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Matthew’s health care tidbits: The drug model for DTx was wrong

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Each time I send out the THCB Reader, our newsletter that summarizes the best of THCB (Sign up here!) I include a brief tidbits section. Then I had the brainwave to add them to the blog. They’re short and usually not too sweet! –Matthew Holt

If you were to look at pharmaceuticals in the US you might make three observations. 1) They are the most important way health conditions are helped, cured or eradicated. 2) The way they are delivered to patients (via pharmacies) is very badly integrated with the health care delivery system. 3) They are way too expensive.

OK, so those are my observations not yours but I think you’ll agree they’re all true.

Now I am going to tell you that we’ve developed a technology that lives in your phone that has the same impact as a drug, if not better. It will cure your depression, insomnia, pain, even maybe Alzheimer’s. And because it is a software product, not a drug you ingest, it has no (or at least few) dangerous side effects. And because it’s software and easy to distribute to millions of people, it can be cheap. Wouldn’t it be a great idea for the people managing health conditions—a patient’s clinical care team—to directly integrate this technology into the care they are delivering?

Some of the people building these technologies agreed, but most of them decided that they liked the current model of prescription pharmaceuticals. They built these cool technologies and decided to distribute them via physician prescriptions and charge for them like pharmaceuticals. To do that, they had to get FDA approval for their “Prescription Digital Therapeutics” (DTx) via expensive clinical trials. Additionally, of course, they hoped to get government-backed monopoly status–called patents in the pharma business.

In general in health care, the FDA regulates things that go into the body and may cause damage. The rest of clinical medicine has great latitude for experimentation, technique and technology development, and allows others to copy what works.

The companies heading down the Prescription DTx route also used the business model of regular pharma and biotech companies. They raised large amounts of money up front, applied for patents, went through the FDA clinical trial process, and hoped to charge significant amounts per patient once their DTx were approved and prescribed.

None of them seemed to care that if they succeeded, their DTx would necessarily only be accessed by a small population at great cost. None of them seemed to notice that their DTx were usually an electronic distillment of teaching, patient advice, coaching therapy or other activities that look more like extensions of traditional clinical care, as opposed to ingested pharmaceuticals.

Many of these companies are now in deep trouble. They raised money when it was cheap or even, like Pear and Better Therapeutics, took advantage of the SPAC vehicles to IPO. Now they have found that they cant get their DTx through the FDA process quickly enough or aren’t seeing the prescribing numbers they needed to make their products a success. Since the digital health stock crash, it’s very hard for them to raise more money. Pear Tx this week announced it was trying to sell itself.

My hope is that we get a reset. I want digital therapies that are extensions of clinical care to be widely used and widely available as part of the care process, and for their care to be integrated into clinical care –rather than to be prescribed and then delivered by some third-party. And, because they are software and software scales, I want them to be cheap. Hopefully that is the future of DTx.

On second thoughts, that wouldn’t be a bad future for regular pharmaceuticals either!

Nils Bottler, Angelini Ventures

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I’ve been friends with Roberto Ascione for many years. Roberto is a keen Napoli fan who on the side runs the Healthware Group and also the Frontiers Health Conference that I’ve been going to for many years (and where Jess DaMassa is co-MC). Recently Healthware acquired the media company pharmaphorum and hired star reporter (and another friend) Jonah Comstock, ex MobiHealthNews and HIMSS Media. This is THCB’s second cross-posting with pharmaphorum.—Matthew Holt

Nils Bottler, who recently joined Angelini Ventures as Principal, is an avid skier, surfer, and digital health investor based in Berlin. In a new podcast, he spoke with Paul Tunnah, pharmaphorum founder, about his career, the German start-up landscape, and where Angelini Ventures aims to have an impact.

THCB Gang Episode 121, Thursday March 23

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Joining Matthew Holt (@boltyboy) on #THCBGang on Thursday March 16 at 1PM PT 4PM ET are futurist Ian Morrison (@seccurve); writer Kim Bellard (@kimbbellard); Suntra Modern Recovery CEO JL Neptune (@JeanLucNeptune); and Olympic rower for 2 countries and all around dynamo DiME CEO Jennifer Goldsack, (@GoldsackJen).

