[House Hearing, 109 Congress]
[From the U.S. Government Publishing Office]
ELUSIVE ANTIDOTES: PROGRESS DEVELOPING CHEMICAL, BIOLOGICAL,
RADIOLOGICAL AND NUCLEAR COUNTERMEASURES
=======================================================================
HEARING
before the
SUBCOMMITTEE ON NATIONAL SECURITY,
EMERGING THREATS, AND INTERNATIONAL
RELATIONS
of the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED NINTH CONGRESS
FIRST SESSION
__________
JUNE 14, 2005
__________
Serial No. 109-83
__________
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.gpoaccess.gov/congress/
index.html
http://www.house.gov/reform
______
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COMMITTEE ON GOVERNMENT REFORM
TOM DAVIS, Virginia, Chairman
CHRISTOPHER SHAYS, Connecticut HENRY A. WAXMAN, California
DAN BURTON, Indiana TOM LANTOS, California
ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York
JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York
JOHN L. MICA, Florida PAUL E. KANJORSKI, Pennsylvania
GIL GUTKNECHT, Minnesota CAROLYN B. MALONEY, New York
MARK E. SOUDER, Indiana ELIJAH E. CUMMINGS, Maryland
STEVEN C. LaTOURETTE, Ohio DENNIS J. KUCINICH, Ohio
TODD RUSSELL PLATTS, Pennsylvania DANNY K. DAVIS, Illinois
CHRIS CANNON, Utah WM. LACY CLAY, Missouri
JOHN J. DUNCAN, Jr., Tennessee DIANE E. WATSON, California
CANDICE S. MILLER, Michigan STEPHEN F. LYNCH, Massachusetts
MICHAEL R. TURNER, Ohio CHRIS VAN HOLLEN, Maryland
DARRELL E. ISSA, California LINDA T. SANCHEZ, California
GINNY BROWN-WAITE, Florida C.A. DUTCH RUPPERSBERGER, Maryland
JON C. PORTER, Nevada BRIAN HIGGINS, New York
KENNY MARCHANT, Texas ELEANOR HOLMES NORTON, District of
LYNN A. WESTMORELAND, Georgia Columbia
PATRICK T. McHENRY, North Carolina ------
CHARLES W. DENT, Pennsylvania BERNARD SANDERS, Vermont
VIRGINIA FOXX, North Carolina (Independent)
------ ------
Melissa Wojciak, Staff Director
David Marin, Deputy Staff Director/Communications Director
Rob Borden, Parliamentarian
Teresa Austin, Chief Clerk
Phil Barnett, Minority Chief of Staff/Chief Counsel
Subcommittee on National Security, Emerging Threats, and International
Relations
CHRISTOPHER SHAYS, Connecticut, Chairman
KENNY MARCHANT, Texas DENNIS J. KUCINICH, Ohio
DAN BURTON, Indiana TOM LANTOS, California
ILEANA ROS-LEHTINEN, Florida BERNARD SANDERS, Vermont
JOHN M. McHUGH, New York CAROLYN B. MALONEY, New York
STEVEN C. LaTOURETTE, Ohio CHRIS VAN HOLLEN, Maryland
TODD RUSSELL PLATTS, Pennsylvania LINDA T. SANCHEZ, California
JOHN J. DUNCAN, Jr., Tennessee C.A. DUTCH RUPPERSBERGER, Maryland
MICHAEL R. TURNER, Ohio STEPHEN F. LYNCH, Massachusetts
JON C. PORTER, Nevada BRIAN HIGGINS, New York
CHARLES W. DENT, Pennsylvania
Ex Officio
TOM DAVIS, Virginia HENRY A. WAXMAN, California
Lawrence J. Halloran, Staff Director and Counsel
Kristine Fiorentino, Professional Staff Member
Robert A. Briggs, Clerk
Andrew Su, Minority Professional Staff Member
C O N T E N T S
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Page
Hearing held on June 14, 2005.................................... 1
Statement of:
Hanna, Dr. Michael G., Jr., Chief Scientific Officer,
Intracel; and Dr. James H. Davis, executive vice president
and general counsel, Human Genome Sciences, Inc............ 95
Davis, Dr. James H....................................... 102
Hanna, Dr. Michael G., Jr................................ 95
Klein, Dale, Assistant to the Secretary of Defense for
Nuclear, Chemical and Biological Defense Programs,
Department of Defense; Dr. Anthony S. Fauci, Director,
National Institute of Allergy and Infectious Diseases,
National Institute of Health; Stewart Simonson, Assistant
Secretary for Public Health, Emergency Preparedness,
Department of Health and Human Services; John Vitko, Jr.,
Director, Biological Countermeasures Portfolio, Science and
Technology Directorate, Department of Homeland Security;
and Ronald J. Saldarini, Scientific Consultant, Institute
of Medicine................................................ 5
Fauci, Dr. Anthony S..................................... 21
Klein, Dale.............................................. 5
Saldarini, Ronald J...................................... 74
Simonson, Stewart........................................ 48
Vitko, John, Jr.,........................................ 65
Letters, statements, etc., submitted for the record by:
Davis, Dr. James H., executive vice president and general
counsel, Human Genome Sciences, Inc., prepared statement of 104
Fauci, Dr. Anthony S., Director, National Institute of
Allergy and Infectious Diseases, National Institute of
Health, prepared statement of.............................. 23
Hanna, Dr. Michael G., Jr., Chief Scientific Officer,
Intracel, prepared statement of............................ 98
Klein, Dale, Assistant to the Secretary of Defense for
Nuclear, Chemical and Biological Defense Programs,
Department of Defense, prepared statement of............... 8
Kucinich, Hon. Dennis J., a Representative in Congress from
the State of Ohio, prepared statement of................... 121
Ruppersberger, Hon. C.A. Dutch, a Representative in Congress
from the State of Maryland, prepared statement of.......... 125
Saldarini, Ronald J., Scientific Consultant, Institute of
Medicine, prepared statement of............................ 76
Sanders, Hon. Bernard, a Representative in Congress from the
State of Vermont, prepared statement of.................... 129
Shays, Hon. Christopher, a Representative in Congress from
the State of Connecticut, prepared statement of............ 3
Simonson, Stewart, Assistant Secretary for Public Health,
Emergency Preparedness, Department of Health and Human
Services, prepared statement of............................ 50
Vitko, John. Jr., Director, Biological Countermeasures
Portfolio, Science and Technology Directorate, Department
of Homeland Security, prepared statement of................ 67
ELUSIVE ANTIDOTES: PROGRESS DEVELOPING CHEMICAL, BIOLOGICAL,
RADIOLOGICAL AND NUCLEAR COUNTERMEASURES
----------
TUESDAY, JUNE 14, 2005
House of Representatives,
Subcommittee on National Security, Emerging
Threats, and International Relations,
Committee on Government Reform,
Washington, DC.
The subcommittee met, pursuant to notice, at 2:06 p.m., in
room 2154, Rayburn House Office Building, Hon. Christopher
Shays (chairman of the subcommittee) presiding.
Present: Representatives: Shays, Marchant, Platts, Duncan,
Turner, Kucinich, Van Hollen, Ruppersberger, and Higgins.
Staff present: Lawrence Halloran, staff director and
counsel; Kristine Fiorentino, professional staff member; Robert
A. Briggs, clerk and professional staff member; Andrew Su,
minority professional staff member; and Jean Gosa, minority
assistant clerk.
Mr. Shays. The Subcommittee on National Security, Emerging
Threats, and International Relations' hearing entitled,
``Elusive Antidotes: Progress Developing Chemical, Biological,
Radiological and Nuclear Countermeasures,'' is called to order.
First, let me apologize for keeping you waiting. It is not
my practice to keep any of you waiting, you have very important
things to do.
More than a decade after U.S. armed forces faced exposure
to Saddam's chemical arsenal and 4 years after the anthrax
attacks here at home, the development of medical
countermeasures against unconventional weapons remains an
elusive goal. A multitude of Federal offices and programs
pursue separate, shifting, often competing priorities without
disciplined linkage to a strategy to address the most pressing
threats.
By one count last year, 75 high level Federal officials in
seven Cabinet departments were responsible for biodefense
policies, program execution or budgets. The Department of
Health and Human Services, the Department of Homeland Security,
the Department of Defense, the Department of Agriculture, the
Department of Commerce, the Department of State and the
Environmental Protection Agency all have some responsibility
for the Nation's defenses against chemical, biological,
radiological assaults.
To date, this littered landscape has not been fertile soil
for the growth of needed countermeasures against the threats
posed by the pathogens, toxins, chemicals and isotopes known to
be within the grasp of terrorists. Five years ago, the Defense
Science Board saw the need for 57 vaccines, drugs and
diagnostics to meet the threat. Today, we have just two of
those in hand, both based on old technologies.
The Department of Defense specifically, the Joint Vaccine
Acquisition Program, offers a sadly illustrative example of the
difficulties plaguing the broader Federal effort. A 2004 study
by the Institute of Medicine found the DOD biodefense program
fragmented and often prey to competing priorities. Launched in
1997 with $322 million, the JVAP has spent that much and more.
Yet lists of JVAP ``accomplishments'' provided to the
subcommittee include just one recently licensed therapeutic, no
completed vaccines and two target vaccine programs terminated
after significant expenditures.
Without question, countermeasure development is an
expensive, technically challenging process that cannot be
forced to yield results on an arbitrary timetable. The current
approach lacks cohesiveness and urgency. Those trying to
advance medical countermeasures face a torturous labyrinth of
Federal fiefdoms into which billions disappear, yet very few
antidotes have yet to emerge.
In October 2001, this subcommittee held a field hearing on
the development of medical countermeasures against biological
warfare agents. We met across the street in the Department of
Health and Human Services headquarters building, because the
Capitol complex was closed for anthrax testing and remediation.
We were told aggressive steps were being taken to defend both
civilian and military personnel against anthrax, smallpox,
botulinum toxin and other likely threats.
Today we find the biodefense pipeline still producing
little more than promises of cures to come. Project BioShield
represents an essential mechanism to streamline the
countermeasure development end game, acquisition, but it can do
little to accelerate the glacial process of moving vaccines,
drugs and other therapies from basic research to final
formulation and licensure. That is a function of leadership,
coordination and strict adherence to a threat-based strategy.
We asked our witnesses to describe how greater focus and
momentum can be brought to this complex process. They bring
world class credentials and unmatched experience to our
discussion and we look forward to their testimony and we thank
them for their presence here today.
At this time, the Chair would recognize Mr. Marchant.
