The U.S. government’s management of a potentially lifesaving COVID-19 drug is raising questions about which hospitals will get access to the therapy first, and on what basis.
On Friday, the White House said it will have Deborah Birx, a member of the coronavirus task force, help oversee distribution of Gilead Sciences Inc.’s COVID-19 drug following questions about the opaque process for getting the therapy to U.S hospitals.
“She is going to be working and consulting as to where this drug should go,” White House spokeswoman Kayleigh McEnany said at a briefing Friday. “She really has the best grasp as to how that should be distributed.”
Pharmacy staff at the University of California, San Francisco, have been attempting to figure out where the intravenous infusion is currently available. Peter Chin-Hong, an infectious-disease physician at UCSF, said the group believes 25 hospitals have been authorized to receive the drug. Others, even some in areas hit hard by the disease, haven’t been getting allocations, Chin-Hong said.
“It’s been hard to know why some places are getting things and some places aren’t,” Chin-Hong said. “Speed is an issue. Every day you wait in a pandemic, you lose lives.”
After the medicine was given an emergency use authorization in the U.S. last week, Gilead donated to the federal government a portion of the 1.5 million doses it has manufactured. The distribution logistics are being handled by wholesaler AmerisourceBergen Corp. But which hospitals get the drug is decided by the federal government, which so far hasn’t said publicly what the exact criteria or data are used to make the decisions.
“The challenge is: There’s just not enough drug,” said Angela Caliendo, secretary of the board of directors of the Infectious Diseases Society of America and vice president and director of general internal medicine at Brown Medicine, which is affiliated with Brown University’s medical school. “Some centers are getting it, some centers are not getting it. It’s not clear how the decisions are being made.”
In Michigan, two members of Congress sent a bipartisan letter to Robert Kadlec, assistant secretary for preparedness and response at the U.S. Department of Health and Human Services, asking for information about how the drug is being allocated. They said that hospitals in the state were denied access, including Michigan Medicine at the University of Michigan, which has 80 COVID-19 patients currently in its care.
“We need to ensure that hospitals around the country are able to access medicines so patients can recover from Covid,” said Rep. Debbie Dingell, a Democrat, who co-signed the letter with Republican Rep. Fred Upton. “If leading educational hospitals don’t have access to doses, it indicates there may be a problem.”
Gilead declined to comment.
In a statement, AmerisourceBergen said that “hospitals with intensive-care units and other hospitals that the U.S. government deems most in need will receive priority in the distribution of donated remdesivir,” and that “the U.S. government will coordinate the distribution of remdesivir to regions most heavily impacted by COVID-19.”
The company referred further questions to the federal government. Officials from HHS didn’t respond to emails and telephone calls asking for comment.
The lack of clarity is weighing on doctors who don’t know what to tell their patients or their families when the only treatment authorized by the federal government isn’t available.
“There is no public place anyone can go to get factual information about how the distribution process is going or what metrics are used to determine how to allocate the limited supply of remdesivir,” said Michael Ison, a professor of medicine in infectious diseases at Northwestern Medicine Feinberg School of Medicine in Chicago. “That leaves a growing number of patients who are admitted to the hospital who could benefit from this therapy that aren’t.”
Since mid-April, Chicago has reported more than 600 new daily cases and 20 to 50 daily deaths from the disease, according to the city’s health department. Ison declined to say how many patients are being treated at his hospital. San Francisco’s outbreak is smaller, with about 30 to 60 new cases daily since mid-April, and fewer than one death on average a day.
“Any time there is too much demand for a very limited supply, especially for something that’s potentially life-saving or improving the quality of life, society demands clarity in the distribution,” Ison said. “Currently there is none.”
A mapping project from UCSF shows that a clutch of hospitals in the New Jersey-New York-Boston corridor have access to remdesivir, along with one hospital in Nashville and two in California. New York and New Jersey have particularly large outbreaks and are each reporting several thousand cases per day.
Some doctors in less hard-hit areas said they understood why they didn’t get access to remdesivir, though the lack of a clear distribution process was concerning. Cameron Wolfe, associate professor of medicine and an infectious disease specialist at Duke University School of Medicine in North Carolina said it would be odd for his institution to get such a scarce resource when the outbreak has been so much worse more to the north. Explaining it to patients can still be difficult.
“It’s an easier conversation if we can explain the reasoning why we don’t have any, because it’s a limited supply,” he said. “It’s going to hospitals that are slammed. But we don’t have that clarity.”
Public-health organizations also weighed in, calling for a transparent process.
The Infectious Diseases Society of America and the HIV Medicine Association called on Vice President Mike Pence and other administration officials to explain the process. The federal government must ensure the drug is being made available fairly, especially given historical imbalances in access to health care, the organizations said.
“This will be imperative to ensure appropriate patient access, reduce the significant health disparities and adverse outcomes already experienced by Black Americans, Latinx communities and other populations,” they wrote. Clear rules could also “prevent a surge in patients at institutions known or thought to have access to the drug or a crush of requests to transfer patients to these hospitals from those who may not have remdesivir access.”