Michael Harrop
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Blog The FDA and FMT regulation, part 2. (Jul 2024, HumanMicrobes.org) I met with the FDA. Here's what I shared with them, and their response.
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AmberAustin
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I wonder if creating a mini documentary for YouTube with success patient stories and maybe some donors (if they are willing to not be anonymous). Seems that may help further increase visibility and support? I'm not sure just trying to offer some supportive ideas to help with this fight.
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Michael Harrop
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That's an interesting idea. It could be helpful. The downsides I see are that it would take up a good amount of my time (which is still mostly dedicated to screening huge amounts of donor applications pouring in), and making videos like that is definitely not my expertise, and most donors & recipients want to remain anonymous.
My suggestions would be for people to contact news organizations, legislators, and regulatory agencies. You can share the blogs with them. I think most of them would agree that if no entity is going to work to provide this simple treatment for us, we should be allowed to work to acquire it ourselves.
My suggestions would be for people to contact news organizations, legislators, and regulatory agencies. You can share the blogs with them. I think most of them would agree that if no entity is going to work to provide this simple treatment for us, we should be allowed to work to acquire it ourselves.
Two things:
1."Most of our donors will remain available at the current price, but not for the purpose of FMT". I
read both blogs but didn't see the info I was looking for on this -- what are they available for now?
I saw the potential avenue of human-fermented food, but that seems like a future avenue and also not
viable for all countries?
2. While I appreciate these blog posts, I do not think they are ideal for sending out to politicians, etc.
Any literature to be blasted en masse should be extremely concise, free of any complaints, lamentations
or digressions.
Something like:
-Intro to concept of the importance of the microbiome (cite a couple sources)
-Intro to FMT as solution (cite a couple sources)
-Success of humanmicrobes project
-Problem (FDA) and specific call to action (recategorization for this specific case)
In its entirety, this should be less than a page. If the reader has to scroll or read through a digression or even a relevant anecdote too granular for their frame of reference, your chances of them getting through it or caring falls drastically (particularly true of politicians, legislators and organizers who are inundated with this type of thing constantly, and the writers always sound no less urgent).
1."Most of our donors will remain available at the current price, but not for the purpose of FMT". I
read both blogs but didn't see the info I was looking for on this -- what are they available for now?
I saw the potential avenue of human-fermented food, but that seems like a future avenue and also not
viable for all countries?
2. While I appreciate these blog posts, I do not think they are ideal for sending out to politicians, etc.
Any literature to be blasted en masse should be extremely concise, free of any complaints, lamentations
or digressions.
Something like:
-Intro to concept of the importance of the microbiome (cite a couple sources)
-Intro to FMT as solution (cite a couple sources)
-Success of humanmicrobes project
-Problem (FDA) and specific call to action (recategorization for this specific case)
In its entirety, this should be less than a page. If the reader has to scroll or read through a digression or even a relevant anecdote too granular for their frame of reference, your chances of them getting through it or caring falls drastically (particularly true of politicians, legislators and organizers who are inundated with this type of thing constantly, and the writers always sound no less urgent).
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Michael Harrop
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Anything other than "for the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animal".
I have no idea how viable the fermented food avenue is, nor in what countries. Even though the supplement market is largely unregulated, I think there are still GMP requirements. I haven't looked into it because I think it's very far from ideal and should be a last resort.
My brain function is quite poor. Do you think you're capable of writing such a summary?
Got it, thanks!
Yes. I will take a stab at this when I have a free moment. I'll send it your way when I'm done.
Below I have listed people/organizations we can contact to help raise awareness. I encourage anyone reading this to reach out to as many of these people/organizations as possible providing your own personal experience with HM/FMT, the current dilemma HM is in, provide them with links to the blog posts, etc. I plan on writing to the people/organizations listed below but please let me know if there are any other contacts I should add to this list.
News organizations
New York times
- https://www.nytimes.com/2019/10/15/homepage/contact-newsroom.html
Washington post
-https://helpcenter.washingtonpost.com/hc/en-us/articles/236004788-Send-a-letter-to-the-editor
The Gaurdian
- "Editorial department and desk
Opinion desk: [email protected]"
- If this is the wrong contact then they can direct us to the correct one.