[The prepared statement of Hon. Christopher Shays follows:]
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Mr. Marchant. I don't have any opening statement. I am
happy to be here.
Mr. Shays. Thank you. I appreciate the gentleman's
participation and his help with the work of this subcommittee.
Let me now take care of some business. I ask unanimous
consent, given that we have a quorum, that all members of the
subcommittee be permitted to place an opening statement in the
record and the record remain open for 3 days for that purpose.
Without objection, so ordered.
I ask further unanimous consent that all witnesses be
permitted to include their written statements in the record and
without objection, so ordered.
At this time, I will introduce the first panel. We have Dr.
Dale Klein, Assistant to the Secretary of Defense for Nuclear,
Chemical and Biological Defense Programs, Department of
Defense; Dr. Anthony S. Fauci, Director, National Institute of
Allergy and Infectious Diseases, National Institute of Health;
the Honorable Stewart Simonson, Assistant Secretary for Public
Health, Emergency Preparedness, Department of Health and Human
Services; Dr. John Vitko, Jr., Director, Biological
Countermeasures Portfolio, Science and Technology Directorate,
Department of Homeland Security; and Dr. Ronald J. Saldarini,
Scientific Consultant, Institute of Medicine.
As is the custom, we swear our witnesses and I would ask
you to stand.
[Witnesses sworn.]
Mr. Shays. We prefer that your testimony be closer to 5
minutes but we will roll it over for another 5 minutes and
would like you to stop within that time because we have a
number of panelists.
Dr. Klein.
STATEMENTS OF DALE KLEIN, ASSISTANT TO THE SECRETARY OF DEFENSE
FOR NUCLEAR, CHEMICAL AND BIOLOGICAL DEFENSE PROGRAMS,
DEPARTMENT OF DEFENSE; DR. ANTHONY S. FAUCI, DIRECTOR, NATIONAL
INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL
INSTITUTE OF HEALTH; STEWART SIMONSON, ASSISTANT SECRETARY FOR
PUBLIC HEALTH, EMERGENCY PREPAREDNESS, DEPARTMENT OF HEALTH AND
HUMAN SERVICES; JOHN VITKO, JR., DIRECTOR, BIOLOGICAL
COUNTERMEASURES PORTFOLIO, SCIENCE AND TECHNOLOGY DIRECTORATE,
DEPARTMENT OF HOMELAND SECURITY; AND RONALD J. SALDARINI,
SCIENTIFIC CONSULTANT, INSTITUTE OF MEDICINE
STATEMENT OF DALE KLEIN
Dr. Klein. Chairman Shays and members of the subcommittee,
I am honored to appear before your subcommittee again to
address your questions regarding the Department's efforts to
develop and acquire countermeasures to chemical, biological,
radiological and nuclear threats. As you indicated, I am the
Assistant to the Secretary of Defense for Nuclear, Chemical and
Biological Defense Programs.
Today, I will address the Department's defense process to
identify, prioritize, develop and acquire countermeasures to
the threats we face today and future threats. I will also
provide an update on some of the accomplishments of the medical
research program and the Joint Vaccine Acquisition Program.
Finally, I will highlight some of our interagency cooperative
efforts and following my comments, I welcome questions the
subcommittee might have and I will do the best I can to answer
them.
In accordance with congressional authority, I serve as the
focal point, overseeing the Department's chemical and
biological defense research, development and acquisition
programs. The Secretary of Defense recently provided direction
to enhance the chemical and biological defense posture. The
resulting study generated several options for increased
investment based on these new requirements and accompanying
risk.
Based on the study findings, senior leaders agreed to
increase the investment for WMB countermeasures by $2.1 billion
for the fiscal years 2006-2011. The increase included $1.3
billion for Chemical and Biological Defense Program. This
investment strategy begins in fiscal year 2006 with $1.5
billion for the President's budget request.
In addition to this study, the Director of Program Analysis
and Evaluation identified an additional $100 million in fiscal
year 2006 for the Chemical and Biological Defense Program to
address biological warfare and medical countermeasure
initiatives. These medical countermeasure initiatives will
apply transformational approaches which leverage our genomics,
proteomics consistent biology data exploitation.
The Chemical and Biological Defense Program has made
progress in several areas of medical defense. In 2003, the
first successful application of the new animal efficacy rule
occurred with Food and Drug Administration approval of
pyridostigmine bromide to increase survival exposure to soman
nerve agent poisoning.
In March 2005, a contract award was made for development of
a chemical agent bioscavenger for a pre or post-exposure
treatment of nerve agent exposure. In February of this year,
the FDA approved the DOD Vaccinia Immune Globulin used to treat
adverse events following smallpox immunization. In early 2005,
clinical trials began for both a multivalent botulinium vaccine
for stereotypes A and B and a plague vaccine. In July clinical
trials will begin for a Venezuelan Equine Encephalitis vaccine.
The DOD Chemical and Biological Defense Program activities
are informally coordinated with the Department of Health and
Human Services. Stewart Simonson and I meet on a regular basis
with the National Institute of Allergy and Infectious Diseases
with Dr. Fauci and the Centers for Disease Control and
Prevention.
DOD and the DHS are currently working on an interagency
agreement regarding cooperation on medical countermeasure
development. It is important to note that some of the medical
countermeasures currently being developed through NIAID for the
national stockpile have their technology bases and programs
which initially began in the Department of Defense. Examples of
this are the next generation anthrax vaccine and self-culture
derived smallpox vaccine.
A critical aspect of interagency coordination is DOD's
support for Project BioShield. The first product that DOD may
be able to transition to the Department of Health and Human
Services under Project BioShield is a plasma-derived,
bioscavenger for pre and post-exposure treatment of nerve agent
exposure. The DOD has awarded an initial contract for a Phase I
clinical trial at which time DHHS would be expected to assume
advanced development through FDA licensure under the BioShield
authority.
The joint project manager for the Chemical and Biological
Medical System is responsible for systems acquisition,
production and medical countermeasures against chemical and
biological agents, including the Joint Vaccine Acquisition
Program. In February of this year, the Under Secretary of
Defense for Acquisition Technology and Logistics provided you
with a detailed update on the JVAP acquisition program.
The Chemical and Biological Events Program budget provides
a balanced investment strategy which includes the procurement
of capabilities to protect U.S. forces in the near term,
investment in advanced development to protect U.S. forces in
the mid term and investment in the science and technology base
to protect U.S. forces in the far term and beyond.
As we look to the future, our main concern is a
bioengineered threat to our men and women in uniform. Our main
task continues to be to provide the best technology to the war
fighter in the most expeditious and efficient manner possible.
Therefore, my office will continue to focus on providing the
technology necessary to counter the threats posed by chemical
and biological agents, especially the biological agents.
Thank you for the opportunity to address these issues and I
will attempt to answer any questions and concerns the committee
might have.
[The prepared statement of Dr. Klein follows:]
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Mr. Shays. Thank you, Dr. Klein.
Dr. Fauci.
STATEMENT OF DR. ANTHONY S. FAUCI
Dr. Fauci. Thank you for giving me the opportunity to
discuss with you this afternoon the NIH biomedical research
effort in the development of countermeasures against three
major threats, biological, mainly microbes and toxins;
radiologic and nuclear countermeasures as well as chemical
countermeasures.
We began this endeavor over 3 years ago with the biological
and the medical countermeasures including radiologic, nuclear
and chemical based on the fundamental basic scientific approach
that has been adapted at the NIH for decades in our research in
other areas. This includes most recently an expansion of the
research capacity, both intellectual capacity of individuals
involved as well as physical structure and laboratories. All of
these are directed at the development of countermeasures in the
form of diagnostics, vaccines and therapeutics.
The greatest success thus far has been in an area in which
we have had decades of experience in confronting emerging and
reemerging infectious diseases at our NIH programs. In the end
of 2001 and early 2002, following the anthrax attacks, we
developed a comprehensive, strategic plan and a research agenda
for Category A as well as Category B and C agents. In addition,
we have developed and published now for your perusal the
progress reports for the Category A agents and most recently,
we have included the progress reports for the Category B and C
agents.
I would like to spend just a moment or two summarizing some
of these accomplishments that have occurred over the past 3
years. First, in the arena of smallpox, you may recall right
after the anthrax attack when we examined our stockpile, we had
about 15,000-18,000 doses which with dilution brought us up to
90,000. Now, with the techniques that were developed and Dr.
Klein just mentioned, we have over 300 million doses of
smallpox. In addition, we are working on clinical trials in the
next generation, safer, modified vaccinia Ankara as well as
antiviral drugs against smallpox.
As was mentioned, the anthrax situation is based on
research that is involved in the recombinant protective antigen
which has now been contracted for the stockpile through Project
BioShield. In addition, we are developing monoclonal and
polyclonal antibodies. We have success with Ebola. The Ebola
vaccine developed at NIH has proved 100 percent effective in
monkeys in protecting them from a challenge. We have just
completed a Phase I trial in humans showing it to be safe and
immunogenic. Botulism toxin, we are accelerating the
development of antibodies, particularly monoclonal antibodies
and influenza, which is a Category C agent, we are now well
into clinical trials for the H-5 N-1 pandemic flu threat that
we now face in Asia. This work is built upon the decades of
experience with emerging and a reemerging microbes.
With regard to nuclear countermeasures, this is one that is
not as mature in the sense of development of countermeasures
from a new standpoint as has the microbes because of the fact
this was fundamentally a cold war issue that was developed
through the Department of Defense and over the last several
years following the dissolution of the cold war threat, we have
had to revitalize the program. We are doing that in
collaboration with the Department of Defense.
We have a strategic plan for radiologic and nuclear
countermeasure development which will be available and was
signed off just last night and will be available to you. It
includes our intermediate as well as our long range goals. The
low hanging fruit is to expand the licensure for material that
is already in the strategic national stockpile as well as to
develop centers of excellence.
In addition, we are developing protectants as well as
response agents and importantly a program to use adult stem
cell reconstitution of bone marrow suppression following a
radiologic attack. We are using the expertise that was
developed in fighting cancer in which one gets exposed to
radiation deliberately to kill cancer cells, there is the
effect on the bone marrow which we are now using that expertise
to try and develop reconstitution.
The same can be said about chemical countermeasures. We
have a strategic plan that is not as mature as the radio-
biological one. This will likely be available at the end of
this calendar year and it is based on the same situation as I
mentioned in looking at what we already have in the strategic
stockpile and trying to expand the FDA-approved usage of that.
We are doing this in very strong partnership with the U.S.
