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Psychedelic Therapy in Australia Likely To Cost Thousands
Psychedelic treatment could cost $25,000 to $30,000 in Australia.
Patients in Australia will soon have legal access to the psychedelic drugs psilocybin and MDMA under a plan announced by regulators last month. But with no approved source of the drug available to therapists, patients will likely face bills in the tens of thousands of dollars to obtain the promising treatment.
Last month, the Therapeutic Goods Administration (TGA), the Australian government’s medicine and therapeutic regulatory agency, announced that qualified psychiatrists will be able to prescribe the psychedelic drugs psilocybin and MDMA for the treatment of certain mental health conditions beginning later this year. But the agency has not approved any products containing the promising psychedelic drugs, leaving mental health professionals to source the drugs themselves. Without a government subsidy to help cover the cost of the medications, psychiatrists estimate that patients will have to pay as much as AU$25,000 (nearly $17,000) and more out of pocket for psychedelic-assisted therapy.
“For the actual patient, it might be $25,000, $30,000 for a treatment,” said Dr. Stephen Bright, a senior lecturer at Edith Cowan University and director of the charity Psychedelic Research In Science & Medicine.
“I honestly don’t think, for the next 12 to 18 months post July 1, that these treatments will be very widely available at all,” he added. “The tight controls of therapy mean there are very few psychologists who put their hand up. There will be a few clinics that open up, but I don’t think we’re going to see the floodgates open.”
Dr. Paul Liknaitzky, the head of the Clinical Psychedelic Lab at Monash University, revealed last month that he and other mental health professionals will be partnering with investors to open a psychedelic-assisted therapy clinic in Melbourne. But training requirements for therapists and detailed guidelines for such therapy have yet to be issued by government regulators.
“There is a lack of detailed clarity from the TGA to help us understand how it’s going to roll out. We are concerned but cautiously optimistic,” he said.
Liknaitzky said that he and his colleagues will help establish protocols that set high standards for ethical and effective psychedelic-assisted therapy. But he warned that the high cost of treatment might make the treatment inaccessible to most Australians.
“Sensible and safe treatment approaches, based on decades of best-practice development, will include considerable screening, psychotherapy and other support. A typical course of treatment, spanning a few months, may be in the order of $25,000, plus or minus $10,000,” he said. “If it turns out to be cost-effective, it will be in the government’s interest to fund it.”
Psychedelic-Assisted Therapy Shows Promise
Ongoing research has shown that psilocybin, the primary psychoactive compound in magic mushrooms, has the potential to be an effective treatment for several serious mental health conditions, including PTSD, major depressive disorder, anxiety and substance misuse disorders. A study published in 2020 in the peer-reviewed journal JAMA Psychiatry found that psilocybin-assisted psychotherapy was a quick-acting and effective treatment for a group of 24 participants with major depressive disorder.
Separate research published in 2016 determined that psilocybin treatment produced substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer. And in 2021, a study published in the journal NatureMedicine determined that MDMA, commonly known as ecstasy, is a highly efficacious and safe treatment for individuals with severe PTSD.
But Professor Chris Langmead of the Monash Institute of Pharmaceutical Sciences says that it is unlikely that public health agencies will cover the cost of such treatment until further research including a cost-benefit analysis has been completed.
“We’re trying to get a groundswell of research and funding so we can do the research, clinical studies and practice rollout [to ensure] that this is not purely a market-led solution where the most disadvantaged populations are missing out,” he said. “The TGA has put Australia at the forefront of the world and we really need to take the opportunity and make the most of it.”
University of Melbourne associate professor Gillinder Bedi said that a shortage of clinical staff trained in psychedelic-assisted therapy will also make the treatment difficult for patients to obtain.
“The infrastructure will get set up. There will be clinics. But the problem is we don’t have staff. People can’t even see psychiatrists under normal conditions,” she said. “If you put two clinical psychologists in a room for eight hours, at a [Medicare] billing rate of $120 an hour – which is not what people charge, they charge $200 to $300 – you have an enormously expensive treatment. I think it could get higher [than $25,000].
“No matter which way you look at it, it will take time away from other treatments and cost a whole bunch of money. It’s unclear who will foot the bill, some organizations are trying to set up philanthropic funding,” Bedi added. “But it’s going to be for people with money, in the initial stages at least.”
Source: https://hightimes.com/news/psychedelic-therapy-in-australia-likely-to-cost-thousands/
New Mexico regulators fined a cannabis operator nearly $300,000 and revoked its license after the company allegedly created fake reports in the state’s traceability software.
The New Mexico Cannabis Control Division (CCD) accused marijuana manufacturer and retailer Golden Roots of 11 violations, according to Albuquerque Business First.
Golden Roots operates the The Cannabis Revolution Dispensary.
The majority of the violations are related to the Albuquerque company’s improper use of BioTrack, which has been New Mexico’s track-and-trace vendor since 2015.
The CCD alleges Golden Roots reported marijuana production only two months after it had received its vertically integrated license, according to Albuquerque Business First.
Because cannabis takes longer than two months to be cultivated, the CCD was suspicious of the report.
