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A big data COVID train wreck

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BY ANISH KOKA

If there was any doubt the academic research enterprise is completely broken, we have an absolute train wreck of a study in one of the many specialty journals of the Journal of the American Medical Association — JAMA Health.

I had no idea the journal even existed until today, but I now know to approach the words printed in this journal to the words printed in supermarket tabloids. You should too!

The paper that was brought to my attention is one that purports to examine the deleterious health effects of Long COVID. A sizable group of intellectuals who are still socially distancing and wearing n95s live in fear of a syndrome that persists long after a person recovers from COVID. There are any number of papers that argue a variety of putative mechanisms for how an acute COVID infection may result in long term health concerns. This particular piece of research that is amplified by the usual credentialed suspects on social media found “increased rates of adverse outcomes over a 1-year period for a PCC (post-COVID conditions) cohort surviving the acute phase of illness.”

In this case PCC (Post-COVID conditions), is the stand-in for Long COVID, and leading commentators use this paper to explicitly state that heart attacks, strokes and other major adverse outcomes doubled in people post-COVID at 1 year…

It is a crazy statement, and anyone regurgitating this has no business commenting on any scientific papers. Let me explain why.

In order to find out about the potential ravages of long COVID researchers need to be able to compare outcomes between those who were infected with COVID and now have long covid to those who were never infected with COVID. At this point finding a large enough group of people that never had covid is impossible, because everyone in the world will have been infected with COVID many, many times. It’s also really hard to define the nebulous long COVID because a study after study finds no clear objective markers of the disease.

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A COVID-19 vaccine exemption letter

BY ANISH KOKA

I recently saw a young man who came to see me because his place of future employment, a large health system was requiring him to complete the 1º series of his COVID-19 vaccination. He was concerned because he had chest pain after his first mRNA vaccine and was uncomfortable with the risks of a second mRNA dose. He attempted to get a Johnson and Johnson vaccine and was told by pharmacists he was not allowed to mix and match this particular vaccine as he had already received an mRNA dose. With no other option, he came to ask me whether I thought a vaccine exemption was reasonable in his case. He already had a family medicine physician sign an exemption that had been denied by his future employer’s vaccine exemption committee. The young man works on the “back end” of the health system remotely from home and he has no patient contact. The entire process has caused him to lose his health insurance from his former employer, and he was now paying out of pocket for an expensive COBRA health insurance plan. What follows is my letter to the vaccine exemption review committee regarding his case. (Published with permission, only the relevant names have been changed/redacted)


Dear Vaccine Exemption Review Committee,

I am writing this letter on behalf of John Smith DOB: xx/xx/xx in regard to a mandate from xxxx Health that Mr. Smith receive a second dose of an mRNA vaccine to complete his primary COVID-19 vaccine series.

Mr. Smith has asked me to render an opinion specifically related to his cardiac risk of receiving a second dose of an mRNA vaccine. I am a board-certified cardiologist in Philadelphia, Pennsylvania, and have been in active clinical practice for 13 years.

After reviewing the details of his case, I have grave concerns about compelling him to receive a second dose of an mRNA vaccine and would like to outline the reasons for my conclusion in this letter. I am going to specifically discuss his risk of an important, now well-recognized, adverse event: vaccine myocarditis.

What follows is some important background information about vaccine myocarditis that has been gleaned over the last 2 years before I discuss the particulars of Mr. Smith’s case.

It is relevant to note here that as a physician active clinically in both the inpatient and outpatient arenas, I am an eyewitness to the severe toll COVID-19 took on my patients in the Spring or 2020. I was impressed enough with the initial mRNA vaccine data to acquire the vaccine available from the Philadelphia Department of Health (Moderna) and ran multiple vaccine clinics in order to vaccinate my mostly high-risk patients.

What follows is data produced since the vaccine rollout that is relevant to Mr. Smith’s case.

