Michael Harrop
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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. Blog
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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 recently tested a very good donor, and while they were very helpful in many ways, they were not "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 partnerships with research groups.
Expounding further for federal legislators:
There seems to be a severe deficiency in competence, motivation, and even being well-informed.
It appears to be due to a lack of market and competition-based incentives. The distribution of funds does not seem to be merit-based or based on their performance and accomplishments.
If the right incentives were in place, all the major universities would have been rushing to screen their student-athletes to find the most effective stool donors and demonstrate a panacea.
A group of some of the most well-known microbiome researchers wrote a paper about how catastrophic the loss of microbiome diversity is. Yet they did nothing about it despite being in a fantastic position to do so.
Many research groups do not have the ability to take on a project like this and screen huge amounts of donors, but most of the university research teams are in an excellent position to recruit from their student-athletes. These groups are the source of the vast majority of top professional athletes. Dr. Anthony Fauci is a good example of someone who is extremely healthy and who was a college athlete but didn't go on to be a pro. He likely would have made a good stool donor in his youth.
Some of it may have to do with universities giving tenured positions, which is basically researchers being set for life with a good job and automatic respect, as long as they don't f**k up really badly.
Whatever the cause, politicians can't keep blindly pouring billions of dollars into this extremely flawed research system.
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 recently tested a very good donor, and while they were very helpful in many ways, they were not "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 partnerships with research groups.
Expounding further for federal legislators:
There seems to be a severe deficiency in competence, motivation, and even being well-informed.
It appears to be due to a lack of market and competition-based incentives. The distribution of funds does not seem to be merit-based or based on their performance and accomplishments.
If the right incentives were in place, all the major universities would have been rushing to screen their student-athletes to find the most effective stool donors and demonstrate a panacea.
A group of some of the most well-known microbiome researchers wrote a paper about how catastrophic the loss of microbiome diversity is. Yet they did nothing about it despite being in a fantastic position to do so.
Many research groups do not have the ability to take on a project like this and screen huge amounts of donors, but most of the university research teams are in an excellent position to recruit from their student-athletes. These groups are the source of the vast majority of top professional athletes. Dr. Anthony Fauci is a good example of someone who is extremely healthy and who was a college athlete but didn't go on to be a pro. He likely would have made a good stool donor in his youth.
Some of it may have to do with universities giving tenured positions, which is basically researchers being set for life with a good job and automatic respect, as long as they don't f**k up really badly.
Whatever the cause, politicians can't keep blindly pouring billions of dollars into this extremely flawed research system.
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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I’ve put together a petition to push the FDA for real change: reclassify FMT, allow stool shipments directly to doctors, and encourage clinical trials using the best donors we’ve identified. The goal is to get their attention and start moving toward proper regulation that works for patients, not against them.
I was thinking we could spread this petition on subreddits and Facebook groups. We can also email it to the 1+ million donor applicants and our recipients.
Here is what it would say, let me know your thoughts:
“Petition to the FDA: Reclassify Fecal Microbiota Transplants (FMT) and Ensure Access to Safe, Effective Donors
We respectfully urge the FDA to reconsider its current classification of Fecal Microbiota Transplants (FMT) and remove the barriers that prevent patients from accessing high-quality, screened stool donors under safe and regulated conditions.
Background:
The gut microbiome is crucial to human health, influencing everything from digestion to immune function and even mental health. Fecal Microbiota Transplants (FMT) have shown incredible promise in restoring gut health and treating a range of conditions, including recurrent Clostridium difficile infections, inflammatory bowel disease, and possibly even certain cancers.
FMT works by transferring healthy gut microbes from a donor to a patient whose microbiome is out of balance, potentially restoring health. However, not all stool donors are equally effective, and finding truly safe and high-quality donors requires extensive screening. Despite the potential of FMT, the FDA currently classifies it as an unapproved drug, creating regulatory barriers that prevent patients from accessing the safest donors.
The Problem:
The FDA’s current regulations make it difficult for patients to access safe, highly screened donors. While hundreds of low-quality donors are currently being used for FMT (and even DIY procedures), Human Microbes—a patient-led project—has screened over 1.2 million people to identify the rare, high-quality donors that could offer the most effective treatment. However, the FDA’s classification of Human Microbes as a “drug manufacturer” has limited access to these valuable resources.
