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VIRAL HEPATITIS: THE SECRET EPIDEMIC

HEARING

BEFORE THE

COMMITTEE ON OVERSIGHT

AND GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED ELEVENTH CONGRESS

SECOND SESSION

JUNE 17, 2010

Serial No. 111–93

Printed for the use of the Committee on Oversight and Government Reform

(

Available via the World Wide Web: http://www.gpoaccess.gov/congress/index.html

http://www.house.gov/reform

(II)

COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM

EDOLPHUS TOWNS, New York, Chairman

PAUL E. KANJORSKI, Pennsylvania

CAROLYN B. MALONEY, New York

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

JOHN F. TIERNEY, Massachusetts

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

STEPHEN F. LYNCH, Massachusetts

JIM COOPER, Tennessee

GERALD E. CONNOLLY, Virginia

MIKE QUIGLEY, Illinois

MARCY KAPTUR, Ohio

ELEANOR HOLMES NORTON, District of

Columbia

PATRICK J. KENNEDY, Rhode Island

DANNY K. DAVIS, Illinois

CHRIS VAN HOLLEN, Maryland

HENRY CUELLAR, Texas

PAUL W. HODES, New Hampshire

CHRISTOPHER S. MURPHY, Connecticut

PETER WELCH, Vermont

BILL FOSTER, Illinois

JACKIE SPEIER, California

STEVE DRIEHAUS, Ohio

JUDY CHU, California

DARRELL E. ISSA, California

DAN BURTON, Indiana

JOHN L. MICA, Florida

JOHN J. DUNCAN, JR., Tennessee

MICHAEL R. TURNER, Ohio

LYNN A. WESTMORELAND, Georgia

PATRICK T. MCHENRY, North Carolina

BRIAN P. BILBRAY, California

JIM JORDAN, Ohio

JEFF FLAKE, Arizona

JEFF FORTENBERRY, Nebraska

JASON CHAFFETZ, Utah

AARON SCHOCK, Illinois

BLAINE LUETKEMEYER, Missouri

ANH ‘‘JOSEPH’’ CAO, Louisiana

BILL SHUSTER, Pennsylvania

RON STROMAN, Staff Director

MICHAEL MCCARTHY, Deputy Staff Director

CARLA HULTBERG, Chief Clerk

LARRY BRADY, Minority Staff Director

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C O N T E N T S

Page

Hearing held on June 17, 2010 ............................................................................... 1

Statement of:

Johnson, Hon. Henry C. ‘‘Hank’’, a Representative in Congress from

the State of Georgia; Hon. Bill Cassidy, a Representative in Congress

from the State of Louisiana; and Hon. Mike Honda, a Representative

in Congress from the State of California .................................................... 13

Cassidy, Hon. Bill ...................................................................................... 15

Honda, Hon. Mike ..................................................................................... 23

Johnson, Hon. Henry C. ‘‘Hank’’ .............................................................. 13

Koh, Howard K., M.D., M.P.H., Assistant Secretary of Health, U.S. Department of Health and Human Services, accompanied by John W.

Ward, M.D., Director, Viral Hepatitis Program, Centers for Disease

Control and Prevention, National Center for HIV/AIDS, Viral Hepatitis,

STD, and TB Prevention .............................................................................. 30

Mayer, Randy, chief, Bureau of HIV, STD, and Hepatitis, Iowa Department of Public Health, appearing on behalf of the Institute of Medicine;

Michael Ninburg, executive director, Hepatitis Education Project; Jeffrey Levi, executive director, Trust for America’s Health; and Rolf

Joachim Benirschke, former NFL place kicker, San Diego Chargers,

and spokesman for Hepatitis C awareness ................................................. 69

Benirschke, Rolf Joachim ......................................................................... 90

Levi, Jeffrey ............................................................................................... 83

Mayer, Randy ............................................................................................ 69

Ninburg, Michael ....................................................................................... 76

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

Benirschke, Rolf Joachim, former NFL place kicker, San Diego Chargers,

and spokesman for Hepatitis C awareness, prepared statement of ......... 92

Cao, Hon. Anh ‘‘Joseph’’, a Representative in Congress from the State

of Louisiana, prepared statement of ............................................................ 105

Cassidy, Hon. Bill, a Representative in Congress from the State of Louisiana, prepared statement of .......................................................................... 19

Connolly, Hon. Gerald E., a Representative in Congress from the State

of Virginia, prepared statement of .............................................................. 12

Honda, Hon. Mike, a Representative in Congress from the State of California, prepared statement of ...................................................................... 25

Issa, Hon. Darrell E., a Representative in Congress from the State of

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

Koh, Howard K., M.D., M.P.H., Assistant Secretary of Health, U.S. Department of Health and Human Services, prepared statement of ............ 34

Levi, Jeffrey, executive director, Trust for America’s Health, prepared

statement of ................................................................................................... 85

Mayer, Randy, chief, Bureau of HIV, STD, and Hepatitis, Iowa Department of Public Health, appearing on behalf of the Institute of Medicine,

prepared statement of ................................................................................... 71

Ninburg, Michael, executive director, Hepatitis Education Project, prepared statement of ........................................................................................ 78

Speier, Hon. Jackie, a Representative in Congress from the State of

CAlifornia, prepared statement of ............................................................... 103

Towns, Chairman Edolphus, a Representative in Congress from the State

of New York, prepared statement of ........................................................... 3

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VIRAL HEPATITIS: THE SECRET EPIDEMIC

THURSDAY, JUNE 17, 2010

HOUSE OF REPRESENTATIVES,

COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM,

Washington, DC.

The committee met, pursuant to notice, at 10:09 a.m., in room

2154, Rayburn House Office Building, Hon. Edolphus Towns (chairman of the committee) presiding.

Present: Representatives Towns, Kucinich, Clay, Watson,

Connolly, Quigley, Speier, Chu, Issa, Bilbray, Jordan, Chaffetz,

Luetkemeyer, and Cao.

Staff present: Kwane Drabo, investigator; Adam Hodge, deputy

press secretary; Carla Hultberg, chief clerk; Marc Johnson and

Ophelia Rivas, assistant clerks; Emily Khoury, professional staff

member; Kwame Canty and Gerri Willis, special assistants; Julie

Rones, counsel; Ron Stroman, staff director; Lawrence Brady, minority staff director; John Cuaderes, minority deputy staff director;

Rob Borden, minority general counsel; Jennifer Safavian, minority

chief counsel for oversight and investigations; Frederick Hill, minority director of communications; Adam Fromm, minority chief

clerk and Member liaison; Kurt Bardella, minority press secretary;

Seamus Kraft, minority deputy press secretary; Justin LoFranco,

minority press assistant and clerk; Ashley Callen, Sery Kim, and

Jonathan Skladany, minority counsels; Mark Marin, Molly Boyl,

and Meredith Liberty, minority professional staff members; and

Sharon Casey, minority executive assistant.

Chairman TOWNS. The committee will come to order.

Today’s hearing entitled, ‘‘Viral Hepatitis: The Secret Epidemic,’’

will examine the concerns about Hepatitis B and Hepatitis C as

raised by the Institute of Medicine in a recently released report.

That report, entitled, ‘‘Hepatitis and Liver Cancer: A National

Strategy for Prevention and Control of Hepatitis B and C,’’ indicates that the United States is experiencing a hepatitis crisis.

Many call hepatitis the silent epidemic because the attention it has

received has not been in proportion to the vast number of Americans it affects.

Hepatitis B and C are among the leading causes of preventable

deaths worldwide and are the most common blood-borne infections

in the United States.

The Institute of Medicine found that the current Federal approach to battling these diseases is simply not working. The IOM

Report suggests a greater need for a federally coordinated response

to these diseases, better surveillance, knowledge and awareness,

immunization and viral hepatitis services. Today’s hearing will reVerDate 11-MAY-2000 13:04 Feb 14, 2011 Jkt 000000 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 C:\KATIES\DOCS\62946.TXT KATIE PsN: KATIE
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view that report and will explore how to implement its recommendations.

Today I would like to welcome my colleagues who are helping to

focus much needed attention on these diseases: Congressman Hank

Johnson from the State of Georgia, Congressman Bill Cassidy from

the State of Louisiana, and Congressman Mike Honda from the

State of California. I would like to thank all of you for being here

today.

We are also joined today by Dr. Howard Koh, Assistant Secretary

for Health at the Department of Health and Human Services. He

is accompanied by Dr. John Ward, Director of the Viral Hepatitis

Program at the Centers for Disease Control and Prevention.

I thank all of our witnesses for being here today and look forward to hearing about progress on this issue, as well as how Congress can play a more pivotal role in making sure evidence-based

recommendations are implemented. I want to thank all of you for

being here.

At this time, I yield to Congressman Chaffetz from the great

State of Utah for his opening statement.

[The prepared statement of Chairman Edolphus Towns follows:]

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5

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Mr. CHAFFETZ. Thank you, Mr. Chairman, and thank you for

calling this hearing. This is an important, vital issue. I am proud

that this committee would actually bring this to our attention and

to hold this hearing. I want to thank the Members, the bipartisan

group of Members who are concerned about this issue. I would like

to associate myself with the comments that you made.

This is a huge issue; it affects Americans from coast to coast, it

affects the world, really, and it is something that we need to pay

a lot more attention to.

I would like to ask unanimous consent to enter into the record

the comments from the ranking member, Darryl Issa, as he had

some comments on this.

Chairman TOWNS. Without objection, so ordered.

[The prepared statement of Hon. Darrell E. Issa follows:]

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Mr. CHAFFETZ. And I would much rather hear from the panel

than hear from me, so, with that, I yield back the balance of our

time.

Chairman TOWNS. Thank you very much. I thank the gentleman.

The gentlewoman from California.

Ms. WATSON. Thank you so much, Mr. Chairman, for this exceedingly important subject-matter hearing on the secret epidemic of

viral hepatitis, affecting millions of Americans and their families

each year.

This hearing comes at a critical time: 1 in 12 people around the

world are affected by chronic and viral hepatitis, and it is one of

the most leading causes of preventable death worldwide.

In the United States, about 1,500 people die each year from liver

cancer or liver disease as a result of a hepatitis infection. But, if

we increase the amount of resources and awareness devoted to this

disease, many of those lives could be saved. Treatment does exist,

and it is more effective if the disease is caught early. But because

this disease is asymptomatic, as many as 75 percent of those infected do not know it until they have already developed liver cancer

or liver disease.

In response to this serious public health problem, the Institute

of Medicine was asked to provide insight into what opportunities

were being missed in relation to prevention and control of Hepatitis

B and Hepatitis C, and the IOM’s committee found that there is

a staggering lack of knowledge about chronic viral hepatitis among

health care and social service providers, at-risk populations, members of the public, and policymakers. And without proper knowledge, health care providers cannot sufficiently screen and treat

their patients, and Americans who may have the virus will not understand the dire need to get tested.

As a representative of California’s 33rd District in the city of Los

Angeles, I understand the impact these viruses have on individuals

and society, and also the disproportionate effect they have on certain minority communities. Chronic Hepatitis B is a leading cause

of death in the Asian and Pacific Islander community. African

Americans have the highest rate of acute Hepatitis B infections,

while Hepatitis C affects both African Americans and Hispanics at

the highest rate.

