A single line often inverts meaning once you see what it
answers, so neighbouring messages are always shown.
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August 26, 2002 - Meeting at the White House with Gary Edson, Jay Lefkowitz, Margaret Spellings, Ken Thomas (ONAP), Jim Capretta, Robin Cleveland (OMB) and Mark Dybul. We presented the condensed version (see above) to Gary , Margaret, and Jay. Several minutes into the meeting Robin and Jim showed up and in a somewhat offhand manner without evening knowing the details of what we were presenting, Robin became very critical of the idea and the project. She actually parroted words that we had heard weeks ago from the Kolbe Committee (Charlie Flichner) about how they were very skeptical that we could actually get "twin pairs" of hospitals. Also, she questioned whether the Uganda model would work even though she knew virtually nothing about it. I kept my cool, was subliminally sharp in response to her, but was very pissed inside. Gary intervened and defended what we had done and indicated that we would come back to Robin with more details about the Uganda model etc. (which we had already done among us previously). Afterwards, Gary, Ken, Mark and I met for about 45 minutes in The Situation Room and discussed further revising of the documents. I would not be surprised if Robin leaked all of this to USAID and the House Foreign Ops Committee. I did not like the way she acted at the meeting and I do not trust her. She acted a bit disrespectful to us in my mind; however, I believe that this was not her intent and she was reflecting the questions that the House Foreign Ops Committee was asking her. te House today: August 26 - Sept. 5 - Much discussion about pre-emptively attacking Iraq to neutralize them before they use or get capacity for "weapons" of mass desctruction. This is pushing our HHS team to be ready to vaccinate the USA population. Our plan for "staged" smallpox vaccination of immediate first responders to broad first responders to voluntary vaccination of general public is ready to go. We are waiting for word from the White House to roll out the plan.
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Sept. 6, 2002 - Two meetings at the White House today: 1) Meeting in Executive Office Building (EOB_ in OMB's Robin Cleveland's office with Robin, Gary Edson, Joe O'Neill, and Mark Dybul. We presented our reenforced implementation with a beautiful computer model of accessibility to central medical centers (CMCs), primary, secondary and tertiary clinics in Uganda as a prototype. Robin was still not entirely satisfied with the presentation since she was hung up on quarantees that this plan would work given failures in previous endeavors in these countries. She and Gary also wanted to flesh out the computer model on India, Mozambique and Guyana. We will go back and try again. Next meeting likely will be with Josh Bolten. 2) Meeting in EOB with General Bruce Lawlor (deputy to Gov. Ridge of OHS), Col Kadlac (OHS), and Col Gerald Parker of Ft. Detrick for me to present to Lawlor the NIAID plan for research including collaborations with DoD and facilities at Ft. Detrick. I presented the NIAID Strategic Plan and Research Agenda. It was a great meeting. Lawlor was extremely impressed and highly supportive. We promised to work together and he offered to help in any way possible. He is a tough, nice , straight shooter. His background is that he commanded a tank battalion in the Gulf War.
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Sept. 17, 2002 - Another meeting at the White House on the President's AIDS initiative. This time I presented the program to Josh Bolten in his office in the West Wing. Also present were Gary Edson, Jay Lefkowitz, Terrell Halaska, Mark Dybul, Joe O'Neill, Robin Cleveland, Kristen Silverberg, Carol Thompson. We are definitely moving along. Clearly Josh wants to do it. He thoroughly liked my presentation. The problem will be OMB and the question of where we are going to get the money. Issue also is if the President accepts it, when can we announce since the budget for 2002 has not even been settled and 2003 has virtually decided. We want to announce soon since WHO and other organizations are dancing around the question of an implementation strategy and we do not want to President to lose the leadership edge. Josh asked OMB (Robin) to work out a budget scenario and get back to him. They also will elevate it up one more notch to Andy Card, Condolezza Rice and Mitch Daniels. We will meet again soon.
