Utah health officials plan to buy 200K doses of unproven treatment for COVID-19

(AP business wire file photo) Gopesh Patel, RPh, with VLS Pharmacy in Brooklyn, has filled physician prescriptions for more than 70 COVID-19 patients, supplying a compounded formulation with hydroxychloroquine.

State officials are planning to buy a stockpile of malaria drugs to treat as many as 200,000 coronavirus patients in Utah, even though medical experts have discouraged them from purchasing the unproven medication.

The deal with the Utah pharmacist who has amassed the drugs isn’t finalized, said Tom Hudachko, a Utah Department of Health spokesman. But the idea is to distribute the huge supply of medication to pharmacies across the state, where it will be available for free to coronavirus patients, Hudachko told The Salt Lake Tribune in an email.

Patients will need to show a prescription from a physician certifying that they have an active case of COVID-19, he added.

Because the contract isn’t signed, Hudachko didn’t know how much money Meds in Motion, the drugstore chain that is working with the state, will get for its supply of medicine. He said officials will use a combination of state and federal funds to pay the business.

[Read more: A VA coronavirus study finds hydroxychloroquine results in more patient deaths]

“We are in a public health crisis in a life and death situation. Why wouldn’t we give those fighting this virus a possible voluntary treatment option with minimal downsides to combat COVID-19 that is approved by the FDA?” Senate President Stuart Adams, a believer in the drugs’ promise, said in a prepared statement. “If this treatment works, Utah will be ahead of the curve and have a supply for citizens without usurping current users’ supplies.”

However, at least two medical experts consulted by state officials have advised against buying the medication, given the lack of scientific data that it combats the virus.

In response to the state’s request for input on the potential purchase, Dr. Andy Pavia, pediatric infectious diseases chief at University of Utah Health, stressed that there is no solid evidence that the drugs — hydroxychloroquine and chloroquine — help coronavirus patients. Moreover, clinical trials in Utah are already offering access to the medications “in a setting where patients will be carefully monitored," he said.

“There is no rationale for the state to expend precious resources to purchase additional supplies of these drugs,” he continued in a late March email to state health workers. “If they do prove effective, there are pathways to obtaining supplies if we exhaust our current supplies.”

In the same email thread, Dr. Mark Shah of Utah Emergency Physicians also discouraged the state from buying the Meds in Motion drugs.

“There is no current evidence to support its use,” Shah wrote to Melissa Dimond, director of the state’s epidemiology bureau. “We are waiting for clinical trials to give us guidance.”

Reached by phone Monday, Pavia said there is still no data supporting the use of malaria drugs in coronavirus cases. If anything, he said, there’s been more evidence recently to suggest potential harm.

He called the state’s anticipated purchase of the drugs an “incomprehensible decision.”

Still, Dan Richards, the owner of Meds in Motion, has spent weeks engaging powerful state officials in talks about dispensing his medication outside of these trials. The malaria drugs he’s offering for sale have been touted by President Donald Trump and FOX News personalities as a promising treatment for the coronavirus, and Richards has said that disseminating the medication could help alleviate the fear that is paralyzing the state’s economy.

“If we shut down the economy for the next six months there could be as many people who die by suicide as die by the virus,” Richards said earlier this month in an interview with The Tribune. “So we have to marry economics and medicine.”

Richards is part of an informal group of businesspeople and state leaders — including Adams — who have been brainstorming about medication and testing as the state battles the pandemic. Members of this group drew attention to the malaria medicine during a March news conference at the Utah Capitol, where an occupational health physician invoked the biblical resurrection story of Lazarus in describing the drugs’ alleged ability to pull coronavirus patients back from the brink of death.

(Rick Egan | Tribune file photo) Family physician Dr. Marc C. Babitz, center, says a few words as elected officials, from left, Utah Senate President Stuart Adams, Sen. Kirk Cullimore, Dr. Kurt Hegmann, director of Rocky Mountain Center for Occupational and Environmental Health at the University of Utah, Dan Richards, CEO, pharmacist of Meds In Motion Pharmacy, and Sen. Karen Mayne, keep their distance from each other as they talk about how they are teaming up to fight the coronavirus, in a news conference at the Utah State Capitol, Friday, March 20, 2020.

