The Prevent Senior research that investigated whether hydroxychloroquine and azithromycin were effective in reducing hospitalizations of patients suspected of Covid-19 has again come under criticism.
In a study published last Tuesday (28), in the journal Developing World Bioethics, questions are raised regarding the design of the study.
When contacted, Prevent Senior stated that it “has already acknowledged, on several occasions and in interviews with its representatives to Sheet and other media, there is no proof and scientific evidence in the mentioned work”.
The Prevent Senior study was released in a pre-print article – that is, without peer review. According to the company’s publication, 636 patients with flu symptoms participated in the study. Of these, 412 used azithromycin and hydroxychloroquine — which make up the so-called Covid kit, drugs with no proven effectiveness against the disease — and 224 refused the drugs.
The problem is that, according to the recently published article, the participation data are different from those provided to bodies responsible for regulating clinical trials.
In Plataforma Brasil, a space dedicated to clinical research information from Conep (National Research Ethics Commission), and in ClinicalTrials, a system for registering clinical trials in the United States, it is said that the Prevent Senior research had 200 participants.
Another problem found is that the study was registered on Plataforma Brasil three days before the pre-print version of the research was published.
In the pre-print, the authors of the research point to the conclusion that “empirical treatment with hydroxychloroquine associated with azithromycin for suspected cases of Covid-19 infection reduces the need for hospitalization”.
“The big problem with the project is that it is extremely flawed, from a methodological point of view, but even so, a result is reported that would not be able to be confirmed with this type of research that they did”, says Fernando Hellmann, professor at the Department of Health Public at UFSC (Federal University of Santa Catarina).
Among the methodology problems is the faulty division between control and experimental groups. “The control group is those who didn’t want a Covid kit, but it should be a placebo, because then they could say that it reduces or not the need for hospitalization.”
The open points of the study methodology make it impossible to affirm an association between the drugs and the reduction in hospitalization of patients with Covid. “A causal relationship was created when there was no way to reach that conclusion given the weaknesses of the project”, says the professor.
The article signed by Hellmann also addresses the revelations of the CPIs carried out on Prevent Senior. There were two investigations: one in Brasília and the other at the São Paulo City Council.
One of these revelations was the statements of doctors, to the CPI da Pandemia, that the company’s management advised the clinical staff not to inform patients and relatives about carrying out the studies with the Covid kit.
After the various complaints, an agreement was signed between the company and the Public Ministry of São Paulo in which the company’s obligation to stop prescribing chloroquine to patients diagnosed with coronavirus infection was made official.
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