Document text
From: "Fauci, Anthony (NIH/NIAID) [E]"
</O=NIH/OU=NIHEXCHANGE/CN=NIAID/CN=AFAUCI>
To:"Fauci, Anthony (NIH/NIAID) [E]" <[email protected]>
Subject: history
Date: Sat, 11 Jul 2015 17:50:16 -0400
Importance: Normal
Attachments: historical_record_of_A.S._Fauci.docx
Released by Chairman Rand Paul
1 HISTORICAL RECORD OF HIV/AIDS
Anthony S. Fauci, M.D.
Director
National Institute of Allergy and Infectious Diseases
National Institutes of Health
This written record will start today (April 11, 2001) and will state some events
retrospectively. I have other records including 2 dictated tapes that should be noted. The event
that precipitated this written record, which I hope that I can regularly contribute to is the tidal
wave of activity concerning the possibility of treating HIV-infected individuals in developing
nations and in sub-Saharan Africa specifically.
Towards to end of the Clinton Administration, Leon Fuerth who was the National
Security Advisor to VP Al Gore had set into motion a Task Force on which I was included (see
other records) to develop a plan to “treat infected Africans and provide some infrastructure,
prevention, etc. The group involved USAID, CDC, NIH, White House, State Department and
others. After the election, obviously, this dissolved. However, with the new George W. Bush
administration, Secr. of State Colin Powell and Secr of DHHS, Tommy G. Thompson became
very interested. Starting from the end of March I began intensive briefings of Secretary.
Thompson and members of his staff, particularly Terrell Halaska (Deputy Chief of Staff, DHHS)
and William Steiger (Special Assistant for International Affairs at DHHS) trying to convince
them of the need for USA involvement in the rapidly growing international interest in developing
a forum for treating Africans with HIV. Also, I had several interactions with Anne Phelps of the
Domestic Policy Council at the White House. During all of this, I had turned down the offer to
be Director of NIH. I was asked by Ed. Moy (Director of Presidential Personnel at the White
House) and by Secr. Thompson. My reason was that I wanted to concentrate of Global Health
problems, particularly HIV/AIDS in developing nations such as sub-Saharan Africa. They
regretted my not taking the job, but were enthusiastic and quite flattering about my work on
AIDS and encouraged to take a leadership role in pushing the AIDS (as well as TB and malaria)
global agenda. This was especially true of Secr. Thompson with whom I was rapidly developing
an excellent relationship.
March 2, 2001 – meet with Anne Phelps at White House to discuss global AIDS and other
issues.
April 3, 2001 – Extensive briefing of Secr. Thompson’s staff (Halaska, Steiger, Ann Agnew)
regarding International AIDS. Secretary Thompson dropped by and spent most of the hour.
After the meeting he called me into his office to speak in private (Bob Woods (Chief of Staff)
and Brett Davis (Special Assistant to the Secretary) were there. Thompson said he wanted me to
be his point man on AIDS and to spearhead our international endeavors. Stated that he and Colin
Powell would lead a Task Force on International AIDS and he wanted me to be the “go-to
person”.
April 4, 2001 - I was asked to prepare talking points on AIDS for Secretary. Thompson for his
upcoming plane trip with Pres, Bush to (?). I did so. Thompson’s staff was so impressed with
Released by Chairman Rand Paul
2the talking points that they mentioned that Thompson wanted me to accompany his staff to the
White House the next day to develop a white paper for Powel and Thompson to use in upcoming
meeting with the POTUS.
April 5, 2001 - Several hour meeting in the Situation Room of the White House chaired by Gary
Edson (Condoleeza Rice’s Deputy) of NSC. Meeting attended by….. Bill Steiger charged with
developing paper.
April 8 – 10, 2001 – I exchanged several drafts of white paper with Steiger and make significant
changes and input. It was clear that much of the paper included material from my talking points
for Thompson (see above).
April 11, 2001 – Attached below is the document and some comments.
---------------------- Forwarded by Millicent H. Schwenk/NSC/EOP on
04/11/2001 11:16 AM ---------------------------
Gary R. Edson
04/10/2001 09:00:45 PM
Record Type: Record
To: Millicent H. Schwenk/NSC/EOP@EOP
cc:
Subject:
Millie: I haven't reviewed this to see what;'s changed, but you should look
at it.
---------------------- Forwarded by Gary R. Edson/NSC/EOP on 04/10/2001
09:01 PM ---------------------------
(Embedded
image moved [email protected]
to file: 04/10/2001 07:05:59 PM
PIC07622.PCX)
Released by Chairman Rand Paul
3Record Type: Record
To: Gary R. Edson/NSC/EOP
cc: [email protected]
Subject:
my hhs dial-up e-mail is down tonight. i wanted to send you a slightly
modified version after receiving additional comments from dr. fauci. i am
sending in the body of the e-mail because i am not certain the attachment
will
go through. let me know if you have any questions or need me to do
anything
else. thanks, steiger
Draft
Privileged and Confidential
For Official Use Only
Infectious diseases, including HIV/AIDS, malaria, and tuberculosis, are
ravaging developing nations, causing 25 percent of all deaths worldwide and
eroding recent gains in economic growth, education, and life expectancy.
Tuberculosis accounted for 1.7 million deaths last year, while malaria
killed
more than one million, mostly children in Africa. At the same time, the
spread
of HIV/AIDS is triggering a crisis in international public health, the full
scope of which we are only beginning to recognize. The Joint United Nations
Programme on HIV/AIDS (UNAIDS) estimates that 36 million people are now
living
with HIV or AIDS, 70 percent of them in sub-Saharan Africa, where the
disease
is now the leading cause of death. Nearly 60 million people have become
infected with HIV since the beginning of the epidemic in the 1970's and
over
22 million of them have already died from AIDS.
The U.S. has been the leader in research and assistance to battle these
diseases, and the President?s recent proposed budget increase for the
National
Institutes of Health (NIH) reaffirms that commitment. NIH spent an
estimated
$90 million on international HIV/AIDS research in FY 2000, a number that is
expected to rise to $130 million by the end of FY 2001. The U.S. is the
Released by Chairman Rand Paul
4largest single donor to UNAIDS and the largest contributor to international
HIV/AIDS treatment and prevention programs, a total of more than $460
million
in FY2001. The Centers for Disease Control and Prevention (CDC) spent over
$100 million on HIV/AIDS prevention in FY 2001. The U.S. Government has
also
dramatically increased its investment in international malaria and
tuberculosis efforts to $110 million in FY 2001.
Our programs for taking care of our own population affected by HIV/AIDS and
tuberculosis are also world leaders. HHS is providing over $10 billion in
FY
2001 for HIV/AIDS-related assistance. This includes $795 million for
prevention services through the CDC and other agencies, $1.8 billion for
Ryan
White medical and related support services for individuals and families
with
HIV/AIDS, including the AIDS Drug Assistance Program; $2.2 billion for
NIH-funded HIV/AIDS research, including $280 million in vaccine research;
$4.3
billion for HIV/AIDS-related coverage for Medicare and Medicaid
beneficiaries.
Over the last several years the scope of the infectious disease crisis in
the
developing world has led the U.S and other industrialized nations to make
international public health an important item on their foreign policy
agendas.
In Okinawa in July of 2000, the U.S. and our G-8 partners committed to
promoting investments and partnership to prevent and control HIV/AIDS,
tuberculosis and malaria and to accelerate the development of new vaccines.
More recently, wider public attention has turned to the challenges posed by
these diseases as pharmaceutical manufacturers have announced price
reductions
in developing countries for their main anti-retroviral drugs. These price
cuts are a significant step forward and have sharpened debate on the
question
of how best to provide treatment to the populations most affected by the
HIV/AIDS epidemic, malaria, and tuberculosis.
As Senator Bill Frist (R-TN) has recently suggested, the U.S. has a moral
obligation to provide leadership in mobilizing additional resources for
international health. Stopping the spread of infectious diseases is also
in
our own enlightened self-interest, given the threats HIV/AIDS and other
maladies now pose to the political and economic stability of Africa and
other
important regions of the world. It is in our public health interest to
address tuberculosis as well, since 43 percent of U.S. TB cases are among
Released by Chairman Rand Paul
5foreign-born persons. We also believe the U.S. has a duty to ensure that
those resources go to efforts that are medically and scientifically sound
and
will contribute to the development of a sustainable health infrastructure
in
the most affected countries so that they can meet their challenges
themselves
over time.
Providing drugs at or below cost is only part of the solution. It is
estimated that approximately 50 percent of HIV-infected people in the U.S.
meet the HHS treatment guidelines for beginning antiretroviral therapy.
What
this percentage might be in developing nations is unclear. However,
perhaps
as important as providing antiretroviral drugs in some circumstances is
treating opportunistic infections and providing nutrition and clean water.
Yet even if enough drugs to treat every single infected person were sent,
free
of charge, to the African continent, an adequate surveillance
infrastructure
for testing for HIV infection and an adequate health care delivery system
for
administering the drugs do not exist in many countries. Furthermore, the
capability of monitoring patients to insure they are taking these complex
regimens of drugs properly and to determine the spectrum of toxicity and
the
effect of treatment on the spread of the disease There is no existing
surveillance capability to ensure that patients follow extremely
complicated
drug regimens accurately, or to monitor what effect the treatment has on
the
spread of the disease is sorely lacking in many places. We should begin to
help create the basic system to provide needed medications for
opportunistic
infections and symptomatic care, while also building the more complex
systems
needed to provide antiretrovirals and other medicines safely and
effectively
to avoid creating resistant strains, a lesson we have learned from efforts
to
control tuberculosis.
At the same time, we must continue to focus our efforts on prevention ? a
proven strategy that is cost-effective. Government accountability,
individual
behavior change and abstinence-based approaches (where they are culturally
appropriate) must be part of prevention efforts. We have found that
Released by Chairman Rand Paul
6working
with local organizations, such as missionary hospitals and clinics, is an
effective way to lessen the impact of the epidemic on individuals, families
and communities. We should also encourage countries to adopt
comprehensive,
evidence-based national strategies to ensure the resources we devote to
this
challenge are well-managed to produce the results we seek.
This is not, however, an issue that the U.S. Government can -- or should --
solve single handedly. We must reach out to a number of partners: our
allies,
the international community, pharmaceutical manufacturers, non-profits like
the Gates Foundation, and the faith-based community that has infrastructure
on
the ground in the developing world. A successful strategy to reduce the
impact of infectious disease requires close donor cooperation to achieve
maximum efficiency and avoid competition and duplication of efforts. The
Bush
Administration stands ready to contribute to a comprehensive plan to
improve
the public health delivery system in Africa and other parts of the world
where
HIV is rapidly expanding, an effort that should include prevention of new
infections, care for the sick, provision of drugs, and training of medical
professionals.
To this end, we appeal to the world to join us in establishing a new,
multi-lateral Global Fund to Fight Infectious Diseases, an international
public-private partnership to provide grants for prevention and health
infrastructure development focused on fighting HIV/AIDS, malaria, and
tuberculosis.
We believe the fund should operate under the following series of core
principles:
? Our goals are to prevent new HIV infections and treat those already
afflicted, to build the infrastructure for health care and disease control,
and to develop and train human resources.
? We seek to support a community-driven process that identifies the
needs of
affected areas and allows communities themselves to develop an appropriate,
comprehensive set of medical, social and support services.
? We must build on already established institutions and networks in
local
areas, including research relationships, to ensure we are creating human
and
physical capacity that is sustainable over the long run.
? We support an integrated approach focusing on prevention, delivery,
care and
Released by Chairman Rand Paul
7treatment. We also wish to include components for health infrastructure
improvement, surveillance of epidemics and care for orphans.
? We will outline and agree to fund a core menu of ?best practice?
programs,
according to certain quality standards and experience with evidence-based
models proven to work in developing countries.
? We will solicit letters of intent from governments and
non-governmental
organizations (NGOs), especially faith-based groups, that describe plans to
implement one of more of our core models in local areas.
? We will require demonstration of local leadership and adherence to
international standards of financial accountability and transparency. We
will
give preference to comprehensive plans that involve governments and civil
society working together.
? We will link our efforts in health to expanded programs in the areas
of
education and nutrition in an international parallel to the
Administration?s
campaign to ?Leave No Child Behind.?
? We are committed to a policy of promoting intellectual property
protection,
including for pharmaceutical patents, because of its critical role in the
rapid innovation, development, and commercialization of effective and safe
drug therapies and vaccines. Financial incentives are needed to develop
new
medications. No one benefits if research on such products is discouraged.
With more than 50 years of experience with health projects and a proven
institutional capacity to manage large financial transactions, the World
Bank
should serve as the fiscal agent for the Fund. As trustee, the Bank would
not
be involved in matters of policy, but would serve as the repository for
contributions from both governments and private donors and ensure the
prompt
disbursement of grants. A small Executive Secretariat housed at the Bank
and
jointly staffed by the Bank, UNAIDS and the World Health Organization would
undertake the day-to-day management of the trust fund, including soliciting
grant proposals.
A high-level Governing Council would provide the overall strategic
direction
for the fund. Donors that contribute at least $xx million and
representatives
of the developing world (serving in their own personal capacity and not as
the
Released by Chairman Rand Paul
8emissaries of any particular state) would form the membership of this
board.
The Council would fully control all fund decisions, including determining
programmatic allocations, operational rules and procedures, policies and
strategies, approving financial plans and work programs, and attracting
additional donations. In addition, the Council would make the final
determination of the list of ?best practice? models the fund would
underwrite
and the criteria necessary to win approval of letters of intent. The
president of the World Bank, the Director General of UNAIDS and the
Director
General of WHO would be ex officio, non-voting members of the Council.
Much like a university endowment, the fund would have a two-tiered
financial
structure. The "core fund" would comprise a pool of resources that could
be
support any activity falling within the work program and eligibility
criteria
approved by the Governing Council (except for limited restrictions by
donors).
At the same time, however, the fund would permit donors to earmark
contributions for use on their particular priorities, as long as they fell
within the overall purposes and priorities of the trust fund. Both ?core?
and
dedicated resources would be combined in each grant in a way transparent to
the recipient.
Composed of international scientific, medical, public health and
development
experts, a Scientific and Public Health Review Committee would perform a
rigorous technical peer review process to assess the grant applications.
Drawn from developing and developed countries and international
organizations,
with experience in the affected countries, such as UNAIDS and WHO, the
Committee will make final decisions about the feasibility and
sustainability
of proposed programs according to criteria for each ?best practice? model
prescribed by the Governing Council. The Committee will also operate under
broad guidelines that spell out the recommended ratio of expenditures on
prevention, treatment, and research the Council would prefer projects
follow.
The models we might support could cover primary prevention and education
programs up to more sophisticated, comprehensive efforts that could involve
basic care and treatment, controlled delivery of antiretroviral therapy,
medical training, and clinical trials. Applicants will determine which one
of
the approved packages would be most appropriate and useful for the local
Released by Chairman Rand Paul
9context. Some might ask for resources to upgrade or build health centers
to
deliver basic HIV/AIDS or tuberculosis care and prevention programs.
Others
might want help with such programs plus training for physicians, lab
workers,
nurses, community health volunteers, and pharmacists. Still others might
integrate both models with the provision of complex drug treatment. Every
funded model will also include localized monitoring to assure the efficacy
of
the grant and to help inform the selection of proposals in the future. We
will also emphasize technical assistance to those countries and
organizations
that are unable to satisfy our criteria in their letters of intent, so that
over time they might also be able to participate.
The Administration is committed to making the fight against the global
HIV/AIDS epidemic and other killers a priority, and we ask our friends and
partners to join with us in a single, worldwide effort.
____________________________________________________________________
Get free email and a permanent address at http://www.amexmail.com/?A=1
April 11, 2001 – Attached below is what is to be the final document:
Draft
Privileged and Confidential
For Official Use Only
Infectious diseases, including HIV/AIDS, malaria, and tuberculosis, are ravaging developing
nations, causing 25 percent of all deaths worldwide and eroding recent gains in economic
growth, education, and life expectancy. Tuberculosis accounted for 1.7 million deaths last year,
while malaria killed more than one million, mostly children in Africa. At the same time, the
spread of HIV/AIDS is triggering a crisis in international public health, the full scope of which
we are only beginning to recognize. The Joint United Nations Programme on HIV/AIDS
(UNAIDS) estimates that 36 million people are now living with HIV or AIDS, 70 percent of
them in sub-Saharan Africa, where the disease is now the leading cause of death. Nearly 60
million people have become infected with HIV since the beginning of the epidemic in the 1970's
and over 22 million of them have already died from AIDS.
The U.S. has been the leader in research and assistance to battle these diseases, and the
President’s recent proposed budget increase for the National Institutes of Health (NIH) reaffirms
Released by Chairman Rand Paul
10that commitment. NIH spent an estimated $90 million on international HIV/AIDS research in
FY 2000, a number that is expected to rise to $130 million by the end of FY 2001. The U.S. is
the largest single donor to UNAIDS and the largest contributor to international HIV/AIDS
treatment and prevention programs, a total of more than $460 million in FY2001. The Centers
for Disease Control and Prevention (CDC) spent over $100 million on HIV/AIDS prevention in
FY 2001. The U.S. Government has also dramatically increased its investment in international
malaria and tuberculosis efforts to $110 million in FY 2001.
Our programs for taking care of our own population affected by HIV/AIDS and tuberculosis are
also world leaders. HHS is providing over $10 billion in FY 2001 for HIV/AIDS-related
assistance. This includes $795 million for prevention services through the CDC and other
agencies, $1.8 billion for Ryan White medical and related support services for individuals and
families with HIV/AIDS, including the AIDS Drug Assistance Program; $2.2 billion for NIH-
funded HIV/AIDS research, including $280 million in vaccine research; $4.3 billion for
HIV/AIDS-related coverage for Medicare and Medicaid beneficiaries.
Over the last several years the scope of the infectious disease crisis in the developing world has
led the U.S and other industrialized nations to make international public health an important item
on their foreign policy agendas. In Okinawa in July of 2000, the U.S. and our G-8 partners
committed to promoting investments and partnership to prevent and control HIV/AIDS,
tuberculosis and malaria and to accelerate the development of new vaccines.
More recently, wider public attention has turned to the challenges posed by these diseases as
pharmaceutical manufacturers have recently announced price reductions in developing countries
for their main anti-retroviral drugs. These price cuts are a significant step forward and have
sharpened debate on the question of how best to provide treatment to the populations most
affected by the HIV/AIDS epidemic, malaria, and tuberculosis.
As Senator Bill Frist (R-TN) has recently suggested, the U.S. has a moral obligation to provide
leadership in mobilizing additional resources for international health. Stopping the spread of
infectious diseases is also in our own enlightened self-interest, given the threats HIV/AIDS and
other maladies now pose to the political and economic stability of Africa and other important
regions of the world. It is in our public health interest to address tuberculosis as well, since 43
percent of U.S. TB cases are among foreign-born persons. We also believe the U.S. has a duty to
ensure that those resources go to efforts that are medically and scientifically sound and will
contribute to the development of a sustainable health infrastructure in the most affected countries
so that they can meet their challenges themselves over time.
