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Hey FDA, Poop Is Not a Drug

The views expressed are those of the author and are not necessarily those of Scientific American.


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fecal transplant

Micrograph of C. difficile bacteria Credit: CDC/Janice Carr

Imagine if in the 1960s surgeons like Christiaan Barnard or Norman Shumway had had to use the same rules that govern the development and testing of pharmaceutical medications when they were teaching the rest of the world how to transplant hearts from the recently deceased into their patients. The idea is absurd on the face of it. For starters, hearts do not come in standard sizes. Nor do all transplanted organs have the same “shelf life” the way different lots of properly manufactured drugs do.

So why does the U.S. Food and Drug Administration (FDA) regulate fecal transplants the same way that it does medications? That’s the question that Mark B. Smith, Colleen Kelly and Eric Alm ask in the current issue of Nature (which is owned by the same company as Scientific American).

Fecal transplants have become increasingly important over the past few years as a way of  basically taking the healthy gut bacteria out of one person and putting them in another person whose own gut bacteria are deficient in some way. (To learn more about this process and its benefits, check out Maryn McKenna’s article “Swapping Germs” in the December 2011 issue of Scientific American)

Instead, Smith and colleagues argue that fecal transplants should be regulated by their own set of safety rules–in much the same way that organs and other tissue products (pig valves, corneas, cartilage, blood, etc.) are.

Currently, the FDA has given fecal transplants a kind of waiver from some of the stricter rules that govern the development and testing of medications.  But that’s only as long as the treatment is used strictly for C. difficile infections, which cause debilitating gastrointestinal problems and are not otherwise easily curable. Many physicians and patients would like to know if the therapy could be made to work for other bowel problems–such as Crohn’s disease.

But the stricter FDA rules would make it harder to test fecal transplants for no good reason. Regulating fecal transplants like other tissue products would still keep patients safe, the authors argue. And it would undoubtedly keep the cost of treatment lower than would otherwise be possible if some large company with deep pockets had to undertake the sorts of tests that would need to be done to approve fecal transplants as if they were drugs. After all, if there’s something we have a lot of in this world, it’s poop.

About the Author: Christine Gorman is the editor in charge of health and medicine features for SCIENTIFIC AMERICAN. Follow on Twitter @cgorman.

The views expressed are those of the author and are not necessarily those of Scientific American.





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  1. 1. M Tucker 6:07 pm 02/19/2014

    Introducing bacteria into the gut and calling it a “transplant” is fine. Equating it to organ transplants seems silly.

    “A drug is a substance which may have medicinal, intoxicating, performance enhancing or other effects when taken or put into a human body.”

    Using that as the definition of a drug indicates to me that “transplanting” bacteria would apply.

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  2. 2. Cramer 6:30 pm 02/19/2014

    “Imagine if in the 1960s…” Also, imagine a return to patent medicine of the 1900s. Transplanting organs is a fallacious proxy. This is no more transplanting an organ than transplanting bovine insulin by syringe. At least we isolated and purified the bovine insulin rather than injecting a bovine pancreas cocktail.

    No, poop is not a drug. Drugs are single molecules that are manufactured and purified. Poop is a COCKTAIL that contains unknown components. If the science of poop was well understood, why not isolate the active ingredients (bacteria, etc). This is not about “poop” being “icky.” It’s about science and controlling uncertainties. I am sure they test each piece of “poop” for hepatitis (or the donor), but what are they not testing for? With a drug the uncertainty comes primarily from the active ingredient, not the unknown ingredients (or contaminants) that come with a COCKTAIL.

    Organ transplants are typically last-resort life and death procedures and require highly trained experts. Crohn’s is a manageable disease. Poop injections could be done at a spa (meaning: no expert required as in an organ transplant). If we don’t care about these types of uncertainties, maybe we should return to Russian roulette patent medicine.

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  3. 3. jafrates 5:46 am 02/20/2014

    Cramer, you can’t control the uncertainties associated with fecal transplants. Every single person has a different set, and even identical species will be of different strains. Even very young twins will have genetically differentiatable sets within the first few years of their lives.

    Fecal transplants can’t be managed properly under drug rules, but transplant rules may not be quite the right way to do it, either, in large part for the last-resort reasons that you mention. They should probably be subject to their own rules, or a set of rules exceptions derived from another set.

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  4. 4. KSwami 11:26 am 02/20/2014

    Interesting read. But regarding this comment:

    “And it would undoubtedly keep the cost of treatment lower than would otherwise be possible if some large company with deep pockets had to undertake the sorts of tests that would need to be done to approve fecal transplants as if they were drugs.”

    There actually is a company about to run a Phase 3 Clinical Study using FMT for recurrent C diff. here:

    http://rebiotix.com/index.php/rebiotix-clinical-program/punch-cd-phase-3-study

    I think a lot of MDs support the standardization of FMT as it takes a lot of their time to do the donor testing, preparation, and their reimbursement is also rather low.

