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When Medical Error Becomes Personal, Activism Becomes Painful

BY MICHAEL MILLENSON

In the mid-1990s, researching a book about the quality of medical care, I discovered how the profession had for years been ignoring evidence about the appalling death toll from preventable medical error. Though I’d never myself experienced an error, I became an activist.

Recently, however, a relative was a victim, and the frustrating persistence of error became personally painful.

Thanks to my relative being acutely aware of the need to be alert (and a bit of luck), no harm was caused by what could have been a serious medication mistake. That was the good news. The bad news is that even Famous Name Hospitals, like the one where my relative was treated, are rarely doing everything possible to forestall the impact of inevitable human fallibility.

September 17 was World Patient Safety Day, and the theme for the next 12 months is “Medication Without Harm.” That makes this an opportune time to examine more closely what the profession euphemistically calls a “medication misadventure.”

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Goliath, Meet David

BY KIM BELLARD

I’m a sucker for underdog stories.  I love unconventional wisdom overthrowing conventional wisdom. I’m deeply suspicious of Big Tech, Big Oil, and big health.  I know unfettered competition is not always to my benefit but get nervous when I don’t really have many options.  

So when I read that Google is starting to worry about a threat to its search dominance and that TikTok and other social media giants are scared of a rival start-up, well, count me in. I just wish it was health care goliaths that were worried.

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#HealthTechDeals Episode 46 | Redesign Health, Theranica, Soda Health, and Kyruus

It’s that time of the year! Summer is over and it’s conference season! The Rock Health Summit was a fun session, the highlight of which was diversity, equity, inclusion, and representation. Tune in for Jess’s and my thoughts on the summits, the end of the world, and new deals: Redesign Health raises $65 million, Theranica raises $45 million, Soda Health raises $25 million, and Kyruus buys Epion Health.

-Matthew Holt

Constructed of star dust, will Guardian Angels continue to exist?

BY MIKE MAGEE

EXCLUSIVE: Royal beekeeper has informed the Queens bees that the Queen has died and King Charles is their new boss in bizarre tradition dating back centuries. … He placed black ribbons tied into bows on the hives, home to tens of thousands of bees, before informing them that their mistress had died.”

So read John Dingwall’s exclusive in the Daily Mail posted at 03:48 EDT, 10 September 2022. In defense of what might first appear a bizarre practice, others were careful to provide evidence that the practice, of informing fellow natural creatures of important human losses, is well documented in art and literature, such as in “Der Bienenfreund” (“The Bee Friend”), an 1863 painting by the German artist Hans Thoma.

That painting arrived on the scene nine years after the death of German philosopher Friedrich Wilhelm Joseph von Schelling, a stalwart of “German Idealism.” His focus (in part) was on “humankind’s relationship to nature,” a subject that has received a spotlight as our planet’s “climate emergency” status  has become undeniable.

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

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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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 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.

#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 not? Jess DaMassa almost lets me takeover, but we know who she really wants in charge! Matthew Holt

“Beyond Nicotine”: Tobacco 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 vaping 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. 

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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 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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Putting the “e” in DNA

BY KIM BELLARD

The Wall Street Journal had a great article a couple days ago that tickled my fancy on two fronts: DNA, and the deep ocean.  Both fascinate me. It introduced me to a term I’d not heard before but have now discovered is a thing: “eDNA.”  It’s something I suspect we’ll be hearing more about, and a technique we’ll be using much more, in the years to come.

The article, Finding New Drugs From the Deep Sea via ‘eDNA’, talks about a different approach to discovering potential sources of new medicines: “environmental DNA,” or eDNA.  As the US Geological Survey describes it: “Environmental DNA (eDNA) is nuclear or mitochondrial DNA that is released from an organism into the environment.” You may not want to know this, but “Sources of eDNA include secreted feces, mucous, and gametes; shed skin and hair; and carcasses.”

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