Brownstone Institute
Setting the Record Straight on Ivermectin
From the Brownstone Institute
The COVID-19 pandemic brought us a panoply of lies and evidence-light declarations that were less intended to inform Americans than to consolidate power and buy time. Among these were Anthony Fauci’s famous shift from arguing against wearing masks, to recommending wearing one, and, finally, to wearing two.
Fauci also tried to convince us that the SARS-CoV-2 virus was not manipulated in a lab even though his inner circle had emailed him about “unusual features” of the virus that looked “potentially engineered.” And, of course, we had “fifteen days to stop the spread,” an evergreen concept that dragged on for two years. Lest readers fault us for forgetting, there was also the “gain of function” controversy, the focused protection battle, school closures, lockdowns, vaccine mandates, and vaccine misrepresentations.
These topics have received much public attention. The one pandemic topic that hasn’t, and is nonetheless important, is the maligned ivermectin. It’s time to set the record straight.
If you’ve followed the news closely over the last two years, you’ve probably heard a few things about ivermectin. First, that it’s a veterinary medicine intended for horses and cows. Second, that the FDA and other government regulatory agencies recommended against its use for COVID-19. Third, that even the inventor and manufacturer of ivermectin, Merck & Co., came out against it. Fourth, that one of the largest studies showing that ivermectin worked for COVID-19 was retracted for data fraud. And, finally, that the largest and best study of ivermectin, the TOGETHER trial, showed that ivermectin didn’t work.
Let’s consider the evidence.
Ivermectin has a distinguished history, and it may have benefits comparable to those of penicillin. The anti-parasitic’s discovery led to a Nobel Prize and subsequent billions of safe administrations around the world, even among children and pregnant women. “Ivermectin is widely available worldwide, inexpensive, and one of the safest drugs in modern medicine.”
The FDA put out a special warning against using ivermectin for COVID-19. The FDA’s warning, which included language such as, “serious harm,” “hospitalized,” “dangerous,” “very dangerous,” “seizures,” “coma and even death,” and “highly toxic,” might suggest that the FDA was warning against pills laced with poison, not a drug the FDA had already approved as safe. Why did it become dangerous when used for COVID-19? The FDA didn’t say.
Because of the FDA’s rules, if it were to make any statement on ivermectin, it was obliged to attack it. The FDA prohibits the promotion of drugs for unapproved uses. Since fighting SARS-CoV-2 was an unapproved use of ivermectin, the FDA couldn’t have advocated use without obvious hypocrisy. Ivermectin’s discoverer, Merck & Co., had multiple reasons to disparage its own drug.
Merck, too, couldn’t have legally “promoted” ivermectin for COVID-19 without a full FDA approval, something that would have taken years and many millions of dollars. Plus, Merck doesn’t make much money from cheap, generic ivermectin but was hoping to find success with its new, expensive drug, Lagevrio (molnupiravir).
A large study of ivermectin for COVID-19 by Elgazzar et al. was withdrawn over charges of plagiarism and faked data. Many media reports seem fixated on this one dubious study, but it was one of many clinical studies. After the withdrawn studies have been removed from consideration, there are 15 trials that suggest that ivermectin doesn’t work for COVID-19 and 78 that do.
The TOGETHER trial received significant positive press. The New York Times quoted two experts who had seen the results. One stated, “There’s really no sign of any benefit [from ivermectin],” while the other said, “At some point it will become a waste of resources to continue studying an unpromising approach.”
While the Elgazzar paper was quickly dismissed, the TOGETHER trial was acclaimed. It shouldn’t have been. Researchers who have analyzed it have found 31 critical problems (impossible data; extreme conflicts of interest; blinding failure), 22 serious problems (results were delayed six months; conflicting data), and 21 major problems (multiple, conflicting randomization protocols) with it.
While the popular narrative is that the TOGETHER trial showed that ivermectin didn’t work for COVID-19, the actual results belie that conclusion: ivermectin was associated with a 12 percent lower risk of death, a 23 percent lower risk of mechanical ventilation, a 17 percent lower risk of hospitalization, and a 10 percent lower risk of extended ER observation or hospitalization. We have calculated that the probability that ivermectin helped the patients in the TOGETHER trial ranged from 26 percent for the median number of days to clinical recovery to 91 percent for preventing hospitalization. The TOGETHER trial’s results should be reported accurately.
Based on the clinical evidence from the 93 trials that ivermectin reduced mortality by an average of 51 percent, and on the estimated infection fatality rate of COVID-19, about 400 infected Americans aged 60-69 would need to be treated with ivermectin to statistically prevent one death in that group. The total cost of the ivermectin to prevent that one death: $40,000. (Based on the GoodRx website, a generic prescription for ivermectin is priced at approximately $40. Roughly 2.5 prescriptions would be needed per person to receive the average dose of 150 mg per patient.)
