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Vaccine myocarditis update from Korea

BY ANISH KOKA

A national study from Korea published in the European Heart Journal sheds important new light on complications related to COVID vaccine related myocarditis. While US public health authorities have been convinced from the very beginning about how safe and effective the new vaccines are, researchers in other countries with far smaller budgets have been testing that theory.

It was Israeli researchers that first highlighted the novel mRNA vaccines as potentially causing myocarditis in the Spring of 2021, but it has proven difficult to quantify the risk of severe complications beyond scattered case reports of severe morbidity and mortality. In part, US researchers are hampered by vaccine reporting systems in the US that are passive surveillance systems relying on voluntary reporting of vaccine adverse events. This has the potential of under-reporting adverse events, which was exactly the conclusion of an earlier JAMA analysis on US VAERS vaccine myocarditis cases.

Diving deep into the methods and results of the study

The South Korean approach was to organize a national reporting system under the auspices of the Korean Disease Control and Prevention Agency (KDCA). The KDCA also established a reporting system with a legal obligation for special adverse events including myocarditis and pericarditis after COVID-19 vaccination. To evaluate all reported cases of suspected myocarditis or pericarditis after COVID-19 vaccination, the KDCA organized an “Expert Adjudication Committee on COVID-19 Vaccination Pericarditis/Myocarditis”. The committee comprised 7 experts in cardiology, 1 in infectious disease, 2 in epidemiology, epidemiologic investigators in 16 regional centers, and officials from the KDCA.

Among 44,276,704 subjects vaccinated from 26 February to 31 December 2021, 1533 cases of suspected myocarditis were reported to the KDCA. The committee adopted the myocarditis case definition and classification of the Brighton Collaboration (BC) (see figure below) for the diagnosis and degree of certainty of a Vaccine Related Myocarditis (VRM) diagnosis.

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THCB Gang Episode 125, Thursday June 8

Joining Matthew Holt (@boltyboy) on #THCBGang on Thursday June 8 at 1PM PT 4PM ET are privacy expert Deven McGraw (@healthprivacy); Queen of employer benefits Jennifer Benz (@Jenbenz); THCB regular writer and ponder of odd juxtapositions Kim Bellard (@kimbbellard); and policy expert consultant/author Rosemarie Day (@Rosemarie_Day1);

You can see the video below & if you’d rather listen than watch, the audio is preserved as a weekly podcast available on our iTunes & Spotify channels.

Interview with Dr Pamela Tenaerts, Medable

Pam Tenaerts is the Chief Scientific Officer of Medable, which went from being a small company creating software helping clinical researchers to design their own experiments to being the big dog in remote clinical trials during the pandemic. Medable has raised over $500m in the past 3 years. Pam has a stellar research background and this interview covers the gamut about how clinical trials work, which companies are involved, how remote (or hybrid) trials actually work, and what the likely outcome for clinical research will be. If you have any interest in understanding the state of play in pharma R&D, this is compulsory viewing–Matthew Holt

Landed Gentry and Health

BY MIKE MAGEE

“The title of our lands is free, clear, and absolute, and every proprietor of the land is a princess his own domains, and lord paramount of the fee.” 

Jesse Root, 1798, Chief Justice of the Connecticut Supreme Court

When it came to social hierarchy and family position, land was the ultimate measure of success and influence in Great Britain. But by the time of the American Revolution, our Founders were already fast at work dismantling Primogeniture (“the right of succession belonging to the firstborn child, especially the feudal rule by which the whole real estate of an intestate passed to the eldest son.”) It had already largely disappeared in New England, and was gone in the southern colonies by 1800.

In its place, the colonists envisioned a “free and mobile market,” where land could be traded like money and other goods. To do so, the original land grants and “feudal tenures” were obliterated, and their legal documents swept clean by the new law of the land. The decisions on ownership were made locally, empirically and by “common wish” of those in power.

Property was meant to be traded, fast and furious, but most of all put to “productive use” in a young nation obsessed with rapid growth. As legal historian, Lawrence Friedman, suggested, “In land lay the hope of national wealth; for countless families, it was their chance to make some money. The land, once it was cleared of the native peoples (by hook or by crook), and properly surveyed, was traded with speed and fury. Speculation in raw lands was almost a kind of national lottery.”

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A Hand Up, Not a Hand-Out

BY KIM BELLARD

As many of you did, I followed the recent debt ceiling saga closely, and am relieved that we now have a compromise, of sorts.  The House Republicans demanded a lot of things, most of which they did not get, but one area where they did prevail was in toughening work requirements for food (SNAP) and income (TANF).  They somehow believe that there are uncounted numbers of “able-bodied” people sitting around on their couches collecting government benefits, a myth that goes back to Ronald Reagan’s welfare queen stereotype, and have long advocated work requirements as the remedy. 

Ironically, according to the CBO, the work requirements passed may actually increase federal spending by as much as $2b, and increase the number of monthly recipients by as many as 80,000 people, but who’s counting?  

All this seems timely because of some new studies that illustrate – once again — that, yes, poverty is bad for people’s health, and helping them get even a little bit more out of poverty improves their health.  

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Matthew’s health care tidbits: Hedge Funds that Do Health Care on the Side

Each time I send out the THCB Reader, our newsletter that summarizes the best of THCB (Sign up here!) I include a brief tidbits section. Then I had the brainwave to add them to the blog. They’re short and usually not too sweet! –Matthew Holt

Lots of news about bad behavior in health care this week, with real shots about patient & staff safety at home care company Papa, and Grail misinforming 400 people that they had cancer. But the prize for tone deafness this week comes from another very well funded health care provider system being heartless to its poorest patients. 

