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Truth and Trust in Science: Are They Negotiable?

BY MIKE MAGEE

“The key is trust. It is when people feel totally alienated and isolated that the society breaks down. Telling the truth is what held society together.”

Those words were voiced sixteen years ago in Washington, D.C. It was October 17, 2006. The HHS/CDC sponsored workshop that day was titled “Pandemic Influenza – Past, Present, Future: Communicating Today Based on the Lessons from the 1918-1919 Influenza Pandemic.”

The speaker responsible for the quote above was writer/historian and Johns Hopkins School of Public Health adviser, John M. Barry. His opening quote from George Bernard Shaw set a somewhat pessimistic (and as we would learn 14 years later, justified) tone for the day:

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The Society for Participatory Medicine Presents a Creative Learning Exchange: Community Health Access and Equity 

I’ve been on the board of the Society for Participatory Medicine for a few years and we are kicking off a series of “Creative Learning Events”. There’ll be two in the balance of 2022 and hopefully one a quarter thereafter. Should be great in-person AND online exchanges about getting participatory medicine into the hear of the health care system. Here’s details on the first one, October 20, in Boston and everywhere else!–Matthew Holt

Participatory Medicine is a movement in which patients, caregivers and healthcare professionals actively collaborate and encourage one another as full partners in healthcare. 

The Society for Participatory Medicine with the support of our sponsor NRC Health Presents A Creative Learning Exchange(CLE): Community Health Access and Equity

Date: October 20, 2022 Time: 12:00 noon – 4:00pm (Lunch Is Included for In-Person)

Location: Brown Advisory, 100 High Street, 9th Floor, Boston, MA 02110

For more details and to REGISTER TODAY click here.

The Society for Participatory Medicine believes that the culture of healthcare is not benefiting everyone equally and needs to change. And healthcare won’t get better until healthcare culture gets better. We want to drive this change by enabling collaboration, education, information sharing, and communication among patients, caregivers, and health care professionals. Join the movement! 

This Creative Learning Exchange, in-person and online hybrid event, will be highly interactive and participatory, using a ‘Neighbors at Each Table’ approach to engaging you in facilitated discussion and brainstorming. 

These discussions will focus on applying the Participatory Medicine Manifesto behaviors in culturally and racially diverse communities to enable access and equity in care. Your ideas, insights and solutions that emerge will be curated by SPM to build a toolkit of participatory medicine guidelines. These will be shared with you and through SPM’s social networks, website and blog. 

For more details and to REGISTER TODAY click here.


Thank you to our series sponsor NRC Health. Thanks to Massachusetts General Hospital Equity & Community Health for sponsoring the meal. Thanks for Brown Advisory for proving the venue & AV.

The Future of Clinical Trials at Pfizer

BY JESSICA DaMASSA

From de-centralized clinical trials to real world data (RWD), real world evidence (RWE), and even social media, the future for clinical research at Pfizer sounds increasingly tech-enabled and focused on meeting and engaging patients where they are.

Pfizer’s Head of Clinical Trial Experience, Judy Sewards, and Head of Clinical Operations & Development, Rob Goodwin, drop in to chat about what Pfizer’s approach to clinical research looks like now, after the rapid evolution it underwent to “lightspeed” the development of the Covid-19 vaccine.

The big change? Rob says they are “obsessed” with de-centralized trials, with nearly 50% of clinical trial visits still happening virtually. And, beyond the convenience factor, both point to de-centralization as a critical factor in being able to recruit more patients into trials as well as improve the diversity of their participant groups. In the end, the decentralized approach, says Judy, is “not just a matter of equity, but good science as well.”

And what about improvements to the cost of drug development? Is it too soon to tell if de-centralization will make an impact on the bottom line? Innovation may be expensive to implement at first, but, explains Rob, “If you can recruit your trial faster, overall, the cost of development goes down and speed to the patient goes up.”

We chat through the full suite of benefits that de-centralized clinical trials are bringing Pfizer and its patient populations, and get into the utility of real-world data, which also saw new notoriety when the Covid-19 vaccine was being developed. How is RWD impacting clinical research even when it’s not being used as evidence in a regulatory approval process? Watch and find out more about how data innovation is shaping the future of pharma!

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