Read Tony's Diary: The Prequel (Part 2 of 8)

hung up and
Released by Chairman Rand Paul
63mentioned this to Kristen Silverberg.  She knew nothing and immediately called Dan
Bartlett (WH Press Office).  I did not hear what they said; however, apparently what
happened is that the press confronted the WH with the Walters interview and the WH
caved in and admitted to the policy.  The crazy thing is that it has now hit the press, but
the WH will not let us talk about it since the President has not officially announced it.
We still do not really know what the policy will be nor when it will be announced.  More
later!
Dec.12, 2002 – Much activity back and forth with the White House and the DHHS
regarding putting the finishing touches on the President’s Statement and the policy in
general.  In particular, Kristen Silverberg and checked frequently with me.  In mid-
afternoon she called me down to the White House with Stewart Simonson to go over
word-for-word the President’s statement.  We were the only DHHS people asked to do
this.  Big surprise in the statement was the fact that we will make vaccine available to the
public before 2004 by allowing people who insist on vaccination to enter into an ongoing
clinical trial (Cangene, Acambis, etc.) or by creating a special IND protocol  (using
Aventis-Pasteur).  Exciting few hours at the White House with Karl Rove, Andy Card,
Josh Bolten, Mike Gerson (President’s speechwriter), Kristen, Susan Neeley (Public
Affairs for Homeland Security), Dan Bartlett (Deputy to Ari Fleischer)Stewart and I
having lively back and forth conversation.  I insisted that they emphatically emphasize
that we do not recommend vaccine to the general public; however, we will make it
available to those who feel they still want it even though it is not recommended.  I
consider this a great victory since I am concerned about tens of millions of people getting
vaccinating, which will surely lead to some serious adverse events.
After the WH, Stewart and I went to the Department and worked on Qs and As
for hours until around midnight.  Also, we briefed the Governors of the States and the
State Health Officials by teleconference.
Dec.13, 2002 – Day of the announcement by the President.  The DHHS team including
me went to the WH at 1:00 PM in preparation for the 2:15 PM announcement.  We met in
the Roosevelt room and discussed the policy with Ari Fleischer, Dan Bartlett, and others.
Bill Winkenwerder represented the DoD.  Big surprise was that we learned the President
would get the vaccine himself since he felt that as Commander-in-Chief of the Armed
Forces, he could not order the troops to do something that he himself would not do.  He
will say that Laura and his children will not be vaccinated since they are part of the
general public.
President makes announcement.  On stage with him was me, Tommy Thompson,
Gov. Ridge, Julie Gerberding, Bill Winkenwerder, someone from State Dept.
Afterwards, the President left and we all gave brief remarks and answered questions.  The
rollout went extremely well.  I was on CNN and Julie and I were on the Jim Lehrer
NewsHours together.  I had been scheduled by Ari Fleischer to go on all of the Sunday
talk shows with Tommy Thompson on Dec. 15; however, we were bumped by the
breaking news of Trent Lott facing forced resignation because of his “segregationist”
comments at the birthday party of Strom Thurmond.  Nonetheless, I got my picture in
both the NY Times and The Washington post standing next to the President and TGT.
Released by Chairman Rand Paul
64Also, over next few days I appeared on CNBC, WTOP radio and NPR – “Talk of the
Nation”
Dec. 18, 2002 – Another exciting day at the White House.  Clearly, Scooter Libby and
the VP are in favor of pushing for the Vaccine Trust Fund.  OMB and the WH economic
advisors have a problem with the concept of a trust fund.  As usual, Carol Kuntz has been
very supportive.  Was called down to a meeting at the WH with OMB people (Jim
Capretta), the VP staff (Carol K., Seth Carus, Noreen Hynes), DHS people (Richard
Falkenrath, et al), Kristen Silverberg, Ken Bernard, Stew Simonson, Phil Russell, Bill
Raub.  We had to discuss the vaccine research plan.  Again, must concern as to why we
need a trust fund instead of an appropriation.  I explained that one (the fund) is
mandatory and the other (appropriation) is discretionary.  Jim Capretta came up with the
idea of a “Permanent and Definite Appropriation” that would be mandatory and multi-
year.  In the middle of the meeting, Scooter Libby called me on my cell phone and said
that he was going into a meeting with the VP and the President at 1:00 PM (it was now
11:30 AM) and he needed for me to write a ½ pager on the concept of a mandatory fund
for vaccine (he said trust fund, but we subsequently hashed out a Perm. And Def. Appr.
He also wanted a microbe by microbe breakdown with time-lines and costs – all by 12:55
PM. In addition, he wanted me to meet with the CEOs of “Big Pharma” to determine if
they would support this.  I rushed to the DHHS with Stew, Kerry Weems, Phil Russell
and Bill Raub and put together a great package to e-mail and FAX to the VP’s office
(Carol K.) arriving a few minutes before 1:00 PM.  They loved it.  We will wait to see
what happens.
Dec. 19-22, 2002 – Still much activity with the VP continuing to push to help us get a
Permanent and Definite Appropriation for purchase of countermeasures, particularly, but
not exclusively for vaccines.  There is much concern about botulism and acquiring
botulism anti-toxin.  Many phone calls and meeting with Stewart Simonson with whom I
now speak with and/or meet at least several times per day.  Carol Kuntz and Noreen
Hynes are trying to help us.  They asked us to put together a programatic assessment of
our procurement needs for countermeasures without consideration of budget constraints.
We had previously put together a $4.2 billion package concentrated mostly on MVA and
rPA (anthrax) with only about $450 million over 10 years for other countermeasures.  We
presented this several days ago to OMB people in the presence of Kristen Silverberg (see
above).  OMB was miffed that they had not seen these numbers before, when in fact the
numbers were contained in our budget submission for ’04, but were not specifically
designated as purchase.  Clearly OMB is resisting the VP’s attempts to get this fund
through.  The new “no budget constraint” package that we put together was
approximately $15.0 billion over 3 years (FY04 – 06) with considerable amount now to
other countermeasures such as botulism, plague, Ebola, tularemia, Rift Valley Fever,
EEE/VEE/WEE, Staph. Enterotoxin, antibiotic resistance, pandemic flu, WNV, etc.
Even though this was put together by Phil Russell with help from DMID, the VP wants
me to defend it to OMB since they are cashing in on my reputation and scientific
credibility.  The VP has set up a meeting for Dec. 23 at the WH with himself and Scooter
Libby teleconferenced from Jackson Hole and me, Mitch Daniels, Nancy Dorm (OMB
Deputy Director), Tommy Thompson, the VP’s staff, etc. (see below).
Released by Chairman Rand Paul
65Dec. 23, 2002 – Critical meeting at the White House (see above).  Attending were VP
Cheney and Scooter Libby by teleconference from Jackson Hole; Stewart Simonson, Phil
Russell, Kerry Weems (Budget, DHHS), Carol Kuntz, Noreen Hynes, Seth Carus, Nancy
Dorm (Deputy Director OMB), Tom Reilly and Jim Capretta (OMB).  Issue was that
Scooter and the VP had asked Carol Kuntz a couple of days ago to put together a threat
related proposal for a wide range of microbes with no concern for budget to be used for
procurement of products.  It should be program and need driven.  Carol tasked me to do
this with Phil Russell.  I worked until late through the night of Dec. 22 fine-tuning this
and learning it cold.  The proposal went beyond MVA, rPA, and included botulism,
plague, tularemia, Ebola and other hemorrhagic fevers, pandemic flu, West Nile. Etc.
The proposal came to $15 billion from FY’04 – ’06.  The OMB had agreed several days
ago to creating a “Permanent and Indefinite (first it was definite) appropriations authority
to purchase vaccines for BioT for a total of $4.2 billion.  In typical OMB fashion, they
were against any new spending.  The intense interest of the VP was the reason why we
were being listened to.  Importantly, Carol Kuntz called OMB people to the meeting
(Mitch Daniels was supposed to be there, but he was out of town) but did not warn them
that they would be faced with a $15 billion exercise in front of the VP.  I convinced Carol
to let them know at least a few minutes before the meeting started.  They were mortified
and enraged that they were not warned in advance.  As Nancy Dorm said, every time she
sees me, it costs her billions of dollars.  The VP called upon me to present the proposal.
Nancy did not get it.  She was tied down in process.  She insisted that the original
agreement was for vaccines only and not what she called “countermeasures” such as
botulism antitoxin and Cidofovir, which were on the list.  She did not understand that
“Countermeasures” is the big umbrella under which are vaccines, antitoxins, etc. Also,
she argued that we she not include in the purchasing authority anything that was not
licensed.  I proposed that we should include anything that was “licensable”, i.e. on the
way to license by the FDA, but perhaps months away because of the FDA process.  The
VP very clearly was on my side and did not hide it.  He even said to Nancy “ Do you
expect me to go to the President and the American people and say that we cannot provide
countermeasures against threats that we either know or strongly suspect that Iraq has
because we do not want to broaden authorities and because the “process” will not allow
it?”  She then said that she would work with us to get something out.  The VP was
spectacular!  It was a  classic example of OMB not being able to get beyond process and
missing the entire point of the concept.  Amazingly, Nancy said that “look what happened
with the smallpox vaccine.  We bought it and now we are not even going to use it
widely”.  She considers the smallpox vaccine situation, which was one of the great
successes of the year to be a failure since many Americans would opt not to take it.  She
does not understand that the fact that we have it is critical.  Amazing!
The meeting ended with the VP clearly in my corner.  My relationship with him,
Scooter and the whole staff, particularly Carol is getting very strong.
Dec. 24, 2002 – Nice surprise today.  At 1:00 PM, I received a call in my office.  I
answered the phone since everyone else had left for the ½ day Christmas eve.  On the
other end someone sang the full verse of “Happy Birthday”.  It was Secretary Thompson
calling from Wisconsin on a cell phone from a shopping center.
Released by Chairman Rand Paul
67discussed the need to establish a BAT team or biological anti-terrorist team to be
available to the President for advice and service in the event of a catastrophic attack.
Present was among many others: Julie Gerberding, David Franz, Lisa Gordon-Hagerty,
Josh Lederberg, Richard Danzig, Bill Patrick.  Entire attendee list is in my files.
Jan. 13 or 14, 2003 – Meeting in the West Wing (Ward Room) of the White House with
Kristen Silverberg, Ken Bernard, Carol Kuntz, Amy Jensen, Sally Canfield (DHS), Jim
Capretta, Tom Reilly, Richard Falkenrath, Stewart Simonson and others from WH
communications to continue to fashion the precise language of the Project Bioshield
(authorities, Procurement, FDA regs) in preparation for getting this into the President’s
State of the Union (SOTU) address .  We wrangled a bit about the precise language.  We
will meet again in 2 days to finalize it.
Jan. 17, 2003 – Another meeting at the White House in Andy Card’s office (he was not
there).  Met with all of the above (Jan. 13/14) plus Patrick Aylward and minus Amy
Jensen, Jim Capretta, and Richard Falkenrath to continue discussion.  We went over
comments regarding draft legislation and discussed the role-out for the SOTU address.
Also, the WH has decided that soon after the address (around Feb. 3) the President will
role out Project Bioshield more formally at an event likely at DHHS or at NIH.  I will be
there and then will be called upon to do a lot of briefings of the Press and Congress.
Jan. 22, 2003 – Just heard from Ken Bernard at the WH that the President has decided to
include Project Bioshield in the SOTU address.  Also, he plans to visit the NIH on Feb. 3
to roll out the plan.
Jan. 23, 2003 – Another important meeting in the White House with the same people as
on Jan. 17 plus Amy Jensen, Ginger Loper.  Putting the final touches on the 3 Bills (a)
Permanent and indefinite authority, b) Special FDA authorization of products in
emergency, and c) my special authorities.  Also, discussed plans for President’s visit to
NIH.  After the meeting, went to see Josh Bolten to get a feel for what the President
would like to do during his visit.  Josh invited Kristen Silverberg and I into his office to
meet and talk with Mr. Sandy…… (Ambassador to China) and Bo Derek.  We discussed
AIDS in China and then Josh and I went out of the room and talked about what the Pres.
Might want to do.  Apparently he likes to observe technical things, but does not like to
“sit down and be a prop”.  Went back to EEOB to a going away party for Seth Carus and
Noreen Hynes.
It appears that Elias Zerhouni is getting uneasy and insecure about my dealings in
Biot, particularly with the WH connection.  When I dutifully told him today that the Pres
was coming to NIH, he said that he really needed to become more visible in the arena of
Biodefense.
Jan. 24, 2003 – More activity back and forth with Gary Edson, Jay Lefkowitz and me on
the AIDS issue.  It is still alive.  They now want me to bring back Peter Mugyenyi from
Uganda to meet with Mitch Daniels (and me).
Released by Chairman Rand Paul
68Jan. 26, 2003 – Peter M. arrives from Uganda and Mark Dybul and I prep him for the
White House visit.  We have late lunch-early dinner at Mark;s house to brief Peter.
SuperBowl Sunday.
Jan 27, 2003 – We (Peter and I) meet with Mitch Daniels.  Mitch seems genuinely
moved by Peter’s description of AIDS in Africa and is very deferential to Peter and me.
Gary and Jay ask that I plan to spend the entire day at the White House on Tuesday, the
day of the State of the Union Address.  Something is up, not sure.  They even suggest that
Peter might join a group of VIPs in a satellite site (i.e. White House or EEOB) to watch
the SOTU address.
Jan. 28, 2003 – One of the most amazing and important days of my life!  Spent the entire
day (11 hours) at the White House. I arrive at the White House and Gary Edson and Jay
Lefkowitz inform me that the President has decided to adopt our AIDS Implementation
plan – the full version!!!  $15 billion over 5 years starting with $2 billion in FY2004.  $10
billion will be entirely new money including $1 billion to the Global Fund for HIV/AIDS
Tuberculosis and Malaria.  Peter Mugyenyi will sit next to Laura Bush in her box at the
Capitol for the speech.  I spend the whole day at the WH proofing the SOTU, fact
checking, preparing and proofing Qs and As with Jay and Gary.  The WH personnel are
all congratulating me for pulling this off.  Josh Bolten told me that I am his hero; Karl
Rove and Andy Card are generously congratulatory towards me.  Gary, Jay, Kristen,
Josh, et al ask me to stay at the WH to have pizza with them and watch the SOTU
address. I had to leave at 7:00 PM to prepare for my Senate Hearing on Smallpox the next
day.  The SOTU was fabulous.  He rolled out BOTH Project BioShield and the AIDS
initiative – 2 things conceived of and planned by me (with obvious help from many,
particularly with BioShield).  This has truly been an historic day!
Jan. 29, 2003 – Testified to the Senate Appropriations Subcommittee Hearing chaired by
Arlen Specter. Also present were Sens. Harkin and Murray Hearing on Smallpox
vaccination plan.  Julie Gerberding and I testified.  Concern on the part of local health
officials and hospital people that the USG plan does not provide for compensation to
people injured by receiving the vaccine. Hearing went quite well. Spent the rest of the
day at the WH doing post SOTU briefings and handling press calls.  I used Jay
Lefkowitz’s office.  We sent off Peter back to Uganda.  At the end of the day, I briefed
Ari Fleischer for 1 hour on Project Bioshield.
Jan. 30, 2003 – Testified at the Senate HELP (Health Education Labor and Pensions)
Subcommittee Hearing with Julie Gerberding again on the subject of smallpox vaccine
plan.  Issue of compensation came up again.  At the Hearing was Sens. Judd Gregg, Bill
Frist, Alan Reed, Barbara Mikulski, Hiliary Clinton.  Hearing went well.  Spent rest of
day at the Department are downtown doing Congressional Briefing to HELP committee
on Project BioShield and to Secr. Thompson on Smallpox.  Did the CNN Wolf Blitzer
show with Secr. Thompson, Julie G., Mark McClellan (FDA) and Jerry Hauer on the
subject of the HHS Biodefense Command Center.
Released by Chairman Rand Paul
69Jan. 31, 2003 – Spent most of day at DHHS and the WH.  President gave absolutely
wonderful speech at the WH to the PACHA (Presidential Advisory Committee of
HIV/AIDS) and the African Ambassadors.  He truly reflected his commitment and
passion concerning our moral obligation to do something about HIV/AIDS
internationally.  He mentioned me specifically.  Interesting that the activists who were
completely trumped by the POTUS announcement, now can only complain that only $1
billion of the $10 million new money is going to the Global Fund.
Feb. 1-2, 2003 – Much preparation for the President’s visit to NIH and for the briefing of
the President on Feb. 3 on BioShield.  Many calls from WH I am asked by WH people to
fact check things that he will say.  Also, they want me to be responsible for arranging the
details of his visit to the Vaccine Research Center.  His advance people keep calling me
and Kristen and others keep asking if everything is going OK.
Feb. 3, 2003 – Another magical day!  In the AM, I brief the POTUS on Project
BioShield.  Place = Roosevelt Room of the WW.  Present are POTUS, VP Cheney, Tom
Ridge, Tommy Thompson, Scooter Libby, Condi Rice, Karl Rove, Josh Bolten, Kristen
Silverberg, Adm Abbott, Ari Fleischer, Dan Bartlett, Ken Bernard, Elias Zerhouni, Carol
Kuntz, etc.  I played major role in walking him through the Project.
We rush back to NIH to greet him (Flying in on Marine One) at the VRC.  We
give him a tour and he is smash hit with the staff.  We go over in motorcade to Natcher
Building where he gives major address.  He specifically mentions me as an old friend and
someone who he thanks on the part of the country because I have been for many years
THE general in war on AIDS.   His speech drew applause every time he would mention
me, Zerhouni,  or AIDS in Africa Plan, but no applause when he spoke of the likely need
to go to war with Iraq. He leaves and I spend rest of day and also Feb. 4 doing press calls
to describe in detail Project BioShield.
Feb. 4, 2003 – The world knows that the President’s Plan came from me and I am
briefing many people.  The WH refers all questions about Project BioShield and The
President’s AIDS Plan to me  Got a call from Richard Feachem, President of the Global
Fund for AIDS, Tuberculosis, and Malaria, congratulating me on the Plan, but expressing
concern that since the USA only put $1 billion new money in the Fund over 5 years that
now the other countries would be reluctant to contribute more to the fund than the USA.
I told him emphatically, but in a nice way,  that I disagreed.  The original purpose of the
Global Fund was not to replace bilateral agreements, but to complement them.  Feachem
is essentially saying that the other $9 billion in new money does not really count in a
matching game since we did not put this in the Global Fund.  Unbelievable.  I have now
told people.  This is not about the Fund or about your particular choice of  how you give
money.  It is about saying the lives of people in Africa and the Caribbean.