BBC
- "If you have any questions you'd like to ask BBC News teams, you can get in touch by emailing [email protected] or using the hashtag #BBCYourQuestions on X (formerly known as Twitter.)"
NPR
- Https://help.npr.org/contact/s/contact?request=Send-a-story-idea&show=Consider This from NPR
Legislators
Congressman
- You can reach out to each of your state's representatives
Regulatory agencies
FDA
Some information on patient listening sessions:
- "Are about patient experiences, perspectives, and needs related to their health or a disease, and not about specific medical products (drug, biologic, or device)". So maybe not super helpful but we could bring up the benefit FMT has had.
- "Patient Listening Sessions can either be FDA-requested (where FDA has a specific set of questions to ask) or patient-led (when a patient community wants to share their perspectives with the FDA)." More information in article.
- Https://www.fda.gov/patients/learn-about-fda-patient-engagement/fda-patient-listening-sessions.
Influencers
Health/microbiome influencers on social media:
- Dr. Andrew Huberman, Podcaster
- Dr. Will bulsewicz, author of Fiber Fueled
- Dr. Michael Gregor, Author of "How Not to Die" and owner of nutritionalfacts.org
Physicians on Twitter
- Sabin Hazan - physician that does microbiome research
- Kriben Govender; host of “ got health gurus” podcast
- Kristie Leong - physician health influencer on twitter
Groups you can post on:
- Fecal Microbiota Transplantation (FMT) group
- Fecal transplant Support and Research group
Groups you can post on:
- https://www.reddit.com/r/cfs/
- https://www.reddit.com/r/SIBO/
- https://www.reddit.com/r/IBS/
- https://www.reddit.com/r/COVIDlonghaulers/
- https://www.reddit.com/r/Biohackers/
- https://www.reddit.com/r/Ulcerativecolitis/
- https://www.reddit.com/r/IBSresearch/
- https://www.reddit.com/r/Histamineintolerance
- https://www.reddit.com/r/MCAS
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Michael Harrop
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Federal too! https://forum.humanmicrobiome.info/threads/the-fda-and-fmt-regulation-mar-2024-humanmicrobes-org.303/post-1202
Also, you guys are more than welcome to contact podcasts and go on podcasts yourselves, but don't volunteer me, as my health is too poor for that right now.
The older threads containing my previous letters to the FDA have the email addresses I used: https://forum.humanmicrobiome.info/threads/another-letter-to-the-nih-and-fda-cancer-patients-as-fmt-donors-if-you.59/
You can also contact other regulatory agencies like Health Canada. Health Products and Food Branch, biologics https://www.canada.ca/en/health-canada/corporate/about-health-canada/branches-agencies/health-products-food-branch/biologic-radiopharmaceutical-drugs-directorate.html#Contact.
To anyone who plans to contact entities or post on social media:
It's important that you have read the blogs and understand the issues so that you can provide accurate answers to questions, correct people when they make incorrect statements, and accurately describe what the problems are and why the solution is what you're suggesting.
Letters:
Someone sent me a proposed letter to a regulatory agency where they outlined that FMT was promising for other conditions, so please approve it. I don't think those kinds of generic letters would be useful at all. They're not going to all of a sudden approve FMT because they get a handful of letters asking them to. You need to present a convincing argument/reason for them to change their current stance. You're probably better off explaining your personal situation, and why you think FMT is the best or only option for you. And if you think Human Microbes is the best source, then you should explain why.
Reddit:
For posting to reddit, you should probably not post to a bunch of subreddits at one time. And you should check if someone else has already made a post about it. I think you'll have trouble gaining traction on most of those reddit subs anyway. There are not a lot of well-informed, intelligent, and motivated people on those subreddits. Most people there are constantly inundated with misinformation, so you're fighting an uphill battle.
News outlets:
It's probably a good idea to contact news outlets that tend to cover unusual things, such as VICE and Buzzfeed. I didn't contact either of those two though since I read that one or more of them was closing down.
