Psilocybin & MDMA Fail To Make The Grade With Australian Theraputic Goods Administration (TGA)

It looks as though Australia will play the same game with psychedelic compounds as it has with medical cannabis. Slow and steady  which some may call a sensible conservative move others will say it denies patients access to badly needed treatments and then there’s the R&D and investment issue.

The US & Canada are moving quickly which means once the pandemic is over Australia’s best minds may well take their skills to a jurisdiction that is progressing the issue and anybody who has been looking at the rapidly burgeoning investment market will see it as an opportunity wasted.

Also it is worth noting in the language of the document, the echo of the war on drugs that in itself perpetuates the black market especially with regard to MDMA .

Kicking the can down the road, will, without doubt strengthen the black market for MDMA.

It is well known that Australians not only gobble the compound like candy they are willing to pay more for it than virtually anybody else on the planet so there’ll certainly be many illegal operators cheering this decision and knowing they’ll have a strong market for a minimum of a decade to come.

So all in all it’s a no to any rescheduling, very limited trials and everything stays the same with regard to the law which as all in  Australia know means a continuation of the same political tropes, heavy handed policing of young people.

See

Sydney Morning Herald December 2020 – Decriminalisation ruled out as government considers early drug intervention
The NSW government has ruled out decriminalising the possession of illicit drugs as part of its response to last year’s special commission of inquiry into ice. The inquiry heard months of harrowing evidence from health and judicial experts, families and communities affected by crystal methamphetamine and other amphetamine-type stimulants across NSW.
https://www.smh.com.au/national/nsw/nsw-government-rules-out-decriminalising-personal-drug-use-in-response-to-ice-inquiry-20201202-p56k1y.html

More of this

NSW government will ‘never take a soft stance’ on drugs: Berejiklian

 

 

Here are the key points

 

Psilocybin

  • 2.4 Interim decision in relation to psilocybin Interim decision Pursuant to regulation 42ZCZN of the Regulations, a Delegate of the Secretary has, in relation to the proposed amendment, made an interim decision not to amend the current Poisons Standard in relation to psilocybin.
  • Benefits: – There is limited but emerging evidence that psychedelic therapies may have therapeutic benefits in the treatment of a range of mental illnesses. These benefits are currently under investigation in clinical trials.
  • It will take years to develop a curriculum and accredited training process for psychiatrists.
  • To protect public health and prevent misuse, psilocybin should not be down-scheduled until all necessary safeguards have been established and implemented.
  • I note that psilocybin is an illicit drug with a high potential for misuse and an unknown safety profile.
  • The medium and long-term effects of psilocybin-assisted psychotherapy are unknown, particularly in vulnerable populations, and the risk of developing psychosis may be high.
  • The Australian Medical Association advised that more high-quality research, using largerscale studies, is required to establish the safety and efficacy of psychedelic therapies. The risk of psychosis and persistent hallucinations, especially in susceptible subpopulations, is likely to be high.
  • Having considered the risks to consumers, the lack of training for physicians, and the current state of research, I am of the view that Schedule 9 remains appropriate for psilocybin. I note that my decision does not affect current access to psilocybin for use in a clinical trial setting. Pending the outcome of current clinical research, the scheduling of psilocybin could be reconsidered in future applications. It is also important to note that the supply of psilocybin outside approved clinical trial settings is a criminal offence.

 

MDMA

  • 2.5 Interim decision in relation to N, α-Dimethyl-3,4- (methylenedioxy)phenylethylamine (MDMA) Interim decision Pursuant to regulation 42ZCZN of the Regulations, a Delegate of the Secretary has, in relation to the proposed amendment, made an interim decision not to amend the current Poisons Standard in relation to MDMA.
  • Benefits: – There is limited but emerging evidence that MDMA-assisted psychotherapy may have therapeutic benefits in the treatment of PTSD. These benefits are currently under investigation in clinical trials.
  • Risks: – Acute effects include high blood pressure and pulse rate, faintness and panic attacks. In severe cases, MDMA can cause loss of consciousness and seizures. – Secondary effects include involuntary jaw clenching, lack of appetite, depersonalisation, illogical or disorganised thoughts, restless legs, nausea, hot flashes or chills, headache, sweating and muscle/joint stiffness.
  • MDMA can reduce the ability to perceive and predict motion and can therefore result in accidents.
  • I note that MDMA is an illicit drug with a high potential for misuse in the Australian community, resulting in significant harms including seizures and deaths. MDMA shows some evidence of causing dependence, and may additionally lead to cognitive dysfunction in the medium or long term.

