A single line often inverts meaning once you see what it
answers, so neighbouring messages are always shown.
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Nov. 5-6, 2011 - Continued strain between USAID (Raj) and PEPFAR (Eric and Charles) in that Raj just does not want to give in about pushing for "doing things differently". Nov. 5-6 is the weekend and Department of State (Lorrie McHugh - communications) as well as Cheryl Mills are lining up people (activists, etc.) to write blogs in anticipation of Sec. Clinton's Speech at NIH. Her speech (which I have been deeply involved in writing follows the PEPFAR model, not the USAID model. They have asked me to do an editorial for the NY Times giving the scientific basis HRC's speech. I worked all weekend and got a great piece which I have circulated to Cheryl Mills, Burklow (NIH), HHS, etc.
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Nov. 7, 2011 - Full court press in preparing for Clinton visit and speech. Again, I get call from Raj Shah wanting me to support his "doing things differently". I believe that he really does not fully understand what PEPFAR is trying to do. He wants to scale up heavily in high impact countries and not go for just scaling up prevention and TAP. We are too far down the pike to change now even if we decided to change. Hillary's speech is tomorrow as is the White House Principal's meeting in the Situation Room. Ariel Ramos seems more convinced that the PEPFAR model will work now that he has examined the models more closely; however, Raj is still skeptical.
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Nov. 8, 2011 - Beautiful, crisp, sunny Fall day! Fabulous event with Clinton visit. Francis and I greeted her at the South entrance of the NIH Clinical Center. Also waiting in background was Harold Varmus and Nora Volkow. Warm and engaging conversation with HRC. I showed her a picture of her and me at the Clinical Center during her first visit in Feb., 1994. I welcomed all of the dignitaries to the Masur Auditorium, said some warm words (see files) about the relationship between HRC and me and then introduced Francis Collins who introduced her. She gave a great delivery of the speech that I helped write. Overwhelmingly positive response from audience and press and bloggers immediately after. I sent in my Op-Ed to the NY Times (see files) and then went to White House for Principals Meeting in Situation Room at 3:45 PM. Present were: Hillary Clinton, Jack Lew (OMB), Denis McDonough (NSS), Chaired by Tom Donoline, Samantha Powers, Tom Frieden, Raj Shah, Eric Goosby, Gayle Smith, Ariel Pablos-Mendez, etc. We agreed upon Option #2, which is greater efficiencies to provide more $ and scale-up of non-Tx prevention as well as increasing the PEPFAR target for prevention to 6 million by 2013 and 8 million by 2015. I stressed to Tom Donoline that the POTUS should strongly call upon more involvement by other donors, particularly China. He agreed. Of note, Susan Rice teleconferenced in from NYC and she voted strongly for Option $3 (Blue Sky), which would require an additional $2.5 Billion. This is a good sound bite, but Jack Lew pointed out that given the budget situation, the POTUS would have to back off on commitments that he has already made to other programs in order to do this. Hillary pointed out that this was not tenable. She also pointed out that we needed to address the ADAP waiting lists. Amazing situation. After returning from the White House, I heard from Courtney Billet and Greg that HHS contacted us and said that although they had no problem with the Op-Ed (see above) and actually cleared us to send it to NY Times, the "White House" told HHS to have recall the Op-Ed since it is "off message". Still not sure what they mean since State, HHS and everyone else approved it. Could be because I called for more resources as well as more "efficiencies" Another amazing situation - At around 7:00 PM, Raj Shah calls me up and asks me to call a meeting with him, Eric and me to see if we could modify the proposal that was agreed upon at Principal's Meeting!!!.. He still insists that the POTUS needs to come out with something "different" and suggests using "pipeline" money from PEPFAR/USAID. He wanted me to broker the meeting. I contacted Eric and bless his heart, he is willing to meet. Meeting scheduled for 8:30 AM in Eric's office tomorrow.
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Nov. 11, 2011 - I call Eric and Tom and explain situation with Raj. I convince them to give it one more try. Both are extremely skeptical, impatient and wary of Raj. However, I indicate that we must ask Raj to be very specific in what he wants to do and how he wants to do it and where are we going to get the money. Raj has always been very vague about all of these issues. He just keeps saying that what Eric is proposing is old stuff and incremental and that he wants to suggest to the POTUS something big and transforming. I will write an e-mail and detail the conditions of another teleconference and/or meeting.
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2011-11-15 00:00
Anthony S. Fauci
Nov. 15, 2011 - At the invitation of Alan Murray (Senior Editor of Wall Street Journal) I spoke at the Wall Street Journal-sponsored CEO Council event at The Four Seasons in Georgetown. My purpose was to convince the CEOs to get involved in supporting financially and otherwise the Global AIDS Pandemic activities. They were OK, but somewhat clueless about the importance of global AIDS. In retrospect, billionaire philanthropists would be a better audience. That evening went to a reception at Bill Heseltine's house for Geena Davis. She remembered our prior discussions during her visit to NIH. She is lovely - very tall, but lovely.
