Health Secretary cites irregular and under investigation research to defend ‘Covid kit’

A technical note from the Ministry of Health in defense of the so-called “Covid kit” cited scientific research conducted irregularly in the assessment of Conep (National Research Ethics Commission).

The study is in the sights of the MPF (Federal Public Ministry) due to the high number of deaths recorded. The Covid CPI asked for the indictment of one of the authors for crime against humanity.

The technical note also includes research by doctors allied with the Jair Bolsonaro government (PL) in the dissemination of ineffective medicines against the coronavirus. The document defends hydroxychloroquine and ivermectin.

Secretary of Science, Technology, Innovation and Strategic Inputs of the Ministry of Health, Hélio Angotti Neto signed the note. It was used to explain his veto of a directive from Conitec (National Commission for the Incorporation of Technologies to SUS) against the “Covid kit”.

On December 7, the body approved, by 7 to 6, guidance that contraindicates ineffective drugs in the outpatient treatment of Covid. On January 21, Angotti decided to reject the collegiate text.

Sought, the Ministry of Health did not respond until the publication of this text.

To justify the veto, Angotti said in the technical note that the guideline excluded promising drugs against Covid. One of them, according to the secretary, is proxalutamide, a still experimental drug that is being tested in the fight against cancer.

“The current scenario has reaffirmed some hope in the association of drugs, including those with so-called repositioned use, such as fluvoxamine, or not yet registered and repositioned, such as proxalutamide (Cadegiani, 2021)”, he wrote.

According to Conep, the research coordinated by endocrinologist Flávio Cadegiani failed to comply with agreed rules. The study should have been carried out in Brasília, but it took place in Amazonas, Rio Grande do Sul and Santa Catarina.

In addition, the number of participants was higher than the approved number. Conep reported the situation to the PGR (Attorney General’s Office) last year and reported the record of 200 deaths during the study.

“The survey was carried out irregularly, it approved one thing and did another. I have never seen a survey with this number of deaths”, said Jorge Venâncio, coordinator of Conep. “Despite repeated requests made to the researcher, no justification was provided for this number of deaths.”

The Covid CPI in the Senate even claimed that Cadegiani committed a crime against humanity. A request for indictment was made, now under analysis by the Prosecutor’s Office.

In a note, the doctor said that the research strictly followed the project protocol authorized by Conep. “We have the original project approved showing point to point,” he said.

President Jair Bolsonaro (PL) touted proxalutamide as a “new chloroquine”. According to experts heard by the report, the drug is not indicated for Covid-19 because it has been ineffective.

Another research mentioned in the technical note was carried out with ivermectin in Itajaí (SC). The aim of the study was to evaluate the effectiveness of the drug when used as prophylaxis for Covid – the so-called early treatment.

According to Angotti, “More recent data suggest a possible effect on the prophylactic use of drugs (Kerr, 2021; Kerr, 2022)”. “This fact indicates the need to consider pre-exposure and post-exposure prophylaxis in future efforts to develop Therapeutic Guidelines or similar instruments.”

The study listed was led by physician Lucy Kerr and also had the participation of Cadegiani.

The supposed beneficial result of the work circulated on social networks after a TV commentator stated that the SUS had released a study proving that the preventive use of ivermectin had reduced the number of deaths from Covid in Itajaí by 46%.

The viralization took place after the results of the research were published at a conference organized by the Associação Médicos Pela Vida, which maintains a website favorable to early treatment.

In a note to leafKerr stated that the article was peer-reviewed by a scientific journal.

“The Cureus journal does not accept funding from the pharmaceutical industry and is already part of PubMed. If you think that the article was poorly written, that it has methodological flaws, it is not with me that you have to argue, but with the Cureus reviewers. you will get the answer you want”, said the doctor.

Cadegiani, in turn, admitted that the published study does not show the amounts of ivermectin administered, nor does it prove the effectiveness of the drug. “In that population, in that period, it seems to have helped. Period”, said the doctor, in a note.

“As a scientist, it’s impossible for me to say that this ‘proves’. Also, there were no vaccines back then. Now it’s a different story, and I hope we never need drugs or treatments for Covid-19 again, as vaccines improve and resistance to them drops,” said Cadegiani.

Angotti even cited an article written by himself, in partnership with the Secretary of Labor Management and Education of the Ministry of Health, Mayra Pinheiro, known as “Captain Chloroquine”.

The text titled “Pandemic Analysis and Bioethical Considerations for Early Treatment” says that drugs such as hydroxychloroquine, dexamethasone, azithromycin, ivermectin and nitazoxanide have a safety profile and data known for decades.

“Given the evidence present in an emergency scenario, with a potentially lethal disease capable of generating a huge impact on the health system and quality of life, not providing minimally equitable care means, informing and allowing early treatment for all who so desire, can configure injustice (Angotti Neto, 2021)”, wrote the secretary.

Specialists and medical societies that participated in the elaboration of the Conitec document are preparing an appeal to the ministry to reverse Angotti’s decision.

It must be signed by Amib (Association of Brazilian Intensive Medicine), SBI (Brazilian Society of Infectious Diseases), SBPT (Brazilian Society of Pulmonology and Tisiology) and AMB (Brazilian Medical Association).

This Thursday (3), the MPF recommended the revocation of Angotti’s note. According to the agency, the regulation contradicts themes already pacified by the scientific community.

The Attorney General’s Office in the Federal District also asked the secretary to publish the approved guidelines. The government has ten days to position itself on the matter.