- President Donald Trump and former New Jersey Gov. Chris Christie's access to experimental Covid-19 treatments raises ethical questions, bioethicists say.
- It can influence the public's perception of a drug ahead of robust clinical trials.
When President Donald Trump confirmed Oct. 2 that he was diagnosed with Covid-19, he received a cocktail of therapies — some of which hadn't yet been approved for general use.
Likewise, former New Jersey Gov. Chris Christie, a close ally of Trump's, received remdesivir as well as an experimental antibody treatment from Eli Lilly when he was diagnosed with the virus that same week. Both Trump and Christie were suspected of picking up the virus at the Sept. 26 Rose Garden press conference at the White House announcing Amy Coney Barrett's pick for the Supreme Court — a ceremony later characterized as a "superspreader" event.
Gilead, Lilly and Regeneron's drugs weren't available to the general public at the time. To access two of the drugs, both men applied for and were granted special exemptions as part of an FDA program that gives patients limited access to investigational medical products before they're approved. A so-called "compassionate use" exception can be granted by a drugmaker on a limited basis if a disease is life-threatening and there are no other clear treatments.
The swift approval to use the drugs to treat Trump and Christie exposed very clearly that some Americans with power and money are getting very different access to treatments and health care than everyone else, physicians say.
Pharma companies don't freely grant compassionate use requests for their drugs. The upside is limited, but the downside is substantial if the patient dies or suffers from a horrible side effect. But in the case of the president and his allies, drug companies have been more willing to OK the requests. As Regeneron's CEO Dr. Leonard Schleifer told the New York Times: "When it's the president of the United States, of course, that gets — obviously — gets our attention."
Trump received Regeneron's experimental antibody treatment REGN-COV2 immediately after he started showing symptoms on Oct. 1, said Dr. Brian Garibaldi, a physician with Johns Hopkins' biocontainment unit who was assisting the White House at the time.
"Very few patients" have been given the drug under compassionate use, a Regeneron spokesperson said in an email. "Given the limited supply and ongoing clinical trials, that is not intended to be the main mechanism of access and thus is only granted in very rare and unusual circumstances."
Bioethicists say that granting the elite access to treatments that are out of reach for ordinary Americans is nothing new. And it's not altogether surprising Trump was prescribed Regeneron's drug, given that it had passed safety trials. But they still shared concerns about the message it sends and the broader implications.
"A system where only those with means have access to these therapies flies in the face of our understanding of medical justice," said Dr. Vinay Prasad, an associate professor of Medicine at the University of California San Francisco, who studies health policy. "We've ended up with a situation where the politicians who are getting blamed for mismanaging the pandemic have saved themselves a parachute."
There are particular concerns among the bioethicists related to Christie's case. Patients must meet several criteria to qualify for expanded access, including that they're unable to enroll in a clinical trial.
BioCentury, a trade publication, reported that Christie was offered an opportunity to enroll in a clinical trial for Regeneron's drug since his hospital was participating in the trial. But the publication said Christie, who was admitted to the hospital Oct. 3 with Covid-19, declined to participate in the trial, because he feared that he might be placed in the placebo group. Instead, he received remdesivir and Lilly's antibody cocktail bamlanivimab as part of its expanded-access program.
Lilly spokewoman Molly McCully declined to comment on Christie's case.
"As a matter of policy, Lilly does not comment or speculate about individual patient information," she said in an email to CNBC. She added that the company is willing to consider individual patient expanded access for its antibody therapy on a case-by-case basis.
That can send a negative message to the public about clinical trials, making it even more challenging than it already is for pharma companies to enroll participants.
In reality, the majority of experimental medical products are rejected by the FDA, so patients receiving the placebo might be better off than their counterparts who receive the drug.
Bioethicists say that's just one of the risks associated with rolling out the red carpet for the rich and famous. For starters, the public might come to a premature conclusion about a drug that can be challenging to walk back. It could also pressure regulators to approve a drug before there's enough data supporting that decision, they said.
"The president essentially became a walking ad for Regeneron," Prasad explained.
Likewise, earlier this month, Christie received the Lilly treatment before announcing to the press that he had improved enough to leave the hospital. That may have heightened the public's expectations that a cure is on the horizon.
Lilly said on Oct. 26 that a clinical trial showed its antibody treatment bamlanivimab was ineffective in hospitalized patients. The treatment is also difficult to administer. It's given to Covid-19 patients via an IV infusion that takes more than an hour and requires another hour of observation afterward, the company said. Lilly said in a statement that it's now testing the antibody drug in mild to moderately ill patients who seem to respond better to the treatment than more seriously ill people.
Still, the Food and Drug Administration approved the use of bamlanivimab on an emergency basis on Monday. It also granted full approval to remdesivir, under the name Veklury, on Oct. 22. Regeneron applied for emergency use approval for its Covid-19 treatment on Oct. 7.
Doctors working with Covid-19 patients across the socio-economic spectrum say their patients are asking why they don't have access to these treatments.
"When I'm managing my patients, most of who are sick but not at the hospital, almost every single one of them asks if they'd be treated differently if I were the president," said Dr. Panagis Galiatsatos, a pulmonary and critical care medicine physician based in Baltimore, Maryland. "We have supportive therapy and no cure, but our patients think we are keeping treatments from them."
Texas-based gastroenterologist Yamini Natarajan said for the sickest patients in intensive care, it can be difficult to understand why they don't get the same treatments as those they see in the news. "There's a lot of interest in Regeneron and hydroxychloroquine," she said. Dr. Natarajan said her patients understand, once she explains the risks associated with unproven medicines.
Those who treat uninsured patients like Dr. Kris Sargent, a rural family medicine doctor currently based in Alaska, said it's standard practice in the U.S. to treat some patients better than others.
"We have long had issues with different levels of medical care being available based on income," he said. But he cautions his own patients that more care, including VIP care, isn't necessarily better. It's something he, and many other physicians, consider if they get sick. "Treat me like any other patient is our usual mantra," he said.
For Arthur Caplan, a professor of bioethics at New York University Langone Medical Center, there are other considerations. What if a famous patient involved in an expanded access program deteriorated, or even died, in the public eye, he asked. What if something else made that patient worse, but the drug could have been extremely effective for millions of other people, he challenged.
"The public could lose out on a valuable drug if the outcome is bad and it's highly visible," said Caplan. "Investors might back away from that drug, even if it's an unusual case."
In Caplan's view, celebrities should clearly acknowledge when they receive special treatment. If those in power receive drugs that most Americans can't access, their experience won't be comparable to others.
"I'm very disappointed that the president didn't come away from this saying that he had access to top-flight care and that many millions of Americans without health insurance do not," he said.
Going forward, medical experts stress that the reality is that Covid-19 is still a threat for many Americans. And disproportionately, that's impacting our most vulnerable who do not yet have access to health care at all — let alone experimental drugs and vaccines.
"When you give health insurance to people, they live longer," says Dr. Zeke Emanuel, a bioethicist and oncologist who's advising President-elect Joe Biden on the pandemic. "Covid-19 has exposed the disparities based on income and race, but those disparities have existed for a long time."