Australia's health watchdog has launched a national investigation into a chain of commercial clinics selling the drug ketamine as a treatment for depression.

The Australian Health Practitioners Regulation Agency (AHPRA) inquiry comes after the ABC revealed Aura Medical was offering take-home packages of syringes containing the highly restricted drug to depressed patients.

Aura Medical began spruiking the treatment direct to the public through TV and radio advertisements featuring 1980s soap star Rowena Wallace last year.

It charges over $1,000 for a course of eight ketamine injections.

Ketamine has not been approved by the Therapeutic Goods Administration (TGA) for use as a depression treatment, despite promising clinical trials showing positive short-term effects. It is used in Australia as an anaesthetic and pain killer.

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Psychiatrists have warned it is only a short-term solution, and the long-term safety of regular ketamine use has not been established.

An ABC investigation has uncovered significant links between Aura Medical and controversial erectile dysfunction company Advanced Medical Institute (AMI), along with evidence patients as young as 16 are being sold ketamine at the clinics.

Commercial ketamine clinics have sprung up across Australia and the United States in recent years, with one US medical expert describing the lack of regulation as "the Wild West of ketamine".



Doctors working for Aura Medical are legally able to offer ketamine in a practice known as off-label prescribing because the drug has been approved for use as an anaesthetic.

AHPRA is now investigating the operations of the commercial ketamine clinics and the consulting doctors working there.

Aura Medical director linked to Advanced Medical Institute

The ABC can reveal Aura Medical's director Dvora Samuel, also known as Debbie Samuel, is a long-time business associate of AMI founder Jack Vaisman and a former director of NRM Corporation, which owns AMI.

Debbie Samuel took over the NRM directorship from AMI founder Jack Vaisman for several months in 2011. ( Supplied: Facebook )

AMI, parent company NRM and AMI boss Mr Vaisman were found to have engaged in unconscionable conduct and high-pressure selling techniques while supplying sexual dysfunction medications and medical services by the Federal Court last month.

They have announced their intention to appeal the decision.

Ms Samuel, who works at Aura Medical's Sydney office, took over the NRM directorship from Mr Vaisman for several months in 2011 after the ACCC launched legal action against NRM and AMI.

Aura Medical offers ketamine injections from rooms inside the AMI erectile dysfunction clinic buildings in Sydney and Brisbane and out of a general practitioner clinic chain owned by Mr Vaisman's nephew Joe Vaisman in Melbourne.

Aura Medical's Melbourne manager Eduard Stolyarsky was also listed as the director and executive director of NRM Corporation under president, chief executive and founder Jack Vaisman on their corporate website.

The website has now been deleted.

Mr Stolyarsky, who has said he has a degree in sexology, has been involved in numerous other erectile dysfunction businesses linked to AMI and NRM Corporation including On Clinic and Impotency Anonymous.

He is also the director of a company owned by AMI which developed a "ultrasonic nebuliser" to deliver erectile dysfunction medication.

In response, Aura Medical said in a statement: "We are not aware of all these [sic] information and he is not a managing director of Aura Medical."

"There is no connection between Aura and NRM corporation.

Mr Stolyarsky says he has a degree in sexology. ( Supplied: Facebook )

"Aura Medical is subleasing some of it [sic] vacant spaces from AMI."

Company documents show Aura Medical's former director was Michael John Tattersall, who works at Australian Custom Pharmaceuticals (ACP).

ACP is a compounding pharmacy which supplies erectile dysfunction treatments to AMI.

It also supplies the ketamine to Aura Medical in vials labelled AMI Direct and bearing the ACP name and phone numbers.

In a statement Aura Medical said the AMI Direct labelling was a "clerical error at pharmacy end, we are investigating internally".

Aura Medical also said neither Jack Vaisman or his nephew received any financial benefits from Aura Medical.

Teenagers being prescribed ketamine

Doctors working for Aura Medical have been accused of not assessing patients thoroughly, not making it clear ketamine is not an approved depression treatment, and not offering alternative treatments or support.



But one mother who has spent more than $6,000 on ketamine injections for her depressed 16-year-old daughter at Aura Medical's Sydney clinic said despite concerns about the company, the results were worth the risk.

