The distribution of a promising drug by the federal government to hospitals with COVID-19 patients has raised hackles among medical professionals after UCSF and many other medical centers with critical patients weren’t given a single dose.
The experimental drug, remdesivir, reduced coronavirus symptoms in clinical trials and was approved last week by the U.S. Food and Drug Administration under what is called an emergency use authorization, but only two of the 25 medical centers that got the drug were in California.
Pharmacists at UCSF were shocked when they learned this week that they would not be getting any of the 1.5 million doses in the initial distribution. It was a particularly hard blow because UCSF was one of five sites in the country where clinical trials of the drug were conducted.
The UCSF system, which includes six medical centers throughout California, is also in close proximity to remdesivir’s manufacturer, Gilead Sciences, headquartered in Foster City.
Peter Chin-Hong, a professor of medicine and an infectious disease expert at UCSF, said a lack of information about the decision-making process has caused widespread fear that the Trump administration is deciding who gets what based on politics, not medical need.
“We are worried because we saw there were delays in the distribution of other things, like testing, masks and swabs,” Chin-Hong said. “I’m hoping this is just the beginning and that we will eventually get some, but I’m worried about speed as well because, in an epidemic waiting means lives lost.”
The UCSF medical staff isn’t alone in its concern. Hospitals and physicians around the country have criticized the government for a lack of transparency about which hospitals are getting supplies, the method that is being used to choose them and even which federal agency or official is making those decisions.
Gilead CEO Daniel O’Day said Sunday that the company would donate treatment courses for as many as 200,000 patients, or 1.5 million vials. The company is ramping up production, so more is likely to be available in the future.
Gilead officials said the Federal Emergency Management Agency and the U.S. Department of Health and Human Services are in charge of distributing the drug to hospitals in areas most affected by the pandemic.
“Given the severity of illness of patients appropriate for remdesivir treatment and the limited availability of drug supply, hospitals with intensive care units and other hospitals that the government deems most in need will receive priority in the distribution of remdesivir,” Chris Ridley, the Gilead spokesman, said in an email.
FEMA officials referred inquiries to Health and Human Services, which did not respond to requests for comment.
The government hired AmerisourceBergen, of Chesterbrook, Pa., to deliver the supplies. Spokesman Gabe Weissman said in an email that the distributor is “working closely” with Gilead and federal officials to provide the drug to hospitals across the nation, but he declined to provide specifics about how the drug is being distributed or whether any California hospitals would receive it.
The U.S. government has not released a list of which hospitals will be getting supplies, but Conan MacDougall, a clinical pharmacy professor at UCSF, compiled a list after making inquiries at other hospitals and created a map of centers approved and denied.
Most of the available supply of remdesivir appears to be going to COVID-19 hot spots on the East Coast, with one large hospital in Nashville receiving a supply.
The map shows two approvals at medical centers in California, one in the city of San Mateo and one in Los Angeles, but it does not specify which hospitals.
Still, Chin-Hong and his colleagues said there is no logical reason to bypass the UCSF health system, which, besides its San Francisco medical center, includes health centers at UC Davis, UCLA, UC San Diego, UC Irvine and UC Riverside. It is the fourth-largest health delivery system in California.
“Just because we are not in a surge mode like the East Coast doesn’t mean we do not have critical patients who are in need,” said Katherine Yang, a professor in the department of clinical pharmacy. “UCSF also serves an incredibly diverse population, many who are at higher risk for COVID disease. The way to improve patient outcome is to remove barriers, increase access and provide faster access. This is what we need.”
Chin-Hong said things went much more smoothly and efficiently in 2009 during the H1N1 flu outbreak. At that time, the Centers for Disease Control and Prevention created a website and facilitated distribution of the drug peramivir whenever it was needed.
Many hospitals can still get remdesivir through the Gilead Expanded Access Program, but that program has strict criteria and requires the patient to be seriously ill. The problem is that antivirals like remdesivir work better earlier in the disease. The emergency authorization allows doctors to administer the drug during the early stages.
The Infectious Diseases Society of America and the HIV Medicine Association wrote a letter this week urging the federal government to ensure a fair and equitable distribution of remdesivir and to make that information publicly available.
Originally conceived as a treatment for Ebola, remdesivir is an antiviral drug that interferes with the way viruses replicate. It shortened the time it took patients to recover in two COVID-19 trials, including an international study of more than 1,000 hospitalized patients sponsored by the U.S. government.
The federally sponsored trial found in early results that patients who received remdesivir recovered 31% faster than patients who received a placebo.
Separately, a Gilead clinical trial of nearly 400 patients with severe symptoms found that patients who received the drug earlier fared better than those who got it later.