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Ten thousand Italians could recover immediately, like so many Donald Trumps. Instead, pending a vaccine, Italy faces the third wave of Covid without therapies based on monoclonal antibodies, those that in three days neutralize the virus avoiding hospitalization. The vans loaded with these drugs actually leave a Latin factory, but they are meant to save American patients, not Italian ones. To those who, in addition, had been offered for free two months ago. It is the paradox of a story that has important health, political and ethical implications. “We have ‘bullets‘anti-virus specifications. They can save thousands of patients, prevent hospitalizations and infections, but we decided not to shoot them. It is not explained ”, he has been repeating for days Massimo clementi, virologist at the San Raffaele in Milan.
He says his colleagues in the United States have been giving him for a few weeks neutralizing antibodies as therapy and prophylaxis for Covid patients. The same cure that saved Donald Trump’s life in a few days, despite their age and overweight: “After 2-3 days they recover without apparent side effects.” Such a 1000 euros on the verge of a full treatment, against the 850 euros of a daily hospitalization.
America bought them 950 thousand doses, followed by Canada and, yesterday’s news, Germany. Not Italy, where they are produced. Our country has invested in a monoclonal made in Italy promising but only available in 4-6 months. Very pragmatic scientists wonder why, in the meantime, drugs that have already proven their effectiveness elsewhere are not being used: since October, it turns out that Italy had now been given the opportunity to use these antibodies through a so-called “clinical trial “. in which 10 thousand doses of the drug would have been free proposals. A hand from heaven mysteriously rejected as the country plunged into the second wave.
The drug – bamlanivimab o Cov555 – was developed by the American multinational Eli Lilly. Its effectiveness in reducing viral load, symptoms and risk of Recovery is tested by one Phase 2 study randomized (phase 3 is ongoing) conducted in the USA. The results were illustrated in the prestigious New England Journal of Medicine. From the headquarters of Sesto Fiorentino they explain that the antibody was put into production even before the end of the test so that it would be available worldwide as soon as possible.
Since November 9, when the FDA authorized its emergency use, the U.S bought almost one million doses. In Europe, the green light is expected from the EMA, which does not authorize drugs Developing. However, a 2001 European directive allows individual EU countries to proceed with purchasing and Germany yesterday completed the process to authorize it. Soon it will be Hungary’s turn. Is it Italy? Wait. Have your European heart in gates of florenceAfter the study was completed, the Indianapolis company contacted national health and political authorities, including those in Italy. the October 29th meeting with Aifa: connected, among others, Gianni rezza for the Ministry of Health; Giuseppe Ippolito of the Cts and director of the Spallanzani of Rome; professor Guido Silvestri, a virologist at Emory University in Atlanta who had favored contact with Eli Lilly. On the table, the possibility of starting experimentation in Italy with at least 10 thousand free doses of the drug that in the US has been shown to reduce the risk of hospitalization by 72 to 90%. In this context, it is also made clear that it would not have been a favor for the multinational, on the contrary: once the FDA had authorized it, applications from other countries would have gone.
The opportunity, to be seized on the fly, falls on deaf ears, perhaps due to strict adherence to AIFA and EMA regulations that have not stopped rigorous Germany. Another hypothesis: the offer was abandoned due to a choice already made upstream. The government has invested in monoclonals since March 380 million for a totally Italian project run by the foundation Tuscany Life Sciences (TLS), ente nonprofit from Siena, in collaboration with Spallanzani and directed by the luminaria Rino Rappuoli. The clinical trial has not yet started and production, barring problems, will begin only in the spring of 2021. As for the Fact, the operation with Eli Lilly, which two months ago would have saved thousands of people, would not have taken finished. for the critical attitude towards these antibodies of the director of Spallanzani who will work on the Siena project. “I don’t know why it was like this, you have to ask AIFA,” the director cut off. Giuseppe Ippolito, denying a conflict of interest: “I do not prescribe drugs, I only deal with science.”
When the FDA authorizes the drug, the multinational can no longer offer the free trial, but must stick to the parent company’s price. Ironically, with the disappearance of the zero cost option, Italy expresses an official expression of interest in buying. The negotiations take place on November 16 in the presence of Arcuri, DG Aifa Magrini and the Minister of Health. hope. There is talk of price and dose but the negotiation stops there and does not continue. Not even when the mayor of Florence returns to office. Dario Nardella announces to the newspapers that he has spoken with the leaders of Eli Lilly and that “if there is the approval of the EU Commission, the distribution of the drug based on monoclonal antibodies could begin after Christmas not only in France, Spain and United Kingdom but also in Italy “. Christmas is upon us and in Italy there is no trace of antibody drugs and there is no news of pressure from AIFA to apply for the European agency. As if the therapeutic option for patients fighting the virus, already available elsewhere, was of no interest.
AIFA and the Arcuri structure – heard by the fact – reiterate: as long as there is no authorization from the EMA, we cannot continue. You can even die from too much caution, scientists respond. “It would have accelerated,” says the minister’s adviser clearly Walter Ricciardi, present at the meeting a month ago: “With so many deceased and hospitalized, assessing all available therapies early is an ethical and moral imperative.” The virologist Silvestri, who had pushed so hard: “I don’t understand what is blocking the introduction of Lilly and / or Regeneron antibodies, which we use here in the United States with very encouraging results.” Last night the critical voice of the immunologist from the University of Padua Antonella Viola was added: “This delay is surprising, what are we waiting for?”
For Professor Clementi, we are before the paradox. “It is important to find the best drug possible, but we cannot rule out one a priori therapeutic possibility that in other places saves people. A vial costs a little more than a day of hospitalization and any resources you save can be used for something else. Keeping a weapon in its sheath that is decisive is incomprehensible. Hence my request to AIFA ”.
Of course, a 100% Italian solution would guarantee self-sufficiency and preference in acquisitions. From Sesto Fiorentino, however, they respond that their medicine, in addition to the benefits in terms of health and savings, would also have economic repercussions for Italy: an Italian supplier, Latina BSP Pharmaceutical, is involved in the production. “If it goes well, we could distribute it not only in the United States but also in Italy,” the owner of the Pontine company exulted in March. Aldo braca. Nine months later, the most promising drug against Covid leaves the Latina plant. But it only goes abroad.
Article updated on November 17
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