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Cardiology update: Should mRNA vaccine myocarditis be a contraindication to future COVID-19 vaccinations ?

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BY ANISH KOKA

Myopericarditis is a now a well reported complication associated with Sars-Cov-2 (COVID-19) vaccinations. This has been particularly common with the messenger RNA (mRNA) vaccines (BNT162b2 and mrna-1273), with a particular predilection for young males.

Current guidance by the Australian government “technical advisory groups” as well as the Australian Cardiology Society suggest patients who have experienced myocarditis after an mRNA vaccine may consider a non-mRNA vaccine once “symptom free for at least 6 weeks”.

A just published report of 2 cases from Australia that document myopericarditis after use of the non-mRNA Novavax vaccine in patients that had recovered from mRNA vaccine myocarditis suggests this is a very bad idea.

The case reports

Case 1 involves a 26 year old man who developed pericarditis after the Pfizer vaccine. Pericarditis, an inflammation of the sac the heart lives in, developed about 7 days after the Pfizer vaccine. The diagnosis was made based on classic findings of inflammation on an electrocardiogram associated with acute chest pain. The symptoms lasted 3 months, and a total of 6 months after the first episode of pericarditis, he received a booster vaccination with the Novovax (NVX-CoV2373) vaccine. 2-3 days after this he developed the same sharp chest pain and shortness of breath with elevated inflammatory markers (CRP) as well as typical findings of pericarditis seen on ECG. To add insult to injury, he contracted COVID 2 months after the second episode of pericarditis, but had no recurrence of the symptoms of pericarditis.

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Ultrasound is Ultra-Cool

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BY KIM BELLARD

AI continues to amaze – ChatGPT is now passing Wharton Business School exams, Microsoft and Google are doubling down in their AI efforts – and I’m as big a fan as anyone, but I want to talk about a technology that has been more under the radar, so to speak: ultrasound.  

Yes, ultrasound.  Most of us have probably had an ultrasound at some point (especially if you’ve been pregnant) and Dr. Eric Topol continues his years-long quest to replace the ancient stethoscope technology with ultrasound, but if you think ultrasound is just another nifty tool in the imaging toolbox, you’ve missed a lot. 

Let’s start with the coolest use I’ve seen: ultrasound can be used for 3D printing.  Inside the body.  

This news on this dates back to last April, when researchers from Concordia University published their findings in Nature (I found out about it last week).  Instead of the more common “Additive Manufacturing” (AM) approach to 3D printing, these researchers use Direct Sound Printing (DSP).  

The paper summarizes their results: “To show unique future potentials of DSP, applications such as RDP [Remote Distance Printing] for inside body bioprinting and direct nanoparticle synthesizing and pattering by DSP for integrating localized surface plasmon resonance with microfluidics chip are experimentally demonstrated.”

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Matthew’s health care tidbits: My retina & what it tells us about primary care

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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

I had a little scare the other night. I was driving home from a weekend in the mountains and I asked my wife if she saw that flashing light. No it wasn’t the cops, and no she hadn’t seen it. Turns out that I had a bright flash if I moved my eye a certain way. Oh, well I assumed I was tired and a good night’s sleep would fix it.

Next morning the flash was still there when I looked quickly to the left and a few weird floaters had appeared. I headed to the Mayo Clinic website and it looked to me like I had a detaching retina. I got on the urgent visit video with One Medical. The NP who answered said it sounded like I might have retina problems and I should get it checked by my ophthalmologist. But my eyesight has always been great (other than me needing reading glasses in my old age) and I haven’t got one. So who, I asked, do you recommend?

Here we fall into the crux of the problem. One Medical is an excellent primary care service. So good that Amazon bought it for $3bn. But it’s not a multi-specialty group nor is it a system like Kaiser. The answer was, “we don’t really recommend anyone–that’s not how it works.” The NP ended up looking up ophthalmologists near me & sent me a name as a referral in their app. But that’s not a link to anything and it wasn’t one chosen through some analytical process of seeking quality excellence.

I looked up MarinHealth (my local hospital)’s website and searched ophthalmology. That referred name was on it. I called. The doctor was out this week. They gave me another name. That doctor’s office gave me another name and that third office could see me that same day. I felt some pressure to see them right away as in the case of a detached retina Mayo says “ Contacting an eye specialist (ophthalmologist) right away can help save your vision”. The good news is having spent a couple of hours at the ophthalmologist’s my retina needs watchful waiting not surgery.

But the bad news is that for me, like 90% of Americans, there’s no easy way to get referred into a trustworthy system for specialty care. This can be even worse. My friend Sarah McDonald explains in her book The Cancer Channel how, after being diagnosed with a rare incurable cancer by a head & neck surgeon, the all encompassing support she received was to be given the number of a specialist at UCSF who couldn’t even talk to her for 3 weeks.

