[House Hearing, 107 Congress]
[From the U.S. Government Printing Office]



 
  BIOLOGICAL WARFARE DEFENSE VACCINE RESEARCH AND DEVELOPMENT PROGRAM
=======================================================================

                                HEARING

                               before the

                   SUBCOMMITTEE ON NATIONAL SECURITY,
                   VETERANS AFFAIRS AND INTERNATIONAL
                               RELATIONS

                                 of the

                              COMMITTEE ON
                           GOVERNMENT REFORM

                        HOUSE OF REPRESENTATIVES

                      ONE HUNDRED SEVENTH CONGRESS

                             FIRST SESSION

                               __________

                            OCTOBER 23, 2001

                               __________

                           Serial No. 107-105

                               __________

       Printed for the use of the Committee on Government Reform


  Available via the World Wide Web: http://www.gpo.gov/congress/house
                      http://www.house.gov/reform



                             _____________





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                     COMMITTEE ON GOVERNMENT REFORM

                     DAN BURTON, Indiana, Chairman
BENJAMIN A. GILMAN, New York         HENRY A. WAXMAN, California
CONSTANCE A. MORELLA, Maryland       TOM LANTOS, California
CHRISTOPHER SHAYS, Connecticut       MAJOR R. OWENS, New York
ILEANA ROS-LEHTINEN, Florida         EDOLPHUS TOWNS, New York
JOHN M. McHUGH, New York             PAUL E. KANJORSKI, Pennsylvania
STEPHEN HORN, California             PATSY T. MINK, Hawaii
JOHN L. MICA, Florida                CAROLYN B. MALONEY, New York
THOMAS M. DAVIS, Virginia            ELEANOR HOLMES NORTON, Washington, 
MARK E. SOUDER, Indiana                  DC
STEVEN C. LaTOURETTE, Ohio           ELIJAH E. CUMMINGS, Maryland
BOB BARR, Georgia                    DENNIS J. KUCINICH, Ohio
DAN MILLER, Florida                  ROD R. BLAGOJEVICH, Illinois
DOUG OSE, California                 DANNY K. DAVIS, Illinois
RON LEWIS, Kentucky                  JOHN F. TIERNEY, Massachusetts
JO ANN DAVIS, Virginia               JIM TURNER, Texas
TODD RUSSELL PLATTS, Pennsylvania    THOMAS H. ALLEN, Maine
DAVE WELDON, Florida                 JANICE D. SCHAKOWSKY, Illinois
CHRIS CANNON, Utah                   WM. LACY CLAY, Missouri
ADAM H. PUTNAM, Florida              DIANE E. WATSON, California
C.L. ``BUTCH'' OTTER, Idaho          ------ ------
EDWARD L. SCHROCK, Virginia                      ------
JOHN J. DUNCAN, Jr., Tennessee       BERNARD SANDERS, Vermont 
------ ------                            (Independent)


                      Kevin Binger, Staff Director
                 Daniel R. Moll, Deputy Staff Director
                     James C. Wilson, Chief Counsel
                     Robert A. Briggs, Chief Clerk
                 Phil Schiliro, Minority Staff Director

 Subcommittee on National Security, Veterans Affairs and International 
                               Relations

                CHRISTOPHER SHAYS, Connecticut, Chairman
ADAM H. PUTNAM, Florida              DENNIS J. KUCINICH, Ohio
BENJAMIN A. GILMAN, New York         BERNARD SANDERS, Vermont
ILEANA ROS-LEHTINEN, Florida         THOMAS H. ALLEN, Maine
JOHN M. McHUGH, New York             TOM LANTOS, California
STEVEN C. LaTOURETTE, Ohio           JOHN F. TIERNEY, Massachusetts
RON LEWIS, Kentucky                  JANICE D. SCHAKOWSKY, Illinois
TODD RUSSELL PLATTS, Pennsylvania    WM. LACY CLAY, Missouri
DAVE WELDON, Florida                 DIANE E. WATSON, California
C.L. ``BUTCH'' OTTER, Idaho          ------ ------
EDWARD L. SCHROCK, Virginia

                               Ex Officio

DAN BURTON, Indiana                  HENRY A. WAXMAN, California
            Lawrence J. Halloran, Staff Director and Counsel
              Kristine McElroy, Professional Staff Member
                           Jason Chung, Clerk
                    David Rapallo, Minority Counsel







                            C O N T E N T S

                              ----------                              
                                                                   Page
Hearing held on October 23, 2001.................................     1
Statement of:
    Johnson-Wineger, Anna, Deputy Assistant to the Secretary of 
      Defense for Chemical/Biological Defense Programs, 
      Department of Defense......................................    66
    Kingsbury, Nancy, Managing Director for Applied Research and 
      Methods, General Accounting Office, accompanied by Janet 
      Heinrich, Director, Health Care-Public Health Issues; 
      Sushil K. Sharma, Assistant Director for Applied Research 
      and Methods; and Jack Melling, consultant..................    81
    Sudovar, Stephen G., president and chief executive officer, 
      Elusys Therapeutics, Inc., and Una S. Ryan, president and 
      chief executive officer, Avant Immunotherapeutics, Inc.....    95
    Thompson, Tommy G., Secretary, Department of Health and Human 
      Services...................................................     9
Letters, statements, etc., submitted for the record by:
    Johnson-Wineger, Anna, Deputy Assistant to the Secretary of 
      Defense for Chemical/Biological Defense Programs, 
      Department of Defense, prepared statement of...............    70
    Kingsbury, Nancy, Managing Director for Applied Research and 
      Methods, General Accounting Office, prepared statement of..    83
    Ryan, Una S., president and chief executive officer, Avant 
      Immunotherapeutics, Inc., prepared statement of............   109
    Shays, Hon. Christopher, a Representative in Congress from 
      the State of Connecticut, prepared statement of............     3
    Sudovar, Stephen G., president and chief executive officer, 
      Elusys Therapeutics, Inc., prepared statement of...........    99
    Thompson, Tommy G., Secretary, Department of Health and Human 
      Services, prepared statement of............................    15


  BIOLOGICAL WARFARE DEFENSE VACCINE RESEARCH AND DEVELOPMENT PROGRAM

                              ----------                              


                       TUESDAY, OCTOBER 23, 2001

                  House of Representatives,
Subcommittee on National Security, Veterans Affairs 
                       and International Relations,
                            Committee on Government Reform,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 10 a.m., in 
the Hubert H. Humphrey Building, Hon. Christopher Shays 
(chairman of the subcommittee) presiding.
    Present: Representatives Shays, Sanders, Putnam, Lantos, 
Kucinich, Tierney, and Weldon.
    Staff present: Lawrence Halloran, staff director and 
counsel; Robert Newman, Kristine McElroy, and Thomas Costa, 
professional staff members; Nicholas Palarino, senior policy 
advisor; Jason Chung, clerk; David Rapallo, minority counsel; 
and Earley Green, minority assistant clerk.
    Mr. Shays. I'd like to call this hearing to order, and to 
welcome our witnesses and our guests.
    On behalf of the entire subcommittee I want to thank 
Secretary Thompson for enabling us to hold this field hearing 
in the Humphrey Building this morning. Through their 
unhesitating willingness to help us go forward, despite 
continued closure of the House Office buildings, the Secretary 
and his extraordinary staff demonstrating once again as they 
have so many times since September 11th their determination to 
conduct the Nation's business despite enormous challenges.
    We convene this hearing in an unaccustomed place to discuss 
an unprecedented need for vaccines to protect against the most 
unnatural outbreaks of disease imaginable, biological 
terrorism. In reaching beyond familiar places and customary 
ways of doing business, we heed the wise counsel of Abraham 
Lincoln who advised a Nation facing the terror of civil war 
that, ``The dogmas of the quiet past are inadequate to the 
stormy present. The occasion is piled high with difficulty and 
we must rise with the occasion. As our case is new, so we must 
think anew and act anew. We must disenthrall ourselves and then 
we shall save our country.''
    Thinking anew requires confronting hard, new realities. 
There is no absolute immunity to biological attack. Nature's 
varied and virulent arsenal of pathogens will always outnumber 
and out-gun our immunological defenses. The prospect of 
genetically engineered organisms only compounds our peril.
    Still many people are justifiably concerned. We seem 
medically unprepared to deter or defend against attacks using 
agents anthrax and smallpox, long considered likely terrorists 
for biological warfare weapons. Almost 2 years ago, this 
subcommittee found the Department of Defense [DOD], anthrax 
vaccine immunization program overtly dependent on the sole 
source manufacturer of a dated, logistically cumbersome medical 
technology. We recommended the mandatory, force-wide program be 
scaled back while a new, more easily manufactured and more 
easily administered vaccine was developed.
    Those recommendations were not followed. Today, as the 
threat of anthrax infection has become a grim reality, we 
remain without adequate supplies of either the old or a new 
anthrax vaccine. Witnesses today will address what is being 
done in the short and long term to provide greater protection 
against anthrax attacks.
    The current stockpile of smallpox vaccine is very limited 
and very old. A recent exercise entitled, ``Dark Winter'' 
modeled the extreme, but nonetheless plausible, scenarios of a 
multi-site smallpox attack. The exercise vividly demonstrated 
the critical importance of the right amount of vaccine, at the 
right place, at the right time to protect the public health. 
While hopefully still a remote possibility, the potentially 
catastrophic consequence of a smallpox outbreak have prompted 
accelerated efforts to develop new vaccines against the highly 
contagious viral disease.
    The anthrax and smallpox vaccine development efforts, and 
others underway, raise important questions about the future of 
our national bioterrorism preparedness. How much should current 
regulatory standards be modified to accommodate development and 
production of new vaccines? How can the effectiveness of new 
immunizations be demonstrated when there is no naturally 
occurring disease to test against? It is not ethical to expose 
otherwise healthy people to lethal pathogens.
    In the event an outbreak occurs before a biological defense 
is fully approved, how will those receiving the inoculation be 
informed they are using an investigational product? If the 
official risk/benefit calculation degenerates into little more 
than ``anything is better than nothing,'' how will the public 
be protected from the flood of useless potions and magic anti-
terrorism elixirs sure to appear on the Internet?
    To address these questions, we are fortunate to be able to 
call upon the Secretary of Health and Human Services, Tommy 
Thompson. Representatives from the Department of Defense, the 
General Accounting Office and the vaccine industry will also 
give us the benefit of their expertise and insights.
    I'd like to welcome again our witnesses, and Secretary 
Thompson, in a second we'll swear you and hear your testimony. 
But I would like to call on our members, first our senior 
member and the ranking member of the International Relations 
Committee, Mr. Lantos.
    [The prepared statement of Hon. Christopher Shays follows:]
    [GRAPHIC] [TIFF OMITTED] 81780.001
    
    [GRAPHIC] [TIFF OMITTED] 81780.002
    
    Mr. Lantos. Thank you very much, Mr. Chairman.
    Let me first commend you for your extraordinary leadership 
during the course of many years in calling our attention to 
critical issues facing the American people. If there is any 
member of people who deserves high praise, it's Christopher 
Shays. And I'm delighted publicly to pay tribute to you.
    Mr. Shays. Excuse me. I'm just going to once again 
encourage people to turn off their phones, if that's what we're 
hearing right now. Thank you.
    Mr. Lantos. Mr. Chairman, this past weekend I had several 
of my grandchildren visiting me. I took them to the Roosevelt 
Memorial. The Roosevelt Memorial has a number of remarkable 
statements made by our great, late President. The one that has 
been quoted ad nauseam and ad infinitum, and accurately, is 
that we have nothing to fear but fear itself. But I found among 
the quotes at the Roosevelt Memorial another one which is 
singularly apropos to our hearing this morning. I would like to 
focus my opening remarks on that other quote.
    It basically says that society should not exert itself on 
behalf of the few who have too much, but should do its utmost 
to help the many who have too little. Now, this has a very 
contemporary ring, because earlier this year we dealt with a 
major tax package. And the one issue which we have not yet 
approached seriously, following September 11th, is the 
imperative need in our society to revisit the lopsided tax 
package that provided enormous benefits for the wealthiest 
amongst us and very little for the people who are in the low or 
middle income brackets.
    Now, we are looking at everything anew following September 
11th. The cliche is that this is a whole new world. But the one 
thing that has received very little attention is the need to 
revisit the allocation of the basic resources of this society. 
I find that in a sense, this became quite obvious when Members 
of Congress were given far quicker response than employees of 
the U.S. Postal Service when we faced this particular crisis.
    And I would like to suggest to all of us on the 
congressional panel here, and to all of our colleagues, that 
since very few of us understand the technical complexities of 
the issues we deal with in this entire field, our 
responsibility is to deal with policy issues. Mr. Secretary, 
yesterday the president of the American Public Health 
Association criticized the administration's program of $300 
million and called for a minimum of a $1 billion in this field.
    This is just the beginning of a whole range of gigantic 
demands on the public purse. Congress has shown itself more 
than willing to step up to the plate and to vote any amount we 
need to provide security for the American people. But the time 
has come to re-examine an initially misguided tax package which 
now looks nothing short of obscene. The American people will 
simply not stand for re-examining old ramifications of our 
lives following September 11th, but not touch a tax package 
which so unfairly and in a singularly inappropriate fashion, 
singles out the wealthiest amongst us for benefits.
    I would very much hope that you will use your influence 
within the Cabinet, and you have a great deal of influence, and 
I can assure you, many of us will use our very limited 
influence at the White House to deal with this issue. Because 
the full range of requirements, way beyond the issue we are 
discussing this morning, will have to have the support of the 
American people and it will not have that support unless there 
is a feeling of fairness in terms of sacrifice, contribution 
and commitment.
    Thank you, Mr. Chairman.
    Mr. Shays. I thank the gentleman. Mr. Putnam.
    And let me thank the gentleman, the vice chairman, who has 
been very active on this committee and played a major role.
    Mr. Putnam. Thank you, Mr. Chairman. I want to thank you 
for the leadership that you have shown in holding a number of 
hearings on terrorism and on bioterrorism. I welcome our 
distinguished panel, although I am curious as to what they can 
contribute to our discussion on tax policy and the previous 
legislation that the Congress has taken up and passed out with 
overwhelming support regarding the Nation's tax policy.
    We're here to discuss the biological threats that are out 
there, the status of the threat that this Nation faces and how 
equipped we are to deal with an outbreak. And that's something 
that Secretary Thompson has a great deal of experience in and 
has certainly gained a great deal more in in the previous 
several weeks.
    We have had a number of hearings that have pointed out some 
of the shortcomings of our Government's preparedness and the 
limited capacity to produce sufficient quantities of vaccine, 
and we look forward to hearing the status of that production 
capacity. We are in a new world, we are in a new situation 
where together, pulling in the same direction, moving toward 
the common goal, we can assure the public that we are 
adequately prepared, that we do have sufficient stockpiles of 
vaccine, that we have developed adequate protocols of 
prophylaxis and treatment to meet this new threat. And that's 
what it is, a new threat.
    I think that it will require new resources. It will require 
reprioritization of what had been the direction that the 
Government and the budget policies were taking. But I do take 
some exception to the fact that an accusation has been laid out 
that the Congress has somehow been treated differently. Every 
American should know that they have access to the best health 
care system in the world, headed up by the most dedicated 
professionals from the CDC level right down to the local 
hospital.
    The background that this committee has developed through a 
succession of hearings has established that we do have the 
finest public health system, and there are ways for us to 
continue to reinforce the effort that those hard working men 
and women put into this, improving surveillance techniques, 
improving the dissemination of information, to be on the 
lookout for things like anthrax and smallpox and botox and 
bubonic plague. Those are areas where hopefully together we can 
continue to take this hearing, working hand in hand with the 
administration, with both sides of the aisle, with both 
chambers, to move forward to the American people.
    With that, I yield back the balance of my time.
    Mr. Shays. I thank the gentleman.
    I would call on Mr. Sanders, who has been with this 
committee at almost every hearing, and I thank the gentleman.
    Mr. Sanders. And I thank you, Mr. Chairman, for the 
leadership that you've shown in this whole area, and we welcome 
the Secretary to be with us today.
    As the chairman indicated when he began, we are meeting in 
an unusual facility for us, at an unusual time and dealing with 
a subject that I think many of us would have hoped never to 
have to deal with. But I think as Americans, and as the U.S. 
Government, it is imperative for us now to take the hardest 
look that we can at the most nightmarish situations that we can 
imagine. I think that's what the American people want, and they 
want us to come up with the best solutions that we can come up 
with. This is not pleasant, we're not happy about it, but 
that's something that we have to do.
    Let me tell you just very briefly some of the areas that I 
am concerned about. No. 1, that in fact we have to lay out what 
the plans may be of fiendish minds who want to destroy 
Americans. And it's not a pleasant intellectual scenario to get 
into, but we have to do that. And then we have to determine 
from a counter-terrorism point of view, how can we prevent the 
implementation of those plans.
    There is in the report information that we have received 
from the committee indications that a 1993 report by the U.S. 
Congressional Office of Technology Assessment estimated that 
between 130,000 and 3 million deaths could follow the 
aerosolized release of 220 pounds of anthrax spores upwind of 
the Washington, DC, area. In other words, it is conceivable 
that somebody flying in a two-seat passenger plane can do 
horrendous damage to this country. How do we stop that? Very 
difficult. But questions that we have to got to ask.
    In the event that a tragedy occurs, how do we make certain 
that our people are immunized? If people become sick, what 
procedures are in place to treat them? The truth of the matter 
is, and let me disagree with my friend a moment ago who talked 
about our system being the strongest in the world. In many 
ways, we are not the strongest health care system in the world. 
If, God forbid, a disaster struck us today in a large city, do 
we really believe that millions of people know where to go, in 
a short period of time to get the medicine that they need?
    We have 44 million people who have no health insurance 
whatsoever. We have tens of millions of people who don't know 
who their physician is. We do not, in fact, have a strong 
public health infrastructure in this country, and I think we 
should use this crisis to build one. So that if, God forbid, 
there is a tragedy, and if we are able, and I'm sure the 
Secretary will talk about this, get the medicine and the drugs 
out to people, to make sure that those drugs are distributed in 
a way that people can calmly receive them, rather than develop 
a sense of panic about where they go and so forth.
    The other issue that I want to touch upon, Mr. Secretary, 
and you know that this is an issue of deep concern to me, is 
the role of the pharmaceutical industry in this whole 
situation. I am concerned and have been concerned for years 
that the pharmaceutical industry remains, year after year, the 
most profitable industry in this country, and that they charge 
the people in the United States by far the highest prices in 
the world.
    Now, that may be a discussion for another day. But what is 
appropriate today, if we are dealing with Cipro, and if we are 
dealing with vaccines, it is incumbent upon our Government to 
tell the pharmaceutical industry that they can forget about 
their profits, that we need that product, as much of that 
product as we need, as quickly as possible, and we need it at a 
cost that is affordable to individuals and to the U.S. 
Government.
    You are aware, no doubt, that the Canadian Government said 
to Bayer, I guess, the manufacturer of Cipro, thank you, but no 
thank you, we will do it generic. My understanding, and you can 
correct me if I'm wrong, that in India, there is a generic that 
sells for 3 cents a pill, compared to what an American 
consumer, the $4 or $5 that an American consumer would pay 
going to a drug store here. Now, if that is true, there is 
something to be learned from that. My point here, sir, is that 
we've got to protect the American people and not pharmaceutical 
industry profits, and we've got to tell them to come on line 
and work with us.
    So there are a whole lot of issues out there, this is an 
uncharted territory. I know that you, Mr. Secretary, are 
working as hard as you can, and we will work with you. And 
let's see if we can go forward to make sure that the American 
people have the protection to which they are entitled.
    Mr. Shays. Thank you. At this time, then we'll get to you, 
Mr. Secretary, I will recognize the ranking member of the 
committee, Mr. Kucinich.
    Mr. Kucinich. Thank you very much, Mr. Chairman, for 
calling this hearing and I appreciate the work that you have 
done over the many years in calling this country's attention to 
the challenges that could be presented by biological warfare.
    While I intend to be fully involved in the questioning, I'd 
like to confine my remarks to kind of like the climate that 
we're in. Last week, Congress left the Capitol under the threat 
of a biological attack, anthrax. And I think that the American 
people at this time are looking for stability from their 
Government, they're looking for certainty from their 
Government, and we're going to have to do the best we can to 
provide that.
    We have to keep in mind that despite the fact that we have 
had buildings that have been contaminated, that this is a 
government of the people, not a government of buildings. And we 
can decontaminate buildings, we can make sure that buildings 
are secure. But we can never lose that commitment to government 
of the people and be cowered by terrorists or panicked, or turn 
against each other in moments of uncertainty.
    The underlying and fundamental unity which created this 
country is a good place for us to always begin from, whether 
we're Democrats or Republicans, whether we're Congress or the 
administration. We have to appeal to that fundamental unity, 
the thing that holds us together as a Nation, so that there 
will be no challenge that will be so great that it cannot be 
met without splintering this Government or this country.
    I have confidence that this administration and this 
Congress will work together to meet the challenge of dealing 
with biological, chemical or any other kind of terrorism. But 
we must be resolute in our intention to see that those 
principles of government of the people are not shaken to their 
foundation in moments of uncertainty and even panic. We're a 
stronger country than that.
    So with that in mind, and in that spirit, I look forward to 
hearing from the witnesses, and look forward to this 
opportunity to see what we may be able to do to better secure 
our Nation. Thank you very much.
    Mr. Shays. Thank you.
    You're a patient man, Mr. Secretary, and you are someone 
who fortunately is where you are. What we will do is just take 
care of this business, and we'll swear you in, we'll hear from 
your statement. I just need to ask unanimous consent that all 
members of the subcommittee be permitted to insert their 
prepared statements into the record and that the record remain 
open for 3 days for that purpose.
    Without objection, so ordered. And I ask further unanimous 
consent that all witnesses be permitted to insert an opening 
statement into the record, and that the record remain open for 
3 days for that purpose.
    Mr. Secretary, with you is Dr. Anthony Fauci from NIH and 
Dr. Scott Lilibridge, Special Assistant for Bioterrorism from 
your office, I believe. We'll ask all three of you to stand and 
we'll swear you in and then we'll hear your statement. Thank 
you.
    [Witnesses sworn.]
    Mr. Shays. Mr. Secretary, thank you for honoring us with 
your presence. You have as much time as you'd like.

