U.S. GOVERNMENT PRINTING OFFICE

WASHINGTON : 

For sale by the Superintendent of Documents, U.S. Government Printing Office

Internet: bookstore.gpo.gov Phone: toll free (866) 512–1800; DC area (202) 512–1800

Fax: (202) 512–2250 Mail: Stop SSOP, Washington, DC 20402–0001

93–723 PDF 2004

A REVIEW OF THIS YEAR’S FLU SEASON: DOES

OUR PUBLIC HEALTH SYSTEM NEED A SHOT IN

THE ARM?

HEARING

BEFORE THE

COMMITTEE ON

GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED EIGHTH CONGRESS

SECOND SESSION

FEBRUARY 12, 2004

Serial No. 108–143

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

TOM DAVIS, Virginia, Chairman

DAN BURTON, Indiana

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

MARK E. SOUDER, Indiana

STEVEN C. LATOURETTE, Ohio

DOUG OSE, California

RON LEWIS, Kentucky

JO ANN DAVIS, Virginia

TODD RUSSELL PLATTS, Pennsylvania

CHRIS CANNON, Utah

ADAM H. PUTNAM, Florida

EDWARD L. SCHROCK, Virginia

JOHN J. DUNCAN, JR., Tennessee

NATHAN DEAL, Georgia

CANDICE S. MILLER, Michigan

TIM MURPHY, Pennsylvania

MICHAEL R. TURNER, Ohio

JOHN R. CARTER, Texas

MARSHA BLACKBURN, Tennessee

——— ———

——— ———

HENRY A. WAXMAN, California

TOM LANTOS, California

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

CAROLYN B. MALONEY, New York

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

STEPHEN F. LYNCH, Massachusetts

CHRIS VAN HOLLEN, Maryland

LINDA T. SANCHEZ, California

C.A. ‘‘DUTCH’’ RUPPERSBERGER, Maryland

ELEANOR HOLMES NORTON, District of

Columbia

JIM COOPER, Tennessee

——— ———

———

BERNARD SANDERS, Vermont

(Independent)

MELISSA WOJCIAK, Staff Director

DAVID MARIN, Deputy Staff Director/Communications Director

ROB BORDEN, Parliamentarian

TERESA AUSTIN, Chief Clerk

PHIL BARNETT, Minority Chief of Staff/Chief Counsel

(III)

C O N T E N T S

Page

Hearing held on February 12, 2004 ....................................................................... 1

Statement of:

Gerberding, Dr. Julie, Director, Centers for Disease Control and Prevention; Dr. Anthony S. Fauci, Director, National Institute of Allergy and

Infectious Diseases; and Dr. Janet Heinrich, Director, Public Health

Issues, General Accounting Office ............................................................... 12

Stroube, Dr. Robert, Virginia State health commissioner, Association of

State and Territorial Health Officials; Karen N. Miller, president, National Association of Counties, commissioner, Boone County, MO, accompanied by Dr. Susan Allan, health director, Arlington County Public Health Division, Department of Human Services; Howard Pien,

president and chief executive officer, Chiron Corp.; Dr. James Young,

president, research and development, MedImmune, Inc.; and Dr. Shelley A. Hearne, executive director, Trust for America’s Health ................. 87

Letters, statements, etc., submitted for the record by:

Cummings, Hon. Elijah E., a Representative in Congress from the State

of Maryland, prepared statement of ............................................................ 157

Davis, Chairman Tom, a Representative in Congress from the State of

Virginia, prepared statement of ................................................................... 3

Deal, Hon. Nathan, a Representative in Congress from the State of Georgia, prepared statement of ........................................................................... 160

Fauci, Dr. Anthony S., Director, National Institute of Allergy and Infectious Diseases, prepared statement of ........................................................ 42

Gerberding, Dr. Julie, Director, Centers for Disease Control and Prevention, prepared statement of .......................................................................... 15

Hearne, Dr. Shelley A., executive director, Trust for America’s Health,

prepared statement of ................................................................................... 141

Heinrich, Dr. Janet, Director, Public Health Issues, General Accounting

Office, prepared statement of ....................................................................... 62

Miller, Karen N., president, National Association of Counties, commissioner, Boone County, MO, prepared statement of .................................... 109

Pien, Howard, president and chief executive officer, Chiron Corp., prepared statement of ........................................................................................ 115

Stroube, Dr. Robert, Virginia State health commissioner, Association of

State and Territorial Health Officials, prepared statement of ................. 90

Waxman, Hon. Henry A., a Representative in Congress from the State

of California, prepared statement of ........................................................... 7

Young, Dr. James, president, research and development, MedImmune,

Inc., prepared statement of .......................................................................... 133

(1)

A REVIEW OF THIS YEAR’S FLU SEASON:

DOES OUR PUBLIC HEALTH SYSTEM NEED

A SHOT IN THE ARM?

THURSDAY, FEBRUARY 12, 2004

HOUSE OF REPRESENTATIVES,

COMMITTEE ON GOVERNMENT REFORM,

Washington, DC.

The committee met, pursuant to notice, at 10:19 a.m., in room

2154, Rayburn House Office Building, Hon. Tom Davis (chairman

of the committee) presiding.

Present: Representatives Tom Davis, Duncan, Miller, Waxman,

Tierney, Van Hollen, and Norton.

Staff present: Melissa Wojciak, staff director; David Marin, deputy staff director/communications director; Ellen Brown, legislative

director and senior policy counsel; Drew Crockett, deputy director

of communications; Susie Schulte, professional staff member; Teresa Austin, chief clerk; Brien Beattie, deputy clerk; Phil Barnett,

minority staff director; Anna Laitin, minority communications &

policy assistant; Sarah Despres, minority counsel; Josh Sharfstein,

minority professional staff member; Earley Green, minority chief

clerk; Jean Gosa, minority assistant clerk; and Cecelia Morton, minority office manager.

Chairman TOM DAVIS. Good morning. A quorum being present,

the committee will come to order. I want to welcome everybody to

today’s oversight hearing on our public health system’s response

capabilities to manage a pandemic of contagious disease.

This year’s flu season has raised the urgent question of whether

our country is prepared to deal with a pandemic, be it a naturally

occurring pandemic or one that results from a bioterrorist attack.

Today we will examine what actions and planning procedures have

been taken by Federal, State and local health officials to handle

this year’s flu season and other communicable disease outbreaks.

Only then can we determine the potential needs of government and

health officials to respond effectively to all types of contagious disease threats.

Although this year’s flu season was not a large-scale epidemic,

several thousand people have died from complications of the flu.

Additionally, several thousand people were unable to be vaccinated

due to limitations of the vaccine supply. While the flu virus is airborne and spreads easily, vaccination significantly decreases the

risk of illness and helps prevent the spread of the flu virus.

Preparing for the annual flu season highlights the importance of

strong cooperation between different health agencies and private

2

sector companies at all levels. We need to ensure that adequate

production capacities for flu vaccine manufacturers exist in order

to avoid a vaccine shortage next year. Once a flu pandemic is identified, it is important to determine what the public and private sector capabilities are to produce, distribute and administer

diagnostics, vaccines, and drugs for this problem. This year’s vaccine shortage begs the question: ‘‘Are new mechanisms and incentives needed to guarantee that effective and safe drugs, vaccines,

and diagnostics can be produced as quickly as possible?’’

The current influenza season has challenged our public health

system’s capabilities and provides us with a chance to evaluate existing procedures and safeguards. The Public Health Security and

Bioterrorism Preparedness in Response Act of 2001 provided substantial new fundings for States, localities, and hospitals to boost

preparedness to respond to a highly contagious disease, including

influenza. The legislation included new grant programs, educational efforts, State planning requirements, expansion of Federal

disaster teams, pandemic preparedness resources, and new authority to deal with public health emergencies. We will take a look at

how these programs are being implemented and if funds are being

allocated properly.

I understand some of our witnesses this morning will express

concerns about the actual preparedness levels and Federal funding

for States and localities. I look forward to a constructive dialog on

those concerns. I know we all share the same goal at the end of

the day: a public health system prepared to deal with an outbreak

of a deadly and contagious disease.

The threat of a public health disaster emphasizes the need for

planning and practice. The quicker the health community responds,

the quicker a prevention and control strategy can be developed,

and appropriate treatments can be identified. This hearing will recognize if any deficiencies in coordination, communication, and capacities exist and will facilitate discussions of how to work toward

improvements necessary for more effective preparedness. In order

to be adequately prepared, we should always be expecting the unexpected.

We have a great selection of witnesses today. I want to thank all

of them for appearing with us, and I look forward to their testimony.

[The prepared statement of Chairman Tom Davis follows:]

3

4

5

Chairman TOM DAVIS. I will now yield to Mr. Waxman for an

opening statement.

But let me say before Mr. Waxman, we have the D.C. Young Suffragists here to watch the hearing today, over here to our side, and

let me thank all of our young people here today. Thank you for

being with us.

Mr. WAXMAN. Thank you, Mr. Chairman. Let me start by thanking you for calling this hearing today. I especially appreciate your

interest in public health at this relatively quiet moment—before

the next crisis comes.

Public health issues either dominate the news—think of SARS

and anthrax and monkeypox—or it is woefully ignored. Hearings

like this one provide an important opportunity to take a step back

and assess how far we have come in supporting our public health

system and what more needs to be done.

We know that there will be another public health crisis, and

many experts believe that this next crisis could be a global flu pandemic. In a regular flu season, about 36,000 Americans die from

the flu. A pandemic could be far worse. The flu pandemic of 1918

cost millions of lives around the world, including about 500,000 in

the United States. The next flu pandemic could be right around the

corner. If the ‘‘bird flu’’ virus in Asia acquires the capacity to

spread rapidly from human to human, we could be facing a pandemic.

This year’s flu season exposed some of the weaknesses in our

public health system. As reports of deaths among children mounted, demand for flu shots spiked. Because the demand exceeded supply, the country faced a potentially very dangerous vaccine shortage. This frightening situation led many to ask why the supply was

inadequate to meet the demand.

The answer is revealing. Public health authorities recommend

that about 185 million Americans get the flu vaccine every year.

However, vaccine manufacturers make only about half this amount

because they estimate, correctly, that only a fraction of those who

should get the vaccine will actually do so.

The implications of this situation are sobering. Without an increase in demand, companies may not develop and sustain the capacity to produce sufficient quantities of a life-saving vaccine

against a pandemic strain.

The solution is not to wait for a pandemic to hit. We need to increase the use of the flu vaccine each year and to enhance the role

of the Federal Government in assuring manufacturers that there

will be a growing market for their vaccines.

I am concerned, however, that the President’s fiscal year 2005

budget undercuts flu vaccination efforts. Today, the State health

commissioner in Virginia will testify that the President’s budget

does not include adequate funding to cover flu shots for children.

His testimony is that, if adopted, this budget ‘‘will damage immunization efforts.’’

Today is also an opportunity to take stock of our overall public

health readiness. In the wake of the attacks of September 11, 2001,

and the increased concern about the threat of bioterrorism, Congress has appropriated several billion dollars to State and local

public health efforts. This funding led to some improvements, such

6

as in the area of emergency communication. However, there continue to be major gaps.

For example, there are gaps in planning. The nonpartisan Trust

for America’s Health reported in December 2003 that only a quarter of the States have flu pandemic plans. The General Accounting

Office will testify today that not a single State has a plan for hospital response to an epidemic involving at least 500 patients—only

500 patients.

There are also gaps in lab preparedness. In June 2003, the Trust

for America’s Health released a report finding that public health

laboratories are ‘‘dangerously unprepared for an attack using

chemicals as weapons.’’ We will hear additional testimony today

about gaps in training, education and emergency response.

At this key moment, the Federal Government’s commitment to

public health is essential. Investing in public health protects not

only against a flu pandemic, but also against a new infectious disease and potential bioterrorist threats.

Unfortunately, the President’s budget is again a major disappointment. While it extends tax cuts for the richest Americans,

this budget cuts CDC funding 3 percent and reduces the amount

of money going to State and local governments for public health

readiness by over $100 million.

The President has assured the American people that he is doing

everything possible to protect them. His public health budget indicates otherwise. This is a budget that does not take advantage of

this brief respite between public health crises to prepare adequately for the next one.

Congress needs to be sure that the budget it passes does not

make the same mistakes.

I thank the witnesses for appearing today. I look forward to their

testimony.

I thank you again, Mr. Chairman, for convening this important

hearing.

[The prepared statement of Hon. Henry A. Waxman follows:]

7

8

9

10

11

12

Chairman TOM DAVIS. Thank you.

Are there any other Members that wish to make opening statements? Hearing and seeing none, we now move to our first panel

of witnesses.

We have Dr. Julie Gerberding and Dr. Anthony Fauci, who will

discuss efforts being taken at the Federal level to respond to the

influenza virus. They will also describe preparedness coordination

efforts with State and local authorities. Dr. Janet Heinrich, the Director of Public Health Issues for GAO, will discuss the GAO report

that was released this week regarding State and local preparedness

in the event of a bioterrorism attack.

It is the policy of the committee that all witnesses be sworn, so

if you would rise with me and raise your right hands.

[Witnesses sworn.]

Chairman TOM DAVIS. Be seated. I think we have been through

the rules. We have a light in front of you. It turns orange after 4

minutes, red after 5 minutes. Try to sum up in that time. Your

total statement is already in the record, and questions will be

based on the total statement.

Dr. Gerberding, we will start with you and move down the way,

and thank you very much for being with us.

STATEMENTS OF DR. JULIE GERBERDING, DIRECTOR, CENTERS FOR DISEASE CONTROL AND PREVENTION; DR. ANTHONY S. FAUCI, DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES; AND DR. JANET

HEINRICH, DIRECTOR, PUBLIC HEALTH ISSUES, GENERAL

ACCOUNTING OFFICE

Dr. GERBERDING. Thank you, Mr. Chairman, members of the

committee, for allowing me to be here today. What I would like to

do is to frame the discussion about preparedness and why we need

to be prepared for influenza by pointing out the picture of this

year’s outbreak investigation status.

