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With the right to wide publicity by the government and a ceremony with the presence of President Jair Bolsonaro, the antiparasitic nitazoxanide, sold in Brazil under the brand name Annita, was presented this Monday (10/19) at the Planalto Palace as a promising treatment for the covid. -19 at the beginning of the infection.
What would prove this success, according to the government, would be a clinical trial (involving humans) with the drug, usually a more important and prudent step in drug experiments, a step beyond in vitro testing. However, the government has not yet delivered, neither to the press nor to the scientific community, any document with the results of the study.
But this study, coordinated by the Ministry of Science and Technology, does not need publication. According to data from the COVID-NMA system, in which research projects from around the world are registered, no study with nitazoxanide in patients has yet been published. Of the more than 1,900 trials with various drugs registered there, 24 projects involve the antiparasitic drug, most of them in Brazil (7 trials), Egypt (7) and the United States (3). Some of these are already recruiting patients, but none have been completed or published.
An article published by Egyptian scientists in the journal Journal of Genetic Engineering and Biotechnology indicated that nitazoxanide would be a good candidate for clinical trials for having shown, in some investigations in vitro, action against the coronavirus. It would also favor its already documented antiviral action against other coronaviruses, influenza viruses, hepatitis C and B.
However, even in vitro the success of nitazoxanide did not seem unanimous: a study published on a prepress platform (still without the so-called peer review and publication in a scientific journal) by Brazilian researchers has ruled out its effectiveness against the coronavirus.
Today, this drug is marketed in Brazil by several companies, even as a generic one, and in the leaflet it is used to treat viral gastroenteritis and intestinal parasites, among others. Its use is contraindicated for people with diabetes, liver and kidney diseases, as well as those with allergies to components of the formula.
Would the government’s proposed use be for “repositioning”? that is, the use of an existing drug in pharmacies with an original purpose other than the treatment of covid-19.
As indicated in an institutional video, the Minister of Science and Technology (MCTIC), Marcos Pontes, nitazoxanide has the benefits of being produced in Brazil, cheaply and with reduced side effects. In July, Pontes announced that he had covid-19 and was voluntarily treated with nitazoxanide.
Responsible for the coordination of the trials, the doctor and professor Patrícia Rocco, from the Federal University of Rio de Janeiro, said at the event this Monday (10/19) that the clinical trials with the antiparasitic involved 1,575 volunteers in seven units of health in São Caetano; Barueri; Juiz de Fora; Sorocaba; Federal District; Bauru; and Guarulhos. They were divided into a group that received, between June and August, the antiparasitic and another, placebo (a harmless drug).
As announced, patients who received nitazoxanide had a greater reduction in viral load and negative results for a faster coronavirus.
According to the MCTIC press office, the details of the trial have not yet been presented because they are being analyzed for publication in an international scientific journal; otherwise, its disclosure would break the originality of the research, which is desirable in this medium.
However, for biologist Natalia Pasternak, president of the Questão de Ciência Institute, there would be alternatives for the results of the trial to be published without impeding their international dissemination. In August, the institute even opened a request through the Access to Information Law for more information about the nitazoxanide research project.
Faced with the justification given by the government on Monday that the results could not be presented since they would interrupt the publication process in an international magazine, Pasternak indicates that the alternative of disclosure on prepress platforms (even without the so-called peer review), a fundamental step in magazines) exists for it.
“Especially during the pandemic, many more preprints have been published than usual, precisely because we know that peer review takes time. And even the most prestigious journals, such as Lancet, Nature, Science, do not have a problem if the preprint was published. before “.
“We joke that in science, if you haven’t published it, you haven’t (research) published it yet.”
