Trump Overstates Status of COVID-19 Antibody Drugs
By Jessica McDonald
Posted on October 8, 2020
Calling investigational COVID-19 antibody drugs “cures” in a video posted to Twitter, President Donald Trump incorrectly said the therapies had been authorized and that “hundreds of thousands of doses” were nearly ready.
He also suggested he had personally benefited from an antibody cocktail made by the biotech company Regeneron. It was one of several drugs the president received since he tested positive for the coronavirus.
The drugs in question are monoclonal antibodies, which are synthetic proteins optimized to recognize the coronavirus, or SARS-CoV-2, and in theory should help clear the virus from the body. While many experts view them as promising — and some early data support that enthusiasm — the products are still in clinical trials and have not been proven to be effective for COVID-19 patients, much less cure the disease.
In the first video, which was posted to Twitter on Oct. 7, Trump praised the effects of the Regeneron antibody cocktail he received prior to being admitted on Oct. 2 to Walter Reed National Military Medical Center for a three-day stay.
“I went in and I wasn’t feeling so hot, and within a very short period of time, they gave me Regeneron,” Trump said, incorrectly referring to the cocktail by the company’s name and contradicting his physician on being given the drug at the White House. “It’s called Regeneron, and other things too. But I think this was the key, but they gave me Regeneron, and it was like, unbelievable. I felt good immediately. I felt as good three days ago as I do now.”
The president proceeded to note that another company is also behind a similar drug, and confusingly said both that the drugs had been authorized and that he was trying to help in that process.
Trump, Oct. 7: We have Regeneron. We have a very similar drug from Eli Lilly and they’re coming out and we’re trying to get them on an emergency basis. We’ve authorized it. I’ve authorized it. And if you’re in the hospital and you’re feeling really bad, I think we’re going to work it so that you get them and you’re going to get them free, and especially if you’re a senior, we’re going to get you in there quick. We have hundreds of thousands of doses that are just about ready.
I have emergency use authorization, all set, and we got to get it signed now, and you’re going to get better. You’re going to get better, really fast. This is things that nobody even thought of a few months ago. … I view these, I know they call them therapeutic, but to me it wasn’t therapeutic, it just made me better. OK, I call that a cure. So I want to get these things done. So we have to get them done. We have to get them approved, and I want to get them to the hospitals where people are feeling badly.
In fact, as of Oct. 8, no monoclonal antibody for COVID-19 has received emergency use authorization from the Food and Drug Administration, although two companies have submitted those applications.
Regeneron announced its submission for REGN-COV2, its dual antibody cocktail, hours after Trump’s video landed on Twitter on Oct. 7. Eli Lilly announced a submission for its single-antibody drug earlier the same day; the company and said it expected to apply for an EUA for its combination antibody in November, “pending clinical trial enrollment, once additional safety data accumulate and sufficient supply is manufactured.”
The president should have no involvement in whether the FDA issues an EUA, as that decision is supposed to be up to career scientists at the agency.
Trump later emphasized his own experience once again, calling the antibody cocktail “a cure” and saying that his contracting of the coronavirus was “a blessing from God.”
“Some people don’t know how to define therapeutic. I view it different, it’s a cure,” he said. “For me, I walked in, I didn’t feel good. A short 24 hours later, I was feeling great, I wanted to get out of the hospital and that’s what I want for everybody. I want everybody to be given the same treatment as your president because I feel great.”
“I think this was a blessing from God that I caught it,” he added. “This was a blessing in disguise. I caught it. I heard about this drug. I said, ‘Let me take it.’ It was my suggestion. I said, ‘Let me take it,’ and it was incredible the way it worked. Incredible. I think if I didn’t catch it, we’d be looking at that like a number of other drugs, but it really did a fantastic job.”
Trump acknowledged his unique position as president to receive investigational drugs that are unavailable to nearly all other Americans. According to STAT News, at the time Trump received his dose of the Regeneron cocktail, fewer than 10 patients had been provided the cocktail outside of its trials.
Trump also gave a misleading impression of how available the antibody cocktails would be, should they receive FDA authorization. Along with his figure of “hundreds of thousands of doses that are just about ready,” Trump said near the end of the video that “the drug companies have just made a lot of it.”
And in a follow-up video posted to the president’s Twitter account on Oct. 8, but filmed the day before, Trump addressed America’s seniors, repeating his claims that the antibodies are “a cure” and saying the drugs were going to be available “immediately.”
The companies have not provided such optimistic figures. Regeneron said on Oct. 7 that at the moment, it has enough doses to treat “approximately 50,000 patients” and expects to have enough for 250,000 more “within the next few months.” Eli Lily estimates that for its single antibody, it will have 100,000 doses in October, with up to 1 million doses by the end of the year.
That would suggest that at most, only about 150,000 doses of these drugs would be immediately available with the potentially forthcoming EUAs.
