Massachusetts government and hospital officials are taking matters into their own hands and working out a plan to share donations of the coronavirus treatment remdesivir, after questions were raised about the federal government’s puzzling distribution process for the drug.
Remdesivir, an experimental drug manufactured by Gilead Sciences, received an emergency use authorization from the Food and Drug Administration on May 1, after the antiviral treatment showed promise in a government-run trial for treating COVID-19. The National Institute of Allergy and Infectious Diseases said preliminary data showed patients who received remdesivir recovered 31 percent faster than those who received a placebo.
The federal government began distributing thousands of doses of remdesivir, donated by Gilead, to hospitals across the country for use with patients suffering from the virus. The distribution is being handled by AmerisourceBergen, a private firm.
But as hospitals learned this week who would be getting supplies of the drug, nobody seemed to understand the rationale behind the decisions.
In Massachusetts, four hospitals were told they would receive the drug, according to the Department of Public Health. Massachusetts General Hospital learned it would get 1,000 doses — enough remdesivir for about 170 patients on what is usually a five-day course, MGH officials said. The hospital had 344 patients admitted with confirmed or suspected cases of COVID-19 as of Wednesday, the highest number in the state, according to DPH data.
But several other major Boston hospitals with large numbers of coronavirus patients were denied federal allocations of the drug, including Boston Medical Center, Beth Israel Deaconess Medical Center, and Brigham and Women’s Hospital.
Meanwhile, as first reported by Stat, two hospitals that were granted allocations have much smaller numbers of confirmed or suspected coronavirus patients, according to state data: MelroseWakefield Hospital in Melrose, which had 51 such patients as of Wednesday, and North Shore Medical Center in Salem, which had 97. The latter said it was receiving 1,200 vials of remdesivir, or enough to treat 150-200 patients.
Southcoast Health System, which operates several hospitals in Southeastern Massachusetts and Rhode Island, said it had also received a supply of remdesivir this week.
According to representatives for MGH and North Shore Medical Center, there was no formal request process. Hospitals were directed to call AmerisourceBergen to determine if they were selected, said an MGH spokesperson. “We are not clear why we were chosen for an allocation,” a North Shore Medical Center spokesperson said.
On Wednesday, Dr. Benjamin Linas, an infectious disease specialist at Boston Medical Center, took his frustration over the distribution process to Twitter: “The injustice is staggering,” he tweeted. “We have the second highest absolute case count” in Boston. “Today, the family of a dying patient asked me why we do not have [remdesivir]. What am I supposed to say?”
With multiple coronavirus treatments in varying stages of testing, remdesivir has attracted major interest from a public and health care industry yearning for tools in the fight against the pandemic.
The Infectious Diseases Society of America sent a letter to Vice President Mike Pence on Wednesday calling for a fairer distribution of the drug across the country: “The plan for distributing remdesivir should be transparent and should be based on state and regional COVID-19 case data and hospitalization rates,” stated the letter. “Supplies of remdesivir should be distributed on a regional basis with equitable distribution within the region to states and within states to hospitals.”
When MGH officials learned this week that other large medical centers were not receiving remdesivir, they quickly decided to reach out to the state Department of Public Health to share their supply with others.
“It became very clear that we had this commodity that the entire city and state needed, and we were not comfortable having it ourselves,” said Dr. Rochelle Walensky, chief of infectious diseases at MGH. “There are other communities that are really being hard hit by this, and we just didn’t feel right having our community have it and others not.”
A DPH spokesperson confirmed that at MGH’s request, “the distribution of remdesivir was discussed at the governor’s COVID-19 medical advisory board. The Massachusetts Department of Public Health was asked to work with the four hospitals that received a distribution to develop a statewide allocation strategy.”
Representatives of North Shore Medical Center, MelroseWakefield Hospital, and Southcoast Health said they will collaborate with the state on redistribution.
"I will now be serving on the Massachusetts committee for remdesivir allocation to help ensure regional representation, as well as equity and efficiency across the Commonwealth,” said Dr. Dani Hackner, chief clinical officer at Southcoast Health.
The Globe’s attempts to reach government agencies and other organizations involved in the drug’s production and distribution produced no clear answers regarding why these four Massachusetts medical providers were chosen, while other hard-hit hospitals across the state were not.
AmerisourceBergen said it “is working closely with Gilead and the US government to distribute remdesivir to hospitals across the nation, regardless of whether they are AmerisourceBergen customers. Decisions on which hospitals and the quantity of the product they will receive are being made by the government.”
Gilead said that it did not decide which hospitals are receiving its drug and that the Federal Emergency Management Agency and Department of Health and Human Services were coordinating the donation “to hospitals in regions most heavily impacted by COVID-19,” according to a Gilead spokesman.
FEMA and the Department of Health and Human Services did not provide answers to Globe questions regarding how distribution decisions were made.
Dr. Paul Biddinger, chief of emergency preparedness at MGH, noted that even as the state plans to move forward with a revised distribution system, the hospital wants to make sure they will not violate any federal rules. “We are trying to actually confirm with the federal government that we’re allowed to do this,” he said.
Other hospitals in the region were hopeful a quick solution would be reached.
“We want to make sure that treatments are used in the most equitable and beneficial way possible,” said Dr. Helen Boucher, chief of geographic medicine and infectious diseases at Tufts Medical Center, which did not receive an allocation of remdesivir.
“We just don’t know how the process worked,” said David Twitchell, vice president and chief pharmacy officer at Boston Medical Center, which will be joining a remdesivir clinical trial next week. The hospital had 237 confirmed or suspected coronavirus patients as of Wednesday, tied for second most in the state. “We’re very thankful that the state has stepped in,” Twitchell said.
As Gilead works to ramp up production of the drug, MGH officials noted that the doses distributed as part of the federal process are nowhere near enough to treat everyone in the state. “With the people in our hospital today we could probably use it up,” said Walensky.
With such urgent need, collaboration is all the more important, MGH officials said.
“There are things that are bigger than any one hospital or system,” Biddinger said, “and this is how we are collectively doing our best to respond.”