No safeguards: A legal loophole allows doctors to offer autologous? stem cell therapies. Photo: Phil Carrick
The national drugs regulator has been urged to clamp down on an increasing number of clinics charging desperate patients thousands of dollars for experimental stem cell treatments.
Leading medical and research organisations have backed stringent restrictions proposed to close a legal loophole that allows doctors to offer the unproven autologous? stem cell therapies, where the patient’s own cells are used. Because of this, the treatment is unregulated by the Therapeutics Goods Administration.
Patients searching for cures to life-threatening and debilitating conditions were at risk of paying huge medical bills to become research subjects without the safeguards of a regulated clinical trial, according to the Medical Council of NSW and the National Health and Medical Research Council.
But clinics providing autologous? stem cell treatments have opposed the proposed crackdown and asked the TGA to let the burgeoning industry police itself.
Reports of a growing number of doctors charging up to $10,000 for unproven autologous? stem cell therapies last year prompted the TGA to launch a public consultation to address Australia’s lax regulations of the growing practice.
Clinics marketed the unproven therapies as treatments for conditions ranging from joint pain and anti-ageing makeovers to cancer, paraplegia and autism in children.
Currently autologous? stem cell treatments administered by doctors are not regulated by the TGA because the stem cells are extracted from the patient’s own body and don’t qualify as therapeutic goods.
“Under the current system there is no requirement for monitoring or reporting adverse events. We’re completely in the dark whether these treatments have the potential to do harm or any good,” said Martin Pera at Stem Cells Australia, a consortium of stem cell researchers
In its submission to the TGA’s consultation, Stem Cells Australia warned that Australia risked become a stem cell tourism destination for overseas patients and companies seeking to take advantage of the lack of oversight.
“Compared to many jurisdictions internationally our rules are very lax and of course that will act as an invitation to particular unscrupulous operators who are in the business of making money,” Dr Pera said.
“We want to see legitimate stem cell therapies tested in humans and succeed, there is no doubt about that, but there are proper channels to do that,” he said.
The Medical Council of NSW and the NHMRC have backed the strongest possible regulations proposed by the TGA, including restricting patient access to autologous? stem cell therapies, compulsory reporting of adverse events and a ban on advertising to the public.
“There may be significant potential and possibly as yet unidentified risks to patients in an unregulated environment,” the Medical Council of NSW wrote in its submission to the TGA.
The NHMRC has also urged doctors to report fellow medical professionals over concerns that they were offering patients autologous? stem cell treatments.
But clinics currently providing the treatments have opposed any move to tighten regulations under the TGA.
The Australian Cell Therapy Society (ACTS) – a group of Australian doctors and stakeholders providing the therapies – have created a code of conduct that they hope will become the blueprint for the industry to police itself.
The NSW Stem Cell Network have backed the code of conduct, saying “it is important not to stifle innovation by putting beyond the reach of those wishing to be inventive”.
The NSW Stem Cell Network said that while was not aware of any published studies that demonstrated the effectiveness of the treatment in humans, “we are aware of a number of sports stars that appear to have benefited from receiving such cell applications,” its submission read.