STATEMENT OF TOMMY G. THOMPSON, SECRETARY, DEPARTMENT OF HEALTH 
                       AND HUMAN SERVICES

    Secretary Thompson. Thank you very much, Chairman Shays. 
And let me echo what other members of the committee have 
already said, congratulations and thank you for your leadership 
in this area. It's very much appreciated by me personally, and 
I know by the Nation, and I thank you.
    I also want to thank Congressmen Kucinich and Sanders and 
Tom Lantos and Adam Putnam and appreciate your dedication. I 
appreciated all of your opening statements and I hope to 
respond to most of the things that have already been announced 
by the members. I thank you very much for being here.
    Thank you for inviting me to join you today, and thank you 
for coming down from the Hill to the HHS building. I will try 
to make you feel at home.
    The President and the entire administration are committed 
to preventing bioterrorism. Our rapid and effective reports and 
efforts on September 11th and the days immediately following 
have certainly demonstrated that commitment. Even before then, 
I had been working vigorously with Dr. Scott Lilibridge, who's 
the gentleman on my right, one of the Nation's leading experts 
on bioterrorism. I asked him to join my team and come up from 
CDC in Atlanta and have his office right next to my office on 
the sixth floor. Since June, he has become my special assistant 
for national security and bioterrorism on domestic 
preparedness.
    On my left is Anthony Fauci, who is of course the Director 
of NIH of Allergy and Infectious Diseases, and I believe, the 
foremost scientist in the world on vaccines. I believe he is 
eminently qualified to answer any and all questions dealing 
with that subject.
    That's characteristic of the seriousness with which the 
President of the United States and this administration have 
since taking office and taking the need for preparedness. That 
ability to respond has been tested on September 11th and more 
recently with the current anthrax investigations. Let me 
emphasize that we have worked together with our partners across 
all levels of Government, from the Federal Bureau of 
Investigation to the U.S. Postal Service, from local hospitals 
to county governments, to address these more recent terrorist 
events.
    And soon after the first case of anthrax exposure in 
Florida, the Department of Health and Human Services, through 
the CDC, alerted all public health departments in the country 
to be on the lookout for anthrax-like symptoms, including those 
associated with inhalation and cutaneous.
    As you know, anthrax is not contagious. Contracting 
inhalation anthrax, for example, is fundamentally different 
from exposure to the agent. You would have to inhale 8,000 to 
10,000 spores of anthrax into your lungs before actually coming 
down with the disease. So simply having anthrax spores in one's 
nose does not mean that you are infected with anthrax.
    The drug Ciprofloxin, commonly known by its brand name, 
Cipro, is effective in the treatment of inhalation anthrax, 
even after infection. And Representative Sanders, I want you to 
know that I made that crystal clear to Bayer, that we will not 
accept the price that they offered, and we will be negotiating 
this afternoon. I hope you will be satisfied with the outcome.
    We have taken and continue to take every precaution, and we 
have made Cipro available to the widest number of people 
suspected of being exposed to inhalation anthrax. But other 
drugs, such as Doxycycline and penicillin have been approved by 
FDA as treatments for anthrax, and they're generic. The FDA's 
approval will include instructions on what dose to use and how 
long to treat the inhalation form of anthrax.
    The CDC has asked the local hospitals in and around the 
Nation's Capital pay particular attention to any suspicious 
respiratory or skin infections. We at the Department have been 
monitoring hospitals in the area, and are closely monitoring 
the cases of two postal workers who are infected with 
inhalation anthrax in the District of Columbia. We're all 
deeply saddened by the deaths of two local postal employees 
whose deaths have been linked to anthrax. Our thoughts and 
prayers are with their families.
    And throughout the past month, the CDC and local public 
health departments have been working hard to trace back the 
source of the anthrax tainted letters that have been received 
in this country. They've used the best science to follow the 
trail of these letters, and they've used the best science to 
assess the risk of anthrax exposure to employees, both at the 
work places where the letters were received and at the postal 
facilities where the letters pass through.
    Public health officials are relying heavily on science as 
they track these letters, identify those who may have been 
exposed and determine a course of treatment. These efforts were 
evident in the Florida and New York cases, where the letters 
were identified and those who may have been exposed were tested 
and treated. The CDC has done a good job of finding the letters 
in question and getting treatment to those at risk. The work of 
the CDC has likely saved many from serious illness and death.
    We have good science. But it is also, ladies and gentlemen, 
an evolving science. Remember, we have never had cases of 
anthrax attacks in this manner before. It is a new challenge 
that we are all facing. We also need to get ahead of the 
science. We will be even more, gentlemen, aggressive in 
securing the safety of our postal workers who may have been 
exposed to a tainted letter. CDC, the Union and the Postal 
authorities are meeting this afternoon in order to find ways to 
better secure the safety of all employees.
    Therefore, I am making it clear today to this committee and 
to the American public, the Centers for Disease Control, that 
when a case of anthrax does emerge, we will immediately move in 
at any and all postal facilities that might have handled that 
piece of mail. We will build a scientific link between the post 
office of the postmark and the recipient of the letter.
    In other words, we'll not only immediately begin testing 
and treatment at the site where the letter was received, but 
simultaneously begin testing and treatment at all postal 
facilities through which that letter may have passed. And we 
will make medicine immediately available to those employees who 
may have been at risk of exposure. We have plenty of 
antibiotics to treat anthrax, and we're going to err on the 
side of caution in making sure people are protected.
    I ask for the cooperation and partnership of local public 
health departments in this endeavor. We're also going to lend 
the U.S. Postal Service our scientific expertise in developing 
ways to protect postal workers as they sort and deliver the 
mail, as well as what technology might help in making mail 
rooms more safe. We've been assisting the Postal Service from 
the onset, and we're going to continue to make our resources 
and expertise available to them. We're having a meeting this 
afternoon to finalize and be able to improve those terms.
    Postal workers have a tough job. It's a job that becomes 
even tougher in some parts of the country. But we're going to 
ease their burden by going to the greatest lengths to make sure 
that their health is protected. If we even remotely suspect 
that an anthrax tainted letter may have passed through a 
facility, we're going to get there, test the facility and make 
the appropriate treatment available to those who may have been 
exposed. We're going to act quickly and if need be, let the 
science catch up to our actions. If it turns out postal workers 
did not come in contact with anthrax spores, we can always take 
them off the antibiotics. Never has our Nation's public health 
surveillance been more important. And the dedicated public 
servants in the Department of Health and Human Services as well 
as the public health officials in all our local communities are 
committed to being even more thoroughly prepared to respond 
tomorrow than we are today.
    And I know, I know some critics are charging that our 
public health system is not prepared to respond to a major 
bioterrorism attack. And I know that some State and local labs 
are feeling overwhelmed right now as they respond to people's 
natural fears about what might be waiting in their mail. And I 
understand that our local first responders are also feeling 
overburdened. But the response from State and local authorities 
to each and every threat is continuing and will continue. And 
we should be proud of how well everybody has responded to 
events that have broken our hearts even as they have steeled 
our resolve.
    But we must continue our efforts to be better prepared for 
future events. So in an effort to ensure the Department is 
fully prepared and better coordinated, I recently announced the 
creation of a bioterrorism advisory committee in my office. And 
Dr. D.A. Henderson, who certainly is renowned for his role in 
eradicating smallpox, heads that committee. Dr. Henderson and 
his staff will provide seasoned advice to the Department on all 
bioterrorism activities including efforts to improve State and 
local preparedness.
    And just this last week, President Bush requested an 
additional $1.5 billion to strengthen our ability to prevent 
and respond to a bioterrorism attack. Of the total funds 
requested, two-thirds are being designated for the production 
of vaccines and antibiotics. In addition, the President has 
requested $300 million for improving State and local readiness, 
which specifically includes $122 million for training 
communities in distribution of the medicines during an 
emergency, Representative Sanders. We must accelerate the 
production of vaccines and antibiotics. And we must invest in 
essential programs to ensure the speedy and orderly 
distribution of antibiotics and other supplies in the event of 
a major bioterrorism event.
    The President's request includes $643 million to expand the 
national pharmaceutical stockpile and $509 million to speed the 
purchase of 300 million doses of smallpox. And with these 
resources, HHS will expand its program capabilities to respond 
to an all hazardous event.
    As you all know, there are currently eight Push Packs, each 
consisting of 50 tons of medical supplies, available as part of 
the stockpile. Each one includes no less than 84 separate types 
of supplies, things like antibiotics, needles and IVs, a tablet 
counting machine and oxygen masks. And each Push Pack provides 
a full course of antibiotics and other medical supplies, and is 
able to be shipped to an area within 12 hours to help State and 
local response efforts. We were able to deliver one Push Pack 
into New York City on September 11th within 7 hours.
    These Push Packs have enough drugs to treat 2 million 
individuals for inhalation anthrax following exposure. I have 
directed that the stockpile development should be increased for 
inhalation anthrax so that 12 million persons can be treated. 
The CDC will reach that level of response within the next 12 
months.
    I also want to point out the President signed an Executive 
order yesterday urging us to go ahead quickly on this program. 
With the additional resources, we will also add 4 more Push 
Packages to a total of 600 tons of medical supplies from the 
current 8, and have them strategically located across the 
country, making more emergency supplies available and 
augmenting our existing supplies.
    The President and my Department are also committed to the 
development and the approval of new vaccines and therapies. The 
CDC, the Food and Drug Administration and the National 
Institutes of Health, all agencies within HHS, are 
collaborating with the Defense Department and other agencies to 
support and encourage research to address the scientific issues 
related to bioterrorism. The capability to detect and counter 
bioterrorism depends to a significant degree on the state of 
relevant medical science. Our continuing research agenda, in 
collaboration with CDC, FDA, NIH and DOD is critical to our 
overall preparedness.
    So let me outline several other areas that our budget 
requests. The President is calling for $88 million to expand 
our capacity to respond to bioterrorism incidents, including 
$20 million for the CDC's rapid response and advanced 
technology and specialty labs, which provide quick 
identification of the suspected agents and the technical 
assistance to State labs. Also included in this amount as $20 
million to support additional expert epidemiology teams that 
can be sent to States and cities to help them respond quickly 
to infectious disease outbreaks and other public health risks.
    And let me reiterate my conviction, personally, that every 
State should have at least one federally funded epidemiologist 
who has graduated from the Epidemic Intelligence Service 
training program, like Scott Lilibridge has. Every State health 
department, I believe, should have one.
    The President is also asking for $50 million to strengthen 
the metropolitan medical response system, to increase the 
number of large cities that are able to fully develop their 
MMRS units. It is imperative that we work closely with cities 
to ensure that their MMRS units have the proper equipment and 
training, increasing that from 97 to 122.
    We're also providing $50 million to assist hospitals and 
emergency departments in preparing for and responding to 
incidents requiring mass immunizations and treatment. And we're 
providing $10 million to augment State and local preparedness 
by providing training to State health departments on 
bioterrorism as well as emergency response.
    The President is also requesting $40 million to support 
early detection surveillance to identify potential bioterrorism 
agents which includes Web-based disease notification to the 
health community nationwide. This amount will provide for the 
expansion of our Health Alert Network, more commonly referred 
to as HAN, which helps early detection of disease to 75 percent 
of the Nation's 3,000 counties. I wish and hope to have all 
counties connected in the coming years.
    We're providing $15 million to support the increased 
capacity in no less than 78 laboratories in 45 States. This 
funding will enhance our ability to identify and detect all 
critical biological agents, and we're implementing a new 
hospital preparedness effort to ensure that our health 
facilities have the equipment and training they need to respond 
to mass casualty incidents.
    Finally, as to food safety, the President is also 
requesting $61 million to enhance the frequency and the quality 
of imported food inspections, and to modernize the import data 
system to enable us to detect tainted food. This funding will 
also provide for 410 new FDA inspectors to help ensure that our 
food is better protected.
    The administration has sent to Congress legislation to 
strength our ability to protect the Nation's food supply. This 
measure will require prior notice of imported food shipments, 
enhancing our ability to inspect food, allowing for detention 
of food suspected of being tainted, and providing flexibility 
for the FDA to approve drugs and other treatments for dealing 
with illness resulting from biological attacks.
    Mr. Chairman, let me conclude by noting that despite the 
events of recent days, every American must and should continue 
to live their lives, working, spending time with family, having 
a meal out or shopping at the local mall. And they should be 
able to do that with confidence.
    American citizens can be sure that their government 
agencies, local, State and Federal, are ready to respond to 
biological warfare and bioterrorism quickly and effectively 
throughout the country. None of us enjoys contemplating 
bioterrorism. But as responsible public servants, doing so is a 
matter of fulfilling the public's trust in us. And under the 
leadership of President Bush, we're taking all the steps 
necessary to keep america safe in an era when biological and 
chemical attacks are as possible as they are unthinkable.
    I want to thank you, Mr. Chairman, for letting me speak 
about this matter of critical importance. And now I'm glad to 
answer your questions.
    [The prepared statement of Secretary Thompson follows:]
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    Mr. Shays. Thank you, Mr. Secretary, for your thorough 
statement.
    I again want to thank you for allowing us to use your 
facility and also thank you again for your presence here before 
the committee. It's the intention of the chairman to have 5 
minute questions for each Member and then we'll do a second 
round where we'll go 10 minutes if any Member wants to.
    I just want to set up the stage for my question. We've had 
three commissions that have come before our committee, the 
Gilmore Commission, the Bremey Commission, the Hart-Rudman 
Commission, and all of them have basically said to this 
committee and in their reports that we haven't had a proper 
assessment of the terrorist threat, that we don't have a 
strategy to deal with it, and we aren't organized effectively 
to implement a strategy. That's what they said last year, and 
obviously things have changed. You have a President who has put 
Tom Ridge in charge of reorganizing to maximize our effort.
    We recognize that the best thing that could happen is that 
we would detect and prevent an attack, whether it was 
catastrophic or sand in the gears, which is really what we have 
right now. We have in that process a crisis, if an attack is 
underway and how does the Government deal with it, and then we 
have, if an event occurs, we have the criminal justice system 
trying to discover where this attack happened, who's 
responsible and so on, and who do we hold accountable. I would 
parenthetically say, though, I view all this not as a criminal 
action, I view it as an act of war. I think we are at war.
    And then we come to what we call the crisis management, 
where FEMA comes into play and so on. I put you pretty much in 
that category of the crisis has occurred.
    Secretary Thompson. Right.
    Mr. Shays. And this hearing is to look at the role vaccines 
play in civilian preparedness. You're free to speak on 
anything, and obviously, the Members are free to ask anything 
they want. I know you'll respond as you choose.
    But one of the things we want to know is, what are the near 
and long term roles of vaccines in preparedness against 
biological warfare and terrorism, how adaptable is the current 
regulatory process to the development and approval of 
biowarfare defense vaccines? That's kind of the thrust of the 
hearing.
    So with that as the thrust, I'm interested to know, do you 
plan or are you recommending that we vaccinate the entire U.S. 
population for, say, a smallpox outbreak?
    Secretary Thompson. No, we do not. If I could just set my 
response a little bit longer than just that very quick 
response, if I might, Mr. Chairman. I want everybody to know 
that right now, as soon as a consequence happens, we would 
immediately put in order and put on notice our 7,000 
individuals that belong to our 90 DMAT teams throughout the 
United States.
    As soon as a crisis happens, they contact the State health 
department, who contacts CDC. We would send immediately some 
epidemiologists from Atlanta to that locale. And they would 
work in cooperation with the local hospital, the local 
emergency workers and the State health department to develop a 
plan.
    They would then call us with that plan. In the Humphrey 
building we've got a huge room downstairs set aside in which we 
have people like Scott Lilibridge and other professionals 
around. That's on the sixth floor and I hope you'll go down and 
look at it before you leave today, members of the committee. 
Then they would send out whatever they need as far as extra 
personnel, as well as medical supplies.
    In regard to your specific question on vaccination, we 
have, as you know, 15.4 million dosages of smallpox vaccine 
right now. And Dr. Tony Fauci is doing research right now to 
determine if we could dilute that down five to one or ten to 
one. Ten to one you would only have an effective rate of about 
70 percent. Five to one we think it's going to be around 90 
percent. And that would be very effective, 90 to 95 percent. We 
would then have 77 million dosages.
    That has been analyzed by Tony Fauci and the people out at 
NIH and they say it's very potent and very effective. We have 
enough diluent and needles to handle the 15.4 million dosage of 
smallpox.
    We are in the process, we sent out what is called a request 
for information, I met with the pharmaceutical companies, 
several of them last week, and seven companies now have 
indicated they would like to get involved in issuing some sort 
of a bid to produce smallpox vaccine.
    Mr. Shays. Could I just ask you in this regard, after 
you've done your experimentation with animals, you have to go 
through one phase where you do a handful of, a protocol on 
humans, for initial safety and to see how well it immunizes. 
Then you go to phase two, which could take 2 years to much 
longer, with several hundred patients, to determine the safety 
and efficacy. Then you go to phase three, where you're dealing 
with even more. It's hard for me to know how we can reach a 
timetable.
    Secretary Thompson. That's why Dr. Fauci is here, because 
we have already worked that out, Mr. Chairman.
    Mr. Shays. Let me just say, after you answer, and then I'll 
go to Mr. Kucinich.
    Dr. Fauci. Mr. Chairman, what we're talking about is trying 
to expand the availability and dosage of an already approved 
vaccine. So it's a different story from having to go to a new 
vaccine, we're talking about the dilution studies on the 
existing smallpox vaccine.
    Mr. Shays. Is this the vaccine that is----
    Dr. Fauci. In the stockpile--yes, absolutely. This is the 
highly effective vaccine that we used to vaccinate routinely 
until 1972, and in 1972 it was discontinued. We have 15.4 
million doses in the U.S. Government reserve. That is already 
an approved vaccine.
    The studies that were done preliminarily on 60 individuals 
compared a broad range of dilutions. We took the undiluted, 
which we know works, decades of history tell us it works, 
there's safety, obviously there are some issues we could 
discuss about the risk-benefit of that, because they are 
uncommon but nonetheless potentially serious toxicities with 
that.
    Mr. Shays. Let me just interrupt you a second, there, and 
say that though this is an older vaccine which is truly not as 
pure, it's there and it is approved.
    Dr. Fauci. Right.
    Mr. Shays. But aren't we ultimately looking to produce a 
new vaccine?
    Dr. Fauci. We are. There are----
    Mr. Shays. That's really what I was asking.
    Dr. Fauci. Exactly. We have an immediate plan to answer the 
question, what happens if something happens a month, a week, 3 
months from now, what happens if something happens 6 months to 
a year? And the Department under the Secretary's leadership has 
tasked us to put together a plan which addresses the immediate, 
the intermediate and the long range. The question you asked 
about the initial doses of the diluted one, that's the 
immediate plan. So you have 15.4 million doses.
    We did a preliminary study last spring where we compared 
the undiluted with 1 to 10 with 1 to 100. We found out that the 
1 to 100 dilution didn't work very well, it did not induce a 
very significant take. Let me explain, because I know that the 
question you asked is very relevant.
    This is something that's being tested for safety and take 
rate. And by take rate, we mean to get that characteristic skin 
reaction which traditionally and historically has been highly 
correlated with protection against smallpox infection. We'll 
never be able to do a challenge study because it would be 
unethical and unthinkable to challenge someone with smallpox.
    So we're asking, what is the safety in the diluted 
component, and what is the take rate. On that preliminary 
study, we found that it was about 70 percent take rate. Since 
that we felt was not adequate enough, we redesigned a larger 
study, which is a 650-patient study. The screening has started, 
the vaccinations will start within a few weeks. In that study, 
we compare 1 to 10 with 1 to 5 with undiluted.
    Since we know in the previous study that we got 70 percent 
take rate on the one----
    Mr. Shays. Is this with animals that we're doing this?
    Dr. Fauci. No, this is humans, sir. And this is not a phase 
one study. This is called a phase four study, because it's done 
with an already approved product.
    Mr. Shays. Let me just say this to you, I'm a little uneasy 
given that I'm the chairman here, going over my 5 minutes. But 
I do want this issue, so I'll allow the other members to have 
the same amount of time.
    I just want to separate the old method that's in storage, 
you haven't yet addressed the new one. I don't even want you to 
yet, because that's a longer issue and we'll take it up later.
    Dr. Fauci. Right.
    Mr. Shays. But since you started with the existing stock, 
if you don't have smallpox, an outbreak, how are you really 
able to determine its efficacy? Because you can't afflict 
people with smallpox to see if it works.
    Dr. Fauci. Right. And let me try to explain that.
    As I mentioned just a moment ago, we have a lot of 
historical experience that when you get a take, namely you have 
the characteristic reaction----
    Mr. Shays. Define a take again.
    Dr. Fauci. A take is, if I get a vaccination and I put the 
drop on my shoulder, many of us who were born before 1972, if 
you look on your shoulder, you see a very faint little scar. 
It's a little prickly type scar. What happens is you put a drop 
on your shoulder and you take a typical, classical needle, a 
bifurcated needle, and you put about 15 jabs until there's a 
little bit of blood, in an area about 5 millimeters.
    It's a primary take if you haven't been vaccinated before. 
If it's someone like you or I who have been vaccinated before, 
we would have a secondary take. My daughters would have a 
primary take. What that would mean is that after a period of 
time, you'd have the gradual evolution of what looks like a 
pustule, inflamed, and then a scab, and then ultimately the 
scab falls off.
    We know that is correlated with protection. So even though 
we can't and should not challenge someone, we have 
extraordinary historical information that a take is associated 
with protection.
    So the studies that we're doing, and let me just finish 
briefly what I was saying, that the ones that have just 
recently started, that will be finished by the beginning of the 
year, the end of January, the beginning of February, will 
determine if you compare the undiluted vaccine, which we know 
works, with a 1 to 5 and a 1 to 10. For example, the 1 to 5, 
let's say it gives us a 90 percent take. It's not a 
unreasonable assumption, but we have to do the experiment 
first, before we can give you that information.
    If the one to five gives you a very good take rate, and is 
safe, then you have the potential for over 75 million doses 
available to you. That's the immediate plan. And as you 
mentioned, we can go later on into what the intermediate and 
long term plans are.
    Mr. Shays. Let me just summarize what I believe you 
basically have said in the answer, that there is no intention 
to have a universal vaccination program.
    Dr. Fauci. Correct.
    Secretary Thompson. That's correct.
    Mr. Shays. That could only happen, obviously, if we had new 
production with a new vaccine, which, in my understanding, 
we're moving forward with that. And our other members may get 
to that question.
    But in terms of existing stock, you are basically saying, 
the 12 million that is----
    Dr. Fauci. 15.4.
    Mr. Shays. Well, 12 is in great shape, and then it's 
questionable.
    Dr. Fauci. Sure.
    Mr. Shays. OK. But if we use the 15, that you think 
ultimately that you're going to see a one to five time----
    Secretary Thompson. Five to one.
    Mr. Shays. And this will be FDA approved?
    Dr. Fauci. It is not unreasonable to assume that the one to 
five, but we have to do the study.
    Secretary Thompson. It will be FDA approved.
    Mr. Shays. But you're saying, not that you're ordering them 
to, but that you won't move forward unless it's FDA approved?
    Secretary Thompson. Right.
    Dr. Fauci. The FDA is going to be involved.
    Mr. Shays. I just want to make sure.
    Dr. Fauci. Yes. The FDA will be involved in looking at the 
safety and the take rate. Were there any unusual reactions when 
you diluted it, was there something that was not predictable? 
So there certainly will be FDA involvement. This isn't 
something that we do and just give it.
    Secretary Thompson. If I could just say something really 
quick, we have increased the purchase from Acambis from 40 
million doses to 54. That's the one that has the exclusive 
contract. And they have indicated that they will have that 
delivered to us by next July.
    Mr. Shays. But I don't want to get on the new one yet, just 
because it raises questions about--I'd be here another 20 
minutes. I used at least 10 minutes, and Mr. Kucinich, you have 
10 minutes.
    Mr. Kucinich. Thank you very much, Mr. Chairman.
    Mr. Secretary, I want to explore the connection between 
threat assessment incidents and Government response, if I may. 
First of all, to just put things in perspective here, does the 
administration have any information that the incidents of 
reports of anthrax are more widespread than the incidents that 
we've seen reported at various media outlets and in the Capital 
here?
    Secretary Thompson. Congressman, some of that stuff is 
classified and I don't think we should be discussing it.
    Mr. Kucinich. Well, we need to know. It would be comforting 
for the American people to know, is this a widespread problem 
or is it fairly localized?
    Secretary Thompson. To the best of our knowledge, it is 
what we have seen so far. We have no intel that is saying this 
is going to be a wider spread thing. But we have to be prepared 
for it, Congressman.
    Mr. Kucinich. I understand. But when we're speaking of 
threat assessment, we're speaking of something that at this 
point is localized?
    Secretary Thompson. That is the best of our information at 
this point in time. But we are preparing for something much 
more dramatic.
    Mr. Kucinich. And you're in contact with obviously the FBI 
concerning threat assessments and being able to analyze, so 
that you can prepare accordingly?
    Secretary Thompson. That is correct. There are two paths 
currently going on, the criminal path and the public health 
path. We are responding to the public health path and the FBI 
is doing the criminal investigations in Florida, in New York 
and in Trenton and Washington.
