Pure Evil: Yesterday, the FDA approved Remdesivir, known by brand name Veklury, to include infants and children 28 days and older weighing at least 7 pounds as a Covid-19 treatment. #wtf

The FDA expanded its approval of Remdesivir, known as Veklury, yesterday, April 25th to include infants and children 28 days and older and weighing at least 7 pounds. 

The FDA had approved Gilead Sciences' Remdesivir in all hospitalized covid-19 patients age 12 and older back in October 2020. This past January the FDA authorized the use of Remdesivir in nonhospitalized patients with mild to moderate covid-19 (based on the faulty PCR test). 

"As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for this population," said Patrizia Cavazzoni, MD, director of the FDA's Center for Drug Evaluation and Research. "Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need."

Problem #1: Remdesivir Is Based on Junk Science

Dr. Pierre Kory, MD, MPA:

Remdesivir claimed the top spot for hospital drug spending in 2021, with sales earning Gilead $4.2 billion in the first nine months alone. The problem is that, at best, the drug doesn’t work.

Despite some initial indication that Remdesivir might slightly reduce recovery time, the World Health Organization conducted a large-scale analysis that found it “had little or no effect on hospitalized patients with Covid-19, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay.” Unsurprisingly, the WHO recommended against using this drug to treat Covid-19 in November 2020 (and still does).

At worst, however, Remdesivir is harmful. A subsequent analysis of the agency’s safety database found it likely caused kidney failure, and when independent trials (those not sponsored by a pharmaceutical company) are analyzed alone, there is a clear statistical trend to harm. WHO also warns that the drug may be associated with an increased reporting of liver problems.

How is it possible that an ineffective and potentially dangerous drug that is scarcely used throughout the world received more money from U.S. hospitals than any other drug?

The answer is because our drug approval system is broken. It’s skewed towards expensive, patented, often marginally beneficial or unknowingly dangerous treatments produced by our pharmaceutical industry to the detriment of well-known, safe, cheap, generic drugs – and ultimately patients.

Look at this chart created by an independent researcher that displays the efficacy of all drugs and compounds that have been studied against Covid-19. The ones circled in red are the only medicines that have received FDA Emergency Use Authorization (EUA is essentially fast-track approval) in the U.S. Each authorized medicine commands an exorbitant price while all the low-cost, effective drugs remain unauthorized for treatment of Covid-19. It would be an astonishing coincidence if the price tags were unrelated to their FDA status.

Moreover, Remdesivir was approved based on a single, small trial with questionable results. This should never be the basis for approving a medicine for mass use – even during a public health emergency. The same thing has happened with monoclonal antibodies, Pfizer and Merck’s antiviral pills, and, of course, the Covid-19 vaccines.

Even more troubling are reports that the FDA did not consult the Antimicrobial Drugs Advisory Committee in granting Remdesivir’s EUA. But the committee consists of outside experts that the FDA has at the ready precisely to weigh in on antiviral drug issues. It boggles the mind that the agency would authorize a drug without even consulting the very body that is supposed to advise it on such issues.

Compare these lightning-fast and flimsy approvals to the non-existent government response to mounting data that fluvoxamine is effective against Covid-19. The Journal of the American Medical Association and the Lancet have each published large, randomized trials to this effect, with the latter showing fluvoxamine reduced Covid-19 hospitalizations by two-thirds and deaths by over 90 percent.

The NIH review of the fluvoxamine studies unsurprisingly takes great care to highlight potential study biases while dismissing the importance of the outcome benefits found, while ignoring the limited benefit and far more glaring flaws in the Remdesivir study. Fluvoxamine already has full FDA approval. It is safe and inexpensive (a pill costs about $1). Given what we are seeing with the patented and expensive drugs like Remdesivir (a course costs about $2,400), perhaps fluvoxamine’s small price tag is the problem.

As if this all weren’t dispiriting enough, we have undoubtedly spent so much on Remdesivir because hospitals have a major financial incentive to administer it. The Centers for Medicare & Medicaid Services established a system that provides a 20% bonus to each hospital’s bill to encourage them to use Remdesivir and other EUA approved high cost, patented medications.

The only way any of this will change is if we create an independent, well-funded government body dedicated to conducting fairly designed and transparent research studies of repurposed generic treatments. While we certainly must encourage innovation, we cannot afford to overlook cheap and effective solutions that are already at our disposal. But that clearly will not happen until we break the strangle-hold that pharmaceutical companies have on the approval process.

