The FDA’s War Against the Truth on Ivermectin
David R. HendersonDavid R. Henderson
Charles L. HooperCharles L. Hooper
– October 18, 2021Reading Time: 6 minutes
AIER >> Daily Economy >> Science >> Government >> Crisis >> Authoritarianism
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On July 28, the Wall Street Journal ran our article “Why Is the FDA Attacking a Safe, Effective Drug?” In it, we outlined the potential value of the antiparasitic drug ivermectin for Covid-19, and we questioned the FDA’s vigorous attack on ivermectin. Many people praised us and many criticized us. We had clearly covered a sensitive subject. It didn’t help that one of the studies we referenced was retracted shortly before we submitted our article. Within hours of learning that fact, we sent a mea culpa to the Journal’s editors. They acted quickly, adding a note at the end of the electronic version and publishing our letter. It’s important to address two criticisms of our work. The first is that we exaggerated the FDA’s warning on ivermectin. The second is that Merck’s stance on ivermectin proved that even the company that developed ivermectin thought that it doesn’t work for Covid-19.

First, we didn’t exaggerate the FDA’s warning on ivermectin. Instead, the agency changed its website after our article was published, probably to reflect the points we made. Second, Merck had two incentives to downplay ivermectin’s usefulness against the novel coronavirus. We’ll explain both points more fully.

Ivermectin was developed and marketed by Merck & Co. while one of us (Hooper) worked there years ago. Dr. William C. Campbell and Professor Satoshi Omura were awarded the 2015 Nobel Prize for Physiology or Medicine. They earned it for discovering and developing avermectin. Later Campbell and some associates modified avermectin to create ivermectin. Merck & Co. has donated four billion doses of ivermectin to prevent river blindness and other diseases in areas of the world, such as Africa, where parasites are common. The ten doctors who are in the Front Line Covid-19 Critical Care Alliance call ivermectin “one of the safest, low-cost, and widely available drugs in the history of medicine.” Ivermectin is on the WHO’s List of Essential Medicines and ivermectin has been used safely in pregnant women, children, and infants.

Ivermectin is an antiparasitic, but it has shown, in cell cultures in laboratories, the ability to destroy 21 viruses, including SARS-CoV-2, the cause of Covid-19. Further, ivermectin has demonstrated its potential in clinical trials for the treatment of Covid-19 and in large-scale population studies for the prevention of Covid-19.

Contradicting these positive results, the FDA issued a special statement warning that “you should not use ivermectin to treat or prevent 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. In fact, the FDA had already approved the drug years ago as a safe and effective anti-parasitic. Why would it suddenly become dangerous if used to treat Covid-19? Further, the FDA claimed, with no scientific basis, that ivermectin is not an antiviral, notwithstanding its proven antiviral activity.

Interestingly, at the bottom of the FDA’s strong warning against ivermectin was this 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.” Was this based on the kinds of double-blind studies that the FDA requires for drug approvals? No.

After some critics claimed that we overstated or overreacted to the FDA’s special warning, we reviewed the FDA’s website and found that it had been changed, and there was no mention of the changes nor any reason given. Overall, the warnings were watered down and clarified. We noticed the following changes:

The false statement that “Ivermectin is not an anti-viral (a drug for treating viruses)” was removed.
“Taking a drug for an unapproved use can be very dangerous. This is true of ivermectin, too” was changed to the less alarming “Ivermectin has not been shown to be safe or effective for these indications.” (Indications is the official term used in the industry to denote new uses for a drug, such as new diseases or conditions, and/or new patient populations.)
The statement, “If you have a prescription for ivermectin for an FDA-approved use, get it from a legitimate source and take it exactly as prescribed,” was changed to, “If your health care provider writes you an ivermectin prescription, fill it through a legitimate source such as a pharmacy, and take it exactly as prescribed.” This more clearly acknowledges that reasonable physicians may prescribe ivermectin for non-FDA-approved uses, such as Covid-19.
The ending statement about masks, spacing, hand washing, and avoiding crowds was replaced with one that recommended getting vaccinated and following CDC guidelines.
The reasonable statement “Talk to your health care provider about available COVID-19 vaccines and treatment options. Your provider can help determine the best option for you, based on your health history” was added at the end.
The new warning from the FDA is more correct and less alarming than the previous one.