 

 

Here’s the full ruling text on both compounds.

Psilocybin

2.4 Interim decision in relation to psilocybin Interim decision Pursuant to regulation 42ZCZN of the Regulations, a Delegate of the Secretary has, in relation to the proposed amendment, made an interim decision not to amend the current Poisons Standard in relation to psilocybin.

Materials considered In making this interim decision, the Delegate considered the following material:

• The application to amend the current Poisons Standard with respect to psilocybin;

• The 575 public submissions, including 357 written submissions, received in response to the pre-meeting consultation under regulation 42ZCZK of the Regulations;

• The advice received from the Meeting of the Advisory Committee on Medicines Scheduling (ACMS #32);

• Subsection 52E(1) of the Therapeutic Goods Act 1989, in particular

(a) the risks and benefits of the use of a substance;

(b) the purposes for which a substance is to be used and the extent of use of a substance;

(c) the toxicity of a substance;

(d) the dosage, formulation, labelling, packaging and presentation of a substance;

(e) the potential for abuse of a substance; and

(f) any other matters considered necessary to protect public health;

• The Australian Health Ministers’ Advisory Council’s Scheduling Policy Framework (SPF 2018); • The Scheduling handbook: Guidance for amending the Poisons Standard;

• The ClinicalTrials.gov database, provided by the U.S. National Library of Medicine;

• A review by Reiff et al., Psychedelics and Psychedelic-Assisted Psychotherapy (2020);

• A review by Gill et al., The emerging role of psilocybin and MDMA in the treatment of mental illness (2020);

• A review by Vargas et al., Psilocybin as a New Approach to Treat Depression and Anxiety in the Context of Life-Threatening Diseases—A Systematic Review and Meta-Analysis of Clinical Trials (2020);

• A review by Goldberg et al., The experimental effects of psilocybin on symptoms of anxiety and depression: A meta-analysis (2020); and

• A clinical memorandum by the Royal Australian and New Zealand College of Psychiatrists, Therapeutic use of psychedelic substances (2020). Summary of ACMS advice to the Delegate The Committee recommended that the current scheduling of psilocybin remains appropriate.

Therapeutic Goods Administration Delegate’s interim decisions and reasons for decisions (ACCS#29, ACMS#32, Joint ACMS-ACCS #26, November 2020)

3 February 2021

Page 15 of 37 Members agreed that the relevant matters under Section 52E(1) of the Therapeutic Goods Act 1989 included:

(a) the risks and benefits of the use of a substance;

(b) the purposes for which a substance is to be used and the extent of use of a substance;

(c) the toxicity of a substance;

(d) the dosage, formulation, labelling, packaging and presentation of a substance;

(e) the potential for abuse of a substance; and

(f) any other matters considered necessary to protect public health.

The reasons for the advice included:

a) the risks and benefits of the use of a substance

 Benefits: – There is limited but emerging evidence that psychedelic therapies may have therapeutic benefits in the treatment of a range of mental illnesses. These benefits are currently under investigation in clinical trials.

 Risks: – There remain many unknown factors and side effects, especially in the long term. The risks of developing psychosis, especially in vulnerable populations, must be established in a clinical trial setting. – Can cause tachycardia and transient increases in blood pressure. – Psilocybin, when misused, can caused psychosis.

b) the purposes for which a substance is to be used and the extent of use of a substance –

Psilocybin is taken in combination with psychotherapy for the treatment of depression, PTSD, anxiety, or end of life distress. – Psilocybin-assisted psychotherapy sessions typically last 6 – 8 hours, relying on two trained specialists. The regime consists of 1 – 3 psychedelic-assisted therapy sessions, usually supplemented with ‘integrative’ therapy sessions where psilocybin is not used.

c) the toxicity of a substance –

The lethal dose is thought to be 6 g, although evidence around toxicity may be premature. – The potential adverse effects, particularly relating to multi-drug toxicity, are unknown.

d) the dosage, formulation, labelling, packaging and presentation of a substance –

A typical dose in the context of psychotherapy is 25 – 35 mg, depending on subject weight. An optimal therapeutic dosage has not been established.

e) the potential for abuse of a substance – There is a high risk of diversion for misuse, even in conjunction with Schedule 8 controls.

f) any other matters that the Secretary considers necessary to protect public health – There are significant benefits to waiting for the results of clinical trials. Psilocybinassisted psychotherapy may eventually prove to be safe and efficacious, but the evidence does not yet suggest this. –

It will take years to develop a curriculum and accredited training process for psychiatrists.

