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for Arts and Activism; Harriet Goldberg
won the 100 Women Award; Bill Jones won the Partner for Life Award; Barry Manilow
won the Silver Anniversary Community Service Award. He came with Suzanne Somers
who was wonderful with me and had been following my career for years. She said that
she knew all about me because she was a “doctor junky”. She has written several book
on Health for Women. Best was Morgan Fairchild who made sure that I was introduced
to everyone and also partook in my introduction on stage to receive the award. She really
was wonderful and friendly. The main introducer of me was Regan Hofmann (Editor of
POZ Magazine). She was beautiful and very nice. Donna Mills seemed a bit artificial
and had a forced smile, but everyone else was great.
Released by Chairman Rand Paul
196March 4, 2009 – Over the past few weeks the stock market continues to plunge with no
end in sight. The Dow is now at 6500 down from 14,000 in Oct., 2007. I have lost a
SUBSTANTIAL portion of my savings including the money form HPIM, Prizes, etc. –
well over $1 million. The retrospectoscope is always right, but the fact is, I always had
serious concerns about the vicissitudes of the market and always said that I would rather
not lose money that try to make it since my salary + book + prizes get me a lot of money.
John Katkish, who is a good man and conservative convinced me otherwise and here we
are – trapped since we cannot sell now since the losses would be phenomenal.
On the evening of March 4, I attended the annual Friends of Cancer Awards night
reception at the Hotel Monaco on 4th and F Street, N.W. Ellen Sigal and Marlene Malek
run this group and always invite me. The awardees were Steny Hoyer, Sen, Judd Gregg,
Lisa Paulsen of the Motion Picture Industry Foundation and Janet Woodcock of the FDA.
Usual DC glitterati of politics there. Steny was most gracious to me in accepting the
award and went on about what a great man and scientist I am and how we go back so
many years. He brought up (again) the story of how George H. W. Bush called me his
hero in the 1988 Presidential Debates. Also, had good conversation with Sen. Gregg and
told him that I respected his action of dropping out of contention for Secretary of
Commerce since he felt he could not go along with the Obama fiscal policy for the
“Bailout”. During the evening, go to have good conversations with Obama White House
people such as Dr. Kavita Patel who is assistant to Valerie Jarrett (closest person and
friend to the POTUS) and Neerha Tandem who formerly was with Hillary Clinton and is
now Special Assistant to the POTUS. Both said that they would get me to do some WH
briefings and briefings of the HHS Secretary designee – Gov. Kathleen Sibelius of
Kansas, whom I have never met. Zeke Emanuel was there and is establishing himself at
OMB as the Health policy person since there are few other people who know about
health.
March 5, 2009 – Zuckerman Fellows reception at the home of Beth and Ron Dozoretz –
3005 – 45th Street, N.W. (around the corner from my house). Clear, nice night. Usual
impressive event with Dave Gergon and Mort Zuckerman hosting the Fellows who are in
town for the week to get a glimpse of how USG is run. I will lecture to them tomorrow.
Met the usual crew from DC and had nice conversations: Tom Daschle – I expressed my
sorrow at his misfortune of having to drop out of contention for HHS secretary. Wolf
Blitzer (CNN), Nora O’Donnell (MSNBC), Gloria Borger (CNN), former Sec. Dan
Glickman, Gen. George Casey, Ambassador from Israel, etc. The young people there
was amazing: wounded vets of the Iraq war now going to Harvard Business School;
Physicians studying economics, health people in government schools. You feel good
about USA when you see these people.
March 7, 2009 – Very interesting dinner at Café Milano thrown by Catherine and Wayne
Reynolds for about 10 – 12 couples in the private room. Unseasonably warm (70 F) and
clear (stars and moon) night. Guests include Gen. George and Sheila Casey (Army
Chief-of-Staff). I sat between him and Marlene Malek (who was there with husband
Fred). Also in attendance: Don Graham and Dana Priest (Washington Post); Beth and
Ron Dozoretz; Francis Collins; Rick Atkinson (War Historian and best-selling author);
Released by Chairman Rand Paul
198died in Jan., 2009 of hep. B/Cirrhosis-related hepatoma. I was very involved with Brenda
in his terminal care and attempts to get him a liver transplant – it was too late for the
latter.
It was an cloudy, cool and damp day in SF. The ceremony was held in the Eureka
Community Center at 100 Collingwood, around the corner from the hub of the Castro
District – 18th Street and Castro. Big time déjà vu as I walked the streets of the Castro
since I got there a bit early (ceremony at 4:30 PM). I had flown in from DC in the AM
and took the red-eye back to DC that night. The streets of the Castro were crowded with
people bustling around. The usual crowd plus the fact that it was St. Patrick’s Day and
the parade had just ended. I recall back in the mid-80s when I visited the Castro several
times. It looked like the “walking dead” were in the street. So many cachectic people.
Today, everyone looks healthy, but the typical protease inhibitor and other drug “facies”
were evident with lose of facial fat pads.. You could tell that such a substantial
proportion of the people were infected, but now, in contrast to the 80s, they were doing
very well on drugs. Gave me a bittersweet feeling of how much we had accomplished
over these 27.5 years. The ceremony went well – packed with people from the Castro
who were so happy that I was there. I was the only government or health official there –
a shame since he was such a great man and contributed so much.
Fauci Eulogy for Martin Delaney
Eulogy for Martin Delaney
by
Anthony S. Fauci, M.D.
Director
National Institute of Allergy and Infectious Diseases
National Institutes of Health
March 14, 2009
San Francisco, CA
Released by Chairman Rand Paul
199Ladies and Gentlemen, friends of Marty Delaney,
I feel extremely honored and privileged to be here to celebrate the life of Marty
Delaney and to have been asked to express a few brief reflections about Marty and his
extraordinary work on behalf of people with and at risk for HIV/AIDS. I knew Marty
Delaney for 24 years. I first heard about him in early 1985 through some of my staff and
HIV researchers who were actually quite intimidated by him, mostly because he was, as
they said, ”making trouble for them” regarding the design of clinical trials. He certainly
was a big-time headache for the FDA. Actually, the problem for them was that Marty
was so smart, articulate and well-informed to the point that he knew more about
HIV/AIDS and the complexities of treatment access, patient education, and a sound
research agenda than some of them did. As they soon found out, he was correct most of
the time.
Now, confrontational and theatrical activism certainly has its place and has been
very effective in calling attention to important problems, notably HIV/AIDS. But
Marty’s brand of AIDS activism was somewhat different. As I recently described him,
he was analytical, well-informed, passionate, articulate, persistent, tough-minded,
gracious, transparent, fair, and above all a thoroughly decent human being. He did not
confront just for the sake of confrontation. I became very interested in learning more
about this person whom I had not yet met. And so I began to read what he had written
and I examined press reports about him and what he was doing in San Francisco and
throughout the country. Furthermore, when I found out that he was formerly a Jesuit
Seminarian, I decided I absolutely had to meet him personally since for better or worse I
had experienced 8 years of Jesuit education in high school and college. And so I
imagnied that we might have a lot in common
He beat me to the punch me by calling me up and saying that we needed to get
together to talk about patient access to experimental drugs within the context of highly
restrictive clinical trials. Although he was well-aware that I was not with the FDA, he
wanted my support in confronting the FDA about accelerated approval of drugs for HIV
and its opportunistic complications. We soon met and began one of the most
extraordinary relationships that I have ever had with a colleague and a peer. When we
both realized that we were fighting for the same thing, but we were just wearing different
uniforms, we developed a respect for one another that gradually morphed into a genuine
friendship that got stronger as the years went by. He never hesitated when he felt it
necessary and appropriate to nudge me, critique me, advise me, scold me, and point out
things that were not yet on my radar screen. He was an extraordinary source of
information regarding the community needs: Where was the pain? Where was the
anxiety? When was the time right to get out into the trenches and talk to specific people?
It was in this context that our collaboration was born, specifically in my speaking
publicly for the Parallel Track program despite the resistance on the part of the FDA and
many AIDS clinical researchers. Other activists, including Jim Eigo and his colleagues at
ACT-UP in New York, also were pushing for a parallel track of accessibility for drugs in
clinical trial. However, it was Marty who pleaded with me -- successfully -- to come to
San Francisco and see firsthand patients from the Castro who were suffering physically
and psychologically more than they should have been because the doors of access to
drugs were shut to them. He then arranged the Town Hall meeting where I was to speak
and as I was getting ready to go out on stage, he looked me in the eye and said, “Tony, do
Released by Chairman Rand Paul
202Anthony S. Fauci, MD
Director
National Institute of Allergy and Infectious Diseases
Building 31, Room 7A-03
31 Center Drive, MSC 2520
National Institutes of Health
Bethesda, MD 20892-2520
Phone: (301) 496-2263
FAX: (301) 496-4409
E-mail: [email protected]
The information in this e-mail and any of its attachments is confidential and may contain
sensitive information. It should not be used by anyone who is not the original intended
recipient. If you have received this e-mail in error please inform the sender and delete it
from your mailbox or any other storage devices. The National Institute of Allergy and
Infectious Diseases (NIAID) shall not accept liability for any statements made that are the
sender's own and not expressly made on behalf of the NIAID by one of its representatives.
From: Zuzu
Sent: Tuesday, March 17, 2009 1:07 AM
To: Fauci, Anthony (NIH/NIAID) [E]
Subject: Re: Favor
And on a completely unrelated note, Martin was so proud of the friendship he had with
you. I spoke at his retirement event and I wanted to make sure I mentioned things that
were important to him, so I sat down and talked to him about what he felt was most
important and what he was most proud of. He started by speaking generally, about the
quality of relationships he was able to build in different sectors - he was proud that
people would come to him seeking advice and equally proud that he would give it,
honestly, even when it was unpopular. But after a few minutes, he settled down to say he
was most proud of the relationship and the friendship that he'd built with you over these
years.
I mentioned briefly in my remarks that Martin stole my partner, Ed, for Sci Fi night every
Friday. I, however, was persona non grata because I wouldn't agree not to talk through
the programming. Ed said, however, "the only exception is when Tony called, then he'd
pause the program for upwards of a half hour and I'm glad I had my iPhone." There was
a place for you in his life that took precedent over nearly everything.
I know how present you were for him and when he had moments of clarity in those final
days I would tell him I was consulting with you, that you were speaking to his doctor,
etc., and he would smile and I know he felt like you were present with him and I know he
felt well attended to. I know he felt the presence of your friendship.
Martin's death is an unspeakable loss for me. He has been family to me and it breaks my
heart that my daughter will only know him through the stories that we tell and not the
Released by Chairman Rand Paul
203gestures of the way our lives intersect. Holidays won't be the same. I will miss our
walks, going to movies, having dinner, going to lunch... I will miss the projects we would
have launched and the fun we would have had and I will even miss how frustrated I
would get with him because of his stubborness. He could be terribly stubborn in the most
irrational ways.
He had seven vaccuum cleaners and there was little evidence he used any of them. He
had a garage full of car cleaning products, many (most) duplicates, and he paid to have
his car detailed. They were all unopened. (He said he "liked" buying them.. just in
case...) When we had dinner at his house, he'd create and re-create the recipes several
times before the actual evening and everything was perfect - he loved to cook. He would
say (often) that there was more evidence and likelihood) of alien life than the existance of
God - he was staunchly aetheist despite his sister's protestations. And he adored his sister
(though he specifically noted he wanted a non-religious service in San Francisco and for
the life of her she wasn't able to honor that... but I think he knew she couldn't and on
some level he'd be okay with that.) I would get more emails each week about alien
technology than I would about HIV/AIDS in recent years. There is nothing he would
want more than to be rocket launched into space with Gene Roddenberry and his wife...
It's all the little, seemingly inconsequential things, that I'll miss... anyways.
-Brenda
On Mon, Mar 16, 2009 at 9:28 PM, Zuzu wrote:
Tony,
Yes, March 21, sorry I mis-spoke. It was good to see you too, though I'm sorry it was
under these circumstance and also sorry it was so brief. I hope your travels home were
swift and otherwise uneventful.
Your advice is sage, as always. I'll have Dan's Heath Care Agent speak with his
physician.
Thanks again,
Brenda
On Mon, Mar 16, 2009 at 3:00 PM, Fauci, Anthony (NIH/NIAID) [E]
<[email protected]> wrote:
Brenda:
It was good to see you at Marty’s Memorial. With regard to Dan Cusik’s case, I assume you
mean that the UCSF transplant committee will discuss the case on March 21 (not February 21 –
in other words, they still have not decided). Having said that, it might be best if the committee
Released by Chairman Rand Paul
206Affairs Director), Dora Hughes (General Counsel to the Secretary, HHS), Nick ?. I
presented the proposal and they asked good questions and were very excited about it. We
will proceed with rolling it out after nailing down a few details.
While at the EEOB, I ran into Peter Orzag who greeted me as if we were friends. He
clearly knew who I was from seeing me down the hall. Good news that this WH at least
is up on what is going on in AIDS and health in general. Let us see how things evolve.
April 16, 2009 – My Op-Ed on “Policy Cocktail for HIV” appeared in Washington Post.
Got many nice comments. I am starting to get on the radar screen of the Obama people.
April 17-18, 2009 – First cases of an “untypeable”influenza noticed in California and
identified by CDC as a swine influenza of H1N1 type.
April 21, 2009 – Had lunch at the Oval Room across from Lafayette Park with Michael
Gerson (Washington Post, Council of Foreign relations) to catch up on some of the
projects that I am involved in re; Global Health issues. Mike was very influential in
helping me during the Bush 43 years with PEPFAR and the President’s Malaria Initiative.
I told him about my pushing for PrEP, Test and Treat, and Eradication of HIV (my new
“Big Three” for control of HIV). Nice time at lunch. He is a very, very sharp guy and
we have become good friends over the years – recall he invited me to private dinner with
George and Laura Bush at his home last year. I had turkey Club; Mike had asparagus
soup. Whether was sunny with threatening rain.
April 23-24, 2009 – First days of public awareness of the “swine flu” pandemic with the
“quadruple reassortant H1N1 influenza A. Around the clock conference calls and
meetings. In “battle mode” at HHS. I am handling everything for NIH, but there is
something strange regarding relationship with HHS (see below re: Jenny Backus.)
April 25-27, 2009 – Intense weekend with the potential pandemic evolving. Started in
Mexico and now person-to-person spread evolving in USA. At first only in TX and CA
and now beginning to spread throughout USA in small numbers that are growing.
Unclear why disease seems to be more severe in Mexico than in USA. Likely due to
larger undetected denominator in Mexico for some time and we are only seeing the
severe cases, whereas in USA with better surveillance, we see more mild cases. Also
spreading to Europe with several countries reporting cases, almost all related to trips to
Mexico or contact with people with Mexico exposure.
April 28, 2009 – Testified with Rich Besser (CDC) at Senate Committee on
Appropriations, Subcommittee on Labor, Health and Human Services, Education and
related Agencies with Tom Harkin as Chair. Went well. Great praise for me by Senators
despite the fact that the Department is only letting Rich Besser and CDC out on TV or
any media.
April 29, 2009 – Testified with Anne Schuchat (CDC) at the Senate HELP Committee
with Sherrod Brown as Chair. Again, great praise for me for being there during crises
Released by Chairman Rand Paul
207such as AIDS, SARS, Anthrax, and bird flu by Sen. Mikulski, Brown, Chris Dodd, etc.
hearing went very well.
April 30, 2009 – Real problems with the HHS public affairs people – Jenny Backus. It is
clear that I am being muzzled to speak to any major Press. Reasons unclear (see above).
Big issue today in that on the NBC Today Show, which Jenny reluctantly agreed to put
me on, the VP was quoted as saying that he would not want his family to go to any
crowded places like riding on a subway, in an airplane or in a crowded arena because of
the danger of people coughing on them and giving them the flu. I was on next and said
calmly that this is not the CDC Public Health policy and calmed the waters, etc. Jenny
had tried to have me call her 1 minute before I was on the air, but I did not see her e-mail.
After the show (in which everyone said I did a great job) we connected by phone and she
critiqued my answer to a question about the WHO increasing the phase of the potential
pandemic from 4 to 5 and asked me if I thought that it would go to 6. I said that based on
what the WHO was saying and the evolving nature of the epidemic, I would not be
surprised if they did boost it to 6. Jenny said I should not be making policy ahead of the
CDC and WHO – give me a break!. In any event, FOX National News wanted me today
and the subject of interview would surely be the VP’s misstatement. Surprisingly, Jenny
approved it and she said I should change the subject when they ask about the VP. She
sent me a statement from the VP’s office saying that when the VP was asked what he
would tell a family member if they planned a trip to Mexico, he would say not to fly and
that I should refer the press to his statement. The statement is a flat-out lie and they
wanted me to explain what the VP meant. I decided not to go on FOX and get caught in
that nonsense. Jenny is blocking me on all of the networks and cable shows that are good
and allowing me to do very little and so I am reaching the point where I do not want to be
involved with them.
April 30 – May 3, 2009 – Continued evolution of epidemic/pandemic with continued
real issues with Jenny Backus and me. She refuses to let me on TV and even yanked me
at last minute after agreeing that I would do Good Morning America today. I got to
studio and found out that overnight, she had substituted Rich Besser for me. The ABC
producers were horrified and apologetic. Also, Wolf Blitzer, Lou Dobbs, Bob Bazell and
others are getting pissed that they are not allowed to interview me. Even David Gregory
noted that it is surprising that I am not being seen on TV at all.
May 4-5, 2009 – Epidemic seems to be stabilizing and looking like a classical seasonal
flu , but out of season. Big issue is will it go underground over the summer and then re-
emerge with a vengeance next Fall and Winter just like in 1918.
May 6, 2009 – Testified before House Committee on Foreign Affairs, Subcommittee on
Africa and Global Health with Anne Schuchat and a USAID person.
May 6 – 16, 2009 – It is apparent that the epidemic is “stabilizing’ in that it is looking
like a typical seasonal flu, only out of season in the Northern Hemisphere. Only
exception is Mexico, where the apparent severity is not explained compared to the rest of
the world. It still could be an issue of the “denominator, i.e. there may be very many
Released by Chairman Rand Paul
208undetected mild cases in Mexico and so we are only seeing the severe cases and are
assuming that the disease is more sever in Mexico. As of May 15, there have been 4714
confirmed and probable case in the USA in 46 states with 173 hospitalizations and 5
deaths. Internationally, there have been 7520 confirmed cases in 34 countries. Clearly
this is different from the “swine flu” situation in 1976 where the virus infected 230
soldiers in Fort Dix, NJ with one death, but the infection never spread outside of Fort
Dix. This has important implications in the intense planning that is going on in HHS
regarding the production and administration of a vaccine. I am part of the “vaccine team”
at HHS made up of Bruce Gellin, Robin Robinson of HHS’s BARDA, me, Jesse
Goodman and Josh Scharfstein of FDA with input from CDC (Rich Besser et al.). We
are being very careful to uncouple the decisions about going ahead to produce the vaccine
for administration next Fall and Winter from the decision to actually administer the
vaccine next Fall and Winter. We will have to observe what the virus does this summer
here and in the Southern Hemisphere (their winter flu season). This drama is eerily
unfolding like the situation in 1976.
Thomas Frieden, Commissioner of NYC Dept. of Health, announced as Obama choice
for CDC Director. Interesting in that many people thought that the choice would be Rich
Besser because of the amazing public exposure he was getting, and the very nice job he
did, during the flu crisis (every major network every day). Just goes to show you – sic
transit glory or welcome to Washington!
May 27, 2009 – Went to Sons of Italy Awards Gala at the National Building Museum.
Sat next to VP Joe Biden and his granddaughter Naomi who goes to Sidwell Friends.
Also at table was his wife Jill (whose father is a Sicilian). Had nice conversations over
the evening with the VP – very amiable person with whom I have interacted several times
in the past re: anthrax, AIDS, SARS bird flu, etc. He was very complimentary to me
during his speech. He received the NELA Award for Leadership and Achievement in
Public Service (I received the NELA award for science in 1992). NELA = National
Education Leadership Award.
May 28 – June 2, 2009 – Continued activity working with HHS on flu preparedness.
Little press associated with this and Jenny Backus has not been heard from for weeks
since the press stuff has calmed down. Tom Freiden has been appointed as CDC Director
and so Richard Besser is completely out of the picture. He did a good job, but see above
regarding Jenny Backus. It is too bad, but my experience with Backus has seriously
soured me on HHS and everyone there. They seem to have no idea who I am and
certainly do not treat me with the reverence and respect that all other HHS people have
for the past 25 years. I do not think that Sebelius even knows my history and who I am.
