Michael Harrop
Active member
Since my first letters in 2018 to both the NIH and FDA, nothing has changed. Tens of millions of dollars continue to be wasted on FMT clinical trials with low-quality donors, patients continue to be harmed, and safe & effective FMT continues to be unavailable, and neither the NIH nor FDA seems to care. The researchers conducting the trials certainly do not care and have no interest in using better donors even though a patient did all the work for them and screened over a million people to find better donors. I still get nothing but silence when I write to researchers about the donor quality issue.
All this despite the fact that I'm likely the #1 world expert on FMT. You have a disabled, home-ridden patient with no funding or support outperforming the entire world's research system, and the people in that system have zero interest in the matter, and the regulatory and funding schemes not only do not support the patient but prevent them from continuing.
I want to say enough is enough, I'm going to war against these incompetent, apathetic people who are stealing my life from me. But what am I supposed to do? NIH doesn't even allow people to protest. And virtually the entire patient community for all chronic diseases are completely apathetic, and would rather sit around and moan about their situation while refusing to do anything to improve it.
I'll continue to lobby Congress to reform this extremely flawed system, but so far, it seems like most congressional offices/staffers don't care either.
It is so egregious that it has gone on for this long. Whoever is approving funding for FMT clinical trials, needs to review my work, discoveries, and complaints. They need to understand the donor-quality situation. They need to understand that the criteria for a safe and effective donor has likely already been found by a patient and is being ignored by the people running the clinical trials, and thus the people running the clinical trials continue to harm patients and prevent a likely cure from becoming available to us.
You need to stop approvingfunding for FMT clinical trials that do not make a genuine effort to address the donor quality aspect.
I have written directly to the NIH Director (Monica M. Bertagnolli, M.D.) and HHS Secretary (Xavier Becerra) about this, and will now be submitting this to the NIH and HHS Offices for Human Research Protections.
In all my interactions with the FDA, they seem responsive, receptive, courteous, and professional. But I think their decisions and actions in regards to regulating FMT, antibiotics, and clinical trials, are so flawed and harmful. I've continued to send them evidence and arguments. One of their worst policies is making one of the most irrelevant criteria (GMP) the main hurdle/focus instead of the most important one, by far, donor quality.
If my donors are making people worse, people are going to stop ordering from me and I'd go out of business (assuming proper informed consent and public tracking of results). They're going to say "His donors are bad, he doesn't know what he's doing or is unable to obtain good donors; don't buy from him". Whereas researchers can be as incompetent and apathetic as they want, waste hundreds of millions of dollars of public funding, use whatever low-quality donors that are the easiest for them to obtain, make people worse, and no one bats an eye. They still get paid, continue to get paid, continue to get funded by the NIH and approved by the FDA, and get automatic trust and respect from everyone other than me, and nothing changes.
Publicly funded researchers are overwhelmingly acting like mindless, incompetent, apathetic robots that don't care about patient outcomes. Thus, they need to be treated like such. You shouldn't be trusting them to design and run their own trials. Instead, they should only be trusted to carry out the robotic aspects of someone else's protocol. This appears to be what they've been trained to do, and thus all they're capable of.
So for example, I submit a proposal to the NIH of what I'm trying to accomplish, and why, and the NIH then creates a grant that any research group can apply for to help me carry out my protocol.
I should not be having to do this alone, and even worse now, not at all. I should not be having to spend the winter in my car in D.C. trying to get someone to fix this. I need a team, and the research system needs major reform.
All this despite the fact that I'm likely the #1 world expert on FMT. You have a disabled, home-ridden patient with no funding or support outperforming the entire world's research system, and the people in that system have zero interest in the matter, and the regulatory and funding schemes not only do not support the patient but prevent them from continuing.
I want to say enough is enough, I'm going to war against these incompetent, apathetic people who are stealing my life from me. But what am I supposed to do? NIH doesn't even allow people to protest. And virtually the entire patient community for all chronic diseases are completely apathetic, and would rather sit around and moan about their situation while refusing to do anything to improve it.
