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

[Michael Harrop]

Hopefully the same goes for his general tone about other people, the state of the world, and the role of his own work in the whole thing.

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It's factual information that needs to be said because you can't solve a problem without diagnosing it first. If you have alternative theories for the state of things, or counter arguments against my statements, you're free and encouraged to write them.

My criticisms are backed by a plethora of evidence, and I think they are more than appropriate, especially coming from a disabled patient whose life is being stolen from them by incompetent and apathetic people.

 

[Michael Harrop]

Senator Cassidy:​

I have been waiting outside Senator Cassidy's office most days. At first, it seemed like he and his staff were avoiding me, but then for two days in a row he acknowledged me and I nodded to him without saying anything. He finally approached me and said hello and I asked him if his staff had told him why I was there. He said no. I gave him a brief overview of the situation and handed him more info, and he said he'd look into it.

He seemed less informed about FMT than Marco Rubio. However, during the 2nd RFK hearing he had a laptop with him and looked up one of RFK's citations in real-time, so he seems capable and inclined to learn about new science himself. During the hearing, he said he's been out of medical practice for 15 years. From my interaction with him, and the hearings, he seems likable, genuine, and competent. He convinced me that he would learn more about the microbiome and FMT over the next week and get back to me.

Cassidy's HELP staffer:​

For the past couple of days, I also left flyers under the doors of the HELP staff offices. After Senator Cassidy talked to me, I decided to wait outside the HELP staff office instead. Around 2 hours after I talked to the Senator, and around the time I was waiting outside the Health Majority office, Senator Cassidy's HELP staffer emailed me:

Hi Michael,

My apologies for this delayed response. I appreciate the work you are doing and the importance of FMT as a cutting-edge intervention that may have clinical benefit for a wide array of patients.

Unfortunately, the information you’ve received from NIH and FDA is accurate, to my knowledge. To receive NIH funding, many patient advocates choose to partner with researchers at academic institutions to submit applications. If you have not done so already, as a next step, I recommend seeking out likeminded academic researchers or small businesses to identify any opportunities to collaborate and apply for NIH funding.

Given our role overseeing HHS agencies and ethical considerations, the Committee does not weigh in on NIH or FDA decisions related to individual applications for research funding or regulatory approval. Your home state senators, however, may have different office policies that enable them to weigh in with NIH and FDA, or they may be able to work with you on developing draft legislation to address this issue if you would like to do so.

I’m sorry that I cannot be more helpful to you and am unable to provide further assistance.

Best,

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It's erroneous information that I'll dispute with her, and which highlights that she didn't even read all the information I shared, but it also highlights the potential for @indigo34's Senator to play a key role, and lack an excuse to dismiss us without helping, given that he is both her home Senator and on the HELP committee. They promised her they'd respond in two weeks, so that's something to look forward to. He seems like a friendly guy as well. A while back, he walked by me near the entrance to the building and said hello to me (a complete stranger) and other people.

I'm doubtful that this email was a result of Senator Cassidy talking to her about it. I think there's hope that Dr Cassidy will still review it on his own and see how promising and important it is.

Her response does highlight the fact that there's not a clear solution here, and the bullet points of minimum requirements that I created can probably be improved. Part of the problem is that they keep asking me for a solution and I don't know what exactly they're capable of. I need them to discuss it and come up with possible solutions.

When I was telling Dr. Cassidy about it, he asked "So what do you want from me?". I handed him the flyer with the bullet points, but I also said "I think you need to discuss it with your staff and NIH".

I'm considering changing the bullet points to something like:

• There's a cure for numerous diseases, including mine.
• I should be able to access this cure.
• I should not be responsible for making this cure available.
• I will never be able to access it unless someone in the federal government does something.

I think I'm even going to shorten the whole flyer to that.

