FAUCI DIARY ARCHIVE — Monday, December 20, 2004 https://faucisdiary.com/diary/2004-12-20 Text below is verbatim from the released PDFs, with the original line breaks. ============================================================================== DIARY ENTRY — Monday, December 20, 2004 Source: Diary Prequel, pp. 112–113 of 2026.07.27_Diary-Prequel-.pdf Words: 553 ------------------------------------------------------------------------------ Terrible time over the past couple of weeks with a 4 part story by an AP reporter on the Jonathan Fishbein issue and the HIVNET 012 story. Fishbein is a Title 42 on a 2 year probation period in DAIDS. His performance was terrible and Ed Tramont and Jon Kagan decided to remove him. He got a high-priced whistleblower lawyer and claimed whistleblower status despite the fact that he “blew the whistle” AFTER he was informed that he would be removed. He leaked internal documents regarding the technical difficulties with HIVNET 012 (use of nevirapine for prevention of mother-to- child transmission (MTCT) of HIV. In that landmark trial it was shown that the drug in a single dose was safe and effective for prevention of MTCT. The use in these circumstances has likely saved tens of thousands of children’s lives in developing countries, particularly sub-Saharan Africa. The paper appeared in Lancet in 1999 and several papers have corroborated the safety and efficacy of Nev. For MTCT prevention. Since the results of the trial (HIVNET 012) were so striking, the maker of Nev (BI) decided to use the data from the trial to expand the licensed indication of Nev to MTCT in the USA. Upon inspection of the site and the data collection procedure, the FDA and an auditor ruled that there were “technical” problems that would not allow licensure. Ed Tramont decided to have a more comprehensive look at the “technical” difficulties and ultimately found that the procedure was sloppy (not surprising for an inexperienced African site); however, the data were sound, i.e. Nev is still safe and effective. A low level person in DAIDS wrote a safety report that exaggerated (in Ed Tramont’s mind) the negatives and indicted the entire trial. Ed used the report from the more comprehensive audit and changed the lower level report to indicate that there were technical difficulties, but this does not change the results of the trial. Fishbein in his attempt to not get fired for incompetence (totally unrelated and anteceding the issue of HIVNET 012) went to the Congress (Sen. Grassley – who never met a whistleblower that he did not love) and finally the AP. The AP story was incredibly misleading in that it published Fishbein’s “whistleblower” claims of widespread misconduct in DAIDS, our (mine and others) failure to notify the president about the problems with HIVNET 012 before he launched the $500 million MTCT program, and a variety of other charges. This raised a lot a stink with and ABC Nightly News show. Surprisingly, the regular media did not take it up much, but it was all over the internet circuit. I worked hard to keep it off CNN, NBC, Washington Post, NY Times by pre-emptively discussing the truth with the reporters. We are “hand-cuffed” in what we can say since the Fishbein issue is a personnel matter and the Privacy Act is involved, Also, the Whistleblower statute (even though Fishbein is technically not a whistleblower since he blew after he was fired). Interesting how the laws protect the scoundrels. Our major concern is that this publicity will cause the uninformed to stop using Nev for MTCT. Of note, Rev. Jesse Jackson published his typical demagogue-like letter condemning President Bush, accusing Ed Tramont of “crimes against humanity”, etc. Will give more follow-up soon. DIARY ENTRY — Monday, December 20, 2004 Source: Diary Prequel, pp. 113–116 of 2026.07.27_Diary-Prequel-.pdf Words: 1584 ------------------------------------------------------------------------------ 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 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 ½ 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.