Stem cells

Stemming the Tide of Questionable Treatments

Legal loopholes and public misconceptions are allowing unlicensed clinics to market unproven stem cell treatments. What comes next?

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Unlicensed clinics advertising “unproven” stem cell treatments for an array of medical conditions are proliferating across Canada, according to a peer-reviewed study.

University of Minnesota researcher Leigh Turner identified 30 businesses in the report, with services available at 43 clinics across the country. The marketing focus for these groups is online via direct-to-consumer ads.

Turner’s research discovered eight clinics in British Columbia, six in Alberta, three in Quebec, 24 in Ontario (17 were in the Toronto area alone), and one each for Saskatchewan and Nova Scotia.

Unapproved by Health Canada and alien to provincial healthcare plans, prospective patients need to cough up several thousand dollars to avail of these services, which come with some extraordinary claims. And all of this is legal because of a loophole that means the services offered are not regulated.

Profiteering off public misconceptions of stem cells

Ads offered treatments primarily for musculoskeletal conditions, sports-related injuries and pain relief, but at least three companies claimed to assist with everything from Crohn’s disease and Parkinson’s to erectile dysfunction, asthma and stroke.

“I’m critical of the advertising claims made by many of these companies,” says Turner. “In general, they exaggerate likelihood of therapeutic benefits and minimize possibility of complications.”

Turner commented to CTV News that it’s difficult for individual patients to navigate the world of stem cell therapeutics securely, suggesting that marketing-savvy businesses are taking advantage of desperate people.

“They just sort of set up shop and put out a shingle on the internet and start making marketing claims and begin to advertise stem cell treatments,” adds Turner.

Part of the problem may be the lack of public understanding when it comes to stem cell therapies. There is a perception – not helped by popular culture or the media – that stem cells are a kind of magic that can rapidly fix any medical problem; or at the very least, that the ability to do so is right around the corner.

A University of Alberta study found that the media has a tendency to promote an overly optimistic idea about stem cell therapies and the timeline of their availability, ignoring the huge challenges researchers face.

In the US, numerous lawsuits over dodgy treatments are ongoing and, last year, the FDA began a crackdown on the “deceitful actors” putting vulnerable people out of pocket and at further risk.

Of course, legitimate stem cell therapies do exist. Doctors use stem cells from bone marrow or blood as part of transplant procedures for patients suffering from cancer, blood disorders and other ailments. But these therapies have a strong basis in research and have received approval from the relevant regulatory bodies.

“Regulatory grey zones” facilitate growth of questionable clinics

Turner cites “regulatory grey zones” as the legal loophole through which these businesses can operate.

Canadian businesses do not need to get pre-authorization from Health Canada to market minimally manipulated autologous stem cells for homologous purposes. In plain speak, this means that businesses are free to work with stem cells taken from the patient’s own body, so long as they don’t modify them significantly and the purpose is similar to that of their original function.

Ultimately, there is no rigorous clinical process required to prove the efficacy of these treatments.

“We need Health Canada to do more than it’s done to date to try and address this sort of marketplace,” says Turner.

“If I were to develop a regulatory framework, it would be one where you have to go through a careful clinical trial process, you have to gather safety data, you have to gather efficacy data and you need to convince independent parties that you’ve got a true treatment.”

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Barry is a journalist, editor, and marketer for several media outlets including HeadStuff, The Media Editor, and Buttonmasher Magazine. He earned his Master of the Arts in Journalism from Dublin City University in 2017 and moved to Toronto to pursue a career in the media. Barry is passionate about communicating and debating culture, science, and politics and their collective global impact.