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	<title>Ivermectin Clinical Trials - Medika Life</title>
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		<title>Ivermectin is Dead and Buried Despite NIH Website Misstep and Twitter Buzz</title>
		<link>https://medika.life/ivermectin-is-dead-and-buried-despite-nih-website-misstep-and-twitter-buzz/</link>
		
		<dc:creator><![CDATA[Robert Turner, Founding Editor]]></dc:creator>
		<pubDate>Thu, 01 Sep 2022 11:46:17 +0000</pubDate>
				<category><![CDATA[Consumer Safety]]></category>
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					<description><![CDATA[<p>Ivermectin is a global con, sold by unscrupulous doctors and healthcare professionals as a treatment for Covid. It doesn't work.</p>
<p>The post <a href="https://medika.life/ivermectin-is-dead-and-buried-despite-nih-website-misstep-and-twitter-buzz/">Ivermectin is Dead and Buried Despite NIH Website Misstep and Twitter Buzz</a> appeared first on <a href="https://medika.life">Medika Life</a>.</p>
]]></description>
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<p><em><strong>[Editor-in-Chief Note: Ivermectin is now trending on Twitter as a treatment for COVID-19. We republish this report by Medika Life Founding Editor Robert Turner on the dangers to consumers who see ivermectin as a go-to therapy now.</strong></em> <em><strong>&#8220;Ivermectin has been shown to inhibit replication of SARS-CoV-2 in cultures. However, pharmacokinetic/dynamic studies suggest achieving plasma concentrations necessary in vitro require doses 100X higher than approved for humans.&#8221;</strong></em>]</p>



<p id="346a">We attended the digital funeral today of an innocent victim, slaughtered in a horrific drive-by shooting. That victim was of course Ivermectin, a wonder drug that has over the last two decades saved countless lives. The vehicle involved was the pandemic and the vehicle’s occupants, none other than individuals from within the medical and wellness sectors.</p>



<p id="a24c">To understand why people sworn to protect their patients at all costs would cross over to the dark side, we need to highlight facts that have surfaced over the last few months. Understanding motive will I hope also enable those who remain skeptical to accept the truth about Ivermectin.</p>



<blockquote class="wp-block-quote td_pull_quote td_pull_center is-layout-flow wp-block-quote-is-layout-flow"><p><strong>It is not a treatment or prophylactic for Covid-19 or the SARS-CoV2 virus. It never was.</strong></p></blockquote>



<p id="2907">A small,&nbsp;<a href="https://www.principletrial.org/news/ivermectin-to-be-investigated-as-a-possible-treatment-for-covid-19-in-oxford2019s-principle-trial">as yet unvalidated possibility exists</a>&nbsp;that it may offer some benefit to late-stage Covid-19 patients, but that remains inconclusive pending further research.&nbsp;<a href="https://medium.com/beingwell/the-simple-truth-ivermectin-and-hcq-supporters-fail-to-acknowledge-39c08968396f">Proving Ivermectin’s efficacy</a>&nbsp;in early-stage Covid or as prophylactic poses very real, and some would argue, insurmountable methodological challenges.</p>



<p id="9581">All Ivermectin ever claimed to be, was an anti-parasitic drug. It is as much a victim of the intricate web of deceit and deception spun by certain individuals, as the intended targets, who consume it in the mistaken belief it offers salvation.</p>



<p id="598c">Let&#8217;s begin by examining how that web has begun to unravel and then we’ll take a closer look at those who engineered the deception and why.</p>



<h2 class="wp-block-heading" id="b72e">The Preprint</h2>



<p id="cde7">Most of the scientific and medical community speaking up on behalf of Ivermectin used the following pre-print as validation for the efficacy of the drug as a Covid-19 treatment. The paper was called&nbsp;<a href="https://www.researchsquare.com/article/rs-100956/v4?redirect=/article/rs-100956">Efficacy and Safety of Ivermectin for Treatment and prophylaxis of COVID-19 Pandemic</a>&nbsp;and the first of four versions was made available to the public on the 13th of November, 2020.</p>



<p id="3d77">The preprint was published on researchsquare.com and if you click on the link above you will see that the preprint has been removed and an investigation initiated into the content and contributing authors. Why is explained below.</p>



<p id="08d8">ReasearchSquare posts the following text in red font above the preprints it publishes as fair warning that the content is not peer-reviewed and should not be considered as anything more than an unverified opinion.</p>