Released by Chairman Rand Paul
Providing drugs at or below cost is only part of the solution. Only a portion of the total HIV-
infected population will meet criteria for beginning antiretroviral therapy. Far more need
community support and basic care for opportunistic infections, such as tuberculosis, and for
prevention, care and treatment of sexually transmitted diseases. Yet even if enough drugs to
treat every single infected person were sent, free of charge, to the African continent, an adequate
infrastructure to deliver them does not exist. There is no existing surveillance capability to
ensure that patients follow extremely complicated drug regimens accurately, or to monitor what
effect the treatment has on the spread of the disease. We should begin to help create the basic
system to provide needed medications for opportunistic infections and symptomatic care, while
also building the more complex systems needed to provide antiretrovirals and other medicines
safely and effectively to avoid creating resistant strains, a lesson we have learned from efforts to
control tuberculosis.
At the same time, we must continue to focus our efforts on prevention – a proven strategy that is
cost-effective. Individual and government accountability, behavior change and abstinence-based
approaches that are culturally appropriate must be part of prevention efforts. We have found that
working with local organizations, such as missionary hospitals and clinics, is an effective way to
lessen the impact of the epidemic on individuals, families and communities. We should also
encourage countries to adopt comprehensive, evidence-based national strategies to ensure the
resources we devote to this challenge are well-managed to produce the results we seek.
This is not, however, an issue that the U.S. Government can -- or should -- solve single handedly.
We must reach out to a number of partners: our allies, the international community,
pharmaceutical manufacturers, non-profits like the Gates Foundation, and the faith-based
community that has infrastructure on the ground in the developing world. A successful strategy
to reduce the impact of infectious disease requires close donor cooperation to achieve maximum
efficiency and avoid competition and duplication of efforts. The Bush Administration stands
ready to contribute to a comprehensive plan to begin building a public health delivery system in
Africa and other parts of the world where HIV is rapidly expanding, an effort that should include
prevention of new infections, care for the sick, provision of drugs, and training of medical
professionals.
To this end, we appeal to the world to join us in establishing a new, multi-lateral Global Fund to
Fight Infectious Diseases, an international public-private partnership to provide grants for
prevention and health infrastructure development focused on fighting HIV/AIDS, malaria, and
tuberculosis.
We believe the fund should operate under the following series of core principles:
•Our goals are to prevent new infections and treat those already afflicted, to build the
infrastructure for health care and disease control, and to develop and train human resources.
•We seek to support a community-driven process that identifies the needs of affected areas
and allows communities themselves to develop an appropriate, comprehensive set of
medical, social and support services.
Released by Chairman Rand Paul
12•We must build on already established institutions and networks in local areas, including
research relationships, to ensure we are creating human and physical capacity that is
sustainable over the long run.
•We support an integrated approach focusing on prevention, delivery, care and treatment. We
also wish to include components for health infrastructure improvement, surveillance of
epidemics and care for orphans.
•Our intent is to start with a relatively limited number of projects, to research which
approaches work best and are adaptable to local conditions, before scaling up over the next
few years.
•We will outline and agree to fund a core menu of “best practice” programs, according to
certain quality standards and experience with evidence-based models proven to work in
developing countries.
•We will solicit letters of intent from governments and non-governmental organizations
(NGOs), especially faith-based groups, that describe plans to implement one of more of our
core models in local areas.
•We will require demonstration of local leadership and adherence to international standards of
financial accountability and transparency. We will give preference to comprehensive plans
that involve governments and civil society working together.
•We will link our efforts in health to expanded programs in the areas of education and
nutrition in an international parallel to the Administration’s campaign to “Leave No Child
Behind.”
•We are committed to a policy of promoting intellectual property protection, including for
pharmaceutical patents, because of its critical role in the rapid innovation, development, and
commercialization of effective and safe drug therapies and vaccines. Financial incentives are
needed to develop new medications. No one benefits if research on such products is
discouraged.
With more than 50 years of experience with health projects and a proven institutional capacity to
manage large financial transactions, the World Bank should serve as the fiscal agent for the
Fund. As trustee, the Bank would not be involved in matters of policy, but would serve as the
repository for contributions from both governments and private donors and ensure the prompt
disbursement of grants. A small Executive Secretariat housed at the Bank and jointly staffed by
the Bank, UNAIDS and the World Health Organization would undertake the day-to-day
management of the trust fund, including soliciting grant proposals.
A high-level Governing Council would provide the overall strategic direction for the fund.
Donors that contribute at least $xx million and representatives of the developing world (serving
in their own personal capacity and not as the emissaries of any particular state) would form the
membership of this board. The Council would fully control all fund decisions, including
Released by Chairman Rand Paul
13determining programmatic allocations, operational rules and procedures, policies and strategies,
approving financial plans and work programs, and attracting additional donations. In addition,
the Council would make the final determination of the list of “best practice” models the fund
would underwrite and the criteria necessary to win approval of letters of intent. The president of
the World Bank, the Director General of UNAIDS and the Director General of WHO would be
ex officio, non-voting members of the Council.
Much like a university endowment, the fund would have a two-tiered financial structure. The
"core fund" would comprise a pool of resources that could be support any activity falling within
the work program and eligibility criteria approved by the Governing Council (except for limited
restrictions by donors). At the same time, however, the fund would permit donors to earmark
contributions for use on their particular priorities, as long as they fell within the overall purposes
and priorities of the trust fund. Both “core” and dedicated resources would be combined in each
grant in a way transparent to the recipient.
Composed of international scientific, medical, public health and development experts, a
Scientific and Public Health Review Committee would perform a rigorous technical peer review
process to assess the grant applications. Drawn from developing and developed countries and
international organizations, with experience in the affected countries, such as UNAIDS and
WHO, the Committee will make final decisions about the feasibility and sustainability of
proposed programs according to criteria for each “best practice” model prescribed by the
Governing Council. The Committee will also operate under broad guidelines that spell out the
recommended ratio of expenditures on prevention, treatment, and research the Council would
prefer projects follow.
The models we might support could cover primary prevention and education programs up to
more sophisticated, comprehensive efforts that could involve basic care and treatment, controlled
delivery of antiretroviral therapy, medical training, and clinical trials. Applicants will determine
which one of the approved packages would be most appropriate and useful for the local context.
Some might ask for resources to upgrade or build health centers to deliver basic HIV/AIDS or
tuberculosis care and prevention programs. Others might want help with such programs plus
training for physicians, lab workers, nurses, community health volunteers, and pharmacists. Still
others might integrate both models with the provision of complex drug treatment. Every funded
model will also include localized monitoring to assure the efficacy of the grant and to help
inform the selection of proposals in the future. We will also emphasize technical assistance to
those countries and organizations that are unable to satisfy our criteria in their letters of intent, so
that over time they might also be able to participate.
We believe the nearly complete drive to eliminate polio offers us a model to develop a strategy
to control HIV/AIDS and the other major killer infectious diseases. The Administration is
committed to making the fight against the global HIV/AIDS epidemic and other killers a priority,
and we ask our friends and partners to join with us in a single, worldwide effort.
Bullets for above document are listed below:
Draft—For Official Use Only
Released by Chairman Rand Paul
14Global Fund to Fight Infectious Diseases
Bush Administration response to the crisis HIV/AIDS and other diseases have triggered in
international public health.
Multi-lateral, international public-private partnership to provide grants for prevention and
health infrastructure development focused on fighting HIV/AIDS, malaria, and tuberculosis.
Comprehensive plan to begin building a public health delivery system in Africa and
elsewhere, an effort that should include prevention of new infections, care for the sick,
provision of drugs, and training of medical professionals.
Cooperation by many partners: our G-8 allies, the international community, pharmaceutical
manufacturers, non-profits like the Gates Foundation, and the faith-based community that has
a presence on the ground in the developing world.
Goals
•Prevent new infections, treat those already afflicted, build infrastructure for health care and
disease control, and develop and train medical personnel.
•Identify the needs of affected areas and allow communities themselves to develop an
appropriate, comprehensive set of medical, social and support services.
•Build on already established institutions and networks in local areas, including research
relationships to ensure countries can sustain the fight on their own over time.
Approach
•Integrated approach focusing on prevention, delivery, care and treatment, along with
components for health infrastructure improvement, surveillance of epidemics and care for
orphans.
•Start with a relatively limited number of projects, to research which approaches work best
and are adaptable to local conditions, before scaling up over the next few years.
•Link our efforts in health to expanded programs in the areas of education and nutrition in an
international parallel to the Administration’s campaign to “Leave No Child Behind.”
•Work cooperatively with major pharmaceutical companies to ensure greater availability of
access to key drug treatments.
•Continue to promote intellectual property protection, including for pharmaceutical patents,
because of its critical role in the rapid innovation, development, and commercialization of
effective and safe drug therapies.
Structure
•World Bank as trustee-- not involved in matters of policy, but repository for contributions
from both governments and private donors
•Small Executive Secretariat jointly staffed by the Bank, UNAIDS and the World Health
Organization to undertake day-to-day management of the trust fund, including soliciting
grant proposals.
•Two-tiered financial structure like a university endowment:
•"core fund" of resources to support any activity falling within the work program and
eligibility criteria
Released by Chairman Rand Paul
15•donors could also earmark contributions for use on their particular priorities, as long as they
fell within the overall purposes and priorities of the trust fund.
•Both “core” and dedicated resources combined in each grant in a way transparent to the
recipient.
Governance
•High-level Governing Council to provide overall strategic direction.
•Donors and representatives of the developing world (serving in their own personal capacity);
•President of the World Bank, Director General of UNAIDS and Director General of WHO as
ex officio, non-voting members.
•Council to fully control all fund decisions, including determining programmatic allocations,
operational rules and procedures, policies and strategies, approving financial plans and work
programs, and attracting additional donations.
Grant-Making
•Governing Council to outline and agree to fund core menu of “best practice” programs,
according to certain quality standards and experience with evidence-based models proven to
work in developing countries.
•Fund to solicit letters of intent from governments and non-governmental
organizations (NGOs), especially faith-based groups, that describe plans to
implement one of more of core models in local areas.
•Applicants to determine which approved packages most appropriate and useful for
local context.
•Models could range from simple prevention and education programs to more
sophisticated, comprehensive efforts that could involve basic care and treatment,
controlled delivery of anti-HIV therapy, medical training, and clinical trials.
•Emphasis on individual and government accountability, behavior change and
abstinence-based approaches.
•Technical assistance to countries and organizations unable to satisfy our criteria in their
letters of intent, so that over time they might also be able to participate.
•Scientific and Public Health Review Committee to perform rigorous technical peer review
process to assess letters of intent.
•International scientific, medical, and development experts drawn from developing and
developed countries and international organizations
•Empowered to make final decisions about feasibility and sustainability of proposed programs
according to criteria for each “best practice” model prescribed by the Governing Council.
•Broad guidelines that spell out the recommended ratio of expenditures on prevention,
treatment, and research the Governing Council would prefer projects follow.
•Demonstration of local leadership and adherence to international standards of financial
accountability and transparency required.
•Preference given to comprehensive plans that involve governments and NGOs working
together.
Released by Chairman Rand Paul
17well. If you have a few moments, please take a look below. Do you have answers
for my questions? Feelings about these issues?
I welcome responses......Hey, I'm a reporter: I ask questions and hope to get
thoughtful answers.
Thanks very very much for your time and thoughtful attention.
Laurie Garrett
[email protected]
***************************************************************
Gregg,
Did you see Newsday's editorial two days ago? Total support for your position
regarding treatment access.
Last night I was in a screaming match with a doc who does work in South Africa. An
American. He actually said, "I don't give a fuck about microbicides! I don't
give a fuck about prevention! Fuck all you public health assholes! This is about
what is morally right --- treating. Fuck everything else! Bitch!"
Unbelievable.
It is absolutely amazing to me that the classic Public Health v Organized
Medicine dichotomy has so deeply divided the AIDS community all of a sudden.
Correction: the do-gooder community of Westerners. I haven't heard many African
voices chiming in on this one.
Why the hell is there any dichotomy? Haven't we learned anything from all the
mistakes made with TB, drug resistant bacteria, vaccine campaigns......? Jesus!
I have never seen a moment so desperately in need of leadership. Somebody needs
---- IMMEDIATELY --- to call an emergency scientific meeting, with a very
very focused agenda, super-fast. We need:
- Assessment of the validity of the Harvard model. And of other HAART treatment
models. With emphasis on AFRICAN reactions and desires to said model (and not
just five African academics who have been collaborating with Americans or
Europeans for years. REAL people, who toil in thankless jobs in horrible clinics
all over the continent.)
- Assessment of the questionable validity of a few assumptions in that report,
including:
- HAART is a public health measure because is lowers transmissability (oh
really? ALL studies of the matter at the Human Retrovirus meeting showed that
there was no clear correlation between blood viral load and semen or
Released by Chairman Rand Paul
18vaginal viral loads. Do we really know this is true? We have ONE study --- The
Rakai survey. That's it.)
- HAART will, to quote Sachs, "save millions of lives". Really? But we now
have 3 studies on large patient pops. showing the life expectancy benefit
of HAART in USA and Europe is perhaps as little, on average, as 1.5 years,
no more than 5 years. That's not even a "saved life" in cancer terms, as in "5
year survival rates". When grim data came out a year ago critics charged that
the high failure rates were due to large populations of Americans who were
getting diagnosed and treated in late stage HIV infection. Well, now we have
changed the treatment reccommendations to specifically say that later
stage treatment is preferable --- so much for that explanation, no? What
really, truely, is the statistically valid efficacy of HAART?
- In terms of the pentultimate concern that I believe (I hope) is the bottom
line for all sides --- SAVING LIVES --- what would be the impact of a massive
spending commitment aimed at:
- cleaning up the blood supply (less than 10% of which globally, according
to WHO, is currently screened for Hep B, C and HIV)
- global large scale distribution of autodestruct nonreuseable syringes and
MANDATORY coupling of all injectable drug and vaccine products with such
syringes. In other words, if a vial of measles vaccine contains 10
child doses, if should be vaccum sealed to a slab of cardboard on which are 10
autodestruct syringes. Talk about immorality! How in the world can ANY
humanitarian, medical or UN agency POSSIBLY justify distributing vaccines in
countries with greater than 5% HIV rates without attaching enough
autodestruct syringes to ensure that EVERY SINGLE CHILD receives a sterile
injection? I have seen this with my own eyes ---nobody can BS this one. I have
been in African villages where 20 kids were vaccinated with the same
"single use" plastic syringe. And I have been in Ukarianian hospitals
where syrgines were passed from child to child like candy. Consider these
points:
- Russia estimates that by 2006 12% of her population will be HIV+,
and nearly all the infected will be under 29 years of age, IVDUs. It's
not a sexual epidemic --- YET --- in Eastern Europe and ex-USSR. The
opportunity to stop that part of the pandemic COLD is there. It's easy. It's
mass access to autodestruct syringes. And it's this question: which
societal concern should guide HIV policy --- hatred of narcontics users,
or fear of the virus? Am I wrong about this?
- CDC just released a report indicating there were 19 BILLION (yup)
medical injections last year globally, some 90% of which were
unnescessary. And 80% in Asia were nonsterile, 75% in SS Africa and
70% in ex-USSR. PHYSICIAN DO NO HARM: why the hell hasn't anybody
asked what %age of this pandemic is nosocomial, iatragenic?????
Released by Chairman Rand Paul
19 - creating a prize --- say, $10 million --- as incentive to the first
scientific team that develops a truely safe and effective vaginal microbicide
that can be affordably mass produced. (Total global current
microbicide R&D is now less than $50 million, as far as I can tell.) Would that
work? Just how large an intellectual problem is anti-HIV microbicides? Isn't it
a helluva lot easier than coming up with a 90+% effective preventive vaccine?
So, we're working on that vaccine --- FINALLY. Why not a serious
commitment to the microbicides, too? (Is it the word "vaginal"?)
- linking treatment tightly with prevention education, in a quid pro quo
manner (tax payers are subsidizing your HAART, and you are free to live
without prejudice or discrimination, stay healthy and continue to have a rich,
full life. BUT, you must in return understand you have a social responsibility,
and cannot knowingly do anything that might spread your virus to others. This
includes females, who, you African males disdain and consider subhuman. This
includes male & female prostitutes who you pay to accept risk.) I know of no
rigorous case controlled study done anywhere in the world that asks whether
or not this will work. Have I missed them? But clearly, in the USA and Europe,
a very significant %age of HAART recipients feel NO social obligation
---- why else would we have resurgent syphilis, gonorrhea, HIV and a national
14% DRUG RESISTANT HIV rate?
What I'm really asking here is whether the fine difference between
"treatment" and "cure" can be fully understood, and integrated into
behavior, without intense counseling, etc. Obviously we have problems
with comprehension here in the richest country in the world, especially among
college educated white middle class males.
- reassessing the results of the Levine Report and the seeming tendency for
everything at NIH to revert. Would a serious recommittment to
addressing long unanswered basic science questions be in order right now?
- before we start mass distributing HAART, do we know:
- which of the drugs are heat sensitive? What is the half life of a
protease inihibitor that is stored under a tin roof in 90% humidity
at consistent ambient temperatures above 90 degrees F? Are there Cold
Chain issues with any aspects of HAART or OIs treatment?
- which of the drugs have interactions with antimalarials? With
antiparasitics? With rotgut booze? with other drugs that have
undergone chemical change due to storage in above conditions?
- what percentage of the target populations have TB, and what %age of
deaths in the local HIV pop are due to TB? Do we know everything we
need to know to guide co-treatment of TB and HIV with TB-DOTS and
HIV_DOTS?
- why TB DOTs has largely failed globally, resulting in MDR-TB strains
surfacing in 112 nations over the last 6 years (when it was limited
Released by Chairman Rand Paul
20to less than 10 countries before then)? Do we really know how much of
that failure is due to insufficient monetary support, how much to
infrastructural failure and how much to the DOTs model, itself, in varying
cultural and political settings?
- which HAART combos are least likely to lead to multiple drug
resistance, or cross resist- ance and how that compares with the cheap
combos proposed by CIPLA and MSF, etc?
- what key factors have, for the last decade, prevented distribution
of the Essential Drugs lists in most African countries? (Hint: it aint got
crap to do with the cost of the drugs, prices set by manufacturers
or WHO policies. It has everything to do with corruption, black markets,
Russian mob, bad roads, lack of ship off-loading capacity at ports,
warehousing in high heat, etc etc.)
- WHY AFRICA? OK, I'm asking a rhetorical question here. But if global
distribution of HAART makes sense for ssAfrica, why not also for Vietnam?
Ukraine? Cambodia? Russia? Estonia? Is it a question of a certain cut-off, such
as "societies with greater than 10% HIV+ rates?" Or 5%? Who has the right to
make that decision? What are the moral issues here? Do white doctors from
America and Europe get to choose which HIV poor populations on earth get to
have freebie drugs? Does WHO decide? MSF? YOU?????? (If I were an AIDS doc in
Bombay or Kiev right now I would be mighty pissed off....).