Another looming problem is the Mexico City Agreement which states that
Foreign NGO who counsels on abortions or who supports the performance (with funds)
of abortions is not eligible for USG funding.  This might make the implementation of the
Plan through NGOs difficult.  Also, I need to check with the US Trade Representative
about the generics and breaking patents.
Released by Chairman Rand Paul
70Feb. 6, 2003 – Snow storm in DC.  Went out to dinner with Stew Simonson and driving
back home from Etrusco’s restaurant on DuPont Circle I hit a patch of ice on Cathedral
Ave., spun around twice and broad sided a telephone pole. No other cars or people
involved.  I was unhurt and drove my wrecked car home.  Luckily it still ran since only
the side doors (passenger side) were destroyed.
Feb. 6 – 12, 2003 – Much briefing of White House and Congressional staff on Project
BioShield and the President’s AIDS plan.  Much, much activity.  The WH wants me in
on all briefings.
Feb. 13, 2003 – Delivered Plenary lecture at the 10th Conference on Retroviruses and OIs
in Boston.  Spoke on Role of viremia in host abnormalities.  Very well received; it was
hard core basic science, which was in sharp contrast to the publicity that I have been
getting for the policy issues.
Returned in early afternoon to go to WH to brief Congressional leaders on Project
BioShield.  Received secret briefing from CIA Torrey Froscher (Deputy Director,
WINPAC, CIA).  Present were Admr Stephen Abbott, Tom Ridge, Tommy Thompson,
Jim Capretta, Kristen Silverberg, Chris Cox  and Ginger Poers (Special Assistants to the
president for Leg Affairs), Sens Gregg, Congressmen Burr, Turner Cox, Tauzin, Sen
Collins; Sally Stansfield, Stewart Simonson, Carol Kuntz.  The President walked in
during the meeting and greeted the Congressmen and gave me a special warm greeting
saying that the “A” team was there.  He now has his special name for me.  It is not Tony
or Dr. Fauci it is “Fauci”.
Feb. 13, 2003 – Received wonderful FAX from Bono congratulating me on the AIDS
initiative.  Referred to us as “partners in crime”.  Did more briefings on the hill as well as
briefing of activists Paul Davis, Asia Russell, Rachel Cohen (MSF) on the Pres. initiative.
Still much concern out there that we did not put all of the money in the Global Fund.
Yet, the Global Fund has not really done anything yet.
Also, issues such as generic drug purchase and the Mexico City Agreement
(MCA) have come up.  Importantly, Jay Lefkowitz is supporting my view that even if
organizations would not qualify to receive USG funds because they are not in accordance
with the MCA, i.e. they do counseling that encourages abortion or they actually do
abortions, they can in fact receive funds as long as they use them for treatment and not
abortion performance or counseling.  Major victory for me if Jay supports me since
otherwise many groups would be disqualified to participate in the  AIDS implementation
plan.  Also, according to the TRIPS (Trade-Related Aspects of Intellectual Property
Rights) agreement, the WTO countries would not permit breaking of patents or use of
generic.  However, in paragraph 6 of the Doha Ministerial Declaration on the TRIPS,
members could use “compulsory licensing themselves or have a third party compulsory
license for them to make drugs in the case of an epidemic emergency such as AIDS,
malaria, TB, cholera, Ebola, etc. so long as certain conditions are met such as this must
be in poor countries and drugs cannot be sold back to rich countries.  Thus, the TRIPS
agreement will not interfere with our giving money to poor countries to buy generic or
compulsory licensed drugs.  Please refer to TRIPS and Doha documents.
Released by Chairman Rand Paul
71Feb. 14 – Mar. 2 – I have been leading (with Stew Simonson and occasionally Mark
McClellan (FDA) many, many briefings of senators, Congressmen and staffers on Project
BioShield.  The WH has proposed our legislation.  Zerhouni is acting extremely insecure
and (I believe) inappropriate regarding the mentioning of NIAID in the authorizing
legislation for BioShield. He and Stew and having a terrible fight since Stew insists that
NIAID remain in the language. I am trying not to get caught in the middle.
A few days ago, I presented the Jimmy and Rossalyn Carter Award of the NFID
to former Congressman John Porter.
Mar. 3, 2003 – Had dinner with Senator Bill Frist in his Majority Leader’s Office in the
Capitol.  He regularly (on Mondays) brings together people with whom he likes to
discuss various topics.  This time it was bioterrorism.  Besides me was Herb Pardes,
Mark Halperin (NBC News), Stuart Taylor (Editor, National Journal), Georges Benjamin
(Director, American Public Health Assoc), Bill Madia (Oak Ridge), Rev. Anthony Davis
(Director, DC Black Church Initiative), Michael Byrne (Dept. of Homeland Security,
Coordinator for DC, MD, and VA) and Ginny Wolfe (Counselor to Sen. Frist).
Mar. 3 – 10, 2003 – Many briefings on Project BioShield.  Most recent on Mar. 10 at the
White House with the usual cast of people, i.e. Kristen Silverberg, Ken Bernard, Carol
Kuntz, Stew Simonson, Tom Reilly (OMB), some people from DHS and OMB.
Mar. 12, 2003 – Conference call with me connected to about 50 industry people
organized by John Kelly of PhRMA to explain BioShield to them.  Always a concern
about anti-trust laws and so the General Counsel for PhRMA (Ken Ewing) made sure that
no questions were asked by industry that would violate this.
2003 March 12
Teleconference on Pr
Stewart Simonson told me yesterday that he resigned because of serious clash
with Jerry Hauer.  I offered him a job at NIAID that he was very moved by.  Got a call
today that Secretary Thompson insisted that he does not resign.  Stew gave in to TGT.
Mar. 13 – 16, 2003 – We are getting closer to war with Iraq.  The French, Germans, and
Russians are threatening to block any attempt on the part of the USA to have the UN pass
a resolution that if Iraq does not immediately comply with Resolution 1441 and disarm,
the UN will use force to disarm them.  USA, Britain and Spain may go it alone.
I am extremely concerned about the appearance in Asia (Hong Kong, Quangdong
Province in China, Vietnam, Thailand, Singapore of a mysterious acute respiratory
syndrome.  Thus far 400 people, 150 in last week, 9 deaths.  We have no idea what it is,
but the attack rate nosocomially is very high.  More than 30 health workers in Hanoi got
infected from a single patient.  Many people on respirators.  The new disease is called
Severe Acute Respiratory Syndrome (SARS).
On evening of March 16, had a great dinner at Galileo’s in DC.  Host was Bono
who is in town to receive an award on St. Patrick’s day (March 17).  Small dinner at
which Bono paid very kind tribute to me for putting together the President’s Emergency
Released by Chairman Rand Paul
72Plan for AIDS Relief.  At dinner were Chris Grady, Bono, Sens. Leahy, Dodd, Santorum,
Steve Case and wife Jean, Comedian Chris Tucker, Josh Bolten and girlfriend (?name),
Jamie Drummond, Bobbie Schriver, Cardinal ? from DC, Father Perry and others.
Mar. 17, 2003 – Gala St. Patrick’s Day dinner and Award Ceremony from The Ireland
American League at the National Building Museum.  Humanitarian Award to Bono.
Chris and I sit at Bono’s Table as his guest. Bono recognizes me in his acceptance
speech.
Pres. Bush gives Saddam Hussein 48 hours to leave Iraq or we will attack.
Mar. 18, 2003 – Senate passes Project BioShield Bill.  I hold meeting on
Medical/Chemical Biodefense Research at the Bethesda Hyatt as a sequel to February 26
meeting on Radiological Biodefense.  I am trying to frame the landscape of this to pursue
an appropriate research agenda.
Mar. 19, 2003 – Bombing of Iraq begins.
Mar. 19-28, 2003 – Major focus on war. Push towards Bagdad; massive precision
bombing; Iraqi irregulars have executed GIs on El Azeera TV to the horror and anger of
USA;
SARS is getting out of control.  1500 cases and 53 deaths worldwide.  At first,
investigators isolated a paramyxovirus (metapneumovirus) at first seen on EM.
However, this may have been a mistake since several groups led by CDC are now finding
an unusual form of coronavirus (common cold).
Briefed the VP on SARS and recent cardiac complication of smallpox vaccine via
teleconference.
March 27 – Testified with Secretary Thompson on Project BioShield at the House
Energy and Commerce Committee.  Several members (mostly Democrat) are balking at
the mandated appropriations authority.  They are reluctant to give up the power of the
purse.
March 28, 2003 - I gave a talk on Bioterrorism at the American Dental Association
meeting in DC on March 28.  The last person to come to the microphone to ask a
question after my talk said that he had waited many years to publicly address me.  He
related that in 1979, his 7 year old daughter was gravely ill on a respirator with a diffuse
autoimmune-like disease that her doctors could not figure out.  She was moribund and
they were about to give up on her.  A doctor said that there was only one doctor in the
country that he thought could come up with something and so they called me.
Apparently, I spent over an hour on the phone walking through with them a plan for the
patient that included plasmapheresis together with cytoxan and prednisone.  Within days,
his daughter began improving, got off the respirator, spent over a year in rehab, graduated
high school, went to Barnard College, graduated first in her class, became a Ph.D.
pathologist, got married and had a child.  She is entirely well now.  He said that he just
wanted to thank me publicly for “saving his daughter’s life”.  The audience gave me and
him a standing ovation.  It was one of the most moving things that I had experienced.
Released by Chairman Rand Paul
73March 29 – April 1, 2003 – It is hitting the fan.  SARS is getting out of control.  More
than 1800 cases and 62 deaths worldwide.  3.6% mortality.  Clusters of cases appearing
mostly in Hong Kong and China.  Now there are 17 countries.  USA has 72 cases in 27
states – no deaths yet.  It appears that it is spread by respiratory droplets, but also recent
evidence that by fine aerosal and objects – not unlike other coronaviruses.
I will brief the POTUS this week on SARS.  The war in Iraq is raging with troops
engaging the Republican guard close to Bagdad.  More myocarditis complications with
smallpox vaccine.  What a week so far!!!
April 4, 2003 – Big day!  US army captures Iraq International Airport.  I testify before
the House Government Reform Committee on the subject of Project BioShield.  Mark
McClellan testifies with me.  The House (Shays, Waxman, Chairman Case generally
support the concept of BioShield, but have some concerns such as with the “permanent”
and indefinite Appropriations Authority.  After the Hearing I, together with Julie
Gerberding and Tom Ridge, brief President Bush, Laura Bush, VP Cheney, and the
senior White House Staff on SARS and Smallpox vaccine program.  We bring executive
order to the POTUS on quarantine for SARS and he signs it.  At meeting are Josh Bolten,
Karl Rove, Ari Fleischer, Richard Falkenrath, Adm Steve Abbott,, etc.  POTUS and VP
as usual very warm and complimentary to me and to Julie.  After the meeting, I spoke
with Josh Bolten and volunteered to go to Iraq for the President if the Iraqis use
biological, chemical or radiological weapons on our troops.  I offered this to allow a
public appreciation of the link (my being a civilian health authority) between Iraq and the
danger of bioterrorism against the USA civilian population.
April 5-9, 2003 – Incredibly busy.  I have testified at >6 Congressional Hearings over the
past few days on SARS, Appropriations, AIDS, Biodefense, etc.  SARS is spreading.
Have been on many network TV shows discussing SARS – CNN (several different
shows), Good Morning America, News Hour, CNBC, etc.  Iraq is falling; Bagdad
occupied by US troops.
April 10, 2003 – Wonderful day.  Went with Chris ( my father, Denise and Jack Scorce
were also there) to Ellis Island to receive the Ellis Island Family Heritage Award.  Other
awardees included Yogi Berra, Bob Hope, Cicely Tyson, Abie Abraham (hero of the
Bataan Death March).  It was a wonderful ceremony with a fantastic video of my history
including the ship’s manifest with my grandfather Antonio Fauci’s name.
April 11 – 18, 2003 – Iraq war over as troops occupy essentially all of Iraq.  Saddam
missing as is most of Iraqi leadership.  Much attention now focusing on SARS.  Cases
now at 3400 with 175 deaths.  Much media interest.  For example, on April 17 alone I
appeared on Channel 5 News, Diane Rehm Show, Charley Rose, CNN’s Aaron Brown,
and CNN International in addition to several print media.
April 19, 2003 – Just an unrelated historical note to put all of this in perspective.  My
daughters are doing marvelously well in school and sports.  All 3 are virtual straight As
(an occasional A-). Megan and Ali excel in gym and Jenny is doing extremely well in
multiple varsity sports.  She clearly is the best varsity diver at NCS.  She is on the first
Released by Chairman Rand Paul
74team varsity for cross-country and just this year (junior year) has taken up crew.  She
loves it and is a starter on the varsity 4 person lightweight boat.  Thus far, they are 3 for 3
in meets; I saw a meet at the Georgetown Harbor today.
April 20-28, 2003 – War is essentially over. Still no weapons of mass desctruction. Still
doing an incredible amount of press.  Did This Week with George Stephanopoulos on
Sunday, 27th April.
April 29, 2003 – Amazing day!!!  Spoke at a Republican leadership lunch at the Senate
together with VP Cheney.  We were there to promote S-15 (the legislation for BioShield).
I was extremely warmly received by the Senators with many complements from Sens.
Frist, Hatch, Stevens.  I presented my thing and then the VP got up and praised me for
my leadership on Project BioShield and made a few comments on the threats.  We
(Ginger Loper and I) next took the WH limo to the WH for the President’s ceremony on
the Emergency Plan for AIDS Relief, aimed at drumming up support for the legislation
for the plan’s funding. The ceremony was supposed to be in the Rose Garden, but was
moved to the East Room because of weather. The President was wonderful to me,
specifically winking and saying “Hello Tony” as he was scanning the crowd.  He then
made the comment in his speech to the group that he wanted to specifically thank me for
all of my work on behalf of mankind.  After the ceremony, he specifically came down to
greet people and put his arm around my shoulder and thanked me again for all that I have
done.  It was a terrific day.
April 30-May 1, 2003 – Much effort on my part in working the Congress (briefing
Senators and Congressmen and staff) in support of Project BioShield.  Clearly the
reluctance on the part of the Congress has to do with not wanting to give up the control of
the “purse” to a mandatory and indefinite appropriations authority.
May 2, 2003 – Did “Field Hearing” in Harrisburg, PA for Sen. Specter on SARS.  He is
running for re-election and clearly wanted to impress his constituents.  It worked.
May 3, 2003 – Great evening.  I received the “Golden Plate Award” of the Academy of
Achievement.  It was a Gala affair at the Mellon Auditorium in Washington, D.C. I was
on a panel chaired by Mike Wallace of “60 Minutes” during the day and had a black tie
dinner in the evening.  Other awardees were Jose Carreras (did not show), Hillary
Clinton, Sen. Tom Daschle, Bob Dylan, author and Washington Post columnist Thomas
Friedman, Rudy Giuliani, Donald Graham (CEO of Washington Post), Baroness Susan
Greenfield, Dr. Robert Sanger, Leonard Lauder (CEO of Estee Lauder), Trent Lott, John
McCain, Simon Peres, Franklin Raines, Justice Antonin Scalia, Robert Strauss,
Archbishop Desmond Tutu, Alvaro Uribe Velez, President of Columbia.
The banquet was attended by all of the Glitterati including President Clinton who
was the hit of the night, dancing away like crazy .  It was a wonderful time with
incredible entertainment including Patti Austen, Ray Charles, Aretha Franklin, and
Chuck Berry who drove the house down.
Released by Chairman Rand Paul
75May 3 to 13, 2003 – Spending almost full time working with White House on trying to
shape the BioShield Legislation with the Senate and House.  I have daily been briefing
senators (such as Sen. Byrd) and staff of the House as well as members such as Henry
Waxman, Chris Cox, Fred Upton, etc. on why they should support the President’s (Sen.
Judd Gregg’s) Bill.  Congress is reluctant to make the purchase authority “Mandatory,
permanent, and indefinite”  It seems now that we are winning the battle for mandatory,
but it is going to be tough to get permanent and indefinite.  We will have to settle for a
cap according to the budget resolution and a sunset at 10 years.  People at the White
House that I am working closely with are Ginger Loper, Candi Wolff, Carol Kuntz, Ken
Bernard, Chris Cox, Mike Allen et al.
Also, during this time I gave the Commencement Address at Emory in front of
14,000 people and received an honorary degree.
May 14 – 20, 2003 – Continued doing Congressional briefings and Hearings on
BioShield and SARS.  The epidemic is appearing to come under control.  Spent sometime
today (May 20) helping the White House write the POTUS speech on the AIDS initiative.
Wonderful thing happened yesterday.  The WH is planning a signing ceremony for the
AIDS Bill ($15 billion authorization).  It was originally schedule for May 28.  I wrote an
e-mail to Gary Edson and Jay Lefkowitz saying that I had to give the Commencement
Address at SUNY Downstate on May 28 and if it occurred then, would they send my
regrets to the POTUS.  Jay responded by e-mail that since I was the honored guest, they
will change the ceremony to May 27.  Amazing!
May 20 – 27, 2003 – Busy time for Bioshield and giving Commencement Addresses
(Emory, Albany Medical, Univ. of MD and SUNY Downstate) and receiving honorary
degrees (Emory, Albany, Univ. MD, Yale).  Major article (feature piece) on me in the
weekend edition of The Financial Times; mostly very flattering with the usual few
jealous comments from “unamed sources”.
May 28, 2003 – Historic day.  President Bush signs the Authorizing legislation for the
President’s Emergency Plan for AIDS Relief in the Dean Acheson Auditorium of the
State Department.  Again, he specifically thanked me in his speech for my work on AIDS
and for being there.  I was given a “seat of honor” in the first row.  In his speech the
President used word-for-word the sentence that I composed for him describing the
initiative as the “largest single up-front commitment in history to an international public
health initiative involving a single disease”
May 31, 2003 – Extraordinary feature article on me in The Financial Times with full
page picture and complimentary story.
June 8, 2003 – Feature story on me in the nationally syndicated Parade Magazine of The
Washington Post.
June 8-18, 2003 – Continued activity and briefings, conference calls concerning the
Bioshield Legislation.  White House still relying me on pushing the prospect of
Released by Chairman Rand Paul
76mandatory versus discretionary funding for Bioshield.  Also a number of network and
CNN TV appearances on emerging disease including SARS and monkey pox.