Army Medical Research Institute of Chemical Defense. Again, we
have immediate, intermediate and long term goals. The long term
goal is to ultimately develop countermeasures that can be used
both to detect as well as to counter the effects of tissue
damage due to chemical weapons.
Finally, on this last poster, I want to mention the
coordination and the collaboration among the various agencies
to which the chairman alluded. At the NIH, we coordinate
through my institute by a Biodefense Research Coordinating
Committee. That is within the NIH institutes as a whole. Much,
if not all of the biological microbial is done through the
Infectious Disease Institute but when you get into chemical and
radiologic, we have a number of the other Institutes at the NIH
and we coordinate that through our committee.
The coordination within HHS as you will hear from Assistant
Secretary Stewart Simonson takes place in his office at the
Office of Public Health Emergency Preparedness and the more
global Federal Government coordination among agencies including
DHS, DHHS, DOD and others takes place through the Homeland
Security Council, particularly through the Weapons of Mass
Destruction Medical Countermeasures Subcommittee.
I am finished with the oral statement. I would be happy to
answer questions later.
[The prepared statement of Dr. Fauci follows:]
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Mr. Shays. Thank you.
We have four doctors and an honorable. Mr. Secretary.
STATEMENT OF STEWART SIMONSON
Mr. Simonson. Thank you.
Good afternoon. I am Stewart Simonson, Assistant Secretary
at HHS for Public Health Emergency Preparedness. I appreciate
the opportunity to share with you information on the
Department's progress on research development and acquisition
programs for medical countermeasures and specifically
implementation of the Project BioShield Act of 2004.
HHS shares the subcommittee's desire for an effective and
efficient interagency process to identify, prioritize and
acquire medical countermeasures to address chemical,
biological, radiological and nuclear threat agents. We also
share the subcommittee's concern that this process needs to be
linked to validated threats.
The events of September and October 2001 made it very clear
that terrorism is a serious threat to our Nation and to the
world. The Bush administration and Congress responded
forcefully to this threat by strengthening our medical and
public health capacities to protect our citizens from these
attacks. To encourage the development of new medical
countermeasures against threat agents and to speed their
delivery, President Bush in his 2003 State of the Union Address
proposed, and Congress enacted, Project BioShield. The $5.6
billion, 10 year, special reserve fund was created to assure
developers of medical countermeasures that funds would be
available for the Government to purchase critical products.
Since enactment, my office has moved aggressively to fill
immediate gaps in our countermeasures. A genuine sense of
urgency informs all of our homeland security work at HHS but it
is important to note that the successful development and
manufacture of safe and effective countermeasures requires an
investment of both money and time. No matter how hard we work
or how much money we spend, some steps in the process cannot be
rushed.
There is a complex spectrum of efforts needed along the
research and development pipeline to produce a usable medical
product countermeasure. Defining specifications for a needed
countermeasure often reveals few, if any, candidates in the
pipeline. To date, we have been fortunate that some of our
highest priority needs for medical countermeasures could be
addressed using the available, advanced development products in
the pipeline.
However, research and early development efforts, even when
robustly funded, often take years before a concept is mature
enough for advanced development. It is only when a product has
reached the advanced development stage that Project BioShield
provides a meaningful incentive for manufacturers the product
the rest of the way.
In determining the requirements for and elaborating options
on medical countermeasure acquisitions, the focal point for
U.S. Government interagency efforts is the Weapons of Mass
Destruction Countermeasures Subcommittee. HHS, along with
representatives from the Department of Homeland Security and
the Department of Defense, chair the WMD Subcommittee and
stakeholders from throughout the Government are represented on
its working groups.
In setting priorities for medical countermeasure
acquisitions under BioShield, the WMD Subcommittee considers a
number of factors. The credibility and immediacy of the threat
are driving factors and our informed by material threat
assessments conducted by DHS. We also consider the current and
projected availability of appropriate medical countermeasures
as well as the target population for which the countermeasure
would be used. In addition, logistical issues are considered
such as the feasibility of deployment in public health
emergencies, shelf life, storage and maintenance requirements.
Project BioShield also requires a number of findings by the
Secretaries of Homeland Security and HHS prior to an
acquisition commencing. These findings include three
determinations: first, that there is a material threat against
the U.S. population sufficient to affect national security;
second, that the medical countermeasures are necessary to
protect the public health from the material threat; and third,
that acquiring a specific quantity of a particular
countermeasure, using the special reserve fund, is appropriate.
These determinations are followed by a joint recommendation to
the White House by the two Secretaries. If approved, Congress
is notified and HHS executes the acquisition program.
The process that I have outlined has been successfully
implemented through contract award three times since the
enactment of Project BioShield less than a year ago. HHS has
completed contract awards for acquisitions of next generation
recombinant protective antigen anthrax vaccine, the current
generation licensed anthrax vaccine, and pediatric formulation
of potassium iodide. Additionally, the acquisition process is
in the final execution phases for several other needed medical
countermeasures including anthrax therapeutics, botulinum
antitoxin and next generation smallpox vaccine.
This robust interagency process mines the expertise in the
scientific and intelligence communities to define requirements
for medical countermeasures and enables policymakers to
identify and evaluate acquisition options to address immediate
and future needs.
In closing, let me say that HHS has a clear mandate from
President Bush and Congress to lead the charge in medical
countermeasure development. We have already made important
strides to address the public health needs of the Nation but
more needs to be done. I look forward to working with you and
the subcommittee to address the challenges of CBRM preparedness
and its importance to public health.
I look forward to answering your questions.
[The prepared statement of Mr. Simonson follows:]
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Mr. Marchant [presiding]. Thank you, Mr. Secretary.
The chairman had to attend a Rules Committee meeting and I
will be chairing for a while.
At this time, I will recognize Dr. Vitko.
STATEMENT OF JOHN VITKO, JR.
Dr. Vitko. Good afternoon. Thank you very much for inviting
me here to speak to you today on DHS's role in this process.
We at DHS do not develop medical countermeasures but play a
critical role in informing and guiding the prioritization of
those medical countermeasures. I would like to cover four key
steps in that process today: threat assessments and
determinations conducted specifically to guide Project
BioShield, a broader set of risk assessments, a strategy for
addressing engineered threats in partnership with and led by
the Department of Health and Human Services and scientific
studies to better inform these assessments.
As you know, the Project BioShield Act of 2004 charges the
Secretary of Homeland Security with the responsibility to
determine which biological, chemical, radiological or nuclear
threats constitute a material threat to our Nation's security.
To fulfill this responsibility, the Department of Homeland
Security Science and Technology Directorate, in partnership
with our Information Analysis and Infrastructure Protection
Directorate, has been conducting formal threat assessments on
the agents of greatest concern to establish plausible, high
consequence scenarios. These assessments are then used by the
Secretary of DHS in determining whether to issue material
threat determination and by HHS and the Interagency Weapons of
Mass Destruction Medical Countermeasures Subcommittee in
determining the need for and the requirements of any new
medical countermeasures.
To date, the Secretary of the Department of Homeland
Security has issued material threat determinations for four
agents: anthrax, smallpox, botulinum toxin and radiological
nuclear devices. Additional assessments are underway for
plague, tularemia, viral hemorrhagic fevers and chemical nerve
agents and will be completed this fiscal year.
DHS has an even broader responsibility in the President's
strategy for biodefense for the 21st century. In this strategy,
we are charged with conducting formal, periodic risk
assessments in coordination with other departments and agencies
to guide the prioritization of the Nation's ongoing biodefense
activities not just medical but also including such areas as
surveillance and detection, decontamination and restoration and
forensics.
These risk assessments factor in technical feasibility of a
broad range of biological threats. The vulnerability of
different portions of our society to those threats and the
resulting consequence of any such attacks. The first such
formal risk assessment is due in the winter of 2006 and will
address all Category A and B agents from the Centers of Disease
Control Prevention and Threat List, some Category C agents and
a number of potential engineered threats.
Recognizing that the rapid advances in biotechnology demand
that we also consider the possibility of engineered threats, we
have partnered with HHS and others in formulating and
implementing a strategy for anticipating and responding to such
threats. Together, we have developed an informed estimate of
the types of emerging threats that might be within the ability
of a terrorist organization to develop over the near, mid and
longer terms and have laid out a strategy for addressing them.
The strategy emphasizes ongoing technology watch and risk
assessments, rapid surveillance and detection capabilities for
engineered threats and expanded range of medical
countermeasures and an integrated concept of operations for
identifying and responding to emerging or engineered threats.
The threat or risk assessments described above are
performed with the best available information. However, there
are large uncertainties, sometimes factors of 10 to 100 in some
of the key parameters and hence in the associated risks. In one
case, it can be the minimum amount of agent needed to infect a
person and in another case, it can be the time that such an
agent remains viable, that is capable of causing an infection
in the air, food or water; and in a third, it can be the effect
of food processing or water treatment of the agent's viability.
The Department of Homeland Security has established a
National Biodefense Analysis and Countermeasure Center to
conduct laboratory experiments needed to close these knowledge
gaps. To support this and new facilities being designed and
constructed on the National Interagency Biodefense Campus at
Fort Detrick, MD. Pending completion of this facility in fiscal
year 2008, we have established an interim capability with other
Government and private laboratories to begin this vital work.
In summary, the Department of Homeland Security Science and
Technology Directorate, in coordination with its Federal
partners is conducting a threat and risk assessment critical to
prioritizing the Nation's near and long term medical
countermeasure development.
This concludes my prepared statement and I would be
delighted to answer questions at the appropriate time.
[The prepared statement of Dr. Vitko follows:]
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Mr. Marchant. Thank you, Dr. Vitko.
I would like to acknowledge that we have been joined at
this time by Representative Turner from Ohio, Representative
Higgins from New York, and Mr. Van Hollen from Maryland.
At this time, I will recognize Dr. Saldarini.
STATEMENT DR. RONALD J. SALDARINI
Dr. Saldarini. Good afternoon.
My name is Ronald Saldarini. I am currently a scientific
and business consultant to the vaccine and pharmaceutical
industry. From 1986 to 1999, I was president of the global
vaccine business of American Cyanamid and American Home
Products. I am here today as a member of the Committee on
Accelerating the Research, Development and Acquisition of
Medical Countermeasures Against Biological Warfare Agents which
was convened by the Institute of Medicine and the National
Research Council. In my remarks this afternoon, I would like to
draw attention to the committee's central findings and
recommendations.
First, let me note that the committee was convened in
response to a congressional mandate and was charged with
examining the DOD acquisition process for medical
countermeasures to protect against biological warfare agents.