The video will be below. If you’d rather listen to the episode, the audio is preserved from Friday as a weekly podcast available on our iTunes & Spotify channels

Throw Away That Phone

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By KIM BELLARD

If I were a smarter person, I’d write something insightful about the collapse of Silicon Valley Bank. If I were a better person, I’d write about the dire new UN report on climate change. But, nope, I’m too intrigued about Google announcing it was (again) killing off Glass. 

It’s not that I’ve ever used them, or any AR (augmented reality) device for that matter. It’s just that I’m really interested in what comes after smartphones, and these seemed like a potential path. We all love our smartphones, but 16 years after Steve Jobs introduced the iPhone we should realize that we’re closer to the end of the smartphone era than we are to the beginning. 

It’s time to be getting ready for the next big thing.  

—————

Google Glass was introduced ten years ago, but after some harsh feedback soon pivoted from a would-be consumer product to an Enterprise product, including for healthcare. It was followed by Apple, Meta, and Snap, among others, but none have quite made the concept work. Google is still putting on a brave face, vowing: “We’ll continue to look at ways to bring new, innovative AR experiences across our product portfolio.”  Sure, whatever.

It may be that none of the companies have found the right use case, hit the right price point, adequately addressed privacy concerns, or made something that didn’t still seem…dorky. Or it may simply be that, with tech layoffs hitting everywhere, resources devoted to smart glasses were early on the chopping block. They may be a product whose time has not quite come…or may never.   

That’s not to say that we aren’t going to use headsets (like Microsoft’s Hololens) to access the metaverse (whatever that turns our to be) or other deeply immersive experiences, but my question is what’s going to replace the smartphone as our go-to, all-the-time way to access information and interact with others? 

We’ve gotten used to lugging around our smartphones – in our hands, our purses, our pants, even in our watches – and it is a marvel the computing power that has been packed into them and the uses we’ve found for them. But, at the end of the day, we’re still carrying around this device, whose presence we have to be mindful of, whose battery level we have to worry about, and whose screen we have to periodically use. 

Transistor radios – for any of you old enough to remember them – brought about a similar sense of mobility, but the Walkman (and its descendants) made them obsolete, just as the smartphone rendered them superfluous.  Something will do that to smartphones too.

What we want is all the computing power, all that access to information and transactions, all that mobility, but without, you know, having to carry around the actual device. Google Glass seemed like a potential road, but right now that looks like a road less taken (unless Apple pulls another proverbial rabbit out of its product hat if and when it comes out with its AR glasses). 

—————-

There are two fields I’m looking to when I think about what comes after the smartphone: virtual displays and ambient computing. 

Continue reading…

Interview with Ogi Kavazovic, CEO of House Rx

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Ogi Kavazovic, CEO of House Rx joined Matthew Holt to explain how his company is trying to ungum the specialty pharmacy market. Its a huge market with a few huge oligopolies in charge of it, and Ogi thinks there is room to work directly with the clinics responsible for most patients using injectables and provide them a better and cheaper experience. Last year they raised $30m in a round led by Bessemer, but as Ogi says there’s along way to go!

THCB Gang Episode 120, Thursday March 16

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Joining Matthew Holt (@boltyboy) on #THCBGang on Thursday March 16 at 1PM PT 4PM ET were futurist Ian Morrison (@seccurve); medical historian Mike Magee (@drmikemagee); patient safety expert and all around wit Michael Millenson (@mlmillenson); and delivery & platform expert Vince Kuraitis (@VinceKuraitis). Lots of discussion about the Walgreens not selling abortifacients, Silicon Valley Bank’s impact on digital health, and how hospitals are doing.

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.

