Last week the Therapeutic Goods Administration announced its interim decision not to reschedule medical grade psilocybin and MDMA for medical use, but Mind Medicine Australia is going to contest the decision.
The announcement has temporarily derailed plans to use these substances to treat mental illnesses including depression, PTSD and substance abuse in Australia.
MMA claim the proposed therapies have been achieving outstanding remission rates in overseas trials, are being used in expanded access schemes in the United States, Canada, Switzerland and Israel and have been shown to be safe and non-addictive when used in medically controlled environments (e.g. hospitals and clinics).
The rescheduling applications were lodged last July and supported by over 80 leading psychiatrists, psychologists, pharmacologists, researchers and other medical practitioners.
Comment on interim decisions
The Chairman of Mind Medicine Australia, Mr Peter Hunt AM, said, ‘Whilst we are disappointed, we have to remember that these are only interim decisions. The enormous benefit that we now have is that the Secretary of the Department of Health has had to publish his reasons for making these interim decisions.
‘Under the rescheduling process we now have the opportunity to address each of those stated reasons in our final submissions.
‘We believe that the reasons given by the Secretary to justify his interim decisions contain a number of significant errors and omissions and we will be working hard over the next few weeks to draw these to his attention in our final submissions. In the absence of evidence many of the statements amount to nothing more than prejudice.’
Prejudices of the past in play?
MMA Board member and Executive Director of the Ethics Centre, Dr Simon Longstaff AO, said ‘We should not allow the prejudices of the past to deny relief in the present.
‘If these medicines are safe and effective when applied in a clinical environment, as current research suggests, then Australian governments have an obligation to make them available.’
The MMA said that the responses given to the TGA about their rescheduling submissions were overwhelmingly supportive, and included positive responses from world-leading psychiatrists, psychologists, pharmacologists, researchers and other scientists.
Nothing else is working
Executive Director of Mind Medicine Australia, Tania de Jong AM, said, ‘We live in a country with some of the worst mental health statistics in the world and where an enormous number of people are suffering with treatment resistant conditions.
‘Nothing else is working for them. It is time to give all Australians, who live with multiple failed attempts at recovery, the opportunity to access treatments that will improve and save lives,’ she said.
‘As a registered charity we owe it to all of those people who are suffering to overcome prejudice and stigma.
‘We need to do everything that we can to highlight that these medicines can be used safely in medically controlled environments, and therefore should be controlled medicines under the Australian Government’s Poisons Standard.
‘All the research indicates that the medicines are safe and non-addictive when administered within a medically-controlled environment. There have been no adverse events in over 150 trials globally,’ said Tania de Jong.
The final date for second round submissions is Thursday 4 March 2021, and the final notice of the TGA will be given on 22 April 2021.