A pilot project to offer potentially life-saving treatment involving fecal transplants has been halted by British Columbia’s Fraser Health Authority, partly because of uncertainty over whether human feces should be considered a drug.
Doctors were set to start offering the procedure at two hospitals as early as next month, even though Health Canada considers the treatment investigational. The treatments would have been provided to patients with recurrent Clostridium difficile infections. Donors would have been screened for blood-borne disease and other potentially threatening conditions.
But Fraser Health put its pilot project on hold indefinitely Friday after receiving Health Canada correspondence – obtained by The Globe and Mail – that said fecal therapy is an experimental therapy regulated under the Food and Drug Act.
“Since no company or individual has sought market authorizations for materials used in fecal therapy, the therapy is considered investigational, meaning that fecal therapy can only be conducted in the context of an authorized clinical trial,” Health Canada said.
That brought Fraser Health’s pilot project to a screeching halt, although the health authority hopes to regroup.
“We didn’t solicit Health Canada approval for the pilot since we did not consider faecal content would be considered an experimental drug,” Dr. Elizabeth Brodkin, Fraser Health’s medical director of infection prevention and control, said Monday in an e-mail.
“We aren’t considering a clinical trial for this procedure, as we feel there have been sufficient clinical trials to show that this treatment is safe and effective … we are fully committed to bringing this procedure to our patients in the near future as we know it can save lives.”
By classifying human feces as a drug, Health Canada is throwing up a roadblock to a procedure that an increasing number of physicians see as the best way to fight C. difficile infections, said Dr. Ed Auersperg, one of two physicians who planned to take part in the pilot project.
“How you can take stool and call it a drug, I don’t know,” he said.
Dr. Auersperg said the cancellation is deeply frustrating.
“You have no idea how disappointing it will be for people who have been having diarrhea 20 times a day for the last nine months.”
A similar debate is under way in the United States, where the Food and Drug Administration last year put fecal transplants under investigational new drug (IND) rules only to revise its stand a couple of months later to allow discretion when it came to treating patients with C. difficile diarrhea.
In a fecal transplant, feces from a healthy donor are inserted into a sick person’s system. The idea is that beneficial bacteria will crowd out toxin-producing C. difficile bacteria, which can cause diarrhea, fever, cramps, and can be fatal.
Researchers are also looking at the possibility of using fecal transplants to treat other conditions.
Fecal transplants have garnered increased attention in recent years, partly because C. difficile has become a daunting health-care problem. It is the most frequent cause of infectious diarrhea in Canadian hospitals and long-term care facilities and people who get it once are at risk of getting it again.
But official approval has not moved as quickly, partly because human feces do not fit regulators’ ideas of a “product” that can be standardized and manufactured.
Some physicians have offered the procedure without official approval. Dr. Auersperg and Dr. Jeanne Keegan-Henry, the other Fraser Health physician who was to be involved in the pilot project, had each performed one fecal transplant – Dr. Keegan-Henry in 2010 and Dr. Auersperg in 2011.
Fraser Health told the doctors to stop, as there was not an approved protocol for the procedures and they had not been approved by the College of Physicians and Surgeons of B.C.
But the health authority reconsidered last year, based largely on the results of a randomized clinical trial conducted in the Netherlands.
That trial, published in the New England Journal of Medicine, found donated feces were three to four times more effective at treating C. difficile than antibiotics.
But some researchers have called for a cautious approach.
“We rarely change treatment decisions based on one study,” Dr. Susy Hota, who is running a Health Canada-approved clinical trial through the University Health Network in Toronto.
There are differences between the Netherlands study and common medical practice in North America, she added.
The Netherlands trial included “some important information but it has some limitations in terms of affecting our treatment here [in Canada],” she said.