{"product_id":"ivermectin-and-covid-19-why-some-doctors-say-the-fda-is-ignoring-the-evidence","title":"Ivermectin and COVID-19: Why Some Doctors Say the FDA Is Ignoring the Evidence","description":"\u003cp\u003eThis article translates a Wall Street Journal opinion commentary that questioned why the FDA issued strong warnings against ivermectin as a COVID-19 treatment. The original authors argue that ivermectin is a safe, FDA-approved antiparasitic drug with significant evidence supporting its use against COVID-19, and they cite multiple studies showing reduced pneumonia, oxygen need, hospital stays, and deaths. However, this is an opinion piece, not a peer-reviewed scientific study, and the FDA has not approved ivermectin for COVID-19. This patient-friendly version preserves all data, statistics, and claims from the original article while explaining the medical terms in plain language.\u003c\/p\u003e\n\n\u003ch1\u003eIvermectin and COVID-19: Why Some Doctors Say the FDA Is Ignoring the Evidence\u003c\/h1\u003e\n\n\u003ch2\u003eTable of Contents\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003e\u003ca href=\"#ddn-key-points\"\u003eKey Points\u003c\/a\u003e\u003c\/li\u003e\n\n  \u003cli\u003e\u003ca href=\"#background\"\u003eBackground: A Heated Dispute Over an Old Drug\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#what-is-ivermectin\"\u003eWhat Is Ivermectin? A Proven Medicine With a Nobel Prize Pedigree\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#evidence-treatment\"\u003eEvidence for Treating COVID-19: Numbers From Clinical Trials\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#evidence-prevention\"\u003eEvidence for Preventing COVID-19: Protecting Families and Healthcare Workers\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#safety-record\"\u003eSafety Record: Four Billion Doses and Only 28 Serious Events\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#fdas-position\"\u003eThe FDA's Position: Warnings vs. Mask Recommendations\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#limitations\"\u003eLimitations: What This Opinion Piece Can and Cannot Prove\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#clinical-implications\"\u003eClinical Implications: What This Means for Patients\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#recommendations\"\u003eRecommendations: What Should You Do?\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#ddn-faq\"\u003eFrequently Asked Questions\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#source\"\u003eSource Information\u003c\/a\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003c!-- ddn:keypoints:start --\u003e\n\u003ch2 id=\"ddn-key-points\"\u003eKey Points\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003eThe article is an opinion piece, not a peer-reviewed scientific study.\u003c\/li\u003e\n\u003cli\u003eIn one 115-patient study, ivermectin reduced deaths from 24.5% to 13.3%.\u003c\/li\u003e\n\u003cli\u003eA prevention study showed 8% infection in treated family members vs. 58.4% untreated.\u003c\/li\u003e\n\u003cli\u003eFour billion ivermectin doses have had only 28 serious adverse events reported.\u003c\/li\u003e\n\u003cli\u003eThe FDA has not approved ivermectin for COVID-19 and warns against its use.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c!-- ddn:keypoints:end --\u003e\n\n\n\u003ch2 id=\"background\"\u003eBackground: A Heated Dispute Over an Old Drug\u003c\/h2\u003e\n\u003cp\u003eThe Food and Drug Administration (FDA) claims to follow science. But according to a Wall Street Journal opinion article published July 28, 2021, the agency is attacking a medication it certified as safe back in 1996. That medication is ivermectin, commonly used to treat parasitic infections.\u003c\/p\u003e\n\u003cp\u003eEarlier in 2021, the FDA issued an unusual public warning stating that consumers \"should not use ivermectin to treat or prevent COVID-19.\" The agency's statement included alarming language such as \"serious harm,\" \"hospitalized,\" \"dangerous,\" \"very dangerous,\" \"seizures,\" \"coma and even death,\" and \"highly toxic.\" To anyone reading, it sounded like the FDA was describing poison pills.\u003c\/p\u003e\n\u003cp\u003eBut in fact, ivermectin is an FDA-approved drug with a long history of safe use as an antiparasitic. This article examines why some doctors and researchers believe the FDA's stance is not supported by the evidence, and what patients should know about the controversy.