Problem #2: Kids don’t die from Covid-19, why give them Remdesivir that is known to cause harm to the kidney and liver?

As Steve Kirsch pointed out in his Substack article titled, “Do 0 deaths in 2 years justify a vaccine mandate?”:

UCSF Professor Aditi Bhargava brought his UK FOIA request to Steve’s attention who shared it:

The request was:

​Please supply deaths caused solely by covid 19, where covid is the only cause of death listed on the death certificate, broken down by age group and gender between feb 2020 up to and including dec 2021.

Here is the most interesting part of the full response which covered nearly two years since the very start of the pandemic: the number of young people in the UK who died solely from COVID:

If you are under age 24, your chance of dying from covid-19 is ZERO.

Remdesivir Side Effects For Healthcare Professionals

Applies to remdesivir: intravenous powder for injection, intravenous solution

General

The most common side effect in healthy subjects was increased transaminases. The most common side effects in patients with coronavirus disease 2019 (COVID-19) were nausea, increased AST, and increased ALT.[Ref]

Hepatic

In studies in healthy subjects, increases in ALT, AST, or both in those who received this drug were grade 1 (10%) or grade 2 (4%). In a clinical study of patients with COVID-19, any grade (at least 1.25 times the upper limit of normal [1.25 x ULN]) laboratory abnormalities of increased AST and increased ALT were reported in 33% and 32% of patients, respectively, receiving this drug compared with 44% and 43% of patients, respectively, receiving placebo; at least grade 3 (at least 5 x ULN) laboratory abnormalities of increased AST and increased ALT were reported in 6% and 3% of patients, respectively, receiving this drug compared with 8% and 6% of patients, respectively, receiving placebo. In a clinical trial in hospitalized patients with severe COVID-19 receiving this drug for 5 or 10 days, any grade laboratory abnormalities of increased AST and increased ALT were reported in 40% and 42% of patients, respectively; at least grade 3 laboratory abnormalities of increased AST and increased ALT were both reported in 7% of patients. In a clinical trial in hospitalized patients with moderate COVID-19 receiving this drug for 5 or 10 days compared to standard of care, any grade laboratory abnormalities of increased AST and increased ALT occurred in 32% and 33% of patients, respectively, receiving this drug and 33% and 39% of patients, respectively, receiving standard of care; at least grade 3 laboratory abnormalities of increased AST and increased ALT occurred in 2% and 3% of patients, respectively, receiving this drug and 6% and 8%, respectively, receiving standard of care.[Ref]

Very common (10% or more): Increased transaminases, increased ALT, increased AST

Common (1% to 10%): Increased aminotransferase levels (including ALT, AST, or both), increased bilirubin

Uncommon (0.1% to 1%): Increased hepatic enzyme, hypertransaminasemia, increased liver function tests[Ref]

Renal

Very common (10% or more): Decreased CrCl (based on Cockcroft-Gault formula; up to 19%), decreased estimated glomerular filtration rate (eGFR; up to 18%), increased creatinine (up to 15%)

Uncommon (0.1% to 1%): Decreased GFR, acute kidney injury[Ref]

Hematologic

Very common (10% or more): Decreased hemoglobin (up to 15%), decreased lymphocytes (up to 11%), prolonged prothrombin time

Frequency not reported: Prolonged INR[Ref]

In a clinical study of patients with COVID-19, the incidence of prolonged prothrombin time or INR (mostly grades 1 to 2) was higher with this drug compared to placebo; no difference was observed in the incidence of bleeding events between the 2 groups.[Ref]

Metabolic

Very common (10% or more): Increased glucose (up to 12%)[Ref]

Gastrointestinal

Common (1% to 10%): Nausea[Ref]

Nervous system

Common (1% to 10%): Headache

Uncommon (0.1% to 1%): Seizure

Frequency not reported: Generalized seizure[Ref]

Dermatologic

Common (1% to 10%): Rash

Frequency not reported: Angioedema[Ref]

Other

Uncommon (0.1% to 1%): Infusion-related reactions, increased blood alkaline phosphatase[Ref]

Cardiovascular

Sinus bradycardia generally normalized within 4 days after the last dose of this drug without additional intervention.[Ref]

Uncommon (0.1% to 1%): Decreased heart rate

Postmarketing reports: Sinus bradycardia[Ref]

Local

Uncommon (0.1% to 1%): Injection site erythema

Frequency not reported: Administration site extravasation[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Hypersensitivity

Frequency not reported: Anaphylaxis

Postmarketing reports: Anaphylactic reaction, hypersensitivity[Ref]

Problem #3: The FDA Rubber-Stamped Remdesivir for Infants WITHOUT Evidence of Safety or Efficacy

04/27/22

By Madhava Setty, M.D.