- If, indeed, Senegal, Uganda, Thailand and Brazil have not only lowered
their mass HIV rates, but sustained lowered levels, what worked? (From my
observations in Uganda I would say the lowering was transient, and it is now
resurging in much of the country. It was not sustained. Senegal never did have a
high rate: why? All of west Africa has lower rates....why? Many believe it has
little to do with prevention programs or drug access, and everything to do with
male/female power balance issues and female access to the cash economy.) Jon
Mann for ages had a mantra: if a prevention effort works, why? and why isn't it
immediately replicated elsewhere?
- Why were all the questions raised in opposition to phase 3 vaccine trials
not raised for largescale HAART? Remember when NIAID decided to can Phase 3
vaccine studies? The reasons were not so much about the likelihood the vaccines
would work (nobody thought they would), but concerns that people who received
the vaccines would then put themselves and their partners at higher risk, based
on the assumption that they were at least somewhat protected. That was shouted
from the rafters, and continues to be a huge issue. NIH and CDC have spent loads
of money trying to figure out how to counsel vaccine volunteers, what to say
about safe sex, etc. It has been an ENORMOUS concern in the vaccine arena ---
well in advance of actually having a product worth testing. But with HAART?
Bupkiss. Nada. Zilcho. This seems a glaring contradiction bordering on mass
hypocrisy.
Released by Chairman Rand Paul
21OK, that's my venting for the day.
I try to report the truth. I strive for balance. It's getting harder because
everybody is fudging the truth now. Everybody is letting their agendas guide
policy ---NOT the science. For the most part, as far as I can tell, the science
has never really been done. Please, prove to me that I've merely missed it.
Laurie
April 15 – 20 – Trip to Uganda
TRIP TO UGANDA
April 15 – 20, 2001
April 15 – Leave Washington, DC
April 16 – Arrive Entebbe/Kampala at 7:00 PM
April 17 – Spent the day touring medical facilities and making patient rounds at various
hospitals and facilities in Kampala. Jack Killen (Director, Division of AIDS, NIAID)
was my traveling partner.
Started the day off by meeting with Nelson K. Sewankambo (Dean, University of
Makerere School of Medicine. Went off to the Mulago Hospital Antenatal Clinic
escorted by Professor F. Mmiro, a charming and enthusiastic 50-ish OB-GYN doc and
Laura Guay, a pediatrician. This was a most extraordinary experience. I witnessed and
interacted with large numbers of Ugandan women who come to the clinic for antenatal
care. If they request, they are screened for HIV infection and counseled. Most of them,
although they come to the antenatal clinic, deliver at home unless there are complications
such as twinning or toxemia. The percentage of HIV-positivity among them used to be
>40 percent. Now it is approximately 20 percent. The physical nature of the clinic was
that of open rooms connected to outside virandas. The clinic was packed. Many women
looked healthy, but several clearly had HIV disease. Since no treatment is available, no
one from among the clinic patients gets treated for HIV. If they can pay something, they
get treatment for OIs and many get prophylactic Bactrim. Patients who can pay fully will
get reasonable care. I had to hold back my tears.
Next we went on to the Makerere University (MU)-Johns Hopkins University
(JHU) Project that is heavily funded by NIAID. We were shown around by Laura Guay
and Phillip Musoke Mudido, a Ugandan physician. Laura is extraordinary. She is an
American woman who has been in Uganda for 13 years. She is single and has adopted
(or at least supports) a few Ugandan children who are AIDS orphans. They showed me
around their clinical research projects.
Next went to the U.S. Embassy to meet with Ambassador Martin Brennan, a 40-
ish man who appeared extremely interested and knowledgeable about HIV in Uganda. I
Released by Chairman Rand Paul
22discussed with him the NIAID initiatives as well as my recent interactions with Secretary
Thompson, the State Department, NSC, Domestic Policy Council, and the White House
concerning the development and implementation of a White House and US Government
policy and plan of action for treatment of HIV in Africa and AIDS care in Africa. At the
meeting was Ms. Dawn Liberi, USAID Chief for Uganda and Jonathan Mermin, a CDC
person assigned to the US Embassy. Excellent meeting. Extraordinary security related to
the terrorist attack on the Nairobi Embassy last year. We could not even take cell phones
into the ambassador’s office.
Next went on to the Joint Clinical Research Center (JCRC) escorted by Peter
Mugenyi and Cissy Kityo. Like Nelson Sewankambo, Peter is clearly an important
physician in Uganda and the JCRC does much clinical research on HIV/AIDS. It was
unclear how patients get put on a protocol and are followed at JCRC versus getting
admitted as a regular patient to Mulago Hospital. The JCRC is the source of many of the
important clinical studies that have come out of Kampala. I was impressed by the
sophisication of their operation. Many Africans and some expatriots (mostly Americans)
work here and also at other facilities that I visited including the Rakai Project (see
below). Most Staff (PH.Ds, MDs, MPHs and even technicians have spent some time
learning techniques and theory in the USA.
Next went on to make Ward Rounds in the Department of Medicine at Mulago
Hospital with Roy Mugerwa and Harriet Mayanja. This was clearly one of the defining
moments of the trip for me and changed the way I think about the reality and potential of
AIDS care and health care in general in Uganda and Africa since Uganda is considered
one of the best. The wards were packed; people were lying in hallways, in open air
virandas, and some were waiting with their families to gain admission. Most looked
extremely ill and cachectic. Others were reasonable fit, but obviously acutely ill. I have
rounded on thousands of patients over the years, but I have never seen anything like this
except maybe when I made rounds at the King Edward Hospital at the University of
Natal in Durban, South Africa in July, 2000. The difference here is that virtually no one
gets treated specifically for their disease because of lack of anti-retrovirals and inability
to pay even for drugs for OIs, TB and malaria. The rule (with few exceptions is that if
the patients cannot pay something (even a dollar or 2), then they get no specific
treatment. If they can pay, but are poor, they do “cost sharing” whereby they pay for part
of what is to be done (i.e. chest x-ray, medications, etc.); however, it is severely limited
by the amount which they cost share. If you are relatively wealthy and can pay, you go to
a different ward and anything is possible diagnostically (chest x-ray, CT, blood work)
and therapeutically (ARV, OI treatment, etc.). I saw patient after patient with HIV
disease (mostly diagnosed not by serology since ELISA was too expensive - $4.00) and
OIs. Overwhelmingly, patients had active TB. Here again, diagnosis was made
clinically without chest x-ray and frequently without sputum smear and culture.
Certainly, no CTs, bronchoscopies etc. I remember specifically a 17 year girl who had
HIV disease (diagnosed by wasting and oral thrush) and likely cryptococcal meningitis
(dx made clinically); they were considering doing an India ink stain on CSF, but decided
not to since they could not do anything for her anyway since she could not afford
amphotericin or fluconazole. The plan for the patient was hydration, analgesia and
Released by Chairman Rand Paul
23discharge home to her mother. It was tragic! Again, I could barely hold back tears. A
similar case was that of a man in his 30s with obvious HIV disease and likely
disseminated TB. Again, no specific therapy. It hit me like a truck! We were here in
Uganda talking about the possibility of AIDS care now that drugs would likely be
available at markedly reduced prices for Africa (see other discussion regarding tidal wave
of movement to provide drugs). The problem that was clear to me was that even in the
Mulago Hospital, which is one of the best in Africa there was not even basic health care!
Imagine (see below) in the rural areas where there are hardly any doctors. In addition,
what kind of training were the house staff getting when they could not definitively
diagnose and certainly only rarely treat anyone? It became clear to me that we must use
the enthusiasm about providing AIDS drugs to Africans to catalyze an effort to address
fundamental health care in Africa. Even in the best of places (Uganda), there is hardly
any health care infrastructure.
April 18 - Visit to Rakai. Went with Jack Killen (who was with me throughout the entire
trip). Leading the trip was Nelson Sewankambo, David Serwadda, T Lutalo, and F.
Wabwire. This was one of the highlights of the trip. NIAID funds, in collaboration with
Makerere University, Columbia University, and Johns Hopkins, a project in the Rakai
district of Uganda (southwest of Kampala towards the border with Tanzania and
Rwanda). The project has been going on for about 13 years and has been the source of
many major papers including most of Tom Quinn’s work on the role of STDs in HIV
transmission, the relationship between viral load and transmission in discordant couples,
and the protective effect of circumcision on transmission of HIV, among other studies.
The site was inspiring, particularly the dedication of the staff who were mostly young
Ugandan MDs, PH.Ds, technicians, nurses, etc. Also included among them were a few
dedicated American expatriots who were either permanent or doing a fellowship (usually
out of Hopkins). Of note, were Noah Kiwanuka, a Ugandan, born in Rakai, who went to
medical school in Kampala and received his MPH from Hopkins. He was as good as
they get and clearly was in command of the project. Also of note was Mary Meehan, an
American wife, mother of 3, and a scientist who had been living with her journalist
husband in Uganda and working at both the Uganda Virus Institute in Entebbe and the
Rakai project.
Of particular note on the trip was the level of available care in this district, which
made Mulago look modern. I visited the Kalisizo hospital as well as a “subdistrict” anti-
natal and general medical clinic. There was almost no physical access. The best of the
roads were almost impassable. There were large ruts and gigantic potholes in the
unpaved road. Even with a four-wheel drive van, we barely made it since it was the rainy
season and segments of the road were partially washed away. I will never forget the
patients that I saw at Kalisizo and the rural clinic. There were benches full of patients
waiting to be registered and hallways full of people waiting to be seen. Some patients
were tended to by their families and were lying on the walkways and hallways or on the
lawn without a bed. The pediatric ward had 2 children per bed. I was told that among
their other diseases such as HIV and TB, the majority of the people in the wards,
especially the children, had malaria. I say several children being transfused for malaria-
induced anemia. Now in 2001, the blood supply is well-screened. I can only imagine
Released by Chairman Rand Paul
24how many children got HIV-infected years ago before blood screening by these
transfusions given for malaria. The faces of the patients were haunting. They were very
quiet; no one made a sound, even the most ill. The Kalisizo hospital was staffed by 3
MDs whose training was medical school and 1 to 2 years of house staff training. These
people did everything that did not absolutely require secondary and tertiary care. They
performed deliveries, Caesarean sections, abdominal surgery (including bowel resection
and anastomosis), fractures and other trauma as well as some types of chest surgery.
With all due respect to their dedication, I thought at the time and still do now that despite
the fact that on-the spot training is critical, these people could not be highly skilled
surgeons since the only formal training that they had before they came to this place was a
course in “surgical techniques” in medical school. This involved resecting bowels of
sheep and other animals. There was no senior attending here supervising them.
An important point about the visit was the extraordinary sophistication and
dedication of the staff of the Rakai Project. They were amazingly organized in their
system of following patients on study. They had a large number of counselors and field
workers who went out into the field and tracked and counseled their patients. They went
out by truck, motorcycle or on foot. They were mostly young Ugandans who were
clearly dedicated. The success of the projects clearly depended on them.
April 19 – The meeting entitled “AIDS Care in Africa” started today and I gave a brief
opening address that I had carefully prepared with a written statement and slides that I
had asked Greg Folkers to immediately post on the NIAID Website after the talk (please
see copy of speech). Given the tidal wave of enthusiasm of getting antiretroviral drugs to
Africans, there was in the global community immediately prior to this meeting a major
dichotomy between those who were concerned that providing treatment would suck off
resources from prevention and other activities and those who felt that we should proceed
vigorously towards treating African with anti-retrovirals now that the prices of drugs
were markedly decreased. It was clear to me from my reflections before the meeting (see
my speech) and from my 2 days of observing first-hand the situation in Kampala that
there needed to be a balance between treating Africans and accelerating the prevention
measures. Also, and extremely important was the fact that as mentioned above, there was
hardly any health care infrastructure in Uganda (which was better than most African
countries). I stressed that we must act in a comprehensive manner by building
sustainable health care and research infrastructure and by also considering other basic
health care issues such as clean water; treatment and prophylaxis for malaria, TB;
vaccinations against childhood diseases; treatment of diarrheal and acute respiratory
diseases. My remarks were extremely well received and clearly the meeting organizers
and participants were pleased that I was there and were looking to me for sober
leadership in this difficult problem.
An interesting event transpired at the morning session. Ugandan President
Museveni was scheduled to speak immediately before my talk. He was late and so I gave
my talk and chaired the session for about 1 ½ hours. Just at the end of the question
period, the President walked into the Ballroom of the Sheraton Hotel where the meeting
was held. He was accompanied by his Chief Deputy Dr. Ruhakana Rugunda. Everyone
including myself left the stage to make way for the President. I took a seat in the first
row of the audience. Just then, Dr. Rugunda stepped down from the stage, grabbed my
Released by Chairman Rand Paul
25arm and led me to the stage saying that the President very much wanted me to sit down
next to him during his speech. I was told that the President has long been an admirer of
me and respected all that I had done for AIDS. The President greeted me with a
handshake and began his speech by recognizing me to the audience. After his speech, Dr.
Rugunda asked me to say some words. I extemporaneously spoke into the microphone
directly to the President and told him that he was a model of African leadership and that
he was highly respected in the USA and throughout the world for his sensitivity, insight
and leadership in the fight against AIDS, and that we often refer to the “Uganda Model”.
I told him that when I returned to the USA part of my responsibility was to report back to
my Minister of Health, Secretary of DHHS, Gov. Tommy Thompson and the staff of the
White House. I said that I would tell them that what we have heard about President
Museveni was true and that you were indeed an inspired leader and that we look forward
to continuing to work with him. He was obviously very pleased with my remarks and
gave me a hearty handshake and a very warm smile.
At dinner that night, The Rockefeller Foundation hosted a working dinner for
several of the participants to discuss the meeting. I was asked to serve as rappateur for
my table and we had lively discussions about where we go next in this process.
April 20, 2001 - Last day of meeting and my day of departure. Discussions continued
and we all realized how difficult it would be to accomplish this lofty goal of providing
antiretroviral therapy for Africans. There was good news during the meeting that the
consortium of drug companies had withdrawn their ill-advised lawsuit against South
Africa for trying to distribute drugs outside of patent restrictions. Now the South African
government (which has been extremely problematic at best with President Mabeki
showing bizarre behavior regarding whether HIV causes AIDS) would have to move to
start treating their people since the drug companies could no longer be considered the
obstacles.
Lincoln Chen of the Rockefeller Foundation gave a very nice summary of the
meeting as the last speaker and used many of my direct quotes from my talk and my
discussions to make important points. One in particular was my warning to beware of the
“ethical police” who would only want us to do studies in Africa that would be acceptable
and relevant in the USA. This centers around the issue of the Declaration of Helsinki
which states that the control arm of any trial in a developed country (or anywhere) would
have to be the best possible therapy for the disorder. By “best possible therapy”, they
mean best anywhere. This would make research to answer questions that are relevant to
Africa virtually impossible. We all agree that high ethical standards are necessary; but to
demand the best therapy anywhere as the control arm in a nation where there is virtually
no health care and which would not be relevant to Africa is unrealistic. Everyone in the
audience agreed and gave me a long applause.
After the meeting, we drove to the Uganda Virus Institute in Entebbe on the way
to the airport to visit Dr. Sylester Sempala, a well known Ugandan virologist whom I had
met previously at a meeting in Naples, and Mary Meehan. It was a nice facility (by
African standards) and the view was magnificent. It was perched overlooking the shores
of Lake Victoria.
Released by Chairman Rand Paul
26This was an extremely important trip for me in that it gave me a first-hand
appreciation of the dire situation in Africa, not only with regard to HIV/AIDS, but also
with regard to heath care in Africa in general. I believe that this trip will change me
dramatically towards a direction that I have already been heading for the past couple of
years. This direction is towards a greater effort and interest on my part in global health.
April 24, 2001 – Spent 30 minutes on the phone with Secretary Tommy Thompson
briefing him on my trip to Uganda. Thompson is getting ready to brief the Cabinet and
convince them that the USA should take a leadership role in the AIDS in Africa initiative.
He mentioned that he will rely very heavily on me to help him accomplish this important
goal.
May 5, 2001 – Important conference call with DHHS. On call was Art Lawrence
(Acting ASH), Eric Goosby, Helene Gayle, ASH-Designate Claude Allen, Jeff Copeland,
Terrell Halaska, Bill Steiger.
We (Me, Jeff Copeland, Terrell Halaska, Bill Steiger) had been working for
weeks on putting together a position paper for Secretary Thompson on the response to the
challenge of AIDS in Africa. UN Secretary General Kofi Annan will come out with a
proposal for a Global Trust Fund for AIDS in Africa in June at a Special Session of the
UN General Assembly. The White House used our White paper as background to get out
front on the issue and announce that the USA would contribute to the Global Trust Fund.
We were told on the call that the Cabinet Council met with Pres. Bush. The Cabinet
Council consisted of Secr. Thompson, Secretary Colin Powell, Carl Rove, OMB Director
Mitch Daniels, Domestic Policy Council Margaret La Montagne, Pres. Counsel
Rodriguez and members of VP Cheney’s office. The decision was made for Pres. Bush
to announce on May 9, 2001 that the USA would contribute in FY 2002 $200 million to
the Trust Fund. However, of great relevance to me and NIH, there would be no new
money. It would all be budgetary offsets. Of the $200 million, HHS would give $100
million, Dept. of State would give $60 million and $40 million would come from the
existing AIDS trust fund. Of the $100 million from HHS $95 million would come from
NIH as a transfer. $65 million would come from B & F, $25 million from NIAID, $5
million from NIH OD and $5 million from cyber security. Of considerable note is that
Bill Steiger mentioned on the call that he was very “grateful for the generosity of Tony
Fauci who has offered to provide the $25 million from his FY 2002 appropriation. Since
NIAID will get a 14.2% increase, when you subtract the $25 million, this means we
would still get a $260 million increase in our >$2 billion budget. It would not be taken
out of the base, but would be a one time transfer.”. The fact is that I had offered to help a
few weeks earlier in my conversation with Terrell Halsaka. By “help” I was not referring
to the Trust fund; I was referring to putting more research money into the AIDS effort in
Africa. There was no way that I offered $25 million for the trust fund. However, I did
not object over the phone since it was obviously a done deal and the President was going
to announce it. It would look very bad if I objected. There was nothing that I could do
but turn this “challenge” into an “opportunity”. In the end, it really is the right thing to
do since it shows leadership in an important cause and our base was not impacted. I will
probably take some heat from our constituencies. However, who can cogently argue
Released by Chairman Rand Paul
29August 2, 2001 – Had meeting at NIH (Building 31, 7A-24 Conference room called by
Richard Falkenrath of the National Security Council who is Ambassador to the Biological
Weapons Convention. Present at the meeting were: John La Montagne, Thomas Monath
(Acambis Co.- Vice Pres. For Research and Med. Affairs), Stuart Nightingale (DHHS),
Robert Mikulak (Director, Office of Chemical & Biological Weapons Convention, Dept.
of State), Carole Heilman (DMID/NIAID), George Poste, Matthew Meselson (Harvard),
Margaret Hamburg, Joshua Lederberg.