[Slide shown.]

Dr. GERBERDING. You can see in the first graphic here what the

United States looked like in October when a single State, Texas,

was reporting significant localized influenza activity. In just a few

weeks, all of the red States were showing widespread activity. And

by the end of December, almost the entire United States was involved in a very large-scale flu outbreak. Fortunately, as of the end

of January, most of the States now are just showing sporadic or

very localized activity.

But this was a flu season that started much earlier than we have

ever seen, spread faster, and in no time in our history of surveillance have we ever seen that much widespread activity across the

United States at a single point in time. So it was a wake-up call.

Fortunately, it turned out to be not the worst epidemic we have

had, but a warning sign that further preparedness efforts clearly

are necessary. And I certainly appreciate Mr. Waxman’s remarks

about the impending possibility of a pandemic.

[Slide shown.]

Dr. GERBERDING. On the next graphic I have depicted the 1918

flu outbreak and its impact on mortality in the United States at

the beginning of the last century, just to point out what an extraorVerDate 11-MAY-2000 12:07 Jun 03, 2004 Jkt 000000 PO 00000 Frm 00016 Fmt 6633 Sfmt 6633 D:\DOCS\93723.TXT HGOVREF1 PsN: HGOVREF1
13

dinary capability flu does have. This is a deadly virus, and it is a

tricky virus, because it is constantly undergoing evolution, and that

is why we need to get a new flu shot every year. Usually the evolution is in minor steps, so the vaccine in 1 year looks pretty much

like the vaccine in the past year. But occasionally we see very

large-scale changes in the virus, and that is really what traditionally has set off a pandemic.

[Slide shown.]

Dr. GERBERDING. On the next graphic I have mapped out over

time how viruses move from animals to humans and create these

pandemic strains. There are 15 types of flu virus. They are all

present in migratory birds like ducks. These avian viruses are

present in nature in ducks; they usually don’t cause disease. Occasionally they move to other species like chickens, and some of them

cause very severe bird flu disease in chickens like we are seeing

in Asia right now.

Human viruses and bird viruses can mix up in pigs, because pigs

are vulnerable to both infections. And sometimes when this happens their genes get mixed up so a brand new, very novel flu strain

evolves. This is called a re-assorted virus, and when that virus enters the human population, we have never seen it before, none of

us have immunity to it, and a pandemic can occur. This has been

our concern all along, because this happens periodically, as I will

show you in a moment.

But recently we have also begun to be very concerned about the

possibility of these avian viruses directly moving to people and

then evolving in people to become much more efficient in their

transmission from person to person. That has never happened, but

biologically it is plausible, given how these viruses evolve.

So we have two mechanisms where we could end up with a novel

strain of a virus that could set off a pandemic.

[Slide shown.]

Dr. GERBERDING. On the next graphic I have mapped out over

the past century how pandemics in the United States occurred. The

1918 virus was an H1 virus, and that caused the very large spike

in mortality that I demonstrated. In 1957 a brand new virus appeared, an H2 virus, that set off the Asian flu pandemic. In 1968

the Hong Kong H3 virus first appeared and set off that pandemic.

H1 came back a few years later, it did not cause a pandemic in people over age 20 because they had some immunity from the old outbreak, but it did cause a very large outbreak among people under

age 20.

Today we generally have circulating H1 virus, H3 virus, and influenza B virus in the human population. That is why our vaccine

has to contain three different strains of virus in order to protect us

from what is currently common in our population.

But up here at the top of the graph I have shown also the little

clusters of bird flu that have emerged and been transmitted to people over the last several years. This has happened sporadically before, but since 1997 it has been happening with a regular frequency. And it is these bird flu strains that, of course, have our attention right now as their potential for evolving and becoming more

efficiently transmitted in humans.

[Slide shown.]

14

Dr. GERBERDING. On the next graphic I have just provided a brief

overview of the timeline for vaccine development, because it is really this timeline that has caused the biggest challenge in preparation for pandemic flu. As you pointed out, there are 185 million

people in this country who need flu vaccine. What CDC does in conjunction with WHO and investigators around the world is constantly sample viruses, genetically characterize them in our research labs, and anticipate what might be the next strain.

When we see a new virus pop up, we work with it in the laboratory with our colleagues in St. Jude’s in Tennessee and in a laboratory in the United Kingdom to try to create the best possible virus

for vaccine. But that takes time, and we have to get a virus that

is safe enough to work with and is able to be propagated well in

eggs, since that is the methodology we are using. The best possible

timeframe from getting the virus and getting it into a form for vaccination is about 4 months, and that is a best case scenario.

So we are constantly operating under this very narrow window

of opportunity to get the right virus, manipulate it genetically to

be suitable for vaccination, and then produce the vaccine that we

need. And we are doing this right now in an egg base culture system, which is a very old fashioned way of making vaccine, and I

think it speaks to the other challenge in all of this, which is basically the capacity of our manufacturers to utilize this technology in

a fast enough timeframe to get what we need done.

So the three challenges that Secretary Thompson has asked us

to address at NIH, CDC, FDA, and the other departmental agencies as we prepare the Department’s pandemic planning are: No.

1, how are we going to get those 185 million people vaccinated; No.

2, how are we doing to get enough vaccine to assure that we have

the supply we need when we need it; and, third, how are we going

to modernize our vaccine production so that we can get the job

done.

Thank you.

[The prepared statement of Dr. Gerberding follows:]

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

Chairman TOM DAVIS. Thank you very much.

Dr. Fauci.

Dr. FAUCI. Thank you very much, Mr. Chairman, members of the

committee. It is a pleasure to be here with you today, and thank

you for giving me the opportunity to testify before this committee.

I am going to talk to you for a couple of minutes from the perspective of the biomedical research endeavor to meet the threat of

emerging and re-emerging diseases in general, but specifically, for

today’s purposes, influenza.

[Slide shown.]

Dr. FAUCI. This particular map of the world shows just over the

last 20 or so years the number of emerging and re-emerging diseases with which we have been confronted both in the United

States and worldwide. When we talk about emerging diseases, we

talk about brand new diseases. Some examples are HIV and SARS.

A re-emerging disease is a disease that is an old disease but that

reappears in a different form, in a different geographic location. We

have experienced West Nile virus since 1999, which is a re-emerging disease; it has been around for a long time.

But perhaps the epitome of the continually re-emerging infection

is influenza, particularly influenza A, because it has the capability

of slightly changing from year to year, which necessitates our having essentially new vaccines each year, as well as the possibility

and potential to do what Dr. Gerberding mentioned, about changing so dramatically that it is essentially a new virus.

[Slide shown.]

Dr. FAUCI. And the molecular reason for that is really rather

simple. The influenza virus has a number of genes and proteins.

The two that are used for designation are the hemagglutinin,

which refers to the H, where we get the H3, H1, H2; and the

neuraminidase, which is the N. We have an example this year of

both a shift and a potential drift. A drift is a very slight change.

Our vaccine this year had the H3N2 Panama strain. What we were

confronted with was an H3N2 Fujian strain, a slight difference, not

dramatic, but enough to obviate a bit the efficacy of the vaccine.

What we are facing now is the potential for a shift where that

antigenicity changes so much that we are really naive to this, as

Dr. Gerberding just mentioned a moment ago. One of the clear

ways of doing that is when a virus jumps species from an animal

to a human, and this is what we are seeing with the H5N1 right

now in Asia, jumping from chicken to human in Thailand and Vietnam, with the potential of going from human to human.

[Slide shown.]

Dr. FAUCI. This is a chart of the different countries that now

have clear-cut bird flu, two of which have transmission to humans,

as I mentioned. What is wrong with this picture that is different

from years ago is that it is getting worse and worse each year. We

usually see a chicken virus that jumps to humans in a very confined location, as we saw last year and a few years ago. We rarely,

if ever, see the extent that we see now with nine countries. The

reason this is important is that the more chickens that jump to humans, the more humans get infected, and the more humans get infected, the greater the probability of the virus changing enough to

develop the capability of going from human to human.

41

[Slide shown.]

Dr. FAUCI. And when that happens, you have the possibility of

a pandemic, as we saw in 1918–1919; whereas, you yourself said,

Mr. Waxman, and Dr. Gerberding also, there were tens of millions

of deaths for the simple reason that the population of the world

was naive to this type of flu. You didn’t have the years, if not decades, of memory of similar viruses that you were exposed to.

[Slide shown.]

Dr. FAUCI. So what are we going to do about it? As part of the

departmental plan for confronting both pandemic and interpandemic flu, we do the research associated with understanding the

pathogenesis and ultimately the basic research that will allow us

to develop countermeasures in the form of diagnostics, therapeutics, and vaccines. That is schematically diagramed on this

poster here. I want to point out one component of it which is really

very important, and that is the revolution over the last decade in

genomic research, which allows us not only to very rapidly sequence the microbes to give us a good handle on what we are dealing with, but now an example of what we are calling reverse genetics, where you have the capability of essentially recreating at the

genomic level a virus of your choice that clips out the virulence

components, but allows the virus to grow very well in whatever

media you choose, be it eggs or a cell culture media. And that is

what we are doing now with the H5N1 to get a seed virus that

could be used for a pilot vaccine.

[Slide shown.]

Dr. FAUCI. And on this last poster, this really summarizes the

flowchart of the development of influenza vaccine. It starts off with

isolation of the virus in question. The one we are concerned with

now, as I mentioned, is the H5N1 that has jumped from chickens

to humans. To understand the pathogenesis, to get the proper sequence, to do the molecular manipulation, to get it in a seed form

to do a vaccine, and then to make pilot lots and to test those pilot

lots in the NIH’s network of vaccine trials unit. All of that

synergizes with the public health aspects of what the CDC continues to do, as well as other agencies of the Federal Government.

So in summary, the process of preparing for both interpandemic

and pandemic flu is complex and is heterogeneous; there is research and there is public health. All of these need to work together to meet these inevitable threats.

Thank you, Mr. Chairman.

[The prepared statement of Dr. Fauci follows:]

42

43

44

45

46

47

48

49

50

51

52

53

54

55

56

57

58

59

60

Chairman TOM DAVIS. Thank you very much.

Dr. Heinrich.

Dr. HEINRICH. Mr. Chairman, members of the committee, I too

am very pleased to have the opportunity to be here today to discuss

our Nation’s preparedness for managing public health threats such

as these large-scale outbreaks of infectious diseases. Certainly with

the SARS outbreak in 2003, this highlighted the challenges in responding to new and emerging infectious diseases, and the recent

incidents involving Ricin have raised additional concerns about responding to toxic substances.

To assist the committee in its consideration of our Nation’s ability to respond to major public health threats, my remarks will

focus on the State and local preparedness, and Federal and State

efforts to prepare for an influenza pandemic, and my testimony is

largely based on the report that we issued this week.

For the report, we reviewed each State’s progress report on the use of approximately $1 billion of bioterrorism preparedness funding that was distributed by CDC and the Health Resources and

Services Administration in 2002. The progress reports covered the

period through August 2003.

For our report, we also interviewed State and local officials in 10

States and several local jurisdictions. In addition, we updated our

prior work on the status of the national and State plans for responding to an influenza pandemic.

We found that as of the summer of 2003, all States had made

improvements in their ability to respond to major public health

threats, but no aspect of preparedness was fully addressed. In the

area of disease surveillance, about half of the States reported having the capacity of receiving and evaluating urgent disease reports

on a 24 hour a day, 7 day a week basis. However, only a few States

reported having the ability to rapidly detect an outbreak of an influenza-like illness in their State. Similarly, few States reported

making efforts to strengthen links between their public health and

animal surveillance systems in the veterinary community in order

to monitor diseases in animals that may spread to humans, such

as the West Nile virus.

All States participate in CDC’s laboratory response network, a

network of local, State, Federal, and international laboratories that

are equipped to respond to emerging threats. However, only about

half of the States reported they have the capacity to conduct advanced tests for some of the potential bioterrorist agents.

Most States reported that funding from CDC allowed them to appoint an executive director for their bioterrorism program, designate a full-time person as response coordinator, and hire at least

one epidemiologist for each metropolitan area with a population of

500,000 or more. Having dedicated leadership and critical expertise

is important; however, the ability to hire and retain personnel is

still a major concern for State and local health officials who identify work force shortages as a long-term challenge.

Most States reported that hospitals lack surge capacity to evaluate, diagnose, and treat a large influx of patients with an infectious

disease. Furthermore, no State reported having protocols in place

for augmenting personnel in response to such an influx of patients.

Another concern is that few States have regional plans in place

61

that would coordinate the response across State borders during a

public health emergency.

As we reported previously, Federal officials have drafted, but not

finalized, the Federal Influenza Pandemic Plan. In 2000 we recommended that HHS complete this plan, but HHS recently reported that the plan is still under review. States are currently developing their influenza pandemic response plans, but they have

had to make assumptions about what the Federal role during a

pandemic will be. It is still unclear, for instance, whether the private sector, public sector, or both will have responsibility for purchasing and distributing vaccines and antiviral drugs during a pandemic. These assumptions they are making may prove to be incorrect and cause confusion and disruption of supplies at a critical

time if we actually face a pandemic.

In conclusion, while we wish to acknowledge the many positive

changes since we last appeared before the committee, and we have

documented where States have taken actions to improve their ability to respond to a major public health threat, we see that much

remains to be accomplished.

I will be happy to answer any questions.

[The prepared statement of Dr. Heinrich follows:]

62

63

64

65

66

67

68

69

70

71

72

73

74

Chairman TOM DAVIS. Thank you very much.

Let me thank all of you. I think it was excellent testimony.

