It is a travesty that pharmaceutical giant Gilead’s drug remdesivir (brand name VEKLURY®) ended up on the COVID-19 inpatient treatment protocol when a previous trial for Ebola revealed alarming toxicity and death rates, and the COVID-19 trial showed no statistically significant improvement in mortality, just a reduction in the median hospital stay -- a trial endpoint selected only after no improvement in mortality was observed. 

Robert F. Kennedy Jr.’s book “The Real Anthony Fauci” explains that Fauci as head of NIAID and supervising the Gilead trials was already too invested in remdesivir to stop.  It suggests that the hospital stay endpoint was favorably tainted by discharging the treatment group early (twice as many of this group had to be readmitted).  Critical care physician Dr. Paul Marik insists that due to toxicity problems, Gilead “cooked” the first COVID-19 study leading to FDA authorization.

Early in the pandemic, President Trump, trusting Fauci’s recommendations, heaped lavish praise on Gilead and remdesivir.  When Trump was hospitalized with COVID, he received a cocktail which included remdesivir and was discharged after three days.  Ten days later, a large WHO study came out claiming remdesivir was ineffective for COVID, and the MSM collectively mocked Trump for touting it.  Well, remdesivir still has FDA approval and is on NIH’s protocol, but I don’t see the MSM mocking Joe Biden or challenging the public health agencies; maybe they’re too busy suppressing the evidence of inefficacy they themselves cited earlier.

It’s one thing for the hoi polloi being forced to take remdesivir, but who made that decision for POTUS?  Consider this timeline (pieced together from numerous sources):

• October 28, 2018: Remdesivir and 3 other drugs are entered in a clinical trial for Ebola in Africa funded by NIAID.
• August 9, 2019: Remdesivir pulled from the Ebola trial after an astonishing 53% mortality rate (the highest of the 4 drugs), with kidney failure and other lethal side effects observed.
• December 12, 2019: The New England Journal of Medicine publishes the results of the Ebola trial.
• January 31, 2020: NEJM reports on the rapid recovery of the first confirmed COVID-19 case in the U.S. being treated with, among other things, remdesivir.
• February 25, 2020: NIAID announces beginning of clinical trial of remdesivir for COVID-19.
• April 29, 2020 (online; May 16, 2020 print): The Lancet publishes a randomized, double-blind, placebo-controlled, multi-center, peer-reviewed study from China on a 10-day infusion of remdesivir for COVID-19, finding it ineffective for mortality reduction or time to recovery, with the study stopped early due to 12% serious side effects for the treatment group compared to 5% for placebo.  Data made available for analysis.
• April 29, 2020: Fauci announces at the White House that due to the improvement in median time to recovery (11 days for the treatment group vs. 15 days for the placebo group), he is unblinding and ending the NIAID/Gilead study, giving remdesivir to the placebo group and making remdesivir the COVID “standard of care.”
• May 1, 2020: FDA grants Emergency Use Authorization for remdesivir for inpatients with severe coronavirus who need extra oxygen or mechanical ventilation.
• May 22, 2020 (prelim; October 8, 2020 final): NEJM publishes NIAID/Gilead report on remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days) vs. placebo (for 10 days) for COVID-19, with mortality improvement replaced by time to recovery of 11 (prelim; 10, final) days for the treatment group vs. 15 days for placebo.  Serious adverse events were reported as high for both groups (24.6% for remdesivir, 31.6% for placebo).
• May 27, 2020: NEJM publishes a Gilead-sponsored study showing no real difference between 5-day and 10-day remdesivir for COVID-19 for the given criteria.
• June 30, 2020: Based on Fauci’s enthusiastic endorsement, the U.S. buys up the entire world stock of remdesivir.
• August 21, 2020: JAMA publishes a Gilead-sponsored study showing 5-day remdesivir superior to 10-day remdesivir for COVID-19 for the given criteria. 
• Late August, 2020: The WHO notes “a disproportionately high number of reports of liver and kidney problems in patients receiving remdesivir compared to patients receiving other drugs for COVID-19.”
• August 28, 2020: FDA extends the EUA for remdesivir to all patients hospitalized with COVID-19 regardless of severity.
• October 2, 2020: European Medicines Agency launches safety review of remdesivir due to reports of kidney problems.
• October 2, 2020: Trump is admitted to Walter Reed National Military Medical Center in the afternoon for COVID-19.  He is given an experimental monoclonal antibody therapy.   By late afternoon, Trump has also taken zinc, vitamin D, heartburn drug famotidine, melatonin and his first daily aspirin.  In the evening, Trump receives his first infusion of a 5-day course of remdesivir.
• October 3, 2020: After his oxygen level transiently dips, Trump starts dexamethasone, in addition to supplemental oxygen begun earlier.
• October 4, 2020: Trump temporarily leaves the hospital to wave to supporters.
• October 5, 2020: Trump is discharged and returns to the White House, where he continues to receive remdesivir and dexamethasone.
• October 8, 2020: Trump announces he’s no longer contagious and has stopped taking most therapeutics.
• October 8, 2020: European Union contracts with Gilead to purchase remdesivir in a deal potentially worth more than $1 billion.
• October 15, 2020 (preprint; October 19, 2020 prelim, NEJM; December 2, 2020 final, NEJM): The WHO publishes the results of a very large multi-country COVID-19 study on remdesivir, 3 other drugs and no drug, finding no benefit at all from any of the drugs on mortality and hospital length of stay.  (Side effects not reported.) 
• October 22, 2020: FDA gives approval to remdesivir for COVID-19.
• October 28, 2020:    Science Magazine publishes an indicting article on the “very, very bad look” of how remdesivir gained FDA approval.
• December 19, 2020: Clinical Pharmacology & Therapeutics publishes an article analyzing the WHO safety database revealing a 20-fold increased risk of acute renal failure with remdesivir as compared to 3 other drugs (including hydroxychloroquine) for COVID-19.
• July 15, 2021: A JAMA study on remdesivir administered to veterans shows no reduction in hospital length of stay.

To recap, on Oct. 2, 2020, Trump as a COVID inpatient began a 5-day course of remdesivir.  But the timeline of publicly available info before Trump was hospitalized, and possibly the WHO study (whose results were released to Gilead in late September, so Fauci no doubt knew) about to be published, is loaded with negative news about remdesivir (not to mention suspicious behavior by Fauci; see the two April 29, 2020 entries).  The only positive news was from the NIAID/Gilead May 22 report not subject to the usual levels of peer review and scrutiny, even then offering at best a decreased length of stay.  While decreased length of stay has value in terms of reduced suffering and hospital costs, I don’t know about you, but I’d rather suffer with the disease a few more days than take on unnecessary and not insignificant risk of organ failure and death.

Why didn’t Trump’s doctors come to the same conclusion?  I have not seen anyone ask this.  Whether it was woeful ignorance, Trump’s previous commitment to remdesivir, blind faith in Fauci, or medical establishment pressure to follow the EUA, it looks like they needlessly risked his life.

The FDA recently expanded its approval of remdesivir for COVID-19 to those with kidney problems (!) despite the phase 3 study revealing a significantly higher rate of serious adverse events.  The trail of death and destruction already left by remdesivir is heartbreaking.  If Trump wins in 2024, maybe he can make things right going forward by getting remdesivir pulled from the COVID protocol.  It won’t be soon enough.

W. A. Eliot is a pseudonym.

Image: Pixabay / Pixabay License