A single line often inverts meaning once you see what it
answers, so neighbouring messages are always shown.
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August 30, 2014 - Case from Guinea went to Dakar, Senegal and lied about exposure. Took bus and stopped in 2 health care facilities. Contact tracing now going on in Senegal. Spoke with Tom Frieden who is in Liberia. Trying to get him to appreciate that giving VSV Ebola vaccine as post-exposure prophylaxis (PEP) is risky due to the induction of cytokines by the live VSV, which might actually enhance the acquisition upon exposure since cytokine dysregulation plays a negative and potentially positive role in Ebola virus disease. He wants to pre-position VSV vaccine for PEP and TKM drug (siRNA - not yet is phase 1) at all Ebola treatment Units (ETUs). I understand the desire to protect the CDC and other health care workers on the front lines, but we must be concerned about giving drugs/PEP vaccines BEFORE they have even been in the earliest Phase 1 trials. Yesterday CDC evacuated a WHO worked who had a low risk needle stick (clean needle through potentially contaminated gloves) and they gave the person TKM drug and wanted to give VSV, but could not get it. That is why he now wants to pre-position it. See below my e-mail to Tom Frieden sent to him on Sunday, August 31 while he was in Liberia: Tom: I am including a few attachments: 1) 2 slides (from Nancy Sullivan who does our pre-clinical Ebola studies) that summarize the issue of "cytokine dysregulation" in Ebola disease and potentially following vaccination; 2) 2 reprints (referred to in the 2 slides) on the types of cytokine responses in Ebola disease and following vaccination with different vaccine platforms; and 3) the Heinz Feldmann paper with which you are familiar and which shows that in the monkey model of Ebola virus disease, the VSV Ebola vaccine used as post exposure prophylaxis (PEP) protected 50% of the monkeys from lethal challenge with Ebola if administered 20-30 minutes following the challenge. Getting back to our discussion and your question concerning the issue of any risk of administering VSV as PEP, I certainly would not characterize the inflammation following VSV vaccine administration as "cytokine storm". It certainly induces inflammation and can cause fever. Note that the only human to my knowledge who received this vaccine was the laboratory worker in Germany who had a needle stick injury and she got a fever following vaccination. Inflammation that results in fever will virtually always induce secretion of cytokines of various sorts. Since VSV in the NewLink vaccine is a replicating virus, it will almost certainly induce the secretion of cytokines. The reason that this might be important is that a whole array of cytokines are important in the pathogenesis of Ebola virus disease. It certainly can kill you (advanced cytokine storm) and it is almost certainly involved in protection and recovery from Ebola infection. It is a delicate balance that we do not fully understand. At this time, we are unclear about the positive versus negative effects of cytokine secretion (or call it dysregulation) related to the precise cytokines in question and the timing of their secretion vis-à-vis Ebola infection (see first bullet in the first of 2 slides in the first attachment. In my mind, this does not mean that one should not provide VSV as PEP for your people (or others); however, if administered to them, it should be made clear to the recipients that 1) VSV Ebola vaccine provided 50% protection in monkeys if given 20-30 minutes following exposure. I would mention that monkey models are somewhat different from human Ebola (see 3rd and 4th bullet of 2nd slide in first attachment) and so direct extrapolation to humans should be made with caution at this point in time; and 2) importantly, the vaccine recipients should clearly understand that there is a theoretical possibility that the VSV, due to the complexities of the cytokine dysregulation that accompanies Ebola infection and the perturbation of this cytokine network that might occur with a live virus vaccine (VSV) that induces inflammation and fever, might actually cause them harm by disturbing their normal inflammatory/immune response to Ebola infection. If they understand these caveats, then it would be their choice to receive the vaccine with informed consent. Finally, as you certainly know better than anyone, the FDA will have to be involved in the approval of allowing this pre-positioning and potential use of an experimental vaccine by whatever is the appropriate regulatory mechanism. I hope that this information is helpful to you in your deliberations about PEP. I look forward to discussing these issues with you. Best regards, Tony -----Original Message-----
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Sept. 1, 2014 - Labor Day - had usual call with Secretary Burwell (SMB) this AM at 8:30 AM. Clear and muggy day. We are going around in circles. I am concerned that the Secretary is a really smart and very competent person, but she is surrounded by people who may be good at management, but who have never been in a situation like this and who really do not have a clue how to address it → Leslie Dach (formerly of Walmart); Andrea Palm (have no idea where she came from). Bill Corr (Deputy Secretary) is the only one with corporate memory of former crises and he has been completely marginalized by the new kids in town. There really is no command and control at a higher level. At my suggestion, Francis sent a note to SMB suggesting that we bump this up to the White House level (perhaps the VP) in order to get DoD, USAID, HHS, and NSC working together. She has not yet responded to him. I mentioned on the call today that Tom Frieden is dealing with Assistant Secretary Lumpkin of DoD. He is a good person, but nothing is happening with the promise for mobile hospital beds. They are still quibbling about a 25 bed hospital when they really need 1000 beds. Plans for 5 X 100 beds have gone nowhere. My experience with the DoD is that they are well-meaning, but the culture and chain-ofcommand is such that you never know when you are speaking with someone who really has the authority to actually do what they are talking about. Something strange about the military culture in that they will never say "you are speaking to the wrong person; I cannot help you". They will try to help (although they cannot) and all that happens is that time is wasted. I tried to make that point on the conference call. Importantly, WHO is saying that the epidemic could reach 20,000 cases. In fact, mathematical models that came out in ScienceInsider today from a physicist named Alessandro Vespignani showed that the curve is exponential, not linear, which means that there could be 10,000 cases by September 24. This is turning into a total catastrophe. Just spoke with Dawn O'Connell (Counsellor to SMB) and explained to her that the situation is out of control and that we need a higher command and control. I also explained to her the importance of the "exponential" curve of the epidemic. Dawn is really trying to be helpful.
