How does the government decide who gets remdesivir? Doctors have no idea

Remdesivir is the only drug shown to be effective against Covid-19 in a rigorous trial. But the drug's maker, Gilead Sciences, says there's only enough of it in the world for about 200,000 patients. CNN's Elizabeth Cohen reports.

Posted: May 9, 2020 7:11 PM
Updated: May 9, 2020 7:11 PM

It's the first and only drug shown to be effective against the novel coronavirus in a rigorous trial. Its effects are modest but significant -- shortening a patient's hospital stay by about four days. Dr. Anthony Fauci, the nation's top infectious disease specialist, has called it the new "standard of care" for Covid-19.

But as it stands now, there's only enough remdesivir in the world for about 200,000 patients, according to the drug's maker, Gilead Sciences. Who will those patients be?

The US government, which is deciding where remdesivir goes, has offered few answers and little guidance since the drug was authorized for use on hospitalized patients a week ago.

No comprehensive plan for distribution has been publicly released in the days since. But doctors and pharmacists on the front lines tell CNN that the process for accessing the drug has been opaque.

"Will we get it? Yes, no? What's the speed at which we're going to get it? Every day that you delay getting the drug to a particular hospital or a community means lives lost," said Dr. Peter Chin-Hong, a professor of medicine at the University of California, San Francisco School of Medicine.

As of now, there appears to be no way to apply for remdesivir, according to six doctors and pharmacists who spoke to CNN. Chin-Hong said one colleague described the process as: "Don't call us, we'll call you."

Asked about the plan on Sunday, the US Department of Health and Human Services told CNN to contact the Federal Emergency Management Agency, which said the drug would be distributed "based on an allocation plan approved by the White House Task Force."

But asked for an update on Wednesday, FEMA directed CNN back to HHS, saying that agency would be handling the drug's distribution. HHS and the White House task force, for their part, did not respond to CNN's requests for comment.

AmerisourceBergen, the distributor for remdesivir in the United States, offers a vague explanation on its website: "If you are a hospital identified by the U.S. government as a recipient for donated remdesivir, you will be proactively contacted by an AmerisourceBergen representative."

That donation refers to 1.5 million vials of remdesivir that Daniel O'Day, Gilead's CEO, has said the company is providing to the US government to allocate -- enough for between 100,000 and 200,000 treatment courses.

But O'Day has also said the company plans to distribute that donation globally. Asked for clarification last weekend, Gilead spokesperson Sonia Choi told CNN: "We are working with regulatory authorities worldwide and bioethicists to help inform our global allocation approach."

'You're going to breed a huge backlash'

"If you had to boil it down, the one thing that I'm concerned about is just lack of transparency," said Chin-Hong.

He said he has discussed remdesivir access with doctors around the country, "and I think the pervasive feeling that I would say everyone in this group has is anxiety. And that's because of lack of transparency."

Doctors understand that there is a limited supply of the drug and that resources need to be rationed, Chin-Hong said. "But there's no process, there's no way to go and look something up when you want to advocate for your own hospital or advocate for your own community."

CNN medical analyst Arthur Caplan, founding head of the Division of Medical Ethics at the New York University School of Medicine, has studied these issues before. "One thing we know about rationing is people will accept it if they understand the rationale," he said.

"But when you ration and you don't explain what you're doing, when you're not transparent, when you don't make any effort to explain who's getting something and who isn't -- particularly in a time when panic is everywhere with respect to trying to treat people who are ill with [Covid-19] -- then you're going to breed a huge backlash, which is what you're seeing."

The frustration from doctors is one thing, Caplan said, but anger from patients and their families is likely to come too if they aren't able to access the drug -- and don't understand why.

"This morning I wake up to realize that drug was promised to a handful of hospitals with no obvious criteria," said Dr. Nicole Theodoropoulos, an associate professor at the University of Massachusetts Medical School, on Thursday. "It's difficult to know what to tell patients when there is no transparency about the process."

Gilead Sciences has not responded to CNN's request for comment, although the company has said that "tens of thousands" of courses of remdesivir would begin shipping out this week. The company has set a goal of producing more than a million courses by December.

In a statement, AmerisourceBergen, the drug's distributor, said: "Decisions on which hospitals and the quantity of the product they will receive are being made by the government with AmerisourceBergen using our infrastructure and expertise to efficiently move any product we receive from Gilead in keeping with the government's directives."

The FDA-authorized drug is infused through an IV, and its use is limited to hospitalized patients with severe disease. But Daniel O'Day, chairman and CEO of Gilead Sciences, has said Gilead is looking at other formulations of remdesivir too -- including an inhaled version that could be given outside of the hospital.

'No one knows how to advocate for your hospital'

"I think people are frustrated," said Dr. Michael Ison, a professor of infectious diseases at the Northwestern University Feinberg School of Medicine.

"We've got patients that are sick and dying from Covid-19. We want to give them the best possible therapy and we don't have access to it. We don't know how to get access to it. No one knows how to advocate for your hospital to have this drug made available to your patients."

He described the delicate balancing act that doctors have to navigate: "If we know we're going to get [remdesivir] for patients, we may hold off on giving other therapies because we know we're going to be getting this therapy that we can offer them instead."

The frustration, he said, is that "we have no idea what the process has been to be selected." The only way to get a glimpse into where the drug is going, he said, is through an ad hoc website put together by researchers at UCSF.

