Does state have enough COVID drug to treat all?
California health officials are distributing what’s left of our reserve of the highly coveted remdesivir, the world’s only effective treatment for COVID-19. And then we may run out.
With demand high and supplies limited by a complex manufacturing process, there are only enough doses of the drug to treat an estimated 800 to 1,440 sick patients until the next delivery in mid- to late June.
As the state moves toward reopening, and an average of 1,800 new cases are diagnosed every day, doctors say a sudden spike in severe illness could force them to confront medicine’s most difficult choice: Who gets medicine when there isn’t enough for everyone?
“If we had a surge of patients, we’d be in trouble,” said Dr. Annie F. Luetkemeyer, an infectious disease physician at Zuckerberg San Francisco General Hospital. “It’s a really tough place to be in.”
Five years ago, the Foster Citybased Gilead Sciences sorted through 1,000 chemical compounds to find the new antiviral
agent. Designed as an Ebola drug, remdesivir was a flop. Now the drug has emerged as the leader of dozens of possible treatments for COVID-19. It won’t be the last drug — or the best — but it is our first.
Braced for a shortfall, hospitals are drafting plans about how to ethically allocate their shares. One idea: a random lottery. Another idea: Give priority to health care workers, who can save the lives of others, or essential workers, who are critical to our daily well-being.
“We have limited supplies, and we have to protect our resources as much as we can,” said UC San Francisco bioethicist Dr. Sirisha Narayana, a member of the UC Critical Care Bioethics Working Group, which is discussing the ethics of allocation at University of California hospitals.
Gilead is donating its supplies of the drug to the federal government, which distributes it to states with the most sick patients.
Then each state divvies it up among their hardest-hit counties. In a Friday delivery, Alameda County is receiving 229 doses, San Francisco 125, San Mateo 116, Santa Clara 104 and Contra Costa 32. With each patient requiring six to 11 doses, that’s only enough for 55 to 101 Bay Area residents.
Then there won’t be any more available until the next shipment arrives.
With no other drugs expected to be approved and marketed until later this year or next, Gilead is now racing to boost production of its handiwork, which speeds up the recovery time of very sick coronavirus patients. Those who receive remdesivir recover in a median of 11 days, compared with 15 days for those who receive a placebo. Death rates are slightly lower — 7.1% vs. 11.9% — but this difference was not statistically significant.
Anticipating demand back in January, Gilead started creating a supply chain capable of large-scale production of the drug, according to the company. But it’s been impossible to scale up quickly enough.
Until federal approval came in late April, “There was no real confirmation that people were going to be using a large number of doses, on such short notice,” said Joseph Fortunak, an organic chemist who helped launch 15 new drugs during his decades in the pharmaceutical industry and studies the remdesivir manufacturing process.
“This was just an experimental drug,” he said. “Companies can’t be making millions and millions of doses if they don’t know that the drug is effective.”
And the complexity of the process limits the ability to rapidly produce vast quantities of the drug, he said.
About 75 different raw materials are needed in a long and linear chemical synthesis process that must be completed sequentially. Production requires fermentation in large sealed reactors. Through process refinements, Gilead is shortening the manufacturing time and has expanded facilities.
Because remdesivir is administered intravenously, production requires sterile manufacturing, which adds another layer of complexity, Fortunak said.
A much larger supply should be available by October. To meet international demand, Gilead has licensed the process to five generic drug companies in India and Pakistan to distribute it to 127 low-income nations.
Braced for hot spots of infection in the coming weeks, federal officials have saved about 10% of the current U.S. allotment in reserve.
In California, the bulk is shipped to Southern California, where there’s been a recent surge of cases. On May 22, Los Angeles County received 4,261 doses. In contrast, more rural Butte County got 23 doses.
“We think about where the greatest need is,” said UCSF’s Narayana. “We may be able to see greater benefits in Southern California, where hospitals are more at risk for getting overwhelmed.”
For now, Bay Area hospitals say they have enough to meet demand. To expand supplies, they are seeking other routes to obtain the drug, such as enrolling eligible patients in Gilead’s clinical trials.
Within a county, there is daily communication about hospitals’ needs, said Camille Camargo Kamboj, director of pharmacy at Regional Medical Center in San Jose.
Every morning before 10 a.m., the hospital reports
to Santa Clara County the number of vials that it has, she said. “This allows them to know how many unused vials the county has and then reallocate it to the hospitals that need it most.”
In Contra Costa County, hospitals have shared extra doses with each other, so all eligible patients got the drug. But that might not be the case going forward, as allocations are expected to be smaller, said spokesman Will Harper.
In Alameda County, a distribution framework has been developed by 40 medical and pharmaceutical experts from every acute hospital and the county’s health officials. Hospitals receive a number of doses proportional to their number of eligible patients, based on availability of the drug.
San Francisco’s guidance has been very clear: “Don’t hoard this,” said San Francisco General Hospital’s Luetkemeyer. “And if we have enough and somebody else didn’t, we would share our drug. And they would likely share with us.”