While I am pleased that the Obama administration has taken

the initiative to appoint Dr. Howard Koh as the Assistant Secretary of Health at the Department of Health and Human Services

with the specific task of developing a national strategy for hepatitis, our communities and the Federal Government cannot delay in

ensuring that they have sufficient culturally and linguistically sensitive access to prevention and treatment responses.

So I am looking forward, Mr. Chairman, to today’s witnesses and

to learn more about how we can start impacting and controlling

these vicious diseases. Thank you. I yield back.

Chairman TOWNS. I thank the gentlewoman from California for

her statement.

I now yield 5 minutes to Congressman Bilbray of California.

Mr. BILBRAY. Thank you, Mr. Chairman. Mr. Chairman, between

1985 and 1995, I had the privilege of supervising a county of 3 million, specifically part of the supervisor’s responsibilities in CaliforVerDate 11-MAY-2000 13:04 Feb 14, 2011 Jkt 000000 PO 00000 Frm 00013 Fmt 6633 Sfmt 6633 C:\KATIES\DOCS\62946.TXT KATIE PsN: KATIE
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nia’s public health, and this was the period when the hepatitis epidemic seemed to spread very quickly. The awareness, whatever we

can say on that. And with all the discussion that we had with HIV

and AIDS and all that other argument, the dirty little secret was

the huge impact on the general population, specifically the working

class population of the hepatitis problem.

And I just want to say clearly, as somebody who was able to be

briefed in that period, I think one of the untold stories in this country is that a whole lot of a certain segment of our community, and

it crossed racial lines, I think what happens is it is so much easier

to identify people based on the color of their skin, but not look at

their social economic group. That group, which includes a very

large percentage of the minority community, has been disproportionately impacted.

But there is a generational issue here. So I think with these

challenges we need to recognize that there are opportunities, and

I hope, as we address this issue, that we are not blinded by color

because it is easier to do that. We look at the fact that there is a

social economic group that truly is a rainbow coalition in the negative sense, but that it is also a generational challenge.

With these two challenges, we have opportunities. We have opportunities to focus resources, focus attention, and go directly, like

someone said, the laser beam toward a much more cost-effective

and much more humane approach to this issue.

I think the one thing that hasn’t been talked about in the last

year, when we talk about health care, is that hepatitis is the iceberg that is under the water that no one realizes that our health

care system is running full steam for. There is going to be an impact here that we are totally ignoring and is going to have a major

impact not just to the private sector, but to the public sector and

the community at large, and we ought to be addressing that.

There are opportunities coming down the line, in my opinion, to

be able to address this issue, address it with good science, good

medicine, and hopefully good politics, something we don’t see very

often in this town. But hopefully we can work together. This is a

bipartisan effort waiting to be done, and I hope that we join together to do it, Mr. Chairman.

Chairman TOWNS. I thank the gentleman from California for his

statement.

[Applause.]

Chairman TOWNS. Thank you very much.

Any other Members seeking recognition? Yes, the gentleman

from Virginia.

Mr. CONNOLLY. Thank you, Chairman Towns, and thank you for

holding this very important public health hearing. It is valuable because it increases awareness of the dangers of hepatitis while addressing some common misperceptions and related stigmas about

the strains of the virus.

5.3 million Americans are living with Hepatitis B or C, and an

estimated 75 percent of those are unaware of the fact they carry

the virus. Public education is essential. Between 15 and 40 percent

of individuals with hepatitis will delvelop liver cirrhosis if not

treated properly, making hepatitis the leading cause of liver transplantation in the United States. Viral hepatitis causes 12,000 to

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15,000 deaths annually, and approximately 20,000 people are

newly infected each year with Hepatitis C.

Responding to this immense public health threat requires a comprehensive approach that reduces the unconscious transmission of

hepatitis from mothers to children, while reducing the transfer of

Hepatitis C through needles associated with drug use.

Because hepatitis can go undetected for decades, many mothers

have no idea they are passing the virus on to their children. Asian

Americans are disproportionately affected by Hepatitis B. Approximately 1 in 12 carry the virus. My district is home to a diverse

Asian-American population. In fact, it is the largest single ethnic

group in my district. We need to ensure that our education efforts

are multilingual and address not just illegal drug or sexual transmission of this virus, but also the unconscious transmission from

mother to child, particularly for that more vulnerable population.

I look forward to learning more from the CDC at this hearing

about our efforts to arrest the spread of Hepatitis B among especially Asian Americans. Since there is an expected vaccine for Hepatitis B, we can make progress in reducing transmission rates.

Some individuals with Hepatitis C were infected over 30 years

ago, prior to proper sterilization methods of needles in medical settings. Others received the disease through illicit drug use. Today

we need to focus on drug suppression efforts and effective needleexchange programs that can and will reduce the incidence of Hepatitis C.

It is clear that the primary obstacle of reducing the spread of

Hepatitis B and C is a lack of Federal resources. In America’s five

largest cities, we provide only $90,000 annually for viral hepatitis

prevention. $90,000. We need to do much more to prevent the

spread of hepatitis, particularly because increasing the awareness

of the disease and increasing the use of the vaccine could and

would dramatically reduce rates of Hepatitis B and save lives in

America.

And, with that, I yield back.

[The prepared statement of Hon. Gerald E. Connolly follows:]

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Chairman TOWNS. Thank you very much. I thank the gentleman

for his statement.

Any other Members seeking recognition?

If not, we will move to our witnesses. We will now turn to our

first panel of witnesses. Congressman Hank Johnson from Georgia

has been a leading advocate in this Congress in pushing for more

attention to be paid to the serious health risk that hepatitis poses

to our Nation. It has become a personal battle for Congressman

Johnson and I am thankful he is willing to share his story with us

here today. Welcome, Mr. Johnson.

We also have with us today, Congressman Bill Cassidy from Louisiana. Mr. Cassidy has served his community for more than 20

years, helping to provide medical services for people in need. His

efforts in his community include setting up school-based health

programs to vaccinate children against the spread of Hepatitis B.

Welcome, welcome to the committee.

We also recognize Congressman Mike Honda, who has also been

very active in lending his voice to this issue by sponsoring legislation to help combat this critical health issue that affects so many

Americans. H.R. 3974, the Viral Hepatitis and Liver Cancer Control and Prevention Act of 2009, if passed, will support the comprehensive prevention measures that are called for in the IOM Report, as well as reduce the disease burden associated with viral

hepatitis.

I thank you all for being here today and I look forward to working with you. It is committee policy that all witnesses are sworn

in, so, Mr. Johnson, Mr. Cassidy, and Mr. Honda, if you would

stand and raise your right hands.

[Witnesses sworn.]

Chairman TOWNS. Thank you very much.

Let the record reflect that they all answered in the affirmative.

Why don’t we start with you, Mr. Johnson. You know the rules;

you know the clock. But we are not even going to turn it on; we

are going to leave you with it, because you know the rules. OK?

[Laughter.]

So we are going to come right down the line, Representative

Johnson, then Representative Cassidy, and then Representative

Honda. Thank you.

Representative Johnson.

STATEMENTS OF HON. HENRY C. ‘‘HANK’’ JOHNSON, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF GEORGIA;

HON. BILL CASSIDY, A REPRESENTATIVE IN CONGRESS

FROM THE STATE OF LOUISIANA; AND HON. MIKE HONDA, A

REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA

STATEMENT OF HON. HENRY C. ‘‘HANK’’ JOHNSON

Mr. JOHNSON. Thank you, Chairman Towns and Ranking Member Issa, for holding this hearing today. I applaud the committee

for showing leadership on preventing and controlling hepatitis infections by holding this hearing on the Federal Government’s response to the viral hepatitis epidemic in this country.

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As many of you may know, last year, I announced that I was on

a robust course of treatment for Hepatitis C. Today I am back. I

am alive, I am feeling great, feeling strong and, in the words of

James Brown, I feel good. [Laughter and applause.]

I stand here today bolstered by the love and prayers that I have

received from family, constituents, and colleagues. I hope that my

disclosure last year will provide others suffering from hepatitis

with confidence to speak out and educate the community about this

illness. I am testifying today because I know from firsthand experience just how devastating these hepatitis viruses can be on Americans. I am one of the lucky ones who found out I was infected, had

insurance, and was able to receive treatment.

A few important facts that I want the committee to be aware of.

First, two-thirds of Americans infected with hepatitis are unaware

of their infection, leaving them unable to take action to protect

their health and the health of others. Second, the only dedicated

Federal funding for hepatitis is $19.3 million per year for the CDC.

This is not enough and pales in comparison to funding for other infectious diseases. Considering these two facts, it is clear that the

Federal Government has failed in its response to hepatitis, and I

am hopeful that this hearing can bring about a period where this

trend is reversed.

Unlike the majority of people living with infection, I actually do

know my status. The vast majority, with estimates as high as 75

percent, do not know that they are infected with hepatitis, the

leading cause of liver cancer in America.

A recent Institute of Medicine report on liver cancer and hepatitis found that health providers neither screen nor test for hepatitis, even for patients at risk. I am grateful to have the support

of my family and friends, my colleagues and my staff. However,

those who test positive often feel stigmatized, making it difficult to

encourage people to know their status and get treatment.

As with other infectious diseases, a proper and effective government response will lessen the stigma associated with the illness. It

is important to note that even with the passage of health care reform, I am concerned that Hepatitis B and C will and can still impact those who have limited access to health care, such as injection

drug users, the homeless, certain racial and ethnic minorities, legal

immigrants living in poverty, and undocumented immigrants.

As a member of the Congressional Black Caucus, I want the committee to know that rates of Hepatitis C are twice the national average among African Americans. In fact, 1 in 10 African Americans

between the ages of 40 and 60 are estimated to have Hepatitis C.

I want to say that once again. In fact, 1 in 10 African Americans

between the ages of 40 and 60 are estimated to have Hepatitis C.

As we all know, African Americans are less likely to have access

to adequate health care and would be positively impacted by an improved government response to viral hepatitis. Further, the babyboomer population is estimated to account for two out of every

three cases of chronic Hepatitis C. As these Americans continue to

age, they are likely to develop complications from Hepatitis C and

cost Medicare billions in treatment, transplantation, and palliative

costs. We can and should do something about this epidemic.

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I can tell you, Representative Bilbray, that the persons who I

enumerated as being at risk are not, as you say, as you pointed

out, they are not limited to minorities. There are substantial numbers of Caucasians who are afflicted with this chronic ailment, and

some I have been working with diligently in the private arena to

bring attention to this very serious disease.

We can do better for all Americans at risk for and affected by

viral hepatitis. With scant Federal resources, lack of program coordination, and the absence of political will, Americans have continued to develop liver cancer and associated lethal complications

of viral hepatitis because of our inaction with regards to these preventable infections.

There have been some positive steps, however. Representative

Mike Honda has introduced legislation, which I support, to authorize a comprehensive prevention, education, research, and medical

management referral program to reduce the disease burden associated with these costly and lethal infections. This bill, the ‘‘Viral

Hepatitis and Liver Cancer Control and Prevention Act,’’ H.R.

3974, is also supported by Chairman Towns, and I want to thank

the chairman for his support for this important bill.

