Thyroid Cancer August 6, 2020 • By Dr. M Sara Rosenthal
On March 11, 2020, the WHO declared the novel Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), which causes the coronavirus disease 2019 (COVID-19) to be a global pandemic. The world watched the virus ravage Italy, which responded with a nation-wide lockdown resembling the plague years of medieval Europe. The United States began to see the same emerging pattern, and pre-emptively shut down its institutions and economy in an effort to “flatten the curve” and also preserve its healthcare system, which would collapse from the burden of cases and the shortage of PPE, hospital equipment and ICU beds. Due to an absence of testing and tracing – a gold standard for controlling an outbreak – evidence-based projections for the United States were a mass-casualty event of at least half a million dead Americans without extreme measures of mitigation: physical distancing.
As we approach July, more Americans are dead from COVID-19 than who died in World War 1 (over 126,000 as of this writing). Those deaths occurred in the short time frame of four months. We surpassed 9/11 casualties in March; we next surpassed combined casualties from 9/11, and the post-9/11 wars of Afghanistan and Iraq in March. We surpassed Vietnam War casualties in April, and reached 100,000 casualties in May. The United States is currently the most infected country with the worst response to the COVID-19 pandemic due to another virus: disinformation and science denialism in which sound public health policy is being rejected and refuted by both American leadership and a significant portion of the U.S. population. With its CDC in ruins (see The Lancet: https://doi.org/10.1016/S0140-6736(20)31140-5), functioning as an attenuated version of its former self, there is no public health expert currently in charge of COVID-19 at a national level, while individual states are making decisions that are heterogenous. Some states never actually shut down; some opened prematurely without following CDC guidelines. Basic public health principles we learned a century ago have become controversial, such as mask-wearing. Many Americans do not agree on common facts of the virus reported by health experts, medical journals, and the media. As a result, our COVID Fall is probably going to resemble our COVID Spring, as shut-downs may become necessary in states that were hit by the pandemic later in the year. This month, two super-spreader biohazard events – political rallies planned by the Trump re-election campaign — have been held in two states with surges, which have alarmed all public health experts, infectious disease experts and bioethicists. In fact, from the European perspective, the United States is now considered such a malign pandemic actor, it is banning Americans from entering EU countries to help control resurgence of outbreaks (see: https://www.nytimes.com/2020/06/26/world/europe/europe-us-travel-ban.html).
This COVID blog series tracks the specific ethical issues bioethicists were dealing with throughout the COVID Spring. In Part 1, “When in Rome”: American Healthcare Prepares for the Surge, I look at March 2020 (http://endocrineethicsblog.org/journal-of-the-covid-spring-part-1-march-2020-when-in-rome-american-healthcare-providers-prepare-for-the-surge/). In March, bioethicists were concerned with many difficult questions surrounding rationing.
In COVID Spring, Part 2, “New York State of Mind”: Ethics of Shut-Down and Harm Reductions, I look at April 2020 (http://endocrineethicsblog.org/journal-of-the-covid-spring-part-2-april-2020-new-york-state-of-mind-ethics-of-shutdown-and-harm-reductions/ ). Here I review the surge issues in New York City, the bioethics debates surrounding shelter-in-place and economic shut down. In this timeframe, the White House Coronavirus Task Force held daily briefings, and accurately predicted that with mitigation, between 100,000 and 240,000 Americans would die.
In COVID Spring Part 3, “American Carnage”: Covid and Health Disparities, I look at May 2020 (http://endocrineethicsblog.org/journal-of-the-covid-spring-part-3-may-2020-american-carnage-covid-and-health-disparities/). In May, it became clear that COVID-19 was decimating vulnerable populations such as nursing home residents and African Americans. The African American COVID story is about long-standing health disparities and systemic racism. Bioethicists were already discussing how racism was frankly infecting public policy decisions surrounding premature opening, and I discussed it in a May presentation (https://youtu.be/yOrTvTHrfUs). When George Floyd was killed May 25, it became the last straw as African Americans who felt uniquely vulnerable to COVID-19 in addition to daily systemic racism, took to the streets in protests that lasted over 20 days.
In COVID Spring, Part 4, “Juneteenth: Systemic Racism, Moral Awakening, and Tulsa”. I look at June 2020 (http://endocrineethicsblog.org/covid-spring-part-4-june-2020-juneteenth-systemic-racism-moral-awakening-and-tulsa/). In June, the bioethics community published a Statement about its stance on systemic racism in the field of bioethics as the protests continued, and Americans of all backgrounds and ethnicities awakened to the harsh truths the pandemic helped to lay bare. By the end of the month, the pandemic began to surge in states that refused to heed earlier public health warnings about premature opening: Texas, Florida and Arizona become the new hot spots, as hospitals reach capacity.
For a good Spring retrospective on where we are, see: https://www.nytimes.com/interactive/2020/us/coronavirus-spread.html?action=click&module=Spotlight&pgtype=Homepage
On June 1, protests and social unrest rock the country’s core, as almost every major city in the U.S. erupts with protests over three recent police killings of unarmed African Americans. The country pivots to debates over systemic racism and police reform in the wake of George Floyd’s death. The White House responds with authoritarianism tactics (: https://www.vox.com/2020/6/3/21279391/george-floyd-protests-military-donald-trump-mattis) that raise military ethics questions and his former Defense Secretary denounces him as a threat to the U.S. Constitution (See: https://www.theatlantic.com/politics/archive/2020/06/james-mattis-denounces-trump-protests-militarization/612640/.
