Is human microbes getting shut down? Sources 

Fmt2024

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Michael stated, in his most recent update, That he received a warning letter from the FDA. What does this most likely mean? Are they prohibiting him from selling more FMTs? Are they requiring some sort of protocol?

I am worried for our health, I believe this was our only hope for a while.
 
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From their letter, it sounds like anyone who supplies stool for FMT qualifies as a drug developer, and thus requires an approved IND (investigational new drug) application. I contacted the FDA about applying for an IND back in 2021 and never heard back.

Previously, I wasn't able to find the exact requirements for IND application approval, but I've heard that the requirements are extremely onerous.

I am working on a response to the FDA, and will write up a blog with all the details depending on their response.

"Shut down", no. There is no possibility of HM shutting down due to this. There is the possibility that HM gets drastically changed, and thus becomes unavailable for most people. And there is the possibility of HM shutting down for other reasons.

I just looked up the IND requirements again and there is some interesting information that I'm not sure I want to discuss publicly, but it may be possible for HM to continue operating as is, with some major changes that make things much harder for recipients.

It definitely seems like these requirements were not designed for FMT, and are poorly applicable to it. But it does seem doable if we have a physician who is willing. https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application
 
From their letter, it sounds like anyone who supplies stool for FMT qualifies as a drug developer, and thus requires an approved IND (investigational new drug) application. I contacted the FDA about applying for an IND back in 2021 and never heard back.
Sort of curious to me that you're considered a "supplier" when you're not creating nor shipping a product. Are you complicit no matter what as an organizer, or is there any vector for abstracting the business more to no longer be a 'supplier'?
 
From their letter, it sounds like anyone who supplies stool for FMT qualifies as a drug developer, and thus requires an approved IND (investigational new drug) application. I contacted the FDA about applying for an IND back in 2021 and never heard back.

Previously, I wasn't able to find the exact requirements for IND application approval, but I've heard that the requirements are extremely onerous.

I am working on a response to the FDA, and will write up a blog with all the details depending on their response.

"Shut down", no. There is no possibility of HM shutting down due to this. There is the possibility that HM gets drastically changed, and thus becomes unavailable for most people. And there is the possibility of HM shutting down for other reasons.

I just looked up the IND requirements again and there is some interesting information that I'm not sure I want to discuss publicly, but it may be possible for HM to continue operating as is, with some major changes that make things much harder for recipients.

It definitely seems like these requirements were not designed for FMT, and are poorly applicable to it. But it does seem doable if we have a physician who is willing. https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application
When they say research study i think they mean specific research study. (I.e. Effect of Fmt on people with depression, lymes, C. Diff etc.) recipients would probably also have to come from one state (since physicians usually only have a license to practice in a single state) which would further limit the potential recipients.
 
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Are you complicit no matter what as an organizer, or is there any vector for abstracting the business more to no longer be a 'supplier'?
It seems like I would have to completely change the wording of the website to have no mention that we're providing stool for FMT.

When they say research study i think they mean specific research study.
Firstly, I think we could register as a specific study. Secondly, Openbiome was operating under an IND, so the model is possible.
 
It seems like I would have to completely change the wording of the website to have no mention that we're providing stool for FMT.


Firstly, I think we could register as a specific study. Secondly, Openbiome was operating under an IND, so the model is possible.
Yes you could but it would limit the recipient significantly would make it much harder to find a superdonor there would be a lot les people willing to pay that much for a specific condition.

Interesting, openbiome was only limited to c diff patients though.
 
Interesting, openbiome was only limited to c diff patients though.
They supplied stool to clinical trials for other conditions. An IND should not be limited to C. diff. It is the absence of an IND which limits FMT to C. diff.

I don't understand your first paragraph.
 
They supplied stool to clinical trials for other conditions. An IND should not be limited to C. diff. It is the absence of an IND which limits FMT to C. diff.

I don't understand your first paragraph.
Sorry, ignore that.

Ah I see, would you still be able to sell fmt commercially? Since that is primarily how donors would be able to generate income and would draw more donors to apply
 
Just curious. Where in the world is least inhibited by FDA-like regulations like this?
 
Millions sounds like a ridiculous cost to entry. That sounds like it would be illegal for the FDA to do.

