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15/09/2022
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15/09/2022
Help us achieve our goal of bringing better oral health to all All year long we appeal for a wide range of causes which are very close to our hearts. All of these are with the singular aim of bringing better oral health to those most in need. Whether it’s giving every child the necessary tools and education they need to have good oral health for life, helping to reduce mouth cancer rates and even offer those most in need the oral health support they desperately need our appeals have been designed to meet specific requirements not only in the UK but around the world. By donating to a specific appeal your contribution will be ring-fenced to ensure it achieves exactly what you want it to. See why your donations are needed and what they can help to achieve. Mouth Cancer Action Appeal Mouth cancer rates have increased by more than a third in the last decade and are predicted to continue increasing for years to come, but awareness of this deadly disease remains dangerously lo...
Appeals | Oral Health Foundation Independent UK oral health charity.
15/09/2022
Joining Matthew Holt () on on Thursday September 15 patient safety expert and all around wit Michael Millenson (); Suntra Modern Recovery CEO JL Neptune (); fierce patient activist Casey Quinlan (); delivery & platforms expert Vince Kuraitis (); & policy expert consultant/author Rosemarie Day ();
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.
THCB Gang Episode 104, Thursday September 15 at 1pm PT, 4pm ET Joining Matthew Holt () on on Thursday September 15 patient safety expert and all around wit Michael Millenson (); Suntra Modern Recovery CEO JL Neptune (); fierce patient activist Casey Quinlan (); delivery & platforms expert Vince Kuraitis....
13/09/2022
BY KIM BELLARD
Well, as usual, there’s a lot going on in healthcare. There’s the (potential) Amazon – One Medical acquisition, the CVS – Signify Health deal, and the Walmart – United Healthcare Medicare Advantage collaboration. Alphabet’s just raised $1b. Digital health funding may be in somewhat of a slump, but that’s only compared to 2021’s crazy numbers. Yep, if you’re a believer that a revolution in healthcare is right around the corner, there’s a lot of encouraging signs.
But I was in a Walmart the other day, and my thought was, these people don’t look like they care much about a revolution in healthcare. In fact, they don’t look like they much care about health generally. That’s not a knock on Walmart or Walmart shoppers, that’s an assessment about Americans’ appetite for changes in our health care.
That’s not to say we like our healthcare system. A new AP-NORC survey found that 56% felt that the US did not handle healthcare well (curiously, 12% thought we handled it extremely/very well – huh?). Prescription drugs, nursing homes, and mental health rated especially low. We’d like the government to do more, but not, it would seem, if it means we pay higher taxes.
Much of what is wrong is our own fault. We know that we eat too many processed foods, that the food industry scientifically preys on us to target our weaknesses for fat, sugar, and salt, that we’d rather sit than drive and drive than walk, and that we are poisoning our environment, and, in turn, ourselves. Given a choice between short term benefits versus long term consequences, though, we’ll eat that Oreo every time, literally and metaphorically.
What started me down this grim train of thought, oddly enough, is a new article in The Atlantic by Jennifer A. Doudna: “Starting a Revolution Is Not Enough.” Dr. Doudna’s focus was, naturally, on the CRISPR revolution, but some of her points apply more broadly.
Dr. Doudna is justifiably proud of all that CRISP has already accomplished, but:
I also feel a continual sense of urgency: Are we dreaming big enough? Moving quickly enough? I think back to the advent of the cellphone—another groundbreaking technology in our shared memory. For those of us lucky enough to have experienced it, the untethering of communication from a landline was a seminal moment. But who could have predicted that this once niche and luxury technology would become so ubiquitous as to outnumber the human population, creating new economies and changing the way we live?
That’s my fear about all of the supposed revolutions in healthcare: I’m pretty sure we’re not dreaming big enough, and we definitely aren’t moving quickly enough.
With CRISPR, Dr. Doudna believes:
Ensuring that CRISPR reaches its full potential for clinical applications and beyond will require an even higher level of intentional building with diverse and dedicated collaborators. Governments, universities, and investors will need to make significant and sustained investment in cutting-edge science at labs and at biotechnology companies, as well as investments in infrastructure and manufacturing to ensure that this work is scalable.
All that could also be talking about AI, nanotechnology, robotics, VR, or any of the other long list of innovations that have the potential to revolutionize healthcare. We’re a long way from finishing the science, much less bringing it to play into our healthcare system and, more importantly, into our everyday lives.
