ER Editor: News website Panorama.it has launched a petition to get the drug hydroxychloroquine officially reinstated so that Italian doctors can once again use it with patients. If not, some of them will go ahead and use it anyway. The retracted Lancet study and trials using lethal doses(!) of HCQ were enough to get it officially banned in Italy as in other countries. Except the Italian Medicines Agency (AIFA) has not yet reapproved it, despite studies showing its effectiveness. Here is the content of the Change.org petition translated from Italian:
Covid 19: we ask AIFA (Italian Medicines Agency) to restore the use of hydroxychloroquine
The recent Covid 19 pandemic has made the need for territorial management of the disease manifest. It is now clear to all that in order to win the battle against the virus, it is essential the intervention of the family doctor in the first instance, to activate the necessary diagnostic and therapeutic pathways.
At the moment there are no treatments of proven effectiveness to be administered at home. Because the only therapy that AIFA (Italy’s Medicines Agency) had authorized at home, the one based on hydroxychloroquine, has been blocked. It happened on May 26, after the publication of a study in The Lancet, which was withdrawn 13 days later.
Meanwhile, German GPs, who had administered 1,060,000 doses of hydroxychloroquine in March, continued to prescribe it. In the United States, three states lifted the ban on the drug in early August. In China, on August 19, the National Health Commission’s guidelines continued to recommend the active ingredient for Covid 19 patients. And on September 21, The Lancet itself retraced its steps, with a study claiming that hydroxychloroquine reduces mortality.
In Italy AIFA has remained firm on its positions, based on studies carried out in hospital settings and which, however, have not shown a toxicity of the molecule. Now that the second wave of the pandemic has fully invested our country, there remains the problem of how to manage at home the clinical pictures of small and medium entities, considering that hospital admissions are no longer sustainable.
In order to save lives, we ask AIFA to restore the use of hydroxychloroquine for home patients in the very early stages of the disease, possibly even with an emergency procedure. Otherwise, we invite the Agency to provide shared protocols of treatment practicable in the territory.
Notice in the article below how much is being spent on pointless testing for this disease in France – over 300 million euros per month.
There are some rough spots in the translation below which we haven’t been able to iron out.
Note that we do not subscribe to the ‘second wave’ notion of the virus that is mentioned. Rising ‘cases’ due to false-positive testing are finding no support among current death rates from the virus. We’ve documented how hospitals are admitting people for any kind of illness, and then classifying them as covid upon an automatically-administered, faulty test. Thus, we do not trust hospital figures for admissions.
In Italy, doctors say: “We are going to use chloroquine”. The petition is launched.
ELISABETTA BURBA for FRANCE SOIR
A petition demanding to restore the use of hydroxychloroquine as a treatment against Covid 19 has just been launched in Italy by the media Panorama.it.
After the freedom to prescribe in France, it is the turn of the Italians to mobilize by denouncing the serious failures of the health authorities in the context of decision-making on treatments against Covid. Following the more and more anxious messages from the government and some doctors on television about the increase in the number of Covid cases detected by the very expensive campaign of tests (with 1.291 million tests in Week 41, or 94 million euros spent per week), more and more French people are questioning the health policy and the reality of the situation.
In one month, more than 300 million euros will have been spent on screening for the disease. Compare this with the amount allocated to cancer treatment under Francois Hollande, 1.5 billion euros. If we cumulate three months of intensive testing at 300 million tests per week, that would be nearly 1 billion euros invested in Covid screening. The group Santé en Danger (Health in Danger) is pleading for better use. Couldn’t the public hospitals have not used this billion euros more efficiently?
This Italian petition would confirm the position of the French doctors of the group Laissons Les Prescrire (Let Us Prescribe), who have been asking for the freedom to prescribe since the beginning of the pandemic. The petition goes one step further by asking the health authorities to review their position regarding a temporary authorization of use. We were also surprised that Gilead’s Remdesivir obtained an ATU (temporary authorization for use) from the European Medicines Agency, even though it had significant side effects. (ER: See this report from Zerohedge, titled FDA Approves Gilead’s Remdesivir To Treat COVID-19 Despite Data Showing Drug Doesn’t Work.)
Italian doctors take the same position as their French colleagues, particularly Professor Didier Raoult, who has highlighted in his studies the effectiveness of the dual therapy he has been proposing since March 2020. The position of the French health authorities is all the more astonishing given that the Gilead laboratory has withdrawn its request for reimbursement for Remdesivir, and that Prof. Yazdanpanah announced on television that Remdesivir would probably not be effective. Professor Lina announced in the Senate, the inclusion of Remdesivir in the Discovery trial on the grounds of “avoiding loss of opportunity for patients” when there was no signal of effectiveness.
