My paper today with Mark McClellan. We can sharply reduce the #COVID19 threat with technology and have the chance to develop and deploy these tools right away. We need to take some new policy steps to achieve these goals. We outline those steps here 1/n https://healthpolicy.duke.edu/sites/default/files/atoms/files/covid-19_tx_working_paper.pdf …
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1. We need to launch two task forces dedicated to development of therapeutics and vaccines inside FDA. We can implement a master protocol that allows broad access to promising therapies for patients in need while continuing to collect rigorous data on safety and effectiveness.
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We need dedicated focus on developing drugs, antibody prophylaxis and vaccines. A large treatment protocol, where patients are randomized to receive therapies that meet initial threshold for safety, effectiveness, can allow broad access while continuing to evaluate drugs.
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2. We need to develop a point of care diagnostic like the Cepheid GenXpert or a swab that produces a readable result in doctors office to screen much more broadly and detect cases early, contain spread. Case-based strategies can work when properly resourced, done at massive scale
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3. We'll have broad screening capability after initial epidemic passes. We must repurpose these tools into a massive sentinel surveillance system nationwide, that will hunt for cases of coronavirus among those presenting with flu symptoms, so we can detect outbreaks immediately.
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For therapeutics, we should invest in securing manufacturing now for promising drugs, so if one works, we can produce it at massive scale immediately. We should not do these thinks in a linear way. We must do it all at once. Ramp up manufacturing now for the experimental drugs.
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We must continue the mitigation steps to reduce death and disease until we have broader access to a truly effective drug. The number of cases will start to rise a lot now. We must keep the cases low enough so our front line providers can do what they do so well: preserve life.
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Tell people to cover their faces, Dr. Gottlieb.
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