Dr. Gerberding, let me start with you. I noticed the President’s

budget submission includes, as Mr. Waxman noted, a cut of $105

million for State and local preparedness, but there is a new public

health tool called the Bio-Surveillance Initiative. Does that balance

off? Can you explain how that works? Are we going to be better

prepared or would we be better off restoring the $100 million in addition, or do you have any thoughts on that? Not to put you on the

spot.

Dr. GERBERDING. I am used to it.

As we just heard from the GAO, the States still lack the capacity

in all jurisdictions to rapidly detect an emerging threat, to alert

people 24/7 out to the distal nodes of the response system, and

what the President’s initiative is designed to do is to accelerate our

capacity to detect events at the Federal, State, and local level. So

what we are doing with that investment is creating systems that

allow us to get real-time data from a variety of sources and to identify the emergence of a health threat and immediately communicate that back. Already we are receiving about 350,000 lab reports a day, we are getting information from nurse call lines

around the country, we are receiving clinical data from the DOD

and the VA, and we are synthesizing all that information and creating systems to work with the State and local jurisdictions to accomplish this detection and response mode much more quickly. So

while there is a reduction in the State-to-State allocation for these

activities, we do have this new investment and this new tool that

we think will organize and orchestrate this on a much faster

timeline than doing it 50 times.

Chairman TOM DAVIS. OK. Let me ask you, and maybe Dr. Fauci

as well, how effective are vaccines? If you are vaccinated, does that

give you a 99.9 percent immunity? Why do some people get the flu

and others don’t when they have the same exposure? Just kind of

a primer. I was a political science major.

Dr. FAUCI. Well, that is actually an excellent question that frequently gets asked. In a year in which the vaccine matches the circulating strain of flu, in a healthly young person it ranges from 70

to 90 percent effective. As you get into elderly individuals, the capability of the vaccine to protect against the strain in question diminishes considerably, sometimes as low as 50 percent. And when

there is a mismatch, even though it was only a slight to modest

mismatch, as we saw this year, it sometimes can go down to 30 to

50 percent of efficacy.

It really varies rather considerably on the health status of the individual who is vaccinated, and that is why you see it diminish

with age and in people who are immunosuppressed, people who are

on immunosuppressive drugs, people with HIV infection, people

like that; the capability of their immune system to appropriately

respond to a vaccine gets less and less. But in an otherwise

healthy, young individual it ranges between 70 and 90 percent.

Chairman TOM DAVIS. And I guess even if you don’t have the

vaccine, some people get exposed and don’t have many symptoms.

Dr. FAUCI. Oh, without a doubt.

75

Chairman TOM DAVIS. Because their immune systems are just

strong.

Dr. FAUCI. Yes. And there is a range of responses to a wild type

or confrontation with a circulating virus, such that somebody might

get infected and have such a subclinical illness that they don’t even

know they are infected. And there is a whole range of people who

have mild illness, moderate illness, and then there is a very small

percentage of people who do very, very poorly; they get very sick

and sometimes life-threateningly so, and that is usually less than

1 percent.

Chairman TOM DAVIS. But you can walk around vaccinated, and

there are still other flu strains out there that can nail you.

Dr. FAUCI. Oh, absolutely. There is no question about that, yes.

Dr. GERBERDING. If I could just add one thing, though.

Chairman TOM DAVIS. Sure. Please.

Dr. GERBERDING. Because the vaccine really does save lives. So

we don’t want to give people the impression that there is no advantage to vaccination. It is clearly a life-saving intervention.

Chairman TOM DAVIS. There are other members who brought

this up, that vaccinations can cause the flu itself, where you get

people reacting that get it and otherwise wouldn’t because their

systems respond.

Dr. GERBERDING. This is a common misunderstanding, because

sometimes the flu vaccine itself causes an inflammation or a small

reaction. But flu vaccine absolutely does not give you flu if you are

using the inactivated vaccine, because all the virus particles are

dead. The new flu vaccine that came out this year, that you put

in your nose, is an attenuated strain of virus; it is still alive, and

so it causes a very mild infection that is limited to your nasal tissues. That vaccine sometimes is associated with fever and some

very minor cold-like symptoms. But none of the virus vaccines actually cause flu.

Chairman TOM DAVIS. So there is agreement on that.

Dr. FAUCI. There is no question about it. In fact, you often hear

we, as physicians, sometimes hear, I know Dr. Gerberding and I

both have people say, ‘‘No, I got the flu shot and the next day I

got the flu, so the flu shot must have given me the flu.’’ It is physically impossible for that to happen with a killed virus.

Chairman TOM DAVIS. And on the nasal side, there was something on a Web site this year. Was it misleading? I know there has

been some talk that it can cause flu.

Dr. GERBERDING. As I said, the virus in the vaccine, the nasal

vaccine, is a very weak virus, and it is temperature sensitive, so

it doesn’t grow well at normal temperatures. And it does not actually cause disease, but the hypothetical concern is that if you

passed even this weak virus on to someone with a very depressed

immune system, as Dr. Fauci was saying, that it could theoretically

cause infection in that individual. So as a precaution we recommend that people who receive this very effective FluMist vaccine

don’t have direct contact with others who are very

immunosuppressed.

Chairman TOM DAVIS. OK, thank you. I may followup on that,

but it is Mr. Waxman’s turn.

Mr. WAXMAN. Thank you, Mr. Chairman.

76

Dr. Gerberding, all of us in the Congress appreciate your hard

work and the hard work and dedication of the scientists at CDC.

They are dedicated people, and we commend them for the job they

are doing. I said in my opening statement that I am concerned that

the President’s budget does not provide adequate support for public

health. You testified that the new recommendation to vaccinate

children between the ages of 6 and 23 months against flu is an important step in saving lives, yet the Virginia State health commissioner is going to testify that the President’s budget does not provide adequate funding to assure States will include the flu vaccine

in their childhood immunization programs.

Are you concerned that the President’s budget does not provide

enough funding for the Federal Vaccines for Children program and

for the State grants for vaccination efforts to assure that children

have access to all recommended vaccines, including the flu vaccine?

Dr. GERBERDING. There has been a change in the way the allocation for vaccines is proposed in the President’s 2005 budget. One

of the changes is to provide an additional $40 million to stockpile

influenza vaccines for children so that we have an additional supply. And in the Vaccines for Children line, these pediatric doses

would then be available to amplify the amount of vaccine that we

have had in the past. In addition, that change in allocation ensures

that additional children will be eligible for childhood immunizations who currently don’t qualify under the voluntary program. By

putting more money in the mandatory vaccination program, we actually will end up with a net increase in the number of children

who can receive vaccines and, in addition, negotiated a much better

price for the diphtheria tetanus vaccine that was too expensive for

many children to receive in the past.

Mr. WAXMAN. That $40 million flu vaccine stockpile is a reserve

supply, it doesn’t really address the issue of routine vaccination

programs. We are going to hear from others, especially the States,

who are going to tell us they feel they are being short-changed. Are

you concerned they might have a point?

Dr. GERBERDING. I am always concerned if the States have a perspective. One of the things that we are doing in the department

right now is looking at how we can predict what the utilization will

be. We are also going back to the ACIP, the immunization advisory

board, and evaluating this year’s flu situation in children to make

sure that our recommendations for limiting the vaccine to that age

group still apply, given the concerns about an additional burden of

illness in children. So we have to look upon this as a work in

progress, and if there are unmet needs, we will do our best to identify them.

Mr. WAXMAN. The GAO is going to report that not a single State

has a plan for hospitals to handle an epidemic of at least 500 patients. We are also going to hear from the Trust for America’s

Health that most States and HHS have not finalized their flu

plans, and that only two States have the capacity to receive and

distribute emergency medications.

When will State and HHS pandemic flu plans be finalized, and

how can we close critical public health gaps as quickly as possible?

Dr. GERBERDING. Thank you. As you know, a plan is one aspect

of preparedness, and the formalized big, thick flu plan is not yet

77

finalized in the department, although I think we do have the final

document together. But there is much more important work besides a written plan, and we saw with SARS how rapidly we were

able to scale up and develop plans for containing SARS, and actually, as you will see on the CDC Web site, the steps that need to

be taken at the local level for managing SARS are the same steps

that we would recommend for flu.

Mr. WAXMAN. Well, we are going to hear testimony that additional funding is going to be critical for this to all happen, and the

President’s budget cuts over $100 million from State and local public health preparedness grants. And in his written testimony today,

the Virginia State health commissioner states these cuts could

jeopardize our ability to respond to a terrorist event, outbreak of

an infectious disease, or other public health threat or emergency.

So it seems to me the States are telling us, even though you answered Mr. Davis’ question by saying that there is money because

of the biosurveillance program, they are saying they see this all as

a cut. If there is a biosurveillance program, that could increase demand for their funds because there can be some sensor that will

pick up something, they will have to divert resources to deal with

it, and yet we are faced with these public health emergencies as

well.

So do you see that the States vigorously disputing this point,

that the States are wrong?

Dr. GERBERDING. As you know, we put about $3 billion into the

States through the various preparedness activities, and we are constantly looking at the evolution of preparedness building from a

pretty dilapidated public health system, and so we have to be able

to sustain these investments for the long term to catch up with

where we should have been all along.

Having said that, I think that our goal is to achieve a level of

preparedness that would be adequate to protect against terrorism

as well as emerging health threats, and we have seen some very

encouraging examples this year where the investments really have

paid off, with the meningitis outbreak in Chicago, the hepatitis A

outbreak in Pennsylvania.

Mr. WAXMAN. Well, I am sure the investments are improving,

but if we are not making the full investment we need, we are not

going to get to the point where we must be if we are going to face

a crisis.

I do want to ask one question of Dr. Fauci before we move on.

Experts have said that a bird flu vaccine is urgently needed. What

is the progress on such a vaccine? Should vaccine companies be

producing bird flu vaccine right now?

Dr. FAUCI. The process of developing a vaccine for bird flu that

might infect humans has already been launched, namely, the seed

viruses are now in hand to a number of groups, including the CDC

and the NIH. They are being produced and we are negotiating now

for the development of pilot lots that will be used in phase 1 studies to determine not only the safety, but what the dosage would be.

That whole process of getting a seed usually takes from weeks to

a month, of getting a pilot lot usually takes a couple of months,

and then an additional 6 months to have the vaccine available. So

we are already going in that direction.

78

We must caution that it is a work in progress, because if there

is a virus that goes from chicken to human, which is what we are

all concerned about, and if it then assumes the capability of going

from human to human, it might change such that it is a bit different from the original virus that went from the chicken to the

human. So you have to move ahead, because you can’t wait, but

you have to keep your eye on what is evolving out there in the

field.

Mr. WAXMAN. Thank you.

Thank you, Mr. Chairman.

Chairman TOM DAVIS. Thank you very much.

The gentleman from Tennessee.

Mr. DUNCAN. Thank you, Mr. Chairman.

I understand from some of the briefing materials that about 87

million people, or about 30 percent of our population, got vaccinated this past flu season. Is that roughly correct?

Dr. GERBERDING. We don’t have the final information yet, but

our best estimate is about 87 million, and that is the largest number of people we probably have ever vaccinated.

Mr. DUNCAN. And then we are also told that ordinarily 10 to 20

percent of Americans get contagious respiratory illness annually.

We have said 30 percent got vaccinated, but of the total population,

of the 285 million people we have in this country, how many people

contracted this flu this season?

Dr. GERBERDING. It is too early for us to give you the absolute

answer to that, but in general, on an average year it is between

10 and 20 percent of all people get influenza; obviously, most of

them very mild disease.

Mr. DUNCAN. And I am not sure exactly how this works. I understand there were three companies that came up with the vaccine

this season?

Dr. GERBERDING. In the United States there are three vaccine

manufacturers that contributed to our supply. There are other

manufacturers around the globe, including companies that make

vaccine for the Southern Hemisphere, which usually has a little bit

of a different influenza profile than the Northern Hemisphere; and

the timing in the Southern Hemisphere is out of sequence with

ours.

Mr. DUNCAN. And how is this paid for? Because I have seen programs where they give out free flu shots and then other places

where they charge. Are these companies totally compensated by the

Federal Government or is it part Federal and part private, or how

is it done?

Dr. GERBERDING. For influenza immunization, the vast majority

of the program is in the private sector, so it is administered

through health plans and private clinician offices and so forth. A

small proportion is in the public sector. For those of us in public

health, that is the part of the vaccination program that is the easiest for us to monitor and to keep track of, but we are developing

new systems so that we will be able to have a much bigger picture

of the whole vaccine supply; where it is, how it is being distributed,

who has it and who doesn’t.

Mr. DUNCAN. And you just said that you sent $3 billion to the

States?

79

Dr. GERBERDING. Over the last 3 years the terrorism preparedness funds. That is an approximate figure based on what CDC puts

out and what HRSA puts out to the hospital preparedness component.

Mr. DUNCAN. But you said that wasn’t just for vaccines, that was

for education and all kinds of things.

Dr. GERBERDING. That money is for six things: for surveillance,

for planning, for laboratory capacity, for information technology, for

communication, and training.

Mr. DUNCAN. Well, rough guess, what percentage of that $3 billion would have been spent on the vaccines themselves?

Dr. GERBERDING. Very little of that money would be spent on

purchase of vaccines, because that is not what the money is specifically for.

Mr. DUNCAN. And the gentleman doctor, I am not sure how you

pronounce your last name.

Dr. FAUCI. Fauci.

Mr. DUNCAN. Fauci? You said that these vaccines were 70 or 80

percent effective in younger people and in older people it was 50

percent or maybe even less?

Dr. FAUCI. That is correct, yes. It varies. The older anyone gets,

even if they are a relatively healthy older person, as you get older,

beyond 60 or so, your immune system does not respond as robustly

as the immune system of a 20 or 30-year-old. So the efficacy diminishes proportionately, although it varies. There may be older people

who have a very good response and are really quite well protected.