Purpose of meeting was to review a White Paper that had been put together as an
internal document for President Bush. The President had just rejected signing the
renewal of the Biological Weapons Convention (BWC) on the basis that it was
unenforceable. Falkenrath was tasked with putting together a briefing document that was
an expression of our interest in the problem, but was an alternative approach to the BWC.
We crafted something that was a “high road” approach indicating that since we cannot
enforce restrictions among committed users and abusers, then at least we can support
biomedical research to provide better diagnostics, therapeutics and vaccines. At worst,
even if it does not help with bioterrorism, it would be useful for mankind.
August 9, 2001 - After much deliberation and soul searching, President Bush decided
and announced that Federal funding would be allowed for research on embryo-derived
stem cells. However, funding would be restricted to work on embryonic stem cell lines
that had either already been established or were in the process of being established (i.e.
the stem cells had already been removed from the embryo as of August 9, 2001). NIH
(mostly in the form of Lana Skirboll) had canvassed the world and found that 60 such
lines were in existence, many in the private sector. The lines were growing robustly and
were established according to the 4 points that President Bush mentioned in his speech,
i.e. they had to be in vitro fertilized embryos that fulfilled the following criteria: 1)
informed consent; 2) in excess of clinical need; 3) not done as a result of financial
inducement; 4) embryos not established for the purpose of research.
The public response was that the far right felt that the President had betrayed his
pledge not to fund research on embryonic stem cells. Several scientists felt that he had
not gone far enough since he restricted granting of Federal funds for further (after August
9) use of embryos to derive stem cells. I felt that Bush went as far as he could go
politically since on the one hand, if he disallowed any work on embryonic stem cells, the
far right would have been happy, but it would not be a sustainable position for the general
public. On the other hand, if he allowed the unrestricted use of embryos that had been
established for in vitro fertilization (even though this was what I hoped he would do), the
conservatives would have damaged him politically. In other words, I believe that he went
as far as he could go.
August 10, 2001 – Secretary Tommy Thompson came to NIH to hold a press conference
to discuss the embryonic stem cell decision. He requested that I be with him on stage
along with Claude Lenfant, Lana Skirboll, Ruth Kirschstein, and Audrey Penn (acting
Director of NINDS). When he asked me to speak, I made a statement thanking him for
his leadership (since he favored allowing funding all along) and also thanked the
President for his courage in making a difficult choice, but one that will allow us to go
Released by Chairman Rand Paul
30forward and do some good for mankind. I also pointed out the important fact that now
we can do head-to-head comparisons of stem cells derived from embryos versus adults
versus fetal tissue. My comments appeared on the front page of the New York Times on
August 11 and a clip of my comments was shown on the Lehr Newshour on the evening
of August 10. I am sure that some scientists will criticize me for saying that the decision
was a positive thing. However, it is clear to me that these types of people are clueless
when it comes to the world of Washington, D.C. Furthermore, the far right will also be
upset since I favored the use of embryonic stem cells at all. I care even less about what
they think of my position. All in all, I believe that this was a good day for biomedical
research. Lana Skirboll deserves much create for turning the President around.
August 12, 2001 – CNN in association with Time Magazine ran a special program on
“America’s Best in Science and Medicine”. I was featured in an 11 minute segment
along with 4 other scientists. This was in association with Time Magazine naming me
one of 18 scientists as “America’s Best in Science and Medicine”. This feature appeared
in the August 26 edition of Time that reached the newsstands on August 13.
August 13, 2001 – Bob Wood (Chief of Staff for HHS Secretary Thompson) phoned and
said that Secr. Thompson and President Bush have been discussing my turning down of
the NIH Director’s job and they want me to reconsider and to name my own conditions
including maintaining my Directorship of NIAID and virtually anything else I wanted.
August 14, 2001 – Terrell Halaska (Deputy Chief of Staff to Secr. Thompson) called
with almost identical pleas as that of Bob Wood (see above). She mentioned that I am
frequently mentioned at the White House and that the President wanted very much for me
to be NIH Director. I told Terrell that I did not want to do this and explained to her that
my reasons were similar to those 12 years ago when I said no to President Bush (the
elder), i.e. I wanted to work fulltime on the AIDS epidemic and on Global Health and
Infectious Diseases. She was very understanding and was quite complimentary to me,
saying what an honor it was to work with me. Clearly, the phone call went well.
August 15, 2001 – As I had promised, I called back Bob Wood and told him exactly
what I had told Terrell Halaska. Bob also was very understanding.
August 20, 2001 – Secr. Thompson spends entire day at NIH as part of his week at NIH.
I presented to him on Global Health and Vaccine Development at NIH. Also, Gary
Nabel and I gave him a tour of the NIAID Vaccine Research Center.
August 21, 2001 – Attended a meeting at the White House of the Policy Coordinating
Committee of the Biological Weapons Conference group. Chaired by Robert Joseph
(Special asst. to the President) and Richard Falkenrath (Deputy to Condolezza Rice).
Present at meeting was Ambassador Donald Mahley, Special Negotiator at State
Department for Chemical/Biological Weapons, as well as representatives from Justice
Dept., State, DOD, DHHS (me, John La Montagne, William Steiger), etc. Purpose was
to review document that the group put together (White Paper) as a policy that the
President will articulate in association with the USA refusing to re-certify the Biological
Released by Chairman Rand Paul
31Weapons Conference. The paper takes a high road approach about how to handle this
problem, while recognizing that much of what was contained in previous agreements was
unenforcible. John La Montagne and I had contributed to the scientific components of
the white paper.
August 23, 2001 – Secr.Thompson on a visit to NIH again offered me the position as
NIH Director and said that the President wanted me and that I could indeed be NIH
Director, NIAID Director, and keep my Lab. I told him that I wanted to remain doing
what I was doing at full speed and so refused his offer. He was extremely gracious and
quite complimentary to me. He said that I was the most outstanding person that he had
ever met ….really. He said that he would not ask me again unless I brought it up.
Sept. 11, 2001 – Day of infamy. I was in New York City at the time of the attack on the
World Trade Center. Below is a note that I sent to Andy Saxon (in response to his
concern for the safety of me and my family) after returning to Washington, D.C. that
explains what happened:
Dear Andy:
Thanks for the note. I was actually in New York City about 30
blocks from the World Trade Center in a taxi cab getting ready to go to
a meeting of the Doris Duke Charitable Foundation at the precise time
that the first plane hit. By the time I got to the meeting in mid-town
Manhattan and went into the building, I saw on TV the second plane hit.
It was the most horrible day of my life. I was not hurt nor was I ever
in any danger; however, it is an experience that I will never forget.
As you know, my father lives alone in New York, but his apartment is
about 70 blocks uptown from the WTC and he is fine. Also, as you know,
my girls go to school in Washington, D.C; however, they are reasonably
far from the Pentagon. They saw the smoke from their classrooms on the
grounds of the National Cathedral and as expected were emotionally
traumatized. All DC schools were immediately dismissed and the
children went home. However, Jenny, Megan, and Alison (not to mention
Chris) were very frightened since they knew that I had just left for
New York City that morning. I could not phone to tell them that I was
OK since all of the cell phones and fixed phones were jammed. Finally,
I got through to them and they were obviously very relieved. I feel
very fortunate. I was stranded in NYC for a while, but finally caught a
late night train out to DC.
Washington is an eerie town right now. Military police are all
over downtown, National Airport is closed INDEFINITELY, and F-16 jets
are flying in combat formation all day and night over the city. The
NIH has concrete barricades at every entrance and if your car does not
have an NIH sticker and you do not have an NIH ID, you could be the
Pope and you will not get on campus. This is true of all Federal
Buildings. As you probably know from the News, the FBI now knows that
there are several cells of terrorists still in the USA with plans to
execute terrorist attacks, and Washington, D.C. is the prime target. I
do not think that things will be the same around here. What a terrible
situation for us and the world.
Again, thank you for your concern.
Best regards,
Tony
Released by Chairman Rand Paul
32September 17 – 20 , 2001 - I have been called to several top secret meetings over a 4
days period at the White House with the National Security Council (NSC) in a group
chaired by Richard Falkenrath (see other notes) to discuss short and long range plans for
how to handle a bioterrorism attack, particularly one of smallpox. Also, several meeting
in top secret format were held at DHHS in the Humphrey Building. People at the DHHS
meetings include Stewart Simonson (Chief of Staff to Claude Allan), Scott Lillibridge,
Claude Allan (deputy Secretary), Tom Month of Acambis company that is making
smallpox vaccine, D.A. Henderson (Hopkins), Kathy Zoon (FDA), Ann Agnew (Exec
Sec. OD/DHHS, John La Montagne (NIAID), James Meegan (NIAID), Bill Raub
(DHHS), and others. Check files. At the White House (Chaired by Richard Falkenrath,
Deputy to Condi Rice) there was Avis Bohlen (State), J.D. Crouch (Defense), Kenneth
Justice )Commerce, Kathy Zoon (FDA), John La Montagne (NIAID), Bill Steiger
(DHHS), Don Mahley (State), Michael Chertoff (Justice), General John Parker (Defense),
Peter Jahrlin (Defense) and others. Check with John La Montagne and other notes. We
discussed and provided ‘White Papers” a) to justify our not agreeing to the renewal of
the 1992 Bioweapons Convention because it is un enforcible and would also hinder our
legitimate scientists workiing on biomedical research on these organisms. b) justification
for not destroying the smallpox stores since we need them to do research to counter
effects of a smallpox terrorism attack with diagnostics, vaccines, and therapy.c) Short
and long range plans for countering an immediate or distant bioterrorism attack.
September 17, 2001 – While I was at DHHS for the smallpox meetings, Secretary
Thompson called me in his office and said that although he had said that he would not
ask me again to be NIH Director unless I brought it up, he said that he had to do so now
since “…the country needs me, particularly during these stressful times. I want you very
much and President Bush wants me very much”. Although I had been resisting this for
months (and years) (see above), I felt that I could not refuse this call to duty. Thompson
said to name my conditions. I wrote them down and deliver them to him the next day on
Sept. 18. The conditions were: 1) Dual roles as NIH Director and NIAID Director; 2)
Additional staff; 3) Direct access to him; 4) Good faith discussions regarding plans that
he has to do administrative restructuring (centralizing) at NIH OD and away from the
individual institutes such as budget, human resources, etc. I felt that particularly budget
and to a lesser extent HR centralization would not work; 5) $300,000.00 salary ; 6)
Continue to do editing with royalties (especially HPIM) and remain on Board of Trustees
of the Doris Duke Charitable Foundation. The Secretary agreed on all of these except he
decreased the salary number to $295,000.00. I told him that I accept the offer. He will
send all of this to the White House to clear that they also accept these conditions. I do
not expect anything to happen soon given that we are headed to war and likely additional
terrorist attacks.
September 24, 2001 – Yet another visit to the White House, this time to review the final
document on Biological Weapons Convention (BWC) Alternative Concepts. We agreed
on the document to be sent forward to Condoleezza White and Colin Powell.(see hard
copy files). Attending the meeting were: Robert Joseph (WH), Avis Bohlen (State), J,D,
Crouch (DOD), Kenneth Juster (Commerce), Claude Allen (DHHS), Tony Fauci (NIH),
Released by Chairman Rand Paul
33Bill Steiger (DHHS), John La Montagne (NIH), Kevin Chilton (Joint Staff), Ken Baker
(DOE), Alan Foley (CIA), Don Mohley (State), Michael Chertoff (Justice)
September 24 – Oct.10 – Multiple meetings at White House and DHHS regarding
response to Bioterrorism. Anthrax cases (3 thus far) identified in Florida. USA on
“heightened alert”.
Oct. 10, 2001 – Met at St Regis Hotel in Washington, D.C. with Secretary Thompson;
Secretary of State for Health, UK Mr. Alan Milburn; Minister of Health of Canada, Mr.
Allan Rock; Secretary of Health of Mexico, Julio Frenk to discuss international
collaborations in Public Health related particularly to the response to bioterrorism.
Claude Allen and Tommy Thompson appoint me chair of a committee to advice on
technical matters related to smallpox vaccine manufacture, testing and application.
October 8-21, 2001 – Historic, breaking news every day. New York City, Washington,
D.C., Florida are targets of mail-related anthrax cases. As of Oct. 21 there have been 9
cases of anthrax – 1 death from inhalation, 2 serious inhalation anthrx and 6 cutaneous
anthrax with about 40 documented “exposures:. Check news clips for accuracy.
Secretary Thompson appointed me Chair of the Vaccine Technology Team to determine
the scientific and technical feasibility of upscaling the production of smallpox vaccine –
see Memo of October 17 (Wednesday) from ASF to Claude Alan (Deputy Secretary,
DHHS).
Within this period of time there has been major inconsistencies regarding the
“grade” of the anthrax involved in the above exposures. I have spoken with USAMRIID
current and former scientists, particularly Co. Peter Jahrling. He has examined the
material from Sen. Daschle’s office and finds that it clearly is finely milled and what he
would consider “weapon grade”. He told me that it was better than any bioweapon of
anthrax that the USA has ever made. He believes that it was from Iraq. To my
amazement, Gov. Ridge (Penn) was recently appointed to the Cabinet-level post of
Director of the Office of Homeland Security and he went on television stating that he was
told by scientists (likely CD and/or Army people that this was “garden-variety” anthrax;
that is was sensitive to all antibiotics and that it was definitely not weapon grade. I was
floored. I called back Peter Jahrling and he said that he looked at under low power and it
looked like a clump, which would suggest that is was crude and not weapon grade.
However, when he looked under electron microscope he saw pure spores that were finely
milled. He hydrated the system and the spores became totally suspended and remained
so which is the definition of weaponized. Clearly, someone is intentionally not telling
Gov. Ridge the truth or he is masking the truth. The obvious potential reason is that the
USA does not want to deal right now with the obvious conclusion that the material came
from Iraq. I have been trying to cry the warning. I mentioned this to Terrell Halaska
(Deputy Chief of Staff to Tommy Thompson) as well as to Stuart Simonson of
OGC/OS/DHHS. I also hinted to Tim Russert, Sen Lieberman and Sen John McCain
who were my co-guests on “Meet the Press” on Sunday, Oct. 21, 2001.
I believe that there will be hell to pay when the American public realizes that they
have not been dealt with in a totally open manner.
Released by Chairman Rand Paul
34Oct. 8 - 17, 2001 – Thompson asks me to chair a “Vaccine Technology Team” to provide
scientific and technical feasibility with pros, cons, and recommendations on how to
expand the existing smallpox vaccine stores and develop new, additional stores. See my
Oct. 17 memo to Thompson.
Oct. 21 – 22, 2001 – More cases of inhalation anthrax, most recently in a DC Postal
worker who did not touch the Daschle letter, but who was only in the central Post Office
Building where the letter was initially sorted. I am convinced that this is very high grade
material. I in good conscience cannot refrain from bringing this to the attention of DHHS
forcefully. I spoke to Stu Simonson (Oct. 21) and told him that he must tell Secretary
Thompson of my concerns. I also mentioned this to Frank Sesno (CNN) who has called
me at home because of the concern that there may have been an exposure at CNN since
they have contracted a private environmental firm to monitor their offices. They received
a tentative positive ID for anthrax in the environment and called me. I told Frank that he
must report this to the CDC and gave him the appropriate number. He did so and is now
working with the CDC. On Oct. 22 at a CNN morning appearance, I saw Frank Sesno
again and he wanted to pursue our conversation. I strongly urged him to explicitly ask
Gov. Ridge just from whom he is getting information that this is not weaponized
material. I believe that it is of weapons grade given my conversations with Peter Jahrling
at USAMRIID.
Also, I received a phone call from Sen. Bill Frist who was in NYC. We had both
been on the Diane Rehm Show this AM and he called to ask advice on how to get the
correct message out. I also implored Sen. Frist to look into the weaponizing situation in
the same manner that I did with Frank Sesno. Hopefully this will get straightened out
before all credibility is lost.
See New York Times article of October 22, 2001 by Judith Miiler and Sheryl
Stolberg.
Oct. 23, 2001 – Major problem in that DC Postal workers are enraged that they were not
given CIPRO. They feel that there was not enough care in surveying their Brentwood
mail facility. See news accounts around this time. I directly and forcefully told Sec.
Thompson that Gov. Ridge had either been mislead or was misleading the American
people (which I doubt) regarding the quality of the anthrax spores that had been obtained
from the Daschle letter (see above). I strongly suggested to him that he meet with the
President and with Gov Ridge to emphasize that we cannot serve the public well with
regard to the Public Health if we are not given correct information. Someone at that
meeting leaked this to the NY Times and Sheryl Stolberg called me and heard that I had
“angrily confronted the FBI for withholding information”. I refused to comment;
however, off the record I mentioned that the FBI was not in the room at that meeting and
that I was trying to get Sec. Thompson to demand the truth.
Oct. 24, 2001 – Called to emergency meeting at DHHS. Thompson in a very concerned
state of mind; asked for my help and counsel. We now have reliable intelligence that the
USA will be hit with a major bioterrorism attack within the next several days (from
present to Oct. 31). He appointed me in charge of all vaccines. It was clear that the CDC
was not responding adequately. I was amazed at the disconnect between that CDC and
Released by Chairman Rand Paul
36Stewart Simonson, Michael Osterholm, Margaret Hamburg, C.J. Peters, William Patrick,
James LeDuc, Phil Russell, Les Caudell, Co. Edward Eitzen.
Oct. 31, 2001 – NYC “outlier” women dies of inhalation anthrax. Still no connection
with postal cases. Could this be an outlier of the existing paradigm or the sentinel case of
an entirely new paradigm? Did major media today with The Today Show with Katie
Couric, Grand Rounds at NIH covered by all networks, CBS Evening News, Jim Lehr
Newshour, etc.
Nov. 1, 2001 – Had extraordinary briefing of Democratic Senate Caucus on bioterrorism.
Present among others were Sens. Lieberman, Daschle, Boxer, Mikulski, Cleland,
Hollings, Wellstone, Jeffords, Biden, Wydan, Levin, etc. In all there were about 30
senators. They were extraordinarily complimentary to me for my public leadership on
bioterrorism, calling me an “American hero”, a national treasure, etc. I thoroughly
briefed them. They felt strongly that I should lead the nation’s efforts. I politely
suggested that I prefer my present job.
Nov. 2, 2001 – Important Senate Hearing of the Labor, HHS Subcommittee chaired by
Tom Harkin. Also present were Sens. Spector, Byrd, and Stevens. Hearing on smallpox.
I was able to communicate to Specter that NIAID was not allowed to put in a request in
the $1.6 billion supplement of DHHS for bioterrorism. In other words we needed $153.7
million additional to the PB, but we were not allowed to submit for the supplement by
OMB. I “busted” the budget by telling Specter after the Hearing what we needed. He
promised to put it into our appropriation.
Nov. 3, 2001 – There was a spoof on me and Attorney General Aschroft on “Saturday
Night Live”. No new cases of anthrax. Kathy Nguyen case in NYC still a mystery.
