'Normalization' Of Emergency Use Authorizations Concerns Health Experts
'Normalization' Of Emergency Use Authorizations Concerns Health Experts | ZeroHedge
More Emergency Declarations and EUAs Likely To Come
Health experts argue that COVID-19 pandemic management has already lowered the standards for future emergency declarations and EUAs.
Dr. Robert Malone, biochemist and one of the inventors of the mRNA drug platform, said that monkeypox, which was declared a public health emergency in August 2022 with no deaths in the U.S. at the time, is a good example of this reduced standard.
Given that the disease almost exclusively affects men who have sex with men, a specific population demographic, and has led to
20 deaths in the United States thus far, Bell and Wastila both said that it was ludicrous that it was deemed a public health emergency.
“Now the cat’s out the bag, [public health emergency declarations] can be used really easily now because there are precedents [such as] COVID-19 and monkeypox that were not very severe,” Bell said.
The smallpox vaccine, commercially labeled as JYNNEOS, was also rapidly given EUA approval in a matter of days.
The FDA wrote that it
was “inferred” that a smallpox vaccine would be effective against monkeypox, given that both viruses are from the same family.
However, according to
a statement made by the CDC on Oct. 19, 2022, there was no data on the effectiveness of JYNNEOS or ACAM2000, an alternative to JYNNEOS, for monkeypox.
A sign announcing monkeypox vaccination is set up in Tropical Park by Miami-Dade County and Nomi Health in Miami, Fla., on Aug. 15, 2022. (Joe Raedle/Getty Images)
The vaccine also has cardiological side effects.
Pooled data across 22 studies showed that of the more than 7,800 people vaccinated, six developed cardiac-related adverse events that were determined to be causally related to vaccination.
Concerns have been raised about the respiratory syncytial virus, known as RSV, in children. Though the virus has not been declared a national public health emergency, declarations have been made in Oregon and Colorado, and some health experts have urged a national declaration.
“We’ve had RSV and the flu every year, and all of a sudden, it’s become a big issue again, and it’s because we’re afraid of every viral infection, [we’re] normalizing being fearful of every contagion,” said Wastila.
Loss of Trust in Public Health
As a pharmacotherapy professor who is in contact with pharmacists and staff working with the FDA, Wastila confessed that the pandemic has been a “rude awakening” for her.
“Physicians, dispensers, and pharmacists just blindly follow the safety and effectiveness of a product just because it has the FDA seal of approval, even if that ‘approval’ is an EUA.”
Though financial backdoor dealings have been suspected and discussed for decades, Malone argues that the pandemic has brought “corruption” to the surface.
Financially, 65 percent of the FDA’s budget comes from pharmaceutical companies, with a large proportion of this money coming through sponsorship for drug approval applications.