The bar for becoming a stool donor just got higher

Recently, I have spent a lot of time talking to patients, trying to explain why I’ve had to cancel their upcoming fecal transplant. The FDA has ruled that stool is an investigational new drug (IND), which now imposes a huge bureaucratic hurdle to getting a much needed therapy for patients with recurrent or intractable C. difficile infection.

Even before the FDA did this, there were already hurdles for patients who are really suffering a great deal. First, there are few physicians who are providing this therapy. I have had patients drive over 8 hours to come for a treatment that is quite primitive but amazingly effective. For the doctor it’s time consuming and the reimbursement is very poor. Nonetheless, I have felt morally compelled to provide this therapy and as a result I have many thankful patients. Then there is the issue of insurance companies not covering the cost of donor testing, which costs $1,500-2,000. Now there’s the additional burden of the FDA red tape and the numerous documents required by institutional review boards.

So now I must apply for an IND number, which requires that I send the FDA my protocol. On the 30th day after receipt of my documents the FDA will let me know whether I can proceed. When I talked to the FDA officer yesterday she informed me that the FDA is only interested in fecal transplants with regards to safety. They want to ensure that donors are appropriately screened. Thus, I need to send them my protocol for donor testing and then I will get a ruling. I asked the officer what the FDA was looking for and was told that they can’t say but will either approve or not approve my protocol.

Now wouldn’t it have made more sense for the FDA to review the literature and consult experts about what optimal testing of donors and safeguards should be for the procedure and simply require practitioners to follow their guideline instead of the guess-what-I’m-thinking-and-wait-30-days game?

Ok, enough Debbie Downer. Now something positive: here’s an article about a pathology resident at Emory University, Dr. Hunter Johnson, who goes beyond the call of duty and serves as a stool donor. In the article he talks about how important it is to perform on command. I learned that lesson the hard way. When I first starting performing fecal transplants, I explained to patients the important exclusions for donor selection, such as no recent foreign travel and no recent antibiotics.

But I never thought to tell patients that choosing a donor who has problems with constipation is probably not a wise choice until the day the patient arrived for a transplant with his donor but with no stool specimen in hand. Constipation is now on my list of exclusion criteria for donors.

Michael Edmond is a professor of internal medicine and chair, division of infectious diseases, VCU Medical Center.  He blogs at Controversies in Hospital Infection Prevention.

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  • karen3

    If you do some careful digging, it appears that there is a company, well connected, that is seeking to monetize poop. That is why you are being put through this rigamarole and your patients are being denied treatment. Someone wants to make poop a for profit enterprise. Because it’s hard to find poop. Really, its in the prospectus. And the FDA is going along. Presumably because someone made a big contribution.

  • ButDoctorIHatePink

    Having had c-diff infection that caused sepsis, put me near death and almost caused the loss of my colon, after which I underwent a difficult 4 month recovery period (which, in part, cost me my job), I can certainly understand why patients would travel 8 hours or more for this treatment, and I thank you for providing it. Anything that the FDA does to impede progress in this area is cruel and inhumane. If a patient wants the treatment, a physician is willing to give it and a family member is willing to donate, the procedure should continue on until the FDA sets its stool donation criteria, whatever that may be.

    That said, people with intractable or recurrent c-diff have options for home transplants. There are instructions online, written by a physician who pioneered the transplant procedure. It would be a last resort, of course, and it sounds horrifying to a person who has never experienced this illness, but if you ever had c-diff, you know the lengths you will go to be cured. Anecdotally, the results from home transplant also seem to be good although one never knows.

    I suffered more from that disease than from anything that has happened with my metastatic cancer, including about 200 chemo sessions, a liver resection, SBRT, and several other surgeries. Fortunately, my disease retreated on its own after a few extra rounds of vanco and a slow taper, and I’ve had no signs of it for nearly a year. It terrified me so much I am always on the look-out. Now, I am a metastatic breast cancer patient who can no longer take antibiotics without the real possibility of having this disease again. It’s not a good thing to be as I’d prefer not to die in rivers of sht; and how do I treat a tooth infection?

    The real problem is not the safety of feces being donated, it is how widespread this disease is in a hospital setting and what is being done to resolve that? When I was in isolation, I still had people come in with x-ray machines that were impossible to sterilize post-use, housekeeping staff who forgot to gown up, a tech who used only alcohol to clean his hands after treating me, etc. Those spores are everywhere in hospitals and people are too busy. That needs to be addressed, and quickly, as c-diff is on the rise.

    Again, thank you for your good work. I speak for many c-diff patients you’ve treated, I’m sure. You’ve spared them from a tremendous amount of pain, suffering and embarrassment and without a doubt have saved a few lives.

  • Christine Jerelene Robinson

    Guess you didn’t think that through too well, huh?!