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The debate over the FDA’s decision to delay the approval of privately-owned treatments for post-traumatic disorder has resurfaced in more official channels. Lykos Therapeutics‘ MDMA-assisted therapy.

The hybrid public meeting on Sept. 6, hosted by the Reagan-Udall Foundation, brought together experts, advocates, and critics, to discuss how we can move forward in advancing PTSD treatments. The official agenda avoided the recent MDMA ruling, but public comments and a press briefing brought the issue back into focus.

The FDA’s decision made last month sent shockwaves throughout the psychedelic therapy world. Multidisciplinary Association for Psychedelic Studies, a group that is close to the issue has continued to claim that MDMA-assisted treatment showed promising results in clinical studies with PTSD patients.

Dr. Michael Mithoefer said that in a press briefing for reporters, he was the former senior medical director of MAPS Public Benefit Corporation. He stated that “about two thirds of people lost their diagnosis of PTSD after treatment.”

Despite this, the FDA requested more information before approving Lykos’ new drug proposal. This move has been criticized by various groups. During the public comment period, participants on the call for the FDA meeting held on Friday were not afraid to speak their minds.

Robert M. Grant is a professor of medicine and MDMA-assisted psychotherapy at the University of California San Francisco. He said, “In my opinion the FDA’s evaluation of MDMA assisted therapy failed.” Grant has served as a member of FDA advisory committees and is trained in MDMA assisted psychotherapy.

Grant said that the agency “provided inconsistent advice, did not adhere previously given instructions, or provided context to its external advisers.”

He also emphasized the “critical” necessity for better PTSD treatment, noting that the “existing therapies only reach less than 5% (or a small percentage) of the impacted populations.

Grant defended his methodology in the clinical trials. He said that he thought the use of “blinded raters” as a primary outcome for MDMA trials was rigorous and best practice.

He said that the FDA had missed an opportunity to give clear guidance about how to move forward.

FDA call

The official presentation of the meeting largely avoided direct discussions about the MDMA decision. Instead, it focused on the broader scene for PTSD research and treatment, as well as references to the condition in history.

Dr. Paula Schnurr is the executive director of the National Center for PTSD. She stated on the call that U.S. Department of Veterans Affairs “is also preparing for potential future implementation of psychedelic treatment by supporting and conducting studies on medications such MDMA and psilocybin for the treatment of PTSD and depression.”

She called psychedelics “one promising avenue.”

The FDA’s recent decision was not addressed in the short acknowledgements.

During the public comment period, the real-world impact was brought to the forefront. Veterans, PTSD sufferers, and researchers shared their personal experiences, expressing frustration at the delay in approving MDMA assisted therapy.

The public comments show a growing disconnect between FDA’s cautious approach, and the more insistent demands of potential MDMA-assisted treatment recipients.

Jesse Gould said, “More 150,000 veterans died by suicide – 15 more than the number of combat deaths,” founder of the Heroic Hearts Project. “This is a crisis of national proportions, and we must act immediately.”

“Veterans already travel overseas to receive life-saving psychedelic treatments because they know that these treatments work. The VA is conducting clinical trials on MDMA and supports these therapies. We cannot wait for years while more veterans are dying, he said.

Others, however, did not support immediate approval. Dr. Nese devenot, senior lecturer in bioethics at Johns Hopkins University, warned against lowering standards of research or promoting false hopes.

Devenot stated that “industry lobbyists and pharmaceutical companies funded organizations have exerted a lot of pressure to lower standards.” “The recent FDA rejection of MDMA-assisted therapies came with new requirements such as ensuring any therapeutic adjuncts are evidence-based psychotherapies.”

Dr. Michael Abrams is a senior researcher at Public Citizen and defended the FDA decision. He cited concerns over unblinding bias, lack of physiological information and the need to distinguish between drug and treatment effects.

Abrams stated that while these drugs have powerful brain-based actions, there is still a lack of evidence about their precise and safe action in treating PTSD.

It’s important to distinguish between the effects of the drugs and non-drug interventions, such as therapy. Both the drug and the placebo groups in the MDMA study showed positive effects. This indicates that intensive talk therapy is beneficial. This gives hope for non-drug treatments as well,” he said.

The FDA, on its part, defended their stance.

Dr. Marta Sokolowska is the deputy center director for substance abuse and behavioral health at the FDA’s Center for Drug Evaluation and Research.

MAPS’ Follow-up Call

MAPS organized a press briefing that focused on the issue. The FDA avoided the topic, but the MAPS press conference did.

According to Betty Aldworth of MAPS, the FDA call “illustrated growing public interest in psycho-assisted therapy, with nearly all speakers discussing their potential at a meeting which wasn’t about psychedelics.”

Aldworth noted that “Eighty members from Congress, the Veterans Affairs Administration (VA), trauma experts, patient advocate, and 14 out of 23 stakeholders who provided oral testimony agreed that the existing evidence for psychedelic assisted therapies merits widespread and growing support.”

Aldworth was blunt about the impact of FDA’s delays. “It’s been heartbreaking not only for MAPS but also for the thousands of people suffering from PTSD, who have reached out, desperate for an effective treatment.”

She claimed that the delay is driving people to the underground psychedelics markets in search of medicine.

She said that many people use psychedelics unregulated because they view them as their final chance to heal.

According to Dr. Bessel Van der Kolk, a trauma researcher who pioneered the field, only two FDA-approved drugs are available for PTSD, and they may not be effective for all patients.

He said that Prozac is not the cause of this.

One researcher who participated in the MAPS call emphasized the need for more inclusive criteria.

“The DSM-5 diagnosis criteria are highly suspect, particularly when it comes racial traumatic stress,” Dr. Darron said. “We need to use more holistic tools for evaluating healing and transformation in communities of color, especially.”

MAPS has outlined its next step, which includes continuing Phase 3 clinical trial as well as educating healthcare providers. MAPS will continue to work with regulatory bodies and states such as Colorado and Oregon, which are implementing psychedelic treatments that are regulated.

Aldworth said, “We will be putting our energy into the types of efforts that will provide access, regardless what the FDA requirements are because the reality is that many people can access these treatments today.”