In addition to these efforts, we need to increase funding for viral

hepatitis prevention. Despite dealing with an epidemic that the

CDC estimates afflicts 5 million people, the division of viral hepatitis is the smallest funded infectious disease division under the

National Center for HIV, Viral Hepatitis, STD, and TB Prevention.

At $19.3 million, viral hepatitis receives only 2 percent of the Center’s total annual budget. Funding must be increased to the division of viral hepatitis so that the division can mount an effective

prevention response and begin funding preventative services.

We must ensure that other funding streams support this work,

especially as health reform authorizes new moneys for prevention.

I am excited about the prospects of Dr. Howard Koh’s interagency

working group on hepatitis and the development of an HHS national plan on hepatitis. I hope that this workgroup will receive

adequate resources and that, through this workgroup, real and effective work can be done to forge a national strategy to combat

hepatitis.

Thank you for holding this very important hearing today and for

allowing me to address this committee. I look forward to a very

productive and robust hearing on investigating the Federal response to viral hepatitis, and I yield the balance of my time.

Chairman TOWNS. I thank the gentleman from Georgia for his

statement.

I now yield time to Representative Cassidy. You are on Appropriations, aren’t you?

Mr. CASSIDY. I wish. [Laughter.]

But, no.

Chairman TOWNS. Representative Cassidy.

STATEMENT OF HON. BILL CASSIDY

Mr. CASSIDY. Thank you Chairman Towns and Ranking Member

Issa, and other members of the Committee on Oversight and Government Reform for calling this hearing. For the last 20 years, I

have been a doctor. I am a hepatologist. A hepatologist is a doctor

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who treats liver disease. So it is kind of a confluence of my career

to be here in a political life to discuss this. I still treat patients in

a public hospital back home, and I can, from my personal experience, verify this affects a cross-section of people; from folks who are

homeless to folks who are nuns, folks who are bankers and teachers, folks who are somewhere at a more humbler economic station.

And yet they all have a common need, and that is to be treated or

comforted.

Now, among my clinical activities, as you mentioned, Mr. Chairman, was founding the Greater Baton Rouge Community Hepatitis

B Vaccination Program. For over 6 years, we vaccinated 36,000

kids to prevent Hepatitis B over a 10-parish area. Now, what

caused me to do that program was an 18-year-old who came to the

Intensive Care Unit. They called me in the middle of the night. She

was dying from Hepatitis B.

In the middle of the night, we helicoptered her out to a transplant center in Shreveport, LA, and there to receive a transplant

that would cost $200,000 to $400,000 and, if successful, it would

cost $30,000 every year thereafter to care for her with the medication and treatment. And I thought to myself, we are going to spend

$1 million over the course of her lifetime, when a $50 vaccine

would have prevented this. For the amount that we are going to

spend for this young lady, I could have vaccinated everybody in my

community. So that is what we attempted to do.

Now, let’s give credit where credit is due. The way we were able

to do that in this public-private partnership is that President Clinton proposed the Vaccines for Children’s Program, and Congress, in

its wisdom, funded it. So, thereby, the biggest cost item, if you will,

which is vaccine, we were able to get from the Federal Government

and then, through a public-private partnership, vaccinate 36,000

children.

Now, I am a teacher, so let me pause for a second. I assume everybody has my knowledge, but I have been studying this for 20

years. ‘‘Hep’’ comes from the Greek word for liver; ‘‘itis’’ means inflammation. And viral hepatitis is just inflammation of the liver

caused by a virus, Hepatitis B and C being those causing chronic

hepatitis most commonly. And, folks, asked the difference between

Hepatitis B and C, I say it is like the difference between a dog and

a cat: they look alike, superficially they are the same, but in reality

they are two different animals. Hepatitis B and C are two different

animals, so to speak.

And they have different ways of being transmitted. Hepatitis B,

I like to say to my students, so they remember, is spread by blood,

birth, and body fluids. So it is spread when a momma gives birth

to her baby. If the momma is infected, the virus passes as the child

goes through the birth canal; the child is infected from the

momma’s body fluids. It can also be spread sexually, spouse to a

spouse, if you will, and also by blood. So B, B, and B.

Hepatitis C is spread by blood, primarily. Now, there is a medical

word for blood cells called corpuscles, so if you are one of my students, I would say C stands for corpuscle. You can remember it is

spread by blood.

Now, in the case of B, commonly, it is spread mother to baby.

But also it can be spread from ages 15 on because that is, one,

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when kids or adults become sexually active and marry, but it is

also when they engage in other high-risk activities. For the Hepatitis C, it is typically spread when someone gets, in times past, a

blood transfusion. So momma gives birth to a baby; a Vietnam soldier gets shot and gets transfused; they get infected.

And it doesn’t necessarily cause a problem right away. What hepatitis does, the ‘‘itis,’’ the inflammation is almost like a pimple inside the liver. A little pimple that goes away. But if you have lots

of little pimples, you have little tiny bits of scar tissue that buildup. Now, over the course of a year that is not going to be enough,

but over the course of 15 to 30 years those little pimples are all

over the place in the liver, which go away but leave a little bit of

scar tissue, cause so much scar tissue that the liver no longer functions.

I like to point out I have a scar on my wrist. That scar on my

wrist does everything I want. I wish I could slam dunk a basketball, but, if I wanted to, it could do that. But we have all seen

someone whose arm has been burned, covered with scars, so their

arm doesn’t work like ours does; it works more like a club, it loses

function. Similarly, as the liver is progressively scarred, a little bit

of scar doesn’t make a difference; progressive scarring inhibits the

liver’s ability, just like it does an arm, to function as it should.

Now, I go through that to first say that, as Representative Johnson said, most people who have Hepatitis C look like us, men who

are in their fifties, maybe early sixties. Now, as it turns out, we

have a graph from the table here in our handout, most folks were

born between 1950 and 1959, the 1960 through 1969. Now, remember, these little bit of inflammation leading to a little bit of scar

tissue slowly accumulating over decades, and folks pick it up when

they are 20 to 25, typically, as it slowly builds up, it means the

crest of the wave is about to hit.

As Congressman Bilbray spoke, we have this iceberg that is

about to impact. So everybody has been picking up this little bit

of scar tissue, don’t know about it and, boom, if you look on this

page of our graph, you will see that as these areas get bigger, we

can look at the cost that is going to increase because folks who are

not so fortunate as to be treated and cured are now 55 years old,

being diagnosed with Hep C, coming to the hospital to be treated

by someone like me. That hospitalization costs $30,000 to $100,000

per hospital stay; they get referred for a transplant, and that is

$200,000 to $400,000. Sounds a lot like that 18-year-old I saw in

the ICU.

Now, to put a kind of more statistical point on it, the Milliman

report says that health care costs for these patients will more than

double over the coming years; the per patient cost of treating patients with Hep C will increase 31⁄2 times over 20 years, because,

again, we have had it for a while; we are starting to have more

complications. In 10 years, the commercial and Medicare cost for

treating hepatitis patients will more than double, and in 20 years

our Medicare cost for treating patients with Hepatitis C, this is the

iceberg hitting, will go up fivefold.

What is that cost? Well, if we treat somebody proactively with a vaccine for Hepatitis B, it is $50 for the vaccine. If you are going

to treat somebody who has chronic Hepatitis B, it is $2,000 to

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$16,000 per year; for Hepatitis C it is $15,000 to $25,000 a year.

But the medical costs of Hep C, as we mentioned earlier, are expected to increase from $30 billion to $85 billion between now and

2024, principally because those infected in the sixties are now suffering the consequences of that infection.

So what should be done? That will be elaborated on later on, but

I can tell you from my experience: education, education, education.

You educate doctors to screen; you educate patients to get checked;

you educate spouses of patients as to what this means for their

family.

Vaccination. For Hepatitis B there is a vaccine; for Hep C not.

We have done a very good job with children. We need to do a better

job with adults, because there are folks at high risk who are not

getting vaccinated for Hepatitis B. In terms of Hep C, ideally, a

partnership of academia, industry, and government could come up

with a Hep C vaccine. We need to think better how to integrate

these services into the care we already provide.

We went to schools because we knew that the rate limiting step

for getting the child vaccinated was the fact that the momma was

working full-time and couldn’t get off of work to take her baby in

to get vaccinated three times. So we brought the program to the

schools so the momma didn’t have to miss work and, thereby, we

were able to vaccinate all these children.

So let me finish by saying, again, thank you for inviting me

today. Now, today I praised the Vaccines for Children Program

which this Congress, in its wisdom, passed way back when. It is

my hope that in 20 years there will be another hepatologist, she

will be sitting here and she will be praising the wisdom of this

Congress because we put in a bill that, just as the Vaccines for

Children Program enabled me and our team to save lives, so what

we do in this bill will enable her, as she practices over the next

20 years, to similarly save lives or to make them healthier.

Again, thank you.

[Applause.]

[The prepared statement of Mr. Cassidy follows:]

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Chairman TOWNS. Thank you so much for your testimony. Thank

you. Thank you very much.

Representative Honda.

STATEMENT OF HON. MIKE HONDA

Mr. HONDA. Thank you, Chairman Towns and members of the

committee, for inviting us today to testify on viral hepatitis. As you

can tell, we have very passionate testimony here by folks who personally have been involved with it or have worked on it as a professional hepatologist, one who studies. It is good to have a doctor in

the crowd.

I just want to acknowledge Congressman Johnson, Dr. Cassidy,

Congressman Cassidy, Assistant Secretary Koh and Dr. Ward for

joining us here today. In the presence of so many members and

leaders within the health community underscores the importance of

this issue and we know that is not a new issue, it is one that has

been outstanding for a long time. So, Chairman Towns, it is really

an opportune time to bring all this together.

I do want to make a shout out for the Tri-Caucus and their effort

in the health bill to make sure that the health disparities have

been included in the health bill also to address some of the concerns that some Members have had.

As we know, viral hepatitis is highly infectious. For example,

Hepatitis B virus is 100 times more infectious than HIV because

so many people, as has been said before, are unaware that they

have the virus and continue to spread it. An estimated 5.3 million

people are infected with either Hep B or C and, tragically, more

than half are unaware of their status and, for those reasons, it is

100 times more infectious than HIV. And many more have called

this the silent crisis, but, as we can tell today, we are not about

to be silent anymore and we are not going to be silent on this issue.

The chronic Hep B and C are expected to cost at least $20 billion

over the next 10 years. In fact, the total medical cost for patients

with Hep C infections are expected to increase more than 21⁄2 times

that, as was said before, from $30 billion to over $85 billion over

the next 20 years. And with the bill that we have, H.R. 3974, over

the next 5 years we intend to make available $600 million to move

forward on this effort to avoid and prevent the spread of Hepatitis

B and C. And I am sure with the help of Dr. Koh and his interagency work, the money will be well used and come up with a very

comprehensive plan and strategy.

So we need to change the way hepatitis is diagnosed and treated.

Our current structure, as we can tell, cannot be sustained if we

continue down this path.

So from the Institute of Medicine, they released a report on hep

and liver cancer with the crucial recommendation for a national coordinated strategy for prevention and control, and I believe Dr.

Koh will speak to that. Their recommendation is calling for CDC

to work with State and local health departments to develop a new

model for surveillance, and probably the model shouldn’t be called

new because it has been implemented in various places in this

country through folks like Dr. Cassidy and some folks in the State

of California have developed kinds of models working with children

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and schools. So there are a lot of things out there that can be

brought together.