Nov. 4, 2001 – I appear on “Face the Nation” with Sen. Ted Kennedy and others; also on
CSPAN’s Washington Journal and CNN Special. No new issues.
Nov. 5-12, 2001 – relatively quiet re: bioterrorism. No new cases.
Nov. 13, 2001 – Went to an extraordinary dinner at the home of the Saudi Ambassador to
the USA (Prince Bandar bin Sultan bin Abdul Aziz) Sat at table with his wife Princess
Haifa Al Faisal (Late King Faisal’s daughter). Also at the table was CIA Director George
Tenet and Sen. Ted Stevens. Dinner in honor of Nelson Mandela. The Princess
specifically mentioned me as a very honored guest when she introduced the program.
Nov. 13- Dec.1, 2001 – At
first no connection with spores in mail However, careful detective work has indicated
that this might be a tertiary mail contamination that gave inhalational anthrax, which is
not supposed to happen. Letter that passed through Trenton with the Leahy letter got
contaminated and went to a post office in CT. may have gotten a letter that
was next to the secondary contaminated letter. Check news stories for details. I appeared
Released by Chairman Rand Paul
37in virtually every newspaper and TV with statements. Washingtonian Magazine choses
me as one of Washington’s “Best and Brightest” – Dec, 2001 issue.
Secretary Thompson told me that over the past week and ½ he has spoken to Pres. Bush
about appointing me Director, NIH. Apparently, there is some resistance by Sen.
Brownback who is a born-again Christian and right winger. He is pushing Bob Redfield
and other strict conservatives. Apparently, he believes that I am too liberal because of
my association with gays in the AIDS work and because of my statements about the
scientific need for embryonic stem cell research. Thompson re-iterates my conditions for
taking the job. Science advisor Jack Marburger is against my doing dual job.
On Nov. 27 and 29 I appeared before 2 Senate committees. On Nov. 29, I testified that
we needed $200 Million (professional judgment) more than the PB. Jeff Koplan (CDC
Director) testified with me that CDC needed an additional $2 Billion for bioterrorism
research. We both made big NY Times and Washington Post coverage. My picture in
NY Times on Nov. 30.
Weekend of Dec. 1 & 2 – Thompson asked me to prepare talking points for him in his
visit to the Pres. To argue against reneging on the promise to give NIH $4 Billion in
FY2003 to complete the doubling trajectory.
Dec. 4, 2001 - Probably one of the most significant days for NIH and me regarding the
budget of the institution. Word was that the “pass back” for NIH would be $0.5 billion,
which would be devastating for NIH (no new initiatives and $275 shortfall on Type 5s). I
entered into intensive negiations with Tommy Thompson over a 2-3 hour period in his
office during which time he frequently called the White House discussing our
negotiations. The bottom line is that Tommy and the President wanted to give the NIH a
pass back that I would be able to publicly defend to the constituents, the Press, and the
Congress. I laid down some strict conditions of this support. It was $2.0 billion for NIH
excluding bioterrorism. I calculated that it would take $1.3 billion to reach current
services, $200 million for maintenance of campus (including security). This would leave
about $500 for new initiatives. On top of that I needed 1.0 billion for bioterrorism. They
wanted to know my opinion of whether the constituents would accept this “almost”
meeting the doubling trajectory. I told Tommy to tell the President that I would
definitely defend this pass back since it actually was a great deal given the constraints on
budget due to the demands of the war and the bioterrorism (BT) defense. I gave him my
word that I would support him and the President.
Tommy also informed me that a few people in OMB were very pissed off at me
because I testified at the 2 Senate Hearings (especially the Specter Appropriations
Hearing) that we needed $200 million more in FY2002 for BT. He also re-affirmed that
Sen. Brownback was not in favor of my nomination for NIH Director because he felt that
I was too liberal and he wanted his candidate who is Bob Redfield, a born-again
Christian. Tommy said that the President wanted me , but was getting pressure from the
far right. I am perfectly comfortable with this situation. I am what I am. Take me or
leave me. I am happy with what I am doing now.
Released by Chairman Rand Paul
38 Dec. 7, 2001 - Negotiated with Ed Sontag (Asst Secr. For Management at DHHS)
regarding restructuring and consolidation of the NIH from an administrative standpoint,
i.e. Budget, HR, Legislation, Procurement, Public Affairs, Grants Management, IT, etc. I
had an agreement with Tommy Thompson that Budget should be sacrosanct and should
stay in the ICDs as opposed to consolidating at the level of NIH. Ruth Kirschstein
(Acting Director, NIH) almost gave away the farm in the negotiations. I stepped in and
took over the meeting for NIH. Ruth was about to agree to give up 850 FTEs. I insisted
that we could not cut down by any more than 200. Sontag came down to 275; we agreed
upon 250. Also, Sontag was concerned that the new Clinical Research Center was
projected to be $142 million over. Ed asked how we were going to handle it and Ruth
said that this did not happen on her watch and that it was someone else’s fault at NIH and
she would see that this person (Steve Ficca) would be held responsible (?fired). She gave
no indication how she would handle the real problem except to say that she would take it
out of the IRP. I insisted that we would need major flexibility from the Department
regarding how we could make up this money and that we could not hurt the IRP so
abruptly and severely. Sontag agreed to help. Poor Ruth is in way over her head. I will
have to make some difficult decisions if I become NIH Director about keeping her on as
Deputy. I may need to appoint another Deputy and have her keep her title, but not her
responsibilities.
Dec. 8, 2001 – Thompson tried to call me at home last night (Friday), but I was out. He
called me on Saturday in my office and told me that President Bush has agreed to appoint
me NIH Director. Thompson wants me to speak with Sen. Brownback to try and
alleviate his concerns about my position on stem cells, embryos, etc. I will set up to meet
him next week. Thompson wants to make announcement before Christmas.
Dec. 12, 2001 – Met with Sen. Brownback and his aide Rob Wassinger. Brownback was
concerned about statements that I made 13 years ago! Concerning the then new SCID
mouse that could be reconstituted with fetal tissue to regenerate a human immune system
in a mouse. I stated at an ACT-UP meeting in NYC that this was a promising area of
research and that it would require the use of fetal tissue. At the time there was the
beginning of a moratorium by President Reagan and later Bush on the use of fetal tissue
for transplantation into humans. I apparently (reported in the press) urged the ACT-UP
people to make their concerns known so that this could be taken into consideration by the
administration and lawmakers. Brownback and Wassinger said that several “right-to-
lifers” had called them very concerned that I was being considered for NIH Director
when I had been a vocal advocate for the use of fetal tissue.
I had a lengthy (1 ½ hour) discussion with Sen. Brownback about embryonic stem
cells, fetal tissue, etc. I believe that the conversation went as well as could be expected.
He was very cordial, but concerned about “how I would advise the President if I were
NIH Director”. I told him that I do not advise the President on Ethical or Moral issues
since I trust that the President has his own strong moral compass. I mentioned that I am a
scientists and that I merely give him accurate scientific facts and he can make up his own
mind within the framework of his own values. I think that Brownback respected that
answer. We left with his still being concerned about me, but I do not think that he will
try to block me.
Released by Chairman Rand Paul
39Dec. 14, 2001 – Spoke with Rick Klausner about his perception about NIH Director.
Rick feels that the WH is not leveling with Thompson since he has heard that they think
that doing both jobs (NIH and NIAID) is a “non-starter” and they are against it. There is
a disconnect here since Thompson feels that they (WH) will accept this, and he merely
needs to get the Brownback issue out of the way. Something is strange here since
Thompson is talking about getting the President to announce me before Christmas and
Rick says the “rest of the WH” is against this. Stay tuned.
Dec.15, 2001 – Sat. meeting at NAS regarding recommendations of giving anthrax
vaccine to people who were exposed to anthrax and who are just finishing their 60 course
of antibiotics. I, Jeff Koplan, D.A. Henderson, and Kathy Zoon (FDA) playing major
role of setting policy and advising the Secretary.
Dec. 16-19, 2001 – Much controversy and last minute scrambling in getting the consent
form and the protocol out for the discretionary use of anthrax vaccine in exposed people
who had been receiving antibiotics, but who are coming off their 60 day course. The
CDC is really relinquishing their responsibility of doing a good job with the informed
consent. They handed us a piece of junk as a draft. Stewart Simonson (Counsel to Secr.
Thompson) has asked me to help get it right. I had been working all day and into the
night on Dec.16-19 revising the consent forms and helping people get straight why
DHHS is offering the vaccine to people. The Press are very suspicious and as usual
critical of the Administration. I have exhaustively reviewed the data (with Cliff Lane as a
great help) and come to the conclusion that vaccine + antibiotics is no better than
antibiotics alone for post-exposure. Yet, Dr. John Eisold (the Navy physician who takes
care of Capitol Hill people) is insisting that the Senate staffers also get the vaccine. We
are in a dilemma. It is true that there is a “theoretical” reason to make the vaccine
available in that animal studies show persistence of spores weeks after antibiotics and
there is a fear that after antibiotics are discontinued the disease will occur. I would not
take antibiotics. However, Eisold and the Senate Staffers are demanding that they get the
anthrax vaccine. In fact, I received a phone call from Ms. Laura Petrou from Senator
Daschle’s staff on Dec. 19, 2001 enraged that we were taking so long in getting the
vaccine to the staffers. Apparently, D.A. Henderson and Tommy Thompson had told
Daschle that the vaccine would be available 2 days ago. They were insistent. The blacks
in the postal service are quite skeptical. I have insisted that if I am going to help we must
not “recommend” the vaccine since the data in animals show that it is not better than
antibiotics alone. The difficult situation is that politically we essentially have to give it to
the Senate staffers since they are demanding it. If we give it to them and do not offer it to
the postal workers, we will be accused of racism and not treating the postal workers
equally. Remember that they were outraged that the Senate staffers got antibiotics right
away and the postal workers only got antibiotics after 2 people at Brentwood died.
Therefore, we are offering, but not recommending the vaccine for any of the 9000 people
who were put on 60 antibiotic course. We are not explicitly telling the public that this is
really the rationale for what is going on. There is some confusion as to why we are not
recommending it and if we are not recommending it, why are we even offering it. I have
Released by Chairman Rand Paul
40tried to articulate this to the public as I did on a Dec. 19 appearance on Jim Lehr’s News
Hour.
Dec. 19-24, 2001 – As expected, publicity went bad for HHS on the anthrax vaccine
story. Washington Post writer Ceci Connelly keeps blasting HHS and particularly
Tommy Thompson and the CDC for lack of clear guidelines. The mostly black postal
workers for the most part refuse the vaccine, saying that they do not trust the government
and do not want to be “guinea pigs”. They completely miss the point that no one really is
telling them that they should take the vaccine. In contrast, the staffers from Daschle’s
office have a high % of people who are taking the vaccine.
Dec. 27, 2001 – Receive a letter from Sen Brownback dated Dec. 19, 2001 in which he
states that he is “deeply concerned by your inability to define the entity created after the
successful procedure referred to by some as human somatic cell nuclear transfer
(SCNT)…” He wants me to respond. I do not want to put anything in writing and so I
call his office and ask to speak with the Senator. His unbelievably right wing staffer, Rob
Wassinger, answers and says that they will not put the call through to the Senator and that
I should answer the questions in writing. Clearly, they are trying to trap me and clearly
Wassinger is an asshole.
Jan. 6 – 22, 2001 – Clearly, it is unclear what is going on with the White House and my
nomination. Secretary Thompson keeps pushing the President to appoint me and the
President defers to Clay Johnson, Director of White House Personnel, who has actually
never interviewed me. I get word indirectly from Scott Whitaker, Bob Charrow and
others that there really is a political battle going on in the WH with a strong anti-
Thompson faction led by Clay Johnson who does not want to appoint me because he
wants to put down Thompson who is pushing me. On the other hand, there are those who
clearly want me, but are less aggressive in pushing any agenda since they are assuming
that I will get appointed. It is unclear what role Sen Brownback is playing in influencing
Clay Johnson. I hear from Rick Klausner that the issue is just that they are reluctant for
me to do two jobs simultaneously. I doubt this and believe that there is something else
going on.
Jan.22, 2001 – Finally, I get called to the West Wing of the WH to meet with Clay
Johnson and Ed Moy (Johnson’s deputy) to discuss the job. Johnson was cold and
abrupt. He said that the President was getting confused messages about my “conditions”
for the job and the POTUS had asked Johnson to clarify things. Johnson coldly and
abruptly asked how I can do 2 jobs simultaneously. I explained about the extraordinary
overlap in what the NIH Director must know and do with what the Institute Directors
must know and do and tell him that I feel that I will have no problem doing this. He
clearly was not convinced. Then he wanted to know why I wanted 2 full salaries, i.e. the
NIH Director’s salary and the NIAID Director’s salary. I explained that this was not the
case, and that I merely did not want to lose money by relinquishing my retention bonus
that I could not take as NIH Director as well as several outside activities that I could not
do as NIH Director. He acted (coldly) like he understood that. As soon as I answered
these 2 questions, he abruptly said: “Well, you answered my questions and told me what I
Released by Chairman Rand Paul
41need to know. Thanks a lot and have a nice day”, whereupon he ended the meeting.
Never did he even approach asking what my vision for the NIH was or other related
substantive questions. Clearly he had made up his mind before the meeting and was only
meeting because the President had asked him to.
Jan 24, 2001 – Tommy Thompson calls me at home at 9:30 PM (he was sequestered in
“the bunker” for security reasons) and tells me that he spoke with Clay Johnson today
and Johnson told him that he was going to recommend someone else and not me to the
President. Thompson was clearly very angry and sad. I am more convinced now that this
is a Clay Johnson agenda working here.
Jan. 26, 2001 – I go to the Annual Alphalfa Dinner at the Capitol Hilton as a Guest of
Robert Wood (“Woody”) Johnson IV.. Amazing scene! Virtually every important
government official (the entire Cabinet, military leaders, etc) was there. At the reception,
I met Barbara Bush who was very warm with a hug and kiss and told me that she is
“pulling for me”. I did not pursue this since this is not my style. I then met former
President Bush who was his usual wonderful self with me, hugging me and telling guests
who were standing around that I had won the 1988 election for him when he told the
world that I was his hero. I mentioned that we had just received the President’s Budget
for FY2003 this week and that the President has fulfilled the promise to double the NIH
budget and had given NIAID and additional $1.5 billion for bioterrorism research. I told
Bush that this was similar to what he, himself, had done with me in the 1980s when he
increased my AIDS budget, but that this was on a much larger scale. I told him how
much I appreciated this. He told me to make sure that I tell the POTUS this.
I also saw Tommy Thompson at the dinner and walked into the ballroom with
him. He seemed very sad and troubled. He again said that he was going to see the
POTUS next week and will tell him that I am not only the best person, but the “only”
person for the NIH Director’s job, regardless of what Clay Johnson will tell him.
At the dinner Woody Johnson brought me over to the head table to say hello to
the POTUS. Bush greeted me warmly (he clearly knew who I was). I thanked him for
the BT money and he asked about our efforts; I briefly told him. He then surprised me by
asking whether I had seen Clay Johnson yet, and so he knows that the meeting was set
up. I told him that I did see him a couple of days ago. The POTUS said “Good, I will
touch bases with Clay next week”. Later on I met Laura Bush and she too complimented
me on my work and we had a very nice conversation. In none of these encounters did I
mentioned the NIH Director’s job. My feeling at this time is confirmed that the President
really does not know the situation except that he has heard a lot about me, but this is
confounded by the fact that it is clear that Clay Johnson does not want me. Is it really
because he is against 2 jobs, or is there some hidden agenda. I feel strongly that it is the
latter. We shall see….maybe.
Feb. 4, 2002 – An editorial in the Washington Post calls for President Bush to
appointment me as the NIH Director.
Feb. 5, 2002 – Spectacular day! I traveled on Air Force One with President Bush to
Pittsburgh to spin his FY2003 budget on Bioterrorism and to visit scientists at Univ. of
Released by Chairman Rand Paul
42Pittsburgh who are working on a novel early warning system for BT. I met the group at
Andrews Air Force Base and flew up at 11:00 AM. Did not see the President on the
flight up; however, spent considerable time with him in Pittsburgh. The motorcade trip to
and from the Pittsburgh airport was exciting. I was in a van about 4 cars behind the
President and the motorcade was heavy with Secret Service and Police. The President
was extremely complimentary to me during the visit as he spoke to other people about me
in front of me. He specifically thanked me for my great work in his speech that was
covered by CNN. During the flight back to DC he called me to his state room and spent
the entire flight back speaking with me!!! In the room were Gov. Ridge, Secretary
Thompson, and D.A. Henderson. Thompson mentioned to me in Pittsburgh that they
spent much of the trip going up to Pittsburgh talking about me and the work that I have
been doing. Tommy is pushing hard with the President to appoint me.
Feb. 8, 2002 – Sheryl Stolberg suggests in the New York Times that Bush should appoint
me. She mentions that the sticking point is my requirement to do both jobs.
Feb. 15, 2002 – Laura Meckler wrote a piece for AP on the right wing Family Research
Council opposing my nomination for NIH Director based on my philosophy on fetal
tissue and stem cells. They refer to my comments in 1988 about the utility of the SCIDhu
mouse model.
Feb. 23, 2002 – Article in New York Times by Sheryl Gay Stolberg telling the story as it
happened saying that I am no longer a candidate for NIH Director’s job. She states that
the White House says that the reason is the objection to the 2 jobs, while the social
conservatives say that my views on abortion and stem cells make me unacceptable to
them. Also, mentions the Sen. Brownback story. Key article since it is factually correct.
Mar. 5, 2002 – Secretary Thompson called me today and said that he was very upset, but
I will not be asked to be NIH Director. He said that he was being forced by the White
House to submit Dr. Elias Zerhouni’s name and that he was not happy at all about this.
He stated that as far as he was concerned, I was his number one person at the NIH and he
was looking forward to working with me in the future.
Mar. 9, 2002 – Attended Gridiron Club dinner in Washington, D.C. Spent time speaking
with President Bush, Karl Rove, Clay Johnson, Donna Shalala, Tim Russert, Sam
Donaldson, John Neroponte, Cokie Roberts, etc. The topic was often concern and
dismay on the part of people (non-White House) that Bush was not going to offer me the
NIH job. Most felt that it really was the litmus test issue and not the 2 jobs issue. Clay
Johnson, who I believe is behind all of this, actually volunteered to me that ”Dr. Zerhouni
is no Tony Fauci, but then again, there really is only 1 Tony Fauci”. It is tough for me to
figure out just how much the Social Conservative/Sen. Sam Borwnback issue played in
Clay Johnson’s insistence to the president that I not be NIH Director.
Mar. 26, 2002 – I went to White House ceremony where Pres. Bush announced Elias
Zerhouni as nominee for NIH Director.
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43Mar. 27, 2002 – Went to NYC for Press Conference for the announcement of my
receiving the Albany Medical Center Prize in Medicine, which is the largest prize in
Medicine in America and the second largest in the world to the Nobel Prize. Amount =
$500,000.00.
