Diary Prequel Package — page 113

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. 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