Yeah, a quick search shows that VICE is shutting down; as is BuzzFeed News. There may be other similar outlets though. For example, an article says HuffPost is taking on some VICE staff. https://www.huffpost.com/static/contact-us
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Michael Harrop
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I just posted a list of how FMT is regulated in other countries around the world: https://forum.humanmicrobiome.info/threads/the-fda-and-fmt-regulation-mar-2024-humanmicrobes-org.303/post-1367
It is very useful; especially the arguments submitted to the Australian regulatory authority. Many of the positions of those groups align quite well with what I've suggested, and with what Human Microbes already does. I think the majority of those groups would agree with allowing access to our donors, as is, if they knew we existed and read the recent blog posts.
Longer list of media to contact:
It is very useful; especially the arguments submitted to the Australian regulatory authority. Many of the positions of those groups align quite well with what I've suggested, and with what Human Microbes already does. I think the majority of those groups would agree with allowing access to our donors, as is, if they knew we existed and read the recent blog posts.
Longer list of media to contact:
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Michael Harrop
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Since @DungEater hasn't responded I took a shot at it. I think I successfully condensed it down into some bullet points:
Title: The FDA, FMT (fecal microbiota transplant), right to try
The full details are in these blogs: https://www.humanmicrobes.org/blog
Especially these two:
The summary is that the FDA is preventing patients from being able to access a treatment, and likely cure, for many diseases because they are classifying poop as an unapproved drug. None of the existing Right To Try laws cover this scenario. There is no monetary incentive for any pharmaceutical company to make FMT available from high-quality (safe and effective) donors. So a patient had to take things into their own hands, and now the FDA is shutting them down. High-quality donors will never be available any other way.
Here are the key points.
Letter to legislators:
Title: The FDA, FMT (fecal microbiota transplant), right to try
The full details are in these blogs: https://www.humanmicrobes.org/blog
Especially these two:
- FDA and FMT part 1 https://www.humanmicrobes.org/blog/fda-fmt-regulation
- FDA and FMT part 2 https://www.humanmicrobes.org/blog/the-fda-and-fmt-regulation-part-2
The summary is that the FDA is preventing patients from being able to access a treatment, and likely cure, for many diseases because they are classifying poop as an unapproved drug. None of the existing Right To Try laws cover this scenario. There is no monetary incentive for any pharmaceutical company to make FMT available from high-quality (safe and effective) donors. So a patient had to take things into their own hands, and now the FDA is shutting them down. High-quality donors will never be available any other way.
Here are the key points.
- The gut microbiome influences every aspect of human health and development. https://humanmicrobiome.info/intro/
- FMT (fecal microbiota transplant) is the most studied and promising intervention to correct "gut dysbiosis", and thus treat, and potentially cure, numerous diseases. It transfers the beneficial microbes from a healthy person to a sick person. https://humanmicrobiome.info/fmt/
- People healthy enough to be highly safe & effective donors are very rare. https://forum.humanmicrobiome.info/threads/while-antibiotic-resistance-gets-all-the-attention-the-damage-being-do.50/
- No single "official source" (clinical trial, doctor, hospital, etc.) has the resources or motivation to acquire high-quality donors, so they've all been using dangerous and ineffective donors.
- A patient analyzed the situation and took it into their own hands to work to find high-quality donors. They've now screened over 1.2 million people worldwide.
- The FDA is essentially shutting them down because the FDA classifies them as a drug manufacturer.
- This classification also prevents people in other countries from accessing their stool donors, even if the other country has not classified FMT as a drug.
- There is no FMT-specific regulation in the USA.
- The FDA is not preventing anyone from accessing this "drug". They are only preventing people from accessing safe and effective donors. FMT is already widely available from dangerous and ineffective donors. It is practiced as a sexual activity ("eating ass"), as coprophagia, and by people DIYing a "medical procedure" with whatever friend or family they can find who is willing.
- If the FDA wanted to make FMT safer, they would allow access to high-quality donors, along with other restrictions/requirements, such as requiring medical supervision, and public tracking & reporting of results to ensure informed consent.
- Other countries have declared that poop is not a drug and should not be regulated as one. https://forum.humanmicrobiome.info/threads/the-fda-and-fmt-regulation-mar-2024-humanmicrobes-org.303/post-1367
- In Australia, the regulatory authority gathered feedback from the public prior to making their regulations. You can read that many professionals in the field opposed regulating FMT as a drug, or even as a biologic. They opposed GMP (good manufacturing practices) requirements because they are far too onerous. They rightfully argued that excessive regulation of FMT will only make things more dangerous.
