving the problems, and that your intentions are not good.

 

[Aim for NaN]

I already did both of those. That's not a solution. It's bizarre that someone would copy what I already did instead of work on needed solutions. It makes it seem like you're not actually interested in solving the problems, and that your intentions are not good.

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The problem is you stopped doing that. I will not wait for congress to get their act together for me to be healed. Once I'm healed, then will I be fit for travel and fighting the government on the issue. Access to stools comes first. I'm not willing to suffer at the hands of the healthy.

 

[Michael Harrop]

The problem is you stopped doing that. I will not wait for congress to get their act together for me to be healed. Once I'm healed, then will I be fit for travel and fighting the government on the issue.

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I did not stop. The FDA restricted who can purchase stool. IE: stool can only be distributed as part of a clinical trial or under an individual-patient-IND.

And there is no "waiting for Congress". Congress isn't going to do anything unless people make them, and the people who want FMT are not making Congress do anything.

I think anyone who reads the blogs (https://www.humanmicrobes.org/blog) and understands what I did, and what the roadblocks are, will agree that a single person duplicating what I did is not a genuine attempt at obtaining a highly effective donor. Especially so now that the FDA is preventing stool from freely being sold to anyone.

I think the idea that, under these conditions, you could find donors as good or better than the ones I've found, by duplicating what I did, is absurd.

 

[Aim for NaN]

FDA restriction means you stopped. If Congress won't do anything until a large number of people speak up, then we're just waiting for Congress. Duplicating what you did is the only thing that will help RIGHT NOW.

 

[SFBayFMT5]

FDA restriction means you stopped.

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As Michael already said, he did not stop voluntarily, the FDA threatened legal action if he were to continue selling.

You may have a point in that if there were 50 businesses selling FMTs in the US, that might be too many "flies" for the FDA to "swat" and so some would always stay open. However, going to the process of finding a donor pool, testing them, etc. is a lot of work and expense to then 6 months or a year down the road get threatened by the FDA with fines if you don't close down. You can try starting your own but beware of this reality.

If Congress won't do anything until a large number of people speak up, then we're just waiting for Congress.

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There are not enough people who need FMT and know they do to force Congress to do something. I've noticed myself that if I recommend FMT to people in chronic illness groups who I suspect might benefit from it, half of them don't even respond back, and of those that do, most just give a polite acknowledgement for me taking the time to suggest something, but make it clear they're not interested.

Michael seems to have stopped trying to attend meetings in DC, from the fact that he hasn't posted any update videos in months now, but he never actually gave any updates on the forum. I don't know why. But it seemed like the meetings were very difficult to get into. And, one person in a meeting pushing FMT, especially a non-doctor, is unfortunately liable to be labeled as weird or even unhinged unless it's done in a very careful manner.

I wrote to several Congresspeople about it and didn't get even an acknowledgement that my messages were received.

 

[nelson]

As Michael already said, he did not stop voluntarily, the FDA threatened legal action if he were to continue selling.

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Apologies if this has been brought up before, but I'm wondering where the boundary is here?

(1a) You go direct to someone to collect their stool and do FMT
(1b) You have someone ship their stool to you and do FMT.
(2a) You go direct to someone to collect their stool and do FMT, then you pay them $x
(2b) You have someone ship their stool to you and do FMT, then you pay them $x
(3a/b) You ask your friend who he knows that has healthy stool according to his special criteria. Then you go do 2a/2b. You let your friend know how it went.
(4a/4b). Same as 3a/3b, but you pay your "friend" $x as a finder's fee.
(5a/5b). Same as 4a/4b, but your friend shares you his list of experiences of treating diseases or side effects from FMT from those people
6b. You pay your friend to have stool shipped to you from someone he knows, along with instructions on how to use it for FMT, and information on how this can treat diseases

Clearly, 1a is legal. And 6b is illegal. At what point in this process will the FDA start to slap you? What is it specifically that is causing it to be illegal? Is it the shipment? Paying the person for their stool? Paying the "finder's fee"? Is it just the bundled information about treatment of diseases? Bundled information on how to do FMT with the stool? Just wondering if HM or similar operations could simply go down the list, partially decentralizing/decoupling all of the operations, such that there's no specific "company manufacturing a drug"

 

[SFBayFMT5]

I heard (Michael unfortunately never shared the details, if he even knows) that it's when you market stool as a treatment. In other words, it's entirely on the marketing side. So NONE of these is illegal for you. As I understand it, most of them are also legal for the donor and/or the friend, as you approached them seeking the service.

I'm not sure where the line is drawn, going the other way (i.e. the person offering the service advertises that fact to arbitrary potential customers who don't yet exist at the time of the offer). Clearly, having it be for the purpose of treating human disease is necessary--none of these would presumably be illegal if the stool is sold as manure for fertilizing your fields (there may be warnings that are mandated for that, but that's a completely different area of law)--but the question is when it becomes sufficient. It's possible that in some cases it's even sufficient for 1a), depending on how widely the willingness is advertised and if any medical claims are made. By "in some cases" I mean that there's possibly a difference between "There's a group online where people discuss FMT, and someone else in the group said in a private post to that group that he/she was available to donate", vs. "The donor made a website that is visible to the entire world for the purpose of furthering their offering stool". Certainly if the person making the website isn't even the donor him/herself, but someone else taking money and passing it on to the donor, then that goes into much more clearly illegal territory.

In any case, IANAL and all the above paragraph is just speculation based on what I know. Hopefully Michael has been told clear enough information in the legal complaint provided to him (and by any legal counsel he approached for assistance in his response to it) that he could tell us the facts.

 

[Michael Harrop]

The FDA's letter & stance are public: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/human-microbes-672740-02092024. When I met with them, they would not answer additional questions.

I have no additional information since I was unable to find a lawyer who charges a reasonable fee. The only one I found was charging $7500 just for an initial consult.

Yes, you can sell stool for nonmedical purposes, but demand/sales will be extremely low, and you'll never be able to recruit "curative-quality" donors. It would take a ton of time and effort over many years, and you'd never be able to match what I did.