We understand that safety is a priority and that clinical trials are essential. However, patients should not be forced to take unnecessary risks with unqualified donors while access to safer alternatives is restricted.
Our Request:
We recognize that this petition is part of a broader effort to advance FMT research and access, but we believe the FDA can take immediate action by:
1. Reclassifying FMT: FMT should not be regulated as a traditional drug. It is a biological process that requires its own set of regulations, just as other countries have recognized. The FDA should create FMT-specific regulations that allow innovative projects like Human Microbes to operate safely and effectively.
2. Allowing stool shipments to doctors: The FDA should drop the current GMP (Good Manufacturing Practice) and lab requirements, allowing donors to ship their screened stool directly to doctors. This would facilitate access to safe donors and help patients receive timely treatment.
3. Encouraging clinical trials with top donors: We call on the FDA to support partnerships and funding for clinical trials comparing the safety and efficacy of Human Microbes’ top donors against the average FMT donors being used worldwide. This would provide critical data and further legitimize FMT as a viable treatment option.
4. Supporting research to clear the microbiome: We need funding and partnerships for animal and human studies to explore methods for clearing the existing microbiome. This research could open new doors for gut health treatments and further improve patient outcomes.
Why This Matters:
1. Patient Safety: Without access to high-quality donors, patients are often forced to use unsafe or ineffective stool donors, risking their health in the process.
2. Medical Necessity: For many patients, particularly those with conditions like C. difficile infections, FMT may be the only effective treatment option. Proper regulation and access to the best donors could save lives.
3. Public Health: Developing clear, FMT-specific regulations and allowing better donor access could revolutionize the treatment of gut-related diseases, reduce healthcare costs, and improve outcomes for countless patients.
While we understand the need for caution, we believe the FDA has a responsibility to protect public health by facilitating access to safe, effective FMT treatments. We hope this petition can contribute to advancing that goal by encouraging a regulatory framework that prioritizes safety, innovation, and patient care.
Sign this petition to demand that the FDA reclassify FMT and improve access to safe, effective treatment for patients in need!”
I was thinking we could spread this petition on subreddits and Facebook groups. We can also email it to the 1+ million donor applicants and our recipients.
Here is what it would say, let me know your thoughts:
“Petition to the FDA: Reclassify Fecal Microbiota Transplants (FMT) and Ensure Access to Safe, Effective Donors
We respectfully urge the FDA to reconsider its current classification of Fecal Microbiota Transplants (FMT) and remove the barriers that prevent patients from accessing high-quality, screened stool donors under safe and regulated conditions.
Background:
The gut microbiome is crucial to human health, influencing everything from digestion to immune function and even mental health. Fecal Microbiota Transplants (FMT) have shown incredible promise in restoring gut health and treating a range of conditions, including recurrent Clostridium difficile infections, inflammatory bowel disease, and possibly even certain cancers.
FMT works by transferring healthy gut microbes from a donor to a patient whose microbiome is out of balance, potentially restoring health. However, not all stool donors are equally effective, and finding truly safe and high-quality donors requires extensive screening. Despite the potential of FMT, the FDA currently classifies it as an unapproved drug, creating regulatory barriers that prevent patients from accessing the safest donors.
The Problem:
The FDA’s current regulations make it difficult for patients to access safe, highly screened donors. While hundreds of low-quality donors are currently being used for FMT (and even DIY procedures), Human Microbes—a patient-led project—has screened over 1.2 million people to identify the rare, high-quality donors that could offer the most effective treatment. However, the FDA’s classification of Human Microbes as a “drug manufacturer” has limited access to these valuable resources.
We understand that safety is a priority and that clinical trials are essential. However, patients should not be forced to take unnecessary risks with unqualified donors while access to safer alternatives is restricted.
Our Request:
We recognize that this petition is part of a broader effort to advance FMT research and access, but we believe the FDA can take immediate action by:
1. Reclassifying FMT: FMT should not be regulated as a traditional drug. It is a biological process that requires its own set of regulations, just as other countries have recognized. The FDA should create FMT-specific regulations that allow innovative projects like Human Microbes to operate safely and effectively.
