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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

(II)

COMMITTEE ON GOVERNMENT REFORM

DAN BURTON, Indiana, Chairman

BENJAMIN A. GILMAN, New York

CONSTANCE A. MORELLA, Maryland

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

STEPHEN HORN, California

JOHN L. MICA, Florida

THOMAS M. DAVIS, Virginia

MARK E. SOUDER, Indiana

STEVEN C. LATOURETTE, Ohio

BOB BARR, Georgia

DAN MILLER, Florida

DOUG OSE, California

RON LEWIS, Kentucky

JO ANN DAVIS, Virginia

TODD RUSSELL PLATTS, Pennsylvania

DAVE WELDON, Florida

CHRIS CANNON, Utah

ADAM H. PUTNAM, Florida

C.L. ‘‘BUTCH’’ OTTER, Idaho

EDWARD L. SCHROCK, Virginia

JOHN J. DUNCAN, JR., Tennessee

——— ———

HENRY A. WAXMAN, California

TOM LANTOS, California

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

PATSY T. MINK, Hawaii

CAROLYN B. MALONEY, New York

ELEANOR HOLMES NORTON, Washington,

DC

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

ROD R. BLAGOJEVICH, Illinois

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

JIM TURNER, Texas

THOMAS H. ALLEN, Maine

JANICE D. SCHAKOWSKY, Illinois

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

——— ———

———

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

BENJAMIN A. GILMAN, New York

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

STEVEN C. LATOURETTE, Ohio

RON LEWIS, Kentucky

TODD RUSSELL PLATTS, Pennsylvania

DAVE WELDON, Florida

C.L. ‘‘BUTCH’’ OTTER, Idaho

EDWARD L. SCHROCK, Virginia

DENNIS J. KUCINICH, Ohio

BERNARD SANDERS, Vermont

THOMAS H. ALLEN, Maine

TOM LANTOS, California

JOHN F. TIERNEY, Massachusetts

JANICE D. SCHAKOWSKY, Illinois

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

——— ———

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

(III)

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

(1)

BIOLOGICAL WARFARE DEFENSE VACCINE

RESEARCH AND DEVELOPMENT PROGRAM

TUESDAY, OCTOBER 23, 2001

HOUSE OF REPRESENTATIVES,

SUBCOMMITTEE ON NATIONAL SECURITY, VETERANS

AFFAIRS AND INTERNATIONAL RELATIONS,

COMMITTEE ON GOVERNMENT REFORM,

Washington, DC.

The subcommittee met, pursuant to notice, at 10 a.m., in the Hubert H. Humphrey Building, Hon. Christopher Shays (chairman of

the subcommittee) presiding.

Present: Representatives Shays, Sanders, Putnam, Lantos,

Kucinich, Tierney, and Weldon.

Staff present: Lawrence Halloran, staff director and counsel;

Robert Newman, Kristine McElroy, and Thomas Costa, professional

staff members; Nicholas Palarino, senior policy advisor; Jason

Chung, clerk; David Rapallo, minority counsel; and Earley Green,

minority assistant clerk.

Mr. SHAYS. I’d like to call this hearing to order, and to welcome

our witnesses and our guests.

On behalf of the entire subcommittee I want to thank Secretary

Thompson for enabling us to hold this field hearing in the Humphrey Building this morning. Through their unhesitating willingness to help us go forward, despite continued closure of the House

Office buildings, the Secretary and his extraordinary staff demonstrating once again as they have so many times since September

11th their determination to conduct the Nation’s business despite

enormous challenges.

We convene this hearing in an unaccustomed place to discuss an

unprecedented need for vaccines to protect against the most unnatural outbreaks of disease imaginable, biological terrorism. In

reaching beyond familiar places and customary ways of doing business, we heed the wise counsel of Abraham Lincoln who advised a

Nation facing the terror of civil war that, ‘‘The dogmas of the quiet

past are inadequate to the stormy present. The occasion is piled

high with difficulty and we must rise with the occasion. As our case

is new, so we must think anew and act anew. We must disenthrall

ourselves and then we shall save our country.’’ Thinking anew requires confronting hard, new realities. There is

no absolute immunity to biological attack. Nature’s varied and virulent arsenal of pathogens will always outnumber and out-gun our

immunological defenses. The prospect of genetically engineered organisms only compounds our peril.

2

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:]

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4

5

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 reexamining 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

6

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.

7

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.

8

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

9

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

10

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 FlorVerDate 11-MAY-2000 09:54 Oct 28, 2002 Jkt 000000 PO 00000 Frm 00014 Fmt 6633 Sfmt 6633 C:\DOCS\81780.TXT HGOVREF1 PsN: HGOVREF1
11

ida 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 overVerDate 11-MAY-2000 09:54 Oct 28, 2002 Jkt 000000 PO 00000 Frm 00015 Fmt 6633 Sfmt 6633 C:\DOCS\81780.TXT HGOVREF1 PsN: HGOVREF1
12

whelmed 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 na- tional 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

13

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.

14

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.

33

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.

34

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.

35

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.

36

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.

37

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.

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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?

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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.

40

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.

41

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 pack- age, $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.

42

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 email 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.

43

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

44

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

45

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

46

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.

47

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 inVerDate 11-MAY-2000 09:54 Oct 28, 2002 Jkt 000000 PO 00000 Frm 00051 Fmt 6633 Sfmt 6633 C:\DOCS\81780.TXT HGOVREF1 PsN: HGOVREF1
48

dicated 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.

49

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?

50

[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

51

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 achievVerDate 11-MAY-2000 09:54 Oct 28, 2002 Jkt 000000 PO 00000 Frm 00055 Fmt 6633 Sfmt 6633 C:\DOCS\81780.TXT HGOVREF1 PsN: HGOVREF1
52

ing 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. Gov- ernment, 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

53

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.

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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.

55

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 preSeptember 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

56

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?

57

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

58

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

59

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.

60

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 startVerDate 11-MAY-2000 09:54 Oct 28, 2002 Jkt 000000 PO 00000 Frm 00064 Fmt 6633 Sfmt 6633 C:\DOCS\81780.TXT HGOVREF1 PsN: HGOVREF1
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ed 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

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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 21⁄2 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.

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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

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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

65

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.

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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.

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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.

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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.

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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 multiagent 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

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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.

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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

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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

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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 bacVerDate 11-MAY-2000 09:54 Oct 28, 2002 Jkt 000000 PO 00000 Frm 00110 Fmt 6633 Sfmt 6633 C:\DOCS\81780.TXT HGOVREF1 PsN: HGOVREF1
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terial 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

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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.

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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

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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

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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

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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.

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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

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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.

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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?

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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

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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.

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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——

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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

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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 ultiVerDate 11-MAY-2000 09:54 Oct 28, 2002 Jkt 000000 PO 00000 Frm 00132 Fmt 6633 Sfmt 6633 C:\DOCS\81780.TXT HGOVREF1 PsN: HGOVREF1
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mately 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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