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Bob Frost, 58, had been thinking about having a fecal transplant since May. The local freelance writer (who, full disclosure, has contributed to the Express) contracted C. diff in December 2012 after a minor surgical procedure required him to take antibiotics. The symptoms started with diarrhea that lasted ten days.
"I couldn't keep any food in," Frost said, adding that in the nine months he was sick with C. diff, he lost fifteen pounds.
Frost tried multiple courses of antibiotics, but the infection kept returning. "It's a beast that keeps storming back," he said. "It affects the mind and emotions, too — 90 percent of serotonin is in the gut. You worry quite a lot."
When Frost first read about fecal transplants in an online C. diff forum, he recalled thinking, "That's the grossest thing ever." But after six months of suffering, he decided he wanted to try it. That happened to be right when the FDA cracked down on the procedure, so both Stollman and Kaiser ended up denying him.
Frost said a fecal transplant would have been far cheaper compared to antibiotics — without insurance, Vancomycin runs about $1,800 for a fourteen-day treatment. That fact made him suspicious of the FDA's interference: "The FDA is in bed with conventional medicine. The drug companies won't support it because it doesn't benefit them."
Frost said he even considered doing a fecal transplant himself — there are many do-it-yourself instructions on the web — but ultimately decided against it. "There's too much potential of something going wrong," he said.
In July, when the FDA backed down on regulating fecal transplants, Frost was approved to have the treatment, but he's glad he waited; in August, his C. diff finally cleared up on its own. "It took me nine months to heal," Frost said. "With a fecal transplant, it might have taken nine days or nine hours."
Stollman said when the FDA initially announced restrictions on fecal transplants, he and his colleagues were worried that patients would attempt DIY transplants or seek treatment from the black market. But even though the FDA has eased its stance, there are still concerns about a fecal transplant black market catering to people who don't have C. diff.
"There are charlatans out there," said UC Davis Department of Microbiology and Immunology professor Jonathan Eisen, who has been researching microbial populations for twenty years and follows developments regarding fecal transplants on his blog The Tree of Life. "It appeals to scam artists. Google search for 'fecal bacteria clinic.' It's amazing how many people offer it [fecal transplants], and I don't trust many of them."
Stollman said that although there are a handful of doctors in the Bay Area who now perform the treatment, there are still not enough. "I'm still way backed up and can't keep up with demand," he wrote in an email.
The biggest barrier to patients getting treatment is doctors themselves, Stollman continued. Long before fecal transplants became the subject of media attention, almost all of his patients found him through online forums, where C. diff sufferers would commiserate and search for solutions. He called the procedure the most patient-driven treatment he's encountered in his twenty-plus years of practicing medicine. These days, Stollman said about three-quarters of his patients come to him due to their own initiative, and it often involves convincing their doctors.
In addition, the risks, amount of labor, and lack of compensation associated with fecal transplants deter doctors who might be open to performing the procedure. "There's still a whole debate about whose insurance company should be paying for the screening of the donor," Levin said. "If the donor is a Kaiser member, it's covered. Otherwise, we just handle case-by-case."
Eisen stressed that fecal transplants should not be used for conditions that are not yet proven to benefit from the treatment. Kaiser's Levin said he has performed the procedure for two patients with ulcerative colitis, an inflammatory bowel syndrome, but didn't find the results compelling enough to try again. "It didn't seem to work," Levin said. "With C. diff, it's strikingly beneficial."
Still, there are many aspects of fecal transplants that are unknown. "Infections are diverse and people themselves are incredibly diverse," Eisen said. "How do you regulate a treatment like this where everyone is so different from everyone else? We don't know how to estimate the risks. That's what we should be most concerned about."
Eisen said one person's stools can contain hundreds to thousands of different types of bacteria — most of which are unknown before a transplant takes place — meaning there could be a risk of getting an infection. So far, there have been no documented cases of such a thing happening, but long-term studies about the effects of taking on another person's bacteria don't yet exist.
As doctors wait to see how the FDA will regulate fecal transplants, they are left to speculate about the future of the procedure. Stollman and Levin believe the FDA will eventually require them to submit an IND application, which is why they've both starting filling them out. "It's been fairly laborious process," Levin said, adding that Kaiser is close to submitting its paperwork. Stollman, however, said he's not sure when his small staff will be able to complete the complicated application: "It's basically like a pharma company applying for a new drug," he said.
What is likely to change in the coming years is the donation process. Levin said he hopes regulation on how to screen donors will be enforced to ensure patients are getting healthy feces. "I think there are still some places that don't have clear policies on how donors are getting screened," he said.