Call for ethics in vaccines in Europe: do no harm and let more die?

European health agencies have faced this week, with millions of lives at stake, an incredibly high-stakes incarnation of what ethicists call the cart problem.

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

In the European version, German regulators have identified seven cases of rare cerebral blood clots, including three fatalities, out of 1.6 million people who received the AstraZeneca vaccine. Regulators had no evidence of their connection, only a statistical anomaly. Still, continued vaccinations could make them responsible for putting a handful of people at risk – like pulling the lever on the cart rails.

Instead, German authorities withdrew approval for the vaccine as of Monday. Neighboring countries followed suit, waiting for the European Union’s pharmaceutical regulator to deem the vaccine safe, which it did on Thursday.

It may sound like a strange choice. With a third viral wave claiming thousands of lives a day in Europe, even a brief hiatus seemed almost certain to put many more lives at risk than the unproven and very rare side effect.

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

Dr McMahan, who studies life and death dilemmas, said additional Covid deaths likely to occur “would be by omission, or by doing nothing, rather than causing. But you have to ask yourself, does that make a difference in this context? “

But Ruth Faden, a Johns Hopkins University bioethicist and vaccine policy expert, called the break “an extremely difficult decision.”

“If the only thing that mattered was to deploy the vaccine in a way that reduced serious illness and death as quickly as possible, then go for it,” said Dr Faden. But this is not the case. While the countries that continued to vaccinate “probably made the right choice,” she said, Germany and others faced real considerations of public trust and ethical duty.

And it won’t be the last time in the pandemic, experts said, that leaders will be forced to weigh possibly flawed treatment against the high costs of caution.

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

“This idea of ​​the precautionary principle plays an important role in EU policy,” said Govind Persad, bioethicist at the University of Denver. This principle calls for the suspension of any policy that could lead to unforeseen harm in order to study such harm before proceeding. To impose a blind risk, however small, on unconscious citizens would be a mistake.

But Dr Persad said he had “never really been able to understand how you would apply this principle in the event of a pandemic.”

On the one hand, even though vaccinations carried some risk or uncertainty, the risk and uncertainty introduced by refusing them, thus allowing cases to spread, was surely higher. It wasn’t as if the infections stopped for a bureaucratic process.

For another, vaccinations are voluntary.

“This is not a case where you are imposing risks on unwilling people,” said Dr Persad, and therefore violate the precautionary principle. “You allow people to consensually protect themselves from a great risk by taking a very small risk.”

Imagine, he said, “you’ve got someone stuck on a subway track, and there’s a service ladder they want to use to get out.”

Europe’s approach, he said, was akin to going up the ladder, telling the stuck person they couldn’t use it until they had been tested in the matter. security for the general public.

“It’s true that a ton of Brits use scales like this and it’s okay,” he said, referring to the widespread use of the AstraZeneca vaccine in Britain. “But we can’t let you hurt yourself.”

In these situations, he said, it’s generally considered more ethical to give people all the information so they can make an informed choice about 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, such as when companies recall an unsafe product rather than simply slapping a warning label. But limiting people’s access to cabbage during an E. Coli does not harm them; withholding a life-saving vaccine does.

“In Germany there is a very great reluctance to agree to impose affirmative harm on people in compromise situations,” said Dr Persad. “It’s a very strong emphasis on doing no harm, even if you allow a lot more harm by inaction.”

This unusually high aversion to anything that could be seen as a violation by the government of autonomy or individual dignity is, like so much in Germany, a reaction against the country’s Nazi past.

With Germany’s position as first among its peers in the European Union and a greater distrust of not appearing permissive about vaccine safety, others quickly followed, notably France, Italy and the ‘Spain.

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

Even though administration of doses with unproven potential to harm patients at roughly the same risk as being struck by lightning could be considered inadmissible under this oath.

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

And while “do no harm first” may sound like a iron law of medical ethics, it is in fact primarily a code of professional conduct. For centuries, this has reflected an innate human prejudice that affirms causing harm is categorically different from passively allowing it.

“This do / allow asymmetry is of course not just in medical codes but in law,” said Dr McMahan. Especially the law of responsibility.

The German health ministry statement acknowledged this, 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 and more dead, Dr McMahan said, for a public health agency, weighing one’s own responsibility against the survival of hundreds or thousands of others “would be really terrible.”

Just as policymakers might like to make a purely medical decision, said vaccine bioethicist Dr Faden, they also need to think about keeping the public trust.

Skepticism about vaccines was already high in Europe, especially regarding the AstraZeneca vaccine, on which Europe has built its plans. The proportion of people willing to be vaccinated has, in some polls, fallen well below the 70 percent needed to gain herd immunity.

“The vivid, vivid events that are truly frightening have a way to control the public imagination,” said Dr Faden.

A pause, she added, can be a way to “reassure the public that you, as a public health authority, or as a government, take any signal that appears like this very seriously.” “

The hope is that this will build confidence in health authorities, demonstrating that they place caution and safety before rushing to arms. Even if people are not sure about the vaccines themselves, perhaps a great deal of confidence in the vaccinators could overcome this problem.

But for ethical reasons, Dr Persad said: “It seems like a troubling line, to say that a person’s access to treatment should depend on how it might affect the comfort or the psychology of a third party. .

It is also a bet. The delay imposed by European governments risks aggravating public doubts about the vaccine. And now those responsible must show that they take these three deadly clots seriously, which means drawing more attention to them.

“It’s a safe and effective vaccine,” Emer Cooke, executive director of the European Union’s medicines regulator, said on Thursday, urging countries to restore its use. Nonetheless, she urged governments to “raise awareness of these potential risks”.

“Bringing attention to these possible rare diseases,” she said, “will help identify and mitigate possible side effects.”

Asked whether Americans could ever face such a dilemma, Dr Persad replied that they had already done so. Although trials may show the Johnson & Johnson one shot with a lower efficacy rate than the two-dose variants, health officials have hailed its simpler distribution as a breakthrough in promoting herd immunity. . The Americans largely followed.

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

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