A single line often inverts meaning once you see what it
answers, so neighbouring messages are always shown.
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July 2, 2015 - Today I appeared on the Diane Rehm Show where I did somewhat of a debate with Dr. Robert Sears, a pediatrician from California who was concerned about the law recently signed by Gov. Brown in California. On the show with me was Liz Szabo from the newspaper USA Today. In addition, there was a pediatrician who is an expert in parental response to vaccines for their children. Her name is Dr. Allison Kemp. The show went very well and it was clear that Dr. Sears misrepresented certain facts and cherry-picked information for his own advantage. Following the interview, when I got back to my office, I received several e-mails telling me that I did a very nice job in being balanced in my approach. There has been an additional case of Ebola in Liberia. A 17-year-old boy was found dead and was shown by PCR to have had Ebola. Since then, there has been an additional case or two. Therefore, we are concerned that this may be the beginning of another outbreak in Liberia and perhaps in other West African countries. Drew Faust, President of Harvard had e-mailed me a couple of days ago to ask me for suggestions for Dean of Harvard School of Public Health to replace Julio Frenk who had left to become President of University of Miami. I gave her several names and then she responded this AM thanking me and telling me that she had just watched "Larry Kramer: In Love and Anger " (HB0) and this was her comment to me: I spent the evening tonight watching the Larry Kramer HBO documentary in which you figure so prominently--and impressively. The footage throughout is amazing, (I kept thinking what it would be like to have such a record of the Civil War...), and the story both tragic and triumphant. I was powerfully struck by your comment towards the end about how Act Up permanently changed everything in how officials, the state and organized medicine deal with patient communities. The film will remain in my mind for a long time... Very best, Drew
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July 7, 2015 - Met with team from Gilead Sciences who presented data on their new compound GS 5734 that has impressive preclinicakl activity against Ebola. They want our help in testing it in West Africa. It is an RNA Polymerase with activity against MERS, and likely RSV, Chik, and others. We will help them and do a trial in West Africa after we finish the ZMapp trial that is moving along well (47 subjects thus far) in Sierra Leone and soon in Guinea. Infections persist in both countries. Also, last week there was an infection in Liberia with 2 secondary cases. The Gilead people were: Andrew Chang (Head of HIV Therapeutics & Development Operations; William Lee (Head of research); Howard Jaffe (Senior Advisor); and Tomas Cihlar (Head of Discovery Virology). Also, Cliff is back from Guinea and it looks like (despite the continued objections of tom Frieden), we will expand the RCT Vaccine trial into Guinea where there are persistent cases. Had diner tonight at Grapeseed restaurant in Bethesda with the BMGF people who are in town for our yearly joint gates/NIH meeting. Francis Collins and I and Doug owy were the senior NIH people there and Trevor Mundel, Emilio Emini, Chris Carp, Chris Wilson were senior Gates people among others.
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July 8, 2015 -- Attended the joimt NIH/Gates meeting at the Porter Neuroscience Building (Building 35A). Had good discussions with the Gates people about Ebola response, discussing clinical trials for therapy and vaccine. Peter Hull is a solid gates person (used to be with Novartis). Extremely muggy day in DC with intermittent showers. We have had heat followed by showers for many days in a row. Visited the White House West Wing at 3:00 PM to meet with Doug Brooks and Valerie Jarrett. Ran into Denis McDonough, Lisa Monaco and Jack Lew in the West Wing Lobby. Purpose of meeting with Valerie was that I want to convince her to consider advising the POTUS to take on the potential legacy issue of ending HIV/AIDS in the USA. Iexplained to Valerie the recent data on treatment as prevention, and the START study showing early ART is much better than delayed ART for the person getting treated (53% fewer events). This complements the finding from HPTN-052 that early treatment is beneficial to the uninfected sexual partner since it decreases transmission from infected to uninfected partner by 96 percent. Also, discussed the high efficacy of PrEP when taken regularly. Valerie was very pleases with the meeting and said that she would help and bring it up to the POTUS. I do not expect at all that there will be additional money for this. As with the initiation of PEPFAR by me and the early conversations that I had in 2002 with Josh Bolton, I did not ask for anything for NIH; I actually said that the major implementer would likely be CDC, NAPO with me as the "thought leader" and advisor or consultant. She asked Doug to put together a proposal, which Doug would run by me. Before I went into the West Wing, Marie-Paul Kieny called me on my cell and informed ime that the ring vaccination trial that WHO was conducting in Guinea has a positive result with 11 infections in the delayed ring and 0 infections in the immediate ring (P= 0.043). They will stop the study and they already are writing the paper to be published in Lancet. Very interesting since Cliff and I have been insisting that the only real way to go with a vaccine trial is with an RCT with a placebo. My feeling is that this is still the case. However, if you have a vaccine that is close to 100 percent effective, it really does not matter if the trial design is suboptimal. In any event, thank goodness we have a vaccine now for Ebola. Issues now are how and where to deploy it. The vaccine is the VSV from New Link/Merck. Remember, we did the Phase 1 on this vaccine at the Clinical Center. Also. I put her in contact with Bill Dahut (Clinical Director, NCI) to see if we can give her the infusions of monoclonal antibodies here at NIH under the direction of Ken Anderson.