To protect public health and prevent misuse, psilocybin should not be down-scheduled until all necessary safeguards have been established and implemented.

Therapeutic Goods Administration Delegate’s interim decisions and reasons for decisions (ACCS#29, ACMS#32, Joint ACMS-ACCS #26, November 2020) 3 February 2021 Page 16 of 37 Reasons for the interim decision (including findings on material questions of fact)

I have made an interim decision to retain the scheduling of psilocybin in the current Poisons Standard. I agree with the Committee’s findings that the relevant provisions of section 52E of the Therapeutic Goods Act 1989 are

(a) the risks and benefits of the use of a substance;

(b) the purpose for which a substance is to be used and the and extent of use of a substance;

(c) the toxicity of a substance;

(d) the dosage, formulation, labelling, packaging and presentation of a substance;

(e) the potential for abuse of a substance; and

(f) any other matters that the Secretary considers necessary to protect public health.

The Scheduling Policy Framework (SPF 2018) provides that substances included in Schedule I to the United Nations Convention on Psychotropic Substances 1971, and without an established therapeutic value, should be classified in Schedule 9.

In my view, psilocybin fits these scheduling factors, and is not currently appropriate for listing as a Schedule 8 substance.

I note that psilocybin is an illicit drug with a high potential for misuse and an unknown safety profile.

The medium and long-term effects of psilocybin-assisted psychotherapy are unknown, particularly in vulnerable populations, and the risk of developing psychosis may be high.

Clinical trials will be essential to evaluating risks, but only three phase II trials have been completed.

According to the ClinicalTrials.gov database, 11 phase II trials are currently either recruiting or underway, and no phase III trials have been registered.

I note that St Vincent’s Hospital Melbourne is currently undertaking Australia’s first psychedelic clinical trial for terminally ill patients who are experiencing depression or anxiety.

Given the emerging evidence base regarding safety and efficacy, I believe that down-scheduling is premature.

In forming this view, I have considered the findings of a recent review in the American Journal of Psychiatry, which concluded that, although research is promising, the overall database is insufficient for regulatory approval for clinical use.

Several other reviews and meta-analyses published this year also draw similar conclusions, which describe promising results for early trials but advise that the current sample size is small (Gill et al., 2020; Vargas et al., 2020; Goldberg et al., 2020).

After reviewing these papers, I affirm my conclusion that further research is required, with larger treatment populations and stringent placebo controls.

I also note the findings of a recent clinical memorandum on psychedelic therapies, published by the Royal Australian and New Zealand College of Psychiatrists (RANZCP), which found that evidence of safety and efficacy is limited but emerging.

The memorandum highlights a number of potential risks, particularly the possibility that psilocybin can induce prolonged psychotic disorders in patients with a family history of psychosis.

To minimise these risks, the RANZCP concluded that further research is required – much of which is already underway.

I believe that these findings support my conclusion that current use of psilocybin should be limited to carefully monitored research trials.

In making my decision, I have taken into account the two ‘Breakthrough Therapy Designations’ that have been granted by the U.S. Food and Drug Administration. I note that, while these designations indicate that the therapy shows promise, they do not equate to FDA approval.

Currently, no comparable country has down-scheduled psilocybin to a category equivalent to Schedule 8, and at present, there is no international framework for how to handle psychedelicassisted therapies. I have taken into account all 575 responses that were received during the pre-meeting consultation, noting that 553 were supportive of the proposed amendment, 11 partially supportive and 11 opposed.

While the submissions indicate significant public support for rescheduling, few submissions addressed the factors relevant to scheduling.

I have read and considered all responses in making my interim decision. Therapeutic Goods Administration Delegate’s interim decisions and reasons for decisions (ACCS#29, ACMS#32, Joint ACMS-ACCS #26, November 2020) 3 February 2021 Page 17 of 37

I find that the points raised in public submissions from several peak bodies were highly pertinent, noting the following concerns and recommendations:

• The RANZCP advised that further research is required to assess the efficacy, safety, and effectiveness of psychedelic therapies, emphasising that appropriate treatment methodologies and training protocols do not yet exist.