Mar. 28, 2002 – Big press conference at DHHS for the announcement of the publication
in NEJM of the dilution studies for smallpox vaccine. Also, in same issue of NEJM was
my editorial calling for an open dialogue as to whether there should be pre-emptive
vaccination of ”first responders” or even of the enitre population on a voluntary basis.
D.A. Henderson is not particularly happy about my editorial since he continually has
trouble admitting that a smallpox attack is a danger. Clearly this is related to the fact that
he has devoted much of his professional life to trying to eliminate smallpox.
Mar. 31 – April 6, 2002 – Went on a terrific trip to Africa with Sec. Thompson and a
delegation listed below. We visited Mozambique, South Africa, Botswana, and Cote
D’Ivoire. The trip was designated a Presidential Mission and so we received the royal
treatment. Flew over on an Air Force jet and were received at each country with Secret
Service protection and local military and police escourts via motorcades etc. Visited
CDC and NIH funded facilities. Met with President Joaquim Chissano of Mozambique.
Long conversation with South African Health Minister Manto Tshabalala-Msimang
regarding reluctance of South African government to provide nevirapine to prevent
mother to child transmission (MTCT). I disagree with her stance, but respect the difficult
situation that she is in. She is driven by a need to decide things for herself since she was
one of the original ANC members who were in exile during apartheid and she does not
trust anyone but her own people. She, however, told me that President Tabo Mbeki
respected me greatly and frequently speaks highly of me, During the Stay in South
Africa the Supreme Court of SA ruled that the government must supply nevirapine to
pregnant infected mothers and their newborns according to ACTG protocol 012. Met
with President Festus Mogae of Botswana. He too had heard about me. Met with Prime
Minister of Cote D’Ivoire. Representative people on the trip that I developed good
friendships with in addition to Sec. Thompson and his staff of Bill Steiger, Terrell
Halaska, Dave Boyer, Corina Gardner, Matt Bluhm and others were: Former
Congressmen Ronald Dellums and Ray McGrath, Scott Evertz of the White House,
Congresswomen Barbara Lee (D-CA) and EB Johnson (D-TX), Michael Miller of NSC,
Anne Peterson of USAID, Bill Roper and others.
April 25-30, 2002 – During the trip to South Africa, I spent about 1 ½ hours at dinner
trying to convince her to help President Mbeki change his stance on treatment of HIV-
infected people including pregnant women (see above). Of note, just this week the South
African government has made a major change in their stance. They now allow treatment
for rape victims and soon will start treating infected pregnant women. It is entirely
conceivable that my discussions played some role in this turnaround.
May 23, 2002 – For the past 2 weeks, Mark Dybul, Terrell Halaska and I have been
working on a proposal for prevention of mother-to-child-transmission (MCTC) in
developing nations to present to president Bush who wants to use this as an
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44announcement of a major initiative at the G-8 Conference this summer in Ottawa. Terrell
asked me to put it together for her and I enlisted Mark Dybul who did a great job with
me. I and Terrell had several pre-meetings at the White House Conference Center on
Jackson Place during early May and then today Mark, Terrell and I met with Gary Edson
and Jay Lefkowitz of the WH. To present our plan to save 146,000 babies from being
infected per year for a cost of about $100,000,000 per year. Gary and Jay loved the plan
and will present it to the President within a couple of days. It was a great meeting and
they were very impressed at how we organized the data and the presentation.
May 29, 2002 – I briefed President Bush in the Hamilton Room of the West Wing on the
MCTC plan. Present were Josh Bolton (Deputy Chief of Staff), Andrew Card (Chief of
Staff), Karl Rove, Mr Calio, Gary Edson, Secretary Thompson, Andrew Natsios
(USAID), Terrell Halaska, Christen Silverberg, Jay Lefkowitz and others. The President
liked very much our plan, which I presented to him succinctly, but completely. The
background of the initiative is that Sens. Frist/Kerry are trying to get through a
supplemental Bill on adding more money to the Global AIDS Fund. The President is
against this since he feels that the Fund has no plan and the money will be wasted. This
is the reason that he wants to seize the opportunity of the Congress throwing more money
at us to put forth his own initiative on a concrete proposal as opposed to the vagaries of
the Fund. He accepted my proposal. Interesting dynamics at the meeting in that Andrew
Natsios was upset that this was an HHS proposal and started (quite inappropriately in
front of the President) getting into a turf war where he pointed out that he has an MOU
with the CDC that with regard to AIDS in Africa, USAID has the lead. The President
picked up on this discord and said that the only thing that he knows is that he likes
”Tony’s plan” and that HHS and USAID should work out (with Gary Edson as referree)
how it is going to be implemented. He stated, however, that he wants ”a person” to be
held accountable for the success or failure of the project. To say the least, Sec.
Thompson was angry with Natsios. From my standpoint, the meeting was a great success
since our plan was accepted by the President and he was extremely friendly to me.
June 6, 2002 – I found out at National Airport that President Bush was establishing a
Department of Homeland Security (DHS) that would encompass 160,000 employees with
a budget of >$30 billion by consolidating all activities related to terrorism, including
bioterrorism in one Department. This would mean that $1.748 billion of NIAID money
for FY 2003 would go to DHS.
June 6 – 12, 2002 – Spending a lot of time working with the DHHS and th White House
in trying to hash out the details of legislation that would create the DHS. Everyone
seems to agree that the research would still be done at NIAID under my direction;
however, the money likely will first go to DHS and thenn be passed through or contracted
to me to perform the research.
Also, the President is planning to announce the MTCT program that I helped to
put together in a few days.
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45June 10, 2002 – Had breakfast with Treasury Sec. Paul O’Neill this AM to discuss the
entire concept of AIDS in Africa. We related very well and he received my advice,
consultation very enthusiastically.
June 13, 2002 – Received a call from Richard Falkenrath at the White House who said
that he had heard that I was concerned about the $1.748 Billion going to Department of
Homeland Security (DHS). We wanted to assure me that the money would come directly
to me from DHS and the research would be directed by me. He agreed that the research
should be incorporated completely into the emerging diseases research agenda of NIAID
and not fragmented out. He said that Sen. Kennedy mentioned to the WH that I was
concerned and they wanted to alleviate my concerns.
Interesting intrigue going on. I just got a call from Sue Hardesty of Sen. Richard
Durbin’s office who said that the Senator had heard from Bono (of U2 fame) that I was
against the global AIDS fund and had convinced President Bush not to support it. The
Sen. wanted to know if this were true. In addition, Sue told me that Sen. Frist had said
that he changed his mind and decided not to support the Global AIDS Fund because he
had heard that I was against it. I believe that if this is true about Frist, then he is covering
his ass since he backed down on his promise to support the extra money for the fund. I
know that he backed down because Bush told him to. Now he is trying to make it look
like I am the one against it. It is interesting that rumors are forming that I am involved in
convincing the Pres. that we should not invest in the Fund. I believe that this results from
my being involved in putting together the MTCT plan, which some feel that the Pres.
actually wants to substitute for the increase in the Fund. Of note, Jeff Sachs called me
from Rome last night asking about the same issue. Welcome to Washington!!!
June 13 – 18, 2002 – Extremely busy with putting the finishing touches on the MTCT
proposal that the Pres. is planning to annouce soon. I am trying and succeeding (I
believe) in having them do it correctly, i.e. this is not a substitute for the Global Trust
Fund, but as a comlement to it. Have been working very hard with Terrell Halaska and
Mark Dybul in getting the Pres. speech written and his talking points arranged for the
announcement.
Simultaneously with this going on, I have been working with Stewart Simonson
in trying to get the correct authorization language written for the proposed bill for the
new Department of Homeland Security (DHS). The WH wants me to be comfortable
with it; however, they seem inflexible in that they clearly want the $1.748 billion of NIH
money to go to the new DHS and they want the perogative to set the research agenda.
Richard Falkenrath of DHS assures me that despite this, they want me to run the program
from NIH.
June 19, 2002 – Most extraordinary day!! The POTUS requested that I join him and
Secs, Thompson, O’Neill, and Powell and Sen. Frist and Andrew Natsios at the Rose
Garden Ceremony to announce the MCTC plan that Mark and I essentialy created. I met
with the Pres for about 10-15 minutes in the Oval Office before the announcement. He
was extremely gracious and complimentary. During the announcement, he specifically
thanked me for all that I have done with the project.
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46After the annoucnement, I went with Ari Fleischer and gave a press briefing in the
WH press room on the program.
Importantly, the Pres. asked Josh Bolten to meet with me and get my feel for the
big picture of what the Adminsitration should be doing with AIDS (domestic and global).
Present at the meeting were me, Josh, Margaret La Montagne Spellings, Robin
Cleveland, Jay Lefkowitz, Gary Edson, Kristen Silverberg, Allen Gilbert. Josh asked
whether we should do a Manhattan Project for a vaccine and not invest in international
prevention and treatment. He said that I should assume that money was not an issues and
I should tell them what is ”the right thing to do”. I gave details about the importance of
building a sustainable (low tech) infrastructure of clinics and trained Africans. This
infrastructure could then be used for HIV prevention and ulitmately treatment, but could
also be used for approaching malaria, TBC, and other important diseases. I said that the
USA needs to be the world leader in making international health a driving force in our
foreign policy. If we lead, other countries will follow. Josh seemed genuinely moved
and agreed with me. He even stated that it is his feeling that years from now, this
Administration will be judged by how it handled the International HIV/AIDS Pandemic.
He stated that the Pres. was very sympathetic to me and what he has heard me say on
various occasions, but there is a skepticism that money will be wasted if there is no
accountability. This is also fed by Paul O’Neill and Mitch Daniels. I said that I agree
that we should not do it unless there was strict accountability. We need to have someone
to run the program who could ”kick ass”. Josh and I resonated very well. I believe that
the WH will be calling upon me soon to help with such a strategic plan. In fact, I am
going to proceed to put one together and present to them pre-emptively.
It was a great day!!! I may have accomplished more for global health on this day
than on many, many others put together.
July 7-12, 2002 – XIVth International AIDS conference in Barcelona. – Very important
conference. The science was completely overshadowed by the policy, which in turn was
dominated by the discussion of the incredible numbers and projections for the developing
world. Latest figures are that approximately 40 million additional infections will occur
worldwide by 2010 and up to 70 million dealths will occur by 2020 if serious
intervention (prevention and therapy) are not implemented.
I gave a highly scientific talk and used it to come to the conclusion that we must
implement treatment and prevention for the North and the South. Please see records on
my speeches for the full text of the talk. It was a Plenary Lecture on July 10. I spent
much time with Secretary Thompson and his team (Terrell Halaska, Tony Jewell, Bill
Steiger et al). There was an aggressive demonstration against Secretary Thompson
during his address on Tuesday, July 9. I was with him and predicted to him exactly what
would happen. I had heard from Gregg Gonsalves that ACTUP would demonstrate for
awhile and then allow him to speak provided that he would meet with them afterwards.
He agreed to meet, but they shouted him down and although (as per my suggestion) he
calmly finished his speech, the audience could not hear what he said. This was unlike
Secretary Sullivan in San Francisco when the TV and microphones allowed audiences
(TV and present ) to at least here what he said. I helped Secretary Thompson with the
Press (backstage)immediately after the shout-down. There was an issue that I handled.
During the conference 2 days before the demonstration, at a Press Briefing during which
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47I sat next to the President, the Press asked about needle exchange. Tommy G. Thompson
(TGT) was not briefed on this issue and I told him briefly that we (Fauci, Jeff Koplan of
CDC, David Satcher – Surgeon General, Alan Leschner – Director NIDA and others) had
recommended to Donna Shalala upon review of the scientific data that the Clinton Adm.
allow Federal funding of needle exchange. However, based on objections of Gen.
McAffrie (Drug Czar) and certain Black leaders, Clinton would not allow it. (Of note
Clinton was at the AIDS Conference in Barcelona and publicly stated that he regretted
that decision and wished that he had allowed needle exchange). In essence, I told TGT
that Clinton did not allow it and we (current administration) are not allowing it. This
created a bit of a stir in the press since when asked at the press event (backstage) after the
demonstration, he seemed confused about the dichotomy between scientific data and
policy. I had to come in and explain the issue. I made it very clear that based on the
scientific data, I had recommended that Clinton allow exchange. TGT said that he would
ask Dr. Fauci to go over the data again, which the Press did not buy since they know the
data are absolutely conclusive. It was a little awkward for TGT, but he is going to have
to face the issue that the Bush Adminstration will likely do (and is doing) exactly what
the Clinton Administration did and follow a policy that contradicts the scientific data.
An important event at the meeting was a meeting that I arranged in my hotel (Fira
de Palace) among myself, Mark Dybul, Cissy (?last name) and Peter Mugyenyi from
Uganda. Peter is the Director of the Joint Clinical Research Center (JCRC) in Kampala.
He is successfully treating many Ugandans with antiretroviral therapy (ART). We (Mark
and I) want to use his model to try to implement the plan that Josh Bolten asked me about
(see above and below). Peter showed us his plan of a main center with regional satelites
and subgroups out of the satelites. These are low-tech clinics and each cost about
$30,000.00 which is much less that the proposals that we have heard. I was very
impressed with this and plan to use this as a model to put together a program to present to
the WH (see below)
It was a great meeting for me in that I became even closer (if that is possible) to
TGT. He implicitly and explicitly trusts me and my opinion. I appeared on the Aaron
Brown Show on CNN during the conference and this went extremely well.
July 14, 2002 – C-SPAN’s Washington Journal – I appeared for 45 minutes on the show
the morning after returning from the AIDS conference. I had spent July 7-10 at the
conference and July 11-12 in Genoa as Chair of the International Scientific Committee
that is reviewing the Gaslini Institute for Lorenzo Moretta (its Scientific Director)
July 16, 2002 – Diane Rehm Show – Spent a terrific 1 hour alone on the show with
Diane. I went over the AIDS Conference highlights. I explained about and defended
Secretary Thomspon vis-a-vis the demonstration against him. Also, I defended the
Administration in that I related that they actually are willing to greatly support
international AIDS efforts, but that they require developing nations and others involved
to put forth a strategic plan with accountability, endpoints, projected deliverables, etc. I
received excellent reviews for the show. I have it on tape as a reference.
July 17, 2002 – Meeting at the White House with Gary Edson and Jay Lefkowitz. We
discussed the details and implementation of the MTCT project. Obviously, there will be
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48difficulties with USAID. They are resentful that DHHS is getting involved in
international AIDS issues. Anne Peterson was at today’s meeting. I have no confidence
that she or her staff are capable of successfully pulling off this program. Mark Dybul
alone can do better than their whole group. Sorry for being so direct, but it is true. Of
note is that I brought up to Gary Edson and Jay Lefkowitz the issue that I had discussed
with Josh Bolten regarding the more Global plan of therapy, prevention for HIV and
other diseases in a ”low-tech” manner. I discussed my meeting with Peter Mugyenyi and
Cissy (?last name) from Uganda (see above). I told Jay and Gary that I believe that we
could pull off a program based on the ”Mugyenyi model”. He told me to put together a
proposal in a very short time frame (before the WH leaves for August break ( i.e. <2
weeks). They want to determine if the POTUS could bring this initiative with him on his
upcoming trip to Africa in January, 2003. I will work with Mark Dybul to do this.
July 21, 2002 – Over the past few weeks important issues have evolved regarding
Biodefense. There is a major struggle going on in the Congress about the formation of
the new Department of Homeland Security (DHS). At issue (among other important
issues) is whether the $1.748 billion that is in the President’s budget for FY2003 will be
transferred over to the new DHS and who will actually be responsible for the strategic
plan and prioritization for biodefense. DHS people (Gov. Ridge and Richard Falkenrath)
clearly state that they want the money and the responsibility, but that they will work very
closely with me. The Congress and all of the scientific Societies (FASEB. ASM. Etc.)
say that they want the money and prioritization with me. As usual, I must publicly
defend the President’s position, but I work behind the scenes with people like Sens.
Lieberman, Kennedy, and Frist to get language in the new authorizing Bill that will not
transfer the money or responsibility (let us see what actually happens).
Meanwhile, VP Dick Cheney is pushing for a Manhattan Project approach to
Biodefense. He mentioned this at his visit to CDC and told Julie Gerberding that he
would mention this to me also. Of note, I was quite influential in supporting Julie for the
CDC job. We have CIA intelligence that Iraq has smallpox and everyone in DHHS and
the WH are scrambling to get together an immunization plan that will go well beyond
what the ACIP is recommending (i.e. pre-emptively vaccinate only about 10,000 –
20,000 health workers and rely on ring vaccination in the event of an attack). Cheney is
pushing for a much wider vaccine plan. TGT will present our plan to Cheney within a
few days, which recommends a staged (1,2,3) process that vaccinates about 500,000
health workers from Oct. 02, to December 02 and then from Jan. 03 through the end of 03
vaccinate up to 10 million responders (phsyicians, nurses, police, firefighters, EM people,
primary care personnel). After that and depending on the adverse event rate and the
perception of threat, we will make vaccine available for the entire USA population on a
voluntary basis. One of the reasons for the push by Cheney is that he knows that Iraq has
smallpox and he is planning to push out Sadam Hussein either by direct invasion of Iraq
or by funding the opposition. He is afraid that Sadam will strike Israel or even us if his
back is against the wall. There will be very intense discussions over the next couple of
weeks with the WH and DHHS that involve me regarding smallpox vaccine policy.
Things are obviously very busy with my being involved simultaneously with
Biodefense and International response to HIV/AIDS. Both of these involve my direct
interaction with the White House.
Released by Chairman Rand Paul
49July 22-24, 2002 - Went to the beach (Beach Haven) to link up with family. In the car
on the way up and while I was there, I spent considerable time on the phone trying to
work out with Sen. Spector’s staff (Bettylou Taylor et al) language in the Lieberman Bill
on authorization of DHS that Spector could support. They want to make sure that I am
comfortable with the language. I am trying to get language that give DHS ultimate lead
in the overall prioritization of the research on biodefense, but the money stays in DHHS
and the research is executed by NIH, but the development of the research agenda in done
by DHHS in consultation with DHS. Finally we had a conference call (I took it in the
kitchen of the beach house) among me, the White House (Richard Falkenrath) and the
Senate staff that are marking up the bill. Richard and I agreed upon what I listed above.
Hopefully, the bill will get through with that language. It was important to have the WH
on the phone since I was getting concerned that they might think that I was undermining
their efforts to get the DHS going. By hashing it out with them, we are doing it up front
and honestly.
July 25, 2002 – Had top secret conference call with Jerry Hauer (HHS), Phil Russell
(HHS), Stewart Simonson (HHS), and Lester Crawford (FDA). Subject – VP Cheney has
indicated that we will hit Iraq soon and we expect retaliation with a smallpox attack on us
or on Israel. Cheney wants us to greatly accelerate the process of getting vaccine
available to vaccinate everyone if necessary. I offered to accelerate studies to determine
if we can dilute the Dryvax even more than 1:5 and whether we can also dilute the 77
million doses of Aventis Pasteur WetVax. Stay tuned.