In a statement from February, Merck, the company that originated and still sells ivermectin, agreed with the FDA that ivermectin should not be used for Covid-19. “We do not believe that the data available support the safety and efficacy of ivermectin beyond the doses and populations indicated in the regulatory agency-approved prescribing information.”[2]

To some, this appeared to be a smoking gun. Merck wants to make money, they reason, and people are interested in using ivermectin for Covid-19, therefore, Merck would warn against such usage only if the scientific evidence were overwhelming. But that’s not how the pharmaceutical industry works.

Here’s how the FDA-regulated pharmaceutical industry really works.

The FDA judges all drugs as guilty until proven, to the FDA’s satisfaction, both safe and efficacious. By what process does this happen? The FDA waits for a deep-pocketed sponsor to present a comprehensive package that justifies the approval of a new drug or a new use of an existing drug. For a drug like ivermectin, long since generic, a sponsor may never show up. The reason is not that the drug is ineffective; rather, the reason is that any expenditures used to secure approval for that new use will help other generic manufacturers that haven’t invested a dime. Due to generic drug substitution rules at pharmacies, Merck could spend millions of dollars to get a Covid-19 indication for ivermectin and then effectively get zero return. What company would ever make that investment?

With no sponsor, there is no new FDA-approved indication and, therefore, no official recognition of ivermectin’s value. Was the FDA’s warning against ivermectin based on science? No. It was based on process. Like a typical bureaucrat, the FDA won’t recommend the use of ivermectin because, while it might help patients, such a recommendation would violate its processes. The FDA needs boxes checked off in the right order. If a sponsor never shows up and the boxes aren’t checked off, the FDA’s standard approach is to tell Americans to stay away from the drug because it might be dangerous or ineffective. Sometimes the FDA is too enthusiastic and these warnings are, frankly, alarming. Guilty until proven innocent.

There are two reasons that Merck would warn against ivermectin usage, essentially throwing its own drug under the bus.

Once they are marketed, doctors can prescribe drugs for uses not specifically approved by the FDA. Such usage is called off-label. Using ivermectin for Covid-19 is considered off-label because that use is not specifically listed on ivermectin’s FDA-approved label.

While off-label prescribing is widespread and completely legal, it is illegal for a pharmaceutical company to promote that use. Doctors can use drugs for off-label uses and drug companies can supply them with product. But heaven forbid that companies encourage, support, or promote off-label prescribing. The fines for doing so are outrageous. During a particularly vigorous two-year period, the Justice Department collected over $6 billion from drug companies for off-label promotion cases. Merck’s lawyers haven’t forgotten that lesson.

Another reason for Merck to discount ivermectin’s efficacy is a result of marketing strategy. Ivermectin is an old, cheap, off-patent drug. Merck will never make much money from ivermectin sales. Drug companies aren’t looking to spruce up last year’s winners; they want new winners with long patent lives. Not coincidentally, Merck recently released the clinical results for its new Covid-19 fighter, molnupiravir, which has shown a 50% reduction in the risk of hospitalization and death among high-risk, unvaccinated adults. Analysts are predicting multi-billion-dollar sales for molnupiravir.[3]

While we can all be happy that Merck has developed a new therapeutic that can keep us safe from the ravages of Covid-19, we should realize that the FDA’s rules give companies an incentive to focus on newer drugs while ignoring older ones. Ivermectin may or may not be a miracle drug for Covid-19. The FDA doesn’t want us to learn the truth.

The FDA spreads lies and alarms Americans while preventing drug companies from providing us with scientific explorations of existing, promising, generic drugs.

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David R. Henderson
David R. Henderson
David R. Henderson is a Senior Fellow with the American Institute for Economic Research.

He is also a research fellow with the Hoover Institution at Stanford University and emeritus professor of economics with the Naval Postgraduate School, is editor of The Concise Encyclopedia of Economics.

David was previously the senior economist for health policy with President Reagan’s Council of Economic Advisers.

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Charles L. Hooper
Charles L. Hooper
Charles L. Hooper is President and co-founder of Objective Insights, Inc. He is also the author of Would the FDA Reject Itself? (Chicago Park Press, 2021), currently available as an ebook on Apple Books and Amazon Kindle. A paper version is forthcoming.

Prior to forming Objective Insights in 1994, he worked at Merck & Co., Syntex Labs, and NASA.

He is a former visiting fellow at the Hoover Institution at Stanford University.

