Iowa is one of six states selected by the U.S. Department of Health and Human Services (HHS) to receive a shipment of the drug remdesivir, and on Saturday HHS announced it will allow state health agencies to begin distributing the antiviral drug to treat COVID-19 patients.
Remdesivir is the only drug currently approved to treat COVID-19. The FDA used its emergency authorization process to approve the drug for patient treatment on May 1. Prior to that, the drug was only authorized for use in clinical trials. The University of Iowa Hospital and Clinics was one of the medical institutions participating in those trials. UIHC began its clinical studies on March 31.
The FDA granted the emergency approval following the announcement of the results of a study conducted by the National Institutes of Health that found using remdesivir reduced recovery time in COVID-19 patients by an average of four days. Patients who received the drug in the study took an average of 11 days to recover, while those treated with a placebo recovered in 15 days.
Remdesivir inhibits the virus’ ability to replicate, the study concluded.
Dr. Anthony Fauci announced the results of the study to the media during an April 29 photo opportunity with the president in the Oval Office. Many public health professionals considered the move controversial, because such announcements aren’t typically made until a study’s results are published in peer-reviewed journal.
The same day Fauci made his announcement, The Lancelet, one of the world’s leading peer-reviewed medical journals, published a study that concluded use of remdesivir “was not associated with a difference in time to clinical improvement.” The clinical trials for the study were conducted in 10 hospitals in Hubei, China. The trials had to be terminated earlier than researchers planned when they ran short of volunteers willing to participate.
On Sunday, the Iowa Department of Public Health reported another 287 Iowans have tested positive for COVID-19, including two residents of Johnson County and eight residents of Linn County. The newly reported cases bring the total number of confirmed cases in the state since March 8, when the virus was first detected in Iowa, to 11,959.
According to IDPH, 5,154 of those who tested positive are now considered recovered, leaving 6,805 Iowans with active cases of the virus. A total of 265 Iowans have died from COVID-19, including 13 people whose deaths were reported by IDPH on Sunday.
The shipments of remdesivir to the states — New Jersey, Illinois, Maryland, Michigan, Connecticut and Iowa — began on Thursday. HHS allocated 10 cases of the drug to Iowa. Each case contains 40 vials of the drug.
According to Politico, “HHS will ship 14,400 vials of the drug to state health departments, putting the onus on them to decide which hospitals get some of the country’s limited supply. Previously the administration had sent a total of 35,360 vials straight to a handpicked list of hospitals, via its contractor AmerisourceBergen.”
The Trump administration’s handling of remdesivir distribution has been described as chaotic and concerns have been raised over how it is deciding where to ship the drug.
“The administration provides zero explanation for why and how the initial shipments were made,” Rachel Sachs, an associate professor of law at Washington University in St. Louis who studies food and drug regulation, told Politico.
“A senior HHS official told Politico earlier this week that the government hadn’t finalized its distribution plans before it started handing out the drug this week,” the news site reported on Saturday. “On Friday, as the backlash mounted, White House press secretary Kayleigh McEnany said that Deborah Birx, the administration’s coronavirus response coordinator, would be working on the remdesivir distribution effort.”
Remdesivir is manufactured by Gilead Sciences, a California-based company. The company developed it as a general antiviral drug, but proposed remdesivir as a treatment for the Ebola virus, after a laboratory tests in animals showed it was effective. The drug is still not approved for treating Ebola, and its possible future use for that virus is uncertain after the December 2019 publication of the results of large-scale clinical trials in Democratic Republic of Congo that found remdesivir was less effective than two other drugs in treating Ebola.
Gilead is donating 607,000 vials of remdesivir to the U.S. government, which is enough to treat about 78,000 patients, according to HHS. It is those donated vials that HHS is distributing.
The company has not yet fixed a price for it drug, but the Institute for Clinical and Economic Review (ICER), an nonprofit that analyzes drug prices, estimates that if remdesivir proves to be an effective in reducing hospital stays for COVID-19 by four days, the drug will cost approximately $390 for the recommended 10-day course of treatment. The ICER analysis also estimates that price will go up to $4,500, if the drug is shown to decrease the virus’ mortality rate.
According to ICER, the amount of remdesivir needed for a 10-day course of treatment costs $10 to manufacture.