Update: The Delegate of the Secretary of the Commonwealth Government's Department of Health is Seeking to Block Access to Medicinal Psilocybin and MDMA, Despite Overwhelming Public Support & Clearly Established Therapeutic Value
Make Your Voice Heard and Tell the TGA You OPPOSE the Decision to Continue the Prohibition of Medicinal Psychedelics in Australia
00
DAYS
00
HOURS
00
MINS
00
SECS
It is Time for You to Speak Truth to Power
MMA’s applications for rescheduling the medical use of psilocybin and MDMA as part of therapy have been rejected yet again in the TGA’s Interim Decision. This is despite the strong controls that MMA proposed, the outstanding safety and efficacy data coming from overseas trials and the failure of current treatments to help so many people suffering debilitating mental illnesses.
This was also despite massive public interest - there were 6,650 public submissions lodged in relation to our psilocybin application and 6,505 public submissions lodged in relation to our MDMA application (representing more than a 10-fold increase in the number of public submissions lodged when compared to our previous applications made in July 2020. A staggering 98% of these submissions showed support for rescheduling).
The TGA’s Interim Decision, and MMA’s applications can be found on the TGA website here. A summary of the delegate’s arguments and MMA’s responses can be viewed here and MMA's Media Release can be viewed here.
To say that we are extremely disappointed with the Delegate’s reasoning in the Interim Decision is putting it mildly.
The TGA's response also contains a very misleading statement highlighted below:
“In the case of MDMA, expanded patient access schemes have been instituted in countries including the United States, Israel and Switzerland under compassionate grounds for the treatment of PTSD.
These are analogous to the current use of the Special Access Scheme in Australia, which allows patient access to Schedule 9 substances with approval under particular circumstances.”
Not a single patient has been able to access these therapies in Australia via the Special Access Scheme, despite over 20 approvals being granted by the TGA under the Special Access Scheme, because of the refusal of State and Territory Governments to allow those approvals to be implemented.
This is why rescheduling is so important. At the moment the States and Territories around Australia have no permit systems available for doctors and their patients to access these therapies. Permit systems become available in all States and Territories if these medicinal therapies are moved to Schedule 8.
We have the absurd situation today where a doctor who receives approval from the TGA to prescribe these medicines as part of therapy to a patient suffering from treatment resistant depression or treatment resistant post- traumatic stress disorder would be criminally liable under the recreational drug provisions in the State or Territory where the doctor sought to provide the treatment.
Please use the buttons below to download detailed documents outlining MMA’s rescheduling applications and our response OPPOSING the delegate’s interim decision.
The full applications lodged by MMA, as well as the TGA's Interim Decision and our summary response OPPOSING the Interim Decision can be viewed using the buttons below.
Frequently Asked Questions
Do I support or oppose the Interim Decision?
Will my submission OPPOSING the Interim Decision actually matter?
Why is it important to lodge a submission?
Do I have to be a clinician?
Are the submissions anonymous?
Do I have to write a detailed submission?
Content Warning: The video below speaks of suicide and may be confronting for some viewers
"Please reschedule these substances for therapeutic use. Please don't let another child lose a parent to suicide."
Vanessa tragically lost her husband Franco to suicide in 2021 after a 3 year battle with severe, treatment-resistant depression. She was hoping to access psychedelic-assisted therapy for him after seeing the incredible results from overseas trials, but he took his life before she could access this treatment.
She shares her story in a letter to the Prime Minister and asks for his help in allowing treatment-resistant patients to access these potentially life saving treatments.
The Majority of Australians ALREADY Support the Regulation of Psychedelic-Assisted Therapy... But The Regulators Don't Know Where You Stand.
Please make your Submission OPPOSING the Delegate's Interim Decision by 24th November and encourage everyone you know to do the same.
If you would like to see the full poll results, click here.
Content Warning: The video below speaks of suicide and may be confronting for some viewers
"If he had access to psychedelic-assisted therapies, my boy would be alive today. I could hold him..."
Dr Brian Walker MLC is a GP and member of the Legislative Council in the Western Australian Government. He speaks of the tragic death of his son earlier this year, and his conviction that access to psychedelic-assisted therapy could have avoided it.
Trigger Warning: some viewers may find these stories and the cost of inaction distressing
"To my mind, the clinical evidence is clear...every day that this takes is a day that we lose people, and that's not acceptable..."
Dr Tra-ill Dowie, dual PhD holder and co-founder of the Mind Medicine Institute speaks of the injustice of denying those in need treatments that can alleviate their suffering.
This is Your Chance to Have Your Voice Heard
The submissions period ends November 24th. Please take action now and OPPOSE the Interim Decision.
If we aren't successful in rescheduling these medicines now, it's another 15 months before vulnerable Australians with treatment resistant mental illness can access these therapies that may play a crucial role in alleviating their suffering.
Please click the button below to make your submission and OPPOSE the Interim Decision.
Click here to Show Your Opposition to the TGA's Interim DecisionFollow These Simple Instructions to Make a Submission
How to Lodge a Submission
Go to the TGA's consultation hub: https://consultations.tga.gov.au/tga/mdma-ps-of-june-2022-interims/
- Once on the hub page follow the link “SUBMIT YOUR RESPONSE HERE”
- Continue through the navigation using Continue. You can save a draft and return to your submission at any time using the "Save and come back later button".
- You will first be asked to enter your details, then select which category you belong to from consumer/patient, registered healthcare professional, professional researcher or none of the above.
- Then select the medicine(s) you are choosing to make your submission for and add your written submission if making one.
IMPORTANT NOTE: This page is requesting your response to the Interim Decision. Therefore, select OPPOSE on this page to show that you would like MDMA and/or psilocybin to be rescheduled.
