Category: reflections

Music Beat

We listen to the Music Choice Channel almost every night on our TV. I know that must sound odd, listening to a music channel on television. What makes it more interesting are the biographical sketches. The Light Classical Channel bios occasionally have typos and word usage oddities as well as eyebrow raising facts:

Mozart’s full name was Johannes Chrysostomas Wolfgangus Theophilus “Bud” Mozart.

Frederic Chopin is not pronounced “Choppin” as in his well-known tune “I’m Choppin’ Onions in My Stew and Crying Over Losing You.”

Edvard Grieg was taught the violin by Ole Bull, which is a lot of bull since, at least in Iowa, bulls go “mooooo” and chase red bandanas.

Antonin Dvorak spent a summer in Spillville, Iowa in 1893 where he drank beer and toppled into the Turkey River.

Riveting stuff like that is usual for the Music Choice Light Classical Channel. On the other hand, some months ago, I heard a song called “The Penguin” by somebody named Raymond Scott. I looked him up today and he was a jazz composer and Music Choice must have misfiled him.

I can’t really make fun of his bio because it’s eccentric enough by itself. His music ended up in a lot of cartoons, but he didn’t do that on purpose. Scott sold the publishing rights to his work to Warner Bros. Music in 1943. The music director at that time was Carl Stalling, who used a lot of Scott’s compositions in cartoons, such as Looney Tunes and many others.

Raymond Scott wasn’t even his real name. He looked it up in a phone book and used it partly because it sounded cool. The other reason is more complicated. His real name was Harry Warnow and he was playing piano in a radio orchestra conducted by his brother, Mark in the 1930s. The band started playing Harry’s off-beat compositions and, in order to avoid the appearance of nepotism, Harry adopted the new name.

Scott also invented electronic musical instruments, and after a while, he spent most of his time doing that, working with engineers on many inventions.

I haven’t heard him on the Light Classical Channel for a long while now. Maybe Music Choice finally got him filed to the Jazz Channel.

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.

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.”

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.

Doppelganger

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?

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

Bertrand Russell by Fotograaf Onbekend / Anefo. 1957. Nationaal Archief. Public Domain. Via Wikimedia.

ACIP Meeting on COVID-19 Vaccine Boosters: Day One

This was the first day of the Advisory Council on Immunization Practices (ACIP) on COVID-19 vaccine boosters. I was struck by how organized it was. I was also struck by the statement by one presenter that they’re still waiting for a final decision from the FDA on the issue. I thought they made that last Friday. The decision has not yet been posted, though and I think it has to be published on the FDA website before it’s gospel.

In fact, ACIP is wondering if tomorrow’s meeting should be postponed if the FDA decision has not been made by then. Tomorrow is when ACIP plans to vote on what they decide about the who and how of the booster shots. Would they really leave it up in the air like that?

The only thing I see about boosters on the FDA website after the September 17th meeting is a podcast on September 20th that FDA Commissioner, Dr. Janet Woodcock did on a show called “In the Bubble with Andy Slavitt.” I thought it was a good general introduction to the booster issue. The interview also included questions about Pfizer’s latest study of their COVID-19 vaccine in children, ages 5-11 years of age. I thought there were too many commercials. There was supposed to be another broadcast about boosters on the show today, but I was too busy watching the ACIP meeting. I’m pretty sure I’m getting most of what I need from that, but I might check out the Andy Slavitt show “Toolkit: Answering Your Booster Questions.”

I know one thing; I heard the best lecture about the basic immunology of the boosters this morning. See the slides from the presentation “Adaptive immunity and SARS-CoV-2” by Dr. Dr. Natalie Thornburg, PhD. I still have cold sweats every time I think of the first basic immunology lecture we got in medical school. That was ages ago. The poor lecturer at some point during her talk happened to look up at us and she abruptly stopped talking. She looked dismayed by what must have been the totally lost look on our faces. She was demoralized and there was this—pause. She looked like all the air was sucked out of her. I thought for a moment she was too demoralized to go on.

I don’t remember how I got through the immunology exam. I do know I still have flunking nightmares of being a student at some level of college or medical school. In the dream, I’m usually trying to find a lecture hall, riffling through a key set of notes and books, all of which are incredibly jumbled up. I’m always hopelessly late and I have this sense of despair about ever graduating.

