From July, psychiatrists will be able to prescribe MDMA (ecstasy) and psilocybin (found in magic mushrooms) for mental health disorders.
There have long been predictions that psychedelics could “transform” psychiatry, and many clinical trials around the world have had promising results.
While some experts remain cautious about the move, psychiatrists welcomed it as a “baby step in the right direction”.
Others said that prohibition policies had delayed research into the potential benefits of such drugs, as they were painted as immoral and users were severely punished.
Australian National University associate professor, David Caldicott said that the drugs were demonised for decades as part of the “ill-conceived, ideological ‘war on drugs’”.
The Therapeutic Goods Administration’s decision will make Australia the first country in the world where medicinal psychedelics can be prescribed. What does it all mean?
What are the drugs?
Both are listed as schedule 9 (prohibited substances) but will be re-scheduled to schedule 8 (controlled drugs). That rescheduling applies only in the specific conditions mentioned, and for clinical trials, and they’ll remain as schedule 9 in all other circumstances.
Both can be considered mind-altering drugs.
MDMA (3,4-methylenedioxy-methamphetamine) is a central nervous stimulant that causes the release of dopamine, the brain chemical associated with pleasure and reward. It can give users a “euphoric rush”.
Psilocybin is a hallucinogenic, which means it can “affect all the senses, altering a person’s thinking, sense of time and emotions”.
“Psychedelics can cause a person to hallucinate, seeing or hearing things that do not exist or are distorted,” the Alcohol and Drug Foundation says.
Some mental illnesses just do not respond to existing treatments. The TGA decided there was a need for new therapies, and psilocybin and MDMA have shown promising results.
Who will get the drugs?
Psychiatrists will be able to prescribe MDMA for post-traumatic stress disorder, and psilocybin for treatment-resistant depression from 1 July.
“These are the only conditions where there is sufficient evidence for potential benefits in certain patients,” the TGA says.
Up to one in five Australians will suffer PTSD in their lifetimes, with specific groups including war veterans and emergency services workers at greater risk.
Beyond Blue estimates one in 16 Australians suffer from depression. Many of them – and possibly most – will not respond to treatment.
But not all those eligible will be able to access the medicinal psychedelics, and it is not clear how big the prescribing program will be, or will become.
Who will give the drugs?
Psychiatrists are the only ones who will be able to write the prescriptions, and even then they will need to be approved by a human research ethics committee, and then approved under the TGA’s authorised prescriber scheme.
Under the authorised prescriber scheme, medical practitioners can supply therapeutic goods that are not currently on the Australian Register of Therapeutic Goods.
A range of criteria will have to be met including how patients are selected, the protocols for delivery, the monitoring of patients, as well as criteria around training, governance and reporting.
How do they get the drugs?
For now, the only way to get the drugs is to import them, under a licence issued by the TGA, but there is a plan for a local supply.
The Australian science agency, the CSIRO, is licensed to work with psilocybin and MDMA. Dr Peter Duggan, the team leader of CSIRO’s botanical pharmaceuticals group, said the agency was working with Australian companies “to develop new psychedelic medicines and improved manufacturing processes that the companies can then use to progress their products to clinical trials and commercialise’”.
Licensed pharmaceutical companies will then be able to manufacture them here.
“The TGA’s announcement gives us optimism that the medicinal psychedelics we’re working on with Australian SMEs will eventually benefit patients,” Duggan said.
“Local companies have taken a risk in investing in the development of psychedelic drugs without existing approvals for them to be administered to patients in Australia or most OECD countries.
“The TGA’s decision shows that the pathway to full registration of certain psychedelics has begun, with more work and clinical trials to be done.”
How do they give the drugs?
Protocols will be need to be developed to guide the delivery of the medicine in conjunction with psychotherapy.
Prof Chris Langmead is the deputy director of the Neuromedicines Discovery Centre at the Monash Institute of Pharmaceutical Sciences. He says in clinical trials, there are psychotherapy sessions to prepare a patient before they have medicinal sessions – with a dose of the MDMA or psilocybin – along with psychotherapy, and with two therapists supervising.
Then there are follow up sessions.
He says it’s still not clear what the exact protocols will be for patient treatments, and that is “probably something that needs to be worked through quite quickly”.
“The psychotherapy is really the key part of this,” he says.
“The drugs, the medicines, are acting to facilitate that psychotherapy.”
What will the drugs do?
Langmead says that MDMA, when it’s used to treat PTSD, can put people in a “place of psychological ease”. “So they can go through the psychotherapy process without it being derailed by horrendous fear and flashbacks,” he says.
“[It] essentially involves getting people in a position where they can work through and relive that trauma in a safe environment. The problem is for so many, the fear comes all too quickly and rapidly.”
He says not all the properties of MDMA are yet fully understood, but that it allows patients to be open and empathic, and reduces their fear responses.
Psilocybin, which will be used for people whose depression has not responded to other treatments, works on people’s brain circuitry, and allows them to ruminate less, and to be open to new ideas.
One of the things Langmead’s team is working on is whether the psychedelic aspect of psilocybin is necessary, or whether you could develop a medicine that does something different, but without the psychedelic part.
What next?
Over the next five months, processes, protocols and training plans will be developed.
Once it’s rolled out, the data will be studied and added to the body of evidence for the drugs’ effectiveness.
And the TGA says it will consider expanding the use of psilocybin and MDMA if the evidence is there. Other areas could include anxiety, eating and addiction disorders, end-of-life stress, and obsessive compulsive disorder.
There are also trials under way for other psychedelic drugs, such as lysergic acid diethylamide (LSD) and dimethyltryptamine (DMT).
Langmead says there needs to be proper funding for the research into what happens now.
“If Australia is going to lead on this, then we really need to put the appropriate backing in, on a sovereign scale, to ensure we’re understanding the opportunity,” he says.
“These things are not a magic bullet. We need to understand which drugs might help other disorders, what the regulatory structure is for other new medicines of this type coming through.
“They’re already in clinical trials, so we need to be prepared for those to come along.”