    Mr. Kucinich. But you don't see anything, or do you see 
anything, which would favor a mass stockpiling or prophylactic 
consumption of Cipro or any other drug that's related?
    Secretary Thompson. We feel that to be on the prudent side, 
it is imperative for us to increase the amount of purchase from 
antibiotics that would treat 2 million people for 60 days up to 
12 million people. We feel that it's also advisable, even 
though we have no knowledge or basis at this point in time for 
any kind of smallpox to have 300 million doses of smallpox 
vaccine, just in case it ever did break out, because it's so 
contagious.
    Mr. Kucinich. There's no connection, though, between that 
and a threat assessment?
    Secretary Thompson. No, there is not.
    Mr. Kucinich. This is just you saying, well, you know, what 
if this happens, we have to be prepared.
    Secretary Thompson. Let's be prepared.
    Mr. Kucinich. Let's be prepared, but you don't have any 
information that suggests that there's any kind of a reason for 
the American people to be concerned that suddenly smallpox is 
going to be a reality in their communities.
    Secretary Thompson. That is correct.
    Mr. Kucinich. OK.
    A few weeks ago when the first discussion began to surface 
about anthrax, I remember a report, I think I'm pretty sure 
this is what I heard, that there was a theft of some anthrax 
from a Government lab. Had you heard of that at all?
    Secretary Thompson. We have heard of it. But we have also 
found out that there's a lot of rumors going on, and a lot of 
the rumors we found, we do not know about that.
    Mr. Kucinich. Let's go back to threat assessment and the 
role of Health and Human Services. Are you aware of where any 
biological agents that could be used against people anywhere 
are in the control right now of various Government 
laboratories?
    Secretary Thompson. We are absolutely certain that there 
are biological agents in Government laboratories, because 
they're doing research on them, Congressman.
    Mr. Kucinich. Right. OK. Do you ever talk to the people who 
are doing research on these, on anthrax, on smallpox, on 
botulism or any of these others about the security of that and 
the connection between that security and public health 
concerns?
    Secretary Thompson. I certainly have. In fact, I went down 
to CDC and went through the laboratories down there, and I'll 
be spending a couple of days next week down at CDC, 
Congressman, doing just that. We also looked at the IG report, 
which I had done, to take a look at laboratory security. We 
have increased the laboratory security in all of CDC and NIH 
labs, and we're asking for some more money in this 
appropriation to improve it even more so.
    I am not satisfied, if that's what you're asking, with the 
laboratory security presently. It's much better than it was 3 
months ago, and it will be much better if we get the necessary 
money to do so.
    Mr. Shays. Could we have that report submitted for the 
record?
    Secretary Thompson. Sure.
    Mr. Shays. Thank you.
    Mr. Kucinich. Since we're talking about threat assessment 
here, we should be aware of what the Government itself may 
possess that could create some problems. So I'd also like to 
ask you, Mr. Secretary, you articulated a number of agencies 
you've been in touch with. Have you been in touch with, for 
example, the Department of Defense, relative to any research 
that's going on in the Department of Defense, and the security 
of those defense related matters where they might be looking 
into different types of warfare?
    Secretary Thompson. We have--let me answer in two ways. 
First of all, we have the most virulent viruses in the world in 
our laboratories.
    Mr. Kucinich. That's what I'm concerned about.
    Secretary Thompson. We're the only ones that are really, we 
and the Russians are the only ones that are supposed to have 
smallpox, the smallpox virus. I said we are supposed to.
    Mr. Kucinich. Have there been any discussions about maybe 
destroying these viruses that we have currently within our own 
control, so that they don't get into wrong hands?
    Secretary Thompson. There have been many discussions, but 
while somebody else has the virus, we do not feel that it is 
the proper thing to do to destroy our virus. And in regard to 
the intel, Congressman, we have intel coming in from all 
sources into our room downstairs. I hope you will avail 
yourself to go downstairs and take a look at this after the 
hearing. We have intelligence coming from the Department of 
Defense, from CIA, FBI, on a daily basis, on an hourly basis.
    Mr. Kucinich. I want to go back to something now. You know, 
as some of the wonderful work we do in this committee, we have 
the opportunity to see that sometimes the Department of 
Defense, which does the best job it can, can't account for 
various defense material. It's just so big, it's hard to keep 
track of rocket launchers and boats and airplanes and things 
like that.
    So I want to go back to something you said about the 
biological and chemical agents, which as you said might be some 
of the most powerful, something to that effect, in the world. 
Why, if we have reports that some of this material, anthrax, 
has been spirited away or suspected to be spirited away, or 
reports indicate it has been spirited away from a Government 
lab, in addition to security, why don't we destroy these? 
Unless--we're not certainly intending to use them against some 
civilian population somewhere, I would imagine. I don't believe 
anybody's ever suggested that.
    So why don't we destroy, and why don't you as the 
Secretary, who is concerned about public health, lead the 
effort to destroy any kinds of agents which may exist right now 
within our own country that if they got out of control would be 
like opening Pandora's box?
    Secretary Thompson. We are confident that the smallpox 
virus we have is all there and accounted for on a regular 
basis, and there's none been missing.
    In regard to why----
    Mr. Kucinich. If I may, Mr. Secretary, and I appreciate 
that answer----
    Mr. Shays. Let him answer.
    Mr. Kucinich. Please.
    Secretary Thompson. The reason we haven't is because other 
countries--at least one other country has it. And we need that 
virus in order to do the necessary research, in order to be 
able to build an antibiotic or a vaccine for the mutation that 
may take place in other viruses.
    So if we had destroyed ours, and another country had the 
smallpox virus, they could mutate it and produce a smallpox 
that we could not have a vaccine. Therefore, we need this to 
protect America and protect our citizens, to develop a counter-
balancing vaccine to a mutated virus that may come from a 
foreign country.
    Mr. Kucinich. You said Russia is the other country, is that 
what you said?
    Secretary Thompson. When smallpox was eradicated, there 
were two countries that had a deposit of smallpox virus, the 
USSR at that time and the United States.
    Mr. Shays. Would the gentleman yield just for a second?
    Mr. Kucinich. Sure.
    Mr. Shays. We had testimony before our committee, Mr. 
Alibek for one, who said that North Korea in his judgment has 
it and was experimenting with it. And there is no certainty 
that other institutes and so on that might have had the virus 
destroyed theirs and just left it with the United States and 
Russia. So we have some real uncertainties here.
    Secretary Thompson. We have some uncertainties. We do not 
have conclusive proof that North Korea or Iraq has it. We think 
that there's a 50-50 chance that they do.
    Mr. Kucinich. OK. I'm going to, I thank the chairman, I 
thank the Governor. I just want to say, this might be something 
we might want to get into further discussions about.
    Secretary Thompson. I would like to go into a closed 
session, if you want to get more in detail.
    Mr. Kucinich. Sure. And since we're meeting with Russia and 
talking about a new era of relationship with Russia, this might 
be a good time to take some major steps here.
    Thank you.
    Mr. Shays. Thank you.
    Mr. Lantos, you have 10 minutes.
    Mr. Lantos. Thank you very much, Mr. Chairman.
    Let me commend you for a very fine testimony, Mr. 
Secretary.
    Secretary Thompson. Thank you.
    Mr. Lantos. And let me sort of put my questions and 
comments in some kind of perspective. This country has never 
been more united and more determined, there is no doubt in my 
mind that we shall prevail. We have the capability 
intellectually and the resources materially to prevail. And the 
question we are debating is how we go about it.
    Now, in a $10 trillion economy, which is what we have, no 
one could argue that we do not have the resources to provide 
the American people, all of them, the maximum possible safety 
against all hazards, whether it's bioterrorism, whether it's 
any other type. Yet I find that the people in the public health 
field are extremely critical of the budget proposed by the 
administration. Today's Washington Post has a story, I presume 
there are similar stories across the country, let me ask you to 
react to some of the issues that your critics have raised.
    The administration's proposal, says the executive director 
of the American Public Health Association, in this field of 
fighting bioterrorism, is not adequate. You are proposing $300 
million, the executive director of the American Public Health 
Association says he needs $1 billion. An Ohio health scare 
consultant, public health officer, says antibiotics and vaccine 
without staff and basic infrastructure is like putting Band-
Aids on a huge wound. You can't just rent some people and drop 
them into a department that doesn't have the training or 
technology to handle a biological or chemical attack.
    The dean of the Public Health School at Columbia University 
says, there's a whole bunch of things we need, and this $300 
million doesn't begin to do all of these things. Now, at a time 
when every single poll and every fiber of our common sense 
indicates that safety and security is at the top of the agenda 
of the American people, how do you respond to these charges 
coming from people who have no personal interest in seeing 
these budgets doubled or tripled or quadrupled? These are 
people operating in the non-profit sector, like Columbia 
University's School of Public Health. Serious people who have 
spent a lifetime studying these issues, and they say that the 
administration's approach is woefully inadequate.
    Secretary Thompson. I would say to those individuals, some 
of whom were in the previous administration----
    Mr. Lantos. What does that mean, Mr. Secretary? Does that 
mean that a professional, a physician who was in the previous 
administration has his credentials to be questioned?
    Secretary Thompson. No, no, I'm just saying that the person 
that you first quoted was an individual that was in the 
previous administration, and I don't believe that in the 
previous administration there was enough investment in the 
public health system. And I'm not being critical. I'm just 
stating a fact. I think that a lot of people, including those 
that you mentioned, including people in this Department, 
recognize the importance of strengthening the local and State 
public health system.
    I think you agree, and I agree with you, that we have some 
holes, some weaknesses. Our local and State public health 
system has been stressed. And it's being stretched right now. 
What we need to do is invest in it. And the $300 million is the 
first giant step forward.
    Now, I am still working----
    Mr. Lantos. $300 million, Mr. Secretary, is $1.10 per 
person in this country per year. That's what it is.
    Secretary Thompson. I understand. I do not want to argue 
with you, because I think you and I are on the same page. I 
think we both realize that we need to put more resources into 
our State and public health system. The $300 million is a giant 
step forward from where we have been.
    Does this mean that this is going to cure all evils? 
Absolutely not. Does this mean that we're going to have to 
invest more in the future? Absolutely. If we want a strong, 
coordinated local and State public health system, we're going 
to have to invest in it.
    And as I said yesterday to the same group that's 
criticizing me and that you quoted today, and I said yesterday 
to those individuals, there is a consequence. There's some good 
that came out of the terrorist attack on September 11th. And 
the good consequence of what came out of that is, I think we 
now recognize the importance and the need to invest in our 
local and State public health system.
    This is a huge step forward. Is it enough in the future? 
No. Is it enough for this particular year? I think it's 
adequate. And I think that's what is important for this 
committee to know. It is much more than we've had in the past. 
Do we need more in the future? Absolutely.
    Mr. Lantos. Well, the reference to the future is somewhat 
intriguing, in view of the earlier testimony that we really 
don't know when the next terrorist attack comes. We don't have 
unlimited time to prepare for it. And what your critics are 
saying, Mr. Secretary, with all due respect, is the future is 
now, that this is not a leisurely period in American history. 
September 11th put an end to the age of frivolity and the age 
of seriousness is now with us.
    Secretary Thompson. Yes, it is.
    Mr. Lantos. The age of maturity is now with us. And this 
gradual approach which clearly reflects the way this budget was 
put together, your critics say is not responsive to the crisis 
the American people face.
    Secretary Thompson. I think that my critics are being too 
harsh. This is a huge step forward, and we are investing money 
in the places that they would like us to invest, maybe not as 
much as they would like. And I continue to work with Senators 
Kennedy and Frist and hopefully with you, Congressman Lantos, 
to maybe increase that. But that is something that Congress is 
going to have to make the determination right now, this is the 
administration's proposal, and I am fairly comfortable that if 
you increase that in these areas, I'm certain the President 
will strongly endorse it.
    Mr. Lantos. But Mr. Secretary, could I just ask you an 
economic question?
    Secretary Thompson. Sure.
    Mr. Lantos. An increase of $300 million, which amounts to 
$1.10 per person per year, can that be viewed as a serious way 
of addressing a woefully inadequate public health capability in 
responding to bioterrorism?
    Secretary Thompson. It's not only the $300 million that the 
administration is asking for, it's asking for an additional 
$1.6 billion against for our fight against bioterrorism. So 
it's not just the $300 million. The $300 million is just that 
portion dealing with the local and State health----
    Mr. Lantos. That's right.
    Secretary Thompson [continuing]. On this. But the total 
package, $1.6 billion, which is a lot of money, and it's a lot 
more than we've had in the past. Could we use more? Absolutely. 
But is this a tremendous, legitimate step forward? Absolutely.
    Mr. Lantos. Well, let me just say, if I still have time, 
Mr. Chairman----
    Mr. Shays. About 1 minute.
    Mr. Lantos. I appreciate that. One of the things that this 
horrendous and monstrous event on September 11th did to the 
American economy, it dramatically increased the cost of doing 
business. Just ordinary business. The airlines are putting in 
new cockpit doors. The costs across the whole transportation 
system will be astronomical.
    We have to adjust ourselves psychologically to being 
willing to pay for these things just as during the generations 
of the cold war, the American people were prepared to pay for 
security. Now we will have to learn to pay for domestic 
security, and public health is the front line of domestic 
security. And I very much hope that you and the President will 
be open to significantly increasing these proposed amounts.
    Secretary Thompson. Congressman, I would just like to point 
out that this President and me personally are passionate about 
strengthening the local and State public health system. I flew 
down to Atlanta to give that message yesterday to several 
thousand public health workers. I asked them for their 
cooperation and their input in order to improve it and to make 
it better.
    I applaud you for suggesting that we do that. And hopefully 
we will be able to come up with a bipartisan package that's 
going to continue to move forward to improve the quality and 
the ability to give public health services to every American.
    Mr. Lantos. Well, you have my full commitment, as does the 
President, to improve the public health capabilities of this 
country.
    Secretary Thompson. And you have my dedication, my passion 
to do so, Congressman.
    Mr. Lantos. Thank you. Thank you, Mr. Secretary.
    Mr. Shays. I thank the gentleman.
    Mr. Putnam.
    Mr. Putnam. Thank you, Mr. Chairman, and thank you, 
Secretary Thompson.
    We have heard considerable testimony on this topic over the 
course of a number of hearings. To paraphrase Churchill, we may 
have a woefully inadequate public health system, but I'll take 
ours over all the rest. I have tremendous confidence in your 
abilities and in the administration's commitment to combating 
biological terrorism. All of us are learning a lot as we go 
along. We have had some hints in the past and we have made some 
preparations, but obviously we have much more to do.
    I have every reason to believe that when you and your very 
qualified, very professional, very dedicated team of scientists 
and researchers come up with the magic number per capita, that 
would keep us all safe and give us the maximum possible safety 
from all hazards, that you will share that with us.
    But in the meantime, I would like to followup on some of 
the proposals that you have outlined. You mentioned your desire 
to put one State epidemiologist, to fund them in every capital. 
How many States have the epidemiologists with the credentials 
that you believe are needed?
    Secretary Thompson. Thirty-five.
    Mr. Putnam. So we're well on our way to meeting that goal 
of having one in every State.
    On the health alert network, in this age of rapid 
communication and instant connectability, what are the barriers 
to having an e-mail system or rapid notification system, not 
just every county health department, but to every hospital and 
clinic in the Nation, that on a moment's notice, a message 
could go from Atlanta or from Washington and make these 
hospitals aware? What are the barriers to us having that now?
    Secretary Thompson. The resources in order to make the 
connections, and the equipment in the hospitals and clinics to 
receive that. It's certainly a giant step forward. We have 
approximately 68 percent of the counties connected right now. 
We need to increase that considerably. And we need to make sure 
that the resources are available to hook up hospitals and 
clinics and local health departments with CDC.
    We have ways in order to get the information out right now. 
But it would be nice to be able to be hooked up on the Health 
Alert Network.
    Mr. Putnam. So it is a separate network?
    Secretary Thompson. Yes, it is.
    Mr. Putnam. But to get critical information to hospitals 
and clinics, surely there is a data base of e-mail addresses 
that with several keystrokes you could get critical information 
out?
    Secretary Thompson. Oh, absolutely. We have dial-up 
communication, we have fax and we have e-mails and everything 
like this going in there. But the Health Alert Network is not 
connected to every hospital or every county. And if you want 
the best system, that would be the best for CDC in order to 
communicate quickly and correctly to every health officer in 
America.
    Mr. Putnam. Mr. Kucinich raised some important points about 
laboratory security, and I know that CDC and NIH have taken 
steps. Are there other private sector or academic institutions 
that have access to pathogens or biological weapon potentials 
that need to beef up security and what's being done to address 
those particular situations.
    Secretary Thompson. I don't know about the latter part, but 
they have pathogens and they have some bacteria in the State 
laboratories. We had requested some legislation for this 
Department, for our Department, it's moving through the House 
today to give our Department more authority to regulate the 
private labs, which contain many biological agents that could 
be mobilized, besides smallpox. We are looking for that 
legislation to pass. We know it's got bipartisan support, and 
hopefully it will.
    Mr. Putnam. But absent that legislation, so status quo is 
that----
    Secretary Thompson. We do not have the power. We can 
encourage them to do so, and to beef up their security. And 
they have been wiling to do so. But we don't have the authority 
to go in and direct them to do so, Congressman.
    Mr. Putnam. Do you license those facilities or have any 
kind of a certification, any kind of regulatory oversight at 
all?
    Secretary Thompson. No, we don't.
    Mr. Putnam. That is troubling. I look forward to working on 
you with that legislation.
    Dr. Fauci. Not with regard to the security that you 
referred to, Mr. Putnam, but what has happened over the past 
several years is that prior to 1996, when it was relatively 
easy for academic institutions to get material that might 
ultimately be utilized, if it was used nefariously, to have a 
bioterrorism potential, now is very strictly regulated as a 
select agent. So I'm not addressing your question of security 
once the microbe is in an academic center. But over the last 
several years, it has become much, much more difficult for 
someone to get an access to a microbe without having a strict 
connection regulation with the CDC.
    In other words, there are select agents now that fall into 
that category that you can't just call up and get somebody to 
send something to you.
    Mr. Putnam. We've heard testimony where some people have 
taken their handy dandy computer and printed up a letterhead on 
Acme Laboratories and sent off for microbes, and you're telling 
me that----
    Dr. Fauci. Right now that would not be allowable under a 
law that was passed. And it was stimulated by someone who tried 
to get an agent from the American Type Culture Collection. And 
that now, since I believe 1996--is that right, Scott?
    Dr. Lilibridge. Correct, about that time.
    Dr. Fauci. About 1996. But that doesn't address your 
question, which the Secretary just mentioned is something that 
we need to improve on.
    Mr. Putnam. Is there some kind of information sharing, so 
that local health departments and local health departments and 
local first responders are aware that in the facility in their 
back yard, those microbes are in that community?
    Dr. Fauci. I can't answer that question from my vantage 
point.
    Mr. Putnam. As a farmer, I have to let the fire department 
know when I buy fertilizer, as part of the community right to 
know law. And I know that applies to toxic chemicals. I don't 
think it applies to microbes. Is there a similar law that 
applies to microbes or other pathogens?
    Dr. Lilibridge. No. Not at this time.
    That information is not automatically shared with health 
authorities. It is shared with law enforcement authorities who 
have connections at the local level.
    Mr. Putnam. Thank you.
    We've heard testimony from Mr. Alibek, who's become world 
famous now for his work in anthrax as part of the Soviet 
Union's biological program, and I think everyone's taken great 
interest in some of the horrifying things that he shared with 
us. In his testimony last week, he outlined a strategy for 
broad spectrum and prophylaxis with less emphasis on 
vaccinations. The purpose of this hearing is obviously to talk 
about vaccines, which predominantly addresses the issues of 
anthrax and smallpox.
    But if you follow the method of operation from these 
terrorists who switch on a dime from Embassy bombings to using 
commercial aircraft to blowing up ships in port to using 
anthrax, we have, I think, a reasonable expectation that the 
anthrax will pass soon and there will be a very different 
threat. So to broaden this a little bit, in addition to 
stockpiling the vaccine for smallpox, what are we doing from a 
broad spectrum perspective, akin to what Mr. Lantos was saying, 
to improve our public health surveillance, to improve the 
education of all of our health workers, and what are we doing 
on a broader level beyond just the disease of the day?
    Dr. Lilibridge. Let me mention a few things and then turn 
to Tony Fauci to round up some of the research agenda, looking 
over the horizon. What we've been doing for the past 3 years is 
begin to build public health infrastructure around the issues 
of disease surveillance, laboratory capacity, training, both 
for clinical recognition but for laboratory recognition at the 
State and local level. This has been in effect well before the 
events of September 11th, and has been accelerated to a great 
extent since that time.
    What this allows local practitioners to do, both in the 
public health community and in the medical community, is to 
have early recognition, either through training, seminars, 
collaborations with guilds like the American Hospital 
Association [AMA], the American Public Health Association and 
those kinds of forums, as well as combined Department of 
Defense, HHS educational programming for clinical disease 
recognition to get beyond that disease of the day kind of 
thing.
    It has included a wide range of critical agents for public 
health awareness and continues to accentuate those things that 
are critical to an understanding of the State and local level 
for disease detection and control.
    With that, let me turn to Tony Fauci for a little more 
about the research on the horizon.
    Dr. Fauci. Mr. Putnam, what Alibek was referring to 
specifically was the medical approach of a highly specific 
approach, like a smallpox vaccine, an anthrax vaccine or an 
anthrax drug, that boosts what we call the innate or somewhat 
non-specific immune system. He was referring to research on 
inducing a component of the immune system that only over the 
last few years has come under intensive study. We refer to it 
as the innate immune system. It's innate because it has the 
capability that a first responder. It's an evolutionary 
component of when mankind evolved to protect itself against 
different types of infections. The first line of defense is the 
innate immune system.
    So it has a much broader, non-specific capability of 
attacking a microbe. So the point he was making is that if you 
put your money with smallpox vaccine, this vaccine, that 
vaccine, while you're doing that, he doesn't say don't do that, 
and we totally agree with that, that you should also be pushing 
for something that's more broad. And that gets into the 
category of what the Secretary was referring to as the basic 
research as well as the applied and the research that you can 
use, for example, with a vaccine.
    There is considerable amount of research going on at the 
NIH, specifically in my institute, which is the institute that 
studies the immune system and infections. It is that interface 
between the immune system and infection that I believe over the 
next several years will lead us to a more comprehensive 
approach toward microbes. But that's not something that's going 
to address the question tomorrow or next month. But it's the 
research that's going to give us a greater capability 5, 6, 7, 
8 years from now.
    Mr. Putnam. Thank you very much, Dr. Fauci, and Secretary 
Thompson. You and your people are very much on the front lines 
of this new war, and are patriots for that, and probably under-
recognized for the tremendous responsibility that you bear, and 
we appreciate what you're doing.
    Mr. Shays. I thank the gentleman. Mr. Sanders.
    Mr. Sanders. Thank you, Mr. Chairman.
    And Mr. Secretary, thank you very much for your important 
and informative remarks. This is a serious crisis and you are 
attempting to deal with it seriously. We're just going to have 
to work together and share the ideas that we have as best we 
can.
    I am especially delighted, in response to Mr. Lantos, your 
strong commitment to significantly improve our public health 
systems. I have always believed that it is a national disgrace 
that in the richest country on earth, 44 million Americans have 
no health insurance and many more are inadequately insured. But 
given a health care crisis as a result of a terrorist attack, I 
remain concerned that there are many, many millions of 
Americans who will not know where to turn, that there will not 
be health care facilities in their community that they can 
access.
    Now, during the campaign, President Bush, Candidate Bush 
then talked about federally qualified health centers, which 
seemed to me to be an extraordinarily cost effective mechanism, 
not only to provide health care to all Americans, but to deal 
with this current crisis. I come from a rural State. There are 
people who live 100 miles away from a hospital. They may not 
know who their doctor is. It would be of real value to people 
all over this country to know that there is at least one health 
care clinic in their area that they can walk into, regardless 
of their income, and get care during an emergency, get the 
medicine they need, etc.
    I would hope that in the midst of this crisis, we raise 
again the issue of federally qualified health clinics, and we 
adequately fund them and we set them up in every county in the 
United States.
    Second of all, let me reiterate my concern about the power 
of the drug companies. It is no secret, I think, as you may 
well know, that the pharmaceutical industry is the most 
powerful lobby on Washington. They always win, which means we 
end up paying the highest prices in the world.
    Now, I understand that Bayer has indicated to you that it 
will take 20 months to produce all the Cipro that you have 
requested. Yet the FDA has tentatively approved five generic 
manufacturers to make Cipro. And they have indicated that it 
will take 3 months to produce the same amount. And I wonder if, 
in a moment, you can comment on that, why we would not go with 
five companies who produce what we need in 3 months rather than 
Bayer in 20 months.
    The last question that I wanted to ask is the following. I 
think as we have all indicated, nobody here is happy about 
raising nightmarish situations, but it is important that we do, 
that we get it out on the table and we do our best to be able 
to respond. Let me throw a nightmare at you.
    I am concerned, and I hope that you people can tell me that 
my concerns are not justified, I fear very much the possibility 
that on some windy Saturday morning, a half a dozen small 
Cessnas will take off in different locations in this country, 
