To: HHS, NIH, members of Congress
Make an existing cure (FMT) for chronic diseases available
Petition Text
- 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
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 who are healthy enough to be highly safe & effective donors are very rare.
- 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.
- You can't patent a stool donor, so it appears that everyone with money and a financial motive has decided that it's too financially risky to undertake.
- A patient analyzed the situation and took it into their own hands to work to find high-quality donors. They 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. And US experts have been saying the same thing. 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 solved this issue, and the FDA unsolved 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.
Solutions:
- We need NIH to fund/enable FMT clinical trials with high-quality donors, and test methods of clearing the existing microbiome.
- HHS/NIH needs to enable the recruitment of the few people healthy enough to qualify; either by allowing and supporting efforts like HumanMicrobes.org, or something similar.
- Congresspeople need to exercise their oversight powers to ensure that these agencies are not neglecting an existing cure for most chronic diseases. If these agencies are inadequate to address the situation, Congress needs to reform them.
Why is this important?
Chronic disease causes immense amounts of suffering. It is so widespread that people have come to accept it as normal. It is neither normal nor necessary.
Many of these conditions 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.
Existential threats like AI are much more risky under these circumstances. https://www.humanmicrobes.org/blog/stool-donors-one-in-a-million-ai-funding-potential
This is a chance to make NIH so much more cost-effective. Quote: All these different functions of the human body are regulated by the gut microbiome (See https://humanmicrobiome.info/). You're wasting time, money, and our lives, trying to figure out why thousands of streams are poisoned by individually studying each stream instead of following them upstream to the source.
Beyond the benefits of reducing the budget via less spending on Social Security Disability, Medicaid, and Medicare, chronic disease is also a huge economic loss (See previous citations).
Many of these conditions 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.
Existential threats like AI are much more risky under these circumstances. https://www.humanmicrobes.org/blog/stool-donors-one-in-a-million-ai-funding-potential
This is a chance to make NIH so much more cost-effective. Quote: All these different functions of the human body are regulated by the gut microbiome (See https://humanmicrobiome.info/). You're wasting time, money, and our lives, trying to figure out why thousands of streams are poisoned by individually studying each stream instead of following them upstream to the source.
Beyond the benefits of reducing the budget via less spending on Social Security Disability, Medicaid, and Medicare, chronic disease is also a huge economic loss (See previous citations).