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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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The Paradigm Shift That Wasn’t: The ISCHEMIA Trial

By ANISH KOKA

A recent email that arrived in my in-box a few weeks ago from an academic hailed the latest “paradigm shift” in cardiology as it relates to the management of stable angina.  (Stable angina refers to chronic,non-accelerating chest pain with a moderate level of exertion).  The points made in the email were as follows (the order of the points made are preserved):

  1. The financial burden of stress testing was significant (11 billion dollars per annum in the USA!)
  2. For stable CAD, medical treatment is critical.  We now have better medical treatments than all prior trials including ischemia. these include PCKS9 Inhibitor, SGLT2-i, GLP1 agonists Vascepa and others
  3. CTA coronaries is by far the most important single test for evaluation of these patients
  4. ” the paradigm of ischemia testing may have come to an end”
  5. For stable angina (not ACS!) in most cases, the decision on revascularization should be based only on symptoms alleviation (as no survival benefit).

The general public should find it interesting, and not a random coincidence that the first point immediately gets to the financial burden of stress testing in a communication that is supposed to assess the level of evidence for the management of coronary artery disease. Imagine a cardiologist enters your exam room to talk about the chest pain you get every time you run up a flight of steps, and starts off the conversation with how much the societal cost of stress tests are.  The cost of care is certainly a relevant concern, especially if it’s to be borne directly by the patient, but it would seem that the decision of whether a therapy is effective or not should be divorced from how much some bean counter decides to price the therapy to generate a certain return on investment.  As such, the discussion that follows will omit any consideration of cost when evaluating the new ‘paradigm shift’ in management of coronary disease that is apparently upon us.

This particular debate boils down to the relevance of diagnostic testing for coronary artery disease.  The traditional approach to testing is a functional test that utilizes the uptake of radioactive isotope injected into a patient during stress and rest conditions to identify mismatches in blood flow in the two states to identify myocardial ischemia.  The amount of ischemia can be quantified as percent of total myocardium, and has been well correlated with prognosis.  Having lots of ischemia typically means a much shorter lifeline than having little or no ischemia.  The accepted paradigm in Cardiology has been to use traditional stress testing to triage patients to ‘conservative’ medical therapy or an invasive approach to bypass or open arteries via stents or coronary bypass surgery. 

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Buoy Health Wins Over Three Health Plans, Turns Symptom Checking into Patient Decision-Making

By JESSICA DaMASSA, WTF HEALTH

Symptom checker startup Buoy Health’s $37.5M Series C caught a lot of attention among health tech market watchers because of the collaborative support the funding round garnered from health plans. THREE payor orgs – UnitedHealth’s Optum, Humana, and Cigna – participated in the round, and co-founder and CEO Andrew Le is here to tell us why.

What’s interesting is how the health tech startup’s model has evolved past “symptom checking” and into patient decision-making to better solve the underlying uncertainty that typically causes a patient to “shotgun into care” that’s often a poor fit clinically AND financially. “If you don’t solve the clinical uncertainty first,” says Andrew, “then nothing else matters.” Health plans, though, are likely also seeing the potential of making sure that their members are routed to the right kind of “covered” care. And Buoy’s big plan is to help that along with a full-on marketplace of curated solutions – think telehealth, digital health apps, digital therapeutics, and so on – that round out the benefit design of a traditional health plan. Suddenly, symptom checking seems a means to a very different end…

#Healthin2Point00, Episode 187 | Redox, Nanit, Innovacer & MindMed

Today on Health in 2 Point 00, Jess makes me pronounce some impossible words while we cover lots of funding deals. Redox has raised $45 million in a Series D, bringing their total up to $95 million. Nanit, another baby monitoring company, raises $25 million in a Series C, Innovaccer raises a $105 million D round, and psychedelic biotech company MindMed acquires digital health company HealthMode. —Matthew Holt

Wiping the Sleep From Our Eyes: The Pandemic Plan Trump Ignored

By MIKE MAGEE

When awakening from a long sleep, there is a transition period, when the brain struggles momentarily to become oriented, to “think straight.” When the sleep has extended four years, as with the Trump reign, it takes longer to clear the sleepy lies from your eyes.

We are emerging, but it will take time and guidance. This week President Biden and our First Lady showed us the way. As we together observed the startling passage of a half million dead, many needlessly, from the pandemic, the President gave us a crash course on grief. He compared it to entering a “black hole”, and acknowledged that whether you “held the hand” as your loved one passed on, or were unable (by logistics or regulation) to be there to offer comfort, time would heal. “You have to believe me, honey!”, as he is so prone to say.

As important, we saw the First Lady, without fanfare or concious need for attention, at one moment, draw close to him, as she sensed that he was about to be overcome by his own sadness, and place her hand simply on his back, patting him gently, knowing that this was enough to get him through. She, by then, had done this many times before.

And we saw the Vice President and her husband, across from the first couple, there only for support. This was neither a speaking role or super-ceremonial. It was humble. It was supportive. It was human, and far away from a predecessor who for four years had to fawn, and lie, and grovel to satisfy his Commander-in-Chief.

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