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FDA sidesteps MDMA controversy at PTSD meeting, but public pushes back
Published
1 week agoon
A recent U.S. Food and Drug Administration meeting on post-traumatic stress disorder treatments has reignited, within more official channels, the debate over the agency’s decision last month to delay approval of privately-owned Lykos Therapeutics‘ MDMA-assisted therapy.
The Sept. 6 hybrid public meeting, hosted by the Reagan-Udall Foundation for the FDA, drew experts, advocates and critics to discuss how to move forward advancing PTSD treatment. While the official agenda skirted the recent MDMA decision, public comments and a subsequent press briefing brought a spotlight back on the issue.
The FDA’s decision last month sent shockwaves through the psychedelic therapy community. Many close to the issue, including Multidisciplinary Association for Psychedelic Studies (MAPS), have continued to tout that MDMA-assisted therapy had shown promising results in clinical trials with PTSD patients.
Dr. Michael Mithoefer, former senior medical director at MAPS Public Benefit Corporation, said in a follow-up press briefing with reporters that “about two-thirds of people lost the diagnosis of PTSD” after treatment.
Despite so, the FDA ended up requesting more information before granting approval for Lykos’ proposed new drug, a move that has drawn criticism from various groups. Participants on the Friday FDA meeting call didn’t mince words during the public comment period.
“In my opinion, the FDA’s review of MDMA-assisted therapy failed,” said Dr. Robert M. Grant, a professor of medicine at the University of California, San Francisco. Grant has served on FDA advisory committees for four new drug applications and is trained in MDMA-assisted psychotherapy.
Grant said the agency “provided inconsistent guidance, did not adhere to previously given instructions, and did not offer context to its external advisors.”
He also stressed the “critical” need for better PTSD treatments, noting that “existing therapies reach less than 5% of the impacted population.”
Regarding the clinical trials, Grant defended the methodology used, saying he believed that the use of “blinded adherence raters as a primary outcome in MDMA trials is rigorous and best practice.” He added that alternative blinding methods suggested by critics “have been tried and rejected based on evidence.”
“The FDA missed an opportunity to provide clear guidance on how to move forward,” he said.
FDA call
The meeting’s official presentation largely avoided direct discussion of the MDMA decision, instead focusing on the wider scene for PTSD treatment and research, as well as the condition’s references in history’s past.
Dr. Paula Schnurr, executive director of the National Center for PTSD, declared on the call that the U.S. Department of Veterans Affairs is also “preparing for the potential future implementation of psychedelic treatments by supporting and conducting research on medications such as MDMA and psilocybin for treating PTSD and depression.”
She called psychedelic medicine “one promising avenue.”
However, the brief acknowledgments did little to address questions surrounding the FDA’s recent decision.
It was during the public comment period that the real-world impact of the FDA’s decision grabbed the spotlight. Veterans, PTSD survivors, and researchers took turns sharing personal experiences and expressing frustration with the delay in approving MDMA-assisted therapy.
The public comments painted the growing disconnect between the FDA’s cautious approach and more insistent needs expressed by potential beneficiaries of MDMA-assisted therapy.
“More than 150,000 veterans have died from suicide – 15 times the number killed in combat,” said Jesse Gould, founder of the Heroic Hearts Project. “This is a national crisis, and we need to act urgently.”
“Veterans are already traveling overseas for life-saving psychedelic therapies because they know these treatments work. The VA itself is running clinical trials on MDMA, and it supports these therapies. We cannot wait years for the FDA to catch up while more veterans die,” he added.
Others did not supported immediate approval, however. Dr. Nese Devenot, a senior lecturer at Johns Hopkins University with expertise in psychedelic bioethics, cautioned against lowering research standards or promoting false hope.
“Industry lobbyists have exerted pressure to lower these standards, and organizations funded by pharmaceutical companies have played a role in this push,” Devenot said. “The recent FDA decision to reject MDMA-assisted therapy came with new requirements, such as ensuring that any therapeutic adjuncts to drugs are evidence-based psychotherapies.”
Dr. Michael Abrams, a senior researcher with Public Citizen, defended the FDA’s decision. He cited concerns about unblinding bias in trials, lack of physiological data and the need to differentiate between drug and therapy effects.
“While these drugs clearly have powerful brain-based effects, evidence regarding their precise and safe actions in treating PTSD remains incomplete,” Abrams said.
“It’s important that psychedelic trials differentiate between the effects of the drug and the non-drug intervention, such as therapy. Both the drug and placebo groups in the MDMA trial showed positive effects, indicating that intensive talk therapy alone is beneficial. This offers hope for non-drug approaches as well,” he added.
The FDA, for its part, defended its stance.