June 3-4, 2009 – Received honorary Doctorate of Science at Harvard University in
Cambridge, MA. Wonderful honor. Other awardees were Steven Chu (Secretary of
Energy and the Commencement Speaker), Pedro Almodovar (Famous Spanish
filmmaker), author Joan Didion, religious historian Wendy Doniger, legal philosopher
Ronald Dworkin, anthropologist Sarah Hrdy, engineer Robert Langer, musician Wynton
Marsalis, and political scientist Sidney Verba. The night before the ceremonies (June 3)
Released by Chairman Rand Paul
209we had a festive banquet in Annenberg Hall. I remember when Chris and I first delivered
Jenny to Harvard for her 1st year, we walked through Annenberg Hall. It looks like the
great hall from Harry Potter books.
June 16-17, 2009 – Gave Keynote Address at the Pacific Health Summit in Seattle on TB
research. It went over extremely well. Many people said that the talk was “historic” and
“transforming”. I gave a passionate plea for pushing research on TB into the 21st Century
and making it transforming and not just incremental. Patty Conrad came with me to
Seattle to help out with the press and she enjoyed the trip greatly. Her first trip with me
in 2 years since she began working at NIAID.
June 22, 2009 – Back to the West Wing of the White House for the first time since the
Obama Administration began. Met in the Situation Room in meeting jointly run by
Laura Petrou (COS for Sec. Sebelius) and Heidi Avery (HSC) to discuss planning for
response (vaccine program) to H1N1 Swine flu.
June 30, 2009 – Had an interesting day of H1N1 flu “stuff”. Harvey Fineberg and I
constituted a panel that discussed the lesson of the Swine Flu affair in 1976 and its
relationship to what is going on today with the swine H1N1 2009. Sponsored by CSIS
(Center for Strategic and International Studies) and Kaiser with Steve Morrison and
Jennifer Kates presiding. Held in Room B339 in Rayburn Building. Standing room only
crowd. Went quite well.
Later in the afternoon, went to the Roosevelt Room of the White House to have a
similar discussion of lessons learned from 1976. Present were John Brennan (HSC), Sec.
Sebelius – (finally got a chance to chat with her and she congratulated me on my
honorary doctorate from Harvard a few weeks ago, Apparently, she was in the audience
at Commencement since her son graduated from the Business School); Jane Lute (Deputy
Sec. – DHS), Arne Duncan (Sec. Educ.), Peggy Hamburg (FDA), Ann Schuchat (CDC),
David Senser (former director of CDC who was fired in 1977), Harvey Fineberg, David
Matthews (Sec. HEW during 1976), David Hamburg, Walter Dowdle (old friend from
CDC), Peter Orszag (Director, OMB). President Obama joined the group for about 30
minutes. He clearly recognized me and greeted me warmly. The entire discussion went
from 3:30 to 5:10 PM. Warm, humid summer day in DC
July 2, 2009 – Another flu panel, this time at the AAAS at 12th and H Street, N.W.
Chaired by Harvey Fineberg. Other panelists were Anne Schuchat, Ken Bernard and Ken
Cole (US Navy). Good crowd, good discussion. War DC Summer day. Took taxi back
to NIH because of horrific delays on Metro’s Red Line related to tragic crash that
occurred last week where 9 people died.
July 9, 2009 – Participated as a major speaker at the “Flu Summit” held at NIH run by
HHS. Speakers were Sec. Sebelius, Janet Napolitano, Arne Duncan (Education), John
Brennan (HSC). Pres. Obama called in from the G-8 conference in L’Aquila, Italy with a
“Buon Giorno”. Much press at the conference. Still much activity going on. Weather
has been spectacular for July here in DC – very unusual – no humidity – cool in the AM.
Released by Chairman Rand Paul
210July 10, 2009 – Important meeting at the Pooks Hill Marriott to discuss the
transformation of our AIDS clinical trials network into a network that would be
“pluripotential” in that we would study a host of other diseases within the infrastructure,
i.e. TB, malaria, NTDs, flu, etc. There is obviously some resistance to this, but it is the
way to go.
Getting prepared for trip on July 16 – 22 to Cape Town for the IAS meeting where I
have several speaking roles (see below).
July 14, 2009 – Senator Carl Levin called me to ask my advice about the qualifications
and temperament of Tara O’Toole who has been nominated by Pres. Obama as an
Assistant Secretary in the Dept. of Homeland Security. He is Chair of the Senate
Homeland Security Committee responsible for approving her nomination. He has heard
concerns that she is somewhat of a zealot for Biodefense. I explained that I knew her and
that although she is a bit out there in thinking that there is Al Qaeda is every corner, she
still is quite competent and I would recommend that he approve her.
July 15, 2009 – Went with Patty Conrad to the book signing of D.A. Henderson’s book
on the history of smallpox eradication sponsored by Tommy Thompson of Aikin Gump
(his law firm). Tommy was very moved that I was there and introduced me when I came
in as “the person who discovered the AIDS virus” (ha!). When I corrected him he said,
“Well, Tony is the world’s greatest scientist”. Nice party. Some of Tommy’s old crew
was there: Stewart Simonson, Kevin Keane, Bill Pierce, Ladd Wiley, etc. Patty and I
went out to dinner at McCormick and Schmick’s on 19th Street afterwards.
July 16 - 21, 2009 Trip to Cape Town, South Africa to the International AIDS Society
(IAS) Conference on Pathogenesis, treatment and Prevention held at the Cape Town
Convention Center from Sunday, Sept. 19 to Wed, Sept 22. I left USA on Thursday, July
16 and arrived in Cape Town on Friday evening. Came DC with fuel stop at Dakar, then
to Johannesburg and on to cape Town. Exhausting 20 hour trip. Stayed at Cullinan Hotel
(Southern Sun)
On Saturday AM, July 18 gave the Keynote Address at the HIV/TB research Meeting at
the Desmond Tutu HIV Center of the University of cape Town. Lecture extremely well
received. I spoke of the same critical needs for TB (together with HIV) research that I
spoke about a few weeks before at the Pacific Health Summit in Seattle.
During the afternoon of July 18 drove down to Cape Point with Gray Handley. Clearly
Cape Town and the Western Cape is one of the most beautiful cities/areas in the world. It
look so much like the California coast from San Francisco down to Monterrey/Carmel.
Weather was stunningly beautiful with crisp clear skies and temperatures about 65-70.
This is most unusual at this time of years since this is SA’s winter.
In the evening of July 18, met with Julio Montaner (Pres. IAS) and co-chair of meeting
and Craig Mc Clure (Exec. Director of IAS) and Robin Gorna upcoming President of IAS
to discuss the possibility of holding the 2012 IAS meeting in Washington, D.C. They
Released by Chairman Rand Paul
211know that I am pushing to have the immigration ban lifted in time to make the decision to
have the meeting in DC. The ban has been lifted by law and is now in public comment
for final lifting by HHS. Also, they wanted me to help get Michelle Obama or the
POTUS to open the meeting in 2012.
Night of July 18, went to terrific dinner at a vineyard (Stillness Manor) hosted in my
honor by Linda-Gail Bekker. Linda Gail turned out to be fantastic as a major player in
the Cape Town (and all of SA) AIDS clinical trials network that NIAID supports. Met
with many South Africans to whom I told the story of PEPFAR. Only a few of them
actually knew how it started: John Hargrove, Robin Wood (Linda-Gail’s husband), Brian
Williams, Brian Brink, Des Martin, among others.
Sunday, July 19, took tour of Robben Island with Gray Handley. It was an incredibly
moving experience. The tour guide was a person who was imprisoned there for 5 ½
years. I saw Nelson Mandela’s cell, the quarry where he worked at hard labor and the
place where he planted his garden in the exercise courtyard of the prison. That evening, I
attended the opening ceremony of the IAS Conference.
Monday, July 20. Visited the Township of Gugulethu and participated in the launching
of the SAAVI102/HVTN 073 vaccine trial, which is a collaboration between the NIAID
and the South Africans on a DNA prime MVA boost vaccine. The South Africans
involved are Linda-Gail in CT and Glenda Gray in Durban (KwaZulu-Natal)
Collaboration also with VRC (Gary Nabel). Big ceremony at the launching with the
Minister of Science and technology (Dr. Pandor – woman), Anthony (Tony) Mbewu –
head of SA MRC, and Minister of Health Matsoaledi. I was very moved by the terrible
conditions of poverty in the Township of Gugulethu, but was equally impressed with
what was being accomplished by the roll-out of PEPFATR by Linda-Gail in this setting.
The extraordinary overlap and burden of disease with TB here and in Masiphumelele (see
below) was staggering. 30% of patients on the PEPFAR program were diagnosed and
were on treatment for TB when they entered program. Another 20% were diagnosed with
TB when they got there and another 10% developed TB during the time that they were
there.
In the early afternoon (1:00 PM I gave the Plenary Keynote at the meeting on the subject
of “US Sponsored HIV/AIDS Research and Prevention: Science and Policy”. Following
my talk was a talk by Eric Goosby, the new head of the Office of Global AIDS
Coordinator (OGAC). The session was devoted to AIDS science and policy in the new
Obama administration. My talk was very well received. I emphasized the science but
also stressed that the needle exchange ban would soon be over as would be the
immigration constraints, as would be abstinence only. I clearly stated that abstinence
only does not work. The crowd loved it.
That night had reception at the Consul-General’s (Alberta Mayberry) home (amazingly
beautiful view of CT from her terrace. All the implementers of PEPFAR were there from
USAID, CDC, and South Africans. I gave a short speech sincerely thanking them for
their work, and told them the story of PEPFAR. Eric Goosby also gave a speech
Released by Chairman Rand Paul
212Tuesday, July 21. I visited with Linda-Gail the Township of Masiphumelele. Again, I
was deeply moved by the poverty and physical nature of the place. Like Gugulethu, there
were small huts made of corrugated tin and cardboard thast were stuck to each other in a
“wall-to-wall” fashion for acres and acres. One could barely walk between the huts.
Again, the work that the South African health personnel were doing was inspiring. The
same numbers and problems with HIV and TB as in Gugulethu.
Tuesday night we flew back to DC and arrived early (6:00 AM) on Wednesday, July 22
July 22, 2009 – I rolled out the NIAID plan for the clinical trials of H1N1 vaccine to be
performed in the NIAID’s VTEUs. We will start in early August and do trials on healthy
adults, elderly, children to determine immediate safety, immunogenicity, dosage and
number of doses, and sequence of administration vis-à-vis seasonal flu vaccine. Much
press associated with this, i.e. appearances on ABC Evening News, CNN Situation room
with Wolf Blitzer, (on July 23) much print and radio (NPR, etc).
July 24, 25, 26, 2009 – Went to the Aspen Health Forum where I gave talks and served
on 4 panels: 1) Sex and health, 2) ARRA funds and how we spend them; 3) Swine flu;
and 4) Vaccines. My brief talks and panel appearances were extremely well received. I
mostly “ad-libed” and they loved it. Typical Aspen scene with many terrific people to
interact with: Tom Daschle, Walter Isaacson, Billy Tauzin, Mehmet Oz, Rick Stengel
(managing editor of Time), Jeff Kluger (senior editor of Time), Susan Denzler, Nancy
Synderman of MSNBC and a host of others. Excellent discussion, setting and exposure.
Beautiful place. Also had dinner at the Mr. and Mrs. Greenwald.
July 27, 2009 – Had a nice appearance on MSNBC with Dr. Nancy Snyderman
discussing H1N1 Swine flu. She was in Aspen (where I had just spent some time with
her) and I was in the studio at NIH.
July 28, 2009 – ACIP will recommend to CDC regarding vaccination program. I
appeared on ABC World News Tonight
July 29, 2009 – Big issue with release of data and paper in lancet showing that pregnant
women have significant increased risk of hospitalization and death from flu. I appear on
Good Morning America and MSNBC. On the latter, I spared with Arianna Huffington
who feels that we should not vaccinate children or pregnant women or even adults. Dr.
Nancy Snyderman (of MSNBC) was on program and complimented me and disagreed
with Arianna. CDC held press briefing after ACIP recommendations to first vaccinate
pregnant women, then caregivers of infants (<6 months old), then HCW, then young
people, then non-elderly with underlying conditions.
I appear on BBC TV and then on NBC Nightly News with Bob Bazell and Brian
Williams. Press stuff starting to heat up. I think that the HHS and Jenny finally realize
what I can do with the press.
Released by Chairman Rand Paul
213July 30, 2009 – Appeared on MSNBC today with Dr. Nancy Synderman and a vaccine
nihilist named Diane Miller. She was a nerd who said we should not vaccinate anyone
with flu vaccines since they do not work and they are dangerous. Nancy and I
annihilated her.
July 31, 2009 – Got called by Mike Gerson who is getting very interested in needle
exchange programs and will do a piece on it in The Washington Post.. He called from the
mobile unit that goes around DC doing needle exchange. He was very excited in a
positive way telling me that he is now converted to a “true believer’ in favor of needle
exchange. He wanted to know from me what the scientific data are. I told him the story
of the Shalala Committee that I was on with Harold Varmus, David Satcher, Alan
Leschner, etc. where Donna asked us to do a “meta-analysis”-type look at the literature
on needle exchange and ask 2 questions: 1) does needle exchange promote drug abuse
and 2) does needle exchange decrease incidence of HIV infection among drug users. We
found clearly that it did not promote drug use and did decrease HIV infection. We
presented the data to Donna who strongly recommended a federally funded needle
exchange program and called the WH to indicate this. To all of our dismay, the WH
rejected this for political reasons. Drug Tsar McCaffrey did not want it; neither did
prominent black Congressmen like Charlie Rangel (Charlie thought that it might be
interpreted as a signal that we had given up on the black community). In any event, Mike
was thrilled that the science backed up his impression. As a background, the Congress
just recently lifted the ban on federally funded needle exchange, only with the proviso
that such programs cannot be implemented within 1000 feet of school, park, recreational
facility, etc. This is silly since it blocks out most of the entire city in most places.
August 1 – 10, 2009 Much press regarding the beginning of the vaccine trials for H1N1.
I was on ABC, MSNBC, multiple radio shows, Diane Rehm Show, etc. discussing the
H1N1 issues.
August 5, 2009 - Mike Gerson wrote an editorial in the Washington Post describing his
impression about the importance of needle exchange programs. He quoted his
conversations with me. Also, Chris and I had dinner over Mark Dybul’s and Jason
Claire’s home on Wallace Place is NW DC. Josh Bolten was there with his partner Dede
and her daughter Rachel. Josh had just spent a couple of months in Africa (The Gambia)
with the Maryknoll priests. We reminisced about the White House days and PEPFAR.
August 6, 2009 – Appeared on Diane Rehm show with Bruce Gellin discussing H1N1
August 7, 2009 – First patients injected with H1N1 vaccine in NIAID sponsored VTEU
clinical trials. Much media attention.
August 8, 2009 – Appeared on Good Morning America to describe the H1N1 clinical
trials.
August 9 – 24, 2009 – Our clinical trials with the VETUs on the H1N1 vaccine in adults,
elderly for dose (15 versus 30 ug) and number of doses (1 vs 2, 21 days apart) began on
Released by Chairman Rand Paul
215 In any event, now finally Jenny Backus is “putting me out there” with my leading the
HHS press conference on August 11 to make the announcement with the Secretary and
doing all of the press, i.e. Newshour, CNN Situation Room, front page NY Times,
multiple NPR interviews (“All Things Considered” , etc) Washington Post, all print from
everywhere, NBC Today Show, CBS Evening and Morning News, MSNBC, NBC
Nightly News, etc. Still and amazingly, she did not allow me to comment on the NIH
data on the evening of Sept. 9th when the NEJM data from the companies came out since
we were scheduled for a Secretarial Press briefing at 1:00 PM Friday. When the press
called me on the night of Sept.. 9 and heard that I could comment on the NEJM papers,
but not our data, they went nuts saying that the HHS were crazy and that the story is
tonight for tomorrow and not tomorrow for the next day. The Editors needed to know
whether the NIH data corroborated the company data; otherwise they were reluctant to
play it up. Finally, I e-mailed Jenny, Laura Petrou, and Niki Lurie telling how crazy this
was. Jenny finally relented and let me call back the print people to tell them only that
“our data corroborate the companies’ data”, without giving details. Jenny is stupid and
nuts. She refused to allow me to go on TV until tomorrow afternoon. Wolf Blitzer
would have none of this and on his Situation Room evening show on Aug. 9, he called
me directly in my office and put me on TV as a phone-in voice interview. I did not know
that he was going to do this until a minute before he did. Jenny was pissed. Yet, the next
afternoon and evening and on Sept. 12, Jenny let me do everything.
There was, however, a big blowup with crazy Jenny who attacked Patty Conrad and
others at NIH since she claimed that we were blaming her for not letting Fauci go on the
air (Duh!!!! That is the truth; that is what she is doing). She wrote a vicious e-mail
saying that she was very angry because we were “throwing her under the bus” with the
press since then they will think that she is muzzling me…..which she is. She really is a
crazy lady.
Also, we got great news on Sept. 11 that the Thai canarypox (ALVAC) + AIDSVAX
(gp120) HIV vaccine trial showed a 31% efficacy that was clearly statistically significant.
Sept 12 – 17, 2009 –Still an extraordinary amount of attempt to “control messaging about
H1N1 on the part of HHS and particularly Jenny Backus. They just have a different
philosophy that they control message and a person can only speak about what their
official responsibility is, i.e. I cannot talk about trends of disease since this is a CDC
issue – the most ridiculous thing I have ever heard of. Also, quite insulting to me sine I
have been talking broadly about ID issues for 25 years to national press
Obama having real trouble selling his health care reform plan.
Sept. 17, 2009 – Went to State Department for swearing-in of Eric Goosby as the new
head of the Office of Global AIDS Coordinator (PEPFAR+). Took place at 4:00 PM in
Franklin Room, presided over by Secretary Hillary Clinton. She recognized me in the
audience and made a comment during her official remarks about the great work that I
have been doing for so many years with HIV/AIDS. Got a chance to chat with her after
the ceremony.
Released by Chairman Rand Paul
216Sept. 21, 2009 – More good news. Pediatric H1N1 clinical trials showed good responses
at 8 to 10 days with 1 dose of 15 ugs in kids 9 to 17 and lesser response in kids younger –
just like seasonal flu vaccine. I led a press briefing.
Sept. 24, 2009 – Roll-out of the Thai trial results. 31.2% efficacy; p – 0.039. 16,000 in
randomized trial in relatively low risk heterosexuals in Thailand. 74 infections in
placebo, 51 infections in vaccines. Press ate it up. The usual suspects who wrote the
2004 Science letter criticizing my decision to fund the trial made comments either for
attribution or “anonymously” that they were not impressed and probably thought that it
was a fluke (John Moore, Ronald Desrosiers, etc.) I was very reserved in putting it into
perspective as this not at all being the “end game”, but an important start since this was
the first time in over 2 decades that we have gotten even the slightest positive signal in
any HIV/AIDS vaccine. The lack of major immune parameters, i.e. neutralizing abs and
CTLs tell me what I suspected all along that we are probably not looking at the right
measures of immunity. Of note the vaccine had no effect on viral load of those that did
get infected.
Since this was not H1N1 and since Jenny Backus probably does not even know what
HIV is, I was given blanket clearance for the Press. I had the most media exposure that I
have had since the anthrax situation. Front page or prominent coverage in all major print
media (NY Times, Wash Post, AP, Reuters, etc. Also, prominent appearances on every
TV outlet – NBC Nightly News with Bob Bazell, CBS Evening News; ABC World News
Tonight, Wolf Blitzer Situation Room on CNN; Fox News; Canadian TV; BBC;
Bloomberg; World News with Katty Kay; Radio – NPR – All Things Considered;
WTOP
Sept. 29, 2009 – Bono/U2 concert at FedEx stadium. Logistic disaster for me. I was
invited by Bono to attend the concert and be present at a reception in the “Round Room”
of the FedEx stadium before he was scheduled to go on at 8:30 PM. I was very busy in
the office preparing for the visit to the NIH the next day of Sec. Sebelius and President
Obama. By the time Chris and I drove to the stadium we got caught in 2 hours of traffic
and a disaster trying to get parking in the stadium lots. I missed the reception, did not see
Bono. He probably thought that I did not show and so he did not do what he has done
several times with concerts and appearances which is to point me out in the audience and
praise me. Too bad, but that is the way it goes sometime.
