Tag: mental health

80 Bipartisan Lawmakers Push FDA To Seriously Consider Approving MDMA-Assisted Therapy

A bipartisan and bicameral coalition of congressional lawmakers is expressing urgency to the federal government as it looks into the possibility of authorizing MDMA-assisted therapy, particularly as it concerns veterans with severe mental health conditions.

A total of 80 members of Congress—including 19 senators and 61 representatives from the House—sent separate letters to the Biden administration and the head of the Food and Drug Administration (FDA) this past week, urging serious consideration of approving the psychedelic as a treatment option for post-traumatic stress disorder (PTSD).

MDMA is “one of the most promising and available options to provide reprieve for veterans’ endless PTSD cycle,” the Senate letter says, noting that FDA has already designated it as a breakthrough therapy.

This comes about a month after an FDA advisory panel rejected an application to authorize MDMA-assisted therapy. Bipartisan lawmakers separately staged an event at the U.S. Capitol calling for the MDMA approval and also launched an art installation memorializing military veterans who die by suicide.

“FDA should remain firmly anchored in scientific evidence and data when evaluating new treatments,” the new letter, led by Sens. Michael Bennet (D-CO), Thom Tillis (R-NC), Kyrsten Sinema (I-AZ) and Rand Paul (R-KY), says. “The potential for groundbreaking advancements in PTSD treatment is within reach, and we owe it to our veterans and other affected populations to review these potentially transformative therapies based on robust clinical and scientific evidence.”

Keep reading

Older Patients Using Medical Cannabis ‘Experience Considerable Improvement In Health And Well-Being,’ Study Finds

A new study on the impacts of medical marijuana on older adults finds that cannabis-based products may provide multiple therapeutic benefits for the demographic, including for health, well-being, sleep and mood.

Authors also observed “sizable reductions in pain severity and pain interference among older aged patients [reporting] chronic pain as their primary condition.”

The research, published this week in the journal Drugs and Aging, is meant to address what authors call “a general paucity of high quality research” around cannabis and older adults “and a common methodological practice of excluding those aged over 65 years from clinical trials” at a time when older patients are increasingly turning to medical marijuana for relief.

“International evidence that older individuals may be the fastest-growing increase in the use of medical marijuana, coupled with their frequent exclusion from controlled trials, indicates a growing need for real-world evidence to assess the effectiveness and safety of these drugs for older individuals,” the paper says.

Keep reading

Arizona’s Democratic Governor Vetoes Bill To Legalize Psilocybin Service Centers

The Democratic governor of Arizona has vetoed a bill to legalize psilocybin service centers where people could receive the psychedelic in a medically supervised setting.

Less than a week after lawmakers gave final approval to the legislation, Gov. Katie Hobbs (D) rejected it on Tuesday, arguing that while the psychedelic may hold therapeutic potential, “we do not yet have the evidence needed to support widespread clinical expansion.”

“Arizonans with depression and PTSD deserve access to treatments that may be seen as outside the mainstream, but they should not be the subject of experiments for unproven therapies with a lack of appropriate guardrails,” the governor said in a veto message.

She also said that the bill’s estimated cost is $400,000 per year, which wasn’t accounted for in the budget.

Under the now-vetoed legislation, the Department of Human Services (DHS) would have been authorized to license psilocybin-assisted therapy centers in the state, where trained facilitators could have administered the psychedelic.

The measure would have significantly expanded on Arizona’s existing research-focused psychedelics law that provides $5 million in annual funding to support studies into psilocybin therapy.

Hobbs cited that research funding in her statement, saying the goal is to “ensure that those who seek psilocybin treatment are doing so confidently and safely under proper supervision of qualified professionals with documented and verified research to support the treatment.”

She said that money “will be allowed to continue with this year’s budget,” with a separate funding bill she signed into law on Tuesday protecting those dollars, which are exempt from lapsing appropriations provisions.

The vetoed proposal, meanwhile, would have established an Arizona Psilocybin Advisory Board, comprised of members appointed by the governor and legislative leaders. Representatives of the attorney general’s office and DHS, as well as military veterans, first responders, scientists with experience with psilocybin and physicians would have been among the members.

The board would have been responsible for establishing training criteria for psilocybin service center staff, making recommendations on the implementation of the law, and studying the science and policy developments related to psychedelics.

Sen. T. J. Shope (R), the bill’s sponsor, told The Center Square that the veto is a “disappointing result after months of hard work and the overwhelming bipartisan support this received in both houses of the Legislature this year.”

