All the below links are in English. Excerpts are on our own.
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Science and Technology Vol.70 (coronavirus drugs)
Why You Should Not Use Ivermectin to Treat or Prevent COVID-19 (03/05/2021) | @US_FDA
…The FDA’s job is to carefully evaluate the scientific data on a drug to be sure that it is both safe and effective for a particular use, and then to decide whether or not to approve it. …
There seems to be a growing interest in a drug called ivermectin to treat humans with COVID-19. Ivermectin is often used in the U.S. to treat or prevent parasites in animals. The FDA has received multiple reports of patients who have required medical support and been hospitalized after self-medicating with ivermectin intended for horses.
When Can Taking Ivermectin Be Unsafe?
The FDA has not reviewed data to support use of ivermectin in COVID-19 patients to treat or to prevent COVID-19; however, some initial research is underway. Taking a drug for an unapproved use can be very dangerous. This is true of ivermectin, too.
There’s a lot of misinformation around, and you may have heard that it’s okay to take large doses of ivermectin. That is wrong.
Even the levels of ivermectin for approved uses can interact with other medications, like blood-thinners. You can also overdose on ivermectin, which can cause nausea, vomiting, diarrhea, hypotension (low blood pressure), allergic reactions (itching and hives), dizziness, ataxia (problems with balance), seizures, coma and even death.
Ivermectin Products for Animals Are Different from Ivermectin Products for People
… Moreover, FDA reviews drugs not just for safety and effectiveness of the active ingredients, but also for the inactive ingredients. Many inactive ingredients found in animal products aren’t evaluated for use in people. Or they are included in much greater quantity than those used in people. In some cases, we don’t know how those inactive ingredients will affect how ivermectin is absorbed in the human body. …
Fact check: Ivermectin is not a proven treatment for COVID-19 (08/14/2021) | @USATODAY
Ivermectin not proven to treat COVID-19
… Some limited studies have suggested ivermectin could help treat COVID-19. But other, more rigorous research has found little or no impact.
“The reason for the interest in ivermectin is that studies in the lab have shown it can block viruses from multiplying in experimental settings – i.e. in a petri dish – and so people hoped this would mean it could help treat COVID-19 in people too,” Dr. Denise McCulloch, an infectious disease specialist with the University of Washington’s School of Medicine, said in an email. “Unfortunately, the few high-quality studies that have been done to date do not demonstrate a beneficial effect of ivermectin when it is used in people with COVID-19.” …
A peer-reviewed meta-analysis of 15 trials, published in the July/August issue of the American Journal of Therapeutics, found that “large reductions in COVID-19 deaths are possible using ivermectin.” But experts told PolitiFact, an independent fact-checking outlet, that some of the trials the study included were not high-quality, and some of its authors were affiliated with a pro-ivermectin group. …
“To extrapolate from how much drug is needed to work in the test tube to how much is required to work in a human being against the virus makes these trials and all the meta-reviews published less than worthless – it’s dangerous,” Dr. Benhur Lee, a microbiology professor at Mount Sinai’s Icahn School of Medicine, said in an email. …
Officials say drug should ‘only be used within clinical trials’
… The FDA said in April 2020 that people should not take ivermectin unless it’s “prescribed to them by a licensed health care provider and is obtained through a legitimate source.” The agency reiterated that position in March. …
Our fact-check sources
Column: Major study of Ivermectin, the anti-vaccine crowd’s latest COVID drug, finds ‘no effect whatsoever’(08/11/2021) | @latimes
Ivermectin, the latest supposed treatment for COVID-19 being touted by anti-vaccination groups, had “no effect whatsoever” on the disease, according to a large patient study.