In both videos, Trump also promised the monoclonal antibodies would be free to the public, saying in the second, “We’re going to take care of our seniors all free.” There are plans in place for some of the initial doses to be free, it’s unclear how long that will last.
The U.S. government signed a deal with Regeneron in July to produce a fixed number of lots of its cocktail at government expense, which would be provided to Americans at no cost. The exact number of doses those lots will yield depends on the dosage that the trials determine is safe and effective, but could range from between 70,000 to 300,000 treatment doses. After that, there is no guarantee the drugs would be free and patients at all times could be charged for being administered the therapy.
“Antibody drugs will be critical bridge to Covid vaccine, but supply is very limited,” Dr. Scott Gottlieb, a former FDA chief under Trump, said in an Oct. 7 tweet. “We needed to pay companies to convert existing manufacturing and stop production of some drugs to free space for these – and didn’t. It’s not too late.”
In another tweet, Gottlieb demonstrated how limited even 300,000 doses might be, calculating that it would be enough to treat all Americans over the age of 65 who are infected with the virus for only a bit more than a month. “About 15% of Covid cases diagnosed each day are over 65. Based on that age criteria alone, >7,500 patients per day could be indicated for this drug, 225K per month,” he said. “We need more supply, which may not be possible now for 2020, but could be available in 2021 if we take right steps.”
As for whether Trump benefited from Regeneron’s cocktail, that’s impossible to know. Only through clinical trials is it possible to know if the drugs are safe and effective, and even then, it’s uncertain how much any particular therapy will help an individual.
As Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said in an Oct. 8 interview on MSNBC, it’s not even clear that Trump has fully beaten the coronavirus yet.
“One of the issues that we all have to be aware — and his physicians are aware of this — that the history of COVID-19 is that you could look and feel like you’re doing reasonably well, and after a couple of days you could have a downturn, namely have a reversal,” he said. “That’s possible. The chances of that happening, I don’t know. As good as he looks, I don’t think that’s going to happen, but I don’t know. But you have to be heads up that it might happen.”
Fauci also cautioned against coming to premature conclusions about the effectiveness of the antibodies, although he said he thought it was likely that they did help the president.
“The preliminary data from those antibodies are favorable. I think it’s a reasonably good chance that the antibody that he received, the Regeneron antibody, made a significant difference in a positive way in his course,” he said. “But when you have only one, we refer to it in medicine as N equals 1, when you have only one, you can’t make the determination that that’s a cure. You have to do a clinical trial involving a large number of individuals compared either to a placebo or another intervention.”
Other physicians are not so sure the antibody cocktail is responsible for his condition — at least not at the speed that he claims — and point out that Trump was also given other drugs, namely the antiviral remdesivir and the steroid dexamethasone.
Dr. Peter Chin-Hong, an infectious disease specialist at the University of California, San Francisco, told the New York Times that there was no chance the cocktail “cured” Trump in 24 hours, and suspected the president might be feeling so good because of the dexamethasone.
Of course, Trump also might not have needed any of the medications, as most COVID-19 patients recover without them.
The existing data on the various monoclonal antibodies is generally positive, but are hardly conclusive at this point — and do not point to a “cure” for all patients.
Regeneron announced preliminary results from its first 275 patients in a Sept. 29 press release, saying that its dual antibody “reduced viral load and the time to alleviate symptoms in non-hospitalized patients.”
Notably, the company said it saw differences in the impact of the cocktail in patients who were given the cocktail early versus late in their disease courses. Those who had already developed antibodies on their own saw less of an improvement compared to controls, suggesting that for the drug to be most effective, it would have to be delivered shortly after a rapid diagnosis.
Eli Lilly also released interim results on Oct. 7 for its two-antibody cocktail, finding the combo reduced the viral load as early as three days after treatment in COVID-19 outpatients. The drug also reduced symptoms and hospitalizations and ER visits, with 0.9% of treated patients entering a hospital compared with 5.8% of those getting the placebo. The latter result, however, barely reached statistical significance, given the small size of the study.
But the antibody cocktail isn’t the drug Eli Lilly is moving forward with first. The one the company submitted for its EUA, which targets higher-risk patients with mild-to-moderate COVID-19, is for just one of the two antibodies.
The data on the single antibody treatment is slightly less impressive, with only the highest dose of the antibody showing a decrease in the viral load after 11 days in a phase 2 trial. Across the three doses tested, there was a drop in the rate of hospitalization or ER visits compared with controls — 1.7% versus 6% — which was based on just 14 such events.
The results for both companies reflect the outcomes of only several hundred patients and have not been published in peer-reviewed journals.
Many experts, such as Fauci, are optimistic. But it’s premature to claim that the COVID-19 monoclonal antibodies are safe and effective before the trial results are in, as Trump did in his second video, when he called the therapy “totally safe” but “powerful against this disease,” or to brand them cures.
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