<blockquote class="wp-block-quote td_quote_box td_box_center is-layout-flow wp-block-quote-is-layout-flow"><p>This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.</p></blockquote>



<p id="e005">Despite this, the preprint was seized upon,&nbsp;<a href="https://scholar.google.es/scholar?q=Efficacy+and+Safety+of+Ivermectin+for+Treatment+and+prophylaxis+of+COVID-19+Pandemic&amp;hl=en&amp;as_sdt=0&amp;as_vis=1&amp;oi=scholart">Google scholar&nbsp;</a>showing 43 citations. In case you&#8217;re not familiar with publication terms, in scientific journals, a citation is a reference from a published article to a published paper (note, not a preprint) intended to provide confirmation or reference for content.</p>



<p id="ac5c">In short, 43 papers that have done exactly what the warning above suggests shouldn&#8217;t be done. Why this warning exists and preprints are broadly unreferenced in the scientific community became apparent as peer review set about validating the integrity of the data in the preprint and claims of plagiarism that had been leveled against the authors.</p>



<h3 class="wp-block-heading" id="24c2"><strong>Examining the Data</strong></h3>



<p id="c2a9">Much like forensic auditors check for cooked books, forensic data analysts exist to sniff out anything fishy in sets of data. Nick Browne was tasked with examining the data used in the preprint to validate claims made relating to the efficacy of Ivermectin as a treatment for Covid-19. You can read&nbsp;<a href="https://steamtraen.blogspot.com/2021/07/Some-problems-with-the-data-from-a-Covid-study.html?m=1">a full breakdown of his analysis here</a>&nbsp;if the summation below is insufficient.</p>



<p id="e1d8">The data file for the research was made available as a locked Excel spreadsheet, rather than an SPSS 21 file, the tool the preprint authors purported they had used for their analysis. Browne was forced to pay for access to the file and then had to manually guess at the password (1234) before gaining access to the Excel data. From there, things rapidly progressed from bad to worse.</p>



<p id="b449">Many of the patients who died appear to be duplicates. According to the original data, there were ‘four’ patients with the initials NME, NEM, and NES (twice), who were all males aged 51 years old, all suffered from diarrhoea(sic), had the same blood hemoglobin levels, were all diagnosed on the 22nd of May, and all died on the 29th of May 2020. They also all share identical values in at least four other data columns.</p>



<p id="b96e">At least a further ten deceased patients also display evidence of being duplicated. Duplicates make up around half of the recorded deaths. Much of the patient data is identical, but minor changes exist, proving that a simple copy and paste error cannot be the cause of the duplicates.</p>



<p id="8441">In no particular order, and again, please refer to the&nbsp;<a href="https://steamtraen.blogspot.com/2021/07/Some-problems-with-the-data-from-a-Covid-study.html?m=1">linked report</a>&nbsp;for specifics, Browne also identified issues with;</p>



<ul><li>Formatting</li><li>Numbers containing non-numeric characters</li><li>Confusion around date formats</li><li>Repeated or cloned sequences of data</li><li>Apparent failures of randomization</li><li>Descriptive statistics that did not match the preprint</li><li>Table results that do not match the preprint</li><li>Other issues included age distribution, trailing digits of numerical variables, study entry and exit dates, and last, but not least, the lack of the SPSS file.</li></ul>



<p id="9934">In summation, Browne arrived at the following conclusion;</p>



<blockquote class="wp-block-quote td_quote_box td_box_center is-layout-flow wp-block-quote-is-layout-flow"><p>In view of the problems described in the preceding sections, most notably the repeated sequences of identical numbers corresponding to apparently “cloned” patients, it is difficult to avoid the conclusion that the Excel file provided by the authors does not faithfully represent the results of the study, and indeed has probably been&nbsp;<strong>extensively manipulated by hand</strong>.</p></blockquote>



<p id="bb01">We aren&#8217;t limited by Browne’s proclivity for professional restraint so we’ll call it as he saw it. The data provided for the preprint are a largely concocted fairy tale, an ambitious con designed to mislead. Manipulation of the data was not accidental but rather intentional, engineered to support very specific predetermined outcomes, for reasons we will examine below.</p>



<h2 class="wp-block-heading" id="448b">Plagiarism</h2>



<p id="8ba9">Lead-authored by Dr. Ahmed Elgazzar, a Professor Emeritus at the University of Behna, the preprint claimed to represent the results of a multi-center, 600-patient study evaluating the use of ivermectin in preventing and treating COVID-19.</p>



