Remdesivir

Remdesivir was a strange choice to see among early treatment attempts because renal failure was a known side effect, and COVID-19 has a high mortality risk multiplier for people with renal failure.¹⁾ However, Chinese researchers claimed early to have tested it in vitro on SARS-CoV-2 with promising results.

See remdesivir for prior research and side effects profile.

According to the National Institute of Health, remdesivir has “shown to be safe for patients” and “works by interrupting production of the virus. Coronaviruses have genomes made up ribonucleic acid (RNA). Remdesivir interferes with one of the key enzymes the virus needs to replicate RNA. This prevents the virus from multiplying.”²⁾ The NIH gives no citations for these statements.

• On November 20, 2020, the World Health Organization recommended against the use of remdesivir.³⁾

• https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31022-9/fulltext?fbclid=IwAR1LTlCHCyPOEIed1jfcYeUq5CnRFtDTUkx9xAH9yMmObg0G-tGpsfB3dbw

No prospective clinical trials have been conducted through 2021 examining viral loads of patients given remdesivir. One retrospective study was published showing no difference in nasopharyngeal viral loads of hospitalized patients treated using remdesivir as compared with those who were not.⁴⁾

The summary of published research suggests that remdesivir does improve patient outcomes. The early treatment studies show dramatic reduction in hospitalization and death, though the late treatment studies show modest reduction in mortality of around 13% to 19% despite increasing the need for hospitalization by 36% and mechanical ventilation by 38%. ⁵⁾

The seven total randomized control trials testing for mortality effects of over 8,000 patients found an 8% overall reduction in mortality among patients treated with remdesivir.⁶⁾

• Jan 19, 2020: The first known U.S. COVID-19 patient was treated with remdesivir.⁷⁾
• April 15, 2020: A study on 12 total rhesus macaques is released claiming a “clear clinical benefit” in reduction of COVID-19 symptoms.⁸⁾
• June 13, 2020: The Health Ministry of India allows for the use of remdesivir under an emergency use authorization.⁹⁾
• June 25, 2020: Remdesivir becomes the first drug approved (under the name Veklury) by the European Medicines Agency for the treatment of COVID-19 through a conditional marketing authorization.¹⁰⁾
• July 10, 2020: FranceSoir notes the evolution of the lens through which remdesivir studies were evaluated, which appears like cherry-picking for significance.¹¹⁾
• August 2, 2020: Professor Didier Raoult, the first Western researcher to test the use of hydroxychloroquine on COVID-19 patients, reveals that a Gilead-funded French doctor threatened his life.¹²⁾
• August 19, 2020: China reaffirms its protocol of using chloroquine to treat COVID-19 patients, rejecting the use of remdesivir.¹³⁾
• October 12, 2020: Uganda approves remdesivir to treat COVID-19.¹⁴⁾
• October 23, 2020: The U.S. Food and Drug Administration approved remdesivir to treat hospitalized COVID-19 patients making remdesivir the very first approved FDA drug during the pandemic.¹⁵⁾
• Apr 7, 2021: Hospitals in Mumbai suffer remdesivir shortage as COVID-19 cases spike.¹⁶⁾
• Apr 28, 2021: Retired Colonel Sanjay Pande (India) complains that the U.S. is dumping expensive remdesivir on India.¹⁷⁾

You might be surprised to hear that about 20% of Gilead’s 2021 revenue came from sales of remdesivir, which enjoyed USD 5.6 billion in sales. As far as they are concerned, remdesivir is a runaway success.

In fact, the US government goes as far as to pay hospitals to use it, with a bonus in the tens of thousands of dollars per patient that uses it, called the “New Treatments Add-On Payment”. No wonder US hospitals spent over USD 1 billion on remdesivir last year, more than on any other drug.

So we are faced with the riddle of remdesivir; why is a drug that costs more than $2000 per treatment, which is associated with kidney failure, being given at a time that reason, and research, tells us it can’t have much of an effect?

The plot thickens, as it turns out the FDA knew.

The Emergency Use Authorization (EUA) of remdesivir, released via a Freedom of Information Act (FOIA) request contains an incredibly troubling paragraph;

Clinical Virology remains concerned about the disconnect regarding this drugs mechanism of action and the timing of treatment administration. Remdesivir is an analog of adenosine triphosphate that inhibits viral RNA synthesis, and as such, the drug would most likely work early in the infection cycle when SARS-CoV-2 replication is occurring at a high level. Most patients who are hospitalized with COVID-19 are entering the hospital during the second week of infection when viral loads are in decline and the underlying disease is associated with severe lung pathology driven by a hyperactive immune response and cytokine release syndrome. It is not clear that remdesivir will have much of an impact on viral replication this late into the infection cycle. ¹⁸⁾ In other words, exactly what we’ve documented in this article so far.