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Sept. 18, 2002 - Briefed Secretary Thompson about the upcoming smallpox vaccination policy and role-out. Also present were Julie Gerberding, Stewart Simonson, Michael Osterholm, Jerry Hauer, Les Crawford, Ann Agnew, Terrell Halaska, etc. We are advancing towards the 3 stage policy that ultimately would allow voluntary vaccination for anyone who wants it. Had briefing at the White House on the fact that West Nile Virus can now be spread via blood transfusions (and transplants). We are in the midst of a major epidemic with about 1641 cases and 80 deaths. It has been clearly documentd now that blood transfusions can transmit WNV. We discussed how we would handle the press, etc. I strongly suggested that we avoid the mistakes of the early 1980s regarding HIV and the blood supply. I suggested that we obviously try to avoid panic, but that we make it clear that transfusions are NOT entirely risk free with regard to WNV as well as several other pathogens. It is a question of relative risk of the transfusion versus not getting the transfusion. INCREDIBLE evening - Bono the lead singer of U-2 and the best selling musician in history had called my office yesterday (his chief-of-staff) to say that he wanted to talk to me by phone or preferably in person to discuss how we could partner and how he could help me in my work on trying to get AIDS treament and care and prevention to subSaharan Africa. He had, this past year, gone to Africa in a much-publicized trip with Treasury Secretary Paul O'Neill. At mid-day we got a call that Bono wanted to fly from Chicago to speak with me in person that evening. He did and we met at my house. We had wine, Chris cooked pasta and we had an amazing evening, talking for hours. He is alsolutely fantastic, passionate and very intelligent. He will try to help by supporting me and President Bush in the evolution of our implementation plan for Africa. Also visiting was his staff Jamie Drummond, Lucy Matthew, and Katrina...... We promised to stay in close touch and work together. I did not tell Jenny, Megan and Alison that Bono was coming to the house for dinner. When he walked in the door, they were speechless; however, he was wonderful with them. They (and I) will never forget this extraordinary night.
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2002-09-24 00:00
Anthony S. Fauci
Sept. 24, 2002 - Had CIA briefing and overall review of smallpox plan in Secr. Thompson's office with Gov. Ridge, Col. Bob Kadlac, Julie Gerberding, Jerry Hauer, and a Ridge person . Clearly Russia had modified smallpox and very likely Iraq has smallpox. We reviewed the pre-emptive plan for vaccination that will be presented to Pres. Bush tomorrow by TGT in anticipation that he will make the policy decision soon. We will recommend the 3 stage proceedure of 500,000 to 10 million to the general population. Word in the meeting is that we will definitely attack Iraq by January.
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Sept. 26, 2002 - White House briefing with Carol Kuntz (Assistant to VP Cheney), Kristen Silverberg, Stewart Simonson, Jerry Hauer, Bob Kadlac and others regarding smallpox vaccination policy. Carol was concerned that she was getting different signals from different people about varying toxicities among children versus adults, primary vaccinees versus re-vaccinees. Apparently, D.A. Henderson has been very dogmatic with her (what else is new?). I told her that one can go to the literature and analyze the information in many ways. Since she questioned my numbers, I just kept quite and promised myself to get back to her.
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Sept. 27, 2002 - Spoke with Carol Kuntz over the phone and explained some calculations that I had done (see attachment). She apologized for questioning me the day before and even made the comment that "Who is she to go mano-a mano with Tony Fauci" since I am "a legend" in the White House. I had a great conversation with her and sent the document shown below to her.