The senator added that if lawmakers were still in session, he’d be pushing for a vote to override the veto, but he’ll have to “settle for trying again next year.”

Keep reading

New Jersey Panel Approves Amended Psilocybin Bill, Removing Broad Legalization To Focus On Therapeutic Program

A New Jersey Senate panel approved an amended psilocybin bill on Thursday, advancing substitute language that removed earlier provisions that would have broadly legalized possession, use and cultivation by adults in order to instead focus exclusively on therapeutic access to the psychedelic.

The Senate Health, Human Services and Senior Citizens Committee voted 6–2 to release the bill, S.2283, sponsored by Senate President Nick Scutari (D) and others.

Initially, the legislation was introduced this year in identical form to what Scutari proposed last session—a plan that included personal legalization provisions, which the recent amended version takes out. Those components would have made it legal for adults to “possess, store, use, ingest, inhale, process, transport, deliver without consideration, or distribute without consideration, four grams or less of psilocybin.”

The new measure would nevertheless significantly expand on legislation Scutari introduced in late 2020 to reduce penalties for possession of up to one ounce of psilocybin. That reform that was signed into law by Gov. Phil Murphy (D) in 2021.

In its amended version, the bill would charge the Department of Health (DOH) with licensing and regulating the manufacture, testing, transport, delivery, sale and purchase of psilocybin. There would be five license types: manufacturer, service center operator, testing laboratory, facilitator and psilocybin worker.

A Psilocybin Advisory Board would establish qualifying medical conditions for use, propose guidelines for psilocybin services and dosage, craft safety screenings and informed consent practices and oversee facilitator education, training and conduct.

Keep reading

How therapy has turned generation of Americans into ‘victims’ and may be CAUSING depression epidemic, according to top experts

There has been a big push to get more Americans talking about their feelings in recent decades.

But now experts are starting to wonder if the widespread use of therapy may be having the opposite effect and actually fueling America’s depression crisis.

They argue the treatment, however well-intentioned, can instill a ‘victim’ mentality where people become hyper-focused on their feelings and less engaged with the world around them, making them more depressed.

Around a quarter of US adults said they had visited a therapist or psychiatrist in 2022, which is twice as high as 20 years ago and far higher than the around 3 percent in the UK.

Therapy speak has become so common it has permeated mainstream culture in the US. Clinical words used during counseling like ‘gaslighting’, ‘trauma’ and ‘microaggressions’ have become household terms.

Professor Robert Dingwall, a social scientist and adviser to the UK government, told DailyMail.com that looking on at the situation in America, there is a concern among sociologists that people are being referred to therapy at the slightest sign of hardship in their life. 

‘There is a tendency to medicalize everyday problems in pursuit of commercial interests,’ he said, whether it be rejection from a partner or a failed job interview.

‘This is something that people have been saying for 50 or 60 years, a concern that’s been expressed by both psychiatrists and sociologists.’ 

This fosters a victim mentality, said Shawn Smith, a clinical psychologist based in Colorado.

Keep reading

New Study Finds One Dose of LSD Could Effectively Treat Anxiety in Many Patients

After years of criminalization and marginalization, scientists have begun looking at LSD’s medical benefits more closely, so much so that the Food and Drug Administration just issued a groundbreaking stamp of approval. 

Biopharmaceutical company Mind Medicine announced March 7 that the FDA has awarded “breakthrough therapy” status to its trial of patients using MM120 (lysergide D-tartrate) to treat anxiety. MindMed chief medical officer Daniel Karlin explained what the trial approval means going forward. “A breakthrough designation is a recognition that a drug has demonstrated evidence of clinical efficacy in meeting an unmet medical need with morbidity and mortality associated with it,” he told CNN. The move allows the FDA to “engage more closely in drug development” and speeds up the road to final approval as the agency is involved throughout the process. 

MM120 is the codename for MindMed’s lysergide D-tartrate compound, which resembles and delivers similar effects to lysergic acid diethylamide, known more commonly as LSD. In its ongoing trial, which kicked off in 2022, MindMed has so far found that a single dose of MM120 led to a 48-percent rate of remission from generalized anxiety disorder after 12 weeks following the drug’s administration. Scientists also noted significantly improved clinical signs of generalized anxiety disorder among 65 percent of patients within three months. 

“The clinical improvement for many patients was more than double what we see with today’s standard of care,” Karlin said. “This occurred at all levels of anxiety, from moderate all the way up to severe.”

Keep reading

Single LSD dose provides lasting anxiety relief: Research

The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy status to an LSD formula to treat generalized anxiety disorder after an initial study has shown that a single dose of the drug could provide lasting relief.