The entire medical field, including bioethics discuss systemic racism as an underlying problem in medical training and academic medicine in general. For example, during the a virtual version of ENDO 2020 in June, an anti-racism vigil is held (See: https://endocrinenews.endocrine.org/endocrine-society-holds-anti-racism-vigil-during-endo-online-2020/ )
In the field of Bioethics, the Association of Bioethics Program Directors published a Statement on Violence, COVID, and Structural Racism in American Society: https://www.bioethicsdirectors.net/abpd-statement-on-violence-covid-and-structural-racism-in-american-society/
As Americans of all backgrounds come together to acknowledge the damage of systemic racism in all aspects of American life, the holiday, Juneteenth approaches, (https://www.juneteenth.com/history.htm), which is the day African Americans celebrate freedom. June is also the memorial month of the Tulsa Massacre (https://www.tulsahistory.org/exhibit/1921-tulsa-race-massacre/). In a questionable move, the Trump re-election campaign schedules the first rally for President Trump since early March to take place June 19 (or, Juneteenth) in Tulsa, Oklahoma while it was experiencing a marked increase in coronavirus cases and Covid-19 hospitalizations. The planned event was designed as an indoor rally in a venue that would seat roughly 19,000 people, in stark defiance of CDC guidance and public health experts’ warnings. Additionally, attendees would not be required to wear masks. Instead, they were required to sign a waiver that they wouldn’t sue the Trump Campaign if they got sick with Covid-19 from their attendance. The waiver stated the following: “By attending the Rally, you and any guests voluntarily assume all risks related to exposure to COVID-19 and agree not to hold Donald J. Trump for President, Inc…or any of their affiliates, directors, officers, employees, agents, contractors, or volunteers liable for any illness or injury” (see: https://www.cbsnews.com/news/trump-rally-waiver-tulsa-ok-coronavirus-wont-sue-covid-19/). This waiver did not constitute “informed consent” nor do legal experts consider it enforceable (https://www.reuters.com/article/us-usa-trump-waiver/trump-campaigns-waiver-wont-block-coronavirus-lawsuits-experts-idUSKBN23J2Z5). Although the prospect of a rally in Tulsa on Juneteenth was racially insensitive, the prospect of a super-spreader event that met the criteria of a biohazard was ethically egregious from a public health standpoint. Tulsa businesses and residents even sought a court order to restrict the rally, but it was struck down by the Oklahoma Supreme Court. (See: https://www.nbcnews.com/politics/2020-election/oklahoma-supreme-court-denies-legal-challenge-trump-rally-n1231564)
Ultimately, the rally was moved to June 20th, and only about 6000 people attended, but were mostly not social distancing or wearing masks. On June 23, another Trump rally was held in Arizona, as the state was going through a surge that was overwhelming hospitals. Another 3,000 people packed into a megachurch without masks, alarming public health experts.
As we near July, several states that had never properly closed down in March, and insisted on reopening early, are now experiencing the New York surges of April. The White House Task Force scheduled the first briefing in two months to discuss the surges, and when asked whether Trump campaign super-spreader events were wise, Vice President Pence said the event was the campaign’s “constitutional right”. As of today, the United States has over 2.5 million coronavirus cases, and over 126,000 Americans have died in four months.
By early May, the field of bioethics was debating the associated risks of shutdown versus re-opening, as various states began to get a better picture of the demographics associated with Covid-19 deaths. What was emerging was a familiar and alarming health disparities story in which Covid-19 was ravaging vulnerable populations such as nursing home residents, African Americans, immigrant worker populations – particularly those who worked in meat plants. – particularly bearing the brunt of outbreaks in meat-packing plants. The U.S. now had over 1 million cases of coronavirus and by May 8, 76,000 deaths. Of those who died, almost 60% were African American (see: https://www.washingtonpost.com/nation/2020/05/06/study-finds-that-disproportionately-black-counties-account-more-than-half-covid-19-cases-us-nearly-60-percent-deaths/). Meanwhile, one-third of all Covid-19 deaths were in nursing home residents (see: https://www.nytimes.com/interactive/2020/05/09/us/coronavirus-cases-nursing-homes-us.html). But even among nursing home residents, there were disproportionate racial disparities (https://www.nytimes.com/article/coronavirus-nursing-homes-racial-disparity.html).
Other vulnerable groups were mostly immigrant workers in meat-packing plants (https://www.washingtonpost.com/outlook/2020/05/22/immigrant-workers-have-born-brunt-covid-19-outbreaks-meatpacking-plants/), as well as prison populations. As the health disparities news emerged, it began to drive policy in the wrong direction. An article in The Atlantic analyzed that the Trump Administration was less concerned about the pandemic once it was clear that the deaths were targeting vulnerable Americans who were not part of his base of supporters. The article notes: “Once the disproportionate impact of the epidemic was revealed to the American political and financial elite, many began to regard the rising death toll less as a national emergency than as an inconvenience… The lives of workers at the front lines of the pandemic—such as meatpackers, transportation workers, and grocery clerks—have been deemed so worthless that legislators want to immunize their employers from liability even as they force them to work under unsafe conditions….” (See: https://www.theatlantic.com/ideas/archive/2020/05/americas-racial-contract-showing/611389/).
