A single line often inverts meaning once you see what it
answers, so neighbouring messages are always shown.
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August 13, 2014 - My invited Perspective on Ebola came out online at 5:00 PM in the New England Journal of Medicine. Cliff Lane and I are trying to reconcile the need for data of safety and efficacy of the NIH vaccine and the need to get it to people who need it. We drew up a proposal for a Randomized Clinical Trial (RCT) to take place in the countries in Africa right after the Phase 1 here at the NIH. This would settle the ethics issue (randomization is "fair" and also would collect data to prove efficacy and safety. I geria following the will propose this at the next Secretary's call. The logistics of this will be difficult due to the lack of infrastructure in the 4 African countries. Did WBAI Radio in NYC and Al Jazeera TV today. Latest numbers for Ebola - 1900+ cases and 1050 deaths
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August 14, 2014 - Things quieting down a bit in the press. Still struggling with ethics issues and clinical trials issues. Canada has "hot-dogged" by announcing that they are "donating" 400-800 doses of their vaccine for use in Africa. Of course, that is exactly where we will give it when we show that it is safe. Also Jeremy Farrar, the head of Welcome Trust is grandstanding a bit saying we must not just "sponge down the patients and let them die". Give me a break. Now WHO wants to use the Phase 1 doses of vaccine to vaccinate their people who are going to Africa. They want 200 doses to do a "phase 1 trial" in their staff. 200 doses is a product distribution program, not a phase 1 trial. Did CBS News and AP TV today.
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August 15, 2014 - Went up to Philadelphia to see the White Coat Ceremony at the University of Pennsylvania Medical School where my daughter Megan is beginning her first year of medical school. Beautiful day and wonderful ceremony. We are so proud of Megan and hope that she will be happy. I know that she will do well having graduated summa cum laude from Columbia and then excelling in the Post-Bacc pre-med year at Hopkins.
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August 16-19, 2014 - Media blitz stopped, but the epidemic still rages. The West African countries are instituting quarantines and border closings, which may slow down the epidemic, but there is the beginning of a humanitarian crisis to get food, water and supplies to the quarantined areas. Tom Frieden and I are working out how we can reconcile the issue discussed above about the balance of open access of vaccine following phase 1 versus the need to know by RCT whether the vaccine actually works and whether it might actually do harm, as per the Ad5 HIV vaccine enhancement of HIV acquisition in a former clinical trial a couple of years ago. The department was clearly concerned (Andrea Palm - chief-of-staff to Burwell- pissed me off on a conference call by acting annoyed with Tom and me in our discussions on the daily conference call) about the disagreement between Tom and me; however, Tom and I are now trying hard to work it out behind the scenes.
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2014-08-20 00:00
Anthony S. Fauci
August 20, 2014 - Ebola still on an upswing. No explosion yet in Nigeria following the infection of cluster (8 to 11) health care workers who took care of (Liberian/American) who flew from Liberia to Nigeria). Tom Frieden and I still trying to work out an agreement/compromise regarding the distribution of Ebola vaccine (RCT versus expanded access) following the Pahe 1 trials that will begin in September and have data by November on Safety and immunogenicity. ral News Radio; Canadian TV; VOA TV bs; BBC Newsday d; WNEW Press low level but consistent. For me → Federal News Radio; Canadian TV; VOA TV - "Straight Talk Africa Show - 1 hour); ISIS (Islamic State in Iraq and Syria) taking over parts of Iraq Gaza still a mess with rocketing of Israel and retaliatory air strikes by Israel.
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August 21, 2014 - 2 secondary cases of Ebola (beyond cluster of health care workers) from the index in Nigeria. Getting close on agreement with Tom Frieden. Cliff Lane very helpful; in hammering out details with CDC people - Tim Uyeki and Steve Redd (Steve is a rally good guy with whom I dealt during the Flu issues). Continued press → MSNBC; WTOP radio; CNN with Lou Dobbs; BBC Newsday Radio.
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August 22, 2014 - Situation same with epidemic. Good news - have come to agreement with Tom Frieden on approach to Ebola vaccine following Phase1 trials. Agree to go for RCT with control group as first choice. There well may be obstacles on the ground to this approach including perception of keeping interventions from those who need it (even though we still do not know whether the vaccine is either safe or effective). This may necessitate a modified RCT without a control group or even skipping an RCT and going to emergency open access. The plan is to do a "rolling" approach staring with RCT → modified RCT → open access in priority order. I will present this to Secretary's call next week. Tom Leaves for West Africa over the weekend. Press still active → Fox 5 WTTG; CNN International; BBC Radio - The World; WNEW CBS Radio - NYC; PRI (BBC) - Boston - "The World" with Marco Werman
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August 23 - 27, 2014 - Still escalating Ebola situation. Now a secondary case in Nigeria with having infected a person who took care of him. That person (who recovered) then infected a doctor in Port Harcourt. The doctor died, but the doctor's wife is now infected. The numbers are going up. Tom Frieden now in Liberia to assess the situation. He is saying that it is catastrophic and out of control in a press conference from Monrovia. People on the Secretary's 3x per week call have criticized him for being "hyperbolic". How should they know - he is there and they are here. Typical government cover-your-ass bullshit. Still getting modest press.
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August 28, 2014 - Our big press teleconference announcing the beginning of the Ebola vaccine Phase 1 trial of the Chimp Adenovirus 3 vector with the Ebola GP bivalent gene insert. Trial to start on September 2 at NIH Clinical Center. Also coinciding with slightly later start of monovalent identical vaccine in the UK with Oxford, Wellcome Trust and extension into Mali and the Gambia. Also, we announced our collaboration with NewLink and Public Health Agency of Canada (PHAC) in a Phase 1 trial (in Silver Spring, MD with WRAIR) of the VSV - Ebola vaccine. Much press interest today with appearances on: Fox News Radio; Hearst TV; WTOP; MSNBC with Ronan Farrow; NBC Nightly News; The NewsHour; Cox TV; 24/7 National News Radio; CNN Anderson Cooper; Local Channel 9 News; AP TV.