[Senate Hearing 109-111]
[From the U.S. Government Publishing Office]
S. Hrg. 109-111
BIODEFENSE: NEXT STEPS
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HEARING
BEFORE THE
SUBCOMMITTEE ON BIOTERRORISM AND PUBLIC HEALTH PREPAREDNESS
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED NINTH CONGRESS
FIRST SESSION
ON
EXAMINING THE BIODEFENSE RESEARCH PROGRAM OF THE NATIONAL INSTITUTES OF
HEALTH, FOCUSING ON THE DEVELOPMENT OF MEDICAL COUNTERMEASURES AGAINST
A BIOTERRORIST ATTACK
__________
FEBRUARY 8, 2005
__________
Printed for the use of the Committee on Health, Education, Labor, and
Pensions
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COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
MICHAEL B. ENZI, Wyoming, Chairman
JUDD GREGG, New Hampshire EDWARD M. KENNEDY, Massachusetts
BILL FRIST, Tennessee CHRISTOPHER J. DODD, Connecticut
LAMAR ALEXANDER, Tennessee TOM HARKIN, Iowa
RICHARD BURR, North Carolina BARBARA A. MIKULSKI, Maryland
JOHNNY ISAKSON, Georgia JAMES M. JEFFORDS (I), Vermont
MIKE DeWINE, Ohio JEFF BINGAMAN, New Mexico
JOHN ENSIGN, Nevada PATTY MURRAY, Washington
ORRIN G. HATCH, Utah JACK REED, Rhode Island
JEFF SESSIONS, Alabama HILLARY RODHAM CLINTON, New York
PAT ROBERTS, Kansas
Katherine Brunett McGuire, Staff Director
J. Michael Myers, Minority Staff Director and Chief Counsel
______
Subcommittee on Bioterrorism and Public Health Preparedness
RICHARD BURR, North Carolina, Chairman
JUDD GREGG, New Hampshire EDWARD M. KENNEDY, Massachusetts
BILL FRIST, Tennessee CHRISTOPHER J. DODD, Connecticut
LAMAR ALEXANDER, Tennessee TOM HARKIN, Iowa
MIKE DeWine, Ohio BARBARA A. MIKULSKI, Maryland
JOHN ENSIGN, Nevada JEFF BINGAMAN, New Mexico
ORRIN G. HATCH, Utah PATTY MURRAY, Washington
PAT ROBERTS, Kansas JACK REED, Rhode Island
MICHAEL B. ENZI, Wyoming (ex
officio)
Robert Kadlec, M.D., Staff Director
David C. Bowen, Minority Staff Director
(ii)
C O N T E N T S
__________
STATEMENTS
TUESDAY, FEBRUARY 8, 2005
Page
Burr, Hon. Richard, Chairman, Subcommittee on Bioterrorism and
Public Health Preparedness, opening statement.................. 1
Kennedy, Hon. Edward M., a U.S. Senator from the State of
Massachusetts, opening statement............................... 3
Enzi, Hon. Michael B., Chairman, Commmittee on Health, Education,
Labor, and Pensions, prepared statement........................ 4
Roberts, Hon. Pat, a U.S. Senator from the State of Kansas,
prepared statement............................................. 6
Fauci, Anthony, M.D., Director, National Institute of Allergy and
Infectious Diseases, National Institutes of Health, U.S.
Department of Health and Human Services; Penrose C. Albright,
Ph.D., Assistant Secretary for Science and Technology,
Department of Homeland Security................................ 7
Prepared statements of:
Anthony Fauci, M.D....................................... 10
Penrose C. Albright, Ph.D................................ 22
Painter, George, Ph.D., CEO, Chimerix, INC.; Jon Abramson, M.D.,
Professor and Chair, Department of Pediatrics, Wake Forest
University School of Medicine, Winston-Salem, North Carolina;
Gerald L. Epstein, Senior Fellow for Science and Security,
Homeland Security Program, Center for Strategic and
International Studies; Gordon Cameron, CEO, Acambis, PLC....... 46
Prepared statements of:
George Painter, Ph.D..................................... 49
Jon Abramson, M.D........................................ 54
Gerald L. Epstein........................................ 60
Gordon Cameron........................................... 70
ADDITIONAL MATERIAL
Statements, articles, publications, letters, etc.:
Summary of the President's 2006 budget for Homeland Security. 31
Questions of Senator Roberts to Mr. Albright, Ph.D........... 37
Questions of Senator Roberts to the panel.................... 37
Questions of Senator Enzi to Mr. Albright, Ph.D.............. 44
Generic Pharmaceutical Association........................... 82
Randi Airola................................................. 84
Meryl Nass, M.D.............................................. 87
The Military Vaccine Education Center........................ 91
(iii)
BIODEFENSE: NEXT STEPS
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TUESDAY, FEBRUARY 8, 2005
U.S. Senate,
Subcommittee on Bioterrorism and Public Health
Preparedness, Committee on Health, Education, Labor, and
Pensions,
Washington, DC.
The subcommittee met, pursuant to notice, at 10:05 a.m., in
room SD-430, Dirksen Senate Office Building, Hon. Richard Burr,
chairman of the subcommittee, presiding.
Present: Senators Burr, Roberts, Enzi [ex officio],
Kennedy, Murray and Reed.
Opening Statement of Senator Burr
Senator Burr. I would ask that the subcommittee hearing
come to order. I want to thank you for coming to the first
hearing of the Health Subcommittee on Bioterrorism and Public
Health Preparedness. I am looking forward to working with the
chairman of the full committee, Senator Enzi, the ranking
member, Senator Kennedy, and all the members of this
subcommittee throughout this session of Congress.
I think that we have the distinction of holding the first
Health subcommittee hearing of the year, but I have always
believed that when it comes to bioterrorism, you have to be
ahead of the curve. Already the Senate has before it S. 3, the
Bioterrorism Legislation, introduced by Senator Gregg. I know
that Senator Hatch and Senator Lieberman have also been working
hard on a Bioshield II bill.
Bioterrorism has been an important issue to me for some
time. In fact, I sponsored the first bioterrorism legislation
in the House before September 11. It was obvious to me the
United States had a very real vulnerability to being held
hostage to bioterror. After September 11, it became even more
apparent that the threat was real and the government needed to
work with industry to build up our protection and our ability
to react to any type of an attack.
As a freshman senator, I recognized that many senators
before me have worked very hard on strengthening our Nation's
defense against bioterrorist attacks. I am humbled to have the
opportunity to work with them and many of whom are members of
this committee and specifically this subcommittee.
As I mentioned earlier, as a member of the House of
Representatives, I sponsored the first bioterrorism legislation
in the House, the Public Health Threats and Emergency Act of
2000. I was pleased to help create the Public Health Security
and Bioterrorism Preparedness Response Act of 2002, and
followed that legislation up with the Smallpox Emergency
Personnel Protection Act of 2003.
This subcommittee has a lot of important work ahead of it.
Last year, the Project Bioshield Act was signed into law, but
many people believe that there is a need for subsequent
legislation that will further strengthen the program's
viability. This year we will take up that discussion and
legislative action on this important subject.
Next year, unbelievably, it will be time to reauthorize the
bioterrorism legislation from 2002. The goal of today's hearing
is to examine implementation of Project Bioshield. I believe
that Bioshield has begun to address the bioterrorism threat but
acknowledge that more is needed to fully protect our country.
In order to increase critical scientific effort in the area of
the bioterrorism preparedness, the government must have full
participation in this work from the pharmaceutical and biologic
industries.
I hope that today's witnesses will help us understand what
we can do, what industry can do, to achieve the best working
relationship that benefits the American people.
Our first panel we have Dr. Tony Fauci, Director of the
National Institute of Allergy and Infectious Diseases. Dr.
Fauci is the lead scientist and director of the HHS effort on
bioterrorism.
We also have Penrose Albright, Assistant Secretary of
Science and Technology Directorate at the Department of
Homeland Security. Mr. Albright has been involved in the
national security arena since 1986 and is directly involved in
the implementation of Project Bioshield at the Department of
Homeland Security.
On our second panel, we have Gerald Epstein, a Senior
Fellow for Science and Security at the Centers for Strategic
and International Studies, Homeland Security Program. Mr.
Epstein will give us a broad overview of bioshield
implementation and the private sector's reaction to the law.
We have Mr. Gordon Cameron, CEO of Acambis. Acambis is a
successful biotechnology company with facilities in
Massachusetts. Acambis has produced a smallpox vaccine and will
give us their perspective of the research field pre-Bioshield
and any changes that need to be made since then.
I am especially pleased to introduce the next two witnesses
who are from North Carolina. The main reason they are speaking
today is they are experts in their field. It is just
particularly nice for me that North Carolina has some experts
that I can have testify. Dr. Jon Abramson is the chair of
Pediatrics at Wake Forest Baptist Medical Center. He is a
member of the CDC's Advisory Committee on Immunization
Practices. Dr. Abramson will talk about the need to increase
liability production for pharmaceutical and biologic companies
involved in the areas of research.
Mr. George Painter is the president and CEO of Chimerix, a
small biotech company in North Carolina's Research Triangle
Park. Mr. Painter will talk about the additional research tools
and coordination needed by pharmaceutical and biotechnology
companies in order to successfully produce bioterrorism
countermeasures.
I thank all of our witnesses for their attendance today. We
look forward anxiously to your testimony. I thank the chairman
and at this time I would recognize the ranking member, Senator
Kennedy.
STATEMENT OF HON. EDWARD KENNEDY, A UNITED STATES SENATOR FROM
THE STATE OF MASSACHUSETTS
Senator Kennedy. Thank you very much, Mr. Chairman. The
first meeting of a new subcommittee is always an important
occasion. I particularly commend our full committee chairman,
Senator Enzi, for his decision to devote a subcommittee to the
issue of defense against biological attacks, and I also commend
our subcommittee chair, Senator Burr, for an impressive record
of accomplishment already on this issue. We are off to a good
bipartisan start.
Five years ago Senator Frist and I worked with Senator Burr
when he was a member of the House on the first legislation to
deal with the public health defenses against bioterrorist
attack. That measure was signed into law a year before
September 11, and in the wake of that attack, a more extensive
bill on the issue was enacted in 2002.
Senator Burr contributed important provisions in that bill.
We also worked together on the compensation program for persons
injured by smallpox vaccine, and his leadership will serve the
Senate and the country well in all aspects of this issue.
The Nation is obviously vulnerable to attacks with weapons
of mass destruction. Our focus today is developing new medical
initiatives in the fight to keep American families safe. We
must also recognize that even the best new treatments will do
little good if our emergency rooms are so overburdened that
doctors and nurses cannot deliver the effective care. The most
modern disease monitoring system will be of little use if
public health agencies are so starved for funds, they cannot
keep their community safe.
I want to just mention on the budget matter, we have seen
the proposed cut in funding from 2005 to 2006 in the CDC
program. We have the two aspects of the CDC program which are
well known and understood. First of all, you have to have the
detection, which the public health system does, and then you
have to have the treatment and the containment, which the
hospitals do. The cuts impact the CDC program that has been
working with the health agencies that do the detection and the
hospitals for the containment. And that is all part of this
whole effort to deal with the problems of bioterrorism. So this
is certainly something of very considerable concern to many of
us.
Study after study has shown that health agencies and
hospitals are making progress, but it is very slow, and they
have a long way to go. Despite the clear need for greater
Federal aid, the budget contains a 12 percent cutback in the
Federal programs that strengthen the health agencies, a major
cut in the program to strengthen our hospitals.
We took a significant step in Bioshield in the last
Congress to develop the cures of the future, but will slide
back if these proposed cuts are allowed to take effect. Our
committee has received many proposals to improve Bioshield
through additional incentives to industry. Incentives are an
indispensable part of defending against bioterrorism, but the
incentives have to be appropriate. We cannot afford to squander
resources on needless giveaways.
We are hearing today from a drug industry executive who is
doing the right thing, Gordon Cameron, who is the CEO of
Acambis to whom America owes a great debt of gratitude for what
Acambis did in producing 180 million doses of vaccine to keep
the Nation safe from smallpox.
I hope the administration will build on this success by
providing the funds needed to keep the production line for
smallpox active. What did it take to get Acambis to complete
this essential project? No wildcard patent extension, no extra
market exclusivity; it was just a contract under which Acambis
produced the vaccine on time and on budget. Obviously we need
to examine how Bioshield achieves its objectives, but we should
not run into overturning a balanced system of patent incentives
in the name of biodefense.
A similar issue arises in cases where some patients may be
harmed by the product itself. As part of the smallpox
vaccination effort, Congress granted appropriate indemnity for
the manufacture of the vaccine and the health professionals who
administer it. That indemnity was justified in the case of
smallpox since the vaccine could not be fully tested or meet
FDA standards at the time. Targeted indemnity protections make
sense, but that does not mean broad exemptions for negligence
just because the products have value for biodefense.
It is also important to have fair compensation for persons
injured by faulty products and proper safety protection for the
workers who administer them.
I look forward to the testimony of our witnesses that are
working with my colleagues to consider these issues and making
genuine improvements that might be needed in Bioshield. I thank
the chair very much.
Senator Burr. Thank you, Senator Kennedy. At this time the
chair would recognize the full committee chairman, Senator
Enzi.
The Chairman. Thank you, Mr. Chairman, and I would just ask
that my statement be made a part of the record as well as
anybody else who wants to make a statement to keep in the
tradition of having the chair and the ranking member do the
statements. I do appreciate all the expertise that you bring to
this and am so pleased that you are the chairman and are taking
this careful look at the impediments that are out there to the
current system. It was not perfect, but we got it done. The
next one will not be perfect either, but we will get it done,
and I appreciate the work you are going to do.
Senator Burr. I thank the chairman. Without objection, all
opening statements will be made a part of the record.
[The prepared statement of Senator Enzi follows:]
Prepared Statement of Senator Enzi
The threat of infectious disease spread by an epidemic or
bioterrorism is one of the greatest dangers currently facing us
as a Nation. As great a danger as it is, however, it is dwarfed
by our largely untapped ability to experiment, innovate, and
deliver the next generation of diagnostics, vaccines, and
therapeutics to address it.
That is why I greatly appreciate Chairman Burr's
willingness to hold this hearing and begin the work we must do
if we are to have an effective plan in place before it is
needed. I am looking forward to working with him, other members
and stakeholders in the months to come on this and many other
issues of concern that will have a great impact on our Nation's
safety and security for a long time to come.
Today's issue of Biodefense can't help but call to mind the
days so many of us spent as Boy Scouts. We all had Scoutmasters
who drilled into us the importance of the Boy Scout motto--Be
Prepared! Since September 11, that motto has never seemed more
relevant as we have been working to prepare ourselves and the
people of the United States for the potential threats that lie
before us--particularly the use of our own modern technologies
against us.
Fortunately, we have already begun to bring our resources
to bear on this challenge. Last year, in response to an act of
bioterrorism that was directed against this government, both
the Senate and the House worked together in a bipartisan
fashion to pass the President's Project Bioshield legislation.
I am proud to have been a cosponsor, although I was
disappointed that it took a year to complete the process. That
new law was a very important first step in the effort to
protect this country. We are continuing that journey with our
work today.
That legislation gave us a critical head start to meeting
the challenge posed by the threat of an outbreak of an
infectious disease. It established a permanent market for
vaccines and therapeutics that are directed to known and
foreseeable agents. It encouraged private industry to generate
therapeutics for bioterrorism agents that might be used today.
It did not attempt to address all of the impediments that block
private industry from more actively partnering to protect our
homeland from the threat of bioterror agents. It was a good
start that showed the way as we prepare to take the next step
in this important effort.
With an established mechanism in place to finance the
development of bioterror countermeasures, we must now make sure
that it is working and that the necessary resources are in
place to ensure the success of our efforts. That will require
the cooperation and assistance of an active and engaged
biotechnology and pharmaceutical industry, acting as our
partners in this effort. We have some of the greatest minds in
the country and in the world willing to work with us on what is
truly a global problem and a threat to us all, no matter where
we live. Using their creativity and expertise we can craft
solutions to this problem before they are needed. Clearly, that
will be the key to formulating an effective and reliable plan
of action on this issue.
We appreciate all the witnesses who are here with us today
to share with us their knowledge and insights on this
potentially devastating problem. They have come from across the
country and around the world to tell us what else is needed to
deliver therapeutics to health professionals. I appreciate
having Dr. Fauci and Dr. Albright with us to update us on the
results of our biodefense efforts. We do need their input and
involvement to help us coordinate the efforts of the public and
private sectors so that we will be able to rise to the
challenge and minimize the danger we face.
Again, I thank Chairman Burr for holding this hearing so
that we might have a better understanding of this threat and
what we must do to address it. I look forward to working with
this subcommittee, other members and stakeholders to take the
next steps that are needed to build a strong national
biodefense and ensure the safety of our people for generations
to come.
Senator Burr. At this time, since I see our first panel is
up, let me welcome both of you once again.
Senator Roberts. Mr. Chairman.
Senator Burr. The Senator from Kansas.
Senator Roberts. I am riding drag in this posse, and I
understand that, and that is my role and I am here for sort of
a parochial reason, being the chairman of the Intelligence
Committee and also a member of the Agriculture Committee and
the Armed Services Committee, but I do have a statement and
would ask permission that it be put in the record at this
point.
Senator Burr. Without objection, so ordered.
[The prepared statement of Senator Roberts follows:]
Prepared Statement of Senator Roberts
I am pleased that we are holding this hearing today to
discuss biodefense and the future. I thank the witnesses for
their willingness to share their thoughts on what steps need to
be taken to adequately prepare our Nation for the threat of a
bioterrorist attack. The events of September 11 forever changed
the world in which we live. We have all re-evaluated our
priorities and the measures of security which we take. We have
upped the level of security and surveillance for our government
buildings, sports venues, airports, defense facilities, and
economic markets. However, the threat of a bioterrorist attack
poses a unique challenge to our public health system. A
biological attack can unfold gradually over time, unlike a
chemical attack or an explosion where the results are
immediate. Therefore, our Nation must depend on the
preparedeness of our public health infrastructure to respond
quickly and appropriately to a bioterrorist attack.
In recent years, Congress has taken steps to alleviate the
threat of bioterrorism. Last July, President Bush signed
Project Bioshield into law. Project Bioshield is a step in the
right direction for protecting our Nation against bioterror
threats. It is no surprise that many potential bioterror agents
lack available countermeasures. Project Bioshield was designed
to encourage drug and biotech companies to work with the
National Institutes of Health (NIH) to develop antidotes,
vaccines, and other products to treat and protect against a
biological, chemical, radiological, or nuclear attack.
BioShield has three principal components: relaxes procedures
for bioterrorism-related procurement, hiring, and peer review;
guarantees a Federal Government market for new countermeasures
for inclusion in the Strategic National Stockpile (SNS); and
permits emergency use of unapproved countermeasures. While
these steps are positive, I do think there is still room for
improvement in areas such as vaccine liability, antitrust
issues, and tax reforms, and I am pleased this committee is
making Bioshield II a top priority.
When considering the next steps for our biodefense, I
believe our agriculture economy and sector should receive no
less attention. I believe that security for agriculture merits
serious concern by not only the agricultural community but our
Nation as a whole. The risk to the U.S. food supply and overall
economy is real. A close analysis of the agriculture markets
shows that the introduction of a pathogen such as foot-and-
mouth (FMD), avian flu, or Karnal Bunt in wheat could be
devastating. FMD is highly noxious and if properly placed in a
feedlot or hog confinement facility it could quickly reach
epidemic proportions.
In 2002, President Bush signed the Public Health Security
and Bioterrorism Preparedness and Response Act into law. The
measure is intended to bolster our ability to respond
effectively to bioterrorist threats and other public health
emergencies. Included in this important piece of legislation
are provisions to protect the Nation's food supply and enhance
agricultural security. Some of the most significant provisions
include:
Continuation of grants to top agriculture
universities and researchers across the Nation to develop
vaccines, antidotes and plant varieties that can resist such
diseases as Foot-and-Mouth Disease, Karnal Bunt or Avian Flu,
as well as other diseases that have been cultivated for use in
bio-warfare;
Provides the agriculture system with a new,
enhanced level of protection and biosecurity. This system for
first-responders utilizes or is capable of utilizing field test
devices capable of detecting biological threats to animals and
plants and then electronically integrates the devices and the
tests on a real-time basis into comprehensive surveillance,
incident management and emergency response system;
Expansion of the Food Safety Inspection Service
(FSIS) by enhancing the ability of the service to inspect and
ensure the safety and wholesomeness of meat and poultry
products at ports of entry.
In his 2006 budget released just yesterday, President Bush
recognized the importance of protecting our Nation's food
supply. His request includes a total of $596 million for the
Departments of Agriculture, Health and Human Services, and
Homeland Security to improve our ability to detect and contain
intentional and unintentional contamination of America's
agriculture and food system. This is a net increase of $144
million above 2005. President Bush is also requesting a $50
million increase for USDA's monitoring and surveillance
activities and a $78 million increase for research by USDA,
HHS, and DHS, including research into new detection methods.
While I realize the focus of this hearing is not on food
security, I do look forward to hearing from our witnesses on
their thoughts on how to protect and defend our Nation's food
supply. Thank you for your time.
Senator Burr. Let me once again welcome the two of you and
at this time recognize Dr. Fauci for his opening remarks.
STATEMENTS OF ANTHONY FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE
OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF
HEALTH, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES; AND
PENROSE C. ALBRIGHT, PH.D., ASSISTANT SECRETARY FOR SCIENCE AND
TECHNOLOGY, DEPARTMENT OF HOMELAND SECURITY
Dr. Fauci. Thank you very much, Mr. Chairman, Senator
Kennedy, Senator Enzi, Senator Roberts. Thank you for giving me
the opportunity to testify before this committee this morning
regarding the biodefense efforts, particularly at the NIH, and
how the research endeavor helps push us toward the development
of appropriate and necessary countermeasures.
Before I start describing that, let me briefly outline for
you within the Department of Health and Human Services the
multifaceted components that go into our biodefense efforts
including the Centers for Disease Control and Prevention that
was just mentioned by Senator Kennedy which is responsible for
surveillance and detection as well as training local response
teams.
The NIH conducts the basic and clinical research that lead
to the development of medical countermeasures. The FDA has an
important regulatory role and the Office of Public Health
Emergency Preparedness coordinates all of this. A few years
ago, the administration and the Congress gave us an enormous
responsibility at the NIH with a very dramatic increase in our
budget related to biodefense immediately following the
September 11, 2001 tragedy, as well as the anthrax attacks, and
this is reflected in the supplement for 2002, and then this
enormous increase in budget in 2003, which has been maintained
up through and including the current fiscal year and beyond.
This responsibility was taken very seriously by us at the
NIH because we knew we had to do the best science possible but
also we had a commitment to push for the development of
countermeasures. In order to fulfil this responsibility, we
immediately brought together blue ribbon panels of the experts
in the field of both infectious diseases, microbiology and host
defenses immunology and put together a strategic plan for our
biodefense efforts as well as two research agendas, one for the
Category A agents, the major threats that we will be discussing
this morning, as well as one for Category B and C, and I am
happy to report that we have already come out with two major
progress reports, one in August of 2003 and one in June of
2004, delineating not only the progress in real terms vis-a-vis
actual accomplishments but also how we are building the
infrastructure for the future years.
If one looks at the plan, it can be divided into a number
of components. First and foremost was the necessity to build
both the physical and the intellectual infrastructure necessary
to perform these tasks over the next few years, and I will
mention this briefly in a moment. When I say physical
infrastructure, I mean the containment facilities necessary to
do the research.
All of this is founded very strongly in basic research, and
this is a very important issue, because if we are going to do
it, we need to do it right, and good basic research at the
point of developing understanding of the pathogenesis of the
microbes will be not only important for developing
countermeasures in biodefense, but also will be extremely
important in extrapolating this to other health issues that
might have nothing at all to do with biodefense such as
naturally emerging and reemerging infectious diseases and some
cancer therapy or what have you.
This ultimately gets translated into the countermeasures as
we call them, namely, therapeutics, vaccines and diagnostics.
This is a map of the United States which delineates the
various components of the infrastructure that I am talking
about. This has rapidly been put in place. Some of these are
already being built. Others, the plans are in place and others
we are having planning for the future development of these.
First and foremost among these, we have the Regional
Centers of Excellence in Biodefense and Emerging Infectious
Diseases--those that are shown in the stars. This is the
intellectual capital that is distributed throughout the
country, generally associated with Regional Biosafety Labs, or
BSL3s, of which there are 9 throughout the country, and most
recently, the BSL4s, one in Boston and one in the University of
Texas at Galveston Medical Center.
We also have new facilities at the NIH, both on the campus
as well as in Fort Detrick and in our Rocky Mountain
laboratories in Missoula and Hamilton, Montana.
Getting back to the issue of basic research, I just want to
reiterate to you the importance of understanding, for example,
the sequencing of the microbes that might be associated with
bioterror. We successfully have sequences for virtually every
microbe that we consider to be a major threat. This is
extremely important when we target vaccines and therapies.
We have developed animal models, but we have also looked
at, and again, this gets to the extrapolation to other
diseases, host defense mechanisms such as the body's ability to
be able to fight against microbes including microbes of
bioterror, but also a natural extrapolation to emerging and
reemerging infections such as influenza, which we have a threat
now as you know of an H5N1 bird flu that we are considerably
concerned about.
Let me very briefly just summarize some of the key
achievements already. I came before some members of this
committee in other hearings regarding smallpox last year and
the year before. When we had the events in September of 2001,
we had about 15 million doses of smallpox for the 288 million
people in this country. We now successfully have over 300
million doses. We have doses for everyone in this country
including helping our allies if in fact they need it.
We are not stopping there because we are going to the next
generation of a safer smallpox vaccine, the modified vaccinia
Ankara, which again is being very rapidly accelerated by the
Bioshield that was just mentioned by you and by Senator
Kennedy. We are developing antiviral drugs such as an oral drug
against a microbe that was originally associated with HIV,
cytomegalovirus, and we find that it now has activity against
smallpox.
In the anthrax, I think this is the first--it is the
first--of the elements of the translation in real terms of
Bioshield that was just signed in July of 2004, and that was
the procurement of the recombinant protective antigen on the
Project Bioshield. We also have the development of novel
antitoxins and monoclonal antibodies. We also have a number of
other components such as Ebola, influenza and botulism toxin.
Now, Project Bioshield, as you know, is the component that
gives us authorities to accelerate. We have emergency approval
authority for the FDA, and we also have a set-aside amount of
money that we would use as incentive for purchase. The normal
paradigm at the NIH is to just do basic and preclinical
research and leave it to the companies because they have enough
incentive to develop a product.
We have now had to emphasize the push of that mechanism,
namely doing the basic research that pushes through early and
advanced development. Project Bioshield provides the pull or
the incentive for the companies to actually get involved in
signing the contacts that Senator Kennedy mentioned in order to
develop products.
We need to continue this partnership between industry and
academia and the Federal Government in having this push
mechanism meet the pull mechanism.
Finally, I just want to emphasize to you something that I
mentioned a few times during the discussion, and that is that
the investment in physical and intellectual capital that is
associated with our biodefense effort goes well beyond
preparing us for agents of bioterror. We look at the people we
are training; we look at the facilities that are going on; we
look at the products that are coming about. Each of these will
inevitably have important positive spinoffs particularly in
protecting us against naturally occurring infections such as
influenza, SARS and others, but also in other areas such as
cancer and other components of public health.
I would be happy to answer questions, Mr. Chairman. Thank
you for giving me the opportunity to testify.
Senator Burr. Thank you, Dr. Fauci.
[The prepared statement of Dr. Fauci follows:]
Prepared Statement of Anthony S. Fauci, M.D.
Mr. Chairman and members of the subcommittee, thank you for the
opportunity to speak with you today. I will discuss our national
biodefense research program, with particular emphasis on recent
progress toward the development of medical countermeasures against a
bioterrorist attack. I am particularly honored to appear at the very
first hearing of this subcommittee, and I look forward to working with
you to continue to improve our biodefense capabilities which are
essential to protecting our Nation's health.
The destruction of the World Trade Center, the attack on the
Pentagon and the downing of an airliner over Pennsylvania on September
11, 2001, clearly exposed the vulnerability of the United States to
brutal acts of terrorism. The anthrax attacks in Florida, New York and
Washington that followed only a few weeks later made it very clear that
the threat of bioterrorism with pathogens or biological toxins
represents a serious threat to our Nation and the world. The
Administration and Congress responded forcefully to this threat, and
biodefense has become a top national security priority for which
funding has increased substantially. The Department of Defense, the
Department of Health and Human Services (HHS), the Department of
Homeland Security (DHS), the Department of Agriculture (USDA) and other
Federal agencies each have been given important roles to play in
biodefense preparedness.
The National Institute of Allergy and Infectious Diseases (NIAID),
of which I am Director, is a component of the National Institutes of
Health (NIH) and the lead agency within HHS for the conduct of research
concerning potential agents of bioterrorism that directly affect human
health. Three other components of HHS also are charged with major
biodefense responsibilities. Among many roles, the Centers for Disease
Control and Prevention (CDC) carries out disease surveillance and
detection, maintains the Strategic National Stockpile of medicine and
medical supplies for use in an emergency, and trains and advises local
public health response teams. The Food and Drug Administration (FDA) is
responsible for regulatory approval of new biodefense countermeasures.
The Office of Public Health Emergency Preparedness (OPHEP) coordinates
all HHS biodefense activities. The President's fiscal year 2006 budget
proposal calls for $4.2 billion in funding for HHS bioterrorism
preparedness activities, an increase of $154 million over fiscal year
2005.
nih biodefense research
In the wake of the 2001 terrorist attacks, NIH embarked on a
systematic strategic planning process by convening the Blue Ribbon
Panel on Bioterrorism and Its Implications for Biomedical Research,
comprised of distinguished researchers representing academia, private
industry, civilian government agencies, and the military. Based on the
panel's advice and extensive discussions with other Federal agencies,
NIH developed three key documents to guide its biodefense research
program; these are the NIAID Strategic Plan for Biodefense Research,
the NIAID Research Agenda for Category A Agents (covering agents that
pose the gravest threat to human health, such as those that cause
smallpox, anthrax, botulism, and plague), and the NIAID Research Agenda
for Category B and C Agents (for agents whose biological properties
make them more difficult to deploy or less likely to cause widespread
harm than Category A agents).
The Strategic Plan provides a blueprint for the construction of
three essential pillars of the biodefense research program:
infrastructure needed to safely conduct research on dangerous
pathogens; basic research on microbes and host immune defenses, which
serves as the foundation for applied research; and targeted, milestone-
driven medical countermeasure development to create the vaccines,
therapeutics and diagnostics that we will need in the event of a
bioterror attack. The two Biodefense Research Agenda documents present
detailed descriptions of short-term, intermediate, and long-term goals
for research on the wide variety of potential bioterrorism threat
agents. NIH also conducts research into ways to mitigate harm to
civilians from chemical, nuclear, and radiological weapons. Meeting the
goals delineated in the research agendas required a significant
expansion of NIH programs already in place that study human pathogens
and the immune system. To implement the biodefense agendas, Congress
increased NIH appropriations for biodefense research from $53 million
in fiscal year 2001 to $1.5 billion in fiscal year 2003 and
approximately $1.7 billion in fiscal year 2005; the President has
requested $1.8 billion for fiscal year 2006.
The Nation's investment in a strengthened, accelerated and expanded
biodefense research program has already begun to return substantial
dividends in all three aspects of biodefense research outlined in the
Strategic Plan, which has been described in two recent progress
reports. Some of the funds are devoted to intramural research, which is
work carried out in NIH-owned and operated laboratories; most, however,
goes to extramural research funded through grants and contracts awarded
to researchers throughout the country at academic institutions and in
the private sector.
Infrastructure. Perhaps the most tangible signs of the increased
priority for biodefense research are the integrated research facilities
under construction to safely contain and study pathogens. In terms of
intramural facilities, construction is well under way for new
biodefense laboratories. NIAID also is supporting the construction of
National Biocontainment Laboratories (NBLs) which will include
facilities built to Biosafety Level 4 standards and will therefore be
capable of safely containing any pathogen. Nine Regional Biocontainment
Laboratories (RBLs), with Biosafety Level 3 facilities, also are
planned or already under construction. All of these high-level research
laboratories will provide the secure facilities needed to carry out the
Nation's expanded biodefense research program in a setting of safety
for both workers and the surrounding communities. NIAID also has funded
eight Regional Centers of Excellence for Biodefense and Emerging
Infectious Diseases Research (RCEs). This nationwide network of
multidisciplinary academic centers will conduct wide-ranging research
on infectious diseases that could be used in bioterrorism, and will
develop diagnostics, therapeutics and vaccines needed for biodefense.
These Centers will develop the human infrastructure that biodefense
research will require in the years ahead by serving as a training
ground for biodefense researchers, and the Centers will partner with
State and local public health agencies to help ensure a strong,
coordinated response in a time of crisis.
Basic Research. Advances in the field of medicine rest on a
foundation of basic research into the fundamental properties and
mechanisms of life. In biodefense, these studies include the sequencing
and understanding of microbial genes (genomics), how microbes cause
disease (pathogenesis), and how the human immune system and pathogens
interact (immunology). NIH-funded basic researchers have made
significant progress since 2001 in each of these areas. For example,
researchers have determined the genetic sequence of at least one strain
of every Category A, B, and C pathogen; in many instances multiple
strains have been sequenced, allowing researchers to better understand
the factors that determine virulence. NIH has established the Pathogen
Functional Genomics Resource Center to help researchers apply and
analyze the large new database of genome sequence information. In
pathogenesis, NIH researchers recently determined the three-dimensional
structure of anthrax toxin bound tightly to a target cell surface
receptor, and thus have gained a detailed snapshot of a crucial step in
the pathway that allows anthrax to kill. This work provides important
new leads for the development of novel antitoxins that could save lives
late in the disease when large amounts of toxin are present and
antibiotics alone are no longer sufficient to save the patient.
Finally, immunological studies of the human innate immune system, which
is comprised of broadly active ``first responder'' cells and other
mechanisms that are the first line of defense against infection, have
been moving forward rapidly. These advances suggest new ways to boost
innate immune responses and suggest that it will be possible to develop
fast-acting countermeasures that mitigate the effects of a broad
spectrum of bioterror pathogens or toxins. Manipulation of the innate
immune system also could lead to the development of powerful adjuvants
that can be used to increase the potency and effectiveness of vaccines.
