High hopes for fecal transplant treatment for C. difficile patients

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The patient was in her 80s and racked with diarrhea, her bowels teeming with toxin-spewing Clostridium difficile bacteria.

Several rounds of antibiotics had not worked, the woman was losing weight by the day, and her doctor, Jeanne Keegan-Henry, feared she would die. So Dr. Keegan-Henry went to the drugstore, bought a blender, labelled it "not for food" and used it to mix human feces and saline into a soupy solution she administered in a procedure known as a fecal transplant.

The treatment, given like an enema or via a tube down the throat, transfers feces from a healthy person into a sick one. It is thought to work by reintroducing "good" bacteria. Health Canada considers the therapy to be in the investigative stage, meaning it must be done in a clinical trial only. Dr. Keegan-Henry's decision to use it that day in 2010 put her licence at risk.

The procedure worked as intended.

It was supposed to lead to a ground-breaking pilot project at the Fraser Health Authority that would attempt to save people who were close to death from the often untreatable C. difficile.

Instead, Fraser Health has abruptly backed off the plan to provide fecal transplants to patients at two hospitals in the region. The project was to begin this month, and donors and patients were being recruited.

But it was postponed indefinitely late on Friday afternoon after the health authority was informed by The Globe and Mail of comments from Health Canada in relation to the procedure.

"Since no company or individual has sought market authorizations for materials used in fecal therapy," Health Canada said, "the therapy is considered investigational, meaning that fecal therapy can only be conducted in the context of an authorized clinical trial."

The comments changed everything for the pilot project.

"We can't move ahead based on Health Canada's position," Fraser Health spokesman Ken Donohue said. "We will be postponing our pilot project."

The decision followed several weeks of inquiry in which The Globe and Mail interviewed the two physicians who had lobbied for the project, as well as Fraser Health's medical director of infection prevention and control. It also raises serious questions about how and why the project was approved in the first place.

Health Canada has authorized nine clinical trials involving fecal transplants across the country, but Fraser Health's pilot project was not one of them.

Elizabeth Brodkin, Fraser Health's head of infection control, said in an interview this week that Fraser Health administration threw its weight behind the idea based largely on the results of a study published last year in the New England Journal of Medicine. It found donated feces were three to four times more effective at vanquishing diarrhea-causing C. difficile bacteria than conventional antibiotics.

Dr. Brodkin said then the pilot project did not require Health Canada approval because the transplants would be offered as a health-care procedure, which falls under provincial responsibility.

It was Dr. Brodkin that cancelled the project on Friday, the health authority said, but she was not available for comment.

Fraser Health said it sought and obtained a green light from the B.C. College of Physicians and Surgeons to run the pilot project. In an e-mail, the college said it was "supportive of the health authority providing this service in a highly controlled environment."

Fraser Health had featured Dr. Keegan-Henry in its In-Focus magazine, noting her "crusade has now paid off and Fraser Health is set to provide fecal transplants at Burnaby and Ridge Meadows Hospitals after diligently working through the previous barriers."

Dr. Keegan-Henry could not be reached for comment on Friday night.

In an earlier interview, she said the procedure saves lives.

"People were dying," she said when asked what persuaded her to offer an unsanctioned procedure. "People who get C. difficile – some of them just never get better. A couple of my colleagues have had it and they have been sick for a couple of months. Antibiotics sometimes get it, but the recurrence rate is high … so when you get someone who is coming in for their third C. difficile event, you know they may well die of it.

"And people were."

The pilot project took about a year to take shape.

Part of the challenge came in trying to match a low-tech procedure with modern health-care expectations.

"For [Fraser Health] administration and the college, I get where they are coming from. They have to ensure patients get standard, modern medical therapy," said Ed Auersperg, the other physician involved in the project. "A fecal transplant is about as far as you can get to the other end of the spectrum."

Fraser Health developed a detailed protocol that covers, for example, how specimens would be collected, what equipment would be used and how rooms would be cleaned after the procedure.

Clinical trials elsewhere in the country are expected to provide more information about how the process works and the best ways to standardize it.

Susy Hota, an infectious diseases expert at the University Health Network in Toronto, is currently running a clinical trial. She said she wants to know more about how fecal transplants compare to conventional treatments. She noted that the antibiotic regime in the New England Journal of Medicine trial differs from that typically used in Canada.

In Alberta, Thomas Louie of the University of Calgary is preparing for a clinical trial that will compare results for patients who receive fecal transplants with those who take capsules containing fecal bacteria. Dr. Louie performed his first fecal transplant in 1996 and has since performed about 130.

"The procedure is advanced enough that whether you do it as a pilot or a trial – you will help patients," Dr. Louie said.