FDA Has Yet to Decide on What to Do About the Clozapine REMS Program

I checked on what the FDA is doing about changing or closing down the Clozapine REMS program. It doesn’t look like they’ve taken any action yet. Recall there was a Clozapine REMS Advisory Committee meeting about this on November 19, 2024 that I posted about recently. The upshot was that the committee voted overwhelmingly (14 yes to 1 No) to get rid of the Clozapine REMS program.

What I didn’t realize until today was that a former colleague of mine was a member of the committee. Dr. Jess Fiedorowicz, MD, PhD was on staff at The University of Iowa Health Care in the past and is now head of the Dept of Mental Health at The Ottawa Hospital in Ottawa, Ontario in Canada. I’ve included the YouTube video below of the meeting and you can find Dr. Fiedorowicz’s remarks via Zoom video at around the 8:05 or so mark into the meeting. You can view his vote to shut down the REMS program at around 8:33.

I also found out about a group called The Angry Moms (those who care for family members on clozapine) who are focused on stopping the Clozapine REMS program and one of their web pages makes it pretty clear they’re not happy that the FDA has not made a decision about REMS yet.

They mention Dr. Gil Honigfeld, PhD who I’d never heard of until now. You can tell from his T-shirt how he feels about clozapine. He has been called the “Godfather of Clozapine” and his opinion about the REMS program along with a short history of clozapine can be found at this link.

I don’t know what the FDA will do about the Advisory Committee’s recommendation, but I hope they do it soon.

Is Edinburgh Manor in Iowa Haunted?

I have no idea whether an old former county home in Jones County is one of the most haunted places in the Midwest or Iowa or the USA. And I wouldn’t be saying that if Sena and I had not watched a TV show called “Mysteries of the Abandoned” (broadcast on the Science Channel) which aired a 20-minute segment about Edinburgh Manor the other night.

Supposedly, Edinburgh Manor started off as a county poor farm back in the 1800s, which didn’t do well and then quickly declined into an asylum for the mentally ill. When a couple bought the old place after it closed sometime between 2010 and 2012, they started to report having paranormal experiences and it was then off to the races for the place to become a haunted attraction, for which you can buy tickets for day passes and overnight stays.

There’s a 10-minute video by a newspaper reporter who interviews the wife and which shows many video shots of the house. I can’t see any evidence that it’s on the National Register of Historic Places.

What this made me think of was the Johnson County Historic Poor Farm here in Iowa City, which is on the National Register of Historic Places. We’ve never visited the site, but you don’t pay admission and the tone and content of the information I found on the website is nothing like what’s all over the web about Edinburgh Manor. There are no ghosts tickling anybody at the Johnson County Historic Poor Farm.

There’s a lot of education out there about the history of county poor farms in general. In Johnson County, Chatham Oaks is a facility that houses patients with chronic mental illness and it used to be affiliated with the county home. It’s now privatized. The University of Iowa department of psychiatry used to round on the patients and that used to be part of the residents training program (including mine).

I found an hour-long video on the Iowa Culture YouTube site about the history of Iowa’s county poor farms. It was very enlightening. The presenter mentioned a few poor farms including the Johnson County site—but didn’t say anything about Edinburgh Manor.

Music Therapy in End of Life Care Podcast: Rounding@Iowa

I just wanted to make a quick shout-out to Dr. Gerry Clancy, MD and Music Therapist Katey Kooi about the great Rounding@Iowa podcast today. The discussion ran the gamut from how to employ music to help patients who suffer from acute pain, agitation due to delirium and dementia, all the way up to even a possible role for Artificial Intelligence in the hospital and hospice.

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
  3. 84: When to Suspect Atypical Recreational Substances
  4. 83: Hidradenitis Suppurativa
  5. 82: End-of-Life Doulas

Artificial Intelligence: The University of Iowa Chat From Old Cap

This is just a quick follow-up which will allow me to clarify a few things about Artificial Intelligence (AI) in medicine at the University of Iowa, compared with my take on it based on my impressions of the Rounding@Iowa presentation recently. Also, prior to my writing this post, Sena and I had a spirited conversation about how much we are annoyed by our inability to, in her words, “dislodge AI” from our internet searches.

First of all, I should say that my understanding of the word “ambient” as used by Dr. Misurac was flawed, probably because I assumed it meant a specific company name. I found out that it’s often used as a term to describe how AI listens in the background to a clinic interview between clinician and patient. This is to enable the clinician to sit with the patient so they can interact with each other more naturally in real time, face to face.

Further, in this article about AI at the University of Iowa, Dr. Misurac identified the companies involved by name as Evidently and Nabla.

The other thing I want to do in this post is to highlight the YouTube presentation “AI Impact on Healthcare | The University of Iowa Chat From the Old Cap.” I think this is a fascinating discussion led by leaders in patient care, research, and teaching as they relate to the influence of AI.