Sept. 30, 2009 – Wonderful day at NIH. POTUS came in the AM with the Secretary,
Bill Corr (Deputy Secretary) and Francis. Marston Linehan and I showed him a lab in the
new CRC. First Marston spoke about the genetics of renal cancer and then Francis spoke
about the cancer genome atlas. I then spoke to the POTUS about the history of HIV
research here in the Clinical Center. I spoke about how I admitted the first AIDS patients
in 1981 and how they all died. I then spoke about the major advances in antiretroviral
drug development and testing that has transformed the treatment and survival of HIV-
infected individuals. I spoke about the recent results of the Thai HIV vaccine trial. He
was very engaging, pleasant, funny but serious about the subject. He definitely now has
fixed in his mind who I am. When I told him that I had been here since 1968, he joked
Released by Chairman Rand Paul
218Oct. 10, 2009 – Chris and I had a great dinner in the Placido Domingo room of Café
Milano as guests of Kathryn and Wayne Reynolds on the occasional of Derek and
Beverly Joubert’s visit. They are award-winning film-makers for National Geographic
who photograph and film lions, leopards, and cheetahs in the wild. Typical enjoyable
Reynolds dinner with many famous guests including: Gen James Jones, Terry McAuliffe,
Sam and Jan Donaldson, Tom Daschle, Brendan Sullivan, Fred Hiatt, Tom Friedman,
Alexandra Cousteau (Jacques’s granddaughter),
Oct. 13, 2009 – Still extremely intensive media exposure with national media
appearances a few times per week and heating up. Had dinner at Zeke Emanuel’s home
in DC with Chris. Corby Kummer was there as was Rahm Emanuel and his children.
Other government people whose names I unfortunately forget.
Oct. 14, 2009 – Flew to NYC to give Parker Memorial Lecture to the Dept. of
Microbiology and Immunology at Columbia Medical School. Gave the a4B7 lecture that
was very well received.
Oct. 16, 2009 – Went to White House for top secret meeting and counterintelligence
briefing by FBI and CIA. Apparently, Russians are monitoring the evolution of our
Biodefense campus at Fort Detrick. As usual, a lot of soft stuff. I certainly would expect
that they would be doing this since they suspect that we are doing offensive bioterrorism
as opposed to defensive biodefense.
Oct. 18, 2009 – Take off to Paris with Patty Conrad for the 2009 AIDS Vaccine meeting
of the IAS and Vaccine Enterprise. Extremely successful meeting in many ways. The
RV144 (Thai trial) results were formerly presented coinciding with the online publication
of the results in the NEJM. There was significant controversy surrounding the role-out of
this vaccine a couple of weeks ago (see above). The complete data showed that the effect
was modest, but real. Apart from a few remaining skeptics, the issue now is to learn
from this by examining any correlates of immunity.
I gave the closing talk on Oct. 22 together with Francois Barre-Sinoussi. My talk was
extremely well-received as being visionary. I thoroughly enjoyed preparing and
delivering the talk. I discuss the Thai trial, but also the need to pursue low-dose mucosal
challenge models in the non-human primate (NHP). Also, I spoke about the importance
of studying the early events in HIV infection for insight into the type of immune response
that we need to elicit. Also, spoke of the differences in the transmitting versus the
chronically replicating virus.
Oct. 23 – 25, 2009 – Things really heating up with the press jumping all over the USG
for “overpromising” the number of doses of vaccine that would be available. In fact,
despite my warnings, BAARDA (Robin Robinson – nice guy, but naïve) believed the
pharmaceutical companies that they would have 160 million doses by October 15. In fact
they had 11 million and instead of ultimately getting 250 million, we are lucky if we get
140 million. Big gap between supply and demand with long lines for vaccine and
widespread flu activity in 46 states. Perfect storm.
Released by Chairman Rand Paul
219 I have been as much media as in the anthrax days. Just on October 23-25 I was on 11
major networks and cable trying to explain the vaccine supply problem – Today Show,
NBC Nightly News, multiple MSNBCs, CNN Situation Room, CNN American Morning,
Charlie Rose, NPR, WTOP, Good Morning America, Jim Lehr’s The NewsHour, BBC,
etc.
Oct. 25, 2009 – Reception and dinner in Georgetown 1692- 31st Street, N.W., hone of
Susan and David Axelrod to view live the “60 Minutes” show about their ordeal with
their daughter Lauren’s epilepsy that she has had from birth and that now at 28 years old
has left her with significant brain damage. They are wonderful people and have started
the organization called CURE (Citizens United for Research in Epilepsy) to do research
on epilepsy. Typical high-powered DC gathering: Rahm Emanuel, VP Joe Biden and Jill
Biden, Gen. James Jones, Mort Kondrake, Al Hunt, Bruce Reed, Linda Douglas (ABC),
Bob Bennett, and many, many others.
Oct. 26, 2009 – Media Frenzy continues – Lou Dobbs, Campbell Brown (CNN), BBC
Oct. 27, 2009 – Extensive interview with Dan Rather for his Cable show “Dan Rather
Reports”. Very nice person. We related well and he told his producer (Patty heard the
conversation) that I was a “superstar”.
Oct. 28-29, 2009 – Press is jumping all over HHS for delay in vaccine distribution. Front
page stuff and all networks. They are calling it “Obama’s Katrina”.
Nov. 3, 2009 – I continue to be all over the press – last night CBS Evening News; today
CBS Morning News to explain the complex issues of why we do not have a lot of vaccine
at hand – the virus just is not growing very well in eggs and much against my advice,
HHS (BARDA, Jenny Backus) promised that we would have a certain number of doses
and now we do not. They relied on and believed the projections from the pharmaceutical
companies when I told them not to. They wanted to give a crisp message (they were still
in campaign mode) and I told them not to. Now, everyone looks to me for what to do and
they are putting me out on all of the shows. Actually NIAID is the only one giving good
news sine our pregnancy trials and pediatric trials are giving good data – only 1 dose of
15 ugs for pregnant women is required for robust response and we proved that 1 dose for
older kids (10 – 17 years) is good and 2 doses for younger kids (6 months to 9 years is
required). I announced this at a press briefing at HHS yesterday. This is in conflict with
WHO who say that we should give 1 dose to all kids.
Nov. 4, 2009 – Major House Appropriations briefing/Hearing chaired by David Obey.
Witness – me, Tom Frieden (CDC), Niki Lurie (ASPR) and health commissioner from
Alabama and ?. Tough questions by members and staff regarding availability of
vaccines. I came out looking good, but it was a intense hearing. Next day (Nov. 5) big
picture of me on page 3 of both the Washington Post and the NY Times.
Nov. 5, 2009 – Image and message issues continue to deteriorate when it was announced
today that workers from Goldman Sachs, Citibank and other Wall Street firms had gotten
Released by Chairman Rand Paul
220H1N1 vaccine as pregnant women wait in line. The CDC is being blamed since they are
responsible ultimately for distribution. In fact, CDC takes orders from States and locals
and then distributes the vaccines through a contract with McKesson Corp, which sends to
over 150,000 distribution sites within the states according to how the cities and states
decide to distribute based on their best judgment. Since the Wall Street firms have large
clinics, they can easily distribute vaccine to their pregnant employees and those with
underlying conditions. It was Mayor Bloomberg’s choice, but the image did not look
good and the CDC took flak for it.
Still getting massive (couple of times daily) media exposure. Media interest paused for
a few days due to the terrible tragedy at Fort Hood (Texas) army base where a crazed
Army MD psychiatrist who trained at USUHS and Walter Reed and is a Muslim (born in
USA) went on a shooting rampage and killed 13 and wounded 30 soldiers getting ready
to deploy to Afghanistan.
Am extremely busy and very fatigued!
Nov. 10, 2009 – CDC and HHS still getting hammered by the press because of the delay
in availability of vaccine. Press frenzy continues. I am coming across relatively
unscathed because of my long-standing credibility. Briefed the editorial board of the
Washington Times yesterday and today my picture was on the front page of the
Washington Times. Also, continue on TV and NPR.
Nov. 11, 2009 – Pressure and press frenzy continues. Hurricane Ida flooding the mid-
Atlantic. Been raining here with no real hurricane for days. Pre-taped the “Power
Player” segment for FOX News that will show on Sunday – 11-15-09.
Dinner at Richard Ben-Veniste and Donna grill’s home. Present were: Gerry and Ellen
Sigal, and 2 friends of Richard’s and Donna from LA. Terry and Denise –
environmentalists.
Nov. 12, 2009 – Two day of Science Management Working Group (SMWG) of which I
am a member of the Intramural and Clinical Center Subcommittee. This evolved out of
the NIH Reauthorization Act of 2006 to look at the structure and function of the NIH.
Chaired by Norman Augustine. On MSNBC and Fox News today.
Nov. 13, 2009 – More of the same. Things getting very testy with the press and the
Republicans blasting the Administration as having another “Katrina” with the H1N1 flu.
Still long lines and contradictory issues of ½ people do not want to vaccine because that
think it is not safe and ½ are waiting on line for it. Lose-lose from a PR standpoint.
Picture on page B1 of the Post (Metro Section) for the NIH-DC AIDS initiative. On
NBC Nightly News.
Nice dinner at Ambassador Nancy Brinker’s home (Ritz-Carlton Apartments in
Georgetown in honor of Mark Dybul. Nancy was Chief of White House protocol under
Pres. George W. Bush. Beautiful Apartment overlooking Georgetown and the Potomac
Released by Chairman Rand Paul
221River. About 16 people. Nancy is the President /Director of the Susan G. Komen
Institute named after her sister who died of breast cancer. Nancy is now interested in
Global Health, particularly cancers (breast mostly) in women in developing countries.
Interesting guests. I particularly liked speaking with Kathleen Parker, syndicated
columnist and frequent Sunday News Show commentator and guest. Also, there were
Pamela Stevens (former White House Press person) and other global health people.
Nov. 14, 2009 – Presented my NIAID “update” to the Board of the AAAAI at the Hyatt
Capitol Hill. Ali’s NCS Cross Country Team wins the Maryland State Championship.
Ali is one of the Senior Captains of the Varsity of which she is one of the starting 7.
Nov. 15, 2009 – Amazing Sunday. Appeared on NBC Today Show in the AM, Fox
News highlighted me as “Player of the Week” with a several minute segment. Did “The
Forum” with Dean Sam Lloyd at the National Cathedral. Big success with big crowd.
Consists of a “conversation” between Dean Lloyd and me about my life and work
followed by questions from the audience. Also did CBS Evening News. Exhausted at
end of day.
Nov. 17, 2009 – Went to NYC to receive the Accordia Award for Public Service. This is
the new version of the Infectious Diseases Institute started by merle Sande and funded by
Pfizer. Mark Dybul, Julie Gerberding and others were there. Was in NYC anyway for the
DDCF Board of Trustees meeting in the AM and went up to see Megan at Columbia for a
couple of hours. It is always wonderful to see Megan and I always have a great time
when I visit her. We had a nice lunch.
Nov. 20, 2009 – Had dinner with Chris over Francis and Diane Collins’s house with
Regina Benjamin, the newly appointed Surgeon General. Pleasant, but I believe that she
is going to be a non-entity. She is a bit over her head.
The H1N1 pandemic is starting to die down with widespread disease going from 48
states to around 30 states. Much less press interest. A lot more vaccine now available.
Nov. 23, 2009 – Went to NYC to give remarks at the Healthright international dinner at
the Mandarin Hotel. My remarks were honoring Jonathan Mann. Gave a warm speech
about him and his character. His daughter Naomi was there and was very touched by my
presence and remarks. She admitted publicly in her remarks that everyone in the family
(even when she was a young girl) knew who “Tony” was since Jon would often speak of
me. She said that she realized that Jon and I sometimes disagreed but that her father
always greatly respected me. Nice evening. After dinner I went up to Columbia to see
Megan for an hour. As usual, it was great to see her.
November 24, 2009 – Briefed the Foreign Press Core on AIDS at the National Press
Club.
Released by Chairman Rand Paul
222Nov. 30, 2009 – Attended a World AIDS Day event at the White House (South Court
Auditorium. Sec. Clinton and Sec. Sebelius were there as was Eric Goosby. They spoke
about PEPFAR. Of note, striking difference from last year when anyone at White House
mentioned PEPFAR, they would recognize me in the audience as the main architect of
the Program. No one did that this time even though Hillary Clinton saw me and warmly
waved at me from the stage. I believe that the new administration speech-writers and
staff just have no idea who I am. Sic transit Gloria. Sebelius was her usual cold self and
did not even make eye contact with me. Also, (amazingly) when she was with me a day
or 2 later actually asked me as we were on the Hill together to speak with the
Congressional Black Caucus (who never showed up – ugh!) “now just what do you do
and what is your official title”. When I told her, she smiled and said: “I just think of you
as “the vaccine guy”. She did not mean any harm, but she is really clueless….or actually
uninterested in any interpersonal relationship at this level.
Dec. 2, 2009 – Had dinner with Peggy Hamburg at Indique Restaurant on Connecticut
Avenue. Just to catch up on how she is doing as Commissioner of FDA. Really nice
person; has not changed.
Dec. 5, 2009 – Went to Holiday Party at Sam and Jan Smith Donaldson’s home in
McLean. Usual warm and enjoyable time. Chris was in Istanbul teaching a course in
Bioethics and so I went alone. Usual cast of characters: Colin Powell, General Casey,
Ben Bradlee, Lee Hamilton, Antonin Scalia, Nina Totenberg, Bill Plante, John and
Debbie Dingle, George Will, Terry McAuliffe, etc. etc.
Dec. 9, 2009 – Time Magazine came out with a list of the 10 most important Medical
breakthroughs of 2009. #2 was an “AIDS Vaccine” (the Thai trial) and #4 was an H1N1
vaccine. Of note, I played a significant role in the development of both of these.
Dec. 12, 2009 – Wonderful Holiday sit-down dinner party at the Academy of
Achievement Town House on 16th Street (Black Tie) hosted by Wayne and Catherine
Reynolds. Usual cast of stars at the dinner – Senators, Congressmen, Media, etc.
“Mystery” gust entertainer was Tony Bennett. The Reynolds’s have been very generous
to regularly include us at these functions.
Dec. 13, 2009 – Holiday Season in full swing with parties, etc. Today parties at Nicki
Lurie and Jesse Goodman’s; Bill Haseltine’s and Hugh and Mimi Auchincloss’s. Flu
activity really slowing down with sharp drop in cases. More vaccine now available and
so push to vaccinate.
Dec. 14, 2009 – Gave big talk at CSIS on new treatment approaches to HIV/AIDS at their
headquarters on 18th and K Streets, NW. Evening reception at Stone house for Julio
Frenk. Good guy. I knew him slightly when he was Minister of Health for Mexico.
Dec. 15, 2009 – Much activity at HHS level to get the “team” to work on pushing vaccine
since much is now available. HHS is getting anxious (Jenny Backus, Laura Petrou, etc.)
about possible “end-of-the-year” news stories that might criticize HHS and USG for
Released by Chairman Rand Paul
223doing a poor job with H1N1. Had an interesting 90 minute with Washington Post
Editorial Board (Fred Hiatt and Jonathan Capehart) to discuss the response to H1N1.
Meeting was me, Peggy Hamburg, Tom Frieden, and Jenny Backus.
Dec. 17, 2009 – Continuing on with the HHS push to try to get a final positive spin for
end of 2009 on our response to H1N1. They arranged a Press Briefing at the National
Press Club with me, Secretary Sebelius, Tom Frieden, Peggy Hamburg, Nicki Lurie, Jess
Goodman, etc. to explain what we have done in response to H1N1.
Dec. 24, 2009 – Traditional “great” dinner for my birthday at sister Denise’s home. Over
the years, Jenny, Megan and Ali have come to treasure this tradition similar to some of
the family traditions that Denise and I treasured like dinner over Grandma Abys’s home
for the holidays. In the AM had my traditional birthday breakfast hosted by Chris and the
girls at the Silver Diner on Connecticut Avenue.
Dec. 30, 2009 – Lunch at the White House mess with Heidi Avery. She is Deputy to
John Brennan at the National Security Council at the White House. She is former CIA
and Counter Terrorist Unit Chief. She want to talk to me about how we should broadly
handle “all threats to the public health” instead of going incident by incident as with
pandemic flu. She wanted to speak with me because she heard that I was a visionary
about these issues. Very enjoyable conversation. Obviously, WH sources know about
me despite the sometimes discouraging relationships that I have had with HHS and their
lack of appreciation about who I am and what I have done over the years.
Jan. 6, 2010 – Big Global Health Research Summit held at NIH (Fisher’s Lane) with big
hitters attending. Convened by Francis Collins to flesh out suggestions for his Global
Health Initiative as one of the 5 pillars of his tenure. Jack Lew from State was there as
were Eric Goosby, Zeke Emanuel representing WH, and many, many global health stars.
Good meeting.
Jan. 12, 2010 – Finally had the launch of the DC – NIH HIV/AIDS Partnership. Went to
Anacostia for a inauguration and press conference with me, Mayor Fenty, Councilman
David Catania, Shannon Hader and Pierre Vigilance from DC Dept. of Health. Got good
press with Channel 5 FOX News. Also, had good and lengthy interview with Wolf
Blitzer on “The Situation Room” that evening on National Influenza Vaccination Week
(Jan. 10-16). Again, the latter is part of the push to get people vaccinated. Of note, all
over Europe there are tens of millions of doses of vaccine that countries like France,
Germany, Italy are turning back to the company since they are unused. Interesting issue
might arise about the companies no longer wanting to respond to crises since they make a
lot of vaccine an then countries cancel the orders. More to come on this.
Jan. 19, 2010 – Heidi Avery (see Dec. 30, 2009) called a meeting this evening (7:00 to
8:45 PM) in the Situation Room of the West Wing to discuss the broad plans to handle all
public health threats, i.e. existing, naturally emerging and deliberately emerging. Present
at the meeting was Zeke Emanuel, Nicki Lurie, Peggy Hamburg, Tom Frieden by phone
from Atlanta, Jesse Goodman, Brian Kamoe, George Korch, Richard Hatchett, James
Released by Chairman Rand Paul
224Lawlor (latter 2 are my employees detailed to Heidi), Mike Kurilla, among others. Heidi
had asked us (NIH, CDC, FDA, HSS) through Nicki Lurie to prepare a 1-pager on this
initiative from each of our perspectives. Nicki consolidated the 1-pagers and we
presented the concept to Heidi. Heidi is aiming to get the POTUS to announce some sort
of initiative in the State of the Union Address on January 27. I am very impressed with
Heidi and her no-nonsense style of getting to the point and the question at hand. Heidi
mentioned to me as we left the Situation Room that she was relying on my “vision” to
help get this going. Let us see what comes of this.
Jan. 21, 2010 – Has long meeting in my office and private dinner at Trattoria Sorrento in
Bethesda with Eric Goosby, the Ambassador at Large in charge of PEPFAR and the new
Chief of the OGAC (Office of Global AIDS Coordinator) to discuss the future of
PEPFAR. Recall that Eric was one of the people that I flew in the put the icing on the
cake of convincing the White House in 2002 that I was right about starting PEPFAR. In
any event, we discussed the issues of broadening the mandate of PEPFAR and integrating
it in a more comprehensive health systems partnership with the developing countries.
Unlike in the past, he is in favor of “operational” or “Implementation” research to
determine best practices associated with PEPFAR mission. He confided in me the issues
in the Department of State in putting the President’s Global Health Initiative (GHI) under
USAID with new Director Raj Shah. Since PEPFAR in included within and is the major
part ($51 Billion out of $63 Billion) of the GHI, the question remains will Hillary Clinton
put PEPFAR under USAID. Given the ineptitudes of USAID, I told Eric that he should
never accept that. He agrees and actually said that he would resign if that happened. I do
not think that things will happen that way.
Jan. 25, 2010 – Had strategy meeting in Building 31, Room 7A24 and subsequent dinner
at Positano restaurant in Bethesda to determine the Institute’s strategy for vaccine
research following the RV144 Thai trial results. I called in a small group to hash out the
issues in intense deliberations. Present were: Larry Corey, Bart Haynes, Gepi Pantaleo,
Louis Picker, Cliff Lane, Carl Dieffenbach, Peggy Johnston, Hugh Auchincloss, Carol
Hudgings, Patty Conrad. General consensus is to continue with basic discovery, but to
go ahead with other Phase 2B trials, particularly a poxvirus (likely NYVAC) prime and a
protein boost (Clade C) in Africa. Will continue this discussion next week with the
AIDS Vaccine Research Subcommittee (AVRS).