What was clear is that populations with more comorbidities such as hypertension and type 2 diabetes were at much higher risk of dying from Covid-19, while the social production of chronic health problems are more prevalent with economic disparities and poverty. It was also clear that our nursing home system was perilously unprepared and underfunded.
In the African American population, the health disparities story is a familiar pattern. It was becoming clear that Covid harkened back to inequities that came from centuries of institutionalized racism that led to the Tuskegee study, disproportionate HIV infections in African Americans by the 1990s, and the abandonment of less mobile African Americans in the wake of Hurricane Katrina. An African American New York Times journalist, Mara Gay, recovered from Covid, and wrote this:
“Why are more people dying of this disease in the United States than in anywhere else in the world? Because we live in a broken country, with a broken health care system. Because even though people of all races and backgrounds are suffering, the disease in the United States has hit black and brown and Indigenous people the hardest, and we are seen as expendable.” (See: https://www.nytimes.com/2020/05/14/opinion/coronavirus-young-people.html?action=click&module=Opinion&pgtype=Homepage).
All the while, conservative groups were fighting mitigation orders: several churches wanted to begin holding live services again, “anti-government” protestors marched outside of state legislatures, while mask-wearing became intensely political because American leadership was demonstrably against mask-wearing. For example, Vice President Pence would not wear a mask even when touring the Mayo clinic in April, and President Trump openly refused to wear a mask throughout May, even while touring a Ford plant in Michigan, which was retooling to make PPE and ventilators. See:https://www.washingtonpost.com/politics/2020/05/21/trumps-reason-not-wearing-mask-sticking-it-media and :https://www.forbes.com/sites/mattperez/2020/05/21/trump-refuses-to-wear-a-face-mask-during-tour-of-ford-facility-in-michigan/#5e92cfa658f7 .
Americans struggling with staying safe during the worst pandemic in over a century found themselves battling an unlikely culture war over masks. By May, mask-wearing becomes an exhausting education effort for healthcare providers. Consider this piece from a Reno physician May 18: https://www.rgj.com/story/news/2020/05/18/reno-er-doctor-wearing-mask-sacrifice-we-all-need-take/5215101002/.
Worse, not only do many Americans openly defy mask-wearing policies instituted by individual retailers, but they even begin to deny that Covid-19 is “real” as bizarre conspiracy theories about “inflated death tolls” begin to circulate on right wing social media sites (https://www.forbes.com/sites/mattperez/2020/05/10/death-toll-conspiracy-why-conservative-media-and-soon-possibly-trump-are-doubting-coronavirus-mortality-figures/#550f772a57d5).
This piece from the Washington Post encapsulates the “Covid denialism” and the divisiveness coursing through the country: https://www.nytimes.com/2020/05/15/opinion/coronavirus-democracy.html?action=click&module=Opinion&pgtype=Homepage&fbclid=IwAR15p5RtwV16JGneqBXZI-cRwGRfjpSf6zi2cq7nZgsI7hdWw9udPUcSJ5A
By May, the United States had signaled to the world that it was incapable of managing a pandemic and began to be pitied. See, for example: https://www.washingtonpost.com/opinions/the-united-states-is-a-country-to-be-pitied/2020/05/14/d2d98e9c-961e-11ea-91d7-cf4423d47683_story.html . In fact, the United States inability to handle the pandemic was turning into a national security problem as other countries watched in horror how easy it was to paralyze the United States by a virus: https://www.washingtonpost.com/national-security/plagued-by-disease-unemployment-and-outrage-at-the-police-america-plunges-into-crisis/2020/05/29/c8329bb2-a1b5-11ea-81bb-c2f70f01034b_story.html?fbclid=IwAR3diZl9dV7Es6XNpUpWNBcMc3kOnJUQeNRFiFvJpcpOfPeIMj4_yARdJck
By Memorial Day on May 25, we had reached the milestone of 100,000 deaths (see: https://www.washingtonpost.com/graphics/2020/national/100000-deaths-american-coronavirus/), and the New York Times listed the names of the first 10,000 victims of Covid-19 in a gripping front page: https://www.nytimes.com/interactive/2020/05/24/us/us-coronavirus-deaths-100000.html
That same day, George Floyd was killed by police in Minneapolis in a horrifying death caught on camera that lasted over 8 minutes in which he continuously states “I can’t breathe”. Although Floyd’s death was not Covid-related per se, at the same time, it had everything to do with the African American experiences with the respiratory symptoms of Covid-19, and the political moment of feeling unseen and ignored, and killed by the disease of racism. The beginning of a roughly 25-day protest and movement surrounding systemic racism would begin to unfold.