each with a couple hundred pounds of anthrax, and that 
simultaneously they will be released. And if that is the case, 
it would mean, given the weather and the temperature and the 
wind, that tens of millions of people could be exposed to 
anthrax.
    Now, my question is, go through that scenario and tell us 
our capabilities in responding for a stock, as I understand it. 
The good news is that if we know we are exposed to anthrax, we 
can treat it with antibiotics. That's very important and very 
good. How will you, will the U.S. Government, will our local 
public health authorities be able to tell the American people 
before they develop the symptoms, guess what, we've got a 
crisis, get to the hospital, get your medicine right away? Do 
we have that capability to detect anthrax in the air? Do we 
have--you asked for 12 million doses, as I understand, for 
Cipro. Maybe you could tell us why 12 million and why not 100 
million and so forth and so on.
    But I fear, I appreciate that's a nightmarish situation. 
But all over this country, every health resource is strained to 
the utmost degree. Can we and are we moving to try to deal with 
that scenario, understanding that the good news is, if we have 
our act together, that we can perhaps minimize the death and 
suffering that might take place? Because as you have indicated, 
anthrax is treatable if we get to it soon enough.
    So those are my--I wanted a specific response, if you 
could, about Bayer and 20 months as opposed to the other 
companies, federally qualified health clinics and this 
nightmarish scenario.
    Secretary Thompson. Thank you very much, Congressman 
Sanders. Let me try and go through many of the things you've 
said, and then Scott Lilibridge will want to respond and I'm 
sure Tony Fauci will as well, to your nightmarish thing that 
hopefully will not happen.
    First off, in regards to community health centers, 
federally qualified centers, as you know, the President put in 
his proposal enough money to increase that from 2,200 to 3,400, 
an additional 1,200, and go from 11 million people to 20 
million. In regards to every county, I am not opposed to that. 
As you can probably recognize, I think that is a way to deliver 
good quality health care in America. And also, coming from a 
rural area, I know the importance of community health centers 
and federally qualified health centers. So I recognize that. 
Whether or not the resources are there, whether or not Congress 
is going to pass it, I don't know.
    Mr. Sanders. But you recognize this is a very cost 
effective way to provide quality care?
    Secretary Thompson. It's one of the best. And I think it 
is, I think they get very good quality health care there. I 
have spoken to them, been involved and raised some money for 
them personally and been very much involved. It's a very cost 
effective way.
    Mr. Sanders. And they could play a role, if, God forbid, we 
need them.
    Secretary Thompson. They could. Second, I want to point out 
that once again, how do we notify people? What we do is we have 
7,000 medical professionals throughout the United States 
divided into 90 teams. So we would move very quickly. We have 
CDC sending out epidemiologists and we would also have NIH, we 
also have our Commission Corps, if it was a vast thing. We 
would be able to call those people up within hours.
    Mr. Sanders. Yes, Mr. Secretary, here was my question, 
though. Can one detect anthrax in the air before one develops 
the symptoms? In other words----
    Secretary Thompson. No.
    Mr. Sanders [continuing]. The problem would be that if it 
takes you 3 days, by the time you've got a symptom, you've got 
a problem.
    Secretary Thompson. We haven't been able to determine that.
    Mr. Sanders. Are we working on trying to develop a 
mechanism?
    Secretary Thompson. Yes, we are. But we haven't found it 
yet. But the third thing is that, in regard to Bayer, that you 
are concerned about, I'm not here to defend Bayer. I'm here to 
tell you that we're negotiating with them, and once 
negotiations are done, I would like to sit down and show you 
what we are. They have indicated to me that they can provide 
200 million pills within 90 days and they can adequately wrap 
up and produce it within weeks, whatever we need.
    But the price is the question, not the supply. And that is 
something we're going to be negotiating and debating. I can 
assure you that we are not going to pay the price that they 
ask.
    Mr. Sanders. Let me ask, am I incorrect in saying that they 
have told you that it would take them 20 months to produce all 
the Cipro you have requested?
    Secretary Thompson. I think you're wrong, because they told 
me they could produce 200 million pills within the next 60 
days.
    Mr. Sanders. And if you are unhappy with their performance 
either in terms of speed of delivery or in price, are you 
prepared to go to generic companies?
    Secretary Thompson. I am prepared to ask Congress for that 
authority.
    Mr. Sanders. Do you know the Canadians have done that?
    Secretary Thompson. I know, but I know that we have a 
different law than the Canadians.
    Mr. Sanders. But you are prepared, if Bayer does not 
cooperate with you, to do that?
    Secretary Thompson. Yes, I am.
    Now, the third thing, in regard to your nightmare thing, 
let's hope it doesn't happen. But I think Scott Lilibridge is 
better able to deal with that.
    Dr. Lilibridge. Sir, let me make a few comments. First, as 
we've gone to this new kind of war, we've developed a game 
plan. We developed this game plan as we refined it over the 
last couple of weeks. And let me just tell you what's emerging 
in this.
    While we had a basic public health commitment to build 
infrastructure in certain areas, we've been on that for the 
past 3 years, we've also been readying our clinical response. 
Let me tell you some of the key elements of this game plan. 
There are clearly preventions, and we are networking with the 
intelligence community to try to interdict, understand, get 
early warning about such events. We do that on a daily basis.
    Mr. Sanders. Do you get early warning in other ways than 
somebody just suddenly seeing a rash of illness in a given 
community and saying, we've got a problem? Can you get early 
warning in other ways before that?
    Dr. Lilibridge. You can. You can get early warning in terms 
of helping you gauge your likelihood of one, prioritize your 
efforts in one pathogen versus another, you can get early 
warning in terms of where to put your resources, and you can 
get early warning to put your detection out and look in certain 
areas.
    We are working with the intelligence, law enforcement 
communities on a daily basis and coordinating in a way we 
haven't done before.
    The second part of the game plan is clearly detection, 
early detection. That involves clinical awareness, picking up 
cases, sentinel networks for surveillance, laboratory kinds of 
information. The third area of the control is disease control. 
That involves the steps to corral and contain the disease, keep 
it from spreading in the population, interdicting steps like 
prophylaxis.
    Mr. Sanders. Would you agree with the Secretary that at 
this point, there is no way of doing air detection and knowing 
if there's something in the air?
    Dr. Lilibridge. Sir, currently, my understanding is that 
real time technology to detect aerosol assault is not 
available.
    Mr. Sanders. Is that something we're working on?
    Dr. Lilibridge. It is something multiple agencies and 
departments are working on in a collective fashion.
    Dr. Fauci. What I can address, sir, is the research 
component of it. What we can do in the future for having 
capabilities of detecting. There obviously are molecular means 
that are research tools right now. You can detect a microbe by 
using what we call a microchip that might be able to determine 
if there's a certain concentration in the atmosphere. That's in 
the research phase right now. That is not going to help 
tomorrow or the next day.
    From the standpoint of research related to better ways of 
addressing anthrax, I think it's important to bring out, the 
public health components of it as Scott mentioned very well. I 
can't add to that. The research that's going on right now is 
trying to address much more specific ways to combat the anthrax 
microbe over and above the question of antibiotics. In fact, 
today, this afternoon there will be a press conference downtown 
by the the Journal Nature talking about some very exciting new 
research about really being able to specifically block the 
toxins of anthrax. I think that's something that we should pay 
attention to. Because we're going to try and translate that 
from the fundamental basic research to something we can try in 
humans very rapidly.
    Mr. Sanders. I think my time has run out. Thank you.
    Mr. Shays. Mr. Secretary, this is probably the only time 
you'll appear before our committee this term. If you don't 
mind, we'd like to do one last pass, and then you can walk 
across the hall to your office. [Laughter.]
    Mr. Kucinich.
    Mr. Kucinich. Thank you very much.
    We heard from the media, the public, Government as they 
interact throughout this----
    Secretary Thompson. Excuse me, can I just interrupt? 
Senators Kennedy and Frist are over here to meet with Dr. 
Fauci. Do you mind if we--do you have another question for Dr. 
Fauci?
    Mr. Shays. I will tell you that I do want to get into the 
whole issue of new vaccines and to what extent do we push FDA 
and so on. But I'm not inclined to have you keep Senators 
waiting. So we'll try to wrestle throughout with Dr. Fauci.
    Secretary Thompson. I have somebody from FDA here.
    Mr. Shays. OK. I'll need to swear them in, but that's OK, 
that's fine.
    Dr. Fauci. Thank you very much, sir.
    Mr. Shays. Would you let the Senators know we were eager to 
have you meet with them? [Laughter.]
    Dr. Fauci. I will convey that message.
    Mr. Shays. Could I ask you to stand and just identify 
yourself?
    Dr. Egen. Dr. William Egen, Deputy Director, Office of 
Vaccines, FDA.
    Mr. Shays. Thank you. Will you raise your right hand?
    [Witness sworn.]
    Mr. Shays. Thank you very much. Nice to have your 
participation.
    The gentleman can start over.
    Mr. Kucinich. I thank the Chair.
    In the last few weeks, we've seen from Government, the 
media, the public, people are experiencing and articulating 
some of their deepest fears. And for that reason, it's a very 
challenging time in the life of our Nation. And with many 
people, when you start to experience your deepest fears, you go 
into a survival mode. And I would just like to suggest that 
such a condition, which has its analog in science and in terms 
of a general stimulus response, is not necessarily conducive to 
maintaining a democracy.
    And that is that we need to meet these challenges as they 
arise and try to prevent them as best we can. We need to take 
great care that as we explore these various public health 
challenges that could come up, that we do not create hysteria 
or induce a panic among the American people. Because panic is 
not a good place from which to make decisions.
    Now, I think we're starting to redefine what are public 
health issues here. I'm certain the Secretary has come up with 
some new definitions of public health since September 11th. And 
one of the things that occurs to me, with this dialog we had a 
few moments ago about biological weapons that may be present on 
our own shores, with the Government, with the private sector in 
some way, that for the first time, the biological weapons 
treaty becomes a public health issue. Because if we can find a 
way to start to control biological and chemical weapons, it's 
quite possible that such weapons will not be used against mass 
publics, therefore occasioning the kinds of concerns which HHS 
is very busy about these days.
    So I wanted to share that view with you, Mr. Secretary, 
because I know that based on your interview with 60 Minutes 
that, and based on your experience as a Governor, you try to 
maintain a confident outlook, you try to communicate to the 
public that we're going to do everything we can to protect 
them, you're also aware of all the different variables.
    Secretary Thompson. That's right.
    Mr. Kucinich. And I think that you're trying to do the best 
job you can, and I respect that and I appreciate your service. 
Now, one of the things that we need to look at, I believe, is 
to focus resources more and more on the National Medical 
Response System, which is intended, as you know, to help every 
city, locality or metropolitan area design a disaster plan for 
public health emergencies. Now, it's operated through contracts 
awarded through HHS and FEMA has estimated that it would cost 
approximately $2.5 million per city to develop and coordinate 
these plans.
    And actually, those kinds of plans make sense. It gets 
people working together in the event of any contingency. So 
there is a sense through that work, people gain a sense of 
security that we're ready, we're prepared. And then they can go 
about their life a little bit easier.
    Now, currently, according to my information, HHS has been 
giving about $600,000 to each city. And your new proposal 
provides only $50 million more for local and State plans. 
According to my calculations, this would be enough to only 
bring about 25 cities up to the minimum level recommended by 
FEMA. And of course, there are more than 25 cities that need 
full funding for public health emergencies.
    What can you do as the Secretary to help local communities 
get the resources to prepare for public health emergencies and 
begin the process of trying to bring some peace of mind to 
communities that at least are working to deal with 
eventualities whether or not they in fact ever materialize?
    Secretary Thompson. Several things. First, I can use the 
bully pulpit of my office. Second, we are expanding it from 97 
to 122 cities, as you've indicated, 25. It's important. I think 
that stretches us to about, with everything else going on, I 
think that's about as much as we can handle in this particular 
year, Congressman. It would have been nice if we could do more, 
but we want to, what we do we want to do correctly and be able 
to develop the best systems, the best plans.
    No. 3, I am trying to be confident in outlook, because I 
think it's very important for the American people to know that 
we are not going to allow the terrorists to defeat us through 
terror. We've feared the bio, but the second part of that, the 
terror, is what you talked about, and it's important.
    Fourth, we do need the supplemental plan approved by 
Congress. It's important for us to get those extra dollars into 
the local and State public health systems. If Congressman 
Lantos is successful in getting more, we will be able to put 
that to good use. I think it is important for all of us to 
realize that this is a bipartisan thing. I think that in the 
past, I don't think we've invested in our public health system 
very adequately. And I think we've actually disinvested.
    I think it's important for us to realize that and now move 
forward on a bipartisan basis to strengthen and coordinate our 
local and public health systems, develop disaster plans, 
develop educations, put epidemiologists in our health 
departments wherever we possibly can, expand our Health Alert 
Network and be able to get that kind of education and 
information to our local health departments, our hospitals, as 
well as educating our emergency ward people, our doctors and 
nurses, how to diagnose and how to look at things. Because 
they've been trained in medical school, but since they've never 
seen anthrax poisoning, they probably could miss it.
    So it's important for us to do all of these things in a 
cooperative and collaborative fashion, through the Department 
of Health and Human Services, NIH and CDC and with Congress.
    Mr. Kucinich. Well, I'm glad to see the Secretary 
articulating, it's brought a vision of involvement of HHS 
working cooperative with government at all levels to try to 
make sure that our public health institutions will be up to the 
challenge. Not only the challenge that we find as a result of 
the events of September 11th, Mr. Secretary, there are, Mr. 
Sanders alluded to it earlier, there are 43 million Americans 
right now who don't have adequate health coverage. It may be 
with insurance companies bringing a parade to Congress looking 
for bailouts of their very industry, which is supposed to be 
about risk, that we may find your department achieving a larger 
and larger role in the functioning of public health in this 
country, even beyond what you do.
    Secretary Thompson. I never expected when I came out here 
to become an expert in embryonic stem cells and bioterrorism. 
So I would like to get back to public health. [Laughter.]
    And I never expected to have to the Capitol under an 
anthrax scare, and I'll tell you, we'll never do it again.
    Now, I want to conclude with this discussion, again, that 
Mr. Sanders started. This is about this generic manufacturer of 
Cipro. It's possible, since you have five generic companies 
that have already tentatively been approved to manufacture 
Cipro, and it's legal, because the Government has, as you know, 
both the authority and the precedent to act under the TRPPS 
Agreement, Article 73, security exceptions clause, ``nothing 
construed to prevent a member from taking any action which it 
considers necessary for the protection of its essential 
national security interest, taken in time of war or other 
emergency in international relations.''
    So we have a legal precedent there. We also have 28 U.S.C. 
Section 1498, which allows the Government to purchase products 
for official use from alternative sources, with payment to 
patent holder of a royalty fee to be determined by a judge. And 
I might say, as Mr. Sanders has repeatedly stressed, it's 
cheaper, for the U.S. Government, the purchase price is nearly 
$2 per pill, generic versions are 20 cents or less per pill. 
That means with $643 million, of the $1.5 billion HHS 
requested, the United States could buy enough generic doses to 
treat 31.5 million people instead of merely 2.6 million people, 
if we were paying top dollar.
    So these are considerations, I'm sure, that you're going 
into because you want to make sure that you can, if we need to 
deal with this, or if we have it stockpiled, at least to have 
the ability to respond to help more and more people. I'm 
confident, Mr. Secretary, that these are things you're 
considering.
    Secretary Thompson. You're absolutely correct.
    Mr. Kucinich. Do you feel that you'll be able to look at 
trying to lower the cost to the Government for these?
    Secretary Thompson. You don't know me that well, but I 
negotiate very tough and well.
    Mr. Kucinich. I'll accept that. Thank you.
    Mr. Shays. I just again want to thank the Secretary for 
participating here. We have allocated 10 minutes to each of the 
Members. For the remaining time we've been joined by Mr. 
Tierney as well.
    I just would say to the Members that they don't need to use 
the 10 minutes. We do have three other panels that will follow.
    But at this time we're going to go to Mr. Lantos, then 
we're going to go to my colleague, the ranking member, then to 
Mr. Sanders, then Mr. Tierney, and then I'll finish up.
    Mr. Lantos. Mr. Chairman, I'd like to ask unanimous consent 
to place in the record that brilliant article on germ bank 
security which appeared in today's New York Times.
    Mr. Shays. Without objection, so ordered.
    Mr. Sanders. I'd like to raise some questions.
    Mr. Shays. What date is that?
    Mr. Sanders. Today's. The president elect of the American 
Society of Microbiology estimates that there are about 250 
scientific centers in the United States that have anthrax 
stocks and about 1,000 sites abroad. And clearly, security at 
many if not most of these is singularly inadequate. And 
obviously, determined terrorists are fully capable of obtaining 
anthrax at all of these facilities.
    As a matter of fact, they don't even have to be terrorists 
engaging in criminal acts. Let me remind all of us that a 
fellow by the name of Larry Harris, with a history of 
affiliations with hate groups, managed to buy plague bacteria 
from an American germ bank by mail, paying $100 each for three 
vials. And after he was caught, Congress rewrote the Nation's 
terrorism laws and tightened germ security, imposing tough 
rules on the acquisition and transfer.
    But we have had very little success in having overseas 
facilities follow the procedures that need to be followed in 
this country. I would be grateful if the Secretary or either of 
your colleagues would comment on what steps we are taking to 
see to it that globally this does not happen in the future.
    Secretary Thompson. We haven't done enough, Congressman, 
but I'm going to defer the answer to the question to Scott 
Lilibridge.
    Dr. Lilibridge. Thanks. Sir, there's a number of things 
that we're doing. We have ongoing collaborations 
internationally with groups like the World Health Organization 
that include issues like laboratory safety, training, global 
surveillance and other things that can provide early detection. 
It falls short of interdiction in terms of legal ability to 
detain, acquire.
    But there is a growing international movement, the WHO 
director was at CDC just yesterday, and there is growing 
concern in international circles, both in ministries of health, 
which have been contacting us, as well as WHO, that 
bioterrorism preparedness needs to be a regular part of 
ministry of health activity, and that it needs to be a 
substantial component of the infectious disease control effort 
at WHO. We're going to participate in those efforts.
    Mr. Lantos. I realize, Mr. Secretary, that this is not in 
your bailiwick, but in Colin Powell's bailiwick, but I would 
like to ask you to join me in discussing with Secretary Powell 
that we direct all of our Ambassadors in every country where we 
have diplomatic relations that this issue be raised with the 
appropriate authorities at the highest levels. Because you can 
have the most incredible security here in this country, if this 
security is not present elsewhere, we will face the problem. 
And I would be grateful for your help and cooperation on this.
    Secretary Thompson. That's a very valid suggestion and I 
would enjoy joining with you in that discussion. I think it's a 
discussion that should be taken, Congressman.
    Mr. Lantos. Thank you very much. Before I yield my time, 
let me just say, Mr. Secretary, you have done an outstanding 
job here, and we all appreciate your commitment to this issue.
    Secretary Thompson. Thank you very much, Congressman.
    Mr. Lantos. I yield back.
    Mr. Shays. I thank the gentleman for yielding back. We'll 
go to Mr. Putnam.
    Mr. Putnam. Thank you, Mr. Chairman.
    I want to change gears just slightly. As part of your 
request for supplemental, you have asked for 410 new FDA 
inspectors to deal with food safety issues. Would that be at 
the retail level only, the finished product, grocery store 
level? What is being done to coordinate with USDA to deal with 
agriterrorism and bulk goods?
    Secretary Thompson. We are coordinating very effectively 
with agriculture. But the problem we have, Congressman, is that 
we have 750 agents in FDA. We have 56,000 establishments that 
we're supposed to inspect. And we are inspecting them, we're 
supposed to inspect them once a year. And those who have not 
caused problems we'll inspect maybe once every 4 years, once 
every 5 years.
    There are 132 ports of entry into the United States that 
food is imported into the United States. And we at the present 
time only have 150 agents that are inspecting the food that 
comes in from 132 different ports. We are not even scratching 
the surface as far as monitoring and inspecting foods. The 410, 
200 goes to the border and goes to airports to buttress the 
150, so we would have 350. The other 100 would go to the 
laboratories to give the background checks and to be able to 
improve what we have as our OASIS system. And the remaining 100 
would go to help improve the inspections on the 56,000 sites.
    So FDA has not, FDA is like the public health system, it 
has not been able to get the resources in food inspection like 
we have not invested in our public health system in America.
    Mr. Putnam. Well, you have APHIS under USDA at the ports, 
looking for invasive, exotic pests, plants and diseases.
    Secretary Thompson. That is correct.
    Mr. Putnam. How does FDA overlap with that, if it is a bulk 
container of a perishable fruit or vegetable, is that USDA, but 
if it's meat, is it FDA? Where are the jurisdictional lines 
there?
    Secretary Thompson. They're pretty cloudy. There's really 
no rational reason for it. Agriculture is supposed to inspect 
the beef and poultry and we are supposed to inspect the 
manufactured goods. But in the case of eggs, we inspect the raw 
eggs and they inspect the manufactured eggs, which makes no 
sense whatsoever. And there needs to be further cooperation and 
collaboration with the Department of Agriculture.
    I think that we're working in that regard. Am I satisfied? 
No. Am I satisfied with the inspection we're doing? No. Is this 
going to help? Tremendously. And we have to do a much better 
job. I am more fearful about this than anything else.
    Mr. Putnam. Well, I am, too, and I have been talking about 
this in a variety of committees on the ag side and on this 
side, and even in the legislature, trying to beef up our 
airport and seaport inspection teams. But FDA only deals with 
the finished, processed food product, is that an accurate 
statement?
    Secretary Thompson. That's correct. Yes.
    Mr. Putnam. So all of the raw goods coming in, including 
meat, is USDA's responsibility, not yours?
    Secretary Thompson. That is correct.
    Mr. Putnam. And they have the same inadequate system as 
you?
    Secretary Thompson. Agriculture, I believe, is down to nine 
ports. We have 132 ports of entry.
    Mr. Putnam. Food only comes into--I don't understand.
    Secretary Thompson. Agriculture, the ports that agriculture 
comes in I think are down to nine.
    Mr. Putnam. That sounds a little low.
    Secretary Thompson. I think it's only nine that they come 
in.
    Mr. Putnam. That is an area of great concern. We have 
highlighted, in the frivolous, as we've heard earlier, in the 
frivolous pre-September 11th days we were dealing with things 
like hoof and mouth disease, which would have a huge impact on 
food safety----
    Secretary Thompson. Tremendous.
    Mr. Putnam [continuing]. And food safety in the level of 
quality and healthfulness of our food supply.
    Mr. Shays. Would the gentleman yield a second? Given that 
you have staff here, if they could confirm that so we could put 
it on the record as to how many points of entry.
    Secretary Thompson. I'll get that for you.
    Mr. Shays. Before we adjourn, before the Secretary leaves, 
if someone could find that out.
    Secretary Thompson. We'll get that from FDA and also get it 
from Agriculture.
    Mr. Putnam. So we have these other things that were out 
there prior to September 11th that we used to think were scary.
    Secretary Thompson. Like mad cow disease.
    Mr. Putnam. Mad cow, hoof and mouth and all those things 
can be harnessed and weaponized or contained and channeled into 
a particular direction. We have testimony again from Mr. Alibek 
that indicates that he had as many people working on 
agricultural terrorism threats to the economy and livestock and 
crops as he did working on threats to the humans, the 
casualties. So this is of great concern to me, and I hope that 
the coordination will improve between the agencies.
    Secretary Thompson. You know what we should do? We should 
be able to allow agriculture inspectors to be able to inspect 
our stuff and we should be able to inspect agriculture. We 
should have cross-certification. I mean, it's a radical idea, 
but it makes common sense to me. Instead of having two 
inspectors go in the same building, one inspector should be 
able to do it and maximize the time and effort. And it hasn't 
been able to have been worked out, and I hope with this kind of 
a problem, that's one positive thing that may come out of this.
    Mr. Putnam. No question about it, jurisdictional fights. 
And it's not just between FDA and USDA. Because you have Fish 
and Wildlife, you have Customs, you have Border Patrol. And all 
these things didn't have the momentum behind them to be 
seriously addressed by the Congress until September 11th.
    I would hope that all of us will harness this new momentum 
to bring about the radical change that will be necessary to 
establish a safety net at our airports and seaports that we 
just haven't had in the past. There is no cross-training, there 
is very little communication. And even with the best of 
coordination, we're still only hitting a tiny fraction of the 
containers that are coming into these seaports.
    Secretary Thompson. You're absolutely correct, and 
Congressman Putnam, I'm so happy you brought it up. This has 
been a concern of mine for a long time, and I'm so appreciative 
that people like you are concerned about it. I hope that you 
will take a look at our proposal dealing with food safety. It 
is still not enough, but it is a tremendous step in the right 
direction and I would hope that we would be able to get it 
passed in this session of Congress.
    Mr. Putnam. Thank you, Mr. Secretary.
    Mr. Chairman, I yield back.
    Mr. Shays. I thank the gentleman for yielding back.
    Mr. Sanders, and then Mr. Tierney, we'll go to you.
    Mr. Sanders. Thank you, Mr. Chairman.
    Mr. Secretary, I would like you, if you would be so kind, 
to comment on an article that appeared in the New York Times 
October 18, 2001. Let me quote from parts of the article.
    ``Although Bayer, a German pharmaceutical company, is 
tripling production of Cipro, it will take the company 20 
months working 24 hours a day to produce what Mr. Thompson says 
the Government needs, enough pills to treat 12 million people 
for 60 days. The Government currently has enough Cipro for 2 
million people. Five drug companies that have received initial 
approval to make generic Cipro pending the expiration of 
Bayer's patent in 2003 say they could produce the same quantity 
in 3 months--not 20 months, 3 months. One official close to the 
Administration's negotiations with Mr. Shumer said that the 
White House had `clearly made a political decision.' White 
House officials did not respond to requests for comment on the 
issue,'' which is why I'm going to give you the opportunity 
now.
    ``Mr. Thompson acknowledged that there were other 
considerations. `We haven't been in the process of breaking 