We were asked to identify factors that were impeding the DOD
acquisition process and to recommend strategies for
accelerating the process. Our review was conducted throughout
2003.
The scope of the committee's assessment covered early
research and development through Food and Drug Administration
approval. We did not examine production and procurement
activities, the extent or nature of any biological warfare
threat or to assess the value to DOD of developing medical
countermeasures compared with pursuing other obligations. We
worked from the premise that biological weapons pose a threat
to the health of military personnel and that additional FDA
approved countermeasures are needed.
Under the best of circumstances, developing new vaccines
and drugs is technically and financially challenging.
Furthermore, developing biodefense products poses additional
scientific, regulatory and ethical challenges because it is not
always possible to test efficiency in humans. In our review of
DOD's work on medical countermeasures, we have found
fragmentation of responsibility and authority, changing
strategies that had resulted in lost time and expertise, and a
lack of financial commitment adequate to meet the requirements
of the program's goals.
The work was part of a program covering both medical and
non-medical countermeasures against both chemical and
biological warfare threats. Responsibility for centralized
oversight of the program, for program planning and budgeting
and for operational tasks was distributed across several
different chains of command.
We viewed the state of the program as an indication that
DOD leaders lacked an adequate grasp of the commitment, time,
scientific expertise, organizational structure and financial
resources required for success in developing vaccines and
drugs. We also saw it as an indication that DOD had not given
the task sufficient priority to produce the desired result.
In response, we recommended action in several areas. We
first recommended making the DOD program a truly high priority
which would include organizational, scientifically
knowledgeable leadership, scientific infrastructure improvement
and necessary funding to achieve program goals. We recommended
accomplishing these changes through the creation in DOD of the
Medical Biodefense Agency which would be a new agency with
comprehensive responsibility for the research and development
program for medical countermeasures against biological warfare
agents.
We proposed that this agency consolidate the functions and
resources of several existing activities to overcome the
competing lines of authority and multiple reporting
relationships that the committee had found. In the committee's
view, it was essential that the head of this agency have direct
authority over budgeting and over the full range of agencies
management and operational activities including managing
candidate products from the science and technology stage into
and through the DOD acquisition system.
The committee also recommended giving the Medical
Biodefense Agency responsibility for developing medical
countermeasures against infectious diseases. We emphasized the
agency should have a highly qualified director with strong
experience in vaccine and drug research, development and
manufacturing. In addition to strengthening the intramural
research and development program, the committee encouraged
building a strong extramural program to bring the expertise and
creativity of industry and the academic community to the task.
External oversight and accountability for performance were
also seen as necessary. The committee recommended an annual,
independent, external review by a standing group of experts
from academia and the biotechnology and pharmaceutical
industries. If DOD were not taking the steps necessary to
establish an effective program and make appropriate progress,
some or all of the responsibility should as a last resort be
transferred from DOD to another appropriate Federal agency.
Finally, the committee also pointed out the need for DOD to
work with other Federal agencies and the broader scientific
community to address other challenges which would include
establishing effective collaborations with academia and
industry and reducing administrative and legal barriers to such
collaborations, meeting the special regulatory challenges in
testing biodefense projects, overcoming current and potential
bottlenecks from insufficient access to essential research
resources, including specialized laboratory facilities,
laboratory animals and ensuring the availability of a well
trained work force.
For many years, DOD researchers were among the very few
pursuing the development of medical countermeasures against
biowarfare agents. Despite the recent upsurge in interest,
effort and funding aimed at protecting the civilian population
against bioterrorism, the committee saw a need for a continuing
and effective DOD program to ensure that unique military needs
for battlefield protection receives sufficient attention.
Thanks for the opportunity to testify and I am pleased to
answer any questions you have.
[The prepared statement of Dr. Saldarini follows:]
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Mr. Marchant. Thank you, Doctor.
Mr. Platts is with us at this point and we will now begin
questions. Mr. Turner and Mr. Platts, do you seek recognition
for questions? The Chair recognizes Mr. Turner.
Mr. Turner. Thank you, Mr. Chairman.
I want to thank Chairman Shays for holding this hearing and
continuing his efforts in ensuring that our country is prepared
in the area of the terrorist threats that we are facing both in
the area of first responders and in the areas of our Federal
agencies that have responsibilities for coordinating their
efforts as we plan and also restructure our assets to address
these threats.
Dr. Klein, in looking at your testimony and in light of the
chairman's efforts for us to get an understanding of past and
current approaches, how we are being flexible in transforming
to meet the risk, at the top of page 3 I see your comparison of
the past and current approaches and I get a little confused.
The first sentence says, ``The current CBRN defense strategy,
the current strategy, emphasizes a capabilities-based approach
rather than the previous approach which provided greater
emphasis on prioritizing threat agents and targeting budgetary
resources based on validated intelligence.'' When you talk
about the previous approach, you say the previous approach had
a greater emphasis on prioritizing threat agents and targeting
budgetary resources based on validated intelligence. If we are
going away from that, it sounds to me like we are preparing for
things that we know aren't likely to happen and diluting
resources from things we know may happen but I am certain that
is not what you mean.
Going to the next one, it says ``Capabilities-based
planning focuses more on how adversaries may challenge us than
on whom these adversaries might be.'' You go on to emphasize
the reduction of the dependence on intelligence data. Could you
give us your thoughts separate from the testimony that is
written here on what that contrast means?
Dr. Klein. That is certainly a very good question. If you
look at the way the Department of Defense is trying to
transform, we are trying to go through a capabilities based
approach as opposed to the specific threats. If you look at
what we had done in the past, we looked at specific things like
anthrax, botulism, what is happening in today's environment is
we are now seeing a lot of engineered threats, genetic
activities and things which we cannot pursue, for example,
vaccines against everything the terrorists might throw at us.
What we are trying to look at is a more broadbased generic
approach so rather than saying, for example, that country x is
developing a specific toxin be it chemical or biological, we
are trying to have a more broadbased approach so that we are
not having to rely specifically on intelligence. Hopefully we
will be able to respond in a more quick and broad way.
Certainly the issues facing our Nation, where civilians are
being targeted as well, with our advances in genetic
engineering, it is very difficult for us to come up with
specific antidotes, pills, vaccines for everything the
terrorists might throw at us. So therefore, we are going to a
more broadbased approach.
We still need actionable intelligence on how to perform but
we are trying to do more on capabilities rather than a specific
threat.
Mr. Marchant. Mr. Platts, do you seek recognition?
Mr. Platts. I apologize for my late arrival and do
appreciate the written testimonies. There are a couple
questions I would like to address.
Dr. Klein, I think in your testimony you talked about the
Joint Vaccine Acquisition Program. I am just trying to get an
understanding of the $322 million committed in 1997 and where
we are today. Am I understanding correctly that we are talking
about fiscal years 2012, 2020 is when we expect to see results
from this investment we are making?
Dr. Klein. We hope we will see investments earlier. As you
probably realize, getting a vaccine licensed is challenging at
best. It takes a long time. Certainly HHS and DHS as well as
Dr. Fauci have realized we have these challenges.
We are doing now with the animal efficacy rule will let us
speed up processes. DOD only uses licensed vaccines, so we have
a requirement to go through a long and cumbersome process, but
we certainly hope we will have these vaccines available prior
to 2020. What I think is really changing our ability to license
vaccines will be the animal rule and our understanding of
genetic characteristics such as a better understanding of the
DNA.
Mr. Platts. From a funding standpoint, what are the current
projections on the cost, the $322 million we have already
invested?
Dr. Klein. That is correct. During the building of our 5
year budget from 2006 to 2011, we added an additional $2
billion for our chemical-biological defense program. Probably
$80 million of that will be directed toward vaccine development
so that we can protect our men and women in uniform. Our
mission is somewhat easier than the civilian side where they
have a very large age group to be under consideration from
infants to the elderly. In our case, we have men and women of
very healthy, predictable ages. So we are optimistic that some
of our applications will come out earlier than those that will
be more broadbased for the entire population but we are
investing a considerable amount of money for vaccine
development.
Mr. Platts. The $322 million investment is not a lost
investment, that is laying a foundation?
Dr. Klein. Yes, it is laying a foundation. It is absolutely
not a lost investment. We had clinical trials, we had product
development. So it was not money wasted by any means.
Mr. Platts. I chair the Subcommittee on Financial
Accountability so I am always looking at what we are investing,
how we are investing and bottom line, what return are the
taxpayers getting, so I understand this is a very complex
process and it is multiyear, but I want to make sure that we
are moving in the right direction.
Dr. Fauci, on the actual investments or the research being
done, how are we not competing with the private sector for the
free market reasons for pursuing these projects with tax
dollars? How are we guarding against that?
Dr. Fauci. Actually, we don't want to compete, we want to
totally synergize with them. We cannot make countermeasures
ourselves. We are not manufacturers of countermeasures. We do
the basic research and the clinical and applied research and
partner with either biotech or pharmaceutical companies to
ultimately develop a countermeasure.
In fact, that is the whole purpose of the BioShield Project
where the HHS in the form of NIH predominantly does the
research that does the concept development, does the early
Phase I, II and sometimes into more advanced development and
then the companies partner with us to actually manufacture it
and make the commitment which under the circumstances that we
have now are being aided by the set aside money, the $5.6
billion in BioShield, to be able to then make a procurement of
that. It really is a partnership. It is not at all a
competition.
Mr. Platts. Thank you.
Mr. Marchant. Dr. Klein, in your testimony, you talk about
the DOD Clinical and Biological Defense Program activities and
state they are informally coordinated with the Department of
Health and Human Services. Can you talk to us about the
informal agreement and how it works?
Dr. Klein. One of the things we do is we have a lot of
interaction at the working level where the staff of the
Department of Defense meets with Stewart Simonson's staff. We
have a lot of technical exchanges, a lot of regular meetings
scheduled and in addition, Mr. Simonson and I meet periodically
to prioritize to make sure we are spending the taxpayers'
dollars in the most effective way, that we are not duplicating.
The current agreement we are trying to work between the two
departments is where DOD's role and responsibility will be
clearly defined on some of the screening and up to Phase 1,
then we will transfer that work through the Department of HHS
where they can take it through more of the clinical trials
where they have greater expertise than DOD. So we are trying to
utilize the expertise of both departments to the benefit of the
taxpayer.
Mr. Marchant. What steps has DOD taken to respond to the
Institute of Medicine?
