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Changes for Psilocybin and MDMA in Australia



The Therapeutic Goods Administration (TGA) has announced that Psilocybin and MDMA will be able to be prescribed by specially qualified psychiatrists for the treatment of particular mental health issues as of July 1, 2023.


This is a big deal! As Dr Stephen Bright points out, ‘This decision makes Australia the first country in the world to recognise MDMA and Psilocybin as medicines.’ This means people who would benefit from these therapies have a chance at accessing them through legal channels.

Read on to learn the facts of the TGA decision as well as the implications for patients and people who use psilocybin and MDMA in non-clinical settings.

Re-scheduling of psilocybin and MDMA in the Poisons Standard

Psilocybin and MDMA (3,4-methylenedioxy-methamphetamine)-containing medications can now be prescribed by specially qualified psychiatrists for the treatment of particular mental health issues as of July 1, 2023.

The TGA decision means that psilocybin and MDMA will be added to Schedule 8 (S8), permitting their use as Controlled Drugs. Psilocybin will be permitted only for treatment-resistant depression (TRD). MDMA will be permitted only for post-traumatic stress disorder (PTSD).

Psilocybin and MDMA will only be allowed to be prescribed by specialist psychiatrists under the following conditions: they must have approval from a Human Research Ethics Committee (HREC), and they must be authorised by the TGA under the Authorised Prescriber Scheme to prescribe the substances for these conditions.

The substances will also be available for approved clinical trials on treatment-resistant depression and PTSD.

The TGA states that psilocybin and MDMA are generally safe when used in a controlled environment under the supervision of properly qualified healthcare experts and in the dosages that have been studied in clinical trials. However, they also expressed a concern for patient vulnerability during the experience. Due to this, they determined that only psychiatrists who have been authorised under the Authorised Prescriber Scheme and are able to convince a Human Ethics Research Committee as well as the TGA that robust safety measures are in place to ensure patient safety should be eligible to prescribe.

Unauthorised possession of Psilocybin and MDMA as Schedule 8 drugs will remain illegal. Schedule 9 will be updated to keep current restrictions on all other uses of psilocybin and MDMA as prohibited substances. Due to their classification in state and territory legislation as drugs of dependence, dangerous drugs, or prohibited drugs, even though they are included in Schedule 8 of the Poisons Standard, the supply, use, or possession of psilocybin and MDMA may be illegal in some states and territories.

What This Means For Patient Access

Gaining access to psychiatrists is not easy, even for conventional treatments. In Victoria last year, patients were waiting up to six months to see a psychiatrist. Access for rural and regional patients remains difficult.

The Authorised Prescriber Scheme that psychiatrists need to go through to prescribe psilocybin or MDMA involves approval from both a human research ethics committee, and the TGA. We do not know how long this approval might take. But it’s safe to infer that for the next few years at least, very few psychiatrists will have gone through this process. So, there will not be many approved prescribers. Wait times could be much longer than for the average psychiatrist, though we would expect prescribers to prioritise patients with the greatest need.

In all likelihood, this will not be cheap either, particularly as psilocybin and MDMA are not on the PBS and are unlikely to be covered by any form of health insurance. Private psychiatric services are not well-funded by Medicare, and can cost up to $600 per hour.

We also note, as PRISM has expressed, that there are relatively few psychiatrists with specific training in psychedelic or MDMA-assisted therapy.

Finally, as the TGA has pointed out, it may be the case in some states that laws need to change to permit approved prescription of psilocybin or MDMA. This is likely the case in NSW, and we are assessing the impact in other states.

We flagged all of these potential issues when discussing potential rescheduling in May last year, and our expectations have not changed.

What This Means For Non-Clinical Use

In case it wasn’t obvious already, this does not mean that use, possession, growing or selling MDMA or psilocybin (in any form) are any less illegal than they were before. Telling the police that your bag of freshly picked shrooms or those couple of pingas in your pocket at a music festival are prescription medications is not going to get you out of trouble! Breaking the law remains a key risk associated with both of these substances. These changes do nothing to address this risk. The Australian Psychedelic Society remains committed to decriminalisation and related reforms to remove the criminal penalties for possession and use of illicit drugs and working towards safer supply.