It appears they don't want patients abused in below article based on price. If I'm reading correctly, they want to limit companies from profiting off experimental drugs. Charging a 3m entrance fee would go directly against that for any study that won't be used on millions of people. If you're a not for profit or reinvest all earnings, id think you'd be within your limits here.

https://www.federalregister.gov/documents/2009/08/13/E9-19004/charging-for-investigational-drugs-under-an-investigational-new-drug-application

I can't read the whole article you supplied because I don't want to register, but it appears that $3m is to register a new drug with clinical trials showing its efficacy. You're clearly not at that point. You're in research.
 
From their letter, it sounds like anyone who supplies stool for FMT qualifies as a drug developer, and thus requires an approved IND (investigational new drug) application. I contacted the FDA about applying for an IND back in 2021 and never heard back.

Previously, I wasn't able to find the exact requirements for IND application approval, but I've heard that the requirements are extremely onerous.

I am working on a response to the FDA, and will write up a blog with all the details depending on their response.

"Shut down", no. There is no possibility of HM shutting down due to this. There is the possibility that HM gets drastically changed, and thus becomes unavailable for most people. And there is the possibility of HM shutting down for other reasons.

I just looked up the IND requirements again and there is some interesting information that I'm not sure I want to discuss publicly, but it may be possible for HM to continue operating as is, with some major changes that make things much harder for recipients.

It definitely seems like these requirements were not designed for FMT, and are poorly applicable to it. But it does seem doable if we have a physician who is willing. https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application
Michael stated, in his most recent update, That he received a warning letter from the FDA. What does this most likely mean? Are they prohibiting him from selling more FMTs? Are they requiring some sort of protocol?

I am worried for our health, I believe this was our only hope for a while.
I would be happy to advise on this topic. As you may recall, I am the founder of MyGutly the first personal or autologous fmt service in the United States. I decided to go the auto path due to the IND requirements and the FDA. I spent 15 years running a stem cell company and working with the FDA and filing an IND is huge undertaking 12-15 years and 1 Billion dollars until approval if that. In 2018-2022 there were over 5000 INDs for stem cells and only 16 approvals. Although not exactly the same as FMT it gives an overview of the process and time and money involved.

The auto personal model enables a person to use their own microbiome without an IND.
 
an IND is huge undertaking 12-15 years and 1 Billion dollars until approval if that.
My understanding is that this is for the entire process of getting a new drug approved. In our case, we don't need a new drug to be approved. We only need an active application.

In 2018-2022 there were over 5000 INDs for stem cells and only 16 approvals.
Do you have a citation for this so I can understand it better? I'm guessing it means that the FDA approved the use of stem cells for 16 new applications/conditions? Not that people sent in 5000 IND applications and they were virtually all denied right away.
 
It costs about 100K to file an IND. Yes that is to get market approval which is the end goal of an IND.

Why do you think that having an active IND is enough? Will ever patient be enrolled in the IND?
 
The 100K was from a quote for a consulting agency to do the filing. If you have all of the information ready to go, and don't need more data then it can cost as little as 100K for the filing.
 
Just FYI, Einar Jordan (who says he used to work for the FDA) mentioned that the FDA will leave you alone as long as you don't make any claims about the intended purpose of the product. From what he said about the IND requirements, they'll be completely our of your reach. So I'd assume that simply removing any mention of FMT, although unfortunate, would be the path of least resistance.
 
It is true that I could drastically change the wording on the website to remove all mention of FMT, and that would keep the FDA from getting involved. That would make the website unfindable for most people and it would completely destroy one of the main goals of HumanMicrobes.org -- finding high-quality stool donors for FMT clinical trials and more. It would also make donors much less likely to apply. It would essentially kill the project without completely chopping its head off.
 
It is true that I could drastically change the wording on the website to remove all mention of FMT, and that would keep the FDA from getting involved. That would make the website unfindable for most people and it would completely destroy one of the main goals of HumanMicrobes.org -- finding high-quality stool donors for FMT clinical trials and more. It would also make donors much less likely to apply. It would essentially kill the project without completely chopping its head off.
Hmm I think as donor quality continues to increase, word will spread on social media. I could be wrong but I can’t imagine people are finding your website in many other ways.

Yes, you wouldn’t be able to provide FMT for clinical trials, at least for now, but you would be able to continue your search for high quality donors and to potentially heal yourself and others.

