Navigating the Fallout: FDA's MDMA Verdict & Matthew Perry's Case
Synopsis: Explore recent developments in the psychedelic therapy world in this blog - focusing on the FDA's recent decisions regarding MDMA for PTSD and the implications of Matthew Perry's tragic death related to ketamine misuse. We also discuss an alternative PTSD treatment, stellate ganglion blocks, as well as highlight the importance of safe ketamine practice in light of these events.
Key takeaway: While recent setbacks in psychedelic approvals challenge the community, opportunities like stellate ganglion blocks provide hope. It's crucial for ketamine clinics to practice safely and educate the public on therapeutic versus misuse scenarios.
A Turbulent Summer in The Psychedelic World
A lot has been going on in the world of psychedelics this summer—and not all of it has been positive. We aim to share updates from the psychedelic and ketamine spaces, focusing on recent pivotal moments. In this post, we are covering two topics: 1) the FDA’s decision on MDMA therapy, and 2) the recent findings of the investigation into actor Matthew Perry’s ketamine-related death.
The FDA's Decision on MDMA for PTSD: It’s a No Go
The FDA recently opted to delay and not recommend MDMA for PTSD treatment according to phase three trials. MAPS, now known as Lycos Therapeutics, faced rejection just as they neared the final approval stage after over 30 years of dedicated research.
We kind of knew this was going to occur because the advisory panel to the FDA voted against recommending MDMA for PTSD treatment. They had concerns over the study's lack of blinding, insufficient lab work, and the critical role of psychotherapy in the trials.
The FDA has called for more research, highlighting the need for specific improvements before another application submission. This decision impacts many PTSD patients who might have benefited from this treatment.
Despite the setback, there's a silver lining as the FDA has acknowledged the potential of MDMA by encouraging further research. This decision comes after Rick Doblin and his team invested heavily in bringing this innovative treatment to trial.
An Alternative PTSD Treatment: Stellate Ganglion Blocks
Although MDMA therapy is not approved currently, there are other options available for patients - and it is critically important that we inform our patients and public on this. While there are better-known standard treatments such as cognitive behavioral therapy and medications such as some SSRIs, there is also a lesser-known treatment that we have begun to provide at our clinic—stellate ganglion blocks. It is important to note: at this time the FDA has not approved this procedure for the treatment of PTSD,
The stellate ganglion block (SGB) procedure is not a new one; it was first performed in the mid-1920s for pain. This procedure involves injection of a local anesthetic +/- steroid near the stellate ganglion located at the C6 or C7 vertebral level.
Ongoing research and patient experiences suggest significant relief from PTSD symptoms, with some finding ongoing benefits from a single treatment although some patients may require multiple treatments.
Proper ketamine use and administration are crucial to the safety of our patients, as seen in the case of Matthew Perry.
The Dangers of Improper Ketamine Use Illustrated by Matthew Perry's Death
Matthew Perry tragically passed away last year due to acute ketamine intoxication, as reported by the coroner, combined with buprenorphine and benzodiazepines amid severe comorbidities. His death has brought significant attention to the potential dangers associated with ketamine misuse.
The investigation into Perry's death revealed that he was receiving ketamine from unauthorized sources, in addition to treatment at a regulated clinic. His personal assistant, not medically trained, administered multiple intramuscular ketamine injections. This led to criminal charges against two physicians and other involved parties, underscoring the critical need for regulation and proper training in administering ketamine treatments.
The Role of Education on Public Perception of Ketamine
Public perception of ketamine is often influenced by its portrayal in the media and controversies that make it on the news. This high-profile case has unfortunately associated the word "ketamine" with criminal activities in the public's mind.
Therefore, as a ketamine specialist, you have to educate the public and colleagues about the difference between ketamine's therapeutic use and its misuse. As a clinic owner and an advocate for the safe use of ketamine, it's crucial to address the public's mixed perceptions and involve clear communication about the risks and benefits.
Explore strategies to uphold ethical practices and manage public relations effectively, especially in light of high-profile incidents at our Why You Should Care About Your Clinic's Ketamine Image: A Specialist's Guide blog post.
Ensuring Safety in Ketamine Therapy Practices
Ketamine can be very therapeutic, yet it can also be very dangerous in the wrong hands. At our clinic, we emphasize monitoring all patient vital signs and never prescribe ketamine especially if self-administered intramuscularly. Such measures prevent misuse and enhance the therapeutic potential of ketamine, ensuring it is used safely and effectively.
Although ketamine therapy can be very safe, it has an addictive potential, especially in certain patient populations. We must be cognizant of this fact as we screen and treat patients. Since this is a relatively novel space, we need to do it even more - crossing all the T’s and dotting all the I’s. We must practice with integrity as we care for our patients.
Listen to the episode on Apple Podcasts, Spotify, Overcast, or on your favorite podcast platform. Watch the discussion on YouTube here.
Related Questions:
What was the FDA's decision regarding MDMA for PTSD?
The FDA recently chose not to recommend MDMA for PTSD treatment and has called for additional research, highlighting concerns over study blinding and the critical role of psychotherapy.
What lessons can ketamine clinics learn from the investigation into Matthew Perry's death?
Ketamine clinics can learn the importance of regulation and proper training in administering ketamine treatments from Matthew Perry's case. We emphasize and teach the need for monitoring all patient vital signs, avoiding or minimizing the prescription of self-administered ketamine, and maintaining high standards of practice to ensure safety and integrity in ketamine therapy.
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Explore recent developments in the psychedelic therapy world in this blog - focusing on the FDA's recent decisions regarding MDMA for PTSD and the implications of Matthew Perry's tragic death related to ketamine misuse. We also discuss an alternative PTSD, stellate ganglion blocks, as well as highlight the importance of safe ketamine practice in light of these events.
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