Causes.com
| 3.28.23
Australia Becomes First Country To Approve Psychedelics as Medicine
Do you support legalizing psychedelics as medicine?
What’s the story?
- Australia made history as the first country to acknowledge psychedelics as a form of medicine, reclassifying them as “controlled substances” and making them available for use in managed medical settings.
- Australia’s federal medicine regulator, Therapeutic Goods Administration (TGA), declared that from July 1, 2023, qualified psychiatrists would be authorized to prescribe MDMA (also known as ecstasy) for post-traumatic stress disorder only and psilocybin (commonly known as magic mushrooms) for treatment-resistant depression only.
- Before psychiatrists can prescribe psychedelics, they must receive clearance from a Human Research Ethics Committee and be approved under the TGA's authorized prescriber program. To receive approval, psychiatrists must demonstrate their training and qualifications, patient selection criteria, evidence-based treatment protocols, patient monitoring procedures, and compliance with governance and reporting requirements.
- The TGA said in a statement:
“These measures are necessary because there is only limited evidence that the substances are of benefit in treating mental illnesses, and only in controlled medical settings.”
- Petra Skeffington, associate professor in clinical psychology at Murdoch University, said:
“With the potential for increased access to MDMA and psilocybin-assisted therapies, it is now critically important that high-quality therapist training be made available to promote safe therapeutic conditions when working with these medications.”
What does the research say?
- Ongoing global research and clinical trials show that psilocybin, the active ingredient in psychedelic mushrooms, can potentially treat certain mental health conditions, like depression, and can even be prescribed as an alternative to SSRIs.
- However, some researchers say more large-scale trials are needed. Katrin Preller, group leader at the University of Zurich, said:
“We still need to find out why these substances are helping patients i.e. the clinical mechanism of action is still unknown. In addition, we need larger trials. Furthermore, we need to find out what the optimal way is to conduct the non-pharmacological part of psychedelic-assisted therapy.”
What are the barriers to psychedelics in medicine?
- Scholars believe psychedelics were criminalized in the 1970s due to moral panic, which hindered research into their benefits and led to stigmatization. As a result, some therapists feel that offering psychedelic therapy may impact their professional reputation.
- In countries where psychedelics are prohibited, therapists who offer psychedelic harm reduction and integration therapy may be at risk of criminal prosecution. Additionally, there is a risk of being sued for malpractice if a client is harmed while using psychedelics, as the way of therapy is still new and thought to be lacking sufficient scientific evidence.
What is the legal status of psychedelics in the U.S.?
- The FDA categorizes most psychedelics, excluding ketamine, as Schedule I drugs, meaning they are federally prohibited.
- In the U.S., drug regulation is a shared responsibility between federal and state governments. While the Controlled Substances Act determines restrictions and penalties on a national level, states can legalize drugs classified as illegal under federal law, allowing them to experiment and advocate for change in drug policy.
- In 2020, Oregon became the first state to legalize psilocybin for medical treatment, provided it is administered under professional supervision. In Jan. 2023, Oregon legalized psychedelics more widely for personal, adult use.
- In other states, like Denver, Seattle, and Washington D.C., psilocybin is considered a decriminalized substance. State law enforcement will not arrest or prosecute individuals for using or possessing small amounts of psilocybin for personal use.
Do you support legalizing psychedelics as medicine?
- Laura Woods
(Photo credit: Wikimedia Commons)
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Using select medically conrolled and monitored use of psychedelics to treat medical conditions has been shown to be very effective for depression, PTSD, dealing with long term trauma and I am sure more related conditions.
This is not an authorization to use psychedelics recreationally - but restricted to select psychedelics with prescribed potentcy. The trials reported have been extremely efffectove. All required close monitoring by medical professionals wjho were present to monitor the patient while dosed and assure that they can guide them away form having a bad 'trip'.
Medical use only under educated Physiatric MD's guide.
This is what LSD started out to be and then it turned into a problem. I fear the same here
Australia has approved (2-3-23) use starting July 2023 under very tightly controlled circumstances. Prior to July it is only available in clinical trials like in the US. After that it ca be prescribed only if:
1) other treatments have failed
2) psychiatrists will need to be trained & certified
In the US, the state of Oregon approved (1-1-23) use of psilocybin for treatment resistant depression, Canada allows physicians to also prescribe it for treatment resistant depression, and the UK is following the Australian example before making changes. Clinical trials have been the way to access these drugs until approved by national regulatory authorities (FDA, NICE, TGA, etc)
The FDA granted Breakthrough Therapy status for psilocybin dose ranging studies for treatment-resistant depression (2018) in a multi-center Phase 2 dose ranging study (US, UK and Europe) and major depressive disorder (MDD) studies (2019) most of these studies are being conducted outside the US because of Psilocybin’s federal status as a Schedule I controlled substance instead of Schedule IV like sleeping pills. In order to change from Schedule I (no medical use) to Schedule IV (highly controlled use like sleeping pills) there needs to be published study results which there are.