Two Patients With More Than One Diagnosis

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BY HANS DUVEFELT

I have written many times about how I have made a better diagnosis than the doctor who saw my patient in the emergency room. That doesn’t mean I’m smarter or even that I have a better batting average. I don’t know how often it is the other way around, but I do know that sometimes I’m wrong about what causes my patient’s symptoms.

We all work under certain pressures, from overbooked clinic schedules to overfilled emergency room waiting areas, from “poor historians” (patients who can’t describe their symptoms or their timeline very well) to our own mental fatigue after many hours on the job.

My purpose in writing about these cases is to show how disease, the enemy in clinical practice if you will, can present and evolve in ways that can fool any one of us. We simply can’t evaluate every symptom to its absolute fullest. That would clog “the system” and leave many patients entirely without care. So we formulate the most reasonable diagnosis and treatment plan we can and tell the patient or their caregiver that they will need followup, especially if symptoms change or get worse.

Martha is a group home resident with intellectual disabilities, who once underwent a drastic change in her behavior and self care skills. She even seemed a bit lethargic. A big workup in the emergency room could only demonstrate one abnormality: Her head CT showed a massive sinus infection. She got antibiotics and perked up with a ten day course of antibiotics.

A month later, her condition deteriorated again. It was on the weekend. This time she had a mild cough. Her chest X-ray showed double sided pneumonia. She got antibiotics again and started to feel better.

Continue reading…

Letting AI Physicians Into the Guild

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BY KIM BELLARD

Let’s be honest: we’re going to have AI physicians.  

Now, that prediction comes with a few caveats. It’s not going to be this year, and maybe not even in this decade. We may not call them “physicians,” but, rather, may think of them as a new category entirely. AI will almost certainly first follow its current path of become assistive technology, for human clinicians and even patients.  We’re going to continue to struggle to fit them into existing regulatory boxes, like clinical decision support software or medical devices, until those boxes prove to be the wrong shape and size for how AI capabilities develop.

But, even given all that, we are going to end up with AI physicians.  They’re going to be capable of listening to patients’ symptoms, of evaluating patient history and clinical indicators, and of both determining likely diagnosis and suggested treatments.  With their robot underlings, or other smart devices, they’ll even be capable of performing many/most of those treatments. 

We’re going to wonder how we ever got along without them. 

Many people claim to not be ready for this. The Pew Research Center recently found that 60% of Americans would be uncomfortable if their physician even relied on AI for their care, and were  more worried that health care professionals would adopt AI technologies too fast rather than too slow.  

Still, though, two-thirds of the respondents already admit that they’d want AI to be used in their skin cancer screening, and one has to believe that as more people understand the kinds of things AI is already assisting with, much less the things it will soon help with, the more open they’ll be.    

People claim to value the patient-physician relationship, but what we really want is to be healthy.  AI will be able to help us with that.

Continue reading…

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.

Continue reading…

Practicing at the Top of Your License is Not an Option for Primary Care Physicians

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BY HANS DUVEFELT

You don’t really need a medical degree to know how to follow an immunization schedule, to recommend a colonoscopy, or order a screening mammogram (as long as, in this country, there is a standing order – in some places, mass screenings are done outside the primary care system).

You also don’t really need a medical degree to enter data into an EMR.

And when you decide to order a test, how many of the EMR “workflow” steps really require your expertise? I mean, borrowing from my iPhone, you could say “order a CBC” and facial recognition could document that you are the ordering physician. Really!

And you don’t really need a medical degree to, as I put it, open and sort the (electronic) mail; an eye doctor’s report comes in and if the patient is a diabetic, I have to forward it to my nurse for logging, and if not a diabetic, just sign off on it. And don’t imagine there is time in our day, evening or weekend to actually read the whole report. Patient A saw their eye doctor – check. Next…

Primary care in this country is pathetically arcane and inefficient. And we have a shortage of primary care physicians, they say. If we could all practice at the top of our license, perhaps not. It’s time to reimagine, reinvent, reinvigorate!

Hans Duvefelt is a physician, author, and writer of “A Country Doctor Writes.”

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