Medical Countermeasure Development. The new emphasis placed on
biodefense as a national priority has led NIH to develop an expanded
paradigm with respect to biodefense product development. NIH has always
supported research that generates new knowledge about disease and has
worked to translate these findings into vaccines, therapeutics, and
diagnostics that protect public health. But to develop safe and
effective products for biodefense as quickly as possible, we needed to
intensify and accelerate this process. Thus, we have sought creative
ways to modify NIH's traditional process of research and development to
move ahead more rapidly while continuing to preserve the excellence in
basic research that is a hallmark of NIH. Working in close
collaboration with industry and academia, we have taken a much more
pro-active role in moving promising concepts into advanced product
development.
The Project BioShield Act of 2004 signed into law last July
provides powerful new mechanisms that will expedite the development and
deployment of medical countermeasures for bioterrorism. For example,
BioShield gives NIH additional flexibility in awarding contracts,
cooperative agreements, and grants for research and development for
critical medical countermeasures, and streamlines the scientific
evaluation of biodefense research proposals. The pharmaceutical
industry has proved to be willing and eager to help in the development
of biodefense countermeasures, but it needs a reasonable assurance that
a market for these products will in fact exist should industry invest
the resources necessary to fully develop them. To help provide these
incentives, BioShield establishes a secure 10-year funding source for
the purchase and stockpiling of new vaccines and drugs for use in an
emergency. To put it another way, BioShield has given us new ways to
both ``push'' and ``pull'' science toward needed countermeasures--basic
research provides the push, and new incentives to industry for product
development provide the pull. NIH works vigorously with both.
Much has been accomplished. With respect to medical countermeasures
against attack with biological agents, we are already in a far stronger
position today than we were only a few years ago. For example, in
September 2001 we had 15.4 million doses of smallpox vaccine available;
today we have more than 300 million doses. We also have a next-
generation safer smallpox vaccine called modified vaccinia Ankara (MVA)
in clinical testing and others under pre-clinical development. In
addition, a new oral form of an antiviral drug cidofovir is in advanced
product development for use in the event of a smallpox attack, as well
as to treat the rare but serious complications of the classic smallpox
vaccine. For anthrax, NIAID has aggressively pursued a new vaccine
called rPA; HHS has contracted with VaxGen, Inc. to purchase 75 million
doses of rPA under BioShield. This vaccine is produced using modern
vaccine manufacturing techniques and may require fewer doses than the
currently licensed vaccine. New anthrax therapies that can neutralize
the anthrax toxin are being developed, such as monoclonal and
polyclonal antibodies. Candidate antibody treatments for the toxin that
causes botulism are in development, as is a new vaccine to prevent the
disease. Finally, an Ebola vaccine based on a new strategy is in human
clinical trials at the NIAID Vaccine Research Center. I expect the
coming years to be at least as productive.
In addition, HHS is pursuing research, development and acquisition
of medical countermeasures to address radiological and nuclear threats.
These efforts include acquisition programs for a pediatric formulation
of potassium iodide under Project BioShield and acquisition of Prussian
blue by the Strategic National Stockpile. HHS is also seeking
information from industry about capabilities for developing medical
countermeasures to treat acute radiation syndrome and exposure to nerve
agents.
conclusion
I would close with one last point. Infectious diseases have
afflicted humanity since its inception, and they will always be with
us. The viruses, bacteria, and parasites that cause infectious diseases
do not remain static, but continually and dramatically change over time
as new pathogens emerge and as familiar ones re-emerge with new
properties or in unfamiliar settings. Emerging infections such as HIV,
Ebola and SARS and re-emerging infections such as plague and influenza
have shaped the course of human history while causing incalculable
misery and death. Fortunately, the knowledge and products that will
flow from the NIH biodefense research program, including research
results, intellectual capital, laboratory resources, and
countermeasures in the form of diagnostics, therapeutics, and vaccines,
will help us cope with naturally emerging, re-emerging, and
deliberately released microbes alike. Recent experience tells us that
knowledge developed to understand one pathogen invariably applies to
others. When HIV first emerged, for example, antiviral drug development
was in its infancy. Now, new technologies have led to the development
of more than 20 antiretroviral drugs that can effectively suppress HIV
replication and dramatically reduce AIDS morbidity and mortality. These
same technologies, and the lessons learned about antiviral drug
development, are being applied to the development of new generations of
drugs against many viruses, including influenza, SARS, smallpox, and
Ebola. Even if we are never confronted with another bioterror attack,
the biodefense research and preparations being carried out now will
without question prove to be very valuable.
HHS/NIH has a strong mandate from the President and Congress,
robust funding, and a detailed and vigorous plan to carry out needed
biodefense research. Our long institutional experience with infectious
disease research allowed us to seamlessly take on a greatly expanded
biodefense role when it became a priority, and I am confident that we
are making good progress. Again, Mr. Chairman, I look forward to
working with you and the members of the subcommittee to address the
challenges of bioterrorism preparedness and its impact on public
health.
I am pleased to answer any questions that you may have.
Senator Burr. The chair would recognize Mr. Albright.
Mr. Albright. Good morning, Chairman Burr, Senator Kennedy
and distinguished members of the subcommittee. I am pleased to
appear before you today to discuss the progress the Science and
Technology Directorate of the Department of Homeland Security
is making in the Nation's efforts to prevent, protect against,
respond to and recover from acts of bioterrorism against the
American people.
President Bush has made strengthening the Nation's defense
against biological weapons a critical national priority.
Although significant progress has been made to protect America,
President Bush instructed Federal departments and agencies to
review their efforts and find better ways to secure America
from bio attacks.
This review resulted in a joint Homeland Security
Presidential Directive, HSPD-10, joint along with the National
Security Presidential Directive, entitled ``Biodefense for the
21st Century,'' that provided a comprehensive framework for our
Nation's biodefense.
This directive builds upon past accomplishments, specific
roles and responsibilities and integrates the programs and
efforts of various communities--national security, medical,
public health, intelligence, diplomatic, agricultural and law
enforcement--into a sustained and focused effort against
biological weapons threats.
I would also be remiss in not pointing out that a similar
activity occurred with regard to the creation of a national
effort to protect our agricultural and food industries, and
that was embodied in Homeland Security Presidential Directive
HSPD-9, and under both HSPD-9 and HSPD-10, the Department of
Homeland Security has a role and responsibility in each of the
four pillars of the Nation's biodefense programs: threat
awareness, prevention and protection, surveillance and
detection, and response and recovery. And, in particular, the
Science and Technology Directorate has explicit
responsibilities in this integrated national effort.
I want to highlight the strategy, planning and
accomplishments to date of the Science and Technology
Directorate in the area of biodefense and the essential
collaborations with key Federal partners including those
represented here today.
Before I speak directly to the biodefense efforts of the
Science and the Technology Directorate, I want to mention the
role of the Department of Homeland Security's Information
Analysis and Infrastructure Protection Directorate, and
specifically I want to make clear that threat and vulnerability
assessments from IAIP are important inputs into the research,
development, test and evaluation activities of the Science and
Technology Directorate and are critical to the department's
decisions regarding the requisite material threat
determinations required in order to commit Bioshield funding.
In fiscal year 2004 and 2005, the Science and Technology
Directorate deployed the Biowatch Environmental Sensory System
to protect our Nation's cities from the threat and
ramifications of a bioterrorist attack. We are engaged in
creating additional near real-time monitoring. This is the
Autonomous Pathogen Detection System, and this is relevant to
the protection of critical infrastructure facilities such as
major transportation hubs. These were installed, for example,
in the Boston subway system during the Democratic National
Convention.
We initiated the design of a National Biosurveillance
Integration System as part of an interagency process working
very closely with Health and Human Services. We conducted
preliminary analyses of four baseline reference cases using a
reference scenario approach recommended by HSPD-10 for
understanding the requirements of an integrated national
biodefense architecture.
We established a Biodefense Knowledge Center, an
operational hub for enabling collaboration and communication
within the homeland security enterprise and we certified four
material threats which, of course, is relevant to the subject
of today's hearing, Bioshield.
We established the National Bioforensics Analysis Center to
provide a national capability for conducting forensic analysis
of evidence from biocrimes and terrorism to attain a biological
fingerprint in order to identify perpetrators and determine the
origin and method of attack.
In 2006, the department plans to complete the first formal
risk assessment that has been required under HSPD-10 and close
many of the key remaining experimental gaps in our knowledge of
classical biological threat agents. We will complete the
deployment of the next generation Biowatch system to the top
threat cities while continuing to operate and optimize the
already existing Biowatch systems.
We will complete test and evaluation of laboratory
prototypes for the third generation of the Biowatch detection
system for down select of fieldable prototypes in fiscal year
2007 and continue operation of the National Bioforensic
Analysis Center.
We will continue operation of the Plum Island Animal
Disease Center and perform essential upgrades to that facility
and we will initiate design of the National Bio and Agrodefense
Facility. And we will continue to develop bioassays for Foot-
and-Mouth disease and other look-alike animal diseases.
The NBACC, the National Biodefense Analysis and
Countermeasure Center, is a key component of the national
strategy for homeland security and addresses the need for
scientific research to better anticipate, prevent and mitigate
the consequences of biological attacks.
The NBACC's mission will support two pillars of the
blueprint laid out in HSPD-10: threat awareness and
surveillance and detection. NBACC is made up of two centers,
the Biological Threat Characterization Center and the National
Bioforensics Analysis Center I mentioned earlier, to carry out
these missions.
We also have a series of university centers that we have
established as part of this effort, so within the Science and
Technology Directorate, the Homeland Security Centers of
Excellence provide independent cutting-edge research within
academia for focused homeland security research and
development.
We have established centers, and they include a Homeland
Security Center for Risk and Economic Analysis, a National
Center for Foreign Animal Disease and Zoonotic Defense, and a
National Center for Food Protection and Defense. In the next
few months, the Science and Technology Directorate expects to
establish the Homeland Security Center for Behavioral and
Social Aspects of Terrorism and Counterterrorism.
Each center is selected on a competitive basis. Each center
has a role of addressing bioterrorism and two are specifically
aligned with addressing bioterrorism. Texas A&M University and
its partners from the University of Texas Medical Branch,
University of California at Davis, and the University of
Southern California expect to receive funds over the course of
the next 3 years for the study of foreign animal and zoonotic
diseases.
The center, which will be known as the National Center for
Foreign Animal and Zoonotic Disease Defense, will address
potential threats to animal agriculture including Foot-and-
Mouth disease, Rift Valley fever, avian influenza and
Brucellosis. The Foot-and-Mouth disease research will, of
course, be conducted in close collaboration with the
department's Plum Island Animal Disease Center.
The Department of Homeland Security expects to provide the
University of Minnesota and its partners, Michigan State
University, the University of Wisconsin at Madison, North
Dakota State University, Georgia Tech and the University of
Tennessee, with funds over the course of the next 3 years to
establish best practices and attract new researchers to manage
and respond to food contamination events both intentional and
naturally occurring. The National Center for Food Protection
and Defense will address agricultural security issues related
to postharvest food protection.
In addition, the Department of Homeland Security and the
Environmental Protection Agency are in the process of reviewing
proposals for a research Center of Excellence focused on an
area of high priority to both agencies, microbial risk
assessment for bio-threat agents.
The bio-threat agents of interest include bacteria, viruses
and biotoxins relating to anthrax, smallpox, botulinum,
botulism, plague, viral hemorrhagic fever and tularemia.
Now ensuring that all relevant Federal departments and
agencies coordinate in the area of biodefense is critical to
protecting the Nation from biological threats. The Science and
Technology Directorate has been and continues to be an active
participant in relevant interagency activities. A full list of
the interagency collaborations has been provided in my
statement for the record, and I will just highlight a couple.
As mentioned earlier, HSPD-10 laid out the overall
strategy, department and agency roles, as well as specific
objectives and calls for periodic reviews to plan, monitor and
revise the implementation of our biodefense enterprise.
This was followed by an interagency review that was
conducted under the aegis of the NSC and HSC specific to the
2006 to 2010 science and technology needs to support the
national biodefense strategy as articulated in HSPD-10.
This and other inputs from a variety of panels such as the
Counter Proliferation Technology Coordinating Committee and the
National Science and Technology Council's Weapons of Mass
Destruction Medical Countermeasures Committee help guide the
medical countermeasures procurement activities that are being
documented in the National Strategic Plan for Homeland Security
Science and Technology as required by the Homeland Security Act
of 2002.
The National Science and Technology's Council Weapons of
Mass Destruction and Medical Countermeasures Subcommittee, co-
chaired by myself, provides an interagency forum for discussing
and prioritizing medical countermeasure needs to be pursued
under Project Bioshield.
An interagency biosurveillance committee provides a forum
for coordinating and integrating the multiple activities in the
biosurveillance arena to provide an integrated bio-warning and
situational awareness system.
At the next level of coordination there are strong
bilateral efforts around key elements of the strategy. Examples
of this coordination include strong and frequent collaborations
on Bioshield between DHS and HHS, the development of
coordinated civilian and military surveillance and detection
systems between DHS and DOD, and the development of an
execution of a national strategy for agricultural biosecurity
and development and assessment of decontamination technologies,
the latter with EPA, the former with USDA.
So the science and technology programs conducted within the
Department of Homeland Security fully support the National
Biodefense Program as stated in the Presidential Directive
HSPD-10 and other homeland security presidential directives
such as HSPD-9. Moreover, they are conducted in active
collaboration with other Federal departments and agencies
having a role in meeting this national priority and are focused
on reducing the threat of a biological attack against the
Nation's population and its agricultural and food critical
agricultural infrastructures.
This concludes my prepared statement. With the committee's
permission, I would request my formal statement be submitted
for the record. Mr. Chairman, Senator Kennedy, and members of
the subcommittee, I thank you for the opportunity to testify
before you today.
Senator Burr. Thank you very much, both of you, and the
chair would ask unanimous consent that the full testimony of
all witnesses be included in the record. Without objection, so
ordered.
[The prepared statement of Mr. Albright follows:]
Prepared Statement of Penrose C. Albright, Ph.D.
introduction
Good afternoon, Chairman Burr, Senator Kennedy and distinguished
members of the subcommittee. I am pleased to appear before you today to
discuss the progress the Science and Technology Directorate of the
Department of Homeland Security is making in the Nation's efforts to
prevent, protect against, respond to, and recover from acts of
bioterrorism against the American people.
President Bush has made strengthening the Nation's defenses against
biological weapons a critical national priority. Although significant
progress has been made to protect America, President Bush instructed
Federal departments and agencies to review their efforts and find
better ways to secure America from bioattacks.
This review resulted in a Presidential Directive entitled
Biodefense for the 21st Century that provides a comprehensive framework
for our Nation's biodefense. This directive builds upon past
accomplishments, defines, specifies roles and responsibilities, and
integrates the programs and efforts of various communities: national
security, medical, public health, intelligence, diplomatic,
agricultural and law enforcement into a sustained and focused effort
against biological weapons threats.
The Department of Homeland Security (DHS) and the Science and
Technology (S&T) Directorate have explicit responsibilities in this
integrated national effort. In particular, I want to highlight the
strategy, planning and accomplishments to date of the Science and
Technology Directorate in the area of biodefense, and the essential
collaborations with key Federal partners, including those represented
here today.
biodefense
Before I speak directly to the biodefense efforts of the S&T
Directorate, I want to briefly address the role of the DHS's
Information Analysis and Infrastructure Protection Directorate (IAIP),
and how their work is linked to the S&T Directorate. IAIP assesses
intelligence and information about threats and vulnerabilities from
other agencies and takes preventative and protective action. They are
partners in the total interagency efforts to obtain, assess and
disseminate information regarding potential threats to America from
terrorist actions. These threat and vulnerability assessments are
inputs into the strategy and research, development, testing and
evaluation (RDT&E) activities of the Science and Technology
Directorate. For example, agriculture and food are two of the multiple
critical infrastructure sectors identified by Homeland Security
Presidential Directive 7. As such, they fall within the domain of the
IAIP Directorate; they are also within the domain of concern for
biological threats and are considered in HSPD-9 and HSPD-10/NSPD-33. In
addition, the IAIP Directorate's cooperation with the Science and
Technology Directorate is critical to the Department's mission to
determine what agents would significantly impact national security if
released (Material Threat Determinations).
mission and objectives
HSPD-10 outlines four essential pillars of the Nation's biodefense
program and provides specific directives to further strengthen the
significant gains made in the past 3 years. The four pillars of the
program are:
Threat Awareness, which includes biological weapons-
related intelligence, vulnerability assessments, and anticipation of
future threats. New initiatives will improve our ability to collect,
analyze, and disseminate intelligence on biological weapons and their
potential users.
Prevention and Protection, which includes interdiction and
critical infrastructure protection. New initiatives will improve our
ability to detect, interdict, and seize weapons technologies and
materials to disrupt the proliferation trade, and to pursue
proliferators through strengthened law enforcement cooperation.
Surveillance and Detection, which includes attack warning
and attribution. New initiatives will further strengthen the
biosurveillance capabilities being put in place in fiscal year 2005.
Response and Recovery, which includes response planning,
mass casualty care, risk communication, medical countermeasures, and
decontamination. New initiatives will strengthen our ability to provide
mass casualty care and to decontaminate the site of an attack.
The Department of Homeland Security has a role and responsibility
in each of these four pillars of the national biodefense program. The
S&T Directorate has the responsibility to lead the Department's RDT&E
activities to support the national biodefense objectives and the
Department's mission.
accomplishments and planned activities
In fiscal year 2004 and fiscal year 2005, the Biological
Countermeasures portfolio:
Deployed the BioWatch environmental sensor system to
protect our Nation's cities from the threat and ramifications of a
bioterrorist attack.
Engaged in creating additional near real-time monitoring
(Autonomous Pathogen Detection System) of critical infrastructure
facilities such as major transportation hubs. New infrastructure
protection efforts include shorter response time biological agent
detection capabilities for BioWatch. This pilot (second generation Bio
Watch) is in the process of being deployed in New York City and will
join an expansion of the number of collectors in that city.
Initiated the design of the National Biosurveillance
Integration System (NBIS) as part of an interagency process. Recently
completed in the first quarter of fiscal year 2005, we will work with
the Information Analysis and Infrastructure Protection (IAIP)
Directorate to implement this system.
Conducted preliminary analyses, using the reference
scenario approach recommended by Homeland Security Presidential
Directive (HSPD)-10 for understanding the requirements of an integrated
national biodefense architecture, of four baseline reference cases: a
large outdoor release of a non-contagious agent (anthrax); a large
indoor release of a contagious agent (smallpox); contamination of a
bulk food supply; and two highly virulent agricultural attacks, one on
livestock (Foot-and-Mouth Disease) and the other on crops (soy bean
rust).
Established the Biodefense Knowledge Center, an
operational hub for enabling collaboration and communication within the
homeland security complex. The Biodefense Knowledge Center will meet
the operational and planning requirements of government decision-makers
and program planners, the intelligence community, law enforcement
officers, public health practitioners, and scientists. Specific
capabilities offered to these end-users include knowledge services,
modeling and simulation, situational awareness and a pathway to
accelerate research and development.
Certified four ``material threats'' (anthrax, smallpox,
botulinum toxin, and radiological/nuclear); will complete the rest of
the Category A bioagents (plague, tularemia) by the end of fiscal year
2005.
Established the National Bioforensic Analysis Center
(NBFAC) to provide a national capability for conducting forensic
analyses of evidence from bio-crimes and terrorism to attain a
``biological fingerprint'' to identify perpetrators and determine the
origin and method of attack. The NBFAC was named in HSPD-10 as the lead
Federal facility to conduct and facilitate the technical forensic
analysis of materials recovered following a biological attack in
support of the appropriate lead Federal agency [in most cases the lead
Federal agency will be the Federal Bureau of Investigation (FBI)].
In fiscal year 2006, the Biological Countermeasure portfolio plans
to:
Complete the three high-level architectures initiated in
fiscal year 2005, identifying key requirements for each major element,
a ``report card'' on the current and projected status in that area and
performing detailed design tradeoffs for those areas in which DHS has
execution responsibility.
Complete the first formal risk assessment required under
HSPD-10 and close many of the key remaining experimental gaps in our
knowledge of the classical biological threat agents. Near-mid, and
long-term plans for dealing with engineered agents will be developed,
and R&D on addressing the gaps in responding to genetically modified
organisms (e.g., antibiotic resistant) initiated.
Complete the deployment of Generation 2 BioWatch systems
to additional cities while continuing to operate and optimize already
extant BioWatch systems.
Complete test and evaluation of laboratory prototypes of
the Generation 3 BioWatch detection systems for selection of fieldable
prototypes for fiscal year 2007.
Continue operation of the interim National Bioforensic
Analysis Center. International Organization for Standardization (ISO)
certification is expected to have been achieved, giving the analyses
conducted additional credibility and authenticity in both the national
and international community and courts of law. R&D will continue on the
physical and chemical signatures of the ``matrix'' materials associated
with biological agents so as to develop methods for understanding tell-
tale remnants of enrichment media, culture conditions, metabolites, and
dispersion technology.
Continue operation of the Plum Island Animal Disease
Center (PIADC) and essential upgrades to the facility and initiate
design of the National Bio and Agrodefense Facility (NBAF). R&D will
continue on next generation vaccines and antiviral therapeutics for
foot and mouth disease (FMD) and other high priority foreign animal
diseases.
Continue to develop bioassays for FMD and look-alike
animal diseases. The initial agricultural forensic capability
established in fiscal year 2004 at PIADC will be enhanced and
epidemiologic capability added. A High Throughput Diagnostics
Demonstration will be initiated to work with regional and State
laboratories to demonstrate a capability of analyzing thousands of
samples per day in support of response to a suspected case or an
outbreak. A FMD table top exercise will be conducted, and development
of a coupled epidemiological and economic model for FMD will begin. The
end-to-end systems study initiated in fiscal year 2004 for Soybean Rust
and FMD will be completed, and system studies will be initiated for
highly pathogenic avian influenza.
national bio-defense analysis and countermeasures center (nbacc)
The NBACC, a key component of the National Strategy for Homeland
Security, addresses the need for scientific research to better
anticipate, prevent, and mitigate the consequences of biological
attacks. The need for the NBACC facility is further defined in HSPD-10,
the Nation's blueprint for future biodefense programs. The NBACC's
mission will support two pillars of this blueprint--threat awareness
and surveillance and detection. The NBACC is made up of two centers,
the Biological Threat Characterization Center and the National
Bioforensic Analysis Center to carry out these missions. Specifically,
NBACC's mission is to:
Understand current and future biological threats, assess
vulnerabilities, and determine potential impacts to guide the research,
development, and acquisition of biodefense countermeasures such as
detectors, drugs, vaccines and decontamination technologies;
Provide a national capability for conducting forensic
analysis of evidence from bio-crimes and terrorism to attain a
``biological fingerprint'' to identify perpetrators and determine the
origin and method of attack.
In fiscal year 2004, the Department completed the planning and
conceptual design of the NBACC facility. Additionally, the Department
has been working through the National Environmental Policy Act (NEPA)
process during the year, which culminated in the signing of the Record
of Decision in January 2005 of the Final Environmental Impact Statement
(EIS) for the construction project and subsequent operations. It was
decided to delay the award of any contracts for design and construction
until further in the EIS process. As the public concerns are analyzed
and considered it is anticipated that contracts will be awarded in
fiscal year 2005 to initiate design and construction of the NBACC
facility.
In fiscal year 2005, the solicitations of contracts for the design
and construction of the NBACC facility are expected to be awarded. The
design of the NBACC facility will commence in March 2005. Congress
appropriated $35 million in obligated funds for award of the
construction contract in the fourth quarter of fiscal year 2005.
Construction of the facility is planned for completion by the fourth
quarter of fiscal year 2008.
university centers of excellence
The mission of the University Programs is to stimulate, coordinate,
leverage and utilize the unique intellectual capital in the academic
community to address current and future homeland security challenges,
and to educate and inspire the next generation of scientists and
engineers dedicated to homeland security.
Within the University Programs in the S&T Directorate, the Homeland
Security (HS) Centers of Excellence provide independent, cutting-edge
research in academia for focused areas of homeland security Research
and Development (R&D). Established centers include: the Homeland
Security Center for Risk and Economic Analysis of Terrorism Events, the
National Center for Foreign Animal Disease and Zoonotic Defense, and
the National Center for Food Protection and Defense. In the next few
months, the S&T Directorate expects to establish the Homeland Security
Center for Behavioral and Social Aspects of Terrorism and Counter-
Terrorism. Each Center is selected on a competitive basis, and each
grant is for 3 years. Each Center has a role in addressing bioterrorism
and two are specifically aligned with addressing bioterrorism.
DHS awarded funds, over 3 years, to the University of Southern
California (USC) and its major partners, University of Wisconsin at
Madison, New York University and Structured Decisions Corporation
(affiliated with MIT) to establish the Center on Risk and Economic
Analysis of Terrorism Events. The mission objectives are to evaluate
the risks, costs and consequences of terrorism and to guide
economically viable investments in countermeasures. Specifically, the
Center will develop risk assessment and economic modeling capabilities
that cut across general threats and targets, in application areas such
as electrical power, transportation and telecommunications.
Additionally, USC and their partners will develop tools for planning
responses to emergencies, to minimize the threat to human life and
reduce economic impacts of terrorist attacks.
Texas A&M University and its partners from the University of Texas
Medical Branch, University of California at Davis, and the University
of Southern California expect to receive funds over the course of the
next 3 years for the study of foreign animal and zoonotic diseases. The
Center, which will be known as the National Center for Foreign Animal
and Zoonotic Disease Defense, will work closely with partners in
academia, industry and government to address potential threats to
animal agriculture including Foot-and-Mouth Disease, Rift Valley fever,
Avian influenza and Brucellosis. The Foot-and-Mouth Disease research
will be conducted in close collaboration with DHS's Plum Island Animal
Disease Center.
The Department of Homeland Security expects to provide the
University of Minnesota and its partners, Michigan State University,
University of Wisconsin at Madison, North Dakota State University,
Georgia Institute of Technology, and the University of Tennessee at
Knoxville with funds over the course of the next 3 years to establish
best practices and attract new researchers to manage and respond to
food contamination events, both intentional and naturally occurring.
The University of Minnesota's National Center for Food Protection and
Defense, will address agricultural security issues related to post-
harvest food protection.
Negotiations began January 10, 2005, for a 3 year grant with the
University of Maryland for a fourth Center on Behavioral and Social
Research on Terrorism and Counter-Terrorism. We expect its mission
objectives to be to provide strategies for intervention of terrorists
and terrorist organizations and to embolden the resilience of U.S.
citizens. Major domestic partners include, the University of California
at Los Angeles, University of Colorado, Monterey Institute of
International Studies, University of Pennsylvania, and the University
of South Carolina.
A broad agency announcement was released in mid-January for
proposals for a fifth DHS Center of Excellence on the topic of High
Consequence Event Preparedness and Response.
In addition to the University Centers of Excellence, the Department
of Homeland Security's University Programs and the Environmental
Protection Agency's Science to Achieve Results (STAR) Program are
reviewing proposals for a research Center of Excellence focused on an
area of high priority to both Agencies, Microbial Risk Assessment (MRA)
for Category A bio-threat agents.
interagency collaboration
Ensuring that all relevant Federal Departments and agencies
coordinate in the area of Biodefense is critical to protecting the
Nation from biological threats. The previously mentioned HSPD-10, as
well as other directives including HSPD-9, Defense of United States
Agriculture and Food; HSPD-8, National Preparedness; HSPD-4, National
Strategy to Combat Weapons of Mass Destruction; and HSPD-7, Critical
Infrastructure Identification, Prioritization, and Protection, identify
national objectives and priorities, and departmental and agencies'
roles in addressing these national objectives.
The S&T Directorate has been, and continues to be an active
participant in these interagency activities as illustrated by our
participation in the biodefense program. At the highest level HSPD-10/
NSPD-33 laid out the overall strategy, department and agency roles, as
well as specific objectives and called for periodic reviews to plan,
monitor and revise implementation. This was followed by an interagency
review, of specific fiscal year 2006-fiscal year 2010 science and
technology needs to support the national biodefense strategy as
articulated in HSPD-10.
The National Science and Technology Council's Weapons of Mass
Destruction Medical Countermeasures Subcommittee (WMD-MCM), co-chaired
by the Assistant Secretary of the S&T Directorate, provides an
interagency forum for discussing and prioritizing medical
countermeasure needs to be pursued under BioShield. At still the next
level of coordination, there are strong bilateral efforts around key
elements of the strategy. Examples of this coordination including
strong and frequent collaborations on Bioshield (HHS/DHS), the
development of coordinated civilian and military surveillance and
detection systems (DHS/DOD), the development and execution of a
National Strategy for Agricultural Biosecurity (DHS/USDA), and
development and assessment of decontamination technologies (DHS/EPA).
In addressing these activities, DHS has a leadership role in
several key areas and partners with lead agencies in others. Those
areas in which the S&T Directorate provides significant leadership are:
Providing an overall end-to-end understanding of an
integrated biodefense strategy, so as to guide the Secretary and the
rest of the Department in its responsibility to coordinate the Nation's
efforts to deter, detect, and respond to biological acts of terrorism.
Providing scientific support to the intelligence community
and the IAIP Directorate in prioritizing the bio-threats.
Developing early warning and detection systems to permit
timely response to mitigate the consequence of a biological attack.
Conducting technical forensics to analyze and interpret
materials recovered from an attack to support attribution.
Operation of the Plum Island Animal Disease Center to
support both research and development (R&D) and operational response to
foreign animal diseases such as foot and mouth disease.
DHS also supports our partnering departments and agencies with
their leads in other key areas of an integrated biodefense: the
Department of Health and Human Services (HHS) on medical
countermeasures and mass casualty response; the U.S. Department of
Agriculture (USDA) on agriculture biosecurity; USDA and HHS on food
security and the Environmental Protection Agency (EPA) on
decontamination and on water security.
In addition, the Science and Technology Directorate has engaged
with other Federal Agencies in the following efforts:
The S&T Directorate worked with DOS (STAS), USDA, OSTP,
NSF to create and support the U.S.-Japan Safe and Secure Society forum.
The Directorate and DOS (OES) jointly created and
negotiated the U.S.-U.K. S&T Memorandum of Agreement (MOA). The
resulting MOA supports collaboration on Homeland Security research,
development, testing, and evaluation between the U.S. and the U.K.
Currently leads a partnership with CDC, EPA, and FBI on
the deployment of BioWatch, a bioaerosol detection system deployed to
many of this Nation's cities.
Funds BioNet--DTRA executed pilot program to integrate
civilian and military domestic biodetection and consequence management,
using San Diego as a pilot city.
Leading an interagency effort with HHS, DOD, and USPS to
develop a National Integrated Biomonitoring System, part of HSPD-10
responsibility.
Primary participant in the establishment of the National
Interagency Biodefense Campus being developed at Ft. Detrick.
The National Bioforensics Analysis Center (NBFAC) is a
joint Science and Technology Directorate-FBI program.
In a joint effort with USDA, have developed an integrated
national agrodefense strategy, with especial emphasis on foreign animal
disease. The Directorate and USDA also conduct joint research and
development programs at the Plum Island Animal Disease Center.
presidential initiatives
Three Presidential Initiatives address the needs of an integrated
biodefense strategy and DHS plays a key role in each one. These three
initiatives are:
BioShield: Signed into law July 21, 2004, BioShield is a program
coordinated by the Secretary for Homeland Security and the Secretary
for Health and Human Services that provides $5.6 billion over 10 years
for the purchase and development of countermeasures to WMD. DHS's S&T
Directorate plays a significant role in this in determining which
agents constitute ``material threats'' and in developing scenarios that
inform decisions on the quantity of countermeasures required. We have
certified four ``material threats'' (anthrax, smallpox, botulinum toxin
and radiological/nuclear and the rest of the Category A bioagents
should be completed by fiscal year 2006.
Biosurveillance Initiative: A program that seeks to enhance systems
that monitor the Nation's health (human, animal and plant) and its
environment (air, food, water) and to integrate these with intelligence
data to provide early detection of an attack and the situational
understanding needed to guide an effective response. The S&T
Directorate plays a major role in the Biosurveillance Initiative in
operating its 1st Generation BioWatch System, in deploying a 2nd
Generation system and significantly expanding the number of collectors
in the highest threat cities and at key facilities (e.g. transportation
systems), and in continuing to develop advanced detection systems to
further increase the capabilities. We are also designing the
information system that will be used to integrate health and
environmental monitoring information from the sector specific agencies
with intelligence data from the IAIP Directorate. Implementation of
this system will actually be initiated by the IAIP Directorate in
fiscal year 2005, but the S&T Directorate will continue to supply
subject matter expertise in biological threat and defense.
Food and Agricultural Initiative: Seeks to enhance the security of
our agricultural and food infrastructures. DHS activities in this area
are led by the IAIP Directorate--but the S&T Directorate brings
significant contributions in end-to-end studies of key agricultural and
food threats, through the development of advanced diagnostics, and
through R&D conducted jointly with USDA at the Plum Island Animal
Disease Center.
conclusion
The Science and Technology Directorate's programs conducted within
the Department of Homeland Security fully support the national
biodefense program as stated in the presidential directive Biodefense
for the 21st Century, and other Homeland Security Presidential
Directives. Moreover, they are conducted in an active collaboration
with other Federal departments and agencies having a role in meeting
this national priority, and are focused on reducing the threat of a
biological attack against this Nation's population and its agriculture
and food critical agricultural infrastructures, and supports a science-
based forensics and attribution capability.
This concludes my prepared statement. With the committee's
permission, I request my formal statement be submitted for the record.
Mr. Chairman, Senator Kennedy, and members of the subcommittee, I thank
you for the opportunity to appear before you and I will be happy to
answer any questions that you may have.
Senator Burr. The chair at this time would recognize the
full committee chairman for the purposes of questions.
Senator Enzi.
The Chairman. Thank you, Mr. Chairman. Dr. Fauci, in Dr.
Painter's and Dr. Epstein's written testimony, the NIH research
tool guidelines are identified as impediments to developing
anti-infective agents. Do you share the concern that these tool
guidelines are applied to research with anti-infective agents?
Dr. Fauci. I am not sure exactly what they are referring
to, Senator.
The Chairman. I think they are referring to the patenting
of the broadly applicable research tools such as cell lines and
animal models and things like that.
