A single line often inverts meaning once you see what it
answers, so neighbouring messages are always shown.
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Dec. 20, 2004 to Jan. 14, 2005 - We have been occupied almost full time with doing damage control against the Dec. 13, 14, 15, 2004 AP articles by John Solomon. We have put on the NIAID Website a Q and A series that cogently addresses all of the allegations. This has apparently angered the reporter who is going after Cliff Lane and I now. Someone from the inside (Solomon said OGE, but I do not know whether I can believe him) "blew the whistle" on Cliff and I with the preposterous allegations that we are receiving hundreds of thousands of dollars from the IL-2 patent and that we are investing millions of dollars of NIAID money to support IL-2 research. Also, the whistle-blower told Solomon that I made Cliff Clinical Director as a quid pro quo for his putting me on the patent. Also, he queried whether my wife Christine gave the ethics approval of the ESPRIT IL-2 trial. This is nasty business. Cliff was made Deputy Clinical Director in 1986 and full Clinical Director in 1991. The patent was done in 1997. Chris has always recused herself from any actions on NIAID business. The Bayh-Dole Act requires that government employees file patents through the US Government on all inventions made during official government business. I originally did not want to be on the patent because I am NIAID Director. I was told by OGC and OTT that it was required since I was a clear inventor and to leave me off of the patent would make the entire patent subject to invalidity. I then queried of OGC as to whether royalties constituted a "financial interest" and thus subject to conflict of interest laws under 18 USC, Section 208a. I qually puts out ht found out that years ago the OGE ruled and the DoJ confirmed that royalties collected by government employees on patents owned by the government on which the employee is an inventor cannot be considered as a financial interest and so cannot be a conflict. The royalties are considered government compensation similar to performance awards and salaries. I was still uncomfortable about taking royalties because of my high visibility and so I told Mark Rohrbough (OTT for NIAID at the time) to have the government NOT send me the checks. He related that they were legally required to give me the check in order to fulfill the requirements of the Federal technology Transfer Act (FTTA). Thus, I have given every penny of my royalties to charity - The Foundation for NIH, Inc. Total royalties since 1997 = $45,072.82. Finally, I put the royalties on my financial disclosure statement (SF278), but OGE told me to take it off since it was equivalent to government salary that does not go on SF278. Nonetheless, Solomon wrote an article on the IL-2 story on Jan. 9 with the theme that Cliff and I should have let patients know about the "conflict" (even though there was no conflict). I believed that I saved the day by speaking with the reporter and explaining all of the above. It would have been better if my name was not associated with any COI story, but at least he mentioned about giving the money to charity as well as the fact that I tried to put the amount on my financial statement. The reporter has FOIA'ed our SF278s and so who knows what other smearing he might try to do with misinformation. Jan 15 - Feb. 3, 2005 - Story came out in AP about the IL-2 patent. The reporter (John Solomon) did indeed mention that I was required to file a patent and that I tried not to accept the checks and ultimately gave the money to charity. Also, he mentioned that I was told to take off the entry of the money on my SF278. In the end, it was not nice to have a story about me with a implication that I did something wrong, when in fact, I went out of my way to avoid conflict. The AP story led to CBS Evening News doing a story on the same thing on Feb.1. However, their angle was that I was the hero/Saint in trying to avoid conflict, and the NIH would not let me do the right thing. I came out looking good and the NIH looking foolish. In the end, it would have been better if the piece did not air. Fishbein issue: This abscess continues to fester. Fishbein continually puts out missives on his brother's Website (honestdoc.org) about "widespread misconduct and scientific fraud at NIH" and plays the role of defender of the public health. The Privacy Act (he is involved in a personnel matter) forbids us to respond. We are faced with the impossible situation of not being able to respond to this psychopathologic accusations. He can go public, but we cannot respond publicly. This is untenable. Influenza: Avian flu (H5N1) is still percolating in Asia (mostly Viet Nam and Thailand). Most recent cluster of cases in Viet Nam. We are continually having conference calls with the usual suspects on preparedness - Carol Kuntz, Julie Gerberding, me, Stewart Simonson, Lester Crawford, etc. Had a meeting in the West Wing of the WH on Feb. 2 with Claude Allan who has replaced Margaret Spellings as Assistant to the President for Domestic Policy. Present were Julie Gerberding, Stewart S., Allan Gilbert, Bruce Gelling, Amit (FDA), etc. We updated Claude who will brief President Bush. Feb. 3 - Mar. 8, 2005 - Another stress and crisis issue. A microbiologist named Ebright from Rutgers circulated an open letter(to Elias Zerhoun) among all