GILD Gilead Sciences Inc

By Stephanie Armour and Joseph Walker 

Health-care leaders are expressing concern over how the Trump administration plans to distribute the promising coronavirus drug remdesivir, saying they are in the dark about the allocation criteria being used and are worried it isn't based on need.

Some hospital officials say they have been informed they can't get the drug since the federal government took over its allocation following the Food and Drug Administration's emergency use authorization on May 1.

"Patients are going to die if we can't get access," said Dr. Amy Compton-Phillips, chief clinical officer at Providence St. Joseph Health in Seattle. "We need transparency on who is getting remdesivir."

That lack of clarity surrounding the drug's allocation is prompting health-care professionals to question whether remdesivir is being distributed based on need or other considerations.

Providence Health was involved in national clinical trials to test remdesivir in patients with severe and moderate Covid-19, the disease caused by the new coronavirus. Officials there now say they can no longer get the drug for patients because they haven't been selected by the government to receive it.

Health and Human Services and the Federal Emergency Management Agency, which are handling allocation, didn't immediately return emails seeking comment.

"We have sick patients now," said Dr. Michael G. Ison, at Northwestern University Feinberg School of Medicine in Chicago, adding that they can't get the drug. "It's a mess. The critical issue is that there has been a plan put in place and no clarity put in place."

Gilead Sciences Inc., which developed remdesivir, has pledged to donate 1.5 million doses -- or enough to treat up to about 190,000 patients -- that it expects to manufacture by the end of this month. Supply of the drug is limited, and some analysts predict shortages relative to demand this summer. Gilead says it aims to produce enough remdesivir to treat more than one million patients by the end of 2020.

After receiving emergency use authorization, the company said it isn't playing a role in deciding how to allocate the donated supply of the drug in the U.S.

"Gilead is not deciding which hospitals will receive remdesivir," a Gilead spokesman said in an email on Thursday. Because remdesivir has only been shown to be effective in severely sick patients, and is in short supply, "hospitals with intensive care units and other hospitals that the government deems most in need will receive priority in the distribution of remdesivir."

The University of California San Francisco's hospital system learned this week that it wasn't chosen to receive the drug after calling AmerisourceBergen Corp., says Peter Chin-Hong, an infectious-disease specialist and professor of medicine at the university. Dr. Chin-Hong says his hospital, UCSF Medical Center, typically has around 20 Covid-19 patients receiving inpatient treatment, including those referred from local hospitals.

Amerisource, a drug wholesaler, is the exclusive distributor of remdesivir, according to Gilead.

At the moment, UCSF doesn't have patients who it would like to treat with remdesivir but can't, but Dr. Chin-Hong worries that could change quickly. "It's just the uncertainty," says Dr. Chin-Hong. "We've been blessed to have it, but the well is going to run out soon and we don't know when it's going to rain again."

Dr. Chin-Hong and his colleagues have been surveying doctors at hospitals around the U.S. caring for Covid-19 patients on whether they've been selected to receive the drug and posting the results online.

So far about 25 hospitals asked have said they were selected, Dr. Chin-Hong says.

UCSF still has a supply of remdesivir for patients in a so-called expanded access program that allows the drug to be used by very sick patients on ventilators who aren't eligible for clinical trials. Gilead set up the program before the FDA's emergency authorization, and was diligent in supplying the drug for those patients, Dr. Chin-Hong says.

This week, a Gilead contractor told UCSF that it could only use that supply for patients enrolled in the expanded access program, and that any drug left over would have to be destroyed, Dr. Chin-Hong says. The instructions were logical from a regulatory perspective, he says, but were surprising at a time when "this drug is treated like gold."

Gilead didn't respond to a request for comment.

The National Institute of Allergy and Infectious Diseases said that a preliminary analysis of its study showed that hospitalized Covid-19 patients taking remdesivir had a speedier recovery than patients taking a placebo -- though the reported benefit was moderate, with remdesivir patients recovering in 11 days, or four days faster than the placebo group.

In an emailed statement, an Amerisource spokesman said "decisions on which hospitals and the quantity of the product they will receive are being made by the government," and Amerisource is working to "move any product we receive from Gilead in keeping with the government's directives."

Amerisource is distributing remdesivir to hospitals across the U.S. "regardless of whether they are AmerisourceBergen customers," the spokesman said. Hospitals designated by the U.S. government to receive donated remdesivir will be contacted directly by Amerisource, according to a notice on the company's website.

"From what we can tell, it's not based on need," said Helen Boucher, division of geographic medicine and infectious diseases chief at Tufts Medical Center. She said information on the clinical trial also needs to be shared by the federal government to help guide medical decisions.

The plan for distributing remdesivir should be transparent and based on state and regional case data and hospitalization rates, according to a letter sent Thursday to Vice President Mike Pence from the Infectious Diseases Society of America and the HIV Medicine Association.

The groups, which represent over 12,000 infectious diseases and HIV physicians, scientists, and others, said allocation should be on a regional basis that's equitable within the region to states and within states to hospitals.

This will be imperative to ensure appropriate patient access and "reduce the significant health disparities and adverse outcomes already experienced by Black Americans, Latinx communities and other populations, " the letter says.

Write to Stephanie Armour at stephanie.armour@wsj.com and Joseph Walker at joseph.walker@wsj.com

(END) Dow Jones Newswires

May 07, 2020 19:29 ET (23:29 GMT)

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