by Brian Shilhavy
Editor, Health Impact News
It was announced today that the FDA has now fully approved remdesivir (now called “VEKLURY” which already has a registered trademark, something that takes years to obtain generally) as a treatment for COVID.
The path of getting remdesivir approved for use is one littered with corruption, and a process that has probably caused millions of deaths worldwide. See our previous coverage:
Was a False Hydroxychloroquine Narrative Created to Destroy the Competition for Gilead’s Remdesivir?
Editors of The Lancet and the New England Journal of Medicine: Pharmaceutical Companies are so Financially Powerful They Pressure us to Accept Papers
One of the interesting side shows to watch during COVID is Big Pharma fighting each other as they compete for a bigger slice of the pie in COVID Government funding which is currently around 6-7 TRILLION dollars.
We saw this earlier during the plandemic as many companies rushed to get COVID tests into the market. There are currently over 100 COVID tests that have been fast-tracked by the FDA, and these companies have attacked each other regarding the validity of their tests to the point where the CEO of one Big Pharma firm stated about one of his competitor’s tests:
So with remdesivir being the first COVID treatment receiving full approval by the FDA today, as opposed to merely “fast track” approval for emergency use, others in the Pharmaceutical Industry who are also rushing to get COVID drugs to market were quick to point out the lack of science backing up any evidence of effectiveness of remdesivir.
Eric Sagonowsky, reporting for the Pharmaceutical trade publication Fierce Pharma wrote:
As new COVID-19 cases spike in the U.S., and ahead of an expected winter surge, the FDA just issued its first full approval for a drug to treat the disease—Gilead Sciences’ Veklury, formerly known as remdesivir. But the approval closely follows a large trial that showed no benefit for the therapy, and experts quickly questioned the FDA’s move.
Veklury won approval to treat COVID-19 requiring hospitalization in adults and children 12 and older. Simultaneously, the FDA issued a new emergency use authorization for certain patients under 12. The agency approved the med based on late-stage trials showing Veklury is associated with an improved time to recovery and reduced disease progression in hospitalized patients, Gilead said.
Just last week, though, a large trial from the World Health Organization (WHO) cast doubts on the med’s efficacy. WHO released preliminary results from a trial of 11,266 COVID-19 patients in 30 countries on one of four drug regimens, including Veklury. The medicine “appeared to have little or no effect on hospitalized COVID-19,” the researchers wrote in a study posted (PDF) on the journal preprint site medRxiv.
Weighing in on the approval, two prominent doctors said the data don’t yet support the FDA’s decision. The green light was “astonishing,” Peter Bach, director of Memorial Sloan Kettering’s Center for Health Policy and Outcomes, wrote on Twitter.
“Of the three included studies, one lacked control, two lacked blinding, all three lacked inclusion of current standard of care,” he wrote. The results were mixed, he pointed out, and a randomized study larger than the three touted by the FDA combined was “entirely negative.”
For his part, Eric Topol, M.D., director of the Scripps Research Translational Institute, wondered how the drug could get a full approval based on the “mixed data.” It’s unclear whether the med works early or late, and there’s still much “unresolved,” Topol wrote. (Full article.)
Remdesivir, of course, was one of two experimental drugs that President Trump allegedly took that led to his “miraculous” cure from COVID, causing its stock to soar just when sales had slowed down. See: