Tony's Diary Package — page 58

rt, Also, had phone call with Major de Blasio who wants to go to "shelter in place for the entire city. He is asking my advice since Gov. Cuomo is pushing back. I advised DeBlasio to go ahead and do it. I will try to speak with Cuomo. POTUS called me up from Oval. He has Alex Azar, Steve Hahn, Bob Redfield Scott Gottlieb, and Deb Birx in the office with the usual WH crowd. They want me in on the discussion. A friend of POTUS (Tom Ellison of Ellison Foundation ?) said that he heards that someone gave Hydroxychloroquine (HC) to 51 people and 51 got better. POTUS has heard similar stories, including Remdesivir (R) about other drugs and wants to make these available. To my amazement and dismay, Azar said that he could approve HC and Remdesivir now with the powers that he has. Steve Hahn and to some extent Deb and Bob started to chime in that this would give people hope. I took a deep breath and said that this was wrong and should not be done. If you want expanded access (EA) of HC which is an approved drug, you can do it in an EA protocol and still get wide distribution and possibly learn something. I stated that with R it is different since this was not approved. In the chorus of eeveryone agreeing with the POTUS that we need to give hope to people, I insisted that we can do both, but in the context of a trial. To his credit, POTUS agreed with me as long as we get the drugs out there. They wanted to announce this today, but I convinced them to do so tomorrow when I am there. Below is an e-mail that I sent right after the conversation: From: Fauci, Anthony (NIH/NIAID) [E] Sent: Wednesday, March 18, 2020 2:27 PM To: Redfield, Robert R. (CDC/OD) <olx1@cdc.gov>; Stephen Hahn <SH1@fda.hhs.gov>; Birx, Deborah L. EOP/NSC <Deborah.L.Birx@nsc.eop.gov> Cc: clane@niaid.nih.gov; Troye, Olivia EOP/NSC <Olivia.Troye@nsc.eop.gov>; Short, Marc T. EOP/OVP <Marc.T.Short@ovp.eop.gov>; Miller, Katie R. EOP/OVP <Katie.R.Miller@ovp.eop.gov>; Hicks, Hope C. EOP/WHO <Hope@who.eop.gov>; kellyanne conway <Kellyanne.e.conway@who.eop.gov> Subject: Follow-up of today's conversation Folks: When we put together the proposal for the protocols/distribution of Hydroxychloroquine (HC) and Remdesivir, I feel that it is important that we do not make the program the same for each. We need to link Remdesivir to a much more strict protocol as opposed to HC which is an approved drug and although it has some adverse events, we have tons of experience with it. I am comfortable with the HC plan as discussed in the Oval. In contrast, we know much less about the unapproved drug Remdesivir. I have more concern about the potential toxicities of this unapproved, investigational drug in the context of COVID-19 as well as the need to prove that it works before we widely distribute it. The bulk of the data that we have with Remdesivir is in Ebola where it did not have a clear benefit. We should consider leading with HC in a flexible distribution protocol and