Tag: psychedelics

Thoughts About Psychedelic Assisted Psychotherapy

I read the Psychiatric Times article “FDA Issues CRL to Lykos for MDMA-Assisted Therapy.” The short story is that the FDA essentially told the drug company Lykos that their study of the efficacy of MDMA-assisted treatment of PTSD needs more work.

I tried to wade through the on-line documents of the FDA’s meeting on June 4, 2024. There are hundreds of pages and I didn’t go through every page of the transcript. The minutes were succinct and much easier to digest.

I’m going to simply admit that I’m biased against using psychedelics in psychiatry for personal and professional reasons. I’m not a research scientist. I’m a retired consultation-liaison psychiatrist. I saw many patients with a variety of psychiatric diagnoses including PTSD and substance use disorders. I’m not opposed to clinical research in this area, but I’m aware of the difficulty of conducting it.

In that regard, I want to also admit that I’m very susceptible to being influenced by a former colleague’s remarks about the quality of the research in question in the Lykos study. Dr. Jess G. Fiedorowicz, MD, PhD formerly was formerly on staff at University of Iowa Health Care. He’s now the Chief of Mental Health at The Ottawa Hospital where he’s also Professor and Senior Research Chair in Adult Psychiatry, Department of Psychiatry, University of Ottawa, Ontario. His remarks in the transcript are typical for his erudition and expertise as a clinician scientist.

It’s difficult to wade through the pages of the FDA transcript and I couldn’t digest all of it, by any means. But if you’re interested in reading both sides of this issue, it’s a good place to get the best idea of the committee members’ thinking about it. The minutes are much easier to read and provide a succinct summary.

I realize the Psychiatric Times article editor doesn’t agree with the FDA recommendations for further study of psychedelic-assisted psychotherapy for PTSD. It may or may not influence the University of Iowa’s study of psilocybin. In my opinion, the FDA did the right thing.

New Compound MM-120 Related to LSD Gets FDA Nod

I saw the story in Psychiatric Times about the compound MM-120, which the FDA recently granted breakthrough designation. MM-120 is related to LSD. Breakthrough designation is defined by the FDA as, “…a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).”

The compound is made by the company MindMed. This is not to be confused with mind meld, a Star Trek thing related to Vulcans like Spock who can do this telepathic touch thing. The MindMed organization made MM-120 to help treat people who suffer from Generalized Anxiety Disorder. Their study shows the drug could be used as a standalone treatment for the disorder.

According to one story about it published in the December issue of Drug Discovery and Development, it’s not likely MM-120 will be stocked in pharmacies next to the antihistamines and decongestants. The authors believe it would be more likely included in a Risk Evaluation and Mitigation Strategies (REMS) program.

This brings back nightmares about the Clozapine REMS program, which many psychiatrists found almost impossible to enroll in several years ago because of glitches in the web-based application. In fact, the FDA was still not happy with it a couple of years ago, to the extent they had to “temporarily exercise enforcement discretion” over aspects of the program.

Anway, the article goes on to say that the drug has a pretty good safety profile, although concede that the study found the higher dose of MM-120 led to “…perhaps some more challenging experiences….” There were no incidents of suicidal or self-injurious behavior.

I wonder what the “challenging experiences” were, exactly. After all, MM-120 is basically LSD, which was invented in 1938 by the Swiss chemist, Albert Hofmann. He was doing research into crop fungus. He thought it could be used to treat mental illness, even after he accidentally ingested some of it and hallucinated a future in which a guy named Timothy Leary would advise everyone to “turn on, tune in, drop out.”

That whole fungus research issue reminds me of the still unsettled question of how a whole town in France got higher than a kite (leading to some deaths) back in 1951. Ergot poisoning was the initial theory, although later somebody believed it might have been perpetrated as a secret LSD experiment by the CIA. I think the mystery is still unsolved.

However, there is also the history of MK-Ultra, which apparently actually was a classified CIA project running during the Cold War which involved giving LSD to certain unlucky subjects, some of whom didn’t know they were getting it—with disastrous results in some cases.

Just to let you know, I don’t suspect there is some conspiracy between extraterrestrials and the pentagon to get the world population so confused on LSD that we start believing all those crop circles are being created by two guys using a board and a rope. Forget what Agent Mulder says.