“It’s essential that we collect data on the safety and effectiveness of these treatments because patients with PTSD, like all patients, deserve safe and effective options,” said Dr. Marta Sokolowska, deputy center director for substance use and behavioral health in the FDA’s Center for Drug Evaluation and Research.
MAPS’ follow-up call
While the FDA largely avoided direct discussion of the recent MDMA decision, a subsequent press briefing organized by MAPS circled in on the issue.
The FDA call, “illustrated the growing public interest in psychedelic-assisted therapies, with nearly every speaker discussing their potential in a meeting that wasn’t specifically about psychedelics,” according to Betty Aldworth, director of communications for MAPS.
Aldworth noted, “Eighty members of Congress, the Veterans Affairs Administration, trauma experts, patient advocates, and 14 of 23 stakeholders who gave oral testimony agree that the existing evidence base for psychedelic-assisted therapies merit widespread, and growing, support.”
Aldworth didn’t mince words about the impact of the FDA’s delay, and said, “It has been heartbreaking, not just for MAPS, but for the thousands of people still suffering from PTSD who have reached out to us, desperate for effective treatment.”
She claimed that the delay is pushing people towards the underground psychedelics market in search of medicine.
“Many people are using psychedelics in unregulated settings because they see them as their last chance to heal,” she said on the call.
Only two FDA-approved drugs for PTSD are available, and they are not effective for all patients, according to Dr. Bessel van der Kolk, a pioneering trauma researcher.
“MDMA helps people revisit dark places and say, ‘This happened, but it wasn’t my fault.’ Prozac doesn’t cause that,” he said on the call.
To another end, one researcher on the MAPS call stressed the need for more inclusive diagnostic criteria.
“The DSM-5 diagnostic criteria are highly suspect, especially when it comes to racial trauma,” Dr. Darron Smith said. “We need more holistic tools to evaluate healing and transformation, particularly for communities of color.”
MAPS outlined its next steps, including continuing Phase 3 clinical trials in addition to educating healthcare providers and policymakers. MAPS will also continue working with regulatory bodies, especially in states like Colorado and Oregon that are implementing their own regulated psychedelic treatment models.
“We are going to be putting a lot of our energies into the kinds of efforts that are going to provide access, regardless of what the FDA requires because the reality today is that many people are accessing these treatments,” Aldworth said.
Author: mscannabiz.com
MScannaBIZ for all you Mississippi Cannabis News and Information.
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Business
Florida’s Fluent responds to Reddit whistleblowers
Published
6 hours agoon
September 19, 2024
Cansortium Inc.’s (CSE: TIUM.U) (OTCQB: CNTMF) Fluent brand is facing fallout after an employee and others shared videos and images on social media allegedly showing poor growing conditions at its Tampa, Florida, cultivation facility, in addition to labor accusations.
A video, posted last week on Reddit’s r/FLMedicalTrees forum, appeared to show withering cannabis plants infested with aphids. The post quickly gained traction, bringing in more than 500 upvotes and nearly 300 comments.
“Ma’am this is an aphid farm, we feed our aphids live cannabis to keep them happy healthy and thriving!” the self-identified employee who uses the handle “Old_Length4214” wrote sarcastically in the comments section.
In response, Fluent CEO Robert Beasley confirmed that the video came from the company’s facility, but noted said there are quality control measures to address them.
“As preventing pests and pathogens entirely is not possible, we rely on our quality control program to catch these issues and eliminate them before they move on to the next stage of processing,” Beasley said in an email to Green Market Report on Tuesday.
Beasley outlined a multistep quality assurance process, including daily plant inspections, maintenance trimming and pre-harvest quality grading. He said that plants not meeting quality standards are removed or sent for extraction.
The CEO also addressed the challenges of growing cannabis in Florida’s climate.
“Cannabis does not like excess moisture in soil or in air, and Florida has both,” he explained, noting that these difficulties are factored into pricing and margins.
Another self-identified former employee, who said they worked at Fluent from October 2020 to May 2021, painted a wider picture.
Speaking on condition of anonymity, the former employee, who later worked in compliance for a cannabis testing lab, told GMR that these types of issues are problems for many operators in the state – but called out Fluent as one of the worst offenders.
“Every cultivation has issues … I remember swabbing MedMen’s (before Sunburn bought it) air vents, I remember Curaleaf had a huge issue with mold, Trulieve kept failing for pesticides even though their grow is indoors.”
The Florida Department of Health, which oversees the state’s medical marijuana program, did not respond to GMR’s requests for comment, but Beasley confirmed the agency conducted a routine quarterly inspection on Sept. 12.
“All Department inspections of medical marijuana treatment center facilities are unscheduled,” he said. That the inspection resulted in “one finding regarding waste logs, which the site team has corrected.”
While Beasley downplayed the issue to Green Market Report, the situation appears to have escalated internally. A self-described current Fluent employee, posting anonymously on Reddit as “smokechecklafleur,” described a tense work environment last Friday, two days after the original post.