Mr. DUNCAN. And I read that each year the health authorities

try to pick three strains of the virus?

Dr. FAUCI. Yes.

Mr. DUNCAN. In advance?

Dr. FAUCI. Yes. What happens is that, as Dr. Gerberding mentioned, toward the end of the winter, the CDC, WHO, and FDA get

involved in doing a surveillance of the strains that are out there,

and in the influenza vaccine shot that you and I get, it contains

two As and a B. For example, this year had an H3N2, which was

the Panama strain; it had an H1N1; and it had an influenza B.

Mr. DUNCAN. Well, let me ask you this, since my time is so short.

How many strains are there out there that you choose from to get

these three?

Dr. GERBERDING. Overall, there are 15 main types of H1s, three

of which are in humans. But the subtypes of those are infinite. So

each little point mutation in the virus can create a new strain, and

we just can’t predict.

Mr. DUNCAN. Because that is what I had heard somebody say at

another time, that there were so many possibilities, it is almost unbelievable.

Dr. GERBERDING. That is absolutely right.

Mr. DUNCAN. And it says the effectiveness of the vaccine is dependent on whether the strains picked will be the same strains to

circulate during the following flu season.

Dr. FAUCI. There will always be minor strains, but what we try

to do is to make the best guesstimate of what the predominant

strain that will circulate the following season is. And generally we

are right about 9 out of 10 times, 8 or 9 out of 10 times.

80

Mr. DUNCAN. Well, I have some more questions, but my time has

run out.

Chairman TOM DAVIS. We may do another round, but thank you

very much.

Gentleman from Maryland, Mr. Van Hollen.

Mr. VAN HOLLEN. Thank you, Mr. Chairman.

Thank all of you for your testimony.

Dr. Gerberding, I just want to take this opportunity to followup

on a hearing we had in this committee last October regarding the

future of the Commissioned Corps of the Public Health Service and

the reorganization plan. And I know you weren’t here at that hearing, but at the time we had a survey from some of the commissioned officers at the CDC which made it clear that they were not

happy with the direction that the reorganization was taking and,

in response to questions, many of them said that if it was implemented as proposed by HHS, that they would seriously consider

leaving the CDC, because it had a number of requirements that

seemed to be not appropriate for some of the scientists at CDC, for

example, emergency deployments in areas outside their area of expertise, certain physical fitness requirements which might not have

really been applicable. And, in fact, Dr. Carmona, the Surgeon

General, said sending officers such as epidemiologists from CDC to

achieve mission objectives that are not consistent with their specific training and physical capabilities makes no sense.

My understanding is, however, HHS has gone ahead and implemented the reorganization plan without the changes the Surgeon

General said he wanted to make in that plan, in his testimony before this committee last October. So my question to you is, is that

in fact the case and what impact is it having on the Commissioned

Corps officers of the CDC? Have you gotten any feedback from

them? And what actions, if any, do you intend to take?

Dr. GERBERDING. I was very concerned about the results of the

survey that you described. We met with Secretary Thompson immediately thereafter, and he was very adamant that his intention

is to improve the corps and to strengthen the corps and expand the

corps, and in no way does he want to interfere with the capacity

of the CDC Commissioned Corps officers to function as effective

disease detectives. So since that time we have set up a series of

interventions, better ways to communicate what the Commissioned

Corps needs are, and we have proposed to the department a special

track in the Commissioned Corps for public health officers that is

under review right now that would accommodate the needs of the

Commissioned Corps and still allow the Secretary to fulfill his mission of having a much stronger and a much more robust Commissioned Corps. So we would be happy to talk with you about those

proposals, and just to say that there is a lot of dialog going on right

now to try to make this go in the best possible way to achieve the

mission.

Mr. VAN HOLLEN. OK, so HHS hasn’t made any final decisions

with respect to the provisions I referred to.

Dr. GERBERDING. The last communication we had was the next

round of the draft proposals, and to my knowledge there has been

no formal decision about the overall transformation.

81

Chairman TOM DAVIS. If I might intervene. Not to take your

time, but Mr. Waxman and I both sent a letter to HHS expressing

our concerns, and we are waiting for a reply as well.

Mr. VAN HOLLEN. I believe you sent a January letter, and I just

want to make sure that the committee’s concerns are being heard,

and I understand your concerns as well. I just want to make sure

they are being heard, and if you can keep us informed about it.

Dr. GERBERDING. Thank you.

Mr. VAN HOLLEN. Because it seemed to have a potentially very

large impact on CDC based on that survey.

Dr. GERBERDING. Thank you. I will make sure that the Secretary

hears your comments today. But I will just tell you right now that

I am absolutely confident that he wants this to work, and he wants

this to work right, so his door is open to us and we are going to

work this out.

Mr. VAN HOLLEN. Thank you.

And, Dr. Fauci, it is wonderful to have you at NIH and my congressional district, so welcome again.

Chairman TOM DAVIS. OK. Let me go with a few other questions.

Dr. Heinrich, the best initial defense against public health

threats continues to be, from what I judge from everybody’s testimony, accurate, timely recognition and reporting of problems. People out there in the field, when something happens, are letting us

know about it. How well developed are information sharing networks between States and the Federal Government at this point,

and do these networks protect privacy while seamlessly connecting

government at all levels?

Dr. HEINRICH. Actually, in the area of the communication electronic network, that is one of the areas where I think there has

been the most progress from our reviews. We have heard from

some of the State officials that information seems to flow best from

the Federal level down, as opposed to the local county through the

State up, but those information systems do seem to be working.

Chairman TOM DAVIS. OK.

Let me ask Dr. Gerberding, how effectively did CDC coordinate

work with the State and local public health officials to respond to

this year’s flu season? Were these efforts reflective of how you and

State and local officials respond to a greater public health threat?

Dr. GERBERDING. Thank you. On December 5th I activated the

CDC’s emergency operation center to coordinate our response to influenza because we recognized with this fast propagation of the

outbreak we needed to have the best possible logistic support. So

we implemented our emergency communication system, we provided regular updates, we had routine conference calls with State

and local health officers. We did our very best to provide the ongoing information and then worked with the bi-directional communications system to try to track vaccine shortages and redistribute

vaccine as indicated. We also fielded information about the need for

pediatric vaccine and anti-retroviral drugs. Secretary Thompson

was able to authorize some emergency purchases of both vaccine as

well as anti-retroviral drugs for the stockpile, and I think overall

we built on our experience with SARS, monkeypox, and West Nile

virus and continued to scale up and speed up our integration at

those levels.

82

Chairman TOM DAVIS. OK.

Dr. Fauci, the purpose of Project Bioshield is to stimulate companies to develop modern and effective vaccines, drugs, and devices

to protect Americans in the event of a bioterrorist attack or a public health emergency. Do you think we need similar incentives to

increase production capacities for flu vaccine manufacturers?

Dr. FAUCI. I think we need to appreciate and recognize that, in

general, transcending biodefense, we have a very tenuous situation

vis-a-vis vaccine development because there are too few companies

involved, and the incentives for companies to make the risky investment in the development of a vaccine are such that we really

are walking on thin ice when it comes to vaccines in general; and

that would apply even to influenza. In general, I think Bioshield

was a very important step in trying to shore that up and prevent

any potential serious problems in going forward with vaccines and

other countermeasures in biodefense.

That doesn’t alleviate the problems that we have in general, and

what we have been having to do is work more closely with the companies to push even further in advance development to take away

some of the risk that they take, because if you look at the incentive

of developing a product in which the risk benefit vis-a-vis profit is

considerably less than a drug, for example, that is very widely

used, the numbers speak for themselves. I mean, there is the classic story that the amount of money made on a single lipid-lowering

drug essentially eclipses all of the vaccines put together. So we

really do have a problem with vaccine development in that regard.

Chairman TOM DAVIS. Is there a flu season where it tends to

peak and we talk about a flu season getting ready, and why is it

a certain time? I mean, it is with us all the time, the virus is

present at all times. Is there a particular season, and why is that?

Dr. FAUCI. Well, in our hemisphere, the season generally goes in

the winter.

Chairman TOM DAVIS. Are you on? See if your mic is on.

Dr. FAUCI. Oh, I am sorry. The season in our hemisphere, in the

United States, Canada, etc., generally starts in the early winter,

December, and generally peaks in January, and then tapers off as

you get to February, and usually is gone by March. That is not necessarily the case in other regions where the temperature is essentially constant or practically constant throughout the year. That is

the point that Dr. Gerberding made just a few minutes ago. With

this year, the cases that we were seeing were unusually early,

which triggered the response of people wanting to get vaccinated.

Chairman TOM DAVIS. Why is it at that time? I mean, is it the

cold weather that brings it on?

Dr. FAUCI. It is a combination of things. The most obvious that

we say, and yet there is some scientific softness about this, but the

generally appreciated explanation is that in the winter months you

have people crowded together and indoors without a lot of good

ventilation, so that when you have a respiratory-born virus, be it

influenza or several others, the possibility of their transmitting

from person to person by aerosolization or droplets increases as

more people spend more time in situations indoors. That is one of

the possibilities.

83

There are also some studies showing temperature and moisture

and other considerations that allow a respiratory-born pathogen to

be able to be transmitted better or not, depending upon the humidity and depending upon the temperature.

Dr. GERBERDING. I would just add one perspective. In this world

of globalization and connectivity and speed, while we have a flu

season here in the winter months, it is flu season in the summer

months in the Southern Hemisphere. So if you looked at the globe,

at any given time of the year there is flu virus circulating, and that

is something that we have to come to grips with as we see now how

these viruses can move so quickly throughout the world.

Chairman TOM DAVIS. That is what prompted the question. Why

here do we seem to have a peak season, although I guess people

get it all the time? And we try to see when a strain is developing,

why information is so important is we see something new developing somewhere; we want to stay ahead of it before it becomes a

much more massive problem.

Mr. Waxman, you had some additional questions.

Mr. WAXMAN. Dr. Gerberding, CDC and the Health Resources

Service Administration developed critical benchmarks to measure

progress by the States. This is a very important process, but for it

to work the benchmarks have to be meaningful. In hospital preparedness, one of the critical benchmarks is that each State must

be able to provide initial evaluation and treatment to 10 adult and

pediatric patients at a time in the entire State. Certainly this is

not a meaningful standard for California, and maybe not for any

State.

I am concerned that some of these standards have been set to

correspond to what is achievable under current levels of funding,

not what is needed for true public health preparedness. This puts

the cart before the horse. Is CDC or HRSA under any pressure to

alter critical benchmarks to match the funding?

Dr. GERBERDING. Actually, what we are doing right now is moving beyond the kinds of generic benchmarks that were included in

the original guidelines, and we are moving to performance-based

benchmarking, where we actually define the capacities. And specifically with respect to flu, in the 2003 budget allocation we have

much more targeted benchmarks that deal specifically with influenza. But what we would like to do at this point in time, now that

we have had a chance to build some basic infrastructure capabilities, is to really hone in on what exactly does it mean to be prepared and how will we realistically know that. We are working

with the State and local health departments to define those new

benchmarks.

Mr. WAXMAN. Well, Dr. Heinrich, maybe you can comment on

this. Have they thrown out these old benchmarks? Are they no

longer meaningful and, therefore, they are meeting certain performance standards that match the needs for public health?

Dr. HEINRICH. In our review and in our discussions with State

and local officials, overall, people found the benchmarks quite helpful in giving them guidance as to how to set priorities, and, of

course, each area varies considerably State by State, and even

within State. We did hear many times that when there were specific numbers attached to benchmarks, it was not always meaningVerDate 11-MAY-2000 12:07 Jun 03, 2004 Jkt 000000 PO 00000 Frm 00087 Fmt 6633 Sfmt 6633 D:\DOCS\93723.TXT HGOVREF1 PsN: HGOVREF1
84

ful. For example, what you just said, for a State to say that they

could manage an influx of 500 people in a State as large as California.

Mr. WAXMAN. Well, it is even less than that. Each State must be

able to provide initial evaluation and treatment to 10 adult and pediatric patients to respiratory isolation rooms in the entire State.

Now, my question is, is this a benchmark that is meaningful health

or is it, one, being driven by the pressure for CDC or HRSA to

match the funding and to set the target so low, the benchmark so

low that it is based on the funding amounts?

Dr. HEINRICH. And I don’t know what the rationale is for those

particular numbers. When we asked officials at the Federal level

and others, we didn’t really get any good answers.

Mr. WAXMAN. Well, let us see if maybe Dr. Gerberding can give

us a good answer.

Dr. GERBERDING. The benchmark you are referring to is part of

the HRSA grant, and so I am not prepared to explain it to you in

detail, but I would be happy to make sure that you get the explanation that you are asking for.

Mr. WAXMAN. In your professional judgment, is that a reasonable

benchmark for HRSA?

Dr. GERBERDING. In my professional judgment, the benchmark

should be based on what is necessary to get the preparedness level

accomplished that we have set out to accomplish. We are staging

preparedness, because you can scale up to any level of threat imaginable, and it is not realistic to expect people to be prepared for the

worst case scenario the first time out, but we are moving up the

scale every single time we put money out.

Mr. WAXMAN. We can also scale down to something that sounds

absurd simply because the money might not be there. So that is a

concern I raise.

There are concerns that the bird flu that is affecting both chickens and people in Asia could be a flu pandemic and my question

for you, Dr. Gerberding, is how many doses of vaccine for bird flu

or another pandemic strain could FDA license manufacturers

produce quickly in case of a flu pandemic? And is this capacity sufficient to meet the public health needs of the United States?

Dr. GERBERDING. Well, that is a complicated question. I will try

to give you a short answer. With the preparation of a bird flu vaccine, where we are starting a new manufacturing process with a

new product, we are already using reverse genetics for this and in

an emergency would probably be able to use a tissue-based culture

system and only make a single, as opposed to a trivalent, product.

