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FDA advisory panel ruling on MDMA therapy offers more evidence for why the Drake Center approach is safe and effective

FDA advisor panel ruling on MDMA therapy offers more evidence for why the Drake Center approach is safe and effective. 

A federal advisory committee to the Food and Drug Administration voted 10-1 against the overall benefits of MDMA (Methyl​enedioxy​methamphetamine, commonly known as ecstasy) when used to treat post-traumatic stress disorder. They cited flawed study data, questionable research conduct, and significant drug risks, including the potential for heart problems, injury, and abuse.

“It seems like there are so many problems with the data — each one alone might be OK, but when you pile them on top of each other … there’s just a lot of questions I would have about how effective the treatment is,” said Dr. Melissa Decker Barone, a psychologist with the Department of Veterans Affairs, in an interview with the Associated Press. 

13M adults in the U.S. suffer from PTSD during a given year.  The non-profit research group Multidisciplinary Association for Psychedelic Studies (MAPS) was hoping to prove the benefit of using MDMA to treat PTSD.  The panel ruling is a setback.

“I think this makes the availability of ketamine more important as it is the only FDA-approved psychedelic at this time that has proven safety and therapeutic profiles,” says Dr. Cassius Drake of the Drake Center for Healing. “Ketamine is an FDA-approved medication, and we can continue to use it in the way we have been.” 

WWJ Radio in Detroit contacted Dr. Drake for his opinion on the MDMA ruling. Play the video to hear his response:  

More from Dr Drake:

The path for MDMA to be approved has gotten much longer. MAPS may have to do another study addressing the panel's concerns. While there is a slight chance the FDA would still choose to approve MDMA, they usually go along with the recommendation of this panel with a vote of 10-1 against approval seems unlikely. 

Moving forward, this decision by the panel reinforces the idea that psychedelic treatment can be effective, as the data showed, but it must be done safely and ethically. The science has to be sound, and the improvements must be real and long-lasting.  The issues raised about the physical side effects can be managed by appropriate screening, and having professionally trained and experienced therapists who practice according to sound ethical guidelines is essential. I believe the Drake Center exemplifies this in our approach involving guidance, experience, and sound medical practice around safety and ethics. 

The Drake Center and its proven practice of Guided Ketamine Therapy vs. MDMA

Ketamine has shown remarkable efficacy in treating treatment-resistant depression (TRD). Many patients who do not respond to conventional antidepressants find significant relief with ketamine therapy. MDMA’s primary research focus has been on PTSD, and while it shows promise, it has not demonstrated the same level of efficacy in treating TRD.

Ketamine is believed to promote neuroplasticity, helping to restructure neural pathways and potentially providing long-lasting benefits. This neuroplastic effect can help patients develop healthier thought patterns and behaviors. While MDMA also has potential long-term benefits, the neuroplastic effects of ketamine are more directly linked to its mechanism of action.

Ketamine is used not only for depression but also for anxiety disorders, PTSD, and chronic pain management. Its versatility makes it a valuable tool for treating various mental health conditions. MDMA’s primary research and therapeutic applications have been focused on PTSD, with less evidence supporting its use for other conditions.

At the Drake Center, we believe that guided ketamine therapy simply opens the door to healing.  It helps our patients become “unstuck” and move forward.  We use meditative art therapy and virtual reality therapy to further the well-being journey.

More About Our Process

We employ the "Way of the Butterfly" a guided paradigm for transforming consciousness. As the consciousness of a caterpillar through a journey of readiness, surrender and growth becomes a butterfly, our process supports and guides individuals through this journey of change.  The process begins with the intake and preparation visits where we begin to identify those areas where ketamine assisted therapy can be most effective, effectively setting a “north star” for the process. 

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