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.

The University of Iowa Role in the Science Behind Psilocybin for Psychiatric Treatment

On April 9, 2024, the University of Iowa educational podcast, Rounding@Iowa presented a discussion about the study of the use of psilocybin in the treatment of psychiatric and addiction disorders. You can access the podcast below. The title is “Psilocybin Benefits and Risks.” The format involves an interview by Dr. Gerard Clancy, MD, Senior Associate Dean for External Affairs, Professor of Psychiatry and Emergency Medicine with distinguished University of Iowa faculty and clinician researchers.

In this presentation, the guest interviewees are Dr. Michael Flaum, MD, Professor Emeritus in Psychiatry, University of Iowa Carver College of Medicine, and Dr. Peggy Nopoulos, MD, Chair and Department Executive Officer for the University of Iowa Department of Psychiatry, Professor of Neurology, Pediatrics, and Psychiatry, University of Iowa Carver College of Medicine.

All three of these highly respected and accomplished faculty taught me when I was a trainee in the psychiatry department and afterward were esteemed colleagues.

86: Cancer Rates in Iowa Rounding@IOWA

Iowa's cancer rates are among the highest in the country, and they are rising. In this episode of Rounding@Iowa, Dr. Gerry Clancy and guest experts Dr. Mary Charlton and Dr. Mark Burkard discuss the data, risk factors, and prevention strategies clinicians can use to make a difference. CME Credit Available:  https://uiowa.cloud-cme.com/course/courseoverview?P=0&EID=81274  Host: Gerard Clancy, MD Senior Associate Dean for External Affairs Professor of Psychiatry and Emergency Medicine University of Iowa Carver College of Medicine Guests: Mark E. Burkard, MD, PhD Professor of Internal Medicine-Hematology, Oncology, and Blood and Marrow Transplantation University of Iowa Carver College of Medicine Director, University of Iowa Health Care Holden Comprehensive Cancer Center Mary Charlton, PhD Professor of Epidemiology Director, Iowa Cancer Registry Iowa College of Public Health Financial Disclosures:  Dr. Clancy, Dr. Burkard, Dr. Charlton, and Rounding@IOWA planning committee members have disclosed no relevant financial relationships. Nurse: The University of Iowa Roy J. and Lucille A. Carver College of Medicine designates this activity for a maximum of 0.75 ANCC contact hour. Pharmacist and Pharmacy Tech: The University of Iowa Roy J. and Lucille A. Carver College of Medicine designates this knowledge-based activity for a maximum of 0.75 ACPE contact hours. Credit will be uploaded to the NABP CPE Monitor within 60 days after the activity completion. Pharmacists must provide their NABP ID and DOB (MMDD) to receive credit. UAN: JA0000310-0000-25-090-H99 Physician: The University of Iowa Roy J. and Lucille A. Carver College of Medicine designates this enduring material for a maximum of 0.75 AMA PRA Category 1 CreditTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Other Health Care Providers: A certificate of completion will be available after successful completion of the course. (It is the responsibility of licensees to determine if this continuing education activity meets the requirements of their professional licensure board.) References/Resources:  Iowa Cancer Plan  
  1. 86: Cancer Rates in Iowa
  2. 85: Solutions for Rural Health Workforce Shortages
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  4. 83: Hidradenitis Suppurativa
  5. 82: End-of-Life Doulas

The link icon adjacent to the title of the podcast takes you to the podcast website. The link to the article in Iowa Magazine about the psilocybin research at University of Iowa Health Care tells you more about Dr. Peggy Nopoulos and her role as principal investigator in the study.

There is also a link to the National Library of Medicine Clinical Trials web site where you can find out more details about the study design. You’ll notice a banner message which says: “The U.S. government does not review or approve the safety and science of all studies listed on the website” along with another link to a disclaimer with more details.

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.