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  5. 5. Christine Gorman 12:06 pm 02/20/2014

    Thanks for all these good, useful comments. They really help round out my admittedly short blog post and provide good leads for future coverage.

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  6. 6. MichaelKHurst 2:59 pm 02/20/2014

    Great article and interesting read. While fecal transplants are essentially limited to treating c. diff at this time, there is ongoing research for using them to treat Ulcerative Colitis. UC is similar to Crohn’s Disease but different in that ulceration is confined to the large intestine and rectum and the ulceration is not as deep, it does not extend beyond the mucous lining. For those reasons while fecal transplants can help for Crohn’s it would likely yield faster noticeable results for Ulcerative Colitis.

    Three years ago I was facing surgery to have my large intestine and rectum removed after 12 years of Ulcerative Colitis which had become treatment-resistant. A few days before surgery I discovered an article by Dr. Borody in the Journal of Gastroenterology which documented 6 cases where fecal transplants has induced longterm remission of Ulcerative Colitis which had continued for more than 5 years at the time of publication.

    Encouraged by this I ended up deciding to postpone surgery at May Clinic in Florida to give fecal transplants a try. I talked to a few doctors including one references in this article and found a healthy donor. However after a couple of months of delay I ended up doing it myself along with a combination with prescription medications including some which are not normally prescribed to treat Ulcerative Colitis.

    To make a long story short, it worked and I have continued to be symptom-free without any medications prescribed for Ulcerative Colitis since December 2011 when I finished tapering off of Mesalamine (Apriso.) Since then I have talked to many others who are seeking this out and there have been more results. I believe that for fecal transplants to have a sustained impact on Ulcerative Colitis, in many cases they may need to be continued for longer than has been done in current studies. For more information about my experience and some other explanatory articles and videos, check out my website at http://www.FecalTransplant.org

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  7. 7. rock johny 3:17 pm 02/20/2014

    M. Hurst, can you imagine the life-long hassle of not having a colon? I know a girl who had hers removed at 25 and it really tethers her to proximity to a bathroom. What a shame to think such a simple procedure could have cured her. Other articles connect obesity or thinness to a person’s gut flora. It’s not hard to reason that broad spectrum antibiotics can wreak havoc with us when it’s a fact that we harbor more bacteria cells than our own cells and depend on them for more than we know.

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  8. 8. journey93 3:46 pm 02/20/2014

    Blood seems like the best analog. It is created in the body, easily removed from the body, and easily inserted into another body w/o surgery.

    Some recent work has centrifuged samples to get only microbes, and produced enteric pills. With or w/o pills I think a bank similar to a blood bank is wise.

    The current FDA guidelines assume the fecal microbiota is a biologic, which is consistent with the “Drugs are single molecules” idea. This is likely too restrictive for practical research, and may be too kind to the pharmacy industry who makes biologics.

    Why not treat it like a blood transfusion? Testing, proper storage, sanitary administration, adverse events recorded … etc.

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  9. 9. Cramer 4:12 pm 02/20/2014

    jafrates said, “Cramer, you can’t control the uncertainties associated with fecal transplants.”

    Yes, that’s exactly my point!

    Read the last section titled “Synthetic communities” in the referenced article by Smith et al:

    http://www.nature.com/news/policy-how-to-regulate-faecal-transplants-1.14720

    Is the development of synthetic communities really that difficult? How many years away? Is there intent to mass market FMT? What is the market size (more than an orphan disease)? Why not have the goal of only marketing synthetic communities? FMT has been around for a long time (at least 50 yrs in modern medicine), why the urgent need to market it now. What are the true risks of FMT? And that’s why it’s important to have an impartial arbitrator in the loop. Hmmm, for all it weaknesses, who could that be? Otherwise let’s return to patent medicines produced by fly-by-night businesses.

    [Note: when I referred to cocktails in my previous comment, I meant cocktails with unknown ingredients.]

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  10. 10. Cramer 5:43 pm 02/20/2014

    journey93 asks, “Why not treat it like a blood transfusion?”

    Transferring infectious diseases is only one risk.

    Another risk is the effects of different microbiota.

    Proponents are NOT wanting to treat it like a blood transfusion. They are okay with the strategy of UNKNOWN microbiota fits all — not the case for blood.

    Different people have different blood (Type A, etc). We categorize blood according to that. Different people also have different microbiota and may require different microbiota for their specific condition. What’s the risk of using UNKNOWN microbiota for treating different conditions (C diff, Crohns, UC, obesity, etc)? Do we take the word of a few advocates and assume these risks are small?