Our manufacturers right now, based on their current production,

could make 270 million doses of a monovalent vaccine in the same

amount of time that we make the trivalent vaccine.

So 270 million doses is pretty close to the U.S. population, and

that would be an optimistic projection. That all assumes that timing goes well and that we have the egg capacity and the other

things that we would need to be able to do this, or that we can

quickly get a safe licensable tissue culture system.

Mr. WAXMAN. One of the three FDA licensed vaccine manufacturers produces vaccine for the U.S. market in the United Kingdom,

and this company will testify that in the event of a pandemic, the

85

United Kingdom may prevent them from exporting vaccine to the

United States. In the case of a flu pandemic, how can we be sure

that this company will be allowed to export vaccine to the United

States? And if not, what impact would that have on the flu vaccine

supply? And what has HHS done to encourage vaccine manufacturers to produce vaccine in the United States?

Dr. GERBERDING. Well, that is another area of importance. We

recognize that over the years there have been fewer and fewer

manufacturers engaged in vaccine production, and that creates

vulnerabilities. Some years it creates a vulnerability in terms of

the timing of the availability of the vaccine; other years, like this

year, there was a problem with the total amount of vaccine produced. I think, as I mentioned, the Secretary has told us that we

need to include steps now to expand the production capability of

vaccine in the immediate sense, but also in the longer-term sense,

to really look at what needs to happen to incentivize manufacturers

to be in this business. And we are assembling, through the National Vaccine Advisory Committee, this spring a summary, comprehensive, top-to-bottom review of what needs to be done about

this problem at the Secretary’s request. So we will be able to come

back to you with some specifics on that very soon.

Mr. WAXMAN. Have you looked at the possibility that we might

be barred from exporting from that factory in Great Britain?

Dr. GERBERDING. That is a vulnerability that we are aware of.

We have similar problems with antibiotics at times, and so that is

one of the things that has to be addressed in this review.

Mr. WAXMAN. And just one last question for Dr. Fauci. We are

looking at a prospect for a vaccine that would be cell-based as opposed to egg-based, and it could be then produced in a shorter time.

What is your view of the future of cell-based vaccine? And if the

cell-based vaccine is the wave of the future, are you concerned that

vaccine manufacturers are going to be less willing to get into the

egg-based flu vaccine market, since the sense is that the technology

may become obsolete? Would this create a problem during the transition?

Dr. FAUCI. I believe that it is essential to pursue alternative

methods of producing vaccines. The egg-based method has been

tried and true, and has served us very well. There are some potential difficulties with that, particularly in a situation in which a

virus may not grow well in the egg or might actually destroy the

egg, particularly if it has virulence factors for eggs being a bird flu.

We can get around that partially, or attempt to, by reverse genetics, which essentially clips out those virulence factors that would

be detrimental to the eggs.

But notwithstanding that, we need to do both in parallel, and

that is exactly what we are doing. We are doing research right now

with several of our grantees to try and develop a cell-based tissue

culture approach toward the development of vaccines. Some of the

drug companies are even doing it on their own.

What I detect in my discussions with the pharmaceutical corporations is that they are aware that we need to do those in parallel, and I hope, but I think there will be an easy transition so

that we will have both going and we will be able to go to one or

the other, depending upon the situation.

86

Mr. WAXMAN. Thank you, Mr. Chairman.

Chairman TOM DAVIS. Thank you very much. Is there anything

else anybody wants to say that maybe you didn’t get in or respond

to some other question? If not, great panel. We appreciate

everybody’s time, your testimony, and answering the questions

from the members, too.

We will take about a 2-minute recess while we change the name

tags and get our next panel up. Thank you.

[Recess.]

Chairman TOM DAVIS. I am going to start. I have to swear everybody in on our next panel. I want to thank our witnesses for appearing today. We have Dr. Robert Stroube, the Virginia State

health commissioner. Dr. Stroube and I go back many years. In

fact, your late father George helped me launch my political career

back in 1979, when I ran for the board of supervisors, and then we

worked together in Fairfax when I was chairman of the county

board. And we are just very pleased to have you here today, and

very proud of the job you are doing for the Commonwealth. You

will be testifying on behalf of the Association of State and Territorial Health Officials to provide an assessment of State and local

public health departments’ ability to respond adequately to a public

health threat.

We have Ms. Karen Miller from the National Association of

Counties [NACo], who will provide the perspective from county and

local health officials on preparedness.

We also invited three flu vaccine manufacturers to discuss vaccine production capacities and pandemic planning. Mr. Howard

Pien, who is the president and CEO of Chiron Corp.; Dr. James

Young, president of research and development at MedImmune will

be joining us. Unfortunately, a representative from Aventis Pasteur

was unable to attend, but the company has submitted written testimony for the hearing record. And, finally, Dr. Shelley Hearne, the

executive director of the Trust for America’s Health, produced a

noteworthy report that provides an assessment of improvements to

the public health system and remaining vulnerabilities.

We welcome all of you today. We are just really excited to have

you.

It is the policy of the committee that all witnesses be sworn in,

so if you would stand with me and raise your right hands.

[Witnesses sworn.]

Chairman TOM DAVIS. Ms. Miller, do you have somebody behind

you who may answer questions?

Ms. MILLER. Dr. Susan Allan, who is the health director for Arlington County, VA.

Chairman TOM DAVIS. Oh, great, Susan. I am an old

Arlingtonian of Cherrydale. That is where I went to elementary

school.

Ms. MILLER. It is still Arlington.

Chairman TOM DAVIS. I know. Not in my district, but probably

for the better, looking at their voting patterns.

Let the record show that you are here and sworn in as well.

Dr. Stroube, why don’t I start with you, and I will move straight

on down the line? And, again, thanks for being with us.

87

STATEMENTS OF DR. ROBERT STROUBE, VIRGINIA STATE

HEALTH COMMISSIONER, ASSOCIATION OF STATE AND TERRITORIAL HEALTH OFFICIALS; KAREN N. MILLER, PRESIDENT, NATIONAL ASSOCIATION OF COUNTIES, COMMISSIONER, BOONE COUNTY, MO, ACCOMPANIED BY DR. SUSAN

ALLAN, HEALTH DIRECTOR, ARLINGTON COUNTY PUBLIC

HEALTH DIVISION, DEPARTMENT OF HUMAN SERVICES;

HOWARD PIEN, PRESIDENT AND CHIEF EXECUTIVE OFFICER, CHIRON CORP.; DR. JAMES YOUNG, PRESIDENT, RESEARCH AND DEVELOPMENT, MEDIMMUNE, INC.; AND DR.

SHELLEY A. HEARNE, EXECUTIVE DIRECTOR, TRUST FOR

AMERICA’S HEALTH

Dr. STROUBE. Thank you, Mr. Chairman. Mr. Chairman and distinguished members of the House Government Reform Committee,

I am the State health commissioner for the Virginia Department of

Health and I will be testifying before you today on behalf of

ASTHO, the Association of State and Territorial Health Officials.

I would like to thank the Chair and the committee members for

convening this hearing on a very important public health topic:

emergency preparedness and our current capacity to respond to an

influenza pandemic.

Substantial congressional investment in preparedness for public

health has significantly aided our ability to rebuild Virginia’s public health system. The Health Department in Virginia has become

a 24/7 response agency and is now a key part of the State’s homeland security infrastructure. This funding is being used to help prepare Virginia’s public health and hospital system for a rapid and

effective response to any event, whether it is bioterrorism, a naturally emerging infectious disease such as SARS, a new strain of flu,

or a natural disaster such as hurricane. In order for Virginia to

continue with the ongoing critical enhancement of its response capabilities, sustained funding from Federal grants is essential.

This funding has enabled Virginia to enhance and improve public

health preparedness and planning, infectious disease surveillance

and investigation, the State’s public health lab, its communication

technology, education and training, and health information dissemination. In addition, it has enhanced our ability to develop our

State’s smallpox preparedness programs and our ability to distribute the Strategic National Stockpile.

The President’s 2005 budget proposal includes a $105 million cut

from the CDC preparedness State grant funding. ASTHO opposes

this proposal. Because no State or community is yet fully prepared,

direct funding to the States for preparedness activities must be

maintained at the current level provided in fiscal 2004 funding.

The current proposed cut in funding would result in significant

cuts in both State and local preparedness activities. The proposed

cuts could jeopardize our ability to respond to a terrorist event, an

outbreak of infectious disease, or other public health threats or

emergencies. At a time when States are being asked to expand

their role in disease surveillance and emergency preparedness,

such a cut will jeopardize their ability to protect the public we

serve.

In Virginia, such a cut in funding will reduce our current

progress toward upgrading and enhancing our communication and

88

information technologies. Public health technology infrastructure

has faced serious neglect for many years due to lack of funding.

The Federal grant funding has enabled us to begin to rebuild our

vital information technology system, which is a process that cannot

be completed within just the 2 years that we have had grant funding. Our recent response to Hurricane Isabel, to SARS, the recent

anthrax scare, and the early flu outbreak have demonstrated the

importance of reliable and redundant communication systems.

Once the information systems are established, they must be continuously maintained and upgraded as technology evolves. Such a

funding cut also would impact our State laboratory, which still is

in the midst of upgrading equipment to provide the most sophisticated methods available for rapid detection of biological and chemical agents. A Federal funding cut could also impact Virginia’s ability to provide the best and most comprehensive training available

for health care providers and emergency responders on biological,

radiological, and chemical agents. For a State the size of Virginia,

new training technologies, such as distance learning, are essential.

Funding cuts could impact the health department’s ability to provide education and training programs, which are necessary to ensure our response work force is always knowledgeable about the

latest science.

With regard to unspent grant funds, it is important to know that

any delays in spending of grant funding are due to the difficulties

of hiring such a large quantity of highly qualified staff in such a

short period of time. In addition, large expenditures have now been

obligated for upgrades in highly sophisticated technology equipment. Virginia went to great lengths to properly research available

systems prior to making decisions about what to procure. We also

worked closely with other State and local emergency responders to

ensure that we made wise purchases. Virginia is ensuring that its

funding is being utilized to purchase technology that will effectively

serve multiple purposes and correspond with its local emergency

response partners’ communication systems.

The current influenza season has certainly been a challenge for

Virginia. The Governor, last summer, ordered an aggressive campaign to encourage flu vaccination in the State. We provided more

than double the number of flu shots that we typically provide

through our local health departments. This year we administered

more than 160,000 doses of flu to members of the public. During

a more typical year, the health department provides about 70,000

doses of flu vaccine.

While the Advisory Committee on Immunization Practices recommended that over 185 million people be vaccinated, only 87.1

million doses of vaccine were produced. However, this season we

had an aggressive flu campaign and an early outbreak of flu. The

situation was enhanced by extensive media coverage and heightened public awareness and demand for flu vaccine. The result was

the available supply was unable to meet the demand. Public health

worked to promote vaccination. Our efforts were undermined when

the supply was inadequate.

In Virginia, many high-risk patients went without vaccine, parents could not get young children vaccinated, and health care providers could not vaccinate their staff. Attempting to prioritize vacVerDate 11-MAY-2000 12:07 Jun 03, 2004 Jkt 000000 PO 00000 Frm 00092 Fmt 6633 Sfmt 6633 D:\DOCS\93723.TXT HGOVREF1 PsN: HGOVREF1
89

cine to high-risk patients was a local health department nightmare.

In some cases security was needed to maintain crowd control with

demanding patients.

The present system of vaccine production and distribution was

incapable of effectively responding to demands placed on it during

the past flu season. While CDC, Virginia, and other States struggled to redirect vaccine supply, the reality was that people went

unvaccinated.

Today, only three companies produce flu vaccine for the United

States. Two of these companies produce inactivated, injectable flu

vaccine and the third company produces nasal flu vaccine, which

cannot be used for high-risk patients currently. Congress needs to

support the development of a more reliable vaccine production process. The current system is incapable of meeting increasing vaccine

demands or timely adjustment to the vaccine formulation. A review

of the Nation’s influenza program must include a comprehensive

and critical look at all aspects of the system, including the production and distribution of vaccine.

Last, I would like to commend the leadership we receive daily

from CDC. Whenever we have any kind of infectious disease outbreak, CDC provides rapid, clear, and concise communications and

guidance. This communication is provided to the State through conference calls, through their continuously updated Web site, and

publications such as the MMWR. CDC guides public health policy

and provides critical guidance documents needed by both State and

local health departments. In addition, CDC provides routine and

accessible updates on information during public events as it becomes available and is a ready resource to the States through their

emergency operation center.

In closing, I wish to thank Congress for the preparedness funding it has provided over the last 2 years. It has been essential for

rebuilding the public health infrastructure in this country, but this

cannot be seen as a short-term investment. Decades of neglect of

our Nation’s public health infrastructure make continued Federal

investments necessary. We are eager and ready to address any

public health emergency that may emerge in the coming years, but

we are looking to you to ensure that we have the resources we need

to protect the health of our citizens.

Thank you for the opportunity, and I would be glad to answer

questions.

[The prepared statement of Dr. Stroube follows:]

90

91

92

93

94

95

96

97

98

99

100

101

102

103

104

105

106

Chairman TOM DAVIS. Thank you.

Ms. Miller.

Ms. MILLER. Good morning, Mr. Chairman. My name is Karen

Miller. I am a commissioner in Boone County, MO, and also president of the National Association of Counties; and, as you know,

NACo is the only organization that represents county governments

at the national level. Additionally, I would especially like to thank

the National Association of County and City Health Officials,

whose expertise I use today in preparing this testimony.

America’s 3,066 counties vary in geographic shape, size, population, and services they provide, but one common thread is that

they all have an integral role to play in protecting our communities. Counties are the Nation’s ‘‘first responders,’’ responding to

virtually every emergency situation, whether it is a flood, an act of

terrorism, or an outbreak of disease.

