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FDA Says Ivermectin Doesn't Work Against COVID-19 But Points To Studies That Show It Does... WHOOPS!
Epoch Times ^ | 12/09/2022 | Zachary Steiber

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.”

Studies

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.

FDA Intervention

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.

Studies on Ivermectin Against COVID-19DateJournalParticipantsOutcome
Effects of Ivermectin-azithromycin-cholecalciferol combined therapy on COVID-19 infected patients: A proof of concept study2020Biomedical Research35Positive
Effectiveness of Ivermectin as add-on Therapy in COVID-19 ManagementJuly 8, 2020Preprint87Positive
Safety and Efficacy of the Combined Use of Ivermectin, Dexamethasone, Enoxaparin and Aspirin Against COVID-19Sept. 15, 2020Preprint167Positive
Study of the Efficacy and Safety of Topical Ivermectin + Iota-Carrageenan in the Prophylaxis against COVID-19 in Health PersonnelNov. 17, 2020Journal of Biomedical Research and Clinical Investigation229Positive
Use of Ivermectin as a Potential Chemoprophylaxis for COVID-19 in Egypt: A Randomised Clinical TrialFeb. 1, 2021Journal of Clinical and Diagnostic Research203 contacts to 52 index casesPositive
Efficacy of Ivermectin in COVID-19 Patients with Mild to Moderate DiseaseFeb. 5, 2021Preprint86Positive
A Comparative Study on Ivermectin-Doxycycline and Hydroxychloroquine-Azithromycin Therapy on COVID-19 PatientsFeb. 25, 2021Eurasian Journal of Medicine and Oncology116Positive
Ivermectin in combination with doxycycline for treating COVID-19 symptoms: a randomized trialMay 2021International Journal of International Medical Research363Positive
Effect of a combination of nitazoxanide, ribavirin, and ivermectin plus zinc supplement (MANS.NRIZ study) on the clearance of mild COVID‐19May 2021Journal of Medical Virology113Positive
Controlled Randomized Clinical Trial on Using Ivermectin with Doxycycline for Treating COVID-19 Patients in Baghdad, IraqMay 6, 2021Iraqi Journal of Medical Sciences140Positive
Clinical, Biochemical and Molecular Evaluations of Ivermectin Mucoadhesive Nanosuspension Nasal Spray in Reducing Upper Respiratory Symptoms of Mild COVID-19June 15, 2021International Journal of Nanomedicine114Positive
Ivermectin as a SARS-CoV-2 Pre-Exposure Prophylaxis Method in Healthcare Workers: A Propensity Score-Matched Retrospective Cohort StudyAug. 13, 2021Cureus271Positive
Intensive Treatment With Ivermectin and Iota-Carrageenan as Pre-exposure Prophylaxis for COVID-19 in Health Care Workers From Tucuman, ArgentinaSept-Oct, 2021American Journal of Therapeutics234Positive
Effectiveness of ivermectin-based multidrug therapy in severely hypoxic, ambulatory COVID-19 patientsFeb. 9, 2022Future Microbiology24Positive
Randomized trials – Ivermectin repurposing for COVID-19 treatment of outpatients with mild disease in primary health care centersJune 21, 2022Research, Society and Development254Positive
The effect of ivermectin on the viral load and culture viability in early treatment of nonhospitalized patients with mild COVID-19 – a double-blind, randomized placebo-controlled trialJuly 7, 2022International Journal of Infectious Diseases89Positive
The effect of early treatment with ivermectin on viral load, symptoms and humoral response in patients with non-severe COVID-19: A pilot, double-blind, placebo-controlled, randomized clinical trialFeb. 1, 2021The Lancet24Mixed
Positive impact of oral hydroxychloroquine and povidone-iodine throat spray for COVID-19 prophylaxis: An open-label randomized trialApril 2021International Journal of Infectious Diseases3037Mixed
Clinical study evaluating the efficacy of ivermectin in COVID-19 treatment: A randomized controlled studyJune 2, 2021Journal of Medical Virology164Mixed
Antiviral effect of high-dose ivermectin in adults with COVID-19: A proof-of-concept randomized trialJuly 1, 2021The Lancet45Mixed
Ivermectin compared with placebo in the clinical evolution of Mexican patients with asymptomatic and mild COVID-19: a randomized clinical trialMay 23, 2022Preprint66Mixed
Efficacy and safety of ivermectin in the treatment of mild to moderate COVID-19 infection: a randomized, double-blind, placebo-controlled trialAug. 26, 2022Trials72Mixed
Efficacy and Safety of Ivermectin and Hydroxychloroquine in Patients with Severe COVID-19: A Randomized Controlled TrialFeb. 23, 2021Infectious Disease Reports106Not Supportive
Effect of Ivermectin on Time to Resolution of Symptoms Among Adults With Mild COVID-19March 4, 2021Journal of American Medical Association476Not Supportive
Evaluation of the effectiveness and safety of adding ivermectin to treatment in severe COVID-19 patientsMay 4, 2021BMC Infectious Diseases66Not Supportive
Ivermectin to prevent hospitalizations in patients with COVID-19 (IVERCOR-COVID19) a randomized, double-blind, placebo-controlled trialJuly 2, 2021BMC Infectious Diseases501Not Supportive
Efficacy of Ivermectin Treatment on Disease Progression Among Adults With Mild to Moderate COVID-19 and ComorbiditiesFeb. 18, 2022Journal of American Medical Association490Not Supportive
Effect of combined use of ivermectin and colchicine in COVID-19 patientsJune 22, 2022Egyptian Journal of Anesthesia135Not Supportive
Pharmacometric assessment of the in vivo antiviral activity of ivermectin in early symptomatic COVID-19July 19, 2022Preprint96Not Supportive
Randomized Trial of Metformin, Ivermectin, and Fluvoxamine for Covid-19Aug. 18, 2022New England Journal of Medicine1323Not Supportive
Ivermectin role in COVID-19 treatment (IRICT): single-center, adaptive, randomized, double-blind, placebo-controlled, clinical trialOct 20, 2022Expert Review of Anti-infective TherapyunclearNot Supportive
Effect of Ivermectin vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19Oct. 25, 2022Journal of American Medical Association1591Not Supportive
Note: Only studies from the database linked to by the FDA that have been completed and have had results released are included

Half of Studies Supportive

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...


