Ivermectin and COVID-19: Why Some Doctors Say the FDA Is Ignoring the Evidence

Table of Contents

• Key Points
• Background: A Heated Dispute Over an Old Drug
• What Is Ivermectin? A Proven Medicine With a Nobel Prize Pedigree
• Evidence for Treating COVID-19: Numbers From Clinical Trials
• Evidence for Preventing COVID-19: Protecting Families and Healthcare Workers
• Safety Record: Four Billion Doses and Only 28 Serious Events
• The FDA's Position: Warnings vs. Mask Recommendations
• Limitations: What This Opinion Piece Can and Cannot Prove
• Clinical Implications: What This Means for Patients
• Recommendations: What Should You Do?
• Frequently Asked Questions
• Source Information

Key Points

• The article is an opinion piece, not a peer-reviewed scientific study.
• In one 115-patient study, ivermectin reduced deaths from 24.5% to 13.3%.
• A prevention study showed 8% infection in treated family members vs. 58.4% untreated.
• Four billion ivermectin doses have had only 28 serious adverse events reported.
• The FDA has not approved ivermectin for COVID-19 and warns against its use.

Background: A Heated Dispute Over an Old Drug

The 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.

Earlier 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.

But 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.

What Is Ivermectin? A Proven Medicine With a Nobel Prize Pedigree

Ivermectin was developed and marketed by the pharmaceutical company Merck & Co. One of the original article's co-authors, Charles L. Hooper, worked at Merck during the drug's development years.

The science behind ivermectin earned its developers the 2015 Nobel Prize in Physiology or Medicine. 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.

Ivermectin appears on the World Health Organization's List of Essential Medicines—a catalog of the safest and most effective medicines needed in a health system. Merck has donated four billion doses of ivermectin to prevent river blindness and other parasitic diseases in Africa and other regions where parasites are common.

A group of ten doctors calling themselves the Front Line Covid-19 Critical Care Alliance (FLCCC) have publicly stated that ivermectin is "one of the safest, low-cost, and widely available drugs in the history of medicine."

Evidence for Treating COVID-19: Numbers From Clinical Trials

According to the original article, ivermectin fights 21 viruses, including SARS-CoV-2, the virus that causes COVID-19. Laboratory research published in June 2020 in the journal Antiviral Research showed that a single dose reduced the viral load (the amount of virus in cells) by 99.8% in 24 hours and by 99.98% in 48 hours.

The authors state that 70 clinical trials 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.

Here are the key numbers from one study involving 115 patients with COVID-19 who received a single dose of ivermectin:

• Pneumonia or cardiovascular complications: 0% in the ivermectin group vs. 11.4% in the control (untreated) group.
• Respiratory distress: 2.6% vs. 15.8%.
• Need for oxygen: 9.6% vs. 45.9%.
• Need for antibiotics: 15.7% vs. 60.2%.
• Intensive care admission: 0.1% vs. 8.3%.
• Time to test negative: 4 days vs. 15 days.
• Average hospital stay: 9 days vs. 15 days.
• Mortality (death rate): 13.3% vs. 24.5%.

These 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.

Evidence for Preventing COVID-19: Protecting Families and Healthcare Workers

The original article also cites evidence that ivermectin can help prevent COVID-19 infection, not just treat it. One 2020 study published in Biochemical and Biophysical Research Communications examined what happened when ivermectin was given to family members of confirmed COVID-19 patients.

The results were dramatic:

• Less than 8% of treated family members became infected.
• By contrast, 58.4% of untreated family members became infected.

Another study looked at 200 healthcare workers and others at high risk of exposure. Among those given ivermectin, only 2% developed COVID-19. Among those in the control group, 10% developed the disease. That means ivermectin appeared to reduce the infection rate by five-fold in this high-risk group.

These 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.

Safety Record: Four Billion Doses and Only 28 Serious Events

Despite 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:

• Since 1998, an estimated four billion doses of ivermectin have been administered worldwide.
• There have been only 28 cases of serious neurological adverse events reported, according to an article published in 2021 in the American Journal of Therapeutics.
• The same study found that ivermectin has been used safely in pregnant women, children, and infants.

To 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.

The 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.

The FDA's Position: Warnings vs. Mask Recommendations

At 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."

The 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.

This 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.

Limitations: What This Opinion Piece Can and Cannot Prove

It is essential to note that this article is an opinion commentary, 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.

Additionally, 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.

The 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.

Clinical Implications: What This Means for Patients

If the evidence presented in the original article is accurate, patients with COVID-19 could potentially benefit from ivermectin in several meaningful ways:

• Lower risk of pneumonia and cardiovascular complications.
• Reduced need for oxygen and antibiotics.
• Fewer intensive care admissions.
• Shorter hospital stays (9 days vs. 15 days).
• Lower risk of death (13.3% vs. 24.5%).
• Possible protection for family members and healthcare workers.

However, 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.

It is important to understand that self-medicating with ivermectin—especially with veterinary formulations—can be dangerous. 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.

Recommendations: What Should You Do?

The original article does not provide specific patient instructions, but its conclusions suggest the following reasonable steps for anyone considering ivermectin for COVID-19:

1. Talk to your doctor. 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.
2. Only use human-approved ivermectin. Never take products intended for animals. The dose and formulation matter enormously.
3. Consider the evidence for prevention. 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.
4. Do not abandon proven measures. 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.
5. Stay informed. The debate over ivermectin evolved rapidly. Look for updated guidance from major health organizations, and ask your doctor about the latest trial results.

The 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.

Frequently Asked Questions

What is ivermectin and is it approved by the FDA?

Ivermectin 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.

What evidence does the opinion article cite for ivermectin treating COVID-19?

The 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.

Can ivermectin help prevent COVID-19 according to the article?

One 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.

How safe is ivermectin based on the article?

The 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.

Why did the FDA warn against using ivermectin for COVID-19?

The 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.

What should a patient do if considering ivermectin for COVID-19?

Talk 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.

Should I get a second opinion before taking ivermectin for COVID-19, given the FDA warning and the evidence in this article?

A 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.

Source Information

Original article: "Why Is the FDA Attacking a Safe, Effective Drug?" by David R. Henderson and Charles L. Hooper

Publication: The Wall Street Journal, Opinion & Commentary, July 28, 2021

Authors: 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.

Copyright: © 2021 Dow Jones & Company, Inc. All Rights Reserved.

Note: 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.