2. Allowing stool shipments to doctors: The FDA should drop the current GMP (Good Manufacturing Practice) and lab requirements, allowing donors to ship their screened stool directly to doctors. This would facilitate access to safe donors and help patients receive timely treatment.
3. Encouraging clinical trials with top donors: We call on the FDA to support partnerships and funding for clinical trials comparing the safety and efficacy of Human Microbes’ top donors against the average FMT donors being used worldwide. This would provide critical data and further legitimize FMT as a viable treatment option.
4. Supporting research to clear the microbiome: We need funding and partnerships for animal and human studies to explore methods for clearing the existing microbiome. This research could open new doors for gut health treatments and further improve patient outcomes.
Why This Matters:
1. Patient Safety: Without access to high-quality donors, patients are often forced to use unsafe or ineffective stool donors, risking their health in the process.
2. Medical Necessity: For many patients, particularly those with conditions like C. difficile infections, FMT may be the only effective treatment option. Proper regulation and access to the best donors could save lives.
3. Public Health: Developing clear, FMT-specific regulations and allowing better donor access could revolutionize the treatment of gut-related diseases, reduce healthcare costs, and improve outcomes for countless patients.
While we understand the need for caution, we believe the FDA has a responsibility to protect public health by facilitating access to safe, effective FMT treatments. We hope this petition can contribute to advancing that goal by encouraging a regulatory framework that prioritizes safety, innovation, and patient care.
Sign this petition to demand that the FDA reclassify FMT and improve access to safe, effective treatment for patients in need!”
OP
Michael Harrop
Active member
- Thread Starter
- #15
Thanks for the effort. It's not bad overall. I'll be interested to hear what other people think.
This is why my main focus is going to be on petitioning federal legislators to obtain clinical trials, as I don't think the FDA can solve all the problems on their own. I think that if we can demonstrate safety and efficacy in a clinical trial the FDA would be more inclined to create supporting regulations.
I think we also need to focus outside reddit and facebook groups. The people there seem to be severely deficient in motivation, and other critical characteristics... However, based on my emails to donor applicants, that may be broadly applicable to the vast majority of the population, regardless of where they spend their time. But video and image platforms like Instagram and TikTok, seem to be where most people are. I don't use them though so I don't know how to reach people there. Twitter is also popular and I've had no success in reaching people there.
#3 and #4 are not up to the FDA, as far as I know. It would be up to federal legislators to provide monetary incentives, or perhaps create a unique FMT project (maybe something similar to the $1 billion COVID moonshot proposal). I think a very good argument could be made that the chronic disease crisis deserves a Manhattan-Project-like clone, with a primary focus on the gut microbiome and FMT.
This is why my main focus is going to be on petitioning federal legislators to obtain clinical trials, as I don't think the FDA can solve all the problems on their own. I think that if we can demonstrate safety and efficacy in a clinical trial the FDA would be more inclined to create supporting regulations.
I think we also need to focus outside reddit and facebook groups. The people there seem to be severely deficient in motivation, and other critical characteristics... However, based on my emails to donor applicants, that may be broadly applicable to the vast majority of the population, regardless of where they spend their time. But video and image platforms like Instagram and TikTok, seem to be where most people are. I don't use them though so I don't know how to reach people there. Twitter is also popular and I've had no success in reaching people there.
What if we say something along these lines:
“3. Support clinical trials using top donors: Federal funding and partnerships are necessary to conduct large-scale clinical trials that compare the safety and efficacy of high-quality donors—like those identified by Human Microbes—against the average FMT donors currently being used. Such trials would provide essential data to further establish FMT as a reliable treatment option and help the FDA develop informed regulations.
4. Prioritize gut microbiome research: We call on legislators to consider launching a national initiative, similar to a “Manhattan Project” or “moonshot” program, to focus on preventing and treating chronic diseases through gut microbiome research. Given the gut’s influence on a wide range of health conditions, advancing research into methods like microbiome clearing and FMT could revolutionize treatment options and significantly improve public health outcomes”
Im pretty familiar with those platforms, I could help with that if you’d like.
“3. Support clinical trials using top donors: Federal funding and partnerships are necessary to conduct large-scale clinical trials that compare the safety and efficacy of high-quality donors—like those identified by Human Microbes—against the average FMT donors currently being used. Such trials would provide essential data to further establish FMT as a reliable treatment option and help the FDA develop informed regulations.
