Washington – Federal approval of the drug remdesivir to treat COVID-19 does not mean everyone will have access to it. It is in short supply in Connecticut and other “hot spots” struggling with the coronavirus.
Who will ultimately have access to remdesivir, or any of the dozens of other drugs in trials aimed at finding effective treatments for COVID-19, is a question being raised by doctors and lawmakers, including Rep. Rosa DeLauro, D-3rd District. They are concerned about both access and affordability.
“In a perfect world remdesivir would be available to everyone who meets the prescribing qualifications, but there’s very likely to be a shortage,” said Alison Bateman-House, a professor of medical ethics New York University’s Grossman School of Medicine.
In the case of remdesivir, currently the only drug known to curb – but not cure – the assault of coronavirus on a human body, the federal government is setting guidelines as to who can be treated and which hospitals will have access to the drug outside of continuing research trials.
About two dozen hospitals are believed to have been chosen to receive the drug so far. But it is unclear why some medical centers were chosen to receive the coveted drug while others weren’t — and who is making decisions about the drug’s distribution.
The Food and Drug Administration and the Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response did not return repeated requests for information about the drug’s distribution.
“I have fears, given the personal protection equipment and ventilator differential being distributed in accordance with political calculations, that this will happen with remdesivir, too,” Bateman-House said.
Last week the FDA set guidelines allowing remdesivir to be given to patients with COVID-19 only if they are severely ill — with blood oxygen levels at 94% or lower, or otherwise requiring supplemental oxygen.
Only days before, on April 29, the National Institute of Allergy and Infectious Diseases, or NIAID, the agency headed by Dr. Anthony Fauci, announced that a National Institute of Health trial showed remdesivir treatment led to faster recovery in hospital patients with COVID-19, compared with placebo treatment.
Specifically, the median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received placebo,” a NIAID press release said.
The FDA authorized emergency use of the drug on May 1.
But the supply of the drug, produced by Gilead Sciences Inc., is limited, given remdesivir is a complex intravenous medication and its maker must provide enough of it to support the clinical trials being conducted at nearly 200 sites across the globe. The antiviral drug, a medicine first developed to treat Ebola with disappointing results, is still considered experimental.
The Yale New Haven Health System has 50 patients on remdesivir because it is one of dozens of sites conducting the ongoing clinical trial of the drug. But the health system, the largest in Connecticut, was advised Wednesday it would not receive any remdesivir to be used on patients outside those involved in the trial.
“It was very disappointing to hear. It’s not good news for us,” said Leeann Miller, vice president and chief pharmacy officer at Yale New Haven Health. “We have absolutely no information as to how the decision was made.”
University of Connecticut Health was about to begin a trial of remdesivir when it was stopped. So it never received any vials of the drug for the trial. UConn Health does not know if it is on the list of those who will be able to use the drug on patients with COVID-19.
“We don’t know if we are going to get it or not,” said hospital spokeswoman Jennifer Walker. “The hope is we do.”
On Monday, UConn Health received a letter from Gilead that said that since the FDA had issued emergency use authorization, or EUA, for remdesivir, the drug company would not be activating additional clinical trial sites.
“The U.S. government will coordinate the distribution of remdesivir to hospitals,” Gilead said. “While Gilead does not have any control over the hospitals that will receive remdesivir under the EUA, we have provided to the government a list of all hospitals that were selected to participate in our expanded access protocol.”
Gilead also said if a hospital is on the list to receive the drug, it would be contacted by the exclusive distributor of the antiviral, AmerisourceBergen. Neither Gilead or AmerisourceBergen responded to requests for information.
Scrambling for remdesivir
One of Bateman-House’s duties at NYU is the monitoring drug trials to make sure they are conducted safely and that the data is not compromised.
She said Gilead was able to win approval of emergency use for remdesivir at an “incredibly rapid pace, compared to the glacial pace of approval” of other drugs approved for emergency purposes by the FDA.
Since “everybody is going to be scrambling to get remdesivir,” Bateman-House said, medical professionals should target its use at those likely to benefit most. That would be patients in the latter stages of the disease “who show signs they would not be getting better any time soon,” she said.
Lydia Dugdale, director of the Center for Clinical Medical Ethics at Columbia University, said the drug, while no “magic bullet” and no cure for COVID-19, has shown to be effective in speeding recovery in very ill patients. “At this point the drug will likely continue to be prioritized for the sickest patients, which, as it happens, disproportionately represent racial and ethnic minorities in the United States,” Dugdale said.
How much will it cost?
Others are not as optimistic, and concerned remdesivir will carry a high price tag when it is available to all on the market.
Gilead’s history of sky high drug pricing is drawing increasing scrutiny from Congress about how much it will charge for remdesivir and who will get access. The drug maker suffered a spate of bad publicity in 2015 for charging $84,000 for a hepatitis C drug, and is under pressure from Wall Street investors to recoup their $1 billion investment in remdesivir.
Calculating the cost of development and trials, the Institute for Clinical and Economic Review says the drug could cost from a few hundred dollars to $4,500 for a 10-day course of treatment. But Wall Street analysts say the drug prices should be higher.
“An unaffordable drug is completely ineffective,” DeLauro and Lloyd Doggett, D-Texas, wrote to Health and Human Services Secretary Alex Azar last week in a letter raising questions about remdesivir.
The Democrats asked Azar to release information about the extent of taxpayer investment in remdesivir, government ownership of any remdesivir patents, and any federal efforts to scale up production. They said “substantial taxpayer investments in COVID-19 pharmaceutical research must be recognized.”
The lawmakers said that, before the coronavirus pandemic, NIH spent nearly $700 million on coronavirus research and since the virus appeared in the United States, Congress has appropriated over $6.5 billion for the research and development of therapeutics and vaccines.
“Remdesivir’s preliminary clinical trial data is encouraging, and those who fall ill from COVID-19 deserve to be able to access it,” DeLauro said. “A full accounting of our federal investment will help prevent price gouging, so I encourage Secretary Azar to follow through on our request as expeditiously as possible.”
Azar, however, has not responded to the Democratic lawmakers.
“Unfortunately, this is one of several letters I have sent to [the Department of Health and Human Services] during this pandemic that has gone unanswered,” DeLauro said. “Congressional oversight is critical to holding the administration accountable to the needs of the American people,” she said, ” —especially since I chair the Appropriations Subcommittee that funds the specific agencies and programs outlined.
“The Trump administration needs to be responsive to our requests,” DeLauro said.
Dugdale, however, said all drugs have taxpayer investment.
“Most drug development is funded, at least in part, by the federal government in its early stage,” Dugdale said. “On this point, remdesivir is no different.”