Gilead Sciences, the drug company behind the experimental Covid-19 therapy remdesivir, has upped the number of doses it’s donating to the federal government from 607,000 to around 940,000, STAT has learned.
The new number appeared, with no acknowledgement of the shift, in a letter that a U.S. Department of Health and Human Services official sent to governors on Saturday.
“The numbers keep changing,” said Rep. Lloyd Doggett (D-Texas), who provided a copy of the letter to STAT. “There was no explanation of the change.”
Then, on Monday, in a call with leaders of physician and hospital groups, the HHS assistant secretary for preparedness and response explained that the federal agency would receive additional doses of the drug from Gilead in June, according to two participants on the call. Both asked not to be named to ensure continued access to future HHS calls. One said that at least some of the drug would be in a form useful for treating children.
An HHS spokesperson confirmed Monday evening that Gilead would be donating more doses, bringing the total to 940,000 vials. (Gilead did not immediately return a call seeking comment.)
Those 300,000 or so extra doses would be enough to treat between 30,000 and 55,000 additional patients, depending on whether a person gets six or 11 doses. This could help alleviate concerns that there will not be enough of the medication for all eligible patients. Last week, in another, similar call, HHS officials had said they could not promise that more of the drug would be manufactured and available before the end of August, according to the Greater New York Hospital Association.
Physicians had been worried that they’d end up in the same wrenching situation they’d been in before the authorization of remdesivir, where they could provide a patient with oxygen or mechanical-breathing help, but nothing that could help the body beat back the virus itself.
“You could see them about to head to the ICU in the days ahead,” Rochelle Walensky, chief of infectious diseases at Massachusetts General Hospital, said last week, “and it’s an impossible position, it’s awful, to have this feeling of impending doom without a plan.”
They also worried about the most ethical way to ration something so scarce. The medication is the only therapy that has been shown, in a rigorous clinical trial, to help patients with Covid-19, by reducing the time it takes them to recover. In early May, shortly after it was authorized to be used on an emergency basis, physicians were baffled as to why certain coronavirus-slammed hospitals received boxes of the drug and others received none.
“It was beyond confusing; it was crazy-making,” said Amy Compton-Phillips, the chief clinical officer of Providence Health & Services, which includes 51 hospitals and over 1,000 clinics from Alaska to Texas. “If they do this without any warning and without any plan and without any transparency, it makes us not trust that the system is fair and equitable.”
The federal government then announced that state health departments would receive future shipments and decide how to allocate them to medical centers, though it was still unclear to hospitals how the federal government was determining how much of the drug should go to each state.
The first hint of an explanation was an email that hospitals received from HHS in the wee hours of Monday, May 11, asking for the number of confirmed and suspected Covid-19 inpatients, and how many in each group needed intensive care. “Your response will inform current and future distributions of remdesivir, a promising drug known to help coronavirus patients, to areas of the country with the greatest need,” said the email, which a hospital system representative provided to STAT.
The agency has been using those data from individual hospitals, in combination with numbers tracked by state health departments and the Centers for Disease Control and Prevention, “to ensure we have the full picture,” an HHS spokesperson told STAT in an email last week. But this week’s request for those data was abruptly canceled on Monday, the day it was due, because the agency didn’t need more data at the moment.
Future allocations to each state, the letter to the governors said, would be based on these numbers “in a data-driven, objective manner proportional to the number of hospitalized COVID-19 patients in each state.”
The idea that each shipment out to states would be based on a weekly collection of data was concerning to some physicians, as they worried there might be a lag.
“They only said, ‘We want to hear from hospitals how many needy patients we have’ — but next week we could have twice as many needy patients!” said Judith Feinberg, an infectious disease specialist at West Virginia University, last Friday. She said she was especially concerned now that states are beginning to open back up, that new surges of coronavirus cases might appear.
“It’s the story that won’t die,” she said, about the confusion surrounding how the drug was being allocated. “Let’s face it, the feds botched this big time. … By what principles is the drug being distributed? Is there fairness to this system? Is there transparency? Is there any way to know what’s really going on?”
Even once health departments took over the allocations to hospitals, doctors felt that there wasn’t enough clarity on when new delivers of the drug would arrive in each state. If they knew how much of the drug was coming their way, and when, they could better plan its use. “As a treating physician, the most important thing is to know the limits of the supply. Is this delivery the last, or is there more coming? Our goal is to save as many lives as we can,” said Helen Boucher, chief of the Division of Geographic Medicine and Infectious Diseases at Tufts Medical Center.
Part of the issue is that the National Institute of Allergy and Infectious Diseases has not yet released the fine-grained data on which coronavirus patients benefitted most from remdesivir in the clinical trial, which also hampers doctors’ decisions in figuring out who they should treat if they only have a limited supply.
Both politicians and doctors alike also wanted to know how the federal allocation system actually worked.
In the letter to governors, the HHS official gave an example of how the numbers had worked out for one state, but it was like a nightmarish question on a high school math exam. There was no way to extrapolate how the calculations had been made.
“Maryland has 677 ICU patients and 1,381 non-ICU patient with confirmed or presumed cases of COVID-19,” the letter said. “As such, Maryland will receive 169 cases or 6,760 vials of remdesivir, which is sufficient for 1,126 patients on a six-vial course or 614 patients on an 11-vial course.”
As Doggett put it, “What is the formula for getting this to the states? … They are rationing; I want them to be rational.”