And with the help of the chairman and Congresspersons Cassidy,

Johnson, and Dent, we, together, introduced H.R. 3974, and it

should mirror all of the recommendations from the Institute of

Medicine and it brings together the common concerns of the diverse

viral hepatitis community to fight this chronic viral hepatitis by establishing, promoting, and supporting a comprehensive prevention,

research, and medical management referral program.

The bill will strengthen the ability of the CDC to support State

health departments in prevention, immunization, and surveillance

efforts, and through this legislation and with strategic investments

in public health and prevention programs billions of dollars can be

saved, as has been said before, and tens of thousands of people in

States and cities all over this country can improve.

It doesn’t stop here, though, Mr. Chairman. It continues to be a

global issue also, and I think that we can work with other countries who have made great strides in Hep B and C and other arenas, along with HIV/AIDS. It seems to me that, as we move forward, the synergy of both efforts globally will probably be able to

be more efficient and address this problem globally, but we have

to start here at home.

So I can tell by the testimony from members of the committee

and yourself, Mr. Chairman, and the folks here that we are committed and we are determined to make sure that we address this

and conquer this ravaging disease.

One of the things that we could probably look at as Members,

different Members across this country, is to host health fairs in our

communities. It has been done in San Francisco. I took part in

that. I was a little anxious. You really don’t want to find out

whether you are sick or not, but I was more afraid that I might

be sick, so that greater fear drove me to participate in the health

fair in San Francisco. Mayor Newsome, Assemblywoman Fiona Ma

and myself, we participated in that.

Newsome is fine. I was reported out as negative, so I continue

my treatment for the next two immunizations. Three steps, actually. Currently, I guess I am in a safe zone, if you will. But this

should be replicated for every citizen and every child in this country. Fiona Ma, we know today, is a carrier, but it is under control.

So these are the kinds of things we need to do immediately, that

we can do as Members of Congress, to sponsor these health fairs

in the neighborhoods that we live and work in.

So I just want to commend you, Mr. Chairman, and the members

of the committee for holding this important hearing so that we can

move forward with knowledge, determination, and resources. I

thank you very much.

[Applause.]

[The prepared statement of Hon. Mike Honda follows:]

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Chairman TOWNS. I thank you. Thank you.

Let me indicate that I look forward to working with you. I think

that your coming today and sharing your personal experiences and,

of course, doc, your being involved in this over the years and Representative Honda, in terms of your work, I want you to know that

I am committed to working with you to try and do much better.

I think that one thing that we need to do, and the reason I asked

you, Representative Cassidy, because I am looking for some appropriators. You know, we need some money. That is key to be able

to address the problem. I think it is a disgrace to have a problem

of this nature and not to focus on it in terms of resources, because

we know that if we put enough resources to it, that we will be able

to do a whole lot better than what we are doing now.

Mr. Johnson, Congressman Johnson, I am happy to note that you

feel good, but we want to make certain that some other folks also

feel good, and I think the way to do that is to have the resources

to address it.

At this time I would like to yield to——

Mr. HONDA. Mr. Chairman, before you close, just for the record,

I am not Daddy Warbucks, but I do sit on Appropriations. So you

will find colleagues in support there.

Chairman TOWNS. Right. Thank you very, very much. We appreciate that.

Let me just yield to the ranking member of the full committee,

Congressman Issa from California.

Mr. ISSA. Thank you, Mr. Chairman. I thank you all for your indulgence. Obviously, with the conference on financial reform, a lot

of us are going back and forth.

What I am concerned about is, if I have two appropriators here,

where do I get a budgeteer so that we get this properly in the

budget? That may be something for you and for all of us here at

the dais. At a minimum, we need to have at least a partial budget

that looks at these kinds of items. And I will speak as a Republican

for a moment for only one moment: I cannot and will not do earmarks by act of our conference. So we cannot fund these kinds of

programs in specificity, no Republican can, unless they are in the

budget or in some other way not an earmark.

So I am totally supportive. I believe that to not spend $35 million, we should spend millions in prevention. There is no question

that we need to address this informationally in a prevention basis,

but I would hope that all of us here, since this is a Members’ hearing, realize that even if we can’t do a full budget, we need to take

the President’s budget, we need to work it as to some of these

issues, and we need to make sure that we get it passed so that Republicans and Democrats can vote on that portion of the budget.

So, Mr. Chairman, I look forward to working with you on that.

It is very clear that this is a problem that should not wait until

the next budget cycle.

I yield back.

Mr. HONDA. Mr. Chairman, if I may.

Chairman TOWNS. Yes.

Mr. ISSA. Reclaiming my time. Mr. Honda.

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Mr. HONDA. If you would yield. You can help. We probably don’t

need an earmark, but we do have a bill that you can join us on,

H.R. 3974.

Mr. ISSA. That directs the CDC.

Mr. HONDA. It does that and also provides funding for the next

5 years.

Mr. ISSA. That is an earmark. That is one of our problems. Directing specific spending is one of our challenges right now. Look,

I have a million pet projects. There is no question at all, we all do.

But one of our challenges is to get a budget and work through this.

I support the authorization, but authorization that directs specific

action crosses the line right now, and the American people agree

with us that we need to do it in a formalized fashion. Now, the

truth is the President has presented us a budget that we should

be acting on, and that is my frustration: the President has done his

job; we haven’t done ours.

Anyone else?

Mr. HONDA. I didn’t know that my bill was an earmark.

Chairman TOWNS. No, I wouldn’t say it is an earmark. I think

that what we need to do is find an offset, and one way to find it,

I think that we might be able to look at the military budget, now

that there are some changes there. Maybe we can find the money.

An offset is what we really need. So we want to make certain that

we get it.

Mr. JOHNSON. Would the gentleman yield?

Chairman TOWNS. I would be delighted to yield to the gentleman,

then I will go to the gentleman from Illinois.

Mr. JOHNSON. Thank you. I know that there are many people

who are viewing this and they don’t really understand the difference between earmarks and items that are lodged in the budget

and that are paid for or not paid for. They don’t understand all of

that, they just know that they are not feeling good, they need help,

and they don’t want to see others go through what they have had

to endure.

So I just want to say that these are issues, Representative Issa,

that you have pointed out, and I think that they can all be worked

out. We just have to have the will to work them out, and we will

find the money to get this done. That is my hope and prayer, that

we will be able to make some inroads based on this hearing.

Mr. ISSA. And, Mr. Chairman, I concur with the gentleman. Mr.

Johnson is right that we need to find the money; this is a legitimate priority. And I agree with you that if we can find an offset,

after all, we are spending a trillion more than we are taking in.

There ought to be something in that trillion of excess spending that

would allow us to cut here to do a priority, and I look forward to

working with the gentleman on it.

Chairman TOWNS. Thank you very much.

I now yield to the gentleman from Illinois.

Mr. QUIGLEY. Thank you, Mr. Chairman. I just had a question

for the doctor.

Doctor, you talked about education, but you or I go in to a routine physical and have blood tests. Don’t they normally screen for

hepatitis?

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Mr. CASSIDY. Not necessarily. The way that hepatitis is typically

picked up is through a preemployment physical or through an insurance physical. So you and I, kind of middle-class guys, want to

up our insurance. As it turns out, with Hepatitis C and Hepatitis

B, but particular Hepatitis C, your liver enzymes could be normal,

so you don’t always have the elevated enzymes that would be the

tipoff even if they were to be checked.

So partly you just have to have it on your checklist of questions

to ask. Have you ever had a blood transfusion? Have you ever had

a tattoo which was not with a sterile needle? In your younger, wilder days, did you ever do anything that you are currently ashamed

of, which most people raise their hands if you ask that question

delicately. [Laughter.]

Mr. QUIGLEY. Not me.

Mr. ISSA. I don’t get it. What good would that do? It is 100 percent.

Mr. CASSIDY. Well, Bilbray is waving both of his hands.

But with that sort of questioning you can then find out that, you

know, I did live in Thailand; I got some tattoos when I was in the

Army, and we know that Thailand has a lot of hepatitis. So that

would screen someone to say, oh, let’s check them, sort of thing. So

there are ways, specific questions you can ask to get a question to

go on to further testing.

Mr. QUIGLEY. How much further testing does it take?

Mr. CASSIDY. Not much. A simple blood test. There is a Hepatitis

C antibody which is going to be positive in about 99.9 percent of

the people that have it.

Mr. QUIGLEY. But if the normal blood test just picks up the elevation, how much more does it cause, given the extraordinary cost

involved with this, with just checking for it in the first place?

Mr. CASSIDY. You could, and the people from Hepatitis C probably have run models on that. If there is a prevalence of about, oh,

2 percent in the population, then you would have to say, OK, we

are going to run 100 tests in order to get 2 percent positive. Now,

for those 2 percent it can be a game changer, but if you put it in

a spreadsheet it may turn out that your cost per detection is too

high.

And I will defer to the folks from the CDC because I suspect they

run these models. On the other hand, if you want to say we are

going to take every guy that was born between 1950 and 1965,

then you are getting to the people that have the higher prevalence

rate; and I suspect those sorts of recommendations have been considered. So that would be, if you will, a target-rich environment.

Mr. QUIGLEY. Thank you.

Mr. JOHNSON. Would the gentleman yield?

Mr. QUIGLEY. I yield back.

Chairman TOWNS. I will yield for comment, yes.

Mr. JOHNSON. Thank you, Mr. Chairman.

In my own case, back in 1998, my wife noticed that I was just

sleeping too much and just really tired, and I noticed it also, but

it got to a point where she decided that, hey, you need to go to the

doctor and get this checked out. So based on the feeling that I was

just worn down and, you know, no matter how much sleep I got,

I would still wake up and 5 minutes later I am ready to go back

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to bed, and could go back to bed and go to sleep. So my doctor was

inquisitive enough to check for Hepatitis C, and that is how we discovered that I had this virus.

And I would point out to people that it is not only those who may

have engaged in some kind of high risk activity like intravenous

drug use or had a transfusion or got a tattoo. It could have been

contracted by someone who went into a dental office or a medical

office that, at the time, may have sterilized needles and used them

again, or sterilized syringes and used the syringe again, throwing

away the needle, and perhaps it could have happened in that way;

or in a hospital when you went in and had to get blood drawn or

whatever the case might be. Risky procedures back then could have

led to the infection.

But I think it is important to note that it is not really important

how the disease was contracted; the main thing is do you have it

and can you eliminate it so that you can live a long, happy, and

prosperous life. So I would like to encourage anyone who feels that

they may have been affected or they may be infected to ask your

doctor to check for hepatitis in the blood. Also, last but not least,

one needle, one syringe on one person is the name or the motto of

an organization. I am sure that they are represented today here.

But one syringe, one needle, one person. Thank you.

Chairman TOWNS. Let me thank all of you for your time; you

have been very generous with it. I want to thank you and indicate

again that I look forward to working with you. We can do a whole

lot better than what we are doing. Thank you very, very much.

[Applause.]

Chairman TOWNS. I ask the second panel to come forward. That

panel includes Dr. Howard K. Koh, Assistant Secretary for Health,

U.S. Department of Health and Human Services. He is being accompanied by Dr. John Ward, Director of the Viral Hepatitis Program at the Centers for Disease Control and Prevention in Atlanta.