June 18, 2003 – Went to West Wing of WH to brief General John Gordon the new
Director of the WH Office of Homeland Security and Special Assistant to the President
for Terrorism.  I briefed him on what the NIH Biodefense Research Agenda was.  Good
guy.  We had a nice discussion.
Also, delivered a standing room only Grand Rounds at the Lipsett Auditorium on
SARS.
June 19, 2003 – Appeared on a panel at the Council of Foreign Relations with Ted
Koppel (Chair), Patti Stonesifer (Gates) and Senator Durbin to discuss “Are we prepared
to deal with global pandemics?”.
June 20, 2003 – Appeared on CNN’s Lou Dobbs show to discuss emerging and re-
emerging diseases.
July 2, 2003 – Attended White House ceremony for the announcement of Randall Tobias
as the Coordinator of the President’s Emergency Program for AIDS Relief.  Randy is
former CEO of Lilly.  Pres. (as usual) mentioned me and said that it was an honor to have
me there.  I strongly recommended to TGT that Mark Dybul be appointed in the State
Department to the new program to help Joe O’Neill who was clearly emerging as the
second in command.
July 2 – 7, 2003 – Much attention paid to post-war guerilla action in Iraq with several
USA service people getting killed in terrorist/guerilla action.
July 8, 2003 – Attended meeting in Situation Room of the White House chaired by
Richard Falkenrath. Attending were Deputies of all of the relevant agencies, Carol Kuntz,
Ken Bernard, Jorge Tavel, Bob Kadlac etc.  Purpose was to agree upon a long range Plan
for SARS called CONPLAN.  Also, discussed revamping the organizational structure
among the various Agencies for a coherent Biodefense Agenda.
Appeared on CNBC’s Capitol Report with Alan Murray and Gloria Borger to
discuss the President Bushes Emergency Plan for AIDS Relief.  I had the opportunity to
praise the POTUS for his leadership in this Plan.
July 9, 2003 – Visited new AIDS Coordinator for the Plan (Randall Tobias) at the State
Dept. and briefed him on how the President’s Plan came about and how I suggest he
implement it.  I strongly suggested that he get Mark Dybul to work for him since Mark
was so important in putting the details of the plan together.
July 12-18, 2003 – Trip to Paris for the 2nd Annual International AIDS Society (IAS)
meeting.  I gave the “Extraordinary Plenary” lecture on Monday, July 14 on the topic of
“HIV and AIDS: 20 Years of Science”.  I was immediately followed by Nelson Mandela
who gave a lecture on the societal aspects of 20 years of AIDS.  My talk was extremely
well received; many said that it was the best talk that they had ever heard me give.  There
Released by Chairman Rand Paul
77were >5000 people in the main auditorium at the Palais de Congres in Paris.  Of
particular note was the fact that prior to leaving for Paris, Dr. Brian Brink who is the
Senior Vice President for Health of  Anglo American Corporation, a gold mining firm in
South Africa had contacted me.  Brian is an advisor to Mr. Mandela on HIV/AIDS and
was asked to write Mandela’s speech for the meeting.  Brian called me and asked for
suggestions about what Mandela should say.  I mentioned to Brian that Mandela had been
seriously criticizing Pres. Bush for the Iraq war and that it would be very important for
Mandela to publicly congratulate and praise Bush for the $15 billion Emergency Plan for
AIDS Relief.  I said that Mandela would lose credibility if he did not do this. I even made
up a paragraph for him to put into the speech.  Brian agreed, but said there was no
guarantee that Mandela would actually include it in the speech.  To my great pleasure,
Mandela included the paragraph practically word-for-word.  I let Jay  Lefkowitz  know
about this by e-mailing him from Paris.  Jay was very pleased and said that he would
mention this to the President.
July 19-30, 2003 – Have had a number of briefings with TGT as well as the VP’s staff
(Carol Kuntz et al) on various subjects such as smallpox, anthrax, SARS, etc.
Constituencies still upset that NIAID will have to do advanced development and some
procurement of rPA anthrax vaccine to the tune of about $250 million even though the
Congress removed the $250 million from our budget that OMB put in to do this.  Josh
Bolten (now OMB Director, replacing Mitch Daniels) has allowed us to spend this over 2
years instead of 1 year.  Nonetheless it will be a burden.  There are philosophical
questions here regarding how much advanced development should be done by NIAID
versus the drug companies.  We are trying to allow BioShield to pay for some of the
advanced development instead of limiting it just to the actual procurement of
countermeasures.
August 1, 2003 – Briefing at the White House.  Two parts to the briefing.  Jorge Tavel
and Heather Wingard of CIA briefed on threat assessments and I briefed on
Countermeasure Development.  Present at briefing were:  Carol Kuntz, Stewart
Simonson, Andrew Hallman (CIA), Heather Wingard (CIA), Dr. McCreary (DHS), Bill
Parrish (DHS), Parney Albright (DHS), Sally Stanfield (DHS), Ken Bernard (OHS),
Jorge Tavel (OVP), Richard Falkenrath (for while, OHS), Julie Gerberding (CDC)
Carol was very pleased with my presentation as I touched on all of the points that
we had previously discussed with the Vice President such as genetically modified
organisms, botulism, etc.
August 1 – 21, 2003 – Summertime lull.  Usual issues.  Zerhouni pushing his “Roadmap”
agenda .  Few people can figure out what it really is and how it will be implemented.
IOM report on the “Structure of NIH” came out.  As usual, they commented on things
that they were not asked to comment on.  They pushed having greater resources in the
Office of the NIH Director and having more “high risk” research to be managed out of
the OD as well as trans-NIH research planned out of the OD.  Seems like Zerhouni wrote
the report.  Also, and amazingly, they recommend 5 year term limits for IC Directors
with the possibility of only 1 five year renewal.
Released by Chairman Rand Paul
79of having the NIH Recombinant DNA Advisory Committee (RAC) serve as a mechanism
to provide a “culture of responsibility” among scientists similar to what was done in the
mid-1970s. At the briefing was the usual people – Gen Gordon, Ken Bernard, Richard
Falkenrath, Carol Kuntz, several DoE people, WH communications people, etc.  Decision
was to put together a briefing for the Secretaries.
Sept. 18 –19, 2003 – Went to NYC to give Plenary Lecture at the AIDS Vaccine 2003
meeting.  While I was there, Hurricane Isabel hit Washington, D.C. and there was
widespread devastation with major power outages (3 million people in DC, VA, and MD
without power).  Power not expected to be restored for at least 1 week.
Sept. 24, 2003 – Power back finally.
Sept. 25, 2003 – White House meeting with Jay Lefkowitz, Gary Edson, Mark Dybul,
Joe O’Neill, Carol Thompson to discuss the controversy regarding $2 Billion versus $3
billion in FY ’04 for the President’s $15 billion, 5 year plan.  Bono and other activists
want a full $3 billion in ’04.  However, if we did that, then we would put less in ’05, ’06,
etc.  I recommended to Jay et al to stick with the Plan and leave flexibility to match other
funds by 1/3.  See below my e-mail to Jay from 9/25/03:
Jay/Gary:
Just a recap of my suggestion from this afternoon for your consideration.  Mark was on
the same page on this also. I believe that we must remind people and strongly underscore that
the President's Plan is a $15 billion program over 5 years involving 14 countries. Within the
context of such a plan (we must emphasize this point), the best way to spend the money and
thus to save the most lives is by phasing in with $2 billion in the first year and more than $3 billion
per year in subsequent years.  We all realize that more money can be spent globally on AIDS and
thus more lives can be saved. This is a no-brainer.  We never said that the President's Plan of
itself would cover all of global AIDS.  We should not get into an "absorptive capacity" argument
since no matter how clear we are, people will confuse absorptive capacity in the President's Plan
of 14 countries and absorptive capacity for the rest of the developing world.
I suggest that we take a 2 pronged approach. 1) We stick with the President's Plan as it
has been outlined, and; 2) We publicly recognize that more money can indeed be spent on AIDS
globally.  We are hoping that other countries will follow the President's lead and put more money
into programs either bilaterally or through the Global Fund. In fact, we are willing to go the extra
mile and to contribute 1/3 of the global effort if other countries rise to the occasion. In '03, the
world total was $3.6 billion with $1.4 billion by us (39%).  Since we are giving $2 billion in '04, the
rest of the world should give $4 billion.  If the rest of the world gives more than $4 billion, we will
match them by 1/3.  Thus, if they want us to give $3 billion in '04, the rest of the world must total
$6 billion.  If this happens (which it will not), then we will put the additional money into a mix of
Global Fund and other countries (beyond the original 14) bilaterally. In this way we show
leadership and flexibility.  If no one else gives an additional penny, we still are committed to the
President's Plan as we have outlined.  If other countries meet the above mentioned benchmarks,
then we are flexible enough to match them by 1/3.  Finally, if the Congress appropriates a couple
of hundred million over the $2 billion and the President signs such a Bill, we would give that
additional money to the Global Fund and/or additional countries and back up our contention that
our funding plan for the 14 countries is indeed sound.
I would be happy to discuss this further with you.
Thanks,
Tony
Released by Chairman Rand Paul
80Sept. 26, 2003 – White House meeting on Bioshield with the usual suspects – Stewart Simonson,
Jorge Tavel, Ken Bernard, Bill Winkenwerder, Larry Kerr, etc.  We are getting ready for finalizing
the legislation.  After the meeting in the EEOB, I went over to the West Wing to see Richard
Falkenrath.  NIAID will be awarding 2 NBLs (BSL-4 labs) and  9 RBLs (BSL-3 labs) on Sept. 30.  I
have been getting incredible lobbying pressure from people like Sen. Hillary Clinton and others
for their state or district sites.  Chicago is in the running for an NBL and the President is going to
Chicago on Sept. 30.  The WH wants me to delay the announcement until 2:00 PM after the
President leaves Chicago since Chicago got an RBL, but not an NBL and the WH wanted to
avoid any embarrassment for the President to be there when bad news arrived.
Oct. 7, 2003 – Briefing in the Situation Room of the White House for Andy Card on the
Craig Venter issue of synthesizing microbes.  Also at the meeting were:  Tommy
Thompson, Spencer Abraham (Secr. Of DoE), Dan Bartlett; General Gordon; Ken
Bernard, Harriet Miers (Card’s Deputy), Bob Card from DoE, Ray Auerbach (DoE),
Bruce Alberts (NAS), Gerry Fink giving summary of Fink Report on “Biotechnology
Research in an Age of Terrorism”, which is an NAS/NRC report; Stewart Simonson;
Carol Kuntz; Larry Kerr;   I have essentially been adopted by the WH to be the one who
explains the science of Venter’s work.  This, I was the major briefer. Also, I have been
spearheading the NIH effort to create a subcommittee of the RAC to provide the “culture
of responsibility” for the scientific community on these issue similar to the 1970s with
the RAC following the Asilomar Meeting in 1974.
Oct. 13, 2003 – Went to White House ceremony (President’s speech) and reception to
commemorate Columbus Day.  The President specifically greeted me in his remarks
saying how proud he was of how I was the General in the Global War on AIDS.  After
the ceremony, I ran into Josh Bolten in the hallway of the EEOB.  He asked about my
opinion of the controversy of $2 billion versus $3 billion in FY ’04 for the President’s
Emergency Plan for AIDS Relief.  Bono has been giving the WH a hard time saying that
the President was reneging on his promise when in fact he promised $15 billion over 5
years staring with $2 billion in ’04 (see above).  He specifically asked my opinion of how
Randy Tobias was doing as the new AIDS head of the program.  He indicated that he did
not think that there was anything wrong, but that he was getting the vague feeling that
things were not moving along as aggressively as he thought that they would be.  He asked
me to quietly check it out.
Oct. 16, 2003 – Had breakfast (at his invitation) with Jay Lefkowitz at the White House
Mess to say goodbye.  He is leaving as Director of  Domestic Policy Council to return to
his law firm in its NYC branch.  He will likely return after 2 years for the President’s 2nd
term (if this occurs).  We had a great conversation in which he mentioned how honored
he was to work with me on the President’s Emergency Plan for AIDS Relief, the MTCT
plan and to a lesser extent on the stem cell issue.  I sincerely told him that he was second
to none in people that I have worked with at the WH over the past 19 years.  He asked my
help in making sure that the AIDS Plan does not get derailed by the mischief of USAID
in trying to lobby the legislation such that power is taken away from Randy Tobias and
he would not be given an independent account.
Oct. 17, 2003 – Went to going away reception in Indian Treaty Room of EEOB at White
House in honor of Jay Lefkowitz.  Great time just talking to the White House crew and
Released by Chairman Rand Paul
81others that I have gotten to know over the past 2+ years: Jay, Margaret Spelling, Kristen
Silverberg (just back from Iraq and will replace Jay), Karl Rove, Scooter Libby, Josh
Bolten, Ginger Loper (WH Leg. Affairs), Terrell Halaska, Allen Gilbert, Mark McClellan
(FDA), Scott Whitaker, Ladd Wiley, Alex Lazar, etc.
Oct. 24, 2003 – Met with Sen. Barbara Mikulski to try to convince her not to support
Rep. Chris Van Hollen’s attempt to block the construction of the biodefense building
(Bldg. 33) on the NIH campus and move it to Ft. Detrick.  He keeps calling it a bioterror
building. She was sympathetic, but indicated that we must engage the community more.
Fact is….we have been doing this, but a very recalcitrant few do not want to building on
campus no matter what.  This is the same group that did not want to fence put up around
NIH.  This is a political issue since Van Hollen made 2 campaign promises: 1) no fence;
and 2) no biodefense building. He already lost the first and does not want to lose the
second.  We will try to work with him.  Also present at the meeting were several of
Mikulski’s staff, Elias Zerhouni, John La Montagne, and Marc Smolonsky.  Also, I
hosted Julie Gerberding to deliver the NIAID Joseph Kinyoun Lecture and then took her
to dinner with John La Montagne, Ed Tramont, Pamela McInnes.
Oct. 25, 2003 – Had biodefense strategizing meeting at Wye River Conference Center
run by Richard Danzig.  Discussed issues related to dealing with mass casualties.  The
usual suspects were there – DA Henderson, Julie Gerberding, David Franz, Michael
Osterholm, Bill Patrick, C.J. Peters, George Tavel, people from DoD, FBI, CIA, etc.
Oct. 27, 2003  - Had a Policy Coordinating Committee for an “end-to-end” analysis of
biodefense responsiveness at the White House EEOB.  Meeting run by Ken Bernard and
Bob Kadlec.  Attended by all the usual suspects from each agency – CIA, FBI, DHS,
HHS, OMB, OVP, etc.
     After the meeting I met with Bob Kadlec about the possibility of going to Iraq to
interact with the medical and research community.  Apparently, the copies of HPIM-15
that I had sent to Iraq through Kristen Silverberg were a smash hit and the Iraqis want
very much for me to go to Iraq.  However, over the past few weeks there has been a great
escalation of insurgency and terrorism with many suicide bombings and rocket and rocket
propelled grenade attacks on both military and civilian targets.  It appears that the
terrorists are targeting the Iraqis who are cooperating with the USA in trying to rebuild
the country.  Kadlec does not trust the security associated with the ministries of health to
provide for my safety.  He actually feels that if word gets out that I am coming that I
would be targeted by snipers.  He feels that if I go, he will arrange for CIA operatives to
get me into the country and move around “under the radar” and that CIA operatives
would provide my security.  We decided to wait a few weeks before resuming plans
about going to Iraq and consider going in January/February.  Bob will have to go there at
this time anyway to continue search for weapons of mass destruction.
Oct. 29, 2003 – Met with Ray Gilmartin (CEO of Merck) and Adel Mahmoud (Merck) to
discuss ways that Merck can collaborate with NIAID in AIDS and in biodefense.  Great
meeting.  Also, discussed how Merck can interact with BioShield process.
Released by Chairman Rand Paul
82Nov. 3, 2003 – Carol Kuntz informed me that the Vice President wants me to brief him
on what we are doing with Rad/Nucl research and countermeasures.  This is tough since
this is not really my issue; however, the VP wants it and so we will put something
together for him
Nov. 5, 2003 – Meet in my conference room with Israeli Ambassador to the USA –
Daniel Ayalon to discuss potential for collaborations with Israel.  We got along very
well; he is quite engaging.  We discussed scientific collaboration as well as our difficult
situation in Iraq with the insurgency and terrorism.
Nov. 6, 2003 – Meeting at the EEOB (White House) to discuss how I will brief the VP on
Nov. 20, 2003.  VP wants me to take care of the Nucl/Rad countermeasure situation since
he does not have confidence in the scattered others.  Issue is that this is not my primary
area of expertise.  He wants me to do it anyway.  Nice compliment, but this will be a lot
of work.
Also, Anthrax situation evolving at Anacostia Naval Post Office.  Possibly
contaminant.
Nov. 7, 2003 – Still sorting out the likely anthrax contaminant at the Anacostia Post
office.
 Met in my office today with  the South African activist who last
year refused to be treated with ART for his HIV because the S. African government was
not providing treatment for the rest of the country.  He is a very gentle person and a true
hero.  He just wanted to come and meet with me.
Nov. 13, 2003 – Met with the PCC (Policy Coordinating Committee) regarding the
response to the Fink report.  The PCC adopted for the most part the responses of the
DHHS to the Fink report.  We (Stewart Simonson, Stuart Nightingale, Amy Patterson,
Lana Skirboll, John La Montagne) have been working on DHHS’s response for several
weeks now.
Also, I was on conference call this afternoon with Secret Service, DHS, DHHS,
FBI regarding a letter that contained ricin that was sent to Greenville, SC; however, now
a letter addressed to the White House also containing ricin has been discovered.  The
discussions among the Secret Service, FBI, Department of Transportation, etc. is chaos.
It is somewhat embarrassing.  The discussion centered around the investigation and not
the public health issues until DHHS (Bob Blitzer) brought up the fact that we really need
to find out who might have been exposed.  This phone call was like the Keystone Cops!
Nov. 14, 2003 – Continual conference calls regarding the ricin incident.  It turns out that
someone crushed some castor beans and stuck crude material into an envelope to
blackmail the Dept. of Transportation.  Letter was also sent to WH.  Bottom line – no
health threat.
