UM health system denied doses of COVID-19 drug remdesivir
Michigan Medicine, the University of Michigan health system, this week was denied doses of the antiviral medicine remdesivir after requesting it for COVID-19 patients, officials said.
The rejection came as doctors and hospitals nationwide expressed frustration with the federal distribution of the country’s limited stock of remdesivir, the only drug approved to treat the illness COVID-19.
After physicians and pharmacists raised questions about access to the drug, the Trump administration over the weekend said it was sending doses to Michigan and five other states to be distributed by state health departments.
But officials have not publicly disclosed the criteria for determining which medical centers got the initial doses of the drug, and physicians called that allocation uneven and confusing.
Dr. Daniel Kaul, an infectious disease specialist at Michigan Medicine, criticized the lack of transparency about how the initial allocations were made and what federal agency was making the decisions, saying there has been "essentially no communication whatsoever."
He communicated this week with a group of other infectious disease doctors and learned some hospitals had received doses that had no COVID cases, while major medical centers with COVID-positive patients in hard-hit areas were not on the approved list to receive the drug.
"We started to wonder, what is going on here? This isn't making sense to us," Kaul said.
Michigan Medicine had treated 440 COVID patients and as of Friday had 76 COVID inpatients, down from a high of 229 on April 15.
The state of Michigan has been among the hardest hit by the pandemic, with over 4,500 deaths — the fourth most of any U.S. state.
The Food and Drug Administration on May 1 granted emergency approval for remdesivir after a federal clinical trial showed it to be effective. The drug’s manufacturer, Gilead Sciences, then announced it would donate its existing supply — 1.5 million doses.
Kaul said his pharmacy colleagues informed him Wednesday they wouldn't receive any doses of remdesivir after hearing from the drug's private distributor that they weren't on the government's list of medical centers approved to receive the drug.
"There is absolutely no reason that I can think of for these decisions to be anything but medical and scientific," Kaul said.
"All I know is that it appeared completely random, where small hospitals — some of whom didn't even have COVID patients — were receiving supplies."
He noted that Massachusetts General Hospital got a supply that it then donated to the state health department, so it could be distributed in an equitable way.
"Especially with a disease like this where there are huge differences in how badly this is impacting communities based on socio-economic status, that it's just critical that there is transparency and equity around how this scarce resource is distributed," Kaul said.
"I'm not saying Michigan Medicine should have priority. I'm just saying there should be a transparent process with clear criteria and clear communication about where the drug is available," Kaul added.
The Infectious Diseases Society of America on Thursday recommended distributions to states and hospitals based on COVID-19 case and hospitalization rates.
After the alarm raised by the medical community, the White House on Friday said Dr. Deborah L. Birx, the coordinator of the White House Coronavirus Task Force, would be one of the "chief consultants" on how the drug would be distributed.
"She is going to be working and consulting as to where this drug should go," White House Press Secretary Kayleigh McEnany said. “She really has the best grasp as to how that should be distributed."
By Saturday afternoon, the U.S. Department of Health and Human Services announced that Michigan would receive 40 cases of the drug, with each case containing 40 single-dose vials for a total 1,600 doses, as part of an allocation to hard-hit areas.
The Michigan Department of Health and Human Services said later Saturday that it received the 40 cases and was developing an allocation strategy for its distribution to hospitals, spokesman Bob Wheaton said.
The 1,600 vials represent 145 patient courses, based on a 10-day course, Wheaton said.
U.S. Reps. Fred Upton, R-St. Joseph, and Debbie Dingell, D-Dearborn, had written Friday to the U.S. Department of Health and Human Services seeking information about the process and criteria initially used to distribute remdesivir, as well as data on which hospitals got it and in what amounts.
“Currently, hospitals and providers, including those in the State of Michigan, have been denied access to the drug without explanation," the lawmakers wrote.
"Clarity on the criteria used for distribution will allow providers to more effectively manage treatment of COVID-19 patients in the coming days and weeks."
Upton’s office didn’t know of any Michigan hospitals that had received doses, a spokesman said.
“It’s deeply concerning that a leading medical research and provider such as Michigan Medicine was denied doses of remdesivir by the administration,” Dingell said.
In a statement to WBUR in Boston, the Federal Emergency Management Agency said the initial allocation of the drug was made to seven states Tuesday, and going forward federal HHS would be managing distribution of the next "tranche" of the treatment "based on urgent need."
The drug’s distributor, AmerisourceBergen, posted on its website that hospitals with intensive care units and hospitals that “the U.S. government deems most in need" will receive priority in the distribution of remdesivir, with the government coordinating the distribution to regions "most heavily impacted by COVID-19."
The website also said “neither Gilead nor AmerisourceBergen are deciding which hospitals will receive remdesivir.”
Kaul said Michigan Medicine has been participating in the Gilead clinical trials for remdesivir but wanted to get more of the drug for patients who might benefit from it but don't meet the strict criteria for participation in the trial, such as having tested positive for COVID in the previous four days.
As the principal investigator for Michigan Medicine's trial, Kaul is getting calls from Michigan families of COVID patients who want to get a loved one access to the drug, he said.
He would like to be able to direct them to whatever hospital or health system has it available, but he had not heard of any Michigan medical centers that had received the medicine through the government allocation process as of Saturday.
He said he was "flabbergasted" by that, considering how hard hit Metro Detroit has been and the number of hospitalized patients that could potentially benefit from the treatment.
"That may change. I think the federal government has recognized they did not do this properly. I suspect they are kind of embarrassed by it," Kaul said.
"We are all hopeful they will do it in a more logical way where the maximum number of people who need it can benefit."