Zemirah Loc: Sojourner En Route...

Just one day after the Food and Drug Administration revived its war against COVID-19 treatment Ivermectin, disingenuously calling it a "horse dewormer," Tennessee Gov. Bill Lee signed a law allowing residents to access the treatment without a prescription.

The FDA's renewed attacks this week developed when it said the word Ivermectin was trending on the newly liberated Twitterverse under Elon Musk.

"Hold your horses, y'all. Ivermectin may be trending, but it still isn't authorized or approved to treat COVID-19," Joe Biden's agenda said.

But on Wednesday, a report from Liberty Counsel confirmed that Lee signed into law a plan making the "award-winning antiviral drug … available for the treatment of COVID-19 without a prescription."

The Tennessee State House had adopted the idea 22-6 and the Senate 66-20.

Liberty Counsel explained, "The bill states that a pharmacist can provide ivermectin to a patient, who is 18 years of age or older, 'pursuant to a valid collaborative pharmacy practice agreement containing a non-patient-specific prescriptive order and standardized procedures developed and executed by one or more authorized prescribers.'"

The organization said that means adults can explain their symptoms to a pharmacist, fill out some paperwork and the pharmacist then can provide the drug.

Liberty Counsel noted," The 2015 Nobel Prize in Physiology and Medicine was awarded to William C. Campbell and Satoshi Ömura for their discoveries leading to ivermectin. ivermectin is best known for its antiparasitic properties that can help prevent COVID-19 and is especially effective as early treatment. The drug also has antiviral and anti-inflammatory properties and studies have shown that ivermectin helps to lower the viral load by inhibiting replication. According to a June 2020 study published in the Antiviral Research Journal, a single dose of ivermectin can kill 99.8 percent of the virus within 48 hours."

It has been shown to speed recovery by inhibiting inflammation, and protect against organ damage.

"Cheap and effective drugs like ivermectin are being denied to the public while pharmaceutical companies make money from COVID shots that are neither safe nor effective. Studies and personal testimonies have repeatedly shown the effectiveness of ivermectin. The focus should always be about helping save lives rather than putting more money in the pockets of Big Pharma. All states should follow Tennessee’s lead," said LC Chairman Mat Staver.

WND had reported: "The reference to horses played on the explosion last fall of media articles and social media posts mocking people who treated COVID-19 with the drug as ignorant rubes who were sneaking into farms or patronizing Tractor Supply stores in quest of 'horse dewormer.'

"During the pandemic, Twitter and other social media platforms censored positive mention of ivermectin and hydroxychloroquine despite the countless testimonies and dozens of studies from around the world showing the drugs to be effective in treating COVID-19."

Inexplicably, the FDA lied again this week, saying, "Also, a reminder that a study showed it didn't actually work against COVID."

Squiddiddler Loc: Phoenix

Smart man this Governer

Zemirah Loc: Sojourner En Route...

If only other Governors across the country (Republicans and Democrats) will stiffen their backbones, and emulate his courageous stand, we can possibly bankrupt a few of these government officials who have heavily invested in the Pharmaceutical production of the non-effective Covid vaccines...

More importantly, we can all gain easy access to lifesaving medications when needed, and stop Covid in its tracks.

Jlw Loc: Wisconsin

I think that the FDA will approve it as soon as the money runs out for the clot shot

moldyoldy

That will get him votes from the magaverse but the FDA is in control.

Zemirah Loc: Sojourner En Route...

The FDA’s War Against the Truth on Ivermectin
David R. Henderson
Charles L. Hooper
– October 18, 2021

On July 28, 2021, 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. 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 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 warning that “you should not use ivermectin to treat or prevent Covid-19.” The FDA’s strong warning include: “serious harm,” “hospitalized,” “dangerous,” “very dangerous,” “seizures,” “coma and even death,” and “highly toxic,” although they had already approved the drug years ago as a safe and effective anti-parasitic. The FDA claimed, with no scientific basis, that ivermectin is not an antiviral, notwithstanding its proven antiviral activity.

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, with 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 to denote new uses for a drug, 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 new warning from the FDA is more correct and less alarming than the previous one.

In a statement from February, Merck, originator and seller of ivermectin, agreed with the FDA that ivermectin should not be used for Covid-19.