• The Australian Medical Association advised that more high-quality research, using largerscale studies, is required to establish the safety and efficacy of psychedelic therapies. The risk of psychosis and persistent hallucinations, especially in susceptible subpopulations, is likely to be high.

• Psychedelic Research in Science and Medicine advised that, to ensure safe and ethical use, any decision to downschedule should include an extensive three-year implementation plan.

In addition, psilocybin-assisted psychotherapy has not yet commenced phase 3 trials, and will require several years of further research to establish efficacy.

Having considered the risks to consumers, the lack of training for physicians, and the current state of research, I am of the view that Schedule 9 remains appropriate for psilocybin. I note that my decision does not affect current access to psilocybin for use in a clinical trial setting. Pending the outcome of current clinical research, the scheduling of psilocybin could be reconsidered in future applications. It is also important to note that the supply of psilocybin outside approved clinical trial settings is a criminal offence.

I agree with the Committee’s advice that the current spelling of the Schedule 9 entry remains appropriate, noting that the spelling “psilocybine” is consistent with the International Nonproprietary Name and British Approved Name of the substance.

 

MDMA

2.5 Interim decision in relation to N, α-Dimethyl-3,4- (methylenedioxy)phenylethylamine (MDMA) Interim decision Pursuant to regulation 42ZCZN of the Regulations, a Delegate of the Secretary has, in relation to the proposed amendment, made an interim decision not to amend the current Poisons Standard in relation to MDMA.

Materials considered In making this interim decision, the Delegate considered the following material:

• The application to amend the current Poisons Standard with respect to MDMA;

• The 478 public submissions, including 254 written submissions, received in response to the pre-meeting consultation under regulation 42ZCZK of the Regulations;

• The advice received from the Meeting of the Advisory Committee on Medicines Scheduling (ACMS #32);

• Subsection 52E(1) of the Therapeutic Goods Act 1989, in particular

(a) the risks and benefits of the use of a substance;

(b) the purposes for which a substance is to be used and the extent of use of a substance;

(c) the toxicity of a substance;

(d) the dosage, formulation, labelling, packaging and presentation of a substance;

(e) the potential for abuse of a substance; and

(f) any other matters considered necessary to protect public health;

• The Australian Health Ministers’ Advisory Council’s Scheduling Policy Framework (SPF 2018); Therapeutic Goods Administration Delegate’s interim decisions and reasons for decisions (ACCS#29, ACMS#32, Joint ACMS-ACCS #26, November 2020) 3 February 2021 Page 18 of 37

• The Scheduling handbook: Guidance for amending the Poisons Standard;

• The ClinicalTrials.gov database, provided by the U.S. National Library of Medicine;

• A review by Illingworth et al., A comparison of MDMA-assisted psychotherapy to nonassisted psychotherapy in treatment-resistant PTSD: A systematic review and meta-analysis;

• A review by Bahji et al., Efficacy of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for posttraumatic stress disorder: A systematic review and meta-analysis; and

• A clinical memorandum by the Royal Australian and New Zealand College of Psychiatrists, Therapeutic use of psychedelic substances (2020).

Summary of ACMS advice to the Delegate The Committee recommended that the current scheduling of MDMA remains appropriate.

Members agreed that the relevant matters under Section 52E(1) of the Therapeutic Goods Act 1989 included:

(a) the risks and benefits of the use of a substance;

(b) the purposes for which a substance is to be used and the extent of use of a substance;

(c) the toxicity of a substance;

(d) the dosage, formulation, labelling, packaging and presentation of a substance;

(e) the potential for abuse of a substance; and

(f) any other matters considered necessary to protect public health.

The reasons for the advice included:

a) the risks and benefits of the use of a substance

 Benefits: – There is limited but emerging evidence that MDMA-assisted psychotherapy may have therapeutic benefits in the treatment of PTSD. These benefits are currently under investigation in clinical trials.

 Risks: – Acute effects include high blood pressure and pulse rate, faintness and panic attacks. In severe cases, MDMA can cause loss of consciousness and seizures. – Secondary effects include involuntary jaw clenching, lack of appetite, depersonalisation, illogical or disorganised thoughts, restless legs, nausea, hot flashes or chills, headache, sweating and muscle/joint stiffness.