Trips and Trip-Killers

I just read this JAMA Network article on trip-killers. It’s about using drugs to stop bad trips caused by hallucinogens.

One mentioned was ketamine. When I was working as a consultation psychiatrist, I was called occasionally to evaluate patients in recovery rooms who were delirious from the ketamine that was sometimes used by anesthesiologists.

I found a paper with a list of ketamine’s limitations, which I think is helpful.

Trips and trip-killers can cause problems.

Maybe We Need a Dose of Humor

Sena and I were listening to the Mike Waters morning radio show (KOKZ 105.7) this morning and his invitation to listeners was to call in and quote their favorite dumb question. One of the callers recited something which was actually a George Carlin joke. Neither one of us thought we heard it right, but it’s the same framework as the joke I found on the web (only the numbers were changed):

“If you’ve got 24 odds and ends on the table and 23 of them fall off, what’ve you got? An odd or an end?”

This is an example of his wordplay humor.

Carlin’s humor was also marked by satire on American culture and politics, the latter of which has gotten pretty rough. You’ll also find references on the web to Carlin’s past history of substance use, which reportedly included psychedelics.

That reminds me of an opinion piece published in the September issue of Current Psychiatry, by the journal’s editor, Henry A. Nasrallah, MD (From neuroplasticity to psychoplasticity: Psilocybin may reverse personality disorders and political fanaticism. Current Psychiatry. 2022 September, 21(9): 4-6 | doi: 10.12788/cp.0283).

I was a little surprised at Dr. Nasrallah’s enthusiastic endorsement of psilocybin for treatment of personality disorders and political extremism. He acknowledges the lack of any studies on the issue. In the last paragraph of his essay is a sweeping endorsement:

In the current political zeitgeist, could psychedelics such as psilocybin reduce or even eliminate political extremism and visceral hatred on all sides? It would be remarkable research to carry out to heal a politically divided populace. The dogma of untreatable personality disorders or hopelessly entrenched political extremism is on the chopping block, and psychedelics offer hope to splinter those beliefs by concurrently remodeling brain tissue (neuroplasticity) and rectifying the mindset (psychoplasticity).

While I’m not so sure about how effective psilocybin would be for this, I’m all for trying something to reduce the “visceral hatred on all sides.”

Maybe humor could be part of the solution. It doesn’t have to be exactly like that of George Carlin. Both parody and satire have been used by many writers for this.

I like the distinction between parody and satire in one article I found on the web. One recent example of satire (or parody; the distinction is sometimes hard to make since the story was listed as “Iowa Parodies”) was in the news and it apparently fooled at least a few people. It was about the Iowa football coaching staff. The title was “Brian Ferentz Promoted to University President To Avoid Having to Fire Him (Satire): The move was deemed ‘a way easier conversation than having him fired’ by the athletic director. It was written by Creighton M, posted September 5, 2022.

I think the story was originally printed without the word “Satire” in the title. I can’t recall seeing the heading “Iowa Parodies” either. A later version of the story added the word “Satire.”

The story might have been about nepotism in the hiring of Brian Ferentz (he’s the son of head coach Kirk Ferentz) as offensive coach. On the other hand, under Iowa law, it was not illegal to hire Brian Ferentz, who in any case reports to athletic director Gary Barta, not Kirk Ferentz.

I suspect the joke had more to do with negative public attitudes about the performance of the Iowa football offense early in the season.

Is it funny? I guess it depends on your perspective. The Iowa football coaching staff probably didn’t chuckle over it. But it more or less fits the definition of satire. It uses humor to expose flaws in the way we behave. And it avoids direct and nasty confrontation, which usually triggers antagonism rather than collaboration. Will it change the Iowa football program? I doubt it. They’re actually doing pretty good so far.

But satire as a strategy to inform and maybe change the public opinion will endure. The Hitchhiker’s Guide to the Galaxy by Douglas Adams is one of my favorite books and it satirizes governments and the foolishness of people. I first learned about The Onion newspaper while we were in the process of relocating to Wisconsin (a short adventure). It satirizes the Associated Press news style.

One of the most uproarious examples of parody is a TV show which is no longer available on cable television but still offered on a streaming service (I think), Mountain Monsters. It’s a hilarious sendup of all the Bigfoot hunter shows.

The added benefit of parody and satire and other such forms of humor is that they are safer than psychedelics—unless your target was born without a funny bone.