By April 1, the country had effectively shut down. New York City was in full surge, as healthcare providers around the country were following New York’s plight, including shortages of PPE and struggles to meet ICU resource demand. Several New York healthcare providers were journaling about their experiences, moral distress, and essentially combat fatigue (see, for example, https://www.nytimes.com/2020/04/14/magazine/coronavirus-er-doctor-diary-new-york-city.html ). For those who had missed the March 31st briefing about predicted death tolls, Americans woke up to headlines like this in the Washington Post: https://www.washingtonpost.com/world/2020/03/31/coronavirus-latest-news/?fbclid=IwAR23vUfNKjcFMUF2xdLqRapteWdrCOyqm_LO1SrAgPWkrDJ-9Sdsko4hk_E
In solidarity, “Flatten the Curve” became the mantra, as economic experts, public health experts and bioethicists began to openly debate the risks and harms of economic shutdown, job loss, and other consequences versus the casualties of opening up “blind” without adequate testing and tracing protocols in place. New York Governor, Andrew Cuomo’s daily briefings became a national leadership touchstone, and most governors began their own daily briefings by then. Although the first case of Covid-19 in New York City was detected March 1, by April, New York City’s casualties hit 1400; by April 15, New York City’s casualties hit 10,000 and continued to rise, evoking a crisis not seen in that city since 9/11. By the end of April, the city’s casualties hit 18,000, six times the casualties on 9/11.
The White House Task Force briefings continued through most of April. But when they clearly attracted a large viewership, the briefings had devolved into a daily spectacle as President Trump decided to usurp the airtime, playing a more central role in fielding the questions instead of the health experts. Many of the briefings dissembled into a de facto “Trump Rally”; frequently, they were vehicles to attack the press, contradict the facts, and promote unproven conspiracy theories, while Drs. Birx and Fauci would practice their best neutral faces as the President confused and gaslighted the public.
By April 3, after several public health experts provided evidence that mask-wearing reduced infection, the CDC reversed itself about masks. Initially, in an effort to ration PPE and prevent public stockpiling of medical masks, the agency did not recommend masks to the public for those who were not infected. In April, the CDC suggested the public should now consider wearing masks for protection. (https://www.npr.org/sections/coronavirus-live-updates/2020/04/03/826219824/president-trump-says-cdc-now-recommends-americans-wear-cloth-masks-in-public). However, when President Trump made clear that he would not wear a mask, while conservative media began to eschew it as a fear-based reaction and an infringement on civil liberties, this critical public health tool morphed into a partisan issue that persisted, helping to distinguish the United States as a failed state with respect to setting public health standards to combat the growing pandemic. By April 4th, this analysis laid bare that the U.S. was amidst a manmade disaster of coronavirus denialism that exacerbated our ability to deal with the pandemic: https://www.washingtonpost.com/national-security/2020/04/04/coronavirus-government-dysfunction/?arc404=true&fbclid=IwAR0eO-T-3a59CO1K3amu84ScvjYbUMaLd73ASym08l4T8Mi_6pm_ak8h10o
Meanwhile, President Trump was encouraging re-opening by Easter weekend 2020, wanting “packed churches” an aspiration completely untethered to reality. Nonetheless, he began tweeting to his base to protest in states with stay-at-home orders and encouraging them to resist mitigation (See: https://www.washingtonpost.com/lifestyle/style/that-ohio-protest-photo-looked-like-a-zombie-movie-zombie-movie-directors-think-so-too/2020/04/17/b518fc48-801c-11ea-9040-68981f488eed_story.html?fbclid=IwAR2Mzox_ynW6Nt3AI7lhpkplEQYisfH_QzEXln6owbcQo4HE3neDveU41OU). On April 23, during a White House Task Force briefing, President Trump actually suggested the American public might consider drinking or injecting bleach to combat Covid-19. (See: https://www.nytimes.com/2020/04/24/us/politics/trump-inject-disinfectant-bleach-coronavirus.html), while Deborah Birx barely contained a look of horror. At that juncture, the White House daily briefings ceased.
In April, we were in economic free-fall; hospitals were emptied of all non-emergent patients and facing serious budget shortfalls. Most endocrinologists established telehealth clinics, while many endocrine surgeons were home without cases.
By April 28, more Americans had died from Covid-19 than in the entire Vietnam War. (See: https://www.npr.org/sections/coronavirus-live-updates/2020/04/28/846701304/pandemic-death-toll-in-u-s-now-exceeds-vietnam-wars-u-s-fatalities. ) As Americans began to applaud their healthcare heroes and essential workers at their grocery stores, the country still remained without a clear plan for testing and tracing that would sound re-opening protocols; PPE was still a problem, an empty and shut down New York City looked like an apocalyptic dystopia, as the country realized it was “every State for itself” without a comprehensive national plan or strategy. Bioethicists by the end of April began to offer frameworks and ethical rationale for re-opening, balancing the harms of mitigation and shutdown itself. In a Hastings Center essay, bioethicists note: “…The question of when and how to reopen the nation is on everyone’s mind. Do we open quickly in an effort to kick-start the economy? Or do we remain under lockdown as long as possible to stop the spread of the virus? (See: https://www.thehastingscenter.org/when-to-reopen-the-nation-is-an-ethics-question-not-only-a-scientific-one/). For many, April 30 felt like “March 70th”, a slow-moving disaster.
