Health Canada is sticking to its position that fecal therapy – commonly referred to as fecal transplants – comes with significant risks of disease transmission and should be restricted to clinical trials.
Those concerns are outlined in a memorandum prepared for Health Canada officials and obtained by The Globe and Mail under the Access to Information Act.
"In the case of fecal therapy, there is a growing body of evidence, including data from some clinical trials, which suggests that it may be a very effective treatment for recurrent C. difficile," states the memorandum, which was prepared for federal officials before a planned telephone conversation with B.C.'s deputy minister of health, Stephen Brown.
"However, as with other drugs derived from human sources including blood for transfusion, there is a potential risk of transmission of an infectious disease from the donor to the patient, especially in patients with weakened immunity," the memo states.
"In the media," it adds, "Health Canada is receiving criticism regarding its position that [fecal therapy] meets the definition of a drug subject to the Food and Drugs Act."
The province confirms the B.C. deputy minister spoke with Health Canada on May 1, 2014. That conversation followed a story in The Globe about a Fraser Health Authority pilot project that would have made fecal therapy available at two hospitals in the Lower Mainland, increasing access to a procedure that is not widely available through the health-care system, although do-it-yourself tutorials are popping up online.
Health Canada says fecal therapy falls under the the Food and Drugs Act's definition of a drug: "any substance represented for use in the diagnosis, treatment, mitigation or prevention of disease."
Fraser Health put the pilot project on hold after learning of Health Canada's position that fecal therapy is an investigational procedure that must be studied in clinical trials.
Physician Jeanne Keegan-Henry, now retired, who backed the Fraser Health pilot project, says there is more than enough evidence to justify providing fecal therapy, including a trial reported in the New England Journal of Medicine in 2013 that found donor feces significantly more effective than antibiotics in treating recurrent C. difficile.
"If you look worldwide at the literature, the risks of infection [from fecal therapy] appear to be very close to zero," Dr. Keegan-Henry said. "The risks of staying in hospital because you are sick for another six weeks are nowhere near zero."
Fecal therapy involves putting the processed feces of a healthy person into the gut of a sick person to get rid of disease-causing bugs. Some of the ways of administering it include enema, colonoscopy and nasal tube. The concept is not new – one oft-cited early reference from a fourth-century Chinese medical text recommends using "yellow soup" to treat diarrhea – but has gained attention in recent years for its success in treating C. difficile, which causes diarrhea, pain, fever and can be deadly.
Health Canada has authorized nine clinical trial applications, including three for C. difficile infection, the memo says, adding that it "would welcome the opportunity to work with researchers from the Fraser Health Authority to assist them in meeting the requirements of a [clinical trial application]."
It can take years to design and get approval for a clinical trial, Dr. Keegan-Henry said, adding that the costs of fecal therapy are far lower than repeated treatments with antibiotics.
People can carry C. difficile without getting sick. People are infected by touching surfaces contaminated with feces and then touching their mouths. People who are ill, elderly or on antibiotics are at greater risk.
B.C. reported 2,378 cases of C. difficile infection in 2014, down 26.7 per cent from the previous year and the lowest number reported since the province started tracking the illness in 2010, according to a report by the Provincial Infection Control Network of B.C.
Of those cases, 70.6 per cent were classified as "healthcare-associated:" infections picked up in hospitals or other facilities.
A memo prepared for the deputy minister and associate deputy minister to brief them ahead of a conversation with B.C. health ministry officials, prepared in April 2014 Read the full story here.