Jan. 26, 2010 – Another meeting with Heidi Avery at the Situation Room in the West
Wing of the WH to further discuss the new initiative to counter all public health threats
including bioterror, but also all emerging and existing Health threats. Mike Kurilla and I
have been fine tuning the NIH component. Present at the meeting was the same group as
on January 19, 2010 (see above0 . Also present was the POTUS’s science advisor John
Holdren. We now have a 1-pager that Heidi has discussed with the POTUS and that is
being considered for a brief comment in the State of the Union (SOTU) Address.
Jan. 27-28, 2010 – Went to Boston to be the Bulfinch Visiting Professor at
Massachusetts General Hospital and Harvard Medical School at the invitation of Denny
Ausiello (Chair of Medicine). Great visit, particularly interactions with House Staff and
Released by Chairman Rand Paul
225Fellows. Gave the Bulfinch Lecture on Pandemic Influenza; extremely well-received by a
standing room only crowd. On the trip home when I landed at DCA, I bought a hot dog
since In was starving. I immediately ran into Nina Tottenberg and her husband David
who god-naturely chastised me for eating the hot dog. With a minute I walked to a news-
stand to buy a Washington Post. I ran into Karl Rove who jokingly said he would tell the
world that the great Dr. Fauci was caught eating a hot dog. We had a good laugh.
On evening of Jan. 27 POTUS mentioned the sentence that I crafted for Heidi in the
SOTU Address: “And we are launching a new initiative that will give us the capacity
to respond faster and more effectively to bioterrorism or an infectious disease — a
plan that will counter threats at home and strengthen public health abroad.” This is
the second SOTU Address where my words were included. Other was the PEPFAR and
Project BioShield statements in the Jan. 28, 2003 SOTU address by Pres. Bush.
Jan. 29, 2010 – Met at the White House (EEOB 234) with Heidi Avery, Zeke Emanuel
and several Pharma people whom Zeke had called in to ask the question of what would
they need to work with us on this project that Heidi and the rest of us have been
developing regarding developing a transforming approach to developing countermeasures
for all public health threats. Present at the meeting were: Peter Kim (Merck), Lloyd
Klickstein (Novartis), Rob Mashal (NKT Therapeutics), Sandy Hecker (Hecker and
Associates), Lynn Marks (GSK), Richard Hatchett.
Feb. 1, 2010 – Another meeting in the Situation Room of the WH with Heidi Avery with
the usual cast of characters. For the past 2 meetings, Andy …. From DoD has joined as
has John Holdren from PCAST. There is tension building where the HHS people
(particularly Nicki Lurie and to some extent Jesse Goodman, Peggy Hamburg and Tom
Frieden are getting nervous about the boldness of the proposal and whether we can
“deliver” on the promises. Heidi is trying here best to explain that we need a bold
initiative and if we are not bold and transforming, we will get nowhere. They are
concerned that this is moving quickly particularly since Heidi is talking about possible
face-time with the POTUS to have him accept and sanction this bold “new initiative’. I
am leaning much more towards Heidi and have served as somewhat of an intermediary to
try to alleviate their concerns. They are somewhat in the weeds. Heidi has been calling
me up at night to get my confidential feedback about how we can get the HHS group
from being so conservative.
Feb. 2, 2010 – Had AIDS Vaccine Research Subcommittee (AVRS) meeting at the
Bethesda North Marriott Hotel to discuss the way forward following the Thai trial
(RV144). We discussed the same issues that I discussed at the smaller meeting of my
“Kitchen Cabinet” on Jan. 25. As usual, people had insecurities about pursuing a path
that was not their path. In addition to the Jan. 25 group, also present were Dennis Burton,
Bruce Walker, Nelson Michael, Jerome Kim, Debbie Birx (now at CDC). I made it clear
to them in no uncertain terms that they needed to speak up openly and not stay silent and
then after the meeting say they disagreed with the conclusions. It turned out to be a good
meeting since they obviously heard what I said.
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226Feb. 4, 2010 – Opened the Genomics Blue Ribbon Panel at the Bethesda North Marriott
to plan the direction of genomics research for NIAID. All the stars were there – Ian
Lipkin, Eric Lander, etc. Eric gave a great speech. About the use of genomics in
infectious diseases. That evening presented my usual “State of NIAID” talk to the ASM
Executive Committee.
Feb. 5 and 6 and Feb and Feb 9 and 10 – 2 worse snow storms in the history of
Washington, DC. Shut down schools and government for a week – it was a 0ne (32
inches at IAD) – two (20 inches in DC) punch. During this time we intensified the
development of the PHEMCE (Public Health Emergency Medical Countermeasure
Enterprise) Initiative via Heidi Avery. Getting hot and heavy in that the HHS folks are
getting cold feet. Although good friends of mine – Nicki Lurie appears afraid and over
her head. Jesse Goodman is forever in the weeds. Peggy Hamburg is cautious but just
now is starting to realize that this train is moving.
Feb. 8, 2010 – Whole city is socked in with snow, but we still had meeting in Sit Room
with the usual cast of characters. Heidi has obtained 1 hour face time for us with the
POTUS, but the HHS crew is afraid. Issue is that they think that the concept is too bold
and Nicki Lurie is afraid that it will supersede the IOM-led review of the enterprise that
Sec. Sebelius has ordered for Feb. 22-23 and that must report to her by March 31. Heidi
wants to leap over all of the nonsense and get the POTUS buy in. The pillars of her
transforming plan are : 1) Multi-use principle – NIAID has already been pushing for this
in the sense of partnering with industry to develop multi-use products and advance new
platform technologies; 2) Collaborations, Partnerships and Cooperatives; 3) regulatory
innovation and Advancement of regulatory Science; 4)Product Development and
manufacturing services; 5) End-to-end Multidisciplinary Project Management (see entire
document in records of My Documents).
Feb. 10, 2010 – We (the HHS team) brief Bill Corr (Deputy Secretary). Again
conservative concern. I am all for Heidi’s initiative. These people just do not understand
how important it is to get personal support of the POTUS (remember PEPFAR).
Again, multiple conference calls with Heidi fine-tuning the document. Richard Hatchett
(who actually works for me in DAIT, but is detailed to Heidi) and Heidi often call me late
at night for help in getting this group off their asses. They are afraid that she will
promise too much. She keeps saying (and I totally believe her) that we are not going to
promise the POTUS anything, we just need to get his buy-in and then we will implement
what we can.
Feb. 11, 2010 – HHS team briefs Secretary Sebelius over the phone. She is smart, but
clueless about what all this means. Nicki Lurie is inarticulate in explaining it to her.
Nonetheless Heidi is going to give it a go with the POTUS even though she is terribly
frustrated with the HHS people except for me. My time has been totally consumed with
this despite the shutdown of everything with the snow.
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227Feb. 12, 2010 – Meet with the POTUS from 2:00 to 3:00 in the Situation Room. Richard
and Heidi present and the HHS team answered questions. I was not shy in telling the
PTUS what I thought. He said “Are we making this more complicated than it should we?
Why not contract out for the relatively limited number of countermeasures that we have
Intel. On that could be threats”. I reminded him that in his SOTU address he said that we
would develop an initiative to counter all threats to public health even naturally emerging
infections. I then told him that the dual use and new platform technologies were essential
to get industry involved since they would not take the investment risk unless we helped
them with the technology, etc. He agreed. He recognized who I was without even an
introduction and called me “Tony”. All in all, the meeting went well and he said that he
endorsed the plan. Parenthetically, The traffic was horrible getting to the WH via the
GW parkway by Taxi. I took a taxi because the METRO Red Line shut down due to a
derailment. Stressful getting there, but great to have 1 hour face time with the POTUS.
This is now the 5th POTUS that I have personally advised via serious face-time.
Feb. 15-17, 2010 – Went to annual CROI meeting in San Francisco. Gave Opening
Session Plenary on “The HIV/AIDS Research Agenda: A View from NIAID”. Gave a
bold and provocative talk about the high risk, high impact, potential “game-changer”
research that we plan to do over the next few years. The 3 “pillars” of this research are 1)
Aggressively seek, test and treat infected individuals. However, the math tells us that the
treatment paradigm in a vacuum will never end the AIDS pandemic since more people
get infected than get put on treatment. Hence we need to do something different such as
getting people who are on therapy off therapy by developing a 2) CURE for HIV – tough
challenge. Also we need to 3) Prevent new infections by a) ARVs as prevention – ARV
containing microbicides; PrEP; test and treat; and b) vaccine. Beautiful days in SF.
Stayed at the Westin St. Francis. Many people said that it was the best and most
inspiring talk that I have ever given – “bold and challenging”.
On Feb. 17, I briefed by teleconference the PCAST working group about the POTUS
initiative and gave them background info. On the call were co-chairs Harold Varmus and
Eric Lander. Also, David Baltimore, Ed Penhoelt, Emilio Emini, Harvey Fineberg,
among others.
Feb. 18, 2010 – Another meeting at the Sit Room of the WH from 4:00 to 5:30 PM with
Heidi Avery and the “team”. Getting ready for the various meetings next week of IOM
(Secretary’s review), PCAST, and National Biodefense Science Board (NBSB). I
brought up that reports from these other meetings may confuse people regarding the
POTUS’s initiative to transform PHEMCE. Heidi will likely let the other meeting
happen, incorporate some ideas from them and still have the POTUS initiative be the
driving force of policy.
During the day prior to the WH had a visit from Rick Klausner. I had been talking to
Rock about these issue for awhile and he is very much in agreement with my stand on
how we need to transform the way the USG interacts with industry in the development of
products.
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228Feb. 23, 2010 – Continued activity in trying to dissect out what went right and/or wrong
with the response to H1N1 flu. Still considerable tension between Heidi Avery who
wants s “to transform” the system and make some leaps and the slow, careful (and
actually incompetent) response of the HHS people. Had the PHEMCE review led by
Nicki Lurie under the auspices of the IOM. Held at the House of Sweden on 2900 K
street by the Georgetown Waterfront. I presented a lively endorsement of the Avery plan.
L felt that it made the HHS people nervous. This reminds me of 25 years ago when I was
pushing HHS to accept the AIDS activists and they were conservatively reluctant. They
are not bold at all.
Feb. 25, 2010 – As per the “review”, a PCAST meeting c—chaired by Harold Varmus
and Eric Lander was held at the Carnegie Institution on 1530 P Street, N.W. with David
Baltimore, Tom Monath, Robert Coffman, Emilio Emini and others present. Their
purpose was to look at the response to H1N1 and report back to the POTUS. I presented
my theme of the absolute importance of developed a new paradigm of close interaction
between USG and industry whereby USG pushes and shares to risk of developing
innovative technologies (new platforms for vaccines and drugs) that industry can use for
their own profits while the USG then has it available to respond to public health threats
(existing, emerging and deliberate). I was very well received.
March 1, 2010 – Regular Monday evening meeting in the Situation Room of the White
House led by Heidi Avery with the usual cast of characters. Still inertia on HHS part and
agitation by Heidi. Couple of days later (~ March 3 or 4) Heidi called me at home at
around 10:00 AM very discouraged at the inertia and lack of imagination of HHS people,
particularly Peggy Hamburg, Nicki Lurie and Jess Goodman. Asked for my help in
getting the initiative going or she even said that it might be hopeless with this cast of
characters. She felt that Nicki was in over her head and that she was afraid of losing her
command of the situation instead of capitalizing on what Heidi wants to do. Heidi also
feels that Peggy is missing the big picture and that Jesse is hopelessly garbled in his
thought and expression. I will try to help her by formulating a plan with her to get this
initiative rolling.
March 5, 2010 – Gave my yearly talk to the Zuckernman Fellows led by Mort
Zuckerman and David Gergen. Then had the usual receptions that evening at Ronald
and Beth Dozoretz’s home at 3005 45th Street, N.W. (right around the block from my
house. Usual stars were there – Sonya Sotamayor, Desiree Rogers (Social Secretary at
the WH), Justice Breyer, Dave Gergen, Wolf Blitzer, Andrea Mitchell, etc/
March 6, 2010 – Under the continued generosity of Wayne and Catherine Reynolds to
Chris and me, we were their guests at the premier showing of the Opera “War and Peace”
at the Opera House of the Kennedy Center. Special elegant dinner before hand in the
Atrium followed by the opera. Guests were the usual DC lists of famous people: few
examples – Gen James Jones, Sen. Tom Daschle, Marcus Brauchli (editor of Washington
Post), many media people – Dana Priest, Wolf Blitzer, Sam Donaldson, etc. Long opera!
Released by Chairman Rand Paul
229March 16, 2010 – Research Amer!ca Awards Gala at the Andrew Mellon Auditorium on
Constitution Avenue. Usual cast of characters.
March 17, 2010 – For the past 2 Mondays have had the usual Situation Room White
House meetings with Heidi Avery . Same theme – she is pushing HHS and I am very
much on her side. Looks like a plan is taking shape. I am impressed with the relative
incompetence of the HHS group. They seem clueless and short on leadership. Tom
Frieden of CDC shines in my mind as an independent thinker with good ideas and a
person who marches to the beat of his own drum.
Gave talk to the NIAID Fellows on a “Career at NIH Monday, 15 March. They
loved it.
Radio and TV Correspondents Association Dinner – Black tie at Convention Center.
Terrific night. Went alone but met with wide range of the usual cast of characters: Chris
Wallace (Fox News – they invited me); multiple Senators, etc.
March 19 – 22, 2010 – Contamination of Rotarix (Rotavirus vaccine from GSK) with
porcine circovirus (PCV-1). Spent many hours on conference calls over the weekend
with FDA, CDC and HHS to determine roll-out. Difficult issue here is the message.
There is no indication that there is a safety concern here since PCV-1 does not cause
disease in pigs or in man; yet this virus should not be in the vaccine. It was at high
concentrations even in the seed stock. The message is that the FDA recommends putting
a hold on administration of the vaccine (without pulling it from the market) until the
situation can be examined more closely. The potential downside is that this vaccine is
used mainly in the developing world and if the vaccinations stop, kids will die of
rotavirus disease. Merck makes Rotatec, which is used mainly in the USA and so the
FDA recommends that where possible, clinicians switch from Rotarix to Rotatec. We
fully understand that this might not be possible in the developing world and so we
understand if they continue to use Rotarix.
March 24, 2010 – Continue intense WH meetings with Heidi Avery in Sit Room tonight.
I finally put together my version of how the USG should take responsibility for the
advanced development, preferably in a physical facility that we buy or rent. The facility
at Texas A & M is a good model. Heidi really likes the idea. Laura Petrou called me
and said that she heard that I was more forward looking about all of this than the FDA
(Peggy), CDC (Tom) and HHS (Nicki) and wanted to hear from me about my ideas. She
was actually receptive. The issue here is really that HHS does not want the WH (Heidi)
to get in front of the Secretary. Yet the HHS process is slow, too cautious and
bureaucratic. Heidi still calls me off line for my ideas.
March 27, 2010 – Phone call on Saturday with Heidi. She wants to get more money for
NIAID to help in the process of bringing investigators from concept to very early
development in order to increase the pipeline of products in addition to all of the things
that we have been talking about regarding “advanced” development.
Released by Chairman Rand Paul
230Mar. 29, 2010 – Continue with the Monday evening weekly meetings with Heidi Avery
at the WH Sit. Room. Usual suspects. Still Heidi pushing and everyone but me pushing
back. Peggy Hamburg seems her usual spacey self often not even having read the
documents that Heidi distributes for comment. Jesse Goodman (wonderful guy)
continues to be reserved and cautious in typical FDA fashion, but cannot articulate well.
Nicki Lurie is a good person, but over her head. In fairness to her, she is caught between
a rock and a hard place in trying not to let this get ahead of the Secretary who in my mind
is distracted or does not really care about this. Nicki keeps pushing back on Heidi’s
“transforming initiative”. Zeke Emanuel comes to most of the meetings and is with Heidi
and me in wanting to push this. In typical Zeke fashion, he is brilliant, but shoots often
from the hip. Mike Kurilla is doing a great job with me and probably understands the
proposed process better than anyone in the room. Andy Weber of DoD (assistant
Secretary) is a good guy, but he is just trying to keep the DoD in the “game”
Mar. 31, 2010 - Meet with Alan Bernstein (Executive Director of the “Global HIV
Vaccine Enterprise” (see above comments about my negative reaction to this unnecessary
group). Alan is a good guy, but is heading a superfluous organization. In any event, his
multiple layers of “working Groups” has come up with a Strategic plan for the
“Enterprise”. Peggy Johnston is all over this and so she shields me from the week-by-
week dealings of this organization (I am one of the Founding Council Funders). Meeting
in my office with Alan since wants me very much to approve of the plan since NIAID is
the major world funder of HIV vaccine research. Meeting In NYC next week of the
Enterprise Council and so he is here to pay respects and make sure that I am on board.
The Plan is OK, but NIAID will do what we think is best for vaccine development.
Later in the day, the HHS Flu team (me, Nicki Lurie, Jesse Goodman, Peggy Hamburg,
Tom Frieden, Laura Petrou, Jenny Backus, etc) meets with Sebelius in her private
conference room. We present the supposedly penultimate draft of the MCM Review that
she ordered and that we have been working on for weeks trying to reconcile it with
Heidi’s initiative. Nicki gives a terrible presentation; Sebelius is confused as to the
“scope” of the review that she ordered – was it a review only of medical countermeasure
(MCM) development or a review of end-to-end process of responsdng to health crises,
including flu. I tried to clarify for Nicki, and Sebelius agreed with me. We need to keep
it focused. Back to the drawing board on a few issues. One issue is how much money
should we ask for in the 2010 flu supplement and the 2011 budget to fulfill some of the
gaps identified in the review and in what is proposed by Heidi.
April 5, 2010 – After Action Review of the H1N1 response in Nicki and Jesse’s home in
Bethesda (near the Palisades section). Beautiful home with magnificent view of the
Potomac and the opposite Virginia shore. Beautiful sunny day. Present – Nicki, Jesse,
Robin, Steve Redd, Anne Schuchat, Laura Petrou, Makala Ross (OS). Good discussions.
April 6-7, 2010 – Went to NYC night before and had great dinner and time with Jenny
and Meg. I stayed at “W” hotel at Union Square. Went for run on April 5 evening past
Larry Kramer’s Apartment; called, but found out later that he was asleep on his couch
and did not hear the phone. In front of Larry’s Apt. (2 Fifth Avenue – right across the
Released by Chairman Rand Paul
231street from Washington Square Park), ran into Bob Bazell (NBC News), who live in the
same apartment.
Next AM (April 7) went to Enterprise headquarters and met with the leadership to
discuss the “Plan”. Beautiful day. I stayed for AM. Present were Alan, Tachi Yamada,
Peter Piot (new Chair of Council), Manuel Romaris (EU), Catherine (Kate) Hankins
(UNAIDS-WHO). Seth Berkley (IAVI), Jose Esparza (BMGF), Peggy Johnston, Yves
Levy (INSERM), Rafi Ahmed (Emory and chair of the Scientific Committee). Good
discussions. I kept them on track about what NIAID would or would not agree to).
April 14, 2010 – Dedicated the Special Unit at the Clinical Center for vaccine studies.
Honored Stewart Simonson for the role he played in pushing through the red tape to get
this done. Had nice ceremony with Cliff, John Gallin, Gen Jim Gilman (USAMRIID),
Stewart, etc. Group went to Black’s restaurant on Woodmont Avenue – Bethesda) for
drinks on the outdoor terrace (pretty cold).
We continue to have endless meetings with ASPR on the Medical Countermeasure
(MCM) review led by Nicki Lurie with Laura Petrou and Jenny Backus involved. I now
attend by conference call since it is a waste of time to go down town for these drawn out
discussions. Theme is post-mortem on the pandemic flu response and how do we
incorporate what Heidi Avery wants into the Secretary’s (HHS) MCM review. The
incompetence and amateurishness of HHS crew in general is noteworthy. I love Jesse
Goodman, but he just does not get it that the FDA is a major part of the problem; and he
is one of the very best FDA people.