the microbiologists stating that his analysis of study section data of non-biodefense grants over the past few years shows a decrease at the same time as the biodefense funding shows an increase. The letter was published in Science, first as an e-publication and then almost 2 weeks later (March 11) as a printed letter in Science. Problem is that the data that he pulled was via CRISP that is not designed to do comparative analysis of funding trends. The letter was signed by >700 microbiologists. The hidden agenda of Ebright and a very small group of signees (like Stanley Falkow) was that they feel that we should not be spending any money on biodefense research. They came to the conclusion in the letter that biodefense research was "hurting" non-biodfense infectious diseases research by diverting money away. They released the letter to the press without ever calling us or even sending the letter to us. This created a media storm and put us on the defensive to respond to what turns out to be entirely misrepresentative data. They took information from 4 out of 30 study sections that really misrepresent the big picture. The study sections involved mostly reflect activity in NIGMS that may be funding fewer "model organism" grants for reasons that have nothing to do with biodefense funding. I was furious! Clearly some few individuals were pushing their anti-biodefense agenda and the rest of the microbiology community was following like sheep. When several were asked about this after the media storm, they were embarrassed (such as Barry Bloom) and said that they really did not think that this was what they were signing on to. Many newspaper articles appeared and I led the rebuttal in the newspapers, NPR, and several speeches. EZ and I will write a letter in response to Science. Clearly when you examine the data correctly, non-biodefense has done as well or better at NIAID as the rest of NIH, i.e. when you compare the percent increases from year to year from 2001 to 2006. Also, much of biodefense money is also spilling over to non-biodefense or "dual-use" projects such as innate immunity, influenza, SARS, diarhheal diseases, etc. Clearly, the Ebright letter is misleading. Problem is that since all money is now tight, people are acting as expected, i.e. they want to blame someone or something for their personal and specific issues. Now they are blaming biodefense resources with a sub-text of anti-Bush Adminstration and anti-Iraq war. It is really ridiculous how they distort and I am in the middle of the fray. However, this is one that I will not back down on. On March 7, I met in my office with Michael Gerson, former top speech-writer for President Bush and now senior advisor and Assistant to the POTUS. Mike wanted to discuss ideas for addressing neglected or other diseases as an initiative for the POTUS to put before the G-8 summit. This is very similar to last year's activities (see above). I will work with him on a malaria intiative (see last year) and a TB in HIV disease initiative. Apparently Gary Edson and Josh Bolton sent him my way. I will be submitting the malaria and TB proposals for the POTUS consideration. March 8 - March 27, 2005 - Continued concern about the H5N1 bird flu in Viet Nam, Thailand, and Cambodia. Most severe now in Viet Nam. Working closely with Stewart Simonson, Julie Gerberding and the DHHS on Pandemic Influenza Preparedness. Mar. 27 - April 1 - Phenomenal vacation with Chris and the girls for Spring Break in Costa Rica. First vacation that I have had unassociated with a lecture or other business in 20 years since our honeymoon. Went for 2 1⁄2 days at Papaguyo Beach and 2 days in rain forest and Arenal Volcano. Did zip wire rides over the canopies. One of the most exciting things that I have done.
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April 4, 2005 - Amazing day at White House today. Briefed the President on AIDS (domestic and International). Reason for briefing was preparation by the WH for the reauthorization of the Ryan White AIDS Care Act originally passed in 1990. The POTUS wanted to make sure that we were not short-changing domestic AIDS in light of all of the money (PEPFAR) that we have recently been putting into international. Briefing from 9:20 AM to 10:05 AM. The POTUS walked into room and immediately greeted me and although the briefing was supposed to be predominantly on Ryan White, he asked me many questions for about 20 minutes. It was a 2-way conversation between him and me. At the meeting also were VP Cheney, Scooter Libby, Andy Card, Karl Rove, Dan Bartlett, Scott McClellan, Josh Bolten, Kristen Silverberg, Secretary Leavitt, Claude Allen, Joe O'Neill, Philo Hall, Tevi Troy. Wonderful interaction between me and POTUS...great day Also, today I went to and presented a major lecture at the IOM Pandemic Influenza meeting in honor of John La Montagne. After that I got briefed by the IOM committee reviewing the HIVNET012 trial (see Fishbein above). They totally agreed with us and said the trial was effective, ethical, and safe. Went back to WH to brief Claude Allen on Influenza together with Stewart Simonson, Julie Gerberding, Philo Hall, Dean Casey, Tevi troy, Kristen Silverberg. This was in preparation of Secretary Leavitt and I briefing the POTUS on Wednesday , April 6. However, the POTUS meeting will be postponed until next week since the POTUS will go to Rome for the Funeral of Pope John Paul II.
