ACADEMIA Letters The COVID-19 Wars: Physician vs. Clinician Barbara Lewis, Brooklyn College of CUNY William Lewis, WashU, St. Louis (class of 2023) Introduction In his paper, Organizational Agility, Visionary Leadership in the Age of VUCA, HersheyFriedman uses the military idiom, VUCA, that has been adopted by the corporate world referencing the “vulnerability for obsolescence”: volatile, uncertain, complex, and ambiguous. Friedman depicts and cautions against this inflexibility found throughout most organizations, industries, and academic institutions that resist change and, therefore, face collapse. An analogous situation transpired during the global pandemic triggered by Covid-19. Author Susan Dominus in her New York Times Magazine article The Covid Drug Wars That Pitted Doctor v Doctor (8/8/2020), debates the dispute that emerged between the bedside physicians treating critically ill Covid-19 patients and the research clinicians. Their opposing perspectives on the morality of using treatments for which there is no evidence-based medicine (EBM) to confirm their efficacy, spawned battles. In this paper, we will draw comparisons between the rigid approach demanded by medical research protocols versus the agility needed to combat a pandemic, rapid in growth, “deadly, contagious and entirely novel” (Dominus). ”Fighting the Last War” “Warfare demonstrates the importance of using new approaches in fighting battles” (p. 26) states Friedman depicting several instances in which wars were fought with outmoded methods. From Waterloo muskets to the Crimean War rifles, improved firearm proficiency from Academia Letters, August 2021 ©2021 by the authors — Open Access — Distributed under CC BY 4.0 Corresponding Author: Barbara Lewis, barbaraj@brooklyn.cuny.edu Citation: Lewis, B., Lewis, W. (2021). The COVID-19 Wars: Physician vs. Clinician. Academia Letters, Article 3085. https://doi.org/10.20935/AL3085. 1 one hit in 469 to one hit in 16 (Friedman, p. 16 refers to White, 2012 p. 324). The technological growth in weapons was exponential between World War I and World War II so trenches and mustard gas below were ineffective whereas planes with bombs became the enemy above. This was an enemy undetected until the last moments and approximated a lightning-fast virus descending upon an unaware public. Dominus provides documentation for this viral Covid-19 war that she outlines which “pitted” physicians against one another. Covid-19 War: Agility and Instantaneous Responses Are Vital Considerably high mortality rates for hospitalized Covid-19 patients pressured physicians desperate for treatment options. Ideally, medications, even those approved to treat other illnesses (off label), would have been tested through RCTs (double-blinded, randomized, controlled trials meaning that neither the patient nor the doctor knows which test group they are in). Considered the standard in research, these tests prevent bias in judgement polluting results. But there was no time for this. The morgues were filled, and refrigerated trucks were parked in New York neighborhoods collecting bodies. Dominus relates an interaction between a research team member and a pulmonary-critical care doctor who judged his patient needed a higher dosage of the trial medication and, therefore, would be removed from the trial. Angry words were exchanged after which the lead researcher stated in a subsequent meeting that “Relying on gut instinct rather than evidence..[was] witchcraft” (Dominus, p. 2). That is the derivation of the infamous blow repeated in the Covid-19 research community. The outbreak was overwhelming to the health care system with a virus unknown and deadly. Global doctors sought information from social media platforms and WhatsApp groups to garner some understanding of treatment. Nothing was peer-reviewed because this novel virus was too new. A cardiologist in California was alarmed at how physicians in NY were treating patients using off-label treatments declaring, “it felt it wasn’t even World War I medicine…It was almost like civil War-level medicine, reported Dominus (p. 4). Constructing a timeline regarding the various drugs utilized and their benefit or risk to the patient, Dominus interviewed frustrated physicians who proclaimed, “There is no proof that anything works…Everything is experimental” (Dominus, p. 6). They were conducting guerrilla warfare without science to guide them. Another story transcribed by Dominus depicted the excited response to hydroxychloroquine, declared as a lifesaver but later revealed to create heart problems for some patients. Physicians were “panic-prescribing” (Dominus, p. 9) without any EBM. With the broad dispensing of hydroxychloroquine, there was no way to enroll subjects in an RCT as treatment Academia Letters, August 2021 ©2021 by the authors — Open Access — Distributed under CC BY 4.0 Corresponding Author: Barbara Lewis, barbaraj@brooklyn.cuny.edu Citation: Lewis, B., Lewis, W. (2021). The COVID-19 Wars: Physician vs. Clinician. Academia Letters, Article 3085. https://doi.org/10.20935/AL3085. 2 with this theoretical miracle drug because they began a protocol immediately upon verification of infection. In contrast, by June 2020, Britain had conducted a large RCT and found this drug was not a useful treatment. How was Britain able to do so while the US was stymied? In Britain, high-level medical officials sent messages throughout the country requesting that physicians not use off-label meds without an RCT in place, whereas in the US, federal agencies had done the opposite, easing restrictions regarding off-label usage in the panic to provide defenses to fight the pandemic. An NYU bioethicist acknowledged that “the commitment to long-shot efforts to rescue patients was stronger than the commitment to science” (Dominus, p. 11) thus delaying RCTs. More strife transpired regarding the aggressive use of anticoagulants, as well as corticosteroids, with the ethical dilemma of not providing enough of this class of drugs to some of the test subjects to prevent their deaths. The position of the bedside doctors as they were fighting the rapid onset of conditions that this disease generated, became “life and death. Fear. Ignorance. You were seeing human behavior in survival mode, a classic reaction to threat” (Dominus, p. 15). Responses This dire situation prompted experimentation with medicines and dosages that may be harmful to the patient but so is an RCT if the patient is in the control group and