<p id="238e">The author&#8217;s claims centered around the following;</p>



<ul><li>Ivermectin significantly reduced both the number of deaths and the length of patient’s hospital stay compared to standard Egyptian treatment protocols</li><li>Ivermectin exhibited a substantial effect in preventing the onset of the disease in the first place, in other words, it acted as a prophylactic against the virus.</li></ul>



<p id="0ce3">The article by Jack Lawrence we will reference with regards to the above can be&nbsp;<a href="https://grftr.news/why-was-a-major-study-on-ivermectin-for-covid-19-just-retracted/">read in full here</a>, and again, we have provided a summation of his findings below. There are numerous instances in the preprint of text being lifted directly from an original source and not credited. In a schoolboy fashion, the authors have tried to obfuscate the plagiarism by changing a few words in each extract.</p>



<h4 class="wp-block-heading" id="e9b6"><strong>Plagiarized Elgazzar et al 2020</strong></h4>



<p id="9fea"><em>“This novel virus infection has incapacitated the world’s medical services framework as well as the political and financial relations [2. As another section in human life opens</em></p>



<p id="35cb"><em>up [3, the world is by all accounts divided into two sections pre-and post-COVID19 time.”</em></p>



<h4 class="wp-block-heading" id="638e"><strong>Original Heidary &amp; Reza Gharebaghi 2020</strong></h4>



<p id="0f18"><em>“This novel virus has paralyzed not only the world’s health care system but also the political and economic relations [13]. As a new chapter in human life opens up [14], the world seems to be divided into two parts pre- and post-COVID19 era.”</em></p>



<p id="10af"><em>Note: Elgazzar even used the same sources</em></p>



<p><a href="https://www.nature.com/articles/s414290200336-z">https://www.nature.com/articles/s414290200336-z</a></p>



<p id="5137">A schoolboy could be chastised and excused for similar behavior, but there can be no excuse offered by the preprint author, Elgazzar, who would be intimately familiar with protocols surrounding scientific publications. The preprint is&nbsp;<a href="https://drive.google.com/file/d/1ZFKX_lPK7neEq0e0Sxe8iG5jkqrU7L1l/view">littered with further examples of plagiarism</a>&nbsp;and Larence uncovered further unethical actions pertaining to the study.</p>



<p id="4ba2">While the disclosures above may shock some, they pale in comparison to what is to follow, namely acknowledging the extent of duplicity and malintent by members of the medical community across the globe. Doctors, scientists, pharmacists, alternate health practitioners, and individuals from the wellness sector have teamed up to exploit vulnerable patients for financial gain in the midst of a pandemic.</p>



<p id="d221">That is the only logical and unavoidable conclusion that can be drawn from the Ivermectin fiasco and avoiding confronting this unpleasant reality prevents us from protecting vulnerable patient populations.</p>



<h2 class="wp-block-heading" id="ff24">Acknowledging the Grift</h2>



<p id="6a65">Medika first became aware of Ivermectin and its ability to kill the SARS-CoV2 virus in a&nbsp;<a href="https://www.nature.com/articles/s41429-020-0336-z">paper in Nature, released in mid-2020</a>. We published an article, highlighting the results, achieved in vitro, and suggested, like others, that immediate trials should be undertaken to see if the effects could be replicated in vivo.</p>



<p id="072c">The pandemic was gaining momentum and there would be no shortage of willing trial candidates. The problems though were obvious at the outset. Ivermectin had successfully killed the test tube sample in a laboratory, but achieving similar dosage levels in human subjects was highly inadvisable and patently unachievable without endangering the patient&#8217;s health.</p>



<p id="c478">Conducting broad-scale trials at tolerable dosages should have been a priority for either the&nbsp;FDA&nbsp;or a recognized European health authority. No one stepped up to conclusively prove or disprove the potential of Ivermectin as a Covid treatment. The lack of credible trials was potentially driven by an industry-wide skepticism of the drug&#8217;s ability to impact viruses (it is an anti-parasitic) and although this rationale made sense to scientific circles, the public was unable to make the connect.</p>



<p id="f22f">A potential&nbsp;<strong>‘treatment void’&nbsp;</strong>had been unintentionally created for Ivermectin and it was into this void, as is so often their want, that the grifters stepped, seizing an opportunity to co-opt the pandemic for profit on a global scale.</p>



<h3 class="wp-block-heading" id="7218"><strong>Plumbing the dark depths of deception</strong></h3>