We hope that the rescheduling will lead to a reduction in the stigma associated with these substances, and increased recognition of their potential benefits in both the general community and medical profession. But this also comes with the potential pitfall of psychedelics becoming something that psychiatry gets to play gatekeeper with. We do not feel that this would be an acceptable outcome.

Increases in community awareness of psychedelics bring their own complications, particularly when the medicines themselves are so hard to access legally. This decision makes education and harm-reduction work more important than ever before.

What Now?

The War on Drugs in Australia is not over. At best, it will be possible for those who would benefit from psilocybin or MDMA-assisted therapy to be able to access it without breaking the law. But this access will initially be slow and expensive.

Nonetheless, it’s a significant milestone to see our notoriously conservative national regulator recognise the therapeutic potential of these substances. It’s also noteworthy that the TGA is aware of the vulnerability of people during psychedelic experiences.

Even with this tiny step towards therapeutic access, many risks and much work remains. Maybe it’s too soon to be optimistic. But it feels like the right time to keep pushing hard for change that goes beyond the psychiatric profession, and gives us back a little more choice about what we put in our bodies and which experiences we have. If you’re interested in contributing to this, all you have to do is reach out – we need all the help we can get!


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Cronos Group Inc. Launches Medical Brand Peace Naturals in Germany




Cronos Group Inc. announced that it shipped its first order of bulk cannabis, which will be sold under the PEACE NATURALS®? brand in Germany. In July, Cronos signed a distribution agreement with Cansativa Group.

Cansativa is a market leader in the medical cannabis market and is a driving force in the German cannabis industry. Cansativa has a network of approximately 2,000 pharmacies domestically; they currently supply around 300,000 patients in Germany’s medical market. The recently announced regulatory changes in Germany, to reschedule cannabis and no longer label cannabis as a cannabinoid, are expected to unlock significant growth in the market.

Cansativa’s wide distribution network of pharmacies provides Cronos access to patients in Germany, including those with insurance coverage for medical cannabis. Additionally, in August 2023, a bill was introduced in the German parliament to legalize adult-use cannabis. Re-establishing Cronos and its PEACE NATURals®?

brand in the German market will position the Company to capitalize on this growing market, fueled by potential future legislative changes.

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Article: Gratefully Remembering The UK Microdot LSD of the 1970’s




This psychonaut remembers versions of these still knocking around in the early 1980’s. 5 sheets  made our live aid weekend in Brighton a very long one !


In the early 1970s, England was awash in LSD and much of it was produced by one clandestine organization: the Microdot Gang. Microdot LSD was known for its purity and for its potency. In fact, many users from the 1970s still remember it by name some fifty years later. At its apex in 1978, the Microdot Gangs’s autonomous distribution networks extended to Europe, Canada, Australia, and the United States. By the mid-1970s, British law enforcement made LSD distribution a top priority and launched Operation Julie, a massive investigation and sting operation that included hundreds of detectives and police officers. Operation Julie eventually led to 87 household raids and over 120 arrests in March of 1977. Alston Hughes, aka “Smiles,” a crucial LSD dealer for the Microdot gang, was arrested at his home in Llanddewi-Brefi, a remote and tranquil Welsh village. When the villagers heard of his arrest, they were shocked because Smiles was widely known for his affability and his fondness for buying free drinks at the local pub.

British law enforcement has typically regarded “Operation Julie” as an enormously successful sting operation that effectively curtailed the production of Microdot LSD. There have been nine books written about Operation Julie and many of them were written by detectives who participated in the historic investigation. Although the story of Operation Julie has often been dominated by law enforcement’s narrative of moral self-congratulation (“we took acid off the streets”), alternative histories of the Microdot era are now beginning to emerge.

