Italian ozone therapy treatments: the question of ISS consent

The SIOOT, the organisation claiming great success in treating COVID-19 with ozone therapy, says it received consent from the Italian ISS (Istituto Superiore di Sanita, Higher Institute of Health), and made the letter it received available on its website as a PDF.

However, the ISS has since stated that it did not give “consent” for ozone treatment, nor is it its role to give such authorisation. They state that the letter was “informal”, and that it emphasised that evidence for this therapy should be confirmed through a trial authorised by the Italian Medicines Agency (translated):

CS N ° 25/2020 – Ozone therapy, it is not part of the ISS to authorize experiments
ISS, March 26, 2020

In relation to the news reported by various press bodies that the Istituto Superiore di Sanità has given its consent to the use of the treatment of ozone therapy in patients with Covid-19, the Institute specifies that:
It is not part of the Institute’s duties to issue this type of authorization.
The ISS has not issued an authorization in this sense but, in an informal correspondence, has instead emphasized that the evidence brought in support of the use of this therapy for the treatment of COVID-19, should be confirmed, given the objective therapeutic, via an experiment authorized by the Italian Medicines Agency.
In the same correspondence, indications were given for any experimental investigations.

The original letter seems to clearly state that, while a clinical trial must receive consent from the Italian Medicines Agency, the treatment itself (not performed as part of a trial) may be carried out with informed consent of the patient, under the doctor’s responsibility, if approved by the Ethics Committee. I have found no indication yet whether the Ethics Committee was consulted or gave approval for the treatment. I’ve translated the original letter:

Rome, March 24, 2020

Viale Regina Elena, 299
00161 Rome
Telegrams: Istisan Roma
Telephone: 06 49901
Fax: 06 49387118
http://www.iss.it

Prof. Marianno Franzini
Comunian Gorle Clinic
Via Roma, 79
24020 Bergamo

Dear Prof. Franzini,
the proposal for a possible use of Oxygen Ozone Therapy in the treatment of interstitial coronavirus pneumonia has been carefully evaluated by some ISS experts.
Although the proposal is supported by a certain rational basis, the data actually available with respect to the proposed indication essentially consist in demonstrating the effectiveness of ozone in killing the SARS virus in monkey cells, and in the clinical experience of the benefit found in patients with bronchopneumonia.
It is not easy to establish whether this level of evidence is sufficient to support the use of the treatment in patients with coronavirus infection, especially since – depending on the concentrations used, the endogenous anti-oxidant capacities and the patient’s immune status – the ability of ozone to determine a direct activation of the immune system could induce the appearance of toxic effects.
Moreover, the SIOOT Guidelines published in 2018 also attribute to the indications “lung diseases” only a level of type C evidence.
Evidence of this type should be confirmed through a clinical trial and, in this case, receive authorization from the Italian Medicines Agency [Agenzia Italiana del Farmaco] (although ozone is not a drug, in fact, any clinical study with therapeutic objectives must follow the authorization procedure for medicines).
However, since the proposal seems to be shared and supported by clinical centers experienced in the treatment of viral pneumonia, if deemed appropriate, the treatment could be carried out under the responsibility of the doctor, after obtaining the patient’s informed consent. Considering the “experimental” nature of the use, this indication, which requires, moreover, specific experience on the part of the doctor and the availability of appropriate instruments, it is considered appropriate to acquire the opinion of the Ethics Committee.
Informal contacts between the director of the ISS Medicines Department and the Director of the UOC Infectious Diseases of the Sacco Hospital in Milan confirm the latter’s availability for a scientific trial with your scientific society.
Staying available for any developments, we take this opportunity to extend our best regards.

The Head of the Scientific Secretariat of the President,
Dr. Luigi Bertinato

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