After inspecting the company’s premises, the CCD alleged Golden Roots reported cultivation, transportation and sales in BioTrack but wasn’t able to provide officers who inspected the site evidence that the operator was cultivating cannabis.
In April, the CCD revoked Golden Roots’ license and issued a $10,000 fine, according to the news outlet.
The company requested a hearing, which the regulator scheduled for Sept. 1.
At the hearing, the CCD testified that the company’s dried-cannabis weights in BioTrack were suspicious because they didn’t seem to accurately reflect how much weight marijuana loses as it dries.
Company employees also poorly accounted for why they were making adjustments in the system of up to 24 pounds of cannabis, making comments such as “bad” or “mistake” in the software, Albuquerque Business First reported.
Golden Roots was fined $298,972.05 – the amount regulators allege the company made selling products that weren’t properly accounted for in BioTrack.
The CCD has been cracking down on cannabis operators accused of selling products procured from out-of-state or not grown legally:
- Regulators alleged in August that Albuquerque dispensary Sawmill Sweet Leaf sold out-of-state products and didn’t have a license for extraction.
- Paradise Exotics Distro lost its license in July after regulators alleged the company sold products made in California.
Golden Roots was the first alleged rulebreaker in New Mexico to be asked to pay a large fine.
Source: https://mjbizdaily.com/new-mexico-cannabis-operator-fined-loses-license-for-alleged-biotrack-fraud/
Four marijuana companies, including a multistate operator, have filed a lawsuit against U.S. Attorney General Merrick Garland in which they allege the federal MJ prohibition under the Controlled Substances Act is no longer constitutional.
According to the complaint, filed Thursday in U.S. District Court in Massachusetts, retailer Canna Provisions, Treevit delivery service CEO Gyasi Sellers, cultivator Wiseacre Farm and MSO Verano Holdings Corp. are all harmed by “the federal government’s unconstitutional ban on cultivating, manufacturing, distributing, or possessing intrastate marijuana.”
Verano is headquartered in Chicago but has operations in Massachusetts; the other three operators are based in Massachusetts.
The lawsuit seeks a ruling that the “Controlled Substances Act is unconstitutional as applied to the intrastate cultivation, manufacture, possession, and distribution of marijuana pursuant to state law.”
The companies want the case to go before the U.S. Supreme Court.
They hired prominent law firm Boies Schiller Flexner to represent them.
The New York-based firm’s principal is David Boies, whose former clients include Microsoft, former presidential candidate Al Gore and Elizabeth Holmes’ disgraced startup Theranos.
Similar challenges to the federal Controlled Substances Act (CSA) have failed.
One such challenge led to a landmark Supreme Court decision in 2005.
In Gonzalez vs. Raich, the highest court in the United States ruled in a 6-3 decision that the commerce clause of the U.S. Constitution gave Congress the power to outlaw marijuana federally, even though state laws allow the cultivation and sale of cannabis.
In the 18 years since that ruling, 23 states and the District of Columbia have legalized adult-use marijuana and the federal government has allowed a multibillion-dollar cannabis industry to thrive.
Since both Congress and the U.S. Department of Justice, currently headed by Garland, have declined to intervene in state-licensed marijuana markets, the key facts that led to the Supreme Court’s 2005 ruling “no longer apply,” Boies said in a statement Thursday.
“The Supreme Court has since made clear that the federal government lacks the authority to regulate purely intrastate commerce,” Boies said.
“Moreover, the facts on which those precedents are based are no longer true.”
Verano President Darren Weiss said in a statement the company is “prepared to bring this case all the way to the Supreme Court in order to align federal law with how Congress has acted for years.”
While the Biden administration’s push to reschedule marijuana would help solve marijuana operators’ federal tax woes, neither rescheduling nor modest Congressional reforms such as the SAFER Banking Act “solve the fundamental issue,” Weiss added.
“The application of the CSA to lawful state-run cannabis business is an unconstitutional overreach on state sovereignty that has led to decades of harm, failed businesses, lost jobs, and unsafe working conditions.”
Alabama regulators are targeting Dec. 1 to award the first batch of medical cannabis business licenses after the agency’s first two attempts were scrapped because of scoring errors and litigation.
The first licenses will be awarded to individual cultivators, delivery providers, processors, dispensaries and state testing labs, according to the Alabama Medical Cannabis Commission (AMCC).
Then, on Dec. 12, the AMCC will award licenses for vertically integrated operations, a designation set primarily for multistate operators.
Licenses are expected to be handed out 28 days after they have been awarded, so MMJ production could begin in early January, according to the Alabama Daily News.
That means MMJ products could be available for patients around early March, an AMCC spokesperson told the media outlet.
Regulators initially awarded 21 business licenses in June, only to void them after applicants alleged inconsistencies with how the applications were scored.
Then, in August, the state awarded 24 different licenses – 19 went to June recipients – only to reverse themselves again and scratch those licenses after spurned applicants filed lawsuits.
A state judge dismissed a lawsuit filed by Chicago-based MSO Verano Holdings Corp., but another lawsuit is pending.
Source: https://mjbizdaily.com/alabama-plans-to-award-medical-cannabis-licenses-dec-1/
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