I don’t think donors are applying to donate for the purpose of FMT; rather, I believe they are applying for the financial incentive.
 
I think as donor quality continues to increase, word will spread on social media. I could be wrong but I can’t imagine people are finding your website in many other ways.
Donor quality is not going to increase on its own. I recently posted to social media https://mastodon.social/@michaelharrop/111839584865293858 that I've received over a million applicants at this point and still haven't found one that meets the ideal criteria. Donor applicants are finding us via social media videos. I think most recipients are finding us via keyword searches.

but you would be able to continue your search for high quality donors and to potentially heal yourself and others.

I don’t think donors are applying to donate for the purpose of FMT; rather, I believe they are applying for the financial incentive.
Many people are enticed by the money, but many of them think it's a scam because "no one's going to pay $500 for poop". If all mention and coverage of FMT was removed from the site the legitimacy of it would drastically decrease, as would the number of applicants.

Many of our ideal candidates are very well-off, so the money wouldn't be a motivator for them. There are many people who are motivated by the potential to help others and be the source of a cure/treatment for numerous illnesses. It's also necessary for influential people and organizations to learn about what we're doing because we certainly need their help.
 
Donor quality is not going to increase on its own. I recently posted to social media https://mastodon.social/@michaelharrop/111839584865293858 that I've received over a million applicants at this point and still haven't found one that meets the ideal criteria. Donor applicants are finding us via social media videos. I think most recipients are finding us via keyword searches.


Many people are enticed by the money, but many of them think it's a scam because "no one's going to pay $500 for poop". If all mention and coverage of FMT was removed from the site the legitimacy of it would drastically decrease, as would the number of applicants.

Many of our ideal candidates are very well-off, so the money wouldn't be a motivator for them. There are many people who are motivated by the potential to help others and be the source of a cure/treatment for numerous illnesses. It's also necessary for influential people and organizations to learn about what we're doing because we certainly need their help.

Correct but they are likely learning about your site on various social media groups first then using keyword search. I think once you activate a very effective donor, more word will spread in those social media groups and cause a major influx of customers.

I think there are still ways to be vague enough that you’re not violating any of the FDA’s policies and specific enough so donors recognize that the stool is very valuable.

Also, going the IND route would restrict your ability to find a super donor even more wouldn’t it. Donors wouldn’t have nearly as much potential to make what they do now.
 
Also, going the IND route would restrict your ability to find a super donor even more wouldn’t it. Donors wouldn’t have nearly as much potential to make what they do now.
Why is that?

I think once you activate a very effective donor
I don't think we'll get to that point if we have to remove all mention of FMT from the website.

more word will spread in those social media groups and cause a major influx of customers
I would say that most of the info on social media these days is terrible and untrustworthy. People do not behave rationally and spread useful information. HMorg is already a massive and extremely important project that doesn't get talked about anywhere other than by a group waging a disinformation campaign against it. C. diff patients would already be thronging to use our donors if social media had that ability.
 
Would you still be able to pay them $500 per stool?

I don't think we'll get to that point if we have to remove all mention of FMT from the website.
I can still see a major influx of applications from videos that go viral, like the ones that have in the past. Alot of them don’t mention FMT, just the financial incentive.

I would say that most of the info on social media these days is terrible and untrustworthy. People do not behave rationally and spread useful information. HMorg is already a massive and extremely important project that doesn't get talked about anywhere other than by a group waging a disinformation campaign against it. C. diff patients would already be thronging to use our donors if social media had that ability.
I agree. I am surprised it hasn’t gotten more recognition.
 
Would you still be able to pay them $500 per stool?
From what I read, it's possible but up to FDA discretion.

Alot of them don’t mention FMT, just the financial incentive.
The ones I saw showcase our website, which clearly explains the need and importance of stool donors for FMT. The videos lead them to our website, but it's the FMT content on our website that convinces them it's real and worth signing up for.

The comments on those videos are all FMT-related as well. With nurses, patients, etc. chiming in to comment on the legitimacy and importance.
 
From what I read, it's possible but up to FDA discretion.

The ones I saw showcase our website, which clearly explains the need and importance of stool donors for FMT. The videos lead them to our website, but it's the FMT content on our website that convinces them it's real and worth signing up for.
True but there are other ways to maximize its legitimacy.
 