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Jan. 16, 2016 - White House (EEOB - 374) meeting with Deputies chaired by Ron Klain. Subject matter was vaccine trials and if there is any change in approach now that infections are so low, particularly in Liberia. Also discussed indemnification, liability and compensation for trials. Also discussed the need (or not) for 46 hospitals to be "ready" to receive Ebola patients (see above). I have always been against this since, in my mind, most of the hospitals that have volunteered to be "Ebola treatment Units" in the USA are really after the government funds that go with it. The Deputies group was discussing reluctance to tell other hospitals that 46 is enough and we will not support any more. I made myself clear that we should just stop recruiting hospitals that we do not need and that could likely not be able to handle an Ebola patient if they had to. Also, met in the AM with Delegation from India ("Vijay) to discuss NIAID - India collaborations, particularly the Vaccine Action program (VAP), which has been onging for many years. and importantly, a delegation from Liberia and Sierra Leone. The deputy Minister of Sierra Leone (SL) is Dr. Madina Rahman. She definitely "gets it" about the advantage of a RCT and wants to have us conduct such a trial in SL. This is key, since SL is where all the infections are right now with very few in Liberia. I will hook her up with Cliff Lane who is on his way back to USA from Liberia.
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2019-09-09 00:00
Anthony S. Fauci
September 9, 2019 - There is a considerable disagreement going on about the role of randomized placebo-controlled clinical trials (RCTs) in determining the efficacy and true safety of the GSK/NIH chimp adenovirus vaccine. The British in the form of Jeremy Farrar Head of Wellcome Trust as well as the WHO (Marie-Paule Kieny) seem to want to distribute the vaccine outside of a clinical trial. They are responding to what is an emotional need to get some intervention out there even though we have experience to indicate that the worst thing that can happen is the widespread application of the vaccine or other interventions that either do not work or actually paradoxically make things worse as we have seen with the HIV vaccine experience where a HIV vaccine that looked good in preclinical as well as in phase 1 actually increased the risk among the vaccinees of HIV acquisition by up to 41%. This is the worst thing that could happen in the Ebola situation. Cliff Lane and I are trying hard to strike a delicate balance between making our vaccine available following phase 1 trials which have just started here at NIH and continuing to pursue the scientific path of determining if it works and is safe without a paradoxical effect of harming. Had an extraordinary conversation with Tom Frieden tonight. Tom had been at a National Security Council meeting at the White House today hoping that he would guess an indication that they would be many more resources to address the Ebola outbreak. He had been secretive about the meeting; I can understand that since I have been at many WH meetings where they wanted to keep things secret until they made a decision. He obviously was very disappointed after the meeting since he called me on my cell phone in my car as I was driving home late tonight from the NIH. Tom was more animated and distressed that I have ever seen him. I knew this to be the case since he used foul language ("Fucking ....") and I have never heard Tom used foul language before. He was completely frustrated by the fact that his meeting with the National Security Council and representatives from USAID as well as the secretary's office indicated to him that nothing new was going to happen and this whole idea about getting the military involved was really more PR than anything else. He also found out that Cliff Lane in his role as a member of the Defense Medical Board will actually be meeting with Gen. Martin E. Dempsey, Chairman of the Joint Chiefs of Staff, tomorrow (Wednesday, September 10) and he essentially implored me emotionally to get Cliff to emphasize to the Chairmen (General Dempsey) that it is absolutely essential that we have a major military presence in approaching the epidemic in West Africa. We need plans, thousands of beds, trained personnel, Command and control, etc. Without these assets, Tom feels that the epidemic will remain out of control and spread to many countries in West Africa and throughout Africa as well as to other countries outside of the African continent. He also indicated to me that some people who he did not name were telling the military that they need not get involved since vaccines and ZMapp will soon end the epidemic before they even get their planes in the air. This is obviously complete nonsense and Tom knows it. He emphasized the need to please tell Cliff Lane to tell the Joint Chiefs of Staff that this is not the case. Finally, Tom indicated to me that the military are afraid of getting infected because they hear that so many healthcare workers are getting infected. He implored me to tell Cliff that with proper personal protective equipment there really has been no infections among individuals from MSF. This is turning into a very interesting scenario we will see what happens tomorrow on September 10 when Cliff actually meets with the Joint Chiefs of Staff. I assured Tom that Cliff and I strongly feel the way he does and we both have been pushing hard behind the scenes to get the military involved. In fact, I have been talking with Mike Gerson (as has Francis Collins) about approaching John Podesta in the WH to get the POTUS to agree to military intervention. I spoke again with Mike Gerson about this today. After my call with Tom Frieden, I called Cliff and related the story. I did not need to encourage Cliff to say these things since I knew that he would. I got back to Tom and told him that things were on track with Cliff for tomorrow and Tom felt better and thanked me for my help. In addition today I had conversations on the phone with Paul Farmer who was very willing to set up more facilities in West Africa via Partners in Health (they are already in Liberia with Raj Punjabi) together with Jim Kim of the World Bank so that we can do some good clinical work as well as clinical research. Paul indicated that I did wonders with PEPFAR, and that he would like to partner with me to do some good with Ebola.