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Gov. Gary Herbert on Friday said state officials will not be buying any more malaria drugs after the Food and Drug Administration cautioned against administering the unproven medication for coronavirus to patients outside of a hospital or clinical trial.
Addressing the media, Herbert also said the state’s initial $800,000 purchase of the drugs — hydroxychloroquine and chloroquine — happened unbeknownst to him and that he was looking into how the transaction transpired.
“I have some questions about how this came about, the transparency,” Herbert said. “The situation in its entirety is now under review by our legal counsel.”
A day earlier, the Utah Department of Health released a statement saying it was still exploring a massive purchase of hydroxychloroquine from an in-state pharmacist who has amassed the drug. The contract has not been signed, but lawmakers in recent days have passed legislation carving out $8 million to stockpile medication.
For critics of the deal, the new Food and Drug Administration (FDA) advisory underscored the arguments they’ve been making — that the state should not spend public money on an unproven and potentially dangerous treatment.
“This is an irresponsible use of taxpayer dollars. This FDA statement today makes it clear that these medications are not without risk,” said Rep. Suzanne Harrison, D-Draper, a physician anesthesiologist and immediate past president of the Salt Lake County Medical Society. “We all want a cure for this virus, but we can’t let wishful thinking get ahead of good medicine.”
The FDA’s advisory emerged from a review of medical literature, case reports and data from the American Association of Poison Control Centers, which showed that some coronavirus patients are experiencing serious heart rhythm problems after taking the malaria drugs.
“[W]e would like to remind health care professionals and patients of the known risks associated with both hydroxychloroquine and chloroquine,” the FDA advisory stated. “Hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing COVID-19.”
The state’s plan had been to buy medication for up to 200,000 patients from a drugstore chain called Meds in Motion and distribute it to pharmacies across Utah. The drugs would then be available for free to patients with a prescription showing they have an active case of coronavirus, state officials have said.
While health officials in recent days emphasized that they hadn’t yet inked a deal with Meds in Motion, information surfaced Thursday showing the state has already ordered 20,000 doses of hydroxychloroquine and chloroquine from the company. The $800,000 acquisition in late March happened outside the state’s regular procurement process, instead following emergency rules that allow for no-compete purchases, according to the state’s director of purchasing and general services.
Lawmakers this week said the state bought the medication after federal officials had warned them about potential shortages of the drug, which is often prescribed to people with rheumatoid arthritis and lupus.
Herbert on Friday said he wasn’t apprised of the purchase at the time and told reporters that the order hasn’t yet been delivered to the state. He floated the idea that officials could request a refund for the 20,000 doses from Meds in Motion.
“That’d be nice if they just said, you know, we had a miscommunication here and we’re apologizing and here’s your money back," he said. “I think everybody dealt, at least on our side of the equation, in good faith. I think they were trying to find a way to alleviate suffering, to find maybe hope to help people that had COVID-19 to recover. I don’t think anybody was doing anything other than trying to find a way to solve a unique problem we had never seen before.”
In a prepared statement, Herbert’s office said the Governor’s Office of Management and Budget (GOMB) had been authorized in the early days of the pandemic to make “rapid-fire decisions” about purchases in support of the COVID-19 effort. The Meds in Motion deal was one of these decisions, according to the office.
A GOMB spokesman declined to answer questions about the transaction Friday because the contract is under review.
During his news conference, Herbert also addressed questions about the appearance of hydroxychloroquine-related questions on TestUtah.com, a website promoted by Silicon Slopes to identify Utahns for coronavirus testing. Herbert said queries related to the malaria drug were inappropriate and would be removed from the questionnaire.
So far, Utah drugstores haven’t reported problems keeping the medication in stock, according to Adam Jones, executive director of the Utah Pharmacy Association.
“I would suspect that we’re still in pretty good shape,” Jones said this week.
On Thursday, state health officials released a statement that suggested the threat of a shortage might be subsiding.
“The most consistent element of COVID-19 has been that things are constantly changing,” said Jeff Burton, acting executive director of the Utah Department of Health. “We wanted to put ourselves in a position that if there were to be a shortage in the supply chain of hydroxychloroquine we were well-positioned to be able to provide medication to Utah residents who need it. The good news is, the supply chain has recently shown signs of stabilization.”
Rep. Ray Ward, another physician who serves in the Legislature, says he doesn’t understand why the state would insert itself into the drug supply chain or invest in medication that hasn’t been proven to help coronavirus patients. As lawmakers this week reserved millions of dollars for stockpiling drugs, the Bountiful Republican urged them to restrict the funds to purchases of medication for their FDA-approved uses.
His colleagues narrowly rejected the amendment after arguing these limitations might inhibit them from reserving medication while it’s still available.
Ward said he would not prescribe hydroxychloroquine for his patients and aligns with the FDA statement discouraging use of the drug outside of a clinical trial or a hospital.
“If we’re just giving it helter-skelter, two months from now, we still won’t know if the benefit outweighs the risk,” he said.
Intermountain Healthcare and University of Utah Health are currently leading a pair of clinical trials on hydroxychloroquine, one to study its effect on hospitalized coronavirus patients and the other looking at its impact on people who are recovering from COVID-19 at home.
Dr. Brandon Webb, an Intermountain infectious disease specialist who is helping lead one of the trials, said Utah researchers have observed some cardiac rhythm issues in hospitalized patients, whose hearts are already weakened by COVID-19. In the outpatient trial, he said, researchers have so far not seen these problems develop, but he noted that investigators are screening out people who are at higher risk of developing heart arrhythmia.
“We remain committed to protecting the safety of patients, and we view clinical trials as the optimal method for doing that, because not only do clinical trials answer the question [of whether the drugs benefit coronavirus patients], but they provide robust safety monitoring methods,” he said. “And they allow us to carefully select patients to participate because they are at low risk of having these complications.”
Tribune reporter Jessica Miller contributed to this report.