RFK hearings:​

https://forum.humanmicrobiome.info/threads/incoming-trump-admin-with-rfk-signals-new-start-for-fda.706/post-2063

Staffers:​

Since it seems that overwhelmingly, the congressional staffers ignore this issue, don't fully review it, and don't pass it on or discuss it with the Senators, our best hope is likely to directly reach a Senator who cares and is willing to do something.

After leaving flyers with the Health minority staffers, I saw some of them reading them and laughing. Here's one of the flyers.

I'm now thinking it's possible that @Otto Kretschmer and @SFBayFMT5 may be right about some of the staffers being incompetent and apathetic, and perhaps reacting with derision to something new & unusual to them. I certainly did not get that feeling from Sanders' HELP staffer I met with. She seemed knowledgeable, competent, and willing to help. That hasn't been the case for Cassidy's HELP staffer. I have followed up with Sanders' staffer and haven't heard back.


Misc:

I spoke to a nurse outside Cassidy's office. He was dressed well in a suit and at first glance would be taken much more seriously than me. But as he talked it became clear he was worse off than me, largely due to a myriad of health problems, such as sleep deprivation/narcolepsy, ADHD, and more. So much so that he was unable to read and learn the info I shared with him about the microbiome and FMT. It felt like a summary of the past decade -- I need help so badly, and here's this other person suffering and in a great position to help me and himself, but instead of getting help I'm having to carry everyone across the desert with me.

 

[indigo34]

A while back, he walked by me near the entrance to the building and said hello to me (a complete stranger) and other people.

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That's called Southern hospitality. One of the nice things about living in Virginia

it also highlights the potential for @indigo34's Senator to play a key role, and lack an excuse to dismiss us without helping, given that he is both her home Senator and on the HELP committee. They promised her they'd respond in two weeks,

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It has been two weeks and I haven't gotten a response. I can try calling their office next week to follow up. I'll email you the comment I submitted on their website. There wasn't an option for a meeting request unfortunately.

 

[SFBayFMT5]

Spoiler: Erroneous, off-topic reply

It's factual information that needs to be said because you can't solve a problem without diagnosing it first. If you have alternative theories for the state of things, or counter arguments against my statements, you're free and encouraged to write them.

My criticisms are backed by a plethora of evidence, and I think they are more than appropriate, especially coming from a disabled patient whose life is being stolen from them by incompetent and apathetic people.

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What I mean by tone is this... in a number of your posts, you come across as if you believe the following:

1. The FMTs you have sold are so much superior to FMTs from ANY other provider, that anyone who uses a different provider is wasting his or her time
2. Building off point 1, you have solved the donor selection problem for FMT once and for all, for all recipients
3. Since your donor criteria don't rely on testing a donor for pathogens more than once, anyone who does so is wasting money that should instead be devoted to recruiting donors from the ~0.0001% (I'm making up a number there--but the point is, it's tiny) of the population who is healthiest.
4. FMT will cure all or at least nearly all human diseases, therefore medical research into most other things is a waste of time and money
5. On top of that, FMT will "cure" things that most people don't even think of as "diseases", like political conflicts, and everyone not being an Olympic class athlete. And going along with this, the vast majority of the population is "ill".
6. Anyone who doesn't believe the above is an idiot.

The reality, as I see it, is:

