Europe’s Vaccine Ethics Call: Do No Harm and Let More Die?

Europe’s Vaccine Ethics Call: Do No Harm and Let More Die?

Europe’s Vaccine Ethics Call: Do No Harm and Let More Die?

Europe’s Vaccine Ethics Call: Do No Harm and Let More Die?

European health agencies this week faced, with millions of lives in the balance, a staggeringly high-stakes incarnation of what ethicists call the trolley problem.

Imagine standing at a railway switch. If you do nothing, a trolley barreling down the track will hit three people in its path. If you pull the lever, the trolley will divert to an alternate track with one person. Which option is morally preferable: deliberately killing one person or passively allowing three to die?

In Europe’s version, German regulators identified seven cases of a rare cerebral blood clot, three of them fatal, out of 1.6 million who had received the AstraZeneca vaccine. Regulators had no proof they were linked, only a statistical anomaly. Still, continuing vaccinations might make them responsible for putting a handful of people in harm’s way — like pulling the lever on the trolley tracks.

Instead, the German authorities withdrew approval for the vaccine starting Monday. Neighboring countries followed, waiting for the European Union drug regulator to deem the vaccine safe, which it did on Thursday.

It might seem like a strange choice. With a third viral wave claiming thousands of lives per day in Europe, even a brief pause seemed all but certain to imperil many more lives than the unproven, very rare side effect.

Still, medical ethics can be tricky. Experts tend to view Europe’s decision as either an understandable, if risky, cost-benefit calculation or, as the Oxford University ethicist Jeff McMahan put it, “a disastrous mistake.”

Dr. McMahan, who studies life-or-death dilemmas, said that the extra Covid deaths likely to occur would “be by omission, or by not doing anything, rather than by causing. But you have to ask, does that make any difference in this context?”

But Ruth Faden, a Johns Hopkins University bioethicist and vaccine policy expert, called the pause “an extremely tough call.”

“If the only thing that mattered was deploying the vaccine in such a way as to reduce severe disease and death as quickly as possible, then you just go ahead,” Dr. Faden said. But it isn’t. While countries that continued vaccinations “probably made the right call,” she said, Germany and others faced real considerations around public trust and ethical duty.

And this will not be the last time in the pandemic, the experts said, that leaders will be forced to weigh a possibly flawed treatment against the heavy costs of caution.

Germany’s health ministry said in a statement, “The state provides the vaccine and therefore has special duties of care,” such as monitoring for risks and responding if certain conditions are tripped. Even, the statement acknowledged, if the decision cost more lives than it saved.

“This idea of the precautionary principle plays a big role in E.U. policy,” said Govind Persad, a University of Denver bioethicist. That principle calls for pausing any policy that might bring unforeseen harms in order to study those harms before proceeding. Imposing blind risk, however small, on unknowing citizens would be wrong.

But Dr. Persad said that he had “never really been able to make sense of how you would apply that principle in a pandemic.”

For one, even if vaccinations did carry some risk or uncertainty, the risk and uncertainty introduced by withholding them, therefore allowing cases to spread, was surely higher. It was not as if infections paused for bureaucratic process.

For another, vaccinations are voluntary.

“This is not a case where you’re imposing risk on unconsenting people,” Dr. Persad said, and therefore violating the precautionary principle. “You’re allowing people to consensually protect themselves from a big risk by taking a very small one.”

Imagine, he said, “You have somebody who’s stuck on a subway track, and there’s a service ladder that they want to use to climb out.”

Europe’s approach, he said, was akin to pulling up the ladder, telling the stuck person that they couldn’t use it until it had been safety-tested for the general public.

“It’s true that a ton of British people use ladders like this and they’re fine,” he said, referencing the widespread use of the AstraZeneca vaccine in Britain. “But we can’t let you hurt yourself.”

In those situations, he said, it is usually considered more ethical to give people all the information so that they can make an informed choice on how best to protect themselves.

Such concessions are already common in medicine, many with exponentially greater risks and lower chances of success than the vaccine: elective surgeries, vaccine trials, experimental cancer treatments.

There are exceptions, like when companies recall a hazardous product rather than simply slap on a warning label. But limiting peoples’ access to cabbage during an E. coli outbreak doesn’t harm them; withholding a lifesaving vaccine does.

“In Germany, there’s a very great reluctance to countenance imposing affirmative harm on people in trade-off situations,” Dr. Persad said. “It’s a very strong emphasis on not causing harm, even if you allow much more harm through inaction.”

This unusually high aversion to anything that might be seen as the government violating individual autonomy or dignity are, like so much in Germany, a reaction against the country’s Nazi past.

With Germany’s position as first among equals in the European Union, and a broader wariness against appearing permissive on vaccine safety, others quickly followed, including France, Italy and Spain.

Still, the thinking behind Europe’s decision also reflects something universal: the Hippocratic oath, “First, do no harm.”

Even so much as administering doses with an unproven potential to harm patients at about the same odds as being struck by lightning could be considered impermissible under that oath.

“But when the alternative to doing a small amount of harm is allowing a vast amount of harm, then the ‘do no harm’ slogan is a poor guide to policy,” said Dr. McMahan, the Oxford ethicist.

And while “first, do no harm” can feel like an iron law of medical ethics, it is in fact primarily a professional code of conduct. For centuries, it has reflected an inborn human bias that sees affirmatively causing harm as categorically different than passively allowing it.

“That doing/allowing asymmetry is of course not just in the medical codes but in the law,” Dr. McMahan said. Especially liability law.

The statement from Germany’s health ministry acknowledged as much, writing that, if it allowed vaccinations “to continue without properly informing the population and those receiving the vaccine, there could also be legal consequences.”

But in a country with 74,000 deaths and counting, Dr. McMahan said, for a public health agency to weigh its own liability against the survival of hundreds or thousands more “would be truly terrible.”

Much as policymakers might like to make a purely medical decision, Dr. Faden said, the vaccine bioethicist, they also have to think about guarding public confidence.

Vaccine skepticism was already high in Europe, especially toward the AstraZeneca shot, on which Europe has built its plans. The proportion of people willing to get the shot has, in some polls, dropped significantly below the 70 percent needed to achieve herd immunity.

“High-profile, vivid events that are really scary have a way of controlling the public imagination,” Dr. Faden said.

Pausing, she added, can be a way of “reassuring the public that you as a public health authority, or as a government, take super seriously any signal that comes up like this.”

The hope is that this builds trust in the health authorities, demonstrating that they put caution and safety ahead of rushing shots into arms. Even if people remain unsure about the vaccines themselves, perhaps high trust in the vaccinators could overcome this.

But on ethical grounds, Dr. Persad said, “It seems like a troubling line, to say that one person’s access to treatment should be dependent on how that might affect the comfort or psychology of a third party.”

It is also a gamble. The delay imposed by European governments risks a deepening of public doubts about the vaccine. And now officials must demonstrate they take these three fatal clots seriously, which means calling more attention to them.

“This is a safe and effective vaccine,” Emer Cooke, executive director of the European Union’s drug regulator, said on Thursday, urging countries reinstate its use. Still, she urged that governments “raise awareness of these possible risks.”

“Drawing attention to these possible rare conditions,” she said, “will help to spot and mitigate any possible side effects.”

Asked whether Americans might ever face such a dilemma, Dr. Persad countered that they already did. Though trials may show the one-shot Johnson & Johnson with a lower efficacy rate than two-shot variants, health officials hailed its simpler distribution as a breakthrough in the push for herd immunity. Americans have largely gone along.

“We don’t always see it,” Dr. Persad said of these ethical trade-offs, “but it actually comes up all the time.”


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