Core bioethical principles and the ethics of continued care during the COVID-19 war

Reflections on how bioethical principles and an analogy to wartime profiteering and privacy apply to continuing non-urgent fertility treatments despite current ASRM COVID-19 recommendations.

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Authors:

Shruti Agarwal, D.O., Rachel Booth, D.O., Jody Lyneé Madeira, J.D., Ph.D., Mark P. Trolice M.D., John Petrozza, M.D., Steven R. Lindheim, M.D., M.M.M.

Abstract:

Global leaders have increasingly used war rhetoric to describe the COVID-19 pandemic and are responding by prioritizing the rationing of care and essential resources. Unethical behaviors such as profiteering and piracy have characterized prior wartime conduct, with negative repercussions afterwards. Some fertility clinics are overlooking ASRM COVID0-19 recommendations, making it crucial to explore the bioethics perspectives on this decision. 

 

 

The World Health Organization (WHO) defines a pandemic as the worldwide spread of a new disease. This term was last used in association with the H1N1 outbreak of 2009.1 On March 11, 2020, WHO declared the novel COVID-19 (coronavirus) a global pandemic with over 118,000 cases in 114 countries.2 On April 2, 2020, coronavirus cases crossed 1 million worldwide as reported by Johns Hopkins University.3 The WHO was informed of this pneumonia-like illness originating from the city of Wuhan, Hubei province, China in December 2019.4 This virus has invaded all territories, heeding no boundaries and striking all regardless of age, gender, and race.

The initial impacts of COVID-19 on the medical community involved patient volume that overwhelmed hospitals, medical staff, and the availability of protective gear, causing clinicians to ration N-95 respirator masks and reuse masks designed for single use. While in-patient volume has caused a shortage of ventilators and hospital beds (particularly in ICUs), healthcare workers are falling ill and becoming unable to work.5  Given there are no current known pharmaceutical interventions, the WHO has implemented policies of social distancing, rigorous hand hygiene, and restrictions on travel, education, businesses and public events to reduce transmission.6 Furthermore, COVID-19 has had enormous economic impact worldwide, with the ten largest economies in the world at risk of slipping into a recession.7

In confronting this pandemic, world leaders have used war rhetoric to communicate the severity of the COVID-19 public health crisis. U.S. President Donald Trump has labeled himself as a “wartime president,” calling COVID-19 the “invisible enemy.”8 Chinese President Xi Jinping refers to efforts to fight against coronavirus as “the people’s war,” further defining the Hubei Province and Beijing as the two “battlegrounds.”9 French President Emmanuel Macron has also declared that his country is “at war” with COVID-19. Before his own admission to the ICU due to the virus, British Prime Minister Boris Johnson declared every citizen was “directly enlisted”10 in the war against COVID-19. Finally, Italian Special Commissioner Domenico Arcuri called for the country to prepare for a “war economy.”11

Certainly, a pandemic is not a perfect comparison to war as some ethicists have claimed; however, both carry many similar indirect consequences. Both invariably cause declines in basic necessities, disrupt everyday routines, and create unexpected crises. Products in high demand, including toilet papers and disinfecting wipes are now rationed, like scarce goods are in times of war.12  From a medical perspective, critical items, including facemasks, protective gear, and ventilators, are at exponentially low levels, potentially triggering a tipping point in ravaged areas where doctors may have to decide who merits life-saving care, and who they cannot save. Although President Trump has invoked the Defense Production Act, a law that allows the federal government to force production of essential equipment, many have called upon him to compel manufacturers to produce ventilators and other medical equipment—but, to date, he has been reluctant to take this step.13

War also brings about behaviors that many consider morally and ethically problematic, where individuals or groups try to either “profit” or “pirate” from limited supplies through price gouging and exploiting  the desperation of others. While profiteering refers to the practice of selling essential goods during an emergency for unreasonable sums of money,14 piracy involves unlawful accessing resources to which one has no claim.15

With respect to profiteering, COVID-19 has encouraged some bad behaviors, where high-demand products have tripled as the disease spreads throughout the United States and worldwide. Fortunately, retailers such as Amazon, have taken steps such as banning sales of certain necessities at inflated prices. States such as New York and New Jersey have paid exorbitant prices: ventilators priced at $40,000 that retail for $25,00016; a portable x-ray machine costing $248,841 that usually sells for $30,000 to $80,000, masks that cost more than 15 times the usual price, and infusion pumps sold for twice the going rate. 17

