Posted on 12/09/2022 9:19:11 PM PST by SeekAndFind
The U.S. Food and Drug Administration (FDA) says a drug called ivermectin does not work against COVID-19 but links to studies that show it does, an Epoch Times review has found.
Ivermectin tablets packaged for human use.
The FDA’s website states, “Currently available data do not show ivermectin is effective against COVID-19.”
But half of the studies to which the FDA points support using ivermectin against COVID-19, according to the review.
The papers cut against the drug agency’s repeated exhortations for people not to take ivermectin for COVID-19. In Twitter posts, public statements, and emails, FDA officials have repeatedly warned against ivermectin. Some of those statements triggered a lawsuit from doctors who say the agency’s role is to approve drugs, not to issue recommendations. The suit was dismissed this week.
Dr. Pierre Kory, who frequently prescribes ivermectin for COVID-19 and co-authored a meta-analysis that concluded the drug is effective against the illness, told The Epoch Times that the government’s position on ivermectin “is one of the most glaring examples of the corruption of modern evidence based medicine.”
“There’s one message they want everyone to understand. And that message is that ivermectin doesn’t work,” Kory said. “That’s not a scientific conclusion, that’s theirs. That’s their perverted and distorted interpretation of the data.”
The FDA’s media office did not respond to a request for comment.
Dr. Janet Woodcock, a top official at the agency who was its commissioner from January 2021 to February 2022, told The Epoch Times via email that “ivermectin has been shown to be ineffective against COVID in large randomized trials.”
The FDA’s website points to a U.S. National Library of Medicine database of studies analyzing ivermectin against COVID-19. There are 88 studies listed in the database.
Out of studies that are listed, have been completed, and have results reported, most show or indicate ivermectin effectively combats or prevents COVID-19, according to the review by The Epoch Times.
They include papers reporting on results from randomized, controlled trials, which are often offered as the highest level of evidence by U.S. government officials. Such trials feature a group that receives a placebo and a group that receives the drug, randomization into groups, and blinding, or shielding operators and/or patients from the knowledge of which participants are receiving ivermectin.
Among the papers is a randomized, blinded, controlled trial that found people who received ivermectin and doxycycline, an antibiotic, recovered faster from COVID-19 than those who received a placebo.
Bangladeshi researchers reported the results from the trial of 363 participants on May 13, 2021, in the Journal of International Medical Research.
“Patients with mild-to-moderate COVID-19 infection treated with ivermectin plus doxycycline recovered earlier, were less likely to progress to more serious disease, and were more likely to be COVID-19 negative by RT-PCR on day 14,” they said. PCR has been used to test for COVID-19.
Another paper, published on July 7, 2022, in the International Journal of Infectious Diseases, found that that ivermectin decreased the level of COVID-19 and its viability. Israeli researchers in the randomized, controlled, open label trial compared 47 patients who received ivermectin against 42 who received placebos and said that “ivermectin significantly reduced the time of viral shedding and affected viral viability when initiated in the first week after evidence of infection.”
“There were lower viral loads and less viable cultures in the ivermectin group, which shows its anti-SARS-CoV-2 activity,” the researchers said. SARS-CoV-2 is a name for the virus that causes COVID-19.
A third paper concluded that a regimen of ivermectin and carrageenan works as a prophylaxis, or preventative medicine. Argentinian researchers found in the observational trial involving 229 health care workers that ivermectin helped prevent COVID-19 infection. A followup study involving nearly 1,200 workers confirmed the results. Both sets were reported in the Journal of Clinical and Biomedical Investigation on Nov. 17, 2020.
Ivermectin “could have saved so many lives,” Héctor Carvallo, one of the researchers, told The Epoch Times via email, adding that “it’s been a crime against mankind to prevent its prescription.”
Some other studies, including the largest ones, either found indications that ivermectin works against COVID-19 but did not achieve statistical significance or found no evidence that ivermectin is effective.
That includes a randomized, controlled, double-blind 2021 study by Mexican researchers that found ivermectin did not significantly impact hospitalization duration or mortality, and a randomized, controlled, double-blind 2022 trial by U.S. researchers that concluded ivermectin did not prevent hypoxemia, hospitalization, or death.
Scientists in Australia in April 2020 found that ivermectin worked well against the COVID-19 virus in cell culture, prompting doctors in multiple countries, including Peru and the United States, to start using it against the new illness.
Ivermectin is approved by the FDA to treat parasites. One version is used on horses and other animals.
The FDA quickly warned against using the animal form and said that people should “not take any form of ivermectin unless it has been prescribed to them by a licensed health care provider and is obtained through a legitimate source.”
