An international team of health researchers has found that after Canadian and Australian regulators increased their enforcement efforts on their country’s unproven stem cell industry selling purported stem cell and regenerative medicine treatments, the number of businesses selling these products on a direct-to-consumer basis declined.
Findings from their analysis, published in the journal Cell Stem Cell, showed that 60% of such businesses in Canada and Australia ceased direct-to-consumer advertising of unproven stem cell interventions.
National regulatory bodies exist to ensure that healthcare facilities and practitioners comply with applicable legal scientific standards when marketing stem cell products and other medical interventions. However, regulators have often struggled to curb the marketing of unproven stem cell treatment in a systemic and effective manner, leading to a recent influx of predatory practices in this space.
Co-author, Leigh Turner, PhD, professor of health, society, & behavior at the UC Irvine Joe C. Wen School of Population & Public Health, and his research collaborators from the University of Sydney, University of Melbourne, University of Buffalo, and RIKEN Center for Biosystems Dynamics Research, report that there are in fact effective ways of responding to nefarious marketing practices within the stem cell industry.
Over the last decade an increasing number of businesses have marketed purported stem cell products as treatments for a wide range of diseases and injuries. In the United States, for example, the number of businesses has grown from roughly 350 businesses in 2016 to 1,480 in 2021. Other countries have also seen rapid increases in companies and clinics engaged in direct-to-consumer marketing of purported stem cell treatments. Much of the expansion has been from businesses claiming benefit from using the patient’s own cells.
“Interventions marketed by these facilities have in some cases caused serious physical and financial harms to patients, while also harming efforts to conduct credible clinical research. The lack of convincing evidence that these products are safe and work as advertised is alarming,” said Turner, who is also the director of the UC Irvine Center for Health Ethics. “Regulators need to better police such markets and provide more effective safeguards for patients.”
By monitoring the online direct-to-consumer marketplaces in Canada and Australia over a five-year period, Turner and his colleagues reported on the positive effects of regulators addressing the marketing of unproven and unapproved stem cell interventions. They were able to document that 60% of businesses in these two countries ceased direct-to-consumer advertising. In 2023, only 12 businesses in Australia and three in Canada, continued to explicitly offer ‘stem cell’ treatments. In comparison, the marketplace in the U.S. has continued to expand despite increased efforts by federal and state regulators.
In Australia, the regulatory action included bringing the monitoring of stem cell products under the purview of the main national regulator, the Australian Department of Health and Aged Care, and second, reinforcing a ban on direct-to-consumer advertising of these products. In Canada, their regulator, Health Canada, affirmed its authority to regulate products using patients’ own cells by sending “cease and desist” letters to clinics offering unproven treatments.
“The actions taken by national regulators in Australia and Canada are encouraging. They suggest that targeted enforcement actions can lead to a significant decrease in the number of clinics marketing unproven stem cell interventions,” Turner said. “We don’t know whether comparable responses by regulators elsewhere might work in other countries, or if more forceful actions such as financial penalties and criminal prosecutions will be needed, but we are heartened by what we found studying regulatory responses in Canada and Australia.”
The researchers hope that their findings show that regulatory agencies can address and limit predatory marketing practices and bring troubling direct-to-consumer markets under at least some degree of control. Furthermore, efforts by regulatory agencies in Australia and Canada can provide a blueprint for other national regulators to follow by using a variety of tools to investigate and eliminate predatory marketing of unproven stem cell products and reduce the risk of patients being exposed to physical and financial harms.
Additional members of the international research collaboration include co-first authors Laertis Ikonomou from the University of Buffalo and Megan Munsie from the University of Melbourne; Carl Power from the University of Sydney; Douglas Sipp from the RIKEN Center for Biosystems Dynamics Research; and corresponding author, John E.J. Rasko from the University of Sydney.
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