By Randolph Fillmore
In 2007, the World Health Organization (WHO) issued a report titled Ethical considerations in developing a public health response to pandemic influenza. While the report focused on an influenza pandemic rather than a coronavirus pandemic, a viral pandemic is a viral pandemic.
The purpose of the WHO 2007 report was to “assist social and political leaders at all levels who influence policy decisions about the incorporation of ethical considerations into national influenza pandemic preparedness plans.” The document focuses on priority-setting and equitable access to resources, restriction of individuals’ movements as a result of non-pharmaceutical interventions, including isolation of cases, quarantine of contacts, limiting social gatherings, and highlighting the obligations of health care workers, their employers and governments.
In 2007, WHO said “…implementation of public health measures aimed at limiting social interaction (such as restrictions on gatherings and population movements) are likely to have a major impact on trade and tourism. In view of these possible consequences, countries and the international community must prepare to cope with a pandemic and mitigate its impact.”
Many critical ethical questions arise in viral pandemic planning, preparedness and response. According to WHO, these questions include: Who will get priority access to medications, vaccines, and intensive care unit beds, given the potential shortage of these essential resources? In the face of a pandemic, what obligations do health-care workers have to work, notwithstanding risks to their own health and the health of their families? How can surveillance, isolation, quarantine and social-distancing measures be undertaken in a way that respects ethical norms? What obligations do countries have to one another with respect to pandemic influenza planning and response efforts?
WHO went on to say that authorities imposing social distancing/quarantine orders have ethical and moral obligations to provide “employment protection” for workers who comply with social distancing measures and that social distancing plans require authorities to take measures to mitigate adverse cultural, economic, social and emotional health effects on individual and communities (to the extent possible) resulting from social distancing or quarantine.
Is it unethical for employers to demand health care workers work without adequate protection?
WHO said health care workers do have a “moral obligation to work” during a pandemic, but that the obligation is not “unlimited.” WHO said health care facilities have an ethical obligation to provide personal protective equipment (PPE) “in line with technical advice” and, additionally, that health care workers had an obligation to use the PPE.
Recall there have been several cases of nurses who refused to work without proper PPE, resulting in their dismissal.
“I don’t believe it is unethical for health care workers to say they are notgoing to work if they don’t have personal protective equipment,” says Alison Bateman-House, PhD, an assistant professor in New York University’s Department of Population. “We can’t demand people to self-sacrifice. It was unethical to penalize those workers.”
Health care workers are not the only ones under the COVID-19 “gun.” Meat packing plant workers have been ordered to go back to work, although the workers say they do not have proper PPE. One hopes they can appeal to a Higher Authority – OSHA – the Occupational Safety and Health Administration. Born in 1970 with the Occupational Safety and Health Act, OSHA says that “workers have the right to a safe workplace.”
One section on the OSHA website highlights OSHA standards and directives (instructions for compliance officers) and other related information that may apply to worker exposure to the novel coronavirus, SARS-CoV-2 that causes Coronavirus Disease 2019 (COVID-19). Among the most relevant aspects are OSHA's Personal Protective Equipment (PPE) standards (in general industry, 29 CFR 1910 Subpart I), which require using gloves, eye and face protection, and respiratory protection when job hazards warrant it. There is also guidance for when respirators (masks) are necessary to protect workers. Employers must implement a comprehensive respiratory protection program in accordance with the Respiratory Protection standard (29 CFR 1910.134). This may not be happening, as it appears that when employers call employees back to work it may not be in keeping with OSHA regulations.
Who gets a ventilator, who does not?
Early in the pandemic, the nation-wide shortage of ventilators – the “breathing machines” that force oxygen into the lungs and help keep people with failing lungs alive – became apparent. Some estimates were that the U.S. would need millions when only about 100,000 ventilators existed nationally.
Some of the earliest COVID-19 “cures” came when the sickest of people were placed on ventilators and “breathed” for a rather long time. However, many of those placed on ventilators died anyway. Given the ventilator shortage, does that reality mean that it could have been determined that this personwas so sick and so close to death that putting them on a ventilator was futile? Perhaps someone else could have been put on that ventilator and lived to tell about it.
Ethical controversy over ventilators gained more momentum, albeit temporarily, when a paper published in the Journal of the American Medical Association (JAMA) on April 22 said that 88% of those placed on ventilators in New York City died, regardless.
Two days after publication, JAMA put out a correction based on an overwhelming number of medical experts who over two days commented that there was something wrong with the data. The correction said that 24.5 % (282) of the 1100-plus patients on ventilators died. Not 88%. Even with this correction, the question remains open as to who should be put on a ventilator and who might not be a candidate given the simple fact that everyone who might be a candidate could not get one. It’s a tough, “lifeboat” decision about who lives and who dies.
“First-come-first-served is an allocation of its own,” says Bateman-House. “But in this case, it might not be a random cross section of the population. Questions about ‘who can afford the care, who can get transportation to the hospital, and who has a cell phone to call 911?’ are issues.”