Nov. 20, 2003 – Went to West Wing of WH to brief VP Cheney on Nuclear and
Radiological Threat Countermeasures.  As I was crossing Pennsylvania Avenue to enter
West Wing at 9:30 AM, there was an alarm that a small aircraft had encroached upon
Released by Chairman Rand Paul

83WH airspace.  WH was evaculated and many machine gun armed Federal police
appeared.  After  a while they let us in, but the VP had already been scooped off to safety
and so the meeting was cancelled and rescheduled for a few days from now.  President
Bush was in UK at the time.
Nov. 25, 2003 – Briefed the Vice President  today with Scooter Libby, Stewart
Simonson, Carol Kuntz and Jorge Tavel in attendence.  I spoke about
Nuclear/Radiological countermeasures and our need for a strategic plan and the need for
someone (us – DHHS/NIH) to take the lead in this since the effort is fragmented and
DoD has been neglecting this area since the end of the Cold War.  I also gave him a
progress report on our microbial biodefense program.  He loved both presentations and
related to Carol, (who told me) that the briefing was “very impressive, very impressive,
in fact great!”  I am still having trouble with Zerhouni who is infuriated that the VP’s
people are “excluding him” from these briefings.  In fact, they merely maintain that the
VP does not like crowds and he does not like the chain of command to be present on
briefings to him.  Zerhouni cannot accept that.  I am trying to explain this to Zerhouni,
but he is just plain angry.
Nov. 28, 2003 – Significant Influenza A activity already with a variant strain (Fujian) that
is not contained in current vaccine. This is quite early for heavy burden of influenza
cases. 4 deaths of children in Colorado.  Concern mounting that we will have a very bad
year.  I have been on CNN (X2) CNBC and Good Morning America over the past 2 days
to talk about this.
Dec. 1 – 7, 2003  - Trip to Africa as part of Secr. TGT’s delegation.  Cameroon (fuel stop
+ ambassador handshake), Zambia, Rwanda, Kenya and Uganda.  Most incredible visit.
Included Julie Gerberding (CDC), Elias Zerhouni, Randy Tobias (Ambassador for
President’s Emergency Program for AIDS Relief (PEPAR), Richard Feachim (Director
of Global Fund for AIDS, Malaria, and TBC),  Peter Piot (UNAIDS), Amb. Richard
Holbrooke (UN Ambassador for Clinton, now representing business coalitions), Bill
Winkenwerder (DoD), Senator Don Nichols (R-OK), Congressman Dave Weldon (R-
FL), Linda Conlin (Assist. Secr. For Trade Development, Dept. of Commerce, Ann
Peterson (USAID), plus many other VIPs plus a large number of CEO-types in industry
such as Hank McKinnel (CEO-Pfizer), CEO Peter Dolan of BMS, Chris Viehbacher
(Pres., GSK), John Martin (CEO, Gilead), Per Wold-Olsen (Pres. Merck Europe/Middle
East/Africa), etc.  In addition, many people from faith-based organizations such as Father
O’Brien (Pres. Les Aspin Center at Marquette) and Shepherd Smith (Institute for Youth
Development).  Christy Feig from CNN was on board as was Sabin Russell from San
Francsico Examiner and Marilyn Marchione from Milwaukee Sentinel. Purpose of the
visit was fact finding and to get industry involved in economic impact of AIDS in Africa.
      So many incredible aspects to trip with the underlying theme that the Africans
(particularly in Uganda) are showing that they are ready for implementing the PEPAR
and the Global Fund (see below the experience in Tororo, Uganda). Also, many new
friends from the delegation.
Zambia (Dec. 1-2) –  Greeted by US Ambassador Martin Brennan and Zambian
Minister of Finance and Economic Development Emmanuel Kasonde and Zambian
Released by Chairman Rand Paul
84Minister of Health Brian Chituwo. Stayed at the Zambezi Sun Hotel at the evening had a
local dinner (open pit outdoor barbecue) at a Boma. Also, walked down to Victoria Falls
which was absolutely breathtaking. Looked across the Zambezi River to Zimbabwe.
Participated in a World AIDS Day parade through the city  center of Livingston. Many
locals came out to greet us. Visited a faith-based organization St. Francis Community
Home-Based Care Center as well as LISCA Linda Center giving care to children – called
LISCA.
 Rwanda (Dec 2-3)  On afternoon of Dec. 2, flew to Kigali, Rwanda and
immediately went to the Genocide Memorial.  Clearly this was one of the 2 most
important parts of the trip.  I spoke with many Rwandans who suffered from the genocide
and the enormity of it really is not appreciated by the world in general.  In 1994, over a 4
week period in April, the majority Hutus slaughtered 800,000 to 1 million Tutsis while
the world watched and did nothing.  In fact, the French actually came in to protect the
Hutus against Paul Kigame’s  (Tutsi) rebel army that came in from Uganda to stop the
massacre.  I ultimately had an audience with now-President Paul Kagame in the
Presidential Palace.  We also spoke with many Rwandans whose families escaped.
(Please refer to history books about the massacre).  Of not, as in my visit to South Africa
in 2002 vis-à-vis Apartheid, the Rwandan Society in dramatically impacted by the
genocide.  Most ministers are people who fought together with Kagame to stop the
genocide.  Those who were there said that atrocities were unimaginable.  Machete-killing
of tens of thousands of people, women, children per day until bodies cluttered the streets
and the rivers.  Of note, 13% of the population of 8.2 million are infected with HIV and
so AIDS potentially will kill more people than the genocide massacre. During visit, met
with US Ambassador Margaret McMillion. Visited Kabgayi Hospital 1 hour outside of
Kigali. TGT gave a gift of a cow named “Elroy” (after his hometown in Wisconsin). On
the previous night (Dec. 2) we had an extraordinary discussion among the delegation.
We had just received a high red alert that there would be a terrorist attack against US
interests, particularly hotels and possibly ground to  air missiles at aircraft in Kenya the
next day. There was a frank discussion at dinner at the Milles-Collines Hotel among
delegates led by Jay Hodes (chief of DHHS Security) and TGT.  Decision was that
anyone among government people could opt out and go straight to Uganda skipping
Kenya; however, all non-government people were bumped off and sent directly to
Uganda except for a very few like Sabin Russell and some others. I definitely wanted and
did stay with the group as did Julie Gerberding and Elias Zerhouni.  The Milles Collines
Hotel was where the Hutu Command post was during the genocide.
The next day we went to Kabgayi (see above), then flew to Entebbe Airport
Uganda, left off about 70 people and the remaining 25 – 30 went back to Kenya. We
were flying on a German Charter (same one as last year with German pilot Chris who
formerly was a Luftwaffe Major).  On the approach to Nairobi airport, Chris slowed
down for about 15 minutes to “cool” the engine ( to decrease chance of hear-seeking
missiles) and then dove sharply to the landing field.  All went well.
Kenya (Dec 3-4).  In Kenya, we went to a rather boring Global Coalition Event
and then had a reception at the residence of US Ambassador William Bellamy.  Security
was depressing. From the airport, we were escorted downtown by a truck-load of Kenyan
Army soldiers all with AK47s.  The entire perimeter of the hotel was blocked off to
Released by Chairman Rand Paul
86husband and other brother-in-law.  She is not abused by her in-laws and states proudly
that they love her very much.  It was clear from their reaction that she was correct.
After Tororo, we went to the Grandmother’s (JAJA/Mildmay) house in Jinja,
Uganda.  This was a beautiful facility that was more a referral facility that a primary care
place.
Next day (Dec 6) went to Mulago Hospital grounds and visited the TASO Mulago
Center for a ribbon cutting of a new building largely built by Pfizer through  a donation
from Hank McKinnel. It is a beautiful facility. After this we went to Entebbe and visited
the Uganda Viral Research Institute on Lake Victoria.  I gave a small speech.  The Rakai
group supported by NIAID gave a booth presentation led by Noah Siwanuka (Spelling?).
After this we had dinner at the Lake Victoria Hotel in Entebbe and took off for Frankfurt
right after midnight on Dec. 7 with a fuel stop in Larnaca, Cyprus.
General Comments: See above in Introduction.  Also, in Uganda, CDC program
director Jonathan (Jono) Mierman was wonderful…very enthusiastic and good-
aggressive person. Also, interacted with Minister of Health Jim Muhwezi. He has an
interesting history.  He is trained as a lawyer, was a political activist against Idi Amin and
Mobutu.  Was jailed, shot himself (3 escaped and 1 was killed) out of jail, escaped to a
hotel that was surrounded by hundreds of troops that were looking for him.  He dressed
like a woman and slipped away right in front of the soldiers.  He escaped to the North
where he joined Museveni.  He became a Brigadier General in the Ugandan resistance
army and after Museveni won, he was made chief of intelligence.  After 10 years there,
he was made Minister Of Health.  Similar to the Kagane story in Rwanda, practically all
of the ministers started off as fighters in the resistance army with the person who
ultimately became President, in this case Museveni.  None of these places are really a
democracy since opposition parties are generally restricted.  It just happens that
Museveni is an enlightened President.
Became friends with Tommie Thompson, TGT’s daughter who is very nice.
Also, developed beginnings of bonding relationships with many people including Sen.
Nichols, Cong. Weldon, Randy Tobias, Richard Holbrooke and many of the staff at HHS
that I already knew well, as well as Elias Zerhouni.
As experienced as I am, I was greatly moved by the trip.  I learned much and was
deeply moved by the experience in Tororo.  I felt so good and yet humbled about my role
in developing the $15 billion PEPAR program.  It may turn out to be my greatest
accomplishment.
Dec 7, 2003 – Major scandal at NIH with article in L.A. Times that shows that high NIH
officials including Steve Katz, John Gallin and others have made hundreds of thousands
of dollars consulting for pharmaceutical and biotech companies.
Dec. 8-10, 2003 – Much media attention regarding the Fujian strain of influenza and the
early indications of a bad season with deaths of children in Colorado and elsewhere.
Vaccine has run out and people are panicking.  83 million doses distributed.  I have
already been and will be on CNN multiple times, MSNBC, CNBC, CBS, etc.
Dec. 13, 2003 – Saddam Hussein captured by US Army outside of Tikrit, Iraq!!
Released by Chairman Rand Paul
87Dec. 16, 2003 – Went to dinner reception at the home of Assistant Secretary of Defense
for Health Affairs William Winkenwerder in honor of Dr. Khudair Abbas, Health
Minister of Iraq.  Present among others were Kristen Silverberg (who spent time in Iraq –
see above regarding the books of HPIM-15 that I sent to Iraq), Ken Bernard, Surgeon
General Richard Carmona, Congressman Fred Upton,  etc.  Iraqs really want me to go to
Iraq for moral support of the Iraqi medical establishment and health system.  They were
all very appreciative of the books that I sent.  It is still very dangerous in Iraq, but I am
pursuing going with Secretary Thompson in Jan/Feb if possible.
Jan. 21, 2004 – Over the past month a number of issues have arisen.  There have been 3-
4 cases of SARS in China.  The Fujian strain of Influenza A escalated and now is
declining.  It may be that it was just a moderate year that peaked early and had people
worrying about it being a catastrophic year.  It may turn out that it was not that bad.  Big
worry is the appearance of H5N1 with 4-5 cases of jumping from chicken to man in Viet
Nam and massive chicken illnesses and deaths in Viet Nam, S. Korea and Japan.  We are
all busy in planning for a potential pandemic flu.  No transmissions from person to
person.
Also, we had been working on the document in response to the IOM report on
“dual use” microbes.  We (HSC, DHS, etc) established a Memorandum of agreement and
a Charter for the National Science Advisory Board for Biosecurity to advise the
Secretary, HHS, the Director, NIH, and the Secretaries of all of the Agencies involved in
the conduct and support of potential dual use research in the life sciences.  I presented the
MOA and the charter to the Deputies in the situation room in the White House.  It was
well received and will ultimately be signed by the Secretaries.
On the way out of the WH, I saw Margaret Spellings who said that the President
was talking about me today in that he wanted to be briefed by a group including me and
Julie Gerberding on prevention of HIV/AIDS by abstinence, be faithful and condoms
(ABC).
Jan. 21 – Feb. 25, 2004 – Very busy with many issues.  Two Congressional Hearings: 1)
House Gov. Ops – Pandemic Flu; 2) Full Approp (Senate) on BSE.  Also, much stress
with situation of outside activities.  I was “interviewed” by Alan Slobodin as was Andy
von Eschenbach, Francis Collins, Don Lindberg and ethics offices about “lecture
awards”.  Does not appear to be a problem for me, but they will likely force much greater
restrictions on outside activities.
White House (Gary Edson) has asked me to put together a proposal for
eradication of a few “neglected diseases” in developing countries similar to what I did for
the PEPFAR.
I was very persistent and finally got into TGT’s party to go to Iraq.  I feel almost
an obligation to do this for my country even though I must admit it is a bit scary. It
sounds corny, but it is the “Band of Brothers” feeling that I seem not to be able to get
away from.  I am a visible public servant and this is what I do. This is probably the most
dangerous situation I will have ever been in.  Will report details when I return.
Feb. 26, 2004 – Leave for Iraq!
Released by Chairman Rand Paul
88Feb. 26 – Mar. 1, 2004
Feb. 26 – Left for Amman, Jordan – Iraq on a Gulf Stream air force aircraft from
Andrews Air Force Base.  Trip purpose – “show the USA flag” in the context of health
issues and determine whether the USG/DHHS/NIH can do more in the Middle East.  On
the trip was Secretary Thompson (TGT), Andy von Eschenbach, Bill Steiger, Press-
Sanjay Gupta, Christy Feig  and Joe Farre (CNN) and Mark Sherman (AP); Security –
Jay Hodes.  In Amman/Iraq we met Charles Curie (Head, SAMSA), Howard Zucker, Dr.
David Smith (Humanitarian and Refugee Services), Andy Knapp and Mike Lonetto
(Security advance), Adm Van der Wagner (USPHS).
We landed in Marka Airfield in Amman and almost immediately changed planes
to an Air Force C-130 to Baghdad.  This would turn out to be one of the most memorable
days of my  life.  In the approach to Saddam Airport we did a sharp “corkscrew” landing
in which it felt like the plane flipped over.  The airforce guys explained that this is the
way that they avoid shoulder to air missiles as well as sporadic fire from AK 47s.  In
addition, the airport gets randomly mortared every day.  These are just  pockets of
insurgents that rarely hit targets, the real targets are the convoys of troops accompanying
cars (like ours) and isolated troops on patrol, as well as more recently, Iraqi police and
officials who are trying to rebuild the country.  We went from the airport to the “Green
Zone” (relatively safe with high security, despite the fact that rocket and mortar attacks
occur on almost a daily basis; these usually do not hit specific targets, but do cause
casualties) in Baghdad with several car-loads of Special Forces and DoD Criminal
Investigation Division (CID) security people and 4 Humvees full of Military police
manning M-4s and fixed machine guns.  The ride to Baghdad was thrilling and
frightening.  The alignment of the motorcade was that every time we passed a person(s)
walking along the highway or a parked car or truck, the special forces car would insert
themselves between the suspects and TGT's car (I was riding with TGT).  When we
passed an overpass or a car on our right, the Military police would aim their machine
guns up at the overpass and swing around the turret of the machine gun as we passed the
overhead.  The reason is that frequently insurgents drop grenades from overpasses and
run.  We passed cars driving with people or when cars pulled up alongside, the military
police and special forces would wave them over and point their guns directly at the
driver.  Reason – frequently, isolated cars drive by and shoot at the convoy.
First stop – meeting with Ambassador Paul (Jerry Bremer) in his office in the
imperial Palace formerly main palace of Saddam and now  headquarters of the Coalition
Provisional Authority (CPA). Tom Foley (Bremer’s Deputy) was not present, but we met
him later on in the trip).  Had great discussion of the difficulties in transition to the
governing council.  He made an interesting statement that democracy is a concept that is
foreign to the Iraqis.  They are taking a lot of time with their constitution  and agreeing
on their form of government since they seek “consensus”.  Democracy means that the
majority rules, and as we see in the USA, the minority has much power and the balance
can and does changes. The Iraqis are not used to the majority winning a vote since
historically, minorities get persecuted.  They need to understand that minorities are
minorities for a particular idea/law/regulation and that Sunnis, Shia’s and Kurds can be
minority, majority or both.  Sunnis and Shia’s can live together since there are many,
many mixed marriages.  Highly intellectual discussion.  Bremer is an impressive man.
Released by Chairman Rand Paul
89Also, met Jim Haveman who is the USA Health person (also impressive). Jim was with
us for most of the remainder of the trip in Iraq and Jordan.   He thanked me for the books
that I sent to Iraq from McGraw-Hill.
Had lunch at the home of MOH Khudair Abbas.  Present at the lunch  was Dr.
Ebrahim Al-Jafari, head of the Shiite Party and member of the Iraqi Governing  Council
(IGC)and Dr. Rajaa Khuzai a women OB/GYN physician and also member of the IGC.
Had a very stimulating conversation regarding Iraqi politics, the history of Iraq medicine
and how Iraq was the “jewel” of medical care and training in the 50s, 60s and early 70s.
When Saddam came into power, he diverted money to weapons and neglected health.
The system deteriorated and now it is terrible.  They want to restore it.  I also heard first
hand of the cruelty and true insanity of Saddam and his sons Uday and Qusai and how
they tortured and killed at will.  Many of the people at lunch lived in exile or remained in
Iraq, but had relatives who had been jailed, tortured or killed.
The defining experience of the day was the visit to IBN Sina Hospital which is the
combat (trauma) support hospital.  I had to constantly hold back tears.  Everyone carried
a weapon in the hospital, even the doctors and nurses performing procedures in the OR or
trauma rooms.  I say young kids (18-25 yo soldiers) with bullet wounds in the face.
Common wound is a cheek-through-cheek bullet that either kills the victim or goes right
through without hitting vital structures.  I am told that it is a common wound by snipers
since the troops wear body armor up to their neck and a helmet down to their eyes.  It is
one of the few exposed parts.  One such soldier was wheeled in as we were touring the
hospital. He had just been shot.  I say shattered legs, abdominal wounds and Iraqi citizens
shot in cross-fire and Iraqi insurgents getting x-rayed with a special forces person
pointing an M-4 at him in case he tried to escape.  I saw an Iraqi collaborator who was
helping the Special Forces in the North and another Iraqi came up to him when no one
was around and shot him in the back of the head.  The bullet miraculously went through
one posterior jaw and exited the face.  When taken to the hospital, he told the SF who the
attacker was that left him for dead and the SF had just left the hospital to “take care of
him”.  Many army physicians and nurses recognized me either from TV or more often
from Harrison’s. I ran into a young neurosurgeon – Major Koop who knew me from
HPIM.
