Go Retire Psychiatrist

Heeeeeere’s Arnie—at the FDA Advisory Committee Meeting

I got a big kick out of Acting Chair of the FDA’s Vaccine and Related Biological Products Advisory Committee. Dr. Arnold Monto at the FDA meeting last month for the Pfizer COVID-19 vaccine booster. Everybody else did too, I bet. They all called him Arnie. I’m looking forward to seeing Arnie in action again this week for the meeting on the other boosters, Moderna and J&J. They’ll also discuss mixing and matching vaccine boosters—if Arnie lets them.

Arnie is pretty good at keeping speakers on a timeline. Everybody has a short leash. “That’s all you can ask.” “Keep it short, or I’ll cut you off.” “Hurry up, people want to get out in their gardens.” (He actually said something like that toward the end of the last meeting). The end of the meeting was abrupt. Arnie evidently expected the Advisory Committee on Immunization Practices (ACIP) to tidy up the regulatory decision with which the FDA committee seemed to struggle regarding the Pfizer booster.

I’m not the only one who notices Arnie’s preference for terseness. I found the article “Hearing Without Listening” by David S. Hilzenrath, who posted it on the web, December 16, 2020 on POGO.

I think Hilzenrath was a little hard on Arnie. People do tend to talk too much at meetings and that can interfere with getting things done.

I wonder what Arnie thinks about the Moderna and J&J boosters and the heterologous vaccination dosing strategies (“mixing and matching”)? My impression of what I read in the news is that different experts might be purposely jazzing up the topic, sending readers in different directions decorated with teaser headlines and leading statements. One might say something like, sure, the booster does what it’s supposed to do, which is boost—but does it boost enough? Another might say the boosters are barely needed. Many of them tend to be identified as “former” directors of something or other.

I’m not sure I’ll pay much attention to the hour long open public hearing, 3-minute-long diatribes per speaker on the miraculous properties of lemon-freshened Ivermectin gummies, including breathless accounts of also witnessing armies of Bigfoot hacking hairballs at armies of Gray Aliens doing impressions of Elvis (“thank ya-thank ya very much”) all on the head of a pin. If YouTube is kicking out purveyors of COVID-19 vaccine misinformation, why can’t the FDA and CDC advisory committees do the same?

I wonder if Arnie will rush the upcoming meeting because has a butternut squash garden he wants to get back to as soon as possible?

OK, we’re done here. You need to pick your pumpkins.

Thoughts on Transplant Psychiatry

I see in the news that organ transplant centers have removed a few patients from wait lists because they refuse COVID-19 vaccines. It may seem odd, but this reminds me of an even more difficult situation in organ transplantation. What do you do about those who just refuse organ transplant altogether?

I used to be a psychiatric consultant and that meant providing psychiatric consultations to the organ transplant service as well.

As anyone can imagine, refusing a transplant is uncommon. But it happens.

There are strong contraindications to transplant, among them severe psychiatric illness, medical noncompliance, absent social support, and active substance use.

There are not enough organs to go around. Many transplant candidates die every year while on the waiting list. Graft survival rates are usually shorter than survival rates, meaning some patients will need more than one transplant.

This means that selection criteria for candidates must be fair and realistic. More than 95% of transplant programs require psychosocial evaluations. There are usually not enough transplant psychiatrists to do this so a team approach is used in which social workers, nurse practitioners, psychologists, substance use disorders experts, and psychiatric consultants collaborate.

While it can be unsettling to remove a patient from the wait list, few people outside of the transplant center realize it can be even more upsetting to hear a patient say “no” to transplant. In all cases, the patient’s life probably has been saved many times. Often, all members of the team have invested a great deal of emotional energy to keeping the patient in the game.

There is also another incentive for transplant centers which must, in all fairness, be acknowledged. The government requires centers to do a certain number of transplant surgeries a year to retain their transplant Medicare certification. The procedure itself costs hundreds of thousands of dollars.

One typical letter from a transplant center can look like this:

“…specific outcome requirements must be met by transplant centers as outlined by the Centers for Medicare and Medicaid Services. Programs are required to notify their patients if these requirements are not met. Currently, Hospital X meets all requirements for transplant centers.”