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

The FDA judges all drugs as guilty until proven, by FDA’s procedures, both safe and efficacious. The FDA proceeds ONLY if a deep-pocketed sponsor "justifies" their approval of a new drug, or the new use of an existing drug. For an old drug like ivermectin, long since generic, a new sponsor may not appear although the drug is effective because expenditures used to secure new use approval will help other generic manufacturers who invested nothing. Due to generic drug substitution rules at pharmacies, Merck could spend millions of dollars to add a Covid-19 label to ivermectin and get zero return. Companies will not make that investment.

Without a sponsor, there is no new use FDA-approval, and no official notice of ivermectin’s increased value. The FDA’s warning against ivermectin was not based on science, but on process. A typical bureaucrat, the FDA won’t recommend the use of ivermectin because, although it might help patients, it would violate their "processes." The FDA needs boxes checked off in the specified sequence. If a sponsor never materializes the boxes remain unchecked, and the FDA tells Americans to avoid the drug. The drug is Guilty until proven innocent.

There are two reasons that Merck would warn against ivermectin usage for Covid-19, throwing its own drug under the bus.

Once they are marketed, doctors can prescribe these safe 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.

Off-label prescribing is widespread and completely legal, however it is illegal for a pharmaceutical company to promote that new use. Doctors can use drugs for off-label uses and drug companies can supply them with product, but it is illegal for companies to support, or promote the new use off-label prescribing. The U.S. government fines for promoting are lucrative. In one recent period, the Justice Department collected over $6 billion from drug companies for off-label promotion of legal drugs. Merck’s lawyers haven’t forgotten that lesson...

Another reason Merck discounts ivermectin’s efficacy is a result of marketing strategy. Ivermectin is an old, cheap, off-patent drug. Merck will never make substantial money from ivermectin sales. Drug companies want new winners with long patent lives. Not coincidentally, Merck recently released the clinical results for a new Covid-19 fighter, molnupiravir. Analysts are predicting multi-billion-dollar sales for molnupiravir.

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 intend we 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.

David R. Henderson is a Senior Fellow with the American Institute for Economic Research, a research fellow with the Hoover Institution at Stanford University and emeritus professor of economics with the Naval Postgraduate School, and editor of The Concise Encyclopedia of Economics, and served as senior economist for health policy with President Reagan’s Council of Economic Advisers.

Charles L. Hooper is President and co-founder of Objective Insights, Inc., author of "Would the FDA Reject Itself?", his resume' includes prior positions at Merck & Co., Syntex Labs, and NASA.

moldyoldy

Enjoy it if you want to.

https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19

https://www.nejm.org/doi/full/10.1056/NEJMoa2115869

Zemirah Loc: Sojourner En Route...

moldy, This information is inadequate and outdated.

Anyone would have to be a galloping idiot or blind staggering drunk to take the dosage of Ivermectin recommended for a horse or cow...

Obviously, the body weight differs drastically.

In places Where Ivermectin is used when prescribed for human use, the Nobel Prize-winning drug, Ivermectin, has been a game-changer — not that the establishment media will ever admit it.

All the way back in April 2020, the journal Antiviral Research published an article touting ivermectin’s possible efficacy in inhibiting the virus.

Researchers looked into 31 “onchocerciasis endemic” countries using “community-directed treatment with ivermectin” and compared their COVID-19 statistics with 22 “non-endemic” countries.

The mortality rate was “significantly less” in the 31 nations with high ivermectin use.

The numbers out of Africa prompted Tokyo Medical Association chairman Haruo Ozaki to support the drug’s use in combating the seemingly endless pandemic.

Everything I've read in the last two years on the beneficial results of this drug in treating Covid-19 reports that it is most effective the sooner it can be given after the illness ensues.

However, on the government website following your link, emphasis is on randomization in testing twenty eight days into the illness, at which point you'd be near death

That seems completely counterproductive. Why bother?

moldyoldy

The dosage used for parasites in humans has been used and rejected.

AuntiE Loc: 45th Least Free State

They have already made their money; both politicians and the pharmaceutical companies.

AuntiE Loc: 45th Least Free State

Did they use the human formula? It is a simple formula;3 mg per 100 pounds for human dosage.

AuntiE Loc: 45th Least Free State

” Anyone would have to be a galloping idiot or blind staggering drunk to take the dosage of Ivermectin recommended for a horse or cow...” A more than adequate description of ________.

moldyoldy

AuntiE Loc: 45th Least Free State

I was thinking it nicely described you..though I do not think you are a galloping idiot more like trotting.

Ricktloml

Amen! Ivermectin should be available in ALL states. It is sickening that the Biden administration/big pharma are keeping this from the public.