    Here’s what one advocate (Lawrence Brandtsaid) said,

    “In the study we presented at the 2011 ACG meeting, we found that 4 of the 77 patients in our study developed some kind of immune disease following their fecal transplantation procedure. There was 1 case of peripheral neuropathy, 1 case of Sjögren syndrome, 1 case of rheumatoid arthritis, and 1 case of idiopathic thrombocytopenic purpura. While these adverse events bear consideration, I do not know if they were definitely attributable to fecal transplantation.”

    Yes, that’s why we need testing and oversight–to understand if these adverse events were attributable to FMT.

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  11. 11. Christine Gorman 12:13 pm 02/21/2014

    Cramer: Agree, we need testing and oversight. But there is testing and oversight with blood transfusion, cartilage implants, as well. The argument is not about whether to have testing and oversight, but rather which is the proper regulatory category to deliver testing and oversight, without unnecessarily restricting access.

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  12. 12. Cramer 2:56 pm 02/21/2014

    Christine Gorman,
    Thank you for your reply.
    I agree with you. I thought it was clear that I was saying the exact same thing as you said (meaning the ‘but…’s in your comment are a misunderstanding of my position).
    The testing and oversight for blood and cartilage primarily focuses on the transmission of infectious diseases. I didn’t mean to imply that some people want zero testing and oversight (they just appear to want it only for the purpose of infectious disease).
    Maybe an analogy (and hyperbole) is warranted here to make a point. I am no expert on the history of blood transfusion, but I’m sure before the beginning of the 20th century doctors were not concerned with blood type compatibility. Giving the wrong type of blood can result in an adverse immune system response (that appears also to be a problem with FMT). It’s almost as if people are saying ‘who cares about different blood types, let’s just do transfusions.’ In the life-and-death circumstances on Civil War battle fields (plus lack of knowledge) this is understandable. In the present-day FMT circumstance, this is irresponsible. It brings up the concern of if money, fame, prestige, altruist egotism, etc are the primary motives in wanting to side-step due diligence. It’s as if people are saying (hyperbole), “Who cares about different microbiota types; and some people might develop immune disease that might destroy their healthy vital organs.”
    Just do the research. The potential risks are more than simply the transmission of infectious disease.

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  13. 13. Peter Apps 6:47 am 02/25/2014

    How does a faecal transplant differ from a probiotic (apart from the glaringly obvious) ? Do probiotics provide any precedents for regulation ?

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  14. 14. bolonkib 4:30 pm 02/25/2014

    There is a beneficial bacteria that people with allergies lack. The lack of this bacteria is the cause of all allergies. If people with allergies ingest this bacteria, from people who have no allergies due to their possessing this bacteria, their allergies are all cured. How low can the FDA go? LOL!

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  15. 15. Satyagraha 9:00 pm 02/26/2014

    It may be beneficial to think about where our intestinal flora came from to begin with. We are born with sterile intestines. Our intestines are colonized by our mother’s vaginal and fecal bacteria, as well as bacteria in our environment. So you could say that it is a normal part of development to establish an intestinal bacteria colony from donations from other, hopefully healthy, individuals. Why transplant? Because we aren’t even close to identifying all of the strains of bacteria in healthy gut flora and like plasma, there is no mass produced product that can replace the complexity and balance of normal intestinal flora. Of course more work needs to be done, but if a patient and their doctor think this is an option they would like to pursue, I don’t think the FDA should stand in their way.

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  16. 16. MarkPine 1:11 pm 02/28/2014

    FDA is often a much more reactive organization than a pro-active one. In this case, it sounds like a company or an investigator submitted an Investigational New Drug Application (IND) or a Therapeutic Biologic Application (BLA) for stool. That’s usually done when a company is developing a product or an investigator wants to do research.

    Which way should research on stool be handled — as an IND (as a drug) or BLA (as a biologic)? (Technically, there is also a third possibility, as a medical device.) To some extent it depends on which division of the agency the company or investigator submits his application.

    In most cases it may required that the research be supervised by the government. What determines whether government supervision is required?

    That usually occurs when human volunteers are recruited by the company or the investigator to serve as research subjects. The purpose is primarily to protect the safety of the human volunteers.

    For example regulations require that all subjects must give voluntary consent to the research. They must be healthy enough to serve as research subjects. Their medical condition must be repeatedly monitored throughout the research period to ensure that they are not substantially harmed by the research and to ascertain all the adverse reactions that occur to subjects during the research period. There are other good reasons, too.

    The alternative to FDA supervision is to let research on humans go on without government protection of the subjects.

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  17. 17. hkraznodar 5:14 pm 02/28/2014

    @bolonkib – You are assuming “facts” that quite simply are not true. There is more than one kind of allergy for starters. Gut bacteria are usually good in the correct part of the digestive system but can turn deadly in the wrong part of the body. It seems to me that you were told something, probably by a complete stranger, and bought into it blindly. There are so many things wrong with your comment that it is not worthy of a LOL but instead earns a DGWIWWTP. (Dear God! What Is Wrong With This Person?)

    Link to this

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