WASHINGTON — In North Carolina last week, President Trump told voters at a campaign rally not to fear Covid-19 because they’d soon have access to a coronavirus “cure.” The experimental treatment, he told supporters the next day in Iowa, made him feel “like Superman.” In Florida, he told seniors they’d soon have access, for free, to the antibody therapy he’d received during his own bout with the virus two weeks before.
It’s a significant shift. Trump campaigned for months on the dubious pledge that a vaccine would be available “before a very special date,” an open nod to Election Day. But as it’s become clear drug companies won’t help Trump deliver on a key campaign promise by Nov. 3, he’s largely dropped the aggressive vaccine rhetoric. Instead, he’s begun to campaign on equally lofty boasts of a Covid-19 cure-all — even though the treatments remain unproven and unavailable to the general public.
“We have to get ‘em approved, and I want to get ‘em to the hospitals where people are feeling badly,” Trump said in a recent video. “That’s much more important to me than the vaccine.”
Trump’s pivot to touting therapeutics underscores his desperation to claim that his government is making significant progress in combating the pandemic. And it is an attempt, too, to turn his own Covid-19 diagnosis from a weakness into a strength, bolstering the dangerous arguments that Americans shouldn’t fear the virus or let it “dominate” their lives.
“Clearly, there’s been a shift in what the President talks about,” said Walid Gellad, a physician and health policy professor at the University of Pittsburgh. “That may just be a factor of the personal experience, although clearly it’s also related to the reality of the vaccine. I don’t know which of those it is.”
Trump’s latest comments have stoked additional fear among public health experts and scientists that Americans will take the president’s advice and largely ignore the pandemic unfolding around them. Even as Trump campaigns regularly in front of thousands of mostly unmasked supporters, case rates are spiking across the country. Over 700 Americans still die of Covid-19 each day.
Even amid the spikes, Trump has argued that Americans should return to business as usual, given the existence of the experimental therapies.
Public health experts are still urging people to continue to follow social distancing guidelines and to wear masks in public. With the weather growing colder, Americans spending more time indoors, and the holiday travel season approaching, experts including Tony Fauci, the government’s leading infectious disease researcher, warn that failure to adhere to basic public health guidelines could have deadly consequences. …
Trump has fixated particular on a treatment he’s referred to as “Regeneron” — in fact, an as-yet-unnamed cocktail of antibodies being developed by Regeneron, a New York drug manufacturer. Trump’s effusiveness even led the Lincoln Project, a coalition of Republicans opposed to his re-election bid, to publish a fake commercial mocking Trump for hawking an unproven cure.
“You’ve got to open up your businesses, open up your schools,” Trump said at a campaign rally in North Carolina on Thursday. “We have incredible therapeutics, we have incredible drugs, we have, in my opinion, a cure. Because I took something, Regeneron, it was highly sophisticated stuff. The antibodies, and Eli Lilly makes an incredible drug.”
It’s unclear whether Americans are taking his words to heart. Trump’s message, however, is clearly out of step with reality, given skyrocketing case rates and a corresponding increase in Covid-19 hospitalizations.
“I have not seen any polling on whether this latest fusillade of claims regarding that great drug ‘Regeneron’ has convinced anyone that there are cures out there, period, let alone readily available ones for the population,” said Peter Bach, a doctor and health policy researcher at Memorial Sloan-Kettering Cancer Center in New York. “I can’t remember how many times the boy had to cry wolf before he was ignored, but I am sure the president has exceeded that number by now, probably by severalfold.”
Trump’s tone regarding new Covid-19 therapies has exceeded even his prior effusiveness regarding vaccines: Since his release, Trump has attempted to convince Americans they’ll soon have access to the same level of treatment he received at Walter Reed.
“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,” Trump said in a video posted to Twitter on Oct. 7, in which he said contracting coronavirus may have been a blessing from God. “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 ‘em, and you’re going to get ‘em free.”
