Posted on 10/19/2021 9:56:08 PM PDT by SeekAndFind
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 It didn’t help that one of the studies we referenced was retracted shortly before we submitted our article.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 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.
Ping for your interest
Never let the truth get in the way of the agenda.
Never let the Science get in the way of the Agenda.
Well said.
also
Never let your past opposite positions on an issue get in the way of the agenda
Because ivermectin was a miracle drug, it was awesome before covid-19
I would love to see one damn set of full clinical trials to get the use of ivermectin approved in the treatment of COVID-19 (DELTA). However, the problem with ivermectin and other alternate treatments is it requires a tremendously expensive procedure (clinical trials) to get them approved for use. The major pharmaceuticals are not apt to finance it given the financial situation. To get the financing you will need an organized effort and that could open up the door to people taking the money to their offshore banks (like Clinton did with the Haiti relief money).
I'd like to know what those 20 other viruses are.
I had my brother pick up a bottle I had ordered. It’s at his house in a cool “just in case I need it” location. I tried to order another one . . . they canceled my order. Trying for the pills now.
It’s already approved. It’s just not approved specifically for covid on the label. But that shouldn’t matter either because it has long been accepted by the FDA, doctors and pharmacists that an approved drug may be used for other ailments it wasn’t specifically approved for (so-called “off label uses”). All that went out the window as covid was weaponized and politicized.
You are absolutely right, and the authors of this article missed one important point at least in this piece. True there is no financial sponsor willing to investigate it and run a good clean trial because it is a cheap generic. They won’t get their investment back (and given the politics they might not even get the political support to conduct the study). But that too doesn’t matter. Taxpayers shelled out hundreds of billions of dollars to fight this virus. We could have put a few million to enroll an ivermectin trial using so-called surrogate markers such as viral load, time to negative test, oxygen levels, chest x-rays and other data points that would show (or not) evidence of efficacy. If that worked we could have started using it, and/or run a second larger confirmatory trial. It would have taken just a few weeks. We had millions of cases out there. Take 1000 people with positive covid test, randomize them into 2 balanced groups (balanced by age, sex, severity of disease etc) and give half of them IVM. See which group turns out better at days 1, 3, 5, 7, 10, 14. That is “science”.
There was a small study that did basically that. I think it was in Israel but not sure. They had people who flew into the airport and stopped because of symptoms or exposure. They were put into quarantine hotels. Some researchers gave IVM to half of those quarantined. They cleared the virus from their system some 2.5x faster than the non-IVM group.
What these jerks in charge of our policy did was actively subvert science for their own enrichment, ego and political power.
The key is to always treat early. You don’t go to the hospital with a broken leg only to be told to go home and come back if it gets worse. You don’t hear an oncologist say “you have cancer so let’s wait a few months to treat it”.
IMO they should have been handing out sealed packets of pills containing the HCQ+ (or the IVM+) regimen at every test site that said “break open in case of positive test” so anyone who got the bad news could start fighting it that very minute. Hell given the general safety of these they could have probably started taking them before they even got the test results. It’s only a few days worth of pills.
I read somewhere that molnupiravir (Merck’s covid pill) costs 712 dollars per course. The government has already committed to buying over a billion dollars of it, despite the fact it has not yet been approved for emergency use, let alone full approval.
Ivermectin costs about 6 cents per pill, and an average size person takes 6-8 pills per day in one course of treatment, for 5-10 days.
Also read a doctor’s comments elsewhere that the early trials of molnupiravir show it’s about half as effective as ivermectin.
#CrimesAgainstHumanity
I would love to see one damn set of full clinical trials to get the use of ivermectin approved in the treatment of COVID-19 (DELTA). However, the problem with ivermectin and other alternate treatments is it requires a tremendously expensive procedure (clinical trials) to get them approved for use. The major pharmaceuticals are not apt to finance it given the financial situation. To get the financing you will need an organized effort and that could open up the door to people taking the money to their offshore banks (like Clinton did with the Haiti relief money).
If only we had a President to push the FDA to begin clinical studies of Ivermectin funded by Operation Warp Speed while simultaneously procuring a billion doses to distribute in case the study proved effective. But those tweets!
There are several double blind, randomized control trials here: https://ivmmeta.com/
“Ivermectin proposes many potentials effects to treat a range of diseases, with its antimicrobial, antiviral, and anti-cancer properties as a wonder drug. It is highly effective against many microorganisms including some viruses. In this comprehensive systematic review, antiviral effects of ivermectin are summarized including in vitro and in vivo studies over the past 50 years. Several studies reported antiviral effects of ivermectin on RNA viruses such as Zika, dengue, yellow fever, West Nile, Hendra, Newcastle, Venezuelan equine encephalitis, chikungunya, Semliki Forest, Sindbis, Avian influenza A, Porcine Reproductive and Respiratory Syndrome, Human immunodeficiency virus type 1, and severe acute respiratory syndrome coronavirus 2. Furthermore, there are some studies showing antiviral effects of ivermectin against DNA viruses such as Equine herpes type 1, BK polyomavirus, pseudorabies, porcine circovirus 2, and bovine herpesvirus 1. Ivermectin plays a role in several biological mechanisms, therefore it could serve as a potential candidate in the treatment of a wide range of viruses including COVID-19 as well as other types of positive-sense single-stranded RNA viruses. In vivo studies of animal models revealed a broad range of antiviral effects of ivermectin, however, clinical trials are necessary to appraise the potential efficacy of ivermectin in clinical setting.” https://pubmed.ncbi.nlm.nih.gov/32533071/
Me too! I'd also like to see a full investigation into the FISA abuses. And a full investigation into the after hours ballot stuffing simultaneously in several key states after Election Day. And a full investigation into FauXi's role in the Wuhan bioweapons funding. And a full investigation into the role that the FBI played on Jan 6th. I'd like to see it. I likely won't tho'. Not under this administration. And probably not even under a Trump 2024 victory.
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