Studies later in the year suggested ivermectin worked well in humans who had COVID-19, including halting the progression of disease (pdf), helping patients improve faster, and preventing COVID-19 infection, though other studies returned results that did not support ivermectin as a treatment.
The FDA maintained its stance against COVID-19, and created a new web page on March 5, 2021. It initially said, “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.”
In August 2021, the FDA urged people against using ivermectin by telling them that “you are not a horse.” It linked to the page, which was updated the following month with the language it now contains about data not showing ivermectin is effective.
American doctors are allowed to prescribe drugs approved for one use for a different use, a practice known as off-label. But doctors who prescribed ivermectin soon found that many pharmacies stopped filling prescriptions, citing advice from the FDA and other U.S. government bodies.
The FDA does not cite studies on its website to support its statement that data “do not show ivermectin is effective against COVID-19.”
“Clinical trials assessing ivermectin tablets for the prevention or treatment of COVID-19 in people are ongoing,” the agency adds, providing a link to the U.S. National Library of Medicine’s database.
Of the 88 studies listed there, 56 fall under one of three categories: have not been completed, were completed but results have not been reported, or were completed and have since been retracted or otherwise withdrawn.
Of the remaining 32, 16 found or indicate ivermectin is effective as a COVID-19 treatment or prophylactic, according to the Epoch Times review.
Two of the trials were randomized, controlled, and blinded. Nine others were randomized and controlled but were not blinded at all. Most of the rest were observational, meaning they analyzed data from real-world settings like hospitals, or used observational data to create what’s known as a synthetic control group.
The set of papers includes results of a randomized, controlled, open label observational trial (pdf) that found ivermectin combined with doxycycline, an antibiotic, reduced the time to recovery and the mortality rate, and a randomized, controlled, double-blinded trial that found ivermectin and doxycycline quickened recovery and patients were less likely to see their disease progress.
Of the 16 other studies, six reported mixed results. For instance, Spanish researchers reported in The Lancet in February 2021 that ivermectin did not have an impact on testing results, but that there was “a marked reduction” of self-reported symptoms such as loss of smell and cough, and lower levels of viral loads. The result “warrants assessment in larger trials,” the researchers said.
The remaining 10 studies returned results that did not favor ivermectin or did not achieve statistical significance.
U.S. researchers, for example, found that ivermectin probably worked better than a placebo, but that the results did not achieve statistical significance, prompting them to say in October that “this study adds to the growing evidence that there is not a clinically relevant treatment effect of ivermectin at this dose and duration.”
The FDA did not respond to a request for comment on the revelation that half of the studies it points to support using ivermectin (IVM) against COVID-19.
Woodcock, the FDA’s principal deputy commissioner, reviewed the studies. She was unimpressed.
The Bangladeshi trial, for instance, was criticized for primarily including young persons, and having a higher number of dropouts in the placebo arm. Woodcock said the Israeli study did not report “clinical outcomes” and noted many of the other papers had small numbers of participants.
“There are only a couple studies here that really look at the effects of IVM and see a positive clinical effect and they are much smaller than the negative studies,” Woodcock told The Epoch Times in an email.
The trials in favor of ivermectin are on the smaller side, and more likely to be observational. But that doesn’t necessarily mean they are inferior, Kory said. He cited research that found there was little difference between observational studies and randomized-controlled trials, as well as a paper that said “study design is only one factor that determines study quality.”
The FDA isn’t the only government group opposed to using ivermectin to treat COVID-19. The National Institutes of Health (NIH) COVID-19 Treatment Guidelines Panel recommends against it, citing several of the larger trials that found little or no benefit for ivermectin. The panel cites none of the papers that found a positive effect.
Read more here...
I’ve seen it work I’ve had Doctors tell me it works. And it’s essentially harmless used properly vs the Covid injection or paxlovid and certainly has greater safety profile than remdesivir or a ventilator! This is handiwork of very evil people that want you to die. So it’s not ’approved’? ‘researched’? Neither is the friggin mRNA injection!! Dr’s prescribe a multitude of medications for off label use EVERY DAY and a multitude of medications prescribed incorrectly or for misuse (antibiotic abuse, long term use of proton pump inhibitors to name a couple)-get the heck over it and bring back medical freedom!! This is heinous abuse of power!! Hell will be too good for these satanic people
Thanks for posting.... Ivermectin has been proven effective in killing off the Covid crap....while the CDC, Fauci, MSM and our government have been proven effective in KILLING OFF AMERICAN PEOPLE!! imho
Elsevier Fighting viruses with antibiotics: an overlooked path
From 2012. Again note the date and the info on Ivermectin...
I could post additional studies going back years.
Deep State, Big Med, Big Pharma all knew about therapeutics, including Ivermectin.