Dr. Fauci. The patenting components are impediments. This
is a very complicated issue, Mr. Chairman, because patents are,
as you know, very important incentives for companies and groups
to get involved in the development of the countermeasures that
we need. One of the problems with it is that when there is a
patent and the company is involved and has the patent but does
not pursue it, it makes it difficult for other companies to get
involved in that issue, if that is what they are referring to.
This is not an NIH issue. This is a Federal Technology
Transfer Act issue. So I am not exactly sure what the referral
is to an NIH impediment, but we tried to remove most
impediments to the kinds of goals that we are trying to set, so
I would be happy to discuss and debate that with the person at
a different time. Since he is not here, I cannot do that, or he
is here, but he is not at the table.
The Chairman. Sometimes the formats of the hearings make it
difficult to cover all the things.
Dr. Fauci. Yes.
The Chairman. But we will give you another opportunity
after we get more detail on how that works.
Dr. Fauci. Thank you.
The Chairman. In this hearing, we are trying to see what
some of the potential impediments are and what suggestions
there are for overcoming them, and then the committee will be
determining whether those are reasonable or not at a later
time.
In your written testimony--this will be a little more
fair--in your written testimony, you note the important
benefits that flow from biodefense research to research on
infectious diseases. Current law provides that if any product
has a substantial use for a bioterrorism application, a dual
use, then the provisions of Project Bioshield would generally
not apply.
So if a product for bioterrorism would also help say for
AIDS or malaria, Bioshield would not apply. Others have
suggested that dual use is a good thing. We want medicines for
all the infectious diseases, not just bioterror. So as a
medical doctor and the head of the infectious disease at NIH,
would you speak to the desirability of applying the Bioshield
provisions more broadly?
Dr. Fauci. In the original discussions of Bioshield,
Senator, I was and we were in favor of an extension beyond just
the agents themselves that are considered agents of bioterror.
As the legislation finally got to its form of being signed,
that did not get into the bill.
I think that is something for serious consideration. What I
was referring to that I believe is even more important in my
statement about the connection between what we do to develop
agents that are countermeasures against microbes of bioterror,
and how that impacts on others, is the actual fundamental
science that goes into it, the people you train, not
necessarily the end product, but the process that brings you up
to and including the development of a particular agent, be it a
vaccine or what have you, is going to keep us in very good
stead when we face a naturally emerging microbe.
We have already seen that with the SARS issue that we faced
a year and a half ago as well as what we are going through now
with our preparedness for pandemic flu, case in point, the H5N1
avian flu in Asia. So the training of individuals, the
infrastructure that was set up, the ability to deal with
microbes, sequence them, do the cloning, do the targeted
development of countermeasures, has been given a giant shot in
the arm by what we are doing with bioterrorism.
I was referring much more to that than to necessarily
having a product in the stockpile that goes beyond something
that is used as bioterror.
The Chairman. Thank you. Quick question for Dr. Albright.
In your testimony you mentioned that there are four material
threats. With regard to those threats, as for now, do we have
vaccines, diagnostics or therapeutics for each of those, or how
many and what do you think we will have in 12 months or 5
years?
Mr. Albright. The four material threats that we certified
as part of our responsibilities under Bioshield were smallpox,
anthrax, botulinum, and radiological and nuclear issues
threats.
For each of those we have certainly a certain amount of
arrows in our quiver. I mean obviously we have an extant
smallpox vaccine. We have treatment available for botulinum in
limited quantities. We have countermeasures for those people
who are exposed to radioactive debris, that sort of thing. I
think what this is intended to do is not just to promote new
capabilities--Dr. Fauci mentioned earlier the MVA smallpox
vaccine--that is certainly one of the motivators behind that
material threat determination--but also the need to procure
significant quantities of these materials.
For example, the amount of botulinum antitoxin that we have
in the stockpile or we have distributed, more importantly, to
hospitals is probably not sufficient in order to deal with a
mass attack or the kinds of attacks that we actually think
about.
So the point behind this is to be able to procure
sufficient quantities to, in fact, be better prepared for those
threats.
The Chairman. Thank you. My time has expired. I will submit
some written questions.
Senator Burr. Thank you, chairman.
Senator Kennedy.
Senator Kennedy. Thank you. Just to follow up with Senator
Enzi, which I think is an excellent point, I think it is useful
to have as explicit as possible how you can improve the process
and give guidance to the private sector in terms of these other
areas as well. I think I have heard that issue raised with some
companies, and I think it is useful just following up with what
my chairman has said.
I am going to try in a limited time to cover a number of
points. I am a strong believer, as Mr. Fauci knows and others--
that this is the time of the life sciences. The Congress has
understood it. We are seeing all kinds of possibilities out
there. I am a great believer in it.
There are enormous possibilities as well in this whole area
of biodefense, but we have seen this dramatic reduction in
terms of research, a significant reduction if you factor in the
cost of living. We have 3.2 percent inflator, and we are
getting .4 percent in terms of inflater. So that is going to
affect what you are doing in the research area at the NIH.
If you look over the graph here in terms of the preventive
health service and the health service grants, they were $132
million, 2004; $131 million, 2005; zero in 2006. These
preventative health service block grants, go to local
communities, help local communities in terms of detection and
planning, zeroed out--zeroed out.
You talk about the various facilities. We have the chart
about your various facilities that you had up there. You have
gone from 260 to 270 down to 30. I do not know how you are
going to complete your P4, whether it is in Texas or up in
Boston, with those kinds of figures. You are going down to $30
million when the costs are up there in Boston are $140 million,
$130 million to complete that facility.
So I do not know what these--the presentation is enormously
impressive, and I have enormous respect for both of you and
money is not everything. But if we are talking about national
security, and we are talking about homeland security, and we
are talking about biodefense industry, you cannot do it on the
cheap on this. And this is a matter, I think, of real concern
when we see the cuts in areas which have been-targeted in terms
of the homeland security.
Let me ask you, Dr. Fauci, there was concern up in my city
of Boston about the biosafety of that lab Level 4. I think you
are familiar with the tularemia problem that we have up there
and the issues in terms of safety for the Level 4 category is a
concern. Safety has always been the number one issue in terms
of both the NIH, in terms of the development of the P3 and the
P4 facilities. I know that. I know it is for the mayor. I know
it is for Boston University.
Could you just very, very briefly indicate to us the kinds
of safety and security that you all insist on in terms of
moving ahead? Give some assurance to the people in these local
communities that safety is first and foremost on your agenda. I
have limited time so I am going to try and get one more area.
Dr. Fauci. It is a very relevant question, Senator, and it
is really quite safe. I will forward to your staff
electronically a list of at least 9 or 10 of the issues, but
let me just mention 1 or 2 of them because we are constrained
on time.
First of all, there are extraordinary precautions about
limited access, things that go so far as thumbprints, retinal
scans, special IDs. The BSL4 that is being built at BU has the
classic CDC-government approved specifications such as
filtering of all air that goes in and out, double door access,
interlocked, so that both cannot be opened. All liquids that go
in there are drained into what we call a cook tank where it is
subjected to high temperatures before it is released.
All solid waste is autoclaved. Safety cabinets, personnel
precautions such as showers and showering down of clothing,
disposal of clothing. It is extraordinarily safe. We take the
concerns of the community very seriously, but I can say that it
is quite safe. There has not historically in this country been
a single incident of a harmful event with a community person
associated with a BSL4 facility.
Senator Kennedy. OK. Just two final areas. One is the
coordination between NIH, the DHS and DOD on research, if you
could comment? There has been some concern about that. Then,
finally, just on your new facility that you are building out at
NIH, the vaccine facility, what is the capability of that? I
mean how could it respond to a crisis, if you could just make
brief comments.
Dr. Fauci. Yes.
Senator Kennedy. Thank you, Mr. Chairman.
Dr. Fauci. Will do, Senator. First of all, with regard to
how we coordinate between DOD, DHS, we have a coordinating
capability that really emanates out of the Office of Homeland
Security and the Homeland Security Council at the White House
which we all meet frequently, myself and Parney, and others. We
exchange information. We exchange our plans, our strategic
plans, so there is quite a good degree of coordination that
comes actually straight from the Homeland Security Council.
With regard to your question about the building on the NIH
campus, that is going to be a BSL3, not a BSL4. It will serve
to consolidate the individuals at NIH who are involved in
research on biodefense and emerging infectious diseases. So it
will be an increased physical capability, but also putting
people in one place so that you can have an intellectual
exchange that is necessary to get the best out of the science.
Senator Kennedy. Thank you, Mr. Chairman.
Senator Burr. Thank you, Senator. Senator Roberts.
Senator Roberts. Thank you very much, Mr. Chairman. At this
point, I would like to submit for the record a summary of the
President's Budget as it applies to Homeland Security. I would
note that there is a 3.2 percent increase in bioresponse
spending in NIH, a .5 increase in regards to NIH overall. I do
this only to add in a matrix and agree with the concerns by
Senator Kennedy, but I think it is important that we have the
total budget figures in here. So I would ask that that be
inserted at this point.
Senator Burr. Is there objection? So entered.
[The material presented by Senator Roberts follows:]
Homeland Security
The President's 2006 Budget will continue to ensure the security of
the Nation's borders, ports, and transportation systems with enhanced
screening of goods and people through programs such as the new
Screening Coordination and Operations Office; an increase for the
United States Visitor and Immigrant Status Indicator Technology (US-
VISIT) system; additional radiological and nuclear inspection
equipment; and expansion of the Container Security Initiative. The
President's 2006 Budget will also enhance enforcement, border, and port
security with increases to the Border Patrol; continued execution of
the Arizona Border Control Initiative (ABCI); improvements to the Coast
Guard; and new, threat-focused State and local assistance grants.
fiscal year 2006 budget highlights
An 8 percent increase in government-wide, non-defense
homeland security spending, including fee-funded activities, over 2005.
An overall increase of $555 million for the Federal Bureau
of Investigation, which is 11 percent above 2005 levels, and a 76
percent increase since 2001. Homeland security funding for FBI
increases 21 percent in the 2006 Budget, from $1.736 billion in 2005 to
$2.099 billion in 2006.
$3.6 billion for State and local first-responder grants
and other assistance. The 2006 Budget proposes to restructure $2.6
billion of this funding so that the Department of Homeland Security
(DHS) can target grants for States, urban areas, and infrastructure to
fill critical gaps in State and local terrorism prevention and
preparedness capabilities, taking into consideration their threats,
vulnerabilities, and needs.
$50 million to fund Citizen Corps, which brings together
local leaders, citizen volunteers, and a network of first-responder
organizations in local preparation and response efforts.
protecting critical infrastructure
$873 million for DHS' Information Analysis and
Infrastructure Protection Directorate, which coordinates the Federal
Government's efforts to protect the Nation's critical infrastructure,
including commercial assets (e.g., stock exchanges), government
facilities, dams, nuclear power plants, national monuments and icons,
chemical plants, bridges, and tunnels;
$600 million for the Targeted Infrastructure Protection
Program to assist State and local governments in reducing the
vulnerability of critical infrastructure, such as chemical facilities,
ports, and transit systems.
$44 million for the Environmental Protection Agency (EPA
to fund its Water Sentinel Initiative to help protect the Nation's
water supply. Water Sentinel will utilize current technology and
develop new technology to produce an operational water monitoring and
surveillance system for threat contaminants.
In total, the President's Budget for 2006 requests $185
million for EPA's homeland security activities, a 73 percent increase
over 2005. This includes:
$19 million in new funds to develop the necessary
capabilities for detection and decontamination of threat agents. This
investment in decontamination will strengthen the Federal Government
through strengthening near-term capabilities and developing improved
methods for the future. Additionally, $12 million is dedicated to
meeting EPA's responsibility to establish environmental lab support
capacity.
The Budget also maintains resources of $106 million to
continue support for investigation and training activities, technical
assistance to States, cooperative research, and EPA's national response
teams.
defending america's borders, coastlines, and ports of entry
$6.9 billion for the Coast Guard, an 11.4 percent increase
over the comparable 2005 level. This includes:
$1.9 billion for the Coast Guard's Port, Waterways,
and Coastal Security mission, to fund a variety of high-priority Coast
Guard initiatives like armed, high-speed boats in ports with liquefied
natural gas terminals, further implementation of the Automatic
Identification System to track sea-going vessels and enhance Maritime
Domain Awareness, new weapons systems for the Coast Guard's helicopter
fleet, and implementation of the Common Operating Picture to enable
Coast Guard assets to work better together.
$966 million for the Coast Guard's Deepwater
acquisition project, which will fully recapitalize the agency's fleet
of major ships and aircraft, while simultaneously implementing a
sophisticated new Command, Control, Communications, Computers,
Intelligence, Surveillance, and Reconnaissance (C4ISR) system. This is
an increase of 33 percent over 2005 levels.
$37 million for 210 additional Border Patrol agents,
$20 million to continue improving the sensor, communication, and video
surveillance capabilities along our borders, and $20 million for the
acquisition and replacement of aging Border Patrol aircraft.
An increase of $176 million for the detention and removal
of illegal aliens, including:
$90 million for increased detention beds and
additional detention and removal officers;
$39 million for the detention and repatriation costs
of the ABC I, which aims to deter illegal crossings of the desert;
$8 million to apprehend alien fugitives and $5.4
million to ensure that aliens convicted of crimes in the United States
are deported directly from correctional institutions after their time
is served, preventing their release into the community;
$3.5 million for additional attorneys to prosecute
immigration cases;
$5.4 million to expand custody arrangements for non-
criminal aliens, particularly asylum seekers, to help ensure their
appearance at immigration proceedings.
A $5.4-million increase for the Container Security
Initiative, which pre-screens cargo before it reaches America's shores.
$178 million in DHS for improved radiological and nuclear
screening equipment at our borders.
An $8.2-million increase for the Customs Trade Partnership
Against Terrorism (C-TPAT) to support partnerships with some of the
biggest American importers to improve cargo security.
A $50-million increase for accelerated deployment of US-
VISIT at land border ports of entry and for enhanced access for border
personnel to immigration, criminal, and terrorist information. With the
2006 Budget, spending on US-VISIT will total over $1.4 billion through
2006.
improving aviation security
More than $4.5 billion for TSA aviation-screening
operations, a $400-million increase over 2005. Funding will ensure
sufficient resources for 45,000 Federal screeners and 10,000 screening
devices nationwide;
A $26-million increase for the Federal Air Marshals
program to protect our Nation's airplanes and passengers;
$110 million to test technical countermeasures against
shoulder-fired missiles for safety and reliability.
safeguarding against nuclear, biological, and chemical threats
To focus domestic efforts to combat nuclear terrorism, the
Department of Homeland Security will stand up the Domestic Nuclear
Detection Office (DNDO). DNDO's primary mission will be to strengthen
the deployment of the nuclear detectors at home while working to
improve the quality of those detectors over time. The office will
integrate domestic nuclear detection efforts undertaken by Federal
agencies, governments at the State and local level and the private
sector, and will be closely linked with international efforts. DNDO
will focus and streamline Federal capabilities in areas such as:
Research: DNDO will oversee a coordinated approach to
radiological and nuclear research efforts at DHS, the Department of
Health and Human Services (HHS), and the Department of Energy. The
Budget provides $262 million, more than twice the amount in 2005, for
DHS research and development of advanced-detection devices to minimize
the likelihood of a radiological or nuclear device entering the United
States.
Border Monitoring: DNDO will work to ensure optimal
deployment of radiological and nuclear screening equipment.
Grants: DNDO will work with State and local
governments on allocating their grants towards the most effective
detection equipment and technology.
$4.2 billion for HHS, a $154 million increase, to
address the threat of bioterrorism;
$107 million, double the funding level in 2005, for
DHS research and development into chemical agent countermeasures.
protecting the nation's agriculture and food system
The 2006 budgets for the Departments of Agriculture
(USDA), HHS, and DHS include a total of $596 million to improve our
ability to detect and contain intentional and unintentional
contamination of America's agriculture and food system, a net increase
of $144 million above the 2005 enacted level.
$63 million is provided for an interconnected food lab
network to increase the size of the network from 21 to 60 labs and
improve the rapid exchange of data.
Early detection of potential threats will be improved
through a $50 million increase for USDA's monitoring and surveillance
activities and a $78 million increase for research by USDA, HHS, and
DHS, including research into new detection methods.
The Budget includes $59 million to complete construction
of USDA's state-of-the-art animal disease research and diagnostic
facility located at Ames, Iowa, which will also support the National
Animal Health Laboratory Network.
cyber security
The 2006 Budget provides $94 million in funding to the
National Science Foundation for research related to cyber security,
which is critical to staying ahead of threats to IT infrastructure.
The Budget also provides $73 million for the National
Cyber Security Division within DHS to monitor, respond to, and notify
the general public of cyber threats.
The Budget also provides $10 million in funding for the
Cybercorps program, which funds grants for graduate and undergraduate
education in cyber security that will strengthen the future of the IT
security workforce.
promoting national health security
The 2006 Budget provides an additional $153 million for
the Strategic National Stockpile to improve the Nation's ability to
respond to biological and chemical weapons attacks with life-saving
treatments and supplies, including additional antibiotics to treat
anthrax, nerve agent treatments, and chemical countermeasures through
the Chempack program.
The Budget for the Stockpile also includes increased
funding for the storage and maintenance of next-generation
contermeasures, including a new anthrax vaccine purchased through the
President's newly enacted Project BioShield.
Within the 2006 Budget's nearly $29 billion for the
National Institutes of Health, the Administration will continue to fund
biodefense research and development activities at $1.8 billion. This
includes $50 million for chemical countermeasure development and $47
million for radiological and nuclear countermeasure development.
The Budget proposes nearly $1.3 billion in investments to
bolster hospital preparedness and State and local biodefense
preparedness. Included in the total for hospital preparedness is $25
million for a targeted, competitive demonstration program to establish
a state-of-the-art emergency-care capability in one or more
metropolitan areas.
The Budget also includes $70 million to improve the
emergency health care response to a mass casualty event by allowing the
Federal Government to purchase and store deployable medical care units,
including medical supplies and equipment that can be delivered to an
affected area. This funding will also help ensure the availability of
health-care providers in response to an emergency.
national biosurveillance initiative
Last year, the President proposed a new biosurveillance
initiative to provide earlier indication that an attack has occurred,
and to more accurately determine its nature and scope by monitoring
human, animal, and plant health, the food supply, and the environment.
The 2006 Budget will build on this progress with a $218-million
investment in the gathering and analysis of this information.
Senator Roberts. I know that this hearing is not on food
security, although it has been mentioned by Dr. Albright, and I
thank you, sir, for your perseverance. I thank you both for
your leadership and taking the time to come here. I am pleased
that with all of the things in the budget that we worry about--
and those of us in agriculture do worry about some of the cuts
that have been proposed--the President has included a total of
$596 million for the Department of Agriculture, Health and
Human Services and also Homeland Security to improve our
ability to detect and contain intentional and unintentional
contamination of America's agriculture and food system--that is
a net increase of $144 million over last year--$50 million
increase for USDA's monitoring and surveillance activity, $78
million increase for research by the USDA.
Now this is on purpose. Last year, the White House issued
the Homeland Security Presidential Directive. Everything has to
be an acronym in Washington. So that is HSPD-9, and it deals
with the coordination of food and agriculture security. I know
there have been some other concerns and primary concerns on the
part of the subcommittee.
But this means that the DHS should be the lead agency in
this process, and I am aware of the many steps that the
Department of Agriculture has taken in this area, so the
questions I would have for you, Dr. Albright, and I will just
submit them for the record, because we are on a very limited
time schedule here, can you tell me what the Department of
Homeland Security is doing to really coordinate these efforts?
Specifically, how are you working with the Department of
Agriculture, Food and Drug Administration, Health and Human
Services, and Defense, and intelligence agencies, and I
emphasize that because when I ask everybody--and we have an
``oh-my-God-hearing'' every week--and as chairman of the
Intelligence Committee, I said what keeps you up at night?
One of the things, one of the top threats that we have is
in regards to our Nation's food supply. The former department
head, when he left, Tommy Thompson, and, you know, rode off
into the sunset back to Wisconsin or wherever Tommy is, he said
that basically our food supply was not safe, and that raised
hell all up and down the ag press, and they came to me and they
came to Saxby Chambis, and they came to me as chairman of the
Intel committee, and said is that right? How are your efforts
really coordinated with the National Security Council? And then
basically the President's Homeland Security Council? How many
DHS staff, HSC staff and other agency staff are working on this
issue? How often does the department meet with other agencies
to really try to coordinate these efforts?
I notice on your chart, you have CDC, you have NIH and FDA.
You do not have USDA. And you do not have the intelligence
folks. Now I know that they are included in this, but I asked--
and I have gone over to the DHS and these analysts are very
young now and they are loaned from other agencies, and I know
that the new head of the agency that has just been approved
will do what they can--I found one person, one person, that has
an aggie background that is worried about agro-terrorism
although we call it food security. We do not call it agro-
terrorism anymore because it scares people.
Then, in addition, we have the Assistant Secretary, Jim
Moseley, who is in Afghanistan, I think, as I speak, for about
the fourth time trying to get ahold of Foot-and-Mouth disease
and other diseases that could be imported by the Taliban over
here to this country. The Department of Agriculture has
conducted several war games. Now this is why I am so worried.
At one time about 2 or 3 years ago, we had a war game and it
was called Crimson Sky, and it was an attack in regards to
Foot-and-Mouth disease from Iraq, but it could be from any
country, and I served as president. The reason was that Senator
Kennedy was out of town. He had important business.
[Laughter.]
And so consequently, what happened to us is that we had an
attack by Iraq. There were six States involved. It is a very
easy process. You just put a handkerchief underneath the nose
of an infected animal over in Afghanistan. You put it in a
ziplock bag. You send it to the United States. You drop it in a
feedlot, hopefully not in Kansas, also Wyoming, also North
Carolina.
[Laughter.]
You can drop it in Massachusetts if you want to.
[Laughter.]
And so I was president. In 6 days, there is the infestation
period and then all hell broke lose. And by ``break loose,''
here is what happened. Number 1, our markets collapsed. Number
2, all of our exports stopped. All agricultural export products
stopped.
Number 3, everybody in this room and all throughout America
realized that their food supply does not come from grocery
stores; by golly, it comes from the farm. So they panicked. At
every grocery store in America, there was a panic, and so we
had really economic chaos. I ordered a livestock stop-order
because governors were marshaling their National Guard--when we
had National Guard in our States--okay--and so Oklahoma was
putting up National Guard in between Texas, which is a natural
thing from time to time
[Laughter.]
But, at any rate, no livestock movement.
So I stopped livestock movement and the Department of
Commerce said, sir, you cannot do that, and I fired him. That
felt very good as president.
[Laughter.]
Then we had to terminate, we had to terminate thousands and
thousands and thousands, hundreds and thousands of critters,
trying to figure out how on earth to do that. So we called out
the National Guard, active duty force, and you had to do it by
shooting them. You do not do it by burning them. That is
exactly what happened with Great Britain. That is the wrong
thing that you had to do.
We had to dig a ditch in Kansas 29 miles long, the size of
a football field wide, so it would not leach into the
groundwater and we ran out of ammunition, and then we had PETA
there to demonstrate.
[Laughter.]
Then we also had TV and it was one hell of a mess, and we
lost strains of cattle and the Nation's food supply was harmed
for 1, 2, 3 years.
So you can see why I am a little concerned in regards to
what is going to happen in regards to agro-terrorism or food
security, and I am concerned there is only one person over
there at the Department of Homeland Security, and during the
Terrorist Threat Information Center briefing they have every
week, I know this comes up, and I urge you with all the
questions that I have asked, and I have not even given you a
chance to respond, please come back and tell me that we are
much better coordinated and we are in much better shape. We are
in better shape, by the way, I can tell you that, in terms of
our Nation's food supply.
That is why I am here, and I think as I look, one of the
egregious things that you did, Mr. Chairman, is that you did
not put a time limit thing in front of my name.
[Laughter.]
But I can see it over there by Senator Kennedy and also by
Senator Murray.
[Laughter.]
So I will cease and desist if you can answer those
questions. Thank you for highlighting that. I think it is one
hell of a problem.
Mr. Albright. Well--
[Laughter.]
Senator Roberts. Why don't you just say you agree and we
can get on with it.
[Laughter.]
Mr. Albright [continuing]. Yes, sir. I agree, sir. And I
look forward to answering your questions. I think we can answer
most of those, probably not all of them, and actually what I
would like to do is I would be more than happy to bring our
people that work agricultural issues to come up and brief your
staff at their convenience.
Senator Roberts. Why don't we have a briefing to my staff
which I can share with all of the people here and then we will
not take up their valuable time for questions. Senator Reed and
Senator Murray are waiting not so patiently.
Mr. Albright. Will do.
Senator Roberts. OK. Thank you.
[Questions of Senator Roberts follow:]
Questions of Senator Roberts to Penrose C. Albright, Ph.D.
Question 1. Last year the White House issued Homeland Security
Presidential Directive HSPD-9, dealing with the coordination of food
and agriculture security. HSPD-9 indicates that DHS should be the lead
agency in this process. I am aware of many of the steps USDA has taken
in this area both prior to and after this announcement. Can you tell me
what DHS is doing to coordinate these efforts? Specifically, how are
you working with USDA, FDA, HHS, and the defense and intelligence
agencies on this front? How are your efforts coordinated with the
National Security Council and the president's Homeland Security
Council? How many DHS staff, HSC staff, and other agency staff are
working on this issue? How often does the department meet with other
agencies to coordinate these efforts?
Question 2. The Department of Agriculture has conducted several
``war game'' scenarios related to agriculture and food security. I
participated in one of these known as ``Crimson Sky.'' It dealt with
the impact of an intentional introduction of foot-and-mouth disease
into the United States. It revealed the truly astounding impact this
could have on not just agriculture but the overall economy. Many State
governments have also looked at this issue, and USDA has worked to set
up rapid diagnostic networks for both plant and animal diseases. Are
you aware of the outcomes of this, and similar, activities conducted by
USDA. What role would DHS play in such an outbreak, if it were ever to
occur? Have you discussed your response plans, if any with other
Federal agencies and State governments?
questions of senator roberts to the panel
Question 3. We have heard much regarding vaccine disease research
for potential bioagent threats. This is important research. I'm
interested in whether or not you have conducted, or looked into
conducting, similar research on vaccines for animal diseases that could
be used as bioagents. In addition, how important do you believe such
research should be, in light of recent diseaeses such as SARS and avian
influenza, that also have the potential to dramatically impact human
health?
Question 4. We currently have in place rapid response teams
throughout the Nation that could quickly deploy to address acts of
terrorism. Are you doing any work to develop similar teams to deal with
agriculture and food security issues, and/or are the current teams
trained in these areas as well?
Senator Burr. Thank you, Senator Roberts, and I will not
make the same mistake twice. I will get a little time thing
right in front of you.
[Laughter.]
We are significantly advantaged by having your knowledge of
agriculture and your experience on intelligence and let me
assure you that the man to my right has assured me that we will
not leave agriculture out of our review from the standpoint of
this committee.
Senator Murray.
Senator Murray. Senator Reed was here ahead of me.
Senator Burr. Senator Reed.
Senator Reed. Thank you very much, Mr. Chairman. I am still
trying to process the questions. So forgive me. Senator Roberts
even looks a little like Johnny Carson from this vantage point.
[Laughter.]
Senator Roberts. He is dead, Jack, for God's sake.
[Laughter.]
Senator Reed. And I sound like Ed McMahon.
[Laughter.]
Senator Roberts. Now, Jack, cut that out.
[Laughter.]
Senator Reed. We do this all the time. Thank you, Senator.
Dr. Fauci and Dr. Albright, thanks so much for your testimony
and for your service. You mentioned that you have spent months
devising a strategy to respond to these threats to the United
States, and I am curious about the strategy in terms of how it
relates to the need for both public and private participation
in the process. You talked about building infrastructure. It
seems to me that a lot of this investment involves direct
Federal expenditures. We will eventually have legislation
before us that talks about granting patent waivers and
extensions, et cetera.
I frankly do not think we in Congress are working off the
same strategy, or at least appreciation of the strategy your
agency has developed.
Can you give us an evaluation of what authority you need in
terms of incentives to private industry vis-a-vis government
programs? One final point--it seems to me that we are buying
products that have very little commercial applicability.
Unfortunately, this is not something where we can dovetail on
an industry that with a little help will do things because they
see a commercial benefit. I would appreciate both your
comments, gentlemen.
Dr. Fauci. You are quite correct, Senator Reed. There is an
issue with regard to an incentive to develop and produce a
product in which there really is very little commercial
interest and that was the main motivating force behind the
original Bioshield legislation that was signed this past summer
by the President.
With regard to the points that I was trying to make is that
in all of us there is what we call ``a push and a pull
mechanism'' because if there is an arena of research that
unless it is explored, the concept proving for a particular
product will not occur. You can very rarely expect industry to
make a major investment, which they usually measure in hundreds
of millions of dollars to develop something in which there
really is no guarantee of a profit margin.
So what we need to do and have been doing, and that is what
I was referring to by my comment of the changing paradigm is to
push the process much more toward the development so that when
industry sees that there is something there, they can then take
that risk, and it is a risk for them, to get involved in doing
what needs to be done to produce and develop a product that
there will be a guaranteed purchase of.
That was the fundamental matrix and component of Bioshield
that was passed recently was to have that funding, but we need
to go beyond that. We need to continue to partner with
industry. To think that the government is going to be
successful in getting necessary countermeasures without close
collaboration with industry I think is folly. We have to
partner very closely. That is not only in the things that I
spoke about, but also in the things that this committee and
others in the Congress are trying to do by strengthening the
legislation, and I do believe that Bioshield I, as it is
referred to, has already been successful in helping us to get
to the goal, but we need to go further.
Senator Reed. Let me, if I may, raise another issue. It
seems to me, and this is oversimplification, is that we are
incentivizing private industry, which is important--I agree
with you--to collaborate so that ultimately they will sell
products to us, the monopoly purchaser, or the monopsony,
whatever the right term is. It seems to me that we might be
paying on both sides of the transaction. I mean giving them
incentives to produce it and then buying it all at the end. It
goes to this notion of limited commercial product value.
Dr. Fauci. You could interpret it that way, but I see it a
little bit differently. I see it that if we do not do that, we
are not going to have a product. We are just not. Because we
have examined the possibility of doing it all ourselves, and
that I do not think is a good idea because industry has the
expertise and the capability. It is very unique, the industry
in this country, which leads the world, so it seems to me that
the best approach would be to do what we are saying, even
though it could be interpreted as paying out of both ends. It
is so important for the national security that I think it is
worth doing.
Senator Reed. Let me--and I want Dr. Albright to also
comment on these issues--but a final question if I could. You
have got a strategy. We have passed Bioshield I. Where are the
big gaps now from your perceptive looking at your strategy?
What elements are missing? And, again, is it appropriated
programs that we have to put money towards or is it a gap in
this connection with private industry?
Dr. Fauci. I think these things need to be explored, which
is happening with industry in the components of the Congress
that have put forth both S. 3 as well as Bioshield II, and that
is what it is that the industry really wants? And the only way
you could find that is by discussing it with them because we
have tried over the years to get--and you cannot do them all
together because of the antitrust laws. You got to individually
go to each person and say what is it that you would feel would
be important to driving you toward getting us to the goal?
Some talk about liability, some talk about patent
protection, some talk about others. I think each of these need
to be carefully considered as to what the pros and the cons
are. But those are the most commonly mentioned gaps that we
have right now.
Senator Reed. Thank you, Doctor, and Dr. Albright, please.
Mr. Albright. I guess I would just want to echo a little
what Tony had to say. The whole point behind Bioshield was, in
fact, to incentivize industry. That was the purpose behind it.
Whether or not that level of incentivization is sufficient I
guess remains to be seen. We have just now gone out of the
chute with one procurement, the RPA procurement. Whether there
are additional needed incentives required in order to get the
kind of biodefense countermeasures in place is, I think, an
open question.
My view of this is, that what Bioshield has done has been
to substantially reduce the risk from the perspective of the
pharmaceutical industry with regard to whether or not they
should actually be involved. What we are basically telling them
is if you license the product, if you get it through licensure,
we are going to buy it, and we are going to buy a whole bunch
of it. In the RPA case, we are going to buy 25 million courses
of it.
Again, whether that works out on sort of a profit business
case for them is something that is very complex. In addition to
that, as Tony has pointed out, there are other issues which
have pervaded the industry for a long time and really have not
much to do with biodefense, have to do with patent protections,
liability issues and that sort of thing, and I certainly am not
qualified to talk much about them except to point out that I do
not think they are really biodefense specific issues.
Senator Reed. Thank you very much, gentlemen. Thank you,
Mr. Chairman.
Senator Burr. Senator Murray.
Senator Murray. Thank you, Mr. Chairman, for this hearing.
I was listening to Senator Reed talk about the private industry
infrastructure and whether it is going to respond. And I cannot
help but think, you know, with our latest experience with the
flu vaccine just this past year, and wondering since it is the
same infrastructure we are relying on to do all this, are we
solving the flu vaccine issue? Is that going to come back at us
again next year the same way?
Dr. Fauci. It likely will come back at us somewhat and the
general broad plan, Senator, has been to vaccinate more and
more people each year. If you look at the history of what has
come out of the department, just a few years ago we vaccinated
40 or 50 and then up to 60 and then 83 million last year, and
this year now that we are in, we were hoping to go beyond 100
million. We had a big monkey wrench thrown into things, the
contamination of the Chiron plant which essentially cut it in
half, which put us into a rather untenable position of trying
to hold back vaccinations for people who are not in the high
risk groups at the same time as we get people who are in the
high risk groups vaccinated.
We need to recover from that. That was a setback and the
recovery needs to, one, stabilize the market, and it gets to
the same industry interaction with government. We have got to
get the industry confident that we will be pushing for
vaccinating more and more people. We were aiming at 100. We
need to go beyond that. That number may be 150, 180 million and
what have you.
When industry sees that there is a stable market, they will
get much more involved because it is very risky when you are
dealing with something which the financial incentives are low,
the process of making the vaccine is risky and the market
fluctuates. We are trying to stabilize all of those. You can do
it by modernizing the process of making the vaccine, by
providing stable markets to know that you are going to be
recommending vaccines for many others.
So, in many respects, it relates to what we are saying
about biodefense. It is one of those things of having to be
able to partner in good faith and with good confidence in
industry together with the Federal Government.
Senator Murray. Thank you. I appreciate that. I know it is
not under the jurisdiction of this committee so called, but it
is related and I think we need to not lose our sight on that.
