With difficulty getting more COVID-19 drug, SC hospital asks for lawmakers’ help
A drug that has shown success in treating COVID-19 patients and is being used by at least two South Carolina hospitals has become difficult to access, and now one Columbia pharmacist is asking for help from legislators.
Julie Ann Justo, a clinical pharmacist at Prisma Health-Midlands, wrote a letter to legislators on Wednesday asking lawmakers to help intervene on Prisma’s behalf to help the Columbia hospital get access to a donated supply of remdesivir, an antiviral drug manufactured by Gilead Sciences that has shown some promise in initial trials.
Justo in her letter said the hospital is caring for 50 patients infected with the coronavirus, which causes the sometimes severe respiratory disease COVID-19. Altogether, Prisma has cared for 233 patients with COVID-19.
And now, Prisma says it wants to be able to give the drug to patients outside of the clinical trials with the treatment before their condition worsens. But the hospital has been denied access, unlike a handful of other hospitals, raising questions about how the drugs are being doled out.
A study published by Gilead last month showed at least half of patients improved who were treated with the drug for five days, and more than half of those treated were discharged from the hospital in 14 days.
Remdesivir is one of many COVID-19 treatments and vaccines being used in clinical trials, but it gained recognition when the results of an early trial were touted by Dr. Anthony Fauci, director of the National Institutes of Allergy and Infectious Diseases.
Fauci also sits on President Donald Trump’s COVID-19 task force.
The Food and Drug Administration fast-tracked remdesivir’s approval process last week to authorize emergency use of the drug in presumptive or confirmed COVID-19 adult and child patients hospitalized with a severe form of the disease.
Gilead announced it would donate another 1.5 million doses of the drug to the federal government to allocate to hospitals around the country. AmerisourceBergen was named Monday as the government’s distributor of the drug to be sent to hospitals with intensive care units and other hospitals most in need for the drug.
Prisma, Justo wrote to lawmakers, did not make the list.
Why not? Justo doesn’t know because the federal government didn’t explain, she told The State.
“On behalf of Prisma Health-Midlands, I emailed ... the same day and received a response from the AmerisourceBergen Remdesivir Team stating, “At this time, we do not see your facility on the list of facilities that the U.S. government has designated to receive donated remdesivir,” Justo wrote. “When we inquired regarding an appeals process, we were told by the same team there was currently no such process for an appeal. It is currently unknown how the U.S. government has prioritized selection of U.S. hospitals that are most in need of this donated supply of remdesivir.”
Only a hospital in Los Angeles, a hospital in Nashville, and 10 hospitals in the northeast United States have confirmed they have been approved to receive remdesivir for treatment outside of a trial, according to a University of California San Francisco’s School of Pharmacy survey.
Aside from lawmakers, Justo also is asking the federal government to be more transparent and release a list of hospitals, or at least counties, across the United States that will get additional doses of remdesivir.
“To be fair, I’m not making any suggestion of what criteria should be used,” Justo told The State. “But what were asking for is just transparency and communication of the process to help minimize the burden on local health care systems.”
Prisma is able to obtain and administer remdesivir for the ongoing trial to see how effective it is for treating patients with COVID-19.
However, not all COVID-19 positive patients qualify for the trial.
To qualify, a test sample from a positive patient has to be collected within four days of them being enrolled in the trial, meaning if someone gets diagnosed, but doesn’t need to be admitted to a hospital until five or more days after they’ve had the swab, they can’t be enrolled.
Prisma officials would like to be able to administer the treatment to people in the hospital who may not qualify for the ongoing trial before their condition worsens, requiring them to be put on a ventilator, said Edwin Hayes, principal investigator for the remdesivir trials at Prisma.
“We’re still seeing plenty of sick people coming in, we’re still seeing people who are having terrible complications from COVID-19, and we want to give them every opportunity to be improved and healthy to save their lives,” Hayes said.
Lexington Medical is participating in Gilead’s “expanded access program,” which allows for a select group of severe COVID-19 patients to be treated with remdesivir at community hospitals. However, as of Monday, the hospital did not yet have 10 patients who qualify for the remdesivir program, the threshold required to start the program.
Reporter Isabella Cueto contributed to this report.
