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State leaders who want to buy a stockpile of malaria drugs for the coronavirus are digesting a new study that demonstrated no benefit — and suggested some possible dangers — in using the medication during the pandemic.
But Jeff Burton, who’s heading the coronavirus response at the Utah Department of Health, says they’re unlikely to reconsider the purchase.
“At this point, there would have to be a lot more information to come in that would cause us to not want to proceed,” Burton said Wednesday in a phone interview.
Utah officials haven’t finalized the deal to buy medication for up to 200,000 coronavirus patients but want to distribute the huge supply of drugs to pharmacies across the state, according to representatives of the Utah Department of Health. The medication would be available for free to patients with a prescription certifying they have an active case of COVID-19.
However, the value of the medicine in combatting the virus is in doubt.
On Tuesday, news broke about a study of 368 Veterans Affairs (V.A.) patients with coronavirus found that those who took the medicine, hydroxychloroquine, had higher rates of death than those who did not. There was no apparent benefit from the drug.
It was not a rigorous experiment and hasn’t been peer-reviewed. However, according to the Associated Press, the study is larger than others that have attempted to explore the drug’s potential for treating COVID-19.
Burton said he wonders what underlying conditions the patients in the study had and how those might have influenced its outcome. The answers to those questions and results from other ongoing clinical trials could shift perspectives about the drug’s place in the pandemic, he said.
“As everyone knows, this drug has not been particularly proven for treatment for COVID-19. There have been some positive indicators that it might be helpful," he said. “But as a state, obviously, we want to make sure we’re not late to have what our citizens need.”
The question of how to use the unproven drugs has become a politically fraught one, with President Donald Trump promoting the medication as a potential “game changer” despite a lack of supporting evidence. Believers in the remedy’s promise point to small studies out of France that suggested the medication might improve outcomes for COVID-19 patients.
However, scientists internationally have found fault with the methodologies used by the French researcher, and other studies have produced conflicting results — one small study in Brazil was even terminated out of concern over potentially dangerous heart complications.
In the V.A. study, death rates stood at more than 27% for patients treated with hydroxychloroquine alone and about 22% for those who received hydroxychloroquine in combination with the antibiotic azithromycin, according to the Washington Post. By comparison, only about 11.4% of those who did not receive hydroxychloroquine died.
Utah health officials in March asked two medical experts for advice about stocking up on hydroxychloroquine, and both discouraged the purchase, saying there is no solid evidence of its effectiveness in combatting the virus.
“There is no rationale for the state to expend precious resources to purchase additional supplies of these drugs,” Andy Pavia, pediatric infectious diseases chief at University of Utah Health, wrote to state health workers in an email obtained by The Salt Lake Tribune. “If they do prove effective, there are pathways to obtaining supplies if we exhaust our current supplies.”
Moreover, several clinical trials in Utah are already offering access to the medications “in a setting where patients will be carefully monitored," he added.
Burton said a range of health care professionals were consulted about the purchase of malaria drugs and that opinions differed.
“You’ve got people on both sides of this issue, and we understand that, but the government doesn’t want to be late to need,” he said.
The retired general said he doesn’t know how Utah officials established a relationship with Meds in Motion, the pharmacy interested in selling its large supply of hydroxychloroquine to the state. The initial contact happened before Burton began leading the task force in late March, he said.
At the time the state and business connected, he said, there were concerns about a potential explosion in demand for hydroxychloroquine, which is also often prescribed for lupus and rheumatoid arthritis. As officials sought to protect Utah’s supply, they found a pharmacist who was willing to put “a lot of capital forth” to import the drugs’ raw ingredients, he said.
The compounding pharmacy is preparing a formulation of hydroxychloroquine and zinc, which will be encapsulated and then sold to the state, according to Burton. But before the state seals the deal, it’s waiting on an independent laboratory to verify the quality of the ingredients.
“Obviously, we wouldn’t purchase anything not clean and pure,” he said.
Burton said he doesn’t know the name of the independent lab that’s currently checking the materials.
The size of the purchase — enough medicine for up to 200,000 people — is based on models predicting there would be a demand for drugs to treat between 50,000 and 400,000 coronavirus patients, he said
State officials do have a budget for the project to buy the medicine and distribute it to pharmacies across the state, but Burton said he didn’t want to disclose these numbers before the contract with Meds in Motion is signed. A combination of state and federal funds will cover the acquisition, he added.
Utah House Democrats on Tuesday released a statement expressing concern over the planned transaction, mentioning the VA study as clear evidence that more research is needed on the drugs’ safety as a COVID-19 treatment.
“Pharmacists report no shortages for patients who actually need the medicine. It is also not clear how the decision to use state money was made, or where the money is coming from,” the Democrats said in their statement. "We agree that some people should have access to experimental drugs when no other options exist. However, using millions of dollars of taxpayer money to purchase a drug that has not been proven to help COVID-19 sufferers seems designed to make money, not to heal.”
Utah lawmakers last week approved a bill — signed by Gov. Gary Herbert on Wednesday — meant to give health care workers more flexibility during the coronavirus pandemic and establish their legal immunity when prescribing experimental and off-label medication.