JAMA Psychiatry (2021) 24 people with major depressive disorder, found that psilocybin-assisted therapy produced “large, rapid, and sustained antidepressant effects.”
New England Journal of Medicine (2021) people with moderate to severe depression showed that treatment with psilocybin was equally effective as treatment with a common antidepressant (escitalopram, brand name Lexapro).
Substances can be rescheduled through three legal pathways with legislative being the preferred way but precedence does exist for executive & judicial pathways.
1) legislative. Congress rescheduled psilocybin by amending the CSA using the precedence set by the Marijuana Opportunity Reinvestment and Expungement (MORE) cleared by the House Judiciary Committee as the evidence supporting psilocybin’s efficacy and low abuse potential is at least as strong as the data regarding cannabis, the legislative pathway should be a viable option.
2) Administrative. The CSA gives the federal attorney general power to schedule and reschedule substances or remove them from the controlled substances list through DEA or via presidential executive order compelling the DEA to reschedule psilocybin, or members of the public or government officials, could petition the DEA to act. While DEA & FDA approval are separate, the DEA usually requires FDA-approved therapies containing THC and DEA has denied several petitions to reschedule cannabis and would likely deny similar requests regarding psilocybin.
3) Judicial. Sue the DEA after it denies a scheduling petition like was done with cannabis providing a roadmap (review standards) for reviewing a petition and evaluating currently accepted use.
Johns Hopkins has been leading the way in research of potential uses with the 1st authorization to research in humans, and 1st federal grant. A successful phase 3 study for a proven use (depression, PTSD, smoking cessation, etc) is needed re-categorized from a schedule I drug—one with no known medical potential—to a schedule IV drug such as prescription sleep aids, but with tighter control to open up research to other organizations & people.
Johns Hopkins Research:
2000 US regulatory approval (IND) to research with psychedelics in healthy volunteers (phase 1 studies) who had no previous experience with psychedelics.
2006-2022 Publushed studies proof of concept studies (phase 2a) for major depressive disorder, decreases in suicide, palliative care, alcohol misuse, ptsd, mood disorders, Alzheimer’s, seizure, trauma, pharmacology, dose-ranging
2008 risk identification (overwhelming distress during drug action (‘bad trip’))
2014 Smoking cessation
2016 Anxiety in Cancer patients
2018 Need Successful completion of a phase 3 study for schedule I change to schedule IV
2018 FDA granted Breakthrough Therapy status to the ongoing work from COMPASS Pathways investigating psilocybin for treatment-resistant depression in a multi-center Phase 2 dose ranging study (US, UK and Europe).
2019 FDA granted psilocybin therapy a Breakthrough Therapy designation to accelerate studies to test efficacy in treating major depressive disorder (MDD).
2019 Alcohol abuse studies
2020 Ego control studies
2021 1st federal grant smoking cessation
Functional doctors in psychiatry like Amen clinic have also been reviewing research:
2021 study in JAMA Psychiatry involving 24 people with major depressive disorder, found that psilocybin-assisted therapy produced “large, rapid, and sustained antidepressant effects.”
2021 in The New England Journal of Medicine on people with moderate to severe depression showed that treatment with psilocybin was equally effective as treatment with a common antidepressant (escitalopram, brand name Lexapro).
"On February 3 this year, the Australian Therapeutic Goods Association (TGA) published its decision to authorize the use of MDMA for PTSD that has not responded to treatment, and psilocybin for treatment-resistant depression from July 2023. Both are substances that are, under any other circumstances, illegal."