This paragraph was written on the 4th of May of 2020, only a few months after the official declaration of a pandemic, and almost two years ago. And yet, the vast majority of remdesivir administration was made with this observation being obvious enough that the FDA reviewers could notice it. I refuse to believe that the Gilead staff did not understand enough pharmacology not to make this incredibly obvious error. ¹⁹⁾

Report on Medicare Compliance 29, no. 39 (November 2, 2020)

CMS said Oct. 28 that Medicare will pay hospitals extra when they treat inpatients with drugs or biologicals approved by the Food and Drug Administration (FDA) for COVID-19. The additional payments are linked to the 20% bonus hospitals already receive for COVID-19 MS-DRGs, and both require proof of a positive COVID-19 test, according to the fourth interim final rule with comment period (IFC).[1] CMS also raised the specter of post-payment reviews.

The interim final rule, which implements section 3713 of the Coronavirus Aid, Relief, and Economic Security CARES Act, also said Medicare, Medicare Advantage (MA) and commercial payers must offer FDA-approved vaccines free to patients. Medicare and MA will pay hospitals, physicians, pharmacists and others a fee for the administration of the vaccine and a fee for the vaccine itself.

The ball for the newest add-on payments got rolling with the advent of coronavirus therapies. As the regulation explains, the FDA created a program for possible coronavirus therapies called the Coronavirus Treatment Acceleration Program, which includes issuing emergency use authorizations (EUAs) during the PHE. The FDA has issued EUAs for five drugs and biologicals for COVID-19, although only remdesivir and COVID-19 convalescent plasma are eligible for the add-on payment in connection with the inpatient prospective payment system (IPPS). ²⁰⁾

Today, the U.S. Food and Drug Administration took two actions to expand the use of the antiviral drug Veklury (remdesivir) to certain non-hospitalized adults and pediatric patients for the treatment of mild-to-moderate COVID-19 disease. This provides another treatment option to reduce the risk of hospitalization in high-risk patients. Previously, the use of Veklury was limited to patients requiring hospitalization.

“On the heels of the FDA’s recent authorization of two oral antiviral drugs, today’s actions bolster the arsenal of therapeutics to treat COVID-19 and respond to the surge of the omicron variant,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Today’s actions provide adults and pediatric patients, with mild-to-moderate COVID-19 who are at high risk of severe COVID-19, with a treatment option they could receive outside of a traditional inpatient hospital setting, including at skilled nursing facilities, home healthcare settings and outpatient facilities such as infusion centers.” ²¹⁾

see also FORBES - The Strange Story Of Remdesivir, A Covid Drug That Doesn’t Work²²⁾

Donald Trump was treated with remdesivir in the way that reason dictates: as soon as possible. Peter Hotez commented, matter-of-factly-

Thread on POTUS therapies; Being asked about mab cocktail from Regeneron and remdesivir and what it means?

'I think a key point is that use of antiviral drugs, if they are to be effective likely must be administered early in the course of the illness during viral replication.'²³⁾²⁴⁾

And yet almost everyone else got the drug when it was already too late for it to help.

Dr. Anthony Fauci speaks on the clinical trial for potential coronavirus treatment drug remdesivir;

“What it has proven is that a drug can block this virus … This drug happens to be blocking an enzyme that the virus uses.“ ^25)26)27)

As a side note, besides Fauci, a cast of characters well known among those who have been investigating the lab leak hypothesis make their appearance. Peter Daszak was sure to claim credit for assisting in the development of remdesivir. (60 minutes) ²⁸⁾ “The breakthrough drug Remdesivir that seems to have some impact on COVID-19, was actually tested against the viruses we discovered under our NIH research,” says disesase ecologist Peter Daszak, whose coronavirus research grant was just cut by the NIH” ²⁹⁾

But the real hero in the development of remdesivir is Mr. Gain-of-function himself, Ralph Baric. What was his role? Allow him to explain..

“It's a game changer,” says Dr. Ralph Baric, an epidemiologist about data that suggests the experimental drug remdesivir might help patients recover more quickly from the infection.

“It offers real hope to humans infected with this terrible virus.” ³⁰⁾³¹⁾

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