FDA to Ban Stool Banks?

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FDA to ban fecal transplant donor banks

In May last year the US FDA declared Fecal Microbiota Transplant an Investigative New Drug and confined its use to patients with Clostridium Difficile whose condition had not responded to other treatments. It has now issued a draft guidance paper proposing that stool banks be banned in the US. Patients will be limited to using stool from donors known to them, and tested by their treating doctor.

This is disturbing news for the FMT community due to the difficulties encountered by most in sourcing a suitable donor. However the good news is that the FDA is seeking comment on its proposal. This means that you can have your say by clicking “Comment” in the right hand corner of the FDA Paper.  If you’ve had trouble finding a donor please take the time to send a comment to the FDA and tell them why. All it takes to make a difference is a two sentence comment that says:

“Stool banks are required because it’s so difficult to find a donor.”  Then outline the difficulty you have experienced eg:

  • willing donor tested unsuitable
  • suitable donor was unwilling
  • suitable donors live too far away
  • can’t afford the testing
  • don’t know anyone willing or able

Please don’t write an emotional tirade to the FDA as that won’t help. Regardless of the frustration we feel as a community, we need to respect that the FDA have a job to do and have asked for comment.  Below is my submission to the FDA on behalf of PoP. Please feel free to paraphrase any points that resonate. Comments must be sent before March 28, 2014.

 

My Comment to the FDA

I am the editor of thepowerofpoop.com, which is a FMT patient information and advocacy website. I also run the FMT Facebook group. I am Australian based, however my website attracts an international following with 65% of visitors being from the US.

The number of US visitors to my site doubled after the FDA decision last year to restrict FMT access and has not declined since. Every day I direct US patients to the research on FMT, correct their many false assumptions (including that it’s a miracle cure for every ailment on the planet), discourage them from unsafe practices (like using animal feces or shipping feces in the mail), urge them to have their donors tested and above all, to discuss FMT with their doctors. Unfortunately patient discussions with doctors often don’t go well as many doctors need to be educated by their patients about a) the research on FMT; b) guidance available from the AGA; and c) the availability of a donor bank to supply the microbiota. Many patients encounter dismissal and even ridicule from their doctors and end up doing home FMT. I am concerned that one day someone will do home FMT the wrong way and end up perforating their colon or catching a blood or fecal borne illness.

I believe banning stool banks is a retrograde step that will simply drive more patients underground to DIY home FMT. Prohibition never works. The reality is that finding a suitable donor in a world where people defecate daily is not as easy as you might think. A donor has to be willing, able and available. Issues encountered by patients include:

  1. Many donors are unsuitable. According to the Van Nood study, two out of three donors tested unsuitable.
  2. The cost of testing is prohibitive, so it isn’t practical to test multiple donors. 
  3. Donors known to the recipient may withhold risk factors in their screening questionnaire (promiscuity, IV drug use etc).
  4. Many potential donors are deterred by the embarrassment factor and don’t appreciate how serious an invisible illness like C diff can be.
  5. Sick people simply aren’t well enough to ‘sell’ the FMT proposition to their loved ones, who at best have to be educated and at worst cajoled into donation.
  6. Chronically ill people suffer social isolation and often have few people left in their life. When those few test unsuitable, they are out of options.
  7. The donor needs to live locally as fresh is best, and the sample needs to be delivered quickly. This restricts choice.
  8. One of the biggest deterrents to doctors/hospitals providing FMT is preparation of the fecal matter. They don’t like it and nor do their staff. It’s much easier to simply call a stool bank and have it delivered. As it is, patients spend their time educating and begging doctors to do FMT. To expect doctors or their staff to cheerfully don a mask and put feces in a blender is a deal-breaker.

The above reasons combine to make it very difficult to do FMT without a donor bank and explain why it’s not practical to leave stool-sourcing to the patient and their doctor. If that happens, one of two things will occur: more people will do home FMT and/or more people will die.

