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Month: March 2021

A Plan to Conquer U.S. Drug Shortages

By JESSICA DALEY and WAYNE RUSSELL

COVID-19 has focused the nation’s attention on the risks associated with complex, global supply chains, particularly related to healthcare products and prescription drugs. While supply disruptions of personal protective equipment (PPE) captured headlines, the pandemic also compromised the drug supply chain. With much of the United States’ generic drugs manufactured overseas, exportation bans coupled with increased global demand created significant challenges for U.S.-based providers to secure basic, life-sustaining and life-saving therapies.

As an “easy” solution, many are now calling for manufacturers to produce medications domestically. While expanding investment in U.S. drug-making capacity is a vital component of a reliable supply strategy, moving the majority of production onshore is unrealistic.

Creating a dependable drug supply chain is a multi-faceted issue that requires a thoughtful, diversified strategy.

Repairing the Market is Job #1

Drug shortages have been pervasive for more than a decade – well before COVID-19’s onset. While shortages are triggered in a number of ways, arecent Food and Drug Administration (FDA) report says economics are a main causative factor.

Almost all shortage drugs are older, low-cost generics costing less than $9/dose. Because these products don’t generate blockbuster profits, manufacturers are less willing to invest capital to improve quality, build redundant capacity or source safety stock. Over time, market competition continues to erode price and further compress profits, leading to a war of attrition where competitive players exit the market – leaving behind as few asone or two manufacturers in many important categories.

Relocating production to the United States will not address generic drugs’ inherent profitability problem. Increased regulations, environmental and otherwise, could lead to higher production costs, which begs the question: will healthcare providers trade the potential for higher costs for predictability in supply?

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THCB Gang Episode 45, Thursday March 4, 1pm PT – 4pm ET

Joining me, Matthew Holt (@boltyboy), on this week’s THCB Gang will be THCB regular writer Kim Bellard (@kimbbellard), medical historian Mike Magee (@drmikemagee),  policy & tech expert Vince Kuraitis (@VinceKuraitis),  patient safety expert and all around wit Michael Millenson (@MLMillenson), and consumer expert and current President of the Medical Board of California, Denise Pines.

Vaccines at warp speed, some “Neanderthal” state governors opening up, but also a pandemic bill passes the house with some health policy implications. Plus lots of fun and games in the world of digital health and startup health plans. We should have something to discuss!

You can see the video below live and the audio will be on our podcast channel (Apple/Spotify) from Friday

Wanna Buy Some Bitcoin

By KIM BELLARD

To healthcare organizations, digital currency is the thing you’re forced to deal with when your systems are held for ransomware.  To the rest of the world, it’s increasingly starting to look like the future.

Tesla caused somewhat of a stir last month when it disclosed that it had bought $1.5b of bitcoin.  It also said it would start accepting bitcoin payments for its cars.  CEO Elon Musk added to the furor, saying: “I do at this point think bitcoin is a good thing. I’m late to the party, but I am a supporter of bitcoin.” 

Most of us are late to the digital currency party. 

Bitcoin’s market cap hit $1 trillion in mid-February, although it now hovers just over $900b, with Ethereum another almost $200b.  Tesla is making more money from its bitcoin investment than from its core businesses.  In the scheme of global financial markets, digital currencies are still small, but are not something any CFO should be ignoring.  

Tesla is not the only major company accepting digital currencies; Overstock, Starbucks and Twitch do, as three wildly different examples.  Twitter is thinking about paying vendors or even employees with bitcoin.  Facebook expects to launch its own cryptocurrency this year. 

I’m not aware, though, of any major healthcare companies accepting or paying with digital currencies.  No Tesla-type breakthroughs in healthcare. 

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Moderna’s “Secret Sauce”

By MIKE MAGEE

This week J&J gained FDA approval for their 1-shot COVID vaccine, leading optimists like Pfizer Board member, Scott Gottlieb, to predict that we will have 100 million shots out there by the end of April, and on-demand offerings for the general public. In the race toward herd immunity, we could easily ignore a revolutionary change in pharmaceutical design and manufacturing occurring under our noses.

Case in point: Moderna – subject of a recent case study by Marco Iansiti, Karim Lakhani, Hannah Mayer, and Kerry Herman in the Harvard Business Review.

Moderna – labeled by its CEO as “a technology company that happens to do biology” – was founded in 2010, with $5.1 billion in venture capital backing,  “designed from the ground up as a digital biotech company with a factory for in-house manufacturing capabilities.” Up to this point, as they entered their 11th year, they had not brought a single product to market.

Moderna was the child born of Cambridge-based Flagship, run by Noubar Afeyan, an MIT bioengineer and world leader in bio-instumentation. His raison d’etre was “radical innovation.” He not only wanted to do big things, but do them faster than anyone else. As he said, “Asking ‘What if?’ questions propels you far into the future. It may be unrealistic or overly optimistic, but that’s how radical innovation happens.”

To accomplish this outsized ambition, he invested in a four-step process:

1.   Generate break-through innovation hypotheses (what-if’s).

2.   Explore the hypothesis. If it looks good, set-up a prototype company.

3.   If initials prove out, go permanent with a New Company.

4.   If promising, spin it off as a Growth Company.

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#Healthin2Point00, Episode 188 | MDLive, Devoted Health, Medisafe, January AI

Today on Health in 2 Point 00, we cheat a little bit and go overtime. On Episode 188, Jess asks me about MDLive getting acquired by Cigna’s Evernorth division, Devoted raising a whopping $380 million, Medisafe getting $30 million in a round led by Sanofi, and January AI raising $8.8 million bringing its total up to $21 million. —Matthew Holt

Can You Trust Digital Health Firms To Trust You?

By MICHAEL MILLENSON

What kind of health care organization would let a 10-year-old child make an instructional video for patients? And what might that decision teach health tech companies trying to gain the trust of consumers? 

I found myself pondering those questions while listening to Dr. Peter Margolis, co-chair of a National Academy of Medicine committee on health data sharing and stakeholder trust and a speaker at the recent (virtual) Health Datapalooza annual conference. Margolis is also co-director of the Anderson Center for Health Systems Excellence at Cincinnati Children’s, the institution that allowed 10-year old kids with a condition necessitating a feeding tube to create videos showing other children how to insert one. Parents, meanwhile, were recruited to help develop new technology to help their child.

The payoff for this and similar efforts by the shared learning communities Cincinnati Children’s has birthed has been significantly improved outcomes and national renown. But for this type of initiative to succeed, Margolis told me when I visited a few years ago, clinicians and administrators “have to be comfortable with a very different kind of role.” 

As consumers gain access to information once limited to medical insiders, that advice seems increasingly prescient. Federal rules requiring providers to make electronic health data available to patients at no cost take effect April 5.  Meanwhile, voluntary electronic sharing of physician clinical notes is rapidly morphing from the unthinkable to the unremarkable, while apps to make all this data actionable are proliferating. As a result, long-simmering issues related to transparency and trust and are coming to the fore.

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