Regulatory heft needed to curb false promises on stem cells, says health law expert – Innovita Research

Regulatory heft needed to curb false promises on stem cells, says health law expert

The legal and regulatory tools designed to protect the public from the marketing of unproven stem cell therapies will remain ineffective without bureaucratic will and grassroots efforts, according to a University of Alberta health law expert.

“There's this perception that stem cells are revolutionizing science and they have transformed medicine already, but that's just not the case,” said Timothy Caulfield.

“You see the word stem cells being used to sell everything from skin cream to sports recovery tools to supplements, it's absolutely everywhere.”

Caulfield, who refers to the marketing of spurious stem cell treatments as “scienceploitation,” explained there are actually only a handful of such therapies that have been approved for use in a clinical setting.

“The most well known is probably the use of stem cells in bone marrow transplants and certain kinds of leukemia—but these therapies have been around for decades,” he said, adding other stem cell therapies have shown some effectiveness in the treatment of bad burns and blindness.

“But that's it.”

What to do

In a paper outlining a strategy to combat the spread of misrepresentation within this field, Caulfield and Health Law Institute research associate Blake Murdoch argued the first step is to leverage the powers wielded by the provincial colleges of physicians and surgeons.

“We need a more robust response from them because they have the power to stop their members from marketing treatments inappropriately and from offering services that are unproven,” said Caulfield.

“We haven't seen that, and it really is their role to protect the public.”

He added organizations aimed at stopping the spread of misinformation and inaccurate marketing—like Ad Standards, Canada’s advertising industry's non-profit self-regulating body, or Competition Bureau Canada, the federal advertising regulator—can also be more involved.

“While the Competition Bureau can only prohibit clinics from using misleading advertising and

not the provision of unproven interventions, this would help to stop the spread of misinformation, which may curtail public interest,” said Caulfield.

He added political pressure on federal and provincial lawmakers could encourage change and allow a more comprehensive response, but noted that targeting the marketing of these treatments might be the more politically palatable course of action.

“I think a really good logical first step is if you're going to market this stuff, if you're going to offer these services, the information you're using to market the services has to be accurate.”

Even as the paper was being published, Caulfield said Health Canada weighed in by stating stem cell therapies need its approval.

“Basically, if you’re an MD, and you're providing stem cell therapy, you need to get it approved,” said Caulfield. “In the paper, we said Health Canada has got to get more aggressive, and thankfully, we're starting to see some action in that space.”

He said ultimately, however, responses from Canada’s regulatory bodies are often triggered by complaints from the public.

“I've actually spoken to regulators, and they’re not hearing complaints about people being injured by stem cell treatment,” said Caulfield. “Of course, just because something is safe, doesn't mean it's a good idea.”

Undermining legitimate science

Not only have some of these treatments shown to have caused real harm while offering little more than hope, Caulfield said there is a financial exploitation element, all of which can only leave a black mark on the science.

“The spread of clinics marketing these interventions may, over the long term, damage public trust in legitimate regenerative technologies, thus adversely impacting their future development,” he said. “It confuses what is an incredibly promising field.”

The most perplexing element of the proliferation of these treatments is the involvement of medical professionals who should know better, Caulfield said.

The team went into the analysis with the hypothesis that alternative practitioners were the ones providing and marketing stem cell therapies. This was true, but Caulfield said they were surprised to find that an MD was often involved.

“I've been in the room with these health providers, and you get the sense that many of them believe it works.”

Source: University of Alberta