A single line often inverts meaning once you see what it
answers, so neighbouring messages are always shown.
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August 9 - 24, 2009 - Our clinical trials with the VETUs on the H1N1 vaccine in adults, elderly for dose (15 versus 30 ug) and number of doses (1 vs 2, 21 days apart) began on Aug. 7 just as I had predicted. Clinical trials in children started about 11 days later. We wanted to get some quick and dirty safety data on normal adults before going into children. Will start trials in pregnant women in early-mid September. I pushed hard for trials in pregnant women since they are included in the 5 target groups for HIN1 vaccination in the Fall. We expect first dose data from normal adults in mid-Sept. and second dose data by early to mid-October. This will be just in time since the first major bolus of vaccines will be ready for administration by Oct. 15. Of note, we had expected about 140 to 160 doses by Oct. 15, but the virus is growing slowly pushing back the schedule. Also, one of our suppliers is CSL, which is an Australian company. Since Australia in right now in the middle of their Winter Flu season, they are getting hit hard by HIN] and so the vaccine meant for us is being channeled to the Aussies (appropriately so). Mush press regarding the beginning and progress of the trials. Iam on TV and/or radio and quoted in print media virtually every day. Southern Hemisphere getting hit with many cases and we expect the same in the Fall. Real unknown is whether there will be a greater proportion of serious disease (particularly in the young0 or whether there just will be more cases and so the total number of serious cases will be more without an increase in the proportion. I am on conference call with the Pandemic Flu Task Force (of which I am a member) every day.
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Aug. 26, 2009 -- Sad day today. I was scheduled to appear on CNN's "American Morning" at 6:30 AM broadcast from the NIH TV studio. Was awakened by a call from the CNN producer in NYC at 4:50 AM telling me that the segment has been cancelled Aug 27 -- Sept. 9, 2009 -- Still the same nonsense going on with Jenny backus trying to completely control the HIN1 message and not letting me out to the press despite their insistence on having me on shows and in print. Also, she continues to want to know "what I am going to say" when she does approve me. She is really very bad news. Sept.. 10 - 12, 2009 -- Great news all around regarding HIN1 vaccines. NEJM came out online on evening of Aug. 9 with papers from CSL and Novartis on requirement for only 1 dose of 15 ugs unadjuvanted vaccine (CSL) or 1 dose of 7.5 adjuvanted vaccine (Novartis) for robust responses. NIAID data now showing with SP and CSL product that 15ugs of unadjuvanted product gives robust responses at 8-10 following a single dose in adults (18 to 64) and elderly (+65). This is fantastic and surprising. This strongly indicates that although there is no "measurable" cross-reactivity in serum from most people, particularly the young who have none, this still looks very much like a secondary response to a boost. Therefore, these subjects must have been exposed in the past to virus or vaccine that has primed them for the novel HIN1. So much for measurable antibody being a correlate and/or predictor of immunity/protection. ut In any event, now finally Jenny Backus is "putting me out there" with my leading the HHS press conference on August 11 to make the announcement with the Secretary and doing all of the press, i.e. Newshour, CNN Situation Room, front page NY Times, multiple NPR interviews ("All Things Considered" , etc) Washington Post, all print from everywhere, NBC Today Show, CBS Evening and Morning News, MSNBC, NBC Nightly News, etc. Still and amazingly, she did not allow me to comment on the NIH data on the evening of Sept. 9th when the NEJM data from the companies came out since we were scheduled for a Secretarial Press briefing at 1:00 PM Friday. When the press called me on the night of Sept.. 9 and heard that I could comment on the NEJM papers, but not our data, they went nuts saying that the HHS were crazy and that the story is tonight for tomorrow and not tomorrow for the next day. The Editors needed to know whether the NIH data corroborated the company data; otherwise they were reluctant to play it up. Finally, I e-mailed Jenny, Laura Petrou, and Niki Lurie telling how crazy this was. Jenny finally relented and let me call back the print people to tell them only that "our data corroborate the companies' data", without giving details. Jenny is stupid and nuts. She refused to allow me to go on TV until tomorrow afternoon. Wolf Blitzer would have none of this and on his Situation Room evening show on Aug. 9, he called me directly in my office and put me on TV as a phone-in voice interview. I did not know that he was going to do this until a minute before he did. Jenny was pissed. Yet, the next afternoon and evening and on Sept. 12, Jenny let me do everything. There was, however, a big blowup with crazy Jenny who attacked Patty Conrad and others at NIH since she claimed that we were blaming her for not letting Fauci go on the air (Duh!!!! That is the truth; that is what she is doing). She wrote a vicious e-mail saying that she was very angry because we were "throwing her under the bus" with the press since then they will think that she is muzzling me.....which she is. She really is a crazy lady. Also, we got great news on Sept. 11 that the Thai canarypox (ALVAC) + AIDSVAX (gp120) HIV vaccine trial showed a 31% efficacy that was clearly statistically significant.
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Sept 12 - 17, 2009 -Still an extraordinary amount of attempt to "control messaging about H1N1 on the part of HHS and particularly Jenny Backus. They just have a different philosophy that they control message and a person can only speak about what their official responsibility is, i.e. I cannot talk about trends of disease since this is a CDC issue - the most ridiculous thing I have ever heard of. Also, quite insulting to me sine I have been talking broadly about ID issues for 25 years to national press Obama having real trouble selling his health care reform plan.
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Sept. 17, 2009 - Went to State Department for swearing-in of Eric Goosby as the new head of the Office of Global AIDS Coordinator (PEPFAR+). Took place at 4:00 PM in Franklin Room, presided over by Secretary Hillary Clinton. She recognized me in the audience and made a comment during her official remarks about the great work that I have been doing for so many years with HIV/AIDS. Got a chance to chat with her after the ceremony.