patents,' he said today. Bush Administration officials and 
other Republican administrations have long been philosophically 
opposed to meddling in the private marketplace. President Bush 
also has close ties to the pharmaceutical industry, which 
contributed heavily to his Presidential campaign and Republican 
election committees. Two of the President's Cabinet members are 
former drug company executives,'' etc.
    So bottom line here is, it seems that if we went to other 
companies, we might likely have more Cipro quicker and perhaps 
at a lower price. So I would like for you to tell me and the 
American people why we are not moving in that direction and 
also, the issue about treating 12 million people for 60 days. 
God forbid there is a real tragedy, we may need more of that. 
So can you please respond to that article.
    Secretary Thompson. I'll try and respond, Congressman, to 
your satisfaction. First off, it is my understanding directly 
talking to the company that they can produce the number of 
pills that we need in regard to this anthrax outbreak within 60 
days, not 20 months. That's what they have told me as recently 
as of last week.
    Mr. Sanders. So the New York Times said 20 months and you 
believe it is 2 months?
    Secretary Thompson. That is what the company has responded 
to me when I raised that question to them.
    Mr. Sanders. Would you be so kind as to confirm that later 
on, after you talk to Bayer, with this committee, and see if 
the New York Times is accurate?
    Secretary Thompson. Sure. I'm going to be negotiating with 
Bayer this afternoon, Congressman, and that's one of the 
questions that's on my itinerary that I'm going to be talking 
about, OK?
    Second, in regard to the patent issue, I have indicated to 
Bayer that they'd better sharpen their pencil very sharp before 
they come down here, and if they don't sharpen the pencil, they 
don't need to come. Third, if I can get the same price or 
similar price or save the taxpayer dollars, considerable 
dollars, and not break the patent, I see no problem with that.
    Fourth, my lawyers tell me, unless Congress changes the law 
further, that we would have to pay damages to them if they 
brought a lawsuit against us. And that is, I know you're 
smiling, but----
    Mr. Sanders. I'm not smiling----
    Secretary Thompson. Well, that's what my lawyers say, 
Congressman, and I have to rely----
    Mr. Sanders. Well, Mr. Kucinich--if I may----
    Secretary Thompson. Sure.
    Mr. Sanders. Mr. Kucinich raised this issue a moment ago. 
Common sense dictates and international law dictates that when 
you have a national crisis, we do not have to give enormously 
profitable pharmaceutical companies the price they want. That's 
why we're here, to protect the American people. And if they 
want profits rather than serving the people, I think the law is 
very clear that we have a right to go outside of their company. 
Do you disagree with that?
    Secretary Thompson. I do not disagree. In fact, I agreed 
with you earlier. I also told you that, wait until I get done 
negotiating, then I'll sit down and we will discuss whether or 
not I made a good deal.
    Mr. Sanders. But you are not at this point ruling out----
    Secretary Thompson. I am not ruling out----
    Mr. Sanders [continuing]. Going outside Bayer and getting 
it generic?
    Secretary Thompson. I answered Congressman Kucinich that if 
in fact I could not reach an agreement that was advantageous to 
the American public, I would come and talk to this committee 
and to Congress and ask for more authority to do so. And 
knowing your passion for this, you'll be the first one I'd come 
to see and ask you to support the legislation.
    Mr. Sanders. I think, Mr. Secretary, this is an enormously 
important issue.
    Secretary Thompson. It is.
    Mr. Sanders. In this sense, also. It's not only a moral 
issue, but it is very clearly a health response issue. The 
American people would be very disappointed if they believed 
that an industry which has spent hundreds of millions of 
dollars on campaign contributions and lobbying, all that stuff, 
was able to prevail upon the Congress or the administration in 
reaching a decision that only works for the company and not the 
American people.
    Secretary Thompson. And I agree with that. Could I finish 
my answer?
    Mr. Sanders. Please.
    Secretary Thompson. Also, everybody, Congressman, Senators, 
is just concerned about Cipro. But of all the anthrax that 
we've tested, and I want to make this crystal clear, the 
anthrax that's been tested, all of the anthrax that's been 
tested is sensitive to all the antibiotics, Ciprofloxin, 
penicillin, Doxycycline and several other ones. And those are 
generic drugs.
    We think that since they can treat anthrax just as 
effectively as Cipro, and that's what CDC has indicated and FDA 
has approved that, we should start talking more not just about 
Cipro but talk about penicillin and talk about Doxycycline. 
Some of them in some cases are more effective. Some individuals 
have reactions to Ciprofloxin. Some mothers that are pregnant 
should not be taking Ciprofloxin. So we put them on other 
antibiotics.
    And what we're saying is, not only are we purchasing Cipro, 
we are purchasing other antibiotics, such as penicillin and 
Doxycycline to treat anthrax. It is not only Cipro. And those 
are generic drugs and those are going to be purchased.
    I would like to leave this committee and the American 
public with the understanding and knowledge that they can also 
purchase penicillin and Doxycycline if they need to in order to 
prevent and to be able to prevent the infection from taking 
place, if they encounter anthrax. They should not go out and 
hoard it, that's what I'm saying.
    Mr. Sanders. Mr. Secretary, last question on this subject. 
I have heard differently than what you have just indicated, 
that while it is true that penicillin and other antibiotics can 
work effectively, that the product of choice would be Cipro.
    Secretary Thompson. For the first 5 days.
    Mr. Sanders. OK. That is your understanding?
    Secretary Thompson. Correct.
    Mr. Sanders. So if, God forbid, there was an emergency, we 
would turn to that particular drug, Cipro. And then the 
question is, how do we get that product inexpensively, how do 
we produce it? You didn't also yet tell me what's holy about 
the word 12 million, 12 million people rather than more.
    Secretary Thompson. Because it's not contagious, we felt 
that 12 million is an ample supply, if in fact the nightmarish 
thing that you mentioned would come about. We thought that we 
could treat it.
    Mr. Sanders. Let me just ask you again, this is a God 
forbid scenario----
    Secretary Thompson. And we didn't pull this figure out of 
the air, I want you to know, Congressman. This is a scientific 
panel that reviewed this and made this recommendation to me.
    Mr. Sanders. All right. If an aerosol was dropped on our 
three largest cities, you would have more than 12 million 
people. Wouldn't all of those people want to go----
    Secretary Thompson. We also have the 12 million for 60 days 
and we would go back into the market and purchase more during 
the 60 days.
    Mr. Sanders. Thank you very much.
    Mr. Shays. I thank the gentleman.
    Mr. Tierney, thank you for your patience.
    Mr. Tierney. Thank you.
    I've only got two or three questions, following up on my 
colleague, Mr. Sanders' on Cipro, there are press accounts that 
Cipro struck a deal with one of the generic manufacturers, and 
basically received millions of dollars from that generic 
manufacturer to not go into competition on that. What are your 
feelings about that specifically?
    I also understand the FTC may be bringing action against 
them for an antitrust violation. But what are your specific 
feelings about that incident, but also on a broader scale, what 
ought we do to do about that in terms of the whole marketplace?
    Secretary Thompson. I really have no knowledge of that 
lawsuit. I've heard about it, I have not investigated it 
myself, Representative Tierney. And I will, now what you've 
mentioned it, but I haven't had time to delve into it.
    I do know that those individuals want to come and talk to 
me about that lawsuit, and I intend to do so. But at this point 
in time, I do not have the background information in order for 
me to properly respond to your question.
    Mr. Tierney. During the first Bush administration, Mr. 
Bush, Sr., there was a public health representative on the 
National Security Council. My understanding is that President 
Bush stopped that practice. What's your recommendation with 
regard to that? Do you favor having a public health 
representative on the National Security Council?
    Secretary Thompson. Yes. But I have not been asked about 
it.
    Mr. Tierney. You've not even been asked? Let me say, we had 
an occasion over the last weekend to meet with most of the 
first responders in the District, police officers, 
firefighters, EMTs, public health people. One of the major 
topics that they had was communication, in terms of getting the 
message from people at the Federal or State level and getting 
it themselves and then being able to disperse it to the public 
so that it was consistent, it didn't cause confusion, didn't 
cause panic.
    What do you propose for information sharing for the CDC and 
the public health people on through that will sort of help that 
process, be one that's a message of consistency that flows all 
the way down to the local level so that people have some 
appreciation and feeling of security that they're getting 
accurate information and that they can rely on it?
    Secretary Thompson. We've been tempted to rectify that 
problem. In the last 10 days I have had a telecommunications 
conference with the head of CDC, Jeff Koplan, and myself, with 
all the State health directors on a Saturday afternoon. And it 
went very well. Since then, we've had a teleconference with the 
State legislative leaders, the National Governors organization, 
the American Hospital Association and the American Medical 
Association. Every day in the last 5 days we've been holding 
teleconferences with the press from my office, with health 
officers and myself.
    So we are reaching out, getting as much information as 
possible. We've also put up on the Web site at CDC how to 
handle anthrax and information that you need to know. We also 
opened up the 24 hour hot line for anybody that wants to call 
into CDC. We also have a 24 hour hot line going into our war 
room downstairs on the sixth floor. So there's plenty of ways 
that you can get information, and we're trying to educate the 
American public, and we're trying to give as much information 
as we possibly can about public health.
    That's why we're reaching out with these teleconferences, 
these press conferences and these 24 hour hot lines that we set 
up at CDC and here in the Humphrey Building.
    Mr. Tierney. The feedback is that those hot lines have been 
extraordinarily helpful. So I want to thank you and your staff 
for that, but ask you, that 24 hour, 7 days a week hot line, is 
that something you intend to continue?
    Secretary Thompson. For the foreseeable future, I don't 
know when this terrible thing is going to----
    Mr. Tierney. You have no plans of taking it down, or 
whatever, because it has gotten a great response, people are 
receptive to it.
    Secretary Thompson. We're trying to. We're trying to do 
more. We're reaching out, you know, wherever we possibly can, 
and other groups, now we're looking into the specialized 
medical groups, especially the emergency wards, being able to 
have a teleconference with them. A lot of those were on the 
American Medical Association, I think there were 50,000 doctors 
on that teleconference hookup that particular day that Jeff 
Koplan and I did it. So we know that there's an interest out 
there, and we're trying to do more of that, Congressman. And if 
you've got any suggestions, we'll be more than happy to take 
them up and try to implement them.
    Mr. Tierney. Thank you very much.
    I yield back the balance of my time.
    Mr. Shays. I thank the gentleman.
    We have another new member, Dr. Weldon, and then I'll 
finish up.
    Dr. Weldon. Thank you, Mr. Chairman.
    Secretary Thompson. I've tried to get hold of you and 
return your call. I had my deputy secretary call you.
    Dr. Weldon. Well, thank you for trying to get back. And 
certainly I want to thank you for all the work that you're 
doing in this arena. I've been listening to you and you're 
sounding less like a lawyer and more like a doctor when I hear 
you on television. [Laughter.]
    Mr. Shays. That may not be a compliment. [Laughter.]
    Secretary Thompson. In this case I'll take it as one.
    Mr. Shays. You should.
    Dr. Weldon. And I just got here, so I apologize if I cover 
some territory that maybe already has been covered.
    But the two postal workers that died, I understand one of 
them had been in the emergency room and had been sent out and 
then came back. And as I'm sure you know, the nature of inhaled 
anthrax is, it's very fulminant and in its very early hours of 
presentation mimics the flu or a cold. I heard you mention in 
response to one of the questions a very high level of interest 
amongst the medical profession. Can you just briefly outline 
some of the things HHS is doing to educate the medical 
profession, particularly in the Washington, DC, area, to look 
for certain indicators that they may be dealing with anthrax?
    Secretary Thompson. I'd rather have Scott Lilibridge answer 
that question, because he's in charge of that particular 
portion of it.
    Mr. Lilibridge. Just a few things, sir. Some of the things 
that they've done to help educate the medical community 
actually started over the past several years. They've included 
work with the American College of Emergency Physicians to help 
develop a curriculum that could be used to help educate their 
staff, their officers, their physicians that work in that 
guild.
    The other things that are going on presently in town, and 
more of a real time effort, is our work with HHS with the 
Department of Health, the District Department of Health. It has 
involved quite a bit of information, health alerts, it's 
involved some of the disease recognition activities and a 
number of continuous press briefings to update the public on 
different aspects of cases as they emerge and information about 
how they may present and what to be on the lookout for.
    On a more long term basis, and a national basis, things 
like the Health Alert Network are beginning to send out things, 
particularly during this event, on a more real time event with 
clinical information about sensitivity to the drugs, updates on 
clinical findings in terms of States and locations, and 
beginning to help people piece together the national mosaic and 
how this is fitting together.
    Dr. Weldon. I'm curious about the level of cooperation from 
DOD. I was in the Army for several years, and there were some 
fairly knowledgeable experts on these issues, anthrax, 
bioterrorism in general. Are you finding the level of 
cooperation to be very good, are you getting a lot of data and 
help from the experts in the various branches of the military 
that are working in this arena?
    Secretary Thompson. Congressman, we really have. We're 
cooperating very nicely. What I did is I took a hearing room 
down on the sixth floor of the Humphrey building and turned it 
into a huge room, a clearinghouse, a conference room. And we 
have people there from the Department of Defense, and from FEMA 
and from the Public Health Service. That is open 24 hours a 
day.
    We also have meetings every morning, somewhere around 7:30, 
8 a.m., to get intel, which is from the CIA, Department of 
Defense, from the FBI and from the Public Health. Those 
meetings are very good because we're exchanging information. 
That exchange of information is going on throughout a 24 hour 
day. Our hearing room downstairs is open 24 hours a day, 7 days 
a week. And Scott Lilibridge is in charge of that, and he's 
pulled together a great team. It's right across the corridor 
from my office, so I get over there very frequently to find out 
what's going on.
    We also have meetings from the various agencies, almost on 
a daily basis.
    Dr. Weldon. I'm sure you've probably covered this already, 
but being a physician myself, I've had Members of Congress 
approach me about just putting everybody on antibiotics and 
I've had to explain that may not be the appropriate thing to 
do. People can have side effects, occasionally you get rare, 
serious side effects, occasionally life threatening side 
effects. And at least in the case of the House and Senate 
exposure, the surveillance of testing the nasal swabs on the 
employees, staff, has shown that the original number of 28 or 
30 people----
    Secretary Thompson. Thirty-one today.
    Dr. Weldon [continuing]. It's limited to them, as I 
understand it. It would be inappropriate to take all the 
thousands of people who work in these buildings and put them on 
antibiotics. And ditto for the postal workers, that it's 
appropriate for the ones at high risk who have been exposed to 
be put on antibiotics. But for the others, to do the 
surveillance and determine if there has been an exposure level.
    Secretary Thompson. I addressed that in my statement, 
Congressman Weldon. I indicated we're going to be much more 
aggressive dealing with postal workers. And when we find that 
there has been an exposure, we're going to go in there and 
treat them with prophylactics much more aggressively than we 
have in the past, just because we have found that it needs to 
be done.
    Dr. Weldon. I totally support that, particularly the ones 
in that Brentwood facility. I understand that part of the 
problem there was, those letters came through a letter sorting 
machine that they clean at the end of the day with a compressed 
air gun, and it may have just thrown the anthrax up in the air 
and these poor souls may have inhaled lethal amounts right at 
that time.
    Secretary Thompson. That is being examined. We do not have 
conclusive evidence that's what took place, but that is part of 
the speculation that took place.
    Did you want to answer that, Scott?
    Mr. Lilibridge. No, I just wanted to add, that's exactly 
correct. Those individuals at Brentwood are being prophylaxed 
at this time, and an ongoing environmental investigation is in 
progress.
    In lieu of having all the results, we've gone ahead and 
erred on the side of caution, and began to prophylax that 
population as well as looking at the substations that drain or 
relate to Brentwood.
    I do want to mention two things, one, compliments to the 
Mayor and the District health officer for their continued 
stewardship of this issue and keeping the message clear, 
informing the public and playing a key leadership role in this 
response.
    Dr. Weldon. Well, thank you very much. Before I yield back, 
I want to thank all of you for the hard work you're doing, 
particularly you, Mr. Secretary. I certainly thank the 
President for the leadership role he is providing our Nation in 
this arena. By him putting all the resources of agencies like 
yours to work to combat this terrorist attack that we will be 
able to be victorious in the end, and America will be able to 
get back to business.
    Thank you so much, and I yield back.
    Mr. Shays. I thank the gentleman very much.
    Mr. Secretary, I'm last, and I have a number of questions. 
I'd like to see if I can get through them.
    And I want to say to you that besides what our committee 
has done for the last 2\1/2\ years, basically the members here 
were on a committee that oversaw HHS for 4 years before that, 
and we've seen the Department of Veterans Affairs for now 8 
years, and have gotten into issues like Gulf war illnesses and 
the whole military anthrax program.
    So one of the questions I'm going to be asking is how your 
program differs in terms of anthrax to the needs of the 
military. But before I do that, I want to come back to the 
original question I had asked. It's clear that you are not 
advocating at all dealing with smallpox, that all Americans be 
vaccinated.
    Secretary Thompson. That's right.
    Mr. Shays. But that you are looking to have a greater 
supply. And it's clear that we have 15 million, 12 million of 
the finest quality and 3 million that's a little lesser quality 
and you can dilute that.
    I just want to be very clear, though. In terms of the 
dilution, the five to one, will this be a sign-off by FDA or an 
acknowledgement that you've done it, and how--I don't need to 
know about how we're going to determine the trial now, because 
I'm going to get to other questions. But I need to know, 
really, whether FDA signs off on this, are you going to 
overrule FDA and so on?
    Secretary Thompson. FDA is working in collaboration with 
us. But I think Dr. Egen should respond directly to that 
question.
    Dr. Egen. I think the dilution studies are being conducted 
under IND. So it's with the approval of the FDA. The FDA will 
oversee the trial.
    Mr. Shays. So if they're successful, FDA will acknowledge 
that they're--and sign off?
    Dr. Egen. Oh, absolutely. And that's being done now.
    Mr. Shays. In terms of the production of new smallpox 
vaccine, I'm interested that you have to go through the trials, 
you have basically three phases after you've dealt with the 
animal side of the investigation. And I'm not talking about the 
typical argument that the pharmaceutical industry can say FDA 
takes too long. We're not talking about that kind of 12 years 
and sometimes the pharmaceutical companies can be at fault. 
Here we're talking about wanting it, agreeing to speed it up as 
quickly as possible.
    But you still are going to do all three phases, correct?
    Secretary Thompson. Correct.
    Mr. Shays. Do you still want to respond?
    Dr. Egen. Yes. I think you're starting off at a better 
point. You're starting with a virus, a vaccine virus that 
you've already worked with and you know is effective against 
smallpox. It's eradicated smallpox in the world. So it's not 
like we're taking a disease, isolating the disease----
    Mr. Shays. It's a new vaccine?
    Dr. Egen. It's a new vaccine in one way, in a sense, it's 
going into a different cell substrate. And there is the 
possibility of change there. For example, using a human cell or 
an animal derived cell, nobody's going to make the vaccine on 
the skin of calves any more. We're going to do it in cell 
substrates.
    And then look for or use the surrogate markers that we've 
got. Dr. Fauci talked earlier about looking at the take rate. 
So that's certainly one of the things----
    Mr. Shays. And we would do that with a new vaccine?
    Dr. Egen. We'll look at that, we'll do that with the new 
vaccine, again, under IND, looking for take rate, looking at 
immunological responses to the vaccine, comparing those to the 
currently licensed vaccine, the current vaccine, the dry 
vaccines, from Wyeth Lederle, and looking for similarity of 
immunological response, whether those immunological response 
are cross-neutralized----
    Mr. Shays. That's going to tell you about the efficacy, but 
it may not tell you about the safety, correct? In other words, 
with the old vaccine, 1 out of 1 million would literally die. 
Somewhere, I heard the number 200,000 would have very serious, 
1 out of 200,000 would have a very serious adverse reaction, 
which raised the question of the vaccinia immunoglobulin which 
we are producing now, which is to deal with those adverse 
effects. We have to go through a study, a trial on that as 
well, with VIG?
    Dr. Egen. I think if you're going to be licensing new 
sources, going through studies to compare them with the 
currently licensed material.
    Mr. Shays. And are we in the process of trying to get 
additional VIG as well?
    Dr. Egen. Yes.
    Mr. Shays. But we won't have to do more studies for that?
    Dr. Egen. Well, to compare those new sources or new 
preparations with older, existing preparations. So there are 
some studies, yes.
    Mr. Shays. Going back to, just now going to anthrax, our 
committee has taken exception to the mandatory program that the 
military had for anthrax for a variety of reasons, but one was 
it was sole-sourced. Another was that it was an old vaccine and 
we had wasted many years developing a new vaccine, six shots. 
They arbitrarily decided to give three shots instead of six, 
even though the protocol doesn't allow for that. They did it 
because ultimately they started to run out.
    We literally have a few, 10,000 of it, I mean, we don't 
have a lot. That's public record. And the issue is, what kind 
of pressure ultimately, how are we going to respond to BioPort? 
They have 11 lots of it, around 200,000 a lot, I don't 
understand.
    Secretary Thompson. There are about 5 million.
    Mr. Shays. But some of it is their new batch, and the other 
is old batch that has lost some of its efficacy, its potency. 
So you all are going to have to make a decision on the new 
production, and you're going to have to make a decision on the 
2 to 3 million of old lots vaccines. And I'm interested to know 
whether you are basically going to just allow them to use it, I 
want to know what's happening here. I want to have a sense that 
we aren't pressuring FDA into saying, OK, let's move forward 
because we have a national emergency.
    Dr. Egen. Are you asking the Secretary if he's pressuring 
FDA to do things?
    Mr. Shays. I'm asking about the real concern. Let me just 
be real clear about it. This is not new territory for us. 
During the Gulf war, we decided to have 700,000 of our troops 
take peritostigmine bromide [PB], and we used it as a 
prophylactic. It was an approved drug, but we used it in a 
prophylactic way.
    And there are some real questions as to whether that was 
advisable, and there were some real questions about whether the 
FDA shouldn't have stepped in, and there were some real 
questions about whether protocol was followed. The troops 
weren't told about how they should take it, when they should 
take it, records weren't kept on who took PB and so on. So this 
is a history that goes well beyond any Secretary.
    And I'm just concerned we are in a warlike condition, and I 
would just like to know what the policy will be of the 
Department.
    Mr. Shays. Let me answer that. They have about 5 million 
samples of vaccine, 3 million of which is licensable and 2 
million of which is going to have to be inspected. FDA is going 
to have to do the inspection, FDA is going to have to go and 
inspect their new building that they're remodeling, or 
reconditioning a new building, but reconditioning and 
remodeling it. They have just filed, as of last Friday, an 
application for certification, and FDA will be going in there 
as soon as its completed. If it's completed and it's up to the 
specification that FDA approves, they should be operational by 
November 22nd. It was originally going to be the 15th, now it 
looks like it's going to be the 22nd.
    But I can assure you, Congressman, nobody is pressuring FDA 
to approve this. There's been an ongoing conflict between FDA 
and BioPort for some time. That conflict has been brought on 
mainly by BioPort for not performing a good manufacturing 
system.
    They are improving that and modernizing and cleaning their 
plant and now we go in and be inspected by FDA. And FDA will 
give it a very close and scrutinize very carefully all the 
problems they've had in the past to make sure that it's up to 
speed before it introduces and starts manufacturing again.
    As far as the 5 million, most of that will have to be 
reinspected, yes.
    Mr. Shays. Let me just say that this, we are also asking 
the same question of DOD as well, because in this case it 
becomes an investigatory type drug. And I would want to know if 
we will require informed consent by those who will be taking 
the drug. Smallpox, if we move forward--I'm sorry, I've moved 
to smallpox.
    Dr. Egen. Will it be done under IND?
    Mr. Shays. Yes, OK. And that will require informed consent?
    Dr. Egen. When it's done under IND, it does require 
informed consent, absolutely. The dilution studies----
    Secretary Thompson. No, he's talking about the new stuff. 
You will have to be informed, and the person, before he 
receives the smallpox, would have to be informed and would have 
to give his or her consent.
    Mr. Shays. Mr. Secretary, is there a question we should 
have asked that you want to respond to?
    Secretary Thompson. No, I think--[laughter]--you've done a 
very effective job and I'm very happy to have you here. I hope 
you stop down and see our room before you leave.
    Mr. Shays. We will stop down.
    Secretary Thompson. And I want to thank you.
    Mr. Shays. And I want to thank you, and say the President 
and the country is fortunate to have you as Secretary.
    Secretary Thompson. Thank you very much, Congressman.
    Mr. Shays. We'll have a 1-minute break and then we'll call 
our next witnesses up.
    [Recess.]
    Mr. Shays. Thanks to the courtesy of the Deputy Assistant 
Secretary of Defense, she's waiving what we have as a typical 
protocol and allowing our next three panels to meet as one 
panel. And so I'm going to be asking all three panels, I'll be 
calling them all up at once. We have Dr. Anna Johnson-Wineger, 
Deputy Assistant to the Secretary of Defense for Chemical/
Biological Defense Programs, Department of Defense.
    We have Dr. Nancy Kingsbury, Managing Director for Applied 
Research and Methods, General Accounting Office. And you'll be 
accompanied by, and behind you will be Janet Heinrich, Dr. 
Sushil K. Sharma, and Jack Melling. I'd like to swear them in 
as well.
    And then Stephen G. Sudovar, thank you, who is president 
and chief executive officer of EluSys Therapeutics, Inc., and 
Dr. Una S. Ryan, president and chief executive officer, AVANT 
Immunotherapies, Inc.
    I need to swear you all in, and I would ask you to stand. 
Do we have everyone here?
    Dr. Kingsbury. Dr. Melling seems to have taken more than 1 
minute.
    Mr. Shays. Well, if he doesn't get back soon, we won't be 
able to hear from him. We'll take a minute here. He is such a 
delightful gentleman, I do want to make sure he's sworn in.
    I will now ask all of you to stand and I'll swear you all 
in.
    [Witnesses sworn.]
    Mr. Shays. Note for the record that our witnesses have 
responded in the affirmative.
    Dr. Wineger, I do want to thank you for your flexibility in 
the protocol issue. I think it will make it easier for all of 
you to make your statement and easier for us to question all of 
you. You won't all--it will make it go by a bit quicker and 
more efficiently. So thank you.
    I'm going to tell you, you'll have 5 minutes and then 
you'll have another 5 minutes to roll over. Given that you've 
been so generous, I'll even give you a bit more than the rest.

