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Category: Health Policy

Correlative Adventures with COVID

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By ANISH KOKA

“The patient in room 1 should be a quick one, its an addon, they just need a prescription for ivermectin”

I’m a bit puzzled by this sentence from my assistant doing his best to help me through a very busy day in the clinic that I’m already behind in. I walk into the room, a script pad stuffed into my hand as I enter the room, to meet a very nice couple.  The wife sits patiently with hands crossed on the exam table. 

“So, you’re here for Ivermectin?”, I ask.

Why yes, a trip to Texas is planned.. COVID is in the air, the internet, and some important people who have ‘inside knowledge’ have raised doubts about the vaccine.  Some other people who quite possibly could be the same people, have also suggested prophylactic ivermectin is the better bet to prevent these good people from catching COVID.

Ivermectin is a drug  known to work against parasites.  The virus angle relates to in vitro data that suggests Ivermectin inhibits the host importin alpha/beta-1 nuclear transport proteins, which are part of a key intracellular transport process that viruses use to enhance infection by suppressing the host’s antiviral response.  In addition, ivermectin may interfere with the attachment of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein to the human cell membrane. Ivermectin demonstrates a broad spectrum of activity in-vitro against a variety of viruses like dengue, Zika, HIV, and yellow fever.  Unfortunately, despite this in vitro activity, no clinical trials have reported a clinical benefit for ivermectin in patients with these viruses.

Ivermectin does inhibit Sars-Cov2 viral replication in cell cultures.  However, pharmacokinetic studies suggest that achieving the plasma concentrations necessary for the antiviral efficacy detected in vitro would require administration of doses up to 100-fold higher than those approved for use in humans. Even though ivermectin appears to accumulate in the lung tissue, predicted systemic plasma and lung tissue concentrations are much lower than 2 µM, the half-maximal inhibitory concentration (IC50) against SARS-CoV-2 in vitro. Subcutaneous administration of ivermectin 400 µg/kg had no effect on SARS-CoV-2 viral loads in hamsters, though there was a reduction in olfactory deficit and a reduction in the interleukin (IL-6:IL-10) ratio in lung tissues.

Since the pandemic began, there have been a number of small randomized controlled trials of ivermectin in mild COVID patients that show more rapid viral clearance, but not too much else.   The prophylaxis data is considerably more sparse, and is of the retrospective variety.  Basically take a number of countries that use Ivermectin variably and compare the incidence of COVID in those countries. 

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Moderna’s “Secret Sauce”

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

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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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Post Pandemic Re-Entry

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By ALICIA MORTON FARLESE

Not in our lifetimes has humanity experienced such a pervasive, profound, and prolonged retreat from “normal lives.” This. Will. Not. Be. Easy. 

While the conversation about the serious negative impact on our behavioral health has started, we also suffer from a scarcity of behavioral health professionals, and equitable access to these essential resources.  

More than ever, we all seem to “get it” and are reflexively more forgiving when we hear that some of us are struggling with the behavioral health consequences of Covid -19 — we’ve all been there to some extent over the past year.  

As a Veteran, I’m accustomed to reintroduction plans, designed with thoughtful consideration, anticipatory preparation, and behavioral health resources for military members (and their families) returning from deployment. As we approach normalcy, a similar reentry will soon begin, yet we’re not talking about what to expect and how our behavioral health needs will be addressed. Where are the post-pandemic re-entry plans? Yes – we want to get back – but just as the military members need level-setting guidance, support, and understanding as they return “home” so do all of us as we begin our reentry. 

Our battlefield has been the isolation, home-schooling, remote working, laid-off, caring-for (and saying goodbye to) loved ones for the last 11 months. It has been the tangled web of emotions: tragic, heartwarming, frustrating, endearing, exhausting and confusing. Emerging from this Nebel des krieges will not be the walk in the park that we hopeful humans imagine it to be.  Now is the time to plan for re-entry. 

