One recent Friday night, we huddled with our colleagues in the pouring rain at a movie theater parking lot– our cars packed with supplies for our mobile vaccine clinic— trying to find someone who wanted an extra dose of Pfizer’s COVID-19 vaccine before it expired. Five months ago, we would have been inundated with people desperate for that extra dose. But that has changed now that the most willing and able segments of the population have largely been vaccinated.
Amidst this backdrop of slowing vaccination rates in the U.S. and many miles to go before reaching all of those willing to be vaccinated, the CDC has released updated recommendations for mask wearing that we believe to be premature and contrary to the ethic and mindset of public health. Buoyed by mounting evidence supporting the effectiveness of vaccines, the CDC— cheered by the Biden administration— gave fully vaccinated Americans the green light to ditch their masks. As fully vaccinated public health nurses who are as excited as anyone about the vaccines’ real-world effectiveness, we nonetheless find ourselves again asking: what are they thinking?
To be clear, we do not question the evidence showing that all COVID-19 vaccines currently approved in the U.S. are safe and effective. We also crave good news, hope, and allowing the bottom half of our faces to see the light of day. We have also appreciated the Biden administration’s commitment to “following the [biomedical] science” in pandemic policymaking. Our concerns lie with the timing of the recommendation; the lack of regard for social science demonstrating the importance of public policy in influencing community norms and human behavior; and the blatant disregard for health equity. That the nation’s preeminent public health institution has fallen prey to the individualistic mindset that typifies American society, as CDC director Dr. Rochelle Walensky stated herself on Sunday regarding this “science-driven individual assessment” of risk, is frustrating, to say the least.
Currently, only one-third of the U.S. has been fully vaccinated. The news media has been full of accounts of many sub-groups who stubbornly defend their right to refuse a COVID vaccine, but the majority of those in the U.S. who remain unvaccinated belong to communities that have been unable to access a vaccine due to difficulty navigating online appointment scheduling, inability to take time off of work, poorly translated informational resources, or being ineligible due to age restrictions or other medical contraindications. Universal mask-wearing has been a critical stopgap measure to protect these at-risk populations until the majority of Americans are vaccinated. The CDC’s recommendation is therefore not only premature: it sends the message to individuals and other governmental entities alike that we don’t need to care about our neighbors.
But these systems can be tuned to reflect and address key concerns.
What follows is a list of ten separable concerns, and responsive design strategies. The concept of separation of concerns in technology design offers a path to better health policy. Because each concern hardly interacts with the others, any of them can be left out of the design in order to prioritize more important outcomes. Together, all of them can maximize scientific benefit while enhancing social trust.
An inspector should be assured that a vaccine certificate was not tampered with and that it was issued to the presenter. This need not imply any privacy risk, or even need a network connection. One such method for authenticating vaccine credentials adds a human-recognizable and machine-readable face photo to a standard 2D barcode. It works with paper as well as mobile phone presentations.
The digital divide
For this concern, paper credentials have equity and privacy advantages. Equity, because paper is cheap and well understood. Privacy, because there is no expectation that a person must unlock and show a mobile phone. Digitally signed certificates that also include a photo, like #1 above, can be copied for convenience without risk of fraud.
Unlike medical meetings, rendering Beethoven’s Ninth Symphony isn’t easy on Zoom, so the local orchestra has been furloughed and their members work for Uber. The opera house wants to reopen, preferably before we reach the elusive herd immunity threshold. They mandate vaccinations for their artists, not least because the performers can keep their masks off. Should they extend this requirement to their patrons?
Vaccine passports, proof of immunity against SARS-CoV-2, to work, dine, fly or watch shows, are controversial. Opponents say they blithely disregard decency, are operationally onerous, and hurt liberty. Worryingly, they create a caste system, which wouldn’t be as concerning if based on just immunology. Such a two-tiered system could sadly mirror societal inequities because it’s the poor who may disproportionately be left unvaccinated. Supporters of vaccine passports further the very structural disadvantages they seek to end.
When arguments are too compelling they likely betray an obvious simplicity. Too often arguments against mandates assume they’d be a government fiat. The opponents recline on the country’s inherently liberal streak conjuring visions of rugged individuals fighting unelected bureaucrats. They say with undisguised pride “this isn’t who we are. We’re the US, not New Zealand. We can’t be controlled.”
This narrative is so tightly embedded in right-of-center discourse that it’s now folklore bordering on an Ayn Rand fairy tale. The narrative is nonsense. The state is too incompetent to either govern adeptly or tyrannize efficiently. Case-in-point: CDC’s easily forgeable paper vaccine certificate. If the state were serious about prying on people’s antibodies, it’d have made the immunosurveillance digital.
The obsession with big government should be antiquated. By censoring content, Facebook and Twitter showed that freedom can more efficiently be curtailed by the private sector. Bottom-up censorship is arguably more powerful than top-down censorship because it has buy-in from a segment of the market. It may very well be the private sector which demands vaccine passports, which begs two questions – why and why not?
Admit it: you’ve been following the story about the huge container ship stuck in the Suez Canal. It’s about the size of the Empire State building laid flat, and somehow ended up blocking one of the busiest waterways in the world.
As serious as this was for global shipping and all of us who depend on it, much hilarity ensued. Memes exploded, using this as a metaphor for almost everything, healthcare included. Once there started to be hope for getting the Ever Given free, people started new memes that it should be “put back.”
Well, I’m a sucker for a funny meme and a good metaphor too. Our healthcare system is that canal, and we’re the unfortunate ship. Only it doesn’t look like we’re getting unstuck anytime soon.
The Ever Given got stuck a week ago. It is one of the world’s largest container ships, but high winds, poor visibility (due to a dust storm), and, perhaps, human error caused things to go sidewise, literally. It got stuck on the banks. Over 300 other ships have been blocked as a result; alternative routes add several thousand miles to the trip, making it a tough choice between waiting/hoping and rerouting.
Confrontation is good. Governor Abbott’s “We are getting out of the business of telling people what they can and cannot do” was “Neanderthal thinking” as President Biden said. Insurrectionist Richard Bennett, whose feet sat on Speaker Pelosi’s desk two month’s ago, does need to cool his jets in jail awaiting trial. And states lagging in immunizing teachers, opening schools, and accelerating their vaccine efforts need to realize that they will be held accountable by voters in the near future.
That is surface turbulence, but quietly below the surface, there are other transformational forces underway fueled by pandemic accelerants.
How long would it have taken under normal circumstances to advance equitable access to broadband and tech devices for all students in America? A decade from now, would we have advanced teacher skills in long-distance learning to the degree we are now witnessing? And how many at-home workers will be willing to return to off-site offices in the near future?
These are just a few of the questions being considering as we return to “normal” or life under the “new-normal.” And while we are all doing our best to cope with the fear and worry that comes with change, most of our collective anxiety is now focused on economic security and jobs.
This past month we added 379,000 jobs. Sounds great, that’s if you ignore the fact that there remain 9.5 million fewer jobs in our economy compared to a year ago, or that first-time jobless claims rose last week. As former Federal Reserve economist Julia Coronado reported, “We’re still in a pandemic economy.”
“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.
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:
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.
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.
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.