Some doctors have serious reservations about the Trump administration's Covid-19 antibody treatment rollout.
Doctors from Harvard Medical School shared their concerns in an editorial published Wednesday in the Journal of the American Medical Association, saying they need clearer insight on who such monoclonal antibody treatments are best for, how they'll be distributed and how much they'll cost.
The US Food and Drug Administration gave Eli Lilly's monoclonal antibody treatment emergency use authorization on Monday. On Tuesday, the US Department of Health and Human Services said it would roll out the treatments as early as this week.
"Getting new therapeutics like this to patients has the potential to save thousands of lives and significantly reduce the disease's burden on our health care system," HHS Secretary Alex Azar said at a news conference.
Currently, there are over 80,000 doses available for allocation and distribution, Azar said. Lilly told CNN that at the beginning of the first quarter of 2021 it expects the supply of the antibody therapy will "increase substantially."
The US government has a contract for 300,000 doses of the therapy through December with the option to purchase another 650,000 doses through next June.
For now, with the limited number of doses, states that have a larger share of the country's total number of confirmed Covid-19 patients, as well as those regions with a larger total of confirmed hospitalized patients, will be given priority.
The JAMA editorial, written prior to the distribution announcement about the Lilly treatment, is focused on the Regeneron treatment that hasn't yet received an emergency use authorization yet. Dr. Robert Goldstein, an instructor in medicine at Harvard Medical School and a co-author of the editorial, said he believes Regeneron will be OK'd soon and his concerns extend to both treatments.
While treatments are badly needed, Goldstein said, doctors still don't have a lot of detail.
Some early data from the Eli Lilly trial was published in the New England Journal of Medicine in October, but Goldstein said company press releases are the source for much of what doctors know about Lilly's treatment and the one made by Regeneron, which was used to treat President Trump for Covid-19.
"We don't like to practice medicine by press release," Goldstein told CNN. News releases may reassure investors, he said, but they leave doctors with too many questions.
He said with the details he's heard about the monoclonal antibody rollout feels like "remdesivir all over again."
Remdesivir, an antiviral, received an EUA from the FDA in May.
"With remdesivir, we were given no instruction over who would benefit from the medication, how to best distribute a very limited resource, how to make sure that we were doing the right follow up to see if it was effective," Goldstein said.
The FDA authorized doctors to use Lilly's treatment in adults and children 12 and older who have mild to moderate cases of Covid-19 and in patients with certain underlying health conditions.
"In the end, we have to make a lot of decisions on our own without data and we'll be worried, who best to give this very limited resource to so that we can prevent the most amount of harm?" Goldstein said.
Government official: 'There'll be challenges'
Goldstein said he also thinks the logistics are "going to be a nightmare."
Patients get the treatment through an infusion that takes an hour and needs to be done at a health care facility that has access to emergency treatment in case there are problems. The patient then needs to stay for another hour for observation.
Goldstein is concerned these treatments could strain the health care system and would also likely exclude patients treated by rural and safety net hospital systems that don't have the capacity for large-scale infusion operations.
Federal officials said this week the distribution of these treatments won't be easy.
"We anticipate that initially, there'll be challenges for the health care system in administering IV infusions to infected patients," Dr. Janet Woodcock, the head of therapeutics for Operation Warp Speed, said at a briefing Tuesday. She said the government and Lilly have distributed a playbook to help health care providers think through the challenges, and figure out the best way to set up infusion centers.
"We believe there will be multiple solutions to these challenges depending on the setting and we look forward to working with the healthcare system in rising to this challenge," Woodcock said.
The other concern, Goldstein and editorial co-author Dr. Rochelle Walensky wrote, is cost.
President Trump said in October that these treatments would be free. HHS said Tuesday there would be no charge for the Lilly treatment itself, but there will be a cost for its administration. The Centers for Medicare and Medicaid Services said it would pay that cost for its beneficiaries -- about $300 a treatment.
That payment structure could worsen the inequities in the health care system, Goldstein said.
Billed through outpatient clinics and centers, patients without insurance have had "relatively limited reimbursement" from the government, Goldstein said.
Many clinics and medical centers are not eligible for federal programs that would pick up costs, "leaving the exorbitant outpatient cost burden on the patient," the editorial said.
With nearly 8 million residents losing their employee-sponsored health insurance due to the pandemic,the editorial said, it could worsen "disparities in insurance coverage for Black and Latinx people" and leave the communities with the highest rates of infection "unable to afford the best possible treatment."
Following up after treatment
The editorial's final concern is that there is no obligation for doctors to document how well the therapy works.
"What we saw with remdesivir is that we gave it to a lot of people, but there was no registry gathering information about how the drug worked in these patients and it took us a very long time through the randomized control trial process to find out that remdesivir actually doesn't improve mortality and has very minimal benefit overall," Goldstein said.
"You know, you would think if we're going to do this again with monoclonal antibodies from the get-go, we should be creating a registration so we'd get a national look at all the outcomes of all the people who receive the infusion to prove to ourselves that this is actually effective."
Goldstein said he understands that the country needs to move forward quickly in a public health crisis, especially if treatments can reduce hospitalizations. Covid-19 hospitalizations in the United States reached an all-time high Tuesday.
"But we can do this better," he said. "We know that we can do this better and we should be doing it better."