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COVID-19 myocarditis illusions: A new cardiac MRI study raises questions about the diagnosis

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BY ANISH KOKA

One of the hallmarks of the last two years has been the distance that frequently exists between published research and reality. I’m a cardiologist, and the first disconnect that became glaringly obvious very quickly was the impact COVID was having on the heart. As I walked through COVID rooms in the Spring of 2020 trying to hold my breath, I waited for a COVID cardiac tsunami. After all social media had been full of videos from Wuhan and Iran of people suddenly dropping in the streets. My hyperventilating colleagues made me hyperventilate. Could it be that Sars-COV2 had some predilection for heart damage?

Happily, I was destined for disappointment. There never was a cardiac tsunami from COVID.

There were, unhappily, lots of severely ill patients with lungs that were whited out who quickly developed multi-organ dysfunction while hospitalized. The lungs were where almost all the action was. Every other organ got hit hard because of the systemic illness that unfortunately often is a downstream result of a severe respiratory illness. Cardiac Cath labs waiting for some major influx of COVID heart damage not only didn’t see patients presenting with COVID heart attacks, but they idled as patients terrified of coming to the hospital stayed home rather than come to the hospital with chest pain. (Public health messaging about COVID appears to have kept people away from hospitals, and autopsy series of deaths during the pandemic found that reduced access to health care systems (for conditions such as myocardial infarction) was further likely to be identified as a contributory factor to death than undiagnosed COVID-19).

So imagine my surprise when I saw peer-reviewed research based on a cardiac MRI study come out in 2020 suggesting that 78% of patients who survived COVID may have significant heart damage. A more detailed read of the paper, of course, threw up massive problems. The article and authors were more suited as writers for Oprah and Dr. Phil than for a well-respected academic journal. But the damage was done, and the notion that COVID was attacking hearts spread via a social media influencer class that should have had the credentials and smarts to know better, but clearly didn’t.

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

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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The college football fans that beat COVID and the experts that couldn’t

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BY ANISH KOKA

The COVID pandemic was supposed to herald the end of the idea that a smaller government is a better government. The experts who desperately seek to be in charge of a sprawling bureaucratic state told us that it was only a powerful central authority that could do what was needed to safeguard individual liberties at a time when a highly contagious respiratory virus was spreading across the globe.

New Zealand may have imposed draconian policies that did not even allow its own citizens to return, but scenes of cheering unmasked New Zealanders stood in sharp contrast to empty seats in American stadiums when teams were allowed to play. If only US politicians possessed the iron will of New Zealand premier Jacinda Arden, Americans too could have ‘freedom’.

But in so many ways, the New Zealand example demonstrates the utter foolishness and shortsightedness of the central planners that seized control globally. A year after New Zealand took their victory lap COVID arrived in New Zealand and a very much masked Prime Minister noted that “very soon we will all know people who have Covid-19 or we will potentially get it ourselves”

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Long COVID cardiac studies: More questions than answers.

BY ANISH KOKA

The NIH recently announced $1.2 billion dollars in funding for research on Long COVID. This is in part because of a faction of scientists that have mined electronic health record databases to find evidence that the long term impacts of COVID on a variety of different organ systems is significant.

I have some concerns when it comes to the cardiac complications discussed related to Long COVID.

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The Impact of COVID-19 on Shared Priorities for International Cooperation in Active and Healthy Aging

By ELIZABETH BROWN, CATALYST @ HEALTH 2.0

IN THIS MINI-SERIES, WE WILL BE TAKING A LOOK BACK AT THE IDIH WEEK 2022 USA REGIONAL WORKSHOP, TITLED THE IMPACT OF COVID-19 ON THE SHARED PRIORITIES FOR INTERNATIONAL COOPERATION IN ACTIVE AND HEALTHY AGING, WITH A DIFFERENT BLOG POST DEVOTED TO EACH OF THE THREE COMMON PRIORITIES THAT WERE REFINED THROUGHOUT THE IDIH PROJECT: INTEROPERABILITY BY DESIGN, DATA GOVERNANCE, AND DIGITAL INCLUSION.