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September 27, 2002 NOTE TO CAROL KUNTZ From: Anthony S. Fauci, M.D. Director National Institute of Allergy and Infectious Diseases National Institutes of Health Carol: As per your request, I will summarize below the information that I discussed with you over the phone and will provide as attachments (1 through 5) some data sheets: 1) The question arises whether the rate of serious complications due to primary vaccinia vaccination is greater in children versus adults and whether, because children will be obviously excluded from the cohort of health worker and first responder vaccinees, this will result in a lower than anticipated rate of complications for the first 2 stages of the vaccine program, i.e. up to 10,000,000 people. My reference is Lane JM et al: Complications of smallpox vaccination, 1968. National surveillance in the United States. N Engl J Med 281:1201, 1969. I worked from Table 1 of the paper (attachment #1) and analyzed the "Primary vaccinations". I divided the cohort into 2 groups of <1 yr to 9 yrs old and 10 through 20+ yrs old in order to compare the actual rate per million complications in each group. I found the following: There were 4,900,000 individuals in the <1 to 9 yr olds and 694,000 individuals in the 10 to 20+ yr olds. The rate of complications in the 2 groups were as follows: <1 - 9 y.o. 10 - 20+ y.o. per million Postvaccinial encephalitis 3 1 Vaccinia necrosum 0.4 4.0 Eczema vaccinatum 10 14 Generalized vaccinia 22 26 Accidental inoculation 26 10 Deaths 1 1.44 Therefore, one can conclude from this analysis that the younger group has a higher incidence of encephalitis, but the older group is similar, if not slightly worse off, when compared to the younger group with regard to the other complications of primary vaccination. HOWEVER, the critical issue as I see it is the major difference between previously unvaccinated and previously vaccinated individuals with regard to the frequency of vaccine-related complications. Whether you look at the figures from the 1969 paper referred to above (attachment #2) or the 2001 MMWR (attachment #3), the rate of complications in the previously unvaccinated group is considerably higher than that in the previously vaccinated group. For example, in the Table 6 of the 1969 New England Journal of Medicine paper (attachment #2), the complications per million are as follows comparing previously unvaccinated versus previously vaccinated: Encephalitis - 2.9 versus 0; vaccinia necrosum - 0.9 versus 0.7; eczema vaccinatum 10.4 versus 0.9; generalized vaccinia - 23.4 versus 1.2. The differences are even more impressive in the Table from the 2001 MMWR (attachment #3) 2) Since the differences are so striking between previously unvaccinated and previously vaccinated individuals with regard to the incidence of serious adverse events associated with smallpox vaccination, I calculated the percent of people in the work force that we could predict would be previously vaccinated or not. I used the most recent US Census (2000) (attachment #4). I consider the work force to be individuals from 20 through 64 years old (this corresponded to natural breaks in the census data). In 2000, there were 281,421,906 people in the USA. I found that there were 59 million people or 21% of the total population and 36% of the work force between the ages of 20 and 34 years. These people will have not been previously vaccinated. Routine vaccinations stopped in 1972 and most children would not have been vaccinated before age 5 and so 34 years old is the cut off point. I further found that 107 million people between the ages of 35 and 64, i.e. 38% of the population and 64% of the work force were likely vaccinated. Thus, 64% of the people that we would be vaccinating in the first responder/health care worker category would fall into a group that historically has a much lower rate of serious adverse events than the previously unvaccinated group. I believe that this must at least be taken into consideration in our policy decisions. 3) You asked a question about residual immunity in people vaccinated decades ago. If you look at laboratory immunity (i.e. antibody levels and cell-mediated immune function), there is no question that the vast majority of studies indicate that there are variable levels of residual laboratory immunity in people who were immunized even decades ago. The question remains whether the laboratory immunity is totally reflective and correlated with clinical immunity to an actual exposure. There are several studies that indicate that previous immunization, even decades ago, provides real, but variable, degrees of protection against death (i.e. lower case fatality rates) compared to unimmunized individuals. It is impossible to determine the effect on actual infection without death. Some of these studies such as the 1902-1903 Liverpool outbreak study is partially flawed in that there was some smallpox circulating in the community that might have boosted immunity. However, several studies that are summarized in a paper by Mack TM et al: Smallpox in Europe 1950-1971. J. Infect. Dis. Vol.125, number 2, Feb. 1972 (attachment #5) indicate that case fatality rates are significantly less in individuals vaccinated even more than 2 decades before. I personally do not believe that all of these people were protected because that were intermittently boosted by naturally occurring San smallpox. There just were not that many widespread smallpox outbreaks to boost the population of Europe consistently during that time frame. In fact, from 1950 through 1971, there were only 680 cases of smallpox in the countries in question. Therefore, I would have to conclude (not definitively, but likely) that previously immunized people do have a variable, but significant, degree of residual protective immunity against death from smallpox. I hope that you find this information useful. Please give me a call if you have any questions at (301) 496-2263. Thank you and best regards. Sincerely, Anthony S. Fauci, M.D.
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Sept. 29, 2002 - Received ICAAC Award and gave the ICAAC Award lecture in San Diego on "Bioterrorism in the spectrum of emerging and re-emerging diseases". Audience was 10,000 people and received rave reviews for the lecture.