There is a report by the Scientific Registry of Transplant Recipients (SRTR) which updates transplant statistics for all transplant programs. Anyone can look at the numbers.

This can become a point of pride and possibly some competition between centers. The older reference below is an example:

“Does Competition Among Transplant Centers Lead to Efficient Organ Allocation?” Scanlon D, Ubel PA, Loh E; Academy for Health Services Research and Health Policy. Meeting. Abstr Acad Health Serv Res Health Policy Meet. 2001; 18: 17. Short answer is-probably not, rather leads to inappropriate listing.

This means that an ethics consultation would be a good idea in many complicated organ transplant cases. The University of Washington has a “4 Boxes” tool that I used as a guide for years. The contextual features box merits close examination.

Anyhow, the patient who outright refuses transplant presents the transplant team with a singular question. Does this patient want to die? Usually that triggers a call to the psychiatric consultant. My role as an interdisciplinary collaborator was to focus on identifying psychosocial challenges to address in order to maximize postoperative chances of successful outcomes. That sentence was from the team’s perspective. However, my real goal was to listen to the patient and try to understand. In fact, I had a dual role. My main role, from the point of view of the transplant team, was to enhance the suitability of the patient for transplant—from a psychiatric standpoint.

It was never that easy, especially when the patient didn’t want a transplant. Suitability was out the window. Also, there are more or less discrete phases of transplant.

The Evaluation Phase in which the patient is usually very sick, faced with a terminal illness, and eager to be transplanted.

The Waiting for Donor Phase, often a very stressful time, frequently marked by demoralization as others get transplanted sooner.

The Surgery and Postop Course Phase, which could be marked by difficulty accepting the new organ, fantasies about the life and death of the donor, and fear that one will take on the traits or identity of the donor.

Prior to coming up on the wait list, some factors which may influence transplant refusal:

Depression or grief
Denial
Delirium and dementia
Fear of transplant surgery or negative past experiences with surgeries
Concerns about postop quality of life
Ambivalence about surgery and/or survival
Acceptance of inevitability of death
- Frierson, R. L., J. B. Tabler, et al. (1990). “Patients who refuse heart transplantation.” J Heart Transplant 9(4): 385-91.

Ambivalence is one factor that has been studied. It has been described as the tension between the wish for an extended life for which transplant holds out a promise as contrasted with the:

Need to confront the desperate seriousness of their situation
Need to fathom undergoing an operation which will remove the very organ physically and symbolically sustaining life
Need to accept postop quality of life that could be less than acceptable because of the amount of suffering it could inflict
- Difficulty facing seriousness of situation
- Fear of the surgery
- Quality of life concerns

The tasks for the patients:

Realize they have a terminal illness
Accept the idea that a transplant is necessary to preserve life
Endure the uncertainty about acceptance or rejection for transplantation
Assimilate an enormous amount of information in a short period of time
Emotionally reinvest in the possibility of an extension of their lives

Even the normal person feels, as it were, two souls in his breast.”
E. Bleuler

How would this be addressed in a busy transplant center intent on saving lives and retaining certification?

Ironically, by acknowledging that refusal of transplant is an acceptable choice. Ambivalence is not necessarily a sign of mental illness. It’s probably fine to avoid trying to talk the patient into going ahead with the transplant. You can see that the psychiatric consultant is supposed to be the advocate for the patient, not necessarily always for the transplant team.

Try to help the transplant team tolerate their own emotional turmoil as well as the patient’s. Try to create a space in which the transplant team can debrief and grieve those “who choose not to be saved.”

Frierson, R.L., et al., Patients who refuse heart transplantation. J Heart Transplant, 1990. 9(4): p. 385-91.
Kuhn, W.F., B. Myers, and M.H. Davis, Ambivalence in cardiac transplantation candidates. Int J Psychiatry Med, 1988. 18(4): p. 305-14.

Stay in the chair.

FDA Advisory Committee Meetings on COVID-19 Vaccine EUA Amendments for Moderna, J&J Boosters and Heterologous Boosters, Pfizer Vaccine for Children

The FDA Advisory Committee will hold a meeting October 14-15 to discuss amendments to the Emergency Use Authorization (EUA) for Moderna and J&J COVID-19 boosters as well as heterologous boosting (mix and match). New data is available, including NIH preliminary results on the mix and match study.