Upon return to the airport via “ambush alley”, the 2 main Humvees of the 4 that
escorted us back had young women at the machine guns.  I inquired about this to our SF
driver and he said that as of this week, women soldiers have more confirmed kills than
men soldiers.  Upon take off, we had the same corkscrew maneuver, but this time 2
airmen were at each window with radio contact with the cockpit in case they saw puffs of
smoke or flashes indicating a shoulder to air missile or Ak-47 , at which point they would
alert the pilot to divert.
Landed in Amman; we did not sleep at the Rasheed Hotel in Baghdad since it was
recently attacked with rockets while Paul Wolfowitz was staying there. Had a marvelous
dinner at the home of the Jordanian MOH – Dr, Said. S. Darwazah.  Also present was our
team (minus the press), plus the US Ambassador to Jordan (Edward W. “Skip” Gnehm),
Dr. Samir Khleif, (NCI), Director of the King Hussein Cancer Center in Amman  and
Said’s brother Mazen and his father Samih.  We talked for hours about the complex
issues of Israel and Palestinians and Iraq and USA.  It is clear that they want to live in
peace with Israel, but they all feel that the USA in unfairly siding with Israel on not
Released by Chairman Rand Paul
90disallowing settlements.  Clearly, one of the most stimulating evenings I have spent.  The
Jordanians are truly wonderful people and very friendly and affectionate to Americans.
The food was incredibly good.
Feb. 28, 2004 – Visited the King Hussein Cancer Center in Amman. Dr. Samir Khleif
showed us around the modern facilities that have NIH-style telemedicine in real time.
Toured the pediatric cancer wards with patients who had ALL, squamous cell carcinoma
of ear and other tumors.  There is a Jordanian Program called Project Iraq in which
selected patients are chosen from sick Iraqis and are transferred to the Cancer Center for
treatment.  We say several Iraqi mothers with their sick children.  Had a nice warm
conversation with Princess Ghaida Salaam who is married to Prince Talal ibn Muhamed
(Nephew of the late King Hussein) and Princess Dina who is also married to the nephew
of the late king.  Both women were beautiful, articulate and spoke perfect English.
Princess Ghaida  is the Chair of the Board of the Center and she recognized me from TV
and said that she always wanted to meet me. I showed her my Harrison’s textbook in the
KHCC library.  She spent years in DC and graduated from Georgetown in the 1980s.
  After the tour we had lunch and discussed  the various programs. Afternoon was free
and we visited archeological ruins in Amman.
That evening, we had dinner at the home of Princess Ghaida.  This was a most
unusual evening; I was incredibly impressed by the Princess’s husband Royal Prince
Talal bin Muhamed.  He and Princess Ghaida both graduted from Georgetown in the
1980s. He gave me a wonderful history of the Muhamed family that descended from
King Faisal I, hundreds of years ago.  The family split and one line took over Jordan and
the other first went to Syria and then Iraq.  He knew Sadam and his sons since he was a
little boy and he feels that they were horrible sociopaths. He used to play with them as a
child during visits to Iraq and vice versa for Jordan.  Sadam gave him several guns as
gifts.  In Arab countries, a gift of a gun is a show of respect and affection. Talal was the
favorite of his uncle King Hussein and told many stories of his loving relationship with
the King.  He proudly showed me his incredible gun collection (rifles, shotguns, and
pistols).  He was in the Jordanian paratroopers, is a polo player and rides motorcycles.  I
feel that this person could really be my friend if circumstances allowed.  Very intellectal
and stimulating discussion at dinner regarding the war in Iraq and the Israel-Palastine
situation. He fees that the USA should have military rule in Iraq for 5 years before even
considering handing over the government to the Iraqis. He said that the Iraqis would
understand and respect this since what they want most is security.  He feels that a
situation similar to MacArthur and Japan would be desirable.  We discussed how this
would not be feasible politically in the USA, i.e. having a long-term occupation of Iraq.
He is afraid of the instability that would follow in Iraq and the region if we handed the
control of the government over to a governing council (which he feels is made up of
some good people, but some people with no credibility such as Chalaby).  In addition, he
feels that the US military is so respected for their force and discipline, that this is the
reason why the Iraqis fled.  He stated that the Iraqis are a “fierce” and proud people and if
the UN or the Poles and Spanish took over the security, the Iraqis would chew them up
and anarchy would prevail.  He states that no Arab country wants the USA to leave any
time soon.
Released by Chairman Rand Paul
91Feb. 29, 2004 – Last day in Iraq…mostly in the red zone.  Some very exciting and
somewhat scary moments with the convoy getting caught in traffic in  another “ambush
alley” (narrow streets and high buildings where insurgents frequently shoot down on US
troops from roof-tops or windows). During several of these “stalls” in traffic, the special
forces, military police escorts and the CID (criminal investigation division) of the army
jumped out of the cars and ran alongside with their M-4s pointed a the roofs and
windows.  They also ran up to cars that were blocking traffic and pointed drawn pistols
and cocked M4s right into the cars to get people to move. Visited the MOH in the AM,
the Women’s clinic, had lunch with Iraqi health people.  This was all in the “red zone”
and the SF had sniper observers on the roofs of the buildings surrounding the facility that
we were visiting. We then left for the airport had a wonderful dinner at Baghdad airport
(Bob Hope Dining Hall)  with the troops of the 1st Armored Division, Military Police
Brigade, the First Cavalry, and the 101st Airborne.  Our troops are incredible, including
the women.  They are extremely well disciplined, polite, good looking and nice.  General
Scaparroti (Chief of Combat maneuvers) brought TGT and me into the “classified”
command room of the base and showed us how they track hostilities on a real time giant
computerized map screen.  Met an incredible woman  Major Rogers who was a beautiful,
articulate and smart, 35-ish deputy chief of intelligence for the command. Also met Col.
Flake who was the combat coordinator – one tough looking soldier.  Also met Major
(Doctor) John McGrath from the Medical Corps.  He knew me right away since his wife
is a physician (Allergist/Immunologist) and always talks about me.  He asked for and got
a picture of us together. Finally, we flew on Blackhawk helicoptors to Balad AFB to
catch a C-17 to Rhein-Main AFB in Germany. The trip on the Blackhawk was tense and
exciting.  I sat 2 feet from the machine gunner who was focusing on the ground looking
for flashes from small arms fire that happens all the time and usually misses the
helicoper.  As soon as they see a flash they immediately strafe the area with the M-50
machine gun.  We flew all in the dark to avoid detection.  We landed at Balad, stayed for
awhile and mixed it up with the troops and then flew to Rhein-Main AFB near Frankfurt.
From there we picked up the Gulfstream and flew back to Andrews AFB. We landed at
6:00 AM, March 1, 2004.
March 2-19, 2004 – Following the Iraq trip a number of relatively important issues have
arisen.  There is sweeping interest in the conflict of interest  arena with EZ forming a
Blue Ribbon Panel on Conflict of Interest chaired by Norman Augustine and Bruce
Alberts.  Also, the NIH Ethics Advisory Committee (NEAC) is now reviewing all out
side activity requests (as well as any already approved ongoing outside activities) for
high ranking NIH officials such as IC Directors, Deputies, Scientific Directors, Clinical
Directors, etc.  The NEAC is co-chaired by Raynard Kington and Michael Gottesman.
Happily they have approved my ongoing activities, including Harrison’s.
I met with the Blue Ribbon Panel and urged them to distinguish between outside
activities that could be conflictual such as consulting for drug companies and those that
are purely academic such as writing, editing, lecturing (not on your immediate work) and
awards.  They seem to “get it”.  I hope that their recommendations reflect this.  Several
investigations will come including GAO, IG, and a least 2 Congressional Committees.
Also, the Congress is developing a subliminal hostility towards NIH because of the prior
Released by Chairman Rand Paul
92doubling of the budget and because our advocates are still screaming for a 10% increase
in FY2005 instead of the 2.5% increase of the PB.  Sen. Dominici called the NIHers
“pigs” who are never satisfied.  Moral in quite low.
Good stuff going on with Gary Edson and the “neglected diseases” project.  He
really likes the proposal that I put together for Lymphatic Filariasis (LF) and leprosy and
malaria.  We are going through the exercise now of several meetings back and forth in
deciding what to have the POTUS propose to the G-8 meeting in June in Sea Island.
They want to have the POTUS show global leadership and urge the other G-8 countries
to put up money and get involved; however, since we are already doing so much, he
wants us to put up very little new money.  We will probably have to re-direct money – no
good deed goes unpunished.  Gary also wants me to explore the possibility of making the
HIV Vaccine Enterprise a possible proposal.  He had spoken to Patty Stonesifer and she
mentioned that Rick Klausner and I were working on this together.
John Kerry won Democratic nomination prior to convention and he and Bush are
going at it already.  The big issue is the terrorism that is going on in Iraq with foreign
Muslim extremists with ties to Al Quaeda almost daily blowing up mostly Iraqis and
some US soldiers.  Massive terrorist attack in Madrid a few days ago with bombs in
trains; hundreds killed.  Muslim extremists claim responsibility and say that they did it
because Spain has helped the USA in Iraq.  Incident occurred right before the Spanish
elections and resulted in overthrow of the Party that supported Bush.
March 24, 2004 – Had interesting and full day. Went to the National Defense University
at Fort McNair, Washington, D.C. to participate in the DHS exercise of a hypothetical
aerosolized anthrax attack on Chicago.  It was for the benefit of press leaders.  Secretary
Ridge, Susan Neely (Assist. Sec. for Public Affairs, DHS), Ed Thompson (CDC) were
the main players.  It was exciting and the press totally enjoyed it and got engaged in
active Qs and As.  Virtually all of the senior producers and correspondents of networks,
CNN, Fox, etc were present as were top print media.  Frank Sesno (CNN) moderated it
and Aaron Brown (CNN) was present.  Tom Ridge relied virtually totally on me to
answer medical questions.
Also, had meeting at PEPFAR Headquarters (2100 Pennsylvania Avenue, N.W.)
with Gary Edson, Randy Tobias, Robin Cleveland (OMB), Mark Dybul, Joe O’Neill and
Ambassador Lange to discuss how we can work an AIDS issue into the upcoming G-8
meeting in June at Sea Island, GA.  Gary and I proposed the possibility of highlighting
the HIV Vaccine Enterprise that Rick Klausner and I have been working on for the past
year.  It would cost the USG virtually no new money since the “Enterprise” is a virtual
organization that is proposing a strategic plan as described in our Science article.  The
POTUS can urge the G-8 countries to make a political commitment to make the
Enterprise work.
April 2, 2004 – White House (Situation Room) -  Had meeting today as a culmination of
a series of PCC meetings related to preparedness against pandemic influenza.  We have
been working with DHS, the VP’s office and DHHS to develop a white paper of needs
Released by Chairman Rand Paul
93and plans.  Today we brought it to the PCC + deputies (Claude Allen of DHHS).
Meeting was chaired by Richard Falkenrath.  Present were several WH and departmental
people including Kristen Silverberg, Ken Bernard, Carol Kuntz, Bill Winkenwerder,
Stewart Simonson, Allen Gilbert.  We came to a good understanding of what we are
ultimately going to put before the full deputies and ultimately the Principals.
April 5, 2004 – White House (West Wing) – Met with Gary Edson. Attending were
Carol Thompson, David Nelson and Gary’s assistant Martina Strong.  Discussed the G-8
issue regarding Gary’s concern that the other countries will bring up the issue of generics
and PEPFAR, i.e. the false impression that we (USG) are against generics , particularly
the generic fixed dose combination of D4T, 3TC and nevirapine.  Gary does not want the
POTUS to be embarrassed if others blind side him with this.  The PEPFAR people
(Tobias et al) should have straightened this out at a recent (March 29-30) meeting in
Botswana.  There was a debate about WHO “pre-qualification” of these drugs and our
concern about the criteria and data upon which these drugs were pre-qualified.  Also, we
discussed the issue of the POTUS proposing an endorsement of the HIV Vaccine
Enterprise as our AIDS proposal for the G-8 meeting in June at Sea Island, GA.  We will
work with Gates (Patty Stonesifer) to endorse this, but the Gates Foundation is going to
want us to promise even more money for an AIDS vaccine.  Note that we are already
spending>$500 million, vastly more than all other groups put together.  Gary will re-
write the POTUS’s G-8 proposal regarding the Enterprise and run it by me, Kristen
Silverberg, Secretary Thompson, Amb. Tobias before we launch it to the G-8.
April 6, 2004 – White House (EEOB) – Met with Kristen Silverberg, Robin Cleveland,
Randy Tobias, Mark Dybul, Alan Gilbert, Press person from WH (?name, a woman), Joe
O’Neill, and others to discuss issue of the bad press we are getting regarding the
misperception that the USG and PEPFAR will not buy generics, particularly the fixed
dose combination (FDC) of D4T, 3TC and nevirapine that CIPLA and Ranbaxy are
selling.  Decision was made to have Randy Tobias write and Op-Ed for The NY Times or
the Washington Post (I will review it for him) and then have me and Randy as necessary
do the TV circuit to get the truth out , i.e. that we will buy any drugs , even generics, so
long as they are of high quality (safe and effective) and the lowest possible price.
April 6-12, 2004 – Not much opportunity to implement issue above on April 6 because
the entire Press is consumed with the deteriorating conditions in Iraq.  Major insurgencies
by both Sunnis (Fallujah) and Shiites (Baghdad) against American troops.  Several US
troops are getting killed each day and insurgents have resorted to kidnapping civilians
from other countries who are working in Iraq, i.e. Japanese, Australians, UK, Chinese,
etc.  Bad situation that is getting worse.
April 13, 2004 – White House (West Wing) – 2 meetings.  First regarding the issue of
the HIV Vaccine Enterprise and whether we should make this an initiative for the
POTUS to present at the upcoming G-8 Summit in Sea Island, GA.  Present was Kristen
Silverberg, Martina Strong (Gary Edson’s assistant), Joe O’Neill, Carol Thompson.  I
presented the idea to Kristen and explained what Gary and I had been working on for the
past several weeks. I explained how we wanted the POTUS to challenge the G-8 to
Released by Chairman Rand Paul
94endorse and support the enterprise.  The USG is already investing for FY-04 about $488
million while the entire world’s contribution (including the USG) is about $600 to $640
million (these non-USG numbers are estimates.  Hence, most of the action is us. She
liked the idea and wanted to pursue it.  She said that it would be a home run if we could
spice it up with some new money.  She mentioned about $100 million.  I brought up that
the usual scenario would be that NIH would have to absorb this “new” money since there
really is no new money.  Kristen feels that if anyone can squeeze new money out of Josh
Bolten, it is me.  She is going to bring the issue up to Josh.
The second meeting was with Kristen, Joe O’Neill, Carole Thompson, Mark
Dybul, Randy Tobias, Jenday Fraser (new US Ambassador to South Africa).  Meeting
took place in Margaret Spellings office since it is one of the larger offices.  Margaret was
not there.  Discussion was regarding the options of how to address the FDC/generics
situation in the context of the PEPFAR.  We discussed a number of options.  Our goal is
to get the lowest possible price for drugs that are clearly safe and effective.  Big issue
with FDA since they clearly will not approve a drug based only on “pre-qualification” by
WHO.  There is much misunderstanding (see above) about the USG supposedly blocking
generics since we are in the pocket of PHARMA.  This is nonsense since we are
concerned that we will be buying drugs that are not even generics; they are “knock-offs”
from branded drugs.  I like the option of pressuring our drug companies to put 3 drugs in
a blister-pack (would take 1 month for the FDA to approve) to avoid the issue of
potentially low quality Faces.  Other good option is to work with the FDA to speed
approval (probably take 1 year since you would have to do some pharmacokinetics and
bioavailability studies first) of FDCs contained the branded drugs.  Simultaneous option
would be to ask the South African Medicine Control Council (their FDA) to regulate the
knock-off FDCs and to only buy it if they approve them.  This would be Africans making
decisions for Africans.  The only problem is that if they reject the drugs, it might look
like a typical erratic South African move, i.e. Mbeki and Shabalala Misemang are
notoriously weird.  Alternatively, if they accept the drugs with scrutinizing them and they
are no good, we would be buying bad drugs.
April 14, 2004 – White House meeting (EEOB 476) with Gary Edson, Rick Klausner,
Rachel Ingram (Gates) and David Lane (Gates), Martina Strong, Carol Thompson to
discuss the role of the Gates Foundation in the HIV Vaccine Enterprise.  Rick presented
the same case as I did and said that Gates would be willing to invest $100 million this
year and that the whole project would probably need $400 million per year for 10 years.
He wanted the USG to try to put in more money.  Gary was concerned about the fact that
we have no new money, although he really likes the Enterprise concept.  After Rick left,
Gary and I discussed how much if any money would be feasible to invest as new money.
As opposed to just challenging the G-8 to join and endorse the process.  He wanted to
think about it more.  One of the issues that he brought up even when Rick was there was
the problem of doing something and then getting criticized the way that we have been
criticized about PEPFAR.
April 15-16, 2004 – Series of phone calls and e-mails involving Gary, Kristen and me.
Apparently, Kristen really likes the idea about putting some substance (new resources)
into the POTUS proposal to the G-8 and Garry asked me to cost out a real center a virtual
Released by Chairman Rand Paul
95center and also a vaccine production plant.  He sent it to Kristen who asked me for some
clarifications and now will run it up to Josh Bolten.  This may be a go if we can convince
Josh to get some new money.  I coasted a real center (with walls) at $55 million for
construction and start-up and $47 million for annual operations.  I costed a virtual center
as $15 million start up and $51 million annual operations.  Kristen asked me to brief Alex
Azar (General Counsel for HHS) to see if we need any special authority/legislation
(similar to BioShield) to make this work more quickly and smoother.  She will be out for
a week and then we will resume.  I handled these calls and e-mails while on a quick trip
to Chicago to give a talk at the Clinical Research 2004 meetings.  I spoke on Emerging
Infections.
April 19, 2004 – Extensive phone conversation with Josh Bolten (OMB Director), Jim
Capretta and Tom Reilly (OMB) regarding the details of my proposal for the “virtual”
center for HIV Vaccine as described above.  I described in detail the entire proposal to
Josh. Josh was very supportive.  Issue was where to get the $15 million start-up costs for
’05 and the $51 million yearly costs.  Josh indicated that he would figure out where to get
the money.  More than likely that we (NIAID) would have to absorb a portion of it.