What is a doctor to do?
“It might be best to do what doctors tend to do – and that is make individual determinations about patient changes and maximize the care to those with the best changes,” suggests Bateman-House. ”Does the data show signs that this patient is not going to survive? Data enables us to come up with protocols.”
Looking at the data for making these kinds of ethical decisions is what researchers at the Johns Hopkins University and the University of Pittsburgh did in collaboration in 2013. Their study into ventilator use/triage became solid guidelines that could be put in place when necessary, and likely deemed ethical. Or not.
Under the subtitle: “Categorically Excluding Large Groups of Patients from Receiving Mechanical Ventilation Is Ethically Problematic,” researchers published a paper in JAMA on 20 April 2020 looking at a framework for rationing ventilators and critical care beds during the COVID-19 pandemic.
The original 2013 report suggested a ventilator allocation based on saving as many lives as possible in two ways: the likelihood of short-term survival enabling the patient to leave the hospital; and the likelihood for long-term survival of at least 12 months.
The 2013 report is now a framework living deep within the pages of the University of Pittsburgh’s website.
Here is what the framework says: When ventilators are a scarce commodity, prospective ventilator patients are scored for suitability on an 8-point system. Short-term survival is based on an adult patient’s organ failure assessment score using laboratory values and organ function indicators. For long term survival, patients needed to score from 0 to 3 and would be “high priority.” Those patients likely to die within one year would be scored a 4-5 and would be intermediate priority. Scores of 6-8 would be the lowest priority. The scores would be computed by a qualified “triage team” and reassessment could be done in any of the three categories. The teams are also open to “appeals” from the patient’s family. With borderline scores, age can also be a determining factor.
The framework explains reassessment:
“The ethical justification for such reassessment is that, in a public health emergency when there are not enough critical care resources for all, the goal of maximizing the benefit for communities of patients would be jeopardized if patients who were determined to be unlikely to survive were allowed indefinite use of scarce critical care services. In addition, periodic reassessments lessen the chance that arbitrary considerations, such as when an individual develops critical illness, unduly affect patients’ access to treatment.“
Going ethically and morally forward into 2021’s unknowns
The Center for Infectious Disease Research and Policy at the University of Minnesota released a report 30 April 2020 saying “…the length of the pandemic will likely be 18 to 24 months, as herd immunity gradually develops in the human population…we must be prepared for at least another 18 to 24 months of significant COVID-19 activity, with hot spots popping up periodically in diverse geographic areas. As the pandemic wanes, it is likely that SARS-CoV-2 will continue to circulate in the human population and will synchronize to a seasonal pattern with diminished severity over time.” https://www.cidrap.umn.edu/covid-19/covid-19-cidrap-viewpoint
One of the center’s recommendations is that “risk communication messaging from government officials should incorporate the concept that this pandemic will not be over soon and that people need to be prepared for possible periodic resurgences of disease over the next two years.”
If this drags on for years, or if a new pandemic takes over where this one left off, or we have more than one pandemic at a time, what should we stop doing, and what should we start doing to responsibly improve the ethical and moral public health response?
Things to Start doing if (or before) CDC declares an epidemic or if WHO declares a pandemic
We should de-politicize pandemic response to the extent possible taking pandemic response - including quarantine and drug research - out of political hands and put it entirely into the hands of the directors of the U. S. Centers for Disease Control and Prevention (CDC) , the U.S. Food and Drug Administration (FDA), the Biomedical Advanced Research and Development Authority (BARDA), and the US Public Health Service (USPHS).
- If quarantine is warranted, take economic care of those stuck at home, especially those left unemployed
- Allow the WHO/World Bank Global Preparedness Monitoring Board (GPMB) https://apps.who.int/gpmb/about.htmlto play a role in determining outbreak seriousness and advise in steps to reduce outbreak effects
- Nationalize health care materials production and distribution in serious health emergencies
- Develop a national health crisis unemployment fund; repurpose and pay workers to do pandemic-related tasks (off-label work?) for which they will be trained during non-pandemic times
- Boost and accelerate federal funding of continuous vaccine research, both influenza, corona, Dengue fever and others, and have continuous, forward-looking development and full phase 1-3 clinical trials on new drugs rather than on re-purposed drugs
The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, was established to aid in securing the nation in times of chemical, biological, radiological, or nuclear (CBRN) threat, as well as reacting to pandemic influenza (PI) and emerging infectious diseases (EID). https://www.phe.gov/about/barda/Pages/default.aspx
BARDA’s important mission is to support the development and application of medical countermeasures, such as vaccines, drugs, and diagnostics. BARDA’s mission extends from research through advanced development towards consideration for approval by the FDA and, ultimately, to inclusion of medically appropriate products into the Strategic National Stockpile.
That BARDA has been stifled from carrying out its mission should be considered an immoral and unethical political maneuver. It should be alarming to all Americans as such a move stands as an example of the extreme politicizing of a critical federal government functional unit aimed at preserving the health and welfare of all citizens in times of serious natural or human-made threats.