The FDA also announced a meeting to discuss Pfizer COVID-19 vaccine for children age 5-11, which is scheduled for October 26, 2021.

Links to the livestream meetings details are in the press announcement (link above).

Meeting materials are posted here.

Get This Book: Every Deep-Drawn Breath

I just got Wes Ely’s new book, Every Deep-Drawn Breath. You do need to buy this book to learn about delirium, Post-Intensive Care Syndrome (PICS) and what Dr. Ely and colleagues are doing to prevent it. PICS is a syndrome patients suffer after being hospitalized with severe medical illness in critical care units. It includes impairments in cognitive skills (impaired executive functioning), emotional functioning (depression, anxiety, post-traumatic stress disorder), and physical function (weakness, myopathy, and neuropathy).

Reading the prologue and first chapter reminded me of my early years in medical school and residency. It also reminded me of my frustrations when I was working as a psychiatric consultant trying to teach my colleagues about delirium, which a large percentage of patients suffer in the intensive care unit (ICU). I retired a little over a year ago.

Dr. Ely’s book also reminded me that I wrote an article about delirium 10 years ago, which was published in Psychiatric Times. I can still find it on line. The title is “Psychiatrists Can Help Prevent Delirium.” Prevention is the key because once delirium sets in, the challenge to offset the neurocognitive impairment becomes far greater.

A couple of years before I wrote it, I had tried working in private practice in Wisconsin. Aside from gaining weight from the good food there, I didn’t adjust well and quickly returned to Iowa City. I did make a consultation visit to a primary care clinic where I worked, which was a welcome surprised to the clinician who asked for help. You can take the psychiatric consultant out of the hospital, but you can’t take the hospital out of the psychiatric consultant.

I also met Dr. Ely around that time as well, because I kidded him about what he wrote in another book, Delirium in Critical Care (2011). There was a couple of paragraphs in a section called “Psychiatrists and delirium.” I’m going to risk somebody rapping my knuckles about copyright rules, but I’ll quote the sentence that usually made me chuckle: “Should we, or should we not, call the psychiatrist? Can we replace them with a screening tool and then use haloperidol freely?”

I think that was meant to be funny—and it was in an ironic way. Every psychiatric consultant knows that the main treatment for delirium is not haloperidol, but treating the underlying medical illnesses. Anyway, I poked a little fun at that book section in a blog post (which I no longer have, called “The Practical Psychosomaticist”) and shortly thereafter, he emailed me, asking me to write a few posts highlighting the serious and important research he and others were conducting about delirium. I learned a lot.

Eventually, I actually met Dr. Ely, at meeting of the American Delirium Society in Indianapolis. I respect and admire him. He’s a brilliant doctor and a caring man. And you should buy his book.

Rather Fight Than Switch?

I wonder how many baby boomers remember those TV cigarette commercials featuring an actor holding a smoke, sporting a black eye and saying “I’d rather fight than switch.” I guess they ran those ads from the 1960s to 1981.

I think of those commercials when I read the news. There are a couple of Iowa news items about a University of Northern Iowa (UNI) professor requiring his students to wear masks or suffer the consequences to their lab grades. He’s suffering the consequences because he’s going up against policies of the state Regents and UNI, which prohibit mask mandates. He’s doing it to protect others from COVID-19 infection. It sounds like he’d rather fight than switch.

The Governor of Iowa has signed into law a ban on applying mask mandates. However, Iowa City Mayor Bruce Teague has just extended “until further notice” a city-wide mask mandate that started August 18 and was set to expire today. Iowa Attorney General Tom Miller has been studying the situation for weeks and has apparently made no decision, despite the Governor’s office saying the mandate is “illegal” and “unenforceable.” I guess Mayor Teague would rather fight than switch.

There has been an executive order by President Biden to mandate COVID-19 vaccines for the many hospitals which have over a certain number of employees and are paid by Medicare and Medicaid. Headlines indicate there are many who would rather quit their jobs than get the jabs, which would not make patient care any easier. I guess they would rather fight than switch.