With all its negative connotations, war profiteering—gaining unreasonable profits from selling weapons or other products to parties in conflict—has existed as long as war itself. During the Civil War, “bounty jumpers” were substitute soldiers who enlisted for money but abandoned their fellow soldiers before reaching the front lines.  Franklin Roosevelt said during the World War I campaign, “I don’t want to see a single war millionaire created in the United States as a result of this world disaster.” Harry Truman deemed some forms of war profiteering treason. Nonetheless, World War I produced $28.5 billion in net profits and created 22,000 billionaires. World War II doubled these figures, with a net profit of $56 billion. During World War II, sellers hoarded sugar and coffee with the intent to profit from the paucity of these goods.18

Unlike war profiteering, war pirating has historically been considered acceptable. In the 1500s, England’s Queen Elizabeth I sanctioned pirates to legally engage Spanish ships in warfare to steal Spanish gold.19 During the American Revolution, pirates seized firearms, gunpowder, ammunition, and other goods for the government in return for profit shares.20 During the Civil War, Confederate President Jefferson Davis used pirates to attack Union ships and bring supplies across blockades.21 Recently, President Trump was  accused by Germany and France of “modern pirating” for allegedly diverting a shipment of medical masks bound for Europe and for outbidding other countries, and states, for medical equipment.22

Can terms such as profiteering and pirating be applied to businesses that remain open, ignoring recommendations to close? Such an action funnels customers—and their money—into accounts that would otherwise see no income and draws customers from other compliant businesses. Even if such conduct doesn’t fit conventional profiteering or pirating behavior, it may be unethical and dangerous.

ASRM’s New Guidance on Fertility Care during COVID-19 Pandemic, initially published on March 17, 2020,23 recommended suspension of new treatment cycles, including in-vitro fertilization (IVF), intrauterine insemination (IUI) and non-urgent gamete preservation. Urgent treatments, such as oocyte cryopreservation prior to impending gonadotoxic therapy and extirpative reproductive surgery, could continue. ASRM also strongly cautioned against initiating fresh or frozen embryo transfers, as the short and long-term effects of COVID-19 on pregnancy and fetuses remain unknown at this time. Coronavirus and associated Severe Acute Respiratory Distress Syndrome have been associated with preterm delivery, intrauterine growth restriction, and spontaneous miscarriage.24 ASRM also recommended minimizing in-person interactions and increasing the use of telehealth to help preserve dwindling resources and personal protective equipment.23

The national REI community’s response to ASRM’s guidance has been mixed; one vocal faction is arguing that infertility is not elective and that patient care should not be halted, while the other supports this guidance. Perhaps clinics performing elective, non-urgent treatments oppose recommendations to spare patients anguish, or to ensure the continued economic well-being of staff and management. Is it unethical for fertility clinics to continue IVF cycles and treatments despite ASRM’s recommendations, under the guise of protecting patient autonomy? What about if clinics employ aggressive risk management techniques, such as enforcing low patient volume and social distancing? What about the ethics of using medical resources, such as masks, gloves, sterile wipes, and other products that hospital clinicians are literally dying to obtain? Finally, how does one evaluate infertility treatment alongside other reproductive health procedures such as abortion services, which most states have recognized essential and emergent?25

Electing to continue reproductive medical treatment raises several ethical concerns, which can be explored using the five bioethics principles of beneficence, non-maleficence, veracity, distributive justice, and autonomy.

Physicians should adhere first to the principle of non-maleficence, or “do no harm.” At this point, research concerning the effect of COVID-19 on pregnancy and fetuses is extremely limited, and new data emerges daily—but the evidence suggests that COVID-19 can be particularly detrimental for pregnant women. Pregnancy is considered an immunocompromised state, and historically even seasonal influenza is associated with a five-fold increase in perinatal mortality, including miscarriages, stillbirth, and early neonatal disease and death.26 Breslin et al. reported 2 out of 7 asymptomatic women who tested positive for COVID-19 required ICU admissions postpartum.27  Recently, one Boston Hospital had one pregnant patient at 18 weeks and 3 postpartum patients on ventilators, all of whom rapidly decompensated despite feeling well for several days  (in person communication). Three studies discussed possible vertical transmission of COVID-19 from an infected mother to the newborn, fortunately with no sequelea. 28-30.   Proceeding with retrievals and transfers means that patients may experience other unfortunate outcomes that warrant medical attention, including ectopic pregnancies, ovarian torsions, and miscarriages with resulting D&C. Complications from these surgeries are exponentially increased in patients with this virus, and conducting these procedures increases unnecessary exposure for staff members—and their families, creating chain reactions of additional exposures through travel, finding childcare, and so on.  As such, the Society of Reproductive Surgeons and American Association of Gynecologic Laparoscopists have emphasized their opposition to these practices.  Even while N95 respirators can trap particles greater than 0.3 microns, these aerosolized particles may be 0.125 microns.31 Thus, starting new cycles of IVF while confronting this highly contagious, untreatable, and potentially fatal viral infection remains extremely dangerous.