Mr. Chairman, I have one overall message for you today. We

have made much progress in public health preparedness, but we

have along way to go. At the local level, the people who work diligently on influenza immunization are the same people who are

working every day to improve public health preparedness for any

type of emergency. As the public health threats to which they must

respond increase, we are asking the same people to do much, much

more with resources that still are very limited. Today, on behalf of

the Nation’s counties, I urge two actions: sustained and increased

Federal funding for public health preparedness, and greater systematic attention by Federal policymakers to the realities of local

public health emergency planning and response.

As this committee has recognized, our communities must be prepared for any disease outbreak, whether it results from an act of

nature or an act of terror. We have all been concerned about the

potential for widespread influenza, because we have seen how it

can take the lives of our children. We remember the scares caused

by the anthrax attacks of 2001, and we want to be sure we know

what our communities will do if the unthinkable occurs.

The good news is that our Nation’s counties are better prepared

now than they were 2 years ago. The infusion of Federal funds for

building State and local public health capacities has helped a great

deal. The plans that are in place will serve us well, whether we

face an outbreak of influenza or smallpox.

We have already benefited from improved public health preparedness, even though there has been no truly catastrophic event.

For instance, although we hope we will never see a case of smallpox, we have made great progress in planning for mass vaccination.

In my own county, the work we did last year on developing a

local health alert network, which was aided in part by public

health preparedness grant funding, improved our response to influenza this year. It enabled us to share current local data about flu

cases and State and CDC recommendations with our local medical

providers. Our new grant-funded regional epidemiologist created

weekly influenza summaries that we sent out to the medical community via the local Health Alert Network. This has improved physician reporting of influenza, which is essential to help us identify

any large outbreak. A regional public health information officer,

also hired with public health preparedness grant funds, serves us

107

and 16 other counties. This has enabled us to help be more

proactive in educating the general public about flu vaccination and

how to prevent the spread of flu.

However, when my health department, or other local health departments, need to respond to influenza, or to a requirement to

vaccinate medical personnel against smallpox as we did last year,

we are still using the same staff that carries out routine public

health activities. The number of hours required to plan and carry

out vaccination clinics pulls many people away from routine duties

and those come to a halt. We just don’t have the resources or the

staff to compensate for these demands. Of the approximately 3,000

public health departments in the country, nearly all are understaffed and underfunded. What we want you to understand is that

we have drawn upon far more local resources than Federal funds

to move forward in the public health preparedness.

We still have a long way to go. We know that large-scale influenza or SARS might resurface in any community at any time. However, we have never had to implement large-scale isolation and

quarantine. In addition, many communities are concerned that

they lack adequate arrangements for what we call ‘‘surge capacity,’’

that is, extra doctors, nurses, epidemiologic investigators, and others who are not needed all the time, but would need to be called

into service to contain an outbreak and care for patients in an

emergency.

It is essential that the Federal Government remember that public health preparedness is not a destination that some day we will

reach and then be able to stop. Rather, it is a journey during which

we will improve little by little, day by day and year by year. We

must always be using exercises to test our abilities and we must

always be training new people, adapting to new technologies, and

preparing to address new threats.

Most local health departments had plans for identifying stocks of

available vaccine and reallocating vaccine among providers in their

community. The unexpected demand for flu vaccine and its subsequent unavailability concerned us because it required us to change

our strategies and our public message midstream. It pained us

greatly when we found ourselves unable to offer vaccination to all

who asked, particularly because the FluMist vaccine that remained

available is unsuitable for children and high-risk groups on whom

we focus our service. There were approximately 70 counties in my

State alone that experienced a flu vaccine shortage this year. Overstocking, though, is way too costly.

Public health requires good collaboration between Federal, State

and local governments because each has an important, unique role

to play. The fact remains, though, that disease outbreaks don’t

occur in States; they occur in communities. It is our counties and

cities that bear the greatest burden for response. In addition, it is

essential to understand that public health preparedness at the

local level does not involve only our public health departments, it

is an overall emergency management system with all the public

and private partners.

In closing, I would like to reemphasize the need for sustained

and increased Federal funding for public health preparedness and

greater systematic attention by Federal policymakers to the realiVerDate 11-MAY-2000 12:07 Jun 03, 2004 Jkt 000000 PO 00000 Frm 00111 Fmt 6633 Sfmt 6633 D:\DOCS\93723.TXT HGOVREF1 PsN: HGOVREF1
108

ties of local public health emergency planning and response. You

know, the best vaccine and surveillance in the world won’t save

any lives if there is no one at the local level to give the vaccine to

the people.

Again, Mr. Chairman, I thank you for the opportunity to testify

before you today. I would be pleased to answer any questions you

may have.

[The prepared statement of Ms. Miller follows:]

109

110

111

112

113

Chairman TOM DAVIS. All right.

Dr. Pien from Chiron. Thank you very much for being here.

Mr. PIEN. Thank you, Chairman Davis and Mr. Waxman, for the

opportunity to appear today.

Drs. Gerberding and Fauci have provided the committee with an

excellent characterization of this past flu season. I would just like

to emphasize one point. Over 80 million Americans were vaccinated

this past season, probably the highest ever. This is a significant

public health milestone, for which the men and women working for

public health should be recognized.

I would like to convey three key messages to this committee: one,

Chiron is committed to meeting demand for flu vaccines in the

United States; two, raising demand is key to increasing supply in

both the normal and the pandemic flu seasons; and three, publicprivate partnerships are fundamental to increasing the country’s

preparedness for the normal and the pandemic flu seasons. To my first point, our commitment. Chiron invested $878 million

this past July to acquire the English company PowderJect, and the

principal driver was the Fluviron and our flu vaccine business, of

which 90 percent is in the United States. Over the last 4 years, we

have tripled our capacity to 38 million doses for the U.S. market

in 2003, and in 2004 Chiron plans to produce 50 million doses, a

30 percent increase over the prior year. We will shortly break

ground on a $100 million new bulk manufacturing facility. Chiron

is investing in bringing innovation to the U.S. market. This month

we plan to file an IND application for our cell culture flu vaccine.

Cell culture, as you heard, is viewed by many as one of the best

ways to defend against a possible future pandemic.

To my second point, demand and supply being intertwined. Demand for vaccines drives increased supply and, therefore, steadily

increasing demand in normal or interpandemic seasons is key to

the preparedness for a pandemic. Put another way, reliable vaccine

supply in a pandemic situation is dependent upon steadily increasing vaccine demand in the interpandemic seasons.

In the short-term, a government guarantee to create a strategic

reserve may increase consistency of supply, but only if it does not

undermine the current private sector distribution system and the

public health distribution system at the different levels of the government and, more importantly, does not undermine the motivation of the private sector to invest in product and technology innovation. Public health interest is therefore best served by achieving

the Healthy People 2010 goal of vaccinating 150 million people

every year. This will reduce the need for the reserve over time.

And this brings me to my third point, the public-private partnership. Public-private partnership is key to raising demand and increasing pandemic preparedness. The Health and Human Services

agencies must be fully funded to continue their leadership role in

these activities. Strengthening our public health infrastructure to

increase immunization rates in the interpandemic years is the single most important initiative today to prepare for tomorrow’s pandemic.

To maximize the country’s preparedness for a pandemic, Chiron

believes that the Congress, the administration, and the private sector must work together on three things: one, expediting the already

114

existing scientific collaborations between the private sector and the

scientists at the NIH to develop new vaccines; two, defining a pathway for speedy regulatory approval of a vaccine for the pandemic

season; and three, clarifying the financing and the indemnification

mechanisms now to ensure rapid initiation of production before the

pandemic arrives.

A pandemic flu is a menacing threat to the Nation’s health.

Chiron pledges to be part of the solution. In the event of a pandemic, Chiron will cease production of our trivalent vaccine for the

normal season and transition to a year-round production for a

monovalent vaccine. Chiron will aim to triple the number of doses

produced, subject to egg availability. Fifty percent of our output

would be from our FDA licensed facility in Liverpool. Once Chiron’s

cell culture flu vaccine is approved, capacity will be expanded even

further. Cell culture will eliminate egg supply as a bottleneck to

speedy production.

My conclusions are therefore threefold: Chiron has invested

heavily in the flu arena and in the public health interest of our Nation; Chiron is committed to bringing cutting-edge technologies to

the United States to alleviate the threat of a pandemic over time;

Chiron has been and shall continue to be part of the vibrant publicprivate partnership in vaccinology, which is essential to the Nation’s long-term health.

On behalf of Chiron, thank you very much for the opportunity to

express these views.

[The prepared statement of Mr. Pien follows:]

115

116

117

118

119

120

121

122

123

124

125

126

127

128

129

130

Chairman TOM DAVIS. Dr. Pien, thank you very much.

Dr. Young.

Dr. YOUNG. I am really happy to address the committee.

Chairman TOM DAVIS. Well, we are happy to hear you.

Dr. YOUNG. As you know, I am president of research and development at MedImmune, which is a biotech company located just

north of here in Gaithersburg, MD. Today’s topic is of particular interest to me, not only because of my relationship with MedImmune,

but because I am actually a flu virologist by training.

As you may know, MedImmune manufacturers the new

intranasal flu vaccine FluMist, which was licensed by the FDA in

June 2003. FluMist, in addition to being the first intranasal influenza vaccine available in the United States, is a live attenuated

vaccine that provides immunity both systemically, throughout the

body, as well as in the nasal passages, where the virus actually enters the body.

Today I would like to share with you our opinion on what the

most recent flu season has taught us about the United States’ ability to protect its citizens against flu and, most importantly, about

the country’s ability to be prepared in a pandemic situation. Our

thoughts are based upon our experience with FluMist in its first

year of commercial availability. After 30 years of development, costing approximately $1 billion,

and three FDA Advisory Committee meetings, FluMist was finally

licensed for the very limited population of healthy individuals aged

5 to 49 years. Because FluMist licensure occurred late in the influenza manufacturing cycle, we planned for a limited launch and

manufactured at risk about a quarter of our total production capacity of 20 million doses of vaccine. Our manufacturing for the current influenza virus season was virtually flawless, making approximately 5 million doses of FluMist available to the consumer as

early as September, well ahead of this year’s early influenza season. Of these 5 million doses, about 65,000 doses were donated by

our business partner, Wyeth, to college campus vaccination programs. Further, up to 3 million doses were made available for purchase by CDC at a discounted price of $20 a dose, a price at which,

I might add, would require us to sell more than 8 million doses just

to break even financially.

Unfortunately, close to 4 million of the 5 million doses remain

unused to date, and will be destroyed at the end of this year’s influenza season. Thus, in spite of MedImmune’s best efforts to work

proactively and cooperatively with public health authorities to

bring to the market the first innovation in influenza prevention in

more than 50 years, there were 4 million lost vaccination opportunities in this year’s influenza season, which hit early and hard, and

challenged the U.S. vaccine supply and distribution systems.

As such, as we analyze our initial ‘‘very disappointing’’ experience as a flu manufacturer, one of the options we are considering

is whether we should remain in the vaccine business or whether

we should ‘‘cut our losses and get out now’’ rather than face the

overwhelmingly difficult regulatory landscape of bringing new and

more effective vaccines to the marketplace. On our part, to simply

achieve parity with the approved labeling of the old-line, inactivated vaccines, we must spend at least an additional $200 million

131

to achieve safety and efficacy standards the other vaccines were

never required to achieve, or have ever independently proven for

that matter. This double standard is more than enough reason to

cause new manufacturers pause before entering the vaccine business, and our very public experience this season will most certainly

have a chilling effect on others who are considering entry into this

business.

What were some of the factors that contributed to the lost opportunities for vaccination? First, demand for the influenza vaccine is

strongly influenced by policies set by the Federal health authorities. Currently, influenza vaccine recommendations primarily target persons who are less than 2 years of age or more than 50 years

of age, or who have underlying medical conditions that put them

at high risk for complications due to flu. However, the burden of

influenza illness is significant in healthy persons who fall outside

these targeted age groups, and in otherwise healthy unvaccinated

school-age children who serve as vectors for transmission of the influenza to their families and to high-risk individuals with whom

they are in contact. In fact, if you look at the flu season thus far,

from October 2003 through February 2004, 121 influenza-associated deaths among children less than 18 years of age were reported

by the CDC; 49, or 40 percent, were 5 to 17 years of age, and 95

of the children, or 79 percent, had no underlying medical conditions.

Therefore, MedImmune believes that the existing narrowly targeted influenza vaccine recommendations are woefully inadequate

and must be expanded, and that influenza vaccine should be universally recommended for all Americans. This would further the objectives of influenza prevention, ensure continued development of

new, innovative vaccines, and ensure availability of adequate supplies for annual and pandemic influenza seasons. Specifically, a

universal recommendation would drive the demand for routine annual vaccination, which in turn will provide the impetus on the

part of vaccine manufacturers to increase their production capacity

to meet routine demand. This increased capacity will enable manufacturers to better respond to influenza not only on an annual basis

but also in the event of a pandemic which would severely challenge

existing vaccine capacity and the vaccine delivery infrastructure.

Recommendations by the public health authorities are necessary,

but not sufficient, to ensure adequate vaccination of the American

public. Federal authorities need to make the public aware of the

significant burden of influenza in all populations, both healthy and

high-risk, and must enthusiastically endorse new, innovative vaccines as they become licensed and available.

Another factor that contributed to lost opportunities for vaccination in the current influenza season was the misperception that

FluMist could cause influenza, rather than prevent it, as it had

just been approved by the FDA to do so, driven in part by erroneous information provided by public health authorities in public

statements and on government Web sites that clearly stated, ‘‘that

FluMist can cause the flu.’’ While the statement on the Web site

was ultimately changed, it was not changed until after the media

ran with the erroneous information. These statements created damaging misperceptions of FluMist and its benefits, and most cerVerDate 11-MAY-2000 12:07 Jun 03, 2004 Jkt 000000 PO 00000 Frm 00135 Fmt 6633 Sfmt 6633 D:\DOCS\93723.TXT HGOVREF1 PsN: HGOVREF1
132

tainly reduced the number of people protected against this year’s

flu epidemic that included the virulent mismatched Fujian strain.