INTRODUCTION: THE REGIONAL WORKSHOP PANELISTS AND BACKGROUND OF THE PANEL

For the past three years, Catalyst has been involved in the IDIH Project, which has recently concluded (you can read more about the overall project findings here). IDIH (International Digital Health Cooperation for Preventive, Integrated, Independent and Inclusive Living) – funded under the European Union Horizon 2020 Research and Innovation Program – was aimed at fostering cooperation in the field of Digital Health for Active and Healthy Aging (AHA) between the European Union and five Strategic Partner Countries (Canada, China, Japan, South Korea, and USA), especially focusing on four key areas that embrace common priorities of all countries/regions involved: Preventive Care, Integrated Care, Inclusive Living, and Independent and Connected Living. 

Following an expert-driven approach, experienced and renowned experts, executives, and advocacy groups from the six regions (Europe, China, Canada, Japan, South Korea and USA) were brought together by IDIH in a Digital Health Transformation Forum working to define more specific priorities in Digital Health and Ageing, and identifying opportunities for mutual benefit and priorities for international cooperation.  

During IDIH Week 2022, Catalyst ran a Regional Workshop aiming to explore the impacts of COVID-19 on AHA.

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Dr. Topol’s comment on LongCOVID and the heart is misleading/lacking context

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By ANISH KOKA

It’s been a while but Anish Koka, a one time regular writer on THCB and occasional THCB Gang member, is back publishing up a storm on his Substack channel. You may recall that his political and clinical views don’t always mesh with some of the wooly liberals we feature on THCB (cough, cough, me), but we are delighted to be back publishing some of his pieces–starting with a look at a tweet from one of America’s most prominent cardiologists.–Matthew Holt

Given Twitter’s commitment to the truth in Medicine, I thought I would try to give them a hand by analyzing a semi-viral tweet about COVID and the heart.

Earlier this year (April 2022), the most influential cardiologist in the world tweeted about a study on the long term cardiac effects of COVID (LongCOVID).

Medical trainees who trained in the early 2000s like I did know Dr. Topol as an absolute legend in the field of Cardiology. He was responsible for seminal work in Cardiology in the 1980’s on the use of clot busting drugs for patients having heart attacks, and became head of cardiology for the famed Cleveland Clinic at the age of 36! (I vaguely recall feeling like I was starting to understand Cardiology at the age of 36.) He’s since moved on to do many other things, and is a potent voice that may have been instrumental in the FDA delaying approval of the mrna vaccines until after the 2020 election.

Nonetheless, this paper that he is giving his significant stamp of approval to has significant issues. As far as I can tell individuals with LongCOVID were recruited by advertising in LongCOVID support groups. No independent assessment carried out as far as I can tell clinically. If you say you have it—> you’re in.

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Matthew’s health care tidbits: Is Covid over for the health care system?

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

I am beginning to wonder, is COVID over? Of course no one has told the virus that it’s over. In fact infection rates are two to three times where they were in the post-omicron lull and new variants are churning themselves out faster and faster. We still have 300 people dying every day. But since we went past a million US deaths, no one seems to care any more.

For the health care system, COVID being over means a chance to get back to normal, and normal ain’t good. Normal means trying to get rid of that pesky telemedicine and anything else that came around since March 2020.The incumbents want to remove the public health emergency that allowed telemedicine to be paid for by Medicare, re-enforce the Ryan Haight act which mandates in-person visits for prescribing controlled Rx like Adderall for ADHD, and make sure that tortuous state license requirements for online physicians are not going away. This also means restrictions on hospital at home, and basically delays any other innovative way to change care delivery. Well, it was all so perfect in February 2020!

But there is one COVID related problem that doesn’t seem to be going away. People. They’re just not going back to work and nurses in particular are resisting the pull of the big hospitals. I don’t know the end game here, but there is a clue in the “return to office” data. Basically every large city is below 50% of its office space being occupied and companies are having to figure out a hybrid model going forward, no matter how much Elon Musk objects.

Hospitals aren’t going willingly into the night. The big systems still control American health care, and are prepared to fight on all fronts to keep it that way. But like office workers, nurses and doctors want a different life. The concept of virtual-first, community-based, primary care-led health care has been around for a long while and been studiously ignored by the majority of the system.

If hospitals can’t get the staff and keep losing money employing the ones they have, there will be new solutions being offered to clinicians wanting a different life-style. We just might see a different approach to health care delivery rising phoenix-like from the Covid ashes.

