Medical Groups Call for Transparency in Federal Distribution of Remdesivir

How the federal government is handling the distribution of Gilead’s remdesivir for treatment of COVID-19 patients is sparking outrage and sharp criticism from physicians’ groups and doctors across the nation.

One physician in Boston noted this week that his hospital did not receive any remdesivir despite having the second-highest absolute COVID-19 case count in the city.

“Today, the family of a dying patient asked me why we do not have [remdesivir], what am I supposed to say?” Benjamin Linas, a physician at the Boston Medical Center, asked on Twitter.

Katy Stephenson, a physician in Massachusetts, also questioned the process on Twitter, asking if experts or political appointees are determining who gets the drug, and if the process will be transparent.

“Right now, there is not a lot of trust in our federal response,” she wrote. “Like I said, remdesivir is our first test case. It is precedent for vaccines, antibodies and everything to come.”

Melanie Thompson, a physician in Georgia, asked on Twitter why five different healthcare centers in Georgia did not receive remdesivir, noting that they are “key sites — and hot spots — for COVID-19 treatment.”

Peter Chin-Hong, an infectious disease doctor at the University of California-San Francisco, posted a map to his Twitter feed that showed only 25 hospitals across the country being cleared receive the drug.

In an open letter to Vice President Mike Pence, the Infectious Disease Society of America and HIV Medicine Association said they don’t believe the Trump administration is doing all it can to ensure that the distribution is fair and transparent.

The organizations — which represent more than 12,000 infectious disease and HIV physicians, scientists and other public health professionals — urged Pence, who currently leads the administration’s coronavirus taskforce, to base distribution on state and regional COVID-19 case data and hospitalization rates.

“Supplies of remdesivir should be distributed on a regional basis with equitable distribution within the region to states and within states to hospitals,” the groups said, adding that data on the distribution of remdesivir under the FDA’s Emergency Use Authorization (EUA) should be publicly available.

HHS, which is overseeing the drug’s distribution, did not return calls for comment Thursday.

The physicians’ groups also called for data from the National Institutes of Health’s Adaptive COVID-19 Treatment Trial to be publicly released so that hospitals with a limited supply “have the best possible data to inform how to distribute it among patients.” That trial is ongoing and is evaluating remdesivir in combination with other drugs for the treatment of COVID-19.

The EUA application required for each patient should be streamlined to require only the minimum amount of data and information required to consider the request, the groups said.

Meanwhile, Gilead is still making its own donations of the drug to some states. Maryland’s Gov. Larry Hogan announced that Gilead is donating 1,600 doses of remdesivir for distribution to hospitals across his state. The initial doses will go to Prince George’s and Montgomery counties, which have the state’s highest concentration of cases.

Also this week, Japan approved Gilead’s remdesivir for treatment of COVID-19, making it the first country to officially approve the antiviral drug for the coronavirus.

Gilead filed for fast-track approval of the drug on Monday in Japan, just days after the FDA granted remdesivir an EUA for severe COVID-19 patients in the U.S. Japan’s approval referenced the EUA issued by the FDA.

Japanese health officials said the drug will be given to patients with severe COVID-19 symptoms.

Read the May 6 letter to Vice President Pence here: www.fdanews.com/05-07-20-remdesivireualetter.pdf. — Jordan Williams