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I could be wrong but I saw one on a tiktok side hustle page that didn’t mention FMT
As I said, the videos lead them to our website, but it's the FMT content on our website that convinces them it's real and worth signing up for.

Those kinds of side hustle videos don't even seem super useful. They've doubled the number of applicants to over a million now, without resulting in a single new #1 donor. They increase the workload without bringing in high-quality applicants. They do not target our ideal demographic.

if you maximize its legitimacy in other ways.
Feel free to elaborate, maybe in a new thread. I'm highly doubtful it's possible but I'm open to ideas and suggestions.

I think our target candidates need to understand the true potential of their stool -- both the life-saving impacts and societal -- so they understand that we need them; it can't be someone else. The South Park episode, for example, did this very well.

I don’t think that removing FMT decreases incoming applications by a drastic amount
I'm quite sure it would drastically decrease all activity -- both recipients and donors; especially high-quality donors.
 
Those kinds of side hustle videos don't even seem super useful. They've doubled the number of applicants to over a million now, without resulting in a single new #1 donor. They increase the workload without bringing in high-quality applicants. They do not target our ideal demographic.
Who is your ideal demographic?

Feel free to elaborate, maybe in a new thread. I'm highly doubtful it's possible but I'm open to ideas and suggestions.
A lot depends on what you can and cannot explicitly state.

One way is to imply that the stool will be used for FMT without explicitly mentioning it. For example, providing a lot of data about the gut microbiome, its influence on health, and perhaps even mentioning FMTs (iffy).

Consider creating a brief video introducing yourself and the project. Putting your face to the project shows your personal accountability and that you’re putting your reputation on the line.

Another option is to redo your donor testimonials. You could also ask donors questions about the legitimacy of the opportunity and see if they are willing to do video interviews. You can offer a financial incentive if needed.

When explaining the purpose of donated stool, you can clarify that you're not involved in determining its specific use. Mention that recipients may utilize the stool for research, treatment development, or therapeutic purposes (also iffy).

Or

You can state that the stool is not intended for FMT but only for research purposes. Many people will recognize that you are mentioning this because you are not allowed to advertise It’s intended use for FMT.

Include testimonials from recipients without explicitly mentioning FMT. You can also highlight the total number of donations you’ve facilitated so far.

Consider including the South Park video mentioned earlier. You can explain that it's included for comedic purposes since it references FMT.

Outline the process you take to ensure the safety of donated stool, including testing for infectious diseases, verifying donor eligibility, ensuring anonymity, and conducting donor testing. This will show your professionalism.

Highlight the simplicity of the donation process to appeal to people who are skeptical.

This is just me brainstorming there are probably other ideas.

I'm quite sure it would drastically decrease all activity -- both recipients and donors; especially high-quality donors.
Advertising on FMT and other Facebook groups isn’t happening enough yet. There is alot of improvement to be made there. They are your target demographic. I see more about microbioma there, which is terrible. Not your fault obviously but more testimonials there should help.

Off topic but it would be nice to learn more about your experience going through one million donor applications. Perhaps there are adjustments that can be made in your criteria?
 
Who is your ideal demographic?
Top young athletes. People like Mbappe, Haaland, Virgil van Dijk, Mohamed Salah, Giannis Antetokounmpo, Ja Morant, etc.

A lot depends on what you can and cannot explicitly state.
From their letter, it sounds like anyone who supplies stool for FMT qualifies as a drug developer
Pretty much, we can't indicate that we're supplying stool for FMT.

Consider creating a brief video introducing yourself and the project. Putting your face to the project shows your personal accountability and that you’re putting your reputation on the line.
There are already two such videos on the website and YT channel. I would have to completely redo them without mention of FMT.

Mention that recipients may utilize the stool for research, treatment development, or therapeutic purposes
Yeah, that may be passable but I still think it would be very difficult and damaging.

Consider including the South Park video mentioned earlier
Unfortunately, it's not available for public streaming.

Outline the process you take to ensure the safety of donated stool, including testing for infectious diseases, verifying donor eligibility, ensuring anonymity, and conducting donor testing. This will show your professionalism.

Highlight the simplicity of the donation process to appeal to people who are skeptical.
This is already on the site.

