[House Hearing, 107 Congress]
[From the U.S. Government Publishing 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
_____________
U. S. GOVERNMENT PRINTING OFFICE
81-780 WASHINGTON : 2002
___________________________________________________________________________
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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
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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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