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.
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.
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.
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 andminoritized communities.
In March of 2020, when we had limited knowledge on the infectivity and virulence of the virus that causes COVID-19, I joined a team of critical care nurses who were willing to risk their lives to care for those suffering from COVID-19. As a full-time PhD student in nursing, a new parent to my infant son, a primary caregiver to my 73-year-old mother, and as someone with a known history of severe asthma, I knew that I was embarking on a journey that could potentially cost me my professional and personal dreams and endanger those I care for the most in life: my family. My intentions to practice only part-time as a critical care nurse while pursuing full-time studies were halted after only two weeks of managing critically ill COVID-19 patients early in the pandemic. The countless code blues and unprecedented levels of patient deaths made it clear that we were in uncharted territory. After seeing the pain and fear on the faces of my nursing peers, I knew I could never leave them behind in this new battlefield. So, I stayed at bedside full-time for a year while also maintaining my full-time status as a PhD student. I had to. I could not turn my back on my practice oath, or my future professional goals as a nurse scientist. It is in this spirit that, on behalf of myself and my exhausted colleagues, I call on those with critical care experience who have stepped away from bedside to return, as they are able, and answer this same call to action.
The extent of the critical care nursing shortage we are currently experiencing is alarming to me and almost beyond my comprehension. This shortage has forced critical care nurses who have been at bedside since March of last year to remain at bedside even as several of us have reached the breaking point of psychological exhaustion. Our desperate outcry for backup from our fellow critical care nurse colleagues seems to have yielded no outcome. It is obvious that addressing this shortage would require a solution with immediate implementation as we do not have time for the training of more critical care nurses. Thus, an immediate call to all nurse anesthesia students to return to bedside should be a part of any strategy geared towards quickly addressing issues of this critical care nursing shortage.
At a time when the role of critical care registered nurses is most needed, several nurse anesthesia programs continue with their regular admission cycle protocol: pulling critical care nurses away from bedside. At my current hospital, we lost nearly a dozen critical care nurse colleagues to nurse anesthesia programs between March and May of 2020 at the peak of the pandemic. Since the nurse anesthesia program requirements stipulate a minimum of one year of critical care nursing experience, all program applicants possess highly specialized clinical skills needed for the care of critically ill COVID-19 patients. While there are unarguable reasons as to why some nurse anesthesia students have yet to answer this urgent call to duty, we as a profession, and as a society must do what we can to incentivize them to return to bedside to help relieve the suffering of patients and exhausted nurses who have fought tirelessly at the frontlines since the onset of the pandemic – many of whom have lost their lives as a result.
Covid 19 vaccine development may have mainstreamed questions about how to hasten drug development timelines, but Medable, a health tech startup that offers researchers a way to de-centralize clinical trials, has been working to solve this problem for five years. Freshly funded with a $91M Series C raise, co-founder and CEO Michelle Longmire talks through the benefits of “liberating” clinical trials from academic research centers and sending them onto devices into patient’s homes. Traditionally, drug development processes average more than 10 years, cost millions of dollars, and are limited in the diversity of patients they can recruit because of the heavy focus on the geographic location of the research team conducting the trial. Medable’s digital platform breaks these limitations, reducing drug development timelines and costs by making it easier for researchers to draw study participants from anywhere. More importantly, it makes the novel medicines being tested by the trial available to a bigger, more diverse array of patients. Despite the gains made in 2020 toward the de-centralized clinical trial model (Medable’s revenue shot up 500%), there’s concern that Big Pharma may return to the business processes of old once the pandemic is under control. Does Michelle think last year make enough of an impact to change their business model for good? Find out what’s ahead for the future of pharma.