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When, for example, the Utah Medical Association issued a bulletin to physicians, since rescinded, that suggested the state was recommending hydroxychloroquine or chloroquine for COVID-19 patients, the state epidemiologist wrote to others in the health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.