With hydroxychloroquine a bust and vaccines not coming until after the election, President Donald Trump is touting a new silver bullet against COVID-19: monoclonal antibodies. “They call them therapeutic, but to me it wasn’t therapeutic,” he said in a video he tweeted on Wednesday, five days after receiving the experimental treatment from the biotech company Regeneron. He claimed that he felt better immediately. “I call that a cure,” he said. “It’s a cure,” he said again, defying whoever might have told him to please just say “therapeutic” instead.
Preliminary and still-unpublished data from small studies suggest that monoclonal antibodies, which are lab-grown versions of antibodies the immune system naturally makes to fight pathogens, are indeed promising. Although Trump claims to be on the mend from COVID-19, it’s impossible to conclude from his case alone that the treatment is a “cure,” especially given that he got a “kitchen sink” of treatments. “No one ever got the drugs he got before, in the sequence he got them,” says Myron Cohen, an infectious-disease researcher at the University of North Carolina who is studying monoclonal antibodies in clinical trials against COVID-19.
The president is only one data point. Clinical trials need thousands of data points to determine whether a treatment works, and his endorsement could ironically make it harder to recruit patients for the trials. In hyping a treatment without the data proving that it works and without the groundwork for deploying it “immediately,” as Trump said yesterday he wants to do, he is breezing right past the scientific and logistical challenges still ahead. Trump might have gotten antibodies immediately, but most Americans won’t.
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First, there simply are not yet enough doses in the world. Regeneron currently has enough doses for 50,000 patients. Eli Lilly, which makes a different COVID-19 monoclonal-antibody therapy that is also in clinical trials, says it will have 100,000 doses in October. To put that in context, the United States has 50,000 new cases of COVID-19 every day.
The manufacturing of monoclonal antibodies can’t just scale up on a dime to treat everyone, says Howard Levine, who leads a group of pharmaceutical manufacturing consultants at BioProcess Technology Group. The antibodies are made inside large stainless-steel tanks using genetically engineered ovary cells from hamsters. Like all living things, they can grow only so fast. The tanks are also sophisticated pieces of equipment that can take months to install, Levine says. Regeneron and Eli Lilly have already been increasing manufacturing capacity, and they expect to have 300,000 and 1 million doses, respectively, by the end of the year. The two companies have recently also filed for an emergency use authorization—a looser and faster process than formal approval by the Food and Drug Administration—-which Trump says will come soon.
The monoclonal antibodies will have to be reserved for patients who are at highest risk for eventually developing severe COVID-19. “To be able to treat thousands [of patients] is probably doable,” says Wayne Marasco, who studies monoclonal antibodies at Harvard. “Tens of thousands is pushing it, short-term.” Doctors will have to predict who might benefit the most. People who are older, have underlying conditions, or are already exhibiting serious symptoms such as low oxygen—like the president himself—would be more likely to get monoclonal antibodies.
But doctors will have to make the decision early in the course of illness, before those patients get seriously sick. Monoclonal antibodies are likely to work best when the virus is still trying to gain a foothold in the body. In general, you want to “stop the replication of a microbe—in this case, the virus—at the earliest point in time,” Cohen says. But stopping the virus depends on patients being able to get tested for COVID-19 early, receive their results quickly, and go to a hospital that stocks an experimental treatment before they really even need hospitalization. For now, monoclonal antibodies have to be administered through an IV, so they can’t be offered at pharmacies or at most doctor’s offices.
These hurdles don’t pose a problem for the president, who has the very best medical care the country has to offer. But as my colleague Olga Khazan writes, COVID-19 treatment is markedly less comprehensive and accessible for the average person. Ordinary Americans have repeatedly, in the course of this pandemic, experienced delays in testing. And when the U.S. earlier this year began allocating initially scarce doses of the antiviral drug remdesivir, which Trump has also taken, many hospitals came up empty-handed.
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Trump’s obsession with monoclonal antibodies could also backfire in another way. All the new focus on the treatment might ultimately complicate the studies that will actually prove whether it works. One set of patients in clinical trials always receives a placebo. If patients can be guaranteed to get monoclonal antibodies through compassionate use or emergency use, they might have little incentive to join a trial in which they aren’t guaranteed to receive the real deal. At the same time, the endorsement of a deeply unpopular president who has little credibility on the coronavirus could discourage patients from trying the new treatment. After all, Trump repeatedly hyped hydroxychloroquine as a “game changer” and mused about using bleach and sunlight. The politicization of hydroxychloroquine did, in fact, make it more difficult to recruit patients for trials testing the drug, which ultimately found that it had no benefit in treating COVID-19.
In his remarks about monoclonal antibodies on Wednesday night, Trump couldn’t help taking credit. His disease was a “blessing in disguise” for the whole country to learn about monoclonal antibodies, he said. “I think if I didn’t catch it, we’d be looking at that like a number of other drugs.” And Trump really can take some credit for publicizing monoclonal antibodies. For many months, these therapies have flown under the radar, overshadowed by available off-the-shelf drugs like remdesivir and by the promise of vaccines that might prevent infection altogether. Operation Warp Speed has spent more than 10 times as much money on vaccines as it has on monoclonal antibodies. The treatment could have used a little boost, but instead the president jumped straight to calling it a “cure.”
The early data on this treatment—from the trials, not from Trump as an individual—suggest signs for optimism. “I’m really, really excited and happy about the results that have been presented,” Cohen says of the preliminary data from the Eli Lilly and Regeneron trials. But it’s too early to say that they’ll work for sure, and certainly too early to say that they can end the pandemic. Even if monoclonal antibodies do work, most Americans won’t find them as easy to get as the president did.