A coronavirus drug has already been deployed in the U.S. as the WHO declares a pandemic
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Happy Wednesday, readers.
As we learn more and more about the number of coronavirus cases in the U.S.—and, keep in mind, those figures will swell rapidly given the dearth of testing in America to date—one company appears to be ahead of the pack in the COVID-19 treatment space.
That company is Gilead, and its antiviral treatment remdesivir is already being used on a “compassionate use” basis in Washington state, which has suffered nearly two dozen coronavirus-related deaths—by far the most COVID-19 fatalities in the United States.
On Wednesday, the World Health Organization (WHO) officially labeled the outbreak a “pandemic”—a term it had been reluctant to use until this point for a variety of reasons.
Remdesivir, you may remember, has been hop-skip-jumping its way through the regulatory process. There were already clinical trials of the antiviral underway on a patient who had been quarantined on a cruise ship; Gilead has launched late-stage studies in multiple hard-hit nations.
But now, the Food and Drug Administration’s (FDA) compassionate use program is helping speed the treatment to patients outside of a clinical setting, as Centers for Disease Control (CDC) director Robert Redfield said during congressional testimony on Tuesday.
We’ll find out just how effective the drug is soon enough. And the hope is that Gilead can buy the world some crucial time as we deal with this outbreak.
Read on for the day’s news.
Defining digital health. You may have noticed we talk a lot about digital health in this newsletter. (Heck, the very blurb you are reading is listed under our "digital health" section!) But the term can be a little nebulous. Is digital health only relevant to health data analytics? Wearable technology? New frontiers in the genomic revolution such as gene-editing? All of the above? HIMSS, the nation's largest health IT professional organization (which had to cancel its eponymous conference over coronavirus concerns), has some guidance: "Digital health connects and empowers people and populations to manage health and wellness, augmented by accessible and supportive provider teams working within flexible, integrated, interoperable, and digitally-enabled care environments that strategically leverage digital tools, technologies and services to transform care delivery." (MobiHealthNews)
IBM supercomputer to be used to identify COVID-19 drug candidates. The Department of Energy has teamed up with IBM to fuel coronavirus drug development. The Oak Ridge National Laboratory has used IBM's Summit supercomputer to identify nearly 80 small molecules that may be able to ward off (or at least combat) the coronavirus, with simulations of more than 8,000 potential compounds. (Oak Ridge National Laboratory)
Another twist in the coronavirus supply chain disruption saga. The supply chain disruptions wrought by the coronavirus are well known at this point. Airlines are facing a debacle, drug makers are shaking up their manufacturing approaches, and good luck holding a conference of any kind. Now there's a new hitch—the Food and Drug Administration (FDA) has postponed nearly all overseas inspections of international drug manufacturing plants whose medicines make their way to the American market. (Plants which manufacture the most important drugs will still receive inspections.) Given that Asian nations produce the bulk of the world's generic drugs (which constitute some 90% of prescriptions in America), the decision is striking. (BioPharma Dive)
THE BIG PICTURE
Local authorities will play an increasingly larger role in coronavirus response. Health and Human Services (HHS) Secretary Alex Azar said on Wednesday that local health authorities must step up in the coronavirus fight—a tacit admission that the federal government won't be able to provide all available resources and services. “You’re going to hear from CDC today and the White House that we’re going to be making recommendations to those local communities about aggressive steps that we think they should be taking,” said Azar. The federal government has come under fire for what critics say is a lackadaisical response to the outbreak, including bottlenecks in testing and rigid criteria for those who should be examined. (Reuters)
Combating coronavirus begins with keeping health workers well, by Arianna Huffington & Michelle Williams
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