April 17, 2010 – Was at the Georgetown Harbor near Thompson’s Boat House watching
Ali’s Varsity Crew Boat compete in a regatta. Nice Spring day on the Potomac. Chris
and I were with the usual parents group including our good friends Liz and David Hayes
whose daughter Molly is Ali’s “best” friend and boat-mate. Both will attend Stanford in
September. There had been a terrible explosion in an off shore deep-water oil rig a few
days ago with no apparent oil leak despite the fact that the platform was destroyed, 11
people died and scores injured. It was the British Petroleum (BP) Horizon Deepwater
well. David Hayes is the Deputy Secretary of the Department of the Interior. In the
middle of the regatta, David got a phone call from the White House communications
people. Apparently, there is considerable amount of oil leaking from a broken pipe line.
They were saying that the leak is minimal and David was caught in the middle in having
spoken to the press and saying that this was serious. The White House communications
people were concerned that he said that we have a bigger problem than exists. They were
apparently giving him some “shit” about this. David, who recently (last year) had a
cardiac arrest associated with a myocardial infarction on a golf course, looked shook and
distracted. I encouraged him to not worry about what the communications people think. I
know something about the WH trying to control the “message”. Little did either of us
know that over the subsequent months would unfold the worst oil spill in history and the
worst environmental disaster in the history of the USA.
Released by Chairman Rand Paul
232April 19, 2010 – Went to the Lasker Board of Directors dinner at the Citronelle
Restaurant in Georgetown at the invitation of Maria Freire. Sat next to Al Somer. Good
evening, but ridiculous situation where the government people (me, Peggy Hamburg,
John Gallin, Harvey Alter actually had to pay for our own meal due to misguided conflict
of interest rules.
April 21, 2010 – Continue to have weekly meetings in the Situation Room of WH led by
Heidi Avery. Continued frustration on Heidi’s part about the lack of cooperation on part
of Nicki Lurie and HHS. Heidi wants transformation and HHS is conservative, only
concerned about the Secretary, and “stuck in the mud”. What a sorry crew. These
meeting are started to take a toll on my schedule with having to take the METRO down
and back and the Red Line being barely functional with amazing slowness and frequent
mishaps.
April 27, 2010 – Another Sit Room WH meeting to discuss budget and implementation
of MCM initiative. Continued tension. I am with Heidi.
April 28, 2010 - Busy day. Two Congressional (House) Hearing in the Rayburn
Building: 1) Appropriation Subcommittee chaired by David Obey. I accompanied
Francis Collins along with Tom Insel (NIMH) and Griff Rogers (NIDDK) to testify.
Friendly Hearing but budget is depressing – flat. 2) in the late afternoon – House Energy
and Commerce Health Subcommittee Hearing on Antibiotic Resistance chaired by Frank
Pallone (D-NJ). Testified with Tom Frieden. Typical posturing back and forth between
Dems and GOPs about Health Care Reform (nothing to do with the subject of the
Hearing). We did well.
April 29, 2010 – ICD retreat - at the Cloisters. I spoke on the MCM initiative of the
WH and the NIAID role in this. Others spoke on translational research. Much of
meeting was on translational research. Clearly the NIH (under Francis) is heading in that
direction.
April 30, 2010 – Did Congressional Briefing on AIDS research sponsored by AMFAR at
the Rayburn Building. Susan Blumenthal chaired it. Also there was Wafaa El-Sadr.
May 1, 2010 –Went to Saturday Brunch gala at The Haddad/Greenberg residence at 4852
Hutchins Place, N.W. as a pre- WH Correspondence Ball function. Featured Susan
Axelrod of CURES (for epilepsy). Many of the usual DC glitterati, media and
Hollywood Stars there. Saw my old friend Dana Delaney and practically every media
person I know – David Gregory, Wolf Blitzer, Chris and Kathleen Matthews, etc.
May 2, 2010 - Annual McLaughlin (now together with Reuters) Sunday Brunch after the
WH Correspondents’ ball. Hel at the usual Rooftop of the Hay-Adams Hotel. Met with
and spoke with Dennis Quaid who is an advocate of eliminating “Hospital errors”. His
child was the victim of a medication error involving a heparin line through which the
infant was given 10,000 times the dose of heparin.
Released by Chairman Rand Paul
233May 5, 2010 – At his request, had meeting in my office with J. Craig Venter. He wanted
to brief me and get my advice on how to handle the rollout of his upcoming Science
paper on Synthetic Biology. He has made a major advance in synthesizing from the
sequence in a computer the 1.1 million base pairs of Mycoplasma mycoides and inserted
it into a Mycoplasma capricolum bacteria. The synthetic mycoides then began to code
for the proteins of the bacterial cell wall so that after several replications there was a
bacteria with a synthetic genome and all of the protein coded for by the synthetic
genome, thus a synthetic cell. I advised him to be very transparent at this and present it
to the NAS, the OSTP, among others. He has lined up some embargoed press in
anticipation of the release next week of the paper on May 13. He very much wanted me
to do heavy press with him likely to add a greater degree of credibility to it as well as
because I explain science so well. From today until the House Hearing on May 27, HHS
and the White House completely muzzled me for ridiculous reasons. Despite the fact that
John Holdren submitted my name to the WH as the best person to do TV, radio and print,
the WH muzzled all government comment on this. They were “afraid to elevate it
publicly by having well-known government figures speak about it since they did not want
flack from the “right” that the government was involved in “creating” life.
Unbelievable!! Rick Weiss who is communications director for OSTP is extremely
distraught about the muzzling. Of note, this has happened to me throughout the H1N1 flu
pandemic. Apparently, besides Jenny Backus, more importantly, David Pfeiffer at the
White House is now behind the muzzling.
May 6, 2010 – We have been pushing the issue of more resources and activity on
Neglected tropical Diseases (NTDs) here at NIAID. Peter Hotez from GW has been a
leader in this field. Recently, Zeke Emanuel at OMB has been pushing it as part of the
POTUS Global Health Initiative (GHI). Zeke called a meeting of all of the players in the
field including me, Hotez, Eric Goosby, Raj Shah (Head of USAID), Raj’s assistant Amy
Batson and many others to discuss the future agenda. The meeting involved research,
policy, implementation. NIAID will sponsor a purely scientific meeting later in the year
(Dec., 2010).
May 7, 2010 - “Big Think” meeting at the Natcher Building of Outside consultants to
discuss 3 of Francis’s pillars: 1) high throughput technology; 2) Translational Research;
3) Research involved in enhancing health care reform. All day. Francis Collins clearly is
trying to steer the NIH towards his themes. “Everybody wants to be somebody.” The
meeting was geared to figure out how to spend Common Fund Money and how to move
more towards translational research. Actually a good meeting. Francis is smart, very
hard working, but it is all about Francis.
May 13, 2010 – Gave Keynote at the NIAF Public policy Forum at the Rayburn
Building. Typical of similar Italian functions. Again, continual activity at WH with
MCM and Heidi.
May 14, 2010 – Phenomenal reception/dinner at the Academy of Achievement on 16th
Street, N.W. hosted by Wayne and Catherine Reynolds. Usual stars of DC were there:
Eric Holder, media people, Gen. James Jones, Bob Barnett, etc., etc. It was a Tribute to
Released by Chairman Rand Paul
234Hal David, master lyricists and team member with Burt Bacharach. “Mystery”
entertainers were B.J. Thomas singing “Raindrops keep falling on my head” and the
amazing Dionne Warwick. I helped Dionne a few months ago by referring her friend to
a neurologist for MS. We had a pleasant conversation after her performance.
May 18, 2010 – Science Management Working Group (SMRG) meeting in Building 31
to discuss the clinical center issues and the proposition to open it to the extramural
community in exchange for the inflationary increases being paid for out of the total NIH
budget instead of just the IRP budget. Still pending what the decision will be.
That night had dinner at Assaggi in Bethesda with Mark Harrington, Gregg Gonsalves
and David Barr to discuss the underfunding of PEPFAR and what to do about it. In this
regard, big issue looming among the international and national AIDS advocacy
community about the POTUS GHI that includes PEPFAR, but funds PEPFAR at almost
level instead of the expected increases by the community. POTUS wants to expand GHI
beyond just PEPFAR and include, child health, maternal health, women’s health, NTDs,
etc. Thus, PEPFAR is somewhat competing with others for a limited pot of money.
Many African health officials such as Peter Mugyenyi are openly complaining about this
and getting agitated. Obama is looking in the eyes of the activists as anti-AIDS, which he
is not. However, it is clear that AIDS is not his highest priority.
Earlier in the day I appeared on the Diane Rehm show on just this topic of short-
funding of PEPFAR. On with me was Stephen Lewis (former UN envoy at large for HIV
and Peter Mugyenyi and Eric Goosby. Lewis as usual was sanctimonious.
May 21, 2010 – Waxman’s House Energy and Commerce committee want me to testify
on May 27 with Craig Venter and others on synthetic biology and the science paper that
just came out. White House is balking. I spoke with staffers Naomi Seiler and Steve
Cha. Both really want me to testify.
May 25, 2010 – Received the Joel A. Toubin Award for Advocacy on Behalf of HIV
Infected People from the Whitman Walker Clinic at the Embassy of Sweden at 2900 K
street on the Georgetown Waterfront. Amazingly beautiful day. Reception on the
rooftop with panoramic views of the Potomac, Watergate, the Key bridge, etc. Check out
my speech
May 26, 2010 – Met with Francis Collins, Harold Varmus (recently announced as new
NCI Director, John Burklow (OC for OD), Kathy Hudson, and Pat White (Leg for NIH
OD) regarding the disturbing Administration policy of “muzzling” NIH and other
government scientists (see discussions above). Conclusion is that we must strongly
suggest to John Holdren (POTUS Science Advisor) that he directly tell the POTUS that
scientists, particularly at NIH are being muzzled by the WH and HHS communications
people.
Released by Chairman Rand Paul
235 The evening (beautiful, warm Spring DC evening) went to the Annual National
Education and Leadership Awards (NELA) Gala at the Omni-Shoreham Hotel given by
the Sons of Italy Foundation. Bill Clinton received the Lifetime Award for Public
Service. Came 1 hour late, but gave a great speech on public service. Also awarded was
Captain Anthony Odierno who lost his left arm to an RPG attack on his Humvee in
Bagdad. His father General Raymond Odierno introduced his son. Tear-jerker for sure.
Also awarded was Lewis Merletti, former WH Secret Service detail and ultimately Chief
of the Secret Service; decorated Viet Nam vet (Bronze Star). Patty Conrad knew him
when she worked in the Bush 41 WH. Says he was a very nice person. Sat at the table
with Bob Gallo and Phil Piccigallo. It is interesting that after all these years I have
become somewhat of an icon to the older and younger Italian men and women, many of
whom wanted their picture taken with me.
White House finally clears me to testify tomorrow
May 27, 2010 – testify before House Energy and Commerce Committee on synthetic
biology related to the Science paper by Venter et al on the synthesis of Mycoplasma
mycoides and insertion into a Mycoplasma capricolum to ultimately have a totally
synthetic bacteria. Testified with Craig Venter, Jay Kiessling (Berkley), Greg Kraebnick
(Hastings), Drew Endy (Stanford). Hearing went extremely well. Some posturing by
GOPs on Health Care reform, but in general, we all did very well.
June 5, 2010 – Met with Rick Klausner at my house for catch-up. He is in town to meet
with OSTP regarding preparedness issues similar to the types that I have been working on
with Heidi Avery.
June 8-11, 2010 – Visited RML for the BSC review. Went with Patty Conrad, Kathyu
Zoon, Karyl Barron etc. Had very nice time. Went fishing twice with Marshall Bloom
and Patty and a great guide named Jack Mauer. Fishing not good due to high water from
rain. Nonetheless, it was a wonderful time.
June 12, 2010 – Flag day at NCS. Alii took the Science, Math and Spanish Prizes. She
would have won the Flag (for highest GPA over 3rd and 4th year) but an English teacher
who is a known asshole gave her an A-.
June 13, 2010 – Graduation Day at NCS. Feeling very sad that my baby (Ali) will be
leaving us for Stanford in the Fall.
June 15, 2010 – Had dinner at the home of the Italian Ambassador to the USA (Villa
Firenze – 2800 Albermarle Street, N.W.) I wanted to do this since he is the new
ambassador and I have over the years become variably friends with the Ambassador. The
previous one was Giovanni Castanaletta. The current one is Giulio Terzi di Sant’Agata.
I was fortunate enough to sit next to him at the dinner table and so got to know him.
Spoke about a wide variety of subjects from Afghanistan to the Oil spill in the Gulf of
Released by Chairman Rand Paul
236Mexico to the economy to science in Italy versus the USA. Very nice guy. Also at the
dinner were Bob and Mary Jane Gallo, Susan Blumenthal and a bunch of Italian Pharma
people and diplomats.
June 17, 2010 – Met with Minister of Health of Taiwan today to discuss potential
scientific collaborations. He said that I was “famous” in Taiwan….interesting. Jean
William (Bill) Pape visited from Haiti today and gave lecture at Masur Auditorium. He
is a good friend and invited Megan to visit Haiti. He is in DC to receive an award for the
amazing work that he has done in Haiti related to the earthquake.
June 24, 2010 – Met with Minister of Health of India Ghulam Nabi Azad to discuss
collaborations. Sharp guy – enjoyed discussion.
June 29, 2010 – Went with Chris to South Lawn of the White House to celebrate her
election to the Bioethics Commission. Turned out it was a massive get together on a very
hot day for all Presidential appointees. They were completely disorganized in getting
people cleared through the gates and it was a logistic disaster. The delay was probably
related to multiple checking of IDs related to the “gate-crashing” of a WH party a few
months ago.
July 11, 2010 – Went to Atlanta for the day (Sunday) to give plenary at the CDC
sponsored international Conference on Emerging Infectious Diseases. Hot July day. I
shared the Plenary opening evening addresses with Tom Frieden and Kevin DeCock.
Good camaraderie among CDC people and me. Came back to DC that night.
July 12, 2010 - Attended swearing in of Harold Varmus as the new Director of the
National Cancer Institute. Starting to do a lot of press in anticipation of the International
AIDS Meeting in Vienna next week. Am looking forward to this meeting since I am
giving a Plenary Lecture on Pathogenesis of HIV Disease: Opportunities for
Interventions.
July 18, 2010 – Leave for Vienna (Sunday) – Disaster for travel – flight cancelled on the
runway, switch from direct flight to Vienna (Austrian Airlines) to United to Frankfurt
connecting to Vienna. United flight sits on IAD runway for 2 hours due to thunder
storms – miss connection in Frankfurt. Finally get the Vienna on Monday afternoon
(19th July). Trying to stay cool and un-ruffled. Good to have Johanna McDonough meet
me at airport. She had rescheduled me from IAD to get me to Vienna. She is a life-
saver.
July 19-21, 2010 – Really great meeting in Vienna. My talk was a knockout. Also, very
good press from Vienna – PBS Newshour, CNN, WTOP, CBS radio, also NY Times,
Washington Post, etc. Meeting was a complete success. We announced the results from
the CAPRISA microbicide trial. First success with topical microbicides.
July 22-23, 2010 – Good press follow-up from meeting – NPR Science Friday among
others. Note that we have been going through a record breaking heat wave on the East
Released by Chairman Rand Paul
237Coast with a concentration in DC. Temps between 92 and 101 F for the past several
weeks. Welcome to Washington!
Also, over the past 2 weeks I have been informed that I have won the Paul Janssen
Prize from Belgium ($100,000.00) (cannot take the money since the prize is sponsored by
J & J – what bullshit). Also won the Will Roger Prize for $50,000.00 (yes, I can accept
the money). To be given to me in LA – am looking forward to this.
This has been a very busy, hot, exciting summer. Am chronically tired, but good things
are happening, particularly in the lab (a4B7) and with commentary papers that I am
writing including some really nice ones with Gary Nabel on HIV vaccine and universal
flu vaccine.
Aug. 4, 2010 – Memorial service for Bob Chanock, giant in virology for 50 years at
NIAID. Major figure in virology
research – discovered M. pneumonia; several parainfluenza viruses, his groups also
discovered norovirus (Norwalk agent), made vaccine for rotavirus and hepatitis A, etc. I
gave one of the eulogies at his service.
Aug. 5, 2010 – Dinner with Larry Corey who has just been offered and accepted
President and CEO of the Fred Hutchinson Cancer Research Center in Seattle, where he
has worked for many years. Big career decision regarding his future role in helping lead
the HIV vaccine effort as PI of the HVTN.
Aug. 18, 2010 – Big controversy regarding the conflicting studies of the role of XMRV
(xenotropic mouse leukemia virus-related virus) in chronic fatigue syndrome (CFS). 2
papers coming out almost simultaneously from FDA (Shy-Ching Lo)/NIH (Harvey Alter)
in PNAS and the CDC in Retrovirology. FDA/NIH finds correlation (86% vs 8.% in
normals), while CDC finds no correlation. I have been involved in trying to get to the
bottom of this prior to publication of the discordant results since we knew of the data
before the papers were published. I believe that the FDA/NIH study is contaminated and
I do not believe Shy Lo since in the late 1980s he had claimed with what appeared to be
fool-proof data that AIDS was associated with a new species of mycoplasma (M.
fermentans) as a co-factor. The data proved to be spurious,, but people seem to have
forgotten about this. I have convinced Ian Lipkin from Columbia (Mailman School of
Public Health) to referee coded sample examination of FDA looking at negative samples
from CDC study. The exercise was somewhat inconclusive. Lo does not want to do
another study starting with identical CFS samples that are coded together with known
normals and known spiked samples to really settle this. The issue is that highly
emotional CFS crowd now wants to treat CFS people with anti-retroviral drugs, despite
no evidence of causality and several negative studies besides the CDC study.
Aug. 19, 2010 – Finally had formal roll-out of the Medical Countermeasure (MCM)
review and initiative together with PCAST Report re: 2009 pandemic flu. Roll-out was
at HHS led by Secretary Sebelius. I presented the NIH component of the 5 part initiative
which is the Concept Acceleration Program (CAP) and the Strategic Investment (SI)
program (a 501 3(c) similar to a venture capitol firm). Other initiatives were regulatory
Science for FDA, manufacturing capacity, enhance influenza capability (potency assays,
Released by Chairman Rand Paul
238sterility assays, etc.). All of this evolved greatly from the many meetings that we had
over the past year in the White House Situation Room with Heidi Avery. We finally
came to some compromise in the tension between the WH (Avery) and HHS (Lurie-
Sebelius).
Nov. 2, 2010 – Mid-term Elections! In a strong repudiation of what some consider the
over-reaching liberal policies of President Obama, the Republicans take of the House by
winning 60+ seats and lick up many in the Senate. Pelosi out as Speaker and John
Boehner (R-Ohio) in. Much upheaval with some Tea Party Candidates winning seats.
Nov. 8, 2010 – Visited Holy Cross College to deliver the Inaugural Joseph E. Murray,
M.D. Distinguished Lectureship in Medicine. Joe Murray (class of ’40) had won the
Nobel Prize for performing the first kidney transplant. I gave the lecture to a full house
at the Hogan Campus Center at Holy Cross in Worcester. Write-ups in Boston Globe and
Worcester Telegram. Old friends came to see the lecture from my class of 1962 – Bob
(and Peggy) Curran, Jim Mulvihill, Pete Deckers. Best part of the evening was the
appearance (stayed for dinner and the lecture) of Bob Cousy who had said that he was so
proud of what I had done for the country and the world that he wanted to come to meet
me and hear my lecture. He was attentive and engaged for the entire lecture in the first
row. During the day before the dinner and lecture, I met for hours with students (almost
all pre-med and mostly women). They were great and we had fun. They said that I was
“cool” and “awesome”
Nov. 23-24, 2010 – Big advance in HIV prevention research. The iPrEx study results for
pre-exposure prophylaxis (PreP) for prevention of HIV infection in MSM came out on
11/23/10 in the NEJM showing 44% decreased risk in Truvada arm versus placebo.
Importantly, for those who took the drug 90% or more of the days, decreased risk was
73%. For those with blood levels of Truvada vs those without blood levels, the risk was
decreased by 92%. Big media days for me – Front page of NY Times, CNN Situation
Room with Suzanne Malveaux, multiple print medias, Canadian and European TV, Local
Fox News, several NPRs including “Talk of the Nation”; The NewsHour. This will be an
important addition to the toolkit of prevention methods.
Megan spending the first semester of 3rd Year in Morocco. Somewhat stressful, but
extraordinary experience. She is an amazing young woman. I am actually in awe of her
courage and adventurous spirit.