Technology is not enough. In a New York Times op-ed about the Amazon-One Medical acquisition, Libby Watson asserts:
Any company claiming its innovation will revolutionize American health care by itself is selling a fantasy. There is no technological miracle waiting around the corner that will solve problems caused by decades of neglectful policy decisions and rampant fraud.
Similarly, Dr. Doudna worries about potential abuse with CRISPR: “How do we ensure that those in need have access when people or companies with money and power cut in line?” That is, unfortunately, how our healthcare system has worked in recent decades, and perhaps always. They will not accede to change easily.
It’s worth remembering that most revolutions fail. They start too soon, they don’t have enough popular support, they face vested interests that are too firmly entrenched, or their timing is simply off. Americans are proud of our own revolution, but too often we forget that most of the colonists did not support it, that we needed strong allies, that a few key leaders were pivotal, and that it took both some luck and some blunders from our opponents to ultimately succeed.
In healthcare, we have to remember that, while a majority of us aren’t happy with our healthcare system, only a minority of us are pushing for big changes. Only a minority of us are actively engaged in our health on a daily basis. We say we’re unhappy about costs but what we really mean is that we want someone else to pay the costs. We grumble about how expensive they are but don’t really want our doctors or local hospitals to take revenue hits. We hate pharma and health insurance companies, but only until we need them.
The vested interests in our healthcare system aren’t you and me; they’re the people who are first in line for care and for whom money is never any issue. They’re the medical/industrial complex, including those local doctors and hospitals, who profit from the existing system. We’re not going to have a revolution without them being disrupted, and few of us are quite ready for that.
A revolution in healthcare isn’t our existing system but with some newer technologies; we’ve been incrementally doing that for a long time. A revolution in healthcare would actually look different, would deliver care differently, would impact our health differently, and hopefully would be financed differently.
As Dr. Doudna says, in reference to CRISPR but with application to other revolutionary technologies: “When facing progress of this magnitude, the first step toward adoption must be societal buy-in.” No, we’re not quite there yet. Worse yet, I’m not quite sure what will get us there.
There’s a famous quote – variously attributed to Albie Sachs, Bill Ayers, and Leon Trotsky – to the effect: “All revolutions are impossible until they happen. Then they become inevitable.” I still believe that a revolution in healthcare is inevitable, but have to admit that we’re still in the stage when it seems impossible.
Kim is a former emarketing exec at a major Blues plan, editor of the late & lamented Tincture.io, and now regular THCB contributor.
Start the Revolution without Us BY KIM BELLARD Well, as usual, there’s a lot going on in healthcare. There’s the (potential) Amazon – One Medical acquisition, the CVS – Signify Health deal, and the Walmart – United Healthcare Medicare Advantage collaboration. Alphabet’s just raised $1b. Digital health funding may be in...
12/09/2022
BY JESSICA DaMASSA
Early-stage health tech start-up Caridokol is developing technology that listens to the sound of a patient’s voice over a mobile phone, landline phone or smart speaker to detect and analyze vocal biomarkers that indicate that the patient may be suffering from disease. The voice tech co is proving its case first in detecting arrhythmias, which are often asymptomatic and usually go undetected until they’ve led to a more serious issue like a stroke.
Cardiokol’s CEO James Amihood explains the tech behind this first use case – which already has one US patent granted and is pending approval on three more – and his plans to expand the company’s base of vocal biomarkers to enter into new disease states and new markets. The company is currently raising a Series A funding round and is planning to expand from Israel and Europe to the US. How could the technology change the game for disease prevention, starting with strokes? James connects the dots to the big vision for the company’s future as he explains how Cardiokol’s tech is already providing those most at-risk of arrythmia a very cost-effective, simple-to-use way to screen and monitor their long-term heart health.
Meet Voice Tech Start-Up Cardiokol BY JESSICA DaMASSA Early-stage health tech start-up Caridokol is developing technology that listens to the sound of a patient’s voice over a mobile phone, landline phone or smart speaker to detect and analyze vocal biomarkers that indicate that the patient may be suffering from disease. The voice ...
12/09/2022
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
Meanwhile, it’s time for Matthew’s tidbits. A quick moment’s thought of course for the Queen, her family and semi-loyal subjects, of which I am (sort of) one. In fact in the last 7 days my ancestral homeland of the UK has got a new King, a new prime minister and a new manager at Chelsea FC. Still, two of three of those changes seem to happen about every 18 months so we shouldn’t be too surprised that they all happened at once.