How much is your life worth? We’re betting it’s worth far more than $40,000.
When the next pandemic strikes, by necessity we’ll rely on older drugs because newer ones require years of development. Ivermectin is a repurposed drug that helps, and could have helped so much more. It deserves recognition, not disparagement. What we really need, however, is a way to inoculate ourselves against the lies and misrepresentations of powerful public figures, organizations, and drug companies. Sadly, there are no such vaccines for that contagion.
Authors
From the Brownstone Institute
This article was co-authored with Mary Beth Pfieffer.
In a seismic political shift, Republicans have laid claim to an issue that Democrats left in the gutter—the declining health of Americans. True, it took a Democrat with a famous name to ask why so many people are chronically ill, disabled, and dying younger than in 47 other countries. But the message resonated with the GOP.
We have a proposal in this unfolding milieu. Let’s have a serious, nuanced discussion. Let’s retire labels that have been weaponized against Robert F. Kennedy, Jr., nominated for Health and Human Services Secretary, and many people like him.
Start with discarding threadbare words like “conspiracy theory,” “anti-vax,” and the ever-changing “misinformation.”
These linguistic sleights of hand have been deployed—by government, media, and vested interests—to dismiss policy critics and thwart debate. If post-election developments tell us anything, it is that such scorn may no longer work for a population skeptical of government overreach.
Although RFK has been lambasted for months in the press, he just scored a 47 percent approval rating in a CBS poll.
Americans are asking: Is RFK on to something?
Perhaps, as he contends, a 1986 law that all but absolved vaccine manufacturers from liability has spawned an industry driven more by profit than protection.
Maybe Americans agree with RFK that the FDA, which gets 69 percent of its budget from pharmaceutical companies, is potentially compromised. Maybe Big Pharma, similarly, gets a free pass from the television news media that it generously supports. The US and New Zealand, incidentally, are the only nations on earth that allow “direct-to-consumer” TV ads.
Finally, just maybe there’s a straight line from this unhealthy alliance to the growing list of 80 childhood shots, inevitably approved after cursory industry studies with no placebo controls. The Hepatitis B vaccine trial, for one, monitored the effects on newborns for just five days. Babies are given three doses of this questionably necessary product—intended to prevent a disease spread through sex and drug use.
Pointing out such conflicts and flaws earns critics a label: “anti-vaxxer.”
Misinformation?
If RFK is accused of being extreme or misdirected, consider the Covid-19 axioms that Americans were told by their government.
The first: The pandemic started in animals in Wuhan, China. To think otherwise, Wikipedia states, is a “conspiracy theory,” fueled by “misplaced suspicion” and “anti-Chinese racism.”
Not so fast. In a new 520-page report, a Congressional subcommittee linked the outbreak to risky US-supported virus research at a Wuhan lab at the pandemic epicenter. After 25 hearings, the subcommittee found no evidence of “natural origin.”
Is the report a slam dunk? Maybe not. But neither is an outright dismissal of a lab leak.
The same goes for other pandemic dogma, including the utility of (ineffective) masks, (harmful) lockdowns, (arbitrary) six-foot spacing, and, most prominently, vaccines that millions were coerced to take and that harmed some.
Americans were told, wrongly, that two shots would prevent Covid and stop the spread. Natural immunity from previous infection was ignored to maximize vaccine uptake.
Yet there was scant scientific support for vaccinating babies with little risk, which few other countries did; pregnant women (whose deaths soared 40 percent after the rollout), and healthy adolescents, including some who suffered a heart injury called myocarditis. The CDC calls the condition “rare;” but a new study found 223 times more cases in 2021 than the average for all vaccines in the previous 30 years.
Truth Muzzled?
Beyond this, pandemic decrees were not open to question. Millions of social media posts were removed at the behest of the White House. The ranks grew both of well-funded fact-checkers and retractions of countervailing science.
The FDA, meantime, created a popular and false storyline that the Nobel Prize-winning early-treatment drug ivermectin was for horses, not people, and might cause coma and death. Under pressure from a federal court, the FDA removed its infamous webpage, but not before it cleared the way for unapproved vaccines, possible under the law only if no alternative was available.
An emergency situation can spawn official missteps. But they become insidious when dissent is suppressed and truth is molded to fit a narrative.
The government’s failures of transparency and oversight are why we are at this juncture today. RFK—should he overcome powerful opposition—may have the last word.