In contrast to the issues listed above, the stool bank model has the following advantages:

  • Suitable equipment to freeze the microbiota, overcoming the timing and geographic constraints of fresh donations.
  • A double safeguard built in due to the incubation period.
  • The donors are anonymous thereby precluding the chance that risk factors will be withheld.
  • The use of regular donors gradually develops a proven group of donors, thereby exposing patients as a demographic to less risk over time.

Given the choice, I would use a stool bank like OpenBiome over a known-donor every time. Wouldn’t you?

Lastly, I would like to mention the issue of commercialization of fecal microbiota. The sooner we have microbiota capsules on sale by prescription at a drugstore, the better. However there are risks in confining the distribution of fecal microbiota to those who wish to patent a cocktail of microbiota and profit from it. Donor banks with real microbiota from real people, as opposed to microbiota bred in a lab, will provide a valuable control group against which to measure the success of commercial alternatives.

In conclusion, I ask you to consider the above factors and risks of home FMT before making your decision about stool banks. There’s not one patient who visits my site who wouldn’t prefer to have their FMT done through a doctor and stool bank, than take a risk with DIY and the unproven stool of a loved one.

It’s very easy to distance yourselves from the misery of the individuals involved, and the desperation that drives people like us online in search of cure. But I ask you to consider what you would do if you were defecating the entire contents of your body all day long, knew you were slowly dying and encountered all the obstacles listed above in trying to find a donor to do FMT. What would you do?

 

To send your comment to the FDA, click “Comment” in the right hand corner of this link.

 

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7 replies »

  1. I am looking forward to the day when we the people ban the FDA.

  2. Thank you for the thoughtful post on this topic and for sending your thoughts to the FDA. Are there other companies besides OpenBiome that are banking stool?

  3. OpenBiome is the only independent stool bank however some clinics have teams of regular donors and supplies of frozen FMT that would also be affected by this decision.

  4. The FDA should be told that FMT has been used for years by vets in treating large animals for gastric disorders. My vet has used it to cure foals of diarrhea for decades. It is not a new or novel idea.

    So please, don’t outlaw FMT. Why can’t they keep track of sample just like blood banks do?

    http://www.voanews.com/content/fecal-transplants-used-to-cure-intestinal-disorders/1723974.html

  5. As a Clinical Microbiology laboratory supervisor, I need for Transplant banks to be available as a resource.

    I do not want to prepare the product in my laboratory because the nature of the process will aerosolize fecal bacteria in the very area where I am preparing and plating other clinical samples.
    1) I have very large concerns that making hospitals perform their own preparations instead of allowing us to purchase pre-screened samples from a stool bank will lead to false-positive cross contaminated cultures which could lead to unecessary treatment of patients. In this day and age of needed antimicrobial stewardship, unecessary antibiotic treatment has the potential to further expose a patient to antibiotic resistance. I do hope the CDC is weighing in with the FDA on this issue.
    2) It is a fact that most clinical microbiology biological safety cabinets (BSCs) do not have UV light sterilizers. Therefore, there is no way for most laboratories to adequately disinfect their BSCs adequately enough to counteract the aerosolization.

    3) I do not want to take my laboratory staff away from doing important patient work to perform stool concentrations for which the laboratory cannot charge because it is not yet FDA regulated.

    4) From a hospital infection control perspective, preparation in the lab can lead to contamination that will falsely elevate Nosocomial Infection markers leading the CMS to withold essential funds for hospitals.

    5) I have been told by infectious disease and gastrointestinal physicians that some patients simply do not have any time left and need to be transplanted within 24 hours. While clinical labs can screen for some infectious agents during this time, we cannot screen everything for which we need. To do that will take 7-14 days for all of the results to come back. So,what will happen is that each facility will be forced to create their own, secret, stool donor storage. Now I ask the FDA, which is easier for you to regulate, a handful of nationally held stool banks or a bunch of secretive hospital lab stool banks all doing something different?

    6) Finally, I have collegues who have told me of patients with CDT that are often alientated from their families. Because of this, there needs to be an independant alternative to the family/friend donors especially when so many of those friends/family dononrs are unsuitable.

  6. Nancy, thank you for your thoughtful comments, please submit them to the FDA via the link provided or if it has expired, by writing to them directly.

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