The principle of veracity refers to the physician’s duty to tell the truth, raising the question of whether all IVF clinics have been truthful with their patients about the compounded dangers to themselves and clinical staff from resolving treatment complications in a COVID-19 pandemic. Furthermore, ASRM’s decision to suspend non-emergent IVF treatments implicitly asks physicians to rely on fidelity, the principle that patients should place trust in their physicians. In addition to patients’ trust, physicians must also be candid with staff members about known risks—or the fact that there are many unknowns regarding this virus. The decision to temporarily suspending non-emergent cases to minimize spread of disease and preserve resources reinforces this fidelity, instead of breaking it.

Cessation of treatment with the intent to ration care during a time of crisis exemplifies the principle of justice—prioritizing societal needs over individual or organizational desires. Making a just decision can initiate a contest between opposing interests. Constraints on medical care force providers to allocate resources based on severity of illness; although infertility is considered a disease, it is not a fatal condition. Clinics that remain open are using valuable medical resources, including PPE, that health care workers on the front lines sorely need. As expected, ASRM is not recommending that IVF clinics cease treatment for emergencies or procedures in progress that involve gonadotoxic therapies, and has reinforced this decision with a second update issued April 13, 2020.23 Some clinics cite the principle of autonomy and informed consent to justify proceeding with non-urgent treatments. But in times of triage and rationing care, individual autonomy must be secondary to the collective good. These are by no means simple questions, and grow more complicated when states such as New York deem certain treatment essential. Allowing clinics more leeway to open can create a situation where the autonomy of patients from one practice or in one locale appears to be of greater weight than others. Irrespective of what state governments determine, physicians must act in the best interests of their patients, staff, and communities.

Historically, the government and the public have taken steps to rectify injustices from profiteering. In the Revolutionary War, a mob of women in Boston beat a merchant and confiscated the stocks of sugar and coffee he had been hoarding; a Connecticut mob seized 218 pounds of sugar.18 During World War II, President Truman himself drove 30,000 miles to pay unannounced visits to corporate offices and launched aggressive investigations into questionable wartime business practices, and Congress passed the Excess Profits Tax to combat profiteering from shortages and war contracts, taxing profits that rose above pre-war prices.32 Most recently, the U.S. government used the Defense Production Act to seize hoarded supplies of masks, hand sanitizer, and other essential products, and the FBI has established a COVID-19 hoarding and price gouging task force. 33

Should ASRM take a page from the annals of history to investigate and sanction IVF clinics that continue to perform elective procedures while the current guidance exists? Will IVF clinics that resist closure remain in good standing with SART membership?  Or should ASRM allows clinics to choose whether to prioritize autonomy and the economic safety of their clinics and employees? One must recognize clinics’ efforts to strictly adhere to CDC guidelines, but these guidelines have grown more lax as critical medical supplies dwindle, and risks remain.

ASRM, with its commitment to patient care, has issued its recommendations with intense deliberation and diligence.  It has decisively emphasized that beneficence must, for now, outweigh autonomy As of April 14th, 2020, direct casualties from COVID-19 include at least 125,000 worldwide.4 Grievous economic, social, political, and emotional consequences loom. CDC Director Dr. Robert Redfield reiterated that the most powerful weapon against coronavirus is social distancing34, which mandates maintaining a 6-foot distance from others:  “We’re not defenseless….this virus has a very significant weakness – it can’t swim 7 feet.” Given ASRM’s leadership and guidance, however, the pandemic need not entail a crisis of ethical uncertainty.  

 

References:

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Fertility and Sterility

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Fertility and Sterility® is an international journal for obstetricians, gynecologists, reproductive endocrinologists, urologists, basic scientists and others who treat and investigate problems of infertility and human reproductive disorders. The journal publishes juried original scientific articles in clinical and laboratory research relevant to reproductive endocrinology, urology, andrology, physiology, immunology, genetics, contraception, and menopause. Fertility and Sterility® encourages and supports meaningful basic and clinical research, and facilitates and promotes excellence in professional education, in the field of reproductive medicine.

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