<p id="c06d">India was one of the countries that fully embraced the grift. Provincial authorities distributed Ivermectin as a Covid treatment to residents and other countries, notably South American populations, followed suit.</p>



<p id="9b81">Proving the efficacy of a treatment is often far simpler than disproving its efficacy and the grifters took full advantage, distributing their ‘Covid treatment’ via the global digital conspiracy network surrounding the pandemic. They assured the public that the drug was being intentionally withheld and the rest is history. Across the internet, both the public and many from within the medical community bought into the Ivermectin lie.</p>



<p id="6d98">A lie that was cemented in many minds as fact by anecdotal evidence, falsified data and manipulated trials like the one conducted by Elgazzar and his colleagues. It is far easier to believe a convenient lie than face an unpleasant truth.</p>



<p id="9aa8">Doctors (the term is used loosely) have taken advantage of a vulnerable patient population to sell them drugs and in case you think this deplorable behavior was limited to non-western countries, the evidence suggests the west drove the trend. This is not simply supposition but fact.</p>



<p id="abe8">In the US, rapidly formed organizations like&nbsp;<a href="https://medika.life/americas-frontline-doctors-face-long-overdue-medical-and-legal-censure/">America’s Frontline Doctors</a>, a despicable congruence of dishonest doctors, pharmacists, and marketing individuals set about creating the ultimate pill mill for not only Ivermectin but the other darling of Covid conspiracies, hydroxychloroquine.&nbsp;<a href="https://medika.life/exposing-americas-frontline-doctors-and-their-financial-empire-built-on-hydroxychloroquine/">You can read more on that here</a>, including comments from exploited patients, shown below the article.</p>



<p id="6f36">This pattern of profiting by deception from the sale of Ivermectin and other Covid cures continues unabated. We have unintentionally created the environment where large sums of money can be made from misleading the public in the midst of a pandemic. The fact the public&#8217;s health may be forfeit is irrelevant to the quacks and charlatans claiming to be healers. </p>



<p id="3f5d">These individuals are doctors, nurses, pharmacists, caregivers, and individuals of science. The lie could not exist without their duplicity and in many instances, the lie exists at their instigation. It is a hard truth to face and one we look away from. We need to openly acknowledge this and develop effective methods to prevent future occurrences.</p>



<p id="d1ed">Ivermectin’s lasting legacy should not be as the drug that failed to treat Covid and fooled the world. It should be seen as the drug that taught the world about a bitter pill, one we need to swallow now,&nbsp;<a href="https://medika.life/povodine-iodine-covid/">lest we repeat history</a>.</p>
<p>The post <a href="https://medika.life/ivermectin-is-dead-and-buried-despite-nih-website-misstep-and-twitter-buzz/">Ivermectin is Dead and Buried Despite NIH Website Misstep and Twitter Buzz</a> appeared first on <a href="https://medika.life">Medika Life</a>.</p>
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		<post-id xmlns="com-wordpress:feed-additions:1">12984</post-id>	</item>
		<item>
		<title>Ivermectin is NOT Hydroxychloroquine. Why is the FDA Ignoring a Potential Covid Treatment?</title>
		<link>https://medika.life/ivermectin-is-not-hydroxychloroquine-why-is-the-fda-ignoring-a-potential-covid-treatment/</link>
		
		<dc:creator><![CDATA[Robert Turner, Founding Editor]]></dc:creator>
		<pubDate>Sun, 10 Jan 2021 05:32:33 +0000</pubDate>
				<category><![CDATA[Coronavirus]]></category>
		<category><![CDATA[Editors Choice]]></category>
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		<category><![CDATA[Health News and Views]]></category>
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		<category><![CDATA[Trending in Pharma]]></category>
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					<description><![CDATA[<p>Ivermectin has shown promise as a potential treatment. It needs to  be urgently evaluated under the guidance of the FDA</p>
<p>The post <a href="https://medika.life/ivermectin-is-not-hydroxychloroquine-why-is-the-fda-ignoring-a-potential-covid-treatment/">Ivermectin is NOT Hydroxychloroquine. Why is the FDA Ignoring a Potential Covid Treatment?</a> appeared first on <a href="https://medika.life">Medika Life</a>.</p>
]]></description>
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<p>In <a href="https://medium.com/beingwell/is-ivermectin-the-covid19-miracle-weve-been-looking-for-d75bb310a0ac" target="_blank" rel="noreferrer noopener">June of 2020, Australian researchers published a study </a>that showed ivermectin inhibited the replication of SARS-CoV-2 in a laboratory setting. The results were in vitro, which is not the same as testing the drug on humans or animals. The FDA responded by releasing a letter out of concern warning consumers not to self-medicate with ivermectin products intended for animals.</p>