The promises ignore key context: The president is among a small handful of people around the world who’ve received access to the Regeneron antibody therapy outside the setting of a clinical trial. The Food and Drug Administration has not yet issued an emergency use authorization for either therapy — in fact, one trial testing Eli Lilly’s antibody treatment for hospitalized patients was recently paused following a potential safety concern.
As with other once-touted Covid-19 treatments, however, Gellad said the president’s enthusiasm could do more harm than good, especially when it comes to the public’s perception of the FDA. Trump has already telegraphed that his administration will soon issue emergency authorizations for both the Regeneron and Eli Lilly antibody therapies. If the FDA does so, it might appear that Trump’s rhetoric influenced the decision — even if the agency’s scientists didn’t factor in the president’s eagerness. The scenario has already played out twice in 2020, Gellad said: First over the malaria drug hydroxychloroquine and again over the use of blood plasma from recovered Covid-19 patients.
“The perception, and the reality, is that there’s a lot of political interference, whether it’s addressing hydroxychloroquine, plasma, antibodies, or vaccines,” Gellad said. “In reality, all of these drugs might fit the criteria for what FDA would have done probably anyway.”
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Production capacity, price, and plausibility of large scale distribution within a limited time throughout the 50 states and territories – this is never discussed; even if Regeneron’s REGN-COV2 treatment/therapy/serotherapy is proven(at some point, not right now) to be 99% effective.
Regeneron lacks the large scale production capacity needed to supply hundreds of millions of doses, according to their own estimate they could produce around 2 million doses within 5 months using only their production facilities within the US. This is not enough for wide scale vaccination within their NYC metropolitan area, let alone for 50 states.
It would have to be license produced by other facilities and Regeneron would have to agree to that through the FDA(if chosen as such). Otherwise a small scale short term pseudo-vaccination campaign would be pointless within the known global pandemic population size of COVID-19. The effects of the Regeneron treatment could possibly last up to a year(and that is being optimistic for longevity), and only a large scale billion dose production and immunization campaign could be effective within North America(everyone who lives and enters the countries within the continent).
This of course is relevant for all COVID vaccines.
While thousands die in America every week, Trump ignored Covid treatments, until he got a wake-up call. But like a child wanting something NOW, he again disregards the always intricate time-consuming process required to deliver something that is good and safe. He is trying to fool Americans, as the price-tag on the “miracle” drugs this hyper-priviliged man got makes it un-available to all regular Americans. His incoherent ramblings are far below presidential, and underscore that he is becoming more and more unfit for the job.
I do not believe this is a fair criticism. The CDC has been involved in a number of theraputic trials, the FDA has been accommodative, and project warp speed has provided funding for promising therapies. Remdesivir was studied, approved, and mass produced in rather short order. The administration has, in fact, gotten criticism for being too aggressive in approving therapies before their effectiveness is proven, including EUAs for both Hydroxychloroquine (later found to be ineffective, despite early promising results) and Convalescent Plasma (which we still don’t have gold standard evidence on).
I am quite excited about antibodies, but unlike the repurposed drugs, they have an unknown safety profile, so research is necessarily going to be slow to meet ethics rules (you can’t skip any preclinical steps and animal testing, you can’t enroll phase 2 until phase 1 reads out safety, etc.). Regeneron had, in fact, read out its preliminary phase 2 ambulatory patient results a few days before the president was treated with the antibodies and both Regeneron and Eli Lilly are months into phase 3 trials for using their antibodies for prevention. I am not sure what more the federal government could have safely and ethically done to speed things faster, and, in fact, the US has been involved in pretty much every successful drug for COVID other than Dexamethasone (which the FDA appears to still not have authorized, but doctors are likely using it off label, so the lack of EUA is limited).
Charlie, I do not disagree with facts, but the facts are also in Trumps promo of Regeneron’s treatment that is and will not be available to ALL Americans (price, production). And his increasing incoherent rambles are also a clear fact. This man is a very un-fit US president.