Dec. 1, 2010 – World AIDS Day – Gave presentation at The White House and
participated in panel led by Eric Goosby together with Chris Collins, Ada Adamora,
Jennifer Cates. My thene was 1) Optimizations of Therapy; 2) Go for a cure; and 3)
Maximize prevention.
Dec. 1, 2010 through Jan. 19, 2011 – In general, nothing overwhelming. Economy
recovering; still strident partisanship in Washington, D.C. Health care reform passed,
and no Republicans voted for it – amazing. NIH budget looking bad.
Released by Chairman Rand Paul
239Dec. 8, 2010 – Science Management Review Board (SMRB) of NIH (of which I am a
member) has been and continues to discuss Francis Collins’ intention of merging NIDA
and NIAAA, dissolving NCRR, as well as and more importantly creating a National
Center for the Advancement of Translational Science (NCATS) at NIH to include the
CTSAs and CAN RAID TRND and Molecular libraries. Francis is dead set on starting a
new center and is using the SMRB to endorse it. I have made it clear that I do not think
that this is a good idea since it is redundant (nothing broke). Also, bad idea at a time of
flat, if not decreasing, NIH budget.
Dec. 9, 2010 – Major breakthrough in NIH prevention with the results of the PrEP study
(iPrex) showing that daily Truvada to uninfected MSM decrease acquisition of HIV
infection by 44% and in those who take the meds every day, it decreases acquisition by
90%. I did much media on this
Dec. 13, 2010 – Major outbreak of Cholera in Haiti. Traced to contaminant of a river
(used for drinking and washing in rural part of Haiti) by UN Nepalese soldier with
asymptomatic cholera. I appear of Diane Rehm show discussing cholera.
Dec. 17, 2010 – I deliver the Walter Dzau lecture at Brigham and Women’s Hospital
(invited by Paul Farmer) on “30 Years of HIV/AIDS: A Personal Journey”.
Overwhelming hit with prolonged applause. I spoke of my involvement from first day
and told the story of the “Birth of PEPFAR”.
Jan. 14, 2011 – Appeared on Anderson Cooper 360 on CNN in NYC for a special on “30
Years of AIDS”. There will likely be increasing media events this year since this is
indeed the 30th Anniversary of the recognition of AIDS.
Jan. 15-16, 2011 – Was Keynote Speaker at a Keystone Meeting in Vancouver, BC on
Tuberculosis. Large (~800) audience, mostly post-docs. Very well received.
Feb. 15-16, 2011 – Went to San Juan to deliver the Opening Keynote at the
NIAID/CDC/PAHO-sponsored Dengue Symposium. Great time. In accordance with my
expanding to more emphasis on Global Health and Emerging Diseases.
Feb. 24-26, 2011 – Parents’ Weekend at Stanford. Absolutely wonderful time to see Ali
in her beautiful school setting. Spent prior night in SF with Chris at the Queen Anne’s B
& B and went to Jackson-Fillmore Restaurant. Days at Stanford were great. Saw
women’s basketball team clinch the PAC -10 championship for the 11th year in a row by
defeating Oregon. Also, saw #1 ranking woman tennis player (Barte) and men’s
volleyball (ranked 4th in Nation).
Mar. 7, 2011 – Town Hall meeting for non-HIV clinical trials network. Sensitive issue
in that Carol Heilman still is not enthusiastic about it. However, I made it clear exactly
what we are going to do.
Released by Chairman Rand Paul
240Mar. 9, 2011 – Gave opening lecture at NTD Workshop at Natcher Building. Continue
to stress Global Health.
Mar. 15, 2011 - White House communications people at it again. Last week (Mar. 11,
2011) a terrible tragedy hit Japan with a 9.0 scale earthquake in the NE part of the
country almost immediately followed by perhaps the worst tsunami in recorded history of
Japan destroyed much of the NE Coast. Importantly, it knocked out the cooling system
of the Fukushima Daiichi Atomic Power Plant leading to multiple explosions and
meltdowns with radiation spillage and leakage. As of today (4 days later) the extent of
the potential disaster is still not known, i.e. how much radiation exposure will occur.
Thus, we (NIH and me personally) are getting the expected calls from the press regarding
the medical aspects of acute radiation syndrome (ARS) – what it is and how you treat it.
The White House is not granting any clearances for me or anyone at this point to talk to
the Press. Amazing!! Same as with the Pandemic Flu early on.
Mar. 21, 2011 – Was invited by the Bush family to a Kennedy Center event which was
“The Points of Light Institute TRIBUTE – All together Now – A Celebration of Service”.
Bush 41 sent me a hand-written note thanking me for my meager $150.00 donation. At
the event were Presidents George H.W. Bush, George W. Bush, Jimmy Carter and Bill
Clinton. Clinton gave an amazingly moving talk about his friendship and love of Bush
41. Entertainment was terrific: Garth Brooks, Kid Rock, Cee Lo Green, Carrie
Underwood, Darius Rucker, among others. Brought back very fond memories of my
interactions with Bush 41 as well as other Presidents during the past 30 plus years.
Mar. 29, 2011 - Appeared on the Colbert Report. Great success! Had a great time and
received hundreds of e-mails and calls and personal mention of how good the
performance was. Reason for the appearance was the approaching 30th anniversary of
first cases of AIDS.
April 7, 2011 – Gave World Health Day remarks at PAHO for Secretary Sebelius.
April 10, 2011 – Dinner at Mark Dybul and Jason Claire’s home at 1340 Wallach Place,
N.W. with Tom Sietsema (Washington Post Food Critic), Zeke Emanuel, Chris, etc.
April 12, 2011 – Gave Solomon Berson Lecture at Mt. Sinai in NYC – “30 Years of
HIV/AIDS: A Personal Journey”. Got prolonged standing ovation. Will be stressing
this in coming weeks as we approach June, 2011
April 15, 2011 – Went to Charlottesville, VA to see Danny Hultzen pitch against Duke.
He was great. 7 innings shutout.. ERA now 1.19. Sure thing for 1st Round MLB draft
pick
May 1, 2011 – Navy Seal Unit 6 kills Osama Bin Laden in a compound right next to a
Pakistani Military base is Abbottabad. Big rift now between USA and Pakistan sine we
believe they were either incompetent or knew all along where he was.
Released by Chairman Rand Paul
241May 11, 2011 - Senate Appropriations Subcommittee Hearing for the 2012 NIH budget.
Really bad budget times with the feeling that we are doing really well with only a 1.9%
increase from 2011 for the PB. Republicans (most Tea Party people) trying to cut
discretionary spending back to 2008 level, which would be devastating for NIH. Francis
Collins trying to push the NCATS (National Center for Advancing Translational
Science). I think this is a big mistake (“everybody wants to be somebody”). This is no
time to initiate this, but some of the pols, some in the scientific community who are
clueless, and others think this is a good idea. Harold Varmus and I have grave
reservations about this (me particularly) since I believe that it will have the unintended
consequence of sucking money away from standard NIH research to out into a Center
that is Francis’s baby. We are already doing $6 Billion in translational research at NIH.
May 12, 2011 – Big announcement of early stopping of HPTN 052, which is randomized
trial among 1763 heterosexual discordant couples to see if immediate treatment with
ARVs (350-550 CD4 counts) versus delayed treatment (wait until fall to 250 or AIDS-
defining illness) has an effect on transmission. Overwhelming response. 27 infections
in delayed arm and 1 transmission in immediate arm (p <0.0001). I held press briefing
and got front page in all major papers – NY Times.Wash Post, WSJ; appeared on NBC
Nightly News, CBS Evening News, CNN International, etc.
May 17, 2011 – The press, scientific, public health and general public interest in the
HPTV-052 results in becoming huge. I appeared on New Hour (interviewed alone by
Ray Suarez) as well as NBC Today Show. Have done taped interviews with Mark
Schoofs that will appear on the Website of WSJ.
May 18-26, 2011 - Much activity and interest (real buzz) on part of global activists to
use the 052 data to pressure the USA (Obama and USAID/PEPFAR) to increase funding
and re-prioritize the emphasis on treatment since it is also prevention as well as emphasis
those prevention modalities that have been scientifically proven to work such as
circumcision (which is now effective at 68% at 40 months into the follow-up study in
Rekai, Uganda). I am speaking mre openly on interview about pressing the
administration to give more money. Feels like the old days of the beginning of PEPFAR
when OMB ridiculed me for asking for so much money and then everything broke lose
with PEPFAR.
On May 26, I met at the headquarters of the WH Office of the Global AIDS
Coordinator (OGAC) with Eric Goosby, Reinhard Schwartzlander (UNIADS), Carl
Dieffenbach, Tom Frieden (by phone), Debbie Birx (CDC- GAP Prgram), people for
USAID, and State. I made the argument that there is an elephant in the room and that is
that we MUST put more resources into treatment since we now know that it is in fact
prevention and we will either pay now or pay more later. Eric Goosby was so pleased
that I backed what he really wants and needs but since he is a POTUS appointee, he
cannot be too up front about. See below his email of May 26, 2011 to me after the
meeting:
Released by Chairman Rand Paul
242Tony:
You achieved what we needed for OMB and State leadership get a feel of the
breakthrough and the context of the O52 findings, largely due to your clarity , candor and
authenticity… thanks my friend
Eric
PERSONAL
This email is UNCLASSIFIED.
May 27, 2011 – Taped interview with the WSJ appeared today . Long and excellent
interview.
May 29, 2011 - My Editorial appeared in the Sunday Opinions Section of the
Washington Post entitled “30 Years of AIDS”. Many people e-mailed and called about
it. Again, the momentum building up about a change in paradigm to support universal
voluntary testing and universal access to treatment and care.
May 31, 2011 - Delivered lecture at NIH on “30 Years of HIV/AIDS: A personal
Journey” in Masure Auditorium. It likely was the most widely attended lecture in NIH
history. Julie Marquardt ()NIAID) kept track. The attendance completely filled Masur
Auditorium (492 people), overflow completely filled Lipsett Auditorium (260) and 1130
people watched on Webcast. In total, 1947 people watched the presentation live, either
in person or via webcast.. Incredible amount of attention to the 30th Anniversary. As I
have said, the press attention to me and my field varies from intensity to very low levels.
This is one of the periods of extreme intensity.
June 1, 2011 – Took Amtrak to NYC to give Commencement Address at Albert Einstein
College of Medicine Commencement at Lincoln Center. Incredibly hot and sunny day in
NYC and DC – up to mid-90s. Came back home to find the air conditioning in my
house broke – Oy!
June 2-5, 2011 – Press interest continues. Was on NBC Nightly News on June 5 and
Fox Local News as well as Canadian Broadcasting System (CBC)
Also, big outbreak of Shiga-Toxin producing E.Coli (STEC) diarrhea and Hemolytic
Uremic Syndrome in Germany and other countries in EU related to contamination of
bean sprouts. >1600 people affected with ~600 HUS and 22 deaths. Was on BBC with
Katty Kay discussing this.
June 6, 2011 - Had my BSC review for LIR. Rating was “Outstanding” all around.
June 7, 2011 – Much activist activity brewing regarding the upcoming UN Special
Session on AIDS this week. Funding countries are refusing to commit to putting up the
resources to get 13 to 15 million people on treatment by 2015. On the basis of HPTN -
Released by Chairman Rand Paul
243052 (see above) I have been arguing forcibly that we need to make the investment now or
else not only will lives be lost, but we will have to pay more later for the infections that
we could have prevented. See my interview published today in Nature with Erika
Check Hayden
Drug treatment for HIV infection is effective in preventing its spread, but implementing
this fully will require more resources, says leading NIH scientist.
Erika Check Hayden
Anthony FauciBloomberg News/Landov/Photoshot
This week, political leaders meet in New York for a United Nations summit that will
frame the ongoing fight against HIV/AIDS. The conference comes a decade after the UN
meeting at which heads of state committed the first major funding to the battle; as a
result, 6.6 million people are now receiving antiretroviral drug therapy to keep their HIV
infection under control — 22 times the number in 2001, according to estimates by the
Joint UN Programme on HIV/AIDS (UNAIDS).
But 9 million people who need treatment are still not getting it, and global economic
woes threaten to weaken international AIDS programmes. Anthony Fauci, head of the US
National Institute of Allergy and Infectious Diseases, explains what scientists hope the
UN meeting will achieve.
How is the research landscape different going into this meeting than it was a decade
ago?
A considerable number of people have been put on therapy. But for every person who
goes on therapy, two or two-and-a-half people get newly infected, so there's been this
question of the balance between treatment and prevention.
A real game changer occurred just a few weeks ago with the clear demonstration in
heterosexual couples that when you start treatment earlier rather than later, you not only
benefit the person infected, but that person is also 96% less likely to transmit the virus to
Released by Chairman Rand Paul
244their uninfected partner than if they were not treated (see 'HIV treatment shown to
prevent spread of virus'). So people can say with a good deal more confidence that
treatment is prevention.
What does that imply for global AIDS policy?
We have now so many types of prevention in our armamentarium, including treatment.
So rather than have the tension between treatment and prevention, as there was
previously, let's try to seek out, test, and treat as many people as we possibly can, because
when you treat people, you are doing prevention. So that brings up the big question —
which is that it's going to require a lot of resources.
How do you frame that question?
The fundamental policy decision is: is it better to make investments now, even with the
restricted resources we have available, and slow down or even get control of the
pandemic, rather than not making the investment now, and only having to pay down the
line, and possibly paying more.
The UN wants countries to commit to treating 13 million people by 2015 at a cost of $22
billion, but this would not even treat all the people who will need it by that time. Is this
where we should aim, given what we know about treatment as prevention?
It's a reasonable goal. The issue at hand — the big elephant in the room — is are the
parties responsible able to come up with the resources to make this happen? We have a
confluence of enormous opportunity to turn around the global pandemic at the same time
that we have an almost unprecedented constraint on resources. This is going to be the
subject of some serious discussion in New York. Despite the constraints on resources, we
have a real opportunity not only to save a lot of lives, but in the long run, to save money.
Many researchers are now saying that we have the tools needed for effective
prevention, and social phenomena are the main obstacle to slowing the spread of
HIV (see Comment: ' Stigma impedes AIDS prevention'). What more can
researchers do to solve this problem?
It isn't as if we're going to be able to access every individual immediately, but there are
programmes that can be enhanced that will allow us to penetrate into those areas of
society that have been difficult to reach. Can we do this tomorrow? No, but we don't have
to. We can start doing it over the next couple of years and we'll get better and better at it.
What are researchers looking for out of the meeting?
What I'm going to do in New York is put the data on the table. There's no more doubt that
treatment can serve as prevention. My purpose is to say to policy makers: here are the
data; you have to make up your mind about whether you want to implement the
Released by Chairman Rand Paul
245programmes that have been proved to work — to make it almost scientifically obvious to
them what they need to do.
June 8 – July 1, 2011 - Much activity and excitement around my coming out publicly
pushing for more resources for expanded treatment and prevention for global HIV/AIDS.
The activist community is delighted. I will past in below the editorial that I wrote in
Science that was published by agreement with the Science editors to be ready for the
International AIDS meeting in Rome as well as the note that Gregg Gonsalves sent to his
list-serve (every activist in the world) regarding my note.
Science 1 July 2011:
Vol. 333 no. 6038 p. 13
DOI: 10.1126/science.1209751
EDITORIAL:
AIDS: Let Science Inform Policy
1.Anthony S. Fauci
+ Author Affiliations
1. Anthony S. Fauci is director of the National Institute of Allergy and Infectious
Diseases, U.S. National Institutes of Health, Bethesda, MD.
1. E-mail: [email protected].
CREDIT: NIH
Thirty years have passed since the first cases of acquired immune deficiency syndrome
(AIDS) were reported by the U.S. Centers for Disease Control and Prevention. How does
this anniversary compare to the 20th or the 10th? The differences are considerable,
because we now have an unprecedented opportunity, based on solid scientific data, to
control and ultimately end the AIDS pandemic.
Released by Chairman Rand Paul
246More than 60 million people have been infected with human immunodeficiency virus
(HIV) worldwide. More than 30 million have died, and 34 million are currently living
with HIV infection. In 2009, the most recent year for which data are available, 2.6
million people became newly infected. The burden of HIV/AIDS is overwhelmingly felt
in resource-poor countries, especially in sub-Saharan Africa, which are least equipped to
deal with the disease. Although the toll is staggering, the scientific progress in HIV/AIDS
research over 30 years has been extraordinary, particularly in the development of
antiretroviral therapy (ART), which has proven to be life-saving to many millions.
CREDIT: FOTOSEARCH
For decades, the idea of ending or even controlling the pandemic was a distant aspiration
because we lacked sufficient evidence-based tools to convert the hope to reality. At this
30th anniversary, the situation has dramatically changed: We finally have scientifically
validated prevention modalities that clearly work, suggesting that ending the pandemic is
feasible. Older, proven prevention tools include the proper use of condoms, needle
exchange programs for injection drug users, and antiretroviral treatment of HIV-infected
pregnant women to prevent transmission of the virus to their newborn infants. Building
on this foundation, recent HIV prevention research also has provided strong scientific
evidence that adult male circumcision is highly effective in preventing infection in
heterosexual men, that an antiretroviral-based topical gel prevents infection in
heterosexual women, and that pre-exposure prophylaxis with ART in men who have sex
with men is effective at preventing infection. And in May 2011, a randomized controlled
clinical trial demonstrated that early initiation of ART by the infected partner in
heterosexual couples, where one partner is HIV-infected and the other not, is highly
effective in decreasing transmission of HIV to the uninfected partner.
The fact that treatment of HIV-infected adults is also prevention gives us the
wherewithal, even in the absence of an effective vaccine, to begin to control and
ultimately end the AIDS pandemic. Of course, the development of an AIDS vaccine
would be the ultimate game-changer, and efforts toward this goal are intense. However,
the existing armamentarium of scientifically proven interventions immediately offers an
unprecedented opportunity to make major gains in the fight against HIV/AIDS. Global
implementation of HIV interventions, including scale-up of the delivery of ART, must be
accelerated, and this will be costly. Certainly, there are many competing priorities for
scarce resources in the global health arena, such as other infectious diseases, maternal
Released by Chairman Rand Paul
247and child health, and tobacco control. But if one accepts the tenet that science should
inform policy, then the scientific data are speaking loud and clear. Global policy-makers
must seriously consider these new data in their priority-setting and decision-making.
Last month, world leaders at the United Nations General Assembly Meeting on AIDS
called for providing ART for 15 million people in low- and middle-income countries by
2015, an increase from the 6.6 million currently receiving therapy, plus additional efforts
toward universal access to HIV prevention, treatment, and care. An estimated $22 billion
to $23 billion annually will be needed by 2015; current spending is approximately $16
billion. Such targeted investments could prevent 12 million infections and 7.4 million
AIDS-related deaths by 2020. For the first time in the history of HIV/AIDS, controlling
and ending the pandemic are feasible; however, a truly global commitment, including
investments by those rich and middle-income countries whose contributions have thus far
been limited, is essential. Major investments in implementation now will save even
greater expenditures in the future; and in the meantime, countless lives can be saved.
July 1, 2011 – E-mails from Gregg Gonsalves:
-----Original Message-----
From: Gregg Gonsalves
Sent: Friday, July 01, 2011 6:55 AM
To: Fauci, Anthony (NIH/NIAID) [E]
Subject: Brilliant Science Piece
I think it will go down as one of the most important pieces written in
these past 30 years. It will either begin a new push to vanquish the
disease from the Obama Administration and other world leaders, or seen
as Cassandra's last warning, where even despite the science, the
evidence, the world turns their back on this opportunity.
g
--
Gregg Gonsalves
-----Original Message-----
From: Gregg Gonsalves
Sent: Friday, July 01, 2011 7:22 AM
Subject: Fauci in Science: Ending the Pandemic is Feasible
http://www.sciencemag.org/content/333/6038/13.full (scroll down for
text) This is one of the most important pieces to be written on
HIV/AIDS in a very, very long time. Dr. Fauci is a cautious scientist
and for him to step out so publicly, so unequivocally in this way,
Released by Chairman Rand Paul
248particularly when he works for an Administration, which is unlikely to
heed his words, is a tremendous statement of moral and political
courage.
I am not quite sure what we do now here to ensure that Tony's words
aren't just a call-in-the-wilderness.
