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.
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.
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.
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.
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.
THCB Gang is back from its summer break. Joining me Matthew Holt (@boltyboy) for an hour of topical and sometime combative conversation on what’s happening in health care and beyond will be patient safety expert and all around wit Michael Millenson (@MLMillenson); fierce patient activist Casey Quinlan (@MightyCasey), medical historian Mike Magee (@drmikemagee), WTF Health host & Health IT girl Jessica DaMassa (@jessdamassa); and making a rare but welcome appearance cardiologist & provocateur Anish Koka (@anish_koka). Watch it live below.
If you’d rather listen than watch, the audio is preserved as a weekly podcast available on our iTunes & Spotify channels
Joining me , Matthew Holt (@boltyboy), on THCB Gang this week were fierce patient activist Casey Quinlan (@MightyCasey), consumer advocate & CTO of Carium, Lygeia Ricciardi (@Lygeia), THCB regular authors radiologist Saurabh Jha (@roguerad) & cardiologist Anish Koka (@anish_koka), with futurist Jeff Goldsmith on hand to keep us all honest. We started with Casey’s current health journey and Anish’s inability to get vaccines for his clinic — and this moved to a really fun and raucous discussion about whether the public sector can work in health care, whether we need to mandate the vaccine and if America is becoming a failed state! Great stuff!
If you’d rather listen than watch, the audio is preserved as a weekly podcast available on our iTunes & Spotify channels
“The patient in room 1 should be a quick one, its an addon, they just need a prescription for ivermectin”
I’m a bit puzzled by this sentence from my assistant doing his best to help me through a very busy day in the clinic that I’m already behind in. I walk into the room, a script pad stuffed into my hand as I enter the room, to meet a very nice couple. The wife sits patiently with hands crossed on the exam table.
“So, you’re here for Ivermectin?”, I ask.
Why yes, a trip to Texas is planned.. COVID is in the air, the internet, and some important people who have ‘inside knowledge’ have raised doubts about the vaccine. Some other people who quite possibly could be the same people, have also suggested prophylactic ivermectin is the better bet to prevent these good people from catching COVID.
Ivermectin is a drug known to work against parasites. The virus angle relates to in vitro data that suggests Ivermectin inhibits the host importin alpha/beta-1 nuclear transport proteins, which are part of a key intracellular transport process that viruses use to enhance infection by suppressing the host’s antiviral response. In addition, ivermectin may interfere with the attachment of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein to the human cell membrane. Ivermectin demonstrates a broad spectrum of activity in-vitro against a variety of viruses like dengue, Zika, HIV, and yellow fever. Unfortunately, despite this in vitro activity, no clinical trials have reported a clinical benefit for ivermectin in patients with these viruses.
Ivermectin does inhibit Sars-Cov2 viral replication in cell cultures. However, pharmacokinetic studies suggest that achieving the plasma concentrations necessary for the antiviral efficacy detected in vitro would require administration of doses up to 100-fold higher than those approved for use in humans. Even though ivermectin appears to accumulate in the lung tissue, predicted systemic plasma and lung tissue concentrations are much lower than 2 µM, the half-maximal inhibitory concentration (IC50) against SARS-CoV-2 in vitro. Subcutaneous administration of ivermectin 400 µg/kg had no effect on SARS-CoV-2 viral loads in hamsters, though there was a reduction in olfactory deficit and a reduction in the interleukin (IL-6:IL-10) ratio in lung tissues.
Since the pandemic began, there have been a number of small randomized controlled trials of ivermectin in mild COVID patients that show more rapid viral clearance, but not too much else. The prophylaxis data is considerably more sparse, and is of the retrospective variety. Basically take a number of countries that use Ivermectin variably and compare the incidence of COVID in those countries.
A recent email that arrived in my in-box a few weeks ago from an academic hailed the latest “paradigm shift” in cardiology as it relates to the management of stable angina. (Stable angina refers to chronic,non-accelerating chest pain with a moderate level of exertion). The points made in the email were as follows (the order of the points made are preserved):
The financial burden of stress testing was significant (11 billion dollars per annum in the USA!)
For stable CAD, medical treatment is critical. We now have better medical treatments than all prior trials including ischemia. these include PCKS9 Inhibitor, SGLT2-i, GLP1 agonists Vascepa and others
CTA coronaries is by far the most important single test for evaluation of these patients
” the paradigm of ischemia testing may have come to an end”
For stable angina (not ACS!) in most cases, the decision on revascularization should be based only on symptoms alleviation (as no survival benefit).
The general public should find it interesting, and not a random coincidence that the first point immediately gets to the financial burden of stress testing in a communication that is supposed to assess the level of evidence for the management of coronary artery disease. Imagine a cardiologist enters your exam room to talk about the chest pain you get every time you run up a flight of steps, and starts off the conversation with how much the societal cost of stress tests are. The cost of care is certainly a relevant concern, especially if it’s to be borne directly by the patient, but it would seem that the decision of whether a therapy is effective or not should be divorced from how much some bean counter decides to price the therapy to generate a certain return on investment. As such, the discussion that follows will omit any consideration of cost when evaluating the new ‘paradigm shift’ in management of coronary disease that is apparently upon us.
This particular debate boils down to the relevance of diagnostic testing for coronary artery disease. The traditional approach to testing is a functional test that utilizes the uptake of radioactive isotope injected into a patient during stress and rest conditions to identify mismatches in blood flow in the two states to identify myocardial ischemia. The amount of ischemia can be quantified as percent of total myocardium, and has been well correlated with prognosis. Having lots of ischemia typically means a much shorter lifeline than having little or no ischemia. The accepted paradigm in Cardiology has been to use traditional stress testing to triage patients to ‘conservative’ medical therapy or an invasive approach to bypass or open arteries via stents or coronary bypass surgery.
The most recent fiction dressed up as science about COVID comes to us courtesy of a viral Washington Post article. “How the Sturgis Motorcycle Rally may have spread coronavirus across the Upper Midwest” screams the headline. The charge made is that “within weeks” of the gathering that drew nearly half a million visitors the Dakota’s and adjacent states are experiencing a surge of COVID cases.
The Sturgis Rally happens to be a popular motorcycle rally held in Sturgis, South Dakota every August that created much consternation this year because it wasn’t cancelled even as the country was in the throes of a pandemic. While some of the week long event is held outdoors, attendees filled bars and tattoo parlors,(and that too without masks!), much to the shock and chagrin of the virtuous members of society successfully able to navigate life via zoom, amazon prime, and ubereats.
This particular Washington Post article’s sole source of data comes from a non-profit tech organization called The Center For New Data that attempted to use cellphone data to attempt to track spread of the virus from the Sturgis rally. Unfortunately, tracking viral spread using cellphone mobility data is about as hard as it seems. The post article references only 11,000 people that were able to be tracked out of a total of almost 500,000 visitors, and isn’t able to assess mask wearing, or attempts at social distancing. How many bars are there to stuff into in Sturgis anyway?? And so it isn’t surprising that even in an article designed to please a certain politic, this particular sentence appears:
“But precisely how that outbreak unfolded remains shrouded in uncertainty.”