Please see screenshot of this page below (where an individual has selected “Oppose" to the interim decision of rejecting rescheduling).
After selecting "Oppose" for both medicines, you can paste a written response into the text box below or upload a document.
For the final step, you will be asked if you would like to make your submission public, unnamed or private and select “Continue”. Your submission will be much more powerful if you are prepared to be named.
Some Guidance in Providing a Written Response
In your written response you can speak from the heart to share your personal reasons for opposing this Interim Decision.
Below you’ll find some of the reasons we feel that it is wrong.
- There is clear evidence that “established therapeutic value” has been demonstrated.
The Delegate’s assertion that there is insufficient evidence of established therapeutic value to reschedule these substances is wrong. The amount of evidence required for a Schedule 8 substance is significantly less than required for registration (which requires phase 3 trials). The results from the MDMA and psilocybin trials to date show strong efficacy and minimal adverse events.
There is actually much more evidence to support the established therapeutic value of MDMA and psilocybin when used as part of psychotherapy than there was for the medical use of cannabis when it was rescheduled to Schedule 8 of the Poisons Standard in 2016.
PTSD and Depression are both notoriously hard to treat with current treatments and the failure rate is unacceptably high. Current treatments (which primarily consist of pharmaceuticals and/or psychotherapy) are only estimated to achieve remission rates in less than 10% of PTSD patients and one-third of Depression patients. In contrast remission rates in the first MAPS Phase 3 trial using MDMA assisted therapy were 67% which compared to 52% after the Phase 2 trials (increasing to 68% after 12 months). Remission rates in the Psilocybin Phase 2 trials were much higher than in the placebo or antidepressant groups. In all of the Psilocybin and MDMA trials adverse events have been minor and easily managed.
The views in our rescheduling applications that the established therapeutic value requirement had been satisfied were supported by leading experts in the field including Australia’s leading psychopharmacologist Professor Arthur Christopoulos from Monash University and Drug Science in the UK Chaired by World leading neuropsychopharmacologist Professor David Nutt who heads up the Centre for Psychedelic Research at Imperial College London.
- There are major risks arising from inaction and the suffering of those with treatment resistant mental illness.
The Delegate’s Interim Decision completely ignores the simple fact that there are countless people in our society who are suffering greatly from mental ill-health that is unable to be addressed with current treatment options. Some of these people are at risk of suicide, and on average we lose roughly 3000 Australians to suicide every year.
We cannot ignore the plight of these people. Those with appropriate diagnoses urgently need the opportunity to try these safe and effective treatments, under proper supervision in a medically controlled environment. There is substantial evidence from hundreds of trials and special access schemes around the world to support the use of both psilocybin and MDMA in clinical environments. To withhold these treatments from those suffering so terribly is inhumane, unkind and uncaring. It is also a breach of our basic Human Right to access safe and effective medicines.
Please tell your personal stories and why access is so important to you, your family and the community.
- We have a dysfunctional Federal system as it applies to the TGA’s Special Access Scheme for Schedule 9 Medicines which is unlike other nations with functional special access schemes.
The delegate made the comment below. The emboldened section is inexplicably incorrect:
“In the case of MDMA, expanded patient access schemes have been instituted in countries including the United States, Israel and Switzerland under compassionate grounds for the treatment of PTSD.
These are analogous to the current use of the Special Access Scheme in Australia, which allows patient access to Schedule 9 substances with approval under particular circumstances.”
Not a single patient has been able to access these therapies in Australia via the Special Access Scheme despite over 20 patients being granted approvals by the TGA under the Special Access Scheme, because there is no permit system at the State and Territory level for the use of Schedule 9 medicines.
The Delegate’s claim that our special access scheme is analogous to the functioning equivalents in the United States, Israel and Switzerland is simply untrue. In those countries they actually work and patients are being healed through these safe and effective treatments after just 2-3 medicinal doses in combination with a short course of psychotherapy.
- We have not been provided with Proper Disclosure and Accountability
We need the Delegate who makes the decision to be named so that we can all assess that person's experience and qualifications and the need for each member of the advisory committee to explain their position and how they vote. This should be available for all Australians.
Remember: To be valid your submissions must be lodged online with the TGA on or before Thursday 24th November 2022. It's very important that you put your submissions in your own words.
This is Your Chance to Have Your Voice Heard
The submissions period ends November 24th. Please take action now.
If we aren't successful in rescheduling these medicines now, it's another 15 months before vulnerable Australians with treatment resistant mental illness can access these therapies that may play a crucial role in alleviating their suffering.
Click the button below to make your submission.
Click here to Show Your Opposition to the TGA's Interim DecisionCopying your Submission to Your State or Territory Minister of Health and Minister of Mental Health and Your Local Federal and State MPs
This is important because each of these individuals are there to look after your interests. Its critical to let them know why rescheduling on the basis that we are proposing is important to you.
- You can find the name and email address of your local State MP here.
- You can find the name and address of your Federal MP here.
- To email the Federal and State Ministers of Health, you can use the links below.
- Write them an email notifying them of this issue, why it matters to you and request that they are briefed and take action to represent the views of their constituents on this matter.
- Please also phone them and demand change!
Federal Health Minister: Mark Butler
Federal Assistant Minister for Mental Health and Suicide Prevention: Emma McBride
ACT Health Minister: Rachel Stephen-Smith
ACT Mental Health Minister: Emma Davidson
NSW Health Minister: Brad Hazzard
NSW Mental Health Minister: Bronnie Taylor
NT Health Minister: Natasha Fyles
QLD Health Minister: Yvette D'Ath
SA Health Minister: Chris Picton
TAS Health + Mental Health Minister: Jeremy Rockliff
VIC Health Minister: Mary-Anne Thomas
00
DAYS
00
HOURS
00
MINS
00
SECS