I see more about microbioma there, which is terrible.
That is because they control and astroturf the biggest FB group and successfully threatened the admin of the other one with legal action. I also hate FB and wouldn't want to spend time there.

Off topic but it would be nice to learn more about your experience going through one million donor applications. Perhaps there are adjustments that can be made in your criteria?
There are some existing threads on that:
Personally, I'm leaning towards writing up a blog and emailing it to the million+ donor applicants. There are lots of interesting and influential people who have applied. Lots of medical and research personnel. I would like to push for proper regulation of FMT (not under IND). I gave my suggestion for what that would look like here.
 
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Top young athletes. People like Mbappe, Haaland, Virgil van Dijk, Mohamed Salah, Giannis Antetokounmpo, Ja Morant, etc.
Hmm interesting. That's a debate for another day.

Pretty much, we can't indicate that we're supplying stool for FMT.
That’s better than I thought.

There are already two such videos on the website and YT channel. I would have to completely redo them without mention of FMT.
Yes, it would help a lot though. If you do end up going that route.

Yeah, that may be passable but I still think it would be very difficult and damaging.


Unfortunately, it's not available for public streaming.


This is already on the site.


That is because they control and astroturf the biggest FB group and successfully threatened the admin of the other one with legal action. I also hate FB and wouldn't want to spend time there.
Makes sense, they love microbioma there.

There are some existing threads on that:
Personally, I'm leaning towards writing up a blog and emailing it to the million+ donor applicants. There are lots of interesting and influential people who have applied. Lots of medical and research personnel. I would like to push for proper regulation of FMT (not under IND). I gave my suggestion for what that would look like here.
I think that’s a great idea.
 
This Expanded Access program https://www.fda.gov/news-events/expanded-access/expanded-access-information-patients that allows patients to try non-licensed drugs seems like it should make it possible for this project to continue.

The criteria seem a tad burdensome:

How does the expanded access process work?

A licensed physician requests the investigational medical product under the expanded access program for you. If your healthcare is managed by anyone other than a licensed physician, you must find a licensed physician who is willing to do the following:
  • Work with the company to submit, or have the company submit, the necessary paperwork to an IRB and FDA on the expanded access request.
Your licensed physician may or may not have access to an IRB, which is usually connected with a hospital or research institution, but there are independent IRBs as well. Depending on the IRB, you may have to pay for the review.

FDA reviews and determines if the expanded access request may proceed.

Other than that, most of their requirements and recommendations are in line with what I suggested in the recent blog post: https://forum.humanmicrobiome.info/threads/the-fda-and-fmt-regulation-mar-2024-humanmicrobes-org.303/

The main difference and issue seems to be that the existing program requires each patient to apply to an IRB for access. I think the FDA could and should make FMT broadly available under similar guidelines that do not require each patient to apply to an IRB.

Though, under Summary of Expanded Access Request Types (Drugs or Biologics), it says "industry" can submit an "Individual Patient Protocol" or "Treatment Protocol", which might be similar to what I've suggested.

It appears that it's still all under an IND, regardless https://www.fda.gov/news-events/expanded-access/expanded-access-categories-drugs-including-biologics.
 
Hmm it sounds like this would allow the project to continue but would make it tedious for recipients to obtain stool and you would still need an IND which is expensive.

It seems like this biggest hurdle is obtaining the IND. I dont think finding a physician willing to submit an IRB is easy for patients but I think its possible.

As a physician myself, I’d be willing to provide my patients with this treatment but I can only practice in one state.
 
I got a letter back from the FDA today requesting a Zoom meeting. But it doesn't sound like they're interested in anything I have to say, nor are they interested in making any changes to FMT regulation to allow a project like Human Microbes to exist. Their letter only states that we haven't made the required changes to the website and the meeting is only "to discuss your plans to take corrective actions".
 
I got a letter back from the FDA today requesting a Zoom meeting. But it doesn't sound like they're interested in anything I have to say, nor are they interested in making any changes to FMT regulation to allow a project like Human Microbes to exist. Their letter only states that we haven't made the required changes to the website and the meeting is only "to discuss your plans to take corrective actions".
That’s extremely disappointing. I agree that they are wrongly classifying FMT as a drug. I was listening to a podcast interview with Dr. Jason Hawrelak, who is a board member of some FMT group, who said they wrote to the FDA to expand use of FMT for Non C.Diff diseases and they were not interested. His opinion was that they will go the sterilized filtrate route. What do you plan on doing?
 
