CLAIM
Ivermectin reduces the risk of death from COVID-19
DETAILS
No support: There is no scientific evidence to demonstrate that ivermectin is effective in treating patients with COVID-19. The safety profile of ivermectin is established only for the treatment of parasitic infection, not for the treatment of viruses, including the one that causes COVID-19.
Erroneous: There are design flaws and methodological limitations in clinical studies that support the use of ivermectin against COVID-19. However, the video presented these studies as guaranteed proof that ivermectin is an effective treatment for patients with Covid-19, while disregarding the latest studies showing that ivermectin has no beneficial effects for patients with COVID-19.
LEAD FROM THE KEY
Scientific evidence does not support the use of ivermectin as a treatment for COVID-19. Clinical trials must be designed and carried out in an appropriate manner to demonstrate the efficacy and safety of a particular drug in the treatment of a specific disease. Clinical trials showing beneficial effects of using ivermectin to treat patients with COVID-19 often have many methodological deficiencies and design flaws. More recent and well-planned studies show that ivermectin is ineffective for the treatment of patients with COVID-19. In addition, safety data related to the use of ivermectin antiparasitic drugs does not apply to their safety in COVID-19 patients.
COMPLETE COMPLAINT: Ivermectin reduces the risk of death from COVID-19
REVIEW
A YouTube video published on March 6, 2021 featured doctor Tess Lawrie, who said that ivermectin reduces the risk of death from COVID-19. This statement was based on a meta-analysis and review that Lawrie conducted using 27 scientific studies summarized in a review by an organization called Front Line COVID-19 Critical Care Alliance (FLCCC). The video received more than 140,000 views on YouTube at the time of this writing.
Ivermectin is an FDA approved drug for the treatment of parasitic infections, however, many have recommended its use to treat COVID-19, which is caused by a virus. Its antiviral efficacy has not been demonstrated in people, but in vitro studies, which are carried out outside living organisms, have shown that ivermectin has antiviral activity against some viruses, such as dengue[1] and the Zika virus[2]. In vitro studies generally involve artificial conditions that do not represent conditions in the human body.
Clinical trials on the effectiveness of ivermectin against COVID-19 have also been carried out, some of which have in fact been published and included in Lawrie’s meta-analysis. However, there are several problems with Lawrie’s meta-analysis. It was not peer-reviewed, unlike studies published in scientific journals, and several of the studies used by the FLCCC and included in Lawrie’s review were also not peer-reviewed.[3-5].
The lack of peer review means that scientists with relevant experience, such as epidemiologists and biostatistics, have not independently reviewed the research. Peer review is an important step in the scientific publication process, as it helps authors to identify and correct substantial errors or deficiencies in their studies. It can also help to determine the quality of a particular study. For example, some publications may contain very strong scientific evidence and new discoveries, while others may have only weak research to support their hypotheses. In general, peer review can help prevent the spread of exaggerated or unsupported scientific claims.
Both Lawrie and the FLCCC cited three ongoing clinical trials testing the effects of ivermectin as a treatment for COVID-19 that produced inconclusive results, as well as a report by Juan Chamie, a data analyst with no training in biology or medicine. Overall, presenting these studies and clinical trials as evidence of the effectiveness of ivermectin as a treatment for COVID-19 without recognizing its limitations is inaccurate and misleading.
A summary of the results and limitations of some clinical studies on the effects of ivermectin on COVID-19 is available on the US National Institutes of Health’s COVID-19 Treatment Guidelines website. For example, some limitations of these clinical studies included a small sample and vague definitions of the severity of the disease. For example, if the severity of symptoms is poorly defined, it becomes difficult to objectively assess the level of improvement provided by drug treatment, if any.
In addition, some studies have had no placebo control. Without a placebo control, we cannot exclude the bias created by the placebo effect. The placebo effect occurs when a participant’s belief that he is receiving effective treatment has a positive effect on his symptoms, even if he has received a placebo with no active effect on his illness. In addition, some of the studies would be based on observations, which were not statistically significant, that is, it could not be excluded that all results occurred only by chance.
The focus on ivermectin as a potential drug against COVID-19 started with an in vitro study published by Caly et al. in 2020 showed that ivermectin had antiviral effects against the virus that causes COVID-19, SARS-CoV-2, in cell cultures[6]. Although this result provided researchers with a justification for continuing drug studies, this study itself did not provide evidence of the clinical efficacy of ivermectin against COVID-19. In addition, the study used very high concentrations of ivermectin that were many times higher than the doses approved for use in people[6].
Contrary to the video, a double-blind, placebo-controlled study by López-Medina et al. showed that ivermectin is unlikely to be effective in patients with mild COVID-19[7]. This study was well designed and does not have many of the limitations present in the clinical trials cited in Lawrie’s meta-analysis. As this study was double-blind, neither the study participants nor the researchers knew whether they had received or administered the placebo or the drug being tested. This design helps to eliminate prejudice. That said, the authors concluded that larger studies need to be carried out to better understand the effect of ivermectin on COVID-19.
The video also misleads viewers by suggesting that safety data related to the use of a drug for one purpose apply to different uses. Although scientists have known ivermectin for more than forty years and it has been used to treat parasitic infections, this is not relevant to the safety of ivermectin in patients with COVID-19. The safety profile of a drug in a situation does not automatically prove that it is safe for patients with a different disease. Therefore, it is misleading to say that ivermectin is safe for patients with COVID-19.
In general, due to the lack of evidence to support the efficacy and safety of ivermectin, the Food and Drug Administration does not recommend the use of ivermectin for COVID-19. The Infectious Diseases Society of America also does not recommend the use of ivermectin against COVID-19.
In the video, Lawrie also discussed the accessibility of ivermectin and how it can be produced easily and massively. Some have argued that the reason why ivermectin is not being used against COVID-19 is that it is cheap and would not generate as much profit for pharmaceutical companies. At the same time, we can conclude that an inexpensive, therefore widely accessible, drug that would be administered to tens to hundreds of millions worldwide, would be an extremely profitable business. Interestingly, the manufacturer of ivermectin (under the brand name Strocemol) Merck does not recommend its use against Covid-19 due to the lack of scientific evidence and safety data.
On March 22, 2021, the European Medicines Agency released a statement advising against the use of ivermectin for the prevention or treatment of COVID-19 outside of randomized controlled trials.