April 20, 2004 – Had nice lunch with Jay Lefkowitz today at The Oval Room on
Connecticut Avenue.  Beautiful warm Spring day.  Jay just wanted to catch up on things
with me.  We discussed the PEPFAR and the issues associated with it; and the new G-8
proposal that I was working on with Gary Edson. Kristen Silverberg, and now Josh
Bolten.  Also talked about war in Iraq and the POTUS.  Jay also inquired about what I
want to do differently if anything.  I told him that I wanted to remain in public service
and the Secretary of HHS is a job that I would not strive for or promote myself for, but
would not refuse if asked. He is thoroughly enjoying his private sector life.   After lunch,
he invited a friend (Christine Carlisle Jones) to the table for coffee.  She is the CEO of a
company that is working on freeze preserving eggs from women who might be getting
chemo, and he wanted her to meet me.  Very attractive and intelligent woman in her 30s.
It was great to spend time with Jay.  He has become a good friend.
April 21, 2004 – Busy day!  Beautiful sunny day.Testified at my House Appropriations
Subcommittee (Chaired by Ralph Regula) in the AM , then rushed to brief Senate and
House Staff (at Dirksen 116) from the Homeland Security and Appropriations
Subcommittees on progress of Project Bioshield and its possible use to procure drugs for
pandemic influenza. Many people present such as Bettylou Taylor of Senate Majority
Appropriations, Craig Stevens of House Majority Appropriations and a variety of staffers
from Homeland Security Committees, the latter were as usual disdainful of DHS.  Bad
news relationships between DHS and their respective committees.  Also present were
Sally Stanfield of DHS (terrific person), Stewart Simonson, Michael        (WH Legisl),
Tom Reilly of OMB, Ken Bernard of WH Homeland Security Council
After meeting, Ken and I rushed to OSTP on 1801 Pennsylvania Ave to meet with
the Weapons of Mass Destruction Medical Countermeasures Subcommittee.  I am on the
Steering Committee of the National Science and Technology Committee (NSTC)
Subcommittee on WMD Medical Countermeasures (Chaired by Bill Winkenwerder
(DoD) and Phil Russell (HHS).  I rarely go to these meetings, but Ken Bernard wanted
Released by Chairman Rand Paul
96me to be there for discussion of 1)Anthrax countermeasure development plan and 2) DoD
development of butylcholinesterase (BC).  BC is unbelievable.  It is a naturally occurring
plasma product that neutralizes the effects of VX and Sarin gas. It binds to the
phosphogen cholinesterase inhibitors of the gas and protects animals from sarin and VX.
It has no toxic side effects.  Taly Bar-Shalom from OSTP presented the data.  The DoD
people wanted NIH to do Phase 1 clinical trials on the plasma derived product and to pay
for the development of the recombinant product since they “had no money”.  The Phase 1
trial would cost from $1 to 10 million depending on the design.  The development would
cost a few million $.  I got up and chastized the army Colonels (Joe Perla et al) and told
Bill Winkenwerder that I was astounded that they had a countermeasure for a known
threat (Tokyo subway) that is completely effective in animals (rats, hamsters) and totally
safe, and yet they say that they do not have any money to develop it.  Unbelievable!  In
some fairness to them, the DoD money for Medical issues is so compartmentalized, that it
is difficult for them to move $ from one silo to another.  They have no way near the
flexibility that NIH has.  In addition, Bill Winkenwerder, who is Asst Secretary of DoD
for Health, really has no power or jurisdiction and cannot commit resources at a meeting
like this.  He is a very good guy and promised me that he would find the money.  I
offered to share with them the effort and cost of a phase 1 trial.  In reality, if they drop the
ball on the clinical trial and development of recombinant product, I will pick it up.
On the way from the Rayburn to Dirksen building, I ran into Hillary Clinton on
the street and she gave me a big hug and kiss and we chatted for a few minutes (with her
Secret Service people looking puzzled) about AIDS, etc.
April 23, 2004 – Went to dinner over Dan and Marina Ein’s home on Kenmore Drive in
NW Washington.  Dinner was to bring together people in DC interested in bioterrorism
and press folks who cover this.  Present among others was Bob Malsam (Head of DC
Hospitals) Dan Lucey (Medical Officer of DC DOH), Ceci Connelly (Washington Post),
Mike Iskowitz (Newsweek), Jerry Hauer (Biodefense Center at GW) and several others.
Among topics that came up was the buzz around town of the recent intelligence that
another “big” terror attack will happen soon.  The weather was clearing or rain after a
major thunderstorm.  I had wanted to go to the St. Albans vs Jefferson County (WV)
High School baseball game, but it was cancelled because of rain.
April 28, 2004 – White House (West Wing) – Met in Kristen Silverberg’s office to
discuss the FDC issue (see above).  Much discussion regarding our approach to FDCs in
the PEPFAR program. At meeting were the usual group: Kristen, Mark Dybul, Joe
O’Neill, Mark McClellan, some FDA economists, Emit (FDA), Carol Thompson.
I spoke with Kristen by phone after the meeting about my chose vis-à-vis options.
April 28-29, 2004 – Gary Edson called me and said that he had a “disturbing”
conversation with Patty Stonsifer (Gates) in which she mentioned that the USG should
promise NEW resources for the Enterprise proposal to the G-8.  Gary asked (and I did)
call Rick Klausner to get his take.  He is comfortable with our proposal.  Gary is
concerned that Gates will be lukewarm about our proposal and we will have another
example of the POTUS trying to do something good and then getting criticized for not
doing enough.
Released by Chairman Rand Paul
97May 4, 2004 – White House (West Wing) – Me with Gary Edson and Patti Stonecifer
regarding the HIV Vaccine Enterprise and the upcoming G-8 meeting in Sea Island, GA.
We have come to an agreement that if the POTUS presenting the Enterprise proposal to
the G-8, Gates will soundly applaud the effort and work with us to get it going.  The USG
will not promise an new money over and above the $500+ million that we already spend
on HIV vaccine research (this is about 5/6 of the world’s total of $640 million).
However, we will challenge the other G-8 countries to endorse the Enterprise strategic
plan and align current and future resources with the plan.
May 12, 2004 – Big White House day!  The President visited the NIH for a “No Child
Left Behind – Read First” ceremony.  It was held at NIH since the NICHD had some
activities in this area.  Ceremony held in Natcher Auditorium.  I sat in second row and the
POTUS recognized me from the stage and greeted me individually noting that I was in
the audience.  After his talk, he came down to “work the rails” and chatted with me for
about a minute on International AIDS.  He mentioned that he had just met with the
Health Minister of Angola.  He was as usual very complementary to me.
In the afternoon had a meeting in the WH with Kristen Silverberg, Allan Gilbert,
Randy Tobias, Joe O’Neill, Mark McClellan, Lester Crawford and many others about
fixed dose combination ARVs (FDCs) and the PEPFAR.  We have developed a plan and
a roll-out strategy.
After the meeting, went to Indian Treaty Room and had a going away reception
for Richard Falkenrath of the Homeland Security Council (HSC).  Had nice chats with
John Gordon (chief of HSC), Tom Ridge, Josh Bolten, Carol Kuntz, Clay Johnson and
many others.
May 19, 2004 – Good day!  Project BioShield legislation passed the Semate by a 99-0
vote.  The White House asked me to attend a press conference with Sens. Frist, Gregg,
and Kennedy as well as Secretary Thompson at the Capitol.  We briefed the press and I
answered several questions. TGT called me the “father” of the BioShield Bill.
May 27, 2004 – Went to a nice retirement celebration at the White House (Indian Treaty
Room of EEOB) for Gen. John Gordon (Director of the Homeland Security Council).  I
have developed a very nice relationship with John over the past year or so and he was
very glad to see me there.  Attending were Andy Card, Condoleezza Rice, Karl Rove,
Harriet Meiers, among others.
Getting ready to go on June 8-10 to Savannah, GA for the G-8 conference at Sea
Island.  The White House (Gary Edson et al) wants me there to answer press questions
regarding the HIV Vaccine Enterprise Proposal that the President will make to the G-8.
Gary asked me to get Peter Piot (Director of UNAIDS) to write an editorial praising the
proposal at about the time that it is announced.  I am working on this.
June 2, 2004 – Testified before the House Commerce Committee on Science chaired by
Mr. Bilirakis for the NIH Priority Setting in anticipation of reauthorization of NIH.
Testified with Elias Z., Andy VonEschenbach and Nora Volkow.  Tough questions, but
Released by Chairman Rand Paul
98the Hearing went well.  Immediately went to brief an IOM Panel on Biodefense.  They
were very flattering of me and the work that we have done.
June 3, 2004 – Busy day.  Went to Ali’s Lower School Graduation and rushed to testify
at House Select Committee on Homeland Security chaired by Chris Cox with Jim Turner
as ranking minority.  Chris Hayes and Joe Barton were there.  Many tough questions
since the Presidential race is heating up and the Dems want to give the impression that
the Administration is not doing enough on Biodefense even though we have
accomplished a lot.  I did very well.
Immediately after the Hearing I rushed to DHHS and briefed Sec. Thompson on
the G-8 meeting and the HIV Vaccine Enterprise.  Then I rushed to the White House for a
meeting called in the West Wing by Kristen Silverberg on the POTUS proposal (maybe)
to facilitate vaccine development by addressing liability, intellectual property, tax
benefits, and monopoly issues.
After WH rushed to go to Jenny’s Sports Banquet.  She received MVP for the
Diving Team.
June 8-10, 2004 – Went to Savannah, GA (Sea Island) for the G8 Summit hosted by the
USA.  I was part of a White House Team that served as Presidential Surrogates to brief
the Press before, during and after the President’s proposals of initiatives to the G8 leaders
gathered in Sea Island (UK – Tony Blair, France – Jacques Chirac, Germany – Gerhard
Schroder, Italy - Berlusconi, Japan, Canada - , Russia - Putin, and USA). The other
surrogates on the Team were: Elliott Abrams (Special Assist. To the president and Senior
Director for Near-East and North African Affairs at NSC); Andrew Card (WH Chief of
Staff); John R. Bolton (Under Secretary of State, Arms Control and International
Security); James L. Connaughton (Chairman, Council on Environmental Quality); Glyn
T. Davies (G8 Political Director); Kristen Forbes (Member, Council of Economic
Advisors); Jendayi E. Fraser (Special Assistant to the president and Senior Director for
African Affairs at NSC); Robert Joseph (Special Assistant to the president and Senior
Director for Proliferation Strategy, Counterproliferation and Homeland Defense); Alan P.
Larson (Under Secretary of State, Economic, Business, and Agricultural Affairs);
Constance Berry Newman (Assistant Administrator for Africa of USAID); Randall
Quarles (Assistant Secretary of Treasury for International Affairs); Condoleezza Rice
(National Security Advisor to the President); Frances Fragos Townsend (Assistant to the
President and Homeland Security Advisor); Dan Bartlett (White House Communications
Director); Scott McClellan (Assistant to the president and White House Press Secretary);
Gordon Johndroe (Laura Bush’s Press Secretary); and Jim Wilkinson (Deputy National
Security Advisor for Communications at NSC).  My job was to brief the press at formal
and informal briefings on the Health Issues which were mainly the Global HIV Vaccine
Enterprise (see above), the Polio Eradication Initiative, and to a much lesser extent, the
Famine Initiative.  I also briefed on the progress of PEPFAR the Global Fund for AIDS,
Malaria and TB and the issues on Fixed Dose Combination (FDC) and co-packaged anti-
HIV drugs.
The weather was beautiful and we stayed at the Westin Resort Hotel on
Hutchinson Island in Savannah.  All I did was work and did not get off the compound.
The security to get on and off the compound was as tight as I have seen anywhere except
Released by Chairman Rand Paul
99for Iraq. The Press center was adjacent to the Hotel. I spent most of the time in the White
House press unit with White House staff led by Pamela Stevens, Paul Morrell, Jim
Wilkinson, Barry Bennett (Deputy of Communications, G8 Summit Planning
Organization, Colby Cooper, Dana Perino, M.C. Koch, Jana..?, Corey..? and others.
It was exciting to be there and I ran into virtually all of my reporter friends on the
White House Press Corps including among others, David Gregory, Terry Moran, Norah
O’Donnell, Ann Compton, Bill Plant, John Roberts.  I had a great interview with an AP
reporter Scott Lindlaw, whom I had not met before.  The initiatives were very well
received.  However, as I have seen before, unpredictable events shape everything.
Former President Ronald Reagan and died a few days before and the press was totally
saturated with Reagan history and funeral news to the point that the G8 issues were
literally pushed from the front page.  I appeared on TV only one time on CNN and that
was for an interview with Anderson Cooper on my impressions of Reagan’s legacy on
AIDS, particularly during the early years when he did not even mention AIDS publicly.  I
stated on camera that the criticism of this silence on the part of the activists was certainly
justified; however, the activists are being too harsh (Larry Kramer wrote a piece calling
him worse than Hitler) since many things occurred behind the scenes that were good.  For
Example he allowed me to go out and be proactive and speak on behalf of the gay
constituents.  Also, Surgeon General Koop was allowed to mail his report to every
household in the USA. I also got some press with interview in foreign TV such as VOA,
Al Jazeera, Canada National TV, BBC, etc.  Also, a few mentions of my briefings in
WSJ, and many papers that picked up the major AP story by Scott Lindlaw.  Otherwise,
there was much less press for the G8 in general and for me than would have occurred had
not Reagan died.
June 18, 2004 – Attended a farewell party at the White House for Gary Edson.  He is
leaving NSC to work in the campaign.  His main job will be to prepare the POTUS for
the debates with Kerry.  I was the only non-WH person at the reception that was hosted
by Condi Rice and Steve Hadley of NSC.  In her praising of Gary for his work, she
mentioned 2 accomplishments among many: 1) the millennium account, and 2) the
PEPFAR.  When she spoke of the PEPFAR, she caught my eye and said, “Oh Tony Fauci
is here; they were the team that did this.  Tony was the brains and Gary was the brawn”.
July 9, 2004  -  2 meetings in West Wing.  First was a top secret briefing of Fran
Townsend, the new Director of the Homeland Sceurity Council.  She replaced Gen. John
Gordon who retired in June (see above).  Present at the briefing were Ken Bernard, Bob
Kadlec, Larry Kerr, Kate Spitler (CIA) and some others.  Purpose was to brief Fran on
the experiments that were being proposed regarding genetically engineered monkeypox
virus to duplicate what was shown in the mousepox model where inserting the IL-4 gene
into mousepox made it lethal and elusive for both vaccine and therapy.  Debate was
whether to do experiments and whether to classify them.  Purpose of doing experiments
was to determine whether the mousepox work also applied to the monkeypox.  In
addition, if it did, then we needed to develop countermeasurs such as anti-IL-4 drugs.
Fran was extremely complimentary to me saying that above all people, she
wanted to know what my opinion was and she wanted me to explain the details and
implications of the experiments.
Released by Chairman Rand Paul
100Next meeting was in the office of Faryar Shirzad (replaced Gary Edson on NSC;
see above). Present was Martina Strong.  Purpose was to plan the Fall meeting of the G-8
Vaccine Enterprise as promised by the POTUS.  We discussed what the format of the
meeting should be and what level of representation from G-8 countries should be there.  I
suggested at least a top scientist from each country and then for formality, we should
have the Ministers of Health there after the strategic plan had been finalized.
July 11 – 16, 2004 – Went to the XV th International AIDS Conference in Bangkok. The
depth of misunderstanding about the PEPFAR and the reason why the PEPFAR wants
expedited approval by FDA of the “copy” generics that are being used before USA
money is used to buy them is huge.  The activists were out in full force disrupting Randy
Tobias’s speech with signs of “He’s Lying”.  Ultimately they let him speak, unlike the
situation in Barcelona in 2002.  There was an extraordinary amount of USA bashing by
activists, the liberal press and even by international figures such as Kofi Annan who
stated that the USA was not showing leadership because we were not giving more to the
Global Fund.  He seems to have selective amnesia regarding the PEPFAR’s $15 billion
program.  Chirac made a similar statement.  Issues that were particularly misunderstood
were: 1) why the USA was not giving billions to the Global Fund; 2) why we wanted to
have an expedited approval of copy generics before the PEPFAR paid for these drugs; 3)
Why the DHHS only allowed 50 people from HHS to attend the meeting.  Most people
claimed that it was because the activists booed TGT at Barcelona and because we were
upset that we were not controlling the agenda.  Before the meeting a group of far-right
Congressmen wrote to the organizers of the meeting saying that they condemned the
meeting since more faith-based organizations were not given prominent roles in the
meeting and because not enough emphasis was placed on abstinence. This made the USA
look real bad.  Stupidly, the DHHS restricted the numbers of meeting participants
generally without doing it by category and as it turned out, some scientists who were
already on the program had to cancel out.  Thus, the topic was this stupidity rather than
all of the good things that were happening.  The activists were more misinformed than I
have ever seen. They had no idea what they were talking about.  All they wanted to do
was condemn the Bush Administration.  Bush asked the FDA (through Tobias, me,
Kristen Silverberg and others) to provide expedited review of these FDC products so that
we could have some guarantee of the safety and quality of the product before USA
taxpayer money paid for it.(see above).  This was the correct thing to do.  Can one
imagine if we tried to give drug to Africans by a process that was “not good enough for
Americans””  We would all get killed by Congressional Committees and activists, some
of which are the very ones who are crying for generic drugs right now. By the way, the
approved drugs are now available for hundreds, not thousands of dollars in Africa.  The
claim of the generics companies that the drugs are available for $140 does not take into
account that it cost much more for shipping, storage, etc. and so the real price is not that
far away from the brand price.  Furthermore, no one is going without drug since it is not
the generics versus nothing.  The PEPFAR is buying the brand name drugs and
distributing them.  The response was that the administration is in bed with PHARMA
since we do not want to allow generics for fear of PHARMA losing money.  The generics
are “pre-qualified” by the WHO.  However, the WHO is not a regulatory agency.  The
FDA and Tobias and I pleaded that the generics companies submit the applications and
Released by Chairman Rand Paul
101give the FDA a chance to show that they could give an expedited review.  We were
asking for clinical data that Medicines Sans Frontiers already has and has published, plus
biochemical equivalency and pharmacokinetic data and plant inspection, all of which are
real easy to get.  However, no generic company has thus submitted applications.  They
say that they do not have to since WHO has prequalified them. The real reason is that
they are afraid that the FDA will actually find that the product may not be good.  I think
the product likely is fine, but the mistrust on the part of the rest of the world for FDA and
the USA is palpable.  This likely relates to the situation in Iraq. The other source of
contention is the situation of Global Fund versus PEPFAR.  I took great issue with the
incredibly inappropriate public statement by Kofi Annan about the lack of USA
Leadership in Global AIDS (Kofi, did you forget your leadership on the Rwanda
genocide??). I tactfully blasted him and this concept on BBC radio and TV and CNN. I
was quite discouraged by this Conference.  The science was irrelevant although my
Special Lecture on HIV Pathogenesis went very well and was extremely well-received.
