President Trump asserted the medication had cured him of COVID-19. Rudy Giuliani and former New Jersey governor Chris Christie raved about receiving it during their bouts of coronavirus.
Yet only a fraction of the available doses of monoclonal antibodies have made it into the arms of less-famous patients, despite preliminary data suggesting the experimental drug might keep people out of the hospital.
Nationwide, patients have received 20 percent of the 378,000 doses that the federal government has distributed to states.
In Massachusetts, health officials said they have sent 5,650 doses to 14 hospitals — and as of Thursday, nine had reported treating a mere 133 patients.
Advertisement
The state is requiring hospitals to ensure that poor and vulnerable communities have access to the medications, not just the Giulianis of the world. But getting the drug out of the refrigerator and into patients’ arms has proven to be challenging, especially as hospitals cope with a surge in COVID-19 patients and the need to vaccinate its workers. Monoclonal antibodies are given intravenously to select outpatients, who are eligible only for 10 days after symptoms start. And the data have not established that these medications are effective.
“It is an enormous task to deliver this particular drug,” said Dr. Doug Salvador, senior vice president and chief quality officer for Springfield-based Baystate Health. “That’s harder to do when we don’t know if it works.”
Baystate ultimately decided to offer the medication. But even with more than 2,000 doses on hand and space to treat a dozen patients a day, the hospital doesn’t have enough staff available to administer the medication. So far it has treated only 23 patients and has had to turn some away, choosing recipients by lottery.
Because they’re administered intravenously, but only to those who don’t need hospitalization, providers have to find a place to keep these highly infectious patients separate from others and designate nurses to treat and monitor them. They also must find and screen prospective patients quickly. The drug is most effective within 72 hours of symptom onset and must be administered within 10 days, and only to those with mild to moderate symptoms.
Advertisement
If found eligible, patients have to travel to an infusion center and spend an hour receiving the medication and another hour watching for rare allergic reactions.
And the benefits remain uncertain, although the risks are considered low. The studies so far are small and preliminary, showing that high-risk patients who received one formulation of the medication were less likely to be hospitalized.
Faced with all this trouble and ambiguity, some patients — and several major hospitals in Massachusetts — have decided to take a pass. Those that participate are taking it slow.
Boston Medical Center, for example, has administered only about 10 of its 114 doses.
“We intentionally started very slow. We wanted to work out any kinks,” said Dr. Tamar Barlam, chief of infectious diseases. The hospital has been treating about two patients a day and plans to expand to four a day and also offer the treatment at community health centers and nursing homes.
But patients who are mildly ill often consider a trip to the hospital for an unproven medication to be hardly worth the trouble — and half those that Boston Medical Center found eligible have declined.
Advertisement
In contrast to the cautious approach in Massachusetts, the Rhode Island Department of Health has aggressively promoted monoclonal antibodies, touting them at press conferences and making them available in infusion centers, hospitals, and nursing homes. Dr. James V. McDonald, a health department medical director, said that more than 500 Rhode Islanders have received the treatment — almost four times the number in Massachusetts.
“We’re very confident that we’re keeping people out of the hospital,” he said.
Monoclonal antibodies are lab-made copies of the natural proteins that people produce to fight off infections. “It’s like an instant immune system,” McDonald said. “It stops the virus from replicating and entering the cells.”
Monoclonal antibodies have been shown to be effective in treating other viruses as well as cancer. But the versions tailored to fight coronavirus remain experimental.
In November, the US Food and Drug Administration concluded the possible benefits justify “emergency use authorizations’' for two versions of COVID-19 monoclonal antibodies, one made by Eli Lilly and Co. and a two-drug combination made by Regeneron.
But the drugs have not made it through the full approval process, and national organizations have declined to recommend them, saying the data so far are too weak.
Still, expecting the demand for these drugs to be greater than the supply, the Massachusetts Department of Public Health convened a working group to consider how best to distribute them. A top concern was that well-connected people would get first dibs on a limited supply.
Advertisement
“We were committed to doing this in the most medically optimal way and the most equitable way,” said Dr. Helen W. Boucher, chief of infectious diseases at Tufts Medical Center and a member of the working group.
The group decided that people who are 65 and older and severely obese people should get priority. Next in line are those age 55 or older who have health conditions that put them at high risk, such as diabetes, kidney disease, or heart disease.
If hospitals have more eligible patients than available doses, they will choose recipients by lottery. But 20 percent of the available slots must be reserved for people who live in zip codes with high poverty levels and poor health outcomes or who live in the state’s coronavirus hot spots.
Hospitals with the desire and wherewithal to offer monoclonal antibodies requested doses from the state, which obtained them from the federal government. Fourteen hospitals, including three long-term-care hospitals, stepped up. Notably missing from the list are the Beth Israel Lahey Health system and UMass Memorial Health Care.
“To date, we haven’t felt the data is compelling us to try to start to offer it, nor has there been a demand from our clinicians,” said Dr. Eric Dickson, the UMass hospital system’s CEO. That could change quickly if new data come in, he noted. Meanwhile, he said, the hospital is considering setting up an antibody infusion center at its COVID-19 field hospital if there is an outbreak among homeless people.
Advertisement
Mass General Brigham, the state’s largest health system, has decided to offer the medication and received 721 doses. But it took some discussion about whether the evidence of effectiveness justified the effort required, said Dr. Emily B. Rubin, who is leading the program at the hospital group .
“On balance people felt that it was reasonable to start doing this,” she said. “It is entirely possible and maybe likely these [medications] will show a significant benefit when all the information is in.”
Tufts Medical Center reached a similar conclusion, despite efficacy data Boucher described as “not overwhelming.” So far the hospital has administered about 25 of its 207 doses, but Boucher expects the pace to pick up — “sadly, because there is a surge.”
When Tufts called Mike Mokler, a 67-year-old South Boston resident, to tell him he had tested positive for COVID-19, he readily agreed to the treatment, even though he understands that it’s experimental. His age, as well as his high blood pressure and diabetes, puts him a high risk of complications from the illness. And his daughter is pregnant.
“I said, ‘yeah, sure,’ ” Mokler said Thursday after getting the infusion. “I don’t want to end up on some machine and not see my grandson be born.”
Felice J. Freyer can be reached at felice.freyer@globe.com. Follow her on Twitter @felicejfreyer.