Letter to The Lancet 2 giugno 2020

Letter promoted by our Movement and supported by Italian physicians and professors and sent to The Lancet, sent to WHO for information, on June 2

 

TO:

The Editor-In-Chief Richard Horton of The Lancet journal

richard.horton@lancet.com

and the Editorial Board

editorial@lancet.com

astrid.james@lancet.com

r.cooney@lancet.com

He.wang@lancet.com

 

 

c.c.:

World Health Organization

20, Avenue Appia

1211 Geneva 27

Switzerland

empinfo@who.int

 

 

 

From a group of Italian medical doctors.

 

Dear Sirs,

 

SUBJECT: Serious and distorting media information of a medical-scientific nature transmitted by mass media through multiple sources concerning drugs that have proven effective for the treatment of cases of COVID-19: possible serious consequences on the availability of authorised therapeutic drugs throughout the territory in the event of a possible reappearance of pandemic outbreaks, with consequent risks both for the citizens and for the economy.

 

As emerges from the subject above, there is in progress an altogether unjustified media campaign aimed at discrediting the use of hydroxychloroquine-based drugs, which constitute the only effective and inexpensive tool available to general practitioners both in the town and in the countryside. This campaign is the fruit of the manipulation of a recent scientific paper that appeared in the magazine The Lancet

 (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31180-6/fulltext).

The conclusions of the study, to which the mass media in Italy, France, the United States, and much of the rest of world refer, report, in a way that does not at all reflect the reality of the situation, how chloroquine and hydroxychloroquine appear to be the cause of death due to cardiac problems. The very authors of the article acknowledge the limits of the study.

Without wishing to dwell on the matter too long, for completeness we present in greater detail an objective analysis that any physician guided by the principles of science and conscience ought to be able to make.

The paper published in The Lancet, on which the conclusions of the WHO are based, is an observational study that includes patients who are already at an advanced stage of the disease, the possible death of whom cannot necessarily be put down to the use of chloroquine or hydroxychloroquine, but rather to the disease itself and to already pre-existing pathological conditions.

In particular, the population of patients included in the study would have to undergo an in-depth examination on account of certain evident observations, namely:

1) Approximately 12% of the patients considered were already suffering from unspecified coronary-artery disease, where an inflammatory condition such as coronavirus infection, which has been shown to produce severe endotheliitis and coagulopathy, can increase the underlying endothelial damage and destabilise the thrombotic material, thus leading to a worsening of ischaemia with serious arrhythmias and unfavourable  outcome, which can be attributed to the infection itself and not necessarily to the therapy.

2) Some 5% of the patients were suffering from congestive heart failure, the NYHA class of which that identifies the seriousness of the condition is not, however, specified, nor much less the ejection fraction, which is an expression of heart function.

3) Even more seriously, some 3.5% of the patients presented arrhythmias, without any specification of the nature and severity, irrespective of the treatment.

4) In conclusion, hypertensive, obese, and diabetic patients were included, who in previous studies have been pointed out as being at a higher risk of mortality.

The most disturbing aspect that emerges is the fact that the aforementioned categories have been inexplicably included in the study WITHOUT the slightest hint as to the problem of QTc (corrected QT interval).

Why is QTc fundamental and why does EVERY ITALIAN HOSPITAL measure it every 48 hours for COVID-19 patients?

QTc is a measurement that is made with a normal surface electrocardiogram.

The limit values of QTc ​​are the following: 0.44 s for men, and 0.45 s for women.

Lengthening of QTc could trigger an arrhythmia referred to as torsade de pointes, which degenerates, in a very high percentage of cases, into ventricular fibrillation, which is a fatal arrhythmia if not immediately treated with electrical defibrillation.

This measurement, which, we repeat, is used in every Italian hospital, defines the criterion of exclusion of such patients from treatment with chloroquine or hydroxychloroquine.

In many cases, the above patients with heart-related comorbidities were in a lower percentage in the control groups as compared to the corresponding groups treated with hydroxychloroquine or chloroquine.

To sum up, these are all patients who presumably were not adequately evaluated for  safe administration of chloroquine or hydroxychloroquine.