The LSD therapy developed by Mind Medicine Inc. (MindMed) must still go through the standard FDA approval process and will soon enter Phase 3 clinical trials.

The study that prompted FDA advancement found the drug was “generally well-tolerated with most adverse events rated as mild to moderate, transient and occurring on dosing day, and being consistent with expected acute effects of the study drug,” according to a release on the findings.

The most common adverse effects on the initial “dosing day” — or when patients were first given the drug — included hallucinations, euphoric mood, abnormal thinking, headache, dizziness and nausea, among others.

The company plans to meet for an update with the FDA in the coming months and begin an expanded clinical program in the second half of the year.

MindMed, a pharmaceutical company focused on developing psychedelic drugs into medicines, has spent years researching possible medicinal uses for LSD, an illicit drug that has never been approved for medicinal use. The specific LSD formula from the study is dubbed MM120.

Keep reading

Analysis: Cannabis Products Provide Sustained Improvements In Sleep Quality For Patients With Insomnia

Insomnia patients who consume cannabis products report sustained improvements in their sleep quality, according to data published in the journal Brain & Behavior. 

British investigators assessed the safety and efficacy of plant-derived cannabis products (either oils, flower, or a combination of both) in over 60 patients enrolled in the UK Medical Cannabis Registry. Cohort participants possessed a doctor’s authorization to access cannabis products. (Since 2018, specialists have been permitted to prescribe cannabis-based medicinal products to patients unresponsive to conventional medications.) Authors assessed the efficacy of cannabis at one, three, and six months.

Researchers reported that cannabis products were “well tolerated” and that they were associated with better sleep, reduced anxiety, and greater quality of life. 

They concluded: “More than 40 percent of participants who completed each PROM [patient-reported outcome measure] round reported clinically significant improvement in their sleep quality at each time period. These results show that initiation of CBMP [cannabis-based medicinal products] therapy was associated with improvements in those patients who had previously failed to respond to currently licensed treatments for insomnia.”

Keep reading

New Mexico Senate Passes Psilocybin Therapy And Research Resolution In Unanimous Vote

The New Mexico Senate has unanimously approved a bipartisan resolution requesting that state officials research the therapeutic potential of psilocybin and explore the creation of a regulatory framework to provide access to the psychedelic.

The body voted 37-0 to pass the measure from Senate Minority Whip Craig Brandt (R) and Sen. Jeff Steinborn (D).

The action came days after the Health and Public Affairs Committee had approved the legislation, also unanimously.

As “memorial” legislation, the proposal isn’t binding. Rather, it would represent a formal request for the state Department of Health to “study the efficacy of using psilocybin mushrooms for therapeutic treatments and the establishment of a program for psilocybin mushrooms to be used for therapeutic medical treatments.”

The whereas section of the resolution cites various studies supporting the therapeutic benefits of psilocybin for conditions such as major depression and substance misuse, while pointing out that the federal Food and Drug Administration (FDA) has designated the psychedelic as a “breakthrough therapy.”

To that end, the measure states that the health department should look into “necessary statutory or regulatory framework for developing” a state-level psilocybin program.

Keep reading

New Mexico Senate Committee Unanimously Approves Psilocybin Therapy And Research Resolution

A New Mexico Senate committee has unanimously approved a bipartisan resolution requesting that state officials research the therapeutic potential of psilocybin and explore the creation of a regulatory framework to provide access to the psychedelic.

The Senate Health and Public Affairs Committee voted 7-0 to pass the resolution from Senate Minority Whip Craig Brandt (R) and Sen. Jeff Steinborn (D) on Saturday.

As “memorial” legislation, the bicameral proposal wouldn’t be binding. Rather, it would represent a formal request for the state Department of Health to “study the efficacy of using psilocybin mushrooms for therapeutic treatments and the establishment of a program for psilocybin mushrooms to be used for therapeutic medical treatments.”

The whereas section of the resolution cites various studies supporting the therapeutic benefits of psilocybin for conditions such as major depression and substance misuse, while pointing out that the federal Food and Drug Administration (FDA) has designated the psychedelic as a “breakthrough therapy.”

To that end, the measure states that the health department should look into “necessary statutory or regulatory framework for developing” a state-level psilocybin program.

“This can help people very potentially, and so what we’re trying to do in a bipartisan way is ask the Department of Health to recognize that we want them to get going to start looking at this,” Steinborn said during Saturday’s committee hearing.

The measure “really seeks to expand therapeutic options for New Mexicans,” he said.

Keep reading