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2009-09-21 00:00
Anthony S. Fauci
Sept. 21, 2009 - More good news. Pediatric H1N1 clinical trials showed good responses at 8 to 10 days with 1 dose of 15 ugs in kids 9 to 17 and lesser response in kids younger - just like seasonal flu vaccine. I led a press briefing.
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Sept. 24, 2009 - Roll-out of the Thai trial results. 31.2% efficacy; p - 0.039. 16,000 in randomized trial in relatively low risk heterosexuals in Thailand. 74 infections in placebo, 51 infections in vaccines. Press ate it up. The usual suspects who wrote the 2004 Science letter criticizing my decision to fund the trial made comments either for attribution or "anonymously" that they were not impressed and probably thought that it was a fluke (John Moore, Ronald Desrosiers, etc.) I was very reserved in putting it into perspective as this not at all being the "end game", but an important start since this was the first time in over 2 decades that we have gotten even the slightest positive signal in any HIV/AIDS vaccine. The lack of major immune parameters, i.e. neutralizing abs and CTLs tell me what I suspected all along that we are probably not looking at the right measures of immunity. Of note the vaccine had no effect on viral load of those that did get infected. Since this was not H1N1 and since Jenny Backus probably does not even know what HIV is, I was given blanket clearance for the Press. I had the most media exposure that I have had since the anthrax situation. Front page or prominent coverage in all major print media (NY Times, Wash Post, AP, Reuters, etc. Also, prominent appearances on every TV outlet - NBC Nightly News with Bob Bazell, CBS Evening News; ABC World News Tonight, Wolf Blitzer Situation Room on CNN; Fox News; Canadian TV; BBC; Bloomberg; World News with Katty Kay; Radio - NPR - All Things Considered; WTOP
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Sept. 29, 2009 - Bono/U2 concert at FedEx stadium. Logistic disaster for me. I was invited by Bono to attend the concert and be present at a reception in the "Round Room" of the FedEx stadium before he was scheduled to go on at 8:30 PM. I was very busy in the office preparing for the visit to the NIH the next day of Sec. Sebelius and President Obama. By the time Chris and I drove to the stadium we got caught in 2 hours of traffic and a disaster trying to get parking in the stadium lots. I missed the reception, did not see Bono. He probably thought that I did not show and so he did not do what he has done several times with concerts and appearances which is to point me out in the audience and praise me. Too bad, but that is the way it goes sometime.
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Sept. 30, 2009 - Wonderful day at NIH. POTUS came in the AM with the Secretary, Bill Corr (Deputy Secretary) and Francis. Marston Linehan and I showed him a lab in the new CRC. First Marston spoke about the genetics of renal cancer and then Francis spoke about the cancer genome atlas. I then spoke to the POTUS about the history of HIV research here in the Clinical Center. I spoke about how I admitted the first AIDS patients in 1981 and how they all died. I then spoke about the major advances in antiretroviral drug development and testing that has transformed the treatment and survival of HIVinfected individuals. I spoke about the recent results of the Thai HIV vaccine trial. He was very engaging, pleasant, funny but serious about the subject. He definitely now has fixed in his mind who I am. When I told him that I had been here since 1968, he joked that this must mean that I came when I was 11 years old. I had the opportunity of walking him back to his limo to drive around the corner to the entrance to Masur Auditorium. We had a very nice conversation. He knew that I was from NYC. I told him that my father went to Columbia and Megan is a 2TM4 year student at Columbia. He said "Ah, I knew there was something that I really liked about you". I told him about Jenny teaching in Crown Heights and he said that this was terrific. All around, he is an extraordinarily engaging person. I rode in the motorcade to Masur Auditorium with Sec. Sebelius. Obama gave a great speech in the Masur Auditorium. He explicitly mentioned me in his speech referring to what I had told him regarding progress in HIV/AIDS. The audience went wild over him. After he left, to return to the White House, I brought Sec. Sebelius to a patient ward 5SE and had a patient presented to her by Joe Kovacs. It was good to give her a chance to see a hospital ward and a patient. After this we took Sebelius to the Medical Board Room and various IC Directors made short presentations to Sebelius: Richard Hodes and Betsy Nabel on comparative effectiveness research (CER); me on HIV/AIDS; Tom Insel on Autism; Griff Rodgers and Betsy Nabel on obesity. All in all it was a great day for NIH. Obama is an extremely engaging person.
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Oct. 7, 2009 -- Went to White House to see Francis Collins receive National Medal of Science. When Obama came into the room, I was in the last row (first one he passed), he came over to me and shook my hand. Clearly he now recognizes me as ASF at NIH. Still major press exposure re: HIN1. I am daily on TV, NPR, print papers. The "ban" on me is clearly lifted as Jenny et al are now very comfortable with my talking about anything. Oct. 7 -- 10, 2009 -- Not unexpectedly, the people who are against the Thai trial are making a big stink (anonymously, of course) by leaking to the press that the original announcement on Sept. 24 of the 31% VE with a p value of 0.039 using a mITT analysis was not the correct analysis since the per protocol analysis is a 26% VE with a nonsignificant p value. Everyone knows that the ITT analysis is the gold standard. Nonetheless, these assholes are trying to invalidate the study by rumor milling the press. They got their information by unethically violating an embargo agreement that they had signed when the DoD (out of courtesy) briefed them on all of the data at the time of the Sept, 24 announcement. Clearly, the people involved are Doug Richman, Dennis Burton, Ron desrosiers, John Moore. I finally spoke to the press and had an article in the Sunday (Oct. 11) NY Times with ny picture explaining why it is much to do about nothing.