“All this buzz is confusing the American public,” said one senior Health and Human Services official involved in drug policy.
President Donald Trump’s all-out push to advance unproven coronavirus treatments is deepening a divide between the White House and career health officials, who are being pulled away from other potential projects to address the president’s hunch that decades-old malaria medicines can be coronavirus cures.
The White House directed health officials to set up a project to track if the antimalarial drugs chloroquine and hydroxychloroquine show promise — a dayslong effort that distracted from urgent tasks like trials of other medicines thought to have more potential against the virus. Food and Drug Administration officials also reversed a nearly six-year ban on a troubled Indian manufacturer in a bid to secure the drugs, and top advisers to Trump have encouraged other agencies to locate as much of the product as possible. The White House is also pressuring Medicare officials to pay for unproven treatments being given to desperate patients during a pandemic.
“Everyone is getting ahead of their skis here,” said one senior Health and Human Services official involved in drug policy. “All this buzz is confusing the American public, it’s confusing doctors. There’s a ton of people involved in front-line response in the government … who are getting pulled into meetings to discuss this when the data doesn’t support it.”
This is “mindshare, time and energy being soaked up by a potential wild-goose chase,” said a second senior HHS official working on the coronavirus response. “We have no idea if this works, and the evidence suggests it doesn’t.”
Trump began championing two decades-old malaria medicines last week after a phone call with Oracle co-founder Larry Ellison, a top Trump campaign donor. Ellison offered to build the government a database to track off-label prescriptions of chloroquine and hydroxychloroquine, which had spiked by 7,000 percent after anecdotal reports that the drugs could aid coronavirus patients.
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Now, according to Agus and HHS officials, the White House has pulled multiple health agencies — including the Food and Drug Administration, the National Institutes of Health and the Centers for Medicare and Medicaid Services — into a project to develop a database tracking the drugs’ use against the coronavirus, despite scant evidence that they are effective. The White House is having second thoughts about working with Oracle on the project after a New York Times article this week raised questions about the partnership, said two HHS officials.
In the meantime, the FDA this week lifted years-old restrictions on India-based Ipca Laboratories, a manufacturer of hydroxychloroquine and chloroquine, in a bid to get more of the drugs. Agency inspections in 2014 had uncovered “cascade of failure” at the company’s plants, including data manipulation. Two FDA officials said they were uneasy about the sudden reversal.
The White House also has ordered CMS, which oversees Medicare, Medicaid and the Affordable Care Act, to explore how to reimburse doctors for prescribing chloroquine to patients searching for a coronavirus treatment, said two officials with knowledge of the agency’s strategy. The prospect of CMS payments to doctors for handing out unproven treatments raises immediate ethical questions, say bioethicists and health officials.
“They’re basically creating a perverse incentive for physicians to use an unapproved therapy,” said one official.
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The White House has also directed FEMA to locate as much of the drugs as possible, pulling officials away from the agency’s ongoing effort to lead the federal coronavirus response, said two people with knowledge of the agency’s planning.
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Fauci drew a clear line the next day, even as the president pushed back. “You have to be careful when you say ‘fairly effective.’ It was never done in a clinical trial. It was given to individuals who felt that maybe it worked.”
“I’m a smart guy. I feel good about it,” Trump said. “Let’s see what happens. We have nothing to lose.”
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“The real problems are not trying to find a magic bullet,” said bioethicist Caplan, whose university in New York City is now surrounded by the outbreak. “I wish the administration would figure out how to get equipment and protective gear to places where the outbreak is the worst. If we had testing, it would do far more than figuring out whether this malaria drug can kill the coronavirus.”
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President Trump’s all-out push to advance unproven coronavirus treatments is deepening a divide between the White House and career health officials https://t.co/ee4AAiGFe5
— POLITICO (@politico) March 27, 2020
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