Catherine Duff, a fifty-seven-year old Indiana grandma with a compromised immune system, drove up to the security gates of the National Institute of Health in Bethesda, Maryland. She was greeted by four armed guards, two of them holding dogs on leashes. She was asked to get out of the car and proceed into a booth where she went through what she describes as “the strictest security check I’ve ever been to in my life.” She was patted down and asked to hand her belongings to the personnel. “They don’t just look at your purse; they take everything out,” she recalls. When she was finally let out of the booth, she found the doors of her Chevrolet Tahoe open and a canine sniffing through the glove compartment. Guards guided mirrors underneath the car, checking for explosives. For the shy, timid person Catherine Duff was, the process seemed very intense. “The only thing they didn’t ask for was a DNA sample,” she says. “It was a bit intimidating!”
Half an hour later, armed with a badge that allowed her to enter the NIH campus, she headed to the Lister Hill Center auditorium. As she browsed the registration sheet, she found her first surprise. Out of 150 participants in this public workshop, she was the only member of the public. Everyone was a doctor, a researcher or an affiliate of the CDC, FDA or other institutions, while her badge boasted neither Ph.D. nor MD. Catherine felt out of place — and intimidated again. Most attendees sported formal attire — women wore business suits, men sported suits and ties. She wore a skirt and a black cardigan. Some participants greeted each other like old friends; she didn’t know anyone. The auditorium’s first few rows, outfitted with microphones and outlets for laptops, were reserved for featured speakers, so she settled in the bleachers and took out her iPad to take notes on fecal updates.
The Food and Drug Administration was hosting a public workshop with a peculiar name: Fecal Microbiota for Transplantation. Over those two days in May 2013, doctors and policymakers from the FDA and Centers for Disease Control would discuss the risks and benefits of transplanting human feces to treat Clostridium difficile, commonly known as C. diff, an intestinal infection that claims 14,000 lives a year in America alone. Catherine knew the horrors of the illness firsthand. She had been confined to her house for weeks, having to use the bathroom every two hours, and was bedridden for months, fatigued from not being able to absorb nutrients from food. “You can get renal failure or cardiac arrest because you get so dehydrated from diarrhea,” she says. “And at one point I was in renal failure.” After a friend found her unconscious in her house, she was rushed to the emergency room and spent three days in the hospital. These severe dehydration incidents left a permanent mark — Catherine’s kidney function had decreased.
During its sixth reoccurrence the infection became antibiotic-resistant, rendering the standard Western medicine useless. Catherine read on the Internet that some C. diff sufferers cured themselves with fecal transplants — in layman’s terms, putting healthy people’s excrement up their butts.
None of the doctors she saw could stomach the idea of transplanting human waste, so she and her husband did it themselves with a plastic enema, a blender and a cheese cloth, following a procedure they found on the web. Their homebrew killed off the superbug, and Catherine founded The Fecal Transplant Foundation to educate other C. diff patients about the simplest and cheapest of all remedies: poop.
Catherine believed the FDA’s workshop meant that this unconventional treatment was becoming a mainstream medical practice that would cure thousands of people. She was both anxious and excited. She anticipated talking to other C. diff survivors and looked forward to learning how her new foundation could help connect patients with transplant providers.
Instead, she learned that the procedure that saved her life was itself in danger.
After the first few presentations, she realized that the handful of doctors in the country who performed the transplant were about to get their hands tied. As word about the therapy’s success spread, the FDA was faced with the necessity to regulate it. The agency was going to label the fecal transplant an “investigational new drug,” or IND. Every doctor who wanted to perform it would have to file an IND application and get the FDA’s approval.
“The process of doing that sounds very logical but is extremely arduous,” says Alexander Khoruts, a gastroenterologist at the University of Minnesota, and a workshop attendee. An early pioneer of the transplant, he had an IND approved before the FDA decided to make it mandatory. “I put that application on the scale just to weigh it — it weighed twenty-two pounds. It had to be packaged in several boxes and took us a year to complete.” The “us” was a university team of ten researchers. So a single practitioner would never get it done alone. And no single patient could wait that long. “To treat an occasional patient with this procedure, you’re not going to fill out an application that size,” he says. “It basically meant: FDA shuts it down for most people.”