For most of us, March feels like a blur. The last day of quasi-normalcy for me and my bioethics team at the University of Kentucky was March 11, 2020. The University of Kentucky had announced its first COVID-19 case on March 7, 2020, and our Governor, Andy Beshear, declared a state of emergency. UK Healthcare set up an Incident Command, and held a town hall meeting on Monday, March 9, 2020 fielding questions from healthcare providers who were beginning to panic – about personal protective equipment (PPE), quarantine issues, availability of testing, and whether to continue as usual. That afternoon, the Endocrine Society, for the first time in its history, cancelled its conference (see: https://www.magnetmail.net/actions/email_web_version.cfm?ep=XbhxMxoKOt-hJVO2DScV1H0SHN7SRsrPp8ldJNpY5STfUjqYyfqaAUx9PER-kEq_ATX9xG6wmXV2CfZvGXMSkdT_lheragRlZMbSk4qrb1uIP1odE6QYmRZIAcP0bqCr). It was the right thing to do, but punctuated the gravity of the moment. I could only imagine the organizational ethics angst in making that decision, and the financial costs involved for the Endocrine Society.
When I got the message from the President of the Endocrine Society, I was hosting a colleague from Case Western University, scheduled to give a talk on March 10th. As the Endocrine Society BOD was likely debating cancellation the weekend of March 7th, my colleague and I exchanged emails as to whether to cancel, but as he was driving and not flying, we decided to go forward as planned. We hosted him for dinner Monday, March 9, 2020 at a chic Lexington restaurant that was half-full. I glanced at my newsfeed and began reading the shocking news out of Italy; it they had gone to full lockdown and closed its borders, which seemed like something out the Middle Ages. As my colleague and I strolled from his hotel to the restaurant, I commented: “See – we’re still open for business – not like Italy yet…”. (At this point, parts of Seattle had already been shut down). We all were careful to wash our hands prior to sitting down. We discussed the inevitability of community spread across the U.S., and wondered aloud when things would change for us. On March 11th, my team bid my colleague farewell and safe travels home, and we made the decision to cancel our April and May bioethics events out of caution. I dusted off a 2009 “Pandemic Ethics Resource” I had written for our institution in preparation for H1N1, revised it based on COVID-19, and circulated it for review to our Hospital Ethics Committee. I began to plan for drafting specific COVID-19 ethics policies. On Thursday March 12th, when the NBA cancelled its season, and New York City shut down its restaurants, it was the signal to many who were holding out to cancel everything. And then an avalanche of cancellations and shut downs began across the country and academia: moving all classes online and into virtual spaces; cancellation of conference after conference.
On Friday, March 13, my husband (Dr. Kenneth Ain, a thyroid oncologist) and I kept reservations at a nice restaurant to celebrate a family birthday that night. I took a picture and posted it on Facebook, with the statement: “Our last dinner out for a long time. Before we peak”. It was the last time I was in a restaurant. That weekend, all stores were stripped of supplies like toilet paper, hand sanitizer, and cleaning products, as we stocked up for three months.
The week of March 16th, healthcare institutions across the country set up incident commands, while governors in several states issued states of emergency and executive orders to brace for impact: build hospital capacity by cancelling elective procedures, and begin to ration PPE because nobody had enough to go around for a coming pandemic. Several states, including ours, also closed all non-essential businesses and issued stay at home orders. What was driving these decisions were projections that we needed to severely social distance based on reports. (See: https://www.nytimes.com/2020/03/16/us/coronavirus-fatality-rate-white-house.html?action=click&module=Spotlight&pgtype=Homepage&fbclid=IwAR3YAY2PA5KmSmM1YvajL7HS6w5g37x4OBjtYnyNx7YbAibBaPhWYAN2w_M)
Prior to that week, the term “PPE” was not a commonly known term for the general public. As for testing, it needed a rationing protocol as well. Finally, as American healthcare providers began to read about the Italian experience with ICU rationing, every clinical ethicist in the U.S. began to draft or share “Crisis Standards of Care” triage and rationing protocols designed specifically for COVID-19. As of mid-March, accurate data surrounding the exact risks to healthcare workers were unclear, but the experiences based on China and Italy suggested that 20-30% of exposed healthcare workers were becoming infected. There were three significant pieces of COVID-19 medical news that informed most of our decisions in March: (1) an Anonymous healthcare provider wrote a warning to the cavalier Americans, published in Newsweek (see: https://www.newsweek.com/young-unafraid-coronavirus-pandemic-good-you-now-stop-killing-people-opinion-1491797); (2) a JAMA interview with an Italian ICU physician, entitled “Coronavirus in Italy – Report from the Front Lines” (see: https://www.youtube.com/watch?v=TKS1pahoPRU); and (3) the Italian Society for Anesthesia Analgesia Resuscitation and Intensive Care (SIAARTI) released its newly drafted triage guidelines. See: http://www.siaarti.it/SiteAssets/News/COVID19%20-%20documenti%20SIAARTI/SIAARTI%20-%20Covid-19%20-%20Clinical%20Ethics%20Reccomendations.pdf
The Italian guidelines were alarming because they suggested rationing ICU resources based on age. But by the end of March, a shortage of testing, tracing, and PPE was a real game changer, and U.S. hospitals in surge areas were in dire need of functional triage protocols. Indeed, COVID-19 presented unique and new challenges for U.S. hospitals, and many tasked their clinical ethicists with drafting specific COVID-19 rationing protocols that had new considerations for this particular pandemic, including the risks of performing CPR.
In the context of the U.S., healthcare stakeholders were facing a total collapse of an already inequitable and dysfunctional healthcare system and a death toll of over 1 million citizens. At that time, the “bioethics” calculation of shut down favored expanding hospital capacity; triaging based on sound ethical frameworks, and saving lives. Shut down was a mitigation of last resort.