His experience is in decision analysis, economics, product pricing, forecasting, and modeling.

The Biden administration on Wednesday unveiled its plan to 'quickly' vaccinate roughly 28 million children age 5-11, pending authorization from the Food and Drug Administration (FDA).

https://www.zerohedge.com/covid-19/white...n-age-5-11

CNN is reporting that a new study involving over 600,000 veterans has found that Johnson & Johnson’s covid vaccine’s protection “fell from 88% in March to 3% in August.”

“A study published Thursday reported a steep decline in vaccine effectiveness against infection by August of this year, especially for people who received the J&J vaccine,” CNN reported over the weekend. “The researchers found that among more than 600,000 veterans, J&J’s vaccine’s protection fell from 88% in March to 3% in August.”

As there are no requirements (yet) that people be triple-jabbed — or double-jabbed in the case of J&J’s shot — this means millions of Americans are getting fired for not having taken a shot that’s now 3% effective.

On the flip side, we know from another Israeli study that “vaccinated individuals had 27 times higher risk of symptomatic COVID infection compared to those with natural immunity from prior COVID disease,” as epidemiologist Martin Kulldorff noted.

That Israeli study, which was done between June 1 and August 14, involved only Pfizer recipients.

The new study of vets in America showed that Pfizer’s effectiveness declined to 50% in August from 91% and Moderna’s fell to 64% from 92%. That suggests natural immunity is now more than a hundred times more effective than J&J’s vaccine, yet the federal government and most companies do not even recognize natural immunity as a justification not to get vaxxed.

Christopher Steele: Trump Pee Tape 'Probably Exists' (businessinsider.com)

Quote:Christopher Steele, the former British spy behind a heavily disputed dossier on Donald Trump, said he believed an infamous "pee tape" of Trump does indeed exist.

In an interview with ABC News, he speculated that Russia may have kept the tape hidden because Trump offered them "pretty good value" during his time in office.

Blaming their low vaccination rate.

Quote:MOSCOW (AP) — Dr. Georgy Arbolishvili doesn’t need to see government statistics or hear about the records being broken every day for infections and deaths to know that Russia is struggling through a particularly alarming phase of the coronavirus pandemic.

He simply looks around his filled-to-capacity intensive care unit at Moscow’s Hospital No. 52.

With only about a third of Russia’s 146 million people vaccinated against COVID-19, the country has hovered near 1,000 reported deaths per day for weeks and surpassed it on Saturday — a situation that Arbolishvili says “causes despair.”

“The majority of ICU patients in grave condition are unvaccinated,” he told The Associated Press. These illnesses “could have been very easily avoided if a person had been vaccinated.”

October 17, 2021
Nebraska AG's devastating critique of the suppression of effective COVID therapies
By Jarrad Winter
Legal opinions usually aren't terribly fun to read, but if you've been an ivermectin and/or hydroxychloroquine advocate for use against Wuhan Plague, this one definitely will bring you much joy.

It's a rather lengthy and full spectrum opinion issued by Doug Peterson, Nebraska's Attorney General, in response to a query from the state's Department of Health and Human Services as to whether physicians can be persecuted and tormented for prescribing ivermectin or hydroxychloroquine to patients sick with the China Flu. What the AG's response amounts to is a full and complete takedown of the conspiracy to suppress cheap and effective early Covid-19 treatments.



All the players -- FDA, CDC, Fauci, Big Pharma, the media, all of them -- get a glorious and swift kick in the rear end. Portions of it even made me laugh out loud. As far as legal documents go, it's definitely easy reading and understandable to everyone. It seems clear that the AG's office went to some trouble to layout the whole saga in a way the masses can understand without translation by legal scholars.

What follows are some of the most relevant parts (at least in my sometimes-humble opinion), but it really is in everyone's best interest to personally read the opinion in full. People must individually understand what's actually happening for themselves. This is what will enable We The People to course correct and divert from the ruinous path set for us by the overlords.

