Facing shortages, Michigan asks feds for experimental coronavirus drugs
Mary Louise Luczkowski phoned her local pharmacy this month to refill a prescription she needs to keep her autoimmune disease at bay.
Then the Detroit resident got a jolt — her pharmacy was out of hydroxychloroquine, a medication she’s taken for lupus since 2010 that is suddenly in high demand as an experimental treatment for a deadly coronavirus that has swept the state and the country.
Medical experts say there is no conclusive evidence the drug, also widely used to treat and prevent malaria, improves outcomes for COVID-19 patients despite anecdotal success stories and claims of “tremendous promise” by President Donald Trump.
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There is hope and demand, however, and the Michigan Department of Licensing and Regulatory Affairs said last week there are “multiple allegations” of physicians inappropriately prescribing hydroxychloroquine or chloroquine to themselves, family, friends or coworkers.
Luczkowski figured she had enough left to last for maybe a month, if she cut her prescribed dose in half.
“I’m keeping my fingers crossed,” she told Bridge, adding that running out of medicine “would mean I would probably become sick.”
With heightened demand prompting worldwide shortages, Gov. Gretchen Whitmer’s administration last week warned Michigan medical providers against stockpiling hydroxychloroquine or chloroquine, antimalarial drugs that are effective to treat lupus, rheumatoid arthritis and other ailments.
But those supply concerns appear to be fading after drug maker Sandoz donated 30 million doses of hydroxychloroquine sulfate to the federal government’s Strategic National Stockpile and Bayer Pharmaceutical donated another 1 million doses of chloroquine phosphate.
The U.S. Food and Drug Administration on Sunday granted emergency authorization for the federal government to distribute the donated drugs to states, where doctors can prescribe them in limited circumstances: for hospitalized teens and adult patients with COVID-19.
The Whitmer administration is “pursuing a request” for the drugs from the Strategic National Stockpile, Michigan Department of Health and Human Services spokeswoman Lynn Sutfin told Bridge Magazine late Monday. It’s not immediately clear how many doses the administration seeks.
The state’s earlier advisory urging pharmacists to take “special care” to examine the “legitimacy” of chloroquine and hydroxychloroquine prescriptions was supported by the Michigan State Medical Society and the Michigan Pharmacists Association.
The groups warned of shortages for patients with conditions like lupus and suggested “any prescription medicine that may be effective in treating COVID-19 must be reserved for Michigan’s sickest and most vulnerable patients.”
But the government advisory sparked blowback from the political right. In tweets later deleted for violating Twitter rules, conservative activist Charlie Kirk and Rudy Guiliani, Trump’s personal attorney, accused Whitmer of “threatening doctors” and risking lives to oppose the president.
State officials have pushed back against similar claims, arguing Michigan is simply urging doctors to adhere to traditional standards of practice and exercise appropriate professional judgement.
“Prescribers and dispensers have a responsibility to apply the best standards of care and use their clinical judgment when prescribing and dispensing these and any other drugs to treat patients with legitimate medical conditions,” said David Harns, a spokesman for the Department of Licensing and Regulatory Affairs.
“Hoarding and stockpiling drugs for one’s own personal use is inappropriate.”
Whitmer said Monday the state wants to be “nimble” in the crisis and is continually updating and adjusting policies to meet the moment.
“We want to ensure that doctors have the ability to prescribe these medicines,” the governor said in a press briefing. “We also want to make sure that the people who have prescriptions that predated COVID-19 have access to the medication they need. And so all of the work that we’ve done is trying to strike that balance.”
Several Michigan hospitals are using chloroquine and hydroxychloroquine on COVID-19 patients, but even some experts who have used the drugs caution that there is not enough scientific evidence to prove their efficacy.
“We don’t know if these agents will work, and if they do, we don’t know the ideal patients that will benefit from them,” said Jason Pogue, a clinical professor at the University of Michigan College of Pharmacy and an infectious disease clinical pharmacist at Michigan Medicine.
That’s because scientists have not yet completed rigorous clinical trials to determine if COVID-19 patients who use chloroquine and hydroxychloroquine have better outcomes than those who do not.
There’s a laundry list of reasons that that study (of using hydroxychloroquine and Z-Pak for COVID-19) is flawed.” - Jason Pogue, a clinical professor at U-M
Test-tube studies suggest hydroxychloroquine may have an “inhibitor” effect against the virus, and China announced in mid-February that chloroquine could help mitigate symptoms and shorten hospital stays. But six weeks later, Chinese researchers have not released data to support their claims, Pogue said.
There is no vaccine for the virus, although separate research is underway. Patients with mild symptoms are typically quarantined, while those with more serious respiratory issues receive supplemental oxygen treatments or are placed on mechanical ventilators to help them breathe.
At Michigan Medicine, medical providers have given chloroquine or hydroxychloroquine to a handful of patients with COVID-19.
That’s a “reasonable” approach given available evidence, Pogue said, but “I honestly don’t know” how effective it will be and “that recommendation could change any day.”
Hydroxychloroquine may not be a “miracle cure,” but there is enough evidence to “justify its use” at this point, said Dr. Marcus Zervos, head of the infectious diseases division at Henry Ford Health System.
The Detroit-based hospital system is using hydroxychloroquine in combination with other therapies in an attempt to reduce the likelihood of complications, Zervos said Tuesday in a video chat with reporters. About 800 patients — half in Detroit — have been treated with the drug since March 1 at various Henry Ford hospitals, according to a spokeswoman.
“We have had a number of success stories — patients that have been severely ill, we’ve gotten them off the ventilator and out of the hospital,” Zervos said. But hydroxychloroquine appears to have greater benefits “if we’re able to start the therapy earlier,” he added.
More recently, French researchers published a study suggesting COVID-19 patients could benefit from a combination of both hydroxychloroquine and azithromycin, an antibiotic marketed as Z-Pak.
But the initial French research was based on only six patients who were tested after six days, and one of them tested positive for the virus on day eight, Pogue said. “There’s a laundry list of reasons that that study is flawed.”
Dr. Mohammed Arsiwala, president of the Michigan State Medical Society, said he has personally used a combination of hydroxychloroquine and azithromycin on one COVID-19 patient, but without clinical testing he does not have confidence in the approach.
“The patient did recover, but I don’t know if that worked or the patient recovered on their own,” he said. “It’s hard to say.”
Ariswala runs Michigan Urgent Care, a chain of facilities in southeast Michigan that as of Monday had reported 24 confirmed cases of COVID-19.
He said he tried to prescribe hydroxychloroquine and azithromycin to a second patient but was denied the hydroxychloroquine request by a pharmacist because of shortages.
Michigan Medicine is now recommending against the routine use of azithromycin.
“One of the big concerns that I have is that both of those agents share a similar toxicity, which can be additive, so it can cause some cardiac issues in patients,” Pogue said. “So you’re giving this combination therapy with really no data to support it, but definitely a risk for adverse outcomes.”
Michigan Urgent Care is only willing to try the drug on younger and otherwise healthier patients because of the associated toxicity, Ariswala said.
“According to what we know right now, based on all the scientific evidence, there is actually no treatment that really directly works against COVID-19,” he said.
Henry Ford hospitals using hydroxychloroquine to treat COVID-19 patients are typically using it in combination with azithromycin, according to Zervos. He said the health system is also using hydroxychloroquine with another antibiotic called doxycycline, which appears to have fewer side effects.
“One of the reasons that the virus can be so deadly is it activates the immune system— there’s an overreaction of the immune system — and the azithromycin may also help to reduce some of that over activity of the immune system,” he said.
“The small risk of having an issue with some sort of a cardiac problem can be mitigated by us monitoring the patient in the hospital.”
Pogue said he understands the hope for an effective treatment but cautioned residents against believing everything they read on the internet or trying to practice “Twitter- or Facebook-based medicine.”
“We’re also clamoring for positive outcomes right now,” he said. “Every one of us who takes care of patients wants a therapeutic option to work. That’s our goal. That’s our hope. That’s what we want to occur. But we can’t manufacture science to get to that endpoint.”
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