4. Prioritize gut microbiome research: We call on legislators to consider launching a national initiative, similar to a “Manhattan Project” or “moonshot” program, to focus on preventing and treating chronic diseases through gut microbiome research. Given the gut’s influence on a wide range of health conditions, advancing research into methods like microbiome clearing and FMT could revolutionize treatment options and significantly improve public health outcomes”
Im pretty familiar with those platforms, I could help with that if you’d like.
OP
Michael Harrop
Active member
- Thread Starter
- #17
Who are you addressing the petition to? If you're addressing it directly to the FDA I don't think it's applicable. If you're just making a general petition to no one in particular to show that "X number of people are willing to sign this", then it's applicable but perhaps less effective. Or perhaps it can be addressed to both the FDA and federal legislators.
But are there really enough well-informed people who would advocate for a "Manhattan-like project" for the gut microbiome? I highly doubt it. I even doubt you could get more than 10% of people working in the microbiome field to sign such a petition. As I've said, in my experience, the vast majority of people are poorly informed and completely apathetic, regardless of their profession.
This is why for the last few months I've been preparing to travel to Washington DC to protest. I don't think I can rely on anyone to do anything, and I'm very doubtful that it's worth the effort to continue focusing on trying to get the general public to assist.
We've contacted the Congressional Crohn’s and Colitis Caucus and received no response. I've contacted numerous disease advocacy organizations and received no response. I've contacted microbiome researchers who write about how catastrophic the microbiome extinction is. These should be the most well-informed and motivated people/groups, yet they do nothing.
In my experience, the general public is even less informed & motivated. Tens of thousands of people who would personally greatly benefit from FMT saw the social media posts you made and nearly all of them did nothing. That matches my own experiences over the past 10 years. Out of the entire patient community that knows about FMT and this project, you are virtually the only one doing anything. Out of the entire medical and research communities, whose job it is, and whom everyone's lives depend on, 0 out of hundreds of thousands are doing anything about this. One of the Remission Biome guys made a nice tweet about it, and no one did anything.
But are there really enough well-informed people who would advocate for a "Manhattan-like project" for the gut microbiome? I highly doubt it. I even doubt you could get more than 10% of people working in the microbiome field to sign such a petition. As I've said, in my experience, the vast majority of people are poorly informed and completely apathetic, regardless of their profession.
This is why for the last few months I've been preparing to travel to Washington DC to protest. I don't think I can rely on anyone to do anything, and I'm very doubtful that it's worth the effort to continue focusing on trying to get the general public to assist.
We've contacted the Congressional Crohn’s and Colitis Caucus and received no response. I've contacted numerous disease advocacy organizations and received no response. I've contacted microbiome researchers who write about how catastrophic the microbiome extinction is. These should be the most well-informed and motivated people/groups, yet they do nothing.
In my experience, the general public is even less informed & motivated. Tens of thousands of people who would personally greatly benefit from FMT saw the social media posts you made and nearly all of them did nothing. That matches my own experiences over the past 10 years. Out of the entire patient community that knows about FMT and this project, you are virtually the only one doing anything. Out of the entire medical and research communities, whose job it is, and whom everyone's lives depend on, 0 out of hundreds of thousands are doing anything about this. One of the Remission Biome guys made a nice tweet about it, and no one did anything.
Sure! You can email me about that.
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I could address it to federal legislators or just the general public to raise awareness.
Its truly mind boggling.
Will do.
OP
Michael Harrop
Active member
- Thread Starter
- #19
Relevant info about RFK and Trump: https://forum.humanmicrobiome.info/threads/incoming-trump-admin-with-rfk-signals-new-start-for-fda.706/
Crap, sorry, I got distracted with work and completely forgot about that summary.
For broad dispersion, I would suggest something like this - note that ideally there should be hyperlinked sources in the middle, but I'm not familiar enough to know which studies are the most convincing. Additionally, you could link more detailed pages for information/followup at the end, but the initial plea should be short:
Dear [Health Official],
The human microbiome plays a vital role in overall health, and emerging research indicates fecal matter transplants (FMTs - imagine pills of healthy stool) can be an effective treatment for chronic illnesses and autoimmune conditions, including arthritis, Crohn's, and multiple sclerosis.