I did want to follow up. Senator Kennedy asked you about
the facility in Boston and the University of Washington, which
does a fantastic job in Seattle, has also been chosen to be a
Level 3 facility for NIH and I recognize the importance of
that. I think they do a great job, and we are really proud of
what they are doing, but there is a lot of concern within the
community and I wondered, following up on Senator Kennedy's
statement, you can tell us it is safe, but are you working with
the communities, with the universities, to help educate the
public about it so that they feel more comfortable with that?
Dr. Fauci. Indeed we are, Senator, and in fact dealing with
the community well ahead of time before you start building
things is absolutely critical. We have now enormous experience,
some of which is traumatic and some of which is very positive,
about needing to get the community to understand exactly what
you are doing, why you need to do it, and why you need to do it
in that site? The people in Seattle at that university I think
have done a good job of that.
They have been an example of how you should do it
correctly. Others throughout the country, not as well. We need
to strengthen the ties between the community because we find
almost invariably if they do not understand beforehand what you
are trying to do, there will be that natural reflex of
suspicion, and that is a natural response. That is not
something that should be criticized. It is a natural response.
So it is all in open transparent communication.
Senator Murray. OK. Very good. I had one question about the
Bioshield proposals, and I think it is really important that we
look at what worked, what is working, what is not working,
before we move forward down the line, and one of the things we
did was change the FDA approval process under Bioshield and
made a faster approval process, which I think we all agreed
needed to be done in order to expedite some of the products
that need to be out there to protect all of us.
But I am concerned that we have not placed a lot of focus,
both at FDA and NIH, on the longer-term effects of some of
these new treatments and vaccines and where we have
particularly seen this is a problem for our military personnel
who can be ordered to take new experimental treatments without
any long-term or postmarket surveillance being required by DOD
or NIH or FDA. This is probably a better question for FDA, but
I know that you work closely with them, and wanted to ask you
about how we are monitoring the long-term effects of this. The
Larium with the malaria treatment that military personnel were
ordered to take, we are now hearing about high suicide rates
and violence associated with that, and according to some of the
DOD officials, they are not even sure who received these
treatments so we can follow up with them.
I know that FDA has changed the labeling for that
treatment, but I am not sure if members of the military, a lot
of them who are civilians today, are even aware of that, and I
am not even sure if FDA or NIH is looking at these populations
once they leave the military.
That is just one example, but I wanted to ask you this
morning if you can tell me what steps NIH is taking to direct
research to postapproval or postmarket surveillance?
Dr. Fauci. In general, the research endeavor with regard to
a vaccine by NIH does not include late following of individuals
in a classic sense. We are doing more of that now in
partnership with the FDA in doing studies of follow-up of
people who are multiple years down the pike. This is something
that generally has not been part of the regimen of the
development and ultimate procurement and distribution of
vaccines, but you make a very good point. It is clear that
there are situations in which there are late effects and the
department in general, and the FDA particularly, is clearly
looking at that.
Senator Murray. OK. Very good. I think we need to really
focus on that because when we do expedite the procedures, we
want to make sure that any long-term effects that we do not
know during the research at the beginning becomes part of what
we use collectively. So thank you very much.
Senator Burr. Thank you, Senator. The chair will recognize
himself. Dr. Fauci, you alluded very quickly to the problem,
the potential problem, that antitrust laws have on our ability
to bring a world together and to address. Is there anything
that you would like to add to that comment?
Dr. Fauci. No, Mr. Chairman, the reason I made that
comment, and I am not at all an expert in this, and it would be
presumptuous for me to make any kind of recommendation, but I
can just put it into the context of how that happened. We were
trying to get a feel from the industry about what it is that
they really would like to see vis-a-vis incentives when we were
in the preparatory phase for the original Bioshield
legislation.
And it is extraordinary how concerned the legal counsel are
from industry to get more than one person on the same phone
call or in the same room because of the antitrust, so I had to
keep going from person to person alone. It was a very
interesting exercise. There is no such a thing as calling a
meeting. You cannot have a meeting except that there are
lawyers there who tell everybody to keep quiet so I was talking
to myself for awhile, and I thought that maybe if we could
loosen that up a little I would have been able to get more
information.
Senator Burr. Duly noted and it has come up before that
that is an area that we may need to look at. It is one that we
go into very delicately even in the conversation mode, but I
think it is safe to say that most members of both sides of the
Hill believe that well intended efforts like Bioshield usually
either slow down or do not happen because of a communication
breakdown, and clearly that is one of those obstacles that
stand in the way that over time may force you to find a way
around it rather than take it head on, and we may not enjoy the
full fruits of it.
Let me go to the push-pull methodology that you talked
about. I think that we all understand the push and I think for
the most part the fact that legislation passed, we all
understand the need for the pull. I want to take you in between
if I can. Talk to me about how robust the entities are to fill
that middle slot which is a guarantee to move product.
Dr. Fauci. That is an issue, Mr. Chairman--I am glad you
brought it up--because there is a middle gap there because, in
general, traditionally, the way the NIH research structure is
set up, we can only push so far into what is called advanced
development. When you have the pull mechanism, for example, of
our typical Bioshield legislation, which would sign a contract
with a company in which they get money only upon delivering of
a product, so it is much easier for a large pharmaceutical
company to take the risk of doing that advance development and
hope to ultimately be able to recoup the money when they get
paid for the contract that they sign. We are finding that in
some instances some of them cannot take that risk, particularly
the smaller biotech companies.
So what the NIH has been faced with is how far are we going
to push our dollars into advanced development, and that is
risky because that costs a lot of money and that comes out of
the basic research pool also. So we are struggling right now
with how far we can push into advance development to get the
companies confident enough that they know that this will
succeed so they can go through the Bioshield mechanism.
Senator Burr. And when in the pull part of that methodology
you begin to alter what a company can do with that product,
over and above the guaranteed sale to the Federal Government,
what effect does that then have on the large pharma companies
and their willingness to participate?
Dr. Fauci. Well, obviously, restrictions on what they can
do with that is something that is chilling to them. They feel,
at least in my conversations--I am not speaking about any
official policy on our part--but they feel that they would like
much more flexibility in what they can do with a particular
product. For example, a dual use product, a product that could
go into the National Strategic Stockpile for biodefense, but
they could also use them for something else. There are strict
limitations on that.
Senator Burr. Is it safe to say that the Orphan Drug Act
happened because we saw the companies were not willing to
invest the research dollars because the end-game was so small?
Dr. Fauci. Right.
Senator Burr. In relation to everything else they could do?
Dr. Fauci. Yes. The answer is they are related, Mr.
Chairman.
Senator Burr. And that is very similar to what we are
dealing with here relative to how many might meet that goal of
fulfilling the contract at the end?
Dr. Fauci. That is correct.
Senator Burr. Real quickly, Dr. Albright, you talked about
the need to create a biologic footprint or fingerprint--excuse
me. For Senator Roberts, that might be a footprint.
[Laughter.]
Senator Roberts. Or a hoof print.
Senator Burr. But a bioforensic analysis center. How close
are we to that? How realistic is that goal?
Mr. Albright. It is operating today. It is actually taking
in thousands of samples every month we get from a wide variety
of sources. It is done in close coordination with the FBI. The
FBI is a partner. They actually have staff up there, and the
need for this was actually a direct result of the anthrax
attacks in 2001. I mean something as simple as needing a
facility where you can store mailboxes that are contaminated
and then treat them as evidence and then what we had right
after that attack was a relatively ad hoc activity for
sequencing the samples, genetically sequencing them, doing more
traditional forensics, things like examining how is the thing
milled and what other contaminants might be in the sample and
that sort of thing.
What we have now done is we have established this National
Biological Bioforensic Center up at Fort Detrick, and it is
there now. It is operating.
Senator Burr. Clearly we have made significant advances in
our ability of the forensic.
Mr. Albright. Absolutely.
Senator Burr. We are not as far along as it relates to
therapies or antivirals or something that enables us not to
have to go through that process.
The chair would recognize Senator Roberts for several
questions with answers.
Senator Roberts. I would be happy to yield to the
distinguished chairman if he has any questions at this point.
The Chairman. I thank you. I will submit some questions.
The ones I have are the accountant type that are so detailed
that hardly anybody would be interested in them but me.
[Laughter.]
[Question submitted by Senator Enzi follow:]
Question of Senator Enzi to Penrose C. Albright, Ph.D.
Question 1. In your written testimony you mention national
biodefense for agriculture. Specifically you mention Foot-and-Mouth
disease and soy bean rust. Could you briefly describe DHS efforts in
regard to agrobioterrorism?
Senator Roberts. I study those, Mr. Chairman, every time
that you have those. Let me just say that, Dr. Fauci, do not
worry about talking to yourself. We do that a lot up here. Six
of the 19 hijackers in regards to the World Trade Center attack
had extensive agriculture training. Some evidence that the crop
dusters that were in question back during that time were not
for people but for crops. Noting the bioagents that are
available in Pakistan and Iran, Russia, more especially Russia,
in places like Obolensk and others, that is why I am so
concerned about this, not only in terms of people, but
agriculture and our Nation's food supply.
We have heard a lot about vaccine disease research for
potential bioagent threats, and it is very important. I am
interested in whether or not you have conducted or looked into
conducting similar research on vaccines for animal diseases
that could be used as a bioagent?
Mr. Albright. Absolutely. We are, as you know, partnered
with USDA up at Plum Island and the Department of Homeland
Security is very focused on the development of a wide variety
of countermeasures that range from development of new vaccines
for things like Foot-and-Mouth disease which is probably the
highest consequence of all the threats that we are concerned
about, including also rapid diagnostics, the ability, for
example, to deploy potentially to the field triage systems,
that sort of thing.
In the 2006 budget, as a matter of fact, there is
substantial additional dollars in the Department of Homeland
Security's budget to develop the next generation Foot-and-Mouth
disease vaccine. Now this is done in partnership with
Agricultural Research Service which tends to do some of the
more fundamental research and we tend to be more focused more
on the developmental side, kind of filling the gap, in a sense,
in the ag side that Dr. Fauci mentioned exists on the public
health side of the fence. But, yes, we are absolutely involved
in that.
Senator Roberts. Well, then there is SARS and avian
influenza that make the papers about every other month in terms
of we have the sort of terrorist threat of the month, which is
unfortunate because it sort of drives TTIC and other matters.
But we have currently in place rapid response teams. We used to
call them raid teams. That was on the Armed Services Committee.
Then we changed that to CST teams and for the life of me I
cannot tell you what CST stands for. To get it appropriated, we
were going to call it the Ted team or the Bob Team, but there
has been a change, so I think probably Terrorism Homeland
Advanced Detail, which is THAD, of course. Being the chairman
of the Appropriations Committee, I thought they may get funded.
But they were to quickly deploy within 4 hours of anybody or
any incident to get back to the national folks and say this is
what we are dealing with, and with the many, many exercises
that we have had, and one of my questions is are you planning
exercises, and I hope that you are, this would become
absolutely crucial.
Are you doing any work to develop a similar team to deal
with agriculture and food security issues or are the current
teams trained in this area as well?
Mr. Albright. Well, first, a response to the point about
exercises, yes, we do exercises all the time.
Senator Roberts. Good.
Mr. Albright. We actually have a group of people who spend
all their time planning exercises and TOPOFF III is coming up,
for example.
Senator Roberts. You scared the hell out of us with Dark
Winter, by the way.
Mr. Albright. Right.
Senator Roberts. That was a seminal event.
Mr. Albright. Yes, well, you know, we have pretty wild
imaginations. It is not hard to come up with scenarios that
keep you awake at night. With regard to rapid response teams in
the agricultural area, that would be something that USDA would
be primarily focused on and not the department, and I really do
not know the answer to what they have in existence. So what I
would like to do is just get back to you with that one.
Senator Roberts. OK. I think perhaps in the Intelligence
Committee, we ought to have CDC, NIH, FDA, USDA, and we will
toss in a few more, and maybe we could have a good panel
discussion about this because in terms of a national threat,
Mr. Chairman, I think it is extremely important. Senator Burr
has left, as has everybody else, but at any rate I want to
thank him for his leadership. I want to thank you for your
leadership in having this subcommittee hearing, and I
especially want to thank the witnesses. Gentlemen, persevere,
because this is going to be a threat and a challenge for us for
some time to come, and thank you for the job that you are
doing.
The Chairman. I want to thank the panel for their testimony
and their answers and we will be submitting some more questions
in writing, if you would be so kind as to get those back to us
so we can finish our planning on biodefense.
The Chairman. Thank you. If the next panel would take their
place.
Senator Burr. As our witnesses are moving to the table, let
me take an opportunity to reintroduce Gerald Epstein, the
Senior Fellow of Science and Security at the Center for
Strategic and International Studies, Homeland Security Program;
Mr. Gordon Cameron, CEO of Acambis, a biotechnology company
with facilities in Massachusetts; Dr. Jon Abramson, the chair
of Pediatrics at Wake Forest Baptist Medical Center, and a
member of the CDC Advisory Committee on Immunization Practices;
and George Painter, the President and CEO of Chimerix in the
Research Triangle Park.
Gentlemen, we welcome all of you. We have already made
arrangements that your full testimony is to be included as part
of the record, and if you have no objections in the order that
we go through, I will start to your right and my left and
recognize Dr. Painter.
STATEMENTS OF GEORGE PAINTER, PH.D., CEO, CHIMERIX, INC.; JON
ABRAMSON, M.D., PROFESSOR AND CHAIR, DEPARTMENT OF PEDIATRICS,
WAKE FOREST UNIVERSITY SCHOOL OF MEDICINE, WINSTON-SALEM, NORTH
CAROLINA; GERALD L. EPSTEIN, SENIOR FELLOW FOR SCIENCE AND
SECURITY, HOMELAND SECURITY PROGRAM, CENTER FOR STRATEGIC AND
INTERNATIONAL STUDIES; AND GORDON CAMERON, CEO, ACAMBIS, PLC
Mr. Painter. Thank you, Mr. Chairman, and committee. I
appreciate the opportunity to be here and speak to you on the
current state of biodefense preparedness and the capacity of
the biotechnology and pharmaceutical industries to respond to
the biodefense needs of the United States.
I appear before you today as the Chief Executive Officer of
Chimerix, Inc., an emerging biotechnology company that is in
Research Triangle Park, North Carolina. My testimony is based
on over 25 years of experience in the biotechnology and
pharmaceutical industry. My primary focus and experience is in
drug development, taking drugs from the early discovery stage
through approval of the regulatory process to
commercialization, specifically in the area of antiviral drugs.
From my perspective, there are two primary challenges
facing the emerging biodefense industry. First, it is
imperative that existing animal models of viral infection be
further developed to a level that will allow drug developers to
provide the Food and Drug Administration with the data
necessary to ensure the safety and efficacy of these biodefense
medicines.
Second, the Department of Health and Human Services must
ensure that the Project Bioshield Act of 2004 is implemented in
such a way to convince investors in biotechnology such as
Chimerix that a successfully developed biodefense
countermeasure can be purchased for the Strategic National
Stockpile in a predictable and timely manner.
With support in funding by the National Institute of
Allergy and Infectious Disease and funding from private venture
capital firms, Chimerix has initiated an aggressive program
focused on the development of an oral antiviral drug for the
prophylaxis and treatment of smallpox. Originally, the primary
goal of our effort was to produce a therapeutic alternative to
vaccination to provide protection for the up to 50 million
Americans who cannot be vaccinated as a result of compromised
immune systems.
This population includes people with cancer, people who
have undergone organ transplants, pregnant women and small
infants, families of people living with common skin disorders
such as eczema and atopic dermatitis, and people living with
HIV/AIDS.
While this existing gap in our Nation's preparedness alone
warrants investment in the development of safe and effective
antiviral treatments, last year, straightforward genetic
engineering techniques were used to create a model virus
related to smallpox that can allude vaccines and produce 100
percent mortality in mice that were already vaccinated. Were
these methods successfully applied to the smallpox virus,
variola major, the United States would be left defenseless
despite the availability of vaccine.
The single-most critical tool in this effort is relevant
animal models that can provide data to ensure the efficacy and
determine the appropriate human dose of new drugs. It is both
impractical and unethical to study the efficacy of a potential
treatment for virulent diseases such as smallpox in humans.
Therefore, critical efficacy data must be gathered in animal
models under the FDA's animal efficacy rule. The data gathered
in that rule takes the place of clinical trials, Phase II/Phase
II clinical trials that are usually used to justify the
approval and registration of a drug.
Simply put, without a good model, Chimerix nor any other
company can develop a good antiviral for the treatment of
smallpox infection. While a great deal of excellent research
has been undertaken by both the Federal Government and the
private sector in response to this critical need, current
animal models in mice, rabbits, monkeys, using test viruses,
mousepox, cowpox, monkeypox, even variola, human smallpox, are
currently inadequate to fully support drug development. Thus,
further development of treatments for smallpox is essentially
stalled.
Existing animal models cannot, for example, address two key
issues that have arisen out of discussions between the FDA and
Chimerix on the company's smallpox drug candidate.
First, the disease produced in the animals needs to be
analogous as possible to the disease that is going to be seen
in humans. In current animal models, the rate and degree of
appearance of the infection in the blood is dependent on the
type and strain of the pox virus used, the route of infection--
is it IV, is it nasal, is it inter-tracheal, is it aerosol--and
how much of the virus is used in the infection. We currently do
not know which of these test conditions are appropriate in
modeling the human disease.
Second, the treatment in animals need to provide the basis
for guiding physicians in the treatment or prophylaxis of a
person who has the disease. In order to meet this condition,
not only must the disease model be correct, but the uptake,
distribution and elimination profile of the drug in the animal
must be translatable, directly translatable to that in a human.
Resolving these issues is absolutely critical in allowing
us to determine what dose of the drugs should be given, how
soon before exposure the drug can be given, and have a good
prophylactic effect, and how long after the disease has begun
to manifest itself that we can treat someone and still be
assured of their recovery.
There is no doubt these issues can be resolved with more
effort. However, from a practical standpoint, this will require
a significantly higher application of resources since animal
experiments are both costly and time consuming, key issue being
time.
Additionally, this process can be expedited by creating
expanded working groups in which people with experience in drug
development meet with animal modeling experts and present are
appropriate representatives from the CDER branch of the FDA.
On Friday, I returned from a trip to Russia with a
delegation led by Congressman Weldon. On my own initiative, I
was able to meet with and talk extensively to the leading
former Soviet virologist to obtain information and insight into
their experience. Given the widely reported experience of the
Soviet Union with smallpox long after the eradication of the
disease, these scientists many of whom are now quite elderly,
possess a great deal of information about the course of the
disease. While I have no doubt the United States has already
learned a great deal of information from these individuals,
their knowledge about the course of the disease could
enormously supplement our understanding and help expedite
development of animal models to allow drugs such as those being
developed by Chimerix to enter the Strategic National Stockpile
sooner. I would strongly encourage Congress to consider support
of such interactions as part of Project Bioshield.
Recognize that any uncertainty by investors in companies
developing countermeasures caused by unpredictable issues and
regulatory challenges such as the animal rule have the direct
effect of increasing the cost of developing these
countermeasures which in turn are passed on to the taxpayer
when the drug is purchased for the stockpile.
Of course, there is always the very clear danger that these
challenges drive private investment away entirely, thereby
threatening the capacity to produce countermeasures at any
price. Coupled with the already uncertain environment
surrounding the creation of the emerging biodefense industry,
the lack of a clear animal rule is potentially crippling to the
development of the warm manufacturing base needed for
countermeasure development.
I appreciate the opportunity to speak to you today and
happy to answer any questions.
Senator Burr. Thank you, Dr. Painter.
[The prepared statement of Mr. Painter follows:]
Prepared Statement of George Painter PH.D.
Chairman Burr, Senator Kennedy, and members of the committee, it is
an honor for me to testify before you today regarding the current state
of biodefense preparedness and the capacity of the biotechnology and
pharmaceutical industries to respond to the biodefense needs of the
United States.
I appear before you today as the Chief Executive Officer of
Chimerix, Inc. Chimerix is an emerging biotechnology company based in
Durham, North Carolina. The company was founded in 2002 to harness a
technology developed by Dr. Karl Hostetler, professor of medicine at
the University of California, San Diego, and is applying this
technology to an existing, FDA licensed antiviral medication for AIDS
patients in order to make it effective against orthopoxviruses, in
particular, smallpox.
My testimony is based on over 25 years of experience in the
biotechnology and pharmaceutical industry. During my career, I have
worked for both large pharmaceutical companies such as Burroughs
Wellcome Co. (now part of GlaxoSmithKline) and small biotechnology
companies such as Triangle Pharmaceuticals, also based in North
Carolina (now owned by Gilead Sciences). My primary focus and
experience is in the development of effective treatments against
viruses such as Hepatitis B and HIV, including being the inventor of
lamivudine-HBV for the treatment of hepatitis B and being a member of
the development team for AZT, perhaps the most widely used HIV
treatment in the world.
Let me begin by thanking the committee for its leadership in this
critical public health and national security area. The work of this
committee's members, including the leadership of Senator Burr while in
the House of Representatives and Senator Kennedy with former-Chairman
Gregg in the Senate, in the passage of the Project Bioshield Act of
2004 was a credit to each of you. I applaud President Bush for his
vision in announcing Project Bioshield in his 2003 State of the Union
Address and look forward to working with Senator Gregg and this
committee to see passage of S. 3 this year to further strengthen the
Nation's biopreparedness.
From my perspective, there are two primary challenges facing the
emerging biodefense industry. First, it is imperative that existing
animal models of viral infection be further developed to a level that
will allow drug developers to provide the Food and Drug Administration
(FDA) with the data necessary to ensure the safety and efficacy of
needed biodefense medicines. Second, the Department of Health and Human
Services (HHS) must ensure that the Project Bioshield Act of 2004 is
implemented in a way to convince investors in biotechnology companies
such as Chimerix that a successfully developed biodefense
countermeasure can be purchased for the Strategic National Stockpile in
a timely and predictable manner. Both of the goals are easily
achievable.
With support and funding by the National Institute of Allergy and
Infectious Disease (NIAID) and funding from private venture capital
firms, Chimerix has initiated an aggressive program focused on the
development of an oral antiviral drug for the prophylaxis and treatment
of one of the most deadly diseases known to man, smallpox. While
naturally occurring smallpox was eradicated almost 30 years ago by the
World Health Organization's vaccination program, the events of 2001
have made it clear that terrorists can obtain and will use dangerous
pathogens to attack our country. Originally, the primary goal of our
efforts was to produce a therapeutic alternative to vaccination to
provide protection for the up to 50 million Americans who cannot be
vaccinated against smallpox as a result of compromised immune systems.
This population includes people with cancer, people who have undergone
organ transplant, pregnant women and infants, people and the families
of people with common skin disorders such as eczema and atopic
dermatitis and people living with HIV/AIDS. While this existing gap in
our Nation's preparedness alone warrants investment in the development
of safe and effective antiviral treatments against deadly smallpox,
last year, straightforward genetic engineering techniques were used to
create a model virus related to smallpox that can elude vaccines and
produce 100 percent mortality in vaccinated mice. Were these methods
successfully applied to the smallpox virus, variola major, the United
States would be left completely vulnerable to attack despite the
availability of smallpox vaccines.
Against this backdrop, Chimerix has worked diligently to pursue the
development of a safe and effective smallpox drug and to expedite the
drug development process as much as possible. Reaching this goal
requires, in essence, that a new, accelerated paradigm for the
discovery and development of antiviral drugs be defined. If
successfully implemented, this new paradigm could help protect
Americans not only against biological terrorist attacks, but also
against emerging infectious diseases such as SARS.
The single most critical tool in this effort is relevant animal
models that can provide data to ensure the efficacy and determine the
appropriate human dose of these new drugs. It is both impractical and
unethical to study the efficacy of a potential treatment for virulent
diseases such as smallpox in humans. Therefore, critical efficacy data
must be gathered in animal models. Under the FDA's animal efficacy
rule, this data is used in place of the standard Phase II and Phase III
clinical trials to support registration of the drug. Thus, animal
models acceptable to both drug developers and the FDA are absolutely
essential to the successful development of biodefense medicines. Simply
put, without an appropriate animal model, neither Chimerix nor any
other maker of antiviral drugs will be able to develop medicines to
treat smallpox infection. While a great deal of excellent research has
been undertaken by both the Federal Government and the private sector
in response to this critical need, current animal models in mice,
rabbits, and monkeys using test viruses such as mousepox, cowpox,
vaccinia, monkeypox, and even human smallpox, are inadequate to fully
support drug development under the FDA's animal efficacy rule. Thus,
further development of treatments for smallpox is stalled.
Existing animal models cannot, for example, address two key issues
that have arisen out of discussions between the FDA and Chimerix on the
company's smallpox drug candidate. Firstly, the disease produced in
animals needs to be as analogous as possible to the disease that would
be seen in a human infected with smallpox. In current animal models,
the rate and degree of appearance of the infection in the blood is
dependent on the type and strain of the poxvirus used, the route of
infection and how much virus is used to induce the infection. We
currently do not know which test conditions produce the best model of
human disease. Secondly, the treatment in animals needs to provide the
basis for guiding physicians in the treatment or prophylaxis of human
disease. In order to meet this condition not only must the disease
model be correct but the uptake, distribution and elimination profile
of the drug in the animal must be translatable to that in a human.
Resolving these issues is absolutely critical in allowing us to
determine what dose of the drug should be given, how soon before
exposure the drug can be given to have a prophylactic effect, and how
long after the disease has begun to manifest itself that we can treat
someone and be assured of their recovery.
There is no doubt these issues can be resolved with more effort.
However, from a practical standpoint this will require a significantly
higher application of resource since animal experiments are both costly
and time consuming. Additionally this process can be expedited by
creating expanded working groups in which people with experience in
drug development, animal modeling experts and representatives from the
FDA CDER branch all participate. Finally, companies that are working to
develop biodefense countermeasures and who are consequently gaining
first hand experience in the use of the animal efficacy rule must be
incentivized to participate in and contribute to these programs despite
the fact that the models and their data will be made available to
competitors.
On Friday, I returned from a trip to Russia with a delegation led
by Congressman Curt Weldon (R-PA). On my own initiative, I was able to
meet with and talk extensively to the leading former-Soviet virologists
to obtain information and insight into their experience. Given the
widely reported experience of the Soviet Union with smallpox long after
the eradication of the disease, these scientists, many of whom are
quite elderly, possess a great deal of information about the course of
the disease. While I have no doubt the United States has already
learned a great deal of information from these individuals, their
knowledge about the course of the disease could enormously supplement
our understanding and help expedite development of animal models to
allow drugs such as those being developed by Chimerix to enter the
Strategic National Stockpile as quickly as possible. I would strongly
encourage Congress to consider support of such interactions as part of
Project Bioshield. I look forward to working with FDA and our partners
at NIAID, to explore whether the information available from Russian
scientists can help expedite development of proper animal models, and
thus, the development of safe and effective treatments against
smallpox.
The very practical concerns that require companies such as Chimerix
to depend upon the animal rule creates enormous challenges in
sustaining a private market solution for development and manufacture of
medicines such as our smallpox antiviral. Chimerix, like most
biotechnology companies, is funded by private equity investors that
must be able to analyze and predict a reasonable return on their
investment. Thus, the immediate development of animal models that
produce data with the most predictive value is critical not only to
ensure the safety and efficacy of these drugs to satisfy the FDA, but
also to permit a sustainable business model to allow private entities
to continue to participate in the emerging biodefense industry. Without
addressing this problem, the United States and, indeed, the world will
be left without a safe and effective drug for the treatment of
smallpox.
In addition to addressing the animal rule, Project Bioshield must
be implemented in a way to allow the investment community the ability
to assess and predict with some degree of accuracy the likelihood that
a private entity such as Chimerix can generate an adequate return on
investment through development of biodefense countermeasures. The
recent award of a large contract for a single vaccine technology to a
single company to address anthrax has caused some questions to be
raised in the investment community about whether the market is viable
for companies developing technologies such as Chimerix's that may be
used as part of a drug cocktail. Moreover, it is unclear from the
recent request for proposals issued by HHS for countermeasures whether
there will be enough certainty regarding the number of doses that are
to be procured to attract private investment.
Recognize that any uncertainty by investors in companies developing
countermeasures caused by unpredictable markets and regulatory
challenges such as the animal rule have the direct effect of increasing
the cost of developing these countermeasures, which in turn, are passed
on to the taxpayer when the drug is purchased for the stockpile. Of
course, there is also the very clear danger that these challenges drive
private investment away entirely, thereby threatening the capacity to
produce countermeasures at any price. Coupled with the already
uncertain environment surrounding the creation of the emerging
biodefense industry, the lack of a clear animal rule is potentially
crippling to the development of the warm manufacturing base for needed
countermeasures.
I very much appreciate the opportunity to offer testimony on this
very important public health and anti-terrorism issue. Achieving the
objectives of the Project Bioshield Act of 2004 and the Protecting
America in the War on Terror Act of 2005 recently introduced in the
Senate by Senator Gregg as S. 3 are of the utmost importance to
ensuring homeland and national security. Again, I applaud your efforts,
and the efforts of President Bush and his administration, and look
forward to continuing our work with the Department of Defense, HHS and
NIH in this critical area.
I am happy to respond to any questions you may have.
Senator Burr. Dr. Abramson.
Dr. Abramson. Good morning, Mr. Chairman and members of the
committee. I am Jon Abramson, Physician-in-Chief of Brenner
Children's Hospital and Chair of the Department of Pediatrics
at Wake Forest University School of Medicine. I am a pediatric
infectious disease specialist. I am the immediate past Chair of
the Committee on Infectious Diseases of the American Academy of
Pediatrics and currently serve on the Advisory Committee on
Immunization Practices to the CDC.
I have served on the CDC's anthrax working group and have
co-authored AAP policy statements on the impact of bioterrorism
on children and the use of smallpox vaccine in children. I have
been asked today by Senator Burr to speak to the Bioterrorism
Subcommittee regarding the issue of liability and its impact on
being able to effectively plan for and minimize the impact of a
bioterrorist attack.
The opinions today that I express are my own and do not
represent those of Wake Forest University School of Medicine,
the Academy of Pediatrics, the CDC or any other organization.
Immunization is one of the greatest public health
achievements of the 20th century and has saved millions of
lives. Thanks to the widespread use of vaccines, millions of
children and adults have avoided terrible diseases that cause
great suffering and even death. For example, before
immunization, smallpox caused death in approximately 30 percent
of those infected and serious morbidity in many other children
and adults.
This disease has now been eradicated from the planet, an
unprecedented accomplishment made possible due to the
introduction of the smallpox vaccination throughout the world.
Polio, a disease that previously paralyzed approximately
350,000 people worldwide annually will be eradicated during the
next decade. In the United States immunizations have reduced by
more than 95 percent of the vaccine preventable diseases
including measles, whooping cough, tetanus, Hemophilus
influenza, previously the most common cause of bacterial
meningitis in children.
These vaccines have proven to be very cost effective means
for preventing these and other serious infectious diseases.
Despite this reduction of disease due to the immunization
program, the fragility of the vaccine supply has never been
greater, as demonstrated by the recent shortage of multiple
vaccines including most recently those that prevent influenza
and pneumococcal disease. The reasons for these shortages are
multiple and include:
Many of the vaccine manufacturing plants are old and a
considerable investment would be needed to update the plants to
meet current FDA standards for good manufacturing practices;
Two, the price of older vaccines is relatively low and the
profit potential is greater in other therapeutic areas. This
relatively low profitability has led to a number of companies
discontinuing a production of some or all of their vaccine
products.
The risk of a large liability suit recently has increased
despite the protection afforded companies and health care
providers by the National Vaccine Injury Compensation Program.
For example, some attorneys are attempting to bypass the VICP
and bring the allegations that vaccine can cause autism
directly to the court.
While each of these reasons contributes to the fragility of
the vaccine supply, today I will focus my remarks on the impact
that liability and compensation concerns have in allowing us to
adequately prepare for the widespread public health emergency
such as might occur due to emerging infections in nature such
as pandemic flu or a bioterrorist attack.
Indeed, the recent experience with smallpox vaccine clearly
demonstrated the effect that liability concerns had on
implementing a preventable program designed to protect the
American public from a smallpox bioterrorist attack. Some of
the liability and compensation problems that arose are as
follows:
One, biotechnology companies were reluctant to produce a
vaccine unless a national liability program was enacted that
would hold manufacturers harmless against any lawsuit that
arose from those who developed complications or died as a
result of the vaccine.
Two, many medical centers struggled with developing a
smallpox vaccination program that would allow them to fulfil
President Bush's request to immunize groups of health care
workers at various hospitals to care for people infected with
smallpox.
Even when the President and Congress assumed liability
risks for physicians and hospitals, many did not participate in
this program. This was due in part to other liability and
compensation issues including liability protection offered did
not include injury compensation for health care workers,
patients, or household contacts who might accidentally be
inoculated with the vaccine virus.
The current Vaccine Injury Compensation Program that was
created in the 1980s did not afford the liability and
compensation protection necessary to implement a mass
vaccination program such as might be needed in a bioterrorist
attack or pandemic.
In the 108th Congress, Majority Leader Frist introduced a
bill, The Improved Vaccine Affordability and Availability Act,
that if passed would have strengthened and made several
important modifications to the VICP that would significantly
help with liability and compensation issues that arise from the
routine U.S. vaccination program
However, it was not the intent that the proposed
legislation addressed a widespread public health emergency
where rapid vaccination of a very large percentage of the
population would be needed to maximally protect both the
individuals as well as society.
The Project Bioshield Act of 2004 and the Safety Act
attempt to deal with some of these liability issues that arose
in response to the smallpox vaccine program, but these pieces
of legislation do not go far enough.
So what is needed today to be done to minimize the impact
of a bioterrorist attack? Congress needs to enact a no fault
mechanism that covers not only bioterrorist attack but any
widespread public infectious disease outbreak where emergency
interventions such as vaccination would be done on a large-
scale basis. It should protect vaccine manufacturers and health
care providers from lawsuits due to the potential side-effects
of the vaccine and compensate children and adults injured
directly or indirectly by the vaccines that are recommended to
prevent bioterrorism inflicted disease.
While the Vaccine Injury Compensation Program does need to
be modernized and strengthened, any program to address
immunizations in the face of a widespread outbreak should be a
system separate from the VICP and encompass all circumstances
where mass emergency immunization would be necessary.