1. Anyone who follows experience reports from a variety of FMT providers, or who has even personally TRIED FMTs from several providers (like myself), knows that your FMTs have a level of success very similar to that of other providers. Yes, you have a much larger pool of potential donors, and for that reason, it would be significantly more likely for someone to find a compatible donor among them than from a provider with only 1 or 2 donors. However, VERY few of these potential donors have ever been "activated", meaning that in practice you have the same number or even fewer donors actively donating than competing providers.
2. You have a significant amount of valuable experience on which donors work FOR YOU, as well as a decently sized collection of statistics on who else benefits from your donors. However, you have nowhere NEAR enough data to conclude that you could, with certainty, pick a donor for someone else that will work. I recently got worse from a donor that the provider has said had not previously made anyone else worse, and who greatly helped someone I personally communicated with--showing that there is NO perfect donor even if that person has helped many people in the past. And, even if you know which donors work for you, you haven't solved the problem of holding onto them so they keep donating--except for maybe if you paid them millions of dollars--but NO medical system can bear the cost of an intervention that sells for a million dollars for a course of treatment, especially when my OpenBiome donor, who worked extremely well and better than either of the other providers I've used (including Human Microbes), was paid a tiny fraction of that.
3. Testing for pathogens isn't about making sure someone will cure a recipient--it's about screening out KNOWN reasons a FMT might make someone dramatically WORSE. And people with a decent microbiome aren't super rare, most of us get our microbiome as babies from people who are NOT in the top 0.0001% of the population in anything.
4. I agree that a great number of cases of "chronic mystery disease" will respond dramatically to FMT. In other words, things along the lines of ME/CFS, fibromyalgia, PANS, post-Lyme syndrome, etc. In other words, cases where someone goes from being well to feeling "not like himself/herself", in a multisystem way that eludes medical understanding. The same goes for many GI conditions like IBS, IBD, gastric reflux, gallstones, etc., as well as many metabolic disorders. However, I find it very unlikely that FMT will cure late stage cancer, and it certainly won't cause a missing limb to regrow or fix a genetic defect like muscular dystrophy.
5. Most people are well enough to work a decent job and take care of themselves. That doesn't qualify as "ill", and doesn't mean they are horrible donors OR that they need FMT.
6. Most people who don't believe the above are not ready to jump to such conclusions because A) they haven't been sick enough to need a FMT, or B) they are not willing to take the gamble that a donor (including one of yours) might make them worse.


I get that you have valuable information to contribute to the discussion of how to improve FMT. And it's awful that people put roadblocks in your way rather than seeking to use this information to help people. I totally get that the way things are, you can't even DO the experiments that would determine to what degree you're on the right track. But to counter-react by claiming that you, and only you, have the answer to all of medicine, or even that you are the only one who truly even cares about trying to help people, really hurts your cause. That's the kind of thing that quacks say. And I've seen writings of yours where you don't claim this sort of stuff--where you acknowledge that we're still learning about FMT and that you are just doing your part to help move it forward--but you have to make sure that this is the first impression you make to people like the members of Congress in charge of medical policy.

 

[Michael Harrop]

Spoiler: Response to erroneous, off-topic comment

Anyone who follows experience reports from a variety of FMT providers, or who has even personally TRIED FMTs from several providers (like myself), knows that your FMTs have a level of success very similar to that of other providers

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This is not correct, and as a science degree holder, you should know better. It may be correct for your personal experience, but for it to be broadly correct the other providers would need to systematically track and publish results. The vast majority of people don't bother to write up a detailed post here when they get worse from one of those other providers; whereas, I specifically demand/require people report their results regardless of the outcome.

One of the people who claims success from one of those providers appears not to be a legimate experience, but rather a paid or incentivized advertiser. Other people make brief comments here and there about getting worse from them.

to conclude that you could, with certainty, pick a donor for someone else that will work

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I largely agree (and have said as much), especially in regard to my current donor pool, but I don't think it fully extends to my donor quality hypothesis -- if I'm able to find an ideal donor.

I recently got worse from a donor that the provider has said had not previously made anyone else worse

someone I personally communicated with

showing that there is NO perfect donor even if that person has helped many people in the past

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You are ordering from some very sketchy sources that are likely not being honest with you and others. And that person you communicated with may not be completely legitimate (see above).

That's also a ridiculous and erroneous conclusion, and demonstrates that you're not absorbing prior information that you're given.

Testing for pathogens isn't about

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I'm well aware of that. This is not the correct thread to discuss this though.

Your first #3 is not true. Your second #3 is completely nonsensical and non sequitur.

