(Times Of Israel) In an “exceptional” emergency move, the FDA has greenlighted Remdesivir, an untested, experimental, and extremely expensive drug developed for the treatment of Ebola, to now be given to all hospitalized patients with advanced COVID-19 lung infections:
The results of US trials of antiviral drug remdesivir for treating coronavirus are encouraging, but it is too early to celebrate, the CEO of the drugmaker’s Israel branch said in an interview Monday.
The drug last week received fast-track FDA approval for emergency use in treating COVID-19.
“Initial results are encouraging, but it is important to note that the measure taken by the Food and Drug Administration was exceptional. It approved the emergency use of the drug to respond to the global pandemic which is an extraordinary situation,” Ofra Feinmesser of Gilead Sciences Israel told the Ynet news website.
“The drug is still in the trial stage, but has been authorized for emergency use, which means that in the United States it will be used as a treatment for hospitalized patients. The drug is still a trial drug, which means that we are continuing to study it in order to gather data to prove its safety and efficacy.”
…Remdesivir is a broad-spectrum antiviral medication originally developed for the treatment of Ebola.
Last Friday, the FDA cleared Gilead Sciences’ intravenous drug for hospitalized patients with “severe disease,” such as those experiencing breathing problems requiring supplemental oxygen or ventilators.
“This was lightning speed in terms of getting something approved,” said FDA commissioner Stephen Hahn, calling the drug “an important clinical advance.”
The FDA acted after preliminary results from a government-sponsored study showed that remdesivir shortened the time to recovery by 31 percent, or about four days on average, for hospitalized COVID-19 patients.
Those given the drug were able to leave the hospital in 11 days on average vs. 15 days for the comparison group. The drug may also help avert deaths, but the effect on mortality rates, if it exists, is not yet clear…
The FDA said preliminary results from the government study warranted Friday’s decision, though regulators acknowledged “there is limited information known about the safety and effectiveness of using remdesivir.”
The drug’s side effects include potential inflammation of the liver and problems related to its infusion, which could lead to nausea, vomiting, sweating and low blood pressure. Information about dosing and potential safety issues will be provided to physicians and patients, the FDA said.
The National Institutes of Health’s Dr. Anthony Fauci said last Wednesday the drug would become a new standard of care for severely ill COVID-19 patients. Remdesivir, which blocks an enzyme the virus uses to copy its genetic material, has not been tested on people with milder illness.
The FDA authorized the drug under its emergency powers to quickly speed the availability of experimental drugs, tests and other medical products during public health crises.
In normal times the FDA requires “substantial evidence” of a drug’s safety and effectiveness, usually through one or more large, rigorously controlled patient studies. But during public health emergencies the agency can waive those standards and require only that an experimental treatment’s potential benefits outweigh its risks.
Gilead has said it will donate its currently available stock of the drug and is ramping up production to make more. It said the US government would coordinate distribution of remdesivir to parts of the country that need it most.
What Fauci stated about Remdesivir becoming “standard of care” for COVID-19 amounts to a potentially huge financial windfall for Gilead-Israel.
Remdesivir costs about $1,000 per dose — whereas hydroxychloroquine, which does work, costs only $0.65 per dose.
“Standard of Care” in medical parlance means that this drug will be used on every patient in hospitals with advanced COVID-19-related breathing problems.
The “Standard of Care” designation is what every drug company aspires toward with any drug — and without proper testing of its effectiveness or safety, Fauci has already tentatively granted Remdesivir that coveted status.
Only an ‘antisemite’ would question the sagacity or motivation of such an unprecedented move by the FDA in favor of this insufficiently-tested Israeli-produced drug.
After all, only a couple of weeks ago the FDA greenlighted another questionable Israeli drug — one used to treat erectile dysfunction — to treat COVID-19.
But recall how the FDA dragged its feet over even allowing the cheap, safe and effective hydroychloroquine to be tested on COVID-19 patients — despite overwhelming anecdotal evidence that it was actually curing many patients, not merely reducing their hospital stays by four days, as is the case with the expensive Remdesivir.
We reported in November of 2019 — just a few months prior to the “COVID pandemic” outbreak — that the FDA announced it was opening a satellite office in Tel Aviv to help fast-track Israeli drugs to the U.S. market.
But let’s not jump to any ‘antisemitic’ conclusions.