Dr. Klein. We have taken several steps. I was confirmed in
2001 about the time a lot of activities were increasing,
obviously the terrorist attack and subsequently the anthrax
attacks. We have reorganized the Chemical and Biological
Defense Program to have a Joint Requirements Office through the
joint staff where they define our requirements; we have
organized our science and technology development through the
Defense Threat Reduction Agency; we have increased the
technical competency of our staff where we have several
professional medical staffs onboard; the Deputy for the
Chemical and Biological Defense Program is a medical doctor, a
former Assistant Surgeon General of the Air Force. We have
taken a lot of the recommendations of the Institute of
Medicine.
Since then BioShield has been created in addition to the
Department of Homeland Security. So there is a lot of
activities created since the Institute of Medicine study.
Mr. Marchant. Can you explain why the JVAP program should
continue to receive funding in its present form?
Dr. Klein. The JVAP Program is one which like all programs,
it has successes, it has things we would like to occur at a
more rapid rate but the program is responsible for the vaccine
procurement as well as a lot of the science and technological
development. Again we are focusing a lot of attention on that
program. The Army is the executive agent for this activity. We
have a joint program activity through the Army to coordinate
those activities. So we are focusing our attention to hopefully
increase the end result and that is to protect our men and
women in uniform.
Mr. Marchant. Secretary Simonson, you say in your testimony
that HHS has defined a three stage development and acquisition
strategy with open competition awards at each stage. How are
you reaching out to companies who have developed or are in the
process of developing countermeasures?
Mr. Simonson. That is an important part of the operation of
BioShield and our success I think will be contingent upon how
well we are out there probing the market to bring firms in to
propose on our various projects. One we do it is with request
for information where we will actually send out a circular
seeking sources to find out what is out there, what companies
are making product or investing in products that might be
useful to us. It is a way of doing market research and also
assessing the state of science.
We are also working very aggressively through the WMD
Subcommittee to understand what is going on in other agencies.
Dr. Klein mentioned the informal work that he and I are doing
to bring our two agencies together. There is also a more formal
process, this Weapons of Mass Destruction Subcommittee where
you have all of the stakeholders in the Federal research
community. That is a place where we can exchange information on
who is funding what and try to elicit support for or interest
in the projects we are trying to develop.
I think those are two ways that we do it. We are also still
learning. There are other ways of reaching out to industry,
especially the smaller, biotech companies to keep them
interested in BioShield.
Mr. Marchant. Do you feel there is sufficient interest out
in the biotech industry to try to address these issues? Do you
think there is sufficient interest in that industry to
stimulate the kind of research we probably need?
Mr. Simonson. I think there is sufficient interest. I think
the interest is more in the smaller biotech firms than it is in
big pharma simply because of the tradeoffs that have to be
made. Dr. Fauci talks about the relative tradeoff of
cholesterol lowering agent as opposed to a biomedical
countermeasure. There is no comparison. The whole vaccine
market worldwide is less than one cholesterol lowering agent,
so it is not as appealing to the big manufacturers so I think
our future is with the small to medium sized biotech firms.
There is a lot of work to bring this along but once you do,
you are building an infrastructure, building something within
the United States that can be useful to us in other ways. It is
a very labor intensive and collaborative process between us and
these biotechs. The ultimate result is one that makes the
industrial base better in the United States, we think. We saw
this with the company that produced the second generation
smallpox vaccine.
Mr. Marchant. Dr. Saldarini, your committee concluded
biodefense efforts of DOD were poorly organized to develop and
license vaccines, therapeutic drugs, and antitoxins to protect
members of the armed forces against biological warfare agents.
What can we expect from the JVAP Program it continues in its
current form without implementing your committee's
recommendations?
Dr. Saldarini. First, while JVAP was the topic of
conversation during the committee's deliberation, and while it
was clear there were some issues with JVAP in terms of their
activities for acquisition, it was the committee's conclusion
that JVAP was not the sole source of the problem, in fact was a
part of a larger problem where it was unclear who was in charge
of the program and assessing priorities and how the entire
thing was organized to get something done.
If you look at the charts that we looked at as we tried to
evaluate the different groups involved, it became very, very
difficult to understand the distinction between each of these
groups. It was an alphabet soup of acronyms for an outsider who
doesn't live in the military or the DOD on a daily basis. It
was very difficult to assess who was in charge of what and how
things actually got done and how priorities were moved through
the systems.
So where JVAP did have some problems, JVAP was not the sole
source of the problem. From our perspective, it was the overall
organization with an inadequate priority infrastructure funding
resource base that created the problem.
This committee finished its activities in 2003, so it has
been 18 months since we last, or certainly I looked at it and I
don't believe any other of the former committee members have
looked at it, so I don't know really what has transpired. There
were changes. Apparently Dr. Klein mentioned something about
changes with JVAP but I don't know what they are and I don't
think any of our committee members do.
We reported what we found at the time. Perhaps things have
been streamlined but it is still unclear to me whether or not
there is adequate authority available to make things happen in
a committee fashion.
Mr. Marchant. Thank you.
The committee counsel would like to ask some questions.
Mr. Halloran. First, Dr. Fauci, NIAID awarded a grant to
the Dynport Vaccine Co. which is the prime integrator or
contractor for the Joint Vaccine Acquisition Program. Could you
tell us something about that grant and why it looked on the
face to be a duplication of paying for an activity that JVAP is
already being paid for.
Dr. Fauci. It may appear that way but it actually is
complementary. The grant that we are talking about was actually
three grants and a contract to Dynport and the total was I
think about $29 million. Two grants were to support development
of a vaccine candidate for botulism toxin that complemented the
activity that was going on in the Department of Defense.
In addition, there was a grant for Phase II trial of the
Venezuelan Equine Encephalitis. Again, although the DOD was
also working on that, it was complementary and one was to
support research on a vaccine candidate for tularemia which the
DOD had responsibility for before but then handed that over to
us and we are now working fundamentally on the tularemia.
So if you look at the organisms and match them, you say,
wait a minute, the DOD is really doing that but actually in one
of them, they are no longer doing the tularemia and the other
two are complementary working on aspects of it that the DOD is
not.
Mr. Halloran. Complementary in the sense of adding the
population to the testing profile that Dr. Klein mentioned that
the DOD doesn't have to cover?
Dr. Fauci. There are two things, different scientific
aspects but importantly geared toward and Dr. Klein mentioned
this in his oral testimony, that they are fundamentally looking
at forced protection and the warfighting individuals where we
are looking at everything from children up through and
including the elderly. It is much more for the civilian
population, so a lot of the complementariness is due to the
broader scope of people that we are responsible for in the
civilian population.
Dr. Klein. I think this is an example of the two
departments working together very well where we complement to
the benefit of the taxpayer rather than duplicate. When you
look at just the headlines and don't dig into the technical
aspects of it, one can see on paper it might have been
duplication until you really look at the details.
Mr. Halloran. Why did DOD hand over the tularemia work? Is
that not a force protection threat?
Dr. Klein. We felt that NIAID had better technical
expertise than the Department of Defense. We took it up to a
certain point and felt their technical expertise was better
than ours.
Mr. Halloran. Let us talk about botulism, where we are. The
next panel has some testimony about some kind of halting and
stumbling attempts to get botulism antitoxin, particularly
outside the A and B serotypes. Where are we in that, both in
terms of what we have in hand should an attack take place in
the United States now or in the military theater and what is
coming down the pipeline and when?
Dr. Fauci. Botulism is a complex issue and is somewhat
problematic for a number of reasons that I will briefly
describe. There are seven, it is a heptavalent toxin and we are
in the process now of making monoclonal antibodies which are
antibodies against a particular component of a botulism toxin.
The most common that are used are A, B and E but you really
have to have sort of a cocktail of all of them.
The difficulty that we face with transitioning from the
horse sera botulism antitoxin which has been the standard that
has been used both in the unusual occurrence of situations of
natural infection with botulism in this country as well as what
the DOD has been working on for years as a countermeasure for
force protection. The transition from the polyclonal sera and
plasma from the horses is taking a lot of time for the simple
reason that relates to one of the things we have been saying in
one way or another among all of us, the difficulty in engaging
researchers and industry on the outside to get involved.
We have one very good researcher that is superb at
developing the initial monoclonal antibodies against the
individual subtypes of botulism. The difficulty is that this is
one group working alone so it takes about 6 months per subtype
and then you hand it over to the more industrial related ones
that go on do the actual manufacture and the clinical trial.
So if you stagger them at 6 month periods, by the time we
get a robust heptavalent polyclonal cocktail, it is going to
take several years. It would be wonderful if we had 20 or 30
investigators on it but there just is not the interest that we
would like to see for the reasons that people want to work on
other things. That gets back to the principle of trying to
incentivize not only individual investigators but also
companies to get involved.
Right now in an emergency we would have to rely on the
polyclonal serum that we have had and are making more of but
hopefully we will transition over to the monoclonal antibodies.
Dr. Klein. One of the areas and what I am hoping is as we
get a better understanding of our DNA structure, that the kinds
of research activities that individuals are currently
performing will be enhanced by genetic splicing, DNA splicing
and things of that nature. So we are hopeful that we will be
able to get products out quicker with our understanding of the
basic fundamental responses under our DNA.
Dr. Saldarini. I can talk about the current generation
botulinum program. HHS picked up after September 11th a DOD
program that began during the first Gulf war to hyperbenize
horses against all seven serotypes and then to ferrice them and
collect this hyperimmune plasma but it was never finished. They
just had fairly substantial amount of hyperimmune plasma in
storage. It was transferred to us I think at the end of 2002.
HHS undertook to have that material processed. This was a
process that hasn't been done in an awful long time, so the
firm we engaged to do it had to spend a lot of time moving
deliberately because of the risk of losing material if they
made a mistake. In any event, that work is done. They finished
processing the plasma. We had sort of mixed results on the
yield because of the age of the plasma and so forth. I would be
happy to come to your office give you more detail on exactly
how much we have. We don't talk about it openly.
We also have a program now where a whole new population of
horses is being hyperimmunized against all seven serotypes.
This is an example of where things can't be rushed beyond what
science will allow. The horses have been immunized and then
challenged with botulinum but it takes a period of time to get
the titer up so you can actually begin to ferrice them.
We expect some time in the fall that we will have enough
hyperimmune plasma that we can begin processing the new
material. We have an objective, an ultimate objective of
100,000 treatment courses of heptavalent antitoxin but it is a
big operation, 200 horses over a few farms and it is also I
have learned as much an art as it is a science.
The current botulinum toxoid or vaccine is no longer
licensed, it is in IND status and there is a cohort within the
research community and at the Defense Department that has a
need for botulinum vaccine and so we are looking at what
options are available there.