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April 4 - 27, 2005 - More of the same with Fishbein situation. IOM panel report came out very clearly supporting all that NIAID and we had been saying about HIVNET-012. In typical fashion, John Solomon of AP and Sen Grassley (who parrots everything that AP says) are claiming that the IOM panel report is invalid since some members of the panel receive NIH grants and so are conflicted. The Fishbein/Grassley/AP axis is clearly one of the most unethical and disgraceful situations that I have ever experienced. They all have no integrity and absolutely no regard for the truth. We are now working on a possible settlement with Fishbein to make this craziness go away. He may well ask for totally undeliverable conditions. The DHHS is still reluctant to allow us to fire Fishbein because they are afraid of Grassley.
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April 27, 2005 - Briefed the President about the potential for an H5N1 pandemic influenza. At briefing were the POTUS, the VP, Karl Rove, Josh Bolten, Kristen Silverberg, Dan Bartlett, Scott McClellan, Fran Townsend, Michel Gerson, Claude Allen, Julie Gerberding, Sec. Leavitt, Scooter Libby, Philo Hall, Rajeev, etc. The POTUS was very pleased with the briefing and asked the right questions. He was favorably disposed to our suggestion of considering having the USA public have kits of antimicrobials (Tamiflu, CIPRO, etc) in their homes in case of an emergency in order to get around the problem of distribution of drug to tens of millions of people in an emergency. We are going to pursue this approach with Symposia to get the flavor of what the community thinks of it and then we will pursue it.
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2005-05-12 00:00
Anthony S. Fauci
May 12, 2005 - Met today in Building 31, 7A-24 with the Ugandan Vice president Professor Gilbert Bukenya, who is former Dean at Makerere University in Kampala. We had met previously when he was still in academics and now he is VP. We discussed collaborations between Uganda and NIAID. Over the past couple of weeks we are still engaged in trying to settle the Fishbein issue. He continues to attack. Cliff Lane is leading the arbitration effort for a settlement. It is clear that he, his brother Rand, his mother and their lawyer Steve Kohn are bad people, well beyond the lawyer issue; they really suck without care for lives of people whom their lying endangers. Also, morale at NIH is the lowest that I have ever seen it. House Chairman Joe Barton is trying to "reauthorize the NIH" by consolidating ICs and putting much more money into the NIH Director's office. We cannot tell if Barton is doing this on his own or if Zerhouni is behind it. I tend to think that it is a bit of both, but that Barton is the main driver. Also, the conflict-of-interest issues have not been settled.
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May 23 - 27, 2005 - Things again heating up with avian flu in Vietnam with press reports that the virus in evolving with possible resistance to Tamiflu and greater number of clusters in Vietnam. Lesser virulence could mean that virus is adapting to humans better. It is likely that all of this just reflects better surveillance and reporting as opposed to a significant degree of evolution of the virus. Nonetheless, the press has jumped on this and I have been on CNN a few times, Jim Lehrer Newshour, Lou Dobbs (CNN) and CSPAN for a Congressional Hearing on Flu (Energy and Commerce with Chairman Deal). Also, several briefings at DHHS and the White House with the usual suspects. May 30 - June 3, 2005 - Bird flu activities continue with briefing at DHHS a couple of times. White House briefing on June 2 on purchases of Tamiflu versus vaccine in VP's ceremonial office in White House. Present were: Carol Kuntz, Binita Ashar (Carol's assistant, Tom Reilly (OMB), Norris Cochran, Jeremy Katz, Rajeev Venkkaya, Lance Leggitt, Stew Simonson, Bill Raub, Kerry Weems, Bruce Gellin, Laura Lawlor (by phone), Jesse Goodman, CDC by phone - Julie Gerberding, Charles Schable, Steve Bice, David Baden. We are trying to reconcile the budget projects for FY 05 and 06 and 07 with the purchase needs for stockpiles of H5N1 vaccine and tamiflu. My role was important since we are doing the clinical trials with the H5N1 to determine the correct dose. This will then determine whether we will buy and how much depending on the required dose. We already have 2 million doses of vaccine in bulk and we plan to buy 20 million more vaccine doses. Also we are thinking of 20 million more treatment doses of tamiflu. Also, White House briefing with Carol Kuntz on June 3 on biologics biodefense.