But today’s presentations were brilliant, fascinating, and helped clarify at least some issues in the complexity, not the least of which is deciding what the main goal of the boosters should be. Should it be preventing severe disease, hospitalization, and death, or preventing infection altogether?

I learned that not only are nursing home residents at high risk for getting COVID-19 but that it’s actually the level of community transmission that drives infection rates in residents (see presentation “Modeling the potential impact of booster doses in nursing home residents” by Dr. R. Slayton). Which brings up the issue of transmissibility of the virus, which is very high. Would the boosters cut the transmissibility? It’s unclear.

The boosters seem to be very safe and effective for pregnant people, yet only about 30% of them get vaccinated—cut that percentage in half for African American women. See the lectures with the word “pregnancy” in the title.

Dr. Sara Oliver’s “Work Group Summary” was enlightening and disturbing. The safety and immunogenicity date are reassuring but limited. But getting more data takes more time. What are the next steps for the ACIP? They are awaiting regulatory action from the FDA. I get a sense that we need a lot more beyond Dr. Janet Woodcock’s word on that. As she said in the “In the Bubble” interview with Andy Slavitt— “We need to get this right.” I think that means they need to take whatever time it takes to do that.

Will ACIP meet tomorrow? Will they vote? Don’t ask me; I still have flunking nightmares.

More COVID-19 Vaccine Booster Sausages This Week?

I saw a nice summary by Stat News of last Friday’s FDA Advisory Committee meeting on Pfizer’s COVID-19 vaccine booster. They indicate the Advisory Committee on Immunization Practices (ACIP) are meeting this coming Wednesday and Thursday to fine-tune the FDA recommendations, which was a messy affair. I have been checking the ACIP web site frequently but so far, I’ve not seen any agenda or slide sets for September 22 and 23. Is that a signal that watching their meeting will be even more like watching sausages being made?

Just as an aside on the quote attributed to Otto Von Bismarck I mentioned in my post on Friday—it’s probably apocryphal.

Laws are like sausages; better not to see them being made.”

Otto Von Bismarck or maybe John Godfrey Saxe

I glanced around the web and ran across several articles which cast doubt on whether the big sausage duel ever took place. It’s kind of a shame because it had the medical science angle. Supposedly the scientist Rudolf Virchow who was studying the parasite responsible for causing trichinosis had responded to Bismarck’s challenge to a duel by proposing they each eat one of two sausages as weapons. Bismarck and Virchow would choose a sausage to eat, one of which was loaded with trichinella or one that was not. They couldn’t tell by looking at the sausages which was which. I first learned about this duel on the Travel Channel show (episode entitled “Sausage Duel”), which I think set the context as nasty factories churning out Trichinella laden sausages because of horrifyingly unsanitary practices. The show cast Virchow and Bismarck as opponents over that issue specifically. Bismarck conceded and that led to the factories cleaning up their act. Scientists triumph over politicians!

That probably never happened, according to more than one writer. So maybe I should choose another quote. One by a lawyer statesman might be a partial fit:

If Columbus had an advisory committee, he would probably still be at the dock.

Arthur Joseph Goldberg

Another that I like just because I’m a Dave Barry fan:

“If you had to identify, in one word, the reason why the human race has not achieved, and will never achieve, its full potential, that word would be ‘meeting.’”—Dave Barry.

If you had to identify, in one word, the reason why the human race has not achieved, and will never achieve, its full potential, that word would be “meeting”.

Dave Barry

Some sources on the web say Barry’s quote was in one of his many books I used to own: Dave Barry Turns 50. It’s in a list: “25 Things I Have Learned in 50 Years.” I didn’t check with Barry’s web site to verify the quote. You can find some of them on line. Many of those items are on the order of booger jokes, of which I happen to be a fan. This quote also happens to be highlighted on the website called mycommittee, which ironically advertises committee management software which promises to make them more productive. The home page shows a sample software document entitled “Decisions regarding response to Covid-19.”

Hmm. Maybe the advisory committees could use this.

