Coronavirus: Thread

grarpamp grarpamp at gmail.com
Thu Oct 21 00:54:01 PDT 2021


> ivermectin
>
> https://c19early.com/
> https://covid19criticalcare.com/
> https://flccc.net/
> https://c19adoption.com/
> https://ivmmeta.com/
> https://c19ivermectin.com/
> https://ivmstatus.com/
> https://hcqmeta.com/
> https://c19hcq.com/
> https://c19vitamind.com/
> https://vitamindforall.org/
> https://vdmeta.com/
> https://c19zinc.com/
> https://americasfrontlinedoctors.org/


The FDA's War Against The Truth On Ivermectin

https://www.aier.org/article/the-fdas-war-against-the-truth-on-ivermectin/

https://www.wsj.com/articles/fda-ivermectin-covid-19-coronavirus-masks-anti-science-11627482393
https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19
https://www.merck.com/news/merck-statement-on-ivermectin-use-during-the-covid-19-pandemic/
https://www.fiercepharma.com/pharma/merck-molnupiravir-blockbuster-covid-19-pandemic-endemic-oral-antivirals-market

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studies we referenced was retracted the day our article was published.
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.”

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.

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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