The program needs to have the following components:
One, protection of the vaccine manufacturer against
lawsuits should be absolute except in the case of gross
negligence. What do I mean by that? For instance, a failure to
follow good manufacturing procedures during the production and
distribution of the vaccine.
Two, health care workers and medical facilities
participating in the immunization program need complete
protection against lawsuits unless they violate standard
medical procedures when administering the vaccine. For
instance, failure to change needles when withdrawing vaccine
from a multidose vial.
Three, those who develop a complication due to the vaccine
should be reimbursed for their medical costs and lost earnings,
but should not receive punitive damages.
Although the liability and compensation issues raised by a
widespread public health emergency due to an infectious agent
are multiple and complex, the overall goal is simple: the
ability to make the necessary vaccines, administer them to a
large number of people, and have a public willing to be
immunized. Those events must occur in consecutive order to
minimize the impact of such an event.
The Federal Government is the only entity in a position to
declare that mass vaccination is necessary and prioritize those
who would receive the vaccine. As such, the Federal Government
is the logical entity to provide the compensation.
Similar liability and compensation issues will occur if
experimental drugs are used to treat patients infected with
microbial agents. For example, there are currently no FDA
approved drugs to treat smallpox although several antiviral
agents are under development. In the event of a smallpox
bioterrorist attack, one or more of these drugs might need to
be used in an attempt to decrease mortality. The liability and
compensation issues and recommendations that I have just
discussed for vaccines would also apply to antimicrobial
agents.
I urge Congress to thoughtfully, yet quickly, address the
need to develop a compensation program to deal with the
specific issues raised by a bioterrorist attack. It is critical
to minimizing the impact of such an attack on the public
health. I thank the committee for letting me testify and would
be happy to answer any questions.
Senator Burr. Thank you, Dr. Abramson.
[The prepared statement of Dr. Abramson follows:]
Prepared Statement of Jon Abramson, M.D.
summary statement
Immunization is one of the greatest public health achievements of
the 20th century and widespread use of vaccines has prevented millions
of people from contracting diseases that can cause great suffering and
death. Unfortunately, today the risk of a widespread bioterrorist
attack is real and the development and use of vaccines is a critical
component to minimize the impact of such an attack. The recent
experience with smallpox vaccine clearly demonstrated how liability and
compensation concerns can have negative impact on our ability to
implement a preventive program designed to protect the American public
from bioterrorism.
The current national Vaccine Injury Compensation Program (VICP)
that was created in the 1980s does not afford the liability and
compensation protection necessary to implement a mass vaccination
program. Congress needs to enact a ``no fault'' mechanism that could be
modeled after the VICP, but needs to be more comprehensive to allow for
mass vaccination. This program needs to have the following components:
(1) Protection of the vaccine manufacturer against lawsuits should
be absolute except in the case of gross negligence (e.g., failure to
follow good manufacturing procedures during the production and
distribution of the vaccine).
(2) Health care workers and medical facilities participating in the
immunization program need complete protection against lawsuits unless
they violate standard medical procedures when administering the vaccine
(e.g., failure to change needles when withdrawing vaccine from a
multidose vial).
(3) Those who develop a complication due to the vaccine should be
reimbursed for their medical costs and lost earnings, but should not
receive punitive damages.
Although the liability and compensation issues raised by a
widespread public health emergency due to an infectious agent,
including those caused by a bioterrorist attack, are multiple and
complex, the overall goal is simple. The ability to make the necessary
vaccines, administer them to a large number of people and have a public
willing to be immunized are three events that must occur in consecutive
order to minimize the impact of this type of event. Similar liability
and compensation protection also needs to be extended to those
producing and receiving experimental drugs needed to treat an
infection.
______
Good morning, Mr. Chairman and members of the committee, I am Jon
Abramson, M.D. Chair, Wake Forest University Physicians, Physician-in-
Chief, Brenner Children's Hospital and Weston M. Kelsey Professor and
Chair of Pediatrics at Wake Forest University School of Medicine. I am
a pediatric infectious disease specialist. I am the immediate past
Chair of the Committee on Infectious Diseases of the American Academy
of Pediatrics (AAP) and currently serve on the Advisory Committee on
Immunization Practices of the Centers for Disease Control and
Prevention (CDC). I have served on the CDC anthrax working group and
have coauthored AAP policy statements on the impact of bioterrorism on
children and the use of smallpox vaccine in children. I have been asked
by Senator Burr to speak to the Bioterrorism Subcommittee regarding the
issue of liability and its impact on being able to effectively plan for
and minimize the impact of a bioterrorist attack. The opinions I
express today are my own and do not represent those of Wake Forest
University School of Medicine, the AAP, CDC or any other organization.
Immunization is one of the greatest public health achievements of
the 20th century and has saved millions of lives. Thanks to the
widespread use of vaccines, millions of children and adults have
avoided terrible diseases that can cause great suffering and even
death. For example, before immunization, smallpox caused death in
approximately 30 percent of those infected and serious morbidity in
many other children and adults. This disease has now been eradicated
from the planet, an unprecedented accomplishment made possible due to
the introduction smallpox vaccination throughout the world. Polio, a
disease that previously paralyzed approximately 350,000 people
worldwide annually, will likely be eradicated during this decade. In
the United States immunizations have reduced by more than 95 percent
other vaccine-preventable infectious diseases including measles,
whooping cough, tetanus, and Haemophilus influenzae, previously the
most common cause of bacterial meningitis in children. These vaccines
have proven to be a very cost-effective means for preventing these and
other serious infectious diseases.
Despite the great reduction of disease due to the immunization
program, the fragility of the vaccine supply has never been greater, as
demonstrated by recent shortages of multiple vaccines including most
recently those that prevent influenza and pneumococcal disease. The
reasons for these shortages are multiple and include:
(1) Many of the vaccine manufacturing plants are old, and
considerable investment would be needed to update the plants to meet
current FDA standards for good manufacturing practices.
(2) The price of older vaccines is relatively low and the profit
potential is greater in other therapeutic areas. This relatively low
profitability has led to a number of companies discontinuing production
of some or all of their vaccine products.
(3) The risk of large liability suits recently has increased
despite the protection afforded companies and health care providers by
the national Vaccine Injury Compensation Program (VICP). For example,
some attorneys are attempting to bypass the VICP and bring the
allegation that vaccines can cause autism directly into court.
While each of these reasons contribute to the fragility of the
vaccine supply, today I will focus my remarks on the impact that
liability and compensation concerns have in allowing us to adequately
prepare for a widespread public health emergency such as might occur
due to emerging infections in nature (e.g., pandemic influenza) or a
bioterrorist attack. Indeed, the recent experience with smallpox
vaccine clearly demonstrated the effect that liability concerns had on
implementing a preventive program designed to protect the American
public from a smallpox bioterrorist attack. Some of the liability and
compensations problems that arose are as follow:
(1) Biotechnology companies were reluctant to produce a vaccine
unless a national liability program was enacted that would hold
manufacturers harmless against any lawsuits that arose from those who
developed complications or died as a result of the vaccine.
(2) Many medical centers struggled with developing a smallpox
vaccination program that would allow them to fulfill President Bush's
request to immunize a group of healthcare workers at various hospitals
to care for people infected with smallpox. Even after the President and
Congress assumed liability risk for physicians and hospitals, many did
not participate in the smallpox immunization program due, at least in
part, to liability and compensation issues. This was because the
liability protection offered did not include injury compensation for
healthcare workers' patients or household contacts who might be
accidentally inoculated with the vaccine virus.
The current VICP was created in the 1980s and does not afford the
liability and compensation protection necessary to implement a mass
vaccination program, such as might occur from a bioterrorist attack or
a pandemic. In the 108th Congress, Majority Leader Bill Frist (R-TN)
introduced a bill, the Improved Vaccine Affordability and Availability
Act (S. 754) that, if passed, would have strengthened and made several
important modifications to the VICP that would significantly help with
liability and compensation issues that arise from the routine U.S.
vaccination program. However, it was not the intent that this proposed
legislation address a widespread public health emergency where
vaccination of a very large percentage of the population would be
needed to maximally protect both the individual as well the population
as a whole.
So what needs to be done to minimize the impact of a bioterrorist
attack? Congress needs to enact a ``no fault'' mechanism that could be
modeled after the VICP. It should protect vaccine manufacturers and
health care providers from lawsuits due to potential side effects of
the vaccine and compensate children and adults injured directly or
indirectly by vaccines that are recommended to prevent bioterrorism-
inflicted disease. While the VICP does need to be modernized and
strengthened, any program to address immunizations given in response to
a bioterrorist attack should be a system separate from the VICP. The
program needs to have the following components:
(1) Protection of the vaccine manufacturer against lawsuits should
be absolute except in the case of gross negligence (e.g., failure to
follow good manufacturing procedures during the production and
distribution of the vaccine).
(2) Health care workers and medical facilities participating in the
immunization program need complete protection against lawsuits unless
they violate standard medical procedures when administering the vaccine
(e.g., failure to change needles when withdrawing vaccine from a
multidose vial).
(3) Those who develop a complication due to the vaccine should be
reimbursed for their medical costs and lost earnings, but should not
receive punitive damages.
While I have focused my remarks today on the use of vaccines in a
bioterrorist attack, many of the same liability and compensation issues
would arise during any widespread public health emergency due to an
infectious disease such as will occur the next time there is a pandemic
influenza season. Although the liability and compensation issues raised
by a widespread public health emergency due to an infectious agent are
multiple and complex, the overall goal is simple. The ability to make
the necessary vaccines, administer them to a large number of people and
have a public willing to be immunized are three events that must occur
in consecutive order to minimize the impact of this type of event.
Similar liability and compensation issues will occur if
experimental drugs are used to treat patients infected with microbial
agent. For example, currently there is no FDA-approved drug to treat
smallpox, although several antiviral agents are under development. In
the event of a smallpox bioterrorist attack, one or more of these drugs
might need to be used in an attempt to decrease mortality. The
liability and compensation recommendations I have just discussed for
vaccines would also apply for antimicrobial agents.
I urge Congress to thoughtfully, yet quickly, address the need to
develop a compensation program to deal with the specific issues raised
by a bioterrorist attack. It is critical to minimizing the impact of
such an attack on the public health.
Senator Burr. Dr. Epstein.
Mr. Epstein. Thank you, Mr. Chairman. Mr. Chairman, I am
Gerald Epstein, a Senior Fellow for Science and Security at the
Center for Strategic and International Studies. I have been
looking at issues of science, technology and security for my
entire career which I cannot resist pointing out I began when I
worked for this body. I was initially an analyst at the
Congressional Office of Technology Assessment, which is a
capability that no longer exists today, but I think it is one
that you and the rest of the members of this body and the other
would find very useful at precisely the kind of question that
we are looking at today.
I would like to spend some time this morning discussing
some overall aspects of the bioterrorism threat, what these
characteristics imply for our ability to counter these threats,
some of the high priority actions that we need to take as a
result, and then I want to conclude with a few overall cautions
that we have to keep in mind as we think our way through.
Clearly, this is not a hearing all about the threat, and
the members of this committee are quite familiar with it. But
as we know, history is a very poor guide. We have, I know, few
areas with as great a gulf between a demonstrated proven
capability to do tremendous damage, on the one hand, and a
relative paucity of actual examples of significant human
casualties on the other.
We know that major State programs almost 50 years ago have
demonstrated the capability that the technologies and equipment
available can do tremendous damage. We know that in the
intervening 5 decades that the technology, materials and
expertise from which this ability arises is propagating around
the world and sufficiently motivated terrorists can avail
themselves of the ability to produce these weapons.
We also know now something we may not have known more than
5 or 10 years ago, that terrorists do exist who want to kill
vast numbers of us. So what we do not know is why they have not
applied this capability to that desire. There is a whole other
debate which I will not go into, but it may be just that these
technologies have been unfamiliar to the people who have tried
to commit these acts.
Maybe the generation of terrorists we face today have not
taken high school biology. Next generation of terrorists will
and tomorrow's high school biology classes will be much more
potent than what is available in classes today.
So the capabilities that we are worried about are not only
around today, but if one looks at how technology is evolving,
the dissemination around the world, its availability to people,
the endemic nature in which it is building itself into the
economy, means that more and more capability is going to be in
the hands of more and more people. I think one debate we
sometimes get into is not particularly helpful: here is a given
level of capability that terrorists have today and this is what
they need to do a major biological attack; how close or how far
are we? That is an important question if I want to worry about
what is my chance of being attacked today.
But the questions in front of this committee involve
preparations that will take many years to put in place. We have
to look down the road, not what today's threat is going to be,
but what the threat is going to be years out when the systems
that we are talking about and voting funds for today are put
into place. So no matter what that gap may be right now, it is
going to be smaller next year and smaller the year after that,
and eventually we just have to assume that the capabilities
will be available.
So what does this tell us about the nature of the future
threat? First of all, it is unpredictable in detail. We know,
and I appreciate Senator Roberts' interest in particular--he
has a very hard job with the intelligence oversight and the
intelligence agencies--the amount of effort one needs, the
footprint, as it has been referred to, for producing biological
weapons can be very small. Maybe even harder, the natural
background of legitimate biotechnology activity all over the
world is large and is increasing. So we are looking for a very
small signal in a very large background. It is going to be very
difficult to find these activities.
Second major aspect is that while our defensive efforts
take some time to put into motion, particularly when we are
talking about drugs and therapeutics and approval, the
activities of those developing weapons can be much more
flexible and much more rapid. So these all say that we are not
going to be able to rely on intelligence to give us firm
details about the problem we are worried about.
We are not going to be able to say these are the lists of
bugs we know people are going to work on. These are the ones we
know are the problems. We can say there are some agents that
are more serious than others. And those are the ones that we
are working on today.
But looking out into the future, we are not going to be
able to pick off one by one by one. We have to prepare a broad
response and a rapid flexible biodefense capability if for no
other reason than the threat we may face in 10 years does not
exist today. The groups that are going to be posing that threat
may not have formed so we are not going to be able to steer
directly our efforts based on hard, firm intelligence. We have
to develop broad capabilities.
This then goes directly to the question of some
therapeutics, anti-infectives, antibiotics, and antivirals. If
we do not know exactly what agents we may be forced to
confront, we want mechanisms that can provide broad protection.
It would not matter so much. We do not want a bug-specific
drug. We want something that can address a wide variety of
threats.
This also has direct applicability to another problem. We
spent some time talking today about the public health questions
which are apart from biodefense. We have a serious problem with
microbes becoming resistant to our existing arsenal of
antibiotics and antiviral drugs. If we are able to develop
broad spectrum therapeutics to anticipate future bioterrorism
threats, these are also very important developments we were
going to need just to handle conventional health threats.
We have had a report, if I may be so bold as to bring up
your counterparts across the water, the British House of Lords,
say we may be approaching a pre-antibiotic era. Antibiotic
resistance threatens mankind with a prospect of referring to
the pre-antibiotic era if these diseases continue to evade the
therapeutics we have. We need to do research for that reason
alone.
In order to get this broad flexible responsive biodefense
capability, we need a lot of research infrastructure. Part of
that is the laboratories and the science base that Dr. Fauci
described before. A lot of it is tools, methods, assays,
reagents, a whole supporting industry of tools and capabilities
that are going to make our research in the future better able
to be rapidly responsive.
And this is a capability that does not fit directly under
Bioshield. We are not going to say we are going to buy one
product to provide that capability. That is the kind of
capability that is going to come when there is an industry that
is developed in response to the demand that we are putting on
the mission of getting a more flexible biodefense.
So in terms of the programs we have in place, the NIH
programs are very, very important. A basic science base is
absolutely important. The Bioshield I investments showing that
we need to make connections and provide incentives to industry
are also very important. But I think neither of those is
sufficient by itself, and we have heard already on this panel
some important gaps in that package, one on very important
liability concerns: if a firm has a capability but is not
willing to bet its future survival on the fact that it may not
have been able to anticipate some of the rare side-effects.
Particularly recognizing that in the case of a therapeutic
or vaccine against a bioterror event, we are developing that
product for a situation we really cannot even anticipate today.
We do not know what the future bioterrorist event is going to
look like so I think liability concerns are even more pressing
for biodefense products than we already have in terms of other
products.
And we have also had the question of how much incentive is
enough for industry, and I guess I would just have to argue,
not running a biotech or a pharmaceutical company myself, I am
not quite sure what that level is. But I think there is a
legitimate concern that the existing incentives may not be
sufficient. I am reluctant to raise this story, an anecdote. I
am reminded about an argument my parents once had, and I
believe they will probably read this in the transcript so I
have to watch it. But my mother once said that she really liked
Robert Redford in a movie and my dad said no, she did not. It
was not that he knew what she liked better than she did, but to
his defense, I think he is recalling that she may have said
something at the time.
But the point is it does not matter what I think as a
sufficient incentive for industry. What matters is what
industry thinks is a sufficient incentive, and I think we have
also heard about some of the difficulties of having these
conversations in a group. I believe there may be some legal
mechanisms that under the Defense Production Act or some other
means where we can actually hold some. I know the Commerce
Department has industry advisory committees where they are able
to provide useful collective advice under a Federal Advisory
Committee process. So that is an important mechanism I think we
should pursue.
Let me just go into some of the overall cautions I want to
leave you with before I conclude. One is the other question we
have already touched on today, which I think is a very
difficult one for a public policy, the degree to which the
things we need to develop in the future are restricted to
government biodefense missions or the degree to which they may
actually benefit a commercial or a private or a public health
aspect as well.
In looking for a broad flexible responsive biodefense
research base, I think the things we are going to have to build
for that are not going to be labeled ``government only.'' They
are not going to be labeled ``biodefense only.'' They are going
to have to be broad and capable measures, assays, screening
tools, licenses that are going to be of benefit to everybody,
to the industry as a whole, and I think rather than worry about
that and say that is a fault of the provision, I think that is
something we need to actually embrace if we want to build a
partnership between government and industry and if we want to
have an industry that is able to be responsive.
The initial draft of the Bioshield legislation did provide
that products with commercial utility were not eligible for
Bioshield. That, as I understand, was modified in the last act
and the final bill that passed said generic products would be
available to Bioshield; however, the commercial utility of the
product would be something the Secretary of HHS would have to
consider. So we realize there is a tension here. I think that
tension is going to get worse because the research supporting
capabilities we need are ones that are going to benefit more
broadly, and I think we have to encourage that and not be
afraid of it.
And, finally, I just do want to leave the last reminder
that although we have talked about medical countermeasures
today and they are terribly important, that is just one part of
our overall defense against the bioterrorist threat, and it is
important to address the problem at every stage we can, from
dissuading folks who might go down that road to trying to
frustrate their ability to collect the materials and technology
and expertise. That is a very hard thing to do because the
technology is there, but if we can frustrate that, we want to
work on it, very important aspect of trying to do what we can
to detect these programs wherever they are taking place. And
finally increase our ability to respond after the fact.
I would be happy to answer your questions. Thank you.
Senator Burr. Thank you.
[The prepared statement of Mr. Epstein follows:]
Prepared Statement of Gerald L. Epstein
Mr. Chairman and members of the subcommittee, I appreciate the
opportunity to appear before you today to discuss the capacity to
generate medical countermeasures against biological weapons and
bioterrorism. I am currently serving as Senior Fellow in Science and
Security in the Homeland Security Program at the Center for Strategic
and International Studies here in Washington. I also teach a course on
science, technology and homeland security in the Security Studies
Program at Georgetown University's Edmund A. Walsh School of Foreign
Service. I have been working in the area of science, technology, and
security policy for more than 20 years and have been studying
biological weapons issues and responses for nearly 15 years.
At CSIS, my colleagues and I are launching a major international
effort, supported by the Carnegie Corporation of New York and the John
D. and Catherine T. MacArthur Foundation, to look broadly at biological
weapons threats and to identify opportunities to counter them at all
stages, from influencing the intent to produce weapons, to denying
access to materials and expertise, to detecting illicit programs, to
managing the consequences of an attack. We are also looking at
perceptions and threat reduction activities across Nations and across
professional communities. The activities to be addressed at today's
hearing are an important part of the United States'--and the world's--
response to biological weapons threats.
At CSIS I also organized a workshop to examine the global evolution
of dual-use biotechnology, looking specifically at the implications of
this evolution for the spread of biological weapons and bioterrorism
capabilities. The report for this workshop is in press.\1\
---------------------------------------------------------------------------
\1\ Gerald L. Epstein, Global Evolution of Dual-Use Biotechnology:
A Report of the Project on Technology Futures and Global Power, Wealth,
and Conflict (Washington, DC: Center for Strategic and International
Studies, in press).
---------------------------------------------------------------------------
I'd like to spend some time this morning discussing aspects of the
bioterrorism threat, what they imply for our ability to counter them,
and some high priority actions we need to take as a result. Let me set
out the following points:
(1) Bioterrorism is a very serious threat, but the details of
future biological weapons cannot be known today. Although certain
diseases currently pose more serious terrorist threats than others, a
wide variety of agents might nevertheless be used, and the exponential
growth and dissemination of biotechnology will foster the creation of
new ones. Since the time to develop and produce bioweapons agents is,
in general, much shorter than the time to develop, license, and produce
a response, we cannot rely on hard intelligence alone to direct the
development of countermeasures.
(2) Uncertainties about the future threat put a premium on breadth
of capability and speed of response. Looking ahead, the most important
medical countermeasures are new ``broad spectrum'' antibiotic and
antiviral drugs and other post-exposure therapies. Traditional vaccines
have only a limited role in civilian biodefense, because of the time
they need to develop protection; we cannot vaccinate our way out of
this problem.
(3) Substantially increased NIH biodefense research and the new
Bioshield program are necessary components of our national response,
but they are insufficient. Further incentives are needed to stimulate
production of post-exposure therapeutics and rapid response
capabilities, for which we need new research tools and methods. We also
need to develop animal models for human disease and increased animal
production and testing capacity.
(4) Successful incentives that foster biodefense missions could
benefit commercial enterprise as well, because many of the necessary
supporting capabilities are inherently generic. Policies that attempt
to ensure that government incentives or investments apply only to
government biodefense missions--as the original version of the first
Bioshield legislation attempted to do--are guaranteed to fail at
fostering a dynamic, responsive, and flexible biodefense response
capability.
(5) Medical countermeasures are very important, but they are only
one component of a comprehensive biodefense strategy. Countering
bioterrorism also requires efforts to dissuade, frustrate, detect, and
counter bioterrorism programs at every possible stage of their planning
and execution, not just after an attack has been conducted.
characteristics of the bioterrorist threat
Importance of Taking the Threat Seriously. As members of this
subcommittee no doubt know, history is a poor guide to the bioterrorist
threat. There are few areas with so great a gulf between the proven,
historical capability to do grievous harm, and the relative paucity of
actual attacks. We know for sure that biological weapons, when prepared
for effective dissemination in large enough quantities, can kill over
large areas. All the necessary capabilities to place many thousands of
lives at risk were demonstrated decades ago. We know that the
technology, materials, and expertise required to produce biological
weapons are available to those terrorists who are sufficiently
motivated and skilled to pursue them; essentially all the equipment,
materials, and expertise have legitimate application or can be found
without great difficulty.
And we know that enemies exist who are eager to kill Americans in
vast quantities. What we are not sure of is why we have not yet been
attacked in this way. Maybe not enough of today's terrorists took high
school biology. Tomorrow's will--and their high school biology classes
will be much more potent than today's. We cannot bet our country that
whatever restraints have kept terrorists from pursuing this path will
persist indefinitely.
Exactly how close terrorist groups are right now to the capability
to conduct a major biological attack matters if we want to know how
likely it is that such an attack will take place in the near future.
However, looking out over the several years that our defensive
preparations will take to implement, the details of today's threat are
less important than the realization that the rapidly increasing
capability, market penetration, and geographic dissemination of
relevant biotechnical disciplines will inevitably bring weapons
capabilities within the reach of those who may wish to use them for
harm (see figure 1).
Difficulty in Predicting or Specifying Future Threats. Given the
diversity of potential biological weapon agents and the increasing
ability to modify or augment them, either through conventional
techniques or genetic engineering, we will never be able to restrict
our efforts to a short list of agents considered to be the most serious
threats. It is true that certain agents today are considered to pose
greater terrorist risks than others because of their combination of
health consequences and ease of dissemination. Moreover, a few
diseases, such as smallpox and anthrax, pose such dangers that they are
worth special attention (smallpox because of its lethality and
contagiousness; anthrax because of its lethality and hardiness).
However, a wide variety of agents could be used as weapons, and that
list will grow over time as science advances, biotechnology spreads,
and new capabilities become feasible.
Intelligence collection efforts will not provide a reliable guide
for our biodefense activities. First, the ``signatures,'' or observable
signs, of a terrorist bioweapons development activity will be very
difficult to detect, particularly amidst a large and rapidly growing
background of legitimate biotechnical activities. Bioweapons programs
do not require large, expensive, or distinct facilities, and we cannot
have much confidence that we will spot them.
More serious is the significant mismatch in time scales between
attackers and defenders. Unless we radically transform the way we do
business--a scientific and technical challenge as much as a management
or resource one--our programs to design, develop, approve, and produce
medical countermeasures will have lead times that are much longer than
those of the terrorist weapons programs they are intended to counter.
Today's defensive programs cannot be designed against today's threat
but rather must anticipate the threat years in the future--posed by
groups and programs that may not even exist today. Moreover, we are
unlikely to be able to mount major countermeasures development programs
covertly. Attackers will probably know what countermeasures we are
developing and if possible, will work to evade them.
implications for biodefense
Role of Vaccines. Unavoidable uncertainties in the future
biological threat place a premium on broad-spectrum, post-exposure
therapeutics and rapid reaction capabilities. Traditional vaccines are
less relevant, since they are only effective against specific diseases
(and often only against specific strains), and because they generally
generate immunity too slowly to be of much value if given after the
fact. (Smallpox and anthrax vaccines are exceptions, because they have
therapeutic value even if given after exposure). Too many possible
other disease threats exist for us to vaccinate our way out of the
bioterrorism problem. And we are very unlikely as a society to decide
to vaccinate large groups against potential bioterror agents in advance
of any attack, since we would not be able to justify imposing the small
but nonzero risk of vaccination when we have absolutely no way of
knowing what harm--if any--those vaccines will have avoided.
Novel vaccine approaches--such as so-called ``DNA vaccines''--are
very important because they offer the tantalizing prospect of mounting
an immune response fast enough to have therapeutic value post-exposure.
However, such vaccines are too speculative to be able to anticipate
successful products, or to fit within the 8-year window needed to
qualify for Bioshield I funding. Vaccine research might also lead to
the development of antibodies to provide quick but temporary protection
against a disease during the time needed for a more conventional
vaccine to take effect. Even though these techniques would--if
successful--provide some ``post exposure'' response capability, they
would still be very specific towards particular diseases.
Need for Additional Antivirals and Antibiotics. Since traditional
vaccines are of limited value in responding to an attack, we need
antibiotics and antiviral drugs. However, despite their importance for
dealing with natural disease outbreaks, let alone bioterror attacks,
the development of such anti-infective has been neglected by the
pharmaceutical industry in favor of drugs to treat chronic conditions,
such as hypertension, cancer, and heart disease. These conditions
provide large and continuing markets, whereas most infectious diseases
occur only sporadically, particularly in the developed world markets
that can readily afford pharmaceutical products. The required course of
anti-infective treatment lasts only a week or two, and if successful it
clears up the problem--and eliminates the need for further business.
Pharmaceutical manufacturers would rather devote their resources to
drugs with larger and more lucrative markets--and they would be
punished by their investors if they didn't. (As a public policy
researcher, I would love to be able to focus my attention on policy
problems without considering the financial consequences--but if I am
not able to convince a funder to support my expenses and those of my
institution, I'm not going to be in a position to work on that topic
for long).
A 2004 paper by UCLA researchers finds that, out of 506 new drug
candidates that have been disclosed in the development programs of the
largest pharmaceutical and biotechnology firms, only 31 represented
anti-infectives: 6 antibiotics; 12 antiviral drugs to combat HIV; 5
other antivirals; 5 drugs to combat parasites; 5 to combat fungi; and 1
other.\2\
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\2\ Brad Spellberg, John H. Powers, Eric P. Brass, Loren G. Miller,
and John E. Edwards, Jr., ``Trends in Antimicrobial Drug Development:
Implications for the Future,'' Clinical Infectious Disease 2004:38:
1279-86.
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This dearth of new anti-infectives in the pipeline is especially
troubling given the rate at which naturally occurring pathogens are
evolving resistance to existing antibiotics and antiviral drugs.
The Infectious Disease Society of America points out that
infections that were once easily treatable are becoming ``difficult,
even impossible, to treat'' today. More than 70 percent of the bacteria
causing hospital-acquired infections are resistant to at least one of
the drugs typically used to combat them. Resistance to multiple drugs
is increasing, including resistance to vancomycin, a drug of ``last
resort.'' Only two new classes of antibiotic have been developed in the
last 30 years, where a class represents those drugs that all utilize
the same mechanism to kill bacteria or viruses--and that are all
subject to losing their effectiveness as soon as pathogens evolve the
ability to evade that mechanism.\3\
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\3\ Quotations and statistics in this paragraph from The Infectious
Disease Society of America, Bad Bugs, No Drugs: As Antibiotic Discovery
Stagnates . . . A Public Health Crisis Brews, July 2004 available
online at (http://www.idsociety.org/pa/IDSA Paper4 final web.pdf)
accessed February 6, 2005; pp.9,10.
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A 1998 United Kingdom House of Lords report concluded that
``antibiotic resistance threatens mankind with the prospect of a return
to the pre-antibiotic era.'' \4\
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\4\ United Kindom Parliament, House of Lords, Science and
Technology Committee, ``Resistance to Antibiotics and Other
Antimicrobial Agents,'' Seventh Report, March 17, 1998, available
online at (http://www.parliament.the-stationary-office.co.uk/pa/
ld199798/ldselect/ldsctech/081vii/st0703.htm) accessed February 6,
2005; section 1.19.
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Clearly there is a critical need for new antibiotics and antiviral
drugs not only for biodefense, but also to combat naturally occurring
infectious disease.
Need for Research Tools, Methods, and Infrastructure. In the long
run, we need a vibrant, flexible, and responsive biodefense system that
can adapt to threats as they materialize. We cannot mount decade-
length; billion-dollar scale vaccine or drug development programs to
combat every potential threat agent. Therefore, we must develop
research tools that can make a much more responsive system possible.
Building such a system will be a tremendous challenge, and there are
fundamental scientific questions that will need to be resolved.
However, there will certainly be need for tools such as assays for
rapidly screening drug candidates; improved methods for determining
chemical and biological properties of drug candidates that can
accelerate and/or replace certain stages of preclinical testing;
bioinformatics approaches to identify promising drug targets; and a
wealth of other approaches, including many that are undoubtedly yet to
be envisioned.
A major component of this research infrastructure will be improved
animal facilities and understanding. Given that many diseases of
bioterror concern occur too rarely in humans to permit clinical trials,
the Food and Drug Administration has specified that efficacy testing of
drugs can be conducted in two different species of animals, rather than
humans. However, the ``animal models'' utilized in these tests must be
sufficiently well understood so that the drug's effect on the disease
in those animals can be reliably related to how that drug would work
against human disease. Development of these animal models; as well as
the construction of animal facilities in which these animals can be
bred and these tests can be conducted, is a critical biodefense need.
Right now, shortages of animals, animal facilities, and animal models
threaten to limit and constrain research.
existing government r&d programs and incentives for industry are
necessary, but not sufficient
The Role of the National Institutes of Health. Substantially
increased NIH biodefense research funding and the Bioshield program
that was enacted last year are necessary components of our national
response, but they are not sufficient to generate these post-exposure
therapeutics and other essential components of a response to
bioterrorism. Important parts of the problem remain unaddressed, such
as the research tools and animal model issues described above.
Scientific investments made by NIH have driven the growth of the
biotechnology industry over the last few decades, and the very
substantial ($1.7 billion) increase in the level of annual NIH funding
for biodefense research will improve our basic understanding of disease
pathogenesis as well as lay the groundwork for the development of drug
and vaccine countermeasures. These investments are also funding
substantial increases in ``high containment'' research facilities that
allow scientists to work with dangerous organisms safely. In its
traditional role of pursuing the most exciting and productive
biomedical science, leaving industry to pick up and run with what it
wants, NIH has been tremendously productive. However, this largely
``bottom-up'' approach is less well suited for a more mission-oriented,
product-focused program to filling specific biodefense needs that
involve product design and development, clinical trials, FDA approval,
scaleup, and manufacturing. Industry's involvement in this process is
critical.
NIH research investments will also be essential for bolstering the
scientific underpinnings for improved research tools and methods. NIH
has developed guidelines that are intended to ensure that research
tools, materials, and other resources developed in the course of NIH
sponsored research become available to other investigators. However, it
is not clear that these guidelines are optimally designed to achieve
that end, particularly on the scale that will be needed to support a
robust, responsive biodefense capability. The working group that
developed those guidelines found that ``intellectual property
restrictions can stifle the broad dissemination of new discoveries and
limit future avenues of research and product development.'' \5\
---------------------------------------------------------------------------
\5\ Federal Register, vol.64, no. 100 (May 25, 1999), p. 28206.
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Although the group also found that ``reasonable restrictions on the
dissemination of research tools are sometimes necessary to protect
legitimate proprietary interests and to preserve incentives for
commercial development,'' \6\ the resulting guidelines do not appear to
give sufficient emphasis to the role that commercial firms play in
improving, standardizing, distributing, and marketing these tools--and
to the corresponding ability that these firm must have to control the
distribution of the resulting materials and recoup their investment. I
hope that other witnesses at this hearing can provide further
information on incentives that NIH and others can offer that will best
facilitate the development and dissemination of research tools.
---------------------------------------------------------------------------
\6\ Ibid.
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The Role of the Pharmaceutical/Biotech Industry. Pharmaceutical and
biotech firms, on the other hand, have not in the past had much
incentive to develop products for what are essentially government
biodefense markets. Debate leading up to the passage of the original
Bioshield legislation last year recognized the importance of engaging
these firms, the barriers that had prevented them from participating,
and the need to develop new incentives to engage them. Indeed, Congress
has appropriated $5.6 billion dollars as of fiscal year 2004 to fund
Bioshield purchases, and procurements using these new authorities are
now underway. However, it is not clear that these existing incentives
will be sufficient, for example, to motivate firms to increase their
development of anti-infectives. Given how important it is to augment
our existing antibiotic and antiviral arsenal for public health
purposes as well as for biodefense, government incentives to stimulate
their development--even ones that are not immediately applicable to
biodefense--would be appropriate.