  STATEMENT OF ANNA JOHNSON-WINEGER, DEPUTY ASSISTANT TO THE 
SECRETARY OF DEFENSE FOR CHEMICAL/BIOLOGICAL DEFENSE PROGRAMS, 
                     DEPARTMENT OF DEFENSE

    Ms. Johnson-Wineger. Thank you, distinguished members of 
the panel. I'm honored to be here today to address your 
committee and to try to answer any questions that you might 
have.
    As a matter of introduction, my name is Anna Johnson-
Wineger. I am currently the Deputy Assistant to the Secretary 
of Defense for Chemical/Biological Defense Programs. I have a 
Ph.D in microbiology and have spent 35 years working for the 
Department of Defense.
    At your request, I will focus my remarks today on force 
protection and in particular, on our current and planned 
capacity to immunize against outbreaks of disease that may 
result from intentional exposures to biological warfare threat 
agents. As you know, these include a number if etiologic agents 
and you asked specifically that the Department address anthrax, 
smallpox, tularemia, plague, hemorrhagic fevers, etc.
    I am also prepared to address my understanding of the 
current FDA regulatory environment for the developmental 
testing and licensure of vaccines for protection against 
biological warfare threat agents and the role of the private 
sector in the development of these needed vaccines. I believe 
the vaccines are and will remain a cornerstone of force 
protection against biological warfare threats for the military.
    I will focus my testimony on the medical aspects of force 
protection, realizing all the while that the Department of 
Defense does indeed have a comprehensive program of which 
medical is one component. Each year we have a technology area 
review and assessment. This last year that TARA group 
characterized our medical biological defense research program 
as a ``well-balanced, strategic road map focused on warfighter 
requirements.''
    I would also like to mention that in accordance with the 
Government Performance and Results Act, which I know you 
support strongly, we have developed performance metrics in the 
form of technology readiness levels and exit criteria have been 
developed in support of our medical biological defense research 
program.
    Finally, I wanted to point out that all aspects of our 
program are encompassed without our joint future operational 
capabilities for the military. Clearly, the discovery, 
development and production of FDA licensed vaccines for 
biological warfare defense embodies a very challenging 
undertaking for us.
    With specific regard to anthrax, the FDA licensed anthrax 
vaccine represents old, well established technology. Each of us 
is familiar with the difficulties encountered in the FDA 
compliant production of the anthrax vaccine in BioPort, so it 
is not my intention to review these problems at this point. 
However, I am prepared to answer any questions that you might 
have.
    I think that one of the things the Department of Defense 
learned from this experience, and indeed, there are many 
things, is that while successful vaccine research and 
development is necessary, it alone is not sufficient to meet 
our force protection needs. FDA compliant production 
capability, with sufficient capacity, is essential for our 
force protection. Establishment and licensure of vaccine 
production facilities, whether public or private, is a 
relatively expensive, technically complex, and long lead time 
project for each and every vaccine and procurement program that 
we support.
    As you are well aware, the former Deputy Secretary of 
Defense, in his July testimony concerning anthrax vaccine, 
before the Subcommittee on Military Personnel of the House 
Armed Services Committee, testified that he had directed that 
an independent panel review and report on DOD's overall 
management of acquisition of vaccines. The report of that panel 
was submitted to the Congress this year as part of DOD's 
response to Section 218 of the Floyd Spence National 
Authorization Act for Fiscal Year 2001, Public Law 106-398. 
This report addresses a number of issues concerning acquisition 
of biological defense vaccines and I'd like to point out just a 
few of those to you.
    This independent panel pointed out that the DOD has been 
unsuccessful in attracting large, established vaccine 
manufacturers to support our biological defense needs. The 
independent panel found that participation by the 
pharmaceutical industry is an essential element in securing FDA 
licensed, safe and effective vaccines. They found that barriers 
to industry participation include the size and scope of the 
vaccine requirements, episodic DOD production requirements that 
lead to idle manufacturing, industry concerns about program 
stability and political considerations, DOD procurement 
practices and acquisition regulations that are inconsistent 
with the vaccine industry's best practices and model for 
success.
    The panel recommended that application of a combined, 
integrated approach by the Department of Defense and industry 
would enable a successful program.
    Three key findings of the independent panel included the 
following points. No. 1, the scope and complexity of the DOD 
vaccine requirement is too great for either the DOD or the 
pharmaceutical industry to accomplish alone. Two, the resources 
do not match the requirements. Using an eight scale vaccine as 
a target, the panel estimated that the DOD acquisition of 
vaccine production would require between $2.4 billion and $3.2 
billion in R&D costs over a 7 to 12 year period.
    Additionally, when considering a Government owned, 
contractor operated or a contractor owned, contractor operated 
facility, with an initial capacity to produce three or four 
vaccines, including pilot production and scale-up, would 
require approximately $370 million in construction. This is in 
close agreement with the DOD estimate of $386 million.
    Finally, the independent panel pointed out that vaccine 
acquisition is indeed different from weapons acquisition, and 
success within the Department of Defense will require different 
procedures. The panel recommended a lean, streamlined, 
technically competent vaccine acquisition management 
organization. Strong technical leadership is imperative at all 
levels, from the laboratory to senior management. Stable, long 
term funding with full flexibility to move resources to match 
these requirements is essential. Procurement practices need to 
move to closely approximately industry practices. And vaccine 
programs must be fully integrated from discovery through 
licensure.
    I have hosted several meetings of a Federal interagency 
working group on vaccine acquisition. Participants in that 
group have included representatives from the Department of 
Human Health and Services, such as CDC, FDA, NIH, the Public 
Health Service, the Office of the Surgeon General of the United 
States, as well as representatives from the Department of 
Agriculture, USAID, the National Security Council, the Office 
of Management and Budget, and the Office of Science and 
Technology Policy. That group generally agreed that an approach 
and the need for GOCO or a COCO vaccine production facility to 
complement the private sector capacities is what is required.
    In the interest of time, I will ask that the rest of my 
statement be entered into the record as written, and would just 
like to conclude with a few comments. Because I know that 
you're particularly interested in our work on a new anthrax 
vaccine and a new smallpox vaccine, so just let me add a few 
more comments here.
    We do have indeed an approach for a new anthrax vaccine. 
And we have a candidate vaccine, which is a recombinant 
protective antigen product. At present, the joint program 
office projects attainment of a baseline amount of this 
material in the year 2007. And we are working with the DynPort 
vaccine company to make this happen. And in accordance with 
your questions earlier, that will be done under the full 
jurisdiction of the FDA with phase one and phase two studies 
for safety and immunogenicity and will be administered under 
written informed consent during those early phases of the 
study.
    With regard to smallpox, as was mentioned in previous 
testimony, prior to 1972, smallpox vaccination was routine. 
Wyeth Laboratories produced the licensed vaccine and the 
remaining stocks are, as you know, under the control of CDC. 
The DOD has an R&D program to identify potential new vaccines 
and new anti-viral drugs as well. A smallpox vaccine is one of 
our highest priorities, and the DOD has contracted with 
Bioreliance to make small amounts of good manufacturing 
practices production. And we have a phase one clinical trial 
scheduled for January 2002.
    We hope to be able to accelerate production of that 
material, and we are currently evaluating ways to accelerate 
our time line for a new smallpox vaccine.
    As you are aware, we have a comprehensive program looking 
at many other vaccines. I think that addresses the comments 
from this morning, that while anthrax and smallpox are our No. 
1 and No. 2 priorities today, the threat is indeed much broader 
than that.
    And I would just like to mention that we do have ongoing 
research and development programs looking at such things as 
multi-agent vaccines, medical counter-measures for a number of 
other threat agents, and needle-less delivery methods for some 
of the recombinant protein vaccines. I think that you would 
agree that the DOD vaccine program is technically very complex.
    Our requirements are diverse and challenging. And for the 
near term, our vaccine dependent medical readiness for force 
protection against biological weapons and the terrorist use 
will be limited. Over the long term, we are committed to 
effective immunization as one cornerstone of force protection 
for the military. Realization of this goal will indeed require 
changes in our business practices, expanded participation by 
the pharmaceutical industry, hopefully complemented by a 
dedicated vaccine production facility, and indeed, a long term 
national commitment to the success of this program.
    [The prepared statement of Dr. Johnson-Wineger follows:]
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    Mr. Shays. Thank you very much, Dr. Wineger.
    Dr. Kingsbury.

 STATEMENTS OF NANCY KINGSBURY, MANAGING DIRECTOR FOR APPLIED 
RESEARCH AND METHODS, GENERAL ACCOUNTING OFFICE, ACCOMPANIED BY 
  JANET HEINRICH, DIRECTOR, HEALTH CARE-PUBLIC HEALTH ISSUES; 
 SUSHIL K. SHARMA, ASSISTANT DIRECTOR FOR APPLIED RESEARCH AND 
             METHODS; AND JACK MELLING, CONSULTANT

    Ms. Kingsbury. Thank you, Mr. Chairman, and I want to thank 
you for inviting us here today to report to you on this 
specific work we've done at your request that well pre-dates 
our current adventures with bioterrorism, to examine the 
changes in the manufacturing processes at BioPort and what FDA 
did or did not do with respect to those. And I'll get to that 
in just a moment.
    You chose to swear in my colleagues, and that's fine. I 
want to be sure that you understand why they're here. Jan 
Heinrich is responsible for our recent work on the capability 
of State and local governments to respond to bioterrorism, that 
the health care group did. Dr. Sharma worked with me and did 
most of the work on this manufacturing changes job. And Dr. 
Jack Melling is one of our consultants, and in fact, was 
responsible for the production facility in the UK that produced 
anthrax vaccine, was on their licensure entity and also has run 
a biologics project in the United States. So we rely very 
heavily on him for his expertise.
    Mr. Shays. I think what we'll do is, since they'll need a 
microphone to respond, we'll have two sit on this side and one 
sit on this side, and you can come on up.
    Ms. Kingsbury. Report to the front, as the gentleman 
suggests.
    I think this committee is very familiar with the process 
that FDA uses for regulation under normal conditions. You asked 
us to look at certain changes that took place to the vaccine 
manufacturing process, beginning in 1990. In 1990, BioPort, or 
it was actually the Michigan facility owned by the State of 
Michigan at the time, introduced two new fermenters. They 
shifted from a glass fermenter to a stainless steel fermenter 
in 1990. That was reported as required under regulation to FDA 
in December 1990 and FDA approved those changes in 1993.
    However, in 1993, the Michigan facility also introduced two 
other similar, but not identical, fermenters. And despite some 
advice from DOD and others that they were required to submit to 
notify FDA about this, they did not do so until 1999. They did 
report the fermenter change in 1999 and FDA approved that 
change in May 2001.
    With respect to filters, the Michigan facility also changed 
filters in 1990, and the principal change was to move from a 
ceramic filter to a nylon filter. They changed the type of 
filters again in 1996 and 1997. When you asked us to do this 
work, we could find no evidence that these changes had been 
reported to FDA. And in December 2000, we met with FDA to 
discuss the matter with them. They admitted at the time that 
they were not aware of those changes, and about 2 months later, 
in February 2001, they wrote a letter to BioPort asking them to 
provide information about the impact of those changes. But of 
course, this is nearly a full decade after the initial changes 
were made, and so BioPort submitted information to FDA in April 
2001. That information was what they could reconstruct from 
their records. It had been the tests that were available, they 
seemed to be fairly straightforward.
    FDA did approve the filter changes in July 2001. But I 
think it's important to recognize that the data provided by 
BioPort were not the sort of data that might be provided today 
if a license amendment were filed about that sort of change. 
And we know from, or at least Dr. Melling advises, that nylon 
filters absorb less protein than ceramic filters, so there is 
perhaps a theoretical reason to want to explore the question of 
whether the vaccine produced after these filter changes is 
different from the vaccine produced before these filter 
changes. That issue has not been fully explored.
    When we couldn't find very much information about the 
actual nature of the vaccine changes, we did look for other 
evidence that might suggest that this issue of whether the 
vaccine changed should be examined. And we found two different 
kinds of evidence. One was a study that the U.S. Army had done 
at USAMRIID to apply a new methodology to attempt to measure 
the level of protective antigen, which is one of the components 
of the vaccine toxin in lots produced before and after the 
filter changes. That study suggested that there was a much 
higher level of protective antigen in the vaccine produced 
after the filter changes.
    The author of that study, which has never been published, 
was quite cautious about what could be read into this 
information. But we have been trying to see whether that 
doesn't suggest that other studies might be warranted.
    In addition, as you know, we have done a survey at GAO and 
we have been looking at the epidemiological research that 
others are doing on the health conditions of people who served 
in the Gulf war and who did or did not take the anthrax 
vaccine. Our study suggests, which will be published shortly, 
that the levels of people reporting, at least in our sample, of 
fairly serious systemic reactions to the vaccine are 
considerably higher than the levels that we are led to expect 
by looking at the product insert for the vaccine, which 
admittedly were estimates that were made during the clinical 
trials in the late 1960's, so it's old information. But it's 
the best we have.
    So we think that these two things also suggest that a 
little more study of the impact of the filter change might be 
good medical practice.
    We note in closing that public health vaccines that are in 
common use worldwide are soft of self-monitoring. If a problem 
arises, people tend to find out about it, they tend to look 
into it. Biodefense vaccines are in a different category, 
because the disease against which they are created is not 
commonly experienced until we have an emergency, and we think 
that suggests that both the manufacturing practices and the 
surveillance of people who take the vaccine ought to be 
somewhat more rigorous than what might otherwise be the case. 
And we leave you with that thought, and we'll be happy to 
accept your questions.
    [The prepared statement of Ms. Kingsbury follows:]
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    Mr. Shays. Thank you. We've heard from the Department of 
Defense and from GAO and now we have two people from the 
private sector. Mr. Sudovar, we'll be happy to hear from you.

STATEMENTS OF STEPHEN G. SUDOVAR, PRESIDENT AND CHIEF EXECUTIVE 
OFFICER, ELUSYS THERAPEUTICS, INC.; AND UNA S. RYAN, PRESIDENT 
  AND CHIEF EXECUTIVE OFFICER, AVANT IMMUNOTHERAPEUTICS, INC.