As to the question of ivermectin as a treatment option:

The Mahmud study–a CRT that explored ivermectin as an early treatment for 363 individuals–concluded that “patients with mild-to-moderate COVID-19 infection treated with ivermectin plus doxycycline recovered earlier, were less likely to progress to more serious disease, and were more likely to be COVID-19 negative on day 14. And Niaee’s research team found that ivermectin can help even hospitalized patients. That group conducted a “randomized, double-

blind, placebo-controlled, multicenter clinical trial” with 180 hospitalized patients diagnosed with COVID-19. They concluded that ivermectin “reduces the rate of mortality and duration of hospitalization in adult COVID-19 patients,” and the improvement of other clinical parameters showed that the ivermectin, with a wide margin of safety, had a high therapeutic effect on COVID-19.

What initially made ivermectin a target for all the inexplicable slander?

Why would ivermectin’s original patent holder go out of its way to question this medicine by creating the impression that it might not be safe? There are at least two plausible reasons. First, ivermectin is no longer under patent, so Merck does not profit from it anymore. That likely explains why Merck declined to “conduct clinical trials” on ivermectin and COVID-19 when given the chance. Second, Merck has a significant financial interest in the medical profession rejecting ivermectin as an early treatment for COVID-19.

As to the question of hydroxychloroquine as a treatment option:

In 2004, long before the COVID-19 pandemic began, a lab study revealed that chloroquine "is an effective inhibitor of the replication of the severe acute respiratory syndrome coronavirus (SARS-CoV) in vitro" and thus that it should be "considered for immediate use in the prevention and treatment of SARS-CoV infections". The following year, another paper explained that "chloroquine has strong antiviral effects on SARS-CoV" and "is effective in preventing the spread of SARS[-]CoV in cell culture."

It is widely recognized in the medical community that hydroxychloroquine is generally safe, so safe in fact that it may be prescribed to pregnant women and "children of all ages."

What made hydroxychloroquine controversial in the first place?

A striking example features one of the world’s most prestigious medical journals–the Lancet. In the middle of the COVID-19 pandemic, the Lancet published a paper denouncing hydroxychloroquine as dangerous. Yet the reported statistics were so flawed that journalists and outside researchers immediately began raising concerns. Then after one of the authors refused to provide the analyzed data, the paper was retracted, but not before many countries stopped using hydroxychloroquine and trials were cancelled or interrupted. The Lancet’s own editor in chief admitted that the paper was a “fabrication, a monumental fraud,” and “a shocking example of research misconduct in the middle of a global health emergency."

Interesting note about ivermectin and hydroxychloroquine hesitancy:

As for professional associations' and physician groups' views on hydroxychloroquine, it appears they generally adopt the same position they did on ivermectin. Those like the AAPS who support ivermectin as an option for early COVID-19 treatment generally support hydroxychloroquine too, while those like the AMA, APhA, and ASHP that oppose one typically resist the other.

The AG's conclusion:

Allowing physicians to consider these early treatments will free them to evaluate additional tools that could save lives, keep patients out of the hospital, and provide relief for our already strained healthcare system.

Ireland: Two Counties With 99.7% And 98%+ ‘Fully Vaccinated’ See Massive Covid ‘Outbreaks’
https://humansarefree.com/2021/10/irelan...reaks.html

Antibody dependent enhancement: Unavoidable problems in vaccine development
Look into it.

The Proud Boys Complain About Being Single and I Wonder Why (themarysue.com)

Quote:HEY LAAAAAAAAAAAAADIES! Are you single and ready to mingle? Do you like your men misogynistic, homophobic, and fascist? Are you looking to live out your Donna Reed fantasy in some dude’s mom’s basement? Then good news! The Proud Boys are on the hunt for their future wives!

At a “Fall Love Fest” rally in Los Angeles this past weekend, a pack of Proud Boys took a break from chanting “F-ck Antifa!” to let the sparse crowd know that many of them are single and “looking for housewives.” It’s amazing that these gents are single. You mean no woman has signed up for a lifetime of cooking, cleaning, and providing sex for these red-pilled cult members? Color us shocked.

I learned something today from this forum ! Might be the first time.

Did not know that "Brown Sugar" from the Stones was actually slated to be "Black Pussy". I'll be damned

After a little looking around I found out that I really didn't even know the lyrics. The Rolling Stones were not one of my favorite bands and Brown Sugar was one of their worst songs, but I paid attention to things like that back in the day. I owned the album it was on.

Just goes to show you the old axiom that lyrics really aren't that important to Rock and Roll is true.


Speaking of the Rolling Stones. I thought Paul McCartney's recent comment about the Stones being a "blues cover band" to be somewhat true, At least compared to the Beatles.