The original Bioshield legislation also left gaps, such as the
failure to provide liability protection for firms that develop medical
countermeasures in good faith the best available scientific and
technical understanding notwithstanding, no vendor preparing products
to mitigate the consequences of a terrorist attack can ever fully
predict the circumstances under which those products would be used, let
alone conduct fully realistic tests or evaluations. It will therefore
be important to assure firms who are otherwise willing and able to
produce medical countermeasures that the threat of product liability
lawsuits will not put their survival at risk. An Institute of Medicine
Committee that examined DOD's program to develop medical
countermeasures against biological warfare agents concluded that ``it
is important for the government to address industry concerns about
product liability risks as part of efforts to accelerate the
development of medical biodefense countermeasures.'' \7\
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\7\ Committee on Accelerating the Research, Development, and
Acquisition of Medical Countermeasures Against Biological Warfare
Agents, Giving Full Measure to Countermeasures: Addressing Problems in
the DOD Program to Develop Medical Countermeasures Against Biological
Warfare Agents, Lois M. Joellenbeck, Jane S. Durch, Leslie Z. Benet,
eds., (Washington, DC: National Academies Press, 2004), p. 80 available
online at (http://books.nap.edu/books/0309091535/html/80.html#pagetop)
accessed February 6, 2005.
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The SAFETY Act (part of the Homeland Security Act, Public Law 107-
296) does provide some liability protection to manufacturers of
products to counter terrorist attacks, but it does not apply to
products used in anticipation of such an attack, as many medical
products might be. Nor does it provide compensation for those who may
have been harmed by an antiterrorism product. Therefore, if liability
protection is to be provided to shield vendors from unwarranted
liability claims, some mechanism going beyond the SAFETY Act--and
preferably one that provides compensation for legitimate claims--must
be provided.
inadvisability of drawing strict boundaries between biodefense and
commercial missions
At an earlier stage of my career, I directed a study that examined
the relationship between military and commercial technologies, looking
in particular at the effects and implications of government policies to
stimulate one or the other.\8\
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\8\ Alic, John A.; Branscomb, Lewis M.; Brooks, Harvey; Carter,
Ashton B., and Epstein, Gerald L.; Beyond Spinoff: Military and
Commercial Technologies in a Changing World (Boston, MA: Harvard
Business School Press, 1992).
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It was clear at the time--and it remains true today--that
government policies that have the intent--or the effect--of stimulating
commercial technology development can be quite controversial.
Legitimate objections would be raised to policies that would put
government in the position of ``Picking Winners and Losers,'' with the
argument being made that the marketplace was much more appropriate than
the government in making such a determination. Interestingly, I think
that ``picking winners'' was often a bigger problem than ``picking
losers.'' The latter merely wasted money, whereby the former took
resources from all of us and had the effect of applying them to the
benefit of just a few. Even when such actions were well justified on
the basis of their public benefit, the fact that there were private
beneficiaries raised issues of equity and fairness.
I revisit this debate because I fear that similar concerns could
cripple our efforts to generate a vibrant, responsive, and effective
biodefense capability. Some of the most important requirements we
face--improved research infrastructure; new tools and methods; new
antiviral and antibiotic products; new animal models and facilities--
are not specific to biodefense; they apply to biodefense and to
commercial missions alike. If we are too concerned about ``picking
winners''--if we avoid taking actions that might benefit commercial
firms, even as they support the biodefense mission--we are guaranteed
to fail at developing the capabilities we need. The original Bioshield
legislation attempted to do just that, making any product that had a
nonbiodefense application ineligible for Bioshield support. Congress
wisely eliminated that prohibition before enacting that legislation.
Future actions to support our biodefense capability are similarly
bound to raise this same question. Given how generically applicable the
necessary capabilities are, we must embrace, rather than avoid, these
``dual-use'' benefits. Clearly, careful attention will have to be paid
to the details in any such incentive scheme to ensure that they are not
abused by firms that are not contributing to the biodefense mission, or
that are taking advantage of loopholes in the procedures to enrich
themselves at the public's expense. But if firms acting in good faith
to support the Nation's biodefense mission are unable to benefit in
their commercial activities, we are not doing what we need to be doing.
need for a comprehensive approach
Finally, although my comments today have been directed primarily at
medical countermeasures to bioterrorist attack, it is important to
recognize that we cannot rely solely on after-the-fact responses in
dealing with the threat of bioterrorism. As important as they are,
medical countermeasures are only one component of a comprehensive
biodefense strategy. We must put programs in place to dissuade,
frustrate, detect, and counter bioterrorism programs at every possible
stage, not just after an attack has already taken place.
One of the chief difficulties in fighting bioterrorism is that none
of the measures we can imagine, by itself, can offer high confidence in
successfully countering this threat. But by putting a combination of
measures in place, or a layered defense--recognizing that each measure
or layer has limitations and weaknesses--we can maximize our chances of
success.
other useful references
Bradley T. Smith, Thomas V. Inglesby, Tara O'Toole, ``Biodefense
R&D: Anticipating Future Threats, Establishing a Strategic
Environment,'' Biosecurity and Bioterrorism, Vol. 1, No. 3: September
2003, pp. 193-202.
Lynne Gilfillan, Bradley T. Smith, Thomas V. Inglesby, Krishna
Kodukula, Ari Schuler, Mark Lister, and Tara O'Toole, ``Taking the
Measure of Countermeasures: Leaders' Views on the Nation's Capacity to
Develop Biodefense Countermeasures,'' Biosecurity and Bioterrorism,
Vol. 2, No. 4: September 2003, pp. 320-327.
FIGURE 1: Implications of Technology Advance for Bioterrorism
No matter what the actual gap is today between a terrorist group's
level of capability in biological weapons and the level needed to do
substantial harm, that gap will disappear over time.
one-page summary
(1) Bioterrorism is a very serious threat, but the details of
future biological weapons cannot be known today. Although certain
diseases currently pose more serious terrorist threats than others, a
wide variety of agents might nevertheless be used, and the exponential
growth and dissemination of biotechnology will foster the creation of
new ones. Since the time to develop and produce bioweapons agents is,
in general, much shorter than the time to develop, license, and produce
a response, we cannot rely on hard intelligence alone to direct the
development of countermeasures.
(2) Uncertainties about the future threat put a premium on breadth
of capability and speed of response. Looking ahead, the most important
medical countermeasures are new ``broad spectrum'' antibiotic and
antiviral drugs and other post-exposure therapies. Traditional vaccines
have only a limited role in civilian biodefense, because of the time
they need to develop protection; we cannot vaccinate our way out of
this problem with single-disease-specific remedies.
(3) Substantially increased NIH biodefense research and the new
Bioshield program are necessary components of our national response,
but they are insufficient. Further incentives are needed to stimulate
production of post-exposure therapeutics and rapid response
capabilities, for which we need new research tools and methods. We also
need to develop animal models for human disease and increased animal
production and testing capacity.
(4) Successful incentives that foster biodefense missions could
benefit commercial enterprise as well, because many of the necessary
supporting capabilities are inherently generic. Policies that attempt
to ensure that government incentives or investments apply only to
government biodefense missions--as the original version of the first
Bioshield legislation attempted to do--are guaranteed to fail at
fostering a dynamic, responsive, and flexible biodefense response
capability.
(5) Medical countermeasures are very important, but they are only
one component of a comprehensive biodefense strategy. Countering
bioterrorism also requires efforts to dissuade, frustrate, detect, and
counter bioterrorism programs at every possible stage of their planning
and execution not just after an attack has been conducted.
Senator Burr. The chair will recognize Mr. Cameron.
Mr. Cameron. Mr. Chairman, members of the Bioterrorism and
Public Health Preparedness Subcommittee, I am honored to be
testifying before you today on the issue of scientific progress
in developing bioterror countermeasures. I am Gordon Cameron,
Chief Executive Officer of Acambis. Acambis is a leading
developer and producer of vaccines to prevent and treat
infectious disease. We employ around 280 people, predominantly
in Cambridge and Canton, Massachusetts, although we also have
operations in Miami, Florida and Cambridge, UK.
Before I begin, I would like to acknowledge the dedication
of the members of this subcommittee to the improvement of
current U.S. biodefense preparedness capabilities. In
particular, I would like to thank Acambis' constituent senator,
the Honorable Edward Kennedy, for his continued support of our
smallpox vaccine programs and for his leadership in introducing
Project Bioshield together with Senator Gregg. Chairman Burr,
we value your leadership on smallpox vaccine compensation so
that first responders would be encouraged to be vaccinated
against smallpox. It is with your dedicated leadership, we can
ensure the United States and the world can be shielded from the
ever-present threat of bioterrorism.
As members of the subcommittee are aware, Acambis'
involvement in biodefense has been in the area of smallpox.
Under contracts with the Centers for Disease Control, Acambis
developed ACAM2000, a new smallpox vaccine with our partner,
Baxter Bioscience Vaccines, manufactured over 180 million doses
which have been delivered in complete vaccination kits to the
Strategic National Stockpile. Extensive clinical trials have
been conducted of the vaccine. Acambis has also supplied
ACAM2000 to a number of foreign countries also to be used for
emergency use stockpiles.
In addition, Acambis and Baxter are developing a weakened
smallpox vaccine under contract with the NIH known as MVA. This
vaccine is intended for vaccination of the many individuals
with skin diseases and compromised immune systems who have
contraindications for the use of standard smallpox vaccine.
Acambis is a real-life case study of biodefense policy in
action. I thought it would be useful, therefore, to draw upon
some lessons learned from Acambis' experience. On the positive
side, ACAM2000, that project and that contract have undoubtedly
been a major success. Since we were awarded that contract at
the end of 2001, we have developed a new vaccine and tested in
clinical trials in over 4,000 subjects, both Phase I and Phase
II and Phase III clinical trials, and we expect to file a
product license application this year.
In addition, we have delivered over 180 million doses to
the Strategic National Stockpile. So I think this contract and
our performance on it is virtually unprecedented in terms of
both scale and in terms of the pace of development and
production that took place. As Senator Kennedy pointed out, it
was on time and on budget.
So whenever these kind of things happen, we always need to
analyze what were the critical success factors in making it
happen. I think in the first instance, we had excellent
partnership with the U.S. Government and the various agencies.
In particular, I would highlight the cooperation we received
from the FDA where, unlike a typical periodic review type
process of the FDA course of action, we were getting real-time
assistance and real-time cooperation, almost daily contact with
the FDA, so as issues surfaced, whether they be in the clinical
trial design or whether they be in the manufacturing process,
we were able to resolve them almost immediately.
Second, in terms of the contractual piece of the contract,
we had a very flexible approach to funding in the way the
contract was designed. We would get our funded research and
development payments on a monthly basis, and that enabled us to
in part offset the inherent risk in a development program, but
also actually provided some working capital for the large-scale
production that was taking place alongside the research and
development.
In addition, a technical point of view, the contract
permitted fixed price subcontract arrangements with our
subcontractors, and through that arrangement, we were able to
then draw upon the expertise and capability of our primary
subcontractor, Baxter Health Care Corporation, for whom without
a fixed price arrangement would not have participated.
In addition, the way the contract was set up, the
government actually procured and paid us for product as we
delivered it into the stockpile, irrespective of the fact that
it was not actually yet licensed. And that was clearly, you
know, advantageous to us, both in terms of cash flow, both in
terms of delivering on the final contract.
So I have highlighted some positives and what I would also
then do is maybe highlight possible areas for improvement or
reflection. We believe, in the first instance, that the final
product procurement should be at a level that is consistent
with either the original or previously stated goals or
policies, and I would cite three examples in this regard: with
ACAM2000, there was an intended policy at one point in time to
procure 209 million doses of the vaccine, and yet when the
final contracts were drawn up, only 182 million doses of the
vaccine were ordered. We believe this is in part due to
budgetary issues, but the point being that the decision was
made relatively late in the day after such time as Acambis had
already incurred the cost and the effort to actually work
toward the 209 million dose requirement.
Partly related to that is a second issue whereby the first
generation vaccine, which many of you are aware was
manufactured decades ago on the bellies of calves through a
process that would not be acceptable to the FDA today, that
vaccine in itself makes up a significant proportion of the
smallpox vaccine stockpiled today. And we had previously
understood or been led to believe that the old vaccine was
being used as a short-term insurance policy until such time as
the ACAM2000 product was available.
Over time that policy appears to have changed. ACAM2000
vaccine is now available. However, the first generation vaccine
now appears to be a core part of the policy in the stockpile.
Granted that it is still effective, but I think in the context
of having differentiated products sitting in the stockpile,
some unlicensed or unlicensable and some product that is about
to be licensed, I think that provides some perception issues
for the government.
The third aspect of this we would highlight, on MVA,
Project Bioshield and other documentation supporting Project
Bioshield has highlighted the need to procure up to 60 million
doses of MVA vaccine, but until such time as the RFP comes out
for the third contract, we still are not aware of how many
doses will actually be procured.
In each of the above three cases, the element of
uncertainty has been introduced into the process and actual or
potential financial loss has also been introduced. Both of
these issues make industry wary and does not help in the
government's stringent efforts to try and encourage industry to
participate in the biodefense initiative.
The second area of improvement I would highlight would be
in terms of the long-term manufacturing arrangements. This is
not just about acquiring a stockpile. It is about acquiring a
capability over a longer period of time. Very few companies
will be interested in putting in all the infrastructure
required simply to provide a short-term stockpile and get a
short-term return.
All companies are going to be interested over the longer
term. So we have discussed over the last several months and
years, in fact, with the government the concept of warm-based
manufacturing which essentially is ensuring a state of
readiness in the production process such that should there be a
need to acquire or procure significant additional doses in the
event of an outbreak, then there would be a facility ready and
available to make large quantities of vaccine.
This concept is consistent with what the World Health
Organization outlined recently in its smallpox vaccine
initiative where it declared that it wanted to have at least
two sites around the world capable and ready to produce
smallpox vaccine at short notice. We are clearly one of those
suppliers.
But I think we need to learn from the lessons from the past
here where in the case of smallpox vaccine, production ceased
in the early 1980s because there was no defined market. So
creating the market through a warm-based manufacturing approach
which would essentially involve annual production runs and the
government procuring vaccine on an annualized basis would serve
both parties well. The government would have a state-of-
readiness facility available to it for the company to produce
vaccine. The company would have a longer term revenue
arrangement which in itself would be attractive.
In our case, we are still awaiting confirmation. We have
submitted a proposal to the government for a warm-based
manufacturing proposal over the longer term and we still await
both confirmation and budgetary approval for that particular
process. Each of that adds to this issue of uncertainty for the
contractors that are highlighted above.
Finally, I will just refer to the issue of manufacturing
generally. The topic of this hearing is scientific progress. On
that subject, it is all too easy to focus on the research and
development aspects. Much has already been done to support
innovative research in the area of biodefense. This is only
part of a much larger and much more complex picture if
scientific developments are to bring real benefits. In
particular, I refer to manufacturing.
There is little point in developing a countermeasure if it
cannot be made at the required scale. Incentives should be
applied as much to production as to research and development of
countermeasures. Acambis has been a proud and willing
participant in the biodefense arena to date. However, Acambis'
and other companies' willingness to participate or continued
participation is dependent upon a stable commercial arrangement
for manufacturing and upon government commitment to stockpiling
contracts and production readiness or warm-based programs.
Without these, the scarce and highly valuable resources and
capabilities of companies such as Acambis will be deployed in
other areas that are more commercially attractive, leaving the
government less able to fulfil its stated policy commitments.
Mr. Chairman, members of the subcommittee, I thank you once
again for inviting me to speak today and I am happy to answer
any questions you may have.
Senator Burr. Thank you so much and thank all four of you
for your testimony.
[The prepared statement of Mr. Cameron follows:]
Prepared Statement of Gordon Cameron
testimony summary
Acambis is a leading developer of vaccines to prevent and treat
infectious diseases, employing around 280 people in Cambridge and
Canton, Massachusetts, Miami, Florida and Cambridge U.K.
Under contracts with the Centers for Disease Control, Acambis
developed ACAM2000, a new smallpox vaccine and, with our partner,
Baxter Bioscience Vaccines, manufactured over 180 million doses, which
have been delivered in complete vaccination kits to the Strategic
National Stockpile. In addition, Acambis and Baxter are developing a
weakened smallpox vaccine under contract to the NIH. Designated as MVA,
this vaccine is intended for vaccination of individuals with skin
diseases and compromised immune systems, who have contraindications for
use of standard smallpox vaccine.
The incredibly rapid pace of the vaccine development program for
ACAM2000, which will break all existing records for time to receive FDA
licensure and for the scale of vaccine supply, was in part due to our
unique partnership with the Federal Government. The Federal Government
worked closely with Acambis to minimize risk and drive development from
the laboratory through large-scale manufacturing and clinical trials.
At the same time, our private-public partnership taught Acambis
that government support at the development stage of production, while
contributing to the rapid deployment of ACAM2000 to the Strategic
National Stockpile, was an insufficient precondition for Acambis to
realize the full benefits of our mutual investment with the Federal
Government. What was needed was a stable and commercially viable
funding arrangement for sustainable manufacturing, not just for the
``now'' but to secure supplies for the future. Consequently, our
willingness to develop new countermeasures relies on the availability
of this arrangement.
Lessons learned include: (1) The final dose order should be
consistent with original plans negotiated between the manufacturer and
Federal Government; and (2) The government should provide for a
production readiness arrangement, otherwise referred to as ``warm-based
manufacturing.'' This policy involves continued funding to support a
minimum level of annual production, to strengthen domestic preparedness
for a smallpox emergency, while providing an incentive to build and
maintain a specialized facility for biodefense vaccine production.
It is necessary that manufacturers of biodefense countermeasures
have stable and commercially viable funding arrangements for
manufacturing to ensure continued scientific progress because: (1)
Vaccine manufacturing is associated with tremendous risk and cost.
Without the appropriate incentives for manufacturing, our facilities
and technological know-how will be used for purposes other than
biodefense; and (2) there is an enormous need for scientific progress
with other bioterrorism agents. Because of the benefits of advanced
science, the U.S. Government must encourage innovation of new
production methods such as cell-culture to improve domestic
preparedness for biodefense and infectious disease.
______
Mr. Chairman, members of the Bioterrorism and Public Health
Preparedness Subcommittee, I am honored to be testifying before you
today on the issue of scientific progress in developing bioterror
countermeasures. I am Gordon Cameron, CEO of Acambis. Acambis is a
leading developer of vaccines to prevent and treat infectious diseases,
employing around 280 people in Cambridge and Canton, Massachusetts,
Miami, Florida and Cambridge U.K.
Before I begin, I would like to acknowledge the dedication of the
members of this subcommittee to the improvement of current U.S.
biodefense preparedness capabilities. In particular, I would like to
thank Acambis's constituent Senator, the Honorable Edward Kennedy, for
his continued support of our smallpox vaccine programs, and for his
leadership in introducing Project Bioshield together with Senator
Gregg. Chairman Burr, we value your leadership on smallpox vaccine
compensation, so that first-responders would be encouraged to be
vaccinated for smallpox. Senator Gregg, I would also like to applaud
your introduction of S. 3 along with your colleagues, Senate Majority
Leader Frist and Senators Sessions, DeWine, Santorum, McConnell, DeMint
and Allen. It is with your dedicated leadership that we can ensure the
United States--and the world--can be shielded from the ever-present
threat of bioterrorism.
Mr. Chairman, members of the subcommittee, among all of the
diseases that could be used for bioterrorism, smallpox is widely
acknowledged to be by far the greatest threat. Not only is it a
fearsome disease, killing over one-third of those afflicted, but it is
contagious and if introduced, could spread rapidly across the Nation
and the world. Nearly half the world population has no immunity to
smallpox, since routine vaccination ceased 30 years ago. Two dramatic
table-top exercises, ``Dark Winter'' conducted in June 2000 and the
recently completed ``Atlantic Storm,'' have demonstrated the global
impact of a bioterrorist incident, highlighting the widespread economic
and societal devastation it would provoke around the world. The
eradication of smallpox remains one of the world's greatest medical
achievements, but knowing that the former Soviet Union developed
smallpox as a strategic biological weapon, and fearing that stocks of
the virus could have spread to other former Soviet States or even to
terrorist groups, it is essential that the world prepare against the
possibility of its return.
Currently, vaccines offer the only realistic countermeasure to
smallpox. Under contracts with the Centers for Disease Control, Acambis
developed ACAM2000, a new smallpox vaccine and, with our partner,
Baxter Bioscience Vaccines, manufactured over 180 million doses, which
have been delivered in complete vaccination kits to the Strategic
National Stockpile. Extensive clinical trials have been conducted of
the vaccine. Acambis has also supplied ACAM2000 to a number of foreign
countries for emergency-use stockpiles.
In addition, Acambis and Baxter are developing a weakened smallpox
vaccine under contract to the NIH. Designated as MVA, this vaccine is
intended for vaccination of the many individuals with skin diseases and
compromised immune systems, who have contraindications for use of
standard smallpox vaccine.
Scientific Progress: Cell-Cultured Smallpox Vaccine
Even before the terrorist attacks on September 11, 2001, the CDC
recognized that the U.S. stockpile of smallpox vaccines had to be
augmented and updated. In September 2000, it awarded Acambis a contract
to develop a new smallpox vaccine, and to manufacture and maintain a
stockpile of 40 million doses.
The objective of this contract was to develop a modern equivalent
to the old smallpox vaccines that were used so effectively in the
worldwide eradication program while taking advantage of state-of-the-
art cell-culture manufacturing technology, equipment and processes.
Vaccine manufacture has come a long way since the old vaccines were
produced from the skin of cows. Cell-culture manufacture allows for
production of a 21st century product, consistent with Good
Manufacturing Practices, free from concerns about potential animal-
related contaminants, and capable of being produced more rapidly and in
larger quantities.
The U.S. Government has a clear policy to maintain a stockpile of
smallpox vaccine sufficient to vaccinate every man, woman and child in
case of a smallpox outbreak. The 182.5 million doses of ACAM2000 we
successfully delivered to the Strategic National Stockpile represent
only part of the U.S. stockpile. The balance is comprised of two brands
of animal-derived smallpox vaccines, and we understand that the
government has reserved 20 million doses of these vaccines for use by
World Health Organization in case of an outbreak in a foreign country.
Mr. Chairman, Acambis believes that all citizens should have access
to the most technologically advanced smallpox vaccine available, which
is ACAM2000. Following extensive clinical testing, ACAM2000 will
shortly be reviewed for licensure by the FDA, which has identified it
as a product for fast-track regulatory review. Moreover, we support a
policy that would make this modern cell culture-derived product,
particularly if it is licensed by FDA, available to our friends and
allies through the auspices of WHO, rather than the antiquated cow
skin-derived vaccine.
As members of the subcommittee are well aware, concerns about the
lack of countermeasures extend far beyond known bioterrorism agents and
covers a long list of infectious diseases. Nature has been the most
efficient purveyor of new biological threats, such as pandemic
influenza, SARS and West Nile. I would submit that because of the
benefits of advanced science, the U.S. Government must encourage
innovation of new production methods such as cell-culture to improve
domestic preparedness for biodefense and infectious disease.
Ensuring Continued Scientific Progress of Biodefense Countermeasures
Mr. Chairman, I would like to highlight the incredibly rapid pace
of this vaccine development program, which will break all existing
records for time to receive FDA licensure and for the scale of vaccine
supply. A key element of technical progress was our unique partnership
with the Federal Government. From the beginning, the Department of
Health & Human Services, the CDC, and in particular the FDA's Center
for Biologics Evaluation and Research worked closely with us, thereby
minimizing risk and driving development from the laboratory through
large-scale manufacturing and clinical trials.
Three specific government actions were instrumental in moving our
vaccine development program forward. The first involved a flexible
approach to funding, particularly the form of monthly installments for
research and development funding, which helped to maximize flexibility
and alleviate the myriad of risks associated with accelerated product
development. The second relates to the FDA's willingness to monitor all
aspects of the manufacturing, control, and clinical development on an
ongoing basis instead of upon completion of all studies. With FDA's
real-time assistance and cooperation, Acambis was able to successfully
develop manufacturing plans for ACAM2000. Finally, the willingness of
HHS to view subcontractor relationships as commercial fixed price
efforts allowed Acambis to utilize large healthcare companies--with
proven infrastructure and supply chain capabilities--to perform
important facets of the program.
I can say with all certainty that we would not have a partial U.S.
stockpile of cell-cultured smallpox vaccines without the hard-work and
dedication of our government and partners, particularly during the
critical years following September 11.
At the same time, our private-public partnership taught us that
government support at the development stage of production, while
contributing to the rapid deployment of ACAM2000 to the Strategic
National Stockpile, was an insufficient precondition for Acambis to
realize the full benefits of our mutual investment with the Federal
Government. What was needed was a stable and commercially viable
funding arrangement for sustainable manufacturing, not just for the
``now'' but to secure supplies for the future. Consequently, our
willingness to develop new countermeasures relies on the availability
of this arrangement.
Allow me to provide you with two examples from Acambis' experience
to highlight instances where the funding arrangement for manufacturing
could have been made more stable and commercially viable to encourage
continued scientific progress in biodefense.
First, it is important that the final dose order be consistent with
original plans negotiated between the manufacturer and Federal
Government. In the case of ACAM2000, in initial discussions, the
government had expressed an intention to order 209 million doses for
the U.S. Strategic National Stockpile. In the end, the government
ordered 182.5 million doses, in part, we believe, due to budgetary
constraints. Acambis, as the contractor, had been working towards the
209 million dose goal, so was both surprised and disappointed by the
government's decision. Acambis also suffered financially, as the
investment made, largely in good faith, did not yield the expected
return. This type of a scenario is exactly what dissuades many industry
players from participating in the biodefense business. It is also
unfortunate that it comes at a critical time when government is making
extensive efforts to attract industry to participate in supporting its
Biodefense initiatives.
Second, the government should automatically provide for a
production readiness arrangement, otherwise referred to as ``warm-base
manufacturing.'' This involves continued funding to support a minimum
level of annual production, once the initial stockpile requirements
have been sent to the Strategic National Stockpile. The ACAM2000
contract did not establish funding for a specific program.
From a biodefense standpoint, warm-base aims to strengthen domestic
preparedness for a smallpox emergency. The lead time associated with
reinstating manufacturing for the smallpox vaccine is anywhere between
6 and 8 months, and could be several years if the trained personnel,
validated equipment, and entire production train were allowed to fall
into disuse. The warm-base program enables the manufacturer to provide
a ``turn-key'' operation, should an outbreak occur or demands for
production increase.
From the manufacturer's point of view, warm-base manufacturing
provides an incentive for the tremendous investment and compliance
costs associated with building and maintaining a specialized facility
for vaccine production. For example, in preparing to manufacture
ACAM2000, we modified facilities with specific capabilities for
handling the live smallpox virus, which took nearly 4 years to
complete.
At the end of the warm-base program, the government would have an
adequate stockpile to ensure domestic preparedness, and the
manufacturer would have been able to justify its investment. The
Executive Board of the World Health Organization recently highlighted
the importance of a warm-base manufacturing arrangement in a report on
the Global Vaccine Stockpile Reserve (dated December 23, 2004), citing
the need for not one but two active manufacturing locations in the
world.
Since it is Acambis' intention to file a Biologics License
Application for ACAM2000 in 2005 for FDA licensure, a warm-base program
would allow for steady replacement of the older vaccines with ACAM2000.
Once the smallpox vaccine stockpile is fully FDA licensed, the
government would no longer need to be concerned with informed consent
or issuing orders under Bioshield, which would ultimately speed up the
process of vaccination in the event of an attack.
Acambis presented a recommendation for warm-based manufacturing to
the CDC in December 2004, and is currently awaiting a decision on
whether the distribution of fiscal year 2005 funds will permit the CDC
to finance this request. However, a contract that only spans 1 year is
insufficient to warrant the investments we must make in warm-base
manufacturing. To be certain that our government is ensuring adequate
biodefense preparedness and an incentive for continual investments into
our smallpox vaccine facility, a more long-term arrangement is
necessary. Acambis has requested an extension of this program to the
CDC with funds to be appropriated in the fiscal year 2006 cycle.
The Need For Stable and Commercially Viable Funding Arrangements
Why is it necessary that manufacturers of biodefense
countermeasures have stable and commercially viable funding
arrangements for manufacturing to ensure continued scientific progress?
Allow me to expand on these issues and provide the subcommittee with a
sense of lessons learned from our public-private partnership.
First, as I suggested earlier, vaccine manufacturing is associated
with tremendous risk and cost. There are many companies ready and
willing to engage in early stage research for biodefense
countermeasures, but very few have the expertise, experience, and
facilities necessary to manufacture and deliver the vaccine. Acambis
and our partner, Baxter Vaccines, wish to be part of this manufacturing
base, but without the appropriate incentives for manufacturing, our
facilities and technological know-how will be used for purposes other
than biodefense.
At this point in time I would like to emphasize to members of the
subcommittee that, for biodefense countermeasures such as our ACAM2000
and MVA smallpox vaccines, our sole customer is the government. As
such, we rely on a private-public partnership that acknowledges the
unique concerns of our industry and encourages progress--not only from
research and product development to manufacturing, but also from
manufacturing to the final sale, in this case the Strategic National
Stockpile. Thus, continued scientific progress for biodefense can be
achieved if the manufacturer is presented with options that intend to
make the investment in production stable and worthwhile through support
for product industrialization or commercialization.
Secondly, Mr. Chairman, there is an enormous need for scientific
progress with other biodefense countermeasures. For example, as much as
20 percent of the U.S. population--60 million people--could suffer from
serious or potentially fatal adverse reactions if vaccinated with the
current smallpox vaccines in the case of an actual or threatened
smallpox outbreak. As part of Project Bioshield, the government has
recognized the need to protect this vulnerable population, which
includes individuals with compromised immune systems, HIV and skin
diseases, particularly eczema. Through contracts with the National
Institutes of Health, Acambis is now developing an attenuated smallpox
vaccine, known as MVA, intended for use by this sub-population.
A final solicitation to acquire this vaccine for the Strategic
National Stockpile is expected in 2005 under Project Bioshield. If the
value or size of this solicitation were to be below the 50 to 60
million doses originally projected by the NIH and the Congressional
Budget Office, it may be difficult to dedicate staff and facilities to
the project at the cost of pursuing other commercial opportunities, and
it would certainly make other manufacturers wary of committing to
develop countermeasures to other bioterrorism agents. Most importantly,
such a decision would leave a huge segment of the population without
access to the vaccine they need.
Acambis recognizes that the government must strike a balance
between prudent government purchasing and the multi-year cost to build
a domestic industrial base for biodefense products. Mr. Chairman and
members of the subcommittee, you are undoubtedly aware of the difficult
position America faced last year because it was dependent on a foreign
manufacturer of influenza vaccine. Strategically important vaccines
against epidemic diseases, such as smallpox, should be made in the
United States and not be subject to foreign control or dependent on
regulatory oversight of other countries. To achieve a viable domestic
capacity, however, the government must provide adequate incentives for
manufacturing. Acambis, as one of the few companies with the capability
to perform this activity, is willing to work with the government to
devise a solution that manages government costs while sustaining a
domestic biodefense readiness capability.
Concluding Remarks
Having stood at the frontline of biodefense work in the United
States to date and, in many areas, blazed a trail for other companies,
Acambis has developed a unique insight into this vital area. My
testimony today has focused on just one aspect of countermeasure
production where improvements are needed to ensure continued scientific
progress and the growth of a viable domestic industry. Other aspects
include a review of liability and regulatory provisions, particularly
concerning the animal model for testing and possibly tax credits.
Much is already being done to support innovative research in the
area of biodefense, but this is only part of a much larger and more
complex picture if scientific developments are to bring real benefits.
Incentives should apply as much to production as to development of
countermeasures. Acambis has been a proud and willing participant in
the biodefense arena to date. However, Acambis' and other companies'
continued participation is dependent upon a stable, commercial
arrangement for manufacturing, and upon government commitment to
stockpiling contracts, and production readiness or ``warm-base''
programs. Without these, the scarce and highly valuable resources and
capabilities of companies such as Acambis will be deployed in other
areas that are more commercially attractive, leaving the government
less able to fulfill its stated policy commitments.
Mr. Chairman, members of the subcommittee, I thank you once again
for inviting me to speak to you today and would be happy to answer any
questions you may have.
Senator Burr. At this time, I would recognize the chairman
of the full committee, Senator Enzi.
The Chairman. Thank you, Mr. Chairman. Dr. Painter, you run
a small company based in North Carolina and I think to have a
strong biodefense policy for the United States, we are going to
have to involve a lot of small companies. I am from Wyoming
where we do not have a single big business headquartered, and I
run a small business. I know that the Federal Government
sometimes needs to be reminded that small companies do not have
all the specialists that big ones do and it can be a little bit
more difficult for them to make it through the maze.
From your perspective, what does HHS need to do to ensure
that small companies like yours understand how to work with the
government or can you suggest some ways to make it easier to
work with the government?
Mr. Painter. Yes, Senator, that is a good question. From
our perspective, some clarity with regard to the nature of the
market. We recently went out and borrowed a significant amount
of venture money, and with that venture money, we can contract
expertise. So we can leverage our capacity to do development,
but the problem is we cannot tell the people we are borrowing
from how much smallpox drug the government might want to
procure because we do not understand how it would be applied
nor is there an overall process visible to us or a strategy for
using the drug in the event of attack.
So we do not know the market size. Furthermore, because of
the problems associated with the animal model, we cannot tell
investors the time to approval to sale. So without clarity, we
cannot answer the two critical questions that drive risk
determination in venture investment. So any clarity that can be
offered there will be of profound importance to our being able
to stay viable and get the countermeasure made.
The Chairman. Thank you. As you think of more of them,
convey those to us, too, because we want to be sure that small
business has a part in this. There is usually a lot more
flexibility and quickness to adapt to the market from small
businesses than there are from big ones, so we want to
encourage that.
Dr. Abramson, you called for no fault liability protection
systems for bioterrorism related to the vaccines that cover the
manufacturers and health care workers. You suggested the
compensation system that would cover medical expenses and lost
wages but not punitive damages. Do you believe this type of
protection is also important for the therapeutics that treat
these infections caused by these same agents?