“A large amount of my coworkers and myself included are considering leaving the company due to how bad things have gotten,” the employee wrote. They detailed new restrictions, including a ban on phones “whatsoever” at work and prohibitions on discussing the grow issues or a “random” visit from the state’s health department the day before.
“Morale is through the floor while management is scrambling to do damage control,” the employee added, “and we’ve been threatened with being terminated every day since the first post for more reasons than I can remember.”
The user also reported that four people had been terminated within an hour of their post.
“These are not new but rather an existing policy that was not being strictly enforced,” Beasley said about allegations that management is trying to stem information flow in response to the increased scrutiny.
He added, “The rationale is that it allows for greater efficiency and safety in the workplace environment. It also prevents incidents such as this where a former employee took pictures of plants being trimmed or disposed of and are claiming they represent the final product output.”
Regarding personnel changes, Beasley said, “We are not able to disclose the details of employment matters, however, we can confirm that if an individual violates Company policy by posting misleading and derogatory information about the Company online, it can lead to termination.”
The CEO said management’s planning a town hall meeting to discuss working conditions “in a professional and respectful setting.”
Author: mscannabiz.com
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Business
Missouri issues yet another cannabis recall, rolls back hemp ban
Published
10 hours agoon
September 19, 2024
Missouri cannabis regulators continued their scrutiny of the industry’s compliance this week with their fifth recall since the adult-use marijuana market launched – this time recalling more than 23,000 goods for improper safety testing – while also announcing that many intoxicating hemp goods will be exempt from a new law that initially banned most of the products.
The state Division of Cannabis Regulation issued the recall on Tuesday after discovering the relevant products “were not compliantly mandatory tested” by ClearWater Science, one of the state’s cannabis testing labs, according to the press release issued on Tuesday by the state Department of Health and Senior Services.
“DCR cannot verify compliance with health and safety requirements,” the agency said, in justifying the recall. There have been no adverse health incidents connected to the products in question, the DCR clarified.
The goods affected by the recall include a wide range of brands and products, including pre-rolled joints, flower, concentrates, vape cartridges and edibles.
It was not immediately clear if the goods in question will be allowed to undergo retesting in order to be legally sold at dispensaries, since there’s no immediate evidence that the products themselves were tainted in any way.
The latest recall follows several earlier parallel moves by the DCR, which ramped up its oversight on the adult-use and medical cannabis industry over the past year. The total of goods recalled is now near 200,000.
Also this week, an attorney for DHSS wrote in a letter to a hemp trade association that an executive order from Gov. Mike Parsons last month that attempted to ban intoxicating hemp goods would not apply to hemp-based products with THC.
“In regard to psychoactive cannabis products, the department will focus its efforts on the identification of ‘misbranded’ products,’” Richard Moore wrote to the Missouri Hemp Trade Association, which filed suit against the state last month over the ban.
“I trust that you understand that the consumption of these products may be dangerous,” Moore wrote to the hemp companies, “and that under no circumstances should they end up in the hands of Missouri’s children.”
Moore said his office would be only targeting goods that are “misbranded” to target kids, “for potential enforcement under the State’s Merchandising Practices Act,” the Independent reported.
“The department has no intention at this time to embargo additional psychoactive cannabis products as adulterated,” Moore wrote. “Further, within 30 days after referral to the attorney general’s office, the department will release all currently embargoed products and remove all embargo tags.”
The Missouri Hemp Trade Association reacted favorably to the news, which seems to settle for now what had been a legal tug-of-war between the governor and hemp businesses. A spokesperson told the Independent it wholeheartedly supports Moore’s move “to prosecute bad actors marketing counterfeit and misbranded hemp products to children.”
In other words, “Hemp sales are back on,” said an attorney for the trade group.
Author: mscannabiz.com
MScannaBIZ for all you Mississippi Cannabis News and Information.
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On the Site
Missouri issues yet another cannabis recall, rolls back hemp ban
The state’s Department of Health and Senior Services will focus its efforts on “misbranded” products rather than intoxicating ones.
Proposed California intoxicating hemp ban may wind up in court
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Washington DC moves toward gray market cannabis crackdown
City leaders want to ramp up enforcement on so-called I-71 shops.
EU initiative begins bid to open access to psychedelic therapies
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One week after Maine regulators recalled a handful of cannabis products for failing mold and yeast tests, it remains unclear how the contaminated products made it to the market. The recall, announced last week, impacts one strain of cannabis flower and three strains of pre-rolls, all of which were produced by Cannabis Cured, a cultivator and retailer headquartered in Fairfield.
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Author: mscannabiz.com
MScannaBIZ for all you Mississippi Cannabis News and Information.
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