Let me administer the oath.

[Witnesses sworn.]

Chairman TOWNS. Let the record reflect that both answered in

the affirmative.

You may be seated.

Dr. Koh, I will ask you to summarize your testimony in 5 minutes. As you are aware, the committee members may ask questions

of both of you who are able to respond based on the fact that both

of you have been sworn in. So, Dr. Koh, you may continue.

STATEMENT OF HOWARD K. KOH, M.D., M.P.H., ASSISTANT SECRETARY OF HEALTH, U.S. DEPARTMENT OF HEALTH AND

HUMAN SERVICES, ACCOMPANIED BY JOHN W. WARD, M.D.,

DIRECTOR, VIRAL HEPATITIS PROGRAM, CENTERS FOR DISEASE CONTROL AND PREVENTION, NATIONAL CENTER FOR

HIV/AIDS, VIRAL HEPATITIS, STD, AND TB PREVENTION

Dr. KOH. Good morning, Chairman Towns, Ranking Member

Issa, and distinguished members of the committee. I am Dr. Howard Koh, the Assistant Secretary for Health at the Department of

Health and Human Services, and I am deeply honored to be here

today to discuss the silent epidemic of viral hepatitis and also to

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review the coordinated steps of the Department with respect to addressing this major public health challenge.

I am also deeply grateful to our colleague, Dr. John Ward, from

the CDC, who is here to my right. Dr. Ward is the Director of the

Division of Viral Hepatitis and also an international expert in this

area.

You have heard and let me quickly review the key facts of this

epidemic, and the burden that weighs heavily on our society. Estimates are that up to 5.3 million Americans have chronic viral hepatitis. Annually, there are an estimated 43,000 new cases of Hepatitis B and an estimated nearly 20,000 cases of Hepatitis C. Viral

hepatitis causes up to 15,000 deaths each year, and as a physician

who has cared for patients for over several decades, I have seen for

myself the impact of this condition on patients and families.

Of great concern is that illness, death, and cost from this disease

are all expected to rise substantially in the future, in part because,

of those infected, a vast majority, up to 75 percent, are not aware

that they have Hepatitis B or Hepatitis C. Moreover, of those who

are aware, not enough are in care or receiving appropriate treatment.

As you have heard from the previous panel, Hepatitis B and C

infections often persist for years, cause chronic liver inflammation,

scarring, cirrhosis, and, most devastatingly, liver cancer. In fact, in

contrast to almost all other types of cancer, liver cancer rates have

tripled over the last several decades, fueled in large part by chronic

hepatitis infection. In the absence of appropriate treatment, up to

40 percent of infected persons will develop liver cirrhosis and, very

tragically, viral hepatitis is the leading cause of liver transplantation in the United States.

In the face of this, the CDC has recommended screening to identify persons with viral hepatitis and also recommends prevention

and care services. I will be saying more about that in just a second.

We are grateful as a country that we have safe and effective vaccines to protect against Hepatitis B. For Hepatitis C, there is no

vaccine, but prevention can play a significant role to reduce new

cases.

Moreover, prevention and care for viral hepatitis makes great

economic sense. Published studies show that the cost for viral hepatitis can run in the billions of dollars per year, so the benefits of

a better public health approach are enormous. And, as a physician

who is trained in cancer, I am particularly eager to pursue the concept of hepatitis prevention as a new form of cancer prevention,

and that is some of the education we would like to do moving forward.

As you have heard, in January 2010, the Institute of Medicine

came out with a new report documenting very low levels of awareness and knowledge of viral hepatitis both at community and provider level, and this report documented inadequate investments in

prevention and care services and fragmented and poorly developed

surveillance systems.

Our Department of Health and Human Services and its agencies

are fully committed to the prevention of hepatitis and fully committed to the care of infected individuals, so, in January, as the Institute of Medicine was coming out with its report, the Department

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established a new interagency workgroup, which I chair, and this

workgroup has broad representation from all the major agencies

throughout the Department.

We have started in on the very important work of drafting a

comprehensive strategic plan for the Department to improve coordination of prevention, care, and surveillance activities, and we are

focused on five major goals: first, to increase community awareness

and provider education; second, to strengthen surveillance; third, to

improve vaccination for Hepatitis B; fourth, to prevent transmission; and, fifth, to improve clinical preventive care and treatment services.

We have an excellent interagency working group and I am very

proud of its members, and we are on a time line to complete an

action plan by October 1st of this year. We are motivated by the

fact that we have effective public health measures to prevent transmission, and these measures have already helped our Nation

achieve remarkable declines in the numbers of new infections from

both Hepatitis B and C.

For example, as we have mentioned, now we have safe and effective vaccines for Hepatitis B, and State and local perinatal prevention activities have a proven track record of success and can help

eliminate Hepatitis B in newborns in our country. In the past,

while cost has been a potential barrier for adult immunization,

health reform now provides new opportunities to increase immunizations recommended by the Health and Human Services Advisory

Committee on Immunization Practices [ACIP].

With respect to Hepatitis C, we need more research on an effective vaccine, and that is a continued priority for the country. In the

meantime, other new prevention tools must be developed and implemented. This includes refining and adapting HIV prevention

strategies to also include Hepatitis C; testing and counseling to increase awareness; improving awareness of infection status will also

promote safer behavioral practices; we also need better methods to

reduce transmission risks in health care settings, and you have

heard a lot about that already; and also new and improved therapies. We are encouraged that we have treatments that can result

in viral clearance and halt liver damage caused by chronic viral

hepatitis.

A key area here is that since millions of Americans are unaware

that they have this potentially life-threatening disease, we have as

a major goal to raise awareness, to test high-risk persons, increase

the number of people who know their status, and link people to

preventative and care services. And we are very sensitive about the

fact that there are many communities who are experiencing health

disparities, and we need culturally appropriate education programs

that can increase awareness of this epidemic, increase awareness

about the health benefits of vaccination and prevention, and also

discuss the need to reserve stigma.

For providers, education can increase understanding of screening

and vaccination policies; help with the interpretation of laboratory

tests and management of care and treatment; and we also seek to

help providers with respect to integrating viral hepatitis services

with other appropriate prevention services for HIV, for sexually

transmitted disease, and other conditions. We also want to work to

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connect clinicians and broader public health surveillance activities

so we can advance monitoring and case management.

Our Department’s interagency workgroup is also examining ways

to enhance that surveillance, and currently the CDC estimates that

only about 10 percent of new cases of viral hepatitis are reported

each year. Two-thirds of States report cases of chronic Hepatitis C,

but those that do have large backlogs of uninvestigated cases, so

a clear picture of the nature and scope of chronic Hepatitis C in

particular across every State is not readily available.

So we plan to have better integration with respect to monitoring

hepatitis and then implementing prevention and care programs.

We also want to address the disparities issue, especially how this

condition affects Asian-American and Pacific Islanders and African

Americans and at-risk populations such as the homeless, immigrants, injection drug users, and incarcerated persons.

So, in summary, Mr. Chairman and distinguished committee

members, we are very, very grateful to you for holding this hearing. We all agree on the tremendous burden of this disease on our

society. I want to assure you that our Department has taken immediate and coordinated steps to reverse the trends that are before

us. We want to work closely together with you and we have a

major opportunity with respect to prevention and creating new systems of care.

Again, I want to thank my colleague, Dr. Ward, who has done

so much critical work in this area. And I would be very happy to

take any questions. Thank you.

[The prepared statement of Dr. Koh follows:]

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Chairman TOWNS. Thank you very much for your testimony. We

really appreciate your being here.

Based on what you have seen, read, and heard, if we have the

resources, can we prevent hepatitis?

Dr. KOH. Mr. Chairman, I think the potential for prevention here

is unlimited. We understand risks and we understand the trends

if we don’t act, so we have a great opportunity right now with your

leadership and the work of your committee.

Also, I should stress that with the passage of health reform we

have an opportunity to talk about true systems of care and a renewed emphasis on prevention. Prevention involves not just work

in a clinic, but also in a community. And in this particular case

prevention also focuses on immunization strategies as well. So we

have tremendous opportunities right now.

Chairman TOWNS. Dr. Koh, if people don’t feel sick and don’t

know they are sick, how can we go about identifying those who are

infected?

Dr. KOH. That is the challenge, Mr. Chairman, of screening

asymptomatic people, and that is the challenge of prevention,

which we are facing much better as a Nation. We have much more

commitment and attention from policymakers like yourself, members of the health community, and the general public to advance

prevention, testing high-risk groups, and screening. Again, through

health reform that has a great prevention focus. We need more attention to developing guidelines for screening and testing high-risk

groups, and then making those guidelines available for people to

understand, and then also covering prevention services so that cost

is not a barrier.

Chairman TOWNS. How bad is the problem of hepatitis?

Dr. KOH. We have heard the numbers over and over. Up to 5.3

million people infected right now. But the big challenge that up to

three quarters of the people who are infected are unaware they

even have the virus. So the challenge is catching it early for

asymptomatic people, spreading the message that we have good

treatments if cases are discovered early, sending the message

through policymakers like yourself, and really changing the paradigm here with coordinated activity of all of you and then also

within our Department.

Chairman TOWNS. As I understand it, the U.S. Preventive Task

Force issues a directive to CMS as to what screening and treatment for hepatitis will be covered by Medicare. How can we make

sure that the new treatments that you say are just over the horizon

will be covered by Medicare if the Task Force issues its directive

just before those treatments are ready?

Dr. KOH. Well, there are several parts to your question, Mr.

Chairman. First of all, within Medicare and Medicaid, actually,

there are new prevention opportunities afforded by health reform,

so that is a very exciting part of this new law. It gives us an opportunity to look at new prevention and screening strategies in a

whole host of areas.

The U.S. Preventive Services Task Force is, just to clarify, an

independent advisory group of experts, and they are one of a number of groups that make screening guidelines. So we look to them,

but also many other groups, to come out with recommendations.

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So I am hoping, again, that with this very important timing after

health reform, with this hearing, and with the establishment of our

Department interagency working group, we can bring all these prevention recommendations together and move forward as a country

to tackle this major challenge.

Chairman TOWNS. I just want to clear up one other thing that

was made in reference to earmarking by my good friend who I

work very closely with, that this would not be an earmark; this

would be expanding a program that is in existence that needs additional resources in order to accomplish the goals that we all are

seeking.

So I just wanted to make that clear. So what we need to do is

just fight to expand the program, which there is no question, anybody and everybody you talk to is saying that we need additional

resources.

I now yield to the gentleman from California, Congressman

Bilbray, for 5 minutes.

Mr. BILBRAY. Thank you, Mr. Chairman. Let me say, Mr. Chairman, as the Representative of the 50th District, which has had a

very checkered past when it comes to earmarks, I think this is one

of those issues why we really need to talk about a true reform

package, so the boundaries, lines are all drawn and everybody

knows where the rules are.

But that aside, I would like to sort of engage the two gentlemen

with some observations as a layman. First of all, for the record, I

avoided tattoos not because of health problems, but because my father, who was a lifer in the Navy, assured me that he would take

care of the tattoo with a rusty razor if I ever came home with one.

OK? [Laughter.]

