Activists relieved but wary to learn B.C. naturopath ending pricey fecal transplants for autism

A B.C. naturopath who charges families thousands of dollars to give autistic children pills and enemas made from human feces says he is ending that operation, prompting feelings of tentative relief from activists who've spent years pushing for him to stop.

Jason Klop says he plans to shift his business from providing these unproven treatments which have been the subject of numerous complaints to exclusively manufacturing fecal microbiota transplants (FMT). He says he will only sell these capsules to be used for their one authorized purpose: treating C. difficile infections that haven't responded to other therapies.

But Klop has not explained how he plans to do that when he is currently banned from producing and marketing FMT by his professional college.

That's not the only barrier, either. Health Canada says it has already rejected one licence application to produce FMT at Klop's Chilliwack facility, citing a long list of quality control and sanitation problems.

Advocates for autisticchildren are greeting the news of Klop's corporate pivot with mixed emotions.

"I'm excited that it's at least going to stop," said Melissa Eaton, a North Carolina mother of an autistic child who tracks potentially dangerous and unproven treatments by infiltrating private Facebook groups, and is responsible for bringing Klop's business to the public's attention.

"Part of me thinks great, this isn't going to be happening to children, but it still seems like he's not been punished for what he's done," she told CBC News.

Anne Borden, an autistic activist in Toronto who has also been tracking Klop for years, said she's not sure how to feel.

"I'm a little skeptical. The entire business model isn't stopping," she said.

'No evidence' of proper quality control

As CBC first reported in January 2020, Klop has been charging parents about $15,000 US for autistic children as young as two years old to receive FMT, mainly at a clinic in the Mexican oceanside city of Rosarito. He has since expanded to offer his services in Hungary, Australia and Panama.

FMT treatments involve taking bacteria and other microbes from the poop of a healthy person and transferring them to a patient either anally or orally, with the goal of restoring a normal environment inside the gut.

Although it is currently the subject of research for a wide array of potential uses, FMT is only approved in Canada and the U.S. for the treatment of recurrent C. difficile infection.

Doctors and scientists have warned that any other use of this emerging therapy is experimental and carries serious risk of infection, while people with autism have denounced Klop's procedure as an unproven treatment that puts vulnerable children in danger.

Klop's business, Novel Biome, has been the subject of a number of complaints to both the College of Naturopathic Physicians of B.C. and Health Canada. That includes one from a former employee who alleged he was producing FMT capsules using his nephews' stool in a basement apartment in Abbotsford.

So far, these complaints have resulted in an "extraordinary action" preventing him from making and selling FMT products while he is under college investigation, a warning from the college that he appears to be operating outside his scope of practice, and enforcement actions from Health Canada that includea restriction from accepting Canadian children on his international "retreats."

Those trips abroad will end in August, Novel Biome's director of medical communications, Shaina Cahill, confirmed in an email.

"Novel Biome has made the decision to focus exclusively on FMT product manufacturing to provide safe and high-quality FMT products to support hospitals, clinics, researchers, and physicians for approved conditions and clinical research," Cahill wrote.

She touted Novel Biome's "state-of-the-art microbiota laboratory, stringent donor screening and rigorous internal standard operating procedures" designed to produce "consistent, effective, and safe FMT products."

Neither Cahill nor Klop responded to follow-up questions about how he plans to operate an FMT business while still under a regulatory ban that has been upheld by two levels of B.C. courts.

But Cahill said the company is working on obtaining a drug establishment licence (DEL) from Health Canada to produce and sell FMT.

A Health Canada spokesperson confirmed that Novel Biome has already applied for a licence once, but the application was rejected after an inspection in February turned up a list of 16 problems with the company's facilities.

That includes issues with cleaning and sanitation, an unqualified employee supervising the manufacturing process, poor record-keeping practices and "no evidence of a functioning and/or independent quality control department," according to a public report card from the inspection.

"Novel Biome is welcome to reapply for a DEL, once the site is able to demonstrate compliance," the Health Canada spokesperson wrote in an email.

The email also noted that the federal agency is currently investigating a new complaint against Klop and his company, but the spokesperson did not provide details.

'The problem just grows'

When asked about Klop's business plans, the naturopath college's deputy registrar, Lee Dorner, said he could not comment because of the confidentiality provisions of the Health Professions Act.

However, Dorner confirmed that Klop remains a fully licensed naturopath in B.C.

Both Eaton and Borden say they want to see governments take a more proactive approach to dubious treatments targeting children, including better regulation of how they are marketed through social media.

"When I first uncovered what [Klop] was doing, it was only in Mexico. He's operating in several other countries now," Eaton said.

"We see when nothing's done immediately about it, the problem just grows."

Borden urges parents to carefully consider their autistic children's well-being and mental health before subjecting them to unproven treatments.

"It's not just about a future that someone on the internet is promising that you're going to have if you use their product. Really, your child's well-being is about the connection you have now. It's about the quality of life that you have now," she said.