‘‘Accurate’’ educational materials from our public health officials

are paramount to successfully sharing the benefits of vaccination to

the general public and achieving broad immunization against the

flu.

How is MedImmune contributing to the efforts to prepare for a

pandemic threat? First and foremost, we have already made a considerable investment, to the tune of $1 billion, to overcome the extraordinarily high regulatory hurdles facing new vaccines in order

to make available an important new option for flu vaccination. Second, should we ultimately choose to remain in the flu vaccine manufacturing business, we will undertake the financial burden of

spending hundreds of millions of additional dollars to hopefully expand our indication to include persons younger than 5 and older

than 49 years which, if we succeed in doing, will in turn hopefully

increase the demand for FluMist that will then justify increasing

our manufacturing output to full capacity. Third, we are working

proactively with Federal authorities to develop and test a FluMist

vaccine for use in a pandemic situation. And, fourth, we have

worked closely with the World Health Organization to make

MedImmune’s intellectual property in the area of reverse genetic

engineering available for development and testing of inactivated

pandemic vaccines.

So in conclusion, the core of my message to you today is that in

2004, in the wealthiest and most powerful country on Earth with

the world’s best health care system, it should be unacceptable to

all of us that more than 100 American children and countless elderly have recently died from a completely preventable disease. Importantly, this year is not unique. Every year 36,000 Americans die

from influenza. The best way for us to be prepared to prevent this

from happening in the future, as well as to help make sure we are

prepared to deal with a pandemic situation, is to have the current

flu vaccination recommendations expanded to include all Americans, especially expanded to include that all healthy children be

vaccinated against the flu.

Thank you very much for the opportunity to present today.

[The prepared statement of Dr. Young follows:]

133

134

135

136

137

138

139

Chairman TOM DAVIS. Thank you very much.

Dr. Hearne.

Dr. HEARNE. Good morning. I am Shelley Hearne with the Trust

for America’s Health, which is an independent organization working to prevent epidemics and protect people. And thank you, Chairman Davis and Mr. Waxman, for holding this important hearing.

It is certainly a timely one. Just last week we were reminded, with

the ricin scare on Capitol Hill, as to how vulnerable we are for

many health threats. Fortunately, no one was killed in this incident, at least this time, but it could have been worse.

One of the things that happened in the anthrax event of 2001

was the rampant scare around the country, which overwhelmed our

public health system. That could have happened here with ricin,

and if it had we would have been in worse shape. In part, public

health is not prepared for a variety of health threats. Just take a

look at the public health laboratories. Most labs cannot test for

ricin, and the majority of them do not have a chemical weapon response plan.

So I know we are at an influenza hearing, and you may ask me

what has this got to do with the flu. It is actually everything. One

of the things we certainly know is that mother nature can rival the

best of terrorists out there. We have had 35,000 people routinely

die from the flu, and if a pandemic came along, we certainly

learned this in 1918, it can kill hundreds and thousands of more

people.

So is it possible to prepare for the threat of bioterrorism and at

the same time to effectively prevent, contain, and reduce an influenza pandemic? Unfortunately, it is not the kind of public health

system that we currently have today, but I would argue is just the

defense system that we need. However, America is very far away

from reaching that goal.

In December, our organization released a report, ‘‘Ready or Not?

Protecting the Public’s Health in the Age of Bioterrorism.’’ We

found that 2 years after the September 11th attacks, and almost

$2 billion in new Federal funds, we have made a lot of progress in

preparing for public health, and that has been echoed certainly

with the panels today, but there is much more that needs to be

done.

For example, we found that CDC and the majority of States do

not have pandemic flu plans. This, coupled with minimal oversight

of Federal and State strategies, shows a failure to translate our

concern about bioterrorism into a comprehensive strategy for public

health preparedness. Another major finding is that only two States

were prepared to distribute and administer emergency vaccination

or antidotes from the strategic national stockpile. And while significant improvements have been made in the labs, only six States report that they have sufficient facilities should a major public health

emergency occur.

Finally, our report revealed that since the September 11 attacks,

two-thirds of the States have cut their State public health budgets.

And now the President’s 2005 proposed budget threatens to compound the impact of those cuts by slashing support for State programs. As has been noted before, this includes cutting the State

and local bioterrorism preparedness by $105 million. Overall, CDC

140

is facing a 3 percent budget reduction, just at a time when we need

this agency to be even stronger.

To stop the hemorrhaging of the Nation’s public health infrastructure, we are recommending a series of ‘‘fixes’’ to move us toward that modern system with the capacity to fight a multitude of

hazards. Rather than concentrating solely on bioterrorism or responding to each ‘‘disease du jour’’ crisis, public health preparedness efforts must be focused on all hazards. We need to simultaneously address the potential for biological, chemical, radiologic,

and natural disease outbreaks. TFAH is recommending that the

CDC authorize States to use Federal preparedness funds to support

an all-hazards approach. CDC must work with the State and local

health officials to define measurable and mandatory preparedness

standards. State or local governments must demonstrate to CDC

that core public health funding levels are met, thereby ensuring

the maintenance of effort. We believe that Congress should make

a long-term investment toward biosecurity and authorize an independent review to determine whether current expenditures are sufficient.

Let me add that the Trust for America’s Health conceptually

does support the President’s Bio-Surveillance system and also upgrading the Bio-Watch Program, but we do not believe it should

come at the expense of funding for State preparedness initiatives,

which have been cut by 11 percent. We also endorse increasing the

discretionary programs in the public health service by 12 percent.

At a time when U.S. health care spending averages about $1.7 trillion, we believe that public health programs that prevent, control,

and treat disease are essential to reducing America’s health care

bill.

Last, we recommend that Congress, in consultation with the

President, convene a summit to develop a cohesive national approach to public health protection. We need a blueprint for the 21st

century, and the summit should address all threats to our Nation’s

health, including chronic diseases, infectious and animal-born illnesses, food safety, and terrorism. Whether it is anthrax or the

avian flu, public health defenses must be fortified, not forfeited. To

do otherwise would guarantee only chaos and a staggering loss of

life should a public health emergency occur.

Thank you for the time and for being part of this public policy

debate.

[The prepared statement of Dr. Hearne follows:]

141

142

143

144

145

146

147

148

Chairman TOM DAVIS. Thank you all. Thank you all very much.

Let me start, Dr. Young, with you. Four million doses were destroyed last year. Was that the effect of the fact that the target

population, those under 5 and over 50, that your doses were not

recommended for them, or do you think it was the misinformation

that was put out on some Web sites, or a combination? I mean,

clearly those doses could have been used by people between 5 and

50, instead of some of the other doses that were used from other

areas, and the reallocation we would have had, in theory, I would

think, 4 million more doses available to people and might have

saved some lives.

Dr. YOUNG. Absolutely. I think there were a number of factors

that contributed to that. But it wasn’t without our trying to get the

vaccine out. We actually had discussions with the CDC in December about giving them a million doses, take them free; we are going

to throw them out anyway. Take it free, you can have it. They said,

we can’t use that many doses; maybe we could take 250,000 doses.

They never came back and took those doses from us. But we tried

our best.

Chairman TOM DAVIS. I bet you, Dr. Stroube, and Mrs. Miller

can use them in your areas, right? I mean, I think you hit the problem in terms of the distribution of this. Maybe we didn’t see the

problem at that point, either, developing the way it developed.

Dr. YOUNG. It was actually the day before Christmas, well into

the epidemic.

Chairman TOM DAVIS. Keep going, I didn’t mean to interrupt.

Dr. YOUNG. No, I think there are other issues about

misperceptions, misconceptions, the public health authorities not

getting behind this new innovative vaccine. You even heard today

talk about how the inactivated vaccine, it was your question, is

only about 70 to 90 percent effective when the strains are matched,

only about 30 to 50 percent effective when the strains are mismatched. We have data in our package insert from a clinical trial

we did in children that the first year of the vaccine, when tested

in those kids, was 95 percent effective. That was when the strain

was matched. And the second year, when it was not matched, 87

percent efficacy.

Chairman TOM DAVIS. Do you think the nasal is more effective?

Dr. YOUNG. It is an afterthought of the public officials to talk

about that vaccine. It is a great vaccine, yet it is sort of in the category of hand washing.

Chairman TOM DAVIS. Just to give you your day here, do you

think the nasal is better than the ordinary vaccine, more effective

for the target populations that you are looking at?

Dr. YOUNG. We haven’t done head-to-head trials. In fact, those

trials are underway right now. We actually expect to unblind a couple of trials in a couple of weeks, and we plan on doing another

head-to-head trial. All I can tell you is we have the data in children

that shows that it is between 80 and 96 percent effective. I don’t

know that such data exists to show that kind of efficacy with the

inactivated vaccines.

Chairman TOM DAVIS. The only thing I can say is we have three

producers of flu vaccines, and if you go out, it makes it a lot tougher.

149

Dr. YOUNG. Well, it is hard to justify staying in the business and

hemorrhaging money left and right.

Chairman TOM DAVIS. Oh, I understand. Let us continue to

work.

Dr. Pien, let me ask you. Of course, you are in the business as

well. The one thing that concerns us is not anything that you are

responsible for, but that is if there is a pandemic around the globe,

the fact that your manufacturing sites are in Britain. Is there any

way that you have to serve Great Britain or Europe first, and not

America, that would limit your ability to disburse those?

Go ahead and answer that, and then I have another followup.

Mr. PIEN. Mr. Chairman, I would say that this is really a subject

of some speculation. We have no knowledge that the government

of Great Britain would actually restrict the flow of the products.

And all we can do, of course, knowing that this is something outside of our control, if it should arise, is to do our best to increase

the total production capacity and make the investment to enable it,

and that is both in terms of the conventional egg-based technology

as well as flu cell culture flu, as I mentioned before in my testimony.

Chairman TOM DAVIS. I think it is to our advantage to keep everybody in business.

How much does it cost to put a dose together in each case, once

the basic research is done, then to develop the dose and decide how

much you are going to do? You get some economies of scale there,

but this year we fell behind because it takes a period of time, I

guess, to work a batch up. Is that the correct understanding?

Dr. YOUNG. Yes, that is correct. By the time you actually get the

strains, optimize the growth of the strains in the eggs, and then

produce, test, have the FDA review and release the product, it is

many months, upwards of 6 months or more.

Chairman TOM DAVIS. But once you have gotten one batch done,

isn’t it cheaper and faster to do the second? You don’t have to go

back and do basic research.

Dr. YOUNG. No, you don’t have to go back and do basic research,

but the timeline for production, testing, and release is the same for

every batch. Now, in terms of the cost, I can tell you that the cost

per vaccine is driven in large part by the level of manufacturing

you are doing. For us to just turn on the lights in our plant costs

$60 million, if we don’t even make a single dose of vaccine. And

until we actually get up to the point where we are above 4 or 5

million doses at the current retail price, we don’t make a single

dime on the product until we are above that; and you don’t get

down into really reasonable margins until you are up in the range

of 15 to 20 million doses of production. So there is a certain fixed

amount of cost that we have no matter how many doses we

produce.

Chairman TOM DAVIS. But the economies of scale mean the more

you produce, the cheaper, basically.

Dr. YOUNG. The more you produce, the cheaper it is.

Chairman TOM DAVIS. Is that the same?

Mr. PIEN. I would generally concur with Dr. Young’s comment,

except to amplify a few points. First of all, you have to make ongoing capital investments to keep up with the ever-rising standards

150

of quality control which the FDA insists on, and has the right to

insist on. One of the reasons that we are making this $100 million

investment is precisely for the reason of wanting to bring state-ofthe-art capacity to the buildings and the machinery and so on, such

that as the standards rise for quality control and quality assurance, we make the products that meet those standards.

I would also say that there is a general perception that the vaccines are probably less profitable than pharmaceutical products. I

think the real reason for this is because every year you have to

make new products, and every vaccinee, as it were, is a new patient; there is no refill as you would have for any hypertensive, for

example. So these are issues that do contribute to profitability.

I think most of us who are in the vaccine business, and are remaining in the vaccine business, understand that it is part of our

social covenant that if we have the technology, we have the knowhow, vaccinology is one of the most important ways that medicine

can make a contribution to human health care and to the country’s

overall protection.

Chairman TOM DAVIS. What is the shelf life of an average dose?

Dr. Young, you talk about destroying maybe 4 million doses. Is that

because they are not usable in the next year?

Dr. YOUNG. Yes. Actually, the shelf life is mandated by the FDA

that it expires on June 30th, after the season, so that there is no

misuse of the wrong vaccine the following season after the strains

have changed.

Chairman TOM DAVIS. OK, that is the FDA’s ruling.

Dr. YOUNG. That is correct.

Chairman TOM DAVIS. But as a practical matter, if you were to

put this in a refrigerator and store it, would it still have potency

5 years later if that strain came back?

Dr. YOUNG. You would need to store it, in our case, because of

a live vaccine, you would need to store it frozen at very cold temperatures, and it has a very long shelf life. But the problem is, as

you heard from Dr. Fauci, the strains must be updated every year

for the ones which are in circulation, so this year’s vaccine probably

isn’t going to be very effective next year.

Chairman TOM DAVIS. No, it wouldn’t be, but 5 years from now

it could come back, couldn’t it?

Dr. YOUNG. Usually that doesn’t happen. It is very rare that the

same strain will actually reemerge back into the population, because everyone is immune to it. They have already seen it, so the

virus is tricky enough to figure out that the only way it can continue to circulate in the population is it has to change to the point

where no one’s prior immunity can protect them against that

strain.

