By Mary Beth Pfeiffer

Unproven. That’s the word that has come to describe hydroxychloroquine, the drug that has shown promise in treating COVID-19 in two French studies.

In the best scientific sense, that characterization is true. The FDA knows this. But it saw fit Sunday to allow doctors to use the medication “off label” for coronavirus, meaning outside of its approved use, as is allowable for other medications.

Hydroxychloroquine is decades old, safety tested and used by thousands for malaria, lupus and rheumatoid arthritis. At the same time, coronavirus cases are cramming hospitals for an average of 11 days by one study. Some are dying when the disease advances too far. The medical toolbox is sparse. It’s time.

Margaret Novins, 53, of Manalapan, may be the future of the disease. She is a story of success in a crisis-driven, real-time trial to beat a serious health threat.

Novins, a COVID-19 patient I wrote about on March 22, was discharged last Wednesday from CentraState Medical Center in Freehold, after being treated with hydroxychloroquine and the antibiotic azithromycin, as in the French studies. She thinks the drugs “turned the corner” for her, after 11 days of spiking fevers.

“I’m doing great now!” she wrote in a text sent to me Sunday, along with a selfie taken in the sunshine outside her home the day after discharge. For now, she has chosen to isolate herself from her husband and daughter for two weeks although health officials said it was unnecessary. “I would rather be safe than sorry,” she wrote.

Novins, a nurse for a medical equipment company, is a model for all of us, having also carefully segregated herself from her family the day she believed she was sick March 8.

Her case is instructive in other ways, too.

Though admitted March 16 with breathing problems, she wasn’t treated with the drug regimen until March 19 when proven positive. If treated earlier, might she have gone home sooner at a time when beds are winnowing and hospitals diverting patients elsewhere?

Novins also was treated before she needed a respirator, potentially saving a precious hospital resource.

In New York, where some city hospitals are overwhelmed, hydroxychloroquine has been limited to a trial of 1,100 patients. The FDA’s statement clears it for use for “hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible.”

In general, the agency’s emergency approval may be issued when “the known and potential benefits of the product … outweigh the known and potential risks ... and there are no adequate, approved, available alternatives.” Among those benefits, of the 80 patients in the second French study, 83% were COVID-negative at Day 7 of treatment, and 93% at Day 8.

“Doctors should be able to prescribe,” Novins told me via text Sunday. “Personally, I prefer ‘old’ drugs to ‘new’ drugs. I’d rather this protocol than something new and untested.”

Novins’ records, which she provided, show she was also on other anti-viral drugs while hospitalized, factors that subsequent trials will need to consider in finding what works for COVID-19. For her, hydroxychloroquine and azithromycin seemed to spur immediate improvement.

“I was fever free by the next day and recovered from there ;),” she wrote in her text.

Margaret Novins in one patient, one anecdote, that albeit is supported in emerging medical studies. We will know soon if the drug combination is curative for many more COVID patients.

For now, her shared story is one ray of badly needed hope.

Mary Beth Pfeiffer is an investigative journalist and author of “Lyme: The First Epidemic of Climate Change.”

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