Hydroxychloroquine, a drug used to prevent and treat acute attacks of malaria in adults and children weighing more than 31 kg, was prescribed to patients hospitalized with Covid-19 during the first wave of the virus. Its use could be related to approximately 13,000 premature deaths in six countries, of which 2,799 occurred in Spain.

In a paper published in Biomedicine & Pharmacotherapy, a group of researchers has estimated premature mortality in relation to treatment with hydroxychloroquine in six countries: Belgium, Turkey, France, Italy, the USA and Spain.

The objective of the study was to calculate the number of deaths attributable to the use of this treatment in 2020, during the first months of the pandemic.

Using median estimates of hydroxychloroquine use in each country, 13,226 hospital deaths may be related to the prescription of this medication in the six countries evaluated. By country, the data are as follows: in Belgium 10,018 patients received treatment and 231 died, in Turkey 15,656 received it and 77 died, in France 15,600 received it and 299 died, in Italy 72,635 received it and 2,237 died, in the US they received it 551,471 and 7,583 died and in Spain 87,437 received it and 2,799 died.

However, and according to Diario Médico after analyzing the study data, Dr. Javier de Miguel, head of Pneumology at the Gregorio Marañón Hospital in Madrid, has declared that “above all, caution. It is evident that treatment with hydroxychloroquine has shown that it is not useful in Covid-19 patients and, therefore, it is ruled out for this disease. But it also seems very forceful, and not prudent, to affirm that mortality has increased among patients who received it.”

Dr. De Miguel also states that hydroxychloroquine therapy was administered along with many other drugs, such as azithromycin, also linked to cardiac side effects. In addition, the most serious patients were also subject to other types of conditions, such as previous pathologies or age, which could also have played a later role. “The studies showed that it was not effective because it does not reduce mortality in patients with Covid-19. But another thing quite different is that it increases mortality, as has now been pointed out. It seems a bit risky.”

It should be recalled that in 2020, during the Covid-19 crisis, the then President of the United States Donald Trump was taking hydroxychloroquine as a preventive measure to avoid contracting the disease, despite little evidence of its efficacy and the intensity of its side effects.

Trump repeatedly recommended its use during White House briefings on the coronavirus pandemic despite the fact that the FDA advised against its use in July 2020.

Bioethical assessment

On the one hand, the use of medications without proper authorization by regulatory agencies constitutes a practice that should be avoided. Exceptionally, the “compassionate use” of some unauthorized drugs for the treatment of certain pathologies is accepted in the absence of effective therapeutic alternatives. And also when there is a serious condition that does not allow waiting for the development of the complex procedure for the authorization of the drug.

In order to ensure whether a drug is sufficiently effective to treat a pathology, what dose should be used, the side effects to be expected after administration and the patients for whom it is intended, costly clinical trials are conducted to provide certainty about a positive benefit/risk balance.

During the Covid-19 pandemic, the lack of available effective treatments, given the unknown nature of the disease, led to numerous attempts to apply different treatments in a desperate attempt to curb the high mortality recorded, especially in the early stages.

The news now published raises the possibility that one of these tested treatments, hydroxychloroquine, may have caused premature deaths in affected patients without contributing any benefit to the evolution of the disease. This fact reinforces the need to scrupulously apply prudent criteria in the use of pharmacological treatments that have not been sufficiently tested.

However, it should also be noted that assuming an unequivocal relationship between the administration of hydroxychloroquine and the increase in mortality from Covid-19 is also imprudent if there is not sufficiently solid evidence to be able to affirm it.

As in other spheres, also in medicine, the desire to create press headlines that seek to offer news or create unnecessary alarms moves away from the ethics that should accompany the management of information, which must be offered with rigor and prudence.

Julio Tudela and Ester Bosch

Bioethics Observatory – Institute of Life Sciences

Catholic University of Valencia

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