Your comment overall is very frustrating to read. You're clearly not understanding and absorbing existing information. You're coming to ridiculous and erroneous conclusions all the time in nearly every discussion you're a part of.

#4 is pretty silly and again not the place for this. https://humanmicrobiome.info/genetics/

#5 is both largely wrong and a strawman. If you want to discuss this stuff there are other threads for it.

#6, not an idiot, but certainly not well-informed on the subject.

Some of your last paragraph is a strawman (as is much of your whole comment) and also incorrect given that I cite a plethora of evidence for my claims.

you have to make sure that this is the first impression you make to people like the members of Congress in charge of medical policy

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This is not a factor at all. As noted in my last update, and as you'll see in my next update: 1) I give them the barebones. 2) They largely don't even bother to review that, much less dig deeper in and misconstrue things as in your outline.

EDIT: Based on SFBay's continued remarks in other threads, it appears he was/is being deliberately deceitful.

 

[Michael Harrop]

Content of letters I've been sending:​

Questions about the content of what I'm sending to Congressional offices have come up so here's a variant of what I was sending them in the beginning:

I'm a disabled patient trying to obtain a currently-existing treatment (if not cure). The FDA is restricting it, and it's not getting the attention it needs because it can't be patented and the public research system has shown itself to be unable to take on a unique project like what is required for this. Thus, it needs very unique support. Here is a summary of the situation:
https://forum.humanmicrobiome.info/threads/the-fda-and-fmt-regulation-part-2-jul-2024-humanmicrobes-org-i-met-wit.520/post-1370

I drove to DC from California to protest because none of my representatives have responded. So I'm here to meet with anyone who will help. I'm not willing to sit around and waste away while a treatment/cure exists.

I know from experience that FMT from a good enough stool donor can restore me to essentially full function. But it requires continued treatment, and such donors are extremely rare.

I have written extensively about why the chronic disease crisis deserves its own "Manhattan Project" focused on the gut microbiome and FMT. Eg:

• https://forum.humanmicrobiome.info/threads/while-antibiotic-resistance-gets-all-the-attention-the-damage-being-do.50/
• https://www.humanmicrobes.org/blog/stool-donors-one-in-a-million-ai-funding-potential

Summary: Many of these diseases decrease brain function [1][2]. You cannot have a well-functioning society, especially a democracy, where the majority of people are poorly functioning, malfunctioning, incompetent, unintelligent, etc. And existential threats like AI are much more risky under these circumstances.

But at minimum, 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.

I recruited and screened over 1.3 million stool donor applicants who applied based on social media videos other people made. But this applicant pool is far from ideal. I need the ability to reach top world athletes. I shouldn't be having to do this alone; and even worse now, not at all.

I was very heartened to hear RFK put such a strong focus on chronic disease. Perhaps you can even put me in touch with RFK to find out what he thinks about this?

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That's roughly what I was sending to NIH, HHS, etc. as well.

I followed up later with some of the Senate Health Committee members with this (as part of a meeting request):

* What is your general opinion of this issue? No big deal; patients just need to wait a few more decades (if ever) until someone with money decides to undertake or fund a project like this? Or is this indeed a major shortcoming of the current system resulting in the unavailability of a simple treatment that could have and should have been available many years ago?

* If you agree that it's a major deficit, what do you think can be done for this situation and similar situations in the future? Create mechanisms that allow motivated, knowledgeable individuals to partner with research groups to conduct clinical trials? Create an incentive structure for public research groups to conduct trials that lead to significant outcomes?

In my opinion, the fact that university research groups have not undertaken a major campaign to recruit stool donors from their student-athletes and attempt to find the most effective donors among them, and thus likely discover a treatment/cure for nearly every chronic disease, indicates that there are major structural deficiencies and/or roadblocks, possibly including incompetence and apathy. The fact that a disabled patient was forced to undertake a project like this on their own, illegally, with no assistance or funding, and then all public research groups still ignored the project instead of taking advantage of my work and the answers I made public, and partnering with me to run clinical trials, and instead continued to run failed clinical trials with their own low-quality donors.