The big AIDS organizations in the USA don't have the inclination or
even the ability to take on the President or the Congress. Both
branches of government know we're a paper tiger: a movement with a few
loud voices, a few people willing to put their bodies on the line, but
with little ability to affect their political lives. Unless the big US
AIDS organizations step up at this moment they will continue their
march into irrelevance for history. They can continue to issue press
releases about how much the President has done and continue to kiss the
ass of those in power, but that makes them sycophants, not leaders.
The rest of us have to get to work: we need to mobilize and get our
governments to make a new, substantial and sustained commitment to
HIV/AIDS, to TB, to maternal and child health, to global health. We
need to meet with parliamentarians, legislators, ministers and mayors.
We need to write in our local papers about what Tony's words mean now
for us: we can end this epidemic or beat it back deep into the corner.
This is our year. The legacy we leave behind will either be our
victory or an epidemic without end, passed down to our children and our
children's children, a plague upon their houses.
Gregg
Science 1 July 2011:
Vol. 333 no. 6038 p. 13
DOI: 10.1126/science.1209751
EDITORIAL
AIDS: Let Science Inform Policy
Anthony S. Fauci
Anthony S. Fauci is director of the National Institute of Allergy and
Infectious Diseases, U.S. National Institutes of Health, Bethesda, MD.
E-mail: [email protected].
Thirty years have passed since the first cases of acquired immune
deficiency syndrome (AIDS) were reported by the U.S. Centers for
Disease Control and Prevention. How does this anniversary compare to
the 20th or the 10th? The differences are considerable, because we now
have an unprecedented opportunity, based on solid scientific data, to
control and ultimately end the AIDS pandemic.
More than 60 million people have been infected with human
immunodeficiency virus (HIV) worldwide. More than 30 million have died,
and 34 million are currently living with HIV infection. In 2009, the
most recent year for which data are available, 2.6 million people
became newly infected. The burden of HIV/AIDS is overwhelmingly felt in
resource-poor countries, especially in sub-Saharan Africa, which are
least equipped to deal with the disease. Although the toll is
staggering, the scientific progress in HIV/AIDS research over 30 years
has been extraordinary, particularly in the development of
antiretroviral therapy (ART), which has proven to be life-saving to
many millions.
For decades, the idea of ending or even controlling the pandemic was a
distant aspiration because we lacked sufficient evidence-based tools to
convert the hope to reality. At this 30th anniversary, the situation
Released by Chairman Rand Paul
249has dramatically changed: We finally have scientifically validated
prevention modalities that clearly work, suggesting that ending the
pandemic is feasible. Older, proven prevention tools include the proper
use of condoms, needle exchange programs for injection drug users, and
antiretroviral treatment of HIV-infected pregnant women to prevent
transmission of the virus to their newborn infants. Building on this
foundation, recent HIV prevention research also has provided strong
scientific evidence that adult male circumcision is highly effective in
preventing infection in heterosexual men, that an antiretroviral-based
topical gel prevents infection in heterosexual women, and that pre-
exposure prophylaxis with ART in men who have sex with men is effective
at preventing infection. And in May 2011, a randomized controlled
clinical trial demonstrated that early initiation of ART by the
infected partner in heterosexual couples, where one partner is HIV-
infected and the other not, is highly effective in decreasing
transmission of HIV to the uninfected partner.
The fact that treatment of HIV-infected adults is also prevention gives
us the wherewithal, even in the absence of an effective vaccine, to
begin to control and ultimately end the AIDS pandemic. Of course, the
development of an AIDS vaccine would be the ultimate game-changer, and
efforts toward this goal are intense. However, the existing
armamentarium of scientifically proven interventions immediately offers
an unprecedented opportunity to make major gains in the fight against
HIV/AIDS. Global implementation of HIV interventions, including scale-
up of the delivery of ART, must be accelerated, and this will be
costly. Certainly, there are many competing priorities for scarce
resources in the global health arena, such as other infectious
diseases, maternal and child health, and tobacco control.
But if one accepts the tenet that science should inform policy, then
the scientific data are speaking loud and clear. Global policy-makers
must seriously consider these new data in their priority-setting and
decision-making.
Last month, world leaders at the United Nations General Assembly
Meeting on AIDS called for providing ART for 15 million people in low-
and middle-income countries by 2015, an increase from the 6.6 million
currently receiving therapy, plus additional efforts toward universal
access to HIV prevention, treatment, and care. An estimated $22 billion
to $23 billion annually will be needed by 2015; current spending is
approximately $16 billion. Such targeted investments could prevent 12
million infections and 7.4 million AIDS-related deaths by 2020. For the
first time in the history of HIV/AIDS, controlling and ending the
pandemic are feasible; however, a truly global commitment, including
investments by those rich and middle-income countries whose
contributions have thus far been limited, is essential. Major
investments in implementation now will save even greater expenditures
in the future; and in the meantime, countless lives can be saved.
--
Gregg Gonsalves
Released by Chairman Rand Paul
250--
Gregg Gonsalves
July 16-22, 2011
Gave Plenary Address at the IAS Meeting in Rome on “30 Years of HIV/AIDS: A
Scientific Journey and Look to the Future”. I emphasized at the end that “Science
should inform policy” as per my recent Science Commentary. I received a prolonged
ovation from the crowd of >4000. Clearly one of my best plenary talks ever.
Aug. 4, 2011 - During a trip to NYC to give a lecture at Columbia on “30 years of
HIV/AIDS: A Personal Journey”, Ian Lipkin arranged a closed pre-screening of the new
movie :Contagion” at the Warner Brothers headquarters in NYC. Ian served as the
technical advisor and wanted to get my take on the movie. Also at the screening were
Sanjay Gupta (CCN), the dean of Columbia Mailman School of Public Health, the
Commissioner of Health of NYC and other notables. The press asked me my opinion,
which was that it was an excellent film that was quite accurate scientifically. I was
widely quoted in blogs about this.
August 23, 2011 - Unusual experience – 5.9 Richter Scale earthquake hit Mineral, VA
with severe shaking of Building 31 such that some of my plaques fell off of the shelves.
Shock was felt as far North at Cape Cod. Jenny, Ali and Denise and Jack were in NYC
and they felt it.
August 226, 2011 – Washington, D.C. hit by Hurricane Irene that went up the entire east
coast. Much damage. We were lucky in that although many trees came down, our
house and cars were spared. However, I stayed up until 4:00AM nervously looking out
the window at the large oak tree in my back neighbors yard whose branches were
shaking violently. Importantly, I was very concerned about the 2 giant tulip poplars that
are in my front yard whose branches were also shaking wildly. Luckily we made it
through the night. Storm also hit NYC where Jennifer is living.
Amazing coincidence that during the same week in DC, we got an earthquake and a
hurricane. Odds of that must be 1 in several million.
Sept. 11, 2011 – 10th Anniversary of “9/11”. Much commemoration going on in NYC
and DC. Of note last week on Sept. 9 went to meeting in White House EEOB 530 with
Released by Chairman Rand Paul
251Eric Goosby, Gayle Smith and David Lane, Jeff Crowley and Dana DeRuiter (White
House); Lois Quam (USAID), Ariel Pablos-Mendez (USAID), Tom Frieden on the
phone; Nils Daulaire and Howard Koh (DHHS) and others. Purpose of the meeting was
to plan a strategy that the WH and the POTUS should take in addressing and utilizing the
recent scientific advances associated with HIV prevention, particularly treatment as
prevention (HPTN-052) in turning around the HIV pandemic. In essence it was a
meeting to figure out how we can implement what I proposed in Rome at the IAS
meeting in July, 2011. Eric Goosby and Gayle Smith want me to directly brief the
POTUS on this. It remains to be seen whether this happens. Clearly, the activists want
more money to go to PEPFAR for treatment and prevention. However, there are major
budget constraints. The WH is afraid of demonstrations during the upcoming IAS
meeting in Washington in the summer of 2012 – right before the election. They have to
walk a fine line between promising more money, which will inflame the right and doing
nothing, which will inflame the left. It seems that they are calling me in to help them
with this. More later……
Sept. 13 -14, 2011 – Beautiful crisp sunny day in DC. Started 09/13/11 with breakfast at
the Four Seasons in Georgetown at 7:00 Am with Bill Gates. Also present from the Bill
and Melinda Gates Foundation (BMGF) was Stefano Bertozzi. The theme was that Bill
is reluctant to fund (with NIAID) the proposed South Africa (RSA) and Thailand vaccine
trial for licensure since he thinks that the companies are charging too much money for the
protein (env – made by Novartis). In addition, he does not think that the results will lead
to a marketable product. However, we need the private sector or else we will never get a
vaccine made for HIV. The quid pro quo for us is that if we go with a regulatory
(licensure) trial in RSA and Thailand, the companies (Sanofi-Pasteur and Novartis) will
work with us on a research trial of comparing several products in RSA, which is what we
really want. I convinced Bill that this was a necessary evil and that although it was an
imperfect situation, it is still the only deal around since the product – Pox Vector +
Protein boost was the one that gave the only positive result in a vaccine trial to this point
(RV144 – conducted in Thailand 2 years ago). In addition, there are some possible
correlates of immunity associated with RV144. We ended the breakfast with a mutual
commitment to work together on this. Also, Bill had some interesting a bit “off the
wall” ideas about making a universal virus vector into which you can insert genes of
important neutralizing antibodies for different microbes that can be an instantaneous
antibody factory for bioterror organisms as well as for HIV, merely by changing the
insert. Also, Bill does not believe in treatment as prevention from a practical or logistic
point of view.
Went on to participate in a 2 day meeting run by the George W. Bush Presidential
Center – “The Summit to Save Lives” held at the Mellon Auditorium on Constitution
Avenue, N.W. I was on the panel to discuss the leveraging of PEPFAR resources and
infrastructure to do screening and treatment of cervical cancer in Africa and Latin
America. I studied up on HVP and cervical cancer and we the “scientific expert” on the
panel that included Eric Goosby (PEPFAR), Grosbeck Parham (C0-Director of Cervical
Cancer Prevention program, Zambia), Dr. Beatrice Wiaffe Addai – president of Breast
Care International. Panel Chaired by Jennifer Griffin, National Security Correspondence,
Released by Chairman Rand Paul
253together for HRC on the same subject that I spoke on in Rome – “The Science has now
shown that we can end the AIDS pandemic – we need to implement” Only difference is
that she will say that we can do it by increasing efficiencies PLUS having other partners
(donors and host countries) put in a greater share. I said that we should put in more
resources. The speech spins off the document mentioned above that we were asked to
put together following the Sept. 9 meeting (see above). The main issue is that we will
raise our goal of 4 million on treatment through PEPFAR by 2013 to 6 million by 2013.
With much input from me and CDC, Eric Goosby put together a nice document
explaining the importance of increasing this goal and having certain host countries such
as South Africa and Rwanda assume more of the cost of treatment so that we can
concentrate on countries with less resources such as DRC, Cameroon, Malawi,
Zimbabwe. Also, we can use more bulk purchases etc.
TODAY – (10/13/11) we had an important meeting in the Situation Room of the White
House from 4:00 to 5:30 PM. Gayle Smith instigated the meeting. It was a Deputies
Meeting chaired by Denis McDonough (Deputy National Security Advisor – Deputy to
Thomas Donilon). He was very good and sympathetic to our goal. Also there were:
Cheryl Mills, Eric Goosby, Tom Frieden, Steve Kosiak from OMB, Ariel Pablos-Mendez
Nancy-Ann deParle, Dana DeRuiter from NSS, Samantha Power (NSS), Charles Hohman
(OGAC). They called upon me to explain the scientific basis for our pushing to do more
to turn around the trajectory of the Pandemic. I explained the details of HPTN-052.
Great meeting – this may lead to an acceleration of our efforts. Also, Denis McDonough
asked us to put together a “Blue Sky” proposal that would ask for more resources in
addition to the increased efficiencies that we are already planning. We may not get more
money, but we can probably show the leadership to inspire others to invest more, i.e.
other rich countries. More later…….
Oct. 17-19, 2011 Eric and I among others worked on a paper that gave 2 options:
Scenario 1 – increase efficiencies and have host countries take more responsibility and
thus shift PEPFAR money to treatment as prevention. This ill raise the bar for goals to 6
million people on PEPFAR-paid Tx by 2013 and 8 million by 2015. Scenario 2 – get
$2.5 billion more money from 2013-2015 and raise goal to 8 million on treatment by
2013 and 10 million by 2015. Mathematically modeled (done by CDC), this would “tip”
the curve (of incidence) of the pandemic more sharply downward and would also have
many secondary benefits of saving lives and hospitalization. Denis McDonough now
refers to this as the “Fauci curve”.
Oct. 20, 2011 – Met again in WH Situation Room with Denis McDonough chairing and
the same people there with Tom Frieden by videoconference. Continued discussion
about “Blue Sky”. I again vigorously defended the concept of our golden opportunity at
this point. Problem is that OMB feels that we will never get new money passed through
Congress and State might have to “eat” the $2.5 billion if we actually pursue Blue Sky.
I suggested getting group of CEOs involved (as per my upcoming WSJ – CEO Council
meeting that I will chair on Nov. 15). Denis thought that it was a great idea and will
bring it to the POTUS. Again, budget problems may stand in the way of a visionary
breakthrough of “tipping” the pandemic.
Released by Chairman Rand Paul
254Oct. 24, 2011 – Met again at the WH (EEOB 439) with the usual cast of characters.
Gayle Smith chaired the meeting. Denis McDonough not there. Main issues again is the
reluctance of USAID (Ariel) to buy into the idea of expanding treatment as a way to “tip
the curve”. He suggested moving the money from the efficiencies of PEPFAR treatment
(see above) to non-treatment prevention modalities. Eric Goosby tried to explain that the
non-treatment prevention modalities (PMTCT, AMMC – adult medical male
circumcision) are already maxing out and any increasing or not are due to other issues
besides resources. I arguing strongly against Ariel and reminded people that this was a
POTUS initiative to increase Tx. Below is an e-mail that I sent to Gayle Smith after the
meeting clarifying my stance on this.
Gayle:
Thanks for running an important and sometimes contentious meeting today. You do it
masterfully. Please read my comments below and then you can either accept them or
throw them out if you wish and I will still be your friend. Here goes… Eric, Ariel,
and I, and hopefully Tom Frieden will get together by phone tomorrow to try and hash
out and hopefully resolve the issues that were brought up today regarding standard
prevention versus treatment as prevention. It appears that Ariel and USAID feel that in
an arena of a flat budget, the money saved by efficiencies in treatment should be turned
over to standard prevention modalities as opposed to expanding the number of people on
treatment (which is also prevention). As Eric will explain to Ariel tomorrow on our
phone call, the model that has been developed takes all of these issues into account and
the standard prevention modalities such as adult male circumcision and PMTCT to which
Ariel is referring can be maximized in a number of ways without significant increases in
resources, whereas putting more people on treatment clearly requires more money. You
can treat the same number of people with less money by efficiencies, but the only way to
get more people on treatment with a flat budget is to use the savings from
efficiencies. As we have been discussing, this will have the effect of preventing more
infections at the same time as saving the lives of the infected people who would now be
receiving treatment. This also results in other economic and social benefits. Although
you are trying to be fair to all points of view, in my humble opinion, if we go to the
Principals giving them a choice of the two approaches, we will confuse them. I believe
that they need to look at a single proposal that we have already agreed upon in our
discussions and decide if they are comfortable with it. Another point that seems to have
gotten lost by some in today’s discussion in the fact that, as I mentioned at the end, we
are talking about a potential game changing initiative by the POTUS that could be a
legacy. We are not talking about competition for limited money that might go to other
areas. Another issue is that the activist community would support the POTUS in an
initiative with no new money, but that includes a plan to increase the numbers of people
on treatment by the mechanisms that we had discussed with you and Denis. If he comes
out with a plan to divert savings from treatment efficiencies to non-treatment programs,
the constituencies will be infuriated. Sorry for taking your time with this e-mail. I just
felt that I needed to express my thoughts to you. Talk to you soon.
Best regards,
Tony
Released by Chairman Rand Paul
255Oct. 25, 2011 – Raj Shah (Administrator of USAID) called me at 1:30 PM to get a better
feel of my position on treatment as prevention. I thought that he would have a problem
with it, but he was really asking if it was better to target people with very early infection
since they are most likely to spread infection. I explained to him that although this was
the case, they represent a relatively small fraction of infected people and they are very
difficult to identify at this early stage.
I found out later in the day from Cheryl Mills (Chief-of –Staff to Hillary Clinton) that
Bill Gates had told Hillary that treatment as prevention was a waste of money and would
not work. Hillery (HRC) heard from Eric that Bill Gates is probably the only person in
the world who felt this way and that is exactly what I told Cheryl (see my breakfast with
Bill Gates above). It seems that HRC is to meet with Raj today to get his opinion and so
that is why Raj called me. Also, HRC will come to NIH on my suggestion to give
speech on this subject on Nov. 8. I helped drafting her speech.
Oct. 26, 2011 – Conference call with Eric, Ariel, me, Charles Holman and various people
from USAID, PEPFAR, and CDC (Tom Frieden) trying to hash out the difference
between Eric/me/Tom and USAID. It appears (maybe) that we have convinced Ariel
that our model is valid. More to come.
Oct. 31, 2011 – Another WH (EEOB 430A) meeting regarding above topic. Chaired by
Gayle Smith. Also there was Amy Batson (USAID), Lois Quam, and Tom Frieden by
phone. Cold crisp day in DC. Fall is here! Again the tension between USAID goals
and PEPFAR goals become clear. USAID is trying to enhance their own agenda, which
in my opinion has failed with their spending millions on prevention messages that do not
work. They are trying to derail the PEPFAR “scale up by efficiencies” initiative. Ariel
is turning out to either be naïve or nefarious. I always heard that he was a good guy, but
he and USAID team keep insisting that the efficiency money should go either to a
broader GHI or to enhancing the non-treatment prevention agenda (PMTCT, AMMC,
condoms, etc.). The PEPFAR/Fauci/CDC agenda is to use the efficiencies to scale up
Tx from 4.2 million by 2013 to 6+ million by 2013. This should reach 8 million by 2015
without any additional funds. If you go to “blue Sky” of +$2.5 billion from 2013 to
2015, you will go from 8 million in 2013 to 10 million in 2015. The PEPFAR model
also assumes and enacts a maxing out of the non-treatment prevention modalities.
USAID disagrees and want to use efficiency money to favor non-treatment as Prevention.
This is what Ariel is saying. After meeting with Eric Goosby, Ariel seems more
convinced that the PEPFAR model may be OK. However, what does Raj Shah
think????
Nov. 1, 2011 – Dinner with Rick Klausner at Matisse Restaurant on Wisconsin Avenue
and Fessenden. Discuss the Qatar initiative, see above and below. But, conversation
turned to Raj Shah and the PEPFAR/USAID story. Bottom line is that Raj has been
talking with Rick and it appears from Rick and my prior conversation with Raj that Raj is
not against treatment as prevention (TAP); however, he does not like the model and want
to do it differently. (More on Qatar later – stick with USAID/PEPFAR for now)
Released by Chairman Rand Paul
256Nov. 2, 2011 – 7:30 AM Get call from Rick Klausner who is having breakfast with Raj
Shah and Rick wants to set up teleconference with the 3 of us at 11:00 AM to discuss the
above issues. On the call Raj dances around a bit, but what he really wants is a big
initiative using PEPFAR money. He does not say so explicitly, but that is really what he
wants. He does not want the efficiency money to pay for 6 million of TAP by 2013; he
want 5.5 million for TAP and the rest for a full-court-press initiative to see in a selected 3
countries if maximizing both non-TAP and TAP prevention will actually end the
pandemic. I explain that there is not enough money to do this, and besides, the
expectation is to TAP, not do a study to prove that it could be done. He agrees with me
that we should do both within the constraints of budget. He is sure that the POTUS will
like this initiative since it is a scientifically-based approach (give me a break!!!). The
big elephant in the room is that USAID has been wasting $100s of millions on prevention
approaches (like behavior change) that do not work. They should use this $ to do their
proof of concept full-court-press approach, not try to siphon off PEPFAR money (I did
not say that, but this clearly was the elephant). Raj wants the have Eric, himself and I
put together another proposal to this effect.
After the call Rick e-mailed me and asked for a follow-up call. On that call Rick
explained that what Raj really wants is to spend all of the efficiency money on the 3
country demonstration project and that this would be the POTUS initiative. They (Rick
and Raj) just do not believe that PEPFAR/CDC model. Also, (amazingly), Raj admits to
Rick that the USAID has been wasting $100s of millions, but he is not up to taking on the
USAID bureaucracy. Rick is disappointed in him and thinks that he is being weak and
has told him so. However, rick is in favor of the concept since he has issues with
PEPFAR.