What do you plan on doing?
I will attend the meeting and see what happens. I'm currently still emailing the 1.2 million donor applicants. I'm about halfway through and so far no one seems to care. So things are not looking good.

If you are able to get in touch with Dr. Jason Hawrelak and let him know about this project and the current difficulty with the FDA that could be useful.

His opinion was that they will go the sterilized filtrate route
This would be a terrible decision by the FDA. There is no way that sterilized filtrate will be as effective as FMT. EDIT: I also do not think that the current evidence supports sterile fecal filtrate as being safer or more effective. There is very little science on sterile fecal filtrates, so it seems strange that they'd already be backing it.
 
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Call me cynical, but given your lack of medical credentials I'm surprised they even responded, let alone offered a meeting. My impression is that because the FDA has an impossible task—permitting only treatments deemed safe (which can only be determined with excessive money and time)—in a lawsuit-happy country, they remain overly conservative to protect themselves, and unless you're one of the giants they won't give you the time of day.

By all means, give them your best pitch. It will at least show you're genuine. But I would just be prepared for a very firm "no" :/
 
given your lack of medical credentials I'm surprised they even responded
This is irrelevant/non sequitur.

Relatedly, I think the only person in the world that comes close to matching my knowledge of FMT is another patient. There is no one in the world I would look to for advice on FMT, but his input can be useful. This reflects the nature and status of FMT. Stool is not a pharmaceutical, and FMT and this project both have vast potential far beyond any drug. So treating it like one, per your comment, would be completely irrational and harmful.

If the FDA were to decline to engage with arguably the most knowledgeable person in the world on this highly experimental treatment, it would be absolutely absurd and idiotic, unless they had an agenda to suppress a likely cure for most chronic diseases. Hopefully they don't.

Moreover, it is their standard operating procedure to issue a warning, then do an inspection, and then follow up as necessary.

Your comment also makes me doubt that you read the two most recent blog posts about this https://www.humanmicrobes.org/blog. Because they describe how this:
the FDA has an impossible task—permitting only treatments deemed safe
is not possible for FMT without the Human Microbes project.

They also describe the severe consequences of this:
I would just be prepared for a very firm "no"
Which your comment doesn't seem to recognize, and which includes the extreme cruelty to us patients of holding back FMT "until it can be proven safe".

I would assume, and hope, that people working for the FDA have enough intelligence and empathy to understand all this.

BTW, as previously mentioned, there is no such thing as a "no". It's only a matter of how much more difficult they will make things for us.
 
FDA Enforcement Discretion and EUAs (Emergency Use Authorization):
What Is Enforcement Discretion?
As an agency responsible for ensuring public health and safety, if the FDA believes a product risk is low or could have a significant benefit to the public, it will exercise enforcement discretion on certain requirements allowing a company to bypass its typical regulatory pathway.
“Both enforcement discretions and emergency use authorizations make it possible for a manufacturer to sell their product outside the traditional regulatory environment. The emergency use authorization applies in a public health emergency, where the enforcement discretion could apply to something that is considered low risk to patients, but there is still a medical need,”
FDA enforcement discretion policies allow companies to deliver innovative products quicker to the public and help address unmet medical needs without undergoing the traditional approval process, which is extensive and can take decades.
FDA has the authority to issue EUAs, which allowunapproved medical products or unapproved uses of approved medical products to be used in an emergency” when there are no “adequate, approved, and available alternatives.”
FMT, and the patient need for it, very obviously meets this description.

It seems that the FDA could very easily extend enforcement discretion for FMT to cover sources of stool donors that are publicly tracking & reporting results, in addition to the other suggestions I listed in the blog. This seems like a very simple and reasonable action.
 
If you are able to get in touch with Dr. Jason Hawrelak and let him know about this project and the current difficulty with the FDA that could be useful.
I can absolutely reach out!
This would be a terrible decision by the FDA. There is no way that sterilized filtrate will be as effective as FMT.
If the FDA were to decline to engage with arguably the most knowledgeable person in the world on this highly experimental treatment, it would be absolutely absurd and idiotic, unless they had an agenda to suppress a likely cure for most chronic diseases. Hopefully they don't.
I think that’s possible. I can see the FDA being influenced by drug companies who might prefer sterile fecal infiltrates geared towards treating specific conditions. It would likely be more profitable but, I agree, not nearly as effective as FMT.
 
