As the world struggles to find solutions to the pandemic, numerous treatments have been proposed, offered by sources ranging from credible experts to fringe crackpots. The U.S. government has made both formal and informal suggestions, but at this time the only medicine with provisional FDA approval is Gilead’s remdesivir, a nucleoside analogue prodrug. The curious and convoluted story of this medication raises questions, however, both about its efficacy and safety, as well as the possible political and financial motivations behind the FDA recommendation.

Gilead debuted remdesivir in 2009 as a potential cure for hepatitis C. After proving ineffective, the drug was proposed as treatment both for ebola and the Marburg virus, but no benefits were seen in the clinical trials. Based on animal research that suggested activity against the corona viruses, a Chinese study earlier this year took another look at this three-time loser as a treatment for COVID-19. Although the study was discontinued early owing to serious safety concerns, preliminary data showed no improvement in either clinical symptoms or mortality rates. Even more telling, the research found no detectable decrease in viral load in the upper respiratory tracts of infected patients.

Nevertheless, the governmental National Institute of Allergy and Infectious Diseases—whose director is Anthony Fauci, well-known as the spokesperson for White House Corona Virus Task Force—launched the ACTT-1 study on February 21st to look at whether or not remdesivir offered any benefits to patients with COVID-19. On March 20th, President Donald Trump announced to the nation that remdesivir has been approved for extended use access. Two days later, an NIAID team met behind closed doors and agreed to change study parameters. Instead of a set end date, the ACTT-1 research would conclude when 400 patients had recovered, with the revised study evaluating only three, rather than eight, general criteria. The update in study methodology was followed the next day, on March 23rd, by Gilead’s decision to voluntarily suspend extended use due to supply shortages.

The well-connected pharmaceutical company, whose past board members include conservative Secretaries of State George Schultz and Donald Rumsfeld, had, in fact, begun preparations early in 2020 for approval and distribution of remdesivir. In January, Gilead not only began testing of the orphaned drug for COVID-19 benefits, the reactors at its Edmonton, Alberta plant were also reactivated for the production of large quantities of remdesivir, while the raw materials poured in from their contract manufacturers. On February 2nd, one hundred kilograms of residual stock from the Ebola production was sent to the factory in LaVerne, California to be packaged in vials. When a fresh batch of the drug was completed in Edmonton in April, Gilead was poised for formal FDA approval for extended use on May 1st. Although public announcements for extended use access had first occurred on March 20th and, later, on May 1st, it has been revealed that the earliest compassionate use for COVID-19 patients had actually begun on January 25th, long before study outcomes indicating effectiveness.

As the available facts demonstrate, both production and clinical use of remdesivir occurred before the tax-payer funded ACTT-1 study began. Extended use continued despite Chinese study evidence showing the drug was ineffective and risky, and the NIAID modified its study just two days after the drug was enthusiastically touted by the White House. Many have since criticized the ACTT-1 study for its failure to establish whether remdesivir improves mortality rates in patients, as well as for flaws in its research methodology.

In the face of facts that indicate that remdesivir was likely approved not on the basis of solid scientific evidence but largely for political and financial gain, we can only wait for objective findings from the WHO’s international Solidarity Trial to either deny or confirm the conclusions of the ACTT-1 study. In the meantime, NIAID’s own Clinical Director, H. Clifford Lane, M.D. may have said it best when he characterized the use of remdesivir for COVID-19 as “better than nothing”. On the other hand, as a drug with an number of serious known adverse effects, including respiratory failure, there seems to be insufficient proof to show that remdesivir for COVID-19 is truly better than receiving no treatment at all.