They tout themselves as “centres of excellence” staffed by “stem cell doctors”- a medical specialty that does not exist.
Their websites feature patient testimonials – banned under AHPRA’s advertising laws – and cite published research by authors who appear to be unaffiliated.
These and other “questionable” promotional strategies used to sell unproven autologous stem cell therapies are now laid bare by new research that puts the spotlight on the marketing tactics of 70 Australian stem cell clinics.
According to lead researcher Associate Professor Megan Munsie from Stem Cells Australia, a lax regulatory environment – which allows these treatments to be sold without having to go through clinical trials to prove they are safe and effective – has enabled the market to flourish, with 54 clinics in Australia now selling stem cell injections for everything from arthritis to gastroenterological disease, diabetes and neurological conditions.
A further 16 clinics offer stem cell injections for cosmetic use only.
Of particular concern is the way the industry uses scientific “tokens of legitimacy” to attempt to authenticate what are currently unproven therapies, say Professor Munsie and colleagues in their paper published this month in Regenerative Medicine.
Clinicians are often presented as “Stem Cell Doctors” and “Stem Cell Specialists” – a medical specialty that the authors point out is not officially recognised.
Some describe themselves as “centres of excellence” – a term usually reserved for nationally recognised and government-funded centres of clinical and research expertise.
And a number of the clinic websites reference published literature as a way of reinforcing claims of safety and efficacy, sometimes citing the scientific and clinical potential of autologous stem cells using different cell sources or techniques the clinics themselves do not offer.
Many of these authors do “not appear to have any association with the clinic” and only two clinics cite their own research – published case reports.
Then there are the clinical trials.
Two clinics promote their involvement in trials, including details about placement on the public clinical trials register.
But the authors note these clinics sell the same treatments that are being trialled.
“It seems clear than many clinics are promoting their support for, and participation in research in order to establish their scientific and clinical credentials and in so doing sell their products and services,” the authors claim.
“The promotion of research that has yet to be registered or approved, the conduct of tightly controlled clinical trials while at the same time offering the same therapies for the same indication at substantial cost and the use of single site ‘registries’ as clinical research all point to the use of research as a marketing strategy to establish authority and credibility where none exists.”
At the centre lie concerns about public harm, the authors conclude, noting how three women in the US were left blind after stem cell treatments offered in what they believed was a clinical trial.
“Unless addressed, these practices risk harming not only vulnerable patients but also undermining public trust in science and medicine”.
Since the paper was finalised, the TGA has proposed to tighten regulation of the manufacture and clinical use of autologous stem cells using a multi-tiered system based on risk.
The toughest rules would apply to autologous stem cell provided outside a hospital setting, but treatments manufactured and provided in a hospital by a doctor or dentist for a patient in their care will remain unregulated.
Under the proposal direct-to-consumer advertising would be banned, however services “that that “don’t mention specific products” could still be advertised.
Professor Munsie, deputy director of stem cell systems at the University of Melbourne, told the limbic the changes announced in October are welcome, but it remains to be seen how much impact they will have on the industry.
“The things that concern us are around advertising and how that will be changed and enforced and the delineation between product and services,” Professor Munsie said.
“Many clinics we identified could quickly change to be purely offering services….we are worried that would be another loophole.”
The changes announced by the TGA will mean greater oversight for private clinics but not “accredited” hospitals, and Professor Munsie said question marks remain about the interpretation of that rule.
“So it’s a bit of a watching brief at the moment, but it’s moving in right direction.”