A major issue is that the USA is doing some stupid things like allowing the restriction of
numbers of scientists at the meeting and by having the far-right people act like they are
representing the USA.  However, this time, the activists and the international community
are even worse.  They are totally misinformed about what is really going on, but they are
louder than ever.  This in turn feeds the far-right and it becomes a vicious cycle.

The following is a Washington Post article that summarizes the situation very well:
Subject: [HEALTHGAP] WashPost: AIDS Activists Misfiring
AIDS Activists Misfiring
By Sebastian Mallaby
Monday, July 19, 2004; Page A17
In the past few years, global AIDS activists have worked miracles. They have shaken rich
governments awake, causing international AIDS funding to rise 15-fold. They have
beaten back big pharma's jihad against cheap, non-brand medicines, creating an
opportunity to treat millions of people in poor countries. But the activists, or at least some
of them, are in danger of tipping from heroism into shrill anti-Americanism. The sound
bites from last week's AIDS conference in Bangkok were straight out of a Michael Moore
movie.
Inconveniently for those who enjoy stereotypes, the Bush administration is far and away
the leader in the global AIDS fight. This year the United States will spend $2.4 billion on
the pandemic, nearly twice as much as all other donor governments combined; attacking
the Bush team for indifference to AIDS is like attacking it for inadequate defense
spending. But when Randall Tobias, the U.S. global AIDS coordinator, addressed the
Bangkok gathering last week, he had to endure 10 minutes of furious heckling before he
could get a word in edgewise.
Released by Chairman Rand Paul
102What triggers this hostility? The activists' first complaint is that U.S. AIDS spending will
finance programs to promote sexual abstinence and fidelity. Never mind that only 7
percent of the money will be spent this way; the abstinence agenda is derided as some
kind of kooky anti-scientific plot cooked up by President Bush's evangelical supporters.
Yet the plotters actually include very un-evangelical people such as Edward Green, a
Harvard medical anthropologist (and liberal Democrat) who's written a book on AIDS
prevention. Green has shown how Uganda's success in cutting HIV infection rates from
21 percent to 6 percent depended crucially on teaching abstinence. In the first half of the
1990s, the number of young Ugandans engaging in premarital sex plummeted; by 1995,
fully 95 percent of Ugandans reported that they were either abstaining or monogamous.
Elsewhere in Africa, experience also supports the Bush administration's desire to make
abstinence and fidelity part of its prevention strategy. The evidence from Botswana,
South Africa, Kenya and Zimbabwe suggests that there's no clear link between the
availability of condoms and reduced HIV
rates: All four countries have plenty of condoms yet plenty of infection. Meanwhile in
South Africa, the single most promising development is that reported rates of teenage
sexual activity have fallen for three years straight, disproving the notion that there's no
point in telling youths to change their behavior. In sum, it is not the Bush administration
that is ignoring the evidence. It is Bush's critics.
The activists' second complaint about the U.S. AIDS program is that it is hostile to
generic medicines. Until recently, this was true: Perhaps because of its ties to the big
pharmaceutical companies that sell patented drugs, the administration has been
scandalously slow to allow cheaper generic copies to be used in its programs. But in May
the Bush team finally announced that generics were okay, subject only to a six-week
review by the Food and Drug Administration to determine safety and efficacy.
The activists do not believe the FDA's change is for real, and their suspicions are
reinforced by Cipla, a leading Indian producer of generic AIDS drugs. Cipla's charming
joint managing director, Amar Lulla, explains to anyone who calls that he would love to
get his drugs approved for distribution in U.S.-financed programs in the poor world but
that the Bush administration's fine print is cluttered with obstacles.
On close inspection, however, these obstacles aren't serious. For example, Cipla's best
known AIDS medicine is called Triomune; it combines three separate antiviral drugs in
one pill, simplifying treatment. Lulla says the FDA has not explained whether he needs to
demonstrate the safety of combining the drugs this way, in which case Cipla would have
to conduct prohibitively expensive clinical trials. But if you go to
www.fda.gov/oc/initiatives/hiv/hivguidance.html, you'll find the explanation that Lulla
says he's waiting for. Attachment B lists three-drug cocktails that the FDA already
accepts as safe, among them one combining stavudine, lamivudine and nevirapine, the
three constituents of Cipla's Triomune.
Cipla also says it worries that if it files an FDA application, it may be sued by U.S. patent
holders. But the FDA's rules allow Cipla to file a statement certifying that its pills are
Released by Chairman Rand Paul
103intended for sale outside the United States, a maneuver that would almost certainly
eliminate the risk of being sued for U.S. patent infringement.
None of this is to deny that the Bush administration panders to the religious right on some
issues, or that it's cozy with pharmaceutical lobbyists. After misrepresentations on issues
from tax policy to Iraq intelligence, the suspicion with which Team Bush is greeted is
partly of its own making. And of course some criticisms of the administration's AIDS
program remain fair, notably that it shortchanges multilateral efforts against the killer.
And yet the bottom line on the Bush administration's AIDS initiative is that it is huge and
serious. The AIDS activists at last week's conference, whose motives are doubtless
honorable as well, would do better to redirect their heckling to countries such as Japan
and South Korea, which give shockingly little to their cause. When you're fighting an
enemy that takes 8,000 lives a day, it pays to pick your targets wisely.
mallabys@washpost.com
July 19, 2004 – Appeared on the Jim Lehr Newshour defending the USA position on
PEPFAR.  Steve Lewis from the UN was my “opponent” and we duked it out over the
bilateral approach of PEPFAR versus the multilateral approach of the Global Fund.  I
said both are good and working.  He feels that the USA should put all of its money into
the Global Fund.  He also did not understand the need to have some sort of approval for
generic copy drugs (see above).  Everyone told me that I appeared cool and collected
while Steve was shrill.
July 21, 2004  -  Two visits to WH today.  The POTUS invited me to be at the signing
ceremony for the BioShield Legislation in the Rose garden.  I was asked to go up on the
stage for the photo with the POTUS and the VP as well as Tom Ridge, Congressmen
Chris Cox and Waxman, House Speaker Dennis Hastert, Senators Ted Kennedy, Bill
Frist among others.  Michael Allen of WH Legislative Affairs was my advocate to get me
on the platform.  The White House protocol women (?name) wanted Julie Gerberding on
the platform (even though she had nothing at all to do with BioShield) since there were
no women there and she bumped me.  Michael insisted and they compromised by putting
us both up there.  The POTUS, VP and Senators were very nice with me.  I now know all
of these people very well.
In the afternoon, I briefed Carol Kuntz.  Ernie Takafuji accompanied me.  Carol is
great, but she is going through one of her periodic periods of sadness and anxiety about
her CML even though she is in a crisp remission on Gleevec.  I intermittently give her
private psychotherapy and I did so that night.
July 22, 2004 – Testified with Secretary Thompson and Julie Gerberding to the Senate
Committee on Health, Education, Labor and Pensions (HELP) on Public Health
preparedness, surge capacity and medical countermeasures.  Present were Chairman Judd
Gregg, Ted Kennedy and Lamar Alexander.  It was a very friendly hearing and very
complimentary to me and the others.
Released by Chairman Rand Paul
104July 23, 2004 – West Wing – Had individual photo op with VP Cheney together with the
entire “team” that worked on BioShield.  Many people there: Stewart Simonson, carol
Kuntz, Scooter Libby, Sally Canfield (DHS) (she just announced that she is leaving Tom
Ridge and going to work for Speaker Hastert), Mark McClellan, Ken Bernard, Michael
Allen, Brenda Becker, Sharon…(Sen. Gregg’s staff), Noreen Hynes, Seth… (Noreen’s
husband), Vince Ventimiglia (Sen Gregg’s Committee Staff). I will provide full list later.
Very happy occasion.  Again, VP was very gracious towards me.
August 11, 2004 – Met at EEOB Room 283 with Carol Kuntz and Bruce Miller and
Dorothy….  to discuss tentative plans to determine whether IL-4 gene inserted into
monkeypox would have the same effect as IL-4 inserted into mousepox virus, i.e. it
would suppress the immune response enough to allow lethal disease in the animal.  This
relates to concerns that terrorists will genetically engineer variola with IL-4 and so over-
ride vaccination and cidofovir.  Carol wanted to know which of several options for
experiments I would favor.  A White Paper was drawn up by the Office of Homeland
Secrurity (Ken Bernard) with the various options.  Of note, I had previously briefed
Frances Townsend in the White House Situation Room a couple of weeks ago (not
recorded above) on the same topic.  I favor Option #3 which is to conduct the research on
IL-4-altered monkeypox in monkeys and do it as classified research.  However, we
should announce that we will be conducting such experiments so that people do not get
suspicious that we are totally hiding things.  We would keep the design, details and
results classified since if we found out that it did work in monkeys , but did not yet have a
countermeasure for it, then we would expose our vulnerabilities.
Sept. 1, 2004 – Had a interesting day.  Flew by helicopter from the Pentagon to Fort
Detrick to visit USAMRIID with Deputy Secretary of DoD Paul Wolfowitz, Bill
Winkenwerder, and a number of other DoD and DHS senior staff to hear presentations by
Gen Lester Martinez-Lopez and others regarding why the DoD should support the
planned new Biodefense Research Campus at Ft. Detrick.  The Army wanted me there
since they know that I am an articulate advocate of their cause.  The meeting went very
well and I finally got a chance to meet and intensively discuss with Wolfowitz.
September 13, 2004 – For the past few weeks, I have been involved in a number of
briefings of Carol Kuntz and Stewart Simonson regarding Biodefense and the concern
about the emergence of an H5N1 bird flu that has been smoldering in Asia (Thailand,
Viet Nam, China, Taiwan, etc) with jumping of cases from chickens to humans.
President Clinton had quadruple bypass surgery at Columbia-Presbyterian
Hospital related to unstable angina this past week.  I contacted Senator Clinton’s office to
get his private e-mail address to send him my personal best wishes.
Today, I had an official briefing at the White House for Carol Kuntz and Bruce
Miller (her deputy) on research plans and strategy for countermeasures for “Genetically
Engineered Microbes”.  The presentation was very well received.  Carol gave me a “red-
lined” copy of the Bioshield Legislation that was signed by President Bush and VP
Cheney as a special gift from them to me due to my work on the development and
passage of BioShield.
Released by Chairman Rand Paul
105Oct. 4, 2004 – Meeting in the Situation Room of the White House to brief Ken Rapuano
(Deputy to Fran Townsend) on the IL-4 – monkeypox experiment that is being proposed
as a classified experiment to be performed by DHS.  I presented the rationale behind the
experiment.  Also present were Carol Kuntz, Ken Bernard, Stewart Simonson, Maureen
McCarthy, Gerry Parker, et al.  Although NIAID will not perform these experiments,
Fran Townsend wanted to make sure that I did the briefing since she trusts me.  The plan
is for me to make the same presentation to Colin Powell and Donald Rumsfeld soon after
the election.
Oct. 5, 2004 – Historic day today with the UK regulatory agency suspending the license
of  Chiron to ship out their influenza vaccine to the USA because of issues related to the
inspection of the plant in Liverpool.  This is a huge issue for the USA since Chiron was
scheduled to supply about 46-48 million doses or about 50% of our yearly requirement of
100 million doses.  Only Aventis Pasteur  (50 millioin doses) and Medimmune (2 million
doses of Flumist) are available.  We heard about this abruptly this AM as we (Julie
gerberding and I) were getting ready to testify at  House Hearing on Thimerasol in
Influenza vaccines.
Oct. 6, 2004  - Trip to Duke to honor retirment of Ralph Snyderman as Chancellor.
White House conference call at the airport in Raleigh-Durham on way back regarding the
influenza vaccine issue.
Oct. 7, 2004 – Trip to Duke to honor the retirement of Ralph Snyderman.  Gave talk on
Emerging Infectious Diseases.  White House conference call on Influenza issue (see
above).  Incredible amount of media appearances: radio, TV, print.  As much as I have
ever done.
Oct. 8, 2004 – Big time Congressional Hearing on influenza vaccine problem before the
House Government Reform Committee.  I testified with Julie Gerberding and Lester
Crawford of FDA.  More media, White House Conference calls, and Jim Lehr NewsHour
to finish the day.
Oct. 9, 2004 – Front page story in the Washington Post saying that the UK regulatory
authorities told our FDA about the problem at the end of August with the implication that
the FDA failed to act in preparing for the shortage.  Acting FDA Commissioner Lester
Crawford explained on our regularly scheduled White House Conference Call that this is
misinformation.  As we (me, Julie and Les) have stated all along, Chiron kept reassuring
us that there was a problem with about 4 million does due to contamination with Serratia
marcescens.  Never did anyone say to FDA or CDC (nor did Rino Rapualli say to me)
that there was a serious enough problem to suspend licensure.  John Kerry came out with
ugly statement saying that the Administration is covering up.
Oct. 10, 2004 – Things still hot and heavy with the Chiron/influenza situation. Had
another White House conference call with Margaret Spellings, Alan Gilbert, Phil Hall,
Harriet Miers (Deputy Chief-of-Staff), Jon Burks, Ken Bernard, Trent Duffy, Scott
Released by Chairman Rand Paul
106Whitaker, Julie gerberding, Les Crawford and Bruce Gellin.  Also more media
appearances for me.
Oct. 12, 2004 – Important White House meeting at 1:00 PM in Roosevelt Room on the
Flu situation.  Chaired by Margaret Spellings and Harriet Miers.  Also present were Fran
Townsend (HSC), Joel Kaplan (OMB), Jack Marburger (OSTP), Alan Gilbert, Hobbs,
Leitch, Montgomery, Jackson, Amit Sachdev (FDA), Stewart Simonson, Julie
Gerberding, Suzy DeFrancis (WH Communications), McGrath.  We  discussed strategies
to handle problems.  I gave a background of flu vaccines in general together with the
nature of the current problem.  Julie gave the plan for trying to get equitable distribution
of the remaining doses from Aventis Pasteur that have not already been distributed.  The
issue of the conflict in statements from our FDA and the British regulatory authorities
(MHRA).  They said they told the FDA about the seriousness of the problem weeks ago
and our FDA says no.  Our FDA is correct since I was hearing the same thing.  We
believe the UK people have over-reacted and now it has caused a mess here in the USA
and they are embarrassed to retract.  Important point that I brought up and again called
Margaret Spellings about the evening of today was that John Kerry would likely try to
embarrass the President in the debate on Oct. 13 by saying that the FDA knew and
covered up and that he believes the Brits.  I suggested to Margaret that the FDA come out
with a forceful statement BEFORE the debate declaring that the UK did not tell them
about the problem so that the President is not left hanging out there.  Margaret agrees and
they will do this on the morning of Oct. 13.
Oct. 13-14, 2004 – Multiple HHS and White House conference calls regarding the
influenza vaccine crisis.  Report from FDA’s Jesse Goodman who just returned from UK
is that the Liverpool plant  really did have some serious GMP problems and potential bio-
burden problems.  Our FDA agrees with the findings of UK regulators, but not
necessarily with their action.  However, it is too close a call for us to say that we would
have released the lots.  Therefore, we will publicly say that the lots from Chiron are
unusable.  We further discussed other issues about how we can get more vaccine from
AVP or from Canada or from anyone else.  If we go with Canadian vaccine, this would
have to be done by an IND since it is not licensed by FDA.  Most we can get is 2-3
million doses.  Even this is a logistic nightmare to do under an IND.
Present on Conference call with WH are Spellings, Silverberg, Miers, Dan
Bartlett, Trent Duffy (Deputy Press Assistant), Alan Gilbert, and HHS team of Julie,
Stewart, Les Crawford, Scott Whitaker, and me.
Oct. 15 – 18, 2004 – Situation getting very hot and heavy.  Kerry campaign trying to
make this a political issue saying that the shortage is President Bush’s fault.  I have been
on every major TV show multiple times talking about the issues and what people need to
do.  Multiple (daily) White House Conference Calls. Almost constant briefings and press
interactions.  Will need to go on a New England bus tour this weekend from DC up the
corridor to Boston and fly back.  Very intense, at least as much as with the anthrax
situation, mostly because the election is 2 weeks away.
Released by Chairman Rand Paul
107Oct 22-23, 2004 – Continued intensity of activity around the influenza vaccine shortage.
Daily White House Conference calls.  The DHHS team has broken up into several groups
to “tour” the country in a bus for outreach and education to health authorities, the general
public and the Press.  I was part of a tour that went from D.C. to Philadelphia to Trenton,
Newark, NYC, Hartford, Providence, Boston and back (Flew back from Boston).  Our
team was Claude Allen, myself, Howard Zucker (Deputy Asst Secretary of Health), Bill
Hall (DHHS Public Affairs), Sarah Greirich (Claude’s assistant), Kate (?).  It went well.
This is becoming a serious political issue in that the Kerry Campaign is trying to paint the
Bush Administration as responsible for the Chiron mess.  President Bush in turn is
claiming that liability issues are the cause of Pharma not getting into the vaccine business
and that Kerry supports trial lawyers who are the problem (VP candidate Edwards is a
liability lawyer).
Oct. 25, 2004 – Went to LA to be Keynote Speaker at a USC conferenec on Multi-Sector
involvement in research (Government, Industry, Academia).  Afterwards I gave a press
conference with the Editorial Board of the LA Times.  The topic of influenza vaccine
dominated the conversation.
Oct. 26- Nov. 8, 2004 – Daily White House conference calls on influenza situation.
Trying to get additional doses from Aventis, Medimmune and foreign sources.
Bush re-elected.  Very good for me since the team stays in place.
Horrible tragedy – John La Montagne, my beloved friend, colleague and Deputy
Director of NIAID dies suddenly on Nov. 2 after disembarking from flight from DC to
Mexico City (his birthplace) on passport line in Mexico City.  He had a pulmonary
embolus, very likely from the flight with venous thrombosis.