<p>Six months have passed since then, thousands of Americans have died and this article is a direct call on the FDA for an explanation. Why was ivermectin not immediately placed into sanctioned human trials? It is approved for use in humans by the FDA, and the in vitro results should have pointed to a possible candidate to treat Covid. Clearly, six months later, nothing has been done and this raises very worrying questions,</p>



<p>If a candidate like ivermectin has been ignored, what other drugs has the FDA blindsided? Why is there no official NIH or FDA body to examine the efficacy of existing drugs and fairly evaluate any that show potential to combat covid? Could this simply be another of the many administrative oversights or is there something more sinister lurking behind it? Read on, as we examine the ivermectin issue.</p>



<h2 class="wp-block-heading">An introduction</h2>



<p>I am thrilled we have the covid vaccines being released into the public as I write this. It&#8217;s a technical miracle and evidence of what a community can achieve with a common goal, the proper motivation, and the removal of restrictive red tape, which, under normal circumstances, is required to safeguard us. The vaccines are however going to take months before their effects become evident in the general population.&nbsp;</p>



<p>While <a href="https://www.nytimes.com/2021/01/09/health/eligible-for-covid-vaccine.html" rel="noreferrer noopener" target="_blank">individual states dick about with their vaccination strategies</a>, sell vaccines to<a href="https://www.washingtonpost.com/health/2021/01/05/florida-nursing-home-covid-vaccine/" rel="noreferrer noopener" target="_blank"> wealthy donors and country club members</a>, and try their best to get all the healthcare workers vaccinated, despite <a href="https://www.forbes.com/sites/jemimamcevoy/2021/01/04/pharmacist-destroyed-coronavirus-vaccine-doses-out-of-belief-they-were-unsafe-prosecutor-says/" rel="noreferrer noopener" target="_blank">some trying to sabotage the process</a>, people are still contracting Covid at record numbers in the US. Hospitals are nearing, or at capacity in many states, and Americans are dying in record numbers from Covid-19. On the 7th of January, more than 4000 Americans died in a single day.</p>



<p>That shouldn&#8217;t be acceptable in anyone’s eyes and<strong> every action we can possibly take to prevent these deaths needs to be explored</strong>. Explored thoroughly, so that it can either be discounted or implemented and we don&#8217;t have time to waste, people are dying. Trials need to be rapidly implemented with the active approval and involvement of the FDA.&nbsp;</p>



<blockquote class="wp-block-quote td_pull_quote td_pull_center is-layout-flow wp-block-quote-is-layout-flow"><p>It&#8217;s not as though we don&#8217;t have a queue of willing trial subjects. People are literally dying to try anything that suggests even a hint of efficacy.</p></blockquote>



<p>Months ago (April) I wrote an article on Ivermectin and the success the drug had shown in-vitro against the coronavirus. I was excited when I came across the study as I have had personal experience with this drug and its efficacy against Nile River Blindness in the human population. It works spectacularly well, so much so that it won the Nobel Prize. It is not hydroxychloroquine.</p>



<p>In fact, in the world of drugs, Ivermectin is something of a fairy tale story, literally picked up out of the soil by a Japanese scientist and carried to glory on the first philanthropic donation of drugs in the world by Merck.&nbsp;</p>



<p>We know a great deal about Ivermectin&#8217;s safety in human use. Its application is in the destruction of nasty parasitic visitors and reactions to the drug are for the most part associated with the parasites attacking their hosts on the way out, rather than the drug affecting the host. Arguably, without parasites present, the risk of adverse reactions to Ivermectin would <a href="https://www.who.int/bulletin/volumes/82/8/editorial30804html/en/" target="_blank" rel="noreferrer noopener">decrease significantly</a>.</p>



<p>So back to my opening question. Why hasn&#8217;t the FDA and NIH trialed this drug in hospitals across the US, six months after in vitro trials suggested it as a possible candidate? To be clear, if Ivermectin can save one life in fifty, then it’s a worthy treatment. If it does more and is proven to show prophylactic properties, then that is a huge win. </p>