Andy Roberts, noted historian of British psychedelic culture, has penned an engaging and thought provoking biography, In Search of Smiles, LSD, Operation Julie and Beyond (2023), that provides a lively portrait of the British counterculture in the 1970s. Recreating Hughes’s colorful life as a cannabis and LSD dealer in the halcyon days of the 1970s, In Search of Smiles succeeds because it mirrors the life experiences of many people who came of age in the golden era of British psychedelia (1960s and the early 1970s). In literary terms, Roberts’s narrative of Smiles’s topsy turvy life also succeeds as a Dickensian tale of deferred redemption: its protagonist endures horrific abuse from his sadistic Mancunian stepfather, yet he somehow manages to retain his good nature and humanity. While serving in the army, the abuse continues when Hughes is beaten by his superior officer, Lance Corporal Lunn: “[Hughes] bore the beatings stoically, I smiled at him and he called me “smiler,” a nickname he would carry for several years until his first wife shortened it to “Smiles.” After leaving the army, Smiles travels to free festivals (Bath Free Festival of Blues and Progressive Music in 1970, Phun City, and the iconic Isle of Wight festival) where he discovers community—like minded hippies and free spirits—as well as LSD and free love. By narrating the story of Hughes’s transformation, Roberts manages to also provide a vivid portrait of British alternative culture in the era before Thatcher comes to power.

Read the interview

Gratefully Remembering Microdot LSD in the Seventies

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Ketamine Healthcare via Enthea; Now Nationwide




Ketamine is one of the up-and-comers in the new hallucinogen craze that’s taking over; and it just got pushed to a whole new level. According to recent reports, ketamine is now offered by healthcare provider Enthea, throughout the entire US.

A bit about ketamine and hallucinogens

First off, ketamine isn’t a psychedelic. It’s often classified that way today, as a means of simplifying for the public, what is actually a complicated categorization system of drugs. There are different kinds of hallucinogens, and psychedelics are one grouping. However this grouping only consists of LSD, DMT, psilocybin, and mescaline. Though MDMA is often included in this group, its technically classified as a psychostimulant. These drugs (psychedelics and MDMA) are specifically known to cause an agonist response at serotonin receptors; which means they raise the amount of serotonin in the system.

Ketamine is classified as a dissociative hallucinogen, along with drugs like PCP and DXM. These drugs have a primary action as antagonists at NMDA receptors, among other actions. The other official grouping of hallucinogens, is deliriants; a classing which involves plants like datura, and compounds like scopolamine, or even the allergy medicine Benadryl. These are all anticholinergics, which means they have an antagonistic effect at acetylcholine receptors, and decrease acetylcholine in the system.

Ketamine is a synthetic, lab-made drug, which was formulated in 1962 by the pharmaceutical company Parke-Davis. The idea was to find a powerful anesthetic, which didn’t cause damage, or lower vital body processes; like blood pressure, or breathing rates. Ketamine works as a sedative, but not as a hypnotic; meaning it makes a person drowsy, without putting them to sleep. It causes what’s described as “electrophysiological and functional dissociation between thalamocortical and limbic systems.” In my personal experience it quite literally feels like the parts of the brain are moving away from each other.

Enthea healthcare provides clinic and at-home ketamine therapy
Enthea healthcare provides clinic and at-home ketamine therapy

Unlike a lot of the drugs we speak about here, ketamine is not a Schedule I compound. In fact, it’s a Schedule III compounds, legal for medical use as an anesthetic in humans and animals. However, as per FDA rules for off-label prescribing; wherein a drug can be prescribed by a physician for uses other than what its officially cleared for; ketamine has been at the center of a growing gray medical market. Legal by off-label prescribing, but with no governmental regulation for what its being used for.

This loophole spawned an entire industry of clinics that offer treatments for pain and different psychological disorders. And patients don’t need to worry about their primary care physician (or specialist) giving them a prescription; they can get it directly from the clinic. This is a major benefit, as individual doctor opinions do not update at the same speeds.

Ketamine now offered as healthcare throughout US

Gray markets present an issue for government bodies. Unlike defined black markets, they aren’t necessarily illegal; in fact, by definition, they’re not. But they’re also not legal markets, which means they’re hard to go after legally, but they also provide no additional tax benefit to regulating bodies. As such, regulating bodies either want to get rid of them (think vapes and cannabinoids), or formally regulate them. Currently with ketamine, there’s a standstill; and this is being taken advantage of by Enthea Healthcare.

I’ve covered Enthea before, and its pioneering efforts to provide ketamine as a basic healthcare benefit. The company is the first licensed workplace healthcare provider for psychedelic therapies, and plans to utilize other hallucinogens for treatment upon their approval. Due to recently closed deals, Enthea expanded out to the point of now offering this coverage nationwide.

I reported last year that Enthea partnered with Dr. Bronner’s, making for the first offering of ketamine therapy as a part of worker healthcare. In late summer, Enthea released a progress report indicating that so far these ketamine treatments have been used by a small percentage of the staff, and provided positive benefits.