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Saints, Sinners, & the Spirituality of the SPAC Church | Politics, Policy, Power

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By EMILY EVANS

Takeaway: Policy changes have overtaken many health care SPACs but that won’t stop a lot of telegenic advocates; something is sure to go wrong.

Politics. Something is sure to go wrong.

Over 400 SPACs have formed and about 100 business combinations announced. At least as far as health care goes, excluding biotech and pharma, the quality of the business combinations has thus far been uninspiring.

Deerfield’s CareMax/IMC Medical, Jaws’ Cano Health are focused on the very crowded Medicare Advantage market just as demographic realities require attention to shift toward younger people. Falcon’s ShareCare, GigCapital2’s Uphealth/Cloudbreak, Hudson’s Talkspace are yet more digital platforms to manage care. VG’s 23andMe wants to monetize all the genetic data it has collected through drug development.

Absent durable business models that address the core challenges of health care such as price, efficiency and quality, SPACs seem to be relying on charismatic personalities to win over investors, great and small, regardless of their experience or credibility. So much so, Twitter entreaties from Chamath Palihapitiya’s fan-base have taken on the tone of religious followers. “@chamath give @Clover_Health some love on Valentine’s Day what’s your position are you optimistic, excited, hopeful of its future? We would love to hear from you…”

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A Stretched Profession: How Much Longer Can Healthcare Workers Hang On

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By JUDY GAMAN

Among those in the field, it’s been referred to as the Covid Tour of Duty. Doctors, nurses, and support staff working around the clock on high alert, in many cases seeing the worst effects of our world-wide battle against the pandemic. Even those non-hospital workers, especially those in primary care, are being pushed to their limits with no definitive end in sight.

Long before the pandemic, the alarm bells were sounded due to an aging population, which by nature requires more healthcare. That population was being met with shortage of physicians and nurses. Couple that with the pandemic—which has claimed the lives of many healthcare workers, and burned out those that remain—and the shortage becomes the next industry crisis.

Patients with post-Covid sequelae will need ongoing care and may require more visits to their primary care for years to come. Without an adequate push for educating more doctors and nurses, the American population will be met with a continued shortage, now of massive proportion. Opening borders during a pandemic is equivalent to pouring gasoline on the fire, as the country is currently short pressed to take care of their own.

A survey from Mental Health America ( https://mhanational.org/ ) that surveyed healthcare workers from June through September 2020 showed that more than 75% were frustrated, exhausted or overwhelmed. In addition, 93% were experiencing symptoms related to stress. Those same workers are still going full-speed-ahead five months later.

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Modern Day “Victory Gardens” – Planting the Seeds for Covid Vaccination Success

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By MIKE MAGEE

In the wake of Pearl Harbor, FDR found our nation ill-prepared for war. He lacked manpower and tools. In response, he took deliberative action with the support of Congress, drafting soldiers and redirecting supply chains toward weapons of war. Compliance was requested, then demanded. Those industries that served, including Pfizer with penicillin production, benefited in the short and long-term.

FDR not only harnessed the power of industry and science, and ramped up the military, but also asked every family and every community to participate in the war effort. Community volunteering soared, and sacrifice for the public good was the rule, not the exception.

One idea was “victory gardens”, planted in back yards,  to allow stressed food manufacturers the ability to focus on meeting the demand to “feed the troops.”  These gardens in 1943 provided 1/3 of all the vegetables consumed in the states that year.

President Biden now finds himself in a similar predicament – the need to redirect our vast industrial productive capacity while mobilizing our citizens to both support and participate in vaccination efforts.

Our President and his team understand that interventional and privatized high science is of little avail if that science (in this case vaccines) is unable – by limited supply or logistic ineptitude or the absence of public trust – to find it’s way efficiently and quickly into the arms of our citizens.

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Pledge to the Participatory Medicine Manifesto!

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By THE SOCIETY FOR PARTICIPATORY MEDICINE

We are excited to announce that the campaign to pledge to the Participatory Medicine Manifesto is launching today — and we need your support!

Our Participatory Medicine Manifesto is a call to action for patients, caregivers and health care professionals to equally share decision-making and respect one another. 