What is ketamine? A Schedule 8 prescription drug

A Schedule 8 prescription drug Used in Australia as an anaesthetic and pain killer

Used in Australia as an anaesthetic and pain killer Used illegally as a party drug for its dissociative effects

Used illegally as a party drug for its dissociative effects Ketamine has shown positive short-term impacts on depression

Ketamine has shown positive short-term impacts on depression It is not approved by the TGA for treatment of depression

It is not approved by the TGA for treatment of depression Can cause bladder and liver damage in large doses

"I knew that Aura Medical had had a lot to do with the impotency drugs," she said.

"I probably knew that they weren't the most rigorous, strictly by-the-book medical company.

"But I also knew that I was so grateful that they were actually willing to go out there and try something."

The woman, who did not want to be named to protect her daughter's identity, took home dozens of vials to inject her daughter with over the past five months.

She said the treatment had been worthwhile for the teenager.

"She's now a functioning human who leaves the house, so that's just such a gift that they've given me back," she said.

"I can see that there's some way forward, whereas before we were hopeless basically.

"She's not back to normal but for me I would have probably spent ten times that money if I knew it would make her better."

In a statement Aura Medical said medical decisions were up to consulting doctors.

"Prescribing doctors are perfectly aware that ketamine for depression is off the label use only, and as far as Aura is concerned this is explained during initial consultation by doctor," the statement read.

"It is a decision made by prescribing doctor in consultation with patient and mainly who lived [sic] very far from the nearest clinics (100 kilometres away or interstates).

"Also Aura Medical stresses in its marketing campaigns that it is only for treatment resistance [sic] depression."

Regulatory loophole allows prescription

Professor Ian Hickie from the Brain and Mind Research Institute at the University of Sydney said the potential hope ketamine brought to a vulnerable population put patients in a difficult position.

"This is fundamentally a regulatory gap in our system," he said.

"The drug is on the market for one purpose but it has crossed over into a completely different area and its use in that area is unregulated.

Legal Timeline: ACCC vs AMI December 21, 2010: ACCC launches action against AMI

December 21, 2010: ACCC launches action against AMI December 22, 2010: AMI put in Voluntary Administration

December 22, 2010: AMI put in Voluntary Administration June 14, 2011: NRM Corporation registered

June 14, 2011: NRM Corporation registered June, 2011: AMI Sold to NRM Corporation (Jack Vaisman director)

June, 2011: AMI Sold to NRM Corporation (Jack Vaisman director) August 3, 2011: Dvora Samuel replaces Vaisman as NRM director

August 3, 2011: Dvora Samuel replaces Vaisman as NRM director September 7, 2011: ACCC joins NRM to AMI court case

September 7, 2011: ACCC joins NRM to AMI court case October 5, 2011: Dvora Samuel hands directorship back to Vaisman

October 5, 2011: Dvora Samuel hands directorship back to Vaisman April 22, 2015: AMI, NRM Corporation and Jack Vaisman found guilty of unconscionable conduct

April 22, 2015: AMI, NRM Corporation and Jack Vaisman found guilty of unconscionable conduct June, 2015: AMI, NRM appeal unconscionable conduct finding

"You can understand from a patient or a family perspective the willingness to try anything to get better and pay almost anything to get better.

"But on the other side of the coin there are real risks. Ketamine has been a drug of abuse.

"It can lead to psychiatric side effects on its own. It's very unclear if it's a viable solution outside a very short acute phase."

Dozens of commercial ketamine clinics have opened in the US over the last five years, offering the treatment for depression off-label in a largely unregulated industry.

University of Pennsylvania Medical Ethicist Assistant Professor Dominic Sisti has written about the ethics of offering ketamine and urged caution.



"I'm not a naysayer, but I think we are jumping the gun in the US and definitely [from] what it sounds like in Australia as well, in terms of offering this drug wholesale to individuals who have major depression, and show up at clinics and want it," he said.

"The question is, will the efficacy wear off in time and are patients basically being hooked on this medication that really has a diminishing efficacy over time?

"I really think there needs to be some regulations put in place because right now it's the Wild West of ketamine."

While patients spend thousands of dollars on commercial ketamine clinics operating with little regulatory oversight, research institutions have been struggling to attract funding to rigorously study the long-term effects of the drug.

Psychiatrist Professor Ian Hickie said depression was a life-threatening illness and medical research infrastructure needed improvement to ensure viable treatments were quickly available to those who needed them.

"We let people down by not providing evidence quickly enough about the utility or otherwise of other treatments like ketamine," he said.

"There's a classic issue of trying to balance here patient need versus real risk."

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