Biotechs rush after authorities endorse psychedelics use
LOS ANGELES: Biotechs backed by billionaires are racing to get psychedelic therapies ready to market after Australia became only the second country to approve their use to treat depression and PTSD.
ASX-listed Emyria’s managing director, Michael Winlo, backed by Mr Forrest, said the Therapeutic Goods Administration had made a “remarkable” turnaround after it put the brakes on rescheduling psilocybin and MDMA for use in clinical settings in December.
Psychiatrists could now start prescribing the drugs as soon as July.
“The fact that they actually responded to this growing body of evidence in this positive way is remarkable,” Dr Winlo said.
Shaun Duffy, the chief executive of Reset Mind Services – a subsidiary of medicinal cannabis company Little Green Pharma, backed by Mrs Rinehart – said his company was ready to go as soon as qualified psychiatrists had been approved to prescribe the drugs.
“We already have got documented protocols for treatment-resistant depression, we’ve already got ethics approval in a clinical trial which has taken nearly two years of work,” Mr Duffy said.
“There are companies like us that are well down the track. But your suburban psychiatrist is not going to be able to just open a practice to do this. It’s going to be people within that community have already done a lot of background work in a trial environment leading up to it.”
Drug developers, academics and lobbyists in the close-knit community of psychedelic therapies were surprised the TGA’s decision on Friday.
Under the TGA decision, psychiatrists who have been approved by a human ethics committee can prescribe psilocybin for depression and MDMA for post-traumatic stress disorder, only if the conditions are long-term and have not responded to other therapies.
The drugs can also be used only as part of a longer-term psychotherapy program. The only other country in the world that has approved the use of psychedelics is Canada.
Philanthropist Peter Hunt, chairman of lobby group Mind Medicines Australia, said: “There’s no end of patients with treatment-resistant depression and PTSD that we’ve got psychiatrists already putting up their hands and saying they’ve got patients for whom this is appropriate.”
Nearly 9 per cent of Australians suffer from a chronic mental health condition, and consultant LEK Consulting said the therapies could be a major disruptor to the global $25 billion market in conventional drug treatments, which are often ineffective for many patients.
Josh Ismin from Psylo which, like Emyria, has received backing from Mr Forrest’s biotech venture capital fund Tenmile, said it “was really ambitious” to imagine that psychedelics could be prescribed as early as July.
“There will be political pressure and people pointing fingers at the TGA. It’s still going to be case by case with psychiatrists getting approval. It will take a long time for things to scale up to any sort of degree where many desperate people will have solutions available to them. It’s going to book out well in advance. But it is a step in the right direction,” Mr Ismin said.
Mr Hunt said medical grade psilocybin had already been imported from Canada and MDMA was ready to be flown here.
Psychiatrist Eli Kotler said the decision was the right one, but he harboured concerns that enthusiasm for psychedelics could get out of hand.
“A lot needs to be done to prepare the eco-system for these medication-assisted therapies before July,” Dr Kotler said.
“I also worry about the rush of people looking for a psychiatrist that can ‘cure them’ with these medicines. In truth, healing from chronic mental health conditions will always require intensive, difficult and painful psychological therapy, which these medicines can facilitate in the right person, at the right time, with the right support.
“They are not a magic panacea, or a spiritual miracle-worker or a personal messiah.”
Dr Winlo said the decision opened the door to exciting new therapies. “The potential of these drugs that operate on most of the major neurotransmitter pathways of the mind is fascinating,” he said. “These pathways are involved in mood, satisfaction, alertness and attention . . . there’ll be a range of innovation that’s now possible.”