The two-drug therapy, on the other hand, was clearly not given the “same consideration”. A real break in equality for patients. Italian doctors say it’s time to go back to common sense and to consider medicine as it should be. The British Recovery study, which is at the center of many health policy decisions, reports a significant overdose compared to the dosage used by Professor Raoult’s IHU. It should also be remembered that the IHU (ER: Prof. Raoult) uses a dual therapy with synergistic effects that were not taken into account in the Recovery and Solidarity trial. Pharmacist Mathieu Molinard, who had taken a stand for the high dosage in Recovery, will surely find himself in the middle of a controversy following the publication of a recent study confirming that antimalarial drugs such as hydroxychloroquine inhibit the replication of the Covid-19 virus in vitro at low doses. This study was conducted by the French Army Health Service under the supervision of Bruno Pradines, a pharmacist expert in antimalarial drugs. Inhibition of the virus is easily achieved with low and non-toxic doses such as those used by the IHU. This study would therefore question the toxic or even lethal level doses (four times higher than the dosage used by the IHU) used in Recovery and Solidarity, which resulted in the highest mortality rates in the world in the study arm testing hydroxychloroquine.
Would this be one more scientific error with critical consequences for patients?
Panorama.it is launching a petition to ask the Italian Medicines Agency (AIFA) to reinstate the use of hydroxychloroquine, the only anti-Covid drug available in the country. Otherwise, in an act of civil disobedience, a group of doctors will prescribe it anyway, in order not to abandon their patients and to remain faithful to their Hippocratic oath.
Sign the petition on
Panorama.it conducted a comprehensive survey to understand how Italy is preparing to deal with the second wave of Covid-19. The survey has three episodes:
the cinderella of the fight against the pandemic;
territorial medicine without diagnostic and therapeutic tools;
the civil disobedience of family doctors.
“We will prescribe hydroxychloroquine despite the ban of AIFA. We already administered it in March without authorization. We will do so all the more today, given the good results obtained by us and many other colleagues and proven by various scientific studies.”
When Dr. Andrea Mangiagalli (pictured) reports on the Medicis Group’s kamikaze intentions on the front line, it is with shivers down his spine. Is it possible that doctors could be attacked by their Order, because they would be prescribing a drug that has worked well for decades in the worst epidemic since the Spanish flu, with decisions based on a study that was withdrawn 13 days after publication?
It is possible, because the group of family doctors created last February in Milan does not act out of economic interests, political motivations or ideological positions. And it couldn’t, since neither cash nor golden rules can be used against hydroxychloroquine. At a cost of 6.08 euros for 30 tablets in the original version, and 5.12 euros for the generic version, this antimalarial treatment originally had two major flaws: it costs little and has no sponsor.
Primary care physicians will therefore make an act of civil disobedience, obviously with the consent of the patients, to respect the Hippocratic oath which obliges them to “never abandon the care of the sick”. As one of the promoters of the initiative, Dr. Antonio Gobbi, now retired, pointed out in March,
“if you always work with the risk of complaints in mind, you don’t do anything. The doctor can be assessed for incompetence, recklessness and negligence. We preferred to risk recklessness.”
Your colleagues are in danger of carelessness even today. Much more so than yesterday. If in March, doctors in Milan started prescribing hydroxychloroquine without an AIFA authorization, they will now prescribe it after the authorization was first issued and then withdrawn. An act of courage, which may have a little more than just symbolic value. Of the 43,927 Italian general practitioners, how many will follow them in prescribing hydroxychloroquine against the advice of the Italian Medicines Agency? At best, 1% of them, something like 440 doctors. A number not large enough to solve the problem of the second wave of coronavirus.
That’s why Panorama decided to follow their battle. At a time when the epidemic is back in an acute phase, when the health care personnel who don’t sleep at night because they don’t have beds, when schools are closed, the impossibility of prescribing hydroxychloroquine prevents timely care as it has already been experienced in Italy and in many countries around the world. Because, as Antonio Cassone, former director of the Department of Infectious Diseases of the Higher Institute of Health, says, “hydroxychloroquine in low to moderate doses is absolutely safe.”
Panarama.it has organized an online petition through the Change.org platform to ask the AIFA to reinstate the use of hydroxychloroquine for patients at home during the very early stages of the disease, using if necessary an authorization through an emergency procedure. Before the collection of signatures began, 112 doctors had already joined our appeal.