It seemed that clinical ethicists were all sharing one giant nationwide “reactive consult” that needed our attention. Healthcare providers began to report high levels of moral distress and moral injury, and several clinical ethics, mental health and spiritual care providers began to deal with a deluge of healthcare provider distress calls. By March 30, the number of Americans who had died from COVID-19 reached the same number as Americans who were killed on 9/11, yet there were still states that had not called for shut downs and stay at home orders. The following column appeared in the New York Times: https://www.nytimes.com/2020/03/30/opinion/republicans-science-coronavirus.html?action=click&module=Opinion&pgtype=Homepage&fbclid=IwAR3qxm4VokhV7am4fBwPRbt3DVtd-ogycaOOUR4R2aDQ4uLTcJKa-dcMMi8
On March 31, the White House Coronavirus Task Force, which began daily briefings in mid-March, soberly projected that between 100,000-240,000 Americans would likely die even with strict mitigation efforts of shutdown to flatten the curve; without mitigation, the number would be over 1 million Americans dead. The White House based its projections on an evidenced-based British study by the Imperial College of Medicine that demonstrated the need for mitigation through shut down was the only defense in the absence of any other tool (see: https://www.imperial.ac.uk/media/imperial-college/medicine/sph/ide/gida-fellowships/Imperial-College-COVID19-NPI-modelling-16-03-2020.pdf ). Additionally, the University of Washington’s Institute for Health Metrics and Evaluation (IHME) provided similar predictions (see: http://www.healthdata.org/covid/updates).
As March began, many Americans were already affected by travel advisories, stories of stranded cruise ships, and were preparing to see isolated pockets of outbreaks, such as the early cases in Seattle. By March 31st, the country was transformed, and “3/11” – the day the WHO declared the pandemic — was the marker between the pre-COVID and post-COVID world as we braced for the wave that hit Italy.
2019 marked a number of 50th anniversaries in the field of bioethics. Two of the biggest bioethics anniversaries included the 50th anniversary of Elizabeth Kubler-Ross’ On Death and Dying, which laid the groundwork for all end of life discussions and care delivered today (see: https://www.tandfonline.com/eprint/UYRGE3RPJPEKCDNHSIET/full?target=10.1080/15265161.2019.1674410)
Another major 50th anniversary was the founding of The Hastings Center (see: https://www.thehastingscenter.org/who-we-are/), which was the first bioethics think tank that began to publish and articulate important concepts for bioethics, and eventually led the field into various subspecializations, such as transplant ethics, research ethics or pediatric ethics – in which practitioners and scholars began to formulate applied ethical frameworks for particular fields. Similarly, Endocrine Ethics is a new subspecialization (see further).
The American Journal of Bioethics listed the top 10 bioethics stories of the years here (see: http://www.bioethics.net/2019/12/top-ten-bioethics-stories-of-2019/), many of which directly affect the practice of endocrinology, including the sweeping abortion restrictions that are now affecting the practice of reproductive endocrinologists who may have to rethink more preventative strategies, such as aggressive counseling about hormonal contraception, and creating greater restrictions regarding fertility treatment and the creation of high risk pregnancies that may not be allowed to be terminated in multiple states. The American Society of Reproductive Medicine strongly opposes so-called “personhood” laws that frame these new restrictions (see: https://www.asrm.org/about-us/media-and-public-affairs/public-affairs/asrm-position-statement-on-personhood-measures/).
Notwithstanding, the biggest Endocrine Ethics story of the year is also its oldest – access to insulin.The New England Journal of Medicine covered this story in November 2019 (see: https://www.nejm.org/doi/full/10.1056/NEJMp1909402), which is really more about the failings of the American healthcare system (which practices “healthism” and “wealthcare”) than it is about a diabetes crisis. The crisis is from the high cost of insulin leading to the rationing of insulin, which has put thousands of insulin-dependent diabetes patients at risk of dying from a disease we’ve been able to treat since 1921. In fact, access to insulin was one of the first uniquely endocrine ethics issues that emerged in the 20th century, and it seems we’ve come full circle. The precedent set by the co-discoverers of insulin (a wild research ethics story in its own right) of making insulin widely accessible by selling the patent for $1 to the University of Toronto, led to widespread accessibility of other wonder drugs years later, including the polio vaccine.
Other endocrine ethics stories dominating the news include the continuing controversies over treating well-differentiated thyroid cancers and Graves’ disease and a concerning spread of disinformation surrounding so-called “risks” of radioactive iodine that are unsubstantiated (see, for example: http://am2016.aace.com/presentations/thursday/T22%20&%20T53/ain_radioiodine_remnant_%20ablation.pdf). This has led to disparate standards of care, and many seasoned thyroidologists’ warning of the coming tsunami of patients who will present with iodine non-avid thyroid cancers because of the withholding of the standard of care.
Finally — as you can see, Endocrine Ethics Blog was a little less active in 2019 than in previous years, but that’s because one of the biggest Endocrine Ethics stories this year involved me: I founded in October 2019, along with three other colleagues, the first professional society for endocrine ethics issues: The Endocrine Ethics Association (see: www.endocrineethics.org). You will hear more about this organization in conjunction with this year’s Endocrine Society Meeting in March 2020.
