CDC Identifies Preliminary Covid-19 Vaccine Safety Signal

The CDC announced that a prelimary Covid-19 Vaccine Safety signal has been identified in a recent update on their website:

“Following the availability and use of the updated (bivalent) COVID-19 vaccines, CDC’s Vaccine Safety Datalink (VSD), a near real-time surveillance system, met the statistical criteria to prompt additional investigation into whether there was a safety concern for ischemic stroke in people ages 65 and older who received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Rapid-response investigation of the signal in the VSD raised a question of whether people 65 and older who have received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-42 following vaccination.

This preliminary signal has not been identified with the Moderna COVID-19 Vaccine, Bivalent. There also may be other confounding factors contributing to the signal identified in the VSD that merit further investigation. Furthermore, it is important to note that, to date, no other safety systems have shown a similar signal and multiple subsequent analyses have not validated this signal:

  • A large study of updated (bivalent) vaccines (from Pfizer-BioNTech and Moderna) using the Centers for Medicare and Medicaid Services database revealed no increased risk of ischemic stroke
  • A preliminary study using the Veterans Affairs database did not indicate an increased risk of ischemic stroke following an updated (bivalent) vaccine
  • The Vaccine Adverse Event Reporting System (VAERS) managed by CDC and FDA has not seen an increase in reporting of ischemic strokes following the updated (bivalent) vaccine
  • Pfizer-BioNTech’s global safety database has not indicated a signal for ischemic stroke with the updated (bivalent) vaccine
  • Other countries have not observed an increased risk for ischemic stroke with updated (bivalent) vaccines”

The CDC says it’s “very unlikely  that the signal in VSD represents a true clinical risk…” The data and additional analyses will be discussed at the January 26, 2023 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.

No changes are recommended to the current Covid-19 vaccination practice:

“CDC continues to recommend that everyone ages 6 months of age and older stay up-to-date with COVID-19 vaccination; this includes individuals who are currently eligible to receive an updated (bivalent) vaccine. Staying up-to-date with vaccines is the most effective tool we have for reducing death, hospitalization, and severe disease from COVID-19, as has now been demonstrated in multiple studies conducted in the United States and other countries:

  • Data have shown an updated COVID-19 vaccine reduces the risk of hospitalization from COVID-19 by nearly 3-fold compared to those who were previously vaccinated but have not yet received the updated vaccine.
  • Data have shown that the updated COVID-19 vaccine also reduces the risk of death from COVID-19 by nearly 19-fold compared to those who are unvaccinated.
  • Other preliminary data from outside the U.S. have demonstrated more than 80% protection against severe disease and death from the bivalent vaccine compared to those who have not received the bivalent vaccine.

Overall safety data for the bivalent COVID-19 vaccines are available here.

Once again, no change is recommended in COVID-19 vaccination practice, which can be found here.”

Bivalent Covid-19 Booster Protects Us

University of Iowa Health Care participated in research which demonstrates that people over age 65 who got the updated bivalent Covid-19 vaccine booster:

  • “84% less likely to be hospitalized with COVID-19 compared with unvaccinated people 
  • 73% less likely to be hospitalized with COVID-19 compared with people who received monovalent mRNA vaccination alone but had not received the bivalent booster dose.”

Amaryllis and Zygocactus Repotting

Remember that gorgeous Christmas Amaryllis flower? After it leaned over so far, we had to retire it, so to speak. We didn’t throw it out, but Sena kept it and performed some kind of miracle.

Apparently, she resurrected it by giving it a little water. A couple of new leaves grew a few inches overnight.

She knows that gardeners tell you to bury the Amaryllis bulb outside after the flowers die. I guess in the following winter you dig it up, put it in a new pot and a new set of blossoms should grow. She wanted to transfer it to a different pot instead, one with holes that will let the excess water leak out.

She was very industrious. She also repotted the Zygocactus. That’s the holiday cactus, another houseplant she got for the Christmas holidays.

And the most important question: how are extraterrestrials involved in this urge to repot? ? By the way, I was not involved in the repotting project because I’m allergic to gardening. I did make a YouTube video of her working on it, though.

An Old Post on Breaking Bad News

I’m reposting a piece about a sense of humor and breaking bad news to patients I first wrote for my old blog, The Practical Psychosomaticist about a dozen years ago. I still believe it’s relevant today. The excerpt from Mark Twain is priceless. Because it was published before 1923 (See Mark Twain’s Sketches, published in 1906, on google books) it’s also in the public domain, according to the Mark Twain Project.