Chairman TOM DAVIS. Even if you have a regional outbreak here,

that is just the way it works.

Dr. YOUNG. That is just the way it works.

Chairman TOM DAVIS. OK. I understand that.

Dr. Hearne, in your testimony you said States are experiencing

a shortage of trained public health specialists and epidemiologists.

How serious is this crisis?

Dr. HEARNE. Well, it is actually getting worse because we are

finding that the pipeline doesn’t exist for many of the epidemioloVerDate 11-MAY-2000 12:07 Jun 03, 2004 Jkt 000000 PO 00000 Frm 00154 Fmt 6633 Sfmt 6633 D:\DOCS\93723.TXT HGOVREF1 PsN: HGOVREF1
151

gists or technical staffers, particularly in Virginia which has built

one of the top labs in the country, but is seeing problems with work

force and the ability to pay highly skilled, highly trained people.

That is just one area of the gaps that we are seeing. Certainly

there have been improvements in communications in some of the

other areas, but there are still also gaps in making those labs even

better, doing some of the better disease surveillance; number of

holes that continue to need to be filled.

Chairman TOM DAVIS. OK.

Dr. Stroube, do you have any thoughts on that?

Dr. STROUBE. Well, we have been fairly lucky. The lab is a little

bit harder to do because you are looking usually for Ph.D.s that are

really state-of-the-art, and there is a demand for those. In finding

epidemiologists, we actually created 140 new positions in the

health department using the Federal money on it, and we put an

epidemiologist in every health district in the State, we have 35 of

them, and planners. And we had some difficulty recruiting, but we

have been fairly successful in doing that. Part of it, we are close

to a lot of public health schools and we have a fairly attractive

place to recruit people in, so we have done pretty well in trying to

recruit people. But that is a long-term consideration we have been

thinking about, and we have been working with public health

schools and trying to get more people trained in the way we need

them.

Chairman TOM DAVIS. You also mentioned in your testimony

that not all of the Virginia health care workers were immunized

this year with the flu vaccine. I guess we ran out of it through the

process?

Dr. STROUBE. We ran out in December, just suddenly. We were

going great guns. Like I said, we put a lot of emphasis on flu this

year, and part of it was to be prepared for SARS. It is hard to distinguish flu from SARS, so the more people we have immune to flu,

the easier the job dealing with SARS, we thought it would be. So

we really put a lot of effort into that and we started immunizing

everybody in the health department, nursing homes, hospitals, and

really pushed hard on that.

Chairman TOM DAVIS. Well, let me ask you and I will ask Ms.

Miller and also Dr. Hearne. We really are not ready for prime time

if you get a pandemic at this point, is what I gather from the first

panel and this. Obviously we are making strides, we are getting

better each year we get a test, but is that fair to say?

Dr. STROUBE. Well, I think the biggest problem is vaccine availability on it. For 3 out of the last 4 years we have not had adequate

flu vaccine supplies; it has either been late due to manufacturers

dropping out, and we just haven’t had the material that we need

to be able to enact a pandemic flu plan to get people to do that.

Until we have the flu vaccine, plans aren’t really effective.

Chairman TOM DAVIS. Did you use any of the nasal vaccine?

Dr. STROUBE. We used some of the nasal.

Chairman TOM DAVIS. For part of the population?

Dr. STROUBE. For part of the population. It started becoming

available to us at the discounted price later in the game on it. Part

of the problem we have with that, we have health departments all

across the State, and as Dr. Young said, you have to maintain that

152

at a very low temperature, which is a little hard for us to do in

distribution systems.

Chairman TOM DAVIS. But we have to get better at it, obviously,

the way you are going.

Ms. Miller, do you have any comment on that?

Ms. MILLER. I would just comment that local governments have

a limited amount of dollars to buy vaccine with, and so I don’t

know what the cost is between the two differences, but I would like

to ask Dr. Allan if she could just comment on that, if that had an

effect on why the FluMist was not used effectively.

Chairman TOM DAVIS. Sure. We have sworn her in. Let us hear

from her.

That will be my last question, then I will yield to Mr. Waxman.

Dr. ALLAN. At the local level, the implementation of an expanded

influenza vaccine program this year was a real challenge. The vaccine supply issue has been a concern for several years, as Dr.

Stroube mentioned. Beyond that, though, we ended up putting

twice as much staff time into doing the flu vaccine program this

year as we normally do, and I can’t frankly tell you whether that

was a success or not from a public health perspective, because

those staff were doing influenza vaccines which needed to be done,

instead of doing care to pregnant women or routine other vaccines

to children or investigating hepatitis, which also needed to be done,

because we do not have any cushion, any expansion in our staffing.

So to hit a surge like something like influenza means that we are

stopping other things that are also affecting the health of the communities in maybe less dramatic, but probably just as important a

way.

So I think our program, for example, declined the FluMist vaccine because we had already made an extra outreach to the highrisk populations, which we do consider our primary responsibility,

and we had no more staff time just to give the lower-risk people

the vaccine. We tried to let the private doctors know it was available. We couldn’t have done any more than we did, having already

doubled the staff commitment to this program at a cost to others.

Chairman TOM DAVIS. OK. Thank you very much.

Mr. Waxman.

Mr. WAXMAN. Dr. Stroube, in your written testimony you stated

Virginia does not include the pneumococcal vaccine in its childhood

immunization program. Is this vaccine important and is it recommended, and what are the implications of Virginia not including

this vaccine in its immunization program?

Dr. STROUBE. The Prevnar vaccine, which is pneumococcal for

children, has been recommended by the Federal authorities for several years now, but it is an expensive vaccine and we have been

unable to afford to give it to all the children that need it, and so

that makes them at risk of pneumococcal diseases such as pneumonia and ear infections.

Mr. WAXMAN. What are the lessons of this experience for the new

recommendation to provide flu vaccine to young infants?

Dr. STROUBE. I think any time there is a recommendation to expand or bring in a new vaccine, it has to come with money, because

there just isn’t any money available. We are looking at the vaccine

purchase appropriations increasing by 50 percent since 1999, but

153

yet the cost of giving a child all the recommended vaccines has increased by over 125 percent. So we are falling behind, particularly

every time we get a new vaccine.

Mr. WAXMAN. Well, it is troubling to realize that the President

is proposing to make permanent tax cuts for the richest Americans,

but his budget can’t fund the childhood immunizations adequately.

Are you going to find yourself making progress under this proposed budget or are you going to fall backward?

Dr. STROUBE. Well, we will do the best we can under what we

have and prioritize what we do and try to use all the funding we

can both from the State and Federal Government to meet the needs

as we see them.

Mr. WAXMAN. I wonder if I can direct some questions to Dr.

Susan Allan, if you would.

Dr. ALLAN. Absolutely.

Mr. WAXMAN. The General Accounting Office is reporting today

that the smallpox vaccine program has diverted resources from core

public health activities. Do you agree this diversion has been a concern at the local level? And if so, can you give us any examples?

Dr. ALLAN. The smallpox vaccine program took a tremendous

amount of concentrated effort. I am actually speaking at a conference next week on this, and the title of my presentation is,

‘‘Making Lemonade From A Box of Lemons.’’ Dr. Stroube already

mentioned I am in the State of Virginia here, and we have two

staff with all of the Federal money, with the commitments required

at the State level for the labs and technologies and other things.

At the local level we had enhancement by two staff in our health

department. It took 22 people the equivalent of a week’s time just

over the first couple months of the smallpox program, plus 3 of us

essentially full-time for 4 months just for the startup implementation of this. So the cost in terms of redirecting our resources was

considerable.

Now, we tried. We are good public health people. We tried to

turn this into general principles of infection: education, disease control, certainly enhancement with our relationship with the doctors

and hospitals. So there were some benefits to this, but the cost to

our system was a major disruption for a full 6 months.

Mr. WAXMAN. That is interesting, because Secretary Thompson

assured us there would be adequate Federal funding for the smallpox program, and what we are hearing is that this program may

have actually undermined some core public health activities.

Dr. ALLAN. If I may add a point, the Federal money came to the

States with, in effect, a contract. It is a grant process, so the States

had pre-committed, as we did in our role with the States, to what

would be done with the money that came. So we already had a full

workload agenda that used all of the resources provided, and then

the smallpox program was dropped on top of that. Compensation

was provided after the fact, but we don’t run the local budget by

going in the hole. So we didn’t create extra expenses for that, we

cut other commitments. So by the time, at least for many of us,

that the Federal money came, it was too late to do any good,

whereas if it had come with the commitment, there might have

been some value.

154

Mr. WAXMAN. Well, obviously this was, I would think, an unintended consequence, and I am interested in your view. The administration’s budget is investing heavily in bio-surveillance technologies. Are there any potential unintended consequences to Federal efforts to detect bioterrorist agents in the environment? And

in the event of false positive results, could these efforts generate

more work and divert State and local officials from core public

health activities?

Dr. ALLAN. A number of our communities have already had experience. A lot of the military establishments and some post offices

have had this. Here in the National Capital region, the Anacostia

Post Office had a false positive on an anthrax test just a couple

months ago, in November. Arlington had three post offices that

were shut down until we knew for sure that was not a true positive, that it was in fact a bad test result.

Meanwhile, there were 10 of us who spent the equivalent of almost a day and-a-half full time on this, and we put together a

treatment clinic for the postal workers because we didn’t know

whether they had been exposed or not. We had 90 staff we brought

in on overtime and set up a clinic to treat them, for one false positive. Rough estimate of the cost to us was about $10,000 for that

one false positive test. And these technologies are untested and

unproven; they generate a lot of errors that, every time there is a

hit on these systems, we are going to have to drop whatever we are

doing and investigate them. So, you know, it is like having a smoke

detector. If you don’t have a fire department to respond and see if

it is a real fire or not, what is the point of the smoke detector?

Mr. WAXMAN. Dr. Hearne, I understand Trust for America’s

Health is a nonpartisan and nonprofit organization that focuses on

the need for a robust public health system in this country. From

your perspective, what, if anything, concerns you about the President’s fiscal year 2005 budget?

Dr. HEARNE. Part of our concern has been just at a time when

we have had a series of wake-up calls—the flu outbreak was just

the beginning, we have had, since then, the avian flu, certainly

SARS before, anthrax and ricin last week. We are getting

bombarded with a number of very strong wake-up calls that our

public health system is a critical part of our homeland security.

But in fact what we have found in our investigation is that it probably is the weakest link in homeland security. What concerns us

is there are a number of gaps that we have identified and now is

the last time that you should be considering cuts to this budget,

when in fact there are very specific initiatives that need to be advanced, particularly to protect us from all flanks. And so just the

fact the word ‘‘cut’’ is being used in the same sentence as CDC is

troubling.

Mr. WAXMAN. I understand you have a score card of State preparedness, and the scorecard revealed that even as the Federal

Government was increasing resources for public health, many

States have cut their public health funding. How important is it to

track actual spending on public health by States and localities?

And as far as you know, is the CDC tracking actual spending by

States and localities? And is it troubling that even at the same

time the administration is proposing to cut public health funding

155

for States, it is failing to closely track actual spending on necessary

activities?

Dr. HEARNE. Let me try to break that down in a few ways. One,

our report did find that approximately two-thirds of the States

were opening up the back door, they were removing funds from

their critical public health programs just at the time when Federal

funds were coming in, which risked diluting the important investments that the Federal Government was making. That is disturbing. The even more troubling point in this, as you were raising concerns about accountability, we were not able to get this information

on State expenditures and investments on the public health side

from CDC. In fact, we have received a number of calls from CDC

to have our data because they would like to know. It is important

that they are asking to know, but they should have known this for

a long time because certainly as one is looking to purchase better

protection and safety for the American citizens, you need to know

where your money is going; you need to know what you have

bought. And the fact that there has not been that accountability

measure, one, you can’t track what is happening in the States, you

can’t compare one State’s activities to another.

We actually had to contract with the National Conference of

State Legislators to get this data, which we are happy to provide

to CDC, but it should be a routine matter of tracking and accountability. Just as we should be tracking diseases in this country, we

should also track where the money is going.

Mr. WAXMAN. Thank you.

Mr. Pien, from your perspective, what can the Federal Government do to support the quickest possible development of pandemic

flu vaccine?

Mr. PIEN. Mr. Waxman, as I testified before, I think that one of

the most important aspects of the private-public partnership has

been that of the advancement of technology and sciences. In this

regard, if we are going to be able to advance the funding level with

the National Institutes of Health, or at least keep it at a level that

can perpetuate these kinds of partnerships, it would go a long way.

Second, I think that the considerations of how we appropriate resources such that we can enhance the level of natural growth in

demand will go also a long way to the ability for manufacturers in

toto to be able to steadily increase their investment and increase

their capacity.

So the collaboration between the private sector in thinking about

how they can propagate the messages about the seriousness of the

disease that flu represents, along with the funding that the CDC

and all of the States and municipal and county agencies that preside over infrastructure that will get the vaccines into the arms of

the people who need it, I think that will go a long way to prepare

the country’s readiness for pandemic.

Mr. WAXMAN. I want to thank all the panelists for their presentation.

Mr. Chairman, I wonder if we could keep the record open for a

short time to see if we can elicit further responses in writing from

some of the witnesses.

Chairman TOM DAVIS. Well, some offered to do that. We will

keep the record open for that. And in addition to that, we had some

156

witnesses who couldn’t come who submitted written testimony, and

that will be put in the record.

I want to thank our witnesses today. It has been very helpful to

us. I want to thank you for your testimony.

I want to thank the committee staff that worked on this hearing,

and we are adjourned.

[Whereupon, at 12:31 p.m., the committee was adjourned, to reconvene at the call of the Chair.]

[The prepared statement of Hon. Congressman Elijah E.

Cummings and additional information submitted for the record follow:]

157

158

159

160

161

162

163

164

165

166

167

168

169

170

171

172

173

174

175

176

177

178

179

Æ