A single line often inverts meaning once you see what it
answers, so neighbouring messages are always shown.
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August 11, 2014 - The frenzy around Ebola still continues with the major issue being the ethics of getting experimental drugs to the two Americans, and most recently to a Spanish priest who was flown from West Africa to Madrid and who received the experimental zMapp cocktail of monoclonal antibodies. The media are pushing the story of favoritism towards the West and developed nations as opposed to the Africans who are suffering from the disease. They fail to understand that there is no evidence that zMapp actually works, and the fact is that there are only three doses left in the possession of the company that owns it, i.e. MAPP Biopharmaceuticals. Of note, the President of Liberia has contacted the White House to see if the United States can expedite either transfer of two sick Liberian doctors to the United States for care and/or obtain doses of zMapp for them. It is interesting that Larry Zeitlin, the CEO of MAPP Biopharmaceuticals, has contacted Cliff Lane telling Cliff that he wants to get rid of the three doses of zMapp that he has in his possession because of the pressure on him to distribute it to a number of people in Africa who need it. He does not want to be put in this ethically difficult position. He wants to give it to either WHO or MSF. However, he does not want the US government to react negatively to this. He wants to make sure that we do not criticize his giving the doses to another entity, thereby making them responsible for its distribution. We have been having a daily conference call including this past weekend on Saturday and Sunday with Sec. Sylvia Burwell to keep up with the rapidly evolving E bola situation. During that call yesterday (Sunday), Secretary Burwell suggested that since we helped the American doctors to get doses of zMapp that we might suggest to Larry Zeitlin that he give the doses to the Liberians. This would accomplish two goals: 1) it would allow President Obama to respond to the Liberian president, and; 2) it which show the world that we do not just favor Westerners, but that we are helping to make drugs available to Africans. We had a conference call yesterday (Sunday) with Canadian health authorities to inquire about the availability of their experimental VSV Ebola vaccine. On the call were our HHS team with me, Cliff Lane, Hilary Marston, Nicki Lurie, Dawn O'Connell (Sec. Burwell's Chief-of-Staff), Tom Frieden and CDC folks, Robin Robinson, Leslie Dasch (Counsellor to Burwell). On the Canadian side there was Gregory Taylor (Deputy Chief Public Health Officer), Judith Bosse (Assistant Deputy Minister, Infectious Diseases prevention and Control Branch), Theresa Tam (Branch Head, Health Security Infrastructure branch) and Supriya Sharma (Assoc. Assist. Deputy Minister, health Products and Food Branch). The Canadians are still in preclinical studies and have not yet gone into humans. There is an ongoing disagreement between me and Tom Frieden. Tom wants to give the vaccine to health workers in Africa even before it has gone into a phase 1 trial (I believe that he has been speaking with his CDC people who are preparing to go to Africa and are understandably concerned about their risk). I do not believe that Tom understands the clinical trial process since he says that we are "ethically obliged" to allow the healthcare workers to make the decision themselves about whether they are willing to take a potentially unsafe, potentially ineffective vaccine. If this were a drug to be given to a desperately ill patient, then that is one thing about going directly from preclinical to human treatment. However, this is a vaccine to be given to a healthy person. On the call with the Canadians, I pointed out our experience with the HIV vaccine which was effective in monkeys, but in humans it actually significantly increased the risk of acquisition of HIV infection. In order to expedite things Cliff Lane will organize a quick phase 1 trial at the NIH Clinical Center to test the safety of the Canadian vaccine. Once again, I have been all over the press. Last night I was on CNN with Jim Sciutto as well as on CNN International. Today I will do the Diane Rehm Show.
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August 12, 2014 - We are having a daily (including Saturday and Sunday) conference call with Secretary Burwell and a separate call among NIHers with Francis Collins. Press interest in dying down somewhat (I was only on Colombian (Bogotá) radio and Czech Radio only. The issues are centering now around the ethics of using experimental drugs (we actually have none available) and vaccines (getting ready to go into Phase 1 with the NIH (VRC) Chimp Ad3 vector with Ebola env gene inserts) prior to proof of safety and efficacy. The Canadians also have 2 VSV Ebola vaccines. There is no more ZMapp left - 2 courses went to Brantley and Rightbol, 1course went to the Spanish priest who died, and 2 courses were sent to Liberia to treat 2 Liberian doctors who contracted Ebola caring for patients (President of Liberia appealed to President Obama. The USG put Liberia in touch with Larry Zeitlin and MAPP Biopharmaceuticals.
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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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2014-08-15 00:00
Anthony S. Fauci
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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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