As per its report: 7% of Dr. Bronner’s staff utilized ketamine services since their initiation into the healthcare program. Initial reporting indicates that workers experiencing PTSD, general anxiety issues, or major depressive disorder, reported improvements of 86%, 65%, and 67% respectively. While no one said ketamine treatments will help everyone; imagine the possible improvement if these percents are relevant across an entire population’s use.

Employment healthcare options to treat stress and depression
Employment healthcare options to treat stress and depression

Now, Enthea is expanding its coverage further with new deals. According to Live5News, Enthea’s new deals are with the clinic chains Skylight Psychedelics and Innerwell. Both provide ketamine therapy throughout the US, which expands Enthea’s reach. The first, offers treatments in its Skylight Journey Centers, as well as at-home treatments, for those who prefer not to be in a clinic.

The second, Innerwell, provides therapy as a combination approach; involving a team of holistic therapists, along with standard medical approaches, and coaching. The company seeks to use data and patient outcomes, to drive the direction of treatment. This company also provides in-house and at-home services.

What does a company need to do to offer these services to their workers? Simply add it on to the plan, as they would for dental or vision coverage. All the employer must do, is sign up. Enthea handles everything else, including: a providers network, established policy which includes standards of care, treatment authorization and reimbursement for companies, educational services, and specifically tailored plans for a company’s precise needs.

Sherry Rais, Enthea’s co-founder and CEO stated, “Nationwide availability represents a pivotal moment in accomplishing Enthea’s mission of helping employers with workplace mental health challenges. Our services at Enthea make it easy on businesses to embrace this safe and effective treatment offering for their employees and we’re proud to have the potential to impact the millions of people in the US living with mental health conditions.”

The problem of workplace depression

How necessary is it to find better treatments and services for employees? I suppose that’s a matter of opinion. Some people love getting up every day to navigate their work environment. Others cringe at the sound of each alarm; sickened by another day of office politics, possible bulling by bosses or peers, long work days away from family, and feelings of being overworked and underpaid. Let’s take a closer look at the issue of workplace depression.

According to an American Psychological Association 2021 Work and Well-being Survey, 59% of respondents said that just within the past month, their work was impacted by work-place stress. A huge 87% said they believe that better handling by employers could reduce mental health issues in workplace environments.

Employers can institute a benefits policy they think is best for workers
Employers can institute a benefits policy they think is best for workers

Further to this, a CDC informational page on workplace depression, states that depression causes a loss of 200 million working days a year, combined. This overall costs employers approximately $17 – $44 billion yearly. Depression issues lead to missed work days, and simply not being present or productive while at work.

According to NORC in conjunction with University of Chicago’s National Safety Council; “employers that support mental health see a return of $4 for every dollar invested in mental health treatment.” This indicates that if employers are more thoughtful of their employee’s issues and mindsets; they can improve their own spending, and essentially, waste less.

What jobs cause the most stress? According to the CDC, 10.8% of personal care and service workers report workplace stress, making for the highest stress jobs. Food industry workers clock in at 10.3% who experience stress. Lower stress jobs such as engineering, architecture, and surveying, report that only about 4.3% of employees are stressed.

Life, physical, and social science workers also experience lower stress, at a rate of 4.4%; the same as installation, maintenance, and repairmen. Of course, not everyone understands the concept of their own depression, or wants to admit to it in any context, given the massive stigma attached. I expect these numbers are actually incredibly low for these reasons of possible skewed reporting.

The National Safety Council, for its part, contributes that mental health issues among workers accounts for an extra $3,000 yearly per worker in healthcare services; and that the cost for days lost to stress-related issues is $4,783 per employee, every year. It’s a bad cycle. Stress issues lower worker ability, which means employers lose out as well. Perhaps this makes them then put more stress on employees.


So far, the broad use of ketamine therapy for workplace employees is still a new and growing concept. With the help of Enthea, however, it can now be utilized by any employer in the US who wants to offer ketamine, and other psychedelic treatments, as they become available. If you are an employer, and you want to offer your employees these services, go here. And if you’re an employee who wants coverage of these services; you’ll soon have a growing number of workplaces offering it. Just hold tight.

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