Realizing the malaria drugs were in short supply in some parts of the country, Richards said he bought massive quantities of powder to produce the medication and has been working in recent weeks to put them in capsules. The drugs the state is buying from Meds in Motion are enough for 200,000 weeklong courses of treatment, Hudachko said.

However, Utah drug stores so far haven’t had problems keeping these medications in stock, Senate Majority Leader Evan Vickers, a Cedar City pharmacist, has said.

Without a clear need for the drugs, Alliance for a Better Utah, a government accountability and progressive advocacy group, said it appears Utah leaders are simply “bankrolling one individual’s speculative business decision.”

“Dan Richards made a business investment by purchasing raw chemical powder that can be compounded into chloroquine and hydroxychloroquine, then lobbied President Adams to push the medication," Lauren Simpson, the alliance’s policy director, said in a prepared statement. "Adams and Richards have both publicly advocated for the off-label use, in spite of the risk and warnings from medical professionals. This is a closed-door sweetheart deal.”

Adams, R-Layton, said it was “disheartening to see people make this about politics and taking cheap shots instead of looking for solutions.”

He noted that the drugs have been used for decades to treat people with lupus, malaria and rheumatoid arthritis and said the public-private partnership with Meds in Motion shows Utah is leading the way and “doing everything possible to help citizens beat this virus.”

Though the drugs have been prescribed for years for lupus and rheumatoid arthritis and are well understood, health experts say they can still come with dangerous side effects. In rare cases, they can cause life-threatening heart arrhythmia, Utah physicians have said, and it’s not yet clear if prescribing them for COVID-19 is a risk is worth taking.

Researchers with the University of Utah Health and Intermountain Healthcare have launched two clinical trials to study hydroxychloroquine for hospitalized coronavirus patients and people who are recovering at home. The investigators leading these studies say they plan to enroll about 2,300 patients — making the drugs an option for many of the roughly 3,000 Utahns who have been diagnosed with the disease so far.

Because of the potential side effects, physicians leading the clinical trials are checking in daily with outpatient participants and will look for potential drug interactions or heart problems that would put them at higher risk. Hospitalized patients are undergoing electrocardiogram screenings to look for any heart issues, the researchers said.

The Food and Drug Administration (FDA) recently issued an emergency authorization to use hydroxychloroquine from the national stockpile for hospitalized COVID-19 patients — but only those who can’t access the medicine through a clinical trial.

Rep. Suzanne Harrison, a physician anesthesiologist, said she agrees with other health experts that these scientific studies are the safest avenue for Utahns to try these off-label remedies.

“We have at least four high-quality clinical trials going on in Utah — this is the appropriate setting for hydroxychloroquine use," the Draper Democrat wrote in a text message. “A group of infectious disease physician leaders with expertise in this field have formally recommended that the state NOT make this purchase. We need decision-makers to listen to the medical experts.”

Last week, Utah lawmakers passed a bill to grant legal immunity to physicians who prescribe off-label or experimental medications to coronavirus patients and to the pharmacists who fill their orders. Hydroxychloroquine and chloroquine fall into this off-label category, since they haven’t been approved as a remedy for the coronavirus.

The bill won bipartisan support, with Senate Minority Leader Karen Mayne advocating for freeing up “all tools available” to battle the virus.

“We need to give those people that are dealing with this horrible disease the structure that they need and the pathway that they need," Mayne, D-West Valley City, said in explaining her support for SB3002. She also had attended the earlier news conference promoting use of the drugs for COVID-19 patients.

But in a written analysis, Dr. Brandon Webb of Intermountain Healthcare said he didn’t think the legislation would do anything to make medications more accessible in Utah and expressed a broader concern that state leaders aren’t soliciting enough input from medical experts during the pandemic.

“I would continue to urge lawmakers to seek consultation from local expertise within the fields of infectious disease treatment and outbreak epidemiology when considering policy decisions about this outbreak,” Webb, an infectious disease specialist who is helping to lead one of the clinical trials, wrote in an email to a state representative. “I remain very concerned that other voices of well-meaning but unqualified groups seem to be driving policy.”