- A highly respected science journal published an article https://www.nature.com/articles/d41586-024-02212-z titled "Faecal transplants can treat some cancers — but probably won’t ever be widely used". The reasons included “difficulties recruiting donors, demanding screening requirements”. The Human Microbes project has solved this issue, and the FDA is unsolving it.
- The FDA has approved other drugs that are inherently harmful, and many of us patients are now needing FMT to reverse the damage those drugs did.
- Hundreds of millions of dollars are being wasted by being poured into "general research" via the established research system. This system is incredibly incompetent and does not contain individuals/institutions that are able and willing to take on big ideas and unique & innovative projects. FMT requires a very specific approach (https://maximiliankohler.blogspot.com/2019/12/fmt-roadmap-proposal.html) that no one in the research system has been able/willing to take on.
- As a disabled patient, with zero funding, I've already made more progress than hundreds of researchers across the globe have for the past 20-30 years, despite their support networks and funding. They continue to run useless clinical trials with low-quality donors and do not do anything innovative, such as the vital steps in the roadmap proposal.
- Even if the FDA approves the Human Microbes project, funding and partnerships will be required to run clinical trials for Step #3 in the FMT roadmap.
- The amount of attention and funding this is getting is ridiculously disproportionate to the cost of the conditions it's likely to treat.
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Michael Harrop
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The FDA responded to my follow-up, but they did not answer my questions. They referred me to the pre-IND consult process, and I initiated it to find out exactly what the requirements will be. It appears that they are sticking to their guns of keeping FMT regulated as an unapproved drug and requiring GMP standards, so we will have to run clinical trials to get it approved. We will likely need 1 physician, a few thousand patients with the same condition, and funding to pay the physician and donor(s). A trivial amount of money compared to what's being spent on other research, but it's not money I have.
I think the FDA needs to drop the GMP requirement no matter what. Then, if they're unwilling to create FMT-specific regulation that allows this project to continue, we will need funding for a clinical trial.
https://www.sciencedirect.com/science/article/pii/S2452302X1600036X
Elaborating on the points above with supporting evidence. On my personal blog, there are also multiple posts about this.
No reasonably intelligent person would do a study like that if they were genuinely trying to find a cure. You could say "They're ignorant", but a sufficiently motivated person would strive harder to become well-informed before running a trial like that.
Here's another one that even failed for C. diff:
VA trial using the University of Minnesota's donors finds no reduction in C. diff recurrence after FMT (Sep 2024, n=153, UMN)
And another halted for futility:
Rigorous Donor Selection for Fecal Microbiota Transplantation in Active Ulcerative Colitis: Key Lessons From a Randomized Controlled Trial Halted for Futility (May 2024, n=72)
You couldn't blame anyone for thinking it's being done on purpose to ensure that a cure is never available, and billions of dollars continue to get made from selling drugs to sick people. But as the saying goes, never attribute to malice what can be explained by incompetence.
A single disabled patient with zero funding should not be out-performing the entire world's research system. Regardless of what happens with this situation, there needs to be massive changes to our research systems. It seems clear that there is a lack of performance-based incentives. Patients should not have to obtain and develop their own treatments and run their own clinical trials.
Here's an example of the high costs and deficient nature of using blood & stool testing as a primary screening tool: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0276323 - more than 61% of their applicants failed the tests.
None of Human Microbes' donors have failed a blood or stool test because those tests are not our main screening tool, they are simply the cherry on top. Those tests are not an appropriate "primary tool" for screening donors, as the links above demonstrate.
Virtually all other sources of FMT use these tests as a primary screening tool because they do not have better tools, and haven't bothered to acquire or test better tools. I developed a better set of tools. So our donor applicants who make it to the blood & stool testing portion are extremely unlikely to fail those tests.
I'm currently testing a very good donor and while they've been very helpful in many ways, they do not appear to be "a cure", so I think it's time to focus on Step #3: https://maximiliankohler.blogspot.com/2019/12/fmt-roadmap-proposal.html. That requires funding and partnership with research groups.