In 2020, here’s to solving the insulin crisis so that thousands of insulin-dependent diabetes patients can see clearly for as long as possible.
This month, the most restrictive abortion ban in American history, known as the Human Life Protection Act, was passed in Alabama, which has led to a tsunami of similar laws throughout the South and mid-west (see: https://www.nytimes.com/2019/05/15/us/abortion-laws-2019.html?module=inline. Missouri also passed a controversial bill this month that bans abortion beyond 8 weeks (see: https://www.nytimes.com/2019/05/24/us/missouri-abortion-law.html).
The Alabama law makes it a crime for doctors to perform abortions at any stage of a pregnancy unless a woman’s life is threatened or there is a lethal fetal anomaly (see: https://www.al.com/news/2019/05/alabama-abortion-ban-passes-read-the-bill.html). Doctors in Alabama who violate the new law may be imprisoned up to 99 years if convicted, but the woman seeking or having an abortion would not be held criminally liable. Thus, Alabama’s law severely punishes healthcare providers for terminating pregnancies for any reason unless the patient’s life is threatened, effectively forcing them into wrenching ethical dilemmas and moral distress, and upending common practices in fertility treatment care. The law – which is unethical, clearly violating the Principle of Respect for Autonomy — has effectively left reproductive healthcare in the “fetal position” as such a law will make abortion in Alabama in 2020 – in post-Roe America more restrictive than it was in 1920 – in pre-Roe America. The American Society for Reproductive Medicine has made clear that it opposes the Alabama fetal “personhood” law (see: https://www.asrm.org/about-us/media-and-public-affairs/public-affairs/asrm-position-statement-on-personhood-measures/ ).
Even in pre-Roe America, when abortion was illegal by the mid-19th century, it was always legal for physicians to perform a therapeutic abortion. The definition of “therapeutic abortion” was never clearly defined and was always left up to medical judgement to define. Typically, psychological and psychosocial harms from an unwanted pregnancy would be frequently considered. Between the 1920s and late 1930s, women could access safe abortions from a number of physicians in urban centers. Even later in pre-Roe America (1940s-1973) when abortions became more restrictive and cost-prohibitive, hospitals had therapeutic abortion committees that took psychological and psychosocial harms from an unwanted pregnancy into consideration.
In my own state of Kentucky, abortion was effectively banned in March through two bills: one bill prohibits abortion after six weeks (most women don’t discover they are pregnant prior to six weeks); the other bill prohibits abortion if it’s related to results of fetal diagnosis. The ACLU challenged both laws shortly after passage in federal court arguing it is unconstitutional (See: https://www.aclu.org/blog/reproductive-freedom/abortion/kentucky-just-banned-abortion?fbclid=IwAR17UypgeafdMW-_mYCgPxpt1RkalH1y-xGhJJkjgWQgAs7yu99VxnwtPGA). On March 27, 2019 a judge ordered the laws be suspended indefinitely until the court issues a final ruling on whether they are constitutional.
But the Alabama law is the new crystal ball for the future of abortion in the U.S. It’s clear that Roe v. Wade has become irrelevant in a post-Casey America. In the 1992 Casey decision, the court clarified that the states could place restrictions on abortion previability so long as it was not an “undue burden”, which led to Targeted Restrictions for Abortion Providers, or TRAP laws.
It is likely that by 2024, the country will be divided into a reproductive justice system of “free states” and “TRAP states” – where poor women are enslaved by their biology, as well as lack of access to hormonal contraception. We all know that abortion access is never a problem for the wealthy and well-connected who can travel out of state or to another country. Unwanted pregnancy is not just about the consequences of unprotected sex, but of classism and health disparities.
This year is the 50th anniversary of Norma McCorvey’s quest for an abortion in Texas when she was 21, when roughly 10,000 women per year in the U.S. were dying from unsafe abortions. She went to attorneys Linda Coffee and Sarah Weddington, who renamed her “Jane Roe”, and challenged the Dallas District Attorney, Henry Wade. The following year, in 1970, the District court ruled in favor of Roe, stating the Texas law was unconstitutional, but wouldn’t grant an injunction against the law; this eventually led to the Supreme Court decision of Roe v. Wade. By then, Norma had already given birth and put the baby up for adoption. 50 years later we’ve come full circle.
A “Special Article”, recently published in THYROID, tells the story of what happens when unsubstantiated clinical practice guidelines for thyroid cancer are promoted as optimal care.
When the most recent revised thyroid nodule and thyroid cancer clinical practice guidelines were published by the ATA in 2015 (see: https://www.liebertpub.com/doi/pdf/10.1089/thy.2015.0020), the document remained at odds with the scientific consensus over the state of knowledge and previous standards of care. These guidelines made several sweeping recommendations without sufficient scientific or ethical justification (See: https://www.futuremedicine.com/doi/abs/10.2217/ije-2015-0010 and https://www.futuremedicine.com/doi/abs/10.2217/ije-2017-0008). The document also disclosed overt financial conflicts of interests by several of the authors, raising questions about whether some recommendations were influenced by authors’ industry ties. The fallout within the community of experts led to considerable moral distress amongst dissenting practitioners who felt they had beneficence-based duties to treat, but whose voices were marginalized. Indeed, thyroid cancer content presented at conferences in the post-2015 guideline years basically regurgitated the Haugen et al. (2015) recommendations as though they were partisan talking points.
