British Columbia will ask Health Canada to reconsider its guidelines to allow a Fraser Health pilot project involving fecal transplants to go ahead, provincial Health Minister Terry Lake said on Tuesday.
“People die from this [Clostridium difficile],” said Mr. Lake. “I’m a bit frustrated, to be honest, and we’ll do some work with Health Canada to see if we can get some changes.”
Fraser Health planned a pilot project that would have provided fecal transplants to patients at two Lower Mainland hospitals as soon as May. The project would have treated patients with recurrent C. difficile and donors would have been screened for blood-borne disease and other potentially harmful conditions. But the project was postponed indefinitely last Friday after Fraser Health was informed that Health Canada considers fecal therapy an experimental procedure that can only be conducted in an authorized clinical trial.
Fraser Health says it didn’t seek Health Canada approval for its pilot project because it did not expect fecal matter would be considered an experimental drug.
Neither did Mr. Lake.
“I understand the need for safeguards to be in place and proper procedures to be followed,” Mr. Lake said. “But it seemed to me [Fraser Health] were looking at this as a pilot treatment – and that as long as they had the okay from the College of Physicians and Surgeons of B.C. and it was based on good science … that they would be okay, that it wasn’t something Health Canada needs to approve.
“It’s not a device, it’s not a pill – it’s a treatment.”
Health Canada disagrees, saying fecal therapy meets the definition of a drug in the Food and Drugs Act as any substance “represented for use in the diagnosis, treatment, mitigation or prevention of disease.”
“The active ingredient is not the feces itself but rather the human microbiota contained in feces,” Health Canada spokeswoman Leslie Meerburg said Tuesday in an e-mail. “As with all new drugs, it is important to carry out clinical research under well-designed, controlled clinical trials in order to answer questions related to the safety and efficacy of a treatment.”
Health Canada would be ready to work with Fraser Health “to assist them in meeting the requirements for a clinical trial,” she added.
Fraser Health ruled out a clinical trial because of the time and expense involved and because recent studies have shown fecal transplants can be an effective way to treat C. difficile.
C. difficile infections most often occur in people who have been taking antibiotics for other conditions. When those drugs wipe out beneficial bacteria, toxin-producing C. difficile bacteria can flourish, resulting in severe diarrhea. Hyper-virulent strains have emerged in recent years and infections can be fatal.
A 2007 report by the Canadian Nosocomial Infection Surveillance Program found deaths directly or indirectly linked to C. difficile had nearly quadrupled over the preceding decade. The economic burden associated with C. difficile in Canada has been estimated at nearly $300-million a year.
As health authorities grapple with the question of how to regulate fecal transplants, some doctors are quietly providing the procedures on compassionate grounds. In the U.K., one clinic is advertising the procedure to treat a variety of conditions, including C. difficile, for a hefty fee.
That concerns Dr. Emma Allen-Vercoe, a University of Guelph researcher known for developing a synthetic stool product known as “re-poopulate.” She is currently seeking funding and doing paperwork for another clinical trial for the product.
“We know fecal transplants work – but the problem is that there is a lot of danger associated with them that people are kind of brushing over,” Dr. Allen-Vercoe said Tuesday.
Dr. Allen-Vercoe has no quarrel with using the procedure to treat older people who have recurrent C. difficile diarrhea – the target group Fraser Health was hoping to help through its pilot project.
Her concerns relate to using the procedure in younger people and for potentially different conditions.
“My problem is that if you are going to start doing this on younger people, on a broader scale,” she said. “We are so early in our knowledge of the microbial ecology of the human gut, that if we start to change things – we might alleviate some diseases, but I’m very concerned we might be setting ourselves up for a problem later on down the line.”