Nonetheless, patients are clamoring for the medications, in part because of Trump’s comments, as well as testimonials from Housing and Urban Development Secretary Ben Carson and former New Jersey governor Chris Christie, who also got the drugs before they were approved.
“Frankly, the image of Trump coming out of Walter Reed and being better so quickly, I think it really gave a lot of people a false sense of security regarding what a treatment can do,” said Jeanne Marrazzo, director of the division of infectious diseases at the University of Alabama at Birmingham. “The reality is, people who have extra access to the latest and greatest treatments are not your average person. . . . People don’t realize how inaccessible these drugs are.”
In some ways, the story of the antibody treatments is the tale of the U.S. health-care system, which tends to cater to the well-insured and well-connected, especially in providing new treatments.
Scarce supplies also are a defining theme of the pandemic, as shortages of coronavirus tests, personal protective equipment and toilet paper have forced rationing until production catches up. That trend will continue with coronavirus vaccines, which are likely to come online next month.
In the case of the antibody drugs, they are complicated to make because they are created by live cells. The manufacturing process can’t be rushed. And the drugs must be administered intravenously, creating challenges for health facilities that must set up separate infusion centers so patients with cancer and autoimmune disorders aren’t exposed to people who are infected.
Trump received his treatment Oct. 2, shortly before he was taken to Walter Reed National Military Medical Center. Christie, who days before had helped prepare Trump for the first presidential debate, became seriously ill and received the Lilly drug while hospitalized.
Carson received the Regeneron drug more recently, as an outpatient at Walter Reed. In a Facebook post Friday, he said he had been “desperately ill” with covid-19 and that Trump “cleared me for the monoclonal antibody therapy that he had previously received, which I am convinced saved my life.” The retired neurosurgeon said he realized he had access to a level of medical care most Americans do not, and added that such care should be available to everyone. A HUD spokesman declined to comment.
Carson, Christie and Trump all got the drugs under “expanded access” programs before they were authorized by the Food and Drug Administration.
Health experts worried their experiences would give Americans the wrong impression about the drugs’ availability.
“The president will not be calling Regeneron so that your grandmother can receive the therapy,” Walid Gellad, director of the University of Pittsburgh’s Center for Pharmaceutical Pharmaceutical Policy and Prescribing, wrote in an email. “I don’t know to what extent the public understands how limited these therapies will be initially.”
In addition, the drugs are not suitable for people who are severely ill. Several weeks after Trump got the treatments, studies showed that the medications don’t help hospitalized patients, and might even harm them. When the FDA cleared the drugs, the agency stipulated they were for patients with mild to moderate cases who are at high risk for serious illness because of age or medical conditions such as obesity or diabetes. The goal is to keep those patients out of the hospital.
Several other people in Trump’s orbit also have had covid-19 and were offered help getting access to the drugs.
One adviser who contracted the virus said the president offered to get the Regeneron drug for him. “It’ll make you better overnight,” the president said, according to a person who spoke on the condition of anonymity because of the sensitive nature of the information. But the adviser demurred, saying he did not need it.
Ronna McDaniel, chairwoman of the Republican National Committee, and Mark Meadows, Trump’s chief of staff, also tested positive but didn’t need the antibodies, officials said.
After the president’s hospitalization, some advisers also warned him against speaking about the coronavirus as if it were a small inconvenience after he had benefited from experimental drugs unavailable to others. Trump’s response was that he wanted to make a video telling the American people that they’d get the drugs, too, though the White House had no ability to ramp up production.
Trump did call Regeneron chief executive Leonard Schleifer to ask about expediting the wider distribution of the drug, according to a person with knowledge of the calls who spoke on the condition of anonymity because he was not authorized to talk about the issue.
White House spokesman Brian Morgenstern said in a statement that “as a bridge to safe and effective vaccines just weeks away, the Trump administration’s Operation Warp Speed is working with private sector innovators to distribute hundreds of thousands of doses of these critical antibody treatments every single month to save lives.”
A Regeneron spokesperson said the company “has worked extremely hard over the last several months to invent, test and maximize production of our antibody cocktail in record time. Even so, we recognize demand may exceed supply initially, making it even more critical that federal and state governments ensure the antibody cocktail is distributed fairly and equitably to the patients most in need.”
Despite the difficulties in getting the antibody drugs, doctors said they were happy to have another tool for treating a disease that has few effective treatments.
“We are excited about it,” said David Aronoff, director of the division of infectious diseases at Vanderbilt University Medical Center. He said the challenge is making sure the drugs get quickly to those at highest risk for hospitalization. “There may be very high demand that will outstrip supply,” he said.
The Regeneron medicine is a combination of two monoclonal antibodies, called casirivimab and imdevimab, which are proteins created in the laboratory to mimic the human immune system. It works by imitating the body’s natural defenses instead of waiting for the body to mount its own response. The Lilly product is a single antibody, called bamlanivimab, that operates in a similar way. The drugs make it harder for the coronavirus to infect human cells.
Operation Warp Speed, the administration’s effort to speed coronavirus treatments and vaccines, provided hundreds of millions of dollars for the drugs’ development and bought 300,000 doses from each company, with the option of purchasing hundreds of thousands more. It has begun allocating them to states based on their number of cases and hospitalizations for broad use.
Both companies are ramping up production. Lilly, for example, expects to have 1 million doses by the end of this year.
But for now, as cases surge, supplies are limited, upsetting doctors looking to keep patients out of overcrowded hospitals.
Outside of clinical trials, for example, the University of Alabama at Birmingham as of Tuesday had 20 doses of the Lilly drug for outpatients and no doses of the Regeneron drug, according to Marrazzo, in a state averaging more than 2,000 new infections a day.
Finding the right patients isn’t easy, either. They need to have recently tested positive for the virus but be within 10 days of showing symptoms, according to the FDA authorizations.
Patients who qualify for the drugs will need to come to outpatient centers for infusions before getting seriously ill, which makes them no longer eligible. “In the past, we were telling people not to come into the hospital, to stay home,” said Rajesh Gandhi, an infectious-disease physician at Massachusetts General Hospital and Harvard Medical School. “Now we will be sending the opposite message.”
Besides setting up separate infusion space, hospitals and clinics also are trying to figure out how to staff the administration of the drugs. Though the infusion itself takes only one hour, the entire episode, including an extra hour for monitoring a patient for side effects, can easily take three hours.
Those additional staffing needs are occurring as some facilities approach a breaking point, with cases surging and staff extremely stretched. Some say providers should explore delivering the drugs in people’s homes.
Vanderbilt’s Aronoff said the FDA’s “at risk” category is so broad that the hospital has had to narrow the criteria to avoid quickly running out of drug supplies. “We tightened up, not because we don’t think everyone is deserving, but because we just don’t have much of the medication,” he said.
For Marrazzo at the University of Alabama, the rationing decisions are excruciating.
“If I have five doses and 20 patients who need it, how on earth do I decide?” she said. “Do I choose the young physician who has diabetes? Or a 71-year-old who is at risk because of his age? Deciding how to do it becomes arbitrary.”