Catherine Duff didn’t know the IND application itself weighed more than her baby grandson, but she understood the outcomes. She wanted to speak up, but had been mortally afraid of public speaking her whole life. In high school, presenting an oral book report filled her with dread. At work, speaking in front of a small group of colleagues gave her panic attacks. And what would she tell all these experts? Why would they listen to her?
“I was horrified and I didn’t know what to do,” she recalls. “But I knew that the new policy meant more people were going to die.”
All because they didn’t have access to a shot of healthy stool.
One morning in April 2012, John Duff, Catherine’s husband, then fifty-seven years old, became a stool donor. In his home bathroom, he delivered his donation into a white container that came in a vacuum-sealed plastic bag. In medical lingo, the device was called a “hat,” and it looked like one too — its white brims kept it on the toilet sides while the specimen was being deposited into its basin.
John brought the hat downstairs to the kitchen and set to work. He poured boiling water over his homespun toolkit — blender, funnel and cheese cloth. He emptied the saline solution from the enema bottle into the blender and transferred the hat’s content into it. After the mix danced inside the glass, fusing into dark-brown goo, he sieved it through the cheese cloth stretched over the funnel and pureed the remaining globs into mush so they wouldn’t clog the enema’s nozzle.
The brew looked like a chocolate milkshake. It smelled like anything but.
None of it fazed John, though. A former submarine officer, he was long accustomed to the odors of human excrement. When a submarine waste tank is emptied, the contents are expelled under pressure, but the air used to create that pressure is then sucked back onboard because there’s only so much of it in an underwater vessel. That recycled air brings smells with it, smells that waft through the sub more than once a day.
John doesn’t remember if he used gloves to sieve his shake. If he wasn’t mashing it with his bare hands it was to keep the fecal cocktail germ-free. “It wasn’t to prevent the sample from getting on my hands, but to prevent my hands from getting on the sample,” he says. When he was done, he screwed on the enema’s top and carried it upstairs to his wife.
If there was ever a seasoned patient, Catherine was it. In her mid-thirties she suffered a freak horseback-riding accident — she fell off a horse and the horse fell on top of her, breaking her left leg in twelve places. When her leg healed, it became shorter than the other, causing a chronic limp, which over the years would wear out the cartilage in her hips and knees. Later in life, Catherine developed diverticulitis, an inflammatory intestinal disease in which little pouches swell inside the colon. After surgery, she contracted her first C. diff infection. As more intestinal, hip, knee and other surgeries followed, C. diff kept returning, leaving her bedridden for months at a time. It eventually stopped responding to Vancomycin, the antibiotic of last resort, and Catherine realized that she might not live. Her only other option was a colostomy — replacing her entire colon with a plastic bag, essentially an intestine outside the body. “Every time you go to the bathroom, it comes out of the bag,” says Catherine, who had a temporary colostomy after her abdominal surgery. “You can’t go anywhere because you don’t know when the bag is going to make noises or leak.”
Compared to that, a fecal transplant felt like a breath of fresh air. If it worked, that is.
It was Catherine’s daughter who first read about the transplant on the Internet, but the only two doctors they found practicing it at that point were in Nevada and Australia, and Catherine was too sick to travel. “For the three months she didn’t go downstairs, except when she had to go see a doctor,” John recalls. “I brought meals to her and we ate in bed.” Catherine’s gastroenterologist wouldn’t do the transplant himself, but agreed to write a prescription for John to screen his stool for pathogens and disease. John passed the test — his excrement was healthy.
The DIY procedure suggested elevating the bed’s foot to make the transplant flow up the intestines. So John had brought up a six-by-six piece of lumber from his garage and propped the bed’s end on it. Catherine rolled over on her left side, her knee pulled up towards her chest — the recommended position. “We weren’t nervous,” John recalls. “We wanted to move on.” When he was done, Catherine turned onto her back and lifted her legs up, slowly turning her body from side to side to spread the mix inside her.