Mike Magee talks about the role of the health care system being to reduce patients’ “fear and worry”. Our lack of a specialty care referral system, especially when potentially serious and urgent care is on the line, is a big reason why there is so much fear and worry. I wish I had a concierge advocacy system like Included Health or Transcarent which could get me to the right place and work with me through the experience. But like most Americans at the time I need reassurance the most I’m calling a list of phone numbers hoping someone can see me.

We have primary care, we have specialty care. But we don’t have a system that cares.

Can Missouri Pass The Muster

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BY MIKE MAGEE

A case has been made that a logical approach to reforming America’s violent and racist leanings would be to adopt the values and practices of Health Care for All. These include a commitment to compassion, understanding, and partnership; extending the linkages between individual, family, community and society; addressing fear and worry for individuals and populations; and promoting an optimistic and equitable future for all Americans. 

Nurses and doctors and pharmacists and other health professionals pledge oaths and spend years training to exhibit and practice these values in the course of providing preventive and interventional care to select Americans. Imagine the effect of delivering these many benefits in an equitable way, in all communities, with the intent of making not only Americans, but also the American culture healthy.

Or we could simply continue to accept the values exhibited by the Missouri State Legislature, where misogyny and brass knuckles have risen to the top of their legislative calendar.

In June, 2021, a Missouri News-Press editorial commented that “one vote last week might strike some as a sign that Missouri’s lawmakers could use some help with time management and prioritization.” The Republican led body had soundly passed HB 1462 which included Section 571.020 and 571.107 which read “This act repeals prohibitions on the possession and selling of brass knuckles, firearm silencers, and switchblade knives.” The same act addressed the taxpayer burden for possession of their weaponry by providing “that all sales of firearms and ammunition made in this state shall be exempt from state and local sales taxes.”

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Medicare Advantage UpCoding Has Been Eliminated by CMS Effective 2022

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By GEORGE HALVORSON

Medicare Advantage now enrolls almost exactly half the people enrolled in Medicare — and has both significant fans and hardline opponents in the health care policy circles who disagree about its performance.

The biggest attack point that comes from the critics deals with the issues of coding accuracy by the plans. The payment model for the program is capitation — and that capitation is based on the average cost of fee-for-service Medicare in every county. The people who designed the model believed that the country should use the average cost of fee-for-service Medicare in every county as the baseline number and should have the plans paid less than that average Medicare cost going forward every year in their capitation cash flow.

Medicare fee-for-service has a strict and consistent payment level based on a list of approved Medicare services — and they add up the cost of those services in every county and let the plans bid a lower number than that fee for service Medicare cost, if the plans believe they can offer all of the basic benefits and possibly add more benefits and additional services for that amount.

The fee-for-service Medicare cash flow and costs in each county tend to be very stable over time, with a continuous and steady increase in the actual functional cost for taking care of those fee-for-service patients for each year that they receive care. That total cost of fee-for-service Medicare care is a visible and clear baseline number that we can use each year with confidence and knowledge that it is what we are spending now on those Medicare members in the counties.

The direct capitation amount that is then paid to each of the plans is based on the age, gender, health status, and diagnosis profile of the Medicare Advantage members who enroll in the plans. The plans have been reporting those patient profile numbers to the government through the Risk Adjustment Processing System (RAPS) over a couple of decades to set up their payment levels and to create the monthly cash flow for each plan.

That’s where the upcoding accusations relative to the plans arise.

The plans get paid more if the patients have more expensive diagnoses — so the plans have had a strong and direct incentive to make sure that every diabetic enrollee is recorded and reported as being diabetic for their RAPS filings.

They also have a strong incentive to be sure that every congestive heart failure patient has their diagnosis recorded in their RAPS report.

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Fighting the Wrong (Culture) War

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By KIM BELLARD

News flash from the culture wars: they’re coming to take our gas stoves!

Well, actually, “they” are not, but the kind of people who got alarmed about it are a threat to our health, and to theirs.

The gas stove furor started with a Bloomberg News interview that Richard Trumka, Jr, a Consumer Product Safety Commission commissioner. “This is a hidden hazard,” he said. “Any option is on the table. Products that can’t be made safe can be banned.”

He was referring to the well known but little acknowledged fact that gas stoves emit various pollutants, especially nitrogen dioxide. Last year the AMA adopted resolutions about the risks of gas stoves, and urged migration efforts to electric stoves. Shelly Miller, a University of Colorado, Boulder, environmental engineer has said:

Cooking is the No. 1 way you’re polluting your home. It is causing respiratory and cardiovascular health problems; it can exacerbate flu and asthma and chronic obstructive pulmonary disease in children…you’re basically living in this toxic soup.