\u003c\/p\u003e\n\n\u003ch2 id=\"what-is-ivermectin\"\u003eWhat Is Ivermectin? A Proven Medicine With a Nobel Prize Pedigree\u003c\/h2\u003e\n\u003cp\u003eIvermectin was developed and marketed by the pharmaceutical company Merck \u0026amp; Co. One of the original article's co-authors, Charles L. Hooper, worked at Merck during the drug's development years.\u003c\/p\u003e\n\u003cp\u003eThe science behind ivermectin earned its developers the \u003cstrong\u003e2015 Nobel Prize in Physiology or Medicine\u003c\/strong\u003e. William C. Campbell and Satoshi Omura won the award for discovering and developing avermectin, which Campbell and his associates then modified to create ivermectin. The Nobel committee recognized that ivermectin \"radically reduced the incidence of river blindness and lymphatic filariasis\" worldwide.\u003c\/p\u003e\n\u003cp\u003eIvermectin appears on the \u003cstrong\u003eWorld Health Organization's List of Essential Medicines\u003c\/strong\u003e—a catalog of the safest and most effective medicines needed in a health system. Merck has donated \u003cstrong\u003efour billion doses\u003c\/strong\u003e of ivermectin to prevent river blindness and other parasitic diseases in Africa and other regions where parasites are common.\u003c\/p\u003e\n\u003cp\u003eA group of ten doctors calling themselves the \u003cstrong\u003eFront Line Covid-19 Critical Care Alliance (FLCCC)\u003c\/strong\u003e have publicly stated that ivermectin is \"one of the safest, low-cost, and widely available drugs in the history of medicine.\"\u003c\/p\u003e\n\n\u003ch2 id=\"evidence-treatment\"\u003eEvidence for Treating COVID-19: Numbers From Clinical Trials\u003c\/h2\u003e\n\u003cp\u003eAccording to the original article, ivermectin fights \u003cstrong\u003e21 viruses\u003c\/strong\u003e, including SARS-CoV-2, the virus that causes COVID-19. Laboratory research published in June 2020 in the journal \u003cem\u003eAntiviral Research\u003c\/em\u003e showed that a single dose reduced the viral load (the amount of virus in cells) by \u003cstrong\u003e99.8% in 24 hours\u003c\/strong\u003e and by \u003cstrong\u003e99.98% in 48 hours\u003c\/strong\u003e.\u003c\/p\u003e\n\u003cp\u003eThe authors state that \u003cstrong\u003e70 clinical trials\u003c\/strong\u003e were evaluating ivermectin for treating COVID-19 at the time of writing. They claim that the statistically significant evidence suggests the drug is safe and works for both treating and preventing the disease.\u003c\/p\u003e\n\u003cp\u003eHere are the key numbers from one study involving \u003cstrong\u003e115 patients with COVID-19\u003c\/strong\u003e who received a single dose of ivermectin:\u003c\/p\u003e\n\u003cul\u003e\n  \u003cli\u003e\n\u003cstrong\u003ePneumonia or cardiovascular complications:\u003c\/strong\u003e 0% in the ivermectin group vs. 11.4% in the control (untreated) group.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eRespiratory distress:\u003c\/strong\u003e 2.6% vs. 15.8%.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eNeed for oxygen:\u003c\/strong\u003e 9.6% vs. 45.9%.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eNeed for antibiotics:\u003c\/strong\u003e 15.7% vs. 60.2%.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eIntensive care admission:\u003c\/strong\u003e 0.1% vs. 8.3%.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eTime to test negative:\u003c\/strong\u003e 4 days vs. 15 days.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eAverage hospital stay:\u003c\/strong\u003e 9 days vs. 15 days.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eMortality (death rate):\u003c\/strong\u003e 13.3% vs. 24.5%.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eThese numbers represent striking differences. To put them in plain language: in this study, ivermectin-treated patients were far less likely to develop serious respiratory complications, required less oxygen and antibiotics, recovered faster, left the hospital earlier, and were nearly half as likely to die.\u003c\/p\u003e\n\n\u003ch2 id=\"evidence-prevention\"\u003eEvidence for Preventing COVID-19: Protecting Families and Healthcare Workers\u003c\/h2\u003e\n\u003cp\u003eThe original article also cites evidence that ivermectin can help \u003cem\u003eprevent\u003c\/em\u003e COVID-19 infection, not just treat it. One 2020 study published in \u003cem\u003eBiochemical and Biophysical Research Communications\u003c\/em\u003e examined what happened when ivermectin was given to family members of confirmed COVID-19 patients.