<p>Every additional benefit is a win, but the point is this. <strong>Until we actually try it, WE DO NOT KNOW!</strong> And in case I didn&#8217;t stress this sufficiently, people are dying daily, by the thousands.</p>



<p>I was sent a link this morning to a video posted by a Republican senator, Ron Johnson, chair of a Senate committee entitled ‘Early Outpatient Treatment: An Essential Part of a COVID-19 Solution’. I’ve included it below and before we get to it, I’ve done a little homework on your behalf regarding referenced materials in the video and the doctor presenting it, Pierre Kory, and his organization, the AFCCC. Here are the facts as they now stand, note, <strong>not my interpretation, but actual facts.</strong></p>



<h3 class="wp-block-heading">Who is Dr. Pierre&nbsp;Kory?</h3>



<p>Dr. Pierre Kory is an Associate Professor of Medicine at St. Luke’s Aurora Medical Center in Milwaukee. He testified on December 8, 2020, at the U.S. Senate Committee on Homeland Security and Governmental Affairs. You can view the Committee’s entire hearing by following <a href="https://www.hsgac.senate.gov/early-ou..." rel="noreferrer noopener" target="_blank">this link</a> or you can <a href="http://www.hsgac.senate.gov/download/kory12-08-2020" rel="noreferrer noopener" target="_blank">download a transcript of Dr. Kory’s testimony here</a>.</p>



<p>Kory is a founding member of <a href="https://covid19criticalcare.com/" rel="noreferrer noopener" target="_blank">FLCCC</a> or in long-form, Front Line COVID-19 Critical Care Alliance. Their stated goal on their website is this. ”Prophylaxis &amp; Treatment Protocols for COVID-19&#8243;. Let&#8217;s first deal with this entity and its members.&nbsp;</p>



<p>FLCCC push their<a href="https://covid19criticalcare.com/math-hospital-treatment/" rel="noreferrer noopener" target="_blank"> treatment protocols for early intervention</a> in covid patients requiring supplemental oxygen. This article isn&#8217;t about the FLCCC’s credibility or agendas, which may or may not be above reproach. Nor does it speak to Dr. Kory’s credentials. This is about Ivermectin and its potential as a covid treatment.&nbsp;</p>



<p>Clearly, as can be seen from the FLCCC site, Ivermectin is one of the treatments they recommend. They claim to base this on their actual experience and various trials, some of which we will examine below,</p>



<p>Let&#8217;s get to the Kory video, here it is, and you can watch it now or later.</p>



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<iframe title="Dr. Pierre Kory Senate Testimony On Early COVID-19 Treatments" width="696" height="392" src="https://www.youtube.com/embed/YgOAaLmoa68?feature=oembed" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture" allowfullscreen></iframe>
</div></figure>



<p>The response to Kory’s claims around Ivermectin has been as follows from the medical community, the FDA, and NIH. Firstly, from infectious disease expert at John Hopkins University, Dr. Amesh Adalja. who said most of the research around ivermectin at the moment is made up of anecdotes and studies that are not the gold standard in terms of how to use ivermectin.</p>



<blockquote class="wp-block-quote td_pull_quote td_pull_center is-layout-flow wp-block-quote-is-layout-flow"><p>“We need to get much more data before we can say this is a definitive treatment,” he said. “We would like to see more data before I recommend it to my patients.”</p></blockquote>



<p><a href="https://www.fda.gov/animal-veterinary/product-safety-information/faq-covid-19-and-ivermectin-intended-animals" rel="noreferrer noopener" target="_blank">The U.S. Food and Drug Administration</a> and the <a href="https://www.covid19treatmentguidelines.nih.gov/antiviral-therapy/ivermectin/" rel="noreferrer noopener" target="_blank">National Institutes of Health</a> have said that the drug is not approved for the prevention or treatment of COVID-19. According to the FDA, side effects of the drug include skin rash, nausea, and vomiting. So just exactly what is Ivermectin approved for in the US?&nbsp;</p>



<p>It does have FDA approval. Ivermectin is approved in the U.S. for human consumption in tablet form to treat parasitic worms as well as a topical solution to treat external parasites. The drug is also available for animals, but that&#8217;s neither here nor there. Many of the same drugs and antibiotics are used in both human and animal populations.&nbsp;</p>



<h3 class="wp-block-heading">Documented and Published Studies</h3>



<p>You can find links below to various studies that claim to prove the efficacy of Ivermectin against Covid-19. It should be noted that the trials listed below are riddled with flaws and inconsistencies. None, in our opinion, offer conclusive evidence to the efficacy of ivermectin as a treatment or prophylaxis for the coronavirus. They do however hint at a potential that cannot be ignored, particularly given skyrocketing deaths.</p>