    Mr. Sudovar. Thank you, Mr. Chairman and members of the 
committee. It's indeed my privilege to be here today, and I 
thank you very much for inviting us.
    I'll try and be brief in my comments and not cover ground 
that's already been covered by others who have testified before 
me. So I'll try and move fairly swiftly through reading and 
focusing on those points I think might be germane to the 
conversation that we have in the aftermath of this.
    One of the key points I'd like to address today is that it 
is just as important to pursue other biomedical and 
biotherapeutic solutions in addition to vaccines that can 
protect the American people from a variety of pathogens and an 
increasingly sophisticated enemy. The biotechnology industry is 
engaged in a tremendous research and development effort 
dedicated to that end.
    Another key point that I'd like to make and discuss today 
is the critical importance of Government support of this 
industry, largely made up of small companies that have no base 
of marketed products or revenues to fund research. I'm here 
today representing BIO, that is the biotechnology industry 
organization, whose role in American health care, safety and 
security is becoming more apparent, I believe, every day. BIO 
represents 1,000 biotech companies, academic institutions, 
State biotech centers and related groups in all 50 States of 
America. BIO's members are involved in research and development 
of products for health care, agricultural industry and the 
environment. BIO members recently formed a special biodefense 
task force, of which I am a member.
    I also am president and CEO of EluSys Therapeutics, Inc., 
and before that held leadership positions with the global 
pharmaceutical manufacturing industry for almost 25 years. My 
company, and the biotechnology industry, are engaged in cutting 
edge science that is uniquely poised to benefit Americans; 125 
approved biotechnology products and vaccines have helped some 
250 million people worldwide; 75 percent of these medicines 
have been approved in the past 6 years.
    EluSys is an example of how the biotechnology industry 
works. We are a fledgling company that has licensed early stage 
technology from academia and are developing safe, effective and 
marketable therapeutics for a wide range of medical needs. 
Since the company's founding back in 1998, we have worked 
collaboratively, first with academia, and now with the U.S. 
Army Medical Research Institute of Infectious Diseases 
[USAMRIID], to pursue development of our unique therapy against 
potential biological weapons of mass destruction, such as 
anthrax, hemorrhagic fever, the Ebola virus, plague and 
smallpox. We've done this without financial assistance from the 
Government.
    I'd like to take a moment just to explain, at least from my 
perspective, the therapeutic options our Nation needs to 
explore in connection with biological weapons and the diseases 
they may cause. There are actually three levels. We've heard 
about vaccines, of course. We've talked a great deal this 
morning about antibiotics. What I'd like to talk a little bit 
more about are therapeutics.
    Each of these approaches, other than the antibiotic course, 
each of these approaches is critical. All are necessary and 
none of them is in a stage where we can rest easily.
    Let me explore each of these treatment options in a little 
more depth so you can understand how they differ and how they 
complement each other. I believe we can skip over the vaccine 
section, since we've talked a great deal about it. I think that 
the vaccines obviously have a major role to play within the 
crisis, particularly that we're facing now, against numerous 
pathogens. I think Dr. Wineger has covered both the vaccines 
most important to us, the smallpox vaccine and the vaccine for 
anthrax.
    There are, I think, additional considerations that we 
should consider, especially in regard to military versus 
civilian populations. As we've talked about, the anthrax 
vaccine requires some six injections over about 18 months, plus 
booster shots to provide full immunity. While this may be 
conceivable in the military population, it's clearly 
unrealistic, I believe, in the civilian population.
    We are fortunate to have effective antibiotics already 
available. In addition, there are anti-viral therapies 
currently available for cytolomegalovirus, HIV-AIDS and herpes 
that may or may not be effective against viruses used in 
biowarfare. Biotech and biopharmaceutical companies are working 
to find new alternatives.
    Antibiotics inactivate or kill bacteria, including anthrax. 
But they can't help, at least they have not proven to help, 
someone who's experiencing symptoms. If the bacteria already 
has released toxins into the bloodstream, there is little that 
can be done. It is too late. That is where blood cleansing 
technologies like the one EluSys is working on can come into 
play.
    The unique heteropolymer system which we have discovered at 
EluSys is developing uses for two monoclonal antibodies 
chemically joined together like biological double sided tape. 
One of these antibodies sticks to the toxin, in this case, 
anthrax. The other bonds to a receptor found on the human red 
blood cell. Red blood cells then carry the pathogen to the 
liver for destruction and return unharmed to the normal blood 
circulation. This whole process happens within minutes.
    Unlike vaccines, antibiotics and anti-virals, the HP system 
can be engineered to be activate against anything that 
circulates in the blood stream, such as bacteria, toxins and 
viruses.
    To help the public, we need more post-exposure options. It 
is not feasible or practical to vaccinate the entire 
population. There are side effects to these vaccines, and the 
benefits probably would not outweigh the risks in most cases. 
Nor would antibiotics protect people from a possible scenario 
in which a pathogen is released through a building's air 
system, for example. Many people could be exposed and infected 
without knowing it. There would be no telltale signs of white 
powder in an envelope. A few days later, when they started 
experiencing symptoms and went to their doctors, it may in fact 
be too late.
    Once a toxin has been released into the blood stream and 
symptoms have appeared, there's no evidence that a course of 
antibiotic therapy will be effective in preventing death. The 
EluSys heteropolymer system, however, by removing the toxin 
from the blood stream, has the potential to do just that. Since 
it works against the toxin, it may buy the crucial time to 
allow for later stage antibiotic treatment. Companies in this 
field have identified a variety of needs and barriers that 
hinder quick, large scale development and production of several 
products. We at BIO have identified some 20 companies that are 
working on bioterrorist and biowarfare agents.
    But there are barriers, and let me provide you with my 
view, at least the prevailing view, I believe, among many 
industry leaders, of how to overcome these barriers. No. 1, the 
market for these agents, biological toxins, is small and it is 
uncertain. There's no guarantee that the vaccines or 
therapeutics we develop will ever be needed, and hopefully they 
will not.
    Because of that uncertainty, support from the venture 
capital and financial markets, which we depend upon, is 
limited. That is why we and other companies need the support of 
the Government to continue the development of these important 
drugs and devices and by that, I mean targeted funding by the 
Government, which will enable small and innovative companies, 
like my own, to significantly expedite the development of 
important agents against biological toxins.
    We've discussed our technology with many Congressman and 
Senators up here on the Hill. The single most often-asked 
question of me is, what would it take to expedite the 
development of your drug product. For example, normally it 
would take 4 to 6 years, in many cases, as long as 10 years, to 
get the EluSys antidote ready to treat human beings exposed to 
anthrax. Government funding on the order of about $50 million 
will enable us to develop the antidote in roughly 2 years, and 
we've laid a program out to do that, which we'd be glad to 
submit to the record.
    In addition, biodefense companies need long term Government 
contracts. This will help maintain consistent revenue streams 
so our companies can continue to draw support for biodefense 
and commercial applications of our products and technologies.
    The biotechnology industry also needs support from 
Government that goes beyond funding and includes the following. 
No. 1, some protection from liability. The biotechnology 
industry needs Government to indemnify our companies. Fear of 
liability has clearly prevented many companies from even 
considering the development of vaccines, and in fact, many 
companies have discontinued programs for this very reason.
    No. 2, support for security measures. The nature of our 
research, to develop protection from those who want to harm 
people, puts our laboratories, our researchers and other 
personnel at increased risk. We ask the Government to support 
the additional security measures that we need.
    Third, FDA support. We talked a little bit about this 
today, but perhaps from a little different perspective. FDA 
needs to expedite the product review and approval process by 
allowing us to demonstrate efficacy through non-human, animal 
data only. I mention this because one of the problems we have 
is there is no naturally occurring disease called anthrax. It's 
a bioterrorist-created disease, which is inhalation anthrax. 
There is no way to do a well controlled clinical trial with 
human beings. There are very few people that will step to the 
control group in a trial of that kind, and particularly if 
they're in a control group without the benefit of our 
technology.
    So there needs to be an alterative means of approving 
products that can be utilized in this fashion for disease that 
are literally created. We believe that the FDA's regulations, 
which we've commented on and discussed with them, and we will 
submit for the record also our comments on those and not go 
into those now, that only human testing would be necessary, and 
of course, we do safety testing on large numbers of human 
beings.
    Let me just close by saying that I hope you have a better 
understanding of the array of approaches. It's clear that the 
use of biologicals in warfare and home land terrorism, which 
we've talked a great deal about, is a great threat to 
Americans. I want to say on behalf of the industry that we 
stand ready to work side by side with Government to stamp out 
this threat.
    Thank you very much for your time.
    [The prepared statement of Mr. Sudovar follows:]
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    Mr. Shays. Thank you for your time.
    Dr. Ryan.
    Ms. Ryan. Mr. Chairman and members of the subcommittee, I'm 
delighted to be here and very grateful for the opportunity to 
testify. I understand that time is short and so if I may, I'd 
like to enter my written testimony into the record and I will 
simply speak to the issues that haven't been covered in detail.
    I'm going to take it as a given that we need a vaccine. I 
could elaborate on that, but I believe both as a preventative 
and as a treatment, post-exposure, one needs the power and 
memory of the immune system to have been activated. So I'm 
simply going to talk about vaccines.
    I'm going to talk about those that we have and I'd like 
really to tempt you with what we could have if we were to make 
a wish list. I believe that the biotech industry is absolutely 
ideally part of the solution. We are not the pharmaceutical 
industry, we're small, we're nimble, we're unencumbered by 
profits. And we are extremely highly motivated to----
    Mr. Shays. You have no profits.
    Ms. Ryan. Exactly. The halo.
    Let me just start with a very brief review as an example 
the way I see the anthrax vaccine technology. Dr. Johnson-
Wineger has mentioned the BioPort, which I see as mark one 
vaccine. It's a complex mixture, the toxins are released into 
the broth, they have to be inactivated and an adjutant has to 
be added to make the vaccine more immunogenic. You know the 
disadvantages, multiple injections have to be given to get 
protection. It takes a matter of months, even up to 18 months, 
and we simply cannot anticipate terror attacks by that period 
of time. And it's expensive and difficult to make.
    On October 10th, AVANT--we don't need to go into the 
immunotherapeutics, just AVANT--licensed to DynPort a 
recombinant PA vaccine that you mentioned. I believe that this 
is much more precise. It should therefore be safer, meaning I 
think it will have fewer side effects. And it should be easier 
to manufacture. It's made in E. coli, a bacterium that 
replicates very quickly.
    But I believe that it will still be an injectable, and most 
people don't like shots. It will probably require multiple 
doses, and it will, as you've heard, take time to manufacture. 
So I consider that the second generation. But now, I think we 
need to talk about fighting this war and using the technology 
that's available now. I'd like to focus my testimony on what I 
believe would be much more rapidly protecting, single dose, 
oral, much more cheaply manufactured vaccines that I believe we 
could leapfrog into development very rapidly.
    Let me give you some examples. AVANT is an 
immunotherapeutics company. We make vaccines. We're experts at 
modern vaccine technology. We don't make the mass small margin 
vaccines of childhood prevention. We, for example, have a 
vaccine that raises your good cholesterol, but I digress.
    Let me get back to the program that I want to talk to you 
about. One of the things that we're doing in our peace time 
activities is producing single dose oral vaccines that very 
rapidly would protect travelers. This is to protect travelers 
against serious causes of bacterial diarrhea, things like 
cholera, typhoid fever, shigella, which is dysentery, E. coli 
and campylobacter. Now, those are things that can ruin a 
vacation, they can ruin a war, but they kill a lot of people in 
countries where they're endemic. Although we're focusing on the 
top five bioterrorism agents, I just want you to know that we 
have vaccines against these diseases under development now, two 
of them quite late stage.
    I don't want to go into the fact that they're there. If we 
were called upon for the country's defense, we would provide 
them. But what I want to talk about is something that I think 
could bring that user friendly technology to bear on anti-
biowarfare agents. So let me take the example of cholera and 
show you how that can be a launching pad for what I believe is 
a very rapid development of an anti-bioterrorism series of 
vaccines that have the same rapid protection and other useful 
characteristics.
    Let's take cholera. Our single dose cholera vaccine 
protects very rapidly, in a matter of days, not weeks or 
months. We know that you can get very high protective titres in 
7 days. And since they're on a curve going up after, just a few 
days there are probably protective titres. We simply haven't 
measured it earlier than a week.
    You see, what we're trying to do is have people get on a 
plane, have champagne, orange juice or cholera vaccine and be 
protected by the time they arrive. So speed is very important. 
So we call our cholera vaccine CholeraGarde. But because 
cholera, the vibrio cholera organism is very invasive, it can 
also be used as what we call a vector. And you might want to 
think of this as a Trojan horse.
    So we have already developed the Trojan horse. We know a 
lot about it. We can manufacturer it at GMP manufacturing, good 
manufacturing practice conditions. We will be entering pivotal 
phase three trials through the peace time FDA scenarios this 
year, in 2002.
    What I believe we can do is take what we call VibrioVec, 
which is essentially the cholera vaccine, and as if with a 
cassette, slip into it PA, the same recombinant PA that we have 
licensed to DynPort. But again, plague or any of the bacterial 
antigens that would protect against whatever the bioterrorism 
agent would be.
    Now, this is not some pipe dream that is far away. We have 
this vaccine approach in late stage trials now. You've already 
heard that there is currently no FDA, no regulatory mechanism 
for approving an anthrax vaccine. You can't do challenge 
trials, and you cannot do fail trials in an endemic area. It's 
just not possible to get one approved.
    But where I think I was hearing concern about sort of 
bypassing safety and efficacy trials at the FDA, I'm not 
talking about that at all. The Trojan horse itself will have 
gone through extensive trials, will have been approved, and I 
think what we would need would be safety and immunogenicity 
studies in primates or humans that could be quite rapid. This 
would allow us very rapid protection, single dose, oral, easy 
and inexpensive manufacturing, and the versatility to address a 
very large number of biowarfare agents.
    Now, when I picked cholera I was thinking of bacterial 
biowarfare agents. I know your next question is going to be, 
what about the viral agents. There I believe we can use what we 
call SalmoVec, which is a vector based salmonella typhi, so it 
would be the same story. But I don't want to dilute my message 
on the cholera, because that is still more theoretical. We are 
extrapolating that we can do that.
    But we actually have proof of principle for the bacterial 
antigens, and we are far down the road in development of these 
vaccines. They are extremely inexpensive to make. We use a 
manufacturer called BioSetis in Argentina. But we had bids out 
to many different manufacturers, and I don't really see why, as 
long as they can get themselves to be GMP compliant, one 
couldn't have multiple manufacturers.
    But I'm simply trying to say that there is 21st century 
technology that's available. Although it may seem newer, 
because you've heard of the other vaccines, I believe it could 
be up and running more quickly.
    [The prepared statement of Ms. Ryan follows:]
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    Mr. Shays. Thank you very much. What we're going to do is 
go to Mr. Putnam, and then we'll go to Mr. Sanders, then we'll 
go to Dr. Weldon and to John and myself. I think we'll do 5 
minutes the first round and then go from there. Mr. Putnam. 
Thank you, Mr. Chairman.
    Dr. Wineger, how does, you've spent a good time describing 
your plans for development of smallpox vaccine. How does that 
vaccine differ for a military population that presumably 
doesn't include the elderly or the very young, from the 
civilian vaccine that HHS would be working on?
    Ms. Wineger. In essence, the two candidate vaccines that 
our departments have worked up thus far are indeed very 
similar. The production methods are a little bit different, in 
that we proposed to use what are called nunc cell factories, 
and the HHS approach uses a bioreactor, with cells actually 
grown on beads. Other than that, the viruses are very similar. 
As a matter of fact, we are in continued discussions with the 
Department of Health and Human Services about collapsing the 
two individual programs into one nationwide program, which I 
think would serve both of our purposes very well.
    Mr. Putnam. So are the time lines essentially the same, 
then, for production?
    Ms. Wineger. It's a matter of volume. I think the time 
lines would be very close to being similar, yes. But I would 
like to go back to the point that you made regarding the 
population. The requirements for any of the military products 
that I've mentioned are indeed for a product that could be used 
in normal, healthy adults between the ages of 18 and 65, 
because that's what our military population is. We have not had 
a mandate, nor do we have any expertise in doing the kinds of 
studies that would show that any of these products would be 
safe and immunogenic in a pediatric population, or a geriatric 
population. So that would help to forge an attractive 
partnership for us with our counterparts in HHS.
    Mr. Putnam. Have you done a threat assessment on each of 
the antigens, each of the biological weapons that we talked 
about, plague, smallpox, anthrax, botox, Ebola?
    Ms. Wineger. There are a number of threat assessments that 
have been done. We really on the Defense Intelligence Agency 
and input from the chairman of the Joint Chiefs of Staff to 
provide us with a prioritized matrix. That is a classified 
document, but I believe we can provide it to you. I believe you 
may already have it. If not, we can provide it to the committee 
for your review.
    Mr. Putnam. Thank you.
    Dr. Kingsbury, your testimony, GAO's previous testimony 
about the anthrax vaccine used during the Gulf war and since 
1998 showing the ``significantly greater incidence of both 
local and systemic adverse reactions compared with rates 
reported in product insert,'' how do BioPort and FDA account 
for the higher rates, and will the product insert be changed 
accordingly?
    Ms. Kingsbury. To my knowledge, they don't account for it, 
because they haven't really looked into the question. I would 
assume that when they are approved to produce additional 
vaccine, that they will be addressing the issue of what they 
put in the product insert.
    We've actually been quite surprised that what appears to be 
emerging in the epidemiological literature are some fairly well 
designed studies looking at the impact or the incidence of 
various kinds of illnesses in people who have and have not been 
exposed to the vaccine and haven't been deployed to the Gulf 
region is not being looked at by BioPort, or at least in our 
view, FDA. So I can't really answer your question.
    Mr. Putnam. For anyone on the panel, we have spent the vast 
majority of our discussion talking about specific treatment 
protocols and vaccinations for humans who become exposed or 
infected with these particular diseases. Is any research going 
on, or how far along may be that research if it is going on in 
the public or private sector, with regard to decontaminating 
exposed machinery, buildings and situations of the sort that we 
find ourselves in here in Washington? How far along are we on 
that research? How high technology, or is it a low tech 
approach, with Clorox? What types of things are we doing and 
how effective is that?
    Ms. Wineger. I'll take the first shot at that, and if 
anybody else wants to chime in, they can. From the Department 
of Defense, we obviously had a higher requirement for a number 
of years for successful decontaminating agents. We currently 
have in the system something called DS2, which works very 
effectively. But the problem with it is that it does tend to be 
caustic and it's not environmentally friendly and requires 
large amounts of water.
    So that doesn't make it very applicable.
    Mr. Putnam. Won't work on a computer screen, then?
    Ms. Wineger. Won't work on sensitive electronic equipment, 
doesn't work on people.
    We do have a separate kit, a resin based kit, that can be 
used to decontaminate the skin of individuals, and that is an 
FDA approved item. We are currently evaluating a number of 
different technologies, and one that I'd like to bring to your 
attention was in fact developed by another one of our sister 
agencies, the Department of Energy, at their Sandia Laboratory. 
That's a foam. The foam incorporates in it materials which can 
inactivate chemical and biological agents.
    The attractive feature of this foam is that it's something 
that, for example, firefighters are used to using and they know 
how to employ a particular kind of foam, so that you wouldn't 
have to know in advance whether there were a chemical or 
biological agent there, and it could be a universal type of 
item.
    There's a lot of research ongoing into enzymatic 
decontamination, which is again a more gentle type of approach. 
We have some very promising results with regard to the chemical 
warfare agents, specifically the nerve agents, and have only 
begun looking at some of the biological agents and some of the 
more resistant chemical agents.
    Mr. Putnam. Thank you. My time has expired. I'll followup 
with the rest of you in my next round.
    Mr. Shays. Thank you. Mr. Sanders.
    Mr. Sanders. Thank you, Mr. Chairman.
    My question is a general question, and I'd appreciate 
anyone who wanted to respond to it. It is no secret that the 
pharmaceutical industry is attracted to those areas where they 
can make a lot of money. It's not uncommon, for example, for me 
too drugs to be developed which really aren't very different 
from the original drug, billions of dollars in research and 
marketing going into such important areas as baldness or breast 
enhancement or other types of cosmetic areas.
    In your judgment, how do we draw serious researchers into 
pursuing illnesses and medical problems that you cannot 
necessarily make a whole lot of money out of, or that is 
somewhat unpredictable? In other words, but is absolutely 
necessary? We send the men and women in our armed forces to 
countries and to situations where they need protection. One may 
not necessarily make a lot of money by providing that product. 
One may not necessarily make a lot of money by providing a 
product that we may or may never need. But we need those 
products.
    The U.S. Government obviously has a serious interest in 
developing these products. What in your judgment, I know that 
Mr. Sudovar talked about the need for Federal funds, and I 
don't think anybody in Congress has an objection to that, if it 
is based in an approach which benefits the American people or 
the men and women in our armed forces, and is not designed 
simply to make profits for the company who is doing the work.
    What is, in your judgment, a proper relationship between 
the U.S. Government and the private sector in terms of 
developing products which are not in itself profitable, but 
which are needed by our society? Anyone who wanted to respond.
    Ms. Ryan. Well, I think there are some quite good 
mechanisms in place. One is the SBIRs, the small business 
research grants, and the other are CRADAs, with the Army. But 
what I think the Government needs to do in sending a strong 
message is to support really innovative research. Because as I 
was trying to say, if you've made advances in a very 
fundamental way, often it can be used both to make money and to 
make money in completely different areas. And if the Government 
is wise, it can leverage that technology into areas that are in 
the national interest for quite small additional dollars.
    Mr. Sudovar. If I could comment on that as well, 
Congressman. I think in my testimony I addressed the issue of 
targeted Government funding. By that I really meant just what 
we spoke of a moment ago, and that is, to target that money to 
truly innovative technologies. Because I think one of the 
difficulties is that you can run into the problem of financing 
such endeavors as to bring about me too items which certainly 
are not useful and necessary for the American people.
    I think some of the technologies that we've talked about 
today, particularly in the biotechnology industry, which it 
seems to me is part of the solution to the biotechnology 
problem that we have, which is bioterrorism and biowarfare, is 
to target those moneys at the most promising technologies. I 
think that with respect to profit, I think we all believe, and 
I would hopefully be speaking as well for the large 
pharmaceutical companies, that the profit motivation alone is 
not what we're here for. What we're here for is to collaborate 
with Government at a time of war.
    I think the feelings of even a company like my own and my 
venture capitalists is quite tolerant of us going after areas 
of business that may not be as lucrative as alternative 
therapies in other areas of business. Clearly, there are unmet 
needs out there of vast size that we could go after with our 
unique science. Our own technology alone deals with all blood-
borne infections. So it need not only be bioterrorist 
infections.
    There are such things as asthma, in our case, and other 
allergies, autoimmune diseases, which are unconquered today. 
And I must say, on behalf of the venture capitalists that have 
worked with us, that they have allowed us really to expend and 
invest in biotechnology as it relates to biowarfare. I think 
that there are significant limitations to that.
    Mr. Sanders. Let me interrupt you. They have allowed you. 
We are working here, the purpose of the hearing is to protect 
the American people.
    Mr. Sudovar. Correct.
    Mr. Sanders. Is to protect the men and women in our armed 
forces. We don't need people to allow to. It has to happen.
    So what I am saying is, the function of the U.S. Government 
is to protect the people of this country and our armed forces. 
Whether the venture capitalists allow it or not is not of 
importance to me.
    Mr. Sudovar. In our current system, whether we like it or 
not, that's the way it works.
    Mr. Sanders. Well, that's what I'm asking. I don't like 
that. And I'm suggesting, that's why I want ideas here. What 
happens if the venture capitalists said no? We could get a 
baldness cure. I could use that myself, but there are more 
important issues out there. It's not allow to. We need it. And 
I'm asking questions of how we are going to get it in a 
cooperative--and I'm not saying you don't make a profit off of 
it.
    But if the people of the United States need protection from 
bioterrorism, we don't need the permission of the venture 
capitalists to happen. I want it to happen, we want it to 
happen.
    Mr. Sudovar. I think we've outlined a number of things that 
get in the way of that happening. One is the fact that there 
may be more attractive markets, whether it's venture 
capitalists, whether it's public financing. I think we all know 
with the condition of the economy and with the condition in 