So one can see why the CPSC might be concerned. But the outcry about Mr. Trumka’s comments were immediate and vociferous. “I’ll NEVER give up my gas stove. If the maniacs in the White House come for my stove, they can pry it from my cold dead hands. COME AND TAKE IT!!” Rep. Ronny Jackson (R-TX) tweeted. The Atlantic further reported:

Governor Ron DeSantis tweeted a cartoon of two autographed—yes autographed—gas stoves. Representative Jim Jordan of Ohio declared simply, “God. Guns. Gas stoves.” Naturally, Tucker Carlson got involved. “I would counsel mass disobedience in the face of tyranny in this case,” he told a guest on his Fox News show.

Almost as immediately, Mr. Trumka clarified: “To be clear, CPSC isn’t coming for anyone’s gas stoves. Regulations apply to new products.” CPSC Chair Alexander Hoehn-Saric issued a statement making it clear that, while “emissions from gas stoves can be hazardous…I am not looking to ban gas stoves and the CPSC has no proceeding to do so.” The White House issued its own denial. Case closed, right?

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The Open Data Movement Runs Aground on FOURIER

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BY ANISH KOKA

Reanalysis of a trial used to approve a commonly used injectable cholesterol-lowering drug confirms the original analysis by accident.

The open-data movement seeks to liberate the massive amount of data generated in running clinical trials from the grasp of the academic medical-pharmaceutical industrial complex that mostly runs the most important trials responsible for bringing novel therapeutics to market.

There are only a few elite academic trialist groups capable of running large trials and there’s ample reason to be suspicious about the nexus that has developed between academia and the pharmaceutical companies that shower them with cash to hopefully get a positive study result and pay off the pharmaceutical research investment manifold. The FDA is the major regulator of the whole process, but the expertise required for regulation means that the FDA is frequently comprised of ex-pharma employees or ex-academics.

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At CES, A Tractor And A Patient Stethoscope Point To Digital Health Future

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By MICHAEL MILLENSON

A Deere tractor developed in Moline, Illinois and a stethoscope-for-patients from Singapore pointed to the future of digital health at CES 2023, the Consumer Technology Association gathering that’s become a global innovation hub.

The tractor appeared on a large video screen during the opening keynote by Deere & Company chief executive officer John May. The industrial company exec clearly relished the chance to trumpet the way Deere had turned tractors into high-tech tools to optimize farmers’ outcomes ­– an accomplishment inspiring envy among medical information mavens hoping to similarly transform patients’ outcomes.

“The John Deere presentation was one of the best technological presentations I have ever seen,” enthused ResMed chief medical officer Dr. Carlos Nunez at a later panel. Nunez pointedly noted that “you think health care would be difficult,” yet here Deere had revolutionized a centuries-old, rural, agrarian, manual profession.

Deere’s “smart machines” incorporate computer vision, soil moisture sensing, GPS with precise signal correction, machine learning and cloud computing, all of which enable farmers to plant corn, cotton and other crops “with precision beyond human capacity.” Farmers can track the tractor’s data collection with their smartphone and make real-time adjustments. In health care terms, that all adds up to personalized, evidence-based farming.

The technology gap between physicians and farmers is actually wider than May let on.

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The Danger of Stroking a Tiger

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By MIKE MAGEE

On the evening of December 29, 1940, with election to his 3rd term as President secured, FDR delivered these words as part of his sixteenth “Fireside Chat”: “There can no appeasement with ruthlessness…No man can tame a tiger into a kitten by stroking it.”

Millions of Americans, and millions of Britons were tuned in that evening, as President Roosevelt made clear where he stood while carefully avoiding over-stepping his authority in a nation still in the grips of a combative and isolationist opposition party.

The Germans were listening as well and sent a different type of message as the Luftwaffe, in concert with the address, launched their largest yet raid on the financial district of London. Their “fire starter” group, KGr 100, initiated the attack with incendiary bombs that triggered fifteen hundred fires that began a conflagration ending in what some labeled the “Second Great Fire of London.”

There was nothing happenstance about the timing or methods of the attack. The night was moonless, keeping RAF fighters lacking air-to-air radar grounded. There were high winds to fan the flames that night. High explosive bombs were used to target water mains to hamper fire fighters, and the Thames was at low tide making accessing it for a water supply neigh impossible.

Combined with Roosevelt’s words, the actions of December 29, 1940, now 82 years later, highlight two truisms when confronting evil orchestrated at the hands of racist, autocratic leaders.

First, appeasement does not work. It expands the vulnerability of a majority suffering the “tyranny of the minority.”

Second, the radicalized minority will utilize any weapon available, without constraint, to maintain and expand their power.

The battle to save democracy in these modern times has not been won. As was FDR at the time of his address, we are in the early years of this deadly serious conflict, and still in catch-up mode, awakened from a self-induced slumber on January 6, 2020.

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