I'll continue to lobby Congress to reform this extremely flawed system, but so far, it seems like most congressional offices/staffers don't care either.
It is so egregious that it has gone on for this long. Whoever is approving funding for FMT clinical trials, needs to review my work, discoveries, and complaints. They need to understand the donor-quality situation. They need to understand that the criteria for a safe and effective donor has likely already been found by a patient and is being ignored by the people running the clinical trials, and thus the people running the clinical trials continue to harm patients and prevent a likely cure from becoming available to us.
You need to stop approving
I have written directly to the NIH Director (Monica M. Bertagnolli, M.D.) and HHS Secretary (Xavier Becerra) about this, and will now be submitting this to the NIH and HHS Offices for Human Research Protections.
In all my interactions with the FDA, they seem responsive, receptive, courteous, and professional. But I think their decisions and actions in regards to regulating FMT, antibiotics, and clinical trials, are so flawed and harmful. I've continued to send them evidence and arguments. One of their worst policies is making one of the most irrelevant criteria (GMP) the main hurdle/focus instead of the most important one, by far, donor quality.
Relevant links:
- Summary of the current situation: https://forum.humanmicrobiome.info/threads/the-fda-and-fmt-regulation-part-2-jul-2024-humanmicrobes-org-i-met-wit.520/#post-1370
- History of advocacy: https://forum.humanmicrobiome.info/forums/fecal-microbiota-transplant-fmt/?prefix_id=71
- The incompetence of the research system https://forum.humanmicrobiome.info/threads/the-fda-and-fmt-regulation-part-2-jul-2024-humanmicrobes-org-i-met-wit.520/post-1443
- My work screening a million donors: https://www.humanmicrobes.org/blog
- Donor quality information https://forum.humanmicrobiome.info/threads/donor-quality-and-stool-type-hypothesis-for-fmt-fecal-microbiota-trans.142/
- My FMT roadmap https://maximiliankohler.blogspot.com/2019/12/fmt-roadmap-proposal.html
- FMT failures https://forum.humanmicrobiome.info/tags/fmt-failure/
- Harm to patients https://forum.humanmicrobiome.info/tags/poor-fmt-outcome/
- What I learned from doing FMT myself https://forum.humanmicrobiome.info/threads/my-detailed-experiences-lessons-from-13-different-fmt-donors-jun-2018.53/
- Widespread incompetence and apathy among "professionals" https://maximiliankohler.blogspot.com/2021/06/idiocracy-part-1-scientists-in.html
- Many more https://forum.humanmicrobiome.info/forums/microbiome-studies-articles/?prefix_id=6
Private vs public:
If my donors are making people worse, people are going to stop ordering from me and I'd go out of business (assuming proper informed consent and public tracking of results). They're going to say "His donors are bad, he doesn't know what he's doing or is unable to obtain good donors; don't buy from him". Whereas researchers can be as incompetent and apathetic as they want, waste hundreds of millions of dollars of public funding, use whatever low-quality donors that are the easiest for them to obtain, make people worse, and no one bats an eye. They still get paid, continue to get paid, continue to get funded by the NIH and approved by the FDA, and get automatic trust and respect from everyone other than me, and nothing changes.
Publicly funded researchers are overwhelmingly acting like mindless, incompetent, apathetic robots that don't care about patient outcomes. Thus, they need to be treated like such. You shouldn't be trusting them to design and run their own trials. Instead, they should only be trusted to carry out the robotic aspects of someone else's protocol. This appears to be what they've been trained to do, and thus all they're capable of.
So for example, I submit a proposal to the NIH of what I'm trying to accomplish, and why, and the NIH then creates a grant that any research group can apply for to help me carry out my protocol.
I should not be having to do this alone, and even worse now, not at all. I should not be having to spend the winter in my car in D.C. trying to get someone to fix this. I need a team, and the research system needs major reform.
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