Based on this, I arranged a teleconference with Tom Frieden (at Atlanta airport), Eric,
Charles Holmes, and some PEPFAR people and CDC people to discuss all of this. Tom
Frieden was furious at USAID. He says that they have been wasting $ for years and now
they question what CDC proposes, when CDC has been saying for years that they should
have been scaling up AMMC and PMTCT instead of wasting money on behavior.
Clearly, Raj is a young, brilliant guy who is extremely ambitious (that is OK), but he
wants control of PEPFAR resources. Frieden is dead against this PEPFAR is obviously
against this. So am I. The original question was to use efficiencies to scale up TAP, not
to try something that USAID should have been doing all along with their own $. The
idea of nailing down whether we can end the pandemic with a full-court press (FCP) is a
good one, but there are no resources available. I propose that we do both the PEPFAR
plan and the FCP, the latter with $ that we get from additional sources.
White House meeting scheduled for Nov. 9. Everyone wants me there, but HHS will
have to decide who the “Plus one” is with Sebelius. Of note, I am scheduled to go to
Seattle on Nov. 9 for a town hall meeting and a seminar sponsored by Lee Hood and the
Institute for Systems Biology.
Bill Gates is trying to undermine the initiative on upscaling TAP. See e-mail below
from MSF to me sent on 11/02/11:
Dr. Fauci,
Released by Chairman Rand Paul
257Congratulations on getting NIH-supported HIV research the airing it
deserves at the highest levels of government. We are all looking
forward to Secretary Clinton's speech at the NIH next week.
We are trying to use the USG momentum to leverage new commitments from
the UK for World AIDS Day. So far DfID and other government actors are
interested in a "step up" initiative that we have also been pitching to
USG, South Africa, and Germany to pay for implementation of accelerated
treatment.
Today we had a bit of a minor set back: the Secretary for Development
Andrew Mitchell just heard from Bill Gates at a Tory event "Friends of
International Development" that HPTN 052 will not yield great effects
and the role of ART in limiting incidence is more limited than what is
being portrayed. It was unfortunate.
It would help greatly if the policy makers in government could hear the
science themselves. If the All-Party Parliamentary Group on AIDS
invited you to give a briefing, and we arranged for high-level
meetings, could you attend? Would an invitation by civil society and
MSF suffice? And, hardest question of all-- do you have any free days
where you could be in London in November?
Thank you,
Sharonann
--
Sharonann Lynch
HIV/AIDS Policy Advisor
Access to Essential Medicines Campaign
Médecins Sans Frontières (MSF)
Also see below e-mail from Nov. 3 from Michael Iskowitz describing what
the community actually is hearing about. It is amazing how things
leak sinceI have told no one what I am doing regarding USAID, PEPFAR
and the WH.
Finally, tonight (11/02/11) went to Book Signing party at Hay-Adams
Hotel for Chris Matthews on his new book “Jack Kennedy – Elusive Hero”.
Another example of the A group of Washington. It is clear that at age
70, being on the public/political/media scene for >30 years, I am
extremely well-known and even friends with so many public figures, who
merely on the basis of my being on TV/Radio/newspapers, etc. and the
fact that we run into each other at so many of these functions have
gotten to know me well. Just a sampling of people at event: Andrea
Mitchell; Alan Greenspan; Sens. Chris Dodd, John Kerry; Rep. Ed Markey,
Jim Moran; Howard Feinman; Murrey Jacobson; Luke Russert; Gloria
Borger; Joe Scarborough; etc. Had animated conversation with my
friend Ed Markey regarding the disgraceful conduct of the Banking
Industry and Wall Street. The “Occupy Wall Street” movement is
gaining momentum. The Republican scramble for the nomination is hot
and heavy
Released by Chairman Rand Paul
258Nov. 3, 2011 – Incredible day. Theme is my trying to hold together the
evolving proposal to scale up combination prevention with treatment as
prevention (TAP) being a major component of the scale-up as described
above. Tension is USAID and Raj want to spend most of the efficiency
money on concentrating and ending the epidemic in 3 chosen countries as
opposed to going with the PEPFAR/CDC/FAUCI plan of scaling up
combination prevention across the board and doing a demonstration full
court press (FCP)in selected pockets of the countries that we have
selected: Botswana for CDC; Zambia and South Africa for NIH; Tanzania
for USAID. Spent all day on calls individually with Tom Frieden, Eric
Goosby, Mark Dybul, Raj Shah (in the evening). Raj call was at the
suggestion of Rick Klausner who says that I am the only person who can
broker a deal between PEPFAR and USAID. We need USAID to support our
proposal at the WH meeting next week (Nov. 8 – the evening of
Secretary’s Clinton’s speech at NIH. I have cancelled Seattle to ne
at the WH meeting. WH house wants me and Frieden to represent HHS,
i.e. “plus 2”. Mark Dybul agrees somewhat with the need to have a
bold announcement as per Raj, but we all know that there is no new
money. Rick also feels that way. However, what neither of them
fully appreciate is that the “demonstration project” described above is
in reality a FCP in a selected group within countries. I had
important call with Raj. I leveled with him and said that although he
is proposing putting all of the PEPFAR efficiencies towards a FCP in 3
countries and scrapping the PEPFAR Plan, he should look to “clean his
own house” and create efficiencies within USAID and use that money to
scale up the 3 country approach and make it more of a FCP, i.e. I am
proposing a “hybrid” of the PEPFAR plan and the USAID plan since we all
need each other and we need to provide the POTUS with a proposal that
is scientifically sound, bold, yet not unrealistic, and that does not
require significant new money. Of note, Hillary Clinton will propose
$60 million of her money to beef up that “demonstration project” I
called for a meeting tomorrow to see if Raj, Eric, Tom and I could
figure out a compromise with me as the referee.
Also see below e-mail from Nov. 3 from Michael Iskowitz describing what
the community actually is hearing about. It is amazing how things
leak since I have told no one what I am doing regarding USAID, PEPFAR
and the WH.
tony dearest.
i just wanted to thank you for helping to create and drive another landmark moment in AIDS
history.
i continue to do consulting with eric -- who remains forever grateful for your friendship and
extraordinary leadership.
i am honored to have have many decades now of watching you work your magic -- forever urging
that if we remain steadfast and
follow the science, together we will win.
bless you for -- behind the scenes and in front of the cameras -- shaping another historic
moment.
know that i talk with eric frequently and if there is anything i can for you directly -- please know i
always stand ready.
thank you for being you and for all you do for the world,
if i am not at the NIH on tuesday -- i am certainly there in spirit!
much love,
michael
Released by Chairman Rand Paul
259Nov. 4, 2011 – I cancelled most of my AM calendar to attend meeting at
8:00 AM in Eric’s OGAC (Office of Global AIDS Coordinator) office at
2100 Pennsylvania Ave, N.W. (suite 200). At meeting was the 4 of us.
After about 90 minutes I got everyone to accept the “Fauci hybrid
plan”. Raj agreed (as I suggested last evening) that he come up with
about a few hundred million in efficiencies from USAID. Eric will try
to find more efficiencies from the PEPFAR “Pipeline”, all to beef up
the demonstration project and perhaps include another country such as
Nigeria. However, we will all need to see if our respective
demonstration projects could effectively absorb an additional few
hundred million $. We will work on this over the weekend. More to
come.
Also today met with Dr. Abdelali Haoudi, VP for Research of the Qatar
Foundation at the recommendation of Rick Klausner with whom I had
dinner on Nov. 1. Great meeting with Abdelali. Introduced him to JJ
McGowan, Kathy Zoon and Marv Kalt to help him with using the NIAID
model to get his Qatar intramural and extramural program set up. I
think that we could turn out to be friends.
Nov. 5-6, 2011 – Continued strain between USAID (Raj) and PEPFAR (Eric
and Charles) in that Raj just does not want to give in about pushing
for “doing things differently”. Nov. 5-6 is the weekend and
Department of State (Lorrie McHugh – communications) as well as Cheryl
Mills are lining up people (activists, etc.) to write blogs in
anticipation of Sec. Clinton’s Speech at NIH. Her speech (which I have
been deeply involved in writing follows the PEPFAR model, not the USAID
model. They have asked me to do an editorial for the NY Times giving
the scientific basis HRC’s speech. I worked all weekend and got a
great piece which I have circulated to Cheryl Mills, Burklow (NIH),
HHS, etc.
Nov. 7, 2011 - Full court press in preparing for Clinton visit and
speech. Again, I get call from Raj Shah wanting me to support his
“doing things differently”. I believe that he really does not fully
understand what PEPFAR is trying to do. He wants to scale up heavily
in high impact countries and not go for just scaling up prevention and
TAP. We are too far down the pike to change now even if we decided to
change. Hillary’s speech is tomorrow as is the White House Principal’s
meeting in the Situation Room. Ariel Ramos seems more convinced that
the PEPFAR model will work now that he has examined the models more
closely; however, Raj is still skeptical.
Nov. 8, 2011 - Beautiful, crisp, sunny Fall day! Fabulous event
with Clinton visit. Francis and I greeted her at the South entrance
of the NIH Clinical Center. Also waiting in background was Harold
Varmus and Nora Volkow. Warm and engaging conversation with HRC. I
showed her a picture of her and me at the Clinical Center during her
first visit in Feb., 1994. I welcomed all of the dignitaries to the
Masur Auditorium, said some warm words (see files) about the
relationship between HRC and me and then introduced Francis Collins who
introduced her. She gave a great delivery of the speech that I helped
write. Overwhelmingly positive response from audience and press and
bloggers immediately after. I sent in my Op-Ed to the NY Times (see
Released by Chairman Rand Paul
260files) and then went to White House for Principals Meeting in Situation
Room at 3:45 PM. Present were: Hillary Clinton, Jack Lew (OMB), Denis
McDonough (NSS), Chaired by Tom Donoline, Samantha Powers, Tom Frieden,
Raj Shah, Eric Goosby, Gayle Smith, Ariel Pablos-Mendez, etc. We
agreed upon Option #2, which is greater efficiencies to provide more $
and scale-up of non-Tx prevention as well as increasing the PEPFAR
target for prevention to 6 million by 2013 and 8 million by 2015. I
stressed to Tom Donoline that the POTUS should strongly call upon more
involvement by other donors, particularly China. He agreed. Of
note, Susan Rice teleconferenced in from NYC and she voted strongly for
Option $3 (Blue Sky), which would require an additional $2.5 Billion.
This is a good sound bite, but Jack Lew pointed out that given the
budget situation, the POTUS would have to back off on commitments that
he has already made to other programs in order to do this. Hillary
pointed out that this was not tenable. She also pointed out that we
needed to address the ADAP waiting lists.
Amazing situation. After returning from the White House, I heard from
Courtney Billet and Greg that HHS contacted us and said that although
they had no problem with the Op-Ed (see above) and actually cleared us
to send it to NY Times, the “White House” told HHS to have recall the
Op-Ed since it is “off message”. Still not sure what they mean since
State, HHS and everyone else approved it. Could be because I called
for more resources as well as more “efficiencies”
Another amazing situation – At around 7:00 PM, Raj Shah calls me up and
asks me to call a meeting with him, Eric and me to see if we could
modify the proposal that was agreed upon at Principal’s Meeting!!!.. He
still insists that the POTUS needs to come out with something
“different” and suggests using “pipeline” money from PEPFAR/USAID. He
wanted me to broker the meeting. I contacted Eric and bless his
heart, he is willing to meet. Meeting scheduled for 8:30 AM in Eric’s
office tomorrow.
Nov. 9, 2001 – Still no information on why the WH ordered me to recall
my Op-Ed. Have e-mailed Gayle Smith (NSS). I will explain situation
to her tomorrow and see if she has any insight.
Meeting did not occur at 8:30 AM because of scheduling issues. Will
try to do a call tomorrow
Nov.10, 2011 – Got some insight from Gayle, but am afraid she is not
telling me everything. She claims that she heard discussion about my
Op-Ed at the WH, but not by WHCOMS. Issue was whether it was a good
idea to put it out right after HRC’s speech since it already got great
PR and so why waste a Fauci Op-ED. Perhaps better to wait until the
POTUS does World AIDS Day. This could be true, but who knows? Gayle
did say that the OMB people might have been concerned by the couple of
words that said we need significant increases in resources, including
from other donor countries. This implies needing more USG resources,
which would obviously bother OMB. However, I could easily have
changed this to say we need significant new resources FROM other donor
countries. In any event, Gayle assured me that the Op-Ed was not “off
message” in the substance of its content. We will hold onto it for
now. Having said this, here is another example of the ridiculous need
to control the “message” on the part of this White House.
Released by Chairman Rand Paul
261Back to the Raj Shah intrigue. On Raj’s suggestion, Yesterday’s
scheduled meeting now a phone call among me, Eric, Raj, Tom Frieden.
Raj wanted to again bring up the possibility of doing something ”big”
since he feels that the POTUS will not have another opportunity. After
much discussion we explained to Raj again that “Blue Sky”, i.e. $2.5
billion will never get by OMB or the Congress and even so, the best way
forward according to the models is not to just pick out a few countries
and full-court-press. Raj goes along and we think it is over.
Apparently, immediately after the call, Raj calls Rick Klausner asking
him to convince me to not give in and adopt his plan. Rick calls me on
my way to The Inn at Little Washington for my delayed 70th birthday
present from Denise from last December. We are in the limo (rented by
Denise) and Rick tries to convince me to re-convene the group. He
says that Raj feels that I am the only one who could do this. Raj just
does not want to give up. However, out of want to go the extra mile,
I will call up Eric and Tom.
Nov. 11, 2011 – I call Eric and Tom and explain situation with Raj. I
convince them to give it one more try. Both are extremely skeptical,
impatient and wary of Raj. However, I indicate that we must ask Raj to
be very specific in what he wants to do and how he wants to do it and
where are we going to get the money. Raj has always been very vague
about all of these issues. He just keeps saying that what Eric is
proposing is old stuff and incremental and that he wants to suggest to
the POTUS something big and transforming. I will write an e-mail and
detail the conditions of another teleconference and/or meeting.
Nov. 15, 2011 – At the invitation of Alan Murray (Senior Editor of Wall
Street Journal) I spoke at the Wall Street Journal-sponsored CEO
Council event at The Four Seasons in Georgetown. My purpose was to
convince the CEOs to get involved in supporting financially and
otherwise the Global AIDS Pandemic activities. They were OK, but
somewhat clueless about the importance of global AIDS. In retrospect,
billionaire philanthropists would be a better audience.
That evening went to a reception at Bill Heseltine’s house for
Geena Davis. She remembered our prior discussions during her visit to
NIH. She is lovely – very tall, but lovely.
Nov. 19, 2011 – Gave Keynote Address at the Caribbean AIDS Conference
in The Bahamas. The Atlantis Hotel is surrealistic.
Nov. 21 – 30, 2011 – Spent hours on the phone trying to address the
ADAP waiting list since we (HHS/PEPFAR) felt that if the POTUS
announces a scale-up of treatment for PEPFAR, then the logical question
is what are we doing about the ADAP waiting list? Tom Frieden
suggested that we engage the drug companies. Since I know Jim Rooney
from Gilead, I made the initial contact which led to many phone calls
involving Jim and people from Gilead; people from HHS – me, Tom
Frieden, Mat Wakefield (HRSA), Sally Howard (chief-of-staff to
Sebelius), Dora Hughes as well as people from NASTAD and Welvista.
Important issues is the Gilead agreed to greatly lower their prices for
people on ADAP waiting list
Dec.1, 2011 – World AIDS Day (WAD). A very special day. The White
House has decided that the venue for the POTUS statement on WAD would
be George Washington University in a program sponsored by One and RED,
Released by Chairman Rand Paul
262Bono’s organizations. Sanjay Gupta was the MC. We had Presidents
Bush and Clinton by live video conference and President Obama delivered
the speech that Eric Goosby, Tom Frieden and I and others wrote for
him. As expected, he went with Option #2 (see above – Nov. 8, 2011).
In addition, he included an additional $15 million (for Clinics) + $35
million (for States) = $50 million for ADAP total. Again, Tom Frieden
and HHS people (see above) have been working on the “domestic option”
for the past couple of weeks to offset criticism that we were paying
attention to global, but not domestic AIDS.
Following the POTUS speech, there was a panel moderated by Sanjay
consisting of Bono, Alecia Keys, Kay Warren, Rep. Barbara Lee, Sen.
Marco Rubio and a few others. I was told a few days prior that Sanjay
would turn to me with a question sometime during the program. Right
after Pres. Clinton’s live video speech, Sanjay said that you cannot
have a discussion about HIV/AIDS without including Tony Fauci (who is
in the audience) and his perspective on the science and he turned to me
to speak. I spoke for a few minutes about the fact that the
scientific data were overwhelming (circumcision; treatment as
prevention, etc.) and the task now was to implement the science. The
statement was similar to what I had said at the IAS meeting in Rome in
July. Right after my comment, Bono said that he must tell a funny
story and he proceeded to describe the night when he came to my house
for dinner to discuss what we could do to push the global AIDS agenda.
He was cute. He said that his friend Bobby Schriver told him that the
only person that could break the logjam on Global AIDS programs was
Tony Fauci. He finished by calling me a “proper hero”. A YouTube
record of this statement by Bono is available for Dec. 1. Also, I had
a chance to say a few words to Pres. Obama as he was “working the line”
following his speech. He congratulated me for the great work that we
were doing and that he has been hearing about. All in all, a really
good day!!
Of note, Gregg Gonsalves wrote a scathing letter to Raj Shah (that went
viral on the internet) scolding him for obstructing the treatment as
prevention initiative (see above discussions re: Raj). Unclear to me
how Gregg found out about all of this.
Dec. 2,, 2011 – Finishing off WAD activities, went to Harvard on a
beautiful crisp clear December day and participated in the AIDS@30
International Symposium. I gave the keynote “Perspective” on vaccines
and participated in a panel Chaired by Bruce Walker and consisting of
Bob Gallo, Nelson Michael, Jerry Sadoff, and Julie McElrath. Flew up
to Boston with Eric Goosby and flew back to DC with Nelson Michael.
All good.
Dec. 2 thru 21, 2011 - Significant issues regarding dual use research.
Check press from Dec. 20-21, 2011. Briefly, NIAID funded 2 studies –
subcontract via CEIRS (Centers of Excellence for Influenza Research and
Surveillance) to Erasmus University in Netherlands (Ron Fouchier) and
grant to Yoshi Kawaoka at Wisconsin to study feasibility and mechanism
of getting the highly lethal (60%), but poorly transmissible H5N1 (bird
flu) that has been smothering in SE Asia since 1997 to become
transmissible and maintain lethality in a mammal model (ferret).
Rationale for the study was to determine – Can it happen (in mammals)
since many people reasonably assume that it cannot since it has not
done this in nature despite being around in chickens and rarely in
humans since 1994? Also, if it does become transmissible by point
Released by Chairman Rand Paul
263mutations followed by passaging in ferrets (the experimental
methodology), then what is the signature of it so that health officials
in the field could do better surveillance and also design better
diagnostics, therapies and possibly vaccine. Both papers (with slight
differences found that relatively few mutations (~5) followed by serial
passage in ferrets led to virus that had better transmissibility and
kept virulence. Kawaoka paper showed increased transmissibility but not
maintenance of virulence, while Fouchier paper showed both. Papers
submitted to Nature (Kawaoka) and Science (Fouchier). Program staff
(NIAID), Fouchier and editors asked (because of possibility of dual
use) the NSABB to examine the results and advise if it was OK to
publish. Kawaoka was asked by NIAID to do the same. To everyone’s
surprise, the NSABB recommended that the papers be published with the
conclusions, but with redaction of the key results, mutations and
methodologies. I believe that this was group think and “cover your
ass”. Decision was to do this and provide a link in the paper whereby
people (health officials, legitimate scientists, PHARMA, etc) who have
a need to know can have access to the data. This was a precedent
setting recommendation that was virtually impossible to ignore even
though I disagreed with it since the complexity of influenza
adaptability is extremely complex and it is unlikely that terrorists
could replicate this work largely because it is unlikely that if that
this model just simply predicts that it will maintain these
characteristics if taken from ferret to human. Furthermore and more
importantly, since the data had already been presented (by Fouchier) at
an international meeting in Malta and the papers were reviewed by
several reviewers and known by many, the data are already “out their”
and would