This also allows me to say how much I appreciated learning from Dr. Lauris Kaldjian during my time working as a psychiatric consultant in the general hospital at University of Iowa Health Care. I respect his judgment very much and I hope you’ll see why. You can read more about his thoughts in this edition of Iowa Magazine.

“There must be constant navigation and negotiation to determine if this is for the good of patients. And the good of patients will continue to depend on clinicians who can demonstrate virtues like compassion, honesty, courage, and practical wisdom, which are characteristics of persons, not computers.” ——Lauris Kaldjian, director of the Carver College of Medicine’s Program in Bioethics and Humanities

Rounding At Iowa Podcast: “The Promises of Artificial Intelligence in Medicine”

I listened to the recent Rounding@Iowa podcast “The Promises of Artificial Intelligence in Medicine.” You can listen to it below. Those who read my blog already know I’m cautious and probably prejudiced against it, especially if you’ve read any of my posts about AI.

I was a little surprised at how enthusiastic Dr. Gerry Clancy sounded about AI. I expected his guest, Dr. Jason Misurac, to sound that way. I waited for Gerry to mention the hallucinations that AI can sometimes produce. Neither he nor Dr. Misurac said anything about them.

Dr. Misurac mentioned what I think is the Ambient AI tools that clinicians can use to make clinic note writing and chart reviews easier. I think he was referring to the company called Ambience.

I remember using the Dragon Naturally Speaking (which was not using AI technology at the time; see my post “The Dragon Breathes Fire Again”) speech to text disaster I tried to use years ago to write clinical notes when I was practicing consultation-liaison psychiatry. It was a disaster and I realize I’m prejudiced against any technology that would make the kind of mistakes that technology was prone to.

But more importantly, I’m concerned about the kind of mistakes AI made when I experimented with Google Bard on my blog (see posts entitled “How’s It Hanging Bard?” and “Update to Chat with Bard” in April of 2023.

That reminds me that I’ve seen the icon for AI assistant lurking around my blog recently. I’ve tried to ignore it but I can’t unsee it. I was planning to let the AI assistant have a stab at editing this post so you and I can see what happens. However, I just read the AI Guidelines (which everyone should do), and it contains one warning which concerned me:

We don’t claim any ownership over the content you generate with our AI features. Please note that you might not have complete ownership over the generated content either! For example, the content generated by AI may be similar to others’ content, including content that may be protected by trademark or copyright; and copyright ownership of generative AI outputs may vary around the world.”

That is yet another reason why I’m cautious about using AI.

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
  3. 84: When to Suspect Atypical Recreational Substances
  4. 83: Hidradenitis Suppurativa
  5. 82: End-of-Life Doulas

University of Iowa Psychiatrists Publish Huntington Disease Study Results

I ran across a fascinating story about a study on Huntington’s disease published by members of the University of Iowa Health Care. The study examined how the Huntington’s disease gene might enhance brain development and function early in life prior to the onset of the devastating disease. It was published in The Annals of Neurology:

I also found an abstract for a paper about Woody Guthrie, a famous American musician and activist who was very creative in his early life, but sadly succumbed to the ravages of Huntington’s disease when he was 55 years old. I couldn’t access the full article without paying for it but the abstract was intriguing because I wondered whether the author suspected something similar to the premise of the study:

Ringman JM. The Huntington disease of woody guthrie: another man done gone. Cogn Behav Neurol. 2007 Dec;20(4):238-43. doi: 10.1097/WNN.0b013e31815cfee4. PMID: 18091075. Abstract: Woody Guthrie was an American songwriter, musician, writer, and political activist who died with Huntington disease (HD) in 1967 at age 55. His relatively brief creative life was incredibly productive with countless songs and a tremendous volume of letters to his name. His personal life was similarly driven with Woody having had 3 wives and at least 9 children and an insatiable appetite for traveling the United States. In this essay, I explore Guthrie’s art in relation to the development of the overt behavioral changes and chorea that characterized his illness. Woody’s most productive time artistically was in the 5 years immediately preceding the onset of overt symptoms of HD. I hypothesize that subclinical HD may have been an important driving force behind Woody Guthrie’s creativity.

If anybody knows, please comment.

Woody Guthrie was certainly an important figure in the American history of activism as well as music.

Usually, I would share the music of some of the artists I mention on this blog. On the other hand, one of the co-authors of the University of Iowa paper mentioned above is Doug Langbehn, my former colleague, who’s an accomplished musician and statistician. So instead, I thought I’d share the talent of Doug and his band.

Reading My Old Book in a New Light

Sena bought me a wonderful new lamp to read by and it improves on the ceiling fan light I wrote about the other day (And Then a Light Bulb Went Off).”

The new lamp even has a nifty remote control with which you can choose the ambient feel. There are several selections, one of which is called “breastfeed mode,” a new one on me. There’s a light for that?