A man in Germany recently walked into a convenience store to buy beer and when the clerk asked him to put on a mask, the man left angry, came back wearing a mask and shot the clerk dead. I guess he’ll do the rest of his fighting in prison.

There a few songs about fighting and switching. I don’t remember Ruby Johnson’s version of “I’d Rather Fight Than Switch.” There was another version done by a group called The Tomboys, a group of female vocalists I’ve never heard of who were also performing in the 1960s. It looks like country star George Jones did a reversal of it with “I’d Rather Switch Than Fight.”

I wonder how things would be if people would start saying “I’d Rather Talk Than Fight.”

COVID Conspiracy Theories

A few days ago, I read the news story about COVID-19 antivaxx vigilantes interfering with the medical care of patients hospitalized with COVID-19. The writer interviewed Dr. Wes Ely, MD, MPH. He’s an intensive care unit (ICU) specialist at Vanderbilt University.

I first corresponded with Dr. Ely by email about 10 years ago when I wrote a blog called “The Practical Psychosomaticist.” I sort of poked fun of him in one of my posts about the chapter on psychiatrists and delirium in one of his books, Delirium in Critical Care, which he co-authored with another intensivist, Dr. Valerie Page, and published in 2011.

I can’t really tell the anecdote the way I usually told it to residents and medical students because of copyright rules but the antipsychotic drug haloperidol is mentioned. I made fun of the very short section “Psychiatrists and Delirium” in Chapter 9 (“Treatment of delirium in critical care”). It’s only a couple of paragraphs long and comically gives short shrift to the psychiatrist’s role in managing delirium. That’s ironic because I have always thought the general hospital psychiatric consultant’s role was very limited in that setting.

Maybe you should buy that book and, while you’re at it, buy the other one he recently published this month, Every Deep-Drawn Breath. My wife just ordered it on Amazon. It’s reasonably priced but in order to qualify for free shipping, she had to buy something else. It turned out to be Whift Toilet Scents Drops by LUXE Bidet, Lemon Peel (travel size, not that we’re traveling anywhere in this pandemic). Be sure to get the Lemon Peel.

In the email Dr. Ely sent to me and many others about the book, he said, “Every penny I receive through sales of this book is being donated into a fund created to help COVID and other ICU survivors and family members lead the fullest lives possible after critical illness. This isn’t purely a COVID book, but stories of COVID and Long COVID are woven throughout. I have also shared instances of social justice issues that pervade our medical system, issues that you and I encounter daily in caring for our community members who are most vulnerable.”

Anyway, the Anti-Vaxx vigilantes have played a big role in filling up the Vanderbilt ICU and many others by posting conspiracy theories about the COVID-19 vaccines on social media, which for some reason are hard to control. They persuade patients and their families that doctors are trying to kill them with the treatments that are safe and effective. Instead, they recommend ineffective and potentially harmful interventions such as Ivermectin, inhaling hydrogen peroxide, and gargling iodine.

There are different opinions about conspiracy theories and those who believe in them. Some psychiatrists say that conspiracy theories are not always delusional. One psychiatrist wrote a short piece in Current Psychiatry, Joseph Pierre, MD, “Conspiracy theory or delusion? 3 questions to tell them apart.” Current Psychiatry. 2021 September;20(9):44,60 | doi:10.12788/cp.0170:

What is the evidence for the belief? Can you find explanations for it or is it bizarre and idiosyncratic?

Is the belief self-referential? In other words, is it all about the believer?

Is there overlap? There can be elements of both.

The gist of this is that the more self-referential the conspiracy theory, the more like it is to be delusional.

Another article which expands on this idea is on Medscape: Ronald Pies and Joseph Pierre, “Believing in Conspiracy Theories is Not Delusional”—Medscape-Feb 04, 2021. According to them, delusions are fixed, false beliefs (something all psychiatrists learn early in residency) and usually self-referential. Conspiracy theories are frequently, but not necessarily, false, usually not self-referential, and based on evidence one can find in the world—often the internet. Conspiracy theories have blossomed during the COVID-19 pandemic. One of them is that it’s a government hoax. An important difference between the current pandemic and the flu pandemic of 1918 is the world wide web which makes it easier for many people to share the conspiracy theories.

