FDA Approved Remdesivir for 28 day old babies.

What you need to know about this drug.

Remdesivir is an IV drug.  Therefore, for the past 2 years it was almost exclusively used in hospitalized patients, not outpatients.

While the profits go to Gilead, royalties go the the NIAID (Tony Fauci’s agency), Ralph Baric and the US Army, which assisted with its development. I originally omitted the fact (appreciate the reminder) that Ralph Baric, UNC professor and the US' premier coronavirus scientist, is not only a creator of ACE-2 humanized mice and chimeric SARS coronaviruses.  He is also an inventor of remdesivir and worked with the Moderna COVID vaccine beginning in December 2019 along with NIAID, even before anyone knew there would be a pandemic.   Well, maybe someone knew.

Nearly everyone who is hospitalized in the US with COVID receives remdesivir, because:

a) hospitals get a financial bonus from the government for using it, and

b) it is the top treatment recommended by the NIH Guidelines. 

The NIH Guidelines were created by a group that originally had 16 members with current or past financial ties to Gilead.  The members of the guidelines group were handpicked by the 3 co-chairs. Clifford Lane, one of the co-chairs, is a Fauci deputy. 

NIH did not issue treatment guidelines before the pandemic. It was never their job. CDC did that. I infer that Tony F. felt he couldn’t leave this task to the agency charged with it, and decided to create Guidelines and make them an NIH ‘thing’ under his wing. The reason I think so is because Tony controlled the remdesivir clinical trial, and twice changed its endpoint, which is how the drug got its EUA. Had Tony not done that, and announced its victory in the Oval Office, remdesivir would still be sitting on a shelf in some warehouse gathering dust.

Remdesivir received an early EUA (May 1, 2020) and then a very early license (October 22, 2020) despite a paucity of evidence that it actually was helpful in the hospital setting.  A variety of problems can arise secondary its use, including liver inflammation, renal insufficiency and renal failure.  Here is a list of articles revealing its kidney toxicity:

https://pubmed.ncbi.nlm.nih.gov/33340409/

WHO recommended against the drug on November 20, 2020.  

Few if any other countries used it for COVID apart from the US.  A large European trial in adults found no benefit.  The investigators felt 3 deaths were due to remdesivir (0.7% of subjects who received it.)

https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(21)00485-0/fulltext

However, on April 22, 2022 the WHO recommended the drug for a new use: early outpatient therapy in patients at high risk of a poor COVID outcome:

https://www.who.int/news-room/feature-stories/detail/who-recommends-against-the-use-of-remdesivir-in-covid-19-patients

FDA followed the WHO 3 days later by extending the remdesivir license, so the drug could be used in children as young as 28 days.

Monoclonal antibodies are only effective at the beginning of illness, as they fight the virus.  After about ten days, there is no more replicating virus and then a later phase of the disease occurs, due to an overactive immune response.  Antiviral drugs do not work during the second stage, but immune modulators do. Steroids and ivermectin are effective therapies at this stage.

Outpatient infusion centers were established to provide monoclonal antibodies to patients at the start of COVID for those who were at high risk of a bad outcome.  But now the centers are shuttered, as none of the available monoclonals work against current COVID variants.  But outpatient infusions will now be available for remdesivir, which is an antiviral drug, as a replacement.

So a new way to use remdesivir has been developed:  early, when it might actually work.  WHO says it does.  Was WHO bought off or will it actually have a positive impact?  Who knows yet?

The vast majority of COVID patients are not hospitalized until they are in the second stage of illness, which is when remdesivir, HCQ and other antivirals are not effective, since there is no more live virus.  (HCQ has some immunomodulatory actions which may explain its mild benefit at this late stage.)

The US government, which has made a series of ineffective and harmful recommendations regarding the response to COVID, has just added another harmful recommendation to the list.

The FDA just licensed Remdesivir for babies weighing 3 kg (6.6 lbs) and up. Both hospitalized children and outpatients, who are expected to be at high risk may receive it.  The drug might work in outpatients, but the vast majority of children have a very low risk of dying from COVID. If 7 deaths per thousand result from the drug, as the European investigators thought in the Lancet study of adults cited above, it is possible it will harm or kill more children than it saves.

It is also possible that since the drug is now licensed for children, virtually every child who tests positive on a COVID swab in hospital could receive it, the way adults often do. Nervous parents might even demand it for low risk children.

Shouldn’t the FDA have waited longer to see what early outpatient treatment did for older ages?  Or studied a much larger group of children? Very little has been published on the effects of remdesivir in children.  FDA provided very little information about the approval.

When we look at the press release issued by Gilead, we learn the approval was based on one open label, single arm trial in 53 children, 3 of whom died. In other words, 6% of the children died.  72% had an adverse event, and 21% had a serious adverse event. 

I heard that some nurses refer to the drug as "Run, death is near."  

Based on the paucity of information FDA released with its Remdesivir approval, it appears that FDA knows very little about the drug’s benefit in children, and our children will be the guinea pigs.  Yet again. If we let them.