Talking of changes, this week’s big American health care news was the other Matthew Holt pocketing a boatload of cash. Yes, Jess DaMassa is still hoping to upgrade her partner on Health Tech Deals without having to change the name on the intro (and ain’t shy about telling me!). The wrong Matthew Holt (from my bank balance’s perspective) has a fund called New Mountain Capital, which owns a lot of health tech assets. It was the majority owner of Signify Health–bought this week for $8bn by CVS, after being the subject of a bidding war between them, United & Amazon.
Signify is very interesting for what it does or doesn’t do. Almost all its business (having acquired and recently shut down a bundled care payments division) is now connected to sending nurses out to the homes of Medicare Advantage (MA) members on behalf of all the big payers (Aetna, United, Humana, etc) to do in-home health assessments of their members. Critics say that these assessments were used to upcode the health risk assessment factor (RAF) of those members, which causes CMS to pay more to those MA plans. MA’s defenders, including George Halvorson on THCB, say that this upcoding isn’t happening, or at least not in that way, and that the better care MA members get actually reduces overall Medicare costs.
Having read a lot and been talked at by both sides of this debate, it seems to me that both things are true. Many MA members have been “upcoded”, in many cases perhaps legitimately, and the CMS data–which is extremely murky & hard to parse–also seems to indicate that MA members’ treatment overall costs less than those in FFS. (I’ll spare you the CMS Trustees report but here is Milliman’s assessment–albeit paid for by MA proponents–using their data. MedPAC disagrees).
Signify brought in over $640m in revenue for those home evaluations in 2021 and is forecasting over $1bn in revenue this year at a healthy EBITDA. But that still means CVS is paying 8 times future revenue & maybe 30-40 times earnings. It will indeed be interesting to see if health plans remain so keen on these home evaluations if (as George Halvorson says) CMS has actually stomped on them being used for RAF upcoding. It’s also not clear if those MA plans competing with CVS/Aetna will be keen on using a company owned by one of their rivals–which might put its thumb on the scale in ways they can’t know about.
Of course, it might just be that what Signify is doing is radically improving the experience and health of those seniors in Medicare Advantage by discovering what health and social issues they have, and helping their plans and providers manage their care better. Wouldn’t it be great if all seniors could get this type of care and attention? And wouldn’t it be great if the taxpayer knew it was both helping improve seniors’ health and reducing our costs? The challenge for Medicare (and the rest of us) is to get to a place where the incentives are transparently only for improving health, and where Medicare Advantage plans are regarded across the board as actually doing only that.
We are not there yet.
What does CVS’s new deal signify about Medicare Advantage? 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 Meanwhile, it's time for Matthew's t...
12/09/2022
This Turkey and white bean chili is a really one of those soups that is packed with a ton of flavor. It's healthy and really simple to make. The best part is it can be make with Turkey or Chicken. You can use leftover turkey or chicken or slice a turkey/chicken breast in to small pieces then cook it with all the great spices. This white bean chili is made with easy to find ingredients like chicken or turkey, canned white beans, green chilies and chicken broth. It is a satisfying and very delicious that is ready in a few minutes and takes very little effort to make.
Types of Beans
The white beans that we like to use in this recipe are Navy Beans, White Kidney Beans also know as Cannelloni, Lima Beans or Great Northern Beans. All are great so use what you have in the pantry.
How to Make White Bean Chili with Turkey or Chicken
First Prep all the ingredients. This is a super easy quick recipe and is super easy if everything is ready. First measure the spices. Then chop the onion and garlic. If using raw chicken or turkey cut it into small bite size pieces. If using an already cooked chicken/turkey shred it is into small strips.
Chop the onions, garlic, and chicken/turkey. Heat olive oil in a sauce pan add the onions and garlic. Cook until the onions start to soften about 3 minutes. Add the chicken and start to cook add the spices. Cook over medium heat until the chicken is done. About 5 to 10 minutes. The spices will start to stick to the bottom and sides of the pan. Don't worry about the spices they will really add a ton of flavor when the chicken broth is added.
Bring the broth to a boil and simmer for 15 to 30 minutes. If using dry beans add them when the broth is added. If using caned beans wait until the broth has simmered for a while until the broth is really flavorful.
White Bean Chili - Dried Beans or Canned Beans
We made the white bean chili with dry beans but if you want a really quick chili make this with canned beans. If using dry beans place the beans in a large bowl and cover with water. Let them soak overnight. They will be soft but will need a little extra time to cook than canned beans. So we added the beans when the broth was added. They cooked and softened to the similar texture of canned beans.
Puree one can of the beans or two cups of beans. Add the beans and the pureed beans to the Chicken. Simmer for 10 minutes or so
Chop the Anaheim/ Hatch chilies or use already chopped green chilies. Remove from the heat and stir the chilies into the white bean chili.
NOTE: We actually roasted some Anaheim and Hatch chilies in the summer and freeze them so we have them to make dishes like this white bean chili. It's really easy to roast peppers and it is amazing how great the flavors are of these peppers.
Serve the white bean chili with cilantro, sour cream, green onions and even cheese. Play with your favorite toppings. This is always fun to have several choices for everyone to try something new. Hey, this white bean chili is good with no toppings.
We have also found its fun to have Frito's, Corn Chips or Doritos with this chili. And of course we had to add a Jalapeno for a little heat. So darn good!!!!
White Bean Chili with Chicken or Turkey
Chicken and White Bean Chili is packed full of flavor, low in calories and is so easy to make.
Print Pin
Course: Main Course, Main Dish
Cuisine: American
Keyword: Soup, White Bean Chili
Prep Time: 5 minutes
Cook Time: 10 minutes
Simmer Time: 1 hour
Total Time: 1 hour 15 minutes
Servings: 6 Servings
Calories: 370kcal
Author: Belly Laugh Living
A Few Things We Use
Stock Pot
Ingredients
1 Pound Turkey Breast Or Chicken Breast
3 Cans White Chili Beans, Cannellini Beans or Navy Beans We like a combination of the beans
1 Medium Onion
2 Cloves Garlic
1/2 Tablespoon Chicken Bouillon powder
1 teaspoon Ground Cumin
1/2 teaspoon Pepper
4 Ounces Green Chilies or use Fresh Anaheim/Hatch Peppers
32 ounces Chicken Broth
1/2 Cup Cilantro or Parsley
2 Green Onions
1/2 Tablespoon olive oil
1/2 Cup Sour Cream
Instructions
Prep Ingredients
Measure Spices (Cumin, Bouillon, White Pepper, )
Chop Onion
Chop Garlic
Cut Chicken Breast into bite size Piece
Chop Green Chili peppers
Thickener for Soup
Puree 1 can of Beans into Blender/food processor. Mix until smooth. If using Canned Beans. Take One Can of the beans and Puree in Blender.
Make the Chili
Place Olive Oil into Stock Pot. Add the Onions and Garlic. Cook until onions start to soften about 3 minutes
Add Chicken and Spices to the Onions. NOTE the spice will start to stick some don't worry when the chicken broth is added the will mix into the borth.
Cook Chicken until it turns white and is cooked through. About 5 minutes
Add The Chicken Broth to the chicken/onion mixture. Bring to Boil and cook for about 15 minutes to 1/2 hour.
Add the Can of beans and the Pureed Beans to the Chili. Cook for 10 minutes
Stir in the Chili peppers to the Chili
White Bean Chili with Turkey or Chicken This Turkey and white bean chili is a really one of those soups that is packed with a ton of flavor. It's healthy and really simple to make. The best part is it can be make with Turkey or Chicken. You can use leftover turkey or chicken or slice a turkey/chicken breast in to small...
08/09/2022
It’s been a week of endings for UK politicians, soccer coaches and tennis GOATs. And a big deal in health tech as CVS buys Signify Health for $8bn. Psych Hub raises $16m, 98point6 tacks on $20m more in a poss direction change & MedMinder tackles that hardest of all questions–Did I take my pill or not? Jess DaMassa almost lets me takeover, but we know who she really wants in charge! Matthew Holt
#HealthTechDeals Episode 45: CVS buys Signify; Psych Hub; 98point6 & MedMinder It's been a week of endings for UK politicians, soccer coaches and tennis GOATs. And a big deal in health tech as CVS buys Signify Health for $8bn. Psych Hub raises $16m, 98point6 tacks on $20m more in a poss direction change & MedMinder tackles that hardest of all questions--Did I take my pill or.....
08/09/2022
BY JESSICA DaMASSA
Headspace Health’s CEO Russell Glass and The Shine App’s co-Founder & co-CEO Naomi Hirabayashi give us the inside story on deal that makes The Shine App’s award-winning, inclusive self-care and mental health platform a part of the Headspace Health family.
This is Headspace Health’s second acquisition this year, and we find out why they chose to ‘buy instead of build’ when it came time to refine and enrich the inclusiveness of their meditation, self-care, and mental health care offerings.