"The main one is that the drugs are subjectively noticeable to participants in clinical trials.”
https://www.hopkinsmedicine.org/psychiatry/research/psychedelics-research.html
https://www.amenclinics.com/blog/the-pros-and-cons-of-psychedelics-in-psychiatry/
https://hopkinspsychedelic.org/publications
https://files.csp.org/Psilocybin/HopkinsHallucinogenSafety2008.pdf
https://www.hopkinsmedicine.org/news/media/releases/magic_mushrooms_help_longtime_smokers_quit
https://www.hopkinsmedicine.org/news/media/releases/hallucinogenic_drug_psilocybin_eases_existential_anxiety_in_people_with_life_threatening_cancer
https://journals.sagepub.com/doi/abs/10.1177/0269881119845793?journalCode=jopa
https://www.hopkinsmedicine.org/news/newsroom/news-releases/research-story-tip-psychedelic-drug-psilocybin-tamps-down-brains-ego-center
https://newatlas.com/science/psilocybin-major-depression-mdd-usona-breakthrough-therapy-fda/
https://www.scientificamerican.com/article/a-strategy-for-rescheduling-psilocybin/
https://www.medicalnewstoday.com/articles/mental-health-treatments-australia-oks-mdma-psilocybin-but-what-does-this-mean
I am for using any drugs that the good outweighs the bad side effects of they will Truly help people. But, that's the issue isn't it?!? Our Govt Agencies that were once trusted are no longer even believable. So, until we fix that problem I can not agree with allowing any New Drugs and I suggest that we do a Full Scale Analysis on All Drugs already approved to determine if they are actually Effective and Safe!!! We may consider hiring an Independent Team to perform this Review as our current Agencies are Not Trustworthy!!!
Another question that needs to be answered is Why have we not developed "Cures" for many diseases that have been being worked on for many, many years?!? One example is Diabetes!!!
"Scientists say that hair from a burial site in Menorca shows that ancient human civilisations used drugs derived from plants and bushes."
"They would have induced delirium and hallucinations, researchers found."
"The findings, published in the journal Scientific Reports, showed signs of human activity at the Es Càrritx cave, on the south-western side of Menorca."
"The cave houses more than 200 human graves, and is believed to have served as a ritual and funerary site for about 600 years, until 800BCE."
"Researchers found that the substances, which had the potential to be quite strong, may have been used as part of rituals held at the cave. These may have involved shamans "who were capable of controlling the side-effects of the plant drugs".
"Analysis of the locks, which had been dyed red during the ancient rituals and could have come from more than one person, detected three psychoactive substances."
"Along with atropine and scopolamine, which induce hallucinations, scientists found ephedrine, which boosts energy and alertness."
"Researchers also noted that containers were found in the cave with spiral motifs carved on the lids. Some scholars, the report said, have considered this to represent a person's "altered states of consciousness" while under the influence of hallucinogens."
https://www.bbc.com/news/world-europe-65211722
Great for severe depression.
Of course, providers must be held to the same standards as for any other medicine.
If it helps people who need it - whats the beef?
From what we know they can be very helpful.
if more people used psychedelics the world would be a better place.
I'm an Atheist, but the closest thing to a spiritual experience I ever had was on L.S.D. and it really helped my depression.
a ''trip'' can help people understand their connections to the planet, space, time, other people. it can make people more compassionate, more loving.
I oppose the war on drugs. adults should be informed, and use of any drug should be up to them.
Medical researchers must be allowed to evaluate objectively the medical advantages, as well as the risks ans side effects, of all proposed medications. Blindly banning things for no good scientific reason is bad policy, just as approving things for no good scientific reason is bad policy. Our decisions should be based upon FACTS and the best available scientific information. There is nothing about any plant, compound, or psychedelic substance that makes it a valid exception to this standard.
Prohibition does not accomplish anything but loss of civil liberties and increase in organized crime. It's not the government's business what one chooses to put in their body.
Psychedelics and marijuana have a bad reputation, but like a scalpel, they can do good or bad depending on how you use them. Just getting rid of them because some people abuse them is cutting off your nose to spite your face. It's better to regulate them as a controlled substance and give them to those they can help and study them than to simply ban them. Which I'd like to point out, we've already seen doesn't work.
Politicians need to stop thinking they're doctors, trying to control this.
I believe we have enough drugs floating around our country as is we do not need to make any legal. This will just make disreputable doctors that are now straddling the line between become legal dealers and we will have more addicts on the street then we now have.I would like for someone to explain to me why all the governments are trying to dope up all their citizens. Oh, wait I know the answer to that. Nevermind.
Medically supported only.
I would like to support this, but I'm sure it will be abused like medical marijuana was.
I will always support natural medicines opposed to Big Pharma drugs.
There is now enough evidence to support using psychedelics under treatment of a physician, so I support legalization for this use only.
We have a real mental health problem in our country, and too many people are suffering. If pyschedelics can be used in tandem with therapy under the care of a psychiatrist to relieve trauma, PTSD, or other mental diagnoses, then they should be.
I oppose recreational use of psychedelics, and these substances should not be widely available outside of a physician's office.