The little unproven drug that could

It’s been another action packed week for chloroquine and hydroxychloroquine, the unproven treatments for Covid-19 being personally championed by President Trump.

Sandoz and Bayer kicked off this week’s chloroquine mania by donating 30 million doses of hydroxychloroquine and one million doses of chloroquine to the federal government this weekend. Shortly after, the FDA issued a so-called Emergency Use Authorization for both drugs, which will allow the agency to dispense these drugs to hospitals. The granting of the EUA, which according to FDA policy is reserved for products where the “known and potential benefits of the product … outweigh the known and potential risks,” shocked FDA policy watchers.

“I would like to see who @FDA_MCMi signed off on this EUA despite the total lack of scientific evidence that chloroquine/hydroxychloroquine are beneficial in the treatment of COVID-19,” tweeted Dr. Luciana Borio, President Trump’s former National Security Council director for medical and biodefense preparedness.

The move was applauded by Trump’s allies, who are claiming an EUA from the FDA proves Trump was right about his enthusiasm for the drugs. That’s already worrying ethicists.

“There’s just going to be a lot more confusion. People are going take this to mean, ‘Oh, FDA said it’s safe and effective,’” said Holly Fernandez Lynch, a professor of medical ethics at the University of Pennsylvania, who added that is “not at all” what the FDA is saying.

The moves by the federal government comes amid growing state action to restrict doctors who might prescribe these unproven drugs. At least eight states have already restricted those prescriptions, according to the National Community Pharmacists Association. Another 14 have urged pharmacists to use caution when filling these prescriptions. But the restrictions are already rubbing pharmacists the wrong way, according to a new survey from NCPA, which found that 83.8 percent of independent pharmacists believed they should be able to dispense a limited supply of the drugs as long the patient has tested positive and is under a doctor’s care. They surveyed 460 pharmacists.

The president asks, the FDA answers

The FDA loosened some restrictions on a new mask sterilization process from the Ohio company Battelle this weekend, just hours after Trump and Ohio Gov. Mike DeWine, a Trump ally, girded the agency for restricting how many masks Battelle could sterilize per day.

The tweets tell the story:

Trump, on March 29 at 12:12 p.m., tweeted: Hope the FDA can approve Mask Sterilization equipment ASAP. As per Governor @MikeDeWine, there is a company in Ohio, @Battelle, which has equipment that can sterilize masks quickly.

FDA Commissioner Steve Hahn, on March 29 at 2:03 p.m., tweeted: Dear @POTUS, our team at @US_FDA is actively working with @Battelle to help them scale up their N95 decontamination efforts. Everyone is working together quickly! @GovMikeDeWine

Hahn, on March 29 at 11:50 p.m., tweeted: We issued a new authorization this evening to @Battelle for their decontamination system. @US_FDA staff have been working nonstop across gov and with the private sector to deliver solutions to the American public.

Trump, on March 30 at 7:07 a.m., tweeted: Thank you Dr. Hahn & the FDA for your fast approval of this respected Ohio company recommended by Governor @MikeDeWine. Great potential!

More calls for industry relief

Last week it was hospitals and ER doctors calling for special accommodations, this week its private Medicare plans. In a new letter shared first with STAT, the Better Medicare Alliance is warning that Covid-19 is likely to impact Medicare Advantage plans’ consumer ratings and their risk adjustment calculations, both of which have a big impact on how much plans get paid. Now they’re calling for HHS to make some serious tweaks to a forthcoming regulation that will lay out CMS’ policies toward the plans for the upcoming year, which is due out next week. Check out the letter here.

What exactly is an essential business?

Are marijauana dispensaries, vape shops, and supplement stores so essential that they should be kept open during the Covid-19 pandemic? The lobbying groups for those industries sure think so. Each industry has been organizing grassroots campaigns to push governors around the country to keep their stores open, even as other businesses are forced to close. (So too, by the way, have golfers, who are peeved to see their favorite courses shuttered…)

So far, the industries have had mixed success.

Marijuana dispensaries are already being classified as essential businesses by various states, like Pennsylvania and California. Other states, like Massachusetts, are allowing medical marijauana shops to stay open while ordering recreational dispensaries to close.

Vape shops are insisting that shuttering their industry will force vapers to go back to combustible tobacco, and that the convenience stores and pharmacies that can stay open won’t fill that gap. So far, lawmakers don’t seem convinced: STAT could only find one locality, Ontario, Canada, that had carved out vape shops as “essential.”

The Natural Products Association, which represents natural food and supplement stores, are running their own campaign urging governors to make sure these businesses can stay open, as well. Already, there are reports that one major supplement retailer, GNC, has kept its doors open, insisting that it is an essential business because in addition to its shelves and shelves of supplements it also sells “food and beverage products.”

More coronavirus coverage you may have missed

STAT’s got a new Covid-19 tracker looking at case rates by country and by state, and how they’re changing over time.

STAT’s Helen Branswell spoke with three clinicians from hospitals across the U.S. about what it looks like to be on the front lines of the Covid-19 response — and what we might expect to happen in facilities across the country in the weeks to come.

There’s a volunteer network in Minnesota that matches medical students with health care workers in need of child care, pet-sitting, or just help with errands like grocery runs.

Can artificial intelligence help detect Covid-19? Depends on who you ask.

How do ventilators work and why are they so important to the coronavirus pandemic?

Exploring two new models for when the U.S. will go off of lockdown.

RIP drug pricing reform?

The $2 trillion coronavirus stimulus has further dampened the chance for the Senate to take up the bipartisan drug pricing reform proposal that’s been held up for months by Senate Majority Leader Mitch McConnell. The sweeping stimulus package says virtually nothing about drug prices, but it extends funding for certain health care programs from May to November. Advocates had hoped to attach drug pricing reform to that “must-pass” bill, and now won’t have another serious opportunity until after the November election, when any pressure to pass serious reforms will likely have subsided.

Another clear sign that the chance for reform is fading: Health Care Voter, a coalition of liberal groups co-chaired by Medicare For All Activist Ady Barkan and actress Alyssa Milano, had planned to hold a 21-state bus tour to “pressure the Senate and President Trump to lower prescription drug prices.” But the group announced Monday it would instead hold a “virtual” bus tour slamming Trump for his handling of the coronavirus.

More from my colleague Lev Facher here.

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Listen: In this episode of the Readout Loud podcast, STAT's Helen Branswell joins us to discuss the latest news on the coronavirus pandemic and the sudden celebrity of Anthony Fauci.