Below we explain the reasons for our choice. To do so, we have to come back in March 2020. With Lombardy (ER: a region in northern Italy) devastated by the highest lethality rate of Covid-19 in the world, frontline physicians were in complete disarray. Hospitals were on the verge of breaking down and most of the patients were staying at home, left to their own devices. Official therapeutic indications to family doctors suggested that only tachypirin should be administered, pending more serious forms. Do-it-yourself medicine is strongly discouraged, as Professor Galli del Sacco of Milan says.
At that time, the field physicians took the lead in creating a WhatsApp group on February 27th. After meeting with hospital colleagues, studying therapies administered in China, and consulting scientific studies in mid-March, they developed an intervention protocol that they shared. The general practitioners in Milan and the province took on an enormous responsibility. At the center of their program was hydroxychloroquine, a drug currently used for malaria and rheumatological diseases. So much so that in the initial phase, as it was not authorized for Covid-19, doctors had to prescribe off-label (off-market authorization).
“We launched without a parachute,” recalls Andrea Mangiagalli, a general practitioner in Pioltello who worked on the definition of the protocol with his colleagues Antonio Gobbi and Giovanni Moretti:
“We couldn’t have prescribed hydroxychloroquine to our patients because the AIFA had issued a directive against its use. But we didn’t give up, because it was against our code of ethics to make people die without trying anything.”
The result was astonishing: no patient treated in the early stages of the disease needed to be hospitalized. And no one died. A success because shortly after March 31, the Drug Agency finally authorized the use of chloroquine for suspected cases of Covid.
The story that seemed to have a happy ending turned out to be short-lived as, on May 22nd, with the publication of a shock study in The Lancet (British journal). Signed by Harvard professor Mandeep Mehra, the study argued that the risk of death for those who took hydroxychloroquine was 34% higher than for those who did not; and that they had a 137% higher risk of having a serious arrhythmia. The sky fell on us: the World Health Organization immediately stopped testing the molecule. The next day, the Italian Medicines Agency suspended its authorization for Covid. France and Belgium did the same. Followed by the very powerful U.S. Food and Drug Administration.
A debacle… On June 5, however, there was a twist: after receiving a letter from 120 researchers from around the world questioning the study, The Lancet withdrew it. But the damage was done: hydroxychloroquine was now banned. At the same time, hydroxychloroquine had been praised by President Donald Trump and Brazilian President Jair Bolsonaro, so it was hated by the detractors of these two presidents who made a ‘sovereignist’ drug.
And if in other countries like China and India they continued to use it (the Beijing guidelines reiterated the usefulness of the drug in the first place), in Italy, hydroxychloroquine became the pariah of the scientific world. Meanwhile, the case ended up in the courtrooms of the tribunals. On July 26, Neapolitan lawyer Erich Grimaldi filed an appeal with the Tar del Lazio (Administrative Court) with a related precautionary application on behalf of about 50 family doctors from all over Italy. The appeal requested the restoration of the possibility for doctors in the territories to prescribe hydroxychloroquine “freely” against Covid “without assuming prescriptive responsibility”.
Nothing to be done: the ART answered no, “in view of the numerous randomized studies published in the spring of 2020 and referred to in the government measure, on the ineffectiveness – or inefficiency – of the use of hydroxychloroquine”. But what studies was the Regional Administrative Court referring to? In order to understand this, one should consult the update published on the AIFA website on July 22nd. “The most relevant updates are the reporting of data from the hydroxychloroquine treatment arm of the Recovery study in the UK and the publication of the first randomized trial on the use of HCQ in the early stages of infection,” it says.
Randomized: this is the key word, also used by ART to reject the first request from physicians as a precautionary measure.
“A randomized trial is a study in which the assignment of a patient with certain characteristics to a therapy is purely random,” explains Professor Massimo Puoti, Director of the Department of Infectious Diseases at the Niguarda Hospital in Milan. “This is the best way to determine whether a therapy works and how it works.”
Three randomized studies were cited by AIFA to say no to hydroxychloroquine. The first, Recovery, conducted in the UK, is serious and authoritative. “It is the largest randomized study available on hospitalized patients,” explains Professor Massimo Puoti, Director of the Department of Infectious Diseases at the Niguarda Hospital in Milan. “It shows that the use of hydroxychloroquine has neither efficacy nor toxicity above the standard of care for the antimalarial drug.” And what was the standard of care of the study? Mangiagalli answers: “All drugs normally used for pneumonia, including cortisone.”
In short, the study indicates that hydroxychloroquine is no longer effective, but is no more toxic for the therapies commonly used in the hospital. But since hospital treatments such as cortisone cannot be used on patients at home, why not allow the use of hydroxychloroquine, which was not more toxic anyway?
