Desperate times, desperate measures. Anthony Fauci has been warning lately that we need to wait for clinical trials to know if hydroxychloroquine is effective against coronavirus, but there’s simply no time. New York City is in the thick of an outbreak right now. There’s anecdotal evidence from China and France that the drug helps. What’s more, the clinical trials are progressing slowly due to a (surprising) dearth of volunteers.
There are many thousands of patients in NYC right now clamoring for relief. Doctors have no answers. Hydroxychloroquine is already on the shelf as a treatment for rheumatological disorders so it’s safe for human consumption (in appropriate doses). It’s a cinch that doctors will administer it on nothing-to-lose “compassionate use” grounds. But if they’re going to do that, why not turn it into a true drug trial and start tracking the results systematically instead of just dosing it out haphazardly? You have thousands of “test subjects.” If the drug is effective, it’s a gamechanger for the whole world. Let’s collect the data.
So that’s what they’re going to do, with unheard-of speed. Per WaPo, this isn’t a clinical trial (no one’s getting a placebo, obviously), it’s an “observational trial.” Doctors are going to give out the drug freely and carefully chart what happens. In a few weeks we’ll have meaningful numbers about doses, survival rates, effectiveness at different stages of the disease, and so on. Normally it takes nine months or so to arrange something like this; New York’s rolling it out in three days. The clinical trials, I take, it will merely end up confirming what doctors in New York City discover first.
It’s magic-bullet time.
New York will use three medications — hydroxychloroquine and chloroquine in combination with the antibiotic azithromycin — contributed by the Federal Emergency Management Agency and an unnamed drug company, said a New York state health official, who spoke on the condition of anonymity to discuss evolving plans candidly, in an interview Wednesday…
Patient outcomes from the experiment will be gathered electronically and contribute to an “observational” trial being coordinated by the government, the official said. In an observational trial, which is considered less rigorous than a controlled trial comparing a treatment with a placebo, researchers see if a therapy is safe and effective by gathering and comparing the results in a large database.
In addition to mortality and overall recovery, the study will measure patients’ overall viral load, duration on a ventilator and number of days in the hospital…
“I have never seen anything like this. It is amazing how the country and everybody can pull together and come up with quick, innovative ways to try to attack it,” said Onisis Stefas, chief pharmacy officer for Northwell Health, which has 22 hospitals in New York and has already been using the anti-malarial drugs to treat patients on a “compassionate-use” basis.
If the drug can rescue critically ill patients from the brink, that’s great. If the drug can prevent mildly ill patients from developing into critical cases, that’s fantastic. The best-case scenario is that it functions as an ersatz stopgap vaccine until we have the real thing. But the world will take anything it can get here.
There was a ton of political pressure brought to bear to make this happen. Trump’s been pressuring the FDA publicly to approve hydroxychloroquine’s use for coronavirus. That hasn’t happened and won’t until there’s more data, but this New York observational trial presumably could move them if the results are good. Trump’s interest has ignited public pressure too, and not in entirely good ways: “[C]hloroquine orders spiked 3,000% in March and hydroxychloroquine orders rose 260%,” per CBS, with some people who aren’t sick resorting to hoarding the drug even though rheumatological patients need it. Andrew Cuomo’s also taken in an interest in hydroxychloroquine, presumably out of sheer desperation to try something to ease the crisis. He issued an executive order banning prescriptions of it for the general public to treat COVID-19 but he’s also said that 70,000 doses (plus many more doses of chloroquine) are en route to hospitals. With all of that weighing on it, and with a ton of criticism aimed at it for moving too slowly to address early problems with testing, the FDA seems to be moving more quickly and creatively on the crisis now.
But even without all of that pressure, the sheer numbers might have forced it to act at this point:
New York State #coronavirus
Total Cases: 37,258
NYC Cases: 21,393 up 20% from yesterday
Statewide Deaths: 385
Currently Hospitalized: 5,327
— John Seravalli 🇺🇸🇮🇹🗽 (@John_Seravalli1) March 26, 2020
America now leads the world in confirmed coronavirus cases (with a giant asterisk attached to China’s numbers in second place). It’s not just a tragedy; compared to how effective countries like Japan, South Korea, and Germany have been in managing their outbreaks with far less carnage, it’s a national embarrassment. Federal agencies like the FDA are going to do what they can to atone for their grievous failure to prepare better. They’re probably also worried about public anger rising here as lurid reports of the desperation in American hospitals circulate more quickly. This story describes the situation in Spain, which has also been hard hit, but it’s not so different in tone and detail from a grim report on Elmhurst Hospital in Queens that the Times ran yesterday.
People are dying in waiting rooms before they can even be admitted as the coronavirus pandemic overpowers medical staff. With some funeral services halted in the Spanish capital and no space left in the morgues, corpses are being stored at the main ice rink.
Intensive-care wards overflowing and new rules dictate that older patients miss out to younger people with a better shot at surviving, Bernabeu said by telephone. “That grandpa, in any other situation, would have had a chance,” he said. “But there’s so many of them, all dying at the same time.”…
In several care homes for the elderly, staff abandoned the residents to their fate. Army units mobilized to disinfect the facilities found some patients lying in squalor and others remained where they had died in their beds, Defense Minister Margarita Robles said on Monday.
We haven’t seen anything as shameful as staffers abandoning nursing homes. But there are reports of American doctors debating whether to reluctantly refuse to attempt to revive patients in the throes of death because it’s just too risky for them to get close to the patient’s nose and mouth without protective gear. The risk of people dying while they’re waiting to be treated is real too, with the Times claiming that one patient recently had to wait 36 hours for a bed.
New York-Presbyterian Hospital is reportedly trying to extend ventilators by rigging them so that patients can share them. All of the city’s intensive care beds are expected to be filled by … tomorrow.
So, yeah. It’s time to try hydroxychloroquine and any other sh*t we have on the shelf. Which includes remdesivir, the potential antiviral wonder drug that Gilead is working on. Per WaPo, Gilead and the FDA are working on a program that will let doctors try remdesivir on patients for “compassionate use” reasons without needing separate approval for each individual patient. That sounds like it’s headed in the same direction as the massive experiment that New York’s conducting with hydroxychloroquine. Is it possible that there’ll be an observational trial for remdesivir too, or does the FDA need to approve the drug as safe for human consumption before that can happen?
Here’s the situation in New York. “Paranoia.”
— The Lead CNN (@TheLeadCNN) March 26, 2020