Pharma-Controlled FDA Revokes Authorization for Monoclonal Antibody Treatments
The U.S. Food and Drug Administration (FDA) announced Monday it was halting emergency-use authorizations (EUA) for two monoclonal antibody therapies, one made by Regeneron Pharmaceuticals and one by Eli Lilly, falsely claiming the treatments are not effective against the Omicron variant.
Meanwhile, the FDA has not revoked EUA for the 2020 COVID vaccines made by Moderna, Pfizer and Johnson & Johnson (J&J), despite the fact vaccines do not prevent infection or transmission, are not effective against predominant COVID variants, have injured tens of thousands and have caused millions of breakthrough cases — at least 1,819,330 resulting in hospitalizations and 16, 727 resulting in deaths as of Nov. 2021, according to the U.S. Centers for Disease Control and Prevention (CDC).
When two doses of Moderna and Pfizer COVID vaccines didn’t work, and the one-dose J&J shot failed, additional doses were recommended. Now there is talk of a fourth dose (fifth for immunocompromised) and a modified Omicron vaccine Pfizer expects to have ready in March. In the meantime, vaccines with laughable efficacy are still being mandated for Americans and enjoy the continued benefits of emergency use authorization.
So why the sudden revocation of EUAs for effective monoclonal antibody treatments? The FDA claimed “data show these treatments are highly unlikely to be active against the omicron variant,” and because omicron is believed to account for more than 99% of current COVID cases, the treatments are no longer authorized.
The agency said it was focused on preventing side effects from treatments they do not believe work while ignoring over a million adverse events and almost 22,000 reported deaths following COVID vaccines reported to the CDC’s Vaccine Adverse Event Reporting System.
The more likely reason is that the FDA has been “captured” and monoclonal antibody treatments compete with the products of the pharmaceutical companies that have captured the FDA.
Regulatory capture occurs when agencies become controlled by the industries they are charged with regulating and begin to “operate essentially as an advocate for the industries it regulates.”
There is simply no other explanation for withdrawing authorization of a treatment that has helped millions of people while allowing EUAs for ineffective vaccines and drugs like Remdesivir to continue.
In response to the FDA’s news, centers in Florida administering the treatment had to be closed. The Florida Department of Health announced it was closing all monoclonal antibody treatment sites in the state due to the FDA’s decision.
“Unfortunately, as a result of this abrupt decision made by the federal government, all monoclonal antibody state sites will be closed until further notice,” the Florida Department of Health said in a statement.
Florida’s Gov. Ron DeSantis blasted the Biden administration for the decision.
“Without a shred of clinical data to support this action, Biden has forced trained medical professionals to choose between treating their patients or breaking the law,” DeSantis said in a statement. “This indefensible edict takes treatment out of the hands of medical professionals and will cost some Americans their lives. There are real-world implications to Biden’s medical authoritarianism — Americans’ access to treatments is now subject to the whims of a failing president.”
“Rather than giving Americans the option for various COVID treatments, the FDA and the Biden Administration issued their royal decree, taking away the very thing that is proven to reduce hospitalizations and save lives,” said Lieutenant Governor Jeanette Nuñez. “Monoclonal antibody treatments like Regeneron have had a positive impact for thousands of Floridians. For the CDC and FDA, which have been consistently inconsistent throughout the entire pandemic, to restrict treatment does nothing but put individuals at risk.”
“In our field of medicine, when someone comes to you seeking a treatment that could save their life, it is essential to have treatment options to ensure health care providers can make the best decisions for their patients,” said Surgeon General Dr. Joseph Ladapo. “The Federal Government has failed to adequately provide the United States with adequate outpatient treatment options for COVID-19. Now, they are scrambling to cover up a failure to deliver on a promise to ‘shut down the virus.’”
HHS pushed back, with a spokesperson claiming DeSantis is “more interested in promoting medicines that don’t work than urging people to take vaccines that do[.]”
Clearly, that’s what this is about. The Biden administration and U.S. health agencies, that have been captured by pharmaceutical companies, want people to get vaccinated, take the new Merck pill or Pfizer’s dangerous COVID pill. They want to wait until people are so sick they have to go to the hospital, get treated with toxic Remdesivir and put on a ventilator — all things hospitals get kickbacks from our federal government for.
White House press secretary Jen Psaki said it’s “crazy” for DeSantis to advocate for the use of monoclonal antibody treatments after the FDA’s decision to suspend.
“Well, let’s just take a step back here just to realize how crazy this is,” Psaki told reporters during a Tuesday press briefing. “These treatments — the ones that they are fighting over, that the governor’s fighting over — do not work against Omicron, and they have side effects. That is what the scientists are saying.”
This is coming from a press secretary who got COVID despite being “fully vaccinated” and boosted.
Psaki went on to attack DeSantis for being among a number of elected officials “advocating for things that don’t work” against the virus, including “injecting disinfectant, promoting other pseudoscience, sowing doubt on the effectiveness of vaccines and boosters” — claims that are categorically false.
DeSantis, who is being harassed by the media for not revealing his private medical information — whether he’s received a useless COVID booster shot — demanded the FDA reverse its decision in a statement on Monday.
“Without a shred of clinical data to support this action, Biden has forced trained medical professionals to choose between treating their patients or breaking the law,” DeSantis said. “This indefensible edict takes treatment out of the hands of medical professionals and will cost some Americans their lives. There are real-world implications to Biden’s medical authoritarianism – Americans’ access to treatments is now subject to the whims of a failing president.”