They write papers like this one https://forum.humanmicrobiome.info/threads/preserving-microbial-diversity-oct-2018.506/ about how big of a problem it is, and then despite having access to university resources and funding, huge bodies of student-athletes, many of whom go on to be professional athletes, and already regularly conduct research and clinical trials, they do not take on a project like this that actually addresses the core issue.

It seems purely academic to them. Thus, it cannot be entirely left up to them.

* If you agree that this situation has highlighted major deficiencies, will you be discussing it with the Senate Health Committee to come up with solutions?

As noted further on in that forum thread, NIH does not grant funding to individuals like me. So there is no path for me to be able to run a project like this legitimately (clinical trials, etc.). Additionally, had I not illegally started doing this it would certainly have never been done. I made major, extremely important discoveries by finding my own donors and doing "DIY FMT" with more than 15 different donors now. And other patients doing the same thing have also contributed important experiences and feedback. I would argue that I've become the #1 world expert on FMT. I have the motivation, competence, and knowledge to run a project like this, but not the legal pathway for funding, partnerships, and clinical trials.

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After one of the staffers clearly didn't review the info and asked me for an even shorter summary & goals, I created this:

The most succinct I can get:
FMT is a treatment/cure for numerous chronic diseases. The main issues are 1. donor quality, and 2. clearing the existing microbiome.

A stool donor can't be patented. You can spend 4 years trying to find a "super-donor", then they can stop/leave for a variety of reasons and you just lost 4 years. So this isn't being pursued by people with financial interest.

The other option is the public research system, but they've demonstrated an unwillingness/incapability to take on the donor quality aspect. They only test a few local donors that they're able to easily obtain. So their results are poor, and even harmful to patients.

As a disabled patient, I'm not willing to sit around and waste away while a cure exists and no one's motivated enough to obtain it. So I started looking for donors myself, and over 4 years I screened 1.2 million applicants. Now the FDA says I cannot proceed without running clinical trials, but I don't have the resources to do that and NIH does not provide funding or partnerships to individuals like me, so I'm out of options.

Unless something unique is done this treatment for numerous chronic diseases will never be available to anyone. It's a completely absurd situation given how worthless poop is, how powerful it can be, and how little attention it's getting when more than 6 in 10 Americans suffer from chronic disease. A single disabled patient should not have to be struggling alone at this.

For the past decade, I have been contacting everyone (individual researchers, doctors, research groups, philanthropic individuals & institutions, wealthy & sick individuals, state and federal legislators, HHS, NIH, FDA, etc.), and getting help from no one.

Top NFL, NBA, etc. athletes' poop could likely cure numerous chronic diseases, but no one other than me has been attempting to obtain it and test it.

A more detailed bullet point summary that links out to more info & citations: https://forum.humanmicrobiome.info/threads/the-fda-and-fmt-regulation-part-2-jul-2024-humanmicrobes-org-i-met-wit.520/#post-1370

Goals:

• 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.

The FDA may be more willing to budge on the GMP requirement if we're able to run a clinical trial that demonstrates safety & efficacy.

#4 is not needed if we can run clinical trials. And by itself would not be sufficient without #2. NIH could technically handle #2 on its own, but I haven't seen studies attempting it.

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Since I shortened/changed the flyers too, I'm now simply sending the flyer content:

The details are at: https://forum.humanmicrobiome.info/threads/520/post-1370.

• There's a cure for numerous diseases, including mine.
• I should be able to access this cure.
• I should not be responsible for making this cure available.
• I will never be able to access it unless someone in the federal government does something.

Part 2:
The research system needs major reform.

The details are at: https://forum.humanmicrobiome.info/threads/842/.

Major deficiencies in the research system have been preventing a treatment for numerous chronic diseases from ever being available. Hundreds of millions of dollars are being poured down the drain, and patients are being harmed.

