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Tag: Anish Koka

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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Myocarditis update from Sweden

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BY ANISH KOKA

The COVID19/vaccine myocarditis debate continues in large part because our public health institutions are grossly mischaracterizing the risks and benefits of vaccines to young people.

A snapshot of what the establishment says as it relates to the particular area of concern: college vaccine mandates:

Dr. Arthur Reingold, an epidemiology professor at UC-Berkeley, notes that UC also requires immunizations for measles and chickenpox, and people still are dying from COVID at rates that exceed those for influenza. As of Feb. 1, there were more than 400 COVID deaths a day across the U.S.

“The argument in favor of mandatory vaccination for COVID is no different than the argument for mandatory vaccination for flu, measles and meningitis,” Reingold said. “For a 20-year-old college student, how likely are they to die? The risk is very low. But it’s not zero. The vaccines are safe, so the argument of continuing to mandate vaccination fits very well with the argument for the other vaccines we continue to require.”

Safety is a relative term that needs to be constantly updated when you’re talking about administering a therapeutic to “not-yet-sick” individuals. We do not vaccinate against smallpox anymore because the absence of circulating smallpox (thanks to the smallpox vaccine campaign) makes the risks of the smallpoxt vaccine too great to be administered to the public.

We can argue endlessly about what exactly the risk of COVID19 was in the Spring of 2020, or 2021, but there should be little argument in 2023 that the risks of COVID pneumonia striking down a young healthy individual is now extremely low.

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A COVID-19 vaccine exemption letter

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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 ?

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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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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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America, the intolerant

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BY ANISH KOKA

Historically, the great tension between liberty and authority was between government as embodied by the ruling class and its subjects.  Marauding barbarians and warring city-states meant that society endowed a particular class within society with great powers to protect the weaker members of society.  It was quickly recognized that the ruling class could use these powers for its own benefit on the very people it was meant to protect, and so society moved to preserve individual liberties first by recognizing certain rights that rulers dare not breach lest they risk rebellion.  The natural next step was the establishment of a body of some sort that was meant to represent the interests of the ruled, which rulers sought agreement and counsel from, and became the precursor to the modern day English parliament and the American Congress.  Of course, progress in governance did not end with rulers imbued with a divine right to rule being held in check by third parties.  The right to rule eventually ceased to be a divine right, and instead came courtesy of a periodical choice of the ruled in the form of elections.  The power the ruled now wielded over those who would seek to rule lead some to wonder whether there was any reason left to limit the power of a government that was now an embodiment of the will of the people.

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Why mandating boosters for college kids is a no good, very bad, dumb idea

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By ANISH KOKA and VIRAL MYALGIA

A number of colleges have mandated boosters for students returning to campus this fall. There are some points parents, teenagers, and whoever is coming up with policies at colleges may want to consider. Since no one has thought fit to actually generate any clinical data on boosters in college kids because of the continuous state of COVID emergency we have been in since early 2020, we are left to try to extrapolate from a vast amount of ecological data and surrogate endpoints.

While it would be impossible to include every single study ever done on the matter, there is clearly enough data to argue against their being the overwhelming scientific consensus that would be needed to underpin a policy that essentially forces individuals to receive a medical therapeutic.

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Vaccine Myocarditis Update

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BY ANISH KOKA

The European Medicines Agency decided on July 19, 2021 that myocarditis and pericarditis be added to the list of adverse effects of both messenger RNA (mRNA) based vaccines (BNT162b2 [Pfizer-BioNTech] and mrna-1273 [Moderna]) against COVID-19. This advice was based on numerous reports of myocarditis that followed a clinical pattern that strongly suggested a causal link between these particular vaccines and myocarditis/pericarditis. The adverse events that appeared to be predominantly in young men typically occurred within a week after injection, and were clustered after the second dose of the vaccine series. A recent national database from France sheds some light on the approximate rates of mrna vaccine related myocarditis.

Between May 12, 2021 and October 31, 2021 within a population of 32 million persons aged 12-50 years, 21 million first doses of the BNT162b2 (Pfizer) vaccine and 2.86 million first doses of the mrna-1273 (Moderna) vaccine. In the same period, 1612 cases of myocarditis and 1613 cases of pericarditis with myocarditis were recorded in France. Compared to matched control subjects, the risk of myocarditis was markedly increased after 1st and 2nd doses of the vaccine. For the Pfizer vaccine, the odds of myocarditis were 1.8 times the expected background rate for the 1st dose and 8 times the expected background rate for the 2nd dose. The Moderna vaccine, which delivers about three times the dose of the Pfizer vaccine has an even higher risk of myocarditis — a stunning 30 times the expected background rate after the second dose. A prior history of myocarditis was associated with an odds-ratio of 160.

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US Cardiac electrophysiologists meet reimbursement reality and don’t like it.

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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–this one is on reimbursement.–Matthew Holt

The subspecialty of Cardiology known as electrophysiology has seen explosive growth over the last few decades in large part because of a massive expansion in the suite of procedures now offered to patients. It used to be that electrophysiologists would spend the majority of their careers implanting pacemakers and defibrillators, but the last 2 decades saw an explosion in electrophysiology procedures known as ablations. Ablations essentially involve burning cardiac tissue in a strategic manner to get rid of arrhythmias that may be afflicting a particular patient. The path humans took from first taking an electrical picture of the heart with a surface ECG to putting catheters into the heart to map and treat dangerous arrhythmias is one of the great achievements of the modern era.

Giants of the field like the recently deceased Mark Josephson essentially created a field by going where no humans had gone before. Dr. Josephson did much of his work in Philadelphia at the University of Pennsylvania publishing seminal papers that lead to a greater understanding and eventual treatment of previously incurable malignant arrhythmias. As is true of all trailblazing work in medicine , there were no reimbursement codes in the beginning , just desperate patients with no place to turn.

The procedures being embarked on were rare and the patients were very complex. The renumeration that was awarded from Medicare was reflective of this. But two things almost always happen once a highly reimbursed procedure code comes on line – technological advances makes the procedure easier, and the population that the procedure is intended for massively balloons.

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