<p><strong>November 16, 2020 | Egypt</strong>: <a target="_blank" href="https://doi.org/10.21203/rs.3.rs-100956/v2" rel="noreferrer noopener sponsored nofollow">Efficacy and safety of ivermectin for treatment and prophylaxis of COVID-19 pandemic</a> &#8211; Elgazzar A, Basma H, Shaimaa Abo Y, Basma H, Mohy H, Hany M (Research Square; 100956) <a target="_blank" href="https://doi.org/10.21203/rs.3.rs-100956/v2" rel="noreferrer noopener">https://doi.org/10.21203/rs.3.rs-100956/v2</a></p>



<p><strong>November 3, 2020 | India:</strong> <a target="_blank" href="https://doi.org/10.1101/2020.10.29.20222661" rel="noreferrer noopener">Role of Ivermectin in the prevention of COVID-19 infection among health care workers in India</a> &#8211; A matched case-control study; Behera P, Patro BK, Singh AK, et al. (medRxiv)<a target="_blank" href="https://doi.org/10.1101/2020.10.29.20222661" rel="noreferrer noopener">https://doi.org/10.1101/2020.10.29.20222661</a></p>



<p><strong>October 27, 2020 | Iraq</strong>: <a target="_blank" href="https://doi.org/10.1101/2020.10.26.20219345" rel="noreferrer noopener">Controlled randomized clinical trial on using ivermectin with doxycycline for treating COVID-19 patients in Baghdad, Iraq</a> &#8211; Hashim HA, Maulood MF, Rasheed AM, Fatak DF, Kabah KK, Abdulamir AS (medRxiv) <a target="_blank" href="https://doi.org/10.1101/2020.10.26.20219345" rel="noreferrer noopener">https://doi.org/10.1101/2020.10.26.20219345</a></p>



<p><strong>October 22 | Peru:</strong> <a target="_blank" href="https://dx.doi.org/10.1016%2Fj.arbr.2020.06.006" rel="noreferrer noopener">Antiviral and anti-inflammatory properties of ivermectin and its potential use in COVID-19</a> &#8211; Portmann-Baracco A, Bryce-Alberti M, Accinelli RA (NCBI/Arch Bronconeumol/ScienceDirect) <a target="_blank" href="https://dx.doi.org/10.1016%2Fj.arbr.2020.06.006" rel="noreferrer noopener">https://dx.doi.org/10.1016%2Fj.arbr.2020.06.006</a></p>



<p><strong>October 12, 2020 | USA:</strong> <a target="_blank" href="https://doi.org/10.1016/j.chest.2020.10.009" rel="noreferrer noopener">Use of ivermectin is associated with lower mortality in hospitalized patients with COVID-19</a> &#8211; Rajter J-C, Sherman MS, Fatteh N, Vogel F, Sacks J, Rajter J-J (ICON study; Chest) <a target="_blank" href="https://doi.org/10.1016/j.chest.2020.10.009" rel="noreferrer noopener">https://doi.org/10.1016/j.chest.2020.10.009</a></p>



<p><strong>October 2020 | Peru:</strong> <a target="_blank" href="https://www.researchgate.net/publication/344469305_Real-World_Evidence_The_Case_of_Peru_Causality_between_Ivermectin_and_COVID-19_Infection_Fatality_Rate" rel="noreferrer noopener">Real-world evidence: The case of Peru. Causality between ivermectin and COVID-19 infection fatality rate</a> &#8211; Juan Chamie (ResearchGate) <a target="_blank" href="https://www.researchgate.net/publication/344469305_Real-World_Evidence_The_Case_of_Peru_Causality_between_Ivermectin_and_COVID-19_Infection_Fatality_Rate" rel="noreferrer noopener">https://www.researchgate.net/publication/344469305_Real-World_Evidence_The_Case_of_Peru_Causality_between_Ivermectin_and_COVID-19_Infection_Fatality_Rate</a></p>



<p><strong>August 24, 2020 | Bangladesh:</strong> <a target="_blank" href="https://clinicaltrials.gov/ct2/show/NCT04523831" rel="noreferrer noopener">Clinical trial of ivermectin plus doxycycline for the treatment of COVID-19 infection</a> &#8211; Dr. Reaz Mahmud, Dhaka Medical College (ClinicalTrials.gov; NCT04523831) <a target="_blank" href="https://clinicaltrials.gov/ct2/show/NCT04523831" rel="noreferrer noopener">https://clinicaltrials.gov/ct2/show/NCT04523831</a></p>



