Covid and home care for patients is still chaos, especially due to the use of two therapies on which doctors are divided, hydroxychloroquine and cortisone, “between TAR’s straight-leg interventions and the State Council. Then there is high tension between AIFA, scientists, Regions and family doctors”. This was underlined by the lawyer Stefano Putinati, associate professor of criminal law at the University of Parma, in an in-depth analysis on the information and scientific dissemination site ‘MedicalFacts’ founded by virologist Roberto Burioni.
“In recent days, controversy is mounting on home care (therapies) for the Covid-19 disease. The issue of the dispute is, above all, linked to the use of the drug known as hydroxychloroquine (Hcq) in home care in the early stages of the disease. ” use of hydroxychloroquine – an antimalarial drug that is part of the so-called disease-modifying antirheumatic drugs that is used in the therapy, as well as malaria, also rheumatoid arthritis and systemic lupus erythematosus – since the early stage of the disease is very, very controversial and, in fact, opposed by most scientists for the treatment of Covid-19 “, Putinati recalls.
But how did this chaos start? “A group of general practitioners turned to the administrative courts to change some Aifa cards and guidelines, in particular to be able to use hydroxychloroquine in the initial stages of the disease on non-hospitalized patients – recalls the lawyer – The Council of State (Section Three), on 11 December 2020, accepted the precautionary appeal (we are therefore waiting for the TAR to fix the hearing on the merits of the matter) proposed by a series of general practitioners and reformed the ordinance number 7069 of 16 November 2020 of the Tar for Lazio, Rome office, suspending the effectiveness of the Aifa note of 22 July 2020 with reference to the hydroxychloroquine card, thus allowing, at this time, the prescription, under specific responsibility and under strict control of the prescribing physician, hydroxychloroquine to patients affected by Sars-CoV-2 in the initial phase of the disease “.
Subsequently, the Lazio TAR, Rome office, on March 4, 2021, again as a precautionary measure, “accepted the direct appeal for the cancellation, after suspension of its effectiveness, of the Aifa note of December 9, 2020 containing ‘management principles of Covid19 cases in the home setting ‘in the part in which in the first days of Sars-covid illness, it only provides for a’ vigilant waiting ‘and administration of NSAIDs and paracetamol, and in the part in which it sets indications of not using all the drugs generally used by general practitioners for Covid-19 patients “.
The TAR, in particular, “affirmed that general practitioners have the right and duty, having legal relevance both in civil and criminal matters, to prescribe the drugs they deem most appropriate according to science and conscience. remember, precautionary (provisional) that will be discussed on the merits at the public hearing of 20 July 2021 “, underlines Putinati.
Following the two precautionary measures, the Piedmont Region has recently modified the protocols for home therapies of Covid-19 and, as reported by the regional councilor for health, Luigi Genesio Icardi, has formalized “the use of hydroxychloroquine in early stage of the disease, together with non-steroidal anti-inflammatory drugs and vitamin D “. Roberto Burioni, among others, spoke out against this decision and urged, in no uncertain terms, “to get rid of hydroxychloroquine if prescribed, as it is not only useless, but according to scientific evidence, dangerous”. On the other hand, Aifa in its files had advised against the use of this drug due to lack of efficacy and an increase in adverse events. The same thing has been done by the US FDA since April 2020.
There has also been controversy and divisions over the use of corticosteroids (cortisone). “Recently another decisive stance on home therapies for Covid-19 was taken by the infectious disease specialists of the Sant’Orsola Polyclinic in Bologna who in a letter sent to the Bologna Medical Association underlined how they were arriving more and more patients, even young people, with a severe Covid infection because they would have been given a cortisone-based treatment early – reconstructs the lawyer – In a nutshell, they wrote, general practitioners must be aware of their responsibility in the moment in who venture into such and other prescriptions outside the guidelines, it must be clear that a cortisone treatment initiated within seven days of the onset of symptoms promotes viral replication and therefore infection and its consequences’ “.
Moreover, the letter continues, “the ministry has in any case advised against the use of cortisone on the territory in patients with Covid-19, with the sole exception of subjects receiving home oxygen therapy”. These patients, among other things, “should be hospitalized if, due to basic conditions, they are eligible for intensive treatment”. There was a response from the association of general practitioners at the Sant’Orsola hospital, to which the Bolognese specialists responded by admitting that they may have mistaken the ways of communication, but not the contents. “Alberto Zangrillo and Roberto Burioni of the San Raffaele hospital also identified, among other things, ‘cortisone at the first line of fever’ in the initial phase as a cause of aggravation of the disease – warns the criminal lawyer – the AIFA on this point indicates in its guidelines that the use of corticosteroids is recommended ‘in hospitalized subjects with severe Covid-19 disease, subjects who need oxygen supplementation, with or without mechanical ventilation (invasive or non-invasive)’ recalling numerous sources and lines international guide “.
On home care there are also aspects related to medical criminal negligence to be analyzed. “The case of a diagnostic error of the disease, of erroneous identification of the guidelines for the specific case or of imprudence, the doctor always remains punishable even for a culpable error even venial. In short, in the event of an unfortunate event, only in the hypothesis of inexperience ( execution of the therapy) for the doctor who follows the guidelines or the so-called ‘best practice’, there will be an effective limitation of culpable liability “, highlights the associate professor of criminal law at the University of Parma.
“In light of the above, a series of questions arise spontaneously: there could be criminal consequences, in the event of unfortunate events for Covid-19 patients, for doctors who, independently, decide home care therapies by moving away from the lines guide? How much will the decisions of the administrative courts affect any ascertainment of liability in the case of therapies that prematurely compromise the clinical picture? How to identify the ‘best practice’ in the initial phase of the disease? Many questions, perhaps too many, which do not seem easy to answer ” , adds the lawyer.
“It is a confused phase, in which the administrative judges determine the content of guidelines whose contents, apparently, should be delegated to the scientific committees of the highest regulatory authorities (Aifa); in which the infectious doctors of primary hospitals report hospitalizations of people, even young people, with serious clinical pictures due to too early use of cortisone, in line with the indications of Aifa and confirm top experts from other structures and feel accused of arrogance and defamatory statements and, finally, for some Regions, the ‘hydroxychloroquine returns to medical protocol, despite the doubts, the perplexities of authoritative bodies such as the American Fed and the most accredited infectious disease specialist in the world Anthony Fauci, such as Aifa, well everything seems very complicated and difficult to define “, warns the teacher.
“To avoid future involvement in any criminal proceedings, in the event of deaths also caused by treatments that leave doubts to the scientific community, which are indicated as premature (cortisone) in determining situations, or even potentially harmful, it would be advisable, also in respect of autonomy of the doctor in front of the disease and the concrete case, follow guidelines accredited by the scientific community – Putinati suggests – Furthermore, it should be remembered that when a drug is administered in ‘off-label’ mode, i.e. outside the cases and pathologies for which the drug is authorized, the responsibility, in the event of an adverse event due to the drug, lies with the doctor who prescribes it for the different use (for example hydroxychloroquine) and not with the pharmaceutical company that produces it “.