However, FMT providers are being shut down because the FDA classifies FMT procedures as drug manufacturing. Existing regulations and laws provide no recourse for patients desperate for this potentially life-changing treatment. Clinical research indicates this treatment is most effective and safe when using donor material from exceptionally healthy individuals. Without these businesses, patients have no feasible access to such a donor. None of the existing Right To Try laws cover this scenario.
I urge you to consider updates that would enable greater access to reliable FMT treatments. Patients suffering from debilitating chronic and autoimmune conditions deserve every opportunity to improve their health and quality of life.
Thank you for your consideration.
Sincerely,
[Your Name]
For broad dispersion, I would suggest something like this - note that ideally there should be hyperlinked sources in the middle, but I'm not familiar enough to know which studies are the most convincing. Additionally, you could link more detailed pages for information/followup at the end, but the initial plea should be short:
Dear [Health Official],
The human microbiome plays a vital role in overall health, and emerging research indicates fecal matter transplants (FMTs - imagine pills of healthy stool) can be an effective treatment for chronic illnesses and autoimmune conditions, including arthritis, Crohn's, and multiple sclerosis.
However, FMT providers are being shut down because the FDA classifies FMT procedures as drug manufacturing. Existing regulations and laws provide no recourse for patients desperate for this potentially life-changing treatment. Clinical research indicates this treatment is most effective and safe when using donor material from exceptionally healthy individuals. Without these businesses, patients have no feasible access to such a donor. None of the existing Right To Try laws cover this scenario.
I urge you to consider updates that would enable greater access to reliable FMT treatments. Patients suffering from debilitating chronic and autoimmune conditions deserve every opportunity to improve their health and quality of life.
Thank you for your consideration.
Sincerely,
[Your Name]
OP
Michael Harrop
Active member
- Thread Starter
- #21
I'm in DC.
There's no parking around the Capitol so you have to take the subway. This means I have to carry a backpack and something to sit on, and there's lots of walking. In my poor health condition this is way too much to do every day. My body is weak and I was in a lot of pain at the end of the day.
A wheelchair and/or a rolling bag would help, but it seems to be a completely useless thing to do anyway, and thus I have to figure out something else to do.
- The vast majority of people didn't even read my sign; they tried to completely ignore me, despite me being someone who generally stands out. People generally do not ignore me. This is unusual.
- Of the people who did read my sign, as far as I could tell, no one scanned the QR code to learn more. The sign says "A cure for chronic disease needs special attention QR". Many of the people who read the sign were visibly unhealthy and thus have a personal interest in the matter, and still, they don't care.
- While you can technically "protest at the capitol", there doesn't seem to be a useful place to do so unless you have hundreds or thousands of people with you, and news media to cover it. A guard told me that the main Capitol steps have been locked off since 9/11 (maybe he meant that main entrance). An added bonus is that an even larger area around it is locked off because they're already building an inauguration stage. But even if that wasn't the case, it would largely be laypeople visiting the Capitol who see you protest -- and we know that laypeople don't give a shit.
- There's another entrance to the Capitol for lawmakers, but I don't know how often, or when, they use it.
- Even if I was able to be at that entrance when all legislators were going inside, based on my experience so far, I expect most of them would not read the sign, and none of them would scan the code.
- There are limited restrooms at the Capitol, so you have to walk a lot.
- You can't take signs into the buildings.
- Even if you could or tried to protest inside the buildings, the legislators don't seem to stay in their main/labeled offices. So you'd be essentially just sitting in the hallway hoping to randomly spot and briefly talk to a random legislator, which I don't think will be effective.
- There were not a lot of people coming and going, and there are six different buildings with numerous entrances and exits, so a single person holding a sign gets seen by very few people.
- Of the people I did see, I didn't recognize any Senate or House members. I'm not sure if most of the people I saw were staffers, visitors or lobbyists, but none of them cared.
I guess the circumstances were significantly different for this tactic to work for Greta Thunberg.
Amazingly, I spotted Medea Benjamin in one of the buildings and I asked her for advice. I'll be following up on her suggestion and another idea I have.