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Nov. 19, 2011 - Gave Keynote Address at the Caribbean AIDS Conference in The Bahamas. The Atlantis Hotel is surrealistic.
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Nov. 21 - 30, 2011 - Spent hours on the phone trying to address the ADAP waiting list since we (HHS/PEPFAR) felt that if the POTUS announces a scale-up of treatment for PEPFAR, then the logical question is what are we doing about the ADAP waiting list? Tom Frieden suggested that we engage the drug companies. Since I know Jim Rooney from Gilead, I made the initial contact which led to many phone calls involving Jim and people from Gilead; people from HHS - me, Tom Frieden, Mat Wakefield (HRSA), Sally Howard (chief-of-staff to Sebelius), Dora Hughes as well as people from NASTAD and Welvista. Important issues is the Gilead agreed to greatly lower their prices for people on ADAP waiting list Dec.1, 2011 - World AIDS Day (WAD). A very special day. The White House has decided that the venue for the POTUS statement on WAD would be George Washington University in a program sponsored by One and RED, Bono's organizations. Sanjay Gupta was the MC. We had Presidents Bush and Clinton by live video conference and President Obama delivered the speech that Eric Goosby, Tom Frieden and I and others wrote for him. As expected, he went with Option #2 (see above - Nov. 8, 2011). In addition, he included an additional $15 million (for Clinics) + $35 million (for States) = $50 million for ADAP total. Again, Tom Frieden and HHS people (see above) have been working on the "domestic option" for the past couple of weeks to offset criticism that we were paying attention to global, but not domestic AIDS. Following the POTUS speech, there was a panel moderated by Sanjay consisting of Bono, Alecia Keys, Kay Warren, Rep. Barbara Lee, Sen. Marco Rubio and a few others. I was told a few days prior that Sanjay would turn to me with a question sometime during the program. Right after Pres. Clinton's live video speech, Sanjay said that you cannot have a discussion about HIV/AIDS without including Tony Fauci (who is in the audience) and his perspective on the science and he turned to me to speak. I spoke for a few minutes about the fact that the scientific data were overwhelming (circumcision; treatment as prevention, etc.) and the task now was to implement the science. The statement was similar to what I had said at the IAS meeting in Rome in July. Right after my comment, Bono said that he must tell a funny story and he proceeded to describe the night when he came to my house for dinner to discuss what we could do to push the global AIDS agenda. He was cute. He said that his friend Bobby Schriver told him that the only person that could break the logjam on Global AIDS programs was Tony Fauci. He finished by calling me a "proper hero". A YouTube record of this statement by Bono is available for Dec. 1. Also, I had a chance to say a few words to Pres. Obama as he was "working the line" following his speech. He congratulated me for the great work that we were doing and that he has been hearing about. All in all, a really good day!! Of note, Gregg Gonsalves wrote a scathing letter to Raj Shah (that went viral on the internet) scolding him for obstructing the treatment as prevention initiative (see above discussions re: Raj). Unclear to me how Gregg found out about all of this. Dec. 2,, 2011 - Finishing off WAD activities, went to Harvard on a beautiful crisp clear December day and participated in the AIDS@30 International Symposium. I gave the keynote "Perspective" on vaccines and participated in a panel Chaired by Bruce Walker and consisting of Bob Gallo, Nelson Michael, Jerry Sadoff, and Julie McElrath. Flew up to Boston with Eric Goosby and flew back to DC with Nelson Michael. All good. Dec. 2 thru 21, 2011 - Significant issues regarding dual use research. Check press from Dec. 20-21, 2011. Briefly, NIAID funded 2 studies - subcontract via CEIRS (Centers of Excellence for Influenza Research and Surveillance) to Erasmus University in Netherlands (Ron Fouchier) and grant to Yoshi Kawaoka at Wisconsin to study feasibility and mechanism of getting the highly lethal (60%), but poorly transmissible H5N1 (bird flu) that has been smothering in SE Asia since 1997 to become transmissible and maintain lethality in a mammal model (ferret). Rationale for the study was to determine - Can it happen (in mammals) since many people reasonably assume that it cannot since it has not done this in nature despite being around in chickens and rarely in humans since 1994? Also, if it does become transmissible by point mutations followed by passaging in ferrets (the experimental methodology), then what is the signature of it so that health officials in the field could do better surveillance and also design better diagnostics, therapies and possibly vaccine. Both papers (with slight differences found that relatively few mutations (~5) followed by serial passage in ferrets led to virus that had better transmissibility and kept virulence. Kawaoka paper showed increased transmissibility but not maintenance of virulence, while Fouchier paper showed both. Papers submitted to Nature (Kawaoka) and Science (Fouchier). Program staff (NIAID), Fouchier and editors asked (because of possibility of dual use) the NSABB to examine the results and advise if it was OK to publish. Kawaoka was asked by NIAID to do the same. To everyone's surprise, the NSABB recommended that the papers be published with the conclusions, but with redaction of the key results, mutations and methodologies. I believe that this was group think and "cover your ass". Decision was to do this and provide a link in the paper whereby people (health officials, legitimate scientists, PHARMA, etc) who have a need to know can have access to the