Blog: A Sense of Humor is a Wonderful Thing

Most of my colleagues in medicine and psychiatry have a great sense of humor and Psychosomaticists particularly so. I’ll admit I’m biased, but so what? Take issues of breaking bad news, for example. Doctors frequently have to give their patients bad news. Some of do it well and others not so well. As a psychiatric consultant, I’ve occasionally found myself in the awkward position of seeing a cancer patient who has a poor prognosis—and who apparently doesn’t know that because the oncologist has declined to inform her about it. This may come as a shock to some. We’re used to thinking of that sort of paternalism as being a relic of bygone days because we’re so much more enlightened about informed consent, patient centered care, consumer focus with full truth disclosure, the right of patients to know and participate in their care and all that. I can tell you that paternalism is not a relic of bygone days.

Anyway, Mark Twain has a great little story about this called “Breaking It Gently”. A character named Higgins, (much like some doctors I’ve known) is charged with breaking the bad news of old Judge Bagley’s death to his widow. She’s completely unaware that her husband broke his neck and died after falling down the court-house stairs.  After the judge’s body is loaded into Higgins’ wagon, Higgins is reminded to give Mrs. Bagley the sad news gently, to be “very guarded and discreet” and to do it “gradually and gently”. What follows is the exchange between Higgins and the now- widowed Mrs. Bagley after he shouts to her from his wagon[1]:

“Does the widder Bagley live here?”

“The widow Bagley? No, Sir!”

“I’ll bet she does. But have it your own way. Well, does Judge Bagley live here?”

“Yes, Judge Bagley lives here”.

“I’ll bet he don’t. But never mind—it ain’t for me to contradict. Is the Judge in?”

“No, not at present.”

“I jest expected as much. Because, you know—take hold o’suthin, mum, for I’m a-going to make a little communication, and I reckon maybe it’ll jar you some. There’s been an accident, mum. I’ve got the old Judge curled up out here in the wagon—and when you see him you’ll acknowledge, yourself, that an inquest is about the only thing that could be a comfort to him!”

That’s an example of the wrong way to break bad news, and something similar or worse still goes on in medicine even today. One of the better models is the SPIKES protocol[2]. Briefly, it goes like this:

Set up the interview, preferably so that both the physician and the patient are seated and allowing for time to connect with each other.

Perception assessment, meaning actively listening for what the patient already knows or thinks she knows.

Invite the patient to request more information about their illness and be ready to sensitively provide it.

Knowledge provided by the doctor in small, manageable chunks, who will avoid cold medical jargon.

Emotions should be acknowledged with empathic responses.

Summarize and set a strategy for future visits with the patient, emphasizing that the doctor will be there for the patient.

Gauging a sense of humor is one element among many of a thorough assessment by any psychiatrist. How does one teach that to interns, residents, and medical students? There’s no simple answer. It helps if there were good role models by a clinician-educator’s own teachers. One of mine was not even a physician.  In the early 1970s when I was an undergraduate at Huston Tillotson University (when it was still Huston-Tillotson College), the faculty would occasionally put on an outrageous little talent show for the students in the King Seabrook Chapel. The star, in everyone’s opinion, was Dr. Jenny Lind Porter, who taught English. The normally staid and dignified Dr. Porter did a drop-dead strip tease while reciting classical poetry and some of her own ingenious inventions. Yes, in the chapel. Yes, the niece of author O. Henry; the Poet Laureate of Texas appointed in 1964 by then Texas Governor John Connally; the only woman to receive the Distinguished Diploma of Honor from Pepperdine University in 1979; yes, the Dr. Porter in the Texas Women’s Hall of Fame—almost wearing a very little glittering gold something or other.

It helps to be able to laugh at yourself.

1.       Twain, M., et al., Mark Twain’s helpful hints for good living: a handbook for the damned human race. 2004, Berkeley: University of California Press. xiv, 207 p.

2.       Baile, W.F., et al., SPIKES-A six-step protocol for delivering bad news: application to the patient with cancer. Oncologist, 2000. 5(4): p. 302-11.

Men in Black Movie Marathon

Sena and I have favorite movies. We both like “Up” and “WALL-E.” My favorites are the Men in Black trilogy. That doesn’t mean I think the 4th sequel was bad. But I have lost count of the number of times I’ve watched the first three.

I haven’t watched them in the last several months because I couldn’t find them on cable for some reason. I’ve just learned that that there will be a marathon of the trilogy on January 14, 2023 beginning at 2:30 PM. They’ll be on the Comedy Central channel.

I’m a fan of comedy and I like the chemistry between the two main characters, Agent J and Agent K.