– Long-term use can result in sleep disturbances, difficulties with concentration, depression, heart disease, impulsivity and decreased cognitive function.

– MDMA can reduce the ability to perceive and predict motion and can therefore result in accidents.

b) the purposes for which a substance is to be used and the extent of use of a substance –

MDMA is taken in combination with psychotherapy for the treatment of PTSD. –

MDMA-assisted psychotherapy sessions typically last 6 – 8 hours, relying on two trained specialists. The regime consists of 1 – 3 psychedelic-assisted therapy sessions, usually supplemented with ‘integrative’ therapy sessions where MDMA is not used.

c) the toxicity of a substance –

The lethal dose is 10 – 20 mg/kg. –

The potential adverse effects are unknown in the context of psychotherapy.

Therapeutic Goods Administration Delegate’s interim decisions and reasons for decisions (ACCS#29, ACMS#32, Joint ACMS-ACCS #26, November 2020) 3 February 2021 Page 19 of 37

d) the dosage, formulation, labelling, packaging and presentation of a substance –

Optimal dosages have not been established, especially outside of PTSD treatment. –

A typical dose in the context of psychotherapy is 1-2 mg.

This is often followed by an optional half-dose 1.5 to 2.5 hours into the session.

e) the potential for abuse of a substance –

It is not clear whether MDMA causes dependence.

However, it affects many of the same neurotransmitter systems in the brain that are targeted by drugs with an abuse and dependence liability, and some studies report symptoms of dependence in users. –

There is a high risk of diversion for misuse, even in conjunction with Schedule 8 controls.

f) any other matters that the Secretary considers necessary to protect public health –

There are significant benefits to waiting for the results of clinical trials. MDMA-assisted psychotherapy may prove to be safe and efficacious, but the evidence does not yet suggest this – especially for conditions outside of PTSD. –

It will take time to develop a curriculum and accredited training process for psychiatrists. To protect public health and prevent inappropriate use, MDMA should not be down-scheduled until all necessary safeguards have been established and implemented.

Reasons for the interim decision (including findings on material questions of fact) I have made an interim decision to retain the scheduling of MDMA in the current Poisons Standard. I agree with the Committee’s findings that the relevant provisions of section 52E of the Therapeutic Goods Act 1989 are

(a) the risks and benefits of the use of a substance;

(b) the purpose for which a substance is to be used and the and extent of use of a substance;

(c) the toxicity of a substance;

(d) the dosage, formulation, labelling, packaging and presentation of a substance;

(e) the potential for abuse of a substance; and

(f) any other matters that the Secretary considers necessary to protect public health.

The Scheduling Policy Framework (SPF 2018) provides that substances included in Schedule I to the United Nations Convention on Psychotropic Substances 1971, and without an established therapeutic value, should be classified in Schedule 9.

In my view, MDMA fits these scheduling factors, and is not currently appropriate for listing as a Schedule 8 substance.

I note that MDMA is an illicit drug with a high potential for misuse in the Australian community, resulting in significant harms including seizures and deaths. MDMA shows some evidence of causing dependence, and may additionally lead to cognitive dysfunction in the medium or long term.

Clinical trials will be essential to evaluating these risks. While several phase II trials have been completed, these lack appropriate sample sizes and control groups, and require rigorous follow-up in phase III.

According to the ClinicalTrials.gov database, a single phase III trial has been registered, and completed, though its results are not yet publically available.

Given the emerging evidence base regarding safety and efficacy, I believe that down-scheduling is premature.

In forming this view, I have also considered the findings of a recent systematic review and metaanalysis in the Journal of Psychopharmacology, which concluded that MDMA-assisted psychotherapy requires data from larger scale studies before approval for clinical use.

The same sentiment was echoed in an earlier review, published in Progress in Neuro-Psychopharmacology and Biological Psychiatry, which concluded that larger sample sizes and longer durations of treatment and follow-up were warranted.

After reviewing these papers, I affirm my conclusion that further research is required. Therapeutic Goods Administration Delegate’s interim decisions and reasons for decisions (ACCS#29, ACMS#32, Joint ACMS-ACCS #26, November 2020) 3 February 2021 Page 20 of 37

I also note the findings of a recent clinical memorandum on psychedelic therapies, published by the Royal Australian and New Zealand College of Psychiatrists (RANZCP), which found that evidence of safety and efficacy is limited but emerging.