Let's say FMT, or one source of FMT, gets approved after a clinical trial. I think it's still erroneous to regulate FMT as a drug at that point. Each donor and recipient are so unique; there's an inherent level of unpredictability. And that should be ok as long as recipients are informed about this, able to review donor-specific results from other patients, and have adequate information to judge donor quality, risks, etc. FMT is experimental and will likely remain experimental for many decades. Regulation should account for that instead of prohibiting FMT due to it.
The most recent donor I used is a perfect example of this. I've done countless FMTs from 16+ donors. I arguably have the most practical knowledge and experience with FMT out of anyone in the world, yet this donor had unique, unusual, and unpredictable impacts. I have little idea what would happen if other people used this donor. The only valid approach is to publicly track the results of this donor to see how other people fare, and then let people decide for themselves if the risk-to-reward ratio is worth it for them.
Let's say that for the clinical trial I pick the donor that I think is the #1 rank. That donor may not be the best for everyone/every condition. Some people may benefit more from another donor. The best donors are also going to be a limited supply. People should have the option to choose other donors, and there needs to be informed consent (public tracking of results).
I think a decent comparison is food/diet https://humanmicrobiome.info/diet/. Watermelon and avocados are good, but you shouldn't force everyone to only eat watermelon and avocados.
I think the main goal of any clinical trial should be to verify that my donor criteria are valid for safety, and my top donors are effective enough to be worth any risks.
I think the FDA needs to drop the GMP requirement no matter what. Then, if they're unwilling to create FMT-specific regulation that allows this project to continue, we will need funding for a clinical trial.
https://www.sciencedirect.com/science/article/pii/S2452302X1600036X
The incompetence of the research system:
Elaborating on the points above with supporting evidence. On my personal blog, there are also multiple posts about this.
- They act like robots that have been programmed to perform a very narrow set of tasks. There is a complete lack of innovative thinking, initiative, and ability to think outside the box.
- They continue to do the same thing over and over despite extremely poor results. I don't think they're expecting to get different results from doing the same thing. I think they're happy to just keep doing the bare minimum to get paid, and there appears to be no incentive for them to actually solve the problem.
- Lack of motivation. Anyone can do FMT outside of clinical trials. So if someone was motivated to learn about FMT and run an effective clinical trial they would look for information outside clinical trials. Not only have they not done that, but they've ignored answers that I went out of my way to discover and hand deliver to them.
No reasonably intelligent person would do a study like that if they were genuinely trying to find a cure. You could say "They're ignorant", but a sufficiently motivated person would strive harder to become well-informed before running a trial like that.
Here's another one that even failed for C. diff:
VA trial using the University of Minnesota's donors finds no reduction in C. diff recurrence after FMT (Sep 2024, n=153, UMN)
And another halted for futility:
Rigorous Donor Selection for Fecal Microbiota Transplantation in Active Ulcerative Colitis: Key Lessons From a Randomized Controlled Trial Halted for Futility (May 2024, n=72)
You couldn't blame anyone for thinking it's being done on purpose to ensure that a cure is never available, and billions of dollars continue to get made from selling drugs to sick people. But as the saying goes, never attribute to malice what can be explained by incompetence.
A single disabled patient with zero funding should not be out-performing the entire world's research system. Regardless of what happens with this situation, there needs to be massive changes to our research systems. It seems clear that there is a lack of performance-based incentives. Patients should not have to obtain and develop their own treatments and run their own clinical trials.
Here's an example of the high costs and deficient nature of using blood & stool testing as a primary screening tool: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0276323 - more than 61% of their applicants failed the tests.
None of Human Microbes' donors have failed a blood or stool test because those tests are not our main screening tool, they are simply the cherry on top. Those tests are not an appropriate "primary tool" for screening donors, as the links above demonstrate.
Virtually all other sources of FMT use these tests as a primary screening tool because they do not have better tools, and haven't bothered to acquire or test better tools. I developed a better set of tools. So our donor applicants who make it to the blood & stool testing portion are extremely unlikely to fail those tests.
I'm currently testing a very good donor and while they've been very helpful in many ways, they do not appear to be "a cure", so I think it's time to focus on Step #3: https://maximiliankohler.blogspot.com/2019/12/fmt-roadmap-proposal.html. That requires funding and partnership with research groups.