Pies and Pierre describe a composite vignette of someone who has a conspiracy theory featuring many false beliefs about the COVID-19 vaccines ability to change one’s DNA, thinks that research results about the vaccines are faked, mistrusts experts, has no substance abuse or psychiatric history and no mental status exam abnormalities. He exhibits exposure to misinformation, biased information processing, and mistrusts authorities.

They would say he has no well-defined psychiatric illness and antipsychotic treatment (such as haloperidol) would not be helpful. However, similar to the approach with frankly delusional patients, they would argue against trying to talk the person out of his false beliefs. Instead, if the person can be engaged at all, the focus should be on trying to establish trust and respect, clarifying differences in the information sources available, and allowing time for the person to process the information. It would be more helpful to avoid confrontation and arguments, instead pointing out inconsistencies in the information the person has and contrasting it with facts. Countering misinformation with accurate information could be helpful.

There are two major routes to anti-vaccination beliefs of the severity under discussion here. One is the problem of conspiracy theories out there. The other is the florid delirium that can happen to patients admitted to ICUs with severe COVID-19 disease. The former may not be a classifiable mental illness per se, but the latter definitely is.

Haloperidol is not the main solution for either problem.

Jab Who?

I just read a news item saying that the Blank Park Zoo in Des Moines, Iowa is administering COVID-19 vaccine to the animals there. I wondered how that would go, especially with large animals. I figured the zoo staff would be using dart guns. Talk about vaccine hesitance.

Then I saw a YouTube showing animals at the Louisville Zoo in Kentucky getting their shots. Apparently, they can get sick from COVID-19 infection. There were a few disparaging comments from viewers. Would 70 zoos vaccinate their animals if it weren’t safe and effective?

The animals didn’t seem to mind it. In fact, they were probably more cooperative than some humans. Of course, they got treats. But we give gift cards, beer, lottery prizes, turkey-flavored candy corn—which don’t really work. About 25% of Iowans don’t plan to get the vaccine according to a Des Moines Register news story.

Will the animals get boosters?

Featured image credit: Jim & Sena Amos at Henry Vilas Zoo in Madison, WI in 2009.

Proof of Simulated Reality—Or Cool Camera Trick?

I watch the History Channel TV show “The Proof is Out There” hosted by Tony Harris. Early this year (I think January), an episode featured a snapshot showing a woman who’s mirror reflection didn’t match her facial expression. It was striking. The question was whether this proved we live in a simulated reality (think of the film “The Matrix”). At that time, I think Tony and his panel of analysts (including a digital imaging expert) called the photo unexplained but stopped short of declaring it proof we’re all living in a simulation.

A couple nights ago, on an episode of the new season, Tony had to admit he and his colleagues got it wrong—because the snapshot can be created using the smartphone camera panorama mode. Somebody submitted a couple of photographs duplicating the effect of the one submitted in January along with an explanation of how to make them.

Sena and I checked this out. When I googled the term “panorama mirror trick,” I got several hits with step-by-step instructions and several YouTube presentations. Depending on what search terms you use, I could find internet references going back several years.

We played with the camera. It took a little practice, but we got the hang of it quickly. These are rough instructions:

Mirror trick:

Open the camera app and swipe to panorama mode.

Subject stands adjacent to the mirror, at an angle partly facing it and partly turned toward the camera operator.

Camera operator taps the shutter button while panning from one direction toward the subject and moving past, keeping the arrow centered on the straight horizontal line.

When camera operator has panned just past subject and before reaching the mirror, stop moving the camera and have the subject change position. This should take only a moment or so. If the camera is still moving, you’ll get a lot of motion artifact.

After subject has assumed the new posture, start panning again toward the mirror and a bit beyond, then tap the shutter button to end the shot.

You should get an image with the subject in one posture and the subject’s mirror reflection in a completely different posture.

Doppelganger trick:

I call this the doppelganger trick because the maneuver creates an image with two different images of the same subject in two different spots, creating a twinning or doppelganger effect.

Set up is the same as for the mirror trick but have the subject stand in one spot to the left of the camera operator and strike a pose.