ADDENDUM: Whoa! ACIP just posted this Wednesday’s draft agenda. More materials will surely follow.

Watching Sausages, Laws, and FDA Advisory Committee Decisions Being Made

Sena and I watched the FDA Advisory Committee live streamed meeting yesterday on whether or not Pfizer’s COVID-19 vaccine booster should be given full licensure. You know, there’s a much-discussed question about who actually made the following quote:

“Laws are like sausages; better not to see them being made.”—often attributed to Otto Von Bismarck although it’s been attributed to others.

You can view the arguments about who said it at this link. The point is I think it should also apply to FDA meeting decisions. Our overall impression is that it was a messy process. We watched the entire daylong proceeding. The bottom line was that the committee revised the original question and reframed the approval from full licensure to Emergency Use Authorization (EUA):

The FDA approved the EUA for the booster based on the “totality” of the available evidence instead of just the originally specified Clinical Trial C4591001 (because of the small number of subjects including only a dozen in the older age group; the data from Israel was also fair game) and restricted the population to those age 65 and older (instead of the original 16 years and older). They further specified further that the booster should target those at increased risk for severe disease—which is to be understood to include health care professionals and others at risk for high occupational exposure.

One of the voting members disclosed candidly that his wife had already received a booster shot at a pharmacy well in advance of the meeting (technically off-label) and that he planned to do the same—after they unanimously approved the booster after the question was reframed. Sena and I both thought this was an extraordinary statement coming from an FDA advisory committee member.

The original question was voted down with only 2 of 18 members voting in favor. Dr. Stanley Perlman of The University of Iowa voted no on the original question and voted yes on the revised question. For many days now, the news has been reporting that a large number of people have been getting a booster shot despite the lack of FDA approval.

Dr. Arnold “Arnie” Conto M.D., the Acting Chair of the committee, after being asked to read the original question, slipped by indicating the age as “16 months” instead of “16 years.” He was instrumental in holding the committee members to staying on time for each phase of the meeting.

Dr. Conto: “Do the safety and effectiveness data from clinical trial C4591001 support approval of a Comirnaty booster dose administered at least 6 months after completion of the primary series for use in individuals 16 months of age and older?”

“I see someone has his hand raised. Do you have a question?”

Dr. X: Lips clearly moving but no sound.

Moderator: “Please unmute your mike” (Everyone was guilty of this oversight repeatedly throughout the day. One participant actually started speaking audibly and then leaned over and switched off his mike, possibly not to break the trend).

Dr. X: “Oh my, sorry about that. Arnie, we’re not sure on that part about “16 months and older.”

Dr. Monto: Oh yeah, I meant “at least 16 days and younger.”

Dr. X: Lips moving but no sound.

Moderator: “Unmute, please!”

Dr. X: “Oops, sorry! OK, Arnie. Does anyone know whether we’re supposed to vote on the time machine today, or will that be for the Advisory Committee on Immunization Practices?”

Christopher Lloyd: “I got that covered! Dang, I mislaid the keys to the DeLorean.”

We listened to those making short presentations at the open public hearing. They were each given about 3 minutes to make their statements. Some were in favor of the vaccine booster, others were not. Safety concerns were prominent, especially for giving vaccine boosters to children.

In fact, the committee seemed very ready to change the focus of the booster to place less specific emphasis on children. We imagine that’s part of the reason why the age range was adjusted away from specifying those 16 years and older (although they’ve probably been getting the primary series, even before the August approval of the Pfizer vaccine). One of the committee members asked, after the change of the age from “16 years” to “65 years” (but also specifying those at “high risk for severe disease”) whether that still meant a 16-year-old could get the booster. The answer was “yes.”

That made sense since children can have medical illnesses that increase their risk of serious complications from COVID-19 infection. But some committee members wondered about the 65 years of age cutoff, probably because they were not 65 years old. This and other speculations about how to specify the vulnerable population led to scrambling to get the meeting over because this was a question which the ACIP could clarify—and because it was getting very close to the end of the day.

We still don’t know when the ACIP is going to meet about the booster. They’ve added something for September 22 and 23, but I don’t find an agenda for it yet. Maybe they’ll have sausages for lunch.