Utah Went All In on Unproven Hydroxychloroquine Before Medical Experts Prevailed

Note: On Monday, May 19, after this post was written, President Trump said he’s taking hydroxychloroquine, prompting immediate criticism from a range of medical experts who warned it posed a danger to his health and set a bad example.

Even before President Trump started plugging chloroquine and hydroxychloroquine as COVID-19 treatments, enthusiasm for the old malaria drugs was swelling in the state of Utah.

The “stunning medications” led to “responses that are equivalent to Lazarus” — the biblical figure brought back to life by Jesus — one physician said at an event at the state Capitol. The deputy director of the state health department, even as he acknowledged there was not “FDA-type of evidence” showing the drugs worked, said he was willing to put stock in case reports and “test tube evidence.”

Propelled by that hype, as well as mounting fears of the oncoming pandemic, the state pursued a sweeping — and eyebrow-raising — policy that would have let pharmacies dispense the unproven medications to patients with COVID-19 without a prescription. Utah, which took perhaps the most aggressive strategy with the drugs of any state, also put in an order for $800,000 worth of chloroquine and hydroxychloroquine to build a stockpile, and considered buying millions of dollars more.

The state did all of that without any rigorous evidence the drugs can help patients recover faster from COVID-19. Clinical trials that will answer that question are ongoing, but recent observational studies have cast doubt on an effect. And in the weeks since Utah’s efforts to promote and procure the drugs, the Food and Drug Administration has warned they should not be taken for COVID-19 outside a hospital or a clinical trial, citing “reports of serious heart rhythm problems.”

Utah eventually abandoned its plans to make the drugs available without prescriptions and canceled its order.

A Drugs’ Rise and Fall

The saga of the drugs’ rise and fall in Utah, pieced together from documents STAT obtained through a public records request, provides a case study of what happens when hope and excitement about therapies outpace the evidence. It underscores the pressure officials felt to demonstrate they were on top of the response, even as such efforts sowed confusion among the medical community and led them into initiatives they came to regret. And, mirroring the hydroxychloroquine debate in the Trump administration, it shows how experts scrambled to inject restraint and plead for leaders to follow evidence at a time when promises of easy remedies were more enticing.

When, for example, the Utah Medical Association issued a bulletin to physicians, since rescinded, that suggested the state was recommending hydroxychloroquine or chloroquine for COVID-19 patients, the state epidemiologist wrote to others in the health department, “I disagree with this approach.” A top infectious disease specialist at the University of Utah was more blunt, sending a message with only “WTF?????”

In Utah, the hydroxychloroquine hype reached the public on March 20, at a press conference at the state Capitol. A group of policymakers and health professionals reassured people that they’d begun working on ways to get patients chloroquine and hydroxychloroquine. They cast their efforts as a reason for hope, while glossing over the concerns experts were raising about the medications as COVID-19 therapies. The drugs, Stuart Adams, the president of the state Senate, said, “may help bend that curve and keep people out of hospitals.”

Other speakers at the event carried the same message. Dan Richards, a pharmacist, suggested the drugs contributed to South Korea’s success in stemming its outbreak. Kurt Hegmann, a physician, made the comparison to Lazarus, and Marc Babitz, the deputy director of the state health department, delivered his comments about the quality of evidence. At one point, Babitz cited Trump as a reason for suggesting the drugs might work.

“Our president came out and suggested the medications,” Babitz said. “So we’re very confident this could make a significant difference.”

One reason why hydroxychloroquine and chloroquine attracted attention was because they were old. New drugs to fight COVID-19 would take months to develop, but these drugs had long been used to treat malaria, as well as lupus and rheumatoid arthritis. That meant that doctors could prescribe them off-label to people with COVID-19 immediately.

Driving much of the Utah officials’ interest in the drugs was Richards, the CEO of a local pharmacy chain, Meds in Motion. In a March 12 email to the executive director of the Utah health department, Joseph Miner, he suggested there was already demand for chloroquine.