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Current suggested solutions:

You could contact the NIH Director and HHS Secretary to discuss how this gap can be filled, since this is an important need that currently falls through the cracks.

NIH needs a mechanism to accept outside feedback, identify shortcomings, and adjust accordingly so unique projects can receive support. NIH could have a department that reviews proposals from individuals, small businesses, etc., and then creates grants for unique projects that research groups can apply for to help that individual or small business carry out their proposal.

Members of the Congressional Health Committees could sign a joint statement, along with the NIH Director and HHS Secretary, addressed to major universities and athletic organizations, such as the NBA, NFL, MLS, etc., stating that we need the player's participation to research a possible cure for numerous chronic diseases.

We need to figure out why universities didn't take on such a project a decade ago, and try to recruit all their student-athletes to see if any of them could be the source of a panacea. We need to figure out if the roadblocks are institutional, or if it's mostly lack of motivation and incentives, or even incompetence. We need to ensure the right incentives are in place for them to want to take on such a hugely beneficial project so that a patient never has to do this again; or at least, gets helped instead of hindered.

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[emilius]

https://www.humanmicrobes.org/blog/the-fda-and-fmt-regulation-part-2

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Hi Michael

I am just trying to work out how this system could work and what I understood is that FDA does issue IND and IRB approvals to their researchers. Would it be an option for HM to get that approval (following the poor FDA criteria) and then operating with stricter methods? In their article https://www.fda.gov/vaccines-blood-biologics/science-research-biologics/sars-cov-2-assay-screening-stool-donors-fmt-protocols they mention about "CBER researchers, who are reviewers that regulate FMT products" which makes me think that by following their system single donors won't be considered as drug producers? I am sure you and your team already considered this idea, I just thought it was worth mentioning.

 

[Michael Harrop]

Would it be an option for HM to get that approval

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This was covered previously in this thread. I initiated the IND process, but I do not have the resources or brain capacity to complete an IND and clinical trials on my own. My understanding is that if I was only supplying stool/donors for C. diff then I would be exempt. But I'm not interested in that. I personally need FMT for other conditions, and I want a cure for chronic disease to be widely available for other reasons as well.

 

[Otto Kretschmer]

@Michael Harrop

Have you tried contacting doctors who might help you popularize FMT? They might be more open minded than politicians and they have more authority than random people like us.

 

[SFBayFMT5]

@Michael Harrop

Have you tried contacting doctors who might help you popularize FMT? They might be more open minded than politicians and they have more authority than random people like us.

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The thing is, their hands are tied as well (in the US). Doctors and other medical professionals who promote FMT for conditions other than C. diff risk disciplinary action up to eventually losing their medical licenses if they persist. By "promote" here I mean not just to state they believe in it, what I mean is to either perform the procedure themselves or make arrangements for their patients to go elsewhere to have it done. And I believe it's similar in Canada, I remember reading a case of a practitioner who arranged trips for pediatric patients in her care to travel down to Mexico to get FMT, and when it was found out by the Canadian authorities she was ordered to stop.

 

[Michael Harrop]

I have spoken to dozens of Congresspeople at this point. I was planning on listing each individually, like before, but I don't think that would be useful right now.

For the members of the Senate Health Committee, not a single staff member passed on the information or mentioned anything about it to their Senator. This includes offices where I sent the staff a list of studies showing that FMT is a treatment for the Senator's own condition. After I went directly to the Senators on the Health Committee, some of them seemed kind and interested, but still, none of them got back to me or did anything about it. When I saw some of them for a second time, some seemed to want to avoid me, and one who was very kind previously now seemed completely different -- uneager and unenthusiastic.

This kind of about-face made me wonder if these guys are scared of the pharmaceutical industry. Perhaps that's not the reason though.

A good number of the Congresspeople I talked to definitely seem like psychopaths.