Dr. Vitko. It is an interesting term because I use
capabilities with a slightly different meaning. Right now I
believe that it still makes a lot of sense to look agent by
agent in terms of the extent of the threat that they pose. So
we look at the feasibility of a terrorist organization
engineering that threat, producing that agent, disseminating it
and look at the consequences associated with it and we do make
use of intelligence information both on interest by known
organizations, skills levels associated with those
organizations to give some assessment of what could be done,
but then we really do take a look at the scientific basis for
producing that agent and disseminating it, irrespective of the
threat group. We believe at this stage that is the best way of
assessing what constitutes a material threat to this country.
Material threat determination says if an organization can
produce it, is it one. As you heard, we postulated and
formulated working with HHS in an interagency forum a timeline
for when we think certain engineered threats could come on and
the general characteristics of those. We have developed a
strategy for dealing with that as well as a hedge strategy in
case our projections are off.
I think in that sense it will be a while until we get to
the goal where we can treat broad classes of agents as a class
and until we have, as desirable as it is, sort of broadbased
either vaccines or antibiotics for dealing with those. That
doesn't take away from that being a desirable R&D goal but for
near term strategy, I think it does have to focus on which
agents pose the greatest risk in the current scenarios.
Mr. Halloran. Thank you.
Mr. Marchant. The Chair acknowledges that Mr. Duncan from
Tennessee has joined us. Mr. Duncan, do you have any questions?
Mr. Duncan. Thank you and since I just got here, I won't
ask any questions but I will say this. I am disturbed about
this statement or Chairman Shays' that says ``A 2004 study by
the Institute of Medicine found that the Department of Defense
Biodefense Program fragmented and often prey to competing
priorities. Launched in 1997 with $322 million, the JVAP has
spent that much and more. Yet lists of JVAP accomplishments
provided to the subcommittee included just one recently
licensed therapeutic, no completed vaccines and two target
vaccine programs terminated after significant expenditures.''
I notice there is testimony from one of the witnesses on
the next panel that says ``This procurement process which
formally began on April 1, 2004 and has yet to be completed 14
months later is simply too long and too burdensome to sustain
continued interest in participating in BioShield by companies
such as Human Genome Sciences whose principal focus is not the
Federal sector.''
I serve on three different committees and several different
subcommittees and I read articles and columns all the time
about what all these other committees and subcommittees do. It
seems that every day we see examples of unbelievable waste and
inefficiency here at the Federal level. It seems if we want
something to cost 10 or 15 times more than it should and 10 or
15 times more than it would with fewer results than if the
private sector did it or if State and local governments did it,
just turn it over to the Federal Government. It gets pretty
tiresome to hear this out of every department and agency.
Everybody today, because we have a patriotic fervor going
on wants to give the Department of Defense everything they ask
for and more but the waste and inefficiency, we had a hearing
in this committee last week which said the Department of
Defense has blown $466 million in its ordinary procurement
processes. We just gloss over things like that because I guess
figures in the billions and $466 million are too big to
comprehend but it gets pretty sad after a while.
Thank you, Mr. Chairman.
Mr. Marchant. Thank you, Mr. Duncan.
I thank the panel today for its participation and we will
recognize the next panel. Our next panel will be: Dr. Michael
G. Hanna, Jr., Chief Scientific Officer, Intracel and Dr. James
H. Davis, executive vice president and general counsel, Human
Genome Sciences, Inc.
[Witnesses sworn.]
Mr. Marchant. At this time, the Chair will recognize Dr.
Hanna for his testimony.
STATEMENTS OF DR. MICHAEL G. HANNA, JR., CHIEF SCIENTIFIC
OFFICER, INTRACEL; AND DR. JAMES H. DAVIS, EXECUTIVE VICE
PRESIDENT AND GENERAL COUNSEL, HUMAN GENOME SCIENCES, INC.
STATEMENT OF DR. MICHAEL G. HANNA, JR.
Dr. Hanna. First of all, let me say how grateful I am for
having the opportunity to address this congressional committee.
As you, I am also concerned that such a committee meeting on
the Elusive Antidotes of CBRN Countermeasures must be held in
June 2005.
I would like to tell you about a successful development of
a unique therapy for botulinum toxin exposure. This story
consists of scientific success and extreme frustration. There
are seven serotypes of botulinum toxin. They have been
identified as the most dangerous biological substances and the
most likely biological weapons of mass destruction.
The success is that my company, Intracel, through a
Department of Defense contract, referred to earlier by one of
you, between 1991 and 1996 was successfully able to develop a
heptavalent equine antibody product that was efficacious in
combating the seven serotypes of botulinum toxin, was safe in
humans and was FDA-approved for emergency use. We made 5,000
therapeutic doses before the project was terminated by the
Joint Program Office of the Department of Defense in 1996. It
was terminated at this point because we had proof of principle
and a botulinum crisis was improbable. Since September 11th,
however, the improbable became probable.
Today, Federal officials fear the world is vulnerable to
such an attack and we are ill prepared if one were to occur. In
fact, Tommy Thompson in his exit speech to HHS declared that he
was surprised that such an attack had not already occurred,
which also surprised me that he would say that. Dr. Anthony
Fauci of NIAID was quoted that this is one of the Federal
Government's top bioterrorism interests and ``we are marshaling
all available resources.'' This statement was made in 2002; yet
as far as I know, as of last year, we still had only the
residual several thousand therapeutic doses left over from
Intracel's previous effort. Today there was some discussion
where they were not prepared to discuss what they have today
generated from the new contract and I can tell you they have
monoclonal product only not heptavalent product.
I was at a meeting with the Department of Defense, the
Army, when one of them mentioned that they had monoclonals to A
and B and Congressman Dr. Roscoe Bartlett said, let us not let
the terrorists know that because then all they have to worry
about is C through G.
This is my frustration. With our scientific success of
overcoming the hurdles to produce such an important therapeutic
product, we have not been successful in fulfilling our destiny
of producing the hundreds of thousands of doses necessary to
protect our military and civilian populations at risk. In Los
Angeles, they had a simulated botulism attack which was very
successfully carried out. They calculated they would have
needed 600,000 doses to protect the population at risk. This
was months ago. We are no where close to having that number of
therapeutic doses.
The NIH used considerable resources to fund grants to make
recombinant vaccines for protection of botulinum infection and
to develop drugs which would interfere with the enzymatic
activity of the organism. These efforts however worthwhile are
problematic 10 year endeavors.
Today, Intracel holds the intellectual property, over 300
standard operating procedures and all the necessary equipment
to produce the proven heptavalent equine therapeutic product
and was willing and capable of generating through private funds
to develop a subsidiary that would build a validated
manufacturing facility and produce 50,000 therapeutic doses in
2 years. The yield would be more than 100,000 doses per year
thereafter. We made this proposal in 2002.
In addition, using our own moneys, Intracel offered to
complete the research program and begin the next generation
product using safer and more effective human monoclonal
antibodies. We happen to be the only company that has ever made
a licensed human monoclonal antibody. This second generation
product could be prophylactically used and be safe for multiple
injections for better protection of the troops after an
exposure.
Clearly, we thought we were the poster child of BioShield.
However, in spite of who we contacted and how hard we tried, we
could not get the Government to give us a written commitment to
purchase the product based on our success in meeting the
specifications that we had established for the DOD in 1997. We
talked to everybody and anybody and we had Congressman Shays
and Congressman Bartlett with us at many of the meetings.
It seems that the Government agencies are not really
marshaling efforts to deal with this problem. The agencies have
relegated down to the ranks of the functionaries and contract
and grants sections and if they have the urgency that this
issue requires, it has not overcome the status quo.
I would like to know what we would have done last year,
this year or next year if such a botulinum toxic weapon was
used in the United States in the real sense, not in a simulated
sense as we did in Los Angeles a few months ago. Clearly the
BioShield concept with all of its good intentions has not
gained the strength to overcome the status quo.
I would like to repeat, Intracel was not asking the
Government to pay for the production of this important
component of our medical armament for biodefense. Intracel was
asking the Government to give us a commitment to buy the
product if we met specifications already paid for by the
Department of Defense. That probably was our mistake in not
asking for money.
To rapidly generate required antidotes and therapies for
weapons of mass destruction requires a paradigm of built-in
redundancies such as those employed in successful NASA goals
and accomplishments after the Presidential mandate by President
Kennedy. I would have thought that BioShield provided the
capability to build in redundancies but it appears to me from
people I have talked to, BioShield does not impart this kind of
legislation.
Thus, I recommend to this subcommittee that the BioShield
legislation should be rewritten so that it funds multiple
groups and creates competition of several companies up to Phase
1 trials, then let the survivor of the most competent prevail.
With that type of competitions, you would have redundancies to
better guarantee success and you can end up with the stockpiles
that will save lives if such an emergency occurs. No longer
should we rely on these products being generated by the low
bidders as an independent agent for any agency.
Second, I think what we saw this morning is that the
stovepipe type of funding coming down through the agencies does
not really bode well for interagency interactions which we are
going to need both at the development level, the manufacturing
level and mostly at the level of preparedness and defense out
in the field, the States and the counties and the cities if
such an attack ever occurs.
Thank you.
[The prepared statement of Dr. Hanna follows:]
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Mr. Marchant. Thank you, Dr. Hanna.
Dr. Davis.
STATEMENT OF JAMES H. DAVIS
Dr. Davis. Mr. Chairman, members of the subcommittee, thank
you for the invitation to appear before you today on behalf of
Human Genome Sciences.
I am Jim Davis, executive vice president and general
counsel of HGS. In this capacity I have been extensively
involved with the business development, regulatory approval
process and Federal procurement issues related to the
anticipated sale of our innovative, therapeutic treatment
Abthrax for victims of anthrax exposure. We undertook this
project on our own initiative and at our own expense.
HGS is a biopharmaceutical company located in nearby
Rockville, MD that discovers, develops and manufactures
innovative drugs to treat and cure disease. Currently, we have
seven drugs including Abthrax in clinical development,
including six monoclonal antibodies.
The primary focus of our company, however, is not the
development of drugs to protect against attack by biological
and chemical weapons. The principal focus of our company has
been and will continue to be pursuit of innovative
biopharmaceutical products for the commercial market.
Nevertheless, just over 3 years ago we realized that our
company had significant technology and capability to develop an
effective, near term countermeasure against one of the Nation's
most immediate and serious bioterrorism threats.