I have to wonder if the majority of people, legislators included, consider the main roadblock here to be scientific/medical, rather than legislative. In other words, they think that we first need to figure out the optimal way to technically carry out a FMT (including, but certainly NOT limited to, donor criteria), before it can be advocated for the mainstream.
Your own experience shows that even spending a large part of one's life searching for donors, and having a good idea what kind of person you are looking for, it is still really difficult to reliably find people who help you. In my case, I have tried capsules from three donors so far on my own (one from Human Microbes, two from another source) and while I have significantly improved, I'm still not back to where I was after my hospital FMT. Dr. El-Salhy's work in Norway suggests that administration route is very important, that is the next thing I will experiment with.
But it's not like anyone here can point to a "magic" donor and method (that they actually HAVE access to--not some ideal set of criteria for some imaginary donor who we haven't actually TRIED), who is guaranteed to cure everyone. Testing and trying donors to find someone costs money. You may be thinking that if the FDA freely allowed FMT, there would be a plethora of companies willing to sink in the R&D costs to find ideal donors and procedures, but I'm not so sure there are.
The point of this all is, I don't think that one patient who has had limited success finding a donor for himself/herself can sway the general public very much about the need for commercial donors. It needs multiple patients who have actually been cured or drastically improved by FMT to join together to tell their stories. In other words, people who can say "if what I had was legal for everyone, we could all benefit". The fact that you lost the donors who were most helpful to you after one donation had nothing to do with FMT laws.
Your own experience shows that even spending a large part of one's life searching for donors, and having a good idea what kind of person you are looking for, it is still really difficult to reliably find people who help you. In my case, I have tried capsules from three donors so far on my own (one from Human Microbes, two from another source) and while I have significantly improved, I'm still not back to where I was after my hospital FMT. Dr. El-Salhy's work in Norway suggests that administration route is very important, that is the next thing I will experiment with.
But it's not like anyone here can point to a "magic" donor and method (that they actually HAVE access to--not some ideal set of criteria for some imaginary donor who we haven't actually TRIED), who is guaranteed to cure everyone. Testing and trying donors to find someone costs money. You may be thinking that if the FDA freely allowed FMT, there would be a plethora of companies willing to sink in the R&D costs to find ideal donors and procedures, but I'm not so sure there are.
The point of this all is, I don't think that one patient who has had limited success finding a donor for himself/herself can sway the general public very much about the need for commercial donors. It needs multiple patients who have actually been cured or drastically improved by FMT to join together to tell their stories. In other words, people who can say "if what I had was legal for everyone, we could all benefit". The fact that you lost the donors who were most helpful to you after one donation had nothing to do with FMT laws.
OP
Michael Harrop
Active member
- Thread Starter
- #23
A general update:
I visited my California legislators' offices. One of the healthcare staffers told me they're so busy that despite my contacting them in August they won't even have the chance to discuss my issue with their boss until mid-December.
My other CA legislator has also not responded, and when I visited their office they gave me another contact and suggestion that I'm following up on.
My 3rd legislator seems to only be holding the office till their replacement arrives in January, and they don't even answer their phones.
Bernie Sanders:
As you may know, Bernie launched the $1 billion long COVID moonshot proposal. He's also the chair of the Senate Health Committee. I contacted his office, then visited, and a healthcare staffer met with me. She has read "Missing Microbes" and seemed interested in helping.
NIH:
I wrote to the NIH (after her reminder), and they told me:
Which is what I've already done/been doing for the past decade.
This is a huge part of what I'm doing, so I don't think that makes sense.
I'll reference the 4 bullet points I listed in this previous comment that lay out what I'm asking for.
Regarding your 3rd paragraph, no, that's not what I have in mind. I discussed that previously in this thread. I reference those 4 bullet points again as well. I do not think any company is going to spend lots of money on finding stool donors since a stool donor can't be patented. That's a huge part of the reason why there needs to be government or philanthropic funding for a project like this.
I've never argued for the FDA to "freely allow FMT" either. That would be horrible and I've argued against that for many years.
I think your 4th paragraph is way off base as well, and it appears that you didn't read, or remember, what I wrote on the blogs. In particular, the second to last paragraph of the blog this thread is about.