The memorandum highlights a number of potential risks, particularly the possibility that MDMA can induce prolonged psychotic disorders in patients with a family history of psychosis.

To minimise these risks, the RANZCP concluded that further research is required – much of which is already underway.

I believe that these findings support my conclusion that current use of MDMA should be limited to carefully monitored research trials.

In making my decision, I have taken into account the ‘Breakthrough Therapy Designation’ that has been granted by U.S. Food and Drug Administration.

I note that, while this designation indicates that the therapy shows promise, it does not equate to FDA approval.

Currently, no comparable country has down-scheduled MDMA to an equivalent category to Schedule 8, and there is no international framework for how to handle psychedelic-assisted therapies.

I have taken into account all 478 responses that were received during the pre-meeting consultation, noting that 453 were supportive of the proposed amendment, 14 partially supportive and 11 opposed.

While the submissions indicate significant public support for rescheduling, a significant fraction included no written justification, or directly paraphrased the sponsor, and few submissions were from practicing psychiatrists.

I have read and considered all responses in making my interim decision. I find that the points raised in public submissions from several peak bodies were highly pertinent, noting the following concerns and recommendations:

• The RANZCP advised that further research is required to assess the efficacy, safety, and effectiveness of psychedelic therapies, emphasising that appropriate treatment methodologies and training protocols do not yet exist.

• The Australian Medical Association advised that more high-quality research, using largerscale studies, is required to establish the safety and efficacy of psychedelic therapies. The risk of psychosis and persistent hallucinations, especially in susceptible subpopulations, is likely to be high.

• Psychedelic Research in Science and Medicine advised that any decision to down-schedule should include an extensive two-year implementation plan.

Only a limited number of Australian medical professionals are currently trained to provide MDMA-assisted psychotherapy, and premature down-scheduling may put patients at increased risk of harm.

Having considered the risks to consumers, the lack of training for physicians, and the current state of research, I am of the view that Schedule 9 remains appropriate for MDMA.

I note that my decision does not affect current access to MDMA for use in a clinical trial setting. I would also like to note that the supply of MDMA outside of its use in approved clinical trials remains a criminal offence. Pending the outcome of current clinical research, the scheduling of MDMA could be reconsidered in future applications.

 

Here’s the full Document

notice-interim-decisions-proposed-amendments-poisons-standard-acms-accs-and-joint-acms-accs-meetings-november-2020

 

The ABC Report….

The legal and illegal ways people are turning to psychedelics as the drug regulator rejects reclassification bid

Drug proposal rejected

Australia’s drug regulator, the Therapeutic Goods Administration (TGA), yesterday rejected an application seeking to have two currently prohibited drugs rescheduled as controlled medicines in Australia.

Psilocybin — the drug used in the St Vincent’s trial — was one of them.

The proposal sought to make it easier for doctors to prescribe the psychedelic as well as MDMA, also known as ecstasy, to people suffering from chronic anxiety, depression and PTSD.

The TGA’s interim decision to reject the change follows an application made last July by the psychedelics advocacy group Mind Medicine Australia (MMA), run by soprano singer Tania De Jong and chaired by her investment banker husband, Peter Hunt.

MMA points to clinical trials completed overseas, where psilocybin was found to be effective in treating anxiety and depression in terminally ill cancer patients.

Last November, Johns Hopkins University in the US found psilocybin to be four times more effective than medicines traditionally prescribed to treat major depression.

But these trials have not yet advanced to Stage 3, which tests safety and efficacy on large populations.

Ms De Jong and Mr Hunt expressed disappointment yesterday at the TGA’s desire to wait until current clinical research is complete before the rescheduling of these controversial drugs is considered.

“That could be years away,” Mr Hunt said.

“How many people are going to suffer between now and then? And frankly, how many people are going to die from suicide because they can’t actually get the treatments they need to get?

“It is frankly nonsense to make these people who are suffering wait any longer.”

The TGA cited advice from the Royal Australian and New Zealand College of Psychiatrists, which argued that while there are indications emerging that psilocybin can offer therapeutic benefits, the evidence “just isn’t quite there yet”.

Read full article at

https://www.abc.net.au/news/2021-02-04/psychedelics-therapeutic-use-cancer-trial-regulator-rejects-bid/13112074

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