But CoupFlu policy has NEVER been about protecting public health.
From that last link above, the one from 2012...
...Ivermectin exerts its effect at a timepoint that coincides with the onset of intracellular viral RNA synthesis, as expected for a molecule that specifically targets the viral helicase...
Now let's fast forward, shall we, to a link from 2020...
Should We Try SARS-CoV-2 Helicase Inhibitors for COVID-19 Therapy?
I won't print the rest of what I'm thinking.
All you have to do is check the death rate in Nigeria…
Ivermectin slows spread of river blindness in Nigeria; could interrupt West Nile transmission in US
Nonpharmaceutical Measures for Pandemic Influenza in Nonhealthcare Settings—Personal Protective and Environmental Measures
While this study came out in May 2020 (and the researchers were based in Hong Kong), it is actually a summary of 14 studies predating the pandemic, measuring the effectiveness of personal protective measures and environmental hygiene measures in nonhealthcare settings.
The bottom line - evidence from 14 randomized controlled trials of these measures did not support a substantial effect on transmission of laboratory-confirmed influenza. We similarly found limited evidence on the effectiveness of improved hygiene and environmental cleaning.
For me, the real telling point was from the ONE study, held in Cairo, where hand washing was correlated with lower incidence of influenza, but only when the subjects were children being subjected to sustained and overbearing statism:
An intensive campaign to promote hand hygiene was launched in the intervention schools to raise the awareness of students, teachers, nurses, and parents regarding the importance of hand hygiene and to increase the proportion of students washing their hands. Hand hygiene teams required students in the first 3 primary grades to wash their hands at least twice during the school day for ≈45 seconds, followed by proper rinsing and drying with a clean cloth towel.
Campaign materials were developed for 3 groups (students, teachers, parents). The teachers’ guidebook included a detailed description of the students’ activities and methods to encourage students to practice these activities. Posters were placed near sinks in the classrooms and on the playground. The primary message was to wash hands with soap and water upon arriving at school, before and after meals, after using the bathroom, and after coughing or sneezing.
Grade-specific student booklets were developed; each included a set of 12 games and fun activities that promoted handwashing. At least 1 activity was used each week. A special song to promote hand hygiene was developed and played regularly at schools. Informational fliers were distributed to parents to reinforce the messages delivered at the schools. Many schools were creative in motivating students to comply with washing hands, such as selecting a weekly hand hygiene champion, developing theater plays, and launching school contests for drawings and songs.
School Teams At each intervention school, a hand hygiene team composed of 3 teachers (social studies, arts, sports) and the school nurse was established. The hand hygiene team ensured that all predesigned activities for the hand hygiene campaign were implemented on a weekly basis (Table 1). The school nurses and teachers were trained to interview students, collect absenteeism data, interview parents, and complete data collection forms, and the nurses were trained to collect and process nasal swabs to test for influenza. At control schools, the nurses were supported by a single surveillance officer who was assigned to complete data collection forms.
Basically. hand washing works only if Big Brother is watching, threatening, and shaming you like a child..which is was what they tried.
They knew.
Government is full of political morons
Six to eight weeks seems like a long span, between doses.
Has FLCCC updated their preventative protocol?
Thx.
P
I took the vaccine and a booster and I am still alive and well even after Covid.
Dr. Zelenko (RIP) treated over 1000 with only a handful of deaths, because he used zinc. I suspect most of the other studies omitted zinc as well.
Unfortunately, there are folks who did not share your good fortune.
Congratulations! I'm sure you thanked God for this.
Wife and I got the WuFlu and followed the FLCCC Alliance protocol. We recovered in 5 days. Early (immediate) treatment makes a big difference.
“Unfortunately, there are folks who did not share your good fortune.”
I don’t know any of those people. I know people in their 90’s who survived Covid yet my sister(couldn’t get the vaccine) ended up in the ICU and my college roommate(unvaxxed) died from it. It’s a strange bioweapon.
As best I can tell, if you try to beat Covid, you can do it. I’ve been doing a prophylaxis since Covid started and I stay away from people.
I live in the woods with my husband who works from home. Social distancing has been a life style for about 7 years. On average, very two months is when I visit the big city. Your mileage may vary. Haven’t kept up to date with FLCCC, sorry.
thanks for that.
I looked at the first 2 “not supportive” trials.
The 1st mentions ivermectin doseage but not frequencey...don’t know how long it was given.
The 2nd proclaims “the duration of symptoms was not significantly different...”
yet in every category, ivermectin treated patients were less affected...
exception: organ failure was 2 for ivermetcin treated and 2 for placebo.
I stopped looking after this...
Fauci’s lap dogs
They did this BEFORE Biden
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