John sealed his toolkit in a hazardous waste disposal bag, and they both waited for the matter to work its magic.
If there was one terrible, yucky, pathogen-laden thing your mom yelled at you to never touch, it was poop. So how did this archetype of brewing disease become a life-saving potion?
“There was a very successful paradigm in modern medicine that viewed microbes as pathogens,” Khoruts, the gastroenterologist, says. “That paradigm is not completely accurate because the majority of microbes in our body are beneficial.” We were apparently looking at feces all wrong — at least for the past couple of hundred years.
According to the Human Microbiome Project, microbes live in and on our body in such abundance that their cells outnumber ours by about ten to one. Many live on our skin or in our mouth, but the vast majority reside in our gut, helping us absorb nutrients in our food — about ten percent of our calories come from microbial digestion. But the microscopic creatures also form complex ecosystems that keep pathogens at bay. When their population takes a hit after an antibiotic treatment, invaders like C. diff can move in. Killing C. diff takes even more powerful antibiotics that damage the intestinal flora so badly they actually pave the way for the bug to return. After such “carpet bombing,” as Khoruts calls it, “all the normal stuff is gone.”
The efficacy rate of the transplant is ninety-eight percent, Khoruts estimates, and there are several hypotheses why it works. One is that C. diff may be native to the human gut, so replacing the missing flora restores the balance. Another idea, to which Khoruts assigns more credibility, is that there’s an active microbial warfare being waged inside our bellies. Different bacteria produce different compounds that have antibiotic qualities and kill off other species. “There are antibiotics being made by our own bacteria,” Khoruts explains — some of them have been identified and are being studied. “They are not like our compounds that carpet bomb everything; they very narrowly target C. diff.” The third idea is that microbes talk to our immune system, stimulating its response. “When you put animals or people on antibiotics, that microbiota decreases,” Khoruts says. “So the immune system is less active in fighting any infection.”
The transplant also looks promising in treating other intestinal maladies such as Crohn’s Disease and Irritable Bowel Syndrome. But some researchers posit that if a donor has diabetes or cardiovascular disease, which can be related to microbiota, the recipient may inherit them. In cases of life-threatening C. diff, the transplant’s benefits do outweigh the risks, but medics agree the transplant use should be regulated so that “it wouldn’t be a Wild West out there,” according to workshop attendee Colleen Kelly, a gastroenterologist from The Warren Alpert Medical School at Brown University. No one wants quacks to sell stool panaceas on the web. “There’s a reason why we humans don’t eat fecal material; there’s a reason why evolution made sure it looks disgusting to us,” Khoruts says.
And yet, poop potions are far from novel. Doctors in ancient China used different recipes, says Liping Zhao, director of the Laboratory of Molecular Microbial Ecology and Ecogenomics at the School of Life Sciences and Biotechnology at Shanghai Jiao Tong University. One involved placing a hollow bamboo stick into an outhouse pit for the winter and later drying the material accumulated inside into a powder form, to be taken by mouth. Another one prescribed putting babies’ offerings in a jar and burying it in the soil for three years. And the most elaborate recipe called for mixing a healthy adult’s poo with clay and burying the jar for ten years so it would turn into an odorless, clear-yellow viscous liquid known as “golden juice.” In all three methods, the fecal matter was kept in aerobic conditions to stay pathogen-free while the native gut bacteria would breed, becoming medicinal. “They were fascinating production methods,” Khoruts says. “It would be very interesting to know what they came up with.” Zhao points out that these techniques aren’t officially practiced in China today, but that some traditional doctors may still do it. He says there have been reports of a Buddhist monastery that still cooks up the golden juice. “Buddhist monks have a very healthy intestinal flora, so they collect and bury their fecal matter every year,” Zhao says. “And every year they dig some out and give it to people for free.”