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Sept. 2, 2014 - Tom Frieden back from West Africa, gives press conference and says that the situation is out of control and could result in 100,000 cases! HHS people concerned that he is being hyperbolic; I do not think that he is hyperbolic. Worrisome things - an American missionary M.D. got infected while got infected in Liberia in a hospital that was not for Ebola patients. Turns out he was doing an OB-GYN exam on a woman who was infected, but did not know it and did not tell the missionary that she had been exposed. Big problem - people are not telling the truth for fear of stigma. Epidemiological curves are now exponential. A lot of planning, but not much action. I am supporting Tom in the press and at HHS even though he still thinks that we should pre=position TKM drug (siRNA) and VSV vaccine for PEP for health workers in the ETUs even though they have not been in Phase 1 yet. Did Panel at CSIS on 1616 Rhode Island Avenue. Very hot muggy day. Panel on Global Health issues in the context of Larry Gostin's new Book of Global Health Law. Panel was me, Larry and Tim Evans of World Bank. Ebola was a major topic. Important - Secretary Sylvia Burwell called my cell phone at 2:30 PM to ask my opinion of whether we were not doing enough or were doing it wrong. I told her that quantitatively we are not doing enough. But as the epidemic grows exponentially, then the quantitative defect transforms into a qualitative defect and then we are doing it wrong since doing the same thing minimally while the epidemic grows, then becomes doing it wrong. She also tasked me to find out whether there are options to improve the tobacco plant yield of the ZMapp antibodies or as suggested by some, that we go to CHO cells. She wanted me to contact the Agriculture people at the BMGF where she used to work to get their opinion. I called and spoke with Susan Hellmann (President of BMGF), Chris Elias (BMGF), Rob Horsch (Ag expert at BMGF), Larry Zeitlin (CEO of Mapp Biopharmaceutical to get their opinion. Consensus is that it will take too long to fix the poor yield in tobacco and that we should go for CHO in 2 of the 3 antibodies. The 3rd does not do well in CHO and so stick with tobacco on that one. I wrote a long e-mail to Sylvia explaining this. Press - CNN with Erin Burnett News still dominated by ISIS who beheaded another USA journalist; Russia invading eastern Ukraine; Gaza and Ebola
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Sept. 3, 2014 - Big meeting at World Bank Headquarters on 18th Street, N.W. to exam and discuss the response to Ebola. Jim Kim (President of World Bank) specifically invited me (as did Paul Farmer), Discussed the WHO Roadmap and David Nabarro's UN Plan. Present at meeting were: Tom Frieden, Jim Kim, Tim Evans (Senior Director, GHNDR), Jan Eliasson (Deputy Secretary General, UN), Margaret Chan (DirectorGeneral, WHO), Gayle Smith (by phone - Special Assistant to the POTUS at NSC), Mark Dybul (by Phone), Keiji Fukuda (WHO), Raj Panjabi (Harvard), Ariel PablosMendez (USAID), Jimmy Kolker (HHS), Joia Mukhajee (PIH)Sri Mulyani Indrrawati (World Bank), Olusoji Adeyi (World Bank), and other World Bank people. Jim Kim took the lead and emphasized that we need to translate "planning" into action and took Margaret Chan to task for not exercising her authorities under the International Health Regulations (IHR) to take the lead. Despite Jim Kim's strong urging, it still appears that we are not headed to great action. David Nabarro had some action items with no way to actually act. I mentioned gently to Margaret that she should not say that "We plan to have to Epidemic under control in 6 months" since this would signal to the world that we actually have a way of ending it in 6 months, when in fact we have no idea when it will end given the exponential nature of the increase in cases. I also told story of when Colin Powell and I went to the UNGASS in the early 2000s and he declared the AIDS pandemic a global security threat and this got the attention of everyone. We should do the same thing with Ebola. Press - MSNBC with Peter Alexander; Fox News with Lou Dobbs.