The House and the Senate Committees have adapted the language that I had
suggested to Richard Falkenrath. Therefore, at this time it appears that the money will go
to DHHS, the overall prioritization will rest with DHS, the strategic plan and specific
priorities will be the responsibility of DHHS in consultation with DHS and the research
will be executed by and through the NIH. If this holds, I will have won a big victory.
July 26, 2002 - Got an e-mail from Gary Edson at the WH asking if I had completed the
Global AIDS Treatment plan to present to him in order to determine if it is worth
presenting to the President for him to announce in his upcoming (January) visit to Africa.
Mark and I are finished and we set up a meeting at the WH for Wednesday, July 31. Let
us see what happens.
Had an unusual meeting at the Rayburn Building with Chairman Kolbe (R-AZ) of
the House Foreign Relations Committee and his chief staffer Charlie Flichner. I
accompanied Claude Allen (Deputy Secretary, DHHS). They are very upset at the White
House, particularly Gary Edson, for having the President announce the MTCT initiative
without first consulting with them. They made disparaging remarks about Gary
(”Emperor Edson”, ”President Edson”). They were cautious about being disrespectful
about the President; however, they were pissed. They also disparaged Tommy Thompson
about getting involved in International issues when this is not the purvue of DHHS.
Actually, it is becoming the purvue of DHHS with the CDC’s GAP (Global AIDS
Program). This clearly was a turf issue. They are a powerful Committee and they are
pissed that the President made an announcement without consulting them. Wait until
they hear about the Global AIDS Treatment package that we are presenting to Gary
Released by Chairman Rand Paul
50Edson and Jay Lefkowitz on Wednesday, July 31. I am going to have to relate to Gary
the essence of my meeting with Kolbe and Flichner.
August 1, 2002 – Met at the White House with Gary Edson, Jay Lefkowitz, and Margaret
La Montagne Spellings to present the Dybul/Fauci plan for comprehensive treatment and
prevention of HIV in African countries. This was in response to the original request by
Josh Bolten and then the specific request by Gary Edson to put together a plan based on
the ”Mugyenyi Model ” of Uganda (see July 17 above). Also present at the meeting was
Terrell Halaska, Joe O’Neill, Mark Dybul, and Allen Gilbert. Gary, Jay and Margaret
was extremely pleased and excited about the plan. They mentioned that we had done a
”fabulous” job. They asked us to respond to about 5-6 questions in writing. Clearly they
are going to run it by the President when he returns from his August vacation in
Crawford, Texas. He may well want to make this a Presidential initiative similar to the
MTCT proposal that we had put together for him.
August 16, 2002 – Went back to White House to present the revised Global AIDS Plan
to Gary Edson. Also present were Terrell Halaska, Mark Dybul and Joe O’Neill,
Director of Office of National AIDS Policy (ONAP). Gary again liked the revised plan
and liked how we answered the questions that he and Margaret Spellings posed to us at
the last meeting concerning: a) impact on Domestic AIDS issues; b) development of a
sharp sound bite for the State of the Union Address in case it comes to that; c)
relationship to Global AIDS Trust Fund; d) Inclusion of Russia, India, and China; e)
reason why the Gates/Merck/Harvard/Univ of Penn initiative in Botswana has failed; f)
administrative structure of the program. He asked me to revise the document by
tightening it up to an Exec Summary, 5 pages of text and a group of tables. He wants us
present it to Josh Bolten when Josh gets back from vacation next week. Mark and I can
quickly make this revision.
August 26, 2002 – Meeting at the White House with Gary Edson, Jay Lefkowitz,
Margaret Spellings, Ken Thomas (ONAP), Jim Capretta, Robin Cleveland (OMB) and
Mark Dybul. We presented the condensed version (see above) to Gary , Margaret, and
Jay. Several minutes into the meeting Robin and Jim showed up and in a somewhat
offhand manner without evening knowing the details of what we were presenting, Robin
became very critical of the idea and the project. She actually parroted words that we had
heard weeks ago from the Kolbe Committee (Charlie Flichner) about how they were very
skeptical that we could actually get ”twin pairs” of hospitals. Also, she questioned
whether the Uganda model would work even though she knew virtually nothing about it.
I kept my cool, was subliminally sharp in response to her, but was very pissed inside.
Gary intervened and defended what we had done and indicated that we would come back
to Robin with more details about the Uganda model etc. (which we had already done
among us previously). Afterwards, Gary, Ken, Mark and I met for about 45 minutes in
The Situation Room and discussed further revising of the documents. I would not be
surprised if Robin leaked all of this to USAID and the House Foreign Ops Committee. I
did not like the way she acted at the meeting and I do not trust her. She acted a bit
disrespectful to us in my mind; however, I believe that this was not her intent and she was
reflecting the questions that the House Foreign Ops Committee was asking her.
Released by Chairman Rand Paul
51August 26 – Sept. 5 – Much discussion about pre-emptively attacking Iraq to neutralize
them before they use or get capacity for ”weapons” of mass desctruction. This is pushing
our HHS team to be ready to vaccinate the USA population. Our plan for ”staged”
smallpox vaccination of immediate first responders to broad first responders to voluntary
vaccination of general public is ready to go. We are waiting for word from the White
House to roll out the plan.
Sept. 6, 2002 – Two meetings at the White House today:
1) Meeting in Executive Office Building (EOB_ in OMB’s Robin Cleveland’s office
with Robin, Gary Edson, Joe O’Neill, and Mark Dybul. We presented our re-
enforced implementation with a beautiful computer model of accessibility to
central medical centers (CMCs), primary, secondary and tertiary clinics in
Uganda as a prototype. Robin was still not entirely satisfied with the presentation
since she was hung up on quarantees that this plan would work given failures in
previous endeavors in these countries. She and Gary also wanted to flesh out the
computer model on India, Mozambique and Guyana. We will go back and try
again. Next meeting likely will be with Josh Bolten.
2) Meeting in EOB with General Bruce Lawlor (deputy to Gov. Ridge of OHS), Col
Kadlac (OHS), and Col Gerald Parker of Ft. Detrick for me to present to Lawlor
the NIAID plan for research including collaborations with DoD and facilities at
Ft. Detrick. I presented the NIAID Strategic Plan and Research Agenda. It was a
great meeting. Lawlor was extremely impressed and highly supportive. We
promised to work together and he offered to help in any way possible. He is a
tough, nice , straight shooter. His background is that he commanded a tank
battalion in the Gulf War.
Sept. 17, 2002 – Another meeting at the White House on the President’s AIDS initiative.
This time I presented the program to Josh Bolten in his office in the West Wing. Also
present were Gary Edson, Jay Lefkowitz, Terrell Halaska, Mark Dybul, Joe O’Neill,
Robin Cleveland, Kristen Silverberg, Carol Thompson. We are definitely moving along.
Clearly Josh wants to do it. He thoroughly liked my presentation. The problem will be
OMB and the question of where we are going to get the money. Issue also is if the
President accepts it, when can we announce since the budget for 2002 has not even been
settled and 2003 has virtually decided. We want to announce soon since WHO and other
organizations are dancing around the question of an implementation strategy and we do
not want to President to lose the leadership edge. Josh asked OMB (Robin) to work out a
budget scenario and get back to him. They also will elevate it up one more notch to
Andy Card, Condolezza Rice and Mitch Daniels. We will meet again soon.
Sept. 18, 2002 – Briefed Secretary Thompson about the upcoming smallpox vaccination
policy and role-out. Also present were Julie Gerberding, Stewart Simonson, Michael
Osterholm, Jerry Hauer, Les Crawford, Ann Agnew, Terrell Halaska, etc. We are
advancing towards the 3 stage policy that ultimately would allow voluntary vaccination
for anyone who wants it.
Released by Chairman Rand Paul
52Had briefing at the White House on the fact that West Nile Virus can now be spread via
blood transfusions (and transplants). We are in the midst of a major epidemic with about
1641 cases and 80 deaths. It has been clearly documentd now that blood transfusions can
transmit WNV. We discussed how we would handle the press, etc. I strongly suggested
that we avoid the mistakes of the early 1980s regarding HIV and the blood supply. I
suggested that we obviously try to avoid panic, but that we make it clear that transfusions
are NOT entirely risk free with regard to WNV as well as several other pathogens. It is a
question of relative risk of the transfusion versus not getting the transfusion.
INCREDIBLE evening – Bono the lead singer of U-2 and the best selling musician in
history had called my office yesterday (his chief-of-staff) to say that he wanted to talk to
me by phone or preferably in person to discuss how we could partner and how he could
help me in my work on trying to get AIDS treament and care and prevention to sub-
Saharan Africa. He had, this past year, gone to Africa in a much-publicized trip with
Treasury Secretary Paul O’Neill. At mid-day we got a call that Bono wanted to fly from
Chicago to speak with me in person that evening. He did and we met at my house. We
had wine, Chris cooked pasta and we had an amazing evening, talking for hours. He is
alsolutely fantastic, passionate and very intelligent. He will try to help by supporting me
and President Bush in the evolution of our implementation plan for Africa. Also visiting
was his staff Jamie Drummond, Lucy Matthew, and Katrina...... We promised to stay in
close touch and work together. I did not tell Jenny, Megan and Alison that Bono was
coming to the house for dinner. When he walked in the door, they were speechless;
however, he was wonderful with them. They (and I) will never forget this extraordinary
night.
Sept. 24, 2002 – Had CIA briefing and overall review of smallpox plan in Secr.
Thompson’s office with Gov. Ridge, Col. Bob Kadlac, Julie Gerberding, Jerry Hauer, and
a Ridge person . Clearly Russia had modified smallpox and very likely Iraq has
smallpox. We reviewed the pre-emptive plan for vaccination that will be presented to
Pres. Bush tomorrow by TGT in anticipation that he will make the policy decision soon.
We will recommend the 3 stage proceedure of 500,000 to 10 million to the general
population. Word in the meeting is that we will definitely attack Iraq by January.
Sept. 26, 2002 – White House briefing with Carol Kuntz (Assistant to VP Cheney),
Kristen Silverberg, Stewart Simonson, Jerry Hauer, Bob Kadlac and others regarding
smallpox vaccination policy. Carol was concerned that she was getting different signals
from different people about varying toxicities among children versus adults, primary
vaccinees versus re-vaccinees. Apparently, D.A. Henderson has been very dogmatic with
her (what else is new?). I told her that one can go to the literature and analyze the
information in many ways. Since she questioned my numbers, I just kept quite and
promised myself to get back to her.
Sept. 27, 2002 - Spoke with Carol Kuntz over the phone and explained some
calculations that I had done (see attachment). She apologized for questioning me the day
before and even made the comment that ”Who is she to go mano-a mano with Tony
Released by Chairman Rand Paul
53Fauci” since I am ”a legend” in the White House. I had a great conversation with her and
sent the document shown below to her.
September 27, 2002
NOTE TO CAROL KUNTZ
From: Anthony S. Fauci, M.D.
Director
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Carol:
As per your request, I will summarize below the information that I discussed with
you over the phone and will provide as attachments (1 through 5) some data sheets:
1) The question arises whether the rate of serious complications due to primary vaccinia
vaccination is greater in children versus adults and whether, because children will be
obviously excluded from the cohort of health worker and first responder vaccinees, this
will result in a lower than anticipated rate of complications for the first 2 stages of the
vaccine program, i.e. up to 10,000,000 people. My reference is Lane JM et al:
Complications of smallpox vaccination, 1968. National surveillance in the United States.
N Engl J Med 281:1201, 1969. I worked from Table 1 of the paper (attachment #1) and
analyzed the “Primary vaccinations”. I divided the cohort into 2 groups of <1 yr to 9 yrs
old and 10 through 20+ yrs old in order to compare the actual rate per million
complications in each group. I found the following:
There were 4,900,000 individuals in the <1 to 9 yr olds and 694,000 individuals in the 10
to 20+ yr olds. The rate of complications in the 2 groups were as follows:
<1 – 9 y.o. 10 – 20+ y.o.
per million
Postvaccinial encephalitis 3 1
Vaccinia necrosum 0.4 4.0
Eczema vaccinatum 10 14
Generalized vaccinia 22 26
Accidental inoculation 26 10
Deaths 1 1.44
Therefore, one can conclude from this analysis that the younger group has a higher
incidence of encephalitis, but the older group is similar, if not slightly worse off, when
Released by Chairman Rand Paul
54compared to the younger group with regard to the other complications of primary
vaccination. HOWEVER, the critical issue as I see it is the major difference between
previously unvaccinated and previously vaccinated individuals with regard to the
frequency of vaccine-related complications. Whether you look at the figures from the
1969 paper referred to above (attachment #2) or the 2001 MMWR (attachment #3), the
rate of complications in the previously unvaccinated group is considerably higher than
that in the previously vaccinated group. For example, in the Table 6 of the 1969 New
England Journal of Medicine paper (attachment #2), the complications per million are as
follows comparing previously unvaccinated versus previously vaccinated: Encephalitis –
2.9 versus 0; vaccinia necrosum – 0.9 versus 0.7; eczema vaccinatum 10.4 versus 0.9;
generalized vaccinia – 23.4 versus 1.2. The differences are even more impressive in the
Table from the 2001 MMWR (attachment #3)
2) Since the differences are so striking between previously unvaccinated and previously
vaccinated individuals with regard to the incidence of serious adverse events associated
with smallpox vaccination, I calculated the percent of people in the work force that we
could predict would be previously vaccinated or not. I used the most recent US Census
(2000) (attachment #4). I consider the work force to be individuals from 20 through 64
years old (this corresponded to natural breaks in the census data). In 2000, there were
281,421,906 people in the USA. I found that there were 59 million people or 21% of the
total population and 36% of the work force between the ages of 20 and 34 years. These
people will have not been previously vaccinated. Routine vaccinations stopped in 1972
and most children would not have been vaccinated before age 5 and so 34 years old is the
cut off point. I further found that 107 million people between the ages of 35 and 64, i.e.
38% of the population and 64% of the work force were likely vaccinated. Thus, 64% of
the people that we would be vaccinating in the first responder/health care worker
category would fall into a group that historically has a much lower rate of serious adverse
events than the previously unvaccinated group. I believe that this must at least be taken
into consideration in our policy decisions.
3) You asked a question about residual immunity in people vaccinated decades ago. If
you look at laboratory immunity (i.e. antibody levels and cell-mediated immune
function), there is no question that the vast majority of studies indicate that there are
variable levels of residual laboratory immunity in people who were immunized even
decades ago. The question remains whether the laboratory immunity is totally reflective
and correlated with clinical immunity to an actual exposure. There are several studies
that indicate that previous immunization, even decades ago, provides real, but variable,
degrees of protection against death (i.e. lower case fatality rates) compared to
unimmunized individuals. It is impossible to determine the effect on actual infection
without death. Some of these studies such as the 1902-1903 Liverpool outbreak study is
partially flawed in that there was some smallpox circulating in the community that might
have boosted immunity. However, several studies that are summarized in a paper by
Mack TM et al: Smallpox in Europe 1950-1971. J. Infect. Dis. Vol.125, number 2, Feb.
1972 (attachment #5) indicate that case fatality rates are significantly less in individuals
vaccinated even more than 2 decades before. I personally do not believe that all of these
people were protected because that were intermittently boosted by naturally occurring
Released by Chairman Rand Paul
55smallpox. There just were not that many widespread smallpox outbreaks to boost the
population of Europe consistently during that time frame. In fact, from 1950 through
1971, there were only 680 cases of smallpox in the countries in question. Therefore, I
would have to conclude (not definitively, but likely) that previously immunized people
do have a variable, but significant, degree of residual protective immunity against death
from smallpox.
I hope that you find this information useful. Please give me a call if you have any
questions at (301) 496-2263. Thank you and best regards.
Sincerely,
Anthony S. Fauci, M.D.
Sept. 29, 2002 – Received ICAAC Award and gave the ICAAC Award lecture in San
Diego on “Bioterrorism in the spectrum of emerging and re-emerging diseases”.
Audience was 10,000 people and received rave reviews for the lecture.
Sept. 30, 2002 – Got another top secret briefing from the CIA. Apparently Russia is still
making genetically modified microbes for offensive use. Also, was briefed on Iraq’s
capabilities. It is my impression that the CIA information is really very soft. They have
sources, but they are difficult to validate.
Oct. 4, 2002 – Engaged with Julie Gerberding, Jerry Hauer, Kevin Keane in a briefing of
State and local Public Health officials on the likely roll out plan of smallpox vaccination
in3 stages (500,000 smallpox response teams and emergency personnel, then 10,000,000
health care workers, primary care people, police and fireman, etc. followed by making
vaccine available to general public after the Acambis product is licensed in early 2004.
This was followed by a press conference, which did not go well since Jerry Hauer said
that we were not going to make any “announcements”. Note that there have been many
leaks about the 3 stage plan and the press was clearly annoyed that the press conference
started with a statement that we were not going to tell them anything important.
However, Julie proceeded to get up and say that we recommended the above plan. She
left the stage for a few minutes and I corrected her (politely) by saying that we are not
“recommending” anything, we are merely giving a likely option. The Secretary
recommends something to the President and that is confidential. The reason for this is
that we do not want to put the President in the position of possibly going against his top
health advisors, i.e. boxing in the President. Julie returned and confirmed my correction.
The press rightfully thought that we were sloppy (not me, but DHHS). We called the
main players – Larry Altman, Laura Mackler of AP, Ceci Connolly of Washington Post
and Sheryl Stolberg of NY Times to clarify the situation. All of this is happening
because the WH is taking so long to come out with a policy and we are compromised
because if we do not say that we favor a certain plan, then it looks like we do not know
Released by Chairman Rand Paul
56what we are doing. How can we not favor a certain plan if we have been working on this
problem for months???
Oct. 10, 2002 – Had 2 important meetings at the White House today:
First - meeting with Gary Edson, Jay Lefkowitz and Robin Cleveland about the
comprehensive AIDS implementation plan for prevention, treatment, and care for
developing nations for possible consideration by the President. This was in response to a
call from Jay about 1 week ago asking to spread out the plan from 5 years to 7 years and
to calculate how much money would be spent for each prevention intervention, i.e.
condom distribution versus sex worker education versus needle exchange versus family
counseling. The point is that they feel that the request might be too much for the 5 years
(Total = $9.987 billion over 5 years, including up to $1.0 billion for the Global Fund).