The conversation he proposes won’t mean the end of vaccines or of respect for science. It will mean accountability for what happened in Covid and reform of a dysfunctional system that made it possible.
Republished from RealClearHealth
Author
From the Brownstone Institute
The only way to restore public trust in vaccination – which has taken a big hit since the lies attending the rollout of the Covid-19 vaccine – is to put a well-known vaccine skeptic in charge of the vaccine research agenda. The ideal person for this is Robert F. Kennedy, Jr., who has been nominated to lead the Department of Health and Human Services.
At the same time, we must put rigorous scientists with a proven track record of evidence-based medicine in charge of determining the type of study designs to use. Two ideal scientists for this are Dr. Jay Bhattacharya and Dr. Marty Makary, who have been nominated to lead the NIH and FDA, respectively.
Vaccines are – along with antibiotics, anesthesia, and sanitation – one of the most significant health inventions in history. First conceived in 1774 by Benjamin Jesty, a farmer in Dorsetshire, England, the smallpox vaccine alone has saved millions of lives. Operation Warp Speed, which rapidly developed the Covid vaccines, saved many older Americans. Despite this, we have seen a sharp increase in general vaccine hesitancy. Vaccine scientists and public health officials who did not conduct properly randomized trials made false claims about vaccine efficacy and safety and established vaccine mandates for people who did not need the vaccines, sowing suspicion and damaging public trust in vaccination.
What went wrong? The purpose of the Covid vaccines was to reduce mortality and hospitalization, but the randomized trials were only designed to demonstrate short-term reduction in Covid symptoms, which is not of great public health importance. Since the placebo groups were promptly vaccinated after the emergency approval, they also failed to provide reliable information about adverse reactions. Despite these flaws, it was falsely claimed that vaccine-induced immunity is superior to natural infection-acquired immunity and that the vaccines would prevent infection and transmission.
Governments and universities then mandated the vaccines for people with superior natural immunity and for young people with very low mortality risk. These mandates were not only unscientific but with a limited vaccine supply, it was unethical to vaccinate low-mortality-risk people when the vaccines were needed by older high-risk people around the world.
Since government and pharmaceutical companies lied about the Covid vaccine, are they also lying about other vaccines? Skepticism has now spread to tried-and-true vaccines that are proven to work.
And there are real, unanswered vaccine safety questions. Seminal work from Denmark has shown that vaccines can have both positive and negative non-specific effects on non-targeted diseases, and that is something that must be explored in greater depth. Vaccine Safety Datalink (VSD) scientists studying asthma and aluminum-containing vaccines concluded that while their “findings do not constitute strong evidence for questioning the safety of aluminum in vaccines…additional examination of this hypothesis appears warranted.”
While VSD and other scientists should continue to do observational studies, we should also conduct randomized placebo-controlled vaccine trials, as RFK has advocated. Since we have herd immunity for many diseases, such as measles, trials can be ethically conducted by randomizing the age of vaccination to, for example, one versus three years old, while spreading the trial over a large geographical area so that the unvaccinated are not all living close to each other.
I am confident that most vaccines will continue to be found safe and effective. While some problems may be found, that is more likely to increase rather than decrease vaccine confidence. For instance, it was found that the measles-mumps-rubella-varicella (MMRV) vaccine causes excess febrile seizures in 12- to 23-month-old children. MMRV is now only given as a second dose to older children, while the younger kids get separate MMR and varicella vaccines, resulting in fewer vaccine-induced seizures that scare parents. Although safety studies were inconclusive, it was also wise to remove mercury from vaccines. Even if we end up with fewer vaccines in the recommended vaccine schedule, that’s not necessarily a terrible thing. Scandinavia has a very healthy population with fewer vaccines in their schedules.
We won’t restore vaccine confidence by preaching to the choir. After the Covid debacle, Kennedy’s stated goal is to return to evidence-based medicine free from conflicts of interest. Letting him do that is the only way that skeptics will trust vaccines again, and those of us who trust vaccines have no reason to be afraid of that.
Attempts by the public health and pharma establishments to derail the nominations of RFK, Bhattacharya, and Makary are the surest way to further increase vaccine hesitancy in America. The choice is stark. We cannot let lopsided “pro-vaccine scientists” who clamp their hands over their ears at the mildest questions do any more harm to vaccine confidence. As a pro-vaccine scientist, and in fact, the only person ever being fired by the CDC for being too pro-vaccine, the choice is clear in my mind. To restore vaccine confidence to previous levels, we must support the nominations of Kennedy, Bhattacharya, and Makary.
Republished from RealClearPolitics
Author
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