On the release of AstraZeneca’s lots

After the Italian Council of State’s (the Supreme Court for Administrative Law) order on the off-label administration of hydroxychloroquine, once again judiciary powers judiciary show their unfamiliarity with logic and the scientific method. The price to pay is the delay in the vaccination campaign and the increase in distrust of vaccines by Andrea Monti – Initially published in Italian by Scienza in Rete

In the last three weeks, two Italian public prosecutors seized batches of the AstraZeneca vaccine. The first was the Syracuse prosecutor’s office, which, as the Ministry of Health publicly states, issued the order ‘as a precautionary measure in order to carry out the appropriate clinical tests to refute the dangerousness of the drug’. Then the Biella public prosecutor’s office alleged the crime of involuntary manslaughter due to a person’s death one day after administering the drug.

On 31 March 2021, a week after the seizure, the Biella public prosecutor’s office partially released the batches it had blocked, while there are no updates from the Syracuse public prosecutor’s office to date.

These seizures are the umpteenth fruit of the irrational application of the precautionary principle, of having equated the post hoc to the principle of causality, and the refusal to accept the fact that vaccines, like all drugs, can be dangerous and even lethal, but not for this to administer them means committing a crime.

Let us start with this last point: a drug can be intrinsically lethal in a certain percentage of the number of administrations. It is a known risk and is declared in the approval procedure by the health authorities. In the absence of other elements, if death occurs because of the drug’s fault, there can be no crime. Consequently, even if there is evidence of a causal link between the administration and the death, seizing entire vaccines’ batches would make no sense.

A fortiori, it is impossible to seize entire batches of vaccines based on the mere temporal contextuality because, unless there are other elements, there cannot be a crime, not even abstractly. Affirming this principle means replacing the principle of causality with the post hoc as a criterion for attributing criminal responsibility. Consistently, then, an investigation should be launched every time someone dies after having put any alien substance – such as food, for example – into their body. There is no basis for such an argument. Consequently, it is impossible invoking the precautionary principle to justify the decision to seize, which, in reality, has no rational basis.

In order to understand the sense of this conclusions, it is necessary to remember that the criminal judiciary can only order a seizure in three cases: to guarantee the payment of damages and the costs of the trial, the need to acquire evidence to identify the author of a crime, the need to avoid the continuation of a crime or to avoid the commission of others. In the first case, we talk about ‘conservative seizure’, which is not relevant in the case we are examining. In the second (handled directly by the public prosecutor), we speak of ‘probationary seizure’. In the third (which requires the Judge’s authorisation for the preliminary investigations), one speaks of preventive seizure.

Excluding the hypothesis of the preventive seizure (which would arise, to remain in the pharmacological domain, to stop the circulation of adulterated medicines), there remains that of having to gather evidence in support of an accusation. But of having done what?

If – at least as media report – the criminal proceedings in Biella for manslaughter were opened based on a mere temporal contextuality, there is no element to assume the existence of a crime. Therefore it would not even possibile invoking the precautionary principle to justify the seizure of all the doses contained in a batch. There could have been other kind of suspicions to ground the decision. A doubt on the specific way that a particular dose was stored or prepared. The assumption of severe medical negligence in the assessment of the patient’s medical history. The failing to take appropriate post-dose control measures. By contrast, none of such (or similar) facts occured.  And also if they did, it would not have been possible to deduce the need to seize hundreds of thousands of doses. The only rational explanation is that prosecutores acted in the irrational belief that a drug must be harmless and if it is not, it means that someone is responsible.

Although worrying, the Biella case’s lack of logic is much less marked than in the reasoning behind the seizure of the vaccines ordered by the Syracuse prosecutor’s office.

First of all, we read in the statement of the Ministry of Health, the prosecutor excluded a ‘direct correlation’ between the administration of the drug and death. Firstly, the term ‘direct correlation’ is used surreptitiously as a synonym for causation and not in its proper meaning of statistics. Secondly, even if one were to pretend to not having spotted the semantic substitution made on the words ‘direct correlation, in this specific case, the Ministry of Health acknowledges that there is no evidence leading for the Syracuse public prosecutor’s office to a crime. To have ordered the seizure is a non sequitur: there is no evidence to be acquired without a crime.

Finally, the reason given by the Ministry of Health to justify what happened is – to put it mildly – paradoxical: the seizure was not necessary to investigate a crime but to carry out ‘appropriate clinical analyses to refute the dangerousness of the drug’. This statement is hardly tenable. Pharmacovigilance is not a task of the criminal judiciary, and in any case, the prosecutor must, if anything, prove that a drug is dangerous despite having been authorised and send those responsible to trial.

In short, both the seizures ordered by the prosecutors in Piedmont and Sicily are unfounded and have slowed down the vaccination campaign. Since, however, interpretation of laws, unlike the speed of light, is decided by a show of hands, it is always possible that a Bysanthine argument could justify the apparent lack of logic of these decisions. All that, regardless of the negative consequences on the strategies to contain the spread of coronavirus.

It is hardly suprising, though, as everybody knows since Roman law that a judgment facit de albo, nigrum.

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