\u003c\/p\u003e\n\u003cp\u003eThe results were dramatic:\u003c\/p\u003e\n\u003cul\u003e\n  \u003cli\u003eLess than \u003cstrong\u003e8%\u003c\/strong\u003e of treated family members became infected.\u003c\/li\u003e\n  \u003cli\u003eBy contrast, \u003cstrong\u003e58.4%\u003c\/strong\u003e of untreated family members became infected.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eAnother study looked at \u003cstrong\u003e200 healthcare workers and others at high risk of exposure\u003c\/strong\u003e. Among those given ivermectin, only \u003cstrong\u003e2%\u003c\/strong\u003e developed COVID-19. Among those in the control group, \u003cstrong\u003e10%\u003c\/strong\u003e developed the disease. That means ivermectin appeared to reduce the infection rate by five-fold in this high-risk group.\u003c\/p\u003e\n\u003cp\u003eThese findings suggest that, if confirmed by larger trials, ivermectin could serve as a valuable preventive tool—especially for people who cannot get a vaccine or who live or work in high-exposure settings.\u003c\/p\u003e\n\n\u003ch2 id=\"safety-record\"\u003eSafety Record: Four Billion Doses and Only 28 Serious Events\u003c\/h2\u003e\n\u003cp\u003eDespite the FDA's alarming language, the original article points out that ivermectin is extremely safe when taken at approved doses. The evidence comes from decades of real-world use:\u003c\/p\u003e\n\u003cul\u003e\n  \u003cli\u003eSince 1998, an estimated \u003cstrong\u003efour billion doses\u003c\/strong\u003e of ivermectin have been administered worldwide.\u003c\/li\u003e\n  \u003cli\u003eThere have been only \u003cstrong\u003e28 cases of serious neurological adverse events\u003c\/strong\u003e reported, according to an article published in 2021 in the \u003cem\u003eAmerican Journal of Therapeutics\u003c\/em\u003e.\u003c\/li\u003e\n  \u003cli\u003eThe same study found that ivermectin has been used safely in \u003cstrong\u003epregnant women, children, and infants\u003c\/strong\u003e.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eTo put that in perspective: four billion doses with only 28 serious events means a serious adverse event rate of less than 0.0000007%. Most over-the-counter medications do not have safety records anywhere near that favorable.\u003c\/p\u003e\n\u003cp\u003eThe original authors argue that if the FDA were truly driven by science and evidence, it would issue an emergency-use authorization (EUA) for ivermectin for COVID-19. Instead, the FDA asserts without presenting evidence that ivermectin is dangerous.\u003c\/p\u003e\n\n\u003ch2 id=\"fdas-position\"\u003eThe FDA's Position: Warnings vs. Mask Recommendations\u003c\/h2\u003e\n\u003cp\u003eAt the bottom of the FDA's warning against ivermectin is a familiar statement: \"Meanwhile, effective ways to limit the spread of COVID-19 continue to be to wear your mask, stay at least 6 feet from others who don't live with you, wash hands frequently, and avoid crowds.\"\u003c\/p\u003e\n\u003cp\u003eThe original authors ask a pointed question: Is this mask and distancing advice based on the same kind of double-blind, placebo-controlled studies that the FDA requires for drug approvals? They say no. They point out that the FDA has not applied the same standard of evidence to its public health recommendations that it demands from pharmaceutical companies.\u003c\/p\u003e\n\u003cp\u003eThis contrast—warn aggressively against a drug with a strong safety record, while issuing public health directives without controlled trial evidence—is the core of the authors' frustration.\u003c\/p\u003e\n\n\u003ch2 id=\"limitations\"\u003eLimitations: What This Opinion Piece Can and Cannot Prove\u003c\/h2\u003e\n\u003cp\u003eIt is essential to note that this article is an \u003cstrong\u003eopinion commentary\u003c\/strong\u003e, not a peer-reviewed scientific study. The authors are expressing their views based on published research, but they do not provide full methodological details of every study they cite. Some of the studies cited (like the 115-patient trial) may have been observational, meaning they did not randomly assign patients to treatment and control groups the way a gold-standard double-blind trial would.\u003c\/p\u003e\n\u003cp\u003eAdditionally, one of the authors (Charles L. Hooper) previously worked at Merck, the company that developed ivermectin. This could be a potential conflict of interest, though he is writing as a co-author with an economist from Stanford's Hoover Institution.