The Shine App brings 45,000 subscribers and 90 enterprise clients to the table, but what Russ points to as ‘stand-out’ is the quality of the content that Shine is built on, and the depth of understanding that their team has realized when it comes to the unique mental health issues that are facing minorities and other traditionally underserved populations. For example? Naomi talks about “representation burnout” which is its own brand of burnout that is often-experienced-but-not-often-named by people who suffer the pressures of being the “lone representative” of a minority population in a vastly homogenous workforce. Wow.
Tune in for more on what this acquisition will mean for Headspace, what Naomi and her co-founder Marah Lidey intend to do as new Headspace employees, how Shine will help Headspace’s Leadership Training program, AND some extra surprise bonus gems. Apparently, the BIGGEST DEAL yet for the full integration of Headspace-plus-Ginger is on the horizon and, OF COURSE, I find out if Russ got a chance to meet John Legend as part of Headspace’s Super Bowl commercial shoot.
BREAKING: Headspace Health Acquires Shine App, A Diversity & Inclusion Self-Care Platform BY JESSICA DaMASSA Headspace Health’s CEO Russell Glass and The Shine App’s co-Founder & co-CEO Naomi Hirabayashi give us the inside story on deal that makes The Shine App’s award-winning, inclusive self-care and mental health platform a part of the Headspace Health family. This is Headspace H...
08/09/2022
BY MIKE MAGEE
Connecticut attorney general, William Tong, took a turn in the spotlight this week, representing 33 states and Puerto Rico in announcing that va**ng original, Juul, had agreed to pay penalties of $438.5 million to settle lawsuits against the company.
Juul in essence acknowledged that the company’s marketers had targeted young students, used social media to attract underage teens, and had given them free samples. With 45% of the company’s Twitter followers between ages 13 and 17, and an age verification methodology authorities label as “porous”, they were happy to get the nation’s attorney generals out of their hair.
Over the past four years, Juul has lost over 95% of its value. When Altria bought a 35% stake in the company in December, 2018, they paid $12.8 billion. That translates to just $450 million today. What were they thinking? At the time, Juul was fighting to preserve their “flavor pods” – with mango and creme brûlée a favorite among teens.
But the F.D.A. took a hard line, attempting to shut them down completely, attacking vaporized natural and synthetic ni****ne. Lobbyists for Altria and Juul argued that they had helped 2 million Americans quit traditional ci******es. That was enough to gain a “temporary reprieve”, sending the F.D.A. back to the drawing board for “additional review.”
By the way, local and state campaigns to curb teen va**ng seem to have had an effect. E-cigarette use in a survey in March, 2022, found 8% or some 2 million teens had used an e-cigarette in the past 30 days. As for traditional smokers, 31 million are still addicted to ci******es and 16 million currently have a smoking related chronic disease.
In the meantime, to***co giant, Philip Morris International, took a different tact. Last week they inked the purchase of Danish oral drug delivery company, Fermin Pharma, for $813 Million. They then “doubled-down” this week, announcing their intention to purchase “inhalation specialist” Vectura for $1.2 billion.
What are they up to? Their official site says this is all part of their “Beyond Nicotine” strategy, and will now be pursuing “respiratory drug delivery” and “selfceare wellness.” How much is that worth in future revenue. The company projects $1 billion in net revenues from these ventures by 2025. This is in part because Vectura has significant expertise with 13 inhalable products already on the market and $245 million in 2020 sales.
The concise market message reads:
“Philip Morris International (PMI) is leading a transformation in the to***co industry to create a smoke-free future and ultimately replace ci******es with smoke-free products to the benefit of adults who would otherwise continue to smoke, society, the company, its shareholders and its other stakeholders.”
And PMI says the future is bright: “The market for inhaled therapeutics is large and growing rapidly, with significant potential for expansion into new application areas. PMI has the commitment to science and the financial resources to empower Vectura’s skilled team to execute on an ambitious long-term vision. Together, PMI and Vectura can lead this global category, bringing benefits to patients, to consumers, to public health, and to society-at-large.”
What could possibly go wrong with that?
Mike Magee M.D. is a Medical Historian and author of “CODE BLUE: Inside the Medical Industrial Complex (Grove/2020).
“Beyond Nicotine”: To***co Joins Hands With Pharma. BY MIKE MAGEE Connecticut attorney general, William Tong, took a turn in the spotlight this week, representing 33 states and Puerto Rico in announcing that va**ng original, Juul, had agreed to pay penalties of $438.5 million to settle lawsuits against the company. Juul in essence acknowledged that t...
07/09/2022
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.