private financing through venture capital, there's not a great 
deal of money available for that. I mean, going public in 
today's environment doesn't really work very well. We haven't 
seen biotech companies go public, and the reason is, there's no 
available funding for it.
    So we do need help from Government if we wish to direct our 
efforts toward bioterrorism and biowarfare. I think that's an 
important point that I've made in my testimony. I think there 
are other issues like the ones that I mentioned. Government has 
a way of being fickle. We could have a disease this month and 
another disease next year and another disease the year after. 
If we continue to follow what Government needs in any 
particular year, we'd never make a profit.
    I mean, we're not not-for-profit, we're just not 
profitable. We do want to make money eventually. I'm not trying 
to be a Fortune 500 company, and we certainly aren't. But I 
think if we're going to use the existing system, it needs to be 
bolstered by Government and we need some help in areas like 
liability protection, longer term contracting, some of the 
things I've submitted in testimony.
    Mr. Shays. Thank you. We're just doing a smaller 5 minute 
round now. Dr. Weldon.
    Dr. Weldon. Thank you, Mr. Chairman. Dr. Wineger, I just 
want to followup on the line of questioning in your responses 
regarding antiseptic agents, or agents that can neutralize 
these biologicals. I've had some inquiries from constituents in 
my district regarding a product called Ecasol. Are you familiar 
with that at all? Evidently it's been--at least I've been 
informed that the Marine Corps has done some work with it. Do 
you have any knowledge of this product at all?
    Ms. Wineger. There's a number of different products of a 
similar nature. I have a limited amount of knowledge about each 
of those, yes.
    Dr. Weldon. I'm just curious, I have constituents asking me 
about it, I thought you might be able to enlighten me a little 
bit. Maybe we can followup with some letters back and forth.
    Ms. Wineger. Sure.
    Dr. Weldon. The line of questioning I'm getting is, some of 
these products, as you mentioned, that neutralize these agents, 
are irritating, corrosive, and this product has been extolled 
by some people as being very effective but not having those 
features. So I'll followup with a letter to you and maybe you 
can get some more information to me.
    Mr. Sudovar, I was very intrigued, you talked about your 
product being one that could be administered to somebody to 
clear toxins out of their system. As I understand the 
pathophysiology of inhaled anthrax, that your product would be 
very useful in that setting, because the agent sort of 
incubates in the lungs and then gets into the lymph nodes and 
then proceeds to cause a tremendous outpouring of toxins into 
the blood stream. People actually die of shock, as I 
understand.
    I'm a little concerned, you say with $50 million you could 
get your product on the market in 2 years, is that right?
    Mr. Sudovar. Yes, the assumptions there are clear. One of 
the assumptions is the regulatory process that we spoke of, 
expedited approval and the availability of only animal data, 
not human data, obviously, for the reasons already discussed.
    We have worked, this is not a new product, this is not 
something we've just come upon, we've been working with 
USAMRIID for well over a year now under contract. The results 
of those studies have been very promising. So we're not all the 
way, but we're quite a ways along. We're at the process where 
we've already screened about 150 antibodies that would indeed 
be directed at the toxin.
    We have very promising results with a small number of those 
antibodies in terms of their efficacy in vitro. Our next step 
would be to go to animal models and then on with USAMRIID. If 
the FDA process were followed that has been proposed in 
regulation but has not been finalized, it would require us then 
to turn the product over to USAMRIID, or a containment facility 
like USAMRIID has, for their experimentation under well defined 
models, non-human primate models, perhaps other species. That 
would be the surrogate for what we would normally do as human 
trials.
    Of course, on the safety side, we'd continue to do as we do 
today with drugs, we'd do safety trials with normal human 
volunteers.
    Dr. Weldon. So what you're saying is, if the normal process 
were pursued, it would take many more years than 2 years?
    Mr. Sudovar. I think there's two issues. One is the issue 
of priority. I think that's something we'd like more guidance 
from Government on, which agents do we want to develop, in what 
order and so on. I think anthrax has been talked about a lot 
today, smallpox certainly. We are focusing on the anthrax issue 
at the moment, although USAMRIID has also talked to us about 
the prospect of moving forward with plague and/or smallpox as 
the next one in line. I think if we were going to truncate the 
program, we're going to need more resources to do it. Because 
at the same time we're developing a drug for lupus, we're 
developing drugs for cancer. We're spread out in a number of 
disease categories.
    Dr. Weldon. I think, Dr. Wineger, you talked about 
developing a new anthrax vaccine by the year 2007?
    Ms. Wineger. Yes.
    Dr. Weldon. Do you think that's an appropriate time line 
for something like this? Do you think we can accelerate it in a 
variety of ways to get a product out quicker than 6 years from 
now? The war might be over in 6 years.
    Ms. Wineger. Exactly. I think we'd all like to identify 
ways to accelerate the schedule without in any way compromising 
the safety.
    Dr. Weldon. I think Dr. Ryan testified on ways to do that 
more quickly. Weren't you essentially saying you could get a 
product out much more rapidly?
    Ms. Ryan. The recombinant PA that we licensed to BioPort, 
we had actually manufactured in 1999 and had provided to 
USAMRIID, Dr. Friedlander. So we know it can be made. But we 
licensed the technology. Although the development of the 
vaccine would be in BioPort's hands, not mine.
    Ms. Wineger. I think you mean DynPort, not BioPort.
    Ms. Ryan. I'm sorry. I do mean DynPort. The ones that I'm 
talking about, again, I don't know what the regulatory pathway 
would be. But it's a matter of months to do the manufacturing, 
because we've done it.
    So I think the time to approval and use by the American 
public would depend on what testing would have to be done.
    Ms. Wineger. If I could just elaborate on that, for both 
our recombinant anthrax vaccine and the next generation 
smallpox vaccine also, I don't think that production is the 
limiting factor, at least not at the moment.
    I think that indeed, the testing, and if you assume that we 
have to do the careful scrutiny that we know will be required 
and that we certainly support and intend to do, of a phase one 
study with a limited number of people, maybe 25 or 30 people, 
then take some time to evaluate that data, meet with the FDA to 
discuss that, and then move into a phase two type of study, 
which would enroll larger numbers of volunteers, and would be 
doing such things as optimizing the dose and measuring whatever 
types of response we can measure, whether it's a toxin 
neutralization or a virus neutralization for the smallpox 
vaccine, all those types of studies take months, if not years, 
to do. I think that's where we would really have to concentrate 
on shortening the schedule.
    Dr. Weldon. My time has expired. Thank you, Mr. Chairman.
    Mr. Shays. Mr. Tierney.
    Mr. Tierney. Thank you.
    I think, Ms. Kingsbury, you might be the proper one to 
address this question. How does the Federal Government 
actually, or are we actually identifying and making threat risk 
assessments, so that we can say to manufacturers, this is the 
priority of remedies that we need, or are we doing it 
differently in every agency? I heard Dr. Wineger earlier say 
that she takes her information from Defense Intelligence, and 
they have a matrix. I know the FBI bases theirs, or I believe 
the FBI bases theirs on what terrorists would likely use. And 
the CDC bases theirs on what likely would have the most impact.
    So we seem to be coming at it from different angles. Is 
there any cogent way that the Federal Government is approaching 
this, or is there anything in the works?
    Ms. Kingsbury. We haven't actually looked very much into 
that, although we did get briefings last week that would 
suggest that there is finally coming together better 
coordination across the intelligence agencies and the law 
enforcement agencies to try to do that. But we haven't actually 
looked at the results of that work.
    Mr. Tierney. Do you know if there is a process that has 
been in place, and how formal is it?
    Ms. Kingsbury. We were told there are daily meetings where 
all the right people are in the room. I have, at this point in 
the aftermath of September 11th, I suspect it's probably 
working better than it ever has before. But I don't know that 
for a fact.
    Mr. Tierney. Where would we get that information? What 
would be our best source on that? Would it be back to the 
Secretary of Health?
    Ms. Kingsbury. I don't know if it would be the Secretary of 
Health or the Secretary of Defense.
    Mr. Tierney. OK. We'll pursue that.
    The other thing I'm not real clear on is, if we have no way 
of testing any of these new products that may come out on 
humans, effectively what we're saying is that we're going to 
have an approved product, if that part of it is set aside, that 
we'll never know if it's going to work or not, we'll never have 
any real confidence in its reliability until there's a crisis 
and we use it and see what the results are. Is that pretty much 
what the situation is?
    Ms. Ryan. I think that we can't ever do the efficacy trial 
with a life challenge or in an endemic area. But I do think it 
can be tested in humans for tolerability, that actually giving 
the vaccine doesn't make volunteers, for example, sick. And for 
measuring a titre, which is a very good surrogate for 
protective immunity.
    So one would have to use a surrogate marker that's served 
very well in vaccines over the years. In fact, that's how you 
test if somebody is protected, is do they have the right level 
of antibodies. So you wouldn't be able to do the kind of trial 
that you are nowadays required to do in peace time that take 6, 
7, 8 years. But I do think you could test it in humans.
    Mr. Tierney. So in that perhaps it didn't do any harm, but 
we wouldn't know for sure it was going to work?
    Ms. Ryan. Well, you'd have a good surrogate.
    Mr. Tierney. No certainty but a probability.
    Mr. Ryan. Dr. Fauci talked about take. I'm talking about a 
blood test that gave you a measure of the antibody response.
    Mr. Sudovar. I was going to pick up on that same thing. I 
think Dr. Fauci described it this morning. What you can do, in 
our particular technology, non-human primates, because their 
red blood cells are virtually identical to ours, they circulate 
and dispense with bacteria, toxins and viruses similarly to how 
humans do, are an excellent surrogate measure for what will 
happen in humans. So it's the greatest certainty we can get 
without exposing humans to anthrax and then trying to fix is.
    I think the other thing is, I believe, it's part of the 
regulations that the FDA has advanced in final stage for 
comment, but has not yet promulgated, they've indicated the 
desire for us, on a post-marketing surveillance basis, should 
there be exposure for some reason or another to anthrax, that 
we be required to go in, assess and evaluate the utility, 
really, of the safety and efficacy of our compounds as they're 
put into use. But I think the key here, as was just suggested, 
is that we certainly will know that they're safe compounds or 
what the shortcomings are if they're not. We'll also know, I 
think, with a high degree of certainty, particularly using it 
on human primates in my technology, they're highly predictive 
of human behavior.
    Ms. Ryan. I'm just reminded that the annual flu shot is 
tested the way I was suggesting. In principle, we know what's 
in a flu shot and we know that it's safe and has been 
effective. But the exact mix each year does not go through full 
blown human clinical trials. It simply is tested the way I'm 
suggesting.
    Mr. Tierney. Thank you.
    Getting back to you, Mr. Sudovar, and the questions my 
colleague was raising, you indicated that you think your 
industry needs research and development money from the Federal 
Government. You think they need long term Government contracts. 
You think they need liability protection, support from security 
measures and FDA support in expediting all the research 
process. At that point, what risk would any of your venture 
capitalists actually incur? [Laughter.]
    Mr. Sudovar. Well, there's a risk of pricing issues, such 
as the ones that were talked about this morning. I think 
there's significant risk in whether or not the technology works 
at all. We have dedicated, I want to make it clear for the 
record, and for the group here, that we have not taken a single 
dollar of Government funding, and this technology is quite a 
ways along. And that has been with a great deal of risk.
    Mr. Tierney. I guess I don't doubt that. I'm just saying, 
when I look at all of that, I'm thinking, if the Government is 
going to do all of that for any industry or any company or 
whatever, ought not there be more of a partnership aspect going 
here than just somebody that ponies up the money and provides 
for protection against the liability?
    Or on the other hand, maybe this ought to be the type of an 
entity that is Government operated by commercially owned, so 
maybe if the Government comes in and then just contracts out 
some of the work, you make your profit by performing the task, 
as opposed to having this endless stream of potential profits 
that might lead us in different directions. But you make a fair 
profit on it.
    The Government, on the other hand, gets some return for its 
investment and as can be anticipated, you might find out that 
somebody does suffer damages from something, and when they can 
look, and the Government has generally been in a position to 
help them out, it's not been something the Government has 
turned their backs on. So there's going to be liability 
incurred somewhere, probably by the Government if everybody 
else is immunized from it.
    Mr. Sudovar. I think the issue is one of availability of 
funds to us. I think we probably could take this offline, I'm 
not sure that it's appropriate to discuss here, the whole issue 
of our patent system and so on. We rely heavily on intellectual 
property as the basis and foundation for business in this 
country. I think to begin to tamper with that brings us down a 
dangerous road that I certainly don't care to go down. I think 
other members of my industry would support me in that 
contention.
    Mr. Tierney. My time is up. I'll get back with you.
    Mr. Shays. When we do the next round, we'll do a 10 minute 
each member. Putting the three panels together means that we 
don't focus as much sometimes on the same issue.
    I'm just going to use some of my time to say, I happen to 
be very grateful that we have a system that encourages the 
private sector to get in, to develop a product. Some of the 
products that we now want to have generic drugs for, we 
wouldn't even have had those products to copy and have the 
generic had we not had people investing.
    So for instance, when I went out to California, there's a 
company that's invested close to $800 million to $900 million 
to develop a drug for Alzheimer's. And they don't know if it's 
going to work. And then they lose all of it. So there's got to 
be somehow a happy compromise in our system to enable us to 
accomplish what you all want to do, but still get that 
inventiveness, that ingenuity out there that creates these 
drugs that have been very helpful in our country.
    I get the sense from GAO that the bottom line of your point 
is, that good manufacturing practice compliance is essential to 
the production of good vaccines. You want the good production 
practices, and then you're going to end up with a better 
vaccine. And you said that post-marketing surveillance is 
critical for bio-defense vaccines as well.
    When I heard you, I basically, I'm listening to a company 
that arbitrarily changed its fermenters and its filter. That 
strikes me as being, my trying to build a house before I had 
the permits, and then being pretty unhappy when they say I 
can't have the house. Is this a common practice for a company 
to do? Is the culture different based on different kinds of--I 
get the feeling, for instance, in vaccines, maybe this isn't 
considered unusual. Is it?
    Ms. Kingsbury. When we were going about this work, we had 
hoped to be able to find out, find some actual information 
about that. I think Dr. Melling might be able to comment a 
little bit about that.
    Mr. Shays. Let's have him do that.
    Ms. Kingsbury. But maybe not. There are proprietary issues 
in our going to talk to how other companies deal with the FDA 
that kind of didn't allow us to go down that path. We are going 
to be looking at any regulatory entity that there is a 
regulation on the books that something be reported to FDA, and 
it's not reported to FDA, and FDA doesn't have the processes in 
place to notice that it wasn't reported strikes me as a not 
very rigorous process.
    Mr. Shays. And it doesn't breed confidence in the system. I 
mean, you have a sole source producer, unfortunately, BioPort 
is an example of the kind of combination you wonder about. It's 
gotten so much Federal dollars, and I look at it and say, good 
grief, I don't want that to be my model.
    But in the end, they arbitrarily changed the fermenting 
system and the filtering system. And they did not report it. 
And there is an assumption that somehow they were improving the 
process. But they were changing the process that they had 
gotten licensed for. Isn't that correct?
    Dr. Wineger. If I might, I'd like to interject there. And 
perhaps it's a matter of definition. The original fermenter 
that was in place at the Michigan Department of Public Health 
when the vaccine was licensed was indeed a glass-lined 
fermenter made by a company called Fodler. In about the 1990 
timeframe, when I was working with the Army and we wanted to 
find ways to accelerate the amount of vaccine that the 
corporation could produce, the obvious choice was to put in 
additional production lines, if you will.
    Fodler was no longer in business, and no longer made 
fermenters. The first choice would have been to buy an 
additional fermenter exactly like the one they had, to thereby 
minimize the changes. That was not possible. So they did a lot 
of rigorous investigation to get one the same size and shape, 
because fermenters come as tall skinny ones and short fat ones 
and different kinds of bacteria like to grow in different ways 
and all those types of things.
    So we, the Department of Defense, worked with Michigan 
Department of Public Health to purchase, install and validate 
the fermenters in 1990. I believe, and correct me if I'm wrong 
here, the original paperwork to the FDA on the change of those 
fresh fermenters was filed in a timely fashion, and it took the 
FDA 3 years to approve those fermenters.
    Mr. Shays. So in that case they were notified of the 
fermenter--the filters?
    Ms. Kingsbury. The filters they were not, right. The 
filters are different.
    Mr. Shays. Would anybody on your staff care to add 
anything?
    Mr. Melling. I think that, of course we're looking 10 years 
back in time here. Maybe if we can take a positive lesson from 
this, which is, these are a group of products, biodefense 
vaccines, that have been orphans of the storm for probably 
going on 30 or more years, which is I think why we're sitting 
here today with really only one vaccine currently being 
manufactured that is licensed, a range of other requirements.
    And Congressman, I think you asked the question earlier, 
what could be done to encourage more people to participate in 
what is a worthwhile and essential activity. I think it comes 
down to, this is an area actually that needs to be appreciated. 
I, like Dr. Johnson-Wineger, she and I have known each other 
for 30 some years. We have again seen occasionally the orphan 
come out into the sunlight. It happened during the Gulf war 
when there was a vaccine potential biological weapons issue. 
And then it all went away again.
    This has happened from time to time. And as you've heard 
today, it's very clear that vaccine development is a long term 
issue. You don't develop a vaccine in 6 months, 1 year, or 2 
years. So what is needed is adequate funding. It's continuity 
of support, and I think it's a message, which I think now is 
going out, that this is indeed intellectually challenging, 
scientifically worthwhile, and in fact, something that is a 
humanitarian cause. I think those are the things that will 
attract people to work in this field.
    But again, over this long period, I know when I was in the 
U.K. and here, from time to time it was extremely difficult to 
even keep a minimum program running. People didn't reach----
    Mr. Shays. Jack, I need to cut you off here. Let me just 
say to the Members, we're going to 10 minutes. Bernie, if you--
--
    Mr. Sanders. Not now.
    Mr. Shays. I'm going to just have a few more questions, 
then.
    Is vaccine production viewed differently by the FDA as 
other types of drugs? You're nodding your head, could you 
respond? You were trying to give us the message that somehow it 
could be, that somehow the requirements could be different. I 
need to understand why.
    Ms. Ryan. The requirements are really onerous. You're 
absolutely right about phase one, phase two, and phase three.
    Mr. Shays. But they were designed to protect people. You 
wanted to have a small group of people first and know it 
wouldn't harm you, and you want to begin to know if it is 
effective, and then you expand the group and you expand it. So 
when you say onerous, I thought they were there for a reason.
    Ms. Ryan. That is why they're there, but I think things 
have become somewhat subverted. One of the programs we have is 
for a rotavirus vaccine for inoculating babies against 
rotavirus diarrhea. It's partnered with Glaxxo SmithKline. The 
phase three trials involve 50,000 infants, and may go as high 
as 100,000. Merck has a similar trial that's now 60,000 
infants, may also go to 100,000.
    Mr. Shays. Are you suggesting a third phase is including 
more than----
    Ms. Ryan. But the reason, and I understand why it happened. 
But understanding it doesn't sort of make it right. A previous 
rotavirus vaccine was withdrawn, because there was a very, very 
rare side effect. And so the agency has now become extremely 
conservative and is asking for longer, larger trials, which on 
the face of it, is exactly the right response.
    But in fact, the same number of children are being exposed, 
and the risk of finding those very, very rare side effects is 
no better in the trial than it would be in post-marketing 
surveillance. And were it not for the fact that----
    Mr. Shays. We understand. Just so I'm clear.
    Ms. Ryan [continuing]. I have a partner like Glaxxo, I 
couldn't do it.
    Mr. Shays. I understand. Let me just interrupt you. So 
you're suggesting that the post-marketing, in a sense, be 
almost the trial, the third phase?
    Ms. Ryan. Well, that it go out there into the real 
population, so it's not just being tested in academic 
hospitals, the real exposure and the real incidence of very 
rare side effects would be monitored. And if they are 
dangerous, it can be withdrawn.
    Mr. Shays. Do you all agree that post-marketing is an 
important element? I should be fair to you, Dr. Wineger, it 
leads me to the question, that's where I think the military has 
its biggest breakdown. It seems to me, once they've got it 
approved, or once they've got a tacit acknowledgement they can 
use a pharmaceutical product, there is no post-marketing, there 
is no sense of how it's impacting our troops. I guess I want to 
know, do you both believe that post-marketing is important?
    Ms. Ryan. I believe it is. And I think that vaccines really 
should be tested the way drugs are. And some of these enormous 
trials mean that only the large pharmaceutical companies can 
develop them.
    Mr. Shays. You just said something that I'm going to expose 
my ignorance. The way drugs are, in other words, you're 
suggesting you don't need this larger market, larger testing if 
it's not vaccines?
    Ms. Ryan. A large phase three clinical trial for a drug is 
3,000 to 5,000 patients. Some of these vaccine trials, where 
every second child in Finland is being part of a vaccine trial 
doesn't really make sense to me.
    Mr. Shays. Any other comments? Dr. Wineger, do you want to 
just comment about the post--our committee has basically had 
too much experience with, I'll speak for myself, I feel that 
the Department of Defense lacks credibility in this particular 
area. Once they've got approval, it's all steam ahead. And 
there isn't proper recordkeeping, there isn't proper post-
marketing analysis of what's happened. How can we in this 
committee have the confidence that's going to change?
    Ms. Wineger. Well, first of all, I'd like to differentiate, 
if I could, between the responsibilities of the manufacturer 
and the responsibilities of, in this case, the user. I believe 
that the comments that were provided earlier were directed 
toward the responsibility of a manufacturer to conduct post-
marketing surveillance.
    Mr. Shays. I think that's different. BioPort is so close to 
being part of the Defense company. It's gotten its money, it's 
been basically pushed by the DOD, it's been overseen by the 
DOD, it's been funded by the DOD. So I just kind of feel you're 
both the same.
    Ms. Wineger. Well, I would agree that the anthrax vaccine 
immunization program that the Department of Defense has adopted 
is a different situation than most others. But I would remind 
you that the Department of Defense purchases and uses many 
other vaccines and many other drugs. We do not have any type of 
responsibility for post-marketing surveillance of those 
products. So if indeed you want to characterize the 
manufacturer, BioPort, and the Department's anthrax vaccine 
program as unique and different from all others, then I'd be 
happy to provide some comments on that.
    My point was that it is not traditionally the consumer, the 
user's responsibility to do that post-marketing survey.
    Mr. Shays. The problem is, though, when a company has to 
analyze what's happened to DOD employees, they don't have their 
records. It's almost disingenuous to even suggest that there 
can be that followup, because the records that are kept by the 
military are confidential, they don't have access to them. And 
in many cases, the records are so poorly kept. You're not 
suggesting the manufacturers be out in the battlefield, and in 
your hospitals. Maybe we should. Is that what it's going to 
take?
    Ms. Wineger. What I'm suggesting is that there are a number 
of mechanisms in place for individual reporting and for 
monitoring the side effects of the vaccine. While the 
recordkeeping may not be perfect, certainly in a battlefield 
situation, indeed, many of the immunizations are given in U.S. 
locations. As far as I'm aware, there's no prohibition from the 
manufacturer or the FDA or any other body from coming in and 
inspecting those records.
    Mr. Shays. The problem is, though, and I won't belabor it, 
is that during the Gulf war, we don't know, of the military 
personnel who claim Gulf war illnesses, there was no 
recordkeeping of when they were given the drugs, when they were 
given vaccines, when they were given shots, the cocktail effect 
and so on. I don't want to open up with Bernie on this one. 
[Laughter.]
    But the bottom line is, there are some big challenges here.
    Ms. Wineger. I appreciate that.
    Mr. Shays. I would love to just ask if, particularly those 
who had worked on the study with you, if there's any question 
we should have asked you that you want to respond to, any 
comment you would like to make as well.
    Ms. Heinrich. I was just going to comment that it's very 
hard to do really good post-marketing surveillance. FDA is very 
much in favor of post-marketing surveillance in many instances, 
and in some have asked for this and have tried to require it. 
But it's very, very difficult to do after the actual approval 
has been made on a particular drug or vaccine.
    In terms of your good manufacturing practices and 
differences between vaccines and drugs, those manufacturing 
practices are very consistent. The other thing that I wanted to 
add is that anthrax isn't the only vaccine that has suffered 
from problems with their good manufacturing practices. Last 
year when we had the vaccine shortage for flu, it was because 
there were at least two producers that were having difficulty 
with their manufacturing practices. So it's something that the 
FDA and all of us involved in oversight, I think, have to be 
rigorous about.
    Mr. Shays. Anyone else?
    I'll tell you my concern in closing. My concern is that 
we're going to have two standards. We're going to have one 
standard for civilians and the vaccines they receive, we're 
going to have another standard for the military. I'm just 
concerned that the population is different, the testing may end 
up being different. And I'm hopeful that we're going to 
reanalyze this and make sure there's one standard. We need to 
speed up the process, but make sure that it's ultimately going 
to achieve its objective of providing safe products that also 
are very effective.
    Does any other Member want to say anything?
    Thank you very much, and we will adjourn this hearing.
    [Whereupon, at 2:15 p.m., the subcommittee was adjourned, 
to reconvene at the call of the Chair.]

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