I have favorite lines from each movie. In the first Men in Black film, I like the exchange between the two agents after the recruitment scene following Edwards’ (the soon to be Agent J) first visit to the MIB Headquarters. They’re sitting on a park bench and K is talking about people and what they don’t know about them and extraterrestrials.

Edwards: Why the big secret? People are smart. They can handle it.

Agent K: A person is smart. People are dumb, panicky, dangerous animals and you know it. Fifteen hundred years ago, everybody knew the Earth was the center of the universe. Five hundred years ago, everybody knew the Earth was flat, and fifteen minutes ago, you knew that humans were alone on this planet. Imagine what you’ll know tomorrow.

Another favorite where Agent K is showing Edwards a universal translator, one of the many wonders in the extraterrestrial technology room, which gives us a perspective on how humans rank in the universe:

Agent K: We’re not even supposed to have it. I’ll tell you why. Human thought is so primitive it’s looked upon as an infectious disease in some of the better galaxies.

In MIB II, the dialogue between Newton and the Agents makes you wonder what extraterrestrials really want from us:

Newton: Gentlemen, before I play the tape, there’s just one question I need to ask; what’s up with anal probing? I mean, aliens travel billions of light years just to check out our…

Agent J: Boy, move!

This is part of the Men in Black 3 dialog between Agent J and Jeffrey Price about how to use the time travel device:

Jeffrey Price: Do not lose that time device, or you will be stuck in 1969! It wasn’t the best time for your people. I’m just saying. It’s a lot cooler now.

I remember 1969. Things are not perfect now, but they are better. What we don’t need is a “big ass neutralizer.” As long as we remember what dark times were like, we have a chance to make cooler times.

New Season for Highway Thru Hell

There was a countdown on Sunday for the new season for Highway Thru Hell. That’s the explanation for the featured image. The show has been on a while; this is season 11.

Season 11, for the first few episodes will deal with the catastrophic floods that devastated British Columbia in November of 2021. It took a huge toll on everybody, including the tow truck businesses. That’s one reason why I think, out of the plethora of reality shows that are faked on TV—Highway Thru Hell is not.

There are times when I wondered about the show’s authenticity, of course. One episode featured a potential new hire named “Jack Knife,” which brings to mind what the heavy tow trucks do, which is to drag huge jack-knifed semi-trucks out of ditches along the highways. The episode actually showed a segment of Jamie Davis, the owner of the major tow truck business on the show, in which he confirms that Jack Knife is the guy’s real name. It doesn’t look like he was hired.

There is a kind of irony about the kinds of jobs I’ve had and how similar or not they were to the Highway Thru Hell type of work.

You’d think that when I was working as a survey crewman back when I was a young, I would think it was similar to Highway Thru Hell. In fact, I worked for professional consulting engineers. I had a regular schedule with set hours. I had the right equipment for the right job. When work slowed down, meaning the company didn’t have a big contract for a highway relocation or whatnot, I and other guys would fill the time and to look busy, we would tie up redheads.

I’ve set up that joke before. We didn’t tie up red-headed women. You tied red ribbon as flagging around nails to use as measuring points for property or airport runway lines and the like. It makes them easier to see. If you were lucky and had some drafting skills, like me, in the winter months you’d work on drawing up survey plots and other plans for blueprints. I worked in pretty bad weather sometimes, in the winter. I never had to do anything that was dangerous. I got plenty of sleep.

But I never worked as hard as tow truck operators. When it’s slack time for them, some are laid off, which is never a good thing. But when they’re busy, they’re up all day and sometimes all night. The calls to haul trucks out of the ditch are unpredictable. And the conditions are always dangerous.

The irony is that it wasn’t until after I graduated medical school, got my medical license, and finished my residency in psychiatry that, as I look back on it now, that my work sort of resembled the chaos of workers on Highway Thru Hell. And being on call as a resident did sometimes result in my face nearly falling in my dinner because of sleep deprivation.

Like Highway Thru Hell, working as a psychiatric consultant was a lot like being like a fireman, which is similar to towing. I got called, often to emergencies, and had to work in conditions which were dangerous, mainly because of violent patients. Like towing, the work load was feast or famine. The job often called for creative solutions to apparently impossible challenges.

Much of the time, the Highway Thru Hell workers’ worst enemy was Mother Nature, just as it was in during the catastrophic floods of November 2021. For many psychiatrists and other physicians, it seems like the worst enemy was burnout, especially during the Covid-19 pandemic.

There is no quick fix in either case. We can work together and help each other.

