Forget Testing, Ventilators, and PPE. Donald Trump's Big Plan to Beat COVID-19 Involved Distributing Millions of Doses of an Unproven Drug

By Katherine Eban, Vanity Fair

24 April 20

Forget testing, ventilators, and PPE. Donald Trump’s big plan to beat COVID-19 involved distributing millions of doses of an unproven drug. Behind the scenes, senior administration officials pushed hard to bend the rules and back up his boasts.

n the afternoon of Saturday, April 4, President Trump stood at the White House podium and escalated his marketing blitz on behalf of hydroxychloroquine, hyping the old malaria drug’s alleged promise in treating COVID-19, as well as his administration’s success in acquiring huge amounts of it.

“We have millions and millions of doses of it—29 million to be exact,” he said, as the official tally of COVID-19 cases in the U.S. topped 260,000 and governors across the country pleaded for federal support to acquire tests, ventilators, and protective gear for health care workers. “We’re just hearing really positive stories, and we’re continuing to collect the data.” That evening, according to emails obtained by Vanity Fair, Trump’s political appointees would ramp up the pressure on career health officials to make good on the president’s extravagant promises, despite clear warnings from federal clinicians about the risks and unproven benefits of chloroquine-based treatments for COVID-19.

Vanity Fair has assembled this account based on documents and interviews provided by multiple federal officials with knowledge of internal Trump administration proceedings.

The president had been touting hydroxychloroquine for weeks, sparking worldwide shortages of the drug and prompting negotiations with Indian prime minister Narendra Modi to lift export restrictions on its active ingredients. But on March 24, the federal government’s top interagency working group of clinicians and scientists privately threw cold water on his claims, according to a federal official with knowledge of the working group’s deliberations. In an internal consensus statement, a medical countermeasures group within Health and Human Services recommended that chloroquine-based COVID-19 treatments should be studied only in controlled, hospital-based clinical trials, as their safety and efficacy was “not supported by data from reliable clinical trials or from non-human primates” and carried “potential risks.” The medicines—which are used to treat malaria as well as autoimmune conditions such as lupus—can have serious side effects, including heart arrhythmias.

And yet, just hours after that April 4 press conference, White House officials pushed ahead with a massive behind-the-scenes pressure campaign on the government’s top health officials to deliver huge amounts of chloroquine drugs to just about anyone who wanted them, according to documents reviewed by Vanity Fair. That night, Brett Giroir, the assistant secretary for health in the Department of Health and Human Services, sent an email with the subject line “Hydroxychloroquine” to a group including FEMA administrator Pete Gaynor, HHS assistant secretary for preparedness and response Robert Kadlec, and Navy Rear Admiral John Polowczyk, who leads a supply-chain task force at FEMA.

The email read:

WH call. Really want to flood Ny and NJ with treatment courses. Hospitals have it. Sick out patients don’t. And can’t get. So go through distribution channels as we discussed. If we have 29 million perhaps send a few million ASAP? WH wants follow up in AM.

We can get a lot more of this. Right Bob? Millions per week?

The emails indicate that the administration’s top health officials were closely involved in a frenzied effort to make unproven chloroquine treatments widely available, even though the FDA’s new emergency rule limited distribution of the drug as a COVID-19 treatment to hospitalized patients. One hour after the first email, Gaynor replied to Kadlec, Giroir, and Polowczyk, seeming to suggest that FDA commissioner Stephen Hahn was on board with expanding COVID-19 patients’ access to the drug: “Hahn asked to distribute to hospitals and the drug stores.”

In a second email that appears to have been sent the same night, Gaynor indicated that he was working closely with Rear Admiral Polowczyk: “Me and Adm P are on it. More to follow in the am.”

A FEMA spokesperson did not answer questions about the involvement of Pete Gaynor or other officials in the chloroquine plan but said, “FEMA does not maintain stocks of medicine.” In response to a request for comment, an FDA spokesman responded: “Given increased demand, Dr. Hahn considered whether the donated drugs could be distributed in the commercial market to ensure a stable supply for malaria, lupus, and rheumatoid arthritis patients.”