"I've collated an unofficial list of hospitals who are and are not currently slated to receive the drug through a survey of pharmacists and physicians," said Conan MacDougall, a professor of clinical pharmacy at the UCSF School of Pharmacy.

Some major medical centers may be able to provide remdesivir to patients under existing research programs, MacDougall said, but not all patients are eligible for those.

Clinical trials and so-called expanded access programs, which have long been available, can have stringent criteria. And when the US Food and Drug Administration issued an emergency use authorization for remdesivir last week, it framed the move as a way to increase access to the drug.

The FDA issued a similar emergency authorization during the H1N1 pandemic for another antiviral medicine, peramivir. But back then, the US Centers for Disease Control and Prevention was responsible for managing the drug's distribution. As described in The New England Journal of Medicine in 2009, the CDC created an online portal for physicians to request the drug at a time when just 1,200 treatment courses were available.

To patients who won't get the drug, 'you can't even explain why'

Like others CNN spoke to, Dr. Cameron Wolfe, an associate professor of medicine at the Duke University School of Medicine, said he understands that limited supplies need to be distributed across the country.

"It's one thing to say, well, we just don't have enough, and it's going to cities that are being heavily hit. I think most families would understand that. It's a hard call, but I think they would understand why."

With no idea of how drugs are being rationed, though, "I can't even say that. I can't even look my colleague in the face and say I know why we are not getting access to this drug.

"That makes for difficult conversations. That makes for painful conversations. And it just doesn't allow you to plan from a hospital point of view."

On Wednesday, the Infectious Diseases Society of America and the HIV Medicine Association wrote a joint letter to Vice President Mike Pence, urging the federal government to ensure the "fair and equitable distribution of remdesivir."

The plan for allocating the drug, they said, should be based on evidence about the virus' spread. "Data on the distribution of remdesivir under the [emergency uses authorization] should be publicly available," they added.

Indiana Coronavirus Cases

Data is updated nightly.

Cases: 768624

Reported Deaths: 13993
CountyCasesDeaths
Marion1055891807
Lake569801031
Allen43032699
St. Joseph37344568
Hamilton37335426
Elkhart29783470
Tippecanoe23503230
Vanderburgh23240405
Porter19580327
Johnson18843392
Hendricks18089323
Madison13575347
Clark13552198
Vigo12869256
LaPorte12578225
Monroe12575178
Delaware11155198
Howard10693237
Kosciusko9792124
Hancock8761150
Bartholomew8274157
Warrick8084157
Floyd8043182
Grant7378181
Wayne7239201
Boone7211105
Morgan6924143
Marshall6345117
Dubois6283118
Cass6096112
Dearborn602178
Noble600890
Henry5958111
Jackson517277
Shelby511598
Lawrence4928127
Gibson463696
Montgomery459292
DeKalb456785
Clinton456055
Harrison454077
Huntington417882
Whitley416745
Steuben411260
Miami406073
Jasper401655
Knox388691
Putnam385762
Wabash370384
Adams353856
Ripley351971
Jefferson343487
White340154
Daviess3089100
Wells304081
Greene295185
Decatur292693
Fayette286564
Posey282635
Scott281058
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Clay274949
Washington254637
Randolph247783
Jennings239749
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Starke229959
Owen222959
Sullivan221643
Fulton208945
Jay203032
Carroll197722
Orange191756
Perry189939
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Tipton173347
Franklin172535
Parke155916
Pike142534
Blackford138032
Pulaski123748
Newton123336
Benton109715
Brown106243
Crawford105816
Martin92515
Warren87915
Switzerland8378
Union73610
Ohio58411
Unassigned0429

Ohio Coronavirus Cases

Data is updated nightly.

Cases: 1125420

Reported Deaths: 20490
CountyCasesDeaths
Franklin1305631493
Cuyahoga1173952263
Hamilton825481261
Montgomery536581062
Summit489381014
Lucas43799834
Butler40064614
Stark33876939
Lorain26072510
Warren24959312
Mahoning22738613
Lake21482396
Clermont20425261
Delaware19169138
Licking16879227
Trumbull16829492
Fairfield16825207
Medina15880276
Greene15565254
Clark14366308
Portage13450218
Wood13358201
Allen12064245
Richland11748213
Miami11047228
Wayne9275228
Columbiana9216236
Muskingum9144137
Pickaway8755123
Tuscarawas8724255
Marion8716140
Erie8146166
Ashtabula7280179
Hancock7050135
Ross7031165
Geauga6975153
Scioto6726108
Belmont6224179
Lawrence5964104
Union591649
Jefferson5729162
Huron5644122
Sandusky5498130
Darke5448131
Seneca5380128
Washington5373111
Athens527260
Auglaize507787
Mercer491785
Shelby484397
Knox4621113
Madison448066
Ashland446198
Defiance439499
Fulton436875
Putnam4358104
Crawford4120111
Brown410462
Preble3956107
Logan392279
Clinton391466
Ottawa376481
Highland366668
Williams357378
Champaign349860
Guernsey331554
Jackson321954
Perry299050
Morrow294943
Fayette289350
Hardin279665
Henry277467
Coshocton273061
Holmes2726102
Van Wert252365
Gallia251150
Adams250958
Pike244837
Wyandot235557
Hocking222963
Carroll201449
Paulding180142
Meigs151540
Monroe137945
Noble137939
Harrison115438
Morgan111724
Vinton87517
Unassigned04
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