Ahead of President Donald Trump's Monday discharge from the care of Walter Reed Medical Center, where he had been treated for three days for symptoms of COVID-19, came a tweet.
"Don't be afraid of Covid," the president claimed, in part because the country had developed "some really great drugs."
However, the president himself — who once suggested injecting household disinfectants to treat the deadly disease — had just become one of the first 10 patients granted an extraordinarily rare level of access to an experimental antibody infusion to combat his COVID-19 infection, Salon has confirmed.
The treatment, a cocktail of human antibodies and anti-bodies cloned from stem cells, was manufactured by Regeneron. The pharmaceutical company only announced the results of a phase 1/2/3 trial on Sept. 29, or two days before the president tested positive. The treatment, which is still pending approval from the Food and Drug Administration, proved most effective for patients with weak immune systems.
Hours after receiving the treatment on Friday, Trump was flown from the White House to Walter Reed Medical Center. The White House said at the time that the president had "mild symptoms." Trump's personal physician, Dr. Sean Conley, later acknowledged that he exhibited low oxygen levels and a fever.
But Conley would not disclose the results of Trump's lung scans, only saying they showed "expected findings." Experts noted that Conley did not say the president's lungs appeared healthy, leaving open the possibility of inflammation or pneumonia.
Trump returned to the executive mansion three days later. After a balcony photo-op appearance, during which time his breathing appeared labored, the president remains at 1600 Pennsylvania Ave. Conley says Trump reports no symptoms — medically different from "showing signs," which are noticed and reported by an attending physician.
After his experience at Walter Reed, Trump declared that Americans should not let the coronavirus, which has killed more than 210,000 people in the U.S. over the last seven months, "dominate your life."
Outside of clinical trials, almost no American has access to the treatments which were available to the president. The Food and Drug Administration limits compassionate use ("expanded access") to patients with "an immediately life-threatening condition or serious disease or condition" when "no comparable or satisfactory" alternatives are available.
Patients often wait for approval, which can include an involved review and regulatory process between the patient, the physician, the pharmaceutical company and the government. Typically, companies grant compassionate use free of charge, but other monoclonal antibodies currently on the market cost thousands of dollars.
"All we can say is that they asked to be able to use it, and we were happy to oblige," Regeneron CEO Dr. Leonard Schleifer told The New York Times. Though Trump was not the first patient granted expanded access to the drug, Schleifer said, "When it's the president of the United States, of course, that gets — obviously — gets our attention."
"Presidential medicine is and has been unique," Arthur L. Caplan, professor of medical ethics at the N.Y.U. Grossman School of Medicine, told The Times. "If his doctors think an intervention might be helpful, and if that judgment is confirmed by outside experts they talk to and if things look dire or serious, then the president will get access to any and all agents."
Schleifer has been a member at Trump's Westchester, N.Y., golf club, and his company took $450 million in federal funding this summer from Operation Warp Speed, which is the administration's moonshot project to fast-track COVID-19 vaccines and treatments, according to CNN Business.
"Len and President Trump are acquaintances from both living in the Westchester area for many years but didn't have any regular contact until this year, when they've discussed matters around COVID on occasion," a Regeneron spokesperson told CNN Business.
Schleifer is an active political donor, who predominantly gives to Democratic candidates. In 2016, Schleifer gave more than $55,000 to committees supporting Hillary Clinton, but he has not yet donated to Democratic nominee Joe Biden, per FEC records. His son, Adam, lost a Democratic primary bid this summer for New York's 17th Congressional District.
"We don't share details on who has/hasn't submitted a compassionate use request, but as we've stated, only a small number of these requests have been approved for rare and exceptional circumstances, and that will continue to be the case," a Regeneron spokesperson told Salon in an email.
The spokesperson said the company was not aware of any side effects occurring in compassionate use cases and referred Salon to the FDA. The FDA did not reply to Salon's requests for comment.
In order to qualify for compassionate use, the FDA says, patients must meet a number of requirements: the disease or condition must be serious or "immediately" life-threatening; there can be "no comparable or satisfactory alternative therapy to diagnose, monitor or treat the disease or condition"; clinical trials must be out of the question; potential benefits must justify potential risks; and the treatment must not interfere with clinical trials that could support product development "or marketing approval for the treatment indication."
Given its extremely limited supply, Schleifer told CNBC that the international headlines put his company in a "very tough situation."
"Giving it to [Trump] or to others who might not be able or don't qualify for clinical trials is the right use of compassionate use. That's for small numbers of people, for these exceptions," he said. "We want everybody to be potentially able to benefit. We understand we don't make that decision. This is a decision the FDA has to make."
Through no fault of Regeneron's own, however, the company may have harnessed one of the most powerful marketing platforms on the planet — Trump's Twitter feed.
"They gave me Regeneron. It's called Regeneron," the president said in a Wednesday video published to his feed, erroneously naming the drug company instead of its treatment. "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."
Trump claimed that he had "authorized" the treatment. However, it was unclear what steps, if any, had been taken to expand its availability to more Americans.
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