\u003c\/p\u003e\n\u003cp\u003eThe original article also does not discuss any negative studies of ivermectin, and it simplifies a complex and rapidly changing evidence landscape. Well-known medical organizations, including the National Institutes of Health and the World Health Organization, have reviewed the evidence differently and recommend against routinely using ivermectin for COVID-19 outside of clinical trials.\u003c\/p\u003e\n\n\u003ch2 id=\"clinical-implications\"\u003eClinical Implications: What This Means for Patients\u003c\/h2\u003e\n\u003cp\u003eIf the evidence presented in the original article is accurate, patients with COVID-19 could potentially benefit from ivermectin in several meaningful ways:\u003c\/p\u003e\n\u003cul\u003e\n  \u003cli\u003eLower risk of pneumonia and cardiovascular complications.\u003c\/li\u003e\n  \u003cli\u003eReduced need for oxygen and antibiotics.\u003c\/li\u003e\n  \u003cli\u003eFewer intensive care admissions.\u003c\/li\u003e\n  \u003cli\u003eShorter hospital stays (9 days vs. 15 days).\u003c\/li\u003e\n  \u003cli\u003eLower risk of death (13.3% vs. 24.5%).\u003c\/li\u003e\n  \u003cli\u003ePossible protection for family members and healthcare workers.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eHowever, as of the date of the original article, the FDA had not approved ivermectin for COVID-19 and explicitly warned against its use. This places patients in a difficult position: a drug that many doctors believe is effective and extremely safe, but which federal regulators publicly discourage.\u003c\/p\u003e\n\u003cp\u003eIt is important to understand that \u003cstrong\u003eself-medicating with ivermectin—especially with veterinary formulations—can be dangerous\u003c\/strong\u003e. The FDA's warning was partly in response to reports of people taking animal-grade ivermectin, which can contain ingredients unsafe for humans. The original authors are not advising people to take veterinary drugs; they are arguing that the human-approved form of ivermectin should receive emergency-use authorization.\u003c\/p\u003e\n\n\u003ch2 id=\"recommendations\"\u003eRecommendations: What Should You Do?\u003c\/h2\u003e\n\u003cp\u003eThe original article does not provide specific patient instructions, but its conclusions suggest the following reasonable steps for anyone considering ivermectin for COVID-19:\u003c\/p\u003e\n\u003col\u003e\n  \u003cli\u003e\n\u003cstrong\u003eTalk to your doctor.\u003c\/strong\u003e Do not self-prescribe. Ask your physician whether ivermectin might be appropriate for your situation, especially if you are in an early stage of illness or at high risk of exposure.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eOnly use human-approved ivermectin.\u003c\/strong\u003e Never take products intended for animals. The dose and formulation matter enormously.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eConsider the evidence for prevention.\u003c\/strong\u003e If you live with a confirmed COVID-19 patient or work in a high-risk setting, the studies described above suggest ivermectin could help reduce your risk of infection. Discuss this with a specialist.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eDo not abandon proven measures.\u003c\/strong\u003e Masking, distancing, handwashing, and—most importantly—vaccination remain the mainstream recommendations. The original article questions the evidence behind some of these measures, but it does not definitively prove they are ineffective.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eStay informed.\u003c\/strong\u003e The debate over ivermectin evolved rapidly. Look for updated guidance from major health organizations, and ask your doctor about the latest trial results.\u003c\/li\u003e\n\u003c\/ol\u003e\n\u003cp\u003eThe authors of the original article end with a call to action: if the FDA were truly following the science, it would authorize ivermectin for emergency use in COVID-19. Whether or not you agree, understanding both sides of the argument—and having all the numbers—will help you and your doctor make a better-informed decision.\u003c\/p\u003e\n\n\u003c!-- ddn:faq:start --\u003e\n\u003ch2 id=\"ddn-faq\"\u003eFrequently Asked Questions\u003c\/h2\u003e\n\u003ch3\u003eWhat is ivermectin and is it approved by the FDA?\u003c\/h3\u003e\n\u003cp\u003eIvermectin is an FDA-approved antiparasitic drug developed by Merck. It earned its developers the 2015 Nobel Prize and is on the WHO Essential Medicines List. However, the FDA has not approved it for treating or preventing COVID-19, and has issued warnings against using it for that purpose.\u003c\/p\u003e\n\u003ch3\u003eWhat evidence does the opinion article cite for ivermectin treating COVID-19?