I don't think you need multiple patients who've benefited from a super-donor in order to make progress. There is ample evidence and rationale for why the government, the public research system, and philanthropists should back FMT and a project like this. And it's all laid out in the blogs.
However, there are a good number of those people whose experiences I've been trying to catalog in the "personal donors" section. They went back to living a normal life. They're not spending time trying to help anyone else get access to FMT. But you're welcome to try to get in contact with them about your idea.
If you mean a new one, other than Openbiome, will you be posting to the Clinics section about it?
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What is "a project like this"? In other words, who gets to decide who the recipients are, what the inclusion/exclusion criteria are for people being treated, and analyzes the results (including determining what counts as a "success" or doesn't? What route of administration will be tested? As someone on the autism spectrum, I contacted the ASU team that is running clinical trials for adults, about whether I could enroll, and they said they had far more interest than they had spots in the trials for people.
As for your four requests:
- 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.
About "my idea"? What these people need to do is all convey to the FDA how much FMT helped them. Something along the lines of signing a petition, along with the opportunity for individual stories.
I will eventually. I was going to wait until I was fully through trying all they have to offer. Unfortunately though, they have stopped shipment to the US at least for the time being due to customs concerns (there's another concrete place where regulations could change for the better). So I might not be able to try them any more and might just need to report the experiences I've already had, for the benefit of the non-US patients who can still order from them. They're not a clinic, they're another mail order business.
OP
Michael Harrop
Active member
- Thread Starter
- #25
As is, this project has been all-inclusive. When going the clinical trial route we'd have to pick one condition per trial. It really depends on how the clinical trial comes to be. Using your autism example, if the remaining people wanting to get into the ASU trial want to start up a new crowdfunding effort to get another trial going then we'd pick autism.
Yes, it seems that there is ample demand for FMT clinical trials, and we may be able to crowdfund another one. I just have no clue how to go about such a thing, and no one has volunteered to help.
As I noted in my previous comment, NIH doesn't fund or even help projects like this. So there's a huge gap in coverage, and we see that glaringly with this project -- it takes on an extremely important need that has been ignored for decades, it's illegal for us to do on our own, and there's no official way to get support and funding. Thus, it's up to legislators to recognize and fix this major deficiency.
None of this is correct. Please review previous information before engaging in discussion. This has all been covered already.
I would assume the FDA is aware of such stories already. I highly doubt it would have any impact. But as I said, you're welcome to try to contact them and persuade them to do something.
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Here is a list of federal and state legislators we should be contacting:
1. Senators and Representatives
- U.S. Senators: Each state has two senators who vote on national healthcare policies. You can find and contact them here.
- U.S. Representative: Your representative in the House focuses on your district’s needs, including healthcare issues. Use your ZIP code to locate them here.
2. Committees Involved in Healthcare Policy
Committees that play a big role in legislation and funding for medical research:- Senate Health, Education, Labor, and Pensions (HELP) Committee
- They make decisions on healthcare policies that affect access to treatments like FMT.
- Chair: Senator Bernie Sanders
- Contact Page
- Phone: (202) 224-5824
- Ranking Member:Senator Bill Cassidy
- Contact page
- Phone: (202) 224-5824
- Committee Email: [email protected]
- House Energy and Commerce Committee – Health Subcommittee
- They oversees all things health-related, including the FDA and public health laws.
- Chair:Rep. Brett Guthrie
- Contact page
- Phone: (202) 225-3501
- Ranking Member: Anna Eshoo
- Contact page
- Phone: (202) 225-8104
- Senate and House Appropriations Committees
- They help decide where federal money goes, including funds for medical research and healthcare programs.
- Senate Subcommittee Chair: Senator Tammy Baldwin
- Contact page
- Phone: (202) 224-5653
- House Subcommittee Chair: Rep. Robert Aderholt
- Contact page
- Phone: (202) 224-6472
3. State Legislators (State Representative & State Senators)
You can also contact your State Representative and State Senator. Many states have specific committees on health policy.- State Representatives: Visit your state’s legislative website. For example, in Michigan, you can find contact info through here: https://www.legislature.mi.gov/
- State Senators: You can find contact details for your state senator here: https://www.senate.gov/states/statesmap.htm