But I do worry about the fact that I see that mentality not being

applied to the next generation, and that whole acceptability of certain behavior, some of it now totally acceptable, but does constitute

still expanded risk. I would like to see what we can do, rather than

just talking about how much money we can throw at the problem,

which I think, disproportionately, we are not getting a fair share

on this issue, but aside from that is that things like protocols for

testing.

I would strongly say that we need to get the word out to physicians that targeted populations should be looked at multidimensionally; not just inquiring about behavior, but looking at the population window. When we have that kind of number, any toxicologist

or statistician will tell you, you don’t ignore that kind of spike and

that kind of opportunity.

So, first of all, let me throw out some ideas as a layman, then

I will go into it. If I were still at the county, I would be telling our

county physicians that you should not be asking them how have

you had risky behavior in the past or whatever, because that automatically sets off defensive mechanisms. And it is astonishing how

those of us in our fifties and our sixties forget about our good old

days when we lived through the 1960’s, which most of us can’t remember anyway. [Laughter.]

But if we basically look at their age, use the age as an initial,

still you can followup on behavior for the general population, but

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as a backup not necessary, because I just think you will get defenses.

And the other issue is right now, and I say this, I had the county

physician because of a lot of exposure as a county supervisor. The

Mexican border was on my district; I spent a lot of time in Mexico,

and you know the horrendous problems with hepatitis south of the

border. I was inoculated as much as possible at that time. But the

treatment now, that exists now, is an IV treatment that is pretty

extensive. It is how many weeks?

Dr. WARD. Up to 48 weeks.

Mr. BILBRAY. OK, 48 weeks. One of the biggest problems I know,

especially with a lot of at-risk populations, is that when you talk

about that kind of treatment, they may start the treatment, but

the problem of finishing the treatment is always a big problem. The

same kind of things we run into with antibiotics with certain populations.

My question is when you do your evaluation, update your 2004

protocols, are you looking at the new treatments coming down the

pike that are being considered, especially I think there are about

three different proposals for oral treatment that is much shorter?

And it is a lot different going 7 weeks taking a pill than it is going

7 weeks going into a physician’s facility and getting a shot. Are we

looking at the fact that the treatment effectiveness is going to jump

dramatically if any one of these three becomes effective? And is

that going to be considered in our upgrade?

Dr. KOH. Sure, Congressman. First of all, thank you for your

commitment to this. We want the broadest possible approach here

to advance prevention, education, and treatment all at the same

time, so with respect to the prevention part there is new effort and

research to look at a so-called age-based model for identifying people at risk. Actually, Dr. Ward at the CDC has led that effort, so

I am going to ask him to comment on that in just a second.

Then, also, the treatments have advanced quite a bit, as you

have noted, and it does have the potential to decrease the duration

of treatment quite substantially for patients. So this is all good

news coming down in the very near future, I hope, and we want

to coordinate better identification of people at risk, whether it is

risk-based assessment or age-based assessment, and we also want

to advance better treatments. But I think Dr. Ward wants to say

something about this.

Dr. WARD. Good morning. We share your interest in looking at

alternatives to our current strategies for screening. We want our

screening approaches to be part of the solution, and not part of the

problem. And right now we have a fairly large body of evidence

that risk-based approaches represent barriers to people getting

screened, in contrast to presenting opportunities.

So what we have embarked upon is looking at an age-based approach, given that, to your point, upwards of about three-quarters

of persons living with Hepatitis C were born between 1946 and

1964, the so-called baby-boom generation. And among that age

group, about 1 out of every 30 people, or about 3 percent of persons

in that age group, are Hepatitis C infected. And we have embarked

upon a study known as BEST-C, to see if this could be easily

implementable by physicians.

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As we have already pointed out earlier today, Hepatitis C is a

major cause of liver cancer. We have other age-based prevention

strategies for other types of cancer: breast cancer, colon cancer. So

we would like to see how we could begin to look at how Hepatitis

C screening in the context of cancer prevention and begin to say

this is another age-based approach to protect someone’s health for

the future without requiring someone to go way back in the past

and say this happened, this happened, so then I am eligible for

screening. We would like to make it much more accessible and

much more easily implementable by physicians and, in so doing,

decrease this large proportion of people who currently don’t know

their status.

Mr. BILBRAY. I apologize. There is a big——

Chairman TOWNS. The gentleman’s time has expired.

Mr. BILBRAY. I appreciate it, Mr. Chairman. I just think that this

assessment from the update of 2004 and the fact that it is a very

complicated issue, and I hope some time we can talk about it,

about the fact of the difference of how expensive treatment is with

IV, how there are people that will not complete treatment, as opposed to the new technologies coming down, and how that affects

the whole formula.

Chairman TOWNS. I thank the gentleman. Time has expired.

The gentlewoman from California, Ms. Chu.

Ms. CHU. Thank you, Mr. Chair.

First, I want to commend you, Dr. Koh, for taking on this disease

so strongly. You are the first person in your position to raise this

amount of awareness and activity on combating Hepatitis B and C,

so I truly commend you on that.

It is a grave concern to me that in the U.S. hepatitis claims more

lives each year than HIV/AIDS and is about 100 times more infectious than HIV, yet only 2 percent of CDC’s prevention budget is

devoted to Hepatitis B and C.

It is also very disconcerting that Asian Americans are disproportionately impacted by this disease. Although APIs make up about

41⁄2 percent of the population, they account for more than 50 percent of Americans who are living with the disease and, in fact, it

remains a top killer of Asian Americans.

Many of these Asian Americans have immigrated from countries

in which they lack universal vaccination. They may have come here

without knowledge that they were carrying the disease and they

may have already developed a liver cancer. Pregnant mothers can

easily transmit the virus to their newborns, and that is how it is

being spread. And it is so prevalent that in the API population all

of us know somebody who is infected and, in fact, recently, in my

area, the mayor of our local city died because it did develop into

liver cancer.

So my question is what you are doing to address the particular

issues in the Asian-American community with this incredible prevalence of this disease.

Dr. KOH. Well, first of all, Congresswoman, thank you for your

leadership on not only this issue, but on so many issues for the

Asian-American and Pacific Islander community. I have seen your

commitment personally and I want to thank you for that.

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We understand that this condition of hepatitis disproportionately

affects the Asian-American and Pacific Islander population, so we

have a lot of challenges ahead of us, but we also have opportunities. One opportunity, as you well know, is the President has established a new White House initiative on Asian Americans and Pacific Islanders.

I took great honor in standing with the President when he signed

that Executive order last fall in the White House, and the first

meeting of that commission, which is co-chaired by Secretary Locke

and Secretary Duncan, is next month, in July. So we are going to

put this issue on the agenda there to have the White House commission address this squarely.

Then, we are also very lucky to have many leaders in the community, from the community health center organizations, advocacy

groups, outreach efforts spearheaded by committed people from

Asian-American and Pacific Islander backgrounds very involved

here, and then also tremendous research that is going on. And,

Congresswoman, you and I attended a very important event where

new health data was being released on Asian-American populations. That was a great event to share in. So there is a lot more

attention on documenting health concerns in our population and

then in mobilizing people who want to make a difference here.

Dr. WARD. Let me just add on to say I think some of the critical

areas of our prevention efforts as they relate to Asian Americans

include our perinatal Hepatitis B prevention program. As you

pointed out, mother to child transmission is a major mode. It continues to result in transmissions, resulting in hundreds of infants

becoming infected with Hepatitis B. Many of those are Asian Americans. The number of women, as noted in our written testimony,

has increased to about 24,000 per year who are Hepatitis B infected giving birth, and currently our perinatal programs have the

capacity to provide case management services for about 50 percent

of those.

We have the prevention tools to dramatically prevent transmission in this population through vaccination, Hepatitis B

immunoglobulin, but those services have to be available.

Ms. CHU. And how are we going to assure that the resources go

toward this sort of effort?

Dr. KOH. Well, again, we are, I think, mobilizing every resource.

Having this hearing is a tremendous statement of commitment

from policy leaders across the country. We have new energy from

this Department interagency workgroup. We have here at the hearing many people from community level and advocacy level who

want to make a difference. Research continues to go forward. And

then the health reform passage and implementation I think gives

us an opportunity to look at all these issues carefully and build a

real system of care.

As you heard from Dr. Ward, we are looking more closely on the

screening strategies, and there are also new testing technologies

that are being explored, rapid testing for Hepatitis C in particular.

I don’t know if Dr. Ward wants to say more.

Dr. WARD. I think the other critical area in general, but particularly as they relate to Asian Americans is, one, community awareness and education. You know, despite the high prevalence that

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you mentioned, awareness appears to be low, based on the information we have received.

And we need to correct that so that persons understand the benefits of vaccination and screening and early care, rather than waiting for liver cancer to develop. So we have done inventories to identify community organizations who are delivering prevention services for Hepatitis B around the country. We provided some resources to two areas to actually support screening for Hepatitis B

through those community organizations. So that is an important

opportunity.

The other critical area is provider education. If they are not

going to a provider that knows what needs to be done for hepatitis

after you have increased their awareness, you really haven’t done

a full job. So we have to link our community education with provider training so that, when people go to a physician, that physician knows who should be screened, how to interpret the screening

test, which sometimes can be complex, and then knows how to interpret that test result and determine who needs care and treatment for hepatitis.

Chairman TOWNS. Let me indicate to the Members that we have

three votes on the floor and, of course, I want to yield to the gentleman from Missouri. So, we will try to finish up with this panel

and we will resume at 12:15. We will come back at 12:15.

OK, so I now yield 5 minutes to the gentleman from Missouri.

Mr. CLAY. Thank you, Mr. Chairman, and I will be more judicious with my 5 minutes, unlike my colleagues, seeing that there

is a vote.

Dr. Koh, I know that you have been very persistent about developing an interagency strategy to address this health crisis. In your

view, what are some of the challenges that an initiative like this

may face?

Dr. KOH. Well, we have a big Department that has many responsibilities being put before us. When I arrived at the Department

last year, we had H1N1 ahead of us and now, of course, we have

health reform implementation. But the opportunity, I believe, is

that we have really a unique and unprecedented chance to make

a difference with respect to conditions like hepatitis, with respect

to prevention, and really building systems of care.

Also, if I can say, we have had tremendous leaders in the Department like Dr. Ward and officials at CDC. We have had work at

agencies like NIH and the National Cancer Institute. Also, reimbursement discussions at the Centers for Medicare and Medicaid

Services. But not that many chances to bring all those leaders and

our Department together to really see how it could work together.

If I can say the leaders at SAMHSA, Substance Abuse and Mental

Health Services Administration [HRSA], Health Resources Services

Administration, we have pockets of activity, but now a real chance

to bring everybody together and see how we can coordinate this.

Mr. CLAY. Do you have a working group?

Dr. KOH. Yes. We met since January, Congressman. I chaired

those. Dr. Ward has been at every meeting. I should also acknowledge Rosie Henson, our Senior Advisor, who has been instrumental

in launching this. We have great commitment now across the Department and we are very proud of that.

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Mr. CLAY. And I realize that this administration does quite a bit

with interagency strategies. How has that worked in this case?

Dr. KOH. Well, we are going to focus within the Department until

October, when we get our internal coordination heightened, and

then we are very eager to work across Federal Government and

then particularly connect with community partners. Many community partners are here today, Congressman, and they have been

working on these issues for a long time, and they have a lot to

teach us, so we are looking forward to working and connecting all

interested parties because this issue is so important.

