Posted on March 29, 2021 at 6:33 PM
Brian M. Cummings, MD and John J. Paris, SJ, PhD
In The New York Times, almost overlooked amidst multiple articles on Covid-19 published that day, we found a challenging essay by Max Fisher entitled, “Europe’s Vaccine Ethics Call: Do No Harm and Let More Die”? Fisher inquires whether clinical bioethics should accept the decision of Germany to suspend the use of AstraZeneca’s Covid-19 vaccine due to blood clots because of what bioethicists label “The Trolley Problem”.
The ‘ Trolley Problem’ is a thought experiment designed to describe a decision-making process. It involves a scenario in which someone is standing at a railway switch. If the decision-maker does nothing, a trolley coming down the track will hit and kill three people. If the person at the switch pulls a lever, the trolley will divert to an alternative track where there is one person. The question posed is, “Which option is morally preferable”? This thought experiment finds its modern version in how self-driving cars should be programed to be moral.
While the “Trolley Problem” might make for an interesting discussion at an ethics seminar on utilitarianism, it bears little resemblance to decision making in a clinical setting. Max Fisher concludes his article with the comment of Govind Persad, a University of Denver bioethicist, that “The ethical trade off actually comes up all the time.” That reality occurs routinely in today’s hospitals. In such situations a patient is informed of the potential risks and benefits and determines whether or not to undergo the procedure.
If there is a potential conflict, the case is brought to an institutional ethics committee which provides a forum for an open discussion of the issues. For example, we experienced and reported on one such complicated ethical deliberation which can be seen through the trolley problem framework. That case involved the proposed separation of conjoined twins where the surgery would inevitably result in the demise of Twin A and the potential survival of Twin B. The decision maker could choose omission of any intervention and accept the death of both infants. Or, the parents and team could opt for surgical intervention, with the knowledge one twin would be harmed, while the other had a chance at survival. Is omission the more moral path? For whom?
In the Fisher essay, Johns Hopkins bioethicist Ruth Faden labeled the AstraZeneca pause as “an extremely tough call,” one that risked eroding patient trust in the vaccine. Further problems arose one week later when U.S. federal health officials and an independent oversight board claimed, “AstraZeneca presented potentially misleading information about the effectiveness of the company’s vaccine.” The charge was an extraordinary blow to the credibility of a corporation whose vaccine is seen as critical to the European and the developing world’s fight against the pandemic.
Dr. Anthony Fauci, the United States’ leading vaccine scientist, echoed Ruth Faden saying, “Any type of thing like this could unfortunately contribute to a lack of confidence in the process.” Vaccine hesitancy among the public works against the wide spread inoculation required to slow the spread of the virus.
The issue Fisher highlights is that German regulators identified 7 cases of a rare blood clot, 3 of them fatal, out of a total of 1.6 million individuals who had received the AstraZeneca vaccine. The regulators did not detect evidence of a link between the vaccine and the blood clots, but did notice a statistical anomaly within the data. AstraZeneca then confronted two simultaneous problems: continuing vaccinations might put a handful of people in harm’s way, and the prospect that a significant number of individuals who refused to be vaccinated might endanger the possibility of the ‘herd immunity’ required to end the pandemic.
Fisher notes that within a week of withdrawing the vaccine, German regulators deemed the vaccine ‘safe’. “This”, he observes, “seemed as strange choice.” He concludes, “Experts tend to view Europe’s decision either as an understandable if risky, cost-benefit calculation or, as Oxford University ethicist Jeff McMahan put it, ‘a disastrous mistake.’” McMahan referred to the extra Covid-19 deaths due to delayed vaccination as occurring “by omission” rather than by “causation.” As Fisher notes, “You have to ask does that make any difference in this context”?
Here Fisher is raising the topic posed by Sissela Bok in her 1999 edition of Lying: Moral Choice in Public and Private Life, where she labeled the omission of a known truth as “lying by omission.” Bok’s comment created a problem. By calling the omission of a known truth –the refusal of the Dutch hosts to acknowledge to Gestapo agents the presences of the Jewish Frank family in their home– as ‘lying by omission’ Bok placed an ‘omission’ in the same category as ‘a positive action’. Doing so creates confusion. It also tends to leave those in a state of uncertainty to default to no action. During a pandemic, declining a vaccination — or precluding its distribution — could have severe negative consequences with regard to the spread of a virus.
In a world in which ‘alternative facts’ have become widely accepted, presenting inaccurate efficacy data, or presenting the inaccurate data as a ‘fact’ in support of one’s vaccine’s effectiveness or safety has the potential to destroy trust in the vaccine. It might also preclude the possibility of achieving the ‘herd immunity’ required to end a pandemic. We agree with Crigger and Wynia that in situations of uncertainty, “Honesty is the best policy.”
In the aftermath of an unexpected complication, what do you tell the family who asks, “What went wrong. You tell the truth and nothing but the truth, avoiding any speculation.
The regulators overseeing the safety and efficacy of the AstraZeneca vaccine do not know of a ‘causal’ relationship between the vaccine and the incidence of the 7 cases of a blood clot out of some 1.6 million recipients of the AstraZeneca vaccine. Regulators, out of an abundance of caution, could suspend the use of the vaccine until they had the opportunity to examine the data and make them public or — as is regularly done in medicine — announce what is known and leave the risk-benefit calculation to those who are to receive the vaccine. Leaving the risk-benefit decision to individuals may increase vaccine hesitancy. But the shutdown of distribution and new limits on who can receive the shot, will significantly delay our ability to achieve herd immunity and end this pandemic.