A day after the Food and Drug Administration announced tougher measures for a coronavirus vaccine approval, dashing President Trump’s hope of getting a vaccine out before the election, the president put out a video on Twitter suggesting he had changed course: a promise to bring the American people a Covid-19 “cure.”
Following his admission to the hospital Friday, “within a very short period of time, they gave me Regeneron … and it was, like, unbelievable. I felt good immediately,” Trump said in the video. The president then claimed “hundreds of thousands of doses” of the Regeneron drug were nearly ready, and that Americans could “get ’em and you’re going to get ’em free.”
“I call that a cure,” he added, saying it’s a “blessing from God” that he got infected with the virus, which has killed more than 212,000 Americans.
Before we go any further, Regeneron is the name of a pharmaceutical company that manufactures one of the experimental treatments Trump received, not the name of the drug. The drug itself, REN-COV2, is an experimental “monoclonal antibody cocktail.”
In theory, the synthetic antibodies are supposed help patients mount an immune response early in their illness — slowing the virus from progressing into the cells and preventing it from causing serious disease or death.
But the cocktail is still considered experimental because clinical trials are ongoing and it hasn’t been approved for market by the FDA. Trump was only able to access the treatment through the FDA’s “compassionate use” provision, whereby unapproved drugs are administered to seriously ill patients who have no other treatment options on a case-by-case basis. (Whether Trump should have gotten the antibodies this way is a matter of ethical debate.)
All we know about its effectiveness comes from a September 29 Regeneron press release, as Vox’s Umair Irfan reported, about a multi-phase, randomized, double-blind clinical trial involving only 275 people.
While the company did report promising results — the treatment cut the viral load of Covid-19 patients who were not hospitalized, and it reduced the time it took to resolve symptoms — these are very early, unvetted findings. They say nothing of whether the drug cut the risk of death or “cured” people.
“The sample size is pitiful,” said David Nunan, a senior research fellow at the Center for Evidence-Based Medicine at Oxford University, referring to the 106 participants in the trial who reported the main outcome of symptom alleviation in the interim results. “There’s going to be huge uncertainty, and any of the differences we see in [the treatment group compared to the placebo group] are unlikely to be statistically significant — meaning they could just be chance effects.”
Data from the trial hasn’t yet been peer-reviewed. And, again, the trial isn’t even finished.
It’s the same story for another antibody therapy from the drug company Eli Lilly, which Trump also mentioned in the video. No published data. Just a press release.
There’s no way to evaluate the Regeneron treatment until the company publishes its data
Science by press release is not reliable science. Drug companies are notorious for exaggerating and skewing their early findings in public announcements to grab attention and boost investor interest.
“There’s a natural conflict of interest in people putting out the press release,” Nunan said. “Why wouldn’t they release something favorable [about] their treatment?”
Remember in May, when Moderna — the company with a coronavirus vaccine that’s far along in clinical trials — put out a press release about promising phase 1 results. While it first caused the company’s stock valuation to swell, vaccine researchers pointed out in Stat that the information in the press release was way too preliminary and vague to gauge whether the vaccine was actually working.
Similarly, researchers at Oxford University were also criticized for announcing the results of their trials of dexamethasone via press release instead of a peer-reviewed paper or publishing their data. (Dexamethasone is a corticosteroid treatment being used for Covid-19 that Trump has also been given.)
The infectious disease doctors Vox spoke to about Trump’s treatment with the Regeneron cocktail were also leery of how little firm data there is about the drug.
“There’s a reason we’re not giving this to patients [yet],” said intensive care doctor Lakshman Swamy, who works with the Cambridge Health Alliance. “We don’t know enough about it.”
“This is very, very early data,” said Joshua Barocas, an assistant professor of medicine at Boston University and infectious disease physician at Boston Medical Center.
“The monoclonal antibody is just not tested,” Jen Manne-Goehler, an infectious diseases doctor at Brigham and Women’s Hospital, told Vox.
Plus, even if the experimental drug looks promising in early research, Swamy noted, “people said the same thing about hydroxychloroquine,” the malaria drug — also embraced by Trump — now known to be ineffective for Covid-19.
Trump’s single case is not enough to draw conclusions about the drug
As the Times’s Katie Thomas reports, Regeneron is now seeking FDA approval for its monoclonal antibody therapy, raising fears that Trump may pressure the FDA to approve the treatment in time for the election.
What drug regulators are supposed to do in this situation is wait for more carefully reported data on many patients to evaluate the treatment’s efficacy and safety. (The FDA did not respond to the Times’s request for comment.)
“We need people to be enrolled in trials,” Swamy said. “Whenever a high-profile case gets a therapy or doesn’t, the public is swayed based on what happens in that one case.”
The issue is that one case, no matter how high-profile, isn’t reliable evidence of a drug’s effects or safety. What’s more, the Trump case is probably not even representative. He got a higher dose of the antibodies than what’s being tested in the clinical trial. And although Trump pointed to the Regeneron treatment as the reason for his apparent turnaround, we can’t be sure the cocktail made a difference in his case. He’s been on at least two other Covid-19 drugs, according to his doctors: One is the antiviral remdesivir, and the other is dexamethasone.
Nunan called it “massive confounding.” “You’ve got no idea as to which of those interventions if any were having an effect,” he said.
Leana Wen, an emergency physician and public health professor at George Washington University, told NPR the president is likely “the only person in the world to have received this combination of treatments.”
For now, Trump is not out of the Covid-19 “red zone.” Around seven to 10 days after symptom onset, even patients who appear to be stable can take a turn for the worse. (Trump reportedly started to experience symptoms last Thursday.) He may also still experience side effects from his multiple therapies.
If the Regeneron cocktail does make it through clinical trials and gets approved, it won’t quite be free for all Americans, said Craig Garthwaite, a health economics professor at Northwestern University’s Kellogg School of Management.
The government — with taxpayer dollars — already invested $450 million in Regeneron to develop and manufacture an undetermined number of doses (between 70,000 and 1.3 million, depending on the final dosing and how the drug is used). So though the company has said the drug will come free of charge, Garthwaite said, “that’s because we already entered into a supply agreement.”