Staffers:​

One of the Senators was very nice to me and had me meet with his staff. I had previously sent his healthcare staffer all the info, and she responded with an offer to set up a staff meeting, which I consented to but then didn't hear back even after following up again. A few staffers from various offices have done this to me.

I think they may do it both as a way to dismiss persistent people, and as a way to cover their ass so they can say "Oh, we were trying to set up a meeting".

During the meeting, she asked me what FMT stood for, so it seemed clear that she didn't review the information well, which seems very common. So one of the biggest hurdles seems to be getting the staffers to actually review the information. Numerous staffers have very clearly not reviewed the info before dismissing it.

It seems like the staff don't care about your issue at all unless their Senator tells them to care. And even then, I'm doubtful the staffer even reviewed it well at that point.

We visit their office to tell them we're following up on a healthcare issue. They seem super helpful and give us the email of the healthcare staffer. But then we email them and still get no response. And when I did finally get a response from two of them, it was clear they hadn't even read it.

So the staffers at the front desk give you the impression that they're professional, competent, and care. But then for some reason, the healthcare staffers don't seem to care. I'm not sure why. It could be as simple as laziness, since it seems unlikely that anyone would find out if they're reading stuff or not.

A few of the staffers/offices completely lost the info I gave them, and that's why it wasn't reviewed.

Bernie Sanders' HELP staffer nearly convinced me that she would solve this. I almost went home after talking to her. She never followed up with me even though I did follow up with her, and she even ran into me in person multiple times over the months I've been here, and ignored me.

Research (conducted in the US itself) says that what bottom 90% of Americans want has zero influence on actual US government policies. The top 10% is much more influential

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Based on my experiences since August 2024, it seems that the reason is that the staffers usually won't even read what you send them, much less discuss it with their congressperson. So the congresspeople are kept completely in the dark about important issues.

During the RFK hearings, where chronic disease was the central topic, there wasn't a single mention of the microbiome, antibiotics, or FMT. And when I spoke to the Senators on the Health Committee, only the GI doctor and one other Senator were familiar with it.

So the staff are either incompetent, evil, overwhelmed, or there's something in their job description that is systematically preventing every single one of them from reviewing and briefing their Congressperson on the causes of chronic disease and the most promising intervention to solve the chronic disease crisis.

One of the staff's main jobs seems to be to take in information and summarize it for the senator. Many of the staff I've interacted with seem inept at this task. Many of them give really bad reasons for why they didn't discuss it with their Senator or do anything about it -- such as "You're from another state".

All this despite the fact that they are constantly holding Congressional hearings about related topics. Eg:
Wednesday, Apr 30, 2025, 10:30 AM – SD-106, Appropriations, Hearings to examine biomedical research, focusing on keeping America's edge in innovation.

Whatever the cause, this needs to be remedied, because a disabled patient should not have to drive across the country and spend months living in their car and visiting the Congressional offices each day to get someone to read and act on an extremely important issue.

John Fetterman:​

He promised to get back to me the first time I talked to him in the hall (months ago). He never did. I followed up and was able to contact him directly. I told him "If you care, there are many ways you can help with very little effort". When I saw him again a month or two later, I asked him why he didn't care. He promised again to talk to me about it. When I saw him again, he talked to me and said "None of us [in this office] are doctors", as a way to indicate that none of them felt qualified to review and vet the information I gave them. That seems insane to me.

Also, one of the Senator's healthcare staffers was an MD, and I still didn't hear back.

My Congressmen:​

Senator Alex Padilla: ​

Most Congresspeople will stop and talk to me for a few seconds. Senator Padilla would not. I told him I needed his help, he gave me the "1 moment" finger and said he'd be back. He came back an hour or more later and ignored me. I saw him again some weeks later, and he still ignored me, so I didn't bother trying to talk to him again.

Congressman Mark Takano: ​

I still haven't received a response since I first contacted them in August 2024. I've followed up via phone and email multiple times. When I visited the office in November, the staffer told me he was going to speak to Rep Takano about it in December.

