Citing scientific and humanitarian grounds, Mind Medicine Australia is urging the Therapeutic Goods Administration to reverse its interim decision to block the legal availability of psilocybin and MDMA as controlled medicines.
The original rescheduling applications were lodged last July, and supported by over 80 leading psychiatrists, psychologists, pharmacologists, researchers and other medical practitioners, plus 30 leading scientists and clinicians from DrugScience UK.
Regarding the interim decision, the Chairman of Mind Medicine Australia, Peter Hunt AM, said, Under the rescheduling process we have now had the opportunity to address each of the reasons provided by the TGA in our final submissions.
‘We recognise that part of the problem that the Delegate has faced are the views of risk-averse peak bodies that have not properly analysed the safety and efficacy of these therapies within a medically controlled environment. We deal directly with this failure in our submission.’
MMA’s Executive Director Tania de Jong AM said, ‘We hope that the Delegate will put aside the politics of fifty years ago which has caused so much mistrust and focus on the data and science that will save lives.’
Mind Medicine Australia says there is now plenty of evidence from over 150 overseas trials to show that the use of medical grade GMP standard psilocybin and MDMA as part of psychotherapy have an established therapeutic value, as evidenced by the high remission rates for depression and PTSD after just 2-3 medicinal sessions in combination with psychotherapy.
A comparison with other substances listed in Schedule 8 of the Poisons Standard indicates that this is the right schedule for the medical use of these substances in controlled medical environments.
The fact that the treatments are available as part of expanded access schemes in a number of overseas countries, (and the TGA has given a number of approvals already under Australia’s Special Access Scheme-B) further supports these rescheduling submissions.
These medicines have also been shown to be extremely safe when used in a medically controlled environment by trained professionals.
Alternatives not working
At least one in eight adults, one in four older adults and one in thirty children are currently on antidepressants.
The relatively small remission rates from existing treatments is contributing to Australia’s devastating mental health statistics, which position Australia as second worst amongst all OECD nations, only ahead of Iceland.
With mental illness accelerating throughout the community as a result of the Covid-19 pandemic, the need for innovation has never been more urgent.
Peter Hunt said, ‘Rescheduling the medical use of MDMA as part of therapy in medically controlled environments will not open “the flood gates” to the use of these therapies in Australia.
‘The prescribing doctor will have to convince both the TGA and the relevant State/Territory Government that the needs of the particular patient warrant this therapy.’
Tania de Jong said, “Within those strictures we believe that the choice to use this therapy should be between the treating doctor and the patient suffering from the treatment resistant condition.
‘Australians are suffering and dying, and this treatment finally offers an opportunity for true healing. Our community needs the TGA’s support.’
Military veterans need urgent assistance
Veteran and psychiatrist, Dr Stuart Saker from NSW, has received twelve SAS-B approvals from the TGA to treat seriously unwell patients with psilocybin or MDMA assisted therapies depending on their specific condition.
He said, ‘All of these patients are veterans and a number are suicidal. They deserve a chance to get better and rescheduling will enable me to administer these treatments before it’s too late.’
The TGA will make its final decision on 22 April.
For people in the Northern Rivers of NSW who would like to learn more about the healing potential of psilocybin, Mind Medicine Australia is going to be screening Fantastic Fungi in Byron Bay on Thursday 25 March at 6:30pm.
This documentary by award-winning director Louie Schwartzberg touches on the ground-breaking work being done at Johns Hopkins, UCLA, New York University and elsewhere. MMA says the film ‘opens a door to a meaningful and important conversation and exploration into the potential mushrooms offer.’
Event details are here. Peter Hunt, Tania de Jong and other experts will be present for the screening. Trailer below: