Amid frenzy over potential COVID-19 drug, patients see shortages and states fight reckless scripts

As the fervor around hydroxychloroquine escalates—fueled by President Donald Trump’s praising of the med as a potential COVID-19 therapy—patients who need the drug are reporting shortages and states are taking steps to lock down supply. 

Sharon Cross, a lupus patient in Arizona, has taken hydroxychloroquine for years, but she's now having trouble getting it, she wrote to FiercePharma. Her pharmacist advised her to call other locations around the state and even into Nevada to try to find her needed medication, she added.

“Many of us with compromised immune systems, the very ones who are likely to be the first victims to fall to COVID-19, already take [hydroxychloroquine] for our diseases,” she wrote.  

“Basically, this is a death sentence for those of us who are already suffering with a compromised immune system, over 60 years old, who have been denied the one medication we depend on to treat our incurable disease,” she wrote. 

Her report corroborates others for patients who have been taking the drug to treat arthritis or lupus for years. Now, they're running into shortages. 

In response, several states are moving to lock down supply by putting tighter regulations on new prescriptions, CNN reports. Six states have issued guidelines that generally allow existing patients to continue receiving the drugs as needed. New prescriptions must get special approvals. 

The states implemented the tighter controls after reports that doctors were prescribing the drug haphazardly to family and friends to prepare for potential COVID-19 infections. 

And in another tragic story from Arizona, a man has died and his wife is in critical condition after they inhaled chloroquine phosphate, which is used to clean aquariums, The Hill reports. It wasn’t clear whether they had confirmed COVID-19 infections. 

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Meanwhile, scientists and investigators are frantically working to learn if the drug can help patients with COVID-19. President Donald Trump has praised the med as a potential “game-changer,” but his medical advisors have been more reserved. Last week, NIAID chief Anthony Fauci said there's no meaningful evidence to date on hydroxychloroquine and COVID-19. Any evidence so far is "anecdotal," he added. 

At a Monday press conference, Trump said officials in New York are starting a hydroxychloroquine study in the state today. 

Enthusiasm around the drug stems partly from early learnings from a French study conducted by professor Didier Raoult and his team. In that study, 70% of patients who were given hydroxychloroquine tested negative for the virus after six days. In the control arm, only two out of 16 patients were negative after six days. Some of the hydroxychloroquine patients also received the antibiotic azithromycin; all six of them tested negative.

Despite the "small sample size," the evidence showed that "hydroxychloroquine treatment is significantly associated with viral load reduction/disappearance in COVID-19 patients and its effect is reinforced by azithromycin," Raoult wrote.

Weighing the findings, two experts told investigative journalist Mary Beth Pfeiffer the results are enough for them to recommend the treatment regimen of hydroxychloroquine and azithromycin for patients who are hospitalized with COVID-19 considering the graveness of the global pandemic and lack of available treatments.

Separately, one early study from China had been characterized as a “positive” result, but Evercore ISI analyst Umer Raffat saw things differently after looking into the data for himself. Hydroxychloroquine failed to beat placebo at virological clearance rate and temperature normalization at day 7, the analyst wrote in a Monday note to clients. The drug did beat placebo at radiological progression, but the data are tough to interpret because of the size of the study, Raffat added.

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Still, the nationwide enthusiasm around the drug doesn’t seem to be dying down. Last week, generics makers Sandoz, Teva, Mylan and Amneal stepped up to pledge tens of millions of tablets, some through donations.