The most questionable departure from traditional thyroid oncology practice were recommendations against the diagnostic or therapeutic use of radioactive iodine, as well as recommendations against total thyroidectomy in patients whose tumors were as large as 4 cm – what some surgeons and thyroid oncologists would consider egregious. The guidelines also encouraged observation of “low risk” tumors (although I have argued elsewhere that such practice should be regarded as experimental, and violates the Belmont Report if it is not presented in a research context). No treatment, undertreatment and questionable disclosure to patients became the new paradigm in thyroid cancer care. Many of the recommendations were based on pet theories and biases of some of the authors, relying on highly flawed or ethically questionable studies to support them. Of note, the nuclear medicine community refused to endorse the guidelines, which was unprecedented.
This month, in a stunning rebuke by Luster et al. entitled “European Perspective on 2015 ATA Management Guidelines for Adult patients with thyroid Nodules and DTC”, European experts called for revisions to approximately one-thirdof the ATA’s 101 recommendations in its 2015 document. (See: https://www.liebertpub.com/doi/abs/10.1089/thy.2017.0129.)
They stated the following in their abstract:
“Divergent viewpoints were the focus of an invited symposium organized by the European Association of Nuclear Medicine involving 17 European thyroidologists, four ATA Guidelines Taskforce members, and an audience of 200 international experts. The group discussed the preoperative assessment of thyroid nodules, surgery and the role of pathology, radioiodine (RAI) therapy (RAIT), the assessment of initial therapy and dynamic risk stratification, and the treatment of persistent disease, recurrences, and advanced thyroid cancer. The dialogue resulted in this position paper contrasting European and ATA 2015 perspectives on key issues. One difference pertains to the permissiveness of ATA 2015 regarding lobectomy for primary tumors ≤4 cm. European panelists cited preclusion of RAIT, potential need for completion thyroidectomy, frequent inability to avoid chronic thyroid hormone replacement, and limitations of supportive evidence as arguments against widely applying lobectomy. Significant divergence involved ATA 2015’s guidance regarding RAIT. European panelists favored wider use of postoperative RAIT than does ATA 2015. …European panelists suggested modifications to approximately one-third of ATA 2015 recommendations.”
Facts can be a stubborn thing.
The biggest bioethics story of the year, topping off the 200thanniversary of the publication of Frankenstein (see: https://frankenstein2018.com) was the announcement by Dr. He Jiankui on November 25ththat he had just created the world’s first genetically modified babies using the gene editing tool known as CRISPR cas9. He announced this at the 2ndinternational gene summit (see: http://www.nationalacademies.org/gene-editing/2nd_summit/index.htm); the story officially broke in MIT Technology Review (see: https://www.technologyreview.com/s/612458/exclusive-chinese-scientists-are-creating-crispr-babies/).
I also discussed this case earlier this month on a University of Kentucky podcast (http://uknow.uky.edu/research/ethics-crispr-twins-week-behind-blue)
What did He do?
Dr. He claims to have eliminated the gene that makes us susceptible to HIV in an effort to create HIV-resistant babies since the father is HIV-positive. (The gene is called CCR5). He also claims to have created another pregnancy which is still in the early stages.
This was a staggering announcement because it means Dr. He reportedly edited human embryos that were implanted back into the mother. This is called human germline editing – also known as human germline engineering. Human germline editing involves changing the DNA of sperm, eggs or embryos – which is passed down through generations, and which have unknown consequences to the human genome overall. Essentially, Dr. He may have changed the human DNA sequence for generations to come by creating a heritable mutation and genetically modified descendants. The babies in question are called Lulu and Nana (pseudonyms); when they grow up and have children of their own, they will pass on this changed DNA sequence to their children, who will pass it on their grandchildren. This could affect untold thousands of people in the future. Nobody knows the consequences of the mutation Dr. He has introduced – it could have altered the genome in significant and negative ways.
Several scientific peers have raised serious questions:
Ultimately, every bioethicist around the world has called this research completely unethical, including over 100 Chinese scientists who have stepped forward. Dr. He also violated an international moratorium on creating live births with human germline editing. In December 2015, the first international summit on gene editing took place in which the scientific community agreed that while research on human germline editing could be done on discarded embryos– so we could study and learn more about this — it could not be used to create live births because it was years away from practical application. In fact, I discussed this moratorium in December 2015 (see: http://endocrineethicsblog.org/editing-ourselves-2015-and-crispr/).
Creating live births using germline editing is illegal in several countries, including the UK and Canada. China has now declared this illegal, too. In the U.S., federal funds cannot be used for intentionally creating a human embryo that is edited or modified.
The bioethics consensus is that until sufficient public debate surrounding the ELSI consequences – the ethical, legal and social implications — of human germline editing takes place, this research is not only premature, but may not even be an acceptable scientific pursuit.
In a year where ethics violations in government without “checks and balances” have dominated the news, it seems the science news was no exception. The CRISPR twin research violated the Nuremberg Code, the Declaration of Helsinki and the Belmont Report.
Although some bioethicists question if we should respond to what “He Says” in the absence of any data, if someone is even claiming to have altered the human genome, science must provide a strong and swift rebuke. Because the last thing we want is (ahem) a copycat.