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2014-09-04 00:00
Anthony S. Fauci
Sept. 4, 2014 - After discussions with me and having me see and edit his column, Mike Gerson wrote a scorching editorial in today's Washington Post criticizing the world and the White House for not doing more for the Ebola situation. In my discussions with Mike, he indicated that when he was in the WH with Josh Bolton as Chief-of-Staff, they would have pushed George W. Bush and he would have responded to do something dramatic to help West Africa. Mike sent me a note that Denis McDonough (Obama Chief-of-Staff) sent to Mike in response to Mike sending Denis a copy of the article. Denis note to Mike below: y the following: Tony, In confidence, this is the note Denis sent back to me when I sent him the link to the column. I thought you might be interested. Thanks, Michael. It is good to hear from you, and I look forward to reading your column (which I have not yet had the chance to do but will soon). I did think it was worth mentioning that the President had a good - if alarming - discussion with Dr. Frieden on Monday after Tom returned from the region where he went to get a candid view of how this is progressing. Tom was concerned with what he saw, and the President was concerned with the same. As a result, POTUS directed even more aggressive action than we have been taking so as to treat this like the national security challenge it is. Lisa, who is leading this effort, and John may have additional thoughts. But we feel this urgency - deeply. Thanks again for the note, Denis. Press - MSNBC with Ronan Farrow,
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Sept. 5, 2014 - Got note from Tait Sai saying that my interview in Newsweek where I said that the Epidemic was "completely out of control" was "10% too hyperbolic". Lots going on. USAID assigned Nancy Lindborg to run their shop. She is pretty good. Jim Kim is exercised that WHO is not doing enough. Tom Frieden says that the DoD is useless since they can never commit to anything. This is interesting since Cliff Lane thinks that they are the only ones that can control this with Command, Control and Communications. Jim Kim wants to engage me, Paul Farmer, Mark Dybul to see to the clinical care issue and incorporating clinical trials into the picture. Spoke with Tom Frieden today and Tom feels better those things are now moving with the $75 million that USAID is putting in. I believe that Tom was told to tone down the rhetoric about this outbreak being totally out of control and that is why he is saying that things are on track. This coincides with Tait telling me that I am 10% too hyperbolic Did boat-load of print media today.
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Sept. 7, 2014 - POTUS said on Meet the Press today the following: POTUS on Ebola on Meet the Press, 9/7/14: *Americans should not be concerned about prospects of contagion here in US, shortterm, because it is not airborne disease like the flu. *No public health infrastructure in Liberia/SL/Guinea. *What should be containable problem is breaking loose, because people aren't being quarantined properly, people aren't being trained properly, not enough public health workers. *We have to make this a national security priority. Mobilize international community, get resources in there, get US military assets just to set up isolation units and equipment, and provide security for public health workers surging from around the world. *If we do that, still going to be months before this problem is controllable in Africa. But it shouldn't reach our shores. *If we don't make that effort now, and this spreads, not just through Africa, but other parts of the world. There is the prospect the virus mutates, it becomes more easily transmittable. And then it could be serious danger to US. *This is example of where US leadership is important in dealing with crisis. But, also argument for when I go before Congress, and say let's give some public health aid to Liberia. Short term investments now, pay off in the future. It now remains to be seen what actually happens. The POTUS is getting beaten up in the polls and by the GOP for his inaction. He let the Left down by delaying action on immigration reform until after the November Congressional elections in a purely political cave-in. He is paralyzed in inaction on bombing ISIS in Syria and in doing nothing to stop Putin and the Russians from taking over part of Ukraine. He is having a bad summer. Yesterday, Mike Gerson contacted Francis Collins in the same manner that he had contacted me, asking Francis what he thinks should be done. Francis responded as I did that we should bring in the DoD for their Command, Control and Communications capability. Also, someone needs to be in charge. John Podesta (Counsellor to the POTUS) contacted Mike Gerson asking him what he thinks we should do. John was taken aback by Mike's Post editorial the other day. Mike asking Francis/me who should be put in charge at the WH. I suggest any of the following: David Petraeus, Stanley McCrystal, Colin Powell, and Bill Frist. I doubt if they will choose any of these. They probably will ask Lisa Monaco - head of NSC. We really need a General. I believe that we are missing the boat. USA is missing an opportunity of saving many lives and coming across as the savior of West Africa, much like George W. Bush saved all of Africa with PEPFAR. Am getting e-mail from Jim Kim and Paul Farmer asking for my help/advice should they get more heavily involved.