Mr. CLAY. Very good.

Dr. Ward, according to the recent IOM Report, African-American

adults have the highest rate of acute Hepatitis B infection in the

United States, and the highest rate of acute Hepatitis B infection

occurs in the south. What does HHS plan on doing to address this

population?

Dr. WARD. We have an elimination strategy for Hepatitis B. We

have a powerful prevention tool, Hepatitis B vaccination. It is safe.

It is effective. The Nation committed itself to eliminating transmission of Hepatitis B virus way back in 1992. We have made

progress, as Representative Cassidy said; it was mainly around

children.

And over and above the mother to child transmission population

that still needs to receive fuller attention, the other big gap in our

immunization strategy is adults at risk for Hepatitis B, and those

low vaccination coverages are the major reason that African Americans continue to have high rates of Hepatitis B.

Mr. CLAY. OK. And then there are many other disparities that

exist within this epidemic, including greater rates of infection for

many minority groups and the LGBT community. Are there specific

strategies in place to address each of these groups? And, if so, how

does it differ?

Dr. WARD. Well, we have put out recommendations from CDC of

which populations among adults need to receive Hepatitis B vaccine, such as men who have sex with men, injection drug users,

persons with multiple sex partners. We have, over the last several

years, put out about $45 million in money to help public settings—

STD clinics, local health departments, correctional facilities—to receive Hepatitis B vaccine at little or no cost so that vaccine could

be used to vaccinate populations which have been shown repeatedly

over years to have low coverage, including the ones I just mentioned. So we would like to continue to advance improvements in

vaccine coverage, which would then be followed by declines in Hepatitis B.

The other aspect of this is that African Americans also——

Chairman TOWNS. Dr. Ward, we have to cut you real short here

because we only have a minute and a half to vote.

Mr. CLAY. He gives pretty long answers, Mr. Chairman. [Laughter.]

Chairman TOWNS. We have to cut you short.

But, anyway, I want to thank both of you for your testimony. We

are going to dismiss you and the committee will be in recess until

12:15, as close to 12:15 as we can. Then we will be back. But thank

you so much for your testimony.

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Dr. KOH. Thank you, Mr. Chairman.

Dr. WARD. Thank you very much.

Chairman TOWNS. Pleasure.

[Applause.]

[Recess.]

Chairman TOWNS. Let me thank you very much for coming. Mr.

Randy Mayer is here on behalf of the Institute of Medicine and

serves as the chief of the Bureau of HIV, STD, and Hepatitis for

Iowa Department of Public Health; Mr. Jeffrey Levi is the executive director of the trust for America’s Health organization; Mr. Michael Ninburg is the executive director of the Hepatitis Education

Project in Seattle, WA; and Mr. Rolf Benirschke is spokesman for

Hepatitis C Awareness.

Consistent with committee policy, we would like to ask you to

please stand and let me swear you in.

[Witnesses sworn.]

Chairman TOWNS. Let the record reflect that all of the witnesses

answered in the affirmative.

Let’s begin with Mr. Mayer and then come right down the line.

STATEMENTS OF RANDY MAYER, CHIEF, BUREAU OF HIV, STD,

AND HEPATITIS, IOWA DEPARTMENT OF PUBLIC HEALTH,

APPEARING ON BEHALF OF THE INSTITUTE OF MEDICINE;

MICHAEL NINBURG, EXECUTIVE DIRECTOR, HEPATITIS EDUCATION PROJECT; JEFFREY LEVI, EXECUTIVE DIRECTOR,

TRUST FOR AMERICA’S HEALTH; AND ROLF JOACHIM

BENIRSCHKE, FORMER NFL PLACE KICKER, SAN DIEGO

CHARGERS, AND SPOKESMAN FOR HEPATITIS C AWARENESS

STATEMENT OF RANDY MAYER

Mr. MAYER. Good afternoon, Mr. Chairman and members of the

committee. My name is Randy Mayer. I am Chief of the Bureau of

HIV, STD, and Hepatitis at the Iowa Department of Public Health.

I also served as a member of the Institute of Medicine’s Committee

on the Prevention and Control of Viral Hepatitis Infections.

The Institute of Medicine [IOM], is the health arm of the National Academy of Sciences, an independent nonprofit organization

that provides unbiased and authoritative advice to decisionmakers

and to the public. The IOM was asked by the Centers of Disease

Control and Prevention, the Department of Health and Human

Services Office of Minority Health, the Department of Veterans Affairs, and the National Viral Hepatitis Roundtable to review current prevention and control strategies for viral hepatitis and to

identify priorities for research policy and action.

The IOM assembled an expert committee, of which I was a member, to address this task. The committee met five times over a 12-

month period to gather evidence, deliberate on its findings and recommendations, and write the report. The report was released in

January of this year, and more detailed information is included in

my longer written statement.

You have heard much of what the report discussed earlier today

from our other speakers, but the committee learned that in the

next 10 years about 150,000 people in the United States are expected to die from liver cancer and liver disease associated with

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chronic viral hepatitis. This condition is three to five times more

frequent than HIV in the United States. Between 31⁄2 million and

5.3 million people, or 1 to 2 percent of the population of the United

States, are living with Hepatitis B or C. Those numbers are unacceptably high considering that Hepatitis B and C are both preventable and treatable.

Unfortunately, about 65 percent of people with Hepatitis B and

75 percent of people with Hepatitis C do not realize that they have

the disease. By comparison, about 21 percent of people who are

HIV infected do not realize that they have HIV. This means that

the majority of those with viral hepatitis are not seeking treatment

or taking steps to prevent transmission of the disease to others.

Hepatitis B and C are transmitted by sexual contact and by exposure to infected blood through the use of contaminated needles

or other drug equipment and implements. In addition, approximately 1,000 infants per year are infected with Hepatitis B during

birth, and people may have acquired Hepatitis C through blood

transfusions and transplants that occurred before 1992.

After reviewing a great deal of evidence, the committee identified

several underlying factors that impede current efforts to prevent

and control Hepatitis B and C. The primary factor is the lack of

awareness about viral hepatitis among the general population and

among health care and social service providers. This lack of awareness translates into a lack of public resources that are allocated for

Hepatitis B and C. States receive, on average, only $90,000 annually in Federal funds for hepatitis prevention among adults.

Because chronic viral hepatitis has not been a public health priority in the United States, at-risk people do not know they are at

risk and, therefore, they do not take steps to prevent infection or

to get tested for any infection. Many health care providers, especially primary care providers, also are not familiar with risk factors

for Hepatitis B and C. Therefore, they do not screen patients for

risk factors to determine if they should be tested. In addition,

many health care providers don’t know how to manage chronically

infected patients.

The committee believes that to address this national epidemic,

additional Federal resources and guidance are necessary in four

specific areas: disease surveillance, provider and community education, Hepatitis B immunization coverage, and viral hepatitis

services. Action is needed at the Federal, State, and local levels to

address the problem. In fact, 17 of the IOM committee’s 22 recommendations are aimed at Federal and State agencies, including

the CDC and the Health Resources and Services Administration.

In conclusion, the IOM committee believes that increased funding and a coordinated national effort would lead to reductions in

new cases of Hepatitis B and C, in medical complications, and in

deaths associated with these diseases and in total health costs.

Thank you.

[The prepared statement of Mr. Mayer follows:]

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Chairman TOWNS. Thank you for your statement.

Mr. Ninburg.

STATEMENT OF MICHAEL NINBURG

Mr. NINBURG. Thank you, Chairman Towns, committee members,

for inviting me to testify here today. My name is Michael Ninburg,

and I am the executive director of the Hepatitis Education Project,

a nonprofit organization based in Seattle, WA. I also serve on the

steering committee of the National Viral Hepatitis Roundtable, a

coalition of nonprofit organizations, public health districts, and industry partners representing groups around the country. Until very

recently, I was also a hepatitis patient.

As we have heard several times this morning, there are over 5

million Americans currently living with Hepatitis B or Hepatitis C,

the overwhelming majority of whom are unaware of their infection.

Being unaware, they can unwittingly transmit the viruses to others, and often do things to speed up their own disease progression.

Twelve years ago, in this very same committee, Surgeons General Satcher and C. Everett Koop spoke of Hepatitis C as a serious

public health threat. You were here, Chairman Towns. Hepatitis B

is also a grave public health threat. We still have an opportunity

to address these issues, but that window of opportunity is closing.

For those who are diagnosed early for Hepatitis B and C, the

prognosis is usually very good. Hepatitis B and Hepatitis C are

both treatable conditions, and Hepatitis C is often curable. For people to be treated, however, they have to be diagnosed. This remains

one of our greatest challenges.

I was one of the fortunate who was diagnosed. I am also fortunate that I have access to excellent medical health care. In January

2009, I entered a clinical trial looking at promising experimental

new drugs for Hepatitis C. The virus rapidly became undetectable

in my system and I completed treatment in December of last year.

Just a few weeks ago, I received my final lab results and was told

that I am cured. I happily used the past tense now when I say that

I was a hepatitis patient. Sadly, still many Americans are unable

to say that.

My story is the one I know best, but it is not the one that is most

important to me. That would be the story of my wife and my boy,

Sasha. I met my wife, Lilly, in graduate school, and shortly after

we met I told her that I had Hepatitis C and explained to her what

that meant and how it was transmitted. Later I explained that

there was another epidemic that was silent and largely unknown

to the general public, and that was Hepatitis B. I knew that among

the groups at greatest risk were those born in countries where

Hepatitis B is endemic. One of those countries is China. That is

where my wife, Lilly, was born.

I asked her if she had ever been tested for Hepatitis C, and she

said that she didn’t know. I suggested that it would be a good idea

for her to get tested. Eventually she did, and she learned that she

had chronic Hepatitis B. Inactive, she was told, but as she got older

she would need to be screened for liver cancer to make sure that,

if she did develop liver cancer, it was caught early. If caught early,

it is very treatable. Because she was tested, her prognosis is very

good.

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I would like to end my statement today on a note of optimism.

There are gaping holes in this country’s response to viral hepatitis.

That is why we are here. There are, however, examples of successful lifesaving initiatives that we can look to for inspiration. Since

the early 1990’s, there has been a recommendation in the United

States that all pregnant women get tested for Hepatitis B and all

babies born to Hepatitis B positive women be given a series of protective vaccinations within the first 12 hours of birth.

A pregnant woman will transmit Hepatitis B to her newborn 90

percent of the time. However, if that newborn gets the series of

shots, he or she will almost always develop immunity and not go

on to develop chronic infection. As a result of this initiative, we

have seen new Hepatitis B infections in the United States plummet

since the early 1990’s. Also as a result of this initiative, my little

boy was given a lifesaving series of vaccinations that spared him

the potential fate of dying from liver cancer.

Ultimately, that is what this is about. It is about a little boy who

gets to grow up with both parents. It is about a mother and father

who don’t have to worry that they might outlive their children. It

is about brothers and sisters and cousins and friends who don’t

have to bury a loved one after watching that person die a long, horrible death for end-stage liver disease or liver cancer.

I look forward to taking your questions.

[The prepared statement of Mr. Ninburg follows:]

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Chairman TOWNS. Thank you very much.