They want us to spread it out so that the early years will be less. Also, they want us to
assume that countries other than Russia, China, and India (which will contribute 50%)
would be contributing some proportion. We figured Botswana and South Africa could
contribute 30% each Namibia and Guyana 20% and Uganda 10%. Furthermore, they
anticipate that the President is going to ask just what the money is going for and if it is
for Condoms, sex workers and IV drug users, he should at least know that. Obviously,
the right wing in the WH would be against this. We crunched the number and I presented
this. Right off Robin mentioned that Jim Capretta (OMB PAD) had mentioned to Mitch
Daniels that something was cooking vis-à-vis international AIDS and that this would
require new money. Mitch immediately said no chance and that no matter what we give,
we will be criticized. Robin then left for another meeting. I suggested to Jay and Gary
that another alternative would be to do this through the Global fund with the stipulation
that they work from our plan with suggestions from them. My reason was as follows. The
WHO group just met in Geneva with Bernard Schwartlander to try to galvanize a plan
and support for a global program. Mark Dybul went to that meeting. It appears that they
will ask for a 3 year plan to treat 3 million people at a cost of $10-15 billion with $4.6
billion from USA. They want to announce this on World AIDS Day (Dec. 1). This could
pre-empt the President. In other words, we will be pressured to give $4.6 billion to do
someone else’s plan. This would be less that our 5 year and 7 year plan. Why not
announce that we will give $4.6 million to the global fund if they coordinate their
activities through our plan? The President could announce this and get credit for
leadership as well as for contributing to the Global AIDS Fund. Also, it would avoid the
impression that we Americans are going off on our own. Gary and Jay liked the plan
very much and asked me to put together a 3-pager for Josh Bolten. They made me swear
to tell no one about this, not even Mark, Terrell or TGT. I finally convinced them that I
really needed to tell Mark since he is necessary to put these things together. I am very
uncomfortable about not telling Terrell.
Second meeting was a briefing of Vice President Cheney’s Staff on the NIAID efforts on
biodefense, i.e. what is our “vision” for spending the $1.75 billion as well as our long-
term vision. At the meeting were Carol Kuntz, Seth Carus and Noreen Hynes (all from
Cheney’s senior staff) and Jerry Hauer (from the DHHS). The meeting went extremely
well. I wowed them with a passionately delivered presentation. I told them that we at
NIAID could transform the way the country deals with bioterrorism threat from a
Released by Chairman Rand Paul
57research and public health standpoint. They loved it and asked what powers I needed that
I do not have to execute this. I mentioned that we should have a fund to purchase
vaccines and drugs so that the pharmaceutical industry would have an incentive to get
involved. Also, I said the FDA needed to be more flexible.
Oct. 17, 2002 – Sent down the 3-pager that Jay and Gary wanted (see above). It calls for
the USG taking the lead and committing a considerable amount of money THROUGH
the Global Trust Fund, but under the stipulation that other countries join us and
implement our plan. The plan would cost approximately $18.8 billion of new money over
5 years. In the covering memo to Jay and Gary, I mentioned that I was uncomfortable
about not telling Terrell what we are doing since I am supposed to me representing her
and TGT at these meetings. Of note, Gary and Jay usually respond almost immediately
to me when I send material such as this. However, over the subsequent 2 days (Oct
18,19), I have heard nothing from them. I suspect that they are put aback by my
mentioned my discomfort about not telling Terrell about this. We shall see what
happens.
Also, received a call from Stewart Simonson who said that Vice-President Cheney
wants a meeting with me about my Biodefence Research Vision on Wednesday, Oct . 23.
The White House has set up the meeting.
Oct. 20, 2002 – Gary Edson contacted me and likes very much the revised document (see
above). We are closing in on it and he will soon show it to Josh Bolten.
Oct. 8 – 22, 2002 – Washington, D.C. area being terrorized by a sniper who has already
shot 12 people and killed 9.
Oct. 22, 2002 – Had a terrific visit and briefing of Vice President Cheney in the West
Wing of the WH. Present were the VP, “Scooter” Libby, Carol Kuntz, Noreen Hynes,
Seth Carus, (Gen.) Phil Russell, and Stewart Simonson. I went over our NIAID Research
Agenda and Strategic plan for biodefense. As I did in my briefing of Carol Kuntz (see
above), I stressed that we can and will do the job. I stressed that we needed help in
getting greater regulatory flexibility, having the power to sole source contracts, and we
need to provide major incentives for industry. We must work more closely with industry
the same way that the automobile industry made our planes and tanks during World War
II. It was a very easy and enjoyable interaction with the VP. Of note, when we discussed
briefly the policy for smallpox vaccination, it was clear that Libby is the driving force for
mass vaccination sooner rather than later. The VP seemed rather measured on the
subject.
On the way out of the WH, I ran into Gary Edson in Josh Bolten’s office (Josh’s
assistant had seen me walking by and asked me to come in to say hello to Josh). Josh and
Gary were actually working on the plan that Mark and I had just sent to them. They like
it very much and I think that something is going to happen with it.
Oct. 23, 2002 – Met with Bono again at the Jefferson Hotel for breakfast. Also present
were Jamie Drummond, Lucy Matthew, Katrina and Erin Chapman. We spent almost 2
hours going over options for how we can drive the agenda for universal care, prevention
Released by Chairman Rand Paul
58and treatment for HIV infected people worldwide. I emphasized the importance of
engaging Russia, India, and China because of the large populations in these countries in
which a mere increase in prevalence from 1% to 2% in countries like India and China (I
billion people in each country) could quickly create a pool of infected people that would
equal all of Africa. He will be meeting with Condolezza Rice this afternoon to push for
the USA getting involved in a major way with money (billions) and leadership. I am
impressed with Bono’s good intentions and his intelligence and energy. I am
disappointed that I cannot tell him about the program that Mark Dybul and I have been
working on for the “comprehensive implementation” plan. Hopefully, we can make this
public soon so that we can engage Bono’s assistance with his bully pulpit.
Oct. 29, 2002 - Received today the written version of the oral history that Victoria
Harden collected from me a few months ago. See attached document.
Fauci on biodefense
8-9-02.doc
Oct. 30 – Nov. 1 – Multiple conversations and e-mail exchanges with Gary Edson
regarding the AIDS Project (see above). I believe that finally we are getting this straight.
Historically (see above), every time that we try to calculate the needed resources for a
comprehensive program, Robin Cleveland (OMB) or someone else says that it will not
fly (see note of Oct. 10, 2002). Now Gary calls me and says that our most recent package
might be low-balling it since he recently read an article by Jeff Sachs in The Economist
that we need $25 billion per year. I finally told Gary that I had had enough. The world is
calling for $10 billion per year for 5 years with an increase to $15 billion per year by
2007. They all say that the USA commitment should be 35% of this or $3.5 billion per
years for 5 years. I told Gary that this is what we should propose as the President’s
initiative provided that the other countries put in the remaining 65% and that they use our
implementation plan. I told Gary that he and Robin need to figure out how much of $3.5
billion per year we (USA) will have already been spending in order to determine the
amount (% of $3.5 billion) that really would have to be new money. Finally, he agreed
and now we can stop all of this ridiculous back and forth with Robin and him. We may
be getting close to presenting this to the President. We just need to convince Josh Bolten
Nov. 1, 2002 – Had a great meeting with Carol Kuntz, Noreen Hynes, and Seth Carus
regarding the request of the Vice President for me to list what added powers that I would
need to make the BioD program work at NIAID. Stewart Simonson and Phil Russell also
present I listed a group of these and Carol et al liked and agreed with them. They were
mostly sole source contracting authority, rapid grants, DARPA-like powers, etc. Next
step is arranging a meeting with me, TGT, and Cheney.
Nov. 12, 2002 – See note of Oct. 30 – Nov. 1 above. Gary Edson called me last week
and said that they were on the verge of making the decision regarding whether we will go
for the major implementation plan. However, there is skepticism on the part of OMB
Released by Chairman Rand Paul
59(and likely others that he did not mention) concerning whether this can be done. They
need to do due diligence and get some outside opinions and so they Gary has asked me to
gather for a meeting at the WH a group of people who have actually done developing
country implementation. They want to speak with these people without my being there,
i.e. to check up on me. I suggested and they agreed to bring in the following: Peter
Mugyenyi (Uganda), Jean (Bill) Pape (Haiti), Paul Farmer (Harvard-Haiti), Eric Goosby
(Pangea Foundation and Rwanda). Gary asked me on a Friday and I needed to contact
these people who were scattered all over the world to come to DC to see me and then
have a visit to the WH. Gary insisted that I not reveal the plan to them and so I had to
convince them to travel within a 72 hours period merely on faith as a favor to me. They
all agreed and came: Mugyenyi from Uganda, Goosby from Rwanda, Farmer from
Germany, and Pape from Haiti. Still Gary insists (despite my asking him again and
again) that I cannot tell Terrell Halaska about any of this. I pushed Gary and he checked
with Josh Bolten who said that this week we indeed will be able to tell Secretary
Thompson.
On another issue, things are heating up regarding possible war with Iraq. This
makes compelling the imminent decision of policy regarding smallpox vaccination of
civilians. The Pentagon will imminently announce that 250,000 to 500,000 troops will be
vaccination with vaccinia (Dryvax). The question of the availability and
recommendations for civilians remains. I am pushing for “recommending” that the
500,000 and then the up to 10,000,000 health workers and first responders get
vaccinating. However, I feel that although we should make available the vaccine for the
general public, given that the threat assessment is very soft, we should recommend that
they not take the vaccine unless they feel very strongly that they do not want to take any
chances. This is different from the situation with the anthrax vaccine where the DHHS
said that had no recommendation either way; they just made the vaccine available if
people wanted it.
Went down to the White House to pre-brief Gary Edson and Jay Lefkowitz on
Mugyenyi, Goosby, Pape, and Farmer. They both inquired as to what pretense I used to
get these people to come to the USA. I said that I asked them to come and advise me
about clinical trials in developing nations.
Had dinner at the Trattoria Sorrento in Bethesda (Cordell Street) with the 4
visitors and told them exactly why I called them in and explained what type of questions
would be asked of them at the WH. They look upon me as a hero for what I am doing.
Nov. 13, 2002 – Multiple meetings in the DHHS to plan roll out of smallpox vaccination
plan. It is imminent. The President is planning on having to start bombing Iraq in the 2nd
week of January and wants to start vaccinating the 500,000 people smallpox response
teams by December 1 and the 10,000,000 first responders by January in order to prepare
for a release of smallpox by Iraq. Much discussion about timing the announcement of
vaccinating the military with the announcement about the general population. Concern is
that if we do not link the 2, the people will react to vaccinating the military by saying
“what about us?” It looked like we were going to make the announcement on Friday,
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60Nov. 16. However, at the WH, the President told the cabinet (including TGT) that he
now wants to wait until he comes back from a foreign trip (Nov. 27) since Osama bin
Laden just released a tape yesterday indicating that he is still alive and threatened the
USA, UK, and Russia. Bush does not want it to appear that we are panicking in response
to the tape. I am relieved that we decided to wait since I would have had to cancel my
going to Los Angeles to receive the RAND Prize ($10,000.00) in order to remain in DC
for the Press.
Heard that the WH meeting with the 4 visitors on the global AIDS plan went
extremely well. I believe that we are convincing the skeptics that we can effectively treat
HIV in developing nations. Of note, Robin Cleveland asked to have Nils Daulaire there
for his opinion. It is my impressions that she is resentful of the NIH and me. This is
likely due to the fact that her OMB account for which she is responsible includes USAID
and there is obviously some competition in her mind given that NIH always does so well
with the budget.
November 19, 2002 – Another meeting at the White House with Jay Lefkowitz, Gary
Edson, Joe O’Neill, Mark Dybul and me to further discuss the potential for getting the
President to accept our proposal for a comprehensive $50 billion over 5 year plan. Gary
and Jay want me to further refine the presentation and actually start finalizing it for
presentation first to Mitch Daniels and then ultimately to President. Jay had shown me a
memo that Nils Daulaire had sent to Robin after the meeting with Mugyemnyi et al and it
was clear that Robin and Nils are working together. Nils is a fine former public servant
and is now in the private sector. However, judging from his memo, he is dead wrong on
certain issues, i.e. he does not believe that Russia, China and India will surpass Africa
within the next 5 years in AIDS impact. Also, I am not happy that Robin previously told
Nils about the plan at the same time that Gary and Jay will not allow me to tell Terrell
Halaska or Secretary Thompson about it. Strange situation in this WH regarding secrecy
– they are almost pathologic about it. At the meeting, Jay and Gary asked me and Mark
to prepare again even more material for an upcoming meeting with Mitch Daniels (see
above). We got it to them within 1 day.
November 21, 2002 – Another pre-roll out meeting at the Department to prepare for the
upcoming announcement by the President on the Smallpox vaccination policy. Meeting
was with Kevin Keane, Bill Hall, Jerry Hauer, and on teleconference - Michael
Osterholm, Julie Gerberding and an assortment of CDC public affairs people. I have
convinced them that we should not recommend to the general public that they take the
vaccine give the non-quantifiable risk. I am also convincing them that for the Stage 2
(10,000,000 first repsonders), we also should not make a blanket recommendation that
they get vaccinated. Rather, we should say that as a group the vaccine should be offered
to them, but since this is a heterogenous group, the actual recommendation to take it or
not should rely on discussions between the CDC and the State and local public health
officials in light of the particular needs and situation within a given jurisdiction. Clearly,
the Stage 1 group (500,000 smallpox response teams) should have a recommendation to
take the vaccine voluntarily.
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61Nov. 22, 2002 – Gave keynote address at the Holy Cross function at The Supreme Court
for “Lift the Cross High”. Justice Clarence Thomas was our host and was the other
speaker. My remarks were very well received by all. It was a very elegant evening
aimed ultimately at fund-raising for Holy Cross. Thomas is also an alumnus.
Nov. 26, 2002 – Briefing of Vice President Cheney at the White House regarding Project
Bioshield (I made up the name) which is requesting his help in getting me special
authorities for Countermeasure Advanced Development. Meeting included VP Cheney,
“Scooter” Libby (both on teleconference from secret location), Secretary Thompson,
Stewart Simonson, Bill Raub, Carol Kuntz, Noreen Hynes, Seth Carus. Bill Raub
presented the need for a $1-2$ billion Vaccine Trust Fund. Meeting went extremely well.
VP was very supportive of my proposals and told Carol to set up a meeting between me,
TGT, Stewart and Josh Bolten.
Also met later in the day with Richard Danzig (former Secretary of the Navy
under Clinton). He is a private consultant under contract to the DoD for Biodefense and
wanted to get to know me since he has “heard so much about me”. He wants to start an
informal group of people linked by common interest in biodefense.
Dec. 3, 2002 – Still waiting for the President to decide on the announcement of the
smallpox vaccine policy. Should be tomorrow or next day. Also, a lot of back and forth
between me, Jay Lefkowitz and Gary Edson. I believe that we are moving towards a
Global AIDS Initiative. Jay will present our plan and budget to Mitch Daniels today.
Phone call with Jay Lefkowitz and Keith Hennessey and Doug Badger called
wanting to know why we needed a vaccine trust fund as opposed to other mechanisms to
guarantee purchase of vaccines. This is what Bill Raub presented to the VP (see above);
however, they are asking me about it because of “my credibility” (according to Carol
Kuntz. Carol was on the phone with Kristen Silverberg. There is some concern as this
passes through the WH that there is not enough justification for a “Trust Fund”. Carol
Kuntz wants to set up a meeting at the WH for me to help explain this sometime later this
week or next week.
Dec. 4, 2002 – Amazing day. I was at one time on 3 different lines with 3 different
people at the White House – Gary Edson, Jay Lefkowitz, Carol Kuntz. There was an
intense and critical issue with Gary and Jay. Gary was getting ready to meet with Mitch
Daniels regarding our AIDS plan and he heard through his WH grapevine that Mitch was
going to try to “Steamroller” him by bringing up the Washington Post article from a
couple of days ago about the program in Botswana being a failure. In other words, if
Botswana failed, why did we believe that our program would succeed. I explained to
Gary that the Botswana Program was “Top Down” government as opposed to local
network. They were using high tech., approach instead of grass roots. Gary asked me to
contact our African friends and get their opinion (in one half hour!!!!). I contacted Peter
Mugyenyi, Sam Kibende, and Eric Goosby and they all agreed with me. Peter mentioned
that the big mistake that the Gates Foundation and Merck went directly to the Botswana
Government and asked them to put together a plan. Botswana then employed the
Harvard AIDS Institute who developed a high-tech USA Harvard like plan with CD-
Released by Chairman Rand Paul
62ROMs for developing voluntary Counseling and Testing. Peter said that it was doomed
to failure. I relayed this to Gary and he was satisfied.
Also, more delays in the announcement of the smallpox vaccine policy. It will
not be this week and so I will be able to go to Albany to give a talk associated with my
Albany Prize from last Spring.
Dec. 4 – 10, 2002 – Incredible amount of action going on. Many calls and interactions
with VP Cheney’s staff (Carol Kuntz, Noreen Hynes, Seth Carus) regarding Project
BioShield. The VP wants to come to NIH and have me show him around the Vaccine
Research Center (VRC) in the context of the “Advanced Project Development” of Project
Bioshield. Project Bioshield has caught on with the VP and his staff. Scooter Libby is
becoming a strong ally and fan of mine.
At the same time there is a lot of buzz as to when the President is going to
announce his vaccine policy. Many leaks, interestingly most from the WH itself. We are
busily preparing our Qs and As for the announcement.
Elias Zerhouni feeling a bit out of the loop. I am trying to keep him informed, but
the WH and DHHS wants to deal directly with me.
Dec. 11, 2002 – A truly terrific day! Cheney came to VRC and I presented an updated
version of Project Bioshield in the context of going from concept to product in the VRC.
Present at meeting were: Cheney, Scooter Libby, Carol Kuntz, Noreen Hynes, Seth
Carus, Elias Zerhouni, Tommy Thompson, Stewart Simonson, Phil Russell, Gary Nabel
and his staff. Cheney and Libby were “wowed” by my presentation and by the VRC
Cheney instructed his staff to do whatever is necessary to facilitate what I am doing
including giving me special authorities.
Immediately after the VP visit, I rushed down to the WH to present “Project
BioShield” to Josh Bolten in the context of the VP wants me to sell the concept to Josh.
Present at the meeting were Josh, Kristen Silverberg, Richard Falkenrath, Tommy
Thompson, Scooter Libby, Stewart Simonson, et al. Josh questioned the need for the
vaccine purchase fund component of Project BioShield (good questions). I defended it
even though this really is not my bag (Bill Raub was the original designer of it). At the
end of the meeting, Josh seemed supportive of the entire project. Clearly the VP is
driving this process.
Another amazing event. The vaccine policy roll-out is under very close hold at
the WH. Today I received one of my many calls from George Stephanopoulos of ABC.
George pointed out that the President gave an interview with Barbara Walters to view on
Dec. 13 in which he said that he would allow vaccination of the entire population on a
voluntary basis. George thought that this constitutes the long-awaited announcement of
the policy. I told George that the Pres. was probably just speaking in broad generalities
since I know that there will be a formal announcement with me involved at the WH.
George seemed convinced; however, the ABC people pursued this and confronted the
WH who inexplicably confirmed the story and said that the roll-out would be Friday
(Dec. 13). I heard about this when I was in Josh Bolten’s office presenting Project
BioShield. My phone rang and CBS said that ABC had broken the story on the policy on
the basis of the Barbara Walter interview. They wanted me on their show to discuss. I
said that I knew nothing about this and therefore could not appear. I