Italy: Doctors’ Appeal to Prescribe Hydroxy Succeeds Against Medicines Agency

Covid, “yes to hydroxychloroquine”. The Conseil d’État upheld the doctors’ appeal against the Aifa’s note suspending use


“The persistent uncertainty as to the therapeutic efficacy of hydroxychloroquine, admitted by the same AIFA (Italian Medicines Agency) as a justification for further evaluation in randomized clinical trials – it says in the prescription – is not a sufficient reason at the legal level to justify the unreasonable suspension of its use on the national territory”.

Section III of the Council of State accepted, as a precautionary measure, the appeal of a group of general practitioners and suspended the July 22nd note of the Italian Medicines Agency prohibiting the off-label (i.e. over-the-counter) prescription of hydroxychloroquine for the treatment of patients with Covid-19. “The persistent uncertainty as to the therapeutic efficacy of hydroxychloroquine, admitted by the Aifa itself to justify further evaluation in randomized clinical trials’ reads the prescription ‘is not a sufficient reason from a legal point of view to justify the unreasonable suspension of its use in Italy”. In one of the passages, the judges write that “it is not a question, as the AIFA states, of examining the merits of questionable choices, but of verifying whether these choices are assisted by rational credibility supported by valid scientific laws and correctly applied to the case at hand”. The order was issued after a group of 150 doctors challenged the note suspending the use of the drug on May 26.

The dispute was brought before the Council of State after an alternative course of action, which began before the Regional Administrative Court of Lazio, where it was first rejected by protective order, and then challenged before the Council of State by lawyers Valentina Piraino and Erich Grimaldi. It all began 9 months ago, during the first wave of the pandemic, when the AIFA had authorized the use of hydroxychloroquine even at home. Authorization was then denied on May 26, following a scientific article published in The Lancet that claimed the drug increased the mortality rate of patients with Covid 19. A few days later, on June 2, The Lancet withdrew the study because it contained false clinical data.

Since then, many physicians – who had used the drug and evaluated its clinical effectiveness using observational tools – have sued, claiming that the drug was effective. Since then, data collection and publications have multiplied. Currently, 195 studies on hydroxychloroquine have been published (131 have been peer-reviewed) and almost 70% of them report sufficiently positive data (most of these studies are retrospective-observational). AIFA’s brake had been motivated by several randomized studies, the strongest of which referred to two mega trials randomized by WHO, Recovery and Solidarity, both of which would have confirmed the drug’s ineffectiveness, but both focused on a “study” of “advanced” disease, which was in contradiction with the thesis supported by the 150 doctors, including chief hematologists, heads of infectious disease departments, general practitioners and USCA, which limited the use of the drug to “early” interventions, i.e., the drug should be administered at the onset of the first symptoms of the disease, after which the drug would reduce its actual effectiveness.

Doctors complained that their autonomy of decision-making, protected by the Constitution and the law, was violated by prescribing the drug on their own responsibility to patients who were not hospitalized. “The choice of whether or not to use the drug, in a situation of doubt and contrast in the scientific community, on the basis of unambiguous clinical data, concerning its efficacy only at the early stage of the disease – the order of the Council of State states – must be referred to the autonomy of decision and responsibility of the individual physician,” “in science and conscience,” and with the obvious informed consent of the individual patient. The constant and attentive monitoring of the doctor who prescribed it remains firm. The order specifies that the IAAF’s decision to exclude the prescription of hydroxychloroquine outside the MA from the reimbursement scheme is not subject to suspension (or litigation).




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