We want you and your organization to help us fix a broken healthcare system from the ground up. We want to put democracy back into the culture of healthcare by enabling patients, healthcare professionals and caregivers to all have an equal voice. We need your influence to inspire people. We will list individuals and organizations that support the Manifesto.

Please view and sign the SPM Manifesto Pledge today 

We have designed a promotional campaign encouraging people to pledge to the Participatory Medicine Manifesto. As part of this campaign, we created a pledge form and social media toolkit for people and organizations to use in spreading the work about Participatory Medicine.

And spread the word to your colleagues and friends to help us reach our goal. After you pledge you will find the easy to use social media toolkit.

We greatly appreciate your help and support!

Eric Bersh, Judy Danielson, Kevin Freiert, Matthew Holt, Dr. Danny Sands, Amber Soucy—all board members of SPM

Pledge Today! 

PS – Please share with your friends & followers!

If It Ain’t Real Time, It Ain’t Really Real

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By KIM BELLARD

Here’s a damning opening paragraph from an article in The New York Times about the frustrations that COVID-19 vaccinations are causing:

For a vast majority of Americans, a coronavirus vaccine is like sleep for a new parent: It’s all you can think about, even if you have no idea when you will get it.

Because, as Kaiser Health News reported: “Many states don’t know exactly where the doses are, and the feds don’t either.” 

Think about that: in 2021, we can’t – or don’t – track something as vital as where vaccine doses are, in the midst of the pandemic they were designed in record time to mitigate. Nor, as it turns out, are we doing a good job of tracking how many have already had them, who is now eligible for them, or assuring that essential workers or disadvantaged populations are getting them. 

Amazon tells me when my purchases have shipped, where they are in the shipping process, and when they’ve been delivered.  They even send me a picture of purchases sitting on my porch to make sure I notice. Walmart’s supply chain management is equally vaunted. 

Health care executives evidently aren’t required to learn supply chain management. 

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You Can’t “Elon Musk” Healthcare

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By SOFIA NOORI

On January 26th, Philadelphia discovered that the 22-year-old organizer of its largest COVID-19 vaccination site, Andrei Doroshin, had turned away elderly members of the Philadelphia community from their vaccine appointments. Instead, he pocketed extra vaccine vials to administer to 4 friends and girlfriend. An RN witnessed the event and reported it to authorities. 

Local news reporters quickly discovered that this incident was just the tip of the iceberg for Doroshin. A Drexel University graduate student with no experience in healthcare, Doroshin had enlisted his college friends to organize a group that would go on to win one of the biggest vaccination contracts from the city of Philadelphia. He told his friends that “this is a wholly Elon Musk, shoot-for-the-heaven type of thing,” and that “we’re going to be millionaires.” His organization had also amended its privacy policy allowing for patient data to be sold, administered large numbers of vaccines to people ineligible to receive the vaccine yet, and threw Philadelphia’s COVID vaccination program into chaos. 

For the people in the back: One can’t simply “Elon Musk” healthcare. We have seen this too many times – a privileged young upstart with little experience believes that s/he can transform healthcare and make millions – or billions – doing so. Examples abound: we only have to look a couple years into the past to remember Elizabeth Holmes, the Stanford dropout who founded Theranos and misrepresented its technology, or to Outcome Health, whose former CEO Rishi Shah defrauded investors by overinflating business metrics. If “move fast and break things” works in other sectors, many reason, why won’t it work in the 4 trillion dollar industry of healthcare? 

Healthcare is simply not the kind of business where one can shoot a rocket into the sky and accept the risk that it might explode. Simply put, this is people’s lives we’re dealing with. But a deeper layer involves trust in the medical establishment. U.S. healthcare is already marred by multiple grave issues: a complex bureaucracy, serious health inequities, and astronomical costs that can bankrupt a person in just one hospitalization. The trust that people have in U.S. healthcare has steadily dropped over the years. Further, the politicization of the COVID-19 pandemic and the U.S. government’s bungled response to it has only sowed further distrust, especially among marginalized and minoritized communities. 

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