Dr. Levi.

STATEMENT OF JEFFREY LEVI

Dr. LEVI. Thank you, Mr. Chairman and members of the committee. I am Jeff Levi. I am executive director of trust for America’s

Health. We are a nonprofit, nonpartisan advocacy organization.

As you have heard this morning, hepatitis is, in a sense, a ticking time bomb. Over 5 million people in the United States are infected with Hepatitis B or C and an estimated 65 percent to 75 percent are not aware of their status, putting them at risk for developing chronic hepatitis, liver cancer, cirrhosis, or late stage liver disease.

With promising new treatments on the horizon, that could dramatically improve our chances for effectively treating these individuals. We have a moral obligation to make sure that all who can

benefit know their status and have access to the care and the end

result that Mr. Ninburg had.

However, this is more than a moral argument. It is also a practical financial issue for our reforming the health care system. The

direct annual medical costs associated with HBV and HCV have

been estimated at $7.6 billion. If we continue down the present

course of late identification of people with viral hepatitis and,

therefore, advanced disease upon entering treatment, the cost to

the health care system will continue to grow.

Indeed, one study has estimated that annual medical costs for Hepatitis C alone could increase to $85 billion a year in 20 years,

with Medicare taking on 39 percent of those costs. If we undertake

aggressive actions such as those I am about to outline, we can dramatically change that equation for the better.

The United States needs a comprehensive policy response to this

problem, and I am hopeful that the panel chaired by Dr. Koh, when

they release their report in October, will include at least some of

these elements.

First, we need much better situational awareness and surveillance. We do not have sufficient data regarding the scope of the

problem and who is affected. This affects not only our ability to

prevent and treat disease, but it also creates a vicious cycle of inadequate evidence to support greater public resources to address the

problem.

Second, we need to routinize screening for Hepatitis B and C so

hepatitis-positive individuals learn their status and are linked to

appropriate care. For HBV, providers and patients need to have

better awareness of who is at risk and assure they get screened,

including all pregnant women. For Hepatitis C, it is time to move

to include nation of birth and age, not just behavioral factors. As

we heard earlier this morning, it should not strictly be behavioral

factors as the basis for screening, as many adults are unaware that

the behaviors of their youth have put them in danger of infection.

Third, we must assure that the reformed health care system provides quality prevention and care for hepatitis, from screening and

preventive services mandated for all plans, to HHS putting in place

the appropriate policies that guarantee quality care for people with

hepatitis. With health reform and near-universal coverage, it really

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means that people will have the opportunity to take advantage of

these new treatments.

Fourth, we must assure that people stay in care with appropriate

support services that will assure adherence to treatment. These

services are especially important for marginalized populations such

as immigrants, incarcerated individuals, or injection drug users.

Although many of the adherence issues are similar, our health care

system has been much more effective at assuring adherence for

HIV than for Hepatitis C. This is in part due to the additional

services supported by the Ryan White Program. Just as with HIV,

there is a strong public health rationale for assuring successful

completion of hepatitis treatment with these kinds of support services.

Fifth, as we focus on assuring treatment, we must also remember

that there are major opportunities for primary prevention of hepatitis. We continue to see pockets of outbreaks of Hepatitis B and

Hepatitis C. We must close the gaps in Hepatitis B vaccination coverage and use all educational and structural tools at our disposal

to prevent transmission of Hepatitis C. This includes Federal funding of syringe-exchange programs. While we are delighted that

Congress has lifted the ban on States and localities opting to use

exchange programs as part of their fight against hepatitis and HIV,

we are disturbed by the delay in HHS issuing guidance to implement this change in policy.

Sixth, within the area of primary prevention, we have within our

reach the capacity to virtually eliminate mother-to-child transmission of Hepatitis B. One thousand newborns in the United

States become needlessly infected with Hepatitis B each year.

HRSA, CMS, and CDC must all work to incentivize routine HBV

screening of all pregnant women and assure appropriate interventions with newborns.

Finally, there needs to be an increased emphasis on research. In

addition to research for better treatments, we desperately need to

understand the reason for the disparate response to HCV treatments. African Americans have the highest rates of Hepatitis C in

the United States, more than twice that of Whites. Yet, treatment

is nearly half as effective in African Americans as compared to the

general population. We need to require that clinical trial cohorts

are diverse enough to assure that we know the safety and efficacy

of new treatments for all who are affected by hepatitis.

We are at a critical juncture in our Nation’s fight against hepatitis. New treatments offer great promise. Reforming the health

care system will improve coverage and access and, in the case of

Hepatitis B, we have a vaccine that could effectively eliminate it.

Chairman TOWNS. Doctor, could you summarize?

Dr. LEVI. The question remains whether, as a Nation, we will

seize this moment. Thank you.

[The prepared statement of Dr. Levi follows:]

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Chairman TOWNS. Thank you.

STATEMENT OF ROLF JOACHIM BENIRSCHKE

Mr. BENIRSCHKE. Mr. Chairman, my name is Rolf Benirschke.

committee, thank you so much for having us out here. I am a little

tired. I look tired; I apologize for that. I took the Red Eye out this

morning from San Diego; arrived, shaved in the airport, changed

clothes, and am thrilled to be here. I am thrilled because of what

you are doing.

In a former life I was a kicker. For 10 years I was a kicker for

the San Diego Chargers; played under Don Coryell, the Dan Fouts’

years. As a kicker, my job was usually to come in at the end of the

game and sort of try to kick it through the uprights.

Today we have heard three panels of incredibly distinguished,

knowledgeable people share with you all of the issues. They are out

on the table; we know them. My job today is to share with you from

a patient’s perspective how this virus actually occurs.

By way of background, I am an immigrant’s son. My dad came

over, learned the language, ended up going to Harvard, ended up

teaching at Harvard, became a world-renown pathologist; left Hartford to go to Dartmouth and moved our family to San Diego, where

he teaches at the Medical School at UCSD. I have been around academic medicine my entire life. But I am the black sheep of the family. My older brother is an orthopedic surgeon and I was drafted

into the NFL. My dad wondered where he went wrong. [Laughter.]

Things changed, though. In my second season with the Chargers,

I came down with an illness, originally diagnosed as having

Crohn’s Disease; it was later amended to ulcerative colitis. But it

would require four major abdominal surgeries, two within 6 days

of each other, and my weight dropped from 187 pounds to 120

pounds and I wasn’t supposed to live. I needed 80 units of blood

to survive. That same blood, I would find out 12 years later, that

saved my life put my life in jeopardy.

I was able to return to the game, played seven more seasons,

wore an ileostomy bag for four of those years and became very involved in raising awareness for people with inflammatory bowel

disease and those facing ostomy surgery. I learned that one person

can make a difference.

Fast forward my life to getting married and having children.

Twelve years ago, after adopting two children and having one, we

had our fourth, and I went in for a routine life insurance exam and

was told by one carrier that I had a preferred rating, but the other

carrier called me and said your liver enzymes are slightly elevated,

we would like you to get retested. Feeling good, in good shape, continuing to work out, I was not worried in the least; went and got

reexamined. Was brought into the physician’s office and, like a 2

by 4 to my head, I was told I was infected with the Hepatitis C

virus.

At that moment, I was scared to death. My previous illness just

involved me and my silly career. This illness now affected a wife

and four kids who were depending on me, and it became real. I felt

like I was handed a death sentence; didn’t know anything about

the virus, felt unclean. How did I get it? Decided to take my family

on a 6-week trip. We rented a motor home and drove around the

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west of the United States, Grand Canyon, visited a bunch of scenic

places. Built some memories, scared that this might be the last

time I had with my family. But at the end of that trip came back

and, with my wife, made a commitment to understand as much as

I could about this virus and fight it.

Fortunately, I was under good medical care; found a hepatologist

who was as passionate about fighting this disease as I was about

getting rid of it, and I started on a clinical trial. That was 12 years

ago. That clinical trial cleared the virus while I was on the treatment, but a month after going off the treatment the virus came

back. That trial involved a daily injection of interferon, coupled

with an antiviral pill.

After getting the news that I had had the virus come back, my

physician sat with me and said there is another molecule out there,

a different interferon molecule. If you are willing, I think you

should go on treatment. So 3 months later I went on a second

course of treatment; daily injection, maximum dose, antiviral pill,

and went through all the side effects for another year. Cleared the

virus while I was on the treatment, and then a month after going

off the virus came back.

Now twice defeated, but buoyed by the knowledge that my reason

for going on treatment was still there, a wife and four children, I

waited. Now, fortunately, there are other people that have joined

our fight, like the government is joining our fight now. There are

pharmaceutical companies out there that are advancing research,

and 4 years later there was a new treatment, a pegylated

interferon, one that required a weekly injection instead of a daily

injection; better understanding of how the virus is fought. I went

on that treatment. It was a year-long treatment coupled with an

antiviral. The 1-month post test came back clear. The 3-month post

test came back clear.

Chairman TOWNS. Mr. Benirschke, I am going to have to ask you

to summarize, and the problem is, if I don’t, I will have to ask you

to wait an hour and 45 minutes before we come back.

Mr. BENIRSCHKE. I don’t want to do that, sir.

Chairman TOWNS. OK.

Mr. BENIRSCHKE. I will summarize. [Laughter.]

Chairman TOWNS. I figured that would encourage you.

Mr. BENIRSCHKE. Yes. The 6-month treatment came back virusfree, which means I am free of the virus. I am cured.

I am here to thank you for what you are doing. I am here to support all of the things that have been spoken about, the need to

raise awareness. Not just raise awareness; to get screened, raise

awareness, and then to do something about it. We have, as Congressman Bilbray suggested, a great opportunity to make a difference. There are treatments out there and I just want to thank

you again on behalf of all of us for what you are doing.

[The prepared statement of Mr. Benirschke follows:]

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Chairman TOWNS. I want to thank all of you for your testimony.

Let me say to the Members we have a business meeting, and if

we can start right now, we can actually do it and it would be over,

and then go and vote. That way we won’t have to come back in an

hour and 45 minutes or 2 hours. So, if that is OK, we will move

forward.

Let me thank you again for your testimony. We will probably ask

questions for the record, but we are going to have to break at this

time because of our voting schedule. So thank you very much, Dr.

Mayer, Mr. Ninburg and Dr. Levi.

Ms. WATSON. Mr. Chairman.

Chairman TOWNS. Yes.

Ms. WATSON. May I make one comment? Because the next bill

is mine.

Chairman TOWNS. Yes.

Ms. WATSON. I just want to say the major research on interferon

has been done down at the medical school and hospital in Cuba,

and that is what is sustaining the life of Fidel Castro who had

stomach cancer and was expected to die. So had he been able to

come to the international research forums and been invited, we

would have had interferon in use in clinical trials and other places

in our country. So thank you so much.

Chairman TOWNS. Thank you, gentlelady from California.

This panel is actually dismissed. Thank you for coming and your

testimony. We do not want to hold you an hour and 45 minutes,

so we are going to let you go now. OK? Thank you. You can be excused.

The hearing is now adjourned.

[Whereupon, at 12:47 p.m., the committee was adjourned.]

[The prepared statements of Hon. Jackie Speier and Hon. Anh

‘‘Joseph’’ Cao and additional information submitted for the hearing

record follow:]

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