The Strange and Twisted Tale of Hydroxychloroquine
The same week the mania for the drug took hold in Silicon Valley, Larry Ellison, the chair of Oracle and the fifth-richest person on earth, started talking with Donald Trump. According to The Washington Post, Ellison wanted to pitch a widespread study of chloroquine and hydroxychloroquine as a treatment. Ellison proposed that Oracle could develop a website to track people’s use of the drug along with their health outcomes, and the data would anticipate whatever a slow, expensive randomized controlled trial might eventually reveal. (Through a spokesperson, Ellison declined to answer my questions about these discussions, as did a White House spokesperson.)
Ellison seemed to make an impression. Shortly after that conversation, the Post reported, Trump met with his senior advisers on the coronavirus pandemic and asked if the government could expedite the approval process for hydroxychloroquine, chloroquine, and, for good measure, remdesivir. Emergency use authorizations had been employed during pandemics in the past, to allow treatments with potential to jump the line in times of urgent need. Remdesivir was in the midst of a large-scale randomized trial sponsored by the National Institutes of Health. Hydroxychloroquine didn’t have the same backing.
The president’s urgency wasn’t just a matter of public health. Trump had promised Covid-19 would just disappear, but the US response to the disease was going entirely off the rails. During a disastrous visit to the CDC on March 6, Trump touted his own scientific acumen—“I like this stuff. I really get it. People are surprised that I understand it”—but behind the scenes he was obstructing programs to begin widespread testing for the disease. The failure to do those tests meant that as March ticked onward, thousands of Americans were already infected. Trump acknowledged privately to the journalist Bob Woodward that Covid-19 was a dangerous, plague-level disease even as he railed against the press on Twitter and elsewhere, hoping to bolster a plummeting stock market. (“I don’t want to create panic,” he said in September when asked about why he had downplayed the severity of the pandemic.) And meanwhile every model, every infectious disease researcher, every epidemiologist was looking at case and fatality curves on the cusp of exponentiality, with worst-case fatality estimates in the millions.
A miracle cure must have sounded pretty good.
On March 19, the president conducted a press conference, and it was really weird.
This is where he started pitching hydroxychloroquine. “It’s shown very encouraging—very, very encouraging early results. And we’re going to be able to make that drug available almost immediately,” the president said. The FDA was all in too: “They’ve gone through the approval process; it’s been approved.”
This was untrue in most respects. Few results were in. The president might have meant that hydroxychloroquine was approved for malaria, lupus, and rheumatoid arthritis, and that clinicians could prescribe it off-label. He might also have been talking about Boulware’s trial, which had also been approved by the FDA. It’s certainly possible the president got confused.
The president introduced FDA commissioner Stephen Hahn, who treaded cautiously. Chloroquine was worth considering for use against Covid-19, Hahn said. “Again,” he said, “we want to do that in the setting of a clinical trial—a large, pragmatic clinical trial.”
That wasn’t what the White House was pushing for behind the scenes, though. At that same moment, the administration was allegedly pressuring Rick Bright, responsible for vaccine development as the head of the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (Barda), to get on the hydroxychloroquine train. According to Bright’s eventual whistle-blower report, the general counsel for HHS told Bright’s team that the White House wanted an Investigational New Drug protocol for chloroquine to accommodate a soon-to-come donation of millions of doses from Bayer. Bright managed to talk his bosses down to an emergency use authorization, a less full-throated support of the drug’s efficacy. “When I resisted efforts to promote and enable broad access to an unproven drug, chloroquine, to the American people without transparent information on the potential health risks, I was removed from Barda,” Bright told a subcommittee of the House Energy and Commerce Committee.