An HHS spokesperson said that, while clinical trials of the drugs proceed, some of the government’s hydroxychloroquine “was provided to wholesale distributors to further supply hospitals as well as retail pharmacies that were experiencing product shortages for people who use the drug for the maintenance of chronic conditions such as rheumatoid arthritis and lupus.” The spokesperson added that the hospitals and pharmacies that receive donated medications are not permitted to “charge for the drug itself.”

The White House did not respond to a request for comment.

The intra–White House battle over the use of chloroquine drugs for treating COVID-19 broke into the open in dramatic fashion on April 21, when the administration’s top coronavirus vaccine developer, Rick Bright, was pushed out of his position as the head of the Biomedical Advanced Research and Development Authority (BARDA), a small agency within HHS that partners with private scientific ventures to create vaccines, drugs, and diagnostics. The next day Bright issued a statement, first reported by the New York Times, stating that he was fired for resisting efforts “to fund potentially dangerous drugs promoted by those with political connections.”

“Specifically, and contrary to misguided directives,” he said, “I limited the broad use of chloroquine and hydroxychloroquine, promoted by the administration as a panacea, but which clearly lack scientific merit.” On April 23, attorneys for Bright said they would file a formal whistleblower complaint on his behalf.

Even before Trump began making public statements from the podium, his political appointees had begun rallying around the idea of amassing chloroquine drugs to treat COVID-19, despite the paucity of evidence for their benefits. On March 18, according to records obtained by Vanity Fair, the German drug manufacturer Bayer first petitioned the FDA to let it donate millions of doses of a chloroquine drug called Resochin. Normally such a move would be prohibited since the FDA had never inspected the plant in Karachi, Pakistan, where Resochin is made. But the FDA set aside its usual safeguards and approved the donation. On March 19, Bayer issued a press release to announce that it was “working with appropriate agencies on an Emergency Use Authorization for the drug’s use in the U.S.”

The next day Trump first spoke of hydroxychloroquine from the White House podium, citing its “very, very encouraging early results. And we’re going to be able to make that drug available almost immediately.” Because the drug had “been around for a long time,” he added, “if things don’t go as planned, it’s not going to kill anybody.” Trump said he had spoken the night before with New York governor Andrew Cuomo about the drug’s promise, and “he wants to be first on line.”

Inside the administration, as the White House cobbled together a plan to make chloroquine drugs widely available to the American public, Trump’s political appointees began exerting tremendous and unwelcome pressure upon career health officials. As part of the plan, Oracle, the technology company co-founded by billionaire Trump fundraiser Larry Ellison, designed and built an app to collect data from physicians and patients tracking the response to various experimental treatments for COVID-19. (A source familiar with Oracle’s app called it “an information collector; it does not recommend therapies or treatment plans.”)

Under the plan, which set off alarm bells within the health agencies, chloroquine drugs would be available to patients through pharmacies, not just to hospitalized patients. “There wasn’t a plan for physician oversight or monitoring,” one federal official told Vanity Fair. “That’s what concerned clinicians the most. Career FDA, NIH, CDC, and BARDA [personnel] were all very concerned about lack of physician oversight or adverse event monitoring with the expanded-access program.”

On the evening of March 23, the FDA’s chief counsel, Stacy Amin, emailed lawyers and other officials within HHS, the National Institutes of Health, and the FDA, urging action to set the plan in motion. The idea, as she spelled it out, would be to have BARDA sponsor what is called an investigational new drug study. An IND permits a new drug in preclinical development to be shipped across state lines to be studied. In this case the IND would have covered an old drug with a potential new use. Amin, who served as a special assistant to President Trump before assuming her current role at the FDA in September 2018, wrote, “The President is announcing this tonight and I believe the WH would like it set up by tomorrow with data to flow into the Oracle platform.” She then asked, “What needs to be done and what requirements do we think can be waived or use enforcement discretion?”

According to the FDA’s spokesman, “The FDA, including Ms. Amin, has discussed and explored various ways to collect this data but ultimately did not support doing it through an IND and has not waived any regulatory requirements in connection with this or other related efforts.”

The order to implement such a complex and unorthodox plan on a timetable driven by the president’s press announcements stunned numerous BARDA employees. Within hours, one official wrote to a colleague, “We have been hit by a bus. Now we hit back.” He said he would try to amend the proposal and find a “workable” solution.

Days of debate ensued as employees within the agency pushed back.