Dr. Abramson. I think many of the issues are the same,
Senator, and a lot of times I would foresee us using drugs that
are nonFDA approved at all, forgetting age and indication, but
then we would be using them on a mass scale, and every drug,
every therapeutic we have has side effects, and somebody, not
one person but multiple people are going to be adversely
affected.
In a lot of ways, they're willing to take the vaccine, to
take the medicine helps protect the next person in society, and
so the people who do not do it we call sort of freeriders, and
you cannot have that in a mass emergency outbreak whether it is
a bioterrorist attack or not. So I see a lot of the same
issues. And I would call for the same measures.
The Chairman. OK. Thank you. Dr. Epstein, what would you
say to those who believe that additional incentives to produce
bioterror agents would just be a windfall to the biomedical
research community or the pharmaceutical industry?
Mr. Epstein. I think across the board incentives for
anything are something one has to look closely at, and I do
worry that if there is an incentive program and someone says,
you know, if we hang another molecular group on the end of this
drug, we can call it a new product and get another incentive.
So the details will matter. The incentives have to be ones that
actually get the benefits we want.
I personally, think that new, particularly a new broad
spectrum, a new class of antibiotic would be something I think
is very valuable, and by class of antibiotics, we have, each
antibiotic works by interfering with some mechanism in a
pathogen. It shuts off this particular molecule. You can have a
lot of variations of drugs that basically work on the same
principle but have different properties in the body, so a whole
family of drugs take effect at different speeds or they have
different dosages, but they all work on one basic mechanism.
Once the bugs figure out how to block that drug, all the drugs
in that class are gone, and we do not have very many classes of
antibiotics. If we had a new class, that means all the drugs
that are already out there working against microbes that have
found resistance to them, a new category of drug is one that
those bugs would not be resistant to.
So something that would provide a new class of drugs or a
major increase in our therapeutic ability is something I think
we need. So I do not consider that a windfall. One does have to
worry how the incentive is actually worded in detail, and by
the time the lawyers get done with it, I do not want someone
figuring out how to make a huge amount of money without really
making a contribution. So that means the details are going to
matter.
The Chairman. Thank you. Could I ask a couple more
questions?
Senator Burr. Absolutely.
The Chairman. Or would you prefer I did it in the second
round?
Senator Burr. Go ahead.
The Chairman. Thank you. Dr. Epstein, you mentioned that of
the 506 therapeutic candidates that there are really only 60
that are being worked on now. Would you consider with the
bioterrorism threat that is facing this country what number of
anti-infectives would you like to see in the pipeline to
indicate that we have a strong biodefense?
Mr. Epstein. Senator, I think the number was six. Of the
500 and something new candidate molecules or drugs, six
antibiotics and a smaller number of antivirals are in the
pipeline. I do not know what the right number is, but I do know
that the incentives facing the industry do not lead them in
this direction because when you have an infection and you take
an antibiotic for it, in 2 weeks, if you are lucky, it is
cleared up, and you are no longer a customer. So what makes
much money for the drug companies is a chronic condition where
you will be taking medication for the rest of your life, and I
cannot fault the companies for saying that is a better return
on their investment, and if they decided to do differently, the
stock markets would probably punish them for it.
So I do not know what the right number of anti-infectives
and antibiotics is, but I do think that we are not going to get
enough if it is just left to the market. I think we do have to
provide an explicit attention to increasing the number of new
drugs and therapeutics.
The Chairman. Thank you. One quick question for Dr.
Cameron. I could not help but notice that all of you in your
statement had something dealing with liability protection.
Could you expand a little bit more on what you are talking
about with the liability protection particularly?
Mr. Cameron. Well, in the context of ACAM2000, our
contract, we were able to secure liability protection through a
number of different efforts, the original contract and then
subsequently through legislation. So from our perspective, that
box was ticked, and it had to be ticked. It was a precondition
effectively toward taking on the contract. So all I would say
in that regard is we were okay in ACAM2000. I would just
encourage to make sure that all the other countermeasures
thereafter follow a similar pattern.
The Chairman. Thank you. Thank you, Mr. Chairman.
Senator Burr. Thank you, Mr. Chairman. Let me follow up on
that, Mr. Cameron, if I could. Without that box being checked,
without the total liability, could you have moved forward as a
company?
Mr. Cameron. We would not have.
Senator Burr. Would not have?
Mr. Cameron. No. Quite simply, we are a public company with
stockholders. They would not have accepted that potential risk
nor would we as a board of directors and as a company.
Senator Burr. So any company in a similar situation is
going to weigh risk in relation to the guaranteed sale. In this
particular case you might have ended up short of what you
thought, but there was a revenue projection that you were able
to match with that.
Mr. Cameron. Yes, I think all companies will assess risk in
whatever investment proposal they are looking at and trying to
define the risk associated with potential use of unlicensed
smallpox vaccine.
Senator Burr. Is there anybody within the world of
manufacture out there that is going to look at it any
differently?
Mr. Cameron. I can only speak for us. But if I was a
responsible leader of my company, I think I would look pretty
carefully. I think you need to obviously look at the profile of
the product and the likelihood of it actually being utilized. I
think clearly the smallpox vaccine, it had a history of adverse
events, so in that context then we needed to be extra, extra
vigilant. But it may well be with some other countermeasures or
other products where the risk is deemed to be lower.
Senator Burr. Does Acambis have any restrictions placed on
them for the sale of this product outside of our government's
contract?
Mr. Cameron. We are allowed to sell, as I highlighted
actually in my testimony, we have been and are allowed to sell
our product around the world and have sold to around 13
countries outside of the U.S. We are not allowed to sell to the
private market in the U.S. unless it has an ACIP
recommendation, but that is the only restriction per se,
although the control and the distribution and the sale of the
product outside of the U.S. is actually under the guise or
control of the FDA. So they are fully informed and fully
involved in that process.
Senator Burr. You talked about the wonderful job that FDA
did in this fast track approval process or fast track process.
Did FDA have individual FDA employees on site in your facility?
Mr. Cameron. There is a time they did. Yes, the interaction
was a mixture of people on site or regular telephone
conferences or whatever. I think the point is it was real-time
interaction so any issues that surfaced, and they did--issues
do surface as you go along--were able to be resolved in a very
timely manner rather than the typical process where they would
come in once every 12 months and visit a plant or visit a
facility or have a telephone conference.
Senator Burr. Is it safe to assume that a majority of their
concerns dealt with the manufacturing process?
Mr. Cameron. It is twofold. The issues were related to
manufacturing and the whole design of the clinical trials and
the protocols associated with them. There was a lot of
interaction with them, and then from a safety perspective as
much as anything else.
Senator Burr. Dr. Painter, some have referred to the
changes in this FDA fast track as we did it in the legislation,
that they look at that with great fear, that a small change
might become a large change, might become disastrous to the
rest of what FDA does. You mentioned the need for improved
animal models and offered a two-part solution. Can you give us
any more details about the solution, both the working groups
and the incentives for companies to participate in the
development?
Mr. Painter. Yes, sir, that is a difficult question. In the
case of utilizing animal models to try to develop a
therapeutic, it is unprecedented. I have worked many years on
Hepatitis B and C, HIV. We always had animal models, but those
models were to give an indication of activity in a living
organism, not to provide data for registration.
So as this idea of the animal efficacy rule gets reduced to
practice, the majority of questions that have come back to us
from FDA are relating to, is how do you know the model is
relevant? So there is going to have to be a lot of time and
effort put into that, and I think that private companies should
be incentivized to take on the challenge, and somehow there
would be a mechanism where they can gain revenue by improving
the model.
Working groups--the NIH has some of them. It is interesting
that a lot of the questions that are really relevant to proving
that a drug works, only evolve out of the interaction between
an FDA regulatory panel and the sponsor of the drug. So as the
vanguard goes through and the key questions get asked, they
need to be taken back to really real-front line working groups
to try to take the issues and reduce them to practice so that
we can move the indication forward.
That may not be a very satisfactory answer. I cannot be
very crisp. We are doing this in real time. And it has really
only been in the past 3 or 4 months that we have begun to
understand the questions from the FDA. How do we provide
guidance to a physician from efficacy in drug distribution data
in a mouse? And it may not be the right virus. We do not know
what viruses were weaponized. At what rate does that virus
replicate in the blood. We have to get some answers.
Senator Burr. Without that flexibility of changes, could
you even move forward?
Mr. Painter. No, we need flexibility and I must say that I
am encouraged by the degree of flexibility and the dedication
and the interactions we have had with the people at the NIAID,
the people in academia, and we have had the same experience.
The CDER regulatory people at FDA have responded to us in real
time which is unprecedented.
Senator Burr. I would mention to all of you the further we
get away from September 11, 2001, the greater concern I have
with our ability to have a long-term program that addresses us
in the same fashion as we are learning today as we try to go
out and get these enacted. It is safe to say that if today you
were at a point with your antiviral and we had a smallpox
attack, if the Federal Government said for the sake of
mortality, we want to go ahead and give this to people, you are
protected from liability when they make that decision based
upon some acts we have already done.
If you were not doing what you are, if there was no company
out there, sort of in the antiviral world for smallpox, what
would happen?
Mr. Painter. I think we would lose a lot of our citizens.
There would not be a capacity to respond.
Senator Burr. Does this debate, this decision that we have
got in Congress, does it come down to that that is black and
white?
Mr. Painter. The question that we are constantly asked,
particularly by investors, is they want to discount our value
based on attack probability. Is there going to be an attack?
There seems to be a wide range of opinions. If the attack is
using smallpox, if there is a high probability, and that is
known, then I think we should move heaven and earth to do
anything that is possible to get every countermeasure on line
so that we have antivirals to augment vaccines.
Senator Burr. Let me ask any of you about what I would call
and some of you have dual use products, those that might be
applicable to a particular area of concern that we have from a
bioterrorist standpoint, that either up front we know or later
on we learn, that they have a commercial marketplace for them.
And rather than ask you specifics or to be general on how
we deal with them, let me ask a specific if I could. Is it
conceivable that were we to come up with a set of incentives
for those products to enter our system, could we have a
separate regimen for those same products introduced into the
commercial stream? In other words, were we to extend patents on
this side, could we, in fact, mirror existing patents on the
commercial side were we to choose to do that?
Mr. Painter. I would like to jump to the mike on that one.
We have the possibility of dual use in the smallpox drug. And I
would like to add that to Dr. Epstein's challenge to have broad
spectrum antiviral agents, if one can indeed find such an
agent, and they are very rare, there is only one that I know of
right now, then in all probability its applicability will
extend beyond the weaponized to more common needs for
antivirals.
So in order to have success, as he asked for, then we will
indeed have this issue. Certainly, anything that will
incentivize and provide additional opportunity for companies,
particularly now, for dual use, where there are at least
perceived to be quite large uncertainties on the commercial
side by investors, would incentivize not only people to stay,
but give them a way to live through some of the uncertainties
and ups and downs as we try to answer the questions like the
animal model that we have to get past.
If on a parallel path, we can keep a commercial product
going, then the company can remain viable, and I might add that
any experience you get either on the biodefense side or on
developing a drug for a commercial use, you can leverage that
to expedite development on either side.
So these two uses are intertwined and when you confine
them, I think they need to be encouraged, not discouraged or
looked upon as a liability.
Mr. Epstein. Mr. Chairman, let me add to that. I think
clearly today we can say there is a difference between
commercial products and biodefense products. Commercial
products are the ones that have been on the market and the
biodefense products have not, and we have had a short list of
bio-threat agents we have been working on because there are a
couple that are so much worse than others--we say smallpox and
anthrax, and let us start there. And then you get a very long
list. We have a Category A, but nature does not draw sharp
lines, and I think as we go into the future, it is going to be
harder and harder to say what is biodefense and what is public
health.
If we have SARS and it gets distributed as a weapon. Even
the term ``weaponized'' really dates back to military conflict
where you have to make a bug that can be spread over a
battlefield and stay alive when it goes 20 kilometers downwind.
If you are in a shopping mall with a perfume sprayer, is that
weaponization? I think the era we are getting to gets back to
what I was saying, the inability of firm intelligence to really
guide us with specifics and a corollary to that is the
inability to draw some of these sharp distinctions, and I think
it does pose a real problem if public policy tries to treat
biodefense differently than public health or than commercial
products.
It is going to, again, now we can do it. The first
Bioshield results did that. But it is going to be harder and
harder to keep those straight as we go on, and I think it will
probably mislead us and maybe get us to the wrong answer.
Senator Burr. I said at the beginning I thought one of the
obligations we had was to be ahead of the curve so even though
there may be some people behind me that are cringing as I ask
that question, why are you going there, why would you get into
this now, I think it is real important that we talk about it.
And it means something different potentially to somebody in
academia than it might mean to a CEO of a company that is very
reliant on the capital markets to finance tomorrow and next
year and the year after, and for somebody like Mr. Cameron who
may already be out there, might already have this experience of
some type of dual markets, there is some light that can be very
important to us as we head down this road.
Dr. Abramson.
Dr. Abramson. I think influenza is the prime example of the
blurring of this issue. So H5N1 is sitting over in Asia and is
one, probably one, genetic mutation away, whether it is
weaponized by somebody or just occurs in nature from being able
to be transmitted person to person. So you have an extremely
virulent organism that when it does get into a person kills
them at a very high rate, somewhere in the range of about 50 to
70 percent, and it is one small mutation away from being able
to be a true mass pandemic. And I see a lot of trouble in
trying to split hairs here in differentiating something like
that.
Senator Burr. Well, you spoke specifically to the liability
issue, and let me ask you to elaborate a little bit more. There
are some that believe that current law provides a sufficient
protection or assurance for a robust interest of companies to
become involved. Dr. Fauci and I focused on the word
``robust,'' and I am not sure that we know, in fact, in this
spirit what the definition of it is yet. I think you explained
very well that Bioshield ultimately cannot be successful----
Dr. Abramson. That is right.
Senator Burr [continuing]. Unless we address liability.
Specifically why?
Dr. Abramson. Well, again, I will use the H5N1 as an
example. I do not see a company willing to be able to produce
that product or drugs that are needed against that product,
because some of the antivirals that we have against influenza
do not work against that particular bug, without knowing that--
if it is going to be used for millions and millions, and I mean
literally that many people, there will be side effects that are
true, and there will be side effects that are associated, and
there is going to be an extremely high risk from a legal
standpoint that the company is going to have to assume--and I
do not see companies willing to do that. I have had lots of
discussions in trying to think about pandemic flu about this,
and I get no sense that they really want to step up to the
plate and take on this risk without that kind of protection.
Senator Burr. Let me once again thank our witnesses and let
me say to Dr. Painter the question you have raised as it
relates to Soviet scientists, the collaboration, if we are not
aware of the answer to the question you raised, I can assure
you that it is something that we will pursue and hopefully
Senator Roberts as well will pursue that from an avenue of
other committees, specifically Intelligence that he has the
chairmanship of.
As I said at the beginning, I see this as the first of
several hearings that enable us to prepare for the possibility
of further legislation, legislation that would be for the
purposes of refinement of Bioshield. If for some reason we get
through the process and we find that short-term that is not
needed, we do have a reauthorization that comes up very soon
where there is another opportunity to refine the product that
came out.
Our goal is to create the capability to deal with the
unknown. I mean you have helped us focus on particular things
that are out there and the Department of Homeland Security has
a hit list and Dr. Fauci has a hit list over at NIH and there
certainly is a lot of commonality in all the lists. If we are
truly ahead of the curve, then we have to be designing some
type of structure that addresses what is not on the list. What
gives us the capabilities, the flexibilities, the assurance
that when something happens, that we are at a point where
everything just progresses naturally. And we have got the
ability to have an answer.
I am not sure that we are there yet, and I think your
testimonies today have enabled us to realize that in a very
real way. I am disappointed that nobody or at least our first
witnesses from HHS and DHS did not stick around. I think
outside of antitrust, this is a great opportunity to hear from
people who have companies and individuals within academia who
really are experts on this, and I would encourage any
representatives from there to make sure that those individuals
have an opportunity to read the testimony, and I would
encourage those agencies in the future that it is probably to
everybody's benefit for witnesses to stay around. If not, we
will reverse the order of the subcommittee hearing so that they
are forced to stick around because I think that their interest,
not just their expertise, their interest is needed if, in fact,
we are all to be successful in this process.
At this time, I would ask unanimous consent that the record
of this hearing remain open for 10 days as is customary on this
committee so that members may have the opportunity to pose
additional questions to our witnesses. Without objection so
ordered. We also have written testimony of several witnesses
submitted by Senator Bingaman, and without objection, it will
be entered into the record.
Senator Burr. This subcommittee hearing is adjourned.
[Additional material follows.]
ADDITIONAL MATERIAL
Generic Pharmaceutical Association,
February 8, 2005.
Hon. Richard Burr,
Hon. Edward Kennedy,
Subcommittee on Bioterrorism and Public Health Preparedness,
Senate Health, Education, Labor, and Pensions Committee,
U.S. Senate,
Washington, D.C. 20510.
Dear Chairman Burr and Ranking Member Kennedy: As Congress looks
for ways to better protect the population against potential biological
threats, it is vital that any initiative: (1) uses appropriate
financial and legal liability protection incentives to produce a novel
countermeasure against known chemical or biological agents; (2)
provides for rapid production and dispersal of the countermeasures; (3)
spreads the costs of research and development evenly; and (4) avoids
unnecessarily and excessively increasing cost to consumers, businesses,
and public purchasers by providing new loopholes to block access to
affordable generic drugs.
The BioShield bill that was signed into law last year was a
positive first step toward finding and producing vaccines and
treatments for several high-risk agents. Although the program is just
getting started, there already has been a movement in Congress to
expand BioShield to include additional incentives for companies to
conduct research and development to manufacture a larger variety of
countermeasures. While GPhA supports the concepts behind expanding
research and development of novel drugs to combat the biological and
chemical threats that face the world, any proposal should not
needlessly delay generic competition of everyday medicines at the
expense of the overstretched health care budgets of employers,
consumers, and Federal and State Governments.
The Protecting America in the War on Terror Act of 2005 (S. 3)
remedies some of the shortcomings of the BioShield legislation;
however, it includes unnecessary patent extensions for everyday
medicines that will cost consumers tens of billions of dollars by
delaying generic competition. With Medicaid reform on the horizon,
State health budgets shrinking, and the Medicare prescription drug
program coming into effect in the coming year, the Federal Government
cannot afford to further increase prescription costs by billions of
dollars a year by needlessly reducing the availability of affordable
medicines.
S. 3 would give a very wide variety of everyday medicines UNLIMITED
patent extensions, providing brand manufacturers with huge payouts for
minimal research or licensing efforts at the expense of consumers,
especially seniors and the uninsured--individuals who need affordable
versions of these medicines most. (Title I, Subtitle A, Chapter 1,
Section 113 (c)(1)).
S. 3 defines a countermeasure so broadly that almost every
drug in most people's medicine cabinets would qualify. Commonly
prescribed drugs that treat headaches, nausea, and depression would be
eligible for patent extensions with minimal testing performed by the
brand manufacturer. Patent extensions on these products would put the
healthcare system in crisis by forcing tens of billions of dollars in
expenditures on these already profitable drugs.
S. 3 would extend the patent terms of products that
qualify as countermeasures up to the full amount of time from when the
patent is issued until the product is approved. Current law balances
innovation and access by providing only 5 years of the regulatory
review period to be added to the patent's life. If a company were given
the full review time under an unlimited regulatory review period, it
could add a decade of patent exclusivity and monopoly pricing per brand
product. Moreover, providing patent extension for the full development
time is contrary to the intent of the goal of expediting research and
development.
S. 3 also would allow for unlimited patent extensions per
product. Under current law, only one patent can be extended for
developing a novel drug product. Under S. 3, multiple patents claiming
the brand drug can be extended, forcing consumers to pay monopoly
prices for many years to come.
S. 3 allows for ANY patent on ANY drug product of a brand company
to be extended by up to 2 years when that company has a product
approved as a countermeasure. (Title I, Subtitle A, Chapter 1, Section
113 (d)(1)).
When the company gets a countermeasure product approved
(even for a secondary use to treat a common ailment, or merely licenses
research from some other entity), the company is eligible to receive a
``wild card'' patent extension. This ``wild card'' in effect transfers
the awarded patent extension to any other product the company makes.
For example, if Pfizer were to have a countermeasure labeling statement
approved for an already existing product, it could reap up to 2 extra
years of patent monopoly for a blockbuster drug such as Viagra.
And, if Pfizer decided to license a product for which
another drug company performed all the requisite research and
development, Pfizer could still receive yet another wild card. This
time, Pfizer could decide to extend its monopoly for another one of its
blockbuster drugs, or put a second wild card on Viagra.
The result of this legislation would be an additional 2
year delay of generic competition for all major blockbuster drugs. If
the ``wild card'' extension was only applied to the current top 20
revenue generating pharmaceuticals, it would provide tens of billions
of dollars in uncontested sales for the brand manufacturer.
Additionally, as the term implies, the ``wild card''
extension can be pocketed by the company and can be applied at any time
before patent expiration, creating uncertainty for generic companies to
invest in the requisite development of affordable medicines. Having
certainty in timing as far out as possible before the patent and
exclusivity periods end is what allows affordable medicines to enter
the market quickly, efficiently, and inexpensively. Any added
uncertainty will increase costs for all generic pharmaceuticals in the
future.
While S. 3 allows for brand companies to be rewarded for the simple
testing for new indications of currently marketed drugs, the Federal
Government already has determined which everyday medicines are
effective countermeasures for known bioterror threats.
For instance, the CDC, NIH--NIIAD and Department of Defense provide
a wealth of information on currently available products to use in case
of exposure to many forms of biological and chemical agents. Since the
research already has been performed at taxpayers' expense, there is no
reason the brand pharmaceutical company that manufactures the product
should be given any additional patent life on that product or any other
product.
It would be much more efficient and cost effective for the
FDA to establish an ``Emergency Drug Preparedness Compendium''
consisting of an approved emergency biodefense drug monograph for each
drug a Federal agency (CDC, USAMRIID, NIAID, DOD, USDA, etc.) has
identified as an effective agent to treat, detect or prevent harm from
any biological (including an infectious disease), chemical,
radiological, or nuclear agent that may cause a public health emergency
affecting national security.
GPhA does support many of the ideas included in S. 3 that are
needed to facilitate future development of vaccines and other
treatments for bioterrorism threats. As Congress looks forward to
determining the best course of action, it is important that these
provisions are included in the legislation.
S. 3 includes necessary liability protections for drug
manufacturers as they develop and produce these potentially life-saving
treatments. (Title I, Subtitle B, Chapters 1 and 2).
S. 3 also includes tax incentives and manufacturing grants
to companies for research and development in bioterrorism
countermeasures. (Title Subtitle B, Chapter 3). As the vast majority of
research is done by small biotechnology companies, these incentives are
much more pertinent than patent extensions that would have little or no
benefit to these companies.
S. 3 includes fast-track approval authority for these
products. Allowing FDA to speed these countermeasures to market will
ensure that they are available when they are needed. (Title I, Subtitle
A, Chapter 2).
The BioShield program has been a success in its short history, and
any expansion of these provisions should be based on the same
procurement model incorporated in that legislation.
The upfront funding gives the research companies the
resources they need at a fraction of the cost that would result from
unlimited, protracted and needless patent extension provisions.
The Federal Government already has contracted $5.6 billion
in research for vaccines and treatments for the agents spelled out in
the original BioShield legislation last year. Additionally, without the
need for any further incentives, vaccines for smallpox, modified
anthrax, and ebola are now close to being approved.
Sincerely,
Kathleen D. Jaeger,
President and CEO.
Prepared Statement of Randi Airola
I am a Veteran who served honorably in the Army and Air National
Guard from 1991-2000. This testimony is to serve as part of the public
record regarding ``Biodefense Next Steps'' as presented to the
Subcommittee on Bioterrorism and Public Health Preparedness.
I received my first 3 doses of the anthrax vaccine in late 1998,
followed by the 4th injection in March of 1999. Two days following my
4th shot I began experiencing extreme fatigue that nearly kept me bed-
ridden the following week. I began noticing I would get gray-outs with
overexertion. I had such severe migraines that I averaged approximately
16,000 mg. of Motrin daily. I began getting winded climbing a flight of
stairs. I noticed when I bent my joints there was an audible crack;
others noticed it, too. I had no strength in my arms or my legs. I
forgot passwords to programs that I would use everyday. I was easily
confused and found myself unable to concentrate or focus on more than
one task at a time. I was easily agitated and it took everything I had
to hold back on acting out physically. I was 26 years old at the time,
with no history on any of the above problems preceding my 4th shot. I
was seeing civilian doctors weekly who were baffled by my condition,
considering I was previously in perfect health. In a 2 month time span,
I missed approximately 140 hours of work, and no one in command
authority found this to be a sign that there was something wrong. I had
a cat scan and MRI done to check for tumors to possibly explain the
migraines. It was determined that I was too young to have had a stroke,
so the cause of the paralysis that would occasionally occur on the left
side of my body with a cough or sneeze was left undetermined. Military
doctors never examined me, nor seemed interested. When the time came to
receive my 5th shot, I was still experiencing the above problems. I was
denied any referral to see a competent military physician for a second
opinion. As a result of my problems, for the sake of my own health, I
refused my 5th shot. I was ultimately discharged from service with an
honorable discharge. As a result, I also lost my civilian position as
an Air Technician. I was not eligible for VA disability or
compensation, as I was never classified as Active Duty.
From 1999 through 2002 I was on approximately 19 different
medications for my ailments. I ultimately received help through a
nutritionist; today, I am on no medications.
I am directly and intimately involved with the Military Vaccine
Education Center, Inc., at www.milvacs.org, which was formed in 2004.
The organization exists to provide medical and legal resources,
networking, and current information to those who have been vaccinated
by the military's mandatory bioterrorism vaccines. We help soldiers/
veterans and their families with referrals, the process of going
through Medical Evaluation Boards; the process of receiving treatment
through the Vaccine Healthcare Centers, V.A. disability or
compensation, etc. I have chosen to stay involved with our soldiers and
the problems surrounding the anthrax biological vaccines, as I know
first hand the debilitating problems that soldiers and their family can
go through. It was one of the worst experiences in my life, and as long
as I was and am able to, I have chosen to help others who were and are
in the same shoes I was in. I have communicated with over 1,000 service
members (or members of their families) who were/are having problems
with the anthrax vaccine. Last year, I compiled the records of 100
individuals into a 36-page document that I sent to the Veterans'
Affairs Committee. All of these individuals had reported their problems
and vaccine reactions to me within a 6 month time period. No one on
that committee seemed to care, as I never heard a response.
I took the initiative to learn the process of how soldiers were to
get help through the Walter Reed Vaccine Healthcare Center(s), a
process mandated by Congress in 2001. This information was not being
passed down to the troops by the Department of Defense or by their
chain of command.
With the anthrax vaccine alone, I have spoken with and met many
soldiers who all had one thing in common. They were all healthy before
the anthrax vaccine, and are now stuck with a life-changing ailment for
a time that no one knows how long considering long-term studies have
not been conducted. Some in their 20's, walk with the assistance of a
cane; some cannot walk at all. Some were able to get help through the
Vaccine Healthcare Centers, which at least helped them through their
Medical Evaluation Board and VA compensation; others were not that
fortunate.
As of now, as noted in an article in Global Security Newswire,
``U.S. Army Provides no Funds for Vaccine Healthcare Centers,'' as
quoted by Col. Renata Engler, the Walter Reed Vaccine Healthcare Center
evaluated over 1,000 patients, and consulted with more than 139,000
individuals via phone/email as a result of problems with the anthrax/
smallpox vaccine in 2003 alone. The Vaccine Healthcare Centers are
always on the verge of losing their funding, and are overloaded with
the current anthrax and smallpox vaccine caseloads; yet more biological
vaccines are being discussed and developed. Who is going to take care
of those that become ill from these new vaccines, or is that not a
factor? No information will be available regarding human data for
safety studies, so how many soldiers will be denied admission of a
causal relationship between adverse events and the vaccines?
The War on Terror has become a droning drum beat that many believe
exists solely for the purpose to benefit the pharmaceutical companies
and their shareholders. If protection of the soldiers or the American
people were actually the focus, then better detection and outer
protective equipment would be the primary goal. It stands to reason
that if an enemy knows a vaccine exists for a specific strain of
biological warfare, a genetic alteration of that strain would render
that vaccine useless. Where is the logic of spending billions of
dollars on biopreparedness through vaccinations, where the only thing
that is at least known is that it can become easily obsolete?
Who will regulate the use of these vaccines?
The DOD? The agency that can't even comply with a Federal
Judge's order or Congress?
Vaccinations were given despite Judges Order; http://
www.washingtonpost.com/wp-dyn/articles/A59190-
2005Feb2.html?sub=AR
``DOD's medical credibility disputed'' http://
www.govexec.com/dailyfed/0200/020100b3.htm
``Army Proposal to use U.S. Soldiers as Human Test
Subjects;'' (http://www.bna.com/press/guest/aotto.htm).
``U.S. Army Buys $30 Million in Anthrax Shots''
(http://dailynews.att.net/cgi-bin/
news?e=pri&dt=040102&cat=news&st=newshealthan). \1\
---------------------------------------------------------------------------
\1\ The Defense Department announced on Friday a $29.7 million
order for anthrax vaccine based on the assumption that a Federal
judge's ban on mandatory inoculations will be served.
---------------------------------------------------------------------------
The FDA? As best put by David Graham in his testimony
before a Senate hearing:
``This culture [at the FDA] views the pharmaceutical
industry it is supposed to regulate as its client. It
overvalues the benefits of the drugs it approves, and seriously
undervalues, disregards and disrespects drug safety.''
``The FDA, as presently configured, is incapable of
protecting Americans against another Vioxx.''
The NIH? The agency that has recently come under fire for
its conflict of interest with the drug manufacturers?
``Panel Wants Top Health Officials Off Drug
Payrolls,'' (http://www.ahrp.org/infomail/04/05/07.php).
``NIH to Ban Deals with Drug Firms'' (http://
www.latimes.com/news/nationworld/nation/la-na-
nih1feb01%2C0%2C5059199.story?coll=la-home-headlines). \2\
---------------------------------------------------------------------------
\2\ For the last decade, government scientists at the NIH have
quietly been allowed to consult for biomedical companies under policies
that defenders have said helped attract talented personnel to the
agency. Hundreds of scientists took millions of dollars in fees and
stock from industry. Most of the payments were hidden from public view,
raising questions about the scientists' impartiality in overseeing
clinical trials and in making recommendations to doctors for treating
patients. In some cases, NIH scientists worked for drug companies that
directly benefited from their recommendations to doctors. In other
cases, scientists appeared at public forums and commented upon or
endorsed treatments or drugs without revealing that they were on the
payroll of companies making the products.
---------------------------------------------------------------------------
The regulating agencies have become such a revolving door, it's
hard to determine where one agency ends and the drug manufacturer's
door begins. Though NIH is taking steps to correct the conflict of
interest, the fact that such a move even needs to occur should sound
major alarms. The public is becoming extremely wary of these regulating
agencies. People within these agencies have lost sight of their primary
responsibility to the public, unable to see beyond their own greed.
I'd like to remind the committee of the Government's own words on
vaccination biological programs:
``House Democrats Call for Revitalizing U.S. Smallpox
Vaccine Program'' (http://www.nti.org/d newswire/issues/2004 1
29.html#88E92E9A). \3\
---------------------------------------------------------------------------
\3\ Calling Federal efforts to vaccinate U.S. health care workers
against smallpox ``an embarrassing failure of government, with serious
implications for homeland security,'' Democracts in the U.S. House of
Representatives yesterday called on the Bush administration to reassess
the smallpox bioterrorist threat and improve the U.S. ability to
respond to such an attack.
---------------------------------------------------------------------------
Study Slams Biodefense Plan (http://www.boston.com/news/
nation/articles/2004/01/23/study slams biodefense plan/). \4\
---------------------------------------------------------------------------
\4\ The Pentagon's efforts at creating new vaccines and drugs to
combat biological weapons are poorly organized, under-funded, and
unlikely to produce successful results in the near term, if ever,
according to a congressionally mandated study released yesterday.
---------------------------------------------------------------------------
We do not know the final outcome of the current vaccines in use,
let alone any new ones that are yet to come. So far, what is known is
that the anthrax vaccine has been linked to birth defects, spontaneous
miscarriages, auto-immune disorders, which include (but are not limited
to): Bell's palsy; Guillain Barre Syndrome; Multiple Sclerosis; Lupus
and heart disease.
(http://www.fayettevillenc.com/printer.php?Story=6787445).\5\
---------------------------------------------------------------------------
\5\ Tech. Sgt. Lavester Brown almost died last year when his heart
swelled to twice normal size hours after he received an anthrax
vaccination. A few months later, he had to have a heart transplant.
---------------------------------------------------------------------------
Taken directly from the product label, further associations to the
anthrax vaccine, to also include death, are as follows:
``Other infrequently reported serious adverse events that have
occurred in persons who have received BioThrax have included:
cellulitis, cysts, pemphigus vulgaris, endocarditis, sepsis, angioedema
and other hypersensitivity reactions, asthma, aplastic anemia,
neutropenia, idiopathic thrombocytopenia purpura, lymphoma, leukemia,
collagen vascular disease, systemic lupus erythematosus, multiple
sclerosis, polyarteritis nodosa, inflammatory arthritis, transverse
myelitis, Guillain-Barre Syndrome, immune deficiency, seizure, mental
status changes, psychiatric disorders, tremors, cerebrovascular
accident (CVA), facial palsy, hearing and visual disorders, aseptic
meningitis, encephalitis, myocarditis, cardiomyopathy, atrial
fibrillation, syncope, glomerulonephritis, renal failure, spontaneous
abortion and liver abscess. Infrequent reports were also received of
multisystem disorders defined as chronic symptoms involving at least
two of the following three categories: fatigue, mood-cognition,
musculoskeletal system.
Reports of fatalities included sudden cardiac arrest (2),
myocardial infarction with polyarteritis nodosa (1), aplastic anemia
(1), suicide (1) and central nervous system (CNS) lymphoma (1). (http:/
/www.bioportcorp.com/AnthraxVaccine/insert/avainsert.asp).
According to Ron Brookmeyer, a professor of biostatistics at Johns
Hopkins Bloomberg School of Public Health, mass vaccination programs
aimed at protecting most or all Americans against anthrax are
impractical and would save fewer lives than a speedy, localized
response in the event of an attack, a new report concludes. \6\
---------------------------------------------------------------------------
\6\ http://www.forbes.com/lifestyle/health/feeds/hscout/2004/12/15/
hscout522909.html.