… the FDA’s decision to approve the “therapy,” marketed under the name Veklury, is supported by a clinical study conducted on infants 4 weeks and older weighing a minimum of 6.6 pounds.

The study will not be completed until February 2023. There are no published results.

Gilead Sciences, maker of remdesivir and sponsor of the study, provided the following details in a company press release:

• A total of 53 hospitalized pediatric patients were enrolled in the clinical study.

• 72% suffered adverse events.

• 21% suffered serious adverse events determined to be unrelated to the drug.

• Three children died from either underlying conditions or COVID-19.

Nevertheless, Gilead Science assured that “no new safety signals were apparent for patients treated with Veklury.”

The study was of single-arm, open-label design.

A single-arm study has no control group, making it impossible to compare its effectiveness against standard of care.

Open-label means participants and investigators were aware they were receiving the drug, making it impossible to separate placebo from drug effect.

The World Health Organization (WHO) in November 2020 recommended against the use of Remdesivir to treat COVID-19 …

The FDA explains its long-standing support of Remdesivir use in adults here, citing six studies that had the greatest impact on the agency’s position.

Here is a summary of the findings of each study from the FDA’s webpage:

1. ACTT-1 Trial: Time to clinical recovery was shortened from 15 days to 10 through the use of remdesivir. There was no difference in mortality. The drug was no better than placebo when administered to patients who required high-flow oxygen, non-invasive respiratory support, mechanical ventilation or extracorporeal membrane oxygenation at baseline. A benefit was seen only in patients who required low levels of supplemental oxygen.

2. Discovery Trial: There was no clinical benefit of remdesivir in hospitalized patients who were symptomatic for >7 days and who required supplemental oxygen. There was no difference in mortality between remdesivir and standard of care. Investigators judged three of 429 participants who received remdesivir died from the drug.

3. WHO Solidarity Trial: Remdesivir did not decrease in-hospital mortality or the need for mechanical ventilation compared to standard of care. Four hundred and forty patients in this study were also enrolled in the Discovery trial above.

4. Journal of the American Medical Association (moderate disease): After 10 days of treatment with remdesivir, clinical status was not significantly different from standard of care.

5. New England Journal of Medicine (severe disease): No difference between five and 10 days of remdesivir treatment. No placebo group, thus “the magnitude of benefit cannot be determined.”

6. PINETREE study: Three consecutive days of IV remdesivir resulted in an 87% relative reduction in the risk of hospitalization or death when compared to placebo.

The first five studies used to justify the FDA’s approval of Remdesivir showed little, if any, benefit to hospitalized patients with moderate or severe disease.

This is in contrast to the sufficiently proven benefit of off-label use of the previously licensed medications Hydroxychloroquine and Ivermectin.

It's Time to Follow the Science. Join our Campaign!

… In reporting on the FDA’s approval of remdesivir for infants and young children, CNN found someone to support the FDA’s decision.

CNN wrote:

“The FDA’s approval of Remdesivir for young children is ‘great,’ said Dr. Daniel Griffin, an instructor in clinical medicine and associate research scientist in the Department of Biochemistry and Molecular Biophysics at Columbia University.”

Safety ‘not established’ in pediatric patients

Not only is there scant evidence that Remdesivir is an effective treatment for COVID-19, the drug’s safety is debatable.

With regard to its use in infants, even the FDA must acknowledge nobody knows how safe it is.

After all, the manufacturer’s label states:

“The safety and effectiveness of VEKLURY (Remdesivir) have not been established in pediatric patients younger than 12 years of age or weighing less than 40 kg.”

With regard to pharmacokinetics (where the drug distributes in the body) the label states:

“The pharmacokinetics of VEKLURY in pediatric patients have not been evaluated.”