data. This was a precedent setting recommendation that was virtually impossible to ignore even though I disagreed with it since the complexity of influenza adaptability is extremely complex and it is unlikely that terrorists could replicate this work largely because it is unlikely that if that this model just simply predicts that it will maintain these characteristics if taken from ferret to human. Furthermore and more importantly, since the data had already been presented (by Fouchier) at an international meeting in Malta and the papers were reviewed by several reviewers and known by many, the data are already "out their" and would be virtually impossible to "restrict" the access to the full papers by a "vetting" mechanism of people who "apply" for the unredacted papers. Journal editors were disappointed (Bruce Alberts - Science and Phil Campbell - Nature) as were many flu scientists. However, we heard the usual hysteria from people like Ebert and Ingelsby who complained that the experiments should never have been done in the first place. Also, Mike Osterholm who is a member of the NSABB was practically hysterical that the NSABB recommendations should go out right away so that he could "answer all of the press calls" that he was getting. In reality, the only press that was agitating was - you guessed it - Laurie Garrett. Of note, Mike Osterholm is the Head of the CIERS group that subcontracted through the Mount Sinai group to Fouchier to conduct these experiments. Osterholm now (incredibly) says that he never thought that this situation would arise when he knew about the contract and actually was given updates through the CIERS on the actual data. Yet, he is the loudest one saying we should now lock down all experiments and treat this like BSL-4. Problem here is that as I predicted, the White House is now involved and they want the USG to examine all research that is ongoing and that is proposed for its dual use potential and to put restrictions on it if it has such potential. What they do not understand it that in the "discovery of science" you cannot always predict what will be dual use and the danger is that scientific work and importantly the normal open discourse of science will suffer because some uninformed people who live for "intrigue" are acting out their own agenda. More later. Dec.22, 2011 to Jan. 7, 2012 - Situation has escalated with wall-towall conference calls with HHS and a variety of WH folks about what to do. Major issues are that Bruce Alberts and Phil Campbell are willing to publish a redacted version of the papers in Science and Nature, respectively; however, they insist that the USG have in place a link or some mechanism that they can publish with the redacted versions of the paper that would allow legitimate scientists and Public Health officials to have access to the entire manuscript. I found out through painful probing that recommendations from NSABB guidelines USG policy should have been in place years ago to deal with the upstream (prior to the start of experiments) and downstream (progress reports and communication of results) issues of Dual Use Research of Concern (DURC). Problem is that the recommendations of the NSABB as to the "7 deadly sins" of DURC never got "clearance" from the multiple agencies to which NSABB officially reports (DoD, DHS, DoS, DoJ, intelligence community) in order for it to get the Public Comment in the Federal Register to give the scientific community the opportunity to weigh in on the feasibility of controlling or not such research at the same time a preserving the fundamental basis of open scientific discourse. I believe that Amy Patterson should have shown some greater strength of leadership to make sure that this process moved along, when in fact it just froze. The NSABB sent in their recommendations in 2007 (NSABB started in 2004) that should have become guidelines USG Policy that ultimately could guide the local institutional Biosafety Committees (IBCs) to monitor this at the local level. Irony is that now the papers have been reviewed, the Fouchier paper was presented in an international meeting in Malta and multiple people have seen the data. BTW, Fouchier has been acting like a jerk in his cavalier attitude about disseminating the results. Now NSABB and the journals above all want a mechanism is a few days (to coincide with the publication dates of the papers (Jan. - Feb. 2012) that they have not been able to do in 4-5 years. All of the demagogues have weighed in. People thinking that the world is not in danger of a terrorist making a "killer virus" that spreads easily. What is at stake is the proper balance of doing microbial research that has DU potential with security issues. Of, note, I wrote an opinion piece in the Dec. 31, 2011 issue of the Washington Post on the value of the science. The security people do not understand the scientific enterprise, although I can understand their concerns. This whole thing has destroyed my Christmas Holidays. It still is not over. Divergent opinions in the scientific community ranging from 1) this work should never have been done in the first place (Ebright; Ian Lipkin) to 2) we should not restrict publication of any of the data and should just let it out (Racaniello; Peter Palese) to 3) we should publish only redacted version (which is ridiculous since the data are out already) to 4) we should destroy the virus (D.A. Henderson). Please note that the complexities of species adaptability to virus transmission and lethality is so complex that just because multiple induced mutations followed by passaging in ferrets of 1 strain of H5N1 does not mean that this virus would do the same in humans or that anyone else could replicate the experiment. Of great importance is the fact the Fouchier found out (but DID NOT submit it with his paper to Science - he wants to