I'm no fan of the FDA and how they've treated FMT, nor am I suggesting it makes sense to only allow MDs to do what you're doing. I'm just pointing out that they're a big organization with specific rules/processes, and just because they should approach a unique case differently doesn't mean they will, regardless of how cruel that would be. I wouldn't even think they would need an agenda or ulterior motive—just old fashioned bureaucracy.

I would be genuinely delighted to learn that I'm wrong. I just don't want you to be caught off guard if you end up feeling like you're dealing with the DMV when you speak to them.
 
I will attend the meeting and see what happens. I'm currently still emailing the 1.2 million donor applicants. I'm about halfway through and so far no one seems to care. So things are not looking good.

If you are able to get in touch with Dr. Jason Hawrelak and let him know about this project and the current difficulty with the FDA that could be useful.


This would be a terrible decision by the FDA. There is no way that sterilized filtrate will be as effective as FMT. EDIT: I also do not think that the current evidence supports sterile fecal filtrate as being safer or more effective. There is very little science on sterile fecal filtrates, so it seems strange that they'd already be backing it.
Firstly I'd like to say I'm one of the 1.2 million applicants that was excluded by your screening process and I still took the time to join this conversion and give some feedback and ideas with no benefit or gain to myself. So it's not entirely true that no one cares.

I've actually witnessed you make several assumptions like this about a few things I've read here and in your emails and blog posts. I'll try to give some constructive feedback on solutions here since I know you are overwhelmed as it is.

1) Communication: Emailing 1.2 million applicant is no a complicated thing with the right tools, like a proper mailer/list manager, SMTP service, segmented list. You could literally write your email as if you were mailing one person , click a few buttons and the software would reliably take care of the rest for you. Additionally if you required emailing different segments this effort would also be reduced and made much easier to process in batches. It seems to me although you are brilliant at FMT research you could be more open minded and efficient at technology application and processing your data , or hire someone that is. Outsourcing doesn't have to be expensive if you have a system that someone can follow and the tools to do it. All successful organizations do this.

2) Targeting: I agree that you need to better target highly probable groups that could become "ideal" donor prospects, but you have said yourself that your algorithm doesn't produce the result you are after even when it is a young healthy athlete.

so I think that's a pretty good sample size to conclude that your current vetting method could be missing something. Although I'm sure you feel your criteria is valid you are really just guessing because unless you actually test each applicants stool you could be missing that ideal person you are looking for with the X factor.

You have also stated yourself that the young athlete category isn't always producing a good result and some have perplexingly bad stools for such great physiques. You need to expand your criteria to potentially include someone that cares about their health and their stool.

Athletes although fit aren't necessarily healthy. Many fitness protocols are very unhealthy. This is often very true in young people with the rising interest in exogenous hormone and other molecular usage , intense fitness routines that are nothing more than over training etc. Being young with a good physique don't make you smart. Many people as such use short cuts and creating to achieve their results.

Have you considered the the rising interest in the longevity and anti aging group? There are several young people in great shape in this group and they are already having their stools tested on their own to measure their microbiome health. And also perhaps some older people who have consciously cultivated their microbiome. I'm no expert on FMT or what you need but it seems to me your filtering is too exclusionary before you get actual proof (lab tests stools). I also realize this is partly due to sheer volume of applicants and of course targeting. But why not cast a wide web if you're already looking for a needle in hay stack and you can structure it so that the needle might make itself stand rather than needing to look at ever piece of hay to uncover it your self.

Solution A: Target people already monitoring their microbiome on their own dime. Longevity , Healthspan, Anti aging crowds.

Solution B: Why not take advantage of the 1.2 million applicants you already have by offering those you disqualified the opportunity to prove their stool is good by having a lab they can send their stool too for testing if they are willing to pay for their own test. You could have AI go over the lab results and organize them, so you,re not wasting time on clearly disqualified delusional people and you still get to learn from the process and possibly capturing more provable data on your applicant pool. You might also discover what criteria your algorithm is missing.