is receiving a placebo, not the medicine being tested, or a different dose of the existing medicine. Many physicians were practicing “kitchen sink therapeutics” (labeled by Griffin in TWIV episode 656) so that anything was attempted. But as the COVID-19 evolution of treatments reveals, some of the protocols did much harm rather than any good. Professionals were in clinical equipoise in that they did not know which treatment would be better for patients, but they were urgently seeking some approach to combat the flow of patients and deaths. The Stanford Encyclopedia in The Ethics of Clinical Research article by A. London, Social Value, Clinical Equipose, and Research in a Public Health Emergency, identifies the “fundamental ethical concern raised by clinical research is whether and when it can be acceptable to expose some individuals to risks and burdens for the benefit of others”. This was the trigger that set the two groups of Covid-treating physicians (those bedside and those researching the treatments for the virus) on the warpath with the battle cry of “witchcraft” leveled against doctors attempting any available treatment to prevent another death without having the certainty and guidance provided through EBM. Griffin (TWIV episode 656) labeled the interaction as skirmishing when a cease-fire was required. He describes an interaction directed at a steroid prescribing physician who was accused of “killing the patient.” Academia Letters, August 2021 ©2021 by the authors — Open Access — Distributed under CC BY 4.0 Corresponding Author: Barbara Lewis, barbaraj@brooklyn.cuny.edu Citation: Lewis, B., Lewis, W. (2021). The COVID-19 Wars: Physician vs. Clinician. Academia Letters, Article 3085. https://doi.org/10.20935/AL3085. 3 London projects that “testing potential new treatments can take 10-15 years” (London, p. 3). With a novel virus that grows exponentially globally and with mind-boggling rapidity, how can any testing get up and running quickly enough to benefit the millions battling the illness? Additionally, the article underscores a physician may not “compromise patients’ medical interests when conducting therapeutic studies” (London, p. 11). There are stringent regulations designed to protect the subjects, but the nature of these studies clearly places some in a more dangerous position with the philosophy that the study provides for the greater good rather than the individuals’ benefit. Is this immoral: placing some at risk, or not proceeding with studies and placing all future persons contracting the illness at risk? Is there an ethical delineation between actively causing harm versus allowing harm to occur? Although testing might not actively cause harm, it may reduce a subject’s ability to be cured, thus harm occurs. For Covid-19 treatment options, there has been little time to generate RCTs. Is it ethical to withhold a possible treatment if the patient is in the control group? Physicians need the science behind the treatment, but with a new novel virus, how do we create guidance while still addressing immediate and catastrophic patient needs? This is the “parachute” dilemma that D. Griffin discusses in his podcast See It Can Be Done (episode 656 TWIV). Withholding a medication may pose a serious ethical problem for the physician if their judgment is telling them that the medication is necessary. Yet administering it will remove the patient from the test subject pool. The concept of an RCT of a parachute led to the naming of this dilemma - the absurdity of designating a pool of randomized subjects who would consent to be in the placebo parachute users’ group dropping from a height without a parachute most likely guaranteeing death. Worrell warns of the “fetishization” of random testing and that sometimes it is not necessary and even detrimental (episode 656 TWIV). Conclusion The moral dilemma created by a new novel, fast-spreading, virus is unique in our present history with the last occurrence a century ago. Will we be fortunate to not face this again for another 100 years? Some scientists predict that these events will be arriving more frequently as we claim more of the earth from indigenous species and zoonotic diseases will continue to plague us. We need to prepare for these wars and have an agreement between treating physicians and research clinicians as to how to plan and test possible treatments. Friedman stresses adaptability and improvisation, testing multiple options simultaneously to deploy remedies more rapidly. Discord and clashes are counterproductive. The exchange of global information expedited by the internet, as it was during this pandemic, enables the world’s scientific community to conjoin and share information across borders. This should not be politically Academia Letters, August 2021 ©2021 by the authors — Open Access — Distributed under CC BY 4.0 Corresponding Author: Barbara Lewis, barbaraj@brooklyn.cuny.edu Citation: Lewis, B., Lewis, W. (2021). The COVID-19 Wars: Physician vs. Clinician. Academia Letters, Article 3085. https://doi.org/10.20935/AL3085. 4 motivated, as is war, but rather, a collaborative endeavor that will allow humans to cohabitate with indigenous life on our planet. References Dominus, S. (2020, August 8). The covid drug wars that pitted doctor v. doctor. New York Times Magazine. https://www.nytimes.com/2020/08/05/magazine/covid-drug-wars-doctors. html Fuller, J. (2020, January 6). Evidence based medicine. Philosophers on Medicine. https:// jonathanfuller.ca/podcast/2020/1/6/evidence-based-medicine Friedman, H. (2020, November 11). Organizational agility, visionary leadership in the age of VUCA. SSRN https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3728372 Griffith, D. (2020, August 23). Episode 656. See it can be done! This Week in Virology. podcast. https://www.microbe.tv/twiv/twiv-656/ Worrall, J. (2020, August 23). Evidence based medicine. Philosophers on Medicine. podcast https://www.microbe.tv/twiv/twiv-656/ London, A. J. (May 20, 2018). Social value, clinical equipoise, and research in a public health emergency. Clinical Research. Section IV. Stanford Encyclopedia. https://plato. stanford.edu/entries/clinical-research/ Academia Letters, August 2021 ©2021 by the authors — Open Access — Distributed under CC BY 4.0 Corresponding Author: Barbara Lewis, barbaraj@brooklyn.cuny.edu Citation: Lewis, B., Lewis, W. (2021). The COVID-19 Wars: Physician vs. Clinician. Academia Letters, Article 3085. https://doi.org/10.20935/AL3085. 5