TOPICS: Health/Medicine; Science; Society
KEYWORDS: chinavirus; covid; covidinfo; fda; ivermectin; ivrmectinresearch
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To: SeekAndFind

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


21 posted on 12/10/2022 3:55:16 AM PST by dkGba
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To: SeekAndFind

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


22 posted on 12/10/2022 4:02:25 AM PST by high info voter (Delivery )
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To: SeekAndFind; Jane Long; nickcarraway; ransomnote; DoodleBob
From 2016. Note the date, and info on Ivermectin...

Elsevier Fighting viruses with antibiotics: an overlooked path

From 2012. Again note the date and the info on Ivermectin...

Ivermectin is a potent inhibitor of flavivirus replication specifically targeting NS3 helicase activity: new prospects for an old drug

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.

23 posted on 12/10/2022 4:16:09 AM PST by mewzilla (We will never restore the republic if we don't first secure the ballot box.)
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To: mewzilla; nickcarraway; ransomnote; Jane Long; DoodleBob
Okay, one more because this is really pi$$ing me off...

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.

24 posted on 12/10/2022 4:21:07 AM PST by mewzilla (We will never restore the republic if we don't first secure the ballot box.)
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To: mewzilla

All you have to do is check the death rate in Nigeria…


25 posted on 12/10/2022 5:13:08 AM PST by Hojczyk
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To: Libloather
That's were I get. Staff freaked out because it was all over the news. I told them I had worked for a vet and it wouldn't be my first time taking "animal" meds. Used it on my husband when he had Omicron last February. Horse wormer paste and vitamins took care of his systems (except for a mild headache) literally overnight. I take it every 6-8 weeks as a prophylactic because I visit elderly relatives in the big city a few times a year. Never had COVID.

Dosage is by weight noted on the side of the tube. Start with a smaller dose then work your way up because you may experience diarrhea and other die off effects with a first large dose.
26 posted on 12/10/2022 5:18:06 AM PST by neefer (Bad spellers of the world, untie!)
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To: Hojczyk
Speaking of Nigeria, from last year...

Ivermectin slows spread of river blindness in Nigeria; could interrupt West Nile transmission in US

27 posted on 12/10/2022 5:22:17 AM PST by mewzilla (We will never restore the republic if we don't first secure the ballot box.)
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To: mewzilla; nickcarraway; ransomnote; Jane Long
As long as we are getting enraged,

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.

28 posted on 12/10/2022 5:39:16 AM PST by DoodleBob ( Gravity’s waiting period is about 9.8 m/s²)
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To: SeekAndFind

Government is full of political morons


29 posted on 12/10/2022 6:18:28 AM PST by butlerweave
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To: neefer

Six to eight weeks seems like a long span, between doses.

Has FLCCC updated their preventative protocol?

Thx.


30 posted on 12/10/2022 6:41:28 AM PST by Jane Long (What we were told was a “conspiracy theory” in 2020 is now fact. 🙏🏻 Ps 33:12 of day. )
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To: null and void; aragorn; EnigmaticAnomaly; kalee; Kale; AZ .44 MAG; Baynative; bgill; bitt; ...

P


31 posted on 12/10/2022 7:15:03 AM PST by bitt (<img src=' 'width=50%>)
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To: upchuck

I took the vaccine and a booster and I am still alive and well even after Covid.


32 posted on 12/10/2022 7:20:56 AM PST by AppyPappy (Biden told Al Roker "America is back". Unfortunately, he meant back to the 1970's)
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To: SeekAndFind
I checked one of the 'failure' studies. They did not mention zinc as part of the study, which actually stops the virus from replicating, while the IVM is the ionosphore that holds the cell open for the zinc to enter.

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.

33 posted on 12/10/2022 8:18:37 AM PST by RideForever (Damn, another dangling par .....)
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To: AppyPappy
I took the vaccine and a booster and I am still alive and well even after Covid.

Unfortunately, there are folks who did not share your good fortune.

Congratulations! I'm sure you thanked God for this.

34 posted on 12/10/2022 8:36:51 AM PST by upchuck (When you never took the vaccine or boosters: Still alive and healthy with no chance of side effects)
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To: SeekAndFind

Wife and I got the WuFlu and followed the FLCCC Alliance protocol. We recovered in 5 days. Early (immediate) treatment makes a big difference.


35 posted on 12/10/2022 11:09:56 AM PST by Ford4000
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To: upchuck

“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.


36 posted on 12/10/2022 11:33:06 AM PST by AppyPappy (Biden told Al Roker "America is back". Unfortunately, he meant back to the 1970's)
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To: Jane Long

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.


37 posted on 12/10/2022 12:55:07 PM PST by neefer (Bad spellers of the world, untie!)
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To: SeekAndFind

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...


38 posted on 12/10/2022 2:47:32 PM PST by stylin19a (I want to be 18 again and ruin my life differently.  I have new ideas.)
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To: SeekAndFind

Fauci’s lap dogs


39 posted on 12/11/2022 12:20:49 PM PST by Nifster (OI see puppy dogs in the clouds )
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To: allendale

They did this BEFORE Biden


40 posted on 12/11/2022 12:21:29 PM PST by Nifster (OI see puppy dogs in the clouds )
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