Wednesday, March 18, 2020

WH wanted me to not wear myself out. Have had private car and driver since Mar. 13 (Friday). I will stay at NIH today and do some press tonight from truck at home. Very positive press with Laura Ingraham on FOX last night On WHO call, Dale Fisher (Australian working in Singapore) gave warning to other countries that after you lift the lock down, be prepared for a rebound and use the lockdown period to stock up on supplies, prepare alternative hospitals (gyms, schools, etc.) preserve PPE and not use them for unnecessary things. Also, from Italy, 12% of ICU patinets were 19-50 years od and ~30% were 50-70 yo; 50% of French patienets in ICU are under 60 yo. Bloomberg report on March 18 (Tommaso Ebhardt et al) said that in Italy 99% of thois who died had “othe illness”. However, 75% of these had hypertension. These latter must have been on anti-hypertensive meds and so the issue of ACE inhibitors absolutely must be pursued. On TF call we discussed the Defense Production Act and a possible EO. Also, the VP said over the phone that he wanted me at the Pressor today and Katie (good for her) pushed back and said that I should stay at NIH. VP looked surprised. Probably will hear more about this. Also, at TF meeting they decided to fully embrace FEMA and make a big announcement about that with the POTUS today. New York City and State are facing a “Sophie’s Choice” regarding PPE. They are very low and they have to make a decision of using PPE for testing versus giving to HCWs who are taking care of patients. Obviously, it goes to HCWs, but that will interfer with testing. This was related to me by phone call with Peter Staley, Mark Harrington, and James Krellerstein. 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 accelerating the clinical trial aspect of Remdesivir. Also, we clearly need to have a discussion with Gilead about drug supply and the plan for any accelerated study. Finally, and importantly, the Chinese already have a clinical trial of Remdesivir with more than 200 people enrolled in the advanced disease arm of the study. Someone should directly contact the Chinese investigators (Bin Cao, et al) and find out if they have any preliminary data on efficacy and safety. In my mind it is imperative that we find out what they know before we launch any distribution program. Happy to discuss. Thanks, Tony Anthony S. Fauci, MD Director National Institute of Allergy and Infectious Diseases Building 31, Room 7A-03 31 Center Drive, MSC 2520 National Institutes of Health Bethesda, MD 20892-2520 Phone: (301) 496-2263 FAX: (301) 496-4409 E-mail: afauci@niaid.nih.gov PRESS: Dave Webb Radio Show; Mike Gallagher Show; FOX Tucker Carlson; CNN Cuomo Prime Time;