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Sept. 8, 2014 - The situation is evolving rapidly where the Department of HHS is now telling us (NIH and others) that things are now going in the right direction and that we do not need to have daily phone calls anymore and could probably move them to every week or every other week. This is stunning to me since I do not see that anything has really changed and it appears to me that they are trying to paint a rosy a picture when things are actually getting worse. The reason for this is unclear. It could be that the White House has told them to tone down the rhetoric since they do not want to put pressure on the President. Also amazing is the fact that even Tom Frieden has told me on the phone that things seem to be going in the right direction now and they have work streams and points of contact and he is much more optimistic. I cannot believe that he has completely changed from the passionate person demanding an overwhelming amount of resources and beds to someone who now says everything seems to be going okay. There is something very fishy here. I suspect that HHS has promised him that resources are on the way and have told him to cool it. I will find out what is going on. Appeared on Diane Rehm show today with Sheri Fink from the New York Times as well as Sophie Delaunay from MSF and Mvemba Dizolele from the Democratic Republic of the Congo. Dvemba said that he has been reading about me since he was 16 years old and that I was his hero. He made me feel rather old despite the flattering comment (he is right about the age ). The host was Steve Roberts and we spoke about the drastic situation in West Africa. Also appeared on BBC radio. WTOP radio and Reuters TV. Although the President has said on Meet the Press that the military will now be involved, reports and news outlets such as Reuters quote officers at the level of Colonel saying that the military will deliver the 25 bed hospital to Liberia; however, there will not be "boots on the ground" of military personnel staffing the hospital. As far as I can see, this is no different than what was going on before the President's announcement. There were already plans to get a 25 bed hospital shipped by military aircraft to Liberia. I think this is a smoke and mirror game in which nothing will get done.
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Sept. 10, 2014 - The debate still continues as to whether or not we will have military assistance in dealing with the Ebola epidemic in West Africa. There is a disturbing lack of transparency between HHS and us here at NIH in that they are obviously negotiating at the level of the National Security Council and the Department of Defense about what to do in the epidemic without telling Francis Collins or me what is actually going on. In the meantime, Cliff Lane as a long-term member of the Medical Defense Board of the Department of Defense has met with Gen. Martin E. Dempsey, chairman of the Joint Chiefs of Staff today. Cliff relates to me that Gen. Dempsey seemed quite receptive to Cliff's pleading for a massive military logistic support for the Ebola situation in West Africa. Also at that meeting with the Joint Chiefs was Laurie Garrett, because of her prior experience with Ebola epidemics. According to Cliff, Laurie also pleaded for a massive military effort. It should be noted that today another important event occurred in which the President announced at a TV appearance that he will initiate a scaled up military attack on ISIS (he calls it ISIL) including their assets in Syria. He declared that ISIS is a threat to the Middle East, the surrounding regions, and the United States and Europe, largely due to the fact that they have publicly said that they will attack Western nations. This is a particularly important problem because many Westerners with Western passports and Visas including those from the United States have joined ISIS. The President stated that he would not include ground troops in this effort. However it is clear that Special Forces will be needed to guide the air attacks. The press is sharply criticizing the POTUS for having no plan, missing prior opportunities, and now doing too little, too late. More later. I bring this up because this is certainly a complicating issue when you are also asking the military to help with Ebola outbreak. Had a momentous evening today in that I gave a keynote lecture at the PhRMA Research and Hope Awards Gala at the Mellon Auditorium on Constitution Ave. It was particularly important because the other speaker was former Pres. George W. Bush. We resumed our warm personal relationship in that when he entered a small room of VIPs to shake hands and take pictures as soon as he walked into the room he caught my eye and said out loud for everyone to hear: "Hey, Tony it's great to see you". He gave me a big hug; we took pictures; chatted a bit and then when he was on the stage for his talk which was actually a conversation with a moderator, the first thing he said is that: "We have with us tonight my friend Tony Fauci. I gave Tony the Presidential Medal of Freedom several years ago. I did that because you should know that he is one of the most important American heroes of our time." It was extraordinarily flattering, but this is exactly the way he has been treating me for years. The talk that I gave was entitled ending the HIV-AIDS pandemic: a realistic goal. Overall the evening was very pleasant. I sat down next to my old friend form NIH director Elias Zerhouni and the evening was full of warm praise by many people for me and what I have been doing with HIV over the last many years.