Camera operator starts panning to the right, then stops briefly.

Subject zips behind the camera operator on the left side and takes up a new position on the opposite side.

Camera operator restarts the pan right and completes the shot after moving past the subject.

It may take a few tries, but when you get it right, the result looks startling. It’s fun.

Now here’s a question for Tony Harris. Do Doppelgangers exist?

CDC Statement on COVID-19 Vaccine Boosters

The CDC published a media statement this morning that outlines the amended Advisory Committee on Immunization Practices (ACIP) recommendations for COVID-19 vaccine boosters. Late last night, CDC Director Rochelle Walensky restored the recommendation that ACIP voted down yesterday: “People aged 18-64 years who are at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series, based on their individual benefits and risks.” This is consistent with the FDA regulatory recommendations made on Wednesday.

Now, to my understanding, at least in Iowa, according to University of Iowa Hospitals & Clinics (UIHC) and others, it’s up to the Iowa Department of Public Health (IDPH) to green-light the booster rollouts locally.

ACIP Meeting on COVID-19 Vaccine Boosters: Day Two

It must have been after 8:00 PM last night that the FDA posted the COVID-19 Booster EUA authorization. The ACIP took that ball and ran with it all day long. Today was the second day of the ACIP meeting and the committee covered a lot of ground and ran over the schedule by more than an hour by the time voting on recommendations ended.

In a nutshell:

The committee voted unanimously to give boosters for people 65 and over as well as nursing home residents. Most of them voted to give boosters to those 50-64 with medical conditions that raise the risk for severe COVID-19 infection. A smaller majority voted to give boosters to those 18-49 with based on individual benefit and risk given underlying medical conditions. The committee voted down a proposal to give boosters to those 18-64 who would be at elevated risk of infection because of occupational or other setting, including health care workers, prison guards, and people who live or work in homeless shelters.

Nobody was happy about not giving an option to “mix and match” vaccines. If you got Pfizer in the initial series, you got Pfizer. But if you got Moderna or J&J—you couldn’t get Pfizer. More data is coming about heterologous vaccine dosing, but it’s not immediately available. On the other hand, the 6-month mark for getting the booster is anything but a hard line. You could wait months longer and still retain adequate vaccine effectiveness.

I thought it was interesting that, according to a survey in unpublished data, about a third of unvaccinated respondents said that offering a booster would make them even less willing to get vaccinated at all. See slides 52 and 53 in the presentation “Evidence to Recommendation Framework: Pfizer -BioNTech COVID-19 Booster Dose” by Dr. Sara Oliver. Despite that, several members of the committee stressed the critical importance of continuing to attempt vaccinating them.

There’s going to be a lot of flux in the next several weeks as more data is obtained. These recommendations are subject to updates and there will likely be several more meetings ahead, according to attendees.

I know that in Iowa, a lot of people are counting on the Iowa Department of Public Health (IDPH) to give the word on when to roll out the boosters. The University of Iowa Hospitals & Clinics and Story County officials have said that. I have not seen boosters even mentioned on the IDPH website, though. I inquired about what their plans are for the booster rollout this morning on their website contact form. I expect it may be a while before I get a reply, if I get one at all. They’re incredibly busy.

I heard one expert say that in his community, they were offering the vaccine to people in a way that emphasized the individual’s benefit only. I think that’s certainly one way to “sell” it. Altruism has a place here, though. I get regular email messages from Hektoen International, hekint.org.

They almost always contain some essay or quote that’s thought-provoking and inspiring. Here’s one I got this morning that included a public domain photograph of Bertrand Russell as well as his thoughts on the receding ego:

Bertrand Russell on life from Hektoen International hekint.org

Make your interests gradually wider and more impersonal, until bit by bit the walls of the ego recede, and your life becomes increasingly merged in the universal life. An individual human existence should be like a river — small at first, narrowly contained within its banks, and rushing passionately past rocks and over waterfalls. Gradually the river grows wider, the banks recede, the waters flow more quietly, and in the end, without any visible break, they become merged in the sea, and painlessly lose their individual being.
“How to Grow Old,” from Portraits from Memory and Other Essays by Bertrand Russell