The second study mentioned by AIFA, carried out in the United States and Canada with 423 patients, is not to be taken into account. For two reasons. “First of all, it is not very reliable because 423 patients is too few for a final evaluation,” explains Professor Puoti. The second reason is itself admitted by the AIFA: “The study has some limitations: the definite diagnosis was only possible in 58% of the participants, the evaluations were done online and the primary result was modified during the study” AIFA cites another study that should not even be considered because, notes Professor Puoti, “the confirmed diagnosis of Covid was found in less than 3% of patients”.
Out of the three studies cited by the AIFA, in short, there is only one serious one. “And by the way,” Mangiagalli observes, “even for the best Recovery study there are problems: first of all it concerns hospitalized patients (not at home like our study) and secondly the dosage used is twice as high as the one we prescribed in Italy. No wonder there were cardiovascular side effects.”
In fact, there are also many studies in favor of hydroxychloroquine. “Currently, 102 studies on hydroxychloroquine have been published (62 are peer-reviewed). 75% are positive, while 25% are negative,” says Health Information. The latest was published on September 21 by The Lancet on U.S. data. After May’s misstep, the British journal now claims that hydroxychloroquine reduces Covid’s mortality and finds no increase in cardiac toxicity. The penultimate study, on the other hand, was published on September 20 in the International Journal of Infectious Diseases, and indicates that for hospitalized patients treated with hydroxychloroquine, the risk of transfer to intensive care is reduced by 53%.
But there are also two interesting Italian studies. In the first one, published in the European Journal of Internal Medicine, there is a 30% reduction in mortality for the group of Covid patients treated with hydroxychloroquine. The second, published by the Italian Society of Pharmacology, shows that in nearly two million patients who have been taking hydroxychloroquine for rheumatoid arthritis for 20 years, the seven-day combination with the antibiotic azithromycin did not increase the risk of adverse events.
These studies, however, are not randomized. We asked Luigi Cavanna (pictured), an oncologist at the Piacenza Hospital who pioneered the home prescription of hydroxychloroquine, what he thinks. On March 9, he was the first in Italy to go to the homes of Covid patients to prescribe this antimalarial drug, immediately followed by doctors on the front line in Milan and then, followed very closely, by colleagues from all over Italy, including those from Alessandria.
“Ah, but here we need to use a scholarly quote for our orthodox colleagues in medicine, for the great minds,” ironically begins the oncologist. “I’m quoting from the introduction to the most widespread text of internal medicine in the world, from China to Canada: the Harrison. Here is what he says: “Medical practice combines science and art. Therefore, randomized trials must be the means to treat people well, not the end. A randomized trial is an ordinary response to an ordinary situation. But the Covid is not an ordinary situation. Everyday medicine, real-world medicine is fundamental.
Medical practice that works is essential in extraordinary situations, otherwise we really risk that when we have a randomized study, a lot of people will be there. Apart from the fact that there are almost no randomized studies in the territory, alongside the randomized study, there has to be real evidence, real world evidence”.
To support Cavanna, Mangiagalli intervenes: “if we’re being honest, there are no randomized studies in the territory, even for the flu vaccine. So what should IYFF do: suspend its use? Cavanna can’t help it:
“There is a problem… Why stop a seven-day therapy with a drug that some people, such as people with rheumatoid arthritis, have been taking all their lives? Something is wrong, something is bothering me…”
Also disturbing are the words of Professor Antonio Cassone:
“Unfortunately, editors of major journals are very reluctant to publish anything positive about chloroquine and hydroxychloroquine. What kind of world are we in? I am ashamed to be a doctor.”
In conclusion, the ART also argues that there is no irreparable risk of potential harm, as it does not take into account the “risks of serious and irreparable harm in the legal field of the claimants resulting from the use of one treatment over another.” In other words, according to the judges, the doctors who appealed did not suffer harm as a result of the prohibition on the use of hydroxychloroquine, since they could have used other therapies.
Perhaps the TAR/ART, which next week will be seized with a new request for summary proceedings (in the hope of the applicants that they will not have to go to trial on the merits or to the Conseil d’Etat), does not know that other therapies do not in fact exist. “There are none available in territorial medicine,” confirms Cavanna. “We need to make sure that we can give hydroxychloroquine for seven days, at doses other than those given to horses, as many U.S. studies have done that show no negative effects. In fact, of the tens of thousands of cases treated for seven days in Italy by hospital and general practitioners, there have been no cases with side effects.”
Are you therefore in favor of the collection of signatures promoted by Panorama? “Yes,” answers Dr. Cavanna:
“I support the use of all legal means that may allow a Covid patient to take hydroxychloroquine. Because this seems to me to be a Kafkaesque situation, a crisis of science. Assuming there is no other will behind it, but I don’t want to think so.”