By late March, health officials across multiple agencies had settled on an alternate plan, which they viewed as safer for patients. On March 28, the FDA issued an emergency use authorization (EUA) to allow chloroquine drugs from the Strategic National Stockpile to be administered to hospitalized COVID-19 patients who could not access clinical trials. The stockpile is a cache of equipment and supplies managed by HHS that can be accessed in the event of medical emergencies.

In the statement related to his firing, Rick Bright seemed to refer to that authorization when he wrote, “I rightly resisted efforts to provide an unproven drug on demand to the American public. I insisted that these drugs be provided only to hospitalized patients with confirmed COVID-19 while under the supervision of a physician.”

But top officials were not satisfied with the more restrictive approach and kept pushing for more widespread distribution of the drug. In an email that appears to have been addressed to Gaynor at some point after the emergency use authorization was issued, Brett Giroir argued strongly against limiting the drugs to hospitals. “NOPE. Needs to go to pharmacies as well,” he wrote. “The EUA matters not. The drug is approved [and] therefore can be prescribed as per doctor’s orders That is a FINAL ANSWER.”

Giroir’s rationale for ignoring FDA limitations appeared to hinge on a technicality: Because chloroquine is FDA-approved for conditions including malaria and lupus, doctors could technically prescribe it for any “off-label” treatments they saw fit. He added, presumably in reference to shortages prompted by Trump’s P.R. campaign, “And pharmacies need it for ON LABEL use as well.”

According to Dr. Adarsh Bhimraj, head of the neurologic infectious diseases section of the Cleveland Clinic, the impulse to rush untested medicines to patients is understandable but unwise. “These people are sick. We want to do something,” he said, drawing on his own experience treating patients with COVID-19. Nevertheless, he added, “It’s important as clinicians that we step back, reflect, and pause. Let’s look at the evidence before we prescribe any medications.”

Dr. Bhimraj chaired the panel for the Infectious Diseases Society of America that recently issued treatment guidelines stating COVID-19 patients should only get treated with chloroquine drugs in hospital-based clinical trials. Based on the human data so far, he said, “We don’t know if the benefits outweigh the harm,” and only “double-blinded, placebo-controlled studies” can answer that question.

As HHS prepared to announce donations of chloroquine to the Strategic National Stockpile, and chalk up a “win” for the White House, safety concerns dogged the plan.

The FDA’s chief of staff, Keagan Lenihan, emailed Amin to warn that after the chloroquine pills donated by Bayer arrived at John F. Kennedy International Airport in New York, they would need to be quarantined and tested. “If it is the product we think it is and it is not toxic we will release it” to the office that oversees the national stockpile, Lenihan wrote. “Apparently, where Bayer is getting this product from is a manufacturing facility they use for Africa.” In fact, the facility in question is used to supply the Pakistan market, and has been inspected by Pakistani regulators, not the FDA. Lenihan continued, “Potentially serious issues with product so let’s be careful when we take that win.” Bayer has previously pointed out that the FDA tested Resochin “and found it to be of appropriate quality for release to the (stockpile) for emergency use.”

As health officials navigated a minefield of long-standing regulations that were impeding the White House campaign, the message from the presidential podium was exultant: Trump had zeroed in on a potential cure and had slashed red tape to speed it to patients in need. On April 4, the president declared that the tech giant Oracle had donated a “very sophisticated” web portal to gather real-time data on how patients were responding to the new treatments.

Since then, a steady drumbeat of small-scale studies and medical recommendations has cast increasing doubt on the treatment that Trump once hailed as a “game changer.” On April 21, a study of 368 COVID-19 patients at veterans hospitals showed that about 28% of those treated with hydroxychloroquine died, compared with 11% of those who didn’t receive the medication.

On the same day the National Institutes of Health issued detailed treatment guidelines, stating, “There are insufficient clinical data to recommend either for or against using chloroquine or hydroxychloroquine for the treatment of COVID-19.” The agency advised clinicians using the drugs to closely monitor patients for adverse effects, particularly cardiac risks.

Whether owing to the accumulation of evidence against hydroxycholoroquine’s efficacy, the resistance of career health officials, or something else entirely, the Trump administration appears to have dropped its crusade on behalf of the purported miracle cure—at least for now. It’s been over a week since the president last used a daily coronavirus briefing to promote the drug. This week, the U.S. death count from COVID-19 is expected to pass 50,000.