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

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 because 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!

THCB Gang Episode 121, Thursday March 23

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

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.  

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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). 

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

Continue reading…

THCB Gang Episode 120, Thursday March 16

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.

Letting AI Physicians Into the Guild

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…

THCB Gang Episode 119, Thursday March 9

Joining Matthew Holt (@boltyboy) on #THCBGang on Thursday March 9 were writer Kim Bellard (@kimbbellard), benefits expert Jennifer Benz (@Jenbenz); Suntra Modern Recovery CEO JL Neptune; and special guest digital health investment banker Steven Wardell (@StevenWardell). Lots of conversation about Walgreens and the reaction to its non-sales of abortifacients and the possible outcomes. Then a round up of the latest in digital health financing.

If you’d rather listen, the “audio only” version is preserved as a weekly podcast available on our iTunes & Spotify channels — Matthew Holt

What Would John Henry Rauch Do Today As A HIT Entrepreneur?

BY MIKE MAGEE

Health entrepreneurs today tend to give themselves very high grades, and seem surprised when their creations fall short of expectations due to a disconnect with funders or regulators with legal authority. But Medicine isn’t fair, and genius is not that common.

What other conclusion can you draw from the thousands of references and citations featuring Philadelphia physician Benjamin Rush and his wild ideas on how to heroically treat Yellow Fever in 1793, but likely never heard of Dr. John Henry Rauch. The former signed the Declaration of Independence but directly or indirectly contributed to many an unpleasant death.  The latter saved millions and helped the AMA and the AAMC find their way out of their post-Civil War professional wilderness.

Dr. Rauch’s career, its’ span and breadth, is startling and could well serve as a yardstick for medical imagineers today. Born in Lebanon, PA in 1828, he received his Medical Degree from the University of Pennsylvania, and then opened a practice in Burlington, Iowa. He was there in 1850 for the birthing of the Iowa State Medical Society, and with their encouragement published (just five years after Iowa achieved statehood) the epic “Medical and Economic Botany of Iowa” listing 516 species, fully 23% of the known flora of the state today.

Two decades later, he was onsite in Chicago from October 8-10, 1871, when 3.3 square miles of Chicago burned to the ground taking 300 souls with it, and managed the emergency medical aftermath for the city. By then he was all too familiar with conflagration and disaster, having earned the  imprimatur of lieutenant-colonel from the Union Army as assistant medical-director of the famed Army of Virginia during the Civil War.

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OI May Be The Next AI

In the past few months, artificial intelligence (AI) has suddenly seemed to come of age, with “generative AI” showing that AI was capable of being creative in ways that we thought was uniquely human.  Whether it is writing, taking tests, creating art, inventing things, making convincing deepfake videos, or conducting searches on your behalf, AI is proving its potential.  Even healthcare has figured out a surprising number of uses.

It’s fun to speculate about which AI — ChatGPT, Bard, DeepMind, Sydney, etc. – will prove “best,” but it turns out that “AI” as we’ve known it may become outdated.  Welcome to “organoid intelligence” (OI).

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I’d been vaguely aware of researchers working with lab-grown brain cells, but I was caught off-guard when Johns Hopkins University researchers announced organoid intelligence (a term they coined) as “the new frontier in biocomputing and intelligence-in-a-dish.”  Their goal: 

…we present a collaborative program to implement the vision of a multidisciplinary field of OI. This aims to establish OI as a form of genuine biological computing that harnesses brain organoids using scientific and bioengineering advances in an ethically responsible manner.

Continue reading…

Matthew’s health care tidbits: Oh, the DEA makes me sigh….

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

I have always thought that the dual role of the Drug Enforcement Agency (DEA) was an anachronism that severely hampers America’s complex relationship with pharmaceuticals. Congress deems some medicines legal and regulates them via the FDA, and deems others illegal and tells the DEA and other law enforcement agencies to attempt to control their supply. Leaving aside the basic futility of this task, somehow DEA was also given the task of regulating the prescribers of legal prescription (and non-prescription) drugs–in particular those around controlled substances.

This has led to decades of DEA-led persecution of doctorspatients and even convenience store clerks in the name of reducing the diversion of opiates and methamphetamines. Of course going after any of these folks is much easier and less risky than hunting a Mexican cartel or busting real criminals, so it’s easy to see why the DEA has taken that approach. Has it worked in reducing the supply of opiates? Maybe. Has it had any impact on the opiate crisis? Not really. Have a whole lot of patients been caught in the crossfire? Yup.

Now the DEA is moving onto the next phase–re-regulating the online prescribing of controlled substances that was liberalized at the start of the public health emergency in 2020. As you can imagine, their proposals are not exactly bursting with reason.

The DEA is essentially banning all controlled prescribing without a face to face visit first. This is despite the fact that the demand for those mental health medications increased dramatically during the pandemic as rates of depression and anxiety went up by a factor of three. While you can argue that in 2021 and 2022 some online services (notably Cerebral) may–and I stress may–have crossed the over-prescribing line for ADHD and other conditions, there’s no evidence that what happened is any worse than the in-person care that the DEA has been inadequately overseeing for decades. More importantly, those online services have already pulled out of those exact therapeutic markets the DEA is alarmed about. Who is left providing online ADHD care? Local clinicians and reputable services. And of course DEA knows full well, and is doing nothing about, the lack of access to mental health professionals that existed long before the increase in demand.

Is there any reason to suspect DEA will improve the quality of the system dealing with these medications? Highly doubtful. There are two current examples suggesting why not. First, due to the increased demand from the pandemic induced mental-health crisis and production problems at pharma company Teva, there’s a massive shortage of ADHD medication already. The DEA could help patients out here, but have declined to increase production quotas–sending millions of patients and their parents on a wild goose chase hunting down pharmacies with actual supply of Adderall and related meds.

Secondly, the DEA wants to also ban the the online prescribing of another drug, buprenorphine, which is used to help wean patients with substance use disorder off opiates and other substances. OK, so there’s a one month grace period here but essentially this is a short-sighted ban that will directly lead to patients going to the black market to acquire opiates, leading to more addiction and death.

My conclusion is that the DEA should be removed from its oversight of licensed clinicians and that role be given to FDA or HHS. At the least these proposed  regulations should be abandoned and rolled back to what we have now. The only good news is that there is still time to comment on the regulations. I went and did so and I hope you will too. Patients have suffered enough already.

THCB Gang Episode 118, Thursday March 2

Joining Matthew Holt (@boltyboy) on #THCBGang on Thursday March 2 at 1PM PT 4PM ET are DiME CEO, & Olympic rower for 2 countries Jennifer Goldsack, (@GoldsackJen); writer Kim Bellard (@kimbbellard); benefits expert Jennifer Benz (@Jenbenz); and Suntra Modern Recovery CEO JL Neptune (@JeanLucNeptune). Today we have also a special guest –former Permanente Medical Group CEO Robbie Pearl @robertpearlmd, who is not shy with his opinions!

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.