put it into a second paper)that if you take these 5 mutations and go back and put them into the wild-type H5N1, you do not get increased transmissibility, which proves my point (and that of Jeff Taubenberger) that transmissibility is a multi-genic process that is strongly "context-dependent". In other words, just knowing these 5 mutations may have little impact on someone's ability or not to repeat these experiments. Let me be clear, I believe that we need to now once and for all get the process going of a SOP for evaluating dual use research of concern (DURC) before the experiments are performed to evaluate the risk/benefit of even doing the experiments and to periodically look at the data to determine whether the data should be shared (presented or published) before one presents it or submits it to a journal. I think that there was major multifaceted failure here of NSABB covering their asses with the recommendation; researchers wanting attention for their work; failure of Amy Patterson's shop to get their job done over years; panic and hubris on the part of USG agencies who know nothing about science. I can go on and on. The problem that we are facing now is that we (USG) is being put in an untenable position of be involved in and associated with restricted (or as some say "censoring") scientific information when it is already out there. The process sets a bad precedent and it evokes all kinds of conspiracy theories and makes us look foolish. My choice at this point would be to admit that it is too late in the process - we should publish the unredacted papers and make this an "Asilomar moment" to make sure that we are not in this position again. Of note, on Jan. 7, 2012 a NY Times (written by Phil Boffey - unsigned - I know because he called me about it) came out with an inappropriately alarmist editorial entitled "Engineered Doomsday" calling into question the rationale for the research and asking for lock down of virus in BSL-4 and ultimate destruction of virus. He got most of his information from Ian Lipkin (my good friend) who feels strongly about this and was nice enough to tell me that he was going to do this. This editorial has only inflamed the hysteria and posturing.
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Jan. 15, 2012 - I still believe that there is no reason for the Journals insisting that the papers (redacted) need to be published by end of Jan/early Feb. Why not wait until this mess in openly discussed in an "Asilomar-like" setting.
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Jan. 16 - 21, 2012 - Major development pushed by my decision to be much more proactive in this process. Too many people were posturing and playing the "sound bite game" - Richard Ebright (who is a complete asshole), Mike Osterholm (with whom I am becoming progressively more disillusioned with due to his hysteria) and other well-meaning people who just like to comment, like D.A. Henderson. I never liked the fact that the journals (Science and Nature) were on a fast track to publish when we still did not know how we were going to develop a system to get the unredacted manuscripts only to "those who had a legitimate scientific need to know". We were getting significant pressure from the White House via HHS to make sure that there are no surprises with other such projects appearing. In addition, additional data were leaking out from Ron Fouchier's group having WH/HHS asking whether we should be shutting off their funding. I became concerned over the possibility that outside (non-scientific) influences would force us to set a bad precedent and stop funding these flu projects. Therefore, I took the bull by the horns and contacted Fouchier and strongly suggested that he and the flu scientists call a moratorium (60 days) on all work dealing with increased transmissibility and/or virulence of highly pathogenic H5N1 virus. At first, Fouchier was reluctant to do so since he felt that this would be an admission that what he did was dangerous and that he was backing down. He totally disagrees with the NSABB recommendations. In addition, I felt and told this to many in the press that we need to get more international involvement in this situation with WHO playing a major role. I felt that people were concerned that this was too much of a USA-centric situation and the USG was driving things that affect many others outside of USA. I agree. Therefore I agitated and accomplished that WHO (Keiji Fukuda) should hold a meeting in Geneva to add an international component to this situation. Importantly, on Wednesday, Feb. 18 I called Ron Fouchier in his home in Rotterdam (actually I e-mailed him and asked him to call me) at 4:30 PM DC time - 10:30 PM Rotterdam time. I strongly suggested that he call a moratorium on this work and encourage his flu colleagues to also do so. He was not totally convinced and said that he would consult with the others tomorrow (Feb. 19) AM and get back to me. I emphasized that it is likely if he does not do it voluntarily that forces beyond our control (i.e. the security people) would force us to defund the work. The next morning he called me and said that they had agreed to call a moratorium for 60 days and see what the Geneva meeting brings. Furthermore, Francis Collins and I called Bruce Alberts (Science) and Phil Campbell (Nature) and convinced them to delay the publication until at least March. Fouchier came out with a press statement on Feb 20 and Francis Collins and I came out with an NIH statement the same day applauding their decision. This was a good example of my having to take the bull by the horns since things were not going in the right direction. Now we wait to see what happens. There was wide coverage in the press about this "breakthrough" in negotiations with big stories in Washington Post, NY Times, Wall Street Journal, etc.