Located just outside Washington, DC, we witnessed firsthand
the potentially devastating effects of the use of anthrax as a
terrorist weapon in late 2001. Using our own funds, we
developed a fully human monoclonal antibody drug called Abthrax
that can prevent and treat the lethal effects of anthrax
infection. The drug can be given prior to or after exposure,
can be used alone or in conjunction with the current vaccine
and antibiotics.
We have shown in animals that it is effective against high
doses of anthrax, we have demonstrated initial safety in humans
and we have been ready to manufacture this product and complete
the final human safety trials for over a year and a half, but
to move forward we need to bring to conclusion the lengthy
procurement process now underway with the Federal Government.
If a contract is signed with the Federal Government and a
final commitment to acquire a fixed number of doses and the
number of doses requested is of sufficient commercial quantity
to make it worthwhile, this countermeasure could be available
for emergency use as early as next year. While this is an
exciting prospect for our company and of valuable benefit to
the Nation, our frustration remains the Federal Government
could have had this product in the stockpile already if the
full authority of Project BioShield had been used as intended.
The primary challenge of biopharmaceutical companies such
as HGS in this field is the absence of a commercial market for
bioterrorism countermeasures. The only valuable market is the
Federal Government and perhaps our foreign allies. Without a
clear and easily accessible market, the drug will not be
developed.
In its initial BioShield solicitation for anthrax
therapies, HHS has not even specified the precise amount of
quantity they wish to purchase. Rather, the solicitation
requires bidders to pose pricing for a broad range of
quantities ranging from 10,000 doses to 200,000 doses. It now
appears that even if this contract is awarded and HHS decides
to exercise its option for the manufacture, HHS is unlikely to
purchase a full 200,000 doses as originally proposed.
This is particularly frustrating since the manufacture of
these compounds requires significant manufacturing capability
and significant manufacturing startup costs. In short, the cost
per dose of 200,000 doses is significantly less than the cost
of 100,000 doses and astronomically less than the amount for
10,000 doses.
Setting a firm commitment for the quantity to be purchased
and making sure those quantities are large enough to be
commercially viable is critical to advance BioShield's purpose
of promoting the development of a biodefense industry.
My written testimony raises additional concerns. There are
several steps HHS could undertake to increase industry
participation. In the interest of time, I will not enumerate
them here. Let me say, however, that timing is critical. I
applaud the subcommittee for its continued oversight of this
critical biodefense program. Near term delays in evaluating and
considering the production of viable countermeasures can
disproportionately prolong the procurement of such drugs. To
date, abthrax has been developed entirely with private funds
but to move forward, we need a firm commitment from the
Government to purchase this product. With sufficient Government
support, HGS could begin producing significant quantities of
Abthrax by the end of next year.
We look forward to formalizing this commitment in a
contract with HHS in the coming weeks and we would appreciate
every effort to ensure that maximum quantities are purchased
for the stockpile as soon as possible without any further
delay.
Thank you for this opportunity to testify and I look
forward to answering your questions.
[The prepared statement of Dr. Davis follows:]
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Mr. Marchant. Thank you, Dr. Davis.
The Chair recognizes Chairman Shays.
Mr. Shays. Gentlemen, thank you for being here today. I
feel badly that I could not ask some questions of the previous
panel because I wanted to get into the stovepiping and so on. I
wanted to get into why DOD has one program and others have
another and I wanted to get into the connection between them.
What did you hear from the previous panel that you agreed
with the most and that you would disagree with the most? I
would ask that of each of you. Dr. Hanna.
Dr. Hanna. I agreed with the statement made by HHS
representatives that working with large pharmaceutical
companies is not really going to work. They really could make
much more money with a cardiovascular drug than they can with
these types of vaccines. There are many vaccines that were made
that were never used because they couldn't make any money
selling them. The countries that were going to use them
couldn't afford to pay for them.
Working with the smaller, mid-size, biotechnology companies
is probably clearly the way to go. Unfortunately, even those
companies are not going to do some of this work on contracts or
grants because they can't make a living at a 6 percent margin
on the work they do but this is the way the legislation is
written to allow them to fund their programs.
I think the legislation needs to be changed to allow for
multiple awards, grants or contracts or allow companies to come
in and do it on their own but still let them compete. This is
the way good science gets done in the major projects this
country has launched.
Mr. Shays. What statement did you disagree with the most by
any of the previous panelists?
Dr. Hanna. I disagreed with the fact that the vaccines in
the JVAP Program and in some of the other programs are
difficult to accomplish. We could have had an anthrax vaccine a
couple of years ago, we could have had a couple hundred
thousand botulinum antitoxin, polyclonal equine botulinum
antitoxin in our repertoire. The urgency is there at the top
level at the present and it is at the congressional level and
the Senate level and at the top offices of these departments
but when it filters down to the functionaries, the urgency is
lost and the status quo steps in and this is demotivating to
the small, medium or large pharmaceutical companies.
Mr. Shays. Explain to me why we don't have progress in
those two areas? Tell me specifically why. You are saying it is
motivate up here but what specifically wasn't done that should
have been done?
Dr. Hanna. It is my understanding that the legislation
doesn't allow them to think outside the envelope, that they
have to function according to the legislation and the
legislation allows them to award a contract to the lowest
bidder and that contract is what they live with. If they would
allow them to award several contracts simultaneously for the
same project and let them compete to Phase 1 trials and the one
that gets to the Phase 1 trials and can work with the FDA the
fastest ends up with the purchase order is the way to go.
Mr. Shays. You are saying that you would cover the research
costs for the three or four that would get involved?
Dr. Hanna. We offered to do it through private investment.
We had investors.
Mr. Shays. You were willing to compete privately in a
contest because you believe you would have had a better product
in the end?
Dr. Hanna. We have already made it, we had already made it.
We spent $25 million of DOD's money to make the first 5,000.
Mr. Shays. I know that and that is why I am asking you why
we don't have it? What in the law prevented them from moving
forward with you?
Dr. Hanna. I don't know. I spoke to somebody recently who
is well known in this area and he said the law just prohibits a
multiple contract or multiple awards for the same project.
Mr. Shays. Why would they have had to do multiple awards?
If you already had it, why couldn't they just contract to you?
Dr. Hanna. They did. They contracted a foreign company. HHS
contracted a foreign company to make it.
Mr. Shays. Because you were a higher bidder? You weren't
the lower bidder?
Dr. Hanna. We didn't bid at all.
Mr. Shays. Why?
Dr. Hanna. We were offering to do it at our own costs.
Mr. Shays. You are confusing me. This has not been a great
day, so maybe it is my problem but be patient with me here. You
had a product that DOD helped you develop?
Dr. Hanna. They contracted with us to develop, yes.
Mr. Shays. They gave you money to develop the product. You
developed the product. Are they saying the product won't do the
job?
Dr. Hanna. No.
Mr. Shays. Are they saying the product costs too much
money?
Dr. Hanna. No. The project ended in 1997 and there was no
urgency and need for it.
Mr. Shays. But the project ended then but you still had the
capability to produce the product?
Dr. Hanna. We have had the capability from 1997 to now.
Mr. Shays. So why do you want me to be so confused here?
Dr. Hanna. I am not trying to.
Mr. Shays. There has to be a reason.
Dr. Hanna. I don't have an answer. I can think of no
reason. I thought there had to be a reason also.
Mr. Shays. This is a conversation we had somewhat privately
and I thought you would be able to publicly put on the record.
Dr. Hanna. I did at the suggestion of NIAID, Tony Fauci's
group, I did put in at their request an unsolicited proposal to
the CDC to make this product and it was rejected.
Mr. Shays. Did they give you a reason why?
Dr. Hanna. No, but they turned around and awarded the
contract to this foreign company which we heard today was
having extreme difficulties getting geared up to make the
product.
Mr. Shays. Dr. Davis, can you enlighten me about this
issue?
Dr. Davis. I am not sure I can enlighten you about his
issue, no. We have been facing a slightly different issue in
that the Government clearly appears to have some interest in
our product, it has been a long procurement process and as a
consequence, our concern is that the delay makes it very
difficult for us to plan and makes it very difficult for us and
other companies to be willing to develop from their own funds
products. There is a need for different procurement methods for
different things. There are clearly some products where the
Federal Government probably needs to fund the early research in
order to get it done but there are also other products and
other capabilities like ours where we have done the vast
majority of the research and the development on our own. What
we need is a commitment from the Government to buy the product
and we need a commitment to buy it in sufficient quantities
frankly to make it worthwhile. If somebody only wants a few
thousand doses, we are not going to start a large scale
manufacturing facility and dedicate 3 to 4 months of
manufacturing capability to make a few thousand doses. If they
want 100,000 doses, that starts to get economically reasonable.
If they want 200,000 doses, it makes a lot of sense. For us to
go into future products or other companies like us to go into
future products, you need to state up front what is really the
need of the Government. They have told us they want an anthrax
antibody but never told us how many doses they really want,
never told us what schedule they really want it on and so we
are left in a quandary of how we develop this product. We have
other pharmaceutical products competing.
Mr. Shays. Do you think they have told other companies what
they want?
Dr. Davis. No, no. I don't think they are being
disingenuous here, I think they are in a quandary about what
they want or maybe they know and haven't specified. The RFP
asks us to bid on prices for doses between 10,000 doses and
200,000 doses. That is a tremendous difference in how you
manufacture.
Mr. Shays. So you give them a bid at 10,000 and a bid at
50,000, a bid at 100,000, a bid at 15,000.
Dr. Davis. That is exactly what we have done.
Mr. Shays. So what is difficult about that?
Dr. Davis. The problem is that the manufacturing needs to
be planned 12 to 18 months ahead of time.
Mr. Shays. That is another issue but the bidding issue
isn't there.
Dr. Davis. No, we can bid. It's very difficult to know,
however, if you see that RFP and they are really only thinking
about 10,000 doses, we may not want to play. It is simply not
enough economic incentive even if we charge astronomical
amounts for 10,000 doses.
Mr. Shays. Is it that difficult to do a bid response? In
other words, you price the 10,000 at such an extreme price that
you are not in the running but you give them a price?
Dr. Davis. And we have done that.
Mr. Shays. So that is not really the issue. With all due
respect, that is not the issue.
Dr. Davis. It is an issue in terms of are we going to go
after another project like this, are we going to use our own
money to do the research and development on another project if
we are not sure what the Government needs?
Mr. Shays. Let me ask you, do you do the research before
you do the bid or do you do the bid before you do the research?
Dr. Davis. In this case, we did the research before the bid
because we thought there would be a market. I think in the
future, we are unlikely to do anything more in this area
without a clear indication of what they want in terms of
quantities.