\u003c\/h3\u003e\n\u003cp\u003eThe article cites a study of 115 COVID-19 patients who received one dose of ivermectin. Compared to untreated patients, they had lower rates of pneumonia, oxygen need, ICU admission, and death: 13.3% died versus 24.5%. Hospital stay averaged 9 days versus 15 days. These are from one study, not a definitive trial.\u003c\/p\u003e\n\u003ch3\u003eCan ivermectin help prevent COVID-19 according to the article?\u003c\/h3\u003e\n\u003cp\u003eOne 2020 study gave ivermectin to family members of confirmed COVID-19 patients. Fewer than 8% of treated family members became infected, versus 58.4% of untreated family members. Another study of 200 high-risk healthcare workers found 2% infection in the ivermectin group versus 10% in the control group.\u003c\/p\u003e\n\u003ch3\u003eHow safe is ivermectin based on the article?\u003c\/h3\u003e\n\u003cp\u003eThe article states that since 1998, about four billion doses of ivermectin have been given worldwide, with only 28 reported serious neurological adverse events. That is a serious event rate of less than 0.0000007%. It has also been used safely in pregnant women, children, and infants, according to a 2021 review.\u003c\/p\u003e\n\u003ch3\u003eWhy did the FDA warn against using ivermectin for COVID-19?\u003c\/h3\u003e\n\u003cp\u003eThe FDA issued a warning in 2021 saying people should not use ivermectin for COVID-19, using strong language about danger. The article says this was partly in response to people taking veterinary formulations. The original authors argue the FDA's warning conflicts with ivermectin's long safety record and evidence from clinical trials.\u003c\/p\u003e\n\u003ch3\u003eWhat should a patient do if considering ivermectin for COVID-19?\u003c\/h3\u003e\n\u003cp\u003eTalk to your doctor before taking ivermectin. Never self-prescribe and never use veterinary products, as they can be dangerous. Only use human-approved ivermectin at the correct dose. Discuss prevention if you live with someone infected or work in a high-risk setting, but do not abandon masks, distancing, or vaccination.\u003c\/p\u003e\n\u003ch3\u003eShould I get a second opinion before taking ivermectin for COVID-19, given the FDA warning and the evidence in this article?\u003c\/h3\u003e\n\u003cp\u003eA second opinion can help you weigh the conflicting evidence about ivermectin for COVID-19. The article cites studies showing reduced death rates (13.3% vs. 24.5%) and shorter hospital stays (9 vs. 15 days), but the FDA has not approved it for COVID-19 and warns against its use. Because the evidence is from opinion pieces and observational studies, not definitive trials, a second opinion from an independent expert can clarify whether ivermectin might be appropriate for your situation, especially if you are considering it for prevention or early treatment. Diagnostic Detectives Network provides independent expert second opinions.\u003c\/p\u003e\n\u003c!-- ddn:faq:end --\u003e\n\n\u003ch2 id=\"source\"\u003eSource Information\u003c\/h2\u003e\n\u003cp\u003e\u003cstrong\u003eOriginal article:\u003c\/strong\u003e \"Why Is the FDA Attacking a Safe, Effective Drug?\" by David R. Henderson and Charles L. Hooper\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003ePublication:\u003c\/strong\u003e The Wall Street Journal, Opinion \u0026amp; Commentary, July 28, 2021\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors:\u003c\/strong\u003e David R. Henderson is a research fellow with the Hoover Institution at Stanford University and was senior health economist with President Reagan's Council of Economic Advisers. Charles L. Hooper is president of Objective Insights, a consulting firm for pharmaceutical clients.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCopyright:\u003c\/strong\u003e © 2021 Dow Jones \u0026amp; Company, Inc. All Rights Reserved.\u003c\/p\u003e\n\u003cp\u003e\u003cem\u003eNote: This patient-friendly article is based on a peer-reviewed commentary originally published in a major news outlet. It is not a substitute for professional medical advice. Always consult a qualified healthcare provider before starting, stopping, or changing any treatment.\u003c\/em\u003e\u003c\/p\u003e","brand":"DiagnosticDetectives.Com","offers":[{"title":"Default Title","offer_id":47459138240668,"sku":null,"price":0.0,"currency_code":"DKK","in_stock":true}],"url":"https:\/\/diagnosticdetectives.dk\/products\/ivermectin-and-covid-19-why-some-doctors-say-the-fda-is-ignoring-the-evidence","provider":"DiagnosticDetectives.Com","version":"1.0","type":"link"}