Richards also suggested the state pursue a standing order, essentially a blanket prescription that would allow pharmacies to ship compounded versions of the drugs directly to patients when they tested positive for the coronavirus. He indicated doing so might help patients stay healthy enough they could avoid hospitals, at a time when a major fear of the pandemic was that it would swamp health systems.

“Utah needs this to have the potential for an epidemic curve like that for South Korea,” Hegmann, the physician working with Richards, wrote to health department leaders on March 17. (Experts say South Korea’s success in minimizing its outbreak stems not from these drugs, but from strategies like widespread testing, isolating people who are infected, and contact tracing.)

Hegmann does not appear to be an infectious disease specialist or critical care physician; his University of Utah biography says he is the chief of the division of occupational and environmental health with “expertise in musculoskeletal disorders and the evaluation of commercial drivers.” But the records indicate Hegmann and Richards were part of a public-private initiative backed by some state senators to find ways to expedite the screening of Utahns for COVID-19 and refer them to treatment; Hegmann is president of a company that was helping develop an online screening tool. (The Deseret News and Salt Lake Tribune separately obtained the records and reported on some of their contents earlier this month.)

“We are not a state-appointed, organized task force,” Richards told the Deseret News in March. “We are just a bunch of people who raised our hands and said something had to be done.”

But they quickly gained sway with the state. Hegmann, Richards, and the health department’s Miner and Babitz were soon swapping drafts and suggested edits for the standing order. A draft showed that the online screening tool would refer certain people to testing and then, if positive, to treatment with compounded hydroxychloroquine or chloroquine. The drugs, the draft said, have “the potential to help stop the spread of this virus, reduce need for hospitalization, and reduce mortality rates.”

The group thought it was a way to speed the drugs to patients, who wouldn’t need to consult with a physician after testing positive. By getting pharmacies to compound the medications, it wouldn’t cause a shortage of the versions used by patients with lupus and rheumatoid arthritis, they argued. The health department officials did not appear to raise questions about whether a pharmacist should be involved in crafting a policy that could benefit pharmacies, the records indicate.

Hegmann, Richards, and a spokesman for the state health department did not respond to emails from STAT seeking comment.

Trump Touts the Unproven Drug

Around the same time, Trump started talking up the drugs.

“Trump is touting chloroquine and hydroxychloroquine at [a] news conference right now,” Miner wrote to the group on March 19.

“That should help with community acceptance of this option,” Babitz replied. “I will say privately that I wish we had ‘trumped’ his announcement with this great plan.”

Trump’s support for the drugs came as they were being cheered on Fox News and among his political allies. Their arguments relied on results from small and flawed studies that weren’t designed to prove whether the drugs were effective or not. The view was that this was an emergency, and people couldn’t afford to wait for the results of randomized controlled trials, the types of studies that can show whether a drug works.

“What do you have to lose?” Trump said, even as federal health officials said they needed to wait on the trials results. Experts also noted that the drugs carried risks to people’s hearts.

Soon, Utah’s “great plan” was raising concerns with experts, too.

“The use of an unproven therapy in this way could be a grave mistake medically,” Andrew Pavia, the chief of pediatric infectious diseases at the University of Utah, wrote on March 22 to Miner and the lieutenant governor after finding out about the standing order.

He stressed that the state should wait for solid evidence before recommending the drugs, particularly to people who weren’t that sick. Hospitalized patients might be treated with hydroxychloroquine — cases where the potential benefits outweighed the risk — but patients shouldn’t take the medications at home without a physician’s oversight, Pavia said. “There is as yet no real evidence of clinical benefit for these drugs,” Pavia wrote. “Wide use of unproven therapies in outpatients and low risk patients exposes them to potential harm with little evidence of benefit.”

Within a few days, Gov. Gary Herbert’s office pulled the plug on the standing order, saying that there was enough capacity for people with COVID-19 to first consult with a clinician, who could decide whether or not to prescribe the medications, emails show.