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May 24, 2005 - Have had continual trickling in of cases of human infections with H5N1 with most recent count of 218 cases and 124 deaths. Fifty countries now have birds infected and 10 have birds and humans infected. Of note that about 1-2 weeks ago it became apparent that there was a family cluster of 7 cases in Sumatra, Indonesia. Recent evidence strongly indicates that this was human-to-human spread similar to the small cluster in Thailand in 2004 where 11 year old girl infected her mother and aunt who nursed her in the hospital before she died. Similar situation in Sumatra where father nursed 10 year son and others in family slept in small room while one or 2 people were coughing all night. Bottom line was a media blitz. I was asked by HHS and White House to go to "Pebble Beach" on the White House grounds and do wall-to-wall interviews to allay fears. Fact is that the cluster looks like it is dead-ending. I did interviews with NBC Evening News, CBS Evening News ABC World News tonight, Nightline, CNN Wolf Blitzer Situation Room, WTOP radio, MSNBC TV, etc. Big time exposure. HHS was very pleased with how I handled this volatile situation.
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June 3 - 14, 2005 - I have not been recording events since I have been very busy, but over the past 10 days or so there has been considerable activity around the area of pandemic flu, biodefense, etc. I have briefed DHHS people as well as WH people. In addition, on June 13 we had a Hearing of the House Government Reform Committee for Biodefense chaired by Rep. Christopher Shays. I testified along with Stewart Simonson, Dale Klein (DoD), Joe Vitko (DHS), and Ron Saldareni (formerly of American Cyanamide and nowon an IOM Committee of Biodefense). The Hearing was mostly blasting DoD for disorganization and "wasting money". Also, I went on my yearly trip to review the Gaslini Institute for Lorenzo Moretta from June 8 - 10. We are in the final stages of finally officially firing Jonathan Fishbein. The issue is that Sen Grassley and his Committee will likely come after us for this since they always take the side of whistleblowers, even though Fishbein is not really a whistleblower as he blew the whistle after he was told that he would be fired for performance. June 14 - July 2, 2005 - Many activities around briefings of White House, DHHS and Congressional Hearing continue. Had 2 more Hearings within said period: 1) Senate Foreign Relations on HIV Vaccines with actress Ashley Judd; 2) Hearing of House Government Reform Committee on Influenza Pandemic Threat. I testified with Jim LeDuc (CDC) and Bruce Gellin (HHS). Have been on CNN and all over C-SPAN. We finally fired Jonathan Fishbein (on July 1) amid angry threats from Sen. Grassley's staff. I must include in my book how totally vicious and completely unethical that crew is. They are a disgrace to government. They totally distort the Fishbein story and attack the NIH and everyone else, all in the name of protecting "whistleblowers" even though he is not a whisteblower.
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July 14, 2005 - Lots of stuff going on. Had more Congressional Hearings. Today had Hearing on success or failure of Project BioShield. Testified before House Government Reform Committee chaired by Tom Davis (R-VA) and Henry Waxman as Minority. Also, Chris Shays there and Congressman Issa, Davis, Issa, Cummings. I testified with Stewart Simonson, and Joe Vitko (DHS). Interesting issues around current BioShield (BS) legislation. The original Bill for BS was strong and contained indefinite authority to purchase for stockpile as well as other strong incentives for industry. Remember when I went around to the House and Senate at the behest of the VP to push BS, several Senators and Members, particularly Sen. Byrd tried to neuter the Bill since they did not want to give big Pharma too much. Now we have a Hearing where the Congress is chiding us since we have not gotten enough products through BioShield. The reason is that the big companies do not see any major advantage since they have no liability protection, no tax incentives and no patent advantages, and not a big pot of money. This is an amazing irony. Went to White House for a regularly scheduled (have not been reporting on these) PCC on Pandemic Flu Preparedness. Co-Chaired by Rajeev Venkayya (HSC) and Lance Leggitt (DPC). Reps were there from every cabinet department, CIA, etc. I presented that we actually had a vaccine sine the results of the dosing shows a clear dose-response curve for the prime-boost. We tested 7.5, 15, 45, and 90 ugm and clearly 90 gave a good protective response after 1 dose and an amazing response after 2 doses. Now we have to figure out the right dose sparing (adjuvant) strategy and/or the right combination of prime/boost. On the way out of the WH, ran into Bob Woodward. Of note, I had just read his new book "Secret Man" about Deep Throat Mark Felt. I congratulated Bob on the book and discussed it a bit. Reauthorization language for the NIH has been circulating for comment. It is incredible. It give all of the power to the NIH Director by eliminating individual appropriations and by creating an IC within the NIH to "carry out" research. Importantly and I must put this in the book. Chairman Barton has threatened to a group of constituency groups who had come to him objecting about the bill that if any NIH IC Director publicly opposes the Bill, he will open an investigation of that IC until the person begs for the legislation. This is after they had "asked for comments". This is a clear case of blackmail and in my mind is unethical, and possibly illegal. I was told this over the phone by his Committee Staffer Cheryl Jaeger.