Updated 4:15 p.m.
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The Food and Drug Administration issued an emergency use authorization on May 1 for the drug remdesivir in the treatment of severely ill COVID-19 patients. Most hospitals nationwide have been struggling to get it ever since.
Last week, preliminary trial results of the drug showed it can help hospitalized patients recover faster. The full results have yet to be published in a peer-reviewed journal. But now that there is clear evidence the drug works, researchers have an ethical responsibility to not give patients in trials placebos.
Remdesivir doesn’t kill the novel coronavirus — it just interrupts the process by which the virus makes more copies of itself, thus limiting the spread, according to David Mihalic, director of pharmacy at Einstein Medical Center Montgomery. Remdesivir was once studied for Ebola, and has not been approved by the FDA to treat anything.
The drugmaker Gilead has 1.5 million doses of remdesivir, enough for about 140,000 patients. The United States has more than 1.2 million COVID-19 cases, according to the Centers for Disease Control and Prevention.
Gilead has donated its existing supply, to be distributed by Chesterbrook, Pennsylvania-based pharmaceuticals services firm AmerisourceBergen. That company has said the U.S. government decides which places and hospitals can get the drug.
Gilead, in a statement on its website, says that it is talking to drugmakers around the world to look into making more supplies of remdesivir.
On Saturday, the U.S. Department of Health and Human Services announced in a statement that six states hard hit by the coronavirus would be getting quantities of the remdesivir donated by Gilead: New Jersey (110 cases), Connecticut (30 cases), Illinois (140 cases), Iowa (10 cases), Maryland (30 cases), and Michigan (40 cases). Each case contains 40 vials of the donated drug.
The HHS statement said seven states, including New Jersey (94 cases), had gotten an initial allocation earlier this week: New York (565 cases), Indiana (38), Massachusetts (117), Rhode Island (30), Tennessee (7) and Virginia (33).
David Showalter, system director for pharmacy service at Main Line Health, said the situation has left hospitals with many questions.
“What’s even more confusing and a little frustrating is that the government hasn’t really issued … what their inclusion criteria is for distributing remdesivir,” Showalter said. “Every possible channel that I have to get the drug, I am working: I am pleading, I am emailing, I am calling multiple days, I escalated to the CEO [of Main Line Health].”
He said he just wants to know how the federal government is deciding which places can get the drug and why, so he can explain that to the doctors, patients, and family members asking for it. A Pennsylvania Department of Health representative said the states have not been told either.
Apparently the Remdesivir has been distributed. @the_bmc got none. We have the second highest absolute case count and highest per bed in Boston. We also had no access to early trials. Today, the family of a dying patient asked me why we do not have RDV. What am I supposed to say?
— Benjamin P. Linas (@BenjaminLinas) May 6, 2020
Christine Roussel, director of pharmacy at Doylestown Hospital and president of the Pennsylvania Society of Health System Pharmacists, said the confusion takes a toll on patients, doctors and pharmacists.
“Patients’ families are desperate … and it’s heartbreaking for us as clinicians not to be able to give them drugs that we want to,” she said. “This [past] weekend, I would say my communication about remdesivir from doctors, research, pharmacy leadership, colleagues … I had at least 100 plus emails just on remdesivir, and many phone calls.”
Roussel said pharmacists have suffered with drug shortages for the past few years and it’s taken an emotional toll.
“I woke up the other night screaming in my bed because I was going to buy fentanyl in my dream and ended up in an alleyway and got assaulted … it’s awful,” Roussel said.
But this situation is even worse, she said.
A professor of clinical pharmacy at the University of California, San Francisco surveyed pharmacists and pharmacy groups nationwide to make a map of which places got remdesivir — they included locations in California, New York, Tennessee, Connecticut and Massachusetts.
According to the map, no place in Pennsylvania or Delaware had gotten any doses under the FDA’s emergency use authorization. Temple Health and Jefferson Health are sites for ongoing clinical trials for remdesivir, but they have not gotten more of the drug either.
The American Society of Health-System Pharmacists, the Infectious Diseases Society of America, and the HIV Medicine Association have written open letters to Vice President Mike Pence asking for transparency about how the government decides who can get remdesivir, and any other COVID-19 treatments and vaccines.
U.S. Rep. Brian Fitzpatrick, R-Pa., who represents Bucks County and parts of Montgomery County, has written a similar letter to the Secretary of Health and Human Services.
Editor’s note: This article was updated to include new Department of Health and Human Services details about allocations of remdesivir to several states, including New Jersey.