---------------------------------------------------------------------------
The smallpox vaccine has been linked to enough heart problems that
the civilian program for first responders was put to a halt; yet it's
still mandatory for our military personnel. \7\
---------------------------------------------------------------------------
\7\ Lexis-Nexis--Friday September 3, 2004--Vaccine-induced heart
problems; Smallpox vaccinations and anthrax vaccine--Smallpox
vaccinations have been linked to serious heart problems. Seventy-seven
of over 615,000 (1.25 percent), according to the Pentagon, have
developed myopericarditis, an inflammation of the sac around the heart.
The Centers for Disease Control say that 21 of the 39,500 (5.3 percent)
U.S. medical professionals who received the vaccination also contracted
the illness. When three people enrolled in clinical trials to test a
new smallpox vaccine, developed by British biotechnology company
Acambis, also developed myopericarditis, the company ended the trial.
The anthrax vaccine, which is also linked to heart attacks and strokes,
is being implicated in unexplained blood clot disorders, according to a
report by United Press International (October 6, 2003). The label on
the anthrax vaccine given to military personnel ``warns of infrequent
reports of heart attacks or strokes.'' Both can be caused by blood
clots. Several soldiers and an NBC news correspondent have suffered--
and in some cases died--because of unexplained blood clots.
---------------------------------------------------------------------------
Further vaccinations that are in the talking/planning stage to be
tested on our soldiers should be used only with informed consent. Any
forced vaccinations on our troops would make the U.S. Government solely
responsible for any and all negative outcomes regarding adverse events,
which will inevitably occur. Has the committee considered how many
negative adverse events or deaths from these vaccines will be
considered an acceptable loss? According to President Bush's State of
the Union Address on February 2, 2005, ``the destruction of life is not
acceptable for medical research.'' It takes 5 to 7 years after approval
before a new drug's risks are fully understood. Do these biological
vaccination programs not stand in complete contrast to the President's
own words?
It is the members of our Armed Forces that will be forced to test
these vaccinations, with no option of refusing, no recourse to take
should they become ill and lose their health and career; yet talk
continues about shielding the manufacturer's from liability should
these events occur--what about our service members? Where is their
shielding? Pure rhetoric rallies support for our troops from the
legislature at election time, or the beginning of wars, yet falls short
when it comes time to put actions behind the words. Our military has
given our Nation their all; should they at least not be given some of
their God-given rights: The right to have integrity over their own
bodies?
The continuous rotation of deployment of our troops in Afghanistan
and Iraq with the War on Terrorism, has caused a major strain on our
forces. Further requirements of biological vaccinations with unknown
risk factors will break an already thin force. \8\
---------------------------------------------------------------------------
\8\ When the military ordered all military personnel bound for
Korea and the Middle East to be inoculated with the anthrax vaccine,
pilots staged a massive walkout at Dover Air Force Base, where the Air
Force's largest cargo aircraft are flown.
---------------------------------------------------------------------------
``Dover short pilots since vaccine order'' (http://
www.delawareonline.com/newsjournal/local/2004/12/
28dovershortpilot.html).
The men and women who serve in our military may not be your sons or
daughters, but they are someone's. As you think about the ``Next Steps
in Biopreparedness,'' please keep that in mind. Until then, my
colleagues and I will continue to assist the soldiers and their
families the best we can--those whose lives have already been
destroyed, by just two of these biological vaccines.
The Government continues to try and find ways to combat terrorism
and biological warfare. Aggressive measures should be taken; however,
we need an honest and open assessment from all parties concerned
regarding biopreparedness and the next steps, which goes beyond
pharmaceutical companies and the NIH. Our Nation is billions of dollars
in debt, and spending billions of more dollars on biological
vaccination programs that may fail on all counts, is financially and
morally irresponsible. I submit my testimony today not as an expert in
biowarfare, but, as a concerned individual that has seen, in some
cases, the deadly and life-changing result that has occurred from
biological vaccines.
I am a volunteer, and I do this willingly along with my colleagues,
considering we care more about our troops than the Department of
Defense or most of those in the legislature. Perhaps when the members
of Congress have to begin getting intimately involved in receiving
these vaccinations, or enlisting their sons and daughters into the
Armed Forces, they may finally realize that those receiving these
vaccines are, in fact, human beings, not dispensable models. Perhaps
then, Congress will begin to provide the civilian oversight of the
Department of Defense as it is supposed to do. Perhaps then, the
Department of Defense can get back under control; and perhaps then,
soldiers will once again begin to display faith in their leadership.
In closing, I am willing, at any time, to speak with anyone
concerning any questions you may have. My email address is:
[email protected]; my phone number is 517-819-5926. Thank you for the
opportunity to submit this written testimony for public record.
Statement of Meryl Nass, M.D.
Thank you for the opportunity to submit this testimony for the
record. My name is Meryl Nass, M.D., and I have worked for the past 20
years as an emergency physician and internist in community hospitals. I
have also studied many aspects of bioterrorism since 1989. I am the
person who first demonstrated that one could investigate an epidemic
retrospectively, and prove that it was due to biological warfare, using
Rhodesia's 1978-1980 anthrax epidemic as a model.\1\
---------------------------------------------------------------------------
\1\ Nass M. Anthrax Epizootic in Zimbabwe 1978-1980: Due to
Deliberate Spread? PSR Quarterly, 1992; 2: 198-209. http://
www.anthraxvaccine.org/zimbabwe.html.
---------------------------------------------------------------------------
Since then I have authored and coauthored numerous documents on the
subjects of preventing, investigating and ameliorating the effects of a
bioterror attack. These included recommendations to the Biological
Weapons Convention Review Conference of 1996, \2\ and a Congressional
testimony on medical responses to bioterrorism in November 2001.\3\
---------------------------------------------------------------------------
\2\ Report of the Subgroup on Investigation of Alleged Use or
Release of Biological or Toxin Weapons Agents. Federation of American
Scientists Working Group on Biological Weapons Verification, April
1996.
\3\ Preparing a Medical Response to Bioterrorism. Written Testimony
of Meryl Nass, M.D. House Committee on Government Reform hearing,
November 14, 2001: Comprehensive Medical Care for Bioterrorism
Exposure.
---------------------------------------------------------------------------
Because I continue to practice medicine, have a strong background
in biological warfare, and do not consult for the drug industry, my
concerns may differ from most Congressional witnesses. They are:
(1) Achieve maximal readiness at the local level.
(2) Assure the development and availability of safe and effective
measures, especially drugs and vaccines, to protect our citizens.
(3) Urge a much stronger focus on prevention of bioterrorism.
Although it is a truism that it is impossible to fully protect our
population against this form of attack, in our rush to buy protections
we seem to ignore their limitations. The ability of an enemy to defeat
our preparations will increase in the future. Furthermore, the
potential for biowarfare to destroy whole species or even end life as
we know it is not inconsiderable.
I'd like to briefly cover these three issues. With respect to local
readiness:
Through State and Federal grants, hospitals have been given
antidotes for chemical agents, and other appropriate drugs for use in a
limited chemical or bioterrorism event. Hospitals do not have
sufficient stockpiles of these substances to care for more than a tiny
percentage of the population, should a massive event occur. We have
even fewer people with the knowledge or experience to take charge of
the situation appropriately, should a terrorism event occur. We lack
sufficient gloves, gowns and masks on site in the hospital to handle a
sustained infectious catastrophe.
Our practice and knowledge of infection control needs to be
improved. During the past month my hospital had several cases of
hospital-acquired influenza in both staff and patients, despite
following CDC-specified infection control measures. This occurred, in
my opinion, because CDC did not pay adequate attention to transmission
of the virus by fomites (inanimate objects that harbored transmissible
virus) and because we had patients who were spreading virus prior to
being diagnosed with the infection, i.e., before appropriate control
measures were instituted, because it took up to 24 hours to get lab
confirmation of the diagnosis. As most of the flu cases I cared for had
received flu vaccine, flu was not suspected initially. Yet the vaccine
apparently failed to protect them.
Attention to improving our understanding of infectious disease
management will yield great dividends in helping us control a
bioterrorism event. I am simply repeating what many others have said:
the public health system has been a poor stepchild of the medical
system for decades, generally relegated to providing a modicum of care
for those who cannot pay, and handling conditions like tuberculosis and
sexually transmitted diseases. It needs to expand its horizons, and it
should become fully integrated into our practice of medicine.
My second concern is that the provision of safe and effective drugs
and vaccines to our population is of utmost importance. However, we
cannot develop and manufacture a vaccine or antidote for every possible
infectious agent for compelling reasons:
(a) we do not yet know how to do so (witness the lack of an AIDS
vaccine or an effective drug for viral hepatitis).
(b) the number and variety of potential pathogens is infinite, so
we cannot predict or identify all the pathogens that might be used as
weapons, which makes finding treatments difficult or impossible.
(c) the cost of developing and producing even one drug or vaccine
for the entire population is likely to range from one to many billion
dollars.
At this point, the United States has not even begun to develop a
surge capacity for manufacturing such products, although it is clear
this is what is required. My 2001 Congressional testimony included many
suggestions for rapid development of effective drugs and vaccines, so I
will not belabor those points today.
What is urgently needed by the Nation is for a group of
knowledgeable, nonpartisan experts in and out of government to review
our weaknesses and strengths, and plan an overall approach to the
problem of bioterrorism, while avoiding measures that could increase
the threat. Until now, we have put the cart before the horse,
purchasing a few drugs and vaccines (that may in fact be unusable due
to problems that are only now being identified), without any overall
program to protect the Nation from the range of threats we face.
Instead, there has been great duplication of efforts by agencies with
overlapping responsibilities, but little attention to systematically
plugging the gaps in our preparedness.
NIAID was given a large amount of money in 2002 to allocate to
bioterrorism preparedness, and elected to use much of it to support
building new high containment laboratories around the country. Although
some additional capacity was probably needed, much of the additional
capacity appears at this stage to be superfluous. More worrisome than
wasteful, however, is the fact that the new labs will employ thousands
of scientists with new careers in bioterrorism, who will study
weaponizable pathogens, thus proliferating knowledge about these
pathogens. This could lend itself to serious blowback in the future. We
have no systematic mechanisms in the civilian sector to screen these
scientists and other new biodefense employees, nor have we the means to
prevent researchers from taking miniscule samples of pathogens out of
the lab, nor to follow their activities once they leave our research
centers. Nor do we have foolproof systems to maintain the security and
safety of the labs. An electrical failure with loss of generator
capacity at Plum Island, New York 2 years ago graphically demonstrated
that even redundant systems can fail, and that one may not always be
able to keep dangerous pathogens safety confined. It is simply not
possible to have a fail-safe system. Researchers can become infected
and bring their illness to the community; cultures thought to be dead
or attenuated are found to be virulent.
Plum Island was chosen for biodefense work decades ago because
there was no land link to Long Island or the U.S. mainland. This was a
powerful safety measure that we are now ignoring at our peril. There
cannot be a sufficient rationale for siting biodefense laboratories in
heavily populated areas, even if this makes attracting quality staff
easier. The hubris of assuming that nothing can go wrong does not augur
well for the scrupulous safety planning that should be taking place,
particularly in light of accidents at these very same labs in the
recent past. (Three researchers at Boston Medical Center developed
tularemia and one researcher at Fort Detrick developed glanders
recently as a result of working with the organisms; in each case, it
was not suspected until late that they were ill due to occupational
exposures).
How do we best get safe new drugs and vaccines to the population? I
would venture to say that when government has employed medical
therapies for political ends, rather than for a demonstrated medical
need, the strategy often backfires. Using public relations techniques
to create a need for treatment in the public's mind is another
dangerous strategy with a tendency to backfire, as the public learns to
mistrust the medical pronouncements of government. This probably
accounts for why we have a flu vaccine surplus today, despite what was
touted as a dangerous shortage several weeks ago.
The swine flu vaccine program of 30 years ago failed because
vaccine was made and Americans vaccinated due to a political program,
in the absence of an outbreak. In order to get rapid production of
vaccine by industry, the Federal Government assumed the liability for
vaccine-induced injuries, and paid for many cases of neurological
illness. Americans learned that Guillain-Barre Syndrome could be caused
by vaccines.
In 1998 the anthrax vaccine was rolled out as the first
immunization in a potentially large program of vaccinations to protect
the military from biowarfare threats. Here again the Federal
Government, in the person of the Secretary of the Army, indemnified the
manufacturer against all liability from adverse effects or product
failure. This measure was reportedly designed to avoid costs, but may
become quite costly, due to ongoing litigation about the vaccine's
safety and efficacy. The vaccine's license for prevention of inhalation
anthrax was removed in October 2004 by Judge Emmet Sullivan.
The ability to shift the costs of product indemnification by
Federal agencies probably works to make indemnification attractive.
Although it was the Army that indemnified the vaccine manufacturer
(reducing the manufacturer's need to produce a quality product)
soldiers who become disabled as a consequence of anthrax vaccination
are paid primarily by the Department of Veterans Affairs and/or Social
Security Disability. So far there has been little impact on the Army's
budget from its decision to use a poorly tested and manufactured
vaccine.
In late 2002 the Federal Government initiated the smallpox
immunization program, with plans to vaccinate, stepwise, 10 million
first responders and medical personnel. The manufacturer, Wyeth, had
turned over its smallpox vaccine stockpile to the Federal Government 2
decades ago, and it too received immunity from liability claims. Due to
a poor initial response by volunteers, Congress crafted a plan to
insure vaccine recipients against death or disability, with a maximum
payout per recipient of $262,100. However, despite this guarantee,
higher than expected rates of cardiac complications caused the pool of
volunteers to dry up. The civilian smallpox vaccine program withered on
the vine in late 2003, but mandatory military smallpox vaccinations
have continued, perhaps helped along by shifting the costs of the
programs's adverse medical consequences to other agencies.
In November 2004, FDA added a black box warning to the vaccine
label, limiting use to only those at high risk of smallpox, and
indicating that myocarditis was occurring approximately 100 times more
often than initially reported: one in every 145 vaccine recipients had
developed this complication in a clinical trial conducted by industry.
The military smallpox program continued nonetheless.
A historical lesson that industry may not want to acknowledge is
that when the removal of manufacturers' liability is sought and
obtained, the resulting products have usually been associated with
serious safety issues. And when the government assumes the liability,
it has a strong disincentive to perform appropriate scientific studies
that will identify and quantify the health risks of such products. Thus
we still lack reliable statistical data on the types and rates of
adverse reactions for anthrax vaccine. And despite CDC surveillance of
40,000 smallpox vaccine recipients, we remain in the dark about the
rates of vaccine complications, apart from myocarditis and skin
conditions.
The Food and Drug Administration used to be the preeminent agency
in the world for protecting citizens from bad drugs. Unfortunately,
this began to change about 10 years ago, spurred by two Congressional-
FDA initiatives: the Food and Drug Administration Modernization Act and
the Prescription Drug User Fee Act.
Encouraged by the Executive branch, FDA came to view industry as
its primary client, rather than the public, and focused more on rapid
drug approvals than on assuring safety and efficacy of new products.
Allowing direct-to-consumer advertising further damaged the agency's
reputation. This also made it harder for physicians to prescribe
medicines cost-effectively. Ignoring serious bacterial contamination in
2004 at flu vaccine manufacturer Chiron Corporation, FDA demonstrated a
willful failure to carry out its responsibility for assuring good
manufacturing practices.
Things have gone from bad to worse at FDA lately. The large number
of recent drug withdrawals, the continuing series of scandals involving
FDA's connivance with industry to hide serious adverse drug effects,
and widespread loss of trust--by its own employees--that the FDA can do
its assigned job grace the pages of our newspapers daily. The fact that
the American Medical Association recently recommended that assessment
of drug safety be performed by a separate agency confirms that the
credibility of FDA has dropped to a critical level, and serious reforms
are way overdue.
It is this flawed, unreliable FDA that is now charged with
approving new drugs and vaccines for bioterrorism: products likely to
receive less testing, using fast-track procedures, than for standard
drug approvals. This FDA also approves the use of unlicensed,
investigational products under certain circumstances, and has just done
so for the military with anthrax vaccine.
Given FDA's ongoing credibility problems, the procedures currently
in place to assure that American citizens obtain safe and effective
products to prevent and treat diseases due to bioterrorism are
inadequate. We are talking, after all, about drugs that cannot be
tested for efficacy in humans: potentially the entire Nation could
receive such drugs or vaccines that have had only rudimentary human
testing. And animal testing is uniformly acknowledged to be inadequate
to assess human safety.
Americans cannot currently rely on FDA to guarantee quality
manufacturing, testing, safety and effectiveness of these products.
Because these drugs are likely to be used all at once, i.e., the entire
Nation might be treated during the same week, we will have only very
limited information about the drugs' side effects and effectiveness
when the decision to use them is made. We will not have acquired the
clinical familiarity and longer term data that accrue over the 1st year
or 2 of a new drug's use, and upon which most physicians rely.
As a clinician, I consider this entirely unacceptable. Such drugs
need more attentive oversight than ordinary drugs, not less, before
they are approved for use. A reliable track record must exist before I
can prescribe a drug or vaccine. Because all drugs cause adverse
reactions in some recipients, and the administration of every drug
involves a risk-benefit calculation, their appropriate use requires
care and skill. No one should decide to prescribe for the Nation
without the availability of reliable information on the drug to be
used. Yet current law permits the Secretary of HHS to do so, even if
that person has no medical training. He may consult with the FDA
Commissioner; but the current Acting Commissioner is a veterinarian.
HHS will bear no financial liability if the drug turns out to be more
dangerous than anticipated.
Of course industry needs incentives in order to develop and produce
useful products. I submit that current patent protections for industry
should be changed. Why should the clock start ticking on a drug patent
the day the patent is issued, even though this is years before FDA
approval is obtained and the product can be manufactured? The ticking
clock forces FDA to eschew safety considerations for speed.
A preferable alternative would be, for example, to extend patent
protection based on the date of FDA licensure. This would give FDA and
the manufacturer breathing space, allow for clinical safety trials of
longer duration, and give the manufacturers a reasonable incentive. In
order to speed new drug development, the length of patent extension
could also become a function of how quickly the new product is
developed. Another advantage to this proposal is that it would remove
the incentive manufacturers now have to rush out drugs before they are
well understood.
Other incentives for industry have been discussed elsewhere, but
should not be used if they are associated with significant safety
risks. Industry may wish to use certain products, such as currently
unlicensed vaccine adjuvants, in vaccines designed for bioterrorism
because they improve efficacy. Possibly this back door approach would
help them move these adjuvants toward licensure. However, given the
known risk of these products to induce autoimmune disorders in
susceptible recipients, bioterrorism must not become the excuse to
initiate their widespread use in humans.
My final point is that prevention of bioterrorism should be the top
priority of Bioshield legislation. Because we cannot afford to protect
against all potential pathogens, because we cannot even predict the
potential pathogens we might face, and because the minute size of
microorganisms makes bioagent proliferation extremely easy, it should
be clear to all that we will never be able to purchase adequate
protection from bioterrorism, no matter how many resources we expend.
Therefore, finding ways to maximize international cooperation in the
development of countermeasures, in inspections of biological research
and manufacturing facilities, and in preventing the proliferation of
bioweapons scientists should receive our full attention and resources.
It is hard to understand why successive U.S. administrations have
failed to embrace the value of this approach, and why diplomatic
measures, such as strengthening the verification provisions of the
Biological Weapons Convention, have not received strong support from
the U.S. government. This is a low cost approach that can be undertaken
in tandem with all the other measures designed to boost protection for
our population. Although industry had reservations about inspections in
the past, because of the potential loss of trade secrets, PHaRMA now
supports strengthening the Biological Weapons Convention with
inspections and other efforts.
The clock is ticking for our species and planet. We can throw money
scattershot at this problem and move on, or we can give it the
prolonged attention and effort it deserves, and ask some of our
strongest scientists, engineers, and statesmen to help think through
the overall problem of readiness and appropriate preparation. If we are
to take the threat seriously, we must maximize our resources on the
local and global levels. So far we have not done so. Thank you.
______
The Military Vaccine Education Center,
Missoula, MT 59807,
February 7, 2005.
Hon. Jeff Bingaman,
Subcommittee on Bioterrorism and Public Health Preparedness,
U.S. Senate,
Washington, D.C. 20510.
RE: Feb. 8, 2005 Hearing on Biodefense: The Next Steps
To Members of the Committee: My name is Kathryn Hubbell, and I am
writing as President of both the Military Vaccine Education Center,
Inc. (www.milvacs.org), a networking, resource and referral center for
troops and veterans, and the Military Vaccine Action Committee, L.L.C.,
a ``non-connected PAC'' (www.mvacpac.org).
I am hoping these remarks and the accompanying timeline will prompt
you to learn from the mistakes--the outright disasters--that have
occurred with the military's mandatory bioterrorism vaccines, so that
as you move forward discussing ways to help the public, these same
mistakes will be replaced by sound policy, medically stringent
procedures, and proper protocol.
I am very tempted to relate to you the heartbreaking letters we
receive on a daily basis from service members and veterans, describing
their extreme illnesses as a result of the anthrax vaccine (and now of
the smallpox vaccine); the way they are insulted and humiliated by
their chains of command, who have been taught that there is no relation
between these illnesses and the vaccines; their years of struggle to
obtain any kind of medical benefits, a struggle which too often results
in the loss of their homes, cars, jobs and marriages; and finally,
their ensuing struggle to maintain a sense of dignity in the face of
extreme disability, and to have faith that they still have something to
contribute to their country.
But let's not go there. Many of the ill have already written to
you, and you might be tempted to think ``This is terrible, but these
are isolated incidents.''
So I would like to speak in a different language, one that looks at
the larger picture and does not dwell on individual sadness. I would
like to talk about numbers, processes, and finances; and finally, about
alternative solutions, solutions which are badly needed because what's
been done up until now for our troops has backfired badly. We should
review the past steps and ask pertinent questions in order to determine
what the next steps are.
Here are some facts and concepts which need serious questioning:
The anthrax vaccine label itself--mandated by the FDA in
2002--admits to a systemic averse reaction rate of between 5 percent
and 35 percent--where previously, the DOD claimed it was a mere .02
percent (http://www.bioportcorp.com/AnthraxVaccine/insert/
avainsert.asp). Since then, the GAO (Government Accounting Office) has
come out with a new report estimating the systemic adverse reaction
rate is probably as high as 85 percent.\1\ In addition, it is known
that women have a much greater adverse reaction rate than men.\2\
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\1\ Government Accounting Office; 2002; Anthrax Vaccine: GAO's
survey of Guard and Reserve Pilots and Aircrew; GAO-22-445, p.22.
\2\ Ibid. p.9.
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Questions: Why would the Department of Defense risk losing over a
third of its troop strength to this highly reactive, questionable
vaccine?
Are we not to believe that our troops are stretched quite thin all
over the world?
How many of our fine men and women in uniform have left the service
because of the anthrax vaccine? This is more of a rhetorical question,
because many service members leaving active duty simply didn't give the
real reason. My son was one of them. He still misses the Air Force; but
he misses his full health even more.
We've had nearly 1,600 service members killed in Iraq, and
several thousand have returned home wounded. But nearly 17,000 have
been medically evacuated out of Iraq due to non-combat causes.\3\
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\3\ United Press International, 2004: Pentagon not listing 17,000
war casualties. (http://www.washtimes.com/upi-breaking/20040915-052239-
8792r.htm).
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Is this a normal figure in time of war? Is it acceptable? And
exactly what are those non-combat causes? Who has the records?
How much is it costing the VA and the Vaccine Health Care Centers
to treat these sick troops? Is it cost-effective to wait until they get
sick and are medical-boarded out of the service, rather than provide
them with protective gear and antibiotics so they can stay in and serve
their country as they so much want to do?
The 2002 GAO also stated that of the Guard and Reserve
units forced to take the vaccine, at least 18 percent of the pilots
resigned or obtained transfers out of their units rather than take the
vaccine and jeopardize their civilian flying careers.\4\
---------------------------------------------------------------------------
\4\ Government Accounting Office; 2002; Anthrax Vaccine: GAO's
survey of Guard and Reserve Pilots and Aircrew; GAO-22-445, p.9.
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Questions: How much does it cost to train an F-16 pilot?
How much does it cost to replace a fighter jet if the pilot
suddenly suffers an attack of vertigo--one of the most common anthrax
vaccine reactions--and has to bail out?
How many pilots are we short right now?
Walter Reed Vaccine Healthcare Center saw over 1,000
patients and consulted with more than 139,000 individuals via phone/
email as a result of problems with the anthrax/smallpox vaccine in 2003
alone.\5\
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\5\ Rupple, David; 2004; U.S. Army Provides No Funds for Vaccine
Care Centers; Global Security Newswire, May 18, 2004; (http://nti.org/
d%5Fnewswire/issues/2004/5/18/
b047b91a%2Dbaae%2D4469%2Da369%2Dce894037d5a1.html).
---------------------------------------------------------------------------
Questions: Why is funding for the Walter Reed Vaccine Healthcare
Center constantly jeopardized?
How will we fund the four new Vaccine Healthcare Centers that are
needed and proposed, when we can barely take care of the ones we've
got?
If there is no connection between these illnesses and the anthrax
and smallpox vaccines, why are the current Vaccine Healthcare Centers
needed at all--let alone requesting expansion into other cities and
States?
The anthrax vaccine was never licensed for use against
aerosolized anthrax. Despite the FDA's ``finalizing the rule'' for the
anthrax vaccine in December of 2003, just 8 days after Judge Emmett
Sullivan declared it illegal, the Vaccine in its current form was never
meant to be used against aerosolized anthrax.\6\
---------------------------------------------------------------------------
\6\ Rempfer, T; Dingle, R.; Connecticut Air National Guard, 2001 An
analysis of the flawed process behind the development of the anthrax
vaccine, pp.1-2.
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Question: The FDA and the pharmaceutical industry are currently
under intense scrutiny--and facing lawsuits--for drugs freely used off-
label, and/or drugs whose dangers were known, such as Vioxx, but
reached the open market, for years anyway. There are now consequences
to pay for both Merck, the manufacturer of Vioxx, and the FDA.
If these standards and consequences are good for our civilians, why
do we not uphold such standards for our troops? Are they somehow made
of totally different genetic material than the families from which they
came?
The anthrax vaccine was originally licensed based on data
from a different vaccine. The only safety/efficacy study ever done on
human beings was done on that different vaccine.\7\
---------------------------------------------------------------------------
\7\ Ibid.
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The FDA and DOD have also previously admitted that efficacy based
on animal studies against inhalation is problematic because no proven
correlate of immunity between animals and humans exists for anthrax
infection.
Question: Again, why are standards lowered for our troops? Why are
the normal safety standards and protocols consistently bypassed when it
comes to our troops?
The anthrax vaccine protocol originally called for 3 shots
only; the change to a series of 6 shots with annual boosters was done
with no foundation in research or fact. The label was actually changed
to reflect the protocol then in practice; the protocol was not dictated
by instructions on the label. In 1985, a review panel ``also found the
dosage of the anthrax vaccine to be incorrect, and recommended a
correction to the labeling to only 3 shots.'' \8\
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\8\ Rempfer, T; Dingle, R.; Connecticut Air National Guard, 2001:
Time Line: Development and use of the Anthrax Vaccine and the Anthrax
Vaccine Immunization Program.
---------------------------------------------------------------------------
Question: Why is it that no one went back to the source documents
to understand what really happened? The problem is that the ``sound
bites'' and convenient answers get repeated so often that they are
finally accepted as the truth.
There have been no long-term studies done of reactions to
the anthrax vaccine.\9\
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\9\ Chan, K.C., 1999; Summary of GAO's findings on the safety and
efficacy of the anthrax vaccine. Letter to Hon. Steve Buyer. Government
Accounting Office, NSAID-00-54R.
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The bottom-line question for all of the points we have just brought
up is this: Why have such shoddy processes and practices been allowed?
Where were the standards for the development process and the follow-up?
Why has the FDA not enforced its own rules and procedures?
``Researchers at Johns Hopkins University said Wednesday
that early detection--and not a pre-exposure vaccination--is the key to
limiting an outbreak of anthrax.'' (http://www.cnn.com/2004/HEALTH/12/
15/anthraxdetect/) Dec. 14, 2004.
There are a number of anthrax early-detection kits and
products on the market. (example: http://osborn-scientific.com/PDF/
anth data OSG 0411.pdf). In addition, antibiotics and protective
garments, masks and filters are readily available.
Question: Why are funds being directed at vaccine instead of being
used for better detection equipment and better protective gear for our
troops?
The military has a tendency to administer multiple
vaccines in one day--smallpox, anthrax, the Hepatitus B, and more.
Nearly 2 years ago, a young Army Reservist named Rachel Lacy died
within a month of receiving this assault upon her immune system.\10\
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\10\ Dept. of Defense, 2003; Panel Issues Report on Vaccine Adverse
Event Case. (http://www.anthrax.osd.mil/media/pdf/
safetypanelQA.pdfhttp://www.anthrax.osd.mil/media/pdf/
safetypanelQA.pdf).
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Questions: Why are non-medical commanders in charge of
administering this program, instead of military physicians? Is there no
one in the military medical establishment who understands that the
human body cannot accommodate such an assault without severe problems?
Here's the bottom line: If the anthrax vaccine was a civilian
vaccine, it would have been pulled from the market years ago, and the
resulting lawsuits would have bankrupted the manufacturer.
We do not want to see these travesties perpetuated on the general
public. At the same time, we know that it is only when the public is
subjected to the same investigational drugs that a public outcry will
finally force accountability over these issues.
My understanding is that you are a subcommittee dealing with
bioterrorism issues and with public health. If you want to protect the
public, do not treat them the way our service members have been
treated. Our men and women in the military have long served as
unwitting medical guinea pigs.\11\
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\11\ Committee on Veterans' Affairs, 1994: Is Military Research
Hazardous To Veterans' Health? Lessons Spanning Half A Century. U.S.
Congress. (http://www.datafilter.com/mc/
militaryHumanExperimentationReport94.html).
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Vaccines, at their best, still carry a risk for a certain
percentage of the population. As we move into an era of more--and more
difficult--bioterrorism vaccines, the terrible lessons of the past must
guide our actions. We cannot afford to decimate our military due to
unproven, unsafe, investigational new drugs. Nor will the general
public stand for such results.
Please consider the following:
1. Demand a full explanation of the exact anthrax threat that
constitutes the ``emergency'' recently declared by Tommy Thompson of
Health & Human Services.
2. If the public is definitely facing an anthrax threat, then the
triple-pronged approach--better detection equipment, antibiotics and
protective clothing--is the one increasingly recommended.
3. If the public genuinely needs an anthrax vaccine, or a smallpox
vaccine--or a vaccine against ricin or anything else--then a new
vaccine must be developed that adheres to the strictest of sound
scientific and medical principles and processes. Because it takes years
to run clinical trials, people must be given informed consent
documents, as they were after the 9/11 attacks--the same documents our
troops have never been given, but to which they are constitutionally
entitled.
4. If new smallpox and other bioterrorism vaccines are going to be
made available to members of our armed forces as well as civilians,
there must be a better protocol in place for administering these
vaccines. Giving a person multiple shots in one day is against every
form of medical protocol for vaccinations that there is.
5. We are against providing complete legal protection for those
manufacturing these vaccines, because we have seen what it has done to
members of the armed services. They have no recourse to sue for their
injuries and illnesses due to a 1950 body of law called the Feres
Doctrine.\12\ We are convinced that Feres Doctrine was not meant to
pave the way for unregulated medical experimentation upon members of
the armed services--but despite its good intent, that's exactly the
result. We need to be able to hold vaccine manufacturers as well as the
FDA completely accountable for the policies and procedures by which
these vaccines are developed and come to market. Giving them complete
immunity merely because vaccines are not a high profit-producing area
for a pharmaceutical company will result in the same sloppy procedures,
carelessness, haste, and desire to improve the bottom line that we have
seen in the development and administration of the anthrax vaccine.
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\12\ http://usmilitary.about.com/library/milinfo/blferes.htm.
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If you doubt this, consider that Vioxx was legally approved for
placement on the market by the FDA. Consider that Merck had warnings
about the dangers of Vioxx as early as 1996, and was able to market the
drug anyway; in fact, the FDA apparently pressured a researcher to
withhold evidence about the drug's dangers.\13\
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\13\ Associated Press, 2005: Journal Releases Vioxx Study. CNN.com
at (http://www.cnn.com/2005/HEALTH/01/25/vioxx.study.ap/).
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All this was done working with our current system of regulation by
the FDA, and with our current system of supposedly holding drug
manufacturers accountable. The bottom line for Merck was that Vioxx
accounted for over 10 percent of its gross earnings each year, a $2.5
billion dollar product.\14\ It's far too tempting, given those figures,
to ignore or hide warnings and proceed toward depositing that check in
the bank.
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\14\ (Merck & Co., Annual report, 2003).
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Vaccine manufacturers and health care providers want protection
without accountability or at best with very limited accountability--
except in case of violating standard medical procedures when
administering the vaccine, or in cases of gross negligence.
But, as you have just seen, the military has consistently violated
standard medical procedures when administering the anthrax vaccine,
and, in conjunction with the FDA, has shown gross negligence in
development of the anthrax vaccine.
6. Although we are reluctant to suggest yet more government
bureaucracy, we are convinced that a separate body might provide more
stringent oversight of the procedures for developing and administering
vaccines than does the FDA. We need an independent body that is not so
closely aligned with the pharmaceutical industry, and is not beholden
to the industry in any way.
Finally, I have taken the rather extraordinary step of attaching a
full timeline, documented with footnotes and references, describing the
flawed, careless and deceitful development of the anthrax vaccine, a
process in which the Department of Defense, BioPort, Inc., and the FDA
all took part. If the vaccines we want to manufacture in the future
cannot be done in any better way than this, our country is in serious
trouble. I thank you for your time.
Sincerely,
Kathryn D. Hubbell,
President, Military Vaccine Education Center, Inc.,
President, Military Vaccine Action Committee, L.L.C.
Attachment: Time Line: Development and use of the Anthrax Vaccine
and the Anthrax Vaccine Immunization Program, Compiled by Major Thomas
Rempfer and Lt. Col. Russell Dingle, Connecticut Air National Guard.
[Whereupon, at 12:32 p.m., the subcommittee was adjourned.]