Mr. Shays. What is the statement you agreed with most and
the statement you disagreed with the most and who made that
statement?
Dr. Davis. Dr. Fauci I think made the statement that I
agree with the most that this does have to be a partnership
between the Government and industry. The Government does not
have the capability to do large scale manufacture of these
products. It is very expensive, takes very specialized
facilities but we do need a partner in the Government so we
know what we are doing and when they want it and what it is.
I think it is hard to say there is a single statement I
disagree with. I think I am concerned that the procurement
process for the BioShield as described is not going as smoothly
as some may think. I think it still has a lot of work to be
done to make it more efficient, there are a lot of contract
provisions, a lot of indemnity and liability issues that are a
hurdle for companies to be willing to go across in order to
enter this market.
Mr. Shays. Thank you.
Mr. Marchant. I have a couple questions and they will be
questions broached from a freshman in the Congress, just a
couple of elementary questions.
If the Government came to you tomorrow and said we want
200,000 doses of this, how long would it take you to produce
them?
Dr. Davis. We would be able to start production in
approximately 12 to 18 months, but it would take us probably 6
months, maybe a year to produce all those doses but they would
be in a rolling batch. We could have doses available. For
example, if they told us today they wanted 200,000 doses, we
could certainly have doses for them at the beginning of 2007
and all the doses by the end of 2007.
Mr. Marchant. How much public knowledge would be available
about the amount of doses and the antibody that was being
produced?
Dr. Davis. I would presume, and speak with a little
ignorance here, that the contract would be public and the
number of doses they requested would be specified. The precise
structure of the antibody and the nature of the antibody we
have been fairly careful not to make public for security
reasons but some of that would depend on the Government's
desire to keep it secret or not.
Mr. Marchant. From someone that thinks the Government or
some entity has an antibody for any of these diseases can be
introduced in any form in the water system, through milk, etc.,
do you feel the American citizen has a security that there are
vaccines, antibodies and things available immediately that can
be introduced that can combat these things or are they aware
that we are studying this?
Dr. Davis. I think it depends on the particular agent you
are talking about and the particular means of which the product
is distributed and how you can treat it. In many cases, there
are inadequate therapies today. In some cases, there are some
therapies which may be adequate in some circumstances and not
in others.
Mr. Marchant. Obviously the general knowledge of the cure
will make sure whatever entity decides to introduce this into
society will not introduce that?
Dr. Davis. There is a strong deterrent effect one would
think from having stockpile of an efficient deterrent.
Dr. Hanna. The best offense is a good defense in this case,
clearly.
Mr. Marchant. So if DOD or whatever entity decided they
needed to have sufficient vaccine on hand to combat, how
prepared are we at this moment for those diseases that could be
introduced?
Dr. Hanna. You are not. For most of them, you are not
prepared.
Mr. Marchant. You in your case were paid to develop one but
you were not paid to produce the doses?
Dr. Hanna. Let me try to clarify one thing. When we stopped
making it, we closed down our manufacturing facility. We
recognize one of the problems and why we might have been
discriminated against is because our manufacturing facility
didn't exist, so we went back and said, we will volunteer with
private funds to build that manufacturing facility again and
within 18 months we will deliver to you 50,000 doses that meet
the specs, that would be FDA-approved again as we did
previously for emergency use and we would get it fully licensed
eventually.
I think at that time, they decided it would be better to go
to another contractor that had a facility and underestimated
the degree of scientific capability required because you heard
Simonson say that it is not only science, there is a bit of an
art to it and it is, there is an art to it. It is not something
that everybody can do. This contractor is working very hard, I
am sure, but they are not able to accomplish it yet. They will
eventually.
Mr. Marchant. They own the formula?
Dr. Hanna. We have the patent on the procedure.
Mr. Marchant. So they have to deal with you?
Dr. Hanna. We have not discussed that with them but my
point is it would have been better, it would have been smarter
to let them go and have the security of the contract they
managed and release us with a commitment that if we did what we
said, they would purchase from us at a fair price. Then you
would have had both competing with each other. That would have
been the smartest way to do it. Instead, they went the contract
route, which is the one they know the best.
All I am saying is we need to start some competition
however we do it, whether we do it with multiple contracts, a
contract versus an independent operation, with a commitment
letter. We couldn't raise the money without the commitment
letter. All we wanted was a letter saying if you do it, we will
buy it at a fair price to be negotiated.
Mr. Marchant. Mr. Counsel. Chairman Shays.
Mr. Shays. If you both were running the program, how would
you run the program? When I say program, we have agricultural
needs, we have plant needs, animal needs, we have human needs,
so it makes sense you would have three separate tracks,
correct, for each of those?
Dr. Hanna. Yes.
Mr. Shays. How would you run the program differently? If
you were in charge of this program, suppose the United States
says, I want you to run this program, tell me how you are going
to run it, what would you say?
Dr. Hanna. I would do it basically as I described. Let us
deal first with the biological. We know what the agents are.
Smallpox is pretty well covered, we have plenty of vaccine for
smallpox. What we don't have is vaccine for the other nine
agents or some kind of a therapeutic.
Mr. Shays. When you say agent versus therapeutic, with
anthrax there is one element that prevents it from catching
hold and another is you have it and now how you deal with it.
Is that your difference when you talk about agent versus
therapeutic?
Dr. Hanna. I am talking about a vaccine that would protect
you versus a therapeutic that you would take after you had
contact and in some cases, there will be no vaccines. The
botulism vaccine they were talking about was AB. Those are the
two common forms. If anyone was going to use an agent, it
wouldn't be AB. That is the most common and they know that.
They would use C through G and those are the most difficult to
defend against.
I would rank them and I would do just what I said. I would
set up multiple awards. I would either allow companies to come
in and give them commitment letters that if they do it, we will
purchase it or I would set up a contract and an award at the
same time. I would do what we do in the pharmaceutical
industry. Oftentimes, when new projects are started, we set up
two, maybe three groups and let them compete.
Mr. Shays. That sounds more expensive to me.
Dr. Hanna. It is a lot more expensive to go with the low
bitter and come up 7, 8 or 9 years later with the vaccines we
have seen from JVAP.
Mr. Shays. You are saying, get more companies and
individuals involved, you will get a product sooner, it is
going to cost you more, but we won't be where we are now with
nothing?
Dr. Hanna. How do you compare the cost when you have a
situation where you have nothing and still the threat is equal
to what it was 5 years ago?
Mr. Shays. What I am hearing you say in a sense is that by
doing it this way, it is taking longer which means we remain
vulnerable when we don't have to remain vulnerable. Your view
would be that we would get there sooner with a better product
if we had multiple competition?
Dr. Hanna. And build in redundancies. That is the thing
missing here, redundancies. You have a JVAP program with no
redundancies backing it. The one redundancy for the anthrax
vaccine, they can't even award it yet. This would be a
redundancy to what is in the JVAP program. You can't get them
to make a decision. I think the problem is the legislation is
written to favor the status quo which is to do it through
grants and contracts, and grants and contracts allow you to
give a contract for a particular project. I am saying set up
competition.
In NASA, they had a redundancy for everything, everything
had a backup. That is how they got to the moon and got back but
that was a Presidential mandate that said make it happen. We
are doing it in the standard way and I think we have to start
thinking out of the envelope.
Mr. Shays. I hear you and I understand now what you were
trying to tell me. It finally sunk in. Thank you.
Dr. Davis.
Dr. Davis. I think that is main thing I would change.
Mr. Shays. You are running the program.
Dr. Davis. I am running the program. I think the way I
would set it up is one, I would be very clear and they have
been, these are the agents, the terrorist weapons that we are
most concerned about and I would then give a clear indication
of what is the amount of need for product and then I would put
out an RFP but I would streamline the bureaucratic process. I
would use simplified contracting methods, I would try to bring
pressure to get the time lines down to much less.
Fourteen months for RFI to still have a contract
negotiation is a long time and we have been waiting simply for
the contract before we even begin our manufacturing. So if you
can streamline that process, you will get these products on
line sooner. If you have a clear, up front commitment,
streamlined process, I think you will find more industry
interest in participating in these sorts of programs because
then you can do a real measure of the net present value of this
project and understand whether it is worth your investment or
not.
Mr. Shays. The way counsel is responding to my question to
him as you were talking about what you were saying was that you
would use the more traditional system but make sure there was a
pot of gold and incentive.
Dr. Davis. Yes.
Mr. Shays. You would have an incentive but you would have a
competitive process and both of you would deal with speeding up
the time process?
Dr. Hanna. Of course.
Dr. Davis. Yes.
Mr. Shays. When you heard what was said today, is your
emotion just disappointment, disgust? The reason I am asking is
I am trying to figure out how I should feel about this. Is it
just give me a break or is it something like, you know what,
this is going to happen, we are vulnerable and you guys are at
fault in the end. Tell me what level of feeling you have right
now.
Dr. Hanna. My level of feeling is disappointment. It has
been a lot of energy. I think everybody at this table has done
their darnedest to get the job done. I have known people in the
agencies who came in thinking they could get the job done and
then ran into so many obstacles that they ended up leaving.
We walked away from it and decided we are not going to get
involved and do this thing because we couldn't, we couldn't get
it done. So it is disappointment. I think the disappointment is
that while there was an urgency and while there was a concern,
we didn't come up with enough creative mechanisms to get the
job done and we allowed each agency to funnel through their own
process, muddle through their own process individually. This is
an interdisciplinary need. You need a lot of people to get this
job done. You need industry, you need the Government agencies,
and you need people who are highly motivated and have a reason
for being motivated.
I would say disappointment and encouragement that looking
forward that you had this hearing and maybe we will get
something done and something will come out of it.
Mr. Shays. Let me say in regards to that, we may end up
having a private meeting with the folks I didn't get to
question but we know we need to do something different and we
need to move this along more quickly.
Dr. Davis, your emotion?
Dr. Davis. I think my emotion continues to be a certain
amount of frustration. I believe the agencies are very
dedicated to getting this done. I think their hearts and their
minds are in the right place. I think they have not been able
to motivate the bureaucracy to move and we need to find a way
to make this a more efficient process. Otherwise, you are going
to end up with more companies like mine who are frustrated and
simply aren't going to play.
Mr. Shays. Thank you, Mr. Chairman. Thank you both very
much.
Mr. Marchant. The subcommittee is adjourned.
[Whereupon, at 3:59 p.m., the subcommittee was adjourned.]
[The prepared statements of Hon. Dennis J. Kucinich, Hon.
C.A. Dutch Ruppersberger, and Hon. Bernard Sanders follow:]
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