I Offered to Make Dinner But…

Yesterday I offered to make dinner, but Sena made a counteroffer I couldn’t refuse. She made a special dish of big meatballs (which she did not allow me to juggle) and potatoes. She makes an out-of-this-world sauce that she must have got from Extraterrestrials back in the early 1980s. The image from pixabay doesn’t do it justice, but we ate it too fast for me to get a snapshot.

I can’t remember the last time she made it; it has been years.

As a matter of full disclosure, while I did offer to make dinner, “making dinner” for me is sticking a frozen pizza in the oven. I might throw a light salad into the bargain, but the whole affair is a far cry from actually making the pizza dough and getting my hands dirty. That almost never happens unless the moon splits in two.

I will occasionally add a little extra provolone to a Jack’s Pizza, a brand which tends to be a little light on toppings. My favorites are the Screamin’ Sicilian and Lotzza Motzza. I don’t need to add anything because they’re already loaded. Sena goes around to all the grocery stores in town when they have reduced prices, but restrict you so you can buy only 2 at one store.

Also, I’ll prepare soup—if I can figure out how to open the can.

I can’t give away the recipe without incurring some form of special punishment which might involve sharp objects and a chase across the state. It includes a lot of butter, for which she used creamery butter sculpted in the shape of a Christmas tree. There are unspecified amounts of ketchup, brown sugar, and a variety of spices which are probably not native to this planet. She keeps them in a locked drawer from which loud growls erupt if I get too close.

Even if I knew the recipe, if I tried to make it, the dish would end up tasting a lot like pizza.

Giving Credit Where Credit is Due

Here’s another vintage post from around a decade ago after my former Psychiatry Dept chairperson, Dr. Robert G. Robinson and I published our book, Psychosomatic Medicine: An Introduction to Consultation-Liaison Psychiatry” in 2010.

Blog: Who Gets The Credit?

When I think about peak moments, I remember this guy back in junior high school who decided to try to break the Guinness Book of World Records for skipping rope. I don’t remember his name but the school principal and his teachers all agreed to let him do it during class hours. They marked out a little space for him in our home room. He was at it all day. And he was never alone because there was always a class in the room throughout the day. We didn’t get much work done because we couldn’t keep our eyes off him. It was mesmerizing. The longer he jumped, the more we hoped. We were very careful about how we encouraged him. We didn’t want to distract him and make him miss a jump. And so, we watched him with hope in our hearts. It was palpable.  As he neared the goal, we were all crowded around him, teachers and students cheering. He was exhausted and could barely swing the rope over his head and lift his knees. When he made the time mark, we lifted him high above our heads and you could have heard us yelling our fool heads off for miles. Time stood still. He was a hero and we were his adoring fans. It didn’t occur to us to be jealous. His achievement belonged to all of us.

Another peak moment occurred more recently, when my colleagues and I published a book this summer. It’s my first book. It’s a handbook about consultation-liaison psychiatry which my department chairman and I edited, and the link is available on this page. This time, the effort was collaborative with over 40 contributors. The work took over 2 years and often, being an editor felt like herding cats. But we worked on it together. Many of the contributors were trainees working with seasoned psychiatrists who had much weightier research and writing projects on their minds, I’m sure. Like any first book, it was a labor of love. The goal was to teach fundamental concepts and pass along a few pearls about psychosomatic medicine to medical student, residents, and fellows. The book grew slowly, chapter by chapter. And when it was finally complete, this time the achievement was ours and again it belonged to all of us.

I made a lot of long-distance friends on the book project and occasionally get encouragement to do something else we could work together on. I suppose one thing everyone could do is to propose some kind of delirium early detection and prevention project at their own hospitals and chronicle that in a blog to raise awareness about delirium—sort of like what I’ve been trying to do here. We could share peak moments like:

  1. Getting the Sharepoint intranet site up and going so that group members can talk to each other about in discussion groups about how to hammer out a proposal, which delirium rating scale to use, or which management guidelines to use—and avoid the email storms.
  2. Being invited to give a talk about delirium at a grand rounds conference or regional meeting.
  3. Talking with someone who is interested in funding your delirium project (always a big hit).

That way if one of us falters, we always know that someone else is in there pitching. Copyrighting ideas and tools are fine. Hey, everybody has a right to protect their creative property. I’m mainly talking about sharing the idea of a movement to teach health care professionals, and patients about delirium, to help us all understand what causes it, what it is and what it is not, and how to prevent it from stealing our loved ones and our resources.

“It is amazing what you can accomplish if you do not care who gets the credit”-Harry Truman, Kansas Legislature member John Solbach, Ronald Reagan, Charles E. Montague, Benjamin Jowett, a Jesuit Father, a wise man, Edward T. Cook, Edward Everett Hale, a Jesuit Priest named Father Strickland.