TGA calls for comment on stem cell options


Australia’s medicines watchdog has taken an important step towards potentially closing a loophole that has allowed a plethora of so called stem cell clinics to provide unproven treatments without any regulatory framework or accountability.

And one of the country’s leading stem cell experts has called on physicians to make their thoughts known on the subject.

“This is a step in the right direction,” clinical haematologist and pathologist Professor John Rasko told the limbic. “It is the next step towards a regulatory framework that is long overdue.

“We need to shut down these shonky clinics, not just because they are unsafe but because they don’t work.”

The Therapeutic Goods Administration (TGA) has released a revised Consultation Paper on the regulation of autologous stem cell therapies and is seeking submissions from interested parties.

This follows the release of the first draft of the consultation paper in January 2015, which attracted 80 submissions.

The TGA is now seeking comments from interested parties on the revised options that address the issues raised by stakeholders in response to this paper.

Professor John Rasko, Professor of Medicine at the University of Sydney, head of the Cell and Molecular Therapies department at the Royal Prince Alfred Hospital, and president-elect of the International Society for Cellular Therapy, said autologous stem cell therapies had been allowed to run riot due to the lack of regulation.

He said providers of the controversial therapy were able to exploit this loophole and target patients who were vulnerable and desperate to try anything at any cost that holds even a remote promise of improving their condition.

This includes the use of autologous stem cell transplants to supposedly treat osteoarthritis and other joint problems, treat migraines, as cosmetic treatments and even to supposedly improve the condition of people who have Alzheimer’s or have had a stroke.

Professor Rasko said he had even heard about lumbar punctures being used to inject stem cells, and there was a general belief that many of these procedures were being undertaken without adequate informed consent.

“The very idea that you could perform a lumbar puncture to inject the cells in the hope of achieving benefit, shocks me to my bone,” he said.

“You don’t know what doctors are doing behind closed doors and because of the loophole it’s under-regulated.”

He said regulators needed to move decisively to close the loophole that allows these procedures to go ahead.

The current loophole – the TGA’s excluded goods orders – allows for the use of human cells and tissues when they are “taken from a patient and used under the supervision of a medical practitioner who is caring for that patient for a single indication in a single course of treatment.”

The use of stem cell procedures in patients with osteoarthritis has been a hot topic since the release last month of a NSW coroner’s damning inquest findings into the death of a dementia patient who underwent an unproven liposuction stem-cell procedure.

“The TGA is not the only regulatory authority that has fallen short here,” he said. “The ACCC and AHPRA haven’t really stepped up either.

“We all have to subscribe to randomised controlled clinical trials to demonstrate safety and efficacy, why should cellular therapies be any different? Let’s just say these cells worked. You would find me equally yelling from the treetops please make these available. But they don’t work based on our current evidence.”

The TGA consultation paper puts forward four options for consideration, including:

Option 1 – is essentially the status quo (with a minor modification to extend to dental practitioners).

Option 2 – maintains existing exclusion for products (with a minor modification to extend to dental practitioners) provided the products are not advertised direct-to-consumers.

Option 3 – maintains existing exclusion for products (with a minor modification to extend to dental practitioners) provided the products are not advertised directly to consumers and not more than minimally manipulated, but introduces a new and increased intermediate level of regulation for products that involve more than minimal manipulation reflecting the level of potential risk.

Option 4 – maintains existing exclusion for products (with a minor modification to extend to dental practitioners) provided the products are not advertised directly to consumers and not more than minimally manipulated.

Professor Rasko said he hoped people would make submissions to the TGA.

“I hope that submissions resoundingly agree that doing nothing so as to leave the loophole open is not a reasonable option,” he said.

“Option four seems to me to be the most rational reaction to closing the loophole. Why should we be lowering the bar in regulation?”

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