When it rains good pandemic news, it pours. On a Monday that brought unexpectedly positive vaccine news from Pfizer Inc. and BioNTech SE, the Food and Drug Administration also granted emergency use authorization to an Eli Lilly & Co. drug to treatment for individuals newly infected with the coronavirus. It's the first to be approved of a promising group of therapies called monoclonal antibodies that mimic the body’s response to infection, and could be a powerful weapon in the pandemic fight.
Some questions remain about Lilly's treatment, called bamlanivimab, which was found to reduce the viral load in patients and may help keep people out of the hospital. It was authorized for treatment at a dose that didn't produce a statistically significant effect in published data, and there's some concern that resistant mutant strains might develop. But with the drug now authorized, the crucial question is who will get access to a highly limited supply.
The government has purchased 300,000 doses, and manufacturing will ramp up; meanwhile, an authorization may come soon for a competing treatment from Regeneron Pharmaceuticals Inc., which would give doctors more options. But with new daily cases exceeding 100,000 in the US, these treatments will have to be rationed for some time to come. The Trump administration plans to leave distribution up to states, prioritizing them based on case rate but offering little additional public guidance. The whole pandemic has demonstrated the failures of a disjointed 50-state strategy. Without more federal help, it’s hard to envision a fair or efficient rollout.
The government used a similar strategy with Gilead Sciences Inc,'s drug remdesivir, used in hospitalized patients. It wasn't a resounding success, with early complaints emerging about limited supply and lack of transparency. Distribution of Lilly's medicine will be even more complicated.
Bamlanivimab appears to work best when given early in the course of the disease, which requires quick testing turnaround. The treatment doesn't seem to help hospitalized patients and may even harm them. On top of that, it needs to be delivered using specialized infusion equipment that's likely not available at your local pharmacy.
It's also not clear who gets the greatest benefit from the treatment with limited available data. There's some evidence suggesting people with risk factors for severe disease need the drug the most, and the authorization highlights those patients. The FDA's definition of high risk is very broad, though, encompassing everyone with a confirmed infection over the age of 65, people with a body mass index equal to or over 35, and various others who have conditions that make Covid-19 especially dangerous. It's an enormous group, far larger than the hospitalized population eligible for remdesivir. Doctors face difficult clinical judgments with little help, and states will have far too many eligible patients.
Future trials may help narrow the drug's use, and distribution questions will be less of a concern as supply builds. Until then, fairness needs to be the guiding principle. It's entirely too easy to imagine inequality and varying approaches in the absence of detailed guidance. The pandemic has been disproportionately hard on communities of color, who are consistently treated unequally by the American health-care system. Without specific preparation and intervention to identify and treat eligible patients in these communities, inequality is likely to extend to antibodies. Rural populations face the dual risk of limited access to both testing and sites that will administer these treatments.
Much of the supply will go to hard-hit states with limited testing capacity. Early identification is crucial to the proper use of this medicine. People who find out about potential exposure early or can pay for access to accelerated testing may have an advantage. Without strict guardrails and a proactive approach, people who happen to know about the treatment or are well-connected may push for access, while those unaware are left behind. President Donald Trump's VIP use of Regeneron's antibody and his adviser Chris Christie's access to Lilly's long before they were available to the public doesn't set the best of examples.
States will do their best to find a way to distribute doses fairly. But they're being saddled with a logistical and ethical dilemma with limited support. With case counts rising every day, the government needs to offer a real plan.
Bloomberg