I can say that I for one would have been willing to pay for these tests just to discover how healthy or unhealthy my own microbiome is even if I didn't get the opportunity to make $500 per stool. That the selling point to gt people to do it if they really want the opportunity. You can simple say "I'm sorry but according to our initial screening you did not qualify but if you feel the was a mistake and would like the opportunity to prove you are a good candidate and would like to find out the actual health of your microbiome. Pay XX$ to get your stool tested here {link}, receive a microbiome health report and we will both know for sure. Im sure you can arrange something with one of these companies already doing this testing and reporting and s up an easy way to filter the actual data to have a second look.


I came to this forum and to apply and know about you and your work thru one of those side hustle videos. You never know who will see things or how they will come to you. I do agree although it's not the ideal group for targeting but it did generate this feedback for you so it does have some potential value.

3) Your website and FMT mention: This really is being over valued. The term FMT itself had no bearing on my application. The $500 for healthy stool was the primary motivator and the secondary motivator was that it was being used to help people generally who didn't have a healthy microbiome. Whether that's research or providing the stool for treatment didn't really matter.

I think you can easily remove the FMT information wording, state things very generally and still get applications. You could even say due to FDA rules you can't state specifically what the stool will be used for but that it is going to research to help people with an unhealthy microbiome. Regardless this is just my personal opinion but it is true that once again you have no actual data that you won't get applications or that mentioning FMT is important in people completing applications.

Like I said you can word things generally and still attract people that care and want to help. That is in fact one of your most important criteria. The only people that care about FMT specifically and the term itself are the recipients and researchers like yourself. I personally didn't even know about FMT before this and I'll bet that your ideal donor doesn't either and that expecting them search for it is completely unrealistic.

My intention in writing this 8000 character post and the time it took out of my day to do so is too open a good human beings mind a little more to the possibilities of the solutions to their issues. Anyone can relate to being caught up in the middle of it, when you're in it. I am not and insider in the area so Im giving you an outsiders view of what I see. Sometimes that is what is needed.

You clearly communicate your problems but perhaps unknowingly you also communicate why you have them. It's wonderful that there are people like you that care so much in this world that they dedicate their life and work to helping others suffering. Keep up the good work and I wish you the best and I hope you take my comments for what ever value you can find in them. At the very least I hope it sparks a possibility with in you towards a solution. There are alway people that care. Don't ever lose hope. In the end that's all good people can hold on to, and thank God you provide that for the people suffering from this condition.

Sincerely,
Joseph
 
Hey Joseph, thanks for applying and giving us your input!

I think metagenomic sequencing is promising but we don’t yet know what microbial profiles make someone a super-donor or effective for treating certain conditions as far as I know. Although, I have come across a few studies finding success with donor matching for UC.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9927247/

I think a possible alternative approach would be trialing FMT from donors who fit a slightly different criteria but that comes with its own risks and there would need to be recipients who are willing to try.

It's wonderful that there are people like you that care so much in this world that they dedicate their life and work to helping others suffering.
Yeah he doesn’t get enough credit for this.
 
As far as I can tell, the FDA is investigating me as if I'm a criminal due to the fact that I've been breaking the law by distributing an unapproved drug. And they don't give a shit about the vast majority of what I've told them, because it's irrelevant to whether or not I'm committing a crime.

I can't read the FDA's mind. I don't know if they're supportive and want high-quality donors available for themselves and their loved ones, or if they're viciously trying to shut me down. The safest thing to do is to assume they want to shut me down, so that's what I'll assume until there is evidence to the contrary.

I have not been able to find a lawyer who can advise me, and I cannot afford lawyers who are charging $500/hr. Most likely, any lawyer would quote me multiple hours to review everything and give me advice.

I have made changes to the website on my own, but I don't know if it's adequate. The FDA does not respond to questions; only a lawyer can.

So far, their answer to "Do you really want us to switch to selling poop for recreational purposes, and stop all tracking & reporting of results? Who does that benefit?" seems to be "yes".
 
I don't know if they're supportive and want high-quality donors available for themselves and their loved ones, or if they're viciously trying to shut me down.
I think it’s the more towards latter.

I have made changes to the website on my own, but I don't know if it's adequate.
I think this is good start.

Horrible news that they won’t let this project continue as is. I would get a lawyer ASAP, one that has experience with the FDA. Maybe we can try starting a GoFundMe for lawyer fees?
 
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