Trump also claimed in the videos he had granted the drugs an emergency use authorization (EUA), a designation that would make the medicines more broadly available. But the companies said they have submitted the requests to the Food and Drug Administration — a process that the agency has repeatedly tried to assure the public is based on science and free of political interference.
“We’re going to make them available immediately, we have an emergency use authorization that I want to get signed immediately,” Trump said in the video posted Thursday afternoon.
Experts said that by inserting himself and his own recovery story into an area of ongoing medical research, Trump risks disappointing and confusing the American public with a hopeful anecdote that may not reflect how the drug works for others or how broadly it will become available when it is approved, which he also promised would be free.
“The fundamental problem with monoclonal antibodies is there’s not enough worldwide capacity to produce enough of them to have a real impact on the disease,” said Ezekiel Emanuel, a health policy expert who is advising the campaign of Joe Biden. “Yes, they might be great, but for a small number of patients.”
The president also said in the video that people in hospitals should receive the drugs, but the data so far supports using them in people with mild or moderate illness who are recently diagnosed. Early data from ongoing studies have shown evidence the drugs reduce symptoms over days, knock back the virus by reducing levels in the body and may cut down the need for further medical visits. That data is considered very promising, but not definite evidence of a cure.
Trump’s endorsement of monoclonal antibodies comes as the authorization of a coronavirus vaccine before Election Day appears increasingly unlikely. Such an okay had loomed as a potential “October surprise” that some believed could alter the course of the election with the prospect of a quick return to normalcy. An influential medical journal argued in an editorial Wednesday that the Trump administration’s handling of the pandemic took “a crisis and turned it into a tragedy,” so the antibody drugs could offer a rare victory.
Trump said in one video that the therapies were “more important” than the vaccine, the same day that both companies disclosed that they had filed with regulators for emergency authorization to use the drugs in some patients. On Fox Business on Thursday morning, he called the Regeneron drug “a gift from heaven.”
Both the Regeneron and Eli Lilly drugs are being tested in clinical trials, and no one knows if the former helped Trump recover, whether it did so in addition to all the other treatments he received or whether he would have recovered on his own as part of the natural course of the disease.
Several experts said that Trump touting a drug as a cure will make it even harder to persuade patients to participate in ongoing clinical trials where they will have a chance of receiving a placebo. Those trials will be essential to figure out how well the drugs really work and which patients benefit most from the drug, since there are not enough doses for broad distribution.
“The problem is the president is a single-man wrecking ball,” said Nahid Bhadelia, an infectious-diseases physician at the Boston University School of Medicine. “He’s destroying the mechanisms by which we figure out the efficacy of drugs, touting one thing and then another.”
“Once they issue the [authorization], it will kill the trials, and as a society we will have less information moving forward as far as who does it work in, and who to prioritize,” said David Boulware, an infectious-diseases physician at the University of Minnesota Medical School. “There’s going to be a limited supply.”
As Trump did with the anti-malaria drug hydroxychloroquine and convalescent plasma transfusions, experts said he is overstating the evidence and politicizing medicine — in this case boasting that the drugs are a panacea, despite the fact that the evidence so far is suggestive that they are helpful in reducing symptoms over several days, not in 24 hours, reducing the levels of virus in people’s bodies and decreasing the need for follow-up medical visits.
“The problem is every therapy for coronavirus has become politicized — every single therapy, and that’s the last thing you want in a pandemic, so this is just next in line,” said Walid Gellad, director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh.
In an interview earlier this week before Trump’s video was posted, Leonard Schleifer, chief executive of Regeneron Pharmaceuticals, said that his company wanted regulators to decide when their drug merits an authorization for emergency use based on the data.
“We are very afraid that this will become a political football, where … if we get an [authorization], people will say we didn’t deserve it and only got it because of political reasons,” Schleifer said. “Or if we don’t get an [authorization], people will say we did deserve it and didn’t get it for political reasons. We don’t want this to be a political decision.”