This week it’s Allina, a Minnesota “nice” system which actually amended its Epic system so that clinicians could literally not book appointments or provide care to patients who owed Allina money. Clinicians on the sharp end of this were so appalled that they went on the record about their own employer to NY Times’ reporter Sarah Kliff. The most egregious example was a doctor unable to write a prescription for a kid that had scabies–an infectious parasitic disease–who was sharing one bed with two other kids!

Of course Allina also is on the low end of charity care provision (below 1% of revenues). In contrast ten employees make more than $1m a year and another 10 make more than $500,000

We all know about egregious private equity funds investing in payday loans and other scummy outfits that prey on the poor. Turns out that if you let a non-profit hospital become beholden to its financial, rather than moral, north star, it starts to behave in a similar manner. Allina, of course, had a smidge under $4bn in its “investment reserve” at the end of 2021. It’s by no means special. UPMC has over $7bn in its reserves (unclear if this includes the investments it has made in startups), while Ascension has a formal private equity fund that controversially paid its former CEOs over $10m as part of its $18bn reserves.

Somehow having hedge funds that provide a little health care service on the side doesn’t leave the best taste in the mouth for how we should be organizing this health care system.

THCB Gang Episode 124, Thursday June 1

Joining Matthew Holt (@boltyboy) on #THCBGang on Thursday June 1 at 1PM PT 4PM ET were double trouble futurists Jeff Goldsmith and Ian Morrison (@seccurve), and delivery & platform expert Vince Kuraitis (@VinceKuraitis). Lots of discussion about Kaiser and Geisinger and what this means about the model for the future of care delivery. Do incentives or professionalism matter more?

The video is below. If you’d rather listen to the episode, the audio is preserved from Friday as a weekly podcast available on our iTunes & Spotify channels

Don’t Blame Burnout

BY SANJ KATYAL

It is hard to open a medical journal in any specialty without seeing an article on burnout. There are statistics, trends, and of course a myriad of causes detailed in these articles. A few even offer some sensible solutions – flexible scheduling, peer support, delegation of clerical work and an increased focus on personal well-being activities are steps in the right direction. 

I have previously written that “the absence of burnout does not equal wellness” just as the absence of disease does not imply health. We deserve more than simply the ability to function, we deserve to flourish. This is where a field such as positive psychology, or what many call the science of happiness, can offer some evidence-based guidance. 

What has become clear over the past few years is that many people are giving new buzzwords like burnout or moral injury too much credit for their unhappiness. Many of us are not well, either personally or professionally. It’s not as if we are joyful, peaceful and fulfilled at home and then suddenly begin to suffer only when we go to work. 

Our jobs, colleagues or even the draconian healthcare system are not to blame for our discontent. Many of us may feel burned out but it has little to do with our career choice. Not many of us are fulfilled. Not many of us are content. Not many of us are free of stress and anxiety. Most of us seem to be restless and want to feel better all the time. So we blame our jobs, our bank account, people around us, even the world, and call it burnout. Burnout, while a significant problem for some people is now conveniently being used by many to shift the blame away from ourselves. We are the problem. But the good new is that we are also the solution. It is our lack of understanding that causes us to feel perpetually discontent and  frantically chase happiness in various forms. It can only be understanding that will set us free. 

What is it that we have not understood? What are the questions deep within us that we never have the courage to ask?

Why are we not fulfilled? Why are we restless and anxious much of the time? Why do we crave distractions in phones, TV and alcohol?

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Designing (Healthcare) via Roblox

BY KIM BELLARD

Here’s a question: what medical schools are incorporating Roblox into their curriculum?  

Interested readers can get back to me, but in the meantime I’m guessing none.  At best, very few.  And instead of “medical schools” feel free to insert kind of “healthcare institutions/organization” that is interested in educating or training – which is to say, all of them.  By way of contrast, I was intrigued by the collaboration between Roblox and The Parsons School of Design. 

Perhaps you don’t know about Roblox, a creator platform whose vision is “to reimagine the way people come together to create, play, explore, learn, and connect with one another.”  As their website says: “We don’t make Roblox.  You do.” It claims to have almost 10 million developers using its platform, hosting some 50 million “experiences.”  

I first wrote about it in 2021, astonished that over half of American children used it, with some 37 million unique daily users. Today it has over 66 million unique daily users — some 214 million monthly active users.   The vast majority of the users – as much as 80% — are under 16, a fact Roblox is acutely aware of and is seeking to change.  

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Operation Searchlight: The American-supported Pakistani genocide you probably haven’t heard about

BY ANISH KOKA

On March 25th, 1971, the Pakistani army launched Operation Searchlight, a military campaign to brutally suppress a Bengali nationalist movement.

The roots of the genocide lie in the parting gift British rulers gave to the Indian subcontinent at the time of independence in 1947. British controlled India was separated into Hindu majority India and Muslim majority Pakistan. But because there were two dense non-contiguous Muslim majority areas in British controlled India, the muslim majority country of Pakistan was divided into East and West Pakistan.

East and West Pakistan were linked by religion, but little else. East Pakistan was culturally Bengali, and had much more in common with Bengali Hindus than Muslims in West Pakistan. While Bengalis took pride in their culture and language, West Pakistani’s looked down on the Bengali’s because it was deemed to be too influenced by Hindu culture. While Bengali muslims may have identified themselves with Pakistan’s islamic project, by the 1970s many in East Pakistan had given priority to their Bengali ethnicity over their religious identity, desiring a society more in accordance with Western principles of secularism and democracy. A growing opposition in East Pakistan strongly objected to the Islamist paradigm being imposed the West Pakistani state.

But West Pakistan controlled the military, and formed much of the ruling elite after the partition in 1947. In a move designed to send a message to Bengali speaking East Pakistani’s , the founding father of Pakistan, Muhammad Jinna even made Urdu the national language of all of Pakistan, and branded those opposed as enemies of the State.

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