In search for COVID-19 treatments, consumer group pushes drugmaker Gilead to test alternative to remdesivir
The pharmaceutical company that makes remdesivir — the only medication that has emergency authorization to fight COVID-19 — should also be conducting human trials on a related drug with strong potential, according to a citizen advocacy group that believes the alternative could be more effective, less expensive and easier to produce.
Washington, D.C.-based Public Citizen sent a letter dated Tuesday to the CEO of Gilead Sciences and top federal regulators, urging the company and the government to work together to move forward with clinical trials of the drug “or publicly provide evidence why it is not scientifically or medically feasible to develop this drug in parallel with its close analogue, remdesivir.”
Failing either of those options, the company should “release permission so other researchers can pursue it,” said Public Citizen health researcher Michael Abrams, who crafted the letter. The nonprofit group, founded by Ralph Nader, has long advocated for greater corporate responsibility.
Officials from Public Citizen, joined by two drug researchers from Texas, suggested in the letter “there are significant financial incentives” for Gilead to stick with remdesivir over the lesser-known drug, known only as GS-441524.
Specifically, the patent on GS-441524 dates to around 2009, compared with remdesivir about five years later, meaning that Gilead has exclusive rights to produce remdesivir further into the future. Remdesivir is an expensive drug, priced at $390 per dose, which comes to $2,340 for each patient treated over the course of five days.
Gilead spokesman Chris Ridley said the decision to move forward with remdesivir was based on “available evidence” indicating that remdesivir generated more of a key virus-fighting molecule and was more effective against the new coronavirus than the other drug.
“Reinforcing this decision was the ability to rapidly progress clinical trials with remdesivir, given the urgency of the global pandemic,” Ridley added in an email response. Remdesivir had already been tested in humans, so the company already had the safety data that is essential to assessing drug treatments, he added.
“In contrast, there are no formal toxicology studies on GS-441524 at dosing levels required to demonstrate efficacy in humans,” he added. “Existing stockpiles of remdesivir also supported the rapid initiation of clinical trials and compassionate use.”
Nevertheless, the company has “initiated additional pre-clinical studies to further compare remdesivir and GS-441524,” Ridley said, without providing details. “We will publish the data as soon as they become available.”
Previous trials have concluded that COVID-19 patients given remdesivir recovered faster than those who did not receive the drug, a complex compound in limited supply that is being rationed by the federal government. The studies led the Food and Drug Administration to grant emergency use authorization to use the drug to treat COVID-19.
The faster recovery times seen with remdesivir are helpful to both patients who are suffering and hospitals at risk of becoming overwhelmed with caseloads, doctors said.
The federal agencies that regulate and approve new drugs noted that it’s typically drugmakers and academic institutions that undertake trials. Officials at the National Institute of Allergy and Infectious Diseases — the agency led by Dr. Anthony Fauci, the nation’s top infectious disease expert — referred questions to Gilead.
Victoria Yan, a graduate research assistant in medicinal chemistry at University of Texas MD Anderson Cancer Center in Houston, was a co-signer of the letter to Gilead, as was Florian Muller, a professor of cancer medicine at MD Anderson who does drug research. Both have been advocating for further experimentation on GS-441524 for months.
Yan noted that the National Institutes of Health or any other government agency that wanted to conduct trials on the drug would need Gilead’s approval, because the company holds the patent. But the letter also urged Gilead to allow academics or the federal government to carry out research on humans if the company is unwilling.
Yan pointed to a study from April that found GS-441524 was effective in fighting SARS-CoV-2, the novel coronavirus that causes COVID-19, in human cells in the laboratory.
The drug’s advocates also say GS-441524 takes fewer steps to produce than remdesivir and, because of its properties, might be able to be delivered orally or through an aerosol directly into the lungs. Remdesivir is given intravenously, although Gilead is studying ways to deliver it through an aerosol.
Dr. Robert Murphy, executive director of the Institute for Global Health at the Northwestern University Feinberg School of Medicine, said the effectiveness of GS-441524 needs to be studied further to draw a conclusion. “Try it in humans,” he suggested in an email to the Tribune when asked about its potential.
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