The Reckoning: What Happens to Digital Health After COVID?

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By JEFF GOLDSMITH and ERIC LARSEN

It has been a rough year so far for digital health. After an astonishing $45 billion poured into new digital health companies in 2020 and 2021, and an early 2021 peak in market valuations of publicly-traded digital health providers, valuations and multiples have collapsed. Once high-flying Teladoc, which traded at an eye-watering 42x revenues and commanded a $45 billion market capitalization, is now trading around 2.7X at about $5.7 billion. AmWell, the next largest telehealth player, has seen its stock drop more 90% from its high.

Nor is the evaporation in market value is confined to just a few highly visible incumbents. The 29 healthtech companies to go public (either via IPO or SPAC) in 2021 were collectively trading 45% lower than their opening day price by the end of the year, according to STAT. Among the privately held firms, re-valuation of digital health is getting underway. Bearish market signals portend a sharp correction in digital health, characterized by brutal price competition, widening (and less tolerated) operating losses, layoffs, and ultimately, widespread consolidation. 

However, there is also major pushback from the ‘demand side’ of the digital health equation. With the explosion of digital health players, potential customers are confused and frustrated. There is a fundamental disconnect between the exuberant (and as yet largely unsubstantiated) promises of digital health startups and the needs of the four ‘phenotypes’ of health care customers. How digital health firms respond to those customers’ needs will ultimately determine the shape and size of the digital health market.

Why is the Digital Health Market Correcting?

Let’s start with the supply side. It is not difficult to identify the source of the digital health boom: hyper liquidity in the market fueled by expansive COVID-related fiscal and monetary policy. In the heat of COVID, Congress enacted three enormous stimulus/relief packages in eighteen months. The Federal Reserve also turned deeply dovish, keeping interest rates near zero and embracing epic quantitative easing – pumping $120 billion a month into the economy and expanding its balance sheet by more than $6 trillion. Much of this newly printed cash found its way into the coffers of private investors. Private equity, growth equity, and venture capital collectively raised $733 billion in new capital across 2021.  Globally, private equity firms alone invested $151 billion in healthcare in 2021.

Telehealth Ignition

The spark to ignite the digital health explosion came from the surprise growth in telehealth visits in the spring of 2020. In the wake of the spring 2020 lockdown and freeze on elective hospital care that accompanied the COVID public health emergency, telehealth visits went from less than 1% of total Medicare Part B patient visits in 2019 to nearly 13% during the spring of 2020 (and nearly 38% of all behavioral health visits), according to an analysis by DHHS’s ASPE. Private insurers saw 50-70% of behavioral health visits turn virtual.

This surge was not caused by a spontaneous surge of consumer activism but rather by hospital systems desperate to remain in touch with existing patients during the spring COVID lockdown. These systems saw plummeting visit volumes not only due to service closures but to patient reluctance to visit hospital ERs and outpatient clinics crowded with contagious COVID patients. Larger systems with extensive IT infrastructure were able to stand up far more robust telehealth offerings than smaller systems. As Bob Wachter, Chair of Medicine at University of California at San Francisco said, “We made 20 years’ worth of progress in twenty days.”

The sudden multi-thousand percent rise in telehealth volumes led to breathless estimates of future growth in telehealth volumes and revenues. In July 2020, McKinsey estimated a total addressable market (TAM) of $250 billion for telehealth services — this from a business with a revenue base McKinsey itself estimated at $3 billion in 2019-2020, and $5.5 billion in 2020-2021. This risible TAM estimate assumed that 24% of all physician and outpatient visits (a 1.8 billion visit “universe”) and 25% of Emergency Department visits would be addressed through telehealth alternatives.

However, more than 90% of telehealth visits during the spring of 2020 were with physicians patients already knew, not random, anonymous physicians signed on to cover telehealth services by vendors. And 47% of those visits were one-time users, according to a recent Trilliant analysis. Visit volume growth was also materially aided by Congressional approval of temporary Medicare coverage for telehealth visits as part of the COVID Public Health Emergency declaration. 

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