The experimental nature of FMT:
Let's say FMT, or one source of FMT, gets approved after a clinical trial. I think it's still erroneous to regulate FMT as a drug at that point. Each donor and recipient are so unique; there's an inherent level of unpredictability. And that should be ok as long as recipients are informed about this, able to review donor-specific results from other patients, and have adequate information to judge donor quality, risks, etc. FMT is experimental and will likely remain experimental for many decades. Regulation should account for that instead of prohibiting FMT due to it.
The most recent donor I used is a perfect example of this. I've done countless FMTs from 16+ donors. I arguably have the most practical knowledge and experience with FMT out of anyone in the world, yet this donor had unique, unusual, and unpredictable impacts. I have little idea what would happen if other people used this donor. The only valid approach is to publicly track the results of this donor to see how other people fare, and then let people decide for themselves if the risk-to-reward ratio is worth it for them.
Let's say that for the clinical trial I pick the donor that I think is the #1 rank. That donor may not be the best for everyone/every condition. Some people may benefit more from another donor. The best donors are also going to be a limited supply. People should have the option to choose other donors, and there needs to be informed consent (public tracking of results).
I think a decent comparison is food/diet https://humanmicrobiome.info/diet/. Watermelon and avocados are good, but you shouldn't force everyone to only eat watermelon and avocados.
I think the main goal of any clinical trial should be to verify that my donor criteria are valid for safety, and my top donors are effective enough to be worth any risks.
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AmberAustin
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Maybe a podcast and get like a masters journalism student to do it as a project. It is easier to remain anonymous when only using your voice?
You've probably done this already but contacting researchers who are already doing FMT research for specific conditions (like I know one of the derms I saw did FMT to cure alopecia areata) already. One of my mentor's his wife does microbiome research so I could ask him of he knows anyone else currently doing FMT research. Since you have screened the donors already it would just be a follow-on study seeing if donors based on a different selection criteria improve results.
Also, I can do a lit review for FMT to see what has come out in the last 2 yrs and see if the researchers are still actively looking into it.
The last option too is find a biomedical research company who may be up for doing the FMT experiment.
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Michael Harrop
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I think the solutions are going to come from contacting legislators and entities that fund research.
Even if we get funding, the FDA needs to create unique, FMT-specific regulations that allow a project like this to exist. Simply getting FMT approved and treated like any other drug is not adequate. I covered "why" previously in this thread and the blogs.
Given that the FDA doesn't appear to be willing to budge on this issue, it's up to federal legislators to address the regulatory restrictions and enable the unique clinical trials that FMT requires: a very specific focus on donor quality and clearing the existing microbiome.
There is a related $1 billion COVID moonshot proposal, but it pours the funding into the same system that has been wasting millions of dollars on useless clinical trials with low-quality donors, and which is unable to take on a project like this.
Everyone should write to the COVID Moonshot email address about this. I have written to them, as well as my own federal reps.
Even if we get funding, the FDA needs to create unique, FMT-specific regulations that allow a project like this to exist. Simply getting FMT approved and treated like any other drug is not adequate. I covered "why" previously in this thread and the blogs.
Given that the FDA doesn't appear to be willing to budge on this issue, it's up to federal legislators to address the regulatory restrictions and enable the unique clinical trials that FMT requires: a very specific focus on donor quality and clearing the existing microbiome.
There is a related $1 billion COVID moonshot proposal, but it pours the funding into the same system that has been wasting millions of dollars on useless clinical trials with low-quality donors, and which is unable to take on a project like this.
Everyone should write to the COVID Moonshot email address about this. I have written to them, as well as my own federal reps.
Specifically, we need:
- Funding and partnerships to run one or more clinical trials with Human Microbes' top donors to compare their safety and efficacy to the average donor being used worldwide.
- Funding and partnerships to run animal and human studies on methods to clear the existing microbiome.
- The FDA to drop the GMP/lab requirements and allow donors to ship their stool directly to doctors.
- The FDA to create FMT-specific regulations that allow a project like this to exist.
Feel free to contact them. I do a lit review every day, and I've contacted hundreds of researchers. The vast majority do not respond. They don't appear to care at all; they're just doing their job, getting paid, and going home.
The only thing companies seem interested in is making "drugs" from poop; not actual FMT, much less FMT from high-quality donors.
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