Any ‘exceptional’ or ‘unprecedented’ or preferential treatment Israeli drug companies receive from the FDA, of course, “must be” well-deserved.
Chesterton
A doctor now admits that this Israeli drug, Remdesvir, has no impact on the viral load of an infected patient, and that this drug is “probably worthless” to treat COVID-19.
https://www.zerohedge.com/health/remdesivir-probably-worthless-trauma-surgeon-exposes-drug-companys-shenanigans
Stevie
I still have not met nor do I know a single person in my life that contracted this “virus.” Anything that comes out of that criminal state called Israel is not good for the goyim. Any medication coming out of Israel will be for profits only and not a cure. Israel isn’t going to cure the goyim, whom they’ve been killing off in recent years.
I Dunno
THE LEFT’S HATRED FOR SCIENCE
[excerpt]
Eugenicist thinking was revived by scientists convinced that the human species had exceeded the “carrying capacity” of its ecosystem. The most prominent was Paul Ehrlich, whose scientific specialty was the study of butterflies. Undeterred by his ignorance of agriculture and economics, he published confident predictions of imminent global famine in The Population Bomb (1968). Agricultural economists dismissed his ideas, but the press reverently quoted Ehrlich and other academics who claimed to have scientifically determined that the Earth was “overpopulated.” In the journal Science, ecologist Garrett Hardin argued that “freedom to breed will bring ruin to all.” Ehrlich, who, at one point, advocated supplying American helicopters and doctors to a proposed program of compulsory sterilization in India, joined with physicist John Holdren in arguing that the U.S. Constitution would permit population control, including limits on family size and forced abortions. Ehrlich and Holdren calmly analyzed the merits of various technologies, such as adding sterilants to public drinking water, and called for a “planetary regime” to control population and natural resources around the world.
https://www.city-journal.org/html/real-war-science-14782.html
Chesterton
Paul Ehrlich, of course, is Jewish, and even though none of his dire predictions ever came true, he’s still held up as some kind of prophet or ‘expert’ on population. As a Jew, he tried to remove race from the equation–and falsely claimed that White people were also contributing to the over population problem, which is ridiculous. Unlike other races, Whites have always been able to produce enough food to support their expanding populations (aside from times of natural disasters). No other race has had to come to our rescue, but even the so-smart Jews have needed us to bail them out one way or another…..
Lisette
“even the so-smart Jews have needed us to bail them out one way or another”……this is a statement of fact. Now, if you pay attention to what’s going on in white countries you come to the conclusion that Jews of something on white people. Jews foment hatred against white people every step of the way but white people continue to bail them out and at their own peril. Which means that white people have a serious problem or are in one way or another and for a lot of reasons hopelessly addicted to the so-smart Jews. The history of Europe and America tells the story loud and clear. Question is who’s going to break the addiction?
westwins
“……..Which means that white people have a serious problem …….”
Indeed……………….it’s called Sin and the rejection of their Heavenly Father.
Jesus said the road was narrow and only a few will Strive to enter and receive Eternal Glory.
The ONLY explanation for the Jewish Question is the Word of our Father. No other explanation suffice. Jacob Vs. Esau. Very simple.
“The fear of the LORD is the beginning of wisdom, and knowledge of the Holy One is understanding.” Proverbs 9:10
luke2236
Yep, and add “My people are destroyed for lack of knowledge…”
Lisette
Religion is at the heart of the matter but I am not so sure if that is the only thing. Through edicts Spanish and Portuguese monarchs created a ‘social category’ aka ‘New Christians’ to refer to and deal with Jews and the Muslim Moors who converted whether willfully or forcefully to Roman Catholicism. Then came Martin Luther who rejected some teachings and practices of the Roman Catholic Church which gave birth to movement against the errors in the Catholic Church aka Protestantism. The genesis of the schism between Europeans.
It became a perfect recipe for the middle man aka New Christian to play both sides and successfully pit them against each other too. I can’t remember how many times I’ve heard people who claim to be Christian say Catholics are evil, they are not Christian, while they support Jewish supremacist who foment hatred against Christians and white people……
Ottify
Answer: Christ.
Lisette
I am not a religious fanatic but there is something in Christianity that tames the beast within, something that Judaism does not have. When I talk about it people look at me like I am cookoo…..but its right there if you read between the lines. Without the Spirit of Christ there would be no western civilization.