It turns out that when the President of the United States contracts a virus which has killed more than a million people around the world—more than 200,000 people in America alone—he can get some special treatment. Literally.
The debacle of President Trump’s COVID diagnosis and a cascade of revelations that multiple GOP elected officials and, potentially supporters who have attended events, have contracted coronavirus is a dizzying story. The President’s own physician, Dr. Sean Conley, delivered a press conference Saturday morning which raised more questions than it answered about Trump’s health after he was airlifted to the Walter Reed medical center on Friday.
The timeline Conley provided didn’t match up with what the White House had previously said, and he later provided a statement saying he misspoke. According to the latest information, Trump was diagnosed on Thursday and did not begin receiving an experimental COVID drug from Regeneron, an antibody cocktail, until Friday.
Additionally, he’s receiving Gilead’s remdesivir, which has gained Food and Drug Administration (FDA) emergency authorization for some of the sicker COVID patients and is an experimental antiviral that’s been in development to attack infectious diseases for more than a decade (and has been used on many patients already). On Sunday, it was unveiled that he’s also on dexamethasone, a decades-old steroid which attacks inflammation and has typically been used on patients with serious cases of COVID-19.
Trump’s access to the experimental Regeneron drug cocktail, a more unique therapeutic without the emergency designation, speaks volumes about the state of drug regulation. The treatment, like Eli Lilly’s similar therapy, could very well receive FDA emergency authorization in the future, although it hasn’t to date.
How exactly did he get it then? Trump has always been a proponent of “right-to-try” drug laws—wherein sick patients can receive unapproved therapies if there’s simply no other option.
But what happened here is different. The President was directly cleared by the FDA to get the Regeneron drug under the agency’s expanded access program.
“Right-to-try is similar to expanded access, however, the primary difference is FDA permission for use is not required,” as one industry group explains.
The FDA had to grant specific permission for Trump himself to receive the Regeneron treatment. The company’s CEO, Leonard Schleifer, said as much in an interview with the New York Times. “All we can say is that they asked to be able to use it, and we were happy to oblige,” he said. “When it’s the President of the United States, of course, that gets—obviously—gets our attention.”
Expanded access isn’t unique to the President. Thousands of patients with debilitating diseases who have a dearth of available treatment options use that process every year. But in this case, it appears that Trump had a straight line to that access on top of some of the best medical care in the country.