There are links near the bottom with more info. 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.
- No single “official source” of FMT (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. This results in most clinical trials getting poor results and harming patients.
- You can’t patent a stool donor, so no pharmaceutical company is going to pursue this.
- 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, and FMT as an “unapproved drug”.
- Due to “drug export regulations”, 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.
- In Australia, the regulatory authority gathered feedback from the public prior to making their regulations. You can read at the link above 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 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 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 that no one in the research system has been able/willing to take on.
- As a disabled patient, with zero funding and resources, 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.
- The FDA’s position that “we need clinical trial proof that your donors are safe and effective” is not entirely unreasonable. The problem is that no one has been willing to fund such an endeavor.
- 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.
I contacted numerous federal legislators about this and received no response. So I drove from California to DC to protest and visit my representatives in person.
I am not willing to sit around and waste away while a simple treatment/cure exists and no one has the motivation to obtain it.
The full details are in these blogs: https://www.humanmicrobes.org/blog
Especially these two:
- The FDA and FMT regulation. Part 1. — Human Microbes
- The FDA and FMT regulation. Part 2. — Human Microbes
I argue that the chronic disease crisis deserves its own “Manhattan Project” focused on the gut microbiome and FMT. Eg: [1][2]. Because 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 as well.
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 Human Microbes 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 could also greatly benefit from help from people who are social media savvy, tech-savvy, and a marketing team/person & budget.
I should not be having to do this alone!!