By Mary Beth Pfeiffer
In a widely reported announcement, the U.S. Food and Drug Administration warned, “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.”
Taking the drug “can be very dangerous,” FDA said, though 33 years of human use, billions of doses and a Nobel Prize for annihilating parasitic illness suggest otherwise.
The FDA statement, which is the lynchpin of COVID policies worldwide, purported to protect the public from taking over-the-counter ivermectin meant for animals. But its real purpose was to instill fear.
Indeed, a war on ivermectin — by public health agencies, corporations that stand to cash in on the pandemic, and social and mass media – is being waged to dismiss a drug that could be a lifeline to normalcy.
Confused By The Facts
Ivermectin is a case study in official decrees that do not align with reality.
Take a close look the World Health Organization’s contortions before declaring on March 31 that ivermectin should be limited to experimental trials. WHO first ignored its own commissioned analysis that found the drug would cut COVID deaths by 75 percent. Then, WHO handed the job to a different team, which also found far fewer deaths with ivermectin – but ruled its cherry-picked evidence unconvincing. That is the analysis WHO chose.
Or read the lone study — one among 52 ivermectin trials — that did not find significant evidence of improvement in COVID patients. Despite contradictions and flaws, including some patients given the wrong drug, the results were accepted by the Journal of the American Medical Association.
Scour the list of positive studies, many from countries where this inexpensive drug is reducing illness. Few medical journals will publish them. Though available online, the media ignores them. Major outlets that have not done a single serious story on ivermectin jumped on the told-you-so JAMA story.
Finally, consider that right now, social media is in the midst of a brutal little-reported campaign of censorship to the point that YouTube policy precludes users from saying ivermectin prevents or helps COVID.
Why so rigorously manage the message if the evidence is so weak?
Data Versus The FDA
A website tracker summarizes those 52 ivermectin trials, involving more than 17,500 patients. Collectively, ivermectin:
–Prevented 85 percent of infections (similar to vaccines);
–Resolved 81 percent of early illness;
–Improved 43 percent of late-treated patients;
–Reduced deaths by 76 percent.
As authorities dismiss study after study, it has become clear. The drug’s rejection is not based on science, data or the experience of many doctors. Instead, a disinformation campaign is raging to demonize the drug and belittle studies that support it.
Exhibit #1: The FDA announcement. The agency said in March it had received “multiple reports of patients who have required medical support and been hospitalized” after taking a form of ivermectin used to treat horse parasites.
Among many alarming articles, I could not find any that actually told how many people were “poisoning themselves,” as one report put it. I asked the FDA press office what it meant by “multiple.”
The answer: Four. Three people required hospitalization, though, beyond that, the FDA had no details.
“Some of these cases were lost to follow up, so we can’t be sure of the final outcome,” a spokesperson wrote in an email. “Privacy laws” precluded further comment.
For all we know, the patients might have been sick from COVID, not horse paste, which is regrettably used when patients cannot get the real thing. Ivermectin, incidentally, is FDA-approved and permitted for off-label use, with just 19 associated deaths since 1992, compared to 503 for remdesivir since 2020.
The seeds were nonetheless planted: Ivermectin was an “evolving threat” and “fake COVID treatment,” encouraged by “conspiracy sites trying to push this drug in really high doses.” All based on four cases.
So far, there have been more than 2,500 U.S. deaths after vaccination for COVID-19. I see no hysterical reporting on that.
Exhibit #2: The WHO recommendation. On March 31, the World Health Organization dealt a gut punch to ivermectin, decreeing it should be limited to clinical trials only. But the WHO’s review was limited, questionable and seemingly hastily done.
First, the WHO working group called the evidence that ivermectin reduced deaths of “very low certainty” based on five studies. Why so few?
An independent analysis, also done in March, analyzed 13 studies and found ivermectin decreased the risk of death by 68 percent, an effect that was “consistent across mild to moderate and severe disease subgroups.” The systematic review was led by Dr. Tess Lawrie, a physician and author on 41 Cochrane Reviews, which are routinely used to inform medical guidelines.
In the earlier report that WHO discounted, six mortality studies were examined by the University of Liverpool’s Dr. Andrew Hill — four of which were curiously left out of the second WHO analysis.
Notably, even the studies assessed by the WHO group showed strong reductions in deaths. But the group used unconventional methods to downgrade them, Lawrie said in a YouTube interview. It classified two less-impressive studies as having a low risk of bias, wrongly in Lawrie’s view. That effectively inflated their importance, and helped the review conclude the evidence was lacking.
“You have a risk of death across these studies — in their data — of 70 per thousand, and if you get ivermectin you have a risk of death of 14 per thousand,” Lawrie said in the interview with Dr. John Campbell, a PhD nursing teacher.