<p><strong>June 11, 2020 | Argentina</strong>: <a target="_blank" href="https://clinicaltrials.gov/ct2/show/NCT04425850" rel="noreferrer noopener">Usefulness of topical ivermectin and carrageenan to prevent contagion of COVID-19 (IVERCAR)</a> &#8211; Hector E Carvallo, Eurnekian Public Hospital (ClinicalTrials.gov; NCT04425850) <a target="_blank" href="https://clinicaltrials.gov/ct2/show/NCT04425850" rel="noreferrer noopener">https://clinicaltrials.gov/ct2/show/NCT04425850</a></p>



<p><strong>June 9, 2020 | Egypt:</strong> <a target="_blank" href="https://clinicaltrials.gov/ct2/show/NCT04422561" rel="noreferrer noopener">Prophylactic Ivermectin in COVID-19 Contacts</a> &#8211; Waheed Shouman, Zagazig University (ClinicalTrials.gov; NCT04422561) <a target="_blank" href="https://clinicaltrials.gov/ct2/show/NCT04422561" rel="noreferrer noopener">https://clinicaltrials.gov/ct2/show/NCT04422561</a></p>



<p><strong>June 2020 | Australia:</strong> <a target="_blank" href="https://doi.org/10.1016/j.antiviral.2020.104787" rel="noreferrer noopener">The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro</a> &#8211; Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM (Antiviral Res.; 178:104787) <a target="_blank" href="https://doi.org/10.1016/j.antiviral.2020.104787" rel="noreferrer noopener">https://doi.org/10.1016/j.antiviral.2020.104787</a></p>



<p>A very balanced and well-structured analysis of these studies can be found on Rebel EM and we recommend you read it. Their clinical takeaways from the available evidence on ivermectin are as follows. (Bold text highlighted by Medika).</p>



<ul><li>Evidence for the use of Ivermectin is based on in vitro, prophylaxis, clinical, safety, and large-scale epidemiologic studies (heterogenous populations in multiple different settings) BUT…</li><li>Many of the trials thus far are methodologically flawed without enough information about baseline demographics, multiple primary outcomes, soft/subjective outcomes, convenience samples, and unclear definitions, just to name a few</li><li>Additionally, a valid concern in evaluating the literature is that many of the trials have not yet passed the peer review process and are in pre-print format</li><li>Although Ivermectin is cheap, readily available, with a fairly safe side effect profile, based on the evaluation of the literature above, at this time, Ivermectin should not be recommended outside of a clinical trial to ensure we get a true answer of effect</li><li><strong>Ivermectin is interesting, there is certainly signal to evaluate further</strong>, but in our desire to want a treatment option, let’s not continue to do the same thing over and over again, as we saw play out with Hydroxychloroquine</li></ul>



<p>It is perhaps worth mentioning in closing. All across America, many frontline doctors and medical staff are currently using ivermectin as a prophylactic. Is it working? Well, again, we don’t know as it isn&#8217;t being studied properly in the U.S.&nbsp;</p>



<p>The point is that this option if it does in fact prove efficacious against coronavirus, should be rolled out to the public. No one else is to blame here for the complete lack of action, other than the FDA and NIH and their hesitancy to encourage proper trials. The ball is firmly in their court.</p>



<h3 class="wp-block-heading">An interesting footnote (Jan 11,2021)</h3>



<p>India has extensive experience with both ivermectin and hydroxychloroquine in the treatment of covid. This <a href="https://trialsitenews.com/an-unlikely-nation-is-kicking-this-pandemic-guess-which-then-why/" target="_blank" rel="noreferrer noopener">mostly anecdotal report from Trialsitenews.com</a> makes for fascinating reading and if anything, highlights the US&#8217;s lack of interest in pursuing any course, other than vaccines, in combating covid.</p>
<p>The post <a href="https://medika.life/ivermectin-is-not-hydroxychloroquine-why-is-the-fda-ignoring-a-potential-covid-treatment/">Ivermectin is NOT Hydroxychloroquine. Why is the FDA Ignoring a Potential Covid Treatment?</a> appeared first on <a href="https://medika.life">Medika Life</a>.</p>
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