WASHINGTON _ President Donald Trump is promising emergency approval of a drug produced by Regeneron, which he credits with his own swift recovery from COVID-19, as a way to appeal to senior citizens who are breaking sharply away from his campaign over his response to the pandemic.
The last-ditch effort to shore up a voting demographic that was key to his victory in 2016 has raised new concerns among clinicians and infectious disease experts that the antibody cocktail, which is in early clinical trials, will receive fast-tracked approval well before sufficient data is collected on its safety and effectiveness.
Regeneron submitted its application for an emergency use authorization on Oct. 7, promising up to 50,000 doses upon approval and 300,000 over the coming months after Trump released a video touting the drug as a "cure" for COVID-19.
Early clinical trials of the drug have shown promise, indicating it may reduce the amount of virus in infected individuals. So far 2,500 volunteers have been tested, Alexandra Bowie, a spokeswoman for Regeneron, told McClatchy.
Trump is one of a small number of people who has received the drug outside of that group _ a regimen he believes was "key" to his health improvement, and his ability to get back on the campaign trail, less than two weeks since his diagnosis.
"It is clearly not appropriate for the president or any elected official to weigh in on issues of drug approval," said Dr. Eric Toner, senior scholar at the Johns Hopkins Center for Health Security. "It is a decision that should only be made by dispassionate scientists on the basis of the science. The president's anecdotal experience should have no impact."
Two senior officials involved in the administration's pandemic response told McClatchy that the door is all but closed on the possibility of a vaccine announcement before Nov. 3. The prospect of a vaccine announcement was viewed for months within the Trump campaign as a potential boon before Election Day.
One official said that the White House had accepted new FDA guidelines that would all but guarantee a slower, rigorous vaccine approval process. "Importantly, any new vaccine must meet the FDA's rigorous standards for quality, safety and efficacy, and will be verified in consultation with the independent experts of the vaccine advisory committee," the official said.
Two pharmaceutical companies with vaccines in Phase III clinical trials _ Johnson & Johnson and AstraZeneca _ have reported delays in testing. Executives at two others _ Moderna and Pfizer _ have said they do not anticipate collecting enough data for FDA review until November, at the earliest.
Trump appeared to acknowledge that reality in a video shot from the White House during his recovery last week.
"We're going to have a great vaccine very, very shortly," he said. "I think we should have it before the election, but frankly the politics gets involved, and that's OK. They want to play their games. It's going to be right after the election. But we did it, nobody else."
Instead, Trump said that treatments like Regeneron are "much more important to me than the vaccine."
"We're taking care of our seniors," he said in a second video posted the following day. "You're not vulnerable, but they like to say 'the vulnerable' _ but you're the least vulnerable. But for this one thing, you are vulnerable. So am I. But I want you to get the same care that I got."
Three weeks before the election, Trump is in need of a boost with this critical constituency.
Recent polling shows that Trump is losing support among voters 65 and older at a rapid clip, primarily due to his coronavirus response. His Democratic rival, former Vice President Joe Biden, is beating Trump among seniors by a significant margin of 27 points.
It is a concern that the Trump campaign is taking seriously. Bill Stepien, Trump's campaign manager, told reporters Monday that poll-tested advertisements targeting senior voters will be released this week designed to regain support. "I'm absolutely certain that it will be addressed," Stepien said.
Courtney Parella, deputy national press secretary for the campaign, said Trump was facing the pandemic by "making new treatments available to our nation's most vulnerable."
Trump received an 8-gram dose of Regeneron's antibody cocktail, the highest available, at the outset of his care.
It is unclear whether the Food and Drug Administration will approve the emergency use request.
Angela Rasmussen, a virologist at Columbia University, agreed that it would be inappropriate for the FDA to issue emergency authority to Regeneron for a drug that has undergone so little testing.
And doing so would only grant access to a fraction of the patients who are diagnosed with COVID-19, she added.
"Regeneron only has 50,000 doses of its antibody cocktail available for therapeutic use," Rasmussen said. "There are currently more than 50,000 new cases per day, so the supply of the drug is woefully insufficient to meet the demand. Even if there is a EUA (Emergency Use Authorization) issued, very few people would actually be able to access it, whether it works or not."
Addressing concerns over supply, Bowie said in an email that the company's manufacturing partner, Roche, "is scaling up and expects to begin delivering product in the first quarter of 2021. Once both companies are operating at full manufacturing capacity, we expect to produce at least 2 million treatment doses annually."
"It's important to remember our medicine is one of two monoclonal antibody therapies that have applied for emergency use, so we know other companies are working to meet demand, as well," she said.
The drug cocktail, named REGN-COV2, combines two monoclonal antibodies _ protective proteins that are cloned on a large scale to be identical with one another.
Experts say the treatment is likely most effective when given early in a patient's infection. It is administered by IV in a hospital.
"I wasn't feeling so hot, and within a very short period of time they gave me Regeneron _ it's called Regeneron _ and other things too, but I think this was the key," Trump said. "That's what I want for everybody. I want everybody to be given the same treatment as your president. Because I feel great. I feel, like, perfect."
But experts question Trump's conclusion that his health improvement was necessarily tied to the experimental use of Regeneron.
Dr. Anthony Fauci, the top infectious disease expert on the White House coronavirus task force, has said it could have helped the president _ but that it is impossible to say whether he would have improved on the same trajectory without using the drug.
In his video statements last week, Trump touted drugs from both Regeneron and Eli Lilly, a company producing a similar antibody cocktail treatment, as promising. But Eli Lilly has since paused its clinical trial due to safety concerns, The New York Times reported Tuesday.
"I think there is a reason we have safety and effectiveness testing in place, which is that lots of drugs that seem like they ought to work nonetheless end up hurting patients," said Dr. Theodore Iwashyna, director of health services research and a professor of internal medicine, pulmonary and critical care medicine at the University of Michigan.
"The best data show that only 10(%) to 20% of drugs that start testing ultimately are helpful. As such, I would not usually want to gamble with my patients' lives with a drug that has an 80(%) to 90% chance of hurting or not helping them, unless the patient were very, very ill," Iwashyna said.
Nevertheless, despite the lack of data, Trump said he is pushing for fast-tracked FDA emergency use authority.
"We're trying to get them on an emergency basis. We've authorized it _ I've authorized it," Trump said. "I have emergency use authorization all set, and we've got to get it signed now."
In a statement last week, Regeneron said that, "if an EUA is granted, the government has committed to making these doses available to the American people at no cost and would be responsible for their distribution."
The company has acknowledged that its CEO, Dr. Leonard Schleifer, is an acquaintance of the president, as a member of Trump's golf course in Westchester, New York.
In an interview Sunday, Schleifer said Trump's case was just one and not enough to draw a conclusion.
"The president's case is a case of one, and that's what we call a case report," Schleifer told CBS' "Face the Nation." "It is evidence of what's happening, but it's kind of the weakest evidence that you can get."
While Trump previously owned stock in Regeneron, according to a filing in 2017 with the Office of Government Ethics, those holdings did not appear on his 2020 filing.
The FDA has moved with record speed to approve emergency use authorizations for other products to help combat the coronavirus pandemic, which has taken more than 215,000 lives in the United States since February.
"The FDA has acted as quickly as they've ever acted in history," Trump said, "and no president's ever pushed them like I pushed them, either, to be honest with you."