But the state was not done with hydroxychloroquine. About a week later, a state purchasing agency — a separate agency from the health department — agreed to buy 20,000 packets of compounded chloroquine and hydroxychloroquine from Meds in Motion, Richards’ pharmacy, for $800,000.

State officials’ support for the drugs led to confusion — and backlash.

The clearest example: the swift reaction to a March 27 email from the Utah Medical Association to the state’s doctors, which said that Utah’s health department was “recommending that providers use a longstanding medication to treat COVID-19.” Listed were forms of chloroquine and hydroxychloroquine.

The email included suggested dosages, and added: “The state has arranged for production of compounded medication, so we do not anticipate this will cause a shortage for patients who need it for other conditions.”

Pavia, the infectious disease expert, fired off an email to Angela Dunn, the state epidemiologist who has been helping lead Utah’s COVID-19 response, that only said “WTF?????” Dunn quickly wrote to Babitz and Miner: “Do you know who put out these recommendations from UDOH?” In a follow up, she wrote, “As you know I disagree with this approach.”

It was only the beginning. “This smacks as irresponsible and even reckless,” Scott Aberegg of the University of Utah’s division of pulmonary and critical care medicine wrote to state health officials, adding there was “no credible data that support a recommendation for this drug for this indication.” He said that patients should be in monitored clinical trials if they were going to be taking the drugs.

Eventually, Babitz clarified. What happened, he said, was that he had supplied the association with recommended doses of the drugs should doctors want to prescribe them to treat COVID-19. It wasn’t meant to suggest that all COVID-19 patients get these drugs, he said.

In his explanation, Babitz spelled out a timeline of what had occurred leading up to the medical association’s email. The first bullet point: “President Trump announces to the world that chloroquine and hydroxychloroquine can combat COVID19.” He concluded: “If a healthcare provider, for whatever reason, decides s/he wishes to treat a COVID19 positive patient, our desire was to recommend the safest dosing of these medications.”

Miner emailed the head of the medical association asking for a corrected statement. “I admit there was much enthusiasm among some clinicians, pharmacists and political leaders locally and nationally about the prospects of using these medications to see if they would help blunt the severity of this pandemic,” he wrote. He added: “After further consideration we know we must have better scientific research before recommending them.”

The following day, the association sent out another email: “The UDOH has withdrawn its guidance on hydroxychloroquine from March 27. They are instead endorsing the launching of the clinical studies and urging patients to participate in the trial to get access to the investigative drugs in a controlled environment with gathering of data.”

Hydroxychloroquine and chloroquine’s moments in the spotlight did not last very long — at the national level, and in Utah.

The drugs stopped getting as much attention from Trump and Fox News. Observational studies found no benefits, and the FDA issued its warning about heart rhythm problems. Prescriptions tapered off — a relief to people who take them for autoimmune conditions.

In Utah, criticism quickly built once the state’s $800,000 purchase came to light. Some state lawmakers questioned why taxpayer dollars were being spent on unproven drugs. On April 24, Herbert, the governor, said he did not know about the initial purchase and said the health department’s talks to buy another 200,000 treatment courses from Meds in Motion had “ceased.” The Salt Lake Tribune reported the state far overpaid for the drugs compared to other formulations of hydroxychloroquine, and that the state was not experiencing any shortages.

“It was never more than a questionable COVID-19 treatment, and Utahns were never at risk of running out of it,” the Tribune editorial board wrote on April 29. “But that didn’t stop state officials from making a purchase that far exceeded any known need in the state. … State political leaders have given money and license to shameless promoters of baseless medical claims.”

That day, Herbert announced Meds in Motion refunded the state its $800,000. “A state supply of chloroquine/hydroxychloroquine is no longer prudent,” the governor’s office said.

Herbert’s office cited “breakdowns in communication between state agencies,” but there were no ramifications. “All involved acted proactively, preemptively, and prudently during an emergency in an effort to save lives,” a statement said.

As for Richards, he said his goal had always been to contribute to the state’s response.

“We did it to help the state, and it didn’t work out,” Richards told KUTV. “And we move on.”

This story was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.