That comes to a 72 percent reduction in deaths in patients treated with ivermectin, Lawrie said. But indicative of what Lawrie called a “slapdash” approach, a table of conclusions in the WHO study refers to seven, not five, mortality studies, and to an 81 percent reduction in deaths. “Very strange,” Lawrie said.
Significantly, the review omitted trials analyzed by both Lawrie and Hill that demonstrated significantly fewer deaths: From Egypt (92 percent), Bangladesh (86 percent), Iraq (67 percent) and Turkey (33 percent).
Moreover, the WHO review failed to even look at the strongest evidence in favor of ivermectin: its potential to prevent infection.
Dr. Pierre Kory, president of Front Line COVID-19 Critical Care Alliance, believes that omission was designed to protect the Emergency Use Authorization, which allows administration of unapproved vaccines if no alternative exists. “If ivermectin were to be approved as a standard therapy,” he said in a broadcast to supporters, “…that would kneecap the entire global vaccine policy around the world.”
(Note: I reached out several times to Dr. Bram Rochwerg, co-chair of the WHO analysis. A spokesperson at McMaster University in Canada, where he is an associate professor, said he would have no comment.)
Exhibit #3: The JAMA study. Predictably, the WHO report included the only existing negative ivermectin trial in its review, giving the Cali, Colombia study an inexplicable thumbs-up label of “low risk of bias.”
–With an average age of 37 and lean body mass, the study population was inclined to do well from the get-go — “nebulous parameters,” Schein said, that made statistical relevance negligible. Testament to the robust nature of the group, just one person died in the untreated group, a rate six times lower than locally. Of note, no treated patient died.
–38 people in the control group were accidentally given ivermectin, a serious error, underscoring the letter’s assertion, “The study’s flaws span subject population, design, execution and controls.”
–Participants reported symptoms by telephone, and without objective examination, 16 days after treatment ended, a highly unusual lag time. “Not credible,” the letter said.
Of crucial importance, both patient groups – one got ivermectin and one did not – had almost identical, though minor, side effects, a “striking anomaly” that suggests something, Scheim said. Perhaps ivermectin, which is widely available in Colombia, did not appear to make a significant difference because both groups were taking it. Ivermectin has a bitter taste and 64 placebo patients were given sugar water, compromising a fundamental of controlled trials — that patients cannot discern what treatment they get.
Why would a premier medical journal accept an article with such glaring flaws?
An Organized Campaign
Exhibit #4: Information Management. Everyday, my inbox grows with messages of people who had items removed from Twitter, LinkIn, Facebook and YouTube. Several people were locked out of Twitter for tweets on the results of a registered trial that found ivermectin prevents COVID. I was also locked out of Twitter for eight days after writing the fateful words: “Ivermectin works.”
Aside from a couple of opinion articles in the Wall Street Journal, the media has barely taken notice. Yet this is a clear assault on free expression by outlets that, though privately owned, are essentially monopolies.
“We must never allow anonymous censors to determine what is medical misinformation,” Associate Professor Seymour M. Cohen of Mount Sinai School of Medicine, in a letter to the WSJ, “and cancel scientific inquiry and discussion with which they disagree.”
Although Kory, Lawrie and others are accused of medical “misinformation,” the real problem, Kory says, is disinformation, akin to historical efforts to cover-up the ills of tobacco and other pharmaceutical and government mistakes.
Among the slew of studies that support ivermectin, you will rarely if ever find listed under authors’ potential conflicts of interest the names of pharmaceutical powerhouses like Sanofi Pasteur, GlaxoSmithKline, Janssen, Merck Sharp & Dohme, and Gilead. Yet, each of those was listed on the JAMA article’s COI disclosures.
Merck itself pioneered ivermectin – its chief scientist sharing the Nobel in the process – and has repeatedly said it is a safe, essential medication. Yet Merck disavowed ivermectin for COVID in February in yet another example of how facts do not align with reality. Reuters and others eagerly reported Merck’s statement, but never mentioned the company’s $356-million deal to supply the U.S. government with an “investigational therapeutic.”
The rejection of ivermectin may not be a grand coordinated conspiracy, says Jay Sanchez, an attorney in New York City. Rather, it grows out of something more mundane and insidious that he studied 35 years ago in a course at Harvard Law School taught by later-Supreme Court Justice Stephen G. Bryer: “Regulatory Capture.”
“Regulatory agencies may come to be dominated by the industries or interests they are charged with regulating,” says Investipedia. Hence, they act more on behalf of the companies they regulate than on the public they serve. Blame “regulator complacency, cozy relationships,” wrote economist Fred S. Grygiel, “and ultimately, conflicts of interest.”
Those relationships allow PR campaigns to shape messages, news outlets and social media companies to mercilessly reinforce them, and spineless government agencies go along with the shadows of doubt rather than the robust evidence.
That is ivermectin today.