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The Readout Damian Garde & Meghana Keshavan

Gilead has a treatment for a coronavirus. Academics want to test it against Covid-19

There’s a compound in Gilead Sciences’ vast library that is remarkably effective against a certain coronavirus in cats. Researchers say it might hold promise for Covid-19 and could even be superior to Gilead’s own remdesivir. Now they’re pressuring the company to find out.

As STAT’s Ed Silverman reports, researchers at the MD Anderson Cancer Center have joined Public Citizen to urge Gilead, the NIH, and the FDA to run a clinical trial on GS-441524, the anti-coronavirus compound. In lab tests, GS-441524 appears to work better than remdesivir against the novel coronavirus, the researchers said, with lower toxicity and an easier manufacturing process.

So far, Gilead has showed no interest in developing GS-441524. The researchers chalk that up to “financial incentives,” pointing out that a key patent for GS-441524 expires several years before the intellectual property behind remdesivir.

Read more.

A victory for clinical trial transparency, with a catch

A decade’s worth of clinical data on approved drugs and devices could finally be made public thanks to new federal rules, but it’s unclear just how much pressure the government will put on industry to comply.

As STAT’s Lev Facher reports, thanks to a court ruling and federal action, the government has instructed clinical trial sponsors to submit data to ClinicalTrials.gov for studies conducted between 2007 and 2017 “as soon as possible.” That’s a victory for transparency advocates, who for years have fought to recover the decade-long gap in publicly available clinical trial data.

But no one knows what the government might do to compel companies to act. The FDA and NIH have the legal right to levy penalties and withhold grant funds from companies that don’t comply with transparency rules, but neither agency has ever done so.

Read more.

Warp speed is fast enough

Yesterday, amid a Twitter tempest, we asked readers whether society should wait on the results of large clinical trials before distributing Covid-19 vaccines. The answer, for the majority, was yes, please.

About 61% of respondents said Phase 3 data are key to understanding whether a vaccine actually works, and any widespread use should come only after studies are complete. The remaining 39% embraced thinking outside the box in light of Covid-19’s disastrous effects on health and society.

This may seem fairly obvious — clinical trials determine whether medicines work — but there are some prominent proponents of cutting corners when it comes to Covid-19 vaccines. Among them was Stephen Salzberg, a professor of biomedical engineering at Johns Hopkins whose editorial urging immediate vaccination blew up on Twitter over the weekend, finding at least some defenders and many more critics. It’s worth noting that Salzberg’s follow-up piece is titled “I Was Wrong: We Can’t Skip Phase 3 Vaccine Trials.”

Moncef Slaoui wakes up at 2:30 a.m.

That’s among the details the former GlaxoSmithKline executive divulges on his work leading Operation Warp Speed in a podcast interview with the Department of Health and Human Services’ head of public affairs.

The conversation delves into the workings of Warp Speed, a pan-agency effort to speed up the development of treatments and vaccines for Covid-19, before turning into media criticism. HHS's Michael Caputo, erstwhile food photographer and podcast host, says “I'm convinced that the reporters don't want a vaccine, sir,” and Slaoui explains that he was personally offended by a July 15 New York Times story pointing out that he is not required to make routine ethics disclosures or divest any of his stock in companies working on Covid-19, a potential conflict of interest. And then things took a turn.

“If I had the possibility, I would like someday to sit down with the journalist that wrote that, and look at that person in the face, and ask that person, ‘I know what I have been doing for now 10 weeks in this role, day and night. I know what I'm doing every day to try and help all the population, including you journalists. What have you been doing?’” Slaoui said.

More reads

  • A coronavirus vaccine won’t change the world right away. (Washington Post)
  • Prescription drugs may be more affordable than you think — unless you pay cash. (STAT Plus)
  • Kodak CEO got stock options day before news of loan sent stock soaring. (New York Times)
  • Johnson & Johnson spray approved to treat suicidal people. (Bloomberg)

Thanks for reading! Until tomorrow,

Tuesday, August 4, 2020

STAT

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