Green light for drug trials

An innovative approach towards combatting Australia’s mental health crisis may be through psychedelic assisted therapies.

ECU Medical Health and Science Researcher Dr Stephen Bright said the Federal Government’s decision to fund $15 million worth of clinical trials of MDMA and psychedelic drugs in combination with psychotherapy was “fantastic”.

“The government donating money to this kind of research is world leading,” Dr Bright said.

“From what I’m aware the only other country that has released funding for this research is Germany,” Dr Bright said.

“The barrier up until now hasn’t just been funding but conservatism.”

Dr Bright said Australia had only recently begun research in these areas and that it would typically be funded philanthropically.

The funding announcement followed an interim decision made by the Therapeutic Drug Association that knocked back the rescheduling of MDMA and psilocybin from a prohibited substance (schedule 9) to a controlled medicine (schedule 8).

“I believe the application that was made to the TGA was made prematurely,” Dr Bright said.

“There is promising evidence that MDMA and psilocybin might be affected adjunct psychotherapy to the treatment of some mental health conditions but until phase 3 clinical trials have been completed then this isn’t the evidence in terms of both efficacy and safety.”

Mind Medicine Australia Executive Director Tania de Jong said there were a “number of issues” with the TGA’s decision.

“The medicine should be moved from (schedule 9) to (schedule 8) now regardless of any further clinical trials in Australia,” Ms de Jong said.

“To ensure that the clinical trials have access to the medicines as simply as possible we will be far better off to be in (schedule 8) because it means the medicines can be easily brought into Australia for trials.”

Mind Medicine Australia has put in a detailed final submission against the issues raised by the TGA.

Ms De Jong said there was an “unavoidable amount of suffering in Australia” and hoped the TGA would approve the rescheduling later this month.

“This effects every single one of us,” she said.

“If it’s not us it’s someone close to us.”

“Many people who have tried multiple different treatments should be given access to treatments that are safe and effective and to avoid further suffering and suicides.”