A single line often inverts meaning once you see what it
answers, so neighbouring messages are always shown.
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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.
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2014-11-15 00:00
Anthony S. Fauci
Nov. 15, 2014 - Sierra Leone surgeon, resident of Maryland, green card resident, married to US Citizen hospitalized at University of Nebraska having gotten infected in Sierra Leone. He is critically ill and may not survive. He entered Nebraska Hospital with Creatinine of 16, pH of 7.1 and K+ of 2.0. NIH is thus up next for a patient.
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Nov. 17, 2014 - dies at Nebraska Medical Center.
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Nov. 19, 2014 - Today I testified before a Congressional Hearing of the House Committee on Commerce and Energy, Health Subcommittee chaired by Congressman Pitts from Pennsylvania with Dr. Burgess of Texas as the vice chair, and Mr. Henry Waxman of California as the ranking member. It was a lively hearing that went very well but with some interesting sharp interchanges between me and Dr. Cassidy from Louisiana. He is a physician who tried to show off about his medical knowledge in the hearing; however, during the exchange it became clear that he really did not know what he was talking about. In addition, Congressman Tim Murphy somewhat attacked me saying that I have been condescending to people who question the issue of conmtrolled trials with placebo limb, transmission, patient isolation and quarantine. I did not have the opportunity to refute him; however, after he had left when Mr. Burgess who took over the chair of the committee when Mr. Pitts left gave us the opportunity of a summary statement, I question Mr. Murphy's characterization of me as being condescending and clearly stated that our most important goal with interventions is to first do no harm and then hopefully benefit people and although many individuals feel that this is insensitive, on Ebola. Panel in fact it is not insensitive, but is the time-honored way of determining the safety and efficacy of interventions. In addition, after she had left I countered the somewhat snide remark of Mrs. Blackburn who had also made a statement without giving me the opportunity to respond. She said that we were negligent in not getting countermeasures done quickly and that industry can do better than we can. I stated after she left that we have been trying to get partnerships with industry for over 10 years in the development of Ebola vaccines and that only recently were pharmaceutical companies willing to partner with us. All in all it was a very positive Hearing.
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Nov. 20, 2014 - Did Newsmaker Luncheon talk at the National Press Club on Ebola. Got much play in the printed press. Things still calm regarding Ebola with attention switching from the threat in the USA to background issues like the $6.18 billion request from the POTUS (see above Senate Hearing). Also, some increasing noise from Congressman Tim Murphy (R-PA) regarding his pushing for the leaders of the 3 Ebola hospitals (NIH, Emory, Nebraska) to quarantine for 21 days their staff that took care of Ebola patients and not allow them to see other patient for 21 days. We are all adamantly against this and I have been the vocal one saying that we must stick with the science and the CDC recommendation of stratification of risks to HCWs balanced by the stratification of monitoring and restrictions. Murphy is not happy with me. Had dinner with Danny Hultzen and his father Chris. Discussed the situation with his shoulder injury. He feels good and looks great. I have a strong feeling that if his shoulder holds out, he will make it to the MLB with the Seattle Mariners.
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Nov. 25, 2014 - Did Webcast for Harvard School of Public Health on Ebola. Panel discussion with Barry Bloom and others. NEJM paper to come out of Thursday (Thanksgiving) reporting on the results of the phase 1 trial of the NIAID/GSK Ebola vaccine (Ledgerwood et al). Embargoed until Wednesday (Nov 26) at 5:00 PM. And so press starting to get excited about it. Thus, did CBS Evening News tape for Friday PM? Also, Medscape Interview. And plenty of embargoed print interviews. As expected, the Brits (Wellcome Trust, Adrian Hill from Oxford) are downplaying the study saying the required dose is too high and the durability is low without a booster. They are amazing.