As the Covid-19 epidemic picks up momentum, a new study on ivermectin, this pesticide used against scabies, is of interest for the anti-vaccine sphere. Released on August 31, 2022 on the Cureus open access platform, it has become popular again in recent days. From a sample of 88,012 people, a team of Brazilian researchers concluded that regular use of ivermectin for Covid-19 prophylaxis led to a 92% reduction in the death rate linked to Covid-19.
EXPLOSIVE STUDY! IVERMECTIN WAS 92% EFFECTIVE AGAINST COVID!
The study, published August 31 in the Cuerus Journal of Medical Science, was conducted through an observational study on a strictly controlled population of 88,012 subjects in the Brazilian city of Itajaí. pic.twitter.com/PiGrMXPDLb– Eliie (@ eliie1757) September 24, 2022
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On social networks, this “explosive”, “peer-reviewed” study was reprized to claim that “” ivermectin was 92% effective “against Covid-19. Other Internet users are wondering why the drug “is not yet approved”.
FALSE
But there is nothing explosive about this observational study: “It sucks. This is the zero level of pharmacoepidemiology “, indigns Mathieu Molimard, professor in the department of medical pharmacology at the university hospital of Bordeaux and member of the scientific council of the site of the French Society of Pharmacology and Therapy (SFPT).
The reason for this anger? An immortal “huge” time distortion, which is a factor that can distort the results. A “massive” prejudice, also noted by Dominique Costagliola, research director of Inserm, specialized in epidemiology. Behind this name there is a problem of temporality in the conduct of the study, which derives from a wrong methodological choice.
A group of 70,000 people excluded from the study
So, according to the definition of European Academy of Patients on Therapeutic Innovation (Eupati), this immortal time distortion means that participants in the treatment arm “will only be monitored if they do not have the symptoms that the treatment is intended to prevent for the duration of the delay. Any participant for whom this is not the case will be excluded from the study, which means that the treatment arm is selected on a different basis than the “placebo arm” or the comparator group without treatment, known as the control group.
In the case of the Brazilian study, conducted in Itajai, a city in the south-east of the country, the protocol is as follows: for a person weighing 60 kg, 24 mg of ivemectin was taken two days in a row every fortnight for five months , between July and December 2020. Out of a population of 113,844 people who were administered ivermectin, three groups are considered: irregular users, i.e. those who took less than 60 mg of ivermectin, or 33,971 people, those who took more than 180 mg, or 8,325 people (the treatment arm) and a group between 60 mg and 180 mg, consisting of 71,548 people and not being tested (without knowing why). The control group consisted of 45,716 inhabitants, who did not receive ivermectin.
A “one month” shooting window.
However, to reach 180 mg, it needs to last at least three and a half months, notes Mathieu Molimard. “If you took Covid at two months, you are not in the group that was treated with ivermectin, as you did not have 180 mg, you are in the rejected group. The treated group of 8,325 people can only be analyzed “in the period from the fourth to the fifth month”. “Since the study lasts five months and you must have taken 180 mg, we only have a one-month window of opportunity to analyze 8,000 people who are compared to a five-month window of opportunity for the others,” he explains. The results are therefore skewed, he says.
What should have been done to make the studio work? “The 70,000 patients should have been taken into account in the results, examined during the study, emphasizes Mathieu Molimard. From D + 1, if the patient is in the treatment arm and an event occurs, it remains there. And yes, I think we correct almost everything. “
Conflict of interest
Furthermore, the pharmacologist believes the review was not “serious”. The peer review began on August 22nd and ended on August 27th, a far too short time: “There are at least 15 days to go”, he underlines. “There is a real problem,” he warns. If the revision had been done, they would have talked about immortal time warp. ” Conflict of interest the authors are also to be raised: several are or have been paid consultants by Vitamedic, producer of ivermectin, or for the Médicos Pela Vida association, which promotes ivermectin as a cure for Covid-19 and opposes vaccination. Others have received grants from the COVID-19 Critical Care Alliance, an association that also defends the use of ivermectin in the prevention of Covid-19.
Cureus, which presents itself as an open access platform for medical publications, is also not part of the list of non-predatory scientific journals which draws up the Sorbonne Faculty of Medicine, and in which “it is considered lawful to publish one’s work”.
“There is no need to continue the search”
“With a 92% reduction in mortality from ivermectin, the difference is too big to be true,” adds Mathieu Molimard. If true, it would result in a clinical study. However, this is not what clinical trials are up to now. Published on August 18, 2022 in New England Journal of MedicineA randomized study of people taking metformin (an antidiabetic), ivermectin or fluvoxamine (an antidepressant), before going to the emergency room or hospitalizations related to Covid, did not conclude that these three drugs against the virus.
“There is no need to continue research in the field of ivermectin and Covid, because the doses to be reached in humans to reproduce their effects in vitro are unattainable and all the not too shaky studies are negative,” he explains, on the part his, Dominique Costagliola, research director at Inserm.
According to the French Society of Pharmacology and Therapy, there are no data to recommend the use of ivermectin to prevent or treat SARS-CoV-2 infection. “The regularly updated meta-analyzes show no efficacy of ivermectin against Covid-19”, also emphasizes Dominique Costagliola.
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