Odds ratios can be challenging to translate into a real sense of risk especially when dealing the a clinical diagnosis that is as rare as myocarditis is. A clinically busy cardiologist may see one case a year if they’re lucky, so a therapy that doubles the risk of myocarditis may seem a lot more scary than it actually is. In the case of this French database, a helpful supplemental table shows the risk of myocarditis is highest after a second dose of the Moderna vaccine in males aged 18-24 year old at a rate of 1/5900. The next most at risk group is 25-29 year old men with a rate of 1/9400.
Clearly, women have higher rates of myocarditis compared to background as well, but like most other databases to date, the rate of myocarditis is lower relative to men. The highest risk of myocarditis is in women aged 18-24 after the second dose of the Moderna vaccine at a rate of ~ 1/18,700.
The limitations to this study relate to how the diagnosis of myocarditis was made. Cases of myocarditis in this study were based solely on diagnosis codes associated with hospital admissions. This means the estimates here miss cases of myocarditis that never made it to the hospital, but also may overcount hospital admissions mislabeled as myocarditis.
Scientifically, there is no doubting the link between mrna vaccines and myocarditis. Even the CDC director that spent much of 2021 denying this possibility must now know this whether she is allowed to publicly say so or not. Even if one was to buy the party line that the mrna vaccines are beneficial in every age group for time immemorial, it would seem to be a matter of basic ethics to inform the public that one of the mrna vaccines (Moderna) has consistently been noted to have significantly higher rates of a serious adverse event in a particular demographic (young men). I would hope that, at least, most cardiologists would be saying this, but a relatively recent (February 2022) perspective in the Journal of the American College of Cardiology that I can only assume is meant as guidance for Cardiologists brings up the issue in the context of the potential declining efficacy of vaccines related to new variant, only to dismiss it by referencing a CDC retrospective study that suggests fewer deaths in those vaccinated and boosted in the 18-49 age group.
There are a number of problems using this reference. To start, given the massive COVID age risk gradient, the vast majority of deaths in an 18-49 year old category cluster towards the top of the category. Its not clear why the CDC, or the ACC think that a distribution of deaths between ages 18-49 that is clearly not going to be evenly distributed based on what we know of the underlying disease has much relevance when discussing a serious adverse event of vaccines that relates to 18-24 year olds. The other major problem is that there isn’t even an attempt made in this CDC report to adjust for underlying differences between the vaccinated and unvaccinated individuals, which prompts these words in the CDC publication:
…this ecological study lacked multivariable adjustments, and causality could not be determined. Possible differences in testing, infection-derived immunity, waning of vaccine-derived immunity, or prevention behaviors by age and vaccination status might partly explain differences in rates between groups.
Another CDC reference related to booster efficacy during omicron predominance suffers from the same fundamental problem – the age grouping used to evaluate the outcome of choice in this study (ED and urgent care encounters) is once again 18-49 years old, and once again, the retrospective nature of the study leaves open the very real possibility that efficacy estimates are effected by unmeasured and residual confounding.
So we now have numerous reports over the course of a year and a half from various different databases that started with an Israeli study that first reported rates of myocarditis between 1/3000-1/6000 in young men in April of 2021, with a clear signal that the Moderna vaccine’s higher dose may be leading to markedly higher rates of myocarditis than its Pfizer counterpart. Yet, US officials are inexplicably silent on the matter despite the fact Sweden, Denmark, Finland and Iceland have all paused the use of the Moderna vaccine in young people in the Fall of 2021. While I understand the fear public health officials may have about undermining vaccine confidence, this type of politics only undermines global vaccine confidence further. It should also cast a significant shadow on vaccine mandates that now serve as barriers for young people at places of work and school.
I have to make the obligatory post-script here that I oversaw the administration of hundred of mrna vaccines starting in March of 2021 in my cardiology clinic. The vaccine efficacy data for the original data was from thousands of patients and I certainly felt given the devastation wreaked on many of my patients in 2020 that the vaccines were the best chance of avoiding morbidity and mortality. The process to get the vaccines from the city department of health was a somewhat arduous 3 month process, and once the vaccines were on hand, there were daily reporting requirements that I dutifully performed for the many months we were administering vaccines. To accommodate the rush of patients, employees, volunteers, and conscripted children worked multiple weekends to administer the vaccines. So I’m especially disgusted by medical colleagues who label any concerns registered about vaccine adverse events as “anti-vaxx”. Registering concern over a vaccine adverse event does not make doctors or patients “anti-vaxx”.
Anish Koka is a Cardiologist.
Vaccine Myocarditis Update 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....