That’s the conclusion of the Together Trial… …Edward Mills of McMaster…
… Its repurposing as a COVID treatment began with a 2020 paper by Australian researchers who determined that at extremely high concentrations it showed some efficacy against the SARS-CoV-2 virus, which causes COVID, in the lab. But their research involved concentrations of the drug far beyond what could be achieved, much less tolerated, in the human body. …
Mills said that his team’s Ivermectin trial was altered after advocacy groups complained that it was too modest to achieve the results they expected. The trial originally tested the results from a single Ivermectin dose in January this year, but was later changed to involve one daily dose for three days of 400 micrograms of the drug for every kilogram (about 2.2 pounds) of the patients’ weight, up to 90 kilograms. …
Flawed ivermectin preprint highlights challenges of COVID drug studies: The study’s withdrawal from a preprint platform deals a blow to the anti-parasite drug’s chances as a COVID treatment, researchers say. (02/08/2021) | @nature
… The paper summarized the results of a clinical trial seeming to show that ivermectin can reduce COVID-19 death rates by more than 90% – among the largest studies of the drug’s ability to treat COVID-19 to date. But on 14 July, after internet sleuths raised concerns about plagiarism and data manipulation, the preprint server Research Square withdrew the paper because of “ethical concerns”. …
Early in the pandemic, scientists showed that ivermectin could inhibit the coronavirus SARS-CoV-2 in cells in laboratory studies. But data on ivermectin’s efficacy against COVID-19 in people are still scarce, and study conclusions conflict greatly, making the withdrawal of a major trial particularly noteworthy. …
Ripple effects
…Few therapies can claim such an impressive reduction in death rates. “It was a significant difference, and that stood out,” says Andrew Hill, who studies repurposed drugs at the University of Liverpool, UK. …
One of the authors of the meta-analysis, statistician Andrew Bryant at Newcastle University, UK, says that his team corresponded with Elgazzar before publishing the work to clarify some data. “We had no reason to doubt the integrity of [Professor] Elgazzar,” he said in an e-mail. He added that in a pandemic setting, no one can reanalyse all of the raw data from patient records when writing a review. Bryant went on to say that his group will revise the conclusion if investigations find the study to be unreliable. However, even if the study is removed, the meta-analysis would still show that ivermectin causes a major reduction in deaths from COVID-19, he says. …
Reliable data needed
… Carlos Chaccour, a global-health researcher at the Barcelona Institute for Global Health in Spain, says it has been difficult to conduct rigorous studies on ivermectin. That’s partly because funders and academics in wealthy countries haven’t supported them, and, he suspects, have often dismissed trials of ivermectin because most of them have been done in lower-income countries. Furthermore, says Rodrigo Zoni, a cardiologist at the Corrientes Cardiology Institute in Argentina, it is difficult to recruit participants because many people – particularly in Latin America – are already taking the widely available drug in an attempt to prevent COVID-19. …
Adding to the difficulty are conspiracy theories holding that ivermectin has been proven to work and that drug companies are depriving the public of a cheap cure. Chaccour says he has been called ‘genocidal’ for doing research on the drug rather than just endorsing it.
…Gideon Meyerowitz-Katz, an epidemiologist at the University of Wollongong in Australia…It’s not yet possible to assess whether ivermectin works against COVID-19 because the data currently available are not of sufficiently high quality…
Chaccour and others studying ivermectin say that proof of whether the drug is effective against COVID-19 rests on a handful of large, ongoing studies, including a trial in Brazil with more than 3,500 participants. By the end of 2021, says Zoni, around 33,000 people will have participated in some kind of ivermectin trial. …
Ivermectin: why a potential COVID treatment isn’t recommended for use: The antiparasitic drug was thought to be a potential treatment for COVID-19, but there isn’t sufficient evidence to recommend its use, despite widespread support online. (22/04/2021) | @gavi
WHAT IS IVERMECTIN?
… In humans, ivermectin is currently prescribed in tablet form to treat certain roundworm infections that cause illnesses such as river blindness. It may also be applied as a cream to control the common inflammatory skin condition papulopustular rosacea.
But ivermectin is most commonly used for veterinary parasitic diseases, especially gastrointestinal worm infestations. Consequently, it is readily available and relatively inexpensive. …
WHY MIGHT IT BE USED TO TREAT COVID?
… In early 2020, a paper was made public (before it was reviewed by other scientists) which showed ivermectin suppresses the replication of the SARS-CoV-2 virus, which causes COVID-19, under laboratory conditions. This was one of many studies over the past 50 years to show that the antiparisitic drug could also have antiviral uses.
There appear to be two key ways in which the drug could prevent coronavirus replication. First, it could prevent the virus from suppressing our cells’ natural antiviral responses. Second, it’s possible the drug prevents the “spike” protein on the surface of the virus from binding to the receptors that allow it to enter our cells. Along with the anti-inflammatory actions apparent from ivermectin’s efficacy in rosacea, these may point towards useful effects in a viral disease that causes significant inflammation. …
WHY IS IT CONTROVERSIAL?
… A controversy subsequently blew up over an article by the Front Line COVID-19 Critical Care Alliance, a group of doctors and researchers that lobbies for the use of ivermectin.
This article, summarising multiple small studies of the effects of ivermectin on COVID-19 patients, was provisionally accepted for publication in the journal Frontiers in Pharmacology in January 2021 but then rejected and removed from the journal’s website in March. The journal’s editor stated that the standard of evidence in the paper was insufficient and that the authors were inappropriately promoting their own ivermectin-based treatment. …
WHY ISN’T IT RECOMMENDED?
… More studies are underway. A large, multicentre trial began in February to determine the effectiveness of ivermectin as well as metformin (an anti-diabetes medication) and fluvoxamine (an antidepressant) in preventing COVID-19 disease progression. …
Ivermectin to be investigated as a possible treatment for COVID-19 in Oxford’s PRINCIPLE trial (23/06/2021) | @UniofOxford
EMA advises against use of ivermectin for the prevention or treatment of COVID-19 outside randomised clinical trials (22/03/2021) | @EMA_News
Don’t use ivermectin to treat COVID, Coast health officials warn after one hospitalized (08/13/2021) | @sunherald