The conclusions drawn by the authors of the paper have distracted attention away from the true problem emerging from the data provided therein.

How is it that doctors in the hospitals considered in the study administered chloroquine or hydroxychloroquine to cardiac patients, when the lethal effects on this type of patients have been clearly ascertained?

Why is it that the adverse cardiac effects induced by the virus in terminally ill patients, who were included in the study at a stage that was already too advanced for them to be cured, were ascribed to the use of chloroquine or hydroxychloroquine?

And above all, why did the mass media as a whole omit to mention this evidence?

Nobody has taken the trouble to investigate the details of the study, to the point of citing, as source of the study, the Sorbonne, which, instead, has nothing to do with the paper in question.

Rheumatoid-arthritis patients take hydroxychloroquine for years, at the same dosages as those envisaged for the treatment of COVID-19 in the early stages, without manifesting any side effects.

In this context, it is impossible to understand the directive issued by the World Health Organization to stop use of hydroxychloroquine only for patients suffering from coronavirus infection, who, on average, take it for an overall period ranging from 7 to 12 days.

The wide use that has been made all over the world of hydroxychloroquine, together with azithromycin, in patients in the first stage of the disease, has made it possible to save their lives (China, South Korea, Mauritius, some regions of Germany, some regions of Italy, and many other countries and areas of the world).

Currently, hydroxychloroquine is used in 90% of Italian hospitals, as well as in some hospitals in France and the USA, along with other drugs, for treating even the most serious COVID-19 patients (administration of hydroxychloroquine in new patients was stopped in Italy on May 28 following upon the directive issued by AIFA, the Italian drug agency).

There are studies already published and in the process of publication on the efficacy of hydroxychloroquine prescribed under safe conditions, with an excellent recovery rate when administered together with azithromycin at the beginning of the disease (within the first 3 or 4 days), without any adverse effects.

Instead, very elderly people with two or more comorbidities should be hospitalised and treated with hyperimmune plasma, whereas for patients who are already at an advanced stage of disease and in the absence of pre-existing diseases, it will be up to the individual hospital to decide what other drugs to use in addition to hydroxychloroquine and azithromycin and whether to resort to hyperimmune plasma.

In this way, it is possible to approach a very high recovery rate of around 98%.

This would mean a mortality rate of probably less than 2%.

Such a rate is very far from the average rate in Italy, being in line with the mortality rate of a normal seasonal influenza.

On the basis of the evidence reported in the paper appearing in The Lancet, which is clearly not very solid and presents conflicting features, serious decisions have been made by the WHO that leave not only general practitioners but also hospital doctors no longer with weapons available to counter the progression of pulmonary disease and thus reduce hospitalizations and mortality.

It is moreover to be recalled that there are many countries in the poorer areas of the world where the disease is progressing, and hydroxychloroquine represents the only weapon in the possession of medical personnel.

All the foregoing risks dealing a severe blow to Italy and many other countries in the world, which would once again find themselves unprepared to face a new pandemic outbreak.

The countries that have used, at a home-treatment level,  hydroxychloroquine in combination with azithromycin at the earliest signs of the disease have overcome the outbreak in a short time, in many cases without any need to resort to a lockdown.

The lives of thousands of potential patients are at risk, as is also the economic recovery of almost every country on the planet.

We trust in a prompt intervention on your part.

We send you our kindest regards.

Italy, June 2, 2020

 

 

Promoters:

Prof. Claudio Puoti, MD

Infectologist and Hepatologist, Head of Liver Unit, INI Research Institute and Clinics, Grottaferrata, Rome

Hepatologist Consultant, National Cancer Institute “Regina Elena”, Rome

Professor, “N. Cusano” University, Rome

 

Andrea Mangiagalli, MD

General Practitioner

 

Dott. Mauro Rango

Human-Rights Activist  and Right-to-Health Expert

 

Antonio Marfella, MD

Pharmacology Specialist

President of the Naples Section of ISDE (International Society Disease of Environment)

 

Adriana Privitera, MD

Cardiologist

 

Terenzio Mari, MD

Hepatologist

 

 

Signatories (80 physicians):

 

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