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“The only thing it really cost us was the blender,” John says. On comparison, one year, Vancomycin cost Catherine’s insurer over $200,000.
The procedure’s instructions recommended keeping the transplant inside for as long as one could, and Catherine lasted for four hours. When she finally went to the bathroom, she felt different. Something inside her had changed. For the first time in months, she slept through the night with no bathroom trips due to diarrhea. “When I woke up I felt good enough to take a shower and dry my hair and put on make-up and jewelry — things I hadn’t done in months!” she recalls. “Within two days she was driving a car,” John says.
But in July 2012, she had to have a back surgery, and C. diff returned. By that time, her colorectal surgeon, encouraged by her story, did the fecal transplant via colonoscopy, and began offering it to his patients. But Catherine wanted to see more doctors perform the procedure and more lives saved. She kept thinking of all the people who never heard about this unconventional option and didn’t know enough to Google it. “I had Internet access, financial resources and family support, and it was still the hardest thing in the world to learn about how to do it,” she says. “I promised myself that if I lived, I was going to do something to make it easier for people to find out about fecal transplants and find a doctor to do it.”
In early 2013, she started building the Fecal Transplant Foundation, aimed at connecting patients and doctors, and encouraging healthy individuals to donate their curative droppings to stool banks. One of her daughters, a lawyer, asked her firm to help her mother start the non-profit.
Four months later, the new FDA rules were about to flush her efforts down the toilet.
“I was scared and I was mad,” Catherine says, describing her emotional state during the workshop’s second day. “Not angry — mad! And really scared.” What riled her up was that some presenters harped on the transplant’s potential future dangers — what if recipients inherit the donors’ diabetes or heart disease? To Catherine, who a year ago wasn’t sure she’d live another week, these diseases sounded manageable and treatable. But C. diff still defied modern medicine. “I decided I would speak,” she says, “for all those people who would be affected by the new IND rules.”
Forgoing lunch, she typed a short speech during the break and told the panel moderator she wanted her voice heard. She felt intimidated — the moderator, a six-foot-tall man in a suit, towered over her petite frame. “You can ask a question during the panel,” he counter-proposed. “No, I am the only patient here and I have to speak,” she objected and burst out crying, overwhelmed by the gamut of emotions — fear, anger, anxiety. Taken aback by her tears, the moderator relented. “O.K., O.K., you can speak,” he said, instructing her to sit in the microphone row and raise her hand after the panel’s second speaker.
Catherine didn’t hear anything the next two speakers said. She was a nervous wreck. She was afraid of slurring words, of forgetting thoughts, of even losing the text of her speech on her iPad. “I was having a panic attack,” she says. At the panel, Kelly, the gastroenterologist from Brown, talked about the efficacy of the transplant in her study. Jay Slater, director of FDA’s Division of Bacterial, Parasitic and Allergenic Products, re-emphasized the reasons necessitating the IND. The moderator lost his glasses on his head, and the audience cracked up.
And then, just like that, it was Catherine’s turn. “It’s now or never” dashed through her head as she got up. Her microphone switched on and the panelists gazed up at her. Her heart pounded in her chest. She felt like she was going to pass out or throw up. But her fear of not speaking was greater than her fear of speaking.
“I seem to be the only actual member of the public that’s here at the public forum,” she began. “I’m one of those people who call and email you every day…” As she went on to recount her story, describing her desperation and the newfound hope, the emotions took over and she again broke into tears. “If your spouse, child, parent, sibling or best friend were dying from antibiotic resistant C. diff, I imagine that all of you would want them to be able to try
FMT,” she said ardently. “People are dying every day, today, right now. I have a wonderful husband, three amazing daughters and two small grandchildren, and I want to live. All of us just want a chance to live. Please, do something not only for me, but for all those around the country and everywhere who have no insurance, no financial resources, no computer with which to Google information, and no hope. Please do something quickly.”
She finished and stood there, her face wet from tears. From the panel down below, Slater motioned to her to look around and she realized she was not the only one crying. Other attendees were teary-eyed too. So were some of the panelists. “There was a moment that was very moving,” Khoruts recalls. “There was a brief moment of silence and then the whole audience burst in applause.”
