Pharmaceutical giant Gilead recalled one batch of its COVID-19 antiviral drug Veklury, the brand name for remdesivir, after glass particles were discovered in vials of the drug, Newsweek reported.
A company investigation, prompted by a customer complaint, confirmed the presence of glass, according to the company recall notice posted on the U.S. Food and Drug Administration (FDA) website.
Gilead distributed the batch, identified as Veklury lot No. 47035CFA across the U.S. beginning on July 16. The batch isn’t set to expire until November 2025.
If a product containing glass is injected, it may result in localized swelling or, “the glass particulate can potentially travel, through the blood vessels, to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death,” the company warned in the recall notice.
Gilead said it is informing distributors and customers via a letter sent to UPS Next Day Air. The letter advises facilities that have the recalled drug to stop using it and return the vials to the company following the instructions in the letter.
Gilead said it has not received any reports of adverse events related to this lot.
The company didn’t say where the lots were manufactured or by whom and did not respond to The Defender’s request for comment on those questions.
Lawsuit alleges remdesivir containing glass particles led to man’s multiple strokes, leg amputation
This isn’t the first time glass has been found in remdesivir. In December 2021 the company confirmed the presence of glass particles in two lots of Veklury/remdesivir after a different customer complaint triggered a similar investigation.
The company also issued a recall at that time for the contaminated lots.
A Michigan man, Daniel Nowacki, who received five doses of remdesivir between Nov. 10-24, 2021 — including from the lots that were later recalled — sued Gilead, alleging the contaminated lots caused two strokes and a leg amputation, leaving Nowacki unable to care for himself.
Gilead sought to have the case dismissed, claiming the company was protected under the Public Readiness and Emergency Preparedness (PREP) Act, because remdesivir was under emergency use authorization (EUA) when it was administered to Nowacki.
However, in a July 20, 2023 ruling, Judge Carol Kuhnke of the Circuit Court for the County of Washtenaw rejected Gilead’s motion to dismiss. Kuhnke said that the PREP Act doesn’t extend to issues like contamination for EUA products.
The case is proceeding through the courts.
Remdesivir ‘doesn’t work,’ yet continues to be marketed, despite safety issues
The FDA granted EUA for Gilead’s remdesivir in May 2020. In October 2020, the drug became the first COVID-19 treatment to receive full FDA approval, for people ages 12 and up, despite widespread concerns regarding its efficacy.
In April 2022, the FDA expanded approval of the drug to treat COVID-19 patients as young as 28 days and weighing 7 pounds, CNN reported.
Gilead initially developed the experimental drug in collaboration with the Centers for Disease Control and Prevention and the Army Medical Research Institute of Infectious Diseases, with U.S. taxpayers footing the bill for $70.5 million.
The FDA granted remdesivir EUA even though the clinical trials showed the drug wasn’t very effective for treating COVID-19. Earlier, the drug was also shown to be ineffective against the ebola virus, which it was originally designed to treat.
Nonetheless, Gilead repurposed the drug to treat COVID-19, Forbes reported in its 2021 exposé, “The Strange Story Of Remdesivir, A Covid Drug That Doesn’t Work.”
“What’s weird about remdesivir is that it hasn’t been held to the same standards as other drug candidates,” according to Forbes.
After authorization, remdesivir quickly became the standard-of-care drug in the U.S. Despite evidence of limited efficacy and serious side effects, the U.S. government paid hospitals a 20% upcharge for following the remdesivir protocol, plus an additional bonus.
The World Health Organization (WHO) recommended against the use of remdesivir to treat COVID-19 as early as November 2020, after finding no evidence that it improved outcomes, Reuters reported.
The WHO based its recommendation against the use of the drug on an evidence review that included data from four international randomized trials involving more than 7,000 patients hospitalized with COVID-19.
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And in the WHO’s own Solidarity Clinical Trial for COVID-19 treatments, the agency reported that remdesivir not only failed to produce any measurable benefit in terms of mortality reduction, but that it also didn’t reduce the need for ventilators, or the length of hospital stays.
After reviewing the evidence, the WHO’s advisory panel said the drug, which has to be given intravenously and is therefore costly and complex to administer, has no meaningful effect on death rates or other important outcomes for patients, according to Reuters.
Yet it remained the standard of care in U.S. hospitals — at a cost of more than $3,000 per patient.
By February 2021, the drug was used to treat 1 in 2 patients hospitalized for COVID-19 in the U.S. The drug has netted billions for the company. It brought in $5.6 billion in 2021 according to Fierce Pharma, just when it appeared that sales would be tapering off.
In addition to efficacy concerns, the drug has also been found to cause elevated liver enzymes and is linked to lethal side effects including multiple organ failure, septic shock and hypotension.
Hospital protocols that included remdesivir reportedly led to numerous serious injuries and deaths among people hospitalized with COVID-19.
Yet, the mainstream medical media continued to tout remdesivir as a treatment for COVID-19, even after the latest recall.