Nov. 12, 2004 – Meeting in Roosevelt Room of WH to discuss the plans for influenza
preparedness and for pandemic flu plans.  Major points are what we have been discussing
for the past few weeks about providing incentives for PHARMA to get involved and stay
in flu vaccine field.  We (DHHS team) are proposing back end guaranteed purchases for
overflow doses; liability protection, tax breaks, research to develop cell culture based and
recombinant DNA approaches to replace egg-based approaches; advanced purchase and
stockpiling of vaccine for children.  TGT presented and I filled in.  Present were:  Karl
Rove, Josh Bolton, Margaret Spellings, Kristen Silverberg, Alex Azar, Scott Whitaker,
Grant Dixton, David  Leitch, Harriet Miers, Alan Gilbert, Carol Kuntz and others.
Nov. 17, 2004 – House Hearing of Government Reform Committee on the flu crisis
today.  I testified together with Julie Gerberding and Lester Crawford (Acting FDA
Commisioner).  Mostly they slammed FDA for not acting more aggressively to monitor
the Chiron plant and pick up contamination.
Bush shuffling around his Cabinet following election victory.  People that I know
are moving out of positions where it was good to have a contact for me and into positions
where it is also good to have a contact.  Condi Rice to State, Margaret Spellings to
Education.  Much rumor about TGT and whether he will go to DHS or whether it will be
Fran Townsend if Tom Ridge leaves.
Released by Chairman Rand Paul
108Nov. 18, 2004 – Hearing today before House Commerce and Energy Investigations.
Together with Julie and Les Crawford.
Nov. 19, 2004 – I arranged a meeting among Medimmune (Flumist), the FDA, and
Stewart Simonson to try to pursue ways to get broader approval and utilization of Flumist
for next year to make up for the anticipated shortages since Chiron will almost certainly
not be able to re-fill the gap by next year.  Present at the meeting were Medimmune CEO
David Mott,  President Jim Young, VP of Reg Affairs Peter Patriarca, CMO Edward
Connor, Sr. Director Scientific Affairs Kathleen Coelingh.  From FDA were Les
Crawford (Acting Comm) and Jesse Goodman (head of CBER).  Also, Stewart
Simonson, Bruce Gellin, Pamela McInnes, Ralph Tate.  I am trying to be the facilitator to
have FDA look at Medimmune data on 50 to 64 year old people sooner rather than later
so that Medimmune can produce an extra 10 million doses for next year.  They need
approval for this age group or else then cannot take the risk of making 10 million more
doses and not be able to sell them.
Nov. 30, 2004 – Memorial service hosted by me at Natcher Building at NIH for John La
Montagne.  I delivered Eulogy (see speeches file).  I am only starting to come to grips
with the intense feeling of grief and sorrow at having lost John.  I really liked him very
much.  He was such a fine human being.  Present at the Memorial Service were Secretary
Thompson, Margaret Spellings, Carol Kuntz, Stewart Simonson, Julie Gerberding, D.A.
Henderson and hundreds of other friends of John.  I have appointed Cliff Lane as the
Acting Deputy Director of NIAID.
 Dec. 3, 2004 – Secretary Thompson resigns and asks me to come down to the
Department as he makes his announcement.  He brought me into his office alone and with
both of us in tears he expressed his gratitude and admiration for my service to him, the
DHHS and the country.  I expressed my mutual feelings for him.
Below is his resignation statement:
Dear Friends,
This morning, I submitted to President Bush my resignation
as Secretary of Health and Human Services.
It was a difficult decision and one I did not make easily.
But after nearly 40 years of public service, it is time for
me and my family to move onto the next chapter in our life.
It has been my honor and privilege to serve President Bush
and the nation with each of you in this dynamic Department.
As I have often said, our 67,000-member family is home to
the finest employees in the federal government. When you
work at HHS, the greatest doctors, scientists and public servants in the world are your
coworkers. I am truly grateful for the opportunity to work with all of you in this noble
calling.
Released by Chairman Rand Paul
109I am extremely proud of the work we did together at
America's Department of Compassion. President Bush set
forth an ambitious agenda for our Department. And I love
a big challenge. Since the day I walked through the doors
of this building, we have worked tirelessly to better the health and well-being of the
American people and our neighbors throughout the world.
Thanks to your work,
        *       We delivered on our promise to modernize
        Medicare with prescription drug coverage - the most
        historic improvement to Medicare since it was created
        in 1965. Now seniors and the disabled will get
        substantial help paying for the modern medicines and
        preventive services that extend and enhance their lives.
        *       We're spending more in medical research than any
        time in our history. And the President opened the door
        to federal funding of groundbreaking stem cell research.
        *       We're investing in our long-neglected public
        health system, making our nation better prepared to
        fight disease or biological attacks. We're improving
        the safety of the food we eat and import.
        *       We're developing the new medicines and vaccines
        to protect our citizens from disease or bioterrorism.
        *       Our children are healthier than ever, with health
        coverage and immunization rates at record highs and
        childhood drug usage going down.
        *       We turned America's attention to disease
        prevention, motivating Americans to eat better and
        exercise more in order to improve their health and
        quality of life.
        *       And we're waging a bold new global fight against
        HIV/AIDS, committing an unprecedented $15 billion toward
        eradicating this scourge. This will be a jewel in the
        President's legacy - and our years at HHS.
Together, we also faced challenges that were unpredictable and unimaginable.
        *       HHS was among the first on the ground to care for
        New York City residents and assist in the aftermath of
        9/11.
        *       From the day I arrived, we spoke of the need to
        better prepare for bioterrorism, and together we helped
        this nation weather the first biological attack on its
        people with the anthrax letters.
        *       We expanded our cache of smallpox vaccine, so we
Released by Chairman Rand Paul
110        can now protect every man, woman in child if this vicious
        disease were to return.
        *       We protected America from SARS and we helped the
        world understand this mysterious disease so we could
        contain its spread.
        *       We're leading the world to prepare for a world flu
        pandemic and Avian flu.
        *       And, together with our public health partners, we
        have helped this nation manage an unexpected influenza
        vaccine shortage.
That is quite a record in four short years. You all should be proud.
And, best of all, we are working together more closely than ever before to better serve
American families. We truly are One Department - with the best and brightest working
together across agencies to solve our nation's toughest problems. And we truly are the
Department of Compassion.
I will miss you all more than you can ever know. I will
forever cherish the friendships I made here the last four years. And I will always be in
awe of the talent, dedication and drive of the people of the Department of Health and
Human Services.
Keep leading this nation forward. Keep putting the well-being of our people first. And
keep changing the status quo in search of a better way.
You will always be in my prayers and in my heart.
With gratitude and friendship,
Tommy G. Thompson
Dec. 20, 2004 – 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
Released by Chairman Rand Paul
111in 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
Released by Chairman Rand Paul
112found 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
Released by Chairman Rand Paul
113stating 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
Released by Chairman Rand Paul
114forest and Arenal Volcano.  Did zip wire rides over the canopies.  One of the most
exciting things that I have done.
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.
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.
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.
Released by Chairman Rand Paul
115May 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.
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 C-
SPAN 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.
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
Released by Chairman Rand Paul
116Cyanamide 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.
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.
Released by Chairman Rand Paul
117Reauthorization 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.
July 14-22, 2005 – Looks like the Reauthorization Bill is getting some opposition from
constituents; however, Barton is trying to ramrod it through.  Zerhouni testified at House
Hearing.  It is still unclear how specifically he orchestrated this.  My sense is that
Zerhouni inadvertently created this monster in that he declared the NIH “broken” when
he came in as Director.  All he wanted was a little more power and some money to “be
somebody”.  However, Barton seized on this to “be somebody” by radically changing the
NIH.  Zerhouni may now be left with unintended consequences of his early attempts at
getting a bit more power.
July 25 – 29, 2005 – One of the most extraordinary weeks that I have experiences
(see below)
July 25, 2005 – Briefed Secretary Leavitt on briefing that I will give tomorrow to VP
Cheney on Biodefense countermeasure development.  Leavitt will accompany me to the
White House.  Real good team at the DHHS with Leavitt and Chief-of-Staff Rich
McKeown.  They are very good people.  NPR played the piece on “This I Believe” that I
had pre-taped for them.  I have received many verbal and e-mail comments from far and
wide about how moved people were by the piece.
July 26, 2005 – Briefed VP Cheney on Biodefense Countermeasure update for 1 hour.  I
was the primary and only briefer.  Present were Sec. Leavitt, Scooter Libby, Carol Kuntz,
Bruce Miller (Carol’s Deputy), Stewart Simonson.  We discussed progress since my last
briefing of the VP as well as some of the problems that we are facing with BioShield 1.
The Bill does not go as far as we had originally planned and the big companies are still
not incentivized enough.  We are left dealing with smaller companies like VaxGen,
Acambis, and others when we really want to engage the Merck’s and Glaxo-Smith
Kline’s.  The VP loved the briefing and resonated very well with me and the group.
While waiting in the upper West Wing Lobby to go into see the VP, I ran into
Sens. Ted Kennedy and John McCain. Kennedy and I have evolved into a very warm and
comfortable relationship over the years.  This is only the 3rd time that I had met McCain,
but I never really had a chance to talk to him before.  Had nice conversation about the
books that they are writing.  Ted is writing a book about his dog.
July 27, 2005 – Busy, Busy day.  Briefed VP Cheney again for 1 hour, this time with Sec
Leavitt on Pandemic Influenza.  Also, present were Carol Kuntz, Julie Gerberding,
Scooter Libby, Bruce Miller, Rajeev Venkayya,  and some others.  This is a prep for Sec.
Released by Chairman Rand Paul
118Leavitt’s upcoming briefing of the POTUS on July 29.  I will accompany him there also.
Carol was not too pleased with the briefing.  She confided in me that HHS does not seem
to be as prepared and definitive as she wants (excluding me, she said).  We (HHS team)
worked on the briefing afterwards to make it better.
   Also, appeared on Diane Rehm Show (Susan Page substituting for Diane) to discuss
Pandemic Flu.
July 28, 2005 – Even busier day today.  Spent 3 hours in White House Situation Room
with Julie Gerberding, Carol Kuntz, Kristen Silverberg, Bruce Gellin, Michael Jackson
(Deputy at DHS), Alex Azar, Tom Reilly (OMB), Joel Kaplan (OMB), Tevi Troy (NSC),
Ken….., and others to sharpen and focus the presentation of Sec. Leavitt for the POTUS
for the following day.  Then Julie and I testified before the House Committee on
Homeland Security, Subcommittee on Prevention of Nuclear and Biological Attack.
Chaired by John Linder, minority – Jim Langevin.  Also present were Chris Shays, Jane
Harmon, Ed Markey, Normal Dicks, Eleanor Holmes Norton, Donna Christensen, Bennie
Thompson, Ron Simmons, Bobby Jindal, Michael McCall, Jim Gibbons.  Good Hearing
for me, but only fair for John Vitko (DHS).  Also testifying were Julie Gerberding and
Gen. Eric Schoomaker.  One of  several Hearings on BioD.  Norton gave Julie some flack
(she always gets on Julie).
After the Hearing we (Julie and I)  went back to HHS and spent the next 2 hours
again briefing Sec. Leavitt for the POTUS briefing.  At the briefing were Leavitt, Rick
McKeown, Alex Azar, Natalie Kochnour, Bill Raub, Bruce Gellin, Stewart Simonson.
We are getting close to having it right.
July 29, 2005 – Another amazing day.  Spent a couple of hours together with Julie
Gerberding and Bruce Gellin at DHHS again pre-briefing Sec. Leavitt for the visit with
the POTUS.  Then went to White House and briefed the POTUS for 1 hour on Pandemic
Flu in the Roosevelt Room.  The POTUS was very engaged and went back and forth in
an animated and interested way with Julie and me and the Secretary.  He vowed to do
whatever is necessary to stop the onset of a Pandemic Influenza.  He turned to Josh
Bolten (OMB Director) and indicated that no expense should be spared.  He essentially
gave us a mandate to take care of this problem in no uncertain terms.
Present at the briefing were: VP Cheney, Karl Rove, John Bolten, Andy Card,
Harriet Meiers, Fran Townsend, Kristen Silverberg, Dan Bartlett, Scott McClellan, Mike
Chertoff, Tevi Troy, Julie Gerberding, Sec Leavitt, and others.
In the late afternoon, I showed around the NIH Michael Gerson who was with
Miss America Nicole Johnson Baker and her husband Scott Baker.  He was visiting the
NIH to look around and get a feel for the place.  We presented an HIV-infected IL-2
patient (Terry Brown) and discussed our IL-2 work.  Then we went across the street and
discussed malaria with Tom Wellums.  Mike Gerson is very interested in domestic AIDS.
He will get back to me to work on this since he wants to put an initiative of this sort into
the 2006 State of the Union Address.   Very successful meeting.
August 7, 2005 – Major Sunday news day with front page article in NY Times
predominantly quoting me) regarding the successful preliminary data from the NIAID-
funded H5N1 vaccine trial that showed safety and an immune response that would be
Released by Chairman Rand Paul
119predictive of protection.  This is obviously very good news in our comprehensive plan for
pandemic influenza preparedness.  This article in the Times kicked off a very positive
media frenzy with front page articles in virtually every newspaper (it was on the Times
web page the night before and so other papers picked it up) including Washington Post,
Baltimore Sun, Wall Street Journal (Web), AP, Reuters, etc, etc.  I appeared on ABC
Nightly News on Sunday night, NPR’s All Things Considered” on Sunday, CNN
American Morning on Monday AM.  Very positive “ink” weekend”.
August 17, 2005 – Briefed Secretary of State Condoleezza Rice at the State Dept. on the
threat of Pandemic influenza.  Also present were Sec/ Mike Leavitt, Rich McKeown, Bill
Steiger, Julie Gerberding, Bruce Gellin, Bill Raub, Dan Singer, and a few Assist. Secs in
DoS.  We gave Dr. Rice a primer on Pandemic flu and also discussed the international
implications, particularly related to the recent findings that migratory birds have brought
H5N1 to chicken flocks in Siberia, Russia, Mongolia, and Kazakhstan and flyways will
likely bring it to India and Europe.  She was very gracious and was glad to see me again
since I had briefed her a few times on HIV/AIDS and biodefense when she was at NSC
August 19-28, 2005 – Very productive meeting of editorial board of Harrison’s
Principles of internal Medicine (HPIM) – 17 and McGraw-Hill publishers at Spring
Creek Ranch in Jackson Hole, WY to plan the 17th Edition that will be published in 2008.
We returned there after our 1991 planning meeting for a prior edition.  I am the editor-in-
chief for the 17th and I picked Jackson Hole.  Great choice.  Beautiful weather and above
all, Bob and Colleen Grady have  a beautiful home there and our girls stayed with them
while Chris and I stayed at the Spring Creek Ranch.  Did fishing (caught several cutthroat
trout), hiking and just relaxing, although I worked every day (1 ½ day off) on the book.
Very frightening experience when Bob, Colleen, Chris and the girls took a (supposedly 6
hour) 12 mile hike on the Teton Crest trail.  A bit reckless on Colleen’s part in that we
started late (1:45 PM) and would have cut it close to get to destination by nightfall.  Trail
we difficult, but incredibly beautiful.  Unfortunately, we got lost (wrong turn) and lost >2
hours.  We hiked the last hour+ in the dark.  Alison was totally frightened.  We saw up
close several bull moose, mountain lion tracks and wolf tracks.  Danger was being
stranded in the woods overnight with temperatures going down to <40 F every night.  We
finally made it to the fire road and out by 9:25 PM.
 August 29, 2005 – Hurricane Katrina totally wrecked New Orleans, parts of Mississippi,
Alabama and Florida.  Levies caved in  New Orleans and Lake Pontchartrain poured into
New Orleans together with the river.  May be biggest natural disaster in USA history.
Thousands dead and stranded.  Hundreds of thousands of refugees living under terrible
conditions unable to be rescued.  Cliff Lane and I are planning a consulting arrangement
with IDSA and RCEs for infectious diseases.  More to come.
Bird flu activities continue with migratory birds now infected in Russia, Siberia,
Kazakhstan.  Europe worried.
Sept. 2, 2005 – Interesting situation.  Congressman Henry Waxman might use an old
document to help block the Bush nomination of John Roberts to the Supreme Court.  See
letter in attachment:
Released by Chairman Rand Paul
120
Released by Chairman Rand Paul
Released by Chairman Rand Paul
Released by Chairman Rand Paul
Released by Chairman Rand Paul
Released by Chairman Rand Paul
Released by Chairman Rand Paul
126
Sept .7, 2005 -  Still major disaster in New Orleans, Mississsippi, Alabama.  Likely
major repercussions about lack of ppreparedness on the part of State, local, and Federal
government in not heading warnings for years that the levees could not withstand a
category 4 or greater hurricane.  In fact, the levees caved in and N.O. was flooded 80%.
Sept. 9, 2005 – Briefed Pres. Bush today in the Roosevelt Room on update in Pandemic
Influenza Preparedness.  This was in follow-up of our previous meeting on July 29.  I was
with Sec. Leavitt, Julie Gerberding, Bruce Gellin.  On the White House side was the
POTUS, VP Cheney, Scooter Libby, Josh Bolten, Scott McClellan, Andy Card, Attorney
General Alfred Gonzales, Harriet Meiers, Robert Zoellig from DoS, and others.  The
POTUS was very engaging.  Half- jokingly he said that “Tony will have to fix this
problem for us with his research…”   Another good and productive briefing of the
POTUS.  Mention was made about not repeating the errors of Hurricane Katrina
response.
Sept. 14, 2005 – Briefed Carol Kuntz today on the

Summary:
Watcher-discovered document from paul-readingroom (2026.07.27_Diary-Prequel-.pdf), auto-indexed 2026-08-05.

Excerpt: hung up and  Released by Chairman Rand Paul 63mentioned this to Kristen Silverberg.  She knew nothing and immediately called Dan  Bartlett (WH Press Office).  I did not hear what they said; however, apparently what  happened is that the press confronted the WH with the Walters interview and the WH  caved in and admitted to the policy.  The crazy thing is that it has now hit the press, but  the WH will not let us talk about it since the President has not officially announced it.   We still do not really know what the policy will be nor when it will be announced.  More  later! Dec.12, 2002 – Much activity back and forth with the White House and the DHHS  regarding putting the finishing touches on the President’s Statement and the policy in  general.  In particular, Kristen Silverberg and…