The lamp arrived at about the same time I got a notice from my publisher for my one and only book, “Psychosomatic Medicine: An Introduction to Consultation-Liaison Psychiatry,” that people are still buying—after 14 years! My co-editor was my former psychiatry department chair, Dr. Robert G. Robinson. As far as I know, Bob has dropped off the face of the earth. I hope he’s well.

Consultation-Liaison Psychiatry is probably about the same as I left it when I retired 4 years ago. I walked all over the hospital trying to help my colleagues in medicine provide the best possible care for their patients. I put in several miles and stair steps a day. I saw myself as a fireman of sorts, putting out fires all over the hospital. I got a gift of a toy fire engine from a psychiatrist blogger in New York a long time ago.

Now I walk several miles on the Clear Creek Trail, like I did yesterday and the day before that. I have shin splints today, which tells me something—probably overdid it.

So, I’m taking a break from walking and reading an old book in a new light.

U.S. News & World Report Ranks Iowa City Hospital in 9 Specialties

The University of Iowa Stead Family Childrens Hospital in Iowa City has ranked in 9 pediatric specialties, including pediatric behavioral health by U.S. News & World Report!

Thoughts on the Big Mo Pod Show “Funkin’ Down the Highway”

This is a post about the Big Mo Pod Show we heard last night on the KCCK FM radio dial 106.9. Incidentally, the KCCK fund drive was enormously successful this year, earning $100,000 in donations, according to Big Mo (aka John Heim) himself.

One item is the cover by Buddy Miles of the song “Tobacco Road.” This rendition was different from performances by other artists. Big Mo liked it and so did I. I did a little web search on it because I couldn’t catch all the lyrics. It was originally done by John D. Loudermilk in 1960. Miles’ version is essentially the same.

What interested me even more about “Tobacco Road” are the associations I have about it with specific literary works. I’ll admit I’ve never read nor seen the film adaptations of Erskine Caldwell’s books, “Tobacco Road” and “God’s Little Acre.” But one of my favorite short stories by James Thurber is “Bateman Comes Home,” which was published in a collection entitled “The Thurber Carnival,” in a hardcover edition in 1945. You’ve got to read it to get a sense of how comical the parody is of the regional dialect used in Caldwell’s novels. In fact, Thurber himself gives the game away about his intent in writing “Bateman Comes Home” by adding a wry comment as a subtitle:

Written after reading several recent novels about the deep south and confusing them a little—as the novelists themselves do—with “Tobacco Road” and “God’s Little Acre.”

He also adds another comment at the end of the short story: “If you keep on long enough it turns into a novel.”

The other thing I noticed about the podcast last night is that one of the songs which was not included in the list, “Joliet Bound,” was performed by an artist I haven’t heard of, the Reverend Shawn Amos, who is no relation to me, of course. But my background as a psychiatrist made me take special notice of details about his family, one of which is that his mother, Shirl-ee Ellis, a singer herself, had been diagnosed with schizoaffective disorder. Sadly, she eventually died by suicide. Shawn Amos is also the youngest son of the Famous Amos chocolate chip cookie founder, Wally Amos (again, no relation), although I’ve gotten a lot of friendly ribbing about that.

The song “Joliet Bound” is about a guy who expresses that he’s wrongly accused of killing a man over a woman and is on his way to Joliet prison in Joliet, Illinois. The Joliet Prison is a tourist destination nowadays and has other distinctions attached to it. It was featured in the 1980 film, the Blues Brothers. There were some famous inmates there, among them John Wayne Gacy, who was once evaluated and diagnosed with antisocial personality disorder by psychiatrists at The University of Iowa in 1968 as described in Dr. Donald Black’s book, “Bad Boys, Bad Men: Confronting Antisocial Personality Disorder (Sociopathy).”

Congratulations KCCK Radio!

Can Artificial Intelligence Learn from My Book?

Recently the publisher of a book co-edited by me and my former psychiatry chair Dr. Robert G. Robinson asked me to sign off on a proposal to involve Artificial Intelligence (AI) in using the work.

The book, “Psychosomatic Medicine: An Introduction to Consultation-Liaison Psychiatry,” is 14 years old now, but is still a practical tool for learners, at least in my opinion.

Interestingly, it looks like the publisher is also trying to contact Dr. Robinson about the proposal through me. I wonder if that means they’re having as much trouble finding him as I have.

I’ve made it clear that I have misgivings about AI, as I’ve indicated in at least one blog post about Google’s AI, which used to be called, Bard which I think has been renamed Gemini. I think AI is prone to spreading misinformation, which has been called “hallucinations” by some writers.

The publisher makes it clear that this proposal regarding AI involvement in our book is an “opt in” choice. I gather that means if I don’t opt in, they’ll continue to bug me about it until I do.

That’s unlikely to happen.