I visited them again on Feb 5 and the same staffer spoke to me and basically said Mark Takano's not interested in doing anything. He chatted with me about it for 15 minutes, and clearly, there are things they can do, such as contact the agency heads, and the Health committees and their chairs, but they're just not interested.

It sounded like all they care about is stopping the Republicans, and that takes up all their time. But that's obviously a BS excuse given that they ignored me for many months before the Republicans came into office.

NIH:​

I eventually got a response from one of Senator Cassidy's staff, making it sound like it's completely up to the NIH because "the Senators don't get involved with specific treatments". Yet NIH does not allow people to protest on their campus, and there is little other way for me to bring this to their attention. A few of the letters I mailed to the physical addresses of NIH and HHS were rejected and returned.

I spoke with the new NIH Director, Dr Jay Bhattacharya. I have something to finish up in the Senate. Once I'm done, I'll try protesting outside NIH if I still haven't heard back.

I agree that this is largely up to NIH, and NIH can solve this entirely on its own. NIH can run/fund/enable the clinical trials the FDA wants, and even if the FDA approved FMT & this project, we still need funding and partnerships to conduct studies & clinical trials on clearing the existing microbiome.

 

[NiroZ]

There's a lot of expertise needed to lobby, as well as a lot of luck that the political winds favor you. You also need to be aware that they're overworked, time poor and have thousands vying for their attention. You need to have a pitch that assumes no prior knowledge that appeals to their agenda and has a compelling case. The most compelling case is that it will swing votes their way or prevent votes going against them. Showing that you have an organisation behind you help. For FMT in particular, you're going to have to help them get over the ick factor, which could make them the laughing stock of their opponents if they're not careful.

 

[Michael Harrop]

The limits of the "one-man-army":​

I talked to a Senator, and he was receptive. He had me talk to his staff about it; one of whom was a doctor. I had sent them the info twice already (via website, then direct email). I sent it to them a 3rd time prior to the meeting. During the meeting, I learned that they had not even read the basic summary info.

It appeared that the meeting was entirely useless. They didn't care at all and essentially said they ignore individuals. You must be group to get anything done. They suggested I try to recruit patient/disease advocacy groups, researchers, doctors, etc. The fact that I had already been trying to do this for the past 10 years was in the information I sent them. I said so, and asked them if they had read it. They had not.

I told them I shouldn't be having to do any of this, and the incompetence and apathy of those people and groups have been stealing my life from me, and by saying I have to convince them to help, they are helping those groups kill me.

They asked me to name an example of someone else who has done what I'm doing. I could only think of Greta Thunberg. They replied by saying she hasn't been successful. He was saying that what I'm trying to do is unprecedented and has never succeeded.

What I'm experiencing in Congress is a mirror of the exact same incompetence and apathy I've been experiencing elsewhere and trying to fix. But I seem to be stuck in a Catch-22, where the only way to get help is by making people smarter, but I can't obtain the means to do that without their help.

So based on what these guys told me, I will never be able to solve this on my own. Given that I've been unsuccessful in getting anyone to help, we may just be fucked.

You can gain all the knowledge and expertise in the world, but it's largely useless if you can't convince ignorant and apathetic people to help you.

People seem to want to take action on things that are covered in the news. Climate change is definitely widely covered in the news, which is why Greta Thunberg was able to get widespread support. But in the case of FMT, other than South Park, the media have been complicit in keeping people ignorant about an existing cure for numerous chronic diseases, and one patient's monumental efforts to make it available.

 

[Otto Kretschmer]

@Michael Harrop
Neil deGrasse Tyson (the spiritual successor of Carl Sagan) covered the gut-brain axis in a StarTalk episode a month ago, the video had 320,000 views as of now. Perhaps you could at least try to contact him?
https://www.youtube.com/watch?v=fIeVrVm1W1A