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COVID-19

FDA Panel Recommends Merck Covid Pill, Despite ‘More Questions Than Answers’

The U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee on Tuesday voted narrowly, 13 to 10, to recommend Emergency Use Authorization (EUA) of Merck’s five-day pill to treat COVID.

The drug, molnupiravir, sold under the brand name Lagevrio and developed with Ridgeback Biotherapeutics, is an antiviral medication that inhibits the replication of certain RNA viruses, including SARS CoV-2.

Potential patients would take an 800-milligram pill every 12 hours for five days after COVID symptoms begin. The FDA and Centers for Disease Control and Prevention must both sign off before the drug is granted EUA and made available to the public.

The FDA panel “recommended Merck’s treatment be authorized for people with COVID who are at high risk of becoming severely ill. That would most likely cover tens of millions of Americans who are older or have medical conditions such as obesity, diabetes or heart disease,” The New York Times reported.

Molnupiravir was given in clinical trials to people allegedly infected with the variants Delta, Mu and Gamma, according to The Times. Dr. Nicholas Kartsonis, a Merck executive, said that with the newly discovered variant, Omicron, “we expect based on what we know … that molnupiravir would be effective.”

Just a few days prior to the vote, study data was released showing the effectiveness of the treatment declining from earlier data. According to The Hill:

“The drug manufacturer filed for an Emergency Use Authorization last month after its study suggested molnupiravir reduced the risk of hospitalization by 50%. But updated data from Friday showed a 30% reduction in hospitalizations among more participants.”

The federal government in June signed a $1.2 billion contract with Merck while the experimental treatment was still in clinical trials, according to ABC News. That contract was to purchase treatments for 1.7 million people. But the government has since increased that contract, agreeing to purchase “3.1 million courses of the drug, with the option to purchase more,” The Hill reported.

Freedom Phone 3

“We are witnessing another FDA charade, as its Pharma-connected advisory committee members narrowly voted to authorize molnupiravir.

“Plucked from the antiviral boneyard, molnupiravir went through a series of transfers that magically converted it from a failed drug developed at taxpayer expense to a blockbuster drug for Merck and its partner, Ridgeback.”

Molnupiravir reduced hospitalizations by only 30%, is clearly less useful than monoclonal antibodies and works “nowhere near as well as multiple other drugs for COVID,” Nass said.

Nass said molnupiravir’s mechanism of action is inducing mutations — in viruses, but “maybe in us too, as postulated by several FDA committee members.”

“It’s simply another dangerous drug that will help the federal health agencies look like they are doing something, while doing nothing to curtail the pandemic,” Nass said. “And because it is being authorized, instead of being licensed, anyone injured by the drug cannot sue for damages and is unlikely to collect any benefits.”

Mary Holland, CHD president and general counsel, told The Defender:

“There are many problems with Merck’s new cash cow — Merck doesn’t know if it will drive new mutant variants; Merck hasn’t tested the drug on vaccinated people, who will get it; and the drugmaker doesn’t know if it will be effective against new variants.

“The biggest problem, though, is the continued governmental, medical and media suppression of existing, off-patent drugs, including ivermectin and hydroxychloroquine. These products are known to be safe, effective, affordable and available. Authorizing Merck’s new bonanza while suppressing safer, more effective, less expensive alternatives points up the abject failure of the FDA to protect public health.”

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This article has been archived by Conspiracy Resource for your research. The original version from Based Underground can be found here.