A single line often inverts meaning once you see what it
answers, so neighbouring messages are always shown.
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Nov. 1, 2014 - Things calming down. Reports of decreased infections in Liberia, particularly Monrovia. Not sure if this is real or if the infections are now occurring in remote areas without good reporting. Also, the issue of second waves in Guinea and Sierra Leone. CDC having to put much effort into investigating Person Under Investigation (PUIs). These are people who are from West Africa who get a fever or nausea or vomiting for any of a number of benign reasons. Since they are from West Africa, these are being investigated, sometimes using PPEs, which is an "abundance of caution", but a major investment (?waste) of effort. Cliff Lane is in Monrovia doing spade work for the hopefully upcoming RCT for the Ebola vaccine. Heard on Secretary's call this AM (8:30 AM on Saturday) that now WHO (likely MariePaule Kieny) wants WHO to be responsible for the DSMBs of all clinical trials in West Africa. This is an egregious attempt on the part of WHO to stay "relevant" in an area in which they have no expertise. It is "stunning" to me how they just want to insert themselves into things where they quite frankly are incompetent. They already have made it clear that they just want to distribute unproven interventions (vaccines and treatments) and even though we seem to be winning the argument, they keep coming back in insidious ways to try to derail the scientific clinical trials process. Amazing!!
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Nov. 2, 2014 - Quiet Sunday. Trying to catch up on piles on my desk. Election on Tuesday. Concern that the GOP will take the Senate, which means Obama is in trouble with both House and Senate in GOP control. Despite reports that the number of cases in Liberia are decreasing rapidly, new reports today indicate that the cases in Sierra Leone are sharply increasing. I have warned that Ebola comes in waves and that we should not be complacent and the WH should refrain from saying that things are "turning around".
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Nov. 3, 2014 - Ron Klain visited NIH today (He had visited CDC last week). He wanted to familiarize himself with what the various components of government were doing in Ebola. I made a presentation to him in the VRC, showed him the lab where Nancy Sullivan works and where she developed the ChAd3 Ebola vaccine. Then we took him over to the Clinical Center to see Julie Ledgerwood's vaccine clinic where the phase 1 trial took place. Then we showed him the SCSU and the room where we took care of Ron was impressed and wants me to come to the WH on Friday to give a shortened version of my presentation at a meeting where the POTUS is hosting certain Congressional leaders. Tom Frieden spontaneously called me up to thank me for being so supportive of him. I have been continually serving as a late night (by phone or e-mail) sounding board for him in his attempts to negotiate his having to deal with some many factions (ASPR, HHS, USAID, etc.) Last night I helped him out by strongly suggesting that he not listen to the modelers who tell him "exactly" how many news cases of Ebola to expect in the USA over a period of time. I warned him that the models are based on assumptions and multiple variables and can be very misleading and he should not "own" data that comes 7renzy calming onference with from models or else it will come back to bite him. I urged him to totally resist such predictions. He was very grateful for my advice.
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Nov. 4, 2014 - GOP takes control of the Senate in today's elections. Frenzy calming down. Little press interest - like shutting off the faucet.
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2014-11-05 00:00
Anthony S. Fauci
Nov. 5, 2014 - Preparing for Hearings of the Senate Full Appropriations Committee (Mikulski). Tom Frieden and I will testify together with Sylvia Burwell. POTUS publicly requests $6.18 Billion in "emergency" funds for Ebola. We will dwefend this at Hearing on Nov. 12.
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Nov. 6, 2014 - Still calm. No Ebola Press. Did Hearing prep by teleconference with Sylvia.
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Nov. 7-11, 2014 - Still calm. Mostly preparing for Senate Appropriations Hearing on Nov. 12. POTUS asking for $6.18 Billion in emergency funding for Ebola (Domestic and International). NIH portion is $238 million. Went to EEOB on Nov. 10 to rehearse for Hearing with Ron Klain. Nov. 11 - very good meeting in Building 10, 4th Floor Medical Board Room with clinical investigators who took care of Ebola patients at Emory, Nebraska, NIH. Also, DoD and HHS present with presentation of individual clinical data from the USA patients. It became clear to me that it is impossible to determine if any of the experimental drugs given to the patients (ZMapp, Brincidofovir, favipiravir, convalescent sera, TKM-Ebola) helped or did harm (likely did some harm. Decision was to develop a clinical protocol for future USA patients and also to be used as prototype for Africa. Protocol should be RCt with standard medical care (fluid and electrolyte replacement) as the control arm. The data also suggested to me that if you keep patients alive with medical care, that the body's immune system will almost always clear the virus (likely without experimental drugs).
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Nov. 12, 2014 - Successful Hearing today before the Full Senate Appropriations Committee chaired by Barbara Mikulski with Richard Shelby as Ranking Minority. Sylvia Burwell, Jeh Johnson (DHS), Michael Lumpkin (DoD), Heather Higginbottom (DoS) testified and then accompanying witnesses went to the Table. Tom Frieden and I were the "accompanying" witnesses for Sylvia. All went well. About 18-20 Senators appeared. Tom Harkin made a statement that this was his last official Hearing and he wanted to specifically call me out as a great public servant with whom he has worked on this committee for 30 years. This elicited a round of applause from the audience. Patrick Leahy also remarked that he has been working with me "forever". All-in-all, a very good Hearing.
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Nov. 13, 2014 - Difficult situation arising regarding the conduct of the Phase 2/3 trials of Ebola vaccine in Liberia/Sierra Leone. The companies (first GSK; now also J & J, who do not even have a candidate ready) are balking at going ahead with the trials unless they get "global indemnification". This is unprecedented to demand for a Phase 2/3 trial since we (NIH) are the sponsors and we are liable. Nonetheless, GSK feels that although the PREP act would protect us and indirectly them, they feel that in international courts GSK (even though they are not the sponsors of the trial) could be sued given the sensitive nature of the situation (African countries, instability in the countries, brand new vaccine platform for them -Cad3 vector -, accelerated development with questions regarding lot consistency (because of the fast pace of development). This would be terrible if the trials are stalled because of this. I have phone call today with Moncef Slaoui, Chairmen of GSK for Global Vaccines. Also, despite our conclusions from meeting on Nov. 11 (see above) the Oxford/Wellcome Trust people are working with MSF to start "open label" trials with various therapeutics without a control arm. What the hell is going on here? I am very disappointed in the Brits, especially the Wellcome Trust and Oxford people who clearly are grandstanding. Call with Moncef Slaoui went well. Reasonable discussion. I stated that the USG could never give "global indemnification" since it would invite frivolous lawsuits. Moncef felt the same about our providing insurance for them since it would also invite lawsuits. We agreed upon some form of a process that provides for limited liability and cpas on settlements. I will follow-up with summary e-mail to Moncef with copy to Ron Klain with who I spoke tonight and relayed to him the conversation with Moncef. Ron is flexible, but said that we cannot "guarantee" anything to Moncef, but we will proceed in good faith to find a solution.