No one knows how many people have undergone fecal transplants—the official term is fecal microbiota transplantation, or FMT—but the number is thought to be at least ten thousand and climbing rapidly. New research suggests that the microbes in our guts—and, consequently, in our stool—may play a role in conditions ranging from autoimmune disorders to allergies and obesity, and reports of recoveries by patients who, with or without the help of doctors, have received these bacteria-rich infusions have spurred demand for the procedure. A year and a half ago, a few dozen physicians in the United States offered FMT. Today, hundreds do, and OpenBiome, a nonprofit stool bank founded last year by graduate students at M.I.T., ships more than fifty specimens each week to hospitals in thirty-six states. The Cleveland Clinic named fecal transplantation one of the top ten medical innovations for 2014, and biotech companies are competing to put stool-based therapies through clinical trials and onto the market. In medicine, at any rate, human excrement has become a precious commodity. (...)
Scattered case reports in the medical literature described
C. difficile patients, some on their deathbeds, who received fecal transplants and recovered, often within hours. Then, in January, 2013,
The New England Journal of Medicine published the results of the first randomized controlled trial involving FMT, comparing the therapy to treatment with vancomycin for patients with recurrent disease. The trial was ended early when doctors realized that it would be unethical to continue: fewer than a third of the patients given vancomycin recovered, compared with ninety-four per cent of those who underwent fecal transplants—the vast majority after a single treatment. A glowing editorial accompanying the article declared that the trial’s significance “goes far beyond the treatment of recurrent or severe
C. difficile” and predicted a spate of research into the benefits of fecal transplants for other diseases.
“Nothing in health care works ninety per cent of the time,” Mark B. Smith, a microbiologist at M.I.T. who is a co-founder of OpenBiome, the stool bank, told me. Zain Kassam, a gastroenterologist who is OpenBiome’s chief medical officer, put it this way: “It’s the closest thing to a miracle I’ve seen in medicine.” (...)
Among the desperately ill, FMT’s reputation as a wonder cure has outstripped the science supporting its use. The lure of a potential remedy that is widely available, inexpensive, and considered relatively low-risk has yielded an improvisational approach to treatment and a growing D.I.Y. transplant population. When Jon Ritter agreed to serve as a donor for Tom Gravel, the Greenwich Village Crohn’s patient, Gravel paid the charges for the blood and stool screening that Ritter’s insurance didn’t cover. But these tests can cost hundreds of dollars, and many patients are circumventing the medical system altogether. On YouTube, FMT how-to videos have received thousands of views, and on Facebook there are private forums where people trade advice about the procedure. “There are a lot of people who are doing this at home,” Lawrence Brandt, of the Montefiore Medical Center, says. “Some of them are doing it under the instructions of their physicians. Some of them are doing it by reading the Internet.” One of his patients, ill with
C. difficile and unable to find a donor, asked whether she could use her dog’s feces. (The answer was no.) Another placed an ad in her local paper; more than forty-five people responded. Instances of FMT going terribly wrong are hard to find, although there have been anecdotal reports of people developing bacterial and viral infections following the procedure.
Like Mark Smith, of OpenBiome, the F.D.A. watched the surging demand for fecal transplants with concern. In the early nineteen-eighties, at least twenty thousand people became infected with H.I.V. after receiving blood transfusions contaminated with the virus, because doctors didn’t know to screen for it. Could a similar, as yet unknown threat be lurking in a donor’s stool? In May, 2013, agency officials convened a public workshop on FMT in Bethesda, where they explained that the F.D.A. considers stool to be a drug. This wasn’t particularly surprising. The agency defines a drug as any material that is intended for “use in the diagnosis, cure, mitigation, treatment, or prevention of disease.” An exception has been written into law for body parts, including skin, bone, and cartilage, which are classified as tissue. But the statute excludes most human secretions from this category.
Substances labelled drugs are subject to a rigorous approval process. Pharmaceutical companies typically spend many years and millions of dollars researching and testing a drug before submitting it to the agency for approval. Until the F.D.A. approved a fecal-transplant therapy, the procedure would be considered experimental. In order to offer it to patients, doctors would need to file an investigational new-drug application, or I.N.D., and obtain the agency’s permission. “That hit the whole field like a ton of bricks,” Smith, who attended the workshop, told me. “There was this increasing momentum around fecal transplants, and all of a sudden the whole field hit the brakes.”
I.N.D.s are intended to capture every aspect of a prospective therapy in exacting detail. At the Bethesda workshop, one gastroenterologist said that it had taken her hundreds of hours to complete the paperwork. Many others lacked the resources and staff to devote to such a task. “What do we do with the fifteen thousand patients who are really desperate for something that works?” a doctor from the Mayo Clinic asked F.D.A. officials. “If your mother shows up with severe or recurrent
C. difficile, are you going to not offer something that you know how to do safely, effectively, and say, ‘I can’t do it because the regulatory agencies in the United States have decided that this requires a special licensure’?”
Image: Oliver Munday
A 46-year-old mother of three, Dooley is the cofounder and president of Julie’s Baked Goods, a purveyor of cannabis-infused snacks. She has celiac disease and wanted to create gluten-free products that would relieve her pain without damaging her intestine. Dooley’s Denver company released its first product, granola mixed with cranberries and almonds, in 2010 and now sells about 6,000 units a month, employing 11 people.