And then, as Catherine puts it, “all hell broke loose.” The meeting’s structured official tone was gone. “People were standing up and talking, and raising their hands and talking, and people were talking to each other in the audience, and asking specific questions of the people on the panel,” she recalls. Khoruts describes it as a “heated discussion” in which the medics were pressing the agency for an interim solution. “We don’t have three years to wait and there are a lot of patients like the one who just spoke,” said Bob Orenstein from the Mayo Clinic.
“How are we going to help these patients while studies are going on?” Johan Bakken from University of Minnesota echoed.
“We don’t have a clinical team to go out and do all these trials, but we have saved lives,” stated Sarah McClanahan from Thomas Memorial Hospital. “How long is it going to take to get something back from the FDA that says we can continue saving people’s lives?”
The discussion went over time, until the electricity in the auditorium shut off. “They were saying we have to leave,” Catherine says, but people lined up to introduce themselves to her in the darkened room, lit only by the dim emergency lights on the floor. “They were thanking me for speaking and asking how they can help and asking to keep in touch.” It was at about that time Slater came over too. “I just want to thank you for coming today,” he said as he shook her hand. “How old are your grandchildren?”
“They are two years and six months,” she answered, and then added, “Please take into consideration what I said.”
“We will,” Slater replied.
Two months later, Kelly, who by that time was on Catherine’s foundation board of advisers, emailed her the new ruling: The FDA would not enforce the IND to treat C. diff patients who were not responding to antibiotics.
“While we believe in the Investigational New Drug (IND) process, we did not want the IND process or our requirements to delay this therapy for the really ill patients who need it,” Slater explains, adding that the FDA had made similar exceptions before, such as for certain umbilical cord blood products. “The progress of the science will determine the long-term solutions to C. diff infections.”
Catherine’s speech helped her launch the foundation; many of the doctors she met joined her board of advisors and connected her with other transplant advocates. “The foundation has grown amazingly fast since then,” she says. It now collaborates with many organizations, from the CDC to the Human Microbiome Project, and will continue advocating for patients and the science of microbiota transplantation.
Much of the medical community hopes the treatment will be fully approved in a few years. Mark Davis, a naturopathic doctor in Portland, Oregon, and an advisor to Catherine’s foundation, thinks it stands a better chance of being approved as a tissue rather than a drug — akin to blood transfusions. But another promising form is pills, or “crapsules” as some people call them. Thomas Louie, a Professor of Microbiology and Infectious Diseases at the University of Calgary in Canada, has been treating his C. diff patients with encapsulated bacteria extracted from people’s stool. And Elaine Petrof at Queen’s University in Kingston, Canada, is experimenting with RePOOPulate, a synthetic stool mixture that mimics the gut microbiota, sans any diseases a human donor may have. Going oral may be a more natural way than up your butt. “The way we acquire our gut flora is through our mouth,” says Kelly, explaining that bacteria travel through the intestinal tract and settle where they belong.
At the FDA workshop, Dr. Mayur Ramesh from the National Center for Emerging and Zoonotic Infectious Diseases likened the transplant to kefir — to him, both were nothing else but potent probiotics, albeit ingested differently. So maybe one day synthetic fecal drinks may wind up in our refrigerators. Maybe they will come in different flavors and look like milkshakes, only with a better smell than John Duff’s. Maybe marketing minds will dub them “shitshakes.” And then we will finally catch up with the Chinese doctors’ wisdom of centuries ago: taking the curative crap by mouth, whether powder or juice. Only instead of burying it for ten years, we’ll mass-produce it in regulated factory-size synthetic guts, putting all fecal matters to rest.
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Laurel Lynn Leake works in all sorts of mediums to explore how we construct and communicate our identities in an intersectional world. Leake graduated from the Center For Cartoon Studies and lives in Vermont.
To read our Storyteller Spotlight interview with Lina Zeldovich, click here.