AFFIRMATION COMPLETE: “Remdesivir is proven to kill lives […] Remdesivir will result with at least 30% deaths of everyone who receives that drug in a hospital for 5 to 10 days”.
REVIEW
On 22 October 2020, the U.S. Food and Drug Administration (FDA) approved remdesivir for the treatment of COVID-19 in hospitalized adult and pediatric patients (12 years of age and older). The antiviral drug works by blocking the replication of SARS-CoV-2, the virus that causes COVID-19.
Since its approval in October 2020, the FDA has expanded remdesivir’s use to high-risk, nonhospitalized patients. The drug’s approval came after data from three randomized clinical trials conducted by the U.S. National Institute of Allergy and Infectious Diseases found that remdesivir decreased the recovery time of hospitalized COVID-19 patients.
Misleading and false claims about remdesivir have circulated since before its approval by the FDA (see here), but the number of such claims increased after its approval. Since January 2021, there have been claims that remdesivir was unsafe and only distributed in Africa (false), that the drug was invented by Anthony Fauci, the director of the U.S. National Institute of Allergy and Infectious Diseases, and billionaire Bill Gates (false), that a global conspiracy was promoting remdesivir (false), and that remdesivir was killing hospitalized COVID-19 patients (false).
Another example of a false claim about remdesivir comes from a video posted on TikTok on 22 March 2022 and subsequently shared on Facebook on 23 March 2022 (see here) that showed chiropractor Bryan Ardis claiming that “remdesivir is proven to kill lives”. Ardis went on to claim that “remdesivir will result with at least 30% deaths of everyone who receives that drug in a hospital for 5 to 10 days”.
The clip of Ardis comes from a 4 March 2022 panel discussion organized by Pennsylvania U.S. State Senator Doug Mastriano; the clip in the Facebook post starts at hour 1:19:30 of the panel discussion. During the panel discussion, Ardis repeated baseless claims he had previously made about remdesivir.
Ardis claimed that reports of COVID-19 causing kidney problems were false and that “the entire kidney failure, multiple organ failure, was the result of remdesivir and had nothing to do with the virus” [1:18:20]. Later, Ardis claimed that remdesivir was “known to cause kidney failure, heart failure and liver failure” [2:03:20]. Previous fact-checks have rated this claim false.
A 21 September 2021 fact-check by The Associated Press stated that damage in kidneys and other organs observed in COVID-19 patients were complications of severe COVID-19, not remdesivir. Though COVID-19 is primarily thought of as a respiratory disease, the infection can impact all parts of the body including the heart, kidneys, and liver. In the case of the kidneys, for instance, kidney damage is a known complication of COVID-19 that can occur in some patients, including those who had no kidney problems before infection. Moreover, as The Associated Press pointed out, a randomized, placebo-controlled trial of remdesivir that involved 1062 study participants with 541 receiving remdesivir, found no evidence of kidney damage or other damages caused by remdesivir[1].
Ardis also claimed that remdesivir is killing people [1:19:30]; similar claims about remdesivir being lethal have also been made by others. However, there is no evidence that remdesivir is killing people. The U.S. FDA based their decision to approve remdesivir for COVID-19 treatment on clinical trials; one clinical trial, called the Adaptive COVID-19 Treatment Trial (ACTT), compared remdesivir treatment to placebo, while another trial compared remdesivir treatment (5 days or 10 days) to standard of care (SOC) treatment. Both trials reported all-cause mortality, which is a measure of all deaths, independent of cause, that occurred during the trial. In the ACTT trial, 14.78% of COVID-19 patients who received the placebo died compared to 10.91% of COVID-19 patients who received remdesivir. In the trial that compared 5 or 10-days of remdesivir treatment to SOC, all-cause mortality was 1.05% for COVID-19 patients who had a 5-day course of remdesivir, 1.55% for those who received a 10-day course of remdesivir, and 2.00% who received SOC treatment. As such, clinical trials that evaluated the safety and efficacy of remdesivir in COVID-19 patients did not observe increased mortality among study participants who received the antiviral drug.
As Emily Heil, a clinical pharmacy specialist in infectious disease at the University of Maryland, told The Associated Press in a 9 February 2022 fact-check: “Through all of these studies, there were zero signals that remdesivir made anything worse”. Moreover, Heil pointed out, “there is really no plausible mechanistic way through which remdesivir could increase your risk of death”.
During the panel discussion, Ardis not only made baseless claims about the safety of remdesivir, he also went on to claim that drugs “like ivermectin, like hydroxychloroquine, like budesonide” were “way more safe and effective” for treating COVID-19 [1:19:00]. This, however, is not true. A large study, published on 30 March 2022, added further evidence that ivermectin is not effective at reducing the risk of hospitalization with COVID-19[2]. The U.S. National Institutes of Health’s COVID-19 Treatment Guidelines Panel recommends against the use of hydroxychloroquine for the treatment of both hospitalized and nonhospitalized COVID-19 patients since current research has found that hydroxychloroquine is neither safe nor effective for treating COVID-19. As for budesonide, an inhaled corticosteroid, the European Medicines Agency’s COVID-19 taskforce has stated that there is currently “insufficient evidence that inhaled corticosteroids are beneficial for people with COVID-19”. Additionally, in September 2020, the U.S. FDA sent a warning letter to a pharmaceutical company for falsely promoting budesonide as a treatment for relieving COVID-19 symptoms, a use that lacks FDA approval.
In short, at a 4 March 2022 panel discussion, Ardis made baseless claims about the safety of the antiviral drug remdesivir. But Ardis’ claim isn’t supported by evidence, as randomized, placebo-controlled clinical trials have not found remdesivir to be lethal.
References
- 1 – Beigel et al. (2020) Remdesivir for the treatment of COVID-19 – Final Report. The New England Journal of Medicine.
- 2 – Reis et al. (2022) Effect of early treatment with ivermectin among patients with COVID-19. The New England Journal of Medicine.
